Bupropion and teenage smokers


Author: Elio F. Gagliano, MD
Article Published: 30/11/2007


Once upon a time, when amongst fellow doctors one would refer a medically interesting finding or article, it was enough to say where one had read it to get, or fail to get, attention.

That is, some medical journals were recognized worldwide as being strictly scientific, and the studies they published were part of a doctor's continuing medical education. As time went by, things changed: many medical journals started printing works of scarce scientific value, either for the need of filling up pages, or to serve their patrons: the pharmaceutical companies. The latter hypothesis seems to me more accurate.

In Medscape Medical News of November 9, 2007 (article link) L. Barclay and P. Murata reported of a study regarding teenagers' smoking published in Archives of Pediatric & Adolescent Medicine. This is one of the oldest and most authoritative journals in US pediatric literature. I imagined the article would be worthwhile so I read it. Then I re-read it because I thought I had missed something. After the second reading, I asked myself, why had they published this? If I were one of the authors (Myra L. Muramoto and Scott J. Leischow of the University of Arizona) I would have refused to put my name on it. Prepare to shake your head at this:

 

The study was conducted to “compare the efficacy and safety of sustained-release bupropion HCl at 150 and 300 mg/day in the treatment of smoking cessation in adolescents”.

 

For this purpose, they selected 312 adolescents, aged 14 to 17 years, who “were  randomized to receive sustained-release bupropion HCl at 150 mg/day (n = 105), 300 mg/day (n = 104), or placebo (n = 103) for 6 weeks, plus weekly brief individual counseling.

 

Participants were followed up at 12 weeks (by telephone call) and at 26 weeks”.

 

When the 26th week came by, confirmed point prevalence abstinence rates were 10.3% with placebo, 3.1% with bupropion at 150 mg, and 13.9% with bupropion at 300 mg.

As the matter stands, the "Nothing" (placebo) worked better than the 150 mg bupropion. whereas the 300mg bupropion group showed 3 abstentious kids more than the  placebo group (13.9% vs. 10.3%)!

Isn't all this hilarious?

Do such results, medically and ethically, justify the exposing of youngsters to the risks of the drug's side effects which, besides headache, constipation, dry mouth, nausea, dizziness, insomnia, tremor, tinnitus. arthralgia, and myalgia, also include psychosis, confusion, and other neuropsychiatric disorders ranging up to suicide?

The failure of such a study was also obvious during the period of valuation as they were forced to "adjust for recruitment changes" during the "prolonged accrual period" (from March 1, 1999, through December 31, 2002).

 

Are such absurdities compatible with a scientific study?

 

To put the icing on the cake, there was "incomplete blinding because of the ability of study subjects to guess their treatment group".  Actually, it did not take much ability to do the guessing: those who were receiving the bupropion, one way or another, were suffering some side effects, whereas those in the placebo group were not. As a matter of fact, the medscape reportage is followed by: “Study Highlights” where, among other things, it is said:

 

"Bupropion vs placebo groups were more likely to have a headache or cough."

 

"Highlights" also include a "deliberate Jimson weed ingestion and a suicide attempt."

So I wondered and so may you: why was this paper published? The answer is in the title:

“Bupropion, Brief Counseling May Help Stop Smoking in the Short Term”

Doesn't the majority of people limit their reading to the titles? Here is the message: Bupropion stops smoking. That is what people will remember.

In concluding, I have to admit, I got a kick out of the last item amongst the "Highlights": "1 medically important event occurred in a placebo subject who became pregnant." I figured that she was feeling good and replaced the cigarettes with something else ...

P.S.: The reader may find it interesting to know: 

  • that the National Cancer Institute supported this study, along with the Robert Wood Johnson Foundation and GlaxoSmithKline, the maker of bupropion
  • that two of the study authors have disclosed various financial relationships with GlaxoSmithKline, Pfizer, and Sanofi-Aventis.
Elio F. Gagliano, MD




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