Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Showing posts with label MDIC. Show all posts
Showing posts with label MDIC. Show all posts

Friday, July 21, 2017

FDA and Pharma/Device Industry: Where is the Integrity? The BMJ Inquires!


Published 18 July 2017 (FiDA highlight)

  • Jeanne Lenzer, associate editor, The BMJ, USA
A little known private foundation to support FDA’s “regulatory science” takes money out of the FDA’s coffers to support analyses using levels of evidence recommended by industry; many of the foundation’s directors have financial links to the drug and device makers that the FDA regulates. 
Big data can be used cautiously to examine real world outcomes and to improve surveillance of drug safety. For example, it has been used to identify overuse of some interventions and can show drug and device complications in real world settings rather than idealized controlled trials.12 However, big data are a noisy mess, and analyses by entities with profit motives may identify spurious associations that support fast track approvals and indication creep (broadening the indications for drugs and devices).
The Reagan-Udall Foundation curates real world evidence or “big data” derived from routinely collected health data from insurance claims, electronic health records, voluntary registries, and social media. The US drug and device regulator, the Food and Drug Administration, says that such data can speed up research, “saving time and money” for “therapeutic development, outcomes research [and] safety surveillance.”3
In January, Robert Califf, then FDA commissioner, announced the launch of Innovation in Medical Evidence Development and Surveillance (IMEDS), a foundation project that he said would collect and analyze big data to identify “important safety issues.”4
However, critics of the move say that big data are poor for identifying adverse events and the system may expose patients to overtreatment and associated harms. Financial conflicts of interest, they worry, could influence the way big data are used, including exploitation of the weaknesses inherent in observational data to win FDA approval for new uses of drugs and devices and to exonerate drugs of previously detected harms. There is evidence and precedent to support both concerns (box).
No drug risks identified
IMEDS aggregates data from millions of patients mostly through the FDA’s Sentinel system, which was set up to identify and analyze safety problems.5 Public and private researchers can access these data to search for safety signals and other information.4
But claims data and routinely collected electronic health record data are not structured for research purposes, and researchers report that recognition, collection, reporting, and reproducibility of adverse events are unreliable at best.5678910
In 2015, drug safety experts reviewed various big data projects, including the FDA’s Sentinel. They reported that the projects have “proved largely unable to provide credible evidence of new, unsuspected drug adverse effects” and that six years after Sentinel was launched it “has not yet been the primary data source in identifying a single new drug risk that led to a significant regulatory action such as a drug withdrawal, boxed warning, restriction or contraindication.”11
Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, confirmed in January 2017 that Sentinel has not identified any important safety signals to date. “What it has done,” she emphasized to The BMJ, “is evaluate signals from the spontaneous reporting system (for example, excess bleeding with dabigatran) and shown that it was due to stimulated reporting, not a real increase in bleeding. This type of study would have taken a long time using traditional methods.”
But the analysis cited by Woodcock conflicts with the results of other studies that would be unaffected by “stimulated reporting,” some of which found excess bleeding events with dabigatran compared with warfarin, especially at higher doses. Nor was the finding supported by a later FDA analysis.12
Reagan-Udall Foundation
Congress established the Reagan-Udall Foundation in 2007 in response to a damning report by the Institute of Medicine (IOM), which found that the FDA was seriously underfunded and understaffed, with “serious scientific deficiencies.”13 The institute concluded that “product dangers are not rapidly compared and analyzed” and that performance measures used by the FDA, “such as time to review a new product application,” can create pressures that “lead to unintended consequences, such as worse drug safety.”
The IOM recommended that Congress double its funding of the FDA and increase staffing to reduce workload and time pressures. However, the FDA’s budget rose just 19% in inflation adjusted dollars from 2006 to 2016.14 In addition, Congress stipulated that the FDA must contribute $500 000 to $1 250 000 annually to the newly formed foundation, which also receives industry funding.
The foundation was controversial at the outset15161718: critics warned that allowing a quasi-regulatory agency to receive funding from companies regulated by the FDA poses a threat to its integrity; some called it “little more than a front” for industry.16
Watchdog organizations such as Public Citizen, Science in the Public Interest, Health Care Renewal, and the Union of Concerned Scientists warned that mixing industry interests with a regulatory agency would tend to promote the interests of funders and could weaken protections for the public.
Woodcock told Associated Press in 2007 that although the FDA will suggest various research projects, “as with any foundation, the donors will have the primary say over how the funds are used.”15
Directors’ ties to industry
Mark McClellan, FDA commissioner under the George W Bush administration and the first chair of the Reagan-Udall Foundation’s board, promised that strict conflict of interest rules would protect against bias: the foundation’s bylaws state, “No more than four members of the 14 member board of directors shall be representatives of FDA regulated industries.”19
However, there are currently 13 board members, and nine have or had financial ties to industry at the time of their appointment to the board. For example, many of the members hold or held leadership and top scientific positions at industries regulated by the FDA. These include Mark B McClellan, director at Johnson & Johnson; Pamela G Bailey, former chief executive of AdvaMed, the medical device industry’s trade association, and current chief executive of the Grocery Manufacturers Association; Kay Holcomb, senior vice president for science policy at the trade association BIO (Biotechnology Industry Organization); and Garry Neil, chief scientific officer for the drug company Aevi Genomic Medicine.
Board members file conflict of interest forms with the foundation, but the forms are not available on the foundation’s website, and the posted profiles don’t always reveal members’ financial ties. For example, the profile for Mark B McClellan, who serves as the board’s liaison to IMEDS, mentions his academic ties but not that he is a director at Johnson & Johnson and Renova.
Panel stacking
In addition to the number of board members with current or former financial ties to industry is the problem of “panel stacking,” in which the composition of the body seems likely to predispose it toward a particular outcome.20 Ellen Sigal, the foundation chair, has urged deregulation21 and has praised President Donald Trump’s choice of Scott Gottlieb to head the FDA. Gottlieb has long supported deregulation of the FDA and was paid at least $413 000 from multiple drug and medical device companies, largely for consulting and speaking fees, between 2013 and 2015.22
Another director, Allan Coukell, is also vice chair of the board of the Medical Device Innovation Consortium, a public-private entity that has a goal of “collaborating on regulatory science to make patient access to new medical device technologies faster, safer, and more cost-effective.” Coukell testified in a 2015 FDA hearing that industry funding of the FDA through the Prescription Drug User Fee Act “has been a success” by shortening review times and increasing the agency’s capacity to evaluate new medicines. He called for more investment in “regulatory science” and recommended that this be part of future user fee agreements.23
Panel stacking generally occurs when a panel chair or officer with financial conflicts appoints panelists who are not representative of the scientific community but instead are known to espouse a position favored by industry. Former FDA commissioner Andrew von Eschenbach appointed the Reagan-Udall Foundation’s original board members in 2008, when he also triggered controversy by intervening on behalf of industry regarding FDA scientists’ objections to the collagen meniscus implant Menaflex.2425 After leaving the FDA, von Eschenbach became a director at the drug companies BioTime and Viamet.
Funding the foundation
Between 2009 and 2013 the Reagan-Udall Foundation reported $6 429 028 in revenue. About 22% was from the FDA, 39% from “industry,” and 38% from not-for-profit entities.26 However, the not-for-profit organizations include industry trade associations such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and the PhRMA Foundation, which are wholly or partially funded by industry.
One major not-for-profit contributor, the Bill and Melinda Gates Foundation, has attracted criticism for its investments in the agricultural biotechnology company Monsanto and ties to pharmaceutical companies; its lack of accountability to the public; and for hiring Tadataka “Tachi” Yamada, who was then the head of research and development at GlaxoSmithKline (GSK).27282930 Yamada was one of von Eschenbach’s first appointments to the Reagan-Udall Foundation board, and a US Senate committee investigation concluded in 2007 that, while at GSK, Yamada played a key role in intimidating and silencing the prominent diabetes researcher John Buse, who reported excess cardiovascular events associated with the GSK drug rosiglitazone (Avandia).31
Although the Reagan-Udall Foundation is a public charity, partially funded by taxpayer dollars, June Wasser, its executive director, told The BMJ that the foundation is “an independent non-governmental non-profit [that] does not fall under the jurisdiction or authority of any government agency.” This means it is not subject to US Department of Health and Human Services requirements that users of public data must use the data in the public interest, and that the data must not be used primarily for commercial purposes.32
Nor is access to the data free. Wasser said the cost of IMEDS queries “depends on the size and complexity of the study and typically costs hundreds of thousands of dollars,” a price that will be within the budgets of industry but not feasible for community doctors or independent academics.
Funding IMEDS
The Reagan-Udall Foundation’s IMEDS project was separately funded exclusively by nine drug companies, which jointly contributed $3.2m in 2013, the project’s first year of development before official launch in 2017; from 2014 through 2016, drug companies contributed an additional $7.17m, Wasser told The BMJ via email. As it is a non-profit foundation, manufacturers can write off their contributions as charitable donations.
The IMEDS steering committee has six voting and two non-voting members; the steering committee chair, Marcus D Wilson, is also president of HealthCore, a for-profit corporation that describes itself on its website as a “subsidiary of Anthem, Inc, with a first of a kind, large, integrated database and deep understanding of the complexities and nuances of big data.” HealthCore partners with Pharmaceutical Product Development, a global contract research organization, to “help biopharmaceutical clients demonstrate more quickly and cost-effectively how their products will perform and benefit patients in the real world.”
Wilson indicated that he has no financial interests related to any business regulated by the FDA on his conflict of interest form. However, HealthCore is an IMEDS “data partner,” and as such, IMEDS pays for HealthCore’s services. Wilson’s simultaneous roles as chair of IMEDS and president of HealthCore might seem then to pose a conflict of interest.
Elizabeth Andrews, cochair of the IMEDS steering committee, serves as a consultant to “multiple pharmaceutical companies” through her contract research organization, RTI International, and previously was “vice president of worldwide epidemiology at a large pharmaceutical company.”33 Patrizia Cavazzoni, senior vice president for development operations at Pfizer, has held “leadership positions within the R&D organizations at Eli Lilly and Sanofi.”33 Michael Rosenblatt, who served on the IMEDS steering committee from its inception in 2013 until late last year, was chief medical officer at Merck during his tenure with IMEDS.33
Reagan-Udall has issued statements that it protects against “conflicts of interest and undue influence” by ensuring that “an employee or director does not participate in matters in which such a conflict would or could exist,” and that they will be “transparent” in all matters.
Nonetheless, Wilson declined to answer any questions from The BMJ about the financial relations between HealthCore and IMEDS. For Reagan-Udall, Wasser said that details about payments from the foundation or IMEDS to HealthCore “are confidential under the terms of our contract.”
Despite its status as a public charity, supported in part by taxpayer money, the foundation is not subject to Freedom of Information Act requests. The FDA responded to a freedom of information request from The BMJ, stating that it was “unable to locate any records” in relation to contract information between IMEDS and HealthCore.
Light touch FDA
President Trump and the new FDA commissioner, Gottlieb, have promised to slash regulations for drug and device makers. Gottlieb has asserted that “The FDA’s caution is hazardous to our health” and said that the agency should stop burdening businesses with lengthy, expensive clinical trials that require control arms and clinical outcomes. Instead, he has recommended more use of surrogate endpoints and sometimes dropping control arms.34
Industry support of the 21st Century Cures Act, which allows the use of observational data and case reports to support regulatory decisions, represents a profound shift in FDA policy; now, instead of corporate influence being exerted on an individual product basis, the very nature of “scientific evidence” itself is under siege. Big data analyses promoted by a foundation so deeply enmeshed with industry, and by the industry backed 21st Century Cures Act, seems likely to worsen—not improve—drug safety.
Big data: inadequate and inaccurate
Many randomized controlled trials are too small to pick up relatively rare but serious adverse events, so it might seem logical that “big data” could provide better recognition. However, a recent study found that big data were less likely to yield adverse events than large randomized controlled trials with 4000 or more participants.35 This seems at least partly because of the unstructured nature of routinely collected data.
Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, told The BMJ, “Claims data as a source for truth in science has been shown over and over again to be inadequate and inaccurate. The use of big data for regulatory purposes ignores unmeasured confounders and is no substitute for a well designed randomized controlled trial.”
Safety signals aren’t the only issue at stake: industry is promoting applications of real-world analyses for “precision medicine” and comparative effectiveness research.36 Yet, analyses of observational data often yield spurious associations—a problem that may be increased by orders of magnitude with big data because they allow researchers readily to test multiple hypotheses, increasing the likelihood of finding one or more associations to be “positive” simply because of the play of chance (that is, false positives).37
In a study involving 17 275 patients and 835 deaths that compared treatment effects on mortality using routinely collected data and subsequent randomized controlled trials, the authors reported that “real world data” analyses “showed significantly more favorable mortality benefits by 31% than subsequent trials (summary relative odds ratio 1.31 (95% confidence interval 1.03 to 1.65; I2=0%)).” The difference was apparent even with statistical attempts to reduce confounding bias in each of the observational studies.38
The overly optimistic results of real world data in effectiveness studies may stem from confounding by indication, publication bias, and immortality bias. John Ioannidis, professor of medicine and of health research and policy at the Stanford University School of Medicine and one of the authors of the study, told The BMJ that routinely collected data are more likely to yield “biased results,” and he is “very skeptical about using real world evidence to make licensing or guideline decisions.”
A pertinent example is the “Take 3” flu campaign by the Centers for Disease Control and Prevention, which urged the public to seek treatment with a neuraminidase inhibitor because, according to CDC director, Thomas Frieden, it can “saves lives.”39 The Take 3 campaign was funded by Roche, the manufacturer of the neuraminidase inhibitor oseltamivir. However, in 1999, the FDA had written to Roche telling the company to refrain from claiming the drug “saves lives” since randomized controlled trials had not proved that it reduced mortality or even the incidence of pneumonia. When questioned about his claim, Frieden said the CDC discounted a Cochrane meta-analysis that showed no benefit because Cochrane “limited” to RCTs only; instead, Frieden said observational data and case reports supported his claim that oseltamivir saves lives.394041
Footnotes
  • Provenance and peer review: Commissioned; not externally peer reviewed.
  • Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.
References

http://www.bmj.com/content/358/bmj.j327
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Friday, November 30, 2012

Astroturf Lobby Group? Where is the Patient Engagement?


Greetings,

The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues.  Additional information on the MDIC can be found at http://www.deviceconsortium.org/

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,

Michelle McMurry-Heath
Associate Director for Science, Acting Chief Scientist
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration


---------------------------------------------------------

You are invited to attend the Senate MedTech Caucus briefing:

Monday, December 3rd, 10:30 am – 12:00 pm
Room 106, Dirksen Senate Office Building
Announcing: “Medical Device Innovation Consortium”
Featuring: FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).
The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science.  It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.
The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.
Speakers will include:
Senator Amy Klobuchar
Senator Al Franken
FDA Commissioner, Margaret Hamburg, M.D.
FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.
Immucor, Inc., CEO, William Hawkins
LifeScience Alley CEO, Dale Wahlstrom



http://www.deviceconsortium.org

The Medical Device Innovation Consortium is a public private partnership whose mission is to improve health through the application of shared knowledge in regulatory science.
Focused on the Medical Device Industry
The MDIC is the only public private partnership focused exclusively on the strategic needs of the medical device industry. The MDIC is designed to create a collaborative environment where the private sector can partner with the FDA’s Center for Devices and Radiological Health to solve technical issues that affect the industry.
Focused on Regulatory Science
Regulatory science refers to the development and evaluation of new tools, methods, standards and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.
Focused on Improving Health
The MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the U.S.
Founding Members
FDA
Medtronic
Life Science Alley

About Us
The MDIC is the first ever Public Private Partnership (PPP) created with the sole objective of advancing medical device regulatory science. The intent is to be a national 501c(3) organization that operates in partnership with the FDA.
•                The PPP relationship was formalized with the signing of a Memorandum of Understanding between LifeScience Alley, Inc., a Minnesota trade association, and the FDA on December 7, 2011. In August 2012, Articles of Incorporation were filed to formally establish the MDIC.
•                Membership and participation in the MDIC will be open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.
Governance Structure
The MDIC will be governed by a Board of Directors that will oversee the MDIC’s subcommittees and assist in identifying sources of funding. Subcommittees will represent industry sectors or technology areas (eg. Modeling, interoperability, orthopedics, neurological devices).
•                Each subcommittee will be responsible for establishing working groups chartered with identifying key issues affecting their industry segment.
•                The working groups will bring forward project plans for prioritization and funding allocation.
What We Do
Strategies
The MDIC will pursue several strategies in support of its mission:
1.            Create a forum for collaboration and dialogue, working within a flexible governance structure to encourage broad participation from the different industry stakeholders including FDA.
2.            Make strategic investments in regulatory science, utilizing working groups to identify and prioritize key issues and to request, evaluate, and implement project proposals that support the MDIC’s mission.
3.            Provide tools to drive cost effective innovation, emphasizing education and the development of new methods and approaches with well documented data and details to enable implementation.
Value
The activities and output from the MDIC will:
•                Ensure innovative technology is readily available to U.S. patients
•                Make the medical device regulatory process more expeditious, transparent and effective
•                Reduce the risk and expense of clinical research
•                Reduce the time and cost of medical device development
Projects
The MDIC will accept project proposals specifically focused on advancing medical device regulatory science.
After the initial meeting of the MDIC Board of Directors (early in CY13), the first sector subcommittees will be commissioned.
•                The subcommittees will organize working groups to develop rigorous project plans for prioritized topics.
•                Detailed project plans will be used to solicit project specific funding from companies who will benefit from their outcome and foundations interested in supporting the initiative.
The advantages of conducting research within the MDIC include:
•                Involvement of the FDA at all stages of the work thereby building awareness of and support for specific product development tools and approaches.
•                The ability to share best practices across industry and academia.
•                Exposure to a range of perspectives representing multiple constituents which can ensure more robust project development and data interpretation.
•                A mechanism for sharing the expense of research in the regulatory science, non-competitive domain.
TOP

Join
The core operations of the MDIC are funded through contributions from members.
•                Pricing for annual membership is determined based upon the operating expenses for the MDIC.
•                The goal is to keep the membership low enough to encourage broad, cross-industry participation while still meeting the operational needs of the organization.
•                It is anticipated that as the membership base is increased, there is the potential that the dues per member will decrease.
Membership will be offered at several levels based on organization type and, if applicable, annual revenue. Project specific funding will be obtained from companies and foundations as a result of working group development of rigorous project plans.
•                $150,000 contribution annually: Companies with annual revenue >$10 B
•                $100,000 contribution annually: Companies with annual revenue between $5–10 B
•                $50,000 contribution annually: Companies with annual revenue between $1–4.9 B
•                $10,000 contribution annually: Companies with annual revenue <$1 B
•                $5,000 contribution annually: Nonprofit Sector
Benefits of Membership
The MDIC will provide its members with:
•                A mechanism through which to influence the future of the medical device industry by virtue of direct, collaborative discussions and projects with FDA.
•                A process for identifying, documenting, prioritizing and removing issues affecting the industry.
•                Processes, policies, support staff and pooled project funding to enable efficient regulatory science research in areas of strategic importance to the industry.
•                Educational forums in which to learn about the evolving regulatory science process, new tools, standards and test methods.
•                Searchable databases and links to relevant reports and methods.
•                Regular updates on the status of the MDIC’s activities and opportunities for involvement.
TOP

Contact Us
To receive further information and to discuss next steps and membership details, please contact:
Maura Donovan, Ph.D.
Interim Executive Director, MDIC
763-505-4515
maura.donovan@medtronic.com
or
Dale Wahlstrom
CEO of LifeScience Alley
952-542-3077
dwahlstrom@biobusinessalliance.org
TOP

Press
Minnesota Device-Makers Join Forces with FDA to Advance Regulatory Science
Regulatory Intelligence | Posted: 8 December 2011
Minnesota-based medical device lobbying group, LifeScience Alley, signed a memorandum of understanding with the US Food and Drug Administration (FDA), making official a year-long partnership to continue developing best practices in regulatory science. Center for Devices & Radiological health chief Dr. Jeffrey Shuren signed the memorandum, formalizing more than a year of joint effort toward developing regulatory science — a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. If the pilot version of the program works in Minnesota, it may serve as a national model for device safety and clearance. (Mass Device)
Join the discussion on Regulatory Exchange








http://www.massbio.org/news/181-sen_brown_co-chairs_medical_technology_caucus/news_detail

Sen. Brown co-chairs Medical Technology Caucus
April 4, 2011

WASHINGTON, DC— U.S. Senators Scott Brown (R-MA) and Amy Klobuchar (D-MN) announced today that they will serve as co-chairs for the new Senate Medical Technology Caucus in the 112th Congress. The caucus aims to increase awareness about issues facing the medical technology sector, an industry that creates life-saving and life-enhancing innovations that improve patient care.
“In Massachusetts, we have more than 200 medical device companies and hundreds of bio and pharma companies, all of which provide good-paying jobs to thousands of citizens,” Brown said. “It is critical that we provide a business environment for them to innovate, grow and thrive. I’m pleased to be the Republican chair of this bipartisan caucus, and look forward to working with my colleagues on both sides of the aisle to give our medical device and technology companies the tools and resources they need to continue their important work.”
“These businesses not only spark medical breakthroughs, they save lives,” Klobuchar said. “Every day in every state small medical technology companies are driving the innovation agenda we need to compete in a global economy. I will continue to work to make sure that Minnesota remains a leader in health care innovation by developing innovative products while maintaining patient safety.”

The United States is the world’s only net exporter of medical devices, with a $5.4-billion annual trade surplus. Minnesota is home to 400 medical device practices that support over 50,000 jobs in the state. The industry provides good-paying jobs to more than 400,000 Americans, with total direct and indirect employment exceeding two million.
Klobuchar has led the effort to cut red tape that threatens innovation in this industry. After a December report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar and Brown 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 is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and plans to hold a hearing to examine the medical device approval process and to examine ways to improve export options.
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