Merck’s Deadly Vioxx Playbook, Redux: A Debunked Smear Campaign Against Its Competing Drug—the FDA-approved, Nobel prize-honored IvermectinBy Dr. David E. Scheim
Global Research, September 09, 2021
TrialSiteNews 7 September 2021
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Latest news reports of a cluster of ivermectin overdoses in Oklahoma were debunked by the hospital. Not one such case. The doctor who fabricated the story hadn’t work there in two months.
On February 4, 2021, Merck, which is readying release of its new COVID-19 treatment drug, molnupiravir, issued a press release about that new drug’s competition, ivermectin.1 Merck itself had developed ivermectin, now off-patent, for human use, securing FDA approval in 1987, and distributed most of its 3.7 billion doses safely used worldwide since.2-4 It was thus curious that Merck’s press release about use of ivermectin for COVID expressed “a concerning lack of safety data in the majority of studies.”1
Recently, many news reports5-8 picked up on Merck’s theme, lambasting the use of a dangerous horse de- wormer by gullible consumers. The most recent were by the BBC,9 Rolling Stone,10 The Guardian,11 MSN12 and others, about Oklahoma hospital facilities being strained with ivermectin overdoses, delaying other emergency care. The hospital system in question debunked the story, noting that it had not one case of ivermectin overdosing and that the doctor who fabricated the story hadn’t worked there in two months.13,14
These false alarms about ivermectin safety, echoing Merck’s, are scientific nonsense. Ivermectin is FDA approved for human use,4 its discovery honored with the 2015 Nobel Prize for medicine, for “improving the health and wellbeing of millions,” with “limited side effects.”15 One of the safest modern drugs, it is well tolerated even at very high doses (details below). By a quirk of molecular biology, ivermectin binds to SARS-CoV-2 spike protein and obstructs the morbidity of the virus.16-18 It thereby also obstructs Merck’s anticipated billions in revenues from its new COVID entry. As to Merck’s past playbook for such obstacles, consider its $410 million disinformation campaign for its deadly drug Vioxx,19 withdrawn in 2004.
“Dodge Ball Vioxx.” In a scathing critique of Merck’s duplicitous promotion of Vioxx,20 Richard Horton, the editor-in-chief of Lancet, noted how Merck prepared a sales presentation, entitled “Dodge Ball Vioxx,”21 with instructions for dodging awkward inquiries from physicians. To the question, “I am concerned about the cardiovascular effects of Vioxx?” the answer that Merck instructed was: “DODGE!”
“Neutralize,” “discredit,” “destroy.” Merck knew early of Vioxx’s cardiovascular risks, which resulted in up to 139,000 heart attacks and strokes, 30-40% of them likely fatal.22,23 Merck not only concealed some such deaths,22,24but it systematically attacked those who warned of these fatal risks. It created a spreadsheet that named Vioxx critics and noted plans for each, including “neutralize,” “neutralized” or “discredit.”25,26 Merck also listed its staff assigned to each critic—an entire “task force” to one. On October 15, 2001, one Merck executive emailed another: “We may need to seek them out and destroy them where they live.”1,26
Regulatory Capture.27 Horton, the Lancet editor, noted the role of the FDA in enabling Merck’s Vioxx scandal. The FDA saw “the pharmaceutical industry as its customer,” not the US public.20 When an associate FDA director, David Graham, MD, blew the whistle on Vioxx’s deadly record, he was subjected to threats, abuse, and lies orchestrated by his FDA superiors.28 The FDA Commissioner who approved Vioxx resigned and then went on to become senior counsel for Merck’s PR firm.28 Horton summarized, “with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest.”20
Good journalists get extremely angry when they’ve been had. The major media do not generally spew scientific nonsense. It would appear to take a budget on the order of the $410 million for Merck’s prior Vioxx promotion19 to get incisive, respected journalists such as Paul Waldman of the Washington Post29 and Rachel Maddow of MSNBC30 to be duped into echoing Merck’s February PR claim that ivermectin is unsafe. Yet good journalists get extremely angry when they’ve been had. Any newsroom can fact check that ivermectin is FDA approved for human use, Nobel prize-honored, developed by Merck, now molnupiravir’s competitor, and extremely safe. Such brazen overreach can easily backfire into focus on Merck’s prior drug misinformation campaign. It takes rare PR brilliance for Merck, with its new drug release pending, to prompt a searing revisit of its past tactics in promoting its deadly drug, Vioxx.
On the science behind ivermectin and COVID-19, including clinical, animal, and molecular studies, see this recently published review.18 Its lead author is a prominent clinical researcher at Yale. Two coauthors are in the line of the only two Nobel prize-honored treatment breakthroughs for infectious diseases since the one for streptomycin in 1952. Notably, coauthor Thomas Borody in 1990 published the first clinical trial for the cure for H. pylori (peptic ulcers).31 That cure consisted of three repurposed inexpensive drugs: two antibiotics and bismuth.18 It was adopted immediately in Australia, in 1990, saving an estimated 18,000 lives.32 A decade later, after the patents for the billion dollar palliative drugs, Tagamet and Zantac, expired, that cure became the standard of care for peptic ulcers in the rest of the world.18
Ivermectin safety. Ivermectin is well tolerated even at ten times the standard dose of 200 μg/kg,33,34 and at high doses, in particular, for COVID-19 treatment.35,36 Cancer patients who took ivermectin at five times that standard dose daily for up to 180 consecutive days had no serious adverse effects from it, in experimental protocols with harsh additional drugs.37 Of 19 patients who took extreme overdoses up to 1,000-fold that standard dose of either ivermectin or the closely related abamectin, all using veterinary forms, only one 72-year-old male who took 440 times the standard dose died.38
As noted, ivermectin is FDA approved for human use,4 and as is the case with all but one of current COVID- 19 treatment drugs, is used off-label for COVID treatment. More generally, 21% of all drug prescriptions in the US are off-label.39,40Since many news reports have hopelessly confounded the human and veterinary forms of ivermectin, this clarification is useful. Only human drug forms of ivermectin can be recommended for human use. Products for external animal use generally contain ingredients unfit for human consumption. The injectable liquids typically contain glycerol formal, which tastes nasty but is not toxic; these can be overdosed if not dispensed carefully. Most COVID-19 patients facing life-and-death decisions without access to the human drug have used the 1.87% horse paste in a squeeze tube for oral animal ingestion.
Do no harm. It should be noted that in the US, the standard treatment recommendation for the early stage of COVID is palliative, to take Tylenol.41 (Note, incidentally, that in the US, acetaminophen (Tylenol) overdoses account for more than 100,000 calls to poison control centers, 56,000 emergency room visits and an estimated 458 deaths from acute liver failure each year.42) Therefore, per the Hippocratic oath of do no harm, given the safety of ivermectin and solid indications of clinical efficacy against COVID-19,18 it is unconscionable to place obstacles to such clinical use. It is clear that the quest for profits has at times subverted public health, for example, with Merck’s Vioxx, and with the ten-year delay in the deployment of the cure for peptic ulcers until the patents for two billion-dollar drugs expired. It behooves all parties to study the science and refrain from and rectify misleading, negative reports about ivermectin.
Below are links to key documents, including internal files from Merck and publications from major scientific journals as relate to the above.
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