Latest Drugwonks' Blog
Which of these is likely to be the per client amount individuals who entered the Vioxx litigation sweepstakes are going to get:
a. $1million
b. $400k
c. $75000
d. $5300
If you picked d) you get a tube of John Edwards' hair gel. That's right. Take the $4.8 billion Merck will fork over, give half of it to all those well meaning trial attorneys and then divide the rest among the 45000 plaintiffs.
CORRECTION: My friend, and consigliere Paul Windels nails me on the math, my estimate of the tort take and my cheap calculator that only runs into the hundreds of milions and wins a case of hair grout with the following email...
Bob -- I think you have a decimal point error here. If there are 45,000 plaintiffs, $5,000 per plaintiff is around 225 million. Your number is correct if there are 450,000 plaintiffs -- on the other hand any plaintiff with a decent case would opt out of the settlement if it were only worth $5,300. I would expect a fee max 33% meaning $3.2 billion net, which would be around $70K per, a much more attractive number. Cheers. Paul.
Did Merck ignore safety signals of Vioxx in a way that made it liable for people dying. No. There are lots of safety signals. Are there better ways to figure out which ones reflect real risk. You bet and that means not having to wait four years to find out about them, which was the point of Eric Topol's original article about Vioxx. Are we any closer to knowing how to manage the risks of COX-2s because of the grandstanding and litigation? No. Could Vioxx been remarketed and sold with tighter restrictions in a saner, less politicized environment. Yes. What will help patients more, better monitoring of risks and benefits of meds post market using 21st century science or a system gripped by fear and controlled by trial lawyers and self proclaimed consumer advocates who dredge data for danger?
On a lighter front, Crestor just got a label for atherosclerosis, a label which simvastatin generic Zocor, Stephanie Saul's drug of choice does not have. Simvastatin also seems to cause sleep problems in some patients which I am surprised Stephanie didn't know about since she is the NYT in house expert on sleep.
I hearken back to her article about Pfizer trying to maintain market share in the face of simvastatin competition and the firm trying to use the fact that patients respond differently to different drugs as a way to keep more people on Lipitor if its good for them in the long run. How about this as a proposition: not what's cheapest, but what is best and has the fewest side effects given our specific health needs. As we move towards personalized medicine those will be the claims that count. Or is that marketing too? In a politicized environment our choice is as follows: A drug that is marketed by drug companies is bad even if it is personalized. A drug dispensed according the musings ofJerry Avorn or some researcher who ignores individual differences in drug response to justify the cheapest (the Soros funded approach of the Institute for Medicine as Profession)..that's great.
a. $1million
b. $400k
c. $75000
d. $5300
If you picked d) you get a tube of John Edwards' hair gel. That's right. Take the $4.8 billion Merck will fork over, give half of it to all those well meaning trial attorneys and then divide the rest among the 45000 plaintiffs.
CORRECTION: My friend, and consigliere Paul Windels nails me on the math, my estimate of the tort take and my cheap calculator that only runs into the hundreds of milions and wins a case of hair grout with the following email...
Bob -- I think you have a decimal point error here. If there are 45,000 plaintiffs, $5,000 per plaintiff is around 225 million. Your number is correct if there are 450,000 plaintiffs -- on the other hand any plaintiff with a decent case would opt out of the settlement if it were only worth $5,300. I would expect a fee max 33% meaning $3.2 billion net, which would be around $70K per, a much more attractive number. Cheers. Paul.
Did Merck ignore safety signals of Vioxx in a way that made it liable for people dying. No. There are lots of safety signals. Are there better ways to figure out which ones reflect real risk. You bet and that means not having to wait four years to find out about them, which was the point of Eric Topol's original article about Vioxx. Are we any closer to knowing how to manage the risks of COX-2s because of the grandstanding and litigation? No. Could Vioxx been remarketed and sold with tighter restrictions in a saner, less politicized environment. Yes. What will help patients more, better monitoring of risks and benefits of meds post market using 21st century science or a system gripped by fear and controlled by trial lawyers and self proclaimed consumer advocates who dredge data for danger?
On a lighter front, Crestor just got a label for atherosclerosis, a label which simvastatin generic Zocor, Stephanie Saul's drug of choice does not have. Simvastatin also seems to cause sleep problems in some patients which I am surprised Stephanie didn't know about since she is the NYT in house expert on sleep.
I hearken back to her article about Pfizer trying to maintain market share in the face of simvastatin competition and the firm trying to use the fact that patients respond differently to different drugs as a way to keep more people on Lipitor if its good for them in the long run. How about this as a proposition: not what's cheapest, but what is best and has the fewest side effects given our specific health needs. As we move towards personalized medicine those will be the claims that count. Or is that marketing too? In a politicized environment our choice is as follows: A drug that is marketed by drug companies is bad even if it is personalized. A drug dispensed according the musings ofJerry Avorn or some researcher who ignores individual differences in drug response to justify the cheapest (the Soros funded approach of the Institute for Medicine as Profession)..that's great.
By now you will have surely have heard about Merck's $4.85 billion Vioxx settlement. That comes out to something more-or-less like $100,000 per plaintiff -- and not one cent for tribute to trial lawyers.
To paraphrase -- a billion here, a billion there and pretty soon you're talking about a settlement. My sources confirm that Merck had been spending about $1 billion a year on Vioxx litigation -- and, with no end in sight, $4.85 billion to make it go away is the smart fiduciary play.
That being said, it must stick in the craw of the folks at Merck to pony up this kind of do-re-mi for having done nothing wrong -- money that could (and should) have been spent on R&D.
If anything positive can come out of this travesty it's this -- Merck stood up for what it thought was right, won more than they lost -- and showed the trial bar, pundits, and pols that they weren't going to be doormats for cheap shots and SiCKO soundbites.
And that's a valuable lesson for the rest of the Big Pharma brethren.
To paraphrase -- a billion here, a billion there and pretty soon you're talking about a settlement. My sources confirm that Merck had been spending about $1 billion a year on Vioxx litigation -- and, with no end in sight, $4.85 billion to make it go away is the smart fiduciary play.
That being said, it must stick in the craw of the folks at Merck to pony up this kind of do-re-mi for having done nothing wrong -- money that could (and should) have been spent on R&D.
If anything positive can come out of this travesty it's this -- Merck stood up for what it thought was right, won more than they lost -- and showed the trial bar, pundits, and pols that they weren't going to be doormats for cheap shots and SiCKO soundbites.
And that's a valuable lesson for the rest of the Big Pharma brethren.
In case you missed the news, SiCKO is now out on DVD – and it seems that New York Times columnist Paul Krugman made a beeline to Blockbuster.
Call it an early Hanukah present for a true believer.
His column, “Health Care Excuses,†replays the same tried and untrue arguments made in the Moore-ish cult classic. Here’s a link:
http://www.nytimes.com/2007/11/09/opinion/09krugman.html?ref=opinion
Looks like he read our November 5th blog, “Debunking Some Health Care Urban Myths" --
http://drugwonks.com/2007/11/debunking_some_health_care_urban_myths.html
-- where we take many of the more infamous Moore/Krugisms to task.
Well, at least he's reading -- if not learning.
(And we'll keep trying.)
Call it an early Hanukah present for a true believer.
His column, “Health Care Excuses,†replays the same tried and untrue arguments made in the Moore-ish cult classic. Here’s a link:
http://www.nytimes.com/2007/11/09/opinion/09krugman.html?ref=opinion
Looks like he read our November 5th blog, “Debunking Some Health Care Urban Myths" --
http://drugwonks.com/2007/11/debunking_some_health_care_urban_myths.html
-- where we take many of the more infamous Moore/Krugisms to task.
Well, at least he's reading -- if not learning.
(And we'll keep trying.)
ASCO/ASH, ACCC, EMEA and now the FDA all say the following with respect to ESA dosing
"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."
CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.
Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?
Here is the FDA label update.
http://www.fda.gov/cder/drug/infopage/RHE/default.htm
"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."
CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.
Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?
Here is the FDA label update.
http://www.fda.gov/cder/drug/infopage/RHE/default.htm
Peter and I are leaving for Israel today where will be participating in and co-sponsoring a three day program for Israeli biotech startups designed to help them improved their ability to become full fledged companies. Israel is home to some of the best translational science in the world and providing companies insights to the policy and regulatory environment in the US can help enhance value and improve efficiency. The conference is entitled Health Care Technological Innovation: From Idea to Commercialization. It's co-sponsored by the Israel Life Science Industry, The International Institute for Biotechnology Entrenpreneurship, Tel Aviv University's Recanti School of Business and CMPI.
It's Peter's first trip and as for me, I get to see my son who, as some of you know, is serving in the IDF.
Here's the conference agenda:
http://biomedmanagement.tau.ac.il/
We will blog from Israel!
It's Peter's first trip and as for me, I get to see my son who, as some of you know, is serving in the IDF.
Here's the conference agenda:
http://biomedmanagement.tau.ac.il/
We will blog from Israel!
Per the current shenanigans going in at the IGWG in Geneva, here's a breath of fresh air -- a thoughtful analysis on the actual state of affairs vis-Ã -vis drug development and patents. It's by Philip Stevens of the International Policy Network and appears in Investors Business Daily. It's a potent rebuttal of the various and sundry half-truths put forward by Jamie Love, the Pancho Villa of Patents, and his fellow travelers.
If R&D Ain't Broke, Why Break It?
BY PHILIP STEVENS
There is a long list of complaints against the current system of drug development:
• Patents and profits have failed to produce new medications for the diseases of poor countries.
• There are not enough groundbreaking new therapies.
• Profiteering companies routinely make tiny changes to drugs to extend patents and shut out competition.
• Not only that, the patent system allows companies to charge astronomical sums for the drugs they do produce.
These allegations come from a powerful group of ideological nongovernmental organizations, or NGOs, that abhor profit in medicine and are pushing the World Health Organization toward a global treaty that would completely change the way drugs are researched and developed.
But before taking their medicine, we should take a close look at the label — and the nasty side effects.
This Medical Research and Development Treaty, proposed by Brazil and Kenya, would have a central U.N. bureaucracy deciding what diseases to research while allocating funds, contracts and prizes accordingly. Its expert scientists would ensure that all diseases are given appropriate resources, including the handful of "unprofitable" tropical diseases in poor counties.
NGOs, including humanitarian groups such as Medecins Sans Frontieres, hope this scheme will solve the failings of the current system at a stroke.
Because intellectual property would be owned by governments, drug prices would plummet. Less would be spent on frivolous ailments such as erectile dysfunction and baldness, and more on malaria and HIV/AIDS. Resources could be concentrated on groundbreaking "blockbuster" drugs, instead of the small molecular changes that are routinely patented now.
When the WHO first mooted the treaty in May 2006, MSF called it a "breakthrough" that "would ensure that patients' needs rather than profits drove innovation."
If the aim is to punish Big Pharma's stockholders, it will probably work. But as a way of producing cheap innovative drugs for the poor, it fails on several counts.
First, giving such discretionary power to bureaucrats would politicize R&D. In a centrally directed system — as in Britain's health service — resources tend to go to the loudest pressure groups. Other diseases would be neglected in favor of politically high-profile diseases such as HIV/AIDS.
Neither is it clear how an unelected body in Geneva would be better at setting priorities than the thousands of scientists and businessmen whose livelihoods depend on getting these decisions right.
Second, using state-funded prizes as the major incentive for R&D is problematic. The prize committee can never know the true market value of the drug it is hoping to create. If the prize is too low, companies will be reluctant to compete for future prizes, leading to fewer new drugs. If the prize is too high, the new system will squander taxpayers' money and divert effort from other areas of research.
Prizes were much favored in the Soviet Union, but they never resulted in much innovation.
Third, the treaty would turn drug manufacturers into utilities, living off government contracts. Removing the freedom to decide what to sell and at what price will discourage companies from risking capital to reap rewards, which is how innovation happens.
This is a clear lesson from regulated utilities such as water, electricity, telephones and gas. In a minimal-profit sector, companies do the bare minimum to fulfill their contractual obligations.
Most fundamentally, the treaty does not solve the greatest health care problem in poorer countries: how to actually get the drugs to patients in the face of crumbling hospitals and chronic shortages of doctors and nurses.
In 2006, the director of the World Health Organization's HIV division, Kevin De Cock, said "it is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don't exist."
If prices are an issue, why not scrap taxes and tariffs on medicines, which can increase the manufacturer's price by up to 11 times? These taxes on the sick are levied by many poor countries, including Kenya.
Removing commercial incentives will make companies retreat from the difficult and expensive work on cures for cancer and the like, and try to regain lost profits in politically safe "lifestyle" ailments. And governments have yet to demonstrate that they can produce drugs themselves.
All this is worrying for the U.S., which has already allowed the draft treaty to progress too far. There are echoes of the Clinton administration's hapless negotiation of the TRIPS agreement in 1994, which is now coming back to haunt America.
That agreement on Trade-Related Aspects of Intellectual Property Rights includes a clause designed to allow emergency production of essential medicines in poor countries. In practice, its wording is so vague that it allows any government to override the patent on any drug it likes. Middle-income Brazil and Thailand are now doing exactly that.
If the negotiators from the Department of Health and Human Services do not firmly reject the proposals at the WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property in Geneva this week, there won't be any pharmaceutical patent rights worth the name. This will be a body blow to innovation.
The current patent-based R&D model has produced most of the drugs that exist. It has a few problems, but there is no point junking it for an ill-conceived NGO fantasy. The biggest losers will not be stockholders, but patients.
Well said, Philip.
If R&D Ain't Broke, Why Break It?
BY PHILIP STEVENS
There is a long list of complaints against the current system of drug development:
• Patents and profits have failed to produce new medications for the diseases of poor countries.
• There are not enough groundbreaking new therapies.
• Profiteering companies routinely make tiny changes to drugs to extend patents and shut out competition.
• Not only that, the patent system allows companies to charge astronomical sums for the drugs they do produce.
These allegations come from a powerful group of ideological nongovernmental organizations, or NGOs, that abhor profit in medicine and are pushing the World Health Organization toward a global treaty that would completely change the way drugs are researched and developed.
But before taking their medicine, we should take a close look at the label — and the nasty side effects.
This Medical Research and Development Treaty, proposed by Brazil and Kenya, would have a central U.N. bureaucracy deciding what diseases to research while allocating funds, contracts and prizes accordingly. Its expert scientists would ensure that all diseases are given appropriate resources, including the handful of "unprofitable" tropical diseases in poor counties.
NGOs, including humanitarian groups such as Medecins Sans Frontieres, hope this scheme will solve the failings of the current system at a stroke.
Because intellectual property would be owned by governments, drug prices would plummet. Less would be spent on frivolous ailments such as erectile dysfunction and baldness, and more on malaria and HIV/AIDS. Resources could be concentrated on groundbreaking "blockbuster" drugs, instead of the small molecular changes that are routinely patented now.
When the WHO first mooted the treaty in May 2006, MSF called it a "breakthrough" that "would ensure that patients' needs rather than profits drove innovation."
If the aim is to punish Big Pharma's stockholders, it will probably work. But as a way of producing cheap innovative drugs for the poor, it fails on several counts.
First, giving such discretionary power to bureaucrats would politicize R&D. In a centrally directed system — as in Britain's health service — resources tend to go to the loudest pressure groups. Other diseases would be neglected in favor of politically high-profile diseases such as HIV/AIDS.
Neither is it clear how an unelected body in Geneva would be better at setting priorities than the thousands of scientists and businessmen whose livelihoods depend on getting these decisions right.
Second, using state-funded prizes as the major incentive for R&D is problematic. The prize committee can never know the true market value of the drug it is hoping to create. If the prize is too low, companies will be reluctant to compete for future prizes, leading to fewer new drugs. If the prize is too high, the new system will squander taxpayers' money and divert effort from other areas of research.
Prizes were much favored in the Soviet Union, but they never resulted in much innovation.
Third, the treaty would turn drug manufacturers into utilities, living off government contracts. Removing the freedom to decide what to sell and at what price will discourage companies from risking capital to reap rewards, which is how innovation happens.
This is a clear lesson from regulated utilities such as water, electricity, telephones and gas. In a minimal-profit sector, companies do the bare minimum to fulfill their contractual obligations.
Most fundamentally, the treaty does not solve the greatest health care problem in poorer countries: how to actually get the drugs to patients in the face of crumbling hospitals and chronic shortages of doctors and nurses.
In 2006, the director of the World Health Organization's HIV division, Kevin De Cock, said "it is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don't exist."
If prices are an issue, why not scrap taxes and tariffs on medicines, which can increase the manufacturer's price by up to 11 times? These taxes on the sick are levied by many poor countries, including Kenya.
Removing commercial incentives will make companies retreat from the difficult and expensive work on cures for cancer and the like, and try to regain lost profits in politically safe "lifestyle" ailments. And governments have yet to demonstrate that they can produce drugs themselves.
All this is worrying for the U.S., which has already allowed the draft treaty to progress too far. There are echoes of the Clinton administration's hapless negotiation of the TRIPS agreement in 1994, which is now coming back to haunt America.
That agreement on Trade-Related Aspects of Intellectual Property Rights includes a clause designed to allow emergency production of essential medicines in poor countries. In practice, its wording is so vague that it allows any government to override the patent on any drug it likes. Middle-income Brazil and Thailand are now doing exactly that.
If the negotiators from the Department of Health and Human Services do not firmly reject the proposals at the WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property in Geneva this week, there won't be any pharmaceutical patent rights worth the name. This will be a body blow to innovation.
The current patent-based R&D model has produced most of the drugs that exist. It has a few problems, but there is no point junking it for an ill-conceived NGO fantasy. The biggest losers will not be stockholders, but patients.
Well said, Philip.
DrugWonks is proud to have been chosen by BioTech360 (a publication of The Scientist) as the #1 “must read†blog for those in the wonderful world of biotech.
According to Biotech360 blogger Yali Friedman, “As the forum for the Center for Medicine in the Public Interest, Drug Wonks covers policy affecting biotechnology. This blog also tracks and responds to Op-Eds and other news items, providing additional perspective on many important topics.â€
His top five list can be found at:
http://www.biotech360.com/biotechArticleDisplay.jsp?biotechArticleId=100039
Thanks Yali.
According to Biotech360 blogger Yali Friedman, “As the forum for the Center for Medicine in the Public Interest, Drug Wonks covers policy affecting biotechnology. This blog also tracks and responds to Op-Eds and other news items, providing additional perspective on many important topics.â€
His top five list can be found at:
http://www.biotech360.com/biotechArticleDisplay.jsp?biotechArticleId=100039
Thanks Yali.
Frank Lichtenberg published a study in Health Affairs demonstrating something that we already knew: a lot of the drug coverage of part D crowded out private drug coverage and increased utilization by about 12 percent. Much of the increase was in the area of generic drug spending. So much for the Big Pharma windfall. Part D was essentially what those of us who supported said it would be: a modernization of Medicare the goal of which would be to extend drug coverage to a program that did not have it and to milions of seniors who were poor and were receiving drug coverage through restrictive Medicaid formularies.
So what's the difference between supporting a Part D crowd out and not an SCHIP crowd out? Part D is a step towards privatizing Medicare -- full of choices and pasrt of an effort to get seniors to buy into private plans and everyone knows it. SCHIP is a step towards socializing healthcare and everyone knows it.
Lichtenberg points out also that Medicare Part D has the benefit of reducing Medicare spending overall. We need studies to demonstrate this happening at various income groups and disease states.
http://content.healthaffairs.org/cgi/content/abstract/26/6/1735
So what's the difference between supporting a Part D crowd out and not an SCHIP crowd out? Part D is a step towards privatizing Medicare -- full of choices and pasrt of an effort to get seniors to buy into private plans and everyone knows it. SCHIP is a step towards socializing healthcare and everyone knows it.
Lichtenberg points out also that Medicare Part D has the benefit of reducing Medicare spending overall. We need studies to demonstrate this happening at various income groups and disease states.
http://content.healthaffairs.org/cgi/content/abstract/26/6/1735
Those screams you heard came from "I hate Big Pharma" being hoisted on the drug safety petard of their own making as Momenta's hard to mimic version of Lovenox was being rejected by the FDA because of concerns that the company hadn't accounted for uncountrolled immune reactions to its version of the product. And of course that doesn't even begin to to address what sort of studies Momenta would have to undertake to deal with safety concerns, what risk mitigation system it would have to put in place, what post marketing surveillance it would have to conduct, what clinical trials data it would have to post, blah,blah blah.
FOBs will hit the market eventually. But it is great to see those who take drug companies to task about safety seek to rationalize rushing FOBs to market without similar consumer protections. And they care more about rushing FOBs to market than accelerating the review of new life saving medicines which Momemta is also working on. It's called I hate pharma hypocrisy.
FOBs will hit the market eventually. But it is great to see those who take drug companies to task about safety seek to rationalize rushing FOBs to market without similar consumer protections. And they care more about rushing FOBs to market than accelerating the review of new life saving medicines which Momemta is also working on. It's called I hate pharma hypocrisy.
Had a look at the Non-Prescription Drug Modernization yet? It was just introduced by Representative Henry Waxman (R, CA), Representative Tom Allen (D, ME), and Senator Ted Kennedy (D, MA.). It’s a well-meaning, but knee-jerk reaction in response to the recent FDA advisory committee vote over banning over-the-counter cough and cold medicines for children under six.
Here’s a link to the legislation:
http://oversight.house.gov/documents/20071106143446.pdf
Among other things, this bill would allow the FDA to ban marketing of the drugs while the rulemaking process was still under way.
That’s right – “ban†advertising.
We’ve already covered how we feel about the recent AdComm vote (see two October 19th posts, “Dosing for Dummies†and “Cough, Sniffle, Sneeze – No OTC Meds for Children, Pleaseâ€). Per this new legislation, we concur with our friend Adonis Hoffman over at the American Association of Advertising Agencies.
Here’s what Adonis has to say:
"We are all concerned about the cough and cold medications for children that have been in the news reports lately. Nobody benefits from false or misleading advertising of any kind, whether it is for over-the-counter or prescription medications."
He also, wisely, point out that there are already "ample and appropriate regulatory penalties in place to handle these problems. The authority of both the Federal Trade Commission and the Food and Drug Administration is intact. I'm not sure whether there is a need for new changes."
Hopefully this will be a robust debate over how good communications can improve the public health -- not another public flogging of the industry.
Just call us starry-eyed optimists.
Here’s a link to the legislation:
http://oversight.house.gov/documents/20071106143446.pdf
Among other things, this bill would allow the FDA to ban marketing of the drugs while the rulemaking process was still under way.
That’s right – “ban†advertising.
We’ve already covered how we feel about the recent AdComm vote (see two October 19th posts, “Dosing for Dummies†and “Cough, Sniffle, Sneeze – No OTC Meds for Children, Pleaseâ€). Per this new legislation, we concur with our friend Adonis Hoffman over at the American Association of Advertising Agencies.
Here’s what Adonis has to say:
"We are all concerned about the cough and cold medications for children that have been in the news reports lately. Nobody benefits from false or misleading advertising of any kind, whether it is for over-the-counter or prescription medications."
He also, wisely, point out that there are already "ample and appropriate regulatory penalties in place to handle these problems. The authority of both the Federal Trade Commission and the Food and Drug Administration is intact. I'm not sure whether there is a need for new changes."
Hopefully this will be a robust debate over how good communications can improve the public health -- not another public flogging of the industry.
Just call us starry-eyed optimists.
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.
