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Tuesday February 9, 2010

Opinion

Top 10 Biggest Medical Stories of 2008

In 2008, the historic election of President Barack Obama and the worsening of the nation’s housing, credit, and financial markets that led to the meltdown of the United States economy dominated news headlines. However, major developments and scandals in the nation’s medical and pharmaceutical industries also made big news during the year. Below are the Top 10 Biggest Medical Stories of 2008.

1) Heparin Overdose and Contamination Scandals

Heparin, a popular blood-thinner made by Baxter International, was the focus of two high-profile scandals. First, it was revealed that the Chinese manufacturing of the drug had substituted a counterfeit active ingredient in the drug that resulted in adverse allergic reactions and other complications in users. A huge recall of Heparin followed, but at least 20 deaths and hundreds of injuries in the United States were blamed on the contaminated active ingredient.

Then, Heparin was the source of several high-profile incidents that involved high doses of the drug being accidentally administered to infants due to confusing labeling. In one case, the twin infants of actor Dennis Quaid and his wife nearly died after a nurse at Cedars-Sinai Medical Center in Los Angeles mistakenly gave the babies massive doses of full-strength Heparin instead of a lower-dosage meant for newborns. Another case of hospital overdoses of Heparin occurred in Texas, when two babies died and more than a dozen were seriously injured after a similar dose mix-up by pharmacy staff and nurses.

2) Digitek Double-Dose Pills Follow Inspection Problems

A nationwide recall of the prescription heart medicine Digitek was announced after the manufacturer discovered that an unknown number of the tablets may have contained a deadly double-dose of the active ingredient, digoxin. About a dozen cases of patient deaths and illness were associated with the double-dose pills before a nationwide recall was instituted.

The double-dose problems for Digitek’s maker, Actavis Totowa LLC, came on the heels of complaints by federal health inspectors, who had detected cleanliness issues and other infractions at a New Jersey manufacturing plant in 2007. The company had been ordered to clean up and improve conditions at the facility.

3) Trasylol Dangers Detailed on “60 Minutes”

The television news magazine “60 Minutes” featured a piece on Trasylol, a drug commonly used to control bleeding during heart bypass surgery that has been linked to an increase in liver failure. In the piece, doctors and researchers said Trasylol doubled the risk of liver failure in people who took the drug and that 22,000 American lives could have been saved if the Food and Drug Administration had pulled Trasylol from pharmacy shelves in 2006, when reports of liver damage from the drug first started surfacing.

Some scientists said Bayer AG, which makes Trasylol, had known about the risks of kidney damage from the drug since the 1980s, but had refused to release internal research detailing the risks to the FDA. The FDA suspended marketing of Trasylol in late 2007.

4) Anti-Smoking Drug Chantix’s Deadly Side Effects

People who took the stop-smoking drug Chantix complained of psychotic, irrational behavior he negative side effects of the anti-smoking drug Chantix caught the attention of federal drug safety officials. Reports of psychotic dreams and irrational, suicidal behavior in people taking Chantix started pouring in after the former guitarist for Edie Brickell and the New Bohemians was shot and killed while trying to break into the house of a friend. The family of Jeffrey Albrecht blamed his bizarre behavior that night on Chantix, which he had started taking to stop smoking just a few months earlier.

5) Botox “Off-Label” Uses Cause Problems

The wrinkle-busting drug Botox was in the news over concerns it was being used in ways the FDA had not approved, including the treatment of cerebral palsy symptoms in young children, some of whom died. Botox has gained international acclaim in recent years for its ability to reduce facial wrinkles, but when used “off label,” the drug has had tragic consequences. Some physicians used Botox, which is a purified form of botulism, to stop muscle rigidity and spasms in cerebral palsy patients, but the powerful drug can migrate inside the body and affect the muscles that control breathing, causing death.

In July 2008, a lawsuit was filed against Allergan Inc., Botox’s maker, on behalf of the families of deceased victims and other victims, alleging the company promoted “off label” uses of Botox, causing injuries and deaths.

6) Dirty Needles Expose Thousands to Hepatitis, HIV

The Endoscopy Center of Nevada was in the news after health officials identified cases of hepatitis C, hepatitis B, and HIV being transmitted to patients due to the reuse of dirty needles. As many as 40,000 patients may have exposed to the diseases in the nearly four years, from 2004 to 2008, as a result of the blood from one patient being spread to others through the re-use of needles.

7) Melamine Found in Chinese Infant Milk, Candies

Scandals involving Chinese-made products have been in the headlines for years, but in 2008, the scandal revolved around dangerous levels of the industrial chemical melamine found in Chinese brands of infant milk, candy, and other consumer products. While no injuries were reported in the United States from the melamine scandal and few of the contaminated products involved were found on store shelves in this country, the contamination caused widespread death and illness in China and put the FDA on alert to make sure no such outbreak occurred in the United States.

8) Salmonella Outbreak in Tomatoes Grips the Nation

One of the nation’s largest outbreaks of the bacteria Salmonella forced restaurants to take certain types of raw tomatoes and other food items off menus out of fear of spreading the contamination. The Salmonella Saint Paul strain was first traced to fresh tomatoes, but the warning was later expanded to fresh Serrano peppers and cilantro. Hundreds people were sickened by food contaminated by Salmonella.

The Salmonella outbreak caused a public relations black eye for the FDA, which seemingly struggled to identify the source of the contamination for months, frustrating consumers unsure of what foods were safe to eat and angering farmers, whose crops were left to rot in the fields or in trucks as officials chased the source of the outbreak.

9) Effects of Controversial Plastic Additive Debated

Bisphenol-A, a controversial chemical that is used to make clear plastic baby bottles and other products shatterproof, stayed in the news in 2008, when a group of scientists accused the FDA of ignoring evidence that the chemical can be dangerous. For years, consumer groups have complained that not enough is being done to learn about the potential dangers of the chemical, which has been linked to developmental problems in young children.

10) Supreme Court Restricts Lawsuits on Defective Medical Devices

In March, 2008 the United States Supreme Court ruled that under most circumstances patients injured by defective medical devices cannot file state tort claims against the manufacturer. The lawsuit, Riegel v. Medtronic, was filed after a Medtronic-made heart catheter burst and left the patient severely disabled. The Supreme Court ruled in favor of Medtronic, sending shockwaves through the consumer rights’ movement and threatened to leave injured patients without a way to seek damages for injuries caused by dangerous devices.

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