Botox – Off Label use of Drugs by Physicians and the FDA

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Botox, Like Testosterone is a truly amazing drug that is mostly used off label to cure problems that don’t have a medical solution.

“The off-label use of Botox, like that of any FDA approved drug, is legal in the United States. That is because once a drug has been approved by the FDA for a condition, licensed physicians are legally allowed to prescribe it for any medical issue they think it could benefit regardless of whether it has been approved to work for that condition.”  (Time Magazine January 16, 2017).

In the United States medications cannot be prescribed by physicians unless they are approved by the FDA or are compounded by a pharmacist. In general there is a narrow range of illnesses that each drug is  approved for. Many doctors refuse to work outside the guidelines of the FDA so their patients suffer because they often can’t find answers to their diseases.  Those doctors who do use drugs off label open the options for their patients, but then insurance plans use the non-approved use as a reason to deny coverage.  This makes an effective drug out of the reach of many Americans.

In the example of Botox, there are several approved uses by the FDA, but half of symptoms and diseases that it does work for are not approved by the FDA.  In regard to Testosterone for women, no bio-identical non-oral pellet is approved for women, only men.  Testosterone can treat and cure many diseases and conditions that patients currently use a large group of prescriptions for without relief. Testosterone, like botox can cure or prevent many diseases of aging.  Testosterone  pellets for women prevent osteoporosis, dementia, diabetes, painful intercourse, lack of libido, anxiety, depression, obesity, frailty, symptoms of menopause, vaginal dryness, bladder incontinence, bladders spasm, migraine headaches, PMS and autoimmune diseases.  But Testosterone is not only not approved to treat these diseases, but is not paid for women for any reason!

Like Testosterone, Botox is not approved for use in treating depression, but it is becoming more commonly used for this disorder off label due to the communications between doctors and the makers of Botox. Doctors are reporting that it is successful and they are conducting their own research to try to obtain extended FDA approval. But in the meantime those patients who receive it are getting better because their doctors are willing to use if off label because they see that it works for depression.  The problem is that it is not paid for by insurance for depression.  

This story is not unusual for Botox, nor is it unusual for Testosterone. Because of these successful off label uses millions of people are being treated for conditions like migraine headaches, leaky bladders, premature ejaculation, and some cardiac conditions because doctors are willing to treat using off label treatments. This creativity  and bravery on the part of doctors allows the drug company that makes Botox to test new uses for Botox.  They can because they have a deep pocket to pay for the trials and they have a patent on Botox that limits others from using their investment of research.

The difference between Botox  and testosterone pellets for women is that there are NO indications for testosterone in women, and no drug company behind the production of T pellets for women.  Because it is a natural hormone, it is difficult and expensive to patent.  Several other forms of Testosterone have been rejected for approval for women because they caused facial hair…a non-life threatening condition, and self dispensed dosages of T can be missed or misused which cause side effects, or no- effect. Because of the money lost by pharmaceutical companies trying to get the T patch for women approved, it will be a long time before any other wealthy drug company begins to research and develop another T for women.

Comparing Testosterone pellets to the risks of Botox is like comparing drinking water to drinking gasoline, but Botox got through and so it should! Botox, is one of the most toxic substances known to man, but  can be safely used in small doses by doctors who know how to use it. It is used for a wide and increasing range of illnesses and conditions.  What is it about Testosterone, a naturally occurring hormone in women, that  strikes fear in the heart of the FDA?

Our reason for discussing it this week is that we feel that even though brave doctors use off label drugs , that there is a danger to the consuming public from the FDA and Big Pharma to reduce the capacity of compounding pharmacies to make bio-identical hormones like testosterone and in doctors to use these medicines off label to treat the conditions that the FDA wants to contend should not be treated this way.

We encourage you to read the article in Time and to contact your Congressman and your Doctor to get them to reduce the over regulation of these medicines. We think the over regulation is not in the interest of public safety but in the interest of financial control by Big Pharma of what doctors can do. The patient and the health of the patient are among the very last things being considered.

This past November, 2016 the FDA held a two day hearing asking for expert comment on the agency’s rules concerning off label drug use and marketing the response, as you would expect was mixed. Some claimed it was too restrictive and limiting and others claimed it needed to be tightened up or eliminated.

“Off label use is a topic the FDA has been eyeing for some time. There have been many instances where unapproved uses of a drug, even when commonly accepted by the medical community, have later been shown to be unsafe or ineffective or both—sometimes with devastating consequences to public health” says the FDA’s  representative.

It is amazing to watch the spread of usage for Botox through word of mouth. You may not know it, but drug companies can be charged very high fines for marketing drugs for off label use that have not been FDA approved. So the growth of the use of the product is almost entirely word of mouth from doctor to doctor and from patient to patient. This is an incredibly expensive and frustrating system that needs to be changed. The cost in money and suffering is considerably higher than it should be.

This Health cast was written and presented by Dr. Kathy Maupin, M.D., Bio-identical Hormone Replacement Expert and Author, with Brett Newcomb, MA., LPC., Family Counselor, Presenter and Author. www.BioBalanceHealth.com.