Too Many Docs Prescribe Drugs Off-Label Too Often

Although drug companies are not allowed to promote or market their products for any use other than those approved by the FDA, doctors may prescribe drugs to some patients to treat conditions other than those included in FDA approval. It’s called “off-label” use, and can result in good outcomes.

But Dr. Allen Frances believes that too many doctors are prescribing too many drugs off-label, as he explained on, and the practice can be risky.

Allen, a psychiatrist, believes many patients are getting medicine they don’t need because doctors don’t resist the pressure to prescribe them applied not only by “intense drug company marketing,” but from patients “who aren’t happy leaving the office without a pill.”

Another reason doctors prescribe instead of communicating, Frances said, is because they don’t have enough time to spend with each patient. We’ve heard this story before – good medicine isn’t an assembly line, and people’s problems don’t always fit neatly into sets of symptoms with matching diagnoses and treatments. It takes time to tease out all the factors contributing to why you don’t feel well.

But Frances believes the time crunch isn’t just a result of diminishing pay and increasing paperwork. “Wild prescribing is not new,” he wrote “For thousands of years, doctors have given patients useless (and often quite harmful) drugs and patients have taken them.”

Frances’ commentary relied heavily on the experiences of Kim Witczak, who became a drug safety advocate after her husband died from a drug side effect that had not been disclosed to him. A lot of what he has to say comes from her website, WoodyMatters, named for her husband. Its purpose is to raise consciousness about drugs, and the practice of off-label prescribing.

As many as 1 in 5 of all drugs are prescribed off-label, and among psychotropic drugs, or those that treat mental disorders, its use approaches 1 in 3 prescriptions. Frances pointed out that as medicine evolved, it was supposed to rely on scientific evidence to separate real effects from the placebo effect. (The placebo effect is when improvement occurs in response to treatment that can’t be attributed to the properties of the placebo, a fake pill or device, so it must be the result of the patient’s belief in the treatment.)

“[E]vidence-based medicine is only as good as the evidence it is based on,” he wrote. “And in many instances our evidence is not very good because it comes from biased drug company studies.”

He said this is so especially for the off-label prescription of medicines, which he called “the wild west of medicine – any doctor can prescribe any drug for any problem.”

Frances’ report referred to a recent study indicating that 1 in 3 children in foster care diagnosed with attention deficient hyperactivity disorder (ADHD) are treated off-label with an atypical antipsychotic medication. (See our blog, “Boom in ADHD Diagnoses Can Lead to Overmedicating and Drug Abuse.”)

He quotes liberally from Witczak. “As a parent, would you consent to your child being prescribed an antipsychotic medication? The name alone should raise a red flag. And most atypical antipsychotics are NOT approved by the FDA for use by children.” (See our blog, “Too Many Docs Don’t Follow Antipsychotic Prescribing Guidelines for Kids.”)

Eight in 10 drugs used off-label lack “strong scientific evidence,” which means that it’s not clear that their benefits outweigh their risks.

“It’s one thing if you have a rare disease and are desperate to try something that might offer hope,” Frances/Witczak acknowledged. “It’s another thing if you went to your doctor because you’re having trouble sleeping due to stress of a new job. … We need to be told if the FDA has approved the product or if it’s being used off-label based on an article that appeared in some journal. Otherwise, we are just guinea pigs.”

That’s reasonable – if your doctor prescribes a drug off-label, he or she is obliged to tell you. But as a partner in your health care, when your doctor prescribes medicine for the first time, ask these questions:

  • Why is this the best treatment?
  • What will happen if I don’t take it?
  • When can I expect to see results?
  • What are the side effects, and how likely am I to experience them?
  • What are the risks?
  • Are there foods or other medicines I should avoid when taking this medicine?

The FDA enables knee-jerk off-label prescribing behavior, and the agency is considering revising what it disseminates from medical and scientific journal publications. Its draft guidance of “Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices” allows the drug industry to distribute journal articles and clinical practice guidelines (CPGs) regarding off-label use of their products to the medical community.

“This is basically a loophole for the pharmaceutical companies to promote their products off-label,” Frances/Witczak said.

We often report on the huge fines drug companies pay to settle lawsuits related to fraudulent marketing practices, including off-label promotion of their drugs/devices not approved by the FDA, and how these guilty parties see them as just the cost of doing business. Frances is concerned that the fine line between companies informing doctors about a new potential benefit in an off-label indication and the illegal promotion of a product to increase sales will become even thinner, and maybe just disappear.

Medical journal articles can be biased because their authors or ghostwriters sometimes are paid by the company whose product is being studied. Frances wondered, “Why not require doctors to get written informed consent from their patients for all use of medication? This would make for much better-informed consumers and reduce careless over prescription of medication.”

“Off-label prescribing is much better for drug company profits than for patient welfare,” he concluded, adding that doctors have no reason to assume such treatments will work, but every reason to know they will have side effects. “Prescribing for indicated uses is overdone, prescribing for off-label use is rarely justified.”

We’re not ready to support such a sweeping statement, but we certainly advise caution and agree that it’s easier to prescribe a drug than spend the time and do the hard work necessary to provide alternatives.

Learn about particularly dangerous drugs from our backgrounder.

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