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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Sunday, September 2, 2012

Thalidomide & Failed Implants-Egregious Harm


Published: September 1, 2012  New York Times  (FiDA highlight added.)

LONDON — Decades of campaigning by victims of thalidomide, a morning sickness drug, have taken a new turn, with the first apology in 50 years to the victims and their families by the drug’s German manufacturer — and an incensed rejection of the apology as too little and too late from many of those it was intended to placate.

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The apology was issued Friday by Harald Stock, chief executive of the Grünenthal Group, a family-owned pharmaceutical company that marketed the drug in the 1950s and early 1960s. It was withdrawn in 1961 after it was linked to birth defects, including shortened arms and legs, and in some cases no limbs at all, that campaigners say affected 10,000 babies around the world, mostly in Australia, Canada, Europe and Japan.
The apology came in a speech Mr. Stock delivered in the Rhineland town of Stolberg, the company’s base, at the unveiling of a thalidomide memorial, a bronze statue of a limbless child.
Addressing the victims and their families, he said the company wished to “apologize for the fact that we have not found the way to you from person to person for almost 50 years.
“Instead, we have been silent, and we are very sorry for that.”
According to an English translation of his remarks that appeared on Grünenthal’s Web site, he added, “We ask that you regard our long silence as a sign of the shock that your fate caused in us.” As for the company’s delay in moving beyond its previous expressions of regret for marketing the drug to a direct apology to the victims, he said that in recent discussions with victims and their families, “we learned how much it is publicly desired that we express our deep regrets to those affected by thalidomide.”
Although thalidomide was never approved for use by pregnant women in the United States, some victims are American.
One is Berrisford Boothe, 51, an associate professor of art at Lehigh University in Bethlehem, Pa., who described himself in a telephone interview as one of 26 known American thalidomide victims. He said he had been born with severe disabilities in both hands and one arm, and described his life as a “long and isolated journey.”
Now, he said, Grünenthal, shaken from a half century of denial by a class-action lawsuit in Australia, had made “some kind of statement that they are emotionally connected to our suffering. They’ve had 50 years to make billions of dollars while we struggled and our parents committed suicide. And now, they’re apologizing for not saying anything. How dare they do that and think it’s going to be enough?”
Mr. Stock said the company had carried out all the tests on thalidomide before it was marketed that were possible given the scientific knowledge available in the 1950s.
But the storm of protest the apology provoked from thalidomide victims and groups that represent them suggested that it had done little to assuage the anger and hurt accumulated over decades of campaigning for a full acknowledgment of thalidomide’s harm, and for more generous compensation.
“It is over 50 years on since the thalidomide tragedy — why now?” said Freddie Astbury, chief consultant at Thalidomide U.K. Agency, which represents people in Britain, where nearly 500 victims survive. He said British victims had received some compensation from the government and from distributors of thalidomide, but not enough.
Mr. Astbury, 53, who was born with no arms and no legs, said he believed that one reason for Mr. Stock’s speech was greater global awareness of issues affecting the disabled, manifested by the success of the Paralympic Games in London.
He pointed, too, to the Australian lawsuit, which legal experts say can result in new compensation awards for thalidomide victims running into tens of millions of dollars.
“We are glad the apology has been made,” he said. “But when you are disabled, it costs a lot of money. We are in our 50s, we need care. We need adaptations in our houses and cars, for starters. So if they’re serious, let’s get around the table and talk financial help.”
He added: “We didn’t ask to be born this way.”
Sandy Macaskill contributed reporting.

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