Latest Drugwonks' Blog
The President intends to nominate Tevi David Troy, of New York, to be Deputy Secretary of Health and Human Services. Dr. Troy currently serves as Deputy Assistant to the President for Domestic Policy. Prior to this, he served as Special Assistant to the President and Deputy Cabinet Secretary. Earlier in his career, he served as Deputy Assistant Secretary for Policy at the Department of Labor. Dr. Troy received his bachelor’s degree from Cornell University and his master’s degree and PhD from The University of Texas at Austin.
Anyone who knows Tevi knows that HHS has gained a great public servant and staunch Yankee fan.
Kerry Weems replaces Leslie Norwalk as CMS Administrator.
Anyone who knows Tevi knows that HHS has gained a great public servant and staunch Yankee fan.
Kerry Weems replaces Leslie Norwalk as CMS Administrator.
Biotech entrepreneuers from India, China, Brazil don't talk about breaking patents, price controls, hating big Pharma...none of the junk that fills the time and effort of the NGOs whose efforts among to -- in the words of one participant "a rounding error" in the war against disease. Rather, it is all about partnerships, raising capital, IP protection and most important...harmonization of regulatory standards with the FDA's Critical Path efforts.
I cannot tell you what excitement the Critical Path effort has stirred among many of the start ups here. The idea of shortening development times, micro-dosings, using biomarkers for toxicity studies, being able to submit a single application to a single standard is the single most important barrier to the development of products for unmet global health needs. Note to the FDA, the Critical Path needs to go global to rev up the global health revolution. Companies overseas DO want to import medicines to the US, but ONLY if they are safe, effective and valuable.
I cannot tell you what excitement the Critical Path effort has stirred among many of the start ups here. The idea of shortening development times, micro-dosings, using biomarkers for toxicity studies, being able to submit a single application to a single standard is the single most important barrier to the development of products for unmet global health needs. Note to the FDA, the Critical Path needs to go global to rev up the global health revolution. Companies overseas DO want to import medicines to the US, but ONLY if they are safe, effective and valuable.
Our view on the Senate debate over FDA reform: "Bolster medicine safety"
Thoughts and comments most welcome. Now's the time to make a difference.
Thoughts and comments most welcome. Now's the time to make a difference.
New Critical Path Report Highlights Research Needed to Foster Generic Drug Development
The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.
The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.
"This report pinpoints the barriers that are limiting the availability of additional generic drug options," said Gary Buehler, R.Ph., director, FDA's Office of Generic Drugs. "We hope these findings will encourage research collaboration, lower these barriers and accelerate access to safe and effective generic drugs."
Before they can be approved, generic drugs must have the same active ingredient, dosage form, strength, and conditions of use as the brand name drug. The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.
While straightforward tests of blood plasma levels are sufficient to demonstrate bioequivalence for most generic drug candidates, these common tests generally are not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications such as anti-fungal creams. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices.
For example, generic drug products that contain the ozone-depleting substance chlorofluorocarbon will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an alternative, hydrofluoroalkane.
The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.
In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.
Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.
The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.
The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.
"This report pinpoints the barriers that are limiting the availability of additional generic drug options," said Gary Buehler, R.Ph., director, FDA's Office of Generic Drugs. "We hope these findings will encourage research collaboration, lower these barriers and accelerate access to safe and effective generic drugs."
Before they can be approved, generic drugs must have the same active ingredient, dosage form, strength, and conditions of use as the brand name drug. The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.
While straightforward tests of blood plasma levels are sufficient to demonstrate bioequivalence for most generic drug candidates, these common tests generally are not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications such as anti-fungal creams. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices.
For example, generic drug products that contain the ozone-depleting substance chlorofluorocarbon will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an alternative, hydrofluoroalkane.
The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.
In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.
Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.
Important to point out that the Dorgan Amendment would allow importation from Canada, Switzerland, New Zealand, Australia, Japan.
And the EU -- "but does not include a member country with respect to which the country's Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired."
Nice try. Parallel trade makes the entire EU a free trade zone when it comes to pharmaceuticals. Consider the over 20% of drugs sold in Great Britain that originate in other, lower cost parts of Europe like Greece and Portugal, Latvia and Estonia.
Senator Flickertail's amendment also demands that approved nations "have statutory or regulatory requirements that require the review of drugs for safety and effectiveness by an entity of the government of the country."
Folks, "requirements" can mean a lot of things from nation to nation. What actually happens can be something altogether different.
And the EU -- "but does not include a member country with respect to which the country's Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired."
Nice try. Parallel trade makes the entire EU a free trade zone when it comes to pharmaceuticals. Consider the over 20% of drugs sold in Great Britain that originate in other, lower cost parts of Europe like Greece and Portugal, Latvia and Estonia.
Senator Flickertail's amendment also demands that approved nations "have statutory or regulatory requirements that require the review of drugs for safety and effectiveness by an entity of the government of the country."
Folks, "requirements" can mean a lot of things from nation to nation. What actually happens can be something altogether different.
it is hardly suprising to those of us who have watched cardiovascular advances up close in the clinical trenches to find out that the hospital death rate from heart attack or the incidence of severe heart failure is down by almost half. And though we should applaud this affirmation, we shouldn't be derailed from a larger point that death rate is not the only issue. We have known for a long time that patients feel better after angioplasties and stents, and we have seen the medications work to relieve symptoms and stabilize patients. It isn't just a question of survival - it's also a question of survive how? It may be a subtle point, but if we applaud the lower death rate statistic too much, it may undermine the point that this isn't the only criteria for gauging medical success, even if it is an easy thing to measure.
Further thoughts on the recent Supreme Court decision on patents, "obvious" innovation, and incremental innovation.
According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without financial incentives and intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.
Allowing the private sector to bear both the risk and the reward for successfully developing pharmaceutical, biologic, and medical device products has been and remains the most successful and efficient way to meet our public health goals
Competition among companies, both here in the U.S and abroad, assures a diversity of expertise in various diseases. This competitive model assures that, when a public health crisis is identified, there will be an available pool of talent, experience, and infrastructure to give us enhanced opportunities to successfully identify and produce cures and vaccines in an expedited timeframe.
"Obvious?" Hopefully.
According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without financial incentives and intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.
Allowing the private sector to bear both the risk and the reward for successfully developing pharmaceutical, biologic, and medical device products has been and remains the most successful and efficient way to meet our public health goals
Competition among companies, both here in the U.S and abroad, assures a diversity of expertise in various diseases. This competitive model assures that, when a public health crisis is identified, there will be an available pool of talent, experience, and infrastructure to give us enhanced opportunities to successfully identify and produce cures and vaccines in an expedited timeframe.
"Obvious?" Hopefully.
Flickertail Senator Byron Dorgan continues to pursue his unworkable, unsafe, unwise and, well, just plain foolish amendment on drug importation.
What he should do is spend a few minutes on the FDA website, where he would find this new safety alert ...
FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers
The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs.
On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.
None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.
While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.
Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The correct expiration date for this lot number is actually March 2005. Pictures of the counterfeit Xenical capsules provided by Roche can be viewed at http://www.fda.gov/bbs/topics/news/photos/xenical/html
Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the "Our Websites" heading. Four of these Web sites previously have been identified by FDA's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.
At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online.
Senator Flickertail -- you can't be for safety and against it at the same time.
What he should do is spend a few minutes on the FDA website, where he would find this new safety alert ...
FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers
The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs.
On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.
None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.
While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.
Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The correct expiration date for this lot number is actually March 2005. Pictures of the counterfeit Xenical capsules provided by Roche can be viewed at http://www.fda.gov/bbs/topics/news/photos/xenical/html
Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the "Our Websites" heading. Four of these Web sites previously have been identified by FDA's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.
At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online.
Senator Flickertail -- you can't be for safety and against it at the same time.
As Peter points out below, a new study shows that all those people who are taking medicines based on research conducted by researchers corrupted by Big Pharma about the drugs developed by Big Pharma based on clinical trials skewed by Big Pharma and it's cozy relationship with the FDA are not dying from heart attacks as often as before.
But maybe the study is skewed.
Or as Groucho Marx said: "Either this man is dead or my watch has stopped ticking."
But maybe the study is skewed.
Or as Groucho Marx said: "Either this man is dead or my watch has stopped ticking."
Got an e-mail this morning with a one word subject line, "Wow!"
And "wow" it was. And "wow" it is.
In just six years, death rates and heart failure in hospitalized heart attack patients have fallen sharply, most likely because of better treatment, the largest international study of its kind suggests.
The promising trend parallels the growing use of cholesterol-lowering drugs, powerful blood thinners, and angioplasty, the procedure that opens clogged arteries, the researchers said.
“These results are really dramatic, because, in fact, they’re the first time anybody has demonstrated a reduction in the development of new heart failure,†said lead author Dr. Keith Fox, a cardiology professor at the University of Edinburgh.
The six-year study involved nearly 45,000 patients in 14 countries who had major heart attacks or dangerous partial artery blockages. The percentage of patients who died in the hospital or who developed heart failure was nearly cut in half from 1999 to 2005.
And the heart attack patients treated most recently were far less likely to have another attack within six months of being hospitalized when compared to the patients treated six years earlier -- a sign that the more aggressive efforts of doctors in the last few years are working. There have been other signs that better treatment of heart patients has been saving lives, but not on a scale as large as this international study, the researchers said.
“It’s much more dramatic than we expected, in the course of six years,†Fox said.
The study appears in Wednesday’s Journal of the American Medical Association. It was funded by a grant from Sanofi-Aventis, maker of several heart drugs including Plavix and ACE inhibitors. Fox and several other authors reported getting fees and grants from Sanofi and other drug makers.
Dr. Steven Nissen, former president of the American College of Cardiology and a Cleveland Clinic heart specialist, said the study doesn’t prove the recommended treatments were saving lives but he suspects that’s the case.
“I really am encouraged that those things that appear in our guidelines are being used by physicians around the world,†Nissen said.
Here's a link to a more complete report:
http://www.msnbc.msn.com/id/18417962/from/ET/
And, for your chuckle of the morning, remember the words of Robert Bloch,
"I have the heart of a child. I keep it in a jar on my shelf."
And "wow" it was. And "wow" it is.
In just six years, death rates and heart failure in hospitalized heart attack patients have fallen sharply, most likely because of better treatment, the largest international study of its kind suggests.
The promising trend parallels the growing use of cholesterol-lowering drugs, powerful blood thinners, and angioplasty, the procedure that opens clogged arteries, the researchers said.
“These results are really dramatic, because, in fact, they’re the first time anybody has demonstrated a reduction in the development of new heart failure,†said lead author Dr. Keith Fox, a cardiology professor at the University of Edinburgh.
The six-year study involved nearly 45,000 patients in 14 countries who had major heart attacks or dangerous partial artery blockages. The percentage of patients who died in the hospital or who developed heart failure was nearly cut in half from 1999 to 2005.
And the heart attack patients treated most recently were far less likely to have another attack within six months of being hospitalized when compared to the patients treated six years earlier -- a sign that the more aggressive efforts of doctors in the last few years are working. There have been other signs that better treatment of heart patients has been saving lives, but not on a scale as large as this international study, the researchers said.
“It’s much more dramatic than we expected, in the course of six years,†Fox said.
The study appears in Wednesday’s Journal of the American Medical Association. It was funded by a grant from Sanofi-Aventis, maker of several heart drugs including Plavix and ACE inhibitors. Fox and several other authors reported getting fees and grants from Sanofi and other drug makers.
Dr. Steven Nissen, former president of the American College of Cardiology and a Cleveland Clinic heart specialist, said the study doesn’t prove the recommended treatments were saving lives but he suspects that’s the case.
“I really am encouraged that those things that appear in our guidelines are being used by physicians around the world,†Nissen said.
Here's a link to a more complete report:
http://www.msnbc.msn.com/id/18417962/from/ET/
And, for your chuckle of the morning, remember the words of Robert Bloch,
"I have the heart of a child. I keep it in a jar on my shelf."
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.
