Prescribing off-label: It’s gotten out of control

Doctors prescribe way too many medicines for patients who don’t really need them. A lot of the pressure comes from intense drug company marketing. Some comes from patients who aren’t happy leaving the office without a pill. And doctors have too little time with each patient to explain non-pill solutions to problems. Wild prescribing is not new. For thousands of years, doctors have given patients useless (and often quite harmful) drugs and patients have taken them.

Modern medicine was meant to be different — it would be based on scientific evidence that could tease out real effect from placebo effect. Unfortunately, evidence-based medicine is only as good as the evidence it is based on. And in many instances our evidence is not very good because it comes from biased drug company studies.

This is particularly true for the “off-label” prescription of medicines — use based not on the systematic study required for an FDA indication. Off-label prescribing is the wild west of medicine — any doctor can prescribe any drug for any problem.

Kim Witczak became involved as an ardent drug safety advocate after the death of her husband, Tim “Woody” Witczak, in 2003 as a result of a drug side effect that had not been disclosed to him. She has taken her personal experience and launched a national drug safety campaign.

“Doctors routinely give powerful drugs off-label to their patients, without strong scientific evidence proving the drugs will be safe or effective, and sometimes despite warnings that such prescribing could cause serious harm.

All the while, patients have no idea that the drug that’s being recommended to them does NOT have FDA approval for the particular condition. They just assume and trust their doctor.

Once a drug has been approved for sale for one purpose, physicians are free to prescribe it for any other purpose. They are not limited to official, FDA-approved indications. Off-label prescription use is very common. Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31 percent.

A recent study reveals that one-third of children in foster care diagnosed with ADHD have been treated off-label with an atypical antipsychotic medication. 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.

Drugs are often used off-label, with nearly 80 percent of off-label prescriptions lacking “strong scientific evidence,” which means we do not know if their risks outweigh their benefits. Ultimately, it’s buyer beware.

It’s one thing if you have a rare disease and are desperate to try something that might offer hope. It’s another thing if you went to your doctor because you’re having trouble sleeping due to stress of a new job. Again, it’s a fine (yet potentially deadly) line patients are walking. 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.

The FDA may soon make matters worse. It is considering new policies on distributing reprints of medical and scientific journal publications. In its new draft guidance entitled, “Distributing Scientific and Medical Publications on Unapproved New Uses-Recommended Practices.” The drug industry will be allowed 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.

In recent years, over $13 billion in fines have been paid by major drug companies to settle lawsuits against them for their fraudulent marketing practices, including off-label promotion of their drugs/devices not approved by the FDA.

It’s a fine line between the drug company informing doctors about a new potential benefit in an off-label indication and the illegal promotion of a product for increasing sales.

In my opinion, this new guidance sends mixed messages. On the one hand, the FDA states that it “recognizes the value to health care professionals of truthful and non-misleading scientific or medical publications on unapproved new uses.”

But as everyone knows, medical journal articles are often biased because the authors or ghostwriters are paid by the company whose product is being studied. This should be very concerning to the doctors and patients alike.

Now more than ever, Informed consent is needed. It’s a great opportunity for patients and/or their caregivers to have an intentional conversation with their doctor about their medications. Armed with ALL the information, including if the drug is being used off-label, patients are then able to make an educated and informed decision about their drugs.

Sure seems like we could all get behind this concept and demand informed consent for drugs being given off-label. It just makes common sense for everyone, patients, and doctors, alike.”

Thanks, Kim. This is a great suggestion that I would extend even further. 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. Using medicines for unapproved uses on balance probably does much more harm than good. The doctor has no reason to think the medicine will work, every reason to know it will have side effects. Prescribing for indicated uses is overdone, prescribing for off-label use is rarely justified.

It would be a great mistake for the FDA to loosen its already weak control over drug company salesmanship. Drug companies have in past sustained large fines for illegal off-label marketing because the rewards are so great. FDA would be opening the gates to even more unscrupulous drug marketing. We need to restrict misleading marketing not promote it.

The argument that drug sales people are educating physicians doesn’t pass the laugh test. Their compensation is based on how much product they can move, not on appropriateness of prescription. And no study funded by a drug company can ever be trusted.

Allen Frances is a psychiatrist and professor emeritus, Duke University.  He blogs at the Huffington Post.

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