An FDA Quality-Control Nightmare With Carcinogen-Tainted Drugs Reveals Weak Spots In Federal Regulation System
The FDA has a rigorous approval process for new drugs--companies conduct clinical trials in humans over several years to prove a drug is safe and effective. But 90% of all medications prescribed to Americans are generics. They’re cheaper, they’re supposed to work the same way, and they receive less scrutiny right from the start. In other pharmaceutical news: a look at why there aren't better cancer drugs; the trouble with capping insulin prices; hidden secrets about a baldness drug; and more.
Bloomberg:
How Carcinogen-Tainted Generic Drug Valsartan Got Past The FDA
The chemical N-Nitrosodimethylamine, or NDMA, is a yellow liquid that dissolves in water. It doesn’t have an odor or much of a taste. It’s known to cause cancer in animals and is classified as a probable carcinogen in humans—it’s most toxic to the liver. A single dose of less than a milligram can mutate mice cells and stimulate tumors, and 2 grams can kill a person in days. An Oklahoma man poisoned the family of an ex-girlfriend in 1978 by pouring a small vial of NDMA into a pitcher of lemonade. In 2018 a graduate student in Canada sickened a colleague by injecting the chemical into his apple pie. (Edney, Berfield and Yu, 9/12)
The New York Times:
Why Aren’t There Better Cancer Drugs? Scientists May Have Picked The Wrong Targets
Twenty years ago, the fight against cancer seemed as if it were about to take a dramatic turn. Traditionally, cancer doctors fought the disease with crude weapons, often simply poisoning fast-growing cells whether they were cancerous or healthy. But then a team of researchers hit on a new strategy: drugs targeting proteins produced by cancer cells that seemed necessary to their survival. (Zimmer, 9/11)
Stat:
Study Suggests Explanation For Why So Many Cancer Drugs Fail
Jason Sheltzer thought he was learning answers to a simple question, but one that, for cancer patients, could mean the difference between life and death: Which genes can’t tumor cells survive without? Identifying DNA that seems essential to cancer cells’ survival tells drug developers which genes or gene products to target — a tried-and-true approach that has led to such lifesaving cancer drugs as Herceptin. (Begley, 9/11)
Colorado Sun:
Critics Worried Colorado’s New Law Capping Insulin Costs Would Raise Insurance Rates. It Hasn’t.
When Colorado earlier this year became the first state in the country to cap the price that some people will pay for insulin starting next year, skeptics questioned whether the change would raise insurance prices for everybody else. The answer, according to regulatory filings from insurance companies, is no. The Colorado Sun reviewed the documents that 21 health plans submitted to the state Division of Insurance to justify their proposed 2020 rates for the individual and small-group markets. Most plans didn’t mention the insulin caps at all as being a factor in their calculations. (Ingold, 9/11)
Reuters:
Special Report: Court Let Merck Hide Secrets About Baldness Drug's Risks
By the time Kelly Pfaff got home from driving her son to school that morning, it was too late. Her husband, John, was supposed to be taking their 4-year-old daughter to school. But the girl and the nanny were still at the Pfaffs’ house near San Diego. So were John’s wallet, cellphone and wedding ring. John was gone. (9/11)
Kaiser Health News:
Congress Rakes In Millions From Drugmakers
Members of Congress raked in almost $4 million from pharmaceutical manufacturers and their trade groups in the first six months of 2019. Two members — Sen. Chris Coons (D-Del.) and Sen. Thom Tillis (R-N.C.) — each received over $100,000. Rep. Greg Walden (R-Ore.) is $5,000 shy of qualifying for the “million-dollar club,” a group of current members who’ve received $1 million or more since 2007. (Lucas, 9/12)
