Comments on: How A Big Clinical Trial Made Little Difference http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/ News, Comment and Conversation Fri, 10 Feb 2012 21:03:30 +0000 http://wordpress.org/?v=2.6.2 By: Pharma observer http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383423 Pharma observer Tue, 02 Dec 2008 02:22:03 +0000 http://www.pharmalot.com/?p=18082#comment-383423 I too was working on a hypertension launch when ALLHAT was in the field, similar to Generics is Union. Let me clarify what I think GIU is saying (and that I learned when working in this field) Hypertension is a silent disease, that people don't know they have until they go to the doctor. I have heard patients talk about that as long as they stay away from "the pressure" (stressful situations) they believe they don't need medication. A big group of people never pick up their second prescription and another group stop taking their medication before 12 months are up. But meanwhile, their hypertension is still as bad as ever, but they don't know it. If you add potential side effects - impotence from Beta Blockers and having to go the bathroom all the time (diuretics) - then patients are even more likely to stop taking medication that they don't believe they need and don't want to pay for/think they can't afford to pay for. Doctors know this and they try to avoid giving medication that patients won't tolerate well. And now that ACE Inhibitors generics are available, they don't have to make that trade off - except if their patient is an ACE I cougher (20% approx) .....then they are stuck with the ARBs - the cleanest drug class for treating High Blood Pressure. So, yes, medicine has moved on. I also do agree that promoting the results would have had a bigger effect. The state of Pennsylvania is experimenting with counter detailing with a program designed by Jerry Avorn - I wonder what their result have been in hypertensio. I do see one article that says they have saved over half a billion dollars in Nexium prescriptions. http://bulletin.aarp.org/yourhealth/medications/articles/drug_rep_ties_that_bind_1.html I too was working on a hypertension launch when ALLHAT was in the field, similar to Generics is Union. Let me clarify what I think GIU is saying (and that I learned when working in this field)

Hypertension is a silent disease, that people don’t know they have until they go to the doctor. I have heard patients talk about that as long as they stay away from “the pressure” (stressful situations) they believe they don’t need medication. A big group of people never pick up their second prescription and another group stop taking their medication before 12 months are up. But meanwhile, their hypertension is still as bad as ever, but they don’t know it. If you add potential side effects - impotence from Beta Blockers and having to go the bathroom all the time (diuretics) - then patients are even more likely to stop taking medication that they don’t believe they need and don’t want to pay for/think they can’t afford to pay for.

Doctors know this and they try to avoid giving medication that patients won’t tolerate well. And now that ACE Inhibitors generics are available, they don’t have to make that trade off - except if their patient is an ACE I cougher (20% approx) …..then they are stuck with the ARBs - the cleanest drug class for treating High Blood Pressure.

So, yes, medicine has moved on. I also do agree that promoting the results would have had a bigger effect. The state of Pennsylvania is experimenting with counter detailing with a program designed by Jerry Avorn - I wonder what their result have been in hypertensio. I do see one article that says they have saved over half a billion dollars in Nexium prescriptions.

http://bulletin.aarp.org/yourhealth/medications/articles/drug_rep_ties_that_bind_1.html

]]> By: Just A Thought http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383422 Just A Thought Tue, 02 Dec 2008 02:15:32 +0000 http://www.pharmalot.com/?p=18082#comment-383422 Pharma Newbie, It is apples and apples. You can eat a couple of big pricey apples or 4 smaller ones bought at a discount in a 5 pound bag. Ounce for ounce the nutritional value is the same. Dosing combination = 6 times a day? That's a reach. If low dose aspirin can be taken in conjunction with dipyridamole (thus Aggrenox) are you dosing the aspirin separately? Come on. The huge cost is not justified for that small level of convenience. Pharma Newbie,

It is apples and apples. You can eat a couple of big pricey apples or 4 smaller ones bought at a discount in a 5 pound bag. Ounce for ounce the nutritional value is the same.
Dosing combination = 6 times a day? That’s a reach. If low dose aspirin can be taken in conjunction with dipyridamole (thus Aggrenox) are you dosing the aspirin separately? Come on. The huge cost is not justified for that small level of convenience.

]]> By: Pharma Newbie http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383354 Pharma Newbie Mon, 01 Dec 2008 01:20:03 +0000 http://www.pharmalot.com/?p=18082#comment-383354 Just a thought-- the dosing combination for the aspirin and the dipryidamole was 6 times a day for the same efficacy. Hence the reason for Aggrenox effectiveness is the extend release component. Not an apples to apples comparison, secondly most physicians worth a salt due prescribe a Diuretic first then an ACE and lastly an Arb. Just a thought– the dosing combination for the aspirin and the dipryidamole was 6 times a day for the same efficacy. Hence the reason for Aggrenox effectiveness is the extend release component. Not an apples to apples comparison, secondly most physicians worth a salt due prescribe a Diuretic first then an ACE and lastly an Arb.

]]> By: Just A Thought http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383345 Just A Thought Sun, 30 Nov 2008 21:56:23 +0000 http://www.pharmalot.com/?p=18082#comment-383345 Reading this article instantly brought Aggrenox to mind. A couple of compounds combined into a very pricey pill. Someone convinced doctors that it was worthy of replacing aspirin and dipyridamole (which I believe was available in generic form at the time). It's creation was not exactly the height of R&D. The industry shouldn't be taking effective products and making them more costly than they have to be, calling them cutting edge, and pricing them high as if they are something new. Maybe a diuretic is sufficient for one man- but in prescribing a combo-drug, how can a doctor know? All he can know for sure is that the risks are increased by the addition of another compound. Still, it looks good on paper. Doctors are getting the hard sell. The FDA approves them. How much research should the family doctor be required to do between patients? Am I misinformed? Reading this article instantly brought Aggrenox to mind. A couple of compounds combined into a very pricey pill. Someone convinced doctors that it was worthy of replacing aspirin and dipyridamole (which I believe was available in generic form at the time). It’s creation was not exactly the height of R&D.
The industry shouldn’t be taking effective products and making them more costly than they have to be, calling them cutting edge, and pricing them high as if they are something new.
Maybe a diuretic is sufficient for one man- but in prescribing a combo-drug, how can a doctor know? All he can know for sure is that the risks are increased by the addition of another compound.
Still, it looks good on paper. Doctors are getting the hard sell. The FDA approves them. How much research should the family doctor be required to do between patients?

Am I misinformed?

]]> By: Justice in MI http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383316 Justice in MI Sun, 30 Nov 2008 06:28:26 +0000 http://www.pharmalot.com/?p=18082#comment-383316 Ol Cranky and Doc - Good to "see" you here again; I think it's been a while (at least for Ol Cranky). What has struck me about the original article (definitely recommended) is a kind of disconnect between its themes and its substance. The Cardura and Norvasc sagas, the relative suppression of increased relative risk of heart failure and stroke with these newer drugs, is generally overwritten by a narrative of mulitple factors and "life and medicine are complex." But if you read the article for facts, and ignore the narrative superimposed upon them, I don't think that's where you come out. Ol Cranky and Doc - Good to “see” you here again; I think it’s been a while (at least for Ol Cranky).

What has struck me about the original article (definitely recommended) is a kind of disconnect between its themes and its substance. The Cardura and Norvasc sagas, the relative suppression of increased relative risk of heart failure and stroke with these newer drugs, is generally overwritten by a narrative of mulitple factors and “life and medicine are complex.” But if you read the article for facts, and ignore the narrative superimposed upon them, I don’t think that’s where you come out.

]]> By: Doc http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383305 Doc Sun, 30 Nov 2008 04:07:59 +0000 http://www.pharmalot.com/?p=18082#comment-383305 Ol Cranky, ALLHAT was a solid study, at release many docs were impressed and started to re-prescribe those standbys, which were dirt cheap. But with no regular push, the BBs and diuretics were doomed. It wasn't side effects that killed these drugs, it was thousands of well spoken, well dressed, honorarium toting, meal providing, marketing financed, pharma sales reps using the "Emporer's new clothes" approach. If you couldn't see the multitude of benefits from ACEIs, CCBs, ARBs - then you were not fit for your job. Generics can't really compete in that environment, and it's costing us taxpayers mucho dinero. Ol Cranky,
ALLHAT was a solid study, at release many docs were impressed and started to re-prescribe those standbys, which were dirt cheap. But with no regular push, the BBs and diuretics were doomed.

It wasn’t side effects that killed these drugs, it was thousands of well spoken, well dressed, honorarium toting, meal providing, marketing financed, pharma sales reps using the “Emporer’s new clothes” approach. If you couldn’t see the multitude of benefits from ACEIs, CCBs, ARBs - then you were not fit for your job.

Generics can’t really compete in that environment, and it’s costing us taxpayers mucho dinero.

]]> By: ol cranky http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383291 ol cranky Sat, 29 Nov 2008 18:27:48 +0000 http://www.pharmalot.com/?p=18082#comment-383291 In truth, I think a lot of GPs routinely prescribe newer, more expensive, drugs so they feel like they're on the cutting edge and treating their patients in the 'most up to date" fashion. A lot of this comes from within the docs themselves and not from being detailed by sales reps - the docs, like the average consumer, just automatically think new = better regardless of the truth of the matter. While the pharma companies do their share of bad, too many docs are just plain lazy. In truth, I think a lot of GPs routinely prescribe newer, more expensive, drugs so they feel like they’re on the cutting edge and treating their patients in the ‘most up to date” fashion. A lot of this comes from within the docs themselves and not from being detailed by sales reps - the docs, like the average consumer, just automatically think new = better regardless of the truth of the matter. While the pharma companies do their share of bad, too many docs are just plain lazy.

]]> By: Meg http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383241 Meg Fri, 28 Nov 2008 20:38:05 +0000 http://www.pharmalot.com/?p=18082#comment-383241 Dr. Fuhrburg - one of my heroes from an FDA Hearing on placing black box warnings on all the dangerous ADHD drugs. He and Dr. Nissen got their committee to vote yes, much to the shock of the FDA. FDA and Pharma were "saved" however when the Pediatric Advisory Committee voted no, no black box warnings. Every now and then a reputable doc sticks his/her neck out on one of advisory committees, even if nothing happens in the end. Dr. Fuhrburg - one of my heroes from an FDA Hearing on placing black box warnings on all the dangerous ADHD drugs. He and Dr. Nissen got their committee to vote yes, much to the shock of the FDA. FDA and Pharma were “saved” however when the Pediatric Advisory Committee voted no, no black box warnings.

Every now and then a reputable doc sticks his/her neck out on one of advisory committees, even if nothing happens in the end.

]]> By: Justice in MI http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383240 Justice in MI Fri, 28 Nov 2008 20:24:17 +0000 http://www.pharmalot.com/?p=18082#comment-383240 Generics - I don't follow this part of your post: "The feedback from doc’s was v telling: I can’t Rx BB & diuretics because of side effects. ACE’s & CCB’s are well-tolerated. This is thee silent killer. Compliance is 1st priority." What are/is the "silent killer"? Whose compliance is at issue, docs or pts? Generics - I don’t follow this part of your post:

“The feedback from doc’s was v telling: I can’t Rx BB & diuretics because of side effects. ACE’s & CCB’s are well-tolerated. This is thee silent killer. Compliance is 1st priority.”

What are/is the “silent killer”? Whose compliance is at issue, docs or pts?

]]> By: Generics are unions http://www.pharmalot.com/2008/11/how-a-big-clinical-trial-made-little-difference/#comment-383231 Generics are unions Fri, 28 Nov 2008 19:01:59 +0000 http://www.pharmalot.com/?p=18082#comment-383231 In 1995 the JNC V was published, documenting why BBs and diuretics should be first line. I participated in the launch of Ziac, combining the best-selling BB in EU and 6.25mg of HCl. Highest dose has placebo-level side effects with 80% efficacy. Drug didn't hit $100m in sales. The feedback from doc's was v telling: I can't Rx BB & diuretics because of side effects. ACE's & CCB's are well-tolerated. This is thee silent killer. Compliance is 1st priority. Allhat may be all that. Would Rx'ing BB's & diuretics to Americans decrease morbidity & mortality?! Doubt it. One side effect and Seniors wonder if the corrupt major pharma's are trying to push one past them. Call their doc and get it switched! Allhat experts must think US doc's are stupid. Or, they just haven't thought this one thru. Now back the name I used: If getting union workers to do less for more money is a losing proposition, where are we heading by increasing the share of generics? From Q1 to Q208, VC's investment into life science dropped in half. Articles quoted VCs as saying their risk/return ratios suggest only the best ideas are investable. How many years before the Big 3 major pharma's come to Congress looking for a loan? Signed, Wall St Hedge Fd Analyst (1st priority is to understand macro events & profit from them... not a bias here, just watching Rome smolder and selling fire extinguishers) In 1995 the JNC V was published, documenting why BBs and diuretics should be first line. I participated in the launch of Ziac, combining the best-selling BB in EU and 6.25mg of HCl. Highest dose has placebo-level side effects with 80% efficacy. Drug didn’t hit $100m in sales. The feedback from doc’s was v telling: I can’t Rx BB & diuretics because of side effects. ACE’s & CCB’s are well-tolerated. This is thee silent killer. Compliance is 1st priority.
Allhat may be all that. Would Rx’ing BB’s & diuretics to Americans decrease morbidity & mortality?! Doubt it. One side effect and Seniors wonder if the corrupt major pharma’s are trying to push one past them. Call their doc and get it switched!
Allhat experts must think US doc’s are stupid. Or, they just haven’t thought this one thru.
Now back the name I used:
If getting union workers to do less for more money is a losing proposition, where are we heading by increasing the share of generics? From Q1 to Q208, VC’s investment into life science dropped in half. Articles quoted VCs as saying their risk/return ratios suggest only the best ideas are investable.
How many years before the Big 3 major pharma’s come to Congress looking for a loan?
Signed,
Wall St Hedge Fd Analyst
(1st priority is to understand macro events & profit from them… not a bias here, just watching Rome smolder and selling fire extinguishers)

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