Clinical Drug Trials Aren’t Representative of America; This Group Wants to Change That

Advocates say clinical trials are not representative of the racial makeup of the United States, which could mean that treatments approved by the Food and Drug Administration will have unforeseen complications on certain demographics. A national push begun this week is aiming to change that by increasing diversity in the trials. Full Story

The FDA Just Approved a New Hepatitis-C Drug. The Price? $84,000 a Treatment.

The Food and Drug Administration last week approved a pill that is expected to make the treatment of hepatitis C easier, shorter, and more effective. Great, right? There is a downside, though: it costs $1,000 a day. The drug, Sovaldi, will allow some patients infected with the liver-destroying virus to be treated with pills only, doing away with weekly injections of a drug that is usually accompanied by debilitating side effects. That treatment can take up to a year and only cures about three out of four patients. Sovaldi is a daily pill that—in clinical trials—cured close to 90 percent of… Full Story

Texas Pharmacy Linked to Bacterial Outbreak

State officials have connected a Central Texas compounding pharmacy to a bacterial outbreak that sickened 17 patients in Corpus Christi hospitals earlier this year, the Associated Press reported. Officials said the most recent results showed a “genetic match” between the bacteria found in the product and bacteria in blood samples of 15 of the patients. The investigation continues and authorities have not concluded that Cedar Park-based Specialty Compounding is to blame for the illnesses. In September, an inspector—hired by Speciality Compounding—found no link to the infection, which has killed two patients.

Dallas Company Draws FDA Investigation After Product Linked to Hepatitis Deaths

Food and Drug Administration investigations have become second nature for Dallas-based USP Labs, after a recent look by the federal agency linked one of the company’s supplements to a hepatitis outbreak in Hawaii. The FDA issued a warning last week linking the company’s bodybuilding supplement OxyElite Pro to an outbreak of non-viral hepatitis. Nearly 30 patients have been hospitalized with acute heptatitis so far, two dozen of whom had used OxyElite Pro. Two of those have required liver transplants, and one has died. “The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient… Full Story