If You Only Read One Thing…
Our friend Robert Goldberg has the must read piece of the day published at Drugwonks. Goldberg connects two issues we’ve been following closely:
- Treatments for patients with melanoma; and
- Memorial Sloan Kettering’s drug price abacus.
For new readers, the Laura and John Arnold Foundation recently announced $4.7 million in grants to the Memorial Sloan Kettering Cancer Center for its “Evidence Driven Drug Pricing Project.” This project’s primary function has been to create a DrugAbacus Tool, which arbitrarily sets its own value for treatments.
Goldberg points out in his blog post the inherent flaws with a drug abacus tool.
“The reliance of the Abacus for indication specific pricing pre-empts a more ethical approach to treatment selection,” Goldberg writes. “The Abacus accepts the one size fits all survival response when genetic and tumor variation affects outcome. The Abacus ignores the fact that better information of the variation in patients and treatment response translates into more life years and better quality of life.”
And here’s the kicker: “The Abacus completely ignores that many medicines are used in combination to treat melanoma.”
A drug abacus or value tool that ignores the total treatment approach undercuts patients. Who benefits from the Abacus’ pricing model? You’ll have to read Goldberg’s entire piece.
State Spotlight: New Jersey
A bill moving its way through the New Jersey State Assembly would cap prescription copays for a third of insured Garden State residents. Assembly Bill 2337 would set caps for silver and gold and platinum plans at $100 and $200 per month, or a 30-day supply for bronze plans. NJTV News Anchor Mary Alice Williams recently interviewed the bill’s author Assemblyman Daniel Benson.
Benson raises an important concern that insurance companies are intentionally raising co-pays to deter patients from selecting the higher level plans.
“You’re seeing some insurance plans … pricing them so high people simply choose not to take the drugs and thereby reducing the costs to the plan,” Benson told NJTV. “Unfortunately, patients are the ones caught in the middle and that’s why my legislation would restore kind of sanity to what those prices are.”
Campaign 2016: Tough Regulation Sparks Innovation?
Matthew Herper, writing at Forbes.com, argues that GOP presidential candidate Ted Cruz is wrong about his assessment of the FDA. Herper believes that “Tough Regulation Can Spark Innovation.”
“What Cruz, and most FDA critics, miss is that there is a delicate balance to what the FDA does,” he explains. “True, tough regulations stifle innovation, keeping innovators from even trying.”
Count us among those that believe the FDA’s regulatory framework impedes innovation. But, our central goal is the best interests of patients. To achieve that end, we’re always willing to consider opposing views. What’s Herper’s case?
“Sometimes, breakthroughs happen because the FDA demands them. Like what? The first diabetes drugs ever shown to prevent heart attacks and strokes, for one. Last November, results were published in the New England Journal of Medicine showing such a benefit for Jardiance, from Eli Lilly and Boehringer Ingelheim . Last week, Novo Nordisk announced that its Victoza also prevented the combined endpoint of heart attacks and strokes.
It’s likely neither of these studies would have even been run had it not been for FDA–and controversy. In 2007, Steven Nissen, the chairman of cardiology at the Cleveland Clinic, was on the warpath. He’d raised concerns that Avandia, at the time the most widely used diabetes pill in the world, actually caused heart attacks.
Nissen’s proposal: If a company wants to sell a diabetes drug, it needs to do a study to try and prove that the drug reduces heart attacks and strokes. Even if the study fails on that goal, it’s likely to show that the drug is safe. Industry representatives initially rejected to the idea, but it got a major boost when Nissen’s rival, Duke cardiologist Robert Califf, also supported it. Califf is now the FDA’s commissioner.”
Herper certainly raises a good point, but it’s largely the exception that proves the rule. There’s no question that the regulatory approval process can be streamlined without compromising patient safety. And that’s ultimately what the FDA’s operating philosophy should be: what’s in the best interest of patients.
Privacy Concerns with Health Apps
Reuters Health’s Lisa Rapaport shares privacy concerns with the growing number of health apps available on smartphones and tablets.
“Just because a health app has a privacy policy doesn’t mean the data will remain private, an analysis of mobile tools for diabetes suggests,” Reuters notes. “In fact, privacy policies appear rare, and when they do exist, most state that user data will be collected and half warn that medical information will be shared with third parties.”
The privacy concerns come from a new study authored by Sarah Blenner, a public health researcher at the University of California, Los Angeles. She looked at 211 apps available for download in Google Play. The data is frightening:
- Only 41 apps had any privacy policy at all
- Only 4 apps explicitly asked users for permission to share data
- 16 apps used data for advertising purposes.
This piece is a great reminder to patients: Always check the privacy policies anytime your personal health information is shared with anyone or any device.
