And if you can trick the drug into saying that, it gets sent back to the 5th dimension.
@DesertDog I did ace it, but that’s due to practicing medicine for over 3.5 decades, and obsessively reading everything JRRT wrote about middle earth for even longer. A life well spent . . .
Forgive me for ‘just’ posting a link, and for stating the obvious, but for any who don’t understand the ‘why’ here (ie, “Who profits ?”), it isn’t just the drug company.
It’s also the regulatory body that they bought and pay for every year (they profit by being allowed to survive, financially):
The agency, whose responsibilities include making sure that prescription drugs sold in the United States are safe and effective, receives almost three-quarters of its funding for that work from drug makers. In Fiscal Year 2015, the agency spent about $1.1 billion on prescription drug oversight—more specifically, those activities the agency categorizes as part of its “process for the review of human drug applications.” Congress delivered 29 percent of that money—$331.6 million. Drug companies provided the rest—$796.1 million.
Over the past two decades, “user fees” paid by industry have climbed from 35 percent of the FDA’s spending on such oversight to 71 percent.
And that’s putting aside the DTC (Direct To Consumer) advertising that drug companies can only do in the US and New Zealand, the two countries who top the chart for the number of prescription meds each adult citizen takes.
And how often do drugs that don’t work as expected, and then don’t perform economically as expected (no work-y often = no prescribe-y) become the center of allegations, investigations, charges, and leviathan settlements for fraudulent marketing practices by the drug companies ?
Hmm.
Yeah. We just suck.
I have mixed feelings about this. The way Biogen has handled this looks sketchy, and the cost is insane. Seeing the price tag brought up visions of Martin Skreli’s grinning face.
On the other hand, I’ve been through multiple experiences of the horror of watching Alzheimer’s hollow out people minds. Like my father-in-law wandering around and asking where his wife was, and having to tell him—again—that she’d been dead for years. Or my dad returning home from a visit with his mom, and being depressed because she didn’t recognize him … and seeing exactly the same thing happen to him twenty years later. In another twenty years or so, that’s going to be me.
Would I take an Alzheimer’s drug that has a very limited chance of working and a possibility of some really scary side effects? You bet I would. You better believe I would. Sign me up.
Only if Medicare covers it. If it doesn’t, then desperate patients might choose to pay out of pocket for the treatment. So imagine someone paying for this treatment for several years, pissing away their nest egg for (probably for minimal benefit) - and in the end, lacking the funds to pay for the long-tern care they are still going to eventually need, meaning the cost falls to Medicaid. That doesn’t sound like a good deal for anyone.
Agreed- but there’s a massive lobbying effort going on. Because I work on this stuff, my targeted ads in Chrome are inundated with ads from the Alzheimer’s association’s advocacy group’s efforts to get this (and the scanning) covered. And the AARP crowd is a powerful voting bloc.
Yeah, if there was ever a game right up your alley, this would be it.
And the exact opposite: Convicted male sex offenders are sometimes offered more lenient treatment if they agree to take regularly a drug which nullifies their sex urges, or “feminizes” them. The leading candidate drug being mycoxafloppin.
So…which one helped more…?
(And I do spend time looking up names of prescription drugs when I Dungeon Master games - its a true treasure trove.)
It was pretty equal, frankly.
My paternal grandmother died of Alzheimer’s. My father had it too. I’ve never actually sat down and worked out the odds that I’ll get it. But, I know they are much higher than average. I stand firmly with Qadgop and OldOlds False hope and snake oil are bad bad things. They are worse when they are hugely expensive. I’m very disappointed in the FDA
That’s too funny! Have you had anyone else “get it”?
You beat me to it! That was one of the funniest things I’ve ever seen on television, even though 95% of the audience wouldn’t have fully gotten it.
Not directly relevant to this thread–and if this is threadjacking feel free to delete with my apologies–bit there is a scheme to many of these names:
Kind of interesting if you’re into words and etymologies.
Of course, I made her for a game I was playing with my youngest kid (21 years old) and my husband. They both think its hilarious (although the youngest rolls their eyes because inappropriate parental humor). My husband things she should be Sildenafil Everwood. (And she really should be a he, but I do male representation poorly in role playing)
A drug was OKd to help female libido. The drug company sold it to a bigger company for $1 billion. It does not really work so it did not sell. . The company that bought it gave it back to the original drug company for free.
Obviously I haven’t seen the agreements, but generally when you take on a drug under license, you have to meet certain development and sales milestones. There will typically be a clause that if you aren’t able to meet milestones then the developer takes back the license. It’s not a sign of a good deal, at least for the licensee. I just point this out because they were probably faced with large payments to the licensor if they didn’t give it back, and decided to cut their losses.
The libido drug was barely approved I think by 1 vote.
It seems to me that, in some ways, all of these objections get to the underlying point that I was trying make, which was not just about this particular drug, but about the role of the FDA as the gatekeeper and stamp of approval in the American pharmaceutical system.
Let me get one thing out of the way first. I’m not some sort of radical libertarian who believes that government should just get out of the way and let private enterprise do what it wants. In fact, I generally describe myself as a sort of updated New Deal Democrat. I think that we need a good public health system, and coverage for all Americans, and I also believe that there needs to be regulation and oversight of pharmaceuticals so we don’t end up with the patent “medicine” quackery that proliferated in America before the 20th century.
But while I think there needs to be oversight and regulation, it seems to me that the United States, in some of its government agencies like the FDA, suffers from the worst of both worlds in its efforts at regulation: the regulatory body often slows down innovation and delays the release of beneficial products, while also being subject to regulatory capture by the very industry that it’s supposed to be regulating.
Take the point made by @OldOlds, above. This responsibility you talk about, where “companies are on the hook for whatever happens with their drug during the clinical phase,” is something imposed by the FDA. If the regulatory agency adopted an approach that emphasized full disclosure rather simple “yes or no” approval, drug companies might be more willing to allow people early access to their products. The reason that the drug companies don’t do it now is not because they don’t want to test their drug in real-world conditions, but because the regulatory risks of allowing the testing are too high.
Something similar could be said about @Hari_Seldon’s point about the fact that a new drug would “have to be tested against this drug rather than a placebo.” Again, that’s not something that’s inherently true of medical research; it’s a condition imposed by the regulator.
And @Qadgop_the_Mercotan, your invocation of the Hippocratic Oath in this case is not especially convincing as an argument about drug approval. It is doctors, the people who actually treat patients, who take the Hippocratic Oath. And, at least as I understand it, doctors are supposed to follow the “do no harm” principle under all circumstances, whether or not the FDA has given its imprimatur to a particular drug. If the FDA approves a drug but you, as a physician believe that it has “no clear benefit while having clear risks,” then it’s your responsibility not to prescribe this drug for your patient. It seems to me that your argument here is basically blaming the FDA for the choices made by medical practitioners. And it seems to me that, if doctors treat the FDA as the arbiter and gatekeeper, not only of what drugs they can’t prescribe, but what drugs that should prescribe, then maybe that’s another problem with the regulatory structure and its relationship with the practice of medicine in the United States.
Look, I don’t claim to have easy answers. Since yesterday I’ve been doing a bunch of reading about Aducanamab, and it certainly seems that the criteria used by the FDA to approve the drug were problematic, at best. But it also seems to me that, in cases like this, the discussion needs to be about more than “Did the FDA make the right decision in this case?” The discussion needs to be about the very structure and procedures and legal framework of the whole regulatory system.
Modding (
) That’s a capital offense.