Robert is a freelance writer/researcher in the Seattle, WA area. He covers current political, economic, and geopolitical news.
Right to Try Medical Access
Right to Try allows a patient to access investigational medications when the following conditions are met.
- The patient has been diagnosed with a terminal disease;
- the patient has considered all available treatment options;
- the patient’s doctor has recommended that the investigational drug, device, or biological product represents the patient’s best chance at survival;
- the patient or the patient’s guardian provides informed consent; and
- the sponsoring company chooses to make the investigational drug available to patients outside the clinical trial.
Why "Right to Try" Is a Good Idea
“Right to Try” allows terminally ill Americans to decide for themselves which medicines to try and not try, as long as they are still safe to use. For example, giving a right to try medicines that have passed the first phase of U.S. Food and Drug Administration (FDA) approval but are not yet on pharmacy shelves. Right to Try would expand access for those qualified to try potentially life-saving treatments that have been approved and are in use in European countries, but not yet in the regulated United States of America.
Over 1 million Americans die every year from some terminal illness. Many spend years searching for a cure, unable to access some readily able prescriptions because the government restricts access to these promising new treatments. A Sacramento Bee headline stated that the Right to Try legislation offered “false hope to the desperately ill.” So it is now in the government’s realm of responsibilities to decide how much hope its citizens should have?
In October 2015, California Governor Jerry Brown vetoed a Right to Try bill, yet California legislators sent a similar bill to his desk again last fall. The Bee article in opposition to Right to Try referenced in the paragraph above actually mentioned that Right to Try would “harm patients.” Though it did not go into detail as to how that would happen. The article goes on to state that they are against the recently proposed legislation, stating that “it is in the best interest of terminally ill Californians and their loved ones that the governor veto this bill again.”
Amazingly, Governor Brown signed it into law this time around. In late September 2016, Brown signed the legislation into law giving terminally ill Californians access to experimental drugs not yet fully approved by the FDA. As long as the treatments have “passed basic safety testing,” patients can try the medicines as long as they meet certain requirements. Patients do need to have a certain matter of months to live and multiple doctors must recommend they try the drug in question.
So, Right to Try is finally gaining traction across America. Right to Try is now law in 33 states and legislation is proposed in 14 more, including my evergreen state of Washington.
To opponents of Right to Try who claim that patients can already access investigational treatments by participating in clinical trials, making Right to Try unnecessary, they need to realize that only 3% of terminally ill patients actually gain access to these investigational treatments in clinical trials. So, Right to Try is designed to help the other 97%.
Other opponents say that these experimental treatments are unsafe. However, this is not the case. The only treatments available under Right to Try are those that have already passed the FDA’s basic safety testing and are still “within the FDA’s approval process.” So, with these common sense points flying in the face of the dwindling number of critics, support for Right to Try is resulting in the law being enacted by state governments, as state capitols take matters into their own hands.
States do have the right to enact this type of legislation into law. FDA regulations cannot preempt state laws that “preserve constitutionally protected rights,” like the right to live and medical self preservation. The U.S. Supreme Court has never addressed this matter directly in court, but it has held that states have the right to regulate the safety and health of their own citizens within their own state’s borders.
The Goldwater Institute Staunchly Defends Right to Try
The Goldwater Institute, a Phoenix-based conservative and libertarian think tank, believes that everyone deserves the right to try. They wrote a detailed policy report in early 2014 in strong support of Right to Try with comprehensive research to prove its case.
Unfortunately, the federal government is doing little to nothing to make Right to Try federal law. Since 2008, four bills have been introduced in Congress to broaden access to medicines and treatments for terminal patients, however, “none received a vote in committee, let alone a floor vote,” according to The Goldwater Institute report.
It is incomprehensible that we have to craft legislation to allow the individual to protect his or her own life. Right to Try laws recognize this right to life by allowing a person to defend themselves by trying to stay alive by whatever costs and means necessary. Through a lengthy approval process for life-saving drugs, the FDA has denied this right to self-defense for many Americans. This is a sad, but unfortunate reality, and one that must be overcome by our federal and state lawmakers.
The Goldwater Institute report stated that “To protect the rights of patients with immediately life-threatening conditions, states should pass ‘Right to Try’ legislation.” And a solid majority have passed legislation since the release of this report. An astonishing 48 states and DC have already enacted or proposed Right to Try legislation.
Right to Try does not give unfettered access to drugs for patients to try whatever and whenever they want. This is a last case scenario and is only done if the patient is well aware of the risks associated. The fact that some of these medicines have not yet proven wholly effective is irrelevant. If the patient consents to use the drug or treatment, then that is all that is required. These experimental drugs are already approved for use for hundreds of thousands of people in other states in America and other countries around the world. This is not a controversial piece of deregulation. This is common sense.
Right to Try should be made law in every state in America. Right to Try is right for America. Just as the repealing of Dodd-Frank regulations would be great for the banking industry and the building of the Keystone XL pipeline good for the oil, gas, and construction industries, this opening up of medicine for the terminally ill, could prove literally life-changing for for many.
We cannot allow unelected government bureaucrats at places like the FDA determine who lives and who dies. We cannot allow our liberty to be restricted by a government agency, asserting itself by slow walking certain treatments and enforcing overreaching regulation. Delaying access to potentially life-saving medications is cruel and should be stopped right away. Let’s hope this gets the attention of the Trump administration because this is a slam dunk issue.
The Federal Government Must Take Up Right to Try Legislation Now
Darcy Olsen, president of the Goldwater Institute wrote an essential book on this topic, The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need. Ben Shapiro calls it a “must-read rebuttal of the left’s number one argument for big government: the Food and Drug Administration (FDA) protects us from evil capitalists who would alternatively poison us or toss us into meat grinders...” Olsen’s book argues that the federal government is killing terminally ill Americans with its onerous bureaucracy and belief that they should protect sick Americans by making their decisions regarding their sickness for them.
The Goldwater Institute stated that we cannot wait for the FDA to change its ways. Bureaucracies are slow moving and defend their own way of doing things. The report concluded that “Without state action, terminal patients are at the mercy of a federal bureaucracy that can literally cause death by delays, denials, and unnecessary procedural requirements.” The government and its agents are supposed to protect the people, not literally kill them or determine how much hope they should have.
In a moving example, the Goldwater report told the story of Edie Bacon. She wrote of her struggles as a terminal patient, pleading to the government for help while venting her frustrations. “The government wants proof of efficacy before it will allow me to take this drug outside of an approved trial.” Luckily, this is slowly but surely not becoming the case anymore. Bacon continued, saying the drug might work and it is safe. Sadly, she said, “Johnson & Johnson would let me have it if they could do so without the threat of a government hassle. But they’re so caught up in the FDA web that the life of an individual patient has no importance whatsoever. Without ET 743, I’m a dead woman walking.” Edie died two years later.
Has our federal government become so large, unaccountable, uncaring now that it does not even care for the lives of the citizens? Do we still have a government that stands in the way of a cure for those nearing or on their death beds? All Americans have a right to defend themselves and that includes taking whatever medications they can, within reason. In a country where people supposedly have certain “unalienable Rights,” such as “Life, Liberty, and the Pursuit of Happiness,” shouldn’t it's people not have to plea to the government for protection outside of the overall defense of the country? Shouldn’t the very ill be allowed to do what they can to save their lives within a properly approved, streamlined, and supervised fashion?
States across this great country are taking it upon themselves to make sure that people have the Right to Try. When will our federal lawmakers wake up and realize that this needs to be the law of the land? Well, apparently last year and the year before that. But, will they listen to rest of the country this time around?
In July 2015, a federal Right to Try bill was introduced in the House of Representatives but is now dead. A Senate bill was introduced in May 2016, a hearing was held in September 2016 and it is now in the Senate Committee on Homeland Security and Governmental Affairs. We’ll see if it gets out of there and to the floor for a vote.
The Right to Try is right for America. Let’s make the choice not liberty or death. Let’s have liberty and give terminally ill Americans the chance to keep on living. Let’s give them the right to try to save their lives.