Tag Archives: Seroquel

Ethics professor takes on clinical trials, marketing

Writing for Mother Jones, University of Minnesota medical ethics professor Carl Elliott digs into the Dan Markingson story first covered by St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto. Elliott works at the same institution as the physicians who who administered a Seroquel trial that the 26-year-old was enrolled in when he committed suicide.

Given his teaching field and institution, it’s not surprising that Elliot couldn’t stay away from the Markingson story.

…the more I examined the medical and court records, the more I became convinced that the problem was worse than the Pioneer Press had reported. The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.

Elliot goes after the idea that the new wave of anti-psychotics was any safer than its predecessors, then explains the clinical trial manipulations he says were used to claim they were.

From there, Elliot takes on the use of clinical trials for marketing purposes. Clinical trials can be dangerous, which is theoretically acceptable if they have the potential to advance medical care. But what if patients are just being exposed to those dangers in an effort to sell more drugs?

Investigation of drug-trial suicide earns award

For a story on ethical issues in a drug trial that may have contributed to a patient’s suicide, St. Paul Pioneer Press reporters Jeremy Olson and Paul Tosto earned the Minnesota Journalism Center’s Frank Premack Public Affairs Journalism Award for excellence in investigative or analytical reporting about public affairs in the Twin Cities metro area.

Through the eyes of grieving mother Mary Weiss, Tosto and Olson followed Dan Markingson’s schizophrenia diagnosis, his participation in a University of Minnesota clinical trial for AstraZeneca’s Seroquel and his eventual suicide in 2004. Markingson was diagnosed, treated and enrolled in the study by Dr. Stephen Olson, who also happened to be looking for hard-to-find patients with Markingson’s symptoms for the psychiatric drug trial he was running.

From the judges:

In this piece, Olson and Tosto reported for the first time on schizophrenia patient Dan Markingson’s death and the resulting lawsuit and probes. In the process, they pulled back the curtain on the rarely viewed world of industry-funded clinical research and the financial incentives that can compromise a doctor’s decision-making.

Premack judges in this category said: “Through the eyes of one patient, this story shed considerable light on the complicated and competing interests between the development and path to market of new drugs, funding needs of the University and the integrity of medical research. The judges are hopeful that the new ethics task force implemented at the U of M is resulting in changes in conflict of interest policies.”

Olson and Tosto said Markingson’s death also raised “questions about why the Institutional Review Board, the internal group charged with protecting people in university studies, didn’t intervene.” The reporters also used the the $782,000 paid by drug companies to the two psychiatrists overseeing Markingson’s trial (including $261,000 from AstraZeneca) to highlight national criticism of the conflict of interest inherent in pharmaceutical-company funding of clinical trials and questioned whether study staff would be willing to let the public know if something untoward occurred during a trial.

“Physicians face a difficult choice,” testified Dr. Greg Rosenthal, an Ohio eye specialist. “One path is to go along. With drug company money, you can increase your income, prestige, build your practice or fund a department, research or professorships. The middle ground is to simply look away. The hard choice is to fight back.”

Seroquel user asks for side-effect documents

Lawyers for a Vietnam veteran who is among the thousands of patients suing AstraZeneca over claims that Seroquel caused diabetes and other ailments have requested the release of confidential documents about the drug’s side effects, AP business writer Linda Johnson reports.

Lawyers obtained the documents in question during the discovery process, and say they contain “internal company analyses of safety data on Seroquel that the lawyers believe FDA staff and advisers have never seen.” The judge in the case has set late March deadlines for the consideration of related motions, deadlines which take into consideration an April 8 FDA hearing FDA on the safety of proposed additional uses of Seroquel.

Lawyers for Ted Baker, 60, of Bastrop, La., have asked New Jersey Superior Court Judge Jamie Happas to unseal 19 specific documents – out of roughly 2.85 million generated so far in the litigation – so that they can present them to the FDA advisory panel members at the hearing.

“We think it’s important that they have the benefit of what we have learned,” Ellen Relkin, one of Baker’s lawyers, told The Associated Press in an exclusive interview Wednesday. “What we believe the FDA does not have are internal memos where they analyze the studies (and state) their real opinions or concerns about the data.”

According to Johnson’s report, “plaintiffs lawyers believe the drug causes Type 2 diabetes through two mechanisms: stimulating appetite and significant weight gain, and by raising levels of blood sugar and cholesterol.”


Hearing over sealed Seroquel documents is tomorrow

Sealed Seroquel documents hearing is Thursday

A closely watched hearing will take place in a federal courtroom in Orlando, Fla., tomorrow [Thursday] over the extent to which AstraZeneca should be forced to divulge internal documents filed in connection with product-liability litigation over its Seroquel antipsychotic. About 6,000 lawsuits have been consolidated and allege the drugmaker failed to adequately disclose that the pill can cause serious weight gain and diabetes.

At issue is whether thousands of pages of material should be unsealed. Typically, numerous documents are sealed at the outset of such litigation under agreements between attorneys for defendants and plaintiffs, in part, to speed along the proceedings. Companies also seek to have documents sealed to avoid publicity, investigations and additional lawsuits.

But earlier this month, Bloomberg News filed a motion to have some of the Seroquel documents unsealed, citing “the public’s right of access to judicial documents.” An AstraZeneca spokesman told BusinessWeek that releasing incomplete information could create a public health risk. However, Bloomberg argued that concerns about health risks are among the very reasons the documents should be unsealed.

Not surprisingly, the controversy is drawing parallels to the litigation over Eli Lilly’s Zyprexa, another antipsychotic linked to serious weight gain and diabetes. However, the Zyprexa lawsuits yielded an unexpected ruckus when David Egilman, a Brown University professor and an expert witness for the plaintiffs, leaked sealed Lilly documents to the media (background here).

Meanwhile, the Seroquel case is generating interest for yet another reason – allegations of sexual impropriety. An AstraZeneca employee, who was responsible for the drug in the United States, allegedly cavorted with a Seroquel researcher in the United Kingdom and a ghostwriter in the United States, according to court documents. You can read more about that here.

Update: AstraZeneca lawyer Stephen McConnell announced at the hear that AstraZeneca would release the documents, according to AmericanLawyer.com.

14 meds used off label need further study

Researchers have assembled a list of 14 widely prescribed drugs they believe urgently need additional study to determine safety and effectiveness for off-label use. Their list, which specifically targets meds that are widely used off-label without proper scientific backing, include a number of popular antidepressants and antipsychotics. And the most common off-label use for six of the drugs was for bipolar disorder.

“Off-label prescribing means that we’re venturing into uncharted territory where we lack the usual level of evidence presented to the FDA that tells us these drugs are safe and effective,” Randall Stafford, associate professor of medicine at the Stanford Prevention Research Center, who is the senior author of the study, says in a statement. “This list of priority drugs might be a start for confronting the problem of off-label use with limited evidence.”

At the top of the list was AstraZeneca’s Seroquel antipsychotic, which was approved by the FDA to treat schizophrenia. Not only did this drug lead all others in its high rate of off-label uses with limited evidence (76 percent of all uses of the drug), the researchers say it raised additional concerns because of its high cost at $207 per prescription, heavy marketing and the presence of a “black-box” warning from the FDA.

The study, which appears in Pharmacotherapy, appears only days after an FDA advisory committee criticized the growing off-label use of antipsychotics in children and amid an investigation by a group of state Medicaid directors. The consortium is evaluating the use of the drugs in children on state Medicaid rolls to ensure they are properly prescribed. The growing use of the medicines has been driven partly by the sudden popularity of the diagnosis of pediatric bipolar disorder.