While the jury is still out on the ultimate safety of anemia drugs Procrit and Aranesp, and the potential dangers they allegedly pose for cancer patients, new data from a meta analysis to be published today in the Journal of the American Medical Association (JAMA) suggests the jury will remain aloof for at least another few weeks.

That's when an expert panel will be convened by the US Food and Drug Administration (FDA) to debate the merits of the drugs, manufactured by Amgen.

While it has been suspected for some time that Procrit and Aranesp pose a risk to cancer patients weakened by chemotherapy, this latest study not only appears to confirm what has been suspected, but tips the balance into the danger zone.

Procrit, sold under license from Amgen by Johnson & Johnson, was approved for use in cancer patients in 1993. Aranesp was given the nod in 2002. Both drugs were approved based on a capacity for the reduction of the need for blood transfusions.

However, as is often the case when a drug is studied in an effort to win approval from the FDA, the studies were insufficient in duration and breadth to accurately address a patient's longevity.

Indeed, initially it was believed that the drugs would allow a patient to live longer. A meta-analysis conducted by the Cochrane Collaboration and published in 2004 discerned that patients who were given the drugs tended to live longer.

That no longer appears to be the case, once new data is averaged in. Some of that data came from Cochrane itself, the international research group which found two years later that patients using the drugs carried a higher risk of death by eight per cent. However, the 2006 meta-analysis just missed being statistically accurate.

Still, a trend seemed to be developing. Studies originally designed to show that higher doses would prolong life, actually demonstrated the opposite. As more studies were done and additional data factored in, the results first suggested by the Cochrane study of 2006 were suddenly beginning to achieve statistical significance.

Last year the FDA ordered stronger warning labels after it was found that using the drugs too aggressively posed a risk to cancer patients. Procrit, or Aranesp use could worsen their conditions, or even hasten death.

The latest data, published today by JAMA, serves as a confirmation of what is already known, or suspected.

The question now, is what will the FDA decide when it meets on March 13th?

The latest study, as summarized in this morning's edition of the New York Times, combines data from 51 clinical trials involving 13,611 patients. Although the study also found a 57 per cent increased risk for the development of blood clots in veins, Dr. Charles L. Bennett of Northwestern University and lead author of the study suggests that in his opinion blood clotting was not the foundation for higher risk of death. Rather, in his view, the drugs foster tumor growth.

Procrit and Aranesp are synthetic forms of the natural hormone erythropoietin. Dr. Bennett, an oncologist and hematologist, suggests there is evidence that the drugs directly stimulate the growth and spread of tumors, although Amgen scientists dispute that claim.

If the drugs allegedly prove dangerous in cancer patients when used at dosages higher than what is suggested on product labels, the question remains whether or not the drugs are safe when used at prescribed levels. The FDA will most assuredly be debating that issue on the 13th of next month, along with the potential to restrict their use in certain cancer patients such as patients suffering from breast cancer, or cancers affecting the head or neck.

Another possibility is the delay of treatment until a patient's anemia reaches a more pronounced threshold.

The fact remains, however, that Aranesp and Procrit, according this latest meta analysis, raise the risk of death amongst cancer patients by about 10 per cent, which is cited as statistically significant.

The anemia drug Epogen, manufactured by Amgen and similar to Procrit but aimed at kidney dialysis patients, is not expected to enter into discussions.

Aranesp, Epogen, and Procrit Legal Help

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A new black box warning announced yesterday by anemia drug maker Amgen comes on the heels of recent data which suggests increased incidence of death, and accelerated tumor growth amongst patients with certain types of cancer.

The warning applies to Aranesp, Epogen and Procrit—drugs that are designed to fight anemia and are often prescribed to cancer patients undergoing, or having undergone chemotherapy.

The drugs are also used in patients suffering from kidney failure.

The toughened black box warning, updated in concert with the US Food and Drug Administration (FDA), arrives just a week before the FDA convenes an expert panel to further scrutinize the drugs. It is not known what stance the FDA will take, but there are several possibilities. The FDA could recommend that certain cancer indications be removed. Or, the panel could recommend that the anemia drugs in question not be used in cancer patients altogether.

The concern stems primarily from higher doses of the drugs, which appear to elevate red blood cells.

Amgen, based in Thousand Oaks California, manufacturers Aranesp, Epogen and Procrit—although the latter is licensed to, and marketed by Johnson&Johnson. The new warning label refers to the fact that dosage levels higher than those recommended tend to be consistent with the concerns identified, together with increased death and tumor growth in patients suffering from early stage breast and cervical cancers.

Previous label updates, the latest coming in November, warned of similar risks for other types of cancer.

The performance of Amgen's anemia drug trio has stalled since last March, when the FDA first began scrutinizing them. The label update in November was quickly followed by the release of new data in December pointing to risks for patients with early stage breast cancer and cervical cancer.

Sales have been falling since March of last yaer, and could take a further hit if Medicare scales back anemia drugs yet again. Last summer Medicare altered its policy to only pay for drugs if they were prescribed at low levels. Industry analysts say that Medicare could impose further restrictions, reducing sales even more.

It is believed that any recommendations coming out of the FDA panel discussions next week should not affect Epogen, as it is used primarily with kidney dialysis patients.

Over the last year, it has been reported that sales of Amgen's trio of anemia drugs have fallen 10 per cent, while shares in the company are down 27 percent.