Sometime next month the pharmaceutical, medical device and consumer goods giant, Johnson & Johnson, plans to start human clinical trials for its COVID-19 vaccine.
On June 20, J & J announced in a press release that one of its 250 subsidiaries, Janssen Pharmaceutical, “has accelerated the initiation of the Phase 1/2a first-in-human clinical trial of its investigational SARS-CoV-2 vaccine.”
Originally scheduled to begin in September, the trial is expected to begin in the second half of July.
“Our goal is to ensure we can deliver a vaccine to the world and protect people everywhere from this pandemic,” said Paul Stoffels, M.D., J & J Vice Chairman of the Executive Committee and Chief Scientific Officer, in the press release.
But considering J & J’s track record with: cancer-causing asbestos contamination in its iconic talc baby powder, resulting in tens of thousands of lawsuits; its baby shampoo, which contained another carcinogen, formaldehyde; the $344 million verdict over deceptive pelvic mesh marketing practices; and its role in the opioid epidemic, producing narcotics and selling them to OxyContin manufacturer, Purdue Pharma, should the public trust the company with producing a safe and effective vaccine for the highly-contagious coronavirus?
Asbestos Cover Up
Last month, J & J announced it would stop selling its talc-based baby powder in North America. The company reached the decision because of declining talc sales and pending lawsuits claiming that the talc contains asbestos, which can cause both mesothelioma, a cancer in the lining of the lungs and/or other organs, and ovarian cancer, if the powder is used in the genital area over many years. Lawsuits over the baby powder are nearly 20,000 in number.
In one case alone, from 2018, J & J was ordered to pay nearly $4.7 billion to 22 women and their families. The women claimed that long-term use of the baby powder contributed to their ovarian cancer. Earlier today, an appeals court upheld the verdict; the damage award was reduced to $2.1 billion. Out of the 22 women, half of them did not live to see the ruling.
J & J is expected to pursue further review of the case by the Supreme Court of Missouri, where the jury verdict was awarded.
In 2019, a woman who used the baby powder for several years and developed mesothelioma was awarded $29 million. The company has also appealed that decision.
According to a March 9 report by the Food & Drug Administration (FDA) on asbestos in consumer goods, federal agencies and the World Health Organization (WHO) maintain that there is no known safe level of asbestos exposure.
J & J maintains that its talc products are thoroughly tested and pose no danger.
However, a Reuters investigation claims that since as early as 1971, J & J was aware that the talc mined for use in its baby powder may have tested for at least small amounts of asbestos, yet the company failed to disclose the contamination to regulators or the public.
Fueling The Opioid Crisis
In 2018, 67,000 people died from drug overdoses. Opioid drugs accounted for 70% of those deaths (nearly 47,000). Oklahoma was the first state to take J & J to court. According to STAT News, Oklahoma alleged that the company created a public nuisance by “launching an aggressive and misleading marketing campaign that overstated how effective the drugs were for treating chronic pain and understated the risk of addiction.” Oklahoma won the case and was awarded $465 million.
During the case, the Oklahoma Attorney General Mike Hunter called J & J a “kingpin company,” motivated by greed and pointed to the company’s role in producing the raw opium that was used to develop synthetic opiates such as OxyContin.
Reporting by Mother Jones contends that J & J dominated the opioid market for years, targeting high-volume prescribers, paying key opinion leaders, funding pain patient advocacy groups, and generally promoting the idea that opioids were safe and effective for chronic pain.
J & J “Put Profits Ahead of the Health of Millions of Women”
In 2016, the California Department of Justice sued J & J because the company neglected to inform both patients and doctors of possible severe complications from surgically-implanted pelvic mesh. The lawsuit alleged that the company “misrepresented the frequency and severity of risks the products posed.”
Earlier this year, J & J was ordered to pay $344 million in penalties because of false and deceptive marketing. In a news release, California Attorney General Xavier Becerra said, “Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices. It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies.”
Becerra added, “Johnson & Johnson knew the danger of its mesh products but put profits ahead of the health of millions of women.”
Not Approved As Safe And Effective By The FDA
Last year, two random batches of J & J’s Baby Shampoo sold in the Indian state of Rajathastan, were found to contain traces of formaldehyde, a known carcinogen. A report by NDTV, an Indian media outlet, quotes the state’s Drug Controller, who said, “There is a presence of formaldehyde … Johnson & Johnson is now claiming they have not used formaldehyde in the product, but it’s showing up in the test.”
In 2013, according to a news release from the U.S. Department of Justice, J & J was set to pay $2.2 billion “to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider.”
The release describes the resolution as one of the largest health care fraud settlements in U.S. history.
Then U.S. Attorney General, Eric Holder, said in the release, “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder.“
In addition to the above lawsuits, the company faces litigation in thousands of cases over other medical devices and pharmaceuticals, including: DePuy Hip Resurfacing System; Xarelto; and Pinnacle Acetabular Cup.
Considering that J & J has over 250 subsidiary companies operating in 60 countries, one may expect occasional problems with some of its product in its portfolio. However, there seems to be a pattern of, at the very least, deceptive business practices within the conglomerate’s modus operandi.
J & J In The Race To Fast-Track A COVID-19 Vaccine
According to J & J’s news release from June 20, the company is in discussions with the National Institutes of Allergy and Infectious Diseases “with the objective to start the Phase 3 SARS-CoV-2 vaccine … clinical trial ahead of its original schedule, pending outcome of Phase 1 studies and approval of regulators.”
The company adds in the release that it is “Committed to the goal of supplying more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.”
Considering that a COVID-19 vaccine will skip a vital step in testing—showing that the drug is safe and effective on animals—can J & J be trusted to develop a safe and effective vaccine for the novel coronavirus?
With normal vaccine testing, it can take at least five years to demonstrate safety and efficacy. Will the test adversely affect the 1,045 healthy adults set to receive the experimental vaccine? Will the vaccine have any long-term implications on human health for the one billion-plus people who may ultimately receive it?
Only time will tell. One thing is for certain, however. J & J will not have to worry about pending litigation over its forthcoming vaccine. Drug makers are not held liable for damages arising from a vaccine-related injury or death.