The Skeptics Society & Skeptic magazine

Health Freedom, Right to Try, and Informed Consent

Starting with the Terrible Twos, when toddlers hear the word “No” on a regular basis, people don’t like to be told they can’t do something. They often believe government regulations interfere with their rights. The government requires vaccinations for school attendance; parents complain that they should be able to make their own decisions about whether to vaccinate their children. The government requires that drugs be approved by the FDA before marketing; desperate patients dying of cancer complain that regulations are preventing them from getting the one new treatment that just might save their life.

Victims of disease do not demand quack treatments because they want to exercise their “rights,” but because they have been deceived into thinking that they offer hope.

Health Freedom

The “health freedom” argument is that everyone has the right to use whatever treatments they want, to control what goes into their bodies, and that it’s none of the government’s business. But as Stephen Barrett and William Jarvis explained on Quackwatch:1

Quacks use the concept of “health freedom” to divert attention away from themselves and toward victims of disease with whom we are naturally sympathetic. “These poor folks should have the freedom to choose whatever treatments they want,” cry the quacks—with crocodile tears. They want us to overlook two things. First, no one wants to be cheated, especially in matters of life and health. Victims of disease do not demand quack treatments because they want to exercise their “rights,” but because they have been deceived into thinking that they offer hope. Second, the laws against worthless nostrums are not directed against the victims of disease but at the promoters who attempt to exploit them.

Vaccine refusers don’t recognize that the government has a duty to protect the welfare of children and to protect the population from vaccine-preventable diseases. They tend to think parental rights and personal preference should trump everything else.

People go to other countries to get stem cell treatments that have not been tested, and cancer treatments like Laetrile and the Gonzalez protocol that have been tested and shown not to work. In a trial of pancreatic cancer, patients treated with the Gonzalez regime survived on average for 4.3 months; those using standard chemotherapy survived on average for 14 months and reported a better quality of life. But desperate patients still want to believe in these treatments and they insist it was wrong of the government to prohibit them in the U.S.

Right-to-Try Legislation

As of May 30, 2018, 38 states already had right-to-try laws and there is now a federal right-to-try law. It gives terminally ill patients the right to get experimental drug treatments that have not been approved by the FDA, that are still in clinical trials, as long as they have passed a phase 1 trial, the first step in the Food and Drug Administration’s approval process. At first glance, it sounds like a good idea; but the devil is in the details. The FDA already has an Expanded Use or Compassionate Use policy.2 It can be used when:

  • Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
  • There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
  • Patient enrollment in a clinical trial is not possible.
  • Potential patient benefit justifies the potential risks of treatment.
  • Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development, or marketing approval for the treatment indication.

Over a ten-year period from 2005 to 2014, there were 9,000 applications to use investigational drugs; 99% of these were approved. Emergency requests are usually granted immediately over the phone, and non-emergency requests are generally processed within a few days.

My colleagues on the Science-Based Medicine blog, cancer researcher/surgeon David Gorski and lawyer Jann Bellamy, have covered this legislation extensively and have pointed out a number of problems:

  • It cuts the FDA out of the loop, so it doesn’t have the opportunity to offer other options that might be safer or to give the patient what information it has about possible side effects.
  • It removes the right to sue: doctors and drug companies are not liable for any harm that might occur to patients under this program.
  • There is no oversight by an Institutional Review Board (IRB).
  • It assumes that it is safe to try drugs that have passed phase 1 trials; these trials only involve a few patients and can’t establish drug safety. After drugs pass phase 1 testing, there are still high odds that they don’t work and aren’t safe.
  • It forbids the FDA from using any information about deaths or other harms to patients under this program from being considered in its deliberations on approving the drug.
  • It exposes patients to exploitation.
  • It is a foot in the door to furthering undermining the authority of the FDA.
  • The drug companies are not obligated to provide the drug, but they have no incentive not to. They can charge the patient whatever they want, they incur no liability, and if the drug kills the patient, the FDA can’t use that information to delay or stop approval of the drug.
  • Insurance companies don’t pay for experimental treatments; drug manufacturers can charge patients whatever they choose. Less well-to-do patients will either forgo treatment or deplete their finances, depriving their survivors of an inheritance.
  • Terminal patients who have “nothing to lose” actually do have something to lose: money, quality of life, time with loved ones.
The Origin of Right-to-Try

David Gorski calls right-to-try laws “a cruel sham and scam.” He says they were concocted by “the quackeryfriendly for-profit hospital chain the Cancer Treatment Centers of America and foisted on gullible legislators by the Goldwater Institute, a libertarian propaganda group disguised as a think tank.3 It was the Goldwater Institute that came up with the name “right-totry,” wrote model legislation, and promoted it to state legislatures.

The Profiteering Begins

The new law allows drug companies to make money by selling unproven therapies to desperate patients. Unscrupulous drug companies will be incentivized to skip the traditional clinical trial and FDA review process altogether.4 Brain- Storm Cell Therapeutics, for example, is already planning to take advantage, offering stem cell treatments to patients with amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease). It plans to charge $300,000 for each NurOwn treatment. In the company’s own phase 2 trial, NurOwn failed to slow the progression of ALS compared to a placebo. They nevertheless embarked on a phase 3 trial. Without waiting for trial results, they decided to offer the treatment to patients under right-to-try because of “intense demand from patients who have no other options.”

Informed Consent

One of the major principles of medical ethics is autonomy, the right of the patient to self-determination. In earlier days, doctors were paternalistic. They decided what was best and ordered whatever treatment they chose. They were like parents saying, “You will eat your broccoli because I say so. Mommy knows best.” Those days are long gone. Today, patients have the right to make decisions about their own health and to refuse treatment, even essential lifesaving treatment, as long as they are of sound mind. Consent to treatment is meaningless unless it is informed consent. Patients must be given adequate information and must be able to understand the diagnosis, what the proposed treatment will entail, the risks and benefits of the treatment, the consequences of not treating, and whether any other treatment options are available.

Consent to treatment is meaningless unless it is informed consent.

Informed consent is mandated by both ethics and law. No one has the right to even touch, much less treat, another person without consent; such actions can be prosecuted as physical assault or battery. Obtaining consent is considered a must for anything other than a routine physical examination.5 Entering the doctor’s office and expressing a problem can be considered implied consent for a physical examination. Intimate examination (especially of a female), photography, and any invasive test or risky procedure requires specific expressed consent, which can be either oral or written. Written consent is preferable. Doctors are expected to document in the patient’s chart that they have discussed all the pertinent facts with the patient; and for surgery, the patient is required to sign an informed consent form.

In everyday practice, informed consent is not always honored. Doctors may not take the time to explain everything in detail. They may influence the patient’s decision by their language or by the way they present the facts or omit some information. Patients regularly sign surgical consent forms without reading them.

I worry that under the right-to-try law, patients may not fully understand the risks and the low probability of success, and drug companies may take advantage to sell their products to desperate individuals at inflated prices. I worry that since these patients weren’t able to qualify for clinical trials, they may be less healthy and more likely to suffer problems with the experimental treatments than those who enroll in the trials; they may have other medical conditions or factors that make them more susceptible to complications.


No reasonable person wants health freedom without information. Imagine a world without laws, where patients are free to use any treatment any quack or snake oil salesman might invent, where patients can’t give informed consent and have no way of knowing what they are getting into. We rely on laws to protect us from contaminated and adulterated foods. We rely on the FDA to protect us from dangerous drugs and disasters like Thalidomide. As Jann Bellamy summarized:

The claims that “potentially lifesaving” drugs will actually benefit terminal patients are overblown, the risks underappreciated, and the procedures for obtaining unapproved drugs inadequate to protect patients from adverse consequences, both medical and financial. END

About the Author

Dr. Harriet Hall, MD, the SkepDoc, is a retired family physician and Air Force Colonel living in Puyallup, WA. She writes about alternative medicine, pseudoscience, quackery, and critical thinking. She is a contributing editor to both Skeptic and Skeptical Inquirer, an advisor to the Quackwatch website, and an editor of, where she writes an article every Tuesday. She is author of Women Aren’t Supposed to Fly: The Memoirs of a Female Flight Surgeon. Her website is

Inline Feedbacks
View all comments

This site uses Akismet to reduce spam. Learn how Akismet processes your comment data. Comments are closed 45 days after an article is published.


Get eSkeptic

Be in the know!

Subscribe to eSkeptic: our free email newsletter and get great podcasts, videos, reviews and articles from Skeptic magazine, announcements, and more in your inbox twice a week. It’s free. We never share your address. Unsubscribe any time.

Sign me up!


Skeptic cover art by Pat Linse

Art of the Skeptic

In celebration of Skeptic magazine’s 100th issue, we present sage graphic art advice for skeptical groups and a gallery of art reflecting more than 47 years of skeptical activism from Skeptic’s long time Art Director, Pat Linse

Detecting Baloney

Baloney Detection Kit Sandwich (Infographic) by Deanna and Skylar (High Tech High Media Arts, San Diego, CA)

The Baloney Detection Kit Sandwich (Infographic)

For a class project, a pair of 11th grade physics students created the infographic shown below, inspired by Michael Shermer’s Baloney Detection Kit: a 16-page booklet designed to hone your critical thinking skills.

FREE PDF Download

Wisdom of Harriet Hall

Top 10 Things to Know About Alternative Medicine

Harriet Hall M.D. discusses: alternative versus conventional medicine, flu fear mongering, chiropractic, vaccines and autism, placebo effect, diet, homeopathy, acupuncture, “natural remedies,” and detoxification.

FREE Video Series

Science Based Medicine vs. Alternative Medicine

Science Based Medicine vs. Alternative Medicine

Understanding the difference could save your life! In this superb 10-part video lecture series, Harriet Hall M.D., contrasts science-based medicine with so-called “complementary and alternative” methods.

FREE PDF Download

Top 10 Myths of Terrorism

Is Terrorism an Existential Threat?

This free booklet reveals 10 myths that explain why terrorism is not a threat to our way of life or our survival.

FREE PDF Download

The Top 10 Weirdest Things

The Top Ten Strangest Beliefs

Michael Shermer has compiled a list of the top 10 strangest beliefs that he has encountered in his quarter century as a professional skeptic.

FREE PDF Download

Reality Check: How Science Deniers Threaten Our Future (paperback cover)

Who believes them? Why? How can you tell if they’re true?

What is a conspiracy theory, why do people believe in them, and can you tell the difference between a true conspiracy and a false one?

FREE PDF Download

The Science Behind Why People See Ghosts

The Science Behind Why People See Ghosts

Mind altering experiences are one of the foundations of widespread belief in the paranormal. But as skeptics are well aware, accepting them as reality can be dangerous…

FREE PDF Download

Top 10 Myths About Evolution

Top 10 Myths About Evolution (and how we know it really happened)

If humans came from apes, why aren’t apes evolving into humans? Find out in this pamphlet!

FREE PDF Download

Learn to be a Psychic in 10 Easy Lessons

Learn to do Psychic “Cold Reading” in 10
Easy Lessons

Psychic readings and fortunetelling are an ancient art — a combination of acting and psychological manipulation.

FREE PDF Download

The Yeti or Abominable Snowman

5 Cryptid Cards

Download and print 5 Cryptid Cards created by Junior Skeptic Editor Daniel Loxton. Creatures include: The Yeti, Griffin, Sasquatch/Bigfoot, Loch Ness Monster, and the Cadborosaurus.

Copyright © 1992–2021. All rights reserved. | P.O. Box 338 | Altadena, CA, 91001 | 1-626-794-3119. The Skeptics Society is a non-profit, member-supported 501(c)(3) organization (ID # 95-4550781) whose mission is to promote science & reason. As an Amazon Associate, we earn from qualifying purchases. Privacy Policy.