Why Opening Up Clinical Trials Data Is Good For Pharma Companies Too

from the everybody-wins dept

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 (NEJM), 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 or identi.ca, and +glynmoody on Google+

Filed Under: , , , ,
Companies: abbvie

Rate this comment as insightful
Rate this comment as funny
You have rated this comment as insightful
You have rated this comment as funny
Flag this comment as abusive/trolling/spam
You have flagged this comment
The first word has already been claimed
The last word has already been claimed
Insightful Lightbulb icon Funny Laughing icon Abusive/trolling/spam Flag icon Insightful badge Lightbulb icon Funny badge Laughing icon Comments icon

Comments on “Why Opening Up Clinical Trials Data Is Good For Pharma Companies Too”

Subscribe: RSS Leave a comment
8 Comments
Anonymoussays:

“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.”

That is precisely why they don’t want this data available.

Their new ‘ever-greened’ drug is just as effective as the older, cheaper, generic version. I wonder which one I would buy?

out_of_the_bluesays:

Pieces like this are always disconnected from reality.

This piece fosters the demonstrably false notion that pharmaceutical mega-corporations care about efficacy at all, let alone over profits.

The only real question raised is “fool or knave”: whether these Pollyannas actually believe idealistic notions that corporations are interested in doing good, or are cynical hacks grinding out standard PR as part of the massive advertising machine (that has as its goal excess and unnecessary drug use).

“We know this approach works, because it is precisely what we see in the field of open source.” — HA! False analogy (as all are), and hopelessly naive: you’re comparing for-profit mega-corporations to people writing non-profit code? Sheesh. Up to that point, I gave you benefit of doubt, but when you stretch that far…

Since to even argue these notions, one must ignore the long record of pharmaceutical mega-corporations putting profits over not just efficacy but patients lives, I regard these as yet more fools who believe they’re knaves, but are actually just tools of the real knaves.


Actual user testimonial: Techdirt helps me think right because provides an obviously wrong reference point.

01:37:06[b-370-6]

Add Your Comment

Your email address will not be published. Required fields are marked *

Have a Techdirt Account? Sign in now. Want one? Register here

Comment Options:

Make this the or (get credits or sign in to see balance) what's this?

What's this?

Techdirt community members with Techdirt Credits can spotlight a comment as either the "First Word" or "Last Word" on a particular comment thread. Credits can be purchased at the Techdirt Insider Shop »

Follow Techdirt

Techdirt Daily Newsletter

Techdirt Insider Discord
The latest chatter on the Techdirt Insider Discord channel...
Loading...
Older Stuff
13:40 It's Great That Winnie The Pooh Is In The Public Domain; But He Should Have Been Free In 1982 (Or Earlier) (35)
12:06 Norton 360 Now Comes With Crypto Mining Capabilities And Sketchy Removal Process (28)
10:45 Chinese Government Dragnet Now Folding In American Social Media Platforms To Silence Dissent (14)
10:40 Daily Deal: The 2022 Ultimate Cybersecurity Analyst Preparation Bundle (0)
09:29 A Fight Between Facebook And The British Medical Journal Highlights The Difficulty Of Moderating 'Medical Misinformation' (9)
06:29 Court Ruling Paves The Way For Better, More Reliable Wi-Fi (4)
20:12 Eighth Circuit (Again) Says There's Nothing Wrong With Detaining Innocent Minors At Gunpoint (15)
15:48 China's Regulatory War On Its Gaming Industry Racks Up 14k Casualties (10)
13:31 Chinese Government Fines Local Car Dealerships For Surveilling While Not Being The Government (5)
12:08 Eric Clapton Pretends To Regret The Decision To Sue Random German Woman Who Listed A Bootleg Of One Of His CDs On Ebay (29)
10:44 ICE Is So Toxic That The DHS's Investigative Wing Is Asking To Be Completely Separated From It (29)
10:39 Daily Deal: The 2022 Complete Raspberry Pi And Arduino Developer Bundle (0)
09:31 Google Blocked An Article About Police From The Intercept... Because The Title Included A Phrase That Was Also A Movie Title (24)
06:22 Wireless Carriers Balk At FAA Demand For 5G Deployment Delays Amid Shaky Safety Concerns (16)
19:53 Tenth Circuit Denies Qualified Immunity To Social Worker Who Fabricated A Mother's Confession Of Child Abuse (35)
15:39 Sci-Hub's Creator Thinks Academic Publishers, Not Her Site, Are The Real Threat To Science, And Says: 'Any Law Against Knowledge Is Fundamentally Unjust' (34)
13:32 Federal Court Tells Proud Boys Defendants That Raiding The Capitol Building Isn't Covered By The First Amendment (25)
12:14 US Courts Realizing They Have A Judge Alan Albright Sized Problem In Waco (17)
10:44 Boston Police Department Used Forfeiture Funds To Hide Purchase Of Surveillance Tech From City Reps (16)
10:39 Daily Deal: The Ultimate Microsoft Excel Training Bundle (0)
09:20 NY Senator Proposes Ridiculously Unconstitutional Social Media Law That Is The Mirror Opposite Of Equally Unconstitutional Laws In Florida & Texas (25)
06:12 Telecom Monopolies Are Exploiting Crappy U.S. Broadband Maps To Block Community Broadband Grant Requests (7)
12:00 Funniest/Most Insightful Comments Of 2021 At Techdirt (17)
10:00 Gaming Like It's 1926: Join The Fourth Annual Public Domain Game Jam (6)
09:00 New Year's Message: The Arc Of The Moral Universe Is A Twisty Path (33)
19:39 DHS, ICE Begin Body Camera Pilot Program With Surprisingly Good Policies In Place (7)
15:29 Remembering Techdirt Contributors Sherwin And Elliot (1)
13:32 DC Metro PD's Powerful Review Panel Keeps Giving Bad Cops Their Jobs Back (6)
12:11 Missouri Governor Still Expects Journalists To Be Prosecuted For Showing How His Admin Leaked Teacher Social Security Numbers (39)
10:48 Oversight Board Overturning Instagram Takedown Of Ayahuasca Post Demonstrates The Impossibility Of Content Moderation (10)
More arrow
This site, like most other sites on the web, uses cookies. For more information, see our privacy policy. Got it