Are Off Label Drug Claims Offside?

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Have you heard the term “off label use” in passing, or in the news or from a friend? It refers to medications your doctor may be prescribing to you that have not necessarily been studied for that particular condition or disease.

The manufacturers of the medicines, and their agents argue that the ability to make off label claims is a benefit to the end consumer as costs are reduced. But the flipside is that it can be dangerous for the consumer who becomes the guinea pig, and some argue, simply because it’s profitable for the producers.

As well, the dollars you think you’re saving can vanish as health insurers often wriggle out of covering off label prescriptions.

Many times this off label feud has ended up in federal court, with hundreds of millions of dollars in fines being levied against the accused – and paid.

It’s a very serious topic that likely affects you or a loved one. Let’s zoom in on this and see what lies beneath the surface…

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Off label drug use more specifically means “the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, unapproved dosage, or unapproved form of administration.”

The FDA approves a drug for prescription use, but they do not have the authority to regulate the practice of the medicine, so a doctor can prescribe a drug for other reasons than that which it was approved for. Doctors using their best judgement in lieu of ‘perfect’ data is not a new phenomenon. It is a necessity referred to as ‘evidence based’ medicine. Not the most accurate way it could be described, as advice and prescriptions are given based on experience and hunches – specifically because sufficient clinical evidence is lacking!

In 1938 the FDA was given authority to regulate promotion by pharmaceutical companies. Since then a careful balancing act has carried on between giving doctors the freedom to use their best clinical “evidence- based” judgment when necessary, and preventing drug manufacturers from inappropriately influencing the prescribers.

Today it is illegal for the drug makers to promote off-label uses to physicians without formal government approval. However, the threat of the law has obviously been far from effective deterrent as seen by the fines that are given to the biggest of the companies year after year.

And that is why any consumers of medications are wise to add their own layer of screening.

Are You Using Off Label Drugs?

If you suffer from migraines, or depression, your doctor could prescribe an anti seizure drug.
Alzheimer’s Disease, autism, dementia, Attention Deficit Hyperactivity Disorder (ADHD)?
Your doctor is allowed to prescribe Antipsychotics (for Schizophrenia).
Chronic pain, ADHD, bipolar disorder? Many doctors can and will give you antidepressant drugs.

This is far from a comprehensive list but enough to get the picture that off label drugs should be concerning.

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Off Label the Good

There are some benefits and justifications to off label drug use. A primary one is the reduced cost for the end consumer. Because for a drug to be approved for extra off label uses it must go through lengthy and expensive studies and patent application processes. These enormous costs are passed on and paid for by the consumer at the check out counter.

Conversely, when the drug patent is over, a pharmaceutical company has no interest to pursue any label extension. That’s because they won’t be able to make back the investment without patent protection. So doctors will prescribe such a drug off label (when there is some evidence of efficacy and safety) as it may be the only possible treatment option.

As well, high-level evidence of safety and efficacy may be difficult to achieve for rare diseases, which do not lend themselves to large clinical studies. This puts doctors into a gray zone of prescribing off label simply due to having no better alternative.

Off Label the Bad

Professor Rebecca Dresser and Joel Frader, MD, wrote in the 2009 issue of The Journal of Law, Medicine & Ethics “Off-label prescribing can expose patients to risky and ineffective treatments”.

You cannot count on the law to protect you because, as Dresser continues “penalties…to this point have been dwarfed by the financial gains to pharmaceutical companies from engaging in improper off-label marketing.”

And that’s the crux of the problem – the profits the big pharmaceutical giants like Pfizer and Lilly make from off label use far outweigh the penalties they get for doing so. The fines are simply the cost of doing business.

Here’s a few head spinning and famous cases that show the magnitude of the issue:

  • Johnson and Johnson in 2013 was hit with a $2.2 Billion Settlement that headlines predicted is an amount that “Won’t Stop Big Pharma’s Addiction To Off-Label Sales”.
  • in 2007, to settle various civil allegations including its promotion of the antipsychotic drug Abilify, Bristol-Myers Squibb paid out $515 million.
  • GlaxoSmithKline plead guilty to off label criminal charges and paid out $3 billion to settle various government claims.
  • in part for its off-label marketing of Zyprexa, Eli Lilly paid $1.415 billion in fines.

According to estimates, off-label prescriptions make up 20 percent of all prescriptions, equalling $40 billion in sales annually. Though it’s acknowledged that doctors typically are under educated in medical school about off label prescribing, an (unknown) proportion is beneficial for end consumers.

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Questions to ask Your Doctor

Despite what some authorities might say, it is your right to know what you are putting in your body, and how much safety and efficacy data there is on what you are paying for.

Though it’s hard to believe, doctors aren’t required to disclose off-label drug use to patients. Some doctors say that doing so would be “impractical”. So whenever you are given a prescription you might want to ask your doctor the following questions: Is the medication off-label? What is the evidence/studies behind your prescribing this to me?
How certain are you that I will benefit from this medication?

These questions are a small start in taking your health matters into your own hands.


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Michael Dewey

About Michael Dewey

Mike is AlgaeCal’s Editor in Chief, and was born in Toronto, Ontario. He is responsible for most of AlgaeCal’s writing material such as blog posts, and you might recognize his face from the AlgaeCal newsletters as well. Outside of work, Mike pursues both sporting and creative pursuits. He enjoys beach volleyball, cycling hockey, baseball and snowboarding, but also uses digital technology to compose his own music; merging and stacking layers of instruments and vocals, one-by-one, to make a full band sound.