Compassionate Care or Dangerous Science?

Having a terminal illness and facing the reality that you’re out of treatment options is not an easy thing for people to accept — not without a fight.

Related: Get Moving, or Get Busy Dying

Understanding patients’ fierce will to live and the desperation of families, a growing number of states are doing what they can to help. California earlier this week became the 32nd state in the past two years to authorize patients with terminal diseases access to experimental drugs. These patients will now be able to use treatments not yet fully approved by the federal government for clinical trials.

Gov. Jerry Brown of California signed Assembly Bill 1668, the so-called “right to try” bill, into law Tuesday. It clears the way for Phase I drugs to be used on patients who have only months to live, who have been unable to access a clinical trial otherwise, and who have the approval of two supervising doctors.

A similar measure in the U.S. Senate failed Wednesday, when Senate Minority Leader Harry Reid (D-Nev.) blocked passage of the federal “right to try” measure introduced by U.S. Sen. Ron Johnson (R-Wis.). The move was in retaliation for the continued Republican block of President Obama’s nominee to the U.S. Supreme Court, Merrick Garland.

Johnson called it “a sad day in the U.S. Senate when the minority leader would turn his back on terminally ill patients and their families — deny them that freedom, that right to try, that right to hope — to score a political point.”

[lz_third_party align=center includes= https://twitter.com/SenJohnBarrasso/status/781185268984475648]

Dr. David Gortler, a pharmacology expert, drug safety expert, and Food and Drug Administration policy expert at FormerFDA.com, understands why patients would seek whatever options might be available for treatment.

But knowing the damage unvetted drugs can do, he’s not sold on the plan. “The general public understands little or nothing about the drug development process,” Gortler told LifeZette. “It’s a bad idea to entrust non-experts to circumvent the experts at FDA through ‘right to try’ and to make independent choices regarding clinical pharmacology, pharmacogenomics, biomarkers, and long-term drug safety.”

The laws don’t require a company to grant a patient’s request, according to one cancer survivor.

People like Jonathan Friedlaender, of rural Connecticut, a survivor of advanced metastatic melanoma, say it’s a risk they’re willing to take — given the alternative.

“I was excluded from extremely promising clinical trials three different times and the delays in access almost killed me,” Friedlaender wrote this week in Health Affairs.

“Faced with imminent death, informed patients have the right to risk their lives by taking a promising but unproven drug, just as they have the right to decide when to terminate further treatment,” he concluded. “Withholding drugs in such situations is unethical and paternalistic — even if it may violate the physician’s Hippocratic oath to ‘first, do no harm.'”

But even Friedlaender is critical of current legislation being considered or passed, saying it offers false hope because the laws don’t require a company to grant a patient’s request.

[lz_ndn video=31249809]

“There are many reasons a drug company would not want to provide experimental and unproven drugs, including burdensome costs [especially if the company is small] and potential poor health outcomes when the drug is used in a less controlled situation with sicker patients [leading to liability or bad publicity],” said Friedlaender,

It’s a tough situation all around. Patients and their families know there are treatments in the pipeline that could potentially save their lives, and they’re willing to take the risks. Will the new laws actually give them access? This is the question.