Court: Amgen within rights to deny drug

[question everything]

Los Angeles Daily News

Court: Amgen within rights to deny drug

By Brent Hopkins
Staff Writer

THOUSAND OAKS -- A federal judge handed Amgen Inc. a victory, ruling this week that the company does not have to continue to provide a Parkinson's drug to a pair of former trial participants.

The biotech company has been fighting with two former patients since April, when they filed suit to force the drugmaker to keep giving them the drug known as GDNF. Judge Kevin P. Castel of the U.S. District Court in Manhattan ruled late Monday that Amgen had no obligation to supply the drug, since patients had signed forms acknowledging its right to terminate the trials last September.

(snip)

Amgen halted tests of GDNF, shorthand for glial cell line-derived neurotrophic factor drug, on 48 patients last year after more than a year of tests. Saying trials showed no meaningful improvement for patients and could potentially lead to harmful side effects, the biotech firm encouraged patients to pursue other therapies to confront the disease.

(snip)

http://www.dailynews.com/Stories/0,1413,200~20950~2908891,00.html#

Brent Hopkins, [phone] [e-mail]

[Tempest]

1. Cheap bastards

It's only TWO people for God's sake.

[short bus president]

3. yes, by all means, let's establish production lines for those two

and keep them plied with a drug that has been shown highly unlikely to yield any positive results for them or anyone else with the disease.

:eyes:

Drug companies are cheap bastards, and are often evil entities, but this suit was a joke, brought by a pair who are grasping at straws. Even better - grasping at placebo-equivalent straws.

[Tempest]

5. They'll throw out more than what the two can use in a lifetime

They don't just make enough for the trial, you know.

They wouldn't have to produce any more of it.


And for all you know, the drug had a positive effect on the two and helped their conditions. Maybe that's why they brought suit.

[Bridget Burke]

2. If drug companies distribute drugs that cause harm, they are criticized...

And often sued.

Here's the summary from the Michael J Fox Foundation:

Patients in the trial received GDNF directly into their brains through tubes that led from pumps implanted in their abdomens. In the study of 34 patients announced in June, 17 patients received GDNF for six months while the rest received a saline solution.

At the end of the study, Amgen said it found no differences between the groups in performing such tasks as walking, talking and writing — even if some patients believed that they did improve.

Some physicians said the trial did not appear to work partly because patients received too low a dose of GDNF. So Amgen tested higher doses of GDNF in 15 monkeys, but some of the animals suffered irreversible brain damage. After receiving those results in September, Amgen stopped providing GDNF to patients.

www.michaeljfox.org/news/article.php?id=147&sec=4

Further studies are needed. Too bad the government can't cough up more research money so we don't have to depend on drug companies to do it all. But we've got a war to run & tax cuts to maintain.

[OzarkDem]

7. Further research

will probably be funded if it looks promising. Sounds like its back to the drawing board to possibly find a new trial design, dosing change, etc.

It sounds in this situation as if it would do more harm than good to continue treatment, particularly outside of a clinical trial.

Research and clinical trials design take time, it has to be done properly.

[Dr.Phool]

4. If the drug doesn't work

Why the fuck do they still want it? With bad side effects.

I took part in a clinical trial a few years ago, and the deal was that if the drug performed well, we'd receive free treatment. Well, the drug didn't work. We were all disappointed, but everything was done in good faith. The drug at first seemed promising, but after 7 seperate double blind trials, there was no difference in the people taking the drug, or the people taking the placebo.

We were told, we'd be welcome to join future trials, under the same agreement.

on edit: One other thing. The 2 people who sued to this day, don't know if they had a placebo or the real drug! According to the rules of double-blind studies, the blind can only be broken for that individual in case of a medical emergency.

[question everything]

6. I think that with Parkinson's and with others the effect

can be subjective; it is how one perceived the symptoms. And, of course, there is always the placebo effect.

Another thing is the statistical significance which has always angered me. It can be found that, say, only 3 out of 1000 show benefits. This would be considered statistically insignificant for most tests. But what if you are one of the 3, and if we are talking about terminal cancer?

I remember a program from the late 80s - if 27 showed benefits it would have been significant but since only 26 did (I don't remember the size of the sample) it was rejected.


(edited for an extra word that was just there..)