Latest Drugwonks' Blog
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.
FDA Warns of Wrong Drugs
Being Sold Over the Internet
Associated Press
February 16, 2007 6:03 p.m.
Consumers who thought they were purchasing sleep aids, antidepressants and other drugs over the Internet instead were shipped a powerful antipsychotic, sending some unwitting victims to the emergency room, federal health officials warned Friday.
The Food and Drug Administration said a number of consumers took the schizophrenia drug, haloperidol, after being shipped what they thought were a variety of different pills, including Ambien, a sleep aid, and the anti-anxiety medications Xanax and Ativan. Others thought they were getting the antidepressant Lexapro.
Preliminary analysis of the pills, packaged in plain plastic bags and mailed in envelopes bearing Greek postmarks, suggest they contain haloperidol. The
FDA said it had reports of several consumers seeking emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after taking the pills.
The FDA used the occasion to remind consumers of the possible dangers of buying prescription drugs on the Web.
The FDA posted images of the suspect pills and their shipping packages on its Web site to help consumers identify any suspect product they may have ordered.
Consumers apparently ordered the drugs through a variety of commercial Web sites. The FDA said it was investigating.
Being Sold Over the Internet
Associated Press
February 16, 2007 6:03 p.m.
Consumers who thought they were purchasing sleep aids, antidepressants and other drugs over the Internet instead were shipped a powerful antipsychotic, sending some unwitting victims to the emergency room, federal health officials warned Friday.
The Food and Drug Administration said a number of consumers took the schizophrenia drug, haloperidol, after being shipped what they thought were a variety of different pills, including Ambien, a sleep aid, and the anti-anxiety medications Xanax and Ativan. Others thought they were getting the antidepressant Lexapro.
Preliminary analysis of the pills, packaged in plain plastic bags and mailed in envelopes bearing Greek postmarks, suggest they contain haloperidol. The
FDA said it had reports of several consumers seeking emergency medical treatment for symptoms such as difficulty in breathing, muscle spasms and muscle stiffness after taking the pills.
The FDA used the occasion to remind consumers of the possible dangers of buying prescription drugs on the Web.
The FDA posted images of the suspect pills and their shipping packages on its Web site to help consumers identify any suspect product they may have ordered.
Consumers apparently ordered the drugs through a variety of commercial Web sites. The FDA said it was investigating.
We have been saying this all along.
Part D is working...drugs save money in the long run. Giving people choices to steer dollars to in ways that actually prevent disease (more drugs, newer drugs, better drugs) is a great investment.
It doesn't take a Nobel Prize economist to say that (some like Joe Stiglitz still can't figure it out) but it's great when they do.
http://online.wsj.com/article/SB117159975453110920.html?mod=opinion_main_commentaries
Part D is working...drugs save money in the long run. Giving people choices to steer dollars to in ways that actually prevent disease (more drugs, newer drugs, better drugs) is a great investment.
It doesn't take a Nobel Prize economist to say that (some like Joe Stiglitz still can't figure it out) but it's great when they do.
http://online.wsj.com/article/SB117159975453110920.html?mod=opinion_main_commentaries
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.
