{"id":38914,"date":"2013-08-03T10:27:06","date_gmt":"2013-08-03T14:27:06","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=38914"},"modified":"2013-08-07T20:48:45","modified_gmt":"2013-08-08T00:48:45","slug":"the-spice-must-flow","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2013\/08\/03\/the-spice-must-flow\/","title":{"rendered":"the spice must flow…"},"content":{"rendered":"
About the time Iwas heading out of town, the British Medical Journal published a head-to-head debate between Ben Goldacre and John Castellani from PhRMA on Data Transparency. Since most know Ben’s arguments, I thought I’d post the other side to look at what they have to say: <\/div>\n
\n
Are clinical trial data shared sufficiently today? Yes<\/a><\/div>\n
Head to Head<\/font><\/strong><\/div>\n
by John Castellani<\/div>\n
President and CEO, Pharmaceutical Research and Manufacturers of America [PhRMA]<\/div>\n
British Medical Journal<\/font><\/strong>. 2013 347:f1881.<\/div>\n

Clinical trials are essential for the successful development of new medicines that save and improve lives and provide hope for millions of patients. Biopharmaceutical companies are committed to the continuous improvement of clinical trials to bring innovative medicines to the patients who need them. This includes protecting the safety of study participants, overcoming barriers to greater participation, and fostering new medical discoveries. The biopharmaceutical industry is firmly committed to enhancing public health through responsible reporting and publication of clinical research and safety information. In the process of drug development, companies routinely publish their research, collaborate with academic researchers, and disclose clinical trial information at the time of patient registration, drug approval, and for medicines whose research programs have been discontinued. In addition, PhRMA has set out voluntary principles to fortify biopharmaceutical companies’ commitment to the highest standards for ethics and transparency in the conduct of clinical trials. PhRMA’s Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results<\/em> are designed to help ensure that clinical research conducted by biopharmaceutical research companies continues to protect patients and provide meaningful medical research results to healthcare professionals and patients.<\/p>\n

The biopharmaceutical sector may provide more information about its research and products than any other industry. As expected by the healthcare professionals that prescribe innovative medicines, the current biomedical research system includes wide sharing of trial results with government regulators, academic and medical communities, and physicians through submissions to the US Food and Drug Administration [FDA] and other international regulatory bodies, presentations at medical conferences, and publication in peer reviewed journals. Information on clinical trials for potential new medicines is already required by US law to be posted on ClinicalTrials.gov, the publicly accessible clearing house maintained by the National Institutes of Health [NIH]. As of May 2013, ClinicalTrials.gov has information on 146 213 studies in all 50 states and in 185 countries. NIH reported last year that ClinicalTrials.gov “receives more than 95 million page views per month and 60 000 unique visitors daily.”<\/p>\n

While these efforts are working, the biopharmaceutical industry is engaged in a dynamic ongoing process to improve on all aspects of clinical trials and is committed to taking part in a multi-stakeholder dialogue to advance responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research. We are reaching out to groups such as the Institute of Medicine, the Harvard Multi-Regional Clinical Trial Center, Project Data Sphere of the CEO Roundtable on Cancer, and the European Alliance for Personalized Medicine. Processes for data sharing or disclosure must take account of patients’ informed consent and the reality that re-identification of patients based on anonymized information is possible. Threats to patient privacy will jeopardize patient willingness to participate in clinical trials, which would delay the availability of new therapies.<\/p>\n

Dumping millions of pages of clinical trial information into the public domain without providing appropriate scientific and clinical context or guidelines for meta-analysis could lead to second guessing of the expert decisions of national regulators worldwide, undermining patient trust and confidence in the safety and effectiveness of approved medicines. Mandatory public disclosure of intellectual property, confidential commercial information, and proprietary scientific methods found in clinical trials could stifle discovery and open the possibility of competitors or unscrupulous actors using the information for their own products in other markets or countries. Without appropriate protection for intellectual property to incentivize the enormous investment risk involved, biopharmaceutical companies will be discouraged from investing in the next generation of new medicines, leading to patients and physicians being deprived of innovative therapies to tackle the serious and life threatening diseases of the 21st century.<\/p>\n

The modern clinical trial system and associated sharing of information led to more than 340 new medicines approved by the FDA over the past decade, with 39 new medicines in 2012 alone. It contributed to over 30 new medicines approved for HIV in the past three decades—based on the work of 2400 completed trials—turning what was once a death sentence into a treatable, chronic condition. Since 2000, PhRMA member companies have invested about $550bn [£330bn; €390bn] in research and development, including clinical trials, in the search for new treatments and cures. No government or academic institution has the resources or multidisciplinary expertise to conduct the clinical trials needed to develop the new medicines patients need. Only the biopharmaceutical industry can take on this considerable risk at such a scale, and only a carefully balanced regulatory and competitive environment can foster the future investments in this research necessary to produce new treatments to benefit current and future patients.<\/div>\n<\/blockquote>\n
Frank Herberts classic, Dune<\/a>, is the all-time best selling science fiction novel in which the ruling Houses fight for control of the desert planet Arrakis, the only source for the Spice – a drug derived from the giant worms that roam the planet. The Spice is the most valuable substance in the universe – the organizing principle of politics, science, commerce, and religion. The one truth never questioned in the novel is that "the Spice must flow.<\/font><\/strong><\/em>" I think of that novel when I read something like this treatise from PhRMA which sounds like life reproducing art to me – particularly when it comes to psychiatric medications. <\/div>\n

Unfortunately, I also think of that novel when I read Dr. Lieberman’s article in the Psychiatric News discussed in the last two posts [all better now?…<\/a>, the wrong we<\/font><\/u>…<\/a>]. His logic is very similar ["the Spice must flow<\/font><\/strong><\/em>"]. It’s the music of both articles. And Castellani’s article needs some music, because his words make no sense. Data transparency offers no real challenge to subject anonymity. There are no proprietary secrets at stake. There’s just the truth about the efficacy and the adverse effects of the medications, at least as much truth as short clinical trials can reveal. And if we know that truth about efficacy and adverse effects, we’ll prescribe less, and patients will take less medication. Castellani’s article contains a threat. If we restrict industry by making clinical trial results available for independent evaluation, they’ll stop pouring money into research and the medical enterprise. That will create a genuine and difficult problem. It already has. But it’s one better dealt with directly than by creating an unholy alliance with the pharmaceutical industry. <\/p>\n

In a comment<\/a> on all better now?…<\/a>, Psycritic<\/font><\/strong> reminds us of something Dr. Lieberman said recently:<\/div>\n
\n
I think this quote from Lieberman’s 06\/25\/13 article<\/a> in Psychiatric News about his experience at the White House Mental Health Conference says it all:<\/div>\n
    \n
    Don’t get me wrong: the conference represented, to my mind, the most important and significant presidential effort on behalf of mental health care since Rosalynn Carter’s White House Conference on Mental Illness over 30 years ago. But there were things about it that gave me pause. The tenor and content of the meeting were not as medically oriented or scientifically based as I would have liked. The presentations and discussions got a little too “touchy feely” at times, and the overall focus seemed more on social-science approaches to mental health care than biomedical or neuroscience perspectives.<\/em><\/div>\n<\/ul>\n
    Sigh. When the biomedical perspective on mental health is all you have, how can you avoid turning to pharma?<\/div>\n<\/blockquote>\n
    Well said. And we could add that if the force driving drug development by the pharmaceutical industry is their right to keep important medical information behind a proprietary firewall, how can we practice decent medicine?  No matter how many billions pharma throws at research and medical education, we  can’t honestly advise our patients about the use of medications without that information. That clinical trial has been done and the results are readily apparent to all of us. John Castellani and the organizations he represents need a business model that’s bigger than "the Spice must flow<\/font><\/strong><\/em>". It’s really that simple…<\/div>\n","protected":false},"excerpt":{"rendered":"

    About the time Iwas heading out of town, the British Medical Journal published a head-to-head debate between Ben Goldacre and John Castellani from PhRMA on Data Transparency. Since most know Ben’s arguments, I thought I’d post the other side to look at what they have to say: Are clinical trial data shared sufficiently today? Yes […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","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_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-38914","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/38914","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=38914"}],"version-history":[{"count":33,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/38914\/revisions"}],"predecessor-version":[{"id":40436,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/38914\/revisions\/40436"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=38914"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=38914"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=38914"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}