The well-known oncology researcher José Baselga has resigned his position as Chief Medical Officer at Memorial Sloan Kettering after an NYT/ProPublica investigation showed he failed to disclose millions in payments from pharma and healthcare companies in dozens of his research articles. The payments themselves aren’t at issue, it’s the fact that he didn’t make his ties explicitly known. Which is kinda funny since those financial reporting rules were set by the American Association for Cancer Research while he was president of the group. Critics say Baselga’s fall illustrates the bigger problem of the revolving door between academic research and industry, as well as a general laziness towards enforcing ethical standards from the academic community. Expect a rush of researchers who ‘forgot’ to include their financial ties in previous papers to quietly go add those in.
Treating Alzheimer’s has been a major issue for researchers, considering clinical trials that aim to treat the condition fail at a rate of 99.6 percent. Anything shown to remotely help will lead to big investments, as Biogen and Eisai learned on Thursday when they released positive results on their IND BAN2401. It’s not just a big deal because it could lead to a treatment, but also because it provides evidence we’ve figured out how the condition works. We think Alzheimer’s progresses from amyloid plaque accumulating between neurons, disrupting cell communication. The drug candidate doesn’t clean the plaque up, but it does clean up the cell clusters that form the plaque. Let’s hope this avenue of research provides more answers so we don’t end up spending $1 trillion on the condition by 2050.
Big topic for a short article but here’s the skinny… you receive a scan for some legitimate reason in the course of receiving health care. Scientists and companies use your images—stripped of all personally identifying information—in the development of artificial intelligence that is able to diagnose disease. These people and companies make gobs and gobs of money. Are you owed compensation because their commercial product could not have been developed without using “your” scans? This is somewhat different—it could be argued—than the famous case of Henrietta Lacks, whose live cells were used and commercialized. (By the way, she also got no money.) These are just scans. Ones and zeros, right? Here is a more complete report from NPR, with modern-day cases. Let InsightCity know what you think in this week’s FastPoll™.
Another week, another regulation question. Should there be a law that forces innovators to provide samples for research to generic drug developers?
Listen up, innovators. FDA head Scott Gottlieb is sick of your games (live footage here.) Specifically, he’s sick of companies that won’t provide samples of their products to generic producers, which slows down their research into developing a cheaper alternative. This essentially boils down to a non-patent-based approach to maintaining market exclusivity, and it looks like it won’t be tolerated for much longer. Not only is the FDA sounding off on the practice, but so is the FTC and even Congress. Innovators argue that regulation isn’t needed, considering the FDA approved a record number of 1,027 generics last year. The agency shot back saying it’s received over 150 inquiries from generic companies who couldn’t get the samples they needed. So what is the truth?
Antibiotic resistance is one of the most urgent issues affecting healthcare, costing thousands of lives and billions in medical costs each year (click here for the CDC’s list of the scariest strains.) It’s an annoying problem. R&D produces a new antibiotic and within some years the little buggers have already figured out how to not get killed by it (very sick video of that process here.) Well at least we have a new weapon that they might have some trouble fighting against. Malacidin is a distant relative of a newer antibiotic called daptomycin which up until now has evaded bacterial resistance. While discovering a new antibiotic is immediately cool and helpful, discovering a class that can avoid being useless after its introduction would be huge.
What is “it,” you ask? Spark Therapeutics’ new gene therapy Luxturna which can cure blindness in a single treatment. The condition causing the blindness only affects a few thousand people, so the FDA has designated it as an orphan drug. The single dose and orphan drug aspects of this gene therapy combine for a rather expensive R&D bill, and translate into a bit of sticker shock at the selling price: $425,000 per eye. Spark is trying out some interesting commercialization practices to get the drug to patients, like giving rebates to patients whose eyes don’t see better over time. They’re also considering selling the therapy directly to insurance companies so that health care providers don’t have to pay and store the treatment without a guarantee it’ll ever be used.