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Dr. Frankenstein's Monster: A Creation Of Congress
Barry Meier writes for The New York Times of a bill Congress passed last month, making drug and medical device makers disclose results of clinical trials for all approved products. What got dropped from the bill? The bit about disclosing results of clinical trials for all products tested on patients, but dropped before marketing. And for some patients, that's where all the fun starts:

Many experts said the recent Congressional debate underscored a troubling fact: some patients in clinical studies never learn about test results. The problem may be particularly relevant to those implanted with medical devices that stay with them long after a trial is over.

In August, for example, the Food and Drug Administration sent a warning to Boston Scientific after investigators discovered the company’s diligence in following up with patients faltered around the time it dropped a product under development.

The product being tested was an experimental stent intended to prevent the rupturing of an aneurysm in the major abdominal artery.

Among other things, agency investigators found that Boston Scientific, which halted development of the stent last year after a study showed it frequently fractured, had neglected to tell patients in that trial about the problem’s scope.

Researchers involved said such a fracture, while not dangerous in itself, could cause a stent device to shift position, thus rendering it useless in treating an aneurysm, a weakening of a blood vessel that can burst with fatal consequences.

Paul Donovan, a spokesman for Boston Scientific, said that the company was moving to address the F.D.A.’s concerns. While six patients involved in the study have died, Mr. Donovan said that the company did not believe that those deaths were related to either the stent or burst aneurysms.

“There were instances of reporting that was not done in a complete and timely manner, and we are addressing these shortcomings,” Mr. Donovan said.

Well, isn't that special. Luckily, some patients do find out about the problems with their test devices -- entirely by accident:

That apparently is what happened last year when two women struck up a conversation at a hospital in Tampa, Fla., and found out that they were both there for the same reason: severe pain, related to their breast implants.

As they talked, the women, Christina Rafsky and Barbara Padgett, learned they had more in common. Both had seen the same doctor in Tampa, who had persuaded them to participate in a clinical trial he was overseeing of a new type of silicone-filled implant made by Inamed Aesthetics, now a unit of Allergan.

Next, a curious Ms. Rafsky called Allergan and learned for the first time that Inamed had halted that trial in 2005 because the implant model she had received was rupturing.

Their doctor claimed not to have gotten the letter telling him so:

As to whether Dr. Mosiello received the Inamed letter in 2005, the University of South Florida panel, which interviewed both Dr. Mosiello and an Allergan official, found that “there was no documentation or recordkeeping regarding who had been contacted and when,” its letter states.

While I'm disparaging of the people knee-jerk-criticizing "Big Pharma" (like the "health food" industry is in it for the luvvvv), there's far too much blind trust of doctors and drug companies. Buyer beware -- no matter who you're buying from. And especially, of course, when somebody tells you you're getting something for nothing. And then dumps it into your bloodstream or cuts into you to give it to you.

P.S. But, do thank your Congresscritter for looking out for your welfare -- well, whenever it doesn't get in the way of the that of the drug companies.

Posted by aalkon at October 31, 2007 10:53 AM

Comments

Wouldn't it just make sense to follow up on the results of any study you were participating in? I presume the fear is the dreaded lawsuit if companies made an effort to contact all trial participants. Surely the waiver patients sign would protect them. Although it could still result in legal costs as someone would decide the company knowingly carried out the trial even though they knew the product was bad. Time consuming and expensive. I see a made for TV movie in there for sure!

Posted by: moreta at October 31, 2007 7:54 AM

This will do nothing not protect children. Ritalin, Paxil, Wellbutrin, Lithium - non of them tested on children.

Children's cough medicines (the ones that we ere just told do no actual good and may harm kids) - not tested on children.

Doctors decided that it was unethical to use children in drug trials, so they just put out smaller doses of the stuff that adults tolerate, and call that good for kids.

Posted by: Chris at November 1, 2007 7:24 AM

Greetings all,

I know this subject could go around in circles forever however, for me my story goes way beyond this trial study.
I had a grandmother who had breast cancer twice and a mother who had breast cancer once and then died of ovarian cancer Two years ago. I then decided to get tested for the cancer gene (brca2)
and guess what? I had it!
This was an easy decision for me, Double Prophylatic Mastectomy. I know many of you would think I am nuts however, this thing started to take over my life. I always had abmormal mamo's and always an "area of concern".
I decided to have my surgery and went to a top notch facility here in tampa. Unfortunately, the doctor that I saw for my reconstruction/expansion was not so top notch.

I am a mother of three small boy's, married and try to always take care of myself. For me, I had no alternative but to have "breasts" and I believe this is such a personal issue and "kudos" to those who decide not to go through with reconstruction however, this was not the alternative for me.

I did my research (so I thought) was all set to have my second phase of my reconstruction and somehow??? was talked into this trial study.
(long,long story)

I must say that I did all the investigating I could find on this study/implants however, at the time not much to find anywhere and I was truely not informed. I trusted my Doctor and the implant maker to make sure this was a safe study and to inform me of any issues regarding this trial. I believe that when a person participates in a trial study and the trial study
goes away, we have a right to access any/all information.

I also think that if a company removes a trial study device due to problems, don't we have a right to decide for ourselves weather we want to take them out of our bodies? How can we decide if once again, we are left in the dark?

Posted by: christina in tampa at November 4, 2007 5:36 AM

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