Big Pharma

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Publication bias[edit]

Another problem with the influence of pharmaceutical corporations is the possibility of publication bias in research they sponsor. Pharmaceuticals carrying out their own clinical trials must register the trials in a database by law, but they are not required to disclose the results of all of their trials. This enables them to inflate the effectiveness of a drug by sitting on negative trial data.[1] Ben Goldacre is a noted critic of the way in which pharmaceutical companies refuse to release the data from negative and inconclusive trials.

Medical experiments, coverups and other controversies[edit]

  • The Tuskegee Study of Untreated Syphilis in the Negro Male[2][3][4] (informally referred to as the "Tuskegee Syphilis Experiment", the "Tuskegee Syphilis Study", the "Tuskegee Study of Untreated Syphilis in the African American Male", the "U.S. Public Health Service Syphilis Study at Tuskegee", or the "Tuskegee Experiment") was an ethically abusive study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Centers for Disease Control and Prevention (CDC).[5][6] The purpose of this study was to observe the natural history of untreated syphilis.
  • Between 1949 and 1969, open-air tests of biological agents were conducted 239 times. In 80 of those experiments, the Army said it used live bacteria that its researchers at the time thought were harmless. In the others, it used inert chemicals to simulate bacteria.
  • In the 1950s, army researchers dispersed Serratia on Panama City and Key West Florida with no known illnesses resulting.
  • In the 1950s, army researchers dispersed zinc cadmium sulfide (now a known cancer-causing agent) over Minnesota and other Midwestern states to see how far they would spread in the atmosphere. The particles were detected more than 1,000 miles away in New York state.
  • Bacillus globigii, never shown to be harmful to people, was released in San Francisco, New York, Washington, D.C., and along the Pennsylvania Turnpike, among other places.
  • In New York, military researchers in 1966 spread Bacillus subtilis variant Niger, also believed to be harmless, in the subway system by dropping lightbulbs filled with the bacteria onto tracks in stations in midtown Manhattan. The bacteria were carried for miles throughout the subway system. Army officials concluded in a January 1968 report that: "Similar covert attacks with a pathogenic disease-causing agent during peak traffic periods could be expected to expose large numbers of people to infection and subsequent illness or death."
  • In a May 1965 secret release of Bacillus globigii at Washington's National Airport and its Greyhound Lines bus terminal, more than 130 passengers were exposed to the bacteria traveling to 39 cities in seven states in the two weeks following the mock attack.[7]

Johnson & Johnson[edit]

1995: J&J incurs a $7.5 million fine for destroying documents to cover up an investigation into wrongful marketing of its Retin-A acne cream to remove wrinkles.

1996: J&J pays out an undisclosed settlement on false claims over false condom protection claims to protect against HIV and other STDs.

2001: J&J pays out a cool $860 million in a class action lawsuit for misleading customers about prematurely discarding its 1-Day Acuvue soft contact lens. J&J recommended they should be worn only once, but then it was discovered the lenses were no different than the regular Acuvue lens that last two weeks.

2010: J&J shells out an $81 million settlement for misbranding its anti-epileptic drug Topamax to treat psychiatric disorders, plus they hired outside physicians to join their sales force to promote the drug for unapproved conditions. Just one year later, J&J paid $85 million for similar charges against its Natrecor, a deadly heart drug.

2011: Several of J&J’s BABY products were discovered to contain carcinogenic ingredients.

2013: The U.S. Justice Department charged J&J $2.2 billion in criminal fines for marketing its autism and anti-psychotic drug Risperdal for unapproved uses.

Pfizer[edit]

Pfizer is party to a number of lawsuits stemming from its pharmaceutical products as well as the practices of various companies it has merged with or acquired.[8][9][10]

Quigley Co.[edit]

Pfizer acquired Quigley in 1968, and the division sold asbestos-containing insulation products until the early 1970s.[11] Asbestos victims and Pfizer have been negotiating a settlement deal that calls for Pfizer to pay $430 million to 80 percent of existing plaintiffs. It will also place an additional $535 million into an asbestos settlement trust that will compensate future plaintiffs as well as the remaining 20 percent of current plaintiffs with claims against Pfizer and Quigley. The compensation deal is worth $965 million all up. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million will come from insurance policies.[12]

Bjork–Shiley heart valve[edit]

Pfizer purchased Shiley in 1979 at the onset of its Convexo-Concave valve ordeal, involving the Bjork–Shiley heart valve. Approximately 500 people died when defective valves failed and, in 1994, the United States ruled against Pfizer for ~$200 million.[13][14]

Abdullahi v. Pfizer, Inc and Trovafloxacin (Trovan) Controversy.[edit]

In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to Kano, Nigeria to set up a clinical trial and administer an experimental antibiotic, trovafloxacin, to approximately 200 children.[15] Local Kano officials report that more than 50 children died in the experiment, while many others developed mental and physical deformities.[16] The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa.[17] In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment.[18] According to the news program Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug."[19] The lawsuits also accuse Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. While the specific facts of the case remain in dispute, both Nigerian medical personnel and at least one Pfizer physician have stated that the trial was conducted without regulatory approval.[20][21]

In 2007, Pfizer published a Statement of Defense letter.[22] The letter states that the drug's oral form was safer and easier to administer, that Trovan had been used safely in over 5000 Americans prior to the Nigerian trial, that mortality in the patients treated by Pfizer was lower than that observed historically in African meningitis epidemics, and that no unusual side effects, unrelated to meningitis, were observed after 4 weeks.

In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.[23]

In December 2010, WikiLeaks released US diplomatic cables, which indicate that Pfizer had hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action.[24] Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail."[19] In response, the company has released a press statement describing the allegations as "preposterous" and stating that they acted in good faith.[25] Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case,[26] was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.[27][28]

Retrovirus lawsuit[edit]

A scientist claims she was infected by a genetically modified virus while working for Pfizer. In her federal lawsuit she says she has been intermittently paralyzed by the Pfizer-designed virus. "McClain, of Deep River, suspects she was inadvertently exposed, through work by a former Pfizer colleague in 2002 or 2003, to an engineered form of the lentivirus, a virus similar to the one that can lead to acquired immune deficiency syndrome, also known as AIDS."[29] The court found that McClain failed to demonstrate that her illness was caused by exposure to the lentivirus,[30] but also that Pfizer violated whistleblower laws.[31]

Blue Cross Blue Shield[edit]

Health insurance company Blue Cross Blue Shield (BCBS) filed a lawsuit against Pfizer for reportedly illegally marketing their drugs Bextra, Geodon and Lyrica. BCBS is reporting that Pfizer used "kickbacks" and wrongly persuaded doctors to prescribe the drugs.[32][33] FiercePharma reported that "According to the suit, the drugmaker not only handed out those "misleading" materials on off-label uses, but sent doctors on Caribbean junkets and paid them $2,000 honoraria in return for their listening to lectures about Bextra. More than 5,000 healthcare professionals were entertained at meetings in Bahamas, Virgin Islands, and across the U.S., the suit alleges."[34][35] The case was settled in 2014 for $325M.[36]

Brigham Young University[edit]

Controversy arose over the drug "Celebrex". Brigham Young University (BYU) said that a professor of chemistry, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that would later lead towards the development of Celebrex. BYU was originally seeking 15% royalty on sales, which would equate to $9.7 billion. The court filings show that a research agreement was made with Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme that Dr. Simmons claims to have discovered would induce pain and inflammation while causing gastrointestinal problems, which Celebrex is used to reduce those issues. A battle ensued, lasting over six years, because BYU claimed that Pfizer did not give him credit or compensation while Pfizer claims it had met all obligations regarding the Monsanto agreement. This culminated in a $450 million amicable settlement without going to trial. Pfizer said it would take a $450 million charge against first quarter earnings to settle.[37]

Litigation in which Pfizer was not a party[edit]

Pfizer was discussed as part of the Kelo v. New London case that was decided by U.S. Supreme Court in 2005. In February 1998 Pfizer announced it would build a research facility in New London, Connecticut, and local planners, hoping to promote economic development and build on the influx of jobs the planned facility would bring to the town, created a plan that included seizing property to redevelop it under eminent domain, and local residents sued to stop the seizure. The case went to the Supreme Court, and with regard to Pfizer, the court cited a prior decision that said: "The record clearly demonstrates that the development plan was not intended to serve the interests of Pfizer, Inc., or any other private entity, but rather, to revitalize the local economy by creating temporary and permanent jobs, generating a significant increase in tax revenue, encouraging spin-off economic activities and maximizing public access to the waterfront”.[38] The Supreme Court allowed the eminent domain to proceed.[38] Pfizer opened the facility in 2001 but abandoned it in 2009, angering residents of the town.[39]

Environmental record[edit]

Between 2002 and 2008, Pfizer reduced its greenhouse emissions by 20%,[40] and committed to reducing emissions by an additional 20% by 2012. In 2012 the company was named to the Carbon Disclosure Project's Carbon Leadership Index in recognition of its efforts to reduce greenhouse gas emissions.[41]

Pfizer has inherited Wyeth's liabilities in the American Cyanamid site in Bridgewater, New Jersey. This site is highly toxic and an EPA declared Superfund site. Pfizer has since attempted to remediate this land in order to clean and develop it for future profits and potential public uses.[42] The Sierra Club and the Edison Wetlands Association have come out in opposition to the cleanup plan, arguing that the area is subject to flooding, which could cause pollutants to leach. The EPA considers the plan the most reasonable from considerations of safety and cost-effectiveness, arguing that an alternative plan involving trucking contaminated soil off site could expose cleanup workers. The EPA's position is backed by the environmental watchdog group CRISIS.[43]

In June 2002, a chemical explosion at the Groton plant injured seven people and caused the evacuation of over 100 homes in the surrounding area.[44]

Political lobbying[edit]

Pfizer is a leading member of the U.S. Global Leadership Coalition, a Washington D.C.-based coalition of over 400 major companies and NGOs that advocates for a larger International Affairs Budget, which funds American diplomatic, humanitarian, and development efforts abroad.[45]

Pfizer is one of the single largest lobbying interests in United States politics. For example, in the first 9 months of 2009 Pfizer spent over $16.3 million on lobbying US congressional lawmakers, making them the sixth largest lobbying interest in the US (following Pharmaceutical Research and Manufacturers of America (PhRMA), which ranked fourth but also represents many of their interests). A spokeswoman for Pfizer said the company “wanted to make sure our voice is heard in this conversation” in regards to the company's expenditure of $25 million in 2010 to lobby health care reform.[46]

According to U.S. State Department cables released by the whistleblower site WikiLeaks, Pfizer "lobbied against New Zealand getting a free trade agreement with the United States because it objected to New Zealand's restrictive drug buying rules and tried to get rid of New Zealand's former health minister, Helen Clark, in 1990.[47]

In an example of the revolving door between government and industry in the United States, Scott Gotlieb, who resigned as the US FDA Commissioner in April 2019, joined the Pfizer board of directors three months later, in July.[48]

AstraZeneca[edit]

In June of 2003, AstraZeneca pleaded guilty to a felony charge of health care fraud and agreed to pay $355 million to settle criminal and civil accusations that it engaged in a nationwide scheme to illegally market a prostate cancer drug. -- New York Times

Nexium, the successor to Prilosec, has according to some commentators "become a symbol of everything that is wrong with the pharmaceutical industry".[1] The issue was that of evergreening patents, which in effect would extend the market dominance of certain proprietary medicines. Esomeprazole is a single stereoisomer of omeprazole and based upon available evidence there seems to be little difference between the two in dose-related response. However, AZ as owners of the lucrative Losec patent sought to extend domination of the PPI market with Nexium, marketed as the successor to the original drug. Though identical in biological action, the new drug could be patented, thus achieving "evergreening" of the product and maintaining market share.

Notes[edit]

References[edit]

  1. Publication Duty for Big Pharma, PloS Medicine
  2. Newkirk, Vann R. II (June 17, 2016). "A Generation of Bad Blood". The Atlantic. Archived from the original on December 18, 2020. Retrieved 18 December 2020. Known officially as the Tuskegee Study of Untreated Syphilis in the Negro Male ...<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  3. Shamim M Baker, Otis W Brawley, Leonard S Marks (June 2005). "Effects of untreated syphilis in the negro male, 1932 to 1972: a closure comes to the Tuskegee study, 2004" (PDF). Urology. 65 (6): 1259–62. doi:10.1016/j.urology.2004.10.023. PMID 15922414. Archived (PDF) from the original on September 15, 2012. Retrieved 18 December 2020. The study was officially titled “The Effects of Untreated Syphilis in the Negro Male.”CS1 maint: multiple names: authors list (link)<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  4. "The Tuskegee Timeline". U.S. Public Health Service Syphilis Study at Tuskegee. U.S. Centers for Disease Control and Prevention. Archived from the original on May 10, 2019. Retrieved 18 December 2020. It was called the “Tuskegee Study of Untreated Syphilis in the Negro Male.”<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  5. Brandt, Allan M. (December 1978). "Racism and Research: The Case of the Tuskegee Syphilis Study". The Hastings Center Report. 8 (6): 21–29. doi:10.2307/3561468. JSTOR 3561468. PMID 721302. Archived from the original on January 18, 2021. Retrieved June 27, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
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  7. Cite error: Invalid <ref> tag; no text was provided for refs named wall
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  9. Cite error: Invalid <ref> tag; no text was provided for refs named wapo offlabel
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  11. The Quigley Company, Inc. Trust Quigley Company reorganization
  12. Crown, Reign (2012). Master. Booktango. ISBN 978-1-4689-2014-7. over $965 million in settlements<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  13. Blackstone, E.H. (2005). "Could It Happen Again?: The Bjork–Shiley Convexo-Concave Heart Valve Story". Circulation. 111 (21): 2717–2719. doi:10.1161/circulationaha.105.540518. PMID 15927988. Archived from the original on June 8, 2011. Retrieved June 21, 2010.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  14. Bloomfield, P.; et al. (1991). "Twelve-year comparison of a Bjork–Shiley mechanical heart valve with porcine bioprostheses". N Engl J Med. 324 (9): 573–579. doi:10.1056/nejm199102283240901. PMID 1992318.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  15. Oldani, Michael (2016), "Trovafloxacin (Trovan) Controversy", The SAGE Encyclopedia of Pharmacology and Society, SAGE Publications, Inc., pp. 1444–1447, doi:10.4135/9781483349985.n409, ISBN 9781483350004, retrieved 2019-01-21<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
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  20. Panel Faults Pfizer in '96 Clinical Trial In Nigeria. The Washington Post. May 7, 2006
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  44. The tempest. The Washington Post. May 28, 2006
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  48. Mishra, Manas (2 July 2019). Kuber, Shailesh (ed.). "Senator Warren asks former FDA chief Gottlieb to resign from Pfizer board". Reuters. Retrieved 4 July 2019.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>

See also[edit]

Books[edit]

  • Big Pharma: How the World's Biggest Drug Companies Control Illness is a 2006 book by British journalist Jacky Law.
  • Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients is a book by the British physician and academic Ben Goldacre
  • Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial is a nonfiction book by investigative journalist Alison Bass
  • Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America is a book by Robert Whitaker

External links[edit]

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Medicine and publication/media bias