Latest Drugwonks' Blog
Here it is, Kenzi 2.0:
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It's better. But is it reform?
The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.
Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.
The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Institute’s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.
Much like the NIH Foundation, the Institute’s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.
But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.
The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.
The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.
What do we think about Kenzi 2.0? We can do better. We must do better.
And time is running out.
Download file
It's better. But is it reform?
The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.
Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.
The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Institute’s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.
Much like the NIH Foundation, the Institute’s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.
But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.
The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.
The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.
What do we think about Kenzi 2.0? We can do better. We must do better.
And time is running out.
I have Peter's back when it comes to his post on Kenzi. I wrote a piece in the Washington Times supporting the beta version of the bill and I got nothing but flack by everyone for it. I supported the bill in it's nascent form because it understood that safety and efficacy were linked and that Critical Path was, well, critical to making medicines safer as opposed to requiring mindless chain of custody and post market data dredging for every drug.
The current form of the bill - the mutation is a better term -- presumes that the current drug development and evaluation process is just peachy, that are not millions of people dying of cancer, Alzheimer's, infectious disease, stroke and other illnesses because of lack of effective medicines, that we have somehow perfectly translated the insights about disease mechanisms and the genomes into personalized medicines.
Reading the current bill you would think that unsafe medicines are a major public health threat and are becoming even more so because of the way FDA approves and reviews drugs. The facts are that drug withdrawals are the same percentage of drug approvals today as they are now, that user fees are not associated with unsafe drugs and -- most important -- that most adverse events are due to poor prescribing practices and people not taking medicines as instructed.
Kenzi 1.0 and the IOM report put blind faith in administrative and regulatory solutions to make medicines safer, separate and apart from science-based effort to make medcines more effectice and more quickly available to sick and dying patients.
Peter and I hear from individuals all the time who are single parents with months to live who wonder why the FDA is moving faster. My mother spends her retirement caring for my aunt and two friends who have Alzheimer's. Kenzi is a cop-out. As Peter said, is it the opposite of political courage.
And those who complain that we should wait until the NEXT version of Kenzi should remember: we heard that one before and we told the people who depend on the FDA for faster cures the same thing.
As George Bush tried to say: Fool me once, shame on me. You are not going to fool me twice, only surprise me pleasantly.
The current form of the bill - the mutation is a better term -- presumes that the current drug development and evaluation process is just peachy, that are not millions of people dying of cancer, Alzheimer's, infectious disease, stroke and other illnesses because of lack of effective medicines, that we have somehow perfectly translated the insights about disease mechanisms and the genomes into personalized medicines.
Reading the current bill you would think that unsafe medicines are a major public health threat and are becoming even more so because of the way FDA approves and reviews drugs. The facts are that drug withdrawals are the same percentage of drug approvals today as they are now, that user fees are not associated with unsafe drugs and -- most important -- that most adverse events are due to poor prescribing practices and people not taking medicines as instructed.
Kenzi 1.0 and the IOM report put blind faith in administrative and regulatory solutions to make medicines safer, separate and apart from science-based effort to make medcines more effectice and more quickly available to sick and dying patients.
Peter and I hear from individuals all the time who are single parents with months to live who wonder why the FDA is moving faster. My mother spends her retirement caring for my aunt and two friends who have Alzheimer's. Kenzi is a cop-out. As Peter said, is it the opposite of political courage.
And those who complain that we should wait until the NEXT version of Kenzi should remember: we heard that one before and we told the people who depend on the FDA for faster cures the same thing.
As George Bush tried to say: Fool me once, shame on me. You are not going to fool me twice, only surprise me pleasantly.
Alex Berenson, who took a leave of absence from writing fiction at the New York Times to write fiction has himself become a central character in story that I bet Alex himself wish he had written:
Judge Asks N.Y. Times Reporter to Appear
[ Associated Press · 2007-01-30 ]
By SETH SUTEL, AP Business Writer
A New York Times reporter has been asked to appear in federal court next month to answer testimony that a judge said implicated the writer in a "conspiracy" to obtain confidential documents regarding the anti-psychotic drug Zyprexa.
The reporter, Alex Berenson, wrote a number of articles starting late last year saying the drug's manufacturer, Indianapolis-based drug maker Eli Lilly and Co., downplayed Zyprexa's risks and marketed it for unapproved uses. Lilly has denied the charges.
Jack B. Weinstein, a judge in U.S. District Court for the Eastern District of New York, invited Berenson to appear voluntarily in the court on Feb. 7 to explain how he got the documents, which had been sealed by the court. In a filing Tuesday Weinstein said Berenson could be accompanied by his attorney and would be subject to cross-examination."
In the deposition upon which this "invitation" was based it appears that Alex told the so-called 'heroic' James Gottstein, ( a hero to Scientologists and others who believe that drug companies want to hook kids on meds for mental illness) who was suing Lilly and stood to gain millions in the process parties in question that he should subpoena the documents about Zyprexa, which ones to get and when to deliver them in order to insure that the NY Times ran the story first.
Bad enough Jayson Blair made up facts.....
Judge Asks N.Y. Times Reporter to Appear
[ Associated Press · 2007-01-30 ]
By SETH SUTEL, AP Business Writer
A New York Times reporter has been asked to appear in federal court next month to answer testimony that a judge said implicated the writer in a "conspiracy" to obtain confidential documents regarding the anti-psychotic drug Zyprexa.
The reporter, Alex Berenson, wrote a number of articles starting late last year saying the drug's manufacturer, Indianapolis-based drug maker Eli Lilly and Co., downplayed Zyprexa's risks and marketed it for unapproved uses. Lilly has denied the charges.
Jack B. Weinstein, a judge in U.S. District Court for the Eastern District of New York, invited Berenson to appear voluntarily in the court on Feb. 7 to explain how he got the documents, which had been sealed by the court. In a filing Tuesday Weinstein said Berenson could be accompanied by his attorney and would be subject to cross-examination."
In the deposition upon which this "invitation" was based it appears that Alex told the so-called 'heroic' James Gottstein, ( a hero to Scientologists and others who believe that drug companies want to hook kids on meds for mental illness) who was suing Lilly and stood to gain millions in the process parties in question that he should subpoena the documents about Zyprexa, which ones to get and when to deliver them in order to insure that the NY Times ran the story first.
Bad enough Jayson Blair made up facts.....
As we await the new version of the Kennedy/Enzi (nee, Enzi/Kennedy) bill and the debate over its half-brother PDUFA IV, it’s important to reflect on what “victory†looks like.
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ...
Consider REMS. On the face of it, certainly bad, but is it a go-to-the-mat issue? Many say “no.†Drugwonks says “yes.†Yes, because unopposed it allows the train to begin its journey in the wrong direction – and that means permitting momentum that will, in short order, lead to more dangerous policy ideas that will become even more difficult to derail. When it comes to bad ideas, there’s no time like the present to stop them in their tracks.
Consider advisory committee conflict of interest issues. A live-or-die proposition? Many say, “yawn.†Drugwonks says “yikes.†If we allow FDA adcomms to become the realm of the second best and the almost brightest –what have we done to the advancement of America’s health? The answer is, a significant disservice.
Kennedy/Enzi (or the inimitable Dan Troy refers to it, “Kenziâ€) is chockablock with unintended consequences that would significantly set back real FDA reform. Accepting Kenzi as a “least/worst†alternative (especially when the other option is the Dodd/Grassley abomination) represents not savvy political calculation but paralytic cowardice.
Who will step forward with the confidence and the credentials to lead the charge towards a more robust legislative endpoint?
Calling Dr. von Eschenbach ...
I get a kick out of politicians and policymakers who worship at the altar of evidence based medicine without knowing what the hell they are even talking about or even knowing the quality of the evidence. As if by default the information produced by a bunch of government paid contractors who punch up all the 'reliable' studies -- randomized clinical trials -- will come up with an objective answer that can be used to guide every doctor and every payment decision.
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.
Under the Medicare Modernization Act, the Agency for Health Care Quality and Research was required to conduct comparative effectiveness studies of major classes of drugs. They have contracted out to places like RAND and the University of Oregon's Drug Evaluation Deathstar which was created by former Governor Kitzhaber who also came up with the idea of rationing care to Medicaid patients.
Anyways, here are the conclusions of the AHQR's panel comparing second generation antidepressants in treating major depression. I defy anyone to distill any message except: start out with what's cheapest and then switch if there are side effects:
"In general, the various second-generation antidepressants have similar rates of effectiveness. In controlled studies, about 38 percent of patients saw no improvement and 54 percent had only partial improvement.
According to the National Institute of Mental Health's Sequenced Treatment Alternative to Relieve Depression (STAR-D) trial, a substantial number (between about 25 percent and 33 percent) of patients will improve with the addition or substitution of a different drug."
Carol Clancy, who is smart and well intentioned, gave this piece of advice based on these findings:
"As with all medications, second-generation antidepressants should be used after careful consideration of benefits and risks. It's up to clinicians and patients to work closely together so the best possible results are achieved."
And we did the study because....? As Rosanna Danna used to say, "If it's not one thing, it's another."
The AHRQ called for future research to establish reliably the general efficacy of second-generation antidepressants for treating dysthymia and subsyndromal depression. Multiple-arm, head-to-head trials with placebo groups should be used.
Effectiveness studies with a high rate of applicability to primary care populations are generally lacking for most of the drugs. "Effectiveness trials with less stringent eligibility criteria, health outcomes, long study durations and a primary care population would be valuable to determine whether existing differences of second-generation antidepressants are clinically meaningful in 'real world' settings," the AHRQ said. Further research is needed on efficacy in population subgroups, such as the very elderly and patients with common comorbidities.
Recognising that approximately 40% of patients do not respond to initial treatment, the AHRQ said studies should explore whether combinations of antidepressants at initiation of therapy lead to better response rates than single agents.
Large, well-conducted observational studies are also needed to reliably assess the comparative risk of rare but serious adverse events, particularly for very elderly patients.
Hey, why don't we just enroll the entire world in a multiple arm, real world randomized clinical triall alongside a global well-conducted observational study to detect serious adverse events so we can stratify for every subpopulation. By the time we get done collecting and analyzing data - 20 years from now -- there will be a whole new class of targeted therapies based on disease mechanisms which will render the one size fits all approach to medicine will become increasingly outdated.
Of course, we need research on what works. But AHRQ approach and the outlandish proposal to enroll the entire world in eternal clinical trials for specific indications ignores the fact there are better ways to answers the thousands of clinical questions.
We are coming up with one size fits all answers at a time when we are producing personalized medicines. We need medical information that fits the era and its insights.
Follow-on biologics is a matter of when not if. But if it's introduction and explanation is left to the political hacks representing the managed care plans and the generic drug industry, Ben Affleck will have a hit movie many times over before a follow on biotech product is approved.
That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.
But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.
As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?
Download file
That's because in their greed and haste to appease the new Democrat overlords, the political spinmeisters are introducing assumptions about the ease with which one can produce therapeutic analogues and break patents that just don't exist in nature. A look at the good science a company like Momenta Pharmaceuticals is undertaking to improve characterization of complex proteins and their analogues underscores that follow on products are years in the making and will not be the function of just handing over data.
But because the spinmeisters and staff approach the biologicals sciences -- deliberately at times -- with the neuronal sophistication of single cell oceanic life forms -- it looks like producing follow on biologics (and milking money to pay for social programs) should be as easy as tapping a keg at a Moveon.org fundraiser.
As usual, Steve Usdin's Biocentury steers us into reality with his trenchant analysis and factual reporting. Can anyone say gold standard for reporting on pharmaceutical and biotech policy issues?
Download file
In his opening statement today on hearings about political interference with the work of government scientists (climate change) Henry Waxman said: I don't want politically correct science. I want the best science possible.
Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:
“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,†said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.â€
It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....
In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.
Here's one effect of the Waxman peer review process...
Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.
The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process.
Here's Henry Waxman waxing on and off about non-inferiority trials less then four months ago:
“Permitting drug companies to take shortcuts in their clinical trials poses real risks to Americans,†said Rep. Waxman. “An antibiotic that is no better than a placebo can’t fight off an infection. Worse, it can subject you to serious, even life-threatening side effects without any compensating benefit. Americans deserve to have confidence that an FDA-approved drug will be both safe and effective.â€
It's hard to know even where to begin. Non-inferiority trials are not short cuts. And asserting that an antibiotic that is no better than a placebo equals non-inferiority trials is scientifically wrong....
In any event, the fact that a member of Congress (along with Markey and Grassley) asking the GAO to investigate the FDA's use of trial designs is not politically correct science? How is this meddling any different than an OMB review of the methodology of climate change study methodology? It's worse.
Here's one effect of the Waxman peer review process...
Supposedly, FDA reviewers have sent signals that a drug intended to keep people alive whose transplanted organs are being rejected and have six hours to live on average should undergo placebo controlled trials to determine safety.
The best science possible? I would argue that Waxman's micromanagement -- if this FDA anecdote is even has a glint of truth to it -- borders on compromising the canons of science and the integrity of the entire drug evaluation process.
It's called Pharmalot (no relation to Spamalot) but the guy producing it does live about five minutes away from me. He's Ed Silverman, who has covered the drug and biotech industry for the Star-Ledger of New Jersey for over a decade. Ed's reporting has been hard hitting and informative (full disclosure, we have bought each other a cup of Dunkin Donuts cover twice in the past eight years).
Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.
Best of luck, Ed!
Ed will be a panelist at our Media and Medical Science conference by the way and I urge you to check out his new blog which is at http://pharmalot.com/ . We will be linking to it and encourage everyone to become a regular reader.
Best of luck, Ed!
Advertising is really a fancy word for calling attention to yourself, which is what the "authors" of a study -- more of a review of TV commercials -- in that prestigious medical journal the Annals of Family Medicine really is.
The article is entitled "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct to Consumer Advertising." Translation: we Tivo'd a lot episodes of 24, CSI Miami and American Idol as a pretext to make fun of those silly drug ads and get some media attention.
Here's what Dominick Frosch the lead (I am trying not to laugh when I write this ) author of this "study" concluded from his "content analysis":
All of the ads … contained elements that we considered problematic. I think consumers should be more skeptical of the pharmaceutical ads than some surveys find they are."
Ya think Dominick? You mean the fact that jokes about Viagra ads and the warnings about how drugs to certain urinary incontinence in man cause your breasts to swell isn't content analysis enough.
Here's what I consider problematic: Dominick's previous 'scholarship' on the subject of risk communication and what to tell patients who might have a serious disease. Dominick has devoted himself to exploring whether videos or the internet or discussion groups or talking to your doctor are more effective in getting people to stop smoking, get a prostate exam, lose weight, etc. Seems as though there is no clear answer and Dominick never compares advertising of any sort to these other approaches. So how does he know if, as he told Rita Rubin's USA Today: "they leave a lot to be desired in terms of providing useful educational information to consumers."
Maybe they do. But at least the guys in the gym remember the stupid Viagra ads and know what's Viagra's for. And if you want to promote prostate screening would you do it with Dominick Forsch with a video on PBS or Paris Hilton during halftime at the Superbowl.
That's the difference between PSA's (pun intended) and advertising.
The article is entitled "Creating Demand for Prescription Drugs: A Content Analysis of Television Direct to Consumer Advertising." Translation: we Tivo'd a lot episodes of 24, CSI Miami and American Idol as a pretext to make fun of those silly drug ads and get some media attention.
Here's what Dominick Frosch the lead (I am trying not to laugh when I write this ) author of this "study" concluded from his "content analysis":
All of the ads … contained elements that we considered problematic. I think consumers should be more skeptical of the pharmaceutical ads than some surveys find they are."
Ya think Dominick? You mean the fact that jokes about Viagra ads and the warnings about how drugs to certain urinary incontinence in man cause your breasts to swell isn't content analysis enough.
Here's what I consider problematic: Dominick's previous 'scholarship' on the subject of risk communication and what to tell patients who might have a serious disease. Dominick has devoted himself to exploring whether videos or the internet or discussion groups or talking to your doctor are more effective in getting people to stop smoking, get a prostate exam, lose weight, etc. Seems as though there is no clear answer and Dominick never compares advertising of any sort to these other approaches. So how does he know if, as he told Rita Rubin's USA Today: "they leave a lot to be desired in terms of providing useful educational information to consumers."
Maybe they do. But at least the guys in the gym remember the stupid Viagra ads and know what's Viagra's for. And if you want to promote prostate screening would you do it with Dominick Forsch with a video on PBS or Paris Hilton during halftime at the Superbowl.
That's the difference between PSA's (pun intended) and advertising.
Our good friend John Kamp, Executive Director of the Coalition for Healthcare Communication, begs to differ with the recent report in the Annals of Family Medicine on the future of DTC communications. And he takes particular umbrage at a sidebar editorial by Dr. David Kessler.
As do we here at Drugwonks. Kamp's right and his statement deserves to be shared.
We are proud to do so.
Coalition Responds to DTC Study, Editorial In Annals of Family Medicine, January/February 2007
The January/February 2007 edition of the Annals of Family Medicine contains a report on a DTC research study and an accompanying editorial co-authored by former FDA Commissioner David Kessler. Although the FDA needs to ground its DTC policy on the science of consumer behavior, the study and the editorial would lead policy makers in the wrong direction.
Either editorialists Kessler and Levy didn’t read the study carefully or chose to ignore its limits. Nothing in the research supports their opinions and conclusions that more stringent DTC rules are needed. Further, the research authors largely ignore the significant body of studies on the effects of advertising on consumer beliefs and behaviors, including the FDA's own studies, that demonstrate that exposure to advertising leads to more and better doctor-patient conversations.
The full text of the statement can be found by clicking on this link:
Download file
Remember -- it's the First Amendment for a reason.
As do we here at Drugwonks. Kamp's right and his statement deserves to be shared.
We are proud to do so.
Coalition Responds to DTC Study, Editorial In Annals of Family Medicine, January/February 2007
The January/February 2007 edition of the Annals of Family Medicine contains a report on a DTC research study and an accompanying editorial co-authored by former FDA Commissioner David Kessler. Although the FDA needs to ground its DTC policy on the science of consumer behavior, the study and the editorial would lead policy makers in the wrong direction.
Either editorialists Kessler and Levy didn’t read the study carefully or chose to ignore its limits. Nothing in the research supports their opinions and conclusions that more stringent DTC rules are needed. Further, the research authors largely ignore the significant body of studies on the effects of advertising on consumer beliefs and behaviors, including the FDA's own studies, that demonstrate that exposure to advertising leads to more and better doctor-patient conversations.
The full text of the statement can be found by clicking on this link:
Download file
Remember -- it's the First Amendment for a reason.
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.
