Archive for 10 enero 2014

Un informe imprescindible: House of Commons – Access to clinical trial information and the stockpiling of Tamiflu – Public Accounts Committee

enero 10, 2014

Access to clinical trial information and the stockpiling of Tamiflu

vía House of Commons – Access to clinical trial information and the stockpiling of Tamiflu – Public Accounts Committee.

Conclusions and recommendations
On clinical trials
1.  We were surprised and concerned to discover that information is routinely withheld from  doctors  and  researchers  about  the  methods  and  results  of  clinical  trials  on treatments  currently  prescribed  in  the  United  Kingdom.  This  problem  has  been noted for many years in the professional academic literature, with many promises given,  but  without  adequate  action  being  taken  by  government,  industry  or
professional bodies. This now presents a serious problem because the medicines in use  today  came  on  to  the  market—and  were  therefore  researched—over  the
preceding  decades.  None  of  the  latest  proposals  from  regulators  or  industry
adequately addresses the issue of access to the results of trials from previous years on the medicines in use today.
Recommendation:  The  Department  should  take  action  to  ensure  that  the  full methods and results are available to doctors and researchers for all trials on all uses of all treatments currently being prescribed, and should also ensure that there is clear and frequent audit of how much information is available and how much has been withheld.
2.  The  results  of  clinical  trials  on  humans  are  the  key  evidence  used  by  regulators, researchers  and  clinicians  to  assess  whether  a  medicine  works  and  how  safe  it  is.
Medicine manufacturers submit evidence on products they wish to market in the UK
to  the  Medicines  and  Healthcare  Products  Regulatory  Agency  (MHRA)  or  the
European Medicines Agency (EMA).
3.  The scope for independent scrutiny of a medicine’s effectiveness is undermined by the fact that the full methods and results of many clinical trials are not made available to doctors and researchers. The problem of non-publication of clinical trial results has been known since the mid-1980s. We also heard evidence that trials with positive results are about twice as likely to be published as trials with negative results. While several clinical trial registries have been established, none covers all clinical trials on all  uses  of  all  treatments  currently  being  prescribed  worldwide.  There  have  been recent announcements by the EMA, and some manufacturers, to improve access to information  about  clinical  trials  but  none  adequately  addresses  the  issue  of incomplete  disclosure  throughout  medicine.  Opening  up  information  about  all clinical  trials  to  medical  researchers  would  support  the  work  of  regulators  by permitting thorough, independent external review by doctors and researchers .
Recommendation:  The  Department  and  the  MHRA  should  ensure,  both
prospectively  and  retrospectively,  that  clinical  trials  are  registered  on  an
appropriate registry and that the full methods  and  results  of all trials should be
available  for  wider  independent  scrutiny,  beyond  the  work  undertaken  by
regulators during the licensing process.
4.  NICE  and  the  MHRA  do  not  routinely  share  information  provided  by
manufacturers during the process for licensing medicines. When applying for a
licence, manufacturers have a legal obligation to provide all the information on the
safety and efficacy of a medicine that is required by European regulators. However,
NICE does not have statutory powers to demand information from manufacturers,
in  contrast  to  the  Institute  for  Quality  and  Efficiency  in  Healthcare  in  Germany, which performs a similar role to NICE. NICE seeks confirmation from the medicine manufacturer’s UK medical director on the completeness of information, but this may not include all clinical trials in other parts of the world, not least because UK medical directors may themselves not have full information. The MHRA confirmed there  was  no  legal  obstacle  that  would  prevent  it  from  sharing  information  with NICE.  However,  there  is  no  routine  sharing  of  the  information  provided  by manufacturers to regulators as part of the licensing process with NICE. This leads to the risk of omissions and duplication in the collection of evidence.
Recommendation: NICE should ensure that it obtains full methods and results on all trials for all treatments which it reviews, including clinical study reports where necessary;  make  all  this  information  available  to  the  medical  and  academic community for independent scrutiny; and routinely audit the completeness of this information.  NICE  and  the  MHRA  should  put  in  place  a  formal  information-sharing agreement to ensure when NICE appraises medicines it has access to all of the information provided to regulators by the manufacturer during the licensing process.

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It’s a scandal drug trial results are still being withheld | Ben Goldacre|The Guardian

enero 10, 2014

Nobody can give you a fully informed view on the benefits of any treatment, let alone Tamiflu, because the results of clinical trials are being routinely and legally withheld from doctors, researchers and patients. As the committee pointed out, government agencies around the world disagree on whether Tamiflu reduces your chances of pneumonia and death, but we can have no idea who is right, because we can\’t see the evidence.

vía It’s a scandal drug trial results are still being withheld | Ben Goldacre | Comment is free | The Guardian.

5 de enero de 2014…

Japan to File Criminal Complaint Against Novartis

enero 10, 2014
 
 
 

Blood Pressure Drug Ad Prompts Japan to File Criminal Complaint Against Novartis

 

by Thilaka Ravi on  January 08, 2014 at 8:14 AM Drug News

 

Local arm of Swiss pharmaceutical giant Novartis will have to face a criminal complaint leveled against it by Japan’s health ministry over alleged exaggerated advertising for a popular blood-pressure drug, Kyodo News agency reported.

 

Blood Pressure Drug Ad Prompts Japan to File Criminal Complaint Against Novartis

 

 

 

Novartis Pharma KK has been under fire since a university said the data in clinical studies might have been skewed to promote Valsartan.

Health Minister Norihisa Tamura has characterised as “extremely regrettable” the incident in which an employee of the world’s number two drug maker hid his affiliation during a medical study into the effects of the drug used to lower blood pressure.

Under Japan’s pharmaceutical law, anyone found guilty of exaggerated advertising can be punished with up to two years’ prison or a fine of as much as two million yen ($19,400).

It would be the first time a criminal complaint has been filed in Japan over exaggerated pharmaceutical advertising, Kyodo said, quoting ministry officials.

A ministry panel of experts concluded in September that Novartis Pharma KK should be held responsible for studies at various universities that used manipulated data on the drug.

The studies suggested the drug — sold under the name Diovan in Japan and licensed for use in more than 100 countries — had some prophylactic effect on strokes and angina.

The firm used data from the studies to market its drug, playing up its supposed additional benefits.

Novartis has maintained that the company had no knowledge of the wrongdoing, in which an ex-employee allegedly failed to disclose his affiliation with Novartis during various academic studies in which incomplete clinical data were used.

The worker and other researchers involved in studies have denied to the panel that they manipulated the data.

Novartis Pharmaceuticals chief David Epstein has apologised for concern the incident caused, but did not admit the company’s role in the allegations.

Tokyo’s Jikei University School of Medicine has retracted research that appeared in respected medical journal The Lancet six years ago due to data fabrication.

Kyoto Prefectural University of Medicine also concluded that its studies on the drug used incomplete clinical data.

Chiba University said in December it could not find intentional data fabrication but researchers failed to disclose 91 million yen ($880,000) in scholarship donations from the pharmaceutical company in the three years from 2007 to 2009.

Read more: Blood Pressure Drug Ad Prompts Japan to File Criminal Complaint Against Novartis | Medindia http://www.medindia.net/news/blood-pressure-drug-ad-prompts-japan-to-file-criminal-complaint-against-novartis-130174-1.htm#ixzz2pzPIdgQb

 

 

Lancet: Retraction—Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study)

enero 10, 2014

Retraction—Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study

The Lancet published the Jikei Heart Study in April, 2007.1 On July 31, 2013, we were informed by Professor Kazuhiro Hashimoto (Jikei University) that there had been a press conference on July 30 reporting an interim conclusion from an internal investigation into this research. The report considered that “The data on blood pressure are not reliable…”. Given this finding, we now wish to retract the Jikei Heart Study on the grounds that we no longer have confidence in the published results.
When the Jikei Heart Study was first published, Staessen and Richart2 congratulated the investigators on their report. But we soon became aware that there was concern in Japan about the trial. Indeed, there was not only concern about the Jikei Heart Study, but also the Kyoto Heart Study, which was published in the European Heart Journal in 2009.3 Both reports were about valsartan and had several authors in common. In October, 2011, we received correspondence expressing concern about the similarity of the standard deviations of the mean blood pressure measurements in the two studies, and we invited the authors to comment. Although we were initially satisfied with their response, in 2012 we published a letter from Dr Yui reporting further concerns.4
The retraction of the Kyoto Heart Study5 in February, 2013 led to an investigation into the conduct of the Jikei Heart Study. An investigating committee headed by Professor Hashimoto from Jikei University was established. We became aware of this development on April 29, 2013, and on May 2 we wrote to Jikei University asking for details of the investigation and requesting that we be kept informed. We wrote again on June 4 and June 19 asking when the investigation might be completed. We wrote again on July 31 after we were made aware that a press conference had been held. By return we received a synopsis of the investigation’s findings. The report identifies concern over the reliability of the blood pressure data: “We believe, therefore, that the data were intentionally altered.” The report goes on to say: “We suspect that the data were altered during their statistical analysis.”
The report also comments on the affiliation of the person entrusted with the statistical analysis, Nobuo Shirahashi. Mr Shirahashi’s affiliation, as provided to The Lancet, was: “Clinical epidemiology, Osaka City University Graduate School”. In April of this year, The Lancet received a letter from a professor at Osaka City University Graduate School of Medicine informing us that there has never been a Department of Clinical Epidemiology in the university, that Osaka City University “has never had the statistical analysis group for Jikei Heart Study”, and that Mr Shirahashi “has never been staff of our university” but was employed by Novartis Pharma Japan.
Our attempts to obtain a response from Mr Shirahashi were hindered by his recent retirement from Novartis, but the Global Head of Medical Affairs, Dr Usman Azam, did share with The Lancet that Mr Shirahashi had been employed by Novartis throughout the period of the trial and its publication. Dr Azam also told us: “In addition, it appears Mr Shirahashi obtained an unpaid position in about 2001 with the Osaka City University Graduate School’s Medical Research Faculty as a part-time lecturer in the Department of Medicine. He held the position until 2011.” Dr Azam further acknowledges “…that Mr Shirahashi should have requested the studies’ authors to identify him as a Novartis Pharma K.K. employee”.
Taken together, these findings indicate that there is now sufficient doubt as to the integrity of the Jikei Heart Study and the obfuscation over affiliation of the study statistician for The Lancet formally to retract the paper from the scientific record.

References

1 Mochizuki S, Dahlof B, Shimizu M, et al. Valsartan in a Japanese population with hypertension and other cardiovascular disease (Jikei Heart Study): a randomised, open-label, blinded endpoint morbidity-mortality study. Lancet 2007; 369: 1431-1439. Summary | Full Text | PDF(633KB) | CrossRef | PubMed
2 Staessen JA, Richart T. Sum and substance in the Jikei Heart Study. Lancet 2007; 369: 1407-1408. Full Text | PDF(70KB) | CrossRef | PubMed
3 Sawada T, Yamada H, Dahlof B, Matsubara H. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: Kyoto Heart Study. Eur Heart J 2009; 30: 2461-2469. CrossRef | PubMed
4 Yui Y. Concerns about the Jikei Heart Study. Lancet 2012; 379: e48. Full Text | PDF(32KB) | CrossRef | PubMed
5 Retraction of: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study [Eur Heart J (2009) 30: 2461—69, DOI:10.1093/eurheartj/ehp363]. Eur Heart J 2013; 34: 1023. CrossRef | PubMed
a The Lancet, London NW1 7BY, UK

Retraction of: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study

enero 10, 2014

Retraction of: Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study [Eur Heart J (2009) 30:2461–2469, doi: 10.1093/eurheartj/ehp363]

  1. Takahisa Sawada1,
  2. Hiroyuki Yamada1,
  3. Björn Dahlöf2,
  4. Hiroaki Matsubara1,
  5. for the KYOTO HEART Study Group1

  1. 1Department of Cardiovascular Medicine, Kyoto Prefectural University School of Medicine, Kajiicho 465, Kamigyoku, Kyoto 602-8566, Japan

  2. 2Department of Medicine, Sahlgrenska University Hospital/Östra, Göteborg, Sweden

This article has been retracted by the journal. Critical problems existed with some of the data reported in the above paper. The editors of the European Heart Journal hereby retract this paper and discourage citations of it.