With market flooded with so many statin analogs, there was no sense of urgency to come out with a tandem pill. If ken frazier wants to be seen as a champion of innovation, he should put an end to that nonsense. As far as the fdas role in this, it is not in their purview to decide if a drug is needed or not.
Perhaps they feel that the additional risk of the combination is minimal or likely nothing. There really does seem to be something special about statins. Reduce flexibility in individualized dosing, for both components the best doses for the patient may not be achievable.
California press, berkeley, ca, 1974), reviewed the arguments against fixed-dose drug combinations. What merck is doing is applying for a new formulationcombination product. Singulair was a sugar pill for the most part.
I think that physicians are perfectly able to develop riskbenefit scenarios for their patients. In that case, however, the interpretation of safety would then have to incorporate efficacy if a drug provides little additional benefit compared to current drugs but does provide higher risks, it is effectively less safe. But for the record, many advocate exercise as a cure all for chd but it, like the merck drug combos, have not been yet shown to procvide benefit in a double blind placebo controlled study.
This has left some scratching their heads at fdas decision steve nissen, chairman of cardiology at the cleveland clinic, said, the approval just doesnt make any sense, i find it astonishing that after all the controversy about ezetimibe zetia, the fda would approve another combination product with a drug that been on the market for a decade and has not been shown to improve cardiovascular outcomes, nissen explained. Its unlikely fda would have approved a zetia combo if it was concerned about improve-its safety record, according to anderson fda is likely privy to the general findings from improve-its various interim looks that have occurred, and being a risk averse agency, if there were hints of harm it would likely steer clear of approved any new zetia formulations until full improve-it results are in. Virtually all of the preferred meds are me-toos, and the differences can be huge.
Is the guideline wrong? Perhaps, i dont know. While we know statins provide benefit in a proven double blind fashion, we do not know if it is simply due to lowering lipids or not correlation is not causation but that does not mean correlation without proof of causation is bunk, like with exercise, we rely on that type of evidence all the time. Physicians will be more apt to choose high doses of simvastatin, atorvastatin and crestorfor patients who can tolerate itsince those drugs have demonstrated that they improve health outcomes and prevent cardiovascular risks in trials. Ldl reduction of any product i dont know the extent (if any) to which this consideration contributed to mercks thinking, but simvastatin (and lovastatin) have distinguishing bad features among their sibling statins. In studies, it lowered cholesterol by 50making it the most effective ldl-lowering therapy available.
And honestly, do we really want the fda to decide what should be marketed? Frankly, the fda should get out of the efficacy business altogeter mds and payers are more than capable of determining whether a given compound is worth paying for, in fact it is being done already in health care systems and hospitals. Its not like merck tested this new combo against the old one, either, of course. But if you really do believe in the free market which your comments seem to defend they should be able to sell any new drug they want. And doctors obviously fell for it, since they wrote a bazillion scripts for the stuff. It doesnt make merck look so good, though, since it looks like theyre trying to chisel some more time out of an unoriginal idea.
The question is that in a very high lipid population who cannot control by a statin alone, what is the choice? They can wait for the data on out comes to come in or jumpstart the treatment based on the general cholesterol guidelines. I agree we dont know that advantages of this drug combo over anything else and that is up to the fda. I dont really see what the fdas job is or should be under your scenario if they cant assess efficacy, they cant do safety. With that, liptruzet appears destined to be a third string therapy. Also, the free market can be not-so-free if it is influenced by direct to consumer ads that push products that are no better than older alternatives.
Without a judgment of efficacy, safety cant be judged. The approval of a zetialipitor combo does dial back concerns that the improve-it trial could show that vytorin, or its zetia component, is potentially harmful. With regard to the fda, yes- they are not responsible for determining whether a drug is innovative, or has any real advantage over other drugs. To be an fda medical officer, one must hold a current us medical license. Silverman and lee, in their classic text pills, profits, and politics (univ. If ken frazier wants to be seen as a champion of innovation, he should put an end to that nonsense. You can hardly say that singulair (montelukast) is a sugar pill. Singulair is a classic case of merck ripping off the public. Their metabolism is entirely cyp3a4-dependent, so serum levels in the presence of cyp3a4 inhibition can be 20-fold increased thats where most of the aes seem to come from. But, the devils advocate in me is wondering if this is inconsistent with your opinions on me too drugs derek.of-pocket, and you opt for a generic instead of a brand name statin. ... products generated $16.9 billion in u.S. sales in 2012. One statin .... generic) and atorvastatin (lipitor and generic). ... liptruzet or vytorin works better than the statin alone.