Why Opening Up Clinical Trials Data Is Good For Pharma Companies Too
By Glyn Moody | Techdirt | November 5, 2013
Earlier this year we wrote about how AbbVie, the pharma company spun out of Abbott Laboratories, had gone to court to stop the European Medicines Agency (EMA) from releasing clinical trials information about one of its drugs. Despite what AbbVie claimed, this was not commercially sensitive in any way, but simply basic data about safety and efficacy.
It’s often overlooked that this data is mostly obtained by testing new drugs on volunteer members of the public who take the medicines in order to establish their safety. By definition, these volunteers are putting themselves at risk. They selflessly offer to do that in order to advance medicine and confer benefits on society as a whole. That means the clinical data obtained from such tests belongs to the public that made them possible, at least from a moral viewpoint.
If a company seeks to prevent the free dissemination of that safety data, as AbbVie is doing in Europe, it is breaking the implicit compact it made with the people who agreed to try out its drugs. Those invited to take part in future trials of AbbVie’s drugs might then begin to ask why they should endanger their health and even lives purely to boost one company’s profits.
But even if AbbVie is resistant to the argument that it has a moral obligation to allow the clinical trials data to be released, and is not concerned that the public might think that it has something to hide, perhaps it will be won over by a recent article in The New England Journal of Medicine, written by four people from the EMA. This puts forward a quite different argument, that releasing test data will directly benefit pharma companies themselves, and offers a number of reasons why.
First, access to the full data sets of completed studies will lead to improvements in the design and analysis of subsequent trials.
Basically, the more information that drug companies have about what works and what doesn’t, the better they can design their future tests.
Second, lessons from past trials about the heterogeneity of treatment effects not only will streamline drug development but also may enhance a drug’s value in the marketplace. Identification of a population with high unmet need in which a new treatment may be more cost-effective than other available treatments can aid sponsors during reimbursement negotiations.
Again, the more information companies have about how different groups of patients responded to a drug, the easier it will be to spot particular sub-groups in the population who derive particular benefit. Selling products for that sub-group will be both easier, more profitable and more ethical than simply trying to sell to everybody, since the drug may be ineffective or even inappropriate for many of the general population.
Third, since several possible treatments for one medical condition are often available, comparative-effectiveness information is important to patients, prescribers, and sponsors seeking to position their products.
For a given condition, there may be several possible treatments. Making clinical test data available allows them to be compared, and the best one selected for future drug development, instead of investing huge sums in what may well be a relatively ineffective approach.
Finally, one of the inherent inefficiencies of data secrecy is the repetition of trials and projects that are doomed from the outset; drug developers may continue to pursue a given target even though clinical trials conducted by others have demonstrated the effort’s futility.
In many ways this is the most important reason. If the results of clinical trials are kept secret, companies run the risk of repeating the mistakes already made by others. Not only is that a waste of time and money that could be better spent on more fruitful avenues, it is putting test subjects at risk unnecessarily. As the NEJM points out:
In at least one documented case, the availability of data from completed trials could have spared trial subjects a potential health risk and saved millions of research dollars.
The article concludes:
A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders. What is sometimes labeled as “free riding” may ultimately pay dividends for innovative companies and for public health. It is ironic that the organizations that most resist wider access to data are the ones that stand to benefit so much from greater transparency.
In fact, this is no mere theoretical possibility. We know this approach works, because it is precisely what we see in the field of open source. Sharing the code freely creates a level playing-field that allows companies to innovate faster because they can build on the work of others. The rise of a multi-billion dollar software industry based around such sharing, and the unprecedented rate of innovation this drives, are yet more reasons that companies like AbbVie should be striving to promote, not prevent, the release and dissemination of clinical trials information as open data.
Follow me @glynmoody on Twitter
Share this:
Related
November 5, 2013 - Posted by aletho | Economics, Timeless or most popular | AbbVie, Biotechnology and Pharmaceuticals, European Medicines Agency, Pharmaceutical industry
No comments yet.
This site uses Akismet to reduce spam. Learn how your comment data is processed.
Featured Video
Politics About the War in Ukraine – Part 16 of The Anglo-American War on Russia
or go to
Aletho News Archives – Video-Images
From the Archives
Magnesium Is a Cornerstone Mineral for Health
This article was previously published April 1, 2019, and has been updated with new information.
By Dr. Joseph Mercola
Magnesium is the fourth most abundant element in your body,1 and one of the seven essential minerals we can’t live without.2 It’s necessary for the healthy functioning of most cells, but especially your heart, kidneys and muscles. Low levels of magnesium impede cellular metabolic function and deteriorate mitochondrial function.
As it is also required for the activation of vitamin D, deficiency may hamper your ability to convert vitamin D from sun exposure and/or oral supplementation. Unfortunately, deficiency is common and research shows even subclinical deficiencies may jeopardize your health. … continue
Blog Roll
-
Join 2,757 other subscribers
Visits Since December 2009
- 6,760,343 hits
Looking for something?
Archives
Calendar
Categories
Aletho News Civil Liberties Corruption Deception Economics Environmentalism Ethnic Cleansing, Racism, Zionism Fake News False Flag Terrorism Full Spectrum Dominance Illegal Occupation Mainstream Media, Warmongering Malthusian Ideology, Phony Scarcity Militarism Progressive Hypocrite Russophobia Science and Pseudo-Science Solidarity and Activism Subjugation - Torture Supremacism, Social Darwinism Timeless or most popular Video War Crimes Wars for IsraelTags
9/11 Afghanistan Africa al-Qaeda Australia BBC Benjamin Netanyahu Brazil Canada CDC Central Intelligence Agency China CIA CNN Colombia Covid-19 COVID-19 Vaccine Da’esh Donald Trump Egypt European Union Facebook FBI FDA France Gaza Germany Google Hamas Hebron Hezbollah Hillary Clinton Human rights India Iran Iraq ISIS Israel Israeli settlement Japan Jerusalem Joe Biden Korea Latin America Lebanon Libya Middle East National Security Agency NATO New York Times North Korea NSA Obama Pakistan Palestine Qatar Russia Sanctions against Iran Saudi Arabia Syria The Guardian Turkey Twitter UAE UK Ukraine United Nations United States USA Venezuela Washington Post West Bank WHO Yemen ZionismRecent Comments
peterjohnarnold on Maybe We Need a New Government… papasha408 on Biden claims Israel ‘has… 5 dancing shlomos on Germany approves plan for… roberthstiver on USS Liberty Massacre: A Pivota… eddieb on USS Liberty Massacre: A Pivota… roberthstiver on Beyond Rafah: What the Zionist… Victor G. on Persecution against Scott Ritt… Unome on Palestinian fired over Gaza ce… Unome on Putin outlines Russian respons… 5 dancing shlomos on Deborah Birx Is Back: Humans a… peterjohnarnold on Scott Ritter Ponders on ‘Real… peterjohnarnold on Palestinian fired over Gaza ce…
Aletho News
- FAUCI FEELS THE HEAT ON CAPITOL HILL
- PCR Testing for Bird Flu ‘Will Only Serve to Raise False Case Count’ Critics Say
- EU Plans Major Expansion of Mass Surveillance
- Maybe We Need a New Government Surveillance Program…
- Israel’s use of rape against Palestinian detainees from Gaza exposed
- Hezbollah air defenses force Israeli jets to turn tail
- Houthis to Try New Hypersonic Missile in Continued Targeting of US Carrier Group
- Biden claims Israel ‘has not invaded Rafah’ as jets, tanks raze city
- The Shameful Journey from “Prelude to Genocide” to “Slow-motion Genocide” to “Rampant Genocide”
- Pipeline v genocide: How Turkiye can legally block oil exports to Israel
If Americans Knew
- Biden policies: Rudderless, incompetent and complicit
- Israeli “precision strike” with US-made weaponry kills 40 Gazans, US assumes good intentions – Day 244
- Cyabra: the Intelligence Cutout Waging Israel’s Online Propaganda War
- How Israeli prison doctors assist in the torture of Palestinian detainees
- “The situation is apocalyptic,” as Israel bombs another UN school – Day 243
- American Media Keep Citing Zaka — though its October 7 atrocity stories are discredited in Israel
- To continue the Gaza genocide, Israel and the US must destroy the laws of war
- As Israel commits yet another war crime in Gaza, Biden still won’t acknowledge it’s happening –Day 242
- Two more US officials resign over Biden administration’s position on Gaza war
- Why Gaza’s Death Toll Is Probably Higher Than Reported
Richie Allen
- Today’s Show Is Cancelled – Back Tomorrow Thursday May 30th
- Call Richie Today Monday March 11th From 4.30pm
- Connect To The Richie Allen Show WhatsApp Today
- NHS Asks Patients To Choose From 12 Genders, 10 sexual Preferences & 159 Religions
- The Richie Allen Show Moves To A New Time Slot From Monday Nov 20th
- Starmer Will Sack Shadow Ministers Who Vote For Gaza Ceasefire
- AI Tool Can Predict Heart Attacks Years In Advance
- Nepal Bans TikTok To Preserve Social Harmony
- Bloke Appointed Boss Of Womb Health Charity
- WHO – “Gaza’s Biggest Hospital Becoming A Cemetery”
No Tricks Zone
- New Study: Western Greenland Was ‘1.5-2°C Warmer Than Today’ During Medieval Warm Period
- Author Of New Paper: No AMOC Collapse…”Should Dissuade People From Climate Doomism”
- The Claim ‘Exxon Knew’ Their Products Induced ‘Catastrophic Climate Impacts’ In The 1970s Is Bunk
- Half Of German E-Car Buyers Regret Their Purchase Or Lease!
- Oops…Cleaner Fuels Mean Less Clouds, More Warming!
- Megafossil Carbon Dating Indicates Sweden Was 2-3°C Warmer Than Today During The Last Glacial
- Met Office Warns: Extremely Wet Summer…After Warning Droughts Would Become More Frequent
- New Study: China’s Loess Plateau 7-8°C Warmer Than Today For Much Of The Last 4000 Years
- German Green Movement “A Run Amok At The Expense Of People And Nature”
- New Study: Warming Temperatures In China The ‘Main Factor’ Explaining Rising Crop Yields
More Links
Contact:
atheonews (at) gmail.com
Disclaimer
This site is provided as a research and reference tool. Although we make every reasonable effort to ensure that the information and data provided at this site are useful, accurate, and current, we cannot guarantee that the information and data provided here will be error-free. By using this site, you assume all responsibility for and risk arising from your use of and reliance upon the contents of this site.
This site and the information available through it do not, and are not intended to constitute legal advice. Should you require legal advice, you should consult your own attorney.
Nothing within this site or linked to by this site constitutes investment advice or medical advice.
Materials accessible from or added to this site by third parties, such as comments posted, are strictly the responsibility of the third party who added such materials or made them accessible and we neither endorse nor undertake to control, monitor, edit or assume responsibility for any such third-party material.
The posting of stories, commentaries, reports, documents and links (embedded or otherwise) on this site does not in any way, shape or form, implied or otherwise, necessarily express or suggest endorsement or support of any of such posted material or parts therein.
The word “alleged” is deemed to occur before the word “fraud.” Since the rule of law still applies. To peasants, at least.
Fair Use
This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more info go to: http://www.law.cornell.edu/uscode/17/107.shtml. If you wish to use copyrighted material from this site for purposes of your own that go beyond ‘fair use’, you must obtain permission from the copyright owner.
DMCA Contact
This is information for anyone that wishes to challenge our “fair use” of copyrighted material.
If you are a legal copyright holder or a designated agent for such and you believe that content residing on or accessible through our website infringes a copyright and falls outside the boundaries of “Fair Use”, please send a notice of infringement by contacting atheonews@gmail.com.
We will respond and take necessary action immediately.
If notice is given of an alleged copyright violation we will act expeditiously to remove or disable access to the material(s) in question.
All 3rd party material posted on this website is copyright the respective owners / authors. Aletho News makes no claim of copyright on such material.
Leave a comment