Cardiologists have accused a small drug company of withholding data from a clinical trial showing that the company’s drug, meant to reduce the risk of heart attacks, increased the risk instead.
The cardiologists said that the company, Anthera Pharmaceuticals, did not turn over data to academic investigators, as it was required to do, for more than a year.
“Despite a contract that required transfer to the academic authors, the company stonewalled every attempt to acquire the data,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said in an email on Tuesday.
Dr. Nissen was the senior author of a report on the data that was published online Monday by The Journal of the American Medical Association and presented at the annual meeting of the American Heart Association in Dallas. In unveiling the results there, the lead investigator, Dr. Stephen Nicholls, publicly admonished the company.
Dr. Colin Hislop, the chief medical officer at Anthera, denied the accusations, saying it simply took time to gather and organize the data. “I don’t think the timeline was particularly protracted, nor were we being difficult,” he said in an interview Tuesday.
Studies and lawsuits have shown that many clinical trial results, particularly negative ones, are not published. Critics say that hampers medical practice and violates an obligation to patients, who try experimental treatments in part to advance knowledge.
“We think that when you enter into a clinical trial, and we enter into contracts with our patients, there’s an obligation that we are going to do the right thing,” said Dr. Nicholls, a cardiologist at the South Australian Health and Medical Research Institute in Adelaide.
The Phase 3 trial involved 5,145 patients in various countries with acute coronary syndrome, a sudden blockage of blood flow to heart muscles. It tested whether the drug varespladib could reduce the risk of heart attacks, stroke, death and chest pains requiring hospitalization.
The trial was terminated early by the safety monitoring committee in March 2012. The company announced that the committee had determined that there was no chance the drug would succeed in the trial.
The results show that patients who got the drug actually had a higher risk of cardiovascular problems, mainly heart attacks, than those who received a placebo.
Dr. Nicholls said in an interview that Anthera continually promised to provide the complete data but did not. Finally, the company told him this spring that it had given the drug back to Eli Lilly, the original developer of the drug. The investigators were then able to get the data almost immediately from Lilly, he said.
Dr. Nicholls said that Anthera was also supposed to ensure that all patients were surveyed six months after the trial ended to see if they were still alive. But that data was collected for only 31 percent of the patients, making it impossible to clearly determine if the drug had increased the risk of death, he said.
Dr. Hislop of Anthera said the organization hired by the company to oversee the trial had tried vigorously to get that data. But some investigators, who were the ones who knew the patients’ identities, did not cooperate.
He said that because of the need to collect the six-month follow-up data, the study database was kept open until early this year. That was just before the company gave back the drug to Lilly.
Anthera, based in Hayward, Calif., was founded in 2004 and does not yet have a drug on the market. It is testing a treatment for lupus.
http://www.nytimes.com/2013/11/20/business/doctors-say-heart-drug-raised-risk-of-an-attack.html?_r=0
The cardiologists said that the company, Anthera Pharmaceuticals, did not turn over data to academic investigators, as it was required to do, for more than a year.
“Despite a contract that required transfer to the academic authors, the company stonewalled every attempt to acquire the data,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, said in an email on Tuesday.
Dr. Nissen was the senior author of a report on the data that was published online Monday by The Journal of the American Medical Association and presented at the annual meeting of the American Heart Association in Dallas. In unveiling the results there, the lead investigator, Dr. Stephen Nicholls, publicly admonished the company.
Dr. Colin Hislop, the chief medical officer at Anthera, denied the accusations, saying it simply took time to gather and organize the data. “I don’t think the timeline was particularly protracted, nor were we being difficult,” he said in an interview Tuesday.
Studies and lawsuits have shown that many clinical trial results, particularly negative ones, are not published. Critics say that hampers medical practice and violates an obligation to patients, who try experimental treatments in part to advance knowledge.
“We think that when you enter into a clinical trial, and we enter into contracts with our patients, there’s an obligation that we are going to do the right thing,” said Dr. Nicholls, a cardiologist at the South Australian Health and Medical Research Institute in Adelaide.
The Phase 3 trial involved 5,145 patients in various countries with acute coronary syndrome, a sudden blockage of blood flow to heart muscles. It tested whether the drug varespladib could reduce the risk of heart attacks, stroke, death and chest pains requiring hospitalization.
The trial was terminated early by the safety monitoring committee in March 2012. The company announced that the committee had determined that there was no chance the drug would succeed in the trial.
The results show that patients who got the drug actually had a higher risk of cardiovascular problems, mainly heart attacks, than those who received a placebo.
Dr. Nicholls said in an interview that Anthera continually promised to provide the complete data but did not. Finally, the company told him this spring that it had given the drug back to Eli Lilly, the original developer of the drug. The investigators were then able to get the data almost immediately from Lilly, he said.
Dr. Nicholls said that Anthera was also supposed to ensure that all patients were surveyed six months after the trial ended to see if they were still alive. But that data was collected for only 31 percent of the patients, making it impossible to clearly determine if the drug had increased the risk of death, he said.
Dr. Hislop of Anthera said the organization hired by the company to oversee the trial had tried vigorously to get that data. But some investigators, who were the ones who knew the patients’ identities, did not cooperate.
He said that because of the need to collect the six-month follow-up data, the study database was kept open until early this year. That was just before the company gave back the drug to Lilly.
Anthera, based in Hayward, Calif., was founded in 2004 and does not yet have a drug on the market. It is testing a treatment for lupus.
http://www.nytimes.com/2013/11/20/business/doctors-say-heart-drug-raised-risk-of-an-attack.html?_r=0
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