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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Twitter: @JjrkCh
Showing posts with label AdvaMed. Show all posts
Showing posts with label AdvaMed. 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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Saturday, March 15, 2014

Consumers Union communicates to AAOS: 50,000 patients want hip/knee warranty


 Activists Take Fight to Obtain Hip,Knee Product Warranties to AAOS. Will They Succeed?

Posted in Orthopedics by Arundhati Parmar on March 12, 2014
FiDA highlight

At AAOS, Consumers Union, through its Safe Patient Project, is asking surgeons to support their demand to obtain hip, knee warranties from device makers when implants fail early. 
A consumer advocacy group has seized upon the fairly mundane concept of product warranties to turn the heat on medical device makers.
Consumers Union, the lobbying and advocacy arm of Consumer Reports, sent letters to six top hip and knee makers last September asking them to provide product warranties for early implant failures. The letter quoted the American Academy of Orthopaedic Surgeons in saying that 10% of implants fail.
The group has now made a big push in publicizing its message by organizing a campaign outside the annual meeting of the American Academy of Orthopaedic Surgeons, which kicked off Tuesday and ends on Saturday, March 15.
Activists were handing out flyers outside the Morial Convention Center in New Orleans that urged orthopedic surgeons to text their support for manufacturer warranties. Here's what the flyer looked like:


























In an interview at AAOS Wednesday, Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said that only Smith & Nephew formally responded to the letter sent to orthopedic manufacturers in September. Two others acknowledged receving the letter via email but never actually responded to the request. The others did not respond. McGiffert couldn't recall which two companies sent the acknowledgment.
What the group is asking for is not unprecedented in the medical device world, she said.
"Biomet provides a warranty for a partial knee and cardiac products have warranties," she said.
After receiving Consumers Union's letter, Smith & Nephew responded that it is a "complicated issue" because hips and knees can fail for a number of reasons, McGiffert said. It could be the caused by the patient, the surgical technique or the device, McGiffert recalled the company as saying in its response.
But McGiffert clarified that the group is focused on "when the products are the problem." In other words, Consumers Union is not looking for a blanket product warranty, but wants device makers to take responsibility and stand behind the products when device-related problems cause the joint replacement to fail.
"You get warranties for flashlights, toasters and cars, for almost everything in the U.S.," she declared. "I know they are less complicated, but this is something that is going inside people's bodies. We think they ought to stand behind their products for a certain number of years. They can decide how long."
The purpose to bring the campaign to AAOS is to win support from surgeons and get feedback from them, McGiffert said.
However, Consumers Union may not win too much sympathy from the top brass at AAOS.
In a phone interview Wednesday, outgoing AAOS president Dr. Joshua Jacobs said that the "vast majority of orthopedic implants for joint replacement perform exceedingly well - 90% of total joint replacements work 10, 15 years and beyond."
Jacobs did acknowledge that "sometimes implants fail early, " but argued that "while warranties seem like a good idea on the face of it, the issue is more complex." 
Echoing McGiffert's portrayal of Smith & Nephew's response, Jacobs said that early failures could be caused by patients, due to the manner the surgeon did the procedure or it could be because of device problems. But sometimes "a complex interaction of the three" can also lead to early implant failure. So it may not be as easy to tease out which of the three factors caused the implant to fail.
And then there is the potential for infection, which is out of everyone's control, that can contribute to a failure.
"That cannot be addressed with a warranty," Jacobs declared. 
Overactive or obese patients can also lead to implant failure, Jacobs noted. 
However, another well-known orthopedic surgeon and healthcare social media maven, Howard Luks, disagreed with that assesment. 
"I don't think it's fair to blame the patient," he contended. "Once the joint replacement is done, it's stable, it's done. They should  be ready to go. If the patient is obese, then why did you put it in? Device makers understand who these implants are going into and the implants should meet those needs. Or there should be a big red sticker on that says 'Do not put in a patient with a BMI over 30.' So I think the patients have a right to ask for a guaranty or a warranty on a product that is going in their body."
Luks said that unless surgeons push the issue, device makers wouldn't move to provide such warranties.
And it certainly appeared that way. In an interview with DePuy Synthes Joint Reconstruction at AAOS, executives punted the question of warranties to the company's spokeswoman Mindy Tinsley, who responded like this:
"We understand the position that Consumers Union has taken. We are interested in continuing to have a dialogue about this. But I think with joint replacements, it's a complex interaction of factors and revisions have sometimes to do with the implant, sometimes with the patients, sometimes with the technique. We acknowledged the letter but we haven't taken a position. This is an issue we are continuing to explore."
Stryker declined comment via email. A Zimmer spokesman at AAOS said that "it's a complex issue and has a lot of factors surrounding it." The spokesman, James Gill, also forwarded a statement from AdvaMed, the device industry association, which argued that warranties for hip and knee implants that involve complex procedures and involving many different players, involving the patient and the hospital, may not be appropriate. However, it left the decision to provide warranties to individual manufacturers.
Meanwhile, McGiffert said that Consumers Union has secured the support of 50,000 patients who have sent emails to the top orthopedics device makers asking for product warranties-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com
Great Reporting
Submitted by falascoj on March 14, 2014 - 9:32am.
Great graphics and story. I believe you have only hit the surface on this story. Hopefully we will see followup stories on you asking the medical device companies to come clean on why they are fighting the idea of warranty. They are the only major industry or activity that operates that way. The arguments that Mr.Gill has mentioned and the ortho surgeon are lame and I can just see an automotive guy saying --- well be can't do bumper to bumper because an F-150 is different then a Mustang. -Not
I've forwarded this article to numerous groups as an example of a publication actually getting out in front of the biggest deception on the American public since the Warren Commission.

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Friday, October 25, 2013

Toxic medical device cartel penetrates government at the highest levels.



 May 13, 2013 by Brian Johnson
J.C. Scott, SVP, government affairs for AdvaMed is named one of the top lobbyists in theBeltway by CEO Update, a publication covering trade councils

AdvaMed's government affairs guru J.C. Scott has been named a "top lobbyist" by CEO Update, a publication that covers the trade association industry.
Scott received praised by the publication for his work on efforts to repeal the medical device tax,. He was one of only two healthcare related lobbyists on the list.
"[Scott] built bipartisan support for repealing the medical device tax, resulting in a nonbinding 79-20 Senate vote,"the publication wrote. "Helped lead Hill efforts to reauthorize user fees, and then to allow FDA to spend the full amount collected."
AdvaMed hired Scott away from the American Council of Life Insurers 2 years ago. He is a Capitol Hill veteran, having cut his teeth on the Hill as deputy director for policy at the House Republican Conference and in a number of capacities for Rep. Deborah Pryce (R-Ohio) before spending seven years at ACLI.
His predecessor, Brett Loper, left Advamed in early 2011 to become the policy director for House Speaker John Boehner (R-Ohio).
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