Two new additions to our Board of Directors

We're pleased to announce the addition of Warner Slack, M.D., and Edward Hundert, M.D., to our Board of Directors. Both of these distinguished clinician-educators share our vision for a fully transparent, non-commercialized source of clinical trials information and opinion.

We are fortunate to count them among the Clinical Trials Wiki family.

Full bios of each new Board member will be posted shortly on this blog and our main site, ClinicalTrialsWiki.org.

Health IT: the new Apollo program?

Yesterday, Mark Leavitt over at THCB compared the portion of Obama's "American Recovery and Reinvestment Act" dealing with electronic health records (EHR) to Kennedy's program to send a man to the moon. Sound far-fetched?

Here's the quote (full article after the jump):

I’m personally struck by the parallels to a historical event still vivid in my memory: Project Apollo, President Kennedy’s incredible national goal of achieving manned spaceflight to the moon.

Apollo cost $22B (in 1969 dollars, now worth five times that) and took 8 years to achieve the first moonwalk. NASA, a new government agency, spearheaded the effort, but the technology was developed by private sector contractors.

The health IT provisions of ARRA invest at least $35B to incentivize full EHR deployment, allowing 5-7 years to reach that goal – remarkably similar to Project Apollo. The Office of the National Coordinator (ONC) has been codified and funded to lead the effort, and just as in the case of Apollo, I expect much of the work will need to be accomplished by contractors in the private sector -- CCHIT included, of course, provided we quickly “grow up” to meet the enlarged responsibilities.

While EHR won't induce the sort of national high drama that the Apollo program did (I can see eyeballs rolling already...), Mark does have a point about the similar scale and impact of the two projects. Arguably, EHR will actually have far greater impact, through the improved patient outcomes that result from increased accessibility, consistency, and comprehensiveness of our new health records.

Yet until recently, EHR was hardly brought up in the national discourse about high-impact fixes to improve health care. James Holsinger, in all his bespectacled charm, never once mentioned the issue during his prolonged confirmation process for U.S. Surgeon General in '07.

As Mark rightly points out, the thorniest issues surround adoption of new EHR technologies -- getting a physician to give up old patterns of behavior (see NHS's initiative in England to banish white coats) may prove harder than shooting the moon.

Our new Facebook home

Yesterday morning, I created a new Facebook group to coincide with the launch of our new website. So far it's Gaurav, myself, and 12 good friends. Brice, we think, is trapped in the bowels of the ICU and hasn't had a chance to join yet!

Here's how we describe ourselves on Facebook:

ClinicalTrialsWiki.org strives to be the most trusted source of clinical trials information online. You can search our database of analysis and opinion on over 65,000 clinical trials.

We're structured as a 100% volunteer-run, 501(c)(3) nonprofit and, as a policy, we don't accept ads or money from the pharmaceutical and medical device industries.

That's all there is to it -- no ads, no gimmicks, and no tricks up our sleeve.

The site was developed by three friends at Harvard Medical School and M.I.T.

We'd love to see you join our community!

Whew!

I think I speak for the entire team at ClinicalTrialsWiki.org when I say that we're thrilled to have a new, far more functional site go live today. Everyone here has been working feverishly over the last 72 hours to get this work done, though it's just the beginning.

To his credit, Brice has been on call in the ICU and several times decided to get work done with us post-call instead of going to sleep. And this weekend, Gaurav heroically led our webcrawler development effort though his new fiancee flew into town for the weekend! Both of my teammates continue to inspire me with their passion for this project.

Here are a few highlights of our achievements over the last few days:

• We designed and implemented a Wikibot to automate the extraction of data from ClinicalTrials.gov
  
• We laid out a brand new format for our clinical trials 'data' page
• We decided on a new logo, color scheme, and website layout
• We met with friends and colleagues at HMS, the Countway medical library, and HealthMap to get feedback on our ideas and refine our thinking about the site
• We've set up meetings with NEJM and FDA to discuss possible partnership and site integration

Every minute as I write this, our crawler is adding 5-10 new fully populated clinical trials to our site. Look for even more changes to come, particularly as we enhance the usability of the wiki features of the site, so that anyone on the web can edit articles and upload data files.

We're committed to being 100% transparent with you about how we develop and maintain our site. We know you might have ideas about where we should go from here, and we want to hear from you.

WikiBot is Online

After a weekend of hacking php (and with the help of the fantastic source code of BasicBot), we've finished our first database-browsing, wiki-populating, automated bot which will populate the wiki with content and expert pages for all 65,000 trials on the clinicaltrials.gov database. The bot is chugging along diligently, and we expect to have completed the population process by mid-week.

In the future, we're planning on creating a multi-threaded bot that will speed up the process tremendously, as well as limiting updates to new or revised content from clinicaltrials.gov. For now, we're just excited that we'll soon have more content than we'll know what to do with -- ready and waiting for your discussion and analysis!

On the aesthetics front, we're continuing to modify the layout of individual content pages to make it as easy as possible to navigate the plethora of data and find the information you're looking for. As always, we'd love your feedback and suggestions.

If you're curious, you can see the trials being added in real-time by the bot on the "New Pages" list.

Version 2.0 is Live!

ClinicalTrialsWiki.org has finally gotten a much-needed aesthetic overhall -- the first of many revisions, I am sure. It's a work in progress, so please leave your feedback.

We're also putting the final touches on an automated PHP crawler bot that will keep every trial on ClinicalTrialsWiki in sync with the ClinicalTrials.gov repository, and ensure that all of the information is up-to-date.

Things are exciting around here, and I can feel the momentum building!

Supreme Court rules on different standards for drug and device makers

Does a patient who's undergone implantable cardioverter-defibrillator (ICD) placement, and whose ICD's electronic components have now failed -- requiring emergent device replacement -- have the right to sue the cardiac device's maker for negligence, if he was repeatedly warned by his cardiologist of the well-known risk of post-implantation electronics failure?

Device makers have long argued 'No': every device has risks, and the FDA-CDER premarket approval process is designed to weigh risk against benefit before permitting the introduction of a new device. The Supreme Court last year substantially agreed with this view in Reigel v Medtronic by ruling that successfully obtaining premarket approval from the FDA gives medical device makers (in this case, Medtronic, a manufacturer of ICDs) a strong defense against lawsuits filed in state courts because federal regulation "pre-empts" state law here.

Today, under presumably different logic, the court ruled in Wyeth v. Levine that drug makers can be sued in state courts, even when they have obtained FDA approval.

So why the discrepancy? The Wall Street Journal Health Blog reports on the issue today:

The 8-1 ruling in the medical device case, Riegel v. Medtronic, relied heavily on the “Medical Device Amendments” signed into law in 1976.

As the court wrote in Riegel:

The MDA provides that no State ‘may establish or continue in effect with respect to a device . . . any requirement’ relating to safety or effectiveness that is different from, or in addition to, federal requirements …

That language goes to the heart of preemption, the legal question at issue in both cases: Does federal regulation override state law? In the case of devices, the court found, MDA explicitly preempts state law.

But the MDA is all about devices, while the case decided today, Wyeth v. Levine, is all about drugs. The relevant drug law is the Food, Drug, and Cosmetic Act, enacted in 1930 and amended several times in the decades since then.

Amendments added in 1962 indicated “that a provision of state law would only be invalidated upon a ‘direct and positive conflict’ with the FDCA,” Justice Stevens wrote in his majority opinion in Wyeth v. Levine.

What’s more, Stevens added, “when Congress enacted an express pre-emption provision for medical devices in 1976″ — in the MDA — “it declined to enact such a provision for prescription drugs.”

The notion of pre-emption gets to the very heart of our national experiment with federalism, and makes for a fascinating legal discussion. But it's unfortunate for most Americans that this case hinged on the issue of pre-emption, rather than addressing the broader social ramifications of an increase in state and federal drug lawsuits in our already litigation-littered society.

Something just doesn't sit well with me about our asymmetric policy for dealing with device and drug companies (largely for historic reasons related to the recency of most device legislation, and the relative strength of industry lobbying groups). We've long been doing this to our detriment, I think, in the FDA's 510K process of rapidly approving "substantially equivalent" devices.

Medical device and pharmaceutical companies face enormous legal liability and financial risk in developing the innovative therapies that physicians and patients rely upon.

So there's a few reasons why I agree with the Court's original decision in Reigel v Medtronic:

• First, mitigating the legal liability to device companies removes downward pressure on innovation;
• Second, the tort system in our country is badly broken, with punitive damages awarded by juries in many cases exceeding the pale of reason;
• Third, I'm hoping this decision will spur legislation to give FDA broader oversight and stricter controls over device development and postmarketing surveillance.

If we're answering the question of whether the companies have been negligent, and we ask -- did their actions "cause" the damages suffered, and could a "reasonable person forsee the harm" to the patient in this case? -- then I think the answer to both questions is yes.

However, drugs and devices, by virtue of their intimate relationship with our bodies, have the potential to cause immense, sometimes irreversible, harm. We can predict, and warn about the dangers of, this harm by conducting preclinical and clinical trials.

Our regulatory process should (in the ideal world) weed out those drugs or devices whose risk/benefit profile is tipped towards risk, and protect companies and physicians who adequately educate patients about that risk prior to starting treatment. Otherwise life-saving therapies would never see the light of day for fear of a class-action lawsuit.