Monday, 27 November 2006

Princess Health and  The American Diabetes Association and Its Pharmaceutical Donors. Princessiccia

Princess Health and The American Diabetes Association and Its Pharmaceutical Donors. Princessiccia

The New York Times reported last week about potential institutional conflicts of interest affecting the American Diabetes Association. The Times' article's main focus was on the organization's ties to the food industry, especially to makers of highly caloric food:


SnackWell�s Sugar-Free Lemon Creme cookies have nearly as many calories as some sugar-rich cookies. Yet until recently the box featured an American Diabetes Association logo, advertising the cookie as a 'proud sponsor' of the charity�s efforts on behalf of the nation�s 21 million diabetics.

Foods like the Sugar-Freedom Eskimo Pie and Frosted Shredded Wheat have also sported the American Diabetes Association logo over the years. The companies paid the A.D.A. to be associated with a respected voice for healthful eating. The association wanted the money to finance its uphill battle against a widening epidemic of Type 2 diabetes, which is associated with obesity.
To its credit, the ADA has started to rethink its relationship with the food industry.

But in the last year the A.D.A. began rethinking how it raises money from companies, especially from those whose primary business is selling foods and beverages that are high in calories, even if they have created some sugar-free items.

The group has allowed some food company deals to expire and has turned down millions of dollars in new sponsorships.
However, although it received less attention in the article, what may be a more important issue is the ADA's relationships with pharmaceutical companies (quotes below somewhat re-ordered.)

Though they often present the most difficult choices, food companies represent a small segment of the A.D.A.�s corporate support. Pharmaceutical companies remain the largest corporate contributors, but the guidelines have not affected them as much because the A.D.A. has never allowed its logo to be put on specific medicines.

Others remain concerned about the A.D.A.�s relationships with pharmaceutical companies. Their presence is evident throughout the charity, from its annual convention, which is largely underwritten by drug makers, to its board meetings, where pharmaceutical executives have served on the volunteer committees that set policy.

The A.D.A. says its independence is evident because it has often acted against the interests of the pharmaceutical industry. Last month, for example, a panel it appointed to study how to treat people at heightened risk of developing diabetes decided against recommending the use of higher-priced brand-name drugs.

But critics say the drug industry�s influence can be seen in the A.D.A.�s emphasis on the treatment of diabetics, which often involves drug therapy, over efforts to persuade people to change the way they live so that the disease can be prevented in the first place.

Dr. Peter Lurie, deputy director of the Health Research Group of Public Citizen, the government watchdog group, said the influence of pharmaceutical money can be very subtle.

'The question is what happens in the close calls,' he said. 'If you are at more cocktail parties, if you have more mugs from the company in your kitchen, you are just going to be more receptive.'

A.D.A. officials cited an event from several years ago to illustrate their resistance to such influence. An A.D.A. panel found that antipsychotic drugs could help fuel diabetes. The announcement angered a drug manufacturer, Eli Lilly and Company, a longstanding A.D.A. benefactor that stood to lose hundreds of millions of dollars in lawsuits.

Some A.D.A. officials said they believed the company became so angry it sought to have Dr. Kahn fired, a charge the company denies.

Either way, nothing happened. Dr. Kahn, the association�s chief scientific officer, kept his job.

'Show me one instance where money has caused us to do something that is wrong,' Dr. Kahn said in an interview. 'You can�t.'
One starts to wonder whether there is any large US health care non-profit corporation that does not receive a significant amount of funding from the for-proft health care sector.

It may be very hard to prove such relationships have caused not-for-profit organizations like the ADA to do "something wrong," especially if one demands a scientific level of proof of causation.

On the other hand, a not-for-profit that gets a large amount of money from, say, the pharmaceutical industry might be hesitant to be critical of the industry or its products, or prone to give the industry the benefit of a doubt.

But even such relatively subtle biases could put the industrial benefactor's interests ahead of the not-for-profit organization's own mission.

Large, stable funding streams from commercial firms may be tempting, but not-for-profit leaders must ask themselves if they are worth the doubts they ought to raise.

Sunday, 26 November 2006

Princess Health and  More Fall-Out from Allegations of Faculty Positions Traded for Referrals at UMDNJ. Princessiccia

Princess Health and More Fall-Out from Allegations of Faculty Positions Traded for Referrals at UMDNJ. Princessiccia

The latest development in the mess at the University of Medicine and Dentistry of New Jersey (UMDNJ) produced some interesting analysis in the media. As we have discussed previously, the university now is operating under a federal deferred prosecution agreement with the supervision of a federal monitor (see most recent posts here, here, here, here and here.) We had previously discussed allegations that UMDNJ had offered no-bid contracts, at times requiring no work, to the politically connected; had paid for lobbyists and made political contributions, even though UMDNJ is a state institution; and seemed to be run by political bosses rather than health care professionals. (See posts here, and here, with links to previous posts.) The latest development (see post here with links to previous posts) was that UMDNJ apparently gave paid part-time faculty positions to some community cardiologists in exchange for their referrals to the University's cardiac surgery program, but not in exchange for any major academic responsibilities.

First, the indefatigable Newark Star-Ledger reported that Dr Jerrold Ellner, the chair of medicine at the UMDNJ Newark campus, was put on administrative leave because he and Ronald Pittore, of the school's legal department, "were identified by the university's federal monitor as key figures in UMDNJ's plan to hire at least 18 local cardiologists as part-time clinical assistant professors."

That event inspired a news analysis article in the New York Times. The points it made included,

As New Jersey�s state medical school has been shaken in the past year by disclosures of widespread financial mismanagement, administrators there have repeatedly defended the institution, the University of Medicine and Dentistry of New Jersey, by insisting that the scandals have affected its treasury but not the quality of care for the more than two million patients it treats each year.

But a federal monitor�s recent accusations that the cardiology unit at the university�s main hospital has been paying kickbacks to doctors for referring heart patients have undercut that argument at a time when the school�s future remains in doubt.

The fact that some of the university�s most prominent doctors now stand accused of taking part in an illegal scheme that involved life-or-death medical decisions is likely to further tarnish the school�s image at a time when state officials are deciding whether to merge the institution with Rutgers University and Robert Wood Johnson University Hospital.

Governor Corzine said on Wednesday that charges about the quality of care being affected by the scandal were deeply troubling � 'It�s really disgusting that the culture allowed for this kind of practice' � but added that he had not decided whether to restructure or disband the school.
But other state officials said the latest round of disclosures would only heighten pressure for a merger.

'This just highlights the disaster of trying to salvage what�s left,' said State Senator Raymond J. Lesniak, a Democrat from Union County who is chairman of a panel examining the future of the school. 'Before, the focus was on enhancing the ability to provide education. But now we�re also talking about direct impact on health care and people�s lives.'

On one hand, it is too bad that this analysis appeared in the Times' regional section. Although one would think that a scandal of this magnitude involving the biggest health care university in the US would attract national attention, as an example of the anechoic effect, it has been treated largely as a regional matter.

On the other hand, the analysis recounts some curious ideas about this case.

The first is that a scandal involving top leaders of the health care university had only financial significance, at least until a top physician leader was involved. Underlying this might be an asumption that the managerial and financial sphere of the university is entirely separate from the clinical and academic sphere. But the mismanagement in the former sphere must have sapped resources from the latter. Furthermore, it is hard to believe that clinical and academic personnel did not sense something wrong in the top management, and at least that the focus was more on the personal interests of the top management than the mission of the university. Such a sense would likely at least have dispirited these personnel, and certainly would not have enhanced their performance.

The second curious notion was that the involvement of a top physician-leader somehow signifies that the institution is now irredeemable, and the only remaining choices are to merge it into another institution, or shut it down entirely. This seems to discount, again, all the hard-working clinical and academic personnel who have been laboring to keep things together at UMDNJ together despite the bad behavior by top management. Maybe somebody should talk to this long-suffering group before any irrevocable decisions are made about the structure of the institution. And again, for better or worse, all should remember that health care institutions are made up of many dedicated hard-working people, besides the top managers. Perhaps again the underlying assumption is that somehow imperial top management is indistinguisable from the institution, the notion that "l'hospital c'est moi."

This notion must be discarded in favor of health care governance that is more representative of the relevant stake-holders, as well as more accountable, transparent, and ethical.

Saturday, 25 November 2006

Princess Health and  Bayer's Attempted Suppression of Trasylol (Aprotinin) Data Makes the New England Journal of Medicine. Princessiccia

Princess Health and Bayer's Attempted Suppression of Trasylol (Aprotinin) Data Makes the New England Journal of Medicine. Princessiccia

The latest issue of the New England Journal of Medicine includes an article about Bayer's attempted suppression of data from an observational study of Trasylol (aprotinin). [Avorn J. Dangerous deception - hiding the evidence of adverse drug effects. N Engl J Med 2006; 355: 2169-2171] We had first blogged about this case, based on a story reported in September, 2006 in the New York Times, here. Avorn's comments on the case are notable:

The health care system has a hard time performing drug-safety analyses, in large part because it relies on the pharmaceutical industry to conduct most research on the risks and benefits of medications. It is naive to expect companies to voluntarily fund studies that could sink lucrative products, the FDA lacks the regulatory clout to require them, and despite the $220 billion we spend on drugs each year, we apparently can't find the resources to provide public support for these studies, even if the results could be of great clinical importance and save millions of dollars.

Avorn suggested:

A good start would be to make a national commitment to publicly supported studies of drug risks so that no company could take possession of critical findings for its own purposes. The results of that research could be discussed openly at an annual conference on the risks and benefits of drugs.

In my humble opinion, it does not make sense to let pharmaceutical (and bio-technology and device) companies be responsible for performing relatively unmonitored studies on human subjects to test their own products. One solution would be to put scientists, physicians, and organizations who are not beholden to such companies in charge of such studies. Another would be much more intense regulation of any human studies sponsored by commercial firms.

At least this issue has now come out in the perhaps world's most prestigious medical journal, so it is squarely in front of doctors, other health professionals, and health policy makers.

But I now realize that Avorn's article, and, for that matter, my previous post, both seemed to avoid the issue of accountability of the drug, bio-tech, and device companies who are currently performing (or funding, and then at least partically controlling) studies on humans. So let me correct that omission.

Also in my humble opinion, as long as commercial firms (e.g., pharma, bio-tech, or device) sponsor, and to any extent control studies on human beings, these firms should be held accountable for any failure to disseminate study findings, even if, and maybe especially if the findings are not favorable to their product. Because their products affect peoples' health and safety, suppressing data about their products' adverse effects, or failure to provide beneficial effects is an affront to any patient who might take or be subject to such products. There should be severe negative consequences for any company that withholds such findings.

Wednesday, 22 November 2006

Princess Health and  Cyberonics' Top Leaders Forced Out Over Back-Dated Stock Options. Princessiccia

Princess Health and Cyberonics' Top Leaders Forced Out Over Back-Dated Stock Options. Princessiccia

We had previously posted about the curious way in which Cyberonics' vagus nerve stimulator device was assessed as a treatment for severe depression by a US Food and Drug Administration (FDA) panel. Although a randomized controlled trial failed to show any improvements due to the device that could not be explained by chance alone, after some emotional patient testimonials, the panel voted to approve the device. One panelist later said it was "nuts."

We also posted about questions regarding the authors of an article sponsored by the company about the vagus nerve stimulator. These questions revolved around undisclosed conflicts of interest, and the extent a ghost-author was responsible for the article.

Cyberonics also came to our attention because of questions about stock-options granted to its top executives. Now, according to the Houston Chronicle,
Two top executives have exited Cyberonics, after it disclosed that its stock options problems are much broader than previously reported.

On Monday, investors bid up shares of the Houston-based medical device maker, which said Chairman and CEO Robert Cummins and Chief Financial Officer Pamela Westbrook resigned.

The duo was replaced, on an interim basis, by three people: Tony Coelho as chairman, Reese Terry Jr. as chief executive and John Riccardi as chief financial officer. George Parker was appointed as interim chief operating officer.

The personnel changes came as Cyberonics reported widespread stock option problems in a filing Friday with the U.S. Securities and Exchange Commission.

Before Friday, the company had acknowledged only one instance where stock options were at issue. Those options were given to top executives in June 2004, on the day before the stock market had a chance to react to positive news about a Cyberonics product. Some analysts have described the 2004 options activity as 'make-your-own-luck' grants. Others have called it springloading. On June 9, the SEC began an informal investigation into the two-year-old options.

On Friday, Cyberonics said a board committee that reviewed the company's stock option grants concluded that 'incorrect measurement dates were used for certain stock option grants made principally during the period from 1999 through 2003.'

Cyberonics estimates its financial statements from that period would need to be adjusted to reflect about $10 million in additional 'noncash compensation charges' because of the backdating activity.
It's funny how questionable financial practices seem to go hand-in-hand with dodgy marketing and strange science. In my humble opinion, cases like this suggest the urgent need for better governance of health care organizations, meaning governance that is transparent, accountable, and ethical. But given the way many helath care organizations are currently run, should it be any surprise that costs constantly go up, access constantly goes down, quality is constantly questioned, and health care professionals are increasingly miserable?