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By Julie Steenhuysen

CHICAGO, March 18 (Reuters) - Virtually all of the experts who wrote favorably about GlaxoSmithKline Plc's troubled diabetes drug Avandia had financial ties to drug makers, a finding that shows the need for reform of such relationships, U.S. researchers said on Thursday.
A team at the Mayo Clinic in Rochester, Minnesota, pored through more than 200 scientific studies and commentaries that offered positive opinions about the drug after a May 2007 study suggested Avandia significantly increased the risk of heart attacks.
They found that 94 percent of the authors who defended the drug, known generically as rosiglitazone, had ties to drug companies, and nearly half had financial ties that presented a conflict of interest.
"It was almost three to four times more likely that somebody who had a relationship with a pharmaceutical company had a favorable opinion about the medication," Dr Victor Montori of the Mayo Clinic, whose study appears in the British Medical Journal, said in a telephone interview.
Montori looked at the financial relationships of researchers who had ties with pharmaceutical companies in general, and particularly those who wrote about rosiglitazone or the rival drug pioglitazone, made by Takeda Pharmaceutical Co Ltd under the brand name Actos.
"If you were to look at the proportion of people with favorable opinions, 94 percent of them had a relationship with a pharmaceutical company," Montori said.
"If you were to look at the folks with an unfavorable opinion, 28 percent had a relationship with a pharmaceutical company," he said.

The team checked both disclosures in scientific papers that mentioned Avandia and other papers by the same authors.
About a quarter of those did not report that relationship in the paper that was about Avandia.
"If the public was directly looking at financial relationships in the studies of interest, that information will not be present in a fourth of those studies," Montori said.
The Mayo team's findings "underscore the need for further changes in disclosure procedures in order for the scientific record to be trusted," the researchers wrote.
Glaxo spokeswoman Mary Anne Rhyne defended the drug.
"Of the 202 publications reviewed by the authors, only 10 were original scientific research," she said in a statement.
"Many of the articles reviewed were opinion pieces -- editorials, commentaries or letters. It is important to note that the authors' conclusions do not impugn the validity of the scientific data," she said.
Montori said the results were essentially the same if the researcher had a relationship with the maker of Avandia or the competing drug Actos, although they looked harder at research on Avandia.
"The reason is, it seems, there is a large overlap in the investigators who write opinions about these drugs that are funded by both companies," he said.
Montori said it is not clear whether having financial ties to a drug company influences a researcher's opinion, or whether drug companies seek out investigators who already have a good opinion of their drug and fund their studies.
What is clear, he said, is that drug company ties do appear to influence scientific opinion about the safety of drugs, and this issue may play a role in the debate about a drug's safety.
Rhyne said Glaxo plans to disclose research payments made to healthcare professionals and their institutions starting in the first quarter of 2011. Those will cover payments made to U.S. researchers in 2010, then will be extended to researchers and institutions outside the United States.
Last month two U.S. senators released a report and internal documents from Food and Drug Administration safety reviewers who recommended pulling Avandia from the U.S. market.
The FDA is reviewing data on Avandia and plans to hold a public meeting in July to discuss the risks and benefits of the drug. Meanwhile, the agency says doctors and patients should continue to use Avandia as directed.
Glaxo last month said the scientific evidence did not establish that Avandia increased heart attack risks.
Sales of Avandia, which topped $3 billion in 2006, fell to $1.2 billion in 2009.
(Editing by Maggie Fox and Eric Beech) Keywords: DIABETES AVANDIA/

(julie.steenhuysen@thomsonreuters.com ; +1 312 408 8131)

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By Maggie Fox, Health and Science Editor

WASHINGTON, March 18 (Reuters) - U.S. regulators, drug companies, philanthropists and advocates announced a new alliance on Thursday to speed tuberculosis drugs to market, a day after cancer researchers and drugmakers launched a similar initiative.
The U.S. Food and Drug Administration said it will work with drug developers to help them through some of the requirements for testing drugs before they can win approval, with the goal of speeding trials and saving money.
"FDA is absolutely committed to working with partners to speed access to new, safe and highly effective treatments for TB, which continues to mutate and spread," FDA Commissioner Dr. Margaret Hamburg said in a statement.
The alliance, called the Critical Path to TB Drug Regimens or CPTR, will test potential combinations of new TB drugs from different companies as they are being developed -- an almost radical approach.
Companies rarely cooperate on having their drugs tested together and usually such combinations are devised by doctors in the field long after drugs are approved. The alliance said it can take as long as 24 years to get approval for new TB drug cocktails under this system.
The new approach echoes initiatives in the 1990s to help speed AIDS drugs to market. AIDS and TB must both be treated with combinations of drugs taken every day -- for months in the case of TB and for life in the case of AIDS.

Partners include the Global Alliance for TB Drug Development, the Critical Path Institute, the Bill & Melinda Gates Foundation, Johnson & Johnson, Sanofi-Aventis , Pfizer, AstraZeneca, GlaxoSmithKline, Bayer, Japan's Otsuka, Novartis, Sequella and Anacor Pharmaceuticals Inc.
"This type of collaboration between the public and the private sector is exactly what's needed to help speed the availability of a shorter and more effective treatment for TB," said Dr. Tachi Yamada, president of the global health program at the Gates Foundation.
"A successful drug combination regimen to fight TB could save millions of lives."

Tuberculosis killed 1.8 million people in 2008, or nearly 5,000 people a day. It is caused by the Mycobacterium tuberculosis bacteria. More than 2 billion people are infected.
TB can be cured with antibiotics but they must be taken daily for months to be effective. Because people do not always take the drugs as directed, multiple drug-resistant strains called MDR-TB have emerged.
The World Health Organization reported that MDR-TB killed 150,000 people in 2008 and infected 440,000 globally. The WHO said the numbers suggest the hard-to-treat infection is spreading and there is an urgent need for countries to set up labs to fight it.
"I've seen first hand the public health impact and personal tragedy of drug-resistant TB," Hamburg said.

"This creative approach mirrors FDA's own investments in innovative regulatory science that ensures the best new medical technologies -- including combination therapies -- reach patients as soon as possible."
"The CPTR initiative has the commitment of the FDA and regulatory authorities in Europe to help develop and validate improved, safe, and accurate regulatory pathways to test and register combination TB treatments," the group said.
"No single company or institution can do it alone," said Dr. Paul Stoffels of Johnson & Johnson.

(Editing by Chris Wilson) Keywords: TUBERCULOSIS DRUGS/ (Maggie.Fox@ThomsonReuters.com; Washington bureau newsroom 202-898-8492)

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LONDON, March 18 (Reuters) - Martin Mackay, Pfizer's President of PharmaTherapeutics Research & Development, tells Reuters:

WASHINGTON, March 18 (Reuters) - Novartis AG and Astellas Pharma eczema drugs may need their warning labels expanded after dozens of new reported cases of cancer and infection in children, U.S. Food and Drug Administration staff said in documents released on Thursday.
Agency scientists said 46 cancer cases and 71 infection cases have been reported in patients aged 16 and younger from 2004 to 2008 with Novartis' Elidel and Astellas' Protopic.
Both drugs -- also known as pimecrolimus and tacrolimus respectively -- already carry strong warnings about cancer and infection, but officials should consider expanding them to include the new post-marketing reports, they wrote.
The documents were released ahead of an FDA advisory meeting Monday to weigh potential safety concerns with a variety of drugs used in younger patients.

Additionally, other FDA staffers said the warning label for GlaxoSmithKline Plc's herpes drug Valtrex was "insufficient" for certain central nervous system side effects in children, although no other concerns were seen.
Another scientist noted concerns about the use of Pfizer Inc's antibiotic Zmax in pregnant women and the potential for it to cause stomach blockages in newborns.
The FDA will weigh the recommendations from its panel of outside advisers before taking any action.
It was not clear what staff reviewers thought about the weight-loss drug orlistat, marketed as Glaxo's Alli and Roche Holding AG's Xenical. No new safety concerns were seen with other drugs to be discussed at the meeting, FDA staff said. Those drugs include:

* L'Oreal sunscreen ingredient Anthelios 40
* DuPont imaging agent Cardiolite (technetium Tc-99)

* Sanofi-Aventis allergy drug Nasacort AQ (triamcinolone); five-disease vaccine Pentacel; diphtheria, tetanus and pertussis vaccine Daptacel
* Privately held Boehringer Ingelheim's HIV drug Viramune (nevirapine)
* Glaxo's rotavirus vaccine Rotarix; diphtheria, tetanus and pertussis vaccine Kinrix
(Editing by Dave Zimmerman) Keywords: FDA ECZEMA/ Keywords: FDA ECZEMA/

(Company news desk in Washington; +1 202 898 8400, washington.newsroom@thomsonreuters.com)

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