Let’s give Dr. Makary a chance as FDA Commissioner. Will he capitulate to Pharma? I can’t see how Pharma could be happy with him as the nominee because he is a strong critic of the medical establishment.
This opinion piece is written by Dennis Miller, R.Ph. He 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.
President-elect Trump nominated Marty Makary, M.D., a well-known critic of the medical establishment, for FDA Commissioner
Marty Makary, M.D., is a professor at the Johns Hopkins School of Medicine.
According to the conservative New York Post,(Nov. 22, 2024), Makary (a contributor to that newspaper) has:
“…railed against the overprescribing of drugs, the use of pesticides on foods and the influence pharmaceutical and insurance companies have over physicians and federal agencies.”
Trump indicated that Makary will work closely with Robert F. Kennedy Jr. – his pick to lead the Department of Health and Human Services – to “properly evaluate harmful chemicals poisoning our Nation’s food supply and drugs and biologics being given to our Nation’s youth, so that we can finally address the Childhood Chronic Disease Epidemic.”
The president-elect touted Makary’s devotion to “improving Medical Quality and lowering Hospital and Drug Costs for all Americans” and his advocacy for “Healthcare Transparency.”
Will Dr. Makary Capitulate to Pharma?
As a pharmacist who is a Democrat, I find the nomination of Dr. Makary for FDA Commissioner to be interesting and promising. Dr. Makary has been interviewed countless times on TV. He does not seem to be the type of person who would accept the job as FDA Commissioner and then capitulate to the pharmaceutical industry. His entire persona seems to be independence and speaking truth to power.
If Dr. Makary capitulates to the pharmaceutical industry, I would be surprised. As a result of reading two of his books, I view Dr. Makary as a person who has much better things to do with his life than to cave in, defer, or submit to Pharma. His entire message seems to be geared to informing the public about the medical establishment. I have a hard time imagining him suddenly surrendering to Pharma upon confirmation as FDA Commissioner. That would seem to go against the entire goal of his professional life.
Dr. Makary doesn’t seem to be the type of person who would acquiesce to what’s widely referred to as “regulatory capture.” That’s a situation in which a governmental entity ends up being a captive of the industry it is supposed to regulate. Critics have complained that FDA has long been a captive of the pharmaceutical industry.
Will Pharma tolerate an FDA Commissioner who rails against the overprescribing of drugs?
I can’t see how Pharma could be happy with an FDA commissioner who rails “against the overprescribing of drugs.” In my opinion, “the overprescribing of drugs” is precisely what Pharma wants. The purpose of direct-to-consumer advertising of prescription drugs is to increase the utilization of drugs. Can any serious person doubt that Pharma encourages “the overprescribing of drugs”? The pharmaceutical industry unquestionably wants people to take more pills.
I Share Many of Dr. Makary’s Concerns:
I, too, am very concerned about “the use of pesticides on foods and the influence pharmaceutical and insurance companies have over physicians and federal agencies.” I, too, am very concerned with processed foods (and the additives they contain), the chronic disease epidemic, healthcare transparency, preventive medicine, and public health.
Dr. Makary focuses on the big picture in medicine rather than the mechanistic and reductionist focus on molecules and cells that Pharma prefers. Makary discusses issues like the epidemic of type 2 diabetes in kids, the medicalization of normal life, medical “dogma,” as well as the harmful effects of microplastics, seed oils, yellow #5, and processed foods. This, to me, is a breath of fresh air because the FDA does not have a history of openly discussing these important issues.
Has there been a realignment in the Democratic and Republican parties as regards health issues?
In my opinion, as a result of the Covid-19 pandemic, there has perhaps been a remarkable realignment or shift in the Democratic and Republican parties as regards many health issues. It used to be that the Republican Party was almost reflexively supportive of Big Business (including Pharma) and the Democratic Party was more likely to be critical of Pharma.
As a result of Covid-19, it seems that the Republican Party is much more likely to criticize Pharma, whereas the Democratic Party seems to be much more supportive of the establishment view of medical issues.
John Abramson, M.D., a major critic of the pharmaceutical industry, has been shunned by mainstream media dependent on Pharma advertising dollars:
John Abramson, M.D., has been on the faculty of Harvard Medical School for twenty-five years, where he teaches health care policy. He is the author of Overdosed America: The Broken Promise of American Medicine (HarperCollins, 2004) and Sickening: How Big Pharma Broke American Health Care and How We Can Repair It (Harper Collins/Mariner, 2022). [You may want to listen to the People’s Pharmacy interview with Dr. Abramson at this link.]
Dr. Abramson is one of my heroes for his searing criticism of the pharmaceutical industry. I have watched most of the interviews of Dr. Abramson on YouTube. He has stated during one or more of those interviews that the mainstream media has not interviewed him for his new book because the mainstream media is so dependent on pharmaceutical industry advertising. Yet Dr. Abramson was interviewed for two and a half hours on Joe Rogan’s podcast. I think most people view Rogan as a conservative on most issues. He endorsed President-elect Trump.
Will Dr. Makary’s ethical standards cause him to resign in a few months after confirmation?
I am extremely critical of Pharma. Even though I am a Democrat, it seems to me that the Republican Party is more likely to criticize the pharmaceutical industry these days than the Democratic Party. That’s why I see the nomination of Dr. Marty Makary as so interesting and promising. I will be very surprised and disappointed if Dr. Makary capitulates to the pharmaceutical industry. I will be watching with great interest.
Here is my wish list for the new FDA Commissioner:
[1] Risks vs. benefits of pharmaceuticals
I would love to see more transparency from FDA about the risks and benefits of pharmaceuticals.
[2] Real-world incidence of side effects
I would like more transparency from FDA about the real-world incidence of drug side effects.
[3] Tighter regulation of generic drugs
I would like to see tighter regulation by FDA of generic drugs made in countries like India, China, and elsewhere around the world.
[4] Number needed to treat
I would like to see FDA require that commercials for prescription drugs disclose the number needed to treat (NNT) and explain the extreme significance of this number.
[5] Absolute risk reduction vs. relative risk reduction
I would like FDA to require that commercials cite “absolute risk reduction” rather than “relative risk reduction” and explain the difference.
[6] Surrogate endpoints
I would like FDA to require that commercials cite “decrease in all-cause mortality” rather than cite “surrogate endpoints” or “surrogate markers” and explain why this is extremely significant.
[7] Diseases of modern civilization
I would like FDA to emphasize the fact that most of the prescriptions pharmacists fill are to treat preventable diseases of modern civilization.
[8] Mismatch between our genes and life in modern societies
I would like FDA to explain the major mismatch or discordance between the typical diets, lifestyles, and chemical exposures in modern society and the conditions that our genes are programmed for.
[9] Modern medicine is not the primary reason for increases in life expectancy
I wish that FDA and CDC would emphasize that the primary reasons for the increases in life expectancy in the last hundred years are public health factors like improved nutrition, improved sanitation, cleaner drinking water, better protection from the elements (improved housing), etc., not pills. Modern medicine has played a role but that role is far more modest than Pharma would like you to believe.
[10] Only two countries allow direct-to-consumer advertising of prescription drugs
I would like FDA to ban direct-to-consumer advertising of prescription drugs. I would like FDA to acknowledge that only two countries (USA and New Zealand) allow this practice. I would like FDA to justify why this country is such an outlier or anomaly in this regard. It seems to me that the rest of the world has concluded that these commercials encourage overmedication and the use of the expensive advertised drugs even though there may be less expensive alternatives available including non-drug approaches. How does FDA justify exposing Americans to such exploitative advertising?
[11] Tumors and cancers in lab animals exposed to commonly-prescribed drugs
I would like FDA to explain the significance of tumors and cancers in lab animals exposed to commonly-prescribed drugs, often at a dose that is not far from the human dose on a pound-for-pound basis. I would like FDA to explain why the agency does not make this information readily available to the public, rather than bury it in the official prescribing information.
[12] Prioritize disease prevention
I would like FDA and CDC to prioritize disease prevention rather than pills. I would like FDA to point out that the only prevention that Pharma likes is “prevention in a pill.” I would like FDA to encourage people to pressure their doctors for preventive approaches and to express disappointment when doctors reflexively resort to prescriptions.
[13] “Brain chemical imbalance” is only conjecture
I would like FDA to acknowledge that the “so-called “brain chemical imbalance” which is the basis for prescribing anti-depressants is pure theory and that there is no proof for such an imbalance.
[14] Acknowledge that Americans are overmedicated
I would like FDA to acknowledge that Americans are overmedicated or, in too many instances, grossly overmedicated.
[15] Acknowledge that FDA has been too aloof, unresponsive, and non-transparent
I would like FDA to acknowledge that it has been too aloof, too unresponsive, and too non-transparent in dealing with the public and in disclosing data. In my opinion, FDA has maintained this posture toward the public because the agency routinely minimizes the risks of pharmaceuticals, food additives, pesticides, etc., due to the fact that the agency has been captured by Big Pharma and Big Food.
[16] FDA and CDC should provide a potent counter-narrative to Pharma’s marketing madness
I would like the FDA and CDC to promote prevention as aggressively as Pharma promotes pills. I would like the FDA and CDC to provide a potent counter-narrative to Pharma’s pill circus. I would like the FDA and CDC to have as great a presence on our airwaves as does the pharmaceutical industry through direct-to-consumer advertising of prescription drugs.
[17] Long-term risks of pharmaceuticals are difficult to determine
I wish the FDA would admit that determining the long-term risks of pharmaceuticals is difficult and that the FDA does a better job addressing imminent hazards of drugs and contaminated foods in comparison to long-term hazards of pills, pesticides, and processed foods.
[18] FDA should model itself on Consumer Reports
I wish that the FDA would model itself on Consumer Reports and would disclose information about the risks of pharmaceuticals, processed foods, and pesticides in a manner that is accessible and understandable to laymen.
[19] FDA’s definition of “safe and effective” is vastly different from the layman’s definition
I would like the FDA to explain how it claims that all the drugs the agency approves are “safe and effective” when drugs are often accompanied by potentially extremely serious side effects such as heart attacks, strokes, and death. Why does the FDA use a definition of “safe and effective” that is so vastly different from the layman’s definition of those two words?
[20] Stronger regulation of pesticides on fresh fruits and vegetables
I wish that the FDA would be far more active in regulating pesticide residues on fresh fruits and vegetables. I wish that the FDA would take the lead in publicizing the levels of pesticide residues the agency finds on fresh fruits and vegetables rather than forcing the public to rely on independent organizations like Consumer Reports and Environmental Working Group to disseminate this information.
[21] Dangers of synthetic chemicals that are ubiquitous in modern society
I wish the CDC would warn us about the dangers of the synthetic chemicals that are ubiquitous in modern societies, in our air, food, water, workplaces, in household cleaners, etc. I wish the FDA and CDC would warn the public about the risks of PFAS (“forever chemicals”).
[22] Avoid processed foods
I wish that FDA would strongly recommend that we avoid processed foods. This will, of course, never happen because FDA is a captive of Big Food.
[23] Prominently indicate the number of food additives on the nutrition label
I wish that the FDA would require the nutrition label on processed foods to indicate the number of additives as prominently as the label currently indicates the number of calories per serving.
[24] Ban high fructose corn syrup
I wish that the FDA would ban high fructose corn syrup.
[25] Ban sodium nitrate and sodium nitrite
I wish that the FDA would ban sodium nitrate and sodium nitrite (both are suspected carcinogens) from deli meats, bacon, hot dogs, etc. even though such a ban could decimate that category of foods.
What Would a Useful FDA Actually Look Like? Can You Imagine an FDA That’s Actually Strongly Pro-Consumer?
Do you feel that FDA is aloof, unresponsive, and non-transparent? Have the FDA and CDC allowed Pharma to hijack the public discourse about health? Should the FDA and CDC promote prevention as aggressively as Pharma promotes pills?
Many people feel that the private sector should take over most of the functions of the federal government. Do you believe that the federal government can’t do anything well?
I realize that the FDA and CDC suffered a hit to their credibility and reputation during the pandemic. My intention is not to defend those agencies. My goal is to describe what I think a truly effective FDA and CDC would actually look like.
In my opinion, the FDA and CDC have tremendous potential if they were to extricate themselves from their subservient posture toward Big Pharma and Big Food and if they were to function in the public interest. From my perspective, the FDA serves the needs of Big Pharma and Big Food far more than it serves the needs of the public.
Can you imagine the FDA and CDC trying to influence your views toward health as aggressively as the drug industry? Can you imagine the FDA and CDC having as many public service announcements about health and prevention as Pharma has advertisements for pills?
Do prescription drug commercials have a greater influence on you than you realize?
In my opinion Pharma has succeeded beyond its wildest dreams in convincing you to want more pills. Even though you may dismiss many of these commercials as hype or hyperbole, is the net effect of these commercials to cause you to think of pills rather than prevention?
In Conclusion:
I hope that Dr. Makary does not capitulate to the pharmaceutical industry as many of his predecessors seem to have done. I hope that he perseveres in what appears to be his fierce independence. I hope that he remakes the FDA into an agency that truly places the public interest above that of Big Pharma and Big Food. Can you imagine an FDA that is actually strongly pro-consumer rather than a captive of Big Pharma and Big Food?
I do worry that President-elect Trump seems to enjoy being photographed eating fast food. I hope that does not indicate that Trump’s stated goal of improving the health of Americans is not genuine. I suspect that he will be very heavily bombarded by Pharma lobbyists to soften the views he stated about overmedication and disease prevention during the nominating process for the heads of the FDA, CDC, and for Surgeon General.
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.
