Glaxo Withheld Avandia Study, Ex-Regulator Said to Testify - Bloomberg

A former U.S. Food and Drug Administration official said GlaxoSmithKline Plc withheld from regulators a study showing its Avandia diabetes drug may cause heart attacks, according to two people familiar with her deposition in a lawsuit against the drugmaker.

Dr. Rosemary Johann-Liang, a former manager in the FDA’s drug-safety unit, told lawyers suing Glaxo that the 2001 study found Avandia posed a greater heart-attack risk than rival medicines, the people said. Glaxo also didn’t turn over an e- mail from researchers who concluded Avandia “strengthens the signals” of heart ailments, she testified in a pre-trial deposition last month, according to the people.

Johann-Liang left the FDA in 2007 following her recommendation that London-based Glaxo add more information about health risks to Avandia’s label, the people said. Johann- Liang stated that FDA officials provided the drugmaker with details of internal agency discussions about beefing up the warnings, according to the people, who also said she testified the leaks “should not have happened” and violated FDA policy.

Johann-Liang’s deposition may be considered by an FDA advisory panel meeting next week in Washington to consider whether Avandia’s ability to control blood-sugar levels outweighs a possible increase in heart attacks, strokes and deaths from cardiovascular disease, the people said. They declined to provide a transcript of the testimony.

No Proof

While Glaxo officials contend no studies have proven that Avandia is dangerous, drug-safety advocates have called for the medicine’s withdrawal from the market. Actos, a similar diabetes drug sold by Tokyo-based Takeda Pharmaceutical Co., poses less of a heart-attack risk, researchers have found. Glaxo withheld a study on Actos from the FDA, Johann-Liang testified, according to the people.

Glaxo disputes Johann-Liang’s claims that it didn’t turn over a 2001 review of Avandia’s health risks to federal regulators, Mary Anne Rhyne, a company spokeswoman, said in an e-mailed statement.

The company’s study “determined that there was no signal of an increased risk for heart attacks associated with Avandia,” Rhyne said. “GSK identified this internal review and described its results in a Periodic Safety Update Report that was submitted to the FDA.”

Full Disclosure

The company also has fully disclosed research findings on whether Avandia causes heart illnesses, such as thickening of the arteries, on the drug’s label since 1999, she said.

Erica Jefferson, an FDA spokeswoman, declined to comment beyond confirming that Johann-Liang isn’t currently an FDA employee. Johann-Liang didn’t return calls seeking comment.

Avandia was once the world’s best-selling diabetes pill, generating annual revenue of $3 billion by 2006, including sales of a combination pill called Avandamet. Sales plunged after a May 2007 report in the New England Journal of Medicine linked the drug to a 43 percent increased risk of heart attacks. That prompted U.S. and European regulators to order Glaxo to strengthen its warnings.

Glaxo, the U.K.’s biggest pharmaceutical company, faces about 13,000 lawsuits over Avandia and is in talks to resolve about half of them, two people familiar with the litigation said.

$1.1 Billion Liability

Glaxo agreed in May to pay about $60 million, or about $86,000 per case, to resolve 700 Avandia suits, the people said. Glaxo declined to comment on the settlements at the time.

The settlements suggest Glaxo faces a total liability of $1.1 billion over the drug, Gbola Amusa, a UBS AG analyst in London, wrote in a May 11 note to investors. Amusa and other analysts said earlier that the company might pay as much as $6 billion to resolve all Avandia litigation.

Glaxo set aside 2.3 billion pounds ($3.5 billion) for “legal and other disputes” as of the end of March, the company said April 28. It didn’t specifically mention litigation relating to Avandia.

Glaxo faces its first U.S. trial over Avandia in Philadelphia federal court in October, Rhyne said.

The people familiar with Johann-Liang’s deposition said her FDA unit, which oversaw the safety of drugs already approved for sale in the U.S., recommended in 2006 that labels for Avandia and Actos be upgraded to the highest level, with stronger warnings about the risk of heart failure listed in a black box.

17-Month Delay

FDA officials were upset with the recommendation and waited 17 months before implementing it, the people said. In the meantime, they took away her power to make such recommendations and excluded her from safety review meetings, the people said. Johann-Liang, a pediatrician, left the FDA in June 2007 after six years with the agency.

Johann-Liang gave her testimony to Joseph Zonies, a Denver- based lawyer who represents consumers alleging that Glaxo hid Avandia’s health risks, the people familiar with the deposition said. Glaxo’s lawyers were present during the deposition, they said. Zonies didn’t return calls for comment.

During the deposition, Zonies asked Johann-Liang whether she was pleased by the FDA’s decision to require the Avandia black-box warning she had recommended, the people familiar with the testimony said.

The doctor said she didn’t feel vindicated because “people taking this drug got hurt” in the time between her recommendation and the agency’s action, the people familiar with her testimony said.

In their Avandia suits, consumers contend Glaxo officials refuse to take the drug off the market even though studies have shown it poses an increased risk of heart attack and stroke compared with competing medicines.

Federal Suits

Federal lawsuits over the medicine are combined in federal court in Philadelphia. Glaxo’s U.S. operations are based in the Philadelphia area, with more than 5,000 employees in downtown offices and suburban research facilities.

A report by two U.S. senators in February said FDA regulators urged Glaxo to withdraw Avandia from the market in 2008 because it was causing 500 avoidable heart attacks a month. The report, by Senators Max Baucus, a Democrat from Montana, and Charles Grassley, a Republican from Iowa, also said Glaxo officials sought to intimidate doctors who criticized the drug.

Glaxo pressed medical researchers who observed the emergence of heart and liver problems in patients taking Avandia to stop disseminating their findings and contacted the doctors’ superiors in several cases, according to the report.

Key Data

Allan Sniderman, a cardiology professor at McGill University’s Health Center in Montreal, wrote the FDA last month saying he had key data about Avandia’s risks that should be presented to the advisory panel, said one of the people familiar with Johann-Liang’s testimony who provided Bloomberg News with a copy of the letter.

Because Sniderman has been hired as an expert witness in lawsuits over the drug, the data is covered by a confidentiality order, according to the letter. The doctor wrote that he is asking a judge to lift the order barring his testimony.

“My position allows me access to data that has not previously been available to any similar group considering these issues,” Sniderman wrote in the letter. He didn’t return calls seeking comment.

Rhyne said yesterday that Sniderman later withdrew his request to address the advisory committee before the judge decided whether to drop the confidentiality restrictions on his testimony.

The case is In Re Avandia Marketing, Sales Practices and Products Liability Litigation, 07-01871, U.S. District Court, Eastern District of Pennsylvania (Philadelphia).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware, at jfeeley@bloomberg.net and; Michelle Cortez in London at mcortez@bloomberg.net.

via bloomberg.com

Posted via email from Jack's posterous