Read Overlawyered's take on how physicians are responding to HIPAA. Medical privacy madness, cont'd

... Silly doctors, to be so spooked by the prospect of $10,000 fines for overstepping hundreds of pages of guidelines.

Remember the Match lawsuit. It still looms. This lawsuit claims that the Match artificially suppresses housestaff salaries. But one economist argues against that claim. Harvard economist argues that Match is not anticompetitive

The National Resident Matching Program is not the culprit behind residents' relatively low wages, says Alvin Roth, PhD, a Harvard University economist and author of the Match's mathematical formula that links medical students with residencies.

Dr. Roth argued his perspective, which is contrary to claims made in an ongoing lawsuit against the Match, in an economic analysis in the Sept. 3 issue of the Journal of the American Medical Association. "The scientific hypothesis seems to say matches per se lower wages, and [the economic analysis] seems to say strongly that that hypothesis is false," Dr. Roth said.

In May 2002, three residents filed a lawsuit alleging that the Match artificially depresses resident wages and restrains competition. The plaintiffs are seeking class-action status for all residents in the country.

Dr. Roth and his co-author looked at fellowship salaries to test the premise that abandoning the Match would cause resident salaries to rise. Internal medicine subspecialty programs within the same hospitals were compared. Some of the subspecialty programs participated in the Medical Specialties Matching Program, while others did not.

"Unlike residency training, fellowships are an optional part of a career path," Dr. Roth and his co-author stated. "Thus, potential fellows have market alternatives; fellowship programs must compete not only with other programs, but with less-specialized medical positions, because fellows could practice medicine without pursuing a fellowship."

They found that wages were not significantly different for programs that used the Match compared with those that did not. Fellows had the choice of going into higher-paying practices, but fellowship wages did not rise to make the positions more attractive. This suggests that the matching process is unrelated to the relatively low wages involved, Dr. Roth said.

Lawyers should understand this concept. Many first year lawyers accept low paying clerkship jobs. These jobs pay less for that year, but generally make the lawyer more attractive in the future. These lawyers trade their immediate income for future gains.

Physicians make the same choices. They need some post-graduate training to properly practice their chosen specialty. They often knowingly choose longer training programs (like cardiology rather than general internal medicine) for various reasons. In the short run, they make less money. They generally profit in the long run.

This lawsuit makes no sense to those in academic medicine. Worse than the poor logic is the financial drain that such suits cause.

Litigating class-action lawsuits gets expensive, and with 36 defendants named in the antitrust lawsuit against the National Resident Matching Program, this case should be no exception.

Almost all of the academic medical centers and physician organizations named in the lawsuit have sought their own outside counsel instead of having one law firm represent them as a group. Lawyers associated with the case say more than 90 attorneys are involved.

Once the case moves actively into the discovery phase, legal fees alone could mount to $500,000 a year for the defendants as a group, one attorney estimated.

Frances Miller, a professor at Boston University School of Law, said, "There are so many defendants. Regardless of the outcome, the litigation costs are high even if it never comes to trial."

Read this - you just may not believe it. Oh, that medical privacy

Found this link on Drudge Report! Judge Throws Out Obesity Suit Against McDonalds

In dismissing the current suit, Sweet said that the plaintiffs had not followed his detailed instructions and he barred them from filing another version, quelling litigation fears the suit had sparked in the food industry, .

"The plaintiffs have made no explicit allegations that they witnessed any particular deceptive advertisement and they have not provided McDonald's with enough information to determine whether its products are the cause of the alleged injuries," Sweet said.

"Finally, the one advertisement which plaintiffs implicitly allege to have caused their injuries is objectively non-deceptive," he said.

I suspect more articles about this ruling tomorrow. This is a victory for commonsense!

Overlawyered has collected the information. Go over to his blog and read all about it - "Public balks at obesity lawsuits"

McLawsuits

As silly as it is, the coming legal assault on junk food was predictable. The tobacco victories, which followed big scores in asbestos and breast implants, have made the trial lawyers richer and more cocksure than ever. The profession seems incapable of policing its own, and the result has been an explosion of self-interested legal entrepreneurs masquerading as public servants. The politicians, particularly Democrats, have done little to advance the cause of tort reform, lest they clog a major artery of campaign contributions. What distinguishes this latest class-action money grab, however, is that, at bottom, it's a bald assault on the public's intelligence.

The case against the food industry--broadly defined by opponents to include everyone from farmers and retailers to advertisers and restaurant owners--ultimately rests on the assumption that overweight Americans are too weak-willed or too stupid to resist food marketing. Hence Prof. Banzhaf's pep rally was preceded and followed by presentations from a dozen or so other activists with tenure, all attempting to separate obesity from individual responsibility.

Prof. James Hyde of Tufts University told the audience the idea that a healthy lifestyle is a matter of personal choice is a common myth. "The reality," he continued, "is that healthy behavior is often dictated by factors completely outside the individual's control." Prof. Marion Nestle of New York University--she's quick to note that her name is pronounced NES-uhl--said that obesity is the result of America's food supply being too plentiful and too cheap, and that "deliberate federal policies make this so." Ben Kelley, who heads the Public Health Advocacy Institute, which sponsored the conference, said he simply wants "to help the many who can't resist the blandishments of the marketplace."

Others couldn't resist dragging their sundry liberal political causes into the mix. After calculating that obesity-related illnesses cost the U.S. up to $50 billion annually, Prof. Aviva Must of Tufts University remarked, "That's a lot, even for very wealthy countries that have a lot of money to spend on things like war." Michael Jacobson of the Center for Science in the Public Interest said the federal government isn't spending enough on the problem because "the Republicans' $400 billion federal deficit will not allow for such things." Stephen Joseph, the San Francisco trial lawyer who filed (and later dropped) a suit to ban Oreo cookies, warned that "male conservative Republican right-wing elements" are the biggest opponents of this litigation. "They're more worried about freedom," he said. "They don't care about kids."

So they paint a bleak picture. The problem with laws and lawyers comes when they twist meanings and intent solely to seek out deep pockets.

The Personal Responsibility in Food Consumption Act, recently introduced by Rep. Ric Keller, a Florida Republican, would quash much of this nonsense pronto. But like all tort-reform legislation approved by the House--a similar bill banning frivolous suits against gun manufacturers passed earlier this year--the measure is likely to stall in the Senate unless Republicans can muster a filibuster-proof majority. In the meantime, says Walter Olson of Overlawyered.com, we can only hope that "a fit of sense will descend on the judiciary and the press, and that this will all be laughed off the national stage eventually."

While I blog about medicine 99% of the time, I cannot resist this link. Zell Miller has nailed this one. Living most of my life in Virginia (growing up in the mountains of Southwest Virginia), and Alabama, I understand Senator Miller's points. For us Southerners this is a hot button issue. Stereotyping, That Is Mr. Moonves, call off your hillbilly hunt.

Lawyers revise obesity lawsuit against McDonald's

In the revised complaint, attorney Samuel Hirsch accused McDonald's of "deceptive practices in the advertising, processing and sale of foods, including Chicken McNuggets, Filet-O-Fish, Chicken Sandwich, french fries and hamburgers."
Hirsch asked for class-action status for the suit on behalf of "hundreds of thousands of New York state residents under the age of 18" who suffer health problems as a result of eating McDonald's food.

In the 46-page complaint, Hirsch alleged that McDonald's does not make its nutritional information "adequately available" and said numerous claims made by the fast-food chain are misleading and untrue.

While a McDonald's nutritional booklet claims the fish in a Filet-O-Fish is "100 percent cod with a pinch of salt to taste after cooking," the list of ingredients for the sandwich includes modified corn starch, dextrose, cellulose gum, citric acid and an anti-foaming agent called dimethylpolysiloxane, the complaint alleges.

The suit also alleges that while McDonald's claimed in advertisements that its beef is nutritious and leaner than beef purchased in a supermarket, the levels of saturated fat and cholesterol would not make the beef nutritious. The United States Department of Agriculture has also found that meat used in fast-food outlets was generally fattier than retail meat purchased in grocery stores, the complaint said.

In a statement McDonald's called the new lawsuit "senseless" and accused the plaintiffs of "focusing on only one food organization."

I can only ask why. These lawsuits give the legal profession a bad reputation. They do not address the underlying problem. Parents must take responsibility for teaching their children good eating habits. Why does our culture allow such suits?

A Court Expands the Rights of Patients to Sue H.M.O.'s

A federal appeals court has expanded patients' rights, ruling that consumers can sue a health insurance company for injuries resulting from the company's refusal to authorize medically necessary treatment.

The ruling, issued last week by the United States Court of Appeals for the Second Circuit, in New York, said that health maintenance organizations and their medical directors could be sued for medical malpractice when they made decisions about the treatment of a patient.

In the past, courts have often rejected such claims, saying they were precluded by the federal law on employee benefits. But the appeals court said those precedents were no longer binding because the Supreme Court had established a new framework for analyzing the issue in a 2000 case, Pegram v. Herdrich.

The Supreme Court held then that some decisions involved both an interpretation of an insurance contract and the exercise of medical judgment about how to diagnose and treat a patient's symptoms. The appeals court said H.M.O.'s could be held accountable for such "mixed eligibility and treatment decisions" under state standards of medical malpractice.

While I always have mixed feelings when the legal system gets involved, I applaud this decision. Insurers have put physicians in an awkward position. We cannot just recommend the best therapy, rather we must ask permission. Patients do need some protection from insurers and medical directors. How do we achieve the appropriate balance between cost and efficacy?

This decision (and the problem it addresses) raises a very important problem in health care. How do we proceed once we admit that we have limited resources? Who makes the decisions about rationing health care? And make no mistake, all systems eventually will lead to rationing. We are very uncomfortable with the thought of rationing, yet to not ration means ever increasing costs which our society will not willing pay.

As I wrote earlier this week, the judge threw out the McDonald's obesity lawsuit. Your Honor, We Call Our Next Witness: McFrankenstein. For those who are interested in the details of the opinion, this article provides sufficient depth. As I noted previously, the judge did leave the door partially open.

Big Macs Can Make You Fat? No Kidding, a Judge Rules

The suit, which had not reached trial, sought class-action status on behalf of potentially millions of children and teenagers who buy McDonald's hamburgers, French fries and other products. The suit accused the fast-food chain of deceiving consumers about the high levels of fat, sugar, salt and cholesterol in its products.
The judge, Robert W. Sweet of Federal District Court, said there was no evidence that McDonald's had concealed information about its ingredients, and he said it was widely known that fast food, and McDonald's products in particular, contained high levels of such potentially harmful ingredients.

"If a person knows or should know that eating copious orders of supersized McDonald's products is unhealthy and may result in weight gain," Judge Sweet wrote, "it is not the place of the law to protect them from their own excesses."

He added wryly: "Nobody is forced to eat at McDonald's.

I could not have said it better. Unfortunately, as judges often do, he did leave a crack in the door - and we know that lawyers love cracks.

Their lawyer, Samuel Hirsch, said the court had given the case a fair hearing. He added that he intended to file an amended suit in line with one aspect of the ruling, in which Judge Sweet suggested one avenue by which such a suit might be pursued.
The judge said that such a complaint could accuse McDonald's of altering its food during processing, thus creating an "entirely different ? and more dangerous ? food than one would expect" at home or in a restaurant other than McDonald's.
The judge noted, for example, that Chicken McNuggets, rather than being merely chicken fried in a pan, are what he called "a McFrankenstein creation of various elements not utilized by the home cook."

Such an argument, the judge added, "may establish that the dangers of McDonald's products were not commonly well-known, and thus that McDonald's had a duty toward its customers."

McDonald's argued that it was known that processing food can make it more harmful. The judge did not say how he might rule on such an allegation.

So now they must be searching for a fat kid who lives on Chicken McNuggets. That kid is out there. Get ready for the bulletin boards advertising - Are you Fat? Do you eat Chicken McNuggets every day? Do we have a case for you!

High Court Considers Drug Pricing Plan

If the court signs off on an experimental program in Maine, other states would soon try the same thing, lawyers said. The court was hearing arguments Wednesday in an appeal brought by drug companies that claim the state overstepped its legal and constitutional bounds.

The Maine program, known as Maine Rx, would try to force drug companies to negotiate lower drug prices with the state, which would then offer the savings to the uninsured. The state estimates it would help more than 300,000 people who do not have prescription drug coverage.

If prices didn't drop in three years, the state could impose price controls.

Twenty-eight states are backing Maine, and about a dozen are poised to pass similar laws quickly if the Supreme Court sides with the state.

Business groups and conservative legal organizations sided with the drug industry, which lost a lower-court attempt to overturn the 2000 law. The law is on hold pending the drug companies' appeal.

The issue for the Supreme Court is whether the Constitution and the federal Medicaid law allow such freelancing by state governments. The Pharmaceutical Research and Manufacturers of America contends the state program violates Medicaid law and is an unconstitutional regulation of interstate commerce.

Very interesting question posed here. Certainly, we have a huge problem to solve. I like this solution, however, I wonder if this would hinder research. Not really understanding the economics, I cannot comment.

Congress weighs bill to stop Medicare 4.4% pay cut

A bill introduced by Rep. Bill Thomas (R, Calif.) on the first day of the 108th Congress would halt implementation of the physician fee schedule rule -- including the pay reduction -- released by the Bush administration in late December.

"One of the biggest problems is that physicians face significant and successive payment cuts that could harm patients' access to care," Thomas said. "Our newest legislation would block the 4.4% cut from taking effect."

The measure would rely on an infrequently used mechanism that allows Congress to overturn regulations issued by federal agencies within 60 days of publication. The Congressional Review Act limits debate in the Senate to 10 hours and bans filibusters.

The House approved a bill last year that would have replaced the 2003 cut with a 1.9% increase. The Senate, however, was unable to pass the measure as key lawmakers, including Sen. Charles Grassley (R, Iowa), balked at offering a bailout for physicians without including funds for other health care groups.

Grassley, who is now chair of the Senate Finance Committee, has objected to the Thomas bill this year because it would set aside other provisions contained within the physician fee schedule rule. Grassley is trying to broker an alternative approach in the Senate that would maintain physician payments at 2002 levels and provide some limited relief for rural hospitals.

This demonstrates the problem with our political system. Take an issue with general agreement and Senators will always try to attach another provision. I agree with finding relief for rural hospitals. But that is a different issue and should be a different bill.

"Physicians have already taken a 5.4% cut in 2002," Dr. Coble said. "If Congress doesn't act by March 1, physicians will take cumulative payment cuts of 10% for treating our nation's seniors and disabled, with more cuts to come."

Dr. Coble said there was widespread agreement in Washington that the cuts resulted from a mistake in calculations and should have been fixed long ago.

Many physician practices already have decided to limit the number of new Medicare patients they will take, while others are contemplating a change to nonparticipating status this year. That would allow them to make up for the shortfall in government payments by billing their Medicare patients more.

And advocates cannot understand why physicians fear universal health plans. They would have to orginate with Congress. And we do not trust them to [1] pass the right bills or [2] correct their mistakes. Maybe we should just sue them for malpractice!

Stories like this one are pushing me to start a new blog titled - Unintended Consequences. Trial lawyers, special interests and vaccines

Since early November, when the homeland security bill was being debated in the Senate, Mrs. Stabenow and many of her Democratic colleagues on Capitol Hill have denounced the vaccine language as a special-interest measure benefiting big drug companies that would "severely limit parents' ability to get justice for their children." Mrs. Stabenow accused advocates of the vaccine measure of seeking "to reward powerful special interests under the guise of homeland security."

But these assertions by Mrs. Stabenow, (who according to the Web site opensecrets.org received $474,412 from trial lawyers during her 2000 Senate campaign, the seventh-highest total received by senators that year), stand the truth on its head. Her proposal, which will be voted on in the Senate in coming weeks, will hardly make Americans safer. Instead, it could well jeopardize public health and homeland security by making it less likely that essential, lifesaving vaccines ? including vaccines against diseases caused by chemical or biological weapons ? ever make it to market.

Victor Schwartz, a veteran Washington lawyer who serves as general counsel for the American Tort Reform Association, points out that Congress, with the support of liberals such as Rep. Henry Waxman, California Democrat, instituted the no-fault vaccine injury compensation program in the mid-1980s to provide a quick alternative to enable individuals to receive compensation when they are injured by a vaccine. Mr. Schwartz, who was involved in drafting that legislation, says that Congress always intended the program to cover ingredients along with the vaccines themselves. The provision of last year's homeland security legislation (which was added in response to trial lawyers' efforts to create an artificial distinction between vaccines and their ingredients) was nothing more than an effort to clarify this point.

What's more, the provision didn't take away anyone's right to sue. Instead, it allows people injured by vaccines and their ingredients the chance to quickly recover damages for their injuries from a compensation fund paid for by manufacturers. "Most people agree to a settlement through this fund, but if they are not satisfied with their award, they can then choose to file a civil lawsuit," Mr. Schwartz says.

By contrast, the Stabenow approach will effectively guarantee that, unless a vaccine ingredient works perfectly and without adverse side effects in every person who receives it ? an impossible standard to meet ? that the manufacturer could face a multimillion-dollar lawsuit. This will make it far less likely that vaccines, including ones that could protect Americans in the event of deadly attacks using chemical or biological weapons, will ever be produced. Already, the number of foreign and domestic vaccine producers has declined from roughly 24 in 1967 to just four today.

Several thoughts come to mind here. First, I continue to think of the parable about the goose and the golden egg. Second, I recall Robert Burns

But, Mousie, thou art no thy lane
In proving foresight may be vain:
The best laid schemes o' mice an' men
Gang aft a-gley,
An' lea'e us nought but grief an' pain,
For promised joy.

For the entire poem - Robert Burns To a Mouse Maybe I should name the blog - Unintended Consequence - the best laid plans.

Diet Dispute

U.K.-based psychotherapist Susie Orbach, author of Fat Is A Feminist Issue, is planning a lawsuit against Weight Watchers on behalf of what she says are thousands of women and men who have paid out many hundreds of British pounds to the company, only to end up fatter than before they started the program. Orbach's main argument: diets simply don't work, and the dieting industry profits from the large number of people who come back to the program after they gain the weight back.

"I believe that it is the very 'problem' of recidivism that has made Weight Watchers its fortune," wrote Orbach in an editorial in London's Daily Mail last month.

Orbach has claimed that nine out of 10 Weight Watchers graduates fail to keep off the pounds they've lost, a figure the company disputes.

This really does not need extensive comment, but I do have one thought related to all these victimization suits. I am a fan of Stephen Covey's "7 Habits of Highly Effective People". I have read the book several times, and also periodically listen to the audiotapes. Currently, I am listening to the 1.5 hour version. Yesterday I spent time listening to and thinking about Habit 1

Proactivity

Being proactive means taking initiative, not waiting for others to act first, and being responsible for what you do. The opposite of proactive is reactive. Reactive people react to what goes on around them. Proactive people act based on principles.

Few people in our world take responsibiltiy for their outcomes. They blame others rather than understand how they can succeed. They may take credit for weight loss success, but weight gain occurs because McDonald's tastes too good or Weight Watchers is ineffective. As long as our society rewards and supports this victimization role, we will have stupid law suits.

Admittedly, some people have greater difficulty with weight gain than others. Most people can succeed by changing their eating habits (especially portion control) and their exercise habits. Ones inability to succeed should compel one to reconsider the failure and understand how one can change to achieve success. Unfortunately, few have that strength of character. And character matters.

In the absence of responsibility and character, we are quick to blame (and apparently quick to sue). We should not accept such actions. We should restore the importance of responsibility and character to our society.

Obesity on trial Restaurants, food firms: Lawsuits wrongly blame their food

Alan Milstein is at it again. I previously have written about this lawsuit. Today's Washington Post lays out the case in more detail. Artificial Heart Implant Leads to Suit Over Consent Process: Recipient's Widow Says She and Her Husband Were Misinformed and Misled on Risks, Benefits This article is worth reading in its entirety. The challenge here is an interesting one. Despite a detailed informed consent document AND a patient advocate to explain the details, the surviving wife claims she and her husband did not understand.

"I figured it was like a regular heart," Irene Quinn said last week. "You get it, and we come home and do the things we normally do."

Instead, she said, after a remarkably promising recovery in the weeks after the surgery, her husband suffered complications and setbacks over the next nine months before suffering a massive stroke Aug. 23. Three days later, after Quinn had been declared brain dead, Louis E. Samuels, the surgeon who implanted the heart in Quinn, was at his side when the heart was turned off.

"He would have been better off dead," Irene Quinn said of her husband and her experience with the artificial heart. "There was no quality of life. It was too painful. He said he wished he'd never done it."

So who gets sued, the manufacturer, or the surgeon, or the patient advocate?

Now, Irene Quinn is suing Abiomed Inc., the maker of the AbioCor artificial heart; Hahnemann University Hospital, its parent company and affiliated medical school; and the patient advocate assigned to help the Quinns understand the consent process. She claims they were misinformed and misled about the risks and benefits of the procedure and the potential for pain and suffering.

"The informed-consent process failed," said Alan Milstein, Quinn's attorney, who has represented plaintiffs in other cases involving clinical trials. "They didn't understand what it meant to volunteer for a human subject experiment. They thought this was his only chance, that it was a therapeutic option, and not that he was a human guinea pig."

Note the use of language here - 'a human guinea pig'. These words are carefully chosen to invoke an image of mean scientists doing things to patients. These words are like cursing to medical researchers. Note that they are not suing the surgeon!

In setting up the trial, Abiomed, the Danvers, Mass., firm that makes the AbioCor heart, took steps beyond those required to help families make informed choices about participating. The company set up a trust establishing an independent patient advocacy council to provide advocates not affiliated with any of the trial sponsors to help patients understand the informed-consent process. The advocates typically have medical training and are experienced in end-of-life issues and medical ethics.

"What's new here is that a commercial organization has hired a person experienced in patient care and ethics to serve as an advocate for each patient," said Robert A. Levine, Yale University professor of medicine and bioethics.

"We believe it's the most progressive practical model yet devised to protect patients in high-stakes clinical trials," said Abiomed Vice President Edward E. Berger. "We're very proud of the effort that was made by the clinical staff at Hahnemann Hospital and by the original patient advocate to assure well-informed decision making. We do intend to defend against this lawsuit very vigorously."

The Quinns' advocate, David Casarett, a bioethicist and geriatrics specialist at the University of Pennsylvania, is being sued by Irene Quinn. But notably absent from the lawsuit is Samuels, with whom the Quinns had grown close and who, ultimately, was the person responsible for ensuring they were fully informed and getting them to sign the consent document. Neither Casarett nor Samuels would comment on the case.

We all know that informed consent is a dangerous phrase. Can patients really understand the consent process? Patients hear what they want to here and ignore what they want to ignore. One could argue that no informed consent process is ever satisfactory. We can always find flaws when we use the retrospectoscope.

I feel badly for Mrs. Quinn, but I do not believe she should have sued. I do not believe that Mr. Milstein should have taken this case. The company clearly went to great lengths to insure informed consent. If this case succeeds how much damage will occur to good science. What are the risks and benefits of persuing this case?

These overarching questions never seem to matter in such cases. Sometimes we should consider the good of future patients and investigation. This study is important, well conceived and well done. I hope the lawsuit is 'thrown out'.

A Chill on Patients' Trust

The investigation into the coronary-care unit and Medicare payments it generates for the Redding hospital is just part of the story. Red flags appeared late in October after a Wall Street health-care analyst questioned the overall heavy reliance on Medicare payments at Tenet, one of the nation's largest hospital companies.

The federal Department of Health and Human Services then said it would audit Tenet's receipt nationwide of special Medicare payments that are designed to help hospitals defray financial losses from difficult and invasive procedures. Worried investors quickly fled, Tenet's share price took an abrupt nose dive and the company's chief operating and chief financial officers unexpectedly resigned.

Patients can't help worrying about collisions between medicine and profit, because their very lives are at stake.

It's bad enough to think of doctors performing unnecessary procedures for their own gain. It's even worse if the push for profits could combine with a poorly designed and badly monitored Medicare payment program to create an environment that encourages fraud or gaming the system.

The tension between income and medical recommendations affects physicians and patients alike. Whether the physician makes recommendations that would benefit him/her financially, or the insurance company refuses to pay for investigations or therapy, the problems of money plague our system. I wish I knew a better system. A one payor system still has financial problems.

Snack Attack: After Taking On Big Tobacco, Social Reformer Jabs at a New Target: Big Fat.

Oh, it's important to be on the right side and all, but what really gets John Banzhaf going is being on the short side of a long-odds fight. He likes to position himself as a little fellow with a pickax, digging away at social ills and wrongheaded industries. He did it with tobacco for 35 years, arguing for nonsmoker's rights, helping eliminate cigarette advertising on television, helping establish nonsmoking sections in public places and smoking bans on planes, trains and buses.

Now, he wants to sue for obesity.

The public, he allows, may not quite be ready for this; they may find the notion downright "bizarre." But they'll come around. After all, this is about "using legal action for what seems to me very important," says Banzhaf, an unflappable, roly-poly law professor at George Washington University. "Saving human lives."

It's too bad it has to be this way, Banzhaf says, but when legislators don't step up to the plate, the lawyers have to push for social reform. So, in the past, for causes ranging from discrimination to preventing a tobacco-sponsored tournament, he has sued Hertz, Spiro Agnew and the Interstate Commerce Commission, filed legal complaints against dry cleaners, male-only clubs, the National Park Service, Rep. Barney Frank and Mrs. Simpson's Dance Classes, threatened Dulles Airport, and delivered a Freedom of Information Act to the Office of the President. Sue 'em all!

This guy is a pest. You would hate to have him coming after you.

The way John Banzhaf sees the obesity lawsuits, they're just the latest in his lifelong effort toward "pushing the boundaries." He says he has nothing personal against the food industry; in fact, he used to eat in fast-food joints several times a week. He says he will make no money from the New York litigation.

No, it's nothing personal. It's about personality. On Banzhaf's Web site, he boasts of having been called a "legal terrorist." He has built a public persona on this principle, for decades teaching a legal activism course that encourages law students to bring to court social reform lawsuits. His favorite saying -- "Sue the bastards" -- has been linked to him so many times, it's downright trite to bring it up. The saying is on his office wall, and also on his office wall in Latin. His license plate says SUE BAST.

Needless to say, certain people rather dislike him.

"He is the loudest and most relentless voice," says John Doyle of the Center for Consumer Freedom, a Washington-based restaurant trade association, who finds Banzhaf a little, um, shrill and likes to tell about the time he says a radio station had to turn off Banzhaf's mike to shut him up. (Banzhaf doesn't remember it that way.)

If you ask Doyle -- and indeed, some of the very same lawyers who pushed for Big Tobacco litigation along with Banzhaf -- the problem with suing Big Fat is that it ignores the consumer's free will.

So we can expect a long semi-coordinated effort to harass restaurants, food manufacturers, soft drink companies, etc. The challenge for this legal attack is to separate the free will argument from the seduction of the fast food industry.

Is public opinion changing?

For the time being, the weight of it does not appear to fall on Banzhaf's side. Samuel Hirsch's first obesity suit involved the 270-pound maintenance supervisor Caesar Barber, whose capacity to elicit sympathy was questionable. Barber kept eating fast food even after a heart attack and the warning of a doctor. Hirsch has since decided to put Barber's suit on hold because he thinks it may be tough to bring for a variety of reasons.

Anyway, when Hirsch, Barber and Roberta Pelman (mother of an overweight girl in the second suit) appeared on the Dr. Phil show in September, they got . . . perhaps the best word is creamed.

Dr. Phil McGraw: Did you choose the food?

Pelman: Yes, I did.

McGraw: And did you serve it to your child?

Pelman: Yes, I did.

McGraw: So she could sue you for putting it in front of her?

Pelman: Well, you know . . .

Hirsch: Yes, she could.

McGraw: Okay. Anyway. Next, a grown man who makes his own decisions and also blames fast-food chains for his super size.

Reactions like this are why Banzhaf's efforts have as much a public relations goal as a legal one. One hopeful scenario is that, as more information about the food industry comes to light, companies will be shamed into changing their ways, or into settling cases instead of taking them to trial.

I doubt that this campaign will have the success of the tobacco campaign. Food is not addictive, one has choices. One can go to fast food restaurants and not get fat. I doubt that the public will buy into the arguments.

I will put a positive spin on the legal action though. The publicity of the lawsuits will get consumers to think about what they are eating (I hope). We do need a culture change concerning food and exercise. If the suits stimulate that in any way then we will have a minor victory.

A Win for Medical Marijuana

A federal appeals court in California this week struck an important blow for medical marijuana, and for the First Amendment. It held that the government cannot revoke the licenses of doctors who recommend marijuana to their patients. The federal government should now abandon its misguided policy of targeting doctors and sick people to fight marijuana use.

...

The decision, in addition to vindicating the speech rights of doctors and patients, should prompt federal and state governments to reconsider their policies on medical marijuana. The war on drugs surely has better targets than cancer patients and terminally ill people who use marijuana, on the advice of doctors, to reduce their pain.

We teach palliative care on our wards. Our underlying philosophy states that the dying patient should not suffer if we can provide relief. If marijuana can provide relief to the dying patient then we are obliged to not just recommend it, but to fight for the patient's right to use it. This is an ethical and moral judgement on my part. We do not care how much narcotics we prescribe for the terminal patient having pain. Addiction is not a question, death with dignity (dignity for both the patient and the family) is the answer. We need every possible tool to help patients. I am glad the courts understand.

EDITORIAL: Safety for Research Subjects (The government must ensure better protection of human guinea pigs used in the development of drugs that defend against biological and chemical weapons.)

George Painter is the president of a San Diego-based biotech start-up called Chimerix that hopes to develop a pill to combat smallpox. Capitalists, he notes, often fail to invest in companies tackling such important goals because they fear prohibitively expensive pain-and-suffering lawsuits.

The government needs to confront that obstacle. But first Congress and the Bush administration must fix obvious flaws in the Common Rule. That 1991 law lays out guidelines for research on human subjects, but only for publicly funded research conducted by 17 federal agencies. Inexcusably, institutions not receiving federal funds need not comply with any of the safeguards in the rule.

Legislators can find at least two sensible blueprints for reform. One is a 1995 report by a federal task force that suggested expanding protections to even classified research, "requiring the informed consent of all human subjects." Another is a 2001 report from the National Bioethics Advisory Commission recommending that the Common Rule be applied without exception to "all government agencies, academe and the private sector."

There is no reason why Washington can't encourage more private investment in anti-terrorism research while demanding that scientists fully inform and offer strong protections to every human guinea pig who heroically volunteers to test lifesaving chemical and bioterrorism antidotes.

This is a very serious issue. Our research enterprise is threatened by lawyers (what a surprise). We need better guidelines and better protection from opportunistic lawsuits.

Mayor Bloomberg is trying to outlaw public smoking in NYC. The Smoke Nazis

Mr. Bloomberg has framed the smoking ban as strictly an issue of workplace safety — a line that is hard to assail on the merits. The mayor will tell you he strongly defends your right to smoke yourself to death, but you may not spray your toxic effluent into the airspace of innocent bystanders, in particular the waiters and bartenders whose only recourse is to quit their jobs.

There are basically three arguments being raised against him: science, economics and personal liberty. Two of them Mr. Bloomberg wins hands down, and one is open to debate.

This opinion piece nicely dissects the issues - worthwhile reading.

Recently I wrote about Alan Milstein. He gave grand rounds at UAB concerning the rights of subjects in medical studies. He seems to really believe that he is saving the world. He is wrong. Check out this case - Lawsuit Over Artificial Heart. I am struck by Milstein's audacity in this case. You offer a dying man a clearly experimental treatment and then complain that his quality of life was poor after receiving the artificial heart. Does this bother you as much as it bothers me?

Can you afford to care for Medicare patients? Are you reimbursed enough to even break even? Medicare Cuts May Scare Off Doctors

With Medicare scheduled to cut billions of dollars from doctors' payments, a group representing physicians is urging Congress to restore the money before elderly patients have trouble finding doctors.

Unless Congress acts by Nov. 1, "more physicians will be forced to make the difficult decision to stop taking new Medicare patients into their practices," said Dr. Donald Palmisano, president-elect of the American Medical Association. The next round of cuts, which take effect Jan. 1, will be announced next month.

Palmisano said doctors have already taken a 5.4 percent cut and are facing another 12 percent in cuts, equaling about $11 billion, over the next three years. At the current rate of cuts and inflation, Medicare doctor payments in 2005 will be below the 1991 level, Palmisano said.

I am a broken record. We have a health care crisis. It is getting worse. There are no easy solutions.

Medical marijuana users sue U.S. over arrests.

Two of the plaintiffs, Angel McClary Raich and Diane Monson, are patients with serious medical conditions who have obtained recommendations from their doctors to use marijuana to relieve some of their symptoms. The two unnamed co-plaintiffs are marijuana growers who supply McClary Raich with the two ounces of pot she says she needs each week to alleviate her suffering.

Named as defendants in the lawsuit are the U.S. Attorney General John Ashcroft and Asa Hutchinson, administrator of the Drug Enforcement Administration.

The lawsuit is the second time attorney Robert Raich has tried to bring the issue to the U.S. Supreme Court. A year ago, the Supreme Court ruled against his client, the Oakland Cannabis Buyers Club, in its claim that medical necessity overrides federal law. This time, Raich has broadened his argument while narrowing the number of plaintiffs.

The lawsuit contends the four plaintiffs grow their own marijuana solely for their own medical use within the borders of California, thus removing any federal authority under interstate commerce laws. The suit also claims constitutional protection under clauses guaranteeing state sovereignty and due process.

If granted, the injunction would prevent the arrest and seizure of property -- including marijuana -- of only the four defendants, but Raich predicts it will serve as a precedent for the entire country.

"This case obviously involves only the four plaintiffs who brought the case. However, it would then lay a template for any other similarly situated seriously ill patient, in California or any other state with a medical cannabis law," he said.

States's rights versus federal control is not a new argument in our country. If one could show a significant medical benefit to cannabis, why should the federal government legislate against the drug. I do believe that this should become a medical care issue, rather than a legislative issue.

Should the FDA ban ephedra products? This Senator thinks so. Experts, Senator Criticize Ephedra

Kudos to Medpundit - she has summarized the issues in the HMO class action suit beautifully - Doctors and Insurance Companies. The Bloviator has challenged us with a number of strawmen arguments - HOUSE CLEANING. I understand his point, but I think he is guilty of hyperbole. Many malpractice cases are faulty. Physicians do not receive a jury of their peers. Physicians are doing a better job of self policing every year. We continuously work on improving that. However, when we try to police ourselves, guess who enters the picture - yep, lawyers. Restricting a physicians practice often leads to law suits. Surprise!

The purpose of the HMO suit is to get one party (the insurance companies) to treat the other party (physicians) fairly under the contracts the physicians have signed. Dirty HMO tricks cause all the problems that Medpundit describes. If it takes a class action suit to get everyone's attention, so be it. Patients are suffering because of the HMOs - and that is not hyperbole.

The other day I castigated the Democrats over malpractice and trial lawyer support. Today the Republicans land in my doghouse. Give Consumers a Break; Pass Schumer Drug Bill.

Republicans fancy themselves champions of the free market. So why can't Democrats in Washington get the Republican-controlled House to vote on a bill to speed generic drugs into the marketplace?

The bill would increase competition and drive drug prices down by closing loopholes that allow drug companies to use lawsuits and sweetheart deals to extend their right to exclusively market drugs after their patents have expired. Consumers pay for that exclusivity. Patented drugs cost about 60 percent more than their generic equivalents.

The Senate passed the generics bill, sponsored by Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.), with bipartisan support. The nonpartisan Congressional Budget Office says that if it became law, consumers would save $60 billion in drug costs over 10 years. But the Republican House leadership has refused to bring the bill to the floor.

On different issues, both parties make bad decisions.

California Jury Allots Damages of $28 Billion to Ill Smoker. While I do not really like the cigarette companies, this is a bit 'over the top'.

HMOs' Shell Game to Avoid Paying Doctors Hurts the Patients: Health care suffers as practitioners scramble to stay afloat financially. The author of this commentary is the chief of cardiology at UCSF. He summarizes the reasons behind the class action lawsuit against the HMOs.

In frustration, doctors and several state medical associations have turned to the courts for relief. The result is a landmark case being pressed against some of the nation's largest for-profit HMOs. The managed-care industry suffered a major setback last week when the Miami federal judge overseeing the case certified the doctors' suit as a class action.

If you and I don't pay our insurance bills, in full and on time, we're cut off.

It's time that HMOs are required to meet the same standards as the rest of us.

The entire commentary is well written, and at times chilling. I hate that physicians have to use the court system to solve this problem. But I hate the shenanigans of the HMOs more.

So the states sued the big tobacco companies, getting a huge settlement. Have they used the money to help patients or decrease smoking? Most anti-tobacco money diverted: Tobacco-producing states invest little in cessation programs

Under a landmark 1998 legal settlement, the tobacco industry agreed to pay the 46 states $206 billion over 25 years to compensate for the costs of smoking.

Although states could spend the money however they chose, the hope was that much of the cash would be used to follow the example of California and Massachusetts, where powerful anti-tobacco campaigns have yielded sharp declines in smoking.

Instead, only 6 percent of the money states received in 2001 went to tobacco control programs, according to a study published in Thursday’s “New England Journal of Medicine”.

I should be outraged, but actually I am not surprised. If one keeps one's expectations of politicians very low, one is seldom surprised.

Governor, Sign Laura's Law: Interest groups are bringing pressure to bear against an important mental health bill.

By press time Friday night, Gov. Gray Davis still had not signed "Laura's law," an important bill that would let judges order outpatient treatment for seriously mentally ill people who can't fathom the gravity of their condition.

The deadline is midnight Monday.

Davis had pledged to do everything in his power to protect Californians from crime, so supporters of the bill had expected him to embrace the measure. It would enable some of California's most vulnerable people, including many who live on sidewalks or alongside freeways, to get help before they harm themselves or others. But opponents of the legislation have grown particularly vocal in recent weeks.

Two weeks ago, for instance, a subgroup of the Church of Scientology, which opposes virtually all psychiatric treatments, sponsored a rally at the Capitol against Laura's law--named after a 19-year-old killed by a man whose mental illness had been left untreated.

Davis also might be concerned about a recent report from the Judicial Council, a rule-making body for California's courts, which concluded that the bill could be a financial drain on the state.

But the council's analysis overlooks a broad array of information. For instance, it does not consider that the bill's implementation would result in fewer criminal prosecutions of nuisance crimes and more serious offenses, fewer probation violation hearings and fewer sentences of persons with severe mental illness to jails and prisons.

I believe this law is needed - not just in California, but elsewhere. We do see patients who need treatment. When we emptied the 'mental institutions', we did not do everyone a favor. Too many schizophrenics become homeless and even a danger to society. The challenge for medicine and government is balancing individual rights with society needs. This law makes sense.

This editorial addresses a bill concerning making clean needles and syringes available for drug addicts. The author makes a persuasive argument

In a bipartisan vote, the California Legislature passed SB1785, which permits pharmacists to sell up to 30 needles to an adult without a prescription. The bill requires participating pharmacists to provide information about disease prevention and drug treatment to consumers (including a number to call where they can get help) and it mandates pharmacists to participate in syringe-disposal programs.

Some fear that SB1785 condones drug use. But the facts demonstrate the contrary. Numerous studies show that expanding access to sterile syringes reduces disease transmission without increasing drug use, drug injection or crime. This legislation is not about enabling or encouraging drug use -- it is about preserving the lives of Californians.

While I do not personally know the data, I would argue that if the data support this editorial, then the legislature is right and the Governor should sign the bill. Needles next phase in fight against HIV/AIDS This is a public health, not a moral issue.

Why I'm Fighting Federal Drug Laws From City Hall. This opinion piece from the mayor of Santa Cruz highlights an issue I addressed earlier this week.

Before the morning raid, Santa Cruz had a good relationship with drug enforcement officials. Santa Cruz, like many communities, has a problem with illegal drugs, most notably heroin and methamphetamine. In the last 15 months, the D.E.A. has conducted two operations here; working with the sheriff's office and the Santa Cruz Police Department, the agency has caught hundreds of drug dealers and users. According to our police chief, "the D.E.A. did an excellent job" in these operations.

That was not the case on Sept. 5. The D.E.A. came to town unannounced and under cover of darkness.

I'm worried that the agency is going to be coming to other towns, too. Since 1996, eight other states — Alaska, Washington, Oregon, Nevada, Arizona, Hawaii, Colorado and Maine — have passed laws allowing for the use of medical marijuana. At the same time, the Department of Justice has made it clear that it opposes the use of marijuana under any circumstances.

Clearly, state law and federal law are on a collision course. I would not be surprised if there are more raids.

The problem with the DEA and marijuana comes from a federal government agency and their laws being at odds with the people. Few citizens object to the use of marijuana for medical purposes.

The government is fighting a losing battle. In the states where medical marijuana has been on the ballot, it has received overwhelming approval from voters. Canada and Great Britain recently approved the medical use of marijuana and plan to have the government grow and distribute it.

As medical costs skyrocket, medical marijuana is a cost-effective way to treat people with chronic pain. Most of all, making medical marijuana available is an act of common sense and compassion. The Corrals' collective lost 40 members this year; many of them left this world with Ms. Corral holding their hand.

As a society we have an obligation to weigh the risks and benefits of our marijuana laws. Most opposition to medical marijuana comes from a moral view. The data do not, in my opinion, support this opposition. Unfortunately, we rarely have a dispassionate discussion about this issue. The DEA raid only raises passions. Perhaps this ludicrous act will focus more attention and allow some courageous politicians (an oxymoron if I ever typed one) to start the discussion in Congress.

FTC Assails Deception In Weight-Loss Ads

I am working out in my mind a longer rant on this general issue. Read this article iand you will understand the illogical pursuit of the war on drugs - Pot raid angers state, patients . Where is the common sense?

McDonald's marketing cited for teens' obesity - a more complete report on the 2nd suit against McDonalds.

"We feel that the advertising strategies [of quick-service chains] target young children," said Samuel Hirsch, the attorney representing the teenagers. "Toy promotions and Happy Meals are a lethal combination."

Mr. Hirsch said his clients ate at McDonald's almost every day for at least five years. One teenager, who is 5-foot-9-inches tall, now weighs 270 pounds; another, who is 5-foot-3-inches tall, now weighs 200.

Obviously, neither the clients nor their parents should accept any responsibility for their weight. Responsibility is abandoned as a concept in this country, rather let's blame someone for our own shortcomings, and sue the bastards.

The lawsuit drew criticism from consumer groups and plaudits from medical groups, which said yesterday such cases alert people about the health risks of consuming fast food.
"We advocate for people to take control over their diets, but these lawsuits keep fast food in the news and point to the real issues that fast food can cause," said Brie Turner-McGrievy, a clinical research coordinator with the Washington-based Physicians Committee for Responsible Medicine, a nonprofit organization that promotes preventive medicine.

Others disagree.

"The Caesar Barber case was clearly a legal belly flop in the eyes of the public," said Mike Burita, a spokesman for the Center for Consumer Freedom in Washington.

"The trial lawyers are back at the drawing board, now using kids as their new pawns to try to get their multimillion-dollar payday in court. This has everything to do with fattening attorney wallets and nothing to do with slimming down Americans."

Either concept bothers me. You should not file a suit to attract attention. That concept perverts our legal system. This legal grandstanding sickens me. I certainly do no advocate poor diet, quite the contrary. Could the lawyers use their profits to pay for an advertising campaign for healthy diet and exercise? Could they defend the downtrodden? Why do they play the victimization game?

If you want to hear creative cursing, ask almost any physician what he (she) thinks of E&M coding. One cannot imagine a more Byzantine method for determing physician reimbursement. Only a truly confused bureucrat - or worse a committee of the confused - could have developed this system. Because the government determines payments using this system, I have to go to classes to learn it. The lecturer always starts saying that it is actually simple - and I zone out. That lecturer has started with a lie, and I cannot believe anything else said.

I am right!!! Study confirms: Even experts confused by Medicare coding: Specialized coding agencies can't agree on proper E&M codes. The system is indecipherable. The fundamental flaw is to link documentation to reimbursement. We have inflated charts - inflated with 'fluff' for billing purposes. Our charts should speak to the patient's problems and reflect our thinking and plans. Rather we document long histories, review of systems, social histories, and physical exams - on each and every visit!

A new study bolsters what many physicians have claimed for years -- Medicare's evaluation and management coding process is horribly confusing.

Researchers from the Dept. of Emergency Medicine at the William Beaumont Hospital System in Royal Oak, Mich., set out to determine how well even experts could do in appropriately coding emergency department visits.

The study, published in the September issue of Annals of Emergency Medicine, looked at the five E&M codes that represent 70% of the codes emergency physicians use to bill for their services.

The researchers, led by Raymond Jackson, MD, sent copies of 389 medical records to four private coding firms and asked them to correctly assign codes to the emergency department visits documented in the charts. They found little consensus.

The agencies agreed on the proper coding in