Big Pharma’s Hydroxychloroquine Push
“There’s worrying news around the world of people self-medicating at
home with the drugs chloroquine and hydroxychloroquine to treat COVID-19,”
writes Parastou Donyai, professor and director of pharmacy practice, University
of Reading (UK).
In the absence of properly conducted scientific studies, lacking US FDA
approval (though FDA approvals often seem dodgy) or approval by proper experts in
the field who actually know what they are talking about—politicians and media are
pushing snake oil cures and quack medicine, unethical physicians and drug
industries eager to rake in the proceeds of medical establishment administering
or individuals' self-medicating potentially lethal drugs. In the mix is a tangled web of pharmaceutical
companies (changing names and acquiring one another, and lawsuits) and
politicians kowtowing and pocketing money from these drug companies to carry on lifestyles in luxury.
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harmaceutical Research and Manufacturers of America (PhRMA) represents
the most powerful drug companies in the United States. Among them is Novartis (Novartis
International AG, headquartered in Switzerland), one of the world’s largest
pharmaceutical companies, by market capitalization and sales
(total assets as of 2018: $145.563 billion; total equity: $78.692 billion; revenue: $51.900 billion)
Novartis is a full member of the European Federation of Pharmaceutical
Industries and Associations (EFPIA), the International Federation of
Pharmaceutical Manufacturers and Associations (IFPMA), and the Pharmaceutical
Research and Manufacturers of America (PhRMA).
According to the CRP’s OpenSecrets, a division of Novartis (Sandoz) “donated
30 million doses of hydroxychloroquine sulfate to the Department of Health and
Human Services”; and in March 2020, Bayer “donated one million doses of medical
grade chloroquine phosphate to the Strategic National Stockpile.” Drug companies, like cigarette companies, don't give without expecting or exacting a return. Nothing is free. And there is this murky record.
US v. Novartis
- · 2005: federal prosecutors opened an investigation into Novartis’ marketing of several drugs: Trileptal, an antiseizure drug; three drugs for heart conditions—Diovan, Exforge, and Tekturna; Sandostatin, a drug to treat a growth hormone disorder; and Zelnorm, a drug for irritable bowel syndrome
- · 2008: US Food and Drug Administration (FDA) sent a notice to Novartis Pharmaceuticals regarding its advertising of Focalin XR, an ADHD drug, in which the company overstated its efficacy while marketing to the public and medical professionals.
- · 2010, Novartis agreed to pay $422.5 million in criminal and civil claims and to enter into a corporate integrity agreement with the US Office of the Inspector General.… ‘Federal prosecutors accused Novartis of paying illegal kickbacks to health care professionals through speaker programs, advisory boards, entertainment, travel and meals.’ Company denied wrongdoing.
- · 2013: federal prosecutors filed two lawsuits against Novartis under the False Claims Act for off-label marketing and kickbacks… Lawsuit 1 ‘accused Novartis of inducing pharmacies to switch thousands of kidney transplant patients to its immunosuppressant drug Myfortic in exchange for kickbacks disguised as rebates and discounts’; Lawsuit 2 ‘Justice Department joins a qui tam, or whistleblower, lawsuit brought by a former sales rep over off-label marketing of three drugs: Lotrel and Valturna (both hypertension drugs), and the diabetes drug, Starlix’— suit joined by 29 US states and the District of Columbia.’
- 2019 [AveXis data integrity scandal]: May: FDA approved drug Zolgensma. June 28: AveXis (a Novartis company) voluntarily disclosed to the FDA that some data previously submitted to the agency as part of the Biologics License Application (BLA) package was false. August: ahead of the FDA’s investigation becoming public, “a senior manager sold stock worth almost $1 million. September 2019: FDA was still preparing its response to the scandal.
Influence Pricing
- Following 2017 inauguration of Donald Trump, Novartis paid $1.2 million to Essential Consultants, an entity owned by Michael Cohen. Cohen was paid monthly, with each payment just under $100,000. Novartis claims it paid Cohen to help it understand and influence the new administration’s approach to drug pricing and regulation.
- 2018: US Senate committee report ‘White House Access for Sale’ revealed that Novartis Ag’s relationship with Cohen was ‘longer and more detailed.’ Novartis initially stated that the relationship ceased a month after entering the $1.2 million contract with Cohen’s consulting firm since the consultants were not able to provide the information the pharmaceutical company needed. Later discovery found “that then-CEO Joseph Jimenez and Cohen communicated via email multiple times during 2017, which included ideas to lower drug prices to be discussed with the president. According to the report, several of the ideas appeared later in Trump’s drug pricing plan, released in early 2018, in which pharmaceutical companies were protected from reduced revenues.”
Other Nations v. Novartis
- 2013: two Japanese universities retracted several publications of clinical trials that purported to show that Valsartan (branded as Diovan) had cardiovascular benefits, when it was found that statistical analysis had been manipulated, and that a Novartis employee had participated in the statistical analysis without disclosing his relationship with Novartis, only disclosing his affiliation with Osaka City University, where he was a lecturer
- 2018: Novartis began being investigated by Greek authorities for allegedly bribing public officials in the 2006-2015 period.
In March of this year, dark money sources—dark because they are not
required under law to disclose their funders their funders—staged “an online
petition, a series of Facebook ads and a mass text messaging campaign,” aimed
at pushing the US president “to make hydroxychloroquine available” to treat people
who had contracted the coronavirus disease.
Politifact, connected with the nonprofit Poynter Institute, looked into
Trump’s financial connections with the drug company and found that though the
US president has no significant shares in the pharmaceutical company, the “Novartis
shares spiked briefly after Trump began touting chloroquine on March 19.” Fact
checking online allegations about the president and his associates’ financial
connections with the drug company, Politifact wrote that “available evidence
does not show any financial link between Giuliani or Trump and Novartis.”
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nother key player in the hydroxychloroquine-COVID-19 affair is Sanofi
S.A., the world’s fifth largest (rated in 2013) pharmaceutical company, by
prescription sales; its headquarters in France. Sanofi produces Plaquenil, the
brand-name form of hydroxychloroquine.
2018 total assets: €111.408 billion ($121,863,640,800), 2018 total equity €59.035 billion ($64,575,434,750), 2019 revenue €36.126 billion ($39,516,425,100)
In 2005, the United States Department of Health and Human Services
(HHS) awarded a $97 million contract to Sanofi Pasteur, the Sanofi Group’s
vaccines division.
Sanofi is also a full member of the European Federation of
Pharmaceutical Industries and Associations (EFPIA), and Pharmaceutical Research
and Manufacturers of America (PhRMA).
In 2019, PhRMA spent a record $29.3 million on lobbying and more than
70 percent of its lobbyists reportedly had ridden the revolving door in and out
of government.
What is troubling, what is dangerous and irresponsible, is that major
public figures are promoting substances for public injection about which they
are ignorant— often deliberately ignorant. In the case of the US president, he
seems to listen only to his own mutterings.
Though Hydroxychloroquine and chloroquine have been at the center of
debate in recent weeks over which drugs should be used to treat COVID-19, “neither
product has strong evidence to support use for this purpose. And small studies
reported to date have either had significant flaws or failed to demonstrate
effect. Nonetheless, the president can’t seem to stop pushing them, arguing
that patients have nothing to lose.”
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oliticians, investors, merchants, and Joe Schmoes are not scientists or medical researchers yet they
are pushing a drug that is not only untested for the condition for which they
are pushing it but is known to cause numerous serious side effects, and even
death. Some side effects are irritability, headache, weakness, hair lightening
or loss, stomach upset, nausea, dizziness, muscle pain, rash and itching; sometimes
bone marrow is affected “leading to reduced white blood cells (leukopenia) or
platelets (thrombocytopenia) and abnormal red blood cells (anemia); serious eye
damage; severe anemia resulting from the rupture of red blood cells; and a worsening
of psoriasis.
Other reports show that “Hydroxychloroquine suppresses the immune system
and should not be combined with drugs that also suppress the immune system or
live vaccines.” It also “may be secreted in [a pregnant woman’s] breast milk
and may cause side effects in the infant.”
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Too much chloroquine is poisonous” and if a person does not receive urgent
medical care, the person’s “breathing and heart can stop, or [the person] could
slip into a coma. Patients can die very quickly from chloroquine poisoning –
within a few hours.” Also “it takes the body a really long time to flush all of
the chloroquine out.” Even if the correct dosage is taken “the buildup of chloroquine
in the body over many years might still cause damage.”
Also worrisome is that some physicians reportedly “have stockpiled the
drugs for personal use, and several hospitals have adopted hydroxychloroquine
as COVID-19 standard of care” leaving “patients needing the drug for their
proven indications (malaria treatment and prevention, rheumatoid arthritis,
lupus) … to go without.”
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n her article at Conversation, Parastou Donyai concludes that though “Chloroquine
and hydroxychoroquine have been tested against the novel coronavirus both in
the lab, and in patients, none of the studies so far show convincing evidence
that chloroquine or hydroxychloroquine work against COVID-19.”
One “patient study claiming hydroxychloroquine is effective in COVID-19
didn’t use a control group, [which] means we don’t know if the results would
have been any different without giving hydroxychloroquine. For now, the US
Society of Critical Care Medicines has said there isn’t sufficient evidence to
recommend the use of chloroquine or hydroxychloroquine in critically ill adults
with COVID-19.”
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group of American physicians,
bioethicists and drug law experts, cautioned that “As public officials and
scientists rush to innovate,
no one should
overlook the critical role of strong regulatory protections in supporting our
ability to actually figure out which drugs work against COVID-19. Weakening
commitment to science and evidence during this crisis truly would be ‘a cure
worse’ than the disease.
“There is a great need for rigorously conducted clinical trials on
these products and their possible effectiveness in fighting COVID-19. But if
physicians continue prescribing them off-label, without regard for appropriate
testing, we’ll be left with anecdotes, not evidence.”
Nothing substitutes for rigorous scientific study. Irving Steinberg, in
the School of Pharmacy and Keck School
of Medicine at the University of Southern California wrote “The deliberate
steps of scientific investigation, followed by editorial scrutiny, are
guardrails [and when] these are disrupted there is a real risk that policy
organizations may make consequential mistakes in spite of good intent.…
Proper scientific
method and conduct of studies, carefully reviewed publications and cogent
post-release interpretations are necessary safeguards that ensure the best and
safest medicines are prescribed and provided.
The pressure and
desperation of the moment are forcing researchers and policymakers to be
innovative and act quickly, but what is done should stay within the guiding
concepts of medical research.
Sources
Donyai, Parastou. “Chloroquine and hydroxychloroquine: no proof these
anti-malarial drugs prevent novel coronavirus in humans.” Conversation. March
26, 2020. https://theconversation.com/chloroquine-and-hydroxychloroquine-no-proof-these-anti-malarial-drugs-prevent-novel-coronavirus-in-humans-134703
Parastou Donyai is professor and director of pharmacy
practice, University of Reading (UK)
The Guardian US. “Trump touts hydroxychloroquine as a cure for
Covid-19. Don’t believe the hype.” April 6, 2020. https://www.theguardian.com/science/2020/apr/06/coronavirus-cure-fact-check-hydroxychloroquine-trump
Politifact. “Tweet Says Rudy Giuliani ‘bought $2M in shares of
Novartis, a primary supplier of hydroxychloroquine’ in early February.” April 9, 2020. https://www.politifact.com/factchecks/2020/apr/09/tweets/fact-checking-rudy-giulianis-ties-hydroxychloroqui/
Politifact is part
of the 501(c)(3) nonprofit Poynter Institute
Wikipedia. “Hydroxychloroquine.” https://en.wikipedia.org/wiki/Hydroxychloroquine
Wikipedia. “Sanofi.” https://en.wikipedia.org/wiki/Sanofi
Wikipedia. “Novartis.” https://en.wikipedia.org/wiki/Novartis
Steinberg, Irving. “Coronavirus research done too fast is testing
publishing safeguards, bad science is getting through.” The Conversation. April
9, 2020 https://theconversation.com/coronavirus-research-done-too-fast-is-testing-publishing-safeguards-bad-science-is-getting-through-134653
Irving Steinberg is
dean for faculty, School of Pharmacy; associate professor of clinical pharmacy and
pediatrics, school of pharmacy and Keck School of Medicine, Director, Division
of Pediatric Pharmacotherapy, Department of Pediatrics at University of
Southern California.
Robertson, Christopher, Alison Bateman-House, Holly Fernandez Lynch, Keith
Joiner. “In the rush to innovate for COVID-19 drugs, sound science is still
essential.” The Conversation. Global Affairs Editor Catesby Holmes. April 8,
2020. https://theconversation.com/in-the-rush-to-innovate-for-covid-19-drugs-sound-science-is-still-essential-134638
Authors: Christopher
Robertson, professor of law, University of Arizona; Alison Bateman-House, research assistant professor, division of
medical ethics, New York University Langone Medical Center; Holly Fernandez
Lynch, assistant professor of medical ethics, University of Pennsylvania; Keith Joiner, professor of medicine, economics
and health promotions science, University of Arizona.
Monnay, Tatyana. “‘Dark money’ groups pushed Trump to back unproven
COVID-19 treatment.” OpenSecrets News. April 8, 2020. https://www.opensecrets.org/news/2020/04/dark-money-groups-pushed-trump-to-back-hydroxychloroquine/
Tatyana is a
Mid-Missouri based multimedia journalist
Voytko, Lisette. “Trump Has ‘Small,’ ‘Distant Link’ To Sanofi, French
Drugmaker Of Hydroxychloroquine.” Forbes. April 7, 2020. https://www.forbes.com/sites/lisettevoytko/2020/04/07/trump-has-small-distant-link-to-sanofi-french-drugmaker-of-hydroxychloroquine/#6fcd279e7260
Lisette Voytko is a New
York-based journalist covering breaking news at Forbes.
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