| Date | Media | Topic |
|---|---|---|
| 2015-10-21 | Scientific American | Many Antidepressant Studies Found Tainted by Pharma Company Influence A review of studies that assess clinical antidepressants shows hidden conflicts of interest and financial ties to corporate drugmakers |
| 2015-10-21 | 1 Boring Old Man | some clarity?… Back in August, I sent this email out to a number of people.. |
| 2015-10-20 | Medscape | A New Look at an Old Study: How Do We Stop Data Spinning? In 2001, a pharmaceutical industry-conducted trial[1] published in the most prestigious American journal of child psychiatry reported that paroxetine was more effective than placebo in treating major depression in 275 adolescents. The study was conducted by the drug manufacturer in typical fashion: dozens of clinical sites were used throughout the country to recruit patients, the data were analyzed in-house by statistical employees of the company, and academic leaders in the field reviewed and revised the paper and became its authors, the first being the chairman of the department of psychiatry at Brown University ... |
| 2015-10-20 | David Healy | Study 329: Conflicts of Interest Email from Fiona Godlee (Editor of The BMJ) to RIAT July 6th 2015 Re: Study 329 Dear Dr Jureidini, |
| 2015-10-14 | Irish Examiner | Seroxat study ‘failed’ to report effects An antidepressant drug made here and commonly used by younger adults in Ireland and elsewhere may not be either as effective or as safe as originally believed. |
| 2015-10-13 | Student Science | Study challenges safety for teens of two depression drugs Scientists reanalyze older data on drugs’ safety and come to new, worrisome conclusions |
| 2015-10-13 | David Healy | Study 329 in Japan Editorial Note: By 2002 GlaxoSmithKline had done 3 studies in children who were depressed and described all three to FDA as negative. As an old post on Bob Fiddaman’s blog reproduced here outlines, several years later they undertook another study in children in Japan. |
| 2015-10-07 | David Healy | Study 329: By the Standards of the Time Editorial Note: This post by Johanna Ryan looks at an element of the defense offered by Neal Ryan and others, namely that by the standards of the time the authors of 329 weren’t doing much wrong. |
| 2015-10-05 | Wall Street Journal | How Much Should Scientists Check Other Scientists’ Work? A question is dividing the scientific community: Is there a value to public health in spending time and money to replicate long-completed, peer-reviewed studies? Two recent high-profile papers that scrutinize older research have raised questions about the fundamental reliability of scientific findings.. |
| 2015-10-02 | Psychiatric News | Will Paroxetine Controversy Change Clinical Practice? The findings of the recent BMJ study are unlikely to lead to changes in clinical practice, but do raise questions about psychiatric research, experts say. |
| 2015-09-30 | AAFP | Rehash of 2001 Study Finds Paroxetine, Imipramine Ineffective, Unsafe for Teens September 30, 2015 10:12 am Chris Crawford – The antidepressant paroxetine (Paxil, Pexeva) is ineffective and unsafe for treating adolescents with depression, according to a reanalysis(www.bmj.com) of a 2001 study that was published online in BMJ on Sept. 16. |
| 2015-09-30 | The Australian | Drug trial data should be released: Jon Jureidini All drug trials should be viewed sceptically until the underlying clinical data is published and checked, a University of Adelaide psychiatrist has warned. Jon Jureidini says the reason many medical trials cannot be replicated may not be because the experiments were mishandled, but because they were misinterpreted. |
| 2015-09-29 | 1 Boring Old Man | study 329 xii – premature hair loss… I was hoping to move away from the Study 329 paper for a while, mainly not to run the boring in 1boringoldman into the ground, but something came up today that I thought was in need of emphasizing. During the 2 years writing the paper, there were a number of subplots along the way. As it became apparent that the suicidality issue was even bigger than we had imagined, we began to wonder if the Sponsors/Doctors had told the afflicted kids or their parents that the suicidal thoughts may well have been caused by the medication itself. Dr Healy wrote about this on his blog recently [Study 329: MK, HK, SK, GSK & History]: |
| 2015-09-29 | Business Insider (Australia) | Researchers may not have reported an important side effect to an antidepressant drug used by teens (Reuters Health) — According to a reanalysis of the original data from a 2001 study of paroxetine (Paxil) for teens with major depression, the drug was not effective and led to serious side effects, which is not how the results were presented 14 years ago. |
| 2015-09-29 | International Business Times | New Paxil Warnings For Teens Prompt Fury From Former Patients Kaili Butin still has faint scars on her wrist from the day she tried to kill herself. A family physician had prescribed GlaxoSmithKline's antidepressant Paxil to treat her depression. It was the fall of 2000, her sophomore year of high school, and she had stopped caring about schoolwork and lost interest in her friends. |
| 2015-09-28 | K5 TV (Washington) | Ask Dr. Swanson: Is antidepressant Paxil safe for teens? Dr. Wendy Sue Swanson joined KING 5 to discuss a new study about the antidepressant Paxil. |
| 2015-09-28 | 1 Boring Old Man | study 329 xi – week 8… In study 329 ix – mystic statistics… I was talking about the variables reported ib the Keller et al paper that weren’t in the original protocol, the ones that were reported to be statistically significant. They’re highlighted in blue in this copy of their Table 2: |
| 2015-09-26 | David Healy | Study 329: MK, HK, SK, GSK & History In May 2014, the RIAT team asked GSK what the children who became suicidal in the course of Study 329 have since been told. (Marty Keller’s “take” on this is at the bottom). |
| 2015-09-25 | Asian Scientist | Antidepressant For Adolescents Was Misrepresented As Safe Revisiting clinical trial data has led investigators to conclude that not only was the antidepressant drug paroxetine is no better than the placebo, but it have may caused serious side effects including suicide. |
| 2015-09-22 | The Brown Daily Herald | Reanalysis of Paxil study sparks new round of criticism After more than a decade of controversy surrounding a 2001 clinical trial led by a Brown professor on the effects of the antidepressant Paxil, a reanalysis of the original data claims the drug is no more effective than a placebo and that the initial study underplayed the drug’s potential to increase suicidal thoughts among adolescents. |
| 2015-09-21 | Health Insight UK | Dose of Jeremy Corbyn needed to make medicines safe It’s generally agreed that the NHS is not in good health but there’s no clear diagnosis. There are plenty of suggestions – lack of funding, uncompassionate nurses or box-ticking managers. But I want to suggest another one: the crisis in evidence based medicine (EBM). |
| 2015-09-21 | IFL Science | Antidepressant Trial Failed To Mention Numerous Suicide Attempts Clinical notes from a trial of the antidepressant paroxetine, reported as finding it to be both safe and effective for adolescents, in fact showed the opposite, researchers have claimed. The largest re-examination of clinical data from a high profile trial has found a terrifyingly high rate of suicidal behavior that failed to be reported in the controversial study. The revelation could influence the prescription of similar drugs and will add to pressure to change the conduct of clinical drug trials, particularly for antidepressants. |
| 2015-09-21 | 1 Boring Old Man | lost its mojo… One might think that with all of the supportive media coverage our Study 329 article has received, I would be able to shake off the response from lead author, Martin Keller, reproduced from Retraction Watch in the last post [keller responds…], or his comment in The Chronicle of Higher Education: |
| 2015-09-21 | Post Bulletin | Why should it take 14 years to learn a drug's safety risks? How would you describe the behavior of a teenager who takes 80 tablets of of an over-the-counter medication that's deadly in high doses? Or an adolescent who had a disagreement with her mother, then overdoses on prescription pills? Or a child that had to be admitted to the hospital for severe suicidal and homicidal thinking? |
| 2015-09-20 | Boston Globe | Drug companies must share trial data, Paxil saga shows Some people can keep secrets much better than others. Among them are the folks who run the world’s biggest drug companies. For years, they have sequestered clinical trial data containing precious information about their medicines. But a recent development might accelerate efforts to bring about greater transparency. |
| 2015-09-18 | The Atlantic | The Human Cost of a Misleading Drug-Safety Study A reexamination of old data for Paxil found that the antidepressant is more dangerous than the authors let on. How much harm has been done in the 14 years since it was published? |
| 2015-09-18 | MINNPost | Re-examination of Paxil study underscores concerns about company-sponsored clinical trials A re-analysis of the 2001 study that led physicians to prescribe the antidepressant paroxetine (Paxil) to millions of adolescents has uncovered disturbing evidence that the study’s authors misrepresented the clinical trial’s data. |
| 2015-09-18 | Examiner.com | Reanalysis of 2001 study finds Paxil unsafe for teens Reanalysis of a 2001 drug trial that found the antidepressant paroxetine (brand name Paxil) was safe for use by teens contradicted the manufacturer’s claims. The new study, published Sept. 16 in the journal BMJ, found that the drug is “unsafe and ineffective” for treating major depression in children and adolescents and, in fact, can make some teens suicidal. |
| 2015-09-18 | Psych Central | Reanalysis Finds SSRI Paroxetine Ineffective for Depressed Teens The antidepressant drug paroxetine (Aropax, Paxil, Seroxat) has been found to be ineffective and riddled with disturbing side effects when used as a treatment for teens with depression, according to a reanalysis of an old drug trial led by researchers at the University of Adelaide. |
| 2015-09-18 | Exome | West Coast Bio Roundup It’s not specific to the West Coast, but anyone who needs to catch up on the week’s events should read the British Medical Journal’s re-analysis of a long-criticized study, dubbed Study 329, of the antidepressant paroxetine (Paxil) in an adolescent population. It took place in the 1990s, run by SmithKline Beecham (now GlaxoSmithKline). Paroxetine was approved for adults in the U.S. in 1992. |
| 2015-09-18 | Pulse | Paroxetine 'causes harm in adolescents', researchers claim Paroxetine in not effective in adolescents with major depression and actually causes harm, a reanalysis of a major study has revealed. |
| 2015-09-18 | The Times | Flawed trial led to ‘unsafe’ drugs for children Millions of young people were prescribed an antidepressant on the basis of a trial that should have concluded it was not safe or effective in children. |
| 2015-09-18 | Wall Street Hedge | Popular Antidepressant Paxil Dangerous for Teenagers The frequently recommended antidepressant Paxil (paroxetine) is actually powerless and unsafe for teenagers, a recent study has shown. This contradicts previous findings published in 2001 which had deemed the drug “generally well tolerated and effective”. |
| 2015-09-17 | Newsweek | Paxil Isn’t Safe for Teens, According to Reanalysis of Old Study The commonly prescribed antidepressant Paxil (paroxetine) is unsafe for teens, according to a new paper that reanalyzed data from a study published 14 years ago. The new paper, published Thursday in The BMJ (formerly British Medical Journal), contradicts the study’s original findings that the drug is “generally well tolerated and effective” for treating severe clinical depression in adolescents. |
| 2015-09-17 | International Business Times | Study 329: Antidepressant trial's upended results show need for sharing all data In 2001, a "landmark" study published in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry purported to show the safety and effectiveness of using a common antidepressant to treat adolescents. But soon after its publication, both researchers and journalists raised questions about the research. And in an article we published today in the BMJ, we've shown that the original published findings were biased and misleading. |
| 2015-09-17 | +AllTrials | New research on old data Many supporters of AllTrials will be interested in a study published in The BMJ today, a reanalysis of previously hidden clinical trial data. The new research used data from a 1990s clinical trial of the GlaxoSmithKline (GSK) antidepressant drug paroxetine. Today’s findings contradict a 14-year-old analysis of the data referred to as Study 329, which found paroxetine to be safe and effective for treating adolescents with major depression. |
| 2015-09-17 | 1 Boring Old Man | study 329 x – “it wasn’t sin – it was spin”… [Note: the Press coverage of our article is on st329.wpengine.com, but I wanted to mention the article on Retraction Watch because it has Dr. Martin Keller’s response to our paper with an argument similar to the one below…] We know from this internal memo and position piece that the initial SKB interpretation of the efficacy results from Study 329 mirrored those reported in our RIAT article: |
| 2015-09-17 | 1 Boring Old Man | study 329 ix – mystic statistics… Most of us have an incomplete knowledge of Statistical Analysis unless we’ve had formal training and hands-on experience, yet we tend to accept the output from the computer’s statistical packages as if it’s dogma. In academic and commercial laboratories, we count on Statisticians [or trained SAS Programmers] to generate those abstract lettered indices that we discuss as if they’re absolutes – p, d, k, SEM, SD, NNT, OR, etc. And even the experts can’t check things with a pad and pencil. So we’re vulnerable to subtle [and even not so subtle] deceptions. |
| 2015-09-17 | NHS choices | Antidepressant paroxetine study 'under-reported data on harms' "Seroxat [paroxetine] study under-reported harmful effects on young people, say scientists," The Guardian reports. Researchers have reanalysed data about the antidepressant paroxetine – no longer prescribed to young people – and claim important details were not made public. Researchers who looked at data from the now infamous 1990s "study 329" trial of the antidepressant paroxetine, found reports of suicide attempts that were not included in the original research paper. |
| 2015-09-17 | 1 Boring Old Man | study 329 viii – variable variables decoded… The 528 page Full study report acute is an exhaustive narrative of the entire study including the results in much more detail than the published article – filled with charts and tables. It was released in part by court order in 2004 and in full in 2012. The sections that relate to our questions about the changing outcome variables in the published paper are scattered around. The first reference is on page 44: |
| 2015-09-17 | Huffington Post | Popular Antidepressant Is 'Ineffective And Unsafe' For Young People, Researchers Say An early trial of the drug seems to have downplayed its scariest side effects. |
| 2015-09-17 | Scientific American | Analysis of Antidepressant Paxil Finds Data on Teen Risk Was Held Back Drugmaker GlaxoSmithKline is criticized for delaying access to data about its antidepressant paroxetine (Seroxat, Paxil) that would have shown earlier that it is neither safe or effective in adolescents |
| 2015-09-17 | Daily Mail | Global drug giant GSK 'published a flawed study which led to millions of children being wrongly prescribed dangerous antidepressants' A global drugs giant published a flawed study which led to millions of children being prescribed potentially dangerous pills, new research reveals. GlaxoSmithKline misled doctors and the public into thinking their antidepressants were safe and effective, even though there was no evidence to back this up. |
| 2015-09-17 | Drug Discovery & Development | Antidepressant Paxil Is Unsafe, Ineffective for Teens, Reanalysis Finds The widely prescribed antidepressant paroxetine — branded as Paxil, Aropax and Seroxat — isn’t a safe or effective treatment for depression in teens, finds a reanalysis of a 2001 study published Wednesday in The BMJ. |
| 2015-09-17 | 6minutes | Paroxetine warning for adolescents There are renewed concerns over the safety of an antidepressant for adolescents following the reanalysis of decade-old trial data by Australian researchers. |
| 2015-09-17 | Australian Doctor | Antidepressant's true suicide risk hidden for years There are renewed concerns over the safety of an antidepressant for adolescents following the reanalysis of decade-old trial data by Australian researchers. The study of... |
| 2015-09-17 | 1 Boring Old Man | study 329 vii – variable variables?… It is essential in Clinical Trials to declare the specific outcome variables and the statistical analytic methodology in the a priori protocol [before the study begins]. That’s the only way to assure that the methodology hasn’t been adjusted, jury-rigged to make the data look a certain way. The standard is to not even allow for the possibility of mistrust. And any changes to the a priori protocol need to be added in as an amendment or modification, approved by the certifying agency ie the Institutional Review Board [IRB]. |
| 2015-09-17 | Washington Post | New analysis shows suicide link for teens on Paxil. ‘Mischief’ in old study claiming drug is safe. A reanalysis of data from a controversial study published in 2001 that opened the doors for doctors to write millions of prescriptions of an antidepressant to children and teens shows that the drug is not only ineffective but potentially unsafe. The new study, published Wednesday in The BMJ, details a number of issues with the original analysis that made paroxetine, marketed as Paxil by GlaxoSmithKline, look more favorable. |
| 2015-09-17 | Cosmopolitan | Experts are calling B.S. on research that made this drug (and others) so mainstream. Chances are you know someone who takes some sort of medication to treat depression. But a new analysis of a 14-year-old study that tested the effectiveness of Paxil, a popular antidepressant, suggests taking it (or similar drugs) may be no more useful than taking placebos, and may actually cause serious, sometimes irreversible side effects like self-harm and suicidal tendencies. |
| 2015-09-17 | Psychiatric News | Reanalysis of JAACAP Study on Paroxetine Sparks Controversy A reanalysis of data from a 2001 study that concluded paroxetine to be generally well tolerated and effective for treating major depression in adolescents has raised questions over the safety and effectiveness of the drug in this patient population, according to a paper published Wednesday in the BMJ. |
| 2015-09-17 | The Australian | Antidepressant paroxetine tips young people into suicide: study An Australian-led study of a popular antidepressant has shown that it can tip young people into suicide. |
| 2015-09-17 | Nursing Times | New analysis of drug trial confirms anti-depressant suicide risk A widely-used anti-depressant is “ineffective and unsafe” when it comes to treating children and adolescents, with an increased risk of suicidal behavior in some, according to a fresh analysis of the findings from a controversial drug trial. |
| 2015-09-17 | Australian Financial Review | Australian doctors lead push for better drug trials by big pharma Fresh analysis by Australian doctors of data from a questionable drug trial is expected to be the first step towards a seismic shift in the way the international pharmaceutical industry assesses drugs |
| 2015-09-17 | The Sydney Morning Herald | British Medical Journal study into paroxetine, Aropax, reveals suicide risk Thousands of prescriptions of a dangerous depression drug that may cause suicidal feelings were given to Australian children last year despite the well-publicised risks, health authorities have revealed. |
| 2015-09-17 | Reuters | Analysis of GSK's Seroxat antidepressant finds key data was held back A medical journal criticised British drugmaker GlaxoSmithKline on Thursday for delaying access to key data from a trial of its antidepressant Seroxat that would have shown earlier that it is neither safe or effective in adolescents. |
| 2015-09-17 | World News | Medical journal attacks GlaxoSmithKline for withholding key information about a popular antidepressant A medical journal criticized British drugmaker GlaxoSmithKline on Thursday for delaying access to key data from a trial of its antidepressant Seroxat that would have shown earlier that it is neither safe or effective in adolescents. |
| 2015-09-17 | Australian Associated Press | Antidepressant suicide link 'undisclosed' An antidepressant was misrepresented as safe for adolescents, says new Australian-led research which has ramifications for drug companies and the reporting of trials. |
| 2015-09-17 | The Chronicle of Higher Education | Landmark Analysis of an Infamous Medical Study Points Out the Challenges of Research Oversight One teenage patient taking the new antidepressant drug Paxil sliced about a dozen six-inch-long cuts into his arm over a period of several days. Another was hospitalized after threatening to kill herself. Neither test subject participating in the clinical trial of Paxil two decades ago was classified by a team of university researchers as suicidal. The researchers, led by Martin B. Keller of Brown University, in a medical-journal article summarizing their findings, instead endorsed Paxil as "generally well tolerated and effective for major depression in adolescents." |
| 2015-09-17 | Medical News Today | Trial review confirms common antidepressant is 'unsafe and ineffective' for teens Widely prescribed to American teenagers since 2001, the antidepressant drug paroxetine is not safe or effective and is no better than placebo, according to a groundbreaking reanalysis of the original trial data. |
| 2015-09-17 | NHS Choices | Antidepressant paroxetine study 'under-reported data on harms' "Seroxat [paroxetine] study under-reported harmful effects on young people, say scientists," The Guardian reports. Researchers have reanalysed data about the antidepressant paroxetine – no longer prescribed to young people – and claim important details were not made public. |
| 2015-09-17 | Nursing Times | New analysis of drug trial confirms anti-depressant suicide risk A widely-used anti-depressant is “ineffective and unsafe” when it comes to treating children and adolescents, with an increased risk of suicidal behavior in some, according to a fresh analysis of the findings from a controversial drug trial. |
| 2015-09-16 | Doctors Lounge | Paxil Isn’t Safe for Teens, New Analysis Says A controversial clinical trial of the antidepressant Paxil came to the wrong conclusion when it declared the drug safe and effective for treating troubled teenagers, according to a reanalysis of the original data more than a decade later. |
| 2015-09-16 | New York Times | Antidepressant Paxil Is Unsafe for Teenagers, New Analysis Says Fourteen years ago, a leading drug maker published a study showing that the antidepressant Paxil was safe and effective for teenagers. On Wednesday, a major medical journal posted a new analysis of the same data concluding that the opposite is true. |
| 2015-09-16 | Retraction Watch | Re-analysis of controversial Paxil study shows drug “ineffective and unsafe” for teens The antidepressant Paxil isn’t safe or effective for teens after all, says a re-analysis of a 2001 study published today in The BMJ. |
| 2015-09-16 | MedPage Today | New Analysis of Paxil Data: Were Adverse Events Downplayed? Fresh look at infamous Study 329 raises questions about pharma transparency |
| 2015-09-16 | The Guardian | Seroxat study under-reported Experts who re-analysed data say study is still referred to in medical literature and needs to be retracted harmful effects on young people, say scientists |
| 2015-09-16 | The Conversation | Antidepressant trial’s upended results show need for sharing all data In 2001, a “landmark” study published in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry purported to show the safety and effectiveness of using a common antidepressant to treat adolescents. But soon after its publication, both researchers and journalists raised questions about the research. |
| 2015-09-16 | CBC News | Reanalysis finds popular antidepressant ineffective, unsafe for teens Independent researchers have recrunched a drug company's data for the antidepressant Paxil and reached the opposite conclusion about its safety and effectiveness in children and adolescents. |
| 2015-09-16 | Medical Brief | Re-analysis finds popular drug ineffective and unsafe The widely used antidepressant paroxetine is neither safe nor effective for adolescents with depression, concludes a re-analysis of an influential study originally published in 2001. The new results, contradict the original research findings that portrayed paroxetine as an effective and safe treatment for children and adolescents with major depression. |
| 2015-09-16 | Mad In America | Psychiatry’s Thalidomide Moment The authors of Study 329 began recruiting adolescents for a comparative study of Paxil, imipramine and placebo in 1994 and finished their investigations in 1997. They dropped a large number of their original cohort, so the randomness element in the study must be open to question. |
| 2015-09-16 | HealthDay News | Paxil Isn't Safe for Teens, New Analysis Says A controversial clinical trial of the antidepressant Paxil came to the wrong conclusion when it declared the drug safe and effective for treating troubled teenagers, according to a reanalysis of the original data more than a decade later. |
| 2015-09-16 | Time | Paxil Is Not Safe or Effective For Teens, Finds New Analysis of Major Study A look at raw data from a controversial trial shows that a drugmaker misrepresented data to show that its medication could treat depression in teens |
| 2015-09-16 | BuzzFeed News | Yet More Evidence That The Antidepressant Paxil Isn’t Safe For Kids A motley crew of retired psychiatrists found tons of problems with a study that hid the risk of kids killing themselves on the antidepressant Paxil. |
| 2015-09-16 | The Washington Post | Researchers: 2001 Paxil study seems to play down suicide risks to youths The study that paved the way for prescribing the antidepressant Paxil to millions of adolescents was seriously flawed, marked by what appear to be attempts to play down harms such as an increase in suicidal behavior by younger people who tested the drug, according to a reanalysis released Wednesday. |
| 2015-09-16 | The Independent | Anti-depressant was given to millions of young people 'after trials showed it was dangerous' Damning study bolsters campaign to open up clinical trial data to public view |
| 2015-09-16 | New Scientist | New look at antidepressant suicide risks from infamous trial YOU may never have heard of it, but Study 329 changed medicine. It was the first trial to highlight serious problems with a common class of antidepressants, but only now have the full results been opened up to independent scrutiny. They show that one drug is even more likely to trigger suicidal behaviour than we thought. |
| 2015-09-16 | New Scientist | Only full disclosure of drug trial results will maintain trust Pharmaceutical firms have a history of suppressing unfavourable results from drug trials. It’s time to compel them to publish data in full |
| 2015-09-16 | Psychology Today | The Truth About Study 329 A major new study about a blockbuster antidepressant |
| 2015-09-16 | EurekAlert | Reanalysis of antidepressant trial finds popular drug ineffective & unsafe for adolescents Results contradict original findings and have important implications for research and practice |
| 2015-09-16 | Press Release | BMJ Publishes Study Revealing How Flawed Drug Research Fails a Trusting Public Band of Intrepid Researchers "Sets the Record Straight" on Ghostwritten Study — Today the BMJ published Restoring Study 329, a decade-long effort by researchers to uncover the truth about the safety of an antidepressant approved for use by adolescents. |
| 2015-09-16 | Medical Daily | Paroxetine, Used To Treat Depression, Was Misrepresented As Safe For Teen Use Researchers have found that an antidepressant prescribed to adolescents and marketed as safe is not only ineffective, but comes with many adverse side effects. |
| 2015-09-12 | 1 Boring Old Man | study 329 v – into the courtroom… When you read an article in a medical journal, all you have to go on is what you’re told in the article itself. If you watched Dr. Healy’s commentary [background music…], you know that this 11 page article represents 77,000 pages of data locked away in some data archive out of sight, a compression ratio of 7,000:1! And if you question an article, there’s no real way to answer your questions without that data. In this case, because of a legal challenge in 2004, the Clinical Study Report has been available on the Internet for a long time. It’s a 528 page document used to submit the paper to regulatory agencies. Over the years, many have read it over and over and found further things to fuel our contention that the original article reached an indefensible conclusion. But all that really did was further refine suspicions. It didn’t prove a thing: |
| 2015-09-11 | 1 Boring Old Man | study 320 iv - some challenges... The RIAT Initiative was a bright idea. Rather than simply decrying unpublished or questionable Clinical Trials, it offers the original authors/sponsors the opportunity to set things right. If they decline, the RIAT Team will attempt to do it for them with a republication. Success depends on having access to the raw trial data and on having it accepted by a peer reviewed journal [see “a bold remedy”…]. Both the BMJ and PLoS had responded to the RIAT article by saying they would consider RIAT articles. |
| 2015-09-10 | 1 Boring Old Man | study 329 iii – the path to the data Not long after Jon Jureidini and Anne Tonkin of Healthy Skepticism questioned these results in a 2003 letter to the editor, Elliot Spitzer, then Attorney General of New York State filed a complaint in 2004 alleging fraud. GSK settled for $2.5M with an agreement to post the data from their pediatric studies of Paxil® on a public Internet Clinical Trials Registry, but admitted no wrongdoing. This would be a good place to review the various packages referred to under the heading data: |
| 2015-09-09 | 1 Boring Old Man | study 329 ii – the importance of protocol I sure don’t want to become 1 terminally boring old man. On the other hand, this is my only available format for communicating. I want to write about the process of evaluating Trials anyway, but I also have a practical reason. A lot of us have clamored for access to the raw data from Clinical Trials, realizing that a lot of the published journal articles are riddled with subtle distortions in both the efficacy and harms analyses, particularly in psychiatry. We intuitively know that if the raw data had been available to us all along, things would be a lot different, and a lot better. But be careful what you ask for, because once you get it, it’s a long and winding road to know quite what to do with it. |
| 2015-09-08 | Dr. David Healy | The Troubled Life of Study 329: Consequences of Failure to Retract If someone were to ask the surviving authors of Study 329 the question: “Knowing what you know now, if you had to do it over, would you agree to participate in that study again?”, many would probably say no. The real title of Study 329 was “Efficacy of Paroxetine in the Treatment of Adolescent Major Depression, A Randomized Controlled Trial”. It was published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in July, 2001. Although it is probably fairly typical of medical research studies, it has been plagued by more than its share of troubles. Next week, fourteen years and two months after it was published, it is about to take yet another hit, when the Restored version is published. |
| 2015-09-08 | 1 Boring Old Man | study 329 i – setting things right "Will this drug help me?" "… hurt me?" "… do nothing?" "What if I don’t take it?" Questions asked as if there’s an answer. But in every case the answer is in the form of likelihoods, not certainties. Each question has "how much?" tacked on – "how much might it help me?" "… hurt me?" Sometimes the answer depends on who you are – male/female? black/white? young/old? One can go on and on with things that might affect the answer, and still only end up with a risk benefit estimate, not the simple answer you want to hear. With interventions that have been around for a while, the doctor and sometimes even the patients have the benefit of long usage that makes things a lot easier. But every new treatment has a beginning with no clinical experience to fall back on. What then? So to the Clinical Trials. |
| 2015-09-05 | 1 Boring Old Man | the growing cry The video in the last post [background music…] is of a talk Dr. Healy gave exactly a year ago when we first submitted our RIAT article about Paxil Study 329 to the British Medical Journal [BMJ]. If you watched it, you know that it’s a historical review of the Clinical Trial and the article that appeared in the Journal of the American Academy of Child and Adolescent Psychiatry [JAACAP] in 2001. |
| 2015-09-03 | Dr. David Healy | Original Study 329 Team Profiles of all the people involved in the original study — from authors to the ghostwriter to the journal editor. |
| 2015-09-03 | Dr. David Healy | Study329.org: Science with a Conscience Faced in 2012 with questions about the $3 Billion fine imposed on GSK – triggered by a sequence of events starting with Study 329, – is it just the cost of doing business? Andrew Witty snapped back: |
| 2015-08-31 | Dr. David Healy | Study 329: The Timelines In addition to hosting the Panorama programs and The Famous Grouse history of Study 329, Study329.org has a comprehensive timeline on the origins of concerns about the SSRIs and the risk of suicide – initially with Prozac and subsequently with Paxil – Seroxat. The chronology is laid out year on year with key documents linked to many of these years. Click on the year, then click on any links – there is days worth of reading for anyone not familiar with the story. |
| 2015-08-27 | Dr. David Healy | Study 329.org: The Panorama Files Study 329 is probably the most famous clinical trial ever. It is one of the few to attract a Fraud action and is certainly the only one with a $3 Billion fine linked to it. The study began recruiting adolescents to Paxil, imipramine or placebo in 1994 and finished up in 1998. Later in 1998, SmithKline Beecham, the marketers of Paxil (they hadn’t discovered it), acknowledged in an internal document that the study had shown that Paxil didn’t work for children. This lack of benefit was something they were not inclined to share with the outside world. Instead they decided then they would pick the good bits out of the study and publish these. |
| 2015-08-17 | Dr. David Healy | A Milestone in the Battle for Truth in Drug Safety Arguably the most controversial drug study ever, Study 329, published in July 2001: 1) Concluded that paroxetine was a safe and effective medication for treating major depression in adolescents; 2) Is still widely cited in the medical literature, providing physicians with assurance about the usefulness of paroxetine... |