Oh, the vagaries of a hot Washington summer. Between the heat, humidity and mosquitoes is it any wonder that we gather friends and family and head for the beach to escape the city's oppression?
If Dr. Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research (CDER), leaves the District to summer on the shore, my guess is her beach rental will be packed with drug industry executives. These days, it seems like some of Janet's closest buddies are the boys and girls at Big Pharma.
To FDA insiders, she’s one of their most ardent advocates, particularly when it comes to conflict of interest standards for FDA advisory board members. And so yesterday, POGO sent a letter to FDA Commissioner Margaret Hamburg urging her not to weaken the agency’s conflict of interest standards, by focusing on facts and not what appears to be Dr. Woodcock’s personal opinions.
Even before Obama stepped foot in the White House, the drug industry began floating Dr. Woodcock’s name for FDA Commissioner in the pages of The Wall Street Journal. This vexed Congressman Bart Stupak (D-MI) who sent the President-elect an angry letter.
"Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for,” Stupak wrote, without naming Dr. Woodcock directly.
In recent months, Janet has been blowing kisses back to drug executives who are irritated that new conflict of interest rules are limiting their ability to place their paid-for experts on FDA’s safety panels. Last May, she told reporters that financial conflict of interest rules made it "tough to find knowledgeable people" to serve on advisory panels that make recommendations on drug safety.
"It's a concern for all our staff," she said.
At a hearing in early July, she repeated industry talking points when asked if finding experts with no ties to industry was causing a “time lag” in drug approval.
Yes, it is true. It is also true we have difficulty recruiting qualified people and having highly qualified panels, and in some cases we've had to delay advisory committees because the difficulty of…because once we go through, in great detail, all the financials of the individuals we've nominated, we find that they have to be excused from participating.
So what? you might ask. Who cares what Dr. Woodcock thinks?
The problem is that Janet plays Rasputin to FDA Commissioner Margaret Hamburg, often bending the Commish’s ear to whisper ideas on how to run the agency. So it comes as no surprise that Dr. Hamburg has begun parroting the industry’s—er, Janet’s—talking points.
A couple of weeks ago, Dr. Hamburg said that “valid concerns” have been raised about conflicts of interest rules, prompting an agency review.
Not so fast. The facts, at this time, don’t support any rules “review.” If anything, this looks like a clever move by Dr. Woodcock to create a “problem” that exists not at the FDA, but in the boardrooms of Big Pharma.
Because Dr. Woodcock’s thinking has been wrongheaded and muddled for so many reasons, I’m going to defer to one of my favorite bloggers, Tim Lambert. He’s an Australian computer scientist who writes at ScienceBlogs.
When frustrated with a particularly intransigent individual, for whom facts and logic don’t seem to matter, he likes to hoist their arguments up on a rope, much like a piñata, and start whacking away with a “clue stick.”
Why a clue stick? Because when logic and facts fail, your only defense against the obtuse barbarians is to whack away at their reasoning until your arm grows tired. You may not change anything, dear reader, but the clue stick produces tasty nuggets of stupid.
Release Woodcock Piñata, Grab Your Clue Stick
The law allows FDA to grant waivers for conflicted experts who serve on advisory boards. The cap is set at 13 percent, yet the agency has never allowed more than 5 percent of a committee’s members to have a waiver.
Hmmmm... If there are still plenty of waivers to hand out, then why is Janet making such a big deal?
Good question. I don’t know. I think we're ready for the clue stick.
Second, FDA’s own data finds that the vacancy rate for advisory members continues to fall every year. That means FDA is getting better and better at locating outside experts for advice.
Gentle reader—are you wondering, Um, rules are always hard to follow at first, until you get the hang of it. So why is Janet making such a big deal…?
Again, I’m like you. Confused. Should we discuss further...or clue stick?
Third, a federally funded study of 2914 academics by Harvard University’s Eric Campbell finds that almost 50 percent of research academics have no ties to industry. That’s right, ZERO financial conflicts. Dr. Campbell published his data in the journal Health Affairs and discussed it last June at a Georgetown University conference.
Oh, approximately one third of these researchers are full professors.
Dancing through your head may be something like, Well, if all these experts are out there, why won’t FDA use them? I’m getting a little irritated.
Yep. I’m irritated too. You want the clue stick this time?
Fourth, a study in the Archives of Internal Medicine looked at participants who put together clinical care guidelines for cardiology. These guidelines help your personal cardiologist know how to treat you. Yet, the study found that 44 percent of the experts putting together the guidelines had no financial conflicts of interest. Again. ZERO!!!
Paul, I’m really...I’m somewhat...I’m beyond irritated now. Hand me the clue stick! Give it to me now!
Whoa. Calm down.
Fifth, while Janet and her staff at FDA can’t find qualified researchers without ties to industry, journalists Shannon Brownlee and Jeanne Lenzer had no problems. Three years ago they organized a list of 100 medical experts with no corporate ties and published it in the British Medical Journal.
Now, some of these experts probably would not qualify to serve on advisory boards, but many of them obviously could. So if two reporters on a freelance budget can assemble such a list, why can’t Janet?
Give me the stick!!! I’m going to make it rain golden buckets of stupid!!!
Glad that’s over . . . You really need to take it easy.
Piñata is supposed to be fun.
FYI, Shannon Brownlee and Jeanne Lenzer sent their own letter to Dr. Hamburg yesterday expressing “dismay” that the agency is attempting to loosen conflict of interest rules because they can’t find qualified experts. To help the agency get its act together, they attached a list of qualified experts.