Scientists wary as Texas mulls allowing sale of unproven drugs – Bryan-College Station Eagle

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 ofHouse Bill 3236by 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.

Its the dirtiest, most corrupt, most transparently fraudulent bill Ive ever seen in my life, said Will Decker, a Houstonimmunologist 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 advocatesthat terminally ill patients should be allowed to try long-shot therapies that havent 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 havepassed similar laws. Of those, Texas is the only statethat prohibits patients from paying for experimental drugs, said Starlee Coleman, a policy adviser for the Arizona-based institute.

In an interview, Kacalsaid 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 dont think the patient or the doctor is going to argue, he said. Were going to find a way to get that product to the individual.

The FDA already has a compassionate use program to helpterminally ill peopleaccess 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 FDAs phase 1 clinical trial, which essentially verifies that the drug will not harm a patient but doesn'tprove a drugs effectiveness.

The 2015 law requirespharmaceutical companies to provide experimental drugs without compensation, butKacals bill would allowdrugmakers tocharge patients for the costs of, or the costs associated with, the manufacture of the investigational drug.

Federal regulations prohibit companies fromprofiting fromexperimental medicine. Michelle Wittenburg,a lobbyist and president of theKK125 Ovarian Cancer Research Foundationwho supports Kacals bill,said thereare 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.

Youd 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 Perryused to serve on its board (the company was involved in a back surgery Perry underwent in 2011 in which he received anexperimental injection of his own stem cells, a therapy that isnt FDA approved). In 2013, after a warning from the FDA, the companymoved 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.

Read more here:
Scientists wary as Texas mulls allowing sale of unproven drugs - Bryan-College Station Eagle