Dangerous Imports and Drugs » heart disease

Medtronic raises death estimate tied to heart device wires

Gordon Johnson — Fri, 13 Mar 2009 16:36:00 +0000

Date: 3/13/2009

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — Medtronic, the world’s largest medical device maker, said Friday that 13 patients may have died as a result of problems with its heart device wires that were first disclosed in 2007.

The Minneapolis-based company pulled its Sprint Fidelis defibrillator leads off the market in October 2007 after identifying five patient deaths that may have been caused by the cracked wires.

In a letter sent to physicians Friday, Medtronic raised the number of estimated deaths to 13. The company notes that four of those deaths occurred when physicians tried to extract the wires. Medtronic has recommended patients leave the devices in because the risk of surgery may outweigh the risk of a device malfunction.

“This is likely to be the best choice for the majority of patients,” the company advised physicians.

Defibrillator leads connect patients’ hearts to implanted defibrillators that send an electrical shock if it senses a life-threatening abnormal heart rhythm. A fractured lead can prevent the device from sending a lifesaving shock or cause painful, unnecessary shocks.

Roughly 268,000 of the Fidelis leads have been implanted in patients worldwide, according to the company.

The Food and Drug Administration has received 107 reports of patient deaths where the devices may have played a role. Most of those reports were not filed by physicians, Medtronic notes, but “by family members or attorneys with minimal supporting data.”

After reviewing 89 of those reports, an outside group of physicians assembled by Medtronic judged that 13 deaths may have been caused by problems with the wires.

In recent months, federal judges have thrown out thousands of patient lawsuits against Medtronic, ruling that federal regulations shield the company from lawsuits filed at the state level. Those decisions were based on a Supreme Court decision last year that the federal FDA is the final arbiter of medical device safety.

Democrats in Congress are currently working to pass legislation to overturn that decision.

Shares of Medtronic fell $1.03, or 3.6 percent, to $27.55 in after-hours trading.

Consumer group asks government to ban Avandia

Gordon Johnson — Thu, 30 Oct 2008 12:33:00 +0000

Date: 10/30/2008

WASHINGTON (AP) _ The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.

The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market.

It was the second setback in as many weeks for the GlaxoSmithKline medication, which at one time had shown great promise in reducing the blood sugar levels of people with Type 2 diabetes. Last week, the American Diabetes Association and a European counterpart jointly released updated treatment guidelines for doctors that pointedly recommended against using Avandia.

“The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities,” Public Citizen said in its petition. “Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.”

Avandia’s heart risks were brought to light two years ago in a medical journal article that reported a 43 percent higher risk of heart attacks among Avandia patients when compared with those taking other diabetes drugs. Although scientists are still debating a link between the drug and heart attacks, concerns about the medical evidence led to stronger warnings.

As a result, Avandia use dropped sharply but about a million U.S. patients still take it.

Public Citizen said its own research found 14 cases of liver failure associated with Avandia, 12 of which led to death. The petition also said Avandia predisposes some patients to eye problems, anemia and bone fractures.

Glaxo, in a statement, said it does not believe Avandia causes liver failure. The company said its own data shows the drug has a good safety record when it comes to liver problems. The company said the data on heart attacks is inconclusive and that Avandia is safe and effective, when used according to directions.

There was no immediate response from the FDA.

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On the Net:

Public Citizen Web site: http://www.citizen.org/

WHO: heart, infectious diseases, cancer kill most

Gordon Johnson — Mon, 27 Oct 2008 15:26:00 +0000

Date: 10/27/2008

By ELIANE ENGELER
Associated Press Writer

GENEVA (AP) _ Heart ailments, infectious diseases and cancer remain the world’s top three killers, the U.N. health agency said Monday.

Heart attacks and related problems are the top killer, claiming 29 percent of people who die each year, the World Health Organization said in a report on the global burden of disease. In second place, infectious diseases lead to 16.2 percent of worldwide deaths.

Cancer, in third, claims 12.6 percent of global deaths, said the 146-page report, which is based on death registration data from 112 countries and estimates where reporting is incomplete.

The figures are from 2004, the most recent records available on a wide scale, officials from WHO said. But the rankings are unchanged since 1990 when WHO first did a global check.

Colin Mathers, WHO expert and lead author of the report, said he believed infectious diseases used to be the leading killer 20 to 40 years ago, but that he did not have statistics to back it up.

Some 58.8 million people died worldwide in 2004, most of them over 60, the report said. Nearly one in five deaths was a child under 5.

The heart disease death rate was virtually unchanged from WHO’s previous study on death causes, based on 2002 figures.

The rate for infectious diseases dropped from 2002, when they accounted for 19.1 of the world’s deaths, partly because estimates for AIDS deaths were revised downward last year, said Mathers.

“Malaria deaths are also somewhat lower, and some of the other child causes have also come down a bit,” Mathers said, adding that the number of deaths from measles has dropped thanks to wider use of vaccination.

Women die more often from heart disease than men. The rate for females is 31.5 percent, and for males 26.8 percent, the report said.

Mathers said the percentage for women was higher because there were more women living at older ages than men.

But in general, men are more affected by heart diseases, he said.

“Men in many parts of the world have a higher risk,” he said, adding that they are more often overweight or obese, get insufficient physical activity and eat more fat and salt.

Filling out the top 12 causes of death are respiratory infections including pneumonia in fourth place, 7.2 percent; respiratory diseases, including asthma and allergies, 6.9 percent; accidental injuries and drownings, 6.6 percent; newborn health problems, 5.4 percent; digestive diseases, 3.5 percent; suicide, murder and conflict, 2.8 percent; neuropsychiatric disorders, 2.1 percent; diabetes, 1.9 percent; and maternal health problems related to pregnancy or birth 0.9 percent.

Dr. Ties Boerma, who heads the agency’s statistics department, said there is always a time delay in assembling such data from a number of countries.

“Countries have a backlog of two, three years in publicizing their own information,” he said.

In countries where no death registration data are available, the figures are taken from research studies, which take a few years to get published, Boerma said.

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On the Net:

http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/index.html