Latest Drugwonks' Blog
The article today in the WSJ about a “link†between ALS and statin drugs underscores how much of epidemiology is nothing but statistical self-gratification that has grown exponentially in the hopes of seducing self-important medical journals who in turn seek to whet the appetite of journalists looking for peril in every pill.
The ALS-statin connection could have been addressed easily by asking if there was an overall increase in the incidence or prevalence in ALS since the widespread use of statin drugs beginning in the 1980s, particularly among the elderly. There are careful registry data in virtually every Western country in the world on ALS patients, some dating back to the 1920s that capture every new case of ALS and measure against increases in total populations and various demographic characteristics.
ALS incidence and prevalence is virtually unchanged since the beginning of the century. So if statins have a direct causative effect it would have shown up by now. Why no one, let alone the author of the WSJ article did not ask this simple question is beyond me.
Now more interesting is the fact that Beatrice Golomb, who is studying the evil effects of statins, claims to have found a link between low cholesterol levels and violence Indeed, there are a handful of articles that claim to have seen this association after doing some data dredging. (Uh, maybe they should control for age since most crime is committed by young people and most young people have...low cholesterol, duh.) And they NIH is giving her money?
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11104842&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus
I can’t wait to the lawsuits flying around the claims that statins cause violent behavior. They WILL come.
Meanwhile, shame on WSJ's Jacob Goldstein and WHO's Ralph Edwards for even proposing that this is anything more than a coincidence. You give me four million data points and I will show you that there is a relationship between Jacob Goldstein and half the pregancies in Passaic, NJ.
http://blogs.wsj.com/health/2007/07/03/data-crunching-hints-at-risk-of-cholesterol-drugs/
The ALS-statin connection could have been addressed easily by asking if there was an overall increase in the incidence or prevalence in ALS since the widespread use of statin drugs beginning in the 1980s, particularly among the elderly. There are careful registry data in virtually every Western country in the world on ALS patients, some dating back to the 1920s that capture every new case of ALS and measure against increases in total populations and various demographic characteristics.
ALS incidence and prevalence is virtually unchanged since the beginning of the century. So if statins have a direct causative effect it would have shown up by now. Why no one, let alone the author of the WSJ article did not ask this simple question is beyond me.
Now more interesting is the fact that Beatrice Golomb, who is studying the evil effects of statins, claims to have found a link between low cholesterol levels and violence Indeed, there are a handful of articles that claim to have seen this association after doing some data dredging. (Uh, maybe they should control for age since most crime is committed by young people and most young people have...low cholesterol, duh.) And they NIH is giving her money?
http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=11104842&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstractPlus
I can’t wait to the lawsuits flying around the claims that statins cause violent behavior. They WILL come.
Meanwhile, shame on WSJ's Jacob Goldstein and WHO's Ralph Edwards for even proposing that this is anything more than a coincidence. You give me four million data points and I will show you that there is a relationship between Jacob Goldstein and half the pregancies in Passaic, NJ.
http://blogs.wsj.com/health/2007/07/03/data-crunching-hints-at-risk-of-cholesterol-drugs/
NICE = the National Institute for Clinical Excellence -- the United Kingdom's center for deciding which medicines will be reimbursed. But more and more Britains are calling it by another, more descriptive acronym -- NASTY: Not Available So Treat Yourself.
To that end, allow us to recommend a new op-ed in the Journal of Life Sciences, "Strange Bedfellows."
Here's a taste:
"The politics of healthcare make strange bedfellows. Nearly 15 years ago, most health insurance plans opposed Hillary Clinton when she tried to give American healthcare a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton plan as government takeover of medical decision-making based on cost considerations.
Last month, the presidential hopeful and the insurers stood shoulder-to-shoulder in support of giving the federal government the same power government agencies in single-payer systems have to determine what new medicines and services to pay for or not, based on what a government agency decides are cost-effective. In essence, both Clinton and the health care lobby want the government to engage in the practice of medicine.
What's changed? Clinton has always regarded government as the best arbiter of value for medicine. Health plans, now that they have a stake in Medicare, want the government to make across-the-board decisions about reimbursement. Now the Medicare Payment Advisory Commission, the independent federal body established to advise Congress on issues affecting Medicare, has endorsed a specific approach. It wants an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers and public and private payers.
The model, believe it or not, is Britain's National Institute for Clinical Excellence, which reviews comparative effectiveness of new and often expensive medicines in the way the Medicare Payment Advisory Commission and Senator Clinton envision. Steven Pearson, a senior fellow with the insurance industry lobbying group America's Health Insurance Plans, thinks that the British approach is an example of leadership and courage. As such, it's worth looking at the decision process our nation should follow in deciding how, whether and in what circumstances it will pay for a medicine."
Here's a link to the entire article:
http://cmpi.org/archives/2007/07/strange_bedfellows.php
And for those of you who like to read ahead, here's the article's concluding paragraph:
"Personalized medicine gives doctors and patients control over healthcare decisions while comparative effectiveness, as it is now defined, will increase government control over the choices doctors and patients make in the future. The battle over the value of medicine and who decides what is valuable will determine who controls healthcare in America over the next decade. That explains why Clinton and the insurance lobby are allies in the effort to give government more control over these important choices in the years ahead."
To that end, allow us to recommend a new op-ed in the Journal of Life Sciences, "Strange Bedfellows."
Here's a taste:
"The politics of healthcare make strange bedfellows. Nearly 15 years ago, most health insurance plans opposed Hillary Clinton when she tried to give American healthcare a makeover in the image of the European and Canadian system. Back then, insurers blasted the Clinton plan as government takeover of medical decision-making based on cost considerations.
Last month, the presidential hopeful and the insurers stood shoulder-to-shoulder in support of giving the federal government the same power government agencies in single-payer systems have to determine what new medicines and services to pay for or not, based on what a government agency decides are cost-effective. In essence, both Clinton and the health care lobby want the government to engage in the practice of medicine.
What's changed? Clinton has always regarded government as the best arbiter of value for medicine. Health plans, now that they have a stake in Medicare, want the government to make across-the-board decisions about reimbursement. Now the Medicare Payment Advisory Commission, the independent federal body established to advise Congress on issues affecting Medicare, has endorsed a specific approach. It wants an independent entity to sponsor credible research on comparative effectiveness of health care services and disseminate this information to patients, providers and public and private payers.
The model, believe it or not, is Britain's National Institute for Clinical Excellence, which reviews comparative effectiveness of new and often expensive medicines in the way the Medicare Payment Advisory Commission and Senator Clinton envision. Steven Pearson, a senior fellow with the insurance industry lobbying group America's Health Insurance Plans, thinks that the British approach is an example of leadership and courage. As such, it's worth looking at the decision process our nation should follow in deciding how, whether and in what circumstances it will pay for a medicine."
Here's a link to the entire article:
http://cmpi.org/archives/2007/07/strange_bedfellows.php
And for those of you who like to read ahead, here's the article's concluding paragraph:
"Personalized medicine gives doctors and patients control over healthcare decisions while comparative effectiveness, as it is now defined, will increase government control over the choices doctors and patients make in the future. The battle over the value of medicine and who decides what is valuable will determine who controls healthcare in America over the next decade. That explains why Clinton and the insurance lobby are allies in the effort to give government more control over these important choices in the years ahead."
You cannot escape the responsibility of tomorrow by evading it today.
-- Abraham Lincoln
When the government issues health care statistics there are usually two general responses from the constituencies that are influenced – “this shows a problem,†or “the study is flawed.†And what ensues is a blame game, a political, polemical battle of op-eds and spin. What rarely happens is that all sides consider the implications of the numbers and use them to advance the public health. There are many examples of this, perhaps the best known being the debate over the Part D drug benefit.
But a new study, just released by the Center for Medicare and Medicaid Services (CMS), is breaking the mold. And it’s about time. The report, based data on Medicare patients who died from heart failure between July 2005 and June 2006, ranks hospitals as to whether they fall above or below the average and the results are available and searchable on a federal Web site (www.hospitalcompare.hhs.gov) that compares mortality rates among the nation's more than 4,000 medical facilities.
Needless to say, those scoring well crowed and those falling below the national average started the spin cycle. Examples were not hard to find – that’s not news. What is important to discuss, on the other hand, is how some hospitals dealt with their below-average ranking. As I searched through the CMS database, I was surprised to find Baylor All Saints Medical Centers at Fort Worth Texas on the “below average†side. Having followed Baylor Health Care System over the years for a variety of reasons, I decided to look a little closer.
Here's the rest of the story:
Download file
The take-away?
"... if we want people to take more responsibility for their own health – those in the business of health care must as well. Do as I say, not as I do just doesn’t cut it when it comes to advancing America’s health."
The price of greatness is responsibility.
-- Winston Churchill
-- Abraham Lincoln
When the government issues health care statistics there are usually two general responses from the constituencies that are influenced – “this shows a problem,†or “the study is flawed.†And what ensues is a blame game, a political, polemical battle of op-eds and spin. What rarely happens is that all sides consider the implications of the numbers and use them to advance the public health. There are many examples of this, perhaps the best known being the debate over the Part D drug benefit.
But a new study, just released by the Center for Medicare and Medicaid Services (CMS), is breaking the mold. And it’s about time. The report, based data on Medicare patients who died from heart failure between July 2005 and June 2006, ranks hospitals as to whether they fall above or below the average and the results are available and searchable on a federal Web site (www.hospitalcompare.hhs.gov) that compares mortality rates among the nation's more than 4,000 medical facilities.
Needless to say, those scoring well crowed and those falling below the national average started the spin cycle. Examples were not hard to find – that’s not news. What is important to discuss, on the other hand, is how some hospitals dealt with their below-average ranking. As I searched through the CMS database, I was surprised to find Baylor All Saints Medical Centers at Fort Worth Texas on the “below average†side. Having followed Baylor Health Care System over the years for a variety of reasons, I decided to look a little closer.
Here's the rest of the story:
Download file
The take-away?
"... if we want people to take more responsibility for their own health – those in the business of health care must as well. Do as I say, not as I do just doesn’t cut it when it comes to advancing America’s health."
The price of greatness is responsibility.
-- Winston Churchill
Since Michael Moore regards Al Qaida as a bunch of freedom fighters this story from Britain's Daily Mail about the UK terrorists should make him and drugwonks "friends" in the blog world giddy with delight...
"Terror ringleader' is brilliant NHS doctor
An Iraqi junior doctor and a brilliant neurologist working for the NHS are among the suspects being quizzed over the series of bomb attacks across Britain, it emerged today."
And oh yes, there was a controlled explosion carried out at the Royal Alexandra Hospital.
Our prayers and thoughts are with the citizens of the UK.....
Read here
"Terror ringleader' is brilliant NHS doctor
An Iraqi junior doctor and a brilliant neurologist working for the NHS are among the suspects being quizzed over the series of bomb attacks across Britain, it emerged today."
And oh yes, there was a controlled explosion carried out at the Royal Alexandra Hospital.
Our prayers and thoughts are with the citizens of the UK.....
Read here
The NY Times has a editorial today supporting a government registry that would require drug companies to report all gifts it gives to doctors that might be construed as influencing their prescribing behavior. Here's the justification the Times editorial board gives for supporting this intrusion into the privacy of doctor's lives:
"As Gardiner Harris reported in The Times last week, one drug company invited doctors to a weekend training session in Orlando, Fla., to learn how to give marketing lectures to other doctors for an asthma medicine. The enticement was free airfare, a rental car and hotel room, plus a $2,700 stipend."
Enticement? How about covering travel expenses and professional time. As for the allegation that docs were "influenced". Where is the data and where is the evidence of patient harm.
Since Americans now get their information on health from major media outlets I would propose another registry: A list of all reporters who get bonuses for writing articles that "break" stories that affect people's perception of public health institutions or drug safety. It would be wrong, wrong, wrong for the New York Times or any paper to reward a reporter with a cash bonus for writing an article just because it caused a ruckus on public health matters, say for instance, an article about the financial ties of the advisory committees for the FDA. I mean a financial reward for an article on financial ties shaping decisions. I mean that would be so hypocritical as to be....ironic.
The Times should just clean it's own house or tend to it's own garden.
http://www.nytimes.com/2007/07/02/opinion/02mon2.html?_r=1&oref=slogin
"As Gardiner Harris reported in The Times last week, one drug company invited doctors to a weekend training session in Orlando, Fla., to learn how to give marketing lectures to other doctors for an asthma medicine. The enticement was free airfare, a rental car and hotel room, plus a $2,700 stipend."
Enticement? How about covering travel expenses and professional time. As for the allegation that docs were "influenced". Where is the data and where is the evidence of patient harm.
Since Americans now get their information on health from major media outlets I would propose another registry: A list of all reporters who get bonuses for writing articles that "break" stories that affect people's perception of public health institutions or drug safety. It would be wrong, wrong, wrong for the New York Times or any paper to reward a reporter with a cash bonus for writing an article just because it caused a ruckus on public health matters, say for instance, an article about the financial ties of the advisory committees for the FDA. I mean a financial reward for an article on financial ties shaping decisions. I mean that would be so hypocritical as to be....ironic.
The Times should just clean it's own house or tend to it's own garden.
http://www.nytimes.com/2007/07/02/opinion/02mon2.html?_r=1&oref=slogin
Here's MedPac's upbeat message on how evidence based medicine will revolutionize health care. It will lead to
"[increased] federal administrative spending relative to current law" due to "increasing the capacity to examine the comparative effectiveness of health care services," and "[improved] decision making by patients, providers, and payers" due to "information on the comparative effectiveness of health care services."
Cut to the Subcommittee on Health of the House Committee on Ways and Means hearing on developing a new reimbursement system for Erythropoiesis-stimulating Agents (ESAs), for a reality check. In particular, the statement of Alan S. Kliger, M.D., President, Renal Physicians Association, Rockville, Maryland on "Variability in ESRD Patient Hemoglobin Levels"
"Recent studies warn that kidney failure patients should not have high blood counts, noting that a group of patients with high blood counts in general carried a higher risk than patients with lower blood counts. But my experience with one of my patients shows how patient-centered care sometimes should deviate from guideline-advised care. I have a 52-year-old patient who is in kidney failure. When his blood count is less than 36 percent, he feels tired and washed out and experiences chest pain. When EPO raises his blood count to 38 percent, he feels like a healthy man; he functions better and feels more productive. The differences are so prominent to him that he tells me what his blood count is before I have a chance to measure it. For this particular patient, a higher blood count is what he needs in order to function normally. My patient knows that the recent studies warn about the long-term side effects of these higher blood counts, but he also knows he needs these levels to function normally. His choice and mine for enough EPO to maintain higher blood counts is the right choice.
RPA believes that in the recent discourse on national coverage of EPO, the critical issue of variability of individual patient response to EPO dose has been understated. As we have noted in correspondence to CMS, attempts to assess or quantify individual sensitivities (i.e. responsiveness) to EPO at a narrow level have not been successful.
Therefore, there is no single, predictable response to a given dose of EPO, a fact that accounts for the wide range in individual responses to treatment. As a result, in the aggregate it is physiologically not rational to tailor a normal distribution of patient responses to a payment limit: such a paradigm cannot be successful in delivering optimal treatment with sophisticated agents to complicated patients.
Payment limits structured in this fashion place emphasis on the wrong arm of therapy: emphasis should be placed rather on reducing the number of patients with low hematocrits/hemoglobins (<30%/10 gm/dL). "
http://waysandmeans.house.gov/hearings.asp?formmode=detail&hearing=573
MedPAC and the rest of the comparative effectiveness club are ignoring the human consequences of one size fits all decisions such as these or the denial of cancer and Alzheimer's care in the UK, Canada, Australia. The focus is on the structure of the center, the funding, furniture, color schemes, resumes, etc.
The comparative effectiveness movement will, like the Clinton health plan, be undone, by it's arrogance, high-handedness and contempt for the doctor-patient relationship.
"[increased] federal administrative spending relative to current law" due to "increasing the capacity to examine the comparative effectiveness of health care services," and "[improved] decision making by patients, providers, and payers" due to "information on the comparative effectiveness of health care services."
Cut to the Subcommittee on Health of the House Committee on Ways and Means hearing on developing a new reimbursement system for Erythropoiesis-stimulating Agents (ESAs), for a reality check. In particular, the statement of Alan S. Kliger, M.D., President, Renal Physicians Association, Rockville, Maryland on "Variability in ESRD Patient Hemoglobin Levels"
"Recent studies warn that kidney failure patients should not have high blood counts, noting that a group of patients with high blood counts in general carried a higher risk than patients with lower blood counts. But my experience with one of my patients shows how patient-centered care sometimes should deviate from guideline-advised care. I have a 52-year-old patient who is in kidney failure. When his blood count is less than 36 percent, he feels tired and washed out and experiences chest pain. When EPO raises his blood count to 38 percent, he feels like a healthy man; he functions better and feels more productive. The differences are so prominent to him that he tells me what his blood count is before I have a chance to measure it. For this particular patient, a higher blood count is what he needs in order to function normally. My patient knows that the recent studies warn about the long-term side effects of these higher blood counts, but he also knows he needs these levels to function normally. His choice and mine for enough EPO to maintain higher blood counts is the right choice.
RPA believes that in the recent discourse on national coverage of EPO, the critical issue of variability of individual patient response to EPO dose has been understated. As we have noted in correspondence to CMS, attempts to assess or quantify individual sensitivities (i.e. responsiveness) to EPO at a narrow level have not been successful.
Therefore, there is no single, predictable response to a given dose of EPO, a fact that accounts for the wide range in individual responses to treatment. As a result, in the aggregate it is physiologically not rational to tailor a normal distribution of patient responses to a payment limit: such a paradigm cannot be successful in delivering optimal treatment with sophisticated agents to complicated patients.
Payment limits structured in this fashion place emphasis on the wrong arm of therapy: emphasis should be placed rather on reducing the number of patients with low hematocrits/hemoglobins (<30%/10 gm/dL). "
http://waysandmeans.house.gov/hearings.asp?formmode=detail&hearing=573
MedPAC and the rest of the comparative effectiveness club are ignoring the human consequences of one size fits all decisions such as these or the denial of cancer and Alzheimer's care in the UK, Canada, Australia. The focus is on the structure of the center, the funding, furniture, color schemes, resumes, etc.
The comparative effectiveness movement will, like the Clinton health plan, be undone, by it's arrogance, high-handedness and contempt for the doctor-patient relationship.
Does that headline look familiar? Of course, you see it all the time in headlines about "new poll findings." But, as any savvy drugwonk knows, you can get any answer you want depending on how you ask the question.
So we decided to see what some New Yorkers know -- or think they know -- about a couple of health care issues in our latest podcast.
Have a look:
http://cmpi.org/archives/2007/06/what_do_people_really_know_abo.php
If you have questions that you'd like us to ask in our next podcast, please send them along by commenting via this blog.
So we decided to see what some New Yorkers know -- or think they know -- about a couple of health care issues in our latest podcast.
Have a look:
http://cmpi.org/archives/2007/06/what_do_people_really_know_abo.php
If you have questions that you'd like us to ask in our next podcast, please send them along by commenting via this blog.
“All animals are equal, but some animals are more equal than others.†A famous line from a famous book with a famous lesson – they’re not.
Today that lesson needs to be relearned. Case-in-point, a Canadian judge’s apparent belief that all patents are equal, but some patents are less equal than others.
Specifically, pharmaceutical patents.
But first a point of order – this is not about the position of the Government of Canada, which is very good on these issues. This is about the actions of an activist judge – the Honourable Mr. Justice Hughes, of the Federal Court of Canada.
It’s about a patent case brought by Novopharm (the large Canadian generics company) against Eli Lilly (the large American pharmaceutical company). But the issue is considerably broader and the precedent is frightening not only for innovator pharmaceutical firms – but for the future of Canadian public health.
The issue, relative to a pharmaceutical patent, “… is the sufficiency of the disclosure in the patent itself…†Judge Hughes’ decision has created a requirement that “… the advantage must be plainly and fully set out in sufficient detail so as to enable a person skilled in the art to know and appreciate what they are.†That is, the judge found that it is “mere rhetoric†to only state the advantages of the invention in the patent specification.
And get this – Judge Hughes ruled on an argument that wasn’t even made by Novopharm. He invented and then ruled on his own argument.
Here's a link to Judge Hughes’ June 5, 2007 decision:
http://decisions.fct-cf.gc.ca/en/2007/2007fc596/2007fc596.html
(PS/ A Canadian appellate court chastised Judge Hughes' decision.)
A couple of crucial points:
Eli Lilly Canada Inc. v. Novopharm Limited raises a significant new question of law and represents a significant shift in the requirement for disclosure in patent applications that has an immediate impact on presently pending applications and patents-in-force in Canada.
Judge Hughes’ ruling is out of step with Canadian law; it violates international IP treaties (TRIPS, PCT), and makes Canada an outlier among all developed and developing countries.
For example, the Patent Cooperation Treaty (PCT) provides for the requirements of a patent specification and states that the “description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art.†Considering that Canada is a member of the PCT, it seems that the Federal Court has now made Canada non-compliant with its treaty obligations.
Furthermore, by applying this “super-sufficiency†requirement to a certain class of improvement patents (so-called “selection†patents); the decision also violates the nondiscrimination clauses of TRIPS. TRIPS requires that the standards of patentability for all technology must be the same. In addition, by applying this requirement only to selection patents, the legal requirements in Canada now improperly establish a higher standard of patentability for this type of innovation in contravention of the non-discriminatory clauses of TRIPS.
And, even worse, the Court of Appeals in Canada has created a practice of dismissing any adverse ruling against the pharmaceutical patent as being moot if the generic obtains its marketing approval before the appeal can be heard. So, a generic challenger has their day in court and a full opportunity to appeal a ruling. The innovator pharmaceutical company has their day in court with the first challenger and if there is an adverse ruling will have no opportunity to appeal. To further exacerbate matters, the Court of Appeals has also held that once the first generic challenger has prevailed subsequent challengers should also be granted an approval.
So much for checks and balances.
These actions are manifestly unfair to the research-based pharmaceutical industry and will chill pharmaceutical innovation in the Great White North. This illegal and unfair attitude, if it continues unfettered or unquestioned, will lead to fewer innovative pharmaceutical products being made available to Canadians.
Ah, those pesky unintended consequences.
Today that lesson needs to be relearned. Case-in-point, a Canadian judge’s apparent belief that all patents are equal, but some patents are less equal than others.
Specifically, pharmaceutical patents.
But first a point of order – this is not about the position of the Government of Canada, which is very good on these issues. This is about the actions of an activist judge – the Honourable Mr. Justice Hughes, of the Federal Court of Canada.
It’s about a patent case brought by Novopharm (the large Canadian generics company) against Eli Lilly (the large American pharmaceutical company). But the issue is considerably broader and the precedent is frightening not only for innovator pharmaceutical firms – but for the future of Canadian public health.
The issue, relative to a pharmaceutical patent, “… is the sufficiency of the disclosure in the patent itself…†Judge Hughes’ decision has created a requirement that “… the advantage must be plainly and fully set out in sufficient detail so as to enable a person skilled in the art to know and appreciate what they are.†That is, the judge found that it is “mere rhetoric†to only state the advantages of the invention in the patent specification.
And get this – Judge Hughes ruled on an argument that wasn’t even made by Novopharm. He invented and then ruled on his own argument.
Here's a link to Judge Hughes’ June 5, 2007 decision:
http://decisions.fct-cf.gc.ca/en/2007/2007fc596/2007fc596.html
(PS/ A Canadian appellate court chastised Judge Hughes' decision.)
A couple of crucial points:
Eli Lilly Canada Inc. v. Novopharm Limited raises a significant new question of law and represents a significant shift in the requirement for disclosure in patent applications that has an immediate impact on presently pending applications and patents-in-force in Canada.
Judge Hughes’ ruling is out of step with Canadian law; it violates international IP treaties (TRIPS, PCT), and makes Canada an outlier among all developed and developing countries.
For example, the Patent Cooperation Treaty (PCT) provides for the requirements of a patent specification and states that the “description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art.†Considering that Canada is a member of the PCT, it seems that the Federal Court has now made Canada non-compliant with its treaty obligations.
Furthermore, by applying this “super-sufficiency†requirement to a certain class of improvement patents (so-called “selection†patents); the decision also violates the nondiscrimination clauses of TRIPS. TRIPS requires that the standards of patentability for all technology must be the same. In addition, by applying this requirement only to selection patents, the legal requirements in Canada now improperly establish a higher standard of patentability for this type of innovation in contravention of the non-discriminatory clauses of TRIPS.
And, even worse, the Court of Appeals in Canada has created a practice of dismissing any adverse ruling against the pharmaceutical patent as being moot if the generic obtains its marketing approval before the appeal can be heard. So, a generic challenger has their day in court and a full opportunity to appeal a ruling. The innovator pharmaceutical company has their day in court with the first challenger and if there is an adverse ruling will have no opportunity to appeal. To further exacerbate matters, the Court of Appeals has also held that once the first generic challenger has prevailed subsequent challengers should also be granted an approval.
So much for checks and balances.
These actions are manifestly unfair to the research-based pharmaceutical industry and will chill pharmaceutical innovation in the Great White North. This illegal and unfair attitude, if it continues unfettered or unquestioned, will lead to fewer innovative pharmaceutical products being made available to Canadians.
Ah, those pesky unintended consequences.
Whichever party wins the White House in 2008, one truth will prevail at FDA – regulators love ambiguity but can learn to embrace predictability.
A second truth is that FDA decisions are and will continue to be based solely on sound science and its impact on the public health. So, whether red or blue is ascendant, FDA will make its decisions based on the facts.
What might change, depending on who occupies the White House and the FDA Commissioner’s Office, is how the FDA views the concept of time. And it could go either way --because there is real time and there’s FDA time.
There’s an old Washington story that goes like this -- Henry Kissinger asked Chinese leader Chou En Lai whether the French Revolution of 1789 had benefited humanity, to which Chou responded: "It's too early to tell."
Chou would have made a great regulator.
Real time is for the world we live in. The clock we watch – for business, certainly, but also for the rest of us. FDA time is the time it takes to get it right (PDUFA notwithstanding) and, unless there's a trebling of the FDA budget, the only real way to meaningfully accelerate FDA actions without compromising quality (read “safety and effectivenessâ€) is through collaboration with academe, with industry, and with hybrids like Ray Woosley's Critical Path Initiative.
Will collaboration continue to be embraced by the next President? By the next FDA Commissioner? This is the crucial question.
A related core issue is predictability – the opposite of ambiguity.
Predictability is power in pursuit of the public health. A case in point is the Critical Path initiative and the ways it can reach out and work with non-government partners via the imminent Reagan-Udall Center (pending in still pensile legislation). But ambiguity is bureaucratic power – and too many regulators accept ambiguity as a replacement for responsibility..
(I also believe that too many folks at pharmaceutical companies accept ambiguity as a replacement for responsibility.)
The coming election, relative to the future of the FDA, is a battle between nascent predictability and insidious ambiguity. So, here’s my idea for a bumper-sticker – “I support the FDA and I vote.â€
A second truth is that FDA decisions are and will continue to be based solely on sound science and its impact on the public health. So, whether red or blue is ascendant, FDA will make its decisions based on the facts.
What might change, depending on who occupies the White House and the FDA Commissioner’s Office, is how the FDA views the concept of time. And it could go either way --because there is real time and there’s FDA time.
There’s an old Washington story that goes like this -- Henry Kissinger asked Chinese leader Chou En Lai whether the French Revolution of 1789 had benefited humanity, to which Chou responded: "It's too early to tell."
Chou would have made a great regulator.
Real time is for the world we live in. The clock we watch – for business, certainly, but also for the rest of us. FDA time is the time it takes to get it right (PDUFA notwithstanding) and, unless there's a trebling of the FDA budget, the only real way to meaningfully accelerate FDA actions without compromising quality (read “safety and effectivenessâ€) is through collaboration with academe, with industry, and with hybrids like Ray Woosley's Critical Path Initiative.
Will collaboration continue to be embraced by the next President? By the next FDA Commissioner? This is the crucial question.
A related core issue is predictability – the opposite of ambiguity.
Predictability is power in pursuit of the public health. A case in point is the Critical Path initiative and the ways it can reach out and work with non-government partners via the imminent Reagan-Udall Center (pending in still pensile legislation). But ambiguity is bureaucratic power – and too many regulators accept ambiguity as a replacement for responsibility..
(I also believe that too many folks at pharmaceutical companies accept ambiguity as a replacement for responsibility.)
The coming election, relative to the future of the FDA, is a battle between nascent predictability and insidious ambiguity. So, here’s my idea for a bumper-sticker – “I support the FDA and I vote.â€
Someone with a twisted mind came up with this headline at CNN.com..
FDA bans import of drugged fish from China
Food and Drug Administration announced a ban on the import of five species of seafood from China due to possible contamination with medications.
http://http://money.cnn.com/2007/06/28/news/international/china_fish/?postversion=2007062815
FDA bans import of drugged fish from China
Food and Drug Administration announced a ban on the import of five species of seafood from China due to possible contamination with medications.
http://http://money.cnn.com/2007/06/28/news/international/china_fish/?postversion=2007062815
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