Fascinating article in today's Wall Street Journal (A2 column). Thanks to a very nice reader who called my attention to the column. For those with a subscription - The Misconceptions About Drug Prices

The Bush administration thinks more of the free market would be better, and makes one observation that hasn't received much public attention. Brand-name drug prices are lower abroad because governments won't let the market set prices, but prices of generic drugs -- those for which the patent has expired -- are higher for the same reason. He argues that other countries deny themselves the benefits of cheap generics. While generics account for half of all prescriptions in the U.S., they are less than 40% in Canada and less than 10% in France, he notes.

The point, too often overlooked in the debate about allowing more imports of prescription drugs, is that the U.S. will run into trouble if it tries to adopt only parts of other countries' approach to drug prices.

The U.S. spends more on drugs: $556 per person in 2000 versus $473 in France, $385 in Canada and $252 in Australia, the Organization for Economic Cooperation and Development reports. But because the U.S. spends even more on other health care, drugs are a bigger share of health spending elsewhere: 12.4% of all health spending in the U.S. versus 21% in France, 16.2% in Canada and 13.8% in Australia.

These data certainly stimulate ones thinking. We do want less expensive trade name drugs. The goal seems reasonable. However, we can function well within the current system. We (physicians) have a great array of generics to prescribe. Judicious use of generics will certainly help patient expenditures on drugs.

Cheaper drugs or siren songs?

Next week, the Department of Health and Human Services's Medicare drug card discount Web site is going to go "live," giving seniors the first chance to shop for the lowest prices for drugs under the new program — which also includes about $8 billion in cash, about $4 billion in discounts and billions more in direct benefits from biotech and pharmaceutical companies themselves. All told, millions of seniors will wind up paying less for drugs than they pay in Canada, or even next to nothing.

Yet, critics of the card and groups like Families USA are actively telling seniors they won't save any money because any discounts will have been eaten up by huge price increases now and in the future. They — along with the governors of many states — are instead pushing for the importation of medicines at government-controlled prices or for outright federal-price regulations.

Here are the facts about the Medicare drug discount program. All seniors are eligible to sign up for cards providing average discounts of about 20 percent on all drugs. In addition, 10 million seniors making less than $16,000 a year will get $600 to buy drugs and, depending on the card they choose, can be automatically enrolled in drug and biotech company programs that will cover the rest of the cost of medicines for about $25 a month or less.

The Families USA response? A "road show" that includes as its centerpiece a video narrated by Walter Cronkite that tells seniors that drug companies have raised drug prices by 15 percent a year, while drug discounts will only be 10 percent a year. The implicit message to old folks: Why bother signing up? Wait for the price-control revolution and drug imports to see the "true savings."

As usual, politics dominate. I have not researched these drug cards sufficiently to understand the benefits or drawbacks. I suspect that the truth lies somewhere in the middle.

As a physician, my major responsibility remains knowing drug costs and lower cost alternatives. We try to teach our residents about drug costs and how to minimize costs while meeting therapeutic goals.

We should emphasize several principles. New is not necessarily better. The newest PPI (Nexium) should never be a drug of first choice. One should switch to a more expensive drug only when the data clearly show an advantage, and the less expensive drug has failed. Try to minimize the number of prescriptions for each patient.

If we remember those principles we can help patients afford their medications without making them choose between food and medications.

I suspect that the drug cards will help some patients. This strategy seems to have more "staying power" than the drug importation strategy (which will likely fail for economic reasons).

I found this link on theheart.org (which is heavily underwritten by pharmaceutical companies) - The Dawn of McScience. Just one quote to give you the sense of this long polemic.

Even scientific journals, supposedly the neutral arbiters of quality by virtue of their much-vaunted process of critical peer review, are owned by publishers and scientific societies that derive and demand huge earnings from advertising by drug companies and from the sale of commercially valuable content. The pressure on editors to adopt positions that favor these industries is yet another example of the bias that has infiltrated academic exchange. As editor of The Lancet I have attended medical conferences at which I have been urged to publish more favorable views of the pharmaceutical industry. For Krimsky, "the idea that public risk (that is, publicly supported research) should be turned into private wealth is a perversion of the capitalist ethic." The Pope would probably agree.

Certainly this quote does not do justice to this long piece. If the subject interests you, I recommend reading and considering the problem of the pharmaceutical industry its influence on academe.

For long time readers, this essay reflects issues that we have discussed several times. For new readers, read this NY Times piece, and then read my former rant on this topic.

When Your Doctor Goes to the Beach, You May Get Burned

Gifts

I will reiterate my position on pharmaceutical gifts. I accept anything that costs less than $10, e.g., lunch at noon conference, a pen (although I generally discard it after clinic), a pad of paper. I go to NO pharmaceutical company sponsored events - talks, golfing, consultations. I did some of these activities many years ago - then as I learned about influence, I understood that I was not immune from drug company manipulations. Thus, I had to distance myself.

From the NY Times piece:

Relatively few researchers have investigated the question of exactly what that something big is. Among other considerations, it is one of the few research topics in medicine that will not attract drug company financing.

A handful of studies have looked at the common practice of giving doctors free drug samples and have shown that it unquestionably induces them to prescribe drugs they would otherwise avoid. The other gifts also appear to bring a nice return. In one clever 1992 study published in the journal Chest, Cleveland researchers surreptitiously tracked doctors' use of two drugs before and after all-expense paid educational jaunts to sunny resorts. They found that drug prescriptions more than tripled, an effect that persisted for more than a year, while the use of equivalent drugs remained stable.

It is all quite deplorable, my friend says. He used to add routinely that none of this data was applicable to him, but a recent series of events may have changed his mind.

For those who want to understand why drug company gifts work please read Cialdini's work starting with this web site devoted to the psychology of influence - Influence at Work. If you are intrigued I highly recommend his book - Influence: The Science of Persuasion.

No ranting - just a link - Pop That Pill This is how the article ends - the leadup is worthwhile also -

Is all of this bad? Not entirely. There is some notion of empowerment that goes along with being a medical consumer rather than a mere patient. Sure, drug companies are trying to persuade you, but that in itself means they are investing you with the power of decision-making. It means you are being emboldened to discuss alternatives with your doctor without being concerned that you will be patronized, as patients routinely were in the Marcus Welby era. But with empowerment comes increased responsibility. How many people have the insight or time to look at the published research before confronting their doctors with what they think is the drug they ought to be taking?

One doctor told me he's gotten tired of arguing with those of his patients who insist on an inferior or inappropriate drug because they liked the advertisement. "I don't make a case for or against individual treatments anymore," he said, "no matter how much I may disagree, It takes away time I need to deal with other patients. I just flat out give my opinion, and they can take it or leave it. But considering that I'm the one with the M.D., if I were the patient, I'd listen up."

Are there benefits to having a more informed patient base? "Informed is a loaded word," this doctor said, "Informed about what? The ads usually end off by saying, 'Ask your doctor,' but the message they're really conveying is, 'Tell your doctor.'"

Tell the consumers about side effects! US FDA Wants Ads for Medicine to Highlight Risks

Prescription drug advertisements should highlight key risks rather than just list a string of possible side effects in tiny print, U.S. regulators said in new guidelines unveiled on Wednesday.

"Consumers want and deserve information presented in a way that's clear, accurate and understandable," Food and Drug Administration Commissioner Mark McClellan said.

To which I must clap wildly! Now let us have the same guidelines for supplements and then I will do a jig!

Drug Companies Get Too Close for Med School's Comfort

Studies indicate that most physicians meet with pharmaceutical representatives four times a month.

Studies also reveal that most physicians erroneously believe the representatives do not influence prescribing habits.

When doctors and trainees meet with reps, they change their prescribing habits and are far more likely to prescribe the drugs described, even when they are more expensive or have no benefit over alternatives. They are also more willing to request illogical changes to hospital guidelines that govern which drugs can be prescribed.

Estimates suggest that roughly $1 billion was spent advertising antidepressants to health professionals in 2000.

More than 400 psychiatrists were asked by Dr. Timothy Peterson and his colleagues at Harvard to describe their beliefs about antidepressants. More than half said they believed that newer agents were more effective than older antidepressants known as tricyclic antidepressants and that newer antidepressants, called selective serotonin reuptake inhibitors, or S.S.R.I.'s, had fewer side effects than generic S.S.R.I.'s.

But studies conducted at Oxford, Duke, the University of Manchester and the Canadian Coordinating Office for Health Technology that used a statistical strategy called meta-analysis to combine the results of hundreds of independent studies found that S.S.R.I.'s were as effective as tricyclic antidepressants or slightly less effective. They also revealed that S.S.R.I.'s were tolerated by slightly more patients but had as many side effects.

As usual I have mixed feelings when it comes to the pharmaceutical companies. While I personally work hard to distance myself from drug reps, I do understand the importance of the industry. This article presents a biased opinion against the pharmaceutical industry. But much of the content is accurate.

A reader sent in this link. It is a good one. Foregone conclusions

The public is being regularly deceived by the drug trials funded by pharmaceutical companies, loaded to generate the results they need

A reader posted this comment/question today:

Hi Medrants,

Your salary won't be increasing with the ridiculous cost of drugs. The notion that extremely expensive ACE-I are either no better or potentially less effective than thiazide diuretics represents a huge waste of ((LIMITED)) health care dollars. Please choose one of the following:
1) Stick with your current salary and prescribe whichever antihypertensive you like.

2) Prescribe thiazides first line and advocate some of the money previously wasted on ACE-Is goes to help providing comprehensive outpatient care.

1 or 2 ?

First, I learned many years ago that hypotheticals are dangerous. Lawyers love to pose them to make rhetorical points. They are tricky to answer.

This question has several flaws. First, ACE inhibitors are no longer ridiculously expensive. Second, for many patients they may even save costs (i.e., less CHF, less progression of CAD, less onset of diabetes mellitus). Thus, the question as framed lacks coherence.

Please refer to my many commentaries on ALLHAT. Diuretics rarely control BP alone. Most patients require two drugs for adequate control. In many subgoups the evidence supports ACE inhibitors plus a diuretic as the best combination.

My critiques of ALLHAT stem from designing a study which does reflect practice. If an ACE inhibitor alone does not control the BP, the next logical drug is a thiazide diuretic. Almost any class of antihypertensives benefits from adding a thiazide.

To me the importance of ALLHAT is that thiazides do work. However, when one adds all additional evidence, many subgroups - type II diabetes mellitus, proteinuric chronic kidney disease and known CAD in particular - have great benefit from an ACE inhibitor. I generally start with an ACE inhibitor, and quickly add a low dose of a diuretic if adequate pressure is not achieved with an ACE alone. ALLHAT does not provide the data for that treatment plan, because it was designed for a different less important question.

Derek Lowe is always good. This rant exceeds even his high standards. Things Only a Friend Can Tell You. Please go read it.

For those interested, this links to today's Letters to the Editor about the pharmaceutical industry and medical education. They are solid, but our commentary surpasses. The Doctors and the Drug Makers (6 Letters)

Your Doctor's Drug Problem written by Arnold Relman - former editor of the New England Journal of Medicine.

Relman identifies the problem of drug company controlled CME, but overextrapolates the evil.

To renew their licenses, doctors in almost all states are required to enroll in continuing medical education programs, and these are now largely subsidized, directly or indirectly, by the pharmaceutical industry. There are official guidelines for keeping these programs free of commercial bias, but they are voluntary. Most of these educational programs are presented by industry-friendly experts who are selected and paid by the companies selling the drugs being discussed, and most of their talks emphasize the medical benefits of those drugs. Some of this information is useful, but much of it is simply marketing disguised as education.

Let us clearly understsand the problem. Often drug companies will sponsor a speaker on a topic. The speaker will talk about an issue relevant to the company's drug. Some talks almost blatantly cheerlead for a particular drug. Other talks just increase awareness of the entity that the drug treats.

There are multiple levels of hell. We can modify our current system to disallow the most egregious talks, while preserving the true contributions.

I agree that we have a problem. I disagree with the extent of that problem. I disagree with Relman's assertion

So it is not merely that the pharmaceutical industry is using doctors to sell its products. Medical schools and other educational institutions are not teaching doctors how to use drugs wisely and conservatively. Until they insist that the pharmaceutical industry stick to its own business (which can include advertising but not education), we are unlikely to get the help we need from our doctors in controlling runaway drug expenditures.

I hear many talks at medical schools which do teach physicians how to use drugs wisely and conservatively (and I even give some of those talks myself). We have a problem, but many educators are addressing the issue.

So read his op-ed, but try to keep his thoughts into perspective, avoiding the hyperbole.

Wow! The Lancet has laid down the gauntlet. The statin wars: why AstraZeneca must retreatThe editorial ends:

Since there are no reliable data about efficacy and safety--and AstraZeneca is facing unusually acute commercial pressure to force rosuvastatin into the market--doctors should pause before prescribing this drug. Physicians must tell their patients the truth about rosuvastatin--that, compared with its competitors, rosuvastatin has an inferior evidence base supporting its safe use. AstraZeneca has pushed its marketing machine too hard and too fast. It is time for McKillop to desist from this unprincipled campaign.

And Astra-Zeneca responds: (warning, pdf file) The response.

The BBC news has this article on the subject: AstraZeneca defends its new bestseller

According to the magazine, AstraZeneca needs to eat into this market to recover from falling profits and flat sales of its ulcer pill Prilosec which is facing stiff competition from generic drugs.

When The Lancet's editorial was written, AstraZeneca's latest financial figures had been disappointing, its profits falling fast.

But on Thursday this week the drugs firm reported a reversal of its fortunes with a rise in pretax profits to $1.11bn, up from $923m during the same period earlier.

The recently launched Crestor was a major contributor to this rise, having already gained a 2% market share, and analysts expect the drug to bring in $3bn worth of sales a year.

I doubt that this story will surprise anyone. The pharmaceutical industry functions to make money for investors. Often this goal aligns with improving patient care. Sometimes the industry just looks for market share, and patient care effects are neutral. This controversy most likely reflects a drug with no major advantage for patients, but a major financial advantage for Astra-Zeneca. They have every right to market their drug. They should not complain too loudly when the are criticized. "The lady doth protest too much, methinks" - Shakespeare, Hamlet

Pfizer Wins FDA Approval of Inspra for Heart Failure

Pfizer Inc. on Wednesday said U.S. regulators approved the company's drug, Inspra (eplerenone tablets), for congestive heart failure patients who have already had a heart attack.

The U.S. Food and Drug Administration approved Inspra last year for treating high blood pressure.

Inspra, a selective aldosterone blocker, will compete with older classes of drugs such as ACE inhibitors and calcium channel blockers.

I have blogged extensively on eplerenone in the past - just do a search to find the articles.

Most physicians dislike direct to consumer (DTC) advertising. Apparently we are in the minority. F.D.A. Reviews Ads for Drugs

An ad for the prescription drug Zoloft asks: "Feeling sad? Anxious? Tired?" Zoloft is sold by Pfizer as a treatment for depression and other disorders. It is but one of many print and broadcast advertisements that pitch prescription drugs directly to consumers - a category of ads scrutinized last week at a hearing held by the Food and Drug Administration.

The two-day hearing, in Washington, was part of the agency's review of the rules governing prescription-drug advertising. Because many of the 29 studies presented at the hearing reported positive public results - like increased communication between patients and doctors - the prevailing prediction among supporters of the ads was that the drug agency would allow the ads to continue in much the same form as today.

"It's rare that you get such validation from a meeting like this," said Dick O'Brien, executive vice president and director for government affairs at the American Association of Advertising Agencies, a longtime advocate for the ads. "This is one where you feel all of a sudden like you're on the side of angels."

"My hope is that these two days were so positive that they may help to put this controversy to bed once and for all."

Balderdash! I agree more with the following quote.

But some critics showed no sign of backing off.

"This is a really unlevel playing field for consumers," said Larry D. Sasich, a research analyst at the health research group of Public Citizen, a consumer advocacy group. "You have an industry that maintains that a 30-second or 60-second television spot empowers consumers to make an informed decision about their drug therapy."

Instead, Mr. Sasich said, the spots play up the promise of the products, leaving consumers on their own to ferret out potential side effects or adverse reactions.

The Washington meeting did not adequately address such issues, said Barbara Mintzes, a post-doctoral fellow at the Center for Health Services and Policy Research at the University of British Columbia in Vancouver.

"The question is: Who was talking?" Ms. Mintzes said. "There were a few people presenting who were independent, but the large majority were either people from the industry or financed by them."

Anyone was welcome to present original research at the meeting, but an open door does nothing to ensure that all the relevent research is included, Ms. Mintzes said.

I remain skeptical of these ads. However, it does appear that they will remain for the near future.

For those who are not jiggy with the lingo, PPI stands for proton pump inhibitor. This drug class includes Prilosec, Prevacid, Aciphex and Nexium (apologies to foreign readers - these are the US trade names). Since their introduction in the 80s they have made large amounts of money for their respective drug companies. That will probably change very soon. Heartburn Drug Battle Likely

Cracks appeared yesterday in a pillar of drug industry profits with twin announcements that users of a huge-selling heartburn drug will soon have alternatives that will be cheaper and easier to buy. As a result, the biggest fight ever seen between managed-care companies and drug makers could soon begin.

In the first announcement, Novartis said it would soon start selling omeprazole, the generic version of Prilosec, even though a court has yet to approve the sale. The aggressive move could open Novartis to huge damages if a judge eventually ruled that its generic version infringed patents owned by AstraZeneca, which sells Prilosec. But it also means that consumers will soon save a bundle on the medicine. Prilosec currently sells for $116 for a month's supply on Drugstore.com. A lone generic version introduced in December sells for $100; with more generic entries, analysts said the price could drop to $11.

Then Procter & Gamble said yesterday that it would begin selling an over-the-counter version of Prilosec on Sept. 15, priced about 70 cents a pill, or $22 or so for a month's supply.

The two announcements would not be so important if Americans collectively did not eat so much late-night pizza. But the obesity epidemic and the eating habits that have contributed to it have led to an explosion in heartburn in the United States.

Prilosec and its cousins Nexium, Prevacid, Protonix and Aciphex ? collectively known as proton-pump inhibitors, or P.P.I.'s ? are now the biggest-selling drugs in the world, with $13 billion in United States sales last year, according to NDC Health, a health information company. Prilosec's $4.6 billion in sales last year brought at least twice the profit generated by every McDonald's, Wendy's, KFC, Taco Bell and Pizza Hut combined.

But every P.P.I. works almost identically, and there is little evidence that one is any better than another. So when prices of both generic and over-the-counter versions of Prilosec plunge, managed-care companies will try to persuade patients taking other pills to switch. Some will probably stop paying for other brands altogether.

For all P.P.I's, the average monthly out-of-pocket payment for people with insurance is already more than $30 ? which exceeds the expected price of a month's supply of over-the-counter Prilosec. And that average payment will probably increase.

Drug makers, on the other hand, will use their considerable marketing muscle to persuade doctors and patients that they should remain loyal to brand-name prescription pills no matter the price. In similar previous battles, drug makers have generally come out on top.

Several key points here. First, the drugs are not very expensive to make - otherwise the OTC price would be much higher. Second, we will see a marketing battle over PPIs, not an efficacy battle. The NY Times article correctly states that the drugs all work the same. One does need to adjust the dose to achieve equivalence, but omeprazole (Prilosec) works very well.

I expect this rant will receive many testimonials both pro and con. To understand the passion this subject develops check out this December 2002 rant and examine the number of comments - Generic omeprazole . The NY Times predicts that physicians will go generic in this situation.

"A P.P.I. is a P.P.I.; they're interchangeable," he said. Dr. Seidman predicted that generic and over-the-counter versions of Prilosec would greatly reduce the money his patients spend on other P.P.I. brands.

Dr. Mark A. Fendrick, editor of The American Journal of Managed Care, said other companies would follow WellPoint's lead. "This is going to be a real test of how well managed-care companies can fight against the marketing power of the branded pharmaceutical industry," Dr. Fendrick said.

I like these announcements. OTC Prilosec and generic omeprazole (with competition) will save patients and insurance companies money. The pharmaceutical companies deserve an appropriate return on their investment. They have received excessive return thus far and hopefully these announcements will bring those returns back in line for this drug class.

Biting The Hand That Fed Me

I, of course, consider myself immune to these blatant attempts at persuasion. Am I? I think so. I read serious medical journals and unbiased reviews of medications. I always try to prescribe based on hard evidence. I use effective generics. I want the best for my patients.

I also know that someday I'll have a patient with irritable-bowel syndrome tell me she's tried everything. I'll ask her if she's tried the drug-that-paid-for-my-dinner. If she says no, I'll consider saying something like, "There's this new drug. It's pretty expensive, and I know that your insurance doesn't cover it, but it might be worth a try."

Ka-ching!

So it's probably time for Doctor E to take the pledge once more. To swear that he won't take any more of these gifts. To promise to get his information about drugs only from objective, unbiased sources. "I'm sorry," I'll say to the next drug rep, "but I can't accept your invitation. I'm doing my part to keep drug costs down."

That's what I'll say -- but do you realize how much ahi carpaccio costs when you have to pay for it out of your own pocket?

Read the entire self confessional. Dr. E lays out the physician pharmaceutical industry relationship concisely. What about db? db will eat the lunch at noon conference. He will occasionally pick up a pen or a pad of paper. db has a $10 rule.

I have at least one drug rep who avoids me entirely. He represents Nexium. I explained to him why I thought his company was acting unethically. I refuse to sign for Nexium free samples in our resident's clinic. He does not bother me anymore.

I have thought about how to address this issue for the past 2 days. Fortunately, Medpundit did a great job and I can focus on another 'sticky wicket'. Medpundit (go to Friday, August 8th - bloggers link function is acting funny again!!).

The Medical Letter, an excellent, unbiased source of drug information, reviewed the subject last month and found the evidence wanting. According to The Letter, the FDC Reports cited a study that found among 1,134 children, ?emotional lability? occurred in 3.2% of users compared to 1.5% of nonusers. ?Emotional lability? was defined as ?crying, mood fluctuations, thoughts of suicide and attempted suicide.? There were no completed suicides in the group. That's an important distinction. It isn't uncommon for depressed people, especially teenagers, to make a consciously feeble attempt at suicide - such as taking a drug they think is harmless, like Tylenol. Their goal isn't to kill themselves, but to gain attention.

On the face of it, the current recommendation to avoid these drugs seems overly cautious. For one thing, compared to older anti-depressants, they are more effective and they are safer. In the old days, before SSRI?s, doctors always excercised caution with anti-depressants because the drugs themselves could be instruments of suicide. Patients would only be given a small amount of the drugs at a time, say a week or two, to avoid intentional overdoses. With the SSRI?s, that?s not a problem.

To read the NY Times article that stimulates this discussion - Debate Resumes on the Safety of Depression's Wonder Drugs. I agree with Medpundit on this issue. I have seen dramatically positive results in many patients. The side effect profile seems much milder than the older antidepressants. She also makes a wonderful point about the NY Times arrogance concerning primary care physicians. Just another reason to show disdain for that paper.

DIY Drug Development?

Well, there's nothing there that 30 whole hours of free consulting can't fix, I'm sure. And all the universities have to do, it seems, is raise the money for the really expensive stuff. Quite a deal. I wish these folks the best, but I can't help but think that they're going to be climbing a steep learning curve with ropes and pitons. DB's hopeful comment is "If this works, the straw man argument about investing in research may move towards moot." Well, as someone who's been getting beaten up for years by said straw man, let me add some comments of my own: If you know some chemistry, some biochemistry, some molecular biology or medicine, then the business of drug development looks pretty hard. Then when you try it out, you find that it's a lot harder than it looks.

Well you cannot really blame me for hoping. I do believe some companies work very hard at research. One can ask about what kinds of research, how much, and what change would one project if reimportation works. This question (and any answer) has too many hypotheticals to allow good decision making.

So I do understand the difficulty of drug development. However, I am not certain if our current economic situation is sustainable. Moving towards a free market (as the Cato authors suggest) may or may not change research investment.

I find Robert Prather one of the most compelling bloggers. Probably that stems from our very similar philosophy. I wrote to him, asking him to comment on yesterday's post concerning reimportation. Here is his post - Drug Reimportation And The Current Split Among Free-Marketeers. As I read his post, I believe that his main point stems from favoring a free market philosophy but not trusting other countries. His points are well made. I still believe that reimportation will move the market efficiently.

Maybe this is really the answer - Three Universities Join Researcher to Develop Drugs

But university officials say that system is breaking down as pharmaceutical companies and venture capitalists have become more averse to gambling on raw technology and more interested in drugs that have demonstrated at least some promise in a small clinical trial. That has left more promising ideas unable to pass through what some experts have called the "valley of death" between basic discovery and commercial development.

"We in the university are being deprived of a common way to develop technologies because we cannot form companies like we used to," said Joel B. Kirschbaum, director of the office of technology management at the University of California at San Francisco.

The universities say they do not plan to become drug companies. But by doing more of the basic work on drugs themselves ? like testing them for toxicity in animals ? they say they can then entice pharmaceutical companies. Moreover, they say, they will get a better deal because some of the risk has been taken out.

Whether the consortium will work is open to question. Under the deal, SRI International, which does contract research, will offer the universities up to 30 hours of free consulting for each project to develop a plan for how to test for toxicity, make the drug for clinical trials and other necessary steps. But the universities would still have to come up with the money for the tests, manufacturing or other tasks.

If this works, the straw man argument about investing in research may move towards moot.

Conservative Drug Split

The prescription-drug-reimportation bill the House passed in the wee hours last Friday morning, by a vote of 243 to 186, was widely opposed by the thoughtful Right ? folks at AEI, CEI, the Heritage Foundation, the Manhattan Institute, Americans for Tax Reform, the Club for Growth, the Wall Street Journal, the Washington Times, even Cato's own Doug Bandow in last Thursday's NRO. When we saw, however, that principled members of the House like Jeff Flake (R., Ariz.) and Pat Toomey (R., Penn.) were on the other side, we thought we'd take a closer look. It turns out that this really is one of those issues that's as simple as it seems ? free trade is the answer ? although it's easy to be distracted by the complications that surround it. And that, unfortunately, appears to be what's happened to many of our friends and colleagues.

Nuances in the bill aside, its effect would be to allow prescription drugs ? most of them developed and manufactured in America, but available far more cheaply abroad ? to be reimported into this country at those much lower prices. To be sure, many in Congress who supported the bill did so on crass political or anti-corporate grounds: drugs cost too much; drug companies are gouging the public, as is evidenced by prices abroad; let's drive domestic prices down, and cut government outlays in the process, by letting Americans buy from abroad. "The issue is price," said Rep. Rosa DeLauro (D., Conn.). "It is time that this Congress stop acting as a wholly owned subsidiary of the pharmaceutical companies and step up to its responsibility to the consumers of this nation." Motives aside, that's an easy target for those who understand FDA regulations on drug research and development; the extraordinary upfront costs of R&D; the need for drug patents to encourage R&D; and socialized national medical systems abroad.

Because our drug market, burdened as it is with regulations and cost controls, is still free relative to such systems, America's drug companies, which do most of the world's drug research and development, recoup most of their costs, including R&D costs, in the domestic market, then sell abroad at prices far below true costs. Foreigners are thus classic free riders. As with defense, Americans are underwriting a good part of the health-care costs of the rest of the world. But if we allow those below-true-cost drugs to be reimported, critics say, there goes the R&D and all the wonder drugs of recent years. As AEI's John Calfee put it in a July 14 piece aptly titled "The High Price of Cheap Drugs," "reimportation would mean importing foreign price controls, which would destroy the pricing structure of the U.S. drug market and have disastrous consequences for future drug research and development."

Those are powerful arguments ? until you stop to think about them, as Rep. Pat Toomey did in a July 17 "Dear Colleague" letter, one paragraph of which goes to the heart of the matter:

Specifically, dropping trade barriers and freeing U.S. consumers to purchase drugs at far lower prices overseas would significantly threaten the profit margins of the pharmaceutical companies. These companies would be forced to present the price-setting countries with an ultimatum: Either liberalize your market or we will leave. It's hard to imagine that countries in this situation will deny their citizens access to life-saving drugs. Instead, they will most likely ease their controls and increase the price they are willing to pay for their drugs.

Toomey goes on say that if free trade were not reason enough to support the bill before the House, then the destruction of price controls should be. In short, reimportation is both right and good.

These paragraphs just introduce a very careful and thorough analysis of this complex issue. As a libertarian, I agree with this essay. The authors (from the Cato institute) have worked through the pros and cons nicely. I believe that careful reading (which will take around 15 minutes) is worth your time. They conclude with this thoughtful paragraph.

In a nutshell, if foreign governments want to pay less ? and will not pay more even if it means their own citizens will go without better drugs ? then let those governments police the no-resell terms that enable them to get the lower prices. Right now, not only do Americans pay higher prices because foreigners refuse to pay the actual costs of drugs, but they pay the enforcement costs of that arrangement as well, including restrictions on their freedom. And if foreign governments cannot police those discriminatory contracts ? because the incentive to resell, on one side, and to buy more cheaply, on the other side, makes enforcement difficult or impossible ? then let a truly free market, encumbered only by enforceable contracts in restraint of trade, set prices at whatever the market will bear. It is neither right nor good that Americans bear so great a portion of the health-care costs of the world.

This article has tipped the balance. I am no longer confused over this issue. I clearly favor drug reimportation!

Drug Lobby Pushed Letter by Senators on Medicare

When the House voted last week to let Americans import less expensive medicines from Canada and Europe, 53 senators signed a letter opposing the legislation, a letter that the industry trade group, which vigorously opposed the measure, hailed as proof of its argument that the bill would jeopardize patient safety.

What the trade group, the Pharmaceutical Research and Manufacturers Association, did not say, at the time, was that it helped coordinate the signature campaign.

The Senate "Dear Colleague" letter, timed to coincide with passage of the House bill, will have an important role in whether the import measure survives a conference with the Senate on a larger drug benefits package. Several conferees, including Senators Orrin G. Hatch of Utah and Don Nickles of Oklahoma, both Republicans, are among the signers.

The trade group's involvement in gathering signatures, detailed in a document obtained by The Times, is not a surprise. It offers a glimpse into the aggressive efforts by the pharmaceutical manufacturers to defeat the import provision. That section would require the Food and Drug Administration to create a system for consumers, pharmacists and wholesalers to import less expensive drugs from Canada and Europe.

I need not comment - but maybe you will!

Lashing Back at Drug Companies

In addition, while the drug companies trot out the shibboleth that they need high prices to continue to fund high levels of research, the public is realizing that these companies spend a great deal on promotional and marketing activities -- including, presumably, the massive campaign contributions to Congress.

It's not difficult to understand why the public resents the drug companies when prices in the United States for critical medicines are often two, three or four times higher than the prices for the same medicines, made by the same companies, sold in Canada, Mexico and other countries.

We need them, but darn it could they just act a little more responsibly. (I know, they are acting responsible to their share holders).

A stellar commenter, RG, writes:

There is also a deeply held impression that these new drugs have revolutionized medical care in this country, as Doug Bandow seems to believe in his article. That may only be true to a certain extent.

In a compelling book, THE RISE AND FALL OF MODERN MEDICINE, Dr. James Le Fanu, a renowed medical writer from London, made the point that the fall of the pharmaceutical industry started around the late 1970s, when nothing new was added to our pharmocopeia in comparison to the drugs that were discovered and synthesized from after World War II to the end of the 1970s. And he is probably right.

There may have been a profusion of drugs over the last 25 years, but Dr. Le Fanu again pointed out that most of these were copy-cats from previously released drugs, costing much more and with at most marginal benefits. We can think of anti-inflammatories, antibiotics, hypertensive drugs, H2 acid antagonists, and a host of other me-too drugs that really have not made a dent in revolutionizing treatment. In short, he is suggesting Big Pharma had met a dead-end, a reason why it had to concentrate on life-style drugs (Viagra for impotence, Rogaine for baldness, the ill-fated phen-phen for weight loss) and forced many of the companies to merge into mega-giants to consolidate their dwindling new-product potential.

I beg to disagree. Having graduated from medical school in 1975, I would bring this perspective to argue the point. Let us start with heart failure. Back in 1975 we had no ACE inhibitors, or ARBs. The first study showing the CHF survival benefit of an ACE inhibitor was published in 1988.

The profusion of anticoagulants, helpful in treating acute coronary syndromes, which range from thrombolytics to platelet inhibitor drugs, have made signficant strides. We see more such drugs under development, enhancing our options to care for such patients.

In cardiac prevention, we have the statins - first represented by lovastatin. These drugs represent the only major class which clearly helps in secondary prevention and probably helps some patients in primary prevention.

Adult onset diabetes mellitus has several classes of hypoglycemics to draw on. We had first generation sulfonylureas.

AIDS is a new disease, and all the antivirals developed to treat AIDS have arrived over the past 15-20 years.

The proton pump inhibitors have revolutionized the treatment of acid disorders, and are not a me too drug when compared with H2 blockers. They represent the application of further physiologic understanding.

Since the 70s we have made remarkable progress in treating heart disease - and prolonging quality life! We have more specific cancer cures, especially with regards to lymphomas and leukemias. We have a greater assortment of antimicrobial agents, from newer antibiotics, to antifungals, to a variety of antivirals. We have a plethora of options for ameliorating mental illnesses (from depression to psychosis).

I do not accept Dr. Le Fanu's argument. While I have quibbles with the pharmaceutical industry, I cannot argue that they have done nothing worthwhile. Au contraire, they have provided me the tools to often modify the natural history of disease. Our profession (and here I speak principally of internal medicine as I am most familiar with internal medicine) is intellectually richer and more satisfying because of these and other pharmaceutical advances.

db descends from his soapbox. Back to pimping.

House Approves Bill Easing Imports of Less Expensive Drugs

In a major defeat for the pharmaceutical industry, the House voted by a wide margin early this morning to approve a measure that would make it easier for Americans to import inexpensive prescription medicines from Canada and Europe.

The vote, 243-186, came shortly before 3 a.m., after a fiery hour-long debate that capped a long and stressful day for lawmakers, who are rushing to finish their business by tonight so they can leave the Capitol to start their month-long summer recess.

The outcome was a surprise. Until the last minute, lawmakers on both sides were saying the vote would be too close to call. Even as the votes were being cast, some lawmakers held back, to see which way their colleagues were voting.

"I think this is the Congress saying, ?We hear you, drug prices are too high," said Representative Jo Ann H. Emerson, Republican of Missouri, who forced the vote by extracting a promise from the House leadership in exchange for favoring a broader Medicare prescription drug benefit that is a high priority of the White House. She added, "It's time we stopped subsidizing the world and bring fairness and fair prices to Americans."

The measure now becomes the official position of the House in its negotiations with the Senate to reconcile differences in their two versions of the prescription drug legislation. But its fate is uncertain; on Thursday, 53 senators released a letter saying they oppose the provision. And it is unclear how hard the House representatives in the Medicare negotiations will fight for it.

The Republican leadership of the House worked vigorously against the bill, as did the drug manufacturers--who stand to lose millions if it becomes law--and the Food and Drug Administration, whose officials argued the measure would jeopardize safety. The vote did not fall along party lines; rather, the debate turned on whether lawmakers were willing to accept the drug makers' argument that the measure would harm patients and defy free trade by allow the importation of not only drugs, but price controls.

"This is an interesting debate, because its not between the Democrats and the Republicans" said Representative Ted Strickland, Democrat of Ohio, who supported the measure. He added, "It's between the people and the pharmaceutical companies."

About this bill, I just do not know. Read my earlier post (scroll down, it is the 3rd post down from this one) on the pharmaceutical industry. I am confused.

Today's Lancet has an editorial which explicates the problem of how we should treat the pharmaceutical industry. What price competitiveness in the drugs industry? This article refers to a consideration of the issues which have made the United States the leader in new drug development. The article takes a European perspective, but it gives an excellent balance to our philosophical conundrum.

Since 1990, the US pharmaceutical industry has surged ahead of that in Europe. While spending on research and development in Europe increased 2·5-fold from 1990 to 2002, in the USA such spending jumped 5-fold. US firms are adopting and exploiting new technologies more rapidly and claiming more patents in important areas like biotechnology. Indeed, to take advantage of this American productivity, European-based drug companies are spending more and more of their research and development budgets in the USA.

In 2000, a panel of experts commissioned by the European Commission produced a report, Global Competitiveness in Pharmaceuticals, that concluded: "Europe is lagging behind [the USA] in its ability to generate, organise, and sustain innovative processes that are increasingly expensive and organisationally complex." The report identified several reasons why the US industry has pulled ahead. It found, for example, that American research is "an integrated system, highly differentiated and pluralistic within a common framework", while European science "is composed of fragmented and relatively small national systems". In fact, European scientists are more likely to collaborate with US researchers than with scientists in other European nations. The USA has also created a vertical system in which small innovative exploratory companies develop new products which can then be exploited by larger firms that have the staff, expertise, and capital to refine and market those products.

But a major factor behind the US success is money: drug prices are not fixed in the huge American market, whereas in Europe many countries control drug prices or place regulatory caps on profits. As a result, while drug prices in the USA have been rising steadily over the past several years, price increases have been kept down and several European governments have actually been initiating price cuts. As one drug industry official told the Wall Street Journal, "Companies go where they get the best return on their investment and right now that is the US".

And that defines the dilemma. We want to keep drug prices reasonable and affordable for the masses. Yet we also desire the advances that the pharmaceutical industry provides. Our challenge comes in striking the right balance of price and innovation.

Many of the Commission's recommendations are interesting, in particular the establishment of an NIH-like organisation to help bring European scientists together. The degree to which the market should be allowed to determine drug prices is more problematic. Any reform would need to take into the account the risk such changes will pose to the health systems of Europe, which have sought to provide affordable health care for all. The success of the American system has encouraged scientific advances but it has failed to give access to those advances to everyone who needs them.

So we are left to consider the greater good. Which do we prefer? Should we have rapid advances in pharmacotherapeutics? Or should we slow down advances so that everyone can afford their medications? We have no good answers to this dilemma.

In the US we are still considering the possibility of allowing importation of drugs from Canada and elsewhere. This certainly would help some patients financially, but will it effect innovation. I am stumped. The questions seem simple, but the answers evade me.

For another opinion on this issue - Demonizing Those Who Cure Us

The research group Europe Economics found that patients often wait years for access to even life-saving new medicines. Incredibly, the more useful the product and the more people to be helped, the smaller likelihood that European governments will quickly approve it. Explained Europe Economics: countries "facing tight budget constraints will be more resistant to a given price demanded by a company the higher they expect the demand for the product to be."

The rest of the article deals mostly with the importation issue. I continue to have mixed thoughts on these issues. I present these links so that you can share my confusion.

I just might be unbiased. I doubt it, but I have received criticism that I am pro pharmaceutical companies, and criticism that I am blindly anti pharmaceutical companies. That diversity of criticism makes one suspect that perhaps there is a quest for truth herein. Today you decide. Study Finds Drug Costs Are Soaring for Elderly

The study, which was issued yesterday by Families USA, a consumer group, shows "how important it is to offer significant subsidies to the lowest-income seniors," Ron Pollack, the group's executive director, said in a telephone interview.

As many as half of the elderly do not have insurance for drugs for some part of the year, he said, because they either lack coverage or have exceeded the limits on their policies, which frequently cap the amount the insurer must pay.

Prices for the 50 drugs increased an average of 6 percent, compared with a rise of 1.8 percent in the Consumer Price Index, excluding energy prices, the study said. More than half of the drugs increased by three or more times the inflation rate, while a quarter stayed the same.

Over the years, drug prices have consistently outpaced inflation, said Mr. Pollack, who noted that these increases are particularly hard on the elderly, who are often on fixed incomes.

An elderly person without coverage buying Lipitor, Vioxx, Synthroid and Fosamax would pay nearly $3,000 a year for all four drugs, Families USA said.

The study met with sharp criticism from the pharmaceutical industry, which argued that many elderly people were able to buy drugs at discounted prices. "Regrettably, Families USA has decided to continue complaining about prescription medicines, rather than to pitch in and help seniors get the medicines they need," the Pharmaceutical Research and Manufacturers of America, a trade association, said in a statement. "Instead of misleading seniors by referencing only undiscounted prices, it should be helping them gain access to the life-saving, cost-effective medicines they need."

Some economists read this site. They appropriately jump all over me when I beat up the pharmaceutical companies too much. Perhaps they can explain the hyperinflation of drug prices. Perhaps they cannot.

This commentary implies that anti-pharmaceutical industry organizations are having a negative impact on future development of HIV drugs. AIDS drug incentive dilemma

Dr. Des Martin, president of the South African HIV Clinicians Society, suspects that "among several reasons, the threat of generic competition and attacks on multinational companies could be behind the recent decline in HIV anti-retroviral compounds." Some drug company boardrooms are certainly switching investment from AIDS research into areas where they can still make profits, such as erectile dysfunction and baldness.

As drug prices have fallen more than 90 percent in poor countries, treatment of the afflicted has risen, but not by much. Why? Prices are a small factor in creating access to AIDS drugs. However, the price fixation of left-leaning health nongovernmental organizations (NGOs) has led them to concentrate on this issue at the expense of more important matters such as building health infrastructure and training medical personnel. While the Bush team commendably plans to spend money on these essential components, it seems to be unaware of the long-term harm of the anti-pharma campaigns. It may even compound the problem as it announced that the Bush program will purchase generics from Indian producers.

I need more data here. We do need a balance between greed and enough profit to incentivize research. How do we balance the drug company's interests and the interests of poor countries with overwhelming numbers of AIDS patients.

We need incentives for HIV drug research. Pharmaceutical companies, like all companies, exist first to make a profit for the owners. They will apportion their resources in those areas where they expect the highest probability of return on investment.

Thus, we have a dilemma. We can easily ponder the questions and conjecture hypothetical answers. In the meantime the international AIDS epidemic is not decreasing.

A terrible mistake

It is a bill that will bar the Food and Drug Administration, which was expressly created to guarantee the safety of drugs, from stopping drugs from coming in from Canada and 25 other countries, including South Africa, where more than 20 percent of its drugs are counterfeit or adulterated, even if it thinks it might undermine the safety or security of the supply of medicines in America. Imagine that: Congress telling the FDA to take a powder when it comes to the basic mission of ensuring that the medicines we take are safe.

This bill is at odds with a letter Mark McClellan, the FDA's commissioner, recently wrote saying that he couldn't guarantee safety, and neither could his Canadian counterparts. But Mrs. Emerson and her GOP colleague, Gil Gutknecht of Minnesota, are so determined to import Canadian-style price controls that they ignore Mr. McClellan's warnings. In the FDA's place, Mr. Gutknecht would require that packaging of every prescription drug incorporate "overt optically variable counterfeit-resistant technologies," whatever that means.

I always find Robert Goldberg's opinions interesting and thought provoking. This commentary addresses the problem of importing pharmaceuticals.

While I agree with some of his points, as usual I cannot agree with all his points. I do agree that the FDA should have jurisdiction regarding this situation. Patients are at risk from imported drugs. Quality control should concern everyone.

I disagree with him on the problem of financially impacting the pharmaceutical industry. If we could insure quality concerns, I would favor the competition. The pharmaceutical industry could (and should) live within a true market economy. He opines:

Drug companies and biotech firms alike would be forced to sell their products at generic drug margins and at the lower value of the Canadian dollar, devastating investment in a generation of smarter drugs and personalized medicine. Mrs. Emerson and Mr. Gutknecht blather on about how their bills promote "free trade," but if they really did, they wouldn't stop at drugs. They would allow for the reimportation of automobiles, which, if just limited to the top selling 50 models, would save Americans $11 billion a year. Why not just turn Canada into one big Costco, for that matter?

I find this paragraph hyperbolic. Why should the US (and only the US) fund pharmaceutical research? How much profit margin does the pharmaceutical industry need? I doubt that competition would prevent ongoing research.

Are the pharmaceutical firms selling drugs at less than cost to other countries? Again I find this unlikely. I suspect that the pharmaceutical industry would still make money and still make research.

F.D.A. Approves Over-Counter Sales of Top Ulcer Drug

Prilosec is expected to sell for less than $1 a pill when it becomes available without a prescription this fall, compared with $4 a pill now. But few consumers who have health insurance will see any savings, because many managed care plans will stop paying for the drug altogether, health care executives said.

"We don't cover over-the-counter drugs," said Deborah Whitehead of Tufts Health Plan, a major insurer in the Boston area.

But older people of limited means who have no health insurance other than Medicare, which does not cover prescription drugs, stand to save hundreds of dollars a year.

Patients who take similar drugs, like Nexium, Prevacid, Protonix and Aciphex, may soon find that their health insurers have made the medications more expensive or harder to obtain, managed care executives said. That would parallel what has happened since Claritin, the widely used allergy drug, was switched to over-the-counter from prescription sales late last year.

Millions more Americans will be affected this time. Prilosec and similar drugs, known as proton-pump inhibitors, had $13 billion in total sales last year, more than any other class of drug and more than twice that of Claritin and similar antihistamines, according to NDCHealth, a health information company. Unlike allergy drugs, whose effects vary somewhat, the proton-pump inhibitors all have nearly identical effects on patients. That may give health plans a freer hand to force patients to use over-the-counter Prilosec rather than the prescription versions.

So paradoxically, a cheaper drug might cost you more! This ruling makes sense for the nation. This ruling makes sense for patients who pay for their own medications. But it will cost some patients money.

Senate Votes to Give Consumers Faster Access to Generic Drugs

The Senate overwhelmingly approved a proposal today to give consumers swifter access to low-cost copies of brand-name prescription drugs.

It also turned back a Democratic effort to limit the premiums that could be charged for new prescription drug benefits under Medicare.

The 94-to-1 vote on generic drugs came just minutes after the 56-to-39 vote on Medicare premiums.

Both proposals were offered as amendments to a sweeping bill that would add drug benefits to Medicare and fundamentally restructure the program, which provides health insurance to 40 million people who are elderly or disabled.

We will have a Medicare drug bill. The political forces that favor this bill are too strong to stop a bill.

Will we have the right bill? Probably not, but one can argue that this imperfect bill will improve patient health. Back to the generic issue:

House Republican leaders have shown little interest in such generic drug legislation. But Mr. Schumer said it would be difficult for them to kill the proposal in the expected conference committee to iron out differences on the overall Medicare bill.

Mr. Schumer said the generic drug proposal could save consumers $60 billion to $70 billion in the next decade and could reduce Medicare costs by $18 billion to $20 billion. The proposal goes beyond new rules issued last week by the Food and Drug Administration, which took its own action to make generic drugs more accessible. In recent years, Mr. Schumer said, brand-name drug companies have used "frivolous patents, lawsuits and legal mumbo-jumbo" to delay the marketing of generic drugs.

The Gregg-Schumer proposal would limit the ability of brand-name drug companies to delay federal approval of competing generic drugs. Brand-name manufacturers would be allowed only a single 30-month stay, while a court tries to resolve patent disputes. Brand-name companies have sometimes blocked competition for much longer, by filing additional patent claims and piling 30-month stays on top of one another.

The measure would also bar collusive agreements under which brand-name drug companies pay generic companies to keep generic drugs off the market.

The existing law provides an incentive for generic drug companies to challenge patents that may be invalid. If they are successful, such companies have the exclusive right to market the generic drug for 180 days, but sometimes the drug never reaches the market. Under the Gregg-Schumer proposal, generic drug companies would have to market the drug in a timely way or lose their 180-day protection.

This bill should fix a system that has meandered from original intent. We want the pharmaceutical industry to have sufficient incentives to produce new drugs. They deserve some patent protection. Where I (and many physicians) object is the legal games that the industry plays to extend patent protection beyond the time the law allows. This drug should close some legal loopholes. Patients will benefit.

Bush Announces an Easing of Rules on New Generic Drugs

President Bush announced new rules today that make it easier to introduce lower-cost generic versions of prescription drugs, intensifying his efforts to address health care issues ahead of next year's election.

The president, making good on a proposal he first made last year, said the Food and Drug Administration's action would limit the ability of pharmaceutical companies to delay the introduction of generic versions of prescription medicines. He said the F.D.A. rule would curtail a practice among manufacturers of brand-name drugs of delaying the introduction of generic versions by filing multiple patent-infringement lawsuits against potential competitors.

Under current rules, each patent-infringement suit causes a 30-month delay by the F.D.A. in considering generic versions of a drug for approval. Mr. Bush said drug makers would now be limited to a single 30-month regulatory delay to sort out patent disputes.

Mr. Bush said he was also directing the agency not to block generics because of patent disputes over minor issues like the color of a pill bottle or the use of ingredients not related to the drug's effectiveness. And he said his action would tighten the overall rules on patent applications, making it a criminal offense to make false statements to get a patent.

"By taking these actions, we will bring generic drugs to the market much more quickly ? in some cases, years earlier," Mr. Bush said during an appearance at a hospital here. "And this should save the American consumers about $3.5 billion a year, savings that will go, of course, to the consumers, to our seniors, or to Medicare programs administered by the state or to employer health plans."

The trade association for the big pharmaceutical companies signaled that they opposed the administration's decision and would fight similar legislation pending in the Senate.

Physicians generally favor using generics. Not all patients agree. Just do a search on generic omeprazole and you can read about the many readers who believe that this generic drug does not work.

I certainly favor more access to generics. While drug costs continue to rise even for generics, they do tend to stimulate market forces and lower prices for the class involved.

Over-the-Counter Rx

ADDRESSING THE HIGH COST of prescription drugs is an important and complicated national problem, but one relatively simple fix could provide a measure of relief: making sure such drugs truly require a doctor's prescription and letting those that don't be sold over the counter. The matter of a drug's status is up to the Food and Drug Administration, but the agency has historically taken a reactive approach, reviewing whether a medicine should be moved from prescription-only to over-the-counter availability only when drug companies asked for a switch and provided the necessary proof. As a practical matter, that has often meant that drug companies waited until patents were about to expire -- exposing them to price competition from generic versions -- and then asked to go over the counter, reaping the dual benefits of brand-name identification and a bigger potential market. But with drug costs escalating, insurers who bear the extra costs for many Americans have begun to press the FDA to act on its own.

The first such switch, launched at the behest of WellPoint Health Networks, a California insurer, occurred in time for the allergy season this spring, with the country's most popular allergy drug, Claritin, being made available over the counter. The maker of Claritin, Schering-Plough, grudgingly acceded to the change in status, and the price of Claritin has dropped from $3 a pill to $1 -- with generics and store brands available for even less. The FDA may soon move for the first time to force a switch for two similar antihistamines, Allegra and Zyrtec. An FDA advisory panel concluded the medications could safely be sold without prescriptions, as they have been in other countries for years, but the industry is resisting, and a legal battle is likely. Possibilities for other switches include the ulcer and heartburn drug Nexium, arthritis and anti-inflammatory drugs such as Celebrex and Vioxx, and perhaps even the morning-after birth control pill. With the advent of more effective home testing and monitoring devices, the possible universe of candidates for over-the-counter status could expand further.

The Washington Post argues in favor of these switches. I have mixed feelings. Some of the drugs mentioned could either hide more serious disease, or cause signficant complications. However, decreasing drug costs is a worthwhile goal. Balancing my fears with the financial realities leaves me generally in favor of allowing more drug classes to go OTC.

A loyal reader and fellow blogger - Alex Chernavsky - suggests this link - Drug firms profit from 'murky' link with journals, study shows. He is right to make the suggestion.

The "murky" relationships between the world's leading pharmaceutical companies, supposedly independent medical journals and family doctors are exposed in the British Medical Journal today.

A landmark edition of the BMJ is devoted entirely to claims that patients and governments are being systematically misled over the benefits of new treatments and therapies by drugs giants. It is the most comprehensive and damaging dissection to date on the tactics used to promote new drug products, despite supposedly strict guidelines safeguarding the independence of research and a ban on advertising medicines in Britain.

One of the BMJ studies exposes the first weak link in the chain from a company developing a drug to it becoming an international "bestseller". It outlines how pharmaceutical companies increasingly sponsor research into therapies and treatments previously funded by governments. Scientists from York University in Canada found that published clinical studies sponsored by pharmaceutical companies were four times more likely to favour products made by that company. The drugs in question ranged from contraceptives to treatments for depression, osteoarthritis and Alzheimer's disease. In some supposedly independent academic studies, the drug produced by the sponsoring company was compared with an "inappropriate" alternative, or was given at a higher dose, meaning it was bound to be more effective, the BMJ claims.

The next step for the drugs giants is to get their new products approved by govern-ments. Experts for the BMJ analysed the way in which five antidepressant drugs were submitted to the Swedish authorities for marketing approval. As well as submitting "favourable" trials sponsored by the drugs companies themselves, the journal found that some studies were being submitted twice, or even three times, but in different publications so that the pile of evidence looked weightier. "Selective" submissions meant trials that did not strongly support the drugs were left out.

Richard Smith, the editor of the BMJ, analysed the influence drug giants had on the medical newspapers - their shop window for prescribing doctors. Many publications rely heavily on revenue from advertisements placed by the very drugs companies they should be scrutinising - adverts Mr Smith says are often "misleading". Moreover, some companies may offer to buy advertising space on the basis that the paper runs articles favourable to their products.

"Health care, doctors, journals and, I believe, the pharmaceutical industry, would all benefit from relationships being less grubby and kept more at arm's length," Mr Smith concludes.

Yet another study cited by the BMJ found that GPs who regularly spoke to sales representatives from drug companies were more likely to prescribe medicines unnecessarily and in contravention of guidelines. Mr Smith said: "The [drug] industry dominates health care, and most doctors have been wined and dined by it."

But perhaps most worrying is the way that drug companies in Britain now give money to patients' groups - or even set up their own ones - in an effort to promote products directly to the public. Unlike in the US, there is a strict ban in Britain on marketing prescription medicines directly to the public. But patient groups are now relying on drug companies for up to 20 per cent of their funding, says a BMJ article.

Lest any readers have forgotten, I personally use the $10 rule. I will accept lunch at a conference, or a pen, or a pad of paper - as long as the value is $10 or less. I will not attend any dinner meetings, go to any plays or even play golf on pharmaceutical industry money. Our division will not allow any pharmaceutical sponsored talks at our weekly noon conference - even if it would help us financially.

This case, like most whistle blower cases, will become nasty. Court Papers Suggest Scale of Drug's Use

Documents released yesterday in the case of a drug company whistle-blower shed light on how extensively doctors were involved in promoting unapproved uses of a Warner-Lambert drug, Neurontin.

Warner-Lambert paid dozens of doctors tens of thousands of dollars each to speak to other physicians about how Neurontin, an epilepsy drug, could be prescribed for more than a dozen other medical uses that had not been approved by the Food and Drug Administration. The top speaker for Neurontin, Dr. B. J. Wilder, a former professor of neurology at the University of Florida, received more than $300,000 for speeches given from 1994 to 1997, according to a court filing. Six other doctors, including some from top medical schools, received more than $100,000 each.

Other doctors were paid to write reports on how Neurontin worked for a handful of their patients, the court papers said. Still others were paid to prescribe Neurontin in doses far exceeding the approved levels as part of a clinical trial that Warner-Lambert created to market the medicine, according to the court papers, which are new documents filed in the lawsuit by the whistle-blower. The papers are backed up by hundreds of pages of corporate documents and memos recently filed with the court.

The whistle-blower, Dr. David P. Franklin, a former Warner-Lambert employee, contends that the company's marketing tactics, which have helped make Neurontin a top-selling medicine, with more than $2 billion in revenue, were illegal. He says that federal and state governments paid hundreds of millions of dollars for Neurontin as doctors prescribed the drug to Medicaid patients for various conditions including pain, bipolar disorder and restless-leg syndrome.

It is illegal for a drug company to market a medicine for uses the F.D.A. has not approved, but doctors can prescribe a drug in any manner that they think is best for their patients.

Lawyers for Dr. Franklin argued that the company relied on the doctors to market Neurontin for unapproved uses because it was illegal for the company to do so. The speaking program, which also included paying doctors to listen to the speeches at hotels and resorts, was called peer selling, according to the documents.

I have several comments on this story. First, these allegations do not surprise me. I know many academic physicians (and practicing physicians) who markedly supplement their income speaking for pharmaceutical companies. I have personally been approaced and made the decision to forgo that lucrative income stream. This was a personal ethical decision. Many physicians rationalize that the company does not control their content. I do understand that rationalization, but do find it a rationalization.

Second, I do favor off label use of Neurontin. I never go to drug company sponsored dinners or meetings (I went to a few 15 years ago, prior to considering my personal ethical framework for interacting with the pharmaceutical industry). I assume that the information that colleagues have given me on off label Neurontin use came from these apparently illegal practices. Thus, I have a quandry. I do believe that off label Neurontin works - especially for certain types of pain syndromes. However, I am concerned about how we obtained that knowledge.

This case leaves me with shades of grey. The company seems to have broken laws and profitted greatly. However, they may have given physicians a valuable tool for treating some patients.

They could have, and should have, sponsored formal research into these areas, with a goal of obtaining FDA indications. They did not, and if found guilty should receive an appropriate penalty.

Check my pulse, this rant defends the pharmaceutical industry! Seriously, the pharmaceutical industry has contributed greatly to our improved health - both quality and quantity of life. But the trial lawyers see more deep pockets. Watch out for some costly suits. Trial Lawyers Now Take Aim at Drug Makers

Enriched and emboldened after successful fights against asbestos and tobacco companies, some of the nation's top plaintiffs' lawyers have trained their sights on drug makers, claiming that many giant pharmaceutical companies have hidden the dangers of medicines the lawyers say have harmed thousands of people.

In some cases the drugs at issue have already been pulled off the market, like Rezulin, a diabetes treatment from Pfizer that the Food and Drug Administration has linked to liver damage and is the target of almost 9,000 suits. Other suits name some of the industry's current best sellers, including Paxil, an antidepressant that plaintiffs contend is addictive — a claim denied by the drug's maker, GlaxoSmithKline.

In some instances, teams of plaintiffs' lawyers are spending several million dollars preparing cases for trial, in the hopes of winning billions of dollars in settlements and jury verdicts from the drug companies, which have some of the deepest pockets among American corporations.

The lawyers pursuing the suits say that the Food and Drug Administration has systemically failed to protect patients from dangerous drugs, and that the companies have tried to hide side effects. But the agency says medicines are safer now than they have ever been.

Depressed? Go see a trial lawyer. Pregnant? Call a trial lawyer.

The trial lawyers have no controls. They never seem to consider the public welfare. They see dollars, deep pockets, and potential victimization.

Why do I rail against the trial lawyers? They bother me for several reasons. First, they always appear sanctimonius. They are only suing to protect the "little people".

Second, I understand the contingency fees for which they work. They want large settlements, partly because they keep a large percentage.

Third, their suits undermine the fabric of our society. That seems a bit harsh on first reading, however, I believe that their accumulated suits (and incessant advertizing) have contributed towards our become a society of victims. Their attitude, and more important their actions, make us believe that we should never have adverse outcomes, else we can blame someone and sue them .

If they succeed with these law suits, then future patients will suffer. But they do not seem to care. They see targets for suits. They vision money trees. They never seem to understand the consequences of their "victories". And our society is damaged with each verdict.

First Biotech Drug to Treat Asthma Clears Key Panel

An advisory panel of the Food and Drug Administration yesterday endorsed Genentech's new asthma drug, the first biotechnology product for the disease.

The advisory panel, meeting in Gaithersburg, Md., voted 11 to 0 that the benefits of the drug, known as Xolair, outweigh its risks. The vote is expected to pave the way for the F.D.A. to approve the drug next month. Genentech, which is based in South San Francisco, Calif., developed Xolair with Novartis, the Swiss pharmaceuticals company, and Tanox Inc., a biotechnology company in Houston.

"I think that's as good as the company can hope for," Joel Sendek, an analyst at Lazard, said of the panel's vote.

Still, the panel members, who are mainly medical professors and practicing physicians, had some concerns about the safety of the drug and its effectiveness in certain patients, including those over 65. The agency's staff, in its own review of the data, said that the drug's effect was modest.

The biggest safety concern is that the drug might increase the risk of cancer. The rate of cancer in the group treated with Xolair in clinical trials was 0.5 percent, more than twice the 0.2 percent in the group that received a placebo.

Panel members said this evidence was inconclusive because of the small number of patients who developed cancer. Also, some members said, cancers usually take years to develop, making it unlikely that the drug caused the cases that arose during the yearlong clinical trials.

My quick summary - we have a new asthma drug which should receive approval. Now we need to understand its mechanism, and likely use.

Xolair is a monoclonal antibody, a type of genetically engineered protein, which would make it the first protein drug to be approved for asthma. It is taken by injection once or twice a month. The antibody blocks the action of immunoglobulin E, a substance in the body that helps set off allergy and asthma attacks. While many drugs try to blunt an attack once it begins, Xolair is designed to prevent such attacks from starting at all.

In clinical trials, those who took the drug had a lower number of asthma attacks than those who received a placebo. More of the treated patients were also able to reduce or eliminate their use of inhaled corticosteriods, which can have long-term side effects. One person who took the drug in clinical trials told the panel that he was able to join a softball team for the first time.

Genentech, Novartis and Tanox originally applied in 2000 for permission to sell Xolair to treat both asthma and hay fever in both adults and children. But the next year, the F.D.A. requested more safety data. The companies then decided to apply only for asthma use and only in adults and adolescents.

This drug does not represent a panacea. However, it will add another option for some patients. As usual it will take some time to understand how it works in routine practice. I am somewhat wary, but do find this an interesting possibility.

Claritin's Price Falls, but Drug Costs More. What a dilemma! For those with drug benefits, the switch from prescription status to lower cost over the counter access for Claritin means that those patients pay more out of pocket for the same drug.

This is the first spring in which Claritin, the most popular allergy drug, is available without a prescription. A major health insurer pushed for the change, arguing that it would benefit consumers. But instead, insurers ? and the employers that pay for health insurance themselves ? have so far been the biggest beneficiaries, paying for allergy drugs a fraction of the $1 billion or more that Claritin used to cost them each year.

As an over-the-counter drug, the price of Claritin has fallen by one-half or more, to about $1 a pill. But because consumers now pay the full price themselves, a month's supply costs them roughly $30, instead of the $15 to $20 co-payments that people with health insurance used to pay.

This example highlights the paradoxes of both the health insurance and pharmaceutical industries. Health insurers desperately are working to control health care costs. Thus, getting a drug class to go generic saves them significant moneys. The pharmaceutical industry wants prescription drugs, as they can then charge (and receive) more money.

Each industry is entitled to some profit. However, patient welfare rarely enters their decision making. While I do understand capitalism, and the benefits therein, one can argue that these industries should take some social responsibility also.

The cost shifts may ultimately prove to be temporary, particularly if many new nonprescription drugs face the kind of generic competition now surfacing for Claritin and drug makers adjust prices to reflect the medicines' mass market status. Already, Claritin's over-the-counter status and lower price is benefiting consumers without prescription drug coverage. But even so, the overall current cost to consumers is substantial, since Claritin and the other drugs in question are among the top-selling prescription medicines.

Dr. Mark McClellan, the F.D.A. commissioner, said in an interview that there were legal and practical complications to iron out and he intended "no imminent action" on the status of any more major drugs. He noted, however, that an agency advisory panel of experts had recommended the switch for all three top allergy medicines. They are considered far safer than some allergy drugs already sold without prescriptions, which have been blamed in road accidents involving drivers who fell asleep.

"When the science and cost issues match up, it's definitely something the agency should consider very seriously," he said.

This has made the pharmaceutical industry very nervous.

The drug makers and insurers have many billions of dollars at stake in the debate over switching the status of prescription drugs. Thanks in part to aggressive marketing, Claritin, Allegra and Zyrtec have been some of the top-selling prescription medicines, generating at least $7 billion in sales for their manufacturers in 2002.

Even more important for the makers, if the F.D.A. forces Aventis and Pfizer to change the availability of Allegra and Zyrtec, it could set a precedent for other drugs.

A nonprescription version of Prilosec, a $4 billion ulcer treatment made by AstraZeneca, is expected to be approved by the F.D.A. this summer after preliminary endorsements by an agency advisory panel. Prilosec has already lost its patent protection, so its contribution to AstraZeneca's profits is declining. But if the agency were to force AstraZeneca's patented successor drug, Nexium, to be available over the counter, the company's profit ? and perhaps stock prices of the industry as a whole ? could be affected.

This switch to a potentially activist FDA certainly provides an interesting possibility for investors to consider.

Recently I praised Thomas Scully for his courage in standing up to the pharmaceutical industry. This editorial in the Washington Times disagrees - Medicare reform, French style

 The biggest obstacle to President Bush's plan to improve Medicare is the guy who runs the program right now. In his State of the Union address, the president said that no bureaucrat, trial attorney or HMO should make medical decision, that only doctors and patients should do so. Yet, Tom Scully, the director of the Center for Medicare and Medicaid Services (CMS) can't wait to extend the rationing and price controls, which now apply to doctors, hospitals, medical devices and some medicines, to every prescription drug.

Mr. Scully said in a recent New York Times article: "We fix prices for every physician procedure and hospital visit. It would be much better to have private health plans make these decisions, but I try to be the best price fixer I can be."

Maybe Mr. Scully should work for the Chirac administration. For, rather than finding important ways to move Medicare into the marketplace, he is adopting the French method of cost containment called reference pricing. Mr. Scully calls it "functional equivalence." The government first haggles over the cost of every new drug and then either pegs the price at the generic or lowest-priced version of a product that treats the same disease, whether they are similar or not in terms of how they work, their effectiveness or impact on total cost or well-being. Patients or hospitals have to pay the difference between the price of the new drug and the government-set reference price. Drugs without an approved price receive no reimbursement at all.

Indeed, Mr. Scully claims that these drugs are mirror images of each other, so why pay more, particularly when you can spend the money on other services. But as Columbia University Business School economist Frank Lichtenberg has shown, the more money you spend on new drugs, ?$4 for every $1 of new drug spending to be exact ? the more you save on those physician procedures and hospital visits Mr. Scully loves to price-fix.

Well, Mr. Goldberg (the editorialist) knows a lot about politics and perhaps even economics, but he does not know medicine. He continues this harangue with a spirited defense of Nexium and Aranesp. I admire his hyperbole and obfuscation, but he clearly is writing as a shill for the pharmaceutical industry.

I include this link in the spirit of balance. This blog always tries to present both sides of the issue. I do get the last word - afterall it is my blog!

My earlier rant continued -

The Bush administration told drug companies today that many of the techniques they use to sell their drugs run a high risk of violating federal fraud and abuse laws.

The warning came as the government issued a compliance guide for the drug industry, telling manufacturers that they must not offer any financial incentives to doctors, hospitals, insurers or pharmacists to encourage or reward the prescribing of particular drugs.

Such payments have "a high potential for fraud and abuse," said the guide, issued by Janet Rehnquist, inspector general of the Department of Health and Human Services.

Federal law prohibits payments intended to generate business under Medicare or Medicaid, the federal health programs for 80 million older, disabled or poor people.

The law, known as the antikickback statute, forbids some practices that are common in other industries, Ms. Rehnquist said.

She said she was particularly concerned about marketing practices that drive up federal costs, interfere with clinical decision making and lead to overuse or inappropriate use of drugs.

These practices do not surprise physicians. This article just adds fuel to my fire over the marketing prescription drugs.

Ms. Rehnquist also warned drug companies that their research and education grants must be divorced from their marketing, or they risk violating the law.

If a drug company has any influence over the content of a professional education program or the choice of speakers, "there is a risk that the program may be used for inappropriate marketing purposes," the compliance guide says.

It also says that when drug companies pay doctors to conduct research, they must make sure the research is legitimate, "not simply a pretext to generate prescriptions of a drug."

Research and education grants are suspect if they are "based in any way, expressly or implicitly," on a doctor's ability to generate business for a drug maker, the guide says.

These represent two practices that we see too often. First, drug companies enroll physicians in "research" studies. These studies are not legitimate, but rather marketing tools. They allow the companies to invite physicians to "research meetings" - generally at fancy resorts. They also get physicians "used" to using their product - with the intent of a carryover phenomenon to "non-study" patients.

The educational programs are similar. They invite physicians to fancy dinners, or golf outings, or shows, for the ostensible purpose of an educational program. These programs always concern a disease for which they have a drug, or about to have a drug. Thus, they "educate" us in a way that is advantageous to their product (sometimes blatantly, sometimes insidiously).

These practices represent another factor in my disgust over their marketing techniques. Apparently, this pro-business administration agrees with me!

Off site seeing this morning - read this article, then come back later - I will have a long commentary on this article (and probably some additional blogging). U.S. Warns Drug Makers on Illegal Sales Practices

Still on the road - now in Vancouver for the week, first vacation then the SGIM meeting. Later this week I will comment on the SGIM report on the domain of general internal medicine. Fortunately, this wonderful hotel has high speed internet access, so that I can browse and blog daily. My blogging will be a bit limited secondary to the small keyboard on my laptop, and my schedule.

Earlier this week I started focusing on the pharmaceutical industry. Today, I will share an excellent NY Times article, and use it to expand on points I have previously made. The expansion is necessary because of questions and comments from readers.

Talking Up a Drug for This (and That) discusses "off-label" drug use. For those who are unfamiliar with off-label drug use:

Actimmune's sales represent an extreme case of what is known as off-label use. Doctors are allowed to prescribe a drug for unapproved uses, but drug companies cannot promote such uses, though in some cases they can provide educational material to doctors.

But drawing the line is tricky, and regulations are in flux. The Food and Drug Administration says restrictions on off-label marketing may conflict with the right to free speech, and it is considering relaxing the rules.

Some other drugs are sold mainly for nonapproved uses. Provigil, a drug from Cephalon that increases alertness, is approved only for narcolepsy, but most of its nearly $200 million in sales last year were for sleepiness linked to other conditions. More than 90 percent of the $119 million in sales of thalidomide, from Celgene, were for cancer, not for its approved use, leprosy. Most of the $2.3 billion in sales of Neurontin, from Pfizer, are for uses other than epilepsy, for which it is approved.

THROUGH off-label use, doctors can start treatment without waiting years for a new approval. Patients, particularly those with life-threatening diseases, often clamor for such drugs. But critics say the system allows companies to circumvent scientifically valid but costly trials.

Cephalon and Celgene have received reprimands from the F.D.A., and Pfizer has been sued over the issue. InterMune has never been warned by the F.D.A.; the company's backers say this shows that it is playing by the rules. Executives of the company say it is only responding to demand.

"We don't market it" for pulmonary fibrosis, said W. Scott Harkonen, InterMune's chief executive, in an interview. "There's been a lot of interest in the medical community, and we've responded to those requests."

But there is evidence that the company has actively stirred interest. At an investors' conference in September, it said its sales force included 60 pulmonary specialists to call on every lung doctor in the country ? "all in the context of our education and awareness program," a company executive said. Its annual report for 2002 said profits on Actimmune were low because of royalties and "direct costs of marketing."

InterMune has sponsored dinners at which doctors hear speeches by pulmonary fibrosis experts, who mention Actimmune. It has set up booths at pulmonology medical meetings. It financed the creation of a nonprofit patient advocacy group called the Coalition for Pulmonary Fibrosis.

"They are using the education loophole in a way that becomes advertising and promotion," said Michael Rosenzweig, president of the Pulmonary Fibrosis Foundation, an advocacy group based in Chicago.

As I read Robert Prather's argument (see yesterday's rant, and read his rant also), we should have no such thing as "off-label". Pharmaceutical companies need only prove that a drug is safe. Once safety is assured, then we physicians could sort out efficacy. But how can we sort out efficacy, if we have no requirement for companies to fund efficacy trials?

I am not alone in wanting an efficacy agency, funded by a special tax on pharmaceutical sales. Such an agency could supply the data that I need to better care for patients. One could argue that the studies required for FDA approval do not adequately explore efficacy and additional indications.

So we are stuck in a quandry. How much information do I need to make medication decisions? Certainly, I do not want to prescribe unsafe drugs, but most drugs are unsafe at some dose or in some people. Prior to spending health care dollars on medications, I hope to believe that there is a return on that investment. I should not prescribe a $4/day drug unless I have good evidence that I will be helping you.

So the real question focuses on how physicians can have the data that they need to work with patients to make good treatment decisions. The corollary question relates to how do we insure good data. Which studies contain data which help us?

This article discusses the "off-label" use of a drug for a progressive and fatal lung disease.

The big trial, involving 330 patients, ended last year and was intended to see whether the drug improved lung function. But the lungs of those who took Actimmune were not significantly better than the lungs of patients who received a placebo.

Somewhat unexpectedly, however, patients who took Actimmune often lived longer. That result was not statistically significant over all. But in a subset of patients with milder disease, there was a large and statistically significant difference: only six who got the drug died, compared with 21 who got a placebo.

Are these data adequate to spend $50,000/year. And who should spend the money - insurance companies (including Medicare) or patients themselves? We have a challenging problem here. I still believe that a properly funded FDA could and would help us with the decision making process. They would solve the unbiased scientist problem.

I worry about the chaos of a no efficacy rule. I worry about the impact on our medical knowledge. Having a no efficacy rule would further muddy pharmaceutical claims. The pharmaceutical industries best interest probably will not align with my patient's best interest.

Many patients will swear by a drug - based on anecdotal evidence. Others will swear at a drug - based on anecdotal evidence (for a great example of this, read my rant on generic omeprazole and the many comments). We need unbiased, composite data. Patients deserve the results of well done trials to inform their medical care. Our current system, while not perfect, does insure that we do get data, at least on the initial indication for the drug.

Robert Prather has a very interesting piece today - Even More Radical Change Needed At The FDA

In addition to moving more drugs to the over-the-counter market the FDA's mandate should be limited to safety only, rather than efficacy. Let the doctor decide which drug is most effective and most appropriate. That's what they are paid for. The FDA should focus on safety only.

We have two interesting concepts here. The first refers to an article in today's Washington Post. FDA Says It Can Take Away Drugs' Prescription Status

The Food and Drug Administration has concluded that it can force drugmakers to switch some of their prescription drugs to over-the-counter medications as a way to make them cheaper and more easily available to consumers, senior FDA officials said yesterday.

The prospect of forced switches is strongly opposed by drugmakers, who say that the policy could result in the unsafe use of some drugs. But the momentum toward requiring drug companies to make certain products available over the counter appears to be growing, and two popular prescription allergy medications -- Allegra and Zyrtec -- will likely be the test cases if the FDA decides to go forward.

Now this is an interesting concept. I believe that for many drugs, physicians will support this concept strongly. I certainly would expect that the FDA would get input from physicians concerning the potential risks of OTC status. Some drugs should remain prescription only. We will have to follow this story to see what decisions the FDA makes. I would give this concept a tentative thumbs up.

On the other issue though I disagree with Prather's suggestion. I do believe that medical care benefits from the FDA's requirement of efficacy prior to approval. Let me lay out my reasoning.

The argument against proof of efficacy is that physicians can review the data and make their own decisions. I have spent 3 days now ranting about how physicians are often incompletely influenced concerning prescription drugs.

If we had no proof of efficacy requirement, then we probably would have fewer good studies of efficacy. The FDA requirement forces the pharmaceutical industry to perform important efficacy studies . If we had no efficacy requirement, drug companies would have the ability to assert claims without supporting data. The evidence based physician would not have the data necessary to make good decisions about drugs.

Thus, Prather proposes a theoretically sound alternative (the safety only plan), which would harm medical care indirectly. I assert that the unintended consequences of such a rule would hamper overall medical care.

I am sitting in a hotel room (fortunately the have hi-speed internet access). On Wednesday I started down a road and have not yet reached the end. Therefore, I will continue discussing this issue at least today. I encourage readers to read through the thoughtful comments on yesterday's rant. I will excerpt some comments and address some comments.

And I can't really play the outraged innocent, because I have been wined, dined and entertained at the expense of the industry many a time. That would actually make for a great rant. Do you accept such invitations, and what is your opinion of doctors who do?

I personally have the $10 rule. I do eat drug company sponsored lunch at conferences that I am attending anyway. I will eat a brownie, cookie or banana. I will accept a pen or a paper pad.

I will not go to dinner, play golf, or go on a trip sponsored by a pharmaceutical company. Should physicians do those things? Many physicians delude themselves, thinking that accepting such gifts does not influence them. I have previously ranted about this issue - Gifts . Each physician should consider his/her ethical framework concerning this issue.

I would find this a more compelling argument if doctors thought that people outside the medical field ought to decide what is and is not a legitimate means for increasing their income. For example, it's very clear to me that my doctors, trying to maintain their income in this era of low-HMO payments, are interested in moving me in and out of their office in the absolute bare minimum of time. To that end, they treated my asthma by shoving some inhalers at me and telling me to call in in six weeks. They were visibly irritated when I phoned them about non-threatening bouts of asthma -- you would think a doctor might appreciate that not being able to breathe even a little bit is kind of frightening. Did this risk my life? Nope. But it certainly reduced the quality of care I got, as they had neither the time nor, apparently, the knowlege of the advances in asthma treatment, to improve my outcomes. I'm not talking about one doctor, either -- I'm talking about a succession of GP's who have bequeathed to me permanent scarring in my bronchia due to their perfunctory treatment. I have a pulmonologist now, but for the rest of my life I'm going to have to struggle to breathe because no one took ten minutes to explain the long term progress of the disease, and the need for steroid treatment, to me when it counted.

This is a poignant comment. I do like the debating technique, when one cannot really defend the pharmaceutical industry, one can reply by attacking physicians. I will try to break this comment down and respond directly.

As I (and other medical bloggers) have pointed out repeatedly, current physician reimbursement methods have negative implications for patient care. Physicians respond to financial considerations. We work under a bizarre reimbursement scheme - one which financially penalizes us when we take more time to see a patient. We work on a flat rate per case reimbursement. No lawyer, accountant, plumber, car repair mechanic, etc would consider such a bizarre system.

So what's the point? To resolve the above comment, we need to reconsider how physicians are reimbursed. Our current system is economically unsound. The incentives are malaligned. I hope to blog more on this issue over the next week.

What you don?t seem to like is that their best case for their drug is seldom the whole truth. That?s marketing for you. And a messy, sordid business it is, compared to science. Yet the information alternative to marketing in the practice world is likely to be ignorance rather than science?except for the few docs in fulltime practice who read their journals regularly. Pharmaceutical marketing, for all its one-sidedness, may even be socially useful if it leads to patients getting drugs that they need and would not otherwise get, provided that the benefits of the drugs are worth the cost. That outcome, of course, depends on we physicians acting as informed consumers and evaluating what drug reps tell us critically?as, I believe, most of us do. That?s how a marketplace is supposed to work. What would you suggest instead?

I love hyperbole! The lack of drug reps would not lead to ignorance. The reader does point out an important point. The best defense against the pharmaceutical industry's incomplete truths is stronger continuing education. Continuing education is very problematic. As the Associate Dean of CME, we are investigating methods for delivering information to physicians. The standard lecture method is not very satisfactory. We must learn how to provide useful information - both "fair and balanced".

I hope this discussion will continue for a few days. Send email, make comments, let me know your thoughts - both positive and negative.

My post yesterday on the pharmaceutical industry struck a nerve in at least one reader. You can read his comments, my response to his first comment, and then another reader's response. I expect more comments on that post.

Last night, and this morning I have considered the original comment, my post, and my response. Rather than my usual browsing the web today, I will just reflect on the pharmaceutical industry. I expect and hope for vigorous commentary on this rant.

Why should we admire the pharmaceutical industry? This industry has done much to improve medical care, decrease mortality and improve quality of life. As I reflect over the past 30 years of medicine (I was a 3rd year student in 1973), the number of new drug classes is astonishing. This list is likely incomplete - beta blockers, calcium channel antagonists, ACE inhibitors, ARBs, statins, fluoroquinolones, H2 blockers, PPIs, SSRIs, glitazones, antivirals (working against influenza, HIV, hepatitis C, the herpes family), interferons, many cancer drugs, TNF alpha antagonists, etc. Stop reading for a few seconds and reflect on that list. When I was a medical student, we treated hypertension with alphamethyldopa and a thiazide. We had very few other options. We had no known treatment to decrease CHF mortality. The treatment for ulcer disease was surgery. We knew cholesterol was a risk factor, but had no good agents to decrease cholesterol. We had no antiviral therapies.

I could ramble on for some time. The pharmaceutical industry has delivered wonderful advances which do make a major difference in our medical care. We have an expanding therapeutic armamentarium to choose from. These advances come, in part, because capitalism rewards helpful innovation. I salute the pharmaceutical industry.

For every yin there is a yang. Good is often balanced by evil. Darth Vader started out pure - then he surrendered to the dark side.

The pharmaceutical industry has heroes. The basic research provides wonderful advances. The industry invests heavily in research.

The problem begins when the marketing and promotion departments get involved. This is the face of the pharmaceutical industry to physicians. This face often looks evil to many physicians.

Let me try a few examples. Every drug company makes an ACE inhibitor (allow me some hyperbole here). Each ACE inhibitor is better than the rest (just ask the pharmaceutical rep for that particular ACE inhibitor). This story is easily repeated for many drug classes.

Now I took Logic in college. I understand that the reps are using sophistry and obfuscation. They only do this, because their superiors teach them. No political campaign has as well considered "talking points" and "spin doctors" as does a new drug campaign.

I accept that they are trying to put their drug in a positive light. But they lie! And their lies cost patients money.

Read about Nexium. Why I've lost respect for the pharmaceutical industry .

The federal official in charge of Medicare and Medicaid told doctors last month that they should not prescribe Nexium, a new heartburn drug, saying it was identical to an older drug, Prilosec, which became available in a cheaper generic form in December. The admonition infuriated executives of AstraZeneca, the maker of Nexium and Prilosec, who contend the new drug is superior.

That quote comes from another recent rant - Money talks .

So my problem with the pharmaceutical industry is not with the back rooms. The research and the product are commendable. The business tactics are often reprehensible.

So I will continue to have a love/hate view of this industry. We need a strong industry; we need their continued investment in research; but we would like higher ethical principles in marketing and promotion. I remain schizophrenic on this subject.

As Oliver Hardy (of Laurel and Hardy) often said, "Here's another nice mess you've got me into". While I rant often about the evil pharmaceutical companies, could they actually be agents for good? Drug Makers Expand Their Medicaid Role

A growing number of pharmaceutical companies are offering to take on prominent public health roles in helping to care for the sickest poor patients in some states.

Under the agreements, the drug companies create guidelines for treating Medicaid patients with chronic conditions like asthma and diabetes. The companies then pay for case workers to help patients follow the guidelines ? for example, by phoning them to remind them of the importance of taking their medicine regularly and eating properly. The case workers also talk to the patients' doctors so that care focuses on managing disease rather than treating an acute event like an asthma attack.

The drug companies say the programs save taxpayers millions of dollars by keeping Medicaid patients out of the hospital. But critics of the programs say the drug companies are sponsoring them to persuade state governments to drop efforts to demand lower drug prices. The critics say there is no proof that the programs save money, and that states could save far more by demanding lower prices from the pharmaceutical companies.

We have an interesting conundrum. If a drug company provides a worthwhile service to patients, and also benefits (in terms of market share), how do we reconcile our ethical position.

By offering the disease management programs, Pfizer got all its products included on Florida's list, which has quickly paid off. Since the program started in June 2001, Pfizer has been getting a greater share of the more than $1.5 billion that Florida spends on Medicaid drugs each year. Last year, the state's Medicaid program bought $122.4 million of Pfizer products ? a 22.6 percent increase, according to state figures, versus a 14.5 percent increase in Florida's Medicaid drug spending over all.

There, your honor, is the evidence of Pfizer's nefarious plan. Their plan is working, they are evil.

Bob Sharpe, director of Florida's Medicaid program, said he was already negotiating with the drug makers to extend the programs for another year. Mr. Sharpe said he believed that Pfizer would be able to show that it saved the state $15 million in the first year as the company promised to do. Pfizer and state officials plan to release a report on those savings in coming weeks.

"These programs not only yield savings but they are an investment in people," Mr. Sharpe said. "This is something that will save us money year after year."

Many patients have lost weight, begun exercising or changed their diets, he said, since Pfizer's program began. The programs are not designed as drug marketing programs, he said, and do not recommend specific brands of medicine.

Oops, this does not sound so bad. They, Pfizer, have a disease management program that does not just rely on medications. The disease management program has a $15 million guarantee for the state - money saved primarily through decreased hospitalizations.

About 13,000 Florida Medicaid patients who suffer from asthma, diabetes, hypertension or heart failure are participating in Pfizer's program. The company reviewed past Medicaid claims to identify patients who were at the highest risk of being hospitalized. A network of 60 case workers, who are attached to local hospitals, contacted those patients, urging them to join the program. The case workers then regularly talk to participants about how to better manage their condition.

Larry J. Brown, a 44-year-old Gainesville resident who suffers from diabetes, said he had lost about 80 pounds since beginning Pfizer's program last year. "They'll make sure you get your medicine on time and everything," he said. "I feel a thousand times better."

Now I am really confused. Could the drug company program really help patients?

But some who have studied the programs are skeptical.

In a review of Florida's program by the Henry J. Kaiser Family Foundation, analysts noted that the drug company programs created a potential conflict of interest.

"If a competitor's product is proven to be more effective than that of the manufacturer running the disease management program, will patients receive the most effective product if it drives market share away from the disease management sponsor's product?" the report asked.

And Dr. Thomas Bodenheimer, a professor at the University of California at San Francisco, said the drug makers had so far not been able to prove that their programs saved money. The companies have been offering the programs, mostly to health insurers, since the mid-1990's.

Dr. Bodenheimer said that some well-designed disease management programs offered by other sponsors had been shown to save money, especially for patients with congestive heart failure or asthma. But so far, he said, the drug companies have not been able to prove their savings by doing a statistically valid analysis.

"It is like money down a rat hole," he said.

Wow! How do we judge these programs? Many of us tend to attribute only evil intentions to pharmaceutical companies. Our first instinct is to look for their edge.

All business situations do have the possibility of Win-Win solutions. Could these disease management programs provide such solutions? Should I trust the pharmaceutical industry? Should I trust state government assessments (especially when the pharmaceutical industry contributes to the governor's election campaign)? Should I trust the critics, many of whom criticize almost by reflex (assuming the the pharmaceutical industry cannot do good)?

I need more information here. This report makes me think. I may need to reconsider my paradigm. Are you reconsidering yours?

So how are we going to pay for those expensive drugs? One interesting way is to use the therapeutic maximum allowable cost. In this plan, you get the low cost alternative or you pay for the high cost alternative. Benefits Cap May Help Treat Drug Costs.

Eager to tame the rising price of employee health benefits, U.S. companies are taking a closer look at how some European countries manage prescription drug costs.

It's an approach known as ``therapeutic MAC,'' for maximum allowable cost, which caps the amount health insurers pay for specific groups of prescription medications.

...

Potential savings depends on how the benefit is designed, where the cap is set and the rebates and refunds drug companies pass onto the health plan.

Take the cholesterol fighting drugs known as statins.

According to calculations by Jack Holton, and analyst with human resources consultant Towers Perrin, prices on these drugs run from $110 for a 30-day supply of Merck & Co.'s Zocor to as low as $31 for a generic.

A common three-tier drug plan charges employees $10 a month for a generic drug. Copayments for name-brand prescription drugs are $20 or $40, depending on whether the drug is categorized as ``preferred'' or ``non-preferred.''

Zocor, which is a ``preferred'' name-brand drug under the formularies for several health insurers, would cost employees $20 a month, leaving the employer to pay the remaining $90. The copayment for a prescription of Pfizer Inc.'s Lipitor, which costs less than Zocor, is $40 a month because the drug is ``non-preferred.''

Under a benefit plan designed by Holton that uses reference pricing and a 20 percent copayment a $31 generic drug would cost an employee $6 for a 30-day supply, Zocor would cost $57, Bristol-Myers Squibb Co.'s Pravachol would cost $27 and Lipitor $15. The employer's portion of all three drugs is $53.

``It puts in direct alignment the cost of the drug and what people pay,'' Holton said. ``Under the current system, just because something is a preferred name-brand drug does not mean it is the lower costing drug.''

This approach actually makes a lot of sense. It would encourage the pharmaceutical industry to compete on price rather on marketting. This would encourage real capitalism.

For a very interesting insite into the pharmaceutical industry - please read an outstanding comment that I received - The Pharmaceutical Industry Fights Back. The comment author, a former pharmaceutical rep, outlines the real world of pharmaceutical marketing. I greatly appreciate her candor.

I love ranting against Nexium. My housestaff know this is a pet peave. I am not alone!!! Medicare Head Tells Doctors Not to Prescribe Nexium

Thomas Scully, who heads the federal Centers for Medicare and Medicaid Services tore into the company over the purple pill, suggesting to doctors at an American Medical Association conference that the company was using the drug to rip off consumers and the government.

"You should be embarrassed if you prescribe Nexium, because you're screwing your patients and you're screwing the taxpayers," Scully said.

AstraZeneca gained Food and Drug Administration approval for Nexium (esomeprazole) in February, 2001. The new drug was widely seen as an important new revenue stream after a similar AstraZeneca ulcer drug, Prilosec, lost its patent exclusivity.

Scully, who was integral in formulating the Bush Administration's plan to finance a prescription drug benefit for Medicare beneficiaries, accused the company of "coming up with games" that keep patients paying for new, high-priced drugs.

Bravo!! Bravo!!!

Well said - When TV Commercials Play the Doctor.

Since the Food and Drug Administration relaxed its rules governing advertising of prescription drugs five years ago, I've seen a steady increase in the number of patients asking for certain expensive new medicines. Often these patients don't really know the purpose of these drugs or their risks or side effects ? they've just seen a nice ad on TV or in a magazine. While I've usually found that I can convince patients that they don't need these drugs (if they're inappropriate), it can be very hard to persuade patients to try pain relievers other than Vioxx and Celebrex, since often patients in pain are looking for anything that will help, and these drugs are effective and well known.

A recent report by the General Accounting Office estimates that every year at least 8.5 million Americans request and obtain specific prescriptions after seeing or hearing ads for particular drugs. In 2001 drug companies spent about $2.7 billion on such advertising, a 150 percent increase since 1997, when the F.D.A. loosened its rules on advertising. This is still less than the amount drug companies spent promoting their drugs to doctors (and I'll admit, I've listened to their talks and eaten their sandwiches). But most doctors, unlike patients, make their decisions based on clinical experience, and at least where I work, doctors usually greet these drug promotions with a dose of skepticism.

Perhaps the most unsettling finding of the accounting office report is that many of the prescription drug ads are misleading and are seen by millions before the government even considers stopping them. The F.D.A. is not required to review the ads before they hit the airwaves. Often, by the time the agency sends out letters telling companies to stop a particular ad, it has already run for months and been taken off the air.

...

Medicines aren't like shampoo or perfume. They're things people need to maintain health, not discretionary products a person can use or throw away on a whim. I'm all for educating patients so they can make informed decisions about treatment. But these ads aren't educational tools, they're sales pitches ? and as hard as we doctors try, it's tough to compete with the likes of Patti LaBelle and Dorothy Hamill.

As Drug Patents End, Costs for Generics Surge

Prices of generic drugs are rising almost twice as rapidly as prices of brand-name drugs, even as many insurers and the Bush administration are pressing Americans to switch in the name of saving money.

The trend is expected to continue over the next few years as a number of enormously popular brand-name drugs lose their patent protection and drug makers introduce generic versions at high initial prices.

This is a disturbing trend which will have a major impact on the cost of health care. Perhaps this trend will stabilize over time.

Drug Makers Battle Plan to Curb Rewards for Doctors.

Drug companies and doctors are fighting a Bush administration plan to restrict gifts and other rewards that pharmaceutical manufacturers give doctors and insurers to encourage the prescribing of particular drugs.

In October, the Department of Health and Human Services said many gifts and gratuities were suspect because they looked like illegal kickbacks. Since then, a few consumer groups, including AARP, have voiced support for the restrictions. But they are outnumbered by the drug makers, doctors and health maintenance organizations that have flooded the government with letters criticizing the proposal.

If this subject interests you, please read the entire article. This article speaks to the dependence of many educational programs on the pharmaceutical industry - including most medical societies. The managed care industry and the pharmaceutical industry also have a major relationship, with incentives to the insurers for using a high percentage of a particular pharmaceutical.

I understand all of the problems, and hope that the government has the courage to tell all to bite the bullet and accept the new rules. They can adjust, and should.

Drug classes are not always filled with equivalent drugs. The first ACE inhibitor - captopril - has a shorter half life than the rest of the available class, and thus is more difficult to use. One could find many such examples of the first being the least useful. However, when it comes to proton pump inhibitors, it appears that they all work similarly. That is why the release of generic omeprazole (Prilosec) is so exciting. And physicians are responding predictably and prescribing the generic! Generic Drug Prilosec Off to Strong Start in U.S.

Today's Wall Street Journal has a column titled - Doctors Aren't Immune To Pitches by Drug Firms. If you can either get your hands on the print version or subscribe to the online version, I recommend reading the entire article. I have written previously about the dangers of getting our information on new drugs from the industry which profits by selling those drugs.

Doctors underestimate their susceptibility to the sales pitches and perks offered by drug companies, and that isn't good for patients.

The latest twist in the continuing debate focuses on promotion posing as continuing medical education. (Related article) Most physicians say they can separate selling from science, and many believe marketing is a black art that sways only lesser mortals.

Yet a growing body of academic research shows that doctors are vulnerable to drug-company influence. Add the increasing volume and sophistication of industry promotion to that predisposition, and the result should have patients wondering whether a ghost writer is at work behind their doctor's prescription pad.

"Doctors are like anybody else who is influenced and generally would deny it," observes Robert Goodman, an internist at Columbia Presbyterian Medical Center in New York and a medical school teacher.

Doctors are "smart, tend to be a little bit arrogant, and are very naive about business," explains Dr. Goodman, who founded a group called nofreelunch.org to persuade doctors to renounce drug-industry influence on their practices, teaching and research. The "more you think you're immune, the more you're willing to partake."

Most drug reps avoid me, as I am argumentative and often obnoxious when approached. When they have a good product I do praise them. I personally will not accept anything valued over $10 (yes I will eat the lunch or the cookies). I get most of my drug information from the Medical Letter and the Prescriber's Newsletter. I pay for those services and believe them unbiased.

We should not fool ourselves. The drug reps are buying influence and we should not be selling out.

Claritin price to drop by as much as 76%: Allergy drug to be available over the counter this week. Hmmmmmmmmmmppppppphhhhhhhhhhhh! How can that happen? And you know they are still making a LOT of money on the product!

PHARMACISTS IN New York and New Jersey said they plan to sell the basic version of the drug for between 92 cents and $1.17 a tablet, depending on the number of pills in a package, down from as much as $3.80 a pill in its prescription form. The exact price could vary by region and from store to store.

Last month the Food and Drug Administration cleared five formulations of the drug for over-the-counter sale, including Claritin-D tablets, which also contain a decongestant. Claritin-D will sell for a little more than basic Claritin.

This is still an expensive drug, but not as outrageously expensive as it was. This dramatic price drop show us the insanity of current pharmaceutical pricing.

What is DTC? Direct to consumer! Misled About Medicine: Government Report Says Some Drug Companies Use Deceptive Ads. We know this. What does Viagra have to do with dancing?

Last year, pharmaceutical companies spent more than $2.7 billion on advertising aimed at consumers, and the report shows that it was money well spent since patients requested and received prescriptions based upon their viewing of a specific ad.

The government says that ads with deceptive images — such as an ad for the arthritis drug Celebrex that depicts an elderly woman rowing a boat and riding a scooter — often exaggerate the benefits patients can expect from a medication.

In sum, the government report indicated that since 1997, the Food and Drug Administration has issued 88 letters to drug companies complaining of advertising violations.

"The violations have to do with companies overstating the benefits of their drugs, failing to adequately tell people about the risks and not balancing the good news with the bad news about the drug," said Dr. Sidney Wolfe of Public Citizen Health Research.

These ads give patients incorrect impressions about disease and treatments. They can negatively impact the doctor patient relationship and use valuable time to discuss the requested drug which is not indicated. I doubt that one can find many physicians who would endorse this practice.

A reader sends this rant:

I enjoy your blog site...I recently read of your disgust with Astra Zeneca and the Nexium patent extention nonsense. I agree.

On the bright side, as an example of a firm doing "the right thing," I wanted to call your attention to what Wyeth has done with their PPI, Protonix and Protonix IV. When this drug was launched two years ago, the average price to a hospital for any of the current PPI's (Prevacid, Prilosec, Aciphex) was about 3.00. Wyeth chose to offer BOTH Protonix PO and Protonix IV to hospitals at nominal pricing. As a result, this product is availiable to hospitals who choose to adopt a minimum 60% market share of Protonix at current pricing of:

.16 tablet 40 mg. PO
4.00 dose, 40 mg. IV

Each of these prices are BELOW Wyeth's cost. As an interesting sidenote, this is probably the first time a pharma company has launched a first to market, unique to class drug such as Protonix IV BELOW COST! The end result consists of hospitals saving many thousands per year in this drug class.

Well stated and accurate. I will repeat - JUST SAY NO TO NEXIUM. AVOID THE NEW PURPLE PILL!

FDA Approves 1st Drug to Build New Bone

The first drug designed to stimulate the growth of new bone won Food and Drug Administration approval Tuesday for treatment of osteoporosis, the brittle-bone disease that affects 10 million Americans.

The new drug, known as teriparatide, works by increasing the action of osteoblasts, the body's bone-building cells. This causes bones to become denser and more resistant to fractures, officials said.

FDA officials said the drug, given by injection daily, will carry a special warning because in laboratory tests teriparatide caused cancerous bone tumors in rats. The tumors, however, have not been seen in 2,000 people who tested the drug in clinical trials, officials said.

Teriparatide will be marketed by Eli Lilly and Company of Indianapolis under the brand name Forteo.

"We feel this is an important drug," said Dr. Eric Colman, a team leader in the FDA division of metabolic and endocrine drug products. "It is the first approved that stimulates bone formation instead of slowing the breakdown of bone."

I have not previously read about this drug. Being the cautious sort, I will wait until I learn more. Hopefully I can learn from either the Medical Letter or the Prescriber's Newsletter. If I find more information I will try to write about it here.

Decline in New Drugs Raises Concerns: FDA Approvals Are Lowest in a Decade

New drugs to treat and cure sick patients are coming into the market in the United States at the slowest rate in a decade, despite billions invested by pharmaceutical companies on research and a costly expansion by the federal agency that reviews new medicines.

The decline in the number of new drugs is most pronounced in the category considered by the Food and Drug Administration to have the greatest promise for patients -- those listed as breakthrough "priority" drugs and "new molecular entities" that are different from any others on the market.

The slowdown is troubling to many because it is largely unexpected. The drug industry now invests three times as much money in research as it did a decade ago, and the FDA has already undergone a major revamping to become more efficient and prompt -- an expansion funded largely by user fees from the drug makers. Yet the number of industry applications for innovative new drugs is down significantly, and the average time needed by the FDA to review applications is moving up.

The net result of both trends is a steep drop in the number of new drugs coming to the market to help cure and treat illnesses, and growing disappointment among many patients and their families and advocates.

"We hear talk all the time from the drug makers of the great drugs waiting in line, but the reality doesn't seem to match the facts," said Ellen Stovall, director of the Cancer Leadership Council, a patients advocacy group. "There's been a lot of hope about new drug cures and treatments and we've seen some progress, but lots more disappointment."

The possible reasons for the decline -- whether it is a function of FDA caution after some high-profile drug withdrawals, industry shortcomings and strategies, or a troublesome combination of both -- is the subject of an increasingly urgent debate. Some believe the drop is a relatively short-term development that will resolve on its own, while others believe there is a deeper and more fundamental problem.

"Industry was trying to hit home runs, and it struck out a lot," Henry McKinnell, chief executive of the largest pharmaceutical company, Pfizer Inc., said in an interview. "Added to that, the [FDA] is giving greater scrutiny to each drug application. The result is that we are spending more time on each drug, spending much more on research, but seeing a definite drop in the number of new drugs."

Perhaps much of the pharmaceutical industries intensity in legal tricks to keep drugs on patent stems from the lack of replacments in the pipeline. We should continue to watch this issue as it does portend the state of medical care in the next 25 years.

I have previously written about the battle against generic Prilosec (omeprazole). AstraZeneca has 'pulled out all stops' to prevent this release. Today's Wall Street Journal (available on the web only for money) has an article on this issue, from which I will quote.

The three drug makers -- Andrx Corp., Genpharm Inc. and Kudco -- have been in negotiations since a ruling on Oct. 11 by a federal judge that knockoff Prilosec pills made by Andrx and Genpharm both infringe on ancillary patents owned by AstraZeneca PLC, the maker of Prilosec.

However, Judge Barbara Jones, of U.S. District Court for the Southern District of New York, ruled that Kudco's pill didn't infringe on the patents. Kudco successfully argued that it coats omeprazole -- the generic version of Prilosec -- with a nonalkaline substance, and that it has its own patent on this method, valid until 2016.

That court win alone, though, wasn't enough to clear the way for Kudco to begin selling the prescription drug. Kudco, a subsidiary of Schwarz Pharma AG of Germany, couldn't launch first, because under a federal rule to encourage generic competition, Andrx and Genpharm had previously won exclusive rights to be first on the market with a generic Prilosec, which lost its main patent protection in October 2001.

Andrx and Genpharm are appealing Judge Jones's ruling. But in the meantime, they are pressing ahead in the consortium with Kudco. Had they not decided to team up with Kudco, the two other generics makers could have delayed a generic launch by months or years.

...

Prilosec was once the biggest-selling drug in the world, with $6 billion in annual sales. Sales slumped somewhat in the past year to $5.7 billion, making it the world's third-biggest seller behind cholesterol pills Lipitor and Zocor, made respectively by Pfizer Inc. and Merck & Co.

Prilosec costs nearly $4 a pill. A generic version of the drug will probably cost $3.50 in the first six months, but the price is expected to drop to below $2 within a year of launch.

Prilosec has been at the center of the debate over legal and regulatory moves by some major drug makers to delay generic competition against big sellers. AstraZeneca's original patent protection on the purple pill ended a year ago, but the company sought additional protection from generic competition.

This story (and the entire story is worthwhile of you have access to the newspaper) highlights my disgust with the pharmaceutical industry. I understand that they deserve a profit and patent protection. However, their legal manipulations to extend that protection are disingenuous and harmful to patients. Hopefully, we will have generic omeprazole soon.

Corporations Just the Tonic Drug Benefit Effort Needed.

Georgia-Pacific was contacted by a top executive of Eli Lilly, who told the paper company to withdraw from a coalition of big corporations pressing Congress to help reduce drug prices. Georgia-Pacific complied, believing it would lose a lucrative paper contract with Lilly if it did not. Marriott Corp. also withdrew, saying it had been warned by another drug company that if it did not, drug industry conferences would be moved to another hotel chain.

President Bush's action last week to speed up the availability of lower-priced generic drugs was widely seen as an effort to help Republican candidates running in areas with high concentrations of seniors. But it also was a victory for those corporations that challenged the pharmaceutical industry and refused to be intimidated.

Under the banner of Business for Affordable Medicine, about a dozen big companies, including General Motors, had pressed Congress to limit litigation by drug manufacturers that has slowed the introduction of lower-priced generic drugs to the market. Although Congress failed to pass it, the Bush administration took a similar step by executive order that could save employers and insurers an estimated $3-billion a year.

Scott Ingham, spokesman for Business for Affordable Medicine, said the companies are pleased their complaints prompted the president to act.

"We were able to bring together a number of well-respected drug purchasers who had a good story to tell," Ingham said. "Our coalition will continue to look at cost-containment strategies both at the federal and state level."

The president's action is seen by many experts as a possible turning point in a war where every previous political battle had been won by the pharmaceutical industry.

Get ready for Zetia (ezetimibe), the first in a new class of cholesterol-lowering agents that inhibits the intestinal absorption of cholesterol. FDA Approves New Cholesterol Drug and FDA Approves ZETIA, ezetimibe, for Cholesterol Reduction.

There are about 13 million patients taking statins, the most common class of drug used to treat cholesterol. Approximately, 60 percent of those patients don't reach their desired cholesterol level. When Zetia is added to patients' regimen, studies showed 72 percent of patients reached their goal.

On average, Zetia added to an ongoing statin treatment provided a 25 percent additional reduction in cholesterol, compared with a 4 percent reduction for placebo. Zetia can be taken alone, but only reduces cholesterol by about 18 percent, while statins alone lower it by about 40 percent.

...

The fundamental question is whether adding Zetia is clinically and economically better than just increasing the dose of the statin, which doesn't increase the cost but can increase side effects.

The wholesale cost for a 30-day supply of Zetia is $57.90. That will be on top of the statin's cost. Merck's statin, Zocor, has a wholesale price of $105.81 for a 30-day supply regardless of the dose.

Executives from the MerckSchering-Plough Pharmaceuticals LLC joint venture said doubling the dose of a statin will only reduce cholesterol by 6 percent. But Bernstein Research analyst Richard Evans said that 6 percent reduction will be enough to get 75 percent of patients who haven't met their goal to achieve it.

This drug will provide us an interesting adjunct to statin therapy. I do not expect lthat we will place large numbers of patients on this new drug, but it probably will be a worthwhile addition, since it does represent a different mechanism.

Ending a Drug Patent Scam

Goaded into action by election-year politics, President Bush took steps yesterday to close legal loopholes that have allowed manufacturers of brand-name drugs to keep cheaper generic versions off the market through devious delaying tactics. It was a modest step, but one that most people involved in the acrimonious debates over prescription drug prices will be able to support — except, of course, the pharmaceutical companies that have profited from the loophole.

I was talking to a frequent reader the other day. He pointed out my Democrat bashing (on trial lawyers and malpractice reform). I pointed out that I was equally harsh on the Republicans on the pharmaceutical industry and HMOs. This article eases my criticism of the Republicans a bit. Plan to Seek Faster Release of Generics

President Bush is to announce on Monday that his administration will carry out measures intended to give Americans faster access to low-cost generic versions of brand-name drugs, administration officials said tonight.

The plan, similar to but less extensive than a bill passed in July by the Democratic-controlled Senate, is intended to reduce the ability of manufacturers of brand name drugs to delay the approval and marketing of generic versions of their products.

With only 15 days to go before the midterm elections, administration officials were clearly eager to portray the president as engaged on the issue of prescription drug costs, a topic that polls suggest ranks high on the list of voters' concerns. Broader legislation to provide prescription drug coverage to retirees has been bottled up by partisan disputes in Congress. White House officials previewed the president's planned announcement in an abruptly scheduled conference call with reporters at 7:45 tonight.

In a speech in the Rose Garden, Mr. Bush is to say he will put in force recommendations by the Federal Trade Commission to make it harder for brand-name drug companies to exploit loopholes in existing law, the officials said.

This is a good start. I hope that we do get some speed on generics release.

I just received my September 30th issue of 'The Medical Letter'. I generally agree with their summaries. They are truly independent, receiving no moneys from the pharmaceutical industry. That issue has a nice review of dietary supplements. They point out that the 1994 law intending to keep the FDA from regulating vitamins and herbal products as drugs has led to our current problems. I will quote their conclusion (given after giving solidly referenced examples of problems with several supplements - both their danger and their inconsistency).

The main problems with dietary supplements, even if questions about their effectiveness and adverse effects were answered satisfactorily, are that their potency may vary and their purity is suspect. Physicians should tell their patients that we really don't know what's in them.

AMEN!

Generic Drug Delays Decried Anniversary Prompts Protest

On the first anniversary of the date that the popular heartburn medicine Prilosec was supposed to become available in a cheaper generic form, a coalition of government and business leaders complained Monday that continued delays are costing state and federal programs, as well as consumers, billions of dollars.

''This is a budget buster,'' said Brad Cameron, speaking for the coalition, Business for Affordable Medicine, which represents 12 governors and large corporations like General Motors and Wal-Mart.

The delay is also hurting Andrx, a Davie pharmaceutical company, which was the first to apply for a generic version of Prilosec -- a bid that has been tied up in court for more than a year.

This link is just a reminder. I have addressed this issue repeatedly. As I tell my housestaff - 'Just so No to Nexium'. (By the way, the AstraZeneca rep avoids me like the plague as I will not even sign for free samples of Nexium).

I vaguely remember Economics 101. During that course Dr. Elzinga taught us about elasticity. If demand for an item changes as the price changes, then demand is elastic to price. An article in this week's JAMA shows that drug spending is elastic to co-payments. Drug Spending Falls As Co-Payments Rise: Many Forgo Prescriptions, Study Finds.

This finding interests me. Patients can easily substitute some more expensive medications with cheaper OTC meds. However, I worry that patient's will have to forego necessary medications because of cost.

I am attending a journal club for our residents tonight. We will discuss a patient being discharged after a non-ST elevation myocardial infarction (NSTEMI). We will debate which of two drug classes the patient should use his limited resources to buy - clopidogrel (Plavix) or a statin. This hypothetical case obviously is very real to all practicing physicians. High drug costs are very real to patients, especially as the co-payment increases.

Abba Eban's famous comment, "The Palestinians never miss an opportunity to miss an opportunity." could apply to the pharmaceutical industry. Drug Makers Cutting Back on Discounts for the Elderly. My initial reaction to the headline was - STUPID! Then I read the article, and the explanations are not much better.

Bristol-Myers Squibb and GlaxoSmithKline said that they had raised the prices they offer in a widely promoted discount program out of concern that federal officials will demand similar deep discounts for the government Medicaid program, which provides health care for the poor.

But federal officials expressed surprise at the moves and said that they had not taken any action against the discount plans.

At issue is whether the discounts by the two companies — as well as those offered by five other drug companies, all under a program called Together Rx — are subject to a federal law requiring drug makers to offer the Medicaid program the lowest price available to any buyer.

For some of the 300,000 low-income people participating in Together Rx, the higher prices will hurt. For example, Bristol-Myers said it had been offering a month's supply of the cholesterol-lowering drug Pravachol for $15 to elderly people with incomes of $18,000 or less. On Tuesday, the company raised the price to $59.

Under GlaxoSmithKline's plan, patients will get roughly a 25 percent discount from retail drugstore prices, the company said, rather than 33 percent. For asthma patients, for example, an Advair Diskus will cost $118. Previously, patients paid $106 for that drug.

Thomas A. Scully, administrator of the Centers for Medicare and Medicaid Services, said this week that he was perplexed by the moves to reduce the discounts. "We have had hours of meetings with them trying to make sure we did not impact their discount programs," he said.

Mr. Scully said he believed that the two drug companies had decided to raise their prices for a reason unrelated to the government.

So what does this mean? Patients once again will choose between food and medications. If you are on a fixed income as subsistence levels, that is the choice. We can deliver outstanding medical care. It costs money. How will we pay?

Celebs step into generic drug debate Trade group ramps up efforts to thwart pro-generics bill. Give me a second to let the anger settle. Going to the BAM (Business for Affordable Medicine) web site, I found this article and quote Generic Drug Bill Encounters Growing Fight: Tauzin Won't Commit to Holding Vote on Politically-Charged Issue

Legislation designed to speed low-cost generic drugs to pharmacy shelves sailed through the Senate in July, but it has run aground in a House committee chaired by Louisiana Congressman Billy Tauzin.

Despite a broadly bipartisan Senate vote approving the measure, Tauzin has voiced doubts about the legislation, which is intended to make it harder for brand-name drug companies to use legal maneuvers to extend their patents and block cheaper generic competitors from getting on the market. Tauzin promised to hold a hearing soon, but he wouldn't commit to scheduling a vote on the popular bill.

"It's premature to say we will vote on anything until we have all the facts," he said.

Tauzin, R-Chackbay, has found himself at the center of a gathering storm over the politically sensitive issue of prescription drug prices as the Nov. 5 midterm congressional elections approach. The influential brand-name drug industry staunchly opposes the legislation, saying it will thwart innovative research. But double- digit annual increases in drug costs have drawn together a politically potent coalition of governors and corporate leaders demanding relief.

Legal maneuvering

The bill, by Sens. John McCain, R-Ariz., and Charles Schumer, D- N.Y., is designed to curb an increasingly prevalent strategy used by brand-name drug companies to extend their lucrative market monopolies and keep generic competitors at bay.

As their patents are about to expire, brand-name drug makers sometimes file lawsuits against generic drug makers that are poised to put lower-cost copycat drugs on pharmacy shelves. The lawsuits invoke a provision of the 1984 Hatch-Waxman Act, which, though intended to speed generics to market, instead gives brand-name drugs up to 30 more months of patent protection and market exclusivity while the dispute is settled.

A Federal Trade Commission study released on the eve of the Senate vote July 31, found that the provisions of Hatch-Waxman "may have prevented the availability of more generic drugs . . . (and) have the potential for abuse."

The FTC, a five-member board headed by a President Bush appointee, found that brand-name pharmaceutical companies, in particular makers of big-money "blockbuster" drugs, increasingly are filing multiple lawsuits against potential generic competitors and extending their monopolies years past the expiration of their patents.

The problem here comes from the pharmaceutical companies wanting to extend their patent protection. They do make a lot of money, even with their investments in research. I believe this bill would give balance and relief to patients.

Drug Industry Is Told to Stop Gifts to Doctors

The government warned pharmaceutical companies today that they must not offer any financial incentives to doctors, pharmacists or other health care professionals to prescribe or recommend particular drugs, or to switch patients from one medicine to another.

The government informed the industry that many practices commonly used in the marketing and sale of prescription drugs could run afoul of federal fraud and abuse laws.

Specifically, the government said that drug makers could not offer incentive payments or other "tangible benefits" to encourage or reward the prescribing or purchase of particular drugs by doctors, health plans or companies that manage drug benefits for employers and insurers.

The new standards, the first of their kind, were issued by Janet Rehnquist, inspector general of the Department of Health and Human Services, as guidance to the pharmaceutical industry.

Pharmacia's Hypertension Drug Approved

Pharmacia now has a green light from the U.S. Food and Drug Administration to market a new hypertension drug. Inspra, previously known by its generic name, eplerenone, is the first in a new class of drugs to treat high blood pressure. Analysts are expecting sales in the billions of dollars.

This drug - eplerenone - will probably create a much larger buzz than hypertension. Eplerenone is spironalactone without the side effects (or at least that is the plan). Spironalactone works well, but has a major rate limiting step - gynecomastia. With the latest data on spironalactone's effectiveness in severe heart failure (the RALES study), a major key for this new drug will be the results of ongoing heart failure studies. You can read more about this drug at Heart.org (free registration for physicians).

Buying Your Pills Online May Save You Money, But Who's Selling Them?

Because of growing scrutiny by both federal and state authorities, some online pharmacies have gone out of business. But some regulators say they continue to have serious concerns about the ways some companies operate. And they are worried about a large number of Web sites that still list only an e-mail address, as well as a rapidly growing number of online pharmacies that are based in Canada, beyond United States regulatory control, that cater to Americans seeking cheaper prices outside their own country.

Pricing continues to be an issue as well. Some studies have found that Internet shoppers can save 25 percent on the cost of prescription drugs, but the California State Board of Pharmacy, in a recent online shopping trip, found that some drugs cost up to five times as much on the Internet as they did at the local pharmacy.

Some regulators say they have also noticed a new slickness in the online pharmacy industry. They point to Web sites that now require a customer to release them from liability before they mail prescription drugs, as well as those that make a customer agree not to consume any prescription drug without first consulting a local physician. Some Web sites describe themselves as unbiased "information exchanges" for consumers who want to share tips about particular pharmacies, but the sites have no information about where they are based or whom they represent.

"Online pharmacies have gotten much more sophisticated than they were in 1999," said Richard Cleland, assistant director of the division of advertising practices for the Federal Trade Commission.

Carmen A. Catizone, the executive director of the National Association of Boards of Pharmacy, a professional group that represents pharmacy licensing boards in the 50 states, said his organization was receiving about two dozen consumer complaints a month about online pharmacies, with most of the complaints directed at roughly three dozen companies that have blanketed the Internet with hundreds, if not thousands, of Web sites.

Caveat emptor. But I do understand the buyer's motivation. Medications can cost a lot of money!

Some Retirees Look Abroad for Prescription Drugs. This article discusses how some patients decrease their drug costs. The pharmaceutical industry deserves to make a profit, but at whose expense. Read and think about the problem from the patients' perspective.

Lagniappe has an important article this week. He talks about patent law and the pharmaceutical industry. As Others See Us.

But let's be real. These days, when big-selling drugs go generic, their sales don't just slowly fade out like they used to: they drop off a cliff. HMOs aren't stupid, at least not when it comes to obvious cost-cutting measures. When Claritin goes off-patent, it's not going to matter whether or not the word "loratadine" is on everyone's lips; its sales are going to tank anyway.

Every drug company realizes this. So why is Pfizer (and the other companies that may be cheering them on) making such a request at all? It's not going to help; all it does is make the compan(ies) involved look slick and greedy. This is most definitely not the time to be looking slick and greedy.

He focuses here on a key point. The pharmaceutical industry feels slick and greasy (oops greedy). They have created that perception, especially amongst physicians .

He then bemoans the lack of recognition that the industry gets for major advances in patient care. The pharmaceutical industry has made an enormous contribution to treating many diseases and improving quality of life. But they still feel slick and greedy. They need a new approach. They need a bit less short term outlook and a more measured long term outlook.

Please read the entire article, it does provide some balance for my rantings.

U.S. Inquiry on Pricing of Prostate Drug

Nice article, reprinted from the Wall Street Journal - States, Insurers Find Solutions for Drug Costs describes succesful strategies for decreasing drug costs.

After a heart-attack scare, Ms. Hummel, 55 years old, visited her Kaiser Permanente clinic in Santa Clara, Calif., for a cholesterol check. Her readings weren't good: Her LDL, or bad cholesterol, was 195, nearly twice her recommended level. She got a prescription for a type of drug called a statin. Within a month, her LDL had fallen to 104.

It's the kind of outcome you'd expect from Pfizer Inc.'s Lipitor or Merck & Co.'s Zocor, two heavily advertised pills that are the top-selling statins. But Ms. Hummel took lovastatin, a generic version of a drug called Mevacor that Merck introduced in 1987. It's less potent than the others and has been largely ignored by company marketers since Zocor came out a decade ago.

But Mevacor, which went off patent last year, is plenty powerful for most patients. It is now the linchpin to an ambitious cholesterol-management program in Kaiser's Northern California Division. More than 80 percent of the division's 130,000 high-risk heart patients have reached federally recommended cholesterol goals, up from 22 percent five years ago. And, thanks to the drug's lower price and Kaiser's discount-generating purchasing power, the HMO can treat five patients with lovastatin for what it costs to treat just one with Lipitor.

Point well made! This is not an isolated example in the article. The problem remains educating physicians (including myself) on clinically proven alternatives. We hear more about the newer medications, and often forget the older ones. Where are the studies showing equivalence?

In the U.S., the FDA scrutinizes drugs for safety and clinical effectiveness, but no federal agency offers a comprehensive assessment of the economic value of drugs. Many private health plans attempt such research while creating their lists of approved drugs, but those data largely remain secret.

The National Institutes of Health, which conducts and finances basic research, sponsors occasional clinical trials comparing the performance of drugs. In 1994, the NIH's National Heart, Lung and Blood Institute launched a 44,000-patient trial to compare, among other things, four hypertension medications. The institute wanted to know which was more likely to prevent heart attacks and deaths.

Results of the study aren't expected until late this year, but already it has yielded an important finding. Patients taking a blood-pressure medication called doxazosin were more likely than those on a cheaper diuretic to have heart problems and be hospitalized for congestive heart failure. That prompted a call by the Heart, Lung and Blood Institute for one million Americans taking doxazosin to see their doctors about using an alternative.

But the NIH sponsors relatively few such studies, which are complex and costly. Increasingly, experts argue that the government should play a more active role in exploring the cost-effectiveness of drugs. ``We have a national institutute for heart disease, a national institute for diabetes, a national institute for allergies,'' says Harris Berman, chief executive of Tufts Health Plan in Waltham, Mass. ``Maybe we need a national institute for pharmacy.''

I have previously decried the lack of these practical and important studies. As long as we rely on pharmaceutical companies to fund research on their drugs, we will not get the studies that we need!

NY Times bashing has become great sport in the blogosphere. If one can bash them when wrong, then one must congratulate them when they are right. They have this one right. The Battle Over Drug Discounts

The Pharmaceutical Research and Manufacturers of America, a trade association, argues that the states have no right to press its members in this way after they have already negotiated prices with the federal government. Most of their arguments sound like procedural quibbles. In the private sector, health maintenance organizations and medical institutions have long used formularies, or preferred lists, to favor low-priced medicines and extract discounts. There is no good reason state Medicaid programs should not be allowed to do the same. If the Medicaid laws need to be modified to let that happen, then Congress should do so quickly.

The more difficult issue comes when states tell manufacturers they cannot be on a preferred list for Medicaid unless they offer discounts to non-Medicaid patients as well. Some states do this on behalf of the near-poor, but a few have pushed the idea further. Maine is demanding discounts for any resident who lacks insurance coverage for prescription drugs and wants to be part of the state program. The Maine case is headed for the Supreme Court, and the solicitor general's office has expressed doubts about its legality. Some patient groups fear that Medicaid beneficiaries will be harmed if manufacturers who would otherwise provide drugs for Medicaid drop out rather than grant discounts to the broader population.

I have noticed that I agree with the Democrats on this issue, and the Republicans on the trial lawyer issue. That probably makes me an independent - or I would claim a free and clear thinker.

The Patent Expiration Fun Continues - nice report by Derek Lowe of Lagniappe.

I found this letter to the editor in the Washington Times this morning. The entire letter is so important that I have copied it to the blog.

A chill pill for drug industry advocates

Nonsense. That is the best description of the opinions expressed by Peter Ferrara in "Poor prescription for health prospects" (Commentary, Thursday).

He states that members of Business for Affordable Medicines (BAM), working to close loopholes in the federal law that governs pharmaceutical competition, are "charlatans" seeking to "posture themselves on a high moral pedestal as champions of the poor, the sick, and the needy ."

The 1984 Hatch-Waxman Act was passed to protect patented drugs from competition by lower cost generic alternatives and to ensure robust generic competition as soon as possible after the patents expire. The result was a careful balance that ensured brand drug companies would invest in new drug research and that consumers could eventually get access to new cures at lower prices. Today, the brand drug industry has perfected a scheme to prevent generic competition well after the patents on their drugs expire.

Mr. Ferrara states that our advocacy of legislation to restore the balance intended by the Hatch-Waxman Act constitutes an "assault" on intellectual property and the patent system. He also claims drug companies will simply stop investing in research if their ability to market drugs without competition is affected in any way.

In fact, the Senate-passed bill does not change patent protections at all. Drug patents will still remain in effect for 20 years under the bill, an element demanded by our coalition members such as Kodak and Motorola, who are among the nation's largest patent holders. No BAM member will support any effort to undermine strong patent protections.

In addition, it is competition — not the lack of it — that drives pharmaceutical innovation. Drug industry spending for research has increased dramatically since 1984 as a result of, not despite, increasing generic competition.

Mr. Ferrara freely uses drug industry propaganda to conclude that "cures will dry up" if our efforts to bring free-market principles back into the equation are successful. He claims the average new drug costs $800 million to produce, without pointing out that only the drug industry uses this figure with a straight face. The data to support it is based entirely on internal surveys that have never been shared with outside auditors. He also fails to point out that, despite this, the brand pharmaceutical industry is more profitable than any other industry in the world, according to Forbes magazine.

The Federal Trade Commission reported last month that the industry has perfected schemes to "game" the system, and encouraged Congress to act now. The Congressional Budget Office has determined that bills to close loopholes in the Hatch-Waxman Act will save purchasers — including taxpayers — $6 billion annually.

Mr. Ferrara also implies that increased use of generic drugs "are a threat to the public health." He fails to assure the public that the FDA requires all generics to be bioequivalent to the brands they replace and to provide the same levels of safety and efficacy.

By passing Hatch-Waxman reform legislation, Congress has an opportunity to provide significant prescription drug cost relief to voters this year — and without costing taxpayers a dime. Despite drug industry claims, restoring competition to the pharmaceutical industry is the best prescription for the health of Americans and the industry.

WILLIAM JANKLOW
Governor
South Dakota
Pierre, S.D.

This well written letter defines the battle. With some researching, I found BAM's home page - Business for Affordable Medicine includes the nation's leading employers, organized labor, and governors. BAM was established to improve employee access to affordable health care through reform of the federal Hatch-Waxman Act.

The good and bad of going over-the-counter Physicians often have mixed feelings about drugs going OTC. This article gives a nice balance and puts the decision into appropriate perspective. I will briefly discuss 2 drug classes.

Women can now self treat for candida vaginitis. Most women know when they have it, and the treatment usually works well. However, other infections can cause vaginitis. Some vaginitis is not infectious. So some women will waste money and time by self treating incorrectly.

Proton pump inihibitors (Prilosec, Prevacid, Aciphex and the hated Nexium) are a class of drugs which inhibit acid secretion in the stomach. The give relief to ulcers, simple gastritis, and most important GERD (gastroesophageal reflux disease - known to most as the disease associated with heartburn). We already have the histamine 2 blockers OTC (Tagament, Pepcid, Zantac) for these conditions. PPIs work better. So what is my concern? Heartburn or abdominal pain may herald a more serious condition. I believe that my history taking would give me some clues to evaluating some patients further. Gastroenterologists see the worse cases of GERD - which often have complications like stricture or even cancer. If patients self treat for years, they may miss the opportunity for better diagnosis and treatment. On the other hand, OTC equals lower prices for PPIs. The article gives the right balance. I do want OTC Prilosec, but I want patients to still talk to me about the problem periodically.

Poor prescriptions for health prospects

But this private American industry of miracle-makers and lifesavers is now under assault from all directions. Many people apparently want the miracle medicines without paying for them, or paying nearly enough to keep them coming.

Charlatans are rushing forward to posture themselves on a high moral pedestal as the champions of the poor, the sick, and the needy in attacking the pharmaceuticals. But all these self-appointed saviors have never produced one drug or medicine that has ever benefited anyone.

This has been reflected in the still pending congressional debate over a Medicare prescription drug plan. The Senate bill would allow unrestricted importation of American-made drugs from Canada, purchased under Canada's price controls. Moreover, even in the U.S., Medicare reimbursement under the pending plans would fall far short of market prices.

Such provisions would drastically reduce the revenue flow to the pharmaceuticals. That would in effect sharply slash the nation's true budget for research and development of miracle drugs.

Solid profits on the drugs that work are necessary for a time to make the whole process of modern biomedical drug development viable. The research and development is highly expensive, an average of $800 million for each new drug, and the investment in it is very long term, for it takes well more than 10 years for a successful research effort to start making any money.

Pardon me while I hyperventilate. The pharmaceutical industry has good features. New drug classes often help patients greatly. I and most physicians greatly appreciate the advances of the last quarter century - statins, ACE inhibitors, ARBs, quinolones, proton pump inhibitors, etc. What this guy ignores is the greed of some companies. They deserved a good return on Prilosec. They have no excuse for Nexium. Likewise Claritin and Clarinex. They do not need to raise prices each year at a greater percentage than the cost of living. I favor the free market, but this is not the free market.

Drug Cos. Seek Ban on Price Lists.

A coalition of drug makers sued Health and Human Services Secretary Tommy Thompson for approving Michigan's 6-month-old "preferred drug list" program for Medicaid recipients.

Medications can only get on the list if its manufacturer agrees to offer the drug at a steep discount. If doctors want to prescribe a drug not included on the list, they must get prior approval from the state.

"State programs that restrict access, we feel, violate federal law and can result in harmful consequences to the country's most vulnerable patients," said Jan Faiks, a lawyer for the Pharmaceutical Research and Manufacturers of America or PhRMA.

PhRMA wants U.S. District Court Judge John Bates to stop Michigan's program and similar initiatives in other states. Florida and Louisiana also have the preferred drug list programs, while Connecticut, Missouri, Hawaii, Illinois, Minnesota, Mississippi, New Mexico, North Carolina, Ohio, Vermont and West Virginia are in various stages of implementing such programs, according to PhRMA.

'Spokesmen for the Department of Health and Human Services and the Michigan's Department of Community Health declined to comment on the hearing Wednesday. ' And I refuse to comment.

States Sued For Pushing Cheaper Drugs Via Medicaid . Just when I think about taking it easy on the pharmaceutical industry - there they go again.

The most popular strategy is requiring prior authorization for high-priced medicines. More than a dozen states are developing preferred drug lists, and several demand extra rebates from companies that do not match the lowest price. Michigan's new program saves $800,000 each week -- or $42 million this year, according to Republican Gov. John Engler.

Oregon expects to save $17 million in the first two years, which would result in nearly $40 million in savings for the federal government, said John Santa, administrator of the state health policy office. Massachusetts and Vermont say they could save $10 million.

If the industry suits are successful, "it will throw the country into chaos," Rivers said. "There are too many big states whose budgets would be devastated by it."

Drug manufacturers argue that prescription medication saves lives and money by preventing emergency room visits and more expensive procedures such as surgery.

"The most economic service [states] can provide is adequate access to prescriptions because it gives the most bang for your buck," Faiks said.

"The Medicaid Act does not let them use prior authorization to hold patients hostage because of money," she said. Although PhRMA objects to the state tactics, the industry is suing the federal government in U.S. District Court in the District of Columbia on the grounds it does not have the authority to permit the state programs. In the lawsuits the industry is challenging the state programs, arguing that the government is more concerned with cost than the health of low-income residents.

PhRMA's legal brief contends that "physicians generally respond to the inconvenience and burden imposed by prior authorization requirements by switching their patients" to a drug on the preferred list. Over time, the suit notes, the shift in prescribing patterns results in large swings in the overall market.

If I understand the pharmaceutical industry, I should use the most expensive drugs to save the most money. Sometimes a very expensive drug makes a difference, but often we can treat the same condition with a less expensive alternative. Working with the indigent and working poor, I have learned to use captopril as my ACE inhibitor of choice for hypertension - because it is generic, very inexpensive, and works at a twice a day dosing for hypertenion. Should I switch to a more expensive antihypertensive?

This is a very serious issue. I will try to stay aware of the developments, but if I miss them, and you see them, please let me know.

Prescription drugs to have and to have not. Read this nice opinion piece about celebrity interviews and the pharmaceutical industry.

CNN to Reveal When Guests Promote Drugs for Companies

After learning that some celebrities who talked on its news programs about their health problems were being paid by drug companies, CNN has issued a new policy and will tell viewers about the stars' financial ties to corporations.

CNN will ask celebrities who want to talk about a medical issue whether they are being paid by a company, the network said. If so, the financial tie will be disclosed during the interview, CNN said.

Other news programs — including the "Today" show on NBC, "Good Morning America" on ABC and "The Early Show" on CBS — say that they have also become more careful after they learned that some Hollywood celebrities they had interviewed, including stars like Lauren Bacall and Kathleen Turner, had been paid to help promote drugs or other medical products on their programs.

Pharmaceutical companies have one interest in mind - selling their drug. Jane Galt would probably say that is appropriate in a free market. I would say that society has an interest in minimizing influence which does not necessarily correlate with patients' best interests. I like this development. I believe that I can do a better job recommending medical care than celebrities.

As indicated last month, we will probably soon have our first over the counter proton pump inhibitor - FDA gives conditional OK to nonprescription Prilosec

THE COMPANY said it received a so-called approvable letter from the FDA and now expects to begin commercial nonprescription sales of the drug in the first half of next year.

P&G owns rights to an over-the-counter form of Prilosec, the “purple pill” produced by drug maker AstraZeneca Plc. Prilosec, which generates about $6 billion a year in sales, was the world’s top-selling medicine before its patent protection expired last year.

The approvable letter says final FDA clearance will be granted after a study is conducted to make sure that consumers understand the drug’s labeling, said Dr. Greg Allgood, associate director of the Procter & Gamble Health Sciences Institute.

I have mixed feelings about this announcement. The financial implications are probably very positive. History suggests that patients will pay less for an OTC drug. However, I do worry about patients figuring out when to come in for evaluations - especially with chronic gastroesophageal reflux.

Just Saying No to Gifts From Drug Makers. And remember my new motto - just say no to Nexium. Gifts work, that is why they are used. Robert Cialdini has studied the psychology of influence and written widely on the subject - Influence: How And Why People Agree To Things by Robert Cialdini. The link gives a summary of his findings. The first method used in obtaining influence is reciprocity . When we accept gifts from the drug rep, and we are confronted with choosing between 2 or 3 equivalent drugs, we just might use their drug - this represents reciprocity. This factor does not rule our decision making - rather it influences it. That is what the drug companies want. That is why we gain when we say no. The pharmaceutical industry understands it - and their new rules should level the playing field. They will divert their moneys to direct to patient advertising (in my opinion) and try to influence us that way.

Read this story from Lagniappe (barf bag not included) - Great Moments in Legal Reasoning. No commentary here - just read the link.

Study: Tobacco firms tried to weaken anti-smoking aids. This story stinks so bad, that I may have an anxiety attack.

Regular readers know how I worry about the pharmaceutical companies. Read this excellent summary by the Blovi8or of the new rules - A CHANGE IN PITCH FOR DRUG REPS. This story bears watching - can they really regulate themselves?

We report, you decide. I am not the first to point out this story, but it is a huge story. Unfortunately, I am not surprised - Celebrity pill pushers. Does anyone want to defend this?

I hate typing this. FDA Rebukes Maker Of Diet Drug Meridia

The Food and Drug Administration has told the maker of the diet drug Meridia that it violated federal regulations by failing to properly report the deaths of patients taking the drug.

In a letter to Abbott Laboratories made public yesterday, the FDA said that information about seven deaths associated with Meridia was not reported properly to the agency, that one death was not reported at all, and that reports on three other deaths were incompletely reported.

Why are they not thinking? What are they trying to hide? This makes me very unhappy.

The pharmaceutical industry refers to sales calls as detailing. I hate being detailed. However, detailing works. Research has also shown that one can counteract detailing by using this weapon to clarify drug information. Now insurers and prescription drug benefit organizations are taking the academic research and using counterdetailing to decrease drug costs -
Doctors Hear Alternatives To Drug-Firm Sales Pitches

Drummond is a "counterdetailer" -- a paid consultant for a prescription benefit company whose job is to question those sales pitches, to counsel doctors to look at cheaper and generic drugs whenever appropriate. And the rise of this figure in the health care landscape has opened another front in the battle to control prescription drug costs, which have been rising more than 17 percent yearly since 1997.

...

Then there are counterdetailers, targeting doctors. The states of West Virginia and Michigan have hired their own counterdetailers to visit doctors and encourage them to prescribe generics whenever possible. Legislators in other states, including Vermont, Massachusetts and Washington, have proposed or passed similar programs. First Health Group Corp., which manages prescription benefit plans in 14 states, reports that the states' interest in counterdetailing is growing fast.

...

Persuading doctors to prescribe generics -- and patients to use them -- can bring enormous savings. As explained by Tom Susman of the West Virginia Public Employees Insurance Agency, 43 percent of prescriptions paid by the plan are now generics. If that number grew to 45 percent, he said, the state would save $1 million. That's why he is beginning the state's counterdetailing program, and why the work of people like Marcia Drummond is drawing increased interest.

She works for the prescription benefit company AdvancePCS, which has its own financial reasons for wanting to control drug costs but whose goal is shared by many others, including some generally critical of managed care. New York doctor Robert Goodman, for instance, who runs a program that highlights improper drug-company promotions to doctors, applauds private counterdetailing efforts because "it's essential that doctors get drug information from sources other than just drug company reps."

The AdvancePCS program began several years ago, and now sends out 150 counterdetailers to visit 20,000 of the nation's top prescription-writing doctors each year. The goal, as Drummond described it, is to discuss with doctors the drugs they're prescribing to make sure the patients are getting the most appropriate -- and least expensive -- medications.

All I can say to the pharmaceutical industry is ' Take that!!!'. This is constructive, and I hope the government figures out the benefits of this approach. I only worry that costs do not bias the information given to physicians. I suspect we will read more about this approach over time.

As a physician, we must all learn the lesson. Knowing what to do is just the first step to treating a patient. Next one needs the patient to want to participate in their care. Many patients just do not want to take the medication, either because I did not explain it properly, or because they do not accept our medical model. Finally, the patient must have the resources to obtain the medication. Increasingly, that is the problem. Danger of Unaffordable Drugs: Older Americans Risking Their Lives to Save Money on Medicine. All physicians who have asked know this problem. The reporters did not have to search long to find this example.

Some will say that the pharmaceutical industry provides drugs to the needy. Cold Fury pointed out a web page devoted to those programs - Needymeds.com ...because everyone should take their medicine. Unfortunately, these programs are a pain in the butt for physicians and their staff. Each company has its own form, and criteria for inclusion. They generally mail the drugs to the physician's office, turning us into a dispensary. Read the article - it describes the problem well. It does not give a solution. That is realistic.

Just when I thought I understood all the pharmaceutical industry tricks, bingo, they have a new one. First, you market the disease... then you push the pills to treat it

The modus operandi of GlaxoSmithKline - marketing a disease rather than selling a drug - is typical of the post-Prozac era. "The strategy [companies] use - it's almost mechanised by now," says Dr Loren Mosher, a San Diego psychiatrist and former official at the national institute of mental health. Typically, a corporate-sponsored "disease awareness" campaign focuses on a mild psychiatric condition with a large pool of potential sufferers. Companies fund studies that prove the drug's efficacy in treating the afiction, a necessary step in obtaining FDA approval for a new use, or "indication". Prominent doctors are enlisted to publicly affirm the malady's ubiquity, then public-relations firms launch campaigns to promote the new disease, using dramatic statistics from corporate-sponsored studies. Finally, patient groups are recruited to serve as the "public face" for the condition, supplying quotes and compelling stories for the media; many of the groups are heavily subsidised by drugmakers, and some operate directly out of the offices of drug companies' PR firms.

I got this link from a comment at The Safety Valve. Cold Fury started a stir Those Greedy Pharms. He discusses (amongst other things) free drug programs for the needy, the cost of clinical trials, and the problems of big government. I found it worth reading.

FTC Seeks Generic Drug Delay Limits

The Federal Trade Commission wants to limit the ability of drug companies to delay the marketing of generic competitors and to require the firms to disclose agreements covering the sales of generic drugs.

``The commission's recommendations today are designed to accomplish two goals: to facilitate generic entry and to maintain appropriate incentives for the development of new drug products,'' said FTC chairman Timothy J. Muris.

Hopefully, this recommendation will allow faster entry of generics into the market.

As I have come to expect, medpundit has written an excellent piece on drug pricing. Her numbers are chilling; her reasoning sound. The Sky’s the Limit:

I often give an impromptu talk on rounds about how medicine has changed since I graduated from medical school (class of 1975). We laugh about many things that I was taught. We marvel at the advances. As I share my personal view of medicine over the past 25+ years, I am often amazed at the advances, but also at our naivete.

Ann Patchett, writing in the New York Times Magazine, has written an essay - Estrogen, After a Fashion - which mostly looks at how estrogen use has changed over the years. Embedded in that discussion, she makes some very important observations.

What we want is for medicine to be a science. We want competent, well-informed doctors to give us consistent answers based on exhaustive research. We want them to be right. But medicine is a peculiar combination of science and fashion, half penicillin, half shoulder pads. It takes what is known at the moment, combines the knowledge with what the consuming public wants and comes up with a product. One doctor endorses the product, and while you can always go for a second opinion, it's hard to stop at just two, especially when the opinions turn out to be in direct conflict with one another. Read the papers. One doctor says to discontinue Prempro immediately. Another says more studies are needed and what we're facing is a massive overreaction. In the end it will be up to you, who never went to medical school, to make the decision your life may depend on, and while there might not be one definitive right answer, you can bet on the fact there are plenty of wrong ones.

She has much more to say, and even comments (from a consumer perspective) on pharmaceutical direct to patient advertising.

This week Jane Galt and I have had a stimulating discussion - Discourse with Jane Galt. Many interesting issues have arisen, and today I would like to focus on knowledge.

The chief of Cardiology discussed Congestive Heart Failure (CHF) at this week's Medical Grand Rounds. During his presentation, he discussed a variety of medical devices available for managing severe CHF. He made an important observation when he pointed out the the device manufacturers had no interest in funding studies which carefully delineate which patients should benefit from a particular expensive device. They would rather show efficacy, and do not apparently mind if physicians implant excess devices (two examples include automatic implantable cardioverter defibrillators (AICD) and atrial synchronous biventricular pacing (ASBP)). Each of these treatments cost approximately $30,000 per patient. We know that in carefully designed studies and carefully selected patients these devices work, improve quantity and often quality of life. We do not know the proper indications for the devices. For ASBP in particular, data suggest that not all patients benefit. Cardiologist would benefit from studies which examine predictors of efficacy. The device manufacturer will not fund these studies, and given our current regulations they have no such obligation. Economic advisors would tell them not to limit the potential market, and the right efficacy study would limit their market. Thus, the economic incentives for society (use these expensive devices only in those patients likely to benefit) clash with the economic incentives for the device manufacturer (sell as many devices as feasible).

A naive response comes to mind. Let the NIH fund the study. But the NIH (actually in this case the NHLBI) will probably not fund that study, stating that they have higher priorities for their research dollars. Medicare rarely funds such studies - their bureaucracy does not seem to understand the importance of efficacy studies.

Let me switch to a pharmaceutical example. Adult onset diabetes mellitus causes more kidney failure than any other disease in the United States (and probably the world). We have learned much about the onset and progression of kidney disease in diabetic patients. We know that very small amounts of protein in the urine predict eventual kidney failure. We have learned that we can both decrease the amount of protein in the urine (without treatment these small amounts become grams of protein) and delay or even prevent the onset of kidney failure.

Recently published studies (for those interested, I have a slide series available from a talk I gave on this subject last year - Update in Nephrology) have documented both a decrease in urine protein and delayed progression of kidney disease. The studies that I cite in that talk all used a class of antihypertensives called angiotensin receptor blockers (ARBs). Of interest, earlier research in patients with childhood type diabetes used angiotensin converting enzyme inhibitors (ACE-Is). The firms that produce ARBs funded the recent studies. They have not, and likely will not fund studies to compare ARBs and ACE-Is. The ACE-I manufacturers will not fund any studies, because those drugs are nearing their patent expiration (at least 2 of that class have available generics, and that number will increase soon). One would expect that the ACE-Is should work as well as the ARBs, but how can we find out? One could easily design that study, but such studies are very expensive. No manufacturer has a financial incentive to fund the desired study, and the NIH apparently will not fund such a study.

We need a new mechanism to insure that we fund important clinical studies. The current system works only when it benefits the manufacture or the issue is so large that the NIH funds the work.

Therefore, I make this modest proposal. We should charge a research fee to device manufacturers and pharmaceutical manufacturers. I have not worked out whether a fee or a research tax makes more sense. We would then have moneys to fund efficacy studies. An expert clinical panel would prioritize proposed studies, and fund them in order until that year's moneys expire. This would allow us to do the right studies.

I suppose that this idea has many flaws. It seems too simple to work. What do you think? How important are efficacy studies? Can we fund the right ones?

Since I responded to Jane Galt's discussion of pharmaceutical company budgets, and particularly marketing, I felt it polite to let her know of my discourse. She kindly emailed this reply

I think we're arguing two different things. Doctors who (forgive me) are a little irrational on the subject of pharma advertising, are arguing that in some sort of ideal world, there would be no marketing. There are a couple of ways in which I think this is ill-informed; in fact, it costs pharmas a lot less to do junkets than it would to do advertising or direct mailings, which have a much lower hit rate; similarly, it costs them less to have sales reps than it would to staff a hotline 24-7. Physicians, left to their own devices, apparently have a very poor record of tracking developments in pharmaceuticals; those marketing efforts do serve a purpose, and in fact do so at a lower cost than many alternatives.

But I certainly wouldn't dispute that there are excesses in the marketing budget, or that pharmaceuticals attempt to get people to take drugs when there are perfectly viable alternatives that are cheaper and just as good. However, the question I was asking is not whether in some ideal world there would be less marketing, but whether lowering drug prices would have the effect of lowering R&D or marketing spending; I think that the evidence indicates that it would be the former rather than the latter. And as you are probably well aware of all the ways in which nationalizing health care would call quality of care to suffer, you should not have difficulty understanding why I believe that there would be similar effects on pharmaceutical research.

So I'm not making an ethical judgement on what I think should happen, but an analytical judgement on what I think will. And I think that reimportation would damage R&D beyond repair. I view the excessive advertising etc. as a small transaction cost to pay for a largely efficient research process.

I do take umbrage in the generalization that physicians have a poor record of tracking developments in pharmaceuticals. The longer one practices medicine, the more cautious one becomes over the latest and greatest advancement. I have seen too many new drugs found to have major side effects after FDA approval. Unfortunately, sometimes the pharmaceutical company had strong clues, but acknowledgement of difficulties would hurt their marketing efforts.

I believe that there remain major rewards to new drug development. I'm in favor of a reasonable return on investment for advances. I am against the aggressive marketing of "me too" drugs. I am against legal games which delay the introduction of generics. I am against direct to patient advertising for a variety of reasons. When patients ask for a certain medication, I either have to spend time (and time is money) explaining why I do not want to use that drug, or I could just relent and prescribe the drug (even when it is not the best choice). That form of advertising places the physician in an uncomfortable position, can negatively impact the doctor-patient relationship, and rarely benefits anyone (other than the drug company).

There are many new pharmaceutical companies. They are all trying for the big new advance. NIH basic science research allows new ideas and approaches. Not all drugs come from pharmaceutical sponsored research. I really do not believe that research will go out of business if prices decrease (by whatever means).

Finally, I would argue that ethics should trump economics here. The implications of selling your drug by buying influence with physicians are worth considering. This is a societal concern. We should strive for the best care, not care which benefits AstraZeneca (to pick on my favorite target). Who is looking out for the patient? I believe that is the crucial question here. (db steps back off his soapbox - only to return in the near future).

Blovi8r just emailed me this link (which he has on his web site also) - This Promotional Pen Works so Great, Imagine how Well the Drug Must Work. This comes from the Onion and as one would expect is hilarious. Thanks Bloviator!

Medpundit showed me the link to this long diatribe by - Jane Galt. Now I do not know Jane Galt, but I suspect she has not been on the receiving end of drug company marketing. I do understand the economics of new drug development. I understand market share. I do not understand the ethics of pharmaceutical company marketing.

We have this problem in medicine. We want to find truth, not opinion, not guesswork, but truth. When confronted with a patient who has just entered menopause, I want as much information as possible to help her decide on potential prevention measures. I would like to either have read the literature, or have a competent expert summarize that literature as an aid to our decision making.

The pharmaceutical companies have a different incentive. They want us to use their drug, at the highest feasible price. Given two potential drugs for the same indication, they will always "spin" the drug that they sell. Understanding their profit motive (which is not a bad thing per se), I understand that they do not necessarily care about the best therapy. They care that we use their therapy. Thus, they work hard to influence us. Influence comes in many forms (for a good start on understanding influence - Influence At Work: The Psychology of Persuasion). That is their job, but I do not have to like it. I prefer to obtain information from unbiased sources. I object to the flagrant boondoggles that they fund (dinner at expensive restaurants, vacations, tickets to football games, etc.).

Each company seems to function under a different ethic. I find some companies more acceptable in their tactics. The general feeling we physicians have is that the drug reps are just salespeople, they rarely provide useful information, they are JUST SELLING. That is my objection.

I was working with an intern in clinic yesterday afternoon. The Wyeth representative had bought him dinner the previous night (actually dinner for the entire team on call). That rep was downplaying the HRT study results. He got directions from the company. Wyeth Criticizes Media Coverage of Hormone Replacement Drugs

The chief executive of Wyeth, Robert A. Essner, criticized the media yesterday for what he termed its "sensationalizing" of a study that found that the company's hormone replacement therapy, Prempro, did more harm than good.

"Once the media sensation over the study subsides, the data will speak for themselves and hormone replacement therapy will remain an important part of women's health care," Mr. Essner said in a conference call with analysts.

To Wyeth's credit they paid for the study. However, I am very tired of drug rep and drug company spin. Reps are salepeople. They always have the BEST drug compared to their competitors. Nothing is every wrong. one gets tired of the spin. Thus, I cannot believe anything they say. I must go elsewhere for drug information. So should you!

Bloviator's permalinks do not work properly - so - click on Bloviator and go to Thursday, July 18. The Bloviator makes several excellent points about detailing. As I have documented previously, we theoretically have some new limits on direct to physician moneys. Nonetheless, I agree with the points made. I have not yet become totally radicalized over this issue (to read the most radical position go to No Free Lunch), but they are pushing me. Read Bloviator's comments, they are accurate and appropriate!

An 80 year old gentleman with whom I used to play golf, has a large medication bill. He imports his drugs from Canada. Is that legal? The Senate would like to make this easier. Plan to Import Drugs From Canada Passes in Senate

But today his administration opposed Mr. Dorgan's proposal. In a letter to the Senate today, Dr. Lester M. Crawford, deputy commissioner of the F.D.A., said:

"The bill would create an incentive for unscrupulous individuals to find ways to sell unsafe or counterfeit drugs that while purported to be from Canada may actually originate in any part of the world. Canada could become a transshipment point for legitimate or nonlegitimate manufacturing concerns throughout the world. In many cases, we would not be able to determine the true country of origin."

Counterfeit drugs could easily be commingled with authentic products, and "there is no sampling or testing protocol sufficient" to detect them, Dr. Crawford said.

I suspect that we will hear more on this issue.

Surprise, surprise, surprise - Drug industry ad spending attacked: Top companies spend twice as much on ads as research.

The group’s report, which uses numbers from the annual reports of nine leading drug companies, shows, for instance, that Merck and Co. Inc., which reported $47.7 billion in revenue in 2001, spent $6.22 billion or 13 percent of that on marketing, advertising and administration.

Merck reported a net income, or profit, of $7.28 billion —15 percent of revenue, or triple the $2.46 billion it spent on research and development, Families USA pointed out.

Pfizer, which makes the blockbuster Viagra impotence pill, spent 35 percent of its $32.2 billion in revenue on marketing, advertising and administration and 15 percent on research and development.

“When Families USA attacks our promotional spending, they are really attacking the $10 billion in free drug samples that we give away each year to doctors who often use these free medicines to help needy patients.”

But Pollack said the numbers, available in each company’s annual report, speak for themselves. “At the same time drug prices are skyrocketing, drug companies are spending more and more promoting their drugs,” he said.

While free drug samples do help many needy patients, their purpose is to influence which medication we start. Once a medication works, we rarely change to another in the same class. The industry has the attention of Congress, and that is not good for the industry. Maybe patients can benefit.

Survey Halted, Drug Makers Seek to Protect Hormone Sales

When female patients have asked in recent days whether they should continue taking Prempro, the hormone replacement therapy, doctors have told roughly half of them to stop taking the drug or to switch to an alternative treatment, a survey of doctors has found.

The survey of 338 doctors, conducted last Friday by ImpactRx, a drug marketing intelligence firm, bodes poorly for sales of Prempro and for the drug's maker, Wyeth.

For example, sales representatives from Eli Lilly told doctors they visited last week that the company's drug Evista was a safe alternative to hormone therapy, according to the ImpactRx survey.

"We're doing a lot of education," said Lauren Cislak, a Lilly spokeswoman. She said the company wanted to make sure that patients and doctors knew that Evista did not include estrogen or progestin, like Prempro and the other hormonal treatments.

Merck & Company ran a full-page ad in The New York Times on Sunday, promoting Fosamax, another drug that treats osteoporosis. The ad made it clear that Fosamax is a nonhormonal treatment.

"We're encouraging women to have a discussion with their doctor," said Gregory Reaves, a spokesman for Merck.

We all love that quote - encouraging women to have a discussion with their doctor - a euphemism for telling your doctor what you want. I actually recommend olendronate (Fosamax) as a first line prevention and treatment for osteoporosis. I just object to the advertising tactics of the pharmaceutical firms.

Readers of this blog know how upset I am over AstraZeneca's shenanigans in delaying generic omeprazole and releasing Nexium. The marketing budget for Nexium is staggering. I can not view MSNBC Health without running into a Nexium add. I see purple in my nightmares - and it isn't even a pill - it's a capsule!

Last week I made a major decision. The AstraZeneca rep asked me to sign for free samples of Nexium for our resident's clinic. I refused. I will not approve the use of Nexium for any patient - even if the drug comes for free. Rabeprazole (Aciphex) and lansoprazole (Prevacid) are my preferred proton pump inhibitors now - for pricing reasons. When Prilosec OTC is released I'll recommend that (AstraZeneca is not handling Prilosec OTC). I will avoid AstraZeneca products as much as is feasible.

I understand that my colleagues have signed for the samples. I understand that my protest will not accomplish much. But I feel good about this protest. Maybe one or two of you will join me. Who knows - it could become a movement? Your course is simple - just say no to Nexium. (db steps off the soapbox temporarily)