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Letters
Thursday, December 7, 2006 12:00 AM

Glaxo's guinea pigs

The pharma giant is accused of putting pregnant women at risk in unethical drug trials.

The letters thread is now closed.

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Thursday, December 7, 2006 08:13 AM

Not sure I get the logic

Glaxo didn't put these women in *more* danger than they already were, they just didn't put them in *less* danger. The women given the placebo were no worse off than they would have been had they not been involved with the drug trial at all. You have to have a control group for *any* experiment like this, right? If you know you're involved in a drug trial, you know you might be getting a placebo. That's just the way things are.

Thursday, December 7, 2006 08:17 AM

Why don't they ever define "defects?"

Why is it that whenever I read an article (such as this one) that mentions "birth defects" as a result of some drug or other factor, it never specifies what KIND of defects? Are we talking about a relatively mild condition that can easily be remedied by modern medicine, or a truly life-altering tragedy? In other words, what kind of cost-benefit analysis is being applied in terms of danger to the mother if she DOESN'T take the substance, vs. potential and degree of danger to the baby if she DOES?

Thursday, December 7, 2006 08:17 AM

Clinical Tests

I have no love of Big Pharma, but before we condemn on the basis admistering placebos, I think a little more research is warranted on these studies. Just because one study proves that a drug effective in one circumstance means that it's effective in all circumstances - that's why we they have different clinical trials with different patients. Don't condemn companies for testing when we condemn them for not testing. You can't have it both ways.

Thursday, December 7, 2006 08:29 AM

Carol Lloyd

Just because you call it a blog doesn't mean you get to run without facts. This column, like most of your work, runs the gamut of logical fallacies and is philosophically no different than listening to Limbaugh or Hannity. You take a factoid and spin it every way possible to benefit your pre-determined snarky point of view. Incidentally, you writing does nothing to convince me Hitchens was wrong, at least about you. You're not funny, nor clever, or even readable.

Thursday, December 7, 2006 08:30 AM

AZT Nonsense

Just so you'll know, AZT has been shown to cause spontaneous abortion in pregnant women, among other grisly results, so the placebo group may actually do better than the drug-taking group. That Glaxo would actually conduct such a study is puzzling, however; since the mid-'90s non-placebo studies have been allowed on pregnant women in Third World countries. This, by the way, apparently violates the Nuremberg Code's prohibition of studies conducted without "informed consent," because none of these subjects would have been informed of the risks of AZT or the uncertainties of current knowledge on HIV, including whether its presence actually leads to illness in newborns.

If the company is indeed carrying out these trials with placebo controls, and finishes them, they would be the first. The original studies leading to the 1987 approval of AZT for use in the U.S. became unblinded and quickly abandoned the placebo controls. The warning label on AZT, which I assume none of the pregnant women in Africa are presumably going to see, has a skull and crossbones on it -- meaning, this stuff is highly toxic. It's still being tested on patients out here in the real world because it was not adequately tested before approval. Nonetheless, it is illegal for mothers in the U.S. to refuse treatment by this drug and other HIV "antivirals" (a misnomer, because there is no proof that they actually kill any live virus; they kill cells). Many women have left the country to avoid this mandatory care.

So now you know.

Undoubtedly, the women in the control group in this African study you mention will do better than the women in the drug-taking group. When this happens, the study will be suppressed, never published, and phone calls seeking information about it -- assuming anyone knows about it -- will not be returned. This is standard practice in AIDS research, and suppression of unfavorable studies is allowed under FDA rules.

See Harper's, March 2006, "Out of Control," for further information on Nevirapine trials in Uganda. Pretty close to nobody got out of these alive or untouched by serious "side effects," but the drug went on to more studies, and more deaths, in the U.S.

Newer drugs -- after AZT -- cause liver failure, which is now the major cause of death among AIDS patients.

And now you know about that, too.

Look into "ACTG 076" for information about AZT studies on children. Two versions of these trials exist: the story about the studies being terminated because the drug's effects were so miraculous, and the other one about the studies ending when people pulled their kids out because they didn't want them to die. Harlem, South Bronx, the usual people.

Happy "AIDS Awareness Month."

Thursday, December 7, 2006 09:00 AM

The Key Issue is Consent

Did these poor women know they were part of a clinical trial? If so, then that's how it goes in clinical trials -- some people get placebos.

If not, then even the women got non-placebo drugs have been wronged, because they got drugs that were only in the testing phase and not approved by the FDA for wholesale use.

Thursday, December 7, 2006 09:35 AM

aspirational anorexia?

a vast majority of americans are overweight. a good portion are obese. they will die very young unless they develop 'aspirations of anorexia' as you call it. disgusting. why not advocate smoking crack while your at it?

Thursday, December 7, 2006 10:32 AM

Consent

Consent is largely influenced by social and economic factors. Many people in developing countries consent to clinical trials because doing so is the only possible way to access necessary drugs kept at out of reach prices by big pharma. The same thing happens in the US, where health is also a commodity. Desperate people consent to all sorts of things that aren't ethical.

Thursday, December 7, 2006 10:53 AM

Samantha B

Carol Lloyd didn't even write the piece about Hitchens. And you're in the comments section for big pharma, not comedy. These facts don't give me alot of faith in the allegedly logical foundations of your opinion.

I am so sick of my blogs being invaded by right-wingers in liberals' clothing! There are people who actually get PAID to come to places like this and pretend to be liberals, all disheartened and disappointed with other liberals. You would think they would have to do a better job at it in order to continue getting paid. But who am I kidding? George Bush himself is still in office....

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