------ Forwarded Message > From: "dasg...@aol.com" <dasg...@aol.com> > Date: Sun, 14 Mar 2010 00:27:36 EST > To: Robert Millegan <ramille...@aol.com> > Cc: <ema...@aol.com>, <j...@aol.com>, <christian.r...@gmail.com> > Subject: Meet One of the Two Biggest Beneficiaries of the "Health Care" Bill > > _http://www.waccobb.net/forums/waccoreader/47909-drug-companies-doctors-stor > y-corruption.htm_ > (http://www.waccobb.net/forums/waccoreader/47909-drug-companies-doctors-story- > corruption.htm) > > Drug Companies & Doctors: > A Story of Corruption > > Our system of drug testing is broken. The medical world is compromised by > hidden conflicts of interests and corruption. > > By Marcia Angell > [The New York Review of Books, New York Review of Books -- Vol 56, No 1 ยท > January 15, 2009] > > Recently Senator Charles Grassley, ranking Republican on the Senate Finance > Committee, has been looking into financial ties between the pharmaceutical > industry and the academic physicians who largely determine the market > value of > prescription drugs. He hasn't had to look very hard. > > Take the case of Dr. Joseph L. Biederman, professor of psychiatry at > Harvard > Medical School and chief of pediatric psychopharmacology at Harvard's > Massachusetts General Hospital. Thanks largely to him, children as young > as > two--years-old are now being diagnosed with bipolar disorder and treated > with a > cocktail of powerful drugs, many of which were not approved by the Food > and Drug > Administration (F.D.A.) for that purpose and none of which were approved > for > children below ten years of age. > > Legally, physicians may use drugs that have already been approved for a > particular purpose for any other purpose they choose, but such use should > be > based on good published scientific evidence. That seems not to be the > case here. > Biederman's own studies of the drugs he advocates to treat childhood > bipolar > disorder were, as "The New York Times" summarized the opinions of its > expert > sources, "so small and loosely designed that they were largely > inconclusive."[1] > > In June, Senator Grassley revealed that drug companies, including those > that make > drugs he advocates for childhood bipolar disorder, had paid Biederman $1.6 > million in consulting and speaking fees between 2000 and 2007. Two of his > colleagues received similar amounts. After the revelation, the president > of the > Massachusetts General Hospital and the chairman of its physician > organization > sent a letter to the hospital's physicians expressing not shock over the e > normity > of the conflicts of interest, but sympathy for the beneficiaries: "We know > this > is an incredibly painful time for these doctors and their families, and our > hearts go out to them." > > Or consider Dr. Alan F. Schatzberg, chair of Stanford's psychiatry > department and > president-elect of the American Psychiatric Association. Senator Grassley > found > that Schatzberg controlled more than $6 million worth of stock in Corcept > Therapeutics, a company he cofounded that is testing mifepristone -- the > abortion > drug otherwise known as RU-486 -- as a treatment for psychotic depression. > At > the same time, Schatzberg was the principal investigator on a National > Institute > of Mental Health grant that included research on mifepristone for this use > and he > was co-author of three papers on the subject. In a statement released in > late > June, Stanford professed to see nothing amiss in this arrangement, > although a > month later, the university's counsel announced that it was temporarily > replacing > Schatzberg as principal investigator "to eliminate any misunderstanding." > > Perhaps the most egregious case exposed so far by Senator Grassley is that > of Dr. > Charles B. Nemeroff, chair of Emory University's department of psychiatry > and, > along with Schatzberg, coeditor of the influential Textbook of > Psychopharmacology.[2] Nemeroff was the principal investigator on a > five-year > $3.95 million National Institute of Mental Health grant -- of which $1.35 > million > went to Emory for overhead -- to study several drugs made by > GlaxoSmithKline. To > comply with university and government regulations, he was required to > disclose to > Emory income from GlaxoSmithKline, and Emory was required to report > amounts over > $10,000 per year to the National Institutes of Health, along with > assurances that > the conflict of interest would be managed or eliminated. > > But, according to Senator Grassley, who compared Emory's records with > those from > the company, Nemeroff failed to disclose approximately $500,000 he > received from > GlaxoSmithKline for giving dozens of talks promoting the company's drugs. > In June > 2004, a year into the grant, Emory conducted its own investigation of > Nemeroff's > activities, and found multiple violations of its policies. Nemeroff > responded by > assuring Emory in a memorandum, "In view of the N.I.M.H./Emory/ G.S.K. > grant, I > shall limit my consulting to G.S.K. to under $10,000/year and I have > informed > G.S.K. of this policy." Yet, that same year, he received $171,031 from the > company, while he reported to Emory just $9,999 -- a dollar shy of the > $10,000 > threshold for reporting to the National Institutes of Health. > > Emory benefited from Nemeroff's grants and other activities, and that > raises the > question of whether its lax oversight was influenced by its own conflicts > of > interest. As reported by Gardiner Harris in "The New York Times"[3], > Nemeroff > himself had pointed out his value to Emory in a 2000 letter to the dean of > the > medical school, in which he justified his membership on a dozen corporate > advisory boards by saying: > > Surely you remember that Smith-Kline Beecham Pharmaceuticals donated an > endowed > chair to the department and there is some reasonable likelihood that > Janssen > Pharmaceuticals will do so as well. In addition, Wyeth-Ayerst > Pharmaceuticals > has funded a Research Career Development Award program in the department, > and I > have asked both AstraZeneca Pharmaceuticals and Bristol-Meyers [sic] > Squibb to do > the same. Part of the rationale for their funding our faculty in such a > manner > would be my service on these boards. > > Because these psychiatrists were singled out by Senator Grassley, they > received a > great deal of attention in the press, but similar conflicts of interest > pervade > medicine. (The senator is now turning his attention to cardiologists.) > Indeed, > most doctors take money or gifts from drug companies in one way or > another. M any > are paid consultants, speakers at company-sponsored meetings, > ghost-authors of > papers written by drug companies or their agents[4], and ostensible "rese > archers" > whose contribution often consists merely of putting their patients on a > drug and > transmitting some token information to the company. Still more doctors are > recipients of free meals and other out-and-out gifts. In addition, drug > companies subsidize most meetings of professional organizations and most > of the > continuing medical education needed by doctors to maintain their state > licenses. > > No one knows the total amount provided by drug companies to physicians, > but I > estimate from the annual reports of the top nine U.S. drug companies that > it > comes to tens of billions of dollars a year. By such means, the > pharmaceutical > industry has gained enormous control over how doctors evaluate and use its > own > products. Its extensive ties to physicians, particularly senior faculty at > prestigious medical schools, affect the results of research, the way > medicine is > practiced, and even the definition of what constitutes a disease. > > Consider the clinical trials by which drugs are tested in human > subjects.[5] > Before a new drug can enter the market, its manufacturer must sponsor > clinical > trials to show the Food and Drug Administration that the drug is safe and > effective, usually as compared with a placebo or dummy pill. The results > of all > the trials (there may be many) are submitted to the F.D.A., and if one or > two > trials are positive -- that is, they show effectiveness without serious > risk -- > the drug is usually approved, even if all the other trials are negative. > Drugs > are approved only for a specified use -- for example, to treat lung cancer > -- and > it is illegal for companies to promote them for any other use. > > But physicians may prescribe approved drugs "off label"-- i.e., without > regard to > the specified use -- and perhaps as many as half of all prescriptions are > written > for off-label purposes. After drugs are on the market, companies continue > to > sponsor clinical trials, sometimes to get F.D.A. approval for additional > uses, > sometimes to demonstrate an advantage over competitors, and often just as > an > excuse to get physicians to prescribe such drugs for patients. (Such > trials are > aptly called "seeding" studies.) > > Since drug companies don't have direct access to human subjects, they need > to > outsource their clinical trials to medical schools, where researchers use > patients from teaching hospitals and clinics, or to private research > companies > (C.RO.s), which organize office-based physicians to enroll their patients. > Although C.RO.s are usually faster, sponsors often prefer using medical > schools, > in part because the research is taken more seriously, but mainly because > it gives > them access to highly influential faculty physicians -- referred to by the > industry as "thought-leaders" or "key opinion leaders" (K.O.L.s). These > are the > people who write textbooks and medical journal papers, issue practice > guidelines > (treatment recommendations), sit on F.D.A. and other governmental advisory > panels, head professional societies, and speak at the innumerable meetings > and > dinners that take place every year to teach clinicians about prescription > drugs. > Having K.O.L.s like Dr. Biederman on the payroll is worth every penny > spent. > > A few decades ago, medical schools did not have extensive financial > dealings with > industry, and faculty investigators who carried out industry-sponsored > research > generally did not have other ties to their sponsors. But, schools now > have their > own manifold deals with industry and are hardly in a moral position to > object to > their faculty behaving in the same way. A recent survey found that about > two > thirds of academic medical centers hold equity interest in companies that > sponsor > research within the same institution.[6] A study of medical school > department > chairs found that two thirds received departmental income from drug > companies and > three fifths received personal income.[7] In the 1980s, medical schools > began to > issue guidelines governing faculty conflicts of interest but they are > highly > variable, generally quite permissive, and loosely enforced. > > Because drug companies insist as a condition of providing funding that > they be > intimately involved in all aspects of the research they sponsor, they can > easily > introduce bias in order to make their drugs look better and safer than > they are. > Before the 1980s, they generally gave faculty investigators total > responsibility > for the conduct of the work, but now company employees or their agents > often > design the studies, perform the analysis, write the papers, and decide > whether > and in what form to publish the results. Sometimes, the medical faculty > who > serve as investigators are little more than hired hands, supplying > patients and > collecting data according to instructions from the company. > > In view of this control and the conflicts of interest that permeate the > enterprise, it is not surprising that industry-sponsored trials published > in > medical journals consistently favor sponsors' drugs -- largely because > negative > results are not published, positive results are repeatedly published in > slightly > different forms, and a positive spin is put on even negative results. A > review > of seventy-four clinical trials of antidepressants, for example, found > that 37 of > 38 positive studies were published.[8] But, of the 36 negative studies, > 33 were > either not published or published in a form that conveyed a positive > outcome. It > is not unusual for a published paper to shift the focus from the drug's > intended > effect to a secondary effect that seems more favorable. > > The suppression of unfavorable research is the subject of Alison Bass's > engrossing book, "Side Effects: A Prosecutor, a Whistleblower, and a > Bestselling > Antidepressant on Trial." This is the story of how the British drug giant > Glaxo-SmithKline buried evidence that its top-selling antidepressant, > Paxil, was > ineffective and possibly harmful to children and adolescents. Bass, > formerly a > reporter for the Boston Globe, describes the involvement of three people > -- a > skeptical academic psychiatrist, a morally outraged assistant > administrator in > Brown University's department of psychiatry (whose chairman received in > 1998 over > $500,000 in consulting fees from drug companies, including > GlaxoSmithKline), and > an indefatigable New York assistant attorney general. They took on > GlaxoSmithKline and part of the psychiatry establishment and eventually > prevailed > against the odds. > > The book follows the individual struggles of these three people over many > years, > culminating with GlaxoSmithKline finally agreeing in 2004 to settle > charges of > consumer fraud for $2.5 million (a tiny fraction of the more than $2.7 > billion in > yearly Paxil sales about that time). It also promised to release > summaries of > all clinical trials completed after December 27, 2000. Of much greater > significance was the attention called to the deliberate, systematic > practice of > suppressing unfavorable research results, which would never have been > revealed > without the legal discovery process. Previously undisclosed, one of > GlaxoSmithKline's internal documents said, "It would be commercially > unacceptable > to include a statement that efficacy had not been demonstrated, as this > would > undermine the profile of paroxetine [Paxil]."[9] > > Many drugs that are assumed to be effective are probably little better than > placebos, but there is no way to know because negative results are hidden. > One > clue was provided six years ago by four researchers who, using the Freedom > of > Information Act, obtained
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