June 06, 2019
Situational awareness: Opioid manufacturer Insys has agreed to pay $225 million to settle federal investigations into allegations that it illegally marketed its fentanyl spray, AP reports.
Today's Vitals is 721 words, <3 minutes.
1 big thing: Scientists concerned with fetal tissue ban
The Trump administration announced yesterday that it will no longer fund medical research that uses fetal tissue, drawing the ire of scientists and research groups.
- It will also end a multi-million dollar contract with a lab at the University of California, San Francisco that uses fetal tissue to test new HIV therapies.
- "Promoting the dignity of human life from conception to natural death is one of the very top priorities of President Trump’s administration," HHS said in a statement.
The National Institutes of Health funds about 200 external research products that use fetal tissue, which will be unaffected. There are only 3 NIH-run projects that will be impacted.
- Future grant applicants will be reviewed by an ethics advisory board.
What they're saying: While the move is supported by anti-abortion advocates, scientists say it's an impediment to finding new medical treatments.
- The new rules "further erode the unique potential fetal tissue research holds for addressing such critical objectives as fighting blindness, ending Parkinson's Disease, and advancing maternal and child health," Research!America said in a statement.
- "Valuable research that is directed at helping to develop therapies for terrible diseases will be stopped," Larry Goldstein, a distinguished professor in the University of California, San Diego, told the Washington Post.
While scientists say that there is no equally effective alternative to fetal tissue in research, opponents of its use say that some newer methods show potential, the Post reports.
2. Congress considering making pharma pay up
Senate Finance Chairman Chuck Grassley said yesterday that drug and insurance companies should cover more of seniors' drug costs.
- Grassley wants drugmakers to pay more of the bill in Medicare Part D's catastrophic phase. Taxpayers bear most of those costs now.
"There's an incentive for the insurance companies and for the pharmaceutical companies to get people into catastrophic very soon... We want to take away that incentive by having the insurance companies and the pharmaceuticals pay a greater part of the cost," Grassley said at an Axios event.
- He also said that he wants to cap seniors' out-of-pocket expenses.
A lot of experts agree with Grassley and say that Part D's incentives need to be reworked.
My thought bubble: The drug industry lobbied hard against a change to Part D last year that made pharma pay more to close Part D's "donut hole." Paying for part of the catastrophic phase would likely cost them even more.
3. Opioid prescriptions declining
Here's some rare good news regarding the opioid epidemic:
- Opioid prescriptions are down, naloxone prescriptions are up and doctors are increasingly using state prescription drug monitoring programs, according to the American Medical Association's 2019 Opioid Task Force Progress Report.
By the numbers: Queries made to state PDMPs increased by about 650% between 2014 and 2018. That means doctors are checking patients' prescription history before giving them more opioids.
- Prescriptions for naloxone — the opioid overdose reversal drug — increased by about 340% between 2016 and 2018.
Yes, but: While the medical community has become deeply engaged in combating the epidemic, illegal drugs like heroin and fentanyl have replaced prescription opioids as the main cause of opioid deaths.
4. Another diagnostic company data breach
A second lab diagnostic company has disclosed that the data of millions of patients has been hacked, Bloomberg reports, meaning about 20 million people have had their health care data compromised.
- Both diagnostics companies — Laboratory Corporation of America Holdings and Quest Diagnostics — use American Medical Collection Agency, which they say is the source of the breach.
The data compromise has drawn the attention of Sen. Mark Warner, a cybersecurity advocate.
- "I am concerned about your supply chain management, and your third party selection and monitoring process," Warner wrote in a letter to Quest.
- AMCA says that it is investigating the breach and has involved law enforcement.
5. Group requests FTC look into biosimilar market
A patient advocacy organization sent a letter yesterday to the Federal Trade Commission asking it to investigate industry behavior that hinders biosimilars from competing with biologics.
- The letter references Axios' reporting on UnitedHealthcare's decision to disadvantage Coherus's Udenyca, a biosimilar, against Amgen's Neulasta, the biologic drug it's competing against.
- Amgen offered United a bigger rebate than Coherus did.
What they're saying: "We will not have a viable biosimilar market if brand drug companies are able to pay huge kickbacks to PBMs and insurers to block biosimilar uptake," the group, Patients For Affordable Drugs Now, wrote in the letter.
- It asked the FTC to investigate the United deal as well as these types of agreements more generally.