Bloomberg recently ran an article about pharmaceutical companies enjoying their “get out of jail free cards” — revisions to regulations that favor the rights of pharmaceutical companies over consumers who use their drugs. The revised regulations, written just after George W. Bush’s second inauguration in 2005, allow federal law to trump state law, thereby clearing the path for drug manufacturers to develop, test, market, and essentially do business with impunity from the law.

Think corporate Utopia. Think David vs. Goliath where Goliath enjoys a major handicap.

According to the U.S. Constitution, any decision to pre-empt state law must be authorized by Congress. However, several federal agencies have navigated around that obstacle (probably whining that it takes an act of Congress to trump state law) by inconspicuously writing language into the preamble of federal regulations and then using those preambles to change the law.

The issue, however, is not as clear cut as it would seem. Some trial courts have ruled the regulatory preambles to be permissible. The American Association for Justice on the other hand belies them to be unconstitutional. In any case, pre-emption effectively strips state government and courts – and the U.S. Congress – of its authority.

Not exactly the antithesis of “big government,” yet some politicians would whisk away any concerns as tort reform. To get a clearer picture of the dangers posed by corporate immunity, look at the individual cases – the examples of real people who are grappling with greatly diminished protection.

Look at Joe Randone and his family, who are suing Bayer. Randone was a 52-year-old heart patient when he was given Trasylol in an IV drip. Immediately after the surgery, Randone suffered from two heart attacks and kidney failure. His gall bladder had to be removed and he was so swollen he couldn’t close his eyes, which were eventually sewn shut to protect his corneas. Gangrene set in to his lower extremities and both of his legs had to be amputated. Randone held on like this for 8 months but ultimately passed away in his hospital bed. All of this happened while Bayer, the manufacturer of Trasylol, was aware of the drug’s dangers and took no measures to prove its safety one way or another, even after smaller tests indicated the drug was highly toxic.

Bayer is claiming immunity in the Randone  case because Trasylol was approved by the FDA. Also, language in the preamble to the FDA’s prescription drug labeling rule also may turn out to be an easy escape route for Bayer.

Who are the government and the FDA really protecting? Pharmaceutical companies and medical device manufacturers are businesses; they need to make profits and their pipeline must look promising to investors. Loosening regulations and excusing corporations from accountability, however, seems to be as shortsighted as it is callous.

As scores of people become injured or die from taking newer, barely tested medications, doesn’t it stand to reason that doctors and patients would want to stick with the tried and trusted generics? How long will it be before the regulations intended to help corporations cause them to implode?

SOURCE: Trasylol Recall › Pre-emption could give Bayer an escape from Trasylol case

Think corporate Utopia. Think David vs. Goliath where Goliath enjoys a major handicap.

According to the U.S. Constitution, any decision to pre-empt state law must be authorized by Congress. However, several federal agencies have navigated around that obstacle (probably whining that it takes an act of Congress to trump state law) by inconspicuously writing language into the preamble of federal regulations and then using those preambles to change the law.

The issue, however, is not as clear cut as it would seem. Some trial courts have ruled the regulatory preambles to be permissible. The American Association for Justice on the other hand belies them to be unconstitutional. In any case, pre-emption effectively strips state government and courts – and the U.S. Congress – of its authority.

Not exactly the antithesis of “big government,” yet some politicians would whisk away any concerns as tort reform. To get a clearer picture of the dangers posed by corporate immunity, look at the individual cases – the examples of real people who are grappling with greatly diminished protection.

Look at Joe Randone and his family, who are suing Bayer. Randone was a 52-year-old heart patient when he was given Trasylol in an IV drip. Immediately after the surgery, Randone suffered from two heart attacks and kidney failure. His gall bladder had to be removed and he was so swollen he couldn’t close his eyes, which were eventually sewn shut to protect his corneas. Gangrene set in to his lower extremities and both of his legs had to be amputated. Randone held on like this for 8 months but ultimately passed away in his hospital bed. All of this happened while Bayer, the manufacturer of Trasylol, was aware of the drug’s dangers and took no measures to prove its safety one way or another, even after smaller tests indicated the drug was extremely dangerous.

Bayer is claiming immunity in this case because Trasylol was approved by the Food and Drug Administration. However, language in the preamble to the FDA’s prescription drug labeling rule may provide the easiest escape route for Bayer.

Who are the government and the FDA protecting? If pharmaceutical companies and medical device manufacturers receive complete immunity from the law, then they can knowingly market and sell dangerous drugs that leave scores of people injured or dead.

It is through the courts, and litigation, that the voice of the consumer is heard, and his rights protected. A recent editorial by the editors of the New England Journal of Medicine supports this idea.

SOURCE: Trasylol Recall › Zero accountability for drug companies?

The two aspirin products, Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, are misbranded, mislabelled, and confusing to consumers, according to the FDA.

According to Bayer, its Women’s Low Dose Aspirin fights heart disease and osteoporosis with a combination of 81 mg of aspirin and the equivalent of an 8-oz glass of milk in calcium for possible “lifesaving benefits.”

Bayer Heart Advantage combines the same low dose of aspirin with plant phytosterols, molecular entities found in fruits and vegetables that are valuable for their cholesterol lowering properties.

While Bayer’s web site instructs users to talk to their doctors before beginning any aspirin regimen, the message isn’t so clear on the medicine’s packaging. Both Bayer medicines are packaged to appeal directly to consumers, who might be lead to think that they can treat their heart conditions, cholesterol, and osteoporosis with these OTC medicines.

The FDA requires that medicines designed to treat heart disease and osteoporosis be reviewed by its researchers. Federal law also forbids such medications to be sold OTC.

Labeling on Bayer’s Heart Advantage claims that the drug lowers cholesterol. Labeling for Bayer Women’s says that it fights osteoporosis. Improper use of medicines containing aspirin often causes serious side effects such as gastrointestinal bleeding. Aspirin resistance can also have devastating effects on the heart.

Bayer believes that neither products violate FDA regulations, but promises to review the case and report back to the FDA within 15 business days. The FDA indicated in its letter to Bayer that the company would face legal action.

Bayer is already under fire by the FDA and general public for its marketing of Trasylol when ample studies found the drug to be highly toxic to many people.

SOURCE: Trasylol Recall › FDA warns Bayer about two OTC aspirin products

Both complaints were filed in the St. Clair County Circuit Court.

Gary Harms received a Trasylol injection in 2005 while he was undergoing heart surgery at Des Peres Hospital in St. Louis, Missouri. He has since suffered from acute renal failure and requires regular dialysis to perform the functions of his failed kidneys.

Researchers first discovered a link between Trasylol and kidney failure in the early 1980s when lab animals that received the drug developed severe kidney failure. Subsequent tests confirmed Trasylol’s danger to humans, yet Bayer consistently denied the existence of a link between their drug and acute renal failure and death. The company also failed to fund and perform adequate clinical tests that would have conclusively demonstrated the drug’s risks.

Harms’ suit claims that he has suffered from emotional distress and anxiety, physical personal injury, medical expense, loss of consortium, services, love and affection, permanent loss of an important bodily function, permanent impairment of the ability to enjoy life and financial expenses. He seeks $550,000 in addition to attorney’s fees and other costs.

Richard Kopsie also received Trasylol during his coronary artery bypass graft surgery at Christian Hospital in St. Louis, Missouri in 1996. He experienced kidney failure shortly after surgery and required dialysis for years. Kopsie passed away in March 2003 at the age of 53, but his final years were marked by pain and suffering from Trasylol-induced injuries, medical costs, disability, and a diminished ability to enjoy life, according to the complaint filed by his wife Linda.

Linda Kopsie seeks a $1.1 million on 22 counts plus attorney’s feels and other costs against Bayer.

Both suits claim that Bayer acted negligently for continuing to market Trasylol when the drug’s dangers were known, for failing to alert the FDA to dangers of the drug, and failing to attach appropriate warnings and safety information to the drug. For years, Bayer also avoided performing large scale tests that would have effectively underscored the drug’s dangers.

SOURCE: Trasylol Recall › Two suits filed against Bayer in Illinois

Known as BART, the study randomly administered one of three drugs to the patients: Trasylol, Cyklokapron (tranexamic acid) and Amicar (aminocaproic acid).

BART sought to answer questions about Trasylol’s safety and efficacy, despite the fact that the drug has been in use for over twenty years. Was Trasylol more effective than alternative drugs in controlling bleeding during cardiac surgery? And, how did rates of death, organ failure, and other serious complications measure in Trasylol compared to the alternative drugs?

Experts conducting the study found that Trasylol’s safety risks were so high, they ended the trial before its scheduled completion. Death rates among Trasylol patients were alarmingly higher than in patients who were given the alternative therapies. Dr. Paul C. Herbert, a critical care physician at Ottawa Hospital and one of the lead investigators, told BusinessWeek magazine that Trasylol represented a 53% increase in risk in dying compared to the other drugs. That “translates into for every 50 patients treated with aprotinin, one patient would die,” he explained.

Strangely, earlier Trasylol tests were small and not designed to study death. Information about the drug’s toxicity in some patients, therefore, remained hidden.

Dr. Eric J. Topol, director of the Scripps Translational Science Institute and dean of the Scripps School of Medicine, reacted to the results of BART with the same frustration as many North American consumers. In remarks made to BusinessWeek magazine, he wondered “why it takes so long for the truth to come out.”

“How many patients were lost because of this misadventure in therapeutics?” he asked.

SOURCE: Trasylol Recall › One in fifty Trasylol patients dies

Beginning immediately, Trasylol will belong to a class of drugs that require a special protocol for use. Patients who are at a high risk for blood loss during coronary artery bypass graft surgery may receive Trasylol if no alternative therapies are appropriate. In such cases, physicians must follow a special treatment protocol and submit it to the FDA for approval. The physician must show that the benefits of administering Trasylol outweigh the risks.

Trasylol is an antifibrinolytic drug that reduces excessive bleeding by slowing the breakdown of blood clots during heart surgery. In October 2007, the Data Safety Monitoring Board (DSMB) recommended the discontinuation of patient enrollment in a randomized Canadian study of aprotinin. The study was stopped once data suggested an increased risk of death in patients who had received Trasylol.

The FDA will reassess its special treatment protocol for Trasylol once it receives and has reviewed data from the study’s researchers. According to the FDA’s statement, “the FDA oversight requires comprehensive and thorough studies of a drug not only during the pre-market review phase but throughout the drug’s life cycle.” Many critics of the FDA object to the administration’s method of drug approval, which, they argue tests effectiveness of new medicines but not safety.

SOURCE: Trasylol Recall › FDA announces withdrawal of remaining Trasylol

Trasylol, Bayer’s injectable aprotinin for heart patients, is largely responsible for the gloom that many analysts forecast for Bayer. Approved by the FDA in 1993 for use in controlling blood loss during heart bypass surgery, Trasylol was administered to nearly 5 million patients around the world. However, two extensive studies published last week in the New England Journal of Medicine revealed the risk of death to be dangerously high in patients who had received Trasylol injections. The drug was found to double the risk of liver damage, kidney failure, cardiac arrest, and heart failure. Moreover, it quadrupled the risk of stroke.

Bayer agreed to suspend marketing of Trasylol in November of last year following preliminary results of a Canadian test that indicated the drug’s link to increased risk of death. The FDA is reviewing the test results, but it’s likely that Trasylol is soon to be a thing of the past.

Trasylol controversies are just one of Bayer’s problems right now. Its performance in other markets evokes the image of an Olympic athlete jumping hurdles with a broken leg. A trial for one of Bayer’s next-best things, a drug called Nexavar, revealed that it was ineffective in the treatment of lung cancer. Also pharmaceutical companies Novartis and Novo Nordisk took Bayer to court over the hemophilia drug Kogenate, claiming that the drug infringes on their patents. Kogenate represents well over $1 billion in annual sales for Bayer.

All of these setbacks, it should be noted, are contained within the drug arm of Bayer – a large and diversified company on the brink of celebrating its 150th birthday. In addition to prescription pharmaceuticals, Bayer’s conglomerate includes over-the-counter health care, chemical research and development, and crop protection. The old giant may seem a little too unfocused and clunky to truly compete in the pharmaceutical arena, but its diverse ventures help to safeguard it from the risky and unsteady world of big pharma.

SOURCE: Trasylol Recall › Trasylol: just one of Bayer’s woes

Months later, Randone was still in the hospital fighting a losing battle for his life. The problem began during surgery, when Randone was hooked to an IV drip containing Trasylol for four hours.

Trasylol is administered to control blood loss during heart surgery. It is one of the most widely used drugs worldwide for that purpose.

After the surgery, the doctor told Randone’s wife Josephine and daughter Marissa that something was wrong, that Joe was experiencing complications.

“They didn’t go into specifics,” Marissa told the television program 60 Minutes. “Just that there were a lot of complications, and that making it through the night was basically our first concern.”

Just after surgery, Joe Randone experienced two heart attacks. Then his kidneys failed. Randone’s surgeon rightfully suspected that Trasylol was at fault. He recorded Randone’s complications as “aprotinin-induced graft thrombosis.” In other words, blood clotting caused by Trasylol.

Randone battled for his life in the months following his Trasylol IV. He was placed on dialysis so that machines could perform the work of his kidneys.

“It was a domino effect. Once the kidneys stopped working, then it affected other organs. He was so swollen that he couldn’t even close his eyes,” Josephine told CBS.

Circulation was so poor in Randone’s lower body that gangrene settled into both of his legs. Both legs were subsequently amputated.

Josephine described the experience as “a living hell” for both Joe and his family.

Randone died eight months after his heart surgery. His family filed a suit against Bayer in Suffolk County for $80 million.

Randone’s surgeon, Dr. Todd Rosengart, has filed a report with the FDA and has stopped using Trasylol.

SOURCE: Trasylol Recall › Death by Trasylol: one man’s story