Latest Drugwonks' Blog
Another fine piece of straight-shooting journalism from the FT. The article, “Medical Marvals” (by Andrew Jack and Clive Cookson) looks at the challenges and opportunities of the FDA under Commissioner Peggy Hamburg.
It begins with a symbol:
“Margaret Hamburg had scarcely begun her work as commissioner of the US Food and Drug -Administration over the summer when she travelled to meet her counterparts at the European Medicines Agency in London. The trip symbolised a strengthening appetite for international cooperation between the FDA and the EMEA, at a time when the globalisation of medical products has highlighted continuing regulatory differences and made the demands for co-operation greater than ever before. It also reflected a fresh sense of self-confidence and willingness to communicate externally at the US agency, after several years of unstable leadership and internal demoralisation in the face of criticism from politicians, lawyers, companies and medical researchers alike.”
And ends with a reality check:
“Pitts argues the agency still faces enormous challenges in updating its computer systems and adapting to an era of biological medicines. As for international convergence, he adds it too has limits. Different nations need different bodies to be held accountable, he says.”
And, in between, much useful information and conversation.
The complete article can be found here:
http://www.ft.com/cms/s/0/b8e56a28-e32e-11de-b965-00144feab49a.html
And speaking of the FDA and Peggy Hamburg, the Hill reports that the FDA said "a proposal to enable the importation of cheaper prescription drugs could endanger the US medicine supply and would be difficult to implement." According to The Hill, "These criticisms from Margaret Hamburg, President Barack Obama's FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers' access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States." Sen. Byron Dorgan (D-ND) "introduced his amendment to the healthcare bill on Tuesday with the support of 19 other senators, including four Republicans, setting up a vote Wednesday."
And the Associated Press adds that Senator Dorgan replied to the FDA concerns, saying, "I'm going to go home kind of upset about this letter today from the FDA, which is in my judgment completely bogus." In its letter, the FDA "said that while Dorgan's plan seeks to address safety risks, concerns remain about copycat versions of high-technology biological drugs and about confusion surrounding the distribution of foreign products."
Senator, don’t go home mad. Just go home.
It begins with a symbol:
“Margaret Hamburg had scarcely begun her work as commissioner of the US Food and Drug -Administration over the summer when she travelled to meet her counterparts at the European Medicines Agency in London. The trip symbolised a strengthening appetite for international cooperation between the FDA and the EMEA, at a time when the globalisation of medical products has highlighted continuing regulatory differences and made the demands for co-operation greater than ever before. It also reflected a fresh sense of self-confidence and willingness to communicate externally at the US agency, after several years of unstable leadership and internal demoralisation in the face of criticism from politicians, lawyers, companies and medical researchers alike.”
And ends with a reality check:
“Pitts argues the agency still faces enormous challenges in updating its computer systems and adapting to an era of biological medicines. As for international convergence, he adds it too has limits. Different nations need different bodies to be held accountable, he says.”
And, in between, much useful information and conversation.
The complete article can be found here:
http://www.ft.com/cms/s/0/b8e56a28-e32e-11de-b965-00144feab49a.html
And speaking of the FDA and Peggy Hamburg, the Hill reports that the FDA said "a proposal to enable the importation of cheaper prescription drugs could endanger the US medicine supply and would be difficult to implement." According to The Hill, "These criticisms from Margaret Hamburg, President Barack Obama's FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers' access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States." Sen. Byron Dorgan (D-ND) "introduced his amendment to the healthcare bill on Tuesday with the support of 19 other senators, including four Republicans, setting up a vote Wednesday."
And the Associated Press adds that Senator Dorgan replied to the FDA concerns, saying, "I'm going to go home kind of upset about this letter today from the FDA, which is in my judgment completely bogus." In its letter, the FDA "said that while Dorgan's plan seeks to address safety risks, concerns remain about copycat versions of high-technology biological drugs and about confusion surrounding the distribution of foreign products."
Senator, don’t go home mad. Just go home.
My article in The Weekly Standard on the Mitch Daniels approach to health care reform:
http://theweeklystandard.com/Content/Public/Articles/000/000/017/277bjeer.asp?pg=2
http://theweeklystandard.com/Content/Public/Articles/000/000/017/277bjeer.asp?pg=2
Senator Bill Nelson (D, FL) is threatening to vote “nay” unless the Senate busts President Obama’s $80 billion Big Pharma “deal.” Senator Nelson wants deeper Medicare/Medicaid discounts and the complete annihilation of the infamous doughnut hole.
What do you call conflict of interest when it's the government writing the check? Healthcare reform legislation.
The Senate’s Patient Protection and Affordable Care Act would establish a new, independent, nonprofit, "Patient Centered Outcomes Research Institute" to contract with the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), and others to produce comparative effectiveness research (CER).
One section of the Senate bill imposes harsh penalties for the publication of certain types of research. While the bill allows for the publication of research conducted under contract to the Patient Centered Outcomes Research Institute in a peer-reviewed journal or other publications, the draft legislation also allow this new Institute, at its own discretion, to withhold funding from any institution whose researchers publish results that are not "within the bounds of and entirely consistent with the evidence."
"(iv) REQUIREMENTS FOR PUBLICATION OF RESEARCH- Any research published under clause (ii)(IV) shall be within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute under this subparagraph. If the Institute determines that those requirements are not met, the Institute shall not enter into another contract with the agency, instrumentality, or entity which managed or conducted such research for a period determined appropriate by the Institute (but not less than 5 years)."
Such language to restrict scientific freedom is unprecedented and likely unconstitutional.
Should we really be legislating science via threat of purse strings?
The Senate’s Patient Protection and Affordable Care Act would establish a new, independent, nonprofit, "Patient Centered Outcomes Research Institute" to contract with the Agency for Healthcare Research and Quality (AHRQ), the National Institutes of Health (NIH), and others to produce comparative effectiveness research (CER).
One section of the Senate bill imposes harsh penalties for the publication of certain types of research. While the bill allows for the publication of research conducted under contract to the Patient Centered Outcomes Research Institute in a peer-reviewed journal or other publications, the draft legislation also allow this new Institute, at its own discretion, to withhold funding from any institution whose researchers publish results that are not "within the bounds of and entirely consistent with the evidence."
"(iv) REQUIREMENTS FOR PUBLICATION OF RESEARCH- Any research published under clause (ii)(IV) shall be within the bounds of and entirely consistent with the evidence and findings produced under the contract with the Institute under this subparagraph. If the Institute determines that those requirements are not met, the Institute shall not enter into another contract with the agency, instrumentality, or entity which managed or conducted such research for a period determined appropriate by the Institute (but not less than 5 years)."
Such language to restrict scientific freedom is unprecedented and likely unconstitutional.
Should we really be legislating science via threat of purse strings?
Once more into the abyss.
Senator Byron Dorgan (D, ND) has proposed an amendment to the Senate’s healthcare reform bill that would allow drug importation from a gaggle of foreign nations.
It’s worth restating the facts.
State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. (And the brainchild of this scheme -- for those who may have forgotten -- was Wrong-Way Rod Blagojevich.)
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA.”
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
Shameful.
And speaking of Boston, Beantown’s offer of low-cost Canadian prescription drugs to city employees and retirees has, according to the Boston Globe, “ fizzled, never having attracted more than a few dozen participants.”
In late July of 2008, the Canadian supplier for the Boston program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
Surprising? Not really. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
Healthcare reform is already in deep enough fiscal trouble. Senator Dorgan shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that don’t save money and compromise safety make -- good soundbites notwithstanding.
Illusory savings aide, the real issue is safety.
All of the large Canadian internet pharmacies openly admit that the drugs they send to unsuspecting Americans are not “the same” drugs that Canadians get at their local pharmacy. They’re from other places — many from Europe. So what’s wrong with that? Two words — parallel trade — the term Europeans use for drug importation. Senator Dorgan may hide behind words like “from Canada” — but that’s not the reality because EU law makes it far more complicated and dangerous. According to the Treaty of Rome, parallel trade is completely legal and Articles 30 and 36 prohibit manufacturers from managing their European supply chains in their own or patients’ interests.
Sorry Senator, the truth is inconvenient.
Last year 140 million individual drug packages were parallel imported throughout the European Union — and a secondary wholesaler repackaged each and every one. (The same type of secondary wholesaler that we are trying to eliminate in the US because of their role as “weak link in the chain” — the chain of custody that is.)
This means that, literally, parallel traders in Europe 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 United States Senator) 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 British pharmacies. 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. Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
Stubborn facts.
The Dorgan Amendment? Just say no.
Senator Byron Dorgan (D, ND) has proposed an amendment to the Senate’s healthcare reform bill that would allow drug importation from a gaggle of foreign nations.
It’s worth restating the facts.
State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. (And the brainchild of this scheme -- for those who may have forgotten -- was Wrong-Way Rod Blagojevich.)
And what of Minnesota’s RxConnect? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.
And what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA.”
This is particularly appalling since the drugs being sent to U.S. customers from CanaRX are most certainly not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. CanaRX – by their own admission – sources their drugs from the European Union.
PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.
Shameful.
And speaking of Boston, Beantown’s offer of low-cost Canadian prescription drugs to city employees and retirees has, according to the Boston Globe, “ fizzled, never having attracted more than a few dozen participants.”
In late July of 2008, the Canadian supplier for the Boston program, Winnipeg-based Total Care Pharmacy, sent a letter to city officials saying the firm was terminating its agreement because there were so few participants. In 2006, Boston saved $4,300 on a total of 73 prescriptions. When Total Care decided to end its relationship with the city, only 16 Boston retirees were still participating.
Surprising? Not really. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.
Healthcare reform is already in deep enough fiscal trouble. Senator Dorgan shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that don’t save money and compromise safety make -- good soundbites notwithstanding.
Illusory savings aide, the real issue is safety.
All of the large Canadian internet pharmacies openly admit that the drugs they send to unsuspecting Americans are not “the same” drugs that Canadians get at their local pharmacy. They’re from other places — many from Europe. So what’s wrong with that? Two words — parallel trade — the term Europeans use for drug importation. Senator Dorgan may hide behind words like “from Canada” — but that’s not the reality because EU law makes it far more complicated and dangerous. According to the Treaty of Rome, parallel trade is completely legal and Articles 30 and 36 prohibit manufacturers from managing their European supply chains in their own or patients’ interests.
Sorry Senator, the truth is inconvenient.
Last year 140 million individual drug packages were parallel imported throughout the European Union — and a secondary wholesaler repackaged each and every one. (The same type of secondary wholesaler that we are trying to eliminate in the US because of their role as “weak link in the chain” — the chain of custody that is.)
This means that, literally, parallel traders in Europe 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 United States Senator) 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 British pharmacies. 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. Caveat Emptor is bad health care practice and even worse health care policy. Safety cannot be compromised, even if the truth is inconvenient.
Stubborn facts.
The Dorgan Amendment? Just say no.
Dana Milbank on the insipid, hollow, leaden "debate" over health care legislation in the Senate...
http://www.washingtonpost.com/wp-dyn/content/article/2009/12/01/AR2009120103158_2.html?wpisrc=nl_pmheadline
We need a fresh start, with fresh faces in the Senate...
http://www.youtube.com/watch?v=V8lT1o0sDwI
http://www.washingtonpost.com/wp-dyn/content/article/2009/12/01/AR2009120103158_2.html?wpisrc=nl_pmheadline
We need a fresh start, with fresh faces in the Senate...
http://www.youtube.com/watch?v=V8lT1o0sDwI
Another blog post claiming Merrill Goozner is an advocate of evidence-based medicine and an "expert"? For the record Merrill Goozner believes that Tysabri, the drug for MS was over-rated and that Avastin is a useless drug.. Goozner just hates private sector innovation... And again for the record the post below by Scott Hensley is just a repeat of a an article from Forbes.com..
www.npr.org/blogs/health/2009/11/mammogram_guideline_backlash_w.html
www.npr.org/blogs/health/2009/11/mammogram_guideline_backlash_w.html
Two-time winner of the Pulitzer Prize for Journalism and New York Times writer Nicholas Kristof recently repeated a claim that just won’t go away in a recent Op-Ed. It’s a figure cited with abandon by the likes of Congressman Alan Grayson and other single-payer zealots.
Kristof wrote the following in an Op-Ed in which he recounted the experience a man named John Brodniak had with the American health care system:
John’s story is not so unusual. A Harvard study, to be published next month in the American Journal of Public Health, suggests that almost 45,000 Americans die prematurely each year as a consequence of not having insurance. John may become one of them.
So which group is responsible for this 45,000 figure? That’s right, Physicians For A National Health Program – an organization with a long history of shoddy work in the area of health care “studies.” Unfortunately, their work is picked up by a lot of folks and media personalities whose knowledge of American Idol surpasses their understanding of health care policy.
John Goodman and Linda Gorman thoroughly discredited this sham study here.
Interestingly enough, Goodman and Gorman cite a report which shows that Medicaid patients have a higher mortality rate than the uninsured.
That’s because “coverage” for the sake of coverage doesn’t necessarily equate to access to quality health care. And being “uninsured” doesn’t mean one is going without access to health care.
Moreover, 28 percent of US doctors refuse to accept Medicaid patients. 19 percent will accept a limited amount of Medicaid patients. This is mostly due to the low reimbursement levels of Medicaid. It also bears mentioning that Massachusetts has one of the lowest uninsured rates of all the states. But that statistic is more reflective of the expansion of subsidies, Medicaid enrollment, and the individual insurance mandate. It is not reflective of sound health care policy. Massachusetts has more physicians than any other state but is encountering a growing physician shortage and substantial waiting times to see a doctor or specialist.
Why is this all relevant? Well, the legislation in both the House and Senate would dramatically expand Medicaid, forcing millions more Americans into the government health care system.
As for the rest of the content of Nicholas Kristof’s piece, John Graham has an excellent response here. Michelle Malkin also tears into Kristof’s Op-Ed here.
Economist Thomas Sowell on the purported savings of health care reform:
“Here is a math problem for you: Assume that the legislation establishing government control of medical care is passed and that it 'brings down the cost of medical care.' You pay $500 a year less for your medical care, but the new costs put on employers is passed on to consumers, so that you pay $300 a year more for groceries and $200 a year more for gasoline, while the new mandates put on insurance companies raise your premiums by $300 a year, how much money have you saved?”
CDER now has two deputy directors. And two heads are better than one – especially when they belong to Doug Throckmorton and Bob Temple.
Bob Temple has been named deputy director for clinical science with primary responsibility for high-level initiatives and programs related to clinical science and clinical trial methodology issues. He retains his position as acting director for the office of drug evaluation I.
Current CDER deputy director Dr Douglas Throckmorton becomes deputy director for regulatory programs and will continue as the primary representative on high-level initiatives and programs related to the regulation of drugs that are controlled substances and CDER programs on bioterrorism, emergency response and coordination.
Dr Rachel Behrman has been named acting associate center director for medical policy and acting director of the office of medical policy. She will lead medical policy programs and strategic initiatives involving drug promotion and advertising, clinical trial design, human subject protection and good clinical practices.
A good use of great talent.
Bob Temple has been named deputy director for clinical science with primary responsibility for high-level initiatives and programs related to clinical science and clinical trial methodology issues. He retains his position as acting director for the office of drug evaluation I.
Current CDER deputy director Dr Douglas Throckmorton becomes deputy director for regulatory programs and will continue as the primary representative on high-level initiatives and programs related to the regulation of drugs that are controlled substances and CDER programs on bioterrorism, emergency response and coordination.
Dr Rachel Behrman has been named acting associate center director for medical policy and acting director of the office of medical policy. She will lead medical policy programs and strategic initiatives involving drug promotion and advertising, clinical trial design, human subject protection and good clinical practices.
A good use of great talent.
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.
