Latest Drugwonks' Blog
According to Congressional Quarterly, Chairman Dingell is aggressively pursuing efforts to require the FDA to take a much more aggressive role in monitoring food and drug production and safety abroad, with stiff penalties for companies that import tainted products. The article says: “Dingell’s plan would also crack down on companies that violate drug import regulations. Manufacturers and importers could be fined as much as $500,000 for bringing contaminated or adulterated food or drugs into the country, and individuals could be subject to fines as high as $100,000 for similar offenses.â€
You may ask, How is that statement compatible with legislators’ calls for liberalized prescription drug importation? Good question.
Hopefully Mr. Dingell will point this out when his colleagues raise the subject.
You may ask, How is that statement compatible with legislators’ calls for liberalized prescription drug importation? Good question.
Hopefully Mr. Dingell will point this out when his colleagues raise the subject.
Is Leonard Saltz of Sloan Memorial more interested in attacking drug companies or caring for patients...Rather than pushing insurance companies to cover new cancer drugs, Saltz has devoted time decrying the price of new medications. And now he has taken his ideologically driven campaign to a new low, scaring patients into choosing a treatment based on price. In doing so, Saltz provides an example that even someone with no background in oncology should find shocking and a signal to stay away from Saltz as a treating physician: (From the Pharmamarket Newsletter)
"One example given was for metastatic colon cancer, where the price differential is $60,000 for a treatment course, depending on which of two drugs a patient is prescribed. According to Leonard Saltz of the Memorial Sloan-Kettering Cancer Center, the cheaper generic drug, irinotecan (previously marketed as Campto/Camptosar), causes hair loss. However, he adds that the more expensive agent, Sanofi-Aventis' Eloxatin (oxaliplatin), can cause nerve damage to hands or feet. Depending on one's professional occupation one or the other drug might be easier to accommodate. However, in cases where a patient is concerned about using up savings that might otherwise be left to dependents, the ASCO guidelines are intended to allow for an informed choice with the assistance of a specialist.
Dr Saltz argues that the logical result of such a change in approach must be to have more price transparency, at least so that specialists are able to provide patients with the necessary data."
Where to begin? How about that the two drugs are used in combination in many cases. Or that pharmacogenetics suggests one drug is better than the other. Or clinical trials suggesting longer survival with Eloxatin? Does Lenny Saltz suggest making that information transparent.
Or how about making this information transparent instead of scaring people about prices:
"Since 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drugmakers has approached the problem by matching nearly five million patients with free drugs in cases where there is an inability to pay (Marketletters passim). "
I will talk Saltz seriously when he speaks out strongly against huge cancer drug co-pays, particularly when genetic tests indicate a drug works....Until then, I would avoid him, both as a source of policy advice and cancer care.
"One example given was for metastatic colon cancer, where the price differential is $60,000 for a treatment course, depending on which of two drugs a patient is prescribed. According to Leonard Saltz of the Memorial Sloan-Kettering Cancer Center, the cheaper generic drug, irinotecan (previously marketed as Campto/Camptosar), causes hair loss. However, he adds that the more expensive agent, Sanofi-Aventis' Eloxatin (oxaliplatin), can cause nerve damage to hands or feet. Depending on one's professional occupation one or the other drug might be easier to accommodate. However, in cases where a patient is concerned about using up savings that might otherwise be left to dependents, the ASCO guidelines are intended to allow for an informed choice with the assistance of a specialist.
Dr Saltz argues that the logical result of such a change in approach must be to have more price transparency, at least so that specialists are able to provide patients with the necessary data."
Where to begin? How about that the two drugs are used in combination in many cases. Or that pharmacogenetics suggests one drug is better than the other. Or clinical trials suggesting longer survival with Eloxatin? Does Lenny Saltz suggest making that information transparent.
Or how about making this information transparent instead of scaring people about prices:
"Since 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA) and individual drugmakers has approached the problem by matching nearly five million patients with free drugs in cases where there is an inability to pay (Marketletters passim). "
I will talk Saltz seriously when he speaks out strongly against huge cancer drug co-pays, particularly when genetic tests indicate a drug works....Until then, I would avoid him, both as a source of policy advice and cancer care.
I have great respect for the work of John Wennberg and Elliot Fisher at Dartmouth. Their work has underscored that some clinical practices which are entrenched by tradition or local relationships between doctors and hospitals are not the most effective compared to others. But there is a bit of hubris creeping into their more recent analyses which presume that if we standardized care to cheapest providers of care to those who die within 2 years of a subjectively determined time we could save 20 percent of Medicare spending.
First, as a patient I would like to know which care is associated with not dying within the two year time frame. And as a methodological issue, the failure to compare cost of patients receiving the same care for the same disease without adjusting for severity of illness is a big one. Accordingly, recommending ways to reduce overuse of acute hospital care without knowing what works to improve outcomes -- not always a cut and dried answer -- is probably beyond the data delivered by the Dartmouth group.
http://www.dartmouthatlas.org/
Second, Wennberg and Fisher have also looked at gaps in providing effective care that contributes to longer life. If those gaps were filled it would cost more money. And if people lived longer they would ultimately wind up with a disease that could be expensive to treat. More people receiving better care, more preventive screenings, etc. all adds up. They should be more persistent in coupling that message with their other "magic bullet" solutions.
Finally, to claim that more choices lead to higher costs as an article in the WSJ suggested perhaps mistates what the Dartmouth group concludes. The Dartmouth Atlas suggests that regional variations in utilization have nothing to do with better outcomes. But in fact not even the Dartmouth folks presume to tell everyone what sets of practices would work in all situations. Genomic and clinical insights suggest that tailoring treatments and prevention to individual variations improves outcomes. So how could choice be bad?
http://online.wsj.com/article/SB120752201349093441.html
First, as a patient I would like to know which care is associated with not dying within the two year time frame. And as a methodological issue, the failure to compare cost of patients receiving the same care for the same disease without adjusting for severity of illness is a big one. Accordingly, recommending ways to reduce overuse of acute hospital care without knowing what works to improve outcomes -- not always a cut and dried answer -- is probably beyond the data delivered by the Dartmouth group.
http://www.dartmouthatlas.org/
Second, Wennberg and Fisher have also looked at gaps in providing effective care that contributes to longer life. If those gaps were filled it would cost more money. And if people lived longer they would ultimately wind up with a disease that could be expensive to treat. More people receiving better care, more preventive screenings, etc. all adds up. They should be more persistent in coupling that message with their other "magic bullet" solutions.
Finally, to claim that more choices lead to higher costs as an article in the WSJ suggested perhaps mistates what the Dartmouth group concludes. The Dartmouth Atlas suggests that regional variations in utilization have nothing to do with better outcomes. But in fact not even the Dartmouth folks presume to tell everyone what sets of practices would work in all situations. Genomic and clinical insights suggest that tailoring treatments and prevention to individual variations improves outcomes. So how could choice be bad?
http://online.wsj.com/article/SB120752201349093441.html
I don’t know about you, but I get about 30+ e-mails a day from Jamie Love and his buddies telling me all about the public health benefits of compulsory licensing. If you buy the bunk, then you probably believe in the Easter Bunny. (Apologies to those of you who believe in the Easter Bunny.)
Nowhere has the Love-Line rhetoric been more omnipresent than at the recent session of the WHO’s Intergovernmental Governmental Working Group (IGWG).
Not that it was an even-playing field. The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for innovative medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is questionable and, to their minds, the end justifies the means.
So it comes as no small relief that a comprehensive new study debunks the myth that TRIPS-related pharmaceutical patent protection is somehow contrary to enhancing the health of the developing world. The opposite is true – and truth speaks louder (if not more frequently) than rhetoric.
“Investments in Pharmaceuticals Before and After TRIPS: Property Rights and New Drug Development†(Authors: Margaret Kyle, assistant professor, London Business School and Anita M. McGahan, Professor, Rotman School of Management, University of Toronto) examines the impact of TRIPS on investments in pharmaceutical R&D – with important and significant implications to the ongoing discussions at IGWG, regarding the benefits IP brings to the effort to enhance health in developing and less-developed countries.
Some extracts:
“TRIPS was central in the development of foundational pharmaceutical capabilities in least-developed and developing countries.â€
“TRIPS had a strong, consistent, and major impact on general and corporate investment at every phase of research on global disease.â€
But all is not rosy:
“There appears to be a gap that prevents the immediate efficacy of TRIPS in promoting the introduction of new drugs on poverty diseases.â€
They continue: “On the other hand, TRIPS has encouraged research on disease that are present but not dominant in least-developed and developed countries, such as cardiovascular diseases and cancers.â€
And they conclude by saying, “This research suggests an opportunity to implement policies that are complementary to TRIPS for filling this gap to promote research on poverty diseases immediately.â€
So let's move forward. Let's work together. Let's leave the rhetoric aside.
(And sorry about the Easter Bunny.)
Nowhere has the Love-Line rhetoric been more omnipresent than at the recent session of the WHO’s Intergovernmental Governmental Working Group (IGWG).
Not that it was an even-playing field. The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for innovative medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is questionable and, to their minds, the end justifies the means.
So it comes as no small relief that a comprehensive new study debunks the myth that TRIPS-related pharmaceutical patent protection is somehow contrary to enhancing the health of the developing world. The opposite is true – and truth speaks louder (if not more frequently) than rhetoric.
“Investments in Pharmaceuticals Before and After TRIPS: Property Rights and New Drug Development†(Authors: Margaret Kyle, assistant professor, London Business School and Anita M. McGahan, Professor, Rotman School of Management, University of Toronto) examines the impact of TRIPS on investments in pharmaceutical R&D – with important and significant implications to the ongoing discussions at IGWG, regarding the benefits IP brings to the effort to enhance health in developing and less-developed countries.
Some extracts:
“TRIPS was central in the development of foundational pharmaceutical capabilities in least-developed and developing countries.â€
“TRIPS had a strong, consistent, and major impact on general and corporate investment at every phase of research on global disease.â€
But all is not rosy:
“There appears to be a gap that prevents the immediate efficacy of TRIPS in promoting the introduction of new drugs on poverty diseases.â€
They continue: “On the other hand, TRIPS has encouraged research on disease that are present but not dominant in least-developed and developed countries, such as cardiovascular diseases and cancers.â€
And they conclude by saying, “This research suggests an opportunity to implement policies that are complementary to TRIPS for filling this gap to promote research on poverty diseases immediately.â€
So let's move forward. Let's work together. Let's leave the rhetoric aside.
(And sorry about the Easter Bunny.)
Pleased to report that the LiveSmarter blog has named Drugwonks one of its 100 top Academic/Medical blogs -- and first in our category (Drugs/Medicine).
The full Top 100 list can be found at:
http://www.ondd.org/the-top-100-academic-medical-blogs/
And, as the man says, thank you for your support.
The full Top 100 list can be found at:
http://www.ondd.org/the-top-100-academic-medical-blogs/
And, as the man says, thank you for your support.
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
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.
