Seroquel Study Results for Treating Mania and Depression in Bipolar Disorder Types I and II
AstraZeneca manufactures the drug Seroquel (quetiapine fumarate) and announced results of a 509 patient study at last week’s American Psychiatric Association meeting.
Seroquel is currently FDA approved for treating bipolar disorder I acute mania and schizophrenia. The announced study results looked at Seroquel to treat depression in bipolar types I and II patients, to confirm results of a prior study.
Seroquel is being positioned as treatment to both stabilize mood and relieve depression, to eliminate the need to use a mood stabilizing drug and an antidepressant. Having one less pill to take may help patients with bipolar disorder adhere to (stick to) their drug therapy.
Late last year, the company submitted a supplemental supplemental New Drug Application (sNDA) with the FDA for Seroquel in treating depression in bipolar disorder patients.
What I found interesting is the high response rate of the placebo (sugar pill) arms. At the end of the 2 month study (8 weeks):
60% of patients who took Seroquel at 300 mg/day responded
58% of patients who took Seroquel at 600 mg/day responded
45% of patients who took placebo responded.
It looks like a higher dose didn’t give a higher response rate, although higher doses of drug usually comes with higher percentage of side effects.
Caution: Seroquel should not be used in patients with dementia-related psychosis (usually elderly patients), and has also been associated with changes in body metabolism including hyperglycemia and ketoacidosis.
“Prozac Blues” Addresses Social Implications of Depression
A professor of Women’s Studies at Virginia Tech created a skit called Prozac Blues to tackle the social issues of depression around women’s roles and expectations.
Using those stories, Kilkelly and the other collaborators pulled from their own experiences and those of others to create a theatrical performance addressing issues surrounding depression and the use of prescription drugs to treat the illness. Through the use of images and small skits, “Prozac Blues” hopes to instigate discussion among the Blacksburg community on the issues surrounding the diagnosis of depression, gender differences of the illness and living with someone who is depressed.
In general, women are twice as likely as men to suffer from depression, and social factors that may contribute to propensity for women to become depressed may not be discounted. However, women may be seen as “just being emotional” when they talk about feeling depressed. While women’s roles have broadened, the expectations of women being “superwoman” - maintaining a career while nurturing a family with demonstrable success in both arenas - can create pressures. This may in turn lead to a reliance to prescription medications for different sorts of mental discomfort and disorders, and a skit called “Depression Jeopardy” as described in the article suggests the confusion around overlapping symptoms that many different psychotropic drugs are supposed to address.
ADHD Drug Debate
My guess is that Ms. Evelyn Pringle does not like the pharma industry because all her investigative reporting is about the evil-doings of pharma. When true, exposing wrongdoing is a good thing, since it will encourage companies to clean up their acts.
I’ll immediately admit that I have worked in the drug industry, have raised issues about some industry practices both when I was an employee and when I became a consultant, and currently work with drug companies as a consultant. For some, this may make me an automatically biased party. I don’t know if I need to argue against that, although I make a point to see both the positive and negative actions that the drug industry has incurred over the years.
In her opinion piece, “Just What Kids Need - Sparlon - Another ADHD Drug” Ms. Pringle does raise legitimate questions about the safety issues and drug trial designs for Cephalon’s drug. Additionally, any attempt on Cephalon’s part to sell the drug “off-label” is illegal and basis for these activities must be scrutinized and investigated. However, one of the experts she cited talked about the conflicts of interest of the authors in the drug trials. The expert said that the authors who did the research had so many affiliations with so many drug companies, “the large number of pharmaceutical company ties with the authors of the study do not lend confidence to the reader even beyond the aforementioned concerns.” I think this conclusion is misleading.
Here’s the fact: If you’re any good at what you do and are considered “influential” by your peers, there will be companies who desire your smarts and advice, and are willing to pay for your expertise. Most of us will think it’s fair exchange to get paid for our time and knowledge as well, which is provides the basis for “employment” or independent “consulting”. The drug industry is no different. It wants to have the best and the brightest physicians in their areas of study to work with the companies’ drugs and let the companies know whether the drugs are any good at all. Usually the best and the brightest physicians see drug companies as manufacturers of some of the most interesting compounds that they want to work with, which motivates many top researchers to reach out to drug companies to see if they can get their hands on the latest compounds in development. When conducted appropriately, this type of collaboration advances healthcare and can help patients who can benefit from the treatment. When conducted inappropriately, collaborations become a guise for kickbacks.
By saying that just because you’ve worked with 10 drug companies you must have sold your soul to drug companies and therefore are incapable of doing any honest science is misleading and an insult to some of these physicians’ reputation. In fact, some physicians make sure they work with multiple companies to ensure that they don’t look like they’re too loyal to just one company. Since most of these physicians care about their reputation (the top thought leaders usually are, being thought leaders and all), they are generally motivated to keep their scientific merit at the forefront of any collaboration - no matter which company.
Of course, there are bad eggs out there, as we have seen in all industries. We have greedy people and dishonest people and just-plain-evil people in our society. They infiltrate all industries including healthcare.
On the other hand, presenting information in a one-sided or biased manner so that you can sensationalize the issue serves few. Entertainment is fine but not at the expense of fair-balanced Patient Education.
Off My Soapbox: Dr. Ned talks about ADHD Meds or No Meds. The Drake Institute offers non-drug treatment options for ADHD. Politicians getting into the ADHD debate (PDF file). Daytona Beach News asks if kids are being overmedicated.