Mounting Patient Harm and FDA history of medical device disasters!

ArtifactsTell the Story of Our Culture and FDA’s History

Posted on May 13, 2014 by FDA Voice  FiDA highlight

By: John Swann, Ph.D.

Looming sentry-like over the collection of artifacts that document FDA’s  history, the products  we regulate, and our interactions with the public is a rather large and curious figure. It is a green velvet head with bulbous, languid eyes and two upper teeth in an otherwise large and empty mouth. It doesn’t have ears or hair, but is marked by a few bright green pustules.  This is part of a life-size costume, an element of a public education campaign called Fight Bac! in which FDA was a major participant. It began in the 1990s to alert the public, young and adult alike, to the dangers of food-borne diseases and how to avoid them.

Countless objects in our collection tell the decades-long tale of FDA’s educational activities. For example, the agency still has a cabinet and some of its contents from the “Chamber of Horrors” exhibit that traveled around the country in the early 1930s to alert citizens, legislators, the press and others of the need for a stronger consumer protection law, drawn from egregious examples of how the law then in place fell short.  FDA officials also communicated through a variety of other displays for Congressional testimony and other purposes.

Much of the collection captures the problems that gave rise to the laws and regulations we have today, a regulatory arc often originating with a problem product—sometimes of disastrous proportions. Thus one can find specimens of:

▪                Elixir Sulfanilamide, a poisonous preparation of a wonder drug in 1937;

▪                thalidomide,  the globally marketed sedative that caused thousands of grave birth defects in the 1950s and 1960s;

▪                Bon Vivant vichyssoise, a botulism threat in the early 1970s;

▪                the ill-designed Dalkon Shield intrauterine device that caused thousands of pelvic infections; and

▪                ephedra-containing dietary supplements from the 1990s that killed several users.

These are among the objects that eerily illustrate why we have the laws and regulations we do.

Decision-making in the agency depends to a considerable extent on investigations and analyses, some of the tools of which are documented here. These artifacts of the growth of regulatory science include:

▪                balances and early calculating devices used in the laboratories of the Bureau of Chemistry from the 1900s to 1920s to analyze questionable foods and drugs;

▪                triers, tools used for routine sampling of various foods to ensure compliance with the law, from the mid-20th century; and

▪                advanced analytical devices from the 2000s to detect sophisticated counterfeiting of medicinal products.

Treatments of dubious value for both serious and non-serious diseases make up a significant part of the collection as well. There are hundreds of fraudulent medications, primarily up to about World War II, as well as hundreds of medical devices from the 1950s and 1960s that offered hope with no scientific underpinning.

In addition, how the public came to engage FDA and its work, especially from the 1970s forward, can be seen in a number of objects, including protest buttons and placards from the past two decades.

Artifacts like these tell the story of how our many laws and regulations came to be, how FDA has carried them out, and how the public and FDA have engaged each other in the interest of the public health.

John Swann, Ph.D., is an Historian at FDA

- See more at: http://blogs.fda.gov/fdavoice/index.php/2014/05/artifacts-tell-the-story-of-our-culture-and-fdas-history/#sthash.XEiRd40Z.dpuf

End Secrecy, Save Lives: Consumers Union patient stories

Steven Baker profiled by Consumers Union Safe Patient Project.
Information on growing patient harm is suppressed by powerful interests that benefit from underfunded research and regulation.  Taxpayers and consumers deserve to know which medical devices are safe and effective.  (Especially now when joint replacements are the #1 expenditure of Medicare!)  Patients deserve to know more about an implant device than they do about a toaster oven they are considering for purchase.  Informed consent must include a discussion about the FDA 510(k) clearance debate and medical device Supreme Court pre-emption (Riegel v Medtronic) and tort reform that weakens patient protections when a device fails.  The epic failures of various ICD's, surgical mesh and metal-on-metal hips were preventable.  The device industry is not entitled to profit without accountability.
Please support Consumers Union Safe Patient Project!  These patients are bravely telling their stories to benefit us all!  

Cardiologists Arrested: Human Experimentation

http://www.forbes.com/sites/larryhusten/2012/11/11/nine-italian-cardiologists-arrested-in-broad-investigation-of-research-fraud-and-misconduct/

Larry Husten, Contributor

A medical journalist covering cardiology news.

PHARMA & HEALTHCARE | 11/11/2012 @ 7:59PM  (FiDA highlight)

NineItalian CardiologistsArrested In BroadInvestigation Of Research Fraud And Misconduct

Nine Italian cardiologists have been arrested as part of a broad investigation into serious medical misconduct at Modena Hospital, according to multiple reports in the Italian media. The investigation encompasses at least 67 other individuals and a dozen medical equipment companies, including 6 foreign companies. The charges include conspiracy, fraud, embezzlement, bribery, forgery and performing unauthorized clinicaltrials. Several news reports mentioned that stents and angioplasty balloons were involved.
According to one Italian website, the investigation started in 2011 in response to allegations by a group, Amici del Cuore (Friends of the Heart), that patients at the Modena Hospital (Policlinico di Modena) received treatments and procedures as part of unauthorized experiments. In some cases the procedures may have resulted in fatal outcomes. The accused physicians ”performed experimental tests without making it known to patients for the sole purpose of writing about these trials in specialized magazines collecting money through bogus non-profit organization,” the website reported. [All translations in this story taken from Google Translate.]

“We wanted to ask questions about certain procedures that went far beyond the standard ones, and that seemed unusual to us,” the president of Friends of the Heart, Professor Giovanni Spinella, told Il Salvagente. “We were aware that invasive procedures were performed, often on peripheral organs, and sometimes had little to do [with] the heart. And unfortunately had caused discomfort and damage to several patients.”

Another Italian site quoted a police official who called it “a major operation” and said the accused “committed human clinical trials without authorization and installed medical devices and equipment defective in patients unaware of being subjected to an experimental treatment.” The accused physicians then “created false medical records to cover medical errors.” The Italian media said the investigation included recordings of telephone conversations between the suspects. The Italian police named the operation camici sporchi (“dirty gowns”).

The most prominent person arrested was Maria Grazia Modena, the chief of cardiology at Modena Hospital and a former president of the Italian Society of Cardiology. (Grazia Modena was the subject of a profile in Circulation European Perspectives (PDF) in 2007.) Modena, 60 years old, was trained partly at New York University and the Mayo Clinic. The second main focus of the investigation appears to be the head of the catheterization laboratory at the hospital, Giuseppe Sangiorgi. According to news reports, he is the only arrested physician who is still in jail.

Here are the names of the nine physicians:

•               Maria Grazia Modena, chief of cardiology

•               Giuseppe Sangiorgi, head of the catheterization laboratory

•               Luigi Vincenzo Politi

•               April Alexander

•               Simona Lambertini

•               Giuseppe Biondi Zoccai

•               Fabrizio Clement

•               Alessandro Mauriello

Andrea Amato, 36

National Physicians Alliance: 'Un-Branded' Doctors

http://npalliance.org/press/press-releases/modest-means-modest/

Health Care For All, MASSPIRG, AARP Massachusetts, National PhysiciansAlliance, American Medical Student Association And Community Catalyst Urge DPHTo Protect Patients, Amend Drug Marketing Regulations And Conform To Law

Press Release: October 19, 2012

Leading consumer, health care, senior and community advocates voiced strong opposition to emergency regulations weakening the state’s prescription and medical device marketing law at today’s Department of Public Health hearing.

The regulations implement a law passed last summer to relax state restrictions on meals provided by pharmaceutical and medical device companies to doctors and other prescribers. Under the previous law, meals may not be provided unless in a clinical setting. The amended statute permits “modest meals and refreshments” to be offered at educational programs outside of a health care setting, such as a restaurant.

Representatives of numerous advocacy groups testified in favor of improving the emergency regulations. The rules ignored the legislative direction to limit permitted meals to those considered modest, and instead defined “modest” as “similar to what a health care practitioner might purchase when dining at his or her own expense.”

“We urge the Department to comply with the directive given in the amended statute and define ‘modest meals and refreshments’ in clear, concrete and enforceable terms. Alcohol should be expressly prohibited, as alcohol is contraindicated for educating doctors about drugs and treatments that affect their patients’ health,” said Amy Whitcomb Slemmer, Executive Director of Health Care For All. “If the proposed regulations are not significantly strengthened, we will inevitably go back to the days of pharmaceutical and device sales representatives inappropriately wining and dining our doctors.”

“The bottom line is that drug companies wine and dine doctors and other prescribers to sell their newest, most profitable brand name drugs, not to provide unbiased academic information on medical care,” testified Deirdre Cummings, MASSPIRG’s legislative director. “While the whole practice ought to be eliminated, at the very least, the regulations should accurately reflect the law. Free meals provided by the drug industry to physicians must truly be modest, and in an environment conducive to learning.”

“We urge DPH to establish a concrete monetary limit to define the term ‘modest,’ and we felt strongly that these meals should exclude alcohol. Instead, the proposed regulations have no monetary restriction, and permit the provision of alcohol,” Cummings added

“The medical profession prides itself on putting patients first. By not setting a clear dollar limit in its definition of ‘modest meals and refreshments,’ the Department of Public Health compromises our profession’s integrity,” said David Tian, a fourth-year Harvard Medical School student and national chair of the American Medical Student Association (AMSA) PharmFree campaign. “Patients deserve to know that their doctors’ prescribing choices are determined by the best scientific evidence, not which company promised the fanciest meal to lure prescribers into a one-sided presentation.”

As a result of the new regulations, drug companies are currently free to ply doctors with lavish multi-course meals and drinks, paid for by pharmaceutical industry marketing budgets, and ultimately tacked on to the price of prescriptions.

“AARP believes relationships between drug companies and doctors should be transparent and free from conflicts of interest,” said Jessica Costantino, advocacy director of AARP Massachusetts, which serves more than 800,000 members age 50 and older in the commonwealth. “The decision by the Public Health Council to approve regulations that further weaken the state’s Prescription Drug Gift Ban Law, ultimately puts the best interest of patients at risk.”

“Massachusetts is in danger of plummeting below its former place as a national leader in protecting patients from pharma marketing practices that interfere with trust between patients and their health care providers. The regulations also ignore the intent of the legislature by scrapping required disclosures to the state of industry payments to nurse practitioners and physicians assistants, which will not be required under the new federal transparency law that covers physicians.” says Marcia Hams, Director of Prescription Access and Quality at Community Catalyst. “These prescribers are increasingly the target of industry marketing now that they are critical to meeting primary care needs in the state.”

“I just want the best for my patients, and protecting the patient-physician relationship should be the focus of industry-oriented legislation, which the current gift ban regulations fail to do”, said Dr. Constance Liu, OB/Gyn department at Boston Medical Center and Boston leader of the National Physicians Alliance.

Following the hearing, the Department of Public Health plans to review testimony and issue permanent rules in November.

http://npalliance.org/wp-content/uploads/NPA_2012_Current_Program1.pdf

agenda November 11, 2012

NPA Annual Conference 

National Physicians Alliance

From Wikipedia, the free encyclopedia

National Physicians Alliance
Motto	Service, Integrity and Advocacy
Formation	2005
Type	501c(3)
Headquarters	Washington DC
Location	United States
Membership	20,000 physicians
President	Valerie Arkoosh, MD, MPH
Key people	Jean Silver-Isenstadt, MD, PhD
Website	npalliance.org

The National Physicians Alliance (NPA) is a national, multi-specialty medical organization founded in 2005 by former leaders of the American Medical Student Association. The organization's mission statement reads: "The National Physicians Alliance creates research and education programs that promote active engagement of physicians with their communities to achieve high quality, affordable health care for all. The NPA offers a professional home to physicians across medical specialties who share a commitment to professional integrity and health justice."

The NPA was founded as an alternative to traditional trade associations that operate in a guild tradition, primarily serving the economic interests of physicians rather than advocating first and foremost on behalf of patients and public health. The NPA does not accept funding from pharmaceutical or medical device companies.

A 501c(3) organization based in Washington DC, the NPA has a membership of approximately 20,000 physicians. Members must have graduated with an MD or DO degree from a professional school accredited by the LCME or the AOA-COCA; or hold a license to practice medicine within the United States.

UDI's will reduce patient harm

http://www.dotmed.com/news/story/19856?p_begin=0

GPOs want newmedical device labeling faster, medical device companies ask for more time

November 09, 2012

by Brendon Nafziger , DOTmed News Associate Editor (FiDA highlight)

Group purchasing organizations want the Food and Drug Administration to hurry up its timeline for implementing new medical device labels and a tracking system that could make recalling products easier and more efficient, while medical device companies fret that the process needs more time.

The groups submitted comments to the FDA this week as the comment period for the new unique device identifier (UDI) proposed regulation ended Wednesday.

Janet Trunzo, a senior executive of regulatory affairs for AdvaMed, a medical device manufacturer trade group, called the project "one of the most extensive and complex regulations to be issued in recent memory."

Based on a recent survey commissioned by the group, AdvaMed estimates UDI implementation could cost manufacturers millions in setting up new production equipment and possibly billions if they were forced to recall and destroy lots of old devices.

"Because of the cost and impact of this rule for companies we believe it is imperative that FDA get it right the first time," she told reporters on a press call Thursday.

What is the UDI?

The UDI itself is a two-part system, wtih an alphanumeric code that identifies the device model and and production identifier that gives the serial, lot or batch number, and an expiration date. The UDI would appear on device labels and packaging in plaintext, intelligible to humans, and a machine readable format, such as a barcode. The other major element is the Global UDI Database, an under-construction public online database that could help the government or providers track products during a recall.

The UDI rule, long championed by patient advocates, has been in the works for several years, but was given a push this summer when Congress passed an FDA user fee renewal bill that included language forcing the FDA to come up with proposed rules by the end of the year. The FDA released those rules in July.

Timeline

For stakeholders involved in this immense, multi-year project, one of the key issues is when they'll have to comply with the final rules, which are expected next year.

Under its proposed rules, published this summer, FDA put in place a staggered timeline, with higher-risk (Class III) devices expected to have UDI labeling on packaging or devices within one year of the publication of the final rule, intermediate-risk devices (Class II) within three years, and lower-risk (Class I) and unclassified devices in five years.

Some products, like implantable devices and software, require the UDI printed directly on the device itself, in a process called direct marking. This will be required from three to seven years after the final rule is published, with riskier devices getting direct marking first.

Too fast

Medical device manufacturers, perhaps unsurprisingly, disagree, and they stress the expense and cost of switching over to the new system: they will have to buy and install new labeling machines in factories, implement and validate production software and train staff.

In its comments submitted to the FDA, AdvaMed urged the agency to delay Class III requirements by one year, for a two-year post-final rule effective date. "There is no direct device safety and effectiveness issue that is compromised by extending the effective date for Class III devices by one year, and doing so will assist regulated persons and those in the health care community to integrate the UDI into their daily practices effectively," the group wrote.

The lobby also wants to clarify what they say could be one of the biggest troublemakers with implementing the system: what to do about devices that were created before the regulations take effect. That's why AdvaMed is asking that the rules be prospective, and only apply to devices produced after the effective date.

"The cost of applying UDI requirements to existing inventory once an effective date is reached is huge," AdvaMed said in its comments. "For example, sterilized devices cannot, in all cases, be safely and economically re-labeled, re-packaged and re-sterilized, and therefore, must be destroyed. Other devices that arguably could be reprocessed would present such large expense that doing so would be impractical. More importantly, such massive reprocessing would interfere with other device production, thus threatening potential shortages and an endangerment to public health."

Financial impact

AdvaMed has tried to come up with some figures to show how costly implementing UDIs would be to the industry, specifically focusing on the impact of direct marking.

According to an Accenture survey of 18 companies commissioned by the lobby and released Thursday, three-quarters expect significant costs for switching production lines to direct marking. The total associated costs per packaging line averaged around $125,000, according to the survey. All told, about 44 percent of respondents said they'd have to spend upwards of $1 million to purchase new manufacturing equipment, and the complete one-time cost of putting the system in place for all respondents was nearly $80 million.

n addition, respondents estimated they'd have to spend $2.8 billion in total to recall and reconfigure non-compliant equipment.

Retail exceptions

In addition to the timeline, GPOs and manufacturers are also somewhat split on the issue of medical products sold at drug stores. The FDA's proposed rules contain an exception for requiring UDI labels to products sold at retail outlets.

AdvaMed thinks the FDA should keep the rule as-is, and that all non-prescription retail products should be able to use the ubiquitous Universal Product Code "as an adequate unique device identifier." The group says that the UPC does what the UDI is meant to do and enables products to be accurately tracked.

But GPOs seem wary, at least in part. "Some of these retail products include automatic external defibrillators, insulin syringes and glucometers," Premier said. While Premier said the UPC could count as a UDI, they should still be subject to the UDI requirements, such as reporting to the product database.

Novation also backs limiting or doing away with the retail exception. "Novation does not believe a blanket exception of Class I devices sold in a retail setting is appropriate, nor in the best interest of patients," the GPO said in its release.

More exemptions

The manufacturers also want the FDA to create a specific list of devices that would ordinarily require direct marking, such as implantable devices, but are exempted from the requirement. Under the proposed rule, companies can "self-exempt" products that can't be directly marked, but the manufacturers worry that without a clear, explicit list of exempted devices they could be challenged by FDA field inspectors and receive citations or warning letters.

"We're requesting and have submitted a list of devices that are intrinsically unmarkable, and we go into details of what that would entail," Jeff Secunda, AdvaMed's VP of technology and regulatory affairs, said on a press call. Examples would include small dissolvable objects like absorbable sutures or amorphous ones like bone putty.

They also want to expand an exemption for lower-risk products sold in dispensing packs. Under the proposed rule, Class I items sold in boxes need a UDI for the box, but not each individual product. AdvaMed wants to expand this to all devices.

More broadly, the group questions the wisdom of direct marking implantable products in general, arguing that it makes more sense to have the packaging labeled, which would then be scanned before the device is implanted, with the scanned information getting logged into a patient's electronic health record.

"During, or just prior to, surgical implantation of the device the UDI is entered into the patient's EHR providing a permanent link between the patient and the implanted device," the group said in its comments. "This information will be available to all those who are authorized to access the patient's EHR and will not require a surgical procedure to extract the device and scan the UDI. Postmarket surveillance is conducted non-invasively on EHRs databases."

Under the FDA user fee renewal bill, final UDI rules would have to be issued within six months of ending the comment period -- that is, in May. 

Why Not to Invest in Implanted Medical Devices?

Outlook gloomy for device investments

J.K. Wall October 29, 2012  Indianapolis Business Journal

The mood was gloomy Oct. 23 as venture capitalists gathered at the Indiana Life Sciences Summit to discuss the environment for medical technology companies wanting to raise private institutional money.

And for good reason. The amount of venture capital invested in medical-device and -equipment companies nationally has declined each quarter this year, according to data released Oct. 19 by the National Venture Capital Association and PricewaterhouseCoopers.

Dollars invested in medical-device companies fell 37 percent in the third quarter, to $434 million across the country. That was the lowest dollar volume in a quarter since 2004. The number of deals dropped 27 percent, to 65, according to the National Venture Capital Association and PricewaterhouseCoopers.

Data for Indiana medical-device companies has yet to be released. Through the first half of the year, such Indiana firms had received pledges of more than $32 million in three deals, according to a tally kept by Cleveland-based BioEnterprises.

But those results were skewed by Indianapolis-based Strand Diagnostics LLC, which secured a five-year, $30 million commitment from a California financier for its blood-sample tracking system called Know Error.

The only other medical-device companies to raise money were Indianapolis-based IV Diagnostics, which secured $1.31 million in angel capital, and Fort Wayne-based Quantum OPS, which raised $1.05 million from a Pittsburgh life sciences fund.

The drop-off in appetite for medical-device companies flows from several factors. First, the U.S. Food and Drug Administration’s process for approving new devices has become much more uncertain. Also, the FDA is requiring more clinical trials before approving a medical device, extending the time-to-market for many firms.

Also, the potential for reimbursement payments for new devices is murkier than ever. And on top of that, a new 2.3-percent excise tax on medical devices kicked in this year to help pay for the expansion of health insurance coverage under President Obama’s health reform law.

That combination of headwinds has led many companies to launch products first in Europe and then later—if ever—bring them to the United States.

And the uncertainty is chasing off some investors who previously liked medical-device firms because they could get products to market faster than drug companies and yet still enjoyed markets with significant barriers to entry.

“Does it make sense anymore to have a med-tech-only fund?” asked Jonathan Silverstein, a partner at OrbiMed Advisors LLC in New York, who moderated the Oct. 23 panel discussion. The summit, organized by Indianapolis-based life sciences group BioCrossroads, was at the downtown Westin hotel.

No, was the clear answer he got from two of the panelists: Ron Hunt, a managing director of New York-based New Leaf Venture Partners, and Adele Oliva, a partner at Philadelphia-based venture fund Quaker Partners. The panelists also noted that many venture capital firms having been cutting back their med tech staff members.

"There are still med tech opportunities, but venture capitalists want to come in later," Oliva said.

That desire has stretched the so-called “valley of death” between an initial phase of startup capital and the point at which venture capitalists come in to about five or six years.

"It's because of the regulatory and reimbursement concerns," Hunt said, adding, "I don't know where the money is going to come from."

However, Bernard Yancovich, a managing partner at Credit Suisse who oversees the bank’s investments in Indiana-focused life sciences venture funds, said there’s still a place for medical-device investments as part of a broad-based portfolio approach.

Comment:  Joleen Chambers October 31, 2012

The medical device industry was not able to balance its’ aggressive drive to profit with the reality that "innovation" lead to significant patient harm.  When the product is no longer trusted, the product is harder to sell.  Consumers are not willing to pay higher insurance premiums and Medicare contributions to cover the cost of private companies' desire to exploit patients.  Industry leaders fought government oversight and did not provide internal checks on 'outliers'