Case highlights little-know incentives to prescribe marginal remedies at high doses
by Craig Weatherby
Many natural health practitioners, such as acupuncturists, naturopaths, and chiropractors, sell supplements to their patients.
While most are ethical and well-intentioned, it seems inevitable that the judgment of some will be distorted by the profit motive. And Congress’ failure to fund research into safe, promising natural therapies allows entirely too much room for wishful thinking.
Still, given the relative safety of most supplements, any harm to patients would usually be limited to their pocketbooks and expectations.
A more disturbing, dangerous example of distorted judgment -- this one among medical doctors -- made headlines yesterday. And it highlights an unhealthful contradiction in public health policy and law.
On one hand, leading researchers must scrape and scramble to find funds to study dietary supplements that might help millions avoid or ameliorate major diseases.
In contrast, politicians and regulators seem overly eager to serve the interests of big pharmaceutical firms, even when it means approving marginal-to-useless drugs and giving doctors incentives to over-prescribe them.
The headline-making scandal involves three widely prescribed anemia drugs, and highlights a big loophole in the legal and ethical rules that don't allow doctors to profit from their prescriptions: one that seems to have led many to make dangerously bad medical judgments.
If, like us, you assumed that physicians were barred -- by law and medical ethics -- from profiting from the sale of treatments they prescribe to patients, think again.
Over-prescription of anemia drugs bleeds Medicare and endangers patients
Yesterday, The New York Times reported that pharmaceutical giants Amgen and Johnson & Johnson pay doctors hundreds of millions of dollars annually in return for giving their patients anemia medicines that may be unsafe at standard doses.
The three anemia drugs in question – Aranesp, Epogen, and Procrit -- rank among the world’s top-selling drugs, with combined sales of $10 billion in 2006.
They’re prescribed for about one million patients every year, to treat anemia caused by kidney disease or cancer chemotherapy, and represent the single biggest drug expense for Medicare.
The scandal arose because doctors who purchase them for patients can receive legal kickbacks – euphemistically called “rebates” – from the drug makers.
The paper reported that a group of six cancer doctors in the Pacific Northwest reaped $2.7 million from Amgen for prescribing $9 million worth of its drugs last year (The whistle was blown by the former manager of the group practice, whose own father was killed by one of the drugs).
Top cancer and kidney doctors told The New York Times that physicians often prescribe the drug at doses that raise a patient’s risk of heart attack or stroke. And they noted that the incentive provided by drug company kickbacks could be the reason.
Indeed, the average dose given to dialysis patients in the US has nearly tripled since 1991, and about half of all dialysis patients receive enough of the drugs to raise their red blood cell counts above safe levels.
And compared with their counterparts in Europe, American kidney patients receive doses of the drugs that are more than twice as high, while American cancer patients are about three times as likely to get the drugs, also at significantly higher doses.
Doctors can profit from prescriptions
Under US law, drug companies cannot pay doctors to prescribe drugs purchased subsequently by patients from pharmacies.
But few people – not including us – knew that doctors can profit when they purchase drugs that are prescribed and dispensed in their offices.
The profits come about because doctors can legally accept kickbacks from the companies that sell them the drugs. Doctors receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.
When added to insurance reimbursements, the kickbacks give many doctors a substantial profit on the medicines they buy to give patients.
The size of the rebates from a drug company relate to the volume of drugs purchased by a doctor, and rise if a physician promises to use the company’s drug exclusively.
FDA finds kickback-earning anemia drugs marginal at best
In March, the Food and Drug Administration (FDA) decided to strengthen the warnings on the drugs’ labels. And on Tuesday, the FDA released a report suggesting that prescription of the anemia drugs among cancer patients should probably be pared back.
FDA staff scientists found no evidence that the anemia drugs improved patients’ quality of life or extended their life spans. Instead, several studies indicate that they can shorten patients’ lives when used at high doses.
Today, an FDA advisory panel was scheduled to hold a hearing to consider whether the drugs are overused.
- Berenson A, Pollack A. Doctors Reap Millions for Anemia Drugs. The New York Times, May 9, 2007. Accessed online May 9, 2007 at http://www.nytimes.com/2007/05/08/health/08fat.html?ex=1179374400&en=7110e33dfd14cc66&ei=5070&emc=eta1.