Latest Drugwonks' Blog
Our pal Antoine Clarke (international editor of Pharma Marketletter) offers the following comment on today's post, "Plan B(TC)" ...
"Don’t worry, once Hillarycare gets introduced, all drugs will be either unavailable for cost reasons, or under the counter."
"Don’t worry, once Hillarycare gets introduced, all drugs will be either unavailable for cost reasons, or under the counter."
From the FDA web site ...
The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.
The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.
“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,†said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.
The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.
The U.S. Food and Drug Administration today announced the award of a two-year, $1.5 million contract to the Center for Professional Development (CPD) to assist with the transformation of FDA's Center for Drug Evaluation and Research (CDER), with a particular focus on steps to improve workplace leadership, empower staff, and establish more effective business practices.
The award to Oakland, Calif.-based CPD is part of the FDA’s ongoing response to a report issued in 2006 by the Institute of Medicine (IOM). Under the contract, CPD will help in the development of practical strategies, including training, tools, and processes that will strengthen CDER’s organizational effectiveness and reaffirm its mission of advancing and protecting the public health.
“This transformative program will provide CDER with the tools and expertise necessary to create a sustainable environment of open and transparent communication, collaborative decision-making, and improved morale and staff retention,†said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting center director.
The IOM report, The Future of Drug Safety — Promoting and Protecting the Health of the Public, identified workplace culture issues in CDER and recommended participation of external management consultants to develop a comprehensive strategy to address them. Over the past year, CDER carefully evaluated options and developed a scope of work to solicit the best outside experts to assist in transforming the workplace environment. The entire workforce of about 2,300 in CDER will be included in the workplace transformation effort. CPD will work with CDER’s senior management team and a cross-sectional working group of CDER employees to assess the center’s organizational culture, identify characteristics and a vision for CDER’s desired culture, and develop a plan for implementation and follow-up.
The FDA has announced, via the Federal Register, a November 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist."
The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.
A BTC category would almost certainly reopen the conversation about the “statin quo.â€
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
The agency wants input on issues such as whether there should be a behind-the-counter status for certain drugs and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status, where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve access to medications.
A BTC category would almost certainly reopen the conversation about the “statin quo.â€
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
CMS is now lobbying Congress (although since technically they aren’t allowed to “lobby†they will “educate" our legislators) to support their decision at a time when it is supposed to "open" to reviewing additional comments and criticisms. Hmm.
According to CMS, the basis for their NCD is that there is an absence of adequate data to determine that ESAs show "proof of no harm" and therefore will not pay for their use in most cases. The litmus test for CMS of inadequate but troubling data was the early termination of Phase IV studies of cancer drugs that used ESAs where were excess deaths.
By that definition no drug should be paid for since there is no safety study ever developed that will be proven safe. And by defining the issue in terms of safety it has deftly avoided the question of whether CMS or a doctor should weigh the risks and benefits of ESA use in combo with chemotherapy. Rather, it has used the safety issue and the "proof of no harm" threshold to assert control over the practice of medicine at the expense of doctors and their patients.
Why would it stop at just ESAs? Why not other cancer drugs that are used in off-label settings where Phase IV studies have been terminated because of an increase in deaths? (A common occurrence because many investigational studies include very sick patients.)
The CMS approach -- which dovetails with the effort to impose a comparative effectiveness measure on all new drugs much like that in the UK would bring a halt to a continuing increase in cancer survivorship and declines in death rates from all forms of cancer.
An outrageous end run around patients and clinicians? You be the judge.
According to CMS, the basis for their NCD is that there is an absence of adequate data to determine that ESAs show "proof of no harm" and therefore will not pay for their use in most cases. The litmus test for CMS of inadequate but troubling data was the early termination of Phase IV studies of cancer drugs that used ESAs where were excess deaths.
By that definition no drug should be paid for since there is no safety study ever developed that will be proven safe. And by defining the issue in terms of safety it has deftly avoided the question of whether CMS or a doctor should weigh the risks and benefits of ESA use in combo with chemotherapy. Rather, it has used the safety issue and the "proof of no harm" threshold to assert control over the practice of medicine at the expense of doctors and their patients.
Why would it stop at just ESAs? Why not other cancer drugs that are used in off-label settings where Phase IV studies have been terminated because of an increase in deaths? (A common occurrence because many investigational studies include very sick patients.)
The CMS approach -- which dovetails with the effort to impose a comparative effectiveness measure on all new drugs much like that in the UK would bring a halt to a continuing increase in cancer survivorship and declines in death rates from all forms of cancer.
An outrageous end run around patients and clinicians? You be the judge.
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.
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.
