More urgent news not reported by the New York Times, which is too busy stoking panic,and trying to reconcile us all to staying indoors forever. Of course, it’s possible that someonethere—or someone at some other news outlet—is now investigating how and why Johnson and Johnson got that contract; so maybe we’ll see something on it by and by. Or maybe not. So please send this far and wide.
From John Gilmore, who heads the Autism Action network:
The company selected by the federal government to fast-track develop a coronavirus vaccine is the subject of billions in court settlements and judgments, in the last year alone, for being a key operator in the opioid epidemic among other criminal activities, and it has no track record in creating or manufacturing vaccines. And the federal agency that issued the contract is part of the same federal department that will oversee every aspect of the vaccine’s evaluation, licensing, and distribution. Johnson and Johnson (J&J), and it subsidiary Janssen Pharmaceutica, the enormous global medical products firm, was awarded a $450 million contract on Monday by the US federal government. J&J will be committing its own resources to bring the total value of the project to more than $1 billion. Trials of the vaccine are expected to begin in September and production for general use is expected to begin in early 2021. Normally testing and safety analysis of a new vaccine in the US takes 5 to 7 years. J&J will build a new vaccine factory in the US with a goal of producing a billion doses annually beginning next year. Yet no vaccine licensed for use in the US was developed or is manufactured by J&J. And the federal government is already assuming that the vaccine will be safe and effective. Expedited development of vaccines in the US has a poor track record. In 1976 a vaccine was quickly brought to market for an outbreak of swine flu but just as quickly withdrawn when multiple cases of Guillain Barre Syndrome were caused. And the H1N1 virus rushed to market in 2009 also caused significant numbers of Guillain Barre Syndrome among other side effects. It is hard to imagine any company could be facing more lawsuits than J&J. According to the Wall Street journal J&J had 103,000 legal claims by companies, individuals, states, cities, counties and other legal entities in the middle of last year. J&J have had legal judgments and settlements of more than $10 billion just in the previous two years. Last fall an Oklahoma Court fined J&J $465 million for its role in the opioid epidemic in that state. Judge Thad Balkman said J&J had promulgated “false, misleading, and dangerous marketing campaigns” that had “caused exponentially increasing rates of addiction, overdose, deaths” and babies born exposed to opioids. J&J also agreed to a $20 million settlement for damages associated with opioids in two Ohio counties. Thousands of other suits are pending across the US. J&J was a major player contracting with poppy growers in Australia to supply 60% of the opiate ingredients used for drugs like oxycodone. It also produced an opioid pill the company sold in 2015, and Duragesic, a fentanyl patch. In a statement released with the announcement of a lawsuit in the spring of 2019 against J&J and other opioid manufacturers, New York Attorney General Leticia James said, “We found that pharmaceutical manufacturers and distributors engaged in years of deceptive marketing about the risks of opioids and failed to exercise their basic duty to report suspicious behavior, leading to the crisis we are living with today.” J&J’s legal problems go far beyond opioids. Last month a New Jersey court ordered J&J to pay $186 million in four cases where plaintiffs claimed using J&J talcum powder that contained asbestos caused ovarian cancer. Lawyers for the plaintiffs established that J&J knew the powder contained asbestos but denied that fact publicly. The judgment follows multiple other settlements and awards to plaintiffs including a $4.7 billion judgment by Missouri court in 2018. J&J also agreed in October of 2019 to a $117 million settlement with 41 states and the District of Columbia over false claims made in the marketing of a pelvic mesh product. Suits are still outstanding with 4 other states. A Philadelphia jury awarded $8 billion in October 2019 to settle 10,000 lawsuits against J&J for side effects, including gynecomastia (males growing female breasts), associated with its Risperdal product. Risperdal was licensed as a n anti-psychotic marketed extensively in the early 2000s to treat “irritability” associated with autism, and was the first drug licensed to address autism symptoms. Earlier in 2019 J&J reached a $775 million settlement in 25,000 lawsuits alleging patients were not adequately warned about the risks of life-threatening complications of their Xarelto blood thinner. All safety and efficacy testing for vaccines is performed by the company seeking to license the product, and then submitted for evaluation to various agencies within the Federal Department of Health and Human Services (HHS). The process assumes the applicant will supply accurate information to the regulatory agencies, yet with J&J the applicant has a very long and well-established record of deception and lawbreaking. The process also rests on the assumption that the regulatory agencies will be a disinterested parties in the outcome of the application process, yet the federal government is already planning on producing a billion vaccines within months, and every aspect of the development, evaluation and marketing of the vaccine will be under the jurisdiction of HHS. The contract will be administered by the Biological Advanced Research Development Authority (BARDA), a unit of HHS. Safety and efficacy evaluation of the new vaccine will be the responsibility of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) which are also units within HHS. The CDC is also the single largest buyer of vaccines in the US, primarily for the Vaccines for Children Program. Any injuries that may occur from the use of a vaccine would be adjudicated by the Health Resources and Services Administration, which is also a unit within HHS. Please share this message with friends and family, and please post to social media while we still can.