Latest Drugwonks' Blog
Wallace and Gromit help to fight obesity
Fri Jan 2, 12:08 pm ET
LONDON (AFP) – The government launched a campaign to fight the nation's expanding waistlines on Friday with a cartoon by the Oscar-winning animators of Wallace and Gromit to hammer home the message.
The TV adverts by Nick Park's Aardman Animations featuring plasticine figures is the centrepiece of the Change4Life drive to reduce the 9,000 premature deaths linked to obesity in Britain every year.
The campaign, which includes 75 million pounds of government marketing cash over three years, and support from 33 companies, aims to reverse the forecast that by 2050 up to 90 percent of today's children will be overweight or obese.
"Change4Life has a critical ambition, we are trying to create a lifestyle revolution on a huge scale, something which no government has attempted before," said public health minister Dawn Primarolo.
Chief Medical Officer Liam Donaldson said people were increasingly ignorant of the risks of over-eating and lack of activity.
"The research we undertook for this campaign showed that only six percent of people understood the links between obesity, overweight and adverse health effects," he said.
The first brightly coloured Nick Park advert shows primitive man evolving from a hunter gathering his own food to a sedentary lifestyle in front of the TV before he is shocked into taking exercise by illustrations of fat pumping around the body.
The campaign slogan is "Eat well, move more, live longer".
On December 27th, China passed a new patent law that will allow domestic Chinese pharmaceutical manufacturers to manufacture knock-offs of on-patent medicines – and export them to third countries. According to Yin Xintian, director the regulations department of China’s State Intellectual Property Office, the new law will “ensure patients can get the drugs they need when they need them.”
It will also be a boon to China’s pharmaceutical manufacturing industry. Oh well, at least we know that quality won’t be a problem.
The new Chinese law is based on TRIPS – and is the latest example of how international organizations are wrecking havoc with the keystone of medical innovation – intellectual property rights.
It should also serve as a potent reminder that Secretary of State-Designate Hillary Clinton will indeed have an important role in healthcare reform – albeit of an international nature. And the implications for continued U.S. support of intellectual property rights could be profound.
Many in healthcare policy land were pleased that Senator Clinton was tapped by President-Elect Obama to head the State Department because it would (in the words of more than a few) “get her out of the healthcare reform debate.”
Not so fast.
By moving into the corner office at Foggy Bottom, Mrs. Clinton will be a force majeure in global healthcare issues by dint of her ability to appoint and otherwise influence the United States delegations to the many Geneva-based organizations that address issues such as compulsory licensing (the World Trade Organization) and access to healthcare issues (the World Health Organization).
The U.S. has long been a bulwark in support of global intellectual property rights – and Mrs. Clinton should be questioned about her views on this and related issues during her upcoming Senate confirmation hearing.
It will also be a boon to China’s pharmaceutical manufacturing industry. Oh well, at least we know that quality won’t be a problem.
The new Chinese law is based on TRIPS – and is the latest example of how international organizations are wrecking havoc with the keystone of medical innovation – intellectual property rights.
It should also serve as a potent reminder that Secretary of State-Designate Hillary Clinton will indeed have an important role in healthcare reform – albeit of an international nature. And the implications for continued U.S. support of intellectual property rights could be profound.
Many in healthcare policy land were pleased that Senator Clinton was tapped by President-Elect Obama to head the State Department because it would (in the words of more than a few) “get her out of the healthcare reform debate.”
Not so fast.
By moving into the corner office at Foggy Bottom, Mrs. Clinton will be a force majeure in global healthcare issues by dint of her ability to appoint and otherwise influence the United States delegations to the many Geneva-based organizations that address issues such as compulsory licensing (the World Trade Organization) and access to healthcare issues (the World Health Organization).
The U.S. has long been a bulwark in support of global intellectual property rights – and Mrs. Clinton should be questioned about her views on this and related issues during her upcoming Senate confirmation hearing.
By Michael Kahn
LONDON (Reuters) - Many genes linked to various cancers do not appear to raise the risk of getting cancer after all, according to an analysis of hundreds of studies published on Tuesday.
The findings highlight the need to exercise caution over the increasing number of studies associating common genetic variations with a range of diseases, said John Ioannidis of the University of Ioannina School of Medicine in Greece.
"The whole thing about genetic variations and links to diseases like cancer are very exciting, but the general public should be quite cautious about jumping to the conclusion that if they have a change in one gene or another they are doomed," Ioannidis, who led the study, said in a telephone interview.
"Genetic effects are very complex and very subtle and we need to know a lot more before we can make strong recommendations based on genetic profiles."
Ioannidis said his team had looked only at common genetic changes or polymorphisms, not at rare mutations, which in genes such as BRCA1 and BRCA2 significantly raise breast cancer risk. The rare form of these variants, for example, accounts for an estimated 5 to 10 percent of breast cancers.
Since early 2007, variations at more than 100 places on the genome have been linked to diabetes, heart disease and certain cancers.
The problem, researchers say, is that many of these genes typically interact in a complicated manner and their ultimate effects are influenced by the environment -- diet, exercise, smoking and other behavior -- in often poorly understood ways.
Ioannidis and his colleague Paolo Vineis of Imperial College London analyzed hundreds of published studies linking genetic changes to different cancers. They found that, out of 240 associations between a specific mutation and a cancer, only two genes involved in DNA repair and tied to lung cancer -- XRCC1 and ERCC2 -- turned out to be strong candidates for such a link.
"Most of the associations had weak or modest credibility," he said. That included PARP1 for breast cancer and CCND1 for head and neck tumors.
The problem is that on their own, the earlier studies fail to provide a complete picture and run the risk of drawing conclusions from too limited an amount of data, Ioannidis said.
This does not mean studies linking genes to cancer and the risk of other diseases have completely missed the mark, but rather that it takes a mountain of evidence to reach strong conclusions when it comes to the human genome, he added.
"Our study shows that it really takes a lot of research effort and many, many studies to be able to pinpoint a couple of associations," Ioannidis said.
(Reporting by Michael Kahn; editing by Maggie Fox and Tim Pearce)
I was in Israel this past summer visiting the National Biotechnology Institute of the Negev (NBIN) which is outside of Beersheva. The genesis of NBIN was the collection of genetic data from Bedouins as part of a health clinic Ben Gurion University established for that nomadic people. Now NBIN has a powerful platform for developing genetic markers for diseases, particularly those that afflict the Arab world. NBIN -- along with school chidren, synagogues, day care centers, hospitals and the very health clinics mentioned above -- is now within the range of rockets being fired by Hamas, rockets acquired during a "cease fire."
Those who seek to establish a moral equivalence between Israel and it's enemies, particularly journalists, lack both conscience and context.
Those who seek to establish a moral equivalence between Israel and it's enemies, particularly journalists, lack both conscience and context.
Steve Nissen believes that drugs should be evaluated strictly in terms of survival ... I guess quality of life means nothing.
See here.
A study published in July showed that diabetics who take insulin plus a diabetes pill have a lower risk of developing Alzheimer's disease than diabetics who take insulin alone.
Oh and that pill? Avandia or Actos. How many people are NOT on either thanks to Nissen's cardiovascular fearmongering?
See here.
A study published in July showed that diabetics who take insulin plus a diabetes pill have a lower risk of developing Alzheimer's disease than diabetics who take insulin alone.
Oh and that pill? Avandia or Actos. How many people are NOT on either thanks to Nissen's cardiovascular fearmongering?
The Wall Street Journal, reports that, “Amid studies showing the anti-clotting drug Plavix may not be effective for 30% of cardiac patients, federal regulators are considering updating the drug's label to include data on genetic factors that could interfere with the medicine.”
(Nearly 25 million prescriptions were written in the U.S. in 2007.)
“The issues concerning Plavix show the promise and problems with the new area of "personalized medicine," where drugs are tailored to certain people based on their genetic makeup. In Plavix’s case, the three studies pinpointed a likely genetic factor inhibiting the drug's efficacy -- but that finding has opened up more unanswered questions.”
“Unanswered questions” are a good thing – it means that we’re now being forced to think hard about how to address these new facts. Nobody said personalized medicine was going to be easy.
Three studies last week -- two in the New England Journal of Medicine and one in the Lancet -- identified a genetic abnormality in some heart patients that could interfere with their liver's ability to completely process Plavix in the bloodstream, but they differed on the number of patients affected.Two of the studies suggested the drug was less effective in about 30% of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5% of the population that has the gene from both parents.
According to Larry Lesko, director of the FDA's office of clinical pharmacology, "What I think we're struggling with is what is the label going to say in light of all the ambiguous data out there."
That’s a key point to remember – that “personalized” labeling is not a black-and-white proposition. And it’s the FDA’s job to review all of the information (much of it vague and contradictory) and then make the best choice on behalf of the public health. Larry Lesko’s honesty acknowledges some tough truths about drug regulation – like the nascent nature of the agency’s understanding of pharmacogenomics relative to “safe use” and the dearth of 21st regulatory tools to explore it.
These new studies mean "life just got very confused and much more complex" for cardiologists and patients, said Dr. James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."
Indeed, not “safety” per se, but “safe use.”
According to Dr. Lesko, the agency is considering amending the Plavix label to recommend that patients get a genetic test to screen them for the gene mutation. This is similar in concept to the FDA’s change to the Warfarin label – but with one big difference ... at present there aren't any alternatives to Plavix approved for use in the United States. "Once you know the answer, what do you do?" said Douglas Weaver, president of the American College of Cardiology.
Good question – and one that the FDA should acknowledge and take into consideration as it reviews the various safety profiles of new medicines that could fill this gap.
Dr. Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, said, "Clearly I think just the blind administration of these drugs is rapidly coming to an end."
Dr. Grubel’s comment is a clarion call that the era of “trial-and-error” medicine is over. One size does not fit all. Not for anti-clotting drugs, not for cancer medications, not for statins.
The Journal article opines that, “The new Plavix studies may give a boost to personalized medicine as a cost-saving measure under President-elect Barack Obama. As an Illinois senator, he introduced a bill in Congress encouraging genomic research and personalized medicine that would "target the delivery of health care." Insurance companies might be able to limit prescriptions for Plavix based on patients' genetic makeup, as they do now with some cancer drugs.”
First of all, news articles shouldn't opine. Secondly, personalized medicine is not about denying care. It’s about providing the right care. The four rights (right medicine at the right time to the right patient in the right dose). And as far as “cost-savings” are concerned, not providing Plavix to some subset of patients (and particularly one as potentially large as 30%) doesn’t mean these patients don’t need treatment – it means they need alternate treatment, newer therapy, therapy that may cost more than Plavix does today – and considerably more once it goes off-patent.
And as far as former Senator Obama’s “Genomics and Personalized Medicine Act,” goes – I look forward to hearing about its passage during his first State of the Union address.
(Nearly 25 million prescriptions were written in the U.S. in 2007.)
“The issues concerning Plavix show the promise and problems with the new area of "personalized medicine," where drugs are tailored to certain people based on their genetic makeup. In Plavix’s case, the three studies pinpointed a likely genetic factor inhibiting the drug's efficacy -- but that finding has opened up more unanswered questions.”
“Unanswered questions” are a good thing – it means that we’re now being forced to think hard about how to address these new facts. Nobody said personalized medicine was going to be easy.
Three studies last week -- two in the New England Journal of Medicine and one in the Lancet -- identified a genetic abnormality in some heart patients that could interfere with their liver's ability to completely process Plavix in the bloodstream, but they differed on the number of patients affected.Two of the studies suggested the drug was less effective in about 30% of the population that has the mutated gene from one parent, while one study indicated the drug is less effective in the 5% of the population that has the gene from both parents.
According to Larry Lesko, director of the FDA's office of clinical pharmacology, "What I think we're struggling with is what is the label going to say in light of all the ambiguous data out there."
That’s a key point to remember – that “personalized” labeling is not a black-and-white proposition. And it’s the FDA’s job to review all of the information (much of it vague and contradictory) and then make the best choice on behalf of the public health. Larry Lesko’s honesty acknowledges some tough truths about drug regulation – like the nascent nature of the agency’s understanding of pharmacogenomics relative to “safe use” and the dearth of 21st regulatory tools to explore it.
These new studies mean "life just got very confused and much more complex" for cardiologists and patients, said Dr. James Calvin, director of cardiology at Rush University Medical Center in Chicago. He added, "We have to start to become very, very aware of how big an issue this is."
Indeed, not “safety” per se, but “safe use.”
According to Dr. Lesko, the agency is considering amending the Plavix label to recommend that patients get a genetic test to screen them for the gene mutation. This is similar in concept to the FDA’s change to the Warfarin label – but with one big difference ... at present there aren't any alternatives to Plavix approved for use in the United States. "Once you know the answer, what do you do?" said Douglas Weaver, president of the American College of Cardiology.
Good question – and one that the FDA should acknowledge and take into consideration as it reviews the various safety profiles of new medicines that could fill this gap.
Dr. Paul Gurbel, who authored one of the first studies showing that many heart patients don't process Plavix effectively, said, "Clearly I think just the blind administration of these drugs is rapidly coming to an end."
Dr. Grubel’s comment is a clarion call that the era of “trial-and-error” medicine is over. One size does not fit all. Not for anti-clotting drugs, not for cancer medications, not for statins.
The Journal article opines that, “The new Plavix studies may give a boost to personalized medicine as a cost-saving measure under President-elect Barack Obama. As an Illinois senator, he introduced a bill in Congress encouraging genomic research and personalized medicine that would "target the delivery of health care." Insurance companies might be able to limit prescriptions for Plavix based on patients' genetic makeup, as they do now with some cancer drugs.”
First of all, news articles shouldn't opine. Secondly, personalized medicine is not about denying care. It’s about providing the right care. The four rights (right medicine at the right time to the right patient in the right dose). And as far as “cost-savings” are concerned, not providing Plavix to some subset of patients (and particularly one as potentially large as 30%) doesn’t mean these patients don’t need treatment – it means they need alternate treatment, newer therapy, therapy that may cost more than Plavix does today – and considerably more once it goes off-patent.
And as far as former Senator Obama’s “Genomics and Personalized Medicine Act,” goes – I look forward to hearing about its passage during his first State of the Union address.
Earlier we commented on the future path of Britain’s National Health Service as spelled out in the “Darzi Report.” (“Do you deny it, Mr. Darzi”)
One of Lord Darzi's recommendations is that NICE work faster so that the fine and timely work of the MHRA (the FDA’s sister agency in the United Kingdom) isn’t wasted.
According to NICE Chairman Sir Michael Rawlings, "Our ambition is to make sure guidance is available within three to six months.” He said this could be achieved by increasing the number of advisory committees and starting the evaluation process a year before a drug company expects to obtain a license. (Not a bad idea for similar action by CMS right here at home.)
That’s good news. What’s better news is that Sir Michael seems to be almost, kind of, sort of ready to reconsider NICE’s inflexible devotion to the Holy QALY.
According to the NICE chairman, "People attach a special importance to extending the lives of [those with] mortal illnesses, even for a few months, and we appreciate these extra weeks and months can be very special.”
Further, "We are proposing to provide our advisory bodies with supplementary advice ... which will have the effect of extending the threshold range of what we would normally regard as cost-effective."
Good golly! Miss QALY?
However, "We are not proposing to extend this to all conditions. Frankly, it would cost the NHS hundreds of millions of pounds."
Well, heaven forbid that the NHS should provide the best care when adequate care is available. That’s cost-based versus patient-centric care. That’s NICE.
In other words, when Sir Michael’s political masters feel the heat – NICE sees the light. This is a case (one not unknown in American politics) of the squeaky wheel getting the oil. And now that British citizens with “mortal illnesses” will finally be treated like human beings, it’s only a matter of time until every other segment of the British population figures out that where their best chances for best treatment lies – in public activism.
Is this any way to run an airline?
One of Lord Darzi's recommendations is that NICE work faster so that the fine and timely work of the MHRA (the FDA’s sister agency in the United Kingdom) isn’t wasted.
According to NICE Chairman Sir Michael Rawlings, "Our ambition is to make sure guidance is available within three to six months.” He said this could be achieved by increasing the number of advisory committees and starting the evaluation process a year before a drug company expects to obtain a license. (Not a bad idea for similar action by CMS right here at home.)
That’s good news. What’s better news is that Sir Michael seems to be almost, kind of, sort of ready to reconsider NICE’s inflexible devotion to the Holy QALY.
According to the NICE chairman, "People attach a special importance to extending the lives of [those with] mortal illnesses, even for a few months, and we appreciate these extra weeks and months can be very special.”
Further, "We are proposing to provide our advisory bodies with supplementary advice ... which will have the effect of extending the threshold range of what we would normally regard as cost-effective."
Good golly! Miss QALY?
However, "We are not proposing to extend this to all conditions. Frankly, it would cost the NHS hundreds of millions of pounds."
Well, heaven forbid that the NHS should provide the best care when adequate care is available. That’s cost-based versus patient-centric care. That’s NICE.
In other words, when Sir Michael’s political masters feel the heat – NICE sees the light. This is a case (one not unknown in American politics) of the squeaky wheel getting the oil. And now that British citizens with “mortal illnesses” will finally be treated like human beings, it’s only a matter of time until every other segment of the British population figures out that where their best chances for best treatment lies – in public activism.
Is this any way to run an airline?
Per yesterday’s blog, “Diagnostical Materialism,” have a look at the latest article in the New York Times’ “Evidence Gap” series, “Patient’s DNA May Be Signal to Tailor Medication.”
Here’s a paragraph to whet your appetite:
“Many policy experts are calling for more studies to compare the effectiveness of different treatments. One drawback is that such studies tend to be one size fits all, with the winning treatment recommended for everybody. Personalized medicine would go beyond that by determining which drug is best for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.”
A worthwhile read.
Here’s a paragraph to whet your appetite:
“Many policy experts are calling for more studies to compare the effectiveness of different treatments. One drawback is that such studies tend to be one size fits all, with the winning treatment recommended for everybody. Personalized medicine would go beyond that by determining which drug is best for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.”
A worthwhile read.
Hasn't the New York Times ever heard of retail health clinics?
Molecular diagnostics are what make medicines personal. Diagnostics are how drugs can be made “safer” -- through “safe use.” They make the “four rights” (right medicine for the right patient in the right dose at the right time) possible. And the four rights lead to lower costs through better outcomes.
Case in point: Warfarin, the most widely used anti-coagulant medication in the world. Prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes, patients can display markedly different responses to the drug. Doses vary enormously between individuals; so achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, while those who receive too low a dose may remain at risk of life-threatening blood clots. Via molecular diagnostics specifically called out in the amended FDA label, physicians will prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the United States. And this “safer use” is estimated to save $1.1 billion annually. And that’s the mid-range.
But diagnostics are in trouble. And that trouble comes in the form of skittish reimbursement and ambiguous regulation.
On the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial.
Case in point: Herceptin. Studies show that Her2 testing for breast cancer delivers savings that are 65x its cost. For a very powerful presentation on the economics of the Her2 test and molecular diagnostics in general see here.
In short, reimbursement should be based on value rather than activity. This is an essential (you should excuse the expression) paradigm shift.
On the regulatory front clarity and predictability are required. FDA approved the molecular diagnostic for warfarin based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. But guidance on diagnostic approvals are vague as is the pathway. To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review. This should be a top priority of the agency’s Critical Path program.
Unless and until the reimbursement and regulatory issues are addressed, investment in developing these tools will languish, patients will needlessly suffer and our healthcare system will continue to be burdened by unnecessary costs.
If the popular culture clarion call is for “safer drugs,” then the path forward shouldn’t include beating up Big Pharma or reversing FDA preemption authority – it’s via molecular diagnostics.
Case in point: Warfarin, the most widely used anti-coagulant medication in the world. Prescribed to over 2 million people a year to prevent blood clots, heart attacks and strokes, patients can display markedly different responses to the drug. Doses vary enormously between individuals; so achieving the correct dose is critical, as patients who receive too high a dose are at risk of severe bleeding, while those who receive too low a dose may remain at risk of life-threatening blood clots. Via molecular diagnostics specifically called out in the amended FDA label, physicians will prevent 85,000 serious bleeding events and 17,000 strokes annually – and that’s just in the United States. And this “safer use” is estimated to save $1.1 billion annually. And that’s the mid-range.
But diagnostics are in trouble. And that trouble comes in the form of skittish reimbursement and ambiguous regulation.
On the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial.
Case in point: Herceptin. Studies show that Her2 testing for breast cancer delivers savings that are 65x its cost. For a very powerful presentation on the economics of the Her2 test and molecular diagnostics in general see here.
In short, reimbursement should be based on value rather than activity. This is an essential (you should excuse the expression) paradigm shift.
On the regulatory front clarity and predictability are required. FDA approved the molecular diagnostic for warfarin based on a broad range of published literature together with the results of a study, conducted by the manufacturer, on hundreds of DNA samples. But guidance on diagnostic approvals are vague as is the pathway. To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review. This should be a top priority of the agency’s Critical Path program.
Unless and until the reimbursement and regulatory issues are addressed, investment in developing these tools will languish, patients will needlessly suffer and our healthcare system will continue to be burdened by unnecessary costs.
If the popular culture clarion call is for “safer drugs,” then the path forward shouldn’t include beating up Big Pharma or reversing FDA preemption authority – it’s via molecular diagnostics.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
