Avandia linked to Heart attacks

[Guest guest]

Many of us are diabetic and on Avandia - please discuss this with your

prescrbing doc:

Sandy r

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From CNN Health: Senate report links diabetes drug Avandia to heart

attacksFebruary 20, 2010 4:39 p.m. EST

GlaxoKline denies that its diabetes drug Avandia causes heart problems.

Avandia linked to heart disease, Senate committee report says

GlaxoKline tried to hide risks from public, according to report

Company rejects reports conclusions, denies its drug causes heart problems

FDA " too cozy " with drug manufacturers, report says

(CNN) -- The diabetes drug Avandia is linked with tens of thousands of heart

attacks, and drugmaker GlaxoKline knew of the risks for years but worked to

keep them from the public, according to a Senate committee report released

Saturday.

The 334-page report by the Senate Finance Committee also criticized the Food and

Drug Administration, saying that the federal agency that regulates food, tobacco

and medications overlooked or overrode safety concerns found by its staff.

" Americans have a right to know there are serious health risks associated with

Avandia and GlaxoKline had a responsibility to tell them, " said U.S.

Senator Max Baucus, a Democrat and committee chairman. " Patients trust drug

companies with their health and their lives and GlaxoKline abused that

trust. "

The bipartisan report also was signed by Sen. Chuck Grassley, the top-ranking

Republican on the committee.

GlaxoKline rejected any assertions Saturday that the drug is not safe.

" We disagree with the conclusions in the report, " company spokeswoman

Pekarek told CNN. " The FDA had reviewed the data and concluded that the drug

should be on the market. "

Seven clinical trials on the drug prove that it is not linked to heart attacks,

Pekarek said.

" None of that data shows a statistically significant correlation between Avandia

and myocardial ischemia or myocardial infarction [heart attack], " she said.

Ischemia is a condition in which blood flow and oxygen are blocked from going to

certain parts of the body.

The Senate committee investigation stems from concerns that Avandia and other

high-profile drugs put " public safety at risk because the FDA has been too cozy

with drug makers and has been regularly outmaneuvered by companies that have a

financial interest in downplaying or under-exploring potential safety risks, "

the report states.

FDA Commissioner Margaret Hamburg said she is waiting for the recommendations of

an advisory committee that will hear reports on the drug this summer.

" Meanwhile, " Hamburg said in a statement, " I am reviewing the inquiry made by

Senators Baucus and Grassley and I am reaching out to ensure that I have a

complete understanding and awareness of all of the data and issues involved. "

The Senate report was developed over the past two years by committee

investigators who reviewed more than 250,000 pages of documents provided by

GlaxoKline, the FDA and several research institutes. Committee

investigators also conducted numerous interviews and phone calls with

GlaxoKline, the FDA and anonymous whistleblowers.

According to the Senate report:

• FDA scientists estimated in July 2007 that Avandia was associated with

approximately 83,000 heart attacks since the drug came to market.

" Had GSK considered Avandia's potential increased cardiovascular risk more

seriously when the issue was first raised in 1999 ... some of these heart

attacks may have been avoided, " the report states.

• GlaxoKline undertook attempts to undermine information critical of

Avandia.

" GSK executives attempted to intimidate independent physicians, focused on

strategies to minimize or misrepresent findings that Avandia may increase

cardiovascular risk and sought ways to downplay findings that a competing drug

might reduce cardiovascular risk, " the report says.

As an example, committee investigators say they found that GlaxoKline

experts verified an outside study showing the cardiac problem, but the company

publicly attacked the findings as incorrect.

• Two FDA safety officials sounded a clear alarm in October 2008 writing, " There

is strong evidence that rosiglitazone [Avandia] confers an increased risk of

[heart attacks] and heart failure compared to pioglitazone [rival drug on

market]. " They concluded and trials comparing the two would be " unethical and

exploitive. " Yet, the trial is still under way, the senators say.

GlaxoKline counters that the Senate report relies on outdated information.

" In essence, the report is a compilation of information and events that took

place years ago, " spokeswoman Pekarek said. " There's no new data there. "

The FDA has evaluated at the drug, Pekarek said, and updated product labeling in

2007 to say information on Avandia's relationship to myocardial ischemia is

inconclusive.

" The FDA exists to ensure patient safety, " she said. " That is their purpose. "

In essence, the report is a compilation of information and events that took

place years ago. There's no new data there.

-- Pekarek , GlaxoKline spokeswoman

RELATED TOPICS

Avandia

GlaxoKline plc

Food and Drug Administration

U.S. Senate Committee on Finance

Avandia has been under scrutiny for years. The New England Journal of Medicine

called the drug's safety into question in 2007. The Journal of the American

Medical Association also questioned whether Avandia was safe in 2007.

" Among patients with impaired glucose tolerance or type 2 diabetes,

rosiglitazone use for at least 12 months is associated with a significantly

increased risk of myocardial infarction and heart failure, without a

significantly increased risk of cardiovascular mortality, " the AMA journal

wrote, adding that the " findings have potential regulatory and clinical

implications. "

" Regulatory agencies ought to re-evaluate whether rosiglitazone should be

allowed to remain on the market, " the report said. " Health plans and physicians

should not wait for regulatory actions. They should avoid using rosiglitazone in

patients with diabetes who are at risk of cardiovascular events, especially

since safer treatment alternatives are available. "

In 2007, an FDA panel recommended by a vote of 22-1 that Avandia should remain

on the market despite an analysis showing links to increased risk of heart

attack. The vote was not binding, but a suggestion to FDA regulators.

The panel also voted 20-3 at the same meeting in support of data that showed

Avandia increased the risk of cardiac ischemia in patients with the most common

type of diabetes.

The Senate report does not address the issue of whether Avandia should be

removed from the market.