Public comment to the FDA, concerning its 2014-2018 strategic priorities

As you may know, I am quite passionate about the role of effective regulation in helping everyday people - who do not necessarily have the time, energy, or interest - live physically and mentally healthy lives.

Though I am not big on big government, I think regulations are necessary to keep large corporations from misusing and exploiting us more completely than they already are. If there were no corporations, I would be quite content with a much smaller government, because the wolves among us would not be cheered on by their underlings and stockholders ('The Wolf of Wall Street' comes to mind, far too vividly for my tastes).

But, there are corporations, unfortunately, and they do not give a damn about us. Let's be real, here, bodies being buried by the bottom line is nothing new. The Vioxx fiasco, in which 60,000 people died unnecessarily, is just one instance among many. Therefore, let's make ourselves heard and comment it up!

Though you need not take my own comment as a pattern by any means, I do want to share it for two reasons. First, to share some of my own concerns with you; and, second, to show you how much ground you can cover, albeit briefly, in your comment. You also have the option to attach additional documents, and that may be useful for academics who would like to include reference lists and the like.

Thank you for reading, and enjoy the following!

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To: Dr. Margaret A. Hamburg, Commissioner of the FDA.

I am a concerned citizen who would like to see the FDA continue to productively fulfill its mandate to regulate food and drugs on behalf of the general public. As I see it, areas in which the FDA can positively impact the public health in 2014-2018, and thereafter, include the following:

*Improve testing and labeling procedures of pharmaceuticals. With drugs like Vioxx, which killed over 60,000 people, FDA testing procedures failed to ensure safety. Reforms since then notwithstanding, the best way to ensure that trials are not biased is to change the way drug trials are funded.

*Fund drug testing trials differently. Allowing companies whose drugs are being tested to compensate the FDA directly for the cost of these trials carries the risk of bias. This is simply human nature. Funding by a common pool of moneys paid into by all pharmaceuticals, to be used when they are ready to bring a new drug to market, is a possible option. Another would be shifting the burden to taxpayers. The latter may be politically difficult, but would provide greater objectivity in testing.

*Prohibit off-label uses of pharmaceuticals, and require separate tests for each usage included on the label. There are a variety of drugs widely prescribed for off-label uses without adequate testing, such as the use of Seroquel to aid in falling asleep. The only responsible courses of action are prohibiting all off-label uses in marketing and prescriptions; making companies who market drugs for off-label uses and doctors who prescribe drugs for off-label uses accountable with large fines; and, allowing these uses to be added to the label only after appropriate testing, specific to each use, with the population intended to be targeted by that use.

*Review claims made for the efficacy, safety, and non-addictiveness of antidepressant drugs. The dangers of serotonin syndrome due to mixing antidepressants, and weaning effects when getting off them, are insufficiently known. The usage of antidepressants by perpetrators of various shootings in this country also deserves serious investigation, and labeling to the effect that even properly prescribed use of such drugs has been correlated in practice with violent behavior in a very small minority of cases.

     Long-term changes in neurotransmitter production that make life without depressants harder than it was before them is also possible, at least in some cases. This is not, I think, a comparison effect (life after being worse by comparison with life on them), but an absolute decrease in quality of life. David Foster Wallace's death while weaning from Nardil, after decades on this drug, may be cautiously advanced as a possible example. The withdrawal of the brain from a medication, as long as these effects are not due to the placebo effect or psychosomatic symptoms of other sorts, is physical withdrawal (the brain is part of the body, after all), whether it is felt in the limbs and torso or not.

     Warn patients and physicians more explicitly about serotonin syndrome due to antidepressant use, antidepressant dependency, and antidepressant discontinuation syndrome (also known as weaning effects).

*Discourage testing and marketing of pharmaceutical, high side-effect, high-cost drugs for conditions that can be as effectively treated by low-cost, high-safety treatments like exercise and proper nutrition, or medical procedures that primarily or solely make use of the placebo effect (acupuncture, homeopathic medicine, etc.).

     Prescribing exercise, for instance, should be preferred to prescribing Prozac. Exercise has benefits in all of life (rather than mental health alone), fewer side-effects, and a generally much lower financial cost. The cost-benefit profile of prescribing exercise for depression is likely superior to that of prescribing antidepressants in most patients. Advertisements for antidepressants should be required to direct consumer attention to non-pharmaceutical alternative treatments that have shown comparable efficacy.

     The Hippocratic Oath, 'Do no harm,' should be applied to our use of treatments for conditions of all types, including those treatments regulated by the FDA. If a treatment may be harmful, its use should be encouraged only if less harmful treatments have not brought relief.

Thank you for your time and consideration.

Sincerely,

C.Z. Wilson

Also consider the following steps:

*Require warnings on products containing unfermented soy or its derivatives, due to its endocrine-disrupting effects.

*Prohibit packaging materials, ingredients, and preservatives with endocrine-disrupting and neurotoxic properties, particularly in fragrances, body care products, plastics, and vaccines.

*Investigate the health effects of trace amounts of pharmaceuticals in the water supply.

*Conduct a double-blind test on the effects of water fluoridation, over the course of 5 years, in a study with over 1000 participants.