Thalidomide goes on market: Oct. 1, 1957
A “wonder drug” named thalidomide goes on the market in Germany. It’s a sedative—without barbituates—and is considered so safe that it’s soon being sold over-the-counter in many countries, primarily in Europe and Australia. In fact, its inventors had bragged that “they could not find a dose high enough to kill a rat.” By 1960, thalidomide was almost as popular as aspirin, in terms of sales.
Many doctors were so convinced of thalidomide’s safety that they began prescribing it “off-label” as a treatment for morning sickness in pregnant women. But then, those doctors, to their horror, started seeing their patients having babies with awful birth defects, particularly a condition called phocomelia, in which the infants’ arms never developed, and instead hands grew from their upper arms like flippers.
After a German newspaper reported an apparent link between thalidomide use and 161 babies born with birth defects, the German government ordered the drug off the market. Other countries followed suit and by 1962, thalidomide was banned in most countries.
But not before more than 10,000 “thalidomide babies” with defects were born around the world. Research found that the drug’s molecules crossed the placental wall during pregnancy, especially during the first trimester, and that could cause profound problems in the growth of the fetus.
In the U.S., however, the damage from thalidomide was much more limited, thanks largely to efforts of one woman on her first assignment in the Food and Drug Administration (FDA). Her name was Frances Kelsey and she was part of a new wave of scientists who believed that drugs should not receive FDA approval unless the manufacturer could provide clear evidence that they were safe and effective. At that point, Congress hadn’t given the FDA that authority and Kelsey came under tremendous pressure from the drug company to give thalidomide a green light. But she resisted, concerned that there wasn’t enough data proving that the drug wouldn’t cross the placental wall.
She was shown to be right, and in the summer of 1962 President John F. Kennedy awarded Kelsey the highest honor given to a U.S. civilian—the President’s Award for Distinguished Federal Civilian Service. She was only the second woman to receive it.
That same year, primarily in response to the thalidomide crisis, Congress gave the FDA much more power in regulating the release of drugs in the U.S. Among the key changes was to give the FDA oversight of clinical trials. Previously, “clinical trials” involved not much more than pharmaceutical companies passing out drugs to doctors who had their patients “test” them. Manufacturers could put their medications on the market only 60 days after notifying the FDA. But after what happened with thalidomide, the process, designed by Kelsey herself, became much more comprehensive and demanding, Today, it can take longer than 10 years for a drug to be approved.
While it no longer is permitted to be used as a sedative, thalidomide has been found to be an effective treatment for both leprosy and multiple myeloma, a deadly blood cancer. In 2010, the FDA created the Kelsey Award. It’s given to a different FDA employee every year.
Frances Kelsey turned 100 in July.
More slices of history
Wine bacteria may have probiotic benefits
Bacteria in wine could have some of the same probiotic benefits often attributed to yogurt, according to a team of Spanish researchers. They found that the bacteria were able to survive in the human gastrointestinal system and are able to stick to the walls of a human intestime,
The probiotic properties of the lactic-acid bacteria isolated from wine are similar to those of probiotics that come from foods like dairy products such as fermented milk or yogurt and dry sausages.
The down side is that these benefits may not be gained by drinking a few glasses of wine a day because some probiotic properties are lost during the process of preserving wine. The potential, say the researchers, could be in isolating the bacteria in wine and using it for probiotic purposes.
The study will be published in the December issue of the journal Food Microbiology.
Can curry spice help heal brain?
A spice used commonly in curries may help boost the brain’s ability to repair itself. That’s the conclusion of a German study published in the journal, Stem Cell Research and Therapy.
Researchers focused on the compound aromatic-turmerone, found in the spice tumeric, and injected it into rats. After analyzing the scans of the rats’ brains, the scientists found that parts involved in nerve cell growth were particularly active. The team also studied the effects of the compound with rodent neural stem cells which have the ability to transform into any type of brain cell. They found that there was a greater growth of the cells when the extract of the compound was given to the animals.
Such positive effects, however, have not yet been seen in humans and often chemicals and medications effective in rats and mice don’t have the same impact in humans. That said, the researchers believe the findings could lead to more research to determine if the compound can be a part of efforts to fight Alzheimer’s disease and other cognitive disorders.
Talk therapy may help social anxiety more than drugs
People with social anxiety disorder–also known as social phobia–may benefit more from talk therapy than from drugs such as anxiety medications and antidepressants, according to new research.
Social anxiety is classified a psychiatric condition characterized by intense fear of social situations that may impede normal daily life.
In the study, scientists at Johns Hopkins Bloomberg School of Public Health collected data from 101 clinical trials involving more than 13,000 people with social anxiety. The researchers examined the effectiveness of various therapies, including various medications and talk therapies, such as cognitive behavioral thearpy (CBT).
The study’s findings, published in the journal The Lancet Psychiatry, showed that CBT was more effective in treating people with social anxiety than were any of the medications. They did not find sufficient evidence that a combination of the two produces better results than either of the treatments alone.
The researchers concluded that CBT should be regarded as a first line of treatment for people with social anxiety disorder. They added that the benefits of talk therapy may also continue after treatment ends, whereas research has shown that many people with social anxiety who take medications get worse when they stop taking the drugs.
Taste genes could affect alcohol use
Genetics may affect how a person tastes and uses alcohol, according to a new study.
Scientists at Penn State University recruited 93 adults and analyzed their genetic make-up. They then asked the volunteers to taste and rate various samples of alcohol.
The researchers were able to identify two specific genetic variations–known as TAS2R13 and RAS2R38–that seemed to affect the study’s participants’ perceptions about the taste of the alcohol. Specifically, the genetic variants affected how bitter a person perceived the alcohol to be. The researchers also found that the more bitter a person perceived the alcohol to be, the less likely they were to drink it, and vice-versa.
The study’s findings, published in Alcoholism: Clinical and Experimental Research, suggest that people with variants of the bitterness gene may drink as much as 50 percent less than those without the genetic variant. In other words, people may be predisposed–or not–to liking alcohol.