From washingtonpost.com

A congressional subcommittee wants to subpoena criminal investigators at the Food and Drug Administration about their own probe concerning the antibiotic Ketek, which has been linked to liver failure.

For months, subcommittee leaders have alleged that the FDA approved Ketek even though the agency knew the large safety study it required before approval was fraught with data problems. A vote on issuing the subpoenas is scheduled for Tuesday.

Ketek was approved in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. After receiving reports of liver failure in patients treated with the drugs, the FDA last February issued a black box warning _ its sternest _ and restricted use to patients with pneumonia.

The subpoenas are needed to compel the testimony of Ann Marie Cisneros, a clinical researcher who found fraudulent data in a Ketek study, two current FDA investigators, Robert West and Douglas Loveland, and one former investigator, Robert Ekey, said Reps. John Dingell and Bart Stupak, both Michigan Democrats.

Dingell chairs the House Energy and Commerce Committee, and Stupak is chairman of the Subcommittee on Oversight and Investigations.

The subcommittee will also consider issuing a subpoena for internal FDA documents connected with the investigators’ work. Congressional aides were told the documents summarize the FDA’s investigation of whether Sanofi-Aventis was aware of problems with one of its safety studies before it was submitted to an advisory committee. The document “may recommend prosecution of certain individual and/or entities for the fraudulent trials,” the memo states.

The maker of Ketek, Sanofi-Aventis SA, acknowledges on its Web site that one of the studies used to support approval of the drug was marred by fraud. However, it said, Aventis did not become aware of the fraud until after the study was submitted to the FDA. The agency has also said there was no intention to deceive the public. It did not know at that time that the entire study should not be relied upon.

The subcommittee is investigating whether the agency has taken adequate steps to protect the public from excessive risks from prescription drugs already on the market. Stupak has cited problems with pain relievers Vioxx and Bextra as examples of regulatory failure by the FDA, and has aggressively investigated the approval of Ketek over the past year. He’s also seeking to subpoena the briefing book for Commissioner Andrew C. von Eschenbach to determine whether he was misled in the preparation of his testimony dealing with Ketek.

From sciencedaily.com

Parkinson’s disease, the most common neurodegenerative movement disorder caused by aging, can also be caused by pesticides and other neurotoxins. A new study found strong evidence that trichloroethylene (TCE) is a risk factor for parkinsonism, a group of nervous disorders with symptoms similar to Parkinson’s disease.

TCE is a chemical widely used in industry that is also found in drinking water, surface water and soil due to runoff from manufacturing sites where it is used.

Led by Don M. Gash and John T Slevin, of the University of Kentucky in Lexington, KY, researchers conducting a clinical trial of 10 Parkinson’s disease patients came across a patient who described long-term exposure to TCE, which he suspected to be a risk factor in his disease. TCE has been identified as an environmental contaminant in almost 60 percent of the Superfund priority sites listed by the Environmental Protection Agency and there has been increasing concern about its long term effects.

The patient noted that some of his co-workers had also developed Parkinson’s disease, which led to the current study of this patient and two of his co-workers diagnosed with Parkinson’s disease who underwent neurological evaluations to assess motor function. All of these individuals had at least a 25 year history of occupational exposure to TCE, which included both inhalation and exposure to it from submerging their unprotected arms and forearms in a TCE vat or touching parts that had been cleaned in it.

In addition, questionnaires about experiencing signs of Parkinson’s disease, such as slowness of voluntary movement, stooped posture and trouble with balance, were mailed to 134 former workers. The researchers also conducted studies in rats to determine how TCE affects the brain.

The results showed that 14 former employees who reported three or more parkinsonian signs worked close to the TCE source, were found to exhibit signs of parkinsonism when they were examined and were significantly (up to 250 percent) slower in fine motor hand movements than age-matched controls. Clinical exams of 13 patients who reported no signs of parkinsonism revealed that they worked in the same areas as the symptomatic workers or further from the TCE vat, they exhibited some mild features of the condition and their fine motor movements were also significantly slower than controls, although they were faster than the group with symptoms.

The rat studies showed that TCE exposure inhibited mitochondrial function (which in humans is associated with a wide range of degenerative diseases) in the substantia nigra, an area in the brain that produces dopamine and whose destruction is associated with Parkinson’s disease. Specifically, Complex 1, an enzyme important in energy production, was significantly reduced in the substantia nigra. Dopamine neurons in this area also showed degenerative changes following TCE administration.

The authors acknowledge that while the study was not a large scale epidemiological investigation, the results demonstrate a strong potential link between chronic TCE exposure and parkinsonism. “It will be important to follow the progression of movement disorders in this cohort over the next decade to fully assess the long-term health risks from trichloroethylene exposure,” they state. Although previous studies identified pesticides as a risk factor for Parkinson’s disease, the drug MPTP was previously the only mitochrondrial neurotoxin linked to the disease.

The authors conclude: “Trichloroethylene is implicated as a principal risk factor for parkinsonism based on its dopaminergic neurotoxicity in animal models, the high levels of chronic dermal and inhalation exposure to trichloroethylene by the three workers with Parkinson’s disease, the motor slowing and clinical manifestations of parkinsonism in co-workers clustered around the trichloroethylene source, and the mounting evidence of neurotoxic effects in other reports of chronic trichloroethylene exposure.”

Journal article: “Trichloroethylene: Parkinsonism and Complex 1 Mitochondrial Neurotoxicity,” Don M. Gash, Kathryn Rutland, Naomi L. Hudson, Patrick G. Sullivan, Guoying Bing, Wayne A. Cass, Jignesh D. Pandya, Mei Liu, Dong-Yong Choi, Randy L. Hunter, Greg A. Gerhardt, Charlie D. Smith, John T. Slevin, T. Scott Prince, Annals of Neurology, December 2007.

From WebMD

A class action lawsuit has been filed against the yogurt company Dannon over its marketing for yogurt products Activia and DanActive.

Activia is a yogurt marketed as being “clinically proven to help regulate the digestive system when eaten daily for two weeks,” according toActivia’s web site.

DanActive is a drink marketed as being “clinically proven to help strengthen the body’s defense systems,” states DanActive’s web site.

Those claims focus on probiotics, which are healthy gut bacteria. There are many strains of probiotics; Activia and DanActive tout trademarked probiotic strains.

The lawsuit alleges a “massively deceptive” advertising campaign about those products’ “clinically” and “scientifically” proven health benefits not available in other yogurts, states a news release from Coughlin Stoia Geller Rudman & Robbins LLP, the San Diego law firm that filed the lawsuit earlier this week.

Dannon countered with its own news release, in which Dannon says it “vigorously challenges this lawsuit” and “proudly stands by the claims of its products and the clinical studies which support them.”

Nutritionists’ Views

“Does this make yogurt a bad thing? No. If people want to eat yogurt, by all means, they should because you’re getting nutrients in yogurt that you’re not going to get in a pill,” Leslie Bonci, MPH, RD, director of sports nutrition at the University of Pittsburgh Medical Center, tells WebMD.

WebMD Director of Nutrition Kathleen Zelman, MPH, RD, LD, agrees.

“Yogurt is good for you,” Zelman says. She suggests that people who buy yogurt look for products that contain “live and active cultures or are enriched with additional healthy bacteria because there’s sound science to document the healthfulness of those products.”

But Bonci and Zelman say consumers shouldn’t expect any yogurt to cure digestive disorders by itself.

Everybody probably won’t find all their digestive problems solved by eating specialized yogurt products for two weeks, and “that may not be the yogurt’s fault,”Bonci says. “What else are they doing in their diet?

“I think if people are looking to maximize their digestive health, it’s probably going to take more than a container of something that’s in your refrigerator,” she says.

Consuming enough fluids and fiber, being physically active, and controlling stress are also important for good digestive health, Bonci says.

From WebMD

- Chronic fatigue syndrome may be linked to the stress hormone cortisol, at least in women, according to a new study.

The study shows that women with chronic fatigue syndrome had lower cortisol levels in the morning, compared with healthy women.

The study included 185 Georgia adults, 75 of whom had chronic fatigue syndrome. Those patients had fatigue lasting at least six months with no known cause and accompanied by at least four other symptoms, such as muscle pain or memory problems.

Participants provided saliva samples taken as soon as they woke up, and again 30 minutes and an hour later. The CDC’s William Reeves, MD, and colleagues measured cortisol levels in the saliva samples.

Chronic fatigue syndrome was associated with lower morning cortisol levels among women, but not among men. Morning cortisol levels were similar for men with and without chronic fatigue syndrome.

The study doesn’t prove that low morning levels of cortisol cause women’s chronic fatigue syndrome. The researchers don’t know which came first — low morning cortisol levels or chronic fatigue syndrome — but their findings may be a clue for researchers

From New York Times

Breast cancer patients who had reconstructive surgery using implants immediately after mastectomies were twice as likely to acquire infections as women who immediately had breast reconstruction using their own tissue, according to a study published yesterday.

The article in Archives of Surgery, which examined the medical records of breast surgery patients at Barnes-Jewish Hospital in St. Louis from mid-1999 to mid-2002, found that 50 of 949 patients acquired an infection at the surgical site within a year after surgery.

Roughly 12 percent of the infections occurred in mastectomy patients who immediately had implant surgery, compared with roughly 6 percent of infections in those who immediately had breast reconstruction using their own abdominal tissue, the study said. In noncancer patients, about 1 percent of infections occurred after breast reductions and no infections occurred after breast augmentation using implants, the study said.

The bottom line is that implants are associated with an increased risk of infection in breast cancer patients, said Margaret A. Olsen, the lead author of the study and a research assistant professor of medicine at Washington University School of Medicine in St. Louis. The question is what factors contribute to this increased risk and what can be done to prevent it?

The study noted whether patients had other medical conditions like diabetes, but it did not report how many underwent radiation or other treatments that might have played a role in the infections.

The study did analyze the cost to the medical center of each infection

about $4,100 per patient

a hospital-acquired complication not covered by managed care, she said.

But both kinds of reconstructive surgery entail risk.

Dr. Stephen R. Colen, the chairman of plastic and reconstructive surgery at Hackensack University Medical Center in New Jersey, said operations using abdominal tissue took several hours longer than implant surgery, increasing the risk of blood clots and lung embolisms. In 2 percent of patients, the transplanted tissue dies, requiring further surgery, Dr. Colen said.

But implant reconstruction inserts a foreign object into the body, providing a surface on which bacteria may grow. And implantation involves a series of procedures

including one surgery to insert a skin-stretching device in the chest, followed by saline injections to expand the breast, another surgery to put in a permanent implant and a final surgery to attach a nipple

creating more occasions for infection to occur, Dr. Colen said.

Dr. Keith E. Brandt, a professor of plastic and reconstructive surgery at Washington University and an author of the study, said all patients received prophylactic antibiotics at the time of surgery. But postsurgical treatments for breast cancer, like radiation, may weaken the bodys ability to fight infection.