Latest Drugwonks' Blog
At first glance, Japan's health-care system seems superior to America's. Its infant mortality rate is among the world's lowest. Japan's life expectancy is the world's highest for women (85.6 years) and the fourth-highest for men (80.4 years).
All this has been achieved at a fraction of what the United States spends. Only 9 percent of Japan's gross domestic product is spent on health care, while America spends almost twice that. It seems like the perfect system. For many, perhaps it is -- unless you actually need to use it ... and particularly if you have cancer.
Have a look at this new op-ed that appears in the Commentary section of today's edition of The Washington Times:
http://www.washingtontimes.com/commentary/20070222-084946-2121r.htm
A health-care system's success shouldn't simply be based on life expectancy and fiscal policy but rather on individual outcomes.
Candidates in the 2008 presidential race have already begun vying for Americans' votes. Improving the nation's health-care system has already surfaced as a major issue for all those seeking the job. But it's hardly an improvement on our health-care system if politicians seek to turn our life-and-death health-care decisions over to bureaucrats and budget-crunchers.
Japan's cancer refugees have just issued a wake-up call to their own government. It would be a shame if we didn't heed their warning and ended up with cancer refugees of our own.
All this has been achieved at a fraction of what the United States spends. Only 9 percent of Japan's gross domestic product is spent on health care, while America spends almost twice that. It seems like the perfect system. For many, perhaps it is -- unless you actually need to use it ... and particularly if you have cancer.
Have a look at this new op-ed that appears in the Commentary section of today's edition of The Washington Times:
http://www.washingtontimes.com/commentary/20070222-084946-2121r.htm
A health-care system's success shouldn't simply be based on life expectancy and fiscal policy but rather on individual outcomes.
Candidates in the 2008 presidential race have already begun vying for Americans' votes. Improving the nation's health-care system has already surfaced as a major issue for all those seeking the job. But it's hardly an improvement on our health-care system if politicians seek to turn our life-and-death health-care decisions over to bureaucrats and budget-crunchers.
Japan's cancer refugees have just issued a wake-up call to their own government. It would be a shame if we didn't heed their warning and ended up with cancer refugees of our own.
Recently I spoke at a joint California Healthcare Institute/Pacific Research Institute conference on evidence-based medicine -- with a particular focus on how it isn't working all that well Down Under, and a few important lessons we should learn from the Aussie experience.
Here's a video podcast of my remarks:
http://sys-con.com/read/340224.htm
Enjoy.
Here's a video podcast of my remarks:
http://sys-con.com/read/340224.htm
Enjoy.
Here's Derek Lowe of pipeline.Corante.com blogging about his take of our first Media and Medical Science conference.... Derek talks like he writes, witty, unvarnished and informative ...
In The Pipeline
We had wonderful attendance, great moderators and panelists, including another first time blogger, Ed Silverman who just launched http://www.pharmalot.com
Can I get away with just saying that 1. coverage does drive policy and that the more science based the coverage, the better the policy and 2. everyone that has skin in the game has an obligation to, in the words of Greg Simon, "stop whining (which he said with a smile) and start working to change the conversation" 3. everyone needs to do a better job explaining what drug and biotech companies do.
Key words.... consumerism, transparency, honesty, benefits, skepticism (on the part of the media ) biomarkers.
In The Pipeline
We had wonderful attendance, great moderators and panelists, including another first time blogger, Ed Silverman who just launched http://www.pharmalot.com
Can I get away with just saying that 1. coverage does drive policy and that the more science based the coverage, the better the policy and 2. everyone that has skin in the game has an obligation to, in the words of Greg Simon, "stop whining (which he said with a smile) and start working to change the conversation" 3. everyone needs to do a better job explaining what drug and biotech companies do.
Key words.... consumerism, transparency, honesty, benefits, skepticism (on the part of the media ) biomarkers.
Today CMPI is hosting "Medicine and the Media: Redefining Roles and Responsibilities." If you can't make it to DC for this event (and we hope you can), please join us via audio webcast. Sign-up information can be found by clicking on the link below:
http://www.visualwebcaster.com/Stratosphere/37936/reg.html
And if you can't join us for the whole day, please be sure not to miss FDA Commissioner von Eschenbach's lunchtime speech on "FDA and the Media."
Hope you can join us.
http://www.visualwebcaster.com/Stratosphere/37936/reg.html
And if you can't join us for the whole day, please be sure not to miss FDA Commissioner von Eschenbach's lunchtime speech on "FDA and the Media."
Hope you can join us.
Imagine a world without intellectual property protection. Now stop imagining and start paying attention to what's going on in Thailand.
Have a look at this new op-ed in today's Baltimore Sun ...
http://www.baltimoresun.com/news/opinion/oped/bal-op.patents20feb20,0,89958.story?coll=bal-oped-headlines
... and let's talk.
Have a look at this new op-ed in today's Baltimore Sun ...
http://www.baltimoresun.com/news/opinion/oped/bal-op.patents20feb20,0,89958.story?coll=bal-oped-headlines
... and let's talk.
In light of the pro-generic tilt of public policy these days the following sidebar from the Pharmaceutical Business Review might be of interest:
Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.
It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.
Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."
Ouch.
Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...
This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...
And these are the good guys Waxman, Love and co are supporting.
Ranbaxy has revealed that federal officials have conducted a surprise raid at its New Jersey offices and manufacturing site, during which paper and electronic documents were taken. Although the raid is believed to have been carried out by the Food and Drug Administration, the agency has not confirmed this report. The Indian-based generic drug firm claims to be mystified by the raid, and insisted that it was not aware of any wrongdoing. As the FDA refuses to comment on ongoing investigations, the reasons behind the swoop will remain a mystery for the time being.
It should be noted that Ranbaxy told the Indian press that they think the brand companies are behind the raid. Maybe Jamie Love can explain this connection.
The PBR report does not note that the Department of Justice is conducting the investigation and it does not rush in unless it has good reason to do so. My guess is that it might have something to do with fudging on filings, something Ranbaxy has done before.
Memories are short but some might recall that in 2004 the WHO had to delist Ranbaxy's HIV drugs when it found that it had no safety and efficacy data for them. As the WHO noted then: "The drugs will be delisted until Ranbaxy can submit data of new studies providing unequivocal evidence of the products' bioequivalence with the originator medicines."
Ouch.
Ranbaxy did get FDA approval for a couple of HIV drugs in 2005. But what does that say about all those patients taking drugs based on files that the WHO couldn't even accept...
This is a story worth following in light of the corruption and shoddy products the junta-run drug company in Thailand is getting ready to pump out...
And these are the good guys Waxman, Love and co are supporting.
Follow on biologics (generic biologics) will be a safe scientific fact of life in the near future. But that's not fast enough for Congressional Democrats who want to use the biotech industry as a source of income redistribution and a cash cow for expanding SCHIP. So it has turned to Bill Haddad, an individual who is the godfather of the Hatch-Waxman act and whose company Biogenerics, stands to profit from the creation of FDA approval of generic biotech medicines to write the legislation for followon biologics. In its current form it is sweetheart deal for generics firm: No testing requirements, no postmarket studies, just show up with the files from the innovator company and your own brew. As for the $70 billion in savings, which just coincidentally equals the amount needed to fund the SCHIP expansion, Dems have turned to the PBM trade group -- which will profit from early termination of biotech patent -- to come up with projections of how much cash will be saved by swiitching patienets to knockoffs.
Only one problem, the standards in the bill are nearly a half century old. The same members of Congress bawling about how FDA can't protest the public against unsafe drugs would expose people to biotech products produced in ways that have caused seizures, paralysis, and incurable blood disorders in thousands of patients over the years. The other problem is that the biotech drugs they want to copy are not even off patent. They want to make that problem disappear by just legislating the right of some companies to contest their patent claims out of existentence. Why the disregard of IP and public health? To reward political cronies and appease constituencies who want to expand Medicaid as a way of advancing national health care.
Only one problem, the standards in the bill are nearly a half century old. The same members of Congress bawling about how FDA can't protest the public against unsafe drugs would expose people to biotech products produced in ways that have caused seizures, paralysis, and incurable blood disorders in thousands of patients over the years. The other problem is that the biotech drugs they want to copy are not even off patent. They want to make that problem disappear by just legislating the right of some companies to contest their patent claims out of existentence. Why the disregard of IP and public health? To reward political cronies and appease constituencies who want to expand Medicaid as a way of advancing national health care.
Protecting people against disease or the drugs that are developed to treat the illnesses in the first place?
Here's a new article (by me) from this week's edition of Barron's. The title says it all, "Even Safety Needs Limits."
To read the article, click on the link below:
Download file
To entice you on, here's the closing paragraph:
"FDA decisions can be made more transparent to all interested parties. The agency can improve cooperation with the industry, patient groups, physicians, hospitals, academia, and other government agencies. The goal should not be conducting more time-consuming discussion, but finding more effective ways to bring medical advances to patients as quickly as possible."
To read the article, click on the link below:
Download file
To entice you on, here's the closing paragraph:
"FDA decisions can be made more transparent to all interested parties. The agency can improve cooperation with the industry, patient groups, physicians, hospitals, academia, and other government agencies. The goal should not be conducting more time-consuming discussion, but finding more effective ways to bring medical advances to patients as quickly as possible."
From today's edition of the Boston Globe, our rebuttal to Marcia Angell's most recent me-too mania:
Similar drugs, but world of difference
Take away message: There is no such thing as a "me-too" drug" because there is no such thing as a "me-too" patient.
Similar drugs, but world of difference
Take away message: There is no such thing as a "me-too" drug" because there is no such thing as a "me-too" patient.
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.
