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04/16/2007 07:24 AM |
Isn't everyone getting tired of the "Drug company's overhype products with paid for studies" angle? Or better yet, when are people going to do their own thinking on issues instead of letting journalists with an agenda do it for them?
Carreyrou tries to frame the Merck HPV vaccine mandate issue as whether it is efficacious enough to mandate it's use or more to his point, to justify Merck's effort to support mandatory immunization. He brings in statistician's to question whether it will really be effective in a group not included studied in the clinical trials.
The fact is, no vaccine designed to reduce the spread of a virus is 100 percent effective in preventing disease particularly in those with a pre-existing infection. By Carreyrou's standard then vaccines for HIV, syphillis, TB, denge, herpes should not be mandatory or by other means be part of an aggressive effort to immunize 100 percent of patients.
As my colleague Marc Siegel has pointed out time and again, HPV is a sexually transmitted disease that causes precancerous warts that lead to billions of dollars of screenings, surgeries, etc. For that alone Merck's vaccine makes an important contribution. Whether Merck should have pushed for mandatory immunization (which Peter and I support) is another question. Needless to say, anyone can play the guessing game about real world effectiveness but chances are given the mechanistic understanding of the disease as opposed to fantasy baseball analysis that the epidemiologists often take, I would bet on Merck and not a numbers cruncher John dug up.
In any event, the whole article has the sound and feel of an article from a website called corpwatch.com which lays out the case against Merck in the same way Carreyrou does including an interview with the same Maine legislator who criticizes a woman's legislative groups for taking money from Merck.
You can compare the two articles and decide which is more efficacious:
http://www.corpwatch.org/article.php?id=14401
http://online.wsj.com/article/SB117668541991270825.html?mod=hps_us_pageone Read More & Comment...
Carreyrou tries to frame the Merck HPV vaccine mandate issue as whether it is efficacious enough to mandate it's use or more to his point, to justify Merck's effort to support mandatory immunization. He brings in statistician's to question whether it will really be effective in a group not included studied in the clinical trials.
The fact is, no vaccine designed to reduce the spread of a virus is 100 percent effective in preventing disease particularly in those with a pre-existing infection. By Carreyrou's standard then vaccines for HIV, syphillis, TB, denge, herpes should not be mandatory or by other means be part of an aggressive effort to immunize 100 percent of patients.
As my colleague Marc Siegel has pointed out time and again, HPV is a sexually transmitted disease that causes precancerous warts that lead to billions of dollars of screenings, surgeries, etc. For that alone Merck's vaccine makes an important contribution. Whether Merck should have pushed for mandatory immunization (which Peter and I support) is another question. Needless to say, anyone can play the guessing game about real world effectiveness but chances are given the mechanistic understanding of the disease as opposed to fantasy baseball analysis that the epidemiologists often take, I would bet on Merck and not a numbers cruncher John dug up.
In any event, the whole article has the sound and feel of an article from a website called corpwatch.com which lays out the case against Merck in the same way Carreyrou does including an interview with the same Maine legislator who criticizes a woman's legislative groups for taking money from Merck.
You can compare the two articles and decide which is more efficacious:
http://www.corpwatch.org/article.php?id=14401
http://online.wsj.com/article/SB117668541991270825.html?mod=hps_us_pageone Read More & Comment...
04/15/2007 08:26 AM |
Bad Scrabble tiles but good opportunity for a letter to the editor of the Los Angeles Times.
Here's what ran in today's edition:
Price controls on Medicare drugs
Re "Aid for Medicare patients sought," April 11
Although the article states that "Democrats say the government could save money if it used its massive purchasing power to negotiate with pharmaceutical companies," there is little evidence to support their claim.
First, it's not clear that allowing the government to negotiate prices would yield any savings. According to a recent report from the nonpartisan Congressional Budget Office, "Government price negotiation would not yield lower drug prices compared to current law."
Second, Democrats cite the Department of Veterans Affairs' drug benefit as a good model for Medicare Part D. But under the VA model, drug companies must sell their products to the government at a price that is at least 24% less than the non-federal average manufacturer's price. In other words, the VA institutes price controls.
Medicare covers well over 40 million seniors. If price controls are extended to such a large segment of the market, they inevitably would result in reduced consumer choices and stifled drug innovation.
PETER PITTS
Director, Center for Medicine in the Public Interest, New York Read More & Comment...
Here's what ran in today's edition:
Price controls on Medicare drugs
Re "Aid for Medicare patients sought," April 11
Although the article states that "Democrats say the government could save money if it used its massive purchasing power to negotiate with pharmaceutical companies," there is little evidence to support their claim.
First, it's not clear that allowing the government to negotiate prices would yield any savings. According to a recent report from the nonpartisan Congressional Budget Office, "Government price negotiation would not yield lower drug prices compared to current law."
Second, Democrats cite the Department of Veterans Affairs' drug benefit as a good model for Medicare Part D. But under the VA model, drug companies must sell their products to the government at a price that is at least 24% less than the non-federal average manufacturer's price. In other words, the VA institutes price controls.
Medicare covers well over 40 million seniors. If price controls are extended to such a large segment of the market, they inevitably would result in reduced consumer choices and stifled drug innovation.
PETER PITTS
Director, Center for Medicine in the Public Interest, New York Read More & Comment...
04/13/2007 11:04 AM |
The following article is NOT a parody. Someone actually wrote this in a serious vein and not as forced confession while being held hostage by Greenpeace...
Clinical trials are saving lives but may be killing the environment
Drug Researcher.com
UK, 4/13/2007 - Clinical trials are saving lives but may be killing the environment due to their 'intensive energy use' and 'substantial contribution to greenhouse gasses.'
Energy use in clinical research premises and trial-related air travel have been identified as the biggest culprits, in an article published in the March 31 issue of the British Medical Journal.
The situation is only set to intensify as the trend towards outsourcing various elements of clinical trials to far flung destinations all over the world continues to gain momentum.
During a one year audit period of a sample clinical trial, the total emission of greenhouse gasses related to the trial was 126 tonnes of carbon dioxide equivalents (CDEs) - an amount that corresponds to that produced by 32 people in one year on the basis of global per capita estimates, said the researchers.
For the entire five-year duration of the sample trial, about 630 tonnes of CDEs were produced - an amount that is equivalent to 525 round trips flights from London to New York for one passenger, the researchers said.
Specifically, the trial coordination centre accounted for the largest proportion of emissions, generating 50 tonnes (39 per cent), with 45 out of the 50 tonnes coming from electricity usage and the remainder from office waste disposal.
The distribution of drugs and documents was the next biggest contributor, with 35 tonnes (28 per cent) and the majority of this stemmed from the airfreight of treatment packs and documents to hospitals.
This was followed closely by trial-related travel, responsible for 29 tonnes (23 per cent) of emissions, with most coming from air travel, as well as hotel stays for site visits, on-site data verification and meetings.
Furthermore, each individual clinical trial employee was found by the researchers to generate 14 tonnes of CDEs each year, compared with the substantially-lower average of 4-6 tonnes for employees in other service industries.
The research was conducted during August 2003 and July 2004 by the Sustainable Trials Study Group, which was convened by the London School of Hygiene and Tropical Medicine to find ways of reducing greenhouse gas emissions from clinical trials.
For the purpose, a 'carbon audit' was conducted on a multicentre international trial being run by the Medical Research Council (MRC), called CRASH.
The CRASH trial involved 10,008 participants at sites in 49 countries over five years and was investigating the effect of corticosteroids on death and disability in adults with head injury.
The trial was coordinated from London; involved a drug made by Pfizer in the US; a placebo made in France; packaging of both study drugs was done in Wales, from where treatment packs were sent to London for distribution to hospitals around the world.
Commenting on the results, the researchers said: "Clinical trials are energy intensive and produce substantial greenhouse gas emissions."
"Our audit provides insights into how to reduce the carbon intensity of clinical trials."
Suggestions given include using renewable energy sources as well as more efficient energy consumption at clinical trial sites, in addition to reducing the number of staff employed, in order to cut emissions.
Other suggestions posed by the researchers were to simplify trial designs to minimise superfluous data collection, coupled with increasing the use of remote electronic data capture; reduce bureaucracy associated with ethics committee- and-regulatory applications; as well as the increased use of teleconferencing and videoconferencing where possible to slash unnecessary travel.
They also made an interesting parting comment: "Trial results should be made publicly available, as the environmental consequences affect us all." Read More & Comment...
Clinical trials are saving lives but may be killing the environment
Drug Researcher.com
UK, 4/13/2007 - Clinical trials are saving lives but may be killing the environment due to their 'intensive energy use' and 'substantial contribution to greenhouse gasses.'
Energy use in clinical research premises and trial-related air travel have been identified as the biggest culprits, in an article published in the March 31 issue of the British Medical Journal.
The situation is only set to intensify as the trend towards outsourcing various elements of clinical trials to far flung destinations all over the world continues to gain momentum.
During a one year audit period of a sample clinical trial, the total emission of greenhouse gasses related to the trial was 126 tonnes of carbon dioxide equivalents (CDEs) - an amount that corresponds to that produced by 32 people in one year on the basis of global per capita estimates, said the researchers.
For the entire five-year duration of the sample trial, about 630 tonnes of CDEs were produced - an amount that is equivalent to 525 round trips flights from London to New York for one passenger, the researchers said.
Specifically, the trial coordination centre accounted for the largest proportion of emissions, generating 50 tonnes (39 per cent), with 45 out of the 50 tonnes coming from electricity usage and the remainder from office waste disposal.
The distribution of drugs and documents was the next biggest contributor, with 35 tonnes (28 per cent) and the majority of this stemmed from the airfreight of treatment packs and documents to hospitals.
This was followed closely by trial-related travel, responsible for 29 tonnes (23 per cent) of emissions, with most coming from air travel, as well as hotel stays for site visits, on-site data verification and meetings.
Furthermore, each individual clinical trial employee was found by the researchers to generate 14 tonnes of CDEs each year, compared with the substantially-lower average of 4-6 tonnes for employees in other service industries.
The research was conducted during August 2003 and July 2004 by the Sustainable Trials Study Group, which was convened by the London School of Hygiene and Tropical Medicine to find ways of reducing greenhouse gas emissions from clinical trials.
For the purpose, a 'carbon audit' was conducted on a multicentre international trial being run by the Medical Research Council (MRC), called CRASH.
The CRASH trial involved 10,008 participants at sites in 49 countries over five years and was investigating the effect of corticosteroids on death and disability in adults with head injury.
The trial was coordinated from London; involved a drug made by Pfizer in the US; a placebo made in France; packaging of both study drugs was done in Wales, from where treatment packs were sent to London for distribution to hospitals around the world.
Commenting on the results, the researchers said: "Clinical trials are energy intensive and produce substantial greenhouse gas emissions."
"Our audit provides insights into how to reduce the carbon intensity of clinical trials."
Suggestions given include using renewable energy sources as well as more efficient energy consumption at clinical trial sites, in addition to reducing the number of staff employed, in order to cut emissions.
Other suggestions posed by the researchers were to simplify trial designs to minimise superfluous data collection, coupled with increasing the use of remote electronic data capture; reduce bureaucracy associated with ethics committee- and-regulatory applications; as well as the increased use of teleconferencing and videoconferencing where possible to slash unnecessary travel.
They also made an interesting parting comment: "Trial results should be made publicly available, as the environmental consequences affect us all." Read More & Comment...
04/13/2007 10:36 AM |
Make that a Troy ounce.
According to the Wall Street Journal …
“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.â€
A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.
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.â€
“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. Read More & Comment...
According to the Wall Street Journal …
“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.â€
A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.
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.â€
“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. Read More & Comment...
04/13/2007 08:58 AM |
What does the FDA do when a drug is demonstrably safe and efficacious compared to a placebo. It usually approves the drug. In the case of Merck's new COX-2, the AdCom reviewing the drug -- which now includes a lawyer suing Merck -- acknowledged that Arcoxia has the same risk profile as many other painkillers. But the FDA wanted evidence that it met some unmet medical need in a subpopulation.
How about people like me or millions of others who did well on Vioxx or Bextra that have neither?
Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.
According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.
In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.
Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims. Read More & Comment...
How about people like me or millions of others who did well on Vioxx or Bextra that have neither?
Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.
According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.
In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.
Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims. Read More & Comment...
04/13/2007 08:29 AM |
Nevada legislators are once again rolling the dice on patient safety. This time it's not some half-baked and benighted scheme for cheap "Canadian" drugs, but rather an ill-considered plan to build a chinese wall around physician-prescribing data.
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation. Read More & Comment...
Here's the full news story:
http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html
While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor†letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.
Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.
According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.†In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.
The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation. Read More & Comment...
04/13/2007 07:32 AM |
Liberal bloggers on health care who?
The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?
Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).
Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:
* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."
* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.
* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.
Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."
Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.
Here's a link to the complete report:
http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf
And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.
As far as I'm concerned -- the more the better. Read More & Comment...
The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?
Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).
Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:
* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."
* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.
* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.
Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."
Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.
Here's a link to the complete report:
http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf
And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.
As far as I'm concerned -- the more the better. Read More & Comment...
04/12/2007 07:07 AM |
People keep telling me that the only major difference between the "first 100 hours" House bill on the abolition of non-interference and the Senator Baucus' pending piece of legislation is that the the House bill says that the Secretary "shall" and the Baucus bill says that the Secretary "can."
No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.â€
Well said,but there's something else -- comparative effectiveness.
Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.
Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.
How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
Read More & Comment...
No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.â€
Well said,but there's something else -- comparative effectiveness.
Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.
Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.
How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
Read More & Comment...
04/12/2007 04:20 AM |
In 2002, Oxfam International announced a boycott of Israeli goods grown or manufactured in what its literature refers to as the "occupied territories." Last year it blamed Tony Blair for his one sided support of Israel in it's war against Hezbollah. Now of course it supports the Thai dictatorship's effort to seize the IP of drug companies even as they give away free drugs to poor countries.
Just my effort to maintain moral clarity. Read More & Comment...
Just my effort to maintain moral clarity. Read More & Comment...
04/11/2007 02:24 PM |
an interesting study about one of a new wave of vaccines for influenza. I am glad to see the move starting away from egg-based technologies to more genetic technologies. It will enable us to respond to an emerging virus rather than have to anticipate one. I am quoted accurately on this here in the HealthDay piece about it:
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html Read More & Comment...
http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html Read More & Comment...
04/11/2007 12:38 PM |
Catch the last episode of "The Sopranos?" Yeah, the one where Tony and crew go to Canada and discuss how they can make a pile of dough by importing fake/expired Fosamax.
Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.
Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.
Bada Bing!
We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously. Read More & Comment...
Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.
Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.
Bada Bing!
We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously. Read More & Comment...
04/11/2007 12:02 PM |
On April 9th the New York Times editorial page weighed on the issue of subsidized contraception for university students:
“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.â€
“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.â€
“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.â€
“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.â€
Spot the inconsistency?
How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?
This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.
But you can’t have it both ways.
Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.
But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.
(And there isn't.) Read More & Comment...
“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.â€
“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.â€
“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.â€
“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.â€
Spot the inconsistency?
How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?
This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.
But you can’t have it both ways.
Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.
But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.
(And there isn't.) Read More & Comment...
04/11/2007 10:41 AM |
Let's get real -- a system in which a federal PBM "competes" with private-sector PBMs is unworkable and, over time, would result in a dysfunctional government monopoly.
PBMJ = Prescription Benefit Misjudgment.
At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.
At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.
Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.
This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.
Net/Net: a back-door route toward a VA-type pricing system.
Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land. Read More & Comment...
PBMJ = Prescription Benefit Misjudgment.
At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.
At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.
Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.
This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.
Net/Net: a back-door route toward a VA-type pricing system.
Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land. Read More & Comment...
04/11/2007 03:30 AM |
This from Biocentury which I thought was a send up or parody of the extremes to which the FDA would have to go or bottoms of the barrels to which they would have to scrape -- you can choose your image -- in a search for untainted members or at least bias balance rather than just finding the best scientific minds to determine the risks and benefits of a medicine:
Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.
"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.
Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.
The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.
A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.
The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.
According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.
The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."
So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?
We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?
The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys. Read More & Comment...
Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.
"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.
Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.
The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.
A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.
The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.
According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.
The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."
So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?
We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?
The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys. Read More & Comment...
04/10/2007 08:00 PM |
Rule Britainia? Time to change the rule.
From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.
Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS
10th April 2007
Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.
The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.
But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.
Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.
Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."
Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.
NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.
Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.
Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.
"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."
Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.
Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.
A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.
It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.
"The North Staffordshire guideline will be reviewed in the light of its results."
The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate. Read More & Comment...
From today's edition of the London Daily Mail, another example of so-called "evidence-based medicine" focusing on saving costs rather than saving lives.
Cut-price statins linked to increase in patient deaths
By RHODRI PHILLIPS
10th April 2007
Health chiefs are reviewing evidence which apparently shows a link between a cut-price statin and an increased risk of death among heart patients.
The drug, simvastatin, is taken by more than a million people to combat high cholesterol. Doctors were advised in January last year to prescribe it instead of more expensive atorvastatin.
But analysis carried out at University Hospital of North Staffordshire in Stoke-on-Trent shows that three times more patients on the cheaper drug died compared to those taking atorvastatin a year earlier. In the three months from December 2004 to February 2005, five out of 100 patients - or five per cent - prescribed atorvastatin died. But 20 of 121 patients - 17 per cent - on simvastatin died between December 2005 and February 2006.
Now the National Institute for Health and Clinical Excellence (NICE) is reviewing the use of simvastatin.
Dr Giri Rajaratnam, Stoke-on-Trent's public health director said: "NICE are doing a full-scale review of statins, looking at the balance between safety and effectiveness and severity of illness."
Two million people in Britain take statins to lower their cholesterol and help protect against the risk of stroke or heart attack. Since simvastatin was introduced three years ago as a cheaper option, 60 per cent have made the switch.
NICE, which advises NHS trusts on the use of drugs, said a 28-day course of simvastatin given to patients in 40mg doses, costing £3.57, was the equivalent to a 28-day course of 10mg atorvastatin tablets, costing £18.03.
Last year the British Medical Journal predicted the NHS could save £2billion within five years if doctors prescribe the cheaper drug. Simvastatin can be bought over the counter, while atorvastatin is only available on prescription.
Cardiologist Dr Rob Butler, who carried out the research, said: "A decision was taken between the local primary care trusts and the local National Health Service trust to switch to generic simvastatin.
"We decided to audit the effects. We were principally looking for differences in numbers of patients needing to be readmitted following discharge. But we were surprised when we saw such a difference in the death rate."
Dr Butler, who has previously received payment from a number of drugs companies, including Pfizer - which makes atorvastatin under the brand name Lipitor - also noticed more patients returning to hospital for further treatment after using simvastatin.
Dr Rajaratnam has also ordered a review into the statin drugs following Dr Butler's research. However, simvastatin is still being used.
A joint statement issued by the hospital and Stoke-on-Trent Primary Care Trust last week said their policy on statin use was consistent with NICE guidance.
It added: "To determine whether our policy should be amended in light of further evidence, the health economics unit at Birmingham University will consider whether any sub-groups of patients would benefit from intensification of their statin treatment.
"The North Staffordshire guideline will be reviewed in the light of its results."
The NICE advice published in January 2006 advised doctors to prescribe simvastatin as a first resort but to use their judgment if they thought another drug such as atorvastatin was more appropriate. Read More & Comment...
04/10/2007 03:18 PM |
http://www.tnr.com/doc.mhtml?i=w070409&s=cohn041007
According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....
"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "
Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.
Oh.
Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).
Oh.
There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.
Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?
If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.
America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.
Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.
Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.
As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs. Read More & Comment...
According to Jonathan Cohn of The New Republic universal health care ala Europe (note he excludes Canada!) is a great model for America because....
"You don't see their citizens choosing between prescriptions and groceries, or declaring bankruptcy, because of medical bills. "
Well Jon, that's because the European bankruptcy system is based on a debt counseling model while in the US (and Canada) we have an easier path to permit public assumption of private debt. Given Canada's social safety net, in 1997, the incidence of personal bankruptcy was 3 in 1000 there cf to 5 in 1000 in the US.
Oh.
Moreover, according to the Federal Reserve, debt as a percentage of household income is higher in the UK, Japan and Canada than it is in the US (which has the same ratio as Germany and higher than France).
Oh.
There are surveys galore that also claim up to 35 percent of seniors choose between food and home heating bills.
Should we have universal food insurance or universal heating coverage too, with consumption and price levels set by government?
If Cohn and other liberals want to diddle around about whether you can get better care in the US or Europe or Canada or Japan that's fine. The reality is that everyone else waits longer than Americans for all kinds of care, particularly cancer care and low birth weight babies are less likely to receive life sustaining care anywhere else on the planet. We do have gaps and holes in our system of coverage but they are created because of duplication and regulations that protect corporations, insurance companies and unions from market competition.
America has a health system better prepared to deal with an aging society, better positioned to invest in the health of its citizens for long term prosperity and independence, more dedicated to extending and enriching life at both it's beginning and end and poised to achieve in greater gains against infectious diseases and chronic illnesses than any other nation in the history of mankind.
Europe's health care system is tethered to an unsustainable method of financing --a shrinking work force paying higher taxes -- and is propped up in the short term as it's military by an indirect subsidy from America's technological superiority and inventiveness. That too is coming to a quick end as health systems throughout the continent are explicitly and implicitly rationing access to the best and newer medicines.
Cohn and other liberals want us to believe universal health care leads to better health. But the gap in health status between rich and poor, educated and uneducated here and abroad are largely the same.. Health care might be free but if you lead a chaotic and disorganized life or engage in risky behavior or postpone seeking care your chances of survival decline. And time is not free to anyone regardless of income. Ultimately, time has a cost and it exacts a particularly heavy one on the poor and elderly. Countries that ration access to the right treatment at the optimal time through waiting, canceling appointments, gatekeepers etc, step therapy kill their society from within.
As quick PS added April 11... The tool the Euros use to ration? Comparative effectiveness analysis. Which is what the Dems are pushing for in order to push down drug prices and access to new drugs. Read More & Comment...
04/09/2007 03:31 PM |
In an effort to find a counterpoint to industry concerns about follow on biologic legislation (here's goes my chance to land on his speed dial) Robert Pear mis-characterizes Janet Woodcock's clear and unambiguous testimony stating that the FDA had the regulatory authority and know how to develop a pathway for the approval of FOBs. He makes it seem that Woodcock claims you don't need human testing to establish that two biologics are interchangeable.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings. Read More & Comment...
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings. Read More & Comment...
04/06/2007 08:20 AM |
Much chatter about contaminated pet food.
Not surprisingly, media focus is on grieving pet owners rather than on the real issue -- why did it happen and how can it be prevented from happening again.
The answer, more money for the FDA. If you think that FDA is under-funded when it comes to drugs and devices -- check out the abysmally low budgets for CFSAN and CVM.
Penny wise and pound (no pun intended) foolish? Neither. Dangerous. Read More & Comment...
Not surprisingly, media focus is on grieving pet owners rather than on the real issue -- why did it happen and how can it be prevented from happening again.
The answer, more money for the FDA. If you think that FDA is under-funded when it comes to drugs and devices -- check out the abysmally low budgets for CFSAN and CVM.
Penny wise and pound (no pun intended) foolish? Neither. Dangerous. Read More & Comment...
04/05/2007 06:50 PM |
I'm looking forward to the results of the NIH trial, but I don't think there is truly much controversy about the usefulness of this test, esp. in the right hands.
Perhaps politically, smokers aren't the most popular group, and a nicotine-blocking drug like Chantix has been a wonderful addition to my clinical arsenal. Better to be a non-smoker, whereupon the risks drop dramatically. I've written previously - 1-06 - for the Wash Post about how quitting can best be accomplished by a change in lifestyle, and how quitting decreases both short term and long term health risks.
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/02/AR2006010201507.html?nav=rss_health
But for those who haven't quit, and even for those who have, screening at some regular interval has important health benefits.
Here's an interesting study just published - the mention is in Cancer Research UK:
Lung cancer screening effective for high-risk groups, says US group
FRIDAY 30 MARCH 2007
Screening high-risk individuals for lung cancer with an annual 'CT' scan may be able to detect tumours when they are most treatable, according to new US research.
The New York Early Lung Cancer Action Project study, published in the April edition of Radiology, examined the screening results of 6,295 former smokers aged over 60.
A total 124 of these people were diagnosed with lung cancer.
Almost nine in every ten of those diagnosed were found to have tumours that that had not yet spread.
Lung cancer screening is an area of intense interest, as currently most lung cancers are not detected until they are at an advanced stage when the disease is extremely difficult to treat successfully.
The new findings run counter to research published in March in the Journal of the American Medical Association, which suggested that CT screening may not significantly reduce death rates, despite detecting more cancers.
Some scientists think that CT screening may also be detecting slow-growing tumours that would not cause harm, leading people to be treated unnecessarily.
"The JAMA article was the first application of a newly developed computer model which predicted expected deaths from lung cancer, and there are numerous concerns about its validity," said Dr Henschke.
The US National Cancer Institute is funding a large trial, NLST, involving over 50,000 people, with results expected in 2009. This trial should answer questions over the effectiveness of CT screening and chest x-rays in reducing lung cancer deaths. Read More & Comment...
Perhaps politically, smokers aren't the most popular group, and a nicotine-blocking drug like Chantix has been a wonderful addition to my clinical arsenal. Better to be a non-smoker, whereupon the risks drop dramatically. I've written previously - 1-06 - for the Wash Post about how quitting can best be accomplished by a change in lifestyle, and how quitting decreases both short term and long term health risks.
http://www.washingtonpost.com/wp-dyn/content/article/2006/01/02/AR2006010201507.html?nav=rss_health
But for those who haven't quit, and even for those who have, screening at some regular interval has important health benefits.
Here's an interesting study just published - the mention is in Cancer Research UK:
Lung cancer screening effective for high-risk groups, says US group
FRIDAY 30 MARCH 2007
Screening high-risk individuals for lung cancer with an annual 'CT' scan may be able to detect tumours when they are most treatable, according to new US research.
The New York Early Lung Cancer Action Project study, published in the April edition of Radiology, examined the screening results of 6,295 former smokers aged over 60.
A total 124 of these people were diagnosed with lung cancer.
Almost nine in every ten of those diagnosed were found to have tumours that that had not yet spread.
Lung cancer screening is an area of intense interest, as currently most lung cancers are not detected until they are at an advanced stage when the disease is extremely difficult to treat successfully.
The new findings run counter to research published in March in the Journal of the American Medical Association, which suggested that CT screening may not significantly reduce death rates, despite detecting more cancers.
Some scientists think that CT screening may also be detecting slow-growing tumours that would not cause harm, leading people to be treated unnecessarily.
"The JAMA article was the first application of a newly developed computer model which predicted expected deaths from lung cancer, and there are numerous concerns about its validity," said Dr Henschke.
The US National Cancer Institute is funding a large trial, NLST, involving over 50,000 people, with results expected in 2009. This trial should answer questions over the effectiveness of CT screening and chest x-rays in reducing lung cancer deaths. Read More & Comment...
04/05/2007 10:22 AM |
I've just returned from a breakfast (kindly organized by the Government of France) with seven leading French journalists. The topic: health care. Needless to say, it was a wide-ranging conversation. A few items of note:
(1) My French is really rusty.
(2) While the systems in France and the US are very different, we share many of the same problems -- the biggest being government focus on cost rather than care.
(3) We spent a lot of time talking about how to measure the beneft of incremental innovation -- as well as what incremental innovation means and why any conversation on this topic must also include (and to a very large extent) how to expand the use of existing medicines in additional ways. We talked off-label usage.
(4) We talked comparative effectiveness and whether or not current measurements of such are legitimate ways to determine reimbursement decisions. (In other words, we spent a lot of time talking about the inappropriate ways payors -- public and private, HAS and DERP -- use general population RCTs to make "me too"/either-or decisions.
(5) And we talked about patient information. Empowering the consumer? Mon Dieu!
(6) And the fact that patient groups that are government funded are unlikely to be real patient advocates when it comes to therapeutic reimbursement decisions.
(7) And we talked about the importance of prevention programs. (Although I must add that, after the breakfast was over, they all went outside for a smoke.)
But the general theme that drove the entire conversation was, as mentioned above, what happens when cost trumps care and short-term political concerns dwarf long-term consequences.
And, no matter what language you're speaking, it sure sounds familiar. Read More & Comment...
(1) My French is really rusty.
(2) While the systems in France and the US are very different, we share many of the same problems -- the biggest being government focus on cost rather than care.
(3) We spent a lot of time talking about how to measure the beneft of incremental innovation -- as well as what incremental innovation means and why any conversation on this topic must also include (and to a very large extent) how to expand the use of existing medicines in additional ways. We talked off-label usage.
(4) We talked comparative effectiveness and whether or not current measurements of such are legitimate ways to determine reimbursement decisions. (In other words, we spent a lot of time talking about the inappropriate ways payors -- public and private, HAS and DERP -- use general population RCTs to make "me too"/either-or decisions.
(5) And we talked about patient information. Empowering the consumer? Mon Dieu!
(6) And the fact that patient groups that are government funded are unlikely to be real patient advocates when it comes to therapeutic reimbursement decisions.
(7) And we talked about the importance of prevention programs. (Although I must add that, after the breakfast was over, they all went outside for a smoke.)
But the general theme that drove the entire conversation was, as mentioned above, what happens when cost trumps care and short-term political concerns dwarf long-term consequences.
And, no matter what language you're speaking, it sure sounds familiar. Read More & Comment...
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