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BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
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Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
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DrugWonks Blog
03/27/2007 04:59 PM |
my book review in NY Post Opinion books on Sunday speaks to the need to retain the patient contact, caring, and deep involvement with patients that is at the heart of good medicine.
This essential quality will be the first thing to be further jeopardized if government mandates for expanded coverage don't take "quality of care" into account. Dr. Chen directs these issues to the essential need to care for dying patients, but it is a universal concern for all health care.
http://www.nypost.com/seven/03252007/postopinion/postopbooks/dying_for_compassion_postopbooks_marc_k__siegel.htm Read More & Comment...
This essential quality will be the first thing to be further jeopardized if government mandates for expanded coverage don't take "quality of care" into account. Dr. Chen directs these issues to the essential need to care for dying patients, but it is a universal concern for all health care.
http://www.nypost.com/seven/03252007/postopinion/postopbooks/dying_for_compassion_postopbooks_marc_k__siegel.htm Read More & Comment...
03/27/2007 08:30 AM |
Drugs watchdog faces legal review
The NHS drugs watchdog is to face a judicial review in court for the first time over the guidance it offers.
Two firms have been granted the review over the way the National Institute for Health and Clinical Excellence reached its conclusion on Alzheimer's drugs.
NICE ruled NHS patients with newly diagnosed, mild Alzheimer's disease should not be prescribed the drugs.
Eisai and Pfizer said the process was unfair, but NICE said the claims were without foundation.
NICE guidance in 2001 recommended donepezil, rivastigmine and galantamine - which can make it easier to carry out everyday tasks - should be used as standard.
But in November the watchdog announced people with newly diagnosed, mild Alzheimer's were exempt.
Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.
Neil Hunt, chief executive of the Alzheimer's Society, which will give evidence in the case, said: "Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical.
Why should we care about how the Brits choose care for Alzheimer’s patients Over There? Because their “evidence-based†model is being touted by many Over Here as the right path.
Consider what’s happening Down Under where a similar (although by no means identical) system is also used to limit available treatment for Australians who suffer from Alzheimer’s Disease. The particulars are different – but the message is the same: when government acts to limit therapeutic choices, patients suffer the consequences.
Australia limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.†In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.â€
Restrictive formularies (yes, like the VA system) and health care systems (such as in the United Kingdom, Australia, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down. Read More & Comment...
The NHS drugs watchdog is to face a judicial review in court for the first time over the guidance it offers.
Two firms have been granted the review over the way the National Institute for Health and Clinical Excellence reached its conclusion on Alzheimer's drugs.
NICE ruled NHS patients with newly diagnosed, mild Alzheimer's disease should not be prescribed the drugs.
Eisai and Pfizer said the process was unfair, but NICE said the claims were without foundation.
NICE guidance in 2001 recommended donepezil, rivastigmine and galantamine - which can make it easier to carry out everyday tasks - should be used as standard.
But in November the watchdog announced people with newly diagnosed, mild Alzheimer's were exempt.
Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.
Neil Hunt, chief executive of the Alzheimer's Society, which will give evidence in the case, said: "Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical.
Why should we care about how the Brits choose care for Alzheimer’s patients Over There? Because their “evidence-based†model is being touted by many Over Here as the right path.
Consider what’s happening Down Under where a similar (although by no means identical) system is also used to limit available treatment for Australians who suffer from Alzheimer’s Disease. The particulars are different – but the message is the same: when government acts to limit therapeutic choices, patients suffer the consequences.
Australia limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.†In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.â€
Restrictive formularies (yes, like the VA system) and health care systems (such as in the United Kingdom, Australia, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down. Read More & Comment...
03/27/2007 06:38 AM |
Please join CMPI and Old Dominion University for a robust conversation with Carolyn Clancy, Gail Wilensky, Scott Gottlieb, Stephen Spielberg (no, the one from Dartmouth), Dr. Bob (Goldberg) and distinguished others for a half-day seminar on the role of comparative effectiveness research.
Yes, Senator Baucus was invited.
It's on March 29, from 9am to 2pm at the National Press Club. Full program details can be found at http://www.cmpi.org
To RSVP, please contact Connie Davis, csdavis@odu.com
Hope you can attend. Read More & Comment...
Yes, Senator Baucus was invited.
It's on March 29, from 9am to 2pm at the National Press Club. Full program details can be found at http://www.cmpi.org
To RSVP, please contact Connie Davis, csdavis@odu.com
Hope you can attend. Read More & Comment...
03/26/2007 11:11 PM |
Re-reading the Dorgan-Snowe drug importation legislation in the wake of the laundry list of drugs found in Anna Nicole's blood at time of death leads me to this interesting clause in the bill which takes the definition of the doctor-patient relationship with respect to internet prescribing to Hollywood levels:
(3) QUALIFYING MEDICAL RELATIONSHIP-
`(A) IN GENERAL- With respect to issuing a prescription for a drug for a patient, a practitioner has a qualifying medical relationship with the patient for purposes of this section if--
`(i) at least one in-person medical evaluation of the patient has been conducted by the practitioner; or
`(ii) the practitioner conducts a medical evaluation of the patient as a covering practitioner.
`(B) IN-PERSON MEDICAL EVALUATION- A medical evaluation by a practitioner is an in-person medical evaluation for purposes of this section if the practitioner is in the physical presence of the patient as part of conducting the evaluation, without regard to whether portions of the evaluation are conducted by other health professionals.
`(C) COVERING PRACTITIONER- With respect to a patient, a practitioner is a covering practitioner for purposes of this section if the practitioner conducts a medical evaluation of the patient at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. A practitioner is a covering practitioner without regard to whether the practitioner has conducted any in-person medical evaluation of the patient involved.
And the loophole that will make it easy for any criminal, kiddie-porn site operator or terrorist to set up shop in Canada and source drugs from anywhere:
"An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B)."
Please note that Canada does not vouch for what happens in the scores of export houses up north that import commercial quantities of drugs from Pakistan, Iran, Turkey, etc under a personal use exemption. So all you have to do to comply with the Anna Nicole import bill is be a Rx chop shop in Canada. Read More & Comment...
(3) QUALIFYING MEDICAL RELATIONSHIP-
`(A) IN GENERAL- With respect to issuing a prescription for a drug for a patient, a practitioner has a qualifying medical relationship with the patient for purposes of this section if--
`(i) at least one in-person medical evaluation of the patient has been conducted by the practitioner; or
`(ii) the practitioner conducts a medical evaluation of the patient as a covering practitioner.
`(B) IN-PERSON MEDICAL EVALUATION- A medical evaluation by a practitioner is an in-person medical evaluation for purposes of this section if the practitioner is in the physical presence of the patient as part of conducting the evaluation, without regard to whether portions of the evaluation are conducted by other health professionals.
`(C) COVERING PRACTITIONER- With respect to a patient, a practitioner is a covering practitioner for purposes of this section if the practitioner conducts a medical evaluation of the patient at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. A practitioner is a covering practitioner without regard to whether the practitioner has conducted any in-person medical evaluation of the patient involved.
And the loophole that will make it easy for any criminal, kiddie-porn site operator or terrorist to set up shop in Canada and source drugs from anywhere:
"An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B)."
Please note that Canada does not vouch for what happens in the scores of export houses up north that import commercial quantities of drugs from Pakistan, Iran, Turkey, etc under a personal use exemption. So all you have to do to comply with the Anna Nicole import bill is be a Rx chop shop in Canada. Read More & Comment...
03/26/2007 09:31 AM |
The next time someone who knows nothing about drug development or medicine blathers on about why drug companies don't just focus on breakthrough drugs should read the article in the NEJM about the quest to find a drug that actually reverses atherosclerosis. The statin focused pathway makes a lot of sense and it not dead despite what you will hear because of the complexity that has been discovered in large part because of the huge wager Pfizer made on the torcetrapib molecule.
The "failure" has, as Dr. Nissen and colleagues, article demonstrates, advanced our understanding. I have been a severe critic of Nissen with respect to his pronouncements on the safety of ADHD drugs, but as this article suggests, his handling of the torcetrapib issue has been thoughtful, responsible and in some respects visionary.
http://content.nejm.org/cgi/content/full/NEJMoa070635v1
More needs to be written about this unfolding saga -- as well as other struggles to understand the intimate connection between disease, body, molecule, genetics. It might promote the growth of something lack among those eager to issue pronouncements about how companies should run their businesses: humility. As Derek Lowe of www.corante.com has noted, on a good day scientists walk into a lab not knowing what to expect, The NEJM shows that real money is invested on this proposition every. Read More & Comment...
The "failure" has, as Dr. Nissen and colleagues, article demonstrates, advanced our understanding. I have been a severe critic of Nissen with respect to his pronouncements on the safety of ADHD drugs, but as this article suggests, his handling of the torcetrapib issue has been thoughtful, responsible and in some respects visionary.
http://content.nejm.org/cgi/content/full/NEJMoa070635v1
More needs to be written about this unfolding saga -- as well as other struggles to understand the intimate connection between disease, body, molecule, genetics. It might promote the growth of something lack among those eager to issue pronouncements about how companies should run their businesses: humility. As Derek Lowe of www.corante.com has noted, on a good day scientists walk into a lab not knowing what to expect, The NEJM shows that real money is invested on this proposition every. Read More & Comment...
03/26/2007 07:17 AM |
I keep getting free pedometer offers from AARP. Now I know why. Their usual harangue about rising drug prices has gotten stale. No one is buying it.
AARP launches ad campaign urging drug-price negotiations
Here's the link to the story in USA Today:
http://www.usatoday.com/news/washington/2007-03-25-aarp_N.htm?csp=34
And keep the pedometer! Read More & Comment...
AARP launches ad campaign urging drug-price negotiations
Here's the link to the story in USA Today:
http://www.usatoday.com/news/washington/2007-03-25-aarp_N.htm?csp=34
And keep the pedometer! Read More & Comment...
03/26/2007 06:29 AM |
Okay -- who's in favor of cheaper drugs?
http://www.santacruzsentinel.com/archive/2007/March/25/edit/stories/05edit.htm
Also -- please see Scott Gottlieb's excellent op-ed in today's WSJ:
http://online.wsj.com/article/SB117486373440048427.html?mod=opinion_main_commentaries
Enjoy. Read More & Comment...
http://www.santacruzsentinel.com/archive/2007/March/25/edit/stories/05edit.htm
Also -- please see Scott Gottlieb's excellent op-ed in today's WSJ:
http://online.wsj.com/article/SB117486373440048427.html?mod=opinion_main_commentaries
Enjoy. Read More & Comment...
03/26/2007 06:12 AM |
An excellent commentary from today's edition of the Wall Street Journal ...
Drug Crazy
By RICHARD A. EPSTEIN
In an industry advisory last week, the U.S. Food and Drug Administration announced tough new conflict-of-interest rules against doctors who sit on its advisory committees, which recommend whether the FDA should allow pharmaceutical companies to market their new products. The agency's rationale is that greater transparency is necessary to remove any taint that might undermine the public's confidence in the approval process.
The new rules categorically bar any individual from sitting on any committee to evaluate a drug up for approval when that individual has a financial interest exceeding $50,000. The $50,000 figure includes stock ownership, related research and consulting arrangements. Unfortunately, this measure sweeps too widely by lumping together experts who do clinical trials with those who have a direct economic stake in the success of a drug. The precise measurement of that stake mysteriously turns on the extent that the drug has a "potential for gain or loss" to the committee members or their families. Persons whose financial stakes are less than $50,000 may be allowed to meet with these committees, but not to vote.
The main justification for this new regime is the widespread perception that drug and device makers have "hijacked" the FDA process, allowing dangerous drugs to slip into the market. The most conspicuous illustration involves the various COX-2 inhibitors such as Vioxx and Bextra, when at least 10 members of the FDA advisory panel who voted to leave these drugs on the market had some ties to their respective manufacturers, Merck and Pfizer.
It is here that the difficulties begin. The common perception is that the FDA acted too late in removing these drugs from the marketplace, and indeed should never have approved them at all. That perception rests on a crucial tradeoff: how much of an increased risk of heart attack should people be allowed to run in order to mitigate the ravages of arthritis and other degenerative diseases. One common, but cavalier, notion is that people should learn to cope with pain to stave off the greater potential harm of a heart attack. The evidence on the ground suggests another story.
"Suffering boomers want to fill Vioxx void" is a headline in last Friday's Chicago Tribune. The gist of the story: Baby boomers and others have returned to Pfizer's Celebrex, which reported an 18% increase in sales notwithstanding the FDA's stringent black box warning. Similarly, many individuals stashed away their Vioxx for a rainy day after it was recalled by Merck. These individuals understand the risk they're running, but trust their physicians to minimize its impact.
This evidence should put the FDA's zeal in a new light. Just how do these advisory committees "protect" informed product users by limiting their choices for dealing with crippling chronic conditions?
The FDA's major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval. Nor is the FDA sensitive, as individual physicians surely are, to the simple fact that a drug which cannot be tolerated by one person works wonders in another.
The current get-tough policy on conflicts of interest only magnifies these costly FDA biases. The agency rules cut out the persons who know most about the drugs, and who could well counter unsound objections by critical committee members. But keeping these experts off the committees also skews the deliberative process in a more subtle and powerful way.
Anyone who consults for drug companies is likely to come with the presumption that new drugs may well fill important therapeutic voids. Once these individuals, as a class, are kept off advisory committees, the remaining drug experts are more likely to have the populist views held by the likes of a Marcia Angell or Sidney Wolfe, who suspiciously view most new drugs as insignificant advances over prior treatments. I tremble at the thought that these "untainted" experts will markedly slow down the FDA approval process. This would be bad news for the tens of millions who suffer from arthritis, and the countless individuals who suffer from other conditions. Nor would a the change go unnoticed by drug manufacturers or venture capitalists.
Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don't take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don't need the FDA to slow it up still further. Read More & Comment...
Drug Crazy
By RICHARD A. EPSTEIN
In an industry advisory last week, the U.S. Food and Drug Administration announced tough new conflict-of-interest rules against doctors who sit on its advisory committees, which recommend whether the FDA should allow pharmaceutical companies to market their new products. The agency's rationale is that greater transparency is necessary to remove any taint that might undermine the public's confidence in the approval process.
The new rules categorically bar any individual from sitting on any committee to evaluate a drug up for approval when that individual has a financial interest exceeding $50,000. The $50,000 figure includes stock ownership, related research and consulting arrangements. Unfortunately, this measure sweeps too widely by lumping together experts who do clinical trials with those who have a direct economic stake in the success of a drug. The precise measurement of that stake mysteriously turns on the extent that the drug has a "potential for gain or loss" to the committee members or their families. Persons whose financial stakes are less than $50,000 may be allowed to meet with these committees, but not to vote.
The main justification for this new regime is the widespread perception that drug and device makers have "hijacked" the FDA process, allowing dangerous drugs to slip into the market. The most conspicuous illustration involves the various COX-2 inhibitors such as Vioxx and Bextra, when at least 10 members of the FDA advisory panel who voted to leave these drugs on the market had some ties to their respective manufacturers, Merck and Pfizer.
It is here that the difficulties begin. The common perception is that the FDA acted too late in removing these drugs from the marketplace, and indeed should never have approved them at all. That perception rests on a crucial tradeoff: how much of an increased risk of heart attack should people be allowed to run in order to mitigate the ravages of arthritis and other degenerative diseases. One common, but cavalier, notion is that people should learn to cope with pain to stave off the greater potential harm of a heart attack. The evidence on the ground suggests another story.
"Suffering boomers want to fill Vioxx void" is a headline in last Friday's Chicago Tribune. The gist of the story: Baby boomers and others have returned to Pfizer's Celebrex, which reported an 18% increase in sales notwithstanding the FDA's stringent black box warning. Similarly, many individuals stashed away their Vioxx for a rainy day after it was recalled by Merck. These individuals understand the risk they're running, but trust their physicians to minimize its impact.
This evidence should put the FDA's zeal in a new light. Just how do these advisory committees "protect" informed product users by limiting their choices for dealing with crippling chronic conditions?
The FDA's major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval. Nor is the FDA sensitive, as individual physicians surely are, to the simple fact that a drug which cannot be tolerated by one person works wonders in another.
The current get-tough policy on conflicts of interest only magnifies these costly FDA biases. The agency rules cut out the persons who know most about the drugs, and who could well counter unsound objections by critical committee members. But keeping these experts off the committees also skews the deliberative process in a more subtle and powerful way.
Anyone who consults for drug companies is likely to come with the presumption that new drugs may well fill important therapeutic voids. Once these individuals, as a class, are kept off advisory committees, the remaining drug experts are more likely to have the populist views held by the likes of a Marcia Angell or Sidney Wolfe, who suspiciously view most new drugs as insignificant advances over prior treatments. I tremble at the thought that these "untainted" experts will markedly slow down the FDA approval process. This would be bad news for the tens of millions who suffer from arthritis, and the countless individuals who suffer from other conditions. Nor would a the change go unnoticed by drug manufacturers or venture capitalists.
Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don't take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don't need the FDA to slow it up still further. Read More & Comment...
03/24/2007 08:58 AM |
John Kamp weighs in on the Markey/Waxman bill:
Although I have considerable respect for Congressman Markey, I most of the marketing "improvements," in the new Markey Waxman bill are simply marketing restraints. What an irony that two of the most articulate speakers in the U. S. House of Representatives would use censorship to as a way to help patients learn about the safety aspects of medicine.
Take a careful look at a couple of the restrictions.
1. Clearly an across the board ban on DTC the first three years after a drug's approval would be a violation of the First Amendment. The Supreme Court has never approved censorship as a way to promote an informed population. Even more important, it would be a mistake. What if we have a new drug for bird flu about the time of an outbreak? Wouldn't we want the public to know in every possible way? Similarly, don't we want the public to know about any HPV virus drug that could save the life of hundreds of women? Ignorance is never preferable to education.
2. Mandatory review of the all DTC ads before airing is clearly the kind of "prior restraint" government censorship long banned by English common law and recognized by the Supreme Court as a violation of the First Amendment.
The Coalition for Healthcare Communication salutes companies for taking great care in their ads and following the PhRMA self-regulatory principles. We don't salute Congressmen who would make censorship FDA law. Congress should never force Congressman Markey submit his often pithy remarks to a censor before he is allowed to utter them, nor should Congress silence drug companies until some censor can pass judgment.
It's one thing for a speaker to hold his tongue, it's another for the government to tie it in knots. Read More & Comment...
Although I have considerable respect for Congressman Markey, I most of the marketing "improvements," in the new Markey Waxman bill are simply marketing restraints. What an irony that two of the most articulate speakers in the U. S. House of Representatives would use censorship to as a way to help patients learn about the safety aspects of medicine.
Take a careful look at a couple of the restrictions.
1. Clearly an across the board ban on DTC the first three years after a drug's approval would be a violation of the First Amendment. The Supreme Court has never approved censorship as a way to promote an informed population. Even more important, it would be a mistake. What if we have a new drug for bird flu about the time of an outbreak? Wouldn't we want the public to know in every possible way? Similarly, don't we want the public to know about any HPV virus drug that could save the life of hundreds of women? Ignorance is never preferable to education.
2. Mandatory review of the all DTC ads before airing is clearly the kind of "prior restraint" government censorship long banned by English common law and recognized by the Supreme Court as a violation of the First Amendment.
The Coalition for Healthcare Communication salutes companies for taking great care in their ads and following the PhRMA self-regulatory principles. We don't salute Congressmen who would make censorship FDA law. Congress should never force Congressman Markey submit his often pithy remarks to a censor before he is allowed to utter them, nor should Congress silence drug companies until some censor can pass judgment.
It's one thing for a speaker to hold his tongue, it's another for the government to tie it in knots. Read More & Comment...
03/23/2007 12:36 PM |
Today's New York Times editorial page thinks that the FDA should be 100% funded by legislative appropriations. Here we go again.
First, a correction that you will not see in the Gray Lady:
The Times writes that PDUFA fees “help finance the approval process …â€
True, but not accurate. PDUFA fees finance the review process. A trivial, rhetorical difference? Certainly not.
So what’s the big deal where the money comes from? Two big reasons:
(1) Reality. Does anybody even remotely familiar with the funding history of the FDA really believe that Congress is going to fund the agency at anywhere near appropriate levels? Indeed, if history is any guide, the reverse would occur.
(2) Alacrity. With PDUFA fees come PDUFA dates. Is our short-term memory so bad that we have already forgotten the shameful days of the “drug-lag?†Yes, folks – it was real.
And to add to their revisionist view of pharmaceutical regulation, the New York Times agrees with many of the agency’s critics that, if only the FDA worked harder, they could replace “conflicted†advisory committee members with ones equally talented and more pure.
Malarkey.
Ladies and Gentlemen – mediocrity is not an option.
When legislators try to rewrite history we suffer the inevitable consequences. Read More & Comment...
First, a correction that you will not see in the Gray Lady:
The Times writes that PDUFA fees “help finance the approval process …â€
True, but not accurate. PDUFA fees finance the review process. A trivial, rhetorical difference? Certainly not.
So what’s the big deal where the money comes from? Two big reasons:
(1) Reality. Does anybody even remotely familiar with the funding history of the FDA really believe that Congress is going to fund the agency at anywhere near appropriate levels? Indeed, if history is any guide, the reverse would occur.
(2) Alacrity. With PDUFA fees come PDUFA dates. Is our short-term memory so bad that we have already forgotten the shameful days of the “drug-lag?†Yes, folks – it was real.
And to add to their revisionist view of pharmaceutical regulation, the New York Times agrees with many of the agency’s critics that, if only the FDA worked harder, they could replace “conflicted†advisory committee members with ones equally talented and more pure.
Malarkey.
Ladies and Gentlemen – mediocrity is not an option.
When legislators try to rewrite history we suffer the inevitable consequences. Read More & Comment...
03/22/2007 09:28 PM |
The first post of our new CMPI fellow ... Marc Siegel MD
The spread of Elizabeth Edwards cancer may provoke the public to many reactions: sympathy, empathy, worry. Surely, we all hope that this unfortunate event won't be grounds for either political gain or loss. Surely, we all hope that any public discussion of cancer spread will be grounds for more cancer awareness and prevention and treatment advances.
It was just last week that I wrote an oped in the WSJ about the importance of diagnosing lung cancer before it escapes the lung. I pointed out the need for effective use of technologically advanced CT scanning for this to happen.
I mentioned breast cancer as an example of another cancer where early detection was important for reduced morbidity and lifestyle advantage, if not survival.
Of course breast cancer is generally not as aggressive and is somewhat more responsive to chemotherapy.
But what Mrs. Edwards case points out is just how treacherous the disease is, and just how expensive and emotionally costly treatments for advanced cancer are.
Metastases to the bone, as Mrs. Edwards has sustained, tend to be somewhat amenable to chemotherapy, so that if not a cure, at least this patient can hope for a long term remission and an effective and happy life.
I do not know the details of Edwards' case, or how it was diagnosed. As we all hope for the best outcome for this public figure, I can't help but hope that many other women have their cancer caught as early as possible, whether by mammogram, or breast exam, or by whatever MRI technology becomes more accessible and useful for breast screening. While we hope for the longest life possible for Mrs. Edwards and those like her who suffer from metastatic cancer, we also hope that expensive treatments for metastatic disease can be avoided as frequently as possible as the result of advances in techniques of early detection.
Marc Siegel MD
Dr. Siegel is a prolific writer, an Associate Professor of Medicine and a Fellow in the Master Scholars Society at New York University School of Medicine, a columnist for the Los Angeles Times, a frequent contributor to the Washington Post and Family Circle. He is a member of the board of contributors at USA Today. He appears frequently on CNN, the Fox News Channel, and the NBC Today Show.
Dr. Siegel's "False Alarm: The Truth About the Epidemic of Fear" has been named one of the "Top Science Books of the Year" Read More & Comment...
The spread of Elizabeth Edwards cancer may provoke the public to many reactions: sympathy, empathy, worry. Surely, we all hope that this unfortunate event won't be grounds for either political gain or loss. Surely, we all hope that any public discussion of cancer spread will be grounds for more cancer awareness and prevention and treatment advances.
It was just last week that I wrote an oped in the WSJ about the importance of diagnosing lung cancer before it escapes the lung. I pointed out the need for effective use of technologically advanced CT scanning for this to happen.
I mentioned breast cancer as an example of another cancer where early detection was important for reduced morbidity and lifestyle advantage, if not survival.
Of course breast cancer is generally not as aggressive and is somewhat more responsive to chemotherapy.
But what Mrs. Edwards case points out is just how treacherous the disease is, and just how expensive and emotionally costly treatments for advanced cancer are.
Metastases to the bone, as Mrs. Edwards has sustained, tend to be somewhat amenable to chemotherapy, so that if not a cure, at least this patient can hope for a long term remission and an effective and happy life.
I do not know the details of Edwards' case, or how it was diagnosed. As we all hope for the best outcome for this public figure, I can't help but hope that many other women have their cancer caught as early as possible, whether by mammogram, or breast exam, or by whatever MRI technology becomes more accessible and useful for breast screening. While we hope for the longest life possible for Mrs. Edwards and those like her who suffer from metastatic cancer, we also hope that expensive treatments for metastatic disease can be avoided as frequently as possible as the result of advances in techniques of early detection.
Marc Siegel MD
Dr. Siegel is a prolific writer, an Associate Professor of Medicine and a Fellow in the Master Scholars Society at New York University School of Medicine, a columnist for the Los Angeles Times, a frequent contributor to the Washington Post and Family Circle. He is a member of the board of contributors at USA Today. He appears frequently on CNN, the Fox News Channel, and the NBC Today Show.
Dr. Siegel's "False Alarm: The Truth About the Epidemic of Fear" has been named one of the "Top Science Books of the Year" Read More & Comment...
03/22/2007 03:28 PM |
A taste of the stale debate about Medicare that took -- and will take place -- in Congress. I am so glad I have HBO...
Senator Jon Cornyn sponsored an amendment that would make high income Medicare beneficiaries to pay higher premiums for prescription drugs. It went down in flames.
Not before it got doused by with rhetorical kerosene by Democrat Sen. Sherrod Brown who claimed that Republicans "come to the floor of this chamber ... over and over, from every different direction they attack one of the single greatest programs that this government has ever done."
As opposed to shoving every senior into a VA or Canadian style drug program Senator?
How about enlisting seniors, doctors and others to save Medicare money by not using services and staying healthy? We have taken some steps in that direction but I fear that we are not going to get much traction with Democrats in control... Read More & Comment...
Senator Jon Cornyn sponsored an amendment that would make high income Medicare beneficiaries to pay higher premiums for prescription drugs. It went down in flames.
Not before it got doused by with rhetorical kerosene by Democrat Sen. Sherrod Brown who claimed that Republicans "come to the floor of this chamber ... over and over, from every different direction they attack one of the single greatest programs that this government has ever done."
As opposed to shoving every senior into a VA or Canadian style drug program Senator?
How about enlisting seniors, doctors and others to save Medicare money by not using services and staying healthy? We have taken some steps in that direction but I fear that we are not going to get much traction with Democrats in control... Read More & Comment...
03/22/2007 06:35 AM |
Why is it that only some groups need to be transparent? In many of today's news reports on the FDA's new draft guidance on advisory committee conflict of interest some groups are deemed "consumer advocates" -- but no mention is made of their funding sources, while other organizations are quoted, but tagged "industry funded."
Why is this?
For example:
http://www.baltimoresun.com/news/nationworld/bal-te.fda22mar22,0,763576.story?coll=bal-home-headlines
A good story by a solid reporter -- but shouldn't there be transparency for all concerned?
Isn't that the point? Read More & Comment...
Why is this?
For example:
http://www.baltimoresun.com/news/nationworld/bal-te.fda22mar22,0,763576.story?coll=bal-home-headlines
A good story by a solid reporter -- but shouldn't there be transparency for all concerned?
Isn't that the point? Read More & Comment...
03/21/2007 11:40 AM |
How about a $50K cap for anyone who has taken money a legal expert in a plaintiffs suit or as a consultant thereof or has received a cut from a personal injury or product liability suit. How about anyone who has received large grants from private foundations or government in excess of that amount?
My prediction: just as you saw an exodus of the best and brightest from the NIH as a result of a restrictive and hyper-reactive cap on consulting to crack down on the appearance of the appearance of a conflict, the same will happen with Advi Comms at the FDA. You will get mediocre, unmotivated or ideologically driven researchers populating committees and using the proceedings to promote their particular positions.
http://online.wsj.com/article/SB110980263395968693.html Read More & Comment...
My prediction: just as you saw an exodus of the best and brightest from the NIH as a result of a restrictive and hyper-reactive cap on consulting to crack down on the appearance of the appearance of a conflict, the same will happen with Advi Comms at the FDA. You will get mediocre, unmotivated or ideologically driven researchers populating committees and using the proceedings to promote their particular positions.
http://online.wsj.com/article/SB110980263395968693.html Read More & Comment...
03/21/2007 11:34 AM |
Another smear job on another servant of the public health, Allen Collins, as head of the National Kidney Foundation as part of a INDEPENDENT group of experts developed guidelines to develop EPO levels to a point where people on dialysis lived longer and better lives.
Somehow that never got into the smear job Gardiner Harris did on him...
http://www.nytimes.com/2007/03/21/us/21drug.html?ei=5087%0A&em=&en=1b7a123ccba022cd&ex=1174622400&pagewanted=print
In case anyone is interested in a real contribution to the public health, here a link to the work undertaken by Dr. Collins
http://www.kidney.org/PROFESSIONALS/kdoqi/nkfAdvisory.cfm Read More & Comment...
Somehow that never got into the smear job Gardiner Harris did on him...
http://www.nytimes.com/2007/03/21/us/21drug.html?ei=5087%0A&em=&en=1b7a123ccba022cd&ex=1174622400&pagewanted=print
In case anyone is interested in a real contribution to the public health, here a link to the work undertaken by Dr. Collins
http://www.kidney.org/PROFESSIONALS/kdoqi/nkfAdvisory.cfm Read More & Comment...
03/21/2007 11:32 AM |
Here is the link to the relevant documents:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html
If you are conflicted (either existentially or actually), I grant you a waiver to view these materials. Read More & Comment...
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01591.html
If you are conflicted (either existentially or actually), I grant you a waiver to view these materials. Read More & Comment...
03/21/2007 10:19 AM |
I am currently listening to an FDA stakeholder call on a new draft guidance for FDA advisory committee conflict of interest.
Rather than "in" or "out," the agency is suggesting three options:
(1) If an adcomm member has "some" conflicts, they can sit on the committee and participate in the meeting -- but cannot vote.
The FDA did not define what "some" means.
(2) If an adcomm member receives more than $50,000 compensation from a firm in front of an adcomm, they may not sit on the panal, participate in the debate, or vote.
It isn't clear (at least to me) in what period of time this money can be accrued (i.e., $50,000 in a calendar year, or in 12 months prior to the meeting, etc.).
(3) If a panel member has the "appearance" of a conflict they may be recused.
No definition of what "appearance" means. Perhaps this will be clarified in the actual draft guidance.
More as more develops. Read More & Comment...
Rather than "in" or "out," the agency is suggesting three options:
(1) If an adcomm member has "some" conflicts, they can sit on the committee and participate in the meeting -- but cannot vote.
The FDA did not define what "some" means.
(2) If an adcomm member receives more than $50,000 compensation from a firm in front of an adcomm, they may not sit on the panal, participate in the debate, or vote.
It isn't clear (at least to me) in what period of time this money can be accrued (i.e., $50,000 in a calendar year, or in 12 months prior to the meeting, etc.).
(3) If a panel member has the "appearance" of a conflict they may be recused.
No definition of what "appearance" means. Perhaps this will be clarified in the actual draft guidance.
More as more develops. Read More & Comment...
03/21/2007 10:04 AM |
Want the facts and nothing but the facts on Medicare Advantage?
Of course you do, you're a drugwonk!
Have a look at this document:
Download file
CMPI is glad to have assisted in putting this fact sheet together. Read More & Comment...
Of course you do, you're a drugwonk!
Have a look at this document:
Download file
CMPI is glad to have assisted in putting this fact sheet together. Read More & Comment...
03/21/2007 09:04 AM |
Here's a link to the complete BioCentury feature, "Deconstructing FDAMA."
Download file
Many thanks to Bard Steve and BioCentury for the permission to share. Read More & Comment...
Download file
Many thanks to Bard Steve and BioCentury for the permission to share. Read More & Comment...
03/21/2007 08:11 AM |
Steve Usdin certainly has a way with words. Consider these pearls from the recent edition of BioCentury:
"Part of the lesson from FDAMA is that the road to regulatory perdition is paved with the best legislative intentions.
The fact is the Congress did not accompany its 1997 mandate for new treatments with any risks for FDA's failure to perform, and hasn't followed through with the resources to bring regulatory science into the 21st century.
Lawmakers also lost interest in the outcome, and now have turned their attention to raising political capital by easy grandstanding about safety.
The truth is that neither Vioxx nor anti-depressants, nor Ketek rise to the level of thalidomide. If it were so, then there would be a groundswell of calls to roll back FDAMA's mandate to being new treatments to patients who need them.
But even if there is no return to the pre-1997 era de jure, a de facto rollback is a real possibility unless Congress, regulators, patients and industry again are willing to do the hard work required to build the sophisticated systems to improve the risk-benefit calculus. This revived collaboration is necessary to make palatable the regulatory risk that everyone must accept if the new science is to make its way to the bedside."
We hereby dub Sir Steve the "Bard of BioCentury." Read More & Comment...
"Part of the lesson from FDAMA is that the road to regulatory perdition is paved with the best legislative intentions.
The fact is the Congress did not accompany its 1997 mandate for new treatments with any risks for FDA's failure to perform, and hasn't followed through with the resources to bring regulatory science into the 21st century.
Lawmakers also lost interest in the outcome, and now have turned their attention to raising political capital by easy grandstanding about safety.
The truth is that neither Vioxx nor anti-depressants, nor Ketek rise to the level of thalidomide. If it were so, then there would be a groundswell of calls to roll back FDAMA's mandate to being new treatments to patients who need them.
But even if there is no return to the pre-1997 era de jure, a de facto rollback is a real possibility unless Congress, regulators, patients and industry again are willing to do the hard work required to build the sophisticated systems to improve the risk-benefit calculus. This revived collaboration is necessary to make palatable the regulatory risk that everyone must accept if the new science is to make its way to the bedside."
We hereby dub Sir Steve the "Bard of BioCentury." Read More & Comment...
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