The 2007 Golden Clipboard Awards

  • by: |
  • 12/21/2007
Commenting on the current state of 21st century bioinformatics, Dr. Janet Woodcock quipped that, "Today the major tool of modern medicine seems to the clipboard."

And that gave us an idea – a new award for those who impede (unwittingly or otherwise) the advance of medical progress -- "The Golden Clipboard."

Herewith our 2007 honorees …

Honorable Mention: Representative Rosa DeLauro

An honorable mention goes to Representative Rosa DeLauro for her perplexing efforts to embog the work of the Reagan/Udall Critical Path Foundation. Ms. DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path in general. She has stated: “I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials. The Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy.” This is all the more surprising and concerning considering the fact that Ms. DeLauro chairs the appropriations subcommittee that funds the FDA.

We hope that Ms. DeLauro’s tenacity towards improving the FDA and passion for protecting the public health can be harnessed and redirected to better purposes in 2008.

The Bronze Clipboard: Representative Henry Waxman

A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDA’s sound scientific policy towards “non-inferiority” trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.

In addition to his role as Congressional Oversighter-in-Chief, Mr. Waxman is one of the most knowledgeable members of Congress when it comes to how the FDA works and what it needs to succeed – and we look forward to his efforts to help the agency pursue its mission of both protecting and advancing the public health in 2008.

The Silver Clipboard: Dr. Steven Nissen

Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.” A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.” What’s the frequency, Steve?

Regularly positioning himself as “Dr. Transparency,” Dr. Nissen regularly neglected to come clean about his various consulting arrangements, conflicts and clinical trial activities. That, and his public flailing of as “vile,” earns him this year’s Silver Clipboard and (at least hopefully) removes his name from any plausible consideration for FDA Commissioner anytime in the 21st century.


(Drum roll please …)

2007 Golden Clipboard Winner: Dr. David Graham

David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite “conversations.” Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides. Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint – the same sort of science that, when it came to Vioxx, he rejected as insufficient.

Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,” he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.

For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

Blog Roll

Alliance for Patient Access Alternative Health Practice
Better Health
Biotech Blog
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
Envisioning 2.0
FDA Law Blog
Fierce Pharma
Fresh Air Fund
Furious Seasons
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
In the Pipeline
In Vivo
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
More than Medicine
National Review
Neuroethics & Law
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmacology Corner
Pharmaceutical Business Review
Piper Report
Prescription for a Cure
Public Plan Facts
Real Clear Politics
Shark Report
Shearlings Got Plowed
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog