The Regulatory Capture of the U.S. Health Agencies
Part 3 of Series: Reasons Not to Trust Big Pharma
If you read my last article on the propaganda campaign against ivermectin, you may have read the quote by Dr. Pierre Kory which ended the article:
“Most of the healthcare agencies are captured.”1
This article will expand upon that statement: what it means, the evidences for it, and how it came to be this way.
Outline of Article:
II. The Evidences for Regulatory Capture
A. The Revolving Door of Politics and Big Pharma
C. Coercive Pressure
D. Conflicts of Interest
1. The case of Dr. Paul Stolley and Lotronex/alosetron
2. The case of Brilinta
3. The case of Seroquel
4. The case of Dr. David Graham and Vioxx
E. Examples of Drugs Recalled After FDA-Approval
First of all, what is “regulatory capture”? Investopedia defines it as:
“an economic theory that says regulatory agencies may come to be dominated by the industries or interests they are charged with regulating. The result is that an agency, charged with acting in the public interest, instead acts in ways that benefit incumbent firms in the industry it is supposed to be regulating. Industries devote large budgets to influencing regulators, while individual citizens spend only limited resources to advocate for their own rights.”2
This article will address this theory as it pertains to the capture of U.S. healthcare agencies by Big Pharma. When using the term “Big Pharma”, I am referring to large pharmaceutical corporations which have significant political influence, and which have a history of using coercive and manipulative means of achieving their goals.
The healthcare agencies are captured by other corporate interests in general, but that is outside the scope of this series. The methods by which they are captured include “revolving doors, informational lobbying, coercive pressure, and influence over committees.”3
Further, this article argues that these means of entrapment force certain regulatory outcomes.
II. The Evidences For Regulatory Capture
In 2000, the FDA approved Lotronex (aka alosetron) to treat irritable bowel syndrome in women, although there was concern raised from within the FDA regarding the drug having a potentially fatal side effect. The concern was valid: the FDA ended up recalling the drug a year later after it led to multiple fatalities, and to serious adverse events in 1/1000 patients (the risk is further increased to 1/200 after being on the drug for three months).4 After lobbyists, including the Lotronex Action Group, lobbied for the drug’s return, the FDA allowed a restricted approval, despite passionate warnings from senior FDA members regarding the possibility of more deaths. The drug is still sold today.5
Richard Horton, the renowned editor of the The Lancet, wrote that this incident: “reveals not only dangerous failings in a single drug’s approval and review process but also the extent to which the FDA—its Center for Drug Evaluation and Research in particular—has become a servant of the industry.” He criticized in particular the funding of the FDA’s Center for Drug Evaluation and Research primarily by pharmaceutical manufacturers, and he argued that the reintroduction of alosetron was due to private meetings with representatives of the drug manufacturer, GlaxoSmithKline.6
In 2005, The British Medical Journal conducted a report on the “influence of the pharmaceutical industry” and learned the following:
“[Though the pharmaceutical industry’s] declared goal is ‘to bring patients life-enhancing medicines’, [it] buys influence over doctors, charities, patient groups, journalists, and politicians, and [its] regulation is sometimes weak or ambiguous.”7
The following sections address some of the ways the pharmaceutical industry maintains influence and control over the regulatory agencies and American politics:
A) The Revolving Door of Politics and Big Pharma
The “revolving door” references the frequent phenomenon of influential employees of healthcare and other government agencies subsequently working for pharmaceutical companies, and members of pharmaceutical companies subsequently working for healthcare and other governmental agencies. This phenomenon is well-known and Elizabeth Warren referred to it when Scott Gottlieb, FDA commissioner under Trump, resigned and was put on the Pfizer board several months after. She said this about it:
“this kind of revolving door influence-peddling smacks of corruption, and makes the American people rightfully cynical and distrustful about whether high-level Trump Administration officials are working for them, or for their future corporate employers.”8
While FDA commissioner, Gottlieb enacted several policies which directly benefited Big Pharma corporations. For instance, he sped up drug approval which, according to the LA Times, meant “drug companies can begin profiting more quickly from their discoveries.”9 The case of Gottlieb is not an isolated one; nine of the last ten FDA commissioners have worked for pharmaceutical companies after resigning from the FDA.10
The following is a brief list of a few more revolving door cases:
Steve Ricchetti, current Counselor to the President under Biden and chairman of Biden’s 2020 presidential campaign.11 Also worked as Chief of Staff to Biden during the Obama admin, and as Deputy Chief of Staff for operations under Bill Clinton. In between his work in the various administrations, he founded his own lobbying firm, and has since continuously profited off of his relationships with Big Pharma. One Washington Post columnist wrote of him that he “has been through the revolving door more often than a bellhop at the Mayflower Hotel.” In addition, Tony Podesta, another well-known lobbyist, bragged of his and Ricchetti’s family’s influence within the government, saying "The Medicis controlled everything…[but] we have it split into two families.”12
Elizabeth Fowler, the current Director of the Center for Medicare and Medicaid Innovation Center. Fowler helped draft and pass the Affordable Care Act before working as VP for global health policy at Johnson & Johnson.13 She has repeatedly passed legislation in favor of Big Pharma.14
Alex Azar, former U.S. Secretary of Health and Human Services (HHS) (2018-2021). Before he was nominated by Trump to his position, he was a president and top lobbyist of Eli Lilly and Company, a large pharmaceutical company. Under his leadership, the price for insulin made by Eli Lilly and Company tripled, and his company was accused of exploitation. Senator Amy Klobuchar said of Azar’s nomination: “I have often said that the pharmaceutical industry owns Washington. Now with this action today they are actually running it.”15
Joe Grogan, formerly a top lobbyist for Gilead Sciences, served on the White House Coronavirus Task Force under Trump as “Director of the Domestic Policy Council.” About Grogan’s appointment, Robert Klitzman, director of a bioethics program at Columbia University, said:
“Does he have a conflict of interest? Yes! Gilead could help shape a government request for proposals so that they have an unfair advantage. When [Grogan] gets out of office, [Gilead] could give him a gift for doing a good job or just hire him again. And what about his buddies? I’m sure he is still close to people who work for Gilead who will benefit. These are all major ethical concerns.”16
This is not an unusual phenomenon either. OpenSecrets.org revealed that 82.35% of Pfizer’s lobbyists in 2020 were “revolvers”:17
One of the main ethical concerns raised by this phenomenon is that members of healthcare agencies may trade their regulatory influence in exchange for a high-paying corporate job afterwards. There are no rules in the U.S. that limit when a policymaker can join a private corporation — they may do so immediately after resigning from their governmental position.18
A co-writer of a 2016 British Medical Journal study that examined the influence of Big Pharma on regulators, said:
“When your No. 1, major employer after you leave your job is sitting across the table from you, you’re not going to be a hard-ass when you regulate. That’s just human nature.”19
Most are aware of the undemocratic effects of lobbying. Lobbying is an attempt by corporate industries to influence the decisions of elected officials. The more well-funded the lobbyist, the more influence they tend to have over elected officials and the better able they are at achieving their goal: legislation which favors their industry and interests.
Pharmaceutical Research and Manufacturers of America (PhRMA), the largest lobbying group representing the interests of Big Pharma, has paid Congress over $428 million since 1998, and $92 million in the first quarter of 2021 alone. Big Pharma lobbyists have also lobbied non-legislative politicians and have contributed $4.7 billion to them between 1998-2021.20 They have also contributed significant amounts to federal candidates and political parties. Between the period of 1998-2005, Big Pharma has lobbied on at least 1,600 pieces of legislation and they have more than 1,000 registered lobbyists working for them in Washington, D.C..21 22
The non-partisan Sunlight Foundation found that for every $1 spent by lobbying corporations, they received $760 from federal government business and support.23
C) Coercive Pressure
After he was ousted from his position as FDA Commissioner in 1969, Dr. Herbert Ley said, in an interview to The New York Times, that he was under "constant, tremendous, sometimes unmerciful pressure" from pharmaceutical companies, and that their lobbyists, as well as politicians funded by these same lobbyists, would put him under “tremendous pressure” in attempts to prevent him and other members of the FDA from restricting their drugs. Ley said the issue came down to money, “pure and simple” and believes one of the main reasons he was ousted is due to his work on a massive FDA report which would have “gored too many people” within the pharmaceutical companies.24
Some may think that 1969 (the year Dr. Ley was ousted) was a long time ago, and that the FDA must have since reformed. However, though there have been some reforms, nine FDA scientists under G.W. Bush were still complaining of pressure to alter data in favor of pharmaceutical companies. Their concerns were outlined in a 2006 report conducted by the British Medical Journal.25
Another example of coercive pressure was demonstrated in news recently broken: reports of Pfizer bullying Latin-American countries during COVID-vaccine negotiations, asking them to give sovereign assets such as military bases as collateral in case Pfizer was sued in cases not only due to adverse events in citizens, but in cases alleging “negligence, malice, or fraud” on the part of Pfizer.26
The Director of the WHO Center on National and Global Health Law, Professor Lawrence Gostin, said in response to this:
“Pharmaceutical companies shouldn’t be using their power to limit life-saving vaccines in low and middle-income countries. [This] seems to be exactly what they’re doing. Some liability protection is warranted, but certainly not for fraud, gross negligence, mismanagement, failure to follow good manufacturing practices. Companies have no right to ask for indemnity for these things.”27
D) Conflicts of Interest
1) The case of Dr. Paul Stolley and Lotronex/alosetron
It is well known that drug companies fund the FDA. In fact, 75% of the FDA’s drug oversight budget is funded by Big Pharma.28 When Dr. Paul Stolley was hired to become a senior consultant in the FDA’s Scientific Advisory committee in 2000, he voiced his concerns about the FDA becoming a “servant of industry, where dissenting voices are intimidated and ostracized and where scientific debate is repressed.” He said further:
“I think it's a shame how it has fallen down on the job, and Lotronex/alosetron is a perfect example. The FDA was in partnership with industry. It should have been negotiating, not in partnership. Why was it in partnership? Because it's financially supported by industry.”29
The following is a recounting of Stolley’s story:
Two months after beginning his work with the FDA, Stolley wrote a memo to GlaxoSmithKline, warning that their “risk management plan” for their drug alosetron could not prevent the increasing number of “deaths, colectomies, ischemic colitis, and complications of treatment that were never seen previously in the management of irritable bowel syndrome.” Stolley noted that GlaxoSmithKline representatives "aggressively attacked the…memo as being ‘crappy’ and full of errors, while senior FDA officials sat by and failed to defend their staff.”
Stolley said in response: “What message is this sending to young epidemiologists? In my opinion it is sending the message that we don't argue with drug companies; we listen to their distortions and omissions of evidence and we do nothing about it.”
The only comment on the meeting from the current acting Commissioner of the FDA, Janet Woodcock, was the following inspiring statement: “The FDA wanted to determine a course forward, not to argue the details.”30
Stolley noted that from that point on, he was “frozen out of discussions about alosetron’s future.” When he did eventually get a call from Woodcock, instead of praising him for warning of adverse events, he said she “blamed him for ‘brow-beating’ colleagues about its risks and [she] said the drug should be back on the market.”
In response to this, Stolley said it felt like “they cut my legs off”, as well as restricted the actions of other committee members concerned about the drug. He resigned from the FDA six months later, six months before he was due to leave.
Later, Stolley’s concerns about the pharmaceutical industry’s influence within the FDA seemed vindicated as “internal emails from the time seem to support Stolley's suspicions of an unhealthy closeness between senior officials at the FDA, including Woodcock, and senior officials at the company.”31
Stolley said: “[The FDA] is confused and frightened. It's getting its money from industry now and it's afraid to offend these companies. And remember Big Pharma was one of the biggest contributors to the Bush campaign.” (Note that the same is true of Biden, whose presidential campaign Newsweek reported was “backed by Big Pharma”, receiving more than $5.9 million from them during the campaign.)32
In an article published on the NIH website, journalist Ray Moynihan notes: “The public transcripts of the three official advisory committee hearings on alosetron show a pattern of company representatives framing the [irritable bowel syndrome] disorder in such a way as to maximise its severity and prevalence—playing up the drug's benefits and minimising the risks of serious adverse events and death. The same transcripts show FDA staff offering a more sober and comprehensive view of the evidence, but always within a deferential framework that never challenged the company's right to market the drug, despite alarming internal assessments of its dangers.”33
In addition to influencing the FDA on this matter, GlaxoSmithKline, the drug manufacturer, also attempted to influence public opinion regarding the prevalence and seriousness of irritable bowel syndrome in a massive way: through the “development of educational programmes to ‘shape’ medical opinion about the ‘disease’ as well as celebrity-driven campaigns to influence public opinion” (including funding an episode of Frasier in which Kelsey Grammar’s wife has the condition.) This paying of celebrities to covertly act as drugs salesmen is a frequent phenomenon.34
2) The case of Brilinta
Another obvious conflict of interest became apparent after the FDA approval (the panel voted seven to one) of Brilinta (aka ticagrelor), manufactured by AstraZeneca. Although none of the FDA advisors had disclosed conflicts of interest, a later investigation revealed that AstraZeneca had paid four FDA advisors after the drug’s approval. One of them, Jonathan Halperin, was paid $200,000 by AstraZeneca over a period of three years. This is not an isolated phenomenon, either. Science reports:
“Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticed—and entirely unpoliced. In examining compensation records from drug companies to physicians who advised FDA on whether to approve 28 psychopharmacologic, arthritis, and cardiac or renal drugs between 2008 and 2014, Science found widespread after-the-fact payments or research support to panel members. The agency's safeguards against potential conflicts of interest are not designed to prevent such future financial ties.”
The following were comments made regarding the approval of Brilinta:
Carl Elliott, a medical ethicist at the University of Minnesota, criticized these “after-the-fact” payments, saying: “You do something positive for a company that you feel confident is going to pay you back for it later on. And they do."
Vinay Prasad, a hematologist-oncologist at Oregon Health & Science University also criticized the practice, saying: “The people who are asked to weigh this evidence impartially often stand to gain tremendously in their further professional careers from a positive relationship with the company…It might not be a ‘quid pro quo,’ but you don't have to evoke that to be very concerned. It's in their best interest to play nice with these companies."
3) The case of Seroquel
Seroquel, which was approved without much resistance by the FDA, later was discovered to lead to cardiac issues and many deaths. Christopher Granger, an FDA advisor, called its approval “a public health tragedy” and AstraZeneca was forced to pay the government $520 million as compensation for “alleged improprieties in the company’s clinical trials.”35
Granger, who received significant amounts from AstraZeneca after the approval of their drug, Seroquel, noted: “I fully realize that when I'm paid by somebody, like every other human being, that may affect the way that I think about things. So I'm not naïve.”
4) The case of Dr. David Graham and Vioxx
In 2004, Dr. David Graham, the Associate Director of the FDA’s Office of Drug Safety, testified to Congress that he was pressured by his supervisors not to publicly declare his safety concerns about the arthritis medication, Vioxx (aka Rofecoxib), even though a pre-approval study showed that the drug carried with it the risk of heart attack, at a rate of 4x compared to another drug.36 The drug manufacturer, Merck, eventually withdrew the drug after five years of being on the market, in which between 88,000 and 140,000 cases of serious heart disease as a result of the drug were reported.37 Graham said that due to his concerns he was “marginalized by FDA management and not asked to participate in the evaluation of any new drug safety issues. It's a type of ostracism."
Further, he said:
“This [corporate culture within the FDA’s Center for Drug Evaluation and Research] also views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards and disrespects drug safety.”38
Former editor of The New England Journal of Medicine, Marcia Angell, said in 2007:
"It's time to take the Food and Drug Administration back from the drug companies.... In effect, the user fee act put the FDA on the payroll of the industry it regulates. Last year, the fees came to about $300 million, which the companies recoup many times over by getting their drugs to market faster."39
E) Brief List of Examples of Prescription Drugs Recalled for Serious Safety Concerns After FDA-Approval
NPR reported in 2017 that as many as one-third of new drugs approved had safety concerns.
The main reason cited by NPR for the safety concerns? “Accelerated approval process.”
Dr. Caleb Alexander, co-director of the John Hopkins Center for Drug Safety and Effectiveness said: “All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective…Nothing could be further from the truth. We learn tremendous amounts about a product only once it's on the market and only after use among a broad population."40
The following is a list of the most prominent examples of drugs recalled for safety concerns. I did not include all for the sake of brevity:
Accutane: acne medicine on the market for 27 years (1982-2009); recalled due to birth defects, miscarriages, premature birth, inflammatory bowel disease, and suicidal tendencies. The drug manufacturer, Hoffman-La Roche, fielded over 7,000 lawsuits, resulting in over $30 million in fines.
Baycol: cholesterol reducer on the market for 3 years (1998-2001); recalled due to kidney failure, 52 deaths, and 385 cases resulting in hospitalization.
Bextra: pain reliever on the market for 3.3 years (2001-2005); recalled due to serious cardiovascular adverse events, including death and stroke
Darvon & Darvocet: opioid pain reliever on the market for 55 years (1955-2010); recalled due to serious toxicity to the heart, resulting in over 2,110 deaths in less than 20 years.
DES (desPLEX): synthetic estrogen used to prevent miscarriage, premature labor, and other pregnancy complications; on the market for 31 years (1940-1971); recalled due to cancer of cervix & vagina, birth defects, and other developmental abnormalities in children of mothers who took the drug. In addition, studies in the 1950s revealed that this drug was not even effective in its stated goal of preventing miscarriage and other pregnancy complications.
Meridia: appetite suppressant on the market for 13 years (1997-2010); recalled due to cardiovascular and stroke risk.
Propulsid: used for heartburn; on the market for 7 years (1993-2000); recalled due to serious cardiac arrhythmia, with some resulting in death.
Quaalude: sedative and hypnotic; on the market for 23 years (1962-1985); recalled due to mania, seizures, convulsions, and death.
Vioxx: pain relieving medication on the market for 5 years (1999-2004); withdrawn due to more than 27,000 heart attacks or sudden cardiac deaths in four years.
Zelnorm: used to treat irritable bowel syndrome; on the market for 4 years (2002-2007); recalled due to heart attack, stroke, and angina.41
“Wise men say, and not without reason, that whosoever wished to foresee the future might consult the past.” - Nicolo Machiavelli
The multiple cases outlined here demonstrate a pattern: a pattern of corruption and financial manipulation, both on the parts of Big Pharma and on the parts of the FDA. Though money is just a tool, neither good or bad in itself, the pattern outlined here demonstrates that it has been consistently used for nefarious means within regulatory agencies in order to influence politics and public health policies, without regard for the patient’s actual health.
This article was the last in the three-part series entitled “Reasons Not to Trust Big Pharma.” It is the author’s wish that the evidences laid out in these three articles were sufficient to raise in the mind of the critical reader rational skepticism as to the motives of the large pharmaceutical corporations and their regulatory partners. One should treat all statements on public health similarly to how one should treat all statements in general: “Trust, but verify.” No one and no thing should be beyond questioning. If, in a free society, certain things are not permitted to be questioned nor to be approached with a discerning eye, then one should question whether that society is actually free.
It’s been an honor writing this series for CulturalHusbandry’s newsletter. Subscribe to me @ salij.substack.com if you would like to continue reading more of my work. Approximately one article will be produced per week
My next work will be a two-part series. The first part will be on how a free people can become enslaved, and the second on how to liberate an enslaved people, both drawing from historical examples to support the argument.
Links to previous articles in this series:
1) Pfizer's Immoral History
2) Big Pharma Versus Ivermectin
1 “Ivermectin — Experts slams ‘absurd’ regulatory opposition to ‘drug that could end pandemic.’” Newstalk. https://www.newstalk.com/news/ivermectin-expert-slams-absurd-regulatory-opposition-to-drug-that-could-end-pandemic-1238674
2 “Regulatory Capture.” Investopedia. https://www.investopedia.com/terms/r/regulatory-capture.asp
3 “Regulatory Capture: A Review.” Oxford Review of Economic Policy. https://academic.oup.com/oxrep/article-abstract/22/2/203/334718?redirectedFrom=fulltext.
4 “Lotronex (alosetron hydrochloride) Tablets. Full Prescribing Information.” Lotronex. https://web.archive.org/web/20170510120415/https://www.lotronex.com/hcp/_docs/Lotronex_PI.pdf.
5 “Alosetron: a case study in regulatory capture, or a victory for patients’ rights?” U.S. National Library of Medicine: National Institutes of Health. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1124108/.
6 “Lotronex and the FDA: a fatal erosion of integrity.” The Lancet. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(00)04776-0/fulltext.
7 “The Influence of Big Pharma.” The British Medical Journal. https://www.bmj.com/content/330/7496/855.full.
8 “Elizabeth Warren calls on Trump's former FDA commissioner to resign from Pfizer.” USA Today. https://www.usatoday.com/story/news/politics/2019/07/03/elizabeth-warren-tells-scott-gottlieb-resign-pfizer-board/1637789001/
9 “FDA’s program to speed up drug approval shaved nearly a year off the process.” LA Times. https://www.latimes.com/science/sciencenow/la-sci-sn-fda-expedited-drugs-20171205-story.html.
10 “Trust issues deepen as yet another FDA commissioner joins the pharmaceutical industry.” Quartz. https://qz.com/1656529/yet-another-fda-commissioner-joins-the-pharmaceutical-industry/
11 “These Are the Most Influential Operatives on the Biden Campaign.” Washingtonian. https://www.washingtonian.com/2020/10/26/these-are-the-most-influential-operatives-on-the-biden-campaign/.
12 “Biden whisperer, longtime Washington lobbylist helps secure breakthrough in infrastructure talks.” The Washington Post. https://www.washingtonpost.com/us-policy/2021/06/24/biden-whisperer-longtime-washington-lobbyist-center-sculpting-presidents-agenda/.
13 “Former Senate aide Elizabeth Fowler to lead CMS innovation center.” Healthcare Dive. https://www.healthcaredive.com/news/former-senate-aide-elizabeth-fowler-to-lead-cms-innovation-center/595905/.
14 “The Industry Agenda: Big Pharma.” The Revolving Door Project. https://therevolvingdoorproject.org/the-industry-agenda-big-pharma/.
15 “Trump’s HHS secretary nominee boosted drug prices while at Eli Lilly.” Politico. https://www.politico.com/story/2017/11/14/alex-azar-eli-lilly-drug-prices-244888.
16 “Cronyism and Conflicts of Interest in Trump’s Coronavirus Task Force.” The Intercept. https://theintercept.com/2020/02/29/cronyism-and-conflicts-of-interest-in-trumps-coronavirus-task-force/.
17 “Pfizer Inc. Lobbyists.” Open Secrets: Following the Money in Politics. https://www.opensecrets.org/federal-lobbying/clients/lobbyists?cycle=2020&id=D000000138&t0-Former+Members+of+Congress=All.
18 “Regulatory Capture.” See footnote 2.
19 “Are government agency workers ‘here for the right reasons’?” Lown Institute. https://lowninstitute.org/are-government-agency-workers-here-for-the-right-reasons/.
20 “The Industry Agenda: Big Pharma.” See footnote 16.
21 “Drug Bill Demonstrates Lobby’s Pull.” The Washington Post. https://www.washingtonpost.com/wp-dyn/content/article/2007/01/11/AR2007011102081.html.
22 “Drugmakers go furthest to sway Congress.” USA Today. https://usatoday30.usatoday.com/money/industries/health/drugs/2005-04-25-drug-lobby-cover_x.htm.
23 “Fixed Fortunes: Biggest corporate political interests spend billions, get trillions.” Sunlight Foundation. https://sunlightfoundation.com/2014/11/17/fixed-fortunes-biggest-corporate-political-interests-spend-billions-get-trillions/.
24 “Ousted F.D.A. Chief Charges 'Pressure' From Drug Industry.” The New York Times. https://www.nytimes.com/1969/12/31/archives/ousted-fda-chief-charges-pressure-from-drug-industry-ousted-fda.html.
25 “FDA Scientists Ask Obama to Restructure Drug Agency.” The Wall Street Journal. https://www.wsj.com/articles/SB123142562104564381.
26 “Pfizer accused of ‘bullying’ Latin American countries during vaccine negotiations. Pharmaceutical Technology. https://www.pharmaceutical-technology.com/news/company-news/pfizer-latin-american-vaccine/.
27 “Pfizer accused of ‘bullying’ Latin American countries during vaccine negotiations.” See footnote 26.
28 “The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem?” Forbes. https://www.forbes.com/sites/johnlamattina/2018/06/28/the-biopharmaceutical-industry-provides-75-of-the-fdas-drug-review-budget-is-this-a-problem/.
29 “Alosetron: a case study in regulatory capture, or a victory for patients’ rights?” See footnote 5.
30 “Alosetron.” See footnote 5
31 “Alosetron.” See footnote 5.
32 “Big Pharma Backs Joe Biden, But People Don’t Think He’ll Fix Drug Pricing.” Newsweek. https://www.newsweek.com/big-pharma-joe-biden-fix-drug-pricing-1534809.
33 “Alosetron.” See footnote 5.
34 “Celebrity selling.” The British Medical Journal. https://www.bmj.com/content/324/7349/1342.short.
35 “Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns.” Science. https://www.science.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-ethical.
36 “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis.” The New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJM200011233432103.
37 “The Cover-Up Artist.” Slate. https://slate.com/technology/2011/11/sandusky-cover-up-why-is-kenneth-frazier-leading-the-investigation-at-penn-state.html.
38 “Testimony of David J. Graham, MD, MPH, November 18, 2004.” United States Senate: Committee on Finance. https://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf.
39 “Taking Back the FDA.” Boston.com. https://www.boston.com/yourlife/health/diseases/articles/2007/02/26/taking_back_the_fda/.
40 “One-Third of New Drugs Had Safety Problems After FDA Approval.” NPR. https://www.npr.org/sections/health-shots/2017/05/09/527575055/one-third-of-new-drugs-had-safety-problems-after-fda-approval.
41 “FDA-Approved Prescription Drugs Later Pulled from the Market.” Britannica’s ProCon.org. https://prescriptiondrugs.procon.org/fda-approved-prescription-drugs-later-pulled-from-the-market/