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Conservative Think Tank Takes a Tactic From the AIDS Activist Playbook on Drug Approval Process

Advocate Says Goldwater Institute, With Guise of Compassion, Is Pushing Dallas Buyers Club Laws in Quest to Deregulate FDA

September 12, 2014

Gregg Gonsalves

Gregg Gonsalves

It's doubtful that Ron Woodroof, creator of the Dallas Buyers Club in 1988, could have imagined that his organization's name would be attached to laws passed in Colorado, Louisiana and Missouri in 2014. These Dallas Buyers Club laws, also known as Right-to-Try laws, seek to give terminally ill patients early access to unapproved drugs.

These state laws recall the spirited campaign by AIDS activists to change the U.S. Food and Drug Administration (FDA) drug approval policies in the early years of the epidemic. So why is Gregg Gonsalves, a noted AIDS activist who fought for quicker and expanded access to investigational drugs for AIDS patients, asking Congress to protect the regulatory authority of the FDA in the face of these laws?

Gonsalves notes that the Goldwater Institute, a libertarian think tank with a long history of pushing for deregulation, has taken an active role in seeing these laws passed.

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"I fear that in the guise of compassion for patients, the Goldwater Institute really is interested in dismantling the FDA and sees patients like us as useful to their cause," Gonsalves told TheBody.com. "The set-up here is that the FDA is the barrier to early access to new meds. This isn't the case; the agency approves the vast majority of expanded access requests it receives."

"Most of the time it's the companies who refuse to offer their drug on early and expanded access," he explained. "The Right-to-Try laws don't do anything to compel companies to play ball. They simply allow the Goldwater Institute's narrative to be told -- the FDA is killing patients by blocking access to new drugs. Quite ballsy, since this is the old AIDS activist cry from the '80s and '90s."

The Goldwater Institute developed the legislative language used in the state bills that have passed. According to a June 22 report in The Morning Consult, each state's bill "closely follows the Goldwater template," which includes the argument that treatment decisions should be made by patients and their doctors, not the government.

Gonsalves points out that in their desperation to find treatments, patients may not take the time to "read the fine print, " noting that there are few diseases for which there exist "the strong communities of organizations and advocates that we have in HIV/AIDS" that would help patients understand these laws. He notes that the laws protect doctors and drug companies against any legal recourse patients may seek if something goes wrong, thus contradicting claims that it's all about the patient's health and quality of life.

HIV is not considered a terminal illness, and thus the drugs approved to treat it are not subject to Right-to-Try laws. However, Gonsalves worries that safety and efficacy standards for all drugs could be affected. What about drugs for diabetes, dementia or neuropathy, all of which can affect people living with HIV? Will long-term side effects or ineffective treatment be the result of incomplete research? And would pharmaceutical companies cut back on research, in order to profit sooner from the sale of less tested drugs that come to market faster?

As of now, the FDA has constitutional jurisdiction over the approval process that drugs go through, as well as the authority to stop production of unapproved medications, including in states that have these laws. But Gonsalves believes that the goal of the Goldwater Institute is to "create a groundswell across the U.S., state by state, that says the FDA is a menace and has to be taken down." He predicts that soon there will be a bill that would weaken the agency itself.

"As AIDS activists we should be proud -- we changed the pace at which new drugs are approved in the USA and opened up new vistas for expanded access to drugs," he says. "But riding in our wake in the '80s and '90s were the right-wing's deregulationists who loved our rhetoric targeting the FDA's competency and compassion. Twenty to 25 years later, we have a weaker agency because as we left the scene after 1996, the right-wing kept at it, chipping away at the agency's authority through laws and court cases."


What Says the FDA?

The FDA seems to be playing defense at this point, pointing to its efforts to enroll patients in expanded access (also known as "compassionate use") programs and arguing that standards for those programs are more rigorous than those specified by the Right-to-Try laws. For instance, each case must be approved on an individual basis and the drugs used must be in phase 3 trials. The state laws only require that the drugs used pass phase 1 trials, which don't even include people who have the disease the drugs are meant to treat.

According to The Morning Consult report, an FDA spokesperson said, "The agency doesn't have a position on the state laws." But the statement continued, "FDA's oversight of this process provides important protections for individual patients, while also ensuring the collection of data needed to support the FDA approval of safe and effective therapies."

"As patients, we want access and answers. We want approval of new drugs without delay and without compromise on securing the evidence we need about these drugs, which we put in our bodies every day," Gonsalves argues. "This second piece is what the right-wing cares little about, even if it takes us back to the days of snake-oil salesmen."

Sue Saltmarsh has worked in the HIV/AIDS field for over 20 years, the first 10 as an herbalist and energy therapist at Project Vida, the last six as a writer and copy editor for Positively Aware magazine. She is now a freelance writer and editor and is also able to devote more time to her passion as founder and director of the Drive for Universal Healthcare (DUH).


Copyright © 2014 Remedy Health Media, LLC. All rights reserved.



  
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More on the FDA Drug Approval Process and Other Regulatory Issues

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