Published: June 13, 2013
The American Diabetes Association (ADA) is calling for makers of incretin therapies to release all of their data on the drugs in an effort to clarify whether they have adverse effects on the pancreas.
The ADA wants the companies to make available all patient-level data on their products for an independent review ”that could help settle the question of whether such therapies contribute to the development of pancreatitis or pancreatic cancer,” the organization said in a statement.
”People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment and care in consultation with their healthcare providers,” Robert Ratner, MD, chief scientific and medical officer of the ADA, said in a statement.
ADA said it will release a call for applications from academic and research organizations that can handle large experimental databases to conduct the studies.
The statement was released Monday, 2 days before the start of a two-day workshop with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI) looking at the relationship between diabetes and pancreatitis and pancreatic cancer.
Several drugmakers said they would cooperate with the ADA’s requests. In a joint statement, AstraZeneca and Bristol-Myers Squibb said they ”support the ADA’s initiative … and look forward to a discussion with the ADA about the logistics of its proposal.”
Merck’s chief medical officer, Michael Rosenblatt, said in a statement that his company is ”committed to participating in an independent review of our data, and will join the ADA in planning for such an initiative.”
Earlier in the week, the issue of unpublished and withheld data on incretin therapies was raised by an investigation by BMJ, which found that drugmakers have been holding back data on potentially harmful effects of the drug class.
”On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” Deborah Cohen, investigative editor for BMJ, wrote in the piece.
The issue of unpublished data being subdued by drug companies started snowballing with the launch of British physician Ben Goldacre’s AllTrials.net, which aims to be a repository for all data on all drugs available on the market.
June has been an intense month for diabetes therapies. In addition to the NIDDK-NCI workshop, the FDA held a 2-day meeting on rosiglitazone (Avandia), in which a panel voted to loosen certain restrictions on prescribing of the drug. Rosiglitazone is a thiazolidinedione (TZD) — not an incretin therapy — and the TZD class has struggled with its own risks, including cardiovascular and bone effects.
During the NIH meeting, a speaker synopsis for FDA epidemiologist Solomon Iyasu, MD, MPH, said the FDA is considering whether to run a study to disentangle pancreatic risks with incretin therapies. The agency said epidemiological studies that it had required ”provided conflicting results and do not provide reliable evidence to refute or support a causal link.”
The synopsis concluded that thorough evaluation of these drugs and their pancreatic risks ”will require adequately powered, long-term epidemiological studies.”
From www.medpagetoday.com
BMJ Examines Risks of Incretin Therapy
Published: June 12, 2013
Incretin mimetics may be more risky than previously thought, given that drug companies have held back data on their potentially harmful effects, says the BMJ.
As part of its open data initiative, the journal reviewed thousands of pages of regulatory documents obtained under freedom of information rules and found unpublished data pointing to unwanted proliferative or inflammatory pancreatic effects.
”On their own, the individual pieces of unpublished evidence may seem inconclusive, but when considered alongside other emerging and long-standing evidence, a worrying picture emerges, posing serious questions about the safety of this class of drug,” Deborah Cohen, Investigative Editor for BMJ, wrote in the piece, published online.
Cohen also reported that the companies have not done critical safety studies, nor have regulators requested them. And access to raw data that would have helped resolve doubts about the safety of these drugs has been denied, she wrote.
The report is a thorough timeline of incretin mimetic-related events, from the first hints of pancreatic risk being brought to the attention of U.S. and European regulators, to boxed warnings about pancreatitis, as well as the genesis of the work of UCLA’s Peter Butler, MD, and his subsequent ”crusade” against incretin therapies.
Cohen highlights the fact that three studies published this year have shown greater pancreatic risks with incretin therapies, including an analysis of health insurance data that found a higher risk of hospital admission for acute pancreatitis for patients taking exenatide (Byetta) or sitagliptin (Januvia) than other diabetes drugs, and an analysis of FDA data showing an increased risk of pancreatitis and pancreatic cancer in patients taking these drugs.
She also highlighted the recent announcements by both the FDA and European Medicines Agency that they would review Butler’s data on pancreatic changes seen in organ donors who’d been on the diabetes drugs.
”The evidence is fiercely contested, with manufacturers stoutly defending the safety of their products,” Cohen wrote.
In an accompanying editorial, BMJ Editor-in-Chief Fiona Godlee, MD, wrote that ”instead of engaging in open debate about legitimate and important scientific questions, the manufacturers have been unwilling to share their data. Meanwhile, patients and doctors have not been kept properly informed about the uncertainties surrounding these drugs.”
”The debate would be much easier to resolve if all the information was placed in the public domain so scientists, doctors, and, ultimately, patients could make up their own minds,” Godlee added.
The report was published ahead of an workshop — sponsored by the National Institute on Diabetes and Digestive and Kidney Diseases and the National Cancer Institute — on diabetes and pancreatic cancer, which will consider the role of incretin therapies in development of pancreatic ductal adenocarcinoma.
From www.medpagetoday.com
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