Ezekiel J. Emanuel is an oncologist, medical ethicist and professor at the University of Pennsylvania. Paul Friedrichs was the inaugural director of the White House Office of Pandemic Preparedness and Response Policy.
Health Secretary Robert F. Kennedy Jr. repeatedly assured Congress and Americans that he would not “take vaccines away from anybody.”
While technically true, so far, he has devised an underhanded way to accomplish exactly that by removing liability protections from vaccine manufacturers and thus eliminating any profitability from vaccine sales and induce them to stop producing vaccines. This will also slow or prevent the development of new vaccines against deadly diseases.
Economics makes Americans’ access to vaccines very fragile. Research trials to prove that vaccines are safe and effective must enroll tens of thousands of patients. Consequently, they take a long time and are very expensive. Yet, to ensure access to all Americans, particularly 70.4 million children, vaccines must be cheap. Thus, the profit margins for manufacturers are very small. Studies have shown that many physicians barely break even from administering vaccines. To ensure both the availability of vaccines for all Americans and sufficient and predictable demand for manufacturers, the federal government purchases vaccines through the Vaccines for Children Program and provides them free to more than half of all U.S. children through Medicaid, Children’s Health Insurance Program and similar programs to help the uninsured, underinsured and Native Americans.
The economics only work because of the National Vaccine Injury Compensation Program. All medical procedures and treatments carry some risks, but fortunately, we have decades of data from the United States and other countries showing that the adverse effects and risks from vaccines, while not zero, have been remarkably low. By 1986, lawsuits drove many commercial manufacturers to stop making vaccines, creating vaccines shortages and reduced vaccination rates.
To ensure vaccine availability, President Ronald Reagan signed the law creating the VICP. Manufacturers pay 75 cents from each vaccine dose they manufacture (or sell) into a pool which is used to compensate anyone who was injured by a vaccination, without the need for lengthy lawsuits. Since the VICP was established, about one vaccination recipient has received compensation for every 1 million vaccine doses administered.
The VICP is a win-win-win-win arrangement: Injured patients are fairly compensated without expensive, lengthy, and uncertain trials and legal fees. Manufacturers keep producing low-cost vaccines and developing new ones, and the government pays nothing. Meanwhile, the American public stays healthy.
Kennedy understands he can take vaccines away from Americans if he makes vaccines unprofitable. If the VICP is overwhelmed by too many claims and goes bankrupt, manufacturers become financially liable. Facing new risks of lengthy and expensive litigation, they will stop selling vaccines in the U.S.
How can Kennedy overwhelm the vaccine compensation scheme? By claiming vaccines cause autism and other complications. Numerous studies involving 1.8 million children in multiple countries have definitively shown no association between vaccines and autism. Despite this overwhelming data, Kennedy forced the Centers for Disease Control and Prevention to change its website to say “the claim ‘vaccines do not cause autism’ is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism.” This is the latest step toward adopting a claim that “vaccines can cause autism” and allow parents of autistic children to seek compensation from the VICP.
If this change happens, over 100,000 children who are diagnosed with autism each year could claim compensation from the VICP. And thanks to Kennedy and the Children’s Health Defense he founded, somewhere between 25 and 50 percent of parents with autistic children believe vaccines caused their child’s condition. The expected groundswell of compensation claims and lawsuits will easily bankrupt the vaccine compensation pool, while enriching lawyers like Kennedy.
It would also hurt the development of new vaccines for diseases such as Lyme disease, an improved vaccine for tuberculosis or a vaccine for some cancers, all of which are under development now. Without a viable and predictable market to purchase vaccines, underpinned by the VICP’s liability protection, the expensive and lengthy research on vaccines for these and other diseases won’t happen in America, and vaccines won’t be sold here.
A year ago this seemed far-fetched, but no longer. Kennedy has repeatedly done the unthinkable in his march to discredit vaccines. He has packed the Advisory Committee for Immunization Practices with vaccine skeptics; fired CDC staff, including Director Susan Monarez; put vaccine skeptics in positions at the FDA to make it harder for vaccines to be approved; and changed government statements to emphasize spurious vaccine risks unsupported by rigorous research.
Sen. Bill Cassidy (R-Louisiana) and other Republicans need to do more than just tweet their opposition to Kennedy’s actions. They must hold hearings on vaccine safety, insist only credible experts serve on ACIP, demand Kennedy’s resignation and enact legislation to protect the vaccine compensation scheme from autism related claims. Only then will American children and adults be safe from easily preventable infectious diseases.
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