It would be difficult to overstate our admiration for the National Library of Medicine (NLM).
As many readers know, the NLM is a component of the National Institutes of Health. The NLM built several international treasures, including PubMed and GenBank and more. If you use BLAST, or do literature searches, you depend on the NLM. Their databases aren't the bedrock for the life sciences in the 21st century. They're the rock that holds up the bedrock. What portion of the U.S. economy is tied in some manner to the NLM? Could there be a more beneficial use of federal funds?
This is all to lead into the fact that Bio-IT World recently had the pleasure to interview an obscure (and doomed) hero of the NLM. Deborah Zarin is the new director of ClinicalTrials.gov.
Zarin, it should be said, is not doomed because of any inherent flaw on her part; she has none that we are aware of. Rather, ClinicalTrials.gov will be quietly denied both money and statutory authority to be anything more than what it is at present. Which is a search engine to help patients find a few suitable NIH-sponsored clinical trials.
In brief, the U.S. Congress is unlikely to be bright enough to understand that expanding ClinicalTrials.gov into a clinical cousin of GenBank would actually be healthy for the industry and the public.
The U.S. Congress will not be sufficiently smart or visionary to create a broad, mandatory, scientifically useful repository for clinical trial data. Yes, the world needs an easily searchable mother lode of clinical trial data. And we are unlikely to get one. Perhaps three percent of all trials now find their way into ClinicalTrials.gov. This is a glaring gap in the informational foundation that supports medical and scientific progress.
As Zarin explained in admirably neutral, muted, and measured language, Congress created uncertainty about what must be deposited in ClinicalTrials.gov. Without Congressional clarification of terms like "severe and life-threatening," and without mandatory deposition of all clinical data into one public repository, society and the research community will remain in the dark about drugs.
Just to be clear, that's eCliniqua's view, not Zarin's. She is (as far as we can tell) devoid of strong opinions and obliged to do whatever is in the law. Our hunch is that Congress, conservatively, will need a decade or more to understand that its present approach has indulged but damaged a vital U.S. industry.
Why? A corrosive cocktail of more lawsuits, less public trust, and greater regulation will follow once the industry's practice of delaying and suppressing the publication of unflattering clinical trial data becomes more widely understood.
Remember when the tobacco companies somberly insisted that their products did not cause lung cancer? It wasn't that long ago. The comparison only goes so far, but that's where we are today in pharma. Drug companies today insist they publish all their clinical data immediately. On their own websites! Right.
A proactive, forward-looking pharmaceutical industry is foolish to stonewall an expanded and improved ClinicalTrials.gov. An improved database, over time, would be a resource that would pay for itself many times over, just as PubMed and GenBank have. A better database for clinical trial data would go a long way to increase confidence in the industry among insurers, physicians, and the public. It would elegantly demonstrate - with deeds, not public relations - the considerable care and delicacy with which the industry undertakes every experiment on living human beings.
That's our one contractually permitted outburst for the week - a transcript of Zarin's more judicious remarks can be found here.
Call for Presentations|
2005 Bio-IT World Venture Forum
One of the highlights of the upcoming Bio-IT World Conference + Expo (May 17-19, 2005) will be the Venture Forum, hosted by Ernst & Young and IDG Ventures. This program will include industry overviews from Bryan Pearce (Ernst & Young) and Jim Golden (SAIC), and a panel of leading technology buyers from some of the most prestigious biopharma organizations.
The organizers of this year's Venture Forum are inviting applications to present at the Forum from young bio-IT/biopharma technology providers. If you:
represent an exciting young company in areas including, but not limited to, software, grid computing, and instrumentation;
are seeking to raise $2-$20 million in the next one to two years; and
would like the opportunity to showcase your organization and expertise at the 2005 Venture Forum,
please download the application or contact: Kate Greene, IDG World Expo, Ph: 508-424-4815, Email: email@example.com.
The application deadline is February 25, 2005.