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Representative Brett Guthrie (R-KY) introduced a bill (H.R. 3827) that would repeal the Patient-Centered Outcomes Research Institute and funding for comparative effectiveness research. The bill was referred to the Committee on Ways and Means, the Committee on Appropriations, the Committee on the Budget, and the Committee on Energy and Commerce. It was co-sponsored by Reps. Dan Benishek (R-Mich.), Joe Barton (R-Texas), Marsha Blackburn (R-Tenn.), Cathy McMorris Rodgers (R-Wash.) and Mike Rogers (R-Mich.).
Other feautres of the study that now characterize most AHRQ 'research.'
No mention of genetic tests or variations that can stratify and optimize treatment.
Conducted by the same people who dole out money to other AHRQ grantees and sit on the PCORI board and who also sit on CER boards of HMOs. (Naomi Aronson). If someone from a device or drug company was a co-author of a study funded by an agency whose decisions they would derive benefit from, Merrill Goozner and Gary Schwitzer (the wholly owned subsidiary of Health Dialog) would mutate into another life form. Oh, I forgot to mention that AHRQ is also hiring drug reps to peddle this stuff to doctors and hospitals.
How about some oversight on AHRQ's activities en route to cutting its budget or reordering it's mission?
http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=945
NPC should be commended for its pathbreaking investment in studies that seek to make medicine truly patient-centered. Here's a link to the NPC press release describing the research:
http://www.npcnow.org/Public/Newsroom/Press_Releases/2012pr/2012five_research_projects_pr.aspx
-- John Adams
On the last working day of the year (December 30, 2011), the FDA approved Prevnar 13 (a pneumococcal 13-valent conjugate vaccine) for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. In fact, the new use for Prevnar 13 was approved under the agency’s accelerated approval pathway, which allows for earlier approval of treatments for serious and life-threatening illnesses.
(The Centers for Disease Control and Prevention reports that 5,000 adults die from pneumonia every year.)
And to drive home the importance of this action, the FDA issued a press statement on the approval before heading home for the long weekend:
“According to recent information for the United States, it is estimated that approximately 300,000 adults 50 years of age and older are hospitalized yearly because of pneumococcal pneumonia,” said Karen Midthun, M.D., director of FDA’s Center for Biologics Evaluation and Research. “Pneumococcal disease is a substantial cause of illness and death. Today’s approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Not so fast.
Although it’s quite a high hurdle to have a vaccine approved by the FDA (and appropriately so), it’s not the final hurdle in getting it to patients. That final hurdle resides with the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP).
ACIP’s charge is to “provide advice and guidance to the Secretary, HHS, the Assistant Secretary for Health, and the Director, CDC, regarding the most appropriate selection of vaccines and related agents for effective control of vaccine-preventable diseases in the civilian population.”
The ACIP meets three times a year, and during these meetings newly licensed vaccines are discussed and a vote is taken to include (or not include) the new vaccine on the adult immunization schedule. ACIP’s recommendations become a basis for reimbursement by public and private payers who will pay for vaccinations that are part of the committee’s recommendation -- but generally not otherwise. The CDC schedule plays an important gatekeeper role for vaccines that goes well beyond the scope of FDA approval. Vaccines approved by the FDA but not appearing on the CDC routine vaccination schedule are likely to gain little traction because of a lack of guidance to providers on how to use the vaccine -- and lack of payer coverage.
In other words, minus a positive ACIP recommendation, a disease that is responsible for approximately 200,000 emergency room visits a year will continue to harass patients and haunt our healthcare system. Minus a positive ACIP vote, new and potentially life-saving vaccines are redlined and another nail is hammered into the coffin of innovation.
The FDA recognized the importance of the adult indication for Prevnar 13 (currently the only vaccine for pneumococcal bacteria approved in the United States for adults 50 years of age or older is Pneumovax which is only effective against invasive pneumonia and not effective on the more common, pneumococcal pneumonia. Prevnar 13 is a conjugate which means it contains a pneumococcal bacteria bound to a protein to help the body’s immune system recognize the bacteria and will have a longer lasting immune response), but at the upcoming ACIP meeting (February 22-23), there is only a discussion of 13-valent pneumococcal conjugate vaccine. Just discussion. That’s important – but a positive recommendation is crucial. Otherwise it is, in many unfortunate respects, just talk.
The need for this patient population exists. The vaccine is safe and effective. Without a recommendation the vaccine will not be available to a large swath of Americans. It’s time for ACIP to call the question.
The battle against the “dangerous idiots” of vaccine denial is dangerous enough, we must avoid the equally daunting danger of … inertia.
As the saying goes, “Truth fears no questions.”
Hence, Ken Abramowitz, our guest blogger reminds us of the pitfalls (and pluses) of Obamacare. Ken is a co-founder and Managing General Partner of NGN Capital. He joined NGN Capital from The Carlyle Group in New York where he was Managing Director from 2001 to 2003, focused on U.S. buyout opportunities in the healthcare industry. Beginning July 2003, he transitioned to Senior Advisor at Carlyle in order to devote the time necessary to create a dedicated healthcare fund on behalf of Carlyle. Prior to joining Carlyle, Mr. Abramowitz worked as an Analyst at Sanford C. Bernstein & Co. where he covered the medical-supply, hospital-management and HMO industries for 23 years, after which he was an EGS Securities Healthcare Fund Manager.
We look forward to his future posts on health care reform and medical innovation.
ObamaCare imposes European socialism “lite” on the U.S. The plan involves 2,800 pages of legislation and, soon, 10,000-15,000 pages of regulation. It is a massively underfunded $900 billion program that relies on stealing $500 billion from a grossly underfunded Medicare program and it does not recognize the $200 billion cost of offsetting the 21% Medicare physician cut.
Rather than making medicine more affordable, It will bend the cost curve upward by taxing insurance carriers, medical device companies, and pharmaceutical companies. It also raises costs in the individual market by imposing insurance mandates (guaranteed issue, narrow underwriting bands, no lifetime benefit limits).
Worse it sets up grossly underfunded individual insurance exchanges that will quickly exceed projected spending. therefore they eventually seek to control cost under dysfunctional price controls. Thereafter insurance carriers will exit the market, tempting the government to take over as it did after the collapse of the housing market. These exchanges offer a costly defined benefit that is 65% subsidized by Federal and State governments, but should have been financed by a more affordable defined contribution.
On the positive side, the bill does provide genuine subsidies to finance and facilitate the “meaningful” use of EMRs and IT integration. On the really positive side, the massive government overreach we will see voters continue to reject Obamacare as they did in 2010. Hence, while the plan is guaranteed to blow up by 2015 fortunately 50% of the bill will be repealed before then. Though no one knows which 50%.
Didn't we hear that in the 1970s when people like Emanuel were predicting insurance companies would become obsolete and be replaced by HMOs that would manage health and improve outcomes?
The faith in administrative changes or addition of regulation to improve, shape, control human behavior is particularly strong among health care policy experts of all stripes. I believe that it is technological progress that makes certain types of care -- fee driven, intermediate or palliative treatments produced through hardware or in hospitals -- obsolete. Think of how infectious diseases were generally treated less than 50 years ago, the use of medicines instead of institutions for people with mental illness, same day surgery vs. the 5 day stay.
ACOs were designed to be conduits for government produced guidelines that are biased against new technology. They are organized against innovation, not to capitalize on it.
As a result, I believe by 2020 not only will the current form of underwriting be obsolete -- because of advances in personalized medicine and direct to consumer delivery of healthcare -- but so will ACO's and Obamacare. If you think it was surprisingly easy to overthrow Arab dictators wait till you and I know more about our health sooner than government bureaucrats who produce outdated guidelines and mandates.
Here's a link to Zeke's article:
http://opinionator.blogs.nytimes.com/2012/01/30/the-end-of-health-insurance-companies/?nl=opinion&emc=tya1
It's true that the cost of sequencing continues to follow Moore's law -- exponential decline in material and equipment costs and increased computing power -- so that what Illumina does with supercomputers is something that doctors and patients will be able to do with smartphones. But Roche is not interesting in the hardware of sequencing. If it did, it could just buy a bunch of machines for a lot less that $5.7 billion.
In fact, Roche knows that sequencing will become commonplace. I think it wants Illumina because of it's partnerships with clinical labs worldwide to perform sequencing. Distribution for Roche diagnostics and products -- as the firm focuses on targeted therapy -- is more valuable than equipment or sequencing. Roche also sells glucose kits too and find that marketplace pretty lucractive.
Should Illumina sell? I don't know and have no opinion. However, I remember when Yahoo snubbed a Microsoft acquisition for a hefty premium over it's share price. Now Yahoo is scrambling to find a buy at a share price far below that offer. Information is quickly becoming a commodity in health care. In 10 years drug companies will be delivering individual content directly to consumers to treat illness. Perhaps Roche believes it can be a source of revenue growth. In any event, acquiring Illumina is about how medical care will be organized in the future, not about it's microarrays now.
Update on the Office of the Center Director and Office of Drug Evaluation1
CDER Staff:
I want to update you on recent changes in my Immediate Office to further enhance medical and scientific decision-making across CDER. These changes also affect the Office of Drug Evaluation 1 (ODE1), Office of New Drugs.
I have asked Robert (Bob) Temple, M.D., to give up his role as the Acting Director of ODE1, so that he can devote more of his time and vast expertise to his other role as the Deputy Center Director for Clinical Science. Ellis Unger, M.D., currently the Deputy Director of ODE1, will serve as Acting Director of ODE1. Bob will continue as Acting Deputy Director of ODEI and plans to maintain substantial (but somewhat less) involvement in ODEI activities.
In November 2009, due to the growth of the Center’s responsibilities, I appointed Bob as the Deputy Center Director for Clinical Science with primary responsibility for high level initiatives and programs related to clinical science and clinical trial methodology issues. At that time, Bob agreed to wear two hats and continue as Acting Director of ODE1.
As Deputy Center Director for Clinical Science, Bob has played and continues to play a major role in directing and executing many cross-cutting CDER functions, which enhance the quality and consistency of our operations. Now he will have more time to further provide valuable regulatory input and methodological assistance across the Center.
I am grateful to Bob for serving ODE1 with excellence and superb leadership. I also am grateful that we have someone like Ellis to step in and assume the Office Director position on an Acting basis. Ellis has been with CDER since 2004, serving in various leadership roles, and in the ODE1 Deputy Director capacity since August 2008. I am confident that he will continue to serve ODE1 exceptionally well.
Janet Woodcock
Really interesting issue brief from CBO regarding approaches taken in various projects that help in attainment of demonstration goals:
Gather timely data on the use of care, especially hospital admissions. Programs that collected timely data on when their patients’ health problems developed or became exacerbated and where they were treated seemed better able to coordinate and manage their patients’ care. Those efforts could be strengthened if CMS improved its capability to provide programs with timely data on their patients’ use of services.
Focus on transitions in care settings. Programs that smoothed transitions (for example, by providing additional education and support to patients moving from a hospital to a nursing facility or between a primary care provider and a specialist) tended to have fewer hospital admissions.
Use team-based care. Demonstrations that provided close collaboration between care managers and physicians -- especially those with larger teams that included pharmacists, who could help patients manage their medications-- appeared to have fewer hospital admissions.
Target interventions toward high-risk enrollees. Programs that targeted interventions to beneficiaries they identified as being at greatest risk of being hospitalized—on the basis of medical condition, prior hospitalization, or predictive modeling—appeared to have fewer hospital admissions.
Limit the costs of intervention. To achieve federal budgetary savings, a program’s fees or bonuses must be smaller than its reductions in regular Medicare expenditures. There was nearly a threefold difference in the Medicare fees paid to different organizations that combined telephone and in-person contact to coordinate care, an indication that some organizations were able to deliver such interventions much more efficiently than others.
The complete CBO brief can be found here.
Bella Santorum, Amelia Rivera and ‘marginal’ children who prove no child is marginal
Republican presidential candidate Rick Santorum with his wife Karen. (Matt Rourke - AP) GOP presidential candidate Rick Santorum’s youngest daughter, Isabella, is recovering at Children’s Hospital of Philadelphia after a bout of pneumonia forced her family to rush her to the hospital this weekend and her father to temporarily abandon the campaign trail.
Known as “Bella,” the 3-year-old was born with the genetic disorder Trisomy 18, which is often fatal for infants and leads to physical deformities and cognitive deficiencies.
In a strange coincidence, Bella is being treated at the same hospital that earlier this month made the news for its treatment toward another 3-year-old girl, Amelia (Mia) Rivera, who has the genetic disorder Wolf-Hirschhorn syndrome.
Rivera’s family said Children’s Hospital of Philadelphia officials told them their daughter was not eligible for a life-saving kidney transplant because she was “mentally retarded.” (I wrote about her story in a previous post here.)
Hospital officials will not comment directly on the case, but have said they do not have a policy of denying transplants to children with developmental delays. (Studies have shown such policies are a common, if unspoken and unethical, practice at many transplant centers.)
Hospital officials and the transplant team have also agreed to meet with Mia’s family.
Besides their conditions, ages and the venue in which they are being treated, the little girls share something else: Their stories have touched a public nerve.
In Bella’s case, her story was already well-known. Santorum has said that after she was born, doctors told him and his wife that they should let the girl die because she would never live a normal life. Controversially, he has linked that experience to his criticism of the Democrat-backed healthcare reform.
Santorum critics point out that healthcare reform expands coverage and will, in fact, help families in similar situations.
For Mia, her family’s fight to make her eligible for a transplant has brought her fame. Her plight has prompted tens of thousands to protest both her treatment and also the broader issue of discrimination in medical care.
Politics aside, if that’s possible, what’s most amazing about both these stories and all their similarities is that these two little girls, Bella and Mia, who have both been deemed marginal throughout their lives, are now part of the public discourse.
They are reminding us that children come in all shapes, sizes and forms. That even soft voices have merit. That children cannot be ranked for worth. Marginal? Not them.
The only problem with this beautiful essay is that under health care reform there are people who think that the plight of such children cause, well, a misallocation of resources. In otherwords, why waste money on screening these kids, especially when they drive up health care costs.
Such is the attitude of Jean Slutsky, who is a senior offical at the Agency for Healthcare Quality and Research (AHRQ) and is on the PCORI methodology committee, which will determine how PCORI should conduct CER and what it should measure. Slutksy, like other methodology committee members believe CER should be used to control health care costs. (I will post on these other members in the future.) Here's Slutsky opining on kids like Bella Santorum:
"Compelling stories of children who died from very rare metabolic disorders that might have been detected with newer, more expensive equipment have created powerful momentum for expanded screening of newborns. But in an era of constrained budgets, state policymakers need to weigh the benefits and costs of new screening programs against those of other equally important programs. Nonetheless, it remains politically risky to frame a health policy decision as being based primarily on cost or cost-effectiveness."
http://content.healthaffairs.org/content/24/1/102.full
Maybe it's politically risky because, as Slutsky's statement indicates, such decisions seem to focus on children with rare diseases who would be cheaper to care for if they weren't screened. Sadly Slutsky's view about rationing care based on cost is shared among PCORI methodology mavens.
And taxpayers pay for her salary? Slutsky should resign from PCORI and AHRQ.
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.
