This is very bad news for those who are advocating for safer pharmaceuticals. The 21st Century Cures Act is a thinly veiled give-away to giant pharmaceutical companies, and it decreases prescription drug safety measures at a time when prescription drugs are the 4th leading cause of death in the United States. It is a huge step backward in public safety and diminishes patient protection from dangerous drugs. The so-called “Cures Act” will make the already inadequate FDA completely inept, and the FDA stamp of approval will no longer have any safety implications.
The 21st Century Cures Act has duped people not only with its Orwellian name, but also with enticing bits that make the dismantling of long-standing patient safety protocols seem okay. Sure, the “Cures Act” includes a minor increase in funding for the NIH, and a couple cut-outs for rare disease research, but are those things an adequate reward for the demolition of pharmaceutical safety standards? I certainly don’t think so.
Here are some awful things about the 21st Century Cures Act:
Health Outcomes Will Matter Less
The 21st Century Cures Act will allow pharmaceutical drug approval to be based on biomarkers and surrogate measures rather than health outcomes.
This means that pharmaceutical drugs and medical devices can be approved by the FDA based on anecdotal evidence that they should save lives rather than actual evidence that they DO save lives. This is already happening to some extent. We see statin drugs being prescribed as heart-attack and death prevention, even though they (and their effect of lowering cholesterol) have never been shown to decrease heart attacks or death among the female half of the population. A more dramatic example is noted in a New England Journal of Medicine (NEJM) article, “The 21st Century Cures Act — Will It Take Us Back in Time?:
”In 2013, patients began to receive a new drug for tuberculosis approved on the basis of a randomized trial relying on a surrogate measure of bacterial counts in the sputum — even though patients given the drug in that trial had a death rate four times that in the comparison group, mostly from tuberculosis.”
The drug that worked on the biomarker actually made people more likely to die. That’s not what we want from our pharmaceuticals. The 21st Century Cures Act will further encourage the use of anecdotal evidence, observational data, biomarkers, and surrogate measures for pharmaceutical drug approval. It’s a move in precisely the wrong direction.
Massachusetts Senator Elizabeth Warren noted in a late-November speech on the Senate floor that, “Pushing treatments without scientific evidence that they work is fraud—fraud that can hurt people.” Indeed. And the 21st Century Cures Act encourages that kind of fraud.
The Cures Act Will Rush Drugs to the Market
The 21st Century Cures Act will rush pharmaceutical drugs to market, and diminish requirements for phase III testing at a time when pharmaceutical safety regulation is so lax that hundreds of thousands of people are being maimed and killed by medical mistakes annually. It will make it easier for dangerous drugs to enter the market. As any patient advocate trying to get a dangerous drug removed from the market (or restricted) will tell you, it’s very difficult to get dangerous drugs taken off the market once they are approved. Rather than removing dangerous drugs from the market, the FDA prefers to simply increase the size of drug warning labels (which doesn’t actually make drugs any safer).
FDA Approval Will Become Meaningless
The 21st Century Cures Act will diminish the ability of patients and physicians alike to trust that a pharmaceutical drug is safe based on it being “FDA approved.” In the STAT article, “21st Century Cures Act will distort the meaning of ‘FDA approved’” it is noted that,
“These provisions would unravel the FDA, turning it from the treatment watchdog it is today into a puppet of the pharmaceutical and medical device industry. If the 21st Century Cures Act is passed as written, clinicians could be given potentially deadly drugs and devices to prescribe to their patients, blessed by this new version of FDA approval.”
If we can’t trust the FDA to make sure that drugs are safe and effective, who can we trust? The pharmaceutical companies are profit-driven and dishonest–they certainly aren’t going to tell patients if a drug isn’t safe. Doctors are too busy to read current drug warning labels, much less able to do research on all new drugs that enter the market. The FDA has a valuable role to play–ensuring pharmaceutical drug safety and efficacy. Patient frustration stems from their inability and/or unwillingness to adequately protect patients, and the 21st Century Cures Act further diminishes the capacity of the FDA.
The Cures Act Will Hide Bribery
The 21st Century Cures Act will also exempt physicians from disclosing financial relationships with pharmaceutical companies, reversing a current transparency requirement that helps patients stay informed about their physicians’ financial conflicts of interest. If the Act passes as-is, we will no longer have information about physician conflicts of interest available to us. In the video below, Senator Warren calls these conflicts of interest exactly what they are: BRIBES. The 21st Century Cures Act will encourage the bribing of our trusted physicians by big pharma.
Other Problems with the 21st Century Cures Act
In her speech below, Senator Warren notes that there are additional provisions in the 21st Century Cures Act that cut Medicare funding, take money away from the Affordable Care Act, take healthcare funds away from Puerto Rico, and make it harder for people with disabilities to get Medicaid services.
Failure to Learn from the Past
People in the US like to pat ourselves on the back for avoiding the Thalidomide disaster, forgetting that we didn’t avoid the DES disaster or the antibiotic resistance disaster, and that we lead the world in chronic, mysterious illnesses. We were only able to avoid having a generation of babies who had been maimed by Thalidomide because we had a strong FDA. The 21st Century Cures Act guts the power and capacity of the FDA when we need protection from pharmaceutical corporations more than ever. Don’t assume that we, collectively/institutionally, learned anything from the Thalidomide disaster. The endocrine disrupting, gut biome destroying, drugs people (including pregnant women) are ingesting today are just as dangerous as the drugs they were taking in the 1950s. We’re heading for another drug disaster, we just don’t know which drug will be the culprit.
Big Pharma in the Corporatocracy
The 21st Century Cures Act is a gift to the pharmaceutical industry. It diminishes patient safety and (further) turns the FDA into a big pharma puppet. The 21st Century Cures Act isn’t looking out for patients–no one is looking out for patients. Patients need protection from dangerous drugs though, and without adequate safety provisions enforced by strong regulatory agencies, people will be less safe. The 21st Century Cures Act will make people less safe, and will likely increase the number of people hurt and killed by dangerous pharmaceutical drugs.
The U.S. Senate is expected to vote on the 21st Century Cures Act as soon as today (12/5/16). Please call, write, tweet, or otherwise contact your Senators ASAP to voice your concerns about this dangerous bill.
I have very little hope or faith that this horrible bill will fail to become law, but it is still possible. I encourage each and every one of you to call, write, email, or tweet your Senators to let them know that a bill that encourages fraud and bribery should not become law.