¿Cual es el gold standard? ¿Quien lo formula?

La efectiva comprobación del vínculo íntimo entre investigadores de un supuesto “primer nivel”, con muchos papers en Journals de “alto impacto”, y la industria farmacéutica nos obliga a varias reflexiones, algunas de ellas algo incómodas. Por ejemplo, desde Latinoamérica insistimos (creo que con amplia razón), en el que grupo control de un ensayo clínico reciba el mejor tratamiento existente (no el disponible localmente). Pero, si el mejor tratamiento existente está determinado por Task Groups internacionales (léase en general USA, UK, y poco más), y el 90% de sus integrantes está financiado por la industria; y si el financiamiento de la industria produce opiniones sesgadas: ¿que usamos? Otro tema vinculado: si nuestras universidades y sistemas de investigación nos evalúan a través del impacto de nuestros papers, pero los journals importantes están vinculados a la industria, en realidad ¿quien nos evalúa?.

Creo que hasta que no comencemos a desarrollar un sistema regional propio de investigación, en el que los standards los fijemos nosotros, así como las prioridades de investigación en salud deriven de las reales necesidades de nuestros pueblos y no de las necesidades de mercados y académicos de los países que nos colonizan, estaremos a merced de estos autores y de estas revistas internacionales. Hay esfuerzo regionales en marcha. Si algún lector tiene más información sería muy interesante que nos la envíe. 

Los invito a opinar, mientras tanto algún material al respecto, donde revistas muy importantes están en discusión (JAMA, NEJM, Lancet, BMJ, etc…)

LJ

Harvard / Stanford–Psychiatry’s Opinion Leaders Financial Ties to Industry

Wednesday, 12 July 2006

Two probing first rate investigative reports document how psychiatry’s treatments are shaped by “opinion leaders” whose professional recommendations are compromised by their substantial, largely undisclosed, financial ties to drug companies.

 Whether their faculty positions are at Harvard or Stanford, one cannot discern a modicum of science to back up their treatment recommendations.
1. David Armstrong of the Wall Street Journal documents violations of medicine’s foremost ethical principle, “first, do no harm,” by influential academic psychiatrists who promote psychotropic drugs for pregnant women that will cause harm to their developing infants.   Specifically, thirteen leading industry-financed psychiatrists from Harvard, UCLA and Emory, published a report in JAMA (2006) whose aggressive promotion in the local and national media was designed to frighten pregnant women and to dissuade them from stopping antidepressants during pregnancy. [1]
The authors emphasized a (previously unreported) risk of relapse, disregarding a body of evidence (documented since 1993) demonstrating that exposure to serotonin (SSRI antidepressants) in utero has caused birth defects, cardiac malformation, respiratory distress, and severe withdrawal syndrome in infants. The authors even disregarded manufacturers’ disclosure on SSRI-SSNRI drug labels which acknowledge that the drugs pose risks of harm to neonates who “have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.” (June 2004) http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#effexor
http://www.ahrp.org/infomail/04/06/29.php
Indeed, documented evidence of drug-induced harm in infants is mounting—most likely reflecting the widespread misuse of these drugs by pregnant women.  A study of 1,213 women by Dr. Christina Chambers, published in the NEJM (2006) warned about an alarming six-fold increase in a dangerous respiratory condition–persistent pulmonary hypertension (PPHN)–among babies born to mothers who used SSRI’s late in their pregnancy. PPHN is a condition marked by severe respiratory failure, normally occurring in about one or two infants per 1,000 births. However, for babies exposed to antidepressants late in pregnancy, the rate rose to six to 12 births per 1,000. And of babies born with the condition 10% to 20% do not survive. Demonstrating their disdain for scientific evidence, Industry-paid psychiatrists at Harvard disparage Dr. Chambers’ study, arguing its findings didn’t “jibe” with their experience.
Psychiatrists who recommend antidepressants for pregnant women may be more intent on reversing declining SSRI sales than protecting infants. SSRI sales have plummeted since 2004. The percentage change between 2004 and 2005: Zoloft ($3.1 billion) down 2%; Paroxetine (generic, $0.5 billion) down 27%; Paxil (GSK, $0.3 billion) down 61%; Prozac ($0.2 billion) down 7%. Lexapro alone showed increased sales: ($2.1 billion) up 19%.  
The WSJ reveals that the lead author of the JAMA report—Dr. Lee S. Cohen, a Harvard Medical School professor and director of the perinatal and reproductive psychiatry research program at  Massachusetts General Hospital – “is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers. None of his financial ties were reported in the study. In total, the authors failed to disclose more than 60 different financial relationships with drug companies.”
JAMA’s failure to enforce its conflict of interest disclosure policy raises serious questions about the journal’s role as a promoter of industry’s marketing agenda rather than a gatekeeper protecting the integrity of scientific and ethical standards in research.

Dr. Cohen and his co-authors would have us believe that they are not of the same human species as the rest of us when claiming “their financial links have no bearing on their research work or what they say about antidepressant use during pregnancy in interviews or lectures.”  However, “he declined to specify what he does in his consulting role for the companies or how much he is paid, other than to say “we are not talking about megabucks.” Dr. Cohen said “it didn’t seem relevant” for him and several of his co-authors to disclose their industry relationships in the JAMA paper in part because the study was funded by the government, not drug makers.
The WSJ reveals that Harvard Medical School Symposia for doctors, billed as “CME–continuing medical education–you can trust,” are rigged as they are almost exclusively comprised of psychiatrists with financial ties to drug makers who promote the expansive use of psychotropic drugs. Indeed, the Mass General psychiatry academy “itself is funded by six drug makers, including two antidepressant makers.”  
“The work of these academic researchers highlights the role of “opinion” or “thought” leaders coveted by drug companies because of their ability to influence not only the practice of doctors, but popular opinion as well. In the case of antidepressant use during pregnancies, the industry-paid opinion leaders have become dominant authorities in the field. They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors. In some cases, the financial ties between industry and these leading researchers are not disclosed.” See: http://online.wsj.com/article/SB115257995935002947.html
2. The second report in a series by Paul Jacobs of the Mercury News (California Bay area) documenting conflicts of interest at Stanford University focuses on the substantial financial interests of its chairman of psychiatry, Dr. Alan Schatzberg who “announced with considerable fanfare” that he may have found a better way to treat depression in “a repackaged version of RU-486, the controversial abortion pill,” which he claimed, “may be the equivalent of shock treatments in a pill” without the side effects.”
Mercury News notes, “Schatzberg has more than a purely scientific interest in this particular pill. He has a financial conflict of interest.” Dr. Schatzberg “administers a $600,000-a-year federal grant, part of which pays for ongoing research at the medical school on mifepristone, the key ingredient in RU-486, in depression. He is also co-founder of Corcept Therapeutics in Menlo Park, a publicly traded company that hopes to turn mifepristone into an approved treatment for depression and other psychiatric ills. He sits on the company’s board of directors, chairs its scientific advisory board and is one of its largest shareholders. And because the company has an exclusive license from Stanford for Schatzberg’s discovery, the university also stands to profit from Corcept’s work.
“The stakes for Schatzberg, his company, the university and severely depressed patients are huge. Corcept estimates that 3 million patients could benefit from the drug. Schatzberg, whose family has paper profits of nearly $12 million from Corcept stock, could reap millions more if the company’s treatment is approved.” Dr. Schatzberg’s extensive financial ties to pharmaceutical companies are listed at: http://www.mercurynews.com/mld/mercurynews/living/education/15004544.htm?
“Such conflicts are surprisingly common in the high-stakes world of academic medical research. But what makes Schatzberg’s case unusual is that two other top research psychiatrists have publicly attacked his work and accused him of shoddy science. Schatzberg’s conflict is a lesson in how hard it can be for a leading scientist at a major medical school to disentangle his outside financial interests from his academic role.”
An unusual development (in psychiatry) is that Dr. Schatzberg’s published and public claims were challenged by two prominent psychiatrists. Mercury News outlines the details of a poster critique by Drs. Bernard J. Carroll and Robert T. Rubin who “systematically picked apart the conclusions in three published studies of RU-486 in depression, two by Schatzberg and his colleagues, one by an independent group….The poster, presented at the annual meeting of the ACNP juxtaposed positive public statements about the drug by Schatzberg and other researchers and juxtaposed those statements against the individual’s financial interest in Corcept.  
There, for example, was Schatzberg saying RU-486 may be “the equivalent of shock treatments in a pill” and a statement pointing out that he owned 3 million shares of Corcept stock. The point was hard to miss: Researchers with a financial interest were expressing “considerable enthusiasm” for a treatment of questionable effectiveness.   
See: http://www.mercurynews.com/multimedia/mercurynews/archive/posteranddebate.pdf

Reference:

1. Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment.  JAMA. 2006 Feb 1;295(5):499-507.

Ver en: http://www.ahrp.org/cms/content/view/286/55/

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