Not exact matches
That
thalidomide was not approved for sale
in the United States was more
of a bureaucratic fluke than anything else.
For some time, no one suspected that
thalidomide was the cause
of the significant increase
in the incidence
of phocomelia.
The company challenges the claim that
thalidomide can cause limb defects that are confined to one side
of the body, as seen
in nine
of the plaintiffs.
In a new twist
of a historic tragedy, 13 Americans who say they are survivors
of thalidomide are suing four companies for producing and distributing the notorious drug.
The lawsuit, filed
in a Philadelphia court on 25 October, asserts that before
thalidomide was pulled from markets around the world, samples were doled out to more than 1,200 physicians
in the United States by three companies whose legal liabilities are now the property
of Sanofi - Aventis US, based
in Bridgewater, New Jersey.
«There are no representative, controlled studies documenting the true spectrum
of thalidomide injuries,» they write
in the lawsuit.
Holmes also notes that the relative paucity
of thalidomide births
in the United States means that few researchers there can speak with authority on the drug's effects.
The pharmacologist felt the animal studies submitted were not a good indication
of possible toxicity
in humans, since animals absorb
thalidomide poorly.
President John F. Kennedy honors FDA medical officer Frances Kelsey
in 1962 for her work blocking U.S. approval
of thalidomide.
Meanwhile, reports
of startling birth defects
in babies born to mothers who had taken
thalidomide were surfacing
in Germany, Australia and other countries where the drug was legal — including Kelsey's native Canada.
In July 1962, a detailed story about America's close call with
thalidomide appeared on the front page
of The Washington Post, under the headline «Heroine
of FDA Keeps Bad Drug Off Market,» with a photo
of Kelsey.
FDA medical officer Frances Oldham Kelsey averted the tragedy
of thalidomide birth defects
in the United States
The company
in - licensed
thalidomide in 1992 and received FDA approval to market the drug (as Thalomid) for treating severe cutaneous manifestations
of leprosy
in 1998 and for treating multiple myeloma
in combination with dexamethasone
in 2006.
Starting
in 2008, Marzia Lazzerini
of the Institute for Maternal and Child Health
in Trieste, Italy, and her colleagues randomly assigned 54 children with Crohn's to get daily
thalidomide or a placebo.
A new study published
in the March 12 issue
of Science has identified one primary target
of thalidomide's teratogenicity (potential to cause fetal malformations)-- a protein called cereblon.
In both zebrafish and chick embryos, adding a version
of cereblon that doesn't bind to
thalidomide seemed to blunt the drug's effects.
The prime example is
thalidomide, which was outlawed
in the 1960s because it caused birth defects but has now found a niche
in the treatment
of cancer and leprosy.
When they gave
thalidomide to seven HHT patients, six had significantly fewer nosebleeds within a month
of their first dose, Mummery and colleagues report online today
in Nature Medicine.
A pilot study
of thalidomide, published
in 2001, found the drug improved blood counts
in some patients and enabled others to become transfusion - independent.
Dr. Kelsey, 69, was honored for her successful crusade to prevent the marketing
of the sleeping pill
thalidomide in the United States.
THE NEWS THESE DAYS is rarely good, but two stories
in recent editions
of the newspaper were truly shocking: a posse
of 15 policemen had stormed the Contemporary Arts Center
in Cincinnati and, temporarily, closed down the traveling exhibition «Robert Mapplethorpe: The Perfect Moment»; and further, medical researchers had suggested that the drug
thalidomide be reintroduced on the market as an effective therapeutic treatment
He was well known for playing a crucial role, as an expert witness,
in winning compensation for the victims
of thalidomide.
Meyer had said among other things that for 30 years the Contergan (
thalidomide) manufacturer Grunenthal GmbH had had access to the medical files
of the Contergan victims
in the Contergan Foundation.
Representing Grünenthal on the major product liability case involving a claim for damages
in over $ 204m filed by the Spanish Association AVITE (Asociación de Víctimas de la Talidomida en España) representing 184 victims
of thalidomide, for alleged damages caused
in the 1960's for the administration
of thalidomide.