Drug giant, Pfizer, has reached an agreement that will ultimately settle most of the lawsuits filed against the company over the side effects of two of it’s drugs, Celebrex and Bextra. It expects that the $894 million dollar agreement will settle more than 90 percent of the claims filed because the drugs are alleged to have caused major side effects to the plaintiffs - heart attacks and strokes.

Pfizer hopes that this will be accomplished by year’s end and also hopes that remaining claimants will be included in the settlement.

General Counsel Amy Schulman told The Associated Press that Pfizer will fight any remaining personal injury suits with court motions or at trial. “I don’t think either side has an interest in protracting this,” Schulman said in an interview.

Out of the total settlement, $745 million will go to settle personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs. Two additional states, Louisiana and Mississippi, still have pending cases regarding Pfizer’s promotion of the drugs.

Schulman has indicated that Pfizer had been negotiating with opposing lawyers for some time. “Litigation can be distracting, and putting these matters behind us helps our shareholders and, most importantly, patients and doctors,” Schulman said.

Pfizer had removed Bextra from the market in 2005 after Merck & Company had removed it’s painkiller, Vioxx, from the market. Merck has begun paying a 4.8 billion dollar settlement that ends about 50,000 lawsuits that claimed Vioxx caused heart attacks, strokes and death.

Celebrex is currently the only Cox-2 inhibitor that the Food and Drug Administration has allowed to stay on the market. These drugs - Bextra, Celebrex and Vioxx - were superior to the usual nonsteroidal anti-inflammatory drugs(NSAIDs) like aspirin, ibuprofen and naproxen because they inhibited only the body enzymes that produced the inflamation(Cox-2). The NSAID drugs also inhibited the Cox-2 enzyme but, in addition, inhibited the Cox-1 enzyme which is important in keeping the mucous lining of the stomach intact. Without the mucous lining, stomach ulcers and bleeding could occur.

The National Highway Traffic Safety Administration (NHTSA) once again has launched a “pre-emptive” strike against state personal injury suits by inserting a pre-emption provision in a new rule governing seat belt safety, according to consumer and trial lawyer groups.

The rule, known as the “designated seating position” rule, not only revises how it is determined how many seat belts are required in a vehicle, it has language that very specifically would pre-empt  state suits related to seat belt injuries.

Joan Claybrook, president of Public Citizen and a former administrator of NHTSA, said the agency has issued safety standards with such pre-emption language 20 times in the past three years.

“The fear of lawsuits is one of the greatest incentives automakers have to build stronger and safer vehicles,” she said. “For NHTSA to suggest that automakers should have blanket immunity from consumer liability lawsuits means that more defective vehicles will be manufactured, fewer will be recalled, the public will have less information about injury causation and more families will needlessly lose loved ones on our roads each day.”

The business community sees pre-emption differently saying that pre-emption gives them one set of rules to play by instead of having to deal with the federal regulatory system as well as the tort and jury systems.

Came across an interesting article about pre-emption written in January of 2008 - The Emerging Threat of Regulatory Preemption - written by David C. Vladeck.  In his article he writes about how pre-emption has been used in four  federal agencies:  Food & Drug Administration(FDA), Consumer Product safety Commission(CPSC), Federal Railroad Administration(FRA) and National Highway Traffic Safety Administration.   His conclusion:

While the public watches the Supreme Court wrestle with the preemption questions presented in Reigel v. Medtronic, and perhaps in Wyeth v. Levine, the more troubling action is taking place out of public view. The quiet but insidious erosion of state tort law remedies — and the health and safety benefits that are associated with them — continues unabated. Our health and safety agencies have been subject to a hostile-takeover by an Administration that cares more about constituent-serving outcomes than their statutory mission to protect the public. The winners will be the Administration’s corporate patrons who will be given the immunity from tort liability they never could have gotten from Congress. The loser will be the tens of thousands of Americans injured through no fault of their own but who will no longer have any means of redress.

The current salmonella outbreak which has been linked to certain types of raw tomatoes - red round, plum and Roma - has now affected over 1000 people. This makes it the worst food-borne outbreak in over ten years and now the Centers for Disease control and Prevention are urging people at high risk not to eat raw jalapeno or serrano peppers. Those at highest risk for severe salmonella illness are the elderly, infants and people with weak immune systems.

Now the Food and Drug Administration is looking for farms that may have grown tomatoes and then switched to peppers.

CDC food safety chief, Dr. Robert Tauxe, says he understands the frustration that people have over this outbreak but that they were working as hard as possible to sort out the situation.

At least 300 people became ill in June, with the latest falling sick on June 26. Two deaths are associated with the outbreak - a Texas man in his 80s, and another Texas man who died of cancer but for whom salmonella may have played a role - and 203 people have been hospitalized.

The toll far surpasses what had been considered the largest foodborne outbreak of the past decade, the 715 salmonella cases linked to peanut butter in 2006, Tauxe said. In the mid-1990s, there were well over 1,000 cases of cyclospora linked to raspberries, and previous large outbreaks of salmonella from ice cream and milk.

The possibility that there may be many other salmonella cases that have not been diagnosed and/or reported - possibly thirty or forty for every one reported - is of some concern to the CDC.

“The outbreak could actually be tens of thousands of people rather than 1,000 people,” agreed Caroline Smith DeWaal of the consumer advocacy Center for Science in the Public Interest. “It’s certainly a disturbing event to have this many illnesses spanning this many months.”

Wake Forest University Baptist Medical Center scientists will be conducting a trial to test a new cancer treatment which has promise of eradicating cancer in humans. The treatment involves getting specific white cells from select donors and infusing the white cells into patients who have advanced forms of cancer.

This new trial, approved by the Food and Drug Administration, is based on the discovery, about five years ago, of a cancer-resistant mouse. Later findings showed that white blood cells from that mouse and its offspring cured advanced cancers in ordinary lab mice. Since then, they have discovered that the white blood cells of some humans carry the same cancer-killing capability.

Zheng Cui, Ph.D., lead researcher and associate professor of pathology, announced the study June 28th at the Understanding Aging conference in Los Angeles.

“In mice, we’ve been able to eradicate even highly aggressive forms of malignancy with extremely large tumors,” Cui said. “Hopefully, we will see the same results in humans. Our laboratory studies indicate that this cancer-fighting ability is even stronger in healthy humans.”

The team has tested, in the laboratory, cancer-fighting cells against cervical, prostrate and breast cancer cells with good results. The anti-tumor response involves granulocytes, the most abundant type of white blood cell in humans. They can be donated without the donor losing other components of the blood. The team has indicated that up to three donors may be needed to collect enough blood product for one study recipient.

“The difference between our study and the traditional white cell therapy is that we’re selecting the healthy donors based on the cancer-killing ability of their white blood cells,” said Cui. The scientists are calling the therapy Leukocyte InFusion Therapy (LIFT).

The goal of the phase II study is to determine whether patients can tolerate a sufficient amount of transfused granulocytes for the treatment. Participants will be monitored on a regular basis, and after three months scientists will evaluate whether the treatment results in clear clinical benefits for the patients. If this phase of the study is successful, scientists will expand the study to determine if the treatment is best suited to certain types of cancer.