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Sean Philpott: Punishing The Promoters

Earlier this week, the US Justice Department announced that pharmaceutical giant Johnson & Johnson agreed to pay more than $2 billion in fines and penalties for illegally marketing the drug Risperdal to doctors and patients.

For nearly seven years, pharmaceutical reps pushed this drug as a way to manage some of the behavioral issues, such as agitation or hostility, that are often seen in patients with dementia or developmental disabilities. Those problems make caring for these patients difficult, particularly in a nursing or group home setting.

The company also pushed the drug to treat some of the symptoms associated with attention deficit hyperactivity disorder (ADHD) and obsessive-compulsive disorder (OCD) in children.

However, the US Food and Drug Administration (FDA) only approved Risperdal for use in patients with schizophrenia and bipolar disorder. It was not approved for use in demented or developmentally disabled patients. Moreover, despite knowing that older patients were at increased risk of stroke when using the drug, Johnson & Johnson aggressively marketed the drug to gerontologists -- doctors who treat the elderly. The cardiovascular risks to patients, and the very fact that the drug was only approved to treat schizophrenia, were downplayed.

The $2.2 billion dollar settlement is, surprisingly, not the largest of its kind. In 2009, for example, the pharmaceutical company Pfizer was fined $2.3 billion for improperly pushing the painkiller Bextra. That drug was removed from the market when it was found to increase a user's risk of stroke nearly three-fold.

Similarly, just last year British drug maker GlaxoSmithKline (GSK) paid the US Justice Department $3 billion to settle allegations that it illegally promoted drugs like Paxil and Wellbutrin for unapproved uses. GSK also hid the fact that its anti-diabetes Avandia was linked to heart attacks.

In the last decade alone, over two dozen such cases have been settled and nearly $15 billion in criminal fines and penalties paid. One might hope that substantial penalties like these would dissuade pharmaceutical companies from inappropriately marketing drugs for unapproved and potentially dangerous uses.

Nothing could be further from the truth. A $2 billion settlement is simply seen as the price of doing business, and it barely makes a dent in drug companies' bottom line. In one year alone, Risperdal brought in over $3 billion in sales. Given that blockbuster drugs like Risperdal can dominate the market for a decade or more, the financial incentives to commit wrongdoing are immense.

Don't get me wrong. I am a strong supporter of the pharmaceutical industry. I believe that companies like Johnson & Johnson have every right to earn a profit by developing and distributing new drugs. It is that very incentive that leads to improvements in medical care and treatment, improvements that benefit all of us. But drug manufacturers should be allowed to put profits before patients.

As I have argued in the past, pharmaceutical companies have a legal and moral responsibility to ensure that their drugs are safe. This requires that they not only seek FDA approval to sell these drugs, but also that they abide by that Agency's rules for marketing these drugs to doctors and patients. Moreover, it also requires that they inform physicians and consumers about the potential risks associated with their use, rather than downplay or hide them as so often happens.

Although the US Supreme Court's ruling in Citizens United v. Federal Election Commission that corporations are people too, companies like Johnson & Johnson have no moral compass. In order to ensure that they meet their ethical obligations to patients, we as a society thus need to impose some form of conscience on these companies.

Despite what I implies earlier, financial penalties are the way to go. The problem is that the penalties imposed to date are not nearly enough. A $2 billion penalty is merely a slap on the wrist. We need to encourage the Justice Department to demand increasingly larger penalties -- in the range of $20, $30 or even $40 billion. These fines must substantially affect, or even eliminate, the profit that these companies earn from promoting inappropriate or unsafe use of drugs like Risperdal. Until then, it will simply be business as usual.

A public health researcher and ethicist by training, Dr. Sean Philpott is Director of Research Ethics for the Bioethics program at Union Graduate College-Icahn School of Medicine at Mount Sinai in Schenectady, New York. He is also Acting Director of Union Graduate College's Center for Bioethics and Clinical Leadership, and Project Director of its Advanced Certificate Program for Research Ethics in Central and Eastern Europe.

The views expressed by commentators are solely those of the authors. They do not necessarily reflect the views of this station or its management.

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