Take two pills and call me if there's a birth defect

A recent article in the NYT reported that two studies released in The New England Journal of Medicine claim that an antidepressant could potentially increase the risk of a baby being born with a birth defect, but, uh,  it's unlikely and "confined to a few rare defects."

Benedict Carey, author of the article, points out that the studies didn't have a good sampling to really prove that assertion:

"In both studies, researchers interviewed mothers of more than 9,500 infants with birth defects, including cleft palate and heart valve problems. They found that mothers who remember being on antidepressants like Zoloft, Paxil, or Prozac while pregnant were at no higher risk for most defects than a control group of women who said they had not taken antidepressants."

So what's it's sounding like for me is that researchers got a group of expecting moms together, basically said, "Hey, have you taken an antidepressant?" and the ones who said yes were placed in one control group and the ones who said no were placed in another. How reliable.

Having been part of a clinical trial for bipolar disorder, I know it's likely these women got paid for their participation in this study. (Most people do, from what I understand.) So some could essentially have lied in the hopes they could snag $100. It doesn't sound like these women agreed to have their past medical history released to researchers that could prove they've been on antidepressant medication, they could have just been like:

"Uh, yeah. I took the antidepressant with the happy little egg sad face thingy."

Doctor: "Zoloft?"

"Yeah, yeah! That one. It maketed me alllll better."

Remember – it's mothers who "remembered" being on antidepressants while pregnant, not medical histories that proved that they've at least been prescribed the medication.

One doctor, not involved in the research, had reservations about the so-called findings:

"These are important papers, but they don't close the questions of whether there are major effects" of these drugs on developing babies, said Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, who was not involved in the studies.

Despite the seemingly positive outcomes that "support doctors' assurances that antidepressants are not a major cause of serious physical problems in newborns," both studies uncovered some pretty serious – but considered rare – conditions.

"One of the studies, led by Carol Louik of Boston University and financed in part by the drug makers GlaxoSmithKline and Sanofi-Aventis, found that use of Paxil was associated with an increased risk of a rare heart defect, which the company had previously reported.

The other study, led by Sura Alwan of the University of British Columbia, found that use of antidepressants increased the risk of craniosynostosis, a condition in which the bones in the skull fuse prematurely. Rare gastric and neural tube defects may also be more common in babies exposed to the medication, the studies suggested."

But don't worry, pregnant moms – the risks are low, "appear remote, and confined to a few rare defects." So, hey, even if your baby DID develop a rare defect, at least it's rare! [sarcasm]

I'd take the chance of depression if it meant my baby had a better chance of being born healthy. I'm lucky – I couldn't take Lamictal if I got pregnant. I wish antidepressants would have the same instruction.

"Quetiapine comes from the root word 'quiet'"

[UPDATE: I had some funky issues with my table. It should be fixed now. Sorry about that.]

The first time I visited my psychiatrist for my initial evaluation, he gave me the option of choosing one of three medications: Seroquel, Lithium, or Lamictal. He handed me information about Seroquel and Lamictal. I did some research on both meds (lithium was out of the question because I don’t have time to get my blood checked constantly) and Lamictal sounded like a way better deal than Seroquel. I found mental health blog Furious Seasons (probably via The Trouble With Spikol) and read numerous posts on Seroquel’s adverse effects and all the good stuff AstraZeneca doesn’t tell anyone. From Philip Dawdy’s “Seroquel, The Bipolar Pill?” post, here’s what stood out to me:

“He told her that he didn’t think Seroquel worked benignly for patients and that the increased blood-sugar levels and cholesterol levels associated with its use were unacceptable to him. She broke out a recent paper which claimed that there were no metabolic syndrome problems with Seroquel.”

The post got me thinking. One of the materials I received from my psychiatrist was an article on how Seroquel seems to help the depressive part of bipolar disorder. He had a stack of these articles. My guess is not that he’s an overzealous reader of various newspapers but received the glowing article from – you got it! – a pharma rep. The article was taken from the August 2005 issue of Clinical Psychiatry News. (NOTE: I received the article in November 2006.)

Clinical Psychiatry News’ publication goals:

“Clinical Psychiatry News is an independent newspaper that provides the practicing psychiatrist with timely and relevant news and commentary about clinical developments in the field and about the impact of health care policy on the specialty and the physician’s practice.”

Good thing they didn’t say objectively.

I don’t know much about ClinPsych’s reputation and whether they are generally a good paper that reports things objectively. However, the article, “Atypical Quetiapine Appears Effective for Bipolar Depression,” reads like a press release. I’m not happy about receiving (practically) PR material from my doctor when trying to make an unbiased decision.

The article’s lede:

“The atypical antipsychotic quetiapine led to significantly greater reductions in bipolar depression than did placebo within the first week of treatment and throughout an 8-week randomized, controlled study of 511 patients, Andrew J. Cutler, M.D., said.”

Dr. Andrew CutlerDr. Cutler? Who IS Dr. Cutler? No research necessary; look no further than the article itself:

“The differences between the placebo group and each quetiapine group were significant at each weekly assessment, said Dr. Cutler of the University of South Florida, Tampa. He is a speaker and consultant for, and has received research grants from, the company that makes quetiapine: AstraZeneca.”

At least they disclosed his financial affiliations.

It is also worth noting that Dr. Cutler also founded a clinical research company, CORE Research, which runs many of the clinical trials that he’s involved in. CORE Research’s background details:

“CORE Research, Inc. is a private research company with three offices in the Central Florida area. CORE specializes in pharmaceutical research and psychopharmacology for mental illnesses such as Bipolar Disorder, Depression, Anxiety, Schizophrenia, Attention Deficit Disorder, and Insomnia.”

Private + Pharmaceutical research + Psychopharmacology = Funding from Big Pharma Companies

I sound like I’m touting some grand conspiracy theory. (OK, maybe I am.) CORE’s background bio makes the company sound objective and unaffiliated, which isn’t the case. If Dr. Cutler has “received research grants from” not only AstraZeneca, but other companies, it’s in his best interest to make sure that their pharmaceutical products turn out OK. Namely in the interest of AZ – remember: he’s a consultant for them.

How can I expect to make a decision about which medication to take (remember it’s between Lamictal and Seroquel now) based on promotional materials from pharm companies and – oh – an article touting the benefits of Seroquel with quotes only from the study’s lead author who is paid to say good things about the company’s products?

I didn’t.

Then how did I decide on Lamictal over Seroquel? Wikipedia‘s outline of each medication’s side effects, of course, in addition to other materials. (Don’t EVER overlook the Patient Safety Information of any medication. Unless you’re reading about the molecular structure – ignore that.)

Lamictal (lamotrigine) side effects Seroquel (quetiapine) side effects
Headaches Sedation
Insomnia Agitation
Insomnia Constipation
Major weight loss Memory problems (i.e. anterograde amnesia)
Blurred/double vision Headaches
Muscle aches Abnormal liver tests
Lack of coordination Dizziness
Sleepiness Upset stomach
Nausea Substantial weight gain
Vomiting Stuffy nose feeling
Rash (Stevens-Johnson syndrome) [uncommon in adults] Neuroleptic malignant syndrome [rare]
Binds to melanin-containing tissues (i.e. iris of the eye) Tardive dyskinesia [rare]
Diabetes [unclear]
Cataracts [possible]

Not that Lamictal’s side effects looked like a walk in the park, but considering that I’d already had awful trouble with weight gain on Paxil and Lexapro – nearly 50 lbs. – Seroquel was a serious no-go on my part. That and I don’t mind major weight loss from Lamictal. (Although I have been told Lamictal has no effect on weight.) Below is a copy of the article I received from my psychiatrist or you can just go and read the archived full text at Clinical Psychiatry News.

Quetiapine article

Lots of studying to do

I don’t know much about the CATIE study (haven’t researched it yet) but feel free to go to the FREE CATIE breakfast symposium near you.

From the site:

Objectives:
At the end of these educational activities, participants should be able to:

  • Differentiate the clinical outcomes among patients prescribed the various treatment modalities in the CATIE study.
  • Choose an efficacious medication that improves symptoms in patients with schizophrenia who have failed on previous treatments.
  • Choose a tolerable medication to improve compliance in patients with schizophrenia who have discontinued previous treatments.
  • Individualize treatment for patients with schizophrenia based on history of symptoms, ability to tolerate adverse effects, and comorbid illnesses.
  • Discuss the effectiveness of antipsychotic medications for schizophrenia in terms of efficacy, tolerability, and cost.

I’ve heard about the CATIE study from sites like Furious Seasons and Clinical Psychology and Psychiatry, but now that I know it deals with schizophrenia, I’m interested in learning more about it.

CashIn other news, I attended a Bipolar and Depression Support Group tonight and received a presentation from UPenn on a genetics study they are doing to study bipolar disorder. They need 4,000 volunteers with bipolar disorder to help and they currently only have 2,000. If a person qualifies for the study, he or she will receive a $100 compensation. The study closes in December 2007. The following is some more information:

  • Individuals 16 and older with Bipolar I Disorder or Schizo-affective Diorder, Bipolar Type, are eligible to join this study.
  • Participation involves the following:
  1. Completion of questions
  2. A 1-2 hour interview (in person or over the phone)
  3. Small blood sample (drawn at UPenn’s expense)
  4. $100 compensation
  • The study does not change your treatment.
  • No travel required.

I can’t stress enough that people will bipolar disorder should participate in the study. Again, people do NOT need to live in the Philadelphia or Pennsylvania area to participate. People with bipolar disorder who live ANYWHERE in the United States can participate in the study. Please, let’s help make this study a success to improve treatment – not only for ourselves but also for future generations.