Scientists wary as Texas mulls allowing sale of unproven drugs

A group of scientists and medical professionals is sounding the alarm in the final days of the Texas legislative session about a little-noticed bill that would allow manufacturers of unproven drugs to sell their products to dying patients.

Supporters of House Bill 3236 by state Rep. Kyle Kacal, R-College Station, say it could help incentivize drugmakers to get promising, experimental drugs onto the market and into needy patients’ hands. Its detractors say it would allow drug companies and quack doctors to use fake medicine to take advantage of sick, vulnerable families.

After emotional pleas from state lawmakers invoking family members with terminal illness, the Texas House passed the measure earlier this month in a unanimous 142-0 vote, just minutes before a critical deadline. The bill is now waiting to be heard by the Senate State Affairs Committee.

From the House floor, Kacal — whose mother died of ovarian cancer — said he hoped it would help make experimental drugs "accessible to everybody."

Asked by state Rep. Jonathan Stickland, R-Bedford, about concerns that the proposal could have unintended consequences, Kacal said he had "vetted the bill very well."

But that has not eased the fear of some patient advocates.

“It’s the dirtiest, most corrupt, most transparently fraudulent bill I’ve ever seen in my life,” said Will Decker, a Houston immunologist who sits on the medical board for the advocacy group Texans for Cures. “It exists for one purpose and one purpose only: to let patients pay for snake oil.”

The debate this year is a new development in Texas’ “right to try” movement, which advocates that terminally ill patients should be allowed to try long-shot therapies that haven’t received final approval by the U.S. Food and Drug Administration — a process that can be lengthy.

The movement, backed by the libertarian Goldwater Institute, is gaining traction in state legislatures around the country; 35 other states have passed similar laws. Of those, Texas is the only state that prohibits patients from paying for experimental drugs, said Starlee Coleman, a policy adviser for the Arizona-based institute.

In an interview, Kacal said his bill was meant to reduce barriers for sick patients to access potentially life-saving drugs. While most drugs provided through “compassionate use” are donated to patients, free of charge, by large pharmaceutical companies, Kacal said smaller drug-makers “need to be able to recoup some costs” by charging patients.

 “If [smaller drug companies] say yes, but I need a small, nominal fee, I don’t think the patient or the doctor is going to argue,” he said. “We’re going to find a way to get that product to the individual.”

The FDA already has a compassionate use program to help terminally ill people access unapproved drugs. But few patients take advantage of the program; in 2015, about 1,900 patients applied for drugs through the program, according to STAT News.

Texas’ “right to try” law, passed in 2015, applies to drugs that have passed the FDA’s phase 1 clinical trial, which essentially verifies that the drug will not harm a patient but doesn't prove a drug’s effectiveness.

The 2015 law requires pharmaceutical companies to provide experimental drugs without compensation, but Kacal’s bill would allow drugmakers to charge patients for “the costs of, or the costs associated with, the manufacture of the investigational drug.”

Federal regulations prohibit companies from profiting from experimental medicine. Michelle Wittenburg, a lobbyist and president of the KK125 Ovarian Cancer Research Foundation who supports Kacal’s bill, said there are simply not enough patients receiving drugs through the federal compassionate use program to tempt bad actors who might want to take advantage of desperate people.

“You’d have to have a lot of people seeking and getting it for anyone — even someone trying to be a bad actor — to actually make money off of it,” she said.

The measure is backed by industry players including CellTex Therapeutics, a stem cell research company known in Texas political circles because former Gov. Rick Perry used to serve on its board (the company was involved in a back surgery Perry underwent in 2011 in which he received an experimental injection of his own stem cells, a therapy that isn’t FDA approved). In 2013, after a warning from the FDA, the company moved its treatment operations to Mexico.

Sally Temple, the president of the International Society for Stem Cell Research, wrote Texas lawmakers this month to oppose the bill, saying it would “allow companies to sell unsafe and ineffective therapies.

“It may sound like an appealing idea to allow seriously ill patients accelerated access to experimental therapies,” she wrote. “However, in the absence of full clinical testing, these bills will allow snake oil salesmen to sell unproven and scientifically dubious therapies to desperate patients.”

Disclosure: CellTex Therapeutics has been a financial supporter of The Texas Tribune. A complete list of Tribune donors and sponsors is available here.