This week is particularly quiet with the Memorial Day holiday in the U.S. No events to report.
My computer difficulties persist and it will be a little longer before I get regular access.
Monday, May 28, 2007
Tuesday, May 22, 2007
Doctor Data and Pharmaceutical Costs
For the last few months, I’ve been pondering the linkage between perceptions of rising pharmaceutical costs and doctor data. Those arguing for physician secrecy continue to claim that data=increased costs. This argument was even used in a Washington Post story today on the topic.
So when the judge in New Hampshire came out with his 54-page ruling, I thought we might, at long last, get a glimpse of the evidence that physician data used for drug safety and marketing purposes drives costs. Guess what? It wasn’t there.
Every media story written on this topic, including today’s Washington Post, has mentioned the link between data and costs. Usually, it is Cindy Rosenwald delivering the message (the woman who introduced the bill in New Hampshire because her husband did not want anyone to know what he was doing). However, other stories have utilized the services of Sharon Treat (who, along with two or three friends, poses as a group called the National Litigation Association on Prescription Drug Prices) and various State Attorneys’ General. Case in point is an article in the May 4, 2007 issue of Modern Health, “The state has a substantial interest in protecting the privacy of New Hampshire physicians, defending the sanctity of the doctor-patient relationship and reducing healthcare costs," said Attorney General Kelly Ayotte in a written statement Thursday. New Hampshire Attorney General Kelly Ayotte can be forgiven for her ignorance on the topic since she didn’t handle the case personally, opting to let Assistant Attorney General Dick Head handle matters.
Not surprisingly, repeated attempts to speak with or obtain comment from Cindy Rosenwald and Sharon Treat have been ignored. On several occasions over the last few months, I have offered them the opportunity to present ANY evidence that I would include in this article. Rosenwald and Treat have both ignored e-mails and a woman hung up on me last week at a phone number listed for the Rosenwald with the New Hampshire Legislature. I can only assume that this is because they know there is no evidence supporting their position. I guess my only option is to ambush Rosenwald at one of the many conferences she is speaking (a la Michael Moore style).
So when the judge in New Hampshire came out with his 54-page ruling, I thought we might, at long last, get a glimpse of the evidence that physician data used for drug safety and marketing purposes drives costs. Guess what? It wasn’t there.
Every media story written on this topic, including today’s Washington Post, has mentioned the link between data and costs. Usually, it is Cindy Rosenwald delivering the message (the woman who introduced the bill in New Hampshire because her husband did not want anyone to know what he was doing). However, other stories have utilized the services of Sharon Treat (who, along with two or three friends, poses as a group called the National Litigation Association on Prescription Drug Prices) and various State Attorneys’ General. Case in point is an article in the May 4, 2007 issue of Modern Health, “The state has a substantial interest in protecting the privacy of New Hampshire physicians, defending the sanctity of the doctor-patient relationship and reducing healthcare costs," said Attorney General Kelly Ayotte in a written statement Thursday. New Hampshire Attorney General Kelly Ayotte can be forgiven for her ignorance on the topic since she didn’t handle the case personally, opting to let Assistant Attorney General Dick Head handle matters.
Not surprisingly, repeated attempts to speak with or obtain comment from Cindy Rosenwald and Sharon Treat have been ignored. On several occasions over the last few months, I have offered them the opportunity to present ANY evidence that I would include in this article. Rosenwald and Treat have both ignored e-mails and a woman hung up on me last week at a phone number listed for the Rosenwald with the New Hampshire Legislature. I can only assume that this is because they know there is no evidence supporting their position. I guess my only option is to ambush Rosenwald at one of the many conferences she is speaking (a la Michael Moore style).
Sunday, May 20, 2007
The Week Ahead – May 21-27
May 20-23 – National Minority AIDS Council is presenting a summit, "The Changing Landscape of HIV/AIDS: Rising to the Challenge."
May 21 – Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) is holding a meeting of the Medicare Program, Practicing Physicians Advisory Council to discuss certain proposed changes in regulations and manual instructions related to physicians' services.
May 22 – CMS presents the next Physicians, Nurses, and Allied Health Professionals Open Door Forum. The Physicians, Nurses, and Allied Health Professionals Open Door Forum (ODF) addresses the concerns and issues of Medicare and Medicaid physicians, non-physician practitioners, nurses, and other allied health care specialists. This diverse group of providers serves Medicare and Medicaid beneficiaries in almost all service settings, ranging from independent physician offices to specialized departments within larger facilities. The types of issues that come up during this forum are as varied as the providers who participate, but some frequent topics include the Physician Fee Schedule, Stark regulations, care plan oversight, payment and documentation rules, Provider Enrollment Chain Ownership System (PECOS), as well as the roles and responsibilities of different allied health professional staff under CMS regulations.
May 22 – Avalere Health is presenting "Evidence-based Medicine/Set Your Sights,” at the Mandarin Oriental Hotel Washington, D.C. Recent developments in evidence-based medicine are generating a wave of transformation in healthcare – are you ready to take it on? Join experts from government, industry, and academia to discuss the latest trends in value-based purchasing, comparative effectiveness, and insurance coverage decision-making. Find out how developments in EBM may further influence product commercialization strategy, how to engage in the redefinition of the clinical research enterprise, and whether payment reform will include paying for quality improvement.
May 22 – NIH-FDA, Chinese American Association is hosting a Lecture, "Perspectives on Global Health."
May 21 – Health and Human Services Department (HHS); Centers for Medicare & Medicaid Services (CMS) is holding a meeting of the Medicare Program, Practicing Physicians Advisory Council to discuss certain proposed changes in regulations and manual instructions related to physicians' services.
May 22 – CMS presents the next Physicians, Nurses, and Allied Health Professionals Open Door Forum. The Physicians, Nurses, and Allied Health Professionals Open Door Forum (ODF) addresses the concerns and issues of Medicare and Medicaid physicians, non-physician practitioners, nurses, and other allied health care specialists. This diverse group of providers serves Medicare and Medicaid beneficiaries in almost all service settings, ranging from independent physician offices to specialized departments within larger facilities. The types of issues that come up during this forum are as varied as the providers who participate, but some frequent topics include the Physician Fee Schedule, Stark regulations, care plan oversight, payment and documentation rules, Provider Enrollment Chain Ownership System (PECOS), as well as the roles and responsibilities of different allied health professional staff under CMS regulations.
May 22 – Avalere Health is presenting "Evidence-based Medicine/Set Your Sights,” at the Mandarin Oriental Hotel Washington, D.C. Recent developments in evidence-based medicine are generating a wave of transformation in healthcare – are you ready to take it on? Join experts from government, industry, and academia to discuss the latest trends in value-based purchasing, comparative effectiveness, and insurance coverage decision-making. Find out how developments in EBM may further influence product commercialization strategy, how to engage in the redefinition of the clinical research enterprise, and whether payment reform will include paying for quality improvement.
May 22 – NIH-FDA, Chinese American Association is hosting a Lecture, "Perspectives on Global Health."
Saturday, May 19, 2007
J&J’s Movie InnerState
I was finally got to see the Johnson & Johnson/Centocor movie InnerState. Wow!
While I had mentioned this movie before in Johnson and Johnson Makes Patient-Education Movie, I really wanted to wait to see it before fully commenting – unlike ignorant pundits such as Jerry Avorn who spewed forth venomous comments without having seen it. This is not DTC advertising!
This movie should be mandatory viewing for every physician in America – whether they treat patients with Crohn’s, psoriasis and rheumatoid arthritis or not. All too often, physicians are willing to separate the clinical encounter from the patient’s life. Doctors tend to ignore the emotional impact of diseases – and InnerState is a wake-up call.
The film profiles three patients – one with RA, one with Crohn’s and one with psoriasis – and the daily struggles they go through with their diseases. The patient’s tears are real. These aren’t actors playing them or their families, it’s the real reality. The stories are very powerful.
One patient, Jason, really struck home for me. He tells the story of going to a swimming pool with psoriasis and being treated like a leper and watching parents pull their kids out of the pool. He says: “It’s not communicable, it’s not life-threatening – It’s certainly life altering.”
Johnson & Johnson has a long history these kind of broader issues-based campaigns. Since the J&J product, Remicade, is never mentioned in the film and no treatment option is pushed (contrary to Avorn’s comments that this is a “commercial”), it’s not clear if J&J is thinking of InnerState as an issues campaign or if this is more traditional product push. The movie has received considerable media attention and is currently on a nation-wide tour.
The film is very compelling as a documentary and certainly worth the hour for the human interest angle. Doctors need to see this film.
While I had mentioned this movie before in Johnson and Johnson Makes Patient-Education Movie, I really wanted to wait to see it before fully commenting – unlike ignorant pundits such as Jerry Avorn who spewed forth venomous comments without having seen it. This is not DTC advertising!
This movie should be mandatory viewing for every physician in America – whether they treat patients with Crohn’s, psoriasis and rheumatoid arthritis or not. All too often, physicians are willing to separate the clinical encounter from the patient’s life. Doctors tend to ignore the emotional impact of diseases – and InnerState is a wake-up call.
The film profiles three patients – one with RA, one with Crohn’s and one with psoriasis – and the daily struggles they go through with their diseases. The patient’s tears are real. These aren’t actors playing them or their families, it’s the real reality. The stories are very powerful.
One patient, Jason, really struck home for me. He tells the story of going to a swimming pool with psoriasis and being treated like a leper and watching parents pull their kids out of the pool. He says: “It’s not communicable, it’s not life-threatening – It’s certainly life altering.”
Johnson & Johnson has a long history these kind of broader issues-based campaigns. Since the J&J product, Remicade, is never mentioned in the film and no treatment option is pushed (contrary to Avorn’s comments that this is a “commercial”), it’s not clear if J&J is thinking of InnerState as an issues campaign or if this is more traditional product push. The movie has received considerable media attention and is currently on a nation-wide tour.
The film is very compelling as a documentary and certainly worth the hour for the human interest angle. Doctors need to see this film.
Wednesday, May 16, 2007
Private Equity Grabs Bausch & Lomb
Bausch & Lomb took steps to be purchased by a private equity group headed by Warburg Pincus. According to the press release, the deal is valued at $4.5 billion, with about a quarter coming from new debt. Rumors have been circling on Bausch & Lomb for weeks, so today’s announcement was more formality.
Bausch & Lomb has about two months to solicit better offers before the deal closes.
Bausch & Lomb has about two months to solicit better offers before the deal closes.
A New Look at Autism (and Thimerosal)
A new AP story out yesterday, based on an April report from the Centers for Disease Control and Prevention (CDC) and the Interdisciplinary Council on Developmental and Learning Disorders, found that autism can be diagnosed in children before the age of 1 year.
What is most interesting about this AP story as well as the CDC report is that these children are often immunization-naive. They have not yet received vaccinations, much less vaccinations containing thiomersal/thimerosal. While the belief that thimerosal is the root cause of all cases of autism still persists in parental circles, this study would appear to undermine those assertions. How can thimerosal cause autism in patients that haven’t been vaccinated?
This study would seem to be the latest evidence in a long-string of studies disproving the popular thimerosal-autism myth/belief. Even some studies funded by proponents of the thimerosal-autism myth have been able to only demonstrate concurrence, not causality.
Since 2002, thiomersal/thimerosal is being phased out of pediatric vaccines in the United States. However, if the assertions of groups supporting this idea are correct, you would begin to see a decline in autism diagnosis over the last few years as thimerosal usage is scaled back. That hasn’t happened. Quite the opposite seems to be true – autism incidence continues to increase.
Now, I’m not going to argue that thimerosal might actually protect against autism (making absurd claims of causality based on limited observations led to the rise of the thimerosal myth in the first place). However, if we do not begin to see noticeable declines autism rates in the U.S. soon, it would seriously challenge the credibility of the groups advancing these ideas.
What is most interesting about this AP story as well as the CDC report is that these children are often immunization-naive. They have not yet received vaccinations, much less vaccinations containing thiomersal/thimerosal. While the belief that thimerosal is the root cause of all cases of autism still persists in parental circles, this study would appear to undermine those assertions. How can thimerosal cause autism in patients that haven’t been vaccinated?
This study would seem to be the latest evidence in a long-string of studies disproving the popular thimerosal-autism myth/belief. Even some studies funded by proponents of the thimerosal-autism myth have been able to only demonstrate concurrence, not causality.
Since 2002, thiomersal/thimerosal is being phased out of pediatric vaccines in the United States. However, if the assertions of groups supporting this idea are correct, you would begin to see a decline in autism diagnosis over the last few years as thimerosal usage is scaled back. That hasn’t happened. Quite the opposite seems to be true – autism incidence continues to increase.
Now, I’m not going to argue that thimerosal might actually protect against autism (making absurd claims of causality based on limited observations led to the rise of the thimerosal myth in the first place). However, if we do not begin to see noticeable declines autism rates in the U.S. soon, it would seriously challenge the credibility of the groups advancing these ideas.
Monday, May 14, 2007
Physicians Refuse Disclosure of Major Medical Errors
Researchers at the University of Iowa’s Carver College of Medicine reported last week that doctors do not disclose to patients when they make a mistake. Lauris Kaldijan and colleagues tested physicians who said they would disclose a medical error to see if they actually do so.
The findings—
The findings—
- 97% of physicians said they would disclose an error that caused the patient minor harm, however, in practice, just 41% did so
- 93% of physicians said they would disclose an error that caused major harm or death, however, in practice, just a scant 5% actually did so
Merck KGaA Sells Generics Biz
And the winner is... Mylan Laboratories. Sale price is 4.9 billion euros ($6.6 billion). The book value on the business is less than 1 billion euros. Speculating is already flying that Mylan probably overpaid (not unlike AstraZeneca’s recent purchase of MedImmune).
The Merck KGaA-Mylan deal is subject to regulatory approval in Europe, which is likely, but by no means assured. The deal won’t close until later in the year. Merck KGaA needs the cash to pay off the massive debt it incurred in buying the Swiss biotech company, Serono.
Merck KGaA had the generics biz up for sale for over six months. At one point, it was a six-way horserace with Mylan, Teva and Actavis all in the running with strong bids. This allows Mylan to become a global generics company overnight.
The Merck KGaA-Mylan deal is subject to regulatory approval in Europe, which is likely, but by no means assured. The deal won’t close until later in the year. Merck KGaA needs the cash to pay off the massive debt it incurred in buying the Swiss biotech company, Serono.
Merck KGaA had the generics biz up for sale for over six months. At one point, it was a six-way horserace with Mylan, Teva and Actavis all in the running with strong bids. This allows Mylan to become a global generics company overnight.
The Week Ahead – May 14-20
May 14 – CMS is hosting a forum on “Registry-based Reporting for the Physician Quality Reporting Initiative” in Baltimore.
May 14 – The Advanced Medical Technology Assn. is sponsoring their Annual Medical Technology Fair focusing on progress in the field of diabetes care. Participants include Rep. Michael Castle (R-DE); Gary Hall Jr., Olympic gold medal swimmer with Type 1 Diabetes, and spokesperson for the BD Diabetes Makeover Program; Nicole Johnson, Miss America 1999 and diabetes advocate; and Stephen Ubl, president and CEO of AdvaMed.
May 14 – The National Committee to Preserve Social Security and Medicare is having a policy briefing for Congressional staff and media on "Cutting Social Security Benefits: What's in Your Wallet?" including a discussion of the new National Academy of Social Insurance report, "Social Security and Retirement Income Adequacy." The participants include Former Rep. Barbara Kennelly (D-CT), president and CEO, National Committee to Preserve Social Security and Medicare; Virginia Reno, vice president for income security, National Academy of Social Insurance; and Nancy Altman, Social Security Expert.
May 14 – Centers for Medicare and Medicaid Services, is presenting “Healthcare Special ODF: Registry-based Reporting for the Physician Quality Reporting Initiative (PQRI).”
May 15 – Senate Health, Education, Labor and Pensions Committee on Alzheimer’s Research is holding a Retirement and Aging Subcommittee hearing on “Alzheimer’s Disease: Current and Future Breakthrough Research.”
May 15 – The American Stroke Assn. is having a briefing titled “STOP Stroke: Improving the Quality of Stroke Care.” Tedy Bruschi, stroke survivor and NFL linebacker for the New England Patriots.
May 15 – Centers for Medicare and Medicaid Services, is presenting “Healthcare Common Procedure Coding System (HCPCS) Public Meetings.” The purpose of the Public Meetings is to provide a forum for the general public to present information regarding specific Healthcare Common Procedural Coding System (HCPCS) coding requests for new products, supplies, and services. The meeting also provides an opportunity to obtain industry and public reaction to the preliminary coding recommendations of the CMS HCPCS Workgroup, as well as CMS’ preliminary recommendations regarding payment methodology. Coding decisions related to the Medicare and Medicaid programs internal operating procedures are reviewed internally, and are not included in this forum.
May 15 – House Ways and Means Committee is conducting a hearing concerning Medicare Provider Payments. Health Subcommittee hearing on “Payments to Certain Medicare Fee-for-Service Providers.”
May 16 – Senate Judiciary Committee is holding a full committee hearing on "Rogue Online Pharmacies: The Growing Problem of Internet Drug Trafficking." Participants include Francine Haight, founder of Ryan's Cause, Laguna Niguel, Calif.; Joseph Rannazzisi, deputy assistant administrator of the Office of Diversion Control at the Drug Enforcement Administration; Joseph Califano Jr., chairman and president of the National Center on Addiction and Substance Abuse at Columbia University and former secretary of Health, Education and Welfare; Philip Heymann, professor of law at Harvard Law School and former deputy U.S. Attorney General; and Thomas McClellan, executive director of the Treatment Research Institute at the University of Pennsylvania.
May 16 –National Health IT Week 2007 kicks off in Washington. Included in the discussions Rep. Patrick Kennedy (D-RI) and Rep. Phil Gingrey (R-GA) David Roberts, vice president for government relations of the Healthcare Information and Management Systems Society (HIMSS); and Hugh Zettel, vice chairman of the Electronic Health Record Vendors Assn. and director of government and industry relations at GE Healthcare.
May 16-17 – Health and Human Services Department (HHS); Food and Drug Administration (FDA) is hosting a meeting of the Vaccines and Related Biological Products Advisory Committee to receive presentations and make recommendations on the safety and effectiveness of influenza virus vaccine live (FluMist from MedImmune) in a pediatric population less than 59 months of age; and hear an overview of the function of the Laboratory of Bacterial Polysaccharides and the Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial Parasitic and Allergenic Products, Office of Vaccines Research and Review.
May 16-17 – Health and Human Services Department (HHS); Office of Public Health and Science is having a meeting of the Chronic Fatigue Syndrome Advisory Committee.
May 17 – Society for Women’s Health Research and National Osteoporosis Foundation is sponsoring a Congressional briefing with actress Sally Field to increase awareness for osteoporosis screening and prevention.” A panel of experts will present information on advances in the prevention and treatment of osteoporosis. Actress Sally Field, an osteoporosis patient and advocate, will talk about her experience with the disease.
May 19 – FDA Research Review Subcommittee of the Vaccines and Related Biological Products Advisory Committee.
Sunday, May 13, 2007
Combination Drugs Better for Treating Heart Disease
A study presented at Friday's American Heart Association (AHA) 8th Scientific Forum on Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke demonstrates that combination therapy may be more effective than two different pills for reducing heart disease risk factors (Abstract 173). The study of atorvastatin (Lipitor) with amlodipine (Norvasc) should superior reduction in risk events compared to both medications being taken independently.
The single tablet (Caduet) is less costly than the two-tablet combination. Medical costs over four years were $7,665 for the two-tablet regimen and $6,471 for the one-tablet regimen. The study also demonstrated that it was at least as effective, and perhaps more so than the two-pill regimen.
“This is a novel research approach that examines the economic and clinical implications of high blood pressure and cholesterol in the real world,” said Timothy W. Smith, lead author of the study and senior director of Informatics for ValueMedics Research (a unit of IMS Health Inc), a health outcomes research and consulting firm in Falls Church, VA.
Pharma companies really need to do a better job of demonstrating the value of their products. While this is a study of combination vs. dual-tablets, companies need to do a better job of showing that pharmacotherapy reduces expenses in other parts of the health care system.
The single tablet (Caduet) is less costly than the two-tablet combination. Medical costs over four years were $7,665 for the two-tablet regimen and $6,471 for the one-tablet regimen. The study also demonstrated that it was at least as effective, and perhaps more so than the two-pill regimen.
“This is a novel research approach that examines the economic and clinical implications of high blood pressure and cholesterol in the real world,” said Timothy W. Smith, lead author of the study and senior director of Informatics for ValueMedics Research (a unit of IMS Health Inc), a health outcomes research and consulting firm in Falls Church, VA.
Pharma companies really need to do a better job of demonstrating the value of their products. While this is a study of combination vs. dual-tablets, companies need to do a better job of showing that pharmacotherapy reduces expenses in other parts of the health care system.
Post-BIO Withdrawal
Last week got away from me. BIO was hectic, as always. And then Pharm Aid went straight into the American Heart Association Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Conference 2007 in Washington.
More on these topics coming soon.
More on these topics coming soon.
Wednesday, May 9, 2007
FDA Committee Declines to Back IDM Pharma’s Junovan
An FDA Advisory Committee panel declined to back IDM Pharma’s drug Junovan (mifamurtide) citing confusing clinical trial results. Junovan would be used to treat osteosarcoma in patients who have already undergone surgery and chemotherapy. The product is marketed as Mepact in Europe.
The 12-2 vote by the committee puts Junovan’s future in doubt, although the FDA gets final authority. Earlier in the week, an FDA staff report said Junovan was not effective. The report also indicated the study had flaws that could have been addressed with the FDA, but the company failed to do engage the agency.
Junovan would be the first new therapy for osteosarcoma, a rare childhood bone cancer, in nearly two decades. About 1,000 children are afflicted with the disease each year.
The 12-2 vote by the committee puts Junovan’s future in doubt, although the FDA gets final authority. Earlier in the week, an FDA staff report said Junovan was not effective. The report also indicated the study had flaws that could have been addressed with the FDA, but the company failed to do engage the agency.
Junovan would be the first new therapy for osteosarcoma, a rare childhood bone cancer, in nearly two decades. About 1,000 children are afflicted with the disease each year.
Tuesday, May 8, 2007
Dispatches from BIO – Tough Love and Jihad
Jihad in Beantown 
Jordan’s Queen Noor mandated that all media be barred from her keynote address earlier today (and the BIO Executive Committee caved). The media censorship has rubbed a lot of people the wrong way and her presence has caused a number of logistical headaches with security (you thought Bill Clinton was bad last year). Ed Silverman/Pharmalot has suggested BIO hold next year’s convention in Tehran. Ed, don’t give them any more ideas.
A more blunt description of the media censorship can be found at Pharmalot in BIO: Is This Boston, Or The Mideast?
Tough Love
Michael J. Fox took the tough love approach with the BIO crowd challenging them on not doing more in terms of Parkinsons research. Fox forgot to not the rock the boat when he’s sitting in it since his foundation is a major researcher in this space. Fox also got a little confused at one point when he credited the audience for developing antidepressants for dogs (that was Eli Lilly, not a biotech firm).
Missing in Action
Senator Edward Kennedy (D-MA) flaked out on at the last minute to stay in Washington to babysit his FDA overhaul legislation. The HD video replacement didn’t do him justice. We missed you Teddy! Enjoy a drink on us…
Jordan’s Queen Noor mandated that all media be barred from her keynote address earlier today (and the BIO Executive Committee caved). The media censorship has rubbed a lot of people the wrong way and her presence has caused a number of logistical headaches with security (you thought Bill Clinton was bad last year). Ed Silverman/Pharmalot has suggested BIO hold next year’s convention in Tehran. Ed, don’t give them any more ideas.A more blunt description of the media censorship can be found at Pharmalot in BIO: Is This Boston, Or The Mideast?
Tough LoveMichael J. Fox took the tough love approach with the BIO crowd challenging them on not doing more in terms of Parkinsons research. Fox forgot to not the rock the boat when he’s sitting in it since his foundation is a major researcher in this space. Fox also got a little confused at one point when he credited the audience for developing antidepressants for dogs (that was Eli Lilly, not a biotech firm).
Missing in Action
Senator Edward Kennedy (D-MA) flaked out on at the last minute to stay in Washington to babysit his FDA overhaul legislation. The HD video replacement didn’t do him justice. We missed you Teddy! Enjoy a drink on us…
I’ve got a lot more to say on Thailand and patents, but want to do the topic justice.
Senate Says “Not Yet to Drug Imports”
Yesterday, the Senate passed the Thad Cochran (R-MS) amendment to the drug import law which requires the FDA to certify both the safety and effectiveness of imported drugs. The amendment passed on a 49-40 vote and was tacked on Senator Byron Dorgan’s (D-ND) S.242 drug importation bill. However, the Dorgan bill did pass with this amendment. (See previous discussion in Senate Poised to Green Light Drug Imports)
The Dorgan bill, being called the Senior Citizen Death Act of 2007 by some in Washington, would allow for legal imports of prescription drugs that manufactured in Canada, Australia, Europe, Japan and New Zealand – all developed countries. However the Dorgan bill was weak on safeguards and wouldn’t prevent drugs manufactured in countries like China (with its rash of counterfeits) and other countries from leaking into the U.S. system.
Senator Mike Enzi (R-WY) supported the Cochran amendment and said, "Under both Democratic and Republican administrations, secretaries of Health and Human Services have declined to certify that foreign drugs _ like those allowed under the Dorgan Foreign Drug Act _ are safe for American consumers. They realized, as I do, that close enough isn't good enough."
The Dorgan bill, being called the Senior Citizen Death Act of 2007 by some in Washington, would allow for legal imports of prescription drugs that manufactured in Canada, Australia, Europe, Japan and New Zealand – all developed countries. However the Dorgan bill was weak on safeguards and wouldn’t prevent drugs manufactured in countries like China (with its rash of counterfeits) and other countries from leaking into the U.S. system.
Senator Mike Enzi (R-WY) supported the Cochran amendment and said, "Under both Democratic and Republican administrations, secretaries of Health and Human Services have declined to certify that foreign drugs _ like those allowed under the Dorgan Foreign Drug Act _ are safe for American consumers. They realized, as I do, that close enough isn't good enough."
Nobody is disputing that safe medications can be found in these other countries. However, the difficulty in keeping the unsafe medications out of the U.S. far outweighs any possible benefit that could be enjoyed.
More on the topic in The Realities of Importation and Senate Backing Importation.
Hat tip: Adam Fein at Drug Channels.
Senate Takes on DTC Advertising
The Senate is expected to take on DTC Advertising this week as part of the Kennedy-Enzi Drug Safety Bill. What does DTC Advertising have to do with drug safety? Not much, but let’s not let that get in the way.
The Food and Drug Administration Revitalization Act (S.1082) sponsored by Senator Edward Kennedy (D-MA) and Sen. Michael Enzi (R-WY) would give the FDA the authority to ban DTC ads for up to two years and impose broad sanctions on the pharmaceutical industry. How exactly a two year delay in ads would benefit patients has not been made clear in the debates and no actual evidence has been presented. A lot of energy is going into this DTC ad issue and opponents of the industry love to finger them as a problem because they get patients involved in the healthcare decision-making process (ground that was exclusively the physician’s domain).
The Food and Drug Administration Revitalization Act (S.1082) sponsored by Senator Edward Kennedy (D-MA) and Sen. Michael Enzi (R-WY) would give the FDA the authority to ban DTC ads for up to two years and impose broad sanctions on the pharmaceutical industry. How exactly a two year delay in ads would benefit patients has not been made clear in the debates and no actual evidence has been presented. A lot of energy is going into this DTC ad issue and opponents of the industry love to finger them as a problem because they get patients involved in the healthcare decision-making process (ground that was exclusively the physician’s domain).
When you don’t have a strong opinion, it is interesting to see how passionate people get about this issue.
Assuming this bill gets railroaded through Congress, I will miss the evening chats about Viagra, Cialis, Levitra and erections lasting longer than 4-8 hours. Although it should be noted that this is a watershed moment in American politics—a Kennedy taking a stand against erections.
Assuming this bill gets railroaded through Congress, I will miss the evening chats about Viagra, Cialis, Levitra and erections lasting longer than 4-8 hours. Although it should be noted that this is a watershed moment in American politics—a Kennedy taking a stand against erections.
Monday, May 7, 2007
Counterfeit Glycerin Floods Global Markets – Patients at Risk
As Congress takes up Senator Byron Dorgan’s (D-ND) S.242 which would allow for prescription drug importation today, the New York Times ran a startling story about drug safety. Drug counterfeiters in China are using diethylene glycol instead of the more expensive glycerin syrup. The Times reports that these counterfeit syrups have killed thousands of people in mass poisonings in several countries over the last 20 years.
According to the Times, “In China, the government is vowing to clean up its pharmaceutical industry, in part because of criticism over counterfeit drugs flooding the world markets. In December, two top drug regulators were arrested on charges of taking bribes to approve drugs. In addition, 440 counterfeiting operations were closed down last year, the World Health Organization said.” Yet, this crackdown is just scrapping the surface of a huge problem.
This is a timely story because of the ease of which of obtaining these tainted products through Internet pharmacies. Senator Dorgan’s bill will, unfortunately, open the doors to counterfeit drugs in the U.S. and harm patient safety.
This has been previously covered in the Realities of Importation, UN Report on Drug Counterfeiting and Counterfeit Drugs.
According to the Times, “In China, the government is vowing to clean up its pharmaceutical industry, in part because of criticism over counterfeit drugs flooding the world markets. In December, two top drug regulators were arrested on charges of taking bribes to approve drugs. In addition, 440 counterfeiting operations were closed down last year, the World Health Organization said.” Yet, this crackdown is just scrapping the surface of a huge problem.
This is a timely story because of the ease of which of obtaining these tainted products through Internet pharmacies. Senator Dorgan’s bill will, unfortunately, open the doors to counterfeit drugs in the U.S. and harm patient safety.
This has been previously covered in the Realities of Importation, UN Report on Drug Counterfeiting and Counterfeit Drugs.
Sunday, May 6, 2007
The Week Ahead – May 7-14
May 6-9 – BIO International Meeting in Boston. As a result, my postings will be a bit more sporadic this week.
May 7 – The George Washington University School of Public Health and Health Services is presenting a policy briefing on the implications of Medicaid's new citizenship and identification documentation requirements for health centers and their patients. Participants include Feygele Jacobs, executive vice president of the RCHN Community Health Foundation; Sara Rosenbaum, professor and chairman of the Department of Health Policy; Peter Shin, assistant research professor and director of the Geiger Gibson/RCHN Community Health Foundation Research Collaborative; and Dan Hawkins, vice president for federal, state and public affairs at the National Assn. of Community Health Centers, Inc.
May 8 – Senate Finance Committee is holding a full committee hearing on "The Medicare Prescription Drug Benefit: Review and Oversight." Participates include Abby Block, director of the Center for Beneficiary Choices in the Centers for Medicare and Medicaid Services at the Health and Human Services Department; Beatrice Disman, regional commissioner of Social Security for the New York Region, and chairman of the Medicare Planning and Implementation Task Force of the Social Security Administration, New York, N.Y.; and Kathleen King, director of health care at the Government Accountability Office.
May 8 – The Heritage Foundation is presenting “The Myth of Government Health Care.” The keynote speaker is John Stossel ABC News Correspondent, Co-Anchor of ABC’s Newsmagazine 20/20, and author of Myths, Lies, and Downright Stupidity: Get Out the Shovel – Why Everything You Know Is Wrong Hosted by Rebecca Hagelin Vice President, Communications and Marketing.
May 9 – House Energy and Commerce Committee is holding a Health Subcommittee hearing on "Assessing the Safety of our Nation's Drug Supply."
May 10 – Health and Human Services Department (HHS); Food and Drug Administration (FDA) is holding a meeting of the Oncologic Drugs Advisory Committee to discuss new drug application (NDA) 022-092, proposed trade name JUNOVAN (mifamurtide), IDM Pharma, Inc., proposed indication for the treatment of newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy; and to discuss NDA 022-062, proposed trade name ORBEC (beclomethasone dipropionate), DOR BioPharma, Inc., proposed indication for the treatment of graft versus host disease (GvHD) involving the gastrointestinal tract in conjunction with an induction course of high-dose prednisone or prednisolone.
May 10 – Health and Human Services Department (HHS); Food and Drug Administration (FDA) is having a meeting of the Oncologic Drugs Advisory Committee to discuss updated information on risks of erythropoeisis-stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.) for use in the treatment of anemia due to cancer chemotherapy.
May 10 – The National Economists Club is holding a luncheon discussion on "The Promise of Progressive Cost Consciousness in Healthcare Reform," with Jason Furman of the Brookings Institution. The sharing of health care costs through health savings accounts (HSAs) is unlikely to reduce total health care spending significantly. At the same time, it increases the financial and medical risks faced by low and moderate income families. Mr. Furman will discuss key economic issues in health care reform, including how more effective forms of cost sharing (income-related cost sharing, for example) could restrain health spending, improve the effectiveness of health spending, and insulate families from major financial risks.
May 7 – The George Washington University School of Public Health and Health Services is presenting a policy briefing on the implications of Medicaid's new citizenship and identification documentation requirements for health centers and their patients. Participants include Feygele Jacobs, executive vice president of the RCHN Community Health Foundation; Sara Rosenbaum, professor and chairman of the Department of Health Policy; Peter Shin, assistant research professor and director of the Geiger Gibson/RCHN Community Health Foundation Research Collaborative; and Dan Hawkins, vice president for federal, state and public affairs at the National Assn. of Community Health Centers, Inc.
May 8 – Senate Finance Committee is holding a full committee hearing on "The Medicare Prescription Drug Benefit: Review and Oversight." Participates include Abby Block, director of the Center for Beneficiary Choices in the Centers for Medicare and Medicaid Services at the Health and Human Services Department; Beatrice Disman, regional commissioner of Social Security for the New York Region, and chairman of the Medicare Planning and Implementation Task Force of the Social Security Administration, New York, N.Y.; and Kathleen King, director of health care at the Government Accountability Office.
May 8 – The Heritage Foundation is presenting “The Myth of Government Health Care.” The keynote speaker is John Stossel ABC News Correspondent, Co-Anchor of ABC’s Newsmagazine 20/20, and author of Myths, Lies, and Downright Stupidity: Get Out the Shovel – Why Everything You Know Is Wrong Hosted by Rebecca Hagelin Vice President, Communications and Marketing.
May 9 – House Energy and Commerce Committee is holding a Health Subcommittee hearing on "Assessing the Safety of our Nation's Drug Supply."
May 10 – Health and Human Services Department (HHS); Food and Drug Administration (FDA) is holding a meeting of the Oncologic Drugs Advisory Committee to discuss new drug application (NDA) 022-092, proposed trade name JUNOVAN (mifamurtide), IDM Pharma, Inc., proposed indication for the treatment of newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy; and to discuss NDA 022-062, proposed trade name ORBEC (beclomethasone dipropionate), DOR BioPharma, Inc., proposed indication for the treatment of graft versus host disease (GvHD) involving the gastrointestinal tract in conjunction with an induction course of high-dose prednisone or prednisolone.
May 10 – Health and Human Services Department (HHS); Food and Drug Administration (FDA) is having a meeting of the Oncologic Drugs Advisory Committee to discuss updated information on risks of erythropoeisis-stimulating agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen, Inc.) for use in the treatment of anemia due to cancer chemotherapy.
May 10 – The National Economists Club is holding a luncheon discussion on "The Promise of Progressive Cost Consciousness in Healthcare Reform," with Jason Furman of the Brookings Institution. The sharing of health care costs through health savings accounts (HSAs) is unlikely to reduce total health care spending significantly. At the same time, it increases the financial and medical risks faced by low and moderate income families. Mr. Furman will discuss key economic issues in health care reform, including how more effective forms of cost sharing (income-related cost sharing, for example) could restrain health spending, improve the effectiveness of health spending, and insulate families from major financial risks.
Friday, May 4, 2007
In Defense of Patents
The Brazilian Government has followed Thailand in announcing it will issue compulsory licenses for pharmaceutical products. In today’s announcement, Brazil will violate Merck’s patent on Stocrin (efavirenz), an HIV/AIDS medication.
Unlike Thailand, Brazil is not controlled by a rogue government that came to power through a military coup. And unlike Thailand, Bazil is an economic powerhouse – the world’s 12th largest economy. As a country, Brazil has the economic means to look after its population, but struggles to do so because of political corruption.
Thus far, the recent rash of patent violations (positioned as “compulsory licenses”) has been limited to HIV/AIDS medications. Countries unwilling to look at education, family planning and other means of heading off the disease find patent violations a convenient short-term political fix to the long-term health crisis. Compulsory licenses – at the bargaining table in Brazil or down the barrel of a gun in Thailand – will not fix the HIV/AIDS crisis in those countries. AIDS activists should look beyond these near-sighted government announcements and keep the pressure on the countries to enact meaningful, long-term AIDS prevention plans.
We can all acknowledge that these government actions appear to be for noble purposes (in the case of AIDS). However, expanding compulsory licenses beyond crisis situations to cover non-emergency situations, is concerning. Moreover, it shifts even more of the financial burden of R&D back onto citizens in countries like the U.S. Do we owe it to the world to shoulder the burden for their government’s corruption or their government’s unwillingness to take health situations like AIDS seriously?
Selfishly, I’m sorry people in Phuket and Rio have AIDS. But it is not my financial responsibility to underwrite their medical treatment.
Unlike Thailand, Brazil is not controlled by a rogue government that came to power through a military coup. And unlike Thailand, Bazil is an economic powerhouse – the world’s 12th largest economy. As a country, Brazil has the economic means to look after its population, but struggles to do so because of political corruption.
Thus far, the recent rash of patent violations (positioned as “compulsory licenses”) has been limited to HIV/AIDS medications. Countries unwilling to look at education, family planning and other means of heading off the disease find patent violations a convenient short-term political fix to the long-term health crisis. Compulsory licenses – at the bargaining table in Brazil or down the barrel of a gun in Thailand – will not fix the HIV/AIDS crisis in those countries. AIDS activists should look beyond these near-sighted government announcements and keep the pressure on the countries to enact meaningful, long-term AIDS prevention plans.
We can all acknowledge that these government actions appear to be for noble purposes (in the case of AIDS). However, expanding compulsory licenses beyond crisis situations to cover non-emergency situations, is concerning. Moreover, it shifts even more of the financial burden of R&D back onto citizens in countries like the U.S. Do we owe it to the world to shoulder the burden for their government’s corruption or their government’s unwillingness to take health situations like AIDS seriously?
Selfishly, I’m sorry people in Phuket and Rio have AIDS. But it is not my financial responsibility to underwrite their medical treatment.
Senate Poised to Green-Light Drug Imports
The Senate is on the verge of green-lighting a proposal that would enable the importation of prescription drugs from foreign countries. The legislation was introduced as an amendment to S.1082 by Senator Byron Dorgan (D-ND) and strongly supported by AARP. The Senate is expected to take up the measure on Monday, under a veto threat from President Bush.
Dorgan’s issue is that drug prices are higher in the U.S. than in other parts of the world. He told the AP, “That’s my beef. Their pricing policies are wrong.” Dorgan seems to forget that it is U.S. policy that has created this situation – U.S. researchers (at drug companies, NIH and academic research institutions) subsidize the entire drug development process for the rest of the world.
On small positive, The Wall Street Journal is noting that before the bill can be formally voted on, the Senate must consider an amendment by Senator Thad Cochran (R-MS) that would require the HHS to certify importation would pose, “no additional risk to the public health.” HHS secretaries of both political parties have said in the past that they cannot do this.
The bill would lift restrictions on important drugs, mostly from “Canadian” Internet pharmacies. The Thad Cochran amendment would allow for a certification process so that it doesn’t become a free-for-all of counterfeit drugs. The risk of purchasing counterfeit drugs at a pharmacy in Canada are relatively small, however the risks of receiving counterfeit drugs from an Internet pharmacy claiming to be in “Canada” are significant.
More on the topic in The Realities of Importation and Senate Backing Importation.
Dorgan’s issue is that drug prices are higher in the U.S. than in other parts of the world. He told the AP, “That’s my beef. Their pricing policies are wrong.” Dorgan seems to forget that it is U.S. policy that has created this situation – U.S. researchers (at drug companies, NIH and academic research institutions) subsidize the entire drug development process for the rest of the world.
On small positive, The Wall Street Journal is noting that before the bill can be formally voted on, the Senate must consider an amendment by Senator Thad Cochran (R-MS) that would require the HHS to certify importation would pose, “no additional risk to the public health.” HHS secretaries of both political parties have said in the past that they cannot do this.
The bill would lift restrictions on important drugs, mostly from “Canadian” Internet pharmacies. The Thad Cochran amendment would allow for a certification process so that it doesn’t become a free-for-all of counterfeit drugs. The risk of purchasing counterfeit drugs at a pharmacy in Canada are relatively small, however the risks of receiving counterfeit drugs from an Internet pharmacy claiming to be in “Canada” are significant.
More on the topic in The Realities of Importation and Senate Backing Importation.
Thursday, May 3, 2007
Health or Hubris? – NH Appeals Judge’s Data Decision
The State of New Hampshire has thumped its chest and announced it will appeal the Federal Judge’s decision to strike down the Prescription Information Law. Earlier this week, Judge Paul Barbadoro struck down the law for being Unconstitutional.
The state Attorney General Kelly Ayotte has said that the law protects physicians from pharmaceutical marketing and helps contain health care costs. In his 54-page ruling, Judge Barbadoro indicated that there were less invasive ways to manage health care costs, including many options not considered by the state. The Judge also noted that physicians already have the ability to shield themselves from pharmaceutical marketing through an American Medical Association (AMA) program or by not seeing reps.
Attorney General Ayotte said today, “The Prescription Information Law protects the State’s interests and the interests of New Hampshire’s physicians and citizens, which strongly outweigh the pharmaceutical industry’s interest in increased profits.” Evidently Attorney General Ayotte missed the trial because it wasn’t the pharmaceutical companies that the law targeted.
IMS Health issued a statement that reads: “We are confident the opinion will be upheld by the First Circuit. The Judge’s ruling in this matter is comprehensive, well reasoned and based solidly on existing law. Importantly, it upholds the country’s tradition of protecting free speech and the free flow of truthful information. We continue to believe that patients will benefit from a more transparent, safer and more competitive healthcare system as a result of the Judge’s decision. We are committed to evidence-based healthcare and believe that suppression of information will be harmful to our society as both citizens and patients.”
This looks more like posturing than a serious legal appeal. The Judge’s ruling seems solid and the State of New Hampshire has already agreed to all of the statements of fact several weeks ago (as noted by the AP). Can the citizen’s of New Hampshire afford another costly legal battle, having just lost one less than a week ago?
The state Attorney General Kelly Ayotte has said that the law protects physicians from pharmaceutical marketing and helps contain health care costs. In his 54-page ruling, Judge Barbadoro indicated that there were less invasive ways to manage health care costs, including many options not considered by the state. The Judge also noted that physicians already have the ability to shield themselves from pharmaceutical marketing through an American Medical Association (AMA) program or by not seeing reps.
Attorney General Ayotte said today, “The Prescription Information Law protects the State’s interests and the interests of New Hampshire’s physicians and citizens, which strongly outweigh the pharmaceutical industry’s interest in increased profits.” Evidently Attorney General Ayotte missed the trial because it wasn’t the pharmaceutical companies that the law targeted.
IMS Health issued a statement that reads: “We are confident the opinion will be upheld by the First Circuit. The Judge’s ruling in this matter is comprehensive, well reasoned and based solidly on existing law. Importantly, it upholds the country’s tradition of protecting free speech and the free flow of truthful information. We continue to believe that patients will benefit from a more transparent, safer and more competitive healthcare system as a result of the Judge’s decision. We are committed to evidence-based healthcare and believe that suppression of information will be harmful to our society as both citizens and patients.”
This looks more like posturing than a serious legal appeal. The Judge’s ruling seems solid and the State of New Hampshire has already agreed to all of the statements of fact several weeks ago (as noted by the AP). Can the citizen’s of New Hampshire afford another costly legal battle, having just lost one less than a week ago?
Photo from Pharmalot (again).
Thailand Says No to IP, Begs for Investment
Pharmalot is reporting that the military junta running Thailand will spend over $600,000 on a public relations image campaign to change its image. It seems they’ve realized that a military coup is not good for business investment.
Here’s a suggestion for Thailand—rather than spending over $600,000 on an image campaign, how about spending that money on directly helping the 500,000 Thais with HIV? I’m betting that $600,000 could buy an awful lot of condoms and prevention education.
As I mentioned in my BIO Annual Meeting Preview, I’m looking forward to the Sunday session at BIO titled “Thailand: Investment and Collaboration in Agricultural Development and Medical Innovation.” The description reads, “In support of biotech investment opportunities, Thailand provides excellent infrastructure, hands-on professionals, existing world-class research, government incentives and biodiversity.” I wonder if ‘government incentives’ is a euphemism for ‘violating your patents.’ One thing is for certain, Thailand will have a hard time luring biotech companies to the country by refusing to honor IP. However, I will enjoy watching the Thai envoy try to lure investment to the country.
Finally, a recent industry delegation is back from drug license negotiations in Thailand. Members reported that the Thai military junta sent armed observers to follow them. Were the military thugs there for protection or intimidation?
Looks like I won’t be going to Phuket in December after all.
Here’s a suggestion for Thailand—rather than spending over $600,000 on an image campaign, how about spending that money on directly helping the 500,000 Thais with HIV? I’m betting that $600,000 could buy an awful lot of condoms and prevention education.
As I mentioned in my BIO Annual Meeting Preview, I’m looking forward to the Sunday session at BIO titled “Thailand: Investment and Collaboration in Agricultural Development and Medical Innovation.” The description reads, “In support of biotech investment opportunities, Thailand provides excellent infrastructure, hands-on professionals, existing world-class research, government incentives and biodiversity.” I wonder if ‘government incentives’ is a euphemism for ‘violating your patents.’ One thing is for certain, Thailand will have a hard time luring biotech companies to the country by refusing to honor IP. However, I will enjoy watching the Thai envoy try to lure investment to the country.
Finally, a recent industry delegation is back from drug license negotiations in Thailand. Members reported that the Thai military junta sent armed observers to follow them. Were the military thugs there for protection or intimidation?
Looks like I won’t be going to Phuket in December after all.
Wednesday, May 2, 2007
FDA Proposes New Warnings For Adolescents and Antidepressants
I offer this straight from today's FDA press release with no commentary—
FDA Proposes New Warnings About Suicidal Thinking, Behavior in
Young Adults Who Take Antidepressant Medications
The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).
The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.
FDA has been developing language to revise product labeling and update the Patient Medication Guides for these products. Manufacturers of antidepressants will now have 30 days to submit their revised product labels and revised Medication Guides to FDA for review.
Products involved in today’s action include:
Anafranil (clomipramine)
Asendin (amoxapine)
Aventyl (nortriptyline)
Celexa (citalopram hydrobromide)
Cymbalta (duloxetine)
Desyrel (trazodone HCl)
Elavil (amitriptyline)
Effexor (venlafaxine HCl)
Emsam (selegiline)
Etrafon (perphenazine/amitriptyline)
fluvoxamine maleate
Lexapro (escitalopram hydrobromide)
Limbitrol (chlordiazepoxide/amitriptyline)
Ludiomil (maprotiline)
Marplan (isocarboxazid)
Nardil (phenelzine sulfate)
nefazodone HCl Norpramin (desipramine HCl)
Pamelor (nortriptyline)
Parnate (tranylcypromine sulfate)
Paxil (paroxetine HCl)
Physicians Fraud Government of $1.3 Billion
The AP has reported that physicians are collecting Medicare payments but are not paying taxes. In the first 9 months of 2005, 21,000 physicians engaged in the scheme, pocketing $1.3 billion in money that should have been paid in taxes.
To curb the abuse, Senators Norm Coleman (R-MN) and Carl Levin (D-MI) have introduced legislation this week to withhold Medicare payments to the physicians. The bill, S.1124, will require HHS and CMS to participate in the Federal Payment Levy Program. The bill would also allow for the recovery of unpaid child support from physician “dead beats.”
Whether CMS can manage the process effectively is another story.
To curb the abuse, Senators Norm Coleman (R-MN) and Carl Levin (D-MI) have introduced legislation this week to withhold Medicare payments to the physicians. The bill, S.1124, will require HHS and CMS to participate in the Federal Payment Levy Program. The bill would also allow for the recovery of unpaid child support from physician “dead beats.”
Whether CMS can manage the process effectively is another story.
Tuesday, May 1, 2007
New Hampshire Prescription Drug Abuse
After being challenged in my previous message on my assertions of prescription drug abuse in New Hampshire, I’d like to introduce some facts—
A recent report by an official government body, the Substance Abuse and Mental Health Services Administration (SAMHSA), found the following related to prescription drug abuse and misuse in New Hampshire:
A recent report by an official government body, the Substance Abuse and Mental Health Services Administration (SAMHSA), found the following related to prescription drug abuse and misuse in New Hampshire:
- Among young adults (18-25), misuse of psychotherapeutic drugs was 14.5% nationally and 19.3% in New Hampshire, putting it just behind West Virginia, but just ahead of Arkansas.
- Pain reliever misuse was 11.8% nationally among young adults (18-25) and was 15.8% in New Hampshire, again putting it just behind West Virginia, but just ahead of Indiana.
- Stimulant abuse among young adults (18-25) was 3.6% nationally and 5.7% in New Hampshire.
- Sedative abuse among young adults (18-25) was 0.5% nationally and 1.0% in New Hampshire (tying it with West Virginia).
A National Center for Health Statistics study from 1999-2004 on states with the highest increases in methadone-related fatalities put New Hampshire at number 6 (up there with Kentucky and Louisiana).
Finally, the Department of Justice wrote in a recent report on drug abuse wrote:
Diverted Pharmaceuticals. The diversion and abuse of several pharmaceutical drugs, particularly OxyContin (oxycodone) and Ritalin (methylphenidate), pose a significant and increasing threat to New Hampshire. Other pharmaceuticals such as Vicodin (hydrocodone) and Percocet (oxycodone) also are diverted and abused, although to a lesser extent. According to NHDSA data, the number of oxycodone-related treatment admissions to publicly funded facilities in New Hampshire increased substantially (204%) from 27 in 1997 to 82 in 2001. (See Table 1 on page 2.) The number of treatment admissions for Ritalin abuse in New Hampshire is not
available; however, state and local law enforcement officials report that
abuse levels are high among junior high and high school students.
These are prescription medications. So, in the majority of cases, a New Hampshire physician signed his or her name to a pad and enabled the abuse. In fact, the Department of Justice report notes that “doctor shopping” is one of the means by which these drugs are obtained for abusive purposes. It’s no wonder Rep. Rosenwald wanted this law – and all the more ironic that she chairs the New Hampshire House of Representatives Health, Human Services & Elderly Affairs Committee. Shouldn’t she have been trying to stop prescription drug abuse in New Hampshire, especially among children? So why pass a law to keep this information secret?
Representative Cindy Rosenwald’s actions were admirable – she wanted to protect her husband, Dr. Peter Klementowicz. Her motivations on behalf of her husband were openly discussed in an interview they gave with The New Republic magazine last year. It’s admirable that she wanted to protect her husband and help him shield his business practices, but it was a bad idea for the people of New Hampshire - a state suffering from prescription drug abuse.
Representative Cindy Rosenwald’s actions were admirable – she wanted to protect her husband, Dr. Peter Klementowicz. Her motivations on behalf of her husband were openly discussed in an interview they gave with The New Republic magazine last year. It’s admirable that she wanted to protect her husband and help him shield his business practices, but it was a bad idea for the people of New Hampshire - a state suffering from prescription drug abuse.May Medical Meetings
Here are the major medical meetings for May 2007—
April 28-May 5 – American Academy of Neurology 2007 Annual Meeting in Boston.
May 2-8 – American Society of Breast Surgeons 8th Annual Meeting in Phoenix.
May 5-9 – American Occupational Health Conference 2007 (AOHC) in New Orleans. Sponsored by American College of Occupational and Environmental Medicine (ACOEM).
May 9-11 – American Heart Association Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Conference 2007 in Washington, D.C. Pharm Aid will be covering this one.
May 24-27 – American Pediatric Surgical Association (APSA) 38th Annual Meeting in Orlando, Florida.
May 30-June 2 – American College of Sports Medicine 54th Annual Meeting in New Orleans.
April 28-May 5 – American Academy of Neurology 2007 Annual Meeting in Boston.
May 2-8 – American Society of Breast Surgeons 8th Annual Meeting in Phoenix.
May 5-9 – American Occupational Health Conference 2007 (AOHC) in New Orleans. Sponsored by American College of Occupational and Environmental Medicine (ACOEM).
May 9-11 – American Heart Association Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke Conference 2007 in Washington, D.C. Pharm Aid will be covering this one.
May 24-27 – American Pediatric Surgical Association (APSA) 38th Annual Meeting in Orlando, Florida.
May 30-June 2 – American College of Sports Medicine 54th Annual Meeting in New Orleans.
New Hampshire Data Ban Struck Down, Part II
After writing my previous posting New Hampshire Data Ban Struck Down, I received a very interesting e-mail this morning from a friend at pharmaceutical company with some very enlightening data attached.
As it turns out, New Hampshire has a major problem with prescription drug abuse. Doctors in NH prescribe nearly twice the national average of Schedule II narcotics. This is a very interesting wrinkle to the story. So was the law really about Medicaid costs (as the Representative Cindy Rosenwald contends) or was it about physician secrecy and prescribing behaviors, as I initially stated?
For New Hampshire to have double the national average of narcotic prescriptions, one of three things must be true:
As it turns out, New Hampshire has a major problem with prescription drug abuse. Doctors in NH prescribe nearly twice the national average of Schedule II narcotics. This is a very interesting wrinkle to the story. So was the law really about Medicaid costs (as the Representative Cindy Rosenwald contends) or was it about physician secrecy and prescribing behaviors, as I initially stated?
For New Hampshire to have double the national average of narcotic prescriptions, one of three things must be true:
1. The state has twice the national average of cancer patients and/or twice the national average of invasive surgery, so it would make sense they would have twice the level of narcotic usage.
2. The physicians in the State are not utilizing the best medical practices and are inappropriately over-using these powerful drugs. Therefore, they could benefit from education and counseling so as to not endanger patient’s health.
3. The physicians are running a side-business in narcotics (not unlike other recent high-profile cases on Long Island) and this law was an attempt to cut down on the number of people who know about it.
I hope it’s not the first. It could possibly be the second, but I’m afraid it’s probably the third. Is it this reason that motivated Representative Cindy Rosenwald to introduce this legislation for her husband the doctor?
I hope it’s not the first. It could possibly be the second, but I’m afraid it’s probably the third. Is it this reason that motivated Representative Cindy Rosenwald to introduce this legislation for her husband the doctor?
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