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10/05/2016

Right to Try is A Snake Oil Sale to “Dismantle the FDA”

by Craig Klugman, Ph.D.

Right to Try laws have been getting a lot of press lately with California being the 32nd state to pass such a statute. The goal of such laws is to gain terminally ill patients access to experimental treatments (those compounds that have passed phase 1 clinical testing). The laws create a bypass around the FDA allowing patients to directly approach companies for compassionate use. They are an attempt to disempower the FDA and allow people to try any drug they wish. However, since federal law supersedes state law, these statutes are essentially meaningless except for scoring political points.

The movement to write such bills and pass them as laws comes from the Goldwater Institute, which claims to be “leading a national movement to use state constitutions and powers reserved to the states to restore and expand our freedoms.” This is an organization that by its philosophy supports states law trumping federal through “limited government.”

Even the pharmaceutical companies have joined this parade. Last week I received a press release from a marketing firm letting me know that company Q had received 160 requests for compassionate use and their compassionate use advisory committee recommended access to an experimental drug for 60 patients. They are proud of providing access to unproven compounds to sick people. Does allowing people to risk their lives on a pale hope make them seem like a good company? Just because people ask does not make these programs right.

So what do these laws, a states-rights think tank and big pharma have in common: A desire to curtail or dismantle the FDA. After all, it is the FDA that requires expensive and rigorous testing of drugs. It is the FDA that uses the full power of the federal government to approve drugs and open lucrative markets to manufacturers. And according to the Goldwater Institute, the FDA prevents sick people from getting their hands on experimental compounds that they hope may help.

The problem is this assumption that these experimental treatments are cures that the government is keeping from the public came up In a recent radio interview I did. The reporter said to me, “But what about the mother who is dying of cancer and wants to see her new baby grow up, shouldn’t she have a chance?” I didn’t know where to start so explained the therapeutic misconception and then the logical fallacy of appealing to emotion. These are experimental drugs being given to the sickest patients. Perhaps, instead, we could refer them to hospice and offer them counseling for how to making meaning out the end of their lives. I know as a society that we do not like to face reality, but the potential for harm in use of these compounds outweighs the risks even for a willing participant.

And that’s why the FDA exists. In 1906, the U.S. Congress passed the Pure Food and Drug Act with the goal of providing consumer protection against drugs and foods that were labeled dishonestly or inaccurately. Before this time, “snake oil salesman” would create a compound and travel around selling it. The compound could make wild claims and did not have to demonstrate evidence of efficacy. No ingredients had to be listed nor did any side effects need to be explained. Often the only active ingredient was a narcotic that made patients feel good and so they thought the elixir worked. Caveat emptor was the philosophy in so-called drug sales. There was no real oversight or regulation of drugs.

The Bureau of Chemistry, which had responsibility for the 1906 law, had little power to enforce its mission. In 1927, the US founded the Food, Drug, and Insecticide organization, a name shortened to Food and Drug Administration a few years later. It was in 1938 that the Food, Drug and Cosmetic Act passed which mandated reviews of all drug for safety before reaching market, and prohibited mislabeling. The FDA ensures that drugs do what they claim to do, are safe for people to take, and are effective. The FDA is mandated to be the gatekeeper to the lucrative pharmaceutical market to protect the patient (note, I did not say consumer).

But now supporters of Right to Try laws and pharmaceutical companies proudly tout how these efforts for compassionate use provide hope to desperate patients. I suspect their real motive is to get around or to dismantle the FDA. A headline from Breitbart, “How the FDA is Killing Americans” makes this goal clear. After all, without the requirements to prove safety and efficacy, companies would save millions (perhaps billions of dollars), could make any claim they wish, and could reach any audience they want (rather than having a drug approved for a specific disease or condition only). And as an anti-federal government think tank would tell us, patients get the right to choose the medication they want, never mind that they do not necessarily know what works, how it works or doesn’t, and whether it would be harmful to them.

This is not to say that this is issue is completely the creation of political groups or an industry with medicine being on the sideline. In a recent Hastings Center Report article written by Alastair Matheson, a former pharmaceutical marketer and consultant, Matheson states that medicine is not blameless in our concerns with big pharma. After all, doctors control access to drugs. The same is true of Right to Try. Looking at company Q’s compassionate use website, it says very clearly that a patient who wants to try their drug should have her or his physician contact the company. The 60 patients who received an experimental and unproven drug were able to do so because their doctors advocated on their behalf.

These laws essentially make the FDA meaningless because they say a patient can make her or his case right to the drug company for access to any compound that has passed phase 1 (safety) testing. By cutting out the gatekeeper, the potential for profit soars, as does the chance of patients being harmed both physically and psychologically through the peddling of false hope and snake oil. Compassionate Use and Right to Try are not to be celebrated or viewed as a boon for patient rights, they are nothing less than a call to dismantle the safety system that protects us. As public health has shown there are many things that a person cannot do on her or his own such as developing a vaccine for Zika or ensuring that the air we breath is clean. A strong central effort is necessary to ensure the safety of food and drugs. That is a public, community enterprise, not an impossible individual burden.

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