Category Archives: FDA

The FDA Listens to Fibromyalgia Patients

On March 26th, 2014, after yet another snow storm, the FDA held a public hearing for patients, their advocates, and others with interest in the treatment of fibromyalgia. For four hours the doctors who work in the Division of Anesthesia, Analgesia and Addiction Products. They were attentive and asked pointed questions. The discussion focused on the multitude of symptoms patients experience, how well (or not well) medications have helped patients, the non-drug treatment options (including holistic and alternative treatments), the side effects and withdrawal symptoms of medications, and what an ideal medication would look like.

Attendees came from all over the country and even from other countries, like Mexico. Patients opened up their souls to the FDA panel, hoping that our desperation for treatments that actually help will be developed. I heard such heartbreaking stories. We all appear to be in the same boat – even though we can manage our symptoms to a certain degree, it does not mean we are living at a higher quality of life. We are treading water and getting nowhere. Fibromyalgia patients have to change their entire lifestyle in order to cope with the limitations of this illness, and that does not even include all the co-morbid conditions we have. The only people I know who do not have another chronic illness with fibromyalgia are those that doctors simply have not diagnosed yet. Fibromyalgia is an opportunistic illness.

In a few months (after additional comments have been submitted), the FDA will release its report on fibromyalgia based on everyone’s comments and concerns. I have high hopes for this document. It can help doctors understand the illness better. It can help pharmaceutical firms fine tune their research. It can help university researchers conducting their smaller research. It can help medical students learn about this illness. It can help politicians understand the illness so they can pass effective bills. It has the potential to improve the status quo like nothing before it.

Access to Pain Medications

On January 25th, 2013, the FDA’s Drug Safety and Risk Management Advisory Committee voted to recommend that the agency move the pain medication hydrocodone from Schedule III to Schedule II. The FDA usually accepts the recommendations committees like this one makes. This change is intended to hinder access to a medication that has a high incidence of abuse and addiction. What could possibly be wrong with more control over a substance that contributes to thousands of deaths and rehab visits per year? However, this seemingly innocent decision does not take into consideration several key issues.

First, millions of Americans take prescription pain medications every year. The majority of them DO NOT abuse these medications. They take them to manage their acute and/or chronic pain. We should not lose sight of this distinction. Why should they be penalized because a few abuse them?

Second, medications on Schedule II are not allowed to have refills. Patients can only get a one-month prescription at a time with up to three separate scripts allowed to be written per visit to the doctor. Patients will need to see their doctors more frequently, which can have financial consequences. Medicare and Medicaid patients are less likely to be able to afford more visits to their doctors, and may even have less access to covered doctors.

Third, medications on Schedule II can only be prescribed by physicians (and dentists, as long as it is related to dental care). Sounds like a good idea, right? But what if the patient lives in a rural area or inner city where there is a shortage of doctors? What if the patient only has access to a Nurse Practitioner? Each state makes their own rules regarding if Nurse Practitioners can write prescriptions for controlled substances. I know that in my area of New Jersey, there was only one pain management doctor accepting Medicaid patients as of a few months ago. One pain specialist for thousands of Medicare patients. Really? What is wrong with this picture?

In my opinion, more states should create and maintain a database containing information on who is receiving medications and how frequently they are filled. This will enable doctors and pharmacies to red flag patients who go from doctor to doctor getting multiple prescriptions for the same medication, who fill their prescriptions too early without a legitimate reason (going on vacation and need refill sooner; lost script). These databases should also allow access across states so addicts and abusers do not simply cross state lines to avoid detection. I know many states are doing this – my home state of New Jersey started one last year. Access to the databases should be limited in order to satisfy HIPPA regulations. For instance, all users must be registered by the state and can only access the information for approved reasons – or face legal ramifications.

Is this the cure-all for abuse and addiction to prescription medications in our country? Hell, no! But we must start somewhere and limiting access to pain medication to patients in pain is not the answer.