Thumbs Up/Down

Thumbs Up/Thumbs Down: The UN fumbles badly over access to drugs while developers think again about R&D strategies



Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.

thumb down  The UN has a terrible idea for resolving the drug pricing issue

The brouhaha over drug prices this year has now helped stir up one of the worst proposals we’ve heard of so far. This one comes from the UN, which we occasionally forget exists at all. The problem with drugs, says the UN, is that all that nasty IP used by biopharma companies to control these products is allowing them to price therapies beyond the reach of the poor. The US and other countries should do what they can to demand ready access to the drugs taxpayers help provide research support for, says the UN. We beg to differ. Any solution regarding drug pricing is going to have to be market-based, unless you just want to destroy the market. If you destroy the market, there aren’t going to be many drug prices to fight over, because we’ll have far fewer therapies. There are market-based initiatives — let’s all applaud Brent Saunders on that score — which can go a long way to resolving this debate. Manufacturers, we note, have also been going a long way to develop pricing structures for each economy. As for the UN, it might want to find another crisis to address. They’re already irrelevant on the drug pricing debate.

thumb New revelations from genetics research help drive a new approach to R&D

Eisai’s new research group in Andover, MA, which we covered this week, illustrates once again how drug development has been undergoing a major revamp. Groups like this promise to start with a clean slate and build new drugs from the ground up, doing more with fresh revelations about genetics to crack some very difficult targets like Alzheimer’s. We may eventually find ourselves with a few bad-to-mediocre drugs for this disease, plucked out of the current late-stage crop, but a clean-slate approach offers a much better shot at making a meaningful difference for patients. Denali, run by some ex-Genentech execs in San Francisco, is on the same track. Yes, this will all require years of exploration and plenty of missteps along the way, but the ultimate payoff will likely be well worth the wait.

thumb down In the absence of news on eteplirsen, we’re left with tea leaves

In the absence of an FDA decision, we’re all left reading tea leaves when it comes to covering Sarepta. This week it was the news about Ron Farkas’ departure from the FDA that provided the basis for a fresh round of speculation about their Duchenne muscular dystrophy drug. Advocates who booed Farkas’ harsh criticism of Sarepta’s case for this drug saw it as a big win. Skeptics didn’t see how one regulator’s exit could make much of a difference. We’ve been waiting for the FDA to make up its mind on this drug, and the tiny study used to back up its case for an accelerated approval, all year long. It’s time for the FDA to stop dithering and make a decision. Patients need to know where the agency stands on this.

thumb down Stat will need to back up its next slapdown in biotech

I’ve been covering biopharma for a long time, and jumped into journalism close to four decades ago. If there’s one thing I’ve learned, if you want to really expose a badly run company, you had better be able to establish the facts. Stat, an online publication which has done much worthy work, claimed it had the goods on Moderna, but woefully failed to deliver. The opening paragraphs of that story promised explosives, and it delivered a few firecrackers. And most, if not all, of those firecrackers were thrown by anonymous critics. Stat unfortunately dispenses with standards when it wants to stir up a controversy. Next time, they should do the hard work, in the way that the Wall Street Journal demonstrated with its coverage of Theranos. We’re waiting.

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