5 ms·

I'm sure there have been many controversial FDA decisions before, but this one seems significantly different. The reactions from normally even-keeled medical jo

by Exmoor 5y ago

I'm sure there have been many controversial FDA decisions before, but this one seems significantly different. The reactions from normally even-keeled medical journalists have been blistering [0] and it's apparently already set a precedent that has resulted in other similar therapies which have also not shown any sign of improving outcomes, starting to be approved as well [1]. [0] https://blogs.sciencemag.org/pipeline/archives/2021/06/08/the-aducanumab-approval https://blogs.sciencemag.org/pipeline/archives/2021/06/08/th... [1] https://blogs.sciencemag.org/pipeline/archives/2021/06/24/open-the-floodgates https://blogs.sciencemag.org/pipeline/archives/2021/06/24/op...

wyxuan 5y ago
Nitpick, I have a great deal for respect for Derek but he isn't a journalist (and nor does he claim to be). It's just a column. But that's not to say the reactions from journalists weren't critical. Adam from Stat had some choice words about the decision.
- pjc50 5y ago
  I'm not sure that's a useful distinction, it's not a chartered profession. Someone who writes a weekly column for money is a journalist in the way that someone who writes software for money is a programmer.
  - eli 5y ago
    There’s a pretty big distinction in the journalism world. It’s more like saying anyone who uses a computer for work is a programmer.
    - dannyw 5y ago
      Yeah, but nobody listens to the guy that calls JavaScript coders "not real programmers" because JavaScript is a 'scripting language'. The point is, it doesn't seem like a useful distinction.
- timy2shoes 5y ago
  My personal opinion: I respect the opinion of a medicinal chemist working in the field of drug discovery more than I do a journalist. The insider who works in the field understands the issues and problems of getting drugs to market more than an outsider.
- mcguire 5y ago
  In other words, it's a column by a guy who spent his career in drug discovery. Not merely a journalist.
  - refurb 5y ago
    Derek always had a well informed take, but asking scientist about a regulatory decision is like asking a engineer about a legal decision. Informed, but not an expert.
  - joe_the_user 5y ago
    Yeah, Derek Lowe is a professional drug researcher who "moonlights" as a popular science writer. If the other drug researchers are sticking necks out to say this is bullshit, it's pretty like that ... this is bullshit. The situation he describes that all the other companies had already failed to their useless drugs approved. Now that one useless drug slips through, all the others are going try and do that.
- ekianjo 5y ago
  what qualifications is a journalism supposed to have? Humanities? when you write about Science having some actual experience doing science is helpful.
ElViajero 5y ago
I hope that the FDA has learned from the U.S. Federal Aviation Administration and the Boeing 737 MAX catastrophy. Credibility is easy to be lost and hard to be gained again.
- Taek 5y ago
  They already have a problem with p-hacking
- ekianjo 5y ago
  The FDA hardly had a good reputation in the first place. The Vioxx fiasco was not too long ago.
  - dnautics 5y ago
    Are you arguing that vioxx should not have been banned? Iirc the FDA did not ban vioxx, it was a voluntary withdrawal.
    - deleted 5y ago
      [deleted]
    - ekianjo 5y ago
      Many deaths linked to Vioxx could have been avoided if the FDA had done its job. Incompetence seems to be a feature of federal agencies.
      - tw04 5y ago
        What job is that? Long term studies showed it’s no more risky than ibuprofen for long term use. I’m not sure there’s a pain killer we’ll ever have that isn’t bad for you when taken in high dosage for years at a time. https://en.m.wikipedia.org/wiki/Rofecoxib https://en.m.wikipedia.org/wiki/Rofecoxib
- forcry 5y ago
  >Credibility is easy to be lost and hard to be gained again. I disagree. If you have media in your team, this is easy, given some time. Particularly in current times when you have a treasure trove of possible distractions that you can make the media throw at a gullible public. If one looks closely, then I think CDC/FDA etc have lost credibility a long time back. The real events portrayed in documentaries like "What lies upstream" and movies like "Dark Waters" should be enough to reject these agencies outright. What is enormously surprising to me is that, not only we consider them very credible, but are also willing to consider their word as unfailable and final in many cases. Even more sad thing is that the power of CDC/FDA extends even to many developing countries, so this affects much more than their home country. [1] https://www.imdb.com/title/tt5165878/ https://www.imdb.com/title/tt5165878/ [2] https://www.imdb.com/title/tt9071322/ https://www.imdb.com/title/tt9071322/
jrochkind1 5y ago
I think the FDA board resignations and general scientist outcry is notable and not routine, but it didn't set the precedent on it's own, it's been a trend long in development. From January 2020 (17 months before aduhelm approved): https://www.npr.org/sections/health-shots/2020/01/14/796227083/fda-approves-drugs-faster-than-ever-but-relies-on-weaker-evidence-researchers-fi https://www.npr.org/sections/health-shots/2020/01/14/7962270... FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find > Almost half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to the study published Tuesday in JAMA, the journal of the American Medical Association. And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment. > …Drugmakers also began paying the FDA fees to fund the review process after AIDS activists protested the agency's sluggishness in the 1980s… "There is some concern about the incentives that this is created within the FDA," Darrow says. "And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry." ["surrogate measures" is a complaint with aduhelm approval, when they say there was no "evidence showing the drug slowed the disease", they mean the approval was based only on surrogate measures.]
- pfisherman 5y ago
  PDUFA and MDUFA (user fees) have no influence on FDA decision making. They are basically pocket change compared to the cost of bringing something on to market. Many think the fees are too low and ought to be increased. Surrogate measures are a trade off that we as a society have decided to make to reduce regulatory burden and accelerate brining new therapies to market. Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently. In some cases it is clear that the surrogate is a good endpoint. In others maybe less so. Regulators have the tough job of balancing the risks, benefits, and science when making the call on whether to accept one. Generally FDA is doing many things to streamline and accelerate the regulatory process. This is good. We want them to innovate and take advantage of new scientific knowledge and technological breakthroughs. Finally I would say that the real precedent for this was the decision for the Duchenne Muscular Dystrophy drug (also happened on Woodcock’s watch). I kind of had this sinking feeling this was about to happen when I saw that she was acting commissioner. Say what you will about Trump, but Gottleib was a damn good appointment - at least until he got fired for going after vaping. Azar was a pussy and basically an empty suit.

by Exmoor 5y ago

wyxuan 5y ago

Nitpick, I have a great deal for respect for Derek but he isn't a journalist (and nor does he claim to be). It's just a column. But that's not to say the reactions from journalists weren't critical. Adam from Stat had some choice words about the decision.

pjc50 5y ago
I'm not sure that's a useful distinction, it's not a chartered profession. Someone who writes a weekly column for money is a journalist in the way that someone who writes software for money is a programmer.
- eli 5y ago
  There’s a pretty big distinction in the journalism world. It’s more like saying anyone who uses a computer for work is a programmer.
  - dannyw 5y ago
    Yeah, but nobody listens to the guy that calls JavaScript coders "not real programmers" because JavaScript is a 'scripting language'. The point is, it doesn't seem like a useful distinction.
timy2shoes 5y ago
My personal opinion: I respect the opinion of a medicinal chemist working in the field of drug discovery more than I do a journalist. The insider who works in the field understands the issues and problems of getting drugs to market more than an outsider.
mcguire 5y ago
In other words, it's a column by a guy who spent his career in drug discovery. Not merely a journalist.
- refurb 5y ago
  Derek always had a well informed take, but asking scientist about a regulatory decision is like asking a engineer about a legal decision. Informed, but not an expert.
- joe_the_user 5y ago
  Yeah, Derek Lowe is a professional drug researcher who "moonlights" as a popular science writer. If the other drug researchers are sticking necks out to say this is bullshit, it's pretty like that ... this is bullshit. The situation he describes that all the other companies had already failed to their useless drugs approved. Now that one useless drug slips through, all the others are going try and do that.
ekianjo 5y ago
what qualifications is a journalism supposed to have? Humanities? when you write about Science having some actual experience doing science is helpful.

ElViajero 5y ago

I hope that the FDA has learned from the U.S. Federal Aviation Administration and the Boeing 737 MAX catastrophy. Credibility is easy to be lost and hard to be gained again.

Taek 5y ago
They already have a problem with p-hacking
ekianjo 5y ago
The FDA hardly had a good reputation in the first place. The Vioxx fiasco was not too long ago.
- dnautics 5y ago
  Are you arguing that vioxx should not have been banned? Iirc the FDA did not ban vioxx, it was a voluntary withdrawal.
  - deleted 5y ago
    [deleted]
  - ekianjo 5y ago
    Many deaths linked to Vioxx could have been avoided if the FDA had done its job. Incompetence seems to be a feature of federal agencies.
    - tw04 5y ago
      What job is that? Long term studies showed it’s no more risky than ibuprofen for long term use. I’m not sure there’s a pain killer we’ll ever have that isn’t bad for you when taken in high dosage for years at a time. https://en.m.wikipedia.org/wiki/Rofecoxib https://en.m.wikipedia.org/wiki/Rofecoxib
forcry 5y ago
>Credibility is easy to be lost and hard to be gained again. I disagree. If you have media in your team, this is easy, given some time. Particularly in current times when you have a treasure trove of possible distractions that you can make the media throw at a gullible public. If one looks closely, then I think CDC/FDA etc have lost credibility a long time back. The real events portrayed in documentaries like "What lies upstream" and movies like "Dark Waters" should be enough to reject these agencies outright. What is enormously surprising to me is that, not only we consider them very credible, but are also willing to consider their word as unfailable and final in many cases. Even more sad thing is that the power of CDC/FDA extends even to many developing countries, so this affects much more than their home country. [1] https://www.imdb.com/title/tt5165878/ https://www.imdb.com/title/tt5165878/ [2] https://www.imdb.com/title/tt9071322/ https://www.imdb.com/title/tt9071322/

jrochkind1 5y ago

I think the FDA board resignations and general scientist outcry is notable and not routine, but it didn't set the precedent on it's own, it's been a trend long in development. From January 2020 (17 months before aduhelm approved): https://www.npr.org/sections/health-shots/2020/01/14/796227083/fda-approves-drugs-faster-than-ever-but-relies-on-weaker-evidence-researchers-fi https://www.npr.org/sections/health-shots/2020/01/14/7962270... FDA Approves Drugs Faster Than Ever But Relies On Weaker Evidence, Researchers Find > Almost half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to the study published Tuesday in JAMA, the journal of the American Medical Association. And the reliance on surrogate measures — stand-ins for presumed patient benefits — has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment. > …Drugmakers also began paying the FDA fees to fund the review process after AIDS activists protested the agency's sluggishness in the 1980s… "There is some concern about the incentives that this is created within the FDA," Darrow says. "And whether it has created a culture in the FDA where the primary client is no longer viewed as the patient, but as the industry." ["surrogate measures" is a complaint with aduhelm approval, when they say there was no "evidence showing the drug slowed the disease", they mean the approval was based only on surrogate measures.]

pfisherman 5y ago
PDUFA and MDUFA (user fees) have no influence on FDA decision making. They are basically pocket change compared to the cost of bringing something on to market. Many think the fees are too low and ought to be increased. Surrogate measures are a trade off that we as a society have decided to make to reduce regulatory burden and accelerate brining new therapies to market. Maybe you disagree with it, but someone with a terrible disease waiting on a new life saving treatment might see the issue differently. In some cases it is clear that the surrogate is a good endpoint. In others maybe less so. Regulators have the tough job of balancing the risks, benefits, and science when making the call on whether to accept one. Generally FDA is doing many things to streamline and accelerate the regulatory process. This is good. We want them to innovate and take advantage of new scientific knowledge and technological breakthroughs. Finally I would say that the real precedent for this was the decision for the Duchenne Muscular Dystrophy drug (also happened on Woodcock’s watch). I kind of had this sinking feeling this was about to happen when I saw that she was acting commissioner. Say what you will about Trump, but Gottleib was a damn good appointment - at least until he got fired for going after vaping. Azar was a pussy and basically an empty suit.