Oversulfated Chondroitin Sulfate in heparin has been shown to cause side effects in pigs similar to those seen in patients treated with the tainted drug, according to an article in the “New England Journal of Medicine”. The study is the first one to show a direct link between the counterfeit ingredient and the hundreds of serious, and sometimes fatal reactions, reported over the last several months in patients treated with heparin.

The New England Journal of Medicine study, led by researchers at MIT,  found that the chondroitin sulfate activates two inflammatory pathways: one that initiates blood clotting and dilation of the blood vessels, and one that produces anaphylactic toxins. The first leads to a dangerous decrease in blood pressure, the second a serious allergic reaction. In blinded laboratory tests, the contaminated heparin activated the biological pathways, while normal heparin did not. (more…)

The Consumer Products Safety Commission (CPSC) has levied $320,000 in fines against eight farms for failing to report that children’s clothing they sold had dangerous drawstrings. Federal law requires manufacturers, distributors, and retailers to report dangerous products to the CPSC within 24 hours after learning that a product contains a defect which could create a substantial risk of injury to the public, presents an unreasonable risk of serious injury or death, or violates a federal safety standards. The eight companies that have agreed to the fine are:

• Life is Good Inc.
• True Religion Apparel Inc.
• The Cayre Group Ltd.
• DollarDays International, LLC
• Kohl’s Department Stores Inc.
• Seena International Inc.
• Neiman Marcus Group Inc
• Gildan Activewear SRL

Despite the fine, the CPSC said that none of the eight firms have admitted any wrongdoing. (more…)

A woman who blames Accutane for the ulcerative colitis that caused her to have her colon removed has been awarded $10.5 million in an Accutane lawsuit. The lawsuit, filed by a personal injury law firm in New Jersey, was the third Accutane case involving inflammatory bowel disease to come to trial, all of which have resulted in favorable verdicts for Accutane paintiffs. Hoffman-LaRoche, the maker of Accutane, has said it will appeal all of the verdicts, and insisted that the link between Accutane and inflammatory bowel disease has not yet been proven. In a statement, the company also said that “the Accutane labeling has contained a warning about IBD for more than 20 years.”

According to the Wall Street Journal, Kamie Kendall, a 24-year-old Utah hairdresser, started taking Accutane at age 12. She was diagnosed with ulcerative colitis at the age of 14, and in 2006 she had her colon removed and now suffers from debilitating diarrhea. The jury awarded Kendall $10.5 million of compensatory damages plus $78,500 for medical expenses. The judge presiding over the case ruled there was insufficient evidence to allow the jury to consider punitive damages or consumer fraud. (more…)

The Chinese, trying to prove that their country’s manufacturing was not responsible for the tainted heparin that has killed 81 people in the US, finished an inspection of Baxter International’s New Jersey plant that finished processing heparin from raw ingredients imported from China. The Chinese recently insisted that a counterfeit ingredient that likely came from China was not responsible for the reactions seen in the US, and claim that problems with heparin probably originated in this country.

So far, the Chinese are not commenting on what they may have found from their inspection of Baxter’s plant, which concluded yesterday. But at a news conference announcing the inspection earlier this week, a Chinese official disputed that the heparin problems occurred in that country. Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, said that Chinese investigators tested batches of heparin used by patients who reported health problems, and only some contained chondroitin sulfate. He also said that heparin with the contaminant has been found in many nations, but that none has reported a similar spike in harmful reactions as in the United States. Shaohong also said Chinese officials are focusing on the whole product, and speculated that other contaminants, problems with the device used to inject the heparin, or health factors with the patients who used the drug could also be causing the reactions. (more…)

Wisconsin based Scientific Protein Laboratories has received a warning letter from the Food & Drug Administration (FDA) for its role in the tainted heparin debacle. Scientific Protein Laboratories owns the Chinese factory that provided Baxter International with raw ingredients for now-recalled heparin. According to the FDA warning letter, conditions at the plant where “unsuitable”.

Baxter heparin made with ingredients manufactured at Scientific Protein Laboratories’ Changzhou, China plant were contaminated with a counterfeit ingredient, and have been implicated in 81 deaths in the US, as well as hundreds of adverse reactions. In March, the FDA confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Scientific Protein Laboratories. It costs a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs. Last week, FDA Commissioner Andrew von Eschenbach said that while the FDA has no specific evidence that the chondroitin sulfate contamination was intentional, “the concern is that it had to be by design.” (more…)

Pfizer is in trouble with the Food & Drug Administration (FDA) for a Viagra ad that did not include information about the drug’s serious side effects, prompting the agency to send the drug maker a warning letter.

Apparently, a Viagra ad run on CNN.com made no mention of the hearing or vision loss that can occur when taking the drug, nor did it warn that men taking nitrates should not use Viagra. In a letter to Pfizer dated April 16, the FDA said “The video raises public health and safety concerns through its complete omission of risk information for Viagra by suggesting that Viagra is safer than has been demonstrated.” (more…)

Tainted heparin has now been implicated in the deaths of 81 U.S. patients, and the Food & Drug Administration (FDA) says it now has made a direct connections between some adverse heparin reactions and the counterfeit ingredient found in some batches of the the drug sourced from China. Now, officials from the U.S. and China are at odds, with each blaming the other country’s manufacturing for problems with the drug. The Chinese are insisting their manufacturing is not to blame for the problems, and claim the defective heparin may have actually originated in the U.S.

According to The New York Times, the FDA has identified 12 Chinese companies that have supplied contaminated heparin to 11 countries — Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States. The FDA has not determined the original source of all the contamination or the points in the supply chain at which it was added. The Times also said officials have discovered heparin lots that included the cheap fake additive manufactured as early as early as 2006, although a spike in illnesses associated with contaminated heparin began in November and persisted through February. (more…)

The concerns over the chemical bisphenol A—BPA have prompted one maker of plastic bottles to announce a phase-out of bottles made with the potentially-toxic chemical. BPA is a fairly ubiquitous chemical used in polycarbonate plastic products, including baby bottles and metal can coatings that could be linked to a range of hormonal problems, according to a recent and preliminary government report developed by a group of scientists from the Centers for Disease Control (CDC), the Food and Drug Administration (FDA), and the Institutes of Health (NIH).

The federal National Toxicology Program said experiments on rats found precancerous tumors, urinary tract problems, and early puberty when animals were fed or injected with low doses of BPA. With over six million pounds produced in the United States each year, BPA is found in dental sealants, the liners of food cans, CDs and DVDs, eyeglasses, and hundreds of household goods. Over 90 percent of Americans are exposed to trace amounts of BPA, according to the CDC and last month said animal testing revealed BPA has hormone-like effects on the reproductive system. (more…)

A Chinese governmental official is disputing the notion that a counterfeit ingredient found in batches of recalled heparin has caused serious reactions and deaths among U.S. patients treated with the drug. Last month, the Food & Drug Administration (FDA) said it had found the chemical in some heparin recalled by Baxter International, but has not yet determined if hundreds of reactions and possibly dozens of deaths are linked to the contaminant.

Whatever the cause, the heparin problems once again placed Chinese manufacturing in bad light. But Jin Shaohong, deputy director-general of the China National Institute for the Control of Pharmaceutical and Biological Products, insisted a news conference this morning that Chinese manufacturing was not at fault, and that the heparin problems may well have originated in the U.S. To that end, Shaohong said his country would be sending its own investigators to examine the New Jersey plant where Baxter finished processing its heparin. Shaohong said that Chinese investigators tested batches of heparin used by patients who reported health problems, and only some contained chondroitin sulfate. “The oversulfated chondroitin can therefore not be the suspected root cause of heparin ADE (adverse events),” he told reporters at a news conference this morning. (more…)

More and more drug makers are hiring Contract Research Organizations (CROs) to conduct clinical trials of new drugs. In fact, one of every five dollars biomedical firms spend on research and development goes to outside experts – particularly CROs, which number at least 700 in North America and Europe. Yet ins spite of the vital role clinical trials play in determining drugs safety and effectiveness, little is being done to police these organizations.

Drug makers like CROs because these companies are able to conduct studies quickly, in part because many of them maintain worldwide networks of researchers who can participate on short notice. But according to the “San Jose Mercury News”, the Food & Drug Administration (FDA) inspected just 1 percent of the estimated 350,000 sites where studies involving human subjects were done during the 2000 to 2005 fiscal years. Moreover, an increasing number of such studies are being done in foreign countries, where the FDA has limited authority. That means the pharmaceutical companies must be counted on to oversee the CROs they hire, but no one knows if they are doing this adequately. (more…)