Share The Wealth by Chris Gupta
January 03, 2004

In the FDA we trust?


..."Last Daily Dose, I spilled a story that many in the medical mainstream (and the drug companies they're slaves to) would no doubt love to keep under wraps: A possible link between antidepressant drugs and suicide in depressed juveniles.

But the ironic part of the story was that the red flag on this potential link is being hoisted not by a marquis medical journal, some big-name investigative reporter, or even a law firm representing a class action suit on the matter - but rather by the ponderous U.S. Food and Drug Administration, normally the willing handmaiden of the prescription drug industry."...

Some cogent comments from Dr. Douglass...

Chris Gupta

Daily Dose

December 26, 2003

**************************************************************

The suicide squeeze (Part 1)

For all the ink I've expended on the subject of antidepressants in the last two years or so (in both the Daily Dose and in my newsletter), I still can't seem to stay ahead of the stunning torrent of negative information out there about these drugs. Really, there's so much flotsam floating to the surface about prescription antidepressants nowadays that even the drug-happy mainstream is being forced to report it. Here's the latest in the "happy-pill" soap opera...

It turns out that in addition to the laundry list of other side effects of prescription antidepressants (to name just a few: headaches, skin rashes, nausea, diarrhea, sexual dysfunction, back and joint pain, tremors, and yes, even anxiety), some within this class of drugs have been linked to an increased likelihood of - you guessed it... Suicide.

Now that's one way to cure depression once and for all, huh?

According to articles in Reuters and the Associated Press, the U.S. Food and Drug Administration is now sounding the alarm to doctors nationwide about recent reports that show certain classes of antidepressant drugs may actually spur some profoundly depressed children and young adults to take their own lives.

I could name some of these medications, but to do that would shift the focus to a few specific drugs instead of an entire class of 20 or more prescription antidepressants, any and all of which might contribute to this effect. Remember, even though only one such drug is currently approved for treating juvenile depression, many others designed only for use in adults could be being prescribed to minors by any number of doctors - all perfectly legally.

Drug makers will no doubt be quick to point out that establishing a conclusive link between suicide and antidepressant drugs is nearly impossible, since the very patients who take such drugs themselves represent the single greatest at-risk group for suicide. How could anyone pinpoint causation in such a group?

But this argument leads to the really disturbing part of this drama (as if drugged-out kids killing themselves isn't bad enough). Learn all about it in the next Daily Dose...

Daily Dose

December 30, 2003

**************************************************************

The suicide squeeze (Part 2)

Last Daily Dose, I spilled a story that many in the medical mainstream (and the drug companies they're slaves to) would no doubt love to keep under wraps: A possible link between antidepressant drugs and suicide in depressed juveniles.

But the ironic part of the story was that the red flag on this potential link is being hoisted not by a marquis medical journal, some big-name investigative reporter, or even a law firm representing a class action suit on the matter - but rather by the ponderous U.S. Food and Drug Administration, normally the willing handmaiden of the prescription drug industry.

Which should lead you to ask: Why?

To understand the answer to this question, you need to know how the FDA finds out about a drug's side effects. It might surprise you to learn (but probably not) that after the approval process - during which a drug's side effects are disclosed by the selfless and honorable drug makers themselves - the only way the FDA EVER DISCOVERS the side effects of any particular drug is if individual doctors take the time to document and report them from the field.

That's right. If sufficient numbers of doctors don't squawk about the unknown (or undisclosed) side effects of an approved drug, the FDA won't find out about them. And even once they do know about these downsides, how likely do you think it is that they'll sound the alarm about a drug's dangers, knowing full well that the egg will be on their face - along with a bunch of lawsuits?

The way I see it, such a disclosure would ONLY HAPPEN if the public danger were significant enough for the FDA to feel the need to control their own liability by preventing additional cases from occurring. It's a simple dollars and cents equation. If it'll cost them less to stay quiet than to sound the alarm, then mum's the word. If not, they notify doctors and the Associated Press.

But the scariest part of it all is this: The FDA has no real idea of the scope of the antidepressant/suicide link. In fact, it's a wonder they learned of it at all. After all, how many doctors do you think are likely to willingly volunteer the fact that one or more of their patients killed themselves after taking antidepressants they prescribed - especially if it's a medication other than the one drug currently approved for juvenile depression?

This tells me that the risks are very real, and much greater than they appear.

Thank God there are a few honest doctors out there who still believe in their oath and their duty to their fellow man enough to speak out about it. I tip my hat to them...

 


posted by Chris Gupta on Saturday January 3 2004
updated on Saturday September 24 2005

URL of this article:
http://www.newmediaexplorer.org/chris/2004/01/03/in_the_fda_we_trust.htm

 

 


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Readers' Comments


There are some things you should be aware of. First, pharmaceutical companies routinely conduct Phase IV studies, after a drug is marketed, in order to provide further information about safety. This is called postmarketing surveillance.

Second, the FDA Medwatch program is the program that is used to report possible adverse outcomes from use of drugs or medical devices. Material submitted via the Medwatch program cannot be used in a lawsuit. By law, documents from medical programs that are intended for internal investigation of negative outcomes cannot be introduced as evidence.

Thus, doctors and hospitals can report anything they want to the FDA, without exposing themselves to liability.

Third, the risk of suicide among patients taking antidepressants is not news. This has been discussed, evaluated, and researched for decades.

Fourth, there is no evidence that anyone is trying to keep this under wraps.

Fifth, You are correct that there are significant liability issues here, but the FDA itself is not likely to face any liability.

Sixth, it was not the FDA that first sounded the alert. There were several studies done that have led to the concern. These were reported to the appropriate regulatory agencies, and those agencies have started to do exactly what they should do in these circumstances.

This is not to say that we should ignore the reports. On the contrary, there is much work to be done to find out what has gone wrong and what has been done right. It appears that the health care industry may have pushed ahead too quickly with expanding the use of antidepressants in children. And it is possible that the pharmaceutical companies played a role in this. But the pharmaceutical companies were among the first to come forth with the reports that have generated so much concern.

For a good review of the topic, see

http://www.cmaj.ca/cgi/content/full/170/4/489#R4-28

Posted by: Joseph on March 24, 2004 06:13 AM

 


There are some things you should be aware of. First, pharmaceutical companies routinely conduct Phase IV studies, after a drug is marketed, in order to provide further information about safety. This is called postmarketing surveillance.

Second, the FDA Medwatch program is the program that is used to report possible adverse outcomes from use of drugs or medical devices. Material submitted via the Medwatch program cannot be used in a lawsuit. By law, documents from medical programs that are intended for internal investigation of negative outcomes cannot be introduced as evidence.

Thus, doctors and hospitals can report anything they want to the FDA, without exposing themselves to liability.

Third, the risk of suicide among patients taking antidepressants is not news. This has been discussed, evaluated, and researched for decades.

Fourth, there is no evidence that anyone is trying to keep this under wraps.

Fifth, You are correct that there are significant liability issues here, but the FDA itself is not likely to face any liability.

Sixth, it was not the FDA that first sounded the alert. There were several studies done that have led to the concern. These were reported to the appropriate regulatory agencies, and those agencies have started to do exactly what they should do in these circumstances.

This is not to say that we should ignore the reports. On the contrary, there is much work to be done to find out what has gone wrong and what has been done right. It appears that the health care industry may have pushed ahead too quickly with expanding the use of antidepressants in children. And it is possible that the pharmaceutical companies played a role in this. But the pharmaceutical companies were among the first to come forth with the reports that have generated so much concern.

For a good review of the topic, see

http://www.cmaj.ca/cgi/content/full/170/4/489#R4-28

Posted by: Chris Gupta on March 25, 2004 09:21 PM

 















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