{"items": [{"author": "Joshua", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226492914064097", "anchor": "fb-226492914064097", "service": "fb", "text": "New drugs are almost always more expensive, not less expensive than older (often generic) drugs. If a drug company produces a new drug that's less effective and more expensive than an older drug, they will advertise it and push it to doctor's. Patients will end up with the less effective, more expensive drug. This will raise costs for everyone. There is possibly a legitimate case that FDA approval takes too long, but is it really because of the efficacy requirement? Our health care system is distorted in many ways. Often what seems like a very reasonable proposal will have a negative impact.", "timestamp": "1313510813"}, {"author": "Jeff Kaufman", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226497790730276", "anchor": "fb-226497790730276", "service": "fb", "text": "@Joshua: one solution: you currently can't advertise drugs for off label uses. If we remove the efficacy requirement, there's no on-label/off-label distinction. So modify the advertising rule to say you can't advertise drugs unless they've been proven effective for the advertised use.
Even without this, though, I'm not sure this is a real problem. The cost of new drugs would probably go down without efficacy testing because it would take less time to approve drugs [1].
[1] time is highly related to the efficacy requirement: phase I trials (safety) are pretty short and stage II and II trials (efficacy) are most of the trial time.", "timestamp": "1313511587"}, {"author": "Joshua", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226499637396758", "anchor": "fb-226499637396758", "service": "fb", "text": "The price of drugs is determined by what the drug companies think they can get. If a drug is new and patented, they have a monopoly on it. Oh wait, I forgot that drug companies are our pals. If they save money on the FDA process, then they'll surely pass the savings on to us. How will anyone know whether to prescribe a new drug if it hasn't gone through efficacy trials? They are expensive and time consuming, but you need these studies to determine what is the most effective treatment.", "timestamp": "1313511886"}, {"author": "Joshua", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226500290730026", "anchor": "fb-226500290730026", "service": "fb", "text": "Safety of drugs is only meaningful relative to potential benefit. Sure some drugs are dangerous and shouldn't be used under any circumstances, but most have some safety issues, but are worth taking the small risk because there is a significant benefit.", "timestamp": "1313511997"}, {"author": "Jeff Kaufman", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226506210729434", "anchor": "fb-226506210729434", "service": "fb", "text": "@Joshua:
\"The price of drugs is determined by what the drug companies think they can get. If a drug is new and patented, they have a monopoly on it. Oh wait, I forgot that drug companies are our pals. If they save money on the FDA process, then they'll surely pass the savings on to us.\"
I agree that in cases where a drug company comes up with a new drug for which there are no competing treatments, they will charge as much as they can and lowering the cost of bringing drugs to market shouldn't be expected to reduce the final price. I don't think this is most of the time, though. Most of the time there are options, and while people pay attention to price for medicine much less than for other things, prices are controlled somewhat by competition. Making it easier for more companies to create new drugs should increase competition and bring down prices.
\"How will anyone know whether to prescribe a new drug if it hasn't gone through efficacy trials? They are expensive and time consuming, but you need these studies to determine what is the most effective treatment.\"
People will determine whether prescribe them the same way they currently do with off label uses. For example, sometimes a drug is similar to another drug, and so people will start using it in cases where the first drug is effective. As people collect more data on how well it worked in those cases they let other people know. This is a working system (working at least as well as the introduction of new on-label uses).
\"Safety of drugs is only meaningful relative to potential benefit. Sure some drugs are dangerous and shouldn't be used under any circumstances, but most have some safety issues, but are worth taking the small risk because there is a significant benefit.\"
The fda doesn't deal with this very well currently. I don't see how this makes it worse.", "timestamp": "1313513001"}, {"author": "Phillip", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226516154061773", "anchor": "fb-226516154061773", "service": "fb", "text": "You can imagine making approval two steps. Safety makes it available, but restricts distribution and advertizing, and efficacy takes all of the restrictions off. I don't know how drug companies price, but I expect that the product manager has to show market size, and price it to at the least cover all development costs, manufacturiung and distribution costs, it's share of failed development costs of other drugs (or the company quickly goes out of business), the cost of capital invested, and risk adjusted profit. If the price can't do this, the drug doesn't get developed.", "timestamp": "1313514550"}, {"author": "Joshua", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226518550728200", "anchor": "fb-226518550728200", "service": "fb", "text": "@Jeff \"For example, sometimes a drug is similar to another drug, and so people will start using it in cases where the first drug is effective. As people collect more data on how well it worked in those cases they let other people know.\" Bad idea. If you don't do a statistically meaningful study (preferably double blind), you have no clue how effective a drug is. Anecdotal evidence is extremely unreliable. If you can find 20 people who have had an amazing cure from a drug, it is absolutely meaningless unless you know how many other people took the drug and did not get cured. Drug companies have lots of money and lots of influence. Even if they can't advertise, they can easily find doctors who will advocate for them (oh the doctor just happens to consult for the company).", "timestamp": "1313514907"}, {"author": "Erin", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226538554059533", "anchor": "fb-226538554059533", "service": "fb", "text": "Jeff, if this is something that interests you (\"something\" being the FDA and its rules for drug approval) you should look at this situation: http://healthcareorganizationalethics.blogspot.com/...", "timestamp": "1313517819"}, {"author": "Erin", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226539070726148", "anchor": "fb-226539070726148", "service": "fb", "text": "Ooops, meant to add that it's not directly related to the situation you're discussing but may be of interest.", "timestamp": "1313517901"}, {"author": "Mac", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226563990723656", "anchor": "fb-226563990723656", "service": "fb", "text": "America leads the world in medical $ spent per capita. And we are WAY back in the pack of developed countries for health, effectiveness, outcomes. To stem the flood of arguments, two truths: 1) We have the \"best\" medicine in terms of research, advanced science and technology, and 2) for a first world country, one of the worst average care delivered. Reread these. Both sides can wordsmith these statements to proclaim redfaced with passion that we are the best and the worst. That being said, the FDA is between a rock and a hard place, where their inadequately funded system delays \"good\" drugs, and lets \"bad\" drugs slip through. What does Europe do?", "timestamp": "1313521411"}, {"author": "Jeff Kaufman", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226569670723088", "anchor": "fb-226569670723088", "service": "fb", "text": "@erin: reading that article, it looks like the real problem was that colchicine was already known to be effective and didn't need a study. So the incentives set up by the fda which amounted to a trade of a temporary monopoly in exchange for a study didn't make sense.", "timestamp": "1313522207"}, {"author": "Jeff Kaufman", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226576757389046", "anchor": "fb-226576757389046", "service": "fb", "text": "@Joshua: before colcrys went through trials, I'm not sure there had ever been a statistically meaningful study on colchicine. People had been using it for a long time, it was generic so no one stood to profit by a study. Would you really say we had \"no clue how effective\" it was? And that formal fda approval of it was needed?
It also sounds like you are opposed to off label use in general. Amoxicillin is now a generic, and is currently commonly used off-label to treat stomach ulcers. I don't believe there's ever been a study on its effectiveness for this purpose. Should doctors stop prescribing it for stomach ulcers?", "timestamp": "1313523133"}, {"author": "Joshua", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226597390720316", "anchor": "fb-226597390720316", "service": "fb", "text": "I think it was good to do a study on colcrys and really bad to give the drug company a monopoly on it. We need more studies that are funded by government grants not by the drug companies. I am not opposed to off label use, but think that there should be studies to confirm that it is effective. We need to be much more efficient in our medical system. That means we need to be using the most cost-effective treatment. Yes that means that if there is an inexpensive treatment and a $50,000 treatment, we should use the inexpensive treatment even if the very expensive one is slightly more effective. This is a difficult ethical issue, but one that we have no choice but to make. Spending a lot of money on one thing means that there is less money available for other health care. And the really important question I have is \"how do I get blank lines in my responses without breaking them into separate responses?\"", "timestamp": "1313525834"}, {"author": "Jeff Kaufman", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226600817386640", "anchor": "fb-226600817386640", "service": "fb", "text": "\"how do I get blank lines in my responses without breaking them into separate responses\" -- press shift+enter", "timestamp": "1313526246"}, {"author": "Joshua", "source_link": "https://www.facebook.com/jefftk/posts/226475757399146?comment_id=226606667386055", "anchor": "fb-226606667386055", "service": "fb", "text": "thanks
a bunch.", "timestamp": "1313526939"}, {"author": "David Chudzicki", "source_link": "https://plus.google.com/106120852580068301475", "anchor": "gp-1313605948712", "service": "gp", "text": "It makes sense to expect drug choices to be somewhat price sensitive, but a serious problem is that incentives are set up so that no one in the decision really cares much about the price. ", "timestamp": 1313605948}, {"author": "David Chudzicki", "source_link": "https://plus.google.com/106120852580068301475", "anchor": "gp-1313605983608", "service": "gp", "text": "Meant to say also: it's a hard problem. I don't know the solution. ", "timestamp": 1313605983}, {"author": "Jeff Kaufman", "source_link": "https://plus.google.com/103013777355236494008", "anchor": "gp-1313607328910", "service": "gp", "text": "The logical people to make decisions about price would be insurance companies.", "timestamp": 1313607328}]}