Latest Drugwonks' Blog
Here's an interesting story by the Healthday reporter which was published in the Wash Post, Forbes, and several other places.
I was quoted extensively about neuraminidase inhibitors in the context of cautioning overuse based on FEAR, but of course avocating appropriate use.
Resistance patterns are emerging in Japan in Influenza B strains according to a new study out of the University of Tokyo.
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/03/AR2007040301282.html
I was quoted extensively about neuraminidase inhibitors in the context of cautioning overuse based on FEAR, but of course avocating appropriate use.
Resistance patterns are emerging in Japan in Influenza B strains according to a new study out of the University of Tokyo.
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/03/AR2007040301282.html
An editorial in today’s edition of the Minneapolis Star Tribune calls for consumers to “weed out conflicts in prescription drugs.â€
According to the Star Tribune ...
“If you've taken a prescription drug lately, you might be feeling a little queasy about two recent Star Tribune stories showing that hundreds of Minnesota physicians accepted millions of dollars in fees, trips and other payments from the nation's drug manufacturers. Even assuming that doctors adhere to the highest professional standards, even assuming that the drug companies have the purest motives, this has to leave the average patient wondering if he or she got the safest, cheapest, most appropriate medicine on the market -- or the one that a drug company is pushing hardest at the moment.â€
Talk about a loaded question!
But wait, it gets worse. The editorial continues …
“Consumers who are asking that question have a new ally called the Prescription Project. It's a coalition supported by Consumer Reports magazine and funded by the Pew Charitable Trusts to reduce conflicts of interest and make sure doctors are using the best unbiased research. The Minnesota Medical Association recently endorsed the website it uses to help inform consumers.â€
But the editorial fails to mention that Consumer Reports also receives significant funding from the Engleberg Foundation – whose dollars come from no less a personage than Alfred Engleberg – who has earned northward of $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits shared by generic drug makers. And, curiously enough, that funding is used to operate CR’s pharmaceutical “Savings Advisor†that offers, among other suggestions, “best buys†for Alzheimer’s medications.
An oversight on the part of the Star Tribune editorial page? Or just the most recent example of selective transparency?
Here’s a link to the full editorial:
http://www.startribune.com/561/story/1098522.html
If the Star Tribune believes that health care consumers deserve transparency, they should Gopher broke and do it right.
According to the Star Tribune ...
“If you've taken a prescription drug lately, you might be feeling a little queasy about two recent Star Tribune stories showing that hundreds of Minnesota physicians accepted millions of dollars in fees, trips and other payments from the nation's drug manufacturers. Even assuming that doctors adhere to the highest professional standards, even assuming that the drug companies have the purest motives, this has to leave the average patient wondering if he or she got the safest, cheapest, most appropriate medicine on the market -- or the one that a drug company is pushing hardest at the moment.â€
Talk about a loaded question!
But wait, it gets worse. The editorial continues …
“Consumers who are asking that question have a new ally called the Prescription Project. It's a coalition supported by Consumer Reports magazine and funded by the Pew Charitable Trusts to reduce conflicts of interest and make sure doctors are using the best unbiased research. The Minnesota Medical Association recently endorsed the website it uses to help inform consumers.â€
But the editorial fails to mention that Consumer Reports also receives significant funding from the Engleberg Foundation – whose dollars come from no less a personage than Alfred Engleberg – who has earned northward of $100 million by successfully challenging the validity and enforceability of pharmaceutical patents and has generously shared in the resulting profits shared by generic drug makers. And, curiously enough, that funding is used to operate CR’s pharmaceutical “Savings Advisor†that offers, among other suggestions, “best buys†for Alzheimer’s medications.
An oversight on the part of the Star Tribune editorial page? Or just the most recent example of selective transparency?
Here’s a link to the full editorial:
http://www.startribune.com/561/story/1098522.html
If the Star Tribune believes that health care consumers deserve transparency, they should Gopher broke and do it right.
A new Austrailian report estimates that government spending on the private health insurance rebate, which costs about $3 billion Aussie dollars a year, will grow at 4.4 per cent a year -- nearly three times the expected real growth of the economy over the next 40 years.
Sound familiar?
The opposition's health spokeswoman, Nicola Roxon, said the report showed the Government was "once again shutting its eyes to the implications of chronic disease."
"The glaring gap in the previous intergenerational report was an assessment of the impact of chronic disease and preventable disease on current health expenditure, future health expenditure, workforce participation and productivity and, staggeringly, that mistake is repeated in the report released today," Ms Roxon said.
Saying it is the first step towards addressing it. Where are the American elected officials talking about the need to focus on dealing with chronic diseases (such as diabetes, hypertension, high cholesterol, etc.)?
The single biggest recent step towards getting tens of millions of Americans properly treated for chronic disease is Part D. More seniors are being properly diagnosed and treated for chronic diseases today than ever before -- a direct result of Part D.
(A fact that, mysteriously, didn't make the recent 60 Minutes story on the MMA vote.)
Beyond Part D, however, all players in the health care game (government, pharma, providers, private payors, and John Q.Patient) need to team up to address chonic disease in ALL populations ... before we find ourselves, well, down under.
Sound familiar?
The opposition's health spokeswoman, Nicola Roxon, said the report showed the Government was "once again shutting its eyes to the implications of chronic disease."
"The glaring gap in the previous intergenerational report was an assessment of the impact of chronic disease and preventable disease on current health expenditure, future health expenditure, workforce participation and productivity and, staggeringly, that mistake is repeated in the report released today," Ms Roxon said.
Saying it is the first step towards addressing it. Where are the American elected officials talking about the need to focus on dealing with chronic diseases (such as diabetes, hypertension, high cholesterol, etc.)?
The single biggest recent step towards getting tens of millions of Americans properly treated for chronic disease is Part D. More seniors are being properly diagnosed and treated for chronic diseases today than ever before -- a direct result of Part D.
(A fact that, mysteriously, didn't make the recent 60 Minutes story on the MMA vote.)
Beyond Part D, however, all players in the health care game (government, pharma, providers, private payors, and John Q.Patient) need to team up to address chonic disease in ALL populations ... before we find ourselves, well, down under.
I don't want to say too much about this until the smoke clears, but some early observations:
1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.
2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.
3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?
it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.
1 - the drug was quite effective in some patients with severe irritable bowel symptoms esp. constipation, but many others with milder symptoms respond to miralax and fiber.
2 - 29 placebo controlled 1-3 month trials of over 11,600 patients receiving Zelnorm and over 7000 receiving placebo show a slight increase in the risk of cardiovascular events including angina, heart attacks, and strokes in those taking zelnorm - .01% on placebo, .1% on the drug, but these studies for the most part involve patients in higher risk groups than those i and others would prescribe it for and for some also a longer use of the drug.
3 - but the FDA acted quickly in its public advisory and Novartis has agreed to stop marketing the drug and selling it in the U.S. So why isn't the FDA being praised for its action on behalf of drug safety?
it makes sense to keep this drug in reserve for those in lower risk groups who really need it. It makes sense to not inflame this news and start criticizing everyone in sight. The FDA is being cautious - Novartis is being co-operative.
Can drug safety be a sometimes thing?
I pose this question based on the recent flurry of media stories on the need for new cancer treatments (see yesterday's NY Times Week in Review section) and the Abigail Alliance lawsuit that calls for greater patient access to investigational new drugs-- not to mention the debate over follow-on proteins.
(Remember, don't call them generic biologics. Words count.)
These are all important stories with significant subtexts -- most of which are entirely ignored by pols and pundits who prefer righteous indignation. Should we strive for new cancer treatment? Of course. Should patients have easier and broader access to investigational new drugs? I think yes, but there serious safety concerns that cannot just be ignored in the quest for a good headline. Follow-on proteins, same thing.
Don't get me wrong, I'm all for righteous indignation but, when it comes to drug safety, can you be for it before you are against it and still expect to be taken seriously?
Lots of well-intended verbiage in, for example Sunday's Times op-eds about the "need' without focusing on the "how," the "who," or the "how much." Many of these articles make it seem as though Big Bad Pharma is holding back on pursuing R&D for new cancer treatments because of concerns over profitability. Others blather on about Big Pharma sitting on potentially potent patents for the same reason -- with quotes from academic researchers who believe the translational gap is nothing more than the manifestation of a lazy pharmaceutical industry.
Sorry fellas -- ain't that easy.
I went through all of the articles (yesterday and today) and also did a Google search of how many times the FDA's Critical Path initiative was discussed.
Yup -- zero.
The Critical Path must not be paved with good intentions alone -- but some acknowledgement would be right and appropriate.
I pose this question based on the recent flurry of media stories on the need for new cancer treatments (see yesterday's NY Times Week in Review section) and the Abigail Alliance lawsuit that calls for greater patient access to investigational new drugs-- not to mention the debate over follow-on proteins.
(Remember, don't call them generic biologics. Words count.)
These are all important stories with significant subtexts -- most of which are entirely ignored by pols and pundits who prefer righteous indignation. Should we strive for new cancer treatment? Of course. Should patients have easier and broader access to investigational new drugs? I think yes, but there serious safety concerns that cannot just be ignored in the quest for a good headline. Follow-on proteins, same thing.
Don't get me wrong, I'm all for righteous indignation but, when it comes to drug safety, can you be for it before you are against it and still expect to be taken seriously?
Lots of well-intended verbiage in, for example Sunday's Times op-eds about the "need' without focusing on the "how," the "who," or the "how much." Many of these articles make it seem as though Big Bad Pharma is holding back on pursuing R&D for new cancer treatments because of concerns over profitability. Others blather on about Big Pharma sitting on potentially potent patents for the same reason -- with quotes from academic researchers who believe the translational gap is nothing more than the manifestation of a lazy pharmaceutical industry.
Sorry fellas -- ain't that easy.
I went through all of the articles (yesterday and today) and also did a Google search of how many times the FDA's Critical Path initiative was discussed.
Yup -- zero.
The Critical Path must not be paved with good intentions alone -- but some acknowledgement would be right and appropriate.
Regular readers of DrugWonks.com know that when pundits and pols call for FDA reform, we urge them to "Show me the money" that such efforts deserve. Mostly, we're still waiting.
Now my former FDA colleague (and current CMPI Board of Advisors member) Tomas Philipson (along with two of his colleagues from the University of Chicago) asks, in a terrific guest editorial in current edition of Health Economics, "Where is the science?"
He refers, of course, to the recent IOM study which places politics before science and rhetoric before reality.
Here's a link to the editorial:
Download file
Thoughts and comments appreciated.
Now my former FDA colleague (and current CMPI Board of Advisors member) Tomas Philipson (along with two of his colleagues from the University of Chicago) asks, in a terrific guest editorial in current edition of Health Economics, "Where is the science?"
He refers, of course, to the recent IOM study which places politics before science and rhetoric before reality.
Here's a link to the editorial:
Download file
Thoughts and comments appreciated.
In my column, Antidote, for M, M & M this month, I discuss Tekturna, the first in a very promising new class of hypertensive drugs. It is no accident that this drug has come in "under the radar" at a time when so much of the main stream media appetite involves bashing drugs and drug companies, rather than championing great discoveries. Of course this climate, while making companies paranoid to dot every "I" and cross every "T" can also negatively effect drug research both short and long term.
Happy Passover to all.
Here's the column:
ANTIDOTE: 4-07 by Marc Siegel MD
Novartis has a new drug that has just been approved by the FDA. It’s called Tekturna. It’s the first new class of hypertensive drugs in ten years, something well worth celebrating. But it’s “coming out party†has received little medical attention.
Why?
It’s not for lack of importance. Tekturna is a first of its kind once a day renin blocker. Hypertension afflicts close to one billion people worldwide, and is uncontrolled in 70%, leading to heart disease, kidney failure, and stroke.
Renin is a crucial hormonal trigger of the renin-angiotensin system which ultimately leads to the production of the important adrenal hormone aldosterone, while at the same time constricting the body’s arteries.
In a clinical trial involving 6,400 patients, Tekturna significantly lowered blood pressure for 24 hours and was also effective in combination with other medications. Considering that the renin-angiotensin system is an essential cause of high blood pressure and heart disease, and that the blockers already on the market that interfere with angiotensin-converting enzyme or block the receptor for angiotensin II have been highly successful and life saving, the need for an effective renin blocker is undisputed.
So now along comes the first drug of its kind, potentially the most powerful drug in the angiotensin axis, and no one pays attention. Is the blood thirsty zeal of drug company attackers so potent that it overwhelms and obscurs all positive reports about a new class of drugs? I’m afraid so. Is it more important to attack Merck over the rare side affect of Vioxx than to champion Novartis for breaking through with a new discovery? I definitely don’t think so.
If we want our drug companies to thrive and spend the billions necessary to break through with a new category of drugs, the least we can do is congratulate them when one succeeds. Those who make an unremitting habit of bashing drug companies about unforeseen side effects could cost them so much money and public embarrassment that it takes the legs out of important projects like the one that led to the birth of Tekturna. In the current climate, it is probably no coincidence that it took ten years to come up with a new category of blood pressure drugs.
Happy Passover to all.
Here's the column:
ANTIDOTE: 4-07 by Marc Siegel MD
Novartis has a new drug that has just been approved by the FDA. It’s called Tekturna. It’s the first new class of hypertensive drugs in ten years, something well worth celebrating. But it’s “coming out party†has received little medical attention.
Why?
It’s not for lack of importance. Tekturna is a first of its kind once a day renin blocker. Hypertension afflicts close to one billion people worldwide, and is uncontrolled in 70%, leading to heart disease, kidney failure, and stroke.
Renin is a crucial hormonal trigger of the renin-angiotensin system which ultimately leads to the production of the important adrenal hormone aldosterone, while at the same time constricting the body’s arteries.
In a clinical trial involving 6,400 patients, Tekturna significantly lowered blood pressure for 24 hours and was also effective in combination with other medications. Considering that the renin-angiotensin system is an essential cause of high blood pressure and heart disease, and that the blockers already on the market that interfere with angiotensin-converting enzyme or block the receptor for angiotensin II have been highly successful and life saving, the need for an effective renin blocker is undisputed.
So now along comes the first drug of its kind, potentially the most powerful drug in the angiotensin axis, and no one pays attention. Is the blood thirsty zeal of drug company attackers so potent that it overwhelms and obscurs all positive reports about a new class of drugs? I’m afraid so. Is it more important to attack Merck over the rare side affect of Vioxx than to champion Novartis for breaking through with a new discovery? I definitely don’t think so.
If we want our drug companies to thrive and spend the billions necessary to break through with a new category of drugs, the least we can do is congratulate them when one succeeds. Those who make an unremitting habit of bashing drug companies about unforeseen side effects could cost them so much money and public embarrassment that it takes the legs out of important projects like the one that led to the birth of Tekturna. In the current climate, it is probably no coincidence that it took ten years to come up with a new category of blood pressure drugs.
The decision by the advisory committee to both approve Provenge using subpopulation data that ODAC did not readily provide and do so by rewriting the question provided by the FDA (asking if the drug for prostate cancer was effective as opposed to asking was the drug was substantially effective for an entire population.)
And it did so despite the fact that develop Dendreon has hardly begun to enroll patients in the post market trials the FDA and its safety mongering overlords in Congress such Ed Markey, Henry Waxman and Chuck Grassley are demanding.
For this round score it: Cancer patients 1 Postuing fearmongering pols and CYA bureaucrats 0
And it did so despite the fact that develop Dendreon has hardly begun to enroll patients in the post market trials the FDA and its safety mongering overlords in Congress such Ed Markey, Henry Waxman and Chuck Grassley are demanding.
For this round score it: Cancer patients 1 Postuing fearmongering pols and CYA bureaucrats 0
Some key take-aways from yesterday’s joint Center for Medicine in the Public Interest/Old Dominion University conference on Comparative Effectiveness:
• My opening question to the panel was whether or not comparative effectiveness (aka evidence-based medicine, aka healthcare technology assessment, aka rational use of medicine) was focusing on cost rather than care. Practice variation vs. patient variation.
•Carolyn Clancy (Director of AHRQ) remarked that we need to capture clinical data from off-label prescribing.
• Scott Gottlieb pointed out that the value of studying Avastin vs. Erbitux or Actos vs. Januvia is of no value – but that studying Avastin+ Erbitux and Actos + Januvia would yield important clinical information.
In short – if you don’t ask the right questions, you won’t necessarily get the wrong answers – but you won’t get the answers that will help improve patient care on the clinical level.
There was much conversation about the relative benefits of RCTs vs real life epidemiological data (like off-label prescribing outcomes). Look at it this way – consider each separate pieces of software designed for different purposes. Both are relevant to any discussion of comparative effectiveness – but only one “software†is used – RCTs (by DERP, Consumers Union, etc.). We need to design a software interface that will allow these two data sets to “talk†with each other.
The time for puritanical allegiance to RCTs is coming to an end.
Panelists were also brutally honest when it came to the question of cost-over-care, the new health care realpolitk, agreeing that when it comes to Washington, DC – cost containment will win out over patient care every time.
Unfortunately I agree – that’s the way it is right now. But that has to change. As John Bridges (Johns Hopkins Bloomberg School of Public Health) commented, “There is no health care without the patient.â€
When it comes to changing the short term, politically-driven cost-over-care debate to a long term, patient-focused right-care-for-the-right-patient at-the-right-time paradigm, yesterday’s debate wasn’t the end, or even the beginning of the end but, hopefully, the end of the beginning.
And, when that day comes, it will indeed be health care's finest hour.
• My opening question to the panel was whether or not comparative effectiveness (aka evidence-based medicine, aka healthcare technology assessment, aka rational use of medicine) was focusing on cost rather than care. Practice variation vs. patient variation.
•Carolyn Clancy (Director of AHRQ) remarked that we need to capture clinical data from off-label prescribing.
• Scott Gottlieb pointed out that the value of studying Avastin vs. Erbitux or Actos vs. Januvia is of no value – but that studying Avastin+ Erbitux and Actos + Januvia would yield important clinical information.
In short – if you don’t ask the right questions, you won’t necessarily get the wrong answers – but you won’t get the answers that will help improve patient care on the clinical level.
There was much conversation about the relative benefits of RCTs vs real life epidemiological data (like off-label prescribing outcomes). Look at it this way – consider each separate pieces of software designed for different purposes. Both are relevant to any discussion of comparative effectiveness – but only one “software†is used – RCTs (by DERP, Consumers Union, etc.). We need to design a software interface that will allow these two data sets to “talk†with each other.
The time for puritanical allegiance to RCTs is coming to an end.
Panelists were also brutally honest when it came to the question of cost-over-care, the new health care realpolitk, agreeing that when it comes to Washington, DC – cost containment will win out over patient care every time.
Unfortunately I agree – that’s the way it is right now. But that has to change. As John Bridges (Johns Hopkins Bloomberg School of Public Health) commented, “There is no health care without the patient.â€
When it comes to changing the short term, politically-driven cost-over-care debate to a long term, patient-focused right-care-for-the-right-patient at-the-right-time paradigm, yesterday’s debate wasn’t the end, or even the beginning of the end but, hopefully, the end of the beginning.
And, when that day comes, it will indeed be health care's finest hour.
Attention Drugwonks:
The Congressional Budget Office has lowered the 10 year cost projection of the Medicare drug benefit by $387.2 billion or 32.3 percent as compared to last year's 10 year projection.
The learning is that competition and private negotiations are saving taxpayers and beneficiaries far more money than our worthy, non-partisan government actuaries had anticipated.
And in congressional testimony before the House Budget Committee, CBO Director Orzag recentlsaid that actual prescription drug plan bids for 2007 were 15 percent lower than the bids in 2006.
Imagine that -- a government program that, per capita, actually decreases in cost from year-to-year.
Competition works.
The Congressional Budget Office has lowered the 10 year cost projection of the Medicare drug benefit by $387.2 billion or 32.3 percent as compared to last year's 10 year projection.
The learning is that competition and private negotiations are saving taxpayers and beneficiaries far more money than our worthy, non-partisan government actuaries had anticipated.
And in congressional testimony before the House Budget Committee, CBO Director Orzag recentlsaid that actual prescription drug plan bids for 2007 were 15 percent lower than the bids in 2006.
Imagine that -- a government program that, per capita, actually decreases in cost from year-to-year.
Competition works.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
