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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Thursday, May 15, 2014

Mounting Patient Harm and FDA history of medical device disasters!



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

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