Latest Drugwonks' Blog
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.
Science surprises. To paraphrase Mark Twain, that's because it is not obliged to stick to possibilities while the half-truths spun by some in an effort to displace science have to be immediately and plausibly scary.
So with this said, how interesting that Avandia is the drug used (because of it's insulin producing properties) to determine if "insulin, by shielding memory-forming synapses from harm, may slow or prevent the damage and memory loss caused by toxic proteins in Alzheimer’s disease."
You can read about the research here. Note that neither Steve Nissen or Curt Furberg were asked to comment:
Here
And here.
So with this said, how interesting that Avandia is the drug used (because of it's insulin producing properties) to determine if "insulin, by shielding memory-forming synapses from harm, may slow or prevent the damage and memory loss caused by toxic proteins in Alzheimer’s disease."
You can read about the research here. Note that neither Steve Nissen or Curt Furberg were asked to comment:
Here
And here.
The In Vivo blog makes a good case that the PhRMA approach has been working. But here's the problem ...
The In Vivo observers state:
"The full negative impact on the industry including cost reductions in the private market is estimated at $70 billion over ten years. Compare that to $117 billion that the health insurers are being asked to give up from reductions to Medicare Advantage payment rates and you can see why the health insurers are crying "foul" and complaining that the pain of health reform is falling disproportionately on them."
SInce brand Rx is only 7-9 percent of total health care spending does it make sense for drug spending -- which will come in the form of formulary driven rebates that ultimately hurt the mentally il and seniors the most -- to shoulder such a big chunk.
And that's just the start...
"The fact that cuts to pharma revenues are within the tolerable range combines with the industry's position against smoking to create a good climate for working with the White House, HHS and Congress on two key industry objectives: (1) a well-crafted follow-on biologics bill and (2) control over patient co-pay levels for drugs and biologics."
CBO estimates $70 billion over ten years for FOBs. A lot of the "savings" are expected to come from restricting access to drugs based on comparative effectiveness reviews. Tack on another $100 billion. That doesn't include 15 percent mandatory rebates some in Congress want to stick to drug companies for the privilege of participating in Part D. CBO estimates another $100 billion out of that. Let's round off to $400 billion over ten years or about 25 percent of total revenues for that time period. Add to that the drop off in sales due to patent losses.... As the WSJ health blog noted a while back.... "Generic competition is expected to wipe $67 billion from top companies' annual U.S. sales between 2007 and 2012 as more than three dozen drugs lose patent protection. That is roughly half of the companies' combined 2007 U.S. sales." There will be some offsets thanks to new products but with government policies slashing revenues with rebates, formularies, etc. the combined effect of all these proposals and the generic shift will be huge.
So, is PhRMA just preserving an eroding status quo in order to innovate another day or are buying into policies that will make innovation more difficult given their cumulative impact on the bottom line? It remains to be seen.
Read Article
One thing is certain, I think the In Vivo folks are -- like many so-called "stakeholders" -- confusing having a seat at the table with what is really best for the industry and the public. Especially now when the requirement for keeping that seat is suggesting that even legitimate questions about the direction of health policy are "land mines" that could block the way of the Obama heatlh care express.
Read the In Vivo Blog Here
The In Vivo observers state:
"The full negative impact on the industry including cost reductions in the private market is estimated at $70 billion over ten years. Compare that to $117 billion that the health insurers are being asked to give up from reductions to Medicare Advantage payment rates and you can see why the health insurers are crying "foul" and complaining that the pain of health reform is falling disproportionately on them."
SInce brand Rx is only 7-9 percent of total health care spending does it make sense for drug spending -- which will come in the form of formulary driven rebates that ultimately hurt the mentally il and seniors the most -- to shoulder such a big chunk.
And that's just the start...
"The fact that cuts to pharma revenues are within the tolerable range combines with the industry's position against smoking to create a good climate for working with the White House, HHS and Congress on two key industry objectives: (1) a well-crafted follow-on biologics bill and (2) control over patient co-pay levels for drugs and biologics."
CBO estimates $70 billion over ten years for FOBs. A lot of the "savings" are expected to come from restricting access to drugs based on comparative effectiveness reviews. Tack on another $100 billion. That doesn't include 15 percent mandatory rebates some in Congress want to stick to drug companies for the privilege of participating in Part D. CBO estimates another $100 billion out of that. Let's round off to $400 billion over ten years or about 25 percent of total revenues for that time period. Add to that the drop off in sales due to patent losses.... As the WSJ health blog noted a while back.... "Generic competition is expected to wipe $67 billion from top companies' annual U.S. sales between 2007 and 2012 as more than three dozen drugs lose patent protection. That is roughly half of the companies' combined 2007 U.S. sales." There will be some offsets thanks to new products but with government policies slashing revenues with rebates, formularies, etc. the combined effect of all these proposals and the generic shift will be huge.
So, is PhRMA just preserving an eroding status quo in order to innovate another day or are buying into policies that will make innovation more difficult given their cumulative impact on the bottom line? It remains to be seen.
Read Article
One thing is certain, I think the In Vivo folks are -- like many so-called "stakeholders" -- confusing having a seat at the table with what is really best for the industry and the public. Especially now when the requirement for keeping that seat is suggesting that even legitimate questions about the direction of health policy are "land mines" that could block the way of the Obama heatlh care express.
Read the In Vivo Blog Here
The article (by Jim Edwards) can be found here.
"Interesting" because he (refreshingly) calls it like he sees it -- specifically:
"Peter Pitts, a former FDA official and an executive at Manning, Selvage & Lee, a PR firm that represents pharmaceutical companies, informed producers of his financial ties to drug companies when he appeared as a guest on the show."
Here's what Bill Lichenstein (the producer of the Infinite Mind) had to say about that:
"… as executive producer of The Infinite Mind, I was not the producer of the episode in question. But with regard to our failure to disclose the pharmaceutical connections of one guest, Peter Pitts, Pitts was a guest on the show due to his being a former FDA official. We were not aware, nor was PBS’s NewsHour nor NPR, when they had Pitts on as a guest, of his pharmaceutical PR ties."
So, even though he wasn't aware he was aware. Now that's an infinite mind!
Edwards continues:
That stands in contrast to Pitts’ own assertion, also on BNET Pharma, that he did disclose his ties to drug company clients:
And Edwards ends the article as follows:
"Side note: There’s a slight “Rashomon” aspect as to whether Pitts disclosed his ties to MS&L and drug companies. It should not have mattered, however. Although Pitts was an FDA executive, he is now better known as a pro-industry voice and his clients are not a secret. The only reason Pitts is famous enough to make it onto radio shows is because he is tied to these companies. The mistake here was the show’s failure to do a simple internet search and disclose Pitts’ current job, not with whether Pitts mentioned his job prior to the interview. If you’ve ever met Pitts you’ll know that of all the things you can accuse him of, operating in a subtle, sub rosa fashion is not one of them."
Thanks for the clarification and (I think) the complement.
What remains curious and frustrating is that no one wants to discuss the actual content of the program.
Here is a link to my initial comments on the program (which also include a link to the actual program).
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.
