Federal Settlements: The ACRE Perspective

A brief footnote to the previous post on AstraZeneca and Seroquel:

As I reported a little while back, I had the pleasure recently of listening to a major presentation (at Davidson College, NC) by our colleague at Harvard and ACRE, Dr. Thomas P. Stossel: http://brodyhooked.blogspot.com/2010/04/encounters-with-dr-tom-stossel.html

Dr. Stossel did such a nice job of summarizing the world view of the ACRE folks that I will take this opportunity to comment on one point that's relevant to the recent AstraZeneca case.

Dr. S. was fully aware that when he tries to present his rosy view of the great advances in human well-being produced by recent Pharma and biotech breakthroughs, his critics will trot out "anecdotal" evidence of industry wrongdoing. One such anecdote is the settlement agreed to by a major drug firm when charged by the Feds with criminal conduct. As I recall, Dr. S. even provided his own list on a slide of some two dozen of these recent settlements.

He then gave the Pharma spin on that list. First of all, he said, if you think about all the wonderful new drugs and all the lives that they have saved, etc. this list looks pretty puny.

Second, we have to realize that in these cases, the drug companies are basically powerless and the Feds hold all the cards. The penalty the Feds can exact is capital punishment--a drug company found guilty of a crime automatically loses all ability to do business with Federal programs such as Medicare, Medicaid, VA, etc. for a certain number of years. That would be the death knell for any drug firm. So companies accused of crimes by the Feds cannot take the risk of defending themselves in court; they have no choice but to settle. Therefore (implies Dr. S.) most of these charges are completely false and baseless, and the companies settle solely because they are forced into it. (And of course, in most cases, the company denies wrongdoing as part of the settlement.)

OK, so that is the ACRE take on the matter. My replies:

• It is reassuring to know that the Feds do not find evidence of criminal wrongdoing in the marketing of every single drug that has recently come on the market. What I think the list proves, however long or short it is, is exactly the point that I have stressed ad nauseum in this blog--that we see here a recurring business strategy across the entire industry and not the actions of an occasional rogue firm.
• If you look at what it takes to put together one of these legal actions against a drug company--usually an inside whistle blower plus some 5-6 years of legal investigation--it is not surprising that a relatively small number have been brought. We can argue over whether these are all unjust accusations against firms of stellar virtue, or merely the tip of the criminal iceberg.
• The "capital punishment" works both ways. The Feds (specifically, the White House and DHHS, given that the executive branch and DOJ are the ones bringing the suit) know what would be the consequence of actually putting AstraZeneca, Pfizer, Merck et al out of business. First, all their thousands of employees are thrown out of work in the middle of a major recession. Second, millions of patients who rely on brand-name drugs that have no generic equivalent suddenly are deprived of those drugs without warning. If you imagine the political pressure generated by both of those aggrieved lobbies, you can see why the Feds simply would never lower the boom completely on a drug company guilty of even the most egregious behavior. (We have to add that the actual criminal behavior was no doubt engaged in by a tiny handful of company employees, with the vast majority of the workforce being blameless.)
• The end result is that the Feds go well out of their way to never shut down a big drug firm--and resort to subterfuges such as in the Pfizer case, where they "shut down" two drug firms that had actually shut down years previously and no longer existed except as paper targets (http://brodyhooked.blogspot.com/2010/04/cnn-pfizer-too-big-to-prosecute-shadow.html).
• So the real power remains in the hand of the drug firm that's "too big to shut down," analogous to the Wall St. bank that's "too big to fail."

As I have argued in the past this seems to support the role of criminal prosecutions (perhaps for misdemeanors) of high officials of the drug company rather than "capital punishment" for the whole firm. (See post linked above.) But at any rate, the ACRE view of how this all goes down seems to me about 180 degrees off kilter.

The Cost of Doing Business: Same Song, 83rd Verse

And today, the drug company settling with the Federal government on criminal charges against off label marketing is:
AstraZeneca
The drug involved is: Seroquel (quetiapine)
The amount of the settlement is: $520M
The settlement equals what percentage of one year's sales of the drug?: 10.6%
Did the company admit wrongdoing? Yes/No: Of course not
Link to detailed news coverage: http://www.nytimes.com/2010/04/28/business/28drug.html?emc=tnt&tntemail0=y

As you can see, it saves time if I just make it a fill-in-the-blank form.

First, general background: Seroquel is one of the supposedly new-generation antipsychotics that was initially touted as both more effective and safer than the older antipsychotics of the thorazine-haloperidol era. More recent research has disputed the claims of both greater efficacy and greater safety, and calls into question the entire concept of "generations" of these drugs--see for instance http://brodyhooked.blogspot.com/2009/01/are-second-generation-antipsychotic.html. We are sadly not surprised to learn that at every step of the way, the drug companies sponsoring the research, and their physician lackeys, have worked their tails off to distort the research record and to make these sows' ears look like silk purses. In the process they have especially pushed the drugs (due to their supposed safety profile) for use in the elderly, despite the fact that the drugs can cause serious weight gain and tip susceptible patients over into frank diabetes. Because psychiatrists see too few patients to create a really blockbuster market, and expert psychiatrists might actually know something about the downside of these drugs, much of the marketing focus has been on my colleagues in primary care--again relying on the supposed safety profile of the drugs to encourage non-psychiatrists to feel comnfortable prescribing them.

The Feds charge that AZ paid kickbacks to docs as part of a scheme to market the drug for unapproved uses, especially in kids and the elderly. The specific Fed claims include:

• AZ inapproprately influenced the content of CME courses they funded
• AZ hired docs to give talks and do research on unapproved uses
• AZ recruited medical "opinion leaders" to be the fake authors of ghostwritten articles touting Seroquel for unapproved uses, and AZ then used those articles for marketing
• AZ paid docs to come to fancy resorts to "advise" AZ on how best to market Seroquel for unapproved uses

All of this is in violation of Federal anti-kickback statutes.

Based on some of the buzz on the Healthy Skepticism listserv, it appears that this story will not go away quickly. The Feds appear ready to out the academic and other physicians who took those kickbacks.

Being held to public ridicule for taking drug company money to shill for them, illegally, may produce a small incentive among academic physicians at least to watch out for these sorts of entanglements with Pharma in the future. As we have seen many times before, the amount of the settlement, by itself, is hardly a factor, since the company gets about 9 times that much in revenues for every year the drug remains on the market. You can add to that the $656M that AZ has reportedly spent so far to defend itself against about 25,000 civil lawsuits over Seroquel. (If the Vioxx/Merck example is any indication, AZ stands ready to win the vast majority of those suits, given the near-impossibility of proving in a court of law that any individual patient developed diabetes or any other complication solely due to Seroquel and not due to any other co-existing conditions.)

As we have said before, so long as the "cost of doing business" is so reasonable, we can expect drug companies to push the legal envelope regularly, and like Pfizer, swear never to do such dastardly deeds again at the same time as they are planning the next set of dastardly deeds with a newer drug (see http://brodyhooked.blogspot.com/2010/04/cnn-pfizer-too-big-to-prosecute-shadow.html).

How Good Are Generic Drugs?

Thanks to Merrill Goozner for his report and insights:
http://www.thefiscaltimes.com/Issues/Health-Care/2010/04/22/Generic-Drugs-on-the-Hot-Seat.aspx

First, some of my own background: There are several issues that concern us on this blog that all in some way implicate the safety and efficacy of generic drugs as equivalent to brand-name drugs. Specifically, if it were to turn out that we could not rely on generics as reasonably equivalent to the brand-name in a therapeutic sense, then a number of the pieces of advice that we'd like to give to the physician, on how to save money for patients, how to keep well informed about drugs, etc. would no longer be valid and we'd have to start over from scratch. That is why it was a truly big deal when, back in 1989, a Congressional inquiry revealed a payola scandal within the FDA's generics division that allowed non-equivalent drugs to slip through the net (as I briefly described in HOOKED). What I have written since then all assumes that the problem at the FDA was fixed. The issue is especially timely today as many widely-prescribed brand-name drugs either have just gone generic in the past couple of years or are poised soon to do so.

Now, over to Gooz--his article briefly reviews recent charges, taken up by some popular magazines and by psychiatrists in particular, about patients who switched to a generic drug and had an immediate worsening of their symptoms. This led the FDA to convene an advisory committee to review the standards it uses for determining bioequivalence. The short answer is that the FDA internal investigation showed that even if they had adopted a stricter standard, the specific drugs that have recently been questioned all fell within those tighter limits--so there was no scientific reason to change the standards.

Gooz's analysis is extremely helpful because he distinguishes two FDA functions--generic drug approval and on-site inspection of drug manufacturing facilities. Megabrand Generic Drugs Inc. might submit their formulation for a generic version of (say) Zoloft to the FDA. There is, at present, no evidence at all that there's anything wrong with the process the FDA uses to approve that chemical formulation. But then somebody actually has to run a big machine in a big factory and make millions of those generic pills or capsules. And that is where the available evidence would suggest that things could get dicey--especially if the factory is in China or some other country prone to either official corruption or sloppy standards or both. The FDA, it is now widely admitted, has way too few inspectors to keep an eye on all the outsourced drug factories that supply their wares to the US market, as we found out with tainted Chinese heparin recently. So we should fix that and not worry about the official generic approval standards.

Now, my own advice as a no-longer-practicing family doc. What should the physician do when the patient says that after switching over to a generic brand, he has a new side effect, or the drug stopped working? As I understand the matter, two different brands of the drug may be chemically different, having, for instance, a different type of chemical filler. So I have no trouble believing that no matter what FDA standard the generic drug passed, this individual patient just might have a chemical idiosyncrasy so that his body absorbs some substances differently, etc. (Or he might not--the difference truly might be imaginary, or a negative placebo effect--but the research needed to find out for sure is way beyond the time and abilities of most practitioners.) In such cases I always wrote the prescription so as to return to the brand name drug. I never told the patient I did not believe him, or that what he said could not be true because generic drugs are equivalent. And if the insurer did not want to pay the higher price, I always went to bat for the patient (and made sure the reported difference was documented in my chart note to back up the patient's story). But at the same time, I felt obliged to tell the patient not to assume that this meant that other generic drugs were no good. I explained that the same thing could have happened, had he initially been on a generic drug and had been switched to the brand name version. The problem in his case, I proposed, was switching to a different chemical formulation, not to a (generally) worse chemical formulation. The number of patients who ended up needing this special treatment was a miniscule percentage of my practice, so I never thought of it as breaking the bank, but rather as personalized medical care.

Council of Medical Specialty Societies Code: Strong Enough?

The Council of Medical Specialty Societies, of which 32 medical specialty professional organizations are members, has announced a new "Code for Interactions with Companies." Their press release is at http://www.cmss.org/DefaultTwoColumn.aspx?id=110, and the full Code is accessible at http://www.cmss.org/uploadedFiles/Site/CMSS_Policies/CMSS%20Code%20for%20Interactions%20with%20Companies%204-19-10.pdf.

The news release suggests that this is a well-intentioned attempt to address conflicts of interest in medical specialty societies, with a special focus on their role in writing clinical practice guidelines. The Preamble states: "Members and patients count on Societies to be authoritative, independent voices in the world of science and medicine. Public confidence in our objectivity is critical... We know the public relies on is to minimize actual and perceived conflicts of interest. ... [E]very society must be sure its interactions with Companies meet high ethical standards."

I read through the complete Code to try to form an opinion as to how much teeth the Code actually possesses. Based on the most recent flap regarding my own medical specialty society to come to my attention--the AAFP-Coca-Cola deal-- I paid special attention to whether that deal would have been prohibited by this Code. (AAFP is one of the members of CMSS). (For the most recent post here on AAFP, see http://brodyhooked.blogspot.com/2009/12/aafp-coca-cola-deal-letter-to-member.html.) As everyone with whom I have consulted, except for the AAFP leadership, seems to believe that the Coke deal was a clear no-no and a serious conflict of interest, I figured it was a reasonable test case.

As best as I can read the Code, AAFP would have a green light on Coca-Cola. There seems no doubt that the general spirit of this Code runs contrary to the AAFP-Coke deal. But at each critical juncture, the Code seems to leave enough wiggle room for the deal to be justified. For example, so long as AAFP claims to have done all the following:

• decide that writing educational materials for consumers on healthy eating is part of its mission
• decide to include guidance on beverages and soft drinks, independent of the Coke deal
• reveal funding from Coca-Cola
• assure everyone that the content of the materials will not be determined or dictated by Coca-Cola
• Have an internal set of conflict-of-interest policies which it follows in dealing with Coca-Cola

--then the deal is supposedly kosher. The only "violation" I can see is AAFP's failure to reveal the exact amount of the funding that it received. ("Strong six figures" is how the AAFP Prez was quoted in the press.)

A good deal of space is devoted (appropriately) to CME programs. Here I would criticize the Code for being too quick to rely on having funding from multiple firms to make sure everything is above-board. As we have discussed numerous times, getting funding from many drug companies does not eliminate bias in CME; rather, it tends to assure that all the presentations at the CME program will be about drug therapy, with nothing said about exercise, diet, etc. The Code does call for presenters at CME "to give a balanced view of therapeutic options."

We next come to the critical section on practice guidelines-- critical because it has been generally held by guideline critics that of all practice guidelines, those published by medical specialty societies are most likely to be riddled with commercial biases and conflicts. Here I was hoping for a strong statement that guideline panels would be made up of individuals without conflicts of interest, period. The Code instead insists on disclosing conflicts and requires then only that a majority of panelists are free from conflicts of interest relevant to the subject matter of the guidelines. There also seems to be a major loophole in that commercial firms cannot fund guideline development; but they can give funds to a society for later distribution and "repurposing" (whatever that is). To me this suggests a likely route for a sweetheart deal. A firm might let it be known that if a society comes up with a practice guideline that strongly endorses a treatment strategy using a drug that the firm sells, it will later on be willing to pay millions of bucks for "further distribution" of those guidelines. The society might well decide it's worth it to front its own funds to write the guideline, knowing that the firm's later largesse will effectively reimburse it for all expenses and then some. Finally the Code states, "Societies will recommend that Guideline development panel members decline offers from affected Companies to speak about the Guidelines on behalf of the Company for a reasonable period after publication" (emphasis added). Why be mealy mouthed about it? Why not just say flat out that if you agree to serve on a guideline panel, you also agree not to also serve on a company speaker's bureau for X number of years--period?

CMSS proposes to post a list on its website of Societies that sign onto this Code (including societies that are not CMSS members). Societies will be encouraged to certify annually to CMSS that they continue to adhere to the Code." Again-- why not demand annual cerification as a condition of being listed?

Great first draft, guys. When you next revise it, stiffen it up a bit. The Code emphasizes that individual Societies are welcome to adopt stricter provisions than what is in this Code--and I hope they do so.

Note added 4/24: Our esteemed colleage Dr. Danny Carlat had a very amusing and rather more cynical take on this Code-- see his post: http://carlatpsychiatry.blogspot.com/2010/04/medical-societies-new-ethics-code.html
In short he depicts the Code as pure PR fluff with no substance at all.

Encounters with Dr. Tom Stossel

I spent some of last week at Davidson College in North Carolina, in the company of Dr. Thomas P. Stossel, driving force behind ACRE (Association of Clinical Researchers and Educators). Both Dr. Stossel and ACRE have come in for considerable criticism on this blog, so I thought a brief report was appropriate. I am first happy to be able to say that Danny Carlat, over at his psychiatry blog, was correct--I found Dr. Stossel to be personally very congenial and affable regardless what one thinks of his opinions on medicine-Pharma issues. I discovered that he and I have equally compelling reasons for psychopathology, having each of us been raised in our tender years as Chicago Cubs fans.

He and I each spoke at the Speas Colloquium, an annual medical ethics program at Davidson (where our host was Lance Stell, philosopher and another ACRE stalwart). I spoke in defense of the meaningfulness and relevance of the notion of conflict of interest. Dr. Stossel gave an overview of the ACRE position that defends financial ties between medicine and Pharma as the engine that drives innovation, and that sees all recent attempts to limit those ties as both unnecessary and harmful. My limited attempt to hold out an olive branch was to note that ACRE contains a lot of expertise on how medicine can collaborate with Pharma around biotech and pharmaceutical research, so that they could be leading the way to develop an ethically sounder relationship between medicine and the pharmaceutical industry--if only they would admit, for starters, that we currently have a problem. Dr. Stossel obviously was having none of that. He continues the trend in his previously published work of minimizing all bad stuff that happens at the med/Pharma interface--the stuff I have to find time weekly or even more often to post here--as disconnected, rare anecdotes, not as any sort of recurring or worrisome pattern.

In most respects I thought that the talk he gave at Davidson was more or less what we would expect, based on his previous publications. The exception was one slide that he presented on professionalism. The primary source he cited was the recent book by David Wootton, Bad Medicine. The point seemed to be that when folks like me who are concerned about undue influence of commercial interests on medical practice cite "professionalism" as our concern, this ought to be questioned if not dismissed--that much more harm than good has been done over the centuries by invoking "professionalism" in medicine, that "professionalism" has often stood in the way of accepting new scientific evidence, and that it is simply wrong to characterize medicine as something over and above a business. (In short, the sorts of arguments that result when one ignores the more recent, ethical sense of 'professionalism' and invokes only the descriptive, sociological sense of the term.)

My comment here would be that it is perhaps indicative of the strength of the arguments raised by the ACRE folks, to see how wide a swath of ethical countryside they have to lay waste to, in order to defend their chosen position. They want to defend docs taking bundles of cash from Pharma; we invoke conflict of interest as an ethical concern with that approach; so they decide they have to throw out conflict of interest. (Not limit or refine the scope of conflict of interest, mind you, but completely dispense with it.) So now we continue to worry about their heels with some quaint ideas of medical professionalism; and they now find it necessary to dispense completely and totally with medical professionalism. It is not merely a matter of throwing out the baby with the bathwater. It appears to be the baby, the rest of the family, the dog, and the hearth, and still they are not done.

Forget Blood Tests, Just Treat with Statins? More (Partial) Evidence

Warning: If you are up to here with my ragging on about statins and cholesterol, skip this post. The reason I am pursuing this is to try to get to the bottom of the influence of Pharma marketing over both medical science and actual physician prescribing behavior, and I think the statin/cholesterol/prevention story is a rich and multifaceted case study.


A study published in January in Annals of Internal Medicine would seem at first glance to be yet another important piece of evidence with regard to the "lipid hypothesis"--whether statins actually work solely or even primarily by their lipid lowering effects, or if they actually work by some other means such as anti-inflammatory. At a closer look, it does indeed add further evidence that the lipid hypothesis is shaky at best, and it makes a good point about practical strategies for managing heart disease risk. But ultimately it fails to be as important as it might be because it compares only options A and B, when the really best options are probably to be found among C, D, and E.

A team headed by Drs. Rodney Hayward of U-Michigan and Harlan Krumholz of Yale (IMHO, meaning the study is both high quality, and not bought off by Pharma) set out with funding from the VA to try to compare two strategies for preventing heart disease with statins. The "treat to target" strategy is what all the guidelines recommend--measure cholesterol levels, start a statin, keep checking the blood levels and adjust the medicine until you have reached a target level of cholesterol (or, specifically, "bad" cholesterol or LDL). (These guidelines, I hasten to add, were mostly written by folks whose pockets are deeply lined with industry cash, as we have previously discussed.) Hayward and colleagues wanted also to test a "tailored treatment" strategy, which consists of two doses of two different statins. On this strategy, you decide what the cardiac-disease risk level of the person is from some population measurement tool such a Framingham. If the person is medium risk you pick a lower dose of a generic statin. If they are at especially high risk you pick a higher dose of a more potent statin. In neither "tailored" case do you bother to measure cholesterol levels, now or later. The "tailored" strategy is, so far as I interpret the literature, more evidence-based than the "treat to target" strategy.


Cutting to the chase, Hayward and colleagues knew that to do this study as a randomized clinical trial would require huge numbers of subjects, about a decade, and many more bucks than they had on hand (being funded by the VA). So they chose instead to do the study as a mathematical modeling exercise. The things that make their model apparently quite robust were, first, that they made a set of assumptions that slanted in favor of the "treat to target" strategy; and second, that they did a whole slew of sensitivity analyses to see if changing any of many different assumptions changed the outcomes.


Their results were a resounding win for the "tailored treatment" strategy. They could not find a set of assumptions that made the "treat-to-target" strategy come out better in terms of patient benefit. (They did not consider cost in their study, probably simply taking it for granted that the strategy that did away with the need to chase cholesterol levels all over the place would be the cheaper strategy, especially when combined with maximum use of generic drugs.)


So two things seem to follow, at first glance, from this study. One: treating with statins based on risk classification, not based on cholesterol levels, is the better way to go. Two: as both treatment strategies resulted in saving lives and quality-adjusted life years over baseline, then statins are indeed good for primary prevention of heart disease, and the only question is how to use them best.


So: is the first glance view accurate? I think not.


Consider what the study, for all its sophistication, did not test. There was no comparison between trying to use statins for primary prevention of heart disease, using either strategy, and the best reported results of diet/exercise/lifestyle interventions. Also, there was no comparison between a single, low dose "tailored treatment" strategy and the authors' two-dose variation. If one is to believe the work of James Wright and John Abramson in particular, there should have been no difference.


So the question, then, is on what basis did Hayward and colleagues decide that primary prevention with statins works? The answer--they assumed it to be so. They admitted up front that as part of their plan to give up as much handicap as they could to the opposing strategy, they made two assumptions-- that reducing LDL cholesterol accounted for 100% of the statins' beneficial effects; and that reduction in LDL cholesterol is a 100% accurate accounting of how much benefit an individual receives from taking a statin. They immediately add that the first assumption is quite controversial and the second is demonstrably untrue.


They chose to make these assumptions because it suited their narrow purpose of demonstrating the superiority of their "tailored treatment" strategy, and for that purpose it was quite an effective way to design their study. For our purposes, however, those same assumptions mean that we cannot use this study to test out the more skeptical--and I think more evidence-based--positions on statin use in primary prevention.

When I ran a draft of this post by EBM-mayvin Jerry Hoffman at UCLA, he kindly added the observation that I needed to mention "number needed to treat" (NNT). The way Jerry put it, suppose that we located the most up-to-date statistics and presented to a bunch of higher-risk men the option to take statins for primary prevention of heart disease, or not, using the so-called "tailored treatment" approach now that we know it's superior. There is no guarantee that these men would choose the statin therapy even under these "superior" treatment conditions--if we told them frankly about how many of them would have to take a statin before one of them had benefit (such as avoiding a heart attack or death). If men knew that as many as several hundred would have to take statins (being exposed to all the risks of adverse reactions) so that one would get a benefit, they could very reasonably say "no thanks." So even the "superior" treatment strategy is potentially undesirable if the NNT statistics from many large clinical trials are valid.


It is nevertheless nice that we have one more argument to use against extensive screening for cholesteol and LDL and increasing statin treatment levels if the targets are not met. Finally, in conclusion, Hayward et al make an excellent point. Why, they ask, did the "treat to target" strategy ultimtely fail? Their conclusion-- it overemphasized one single heart-disease risk factor, LDL, at the expense of not taking into account the total picture of the individual patient's heart disease risk status. That led to some patients being overtreated, some being undertreated, and overall, less net benefit. This is yet another argument that if anything should guide the use of statin therapy, it's the patient's overall risk status and not any single blood test.

Forget the Science; Docs Already Know the Answers

Thanks to a faithful follower, I was clued into the program on Minnesota Public Radio last week:
http://minnesota.publicradio.org/display/web/2010/04/08/midmorning2
The Midmorning program addressed the recent decision of the FDA to allow a relabeling of rosuvistatin (Crestor) based on the JUPITER trial, about which I blogged several times, such as:
http://brodyhooked.blogspot.com/2008/11/by-jupiter-slick-drug-marketing-great.html
Midmorning had two guests familiar to regular readers of this blog: cardiologist Dr. Steve Nissen of Cleveland Clinic, and family physician Dr. John Abramson. Both are usually known as critics of the pharmaceutical industry. In this instance they took mostly opposing views, Nissen defending the JUPITER results while Abransom took a more skeptical view (with which the bulk of the opinions I blogged about would agree; see http://brodyhooked.blogspot.com/2008/11/by-jupiter-part-ii-more-skeptical-view.html).

Two comments on the program. While the listeners heard pro and con views regarding the reliability of JUPITER, they did not hear much about what I consider the major news from that trial, which is to knock a further hole in the lipid hypothesis for heart disease, that claims that statins prevent heart disease primarily by lowering cholesterol and that regular cholesterol testing is a critical part of good preventive medicine.

The second comment is perhaps the more important, and includes the only mention that I heard of the challenge to the lipid hypothesis (though neither Abramson nor Nissen picked upon it). During the call-in part of the program, a family physician from Marshall, MN, "Vince," offered a different perspective which he presented as representative of all of the family docs he knew. He said that all of them, on reaching age 50, if they had the slightest hint of a risk factor for heart disease, immediately put themselves on cheap generic simvastatin. Vince agreed with those who believe that the lipid hypothesis has been largely disproved, and was quite willing to say that 1) statins probably work more due to their anti-inflammatory effects and not due to cholesterol lowering effects; and 2) therefore, checking cholesterol levels with repeated lab tests is pointless. But Vince also said that he and all his colleagues were completely convinced that statins were effective for primary prevention of heart disease, they hardly ever saw any serious side efects with statins, and now with generic prices they were dirt-cheap, so why not take one?

My own point of view is that "Vince" represents a fascinating partial victory of pharmaceutical marketing over science. (Both Nissen and Abramson agreed to disagree with Vince.) He's right, I think, in debunking the lipid hypothesis. But I think his confidence that statins are so wonderful for primary prevention reflects the huge success of Pharma brainwashing (see my last post on JUPITER-related stuff, http://brodyhooked.blogspot.com/2009/07/more-on-statins-new-bmj-meta-analysis.html.) It's one of those many features of today's medicine that future medical historians will look back on and shake their heads over.