May 06, 2004
But our generics are cheaper!
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
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.
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April 30, 2004
Controversy over the Medicare drug discount card
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).
February 24, 2004
More on pharmaceutical influence
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.
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.
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On pharmaceutical influence
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.
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:
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.
February 19, 2004
An interesting take on the pharmaceutical industry
No ranting - just a link - Pop That Pill This is how the article ends - the leadup is worthwhile also -
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February 05, 2004
Clapping for the FDA
Tell the consumers about side effects! US FDA Wants Ads for Medicine to Highlight Risks
To which I must clap wildly! Now let us have the same guidelines for supplements and then I will do a jig!Posted by at 08:07 AM | Comments (4) | TrackBack (0)
January 20, 2004
On drug companies and residents
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.
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January 14, 2004
Drug company sponsored research
A reader sent in this link. It is a good one. Foregone conclusions
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January 01, 2004
A reader posted this comment/question today:
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.Posted by at 04:41 PM | Comments (2) | TrackBack (0)
November 25, 2003
On the pharmaceutical industry
Derek Lowe is always good. This rant exceeds even his high standards. Things Only a Friend Can Tell You. Please go read it.Posted by at 05:37 PM | Comments (0) | TrackBack (1)
November 24, 2003
Letters to the editor re: Relman
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)Posted by at 10:58 AM | Comments (2) | TrackBack (0)
November 18, 2003
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.
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
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.
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October 24, 2003
The Lancet - Astra-Zeneca controversy
Wow! The Lancet has laid down the gauntlet. The statin wars: why AstraZeneca must retreatThe editorial ends:
And Astra-Zeneca responds: (warning, pdf file) The response.
The BBC news has this article on the subject: AstraZeneca defends its new bestseller
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, HamletPosted by at 08:51 AM | Comments (2) | TrackBack (0)
October 09, 2003
Eplerenone approved for CHF
I have blogged extensively on eplerenone in the past - just do a search to find the articles.Posted by at 06:00 AM | Comments (1) | TrackBack (0)
September 29, 2003
On DTC drug ads
Most physicians dislike direct to consumer (DTC) advertising. Apparently we are in the minority. F.D.A. Reviews Ads for Drugs
Balderdash! I agree more with the following quote.
I remain skeptical of these ads. However, it does appear that they will remain for the near future.Posted by at 10:46 AM | Comments (4) | TrackBack (0)
August 20, 2003
The PPI battles
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
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.
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.Posted by at 06:58 AM | Comments (5) | TrackBack (1)
August 10, 2003
A doctor talks about pharmaceutical industry influence
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.Posted by at 06:07 AM | Comments (4) | TrackBack (1)
August 08, 2003
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!!).
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.Posted by at 09:34 AM | Comments (1) | TrackBack (0)
August 01, 2003
Derek Lowe on drug development
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.Posted by at 06:16 PM | Comments (0) | TrackBack (0)
July 31, 2003
More on drug reimportation
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
If this works, the straw man argument about investing in research may move towards moot.Posted by at 11:58 AM | Comments (1) | TrackBack (0)
July 30, 2003
The National Review reports and you decide - in favor of drug reimportation!
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.
This article has tipped the balance. I am no longer confused over this issue. I clearly favor drug reimportation!Posted by at 08:09 AM | Comments (3) | TrackBack (1)
The NY Times reports - you decide - on big pharmacy and drug reimportation
I need not comment - but maybe you will!Posted by at 07:40 AM | Comments (2) | TrackBack (0)
July 27, 2003
A letter to the editor about the pharmaceutical industry
We need them, but darn it could they just act a little more responsibly. (I know, they are acting responsible to their share holders).Posted by at 02:56 PM | Comments (4) | TrackBack (0)
July 26, 2003
Disagreeing with a reader's comment on the pharmaceutical industry
A stellar commenter, RG, writes:
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.Posted by at 07:59 AM | Comments (3) | TrackBack (0)
July 25, 2003
The House passes the re-importation bill
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.Posted by at 11:23 AM | Comments (3) | TrackBack (0)
The pharmaceutical industry dilemma
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.
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.
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 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.Posted by at 08:25 AM | Comments (2) | TrackBack (0)
July 11, 2003
Phamaceutical companies try to deny the truth
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
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.Posted by at 06:24 AM | Comments (5) | TrackBack (0)
July 06, 2003
Do anti-pharmaceutical groups inhibit new HIV drugs?
This commentary implies that anti-pharmaceutical industry organizations are having a negative impact on future development of HIV drugs. AIDS drug incentive dilemma
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.Posted by at 07:43 AM | Comments (2) | TrackBack (0)
July 03, 2003
Robert Goldberg on Canadian drug importation
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:
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.Posted by at 01:05 PM | Comments (3) | TrackBack (0)
June 21, 2003
The little pink pill
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.Posted by at 06:04 PM | Comments (3) | TrackBack (0)
June 20, 2003
Senate moves on generic drug bill
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:
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.Posted by at 08:25 AM | Comments (0) | TrackBack (0)
June 13, 2003
Bush on generics
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.Posted by at 05:49 AM | Comments (0) | TrackBack (0)
June 07, 2003
In favor of increasing OTC
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.Posted by at 05:25 PM | Comments (2) | TrackBack (0)
May 31, 2003
The pharmaceutical industry's insidious influence
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.
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.Posted by at 06:19 PM | Comments (0) | TrackBack (0)
May 30, 2003
The whistle blower and Warner-Lambert
This case, like most whistle blower cases, will become nasty. Court Papers Suggest Scale of Drug's Use
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.Posted by at 09:28 AM | Comments (24) | TrackBack (0)
May 19, 2003
Trial lawyers on the prowl
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
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.Posted by at 07:19 AM | Comments (4) | TrackBack (0)
May 16, 2003
IgE blocking drug approved
My quick summary - we have a new asthma drug which should receive approval. Now we need to understand its mechanism, and likely use.
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.Posted by at 07:06 AM | Comments (4) | TrackBack (0)
May 08, 2003
Drugs going OTC and the cost implications
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 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.
This has made the pharmaceutical industry very nervous.
This switch to a potentially activist FDA certainly provides an interesting possibility for investors to consider.Posted by at 08:33 AM | Comments (0) | TrackBack (0)
April 30, 2003
A contrary view on Scully
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
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!Posted by at 11:05 AM | Comments (5) | TrackBack (0)
April 28, 2003
My earlier rant continued -
These practices do not surprise physicians. This article just adds fuel to my fire over the marketing prescription drugs.
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!Posted by at 09:38 PM | Comments (1) | TrackBack (0)
More on the pharmaceutical industry
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 PracticesPosted by at 11:08 AM | Comments (0) | TrackBack (0)
April 27, 2003
More on the FDA and efficacy
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:
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.
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.Posted by at 09:09 AM | Comments (4) | TrackBack (0)
April 26, 2003
The FDA mandate
Robert Prather has a very interesting piece today - Even More Radical Change Needed At The FDA
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
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.Posted by at 08:36 AM | Comments (4) | TrackBack (1)
April 25, 2003
Still more on drug companies
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.Posted by at 07:18 AM | Comments (1) | TrackBack (0)
April 24, 2003
On the pharmaceutical industry
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 .
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.Posted by at 10:11 AM | Comments (5) | TrackBack (1)
April 23, 2003
Can the pharmaceutical companies do good?
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
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.
There, your honor, is the evidence of Pfizer's nefarious plan. Their plan is working, they are evil.
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.
Now I am really confused. Could the drug company program really help patients?
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?Posted by at 05:28 AM | Comments (5) | TrackBack (0)
March 21, 2003
Introducing price into drug benefits
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.
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.
Posted by at 06:41 AM | Comments (0) | TrackBack (0)
March 11, 2003
Just say no to Nexium
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
Bravo!! Bravo!!!Posted by at 10:10 AM | Comments (19) | TrackBack (0)
January 03, 2003
TV drug ads
Well said - When TV Commercials Play the Doctor.
Posted by at 01:00 PM | Comments (2) | TrackBack (0)
December 27, 2002
Generics price rising
This is a disturbing trend which will have a major impact on the cost of health care. Perhaps this trend will stabilize over time.Posted by at 10:33 AM | Comments (1) | TrackBack (0)
December 26, 2002
The Pharmaceutical Industry Fights Back
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.Posted by at 08:52 AM | Comments (3) | TrackBack (0)
December 23, 2002
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.Posted by at 06:23 AM | Comments (125) | TrackBack (0)
December 11, 2002
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.
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.Posted by at 06:33 AM | Comments (5) | TrackBack (0)
December 10, 2002
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!
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.Posted by at 08:47 AM | Comments (6) | TrackBack (0)
December 09, 2002
Problems with DTC advertising
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?
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.Posted by at 05:35 AM | Comments (0) | TrackBack (0)
November 27, 2002
Guest rant on PPIs
A reader sends this rant:
Well stated and accurate. I will repeat - JUST SAY NO TO NEXIUM. AVOID THE NEW PURPLE PILL!Posted by at 06:08 AM | Comments (4) | TrackBack (0)
New osteoporosis drug
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.Posted by at 06:05 AM | Comments (2) | TrackBack (0)
November 18, 2002
Pharmaceutical pipeline slow
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.Posted by at 06:04 AM | Comments (0) | TrackBack (0)
November 01, 2002
Hope for generic Prilosec
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.
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.Posted by at 06:00 AM | Comments (5) | TrackBack (0)
October 29, 2002
Drug company pressure
Posted by at 05:31 AM | Comments (1) | TrackBack (0)
The new cholesterol lowering drug
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.
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.Posted by at 05:00 AM | Comments (95) | TrackBack (0)
October 22, 2002
NY Times on Bush's generic support
Posted by at 06:33 AM | Comments (1) | TrackBack (0)
October 21, 2002
Bush finally acts on generics
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
This is a good start. I hope that we do get some speed on generics release.Posted by at 05:57 AM | Comments (0) | TrackBack (0)
October 14, 2002
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).
AMEN!Posted by at 09:01 AM | Comments (1) | TrackBack (0)
October 09, 2002
Generic drug delays
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).Posted by at 06:37 AM | Comments (0) | TrackBack (0)
The elasticity of drug costs
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.Posted by at 06:10 AM | Comments (0) | TrackBack (0)
October 05, 2002
Raising the price on the poor elderly
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.
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?Posted by at 06:13 AM | Comments (0) | TrackBack (0)
October 02, 2002
Phrma and Congress
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
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.Posted by at 05:49 AM | Comments (1) | TrackBack (0)
October 01, 2002
The government weighs in
Posted by at 05:30 AM | Comments (0) | TrackBack (0)
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).Posted by at 05:17 AM | Comments (0) | TrackBack (0)
September 29, 2002
High drug costs -Caveat emptor
Caveat emptor. But I do understand the buyer's motivation. Medications can cost a lot of money!Posted by at 06:32 AM | Comments (1) | TrackBack (0)
September 24, 2002
The cost of drugs - patient perspectives
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.Posted by at 05:24 AM | Comments (0) | TrackBack (0)
September 21, 2002
Lagniappe has an important article this week. He talks about patent law and the pharmaceutical industry. As Others See Us.
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.Posted by at 11:42 AM | Comments (7) | TrackBack (0)
More troubles for AstraZeneca Posted by at 06:38 AM | Comments (0) | TrackBack (0)
September 16, 2002
Controlling drug costs
Nice article, reprinted from the Wall Street Journal - States, Insurers Find Solutions for Drug Costs describes succesful strategies for decreasing drug costs.
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?
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!Posted by at 07:02 AM | Comments (0) | TrackBack (0)
September 07, 2002
NY Times on Medicaid drug purchasing
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
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.Posted by at 06:48 AM | Comments (0) | TrackBack (0)
September 04, 2002
Another patent fight
The Patent Expiration Fun Continues - nice report by Derek Lowe of Lagniappe.Posted by at 08:37 AM | Comments (0) | TrackBack (0)
September 03, 2002
About the pharmacy protection law
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.
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.Posted by at 05:22 AM | Comments (0) | TrackBack (0)
August 30, 2002
OTC or not
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.Posted by at 06:37 AM | Comments (1) | TrackBack (0)
August 29, 2002
Thoughts on pharmaceutical developments
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.Posted by at 05:48 AM | Comments (1) | TrackBack (0)
More on drug companies and costs
'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.Posted by at 05:35 AM | Comments (0) | TrackBack (0)
August 26, 2002
PhRMA against governors
States Sued For Pushing Cheaper Drugs Via Medicaid . Just when I think about taking it easy on the pharmaceutical industry - there they go again.
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.Posted by at 06:44 AM | Comments (1) | TrackBack (0)
August 24, 2002
More on celebrity drug hawking
Prescription drugs to have and to have not. Read this nice opinion piece about celebrity interviews and the pharmaceutical industry.Posted by at 07:31 AM | Comments (0) | TrackBack (0)
August 23, 2002
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.Posted by at 05:15 AM | Comments (0) | TrackBack (0)
August 22, 2002
OTC Prilosec - one step closer
As indicated last month, we will probably soon have our first over the counter proton pump inhibitor - FDA gives conditional OK to nonprescription Prilosec
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.Posted by at 05:25 AM | Comments (1) | TrackBack (0)
August 18, 2002
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.Posted by at 06:53 AM | Comments (0) | TrackBack (0)
August 16, 2002
Pharmaceutical company lawyers
Read this story from Lagniappe (barf bag not included) - Great Moments in Legal Reasoning. No commentary here - just read the link.Posted by at 06:07 AM | Comments (2) | TrackBack (0)
August 14, 2002
Tobacco and the pharmaceutical industry
Study: Tobacco firms tried to weaken anti-smoking aids. This story stinks so bad, that I may have an anxiety attack.Posted by at 07:04 AM | Comments (1) | TrackBack (0)
August 13, 2002
The new PhRMA rules
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?Posted by at 08:33 PM | Comments (0) | TrackBack (0)
Pharmaceutical companies and celebrities
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?Posted by at 05:42 AM | Comments (0) | TrackBack (0)
August 07, 2002
Drug company rebuked
I hate typing this. FDA Rebukes Maker Of Diet Drug Meridia
Why are they not thinking? What are they trying to hide? This makes me very unhappy.Posted by at 06:08 AM | Comments (2) | TrackBack (0)
August 05, 2002
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 -
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.Posted by at 06:58 PM | Comments (0) | TrackBack (0)
August 02, 2002
The problem defined - many patients cannot afford their medications
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.Posted by at 06:34 AM | Comments (9) | TrackBack (0)
Marketing a disease
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
Posted by at 06:13 AM | Comments (0) | TrackBack (0)
August 01, 2002
More on the pharmaceutical companies
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.Posted by at 02:56 PM | Comments (0) | TrackBack (0)
July 31, 2002
Quicker generic availability
Hopefully, this recommendation will allow faster entry of generics into the market.Posted by at 06:21 AM | Comments (0) | TrackBack (0)
July 29, 2002
Medpundit on drug pricing
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:Posted by at 05:56 AM | Comments (1) | TrackBack (0)
Medicine as fashion
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.Posted by at 05:32 AM | Comments (0) | TrackBack (0)
July 28, 2002
Doing the right efficacy studies
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?Posted by at 06:14 AM | Comments (0) | TrackBack (0)
July 25, 2002
Discourse with Jane Galt
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.Let me respond as best I can. First, Jane is speaking from an economic view, and therefore her use of the phrase irrational must be taken in the economic context. While I understand her economic argument, I (as well as many commentors on her site) disagree with some of her assumptions. In economic discussions, we always have the most fun when arguing the assumptions.
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).Posted by at 06:38 AM | Comments (8) | TrackBack (0)
July 24, 2002
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!Posted by at 08:53 AM | Comments (0) | TrackBack (0)
Arguing over pharmaceutical marketing
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.Posted by at 07:53 AM | Comments (0) | TrackBack (0)
Spin time for a pharmaceutical company
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.
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!Posted by at 04:32 AM | Comments (0) | TrackBack (0)
July 19, 2002
Bloviator comments on drug industry advertising
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!Posted by at 03:59 AM | Comments (0) | TrackBack (0)
July 18, 2002
Cheaper drugs from Canada?
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:
I suspect that we will hear more on this issue.Posted by at 03:09 AM | Comments (4) | TrackBack (0)
More on advertising than research
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.You aren't surprised. We have all seen this especially with the direct to patient advertising. The industry tried to rebut the data.
“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.”
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.Posted by at 03:04 AM | Comments (0) | TrackBack (0)
July 17, 2002
And the jockeying for position begins
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.Bad news for one company could be good news for other companies.
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 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.Posted by at 07:23 AM | Comments (0) | TrackBack (0)
July 16, 2002
My personal crusade against AstraZeneca - just say no to Nexium
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)Posted by at 04:19 PM | Comments (1) | TrackBack (0)
It would be nice if everybody could find a doctor with half the common sense of this one. - Junkyardblog
An academic general internist comments on medical issues and the current state of medicine.
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