Melody Petersen's OUR DAILY MEDS: Scary Things

In writing HOOKED, I relied very heavily on a series of excellent articles that investigative reporter Melody Petersen wrote for the New York Times between 2000 and 2004. Petersen then sort of dropped out of sight. Apparently this book was the fruit of her interim labors.

The first two-thirds of the book will be pretty much old news to regular readers of this blog. It rehearses how aggressive marketing replaced the discovery of new and useful drugs as the pharmaceutical industry's main line of work, and how all too many physicians were all too happy to acquiesce in the process so long as their pockets, or stomachs, were well lined. In other words, what has already been written about pretty thoroughly in recent books--even if Petersen was the first to report on some of these events in the NYT.

Things get more interesting in the final third of the book. Petersen starts to detail a list of more distant ripples of the overmarketing of pharmaceuticals--like how many different drugs can now be found in the US water supply; how many deaths per year from auto accidents were actually caused by drivers zoned out on prescription drugs; how little we know about how many deaths per year are actually due to prescription drugs; how readily grade school and high school kids now trade each others' prescription drugs back and forth even as illegal street drugs are going out of fashion among them.

I can probably best give the flavor the the book by summarizing the list of recommendations Petersen makes at the very end:

• Redesign the standard death certificate to make it easier to record prescription drug use as a contributing cause of death. Do many more autopsies to be sure we know what really has caused deaths.
• Outlaw physicians taking any money from the pharmaceutical industry. (If we can outlaw DJs taking money from record companies, says Petersen, why not?)
• Create an NIH-type agency to oversee pharmaceutical research and assure scientific integrity of results.
• Assure that patients receive the full information about drugs, in readily understandable form, before they are prescribed. (Petersen is sure that if patients knew how poorly many heavily advertised drugs really work, they'd refuse many of them.)
• Repeal FDA drug company user fees and generally stiffen the agency's spine to regulate the industry.
• Stop covert drug marketing through celebrity endorsements, ads masquerading as news on local TV, health fairs and screening secretly funded by industry, and industry largesse to non-profit patient advocacy groups without disclosure.
• Do more testing of drivers who cause accidents for prescription drugs and require clear warning symbols on labels of drugs where driving is warned against. Punish docs who fail to warn their patients that they should not drive when taking a drug.
• Throw executives in jail if the company commits fraud--forget the "big" fines that companies now regard as a simple business expense.
• Focus more effort on prevention and less on taking pills after you get sick.

One final irony--Petersen has a chapter on the outrageous prices drug companies now charge for sopme drugs, especially those for cancer treatment. One example she gives is an Iowa woman who complained when a single prescription for Thalomid, the medicine that she takes for her multiple myeloma, cost $5000. Petersen neglects to explain what Thalomid is. In the old days, it was known by its generic name, thalidomide. Yes, it's the same drug that caused the horrendous birth defects back in the early 1960s and led to the Kefauver-Harris amendments of 1962 that gave the FDA broad new powers to requre evidence of efficacy as well as safety of drugs. After years of no one being willing to touch that drug with a ten foot pole, it has found new life for limited uses like multiple myeloma. But the very idea that this drug, which is older than dirt and pretty easy to manufacture, should be priced at $5000 a presciption beggars belief.

Federal Sunshine Bills: Where Do We Stand?

I was asked by some of my friends at the National Physicians Alliance for comments on the Physician Payment Sunshine Act now before Congress. I had not commented previously because I was waiting to see what version of the proposal seemed to be going forward. There is now a House bill, and a Senate bill that has been revised from the earlier Senate version. Our colleagues at the Prescription Project seem to believe that some action is imminent on the Senate side, and have prepared a Fact Sheet on the legislation comparing the House and revised Senate bills. (The Fact Sheet may be a working draft as I cannot find it on their website.)

I’m relying here on the Prescription Project summary plus the text of the revised Senate bill. I’ll state first the facts as shown by those sources and then my own comments in bold italics.

The Senate bill would apply to any drug or device company. The House bill applies only to companies with annual revenues greater than $1M. I see no reason to restrict reporting requirements to larger companies. If they make enough bucks to give physicians some, then they can report.

Payments to docs that would have to be reported (in the Senate version) includes gifts, food, entertainment, travel, honoraria, speaking and consulting frees, stocks or options, and funding for clinical trials. The House version excludes clinical trial funding but does include funding for non-clinical trials such as health services research. The House version, unlike the Senate, includes also participation in continuing education and items provided at less than market value. I would agree with the House version that costs related to continuing education, if paid directly from the company to the physician, amount to a cash equivalent and should be reported. I also would include both types of research in the reporting requirement. Commercial bias can be even more blatant in non-clinical trials such as cost-effectiveness analysis.

The Senate also exempts more items from the reporting requirement compared to the House. Both exempt gifts and payments less than $25, samples, things provided to the physician when the physician is a patient, and compensation to a physician who is a company employee. The Senate additionally exempts payments to individuals unless the aggregate annual value per company reaches $500 (from which calculations all gifts less than $25 are excluded); discounts and rebates; educational materials intended for patient use; and “the qualitative value of training or education,” whatever that means. I would argue that the $500 aggregate, excluding the $25 individual gifts, is way too big a loophole and encourages companies to break up gifts into smaller pieces. On the other hand, the Prescription Project is worried about the educational materials for patient use as a loophole, and I admit that I cannot quite see how that would be a big problem, so I’m inclined to give the industry a pass on that one.

The bills proceed to require that disclosures be made regularly to DHHS, and that the reports be placed within a reasonable time on a public website that is easily searchable, listing the doc’s name, address, facility affiliation, amount of payment, and category of payment. The bills have varying penalties for noncompliance; the House bill has no cap but the Senate bill would cap possible penalties at $50,000 for failure to report and $250,000 for “knowingly” failing to report. We have seen in Minnesota that having a required reporting law without the corresponding requirement that the information be easily publicly available and searchable yields no disclosure, so the requirement for the website and its specifications seems essential. The problem with any capping of possible fines is that we are talking about an industry which appears ready to spend at least $50 billion annually marketing drugs to physicians. Fines of even many millions of dollars are like mosquito bites to the large drug firms. I can see no justification of any cap. How you get a fine to be big enough so that the industry will take notice is as yet an unanswered question.

The Senate but not the House bill would pre-empt existing state reporting laws. I agree with the industry argument that it would be onerous to have to report one set of figure with one set of specifications to the Feds and a completely different set to a state like Vermont or Minnesota. On the other hand, this entire measure of legally required disclosure as a tool to fight undue industry influence over physician prescribing is a work in progress. It is highly unlikely that any Federal law will get it just right the first time out. I think we need to permit states, at least for a while, to experiment with more stringent requirements if the political will exists. I doubt there will be so many such states as to create huge hassles for the industry. Remember, these are data that the industry routinely tracks on its own for internal purposes. We are not asking companies to start gathering a completely new sort of data. If the Federal reporting process works well, individual states can be expected to repeal their own reporting requirements, if for no other reason than to save state officials the hassle.

Finally, the Senate bill would not take effect till 2011. I would agree with perhaps a year’s lead time, but I see no reason at all for that long a delay.

Business As Usual: Big Pharma Pays Off Generic Makers Not to Compete

From Reuters:

http://www.reuters.com/article/marketsNews/idUSN2328640520080523

...Comes word that the FTC has noted 14 instances last year in which a brand-name drug firm has entered into a financial deal with a generic maker to delay the entry of a new generic equivalent drug into the market, effectively extending the brand-name drug's patent protection (and monopoly ability to keep charging high prices) by many months.

This "evergreening" strategy as discussed in HOOKED is a violation of FTC policies, according to the views of that agency; but pro-corporate judges in the Federal courts have periodically been willing to allow these deals, so apparently all the FTC can do now is report these and say "tsk, tsk."

Now, I am no judge and no economist, and I don't have an MBA degree. But it seems contrary to public policy when a big drug firm can pay off a generic firm not to sell a cheaper generic drug, and the consumer ends up having to pay the higher brand-name prices. Sounds somehow anti-competitive to me. But to the Federal courts it's simply business as usual.

Lest you think that making side deals with generic makers and paying them off not to compete with you, is the only way to "evergreen" a brand-name drug about to go off patent, I'm informed by the latest issue of The Medical Letter that Wyeth has received FDA approval for its new antidepressant, desvenlafaxine (Pristiq). Wyeth's antidepressant venlafaxine (Effexor) is now available generically for the immediate-release form, and the extended-release form is going off patent in 2010. What is the "new" drug? It's the active metabolite of the old drug--that is, the substance that your body naturally changes the old drug into as soon as you absorb it. In other words, the same drug, but it's chemically slightly modified so they get to patent it and sell it at brand name prices just as if it were a real breakthrough. The only good news is that the announced price so far for the "new" drug is not that much higher than for the generic "old" drug. This is just one in a line of "new" drugs that are produced merely by a small tweak in the molecule of an "old" drug, the transformation of the "old purple pill" Prilosec into the "new purple pill" Nexium being the best known case. I am always atruck by the coincidence that the company's scientists find a way to "improve" the old drug just about the time it's ready to go off patent. Somehow that improvement never occurs to them when the drug still has a lot of years of patent life yet to run.

California Bill: Sell Pharmacy Records to Drug Firms?

According to the San Francisco Chronicle:

http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/05/28/BAJC10U9GB.DTL

...a bill has been introduced into the California legislature, which has previously enacted some of the tightest medical privacy provisions in the nation, that would allow pharmacies to sell patients' prescription information to third parties working for drug companies. The proclaimed reason for this is that people forget top take and refill their essential medicines and this way, the benign drug industry can send benign reminder notices to folks and benignly improve their health.

In the past, opening this door has led to direct-to-consumer marketing mailings, in a manner that makes it hard for the average patient to detect that the sales pitch to take more or newer drugs comes from a pharmaceutical company and not from their physician or pharmacy.

It may, in fact, be a good idea to send patients reminder notices to get them to keep taking truly essential medicines. (The matter of course is open to study.) But simple common sense would seem to dictate that this should not be a profit-driven enterprise engaged in by those whose overt agenda is to sell more drugs.

The Private Physician as For-Profit Researcher: Ethical Problems

In HOOKED, I cited a study by anthropologist Jill A. Fisher of Arizona State, who conducted ethnographic research in her region of the country on private practitioners who signed up to do research with contract research organizations (CROs) in order to increase practice revenue. Her earlier report was interesting mainly for how research was "sold" by the CROs to the docs ("any idiot can do it"), and how the docs immediately offloaded all the major research tasks onto their lowest-paid office assistants--who then often became very dedicated enthusiasts for the proper and ethical conduct of the trial.

In the present study, Fisher follows up with more analysis of how the physicians themselves viewed the ethics of research. Even though the reason these physicians are attractive to the CROs is that they presumably control a large population of patients, and even though the patients are their patients, Fisher describes a thinking process in which the docs come to see themselves as bound to the interests of the pharmaceutical industry, and not as protectors or advocates for the human subjects enrolled in the studies. For example, when asked why they should not fudge results, some respondents commented not in terms of the ethics of research, but how if your site got a bad reputation you'd lose future CRO business.

I find this intriguing in terms of my own expeience in practice-based research. As an academic family physician, I was for many years involved in a department where a high priority was placed on the creation and sustenance of practice-based research networks, involving private practitioners as well as academics in research, in order to assure that the population on which the study was carried out represented the "real world" of family medicine in the community. These investigators were, as a rule, not paid, and did research as part of their practice beause they thought it was a good thing to do. There were clearly ethical conflicts created by having one's personal family physician also play the role of a resarch investigator--most notably, the way patients could feel pressured to enroll in studies. On the other hand, these docs also became very avid students of research technique and methods, again mostly out of their own interest and commitment--far beyond the simple weekend seminar (with golf thrown in) offered as "training" for the private docs by the CROs in Fisher's sample. So despite the importance of the ethical concerns in both situations, the motives and general thinking of the practice-based primary care physician-investigators and the current crop of CRO recruits seem like night and day. Big surprise--if Pharma pays the piper, Pharma calls the tune; and the piper knows right away whom he works for.

Fisher JA. Practicing research ethics: private-sector physicians & pharmaceutical clinical trials. Soc Sci Med 66:2495-2505, 2008.

More on Hospitals Adopting Strict Policies Limiting Pharma

Thanks to our friends at the Prescription Project for mention of this article in the ACP Hospitalist:

http://www.acponline.org/clinical_information/journals_publications/acp_hospitalist/may08/cover.htm

In the process of reviewing a number of hospital policies that bar various forms of Pharma influence, the article touches upon several examples we have previously reviewed here, and basically goes over mostly familiar ground. Perhaps most inteersting is the conclusion of the story, with various tips for making this happen at your hospital or clinic if it's not already on the bandwagon--including the simple bit of advice, "Just do it." More evidence that the momentum is slowly changing direction?

Merck Vioxx Ad Settlement: Industry Back-Pedalling?

More possible evidence that the drug industry is currently back-pedalling in the face of rotten publicity over failed new drugs, heightened Congressional scrutiny, and loss of public respect comes from the announced Merck settlement of lawsuits alleging inappropriate direct-to-consumer advertising of Vioxx. So far all I have read about this is the summary of news reports in the Kaiser Daily Health Policy Report (other links in report): http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=52276

The settlement has Merck forking over $58M which of course is peanuts to major drug firms. Here's what appears to be significant--first, Merck has agreed to tight controls on future ads; and second, quite astounding in my view, Merck has also agreed to end ghostwriting practices (though given the secrecy with which ghostwriting of scientific papers occurs, how are we to know about compliance?). The main significance of this last provision, if any, is that Merck presumably had to admit to ghostwriting if it agreed to stop. I also wonder--if Merck was this ready to say it would give up ghostwriting, could it be because Merck sees the handwriting on the wall as medical centers move to adopt much more Pharma-unfriendly conflict-of-interest policies--and has made the guess that in the future it will be that much harder to get academic docs to sign on as putative authors on ghostwritten manuscripts?

AMA CEJA Proposes Strong Policy on Medical Education

One of the unfortunate elements of organized medicine's response to pharamceutical industry influence over medical practice, to date, is the tepid ethical guidelines proposed by groups like the AMA, that could be read as trying to prevent the most embarrassing excesses while leaving the status quo intact. This may be changing, as the AMA's Council on Ethical and Judicial Affairs is now proposing a set of recommendations on medical education, specifically, which appropriately joins the reasonably strong statements recently put forward by the AAMC Task Force (http://brodyhooked.blogspot.com/2008/04/aamc-has-spoken-more-or-less-pharm-free.html; see comments for arguments that ther AAMC statement is not as strong as it should be):

http://www.ama-assn.org/ama1/pub/upload/mm/471/ceja1-2.doc

The principal recommendations are worth quoting in full:

• Individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations (including state and medical specialty societies) must not accept industry funding to support professional education activities. Exception should be made for technical training when new diagnostic or therapeutic devices and techniques are introduced. Once expertise in the use of previously new devices has developed within the professional community, continuing industry involvement in educating practitioners is no longer warranted.
• Medical schools and teaching hospitals are learning environments for future physicians at a critical, formative phase in their careers and have special responsibilities to create and foster learning and work environments that instill professional values, norms, and expectations. They must limit, to the greatest extent possible, industry marketing and promotional activities on their campuses. They have a further responsibility to educate trainees about how to interact with industry and their representatives, especially if and when trainees choose to engage industry in varying capacities after residency and fellowship training.
• The medical profession must work together to identify the most effective modes of instruction and evaluation for physician learners. It must then more efficiently develop and disseminate educational programming that serves the educational needs of all physicians. The profession must obtain more noncommercial funding of professional education activities.

And one passage in the body of the report was especially music to my ears: We are not convinced that attempting to manage industry influence in professional education is a prudent use of resources. Rather, avoiding the influence altogether is essential to ensuring the integrity of professional education. Avoiding influence-creating situations altogether is effective, simple, and does not place the burden of sustaining objectivity entirely on individual physicians.

The current word on the street is that some members of CEJA are worried that when this report goes to the AMA House of Delegates next month, the champions of the Pharma gravy train will take strong measures to eviscerate it while few defenders of the report will appear. How the AMA House of Delegates and leadership responds to this report will tell us a lot about whether the winds are shifting as much as some recent events would seem to signal.

Now, of course, if CEJA would only go back and write similarly strong language about the average medical practitioner's relationship with Pharma--or is that asking way too much of what the AMA could stomach?

Must Read Paper of the Month: Is COI a Red Herring?

The "must read" paper of the month is a short commentary by David Healy in World Psychiatry:

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=17342217

Healy is responding to a paper by Fava that ordinarily one would expect to receive approval from critics of industry and medicine's too-cozy relations with it--calling for reforms to correct current conflicts of interests that are rampant in psychiatric research (as well as all other specialties):

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1805729

Healy, however, never seems to go in the front door if climbing in the basement window will serve; so he takes issue with the entire question of whether what is the problem with shoddy, misleading research in psychiatry is conflict of interest at all. He notes that if you in fact adhere to the scientific method, then you should be able to have several dozen major conflicts of interest and still come up with an experimentally plausible answer. Over the centuries, for instance, that has allowed scientists of all different religious persuasions and degrees of religious fervor nevertheless to discover scientific conclusions that disagreed with religious dogma.

If conflict of interest is not the real problem in the current morass of suppressed data and spun results, then what is? Healy suggests that it is really simple: the industry-sponsored studies are not science at all and so do not adhere to the scientific method. He uses the SSRI antidepressant track record as his case in point. The "science" supposedly showed that SSRIs are safer than the older antidepressants and at least as effective; but now we are realizing that once we eliminate the company spin, SSRIs are hardly effective at all and have many major adverse effects. It is to our shame, Healy charges, that we in medicine never figured this out. Had journalists and lawyers not gotten on the case, the shenanighans with the data would never have been revealed.

I realize that when all is said and done, this may be nothing more than semantics, but I still think that Healy's piece is a great read.

Striking a Nerve: The Unbranded Expert Campaign

Some unanticipated consequences of an effort by two journalists to share the names of medical experts who have no financial ties to industry illustrates a few fascinating features of the present state of Pharma affairs.

This whole thing started when Jeanne Lenzer and Shannon Brownlee (full disclosure--as a result of sharing info on a number of stories and projects regarding the drug industry, I have become friends with both of them) asked all of us in their Rolodex whether we would be willing to have our names listed as "experts" (in whatever field) who had certified that we had received no industry support or payments or other bribes in the past 5 years. They had gotten tired of the industry claim that all the really good docs in the US, who actually know what they are talking about, are paid Pharma consultants. What eventually happened with this list is described in an article the two journalists wrote for Slate: http://www.slate.com/id/2190775/.

At this point two odd things happened that Lenzer and Brownlee say they had not anticipated.

First, the media when crazy over their list. You would have thought that the media were all chocaholics and discovered that Lenzer and Brownlee had the last Hersey bar on the face of the earth. Everyone and his duck wanted a copy.

Among those who wanted copies were a number of sources very close to industry. Lenzer and Brownlee have, at least for now, restricted the list to their fellow journalists, in part because that was all those of us on the list signed on for. But now industry folks are demanding to see the list and making threats, veiled or otherwise, of subjecting all the people on it to independent scrutiny to see whether we are what we claim to be. One accusation has been that we are all a bunch of whores for plaintiff's attorneys who help concoct baseless lawsuits against the noble and blameless drug companies, and that conflict of financial interest has not been disclosed. The result has been some ad hominem attacks against Lenzer and Brownlee on industry-friendly blogs (such as http://www.pointoflaw.com/archives/2008/05/the-shannon-brownlee-and-jeann.php and http://drugwonks.com/ on which you have to scroll down some to find the relevant entry). Lenzer and Brownlee have also had some defenders against these attacks, such as http://www.furiousseasons.com/archives/2008/05/slate_responds_to_the_infinite_minds_criticism.html and http://fray.slate.com/discuss/forums/post/1242630.aspx .

I think on the one hand that trying to keep this list a secret was probably a poor strategic move. On the other hand I am reminded of an ugly incident that pretty much ended the academic career of one of my family medicine colleagues many years ago. This particular fellow worked on the faculty of a medical school in a tobacco-growing state and had the questionable judgment to do some research on the affect of cigarette advertising on children. He chose to study the infamous Joe Camel ads in which a cartoon character peddled cigarettes, and showed quite conclusively that contrary to the claims of the company, the actual impact of this ad fell squarely on children. The tobacco company's response was to claim that his research was flawed; to demand to recalculate his statistics; and to demand in a FOIA suit that he release the names of all his survey respondents (who had all been promised confidentiality as part of the consent for the research). The worst outrage occurred when the medical school, bowing to state political pressure, elected to side with the tobacco company against their own faculty member. In hindsight the company had no intention of doing any real data analysis. All they wanted to do was to send a highly chilling message to the research community--don't mess with us. I suspect a chilling effect of this sort is exactly what the industry is seeking here by demanding the infamous list.

The point in all this, as Lenzer and Brownlee shared in an e-mail, is that the industry appears to feel threatened by this list in a way that is quite unprecedented and unexpected. How and why that is so is worth pondering. As an erstwhile member of The List, I can only repeat the words of our highly popular President: bring 'em on. Like that highly popular President I might also regret those words in the not too distant future.

"Brilliant Sleaze" Award Goes to Pfizer's Heart Risk Calculator

In a previous blog entry, http://brodyhooked.blogspot.com/2008/01/alleged-off-label-lipitor-marketing.html, I mentioned the whistleblower suit filed on behalf of Dr. Jesse Polansky against Pfizer, relating to alleged off-label marketing of Lipitor. In that earlier post I alluded to risk calculators as one part of the Pfizer Lipitor marketing strategy. When I first wrote the post, based on my reading of the complaint in the suit, I admit to not having understood very well just what some of the allegations were. Now that I have had some further correspondence with Dr. Polansky and others who know more about these things, I can see that I failed to report what is actually an extremely clever (and if true quite slimy) example of marketing winning out over science.

This gets pretty intricate so see if you can follow me here.

The current cholesterol treatment guidelines (written by a group of experts, most of whom have serious conflicts of interest with manufacturers of statins) depend a good deal on the physician’s ability to assign to each patient a risk level for future heart attacks or other cardiovascular events. Here are four risk group—high, moderately high, moderate, and low—each with its own cutoff level of LDL. That is, the higher the risk group you are in, the lower the level of LDL you should have in your bloodstream, before a physician recommends to you that you should take a statin. Bottom line—drugmakers will sell more statins (like Pfizer’s Lipitor) if somehow more patients can be nudged over from a lower risk classification into a higher one.

Now, for reasons I have covered in previous posts, this entire theory of when statins are good for you is probably deeply flawed, and as a whole shows how industry marketing has come to dominate science to an embarrassing extent. But for present purposes ignore all that. Imagine that the guidelines actually represent good science. The only remaining issue that concerns us is—did we accurately classify the individual patient as being high or moderate or low risk? Suppose that at certain risk level, the guidelines say you should take a statin if your LDL is over 130; and at a different risk level, the guidelines say you should take one if your LDL is over 100. We will not ask any more if there is evidence that patients with those numbers get any real benefit from statins. All we will ask is whether the patients were correctly placed in the given risk category.

It appears that the NIH-based National Cholesterol Education Project (NCEP) came up in the past with two versions of a heart-attack risk calculator, based on the Framingham data. One is a computerized calculator that lives on an NIH website. This calculator relies on continuous variables and so provides an accurate assessment of heart attack risk.

The other NCEP calculator is a paper-and-pencil calculator, designed for docs who are less computer savvy. The paper calculator classifies patients by a yes/no algorithm rather than by continuous variables, and so without boring you (or me) with all the math, it turns out to misclassify a number of patients as high-risk who are actually moderate-risk. It appears that the paper calculator does not misclassify any patient downward by mistake, only upward in terms of risk level. So in effect the paper-and-pencil NCEP calculator does exactly what a company like Pfizer would like it to do, if the goal is to increase Lipitor sales.

Now, Pfizer could have at this point simply thanked its lucky stars and kept quiet about all this, but that would not be an intelligent marketing plan by today’s standards. So what Pfizer (according to Dr. Polansky) proceeded to do was a very complicated trick. It placed a computerized risk calculator on its Lipitor website. It labeled the calculator as being the same as the NCEP calculator, thus disarming any possible suspicion that the average doc might harbor about using a drug-company-supplied device. But the Pfizer calculator is not the same as the NCEP computerized calculator (the accurate one). Rather, the Pfizer on-line risk calculator exactly emulates the NCEP paper-and-pencil calculator, the one that regularly and routinely misclassifies patients as high-risk and therefore needing statins at lower LDL levels. (By contrast, AstraZenica and Merck have Framingham risk calculators on their websites, and those match the more accurate NCEP computerized calculator—suggesting how much extra work the Pfizer programmers had to go through to get their computerized calculator to act like a paper-and-pencil one.)

Dr. Polansky has done some preliminary number-crunching (he tells me he is working on more precise figures) that shows that if the less accurate calculator were universally used, the net result would be extra millions of patients who would be placed on statins, who really ought not to be (even according to the flawed “science” that says they need them at all).

It appears that Pfizer, not content with its coup so far, has worked hard to get its version of the computerized calculator distributed to docs in the form of PDA programs, and distributed by other on-line information sources, but on these details I remain fuzzy.

Dr. Polansky has lodged complaints and queries with people at both NCEP and Pfizer about these matters. Basically, no one at either place seems to think there is any problem. NCEP didn’t initially seem bothered that its two calculators gave different answers and that the average doc would remain clueless that this is so. (After being badgered, NCEP did admit that maybe some sort of warning notice should be added.) NCEP also seems unconcerned that a commercial firm would deliberately misuse NCEP-created materials for its own marketing advantage, while leaving NCEP accountable for the results.

Now, I am not sure whether this ploy gets a brilliance award or a sleaze award, so I will grant it (if all the facts turn out to be as alleged) a “brilliant sleaze award.”