Latest Drugwonks' Blog
From The Times of London ...
Hospitals fight NHS ban on patients using private drugs
Sarah-Kate Templeton, Health Editor
HOSPITAL chiefs are demanding an urgent review of the government’s policy of withdrawing National Health Service care from patients who pay privately for additional cancer medicines.
The NHS Confederation, which represents hospital chief executives and managers, says denying NHS treatment to patients who pay for top-up drugs is “perverse†and against “common senseâ€.
The move comes after it emerged that women suffering from breast cancer have been threatened with losing NHS care if they seek to improve their chances by paying privately for an extra drug.
Ministers claim that to allow patients to pay for top-up drugs would be unfair on those who cannot afford them and lead to a two-tier NHS. Their policy was laid down in guidance issued this summer but was criticised last week after The Sunday Times highlighted the case of Colette Mills, 58, from near Stokesley, North Yorkshire.
Mills, a former nurse, has been told that if she pays for the cancer drug Avastin, which the NHS does not fund, she will have to foot the £10,000 total monthly bill for her care.
Another breast cancer patient, Debbie Hirst, 56, from St Ives, Cornwall, has now revealed that she, too, has been told that if she wants to pay for Avastin in addition to her NHS medicines, she will be forced to pay for all her care.
The Royal Cornwall Hospitals NHS Trust issued the threat despite three other patients being allowed to top up their NHS care. The trust says the three had started their private treatment before the guidance was issued.
Hirst, a grandmother, said: “We put our house up for sale in order to pay for this drug. My only option now is to take the treatment they offer on the NHS or go private, which would be totally unaffordable.â€
Nigel Edwards, the NHS Confederation’s director of policy, said: “The position appears to run counter to common sense. This should ring alarm bells that something is wrong with the policy.â€
Edwards said patients are already regularly combining private and NHS care. For example, thousands mix NHS dental care with treatments available only privately.
Co-payments should be allowed, he said, provided they did not deprive other patients of resources, and those paying for the drugs are well informed of their limitations.
It was also reported yesterday that a 62-year-old woman had won a legal battle for the right to be treated with Avastin for bowel cancer. She will pay for the drug while Cumbria Primary Care Trust funds the rest of her care.
Mills and Hirst are to launch a campaign for all patients to have the right to pay for medicines not funded on the NHS. They are backed by the Patients Association, Doctors for Reform and Saga, the organisation for the over-fifties.
Andrew Goodsell, Saga chief executive, said: “People are less concerned about a two-tier health service than whether they have the opportunity to resolve what can be a life or death situation.â€
The health department said: “It is a fundamental principle of the NHS, supported by all the main political parties, that treatment should be free at the point of need. Co-payments would undermine this.â€
Hospitals fight NHS ban on patients using private drugs
Sarah-Kate Templeton, Health Editor
HOSPITAL chiefs are demanding an urgent review of the government’s policy of withdrawing National Health Service care from patients who pay privately for additional cancer medicines.
The NHS Confederation, which represents hospital chief executives and managers, says denying NHS treatment to patients who pay for top-up drugs is “perverse†and against “common senseâ€.
The move comes after it emerged that women suffering from breast cancer have been threatened with losing NHS care if they seek to improve their chances by paying privately for an extra drug.
Ministers claim that to allow patients to pay for top-up drugs would be unfair on those who cannot afford them and lead to a two-tier NHS. Their policy was laid down in guidance issued this summer but was criticised last week after The Sunday Times highlighted the case of Colette Mills, 58, from near Stokesley, North Yorkshire.
Mills, a former nurse, has been told that if she pays for the cancer drug Avastin, which the NHS does not fund, she will have to foot the £10,000 total monthly bill for her care.
Another breast cancer patient, Debbie Hirst, 56, from St Ives, Cornwall, has now revealed that she, too, has been told that if she wants to pay for Avastin in addition to her NHS medicines, she will be forced to pay for all her care.
The Royal Cornwall Hospitals NHS Trust issued the threat despite three other patients being allowed to top up their NHS care. The trust says the three had started their private treatment before the guidance was issued.
Hirst, a grandmother, said: “We put our house up for sale in order to pay for this drug. My only option now is to take the treatment they offer on the NHS or go private, which would be totally unaffordable.â€
Nigel Edwards, the NHS Confederation’s director of policy, said: “The position appears to run counter to common sense. This should ring alarm bells that something is wrong with the policy.â€
Edwards said patients are already regularly combining private and NHS care. For example, thousands mix NHS dental care with treatments available only privately.
Co-payments should be allowed, he said, provided they did not deprive other patients of resources, and those paying for the drugs are well informed of their limitations.
It was also reported yesterday that a 62-year-old woman had won a legal battle for the right to be treated with Avastin for bowel cancer. She will pay for the drug while Cumbria Primary Care Trust funds the rest of her care.
Mills and Hirst are to launch a campaign for all patients to have the right to pay for medicines not funded on the NHS. They are backed by the Patients Association, Doctors for Reform and Saga, the organisation for the over-fifties.
Andrew Goodsell, Saga chief executive, said: “People are less concerned about a two-tier health service than whether they have the opportunity to resolve what can be a life or death situation.â€
The health department said: “It is a fundamental principle of the NHS, supported by all the main political parties, that treatment should be free at the point of need. Co-payments would undermine this.â€
Soldiers, that is, on behalf of the public health.
From the pages of the Buffalo News ...
Innovation can’t survive without ownership
By Peter Pitts
If you wrote a book, would you be happy to see it published under someone else’s name?
What if you spent several years of your life — and invested a large chunk of your savings — developing a new product that made life easier for you and your family? Would you regret having done so if it became “public property†at the stroke of a lawmaker’s pen?
It would probably be the end of your inventing career.
Yet when it comes to lifesaving drugs and treatments, some seem to believe that the rules of human nature and economic reality don’t apply.
In Thailand, the military-appointed government has granted the stateowned Government Pharmaceutical Organization (GPO) the authority to produce generic versions of several patented medicines. The Thai government has claimed that its goal is to provide these drugs to poor Thais, but in reality, government leaders are hoping that the GPO will become a new and highly profitable hub for the manufacture and export of all manner of copycat drugs.
Amazingly, such actions are supported by public health activists and nongovernmental organizations. Earlier this month, representatives from Doctors without Borders, Oxfam International and other organizations defended the Thai junta’s actions at a conference on drug patents held in Thailand.
And earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for the Thai government’s renegade action. But history demonstrates the folly of such actions.
In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death†in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.
In other words, even if the elimination of patent rights makes drugs less costly, it doesn’t produce greater access.
There is a reason why virtually all the world’s “miracle drugs†have been developed in Western countries. It’s called incentive. Because innovation is honored and protected, inventors are rewarded for their work.
Unfortunately, once a lifesaving drug or treatment exists, it’s seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality.
And because we need it, we expect it to be free. But if we allow our emotions to trump reason, and cloud our minds to the realities of human nature and economics 101, we’ll end up with a lot less innovation.
And fewer lifesaving drugs to take for granted.
From the pages of the Buffalo News ...
Innovation can’t survive without ownership
By Peter Pitts
If you wrote a book, would you be happy to see it published under someone else’s name?
What if you spent several years of your life — and invested a large chunk of your savings — developing a new product that made life easier for you and your family? Would you regret having done so if it became “public property†at the stroke of a lawmaker’s pen?
It would probably be the end of your inventing career.
Yet when it comes to lifesaving drugs and treatments, some seem to believe that the rules of human nature and economic reality don’t apply.
In Thailand, the military-appointed government has granted the stateowned Government Pharmaceutical Organization (GPO) the authority to produce generic versions of several patented medicines. The Thai government has claimed that its goal is to provide these drugs to poor Thais, but in reality, government leaders are hoping that the GPO will become a new and highly profitable hub for the manufacture and export of all manner of copycat drugs.
Amazingly, such actions are supported by public health activists and nongovernmental organizations. Earlier this month, representatives from Doctors without Borders, Oxfam International and other organizations defended the Thai junta’s actions at a conference on drug patents held in Thailand.
And earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for the Thai government’s renegade action. But history demonstrates the folly of such actions.
In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death†in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.
In other words, even if the elimination of patent rights makes drugs less costly, it doesn’t produce greater access.
There is a reason why virtually all the world’s “miracle drugs†have been developed in Western countries. It’s called incentive. Because innovation is honored and protected, inventors are rewarded for their work.
Unfortunately, once a lifesaving drug or treatment exists, it’s seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality.
And because we need it, we expect it to be free. But if we allow our emotions to trump reason, and cloud our minds to the realities of human nature and economics 101, we’ll end up with a lot less innovation.
And fewer lifesaving drugs to take for granted.
From the pages of FDA News ...
Critical Path Wants Adaptive Clinical Trial Designs, Temple Says
The FDA is encouraging the use of adaptive trials, saying the practice will modernize the development process and shorten the time needed to show a drug is effective. The agency’s associate director for medical policy, Robert Temple, said the Critical Path Initiative encourages the use of this kind of trial when researchers use accumulating data to modify the ongoing trial. Temple, speaking at the Critical Path Executive Briefing sponsored by FDAnews and the Center for Medicine in the Public Interest, said the FDA is working on an adaptive design guidance it promised to release in 2008.
Some of the more familiar adaptations include changing sample sizes based on variance and starting and dropping extra trial groups. When researchers determine a drug effect is present in a population subset, they can adapt the trial by modifying the trial’s entry criteria or increasing the number of patients assigned to receive the effective treatment.
While almost every clinical trial uses enrichment in some way to improve the trial’s patient population, there are more steps that can be taken to increase the chances a drug effect is detected, Temple said. Some enrichment efforts can decrease variants while others can choose high-risk patients or patients more likely to respond to treatment because of some genetic characteristic.
“Everyone agrees about finding the people who are most likely to respond … it enormously enhances the power of the study,†Temple said. Enrichment will help researchers by decreasing heterogeneity and identifying a population that responds to the treatment.
For example, researchers can screen patients with the treatment first and then enroll them in the study if they respond to the drug. In addition, researchers can study a large group of patients and only randomize those with a good response.
Scientists are beginning to be able to search for genetic characteristics or other factors that will predict a patient’s response to a drug, Temple said. Part of the Critical Path Initiative is to identify biomarkers and determine why some patients and not others experience adverse events with the same drug.
Researchers can select trial subjects based on either understanding of a disease or a drug mechanism, but they also can run a trial in patients to link a genetic baseline finding with a drug response, Temple added.
Critical Path Wants Adaptive Clinical Trial Designs, Temple Says
The FDA is encouraging the use of adaptive trials, saying the practice will modernize the development process and shorten the time needed to show a drug is effective. The agency’s associate director for medical policy, Robert Temple, said the Critical Path Initiative encourages the use of this kind of trial when researchers use accumulating data to modify the ongoing trial. Temple, speaking at the Critical Path Executive Briefing sponsored by FDAnews and the Center for Medicine in the Public Interest, said the FDA is working on an adaptive design guidance it promised to release in 2008.
Some of the more familiar adaptations include changing sample sizes based on variance and starting and dropping extra trial groups. When researchers determine a drug effect is present in a population subset, they can adapt the trial by modifying the trial’s entry criteria or increasing the number of patients assigned to receive the effective treatment.
While almost every clinical trial uses enrichment in some way to improve the trial’s patient population, there are more steps that can be taken to increase the chances a drug effect is detected, Temple said. Some enrichment efforts can decrease variants while others can choose high-risk patients or patients more likely to respond to treatment because of some genetic characteristic.
“Everyone agrees about finding the people who are most likely to respond … it enormously enhances the power of the study,†Temple said. Enrichment will help researchers by decreasing heterogeneity and identifying a population that responds to the treatment.
For example, researchers can screen patients with the treatment first and then enroll them in the study if they respond to the drug. In addition, researchers can study a large group of patients and only randomize those with a good response.
Scientists are beginning to be able to search for genetic characteristics or other factors that will predict a patient’s response to a drug, Temple said. Part of the Critical Path Initiative is to identify biomarkers and determine why some patients and not others experience adverse events with the same drug.
Researchers can select trial subjects based on either understanding of a disease or a drug mechanism, but they also can run a trial in patients to link a genetic baseline finding with a drug response, Temple added.
Commenting on the current state of 21st century bioinformatics, Dr. Janet Woodcock quipped that, "Today the major tool of modern medicine seems to the clipboard."
And that gave us an idea – a new award for those who impede (unwittingly or otherwise) the advance of medical progress -- "The Golden Clipboard."
Herewith our 2007 honorees …
Honorable Mention: Representative Rosa DeLauro
An honorable mention goes to Representative Rosa DeLauro for her perplexing efforts to embog the work of the Reagan/Udall Critical Path Foundation. Ms. DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path in general. She has stated: “I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials. The Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy.†This is all the more surprising and concerning considering the fact that Ms. DeLauro chairs the appropriations subcommittee that funds the FDA.
We hope that Ms. DeLauro’s tenacity towards improving the FDA and passion for protecting the public health can be harnessed and redirected to better purposes in 2008.
The Bronze Clipboard: Representative Henry Waxman
A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDA’s sound scientific policy towards “non-inferiority†trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.
In addition to his role as Congressional Oversighter-in-Chief, Mr. Waxman is one of the most knowledgeable members of Congress when it comes to how the FDA works and what it needs to succeed – and we look forward to his efforts to help the agency pursue its mission of both protecting and advancing the public health in 2008.
The Silver Clipboard: Dr. Steven Nissen
Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.†A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.†What’s the frequency, Steve?
Regularly positioning himself as “Dr. Transparency,†Dr. Nissen regularly neglected to come clean about his various consulting arrangements, conflicts and clinical trial activities. That, and his public flailing of drugwonks.com as “vile,†earns him this year’s Silver Clipboard and (at least hopefully) removes his name from any plausible consideration for FDA Commissioner anytime in the 21st century.
AND THE WINNER OF THE 2007 GOLDEN CLIPBOARD GOES TO
(Drum roll please …)
2007 Golden Clipboard Winner: Dr. David Graham
David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite “conversations.†Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides. Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint – the same sort of science that, when it came to Vioxx, he rejected as insufficient.
Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,†he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.
For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.
And that gave us an idea – a new award for those who impede (unwittingly or otherwise) the advance of medical progress -- "The Golden Clipboard."
Herewith our 2007 honorees …
Honorable Mention: Representative Rosa DeLauro
An honorable mention goes to Representative Rosa DeLauro for her perplexing efforts to embog the work of the Reagan/Udall Critical Path Foundation. Ms. DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path in general. She has stated: “I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials. The Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy.†This is all the more surprising and concerning considering the fact that Ms. DeLauro chairs the appropriations subcommittee that funds the FDA.
We hope that Ms. DeLauro’s tenacity towards improving the FDA and passion for protecting the public health can be harnessed and redirected to better purposes in 2008.
The Bronze Clipboard: Representative Henry Waxman
A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDA’s sound scientific policy towards “non-inferiority†trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.
In addition to his role as Congressional Oversighter-in-Chief, Mr. Waxman is one of the most knowledgeable members of Congress when it comes to how the FDA works and what it needs to succeed – and we look forward to his efforts to help the agency pursue its mission of both protecting and advancing the public health in 2008.
The Silver Clipboard: Dr. Steven Nissen
Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.†A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.†What’s the frequency, Steve?
Regularly positioning himself as “Dr. Transparency,†Dr. Nissen regularly neglected to come clean about his various consulting arrangements, conflicts and clinical trial activities. That, and his public flailing of drugwonks.com as “vile,†earns him this year’s Silver Clipboard and (at least hopefully) removes his name from any plausible consideration for FDA Commissioner anytime in the 21st century.
AND THE WINNER OF THE 2007 GOLDEN CLIPBOARD GOES TO
(Drum roll please …)
2007 Golden Clipboard Winner: Dr. David Graham
David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite “conversations.†Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides. Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint – the same sort of science that, when it came to Vioxx, he rejected as insufficient.
Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,†he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.
For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.
While we dither about funding for the Reagan/Udall Center, the European Commission and the pharmaceutical industry have unveiled a €2 billion partnership to reverse the EU's declining international role in medical research. According to a report in the Financial Times, teams of commercial and not-for-profit researchers will be able to seek support for work on a range of medical projects, on condition that their findings are publicly shared in an effort to stimulate faster and safer drug development.
The Innovative Medicines Initiative (IMI), jointly supported by the Commission and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), will shortly release details of its first 18 priorities, which will be funded by €123 million in awards to be given out by the spring of 2009.
This is a chance for us to really get back on the right foot," said Arthur Higgins, president of EFPIA and head of Bayer Healthcare of Germany. It was important for patients and the wealth and prosperity of
The first wave of projects includes the development of measurable biomarkers in the body to gauge the side-effects of new medicines on the kidneys and liver, as well as research into the basic mechanisms of pain, severe asthma, psychiatric disorders and neurodegenerative diseases.
The Commission has given €1 billion in funding for the seven-year program, which will be matched by support from pharmaceutical companies through loans of staff, laboratory equipment and libraries of compounds.
It’s time that we take the issue of 21st century medicine just as seriously.
Funding for Reagan/Udall now!
What does the European Commission know that Rosa DeLauro does not?
According to the Financial Times ...
The European Commission is poised to agree a groundbreaking €2bn ($2.9bn, £1.5bn) partnership with the pharmaceutical industry this week designed to win back Europe's place as a centre for global medical innovation.
The Innovative Medicines Initiative, financed equally by the industry and the Commission, will support research by academic and industry groups over seven years designed to speed up the predictable testing of the safety and efficacy of medicines. The move, part of the EU's "Lisbon agenda" to regain competitiveness, aims to boost collaboration between commercial companies, universities and regulators to more rapidly develop "pre-competitive" tests and accelerate the launch of innovative drugs.
According to the Financial Times ...
The European Commission is poised to agree a groundbreaking €2bn ($2.9bn, £1.5bn) partnership with the pharmaceutical industry this week designed to win back Europe's place as a centre for global medical innovation.
The Innovative Medicines Initiative, financed equally by the industry and the Commission, will support research by academic and industry groups over seven years designed to speed up the predictable testing of the safety and efficacy of medicines. The move, part of the EU's "Lisbon agenda" to regain competitiveness, aims to boost collaboration between commercial companies, universities and regulators to more rapidly develop "pre-competitive" tests and accelerate the launch of innovative drugs.
The Baltimore Sun reports that, “A long-running clash over the marketing of meat and milk from cloned animals is coming to a head in Washington as the government prepares to make a ruling that would allow the products to be sold to consumers for the first time.
Critics in Congress, including Sen. Barbara A. Mikulski of Maryland, are attempting to delay the action expected from the Food and Drug Administration, which could decide as early as this week to permit sales. These opponents are rushing to gain approval by Congress this week of a provision that would encourage the FDA to delay action until further studies are completed.â€
Here’s the complete story:
http://www.baltimoresun.com/news/health/bal-te.clone19dec19,0,6919236.story
According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words –GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
It's a contentious topic – but the fact is that the agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated. So, when people accuse the agency' of reaching a decision without either due regulatory process or focus on science, I say, where's the beef?
Critics in Congress, including Sen. Barbara A. Mikulski of Maryland, are attempting to delay the action expected from the Food and Drug Administration, which could decide as early as this week to permit sales. These opponents are rushing to gain approval by Congress this week of a provision that would encourage the FDA to delay action until further studies are completed.â€
Here’s the complete story:
http://www.baltimoresun.com/news/health/bal-te.clone19dec19,0,6919236.story
According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words –GRAS.
Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder†clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.
You want fries with that?
In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.
By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.
Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.
It's a contentious topic – but the fact is that the agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated. So, when people accuse the agency' of reaching a decision without either due regulatory process or focus on science, I say, where's the beef?
Appropriations agriculture subcommittee chairwoman Rosa DeLauro has no problem cutting funding to promote the Critical Path initiative. Perhaps it was to make room for about $24.5 million worth of earmarks for her district. That includes about " $400,000 for Connecticut oyster fisheries. DeLauro, who is a member of the Commerce, Justice and Science Subcommittee, received $4.9 million in earmarks in one bill (Agriculture) alone, the "" including $500,000 for the Henry C. Lee Institute of Forensic Science Cold Case Center at the University of New Haven. " That's the same amount and the same bill from which she cut out money for FDA's Critical Path foundation.
Now that's leadership.
View Article
Now that's leadership.
View Article
The omnibus spending package moving through Congress would block FDA from transferring any money to the Reagan-Udall Foundation, the research institution created by the FDA Amendments Act.
The FDAAA. which implemented a slew of new policies while reauthorizing industry user fees, stipulates that FDA provide between $500,000 and $1.25 million per year to the Reagan-Udall Foundation. But the omnibus appropriations bill specifically blocks FDA from transferring any money to the foundation.
The prime mover behind this is Representative Rosa DeLauro (D-CT) (who chairs the appropriations subcommittee that funds FDA). Ms. DeLauro believes the Reagan-Udall Foundation “has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.â€
That is just absurd. When a senior member of Congress can blatantly accuse the FDA and the pharmaceutical industry of wanting to lower standards for drug development and review, it illustrates just how low a point we have reached. It’s just the absolute nadir. A new low in politics trumping public health.
A 21st century Scopes Monkey Trial.
He that troubleth his own house shall inherit the wind:
and the fool shall be servant to the wise of heart.
Proverbs 11:29
The FDAAA. which implemented a slew of new policies while reauthorizing industry user fees, stipulates that FDA provide between $500,000 and $1.25 million per year to the Reagan-Udall Foundation. But the omnibus appropriations bill specifically blocks FDA from transferring any money to the foundation.
The prime mover behind this is Representative Rosa DeLauro (D-CT) (who chairs the appropriations subcommittee that funds FDA). Ms. DeLauro believes the Reagan-Udall Foundation “has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.â€
That is just absurd. When a senior member of Congress can blatantly accuse the FDA and the pharmaceutical industry of wanting to lower standards for drug development and review, it illustrates just how low a point we have reached. It’s just the absolute nadir. A new low in politics trumping public health.
A 21st century Scopes Monkey Trial.
He that troubleth his own house shall inherit the wind:
and the fool shall be servant to the wise of heart.
Proverbs 11:29
My oped on VA health care in the Washington Times
http://washingtontimes.com/article/20071218/EDITORIAL/800572185/1013/editorial
http://washingtontimes.com/article/20071218/EDITORIAL/800572185/1013/editorial
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