FDA Strong Drug Ties-Less Monitoring – UK MHRA

Mon, 6 Dec 2004

A front page article in The New York Times provides a historical perspective to the shift in FDA’s focus (in 1992) from watchdog safeguarding the public against hazardous drugs, food and medical devices, to its current role as industry’s marketing facilitator.

Dr. David Graham’s assertion that the culture of the agency renders it incapable of protecting the public against another lethal drug, such as Vioxx, is validated by drug safety experts in and out of government.

Indeed, outgoing Secretary of Health and Human Services, Tommy Thompson, acknowledged that he favors creating an independent drug safety monitoring center. Even FDA’s deputy commissioner, Dr. Janet Woodcock, acknowledges that FDA’s current safety monitoring system “is not good for determining if a drug increases the rate of a side effect already common in the population” – e.g., heart attacks.

Furthermore, the Times reports, Dr. Woodcock acknowledged in a March 2000 letter to Senator Jim Jeffords, that “more than 1.6 million people in the United States were hospitalized every year because of drug side effects. Half of these problems are preventable.”

See: GARDINER HARRIS At F.D.A., Strong Drug Ties and Less Monitoring, THE NEW YORK TIMES December 6, 2004

The Associated Press cites FDA’s acting commissioner who declared: “Medicines that receive FDA approval are among the safest in the world.”

Similarly, a statement by Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America: “In the vast majority of cases, these medications are doing what they are supposed to do.”

These classic expressions of denial underscore the cultural collision that has led to a public policy crisis. Critical safety issues affecting the lives of the people collide with the single minded marketing goals of the pharmaceutical industry–profits at any cost including mounting, preventable human casualties.

See: Medical officials question drug safety in U.S. Associated Press, December 5, 2004

Across the Atlantic, officials of the Medicines and Healthcare Products Regulatory Authority (MHRA, FDA’s equivalent) are about to make fools of themselves by issuing a clean bill of health to SSRI antidepressants. MHRA officials acknowledge that they have not actually examined the clinical trial data, but are relying on summaries selected and submitted by drug manufacturers. Given the documented revelations demonstrating a pattern of deceit by drug manufacturers, it is difficult to fathom what these UK regulators expect to accomplish–other than garnering public contempt.

Contact: Vera Hassner Sharav
212-595-8974

http://www.guardian.co.uk/medicine/story/0,11381,1367185,00.html
Antidepressants to be ruled safe
Watchdog criticised for today’s announcement
Sarah Boseley, health editor
Monday December 6, 2004
The Guardian

The government’s medicines watchdog is expected to rule today that most of the controversial modern antidepressant drugs, such as Prozac and Seroxat, are safe for adults, despite psychiatrists and users expressing extreme concern that it has not seen the full data on side-effects.

The Medicines and Healthcare Products Regulatory Authority (MHRA) appointed an expert working group two years ago to investigate the drugs’ safety, after it was claimed that they could make people feel aggressive and suicidal, and that some users experienced distressing symptoms if they tried to come off them.

Last December the MHRA banned all but one drug, Prozac, from being prescribed to children under 18, after all the clinical trial data, which extended further than the papers published by the drug companies, had been scrutinised.

The new data showed that the drugs did cause some children to feel hostile and suicidal, and that they were no better at alleviating childhood depression than a placebo – a dummy pill.

Today’s MHRA announcement will clear most of the drugs known as SSRIs (selective serotonin reuptake inhibitors) for use by adults, with the probable exception of venlafaxine, which is already recognised as having problematic side-effects.

But senior psychiatrists and the user group involved in the review are deeply troubled that the MHRA has made its decision without seeing raw data from the unpublished trials.

The MHRA has confirmed to the Guardian that most of the data supplied to it has been in the form of drug companies’ summaries, plus “some individual case reports”.

When what should be the final verdict on the drugs is announced today there will be no representatives there from the Royal College of Psychiatrists and the mental health charity Mind, whose chief executive, Richard Brook, resigned from the MHRA in March, accusing it of sitting on evidence that Seroxat had been prescribed in unsafe doses for 10 years.

GlaxoSmithKline has posted the results of its Seroxat trials on children on its website, in response to criticism about the lack of publication.

But David Healy, professor of psychiatry and director of the North Wales department of psychological medicine, said even that information was incomplete.

Company summaries of trial results were not adequate, he argued. “In the case of just one drug, sertraline [brand name Lustral], I have seen at least three different summaries of the data during a two year period, covering the same set of trials”, he said.

GlaxoSmithKline is being investigated for an alleged failure to disclose information about risks to children it would have known about for several years before it told the MHRA.

It is thought that the unpublished trials of all the SSRIs on adults outnumber published results by eight to one.

Mr Brook said: “It’s amazing that the inquiry was set up two years ago and the MHRA has still not seen the original data. This surely raises questions about their ability to get to the heart of the matter.”

The MHRA says it would not have been possible to study all the original data, because of the sheer amount.

“We would be looking at years,” a spokeswoman said. “It is just not feasible.”

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