Thalidomide and Congenital Abnormalities - Thornlea

THALIDOMIDE AND CONGENITAL ABNORMALITIESThe Lancet, to alert the medical community to thedangers of thalidomide.nPRIMARY SOURCETHALIDOMIDE AND CONGENITAL ABNORMALITIESSIR,—Congenital abnormalities are present in approximately15% of babies. In recent months I have observedthat the incidence of multiple severe abnormalities inbabies delivered of women who were given the drug thalidomide(‘Distaval’) during pregnancy, as an anti-emetic oras a sedative, to be almost 20%.These abnormalities are present in structures developedfrom mesenchyme—i.e., the bones and musculatureof the gut. Bony development seems to be affected in avery striking manner, resulting in polydactyly, syndactyly,and failure of development of long bones (abnormally shortfemora and radii).Have any of your readers seen similar abnormalities inbabies delivered of women who have taken this drug duringpregnancy?Hurstville, New South Wales.W. G. MCBRIDE.nnnA young thalidomide victim, born without arms, clutches abouquet with her toes as she presents it to Princess Anne ofGreat Britain in 1972. ªBETTMANN/CORBIS.SIGNIFICANCEMcBride’s warning concerning the teratogeniceffects of thalidomide saved countless babies frombeing born with birth defects. However, the drugremained on the market for some time followingMcBride’s warning, which accounts for the fact thatthere are still some 8,000 thalidomide survivors in theworld today.The observations of McBride and Lenz were tohave far-reaching effects on the pharmaceutical industry.They were astute enough to notice rare and unusualconditions occurring in their patients and to spotpatterns and connections with factors such as drugexposure. After thalidomide, it became mandatory totest new drugs on pregnant animals. Doctors becamefar more aware of the potential teratogenic effect ofdrugs and were more careful about the drugs theyprescribed to pregnant women.In general, the drug regulatory authoritiesacquired more sweeping powers after the thalidomidetragedy. One important development was the establishmentof systems for post-market drug surveillance.That is, once a drug is on the market, it is monitoredfor any new side effects that emerge in the generalpopulation. These new side effects are reportedthrough the physician. As a result of these postmarketingsurveillance efforts, several drugs havebeen withdrawn on safety grounds. Unanticipateddrug side effects still occur and they still harm oreven kill vulnerable people. However, tighter regulationhas undoubtedly improved patient safety.Meanwhile, thalidomide has enjoyed somethingof a resurgence as a treatment for leprosy and multiplemyeloma. However, it is no longer prescribed towomen who are pregnant or who may become pregnant.Scientists now know that other drugs are asdangerous to an unborn child as thalidomide is. Onesuch drug is isotretinoin, which is used in the treatmentof severe acne. A woman actually needs to provideproof of a negative pregnancy test before she canbe prescribed isotretinoin, according to the U.S.Food and Drug Administration. While on the drug,she must use an effective method of contraception.The fetus is most vulnerable to medication exposurethrough the placenta in the first three months ofpregnancy. In the thalidomide case, one in fivewomen who had taken the drug between thirtysevenand fifty-four days of pregnancy gave birth toa child with birth defects.292 MEDICINE, HEALTH, AND BIOETHICS: ESSENTIAL PRIMARY SOURCES

FAMINE AND PUBLIC HEALTHFURTHER RESOURCESBooksLock, Stephen, John M. Last, and George Dunea, eds. TheOxford Illustrated Companion to Medicine. Oxford: OxfordUniversity Press, 2001.Web sitesJames Lind Library.org. ‘‘Thalidomide: An UnexpectedAdverse Effect.’’ (accessed November 21,2005.Famine and Public HealthPictureBy: DempsterDate: January 21, 1970INTRODUCTIONFamine is the extreme lack of food and nutrients,often resulting in widespread disease and death. Aparticularly large number of famines occurred duringthe 1900s, and into the twenty-first century, despitethe world’s extensive social, economic, and technicaladvances during the same time period. Althoughefforts have been made to combat and prevent famines,food shortages around the globe, due to such factors aswar, drought, and ill-focused political decisions, continueto take a toll on the lives of some of the world’smost impoverished inhabitants.Acute hunger can cause people to die of starvationdirectly, but there are many more individuals who maysurvive famine, only to be faced with the health problemsthat often accompany undernourishment andvitamin and mineral deficiencies. Common effects ofmalnutrition include stunted growth, weakness, andsusceptibility to disease. People who are malnourishedoften have poor concentration, which exacerbates theproblem of hunger, as it is difficult for hungry peopleto work in fields, or earn money for buying food.Pregnant women, those who are breast-feeding newborns,and children are the most vulnerable to hungerrelated problems. Over 150 million children, worldwide,below the age of five, are said to be underweight.Eleven million children under the age of five die eachyear, with over half of the deaths directly related tomalnutrition. Typically these children do not die fromstarvation itself, but rather from the diseases that strikea weak and vulnerable body, whose immune system islikely unable to put up a defense. The four most commonchildhood illnesses in developing countries arediarrhea, respiratory illness, malaria, and measles.All parts of the globe are known to have experiencedfamine. The blockade of German trade ships byBritain and France, along with a harsh winter in 1916–1917, left several hundred thousand Germans deadprior to the start of World War I. Five to eight millionpeople in Ukraine died from famine during the 1930s,when the Soviet Union seized agriculture outputs inhopes of exporting more food to bring in money forindustrialization. The Chinese famine between 1958–1962 is considered one of the worst in history, withestimates of up to thirty million people dying asChina’s leader, Mao Ze-dong, implemented a plan ofrapid industrialization in rural areas.Famines occurring in Africa have received the mostextensive international publicity. During Nigeria’s civilwar with Biafra between 1968–1970, at least one millioncivilians died from hunger and fighting. The worldwas shocked by photographs of starving children withdistended stomachs caused by protein deficiency.Between 1984–1985, drought throughout Ethiopiaimpacted 120 million people, with scenes of starvationseen on television sets throughout the western world.Fundraising events all over the world led to the arrivalof some emergency food aid to Ethiopia, but bottlenecksat the ports, and poor quality roads slowed downrelief efforts. Throughout the 1990s and into thetwenty-first century, civil war between the Arab andblack Sudanese have led to food crises, particularly inthe Darfur region of Sudan, where 3.4 million, or halfof the region’s population have been forced from theirhomes and farmlands. Throughout various regions ofAfrica, ongoing political unrest, unreliable rainfall, andpoverty keep millions of people at risk of hunger.nPRIMARY SOURCEFAMINE AND PUBLIC HEALTHSee primary source image.nnnSIGNIFICANCEThe United Nations (UN) classifies 1.2 billionpeople below the international poverty line, living onless than one dollar per day. Many of these peopleexperience regular food shortages, while others arejust barely able to meet their daily food requirements.All families under the poverty line are vulnerable toshocks such as droughts, earthquakes, and wars, allMEDICINE, HEALTH, AND BIOETHICS: ESSENTIAL PRIMARY SOURCES 293