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Tag: health risks
Drug Makers Battle Health Warning Rule For Generics

Drug Makers Battle Health Warning Rule For Generics

WASHINGTON _ Companies that make generic drugs, the medications most Americans buy, are fighting to kill a proposed federal regulation that would require them for the first time to warn patients of all the known health risks of each drug they sell.

The proposed rule change by the Food and Drug Administration “would be nothing short of catastrophic,” said Ralph G. Neas, president of the Generic Pharmaceutical Association, an industry trade group. It could raise health care costs and “create dangerous confusion” for doctors and patients, he said.

At issue is a legal loophole created by Supreme Court rulings that drew a sharp distinction between brand-name drugs and lower-cost generics, which are the same products but usually are marketed under their chemical names.

In 2009, the high court confirmed drug makers could be sued if they failed to warn patients that a brand-name drug carried a serious potential health risk.

The decision upheld a $7 million jury verdict for Diana Levine, a Vermont violinist whose lower arm was amputated after she was injected with an anti-nausea drug made by Wyeth. The drug sometimes caused gangrene if injected into an artery.

But the Supreme Court majority flipped when confronted with a generic drug that also caused a horrible side effect.

Last year, a 5-4 ruling tossed out a $21 million verdict awarded by a lower court to Karen Bartlett, a New Hampshire woman who was disfigured, badly burned and nearly blinded after she had a rare, but previously reported, reaction to a prescription painkiller.

Had Bartlett taken the brand-name drug Clinoril for her shoulder pain, she would have won her claim. But her pharmacist gave her the generic drug sulindac. And at the time, the product label did not warn patients or their doctors of the rare reaction, known as Stevens-Johnson syndrome.

Nonetheless, the court ruled generic makers were shielded from lawsuits such as Bartlett’s.

Justice Clarence Thomas, who cast a key vote, reasoned that because federal regulations say generics must be exact copies of the approved brand-name drugs, their makers cannot revise or update warning labels when new risks come to light. And so, he said, they cannot be sued for failing to warn consumers.

The dissenters said this made little sense. “Nothing in the court’s opinion convinces me that … Congress intended these absurd results,” said Justice Sonia Sotomayor.

In November, the FDA proposed to fix the problem by allowing generic makers to change their warning labels when reports of new problems arise.

“In the current marketplace, approximately 80 percent of drugs dispensed are generic drugs,” the agency said. “Accordingly, there is a need for [generic drug producers] to [be] able to independently update product labeling to reflect certain newly acquired safety information.”

The proposed rule change would extend legal liability as well. Any company that makes generic drugs would have an “independent responsibility to ensure its product labeling is accurate and up-to-date,” the FDA said.

The proposal met fierce opposition from the generic drug industry. Its members said they “cannot support a proposed rule that undermines public health merely to facilitate litigation against generic drug companies by the plaintiff’s bar.”

Neas, who heads the industry group, noted that generics had lowered many Americans’ health care costs. A study by the independent IMS Institute for Healthcare Informatics said generics had lowered health care costs by $1.2 trillion over the last decade.

Neas formerly led the Leadership Conference on Civil Rights and the liberal advocacy group People for the American Way, and he was credited with helping organize a national campaign that helped derail the Supreme Court nomination of Judge Robert Bork in 1987.

Neas described his group’s fight against the proposed rule change as a national public education campaign.

“Our aim is to get the facts out there,” he said. “This will go for some time. I don’t believe this (proposed) rule benefits anyone in the health care system.”

The FDA had planned to complete work on the proposal after hearing comments through January. It agreed to postpone the deadline until March in response to complaints from the generic drug makers.

But the rule change has the backing of congressional leaders who follow health policy. They include Rep. Henry A. Waxman, D-Calif., co-sponsor of the 1984 Hatch-Waxman Act, which is credited with spurring the widespread adoption of generic drugs.

“Patients should have the same rights to seek compensation if they are injured by a drug, regardless of whether it is a brand-name or a generic,” Waxman said in an interview. “It doesn’t make sense,” he said, to have patients’ rights depend on which version of a drug they took.

A growing number of drugs are sold only as generics. That shift argues for changing the federal warning rules, said Dr. Michael Carome, director of Public Citizen’s Health Research Group, a nonprofit organization.

“Many potential hazards are not discovered until years after drugs have been on the market,” he said. “The proposed rule would remedy this public health problem” by requiring generic makers to disclose new safety risks as they are known, he added.

Photo: epsos.de via Flickr

U.S. Study Finds Pesticide May Raise Risk Of Alzheimer’s

U.S. Study Finds Pesticide May Raise Risk Of Alzheimer’s

Washington (AFP) – People with Alzheimer’s disease may have higher levels of a chemical left behind by the pesticide DDT than healthy elderly people, suggested a U.S. study out Monday.

The pesticide, DDT, was phased out in the United States in 1972, but is still used elsewhere in the world and global health authorities consider it an important tool against malaria.

Researchers found DDE, the long-lasting metabolite of DDT, was nearly four times higher in Alzheimer’s patients than in peers without the disease.

Having high DDE levels was also found to increase someone’s risk of Alzheimer’s fourfold, according to the study which compared 86 Alzheimer’s patients to 79 people of advanced age.

The patients in the study came from the US states of Texas and Georgia, and their average age was 74, according to the study published in the Journal of the American Medical Association (JAMA) Neurology.

Outside experts cautioned that its sample size was small and should be followed with more research.

“The findings should be a stimulus to further research using more rigorous epidemiological methods, but of themselves, they do not provide strong evidence of a hazard,” said David Coggon, professor of occupational and environmental medicine at the University of Southampton in Britain.

The differences in DDE levels were seen in the Texas sample, but not in Georgia, noted an accompanying editorial in JAMA Neurology by doctors at the University of Pennsylvania and the University of Virginia.

The editorial writers, Steven DeKosky and Sam Gandy, noted that the research should be considered “preliminary until there is independent confirmation in other populations.”

Little is known about what causes Alzheimer’s disease, which afflicts five million people in the United States.

The World Health Organization says some 35 million people around the world are living with dementia.

“This is one of the first studies identifying a strong environmental risk factor for Alzheimer’s disease,” said a statement by study co-author Allan Levey, chair of neurology at Emory University School of Medicine. “The potentially huge public health impact of identifying an avoidable cause of Alzheimer’s disease warrants more study — urgently.”

AFP Photo/Will Oliver

Recent Accidents Increase Pressure For New, Safer Energy Sources

In recent years, the main debate surrounding energy sources has focused on economic and, to some extent, environmental factors. But the existing methods of energy production and transportation also pose grave health risks to humans — a fact shown by recent disasters that could add more urgency to the development of safer energy sources.

Nuclear energy has long been criticized for its deadly potential, a concern that is intensified in the wake of perennial disasters. On Monday, an explosion at the Centraco site that treats nuclear waste in southern France killed one person and hurt four. France, which is more dependent on nuclear energy than any other country worldwide, was relatively lucky in that the accident did not result in radioactive leaks that might affect more people. Japan was not as fortunate in their own nuclear accident earlier this year: the leaks from a tsunami-hit nuclear plant contained the same amount of radioactive cesium as 168 of the atomic bombs dropped on Hiroshima. The risks at nuclear plants have made many people question the benefits of the energy source: a Pew poll from March found increasing opposition to nuclear power. Even though accidents are rare, they have disastrous potential.

France was not the only country that experienced a fatal accident involving energy on Monday: a leaking gasoline pipeline in Kenya created an explosion that killed at least 75 people and injured more than 100. The explosion set shacks ablaze in the slum near the pipeline, as people tried in futility to escape the fire. The situation in Kenya is even more tragic when considering that many of the victims would not have been the beneficiaries of the fuel supply; they bear the risks while the wealthy elite and international community reap the benefits. Such disasters are far too common, and they would presumably not be as tolerated and ignored if those affected had a different skin color and social status.

These recent tragedies emphasize the need to consider the human as well as economic and environmental impact of energy sources. As scientists and politicians discuss the fuels of our future, the recent loss of lives should make it even more apparent that more resources should be dedicated to enforcing regulations and developing safer energy sources.

Obama has already faced several key energy-related crises during his presidency, and his failure to take clear steps toward new energy sources — as he had pledged in his campaign — might haunt him as he seeks reelection. The frequency of accidents related to old energy sources have made people more frustrated with the government’s ineffectiveness in supporting new energy. Some of the administration’s greatest blows resulted from such incidents: The president did not take quick, decisive action after the 2010 BP oil spill that killed 11 workers and had a critical impact on everything from birds to fishermen. Instead, many dangerous drilling practices have been able to continue. The episode disappointed already-disenchanted environmentalists who had helped secure the presidency for Obama in 2008.

The administration continues to grapple with energy debates, and Obama has new opportunities to take a stand for safer energy sources. Environmentalists protested last month against the construction of a new pipeline that would carry oil from the Canadian tar sands to the Gulf of Mexico, voicing concerns that the existing pipeline has already leaked several times. The State Department issued a report favoring the controversial project, but Obama still has the opportunity to halt the construction. Otherwise, he risks losing the last shreds of support from environmentalists outraged at his recent cancellation of potential new Environmental Protection Agency rules on ozone emissions.

The environmental necessity of developing new energy strategies is well-known to most rational people, but the human toll should also be considered as part of the energy debate. As the risks of existing energy sources become even more apparent in light of recent fatal accidents, the incentive to invest more money in alternative energy has never been greater.