Latest Drugwonks' Blog
"We started during the Clinton administration to transition the VA system to a paperless system....The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning."
Hillary Clinton
"If you take a look at how the VHA system works, it's much more flexible getting drugs that are not on the list than the private plans are. And so people get the worst of all worlds: They have a more rigid formulary under Medicare, and the prices are much higher."
Ron Pollack FUSA
"Who do you think receives higher-quality health care. Medicare patients who are free to pick their own doctors and specialists? Or aging veterans stuck in those presumably filthy VA hospitals with their antiquated equipment, uncaring administrators, and incompetent staff? An answer came in 2003, when the prestigious New England Journal of Medicine published a study that compared veterans health facilities on 11 measures of quality with fee-for-service Medicare. On all 11 measures, the quality of care in veterans facilities proved to be "significantly better."
Philip Longman, Washington Monthly, 2005 from an article The Best Care Anywhere that boasted: "Ten years ago, veterans hospitals were dangerous, dirty, and scandal-ridden. Today, they're producing the highest quality care in the country. Their turnaround points the way toward solving America's health-care crisis."
Hillary Clinton
"If you take a look at how the VHA system works, it's much more flexible getting drugs that are not on the list than the private plans are. And so people get the worst of all worlds: They have a more rigid formulary under Medicare, and the prices are much higher."
Ron Pollack FUSA
"Who do you think receives higher-quality health care. Medicare patients who are free to pick their own doctors and specialists? Or aging veterans stuck in those presumably filthy VA hospitals with their antiquated equipment, uncaring administrators, and incompetent staff? An answer came in 2003, when the prestigious New England Journal of Medicine published a study that compared veterans health facilities on 11 measures of quality with fee-for-service Medicare. On all 11 measures, the quality of care in veterans facilities proved to be "significantly better."
Philip Longman, Washington Monthly, 2005 from an article The Best Care Anywhere that boasted: "Ten years ago, veterans hospitals were dangerous, dirty, and scandal-ridden. Today, they're producing the highest quality care in the country. Their turnaround points the way toward solving America's health-care crisis."
Today the Senate reintroduce legislation to require the FDA insure that packages, wholesalers and manufacturing plants in Europe -- all old drugs of course -- are safe. The bill also requires the FDA to claim that drugs with different coatings, formulations, doses but same active ingredients are as safe and effective as products made to US spec.
Earlier this week, the Senate introduced a bill that would require the FDA to come up with a standard and process for approving -- I am not making this one up -- a safe cigarette.
Previously, Congress introduced a bill requiring the FDA to approve certain knock-off versions of biotech drugs as generic and as interchangeable without any safety tests or risk management or life cycle management strategies,
Previously still, legislation was introduced which required the FDA to set up a risk management program for every drug on the market and every new one being developed...except for imported drugs and generic biologics.
The FDA is still responsible for approving new medicines. I think.
But not until they improve spinach inspection and beef up labeling on peanut butter and organic foods.
Earlier this week, the Senate introduced a bill that would require the FDA to come up with a standard and process for approving -- I am not making this one up -- a safe cigarette.
Previously, Congress introduced a bill requiring the FDA to approve certain knock-off versions of biotech drugs as generic and as interchangeable without any safety tests or risk management or life cycle management strategies,
Previously still, legislation was introduced which required the FDA to set up a risk management program for every drug on the market and every new one being developed...except for imported drugs and generic biologics.
The FDA is still responsible for approving new medicines. I think.
But not until they improve spinach inspection and beef up labeling on peanut butter and organic foods.
Let's say you are a leading clinician researcher in the area of auto-immune disorders and a new drug for rheumatoid arthritis has a risk management program attached to it that limits prescribing to patients with RA and to RA specialists. However because of the drug works on a particular pathway you, because of previous research, have a hunch, it will work fine on patients with lupus. Or what if you want to use a new antibiotic to suppress an infection in CF patients but the RIskmap plan limits it to organ rejection use. If you use it (or if you can even get it) for an off-the-map purpose are you liable, criminally or civilly? Could you lose your medical license? Do patients have to wait to enroll in a clinical trial for every novel use? Will medical innovation grind to a halt? Will patients die because they are not on The MAP?
For all those eager to kill off the US pharma industry, no need to worry, Cuba is filling the void with an ambitious program to find a use for coca leaves for every ailment. Who needs stem cells when you have the precursor for cocaine from Castro's labs?
Scientists seek coca's medical benefits
By DAN KEANE, Associated Press Writer Tue Mar 6, 6:54 PM ET
LA PAZ, Bolivia - Cuban scientists are studying the possible medicial benefits of the coca leaf, a Bolivian official said Tuesday, signaling a possible expansion of President Evo Morales' plans to develop more legal products from a plant that is the chief ingredient of cocaine.
http://news.yahoo.com/s/ap/20070306/ap_on_sc/bolivia_cuba_coca
Scientists seek coca's medical benefits
By DAN KEANE, Associated Press Writer Tue Mar 6, 6:54 PM ET
LA PAZ, Bolivia - Cuban scientists are studying the possible medicial benefits of the coca leaf, a Bolivian official said Tuesday, signaling a possible expansion of President Evo Morales' plans to develop more legal products from a plant that is the chief ingredient of cocaine.
http://news.yahoo.com/s/ap/20070306/ap_on_sc/bolivia_cuba_coca
I have created a new category in honor of Scott Gottlieb's latest and greatest oped in the Wall Street Journal. (See Peter's post below) This will catalog the various efforts of Washington types to politicize science or regulate the practice of medicine according to a specific ideological agenda without debate or transparency or regard to science. The gold standard for such meddling or micromanagement will likely be a battle between Waxman and David Graham now that Senator Grassley is in the minority.
Here's the first entry of the spring training season for this :
Congressional Panel to Study
Off-Label Use of Stents, Drugs
By KEITH J. WINSTEIN
March 6, 2007; Page A12
A congressional committee is looking into the "off label" use of drugs and heart stents, examining the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration.
Boston Scientific Corp. and Johnson & Johnson's Cordis unit, the only makers of drug-coated stents sold in the U.S., were asked to submit marketing materials and clinical data to the House Committee on Oversight and Government Reform on Wednesday. About 60% of drug-coated stents, which prop open clogged arteries, are used off-label. For example, manufacturers haven't rigorously tested their stents in patients who have had heart attacks, but stents are commonly given to such patients. Doctors are allowed to prescribe stents to off-label patients, but manufacturers can't encourage off-label use.
The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.
Here's the first entry of the spring training season for this :
Congressional Panel to Study
Off-Label Use of Stents, Drugs
By KEITH J. WINSTEIN
March 6, 2007; Page A12
A congressional committee is looking into the "off label" use of drugs and heart stents, examining the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration.
Boston Scientific Corp. and Johnson & Johnson's Cordis unit, the only makers of drug-coated stents sold in the U.S., were asked to submit marketing materials and clinical data to the House Committee on Oversight and Government Reform on Wednesday. About 60% of drug-coated stents, which prop open clogged arteries, are used off-label. For example, manufacturers haven't rigorously tested their stents in patients who have had heart attacks, but stents are commonly given to such patients. Doctors are allowed to prescribe stents to off-label patients, but manufacturers can't encourage off-label use.
The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.
My article in the Washington Times of Monday on how some in Congress want to take a good idea -- follow on biologics -- and turn it into a public health threat just to rake in some more cash for social welfare spending....
Nancy Pelosi has a knack for the ironic. In unveiling what she called her party’s “Innovation Agendaâ€, the Speaker from American Samoa proclaimed: “America (is) the breeding ground for the innovations and inventions that increased our prosperity, enhanced our lives, and protected and advanced our freedoms. That dynamic and virtuous cycle of innovation is what secured our status as world leader, and that status has remained unchallenged – until now. “
Little did we know that the challenge Ms. Pelosi was referring to is the Democrat party itself.
In January, Henry Waxman, touting a Families USA study promised that direct government negotionats with drug companies would save Medicare $190 billion, enough money to pay for every senior’s out of pocket drug costs as well as expanding health insurance for kids and rehab for Britney Spears. The savings disappeared when it became evident they were only achievable if Medicare robbed seniors of access to many lifesaving drugs.
Democrats are still short the money. So they plan to get it by stopping that virtuous cycle of innovation in biotechnology. The Murtha plan for stopping the surge is being peddled as a “support the troops plan.†The Access to Lifesaving Medicines Act offered by Congressman Waxman, Senator Charles Schumer, Senator Clinton and termagant Republican Congresswoman Joanne Emerson, creates generic versions of biotech drugs to free up money for social programs, is shrewdly devised as a consumer protection measure. In the process, Waxman and others weaken drug safety and patent protection standards to enrich the generic drug industry.
Ironically (again) in touting the Innovation Agenda, the Speaker from Samoa proclaimed:
“Essential to our pre-eminence is the protection of intellectual property. Our agenda commits to protecting the intellectual property of American innovators worldwide.â€
Not when it stands in the way of expanding the welfare state. Recently the military dictatorship running Thailand following the advice of anti-intellectual property activists (who care more for shredding corporate patent rights than protecting human rights in Thailand), said it would use its Government Pharmaceutical Organization to make generic copies of the heart drug, Plavix and two HIV drugs Kaletra, and Stocrin.
It has also threatened to seize the patent of 11 new drugs including Lipitor and Gleevec. Thailand claims it needs to make or import generic drugs to treat everyone with every disease. The junta – which has military monitors in every pressroom – received a warm endorsement from Congressman Waxman. All hail the Revolution!
Waxman and other Democrats cloaked their efforts in the concern that giving generic companies the license to produce these drugs will make medicines affordable for all. In fact, in 2002 Thailand’s GPO failed to meet the WHO’s drug quality standards. Worse, the drugs were so shoddy that they caused drug resistance, forcing patients to take a second regimen of drugs that raised overall infection rates and treatment costs. And even then, most of the $3 million worth of drugs are exported. The percentage of infected Thai people receiving treatment is among the lowest in the developing world.
So what if generics don’t really increase access to effective medicines? That’s not the goal. Weaker IP allows the Thai junta to line their pockets with the proceeds made from copycat products they can sell at huge margins, money they can then turn around and spend to reward cronies and buy political support.
Similarly, the so-called Access to Life-Saving Medicine Act – simply asserts it is scientifically safe to both produce generic clones of biotech drugs and switch people from the biotech products they are using to generic versions. Making similar but not exact versions of biotech drugs or vaccines that have the same clinical benefit without all the early clinical work required for an innovator product will be possible in the near future. But the Waxman/Clinton/Schumer bill is based on 40-year-old science. And it demands no the testing of comparison products before or after there are marketed. Worse, it dictates to the FDA that the products must be approved as interchangeable.
Ironically, the same group of legislators who claim the FDA is unable to maintain the safety of existing drugs is pushing this legislation. Indeed, Waxman claims he is “justifiably skeptical of any effort to weaken the standards which assure that our food is safe and our medicines are safe and effective.â€
Out of nowhere and not because someone asked them to, Express Scripts (which manages drug benefits would benefit from cheaper biotech products) did a study estimating the savings from follow on biologics. In what will be news to most biotech firms, tithe ‘study’ assumes many biotech products have already lost patent protection and those most products will immediately lose market share when the rest of the products do. The estimated savings over ten years-- $70 billion – coincidentally add up to the amount required to expand the child’s health insurance program.
I wouldn’t count on it. The FDA approved a comparison human growth hormone product called Omnitrope in 2006 based partially on data from Pfizer’s growth product, Genotropin. But Omnitrope also underwent years of clinical tests. During these tests researchers discovered 60 percent of children developed infections to Omnitrope. The company had to do more studies and adjust its production process before it was approved. Omnitrope was never launched in America. In Europe, it has less than 1 percent of the market.
I don’t think Americans bargained for the Democratic assault on innovation when they took power. The party, (along with mean-spirited Republicans like Ms. Emerson), has become the political vehicle for opposing medical advances against disease. The Access to Lifesaving Medicines Act is the first ironic attack. It won’t be the last.
Nancy Pelosi has a knack for the ironic. In unveiling what she called her party’s “Innovation Agendaâ€, the Speaker from American Samoa proclaimed: “America (is) the breeding ground for the innovations and inventions that increased our prosperity, enhanced our lives, and protected and advanced our freedoms. That dynamic and virtuous cycle of innovation is what secured our status as world leader, and that status has remained unchallenged – until now. “
Little did we know that the challenge Ms. Pelosi was referring to is the Democrat party itself.
In January, Henry Waxman, touting a Families USA study promised that direct government negotionats with drug companies would save Medicare $190 billion, enough money to pay for every senior’s out of pocket drug costs as well as expanding health insurance for kids and rehab for Britney Spears. The savings disappeared when it became evident they were only achievable if Medicare robbed seniors of access to many lifesaving drugs.
Democrats are still short the money. So they plan to get it by stopping that virtuous cycle of innovation in biotechnology. The Murtha plan for stopping the surge is being peddled as a “support the troops plan.†The Access to Lifesaving Medicines Act offered by Congressman Waxman, Senator Charles Schumer, Senator Clinton and termagant Republican Congresswoman Joanne Emerson, creates generic versions of biotech drugs to free up money for social programs, is shrewdly devised as a consumer protection measure. In the process, Waxman and others weaken drug safety and patent protection standards to enrich the generic drug industry.
Ironically (again) in touting the Innovation Agenda, the Speaker from Samoa proclaimed:
“Essential to our pre-eminence is the protection of intellectual property. Our agenda commits to protecting the intellectual property of American innovators worldwide.â€
Not when it stands in the way of expanding the welfare state. Recently the military dictatorship running Thailand following the advice of anti-intellectual property activists (who care more for shredding corporate patent rights than protecting human rights in Thailand), said it would use its Government Pharmaceutical Organization to make generic copies of the heart drug, Plavix and two HIV drugs Kaletra, and Stocrin.
It has also threatened to seize the patent of 11 new drugs including Lipitor and Gleevec. Thailand claims it needs to make or import generic drugs to treat everyone with every disease. The junta – which has military monitors in every pressroom – received a warm endorsement from Congressman Waxman. All hail the Revolution!
Waxman and other Democrats cloaked their efforts in the concern that giving generic companies the license to produce these drugs will make medicines affordable for all. In fact, in 2002 Thailand’s GPO failed to meet the WHO’s drug quality standards. Worse, the drugs were so shoddy that they caused drug resistance, forcing patients to take a second regimen of drugs that raised overall infection rates and treatment costs. And even then, most of the $3 million worth of drugs are exported. The percentage of infected Thai people receiving treatment is among the lowest in the developing world.
So what if generics don’t really increase access to effective medicines? That’s not the goal. Weaker IP allows the Thai junta to line their pockets with the proceeds made from copycat products they can sell at huge margins, money they can then turn around and spend to reward cronies and buy political support.
Similarly, the so-called Access to Life-Saving Medicine Act – simply asserts it is scientifically safe to both produce generic clones of biotech drugs and switch people from the biotech products they are using to generic versions. Making similar but not exact versions of biotech drugs or vaccines that have the same clinical benefit without all the early clinical work required for an innovator product will be possible in the near future. But the Waxman/Clinton/Schumer bill is based on 40-year-old science. And it demands no the testing of comparison products before or after there are marketed. Worse, it dictates to the FDA that the products must be approved as interchangeable.
Ironically, the same group of legislators who claim the FDA is unable to maintain the safety of existing drugs is pushing this legislation. Indeed, Waxman claims he is “justifiably skeptical of any effort to weaken the standards which assure that our food is safe and our medicines are safe and effective.â€
Out of nowhere and not because someone asked them to, Express Scripts (which manages drug benefits would benefit from cheaper biotech products) did a study estimating the savings from follow on biologics. In what will be news to most biotech firms, tithe ‘study’ assumes many biotech products have already lost patent protection and those most products will immediately lose market share when the rest of the products do. The estimated savings over ten years-- $70 billion – coincidentally add up to the amount required to expand the child’s health insurance program.
I wouldn’t count on it. The FDA approved a comparison human growth hormone product called Omnitrope in 2006 based partially on data from Pfizer’s growth product, Genotropin. But Omnitrope also underwent years of clinical tests. During these tests researchers discovered 60 percent of children developed infections to Omnitrope. The company had to do more studies and adjust its production process before it was approved. Omnitrope was never launched in America. In Europe, it has less than 1 percent of the market.
I don’t think Americans bargained for the Democratic assault on innovation when they took power. The party, (along with mean-spirited Republicans like Ms. Emerson), has become the political vehicle for opposing medical advances against disease. The Access to Lifesaving Medicines Act is the first ironic attack. It won’t be the last.
From today's edition of The Wall Street Journal ...
Prescription for Trouble
By Scott Gottlieb
Inside the federal agencies that oversee parts of the health-care system, there is a palpable view that doctors can no longer be trusted to do the right thing.
The Food and Drug Administration, Medicare and even the Justice Department all believe they cannot rely on many doctors to heed safety warnings, wisely weigh new medical information, or follow treatment approaches that maximize health benefits or lower costs. So in recent years, these agencies have hatched rules that dictate when treatments should be delivered and even how they can be administered -- especially when it comes to new drugs.
The result is increasing federal regulation of medical practice that constrains health-care providers and limits the choices patients have. It might get worse. New legislation offered by Sens. Edward Kennedy (D., Mass.,) and Michael Enzi (R., Wyo.,), intended to make drugs safer, would raise this regulatory burden by reducing a physician's discretion to exercise clinical judgment and erecting barriers that will exacerbate disparities in access to care.
The legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it, through risk-management plans that would accompany the approval of many new drugs. These "RiskMAPs," as they are called inside the FDA, already guide the use of about 30 marketed drugs as part of "voluntary" arrangements with drug companies.
Right now, pharmaceutical companies propose the plans to better balance the risks and benefits of their drugs, in order to secure FDA approval. But these plans impose burdens, especially on patients who already face difficulty obtaining the specialist care that many RiskMAPs require for the dispensing of new drugs. Thus the FDA and the pharmaceutical industry have mostly confined RiskMAPs to drugs with unpredictable and potentially deadly risks, such as anaphylaxis or rapid organ failure.
That sense of restraint is lifting. New proposals by Congress and the Institute of Medicine advocate RiskMAPs for mitigating a wider set of less-serious problems and to constrain the off-label prescribing of new drugs, even though such prescribing is the standard of care for many diseases. The proposals are gaining traction. Once the FDA is granted the authority to simply impose these RiskMAPs on drug companies, there will be a lot of political pressure on the agency to constrain prescription writing in the name of drug safety.
What would this mean? Consider the RiskMAP recently imposed by the FDA on the use of the diabetes drug Symlin. The new medicine can help very serious diabetics control swings in blood sugar and is one of the few drugs that promote weight loss. But Symlin has a narrow therapeutic margin and can sometimes cause dangerously low blood sugar. The FDA did not trust ordinary generalist doctors -- who treat most diabetics, especially poor or rural patients -- to properly prescribe the medicine or to limit its use to the labeled indication. So Symlin's RiskMAP tries to keep the drug out of generalist hands by, among other things, limiting promotion to doctors specializing in diabetes and who are also supported by certified diabetes educators.
Reflecting this pervasive mistrust of medical practitioners, Medicare is increasingly tying payments to the choices doctors make, compensating doctors more to follow certain cookie-cutter treatments or practice guidelines that are promoted by the agency because they are believed by government experts to maximize benefits or reduce health-care costs.
The Drug Enforcement Administration is also intruding into medical practice. Waging a campaign to cut down on prescription-drug abuse, the DEA has sought legislative authority that would give it a role in limiting the approvals of new pain products -- even though the agency has no ability to appreciate the public health considerations that create a medical need for better drugs to treat serious pain.
Meanwhile, the Department of Justice's war on off-label promotion by drug companies ends up criminalizing the exchange of truthful, non-misleading medical information with doctors on new uses for medicines. This even includes information derived from studies funded by other arms of the government such as the National Institutes of Health. Such was the case in the litigation DOJ recently waged and won against information exchanged on promising new anti-cancer uses for the osteoporosis drug Evista -- some of those uses are now standard care.
All of these approaches harm patients because they impose one-size prescriptions in an area of science that is marked by variation. Furthermore, parameters on the prescription of new drugs, like those imposed on the use of Symlin, create obstacles for patients who already face significant problems getting access to the latest drugs or the specialists who are ordained by FDA's RiskMAPs to prescribe them.
Medicare's treatment guidelines are not the right answer for everyone, because there is a need for judgment in medicine that attunes treatments to individual variations and preferences. DOJ's restrictions on the exchange of medical information deny doctors updated data on the most cutting-edge and specialized uses of new treatments.
Ultimately, we need a better system for accumulating new information about the risks and benefits of treatments, and for communicating this information to providers and patients so people can make more informed choices. The key to improvement is not direct regulation of patient care, but better tools and approaches for evaluating the pros and cons of the many choices patients confront.
Doctors share some blame for inviting this kind of regulation. Agencies have plenty of data showing that some doctors do not heed safety warnings or follow sound advice. Professional societies like the American Medical Association, the various medical journals, and even licensing boards have grown self-interested and have failed the first tenet of an autonomous profession: the ability to regulate itself.
The solutions to any of the health-care problems that government is trying to mitigate will not rest in Washington's constraining "fixes," but with these organs of medicine working with agencies to promote practice standards and safety measures that do not sacrifice medical autonomy and patient choice.
Dr. Gottlieb, who was deputy commissioner of the FDA from 2005 to 2007, is a resident fellow at the American Enterprise Institute.
Prescription for Trouble
By Scott Gottlieb
Inside the federal agencies that oversee parts of the health-care system, there is a palpable view that doctors can no longer be trusted to do the right thing.
The Food and Drug Administration, Medicare and even the Justice Department all believe they cannot rely on many doctors to heed safety warnings, wisely weigh new medical information, or follow treatment approaches that maximize health benefits or lower costs. So in recent years, these agencies have hatched rules that dictate when treatments should be delivered and even how they can be administered -- especially when it comes to new drugs.
The result is increasing federal regulation of medical practice that constrains health-care providers and limits the choices patients have. It might get worse. New legislation offered by Sens. Edward Kennedy (D., Mass.,) and Michael Enzi (R., Wyo.,), intended to make drugs safer, would raise this regulatory burden by reducing a physician's discretion to exercise clinical judgment and erecting barriers that will exacerbate disparities in access to care.
The legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it, through risk-management plans that would accompany the approval of many new drugs. These "RiskMAPs," as they are called inside the FDA, already guide the use of about 30 marketed drugs as part of "voluntary" arrangements with drug companies.
Right now, pharmaceutical companies propose the plans to better balance the risks and benefits of their drugs, in order to secure FDA approval. But these plans impose burdens, especially on patients who already face difficulty obtaining the specialist care that many RiskMAPs require for the dispensing of new drugs. Thus the FDA and the pharmaceutical industry have mostly confined RiskMAPs to drugs with unpredictable and potentially deadly risks, such as anaphylaxis or rapid organ failure.
That sense of restraint is lifting. New proposals by Congress and the Institute of Medicine advocate RiskMAPs for mitigating a wider set of less-serious problems and to constrain the off-label prescribing of new drugs, even though such prescribing is the standard of care for many diseases. The proposals are gaining traction. Once the FDA is granted the authority to simply impose these RiskMAPs on drug companies, there will be a lot of political pressure on the agency to constrain prescription writing in the name of drug safety.
What would this mean? Consider the RiskMAP recently imposed by the FDA on the use of the diabetes drug Symlin. The new medicine can help very serious diabetics control swings in blood sugar and is one of the few drugs that promote weight loss. But Symlin has a narrow therapeutic margin and can sometimes cause dangerously low blood sugar. The FDA did not trust ordinary generalist doctors -- who treat most diabetics, especially poor or rural patients -- to properly prescribe the medicine or to limit its use to the labeled indication. So Symlin's RiskMAP tries to keep the drug out of generalist hands by, among other things, limiting promotion to doctors specializing in diabetes and who are also supported by certified diabetes educators.
Reflecting this pervasive mistrust of medical practitioners, Medicare is increasingly tying payments to the choices doctors make, compensating doctors more to follow certain cookie-cutter treatments or practice guidelines that are promoted by the agency because they are believed by government experts to maximize benefits or reduce health-care costs.
The Drug Enforcement Administration is also intruding into medical practice. Waging a campaign to cut down on prescription-drug abuse, the DEA has sought legislative authority that would give it a role in limiting the approvals of new pain products -- even though the agency has no ability to appreciate the public health considerations that create a medical need for better drugs to treat serious pain.
Meanwhile, the Department of Justice's war on off-label promotion by drug companies ends up criminalizing the exchange of truthful, non-misleading medical information with doctors on new uses for medicines. This even includes information derived from studies funded by other arms of the government such as the National Institutes of Health. Such was the case in the litigation DOJ recently waged and won against information exchanged on promising new anti-cancer uses for the osteoporosis drug Evista -- some of those uses are now standard care.
All of these approaches harm patients because they impose one-size prescriptions in an area of science that is marked by variation. Furthermore, parameters on the prescription of new drugs, like those imposed on the use of Symlin, create obstacles for patients who already face significant problems getting access to the latest drugs or the specialists who are ordained by FDA's RiskMAPs to prescribe them.
Medicare's treatment guidelines are not the right answer for everyone, because there is a need for judgment in medicine that attunes treatments to individual variations and preferences. DOJ's restrictions on the exchange of medical information deny doctors updated data on the most cutting-edge and specialized uses of new treatments.
Ultimately, we need a better system for accumulating new information about the risks and benefits of treatments, and for communicating this information to providers and patients so people can make more informed choices. The key to improvement is not direct regulation of patient care, but better tools and approaches for evaluating the pros and cons of the many choices patients confront.
Doctors share some blame for inviting this kind of regulation. Agencies have plenty of data showing that some doctors do not heed safety warnings or follow sound advice. Professional societies like the American Medical Association, the various medical journals, and even licensing boards have grown self-interested and have failed the first tenet of an autonomous profession: the ability to regulate itself.
The solutions to any of the health-care problems that government is trying to mitigate will not rest in Washington's constraining "fixes," but with these organs of medicine working with agencies to promote practice standards and safety measures that do not sacrifice medical autonomy and patient choice.
Dr. Gottlieb, who was deputy commissioner of the FDA from 2005 to 2007, is a resident fellow at the American Enterprise Institute.
Per my post from yesterday ("Giving EBM the Boot"), our friend John Kamp offers the following:
Why indeed?
As your blog item notes, we better stop "saving" money by restricting formularies and delaying treatment, or there may be fewer lives to save and less money to treat the survivors.
Let me elaborate with one example, Type II diabetes, a condition I follow closely because I have it.
I spent much of the weekend catching up on the new research presented late last year at the World Diabetes Conference in Capetown, South Africia, supporting more aggressive treatment of Type II diabetes.
The research results are exciting. First, earlier and more aggressive treatment will improve blood sugar control and delay the progression of the disease to where becomes ever more difficult to treat and to where complications proliferate. Second, new drugs and new ways to deliver existing drugs provide exciting evolutionary, though not revolutionary, advances. Recently approved and promising new drugs could delay progression of the disease for five to ten years. That could well mean that a 60 year old like me may never go blind, lose a foot, become impotent, require a liver transplant, have a premature heart attack, or face many of the other common complications of this dreaded, deadly disease.
Avoiding these things saves a lot of money in the long run, but requires time, attention and money. Right now -- not a few years from now -- I, my health plan, my doctor and the goverment must focus on more aggressive treatment. That requires pain and money.
For me, it means a significant personal committtment, including:
1. even more aggressive diet and exercise,
2. careful adherence to drug regimines, and
3. giving myself shots of insulin or insulin boosters.
Ouch!
For my doctor, it means education and monitoring much of which is not fully compensated.
Ouch!
For my health care plan and the government, it means spending more money today on treatment and drugs.
Ouch!
For me today's pains are worth the investment. I will work hard with my doctors and my payment partners to keep me healthy and make the investments needed. I will make up any shortfall from the others if needed. I'm fortunate enough to have the means and committment to do so.
Meanwhile, medical policy makers who review this new research must make a similar committment, and lead us to find the means to act on it.
Time is short. We are looking down the barrel of an epidimic of Type II diabetes that may dwarf the personal and social costs of the treatment of things like AIDS and cancer. Unfortunately, denial is the all too common reaction to the social danger of diabetes today.
Right now, medical policy makers must stop denying the cost and trouble of treating Type II diabetes. We must mobilize health care professionals, patients and government, take advantage of existing and developing science, and take a much more aggressive stance.
Denial of treatment at today's pace will mame and kill our bodies and bankrupt our treasuries.
Enough already.
John -- keep those cards and letters coming.
Why indeed?
As your blog item notes, we better stop "saving" money by restricting formularies and delaying treatment, or there may be fewer lives to save and less money to treat the survivors.
Let me elaborate with one example, Type II diabetes, a condition I follow closely because I have it.
I spent much of the weekend catching up on the new research presented late last year at the World Diabetes Conference in Capetown, South Africia, supporting more aggressive treatment of Type II diabetes.
The research results are exciting. First, earlier and more aggressive treatment will improve blood sugar control and delay the progression of the disease to where becomes ever more difficult to treat and to where complications proliferate. Second, new drugs and new ways to deliver existing drugs provide exciting evolutionary, though not revolutionary, advances. Recently approved and promising new drugs could delay progression of the disease for five to ten years. That could well mean that a 60 year old like me may never go blind, lose a foot, become impotent, require a liver transplant, have a premature heart attack, or face many of the other common complications of this dreaded, deadly disease.
Avoiding these things saves a lot of money in the long run, but requires time, attention and money. Right now -- not a few years from now -- I, my health plan, my doctor and the goverment must focus on more aggressive treatment. That requires pain and money.
For me, it means a significant personal committtment, including:
1. even more aggressive diet and exercise,
2. careful adherence to drug regimines, and
3. giving myself shots of insulin or insulin boosters.
Ouch!
For my doctor, it means education and monitoring much of which is not fully compensated.
Ouch!
For my health care plan and the government, it means spending more money today on treatment and drugs.
Ouch!
For me today's pains are worth the investment. I will work hard with my doctors and my payment partners to keep me healthy and make the investments needed. I will make up any shortfall from the others if needed. I'm fortunate enough to have the means and committment to do so.
Meanwhile, medical policy makers who review this new research must make a similar committment, and lead us to find the means to act on it.
Time is short. We are looking down the barrel of an epidimic of Type II diabetes that may dwarf the personal and social costs of the treatment of things like AIDS and cancer. Unfortunately, denial is the all too common reaction to the social danger of diabetes today.
Right now, medical policy makers must stop denying the cost and trouble of treating Type II diabetes. We must mobilize health care professionals, patients and government, take advantage of existing and developing science, and take a much more aggressive stance.
Denial of treatment at today's pace will mame and kill our bodies and bankrupt our treasuries.
Enough already.
John -- keep those cards and letters coming.
According to Anna Wilde Mathews the Breckenridge Institute, a research and consulting firm in Breckenridge, Colo. said that the FDA "bungled" the ".. effort to build a new system for detecting the side effects of medicines after they go on the market, delaying its implementation by at least four years, according to a report commissioned by the agency itself."
But who and what is the Breckenridge Institute?
It is run by Mark Bodnarczuk who has written a book called "Diving In." Here's a description from the Institute's website...
http://www.divingin.com/
Set within the cultural context of Bali and Indonesia, the author uses scuba diving metaphors, interwoven with Jungian psychology and the Enneagram to weave a tapestry of complex characters’ lives and to teach fundamental principles of personal growth. DIVING IN penetrates beyond the superficial and obvious to a deeper analysis of relationships, professional satisfaction, and the ways in which people handle conflict in the workplace.
As for the work of the Institute...it uses Breckenridge Institute’s Harnessing Process™ and Breckenridge Culture Indicator™ (BCI™) to affect deep, sustainable, cultural change.
http://www.breckenridgeinstitute.com/
Here's what's on the Institute's web site....
The coral reef harnesses
the invisible power of
the sun and turns it
into a resource
that gives life to
the sea. Your
organization’s
culture is also an
invisible power -
so why not harness it?
Note to Breckenridge: The FDA just had $10 million cut out of it's IT budget. That's invisible. As we say in New York, harness THAT.
Oh, about Enneagrams...those are the nine points or gateways (some say seven points, linked to seven glands) to personality typing that have existed since the dawn of time. (To boldy go where no Institute has gone before..)
If you really need it, here's info on enneagrams from answers.com.
http://www.answers.com/topic/enneagram
Needless to say, Breckenridge is no McKinsey or Accenture.
Which explains why the FDA asked the institute to stay on, for free, to give them a real action plan instead of a lot of New Age speak about changing culture.
But who and what is the Breckenridge Institute?
It is run by Mark Bodnarczuk who has written a book called "Diving In." Here's a description from the Institute's website...
http://www.divingin.com/
Set within the cultural context of Bali and Indonesia, the author uses scuba diving metaphors, interwoven with Jungian psychology and the Enneagram to weave a tapestry of complex characters’ lives and to teach fundamental principles of personal growth. DIVING IN penetrates beyond the superficial and obvious to a deeper analysis of relationships, professional satisfaction, and the ways in which people handle conflict in the workplace.
As for the work of the Institute...it uses Breckenridge Institute’s Harnessing Process™ and Breckenridge Culture Indicator™ (BCI™) to affect deep, sustainable, cultural change.
http://www.breckenridgeinstitute.com/
Here's what's on the Institute's web site....
The coral reef harnesses
the invisible power of
the sun and turns it
into a resource
that gives life to
the sea. Your
organization’s
culture is also an
invisible power -
so why not harness it?
Note to Breckenridge: The FDA just had $10 million cut out of it's IT budget. That's invisible. As we say in New York, harness THAT.
Oh, about Enneagrams...those are the nine points or gateways (some say seven points, linked to seven glands) to personality typing that have existed since the dawn of time. (To boldy go where no Institute has gone before..)
If you really need it, here's info on enneagrams from answers.com.
http://www.answers.com/topic/enneagram
Needless to say, Breckenridge is no McKinsey or Accenture.
Which explains why the FDA asked the institute to stay on, for free, to give them a real action plan instead of a lot of New Age speak about changing culture.
In the wake of the Grassley Knoll's meltdown over Vioxx (the drug that an FDA advisory committee recommended be returned to market in case anyone noticed) the White House took the $10 million allocated for new FDA IT systems (that would allow the agency to interface with health plans and stop passing the a tin cup to achieve interoperability and develop a common computer code that could be used for spontaneous and real time reporting of drug benefits and risks via electronic health records) was cut and re-allocated to hire additional paper pushers in the agency's Office of Drug Safety.... I have it on good authority that the decision was purely in response to Grassley. So the agency was left scrambling -- during the events described in the WSJ article -- to close a huge gap in its IT budget.
But somehow none of that is relevant. It is easier to piss all over the agency at time when it is under siege and make the hard working people who are seeking to put together a post market IT effort look like idiots. And of course we all know that consultants are the smartest people on the planet...Especially the Breckenridge Institute consultants... But that's the next post..
But somehow none of that is relevant. It is easier to piss all over the agency at time when it is under siege and make the hard working people who are seeking to put together a post market IT effort look like idiots. And of course we all know that consultants are the smartest people on the planet...Especially the Breckenridge Institute consultants... But that's the next post..
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