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My sources tell me that Sunday’s New York Times will feature a front-page feature on FDA preemption by Alex Berenson and Gardiner Harris. And, considering the authors, you know what that means – among other things much use of the “Z†word.
Certainly the piece will be fair and balanced -- as all pieces are in our national newspaper of record -- but whether or not adequate provision will be given to the facts remains to be seen.
To wit, a few pieces of information that may or may not make the final cut of the story.
When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, preemption doesn’t offer them protection and they can and should be held accountable.
The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort†firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
As Dan Troy has written:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.
FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
Amen.
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations – so any mention of “the Bush FDA pushing preemption†is just bad reporting.
Recently, the 3rd U.S. Circuit Court of Appeals ruled that federal law bars a suit alleging false-advertising claims under state law because the U.S. Food and Drug Administration has "exclusive authority" to regulate prescription drug advertising.
"To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress' and the FDA's objectives in protecting the nation's prescription drug users," U.S. Circuit Judge D. Brooks Smith of the Western District of Pennsylvania, wrote in his 51-page opinion in Pennsylvania Employees Benefit Trust Fund, et al. v. Zeneca Inc.
Further, U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted†the law by saying the FDA’s approval of a drug label is only a “first step.†He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.â€
I don’t think it’s a stretch to predict that the Berenson/Harris piece will not be a ringing endorsement for the principle of FDA preemption. And if the Gray Lady follows precedent, there will be a same-day editorial supporting the general view of the article -- that FDA preemption should be struck down as a general principle because of, among other things, the evil pharmaceutical industry and an agency that is “in the pocket†of same.
Who does this help? Consumers? No. Trial lawyers? Yes. (And we all know that Alex Berenson has many of these folks on speed dial – and visa-versa.)
So on Sunday, brew your coffee, toast your bagel – and count how many times trials lawyers are quoted in the article.
Certainly the piece will be fair and balanced -- as all pieces are in our national newspaper of record -- but whether or not adequate provision will be given to the facts remains to be seen.
To wit, a few pieces of information that may or may not make the final cut of the story.
When product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, preemption doesn’t offer them protection and they can and should be held accountable.
The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort†firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.
As Dan Troy has written:
“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.
FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.â€
Amen.
It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations – so any mention of “the Bush FDA pushing preemption†is just bad reporting.
Recently, the 3rd U.S. Circuit Court of Appeals ruled that federal law bars a suit alleging false-advertising claims under state law because the U.S. Food and Drug Administration has "exclusive authority" to regulate prescription drug advertising.
"To allow generalized state consumer fraud laws to dictate the parameters of false and misleading advertising in the prescription drug context would pose an undue obstacle to both Congress' and the FDA's objectives in protecting the nation's prescription drug users," U.S. Circuit Judge D. Brooks Smith of the Western District of Pennsylvania, wrote in his 51-page opinion in Pennsylvania Employees Benefit Trust Fund, et al. v. Zeneca Inc.
Further, U.S. Solicitor General Paul Clement issues an opinion to the U.S. Supreme Court supporting federal preemption, saying that FDA-approved drug labeling preempts state law.
Specifically, Clement disagreed with the Vermont Supreme Court’s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, “erroneously interpreted†the law by saying the FDA’s approval of a drug label is only a “first step.†He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, “If manufacturers were free to make unilateral changes to labeling the day after the FDA’s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agency’s careful balance of risks and benefits thwarted.â€
I don’t think it’s a stretch to predict that the Berenson/Harris piece will not be a ringing endorsement for the principle of FDA preemption. And if the Gray Lady follows precedent, there will be a same-day editorial supporting the general view of the article -- that FDA preemption should be struck down as a general principle because of, among other things, the evil pharmaceutical industry and an agency that is “in the pocket†of same.
Who does this help? Consumers? No. Trial lawyers? Yes. (And we all know that Alex Berenson has many of these folks on speed dial – and visa-versa.)
So on Sunday, brew your coffee, toast your bagel – and count how many times trials lawyers are quoted in the article.
While everyone was posturing around the ENHANCE study another, perhaps more important piece of research was published without any fanfare about treatment of hypertension.
"New data from the Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial were presented today at the American College of Cardiology 2008 Scientific Sessions [1]. They showed that a single-tablet dual-mechanism therapy initiated in high-risk hypertensive patients significantly reduced the risk of morbidity and mortality by 20% compared with conventional therapy.
ACCOMPLISH, a major morbidity and mortality trial, compared the effects of two forms of antihypertensive combination therapies on major fatal and nonfatal cardiovascular events. It was stopped early because treatment with antihypertensive combination therapy — the angiotensin-converting enzyme (ACE) inhibitor benazepril plus the calcium-channel blocker amlodipine — was more effective than treatment with the ACE inhibitor plus diuretic."
As in more effective than a diuretic alone or a diuretic in combo with something else. As in ALLHAT, the foundation for Jerry Avorn's campaign to become FDA commissioner and the so-called gold standard of comparative effectiveness research....
"If you use the combination of a calcium-channel blocker with an ACE inhibitor, you get exquisite blood-pressure control," said Jamerson, who added that similar control was observed with the ACE inhibitor and diuretic. Despite the similar blood pressure, the combination with the calcium-channel blocker and ACE inhibitor reduced cardiovascular morbidity and mortality 20%.
During a press conference announcing the results, Jamerson told the media that the findings are "paradigm-shifting" and the data are a clear win with a clear message. He said the ACCOMPLISH findings challenge the guidelines, especially in terms of starting with a one-drug strategy and the use of diuretics in combination with ACE inhibitors."
This will be an acid test to see just how evidence-based people who are pulling the comparative effectiveness bandwagon really are....Will such studies be rejected if they are not conducted or approved as "kosher" by a Comparative Effectiveness Institute? Will patients have to wait months or years to get access to better or tailored therapies while a bunch of economists sit in judgment?
Science moves way too fast for such an institute to have any real relevance. There are better ways to produce better medical information....A look back without looking ahead means retreating into the past as disease advances...
http://www.medscape.com/viewarticle/572341
"New data from the Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial were presented today at the American College of Cardiology 2008 Scientific Sessions [1]. They showed that a single-tablet dual-mechanism therapy initiated in high-risk hypertensive patients significantly reduced the risk of morbidity and mortality by 20% compared with conventional therapy.
ACCOMPLISH, a major morbidity and mortality trial, compared the effects of two forms of antihypertensive combination therapies on major fatal and nonfatal cardiovascular events. It was stopped early because treatment with antihypertensive combination therapy — the angiotensin-converting enzyme (ACE) inhibitor benazepril plus the calcium-channel blocker amlodipine — was more effective than treatment with the ACE inhibitor plus diuretic."
As in more effective than a diuretic alone or a diuretic in combo with something else. As in ALLHAT, the foundation for Jerry Avorn's campaign to become FDA commissioner and the so-called gold standard of comparative effectiveness research....
"If you use the combination of a calcium-channel blocker with an ACE inhibitor, you get exquisite blood-pressure control," said Jamerson, who added that similar control was observed with the ACE inhibitor and diuretic. Despite the similar blood pressure, the combination with the calcium-channel blocker and ACE inhibitor reduced cardiovascular morbidity and mortality 20%.
During a press conference announcing the results, Jamerson told the media that the findings are "paradigm-shifting" and the data are a clear win with a clear message. He said the ACCOMPLISH findings challenge the guidelines, especially in terms of starting with a one-drug strategy and the use of diuretics in combination with ACE inhibitors."
This will be an acid test to see just how evidence-based people who are pulling the comparative effectiveness bandwagon really are....Will such studies be rejected if they are not conducted or approved as "kosher" by a Comparative Effectiveness Institute? Will patients have to wait months or years to get access to better or tailored therapies while a bunch of economists sit in judgment?
Science moves way too fast for such an institute to have any real relevance. There are better ways to produce better medical information....A look back without looking ahead means retreating into the past as disease advances...
http://www.medscape.com/viewarticle/572341
Here's my review of Melody Petersen's new book, "Our Daily Meds."
http://www.nypost.com/seven/03302008/postopinion/postopbooks/hard_pill_to_swallow_104120.htm?page=0
March 30, 2008 -- Melody Petersen has a drug problem. Not illicit ones, mind you, but prescription drugs. According to her new book "Our Daily Meds," the marketing of medicines has led people to swallow pills that do not work, that they do not really want or need, for diseases that they do not have. The "drug companies chain of influence is so complete that there are few people left to look objectively at the effects of their products on the nation's health or at the consequences of their power for society," she claims.
I don't know what Petersen means by "few" but she counts herself among this vanishing breed of the uninfluenced. Which raises a question - one of many - that Petersen fails to answer: If the chain of influence is "so complete" why is the image of drug companies as marketing machines so firmly etched on the American psyche?
Petersen claims slick marketing drives the sale of expensive and needless meds at the expense of cheaper treatments. Yet over the past three years drug spending has slowed and most new prescriptions are written for generic versions of brand medications.
It goes without saying that the pharmaceutical industry has done dumb and illegal things in an effort to increase sales. Yet Petersen is so intent on ascribing absolute power to drug companies to bamboozle doctors and patients that she never acknowledges the benefits of medicines. She complains that the "$2 billion that Iowans spent on prescriptions filled at pharmacies was approaching the $2.7 billion they spent at all the state's fast-food joints, restaurants and bars." Better liquor than Lipitor according to her.
Petersen asserts that companies focus on ways to "medicate consumers on a daily basis" at the expense of "cheap medicines that actually cure disease." She cites Glaxo's promotion of Zantac, the acid-blocker used to treat ulcers, even as two researchers in Australia were trying to prove that a bacterium, H. pylori, was the underlying cause and therefore could be treated with antibiotics.
What Petersen leaves out is the fact that the bacteria hypothesis was being tested in the late 1980s while Zantac and other drugs like it had been on the market since 1970, well before the infection route was explored. Meanwhile, Zantac was replacing surgery for the treatment of ulcers; a transformation Petersen apparently missed. When it became clear that antibiotics could cure many ulcers, guess who fought for and obtained approval for using such drugs for that purpose? Drug companies of course. And because of aggressive marketing and physician education, today antibiotic therapy is the standard treatment for ulcers.
She quotes Dr. Allen Roses, who helped run drug development at Glaxo, who noted, accurately, that "the vast majority of drugs - more than 90 percent - only work in 30 to 50 percent of the people" as if this were a deliberate act of omission on the part of drug companies. But she fails to quote Roses about his contention that in the future companies will develop personalized medicines that work well for smaller groups of patients based on genetic variations. Most drugs are being rejected by the FDA because they do not work in most people. So why would companies want to persist in that path?
In the same vein, she criticizes companies for "introducing dozens of copycat medicines that were barely distinguishable from one another." Yet, such "me-too" drugs allow the 50 percent of people for whom one medicine won't work to get something that does. So which is it? Are drug companies evil for developing medicines that are not targeted in the first place or evil for marketing many variations of the same medicine to address the hit or miss nature of prescribing?
Petersen's prescription for better health is simple: End the marketing and the need - along with the diseases - will disappear. Childhood depression and suicide? A trumped up myth the screening for which does more harm than good. She quotes a doctor who says: "Kids need to be loved and supported and they'll turn out OK."
Except that in recent years, child suicides have increased as prescribing of antidepressants has declined, reversing a decade of fewer deaths. I'm wondering if Petersen and others who share her view will accept much blame for this tragedy as they have assigned to the big bad drug companies. I doubt it. Self-righteousness is a disease for which there is only one cure: ignoring the source.
Our Daily Meds
How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs
by Melody Petersen
Farrar, Strauss & Giroux
http://www.nypost.com/seven/03302008/postopinion/postopbooks/hard_pill_to_swallow_104120.htm?page=0
March 30, 2008 -- Melody Petersen has a drug problem. Not illicit ones, mind you, but prescription drugs. According to her new book "Our Daily Meds," the marketing of medicines has led people to swallow pills that do not work, that they do not really want or need, for diseases that they do not have. The "drug companies chain of influence is so complete that there are few people left to look objectively at the effects of their products on the nation's health or at the consequences of their power for society," she claims.
I don't know what Petersen means by "few" but she counts herself among this vanishing breed of the uninfluenced. Which raises a question - one of many - that Petersen fails to answer: If the chain of influence is "so complete" why is the image of drug companies as marketing machines so firmly etched on the American psyche?
Petersen claims slick marketing drives the sale of expensive and needless meds at the expense of cheaper treatments. Yet over the past three years drug spending has slowed and most new prescriptions are written for generic versions of brand medications.
It goes without saying that the pharmaceutical industry has done dumb and illegal things in an effort to increase sales. Yet Petersen is so intent on ascribing absolute power to drug companies to bamboozle doctors and patients that she never acknowledges the benefits of medicines. She complains that the "$2 billion that Iowans spent on prescriptions filled at pharmacies was approaching the $2.7 billion they spent at all the state's fast-food joints, restaurants and bars." Better liquor than Lipitor according to her.
Petersen asserts that companies focus on ways to "medicate consumers on a daily basis" at the expense of "cheap medicines that actually cure disease." She cites Glaxo's promotion of Zantac, the acid-blocker used to treat ulcers, even as two researchers in Australia were trying to prove that a bacterium, H. pylori, was the underlying cause and therefore could be treated with antibiotics.
What Petersen leaves out is the fact that the bacteria hypothesis was being tested in the late 1980s while Zantac and other drugs like it had been on the market since 1970, well before the infection route was explored. Meanwhile, Zantac was replacing surgery for the treatment of ulcers; a transformation Petersen apparently missed. When it became clear that antibiotics could cure many ulcers, guess who fought for and obtained approval for using such drugs for that purpose? Drug companies of course. And because of aggressive marketing and physician education, today antibiotic therapy is the standard treatment for ulcers.
She quotes Dr. Allen Roses, who helped run drug development at Glaxo, who noted, accurately, that "the vast majority of drugs - more than 90 percent - only work in 30 to 50 percent of the people" as if this were a deliberate act of omission on the part of drug companies. But she fails to quote Roses about his contention that in the future companies will develop personalized medicines that work well for smaller groups of patients based on genetic variations. Most drugs are being rejected by the FDA because they do not work in most people. So why would companies want to persist in that path?
In the same vein, she criticizes companies for "introducing dozens of copycat medicines that were barely distinguishable from one another." Yet, such "me-too" drugs allow the 50 percent of people for whom one medicine won't work to get something that does. So which is it? Are drug companies evil for developing medicines that are not targeted in the first place or evil for marketing many variations of the same medicine to address the hit or miss nature of prescribing?
Petersen's prescription for better health is simple: End the marketing and the need - along with the diseases - will disappear. Childhood depression and suicide? A trumped up myth the screening for which does more harm than good. She quotes a doctor who says: "Kids need to be loved and supported and they'll turn out OK."
Except that in recent years, child suicides have increased as prescribing of antidepressants has declined, reversing a decade of fewer deaths. I'm wondering if Petersen and others who share her view will accept much blame for this tragedy as they have assigned to the big bad drug companies. I doubt it. Self-righteousness is a disease for which there is only one cure: ignoring the source.
Our Daily Meds
How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs
by Melody Petersen
Farrar, Strauss & Giroux
Grace, that is, as in Grace-Marie Turner, a member of the President's Medicaid Commission and herself President of the Galen Institute.
Yesterday, in front of the House Energy and Commerce Committee's Subcommittee on Health, Grace-Marie presented cogent and important testimony on the Protecting the Medicaid Safety Net Act of 2008 (H.R. 5613).
She made many valid, technically savvy comments and recommendations, but it was her conclusion that should strike at the best bipartisan angels of our legislative nature.
"The president and CEO of the Mayo Clinic, Dr. Denis Cortese, spoke in Washington recently about health reform. Mayo is renowned worldwide for its expertise in medical diagnosis, and Dr. Cortese drew on these capabilities to help policymakers think more strategically about health reform. He said in medical care and in public policy, change must focus on putting the needs of the patient first. Patients want personal, high-value health care, and we need to provide better incentives for programs and providers to provide that care.
Micromanagement of the system through rules and regulations is not putting the patient first. Instead, we need to focus on new financial incentives to encourage patients, providers, program administrators, and the states to make sure they are getting the best value in health spending. Rethinking Medicaid’s financial structure, I believe, is needed.
Our commission heard many, many witnesses testify that patients want a medical home. The worst place to get routine medical care is in a crowded hospital emergency room, but too many Medicaid recipients have no other choice. Having a medical home would mean that someone is working on their behalf to coordinate care. Medicaid doesn’t support the kind of coordination that would lead to better care and more efficient spending.
After hearing hours and hours of testimony during my service on the Medicaid Commission, I believe we must begin the process of transforming this fragmented, procedure-oriented program to one that is focused on coordinated care, results, and outcomes. Quality of care for Medicaid recipients will be improved when health care providers are responding to patients’ needs and not to bureaucratic program rules and regulations.
For Medicaid to become more patient-focused and to more effectively meet the distinctive needs of populations with different needs, Medicaid programs must begin funding health care in a new way. Achieving better quality of care is integrally connected to creating new incentives to achieve better outcomes. This means that new funding mechanisms should be tied to the success of providers and health plans in coordinating patient care, gathering sharable information on the patient’s medical care, and giving patients more information and responsibility to be partners in managing their health.
Focusing on these goals and on putting patients first would assure taxpayers, states, and most importantly, patients, that the system is supporting quality care."
Words well put -- and worth heeding.
Here's a link to Grace-Marie's complete testimony:
Download file
And if you want to consider yourself in the know, my suggestion is this -- read it.
Yesterday, in front of the House Energy and Commerce Committee's Subcommittee on Health, Grace-Marie presented cogent and important testimony on the Protecting the Medicaid Safety Net Act of 2008 (H.R. 5613).
She made many valid, technically savvy comments and recommendations, but it was her conclusion that should strike at the best bipartisan angels of our legislative nature.
"The president and CEO of the Mayo Clinic, Dr. Denis Cortese, spoke in Washington recently about health reform. Mayo is renowned worldwide for its expertise in medical diagnosis, and Dr. Cortese drew on these capabilities to help policymakers think more strategically about health reform. He said in medical care and in public policy, change must focus on putting the needs of the patient first. Patients want personal, high-value health care, and we need to provide better incentives for programs and providers to provide that care.
Micromanagement of the system through rules and regulations is not putting the patient first. Instead, we need to focus on new financial incentives to encourage patients, providers, program administrators, and the states to make sure they are getting the best value in health spending. Rethinking Medicaid’s financial structure, I believe, is needed.
Our commission heard many, many witnesses testify that patients want a medical home. The worst place to get routine medical care is in a crowded hospital emergency room, but too many Medicaid recipients have no other choice. Having a medical home would mean that someone is working on their behalf to coordinate care. Medicaid doesn’t support the kind of coordination that would lead to better care and more efficient spending.
After hearing hours and hours of testimony during my service on the Medicaid Commission, I believe we must begin the process of transforming this fragmented, procedure-oriented program to one that is focused on coordinated care, results, and outcomes. Quality of care for Medicaid recipients will be improved when health care providers are responding to patients’ needs and not to bureaucratic program rules and regulations.
For Medicaid to become more patient-focused and to more effectively meet the distinctive needs of populations with different needs, Medicaid programs must begin funding health care in a new way. Achieving better quality of care is integrally connected to creating new incentives to achieve better outcomes. This means that new funding mechanisms should be tied to the success of providers and health plans in coordinating patient care, gathering sharable information on the patient’s medical care, and giving patients more information and responsibility to be partners in managing their health.
Focusing on these goals and on putting patients first would assure taxpayers, states, and most importantly, patients, that the system is supporting quality care."
Words well put -- and worth heeding.
Here's a link to Grace-Marie's complete testimony:
Download file
And if you want to consider yourself in the know, my suggestion is this -- read it.
Pharmalot blogs on the Consumer's Union report that one out of six people have had a bad enough reaction from a drug that they went to the hospital.
http://www.pharmalot.com/
Which raises the question: are people and doctors taking enough responsibility for how they take their medicines? Another question: are companies doing enough to treat consumers of medicines as customers, resolving problems, addressing side effects on an individualized basis instead of behind a battalion of lawyers..
My guess is the answer is no. Therefore simply dialing up the FDA to complain about one own's sloppy behavior is no way to resolve the issue. A better way would be to get patients with similar meds, conditions and characteristics to report and share information about their experience with all drugs, OTC, prescription, supplements within a virtual community. Then that information can be scrubbed and reviewed for trends and safety signals.
Which is why CMPI is a proud sponsor of http://www.iguard.org the first patient created and patient centered source of information on how drugs are affecting people like you and me.
The Consumers Union recommendation is well intentioned but old school. The way and wave of the future is http://www.iguard.org
http://www.pharmalot.com/
Which raises the question: are people and doctors taking enough responsibility for how they take their medicines? Another question: are companies doing enough to treat consumers of medicines as customers, resolving problems, addressing side effects on an individualized basis instead of behind a battalion of lawyers..
My guess is the answer is no. Therefore simply dialing up the FDA to complain about one own's sloppy behavior is no way to resolve the issue. A better way would be to get patients with similar meds, conditions and characteristics to report and share information about their experience with all drugs, OTC, prescription, supplements within a virtual community. Then that information can be scrubbed and reviewed for trends and safety signals.
Which is why CMPI is a proud sponsor of http://www.iguard.org the first patient created and patient centered source of information on how drugs are affecting people like you and me.
The Consumers Union recommendation is well intentioned but old school. The way and wave of the future is http://www.iguard.org
Peter Huber notes that new medicines replace what Lewis Thomas termed as half-way technology or palliative care and eliminates jobs and buildings along the way..
"Diagnosis used to be almost all doctor; now it's almost all lab--and the lab technicians rely on higher-caliber dipsticks, assays and reagents developed and mass-produced by the same teams of top-tier doctors, research hospitals and big drug companies.
When drugs get good enough, they displace hours of ineffectual (but remunerative) human monitoring and palliative care. Drugs displace doctors, nurses and hospital beds because they really work and because they often work long before bad chemistry morphs into clots, plaques, lumps and other symptoms that require scalpels and beds. In the first half of the 20th century almost all medically supplied gains in health and life expectancy came from germ-killing vaccines and antibiotics. All the important gains since have come from arrays of drugs that target clogged arteries, strokes, cancer and other diseases rooted in our own human chemistry. Human eyes can't see and human hands can't handle most of the things that make us sick--bacteria, viruses, white blood cells, antibodies, proteins, enzymes, fats and genes."
This is a variation of Lewis Thomas wrote over 30 years ago: "A multiplicity of new variants of antibiotics and chemotherapeutic agents has appeared on the market, but one would not expect that the rational use of this technology, even allowing for the high cost of development and marketing, would have proven to be anything like the previous cost of hospital care in the absence of such a technology..typhoid was a 12 to 16 week illness; meningitis often require several months of care through convalesence; these and other common infectious diseases can now be aborted promptly, within just a few days..."
Thomas concludes: If our society wishes to be rid of the diseases, fatal and non-fatal, that plague us the most, there is really little prospect of doing so by mounting a still larger healthcare system at still greater cost for delivering essentially today's kid of technology on a larger scale....The harvest of new information from the biological revolution of the past quarter century is just now coming in, and we can probably begin to figure out the mechanisms of major diseases which were black mysteries a few years back as accurately and profitably as was done for the infectious diseases earlier in the century."
In the 30 years or so since Thomas wrote that, his prediction has come to pass. We still have more to harvest however. And as Huber points out, to think we can do it without commercializing research reflects a hostility to capitalism and protectionism of the worst sort.
Read Full Article
"Diagnosis used to be almost all doctor; now it's almost all lab--and the lab technicians rely on higher-caliber dipsticks, assays and reagents developed and mass-produced by the same teams of top-tier doctors, research hospitals and big drug companies.
When drugs get good enough, they displace hours of ineffectual (but remunerative) human monitoring and palliative care. Drugs displace doctors, nurses and hospital beds because they really work and because they often work long before bad chemistry morphs into clots, plaques, lumps and other symptoms that require scalpels and beds. In the first half of the 20th century almost all medically supplied gains in health and life expectancy came from germ-killing vaccines and antibiotics. All the important gains since have come from arrays of drugs that target clogged arteries, strokes, cancer and other diseases rooted in our own human chemistry. Human eyes can't see and human hands can't handle most of the things that make us sick--bacteria, viruses, white blood cells, antibodies, proteins, enzymes, fats and genes."
This is a variation of Lewis Thomas wrote over 30 years ago: "A multiplicity of new variants of antibiotics and chemotherapeutic agents has appeared on the market, but one would not expect that the rational use of this technology, even allowing for the high cost of development and marketing, would have proven to be anything like the previous cost of hospital care in the absence of such a technology..typhoid was a 12 to 16 week illness; meningitis often require several months of care through convalesence; these and other common infectious diseases can now be aborted promptly, within just a few days..."
Thomas concludes: If our society wishes to be rid of the diseases, fatal and non-fatal, that plague us the most, there is really little prospect of doing so by mounting a still larger healthcare system at still greater cost for delivering essentially today's kid of technology on a larger scale....The harvest of new information from the biological revolution of the past quarter century is just now coming in, and we can probably begin to figure out the mechanisms of major diseases which were black mysteries a few years back as accurately and profitably as was done for the infectious diseases earlier in the century."
In the 30 years or so since Thomas wrote that, his prediction has come to pass. We still have more to harvest however. And as Huber points out, to think we can do it without commercializing research reflects a hostility to capitalism and protectionism of the worst sort.
Read Full Article
Being on a program called "the Infinite Mind" is humbling -- especially when the host is Dr. Fred Goodwin -- and on NPR no less.
Here are the program notes:
In the wake of new high-profile violent acts by people taking anti-depressant medications, including the recent Northern Illinois University shootings, and new research on antidepressant medications and their possible link to "suicidality," we look at the science on the connection between antidepressants and violent behavior.
Is there a link between antidepressants and suicide?
The answer may surprise you.
Joining us are Nada Stotland, president-elect of the American Psychiatric Association; Peter Pitts, a former FDA official who participated in the administration’s labeling of antidepressants as dangerous; and Andrew Leuchter, Director of the Laboratory of Brain, Behavior, and Pharmacology and Senior Research Scientist at UCLA, who has studied how press coverage and public alarm about antidepressants affects the nation’s health and willingness to be treated for real, life threatening illnesses.
And here's a link to the actual program:
http://www.lcmedia.com/mind524.htm
In addition to the program, this link also provides some very good commentary on the topics of depression and SSRIs.
Here are the program notes:
In the wake of new high-profile violent acts by people taking anti-depressant medications, including the recent Northern Illinois University shootings, and new research on antidepressant medications and their possible link to "suicidality," we look at the science on the connection between antidepressants and violent behavior.
Is there a link between antidepressants and suicide?
The answer may surprise you.
Joining us are Nada Stotland, president-elect of the American Psychiatric Association; Peter Pitts, a former FDA official who participated in the administration’s labeling of antidepressants as dangerous; and Andrew Leuchter, Director of the Laboratory of Brain, Behavior, and Pharmacology and Senior Research Scientist at UCLA, who has studied how press coverage and public alarm about antidepressants affects the nation’s health and willingness to be treated for real, life threatening illnesses.
And here's a link to the actual program:
http://www.lcmedia.com/mind524.htm
In addition to the program, this link also provides some very good commentary on the topics of depression and SSRIs.
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.
