Someone has to take the blame... don't they?
On a forum I frequent, a post was put up today regarding this study, in which a link was found to exist between use of Celebrex and major heart problems. And, of course, the blamethrowing began. Is it FDA's fault? Is it the fault of the pharmas? Is it doctors' fault for overprescribing? Whose fault is it? Everyone knows it has to come back to one entity... doesn't it?
Sorry, folks, but I don't think it does. A lot of it is left to chance. FDA approves drugs based on the data that's presented, and the amount of data presented has to fulfill certain criteria that are clearly delineated in regulations and guidance regarding those regulations. At some point, though, you need to stop evaluating and place the drug up for approval, or you're (a) never going to have a chance to help people, and, frankly, (b) never going to make money. So clearly that's one point of risk: you can never have full disclosure because you can't evaluate a drug forever before releasing it on the market.
Another point of risk is pharmaceutical direct-to-consumer advertising. Celebrex and the other coxibs didn't actually show any greater effect against arthritis pain than traditional NSAIDs such as ibuprofen and naproxen. COX-2 inhibitors were developed for a specific reason: to allow people with risk of GI bleeding to take anti-inflammatory medications for arthritis. (NSAIDs inhibit both COX-1 and COX-2, and inhibition of COX-1 is linked with greater risk of GI bleeding.) However, none of that was anywhere near the DTC advertising. All consumers saw was that there was a new, whiz-bang drug for arthritis; as we all know, new is always better, so people would trot off to their doctors asking for prescriptions. Doctors had no evidence of severe risk in prescribing the coxibs, so prescribed they were, in vast amounts. On one hand, that's helpful, as it helps us learn about the drug; on the other hand, the risks of the drug are a hard lesson for 27,000+ people to learn.
A third point of risk is insurance; a lot of people have prescription drug coverage, and that leads to a lot of people wanting prescription drugs rather than OTC drugs, which they'd have to pay for themselves. If Joe Smith has a plan that allows him to get three months of a formulary drug (or even a non-formulary drug) for one co-pay of $20 or $30, depending on how many doses he needs versus how many the doctor wrote the scrip for, Joe could be in much better financial shape with that than trying to buy three months or more of ibuprofen or naproxen, provided he goes with a brand name. On top of that, he gets the new, whiz-bang drug for less than the old, boring one; quite appealing, wouldn't you say?
Something that many people have trouble with is that there is no safe drug. Derek Lowe covered this topic quite well in one of his In The Pipeline articles, so I won't rehash the topic here, but I do suggest everyone go and read; it's worthwhile. It's a topic that causes a lot of people discomfort, and when they see problems like the coxibs are having crop up, they're desperate to blame someone because they feel the system should be foolproof. It's not. It is, I believe, a fundamentally good system, largely staffed by people who are interested in and focused on doing well and improving the human condition, but foolproof and perfect it's not.
Sorry, folks, but I don't think it does. A lot of it is left to chance. FDA approves drugs based on the data that's presented, and the amount of data presented has to fulfill certain criteria that are clearly delineated in regulations and guidance regarding those regulations. At some point, though, you need to stop evaluating and place the drug up for approval, or you're (a) never going to have a chance to help people, and, frankly, (b) never going to make money. So clearly that's one point of risk: you can never have full disclosure because you can't evaluate a drug forever before releasing it on the market.
Another point of risk is pharmaceutical direct-to-consumer advertising. Celebrex and the other coxibs didn't actually show any greater effect against arthritis pain than traditional NSAIDs such as ibuprofen and naproxen. COX-2 inhibitors were developed for a specific reason: to allow people with risk of GI bleeding to take anti-inflammatory medications for arthritis. (NSAIDs inhibit both COX-1 and COX-2, and inhibition of COX-1 is linked with greater risk of GI bleeding.) However, none of that was anywhere near the DTC advertising. All consumers saw was that there was a new, whiz-bang drug for arthritis; as we all know, new is always better, so people would trot off to their doctors asking for prescriptions. Doctors had no evidence of severe risk in prescribing the coxibs, so prescribed they were, in vast amounts. On one hand, that's helpful, as it helps us learn about the drug; on the other hand, the risks of the drug are a hard lesson for 27,000+ people to learn.
A third point of risk is insurance; a lot of people have prescription drug coverage, and that leads to a lot of people wanting prescription drugs rather than OTC drugs, which they'd have to pay for themselves. If Joe Smith has a plan that allows him to get three months of a formulary drug (or even a non-formulary drug) for one co-pay of $20 or $30, depending on how many doses he needs versus how many the doctor wrote the scrip for, Joe could be in much better financial shape with that than trying to buy three months or more of ibuprofen or naproxen, provided he goes with a brand name. On top of that, he gets the new, whiz-bang drug for less than the old, boring one; quite appealing, wouldn't you say?
Something that many people have trouble with is that there is no safe drug. Derek Lowe covered this topic quite well in one of his In The Pipeline articles, so I won't rehash the topic here, but I do suggest everyone go and read; it's worthwhile. It's a topic that causes a lot of people discomfort, and when they see problems like the coxibs are having crop up, they're desperate to blame someone because they feel the system should be foolproof. It's not. It is, I believe, a fundamentally good system, largely staffed by people who are interested in and focused on doing well and improving the human condition, but foolproof and perfect it's not.
posted by m at 1:19 PM
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