A forceful editorial by the St. Petersburg Times cuts through the Bull of "confidentiality" behind which pharmaceutical companies hide vital drug safety information.
The editorial is a follow-up to Kris Hundley’s report about AstraZeneca’s disingenuous arguments to keep documents detailing hazards linked to its’ antipsychotic drug, Seroquel, under seal.
The editors were not impressed with the company’s argument that keeping drug information secret was "for the public good."
The editors call upon the legal system to "put public health–and a patient’s right to know–above a company’s interest in secrecy."
"What the company really means is that disclosure could make drug consumers more aware of any downside risks of taking Seroquel — which might take a bite out of revenues."
And the editorial chides judges to put themselves in the shoes of an ordinary citizen who wants to know what there is to know about the effects of a drug:
"If the records being held back contain information that the judge would like to know before taking Seroquel, then the public should know as well. No other interest should take precedence."
posted by Vera Hassner Sharav
Tuesday, February 17, 2009
The company is claiming public safety, saying it shouldn’t be required to release information about the drug that could cause a panic among "a vulnerable patient population" that might stop taking the drug without a doctor’s oversight. But the real public safety issue is one of public health and whether the company hid findings that Seroquel causes weight gain and diabetes. The legal system must put public health — and a patient’s right to know — above a company’s interest in secrecy.
Seroquel has been approved for treatment of schizophrenia and bipolar disorder, but the drug is widely prescribed for other health problems such as depression and insomnia. Last year, this blockbuster drug racked up $4.5 billion in sales and was prescribed to more than 22 million people.
But there have been serious questions about potential side effects. AstraZeneca is facing more than 9,000 personal injury lawsuits filed by at least 15,000 patients. Forty percent of these cases have been consolidated in federal court in Orlando.
The lawyers for patients say that AstraZeneca knew for nearly a decade that Seroquel caused weight gain and diabetes. As Times staff writer Kris Hundley reported Sunday, a hearing is scheduled for Feb. 26 on the public disclosure of documents produced during the trial’s discovery phase, including unpublished results of drug studies and notes of company sales representatives on marketing strategies.
The plaintiffs’ lawyers want the court to unseal the documents. AstraZeneca wants the seal to remain and the hearing to be closed to the public. The company claims that disclosure could jeopardize public safety by causing "confusion and alarm" and prompting patients to end treatment.
What the company really means is that disclosure could make drug consumers more aware of any downside risks of taking Seroquel — which might take a bite out of revenues.
It would not be the first time a drug company is suspected of putting profits before public health. Internal documents on the Eli Lilly drug Zyprexa, also an antipsychotic, indicated that the drugmaker ignored evidence that its drug was causing weight gain and diabetes. Those documents were put under seal, and had it not been for an expert witness who disseminated them against court orders, the public may never have been sufficiently warned. Since then Lilly pleaded guilty to marketing Zyprexa illegally and paid a record $1.4 billion in fines.
AstraZeneca points out it won its first two cases, with the judge finding that the patients had not successfully linked their health problems to Seroquel. That doesn’t lessen the public’s interest in the results of clinical trials and what the company’s sales representatives were saying about the drug.
There is altogether too much secrecy in court cases that implicate public health. If the records being held back contain information that the judge would like to know before taking Seroquel, then the public should know as well. No other interest should take precedence.