Art Caplan on the New PHRMA Statement on Gifts: Nonsense on Stilts

The movement, begun at Penn, to restrict access to sales representatives and gift-giving behavior on academic health center campuses and facilities has triggered a surprising response from PHARMA. Basically they are arguing that a well-trained sales force has a key role to play in educating physicians about drugs and devices and that sometimes this can and should involve free meals.

I disagree. Sales reps do not have the background or the training to provide sound advice to physicians. They have a background in marketing and selling products--the science of which I would doubt they understand in any real way. I am surprised to see this unconvincing rationale come forward and hope that it will be a tiny speed bump in the effort to minimize the influence of marketing and sales people at academic medical centers, hospitals, and doctor's offices.
- Art Caplan

Windows [on] Nigeria: Is Bioethics' New Benefactor Conflicted?

Where there is money there are conflicts. Accepting money from the Gates Foundation carries ethical consequences, as noted in the LA TImes:

Ebocha, Nigeria — Justice Eta, 14 months old, held out his tiny thumb. An ink spot certified that he had been immunized against polio and measles, thanks to a vaccination drive supported by the Bill & Melinda Gates Foundation.

But polio is not the only threat Justice faces. Almost since birth, he has had respiratory trouble. His neighbors call it "the cough." People blame fumes and soot spewing from flames that tower 300 feet into the air over a nearby oil plant. It is owned by the Italian petroleum giant Eni, whose investors include the Bill & Melinda Gates Foundation.

Justice squirmed in his mother's arms. His face was beaded with sweat caused either by illness or by heat from the flames that illuminate Ebocha day and night. Ebocha means "city of lights."

The makeshift clinic at a church where Justice Eta was vaccinated and the flares spewing over Ebocha represent a head-on conflict for the Gates Foundation. In a contradiction between its grants and its endowment holdings, a Times investigation has found, the foundation reaps vast financial gains every year from investments that contravene its good works.

In Ebocha, where Justice lives, Dr. Elekwachi Okey, a local physician, says hundreds of flares at oil plants in the Niger Delta have caused an epidemic of bronchitis in adults, and asthma and blurred vision in children. No definitive studies have documented the health effects, but many of the 250 toxic chemicals in the fumes and soot have long been linked to respiratory disease and cancer.

"We're all smokers here," Okey said, "but not with cigarettes."

The oil plants in the region surrounding Ebocha find it cheaper to burn nearly 1 billion cubic feet of gas each day and contribute to global warming than to sell it. They deny the flaring causes sickness. Under pressure from activists, however, Nigeria's high court set a deadline to end flaring by May 2007. The gases would be injected back underground, or trucked and piped out for sale. But authorities expect the flares to burn for years beyond the deadline.

The Gates Foundation has poured $218 million into polio and measles immunization and research worldwide, including in the Niger Delta. At the same time that the foundation is funding inoculations to protect health, The Times found, it has invested $423 million in Eni, Royal Dutch Shell, Exxon Mobil Corp., Chevron Corp. and Total of France — the companies responsible for most of the flares blanketing the delta with pollution, beyond anything permitted in the United States or Europe.

-Art Caplan

New England Journal, Conflict of Interest and Amgen

Quite a battle has broken out over the decision of the NEJM not to publish an editorial by Robert Steinbrook MD which is highly critical of the ways in which Amgen's Epoetin is prescribed in the U.S. There are no agreed upon maximum levels for hemoglobin and it appears as if Epo is being over prescribed at bigger than necessary doses by the for-profit dialysis industry. Steinbrook's editorial was published in the Lancet. Questions also have arisen about why the Journal chose to have Julie Ingelfinger write an editorial to substitute for Steinbrook's when she has close ties to the NKF--an organization that receives a significant percentage of its funding from Amgen.

It is still very clear that the management of conflicts of interest for universities, journals, academic health centers and even bioethics centers remains conflicted with no consensus on mimimal rules or about what constitutes a conflict. The academic and journal communities would be well-served in the coming year to convene a blue-ribbon panel to write a report on COI that might serve as the starting point for addressing the complex questions involved. - Arthur Caplan

Well, NIH Doesn't Pay a Lot

So P. Trey Sunderland III, leading NIH psychiatric researcher, earned $508,050 from Pfizer while working for NIH.

NIH Department of Transfusion Medicine Director Harvey G. Klein

This is the LA Times major story about what, if it is true, constitutes a significant conflict of interest for an NIH administrator, namely Harvey Klein:

Confidential income disclosure documents that the NIH recently surrendered to the House Energy and Commerce Committee and other records examined by the Los Angeles Times show that from 1999 to this year Klein received $240,200 in consulting fees and 76,000 stock options from five blood products companies. Klein acknowledged in written responses for this article that several other firms also had paid him fees; he said that he properly reported the compensation to the NIH.

While taking industry's money and also working for the government, Klein helped shape policies and practices that directly affected his industry clients and patients. He participated as an expert at dozens of federal meetings that focused on uses of new blood- related products but did not publicly acknowledge his role as a paid consultant to any company, records show. Other experts did so voluntarily.

Klein also wrote an article for a major medical journal whose editors now say they would not have published if they had known about his company ties.

Editorial ethics groups including the Council of Science Editors' and the World Association of Medical Editors (on both of which I serve) have just ramped up deliberations on this sort of conflicts of interest, but never did any of us imagine that the disclosure of information regarding conflict of interest within the NIH would reach this far or go this high. It seems likely an audit of publications by NIH scientists will be forthcoming. - GM

Lose Reputation Now, Ask Me How

Nobel Prize winner Louis Ignarro, who won the prize in medicine, "endorsed a diet supplement for the heart sold by Herbalife International Inc. in exchange for royalties and then touted the ingredients in a scientific journal, without disclosing his financial interest to the publication,"according to Bloomberg.

The supplement company, based in the Cayman Islands, which rakes in so much money (2003 revenue of $1.16 billion) that it could afford to pay the small company Ignarro formed to consult Herbalife on a supplement (comprised of ingredients that Ignarro discussed in his article) roughly $500,000. Herbalife is in the midst of a public offering, in which it is attempting to raise $193 million, so the publication was well-timed indeed for its efforts. The supplement is supposedly capable of significantly reducing the risk of heart disease even without exercise.

"Ignarro, 63, is the featured speaker in a one-hour Los Angeles based-Herbalife promotional video in which he claims Niteworks protects against heart disease, strokes, Alzheimer's and other diseases." You have to wonder if they watch Herbalife infomercials in Sweden?

Cleveland Clinic's Top Heart Surgeon Profits from Criticizing Vioxx?

The Cleveland Plain Dealer follows a trail set out by David Blumenthal, director of Mass General's Institute for Health Policy. Eric Topol, one of the best heart docs in the world, if not the best, and long the face of innovation (and the most significant backer of bioethics) at Cleveland Clinic, has been researching Vioxx for three years:

Dr. Eric Topol, the Clinic's top heart doctor, published studies as early as 2001 warning that Vioxx and a similar drug, Celebrex, now made by Pfizer Inc., posed potential risks to some patients. The drugs, called cox-2 inhibitors, were instant hits when they came on the market in the late 1990s because they are easier on the stomach than aspirin and other painkillers.

The Plain Dealer - following details published in this week's Fortune magazing - describes Topol's subsequent hiring as biomedical advisor by a risky hedge fund called Great Point Partners LLC. (What is a hedge fund? It is what it does, which is "sell shares on the belief that they will lose value, then buy them back when they are cheaper.") What happened while Topol advised the hedge fund?

Fortune magazine reports in its Dec. 13 issue that Great Point bragged in a recent letter to investors that the hedge fund made a killing by "shorting" Merck stock -- that is, selling shares on the belief that they would lose value, then buying them back when they were cheaper. Since Merck pulled Vioxx off the market, the company's shares have dropped 37 percent.

Great Point said Topol's warnings about Vioxx were one reason the fund was on "the right side of that situation." But Topol took issue with the Fortune report, saying in a written statement that his views on Vioxx were well known long before he signed on with the hedge fund, that he did not know the fund was trading Merck stock, and that he had no personal investment in the fund.

Topol wrote to Fortune refuting this and other accusations of conflict of interest made the magazine:

Topol took issue with the Fortune report, saying in a written statement that his views on Vioxx were well known long before he signed on with the hedge fund, that he did not know the fund was trading Merck stock, and that he had no personal investment in the fund. Topol said he quit the advisory board in October "because of the concern about an appearance of a conflict of interest, even though there was none." He said Great Point was paying him $12,000 a year to evaluate new technologies for treating heart disease.

Blumenthal stops short of describing Topol's activities as conflicted, and predicts more expert-as-investment-advisor behavior in the future. There's no indication in the stories that Merck revealed Topol's role, and Certainly Fortune could have dredged it up from the fund's press release, but you have to wonder how many people are going to step up to advise companies on matters of profits when the backlash can be this strong.

If Eric Topol in fact earned $12,000 for advising a little hedge-fund company about the state of biomedical technology, including his view about Merck, which was already well published, one would be hard-pressed to accuse him of trying to profit. Topol could have made a small fortune hedging Merck himself, in someone else's name to cover his tracks. Would he really be stupid enough to take a tiny fee instead, in full public view? Unless there is much more to this story than is reported, it looks like a fancy way to tar the biggest critic of a certain pharmaceutical company... (Wait, should I have written that? Maybe a Philadelphia Inquirer writer will 'discover' that I own a retirement mutual fund with $14 worth of Merck stock in it...) - GM

Medical Journal Editors Sin Too

For years the World Association of Medical Editors' Ethics Committee has produced rules about what sort of things editors should and should not do. This week, the Committee on Publication Ethics, a British Medical Journal-run publication ethics group, launched its own code for ethical conduct. British Medical Journal today reviews the new code and what it might mean. The code deals with lots of things but what really matters is its focus on conflict of interest.

Conflicts of Interest Everywhere

The Lancet is engaged in scandalous destruction and obfuscation of data on the relationship between abortion and breast cancer. So goes the story on Businesswire, in which an editorial by Ed Furton in Ethics and Medics journal is credited with making the charge. The story announces the finding by the ethics journal as though Lancet has been caught in a real moral morass. But ... Ethics and Medics, it turns out, is a publication of the National Catholic Bioethics Center, and their editorial was highlighted by the Coalition of Abortion and Breast Cancer. Now who would guess that the charges in the editorial involve the claim that the Lancet and cancer research community in general are deliberately "corrupting scientific research examining the abortion-breast cancer link."

JAMA is running a great set of articles on the relationship between ethics and the bioscience business; Psaty and colleagues review "Potential for Conflict of Interest in the Evaluation of Suspected Adverse Drug Reactions: Use of Cerivastatin and Risk of Rhabdomyolysis," and Brian Strom replies. Fontanarosa, Rennie and DeAngelis discuss drug withdrawals in an accompanying article. Jeremy Sugarman reviews Margaret Eaton's book Ethics and the Business of Bioscience. (subscription required).

EPA Criteria for Pesticide Dangers are Unethical and Flawed

Flawed Pesticide Studies Using Human Subjects Could Result In Higher Allowable Exposures For Both Children And Adults, trumpets perhaps the most comprehensive review ever of a set of studies at the EPA, published in the American Journal of Public Health. The study:

found the studies flawed by conflict of interest, failure to meet ethical standards established by the Declaration of Helsinki, unacceptable informed consent procedures, inadequate statistical power and inappropriate test methods and end points.

Failing to Reveal Conflicts of Interest

A Sunday story that wasn't picked up very much by Marilynn Marchione does a great job of ransacking the current wave of denials concerning how conflict of interest affects physicians engaged in drug consultation and in other ways affiliated with drug companies.

Medtronic (Again)

A Des Moines hospital employee has filed suit over alleged Medtronic pacemaker kickbacks in excess of $1 million. This is one of the bigger, clearer conflict of interest and kickback scandals of the past five years. Miles is quoted.

Limits on Drug Financed Physicians

ACCME is pushing a plan to simply shut out physician instruction of drug company sponsored CME. It is a complex plan with room for loopholes but reflects an extraordinary push to get more accurate information about potential problems associated with inappropriate off label uses of pharmaceuticals. Norm Fost is quoted.

NIH Employee Payment Policy (COI)

The Los Angeles Times story about the NIH response to conflict of interest includes an Institutes-wide ban on outside payments to employees. Bob Koepp brought this to the attention of MCW readers.