You or a loved one may one day face down a terminal illness that conventional treatments can’t cure. Yet there may be “investigational” or “experimental” drugs out there that could alleviate suffering. Or even prolong life. The problem is that the FDA might take years to approve such drugs.
This keeps potentially effective treatments locked away from patients who need them now. Some promising drugs may never get approved.
People with terminal illnesses might prefer to take an investigational drug that has promise rather than spend time they don’t have waiting to see if it gets full FDA approval.
The FDA does have procedures through which those with life-threatening ailments can request unapproved drugs. The forms and attachments that patients must fill out to apply for access to unapproved drugs are so complex that they can take several days to complete. It’s easy to imagine a cancer patient dying prematurely just from the stress and exhaustion of dealing with the FDA. And all that time and effort might be for nothing since the FDA regularly rejects requests from patients to try investigational drugs.
This New Trend in State Law May Help Cancer Patients Get Experimental Treatments
Shouldn’t people with no other options be able to try new medications from reputable drug makers without having to seek permission? That’s the idea behind so-called Right to Try laws, which are proliferating at the state level.
On April 3rd, Tennessee became the 14th state to pass Right to Try legislation. More than 20 other states are considering such measures, according to the Tenth
Amendment Center. In the states where Right to Try has come before legislators, the law has garnered surprisingly strong bipartisan support. In some states, support has been unanimous.
Under Right to Try, states are essentially nullifying FDA bans in limited areas for compassionate purposes. The law enables patients to use drugs that have passed the FDA’s first phase of safety tests. Patients and doctors are allowed to obtain experimental drugs directly from drug companies. At least in theory.
FDA Still Stifles Terminal Patients From Getting Cutting-Edge Unapproved Drugs
In practice, few drug makers are willing to make their yet-to-be-approved products available to the public under any circumstances for fear of upsetting the FDA. Selling a drug without the blessing of FDA overlords is simply too risky a business proposition.
That’s why a federal Right to Try law is needed. Such a law could force the FDA to make drugs more easily accessible for compassionate use.
FDA bureaucrats, in an attempt to placate Right to Try advocates, have streamlined the process for terminally ill patients seeking trial-period drugs. The agency’s new form will supposedly take only 45 minutes to complete and require only one attachment from a physician.
Circumvent Cancer Drug Mess Through Medical Tourism
One way around FDA prohibitions on promising drugs and treatments is to seek them outside the country. Medical options that aren’t legally available in the United States may be available elsewhere.
Another reason to seek treatment abroad (and the most common one) is lower costs. If you are considering an elective surgery that isn’t covered by insurance, you may be able to save a huge amount by getting it done as a medical tourist.
You may also be able to obtain medication on the cheap. A biotechnology company will typically have to spend $1 billion or more on developing a new drug before it meets with FDA approval. The only way for drug makers to recoup those costs is by charging a lot for their drugs. Yet identical drugs may sell in foreign countries at a fraction of what you’d pay at a U.S. pharmacy.
If you’re considering buying drugs in or from foreign countries, be aware that pirated and fake pharmaceuticals circulate in some countries. They could be dangerous. Those who become medical tourists in order to escape restrictions in their home countries have been dubbed “circumvention tourists.” It’s a growing segment of the medical tourism industry.
According to authors Jeremy Snyder and Valorie Crooks, “Now China, Russia and countries in the Caribbean are positioning themselves as destinations for another kind of medical visitor: the circumvention tourist. Increasingly people are traveling abroad for care that is unapproved by regulators in their home countries.”
Snyder and Crooks note that the Bahamas can be a convenient place to obtain treatments that have yet to be approved in the U.S. For example, high-intensity focused ultrasound treatment for prostate cancer is available in the Bahamas. Canada and the European Union, too. But the procedure hasn’t been approved in the U.S.