Calling it a “potential public health disaster,” advisors to the U.S. Food and Drug Administration (FDA) soundly refused to recommend the approval of Merck’s new painkiller Arcoxia, which the company developed to succeed Vioxx, a dangerous drug that was pulled from the market in 2004. (Both Vioxx and Arcoxia are in the same class of drugs, a type of non-steroidal anti-inflammatory drug (NSAID) known as COX-2 inhibitors.) At a meeting today of the FDA’s Arthritis Advisory Committee, the panel voted 20-1 against FDA approval of the drug, although that vote is non-binding and the FDA doesn’t necessarily have to follow the panel’s recommendation.

The fight against Arcoxia (etoricoxib), intended to be used to treat osteoarthritis, was led by Dr. Daniel Graham, an FDA scientist in the Office of Surveillance and Epidemiology, a part of the FDA’s Center for Drug Evaluation and Research (CDER). “What you’re talking about is a potential public health disaster,” Graham said. “We could have a replay of what we had with rofecoxib,” another name for Vioxx.
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White House officials are scrambling to explain the disappearance of email documents related to the controversy surrounding the firings of eight U.S. attorneys. Also at issue is the alleged use of private email accounts by White House staff to conduct governmental business, a practice that is clearly illegal under the Presidential Records Act.

Bush Administration officials have said that more than 20 White House aides including Karl Rove, the president’s chief political advisor have been using private email accounts provided by the Republican National Committee (RNC). Their explanation is that the private accounts were created in order to avoid violating the Hatch Act, which prohibits the use of official government email accounts for “political” work, such as campaigns. However, mounting evidence suggests that the private accounts were often being used for official government business, perhaps in an intentional attempt to circumvent the very oversight that the Presidential Records Act is supposed to ensure.
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New research conducted at the Harvard School of Public Health (HSPH) has determined that there is a strong connection between household firearm ownership and suicide rates. The findings are published in the current issue of the Journal of Trauma.

Simply put, “We found that where there are more guns, there are more suicides,” said Matthew Miller, lead author of the study. According to the research, suicide rates among individuals of all ages and both sexes are higher in states where more households have guns. Although only 5 percent of all suicide attempts use guns, a whopping 90 percent of these acts prove to be fatal. By comparison, 75 percent of all suicide attempts use drugs, but a mere 3 percent of those attempts result in the individual’s death. In short, firearms are far more likely to produce a fatal result in a suicide attempt than any other means, making their very presence a dangerous risk factor. As Miller puts it, “people are less likely to die from attempting suicide when they don’t have access to guns in homes.”
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Canadian pet-food manufacturer Menu Foods has once again expanded its recall of contaminated products after discovering that at least one shipment of tainted wheat gluten made it to its Canadian production facility. In addition, it appears that Menu Foods’ CFO dumped half of his holdings in the company a mere three weeks before they announced the recall.

Last month, Menu Foods recalled more than 60 million cans and pouches of “wet” dog and cat food after the food was linked to kidney failure in a number of pets, but that recall extended only to “cuts and gravy” style dog and cat food manufactured at the company’s Emporia, Kansas, facility between December 3, 2006, and March 6, 2007. However, the company announced yesterday that a shipment of tainted wheat gluten, supplied by ChemNutra, was received at its Streetsville, Ontario, plant and used in the production of pet food in December and January.
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A surprising new study published in the current issue of the Archives of Internal Medicine sought to determine the influence of religion and spirituality on human health. Their conclusion: “Patients are likely to encounter quite different opinions about the relationship between their religion and spirituality and their health, depending on the religious characteristics of their physicians.”

Researchers at the University of Chicago sent a “cross-sectional survey” to a random sampling of 2,000 practicing U.S. physicians from all specialties. The survey asked doctors to estimate how important religion and spirituality issues are to their patients, how much these issues influence health, and how that influence is manifested.
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Following the salmonella-related death of a four-week-old infant in Florida, the U.S. Food and Drug Administration (FDA) is urgently reminding consumers of the health risks posed by pet turtles. According to the agency, “contact with baby turtles can pose a serious health risk to infants, small children, and adults with impaired immune systems as they can be natural hosts to salmonella, a group of bacteria that can cause severe illness and death.”

In the case of the Florida child, the salmonella was indeed traced back to a pet turtle that was living in the house. Salmonella can often be present on both the outer skin and shell surface of turtles, and the bacteria can be spread through direct contact with the animal, contact with its feces, or even contact with the animal’s drinking water.
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The prostate-specific antigen (PSA) screening test has been universally accepted as an important tool in the early diagnosis of prostate cancer. However, a troubling new study published in the current issue of the Journal of the National Cancer Institute calls into question its ultimate benefit, concluding that PSA values and their rates of change are “poor predictors of lethal prostate cancer.”

The study, led by Dr. Katja Fall of the Karolinska Institutet in Stockholm, Sweden, and known as the Scandinavian Prostate Cancer Group Study No. 4, focused on 267 Scandinavian men with localized prostate cancer who were diagnosed between 1989 and 1999 and who were managed by watchful waiting. While certain PSA values and rates of change were indeed associated with lethal prostate cancer, the “accuracy of classifying the disease as either indolent or destined to progress was low,” the authors explain.
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Last week, Pfizer began airing its controversial two-and-a-half-minute commercial promoting the painkiller Celebrex, which is in the same class of drugs as the discredited (and discontinued) Vioxx. For Celebrex, a type of non-steroidal anti-inflammatory drug (NSAID) known as a COX-2 inhibitor, it was a return to television marketing for the first time in more than two years. However, Pfizer may now be forced to pull the ad in the face of mounting criticism that the spot is misleading.

Today, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, sent a letter to Andrew Von Eschenbach, commissioner of the U.S. Food and Drug Administration (FDA), to raise his concerns. Calling the ad “misleading” and “dangerous,” Wolfe wants the FDA to order Pfizer to immediately pull the commercial from the airwaves.
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The U.S. Food and Drug Administration (FDA) announced yesterday that pet-food manufacturer Sunshine Mills Inc. is voluntarily recalling a large supply of its dog biscuits due to fears of contamination. According to the FDA, Sunshine had received a shipment of wheat gluten tainted with the chemical melamine.

The wheat gluten in question was from the same Chinese manufacturer that has been implicated in the recent outbreak of pet illnesses and deaths. Sunshine, which produces both branded and private-label pet food, is recalling a portion of the dog biscuits it manufactured in its Red Bay, Alabama, plant during part of March, 2007.
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President Bush is once again employing his beloved recess-appointment technique to sneak a loyalist into a position of significant power. This time around, Bush has tagged a devout pro-business, anti-regulation, free-market fanatic named Susan Dudley to become the head of the Office of Information and Regulatory Affairs (OIRA). Of course, as a recess appointment, Dudley will not be subject to Senate questioning, approval, or confirmation.

OIRA, which is part of the Office of Management and Budget (OMB), is instrumental in developing regulatory standards and authorizing regulatory policy from the Food and Drug Administration, the Environmental Protection Agency, and the National Highway Traffic Safety Administration, among other groups.
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