Promised tests remain undone for many FDA-approved drugs

[question everything]

Promised tests remain undone for many FDA-approved drugs

By Gardiner Harris
NEW YORK TIMES NEWS SERVICE

March 4, 2006

WASHINGTON – When the Food and Drug Administration approves new drugs for sale, it often requires their manufacturers to study whether the medicines are working as intended and whether they have unwanted side effects. But yesterday, the agency reported that two-thirds of the studies hadn't even been started.

Hundreds of studies have been pending for years, with one dating to 1955, the FDA said. In many cases, pharmaceutical makers promised to undertake the studies as a way of speeding their drugs' approval. The FDA said yesterday that drug companies had pledged to conduct 1,231 drug studies. But 797 – or 65 percent – had not begun or were “pending” as of Sept. 30. Critics of the industry promptly seized on the new numbers, saying they demonstrate that the FDA needs more power to compel drug makers to follow through on needed studies.

(snip)

One problem is that the promised studies are often difficult to complete. For example, few cancer patients would willingly risk enrolling in a study that might result in them receiving a placebo when the active drug is easily available at any oncologist's office. As a result, just one cancer medicine in five has ever proved that it extends patients' lives – the usual endpoint demanded of post-approval cancer trials.

The promised trials are also expensive, and drug makers sometimes have few incentives to complete them. The FDA's only recourse in such a case is to withdraw the drug, but because such a step might hurt patients, it's considered so Draconian that regulators have never taken it over a failure to complete a study.

(snip)


Find this article at:
http://www.signonsandiego.com/uniontrib/20060304/news_1n4drugs.html

[Divernan]

1. Particularly egregious lapse re fertility drugs

According to my pharmacist source, and my personal knowledge of women developing multiple (fatal) cancers immediately concommitant with taking fertility drugs. They DID live to bear their kids, but died within a year of the births. But the fertility clinics count these babies as "successes" when they tout their success rate. You see, once a drug is approved by the FDA, even though it is ostensibly for a particular limited dosage for a particular narrow problem, and even though it has NEVER BEEN TESTED for larger dosages or in combination with other powerful drugs, or for the effect IT MAY HAVE IN UTERO on fetuses, physicians can prescribe said drug in ANY amount, for ANY stated medical purpose, and regardless of what other drugs are being taken simultaneously. My pharmacist friend told me he was horrified the first time a woman handed him a batch of prescriptions from her fertility doctor. British medical journals have described the treatment of infertility in the United States as the Wild West of medical frontiers. Unfortunately, huge profits can be made from people so desperate to have children and who either refuse to educate themselves or choose to ignore the risks the mother takes. Another great concern is what effect these drugs are having on the children born of these mothers - particularly as they go through puberty. And no studies are being done about this.

[question everything]

2. These are horror stories

how come no one has ever done an investigative reporting about this?

[Divernan]

4. I researched the topic re some proposed legislation in Pennsylvania.

The history is that when the field of fertility treatments in the US was first getting established, docs tried to get government grants/funding. The conservatives, who viewed many fertilization procedures as equal to abortions (throwing out unused fertilized eggs, for example), blocked any govt. funding. Therefore there is no govt. oversight of the programs. And the fertility bidness quickly found that there are plenty of people whose life evidently has no meaning unless they can pop out their very own baby. I mean we are talking spending tens of thousands of dollars per couple. So the clinics are making a shitload of money. They make so much money in fact that they have banded together and are funding big time lobbying efforts in every state. Their goal is legislation which would force health insurers to cover these voluntary medical treatments. So you basically have Godzilla versus King Kong. This is a situation which legislators just love. See, the lobbyists give one group of legislators fat contributions to introduce this legislation (which the lobbyists have personally drafted), and then the opposing interest group/corporations gives another group of legislators even bigger bucks to block the legislation. The keyman or woman in this is the Majority Committe chairman of whatever committee the bill is submitted to for initial consideration. This one person has the power to hold up legislation indefinitely.

Anyway, I was able to research the topic in just a few days. Although there are no studies of the longterm negative impacts on mothers and babies in the US, there are articles in very respectable foreign medical journals detailing the precautions more civilized countries take to control fertility clinics and basically protect the desperately-seeking-babies parents from themselves.

[sam sarrha]

3. i was given Strattera without any testing, it is EVIL.. ..see LINKS>>

http://www.laleva.org/eng/2006/01/eli_lillys_and_christopher_gillbergs_failed_experiment_with_strattera.html

http://www.ritalindeath.com/ADHD-Drug-Deaths.htm

http://www.ritalindeath.com/Strattera-Suicide.htm\

i began to be insidiously drawn into a dark hopeless world where everybody was dong to be dead, and the 'going to be' was becoming nebulous.. i would not be able to deal with the bodies, i am 57 with a bad back, and would have to make plans to abandon the house and couldn't figure where to go.. because everybody was going to be dead there too... i would just have to find a place and sit and wait for death.. i had trouble getting outof bed in the morning with these fantacys.. i am much worse now, i have blackouts and lose things much worse than before, and i am very depressed.. nearly nonfunctional

i was never diagnosed with ADD/ADHD or what ever.. my orthopedist gave it to me.. it ends up being i have Aspergers Syndrome and am autistic

just Google ... Strattera failed drug..

i heard over 300 people and many of them children have died taking Strattera or drugs like it..

many of heart problems.. SUDDEN DEATH SYNDROME.. i am Clairvoyant, so maybe that was it .. it was going to kill me.. i had an irregular heartbeat taking it.. maybe soon after stopping