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Author Archive: Howard Brody

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07/29/2014

More on Guinea Pigging–The Quality of Pharmaceutical Research

Two longish articles by our old friend Dr. Carl Elliott and by Peter Aldhous:https://medium.com/matter/did-big-pharma-test-your-meds-on-homeless-people-a6d8d3fc7dfehttps://medium.com/matter/why-are-dope-addicted-disgraced-doctors-running-our-drug-trial...

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07/28/2014

Rating New Hepattits Drugs: What Standard?

There seem to be two problems with the newest drugs for hepatitis C,  simeprevir (Olysio) and sofosbuvir (Sovaldi). The problem most discussed these days is "miracle drugs cost too much." For example, guru David Blumenthal, MD, holds forth on the Commonwealth Fund website--
http://www.commonwealthfund.org/publications/blog/2014/jul/drugs-and-dollars?omnicid=EALERT526507&mid=brody@msu.edu
--that Sovaldi is "dramatically effective and extraordinarily expensive." Robert Steinbrook and Rita F. Redberg, in an editorial in JAMA Internal Medicine, declare the new drugs "a scientific triumph". They then go on to note the problem--that Sovaldi can cost $1000 per tablet for 12 weeks' treatment, putting the cost at $84,000 ($168,000 for 24 weeks).

Our old friend Dr. Roy Poses at Health Care Renewal seems to be one of the few who's discussing a radically different problem--"maybe the drugs that cost so much are not miracle drugs at all." In his latest post: http://hcrenewal.blogspot.com/2014/07/sovaldi-quantum-leap-backwards-to-days.html--
he highlights the most recent article in JAMA, which is fawned over in an accompanying editorial despite the fact that it's non-randomized and non-controlled. Dr. Poses points out that the FDA decided to approve Sovaldi as a "breakthrough drug" which seems to have undercut the requirements that it be documented by something akin to science.

The article that accompanied the editorial in JAMA Internal Medicine addressed an evidence report by the Institute for Clinical and Economic Review, Boston, prepared for a meeting of the California Technology Assessment Forum. They concluded a need for caution regarding the two newest drugs:
"First, the evidence base on the comparative clinical effectiveness of these 2 new drugs remained thin in most areas and notably incomplete in others. For example, in some subgroups, such as patients who have failed earlier treatments, there were little or no data available. There were no long term data demonstrating the durability of short-term sustained virologic response rates for either drug; nor had either drug been compared head-to-head in a randomized clinical trial with each other or with a first-generation direct-acting antiviral drug. Finally, the evidence necessary for sofosbuvir to gain marketing approval through the FDA’s breakthrough designation was particularly sparse and did not include requirements for controlled trials." They noted that as a result of this presentation, the California forum voted the use of these drugs a "low value" for the health system.

Steinbrook and Redberg noted that Sovaldi had grossed $2.3B in the first quarter of 2014. So "low value" by one standard seems to be pretty high value by another. If the past is any indication, it will be some years before we find out which standard is the correct one; and meanwhile, the profiteers at the makers of the two drugs can expect a killing.

Steinbrook R, Redberg RF. The high price of the new hepatitis C virus drugs. JAMA Internal Medicine 174:1172, 2014.

Ollendorf DA, Tice JA, Pearson SD. The comparative clinical effectiveness and value of simeprevir and sofosbuvir for chronic hepatitis C infection. JAMA Internal Medicine 174:1170-71, 2014.





 
 
 

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07/28/2014

Rating New Hepattits Drugs: What Standard?

There seem to be two problems with the newest drugs for hepatitis C,  simeprevir (Olysio) and sofosbuvir (Sovaldi). The problem most discussed these days is "miracle drugs cost too much." For example, guru David Blumenthal, MD, holds forth on the Commonwealth Fund website--
http://www.commonwealthfund.org/publications/blog/2014/jul/drugs-and-dollars?omnicid=EALERT526507&mid=brody@msu.edu
--that Sovaldi is "dramatically effective and extraordinarily expensive." Robert Steinbrook and Rita F. Redberg, in an editorial in JAMA Internal Medicine, declare the new drugs "a scientific triumph". They then go on to note the problem--that Sovaldi can cost $1000 per tablet for 12 weeks' treatment, putting the cost at $84,000 ($168,000 for 24 weeks).

Our old friend Dr. Roy Poses at Health Care Renewal seems to be one of the few who's discussing a radically different problem--"maybe the drugs that cost so much are not miracle drugs at all." In his latest post: http://hcrenewal.blogspot.com/2014/07/sovaldi-quantum-leap-backwards-to-days.html--
he highlights the most recent article in JAMA, which is fawned over in an accompanying editorial despite the fact that it's non-randomized and non-controlled. Dr. Poses points out that the FDA decided to approve Sovaldi as a "breakthrough drug" which seems to have undercut the requirements that it be documented by something akin to science.

The article that accompanied the editorial in JAMA Internal Medicine addressed an evidence report by the Institute for Clinical and Economic Review, Boston, prepared for a meeting of the California Technology Assessment Forum. They concluded a need for caution regarding the two newest drugs:
"First, the evidence base on the comparative clinical effectiveness of these 2 new drugs remained thin in most areas and notably incomplete in others. For example, in some subgroups, such as patients who have failed earlier treatments, there were little or no data available. There were no long term data demonstrating the durability of short-term sustained virologic response rates for either drug; nor had either drug been compared head-to-head in a randomized clinical trial with each other or with a first-generation direct-acting antiviral drug. Finally, the evidence necessary for sofosbuvir to gain marketing approval through the FDA’s breakthrough designation was particularly sparse and did not include requirements for controlled trials." They noted that as a result of this presentation, the California forum voted the use of these drugs a "low value" for the health system.

Steinbrook and Redberg noted that Sovaldi had grossed $2.3B in the first quarter of 2014. So "low value" by one standard seems to be pretty high value by another. If the past is any indication, it will be some years before we find out which standard is the correct one; and meanwhile, the profiteers at the makers of the two drugs can expect a killing.

Steinbrook R, Redberg RF. The high price of the new hepatitis C virus drugs. JAMA Internal Medicine 174:1172, 2014.

Ollendorf DA, Tice JA, Pearson SD. The comparative clinical effectiveness and value of simeprevir and sofosbuvir for chronic hepatitis C infection. JAMA Internal Medicine 174:1170-71, 2014.





 
 
 

Full Article

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06/24/2014

USA: Worse than Two Countries in Health Costs

Every so often, it’s worth taking a look at how badly we’ve allowed ourselves to distort reality. We generally think that health care costs in the U.S. are about what they are in the rest of the world, or maybe just a bit worse. We seldom allow ourselves to see the true state of affairs. Accordingly, when a wake-up call comes along like the recent announcement from the Commonwealth Fund:
http://www.commonwealthfund.org/publications/fund-reports/2014/jun/mirror-mirror?omnicid=EALERT495214&mid=mh@cmwf.org
--we either don’t know what to do with it at all, or quickly look for someplace to hide.

A while ago, I was glancing at a talk given by Michael Fine, head of public health in Rhode Island. He made the interesting point that health care in the U.S., calculated on a per capita basis, costs more than it does in the United Kingdom and Japan. Let me be very clear about this: The average annual cost of health care, per person, in the UK, plus the average annual cost of health care, per person, in Japan, is less than the cost of health care, per person, in the U.S.
Maybe a few Americans have an idea that health care costs more in the U.S. than elsewhere, and that we actually get less for what we spend here than elsewhere. But I rather doubt that most Americans realize just how bad it is—that people in two other advanced nations of the world pay as much as we do per person (actually, not quite so much) for health care.

I was reminded of these figures thanks to the Commonwealth Fund’s handy reminder. They don’t include Japan in their list of 11 countries, but they give several other examples. You can assemble the figures for “almost as much as the U.S. spends on health per person per year” in several different ways:
The U.K. or Sweden or New Zealand or Australia

Plus

Canada or France or Germany

Either approach would come in less than the U.S., which tops all of the countries at $8508 per person per year. The next highest country is Norway, far back at $5669. (The first batch of countries I picked all spend between $3000 and 4000 per person per year; the second set spend between $4000 and $5000.)
The remainder of the report is not terribly auspicious for the U.S. America often spends the most money and gets the worst results. A few areas show some modest improvement since the last time the people looked, but generally things are down in the cellar and mostly staying there.

For many decades we have been used to hearing that the U.S. has “the best health care system in the world.” This has pretty much gone by the boards, though we’ll still find some dumb politico repeating it occasionally. But how far we have sunk from that status is not seen clearly by the vast majority of citizens.
Pharmaceutical costs play a relatively small role in the excessive costs of U.S. health care, making up only about 10 percent of American total health care costs. But the average American has no idea whatsoever of how incredibly pricey American health care is, compared to any other country.

Full Article

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06/24/2014

USA: Worse than Two Countries in Health Costs

Every so often, it’s worth taking a look at how badly we’ve allowed ourselves to distort reality. We generally think that health care costs in the U.S. are about what they are in the rest of the world, or maybe just a bit worse. We seldom allow ourselves to see the true state of affairs. Accordingly, when a wake-up call comes along like the recent announcement from the Commonwealth Fund:
http://www.commonwealthfund.org/publications/fund-reports/2014/jun/mirror-mirror?omnicid=EALERT495214&mid=mh@cmwf.org
--we either don’t know what to do with it at all, or quickly look for someplace to hide.

A while ago, I was glancing at a talk given by Michael Fine, head of public health in Rhode Island. He made the interesting point that health care in the U.S., calculated on a per capita basis, costs more than it does in the United Kingdom and Japan. Let me be very clear about this: The average annual cost of health care, per person, in the UK, plus the average annual cost of health care, per person, in Japan, is less than the cost of health care, per person, in the U.S.
Maybe a few Americans have an idea that health care costs more in the U.S. than elsewhere, and that we actually get less for what we spend here than elsewhere. But I rather doubt that most Americans realize just how bad it is—that people in two other advanced nations of the world pay as much as we do per person (actually, not quite so much) for health care.

I was reminded of these figures thanks to the Commonwealth Fund’s handy reminder. They don’t include Japan in their list of 11 countries, but they give several other examples. You can assemble the figures for “almost as much as the U.S. spends on health per person per year” in several different ways:
The U.K. or Sweden or New Zealand or Australia

Plus

Canada or France or Germany

Either approach would come in less than the U.S., which tops all of the countries at $8508 per person per year. The next highest country is Norway, far back at $5669. (The first batch of countries I picked all spend between $3000 and 4000 per person per year; the second set spend between $4000 and $5000.)
The remainder of the report is not terribly auspicious for the U.S. America often spends the most money and gets the worst results. A few areas show some modest improvement since the last time the people looked, but generally things are down in the cellar and mostly staying there.

For many decades we have been used to hearing that the U.S. has “the best health care system in the world.” This has pretty much gone by the boards, though we’ll still find some dumb politico repeating it occasionally. But how far we have sunk from that status is not seen clearly by the vast majority of citizens.
Pharmaceutical costs play a relatively small role in the excessive costs of U.S. health care, making up only about 10 percent of American total health care costs. But the average American has no idea whatsoever of how incredibly pricey American health care is, compared to any other country.

Full Article

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05/31/2014

The Top Five Ways that Pharma Affects You

Salon.com recently published a piece:http://www.salon.com/2014/01/25/5_evil_ways_the_multi_billion_dollar_drug_industry_is_in_bed_with_your_doctor_partner/--that cuts to the chase in the ways that the media can either bring us up to date or else pull t...

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05/31/2014

The Top Five Ways that Pharma Affects You

Salon.com recently published a piece:http://www.salon.com/2014/01/25/5_evil_ways_the_multi_billion_dollar_drug_industry_is_in_bed_with_your_doctor_partner/--that cuts to the chase in the ways that the media can either bring us up to date or else pull t...

Full Article

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05/14/2014

Are KOLs drying up? Praise be


Back in 2011 I heard from Cutting Edge Information on the subject of key opinion leaders (KOLs):
I figured that once I outed them on this blog, they would know better than to send me any more e-mails, but apparently they are still at it; the cold-call e-mail that’s reprinted below arrived this week. The content would seem to suggest that Pharma firms are having greater difficulties finding “Key opinion leader” physicians (aka shills) due to the increased transparency requirements of the pending Sunshine Act. If this is the case, then of course it is what I have been advocating for years. I read both the e-mail and the attached detailed brochure but could not find a figure as to the actual cost of this 179-page report, so you’ll have to contact Cutting Edge Information directly if you want to buy a copy. (I have a feeling there might be some sticker shock…)

Unsolicited E-mail message:

Howard,

Key opinion leading physicians face pressure from increasing transparency via the Sunshine Act and organizational restrictions on pharma-physician relationships. Has your organization made the strategic, resource and operational shifts necessary to compete for KOL services in this new environment?

Cutting Edge Information worked closely with senior-level medical and KOL management executives at more than 30 leading pharmaceutical and biotech companies to distill the latest strategies, benchmark data, executive insights and best practices that are enabling the top-performing KOL management organizations to continue to achieve results for their companies in our new report, “Pharmaceutical Key Opinion Leader Management: Effective Strategies for Segmenting Thought Leaders.” Use this report to:

• Benchmark extensive, deep thought leader segmentation data and analysis
• Prepare your KOL management team(s) to combat shrinking KOL pools
• Leverage third-party vendors’ expertise to develop and refresh robust thought leader directories
• Reach beyond traditional specialist KOLs to fill out thought leader listings
• Compare your company’s organizational structure, staffing and budget support to those of your peers and competitors

I have attached a summary document with more details about this new report for your review. I would appreciate the opportunity to answer your questions about how this report will be of value to you and your organization. Please call me directly at +1-919-433-0211 or reply by email. I look forward to hearing from you soon.


REPORT SUMMARY:
Pharmaceutical Key Opinion Leader Management: Effective Strategies for Segmenting Thought Leaders
Pages: 178
Data Charts/Tables: 95+
Metrics: 500-plus
Companies Consulted: more than 30, including Boehringer Ingelheim, CSL Behring, Ferring, Novo Nordisk and Sanofi


ADDITIONAL MEDICAL AFFAIRS REPORTS:

For more information on any of our other medical affairs reports below, please reply by email and I will be happy to send a brochure:

1. Pharmaceutical Advisory Boards: Uncovering Clinical, Market and Payer Insights to Enrich Product Opportunities
2. Promotional Speaker Programs: Successfully Managing Speaker Bureaus and Recruiting Thought Leaders
3. Educational Speaker Programs: Medical Event Management and Recruitment in a Complex Regulatory Environment
4. MSL Activities and Performance Measurement: Harnessing KOL Relationships for Optimal Clinical Support
5. Managing MSL Teams: Budget, Staffing and Compensation Benchmarks
6. Medical Information Teams and Call Center Management


Kind Regards,

Jon Hess
Account Executive, Cutting Edge Information
1000 Park Forty Plaza, Durham, NC 27713
O: (919) 433-0211 | F: (919) 433-0220
Jon_hess@cuttingedgeinfo.com| www.cuttingedgeinfo.com

Full Article

This entry was posted in Health Care and tagged . Posted by Howard Brody. Bookmark the permalink.

05/14/2014

Are KOLs drying up? Praise be


Back in 2011 I heard from Cutting Edge Information on the subject of key opinion leaders (KOLs):
I figured that once I outed them on this blog, they would know better than to send me any more e-mails, but apparently they are still at it; the cold-call e-mail that’s reprinted below arrived this week. The content would seem to suggest that Pharma firms are having greater difficulties finding “Key opinion leader” physicians (aka shills) due to the increased transparency requirements of the pending Sunshine Act. If this is the case, then of course it is what I have been advocating for years. I read both the e-mail and the attached detailed brochure but could not find a figure as to the actual cost of this 179-page report, so you’ll have to contact Cutting Edge Information directly if you want to buy a copy. (I have a feeling there might be some sticker shock…)

Unsolicited E-mail message:

Howard,

Key opinion leading physicians face pressure from increasing transparency via the Sunshine Act and organizational restrictions on pharma-physician relationships. Has your organization made the strategic, resource and operational shifts necessary to compete for KOL services in this new environment?

Cutting Edge Information worked closely with senior-level medical and KOL management executives at more than 30 leading pharmaceutical and biotech companies to distill the latest strategies, benchmark data, executive insights and best practices that are enabling the top-performing KOL management organizations to continue to achieve results for their companies in our new report, “Pharmaceutical Key Opinion Leader Management: Effective Strategies for Segmenting Thought Leaders.” Use this report to:

• Benchmark extensive, deep thought leader segmentation data and analysis
• Prepare your KOL management team(s) to combat shrinking KOL pools
• Leverage third-party vendors’ expertise to develop and refresh robust thought leader directories
• Reach beyond traditional specialist KOLs to fill out thought leader listings
• Compare your company’s organizational structure, staffing and budget support to those of your peers and competitors

I have attached a summary document with more details about this new report for your review. I would appreciate the opportunity to answer your questions about how this report will be of value to you and your organization. Please call me directly at +1-919-433-0211 or reply by email. I look forward to hearing from you soon.


REPORT SUMMARY:
Pharmaceutical Key Opinion Leader Management: Effective Strategies for Segmenting Thought Leaders
Pages: 178
Data Charts/Tables: 95+
Metrics: 500-plus
Companies Consulted: more than 30, including Boehringer Ingelheim, CSL Behring, Ferring, Novo Nordisk and Sanofi


ADDITIONAL MEDICAL AFFAIRS REPORTS:

For more information on any of our other medical affairs reports below, please reply by email and I will be happy to send a brochure:

1. Pharmaceutical Advisory Boards: Uncovering Clinical, Market and Payer Insights to Enrich Product Opportunities
2. Promotional Speaker Programs: Successfully Managing Speaker Bureaus and Recruiting Thought Leaders
3. Educational Speaker Programs: Medical Event Management and Recruitment in a Complex Regulatory Environment
4. MSL Activities and Performance Measurement: Harnessing KOL Relationships for Optimal Clinical Support
5. Managing MSL Teams: Budget, Staffing and Compensation Benchmarks
6. Medical Information Teams and Call Center Management


Kind Regards,

Jon Hess
Account Executive, Cutting Edge Information
1000 Park Forty Plaza, Durham, NC 27713
O: (919) 433-0211 | F: (919) 433-0220
Jon_hess@cuttingedgeinfo.com| www.cuttingedgeinfo.com

Full Article

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05/05/2014

The Ongoing Statin Debate, or Is It?

Those of you who are heartily sick of my talking about statins, please skip this post.By way of joining in on the controversial new statin guidelines:http://brodyhooked.blogspot.com/2013/11/new-cholesterol-guidelinesthe-devil-in.html--the New England J...

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