Why I Fight to Improve the FDA, and Why I Fight to Improve the FDA, and You Should TooYou Should Too

Diana Zuckerman, PhD, President Diana Zuckerman, PhD, President National Research Center for Women & FamiliesNational Research Center for Women & Families

Cancer Prevention and Treatment FundCancer Prevention and Treatment Fund

Unsafe Medical Products Unsafe Medical Products in the Newsin the News

Medtronic Agrees to $23.5 Million Settlement in Kickback Case

With Warning, a Hip Device Is Withdrawn

Trial of Synthetic Mesh in Pelvic Surgery Ends Early

Defective Medical DevicesDefective Medical Devices

Hit Prime TimeHit Prime Time

Low Risk DevicesLow Risk Devices

Moderate Risk (510k)Moderate Risk (510k)

95+% are Reviewed as 510(k) 95+% are Reviewed as 510(k)

IOM: No evidence of safety or efficacy IOM: No evidence of safety or efficacy Must be Substantially EquivalentMust be Substantially Equivalent to to

“predicate device or devices” “predicate device or devices”

No clinical trialsNo clinical trials No inspectionsNo inspections No studies are required post-marketNo studies are required post-market Can’t be rescindedCan’t be rescinded

High Risk Medical Devices High Risk Medical Devices (pacemaker, heart, infusion pump)(pacemaker, heart, infusion pump)

Highest Risk Devices: PMAHighest Risk Devices: PMA

Premarket ApprovalPremarket Approval Reasonably SafeReasonably Safe Reasonably EffectiveReasonably Effective

Based on Based on oneone clinical trialclinical trial (not double (not double blind ) with smaller sample than blind ) with smaller sample than required for prescription drug datarequired for prescription drug data

FDA Approval of FDA Approval of Drugs and DevicesDrugs and Devices

Does NOT meanDoes NOT mean

Nobody will die or be harmedNobody will die or be harmed This product is safe for long-term useThis product is safe for long-term use This product is more effective than other This product is more effective than other

products on the marketproducts on the market

510k Substantial Equivalence510k Substantial Equivalence

Similar “intended use”Similar “intended use” Similar material or mechanism of Similar material or mechanism of

actionaction Similar risk: benefit ratioSimilar risk: benefit ratio

=

Are these substantially Are these substantially equivalent?equivalent?

Vitek (teflon) TMJ implants Dow silicone sheet

?

Are these substantially Are these substantially equivalent?equivalent?

=?

GAO ReportGAO Report510(k) Reviews in 2003-2007510(k) Reviews in 2003-2007

FDA Cleared FDA Cleared 90%90% of 13,000+ of 13,000+

medical devices medical devices

More Recalls More Recalls Almost Almost half a billion 510(k) deviceshalf a billion 510(k) devices were were

recalled as recalled as high riskhigh risk in late 2010 and in late 2010 and early 2011, including contaminated early 2011, including contaminated alcohol swabs that killed this 2-year old alcohol swabs that killed this 2-year old boy and then infected others.boy and then infected others.

1

More Recalls More Recalls

GAO’s estimates that GAO’s estimates that 3,000+3,000+ recalls from recalls from 2005 through 2009 were 2005 through 2009 were high-risk or high-risk or moderate-riskmoderate-risk recalls recalls

Divide 3000 by the device industry’s Divide 3000 by the device industry’s estimate of 20,000 device submissions.estimate of 20,000 device submissions.

RESULTS: RESULTS: 15% were recalled!15% were recalled!1

Deaths Deaths reported on FDA web sitereported on FDA web site

4,556 deaths4,556 deaths for medical devices in for medical devices in 20092009 ( (increased 60%increased 60% compared to compared to 2006). 2006).

1

Improving SafetyImproving Safety

Clinical trialsClinical trials

InspectionsInspections

Any flawsAny flaws can be caught can be caught soonersooner with with post-market studies, registries, post-market studies, registries, surveillancesurveillance

ConclusionsConclusions Can’t have evidence-based medicine Can’t have evidence-based medicine

with no evidencewith no evidence

IOM says that over 95%IOM says that over 95% of new medical of new medical devices have devices have no clinical trials and are no clinical trials and are not proven safe or effective not proven safe or effective

Clinical trials are Clinical trials are less stringentless stringent for for devices than for prescription drugsdevices than for prescription drugs

Consumers Should CareConsumers Should Care

Half billionHalf billion 510(k) devices 510(k) devices were recently were recently recalled as recalled as high risk high risk

Approx 15% Approx 15% of regulated devicesof regulated devices are are recalled as high or moderate riskrecalled as high or moderate risk

Diana Zuckerman, PhDDiana Zuckerman, PhD

President President National Research Center for Women & National Research Center for Women &

FamiliesFamilies

Cancer Prevention and Treatment FundCancer Prevention and Treatment Fund

www.center4research.org

www.stopcancerfund.org