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Friday, July 21, 2006

It's not Just Stem Cells

(Keywords and tags: , , , 's is more concerned with and the than your )

Bush's veto of legislation to expand federally funded embryonic stem cell research has gotten a lot of headlines. "I felt like crossing this line would be a mistake, and once crossed we would find it almost impossible to turn back," he said,"Crossing the line would needlessly encourage a conflict between science and ethics that can only do damage to both, and to our nation as a whole."

I know, now he's all concerned about ethics - when it's about potentially lifesaving treatments, questionable ethical concerns are foremost. When it's about illegal wiretapping, outing a CIA agent, or lying your way into to war - ethics ain't so much of a concern.

And you can't really say that the administration is putting medical ethics into a separate category, above other ethical concerns. The Union of Concerned Scientists reports that nearly one fifth of scientists at the Food and Drug Administration said they "have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."

"Science must be the driving force for decisions made at the FDA. These disturbing survey results make it clear that inappropriate interference is putting people in harm's way," said Dr. Francesca Grifo, Senior Scientist and Director of UCS's Scientific Integrity Program. "FDA leaders should act now to improve transparency and accountability and renew respect for independent science at the agency."

The UCS survey, which was co-sponsored by Public Employees for Environmental Responsibility, was sent to 5,918 FDA scientists. Forty percent of respondents fear retaliation for voicing safety concerns in public. This fear, scientists say, combines with other pressures to compromise the agency's ability to protect public health and safety. More than a third of the respondents did not feel they could express safety concerns even inside the agency.

"This is more than just a bureaucratic problem within the agency," said Kim Witczak,, who lost her husband due to side effects of a dangerous anti-depressant [Zoloft].

The survey found:

  • 61 percent of the respondents knew of cases where "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."
  • Only 47 percent think the "FDA routinely provides complete and accurate information to the public."
  • 81 percent agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."
  • 70 percent disagree with the statement that FDA has sufficient resources to perform effectively its mission of "protecting public health…and helping to get accurate science-based information they need to use medicines and foods to improve their health."

To return to Kim Witczak, widowed by Zoloft; her husband suffered from a side effected that caused akathisia, a condition in which the patient finds it impossible to be comfortable in their own skin. This cost her husband his life by making him suicidal.

In a past wrongful death lawsuit against Pfizer, one of Pfizer’s own expert witnesses, Dr. John Mann, testified that "akathisia has the potential, when it is severe, of contributing to suicidality and aggression." Another drug company expert testified: "I believe that what akathisia does is it creates a state of severe anxiety which can exacerbate pre-existing proclivities, tendencies, in an individual to engage in either suicide or violence."

To top it off, we personally heard the FDA’s Dr. Robert Temple state, “There isn’t any doubt that these drug cause akathisia. That’s not in doubt.”

Why then, when the FDA and drug companies have known that these drugs can cause akathisia and for some people suffering from akathisia find “death a welcome result“ to escape its symptoms, haven’t they warned the doctors, patients, parents and the public about this potentially deadly side effect?

We learned that these types of warnings already exist in other countries for the same drugs. However, they are just marketed under different names than in the United States. In fact, the BBC did an interesting documentary on the effects of 'Seroxat' and other SSRI drugs and warned of the serious, sometimes deadly side effects. Seroxat is known in the US as Paxil. Lustral is the same thing as Zoloft manufactured by Pfizer. Watch the BBC documentary

Marketing concerns aren't the only driving force behind the suppression of sound science. Ideology also plays a part - as it has with embryonic stem cell research. In 2005, the FDA refused to allow over the counter sales of Plan B or 'the morning-after pill'. The reasoning was, according to the Washington Post, "there was not enough information on how easy access would affect the sexual behavior of young teenagers."

Not surprisingly, this was untrue. WaPo reported, "'Our findings were that women don't change their sexual behavior when the drug is easily available, but rather that they're more likely to use it if access is easier,' said lead author Tina R. Raine of the Center for Reproductive Health Research and Policy at the University of California at San Francisco."

Of course, it wasn't concerns about behavior at all that kept Plan B off the shelves. According to columnist Ellen Goodman:

Putting Plan B on the drugstore shelf would mean that women who had unprotected sex or contraceptive failures could easily and quickly prevent pregnancy.

But under pressure from the prolife fringe that insists against all evidence that emergency contraception is abortion in disguise, the FDA caved. Executing a fandango that Karl Rove would admire, the FDA first boxed the manufacturer into seeking permission for over-the-counter sales only to those 17 or over. Then it rejected the adults-only plan on the grounds that the pills could still fall into the hands of younger teens.

Once again, real science and sound research were thrown aside in favor of the GOP's lunatic, neanderthal base.

Your health is no longer the FDA's concern. It serves the pharmaceutical industry and the christian right.