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A very powerful new painkiller is taking over the market and has become a $100 million business. But, questions are lurking about how the drug is sold and to whom.

In 2012, a new narcotic called Subsys, was approved by the F.D.A for use by cancer patients. It is used when painkillers like morphine fail to provide relief. The intended use is for the cancer patients who are already using around the clock painkillers. The F.D.A. warned that it should only be prescribed by oncologists and pain specialists. However, according to data provided by Symphony Health, only about 1 percent of prescriptions for Subsys are written by oncologists.

Nearly half of the prescriptions for Subsys are written by pain specialists and the rest are written by a wide variety of doctors, including dentists, neurologists, podiatrists, and general practice physicians.

Marketing Against F.D.A’s Regulations

This may all be due in part to the company’s aggressive marketing strategy.  The powerful drug, Subsys, is from Insys Therapeutics in Chandler, AZ. According to several former Insys sales representatives, the company aggressively markets the drug to physicians who do not treat many cancer patients. They also pay the sales force higher commissions for selling higher doses of the drug.

The problem with this model of marketing is that under F.D.A. rules, manufacturers can market prescription drugs for approved uses only. However, doctors are allowed to prescribe drugs as they see fit.

It appears that part of Insys’s marketing strategy relies on the assumption that patients will eventually need more and more of the drug, as well as higher doses. The higher doses are more expensive than the lower doses and the sales reps are paid more for selling higher doses.

Subsys is sprayed under the tongue and takes effect quickly. This is wonderful for cancer patients who are in intense pain. This is bad news for other patients who aren’t already taking pain medicine. Respiratory distress and death can occur if taken by people who aren’t using painkillers regularly.

Settlements For Encouraging Doctors To Prescribe Drugs For Off-Label Uses

Throughout the last 10 years, billions of dollars in settlements have been paid by pharmaceutical companies to settle claims that they encouraged doctors to use drugs for off-label or nonapproved treatments just to increase profits and sales.

Drug-safety experts are troubled at the wide range of medical experts who are prescribing the drug Subsys. This is especially true given the widely known abuse of narcotic painkillers. Subsys is a highly addictive and powerful drug.  According to Dr. Sidney M. Wolfe of Public Citizen Health Research, ““You’re essentially spreading the accessibility to a very potent, rapid-onset narcotic to a large number of people, and a number of them may get addicted.”

 

Insys Is Being Investigated

The federal health department’s Office of the Inspector General has subpoenaed documents from Insys related to its sales and marketing practices. Insys says it is cooperating with the investigation.

Wall Street Rise and Fall

Insys shares had an explosive growth when Wall Street investors bet the company’s sales would rise. Now, investors are counting on the stock to decline. After a neurologist in Michigan was arrested on federal fraud charges, the stock for Insys declined by a third in just a week. The neurologist was a top prescriber of Subsys.

Subsys Is Not Compatible With Having A Functioning Life

According to Dr. Lewis S. Nelson, a medical toxicologist at the New York School of Medicine, “If you’re waiting to die, you should die in comfort and dignity. It’s very different than if you’re attempting to have a functional life, because these drugs are relatively incompatible with having a functional life.”

The Future for Subsys

Despite everything, sales for Subsys are growing rapidly. The company reported the first quarter of 2015 saw $40.7 million, while the first quarter of 2014 was at $9.7 million. Insys announced earlier this year that they intend to seek approval to market Subsys for a broader range of uses, including uses for children, for burn victims and for use in emergency rooms.