Pfizer Settles Trovan Lawsuits

Here at Two Decades & Counting we've been following the legal battles over the Trovan investigations in Nigeria in 1996.  You can review the case and its ramifications in the US legal system here, here, here, and here.  Today Pfizer announced they had settled "lawsuits stemming from" the case for undisclosed sums, with deleterious effects on Pfizer's stock price.

Upcoming Clinical Research Conferences & Events

In about 10 days I will be in San Diego for the first Ethics in Clinical Trials conference.  

Current deals (I think these are still good - call 720-212-0440):

·         4 for 3: Send 4 delegates for the price of 3

·         10% off: Mention booking code leoE11

·         Free Pre-Conference Workshop: preE11  (Led by me, a discussion of emerging region clinical trial ethics) 

Call: 720-212-0440 or click www.ethicsintrials.com.

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Later in March I will be at Partnerships in Clinical Trials in Phoenix - March 30-April 1.  I am chairing a market insight round table discussion on Strategies for Indian Clinical Trials on Thursday Mar 31, at 11:00 AM.  Click here to register, or here for pricing.

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Finally, I will be in a panel discussion at MAGI's Clinical Research Conference in Philadelphia, May 22-25. 

I have attended and presented at the western edition of this conference a couple of years running; this will be the first time I travel east for MAGI. I am delighted to join again with Joan Chambers of CenterWatch, Nye Pelton of Eli Lilly and Marlene Llopiz of Venn Life Sciences to discuss the current state of globalization of clinical trials.

According to the conference organizers, two-thirds of attendees will have 5+ years of experience. About 48% of attendees will be from sites, 27% from sponsors, and 25% from CROs and other service providers.

The conference website is here.  A friend-of-speaker discount can save you $100 - code Q367.

Click here to register. Enter the above discount code when prompted. (Does not apply retroactively or to already-reduced group rates.)

FDA News Roundup

The FDA was in the news a lot this week, an especially noticeable series of events if you have multiple searches returning FDA news each day as I have.  Reviewing my Twitter feed alone (follow me!), I linked to six separate news items about the FDA the last four days:

• Feb 11 - FDA to contract out more foreign inspections from FiercePharma
• Feb 11 - An evidence-free and detail-light op-ed in The Hill's Congress Blog written by Newt Gingrich*, GOP 2012 presidential hopeful; Andrew C. von Eschenbach, former FDA commissioner appointed by Bush 41; and Wayne Oliver, former Georgia Pharmacy Association lobbyist and current head of Gingrich's Center for Health Transformation, a "think-tank" for health care and FDA reform.
• Feb 10 - An op-ed by Rep Joe Pitts (R-PA) claiming that the new proposed FDA medical device regulations are driving innovation and jobs to the EU.
• Feb 10 - FiercePharma again, this time linking to an NYTimes op-ed by Ian D. Spatz, former Merck exec, writing about how direct-to-consumer ads are an important public educational tool that can reduce side effects.
• Feb 9 - a press release from the House Appropriations committee with proposed budget cuts of $220M from FDA's budget for 2011, around 7% of its requested $3.2B in 2010.
• Feb 9 - A Wall Street Journal article noting FDA's concern over six different companies not completing their follow up commitment studies they promised to conduct following accelerated approval of their products.

Bringing all these stories together into some sort of context I leave to others.  One does note that the "over-regulation is hurting business" meme was in heavy rotation this week.

*Newt has been after the FDA for a long time.  In 1994 as Speaker of the House, he advocated "nuking" the FDA altogether and replacing it with a combination of third party reviewers and corporate tax incentives. (Authentic Leadership: Rediscovering the Secrets to Creating Lasting Value, William W. George; Jossey-Bass, 2003)

Offshoring Science

The current issue of IRB: Ethics and Human Research from The Hastings Center has a review of a book I wish I had written, entitled When Experiments Travel: Clinical Trials and the Global Search for Human Subjects, by Adriana Petryna.  Petryna's profile page lists her as an anthropology professor at the University of Pennsylvania. 


The review by Alex John London, professor of philosophy at Carnegie Mellon takes us through Petryna's review of the rise of globalization of clinical trials and discussion of the both the dangers and promise of researchers looking offshore to find trial subjects.  Both London and Petryna point out that because of the power of clinical trials to shape opinions and behaviors of both patients and physicians, not to mention regulators and political forces, researchers must be all the more careful not to place clinical trials of minimally effective experimental remedies into host populations that lack access to the best proven care (to quote the Declaration of Helsinki) or to use willing and unwitting patients to generate information that may have little relevance to the planned consumers of a therapy that will not be made available to the host population.


London seems to derive from his reading something we often talk about in discussion of research ethics, or the lack thereof; namely the highly rare occurrence of one individual intentionally setting out to commit ethically problematic behavior.  Far more commonly, ethical difficulties are the result of a cascade of poor decisions, delegations and skipped steps. Just as airplane crashes are most commonly the result of an accumulation of errors rather than one failed part or decision, so too with researchers and their ethical behaviors.


The IRB publication is available with a paid subscription, but Hastings have made this review available for free on their website, here.  You may have to create an account to see the whole thing. It's worth it.

Ethics in Clinical Trials Conference Now Open

We are about one month away from a conference I am really excited about. Ethics in Clinical Trials will be held on March 2-3 in San Diego at the Hilton San Diego Resort and Spa.  Looks like a lovely place to escape winter for those of you buried under records snows in the US. Click on the conference website above for the details.  Here are a couple of promotions the organizers are generously offering:

•  4 for 3: Send 4 delegates for the price of 3  
• 10% off: Mention booking code leoE11
• Free Pre-Conference Workshop (led by your 2Decades blogger) : preE11

Or just contact the conference organizers, Leo Intelligence at +1-720-212-0440 

If you come to the conference please be sure to come up and say hello - I'd love to meet you in person.