Dr. Kathy Maupin and Brett Newcomb discuss the role that the Food and Drug Administration plays in today’s medical arena. They talk about how faulty policies and business interests can often keep patients from receiving optimal and effective treatment.
This week, Brett Newcomb and I are revisiting the implications of the decisions made by the Federal Drug Administration, and medications that they regulate here in the United States. The FDA is a federal agency that has control over what drugs are legal for use by American citizens. Patients’ access to any given drug is dependent on a specific regulation process. First, the drug in question is approved for use to treat specific diseases, even though it may be highly effective for many diseases. The FDA can can prevent pharmaceutical companies from manufacturing and selling certain drugs in the US, even though these same drugs are sold and used in Europe. They also have the power to indefinitely delay the approval of the drug by demanding expensive and lengthy clinical trials. Some drugs will never be approved by the FDA (such as bio-identical hormones) because they are not patentable and therefore will not produce a profit high enough to justify the cost of the clinical trials. The FDA is controlled by politicians who can prevent a drug from being released based on their personal beliefs or expectations from their supporters.
With a limited diagnosis, a doctor is often unable to give a patient what they need. Doctors can still prescribe medicine for a disease not approved by the FDA, but that leaves them at risk for litigation. Doctors must stipulate this prescription in the consent form that patients sign. When a doctor uses a particular medicine for a purpose for which it was not FDA-approved, it is called “off-label usage.” Most doctors live in fear of being sued, so many doctors will limit their liability by just using drugs that are approved by the FDA for a particular disease, even if they know there is a cheaper or more effective drug that has not been approved.
Some doctors, however, will not ever use a drug for an off label reason. They are proud of that and claim it as a mark of excellent medical practice for themselves. I disagree with them. I think a physician should use their knowledge and training in pharmacology to find the best medicine for the symptom or problem, whether or not the FDA has approved it for that specific symptom. The doctor can ask the patient to sign a release accepting responsibility for the decision and informing them that the FDA does not approve the drug for this usage. They can inform the patient of their reasoning and experience in using the drug in this off-label way, and ask the patient if they want to take the risk and the legal responsibility. If the patient agrees, then the doctor is protected from the rigors of lawsuits.
The FDA also has the power to prevent medications from being manufactured and distributed in the United States. They can also prevent instruments and procedures—that are common practice in Europe or elsewhere—from being used in the U.S. Some medications are allowed to be sold in the US but the insurance industry has used non-approval of the drug as a reason not to pay for it. That makes it difficult for some patients to be able to afford a drug, thanks to the FDA’s operating procedure.
In this week’s podcast, we discuss an article written by Dr. John Hagan in a recent issue of Missouri Medicine, a journal for physicians and medical professionals published in Missouri. Dr. Hagan writes in support of Dr. Stephen Slade who had written the previous month. Dr. Slade writes from his standpoint in Opthamology about various drugs, instruments, and techniques that are legal and common in Europe but are not allowed in the United States because the FDA has not yet approved them. Many of these treatments have been utilized for years in Europe and have been extensively researched, but still cannot be used in the U.S. The machines, tools, and drugs are often made by American Companies, but still cannot be sold here. Dr. Slade says this is due to the lack of care and motivation on the part of the FDA. The outcome is that many American patients suffer blindness, discomfort, and even death because they cannot receive certain treatments. He wants that changed, but the FDA is a roadblock. Worse yet, the FDA is paid for by tax dollars, so who are they really serving?
Dr. Hagan supports the allegations of Dr. Slade, and so do we. The FDA is a regulatory agency with a revolving door policy for employment. Its scientists and employees come from the medical manufacturing, clinical research, and pharmaceutical companies and when they no longer work for the FDA making regulations, they go back into those worlds at higher rates of pay. Many of them promote the vested interests of these three industries without regard to the patients who need treatment. We believe that it is not just about public safety and good medicine, but money and power and political agendas. Listen to our podcast this week and see what you think.