Personal Injury Lawyer Blog
Melamine Found in U.S. Baby Formula - Wednesday, November 26, 2008
The Food and Drug Administration has found trace amounts of the industrial chemical melamine in some of the top-selling infant formulas sold in the U.S. The samples of the three top firms – Abbott Laboratories, Mead Johnson, and Nestle – manufacture over 90 percent of all infant formula in the country. However, a top official said parents should not stop feeding this formula to their babies because the levels are extremely low.
This is a change from the beginning of October when the FDA announced that melamine exposure at any level was dangerous to infants, and that they could not set an acceptable level of melamine because scientists have not had enough time to look into how the chemical will affect underdeveloped kidneys of infants. Dr. Stephen Sundlof, Director of the FDA's Center for Food Safety and Applied Nutrition, said this comment may have been misinterpreted, and that the agency didn't mean to imply that domestic infant formula was going to be completely free from melamine.
Melamine exposure has been linked to kidney stones and kidney failure, and has seriously injured and killed infants in China. The FDA said dumping melamine into watered-down milk in China was done intentionally to show higher protein levels, which tricked food quality testing. The concentrations of the melamine in China was as high as 2,500 parts per million. The concentrations found in the U.S. formula were 10,000 smaller, or a drop in a 64 gallon drum.
The formulas the FDA found melamine in include Mead Johnson's Enfamil LIPIL with Iron and Nestle's Good Start Supreme Infant Formula. Though the FDA did not find melamine in Abbott Laboratories' formula, other company tests did find the trace amounts in formula, including Similac brand.
Congressional critics of the FDA say the agency should begin an immediate recall of all formulas that tested positive for any amount of melamine, no matter how small.
Government Continues to Pay for Dangerous Drugs - Monday, November 24, 2008
According to an Associated Press investigation, taxpayers have spent at least $200 million since 2004 for risky drugs used in the Medicaid program. Though the Food and Drug Administration says that unapproved prescription drugs are a public health hazard, and many of these have led to the death of people taking them, they continue to be used. They add that since millions of Americans are taking them, it gives a false sense of security; the rationale being, if so many are taking these drugs, what is the danger?
The AP analysis found that there are more than 100 unapproved drugs still in use through the Medicaid program. However, the FDA says there may be thousands more of these unapproved drugs on the market. And some of them date back to the 1960s before the FDA tightened up its rules to weed many of them out. Most of the medications are for ailments such as the common cold and pain.
The problem has been acknowledged by Medicaid officials, but they say they need Congress to help them. Both the FDA and Medicaid fall under the Health and Human Services Department, but the issues, such as the FDA having trouble to put together a master list of the dangerous drugs, and Medicaid's continuing purchase of these drugs, have complicated matters.
The FDA estimates that unapproved drugs account for almost two percent, or 72 million, of the yearly scripts written, a number that has surprised doctors and pharmacists. Not only is the number high, but also the fact that they are covered by private insurance plans.
The FDA has been investigating on a case by case basis, something its critics claim is not working. Because there is no systematic way to report on these drugs, and there isn't a system where health insurance programs can "validate" the status of these drugs, doctors and pharmacists may not even be aware that these drugs are unapproved.
The problem seems to be bureaucratic in nature: law, regulations, and different governmental agencies with different responsibilities. Add the purpose of Medicaid, to cater to the poor and disabled, which is allowed to pay for unapproved drugs until the FDA orders the drug off the shelf, then everyone begins to blame someone else.
Though the FDA claims that they can't put together a master list of unapproved drugs because manufacturers don't list these drugs with the FDA, AP investigators found plenty of them. These include:
- Carbofed - cold and flu medication
- Hylira - ointment for dry skin
- Andehist - decongestant
- ICAR Prenatal - a vitamin table
While the FDA tells Medicaid when they are going to ban a drug, the different regulatory practices create situations where the drug may be illegal, but it is legal to reimburse for its use. Cracking down on unapproved drugs has been an important priority of the FDA's for the last few years, but there are no federal laws that call for fines for selling dangerous and unapproved drugs, and prosecuting people is almost unheard of.
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