House Bill Would Cut NIH Spending Boost
GOP leaders released an updated version of the medical cures bill just before the long weekend that slightly reduces a funding increase for the National Institutes of Health. Meanwhile, the implications of FDA approval of a costly cystic fibrosis treatment are explored. Other stories look at FDA approval of a new blood test developed by Theranos and the agency's plans to investigate codeine cold and cough drugs for children.
The Hill:
House Bill Reduces Spending Boost For NIH
House leaders on Thursday released an updated version of a medical cures bill that slightly reduces a funding increase for the National Institutes of Health. The latest changes to the bill were posted on the House Rules Committee website just before the long weekend, as well as floor consideration of the bill next week. The bill’s bipartisan backers have been working out its $12 billion in offsets. (Sullivan, 7/2)
The Wall Street Journal:
Vertex’s $259,000 Cystic Fibrosis Drug Gets FDA Approval
The U.S. Food and Drug Administration approved Vertex Pharmaceuticals Inc.’s cystic-fibrosis drug Orkambi, which could treat as many as 8,500 patients in the U. S.—but at a whopping annual wholesale cost of $259,000 per patient. ... The drug is the latest to carry a potentially budget-busting price tag. Others are for cancer and hepatitis C. (Armental and Burton, 7/2)
The Washington Post:
Are Risks Worth The Rewards When Nonprofits Act Like Venture Capitalists?
But frustrated that no game-changing treatments were in sight, the [Cystic Fibrosis Foundation's] leaders in 1999 placed what many considered a risky bet, deciding to invest millions of dollars in a small California biotech firm. ... That initial bet, which over time grew into a $150 million investment, has paid off in a big way. It led to the approval in 2012 of a breakthrough drug — the first that treats the underlying cause of cystic fibrosis rather than the symptoms, in a small subset of patients. On Thursday came another big win: The Food and Drug Administration approved a second drug for the group also helped fund development; that drug eventually could aid roughly half of the 30,000 cystic fibrosis patients in the United States. (Dennis, 7/2)
The Washington Post's Wonkblog:
The Untold Story Of How Today’s Fight Over Vaccines Has Its Roots In The American Revolution
Debates over public health and personal liberty can seem utterly of the moment in response to new and evolving threats -- an outbreak of measles at Disneyland this year triggered California politicians to put the law forward. And remember when the scary specter of Ebola triggered some politicians to implement mandatory quarantines for physicians and nurses who traveled to Africa to treat Ebola patients -- over the objections of public health experts? But a flashback to our nascent nation in the summer of 1776 -- when liberty was pretty much the topic of the day -- can reveal just how long the debate over government health policies has been running, and how the meaning of "freedom" has changed when it comes to access to preventive medicine. (Johnson, 7/2)
The Washington Post:
Theranos Blood Test: The Insanely Influential Stanford Professor Who Called The Company Out For Its ‘Stealth Research’
When Theranos chief executive Elizabeth Holmes announced Thursday that her company's finger-stick blood test had won clearance from the Food and Drug Administration the outcome of the review wasn't the news. It was that she had gone to the FDA in the first place. Holmes' company, a Silicon Valley darling estimated to be worth $9 billion, has been poised to upend the blood business since it began offering its tests to the public in 2013. With just a few drops of blood, its technology can reportedly scan for dozens of disease and conditions near instantaneously. But for a company that has received so much attention, there has been surprisingly little information about how its technology works and the company has maintained -- and still maintains -- that it is not required to seek regulatory approval for its products. (Cha, 7/3)
CNN:
FDA To Evaluate Risk Of Codeine Cough And Cold Meds For Children
The Food and Drug Administration says it will take a closer look at cough and cold medicines for children that contain codeine.
"We are evaluating all available information and will also consult with external experts by convening an advisory committee to discuss these safety issues," says an announcement posted Wednesday on the FDA website. (Goldschmidt, 6/2)
Meanwhile, research is underway looking at whether insulin could prevent diabetes and the New York Times examines the enduring popularity of a generic diet drug -
The Associated Press:
Could Insulin Pills Prevent Diabetes? Big Study Seeks Answer
For nearly a century, insulin has been a life-saving diabetes treatment. Now scientists are testing a tantalizing question: What if pills containing the same medicine patients inject every day could also prevent the disease? ... Hayden Murphy is among more than 400 children and adults participating in U.S. government-funded international research investigating whether experimental insulin capsules can prevent or at least delay Type 1 diabetes. Hospitals in the United States and eight other countries are involved and recruitment is ongoing. To enroll, participants must first get bad news: results of a blood test showing their chances for developing the disease are high. (Tanner, 7/3)
The New York Times:
Top-Selling Diet Drug Phentermine Is Cheap And Easy To Get
The Food and Drug Administration has approved several new weight-loss drugs in recent years, but the best-selling diet pill in America isn’t among them. That title belongs to phentermine, a generic drug that has been around for decades and has managed to hold its own despite the arrival of new competitors. The drug is viewed as effective and relatively safe to help jump-start diets in patients who are obese. However, phentermine — a stimulant that can give users an inexpensive high — has a long history of misuse. It has also frequently flown under the radar of regulators, who tend to focus their resources on deadlier drugs like opioid painkillers. (Thomas, 7/4)
The St. Louis Post-Dispatch:
Mallinckrodt Takes On FDA In Fight Over ADHD Generic
In November, the U.S. Food and Drug Administration gave Mallinckrodt Pharmaceuticals an ultimatum: Either prove its generic version of a popular drug was the same as the brand name, Concerta, or voluntarily remove it from the market. The FDA gave the drugmaker, which has U.S. headquarters in Hazelwood, six months to make either move. But time is up and its drug, which is used to control the symptoms of attention deficit hyperactivity disorder, or ADHD, is still on the market. (Liss, 7/3)
