Amgen and Johnson & Johnson are paying hundreds of millions of dollars to docs every year in return for giving their patients anemia meds, which regulators now say may be unsafe at commonly used doses, The New York Times reports this morning.

This is what the story says: The payments are in the form of rebates and are legal, but very few people outside of the docs who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give docs an incentive to prescribe the meds at levels that might increase patients’ risks of heart attacks or strokes.

Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for docs and centers. The payments have risen over the last several years as the drugmakers compete for market share and try to expand their business.

Neither Amgen nor Johnson & Johnson has disclosed the total amount of the payments. But documents given to The New York Times show that at just one practice in the Pacific Northwest, a group of six cancer doctors received $2.7 million from Amgen for prescribing $9 million worth of its drugs last year.

Yesterday, the FDA medical reviewers released a report suggesting usage may need to be curtailed in cancer patients. They cited a lack of evidence to indicate the drugs either improve quality of life or extend survival, while several studies suggest the drugs can shorten a patient’s life when used at high doses. The FDA already issued Black Box warnings in March, and a panel meets tomorrow to review usage.

Len Lichtenfeld, deputy chief medical officer of the American Cancer Society, said that both patients and doctors would benefit from fuller disclosure about the payments and the profits that doctors can make from them. “I suspect that Medicare is going to take a very careful look at what is going on here.”

Federal laws bar drugmakers from paying docs to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs.

The rebates inevitably encourage use of the drugs, said Michael Sullivan, who for nine years worked as a business manager for the group of six cancer docs in the Pacific Northwest, before losing his job last year. He provided The Times with documents showing the size of the rebates.

“Personally, I think rebates should go away,” says Sullivan, whose father was a kidney dialysis patient who died of a heart attack while taking one of the anemia drugs. “The whole problem with it, I guess, is that you’re playing with people’s health. It’s not the same as buying widgets.”

Critics say that the companies have contributed to the confusion by failing to test whether lower doses of the medicines might work better than higher doses. “The burden of proof is for companies and industry to demonstrate that a drug is safe at a certain level,” says Ajay Singh, an associate professor at Harvard Medical School.

As Pharmalot has indicated previously, the issue is further clouded by ties some docs have to the manufacturers. For instance, the National Kidney Foundation panel that recently issued guidelines boasts nine of 16 members with financial links to Amgen. And two months ago, the Renal Physicians Association, which is funded, in part, by Amgen and J&J, urged members to be cautious about the FDA warnings.

Lichtenfeld of the ACS tells the Times: “We shouldn’t condemn every oncologist; we shouldn’t condemn the drugs, because of the situation we’re in now.” He’s right. But there’s absolutely no oversight and patients are relying on their docs to make the best choices based on health, not incentives. Some of these docs and their professional groups appear to be out of control.

You can read the full story here (registration required).[tags]Amgen, Aranesp, Conflicts Of Interest, Epogen, Johnson & Johnson, Procrit[/tags]