Archive for May, 2008


Fetal Alcohol Syndrome a Real Risk of Drinking While Pregnant

In our society, abstaining from alcohol can be difficult, especially during parties and family celebrations. But women who are pregnant or even just trying to get pregnant should stay away from alcohol entirely.

For the woman who is dependent upon or an abuser of this legal drug, it may be impossible to abstain from drinking without first undergoing effective treatment. Pregnant women with alcoholism should join an alcohol abuse rehabilitation program and be checked closely by a health care provider during their entire pregnancy.

Because alcohol use appears to be the most harmful during the first three months of pregnancy, serious harm can occur to the fetus before a woman even knows she is expecting. Few are even aware of the possible consequences of their drinking to the developing child, known as fetal alcohol syndrome (FAS).

Fetal alcohol exposure is the leading known cause of mental retardation in the Western world. In the U.S., FAS occurs as often as or even more frequently than Downs Syndrome or Spinal Bifida. Symptoms of FAS can include the following:

 * Slowed intrauterine growth

 * Poor growth in the fetus and newborn

 * Possible failure to thrive after birth

 * Delayed development and signs of mild-to-moderate mental retardation, with the average IQ in the mid 60s

* Irregularities of the face, including small head and upper jaw; a short, upturned nose; smooth groove in the upper lip; smooth and thin upper lip; narrow, small eyes with large folds above the eye; heart defects; abnormal joints in the hands and feet; tremors in the newborn; agitation and crying

* Abnormalities of the skeleton

Any woman who is pregnant should avoid consuming alcohol throughout her entire pregnancy, as permanent birth defects can occur during each of the trimesters. It is unknown whether the timing or any specific amount of alcohol consumption is safe for the developing baby. Alcohol crosses the placental barrier and can cause physical, mental, and behavioral problems that can persist for a lifetime.

Drinking alcohol during pregnancy can be the first sign of possible fetal alcohol damage. Infant ECG and echocardiogram are able to detect problems such as a heart murmur or other heart structural defects. Ultrasound of the fetus can show delayed intrauterine growth.

The primary effect of FAS is permanent central nervous system damage, especially to the brain. The resulting under-formed or malformed brain structures can create an array of primary cognitive and functional disabilities. Among them are poor memory, attention deficits, impulsive behavior, and poor cause-and-effect reasoning. Since the brain develops during the entire pregnancy, the risk of brain damage exists during each trimester. Mental health problems and drug addiction are secondary disabilities that can manifest themselves later in life and be due to FAS.

Many women are unfamiliar with the potential, permanent consequences of drinking while pregnant. The lifetime medical and social costs of each child born with FAS are estimated as just under a million U.S. dollars. The social costs to the family are inestimable. All women who go off their birth control in order to conceive are advised to drink NO alcohol (and take no harmful drugs). It may be difficult to stop drinking, but it is the best way to give a baby the best possible health and start in life.

Sources:  Wikipedia and other Internet health-related articles     

7 comments May 26th, 2008

How New Drugs and Medical Products are Tested

Whenever a new drug or medical device comes on the market, the process leading up to FDA approval has been costly and time-consuming. Biotech companies spend many years working in their laboratories to develop new drugs to ready them for testing. Companies that can’t afford their own study staffs are increasingly turning to contract research organizations (CROs) to do the testing. Launched by entrepreneurs, an army of CROs is taking on the daunting task of testing for pharmaceutical companies without the time and resources to perform their own.

 In a few cases, these contract firms which have emerged over the past twenty years have not been up to the rigorous task of controlled clinical trials. Mistakes can lead to a product’s delay in being approved, or test subjects may develop unanticipated side effects.  Some bioethicists are urging more regulatory attention for CROs.  The FDA is looking at more stringent regulations of firms conducting clinical trials with human subjects, to hold them fully accountable.

 Stages in the Drug Approval Process:

 Preclinical trials – Testing of a new drug is usually tried first on animals.

 Phase I studies – If laboratory testing of animals shows no harm to them, federal regulators often allow tests on 20 to 80 people, primarily checking for any ill effects.

 Phase II studies – These studies usually involve groups of up to 300 people in order to provide an initial assessment of the drug’s effectiveness.

 Phase III studies – Hundreds to several thousand people are involved in an attempt to determine whether a drug is safe and effective. If it holds up well and shows no unacceptable side effects, the medication has a good chance of approval and subsequent sale.

 Source:  Oakland Tribune; April 25, 2008; business section
 

1 comment May 1st, 2008


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