If you or a loved one were dying of a terminal illness and your doctor told you there were no proven treatments, would you take the risk of trying an experimental, unproven drug?
Many patients would say yes. But as with most medical decisions, the more you know, the more you realize the answer is not so simple.
As has been clearly shown, Congress is not very good at making complicated and nuanced decisions about medical care.
That’s reason enough to question the new federal Right to Try Act dozens of senators and representatives are pushing this spring.
The most important thing to know is that all terminally ill patients already have a right to try experimental drugs in this country.
The proposed new law, however, is much more dangerous to all patients, and not just those facing fatal illness.
The current national expanded access program enables doctors to request experimental drugs for their patients. If the company that makes the treatment agrees, the patient will get the treatment for free or at cost; companies are not allowed to sell experimental drugs for a profit.
Many patients get access to experimental drugs through this existing program, and improvements are underway to further streamline the process.
In contrast, under the proposed new law, a drug company could charge desperate patients as much as they want to get access to an experimental drug.
Since insurance companies do not pay for experimental treatments, many patients would wind up with the right, but not the money, to try such regimens. Out of desperation, some would surely go into debilitating debt to try a drug that might harm rather than help them.
The current national program makes sure patients understand the risks of taking an experimental treatment and requires that the drug has been studied enough to know that the patient might possibly benefit from it.
Under the proposed new law, drugs that were only studied at a low dose on a small number of healthy volunteers could be sold to patients, and unethical doctors could receive kickbacks for persuading patients to try treatments that will not help them.
It’s easy to understand why every patient wants to have hope of a cure, and that’s the power of right-to-try laws.
So far, hype and false hope have convinced 33 states to pass right-to-try laws that provide no real advantage over the current national program. But rather than learning from the mistakes at the state level, patient activists and others are pushing Congress to pass a much more dangerous federal law.
In addition to encouraging the sale of unproven treatments at sky-high prices to desperate patients, the 2017 federal Right to Try Act would do the following:
- Allow the sale of almost all experimental drugs, even those never tested on patients before.
- Prevent patients and family members from suing the company if the treatment harms or even kills them.
- Prohibit doctors and scientists from evaluating the benefit or harm of the experimental drugs.
Desperate patients are lobbying for the bill, but do they realize what they are lobbying for?
Instead of getting access to free experimental drugs that have some evidence of benefit and are being tested to help all patients, this law would allow naive and desperate patients to be exploited by greedy companies and unethical doctors.
The right-to-try movement opposes the FDA for what’s described as “interfering” with the doctor-patient relationship. They do not understand that unbiased scientific evidence is needed to help physicians and patients make informed decisions – whether to save a life or make a patient’s last months as enjoyable as possible.
Patients already have a right to try through the FDA’s humanitarian expanded access program, which gives them hope while protecting them from greedy exploitation. The proposed federal Right to Try Act would not.
On the other side of the debate, Naomi Lopez Bauman of the anti-FDA Goldwater Institute wrote a misleading article about why they support a national Right to Try law.
Let’s set the record straight on at least a few of her misstatements::
- She claims that companies are prohibited by law from charging more for the investigational treatments than their “actual cost.” That is true of current law. However, the national Right to Try Acts that are being considered in Congress specifically allow companies to determine what they will charge for their experimental drugs.
- She states that in 2015, FDA only allowed 1,300 patients to have access to experimental drugs through their Expanded Access program. That is true but very misleading, because the FDA is approving 99% of the applications to participate in the program. The reason the number is low is that when doctors request access for their patients, the companies that are being asked to make their drugs available are not always willing or able to do so. In some cases, they don’t have enough of the experimental drug available. In other cases, they believe that the specific patient requesting the drug could be harmed and would not be helped by taking the drug.
- She states and implies that the national law would not change FDA safeguards and would do no more than make the current state laws national. That is not true. On the contrary, the national law would eliminate the role of the FDA from these decisions and the protections that current law provide to prevent patients from being exploited by greedy companies or doctors.
- She states that “promising new treatments” take more than a decade to be approved by FDA. We don’t know where that inaccurate statistic comes from, but we do know that the average drug is approved about a year after it is submitted to the FDA, and an article in Cancer World concluded that the FDA approves drugs an average of 6 months faster than the European medical agency
- She expresses concern that “FDA would retaliate” against those utilizing Right To Try laws. There is zero evidence to back up that statement. That is just anti-FDA rhetoric.
- She states that “most” of the 78 patients treated by an “oncologist” under the Texas Right to Try law “are doing very well,” according to his testimony before a U.S. Senate committee. If you watch the video of his statement online, you can see the doctor who testified (Ebrahim Delpassand, who is a radiologist, not an oncologist) never said “most are doing very well.” He said that the treatment “has helped many” of the patients, but he doesn’t say how many or to what extent the treatment helped, nor does he say how many were hurt by the treatment.
- She says something is wrong because “fewer than one-tenth of 1 percent of terminal patients can take advantage of the FDA’s compassionate use exception.” But the truth is that experimental drugs are just that: experimental and not proven to work or be safe. Patients can die sooner and in agony from experimental drugs, especially those that have only gone through tiny, preliminary studies of a few healthy volunteers or patients (as the proposed national law would allow). She neglects to mention that only about 15% of the drugs that complete those preliminary trials are eventually proven to be safe or effective. The other 85% are either not safe, not effective, or both. That is a very important reason why most patients (and their doctors) do not seek experimental treatments even when they know they can.