Novartis' new miracle drug

gravenewworld

http://abcnews.go.com/Health/Healthd...4561968&page=1



This looks like it is going to be the next huge multibillion dollar blockbuster drug. The results sound amazing. From what I gathered from other news sources at work, they had to suspend clinical trials because it would have been unethical to keep the patients on placebo since the results of the combo drug were so amazing.

Moonbear

I'm never comfortable with that approach. It's sort of like saying, "We got the result we wanted so are going to stop the experiment before we find out it doesn't hold up over time." The other reason I don't like it is it indicates the trial has NOT remained double blinded, but someone cracked the code and peeked at the results before finishing it.

There's no reason patients should have been on placebo either...they should have been on whatever the best FDA-approved drug currently is, and results should be compared to that, not placebo.

Briant232

These drugs have been around for a long time. You'd probably save yourself a bunch of money buying the two drugs seperately. At least that's how it usually seems to work.

gravenewworld

Just because you have two drugs that have been around doesn't mean that you can combine them automatically to get the same effects that are seen with this new drug. Formulation can play a HUGE role in the efficacy in a drug. Many times drug companies take old generic medicines, reformulate them to improve activity, and are able to patent it because it is an entirely new formulation.

Briant232

Check this out:

http://www.medscape.com/viewarticle/558907

Notice how they refrained from doing the obvious comparison.

gravenewworld

Login screen?

Briant232

I guess you have to be registered to see that page. See if this works:

http://bcbsma.medscape.com/viewarticle/558907

Moonbear

Is that the only way to access that article? I get a login screen as well. What's the citation for the article, in case it doesn't require using that service to access it (as far as I can tell, that's not an actual journal or publisher site, but a service that provides access to articles).

Briant232

Look at what they compared Exforge® with and what they didn't compare it with in their studies:

http://www.fda.gov/cder/foi/label/2007/021990lbl.pdf

Moonbear

What did they NOT compare it with that you think they should have. You're being awfully cryptic, and I don't really know why. After searching through several pages of that 27 page document, I came across information that it was compared to either drug alone in each of the doses used in the combination dose-response study and placebo. What else would you like it compared to?

Briant232

Both drugs given together, but as separate pills.

The main point is that they find ways to repatent exhisting technology. It may aid in compliance to combine the drugs into one pill, but at what price to the patient and system? But is the combination pill better per se that the two drugs taken at about the same time?

Moonbear

No reason to give it as separate pills vs one pill in a clinical trial unless the pill needs to contain different inactive ingredients when combined (but that's what the placebo control is for). The rules concerning patenting are different than the rules for FDA approval; clinical trials are to get FDA approval for the combination treatment...without it, any prescribing of the two together would be considered off-label use and would raise the liability of the physicians if they were to use it. They aren't making any claims that it would be better to take it in one pill vs two separate pills that I know of. If it helps them retain their patent rights, good for them, but better for the patient if they test the combination properly before it is prescribe that way. We don't need to see another incident like the Phen-Fen disaster because a company encourages off-label prescribing of drug combinations without testing it first.

Briant232

Why should medicare or medicaid or my insurance company or me or anyone else pay for a drug that does no better than currently available drugs?

"Just because you have two drugs that have been around doesn't mean that you can combine them automatically to get the same effects that are seen with this new drug. Formulation can play a HUGE role in the efficacy in a drug. Many times drug companies take old generic medicines, reformulate them to improve activity, and are able to patent it because it is an entirely new formulation." --gravennewworld

That is why I linked this. People are marketing drug combinations to physicians and others as though they are better. Maybe no one really bothers to see if they are better, but they should, since the drug companies are trying to transfer as much money to themselves as possible. They could have tested the drugs separately, but then they couldn't charge as much. They do this all the time and market the drugs all over. They can do this and I can say, yeah, but...

meister

The only real reason I can think of is compliance, which is a huge factor to consider. It's the same reason why a physician would prescribe Levaquin 500mg QD vs. Keflex 500mg QID.

I know my grandmother complains about taking so many pills. Does that mean her medicare should pay an extra $100 just to appease her laziness? I don't know, but I do know that if she were to stop taking her blood pressure medication as the result of such things it could result in a very expensive hospital stay.

Briant232

Compliance is also the only reason I can think of. Some people say there are better formulations (extended release, fewer side effects, etc.) If someone can prove a combination drug is better in some way, fine. But I have the same question you have: How much is it worth? If you could take someone who needs 30 drugs down to five pills a day with improved formulations, that may be worth a premium, but it looks like more often than not, the increased price is not justified.

Moonbear

That depends...do you want the pharmaceutical companies to stay open to produce the drugs, and do you want them to keep their R&D departments open to develop new drugs for conditions don't have any good drugs to treat them yet? If you answered yes to either or both of those questions, then the price is justified. If they lose all their profits as soon as a drug's patent runs out and generic manufacturers can take over production, and you curtail their ability to find another way to make a profit, then they're going to close up shop and you'll have nothing.

On the other hand, in the longer term, paying for a single pill is cheaper than paying for two pills, since with two pills you pay the copay for EACH pill, not just one copay for the combined pills. That makes a big difference to the.

meister

I was mostly considering situations where the two separate medications each have a generic and the combination doesn't. In that case, the two separate medications would probably be cheaper both to the patient and to the insurance company than if the patient were to get a combination medication.