It can sometimes be tough to get a straight answer about any potential problems with drugs from the companies that make them, if court records are any guide. AstraZeneca (AZN) told American doctors the company's antipsychotic drug Seroquel didn't cause diabetes, despite alerting Japanese physicians to such a link four years earlier, according to court documents unsealed at the request of Bloomberg News.
AstraZeneca now faces lawsuits from more than 15,000 patients saying the company withheld information about links between diabetes and Seroquel. The lawsuits also say the Anglo-Swedish drugmaker promoted Seroquel, approved by the U.S. Food and Drug Administration for schizophrenia and bipolar disorder, for unapproved uses. The cases have been consolidated in Orlando for pre-trial proceedings. That drug reps are often less than comprehensive about disclosing the potential risks of their drugs is often more the norm than the exception, highlighting an unfortunate reality about how drugs are sold and ultimately prescribed to patients.
The AstraZeneca issues came to light after Bloomberg News filed a motion to gain access to company files turned over in Seroquel litigation. That prompted a federal judge to order AstraZeneca to unseal the sales-call notes by Sept. 11, but allowed withholding of physicians' names.
Several incidents from 2005 and 2006 have been discovered in the notes, Jef Feeley and Margaret Cronin Fisk of Bloomberg report. In one of them, for example, an AstraZeneca saleswoman met with a doctor who was told by patients about the drug's diabetes links. She told the doctor there was no "causative effect" found between Seroquel and diabetes, thus affecting his decision on continuing to prescribe the drug.
The behavior of the salespersons, according to Bloomberg, stems from training received on how "to deflect questions about links between weight gain and the drug," and how to "neutralize any questions associated with" Seroquel and weight.
That's despite the fact that already in 2002, the company warned Japanese physicians about dozens of of diabetes-related cases tied to Seroquel that seemed more than just chance, the documents show. In Japan, officials warned against prescribing Seroquel to diabetics in 2002. They also recommended that Seroquel users monitor blood-sugar level. AstraZeneca didn't start warning U.S. doctors to monitor blood-glucose levels until January 2004.
Though approved only for schizophrenia and bipolar disorder, relatively rare mental illnesses, Seroquel generated sales of $4.45 billion in 2008 -- and is the company's second-biggest seller after the ulcer treatment Nexium -- as it is prescribed for many other conditions as well.
Tony Jewell, an AstraZeneca spokesman, says in an email that the plaintiff claims are unproven. "The heart of these cases are unproven claims that Seroquel caused diabetes in individual patients," Jewell writes. "In the cases prepared for trial to date, plaintiffs have been repeatedly unable to prove their claims in a court."
He adds that AstraZeneca urges people to look at the data "fully and fairly," saying that material was taken out of context. He adds that "AstraZeneca works to improve patient health by helping ensure healthcare professionals are knowledgeable about our products and patient assistance programs, and by providing healthcare professionals with timely, relevant information that enables them to make the best treatment decisions for their patients."
The drug label contained information about a possible link between Seroquel-related weight gain and diabetes, as AstraZeneca points out, but the lawyers for the patients claim the London-based drugmaker downplayed such ties to protect sales.
The sales reps notes also show a practice of compensating doctors in different ways to affect sales, including paying doctors for speaking engagements and arranging upscale events. Most pharmaceuticals use these practice which have a direct effect on the number of prescriptions, according to an ex-Pfizer (PFE) sales representative interviewed by Bloomberg. Of course, doctors often seem to be only too-willing participants and "complained if they weren't forthcoming, the notes show."
Bloomberg provides several sales rep notes. In April, Kris Hundley, a St. Petersburg Times staff writer, published some of the earlier documents disclosed by AstraZeneca. The relationship between drug reps and doctors as described in the notes is astonishing, and could add to the public's suspicion of pharmaceuticals and doctors alike.
It also gives perhaps the most support to the Physician Payments Sunshine Act introduced in January by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) that requires pharmaceuticals (among others) to report on any payments over $100 to physicians and physician-owned entities including gifts, honoraria, travel and more. The act has been incorporated into the healthcare reform bill by Sen. Max Baucus where payments of over $10, or aggregate payments of over $100, will have to be reported.
It also seems that with time, these practices have been improving and even fading altogether, with more drug companies voluntarily stopping some of them. For example, Johnson & Johnson (JNJ) announced its support for the Physician Payments Sunshine Act of 2009 (S. 301). GlaxoSmithKline (GSK) announced this week changes in the way it pays for physician-training sessions and in other practices criticized by industry watchers. It will also begin publicly disclosing all payments it makes to doctors. It is banning corporate political contributions, too. That's in addition to previous changes. Similarly, Eli Lilly (LLY), Pfizer, Merck (MRK) and Medtronic (MDT) have all announced either policy changes or more transparency (Lilly, Medtronic, Pfizer, Merck).
The other side of the equation is the doctors, who also need better awareness regarding the effect such practices have on their own behavior and decision-making.
While more needs to be done, it seems there's a good beginning to changing this aspect of the industry.
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