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Dr. Jerry Avorn (in his one-sided and self-congratulatory New York Times op-ed) misses a crucial piece of the argument on academic detailing – fairness.
Government detailing programs aren’t neutral. Just like detailing programs run by pharmaceutical companies, there is an inherent "interest."
According to the Agency for Health Research and Quality (AHRQ) the government’s top priority is ‘‘high volume’’ practices across 150 Metropolitan Statistical Areas. So, rather than focusing on offices with disproportionately high negative patient outcomes, the government is directing its efforts against those doctors who are high prescribers—which is a pretty good indicator about what government detailing is all about—decreasing cost rather than improving care.
When AHRQ’s ‘‘outreach experts’’ phone physicians to request appointments, they are allowed to entice physicians with the promise of free Continuing Medical Education (CME) credits. Would a pharmaceutical company be permitted to offer such an enticement? No.
Government-funded detailers must be held to the same high standards as industry representatives. This simple step would ensure providers are receiving accurate, unbiased information on the best treatment options available to improve patient care. When it comes to academic detailing, fairness is the proper yardstick. The general lack of rules or oversight stands in stark contrast to the extreme scrutiny with which industry “detailers” are subject in their interactions with physicians.
In Utah, the recently passed Information on Pharmaceutical Products Act makes the common sense point that without public scrutiny there is no guarantee that government-sponsored detailing will present information that is unbiased, peer-reviewed, and aligned with the existing evidence base. Bravo. Without clear guidelines, there is nothing to prevent government detailers from using their outreach to advocate for lower costs instead of educating for better care.
Per the new Health Affairs study on Consumer Directed Health Plans (CDHPs), here is the article.
As to the study design – there is no discussion of outcomes. As to the reason – is it unfair to say that the benefit model is being pushed for short-term economic benefit to … employers and payers?
Just sayin’.
For more on this, see The Cost/Quality Conundrum.
The study found that members in one large employer’s health plan filled significantly fewer prescriptions following a transition from a preferred-provider organization PPO plan to a consumer-directed health plan. The study followed more than 13,000 individuals for five years.
The article cites a Towers Watson employer survey finding that the percentage of employers offering only CDHPs to employees increased from 5% in 2007 to 8% in 2012 and is expected to rise to 13% in 2013.
Enhanced quality? Better outcomes? No, lower cost.
Regulations pertaining to the tax treatment of health reimbursement arrangements and HSAs as well as ACA’s excise tax on high-cost health plans that takes effect in 2018 “make CDHPs more attractive to employers because they may keep costs below the threshold that triggers the tax.”
Outpatient physician visits showed a significant decline and emergency department (ED) visits showed a significant increase for the study group over the four years following the switch to a CDHP. “When it comes to the initial decline in prescription drug use, this may be the result of fewer outpatient office visits or simply the introduction of the CDHP,” the article says. “However, it is unknown whether people only reduced unnecessary prescriptions or reduced the use of necessary pharmaceutical services. If the latter occurred, it may explain the longer-term increase in ED use.”
“The increase in ED use might stem from the long-term implications of reductions in physician office visits and prescription drug use after the CDHP was implemented. Fewer physician office visits may lead to the writing of fewer prescriptions, which could in turn mean that individuals with chronic conditions are less adherent to recommended medication therapy,” the article says. However, the article adds that more study is needed to determine the cause for the increase in ED visits.
It will be interesting to analyze the paper to see the intricacies of the benefit structure and whether that played a role in the drops in outpatient office visits and RX use and increased ED visits.
The FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees voted 20 of 26 to recommend removing or modifying rosiglitazone's highly restrictive label and distribution system. Five voted to keep the product's risk evaluation and mitigation strategy (REMS) as it is now.
"I find no substantial evidence or information that rosiglitazone is unsafe," Arthur Moss, MD, cardiology professor at the University of Rochester School of Medicine in New York, said, adding its ability to lower blood sugar without causing hypoglycemia proves it could be of use.
Sanjay Kaul, MD, director of cardiovascular fellowship training at Cedars-Sinai Medical Center in Los Angeles, said there's not enough evidence to support or blame rosiglitazone's safety and therefore physicians should be able to choose it if they desire.
Why is this important so far after the fact?
First of all, it’s important because cardiologists need to have faith in the products that they have in their armamentarium.
Second it’s important to set the record/RECORD straight. After the 2010 media circus, the Congressional carnival, and the endless posturing from the Cleveland metropolitan area – yesterday’s adcomm vindicated both the process and the people at the FDA. In 2010 the pressure was withering. In 2013 there was a degree of redemption.
(As Mark Twain quipped, “The rule is perfect: in all matters of opinion our adversaries are insane.”)
Thirdly, the adcomm discussion and vote is important relative to the FDA’s evolving views on the future development and review of diabetes medicines.
Let me embrace thee, sour adversity, for wise men say it is the wisest course.
-- William Shakespeare
A Portland, Maine, physician announced on April 1 that he would cut the middle man and deal directly with his patients, no longer accepting insurance in any form.
"I’ve been able to cut my prices in half because my overhead will be so much less," Dr. Michael Ciampi told the Bangor Daily News. Before, Ciampi charged an existing patient $160 for an office visit addressing one or more complicated health problems. Now, he charges $75.
Ciampi lost a few hundred of his 2,000 patients who had insurance and didn't want to deal with the hassle of paperwork for reimbursement, but he expects to make up the loss by attracting the self-employed, the young and others without insurance or with prohibitively high deductibles.
Read more.
Anna Gorman of the L.A. Times on the drive to enroll young Americans on insurance plans:
Arsine Sargsyan is 23 years old, healthy and uninsured. She chooses to forgo coverage for one simple reason: "I never get sick."
Despite her reluctance, Sargsyan is exactly the type of person insurance plans, states and the federal government are counting on to make health reform work.
As the clock ticks toward the 2014 launch of the Affordable Care Act, health leaders across the nation are embarking on a tough task: persuading young adults like Sargsyan to enroll. Their participation will be critical to balance out older, sicker patients more likely to sign up for health insurance as soon as they are able.
Read more.
Tom Miller of the American Enterprise Institute on the ACA’s health flexible spending account provisions negative impact on older Americans:
The central provisions of the Affordable Care Act require younger and healthier Americans to buy insurance policies that will, in essence, subsidize the healthcare of older and sicker Americans. But one of Obamacare's hidden taxes — a new limit on contributions to health flexible spending accounts, or FSAs — will hit older and chronically ill individuals hardest.
Starting this year, the healthcare law imposes a $2,500 annual cap on an individual's contribution to an FSA that is part of an employer's "cafeteria" benefits plan. Such contributions, diverted directly from one's paycheck, are not subject to federal income and payroll taxes. The money in an FSA can then be used to pay for qualified medical expenses such as deductibles, co-insurance and co-payments, as well as services not covered by insurance.
Read more.
The percent and absolute number of colonoscopies and other procedures performed on colon cancer patients in hospitals has declined. Also, the length of hospital stays and number of in hospital deaths have fallen by 30 percent. Indeed, colon cancer treatment costs in America are growing more slowly than in Europe.
Yet, over the past 30 years, death from colon cancer has declined faster in America than in Europe. Nearly 65 percent of all Americans will live 5 years or longer with colon cancer compared to 59 percent of Europeans.
The difference? Americans get screened and treated faster with newer medicines and diagnostics. The way to saving money and lives is faster innovation, not more regulation.
Yesterday I had the pleasure of participating on the keynote panel at the World Pharma Congress. My fellow panelists were Karim Dabbagh (Executive Director and Head, External R&D and Innovation Research Units, Pfizer Worldwide R&D) and Glen Gaulton (Professor, Pathology and Laboratory Medicine, Executive Vice Dean and Chief Scientific Officer, Perelman School of Medicine, University of Pennsylvania). The panel was expertly chaired by Rick Turner (PGCE Senior Scientific Director, Clinical Communications, Quintiles and Fellow, Society of Behavioral Medicine).
Our topic was, “Advancing Pharma R&D through Communications and Collaboration.” It was an exciting 90 minutes.
The issue of out-sourcing R&D isn’t new – but it’s mighty contentious. And it’s the new reality of drug development. But, if we are to learn any lesson from the CRO experience, it’s that while we say “partnership,” the danger is that it devolves into a vendor-like relationship. It’s the Golden Rule. He who has the gold makes the rules. Will that be acceptable to high-level, big ego Ivy Hall-ers?
And then there’s the issue of academic priorities, specifically tenure. Does industry funding carry the same weight as NIH grants when it comes to advancing a university career? Not at present. That will have to change.
Will university researchers pursue their programs with the same time-driven focus as their pharma counterparts? After all, there aren’t any quarterly analyst calls to worry about. And, as already mentioned, if the funding is viewed as secondary to “tenure-track” funding, how will the work be prioritized?
And then there’s the IP question. According to both Dabbagh and Gaulton, IP negotiations are generally smooth. That’s good news – but there’s a lot of road ahead on the R&D partnership superhighway.
CROs, at least know what needs to be done. Researchers (whether inside a company or a university) don’t. That’s why it’s called research. One issue that arose is the need for total sharing and absolute transparency between industry and academic partners on all levels of the engagement. Is this happening? Sometimes. The good news is that when it does occur – the relationship (and results) are more positive.
But talk with CROs and you’ll hear their frustration over being instructed what to do by their pharma masters. (In most cases their former employers.) Fortunately, that too is changing as the urgency of new and innovative clinical trial protocols and programs becomes self-evident.
Need drives change. Just as CROs are now really partnering with pharma to drive the development of personalized medicine, so too must academic researchers and their industry partners collaborate on the continued evolution of pharmaceutical innovation. It will take discipline and focus. It will be risky. And it will take will. There is a confluence of interest.
To borrow some FDA parlance, will industry/academic partnerships result in expedited pathways in drug development? It must – because if it is only viewed as a cost-saving mechanism it will fail.
“Change is not required. Survival is not mandatory.”
-- W. Edwards Deming
BioCentury reports that the FDA is seeking comments on approaches to make available to non-FDA experts and other interested parties de-identified and masked subject level clinical trial data derived from regulatory applications. According to the notice published in the Federal Register, the agency said the proposal is driven by its "desire to improve the product development process," noting that data may be useful "to address key hurdles in drug development" like validating new trial endpoints or clarifying how products work in different diseases. FDA also noted that pooled data can also be used to identify and analyze safety issues.
FDA is seeking input on strategies to minimize the ability to identify specific products, including making available certain data from a random sample of patients or pooling data for a number of products within a product class. The agency is also seeking input on how to mask data and limitations to making the masked data available, as well as input on de-identifying data. Additionally, FDA is seeking input on situations where disclosing masked data would be the most useful to advance public health. FDA said its proposal does not address making available unmasked safety and efficacy data that can be linked to a specific, identified application, including full study reports. The agency also said it "will not make available business-related confidential commercial information contained in product applications." Comments are due Aug. 3.
By the end of June, EMA is slated to publish a draft policy for public consultation providing more details on its plan to proactively release patient-level clinical data for approved drugs.
The New York Times reports, “Government officials, drug companies and medical experts, faced with outbreaks of antibiotic-resistant “superbugs,” are pushing to speed up the approval of new antibiotics, a move that is raising safety concerns among some critics.”
But the only “critics” the Gray Lady was able to unearth were a former mid-level FDA reviewer and old reliable agency critic Steve Nissen.
Critic #1: “There is really no way of knowing how these drugs are going to perform,” said Dr. John H. Powers, a former F.D.A. antibiotics reviewer who is now an associate professor at George Washington University in Washington.
That is clearly not correct. These “special medical use” products aren’t going direct from bench to bedside – they must still undergo rigorous, FDA-approved development programs -- albeit carefully monitored trunicated ones with robust Phase IV follow-up.
Critic #2: “The big problem is controlling the marketing,” said Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic and a frequent critic of the F.D.A. “Companies can get a drug on the market for a narrow indication and before you know it, it is being used in everybody.”
This is a recording.
Now on to the real issue – a huge and global public health crisis.
“We are facing a huge crisis worldwide not having an antibiotics pipeline,” said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the Food and Drug Administration. “It is bad now, and the infectious disease docs are frantic. But what is worse is the thought of where we will be five to 10 years from now.”
The compete New York Times article can be found here.
Yesterday, Indiana Governor Mike Pence joined Indiana-based global life sciences and research university executives to unveil the Indiana Biosciences Research Institute, the first industry-led collaborative life sciences research institute in the country.
The Indiana Biosciences Research Institute is a statewide public-private partnership advanced by BioCrossroads and led by Indiana’s life sciences industry, with support from the State of Indiana and partnerships with Indiana’s research universities to discover, develop and deliver biosciences innovations in Indiana. The Institute will serve as the centerpiece project of the BioCrossroads public-private collaboration through its attraction of world-class scientific leaders and life sciences research dollars to Indiana, while focusing on human health solutions for improving the lives of Hoosiers and people around the world.
“Indiana has built a life sciences ecosystem unlike any other state and faces a new season of opportunity as a result,” said Governor Pence. “The Institute will strengthen Indiana’s reputation as a global life sciences hub and produce breakthroughs that will attract new investment to our state and create good-paying jobs for Hoosiers.”
The Indiana Biosciences Research Institute is the result of leadership from industry executives from Eli Lilly and Company, Dow AgroSciences, Roche Diagnostics, Cook Medical, Indiana University Health and Biomet and the Governor of Indiana, with active support in initial development by BioCrossroads. Indiana’s research institutions, including Indiana University, Purdue University and the University of Notre Dame also are participating in the development process.
“This Institute comes at a pivotal time in our state’s evolution as a global life sciences leader. With a bioscience sector that now contributes more than $50 billion a year to the Hoosier economy, Indiana is ranked by BIO and Battelle as one of the top five states in the nation in terms of our total number of life sciences companies and employees. Through the Institute, BioCrossroads believes we have found a bold way to raise our game in Indiana by building the platform that will truly take us to the next level of success,” said David Johnson, president and CEO of BioCrossroads, an organization focused on investment, development and advancement of the state’s signature life sciences strengths.
The Indiana Biosciences Research Institute is developing a novel operating model, with industry providing a major source of funding and defining the Institute’s research focus to optimize commercialization opportunities. The Institute also draws on a life sciences industry cluster that is one of the largest and most diverse in the nation, with global companies that are developing next-generation drugs and pharmaceuticals, diagnostics tests, medical devices, cell-based therapies, agricultural biotechnology and animal health and production solutions. This diversity of industry capabilities creates opportunities for Indiana-based life sciences companies to work in collaboration – not competition – toward common scientific discoveries.
“The research institute will change the bio-landscape of our region,” said Bart Peterson, senior vice president at Eli Lilly and Company. “Indiana’s life sciences companies spend billions of dollars in research and development each year to advance health care innovations for improved human health. The Institute will help us nurture our partnerships across the country and develop more intellectual capital here in Indiana – allowing us to keep more research dollars in the state, attract more federal research funds, and draw top scientific minds to feed our research pipeline and local economies.”
“Having the best talent and the best scientific minds is crucial for growing our life sciences industry cluster in Indiana,” said Steve Ferguson, chairman of Cook Group, which is celebrating its 50th anniversary this year. “World-class scientific talent at the industry and academic level is one of the state’s most powerful economic development tools. Just as companies like Lilly and Cook Medical started as small, entrepreneurial operations, we expect the Institute to draw the best and the brightest to Indiana to further deepen our life sciences industry roots and grow more business opportunities.”
As part of the Institute development process, industry leaders have defined common scientific interests for research and discovery. The Institute will initially focus on the most pressing global and local interrelated human health issues: cardiovascular disease, diabetes, obesity and nutrition. These interrelated metabolic disorders are a major economic burden and a leading cause of death in the United States. Risk factors, such as high blood pressure and insulin resistance, allow for early disease detection, and timely preventive actions, such as through improved nutrition, and early intervention can slow or prevent the onset of disease. This is an important scientific discovery subject for the approximately 35 percent of Americans who suffer from cardiovascular disease and metabolic disorders, and is a significant risk for Hoosiers who suffer disproportionally from these diseases.
“We have an opportunity to not only help millions of people around the world who are battling these metabolic disorders, but we can have significant impact on Hoosiers who suffer more than the average American from diabetes and who rank 8th in the nation in terms of obesity,” said Jack Phillips, president and CEO of Roche Diagnostics. “The Indiana Biosciences Research Institute will provide the platform to deliver significant scientific advancements that could improve Hoosier lives.”
“The ability to better understand metabolic disorders impacts the work of nearly every life sciences company in Indiana,” said Antonio Galindez, president and CEO of Dow AgroSciences. “Together, we can develop a deeper understanding of the pathways leading to metabolic disease and apply those discoveries to not only medical interventions, but also to greatly enhanced nutritional sources developed through advanced crop improvement technologies and other advancements in human health.”
“Patients and clinicians have much to gain by the success of this critically important new venture,” said Daniel F. Evans Jr., president and CEO of Indiana University Health. “The discoveries and inventions generated by the Institute will be used by our physicians to care for patients. To accelerate the pace of innovation from lab bench to patient bedside, we are pleased to make our healthcare system available to researchers to test potential new treatments and therapies.”
The estimated $360-million Indiana Biosciences Research Institute is a non-profit entity that is anticipated to be supported largely by corporate and philanthropic funding with oversight from a largely donor-based board of directors representing the life sciences industry, the state of Indiana, academia and nonprofit donors. The State of Indiana has appropriated $25 million for the biennium for start-up costs. An additional $25 million in start-up funding is being sought from industry and philanthropic sources, which will be used in part to recruit a nationally recognized CEO and research fellows. The remaining capital funding will be sought from corporate and philanthropic sources, and ongoing operating costs will be funded through Institute endowment proceeds, industry-sponsored research and federally funded research.
The Indiana Biosciences Research Institute will attract local and national scientific leaders beginning with the CEO and the recruitment of research “Indiana Fellows.” These research fellows will lead teams of scientists and partner with industry and universities on research projects. These teams will consist of experts across a spectrum of competencies, including bioengineering, bioinformatics, nanotechnology and agriculture. These cross-functional teams will share resources and research laboratories at the Indiana Biosciences Research Institute and will work onsite at industry and research university labs with academic and industry scientists.
“As the scientific discovery process increases in complexity, more companies are looking outside their own walls for multi-disciplined team members to help move innovation forward, at a faster rate, in order to remain competitive in an increasingly global marketplace,” said Jon Serbousek, president, Biomet Biologics. “A cross-industry, statewide partnership focused on commercially translatable innovation on the cutting edge of basic and clinical science will help the state’s life sciences industry move to the next level.”
“The Indiana Biosciences Research Institute provides a new and exciting opportunity for our research universities to work with our statewide life sciences industry,” said Bill Stephan, vice president for engagement at Indiana University. “The Institute will bolster our ongoing efforts to recruit highly regarded local and national researchers and graduate students. We envision the dynamic of researchers from the Indiana Biosciences Research Institute working alongside researchers in industry or university labs, strengthening long-term collaborative research and funding opportunities.”
More information about the Indiana Biosciences Research Institute can be found at www.indianabiosciences.org.
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.
