WHEN IT COMES to health care, no one should come between doctor and patient - not the government, and certainly not insurance companies.
But what if it's pharmaceutical companies that are blocking you from the most effective medical care - by misleading doctors so that they prescribe drugs for the wrong purposes? Worse yet, what if the doctors are getting kickbacks, in the form of golf or resort outings, to write those prescriptions?
That's just what's been happening for years throughout the pharmaceutical industry, even though it's criminal. Even when government - with the help of whistle-blowers - identifies the wrongdoers, punishments are weak and provide little deterrence.
The latest example: Early this month, the U.S. Justice Department announced the largest single criminal fine in history, and it was against pharmaceutical giant Pfizer Inc. The company agreed to pay $2.3 billion - $1.3 billion in criminal fines for illegally promoting several of its drugs for unapproved purposes, the rest to repay Medicare and Medicaid for improper charges.
Yet, even as various agencies of the government congratulated themselves for working together to catch Pfizer - for the fourth time in seven years - experts doubted that even this huge penalty would stop the industry-wide practice of "off label" marketing of drugs. It has become so profitable that even billions in fines can be absorbed as the cost of doing business.
There's nothing wrong if doctors prescribe drugs for purposes other than those approved by the Food and Drug Administration, but they are supposed to make those decisions based on information found in peer-reviewed medical journals. It is illegal for drug companies to market drugs for unapproved uses, yet Pfizer promoted the drug Bextra - which was FDA- approved for arthritis pain and menstrual cramps - as effective in relieving post-surgical pain, if used in higher-than-recommended doses. The higher doses were linked to increased risk of heart attacks and stroke, and Bextra was pulled from the market in 2005. In another instance, the company ignored orders from the FDA to stop promoting its antibiotic Zyvox as being superior to other drugs to fight certain bacteria. It also made improper claims for two other drugs.
According to the government, Pfizer was committing these crimes even as it was settling another case for illegally promoting a different drug, Neurontin. So much for tough enforcement.
As part of the recent case, Pfizer agreed to an "expansive corporate integrity agreement" in which the inspector general of the U.S. Department of Health and Human Services will keep a closer eye on the company.
But we agree with Sen. Arlen Specter and frustrated consumer advocates that penalties for breaking this law must become much harsher if behavior is going to change substantially.
What might help are a few well-publicized "perp walks" for executives charged with pursuing profits over patients - not to mention cheating the taxpayers by overcharging Medicare and Medicaid. At a recent meeting with this board, Specter promised to "raise hell" with the Justice Department over the case. We urge him to act now.
Meanwhile, consumer advocates say you can protect yourself by asking your doctor whether medication you're being prescribed is FDA-approved for your condition. It it's not, ask the doctor what evidence there is to support using it. We can protect each other as Americans by demanding that our elected leaders crack down on fraud as part of comprehensive health-care reform.