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    Saturday, June 6, 2009

    The War Of The “Pharmascolds.”

    And What Has This To Do With Professors As Impartial Medical Expert Witnesses?

    "Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one." - Charles Mackay
    Henry Kissinger once said that the reason why fights between academics are so vicious is because the stakes are so low.
    But not so in this era. The stakes are pretty high -- in the billions of dollars.

    Eric G. Campbell points out in “The Future of Research Funding in Academic Medicine” in the NEJM [April,2009] that” medical schools and teaching hospitals in the United States are essential producers of basic scientific and clinical knowledge that drives our supply of new medicines, devices, and other health care innovations. His points:

    • The federal government is the single largest source of financial support for academic life-sciences research in the United States. At the 20 most research-intensive medical schools, an average of 80 to 85% of total research revenues, and about one third of all revenues, come from federal research grants. From 1971 through 2003, the average annual increase in the budget of the National Institutes of Health (NIH) was 9%, or 3.4% with adjustment for inflation. However, in the past 5 years there has been no appreciable growth in this budget — indeed, given the rate of inflation, there was a 13% decrease.

    • The second major source of support is industry — makers of medical devices, pharmaceuticals, and biotechnology products, which primarily fund clinical trials and other late-stage clinical research. Although it is difficult to determine the amounts of and trends in industry funding specifically targeted for academic research in the life sciences, the National Science Foundation estimates that the industry's share of support for academic research and development in all fields peaked at 7% in 1999 and decreased to its current level of 5% in 2003. Evidence of this decline can be found in a national survey of medical school researchers conducted in 2008. This has been associated with the growth of contract research organizations and increased focus on international research and the generic drug market.”

    • “The future of industry support is uncertain,” says Campbell,” but current trends suggest there will be further decreases.

    • Industry-sponsored clinical trials are rapidly moving to poorer countries.

    • Reductions in industry funding could make it increasingly difficult for U.S. academic health centers to maintain their clinical and translational research enterprises — and may hit the most productive and senior faculty members hardest, since they are the most reliant on such support.

    While medical research funds are decreasing medical schools across the U.S. have come under fire for not fully disclosing financial ties between researchers, pharmaceutical and medical-device companies. In October, 2009 Senators Charles Grassley, a Republican from Iowa, and Herb Kohl, a Democrat from Wisconsin inquired about links between 22 university professors and device companies. That shot from Washington started an en masse rush towards the exits.

    In a hurried response medical schools across the country like Johns Hopkins University’s medical school say [NYT 4/8/09] that they will restrict interactions between doctors and industry representatives. Stanford University School of Medicine, said ON April 1, 2009 that it will require doctors to post industry income and royalty payments on a school Web site. Harvard Medical School also promised that it will review its policies on conflicts of interest in drug research. Columbia University is doing the same thing.

    “The outrage comes easily for Grassley — but there are some gray areas” say observers. Medical-school professors get their jobs in the first place because they know their fields. Forbid such educated people to consult with the companies that develop new medicines and you cut off a valuable source of knowledge. What's more, pharma's largesse also flows to the schools themselves in the form of multimillion-dollar endowments. Whether or not the companies are trying to curry favor, they're also building labs and bankrolling scholarships — something that becomes increasingly important as the deteriorating 2009 economy causes philanthropic giving to dry up. No one disagrees that isolating academia from the industry may be ideal, but even many academics concede that the cooperation yields more good than harm.

    Though admitting that “working with industry is essential to fulfilling our academic mission, “we have to do it in a way that removes potential bias and preserves the public trust in our institutions,” said Eugene Braunwald, a noted cardiologist. In other words we don’t like the bad publicity. "We don't want our faculty being on the road" as "hired guns," chimed in Dr. Peter Slavin, president of the prestigious Mass. General Hospital who joined the herd rushing to the exits. Slavin maintains that he wants to prohibit physicians from eating meals on a company's tab, including lunches bought for doctors-in-training in the hospital, because it "doesn't promote a positive image of physicians and increases healthcare costs." How does it increase healthcare costs—he doesn’t say.

    These new university policies also prohibit gifts like pads, pens and pencils, entertainment or food to underlings like house-staff or even attending physicians— regardless of low value — from drug and medical device companies.

    Talk about using a crisis to get what you want — here’s the kicker—donations [if any] from industry will have to be given to the Medical schools themselves rather than individual doctors. This puts the dollars right where the deans and university presidents have always wanted it.

    Although Campbell above has shown that industry dollars are dwindling a harsh critic of industry medical school partnerships — Dr. Arnold Relman, a Harvard Medical School professor and former editor of the New England Journal of Medicine, complains that the medical education provisions don't go far enough. "There should be no, zero, industry funding for any particular educational program," he says. "If you know your . . . program is dependent on money from a company, it's impossible not to be influenced by that fact."

    Critics on the opposite side of the fence like Dr. Thomas Stossel, say restrictions on the interactions between doctors and industry could ultimately hurt patient care. "We have all these tools now for caring for patients, and those tools have come from physicians working with industry." Dr. Stossel, professor of medicine at Harvard, was joined by David A. Shaywitz, a management consultant to add [4/9/09, NYT] that this situation is "largely because of the disproportionate influence of a coterie of prominent critics we have previously dubbed 'pharmascolds’. They routinely vilify the medical products industry and portray academics working with it as traitors and sellouts."

    “Given the vital role of medical products companies and the magnitude of their challenges, one might imagine that this industry would be admired,” they say. “These critics are pious academics, self-righteous medical journal editors, and opportunistic politicians and journalists. Their condemnation of anyone's legitimate profit — it's all "corruption" in their book -- has in fact materially enhanced their own careers. They extrapolate from occasional behavioral lapses in industry -- which is equally, if not more prevalent, in universities — to demonize the market and portray scientific medicine as an ascetic religion, which it is not.”

    Are the problems of the full time salaried academic medical expert who should be impartial in court not solved by these “reforms?”
    Not according to Dr. Arnold Relman who complains above that the medical education provisions don't go far enough and that there should be no, zero, industry funding for any particular educational program," ..because "If you know your . . . program is dependent on money from a company, it's impossible not to be influenced by that fact." In other words it’s hard for an academician receiving money even indirectly from drug companies to not be biased. It is difficult for a medical expert witness who draws his salary from a medical school and now indirectly from a drug company to be fair about anything involving the company’s drugs —especially if the case involves a patient receiving one of these drugs

    That’s it in a nutshell. How is bias removed from a medical expert whose fulltime salary is paid by a fund granted by industry? Does not the expert know which drug company[s] are paying his weekly salary? Does he not know which drugs are being worked on by his medical school —and his colleagues? And does he not know that money coming in to pay his salary depends on the medical school’s relationship with the drug company?

    The opposing attorney knows full well that you cannot leap a chasm in two jumps. Removing food and do-dads from medical student lunch boxes and replacing the saved money into the deans coffers offers no consolation to the academic medical expert if his salary is now being paid by the drug company. In fact, where there were only a few academic full timers on a drug company payroll there are now hundreds more who are on the entire medical school full time faculty payroll — feeding from the same trough.

    Live interview Monday, June 8th 11AM, ET with Sybil Tonkonogy on WNTN (AM 1550), Newton, MA. Interview will also air live on radio's web site, http://www.wntn.com



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