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The Old Bait and Switch: Frequent Off-Label Use of Subsys Prompts Investigation

Posted on 05/15/2014Back

To save money and boost profits, some drug and medical device companies have found it advantageous to seek FDA approval for one use of a product and go on to promote other “off label” uses for it after it is approved.

Aside from any ethical questions, there is one main problem with this marketing technique: it is illegal.

Photo borrowed from bad-drug.net

Unfortunately, that hasn’t stopped it from happening. We’ve told the story over and over again with Medtronic’s Infuse BMP, a spinal fusion product that was approved for a very limited use but was subsequently used off-label over 85% of the time. Medtronic paid doctors hefty sums of money to ghost write medical journal articles and promote the off-label uses, undermining the integrity of the peer review process and misleading hundreds of doctors about the safety of the product.

We are now seeing a similar story unfold involving Subsys, a narcotic that was approved in 2012 for use in cancer patients. The drug, manufactured by Insys Therapeutics, is a form of fentanyl – a narcotic that is often used when painkillers like morphine fail to provide relief. Insys Therapeutics has seen its share prices jump nearly 270 percent in the past year, largely due to the overwhelming popularity of this drug.

The FDA warned that the drug should only be prescribed by oncologists and pain specialists who treat cancer patients and only to cancer patients who were already using round-the-clock painkillers. According to former Insys employees, however, the company focused on frequent prescribers of competing drugs like Antiq and Fentora, regardless of whether those doctors treated cancer patients. According to data provided by Symphony Health, only one percent of prescriptions have been written by oncologists and approximately half by pain specialists. The other half of prescriptions were written by a wide range of doctors, including general practice physicians, neurologists and even dentists and podiatrists.

Fentanyl, like other opiates, carries a high risk of dependency. It can also cause respiratory distress and/or death if it is taken by people who are not regularly using painkillers already. Dr. Lewis S. Nelson, a medical toxicologist at the New York University School of Medicine, points out that while the drugs may be appropriate for a terminally ill cancer patient, they are relatively incompatible with a functional life.

The dependency factor works in Insys’s favor since patients will eventually need higher (and thus more expensive) doses of the drug. According to the New York Times, interviews with former sales representatives revealed that the company offered incentives to their sales force for selling higher doses of the drug. The representatives relied heavily on these incentives, as they were paid low base salaries, approximately half that of the industry standard.

Wall Street analysts seemed to pick up on this strategy, noting, “As Subsys grows more mature, we expect the number of experienced patients to grow… as experienced patients titrate higher, the average dose per prescription should increase.”

In December, Insys disclosed that it was under investigation by the federal health department’s Office of the Inspector General for its sales and marketing practices. Shortly thereafter, it announced plans to seek approval to market the product for a broader range of uses.

While it is acceptable for a doctor to prescribe a drug for off-label purposes as they see fit, it is illegal for a drug manufacturer to promote off-label uses. However, manufacturers have become very crafty in the way they influence doctors’ decisions, and by the time their tactics are noticed they have already made millions.

This will only get worse unless manufacturers are held accountable for their actions. GoldenbergLaw has 29 years of experience holding manufacturers of pharmaceutical drugs and medical devices accountable for their negligent actions. If you or a loved one has been harmed by the off-label use of a product, contact us.

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