Good morning. I hope you enjoyed your weekend.
1 big thing: The complicated politics of Trump's rebate rule
The Trump administration's proposal to shake up how money moves through the prescription drug supply chain in Medicare works best if it's also extended to the commercial market, supporters say.
Yes, but: The politics of the proposal will almost certainly prevent this from happening. Opponents say the change is a handout to pharmaceutical companies and would increase premiums.
The big picture: The Trump administration has proposed eliminating in Medicare Part D the rebates that drug companies pay to pharmacy benefit managers in exchange for preferred formulary placement.
The administration doesn't have the authority to extend the rule into the private market, leaving the decision with Congress. But supporters say doing so not only would help patients, but would create a stronger incentive for drug companies to lower their list prices.
- "Clearly [drug companies] would face a lot more [pressure] if this was extended to the commercial market," former FDA Commissioner Scott Gottlieb said.
Yes, but: The independent Congressional Budget Office estimated that the administration's proposal — which is limited to Part D — would cost the federal government $177 billion over 10 years, an eye-popping price tag that is giving members of Congress pause.
- Critics say the proposal is a handout to drug companies, which won't be required to lower list prices. They also point to the very real possibility that it would raise premiums.
What they're saying: Drug companies have said publicly that they're more likely to lower list prices if the proposal extends to the commercial market.
- "It will be important to have any rebate reform apply to both government programs and the commercial market...A bifurcated market will make it more challenging for manufacturers to reduce list price," wrote Pfizer CEO Albert Bourla in a response to the Senate Finance Committee.
2. Memory supplements come under scrutiny
The big picture: The business of memory supplements — from branded regimens to vitamins — pulled in $3.2 billion globally in 2016.
- 48% of people ages 50–64 in the National Poll on Healthy Aging reported taking a vitamin or supplement to help their memory.
- "People are willing to pay and do anything to preserve their brains ... but we don’t have the knowledge yet to give really effective interventions that change that trajectory as much as people think," said Joanna Hellmuth, a neurologist at the University of California, San Francisco.
- "The problem is that a lot of the interventions being marketed directly to consumers don’t do rigorous studies of the outcomes," said Hellmuth, who recently wrote about the "rise of pseudomedicine" for brain health.
- There are also questions about the safety of supplements, the Wall Street Journal reports.
- The Food and Drug Administration recently cited 17 companies for illegally selling products "that claim to prevent, treat or cure Alzheimer's disease and a number of other serious diseases and health conditions."
3. A new approval for an old blood thinner
The FDA gave the OK last week for Pfizer's blood thinner Fragmin to be used in children. But Fragmin is not new — it has been on the market for adults since 1994, my colleague Bob Herman reports.
Why it matters: This is another case of an older drug getting broader approval with limited evidence.
- "The efficacy of Fragmin in children was based on a single trial with 38 pediatric patients," the FDA said.
Between the lines: Fragmin is a relatively small medication for Pfizer, generating $293 million in sales in 2018, down from when sales were about $382 million in 2011. But getting an expanded approval will immediately create a return for Pfizer because the drug is still the same product — now with a bigger population to treat.
Go deeper: "Almost half of all new drug approvals in 2018 relied on one clinical trial," Zachary Brennan of RAPS Regulatory Focus reports.
4. The downside of the genetic testing boom
Genetic testing is advancing and evolving so quickly that it's causing chaos for some patients, WSJ reports.
- Patients may receive one diagnosis and begin treatment, only to receive a different diagnosis a few years later through more advanced testing.
Why it matters: Genetic testing and the medical breakthroughs it's led to are good things. But the WSJ's reporting highlights that actually living through these rapid scientific advances can be challenging and emotional.
Details: Commercial testing spiked after scientists successfully sequenced the human genome in 2003. A study last year found that there are about 75,000 genetic tests that are used by doctors on the market.
- Another study done by researchers at the University of Texas Southwestern Medical Center found that, out of more than 300 epilepsy cases, nearly a third of the children had a change in diagnosis because of the emergence of new genetic data.
5. While you were weekending
- Axios' Eileen Drage O'Reilly gives an overview of what hasn't worked in the search for a treatment for Alzheimer's, and the approaches that scientists are taking now.
- Business Insider has another damning story about uBiome, this time reporting that cofounder Jessica Richman lied about her age to reporters so that she'd be included in stories about young founders. She and cofounder Zachary Apte may have also been in a romantic relationship.
- Citrus farmers' use of antibiotics to combat bacteria that is killing their crops has health officials worried about the rise of drug-resistant infections, NYT reports.