|While some people enthusiastically anticipated the release of COVID-19 vaccines, others have a much more cautious view, and a significant percentage of people state that they will not receive ANY COVID-19 vaccines. The new term for people who are concerned about vaccines is “vaccine-hesitant” (medical authorities finally acknowledged that negative name-calling was not helping their cause) and health officials are concerned about this rather large and growing group of people. Why are 35-40% of Americans (depending on the survey cited) refusing to take one of these vaccines? One commonly cited reason is the track record of the vaccine makers.|
Take Johnson & Johnson, for example. The company announced that it received Emergency Use Authorization for its single injection COVID-19 vaccine on February 27, 2021. The vaccine was developed by a subsidiary, Janssen Pharmaceutical Companies, and is available for individuals age 18 and older.
Both Johnson & Johnson and Janssen have made and distributed drugs and vaccines for a long time in the U.S., and both have paid large fines to state and federal governments. Since 2000, J&J and its subsidiaries have been charged 55 times with criminal or civil crimes and have paid a total of $4,247,381 in fines.
J&J and its subsidiaries paid over $2.2 billion in 2013 in one of the largest healthcare fraud settlements in the history of the U.S. Here are just a few of the details (from Department of Justice documents):
J&J subsidiary Janssen Pharmaceuticals marketed Risperdal, an antipsychotic drug, for unapproved uses. The company’s drug reps promoted Risperdal to doctors and other prescribers who treated elderly dementia patients, falsely claiming that the drug was effective for symptoms like anxiety, agitation, depression, hostility, and confusion.
Blatantly disregarding the fact that at the time Risperdal was only approved for the treatment of schizophrenia, Janssen created an “ElderCare sales force” to market the drug to prescribers. The company’s business plan stated that its goal was to “[m]aximize and grow Risperdal’s market leadership in geriatrics and long-term care.” Written sales aids and promotional materials were developed for reps to use when calling on doctors. The company provided incentives for off-label promotion and based bonuses for its salespeople on total sales of Risperdal in their territories, not just sales for FDA-approved uses. The company also paid kickbacks to doctors who prescribed the drug. Reps told doctors that they would receive generous speaker’s fees if they were prolific prescribers.
The company’s illegal practices resulted in the filing of false claims with federal healthcare programs. Additionally, J&J and Janssen paid kickbacks to Omnicare, Inc., the largest pharmacy specializing in dispensing drugs to nursing home patients. These kickbacks were falsely categorized as market share rebates, data-purchase fees, grants, and educational funding. The kickbacks were designed to incentivize Omnicare’s pharmacists to promote Risperdal to nursing home patients.
Janssen was warned by FDA officials on several occasions that claims that Risperdal was safe and effective were misleading. FDA officials told Janssen executives that behavioral problems in elderly dementia patients were usually not due to psychotic disorders and were more likely “appropriate responses to the deplorable conditions under which some demented patients are housed…”
According to the Justice Department, both J&J and Janssen knew that Risperdal increased the risk of stroke in the elderly. The companies manipulated data in order to cover this up. When a J&J study showed that taking Risperdal significantly increased the risk of stroke and other adverse events, Janssen executives combined the data with other studies to make it look like the drug actually lowered the risk.
A second study confirmed the risk of Risperdal for elderly patients. When it looked like the company was not going to publish the data, a physician involved with the study advised Janssen that “[a]t this point, so long after [the study] has been completed…we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings.”
Another complication of Risperdal was increased risk of diabetes. First, the company outright lied, promoting Risperdal as “uncompromised by safety concerns (does not cause diabetes).” When confronted with research showing that Risperdal increased the risk of diabetes, just like other antipsychotics, the company hired experts to re-analyze the study and to publish articles stating that Risperdal actually lowered the risk of diabetes.
The company’s behavior seems particularly egregious since the targeted population for the unlawful prescribing of the drug were some of the most vulnerable people. In addition to elderly nursing home patients, Janssen promoted the drug to children and adults who had developmental disabilities. Records show that both J&J and Janssen executives knew that there were several risks associated with prescribing Risperdal to children. These included the risk of elevated levels of prolactin, a hormone that stimulates breast development and milk production. Nonetheless, Janssen’s “Key Base Business Goals” included growing and protecting market share for children and adolescents for Risperdal. Reps were instructed to call on psychiatrists and facilities that treated children, and to promote Risperdal as a safe and effective drug for children with attention deficit disorder, oppositional defiant disorder, obsessive-compulsive disorder, and autism. The company was warned repeatedly by FDA not to promote the drug for use in children.
It is important to note that there are other side effects of Risperdal that are quite concerning, including tardive dyskinesia, fatigue, drowsiness, fever, weight gain, dry mouth, restlessness, anxiety, insomnia, vomiting, stomach pain, constipation, cough, sore throat, and skin rash.
Drug companies make so much money that multi-billion-dollar fines for criminal behavior are just a cost of doing business. Thus it is not surprising that in 2019, an Oklahoma judge ruled that J&J had intentionally minimized the risks and misrepresented the benefits of opioid drugs. The judge wrote that J&J had used “false, misleading and dangerous marketing campaigns” that “caused exponentially increasing rates of addiction, overdose deaths, and babies born exposed to opioids.” The company was ordered to pay the state $572 million.
I’ve presented here just a couple of the episodes in which J&J and/or its subsidiaries were caught committing criminal fraud and engaging in activities that resulted in considerable harm and even death for large numbers of people. The company is a serial offender, yet the federal government continues to allow it to do business in the U.S., and routinely approves new products submitted by the company, such as its new COVID-19 vaccine.
I can’t fathom that anyone who knows about J&J and its prior bad acts would agree to any medical intervention produced and marketed by it. I certainly won’t.
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