One pill makes you smaller… #SFRTG #IARTG #Kindle

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One pill makes you larger, and one pill makes you small
And the ones that mother gives you, don’t do anything at all

Grace Slick of the Jefferson Airplane

This is some of the research that contributed to the recently released Darwin’s Paradox: An international science mysteryhttp://amzn.to/2k8qJgi. “Doctor” Brian is in Mozambique and has been given pills to test for activity against a new disease. This raises all of the ethical issues associated with off-label drug use.

Grace Slick might have been singing about prescription drugs [I was there and I’m not talking]. If so, those pills would have been used off label. Off label is when a legal drug is used for something other than its FDA-approved indication. For example, drugs approved for bipolar disease or schizophrenia are often prescribed for depression, and blood thinners are prescribed for hypertensive and coronary heart disease.

This is legal. The FDA does not regulate the practice of the medicine, only the drug companies. For example, over three-quarters of children discharged from a hospital receive at least one off-label prescription.

What do you think about your doctor prescribing medications for you that have not been fully tested for safety or efficacy? What do you think about your doctor enrolling you, often without your knowledge, in an ad hoc science experiment?

Drugs are used off-label for many reasons. If a drug is generic, no one is motivated to spend the time and money to run the clinical trials required to get an indication approved, regardless of how safe and effective it is, or isn’t. Even if a drug is not generic, the approval process might not be deemed cost effective. Ironically, the larger the off-label market, the less a drug company would be motivated to fund a clinical trial. They (and the patients) are already benefiting from the sales, so why bother with the testing?

This is the conflict. If the doctors prescribe and the drug companies sell — all without clinical trials — who is protecting you? For example, estrogen medications were prescribed extensively to menopausal women to prevent coronary disease. It wasn’t until a government-sponsored trial found them to increase, not decrease, the risk of stroke and heart attack that this was curtailed.

You can think of each off-label prescription as a tiny clinical trial, without informed consent, without controls, without records, and without oversight. What do you think about being a test subject knowing that there is little chance that the result of your sacrifice and risk will add to scientific knowledge or benefit those who come after you?

Some might tell you the system is even more sinister. It turns out that drugs for rare diseases can be declared as orphan products. In this case the FDA streamlines (cuts corners) the approval process. This is good for those rare diseases, but once the drug is approved, it can be used off-label for whatever the doctors decide. This can be a cost-saving way for drug companies to get to market. For this reason, among others, drug companies are forbidden from promoting off-label uses. Regardless, drug companies have been penalized billions of dollars for violating the rules.

Who is protecting your well being? How can this system work at all?

This anxiety ignores one important fact of life. The fact of your unique DNA. People are different, and EVERY prescription (FDA approved or off label) is a science experiment. People respond individually to drugs. Side effects differ from patient to patient, ranging from benign headaches or muscle cramps to life-threatening reactions. Even popular over-the-counter (OTC) drugs like Tylenol(R) pose risks.

Doctors are the ones who read all that fine print and journals articles to be prepared and watchful for negative reactions from ALL prescriptions whether for FDA-approved or off-label.

In summary, around a billion off-label prescriptions are written each year with the overwhelming majority benefiting the patient. Like ALL medicine, there are benefits and risks, and doctors are the ones who balance them. Without doctors writing off-label prescriptions, millions would be suffering needlessly. It is the doctors who contribute the judgment that the bureaucracy can not.

So as Grace Slick recommended, “Go ask Alice,” especially if she is a doctor.

I am not an MD and am not giving medical advice.

For more information: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/

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Categories: Pharmaceutical Industry | Tags: , , , | Leave a comment

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