Latest Drugwonks' Blog
During the election, candidate Obama called candidate McCain’s proposal to tax employer-provided health benefits “the largest middle-class tax increase in history.” Today President Obama is sending signals that he would support the same idea.
Representative Pete Stark (D, CA) says it's a "stupid idea."
According to the New York Times, such a tax could raise $3.6 trillion over a decade to help “expand coverage to the 46 million uninsured Americans.”
(The complete New York Times article – worth a read – can be found here.)
Except when you take an honest look at who is being inappropriately included in that 46 million (4.1 million now eligible for government benefits via expanded SCHIP + 12 million already eligible for government programs but not signed up + 10 million illegal aliens, + 10 million Americans “opting out” = 32 million) it really comes out to about 14 million uninsured Americans.
$3.6 billion (over 10 years) + the President’s proposed $634 billion “down payment” (over 10 years) divided by 14 million uninsured. Talk about healthcare inflation!
(And this isn't counting the dollars allocated via the stimulus package that provides unemployment insurance-eligible Americans and their families with government health insurance as part of their benefits.)
For more on miscounting the uninsured, see “Sasquatch Care.”
Another thing the candidate Obama was against but now supports seems to be drug importation. Can support of government price controls be far behind?
Representative Pete Stark (D, CA) says it's a "stupid idea."
According to the New York Times, such a tax could raise $3.6 trillion over a decade to help “expand coverage to the 46 million uninsured Americans.”
(The complete New York Times article – worth a read – can be found here.)
Except when you take an honest look at who is being inappropriately included in that 46 million (4.1 million now eligible for government benefits via expanded SCHIP + 12 million already eligible for government programs but not signed up + 10 million illegal aliens, + 10 million Americans “opting out” = 32 million) it really comes out to about 14 million uninsured Americans.
$3.6 billion (over 10 years) + the President’s proposed $634 billion “down payment” (over 10 years) divided by 14 million uninsured. Talk about healthcare inflation!
(And this isn't counting the dollars allocated via the stimulus package that provides unemployment insurance-eligible Americans and their families with government health insurance as part of their benefits.)
For more on miscounting the uninsured, see “Sasquatch Care.”
Another thing the candidate Obama was against but now supports seems to be drug importation. Can support of government price controls be far behind?
According to Douglas Schoen (formerly a pollster for President Bill Clinton) and Scott Rasmussen (president of Rasmussen Reports, an independent national polling company), “It is simply wrong for commentators to continue to focus on President Barack Obama's high levels of popularity, and to conclude that these are indicative of high levels of public confidence in the work of his administration”
Relative to healthcare reform, they find that a majority of Americans aren’t so keen after all to have their Uncle Sam become Uncle Sam, MD:
“There is no real appetite for increasing taxes to pay for an expanded health-insurance program. Less than half would support such an idea, which is 17% less than the percentage that supported government health insurance when Bill Clinton first considered it in March of 1993.”
(Their complete opinion piece in today’s edition of the Wall Street Journal can be found here.)
The conclusions reached by Schoen and Rasmussen are completely in line with a poll fielded by the Center for Medicine in the Public Interest last October.
The CMPI survey was of “Millennial” voters (18-28 years old) -- often portrayed as the new “driving force” in American politics. When millennial voters were engaged on the issue of health care reform they had some very strong – and often contradictory – opinions a -- particularly when it comes to issue of “universal care.”
The national public opinion poll of young voters (the result of 1001completed interviews with adults 18-28 years of age who are registered to vote) shows limited acceptance for the potential consequences of greater government control over health care.
While millennial voters report to strongly support the need for reform and the concept of “universal care,” when asked if they are willing to pay higher taxes to pay for a government-run health care system, their level of support swiftly turns in the opposite direction.
Millennial voters are strongly against government-care that results in longer wait times to see a health care provider, limits to the types of treatments and medicines they can access, and the potential for the government to interfere in the decision making and relationship between doctor and patient.
Some germane findings:
* A majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden;
* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,
* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.
(For further details on the CMPI poll, see “The Young and the Restless.”)
The CMPI poll and the findings of Schoen and Rasmussen demonstrate that all sides of the debate need to do a better job educating Americans about how various reform plans will impact the future of our healthcare system.
Nobody said it was going to be easy.
Relative to healthcare reform, they find that a majority of Americans aren’t so keen after all to have their Uncle Sam become Uncle Sam, MD:
“There is no real appetite for increasing taxes to pay for an expanded health-insurance program. Less than half would support such an idea, which is 17% less than the percentage that supported government health insurance when Bill Clinton first considered it in March of 1993.”
(Their complete opinion piece in today’s edition of the Wall Street Journal can be found here.)
The conclusions reached by Schoen and Rasmussen are completely in line with a poll fielded by the Center for Medicine in the Public Interest last October.
The CMPI survey was of “Millennial” voters (18-28 years old) -- often portrayed as the new “driving force” in American politics. When millennial voters were engaged on the issue of health care reform they had some very strong – and often contradictory – opinions a -- particularly when it comes to issue of “universal care.”
The national public opinion poll of young voters (the result of 1001completed interviews with adults 18-28 years of age who are registered to vote) shows limited acceptance for the potential consequences of greater government control over health care.
While millennial voters report to strongly support the need for reform and the concept of “universal care,” when asked if they are willing to pay higher taxes to pay for a government-run health care system, their level of support swiftly turns in the opposite direction.
Millennial voters are strongly against government-care that results in longer wait times to see a health care provider, limits to the types of treatments and medicines they can access, and the potential for the government to interfere in the decision making and relationship between doctor and patient.
Some germane findings:
* A majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden;
* Sixty-two percent said they would not support any health care reforms that could increase wait-times to see a doctor or the availability of treatments and medicines; and,
* Millennial voters were also equally unsupportive (62 percent) of health care reforms that would increase the role of the government regulation and oversight in doctor-patient decision-making.
(For further details on the CMPI poll, see “The Young and the Restless.”)
The CMPI poll and the findings of Schoen and Rasmussen demonstrate that all sides of the debate need to do a better job educating Americans about how various reform plans will impact the future of our healthcare system.
Nobody said it was going to be easy.
Meghan, Clyne, a former speechwriter for President George W. Bush, has an edifying piece in the New York Post about President Obama’s announcement that the federal government will be funding embryonic stem cell research. Of particular interest, though, are the connections high-ranking Obama Administration science officials have with groups that stand to benefit handsomely from the new policy.
It is interesting how in cases such as this silence suddenly overtakes the usual troublemakers who incessantly whine about research funded by the pharmaceutical industry being tainted.
This week CMPI president Peter Pitts also touched upon this gross double-standard in his Op-Ed in The Journal of Life Sciences. Read that article here.
Here are the relevant excerpts from Meghan Clyne’s piece:
Problem is, the administration's preening about its own scientific purity just isn't justified.
Consider, for instance, Eric Lander and Harold Varmus - the co-chairmen of the President's Council of Advisers on Science and Technology, which helps steer decisions on issues like the stem-cell matter.
Lander is a renowned stem-cell researcher at MIT, a world-class university that stands to get even more federal funding, thanks to Obama's stem-cell move. An MIT spokeswoman says the university takes conflict-of-interest precautions when its faculty serve in government positions - but added that it won't recuse itself from funding opportunities related to Obama's decision.
More of the public-relations legwork on the Obama stem-cell decision has been done by the advisory council's oth- er co-chairman, Harold Varmus.
What of Varmus? The president lauded him Monday as an example of the type of "outstanding scientists" who "will guide us in the years to come." He's a Nobel-prize winning scientist who now serves as president of the Memorial Sloan Kettering Cancer 20Center.
And a spokeswoman says Sloane Kettering's Stem-Cell Research Facility didn't qualify for federal funds under the Bush policy, because it uses tissues that violate the Bush ethical guidelines. Now that Obama has reversed that policy, the federal funding floodgates are open.
According to its most recent IRS 990 form, the hospital is already pretty good at working the public-sector pump: For 2007, it reported $120 million in revenue from government grants. Documents show that in 2006, Varmus earned more than $250,000 worth of his salary for "fund-raising."
Read full Op-Ed here:
CMPI recently visited the Conservative Political Action Conference in Washington, DC and had the opportunity to speak with Governor Tim Pawlenty of Minnesota. As some might recall, Governor Pawlenty was one of the leading contenders for Senator McCain’s VP running-mate.
Governor Pawlenty has been one of the more active governors in the country in advancing free market based healthcare initiatives.
He has been an ardent proponent of electronic health records and co-authored the following Op-Ed last year with Former Speaker of the House Newt Gingrich:
Read Op-Ed here.
Read Op-Ed here.
We asked Governor Pawlenty if he had any advice to offer President Obama as his administration tackles healthcare reform. Governor Pawlenty said, “I’m afraid that President Obama and the Congress are headed in a very different direction” from free-market healthcare reforms.
He noted, “I think we should get consumers involved” and “let them decide in the marketplace how to best manage their healthcare.”
Let’s hope Administration officials are listening.
SUTENT SIGNIFICANTLY INCREASES PROGRESSION FREE SURVIVAL FOR PATIENTS WITH ADVANCED PANCREATIC ISLET CELL TUMORS,
STUDY STOPPED EARLY
NEW YORK, NY, March 12 -- Pfizer Inc announced today that a phase 3 clinical trial of Sutent (sunitinib malate) has been stopped early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors.
An independent Data Monitoring Committee (DMC) recommended halting the trial after concluding that Sutent demonstrated greater progression-free survival compared to placebo plus best supportive care in patients with pancreatic islet cell tumors.
“We are delighted by these findings which demonstrate that Sutent provides a benefit for patients with advanced, well-differentiated pancreatic islet cell tumors — a rare cancer with limited treatment options,” said Dr. Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer’s Oncology Business Unit. “These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors.”
Pfizer has notified clinical trial investigators involved in the trial and regulatory agencies of the DMC recommendations. All patients in the trial will have the option to continue taking Sutent or be switched from placebo to Sutent. The full data set from this trial is being analyzed and more details will be presented at an upcoming scientific meeting.
This phase III trial of sunitinib in patients with advanced pancreatic islet cell tumors was initiated based on the results of a earlier phase II trial published in the Journal of Clinical Oncology(July 2008).
In contrast to exocrine pancreatic adenocarcinoma, pancreatic islet cell tumors are rare, indolent tumors of the endocrine pancreas with an incidence of 5-10 per million worldwide annually. Pancreatic islet cell tumors include insulinomas, glucagonomas and gastrinomas. Current treatment options are limited.
Sutent is currently approved for both advanced renal cell carcinoma (RCC) and second-line gastrointestinal stromal tumor (GIST), based on efficacy and safety data from large, randomized Phase 3 clinical trials. Sutent has played an important role in reshaping the treatment landscape for these two difficult-to-treat cancers. To date, more than 38,000 patients globally have been treated with Sutent in the clinical setting and trials.
This is the second phase III Sutent trial Pfizer has stopped early on the recommendation of an independent data monitoring committee due to benefit. In January 2005, a phase III trial in GIST was unblinded early when a planned interim analysis showed significantly longer time to tumor progression with Sutent compared to placebo.
STUDY STOPPED EARLY
NEW YORK, NY, March 12 -- Pfizer Inc announced today that a phase 3 clinical trial of Sutent (sunitinib malate) has been stopped early after the drug showed significant benefit in patients with advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine tumors.
An independent Data Monitoring Committee (DMC) recommended halting the trial after concluding that Sutent demonstrated greater progression-free survival compared to placebo plus best supportive care in patients with pancreatic islet cell tumors.
“We are delighted by these findings which demonstrate that Sutent provides a benefit for patients with advanced, well-differentiated pancreatic islet cell tumors — a rare cancer with limited treatment options,” said Dr. Mace Rothenberg, senior vice president of medical development and clinical affairs for Pfizer’s Oncology Business Unit. “These and previously reported phase 2 data contribute to the growing body of evidence indicating activity with sunitinib in patients with pancreatic islet cell tumors.”
Pfizer has notified clinical trial investigators involved in the trial and regulatory agencies of the DMC recommendations. All patients in the trial will have the option to continue taking Sutent or be switched from placebo to Sutent. The full data set from this trial is being analyzed and more details will be presented at an upcoming scientific meeting.
This phase III trial of sunitinib in patients with advanced pancreatic islet cell tumors was initiated based on the results of a earlier phase II trial published in the Journal of Clinical Oncology(July 2008).
In contrast to exocrine pancreatic adenocarcinoma, pancreatic islet cell tumors are rare, indolent tumors of the endocrine pancreas with an incidence of 5-10 per million worldwide annually. Pancreatic islet cell tumors include insulinomas, glucagonomas and gastrinomas. Current treatment options are limited.
Sutent is currently approved for both advanced renal cell carcinoma (RCC) and second-line gastrointestinal stromal tumor (GIST), based on efficacy and safety data from large, randomized Phase 3 clinical trials. Sutent has played an important role in reshaping the treatment landscape for these two difficult-to-treat cancers. To date, more than 38,000 patients globally have been treated with Sutent in the clinical setting and trials.
This is the second phase III Sutent trial Pfizer has stopped early on the recommendation of an independent data monitoring committee due to benefit. In January 2005, a phase III trial in GIST was unblinded early when a planned interim analysis showed significantly longer time to tumor progression with Sutent compared to placebo.
Commissioner Hamburg and Deputy Commissioner Sharfstein. Does this mean a partnership where one addresses the FDA’s food-side mission (Hamburg) and the other drugs and devices (Sharfstein)? Does it mean that the FDA will be under the thumb of Representative Henry Waxman? (Dr. Sharfstein was a former Waxman staffer.) Or does it mean that the FDA now has the political cover to remove the knife from its back and get back to work?
Will Dr. Sharfstein’s strong support of more robust OTC labeling help or hinder the FDA’s move towards a BTC (Behind-the-Counter) regulatory paradigm?
How will Dr. Hamburg address the dire state of food safety and security at an agency that gets dinged by our elected representatives – but for which Congress is slow to write a bigger check? Will Dr. Hamburg fight for an FDA food safety and security stimulus package? She certainly has the bona fides to do so.
And what about DTC? Will we see more letters (a perennial Hanukah wish from Mr. Waxman) or a move towards brighter lines from DDMAC?
And then there’s the question of REMS plans and complete response letters.
And biomarkers.
And guidance on off-label promotion.
And follow-on biologics.
And bioequivalence for generics.
And drug importation.
And comparative effectiveness for NDA submissions.
And companion diagnostics.
And 510(k) reform.
And greater international harmonization.
And the working relationship with the senior career staff at FDA.
And working relationships with industry and academia.
And, and, and …
Many questions. Few answers.
Here are seven things for Dr. Hamburg and Dr. Sharfstein to consider:
1. A Strong, Science-Based FDA
Everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible. Every specific action the agency takes is an opportunity to speak to a larger public health issue. Vioxx, for example, was a missed occasion for the FDA to seize the day on the issue of drug safety. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. This is not a people-intensive proposition. But it does require the commitment and the skill to do it – and do it right and regularly.
2. The Reagan/Udall Foundation: A Partnership of Unequals
The FDA must be both regulator in protecting the public health and colleague in helping to advance it. This is a delicate balance and in the current political climate the agency gets no merit points for being seen as collaborating with those it regulates. The best way to do this is via the Reagan/Udall Foundation. Now that the election is over an immediate first step should be for the new FDA Commissioner to meet with Representative DeLauro and issue a joint announcement on moving forward with the work of the agency’s Critical Path program to develop the tools necessary for 21st Century pharmaceutical and medical device development and regulation. But FDA must be seen as leading rather than simply participating in the process.
3. Clarity vs. Ambiguity
Regulators often love ambiguity – because ambiguity is power. The problem is that such a philosophy can lead to regulatory dissonance – ranging from completed Phase III trials supported by the agency at advisory committee meetings and then derided by a division afterwards, to warning letters sent to companies over marketing materials that have been “pre-cleared” by DDMAC. If people want the various industries regulated by the FDA to follow the rules, there need to be as many bright lines as possible – and they need to apply to everyone equally. While a high degree of pragmatism will always be required, this is not an excuse for “I know it when I see it” regulation.
4. Information Management
The FDA’s information management system is dysfunctional. The FDA sits at the crossroads of vast amounts of information that is of vital use to both protecting and advancing the public health. –yet most of it is unusable. The new Commissioner should immediately appoint an IT Czar who, as her first order of business, should audit existing systems and draw up an information technology roadmap for the agency. A solid “taskforce of talent” is needed to address this tremendous opportunity. Solid information management systems will allow the agency to do its job better, faster, and less expensively. A solid public health triple play.
5. Food Safety and Security
The agency’s programs on food safety and security are failing. Resources at CFSAN (the Center for Food Safety and Applied Nutrition) are stretched drum tight. More money is certainly needed – but there is also a crisis in confidence that the agency knows what it’s doing – or that it cares. The issue of BPA (bisphenol A) is a good example. The FDA was purely reactive in its call for a review by its panel of experts. As a result, the agency was destined to have its judgment called into question whatever the decision. And this is precisely what happened. This further cements the general perception that the FDA doesn’t care and/or is beholden to the industries it regulates. The BPA issue was out there for a long time in a visible way. And the agency didn’t do anything. It didn’t lead, it followed. And the consequences shouldn’t have surprised anyone. A similar situation is brewing with melamine in baby formula. Further, there is a growing sense that CFSAN should be moved to its own independent status within HHS. Perhaps. But for this to proceed, serious thinking needs to go into two issues: (1) DSHEA and the regulation of dietary supplements as foods, and (2) the increasingly important issue of nutriceuticals and qualified health claims. Both are clearly FDA issues and should remain so.
6. Risk Communications
Rather than assuming the mantle of responsibility and proactively stepping forward with more regular and transparent risk communications programs, the FDA was driven by the winds of crisis. Today the agency has implemented certain programs (some required by FDAAA) that provide risk information – but without any context, rhyme or reason. The result is confusion among patients and physicians and a field day for the media. The unintended consequences have swamped the public health benefit. Senior agency leadership knows it – but what are they doing to address it? The answer is not clear. A good beginning would be for the FDA’s Risk Communications Advisory to look into the matter. This problem needs to be fixed as no one (not industry, not doctors, not patients,) is happy with the current state of affairs.
7. The Drug Label and the “Safe Use” of Drugs
Wyeth v. Levine notwithstanding, the drug label is the single most important piece of communications material the agency issues – and it isn’t working as well as it should. The New Physician Labeling Rule (January 2006) has had minimal impact for three main reasons: (1) It has not been widely adopted for products licensed prior to the rule (not a requirement, but an option), (2) There has been little agency out-reach to physicians and, (3) There has been no broader agency program on the issue of “safe use.” This last point will change in January when the FDA (via CDER – the Center for Drug Evaluation and Research) launches a more comprehensive “safe use” initiative. The agency must consider not just safety, efficacy and quality – but safe use as well. Not just drug safety, but patient safety. This makes perfect sense and gives the FDA the opportunity to speak not only to physicians, but to consumers as well. The program should be expanded to also include medical devices. It is a timely, important, and urgent opportunity and must be done with determination, creativity, and relentless passion. It must be the FDA on the offense for the public health. And the offense must never stop.
Good luck Peggy. Good luck Josh.
Let’s get to work.
Will Dr. Sharfstein’s strong support of more robust OTC labeling help or hinder the FDA’s move towards a BTC (Behind-the-Counter) regulatory paradigm?
How will Dr. Hamburg address the dire state of food safety and security at an agency that gets dinged by our elected representatives – but for which Congress is slow to write a bigger check? Will Dr. Hamburg fight for an FDA food safety and security stimulus package? She certainly has the bona fides to do so.
And what about DTC? Will we see more letters (a perennial Hanukah wish from Mr. Waxman) or a move towards brighter lines from DDMAC?
And then there’s the question of REMS plans and complete response letters.
And biomarkers.
And guidance on off-label promotion.
And follow-on biologics.
And bioequivalence for generics.
And drug importation.
And comparative effectiveness for NDA submissions.
And companion diagnostics.
And 510(k) reform.
And greater international harmonization.
And the working relationship with the senior career staff at FDA.
And working relationships with industry and academia.
And, and, and …
Many questions. Few answers.
Here are seven things for Dr. Hamburg and Dr. Sharfstein to consider:
1. A Strong, Science-Based FDA
Everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible. Every specific action the agency takes is an opportunity to speak to a larger public health issue. Vioxx, for example, was a missed occasion for the FDA to seize the day on the issue of drug safety. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. This is not a people-intensive proposition. But it does require the commitment and the skill to do it – and do it right and regularly.
2. The Reagan/Udall Foundation: A Partnership of Unequals
The FDA must be both regulator in protecting the public health and colleague in helping to advance it. This is a delicate balance and in the current political climate the agency gets no merit points for being seen as collaborating with those it regulates. The best way to do this is via the Reagan/Udall Foundation. Now that the election is over an immediate first step should be for the new FDA Commissioner to meet with Representative DeLauro and issue a joint announcement on moving forward with the work of the agency’s Critical Path program to develop the tools necessary for 21st Century pharmaceutical and medical device development and regulation. But FDA must be seen as leading rather than simply participating in the process.
3. Clarity vs. Ambiguity
Regulators often love ambiguity – because ambiguity is power. The problem is that such a philosophy can lead to regulatory dissonance – ranging from completed Phase III trials supported by the agency at advisory committee meetings and then derided by a division afterwards, to warning letters sent to companies over marketing materials that have been “pre-cleared” by DDMAC. If people want the various industries regulated by the FDA to follow the rules, there need to be as many bright lines as possible – and they need to apply to everyone equally. While a high degree of pragmatism will always be required, this is not an excuse for “I know it when I see it” regulation.
4. Information Management
The FDA’s information management system is dysfunctional. The FDA sits at the crossroads of vast amounts of information that is of vital use to both protecting and advancing the public health. –yet most of it is unusable. The new Commissioner should immediately appoint an IT Czar who, as her first order of business, should audit existing systems and draw up an information technology roadmap for the agency. A solid “taskforce of talent” is needed to address this tremendous opportunity. Solid information management systems will allow the agency to do its job better, faster, and less expensively. A solid public health triple play.
5. Food Safety and Security
The agency’s programs on food safety and security are failing. Resources at CFSAN (the Center for Food Safety and Applied Nutrition) are stretched drum tight. More money is certainly needed – but there is also a crisis in confidence that the agency knows what it’s doing – or that it cares. The issue of BPA (bisphenol A) is a good example. The FDA was purely reactive in its call for a review by its panel of experts. As a result, the agency was destined to have its judgment called into question whatever the decision. And this is precisely what happened. This further cements the general perception that the FDA doesn’t care and/or is beholden to the industries it regulates. The BPA issue was out there for a long time in a visible way. And the agency didn’t do anything. It didn’t lead, it followed. And the consequences shouldn’t have surprised anyone. A similar situation is brewing with melamine in baby formula. Further, there is a growing sense that CFSAN should be moved to its own independent status within HHS. Perhaps. But for this to proceed, serious thinking needs to go into two issues: (1) DSHEA and the regulation of dietary supplements as foods, and (2) the increasingly important issue of nutriceuticals and qualified health claims. Both are clearly FDA issues and should remain so.
6. Risk Communications
Rather than assuming the mantle of responsibility and proactively stepping forward with more regular and transparent risk communications programs, the FDA was driven by the winds of crisis. Today the agency has implemented certain programs (some required by FDAAA) that provide risk information – but without any context, rhyme or reason. The result is confusion among patients and physicians and a field day for the media. The unintended consequences have swamped the public health benefit. Senior agency leadership knows it – but what are they doing to address it? The answer is not clear. A good beginning would be for the FDA’s Risk Communications Advisory to look into the matter. This problem needs to be fixed as no one (not industry, not doctors, not patients,) is happy with the current state of affairs.
7. The Drug Label and the “Safe Use” of Drugs
Wyeth v. Levine notwithstanding, the drug label is the single most important piece of communications material the agency issues – and it isn’t working as well as it should. The New Physician Labeling Rule (January 2006) has had minimal impact for three main reasons: (1) It has not been widely adopted for products licensed prior to the rule (not a requirement, but an option), (2) There has been little agency out-reach to physicians and, (3) There has been no broader agency program on the issue of “safe use.” This last point will change in January when the FDA (via CDER – the Center for Drug Evaluation and Research) launches a more comprehensive “safe use” initiative. The agency must consider not just safety, efficacy and quality – but safe use as well. Not just drug safety, but patient safety. This makes perfect sense and gives the FDA the opportunity to speak not only to physicians, but to consumers as well. The program should be expanded to also include medical devices. It is a timely, important, and urgent opportunity and must be done with determination, creativity, and relentless passion. It must be the FDA on the offense for the public health. And the offense must never stop.
Good luck Peggy. Good luck Josh.
Let’s get to work.
Media accounts note FDA Commissioner-in-Waiting Peggy Hamburg's stint as NYC Public Health commissioner.
But to me her best credential was her long scientific association with Dr. Joshua Lederberg.
Dr. Lederberg cared about the FDA, the Critical Path, the swamping of 21st century science by junk science, fear mongering, the dumbing down of drug companies and reimbursement systems that discouraged innovation.
Great minds don't think alike. They are independent. But they also can withstand the political bluster in support of science and medical progress.
Josh Lederberg did this and more.
Let's hope Peggy Hamburg, whose scientific and public health credentials are excellent, does the same. Let's hope she supports the Janet Woodcocks, Bob Temples, Larry Lesko's and others who want to lead the FDA into a future of personalized and prospective medicine and food safety and not the fearmongers from in and outside the agency that want to bring it down because the hate the commercialization of medical knowledge.
But to me her best credential was her long scientific association with Dr. Joshua Lederberg.
Dr. Lederberg cared about the FDA, the Critical Path, the swamping of 21st century science by junk science, fear mongering, the dumbing down of drug companies and reimbursement systems that discouraged innovation.
Great minds don't think alike. They are independent. But they also can withstand the political bluster in support of science and medical progress.
Josh Lederberg did this and more.
Let's hope Peggy Hamburg, whose scientific and public health credentials are excellent, does the same. Let's hope she supports the Janet Woodcocks, Bob Temples, Larry Lesko's and others who want to lead the FDA into a future of personalized and prospective medicine and food safety and not the fearmongers from in and outside the agency that want to bring it down because the hate the commercialization of medical knowledge.
Is comparative effectiveness entering a new "show me" state?
Bloomberg reports that,
"For two years, Pfizer, Inc. was quietly giving free doses of its expensive cancer drug Sutent as part of a campaign to help persuade the U.K. to pay for it. Last month, Pfizer finally won. The agency that advises the U.K.’s National Health Service decided the medicine extended the lives of patients enough to justify its cost, as long as the first course of treatment was free. The campaign wasn’t publicized by Pfizer or the U.K. and was revealed in interviews with government and company officials. The campaign cost Pfizer about 2.5 million pounds ($3.5 million) and gained the world’s biggest drugmaker an advantage over competing products made by Roche Holding AG, Bayer AG and Wyeth."
“It’s a relatively new phenomenon, and I think we’ll see more of it,” said Chris Brinsmead, president of the Association of British Pharmaceutical Industry.
The creative pricing arrangements lower the overall expense for the National Health Service and improve the ratio of cost to benefit that the National Institute for Health and Clinical Excellence uses to determine if a medicine should be covered. In all, drugs cost the nation 11 billion pounds annually, about 10 percent of the total health-care bill.
Johnson & Johnson’s blood-cancer drug Velcade won coverage in 2007 after the New Brunswick, New Jersey-based company said it would pay back the government for people who didn’t benefit. Patients get the first four doses of the 762.38 pound drug, then are tested to see if they’ve responded to the treatment. Those who improved continue with the drug. Johnson & Johnson provides a rebate of about 3,000 pounds for those who didn’t respond.
According to Sir Michael Rawlins, Chairman of NICE, “We’re meeting them partway.”
The complete Bloomberg story can be found here.
It's a creative approach based on outcomes -- a giant step towards recognizing the importance of personalized medicine the folly of basing reimbursement decisions on large-scale general population studies.
Bloomberg reports that,
"For two years, Pfizer, Inc. was quietly giving free doses of its expensive cancer drug Sutent as part of a campaign to help persuade the U.K. to pay for it. Last month, Pfizer finally won. The agency that advises the U.K.’s National Health Service decided the medicine extended the lives of patients enough to justify its cost, as long as the first course of treatment was free. The campaign wasn’t publicized by Pfizer or the U.K. and was revealed in interviews with government and company officials. The campaign cost Pfizer about 2.5 million pounds ($3.5 million) and gained the world’s biggest drugmaker an advantage over competing products made by Roche Holding AG, Bayer AG and Wyeth."
“It’s a relatively new phenomenon, and I think we’ll see more of it,” said Chris Brinsmead, president of the Association of British Pharmaceutical Industry.
The creative pricing arrangements lower the overall expense for the National Health Service and improve the ratio of cost to benefit that the National Institute for Health and Clinical Excellence uses to determine if a medicine should be covered. In all, drugs cost the nation 11 billion pounds annually, about 10 percent of the total health-care bill.
Johnson & Johnson’s blood-cancer drug Velcade won coverage in 2007 after the New Brunswick, New Jersey-based company said it would pay back the government for people who didn’t benefit. Patients get the first four doses of the 762.38 pound drug, then are tested to see if they’ve responded to the treatment. Those who improved continue with the drug. Johnson & Johnson provides a rebate of about 3,000 pounds for those who didn’t respond.
According to Sir Michael Rawlins, Chairman of NICE, “We’re meeting them partway.”
The complete Bloomberg story can be found here.
It's a creative approach based on outcomes -- a giant step towards recognizing the importance of personalized medicine the folly of basing reimbursement decisions on large-scale general population studies.
No doubt this story will be all over the mainstream media tomorrow as another example of “tainted” industry-sponsored research.
Now this is a terrible case of ethics abuse – but trying to pin the rap on industry (in this case, Pfizer, Merck, and Wyeth) is quite a stretch.
But that won't stop politicians from trying. After all, nothing like a little Pharma-bashing to get the electorate all hot and bothered. Case in point, Connecticut Attorney General Richard Blumenthal who commented that, “When the public and professionals rely on statements from purported experts with financial interests ... the public trust and credibility are at stake.”
Except that it wasn’t the funding that was the problem – it was the absence of ethics by a rogue anesthesiologist.
It’s also important to note that the majority of scientific fraud comes from non-industry sponsored research conducted by academic institutions -- a result of the “publish or perish” survival of the fittest paradigm.
Here’s the full story.
Take this Reuben off the menu.
Now this is a terrible case of ethics abuse – but trying to pin the rap on industry (in this case, Pfizer, Merck, and Wyeth) is quite a stretch.
But that won't stop politicians from trying. After all, nothing like a little Pharma-bashing to get the electorate all hot and bothered. Case in point, Connecticut Attorney General Richard Blumenthal who commented that, “When the public and professionals rely on statements from purported experts with financial interests ... the public trust and credibility are at stake.”
Except that it wasn’t the funding that was the problem – it was the absence of ethics by a rogue anesthesiologist.
It’s also important to note that the majority of scientific fraud comes from non-industry sponsored research conducted by academic institutions -- a result of the “publish or perish” survival of the fittest paradigm.
Here’s the full story.
Take this Reuben off the menu.
They include Mark Helfand who gets the bulk of the comparative effectiveness cash from the federal government, Joe Selby of Kaiser who also gets AHRQ money and Sean Tunis, another AHRQ recipient. Not the least of whom is Alan Garber who compares placing a price tag on human life to putting prices on a menu.
Oh and he gets dough from AHRQ too.
All support using comparative effectiveness studies like the one's AHRQ and HMOs pay them to do to justify saying "no." All that many, so few people. How do you spell conflict? Mark McClellan stands alone a voice of sanity.
Garber wants us to believe that comparative effectiveness leads to higher prices for companies. How about ten solid examples Alan? This from a guy who has spent his life slaving to restrict access to new technologies for the VA, Blue Cross and other insurers.
Oh and he gets dough from AHRQ too.
All support using comparative effectiveness studies like the one's AHRQ and HMOs pay them to do to justify saying "no." All that many, so few people. How do you spell conflict? Mark McClellan stands alone a voice of sanity.
Garber wants us to believe that comparative effectiveness leads to higher prices for companies. How about ten solid examples Alan? This from a guy who has spent his life slaving to restrict access to new technologies for the VA, Blue Cross and other insurers.
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.
