GlaxoSmithKline to publish clinical trials after US lawsuit
http://www.100md.com
《英国医生杂志》
The world's second largest pharmaceutical company, GlaxoSmithKline, is to publish summaries of the results of all its clinical trials on its website once a product has been launched.
GlaxoSmithKline said it has been considering the move for several months now, but it follows on the heels of a US lawsuit, filed by Eliot Spitzer, New York state's attorney general, earlier this month.
Mr Spitzer alleged the company engaged in "repeated and persistent fraud" for concealing the results of clinical studies for its antidepressant paroxetine; these suggested the drug was ineffective and unsafe in treating depression in children and adolescents (12 June, p 1395).
Mr Spitzer also had an internal memo (dated 1998) from GlaxoSmithKline's predecessor company, SmithKlineBeecham, which said that it would be "commercially unacceptable" to admit the results. This document was published in the Canadian Medical Association's journal, CMAJ, earlier this year and reported in the BMJ (21 February, p 422).
A GlaxoSmithKline spokesperson said the company decided to undertake the move now to increase transparency in clinical trials and to restore trust in research undertaken by the pharmaceutical industry.
A few days before the announcement, GlaxoSmithKline had already published full reports (including raw data) of eight trials of paroxetine in children on its website. Although paroxetine is not licensed for use in children, it has been used off label. Last year, the United Kingdom contraindicated its use in these groups while the United States issued warnings.
Mr Spitzer described GlaxoSmithKline's actions as a "positive step": "The availability of this information is in the best interest of the consumer. We will continue our efforts to change industry practice in this area." However, he added that it would not resolve all of the issues in the lawsuit.
Tadataka Yamada of GlaxoSmithKline said the trial register "will be a major advance"
Credit: GSK
The lawsuit has also raised an old topic—publication bias towards negative trial results, which has long been debated by academic circles—and brought it into the mainstream. Last week the American Medical Association urged the US Department of Health and Human Services to set up a public registry on clinical trials after the Spitzer lawsuit.
The database, to be called the GSK Clinical Trial Register, will be accessible to doctors and the public in the third quarter of this year. It will be gradually built, as the company has some 49 products, but it is envisaged that it will include all clinical trials (phase I to phase IV) and data on efficacy and safety.
Tadataka Yamada, GlaxoSmithKline's chairman of research and development, said: "The GSK Clinical Trial Register will be a major advance in providing online access to information to support patient care, facilitating access to study summaries by putting them on a single internet site."
Other companies have not been so forthcoming. In May 2003 the UK trade body, the Association of the British Pharmaceutical Industry (ABPI), launched its own clinical trial register, which publishes basic information on trial protocols, but no data on trial results. However, fewer than 10 pharmaceutical companies participated in this project (GSK did not take part).(Liza Gibson)
GlaxoSmithKline said it has been considering the move for several months now, but it follows on the heels of a US lawsuit, filed by Eliot Spitzer, New York state's attorney general, earlier this month.
Mr Spitzer alleged the company engaged in "repeated and persistent fraud" for concealing the results of clinical studies for its antidepressant paroxetine; these suggested the drug was ineffective and unsafe in treating depression in children and adolescents (12 June, p 1395).
Mr Spitzer also had an internal memo (dated 1998) from GlaxoSmithKline's predecessor company, SmithKlineBeecham, which said that it would be "commercially unacceptable" to admit the results. This document was published in the Canadian Medical Association's journal, CMAJ, earlier this year and reported in the BMJ (21 February, p 422).
A GlaxoSmithKline spokesperson said the company decided to undertake the move now to increase transparency in clinical trials and to restore trust in research undertaken by the pharmaceutical industry.
A few days before the announcement, GlaxoSmithKline had already published full reports (including raw data) of eight trials of paroxetine in children on its website. Although paroxetine is not licensed for use in children, it has been used off label. Last year, the United Kingdom contraindicated its use in these groups while the United States issued warnings.
Mr Spitzer described GlaxoSmithKline's actions as a "positive step": "The availability of this information is in the best interest of the consumer. We will continue our efforts to change industry practice in this area." However, he added that it would not resolve all of the issues in the lawsuit.
Tadataka Yamada of GlaxoSmithKline said the trial register "will be a major advance"
Credit: GSK
The lawsuit has also raised an old topic—publication bias towards negative trial results, which has long been debated by academic circles—and brought it into the mainstream. Last week the American Medical Association urged the US Department of Health and Human Services to set up a public registry on clinical trials after the Spitzer lawsuit.
The database, to be called the GSK Clinical Trial Register, will be accessible to doctors and the public in the third quarter of this year. It will be gradually built, as the company has some 49 products, but it is envisaged that it will include all clinical trials (phase I to phase IV) and data on efficacy and safety.
Tadataka Yamada, GlaxoSmithKline's chairman of research and development, said: "The GSK Clinical Trial Register will be a major advance in providing online access to information to support patient care, facilitating access to study summaries by putting them on a single internet site."
Other companies have not been so forthcoming. In May 2003 the UK trade body, the Association of the British Pharmaceutical Industry (ABPI), launched its own clinical trial register, which publishes basic information on trial protocols, but no data on trial results. However, fewer than 10 pharmaceutical companies participated in this project (GSK did not take part).(Liza Gibson)