Anthera Pharmaceuticals, a Hayward, California drug company, has been accused of withholding results from an ineffective clinical trial. A drug that was supposed to decrease the risk of heart attack has instead made patients more susceptible to stroke and heart attack.
The data was published online in November and presented at the American Heart Association Scientific Sessions in Dallas.
Dr. Steven Nichols an Australian cardiologist and lead investigator, publicly rebuked Anthera, he stated that the company didn’t give researchers access to this information and also failed to follow up with the majority of patients, who may have been harmed by their drug.
Anthera Pharmaceuticals said to stonewall attempts to require trial data
When entering a clinical trial, physicians enter a contract with patients and have an obligation to do the right thing, Dr. Nichols stressed. A year following the study’s end he data was received, despite having a contract that required this information to be given to the academic authors.
A Cleveland Clinic cardiologist, Dr. Steven Nissen, said in an email that Anthera “stonewalled every attempt to acquire the data.”
Anthera Pharmaceuticals’ chief medical officer, Dr. Colin Hislop, denied the accusations and said he didn’t think the company was trying to be difficult, but that it just took time to gather and organize all of the data.
No follow-up with trial patients
As Dr. Nicholls remarked, the company was also supposed to make sure that every patient who took part in the trial was surveyed six months after its culmination to find out if they were still alive.
Unfortunately, data was only collected for about a third of the patients which made it impossible to get a definite determination as to whether or not the drug actually increased the risk of death.
Hislop’s denial of wrongdoing conflicts with the alleged facts. Reportedly, Athera continually vowed to provide all of the data, but never did.
Ultimately, representatives told Nichols that the company had given the drug back to the original developer of the drug, Eli Lilly. At that point, those who were looking into the issue were immediately able to get the necessary data from Lilly.
Negative clinical trial results rarely published
Studies have shown many clinical trial results, especially those that are negative, are never published. Patient and watch dog groups are then forced to file lawsuits to get the information released which could hinder medical practice and violate patient obligations.