{"id":43411,"date":"2014-01-28T22:06:13","date_gmt":"2014-01-29T03:06:13","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=43411"},"modified":"2014-01-29T23:09:59","modified_gmt":"2014-01-30T04:09:59","slug":"an-irony-of-pharma-past","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/01\/28\/an-irony-of-pharma-past\/","title":{"rendered":"an irony of pharma past…"},"content":{"rendered":"
This is an excellent article on the state of play with AllTrials in the UK. I left the footnotes in for those who might want to chase the references down. But that’s not the only reason to post it. Maybe across the pond, everyone knows what a Wellcome research fellow is, but the word hasn’t made it to the Georgia [US] mountains. Since Ben Goldacre is such an oft-quoted person, I thought I’d take a look: <\/div>\n
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Improving, and auditing, access to clinical trial results<\/a><\/div>\n
Editorial<\/div>\n
by Ben Goldacre, Wellcome research fellow in epidemiology<\/font><\/a><\/strong><\/div>\n
British Medical Journal<\/font><\/strong> 2014 348:g213<\/div>\n

The House of Commons Public Accounts Committee delivered a remarkable report on 3 January. Its initial remit was the United Kingdom’s £424m [€510m; $697m] stockpile of oseltamivir [Tamiflu], but the committee soon broadened out—with evident surprise—into the ongoing problem of clinical trial results being routinely and legally withheld from doctors, researchers, and patients.<\/p>\n

This situation has persisted for too long. The first quantitative evidence on publication bias was published in 1986.1<\/a> Iain Chalmers described in 2006 how progress in the 1990s soon deteriorated into broken promises.2<\/a> Recent years have seen extensive denial. The Association of the British Pharmaceutical Industry [ABPI] has claimed that these problems are historic, and that results are now posted on clinicaltrials.gov. The recently defunct Ethical Standards in Health and Life Sciences Group,3<\/a> which most UK medical and academic professional bodies signed up to, falsely claimed that a “robust regulatory framework” ensures access to trial results.4<\/a> US legislation requiring all results to be posted on clinicaltrials.gov within 12 months of completion has been widely ignored,5<\/a> with no enforcement. There has also been covert activity from industry—a leaked memo on its “advocacy” strategy included “mobilising patient groups” to campaign against transparency.<\/p>\n

Despite this, we have achieved considerable progress. The AllTrials.net campaign, started 12 months ago, calls for all trials on all uses of all currently prescribed treatments to be registered, with their full methods and results reported.7<\/a> It now has the support of most medical and academic professional bodies as well as the National Institute for Health and Care Excellence [NICE], Medical Research Council, Wellcome, more than 130 patient groups, 60 000 members of the public, and many in industry including GlaxoSmithKline. The Health Research Authority has announced that registration will be a condition of ethics committee approval.8<\/a> The BMA has passed a motion stating that withholding trial results is research misconduct,9<\/a> and the General Medical Council is re-examining its guidance on the matter.<\/p>\n

There have also been extensive new proposals for greater transparency from European Union legislators, the European Medicines Agency [EMA],10<\/a> and industry bodies.11<\/a> All, however, share the same loophole—they all propose improved access to information on trials conducted from 2014 onwards. This means that almost all trials relevant to current medical practice would be exempt [including, for example, those on oseltamivir].<\/p>\n

We now have an unprecedented opportunity for change, with considerable support from medical and academic professional bodies, policy makers, patient groups, and—importantly—the public. It’s time to consider what practical improvements can be made.<\/p>\n

Firstly, by whatever means necessary, the methods and results of all previous trials must be accessible to the medical and academic community, which produces the guidelines and systematic reviews that inform patient care. It is commonly assumed that it would be difficult to enforce demands for trial results from diffuse global organisations, but we have never tried simply asking in an organised fashion. For example, the EMA could ask all research organisations and companies with a marketing authorisation for full methods and results of all trials they have conducted, so that these can be posted online, on the first ever register of trials that aspires to be a complete record of all research. If this invitation is declined, we could be told.<\/p>\n

Secondly, while the current state of secrecy continues, there is much to be done with the most basic research tool in medicine—audit. Industry is quibbling over the precise proportion of trials that go undisclosed. This should not be a matter of debate. We need a trials observatory, covering all trials on all currently used treatments, that matches registry entries and other sources of information on completed trials against sources of results, whether those are in academic papers, clinical study reports, regulatory documents, or online postings. From these data we could derive live dashboards on transparency to drive up best practice, identify the best and worst companies for missing results, the treatments where most information is missing, the best and worst investigators, and more.<\/p>\n

This is actionable information. If routine audit shows a particular principal investigator is performing badly, with many unreported results, should ethics committees grant them access to more trial participants? Will patients participate in trials for companies that withhold results? If two treatments have equivalent benefits, but one comes from a company with a track record of transparency and the other from a company that actively undermines the transparency campaign, are those two treatments still equivalent, and which should a cautious clinician prescribe?…<\/div>\n<\/blockquote>\n
So what’s a Data Transparency advocate, epidemiologist, journalist, psychiatrist like Ben Goldacre doing being supported by  Wellcome? Isn’t that a pharmaeutical conglomerate? Well it was, a pioneer pharmaceutical company founded by an American who went to England and created a pharmaceutical company like no other. They introduced pills [instead of powders], pharma research, detail men. pharmaceutical advertising. Henry Wellcome was a prime mover in the creation of the pharmaceutical industry. He became a true mogul in the process and was one of the great collectors of all times.<\/div>\n
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Biography<\/a><\/h2>\n

Henry Solomon Wellcome<\/strong> was born in a frontier log cabin in Almond, Wisconsin to Rev. S. C. Wellcome, an itinerant missionary who travelled and preached in a covered wagon, and Mary Curtis Wellcome. He had an early interest in medicine, particularly marketing. His first product, at the age of 16, was invisible ink (in fact just lemon juice) which he advertised in the Garden City Herald. He was brought up with a strict religious upbringing, particularly with respect to the temperance movement. His father was a strong member of the Second Adventist<\/span> Church. He was a freemason.<\/p>\n

Pharmaceutical executive<\/h2>\n

In 1880, Henry Wellcome established a pharmaceutical company, Burroughs Wellcome & Company<\/span>, with his colleague Silas Mainville Burroughs<\/span>. They introduced the selling of medicine in tablet form to England under the 1884 trademark "Tabloid"; previously medicines were sold mostly as powders or liquids. They also introduced direct marketing to doctors, giving them free samples. In 1895, Silas Burroughs died, aged 48, leaving the company in the hands of his partner. The company flourished and Henry Wellcome set up several research laboratories linked to the drug company.<\/p>\n

In 1901, Henry Wellcome married Gwendoline Maud Syrie Barnardo<\/span>, a daughter of orphanage founder Thomas John Barnardo. They had one child, Henry Mounteney Wellcome, born 1903, who was sent to foster parents at the age of about three. He was considered to be sickly at the time, and his parents were spending much time traveling.  The marriage was not happy, and in 1909 they separated. After that Syrie had several affairs, including with the department store magnate Harry Gordon Selfridge and William Somerset Maugham<\/span> with whom she had a child [Mary Elizabeth] and later married. Wellcome sued for divorce in 1915, naming Maugham as co-respondent. This attracted large amounts of publicity that he had previously tried to avoid. Syrie never contested Henry’s custody of their child. In 1910, Wellcome became a British subject and was knighted in 1932. In 1924, Wellcome consolidated all his commercial and non-commercial activities in one holding company…<\/p>\n<\/blockquote>\n

With no heirs, he pondered the fate of his wealth and collections…<\/p>\n<\/p><\/div>\n

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Henry Wellcome’s last years<\/a><\/h2>\n

Increasingly lonely, Wellcome spent his last years preparing for his life’s work to be carried on after his death, for the benefit of mankind. Wellcome grew increasingly lonely in the 1910s and 1920s. He had separated from his wife Syrie in 1910 and one by one his close friends – never many in number – grew old and died. In his early 60s he had no one with whom he could share his deepest interests. Even so, his passion for history and collecting remained undimmed. At a time of life when many would slow down, he orchestrated an archaeological dig between 1911 and 1914 in the Sudan, continued rearranging and collecting for his Historical Medical Museum, and opened a museum on the history of medicine. Meanwhile, he remained very much in control of his company, suggesting avenues of research for his scientific laboratories and adapting his enterprises to the strains of World War I. Such was his industry that a member of staff later commented that “one of the things about Sir Henry was that he never thought he would die.”<\/p>\n

Knighthood <\/strong><\/h2>\n

He finally found recognition for his impact on the worlds of business and scientific research in 1932, when he was knighted. Many people were surprised that a man who had done so much for British scientists [and so much for Britain in such a time of need] had had to wait so long before receiving a knighthood. The scandal of his divorce<\/a> is likely to have played a part. In 1932 he was also made an honorary Fellow of the Royal College of Surgeons – a very rare distinction for anyone not holding a medical degree, which indicated the high respect in which he was held by the medical profession. <\/p>\n

Preparations for the future<\/strong><\/h2>\n

With no one to hand over his empire to, Wellcome used his last years to consolidate his various enterprises and make suitable arrangements for mankind to benefit from his life’s work. In 1924, he established The Wellcome Foundation Limited, a private limited company, which brought together his non-commercial and commercial interests under a single corporate umbrella. In 1931, the construction began of the Wellcome Research Institution on Euston Road, designed to house his research laboratories and collections. It was completed in 1932, renamed the Wellcome Building in 1955, and now houses Wellcome Collection. In his will, signed on 29 February 1932, Wellcome vested the entire share capital of his company, The Wellcome Foundation Limited, to the Wellcome Trust. The appointed Trustees would be charged with spending the income according to Sir Henry’s wishes. Four years later, on 25 July 1936, Henry Wellcome died, aged 82, at the London Clinic. He was cremated at Golders Green and in 1987 his ashes were buried in the churchyard of St Paul’s Cathedral…<\/p>\n<\/blockquote>\n

And what came of his company?<\/div>\n
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He founded the pharmaceutical company Burroughs Wellcome & Company<\/a> with his colleague Silas Burroughs, which is one of the four large companies that merged to form <\/font><\/strong>GlaxoSmithKline<\/a>. In addition, he left a large amount of capital for charitable work in his will, which was used to form the Wellcome Trust<\/a>, one of the world’s largest medical charities. He was a keen collector of medical artifacts. <\/div>\n<\/blockquote>\n
The ironies in this story are too numerous to count. That a leading Data Transparency activist is a Wellcome research fellow in epidemiology<\/font><\/a><\/strong> is just a notable fact – Goldacre leading a fight against the misadventures of the pharmaceutical industry Henry Wellcome put on the map, negotiating with GSK, the heir to Wellcome’s company. That just has to be interesting piece of history – whether it means anything or not – and a fine thing to nose around in on a snowed in evening in Dixie…<\/div>\n","protected":false},"excerpt":{"rendered":"

This is an excellent article on the state of play with AllTrials in the UK. I left the footnotes in for those who might want to chase the references down. But that’s not the only reason to post it. Maybe across the pond, everyone knows what a Wellcome research fellow is, but the word hasn’t […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-43411","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/43411","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=43411"}],"version-history":[{"count":28,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/43411\/revisions"}],"predecessor-version":[{"id":43506,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/43411\/revisions\/43506"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=43411"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=43411"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=43411"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}