Archive for August, 2011

28
Aug

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28
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27
Aug

No major heart risk seen in new psoriasis drugs

Posted in Health Care  by GinaRichter on August 27th, 2011
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CHICAGO |
Tue Aug 23, 2011 4:30pm EDT

CHICAGO (Reuters) – A new, highly effective class of psoriasis drugs did not appear to raise the risk of heart problems in a review of published studies, but the analysis may not have been big enough to detect rare cases, U.S. researchers said.

Abbott Laboratories pulled its U.S. and European marketing applications for one of the drugs in January, known as briakinumab [ID:nN14150334], due to concerns raised by U.S. regulators.

The drug is part of a new class of treatments known as anti-IL-12/23 agents that have been shown to be highly effective at treating psoriasis, an autoimmune disease marked by well-defined patches of red raised skin.

Patients with severe psoriasis are already at increased risk of heart attacks, and doctors are worried the new treatments may increase this risk.

Abbott’s decision also raised concerns about Johnson & Johnson’s Stelara or ustekinumb, the first drug in the class to win marketing approval.

“We’re concerned about the apparent excess in cardiovascular events,” said Caitriona Ryan of the Baylor Research Institute in Dallas, whose study appears in the Journal of the American Medical Association on Tuesday.

Ryan and colleagues analyzed data from 22 randomized clinical trials of anti-IL-12/23 and anti-TNF drugs to treat chronic plaque psoriasis, the most common form of psoriasis.

The older drugs block tumor necrosis factor-alpha or TNF-alpha, a protein involved in inflammation. The newer drugs targets two different inflammatory proteins — interleukin 12 and interleukin 23.

Anti-TNF drugs in the study included Abbott’s Humira or adalimumab, Pfizer’s Enbrel or etanercept and Johnson & Johnson’s Remicade or infliximab.

Ryan’s team found that during the active portion of the clinical trials they reviewed, 10 out of the more than 3,179 patients who were treated with anti-IL-12/23 had a major cardiac event, such as a heart attack, stroke or death related to heart disease, compared with no heart problems in the 1,474 patients treated with a placebo.

Among patients treated with the older anti-TNF drugs, only 1 of the 3,858 patients had a major cardiac problem compared with 1 of the 1,812 patients treated with placebo.

Ryan told Reuters that although the study did not show a statistically significant increase in heart problems, it was likely not large enough to detect these rare events.

Dr. Christopher Ritchlin, a rheumatologist at the University of Rochester Medical Center, who has seen the findings but was not involved with the study, said the analysis does not ease his concerns about drugs in this class.

“There are some safety signals you are seeing in the treatment groups that are not in the placebo groups. I’m not saying there is a definite association, but there is smoke here,” he said.

Ryan said the work exposes flaws in the design of clinical trials, which are powered to show differences in the effectiveness of drugs, but not to identify rare safety problems.

What is needed, she said, is some form of regulatory oversight of drugs after they win marketing approval, beyond the current system in which individual companies submit reports to the U.S. Food and Drug Administration.

“We have to find a way of being able to systematically gather safety data for these agents after they are on the market,” Ryan said.

(Editing by Philip Barbara)

© 2011 REUTERS (www.reuters.com)

27
Aug

Baby research challenged in new report

Posted in Health Care  by GinaRichter on August 27th, 2011
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NEW YORK |
Tue Aug 23, 2011 5:16pm EDT

NEW YORK (Reuters Health) – Tests of medical treatments in babies vary markedly in quality, at least as judged by the reports that make it into scientific journals, researchers say.

That’s a problem, they assert, because trials that don’t follow rigorous scientific standards are more prone to bias that makes the results unreliable.

Ultimately, those results trickle down into patient care, dictating what drugs and devices doctors use to help ailing children, said Dr. Sara B. DeMauro, of The Children’s Hospital of Philadelphia, who worked on the findings.

“There is always the possibility that the authors did do something and then forgot to report it, but that’s less likely,” she told Reuters Health.

DeMauro and her colleagues rated 179 randomized controlled trials — the “gold standard” study design — published in six prestigious medical journals, including three that specialized in pediatric medicine and three general medical publications.

The researchers used 11 criteria from the Consolidated Standards of Reporting Trials (CONSORT) checklist, which is in wide use in the medical community.

Half of the reports fulfilled nine or fewer criteria, with less than a quarter meeting all of them.

In particular, there were problems with how participants were assigned to the active treatment or to a dummy or a standard treatment. And as many as 21 percent of the articles didn’t state what the trial aimed to test, the so-called primary outcome.

“Without a primary outcome, everything else is superfluous,” said DeMauro. “So when some authors are not even giving you a clear primary outcome, you have to question the whole study.”

The shortcomings were particularly clear at pediatric journals, such as Pediatrics, in which the new findings themselves are published. On the other hand, general medical journals such as the Journal of the American Medical Association and the New England Journal of Medicine did much better.

The new data add to mounting evidence of subpar reporting practices in the medical community, which in turn can make it hard to create treatment guidelines.

Earlier this year, for instance, German doctors looking to establish guidelines for how to treat bipolar disorder said they had to give up because the trials in medical journals were so skimpily reported that they didn’t know what results they could trust. (See Reuters Health story of Feb 9, 2011 at reut.rs/i0HART)

According to DeMauro, it’s time that all medical journals begin to require higher standards in the reports they publish. While most do recommend following the CONSORT guidelines, “it is not being enforced,” she said.

“When reporting a clinical trial, those criteria should be followed very strictly,” she added.

SOURCE: bit.ly/nLwCWR Pediatrics, online August 22, 2011.

© 2011 REUTERS (www.reuters.com)

27
Aug

Judge sets September hearing on cigarette ads

Posted in Health Care  by GinaRichter on August 27th, 2011
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WASHINGTON |
Tue Aug 23, 2011 1:22pm EDT

WASHINGTON (Reuters) – A U.S. judge on Tuesday set a September hearing on the tobacco industry’s request to block Food and Drug Administration requirements for new graphic labels and advertising that warn consumers about the risks of smoking.

Judge Richard Leon ordered a quick September 21 hearing on the industry’s request for a preliminary injunction, despite objections by the Obama administration, which argued that the companies would not suffer irreparable harm without it.

With the September hearing, Leon said he hoped to have a decision sometime in October. He warned the parties that he had a full calendar of trials over the next several months, making it harder to fit the tobacco case into his schedule.

Any decision by Leon is likely to be appealed.

Reynolds American Inc’s R.J. Reynolds unit, Lorillard Inc, Liggett Group LLC and Commonwealth Brands Inc, owned by Britain’s Imperial Tobacco Group Plc, sued the FDA over the labels, saying they are unconstitutional.

The labels are part of a 2009 law passed by Congress that requires color warnings on the cigarette packages and on printed advertising. The industry says the warnings, due to go into effect by September 2012, force them to “engage in anti-smoking advocacy” on the government’s behalf.

They argued they need a quick ruling because they would have to start in November or December and spend millions of dollars to comply with the requirements. Justice Department attorneys said the money was a small fraction of the companies’ net sales.

The case is R.J. Reynolds Tobacco Co et al v. FDA, U.S. District Court, District of Columbia, No. 11-01482.

(Reporting by Jeremy Pelofsky and Anna Yukhananov; Editing by Steve Orlofsky)

© 2011 REUTERS (www.reuters.com)

27
Aug

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Posted in Health Care  by GinaRichter on August 27th, 2011
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