FDA against Raw Milk, they want DEAD FOOD, no enzymes

Special FDA agents and investigators from the U.S. Food and Drug Administration aggressively interrogated two young female employees of Organic Pastures Dairy Company, the nation's largest raw milk producer, with questions focusing on the dairy's interstate sales of raw colostrum and raw milk for pet food.

The surprise interrogations took place after work in their private homes on the evening of March 19, just hours after Judge Tobias of the Hollister Superior Court issued a temporary restraining order against the California Department of Food and Agriculture. The state court ruling blocked enforcement of California's anti-raw milk AB 1735, which mandates unnecessarily stringent standards for beneficial coliform bacteria in raw milk. The temporary restraining order represents an important legal victory for raw milk producers and consumers in California and throughout the nation.

The federal agents threatened one employee with arrest if questions were not fully and truthfully answered about Organic Pastures' order fulfillment practices. Her answers reflected information that is readily available at the company's website, www.organicpastures.com. The other employee was told FDA would "make it worth her while" to "wear a wire" and record conversations with Organic Pastures president Mark McAfee. The employee refused the offer. "We are like a family, I would never do that to a family member," she said, reflecting her close relationship with the McAfee family.

Both employees were served subpoenas to appear April 3 for a secret grand jury investigation. In 2003, Organic Pastures received a confirmation letter from Larry Childers of the FDA, which clearly stated that interstate sales of raw colostrum are not regulated because colostrum is not milk. The FDA website notes that "pet food" requires no pre-market approval and is unregulated by the FDA.

The Bronx Zoo in New York and other zoos regularly order raw colostrum and raw dairy products from Organic Pastures to save babies of endangered species and keep other animals healthy. Orders stipulate that the milk and colostrum must be raw because pasteurized versions make them ill. Many veterinarians recommend raw milk for cats and dogs.

"FDA has gone on the record as 'hating raw milk' in any form," says Mark McAfee, founder and president of Organic Pastures. "The harassment of our employees and grand jury investigation is just the latest round in the government vendetta against Nature's perfect food. If Organic Pastures is doing something illegal, all FDA needs to do is come and tell us and we will make the necessary changes to our labels and procedures."

Organic Pastures will be represented in this action by the Farm-to-Consumer Legal Defense Fund. Membership in the Fund helps support the defense of raw milk and direct farm-to-consumer sales. For further information visit www.ftcldf.org.

FDA Tries to Justify High Levels of Contaminants in Infant Formula

The FDA has admitted that it based its determination that current levels of bisphenol-A (BPA) exposure pose no health risks on two studies sponsored by the American Plastics Council, the trade group that represents BPA manufacturers.

One of these studies has been found to be deeply flawed, and the other study has not been published and its results have not been made public. The FDA chose to ignore data from almost 100 independent, peer-reviewed, and published animal studies that show that BPA is toxic at very low levels of exposure. Many of these independent studies were funded by the National Institutes of Health.

BPA is used in a number of different plastic products, including baby bottles.

FDA Quietly Acknowledges the Medical Benefits of Honey

The U.S. FDA has quietly approved a line of honey-based wound dressings. Although using honey to treat wounds is nothing new, it is a practice often relegated to "folk healing".

In fact, honey has antibacterial properties, and it produces its own hydrogen peroxide when combined with the fluid which drains from a wound. It also draws the pus and fluid from the wound, speeding the healing process.

Honey has been accepted by the overseas mainstream medical community for some time, and it looks like the U.S. has finally caught on.

The FDA has agreed to put Merck’s application for expanded approval of Gardasil

The FDA has agreed to put Merck’s application for expanded approval of Gardasil, a cervical cancer vaccine, on the fast track. It is already approved for women and girls ages 9 through 26, and the expansion would allow it for use in women ages 27 through 45.

The FDA’s decision has disturbed many people who are concerned over the high number of side effects reported in relationship to Gardasil. A 2007 analysis revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil.

Gardasil side effect reports include blood clots, miscarriages, paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. Despite this, Merck continues to market Gardasil as virtually side-effect free, and the FDA has thus far refused to conduct a formal safety review of Gardasil.

How Drug Companies Covertly Influence the Content of Medical Literature

April 16, 2008 by: David Gutierrez
Pharmaceutical companies regularly carry out every aspect of a study on their products, then solicit academics to put their names on the final papers in order to disguise their involvement, according to an essay published in the journal PLoS Medicine. Author Sergio Sismondo calls this practice "ghost management," to distinguish it from mere ghost writing.

"In extreme cases, drug companies pay for trials by contract research organizations (CROs), analyze the data in-house, have professionals write manuscripts, ask academics to serve as authors of those manuscripts, and pay communication companies to shepherd them through publication in the best journals," Sismondo writes. "The resulting articles affect the conclusions found in the medical literature, and are used in promoting drugs to doctors."

Sismondo points to a study conducted by David Healy and Dinah Cattell, who analyzed Pfizer's involvement in managing studies on its product Sertraline. The researchers uncovered that through a CRO, Pfizer was keeping careful track of these studies from planning to publication. The articles managed by Pfizer comprised between 18 and 40 percent of all articles published on the drug between 1998 and 2000.

These articles were universally positive about the drug and under-reported its side effects. They were also published in more prestigious journals and were cited nearly three times as frequently as more critical articles not managed by the company.

Ghost management has become such a huge industry that a professional association has even been established for it -- the International Publication Planning Association.

Sismondo notes that while Healy and Cattell looked at only one drug, the evidence suggests that ghost management is widespread. When it was revealed that a journal article on Merck's drug Vioxx had failed to mention the deaths of certain participants, for example, lead author Jeffrey Lisse pleaded innoncence: "Merck designed the trial, paid for the trial, ran the trial," Lisse said. "Merck came to me after the study was completed and said, 'We want your help to work on the paper.' The initial paper was written at Merck, and then it was sent to me for editing."

Why the FDA doesn't want to regulate tobacco

A proposed law that would give the FDA the authority to regulate tobacco products have garnered a wide degree of support -- including from Philip Morris, the world's largest tobacco company.

The Family Smoking Prevention and Tobacco Regulation Act would give the FDA the same authority to regulate tobacco products that it currently has to regulate foods, drugs and medical devices. This means that the FDA would be responsible for approving all new tobacco products (but not products already on the market) and for regulating the levels of harmful ingredients in tobacco products and smoke.

Cigarette smoke contains an estimated 4,000 chemicals, and more than 40 have been identified as carcinogens.

The act would also strengthen the health warnings on tobacco products and prohibit the use of false claims in marketing, including "light" and "low tar." It would place stricter restrictions on the advertising of tobacco products.

According to some critics, it is this last clause that has led Philip Morris to support the proposed law. "If you make it more difficult to communicate with smokers, and you have half the market, it results in the market share getting locked in," said John W. Singleton, director of communication for Reynolds American, Inc., the second largest tobacco company in the United States. "If you get locked in at 50 percent, that's pretty good. The bill gives Phillip Morris a competitive advantage."

Cigarette brands produced by Reynolds American subsidiaries include Camel, Kool, Pall Mall, Salem and Winston.

Philip Morris subsidiary Philip Morris USA is the largest tobacco producer in the United States, controlling 50 percent of the consumer market. Philip Morris brands include Marlboro, the most popular cigarette brand in the world.

According to Philip Morris USA President Howard Willard, the company supports the proposed law because FDA regulation of tobacco products has been called for by the U.S. Institute of Medicine.

Why would Big Tobacco support regulation of tobacco?
Rival tobacco companies are not the only ones skeptical of Philip Morris' motivations. According to Stanton A. Glantz, director of the Center for Tobacco Control Research and Education at the University of California-San Francisco, the company's support was one of the main factors that convinced him to oppose it.

"I remain skeptical of the bill, because it's basically going to benefit Philip Morris," Glantz said. "I think that the FDA should have control over tobacco, but not on terms that Philip Morris wrote. I think that the people who are supporting this bill will live to regret it."

The House version of the bill already has 200 sponsors, while the Senate version has 55. According to Mathew L. Myers, president of the nonprofit Campaign for Tobacco Free-Kids, more than 500 public advocacy groups are also supporting the proposed law.

Why the FDA doesn't want to regulate tobacco
But the call for FDA regulation is being vigorously opposed by the agency itself, which insists that it is ill-equipped to regulate tobacco products.

Because the FDA's role is to regulate products that are beneficial to public health, it cannot be asked to regulate products that are harmful, said FDA chief Dr. Andrew C. von Eschenbach. The act "would ask us to apply this [public health] framework to tobacco products that, when used as intended, produce disease rather than promote health. FDA cannot 'approve' a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks."

Giving tobacco products the seal of FDA approval might mislead consumers into thinking that those products are safe or even good for their health, von Eschenbach said. In addition, the agency does not have the financial or staff resources that would be required to regulate the giant tobacco industry.