Pharmaceutical companies are prohibited from marketing drugs “off-label”

Although doctors are allowed to prescribe drugs for any use that they choose, pharmaceutical companies are strictly prohibited from marketing drugs for off-label uses. The prohibition hasn’t stopped them—in fact, most of the large drug companies have paid enormous fines in recent years for their off-label marketing schemes. The fines, however, are much less than the profit that was made by selling the drug for off label use. For this reason, this practice continues with drug companies, and they view the fines as a mere cost of doing business. And while some off-label uses for drugs have been studied and do make sense, many more have been found to be dangerous to patients as well as ineffective.

Why do companies decide to market drugs for off-label uses?

The easy answer to this one is “to make more money,” but the way that this practice benefits the manufacturer is actually a bit more complex.

Drugs make the most money for drug companies when:

1. They are new to the market and patented, so they cannot be copied
2. They are not duplicative of older drugs or easily imitated
3. They can be prescribed to a large body of consumers

Once a drug has aged and is “off patent,” copycats can be easily manufactured and marketed as generic versions. So the promotional window for any given drug is finite – and during that time, the manufacturer will race to sell as much of the drug as it possibly can, for as high a price as the market will bear.

For the pharmaceutical companies to maintain large profits, they need to continually bring new drugs to the market that can be sold to a large population. And while some drugs, like a drug to reduce cholesterol, are easily marketed to a large population, other drugs, like anti-psychotics, are a great deal more difficult to sell on a large scale.

Drug company representatives are taught to consider these drugs a challenge.

Risperdal, a drug in need of a larger population of consumers

Risperdal, a heavy-duty, anti-psychotic drug, was approved by the FDA in 1993 for the treatment of schizophrenia and bi-polar disorder in adult patients.

No doubt this seemed to the Johnson & Johnson drug reps to be a decidedly small population to be treating, particularly since Risperdal came with more complaints about side effects than any of the other drugs in its class.

They decided to branch out.

According to a complaint filed by the Justice Department, Johnson & Johnson reps targeted two, much larger population groups as good candidates for Risperdal treatment: elderly patients in nursing homes (often suffering from dementia or Altzheimers) and children (for “behavior problems,” often labeled as ADD, Autism or Asperger’s).¹

Of course, placing a powerful, anti-psychotic drug into these populations carried certain risks of known and dangerous side effects. For example:

1. A greater risk of an earlier death in elderly patients.²
2. A greater risk of gynecomastia (enlarged breast tissue) in boys.³

As of August 2012, Risperdal’s maker, Janssen Pharmaceuticals, and its parent company, Johnson and Johnson, had about 420 suits against them for injuries caused by Risperdal. About 130 of those lawsuits are by men and parents of boys who say Risperdal made them grow breasts.⁴

Lawyers for plaintiffs in cases against Risperdal say Janssen intentionally marketed Risperdal for off-label uses for children, despite the fact that the FDA didn’t approve the drug for those uses. Boys and girls as young as four years old have experienced growth of breast tissue and even lactation (the production of breast milk). The only treatment to remove the breast tissue in males is a mastectomy.⁵

In spite of these risks, the drug reps persisted in pushing the off-label sales, by any and all means they could think of.

According to the DOJ complaint, between 1999 and 2004, Johnson & Johnson paid $50 million in kickbacks to a pharmaceutical supply company, Omnicare, to sell Risperdal to nursing homes. The kickbacks appeared as payments to Omnicare for sham services, and Omnicare used the money to initiate programs aimed at convincing doctors to prescribe Risperdal to nursing home residents.⁶

Similarly, a whistleblower and former sales manager for Johnson & Johnson testified that his former employer increased sales of Risperdal to pediatricians not just by paying doctors to speak about the drug and paying for their golf trips, but also by providing bags of “Risperdal Popcorn.”⁷

The promotion ends when the patent runs out

Thankfully for the children and the grandparents, Risperdal is now off-patent, and so it is not likely that the drug reps will be promoting that one any more.⁸

Which leads to an interesting question.

What drugs are they pushing (off-label) to your doctor today?

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Sources:

¹ Complaint, United States v. Johnson & Johnson, http://www.justice.gov/usao/ma/news/2010/January/JJ/J&J%20complaint%20–%20filed.pdf
² Bloomberg, Fisk MC et al, “J&J Pushed Risperdal for Elderly after U.S. Warning, Files Show,” (10 March 2010) http://www.bloomberg.com/apps/news?pid=newsarchive&sid=ag4Ya8UOIob0
³ Cbsnews.com, Edwards J.,“Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids” (3 August 2011), http://www.cbsnews.com/8301-505123_162-42849344/claim-jj-wrongly-marketed-antipsychotic-drug-risperdal-to-kids/?tag=mncol;lst;4; CBS News, http://www.cbsnews.com/video/watch/?id=5038367n%3fsource=search_video
⁴ Bloomberg.com, Feeley J and Fisk MC, “J&J Settles Risperdal Lawsuit on Opening Day of Trial,” (10 September 2012), http://www.bloomberg.com/news/2012-09-10/j-j-settles-risperdal-lawsuit-on-opening-day-of-trial.html
⁵ Cbsnews.com, Edwards J.,“Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids” (3 August 2011), http://www.cbsnews.com/8301-505123_162-42849344/claim-jj-wrongly-marketed-antipsychotic-drug-risperdal-to-kids/?tag=mncol;lst;4; CBS News, http://www.cbsnews.com/video/watch/?id=5038367n%3fsource=search_video
⁶ Complaint, United States v. Johnson & Johnson, http://www.justice.gov/usao/ma/news/2010/January/JJ/J&J%20complaint%20–%20filed.pdf
⁷ “’Risperdal Popcorn’ – part of Day 2 of Philly trial,” Philadelphia Enquirer philly.com, Sept. 26, 2012, http://www.philly.com/philly/blogs/phillypharma/Risperdal-Popcorn-part-of-day-2-of-Philly-trial.html
⁸ “J&J Settles Risperdal Lawsuit on Opening Day of Trial,” Bloomberg News, September 10, 2012, http://www.bloomberg.com/news/2012-09-10/j-j-settles-risperdal-lawsuit-on-opening-day-of-trial.html