Public Citizen issued the following press releases today:

1. Patients in the Dark About Cholesterol Drug Recall

2. USDA Tells Inspectors to Give Deference to Meat Companies, Stop Production Lines Only in Certain Circumstances

Oct. 31, 2002

Patients in the Dark About Cholesterol Drug Recall

FDA Needs Statutory Authority to Order and Enforce Recalls; Drug Industry Should Pay for Patient Notification, Consumer Advocate Says

WASHINGTON, D.C. - A study showing that only a fraction of patients at a Chicago hospital clinic who had been prescribed a cholesterol-lowering drug were aware of its subsequent recall underscores the need for more effective recall systems, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, wrote in an editorial accompanying the study. The study, available online Oct. 31, will be published in the December issue of Pharmacoepidemiology and Drug Safety.

Researchers at Cook County Hospital surveyed patients who were taking cerivastatin, popularly called Baycol, after the drug's maker voluntarily recalled the drug in the United States. The drug was recalled in August 2001 after 416 cases of severe muscle damage, including 31 deaths, were associated with it.

Patients taking cerivastatin along with gemfibrozil, prescribed to control triglyceride levels, were at an increased risk for muscle damage. Sixty-seven Cook County patients had been prescribed the drugs together. Of the patients taking the drugs together whom the researchers could reach, only a fifth had heard of the recall and more than half continued to take cerivastatin. Forty percent of the surveyed patients had physical symptoms of muscle damage, almost half of them severe.

Because virtually all recalls are voluntary, the U.S. Food and Drug Administration (FDA) has a limited ability to ensure that patients are aware of a drug's withdrawal. The responsibility then falls to pharmacists, who maintain computerized databases of prescriptions and can effectively notify patients but often don't. Wolfe's editorial suggests that the funding for such notification should come from the recalled drug's manufacturer.

"When they look at their bottom lines, pharmaceutical companies apparently conclude that they'll save more money by paying a few settlements to patients who have been injured or to families of those who have been killed by a dangerous drug than by funding a patient notification program," Wolfe said.

Not only should drug makers bear the cost of notifying patients, but the FDA should be given authority to impose mandatory drug recalls and regulate the level and speed of a recall and patient notification, Wolfe said. It is also essential that the FDA obtain the legal authority to impose civil monetary penalties if pharmaceutical companies were to violate FDA's new authority, Wolfe wrote.

The finding that so many patients were unaware of the early symptoms of rhabdomyolysis, the severe muscle damage, highlights the need for FDA oversight and approval of MedGuides - patient information leaflets handed out at the time a prescription is filled - to alert patients to such symptoms.

"Because cerivastatin was causing severe muscle damage to hundreds of patients and killed dozens of people, there should have been a major effort to ensure that all patients were aware of the dangers and stopped taking the drug," Wolfe said. "Drug makers are not doing enough to protect consumers, and the FDA needs the authority to hold them accountable."

Wolfe also noted that about 10 months before the August 2001 withdrawal of cerivastatin, Bayer underbid drug companies that had been previously supplying statins for the Cook County clinic. In November of 2000, cerivastatin, for which the clinical benefits are unproven, replaced three previous statins used by the clinic, all of which have been found in clinical trials to lower cholesterol and reduce the risks of major coronary events and mortality.

###

Oct. 31, 2002

USDA Tells Inspectors to Give Deference to Meat Companies, Stop Production Lines Only in Certain Circumstances

Leaked Memo Shows Constraints on Authority of Meat Inspectors,

Helps Explain Why USDA Pushes Irradiation

WASHINGTON, D.C. - Advocacy groups Government Accountability Project (GAP), the Community Nutrition Institute and Public Citizen sent a letter to Agriculture Secretary Ann Veneman today asking her to explain why her agency is tying the hands of government meat inspectors when it comes to preventing fecal contamination of meat, while at the same time promoting the controversial technology of food irradiation to deal with the E. coli that comes from such contamination. Field instructions to meat inspectors, obtained recently by GAP, outline the constraints on inspectors' authority in the plants.

The USDA has evidently backed away from its "zero tolerance" stance on fecal contamination, as can be seen in the written instructions for USDA meat inspectors working in Kansas, where 20 percent of red meat in the U.S. is produced. The field instructions set a high hurdle before inspectors can require a plant to take specific corrective action.

The instructions repeatedly state that stopping the production line is to be avoided at all costs and that the inspectors themselves will be held responsible for lost production if the company challenges their action.

"These directions shed some light on the thinking at USDA headquarters: Officials would rather promote irradiation and have consumers eating sterilized filth than stand up to meat companies and stop the line when there is a problem," said Wenonah Hauter, director of Public Citizen's Critical Mass Energy and Environment Program.

The memo warns that:

"stopping production for 'possible' cross contamination*is unjustifiable unless you can verify that there is direct product contamination. Verification is OBSERVATION of gross contaminate not SUSPECTED contaminate. This is the only criteria for justifying halting production."

This low standard extends even to fecal matter, which is the source of deadly pathogens such as E. coli 0157:h7. While the memo mentions the official "zero tolerance" policy on fecal contamination, the document narrowly defines such contamination, constraining when inspectors can act.

"We will allow the company a chance to trim [feces, stomach contents, or milk] off on the moving lines unless it is so excessive, that it must be corrected with the line stopped. You are responsible for the time the line is off," the memo dictates. "Remember, YOU are accountable for this very serious responsibility of stopping the company's production for the benefit of food safety* verifiable ingesta or feces is as follows: a material of yellow, green, brown or dark color that has a fibrous nature," the memo states.

But this directive can lead to dangerous consequences if followed. According to Paul Johnson, acting chairman of the National Joint Council of Food Inspection Locals, "By not taking immediate action when you suspect there is a problem, you increase the odds that one contaminated piece of meat can contaminate machinery, employees and other products. Further, inspectors know that a small smear of feces can have deadly consequences just as easily as an amount large enough to have 'a fibrous nature' - yet the USDA prohibits us from taking action that could protect consumers."

Added Felicia Nestor, food safety project director of GAP, "The USDA is abandoning the zero tolerance standard for any fecal contamination on beef and replacing it with a new standard - wholesome unless there is 'gross' contamination. It's impossible for this standard to coexist with the agency's claim that it makes decisions based on science. 'Gross' is an inherently subjective standard."

Earlier this week, a controversy erupted over the USDA's possible plans to include irradiated meat in the food it purchases for the National School Lunch Program. According to Hauter, "No long-term studies of the effect of eating irradiated food have been done. The USDA would rather feed irradiated food to schoolchildren than let their inspectors have the authority to make sure the meat is wholesome."

Irradiation uses gamma rays, X-rays or accelerated electrons that alter the molecular structure of food in an attempt to kill pathogens and insects. The process destroys nutrients, may change the taste, smell and appearance of food, and produces new chemical compounds, some of which have been found to promote cancer and cause genetic and cellular damage in rats and human cells. Irradiation is a distinctly different process from pasteurization, which uses rapid heating and cooling to partially sterilize liquid products, namely milk.

The groups called on Veneman to:

· Withdraw any directive to inspectors and other inspection personnel to allow fecal contamination; · Issue instructions to all field staff directing that the zero tolerance rule for fecal contamination must be applied under any and all circumstances; and

· Maintain the current prohibition on irradiation for commodities purchased for all of the nutrition programs which USDA administers because, with a proper regulatory scheme, there will be minimal need for interventions.

"We believe these are the minimum management actions the secretary must take to the halt the erosion of public confidence in the safety of the nation's food supply," said Rod Leonard, executive director of the Community Nutrition Institute and former administrator for USDA's Consumer and Marketing Service that included meat and poultry inspection.

###

If you would like to be removed from this list, please reply to this e-mail and type "unsubscribe" in the subject line.