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Bill would reduce regulatory burdens that unnecessarily delay new medical devices from reaching the market
“It is critical that we don’t allow regulatory burdens to get in the way of delivering lifesaving products to the patients who need them,” Klobuchar said. “This legislation will help ensure that we have processes that promote safe, pioneering technologies that help save lives and create good jobs in Minnesota.”
“In order to provide American patients access to the most cutting-edge medical therapies and advances, we need to fix what is broken at the FDA by restoring regulatory certainty and predictability,” Senator Burr said. “By streamlining and ensuring the least burdensome approach to FDA’s regulation of medical devices, we not only take a key step toward restoring America’s leadership in the research and development of life-saving products, but uphold our promise to patients in North Carolina and around our nation to continue innovating on their behalf.”
“Colorado is a hub of the life science industry and innovation, and we need to work with the FDA to ensure that it modernizes its regulatory system to foster innovation and drive the economy,” said Bennet. “This bill would help provide our nation’s medical device developers and manufacturers with the regulatory clarity and predictability that would give our patients the greatest access to lifesaving products and boost our national economic competitiveness.”
Over the past few years the FDA’s regulation has become increasingly longer and more difficult, delaying, and in some cases preventing, new and innovative devices from reaching the market. Recent studies showed that the average time to approve a 510(k) application has increased 43% from the 2003-2007 period to 2010, and the average time to approve a premarket approval (PMA) application has increased 75%. A recent survey of venture capitalist life sciences investors showed that almost 40% of investors are more likely to shift their operations and investments overseas because of FDA’s regulatory challenges.
The senators’ legislation would help streamline the FDA’s regulation of medical devices by clarifying FDA’s current least burdensome requirements.
These provisions will ensure that when making regulatory decisions on medical devices, FDA focuses only on the relevant information during the decision-making process, considers appropriate alternatives to reduce the time, effort, and cost of reaching regulatory decisions, and uses all reasonable mechanisms to reduce review times when making these decisions.
Because current conflicts of interest restrictions are overly stringent, the FDA is having difficulty finding qualified experts to serve on advisory committees, which can contribute to unnecessary delays for patients. In response to this problem, the legislation would restore the appropriate balance to conflicts of interest requirements by requiring the FDA to be subject to the same conflicts of interest requirements as the rest of the federal government. Finally, the legislation would also direct the FDA to contract with an outside entity to conduct a thorough review of the management and regulatory processes at the FDA’s Center for Devices and Radiological Health, including the impact on medical device innovation.
Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and has been a leader in the effort to cut red tape that threatens innovation in the medical device industry. After a December 2010 report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar also founded the bipartisan Senate Medical Technology Caucus to increase awareness about issues facing the industry.
Bennet, a member of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to FDA Commissioner Margaret Hamburg in August pushing for reformed FDA regulations that foster innovation and competitiveness and position the FDA to serve as a driver of the global economy. Following the letter, Hamburg joined Bennet to hear about innovation and advances in the bioscience industry in Colorado while touring the Colorado Science and Technology Park at Anschutz Medical Campus.
Read More & Comment...
If you think the FDA is dragging its feet on all matters social media, consider what’s happening across the pond.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has declared that it is satisfied (at least so far) with the work of the European Commission on the issue of information-to-patients (ItP). It did, however, suggest that future discussions should examine ways to ensure that high-quality information is accessible to patients in their own language.
What is really lacking in the proposals is any guidance on how companies can address social media - such as Facebook and Twitter - Efpia Director General Richard Bergstrom says.
But Bergstrom is not looking for another directive on this issue, as it may take "years to formulate." He says he hopes that within the framework of the current proposals, some members of the European Parliament will look to address the social media aspect.
"The reason why this has not come up before is that in the first review people were obsessed with the fundamental aspects of whether industry should be permitted to provide information in the first place," he says.
In the meantime, the Commission's proposals regarding information to patients must now be debated once more by both the European Parliament and the Council of ministers, although no timetable for these activities is as yet available.
Vaccines cause neither autism nor mental retardation.
Vaccines have delivered us from a plethora of public health afflictions from polio to pertussis, measles, mumps, rubella and most recently HPV.
Dr. Paul Offit is Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. In addition, Dr. Offit is the Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics at the University of Pennsylvania School of Medicine. He is also the recipient of the Center for Medicine in the Public Interest’s 2011 Odyssey Award for his courageous leadership against the dangerous idiots vaccine denial.
Shortly we will post Dr. Offit’s remarks at the recent Odyssey Awards dinner. But, as a teaser, here’s how he addressed the issue that Representative Michele Bachmann threw at Governor Rick Perry:
“If $5000 can buy a state vaccine mandate – I’m in for $10,000.”
Bravo.
Read More & Comment...Indiana Governor Mitch Daniels
Montel Williams
Dr. Paul Offit
There’s only one thing you need to know about the most recent decision of the United States Preventative Services Task Force claim the PSA set for prostate cancer is useless and the Institute of Medicine’s recommendation that all medical services now and forever should be covered under Obamacare only if they are cost-effective: They both rely on one-size fits all information that ignores racial, gender, cultural and genetic variations that doctors rely on to personalize care and developers of medical technology now use to develop more targeted treatment.
http://www.uspreventiveservicestaskforce.org/uspstf12/prostate/prostateart.htm
http://www.kaiserhealthnews.org/Stories/2011/October/06/iom-essential-health-benefits-package.aspx
The one size fits all approach is tailored to the goal of Obamacare of reducing the cost of government run health care by rationing the use and creation of medical services and products. And the cost-effectiveness benchmark is designed to delay and discourage adoption of new treatments. So for instance, the USPSTF hasn’t considered research showing that certain women should get mammograms as a early as 25 to reduce the risk of breast cancer. And it neglects discussion of next-gen PSA tests called pro-PSA that measures at least three forms of free PSA (called B-PSA, I-PSA, and pro-PSA. These first two forms are decreased in the blood of prostate cancer patients and pro-PSA is increased. ) This test can predict prostate cancer more accurately and earlier.
Pro-PSA will have to go through testing before it is approved by the Food and Drug Administration. But under Obamacare the cost of proving it is cost-effective even for specific groups of patients. This will add millions of dollars to the cost of development and extra years before it’s available. If at all.
Multiply this exercise countless times and before you know it, fewer new drugs, devices and tests will come to market. Since these products often reduce other treatment costs, save lives and increase productive, hindering their development will not save money or make healthcare cost effective or humane. But that is not the goal of Obamacare. The goal is to give government – or rather thousands of bureaucrats and second-rate health economists who do not practice medicine, who never developed a drug or device, who rarely accept responsibility for the damage they cause with their monstrous regulatory certainty – control over decisions our more enlightened overseers believe we are too stupid and greedy to make on our own.
This breathtaking assault on freedom will not stand. But before it falls, people will die. Those who profit from this enterprise in the form of consulting contracts from Health and Human Services and the Agency for Healthcare Quality and Research are and will be to blame. Shame on them. And shame on us for not doing and say more to stop this sick slide into rationing.
Read More & Comment...
Are Politics Driving the CDC’s Pending Decision on an Infant Meningitis Vaccine?
For decades, the Centers for Disease Control and Prevention has championed immunization against a host of deadly diseases. But, now, in a sudden reversal, CDC is signaling it may not recommend the routine administration of a proven new vaccine to prevent infant meningitis, an often fatal disease.
This briefing will feature the release of brand new research evaluating the disparities in how government programs place economic value on human life, as well as testimonies from health care and FDA experts.
Please join us as we examine how and why the CDC may be restricting access to a new meningitis vaccine for infants, and the impact this may have on patient care.
Special Remarks By
The Honorable Michael C. Burgess, M.D.
US House of Representatives (TX-26)
Panelists:
Christopher Stomberg, Ph.D., Partner, Bates White Economic Consulting
Gretchen Moen, RN, MS, CPNP-Pediatric Nurse Practitioner, Eagan Child and Family Care
Richard G. Judelsohn, MD, FAAP-Medical Director, Erie County Department of Health
Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest
Moderated by Merrill Matthews, Ph.D., Institute for Policy Innovation
Event Details:
Friday, October 14, 2011
10:00 am to Noon
Rayburn 2325
Rayburn House Office Building
Capitol Hill, Washington DC
Complimentary refreshments will be served
*This event is widely attended
RSVP to Erin Humiston
erin@ipi.org or (972) 874-5139
Are Politics Driving the CDC’s Pending Decision on an Infant Meningitis Vaccine?
For decades, the Centers for Disease Control and Prevention has championed immunization against a host of deadly diseases. But, now, in a sudden reversal, CDC is signaling it may not recommend the routine administration of a proven new vaccine to prevent infant meningitis, an often fatal disease.
This briefing will feature the release of brand new research evaluating the disparities in how government programs place economic value on human life, as well as testimonies from health care and FDA experts.
Please join us as we examine how and why the CDC may be restricting access to a new meningitis vaccine for infants, and the impact this may have on patient care.
Special Remarks By
The Honorable Michael C. Burgess, M.D.
US House of Representatives (TX-26)
Panelists:
Christopher Stomberg, Ph.D., Partner, Bates White Economic Consulting
Gretchen Moen, RN, MS, CPNP-Pediatric Nurse Practitioner, Eagan Child and Family Care
Richard G. Judelsohn, MD, FAAP-Medical Director, Erie County Department of Health
Peter Pitts, President & Co-Founder, Center for Medicine in the Public Interest
Moderated by Merrill Matthews, Ph.D., Institute for Policy Innovation
Event Details:
Friday, October 14, 2011
10:00 am to Noon
Rayburn 2325
Rayburn House Office Building
Capitol Hill, Washington DC
Complimentary refreshments will be served
*This event is widely attended
RSVP to Erin Humiston
erin@ipi.org or (972) 874-5139
It is no use to blame the looking glass if your face is awry. -- Nikolai Gogol
The survey found that FDA regulatory challenges were most frequently cited as having a significant effect on investment trends.
Blame the FDA? It’s a convenient excuse when sponsors aren’t transparent (I hesitate to say “honest”) about their interactions and communications with the agency.
For example, upon receipt of a Complete Response Letter, many companies issue public statements to the effect of, “We were shocked! The FDA never said there were any problems. We were most definitely expecting product approval.”
Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.” Hogwash.
And when you read the CR, all of a sudden it seems there is often blame to be shared. But, since CRs (and all FDA-sponsor communications) are commercial confidential, sponsors rarely (if ever) offer them with the media or, for that matter (and germane to the NVCA survey), the investment community. Why is that?
Might it be that sponsors make mistakes and that there is (de minimus) blame to be shared? Might it be that companies sometimes try to game the system (accelerated approval issues come to mind) – and fail? Blaming the FDA when corporate strategy flounders is convenient when the agency cannot release (in its own defense) any information.
Might Complete Response Letters be made public? Consider this statement by FDA Commissioner Hamburg when asked whether FDA is discussing unilateral disclosure of information about drug development programs even if a sponsor objects, “It’s a discussion that we’re having, and I think it’s a partnership working with industry. We need to move in directions that make sense, that will have value added, and where everyone understands the expectations and the opportunities.”
Here it is straight from the Bob Temple:
“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”
Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency.
Blame the FDA? Perhaps. But the fault, dear Brutus …
Take your life in your own hand and what happens? A terrible thing: No one to blame. -- Erica Jong
The NVCA also noted that, after FDA issues, the most potent challenge to investors are reimbursement issues.
And that’s another story.
Read More & Comment...But frankly it reads like a publication edited, rewritten and vetted by the FDA's political minders and not the work of scientists. The glossy document spends half it's pages extolling the virtues of activities that have nothing to do with accelerating the development of new products through cheap and easy to use tools and metrics. Rather, we get a roll call of Obama administration initiatives such as Startup! America, the FDA Small Business Liaison Program, Young Entrepreneurs, Partnering with the Small Business Administration and programs with one time funding from the stimulus bill. Taken together they are a Potemkin Village to divert attention to the increasing regulatory uncertainty flowing from comparative effectiveness research requirements, projected cuts in reimbursements and other features of the new health care law that undermine innovation.
When the report discusses activity that the FDA will undertake to 'drive innovation' it largely restates work already underway. To be fair, efforts to integrate the use of biomarkers, adaptive trial designs, etc., that could accelerate development of drugs and devices takes time. Often companies, fearing it could actually doom a product by using new approaches, simply load up on old ones. But by the same token when you have the FDA demanding more safety data on the back and front end of the regulatory process and certain divisions change endpoints, revoke approvals and raise the bar so high as to make approval unlikely -- think drugs for obesity and diabetes and Avastin -- a 37 page brochure celebrating 'regulatory science' and 'partnerships' should make anyone who follows the FDA highly skeptical of real progress. Which means that specific initiatives to accelerate targeted treatments and combination products -- initiatives that were launched in 2004 under the Critical Path Initiative -- will need it's own targeted effort to be adopted.
And even here driving innovation is undermined by the stealth effort to turn the FDA into an accomplice of those seeking to use comparative effectiveness research as rationing tool:
"FDA has launched the Partnerships in Comparative Effectiveness Science (PACES) program to support the development of new mathematical methods to support patient-centered outcomes research. PACES provides funds to pilot out the technical, infrastructure, scientific and legal constructs that will be used as foundations for science computing communities involving FDA scientists and data. These activities will support scientifically sound assessments of medical interventions consistent with FDA’s public health responsibilities."
The PACES program is nothing but the mathematical manipulation of claims data -- data that tells you nothing about differences in patients -- to create the illusion that you are truly measuring differences in patients. The FDA's solicitation for the PACES program begins:
"CER could extend beyond the application of specific intervention methods to controlled clinical trials or within specific health care settings. For example CER could be used to better understand what interventions work best for individuals and subgroups within populations."
Let it be noted that there is already a lot of this sort of analysis included in clinical trials already. So why do we need another initiative of this nature? The solicitation explains:
"Both pre- and post-approval data collected and housed at the FDA can be combined with other datasets on long term health outcomes that reside in other agencies or the private sector. As personalized medicine develops, FDA expects an increase in the need for comparisons across products (and associated delivery mechanisms) to define how these products should be used in combination for individualized health care before and after FDA approval."
Does this sound like an requirement that will speed up product development. Why should clinical trials to compare response across products (CER) be a requirement for FDA approval? Why should it be a requirement after FDA approval? The additional cost and time of such trials will be hugely expensive. At least $100-$200 million per product. And by requiring the use of algorithms derived from claims data, the FDA guarantees that detection of no differences when in fact they exist in the real world.
Worse, the FDA's Janus project, an effort to standardized the submission of patient-level data to expedite biomarker development and promote smaller trial designs is being hijacked for CER purposes (from the PACES solicitation):
• Component 1- The Contractor shall plan and organize the CER project with FDA stakeholders, including participation in annual FDA-hosted planning workshops (three workshops, two days each) to define candidate CER questions and priorities, analyses strategies and datasets to be utilized.
• Component 2- The Contractor shall provide training on methodologies developed to FDA staff during two of the FDA-hosted planning workshops.
• Component 3 - The Contractor shall identify or develop appropriate analytic methodologies for CER and apply them to FDA and/or other data; develop new scientific computing strategies and hone existing computational strategies to perform these CER analyses. The Contractor shall prepare reports and manuscripts of the results suitable for publication in scientific journals.
• Component 4- The Contractor shall develop innovative clinical trial design strategies for prospective CER clinical trials and analyses of healthcare data including providing formal recommendations for best practices for submission of studies to the FDA when they involve product comparisons. These strategies and recommendations shall be documented in reports and manuscripts suitable for publication in scientific journals.
Even if all the happy talk about driving innovation was real, it could all be undermined by this effort to use FDA's most significant data program into a tool for rationing. It will drive innovation all right, off a cliff.
I believe that senior leadership at the FDA from Commissioner Hamburg on down have the best of intentions. And I know for a fact that Janus and other activities undertaken in response to the Critical Path were to be used to bring new and better products to market with greater speed and at less expense. It's those who want to slow down the development and adoption of innovation and who have politicized the FDA with CER claptrap that are at fault. They think they know better and their monstrous certainty will kill innovation for decades to come.
Read More & Comment...
The FDA has released a new “blueprint” document, “Driving Biomedical Innovation: Initiatives for Improving Products for Patients,” containing immediate steps that can be taken to drive biomedical innovation.
Addressing the sustainability of the medical product development pipeline, which is slowing down despite record investments in research and development, FDA Commissioner Peggy Hamburg comments, “America is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and to promote better health for the public. Our innovation blueprint highlights some of the initiatives FDA will be implementing to ensure that these opportunities are translated into safe and effective treatments that can help keep both American patients and American industry healthy and strong.”
The report’s proposals stem from a review of FDA’s current policies and practices, as well as months of meetings with major stakeholders nationwide, including key industry leaders, small biotech, pharmaceutical and medical device company owners, members of the academic community, and patient groups.
The blueprint focuses on implementing the following major actions:
• rebuilding FDA’s small business outreach services
• building the infrastructure to drive and support personalized medicine
• creating a rapid drug development pathway for important targeted therapies
• harnessing the potential of data mining and information sharing while protecting patient privacy
• improving consistency and clarity in the medical device review process
• training the next generation of innovators
• streamlining and reforming FDA regulations.
The complete report can be found here.
An important read. But it’s got to be more than rhetoric. Read More & Comment...But then again, The Shink probably has insights we cannot share. He was the ace reporter of Marijuana Business Reporter, a job he was recruited for. Actually he found the job on Craigslist. Which is fitting in so many ways. Nothing like finding a job while checking out garage sales and massage parlors. But I digress. In addition, The Shink broke new journalist ground with his Irony Supplement blog. Get it? Irony (as in iron) Supplement? If Twain were alive he would be jealous. Here is a sample of The Shink's writing skills and prophetic reporting gifts:
Why Bernard Madoff Should Face The Death Penalty
A rational discussion as to why disgraced financier Bernard Madoff should face capital punishment.
Father Limbaugh?
A comparison of Rush Limbaugh and Charles Coughlin's political tactics.
And my favorite..
Hurry Up And...@*&%# WAIT?!?!?
An examination of the media's dementia in covering the stimulus package. (This is where The Shink attacks the media for doubting the benefit of the stimuls and not believing the recession was over in 2009 when The Shink said it was.)
Why do I bother with such a bottom-feeding paranoid? Because he writes for what once was and should be a respectable online publication that cares about the mindset and journalistic stability of it's editors.
I hope The Shink has to hit Craigslist for work real soon. He shouldn't have a problem getting another job. After all, the recession is over, isn't it? Or maybe BIG PHARMA is cooking up that crisis too.
Read More & Comment...
“I don’t want any yes-men around me. I want everybody to tell me the truth even if it costs them their jobs.” -- Samuel Goldwyn
Important article in the October edition of Southern California Physician, “The Devil in the (Academic) Details.”
Some verbatims:
Since they are not employed by a pharmaceutical company nor do they receive incentives from them, then they must be completely unbiased, right?
Not so fast.
“Of course more information is always better,” says Peter Pitts, President of the Center For Medicine in the Public Interest, a nonprofit, nonpartisan research and educational organization that seeks to advance the discussion and development of patient-centered health care. “But to argue that academic detailing is “pure” is absurd. The information being shared is only as good as those sharing.”
Pitts says that the Patient-Centered Outcomes Research Institute—a research organization dedicated to the support and promotion of comparative clinical effectiveness research, which was created through the Patient Protection and Affordable Care Act—plans to offer Continuing Medical Education Credits to physicians who meet with academic detailers. The practice is potentially dangerous if the academic detailers are acting in the interest of government’s push to drive down health care costs, for example by promoting generics over other new types of drugs.
The Real Bottom Line
Whether you are a fan of academic detailing or not, the bottom line is that federal and state governments are driving and funding the effort. And it is clear that they are tasked with reducing the cost of health care, even if it is not necessarily in the best interest of the patients.
If you get a visit by an academic detailer, keep in mind that they may not be any less biased than a pharmaceutical representative and they definitely do not have to follow the same rules.
The complete article can be found here.
Read More & Comment...Last week the wsj editorial page artfully described how comparative effectiveness research is being used to justify government deciding what medical technologies will be developed and what treatments we will receive:
What the editorial implied but not discuss is that CER methodology is used to 1) establish that a drug will work but that 2) the cost of the treatment is "not good value for money". Which means 'society', meaning government-paid CER munckins say it's not worth paying for the treatment. In 1994 NICE decided that the cost of Cerezyme, the first treatment for Gaucher's for the ‘average’ Gaucher’s disease patient exceeds the normal upper threshold for cost-effectiveness seen in NHS policy decisions by over ten-fold."
In a similar vein, Alan Garber suggests that individual response to new treatments should not be considered in determing what benefits health plans should cover under Obamacare because if we add every new techology that "is proven effective" would result in a "costly bundle of services." Cue the CER experts to decide what services and treatments are valuable and which are not, even if they help people live longer healthier lives. Garber also urges the US to adopt the CER tools used around the world.
WIth that in mind, here's how NICE, the Nirvana of the CER crowd handles Benlysta, the first new drug in 50 years to treat lupus:
"Lupus drug Benlysta from GlaxoSmithKline PLC (GSK, GSK.LN) and U.S.-based partner Human Genome Sciences Inc. (HGSI) doesn't represent value for money and should therefore not be made available on the publicly-funded National Health Service, Britain's healthcare watchdog NICE said on Friday.
Benlysta, or belimumab, is the first new lupus treatment in 50 years. It won U.S. marketing approval in March and European approval in July. Lupus is a chronic autoimmune disorder, with symptoms ranging widely in type and severity. An estimated five million people worldwide have the disease.
In draft guidance, the U.K.'s National Institute for Health and Clinical Excellence said, "NICE's independent appraisal committee has looked very carefully at the evidence provided on the use of belimumab for treating SLE [Systemic lupus erythematosus], including the views of people with the condition, those who represent them, and clinical specialists.
"The evidence considered did not persuade the committee that belimumab was good value for money compared to standard care, as the cost per year of improved health is very high."
NICE also said Benlysta should be compared with rituximab, sold by Roche Holding AG (ROG.VX), because some people with severe lupus currently receive rituximab, although it isn't licensed for this use. However, NICE noted there were no reliable data to show the relative efficacy of the two drugs.
"Whilst recognizing the severity of the disease, the committee concluded that based on this evidence, belimumab could not be considered a good use of NHS resources. We welcome comments on this draft recommendation as part of the consultation," the agency said. The draft guidance is now open for consultation before further decisions on the medicine are made.
Glaxo said it was disappointed by the agency's stance.
"This initial decision is very disappointing for patients living with lupus who currently have very limited treatment options and we will do everything we can to change NICE's mind in an effort to ensure they get access to Benlysta on the NHS," said Simon Jose, General Manager, GlaxoSmithKline UK.
"NICE's current methodology means that it is difficult to meet their cost-effectiveness threshold given the nature of the disease and the comparison with unlicensed or cheap generic medicines. We had hoped that our offer of a patient access scheme would help overcome these challenges," Jose added.
Navid Malik, an analyst with Merchant Securities, echoed that surprise, saying, "It seems incredulous for NICE to say that just because patients are on Rituxan for Lupus, they should not be reimbursed and given Benlysta, (as) Rituxan doesn't work in Lupus and yet Benlysta has been shown in two phase III trials to work."
Read More & Comment...
Proposed Swedish Pharma Pricing Model Suggests VBP Is Not Enough To Control Costs
The Swedish government published on Sept. 22 a framework directive designed to revolutionize the pricing, reimbursement of and access to patent-protected pharmaceuticals.
This will alarm pharma manufacturers that the VBP systems now being implemented by countries such as Germany, France and the U.K., simply may not go far enough in terms of controlling costs and that harsher measures may follow.
The directive examines the possibility of introducing a mechanism that would ensure that drug prices in Sweden are below or the same as prices in other comparable countries such as Norway, Great Britain and Denmark - known as a reference pricing system, the government suggests it could lead to annual savings of between SEK 500 million ($74 million) to SEK 2 billion ($294 million).
Sweden also is examining the possibility of introducing reimbursement limits for certain products - which should generate savings of SEK 900 million over a three-year period. The Rapporteur's report will be presented to government on Sept. 1, 2012.
"This implies that some of the proposals could be implemented as soon as in the beginning/middle of 2013," said Anders Blanck, Director General of the Swedish pharmaceutical industry association, Lif.
tinyurl.com/4y67ndh
Read More & Comment...
Today's news that Blue Shield of California will no longer pay for Avastin to treat breast cancer, though "exceptions may be considered on a case-by-case basis," makes a new nationwide survey by the Coalition of State Rheumatology Organizations (CSRO) big news. The survey shows broad dissatisfaction with the insidious practices of preauthorization and step therapy – specifically the ways in which it impacts the ability of physicians to treat patients.
(Prior authorization, also known as pre-authorization, pre-certification or prior notification, is an extra set of steps some insurance carriers require before determining whether they will pay for a medical service or prescription medication. The physician, or other medical provider, is required to obtain approval from the insurance carrier before the carrier will agree to cover the cost of the medical service or prescription medication. Step therapy, also referred to as “fail-first,” requires patients to “fail’ on one or more less costly medications before the health insurance carrier will agree to cover a more expensive medication, even if a physician thinks it is a better option for the patient.)
“Rheumatologists around the country have increasingly voiced their concerns about the impact of health insurance protocols such as prior authorization and step therapy on patient care,” said Reuben Allen, CSRO Executive Director. “These practices are stripping rheumatologists of the ability to direct the most appropriate and effective courses of treatment, which causes patients to suffer delays or outright denials of proper medical care. Individualized treatment plans that can restore, enhance, and preserve quality-of-life over time are essential to rheumatology patients and their struggle against autoimmune and destructive arthritic disorders.”
Specific findings of the CSRO survey include:
Nearly 99% of rheumatologists surveyed say they have had to alter treatment plans including changing prescription medications to accommodate restrictions imposed by patient health insurance carriers;
91.5% of survey respondents say prior authorization has a “negative” to “very negative” effect on their ability to treat patients;
Nearly 97% of rheumatologists surveyed agree, “There should be enforceable legislation to regulate restrictions that insurance companies place on health care providers in regards to treatment modalities they prescribe for their patients;”
Nearly 98% of survey respondents agree that decisions about what medications are best for a patient should be made by the patient’s own health care provider and not by the health plan or insurance company;
Nearly 73% of respondents say they are only “sometimes” or “rarely” able to easily determine what procedures will be covered by a patient’s health plan at point-of-service;
52.2% of rheumatologists surveyed say they have considered re-establishing their practices as fee-for-service only because of prior authorization constraints.
Currently, prior authorization and fail-first protocols are primarily paper-based, and non-standardized. Each insurance carrier has its own set of requirements, which can vary among plans, even within the same carrier’s portfolio of coverage options. To meet prior authorization requirements physicians must complete a time-consuming series of faxes, phone calls, emails, input of data into insurance carrier web sites and, in some cases, letters.
Prior authorization should be standardized and improvements in the current process can be made by the adoption of a universal prior authorization form;
Electronic prescribing platforms are provided on neutral and open platforms that do not advance the commercial interests of any particular participant (e.g., health insurers, hospitals, pharmacy benefits managers, pharmaceutical companies, etc.) to the potential detriment of the patient;
Adjudication of prior authorization requests occurs within a reasonable time frame (hours as opposed to days or weeks); and communication between physicians and payers should be on a peer to peer basis;
Electronic prescribing platforms include access to information about all FDA-approved medications and medical services without restrictions;
Complete, up-to-date information about prior authorization and fail-first criteria is available through electronic prescribing platforms at point-of-service;
Prior authorizations should not be required on a repeated basis. It should only be necessary with a change in medication dictated by a change in clinical status;
Prior authorization should not be necessary for low cost medications; for example, prednisone and methotrexate.
“Physicians are responsible for the administrative costs associated with meeting prior authorization and fail first requirements.
“Prompt diagnosis and specially tailored treatment can improve the long-term outcomes of patients with rheumatologic diseases," said CSRO's Allen. "State legislatures and insurance commissioners should take appropriate steps to ensure that patients suffering from chronic rheumatic diseases and chronic pain do not have to needlessly suffer.”
The complete CSRO survey can be found at http://www.csro.info/
Read More & Comment...In April, the Food and Drug Administration approved a first-of-its kind study to test whether marijuana can ease the nightmares, insomnia, anxiety and flashbacks common in combat veterans with post-traumatic stress disorder.
But now another branch of the federal government has stymied the study. The Health and Human Services Department is refusing to sell government-grown marijuana to the nonprofit group proposing the research, the Multidisciplinary Association for Psychedelic Studies.
The HHS official in charge of the review, Sarah A. Wattenberg, declined to answer questions when reached by phone.
Can you imagine the hue and cry if this had happened under the previous administration?
Read More & Comment...Embed head firmly in sand and repeat after me in your best Dorothy in Oz cadence, “Pens and Pizza and Biscuits. Oh my!”
Now consider this new British Medical Journal commentary piece by Iona Heath, the president, Royal College of General Practitioners” --
The politics of drug industry sponsorship
Earlier this month I received a letter from a senior politician inviting me to attend a meeting on a public health topic … I failed to notice that the letter included the sentence: "The meeting is being supported by the healthcare company, Bristol-Myers Squibb." However, when I arrived, the tabled agenda had a similar sentence across the bottom: "The logistical aspects of this meeting are being supported by Bristol-Myers Squibb (BMS)."
The usual round of introductions revealed that there were two representatives of the company in the room listening to everything that was being said … Although I welcome unreservedly the transparent disclosure, when I tried to express concern about the process, the said politician assured me, more than a little abruptly, that it was only the coffee and the biscuits … Not surprisingly, the biscuits were much more tempting than usual … Sadly the politician in question seemed not to be aware of the relevance of any of this to the coffee and biscuits.
Dr. Heath’s complete commentary can be found here.
Sadly Dr. Heath (while certainly entitled to her opinion and desire to tow the party line) seems unaware of the evidence to the contrary.
For example, in the January 2010 issue of Academic Medicine (Adad. med. 2010; 85:80-84), four researchers from the Cleveland Clinic published a paper entitled, "The Effect of Industry Support on Participants of Bias in Continuing Medical Education." The purpose of the study: "To obtain prospective evidence of whether industry support of continuing medical education affects perceptions of commercial bias in CME."
The method: "The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multi-specialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support."
The study's conclusion: "This large prospective analysis found no evidence that commercial support results in perceived bias in CME activities. Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present."
Further, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest. Here's the key paragraph:
"There is no inherent conflict of interest in the working relationships of physicians with industry and government. Rather, there is a commonality of interest that is healthy, desirable, and beneficial. The collaborative relationship among physicians, government, and industry has resulted in many medical advances and improved health outcomes."
What a unique perspective -- a "commonality" rather than a "conflict" of interest.
And in a recent editorial in The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research, and the pharmaceutical industry are artificial at best—and dangerous at worst. They are dangerous, because all three constituencies are working towards the same goal—improved patient outcomes.
His point is that we must dismantle the battlements and embrace of philosophy of “symbiosis not schism.” It’s what’s in the best interest of the patient.
Nature Biotechnology puts it this way, “The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress.”
Suffice it to say that we disagree with Dr. Heath’s position – but we will certainly defend her right to have an opinion and express it.
Alas, the same cannot be said for another fellow traveler – Dr. Steve Nissan.
Recently my friend and co-conspirator Dr. Tom Stossel (the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women's Hospital) was invited to give a Grand Rounds lecture given at Case Western University. Here’s the verbatim e-mail that Dr. Nissen sent to his colleagues at Case Western:
“This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds. Your trainees deserve better.”
Talk about professional discourtesy!
The good news is that Tom’s lecture was standing room only.
Read More & Comment...Yesterday I was honored to attend and participate in the 2nd annual Galien Forum (part of the Prix Galien celebration). The topic under debate for my panel was, “What is value and how can it be measured and demonstrated in therapeutic innovations?”
I was joined on the dais by Jeff Berkowitz (SVP, Pharmaceutical Development and Market Access, Walgreens; Robert Epstein, Chief Clinical Research and Development Officer, Medco; Barry Gertz, SVP, Head of Clinical Research and Regulatory Affairs, Merck; and Roger Longman, CEO, Real Endpoints. Our moderator was Dick Pasternak, a former Merck VP, Harvard Medical School associate professor and past director of Preventive Cardiology at Mass General).
The combination of a meaty topic and a high-octane panel made for a robust conversation. When the video of the panel is available, I will post it.
The audience was engaged and one question was particularly thought provoking. Not surprisingly, it came from Nobel Laureate Dr. Michael Brown (Professor of Molecular Genetics and Internal Medicine at UT Southwestern Medical Center and a board member of Pfizer). Dr. Brown asked why innovative companies like Apple have such high public esteem while innovative pharmaceutical companies are at the other end of the spectrum of public opinion.
Perhaps the answer (or at least a piece of the answer) is that Apple defines itself in terms of innovation and the value it brings. How, in contrast, do pharmaceutical companies (and the people who populate it) define themselves? Too many see their jobs as “selling drugs.” And while that is certainly a part of it (and an important and worthy part at that) should that be how they define their jobs and their employers?
Until and unless pharmaceutical companies and their employees define themselves as being in the advancing healthcare business (as all their mottos proclaim), they will not be given the credit for the innovation that they truly deliver.
Many believe such image issues are the responsibility of PhRMA. And while the trade organization certainly has an important role to play, ask yourself this – does Apple rely on its trade association to promote its innovativeness?
Another panel featured (among others) Dr. Steve Nissen on the topic of “Perspectives on Innovation, Patient Safety and Global Access.” Here’s one direct quote from Dr. Nissen:
“No one should ever stop taking a medicine because of something they saw on television.”
Please pass the remote.
Read More & Comment...“Every time I put my line in the water I said a Hail Mary, and every time I said a Hail Mary I caught a fish.” Fredo Corleone
To use a pop culture metaphor, if IPAB is Michael, MedPac is Fredo.
The Medicare Payment Advisory Commission (aka – MedPac, the body that advises Congress on Medicare payment policy) is proposing to fix the Sustainable Growth Rate by sharing the cost of repealing the SGR among physicians, other health professionals, providers in other sectors and beneficiaries.
MedPAC’s draft plan suggests instituting a 10-year payment rate freeze for primary care physicians and three years of reduced payments at 5.9 percent each for specialists followed by a seven-year payment freeze. It also recommends offsets totaling about $235 billion. Those offsets would come from cuts to Medicare Part D drug plans (32 percent); post-acute care facilities (21 percent); Medicare benefits to seniors (14 percent); hospitals (11 percent); laboratories (9 percent); durable medical equipment (6 percent); Medicare Advantage (5 percent).
Not surprisingly, physicians are none too thrilled about the proposed cuts and freezes to their payment rates. In a statement, the American College of Surgeons said that, “The recommendations do not value the role all physicians have in the continuum of care and would have a devastating impact on access to surgical care.”
It certainly took long enough the physician community to stand up and speak out for patient care. Too bad it took the harsh realities of the bottom line to do it.
Read More & Comment...Avorn claims that academic detailing is "evidence based medicine" put to use. But their is very little evidence that anti-innovation detailing improves the health of patients. There are no large scale clinical trials to look at the effect on health outcomes. Or should we just take Avorn's word that his business model is better? A study last year seemed to suggest that doctors who were subject to marketing to use the guidelines from ALLHAT and prescriibe diuretics as the treatment of choice for high blood pressure were more likely to do so. Let's ignore the fact that the claim diuretics reduced death as well or better than other drugs is based on based on secondary endpoints and that the primary endpoint (fatal coronary heart disease and nonfatal myocardial infarction) was similar for the 3 drugs. ALLHAT guidelines also hurt minorities: ALLHAT steered African-Americans to a combination of an ACE inhibitor and a [beta]-blocker in black patients. Blacks randomized to an ACE-inhibitor had 40% excess stroke rate compared to whites which explains the overall benefit of diuretics found in ALLHAT.
So Avorn peddles a protocol whose design kills black patients. He also opposed the FDA approval of BIDil -- combination of two drugs that showed overwhelming reduction in death from heart failure among blacks until scientists conduct a study that tells us why white and black patients differ in response. In doing so he ignored 3 well-controlled trials suggesting or showing a mortality benefit in black patients. As the FDA noted in response to Avorn the was "apparently unimpressed by the 43% mortality risk reduction demonstrated.. and apparently believed that the racial difference hypothesis was based on a post hoc analysis of a single trial." www.annals.org/content/146/1/57.full#ref-list-1
Actually Avorn is not only not unimpressed, he doesn't care. He makes money pushing cheaper drugs and ignoring evidence that would undermine his racket. If it harms minorities in the process, well that's just a cost of doing business.
Read More & Comment...
Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely.
And not just because of certain high profile LOE dates.
A new draft guidance (issued Sept. 16th) provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. The Pink sheet opines that “support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.”
“Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised.”
Can a patient self-diagnose and self-dose? Do symptoms hide another, potentially more serious, underlying condition? And what of safety concerns?
Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.
A BTC category would almost certainly reopen the conversation about the “statin quo.”
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
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