November 29

Contracts Keep Drug Research Findings Concealed – NY Times

Contracts Keep Drug Research Findings Concealed – NY Times

Mon, 29 Nov 2004

I. A front page article in the New York Times focuses on academia’s role (culpability) in keeping mum about the unpublished antidepressant clinical trial results.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 researcher 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 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 Texast in Dallas, the leading investigator in numerous pediatric antidepressant drug trials. When asked if he knew about the data recdently 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 finaced 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

November 29, 2004, Front Page
Drug Testing Doesn’t Always Tell the Whole Story

Last December, medical school researchers came to a professional meeting in PuertoRico with a sense of urgency. Federal drug regulators were reviewing unpublished data from their studies on the use of antidepressants in children and adolescents to see if the drugs increased suicide risks.

The group included many of the researchers whose published positive findings had helped persuade doctors to prescribe antidepressants like Paxil, Zoloft and Prozac to young patients. Now, faced with growing safety questions, the researchers had been trying for months to gather all the test data about those and similar drugs to see if they had missed a pattern not apparent in any single trial.

But they could get only pieces of that information.

Some drug companies refused to turn over data to the group, even though these researchers had helped come up with it, the researchers recalled. In other cases, they could not freely share their own data with colleagues who had not worked on a test. The reason, they said, was that medical schools, in agreeing to run the tests, had signed agreements with the drug makers that kept the data confidential.

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.

The upshot is that doctors may not get all the information they need. In the wake of revelations about unpublished test data showing the potential risks of pediatric antidepressants, some doctors have stopped prescribing them. And even doctors who continue to prescribe the drugs question why they were kept in the dark.

“I think it would have been more helpful for everyone to have known what was going on at the time that it was happening,” Dr. Robert Feder, a psychiatrist in Manchester, N.H., said.

In recent months, the outrage over the withheld antidepressant data has led calls for change and promises of some. Drug companies, faced with widespread criticism about their handling of test information, have promised to release more of it. Legislation has been introduced in Congress that would require all makers of drugs and medical devices to list clinical trials and their results in a public database.

Critics say, however, that academic institutions and their researchers need to examine their own practices because they share part of the blame.

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