Right-To-Try Drug Laws Create Chaos, Villainize FDA, Experts Say
The popular measures undermine a more thoughtful federal program that balances patients’ need for options, drug companies’ desire to protect their investments, and the government’s duty to evaluate drug safety and effectiveness, they say.
Los Angeles Times:
Dying Patients Want Easier Access To Experimental Drugs. Here's Why Experts Say That's Bad Medicine
Former firefighter Mike DeBartoli is a man desperate to rescue himself. He suffers from amyotrophic lateral sclerosis, the degenerative nerve disorder better known as Lou Gehrig’s disease, which usually kills within five years. He has already spent one year in a clinical trial, taking four pills a day that may have been a placebo. It didn’t help. (Healy, 3/13)
In other pharmaceutical news —
Will New Biotech Products Outpace The Regulatory System?
The Trump administration, of course, has suggested that the Food and Drug Administration, among other government agencies, must cut two regulations for every one that they adopt. Dr. Scott Gottlieb, his nominee to head the FDA, may have his own ideas on the subject. That said, the report suggests that the current level of expertise available at the FDA, along with the Environmental Protection Agency and the Department of Agriculture, likely isn’t sufficient to address the burgeoning biotech sector. The report itself was actually commissioned by these three agencies, lending some insight into their general stance on the issue. (Keshavan, 3/13)
New Class Of Cancer Drugs Might Reach A Broader Market
One in five women with breast cancer could be treated effectively with PARP inhibitors, according to a new study published Monday in Nature Medicine. The previous school of thought was that PARP inhibitors, a class of drugs that interfere with DNA repair, only work in patients with certain mutations in the BRCA1 and BRCA2 genes. It’s estimated that between only 1 and 5 percent of women with breast cancer have these specific mutations. These results suggest that PARP inhibitors, which are being studied and used in breast, ovarian, and prostate cancers, could have a much broader market than anticipated. (Keshavan, 3/13)
The Associated Press:
FDA OKs New Novartis Drug For Type Of Advanced Breast Cancer
U.S. regulators have approved a new drug as an initial treatment for postmenopausal women with a type of advanced breast cancer. (Johnson, 3/13)