Teratogens and Birth Defects
ScienceDaily (Dec. 29, 2004) — San Juan, Puerto Rico, December 12, 2004 – A new study conducted in rats by the National Institutes of Health (NIH) and McLean Hospital/Harvard Medical School suggests that the misdiagnosis of attention-deficit hyperactivity disorder (ADHD) combined with prescription drug use in children may lead to a higher risk of developing depressive symptoms in adulthood.
Sherri Finkbine, a TV presenter from
The 30-year-old mother decided to terminate her fifth pregnancy after discovering that tranquilizers she had taken in the first few weeks of her pregnancy contained the drug Thalidomide.
In recent months there has been increasing evidence suggesting Thalidomide causes severe foetal deformities including missing limbs, deafness and blindness.
Public condemnation
Mrs Finkbine, host of children's television programme "Romper Room", told her story to the local newspaper, believing it would alert other mothers in the same situation to the dangers of the drug.But she became the focus of an intense anti-abortion campaign and worldwide public condemnation.
The negative publicity led her local hospital in
Mrs Finkbine and her husband, Robert, a school teacher, took the case to the Arizona State Supreme Court but were unsuccessful. Despite vilification from anti-abortionists across the
After the operation it was confirmed that the foetus had no legs and only one arm.
Courtesy BBC
2008 is the 50th anniversary of the
It’s estimated that the drug caused the death of up to 100,000 babies across the world.Those who survived were left with severe deformities. In
New campaign
A campaign has been launched featuring Thalidomide survivors who are all middle-aged.When they were born, around 40 years ago, hardly anyone believed that they would live beyond childhood.One who’s beaten the odds is Dominic Galvin.He has brain damage and at 49 depends on his mum, Sadie, for everything.As well as spoon feeding him, his mother shaves him, washes him, brushes his teeth and dresses him every day.
Grunenthal
Like many pregnant women in the 1960s his mother was prescribed Thalidomide for morning sickness but the drug had a devastating effect.
Caring for Dominic is a 24 hour, seven-day-a-week job but, at £2,000 a week, professional carers aren’t an option. It’s money that Sadie just hasn’t got.The aim of the new campaign is to get compensation from Grunenthal, the German company that produced Thalidomide.The company’s never paid a penny to British survivors, although they have received a payout from a distributor of the drug.
Accelerated aging
Over the last few years those who have spent their lives dealing with the consequences of Thalidomide have had to contend with yet another curious challenge.As they’re going into middle-age they’re increasingly suffering from an uncharted and unexpected range of debilitating ailments, a unique medical phenomenon doctors had not anticipated.The accelerated aging process has huge financial consequences for the survivors of thalidomide.
In
Read Sukeshi's story in an exclusive web interview on BBC
The fight continues
In their 40s Thalidomiders are beginning to have to pay for the type of medical care and daily support you’d only normally expect in your 80s.
So the need for cash to ensure they are cared for decently is urgent.
The campaign may have a long way to go, but Thalidomiders have spent their lives fighting for their cause and they’re determined to win in the end.
In 1960, during her first month at the Food and Drug Administration, Dr. Frances Oldham Kelsey took a bold stance against inadequate testing and corporate pressure when she refused to approve release of thalidomide in the United States. The drug had been used as a sleeping pill and was later proven to have caused thousands of birth deformities in Germany and Great Britain.
Born Frances Oldham in 1914, on Vancouver Island, British Columbia, she earned both her bachelor of science and master of science degrees from McGill University, Montreal, in 1934 and 1935. In 1938 she earned her Ph.D. from the University of Chicago, and went on to teach there from 1938 to 1950. Dr. Frances Oldham married Dr. Fremont Ellis Kelsey, a fellow faculty member at University of Chicago, in 1943. Their two daughters were born while she earned her medical degree at the University of Chicago Medical School.
Dr. Kelsey then worked as an editorial associate at the American Medical Association before teaching pharmacology at University of South Dakota from 1954 to 1957. She was a general practitioner there from 1957 to 1960. In 1960 she moved to Washington, D.C., and began her long and distinguished career at the Food and Drug Administration, where she later became chief of the Division of New Drugs, director of the Division of Scientific Investigations, and deputy for Scientific and Medical Affairs, Office of Compliance.
Dr. Frances Kelsey took her stand against thalidomide during her first month at the Food and Drug Administration, on her first assignment. The task was supposed to be a straightforward review of a sleeping pill already widely used in Europe, but Kelsey was concerned by some data suggesting dangerous side effects in patients who took the drug repeatedly. While she continued to withhold approval, the manufacturers tried everything they could to get around her judgement.
In November 1961, reports began to emerge in Germany and the United Kingdom that mothers who had taken thalidomide during pregnancy were now having babies with severe birth defects. Dr. Helen Taussig learned of the tragedy from one of her students and traveled to Europe to investigate. By testifying before the Senate, Tauusig was able to help Kelsey ban thalidomide in the United States for good. At least 4000 children in Europe were affected by the drug, but thanks to Kelsey's rigorous professionalism a similar tragedy was averted here in America.
On August 7, 1962, President John F. Kennedy awarded Frances Kelsey the highest honor given to a civilian in the United States, the President's Award for Distinguished Federal Civilian Service. She was the second woman to ever receive the award. Kennedy acknowledged "Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States. Through high ability and steadfast confidence in her professional decision she has made an outstanding contribution to the protection of the health of the American people."
Kelsey helped shape and enforce amendments to FDA drug regulation laws to institutionalize protection of the patient in drug investigations. These regulations required that drugs be shown to be both safe and effective, that informed consent be obtained from patients when used in clinical trials, and that adverse reactions be reported to the FDA. In 1995, the town of Mill Bay, British Columbia, honored Dr. Kelsey by naming the Frances Kelsey Secondary School for her. In 2000, Kelsey was inducted into the National Women's Hall of Fame, and in 2001, at the age of 87, she became a Virtual Mentor for the American Medical Association.
On
A hearing of the House Energy and Commerce Committee's oversight subcommittee focused on advertising campaigns for three drugs, including the remarkable case of Robert Jarvik. Jarvik is featured in endlessly re-run ads for Pfizer's blockbuster cholesterol drug Lipitor. Known as the inventor of the Jarvik artificial heart, he is not a cardiologist, not a licensed medical doctor and not authorized to prescribe pharmaceuticals. He's shown in the ads engaged in vigorous rowing activity, but in fact he doesn't row. Pfizer pulled the ads in February after controversy started brewing.
Among industrialized countries, only the
Researchers Marc-André Gagnon and Joel Lexchin conclude in a recent issue of the journal PLOS Medicine that direct-to-consumer ads make up less than a tenth of industry marketing expenditures ($4 billion of $57.5 billion in 2004). And Gagnon and Lexchin's estimate of $57.5 billion on marketing excludes many industry expenditures that are really driven by marketing, including clinical trials conducted for marketing purposes.The bulk of the industry marketing effort, more than 70 percent by Gagnon and Lexchin's calculation, is directed at doctors. Why? Because it works.
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