Latest Drugwonks' Blog
The rapidly advancing fields of proteomics and metabolomics may provide the tools necessary to develop predictive tools and tests for early and accurate screening of devastating mental illnesses such as schizophrenia and manic depression....
PLoS Med. 2006 Nov;3(11):e428.
Disease biomarkers in cerebrospinal fluid of patients with first-onset psychosis.
"....application of modern proteomics techniques, particularly mass spectrometric approaches, holds the potential to advance the understanding of the biochemical basis of psychiatric disorders and may in turn allow for the development of diagnostics and improved therapeutics."
PLoS Med. 2006 Aug;3(8):e327.
Metabolic profiling of CSF: evidence that early intervention may impact on disease progression and outcome in schizophrenia.
Short-term treatment with atypical antipsychotic medication resulted in a normalization of the CSF disease signature in half the patients well before a clinical improvement would be expected. Furthermore, our results suggest that the initiation of antipsychotic treatment during a first psychotic episode may influence treatment response and/or outcome.
No biological basis for mental illness?
"There is nothing more frightful than ignorance in action" Goethe
PLoS Med. 2006 Nov;3(11):e428.
Disease biomarkers in cerebrospinal fluid of patients with first-onset psychosis.
"....application of modern proteomics techniques, particularly mass spectrometric approaches, holds the potential to advance the understanding of the biochemical basis of psychiatric disorders and may in turn allow for the development of diagnostics and improved therapeutics."
PLoS Med. 2006 Aug;3(8):e327.
Metabolic profiling of CSF: evidence that early intervention may impact on disease progression and outcome in schizophrenia.
Short-term treatment with atypical antipsychotic medication resulted in a normalization of the CSF disease signature in half the patients well before a clinical improvement would be expected. Furthermore, our results suggest that the initiation of antipsychotic treatment during a first psychotic episode may influence treatment response and/or outcome.
No biological basis for mental illness?
"There is nothing more frightful than ignorance in action" Goethe
I don't always agree with John Carroll's take on the issues but the FieceBiotech, Healthcare, etc websites, comments are always thought provoking, pungent, well-written, intelligent and fair. In short, some of the best health care coverage and commentary out there...Here's John's view on the GAO study
In case you haven't heard, the Government Accounting Office recently crunched the numbers and reported back that the drug discovery industry keeps spending more on research while it comes up with fewer NDAs. The trend was tracked for 11 years through 2004. I'd be willing to bet, though, that a surge in early-stage trials will eventually lead to the promised land of more marketing applications. Maybe I'm just an optimist, but the research underway in the drug discovery area is solid and it takes a number of years before the proof shows up in the NDA process. Biotech is short on magic wands and magic lamps. It's a long, slow, expensive process.
Even a nodding acquaintance with the research world, though, is enough to excite the worst kind of skeptic. The highly touted world of personalized medicine is gradually becoming a reality with solid advances in genomics, biomarkers and diagnostics. We won't get to the promised land by the end of 2007, but we'll see more steady advances as successful companies are rewarded with increased share prices.
In case you haven't heard, the Government Accounting Office recently crunched the numbers and reported back that the drug discovery industry keeps spending more on research while it comes up with fewer NDAs. The trend was tracked for 11 years through 2004. I'd be willing to bet, though, that a surge in early-stage trials will eventually lead to the promised land of more marketing applications. Maybe I'm just an optimist, but the research underway in the drug discovery area is solid and it takes a number of years before the proof shows up in the NDA process. Biotech is short on magic wands and magic lamps. It's a long, slow, expensive process.
Even a nodding acquaintance with the research world, though, is enough to excite the worst kind of skeptic. The highly touted world of personalized medicine is gradually becoming a reality with solid advances in genomics, biomarkers and diagnostics. We won't get to the promised land by the end of 2007, but we'll see more steady advances as successful companies are rewarded with increased share prices.
As chair of the Manhattan Institute's 21st Century FDA Task Force my primary function was to try to effectively convey many of the concerns Nobel Prize winner Dr. Joshua Lederberg had regarding the future of drug discovery and development. Most of the time I failed miserably. It took many drafts and much education. I was very fortunate that Dr. Lederberg was so tolerant and patient with me. Every time you met with Dr. Lederberg you received a graduate seminar in molecular biology, physics, drug development or whatever the topic of discussion happen to be.
One particular topic of Dr. Lederberg's interest now and then was the "microbiome"... In 2003 he talked about it as the next great frontier of human biology and drug discovery. He coined the term of course and has helped promote research in this area of study of the human body as “a superorganism with an extended genome that includes not only its own cells but also the fluctuating microbial genome set of bacteria and viruses that share that body space.â€It has been estimated that the human body carries more microbial cells than it does human cells. Many of these microbes, however, have not been cultivated or characterized. Some of these unknown or poorly characterized microbes probably play critical roles in maintaining human health, and the interplay among pathogenic and nonpathogenic microbes, both transient and permanent members of our microflora, is likely to exert an important influence on disease. "
As Dr. Lederberg has written, “We need more research, not only on how bacteria are virulent, but how they withhold their virulence and moderate their attacks. We need to investigate how our microbiome flora – the ones that we live with all the time –don’t cause disease and instead protect us against their competitors.â€
This past summer researchers completed a map of this super-genome -- our DNA and the bacteria together -- to launch a new field of genetic research called metagenomics.
As Jeffrey Gordon, one of the researchers from the Center for Genome Sciences at Washington University,who did the mapping points out, "Prospecting for these 'natural products' and characterizing the pathways through which they operate should provide new insights into the function of many of our human genes, new ways for defining our health, new ways for identifying impending or fully manifest diseases, plus new treatment strategies."
What is it that Sir Isaac Newton wrote to Robert Hooke? "If I have seen further it is by standing on ye shoulders of Giants."
We have all seen further and with greater clarity -- and hope -- thanks to Dr. Joshua Lederberg.
One particular topic of Dr. Lederberg's interest now and then was the "microbiome"... In 2003 he talked about it as the next great frontier of human biology and drug discovery. He coined the term of course and has helped promote research in this area of study of the human body as “a superorganism with an extended genome that includes not only its own cells but also the fluctuating microbial genome set of bacteria and viruses that share that body space.â€It has been estimated that the human body carries more microbial cells than it does human cells. Many of these microbes, however, have not been cultivated or characterized. Some of these unknown or poorly characterized microbes probably play critical roles in maintaining human health, and the interplay among pathogenic and nonpathogenic microbes, both transient and permanent members of our microflora, is likely to exert an important influence on disease. "
As Dr. Lederberg has written, “We need more research, not only on how bacteria are virulent, but how they withhold their virulence and moderate their attacks. We need to investigate how our microbiome flora – the ones that we live with all the time –don’t cause disease and instead protect us against their competitors.â€
This past summer researchers completed a map of this super-genome -- our DNA and the bacteria together -- to launch a new field of genetic research called metagenomics.
As Jeffrey Gordon, one of the researchers from the Center for Genome Sciences at Washington University,who did the mapping points out, "Prospecting for these 'natural products' and characterizing the pathways through which they operate should provide new insights into the function of many of our human genes, new ways for defining our health, new ways for identifying impending or fully manifest diseases, plus new treatment strategies."
What is it that Sir Isaac Newton wrote to Robert Hooke? "If I have seen further it is by standing on ye shoulders of Giants."
We have all seen further and with greater clarity -- and hope -- thanks to Dr. Joshua Lederberg.
From the recent GAO study
“Over the past decade, new technologies including genomics and high-throughput screening have provided tools for researchers to discover and test compounds,†according to the report. “According to industry analysts, the use of these technologies has led to increasing expenses without a commensurate increase in the number of drugs developed.
“These analysts have found that although companies have invested substantial resources in acquiring technologies that have generated vast quantities of newly discover biological data, company researchers are still learning whether the data will lead to potentially valid drug candidates, resulting in compounds and drugs that have failed in either preclinical or early clinical testing.â€
The report also states that in general over the past several years “it has become widely recognized throughout the [drug development] industry that the productivity of its research and development expenditures has been declining; that is, the number of new drugs being produced has generally declined while research and development expenses has been steadily increasing.â€
Translation....companies are investing heavily in translational research to develop targeted therapies and move into personalized medicines in order to make medicines safer and more effective...It makes drug development more expensive in the long run while not having any effect on short term productivity or efficiency.
Consumers only care about what's new and what can help me as well they should. And they want less annoying TV ads. They want information that's useful. Setting aside the chronic conspiratorial types who believe the government is in cahoots with companies to drag kids off the streets to make them permanent zombies for profit -- and you know who you are -- both drug development and the patient-prescription- physician relationship must change to be more humane, personalized and holistic. The emphasis on genomic-based research -- away from large scale clinical trials and towards biomarkers -- is part of this positive trend.
We need regulatory and policy changes to support this revolution. The dribbings of Senator Durbin and the ravings of Congressman Stark do not bode well for the future...We at Drugwonks intend 2007 to be both a year of standing firm against this dimwitted and dimming tide and offering genunine patient-centric initiatives that embrace advances in science...
“Over the past decade, new technologies including genomics and high-throughput screening have provided tools for researchers to discover and test compounds,†according to the report. “According to industry analysts, the use of these technologies has led to increasing expenses without a commensurate increase in the number of drugs developed.
“These analysts have found that although companies have invested substantial resources in acquiring technologies that have generated vast quantities of newly discover biological data, company researchers are still learning whether the data will lead to potentially valid drug candidates, resulting in compounds and drugs that have failed in either preclinical or early clinical testing.â€
The report also states that in general over the past several years “it has become widely recognized throughout the [drug development] industry that the productivity of its research and development expenditures has been declining; that is, the number of new drugs being produced has generally declined while research and development expenses has been steadily increasing.â€
Translation....companies are investing heavily in translational research to develop targeted therapies and move into personalized medicines in order to make medicines safer and more effective...It makes drug development more expensive in the long run while not having any effect on short term productivity or efficiency.
Consumers only care about what's new and what can help me as well they should. And they want less annoying TV ads. They want information that's useful. Setting aside the chronic conspiratorial types who believe the government is in cahoots with companies to drag kids off the streets to make them permanent zombies for profit -- and you know who you are -- both drug development and the patient-prescription- physician relationship must change to be more humane, personalized and holistic. The emphasis on genomic-based research -- away from large scale clinical trials and towards biomarkers -- is part of this positive trend.
We need regulatory and policy changes to support this revolution. The dribbings of Senator Durbin and the ravings of Congressman Stark do not bode well for the future...We at Drugwonks intend 2007 to be both a year of standing firm against this dimwitted and dimming tide and offering genunine patient-centric initiatives that embrace advances in science...
Under his recycled piece of legislation, drug companies would be forced to sell as much of their old products at a government set price to foreign distributors or face criminal charges. At the same time, the FDA would be expanded to handle new duties, parcel inspection, warehouse inspection, pharmacy inspection and approving after the fact that drugs made for the European market -- though they vary in dosage form, formulation, coatings and packaging -- are equally safe and effective and bioavailable without any testing.
Meanwhile, our biotech and drug companies would still be barred and restricted and delayed from marketing products in foreign markets as they seek government -- I mean -- world market prices for the new medicines. All while the FDA is forced to spend more time handling the shipping and handling needs of European middlemen instead of drug safety and drug approval here at home.
Oh, and of course there would still be time to police the expanding array of internet drug sites that sell counterfeit meds or drain real meds from poor countries that would sold to us as well....
Meanwhile, our biotech and drug companies would still be barred and restricted and delayed from marketing products in foreign markets as they seek government -- I mean -- world market prices for the new medicines. All while the FDA is forced to spend more time handling the shipping and handling needs of European middlemen instead of drug safety and drug approval here at home.
Oh, and of course there would still be time to police the expanding array of internet drug sites that sell counterfeit meds or drain real meds from poor countries that would sold to us as well....
The Fearsome Foursome of Emanuel, Dorgan, Snowe, and Emerson want drug importation and are going to try to Rahm it through Congress. That’s politics. But they’re confused. They don’t seem to understand (or they choose not to admit) that you can’t cherry-pick drugs from just Canada or one or two of the 25 European Union nations. They may only want drugs from Canada, Great Britain or France, but that’s impossible — because that’s already the law – in Europe. And that's a fact.
In Europe, parallel trade (what we call “importationâ€) is legal between all 25 EU member states. And last year 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.
This means that drugs purchased from a British pharmacy to an unknowing American consumer (or a blissfully ignorant member of the United States Congress) could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by the same British pharmacies that have had a record number of counterfeit recalls in 2006. And Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.
In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. And all the large "legitimate" Canadian internet pharmacies already admit to getting their supplies from Europe. (An interesting and important side note is that these EU-sourced drugs aren't even legal for sale in Canada. So those folks who say we'll be getting "the same drugs as Canadians" are just plain wrong.) Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.†Facts are stubborn things.
According to Sue Mitchell, editor of the British journal Epilepsy Today, “The parallel trade in medication is damaging people’s health and, at worse, putting lives at risk. Strong words, but when the discussion of the parallel importing of medication seems to revolve primarily around money, the reality of patient experience goes unheard all too often.â€
Mr. Emanuel, Ms. Emerson, Senator Dorgan, Senator Snowe -- my 18-year old son has epilepsy. Please pay attention to the facts – and leave the fiction to John Grisham.
In Europe, parallel trade (what we call “importationâ€) is legal between all 25 EU member states. And last year 140 million individual drug packages were parallel imported throughout the European Union — and a wholesaler repackaged each and every one. This means that, literally, parallel traders open 140 million packets of drugs, remove their contents and repackage them. But these parallel profiteers are in the moneymaking business, not the safety business. And mistakes happen. For example, new labels incorrectly state the dosage strength; the new label says the box contains tablets, but inside are capsules; the expiration date and batch numbers on the medicine boxes don’t match the actual batch and dates of expiration of the medicines inside; and patient information materials are often in the wrong language or are out of date. Oops.
This means that drugs purchased from a British pharmacy to an unknowing American consumer (or a blissfully ignorant member of the United States Congress) could come from European Union nations such as Greece, Latvia, Poland, Malta, Cyprus, or Estonia. In fact, parallel traded medicines account for about 20% (one in five) of all prescriptions filled by the same British pharmacies that have had a record number of counterfeit recalls in 2006. And Pharmaceutish Weekblad, a respected pharmacy journal in the Netherlands, recently reported that counterfeit medicines found in the Netherlands at the end of last year entered the legitimate supply chain through parallel importers. Stubborn facts.
In the EU there is no requirement to record the batch numbers of parallel imported medicines, so if a batch of medicines originally intended for sale in Greece is recalled, tracing where the entire batch has gone (for example, from Athens to London through Canada to Indianapolis) is impossible. And all the large "legitimate" Canadian internet pharmacies already admit to getting their supplies from Europe. (An interesting and important side note is that these EU-sourced drugs aren't even legal for sale in Canada. So those folks who say we'll be getting "the same drugs as Canadians" are just plain wrong.) Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
The World Health Organization (WHO) estimates that 8-10% of the global medicine supply chain is counterfeit — rising to 25% or higher in some countries. The largest counterfeit market with close proximity to the EU free trade zone is Russia, where the generally accepted estimate is that 12% of drugs are counterfeit. Now that the Baltic nations of Latvia, Lithuania, and Estonia have joined the European Union, WHO has warned that an increase in the risks of counterfeits entering the EU supply chain is “obvious.†Facts are stubborn things.
According to Sue Mitchell, editor of the British journal Epilepsy Today, “The parallel trade in medication is damaging people’s health and, at worse, putting lives at risk. Strong words, but when the discussion of the parallel importing of medication seems to revolve primarily around money, the reality of patient experience goes unheard all too often.â€
Mr. Emanuel, Ms. Emerson, Senator Dorgan, Senator Snowe -- my 18-year old son has epilepsy. Please pay attention to the facts – and leave the fiction to John Grisham.
Having a slow morning? Today at 10:30 a.m., U.S. Representative Rahm Emanuel (D-IL) will announce bipartisan legislation aimed at “driving down the price of prescription drugs.†The Pharmaceutical Market Access and Drug Safety Act will be cosponsored in the House of Representatives by U.S. Representative Jo Ann Emerson (R-MO) and in the United States Senate by Senators Byron Dorgan (D-ND) and Olympia Snowe (R-ME).
So, you’d expect that these fine legislators to have a solid track record against protectionism, right? Nope.
Senator Olympia Snowe (R-ME) fiercely protects against cheap imports from foreign countries when they negatively affects constituencies in her backyard. She supported the US Government’s findings that softwood lumber imports from Canada were subsidized and unfairly priced. “The implementation of the softwood lumber agreement this morning brings a successful resolution to a long and often difficult dispute,†Senator Snowe said. “This agreement levels the playing field for the softwood lumber industry and brings an end to the unfair subsidizing of the Canadian lumber industry that had threatened thousands of softwood lumber industry jobs in Maine.â€
What about unfairly negotiated foreign prices for on-patent pharmaceuticals. Nope.
Senator Byron Dorgan (D-ND) is normally a staunch protectionist. Similar to Senator Snowe, Senator Dorgan staunchly defended the wheat farmers in North Dakota against subsidized imports of wheat from Canada. He went as far as to give Prairie Home Companion-worthy testimony about a family farmer at a recent Congressional hearing. He said, “The question for the "government," it seems to me that is posed by Kevin Neece and others is will someone finally stand up for family producers, for family farmers in this country and insist and demand unfair trade and insist and demand that our trading partners, in this instance Canada, comply with fair trade rules and comply with the agreements that were reached.â€
What about unfairly negotiated foreign prices for on-patent pharmaceuticals that unfairly place the financial burden of R&D on the American health care consumer? Nada.
And the leader of the pack, Rahm Emanuel (D-IL), supported the Byrd Amendment. When the Deficit Reduction Act of 2005 was passed, he co-wrote a dissenting opinion that stated: “Ensuring fair trade enables U.S. manufacturers and their workers to make continued investments to preserve their global competitiveness.â€
What about unfair European trade practices that threaten pharmaceutical companies with patent expropriation if they don’t accept absurdly low “reference prices†for new and innovative products? Zilch.
But who needs consistency when you’ve got sound bites?
So, you’d expect that these fine legislators to have a solid track record against protectionism, right? Nope.
Senator Olympia Snowe (R-ME) fiercely protects against cheap imports from foreign countries when they negatively affects constituencies in her backyard. She supported the US Government’s findings that softwood lumber imports from Canada were subsidized and unfairly priced. “The implementation of the softwood lumber agreement this morning brings a successful resolution to a long and often difficult dispute,†Senator Snowe said. “This agreement levels the playing field for the softwood lumber industry and brings an end to the unfair subsidizing of the Canadian lumber industry that had threatened thousands of softwood lumber industry jobs in Maine.â€
What about unfairly negotiated foreign prices for on-patent pharmaceuticals. Nope.
Senator Byron Dorgan (D-ND) is normally a staunch protectionist. Similar to Senator Snowe, Senator Dorgan staunchly defended the wheat farmers in North Dakota against subsidized imports of wheat from Canada. He went as far as to give Prairie Home Companion-worthy testimony about a family farmer at a recent Congressional hearing. He said, “The question for the "government," it seems to me that is posed by Kevin Neece and others is will someone finally stand up for family producers, for family farmers in this country and insist and demand unfair trade and insist and demand that our trading partners, in this instance Canada, comply with fair trade rules and comply with the agreements that were reached.â€
What about unfairly negotiated foreign prices for on-patent pharmaceuticals that unfairly place the financial burden of R&D on the American health care consumer? Nada.
And the leader of the pack, Rahm Emanuel (D-IL), supported the Byrd Amendment. When the Deficit Reduction Act of 2005 was passed, he co-wrote a dissenting opinion that stated: “Ensuring fair trade enables U.S. manufacturers and their workers to make continued investments to preserve their global competitiveness.â€
What about unfair European trade practices that threaten pharmaceutical companies with patent expropriation if they don’t accept absurdly low “reference prices†for new and innovative products? Zilch.
But who needs consistency when you’ve got sound bites?
How about a little drugwonks self-congratulation.
According to Technorati (the folks who measure blog audience numbers) of the 55 million blogs out there, drugwonks.com has cracked the elite top 100,000. We're Number 92,165.
We try harder.
Thanks for being part of the ride. And stand by -- you ain't seen nothing yet.
According to Technorati (the folks who measure blog audience numbers) of the 55 million blogs out there, drugwonks.com has cracked the elite top 100,000. We're Number 92,165.
We try harder.
Thanks for being part of the ride. And stand by -- you ain't seen nothing yet.
The rapid scientific movement towards a biomarker for AD reminds me of what some in the anti-psychiatry movement -- those who would discourage and destroy efforts to screen our young for mental illness -- state when they assert " that what is called mental illness such as depression, bipolar disorder, and other anxiety problems are caused by a “chemical imbalance†in the brain -- of unknown origin – is an unproven hypothesis and little more than mere conjecture. .... There is no way that we can quantitatively measure the serotonin (or any other neurotransmitter) level in a living human’s brain. Hence there can be no benchmark correct balance.
Right..
I guess all of the following are just PR efforts by BIG PHARMA
Genetics of emotional regulation: the role of the serotonin transporter in neural function. Trends Cogn Sci. 2006 Apr;10(4):182-91. Epub 2006 Mar 10
Imaging genetics: perspectives from studies of genetically driven variation in serotonin function and corticolimbic affective processing. Biol Psychiatry. 2006 May 15;59(10):888-97. Epub 2006 Jan 25.
Functional neuroimaging of genetic variation in serotonergic neurotransmission. Genes Brain Behav. 2003 Dec;2(6):341-9.
I could go on and on....but the point is the attack on Zyprexa, SSRIs or other medicines is based on a belief, a fervent one, that medicine is not necessary, that it only the perfect capitalist instrument, a form of control that keeps the consumer permanmently compliant. I am not entering the Mothership for that discussion. By the same token, while people are entitled to their opinions but they are not entitled to bully, threaten or intimidate me or anyone else.
Though diagnosis is not perfect, marketing is often mangled and manipulative, and medicines do have risks to describe medication as "drugging" and claiming schizophrenia is not a true disorder discourages effective treatment.
Right..
I guess all of the following are just PR efforts by BIG PHARMA
Genetics of emotional regulation: the role of the serotonin transporter in neural function. Trends Cogn Sci. 2006 Apr;10(4):182-91. Epub 2006 Mar 10
Imaging genetics: perspectives from studies of genetically driven variation in serotonin function and corticolimbic affective processing. Biol Psychiatry. 2006 May 15;59(10):888-97. Epub 2006 Jan 25.
Functional neuroimaging of genetic variation in serotonergic neurotransmission. Genes Brain Behav. 2003 Dec;2(6):341-9.
I could go on and on....but the point is the attack on Zyprexa, SSRIs or other medicines is based on a belief, a fervent one, that medicine is not necessary, that it only the perfect capitalist instrument, a form of control that keeps the consumer permanmently compliant. I am not entering the Mothership for that discussion. By the same token, while people are entitled to their opinions but they are not entitled to bully, threaten or intimidate me or anyone else.
Though diagnosis is not perfect, marketing is often mangled and manipulative, and medicines do have risks to describe medication as "drugging" and claiming schizophrenia is not a true disorder discourages effective treatment.
First Andy. Now Randy. And that's just dandy.
Randall Lutter Appointed Acting Deputy Commissioner for Policy
Dr. Andrew von Eschenbach, Commissioner of Food and Drugs (FDA), today announced that Randall Lutter, Ph.D., will serve as Acting Deputy Commissioner for Policy. Lutter will be replacing Dr. Scott Gottlieb who recently announced his resignation, effective late January 2007.
In this role, Lutter will provide guidance and input on all agency matters and serve as lead advisor to the Commissioner on agency policy.
“Randy has played a key role in the development and implementation of many of the agency’s highest priority initiatives,†said Dr. von Eschenbach. “The leadership he has shown in his current position as Associate Commissioner for Policy and Planning will ensure not only a smooth transition but also continued success in carrying out this agency’s mission.â€
Lutter joined FDA in 2003 as Chief Economist in the Office of Planning and has most recently served as the Associate Commissioner of Policy and Planning where he coordinated the agency’s regulatory and administrative policies aimed at protecting and advancing the health of the public. In this capacity he has also served as a lead advocate for Administration, Department, and FDA policies and programs before the Congress and to the public, especially with respect to health risks associated with importation of drugs and challenges controlling counterfeit drugs.
Before joining FDA Lutter was a resident scholar with the American Enterprise Institute and fellow with the AEI-Brookings Joint Center for Regulatory Studies. From 1991 to 1997 he served at the Office of Management and Budget in the Office of Information and Regulatory Affairs and from 1997 to 1998 he was senior economist for regulation and the environment at the President’s Council of Economic Advisers.
Lutter is a graduate of Cornell University where he earned a Ph.D. and M.A. in Economics.
Randall Lutter Appointed Acting Deputy Commissioner for Policy
Dr. Andrew von Eschenbach, Commissioner of Food and Drugs (FDA), today announced that Randall Lutter, Ph.D., will serve as Acting Deputy Commissioner for Policy. Lutter will be replacing Dr. Scott Gottlieb who recently announced his resignation, effective late January 2007.
In this role, Lutter will provide guidance and input on all agency matters and serve as lead advisor to the Commissioner on agency policy.
“Randy has played a key role in the development and implementation of many of the agency’s highest priority initiatives,†said Dr. von Eschenbach. “The leadership he has shown in his current position as Associate Commissioner for Policy and Planning will ensure not only a smooth transition but also continued success in carrying out this agency’s mission.â€
Lutter joined FDA in 2003 as Chief Economist in the Office of Planning and has most recently served as the Associate Commissioner of Policy and Planning where he coordinated the agency’s regulatory and administrative policies aimed at protecting and advancing the health of the public. In this capacity he has also served as a lead advocate for Administration, Department, and FDA policies and programs before the Congress and to the public, especially with respect to health risks associated with importation of drugs and challenges controlling counterfeit drugs.
Before joining FDA Lutter was a resident scholar with the American Enterprise Institute and fellow with the AEI-Brookings Joint Center for Regulatory Studies. From 1991 to 1997 he served at the Office of Management and Budget in the Office of Information and Regulatory Affairs and from 1997 to 1998 he was senior economist for regulation and the environment at the President’s Council of Economic Advisers.
Lutter is a graduate of Cornell University where he earned a Ph.D. and M.A. in Economics.
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.
