Drug research is both scientifically difficult and financially taxing. It takes more than a decade and costs well over $2 billion to develop just one FDA-approved drug.
It is important to note that the FDA does not develop or test drugs. Their job is to review the results of the drug maker’s laboratory, animal and human clinical testing to determine if the drug or vaccine is safe and effective. When new drugs are submitted everything must be presented, from preclinical data to Phase 3 trial data, proposed labeling, safety updates, drug abuse info, patent information, data from studies conducted outside of the US, up to directions for use.
At the heart of the FDA’s medical product evaluation decision is a judgment about whether a new product’s benefits will outweigh its risks. However, the FDA is allowed to authorize a product for emergency use to treat serious, life-threatening conditions – which brings us to the emergency use of the COVID shots produced by Moderna/NH, Pfizer/BioNTech, Astra Zeneca, and Johnson and Johnson. According to the FDA web site, these emergency use shots are NOW in Phase 3 trials.
On September 1, 2021, the CDC, in response to accusations that COVID isn’t a true vaccine, altered the decade’s long definition of such as a product derived from inactive toxins or immunologically active markers extracted or copied from microorganisms, to a “product” that stimulates a person’s immune system to produce immunity to a specific disease. However, changing the definition to fit a product doesn’t alter the truth that the shot is experimental messenger RNA gene therapy, made of synthesized genetic material that instructs cells in your body to produce an antigenic substance such as viral protein snippets or fragments which stimulates your immune system to attack if the designated virus tries to invade the body.
Through their power of emergency use, the FDA granted special permission to Pfizer, Moderna and Johnson & Johnson to expedite the development phases of the Covid shot. Moderna, for example, completed phase 1 in just 63 days. All three manufacturers were allowed to conduct human trials prior to, or at the same time, as animal trials, while skipping any research regarding the long term health risks, and then given immunity for any medical damage or death cause by the shot.
The immunity from injury truly bothers me because the manufacturers of these shots don’t have the greatest safety record, or ethical behavior.
Pfizer and Johnson & Johnson plead guilty to “misbranding with the intent to defraud” and “paying kickbacks to induce” providers to prescribe their drugs, and were fined $2.3 billion in 2009 and $2.2 billion in 2013, respectively. A few years later Pfizer settled a lawsuit for “manipulating studies” and “suppressing negative finds”.
Moderna, who has never developed an approved drug, had one of their board members, Moncef Slaoui, placed in charge of Operation Warp Speed. While Slaoui divested his shares in Moderna stock at a potential gain of $10 million, questions were raised about his neutrality in judging vaccine candidates. Since the start of the pandemic, Moderna has received over $6 billion from the government.
AstraZeneca, whose COVID shot is not used in the US, was forced to settle a whistleblower suit for “misleading marketing tactics” for their drug Crestor to the tune of $110 million. They settled a suit with the DOJ for $7.9 million for “kickbacks” to pharmacies to push Nexium; were ordered by DOJ to pay $46.5 million for underpayment of rebates owed under the Medicaid Drug Rebate Program; $520 million for off-label drug marketing; $103 million for overcharging Medicare, Medicaid and private insurance companies; $68.5 million to settle improper marketing of their antipsychotic drug Seroquel, to name but a few.
GlaxoSmithKline (GSK), whose COVID shot is no longer used in the U.S. pled guilty and was fined $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. They previously pled guilty to charges relating to their manufacture and distribution of certain “adulterated” drugs made at a Puerto Rico facility that included a criminal fine and forfeiture totaling $150 million and civil settlement for $600 million. They have also been fined $105 million for unlawfully promoting Advair, Paxil and Wellbutrin and $6.5 million for false claims that Benefiber was all natural.
Johnson & Johnson has been named in hundreds of thousands of lawsuits over the safety of their products, agreeing to pay $8 billion for lawsuits against its schizophrenia drug, Risperdal; $2.2 billion to resolve criminal and civil liability relating to its drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe by the FDA; and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. In addition to settlements reach in the baby powder law suits, they agreed to pay $2.4 billion for suits against their baby wash and $20 million for a transvaginal mesh lawsuit, to name but a few.
Almost half of new drug approvals have been based on only one pivotal clinical trial instead of the two or more that was once the norm. In 2018 the median review time was 10.1 months compared with 2.8 years for standard and priority applications from 1986 to 1992 when Congress passed the Prescription Drug User Fee Act which allowed manufacturers to pay the FDA “fees” to fund the drug review process.
Those “fees” jumped from a mere $29 million in 1993 to a whopping $908 million by 2018, an amount close to 80% of the money spent on employee salaries for drug reviewers.
Congress’s attempt to justify drug manufacturers paying the FDA “fees” to hasten the approval of drugs has created a culture where the primary client is no longer viewed as the patient – but as the industry.
Source: FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, by Sydney Lupkin, NPR; Three reasons why the COVID-19 vaccine is not a vaccine by James Bailey, Z-3 News; Prescription Drug User Fee Amendments , US Food and Drug Administration; One-Third Of New Drugs Had Safety Problems After FDA Approval, CPR News; A Legacy of Corruption in the FDA and Big Pharma, by Liam Cosgrove, Mises Inst.
