Does Pharma Have a Constitutional Right to Push Dangerous Drugs?

Two contrasting news stories illustrate the ups and downs in the crucial David vs Goliath battle to contain the dangerous greed of drug companies.

Score one for David that two California counties are suing five makers of prescription narcotic drugs for their illegal and unethical off-label marketing practices.

This is a life and death issue -- doctor prescribed drugs cause more overdose deaths than all the deaths caused by cartel pushed street drugs.

The drug companies are only marginally better than drug pushers -- in it for the big bucks and callously oblivious to the collateral damage they inflict on individuals and on society.

Once, they get FDA approval for a narrowly targeted pain killer indication, the drug companies turn loose the sales force to mislead doctors into prescribing the pain pills far more broadly than intended, in ways that have not been tested or approved and do far more harm than good.

We are distracted by the fuss over legalizing pot (which is not in fact a very dangerous drug), while blithely ignoring what is the very real and present danger -- the avoidable addiction of millions of people to legal opioids, illegally promoted by unscrupulous drug companies.

Previous seemingly huge fines for their blatantly illegal marketing practices have been shrugged off by the drug companies as the cost of doing business, mere chump change. And the Food and Drug Administration is a toothless pussy cat, completely unable to protect the public from the deaths and despair caused by Pharma malfeasance.

What is needed now are massive lawsuits with financial penalties big enough to get the attention of the drug companies and to contain their greed. This worked in the battle against Big Tobacco and it can work also to tame Big Pharma.

But Pharma won't give up its enormous cash cow without a fierce fight. It enters the fray with one of the biggest and best connected lobbying efforts in Washington, a ton of cash to buy politicians, expensive legal talent, and no end of chutzpah.

Pharma's latest claim is a thing of absolute splendor -- that it has a constitutional right of 'free speech' that allows it to market off-label indications to doctors, however misleadingly and with whatever disastrous consequences. To its great shame, the American Medical Association is supporting Pharma in this latest outrageous power grab.

Seventeen years ago, Pharma used a related restraint of trade argument to bully politicians and bureaucrats into granting it the unprecedented right to advertise directly to consumers. New Zealand is the only other developed country in the world that gives Pharma this ability to shanghai proper medical practice with slick peddling tricks.

It is time to restrict Pharma's freedom of speech, not expand it. Medical treatment should be governed by the best available science and a do-no-harm common sense caution -- and not be corrupted by corporate huckstering and greed.

Let's hope that the continuing string of Pharma outrages and scandals provokes a righteous and effective backlash. We are fighting the wrong war on drugs. Containing Pharma should be our number one public health priority.

Allen Frances is a professor emeritus at Duke University and was the chairman of the DSM-IV task force.