Dennis Miller, R.Ph. is a retired chain store pharmacist. His book, The Shocking Truth About Pharmacy: A Pharmacist Reveals All the Disturbing Secrets, can be downloaded in its entirety at Amazon for 99 cents.
Here is his essay on how the FDA should change to regain the public trust.
[1] Drug safety and effectiveness
FDA should explain why its definition of “safe and effective” is so vastly different from the layman’s definition. FDA does not explain how a drug that can cause death can be classified as “safe” and how a drug that is only a tiny bit more effective than a placebo can be classified as “effective.”
FDA should explain that its approval does not mean drugs are “risk-free” or “without risk.” Reading the adverse effects section in the official prescribing information illustrates to me that FDA clearly allows a level of risk from pharmaceuticals that is far greater than the public assumes.
[2] The placebo effect is very important
FDA should require drug companies to acknowledge that much of a drug’s effectiveness may be due to the placebo effect. FDA should acknowledge that many of the drugs it approves demonstrate only marginal benefit over a placebo. When drug side effects are factored in, the placebo might actually be the superior agent in some cases.
Why doesn’t FDA require drug companies to openly acknowledge the fact that the placebo effect accounts for much of the benefit that many people experience from many drugs? Why doesn’t FDA require drug companies to inform patients when a drug demonstrates only a limited advantage in comparison to a placebo?
[3] FDA should rate drugs like Consumer Reports rates household products and cars
FDA should classify drugs on a scale of effectiveness compared to other drugs, non-drug treatments and a placebo. We need FDA to evaluate drugs like Consumer Reports rates cars, appliances, personal computers, lawn mowers, etc.
[4] Extreme variability in safety and effectiveness among various classes of drugs
FDA should acknowledge the extreme variability in safety and effectiveness among different classes of drugs. I wish FDA would classify drugs as “highly effective” (for example, insulin, antibiotics, morphine for moderate to severe pain, naloxone for opioid overdose, epinephrine for reactions to things like peanuts or bee stings, antivirals for HIV and Hep-C, thyroid hormone for hypothyroidism, etc.) or “questionably effective” (for example, bisphosphonates and calcium supplements to prevent osteoporosis, the cough suppressant dextromethorphan, phenylephrine when used as an oral decongestant, muscle relaxants, as well as drugs for Alzheimer’s, depression, psychosis, etc.).
[5] Drugs for mental disorders are poorly understood and questionably effective
FDA should acknowledge that drugs affecting the brain are among the least effective and least understood drugs in the pharmacy. FDA should acknowledge that the human brain is immensely complex and that the explanations for a drug’s actions are very often just theoretical.
[6] Chemical imbalance theory
FDA should acknowledge that the “chemical imbalance theory” for mental problems has been largely discredited despite the fact that this theory has been the foundation upon which the prescribing of drugs for mental problems has been based for many decades.
[7] Diseases of modern civilization
FDA should acknowledge that most of the drugs that pharmacists dispense are to treat preventable diseases of modern civilization. So why is the focus of our medical system on treatment rather than prevention?
[8] DTC advertising of Rx drugs
FDA should ban direct-to-consumer advertising of prescription drugs because these ads significantly contribute to overmedication. These advertisements increase the use of the expensive advertised drugs even though there may be safer and less expensive alternatives available, including non-drug approaches.
[9] Carcinogenic drugs
FDA should explain the significance of tumors and cancers in lab animals exposed to commonly prescribed human drugs. FDA has a tremendous amount of data about drug carcinogenicity but doesn’t seem to know what to do with this data.
[10] Most cancers are preventable
FDA should acknowledge that most cancers are preventable. According to the The Merck Manual (17th edition, pp. 2591-2592), up to 90% of cancers are preventable:
Environmental or nutritional factors probably account for up to 90% of human cancers. These factors include smoking; diet; and exposure to sunlight, chemicals, and drugs. Genetic, viral, and radiation factors may cause the rest.
Given the fact that most cancers are preventable, why does our medical system focus on the treatment of cancer? Answer: There’s no money in prevention.
FDA should not normalize a society awash in synthetic chemicals.
[11] Cancer in the reproductive organs
FDA should acknowledge the serious implications of cancer in our reproductive organs (breast, uterus, cervix, and testes) that is partly a result of our exposure to synthetic chemicals that are ubiquitous in modern society. Should we be concerned about decreasing sperm counts and cancer in our reproductive organs as regards the propagation of our species?
[12] Clinical trials
FDA should acknowledge that the volunteers who participate in clinical trials are often not representative of the people who will take the drugs in the real world. Unlike the typical user of these drugs, volunteers in clinical trials are typically younger and healthier and take no other drugs.
[13] Adverse effects of drugs
FDA should acknowledge that no one knows the real-world incidence of side effects like muscle pain and weakness from statins and tendon damage from quinolone antibiotics.
FDA should acknowledge that it passes the buck to physicians as regards drug safety. FDA expects busy physicians to carefully read the official prescribing information to evaluate drug safety. But physicians assume that if a drug is still on the market, FDA basically considers it to be safe.
FDA should acknowledge that the addition of black box warnings to the official prescribing information (often years after approval) indicates that FDA doesn’t fully understand the safety of the drugs it approves.
FDA should admit that it may be wise to wait five years before taking a newly approved drug. Waiting for five years can allow adverse effects to emerge that were not discovered during clinical trials.
[14] Taking action against harmful and ineffective drugs
FDA should explain why it takes so long to take action against ineffective drugs. FDA should acknowledge that dextromethorphan is ineffective as a cough expectorant and phenylephrine is ineffective as an oral decongestant, despite both having been ingredients in cough and cold remedies for many decades.
In my opinion, the long delays in taking action against ineffective or harmful drugs are a consequence of Pharma’s influence over the FDA.
[15] Inadequate staff to inspect manufacturing facilities around the world
FDA should acknowledge that it has inadequate staff to assure the quality of generic drugs made in India, China, and other countries around the world.
[16] Regular release pills versus extended release pills
FDA should acknowledge that extended-release drugs are potentially more problematic (resulting in erratic blood levels and poor therapeutic response) in comparison to immediate release drugs. The manufacturing process for extended-release pills is more complicated than for regular-release pills.
[17] “Regulatory capture”
FDA should answer critics who say that the agency has been “captured” by Pharma. The FDA is clearly not the watchdog that the public expects and hopes. The FDA represents a clear example of “regulatory capture.” That’s a situation in which an industry that is supposed to be regulated by a governmental entity ends up controlling the regulator. The governmental entity (FDA) which is supposed to guarantee the safety and effectiveness of drugs has in reality been captured by the pharmaceutical industry.
[18] Playing games with statistics
FDA should prevent drug companies from playing so many games with statistics like the use of “relative risk reduction” rather than “absolute risk reduction” and the use of “surrogate endpoints” rather than “decreases in all-cause mortality.” FDA should publicize the importance of NNT (number needed to treat) to help consumers evaluate the effectiveness of drugs.
[19] “Me-too” or “copy-cat” drugs
The FDA should acknowledge that many of the drugs it approves are only “me-too” or “copy-cat” drugs despite being promoted by the drug industry as if they are as important as insulin and antibiotics.
[20] Pharma’s corrupting influence on academic research and medical journals
FDA should acknowledge Pharma’s influence over academic research and medical journals. Medical journals’ dependence on drug advertising revenue can mean that the results of poorly designed clinical trials are published without adequate scrutiny.
[21] Difficult withdrawal from many classes of drugs
FDA should acknowledge that withdrawal can be a big problem when trying to get off many classes of drugs such as antihistamines, proton pump inhibitors, nasal decongestants, narcotic analgesics, antidepressants, and benzodiazepines.
[22] USA ranks poorly on indices of population health
FDA should acknowledge that USA ranks poorly on many indices of population health. For example, according to a “List of countries by cancer rate,” on Wikipedia, USA is the fifth worst among 50 countries. The only countries with a higher cancer rate are Australia, New Zealand, Ireland, and Hungary.
[23] Specific medical conditions
–FDA should acknowledge that fever should not always be treated. Moderate fever can be a protective mechanism to fight infection.
–FDA should acknowledge that cholesterol is essential for the proper functioning of every cell in the human body. For example, cholesterol plays a major role in brain functioning. “The brain contains the highest level of cholesterol in the body; it contains approximately 20% of whole body cholesterol.”
Exp Neurobiol. 2019 Oct; 28(5): 554–567.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6844833/
In addition, search Google for “What percent of the brain is cholesterol?” or “Why is cholesterol abundant in the brain?”
–FDA should acknowledge that most cases of type 2 diabetes can be prevented with dietary and lifestyle changes.
–FDA should prevent Pharma from portraying stomach acid as an error in human evolution that must be counteracted with antacids, H2 blockers, and proton pump inhibitors.
–FDA should acknowledge how common and potentially dangerous “postural hypotension” is with blood pressure drugs. For example, you can fall and break a hip if your blood pressure has been lowered to an extent that you feel dizzy and lightheaded when getting out of the bed and heading to the bathroom to urinate in the middle of the night.
[24] Specific drugs
–FDA should acknowledge that despite decades of marketing by drug companies about the wonders of calcium supplements, these supplements are, at best, questionably effective in preventing osteoporosis.
–FDA should acknowledge that sunscreens are more effective in preventing sunburn than they are in preventing skin cancer.
–FDA should acknowledge the poor safety track record for weight loss drugs despite eternal optimism for a magic bullet against obesity. Don’t let the hype divert you from the potential adverse effects, some of which can be serious.
–FDA should acknowledge that nonprescription drugs can have serious adverse effects even though they are available without a prescription. For example, NSAIDs increase the risk of cardiovascular disease and GI bleeding.
–FDA should acknowledge that acetaminophen is the most common cause of acute liver failure in the USA.
–FDA should acknowledge that anticholinergic drugs may increase the risk of dementia.
–FDA should acknowledge that a poor diet plus vitamins is still a poor diet. FDA should acknowledge that it is better to satisfy one’s vitamin requirements from foods rather than from pills.
[25] Regulation of foods
Keep in mind that FDA stands for “Food and Drug Administration.” The foregoing discussion applies to the part of FDA that regulates drugs. The following applies to the part of the FDA that regulates foods. In my opinion,
–FDA should acknowledge that the fewer processed foods one eats, the better.
–FDA should acknowledge the potential risks of high fructose corn syrup, a sweetener that is extensively used in processed foods.
–FDA should acknowledge that gluten sensitivity is widespread, with potentially serious health effects until the condition is diagnosed and appropriate dietary changes are made.
–FDA should acknowledge the potential carcinogenicity of food dyes.
Carol Potera, “DIET AND NUTRITION: The Artificial Food Dye Blues,” Environ Health Perspect. 2010 Oct; 118(10): A428.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2957945/
–FDA should acknowledge the potential carcinogenicity of the preservatives sodium nitrate and sodium nitrite in deli meats.
–FDA should explain the health risks posed by pesticide residues on fruits and vegetables. Many pesticides are suspected carcinogens. Why should we have to rely on independent organizations like Environmental Working Group and their lists of the “Dirty Dozen” and “Clean 15”? EWG’s Shopper’s Guide represents that organization’s analysis of the latest fruit and vegetable testing data from the Dept. of Agriculture and FDA. Why doesn’t FDA take a prominent role in discussing the risks of pesticide residues?
Final Words
In my opinion, FDA needs a major overhaul if it hopes to gain the confidence of the public. In my opinion, the pharmaceutical industry continues to have a tremendously negative impact on FDA and on its ability to determine whether drugs are indeed “safe and effective.” In my opinion, just because a drug is still on the market does not mean that it meets the layman’s definition of those two words.
In my opinion,
–FDA should acknowledge that modern medicine is better against acute conditions and infections in comparison to chronic conditions.
–FDA should acknowledge that chemistry has triumphed over nutrition and lifestyle changes in our health care system.
–FDA should not normalize or legitimize Pharma’s mechanistic and reductionist view of the human body. FDA should not legitimize Pharma’s narrative based on a pill for every ill.
–FDA should acknowledge the tremendous potential for prevention. FDA should acknowledge that a focus on nutrition and healthy lifestyles can very often be superior to pills.
–FDA should acknowledge the extreme difficulty of balancing the interests of consumers against the interests of the pharmaceutical industry.
Dennis Miller, R.Ph. is a retired chain store pharmacist. His book, The Shocking Truth About Pharmacy: A Pharmacist Reveals All the Disturbing Secrets, can be downloaded in its entirety at Amazon for 99 cents.
