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Old 02-20-2012, 09:44 PM   #21
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Potentially missing the fact that drugs that are only marginally effective will lose market share = decreased sales = less profit when more effective drugs are available.

Data on trials used to support FDA approval are in the prescribing information, and something your doctor *should* know before prescribing. It's available to anyone but difficult for the average layperson to decipher. It's good to be an informed patient and do your research on a drug (via the internet) before speaking to (or challenging) your doc, but be prepared for pushback. Certainty, ask her why she's prescribing the new expensive wonder drug vs. the old cheap generic; docs are pretty used to that by now.

But a more cynical question might be, how do you and your doc learn of all the failed trials that the FDA didn't use for the approval? That's a subject of much debate now, and some recent efforts by the FDA to force drug co's to disclose all the pre-approval data, not just the favorable stuff.
+1 Wendy.
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Old 02-20-2012, 09:58 PM   #22
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I think the thing that bothers me most about the FDA approval process is the people/companies with the most to gain perform the research or the clinical trials, double blind study or not. We have a ways to go. I would not let my daughter get the Gardasil vaccine, told her why, etc. Didn't trust the push by the government and knew that things slip by the FDA..etc. Just the example that came to mind. Another is the breast implant industry. Wow....they should be taken totally off the market. Sorry guys!
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Old 02-20-2012, 10:22 PM   #23
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But a more cynical question might be, how do you and your doc learn of all the failed trials that the FDA didn't use for the approval? That's a subject of much debate now, and some recent efforts by the FDA to force drug co's to disclose all the pre-approval data, not just the favorable stuff.
Can you really trust your doc to give you unbiased information concerning drugs? The fact is that many doctors receive payments from drug companies making it even more difficult to trust any side in this battle. Of course we Americans also have ourselves to blame, always looking for the easy way out. Who wants to take responsibility for managing their own health when they can just pop a pill to fix their bad habits.
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Old 02-20-2012, 11:22 PM   #24
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+1 Wendy.
+2 Wendy
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Old 02-21-2012, 04:15 AM   #25
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The placebo effect isn't that people think they're getting better. They actually DO get better. Tumors disappear, baldness is reversed, ulcers go away... consider this Japanese study on poison ivy:

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Each was rubbed on one arm with a harmless leaf but were told it was poison ivy and touched on the other arm with poison ivy and told it was harmless. All 13 broke out in rash where the harmless leaf contacted their skin. Only two reacted to the poison leaves.
As you think so shall you be.

Given the power of placebos, a 14% improvement over placebos might actually mean you have a pretty good drug. To expect a >80% improvement over placebos in all cases might be asking too much.
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Old 02-21-2012, 07:20 AM   #26
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I think the thing that bothers me most about the FDA approval process is the people/companies with the most to gain perform the research or the clinical trials, double blind study or not. We have a ways to go.
Unfortunately, clinical trials are so expensive that only companies with an expectation of profit can afford to do them. In a nutshell, that's the basis for the patent system: rewarding "inventors" (including drug co's) for taking the financial risk to bring a new product to the marketplace.
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Old 02-21-2012, 07:33 AM   #27
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Can you really trust your doc to give you unbiased information concerning drugs? The fact is that many doctors receive payments from drug companies making it even more difficult to trust any side in this battle. Of course we Americans also have ourselves to blame, always looking for the easy way out. Who wants to take responsibility for managing their own health when they can just pop a pill to fix their bad habits.
Not blind trust, but ultimately you do need to trust that your doc has your best interests at heart, or find another doc. If you're not sure, ask your doc why she's prescribing a particular drug, and see if the answer makes sense. ("I like it" vs. "for a patient with your other conditions, this drug is safer, in my experience).

And while I don't have any hard data, I highly doubt that "many doctors" receive payment. The rules have changed over the years so that drug co sales reps can only give away small office items, like pens and books. Some docs, especially those who are leaders in their field, might consult with drug co's during the trial phase, and deliver presentations about the new drug at medical meetings. They are supposed to disclose all such affiliations. The days of docs taking money or its equivalent from co's in exchange for writing a drug are pretty much over. (At least I assume so, based on everything I know about the current system)

Most docs I know see sales reps, take the free samples for their patients, accept the pens and brochures, but still don't blindly prescribe the rep's drugs. Some don't see reps at all anymore.
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Old 02-21-2012, 08:00 AM   #28
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And while I don't have any hard data, I highly doubt that "many doctors" receive payment. The rules have changed over the years so that drug co sales reps can only give away small office items, like pens and books. Some docs, especially those who are leaders in their field, might consult with drug co's during the trial phase, and deliver presentations about the new drug at medical meetings. They are supposed to disclose all such affiliations. The days of docs taking money or its equivalent from co's in exchange for writing a drug are pretty much over. (At least I assume so, based on everything I know about the current system)

Most docs I know see sales reps, take the free samples for their patients, accept the pens and brochures, but still don't blindly prescribe the rep's drugs. Some don't see reps at all anymore.
Don't you think the companies are still attending the medical conferences, basically lobbying for their products (drugs, devices, etc.), throwing lavish affairs and providing "give aways"? Without naming "names", long ago we had one such company fund a Basic Skills Laboratory in our lab and who, at a conference, set up an ice skating rink with their logo in the middle...along with hosting extravagant "cocktails" etc. Nothing new....and done all the time.
Also, I do know a few who are spokesmen for drug companies..and yes, they are leaders in their fields. And yes they probably believe in the drug as these are ethical doctors.
I think as with everything it is "consumer" beware. I tend to believe all drugs have side affects. It is a matter of which is worse. The symptons/disease or the drug. Often, it is the less of two evils...that sort of thing.
It is the only system we have and I'd have to say it is probably more stringent than in other countries...but it is not perfect. Mistakes have been made and will continue to be made. Remember Vioxx? I have to think our doctors rely on the research and the FDA too , as they are too busy to dig into all the research don't you think? After all the FDA is the regulatory body.
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Old 02-21-2012, 08:42 AM   #29
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Don't you think the companies are still attending the medical conferences, basically lobbying for their products (drugs, devices, etc.), throwing lavish affairs and providing "give aways"?
Oh absolutely, this is a common practice. And your local doc may well attend "dinner meetings" to hear about the latest wonder drug. It's up to the doctor to sift through this information and consider it in light of clinical guidelines from medical organizations, articles in peer-reviewed journals and other professional sources.

A conservative approach taken by some docs is to wait to prescribe a new drug until it's been on the market a year or two rather than just rely on the clinical data approved by the FDA. BTW, you mentioned other countries-- the EU, at least, has a regulatory process similiar to the FDA's, with a comparable degree of rigor.

And yes, the system isn't perfect, and I don't see how it ever will be. All drugs have side effects. Some unsafe drugs will slip through the cracks, unfortunately. And some less-than-vigilant docs will prescribe inappropriate drugs, perhaps as a result of marketing pressure, or simply a lack of time to adequately research a new drug's profile.

Buyer beware.
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Old 02-21-2012, 08:47 AM   #30
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The placebo effect isn't that people think they're getting better. They actually DO get better. Tumors disappear, baldness is reversed, ulcers go away... consider this Japanese study on poison ivy:

As you think so shall you be.

Given the power of placebos, a 14% improvement over placebos might actually mean you have a pretty good drug. To expect a >80% improvement over placebos in all cases might be asking too much.

The piece did not say there was a 14% improvement OVER placebos, but a 14% improvment overall... which was the same percent improvement WITH a placebo.... so in other word, the drug in the pill did not do anything over no drug at all...


I would agree that if the drug actually produced a 14% improvement over the placebo this conversation would not be happening....
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Old 02-21-2012, 09:03 AM   #31
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Well, that's depressing.

..
My distrust of drug companies just keeps growing.
A good thing to distrust!

So far I managed to stay off any perscription drugs...

Over 100,000 people die each year from taking prescription drugs as prescribed ...
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Old 02-21-2012, 10:02 AM   #32
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Potentially missing the fact that drugs that are only marginally effective will lose market share = decreased sales = less profit when more effective drugs are available. Though that may not be readily apparent in that placebos do provide results in trials (same point as glippy below). The problem is the drug may not provide results any better than the placebo. If there was no placebo effect, we wouldn't be having this conversation?

But a more cynical question might be, how do you and your doc learn of all the failed trials that the FDA didn't use for the approval? That's a subject of much debate now, and some recent efforts by the FDA to force drug co's to disclose all the pre-approval data, not just the favorable stuff. That's what I was thinking we're entitled to, how many trials, how many failures, how many successes. And if they won't tell patients, you would think insurers would be all over this, denying or monitoring prescriptions with low probabilities of success. Naive maybe...
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The placebo effect isn't that people think they're getting better. They actually DO get better. Tumors disappear, baldness is reversed, ulcers go away...
+1. Earlier in this thread someone suggested doctors give patients placebos. But they'd have to charge for the actual drug to pull this off, so that won't reduce costs which is part of the question here. If our health care costs weren't so far out of line with other developed countries, I wouldn't be much worried about it. Not right to ask doctors to deliverately and routinely deceive patients anyway.
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Given the power of placebos, a 14% improvement over placebos might actually mean you have a pretty good drug. To expect a >80% improvement over placebos in all cases might be asking too much.
Arguably, but that's not how I read Dr Brown's statement, not on reread either (neither did Texas Proud). It's not a 14% improvement, the drug is only effective in 14% of cases, presumably ineffective/neglible for 86% of patients. Can we afford to spend health care money this way?

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The piece did not say there was a 14% improvement OVER placebos, but a 14% improvment overall... which was the same percent improvement WITH a placebo.... so in other word, the drug in the pill did not do anything over no drug at all...

I would agree that if the drug actually produced a 14% improvement over the placebo this conversation would not be happening....
+1
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Old 02-21-2012, 10:45 AM   #33
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This is a fascinating discussion of a controversy that's apparently rocking the medical community.

I dug up a NEJM article by Kirsch which rebuts many of the rebuttals he got from colleagues and pharma: Challenging Received Wisdom: Antidepressants and the Placebo Effect

As far as I can tell, he did a meta-analysis of clinical data, which is a different type of statistical analysis than the one used by the FDA to approve new drugs. The FDA only requires that two studies demonstrate a statistically significant improvement in the test drug vs. the placebo or some other comparator. The presence of other failed studies doesn't matter, if two meet this criteria. So a drug that represents a 14% improvement over placebo will be approved, as long as statistically that's a "significant difference" (ie, actual vs. random chance).

What I think Kirsch did was analyze a broader range of data, including unsuccessful, unpublished trials, submitted to the FDA. He quantitated the "placebo" effect and concluded that the drugs were only effective in a small subset of patients. Using his criteria, these drugs would not have been approved, or would have only been approved for certain patients with moderate or severe depression.

The problem is the drug may not provide results any better than the placebo. If there was no placebo effect, we wouldn't be having this conversation?

A drug showing no improvement over placebo wouldn't get approved. The problem here is that the studies used by the FDA for approval DID show an improvement, but Kirsch's analysis suggests that the FDA used a flawed methodology in analyzing the clinical data.

That's what I was thinking we're entitled to, how many trials, how many failures, how many successes. And if they won't tell patients, you would think insurers would be all over this, denying or monitoring prescriptions with low probabilities of success. Naive maybe...

I think virtually everyone agrees with you except the drug co's. The FDA is pushing co's to do just that, but I'm not sure how effective this effort is yet.

It's not a 14% improvement, the drug is only effective in 14% of cases, presumably ineffective/neglible for 86% of patients. Can we afford to spend health care money this way?

I can't locate an original source for the "14%". It could be either "14% improvement" or "14% of patients, who improved by x%", depending on how the trial was designed. Either way, I agree it's a very low number.
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Old 02-21-2012, 11:01 AM   #34
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This is a fascinating discussion of a controversy that's apparently rocking the medical community.

I dug up a NEJM article by Kirsch which rebuts many of the rebuttals he got from colleagues and pharma: Challenging Received Wisdom: Antidepressants and the Placebo Effect

As far as I can tell, he did a meta-analysis of clinical data, which is a different type of statistical analysis than the one used by the FDA to approve new drugs. The FDA only requires that two studies demonstrate a statistically significant improvement in the test drug vs. the placebo or some other comparator. The presence of other failed studies doesn't matter, if two meet this criteria. So a drug that represents a 14% improvement over placebo will be approved, as long as statistically that's a "significant difference" (ie, actual vs. random chance).

What I think Kirsch did was analyze a broader range of data, including unsuccessful, unpublished trials, submitted to the FDA. He quantitated the "placebo" effect and concluded that the drugs were only effective in a small subset of patients. Using his criteria, these drugs would not have been approved, or would have only been approved for certain patients with moderate or severe depression.

The problem is the drug may not provide results any better than the placebo. If there was no placebo effect, we wouldn't be having this conversation?

A drug showing no improvement over placebo wouldn't get approved. The problem here is that the studies used by the FDA for approval DID show an improvement, but Kirsch's analysis suggests that the FDA used a flawed methodology in analyzing the clinical data.

That's what I was thinking we're entitled to, how many trials, how many failures, how many successes. And if they won't tell patients, you would think insurers would be all over this, denying or monitoring prescriptions with low probabilities of success. Naive maybe...

I think virtually everyone agrees with you except the drug co's. The FDA is pushing co's to do just that, but I'm not sure how effective this effort is yet.

It's not a 14% improvement, the drug is only effective in 14% of cases, presumably ineffective/neglible for 86% of patients. Can we afford to spend health care money this way?

I can't locate an original source for the "14%". It could be either "14% improvement" or "14% of patients, who improved by x%", depending on how the trial was designed. Either way, I agree it's a very low number.
I think the 14% number was on the 60 minutes program... and I think it was 14% of patients now that I think about it...


Another thing to consider.... Kirsch did agree that the drugs were effective with major depression. It was the mild depression where the drug was shown to not do anything more than the placebo... It think you can do a study showing the drug works and get it approved... that does not mean it is effective for a subset of that population. Using the number given, it is 86% who gets no benefit... and going to a subset of mild depresses patients, the 14% who do get a benefit would presumably get the same benefit if they took a sugar pill....
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Old 02-21-2012, 11:07 AM   #35
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Another thing to consider.... Kirsch did agree that the drugs were effective with major depression. It was the mild depression where the drug was shown to not do anything more than the placebo... It think you can do a study showing the drug works and get it approved... that does not mean it is effective for a subset of that population. Using the number given, it is 86% who gets no benefit... and going to a subset of mild depresses patients, the 14% who do get a benefit would presumably get the same benefit if they took a sugar pill....
Then in an ideal world, the drugs would only be approved for patients with moderate to severe depression, and not mild. But I'm not sure if the original approval trials were designed to show this.

It's long been accepted that "talk therapy" is as effective as drug therapy for most patients with mild depression, although some show better improvment by combining the two. And that overall, SSRIs only help about 40% of patients, on average (that's the number I also heard, but Kirsch suggests it's much lower).

It appears that the UK's NICE, which functions as a sort of national formulary, came to the same conclusion. But here in the US, most insurance co's would prefer to pay for antidepressants than for talk therapy (just check your reimbursement rates). So that's another layer to consider.
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Old 02-21-2012, 11:18 AM   #36
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Another great post Wendy, clearly we're in your wheelhouse! Interesting and helpful.
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I can't locate an original source for the "14%". It could be either "14% improvement" or "14% of patients, who improved by x%", depending on how the trial was designed. Either way, I agree it's a very low number.
It did come from the 60 Minutes segment, Dr Michael Thase who was defending the status quo.
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Kirsch and his studies have triggered a furious counterattack – mainly from psychiatrists, who are lining up to defend the use of antidepressants like Dr. Michael Thase, a professor of psychiatry at the University of Pennsylvania School of Medicine, who has been a consultant to many of the drug companies.
Stahl: Irving Kirsch says that [anti]depressants are no better than placebo for the vast majority of people with depression, the vast majority. Do you agree with that?
Michael Thase: No, no. I don’t agree. I think you’re confusing, or he’s confusing, the results of studies versus what goes on in practice.
He says that Kirsch’s statistical analysis overlooks the benefits to individual patients.
And while he agrees there’s a substantial placebo effect …. Especially for the mildly depressed, using a different methodology, he finds that the drugs help 14 percent of those moderately depressed, and even more for those severely depressed.
Thase: Our own work indicates pretty convincingly that this is a large and meaningful effect for a subset of the patients in these studies.
Stahl: But even by your own numbers more people, maybe twice as many people, are having a placebo effect than are actually being helped by the drug.
Thase: That’s correct.
Stahl: In the moderate range?
Thase: That’s correct.
Stahl: And this isn’t troubling to you?
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Old 02-21-2012, 11:54 AM   #37
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Thanks, Midpack!

he finds that the drugs help 14 percent of those moderately depressed, and even more for those severely depressed.

And yet, that still doesn't tell us what % improvement those 14% had. Usually there is a threshold of efficacy established in the study design, such as "X % reduction in the ABC Depression Assessment score". This info should be in the prescribing information. (I'm sure it's in one of Kirsch's articles, I just didn't see it as I was skimming them.)

It gets back to points often made in this forum about drug or medical interventions. What does "the drug worked" mean? Some treatments may only improve outcome by, say, 5% compared to placebo. Even if that's enough for approval, is it worth the cost / risk to you personally? Hopefully your doctor is on top of these issues.
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Old 02-21-2012, 02:43 PM   #38
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Most people don't have time to research issues like this. Unfortunately, that may include your doctor.
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Old 02-21-2012, 04:56 PM   #39
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Most people don't have time to research issues like this. Unfortunately, that may include your doctor.
Unfortunately, I agree. But if anyone did want more info on prescribed drugs, a reasonable place to start is Drugs.com: Drugs.com | Prescription Drug Information, Interactions & Side Effects

For many common drugs, there are sections geared to varying levels of knowledge, from Patient to Advanced Patient to Professional. You can find the FDA-approved Prescribing Information (PI) and Patient Leaflets here, too. The data on clinical trials is in the PI.
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Old 02-21-2012, 09:44 PM   #40
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And while I don't have any hard data, I highly doubt that "many doctors" receive payment. The rules have changed over the years so that drug co sales reps can only give away small office items, like pens and books. Some docs, especially those who are leaders in their field, might consult with drug co's during the trial phase, and deliver presentations about the new drug at medical meetings. They are supposed to disclose all such affiliations. The days of docs taking money or its equivalent from co's in exchange for writing a drug are pretty much over. (At least I assume so, based on everything I know about the current system)
This site (Dollars for Docs - ProPublica) lists the known payments over the last couple years from the 12 drug companies that have started disclosing payments. There are still companies that do not publicly disclose payment information and these payments are not included in the total. At $760M it seems many are getting more then pens and books for payments. Paying someone as a 'consulting' is one of the common catch-all categories that a company can use justify any payment. The site also has a database that you can search to see if your doctor has received payments.
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