The medical device
industry unleashes two hired women wordsmiths. Consumers Union is independent
of conflict-of-interest.
Read this carefully .
. . it defends the status quo and ignores responsibility for industry
entitlements (carefully crafted by the industry with the help of Congressional
lobbyists) that conflict with patient safety and place the cost burden of
device failure on taxpayers and harmed patients. –FiDA blogger!
MD+DI Editor Says
Consumer Reports Article on Dangerous Devices is Dangerous Reporting
April 4, 2012
--Identifying what the
Consumer's Union gets wrong about the medical device industry and its
regulatory processes. --By: Heather Thompson, Editor-in-Chief, MD+DI
LOS ANGELES, April 4,
2012 /PRNewswire via COMTEX/ -- These days it might feel as if defending the
medical device industry and the 510(k) system is a losing battle. Consumer
Reports released its scathing analysis of the medical device regulatory state
last week. And it is sure to get consumers' attention.
But while the
device industry is in the spotlight, now is a good time to remind people that
the device industry has long understood that the regulatory framework--particularly
510(k) or substantial equivalence--is broken. In fact, the medical device
industry has been leading the charge to fix the process.
It is unfortunate that in
its quest to make the medical device system understandable to a layperson,
Consumer Reports misrepresented some key details in the regulatory process,
thereby causing additional confusion and creating a dangerous precedent in
media coverage of the medical device industry.
Lies and Statistics
The Consumers Union is
not correct in its representation of the industry, claiming, "most medical
implants have never been tested for safety." This is blatantly untrue. The
truth is that devices are tested extensively for safety and effectiveness.
"The [Consumers
Union] is completely discounting any testing other than clinical trials,"
says Floyd Larson, president of PaxMed. "You wouldn't believe the amount
of testing that is done on devices," he says. Larson explains that much of
the effort that goes into developing testing for medical devices is done on a pro-bono
basis. "Clinicians, regulators, and industry members make a significant
effort to develop tests that are as close to clinical trials as possible."
The report also
mischaracterizes the process of the 510(k), saying that "For most implants
and other high-risk devices brought to market, manufacturers do nothing more
than file some paperwork and pay the Food and Drug Administration a user fee of
roughly $4,000 to start selling a product that can rack up many millions of
dollars in revenue."
In this statement, the
Consumers Union is guilty of oversimplification and overgeneralization.
"I'd estimate that 99% of all high-risk devices have randomized clinical
trials, and are done with good science under the auspices of FDA," says
John DeLucia, vice president, regulatory affairs and quality assurance for
iCAD.
A 2010 report led by
Stanford University researcher Josh Makower, and sponsored by the Medical
Device Manufacturers Association (MDMA) estimated that putting a medical device
through the 510(k) process could cost a manufacturer up to $24 million. That
figure factors in bench and functional testing, human factors, environmental
engineering, biocompatibility testing, sterilization validations, documentation
systems, equipment and product validations, as well as many other basic safety
and efficacy tests--all of which are required by FDA to prove good
manufacturing practices (GMPs).
It is telling that the
people interviewed by the Consumers Union have been notably critical of the
medical device industry, and that the report did not include any experts from
FDA or from the industry. Larry Pilot, an attorney and former FDA official with
more than 30 years in the industry, explains that such reporting is dangerous.
"When Consumer Reports publishes this type article presenting a very
negative image of the device industry, large numbers of readers will be
influenced and then will influence others. Those who have been identified as
'experts' in the article have been persistent critics of the industry and not
credible to those who do have a balanced understanding of fact and law."
I posit that the Consumer
Reports article has let its subscribers and the media covering the story down
by not providing objectivity to its analysis. But instead of worrying about how
Consumer Reports has misrepresented the medical device industry (doing so is
surely a losing proposition, anyway). I thought it might be more useful to
tackle the report's recommendations for change, and present some better
alternatives.
CR Recommendation 1: Require
that implants and other "life-sustaining" devices be tested at least
as rigorously as drugs.
To demand pharma-like
testing shows a distinct misunderstanding of the nature of devices. John
Brennan of Eucomed explains the difficulty of testing devices like drugs.
"When it comes to requiring the same type of clinical data for devices as
for drugs, it is worth highlighting that for pharmaceuticals randomized control
trials are relatively straight-forward to perform, and efficacy and relative
safety can be statistically demonstrated in support of obtaining a marketing
authorization provided that the clinical trials are sufficiently powered
(depends on the number of patients)," he says.
For medical devices,
Brennan explains, randomized clinical trials are difficult to perform:
"you can't implant a placebo hip," he says. Further, "clinical
trials cannot be blind or randomized due to strong ethical and practical
issues," he says. A device's effect depends on too many other factors:
clinician training and experience, patient selection, and care delivery
settings, which can vary by region, hospital, and country. "We therefore
believe that 'real world' data from observational studies performed under
routine conditions are equally important (structured postmarket surveillance)."
CR Recommendation 2: End
the practice of "grandfathering" high-risk new implants and
life-sustaining devices.
This is another misnomer.
By "grandfathering," Consumer Reports is referring to substantial
equivalence. But substantial equivalence is not exactly the same as
grandfathering. The term "grandfathering" only applies if no
improvements or changes are made. But such a state is in direct opposition to
the intention and practice of the law. "The prospective intent of the Medical
Device Amendments of 1976 anticipated that devices would be modified and
improved. FDA/CDRH are responsible for determining when the nature of the
modifications or intended use and compliance with the regulatory controls is
not sufficient to provide reasonable assurance of safety and effectives,"
says Larry Pilot.
Therefore industry and
FDA have already responded to Consumer Reports demand that FDA "end the
practice of grandfathering." Any devices "grandfathered" more
than 30 years ago have certainly been subject to significant improvements if
the underlying technology had any healthcare benefit--and they have undergone
rigorous testing to prove safety and efficacy.
CR Recommendation 3:
Create a "unique identifier system," or IDs for implants, so that
patients can be quickly notified about recalls and safety problems.
As Karen Conway, at GHX
can tell you, such a system is already in the works and will be in practice
likely within the next 2 years. FDA has indicated that it will issue its
proposed rule for a unique device identification (UDI) system for medical
devices. "It's with the Office of Budget and Management right now,"
says Conway. She also points to Senate bill, S.2193. Senator Chuck Grassley
(R-IW) introduced the bill this month to require that the Office of Management
and Budget finalize a UDI rule by the end of 2012. "The sooner this system
is in place, the better for patients who have received medical devices,"
Grassley said in a Q&A on his home page.
Conway explains that once
the OMB finalizes the plan, it will be about 18 months before the rule can take
effect. She also explains that the plan would roll out so that the most
risk-averse devices would see adoption first. "Class III, which is mostly
implants, would be first, followed by Class II and Class I products."
CR Recommendation 4:
Create national registries so that problems can be spotted quickly and patients
notified.
In the Consumer Reports
article, Diana Zuckerman compares medical devices to a coffeemaker or toaster
oven, saying these appliances have serial numbers "so if a problem is
found, the company can contact you to warn you. Your artificial hip or heart
valve doesn't."
Wrong. All implants have
serial numbers. "We know exactly what patient had what implant.
Traceability is the first order of business," says DeLucia.
Conway also points out
that a national registry might be unnecessary if the UDI system is harmonized.
A UDI system that is owned and maintained by FDA is key, she says. But far
better than a national registry is a device identification system that is
global. FDA has worked to harmonize UDI in Europe, North America, Asia using
the Global Harmonization Task Force (GHTF) and the Asian Harmonization Working
Party (AHWP). "Such a system would make it easier for global manufacturers
to comply," she says. Further, "if you can assign global UDIs that
would work for registries around the world, however they define themselves
(Swedish, Swiss, Kaiser Permanente, or Joint Replacement, for example),
theoretically you could just take that information from different registries
and compare them," Conway says. That is, the need for a national registry
would be a moot point.
CR Recommendation 5:
Increase the user fees paid by manufacturers for regulatory review so that the
FDA has enough money to do its job.
More user fees won't
necessarily fix the regulatory system. Like most problems, you can't just throw
money at it and expect the problem to go away. For Consumer Reports to say user
fees would fix a problem again indicates an extreme misunderstanding of the
processes involved. "User fees are not going to improve a process,"
says John DeLucia. From his perspective, "the only benefit of increasing
money is that it might help products get to market faster, but [user fees]
wouldn't necessarily make [devices] any safer."
Floyd Larson explains
trends his company has observed: "We have had recent experiences that show
us that, as FDA has more money and hires new reviewers, often the quality of
the reviews goes down dramatically," says Larson. New reviewers with lots
of scientific knowledge ask many questions that are 'nice-to-know'
scientifically, but might not be relevant to the clearance decision."
Larson says he isn't
trying to tell reviewers that don't know they're business. But, "it takes
time to understand what medical device safety and effectiveness is about--user
fees can't fix that."
Roll Back the Rhetoric
Are there improvements to
be made to medical device regulatory systems? Absolutely, which is why FDA,
industry, and a host of experts have been working to do so for the better part
of a decade. Nora Iluri, founder of Clarimed says, "When quality is an
issue, you shouldn't focus on increasing the hurdles for innovation. You should
encourage innovation by making it easier to understand what the quality issues
are and promote the development of new solutions to solve them. This can be
achieved through improved transparency and processes to better understand what
is working and what is not--both pre- and postmarket."
As DeLucia says,
criticizing FDA and the medical device industry is an old story. "This is
an easy target and the report looks at three examples that are fairly well
understood by FDA," he says.
The bottom line is that
we don't need more rhetorical excesses on public health policy. We do need
clear, balanced arguments, solutions to problems, and language that isn't
intended to cause panic.
About Heather Thompson
Heather Thompson is
Editor-in-Chief for MD+DI, and has more than 10 years in the publishing
industry, covering FDA-regulated technologies. She joined MD+DI in 2004.
Thompson holds a BA in English from University of California, Irvine. Her areas
of research include emerging medical technologies, regulatory analysis, and
policy.
About MD+DI
For more than 30 years,
Medical Device and Diagnostic Industry (MD+DI) has served the industry as the
leading source of in-depth news, information and business intelligence. MD+DI's
content team offers authoritative perspectives and provides valuable reference
on the full range of device industry issues. In addition to peer-reviewed
articles by leading experts on specific technology issues, broader features
offer overviews of key business, industry, and regulatory topics.
About UBM Canon
UBM Canon, the leading
B2B media company dedicated exclusively to the global $3.0 trillion advanced
manufacturing sector, helps support the flow of information, commerce and
innovation in such sophisticated segments as medical devices and pharmaceutical
development. UBM Canon also addresses cutting-edge developments in broader areas
of advanced engineering design and manufacturing, and manufacturing processes
and packaging. UBM Canon is part of UBM plc (UBM.L) a global provider of media
and information services for professional B2B communities and markets.
Published on FierceMedicalDevices (http://www.fiercemedicaldevices.com)
Article questions Consumer
Reports analysis of device registration process
April
4, 2012 | By Liz Jones Hollis
Consumer Reports has long been a trusted source people turn to when they want to find
the best washers and mattresses (among a host of other products). But it has
recently taken aim at the FDA 510(k) clearance process, maintaining that
many devices are not tested for safety before they go on the market.
But at least one device expert is taking with issue with this claim,
labeling the magazine's reporting as "dangerous" and not quite
correct in its summation of the device regulatory process.
"It is unfortunate that in its quest to make the medical device
system understandable to a layperson, Consumer Reports misrepresented
some key details in the regulatory process, thereby causing additional
confusion and creating a dangerous precedent in media coverage of the medical
device industry," writes Heather Thompson, editor-in-chief at Medical
Device and Diagnostic Industry.
Floyd Larson, president of PaxMed, agrees, and particularly questions
its contentions about the testing of devices. Consumers Union, the publisher of
Consumer Reports, didn't take other testing outside clinical trials into
account, he maintains. "You wouldn't believe the amount of testing that is
done on devices," he explains, adding that much of it is done on a
pro-bono basis.
Thompson also takes issue with the Consumer Reports' assertion
that manufacturers only pay a user fee of roughly $4,000 and file some
paperwork before their products come to market. She points to a 2010 report led
by Stanford University researcher Josh Makower and sponsored by the Medical
Device Manufacturers Association that put the cost of getting a device through
the 510(k) process at about $24 million.
So, what does she make of the magazine's attempts at making suggestions
for improving the device clearance system? She maintains they are flawed, too.
For example, the magazine asked that it be required that implants and other
life-sustaining devices be tested at least as rigorously as drugs. Well,
there's a problem with that idea, as Eucomed's John Brennan points out.
"When it comes to requiring the same type of clinical data for devices as
for drugs, it is worth highlighting that for pharmaceuticals randomized control
trials are relatively straight-forward to perform, and efficacy and relative
safety can be statistically demonstrated in support of obtaining a marketing
authorization provided that the clinical trials are sufficiently powered
(depends on the number of patients)," he says. Furthermore, "you
can't implant a placebo hip," as he sagely points out.
Thompson has other issues with Consumer Reports' plan. (Throwing
more money at the system to "improve" it won't help the system, for
example.) Whether the authors of the Consumer Reports article are paying
attention remains to be seen, but Thompson raises some excellent points that
readers of the magazine should be made aware of.
- see Thompson's take
Related Article:
Consumer Reports
blasts implant safety
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