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 ongoing repurposing of the infamous
drug thalidomide may include treatment of Crohn's disease, an incurable bowel condition.
Steingraber cites the disasters of
thalidomide in the U.S. and methyl mercury in Japan (Minamata), and presses for a zero tolerance of all environmental contaminants.
In the late 1950s and early 1960s, doctors prescribed
thalidomide as an antinausea drug for pregnant women with a regularity that proved tragic.
Handa's team found that beads tagged
with thalidomide bound to a little - known protein called cereblon, which is expressed widely in both embryonic and adult tissues.
FDA medical officer Frances Oldham Kelsey averted the tragedy of
thalidomide birth defects in the United States
William McBride, the Australian obstetrician credited 30 years ago with alerting the world to the birth defects caused
by thalidomide, was struck off the medical register by the New South Wales Medical Tribunal last week.
Ito and colleagues hope the identification of cereblon as a target
for thalidomide teratogenicity will lead to rapid screening for similar, safer alternatives.
«Today, a number of
thalidomide babies continue to be born each year reflecting regulatory insufficiency and widespread use under inadequate supervision,» the organization's Web site states.
«There are no representative, controlled studies documenting the true spectrum of
thalidomide injuries,» they write in the lawsuit.
Toxicologist Craig Harris of the University of Michigan, Ann Arbor, who has
studied thalidomide's effects on gene expression, says that the new data are consistent with some theories of the drug's action, however.
(In the United States, people
given thalidomide for myeloma are instructed to use multiple forms of birth control and take frequent pregnancy tests.)
It's important to know if the agent in question is perfectly safe or has the potential to be lethal or cause limb defects
like thalidomide did,» Bushdid said.
Although the FDA has approved limited
thalidomide use, the World Health Organization (WHO) does not recommend it, citing worries over ineffective surveillance and drug misuse.
The
infamous thalidomide drug that cause birth defects in past decades show that it took many good doctor to through the whole process.
More than 10,000 children in 46 countries were born with missing limbs and other deformities
before thalidomide's manufacturers pulled it from the market.
Lewis Holmes, an expert in birth defects at Massachusetts General Hospital in Boston, says that the plaintiffs will have an uphill struggle to support their argument from the scientific literature because of the lack of systematic studies that follow up the offspring of women who
took thalidomide during pregnancy.
If you look at the original work on the epidemiology of thalidomide [a morning - sickness drug that turned out to cause birth defects], there were specific time points where, if the woman was exposed, the baby had a high probability of having bona fide autism.
Using zebra fish and chick embryos, Takumi Ito and colleagues from the Tokyo Institute of Technology showed that
thalidomide binds to cereblon, causing pectoral fin malformations in zebra fish and the complete absence of forelimbs in chicks.
The results offer new insight into
how thalidomide affects blood vessels, says Mummery.
Scientists are therefore eager to understand exactly how
thalidomide does its damage so that they can preserve the benefits of the drug without its hazards.
Although thalidomide has been the subject of hundreds of studies, we still do not know exactly how it causes its effects.
While thalidomide apparently is relatively safe for adults, it can have disastrous effects on developing embryos.
Don't wait for the too little too late DES and
thalidomide style recalls, decades after the fact.
Until now, most US cases were thought to originate
from thalidomide obtained abroad.
She notes that Smith Kline & French never manufactured or
sold thalidomide and adds: «The Plaintiffs» complaint is replete with scientific inaccuracies and misstatements.»
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.
Even though Kelsey and her team
kept thalidomide off the American shelves, many doctors had dispensed «investigative samples» of the drug.
The pharmacologist felt the animal studies submitted were not a good indication of possible toxicity in humans, since animals
absorb thalidomide poorly.
Much like BMS, Celgene also made a big gamble about a decade ago when it developed a class of immune - modulating drugs that included the infamous
teratogen thalidomide.
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.
The researchers concluded that
thalidomide exerts these effects by inhibiting cereblon function, because genetically induced overproduction of cereblon prevented the malformations.
Today,
thalidomide trials are ongoing in more than 30 diseases, according to Adis R&D Insight (an online database of drug developments), including arthritis, breast cancer and amyotrophic lateral sclerosis.
In both zebrafish and chick embryos, adding a version of cereblon that doesn't bind to
thalidomide seemed to blunt the drug's effects.
While too late to help those whose lives were blighted by the drug during pregnancy, this finding could help
rehabilitate thalidomide, which is effective against several serious conditions, including multiple myeloma, a form of cancer.
Dr. Kelsey, 69, was honored for her successful crusade to prevent the marketing of the sleeping
pill thalidomide in the United States.
The pain of Metroid Prime 2 is something of a literal thing as well, as my hands twisted into
curled thalidomide claws after hours of locked - on strafing.
I guess the don't give leave to poor disabled
-LCB- thalidomide -RCB- people sueing rich lawyers.
They also worried that experimental treatments might harm pregnant women or their babies, especially after the 1960s, when the morning sickness
drug thalidomide was found to cause birth defects.