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?

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

The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA’s Office of New Drugs, said at an early morning news conference Monday.

However, he added, “The suspension will include a slow phase-out of Trasylol from the marketplace, to decrease the possibility of shortages of the alternative drugs.” And he added that Bayer could continue to supply the drug if physicians can identify specific patients who would benefit from it.

“Studies have found that Trasylol can increase the risk of kidney damage compared with other drugs,” Dr. Gerald Dal Pan, the FDA’s director of the Office of Surveillance and Epidemiology, said during the news conference.

In 2006, he added, the FDA limited the use of Trasylol and strengthened its warnings. Subsequently, he said, studies found that Trasylol increased the risk of in-hospital death among patients undergoing cardiac bypass surgery. In addition, Dal Pan said, two studies this year found that the drug increased the long-term mortality of patients who had undergone bypass surgery.

The suspension follows news last month that a major Canadian trial of the drug was terminated because of an increase in deaths for cardiac surgery patients using it.

The trial was designed to show that Trasylol was better than other drugs in controlling bleeding, Dal Pan said. “That study was halted because Trasylol appeared to increase the risk for death compared with two other drugs,” he said.

Based on these findings, the FDA requested last week that Bayer suspend Trasylol pending further review, Dal Pan added.

In a company statement on its Web site Monday, Bayer stressed that the suspension was temporary. “Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling,” the statement said.

The FDA also said Monday that it plans to do a detailed review of the preliminary results from the Canadian trial before deciding whether to allow Trasylol back on the U.S. market.

Trasylol was first approved by the FDA in 1993, and has had a checkered history since then.

In the Canadian trial, called BART, an elevated 30-day and overall death risk caused the study’s Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment. The trial had been set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.

On Sept. 12, a U.S. Food and Drug Administration advisory panel recommended that Trasylol remain on the market, despite mounting evidence that it might have serious side effects.

In February, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers had linked the drug to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.

“Our present findings deal with death,” one of the JAMA study’s authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that “the death rate for aprotinin patients far outstrips that for the other two drugs.”

His team’s study tracked the long-term survival of nearly 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide. The researchers tabulated survival at six weeks, six months, and then annually for five years.

The five-year death rate for patients given Trasylol was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid. Both alternative drugs are available in generic versions.

After the 2006 report from Mangano’s group, the FDA advised doctors to carefully monitor Trasylol patients for kidney, heart and brain damage — an action taken after Bayer disclosed study data showing that it increased the risk of death, kidney damage, congestive heart failure and stroke.

The drug does have its defenders.

Dr. T. Bruce Ferguson Jr., associate director of cardiothoracic and vascular surgery at East Carolina University, wrote an accompanying editorial to the JAMA study. He said he believed the study “was inadequate to address the question they were asking because of the way the database was designed.”

“The most important factor they were unable to control was why patients got aprotinin,” Ferguson said. “There were no data to address that issue, and therefore it cannot account for physician-related bias.”

For example, the higher rate of death and other complications linked to the drug might be due to aprotinin being prescribed for “higher-risk patients who could be expected to have a worse outcome and higher mortality,” Ferguson said. Other studies have shown that “in carefully selected patients, aprotinin is a good drug,” he said.

The information used in the study was thorough and complete, Mangano countered. “In terms of the database, we had between 7,000 and 10,000 pieces of data per patient from 59 centers in 16 countries, including 23 of the 25 top cardiac centers in the United States,” he said.

“The findings speak for themselves,” Mangano added. “I think they are as accurate as you can get.”

He believes that the drug’s use should be restricted to about 5 percent of patients in whom other drugs could not be used.

SOURCE: Trasylol Recall › Trasylol Pulled From Worldwide Market

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