Latest Drugwonks' Blog
During his keynote address at Cleveland Clinic's 2007 Medical Innovations Summit, Lilly CEO Sidney Taurel challenged the health-care industry, medical community and U.S. government to work more closely to bring about a "true information revolution in health care."
"The time is ripe for FDA, the health care industry, and the medical community to collaborate on a reform of our nation's pharmacovigilance system. Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly," said Taurel.
"The use of prescription medicines always will be a matter of balancing benefits and risks. Frankly, that's the first and most basic insight that needs to be understood by health-care consumers, not to mention the news media and politicians.â€
"Not to mention," indeed.
"Fortunately, systems are now within our grasp to much more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use."
His call for an information overhaul comes as the national health-care system is getting increased scrutiny by patients, regulators and politicians. Nearly all of the announced 2008 presidential candidates are calling for better medical record-keeping and wider sharing of information to cut costs and improve care.
Not that anyone really understands what any of those plans are or what they say, or how they will be paid for. But that's another issue altogether.
And credit where credit is due, three years ago, Lilly became the first to disclose the results of all its clinical trials on the Internet.
Taurel singled out some groups that are swiftly moving to share health information, including the Indiana Health Information Exchange, a network used by 27 hospitals and 5,200 physicians to share the results of laboratory tests. The exchange allows physicians to see immediately whether their patients have had tests done elsewhere, and if so, what the results were, to avoid duplication and provide better care.
Lilly also is working with competitors Pfizer and Johnson & Johnson on a project to understand how to find telling information about drugs in large databases. The move comes as Lilly and other drug companies are focusing more and more on personalized medicine, trying to tailor medicines to smaller groups of patients with certain genetic predispositions or health conditions.
"Certainly, at Lilly, we spend hundreds of millions of dollars every year on clinical trials," Taurel's speech says. "But the key insight in our situation, and I think it applies quite broadly, is that unlike most other assets, health information actually becomes more valuable the more it is used, studied and applied. It does not depreciate."
Amen Brother Sidney.
"The time is ripe for FDA, the health care industry, and the medical community to collaborate on a reform of our nation's pharmacovigilance system. Such reform will allow us to speed up the recognition of safety signals and understand the true efficacy of new medicines more quickly," said Taurel.
"The use of prescription medicines always will be a matter of balancing benefits and risks. Frankly, that's the first and most basic insight that needs to be understood by health-care consumers, not to mention the news media and politicians.â€
"Not to mention," indeed.
"Fortunately, systems are now within our grasp to much more quickly identify both the true benefits and the full extent of risks associated with medicines in widespread use."
His call for an information overhaul comes as the national health-care system is getting increased scrutiny by patients, regulators and politicians. Nearly all of the announced 2008 presidential candidates are calling for better medical record-keeping and wider sharing of information to cut costs and improve care.
Not that anyone really understands what any of those plans are or what they say, or how they will be paid for. But that's another issue altogether.
And credit where credit is due, three years ago, Lilly became the first to disclose the results of all its clinical trials on the Internet.
Taurel singled out some groups that are swiftly moving to share health information, including the Indiana Health Information Exchange, a network used by 27 hospitals and 5,200 physicians to share the results of laboratory tests. The exchange allows physicians to see immediately whether their patients have had tests done elsewhere, and if so, what the results were, to avoid duplication and provide better care.
Lilly also is working with competitors Pfizer and Johnson & Johnson on a project to understand how to find telling information about drugs in large databases. The move comes as Lilly and other drug companies are focusing more and more on personalized medicine, trying to tailor medicines to smaller groups of patients with certain genetic predispositions or health conditions.
"Certainly, at Lilly, we spend hundreds of millions of dollars every year on clinical trials," Taurel's speech says. "But the key insight in our situation, and I think it applies quite broadly, is that unlike most other assets, health information actually becomes more valuable the more it is used, studied and applied. It does not depreciate."
Amen Brother Sidney.
She works hard with nary a word of praise, takes a lot of abuse and shoulders a heavy burden without complaint (mostly). So permit us to gush for a moment.
From the FDA web site ...
FDA's Dr. Janet Woodcock Honored by Alliance for Aging Research for Improving Healthy Aging
Named Indispensable Person of the Year for Health Research
The Alliance for Aging Research has chosen Janet Woodcock, M.D., FDA's deputy commissioner and chief medical officer, as the Indispensable Person of the Year for Health Research, for effective, innovative and ethical leadership.
Dr. Woodcock leads FDA's Critical Path Initiative, which is designed to improve the scientific bases for developing, evaluating, and manufacturing FDA-regulated products. In addition, she serves as the point person for a team of FDA scientists and policymakers who have been working on strategies to improve drug safety monitoring and the development pathway for treatments of disorders such as Alzheimer's disease that are associated with aging.
The Alliance presented the awards at its 14th Annual Bipartisan Congressional Awards Dinner earlier this month in Washington, DC.
A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award and other scientific awards, as well as six Special Citations from FDA Commissioners.
The Alliance is a nonprofit organization that promotes scientific and medical research for healthier aging.
From the FDA web site ...
FDA's Dr. Janet Woodcock Honored by Alliance for Aging Research for Improving Healthy Aging
Named Indispensable Person of the Year for Health Research
The Alliance for Aging Research has chosen Janet Woodcock, M.D., FDA's deputy commissioner and chief medical officer, as the Indispensable Person of the Year for Health Research, for effective, innovative and ethical leadership.
Dr. Woodcock leads FDA's Critical Path Initiative, which is designed to improve the scientific bases for developing, evaluating, and manufacturing FDA-regulated products. In addition, she serves as the point person for a team of FDA scientists and policymakers who have been working on strategies to improve drug safety monitoring and the development pathway for treatments of disorders such as Alzheimer's disease that are associated with aging.
The Alliance presented the awards at its 14th Annual Bipartisan Congressional Awards Dinner earlier this month in Washington, DC.
A prominent FDA scientist and executive, Dr. Woodcock has received numerous awards, including a Presidential Rank Meritorious Executive Award and other scientific awards, as well as six Special Citations from FDA Commissioners.
The Alliance is a nonprofit organization that promotes scientific and medical research for healthier aging.
The word “fora†is the plural of "forum." The dictionary definition of forum is: the public square or marketplace of an ancient Roman city that was the assembly place for judicial activity and public business.
FORA.tv delivers discourse, discussions and debates on the world's most interesting political, social and cultural issues, and enables viewers to join the conversation. It provides deep, unfiltered content, tools for self-expression and a place for the interactive community to gather online.
Last week, at the 2007 Georgia Health Care Symposium, I shared the podium with, among others, former HHS Secretary, Dr. Louis Sullivan and Georgia Lt. Governor Casey Cagle.
Dr.Sullivan spoke eloquently on the need for a "symphony†of health care. I spoke, bluntly, about a “sym-phoney†of health care as defined by the three biggest lies in American health care:
* That cost is more important than care (and government know better than physicians what’s best for patients)
* That we use too many medicines (and it’s acceptable to let politics trump public health)
* That we have too many medicines (the myth of me-tooism)
My main point was (and is) that focusing on Practice Variation over Patient Variation neuters physicians and makes them nothing more than Medo-Crats.
The event was hosted by the Georgia Public Policy Foundation and captured on video by FORA.tv. The complete seminar can be found by clicking on this link:
http://cmpi.org/archives/2007/09/2007_georgia_health_care_sympo.php
It’s “must think†TV.
FORA.tv delivers discourse, discussions and debates on the world's most interesting political, social and cultural issues, and enables viewers to join the conversation. It provides deep, unfiltered content, tools for self-expression and a place for the interactive community to gather online.
Last week, at the 2007 Georgia Health Care Symposium, I shared the podium with, among others, former HHS Secretary, Dr. Louis Sullivan and Georgia Lt. Governor Casey Cagle.
Dr.Sullivan spoke eloquently on the need for a "symphony†of health care. I spoke, bluntly, about a “sym-phoney†of health care as defined by the three biggest lies in American health care:
* That cost is more important than care (and government know better than physicians what’s best for patients)
* That we use too many medicines (and it’s acceptable to let politics trump public health)
* That we have too many medicines (the myth of me-tooism)
My main point was (and is) that focusing on Practice Variation over Patient Variation neuters physicians and makes them nothing more than Medo-Crats.
The event was hosted by the Georgia Public Policy Foundation and captured on video by FORA.tv. The complete seminar can be found by clicking on this link:
http://cmpi.org/archives/2007/09/2007_georgia_health_care_sympo.php
It’s “must think†TV.
Agree or disagree, the FierceHealthcare/pharma/biotech dailies and their editors do the some of the best reporting and analysis anywhere. I love their editorials and commentary -- especially when I don't agree or am introduced to a new trend -- because they force a careful rethinking and readjusting based on facts, events and insights on health care and science. I learn a lot.
Case in point, Anne Zeiger's commentary on Wal-Mart's movement into health care. Zieger called this trend months ahead of everyone and her coverage is the most comprehensive insightful of anyone writing about this stuff.
"About a year ago I suggested, half tongue-in-cheek, that Wal-Mart might want to go into the business of providing healthcare services. The idea remains intriguing to me, particularly as Wal-Mart ramps up its retail clinics and cheap meds initiative.
As you probably know (if you haven't been under a rock for a year or two), Wal-Mart has rolled out a program under which it offers hundreds of commonly-used generic drugs for a flat $4 per prescription. The program has sparked copycat programs from rival retailers, generated a lot of talk and probably saved some patients some bucks. This week, it's extending the program to cover new types of drugs (such as an ADHD med), and what's more, has established a $9 tier which will allow it to broaden its offerings.
To me, this has implications well beyond the retail pharmacy sector. Not only will such moves continue to push business into the Wal-Mart pharmacies, they could indirectly support the retail clinic businesses emerging in its stores over the next few years. With price-conscious consumers already hitting the stores for retail healthcare, getting cheap medication makes a lot of sense.
What I'm getting at, here, is that offering cheap meds is likely to be followed by other strategies that cement Wal-Mart's position as an outpatient healthcare destination, such as clinical testing. Future enhancements could even include non-retail activities--probably, in partnership with local hospitals--such as community healthcare education programs or blood pressure screenings.
I admit I could be reading this all wrong, and that all Wal-Mart cares about is to generate more transactions for its core retail businesses. But when you consider that it's planning to launch 2,000 retail clinics in coming years, maybe the idea of Wal-Mart as provider isn't such a wacky notion. Sure, Wal-Mart has no experience offering healthcare services today, but somehow, I doubt that will stop 'em."
(Thanks Anne. And think transfusions too.)
http://www.fiercehealthcare.com
Case in point, Anne Zeiger's commentary on Wal-Mart's movement into health care. Zieger called this trend months ahead of everyone and her coverage is the most comprehensive insightful of anyone writing about this stuff.
"About a year ago I suggested, half tongue-in-cheek, that Wal-Mart might want to go into the business of providing healthcare services. The idea remains intriguing to me, particularly as Wal-Mart ramps up its retail clinics and cheap meds initiative.
As you probably know (if you haven't been under a rock for a year or two), Wal-Mart has rolled out a program under which it offers hundreds of commonly-used generic drugs for a flat $4 per prescription. The program has sparked copycat programs from rival retailers, generated a lot of talk and probably saved some patients some bucks. This week, it's extending the program to cover new types of drugs (such as an ADHD med), and what's more, has established a $9 tier which will allow it to broaden its offerings.
To me, this has implications well beyond the retail pharmacy sector. Not only will such moves continue to push business into the Wal-Mart pharmacies, they could indirectly support the retail clinic businesses emerging in its stores over the next few years. With price-conscious consumers already hitting the stores for retail healthcare, getting cheap medication makes a lot of sense.
What I'm getting at, here, is that offering cheap meds is likely to be followed by other strategies that cement Wal-Mart's position as an outpatient healthcare destination, such as clinical testing. Future enhancements could even include non-retail activities--probably, in partnership with local hospitals--such as community healthcare education programs or blood pressure screenings.
I admit I could be reading this all wrong, and that all Wal-Mart cares about is to generate more transactions for its core retail businesses. But when you consider that it's planning to launch 2,000 retail clinics in coming years, maybe the idea of Wal-Mart as provider isn't such a wacky notion. Sure, Wal-Mart has no experience offering healthcare services today, but somehow, I doubt that will stop 'em."
(Thanks Anne. And think transfusions too.)
http://www.fiercehealthcare.com
The Patent Reform Act of 2007 (S. 1145) seeks to “harmonize†the American patent system with those of other nations. But, as Kevin Kearns of the U.S. Business and Industry Council has written, “do we really need to be "harmonized" with a calcified European system or the impossibly unfair Japanese system, not to mention the Chinese system, where intellectual property theft is a way of life?â€
Bottom line is that the pending legislation would make it harder for patent holders to enforce their rights or win just compensation from those who infringe their rights. It would be harder to prove "willful" infringement, which entails punitive damages. The bill also includes a mandatory apportionment test that would lessen the value assigned to patents in most products.
Not only would the bill reduce the value of patents, but it would facilitate patent theft.
Under our current system, inventors can "opt-out" of having their application published by filing "only" in the United States and not in another country where it can be ripped off. The current bill would eliminate the opt-out provision.
Think “health care innovation.†Then think “India.â€
According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without robust intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.
There are precious few “Eureka!†occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, that’s how health care progress is made – not through Hollywood-style “Aha!†moments so popular with politicians and pundits.
Does our patent system need reform? That’s a question for patent experts. Should we facilitate a patent system that disincentivizes pharmaceutical innovation? That’s a no-brainer.
Bottom line is that the pending legislation would make it harder for patent holders to enforce their rights or win just compensation from those who infringe their rights. It would be harder to prove "willful" infringement, which entails punitive damages. The bill also includes a mandatory apportionment test that would lessen the value assigned to patents in most products.
Not only would the bill reduce the value of patents, but it would facilitate patent theft.
Under our current system, inventors can "opt-out" of having their application published by filing "only" in the United States and not in another country where it can be ripped off. The current bill would eliminate the opt-out provision.
Think “health care innovation.†Then think “India.â€
According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without robust intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.
There are precious few “Eureka!†occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, that’s how health care progress is made – not through Hollywood-style “Aha!†moments so popular with politicians and pundits.
Does our patent system need reform? That’s a question for patent experts. Should we facilitate a patent system that disincentivizes pharmaceutical innovation? That’s a no-brainer.
President Bush signed the FDA reform bill into law today. Now we'll see who gains control of the future of drug regulation: those who support personalized medicine and develop tools to make medicines safer and more effective by tailoring treatments to those best suited for them. Or the plaintiffs priesthood, the Grahams, the Avorns, the Nissens, the Furbergs who will cherry pick clinical trial data on the trial attorney/Soros/Public Citizen/ dime. The choice is between those who want to really reduce risk through better science and those who want to distort data to make us more afraid.
Our friends at the C-Path Institute have blazed that trail of personalized drug safety. Go to the C-Path website..it is full of initiatives and partnerships with the FDA. Ditto the folks at BG Medicine who have a CRADA with the FDA on a liver tox biomarker. Then there is the work of Dr. Ruano (that I have benefitted from directly -- put that in there because I know my critics just hate when I use personal examples ) with regard to side effects from statins at Genomas.
As Ray Woosley of C-Path asks about Personalized Medicine. When? Why Not Now?
http://www.cpath-institute.org
http://www.bgmedicine.com
http://www.genomas.net
As Ray Woosley of C-Path asks about Personalized Medicine. When? Why Not Now?
http://www.cpath-institute.org
http://www.bgmedicine.com
http://www.genomas.net
From today's edition of the Wall Street Journal ...
Consortium to Study Genetics, Drug Safety
By JENNIFER CORBETT DOOREN
WASHINGTON -- A group of seven pharmaceutical companies and academic institutions today will announce an alliance designed to look for genetic links to safety problems associated with medicines.
The group, known as the International Serious Adverse Events Consortium, will launch two studies to look for genetic markers that researchers hope will predict which people are at risk for serious drug-related adverse events.
The first study, with results tentatively slated for release about a year from now, will look at whether variations in a person's DNA are responsible for the development of a rare drug-related skin condition known as Stevens-Johnson Syndrome. Stevens-Johnson is typically marked by a painful, blistering skin rash that causes the top layer of the skin to die. It can be fatal if a person is exposed to the drug that initially caused Stevens-Johnson again.
The second study will look at genetic variations behind serious drug-induced liver injury. Arthur Holden, a former Baxter International Inc. executive who is chairman of the consortium, said he hoped results from that study would be available in two years.
"Everyone's talking about drug safety, and this is what we need to do to improve drug safety," Mr. Holden said in an interview. The seven companies, Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer Inc., Roche Holding AG, Sanofi-Aventis SA and Wyeth are providing "millions" of dollars for the research effort, he said.
The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis. The DNA from the individuals with side effects will be compared with DNA from "control" subjects who didn't have drug side effects to see if there are genetic variations among the two groups.
Mr. Holden said that if the first two studies are successful, the consortium would then move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class.
The data from the consortium will be made public and could be used by government regulators such as the Food and Drug Administration.
Janet Woodcock, the FDA's chief medical officer, will work with the consortium, although the agency isn't formally a member. "We want this kind of information," she said of the genetic studies, so the agency can find ways to prevent drug side effects or to better manage them. Dr. Woodcock said it is possible that FDA regulations and guidelines on drug development and approval could change if the studies yield clear results.
Many serious drug side effects, such as an increased risk for heart attacks and strokes seen with Merck & Co.'s withdrawn painkiller Vioxx, don't become apparent until after drugs hit the market and thousands or millions more people are exposed. Most clinical studies used to gain approval for a drug involve several hundred to a few thousand patients.
Already, the FDA is highlighting genetic information to help doctors and patients manage drug side effects. Last month alone, the agency said as many as one-third of people on the blood-thinning drug warfarin metabolize the drug differently than expected and warned that breast-feeding women on painkillers with codeine could expose the infant to too much codeine if they are "ultra-rapid" metabolizers of the drug. However, the FDA stopped short of recommending that patients undergo genetic testing to see how they might process the drugs
Consortium to Study Genetics, Drug Safety
By JENNIFER CORBETT DOOREN
WASHINGTON -- A group of seven pharmaceutical companies and academic institutions today will announce an alliance designed to look for genetic links to safety problems associated with medicines.
The group, known as the International Serious Adverse Events Consortium, will launch two studies to look for genetic markers that researchers hope will predict which people are at risk for serious drug-related adverse events.
The first study, with results tentatively slated for release about a year from now, will look at whether variations in a person's DNA are responsible for the development of a rare drug-related skin condition known as Stevens-Johnson Syndrome. Stevens-Johnson is typically marked by a painful, blistering skin rash that causes the top layer of the skin to die. It can be fatal if a person is exposed to the drug that initially caused Stevens-Johnson again.
The second study will look at genetic variations behind serious drug-induced liver injury. Arthur Holden, a former Baxter International Inc. executive who is chairman of the consortium, said he hoped results from that study would be available in two years.
"Everyone's talking about drug safety, and this is what we need to do to improve drug safety," Mr. Holden said in an interview. The seven companies, Abbott Laboratories, GlaxoSmithKline PLC, Johnson & Johnson, Pfizer Inc., Roche Holding AG, Sanofi-Aventis SA and Wyeth are providing "millions" of dollars for the research effort, he said.
The consortium will collect and combine already existing data on serious liver side effects, tissue samples housed in two Britain-based academic institutions, and information and DNA samples from at least one pharmaceutical firm on Stevens-Johnson Syndrome and a related skin condition known as toxic epidermal necrolysis. The DNA from the individuals with side effects will be compared with DNA from "control" subjects who didn't have drug side effects to see if there are genetic variations among the two groups.
Mr. Holden said that if the first two studies are successful, the consortium would then move to other serious side effects like heart trouble and kidney damage that are linked to several different types of drugs as well as drugs in the same class.
The data from the consortium will be made public and could be used by government regulators such as the Food and Drug Administration.
Janet Woodcock, the FDA's chief medical officer, will work with the consortium, although the agency isn't formally a member. "We want this kind of information," she said of the genetic studies, so the agency can find ways to prevent drug side effects or to better manage them. Dr. Woodcock said it is possible that FDA regulations and guidelines on drug development and approval could change if the studies yield clear results.
Many serious drug side effects, such as an increased risk for heart attacks and strokes seen with Merck & Co.'s withdrawn painkiller Vioxx, don't become apparent until after drugs hit the market and thousands or millions more people are exposed. Most clinical studies used to gain approval for a drug involve several hundred to a few thousand patients.
Already, the FDA is highlighting genetic information to help doctors and patients manage drug side effects. Last month alone, the agency said as many as one-third of people on the blood-thinning drug warfarin metabolize the drug differently than expected and warned that breast-feeding women on painkillers with codeine could expose the infant to too much codeine if they are "ultra-rapid" metabolizers of the drug. However, the FDA stopped short of recommending that patients undergo genetic testing to see how they might process the drugs
I forgot to mention (because it's beaten into the mainstream mindset that only free market thinkers can be "conflicted")) that the comparative effectiveness crowd has some conflicts of their own, starting with the fact that they are funded by insurance companies. But I guess taking money from organizations that switch people from one molocule to another without telling patients is okay for bloggers like Health Care Renewal. The science linking statin response to genetic mutation is pretty compelling -- but maybe HCR wants to challenge the science in this area too?
Then there is the trial attorney/Soros/Avorn connection that is never disclosed. Drugwonks posted on that previously.
http://drugwonks.com/2007/02/iom_safety_committee_conflicted_and_confused.html
Then there is the trial attorney/Soros/Avorn connection that is never disclosed. Drugwonks posted on that previously.
http://drugwonks.com/2007/02/iom_safety_committee_conflicted_and_confused.html
“If you want to save money and save lives, the "switching" we need in the United States is a one from a focus on acute care to one on chronic care.â€
So begins a new op-ed in The Journal of Life Sciences.
The complete article can be found at:
http://www.tjols.com/article-289.html
To cut healthcare costs, we need to focus on early treatment of chronic conditions, rather than force patients to switch to generic alternatives that may not be equivalent to the medicines they are using.
The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too†medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.
So begins a new op-ed in The Journal of Life Sciences.
The complete article can be found at:
http://www.tjols.com/article-289.html
To cut healthcare costs, we need to focus on early treatment of chronic conditions, rather than force patients to switch to generic alternatives that may not be equivalent to the medicines they are using.
The repercussions of choosing short-term thinking over long-term results, of short-term cost-based choices over patient-based care, of “me-too†medicines over the right medicine for the right patient at the right time—are pernicious to both the public purse as well as the public health.
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.
