HealthFirst

HealthFirst-Off-label prescriptions

Monday, August 17, 2009

Tags:

healthfirst, leslie toldo

Leslie Toldo
More: Bio, E-mail, News Team

UNDATED (WJRT) -- (08/17/09) -- Nearly 25 percent of prescriptions are written for conditions that the drugs are not even approved for.

It's called prescribing off label, and HealthFirst reporter Leslie Toldo helps us weigh the benefits and the risks.

Medicare recently expanded its coverage of drugs used off-label to treat cancer, and the FDA made it easier for drug companies to market drugs for off-label use.

The choice is your doctor's, but should you take it into your own hands?

null: Follow us on Twitter

When attorney Allison Keller learned she had multiple sclerosis a year ago, she armed herself for the battle ahead. "I read the New England Journal of Medicine, obviously highly-respected, and read that it basically had a 70 percent better rate than the top medicine out there."

"It" was a cancer drug being used to treat her disease. Allison sought the treatment from her doctor, even though she didn't qualify for the trial.

"It kind of struck us that if we want this, we're going to have to take some risks," she said.

"Now, we're taking a drug that's a little bit more dangerous, potentially, and we're using it off-label," admitted Dr. Daniel Kantor.

Dr. Kantor is one of a growing number prescribing drugs for conditions the drugs aren't FDA-approved to treat. "We're allowed to do that as physicians," he said.

Drugs are often prescribed off-label for children and pregnant women because they're routinely excluded from trials. One recent study found the most common meds prescribed unsafely or ineffectively off-label were anti-depressants and anti-psychotics.

To keep yourself safe, ask your doctor if the benefits outweigh the risks and whether your insurance will cover it. Some doctors are prescribing a cocktail of off-label drugs called prometa to treat alcohol and drug addictions.

Critics like Dr. John Mendelson say there's no sound scientific support for this practice. "There have only been a few published reports describing prometa at all, and these reports are not what are called double-blind or placebo-controlled reports."

Former addict Matt McLellan says it's helped him stay sober for a year. "I think I'm just so blessed to have found a cure for this disease."

Some insurance companies deny coverage of off-label treatments, but in some states, insurers are required to cover them for cancer or other life-threatening conditions.

BACKGROUND: Off-label prescribing happens when physicians prescribe drugs for conditions or diseases the drugs aren't FDA-approved to treat. Off-label use includes guideline-recommended cases like aspirin to prevent cardiovascular disease in diabetes patients as well as last-resort therapy for autoimmune disease and transplantation. Sometimes, off-label use is unavoidable, such as in the treatment of children. Three-quarters of marketed prescription drugs carry no labeling indications for children since they have only recently begun to be included in clinical trials. Pregnant women are also often prescribed drugs off-label because they are routinely excluded from studies (Source: PLoS Medicine).

IS IT LEGAL? Although it's legal to prescribe drugs off-label, it's illegal for drug manufacturers to promote off-label use. Two physician researchers recently exposed some "covert" techniques drug companies were using to carry out this illegal practice in a PLoS Medicine study. Those techniques included seeking approval for new drugs for narrow indications even if the drug's makers believe there will be extensive off-label use. These indications act like decoys to avoid the costs and delay that long-term trials involve. Drugs for rare conditions like rabies are eligible for speedier trials and enter the market faster. Another technique is having drug representatives promote off-label uses to doctors, which is an illegal practice. Drug companies also push for off-label use through nationally-known academic physicians who use "word-of-mouth" or "buzz" marketing.

IS IT SAFE? In a recent study published in the New England Journal of Medicine, a panel of experts looked into the use of 14 drugs they considered to be used unsafely off-label. They found the antipsychotic drug Seroquel topped the list. The drug led all others in a high rate of off-label use with limited evidence. Seroquel is also marketed at a cost of $207 per prescription. The groups of drugs most common on the list of those prescribed unsafely off-label were antidepressants and antipsychotics. Most often, the drugs were prescribed off-label to treat bipolar disorder. "A dialogue needs to occur more frequently between physicians and patients regarding the level of evidence that supports a particular use of a drug," lead study author Randall Stafford, M.D., Ph.D., an associate professor of medicine at the Stanford Prevention Research Center, was quoted as saying.

MORE INFORMATION:http://www.neurologique.org