Latest Drugwonks' Blog
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
You have to love the way the NEJM and the NY Times treat the issue of drug safety. Steve Nissen runs a crappy meta-analysis of Avandia's supposed dangers and it's rushed to e-print in advance of a Senate hearing and the close of the markets. The NYTmakes it front page news.
A careful study that shows a very low risk of birth defects among women taking anti-depressants while pregnant...? Why, the very same NEJM sees no reason to stop the presses. No Congressional hearings. No publicity whores running to Nightline to talk about the number of suicides and depressed women who affected by the lack of treatment.
And the NY Times? No front page articles linking anti-depressants to "suicides." Because this time it's for real and this time it's a case of telling pregnant women it's ok to take them. (Kudos to http:// pharmalot.com for being one of the first on the web with the good news)
It's page A16, next to a silly story about a congressional proposal setting up a mandatory registry of all "gifts" drug companies provide to doctors. Listen to how the NY Times reports on this NEJM article:
The findings, appearing in two studies in The New England Journal of Medicine, support doctors’ assurances that antidepressants are not a major cause of serious physical problems in newborns.
"But the studies did not include enough cases to adequately assess risk of many rare defects; nor did they include information on how long women were taking antidepressants or at what doses. The studies did not evaluate behavioral effects either; previous research has found that babies suffer withdrawal effects if they have been exposed to antidepressants in the womb, and that may have implications for later behavior.
“These are important papers, but they don’t close the questions of whether there are major effects†of these drugs on developing babies, said Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, who was not involved in the studies. “There are many more chapters in this story yet to be told.â€
http://www.nytimes.com/2007/06/28/health/28depress.html?_r=1&oref=slogin
Meanwhile, in responding to a similar study last year Oberlander said: "At present, probably the effect of not treating the women's clinical depression is a much bigger issue for mothers and their infants."
http://www.healthfinder.gov/news/newsstory.asp?docid=530794
Maybe we should do a study looking at the effect of being interviewed by the NYT on the quotes researchers give to reporters. We could call it the Nissen Doomsday Effect.
I digress. Notice all the caveats? Now here's the NYT on Avandia:
"The analysis, based on a review of more than 40 existing clinical studies involving nearly 28,000 patients, showed that Avandia significantly increased the risk of heart attacks, compared with other diabetes drugs or a placebo.
Both the study’s lead author and the editors of The New England Journal of Medicine, in which the article appeared, cautioned that the research method used left the findings open to interpretation. But they said the study nevertheless raised important concerns.
And the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.
The journal’s editor in chief, Dr. Jeffrey M. Drazen, said: “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.â€
http://www.nytimes.com/2007/05/22/business/22drug.html?pagewanted=1&ei=5070&en=dacbc8e498ef3c7d&ex=1183176000
No bias in the media on drug safety. None at all. In light of the increase in teen suicide due to a decline in SSRI use which was triggered by biased reporting, makes you wonder what would happen if drug companies weren't around to provide responsible, peer-reviewed and regulated information about the benefits of their products. And I AM serious about that.
A careful study that shows a very low risk of birth defects among women taking anti-depressants while pregnant...? Why, the very same NEJM sees no reason to stop the presses. No Congressional hearings. No publicity whores running to Nightline to talk about the number of suicides and depressed women who affected by the lack of treatment.
And the NY Times? No front page articles linking anti-depressants to "suicides." Because this time it's for real and this time it's a case of telling pregnant women it's ok to take them. (Kudos to http:// pharmalot.com for being one of the first on the web with the good news)
It's page A16, next to a silly story about a congressional proposal setting up a mandatory registry of all "gifts" drug companies provide to doctors. Listen to how the NY Times reports on this NEJM article:
The findings, appearing in two studies in The New England Journal of Medicine, support doctors’ assurances that antidepressants are not a major cause of serious physical problems in newborns.
"But the studies did not include enough cases to adequately assess risk of many rare defects; nor did they include information on how long women were taking antidepressants or at what doses. The studies did not evaluate behavioral effects either; previous research has found that babies suffer withdrawal effects if they have been exposed to antidepressants in the womb, and that may have implications for later behavior.
“These are important papers, but they don’t close the questions of whether there are major effects†of these drugs on developing babies, said Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, who was not involved in the studies. “There are many more chapters in this story yet to be told.â€
http://www.nytimes.com/2007/06/28/health/28depress.html?_r=1&oref=slogin
Meanwhile, in responding to a similar study last year Oberlander said: "At present, probably the effect of not treating the women's clinical depression is a much bigger issue for mothers and their infants."
http://www.healthfinder.gov/news/newsstory.asp?docid=530794
Maybe we should do a study looking at the effect of being interviewed by the NYT on the quotes researchers give to reporters. We could call it the Nissen Doomsday Effect.
I digress. Notice all the caveats? Now here's the NYT on Avandia:
"The analysis, based on a review of more than 40 existing clinical studies involving nearly 28,000 patients, showed that Avandia significantly increased the risk of heart attacks, compared with other diabetes drugs or a placebo.
Both the study’s lead author and the editors of The New England Journal of Medicine, in which the article appeared, cautioned that the research method used left the findings open to interpretation. But they said the study nevertheless raised important concerns.
And the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.
The journal’s editor in chief, Dr. Jeffrey M. Drazen, said: “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.â€
http://www.nytimes.com/2007/05/22/business/22drug.html?pagewanted=1&ei=5070&en=dacbc8e498ef3c7d&ex=1183176000
No bias in the media on drug safety. None at all. In light of the increase in teen suicide due to a decline in SSRI use which was triggered by biased reporting, makes you wonder what would happen if drug companies weren't around to provide responsible, peer-reviewed and regulated information about the benefits of their products. And I AM serious about that.
Lest anyone be uncertain that Peter Rost is not a small-minded person who blogs without regard to the totality of the facts, here is the context of Rost's gleeful pursuit of Pfizer's renewed effort to market Viracept, an "old drug" as the consistently vindictive and inaccurate Rost calls the HIV medicine.
Pfizer, according to Rost, was quick to launch marketing materials regarding Viracept. It's materials were not issued and released INTERNALLY consisted with it's own guidelines and the release was shut down. Therefore Rost cannot contain his glee at the expense of the former employe whom he drew a no-show salary from to the tune of over $600K a year while suing them.
But here are some relevant facts, perhaps, just perhaps.
1. The World Health Organization (WHO), drug companies, drug regulators, NGOs and national governments have been working together to minimise the disruption of antiretroviral therapy to individuals affected by the near-global recall of nelfinavir (Viracept).
Although it was initially thought that the recall only affected Europe following the alerts issued by Roche, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMEA) on June 6 th, it has, in fact, affected every country in the world with the exception of the United States and its territories, Canada and Japan.
"A very difficult situation"
On June 14th, WHO issued a statement on the recall, saying that "Roche informed WHO on 8 June 2007 of its global recall of its nelfinavir products (Viracept)." Roche estimates that around 45,000 individuals are affected by the recall globally.
Roche’s International Communications Manager for HIV and Hepatitis, Janet Kettels told aidsmap.com: "This is obviously a very difficult situation, as many people living with HIV/AIDS in the least developed countries do not have easy access to a wide range of alternative treatments."
http://www.aidsmap.com/en/news/EFA4601B-2827-4131-B2E8-6EB722BEE1D9.asp
2. Roche is in Talks With Pfizer Over Viracept Supply Following Recall
As Roche corrects a manufacturing error that resulted in a recall of all batches of its HIV treatment Viracept sold in the European Union (EU) and other world markets, the company is in discussions with Pfizer to supply the antiretroviral as a potential option in expediting the market return of the product, Roche told DID June 20.
www.aidsmap.com
Here's a link to the sludge report.... http://peterrost.blogspot.com/
Pfizer, according to Rost, was quick to launch marketing materials regarding Viracept. It's materials were not issued and released INTERNALLY consisted with it's own guidelines and the release was shut down. Therefore Rost cannot contain his glee at the expense of the former employe whom he drew a no-show salary from to the tune of over $600K a year while suing them.
But here are some relevant facts, perhaps, just perhaps.
1. The World Health Organization (WHO), drug companies, drug regulators, NGOs and national governments have been working together to minimise the disruption of antiretroviral therapy to individuals affected by the near-global recall of nelfinavir (Viracept).
Although it was initially thought that the recall only affected Europe following the alerts issued by Roche, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMEA) on June 6 th, it has, in fact, affected every country in the world with the exception of the United States and its territories, Canada and Japan.
"A very difficult situation"
On June 14th, WHO issued a statement on the recall, saying that "Roche informed WHO on 8 June 2007 of its global recall of its nelfinavir products (Viracept)." Roche estimates that around 45,000 individuals are affected by the recall globally.
Roche’s International Communications Manager for HIV and Hepatitis, Janet Kettels told aidsmap.com: "This is obviously a very difficult situation, as many people living with HIV/AIDS in the least developed countries do not have easy access to a wide range of alternative treatments."
http://www.aidsmap.com/en/news/EFA4601B-2827-4131-B2E8-6EB722BEE1D9.asp
2. Roche is in Talks With Pfizer Over Viracept Supply Following Recall
As Roche corrects a manufacturing error that resulted in a recall of all batches of its HIV treatment Viracept sold in the European Union (EU) and other world markets, the company is in discussions with Pfizer to supply the antiretroviral as a potential option in expediting the market return of the product, Roche told DID June 20.
www.aidsmap.com
Here's a link to the sludge report.... http://peterrost.blogspot.com/
Two interesting stories today that both reach the same place -- we need to find ways to get the right medicines to the right people at the right time in the right dose. Let's call it "Pharmonic Convergence."
First story comes from the Pink Sheet and their discussion of FDA's genetic test guidelines.
As reporter David Filmore writes vis-a-vis the FDA's genetic test guidelines:
"The agency drafted the guidance document on pharmacogenetic tests and genetic tests for heritable markers to help shorten development and review times for these products, which are attracting growing attention from the medical community as tools to make more precise disgnoses and, in the case of pharmacogenetic tests, more personalized treatment decisions."
Right now, today such tests exist. It is not, as many will derisively tell you, science fiction. It's science fact. And the fact that most insurance companies don't reimburse for such diagnistic tools is short sighted.
To that point, an article from today's New York Times. Gray Lady scribe Milt Freudenheim reports on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."
"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.
As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."
The lede of the New York Times article reads, "Health penny wise, medical pound foolish?
Indeed.
Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payors interpose themselves between doctor and patient, when prescribing decisions are made by accountants (read "evidence-based medicine"), health outcomes decline for the individual and costs go up for the payor.
Let's keep our eye on the prize as we strive to move from acute to a chronic care model for 21st century health care. It's nothing short of critical.
And, after all, that's why we have the Critical Path.
First story comes from the Pink Sheet and their discussion of FDA's genetic test guidelines.
As reporter David Filmore writes vis-a-vis the FDA's genetic test guidelines:
"The agency drafted the guidance document on pharmacogenetic tests and genetic tests for heritable markers to help shorten development and review times for these products, which are attracting growing attention from the medical community as tools to make more precise disgnoses and, in the case of pharmacogenetic tests, more personalized treatment decisions."
Right now, today such tests exist. It is not, as many will derisively tell you, science fiction. It's science fact. And the fact that most insurance companies don't reimburse for such diagnistic tools is short sighted.
To that point, an article from today's New York Times. Gray Lady scribe Milt Freudenheim reports on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."
"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.
As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."
The lede of the New York Times article reads, "Health penny wise, medical pound foolish?
Indeed.
Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payors interpose themselves between doctor and patient, when prescribing decisions are made by accountants (read "evidence-based medicine"), health outcomes decline for the individual and costs go up for the payor.
Let's keep our eye on the prize as we strive to move from acute to a chronic care model for 21st century health care. It's nothing short of critical.
And, after all, that's why we have the Critical Path.
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.
