How Big Pharma Gets All Those Favorable Reports On Drugs.... by Lapis .....

Here is a release from the watchdog group, the Alliance for Human Research Protection. It spells out one method whereby research fraud infects the whole process of drug approval and paints a false picture of what's really going in the lab.

Date:   6/12/2005 7:16:38 PM ( 18 y ago)



NOVEMBER 29, 2004.

The release also points a finger at the now-notorious Texas child- drugging program that is the model on which Bush's national screening (for mental disorders) plan is based.

The corporate (drug-company) invocation of "it's proprietary information" is mentioned. This is the cover behind which drug companies can pay for drug studies and then suppress the results, if they don't like the outcomes.

Promoting Openness and Full Disclosure


I. A front page article in the New York Times focuses on academia’s role (culpability) in keeping mum about the unpublished antidepressant clinical trial results. The unnamed focus of the article is the industry-supported American College of Neuropsychopharmacology (ACNP) whose members—leading academic psychiatrists—have been caught aiding and abetting industry’s concealment of negative test findings. One of the major players in the pediatric antidepressant debacle is University of Texas child psychiatrist, Dr. Karen Wagner (who refused to be interviewed by the Times).

The Times reports: “Over the last decade, Dr. Wagner has led or worked on some 20 studies published in medical journals, and the government has financed her work. She has attracted a large number of industry-financed studies.”

“In her Zoloft study, Dr. Wagner acknowledged that she had received 'research support' over the years from several drug manufacturers including Pfizer, which paid $80,000 to the Galveston center in connection with the Zoloft test. But she did not state that she also received sizable payments from the company for work she did related to the test.”

Barry Meier shines a light on the financial stake that these academic researchers and medical centers have in suppressing scientific negative findings that contradict the claims made about the safety and effectiveness of antidepressants. Major academic medical centers and researchers freely signed corporate contracts prohibiting researchers from publishing their findings until their corporate sponsors give the O.K.

Those institutions willingly signed contractual agreements with drug manufacturers agreeing to prohibit medical scientists from carrying out their professional and moral responsibility toward their human subjects, the medical community, and public—whose taxes pay most of their salaries.

“Academic institutions and researchers are widely viewed as the impartial, independent heart of the system this country uses to test drugs and medical devices. But that independence often comes with strings attached, sometimes making academic institutions and their researchers obstacles to the exchange and discussion of test results.”

“All the pediatric antidepressant studies were run in part [sic] at medical schools, and in many cases the tests were led by academic scientists. But while one study of the drug Paxil, which showed positive results in depressed children, was published, another study showing that it was ineffective was not submitted to a medical journal. Studies of the other antidepressants like the drugs Remeron and Serzone were also not published. However, there are few, if any, indications that the academic researchers involved in those trials pushed for their publication or widespread distribution.”

In their pact with industry, academic institutions have made a mockery of “academic freedom”: they have become active participants in research fraud and deception.

“Drug companies say that because they pay for the trial they own the data it generates.”

Really? Would a realtor who paid for the construction of a building get away with concealing evidence that the building is unsafe for habitation ?

II. A year long series of investigative reports by Nancy Wilson, Keye News (Texas CBS-affiliate) has uncovered who the beneficiaries are of a hugely profitable market that has led to abusive prescribing of psychotropic drugs for children. On Nov 24, the focus was on Dr. Graham Emslie of the Unviersity of Texas in Dallas, the leading investigator in numerous pediatric antidepressant drug trials. When asked if he knew about the data recently analyzed by the FDA showing the drugs to have serious adverse side effects and that the drugs were no more effective than a sugar pill, Dr. Emslie admitted: “I already knew the data…but because of proprietary …” he didn’t tell.


Dr. Emslie and Dr. Wagner were hired by the state of Texas to make recommendations to the state mental health department for the treatment of depressed children. They recommended using the very drugs they knew to have serious risks without a demonstrable benefit greater than a sugar pill for children—as first line treatment in state funded facilities.

Both Dr. Emslie and Dr. Wagner served on the Texas Medication Algorithm Project (TMAP) panel whose treatment recommendations are not borne out by the scientific evidence.

TMAP was financed by the manufacturers of psychotropic drugs—in states that have adopted TMAP as their guideline, its list of recommended drugs is mandated by state mental health agencies. TMAP recommendations are not based on scientific evidence—but rather the consensus of the panel who was financed by psychotropic drug manufacturers.

The national media has yet to pick up the national trail that begins in Texas.

Contact: Vera Hassner Sharav 212-595-8974



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