Pharma Steals Our Tax Dollar

The 21 st Century Cures Act was passed by Congress and signed into law by President Obama in December of 2016. The bill previously stalled in the Senate in 2015 until the end of November of 2016, when it was pushed through the Senate with a 94-5 vote. This act included 1,000 pages that tout some impressive sounding rhetoric, pledging a $1.8 billion investment in cancer research and another $1 billion to fight the abuse of opioids, heroin and other addictive drugs. It also pledges $6.3 billion in spending and will streamline drug and medical device approvals by the FDA over the next decade.

It’s just too bad that the vaccine and medical device manufacturers and lobbyists are the big beneficiaries of the Act, as was reported in the International Business Times (IBT). This bill was conceived to boost research, but the law has been revised and tweaked many times to build bipartisan support. The pro-industry groups have used the bill as a vehicle to achieve their legislative agenda of reducing the regulatory burden of bringing products to market.

According to Dr. Michael Carome, director of the consumer advocacy group Public Citizen’s Health Research Group, all sorts of goodies were added to the Act by courtesy of medical device and pharmaceutical companies. To summarize, the Act makes it easier for these industries to bring their products to market by loosening the testing requirements. Now they will no longer require drug companies to conduct large, randomized and controlled human clinical trials. These are the trials that are considered to be the gold standard for proving pharmaceutical product safety, including approval to sell a drug to treat more than one condition. Observational data could be regarded as sufficient to “prove” the safety and approve the drug for multiple uses. This also allows industry to submit only summaries of data to the FDA when asking for approval and the drug companies will be allowed to team up with insurance companies to promote off label uses for their drugs.

Experimental drugs and vaccines fast-tracked to the market at the expense of public health. Some of the vaccine mandates are added for children to attend school and some for adults to work in the health care and daycare professions. The Act weakens informed consent protections for those taking part in experimental vaccine clinical trials and allows the use of surrogate endpoints to evaluable vaccine effectiveness. This act is referred to as “a wolf in sheep’s clothing” and NVIC called for a presidential veto of the legislation passed by Congress in order to protect public health. Congress has allowed the pharmaceutical industry to further co-opt the federal vaccine licensing and policymaking process.

Not all of the Senate agreed with the act and openly opposed to the legislation. One provision in the Act would allow antibiotics to be approved even if they’d only been tested in small clinical trials on a limited number of patients. There could be risks that are not detected during small studies of the drugs and could lead to inappropriate use in a large number of people. The Act was largely written by the pharmaceutical and health care industries. Cases of dying children and their families were even used to promote the bill, suggesting that a new law is somehow going to inspire researchers to suddenly cure their diseases. It’s unfortunate that the drug companies and device makers will reap the benefits with increased profits by putting their products on the market with less oversight. Again, the public will pay a high price for the introduction of drugs that have not been properly tested with clinical trials. All for the power of the big pharmas.

Dr Fredda Branyon