2009 신종플루 대유행으로 막대한 수익을 올렸던 다국적 거대 제약회사 글락소스미스클라인(GlaxoSmithKline)이 11년 동안 당뇨병 치료제 아반디아( Avandia)의 심장에 대한 부작용을 알고도 숨겨왔다는 사실이 폭로되었습니다. 이 약품을 승인한 미 FDA도 책임에서 벗어나기 힘들 것입니다.
아반디아는 2009년 GSK 총매출의 1.57%를 차지한 블록 버스터입니다. 아반디아는 2000년부터 안전성 논란이 제기되어 왔습니다.
오늘자 로이터통신의 보도에 따르면, GSK는 4억6천만$를 지불하고 이번 소송들을 해결하기로 동의했다고 하는군요. 1만건의 소송이 제기되었는데 1인당 평균 4천6백$를 배상할 것이라고 합니다.
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Glaxo covered up diabetes drug’s risks: US lawmakers
출처 : AFP Tue Jul 13, 3:46 pm ET
http://news.yahoo.com/s/afp/20100713/hl_afp/ushealthdiabetespharma_20100713194722
WASHINGTON (AFP) – British pharmaceutical giant GlaxoSmithKline hid the dangers of its top-selling diabetes drug Avandia and secretly wrote scientific articles about it, two US lawmakers charged Tuesday.
The allegations came as the Food and Drug Administration (FDA) opened a two-day meeting of experts who will weigh whether to pull Avandia from the market over safety concerns.
In a letter dated Monday and addressed to FDA Commissioner Margaret Hamburg, Senators Max Baucus and Charles Grassley accused Glaxo of covering up scientific studies that found problems with Avandia and of including the drug in a “ghostwriting” program.
Baucus chairs the Senate Finance Committee and Grassley is a ranking member on the committee, which counts oversight of the FDA among its key tasks.
Their letter to Hamburg cited several Glaxo internal emails which show that the pharmaceutical giant knew that studies had found “problems” with Avandia but ordered that the findings not be made public.
Several studies have linked Avandia to an increased risk of heart attack and stroke, but a Glaxo-funded study last year came up with the opposite result.
Some of the Glaxo emails date back to 2000, a year after the diabetes drug was brought to market in the United States.
One of the studies, which showed that taking Avandia gave patients a worse lipid profile than ACTOS, a comparable diabetes drug made by a competitor, was withheld from the FDA’s attention, the letter says.
Higher lipids can contribute to an increased risk of heart attack or stroke.
According to an internal Glaxo email attached to the senators’ letter, Glaxo senior management requested that the results of the study “should not see the light of day to anyone outside of GSK.”
A note on whether to publish two further studies, which also found problems with Avandia, said bluntly, “Not a chance.”
Avandia is a money-spinner for Glaxo, racking up 800 million dollars in sales worldwide last year to make it one of the top-selling diabetes treatments in the world.
Glaxo included Avandia in a “sophisticated ghostwriting program” set up to promote some of its drugs, the US lawmakers alleged.
At least one article was ghostwritten by Glaxo on Avandia, attributed to a practicing medical doctor and published in a scientific journal
AFP saw copies of ghostwritten articles on Avandia and the internal Glaxo emails, which the lawmakers attached to the letter sent to Hamburg.
The lawmakers’ letter came as a panel of experts began considering whether Glaxo’s star diabetes drug should be pulled from the market.
“The documents we uncovered in our investigation will help arm the FDA with the best information possible as it evaluates Avandia’s safety,” Baucus said.
In a statement posted on its website, Glaxo said the documents were incomplete and misleading and “included drafts and documents taken out of context.
“GSK has been diligent in providing its safety data on Avandia to the FDA and in publishing its clinical trial data in peer-reviewed journals or on its clinical trial website,” the company said.
Data from the studies that drew the “not a chance” comment were, in fact, submitted to the FDA in 1999, Glaxo said, while the study that showed that Avandia-takers had worse lipid profiles than diabetics who used the competition’s drug was not even about Avandia and heart attacks.
As for ghostwritten articles, Glaxo said it “follows established authorship practices modelled after the International Committee of Medical Journal Editors guidelines.”
The FDA is not bound by recommendations made by the panels of experts it convenes to take a decision on a drug, but usually follows their advice.
Glaxo said to settle Avandia cases on eve of vote
Bloomberg, citing people familiar with the settlements, said the U.S. review was a factor in the decision by Glaxo officials to start negotiating with lawyers for former Avandia users.
It said Britain-based Glaxo would settle about 10,000 suits for an average of $46,000 each. A Glaxo spokeswoman declined to comment. Plaintiffs’ lawyers reached by Reuters also could not confirm a settlement.
Shares of Glaxo closed up 1.7 percent in New York trading, easily beating a 0.2 percent increase in the S&P pharmaceutical index.
Avandia’s U.S. sales were just 1.5 percent of Glaxo’s 2009 revenues, but investors fear withdrawal from the market could spark further patient lawsuits.
Scientific experts assembled by the FDA are holding a two-day meeting to sort through sharply conflicting data and opinions on whether Avandia causes heart attacks.
They are due to vote on Wednesday on recommendations ranging from ranging from keeping the drug on the market to recommending a withdrawal. Restrictions on use or beefing up a 2007 heart warning are among other choices.
Because the FDA asked panelists to select only one of the five options, there may be no clear majority.
The debate on Avandia’s safety has raged since warnings were placed on the drug in 2007 saying some research shows a link with a higher heart attack risk but the data is “inconclusive.”
Two U.S. senators released internal company documents on Tuesday they said showed Glaxo sought to downplay scientific findings about Avandia’s safety as far back as 2000, shortly after the drug was approved.
Added pressure on Avandia is coming from the European Medicines Agency, which has launched a new review into the drug’s risks and benefits.
DIVIDED FDA
FDA staff are deeply divided over the safety of Avandia, also known as rosiglitazone, and the agency has thrown the issue to the expert panel to untangle.
Dr. David Graham, an FDA reviewer who has pushed for Avandia’s withdrawal for years, said the agency applies different standards when deciding whether to approve a drug versus determining risk after a medicine is on the market.
Graham said the Record study relied on by Glaxo to show no increased heart attack risk from Avandia compared to older diabetes drugs would not pass muster for an approval. “You wouldn’t even hear about it because it’s garbage,” he said.
Dr. Ellis Unger, a deputy director of drug evaluation said he found Record’s results “pretty reassuring” on heart safety.
But he added it was up to the expert panel to decide if Record was legitimate.
“Can we trust the sponsor (Glaxo) with the results of Record? I think that is something the committee is going to need to think about,” Unger said.
Panelists asked some questions of Tuesday’s presenters but gave little hint on how they were leaning.
“It’s hard to say if GSK was helped or hurt by today’s events,” said Ira Loss, an analyst who follows the FDA for Washington Analysis.
GLAXO DEFENDS
Glaxo officials defended Avandia before the advisers saying diabetes was a serious disease that needed multiple treatment options to control blood sugar and prevent devastating complications including amputations and blindness.
“When used appropriately, (Avandia) has a positive benefit/risk profile and should remain a treatment for type 2 diabetes,” said Dr. Murray Stewart, a Glaxo vice president for drug research and development.
For the FDA, the case is seen as a test of how the agency will handle major controversies under Democratic President Barack Obama. Officials are facing heavy pressure from consumer groups and some lawmakers who say the FDA fumbled decisions in past administrations and failed to protect the public.
Some FDA staff see the Glaxo drug as more dangerous to the heart than Takeda Pharmaceutical Co’s rival diabetes pill, Actos, with no unique benefits.
An ongoing study comparing Avandia and Actos could provide a more definitive answer but critics argue it is wrong to wait years for those results. They say findings against Avandia are strong enough now to warrant the drug’s removal.
An outspoken critic, Dr. Steven Nissen, said there was enough evidence to conclude Actos was a safer option and Avandia offered no benefits over other diabetes drugs.
“Continued marketing of rosiglitazone cannot be medically or ethically justified,” said Nissen, head of cardiology at the Cleveland Clinic in Ohio.
Senate Finance Committee Chairman Max Baucus, a Democrat, and the committee’s top Republican, Charles Grassley, said they were very concerned Glaxo appeared to have failed to tell regulators about adverse findings in a timely manner.
Several documents released by the senators referred to a Glaxo study finding a potential heart advantage for Takeda’s Actos over Avandia.
Glaxo said the documents were being taken out of context and represented only a small percent of the documents provided to plaintiffs’ attorneys in Avandia product liability litigation.
(Reporting by Lisa Richwine; Editing by Tim Dobbyn)
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“제약업체 GSK, 당뇨치료제 위험 숨겨”
출처 : 연합뉴스 2010/07/14 04:49
http://www.yonhapnews.co.kr/bulletin/2010/07/14/0200000000AKR20100714005200072.HTML?did=1179m
(뉴욕=연합뉴스) 김지훈 특파원 = 제약업체 글락소스미스클라인(GSK)이 당뇨병 치료제인 아반디아의 부작용 위험성을 알고 있으면서도 이를 오랜 기간 숨겨온 것으로 드러났다고 뉴욕타임스(NYT)가 13일 보도했다.
이에 따르면 GSK의 전신인 스미스클라인 비챔은 1999년 가을 아반디아가 경쟁업체 다케다의 액토스보다 심장에 안전한지를 알아보기 위해 비밀리에 실험을 실시했다.
하지만, 실험결과 아반디아는 액토스보다 효능이 떨어질 뿐만 아니라 오히려 심장에 더 위험하다는 점이 분명히 드러났다.
NYT가 입수한 문서에 따르면 이 업체는 이런 실험결과를 공개하도록 규정한 관련 법규를 어기고 이를 11년간이나 은폐해왔던 것으로 드러났다.
아반디아의 심장질환 관련 위험성은 2007년 5월 한 의사가 공개한 연구결과에서 처음 공개됐는데, 이로부터 몇 달 뒤 GSK는 2005년부터 이 약품이 심장마비를 초래할 수 있다는 점을 알고 있었다고 인정했다.
그러나 최근 공개된 문서는 GSK가 1999년 아반디아 출시 직후부터 이 약이 광범위한 심장관련 질환을 초래할 가능성이 있다는 점을 알고 있었다는 것을 나타내주고 있다고 NYT는 지적했다.
또 다른 문서에 따르면 이런 아반디아의 위험성이 심화됐을 경우 GSK가 입게 될 매출 손실은 2002년부터 2004년까지만 6억달러에 달하는 것으로 추산됐다.
NYT는 미국 식품의약국(FDA) 내부에서 아반디아의 위험성에 대해 찬반양론이 있다고 지적하면서 FDA 관계자가 이런 내부의 논란을 GSK 측에 알려준 것으로 드러났다고 지적하기도 했다.
이에 대해 GSK의 대변인은 당시 실험 결과가 중요한 새로운 정보를 담고 있지 않았기 때문에 이를 공개하지 않았다면서 아반디아는 안전했었다고 주장했다.
hoonkim@yna.co.kr
