The reanalysis of all of the original raw data provided by GSK found no evidence that Paxil was effective for the treatment of major depression in teens. In fact, its effectiveness, both clinically and statistically, was right on par with placebo.
It also found that serious side effects such as suicidal tendencies were mislabeled and misrepresented. As it turns out, the elevated risk for suicidal ideation was only gleaned by digging into the actual patient files, where the exact nature of the behavior was recorded.
In terms of harms, the difference between Paxil and placebo was “striking,” according to the researchers.
Severe adverse events were 260 percent more frequent on Paxil compared to placebo, psychiatric adverse events were 400 percent more frequent, and suicide was 10,300 percent more frequent — during the eight-week long study, 11 individuals in the Paxil group engaged in suicidal behavior, compared to just one in the placebo group.
Reanalysis Reignites Call for Retraction of GSK’s Study 329
When Study 329 was originally published it received a lot of criticism, and calls for retraction have been made a number of times, citing both research flaws and ghostwriting, as well as undisclosed financial conflicts of interest.
In an accompanying article (14) to this new research, Peter Doshi, associate editor for The BMJ [British Medical Journal] notes that the original manuscript for Study 329 was written by a writer on GSK’s payroll — not any of the 22 named authors.
“It is often said that science self corrects. But for those who have been calling for a retraction of the Keller paper for many years, the system has failed,” Doshi writes.
“None of the paper’s 22 mostly academic university authors, nor the journal’s editors, nor the academic and professional institutions they belong to, have intervened to correct the record.
The paper remains without so much as an erratum, and none of its authors — many of whom are educators and prominent members of their respective professional societies — have been disciplined.”
Still, while the reanalysis has reignited calls for a retraction of Study 329, the authors have downplayed any wrongdoings of the original researchers, focusing instead on marshalling for greater transparency and data sharing to raise the scientific integrity of drug research.
Co-author Jon Jureidini told Time Magazine: (15) It’s not the point of this paper to humiliate GSK or to accuse anyone of fraud. It’s an attempt to honestly present the data. This is what the original paper should have looked like. If the original paper had reported things this way, there never would have been a problem.”
Barriers to Accurate Reporting of Harms in Drug Studies
The reanalysis has done more than simply reverse the original findings however. It also highlights the importance of making raw study data openly available for review and assessment by the scientific community.
Had this “double-check” analysis been done a decade ago, a lot of lives could have been spared. It might also have prevented the “contamination” of other studies. Study 329 has been cited in 334 other studies (16) — all noting of course that Paxil is effective and well tolerated.
It can be mindboggling to consider the snowball effect any given flawed study can have... Had Study 329 reported Paxil ineffective and unsafe, how might it have affected the conclusions of those other 334 studies?
The analysis was also able to identify a number of barriers that make it difficult to accurately report adverse side effects associated with drugs, and hopefully this will be able to help researchers improve the way these kinds of studies are done and analyzed in the future. The 10 potential barriers to accurate reporting of side effects include:
- Using an idiosyncratic coding system
- Filtering data on AE’s through statistical techniques
- Coding events under different headings for different
- Insufficient consideration of severity
- Masking effects of concomitant drugs
- Failing to transcribe all adverse events (AE) from clinical
record to AE database
- Restricting reporting to events that occurred above a
given frequency in one group
- Grouping events together
- Coding of relatedness to study medication
- Ignoring effects of drug withdrawal
When Crime Pays — the Case of Risperdal
Writing for The New York Times, (17) Nicholas Kristof recently addressed a similar situation in which a drug company made big bucks from a drug approved and marketed based on false information. The drug in this case is Risperdal, a billion-dollar antipsychotic that has been promoted to both young boys with autism and elderly dementia patients with devastating effects.
In the elderly, the drug is associated with stroke and subsequent death, and in boys it can promote the development of breasts. One young man was recently awarded $2.5 million in damages after the drug caused him to develop a 46DD bust. (18)
To be continued…
Sources and References:
(14) BMJ 2015;351:h4629
(15) Time September 16, 2015
(17) New York Times September 17, 2015
(18) Philly.com February 26, 2015
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Article Credit: Mercola, J. “Reanalysis Confirms Long Held Suspicions — Paxil Is Unsafe and Ineffective for Teens.” Mercola.com. Dr. Joseph Mercola, published 8 October 2015. Accessed 18 October 2015. <http://articles.mercola.com/sites/
Image Credit: U.S. National Library of Medicine, MedlinePlus. <https://www.nlm.nih.gov/medlineplus/antibiotics.html>. Published 30 October 2013. Accessed 18 October 2015.
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