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 Robert Califf. Show all posts
Showing posts with label Robert Califf. 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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Tuesday, June 7, 2016

#Cinderblocks3 presentation: 20 slides, 20 seconds each on PREVENTABLE harm from implanted medical devices

NO AUDIO, the slides advance automatically.   FiDA highlight

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Thursday, January 14, 2016

Obama is a fox: Califf is the wolf. FDA headed to obsolescence?


Will Commissioner Califf Lead the FDA to Obsolescence? The Answer is Likely Yes.
by Marcie Jacobs                 December 2, 2015         FiDA highlight
The more I think of Obama and his ways, the more I think he is playing chess. He certainly was playing chess with the ACA by pitting large employers and employees (169 million strong) and insurance companies and policyholders against big medicine and now this with the FDA. He knows the FDA runs counter to his mission so what does he do? He appoints a wolf to guard the henhouse. Why? It doesn't make sense unless he is trying to wake us up to smell the coffee. Any other way he dealt with the corrupt FDA would land him in hot water with his contributors and it wouldn't solve the problem. Most doctors come from the same cesspool as Califf and are practicing allopathic medicine because they can't break free from it. It was too profitable for them pre-ACA and now they believe they are trapped.  In addition, anyone he appointed would eventually do the same as our good ole boy Deputy Commissioner Califf.
From a post by Johanna Ryan, The Ghost of Research Future

"Two facts about Robert Califf are beyond question. He is an expert on clinical trials, who is already seen as a leading architect of the future of medical research. And as the New York Times put it, he has “deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory”. A lot of senior figures in medicine support Califf in spite of his ties to Pharma. The guy is just so bright, and understands the nuts and bolts of drug research so well! Surely a person like this is more useful than some outsider who offers only a squeaky-clean resume, they argue."

For the sake of argument assume that he does become "The Ghost of Research Future" Ghost is a good word to describe an agency that has already lost its reputation and is about to lose all credibility in the eyes of consumers.  Like medicine, research in this country is being transformed and technology and big data are leading the way. In the future, the management of illnesses will be based on our unique genetic makeup.  Clinical trials will no longer be necessary; they are population-based research; the future of research is individual-based and unique for all of us.  And consumers will demand studies and treatment based on their genome. And they will prevent, treat and maintain their disease based on their own unique biological makeup, not something dictated by corrupt agencies within the government that operate at the benefit of big medicine and big pharma and not for the benefit of patients/consumers. 

Consumers in the new healthcare paradigm will become increasingly hostile towards FDA approvals. If it has the seal of approval from the FDA it has the seal of disapproval from consumers. Consumers will use FDA corruption against them.  Extra, extra read all about it, FDA approves the next new blockbuster drug and no one buys it. Company's revenue drops by double digits.  

So what does Obama accomplish by appointing a wolf? He wakes up the American people on both sides of the aisle and he shows us that the FDA is an organization that can't be trusted. And that lesson is invaluable if you want to stay alive in the 21st century.  It puts the ball in our court. We the People are the ones that will chop down the greed, not the corrupt politicians or the pharma-run cronies at the FDA. It is a brilliant move, force the American people into the battle and soon they will dismiss anything that comes out of the FDA and in doing so they will protect themselves and their families.

In the 21st century, it's all about the individual and their genetics so population-based research (Califf's baby) is out and the FDA is one step closer to obsolescence.  The FDA can control providers, inventors, and corporations, but they cannot control the consumer.  That is why it is up to us to control the market and medical drugs and products as well as what we eat by taking our health care dollars elsewhere no matter who pays.  



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Friday, December 18, 2015

MedShadow: Questions for Robert Califf, MD

Questions for FDA Commissioner Nominee


By Suzanne B. Robotti  @Med_Shadow   www.MedShadow.org  MedShadow Foundation
http://bit.ly/1lWDfwz
Published: November 24, 2015  FiDA highlight


Many people have questioned whether cardiologist Robert Califf, MD, has the ability to maintain (or rebuild, depending on one’s point of view) the wall between the FDA drug approval process and inappropriate intervention from pharmaceutical companies if he is selected to be the next Commissioner of the governmental agency. Dr. Califf has worked closely with most pharma companies and the very fact that those companies aren’t opposing his nomination encourages speculation that the FDA will slip even further into closer alignment with pharma’s goals.
Questions regarding Dr. Califf’s ties to the pharmaceutical industry are important and need to be fully explored. However, independence is only one worthwhile question for him. I have many more for Dr. Califf or any FDA Commissioner nominee:
1
What will you do about the 2.3 million people who are rushed to the ER each year due to side effects of drugs prescribed to them? Or those 117,752 deaths due to adverse drug events in 2013? That’s nearly 4x as many fatalities from guns, 33,380.
2
You state that you want to institute an adverse events reporting system for medical devices, similar to the existing one for drug reporting. Have you ever tried to look up a drug on that system? As a consumer, I have found it to be a nightmare of charts, repetitious and incomplete information. What will you do to improve the FAERS system?
3
Seniors take multiple prescription and OTC meds daily. About 35% take 5 or more prescription medicines. Older adults are 2x as likely as others to arrive at emergency departments for adverse drug events. Do you see a role for the FDA in reducing medication errors that cause adverse events or an agency effort to decrease the incidence of the over-medication of seniors?
4
What will you do about doctors giving drugs never tested on children to children?
5
The US and New Zealand are the only 2 countries that allow prescription drug advertising directly to consumers (DTC). What is your opinion about the benefits vs the risks of DTC drug advertising? Would you consider joining the AMA in calling for an end to this practice?
6
What is the FDA’s responsibility in ensuring that drugs approved for a specific, narrow group of patients do not become broadly prescribed? Example: opioids and the growing death toll from the overuse and addiction of these painkillers.
7
Off-label prescribing has been shown to have a significantly higher rate of adverse events, according to a Canadian study published this month in JAMA. Is there a way to control and lower the amount of off-label prescribing? Do you see a need for this?
8
What about post-approval studies? Why aren’t pharma companies penalized for not getting them done instead of being granted extension after extension? A “common” side effect is one that happens in 1 in 100 users. When a study includes only 100, 250 or 500 people, that side effect, even though common, may not be detected until the medicine has been approved and is in the marketplace. Post-approval studies are the best way to track and inform people about the growing list of known side effects for any drug.
9
Will you demand that all research, even those studies stopped or not published, be submitted for review during the approval process?

Do you have questions? Write the members of the Senate Committee that is making the recommendation regarding the FDA Commissioner nominee to the full Senate. The committee is named HELP. Write soon as the recommendation will head to the full Senate soon.
All the Senators on the HELP (Health, Education, Labor, & Pensions) Committee are listed in the chart below. 

If one of your Senators is on the committee, please send your Senator’s health care staffer a message. Also send emails to the leaders of the HELP Committee: Chairman Lamar Alexander’s (R-TN) staffer and Ranking Member Patty Murray’s (D-WA) staffer.
If neither of your senators are on the HELP Committee, please send emails ONLY to Senator Alexander’s and Senator Murray’s staffers. 

Staff members for the HELP Committee are listed at the end of the link above. NOTE: If the list indicates more than one staffer for your senator, send your letter to all of those staffers.
Thank you to the National Center for Health Research for guidance in writing Senators on the HELP Committee.
US Senate HELP Committee

Fname
Lname
State
Committee Assignment
StaffFname
Email Address
Lisa
Murkowski
AK
HELP
Garret
garrett_boyle@murkowski.senate.gov
Christopher
Murphy
CT
HELP
Joe
Joe_dunn@murphy.senate.gov
Mark
Kirk
IL
HELP
Mark
mark_stewart@kirk.senate.gov
Rand
Paul
KY
HELP
Natalie
natalie_burkhalter@paul.senate.gov
Elizabeth
Warren
MA
HELP
Remy
Remy_brim@warren.senate.gov
Barbara A.
Mikulski
MD
HELP
Jessica
Jessica_McNiece@appro.senate.gov
Barbara A.
Mikulski
MD
HELP
Amanda
amanda_shelton@mikulski.senate.gov
Al
Franken
MN
HELP
Erica
Erica_Cischke@franken.senate.gov
Bernard
Sanders
VT
HELP
Sophie
Sophie_kasimow@help.senate.gov
Tammy
Baldwin
WI
HELP
Kathleen
Kathleen_laird@baldwin.senate.gov
Bill
Cassidy
LA
HELP
Robb
robb_walton@cassidy.senate.gov
Bill
Cassidy
LA
HELP
Brenda
brenda_destro@cassidy.senate.gov
Sheldon
Whitehouse
RI
HELP
Jennifer
Jennifer_deangelis@whitehouse.senate.gov
Sheldon
Whitehouse
RI
HELP
Anna
anna_esten@whitehouse.senate.gov
Susan M.
Collins
ME
HELP
Betsy
Betsy_mcdonnell@collins.senate.gov
Susan M.
Collins
ME
HELP
Olivia
olivia_kurtz@collins.senate.gov
Susan M.
Collins
ME
HELP
Amanda
amanda_lincoln@aging.senate.gov
Lamar
Alexander
TN
HELP, Chair
Grace
grace_stuntz@help.senate.gov
Michael F.
Bennet
CO
HELP
Rina
rina_shah@bennet.senate.gov
Johnny
Isakson
GA
HELP
Jordan
jordan_bartolomeo@isakson.senate.gov
Johnny
Isakson
GA
HELP
William
william_dent@isakson.senate.gov
Pat
Roberts
KS
HELP
Emily
emily_mueller@roberts.senate.gov
Richard
Burr
NC
HELP
Natasha
natasha_hickman@burr.senate.gov
Robert P.
Casey
PA
HELP
Sarah
sara_mabry@casey.senate.gov
Tim
Scott
SC
HELP
Chuck
charles_cogar@scott.senate.gov
Michael B.
Enzi
WY
HELP
Tara
tara_shaw@enzi.senate.gov
Orrin G.
Hatch
UT
HELP
Jay
jay_khosla@hatch.senate.gov
Patty
Murray
WA
HELP, Rank Member
Melanie
Melanie_Rainer@help.senate.gov
Patty
Murray
WA
HELP, Ranking Member
Wade
wade_ackerman@help.senate.gov
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