Local Cancer Researcher: "Right to Try" the Wrong Solution for Patients

posted by 1200 WOAI -

It's called 'Right to Try,' and the idea is to give access to untested and unapproved drugs to people with terminal diseases.  The bill was signed on Wednesday by President Trump, but internationally recognized cancer researcher Dr. Anthony Tolcher, the founder and CEO of San Antonio's Next Oncology, says its a bad idea and the wrong way to go about getting treatments to patients, News Radio 1200 WOAI reports.

"First and foremost, it is 'do no harm'," Tolcher said.  "That is one of the gold standard principles that we live by in medicine.  But even with drugs that might seem to be perfectly sound, it could lead to side effects."

Tolcher says the best way to accomplish the worthy goal of getting treatments to patients more quickly and efficiently, would be for the government to allow the expansion of the rules for clinical trials of promising drugs for cancer and other ailments. 

He says the current FDA approved procedure for getting promising therapies to patients is to conduct clinical trials, where are carefully controlled, monitored, and peer reviewed studies of the effect of the drugs on real patients, many of the same people who will be receiving completely untested and unsupervised drugs under the 'Right to Try' law.

He says allowing pharmaceutical companies to simply supply untested drugs to patients is a recipe for ruinous lawsuits which could set back the effort to get those drugs to the patients who need them.

"I can see that lawyers will jump all over the pharmaceutical companies if a bad outcome happens."

Oncologists have long been calling for a broad expansion of the very carefully enforced regulations for clinical trials, which Dr. Tolcher says now are limited to a carefully selected subset of patients, and are generally conducted only in the major cities and medical centers where firms that conduct clinical trials are located.

"If you really want to be able to make experimental therapies available to patients who have serious or terminal conditions, then you have to actually broaden the scope and spectrum of clinical trials right across the country to small towns, medium towns, and not just large centers."

He says 'less than 3% to 5%' of patients who could benefit from inclusion in clinical trials, many of the same people who will take advantage of the 'Right to Try' law, will have the opportunity to participate in clinical trials.

Medical reseachers, for example, say clinical trial regulations could be expanded to include adolescents over 12 years of age, people with HIV who are otherwise healthy, and people who suffer from diseases other than the one the drug being tested is designed to treat."

They could make allowances for sites that if they place patients for clinical trials they can score some sort of credit," he said.  "You can make it easier from a regulatory standpoint to open up studies in small communities."

He says that would also have the added advantage of making the studies more inclusive so the results can be generalized to real world populations.

"There's a disconnect between where the studies are and where the patients are," he said.  "Previously the expectation was that patients would come from all the surrounding areas to go onto National Cancer Institute studies.  That was fine when the NCI was in the business of drug discovery and first in human type clinical studies, bu that's al changed.  Almost every single new drug comes from biotech and the pharmaceutical industry."

Comments

title

Content Goes Here

This ad will close in X seconds.