Treatments for medical problems have been used since the beginning of human civilization. While many illnesses were thought to be the work of supernatural forces, various ancient civilizations created unique systems for treating individuals using, among other things, herbal remedies.
Despite a lack of scientific knowledge and use of modern technology, many of these early remedies were useful and are still currently used. The beginning of pharmacy practice goes back as far as the Middle Ages. However, the industry we know had its roots in the 19th century.
Since then, it has become one of the most profitable and influential industries. In the past, many drugs were discovered by accident or through the identification of an active ingredient used in traditional remedies.
The pharmaceutical industry of the 21st century chooses a different approach, attempting to understand disease and infection at the molecular and physiological level and then targeting the development of drugs based on this knowledge.
The marriage of experimentation and the Industrial Revolution was likely first undertaken by Merck in Germany as they moved toward the manufacturing and selling of alkaloids. As the industry and their profits grew, George Merck, founder of Merck, declared:
“We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we remember it, the larger they have been.”
History of FDA commissioners and Big Pharma
Merck’s statement from 1950 continues to resonate within the industry as Big Pharmamanufacturers, markets and sells medicines to the people and for the people, raking in profits that far outweigh the benefits most experience. This is counter to the role given to the U.S. Food and Drug Administration to protect:
“[The] public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.”
After leaving the top leadership position at the FDA, nine out of the last 10 commissioners in the past 33 years have gone on to work for pharmaceutical companies.
This stretch began when Arthur Hayes went on to join E.M. Pharmaceuticals in 1986 after resigning as commissioner in 1983. The last to join this group is the most recent FDA commissioner, Scott Gottlieb, who just announced he is joining Pfizer as a member of their board.
Although none of these moves of past FDA Commissioners to pharmaceutical companies is illegal, the emerging pattern gives the perception of a revolving door, or an unstated agreement between the pharmaceutical industry and those who are charged with regulating the approval of their products.
The single hold out who did not join any pharmaceutical company was David Kessler, who served as the FDA Commissioner from 1990 to 1997 under past President George W. Bush. Kessler went along to serve as the chair of the board of directors at the Center for Science in the Public Interest, a nonprofit nutritional watchdog organization.
He spoke to Quartz, saying he was worried the politicization of the FDA may be seen as a threat to independent, scientific analysis. He is not alone. Concerns were raised 34 years ago, in 1985 when the Chicago Tribune reported that Dr. Alexander Schmidt, commissioner under President Nixon, told state regulators:
“We have more politicization of the agency than is either warranted by rational politics or good for the American people.”
Scott Gottlieb joins ranks with Pfizer
Gottlieb announced his move from FDA commissioner, which he resigned April 5, 2019, to the Pfizer board of directors June 27, 2019, on his Twitter account, posting:
“I’m honored to be joining the board of directors of #Pfizer and working together with more than 90,000 Pfizer colleagues to promote medical innovation, advance patient care, and secure access to better healthcare outcomes for families around the world. @pfizer”
This announcement came just four days after he announced he was joining the advisory board at the National Institute for Health Care Management Foundation. The NIHCM press release reported:
“Gottlieb served under the Trump Administration as the 23rd Commissioner of Food and Drugs from 2017 to 2019, where he improved the efficiency of the regulatory process for novel drugs and medical devices and mobilized action on public health initiatives like teen nicotine use, opioid addiction and drug competition, and promoting affordable access to medicines.”
As Gottlieb splits his time between a nonprofit organization “dedicated to transforming health care through evidence and collaboration” and Pfizer pharmaceutical company whose mission is “to be the premier, innovative biopharmaceutical company,” it may be difficult to split his focus.
Pfizer gets inside scope on biosimilars
During his term at the FDA, Gottlieb pushed several policies intended to speed up drug approvals and use the power of the FDA to encourage greater use of biosimilars, or generic copied versions of more costly biologic drugs used to treat autoimmune diseases and some cancers.
One manufacturer of biosimilar drugs is Pfizer, which had complained about perceived roadblocks to making these drugs more available. With Gottlieb on the board of directors at Pfizer, this may help the big company navigate the FDA rules and regulations more easily. Pfizer executive chairman and former CEO said in a statement:
“Scott’s expertise in health care, public policy and the industry will be an asset to our company and enable our shareholders to continue to benefit from a Board representing a balance of experience, competencies and perspectives.”
Stat News reported in 2018 that board members were given cash retainers of $142,500 plus stock expected to be valued at $159,000 in 2019. Gottlieb will be serving on two board level committees, the Regulatory Compliance Committee and Science and Technology Committee.
Pfizer is now moving more deeply into the treatment of cancer following the acquisition of Array BioPharma and a reorganization establishing businesses in medicine, consumer health care and innovative medicine.
Sydney Wolfe, a founder of Public Citizen Health Research Group had expressed concern about the FDA commissioners ties to industry before Gottlieb joined the agency. Following the announcement Gottlieb would be joining Pfizer, Sidney Wolfe commented to Stat News:
“This is classic and it’s not surprising. Philosophically, he’s returning to the ecosystem where he’s most comfortable. And he’ll get paid very well for it, too.”
CDC director resigns after conflict of interest revealed
While the FDA is currently in the spotlight, the CDC is not far behind. In 2002 Dr. Julie Gerberding was the first woman to be appointed as a director for the CDC. While there she overhauled the structure of the organization causing many of the senior scientists and leaders to leave, as she replaced them with those who had ties to the vaccine industry.
During her years at the CDC, the FDA approved the Gardasil vaccine for human papilloma virus vaccination manufactured by Merck. In 2009, Gerberding left the CDC and later became the president of Merck’s vaccine division.
In early 2018, Alex Azar was appointed as the Secretary to Health in Human Services. Less than 48 hours later, he accepted the resignation from then CDC director Brenda Fitzgerald after it was revealed she purchased shares in tobacco, drug and food companies while serving as the head of the CDC.
Her problems in the organization may have started with her unwillingness to address some aspects of the opioid crisis, but Politico33 reported her purchase of tobacco stock after starting at the CDC may have been the last straw.
Following her resignation, the World Mercury Project team, led by Robert F. Kennedy Jr., issued a press release discussing Merck’s “statistical gimmicks” to conceal Gardasil risks, falsification of mumps vaccine data and the then upcoming merger between Bayer and Monsanto, which was subsequently granted after the companies agreed to sell $9 billion in assets.
Pharmaceutical industry uses influence to protect interests
Pfizer may enlist Gottlieb’s help on more than biosimilar drugs. In late 2018, while Gottlieb was in office at the FDA and in what was seen as a slap in the face to President Trump, Pfizer announced it would increase the list prices on forty-one different drugs in January 2019. This affected 10% of Pfizer’s portfolio, most of which increased 5%.
Just eight days after Gottlieb announced his move to Pfizer, Trump promised an executive order to enable the U.S. government to pay lower prices for prescription drugs. The aim is at a “favored nations clause” placing a limit on the cost to the government for any medication not to be greater than the lowest cost to other nations or companies.
The Affordable Care Act expanded coverage to an additional 16.9 million Americans who were previously uninsured, creating a larger pool of individuals with access to medication. However, while the industry had access to a greater number of individuals, there continues to be a push toward “understanding the characteristics of early adopters” of new medications. Researchers wrote:
“The successful diffusion of new drugs is crucial for both pharmaceutical companies and patients — and of wider stakeholder concern, including for the funding of healthcare provision.”
Trump’s reference in his promised executive order to close the gap in a two-level pricing system for prescription medications is well-known to those who live on the Canadian border. In one evaluation of the 13 largest pharmaceutical companies in the world, 45% of the combined revenue came from sales in the U.S. alone.
This may be due in part to the difference in pricing. Dr. David Belk evaluated medications and pharmaceutical companies finding a vast difference in price per pill between the U.S. and Canada. For instance, Xarelto 20 mg is $14.37 per pill in the U.S. and $3.07 per pill in Canada.
However, he points out the costs are in Canadian dollars and the prices for the U.S. are what the pharmacy pays for the drugs and not what the consumer pays, increasing the price difference. And in a look at the 2011 annual report from Pfizer, Belk finds on page 17 Pfizer reported $67.4 billion in revenues, $9.1 billion on research and development spending and $19 billion on marketing.
He compared some of these same factors in 13 major pharmaceutical companies finding the amount spent on marketing was about 60% more than what they spent on research.
However, the pharmaceutical industry may be using the term “research” loosely. As Mariana Mazzucato, Ph.D., University College of London director for Innovation and Public Purpose discusses, 78% of the patents approved by the FDA correspond to drugs currently on the market.
In other words, the industry is no longer working toward the innovation of new drugs to treat illness, but instead is expending time and energy to extend patents and use other gimmicks to essentially release the same drug and maintain pricing.
Protecting your health may be more important than ever
It may be more important than ever to protect your health. Some of the simplest strategies are to eat a whole food diet, get at least eight hours of quality sleep, exercise daily and move consistently throughout the day. Steer clear of habits that may negatively impact your health, such as smoking and electromagnetic fields.
It is important to remember just small changes may reap big rewards, so don’t get overwhelmed by the thought of making changes. These links to some of my past articles will help provide tips and guidelines to get started.
Written Dr. Joseph Mercola for Mercoia ~ July 17, 2019