› $4.85 Billion settlement in drug case
A recent Time magazine story gives us a glimpse into a family affected by the contaminated heparin tragedy: Leroy Hubley’s wife of 48 years, Bonnie, suffered from polycystic kidney disease, a genetic kidney disease in which cysts grow in the kidneys, causing them to fail. She received a kidney transplant in October 2007, but her body rejected it, leaving her in need of regular dialysis treatments.
Heparin remains in high demand in the United States, with more than 300,000 doses used daily. The blood thinner, which has been widely used since the 1930s, saves lives by preventing potentially fatal blood clots and reducing the amount of time patients with kidney failure stay on dialysis machines. However, controversy surrounds the medication and companies are quickly working on alternatives.
People who have high cholesterol may have another alternative to statin drugs – a method that literally sucks bad cholesterol right out of a patient’s blood, according to the St. Louis Post-Dispatch.
The U.S. Food and Drug Administration (FDA) is at odds with congressional investigators over an investigation into the federal agency’s inspection of foreign drug manufacturing facilities.
Will Chinese products be responsible for more deaths and hardships around the world?
Early last year, more than 80 people died and thousands more were sickened after receiving the blood thinner heparin. It was later found that specific lots had been contaminated at a manufacturing plant in China.
Despite heparin-recall woes earlier in the year, Pharmaceutical drug giant Baxter International announced that it had a 19 percent increase in third-quarter profits, according to a Baxter International press release.
Five pharmaceutical companies are working on new medications to treat blood clots, also known as thrombosis, according to The Wall Street Journal. Thrombosis is a serious problem affecting nearly 900,000 Americans each year, and resulting in nearly 300,00 deaths annually. Currently, heparin and Vitamin K antagonists are the only two principal treatments for blood clots.
The U.S. Food and Drug Administration (FDA) will place more than 60 food and drug regulators worldwide over the next year to provide guidance on U.S. quality standards, according to the Associated Press. This will replace the agency’s current practice of sending staffers on individual assignments to inspect foreign facilities.
There has been yet another report of heparin being pulled off the market for fear it may harm people. This week, French drug maker Sanofi-Aventis recalled the remaining batches of its heparin medicine distributed before May 2008, Lovenox, based on a recommendation by French drug regulator Afssaps.
Heparin isn’t the only China-made product that has turned up contaminated and, in many cases, harmed others. Last March, a contaminant was found in batches of Heparin, supplied to Baxter International by its Chinese plant. The over-sulfated chondrotin sulfate in the heparin is blamed for causing more than 80 deaths and breathing problems in another 700 in the United States.
