Oral hormone pregnancy tests and the risks of congenital malformations

A systematic review and meta-analysis, October 2018.
Includes Primodos drug victims testimonials.

Overview

  • Sources :
    • read and/or download the full study (free access) Oral hormone pregnancy tests and the risks of congenital malformations: a systematic review and meta-analysis, F1000Research, First published 31 Oct 2018, 7:1725, DOI:10.12688/f1000research.16758.1.
    • read and/or download the full study (free access) The Primodos components Norethisterone acetate and Ethinyl estradiol induce developmental abnormalities in zebrafsh embryos, nature, Published 13 Feb 2018, DOI:10.1038/s41598-018-21318-9.
  • Testimonials : read some real stories told by the Primodos victims, see the post comment section.
  • Commenting : scroll down this page until you reach the header “Have your say! Share your views” and the box “Enter your comment here…“.

Abstract

Background
Oral hormone pregnancy tests (HPTs), such as Primodos, containing ethinylestradiol and high doses of norethisterone, were given to over a million women from 1958 to 1978, when Primodos was withdrawn from the market because of concerns about possible teratogenicity. We aimed to study the association between maternal exposure to oral HPTs and congenital malformations.

Methods

I am fully supportive of this article on the effects of hormone pregnancy tests as it stands. I have no substantive criticism of the content or methods.

Dr David Healy, professor of psychiatry, psychopharmacologist, scientist and author.

We have performed a systematic review and meta-analysis of case-control and cohort studies that included data from pregnant women and were exposed to oral HPTs within the estimated first three months of pregnancy, if compared with a relevant control group. We used random-effects meta-analysis and assessed the quality of each study using the Newcastle–Ottawa Scale for non-randomized studies.

Results
We found 16 case control studies and 10 prospective cohort studies, together including 71 330 women, of whom 4209 were exposed to HPTs.

Exposure to oral HPTs was associated with a 40% increased risk of all congenital malformations: pooled odds ratio (OR) = 1.40 (95% CI 1.18 to 1.66; P<0.0001; I2 = 0%).

Exposure to HPTs was associated with an increased risk of

  • congenital heart malformations: pooled OR = 1.89 (95% CI 1.32 to 2.72; P = 0.0006; I2=0%);
  • nervous system malformations OR = 2.98 (95% CI 1.32 to 6.76; P = 0.0109 I2 = 78%);
  • gastrointestinal malformations, OR = 4.50 (95% CI 0.63 to 32.20; P = 0.13; I2 = 54%);
  • musculoskeletal malformations, OR = 2.24 (95% CI 1.23 to 4.08; P= 0.009; I2 = 0%);
  • the VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects), OR = 7.47 (95% CI 2.92 to 19.07; P < 0.0001; I2 = 0%).

Conclusions
This systematic review and meta-analysis shows that use of oral HPTs in pregnancy is associated with increased risks of congenital malformations.

Reactions

Prof. Henegan’s systematic analyses of epidemiological studies, is a scientific review which members of the Association for children damaged by HPT’s have waited over 45 years for. The findings are incredible and mirror the congenital abnormalities suffered by our members. It is a scandal that this epidemiological study was not commissioned by the Government Health Authorities and we cannot thank Prof. Heneghan and his colleagues enough, for the comprehensive and utterly compelling review.

Marie Lyon,
Assocation for Children Damaged by Hormone Pregnancy Tests, UK

Important Note

Are you a Primodos-victim ?
Send a request to join the group Primodos (The Forgotten Thalidomide) ACDHPT on Facebook.

Reanalysis of Study 329: efficacy and harms of paroxetine and imipramine in adolescents

How difficult it is to get the truth about questionable drugs

The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.

Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative.

Jon Jueridini and colleagues have reanalysed SmithKline Beecham’ infamous Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression.

The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomised controlled trial would have clinically relevant implications for evidence based medicine.

Their analysis finds that neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs.

More on Study 329 from The BMJ
  • Study 329, doi.org/10.1136/bmj.h4973, 17 September 2015.
  • Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence, doi.org/10.1136/bmj.h4320, 16 September 2015.
  • No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility, doi.org/10.1136/bmj.h4629, 16 September 2015.
  • Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence, doi.org/10.1136/bmj.h4320, 16 September 2015.
  • Restoring invisible and abandoned trials: a call for people to publish the findings, doi.org/10.1136/bmj.f2865, June 28, 2013.
More on Study 329 from Dr David Healy’s blog
More on Study 329
  • Initial – 1st – Study 329, jaacap, July 2001.
  • Restoring Study 329, website.
  • About : Documenting Seroxat : An Epic Medical Scandal, truthman30/.

Study 329 Lessons: published conclusions about drugs efficacy and safety should not be read as authoritative

Study 329 reanalysis illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base

study-329 poster
Unpublished and misreported studies make it difficult to determine the true value of a treatment. RIAT stands for “restoring invisible and abandoned trials.

2015 (2nd) Study Abstract

The RIAT re-analysis marks a new chapter in the story of Study 329, showing the remarkable power of open data. But it also shows how much our current systems are failing patients and the public. It should not have taken 14 years to get to this point. It shows that we need regulation, and perhaps legislation, to ensure that the results of all clinical trials are made publicly available and that individual patient data are available for legitimate independent third party scrutiny.

Objectives
To reanalyse SmithKline Beecham’s Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomised controlled trial would have clinically relevant implications for evidence based medicine.

Design
Double blind randomised placebo controlled trial.

Setting
12 North American academic psychiatry centres, from 20 April 1994 to 15 February 1998.

Participants
275 adolescents with major depression of at least eight weeks in duration. Exclusion criteria included a range of comorbid psychiatric and medical disorders and suicidality.

Interventions
Participants were randomised to eight weeks double blind treatment with paroxetine (20-40 mg), imipramine (200-300 mg), or placebo.

Main outcome measures
The prespecified primary efficacy variables were change from baseline to the end of the eight week acute treatment phase in total Hamilton depression scale (HAM-D) score and the proportion of responders (HAM-D score ≤8 or ≥50% reduction in baseline HAM-D) at acute endpoint. Prespecified secondary outcomes were changes from baseline to endpoint in depression items in K-SADS-L, clinical global impression, autonomous functioning checklist, self-perception profile, and sickness impact scale; predictors of response; and number of patients who relapse during the maintenance phase. Adverse experiences were to be compared primarily by using descriptive statistics. No coding dictionary was prespecified.

Results
The efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any prespecified primary or secondary efficacy outcome. HAM-D scores decreased by 10.7 (least squares mean) (95% confidence interval 9.1 to 12.3), 9.0 (7.4 to 10.5), and 9.1 (7.5 to 10.7) points, respectively, for the paroxetine, imipramine and placebo groups (P=0.20). There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.

Conclusions
Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.

More on Study 329 from The BMJ
  • Study 329, doi.org/10.1136/bmj.h4973, 17 September 2015.
  • Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence, doi.org/10.1136/bmj.h4320, 16 September 2015.
  • No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility, doi.org/10.1136/bmj.h4629, 16 September 2015.
  • Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence, doi.org/10.1136/bmj.h4320, 16 September 2015.
  • Restoring invisible and abandoned trials: a call for people to publish the findings, doi.org/10.1136/bmj.f2865, June 28, 2013.
More on Study 329 from Dr David Healy’s blog
More on Study 329
  • Initial – 1st – Study 329, jaacap, July 2001.
  • Restoring Study 329, website.
  • About : Documenting Seroxat : An Epic Medical Scandal, truthman30/.

Morts sur ordonnance

Des substances aux effets secondaires sévères…

Documentaire, “Morts sur ordonnance” durée 52’, auteur-réalisateur Olivier Pighetti. Production Piments Pourpres Productions, avec la participation de France Télévisions, 2014.

Plus d’information
  • Anxiolytiques, antidépresseurs, somnifères et autres tranquillisants sauvent des vies, mais de nombreux experts parlent aussi de «bombes à retardement» : ils seraient à l’origine de vagues de suicides, de troubles de comportement graves, d’homicides et certains seraient plus addictifs que les drogues dures. Aux Etats-Unis, les procès intentés par les victimes ont coûté des milliards de dollars aux industries pharmaceutiques. Pourtant, ces médicaments restent un best-seller planétaire et, en tant que premier consommateur mondial, la France représente un véritable tiroir-caisse. Ce film montre la dangerosité potentielle de ces molécules et analyse comment l’industrie pharmaceutique a verrouillé le marché, avec un cynisme effrayant.
  • Regardez cette liste de vidéos sur l’industrie pharmaceutique sur notre chaîne YouTube.

Maker of world’s best-selling drug uses legal action to keep data secret

Paper via theconversation, 8 November 2013, written by Dr David Healy, professor of psychiatry and co-founder of data based medicine, operating through RxISK, working towards making medicines safer

Paper via theconversation, 8 November 2013, written by Dr David Healy, professor of psychiatry and co-founder of data based medicine, operating through RxISK, working towards making medicines safer.

clinical-data-files image
Opening the safe on safety data

In 2010, the European Ombudsman ruled that the European Medicines Agency should open access to clinical trials data when companies applied to get their drugs on the market. The ombudsman decided public health was more important than considerations of commercial confidentiality.

In February 2013, the US pharmaceutical company AbbVie, who make Humira – the best-selling drug in the world today – and another company Intermune independently took legal action against the EMA’s open access policy after they were tipped that competitors had requested access to clinical study reports and the EMA was going to grant it. In one of the most important healthcare legal actions ever taken, the court upheld the pharmaceutical companies’ positions.

Six months later, the European Federation of Pharmaceutical Industries and Associates (EFPIA), convened a meeting in Brussels to look at the issue of trial data access. Neal Parker, a senior legal figure within AbbVie, said it was in “the public health interest to maintain commercial confidentiality to drive business forward.

While “a vast amount of data was released without controversy”, he said, a competitive landscape meant that the remaining data had to be in the control of companies.

Adverse effects and Eastern threats?

However, Parker caused a stir by intimating that data on adverse drug reactions should be treated as commercially confidential – an unusual admission. To protect these and other data such as demographic information and lab results, the company were seeking corporate privacy rights.

But there was another little remarked intervention close to the middle of the meeting, when Richard Bergström, the EFPIA’s Director General, intervened to say that most of the organisation’s industry members were “quite relaxed” about data disclosure. For most products, apart from products in highly competitive fields such as biologics (products created using biological processes rather than synthesising chemicals and which include vaccines), there would be no issues. But Bergström added:

“You might get companies from South Korea or China breathing down your neck trying to copy your technology, then you get extra sensitive.”

This comment raises a question. While the commentariat have been debating access to clinical trial data in the media, is the action actually elsewhere and about something entirely different?

EMA licenses new rival

In September, a little over two weeks after this meeting, the EMA provisionally approved infliximab biosimilar (trade name Inflectra), an antibody drug for use in the same inflammatory diseases AbbVie’s Humira is used for: rheumatoid arthritis, Crohn’s disease and psoriasis.

Infliximab is the core compound in Remicade, another drug used to treat Crohn’s disease and rheumatoid arthritis and developed by Johnson & Johnson. Remicade was one of the first biologics or MABs (monoclonal antibodies) type of drugs, of which Humira has become the most famous.

The branded pharmaceutical industry has always fought hard against generic drugs which eat into their blockbuster profits and they have fought tooth and nail to stop “generic” versions of any of these biologics being launched based on the argument that no generic can be identical to its parent biologic.

There are in fact irreducible differences between all of the original MABs and derivative biologics. And this has given rise to the concept of the biosimilar, to which the new Inflectra belongs and which can be produced more cheaply. And the pipeline for new drugs is so poor that blocking biosimilars has become almost a life or death issue for the branded companies.

Cats in bags and spiralling costs

So where do Richard Bergström’s comments fit into all of this and did he let the cat out of the bag by mentioning Korea?

The newly approved Inflectra was made by Celltrion – a Korean company – working in collaboration with Hospira, a new kind of pharmaceutical company that has emerged to help develop biosimilars. Hospira, based in both the US and UK, is the first company to major on the market development of biosimilars. It filed the application to market Inflectra in America and Europe (and as Celltrion’s Remsima in other markets).

This could lead to the price of biologics, which can cost anywhere between $20,000 and $500,000 (£12,000 – £300,000) per year, falling dramatically: Inflectra will likely cost 33% less than Johnson & Johnson’s Remicade and will have knock on effects for Humira.

Margaret Chan, Director General of the World Health Organisation, said earlier this year:

The costs of many new medical products are becoming unsustainable for even the wealthiest countries in the world. [Of the 12 cancer drugs approved last year], 11 were priced above the $100,000 per patient per year. This price is unaffordable, for most patients, most health budgets and most insurance companies. These are problems for all countries, not just the developing world.

Before the MABs, big insurance companies like UnitedHealth Group, Humana and others simply paid out on new drugs. They offered a reimbursement rather than an insurance service. But now that biologics are so much more expensive than older drugs, companies in this area, especially larger companies, have had to become insurers rather than just reimbursers. And the development of biosimilars offers these insurance companies huge leverage. Companies like Hospira and Celltrion have a chance to change healthcare radically, but it involves competition – and perhaps a commercial threat from the East.

AbbVie was until recently Abbott Laboratories, one of the world’s biggest pharmaceutical companies, and wields significant power. Big pharma argue that protecting commercial interests protects their investment – and without it we wouldn’t have new drugs.

But while campaigners fight for more transparency over clinical trial data, and by extension information about adverse effects and risk that some medicines may pose, there is a two-fold problem which all this reveals: how commercial interests mean more expensive drugs and treatment potentially denied to those who desperately need it, despite us knowing that there may be a way to help.

The timing of AbbVie’s action against the EMA policy suggests that this was not really about transparency at all but about trying to deter the EMA from licensing Inflectra/Remsima, and a raft of cheaper, more available drugs. It was filed at a time when the threat it posed might still have played a part in the considerations of EMA or the politicians to whom EMA has to answer.

The European Court is due to deliver an initial judgement in the next few weeks on the decision to allow the trial data to be withheld. Transparency (and access to safety data) will be dealt a severe blow if AbbVie and Intermune triumph. And we may well also be worse off without cheaper competitive biosimilars on the market.

Pharma Industry fear a Boycott more than anything else

” I don’t think industry are concerned about patient confidentiality except in so far as they are concerned to avoid being sued for injuries in clinical trials. ”

There is a very informative and fascinating debate going on between Dr David Healy and Ben Goldacre regarding options, thoughts, strategies for better clinical trials access and transparency.
Dr. David Healy posted “fuckedhere and I posted a summary here.
Dr Ben Goldacre responded here and here. I republished his reply here.
Dr. David Healy then clarified here – see below – I only added few related links (in the original text response) with the purpose to bring more clarity and/or references to the readers.

Again let me invite you to read “fucked” post 22 comments – about clinical trial data access and pharmaceutical industry transparency.

image of David Healy
David Healy is professor of psychiatry and co-founder of data based medicine, operating through RxISK.org , working towards making medicines safer.

The first point to make is this post isn’t about AllTrials.
AllTrials is a footnote.

It’s about the dismay that many felt at EMA backsliding. It’s about how it was obvious that something like this was on the cards. Against this background uncritical endorsement of industry looked like a bad idea. There was a desperate need to stay awake. It looks like too many of us have been asleep.
Ben offers an outline of the AllTrials strategy here. It’s helpful to have this.
His accusation that these posts misrepresent campaigns, smear people, shout abuse, and hector from the sidelines looks like a description of posts by others elsewhere. With very few exceptions any comments to the various posts on this blog that in any way fail to support Ben or AllTrials have been deleted.
The post repeated an alternate analysis – that the main thing industry wants to hide are adverse event data.
In a post 18 months ago I outlined how to achieve this industry would in public deploy the issue of patient confidentiality as a main justification for hiding data. In this it seems to me they have been assisted by Iain Chalmers editorial with Patrick Vaillance and now by Ben.
The historical evolution of the confidentiality issue is that the first informed consent forms said nothing about not showing your data to anyone else. Unnoticed industry have slipped in a “we will of course show your data to no-one clause”.
At the EMA conference on data access in November 2012, I made two points. The second was that industry would assert the notion of their privacy rights – which they have done. The other was that no one signs to have their data sequestered. Afterwards, Iain Chalmers congratulated me on the point – I thought we were on the same page.
Whether adverse event data is key or not, Peter Gotzsche through the European Ombudsman and Tom Jefferson and Peter Doshi through Tamiflu and RIAT seem to me to have done more in practical terms to move the issues forward than anyone else. It leaves me wondering why there is an endless call to celebrate Ben and not Peter or Tom.
Some of us have been working the GSK system and can see what the pitfalls are. Even if not redacted, this is a system that will make it close to impossible to analyse CSRs properly. But if it’s not proclaimed by AllTrials first it seems like such insights are unwelcome.
In several posts before the latest debacle I outlined how in my opinion there was a real chance that magnificent though he has been and clearly morally right, Peter Gotzsche’s efforts may do more harm than good. Even without taking GSK’s preposterous data access system into account, pushing for data adds to the undue premium being put on RCTs Twenty years ago the moral case for access was as strong and the risks consequent on failing were much less in that we were less hypnotized by RCTs than we are now.
Far from responding shrilly, Peter Gotzsche recognized the risk and we have been collaborating ever more closely since. The issues are so complex we might all be making mistakes – the only people unwilling to concede this seem to be AllTrials.
The push for data access remains morally compelling but there are other things that can be done that might be more effective.
As the BBC program a week ago on Thalidomide, and previous posts here, make clear, industry fear a boycott more than anything else. It is the only thing they have ever responded to.
At the moment the focus is on a bunch of bureaucrats in EMA, who aren’t there with a brief to protect us other than by regulating the wording of advertisements.
The focus should be on doctors who treat patients. We could refuse to use drugs where there is no access to the data. It shouldn’t even take courage to do this. In my opinion, this is the call that’s needed now rather than a call to support more of what AllTrials have been doing. But who will lead such a call?
Along with colleagues I put forward a softer version of a boycott – an AbbVie – which encouraged doctors and patients to use drugs but to report on the adverse events which would in fact make these chemicals better medicines. It would be difficult for government or anyone else to gainsay this win-win option in the way they might come out against the lose-lose of a boycott.
There is a conflict of interest here. RxISK.org has a stake in this idea. It was set up before AllTrials to move ideas like this forward. I suspect those of us working on RxISK in the evenings and at weekends have been putting far more hours into the effort than the AllTrials team have.
At the end of the day, I may well be wrong on this, but I personally think AllTrials have been naïve. I don’t think industry are concerned about patient confidentiality except in so far as they are concerned to avoid being sued for injuries in clinical trials.
Recent decades have seen industry put Litigation Support Defences in place. As outlined a decade ago in Let Them Eat Prozac, putting a premium on clinical trials has been a key element in their litigation support strategy. Seen from this vantage point AllTrials offers Pharma a lot – all without the effort of having to conspire or fund a conspiracy.
Playing straight into industry’s hands is a hazard for all of us. Good intentions aren’t enough to save us. I’d rest more comfortably if the key players in AllTrials had a track record in bringing adverse events to light or even a record of supporting those trying to do so – if they’d really antagonized industry good and proper. It’s not that partnership isn’t nice but perhaps after playing hard to get first. ”

Find all our posts about the AllTrials campaign, Clinical trials, Dr Ben GoldacreDr. David HealyGlaxoSmithKlinePeter Gøtzsche and Sir Iain Chalmers.

David Healy misrepresents All Trials and Ben Goldacre

This blog post by David Healy is absurd – Dr Ben Goldacre response to Dr David Healy

After I posted “Fu*£ed or WTF is going on? @DrDavidHealy Thoughts about #AllTrials @BenGoldacre #GSK @Truthman30” yesterday, Dr Ben Goldacre visited DES Daughter Network’s blog leaving a comment which has now appeared on Dr David Healy’s website. I only added few related links (in the original text response) with the purpose to bring more clarity and/or references to the readers.

image of ben goldacre
Ben Goldacre is doctor, nerd cheerleader, Bad Science person, stats geek, procrastinator.

” Hi there,

I’ve posted this on David Healy’s blog, it’s currently “In Moderation” so I’m posting it here too in case it’s of interest.

This blog post by David Healy is absurd.

The AllTrials campaign is really simple: it calls for all trials to be registered, with their full methods and results made publicly available. Where CSRs have been made, we call for those to be placed in the public domain.

Healy says we’ve created a situation where people are withholding CSRs: that’s simply absurd, this is precisely what we campaign against.

Healy says we’ve created a situation where CSRs are inappropriately redacted: that’s absurd, again, this is specifically what we campaign against.

Healy says we have created a situation where drug companies get to choose who has access to CSRs: again, that is ridiculous, this is exactly what we campaign against.

GSK have signed up to the AllTrials campaign: they join over a hundred patient groups, more than 75,000 members of the public, NICE, Wellcome, MRC, almost all academic and medical professional bodies in the UK, and a growing number around the world. When Bad Pharma came out, industry and others were able to pretend that information about clinical trials is no longer withheld. We’ve transformed that, triggered two select committees and put the policy issue on the map, created a coalition, unpicked a web of dangerous false reassurances by professional bodies, and made it impossible for industry to engage in glib denialism.

I’m delighted that GSK have signed up to AllTrials, along with all the other organisations. There are lots of problems in medicine. There lots of people and organisations who’ve done – and continue to do – things I think are harmful to public health. But where people do the right thing, I will applaud them for it. I genuinely think that’s the right thing to do. It doesn’t mean you’re part of an elaborate and complex conspiracy with people. It doesn’t mean you approve of everything they do at work and at home.

It’s easy, and attractive, to scream from the sidelines, and carry on screaming forever. It’s also possible to shout out clearly and succinctly about problems, try to set out and discuss clear solutions, floodlight the path forwards, and encourage people to go down it.

Lastly, and specifically, the issue of individual personal data. The AllTrials campaign doesn’t call for all the rich individual patient data from all trials to be simply posted publicly in the public domain: that poses too much of a privacy risk, because patients are identifiable in this data. This privacy risk isn’t as big as is claimed by some of those who seek to block transparency, but we decided that the issues around graded access control to IPD are too complex for a simple headline campaign, and we didn’t want to risk industry using the issues around protecting participants’ privacy as an excuse to derail discussion on the very important separate issue of access to methods and summary results. We were absolutely right: industry have repeatedly tried to pretend that AllTrials calls for individual trial participants’ personal data to be posted online, even though AllTrials is specifically focused on registration, methods, results, and CSRs. But as David Healy knows, most of the people involved in the AllTrials campaign, myself, Iain Chalmers and the BMJ included, are closely involved in pushing for greater transparency on IPD too. It is simply absurd to claim otherwise.

The comments section on this blog is clearly the worst place to say this, but it really is a big waste of everyone’s time to have to deal with the kind of misrepresentation and abuse that David Healy keeps posting. From past experience, I don’t believe that David will engage constructively with my taking the time to correct these repeated misrepresentations, and I honestly think that’s a shame. We’re all – most of us at any rate – trying to get things improved. Everyone’s time is short, and people run things like AllTrials in their spare time. If Healy has a better way to make things better, that’s great, he should crack on with it and get others behind him. If it involves misrepresenting campaigns, smearing people, shouting abuse, and hectoring from the sidelines, then I won’t be in.

As an addendum, three brief specifics, since time is short:

David Healy, above: 
“Consent processes in clinical trials were about telling you you were on a new drug that might be dangerous or might be involved in a marketing trial. Instead they have become a way for companies to justify hiding your data on the basis of a confidentiality clause they have slipped into the forms. Iain ChalmersBen Goldacre and AllTrials appear to have signed up to this.”
– This is complete and utter fantasy. Neither I nor AllTrials have signed up to this. David Healy will be unable to provide any evidence to show that we have. Consent forms being used to justify withholding information is exactly what I’ve campaigned against.

David Healy, above:
 “That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been.”
– This is completely bizarre. AllTrials simply calls for all trials to be registered, with their full methods and results made freely publicly available, and CSRs where they’ve been created. It is impossible to argue that this “locks academics into agreeing with GSK and other companies as to what the outcomes of their trials have been”.

David Healy, above:
 “Rape is a loaded word these days”.
It’s always been a loaded word, David. “

Fu*£ed or WTF is going on?

Dr. David Healy: “We told you here 18 months ago not to trust GSK – but BMJ and All Trials went ahead”…

image of David Healy
David Healy is professor of psychiatry and co-founder of data based medicine, operating through RxISK.org , working towards making medicines safer.

Last year, after GlaxoSmithKline (GSK) was fined $3 billions, then signed the All Trials campaign, we were wondering if other pharmaceutical companies would follow GSK plans to share detailed clinical trial data online for researchers. What if “their selective transparency is a smokescreen for a wider, more nefarious agenda, which is further control” warns @Truthman30…

In his recent post, Dr. David Healy explains the following:

Read Fucked – Apologies for the Language
by Dr David Healy, CEO of RxISK, May 21, 2014.

Relabeling the Medications we call AntiDepressants

Do the data on the drugs we call antidepressants justify the label of “antidepressant”?

Relabeling the Medications We Call Antidepressants
Do the data on the drugs we call antidepressants justify the label of “antidepressant”?

Abstract:
This paper raises the question about whether the data on the medications we call antidepressants justify the label of antidepressant. The authors argue that a true antidepressant should be clearly superior to placebo, should offer a risk/benefit balance that exceeds that of alternative treatments, should not increase suicidality, should not increase anxiety and agitation, should not interfere with sexual functioning, and should not increase depression chronicity. Unfortunately, these medications appear to fall short on all of these dimensions. Many of the “side effects” of these medications have larger effect sizes than the antidepressant effect size. To call these medications antidepressants may make sense from a marketing standpoint but may be misleading from a scientific perspective. Consumers deserve a label that more accurately reflects the data on the largest effects and helps them understand the range of effects from these medications. In other words, it may make just as much sense to call these medications antiaphrodisiacs as antidepressants because the negative effects on libido and sexual functioning are so common. It can be argued that a misleading label may interfere with our commitment to informed consent. Therefore, it may be time to stop calling these medications antidepressants.

Sources: NCBI, by Dr David Healy, PMID: 24278764, 4 June 2012

Full Article: Scientifica, by Dr David Healy
Volume 2012 (2012), Article ID 965908, 6 pages, 28 May 2012

Our posts tagged Anti-Depressants – Drugs – SSRIs

AbbVieing or the Opposite of Boycotting

A good medicine is a good chemical plus good information

Lets do the AbbVie again
AbbVieing is the opposite of Boycotting

Dr David Healy says that it’s time for another invention – the #AbbVie. AbbVieing is named after the pharmaceutical company AbbVie (NYSE:ABBV) – the recent spun-off entity of Abbott Laboratories. It is almost the opposite of Boycotting.

Far from shunning and not mentioning AbbVie or their drugs, Dr David Healy call on everyone taking an AbbVie or InterMune drug, listed on his post, to talk loudly about them by reporting to RxISK any side effects they may be having on these medications. Dr David Healy want us to talk about these drugs and to their companies.