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FDA Approving Drugs at Breakneck Speed, Raising Alarm
- qrbLPHiKpiux 7y agoDoc here. I was at a continuing education course last year. FDA approved a new narcotic very fast. A non narcotic alternative is taking forever to approve. Its name is Maxigesic. Tylenol and ibuprofen in one pill. Why?
- dickeytk 7y agoWhat do you think the reason is? I only ask because there are (probably) few Doctors here and it's an interesting question.
- burpsnard 7y agoYes.. fda approves combination pills seperate to each drug on it's own. While i'm not a pharmacologist, it dies seem odd
- acd10j 7y agonot a doctor, I for one will prefer a single pill instead of two pills , Swallowing pill is unpleasy for me, if there are too many pills , There is higher chance of mistakes (like forgetting, mixing doses etc) .I will pay a reasonable premium for one combination pill instead of two pills.
- merpnderp 7y agoThat’s very strange. People have been alternating/mixing Tylenol and Ibuprofen for nearly 60 years. Don’t we know how they interact?
- Cougher 7y agoYes we do. People see the equation as drug + drug = relief. Pharmaceutical companies see the equation as drug + drug + patent = $
- ensignavenger 7y agoI don't know about this drug, but they may be using a different manufacturing process or something else that is undergoing scrutiny.
- qxnqd 7y ago>Maxigesic. Tylenol and ibuprofen in one pill. What's the point of this, compared to just having half a pill of tylenol and half a pill of ibuprofen?
- iudqnolq 7y agoIf anyone reads this for medical advice (and I really hope they wouldn't be taking advice directly from HN without any filtering), you don't combine them in equal proportions.
- selectodude 7y agoYes, you combine 500mg of acetaminophen and 150mg of ibuprofen. Ibuprofen only comes in 200mg pills, so if you want to be really spot on, take the liquid stuff for kids.
- deleted 7y ago[deleted]
- StuffedParrot 7y agoThat seems pretty high for acetaminophen and low (proportionally) for ibuprofen. Why would you prescribe that?
- iudqnolq 7y ago500mg is the max for ace a doctor is recommended to proscribe (on it's own). 150 is well below the max for ibu. Also I think you may have mixed up the grandparent commentator that stated they were a doctor and the parent that may be a doctor but hasn't made that claim here.
- GoodOldNe 7y agoAm doctor. Routinely prescribe 1000 mg of Acetaminophen.
- wiggles_md 7y agoMight have to do with the claims are they seeking for Maxigesic?
- akiselev 7y agoClinical trials are complicated beasts. The simplest answer is likely that the CRO running the trials - at least I hope its a CRO - isn't set up to target the kind of patients/doctors needed for approval or they don't have funding immediately available to speed that process up at the necessary scale.
- refurb 7y agoWhat process is Maxigesic being approved under? I assume an aNDA, which is for generic drugs. The FDA has a massive backlog for generic drugs, while novel drugs (NDA) don’t.
- deleted 7y ago[deleted]
- refurb 7y agoAs someone who works in the drug industry, when Maxigesic is approved, please don't prescribe it. Just tell your patients to take one each of the OTC drugs, they are dirt cheap (like $0.02 per pill). The market is full of drugs that are combinations of OTC medications and usually they are way more expensive. Even if they didn't go nuts with the price, why make a patient pay $0.50 per pill when they could take 2 for $0.04?
- qrbLPHiKpiux 7y agoThat’s what I do now.
- refurb 7y agoGood stuff. Lots of doctors don’t. Not out of bad will, but they just don’t have the time to dig into it.
- ensignavenger 7y agoSome patients have a lot of pills to take, and they would rather pay more to take fewer. Maybe they have trouble keeping track of them, maybe it is just pill fatigue. Maybe they have trouble swallowing for one reason or another. Combo pills could be a good thing for a subset of the population. Sure, it requires doctors to be on top of their game and patients to research what they are taking and ask questions, but that doesn't mean it isn't a good idea to have it available as an alternative. As to the question about why it is taking so long at the FDA, I imagine it isn't a very high priority because there are alternatives.
- refurb 7y agoI don’t disagree that pill burden can be an issue. The problem is the lack of transparency into cost which results in some drug companies taking advantage. Combine two pills that cost $0.10 each into one pill that costs $0.15? Reasonable. Do the same and charge $5 per pill? Ridiculous. Problem is doctors and patients don’t know it costs $5 and insurers can’t be bothered to push back. Suddenly you’ve increased the cost of therapy by 50x.
- shsidns 7y agoIf I had to take a guess it’s because drug A + B != AB The drugs in question could, combined have deleterious effects (say if their extortion mechanisms are the same). This shouldn’t be a problem because Tylenol + Advil has been done for decades. However, a beauricracy doesn’t see it as a solved problem to fast track unless there is a specific fast track for this exact scenario.
- 1123581321 7y agoThis is a good thing. People die, and die sooner, when the FDA cannot adapt its approval process to drugs and tools for patients who sadly have little downside to trying them. In my own little corner (diabetes) it’s been nice to get monitoring tools earlier than they once would have been approved, and for my medical team to confidently plan for equipment changes based on future approvals.
- olliej 7y agoThe problem is the approval of drugs that don’t actually work, and so are actually harmful. the approval then means that companies can target people who are desperate with extremely expensive snake oil. The victims of this have no recourse if/when the drug has caused problems.
- cobbzilla 7y agoYou’re mixing two things: Doesn’t work = efficacy trials Is harmful = safety trials iirc the safety trials come first. A lot of drugs get stalled in efficacy trials because they might only work for some patients and the sample set is small or poorly chosen. I see no reason to stall drugs that are proven safe, even if they might not be effective for all patients, as long as there is full disclosure and informed consent. Freedom to choose is a good thing.
- lightedman 7y ago"You’re mixing two things:" Being ineffective can be very dangerous as a person taking a drug expecting it to alleviate their condition finds no relief and thus dies from their condition. You did not fully read and comprehend the parent post.
- cobbzilla 7y agoPost implied fairly plainly that “doesn’t work == harmful”, is there another way to read that?
- 7y ago
- ekianjo 7y ago> “It isn’t that we changed our policies and are saying we are going to approve drugs faster,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, who joined the agency under President Ronald Reagan. “The difference now is we are going to see more of those because of the science. If there are people out there with no options and they have terrible diseases, we are going to get those drugs to them as fast as feasible.” > But even as drugmakers, investors and patients cheer on the agency’s pace, patient-safety advocates argue that speed comes at a price. Studies show medicines approved on a faster time line are more likely to have safety problems emerge after they become broadly available, while other treatments offer fewer benefits than anticipated. Not sure I understand the concern: - "studies show medicines approved on a faster time line ...": which study(ies)? And that was the case for previous track records, which says nothing if the FDA is making the same mistakes that they may have done 20 years ago. - "more likely to have more safety concerns once they are broadly available while other treatments offer fewer benefits than anticipated", wait, do such studies actually have drugs that are virtually identical in all properties and where the only factor that changed is the approval timing? Because if that's not the case, you are just comparing drugs with different profiles, different indications, and different targets, which is pretty much apples and oranges. Good luck making conclusions based on that. I am not aware of the FDA or any other regulatory body at this time starting to remove regulatory requirements to speed up approvals. The typical things we see nowadays is an exception for "orphan indications" where there is no good treatment available and people are dying without anything to try. It seems fair that they take in account patients' needs when it comes to expediting the last bureaucratic mile to ensure new drugs can save more patients. At the end of the day, patients are also free to refuse newer drugs (and doctors usually tell them when a drug has just been approved and when there is lack of much safety experience beyond clinical trials) so I don't see how you can frame this whole story in a negative light.
- caseysoftware 7y agoI think this is the key section: _"It’s not just speed. The FDA also is approving more drugs, hitting a record 59 new therapies in 2018. Almost three-fourths received a priority review. That, combined with more efficient data collection, is responsible for the faster FDA action, said Aaron Kesselheim, a professor at Harvard Medical School. Companies are also communicating earlier and more often with the agency, which can head off issues at preliminary stages and help them get products through on the first attempt, he said."_ So as in any field, better communication with stakeholders improved the process and eliminated some issues earlier. Then, better data collection helps them evaluate studies better. I bet it also reduces the back and forth and the "what does this mean" aspect of the studies after. And then companies can pay for expedited evaluation.. which if they've been communicating clearly all along and have better data, doesn't seem far fetched. The next thing you know, someone will suggest clear planning with stakeholders, code reviews, and unit tests will improve code quality and even ship dates! But that may be crazy talk.
- gesman 7y agoEnough gazillion dollars can compress time and expand space.
- bitxbit 7y agoFDA is grossly understaffed. And more importantly, its policies are directly responsible for the skyrocketing prescription drug prices.
- dannyw 7y agoCould you give some examples? As far as I know, the policies of Congress are what is responsible for skyrocketing prescription drug prices.
- spsful 7y agoSame thinking here. I don't believe the FDA is forcing drug prices onto the public; it seems to be a system enabled by congress and abused by the public sector.
- mrfusion 7y agoHow about we raise an alarm when drugs aren’t approved promptly? People die when good drugs are held up in bureaucracy.
- domnomnom 7y agoWoah that's quite a claim. Care to expand?
- pitaj 7y agohttps://slate.com/culture/2013/11/dallas-buyers-club-true-story-fact-and-fiction-in-the-matthew-mcconaughey-movie-about-ron-woodroof.html https://slate.com/culture/2013/11/dallas-buyers-club-true-st...
- showyrfangs 7y agoThere are plenty of example of drugs costing 10-100x what they normally would, which pharma companies get all the heat for, are drugs that would otherwise have plenty of competition but dont due to to backlogs at the FDA. Including the most famous one: Epipens https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-drugs-vs-chairs/ https://slatestarcodex.com/2016/08/29/reverse-voxsplaining-d...
- rhexs 7y agoWhat party has some sort of vested interested (presumably monetary) in slowing down FDA drug approval? Perhaps I'm being a bit pessimistic here, but after reading the article I don't really see any motivation for the "raising alarm" statement in the title, or even a reason anyone would bother publishing this in the first place. I looked up the "consumer watchdog" that I'm guessing had something to do with this article, and their front page is just an "Impeach Trump" advertisement. See https://www.citizen.org/ https://www.citizen.org/. Also, if you click their "About Us" page, a few lines down is: "We don’t participate in partisan political activities or endorse any candidates for elected office." Hmm.
- burpsnard 7y agoWe've been hearing for years about accelerated drug candidate discovery through better tech and automation, and anecdotally a boom in clinical trials informatics etc, so not surprising
- Proven 7y agowhat alarm? the main and only problem is the FDA gets to decide. smaller problems: is they decide slowly and the socialist healthcare system makes it hard for people to avoid their poor judgement (when they do approve) or do something about their slowness (when you die before they do)