The AAMC Has Spoken: The (More or Less) Pharm-Free Medical Center

A task force of the Association of American Medical Colleges today released its report on "Industry Funding of Medical Education." See Gardiner Harris's report for the New York Times at http://www.nytimes.com/2008/04/28/us/28doctors.html?_r=1&ref=health&oref=slogin, and the report itself at http://www.aamc.org/research/coi/industryfunding.pdf.

We'll turn in a minute to the details, but first the news headlines. What seems most astonishing about the report is that several highly placed CEOs of major drug and biotech firms served as members of the Task Force, which was chaired by Dr. Roy Vagelos, former Merck CEO (albeit a CEO who has been widely quoted as dismayed by what commercialism has done in recent years to his once-proud company). Nonetheless the report recommends the cessation or severe curtailment of most commonplace industry marketing practices. True, several of the company guys dissented from one or another aspect of the report. But taken as a whole, their dissents were relatively tame and peripheral. It's not clear to me whether these CEOs truly believe that when looked at in the cold light of dawn, many common industry practices are indeed indefensible; or whether they figure that with all the PR hits the industry is now taking, the better part of valor is to head for cover.

Now for the details (based on the executive summary):

• Industry activities that undermine professionalism need to be eliminated.
• Trainees need to be educated as to the challenges to professionalism posed by industry interactions (and a follow-on group should specifically address educational methods and objectives).
• Academic medical centers should try at least by persuasion if not by enforcement to make the rules binding off-site and off-hours as well as on the campus itself.
• No gifts from industry to individuals. Food is a gift, unless a meal is part of an audited and prescribed CME activity.
• Drug samples should be centrally controlled if used at all.
• Drug reps on campus by appointment only, and not in patient care areas.
• No drug rep contact with trainees unless directly supervised by faculty.
• Device reps in patient areas only if needed for direct teaching or adjustment of device use.
• Centers need to carefully audit that CME programs meet ACCME guidelines.
• Faculty participation in industry speakers' bureaus should be strongly discouraged.
• Industry may provide educational grants for trainees only if medical center has full control over selection of recipients.
• Ghostwriting is prohibited.

Quibbles? There are several places where some wiggle room is allowed, where I personally would have preferred a strict "no," pure and simple. As the report focuses on "education," nothing is said about the biggest temptation for faculty and institutions alike--industry research grants to do drug studies.

Is this document important? Let me use my own home base as an example. The University of Texas Medical Branch is now the proud owner of a very strict conflict-of-interest policy, courtesy the University of Texas System governance structure, which dictated to us that such policies would be adopted at all UT health science centers, pronto. The policy was just recently approved and is to go into effect July 1. The Provost, very appropriately in my view, promised the faculty opportunities between now and July 1 to voice their views on the policy and perhaps to amend it. The view in the trenches among my colleagues, as voiced at previous forums on this topic, tended to favor laissez-faire on the matter of drug company gifts and payments. I don't believe that most of the faculty even know yet about the new policy, and I was looking for a convenient foxhole to hide in when the shells started flying. But now, in the face of this new AAMC policy statement, I have a hard time seeing how any faculty member, who would wish to loosen the strictures of the policy, would really have a leg to stand on. So yes, I think this is an important development. Let's meet up in 5 years and see how much has changed as a result.

Maybe the Drug Companies Should Clean Up This Mess

In keeping with the previous post on the woes of the underfunded FDA, the New England Journal (which no doubt takes their cues from this blog) ran two commentaries on the FDA's ability to guarantee the safety of the U.S. prescription drug supply in its April 24 issue. Mostly this was going over well-known ground, but I was struck by the suggestion made by Dr. Alastair J.J. Wood of Cornell. (It's my understanding that Dr. Wood was widely thought, in the past, to be the most logical person with the greatest relevant expertise to become the Commissioner of the FDA, and was not given that job because he was insufficiently pro-business. If true, that's a deficiency that Dr. Wood appears now to be eager to remedy, as NEJM states that he's "managing director of Symphony Capital" and also has received lecture fees from PhRMA.)

However, in comments that I doubt were paid for by the drug industry, Dr. Wood offers a counterpoint to the general clamor for FDA accountability for allowing poisonous chemicals to enter the U.S. drug supply via China. He offers the refreshing proposal that the drug companies should instead be held responsible for this and the FDA should basically admit that it has no control over these matters. After all, Dr. Wood reminds us, why are these shady Chinese companies in the loop at all? It was the American or global drug companies' own business plans that led them to decide that they could make a fast buck by outsourcing their chemical supply sources. Since they presumably made extra profits by buying cheaper ingredients for their drugs, they can reinvest some of those earnings in taking whatever steps are needed to assure quality and safety of the drugs that they peddle--or else be held fully accountable for foisting poisons on the American public.

As explained in HOOKED, this shows the ambivalent relationship that is set up by the phenomenon of "regulatory capture" of a Federal agency by the industry it is supposed to regulate. The drug companies are walking a very fine line. They want the FDA to be rendered sufficiently toothless as to be unable to take any actions that cause any inconvenience or lowered profits for them. But at the same time they want the FDA to appear powerful and threatening enough so that they can turn around and blame the FDA oversight process whenever a scandal arises like tainted Chinese-made heparin. Ditto for the present efforts of the industry to support FDA rules changes that would allow companies to market drugs off-label by circulating reprints from medical journals (based on the assumption that the FDA stringently regulates this process so that no false information could ever get through), and to convince the U.S. Supreme Court that they should be shielded from any legal liability in relation to any drug that has been FDA approved (again assuming that the FDA approval process is so stringent that the public needs no additional safeguards).

Wood AJJ. Playing "kick the FDA"--risk-free to players but hazardous to public health. N Engl J Med 358:1774-75, April 24, 2008.

You Heard It From the Top: FDA Can't Function

As a rule there is an infallible way of committing suicide as an agency chief in the executive branch of the US government. Just go testify before Congress that your budget is inadequate, when the budget has been determined not by Congress but by the White House. To do so is to tell Congress that your boss is a moron.

On the other hand, if the boss is a lame duck with a popularity rating far down in the toilet, what do you have to lose?

The first agency head to ventilate in this fashion was FBI head Robert Mueller. Now, FDA director Andrew von Eschenbach has joined in.

Depending on who he was talking to, von Eschenbach put a little smiley face or frowney face on his comments. One version was that the agency simply lacked the funding needed to carry out its mission. Then the gussied-up version was that the agency is OK for now but cannot maintain its edge in the future.

But the basic story is that you heard it right from the top--the FDA cannot assure the public reasonable safety in its food or drug supply because the budget requested by the White House is insufficient. In a climate when Reps and Dems apparently cannot agree on anything, there was bipartisan support in the Senate Appropriations subcommittee for increasing the budget of the FDA.

Harris G. Panel's bipartisan view: F.D.A. is underfinanced. New York Times, April 16, 2008; http://www.nytimes.com/2008/04/16/washington/16fda.html?_r=1&scp=1&sq=gardiner+harris+panel%27s+bipartisan+view+f.d.a.&st=nyt&oref=slogin

The Pharma Apologists Are Backing Down

I've previously called attention in this blog to the writings of Dr. Thomas Stossel of Harvard, who appears to be ready to lend his support to the industry propaganda machine. That machine is sorely taxed of late with the Mass. legislature threatening to enact a law banning all gifts (read bribes) from drug reps to docs. So Dr. Stossel and his colleague, Dr. Dennis Ausiello, told the Boston Herald why this is such a bad idea.

You can read the op-ed in its native habitat at:
http://www.bostonherald.com/news/opinion/op_ed/view.bg?articleid=1087609
However, the Herald will not tell you a couple of things you'd like to know, that are listed on the Pharmalot blog: http://www.pharmalot.com/2008/04/massachusetts-docs-to-lawmakers-no-gift-ban/-- like for instance that Ausiello is a director at Pfizer and Stossel is a paid consultant to Merck, with each having several other major interests as well.

As I say, you can read the op-ed for yourself. But I thought that so much of what they say is instructive, that it was worth printing the whole thing below in italics, with my own comments in bold.

Conflicts don’t sicken health care
By Dennis Ausiello and Thomas P. Stossel Thursday, April 17, 2008 Op-Ed
Many discoveries leading to extended longevity and improved life quality originate in Massachusetts clinics and laboratories. But they only benefit our citizens because of the private companies that develop, manufacture and sell medical products.
Therefore, for the Legislature even to deliberate passing a law imposing fines up to $5,000 and jail sentences up to two years on practicing physicians if they accept a pen, pad of paper or slice of pizza from a company representative reflects the success that critics hostile to commerce in general have had in capitalizing on profound misunderstandings of how these companies interface with medicine.
The real intent of these critics goes far beyond food and trinkets, and its true purpose is to curtail strictly or even eliminate all contacts between physicians and private industry. We strongly oppose this agenda.

Good golly gosh. Most of us critics of the medical profession's too-cozy relationships with Pharma thought that we were trying to get rid of financial conflicts of interest, while permitting all sorts of contacts and relationships between the profession and the industry--namely, all those contacts and relationships that did not result in docs lining their pockets with industry cash. We never thought that we were opponents of industry-professional exchange of information--far less that we were opponents of "commerce in general." We are sure grateful to these two perceptive physicians, who obviously know our true motives much better than we do ourselves.

Despite extensive training, physicians cannot know the details of all products, especially new ones. Therefore, company salespersons complement physicians’ information derived from many sources. They tell physicians about a limited range of products about which their employers train them under strict FDA regulations.

If you believe that today, drug reps's spiels to docs are "educational," and that they always adhere to strict FDA regs, then let me sell you some swamp land in Florida. The so-called value of reps's contacts with docs as a way to keep docs informed about new drugs has been so thoroughly trashed in a voluminous literature that no more need be said.

The proposed state gift prohibition aims at the misperception that the company sales representatives use gifts - essentially bribes - to cajole physicians into using company products, and that such use is medically inappropriate and unjustifiably increases costs.
Little evidence supports these concerns.

Well, at least we got them to say the key word, "bribes." As to the assertion "little evidence supports these concerns," read HOOKED.

Federal laws already prohibit bribes and kickbacks between companies and doctors, and other laws encourage whistle-blowing if infractions occur. At the state level, attorneys general enforce these laws. Company representatives providing small gifts or meals to gain access to doctors hardly amounts to bribery or kickbacks.

This drags out the old chestnut about small gifts being too piddly to influence anyone so only gifts over a certain value count. The available research suggests that if anything, the opposite is true.

But to emphasize that physicians and students in the academic institutions where we work want to learn about products because it is good for patients, we support hospital policies that eliminate these practices but not the relationships per se.

Whoa--hold onto your hat. This is a HUGE concession among the pro-industry-entanglement troops. They are willing to admit finally that when you shovel freebies at docs, then the whole exchange takes on an unsavory atmosphere that is not conducive to public trust. That has been the critics' point all along.

Companies certainly use sales forces to encourage product prescribing, and encounters between detailers and physicians demonstrably accomplish this goal.
New brand products are inevitably more expensive than older, especially generic ones, and, in some instances, newer versions may add only incremental value. Deciding in such cases to prescribe older products may be appropriate.

Another huge concession--cheaper generic drugs may be just as good as the latest brand name stuff.

Unfortunately, defining such circumstances is often difficult, if not impossible. Although product prescribing always incurs costs, cost is not the only issue. What is more important is the cost benefit ratio in terms of better health. A good physician follows patients carefully and monitors their responses to whatever products have been prescribed.

Anyone want to argue with this? I don't.

Under the current system of product information, drugs are not even close to the top drivers of health care costs. Drug price growth in 2007 was 1.4 percent, and prescription medicines account for only 10 percent of health care spending.

That's true too, if largely besides the point. If we can get a handle on a smaller part of health care costs, while the larger portion is simply out of reach, why not focus on what we can control?

We believe that the best approach to optimize cost effectiveness of product prescribing is to promote more, not less, interaction among all stakeholders involved in health-care delivery, including company marketing reps.

That all went by me pretty fast. "Interaction among stakeholders" sounds like a great general propostion. So exactly how did we segue from that to drug reps? Are Ausiello and Stossel claiming that of all the folks who work for drug companies, the ones that it's most rewarding and useful for docs to engage with is the reps? The folks that have been shown on many occasions often not to have any science background before being hired by the companies; to be chosen primarily for good looks and nice personalities rather than knowledge (remember the former cheerleaders); and whose training and bonus incentives focus most of all on sell, sell, sell?

The language of the Legislature’s proposed anti-gifting bill is both severe and vague, inviting inquisitors and individuals with personal grievances to harass physicians involved in a large variety of potentially constructive research and educational activities. Such harassment will inevitably inhibit appropriate industry support of these legitimate activities.
The state should be cautious about embarking on the radical course epitomized by the law under consideration. It threatens to dismantle a system that has served us well, and is deeply disrespectful of physicians and companies alike.

"A system that has served us well"--as HOOKED and numerous similar books and articles have shown, the system that brought us 140,000 excess MIs from Vioxx, just to name the most obvious recent scandal. If the system has served us so well, from whence comes all the political pressure, at long last, to change it?

JAMA To Pharma and Its Allies: Enough Already

As most anyone who read a morning paper today now knows, the current issue of JAMA contains two articles and an editorial based on documents released as part of the Vioxx lawsuits against Merck, showing evidence of ghostwriting and data manipulation. Little of this will be new to readers of HOOKED or this blog. Perhaps the most newsworthy point was the tone of JAMA's editorial, which might be describe as, "We're mad as hell and we're not going to take it any more." Or, as the editorial itself stated, "[Profound influence of the pharmaceutical and device industries over medical practice, education, and research] has occurred because physicians have allowed it to happen, and it is time to stop."

In news accounts Merck tried to minimize the damage by objecting that the authors of both papers had conflicts of interest because they had been employed by plaintiffs' attorneys in the lawsuits. (Funny how drug companies think that financial conflicts of interest are so damaging to one's credibility, as soon as the shoe is on the other foot.) JAMA makes no bones about these conflicts, acknowledging that only those involved with the lawsuits would normally have access to these documents in the first place. Just to assure that everything is kosher, JAMA took the unusual step of demanding that all of the original documents on which the authors relied be posted in publicly accessible websites that are referenced in the articles.

Ross et al. dealt with the issue of ghost and guest authorship, comparing correspondence between Merck and several medical communications companies regarding manuscripts being prepared for publication, with the actual publications in medical journals. (This is the same strategy Healy and Cattell employed in the best earlier paper on this topic, which made use of documents released by the Zoloft litigation.) When various drafts of the same article could be compared, they generally showed virtually no changes, thus negating any suggestion by the putative academic authors that they had carefully read and edited the manuscripts supplied for them by the ghostwriters. The practice most noted here, but not much discussed previously, is guest authorship, in which Merck in-house scientists wrote the paper but then added the names of academic scientists, often listing the academic as first or second author. Apparently, what has changed in recent years is that journal policies make it harder and harder completely to concal company sponsorship; indeed most of these articles disclose Merck funding. So the Merck scientists are listed openly as co-authors, only farther down the list, and the putative academic authors (who acually add little or nothing to the paper) are slipped in at the top.

Another tidbit in this paper is what the putative academic authors are paid for the use of their names. Ross et al. found fees of $750 to $2500 documented. In writing HOOKED, I could not find documented evidence of any fees of this sort greater than $1000, though when I mentioned that figure to several people closer than I am to the journal "biz," I received eye-rolls suggesting that I was on the low side. So it's nice to know what the going rate is for selling your integrity as a scientist.

Psaty and Kronmal recalculated the mortality rates from heart disease in two studies in which Merck tried to show that Vioxx would be good for preventing or reversing Alzheimer's--which flopped because it either did nothing or worsened the disease. They show that in both the published papers and in data submitted to the FDA, Merck managed to under-report the actual risk of heart disease deaths. Now that we know what we know, some of the data reported in the papers should have set off warning bells among journal editors and reviewers-- such as: "There were no drug-related deaths during the study. Non-drug related deaths occurred in 11 patients (9 in the rofecoxib group and 2 in the placebo group) while taking the study treatment or within 14 days of the last dose." Let's see--there were no "drug related" deaths, and purely by coincidence, more than four times as many patients who were taking Vioxx died compared to those taking placebo? Uh huh.

The editorial by DeAngelis and Fontanarosa lists a number of proposed reform measures, many of which are rather self-serving because they claim that if only all medical journals had the same stringent editorial policies as JAMA does, this sort of thing would not happen. The last in the list might easily be missed: "Individual physicians must be free of financial influences of pharmaceutical and medical devicde companies including serving on speaker's bureaus or accepting gifts." In other words, JAMA has belatedly come out in favor of the No Free Lunch pledge, AMSA's Pharm-Free campaign, and the National Physician's Alliance Unbranded Doctor campaign.

Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 299:1800-12, April 16, 2008.

Psaty BM, Kronmal RA. Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation. JAMA 299:1813-17, April 16, 2008.

DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical science: the adverse effect of industry influence. JAMA 299:1833-35, April 16, 2008.

Healy D, Cattell D. Interface betweem authorship, industry and science in the domain of therapeutics. Br J Psychiatry 183:22-27, 2003.

Latest Integrity Awards: NY Times Profiles Three Newly-Pharm-Free Academics

It's been a while since this blog issued an integrity award, so I am happy to confer that honor on Drs. Peter Libby (cardiology, Brigham and Women's Hospital); Kelly Brownell (obesity medicine, Yale); and Eric Winer (breast oncology, Dana-Farber Cancer Institute). They were profiled in today's New York Times: http://www.nytimes.com/2008/04/15/health/15conf.html?_r=2&ex=1365998400&en=af5a4553709a6ccb&ei=5088&partner=rssnyt&emc=rss&oref=slogin&oref=slogin

Each previously accepted speakers' and consulting fees from the drug industry, but recently decided that the stigma and the threat to their own reputations and objectivity were too great and began to accept no payments for contacts with industry. They varied in their levels of ethical commitment to this course; Dr. Brownell was eloquent in speaking about his own fears of loss of objectivity, while Dr. Winer indicated some lingering resentment that changing social attitudes about Pharma money had forced him to have to make this decision.

The changing attitudes are the main news story here. Added to news earlier in the week of companies offering "voluntarily" to release information on gifts and payments, the fact that these highly placed academics, who in the past were happy to take industry money, now feel that the wind has significantly shifted, may be some of the best evidence yet that the shift is actually occurring.

Kolata G. Citing ethics, some doctors are rejecting industry pay. New York Times, April 15, 2008.

Fantastic Poem: "Drug Company Dinner"

I recently had the pleasure to present a grand rounds for Summa Health System in Akron, where my host was Dr. Joe Zarconi, who rounded out the panel discussion on Pharma issues by reading the poem below. The poem, as the saying goes, was worth the price of admission. As the poem is available on line (http://www.psychiatrictimes.com/display/article/10168/52371?pageNumber=1), I trust I won't get hauled off by the copyright police if I reprint it here:

Richard Berlin
Drug Company Dinner
Psychiatric Times May 2005 Vol. XXII Issue 6

I dressed in a suit and cashmere coat,
a young man parked my car.
Red-dressed starlets flashed cleavage
and offered me black Beluga caviar
on buckwheat blinis. They sat me at a table
laid out with silver on white linen cloth,
each setting trimmed with an orchid
in a royal blue vase. And I might have heard
someone speak about doses and side effects
before the waiters served sea urchin eggs
arranged on white porcelain shells, circled
with fresh basil and warm tomato puree.
They carried two pound lobsters, rack of lamb,
poured wine into a glass that never emptied,
arranged an oak leaf and beet salad
into a still-life painting, fetched a cheese course
from the farms of France, and finished with chocolate
soufflé, frozen glasses of grappa, and a tray
topped with towers of Belgian truffles.
And a starlet held open my cashmere coat,
the young man returned my warmed-up car,
and I walked outside and breathed the Berkshires
in March, the smells of melted snow and sap
flowing in the pines, and I drove the slick surface
that twists and turns up Lenox Mountain, wondering,
really wondering, how much this night had cost me.

Dr. Berlin is associate professor of psychiatry at the University of Massachusetts Medical School. Dr. Berlin's book How JFK Killed My Father won the 2002 Pearl Poetry Prize and is now in its 2nd printing, published by Pearl Editions.

(Note: Not that I pretend to be a literary critic, but I can see why this dude wins poetry prizes... catch the imagery of the road with its "slick surface that twists and turns...")