Posted on 05/05/2004 8:27:33 PM PDT by neverdem
An advisory panel to the Food and Drug Administration said yesterday that more study would be needed to determine whether Amgen's and Johnson & Johnson's widely used anemia drugs for cancer patients can actually make their cancer worse. But the committee did not discuss placing any restrictions on the use of the drugs or additional warnings on their labels.
Johnson & Johnson's Procrit and Amgen's Aranesp are used to treat the anemia caused by chemotherapy. The products are among the best-selling drugs in the world, with annual sales of several billion dollars.
Concerns about the drugs' safety arose last year after two clinical trials showed that cancer patients taking similar drugs in Europe did not live as long as those in a control group, suggesting that the anemia drugs might make cancer worse. Patients taking the anemia drugs in those trials and in some others also experienced higher levels of life-threatening blood clots, prompting Johnson & Johnson to stop some clinical trials of Procrit last fall.
At the advisory panel meeting yesterday in Gaithersburg, Md., executives from the two companies argued that the European studies were flawed. Each company said it had reviewed the records of its clinical trials and found no evidence that the drugs impair survival. They also said the blood clots tended to occur when the drugs were used at levels higher than indicated on the labels.
The F.D.A. panel, however, was not that easily dissuaded. "We have these evolving safety concerns; they cannot be dismissed," said Dr. Harvey Luksenburg, a medical reviewer for the agency.
Both drugs are genetically engineered versions of erythropoietin, or EPO, a human hormone that spurs production of oxygen-carrying red blood cells. Anemic patients have low levels of oxygen in their blood, causing fatigue.
Some cancer cells, however, have proteins, called receptors, to which EPO can bind, possibly stimulating the cells to grow. Some experts said yesterday that such stimulation did not seem to occur but that more study was needed.
Both companies said they had begun trials that could tell whether the anemia drugs worsen cancer or impair survival. The trials were actually begun to see whether the drugs improve cancer survival, on the theory that delivering more oxygen to tumors can improve the effectiveness of radiation therapy or chemotherapy. But the companies said the trials would also be able to detect lower survival rates.
Eric Ende, a biotechnology analyst at Merrill Lynch, called the meeting "benign," saying he did not expect any changes to the labels of the drugs until more data was obtained.
Shares of Johnson & Johnson fell 13 cents, to $54.80, while Amgen stock slid 24 cents, to $57.70.
But for the grace of God go I.
I don't get it. J&J stops their clinical trials because they think they might be endangering their patients. OK, sounds good to me
Then they find the European studied flawed. OK, they had a chance to review it.
Why didn't they just restart the original trial and have let it run for the amount of time they originally thought they needed to study it throughly? Extrapolating data over a shorter period of time in something like this isn't as accurate.
I don't agree with the the bad rap "evil" drug companies are getting from our socialist press but I still think there were reasons to run a trail for a specific amount of time and they should follow through with the original plan
Concerns about the drugs' safety arose last year after two clinical trials showed that cancer patients taking similar drugs in Europe did not live as long as those in a control group, suggesting that the anemia drugs might make cancer worse. Patients taking the anemia drugs in those trials and in some others also experienced higher levels of life-threatening blood clots, prompting Johnson & Johnson to stop some clinical trials of Procrit last fall.
Statistically speaking, those results suggest according to probability that the increased mortality would be found according to chance less than 1 out of 20 times in each study. People with most, if not all cancers, have an inherent tendency to blood clot formation. Apparently the drug worsened the tendency. Autopsies would help.
I don't agree with the the bad rap "evil" drug companies are getting from our socialist press but I still think there were reasons to run a trail for a specific amount of time and they should follow through with the original plan.
Their original intention was to help. Ethically speaking, when the numbers are so "out of the box" that it looks like they're doing harm, then they have a duty to stop the study. This happened recently with a study of hormone replacement therapy(HRT) in women.
Sure sounds like like it but I don't see that their numbers were "out of the box" but Europe's were.
The point is they seem to have now nixed their "original intention" and are fighting to keep the drug on the market!
It should be kept on the market for patients with kidney failure and anemia of chronic disease. The question is this a statistical anomaly, or in what cancer patients with anemia of chronic disease should erythropoetin(EPO) should be avoided.
It's time for bed. Good night.
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