Monday, February 2, 2009

FDA Candidates, Through The Carlat Lens

According to Reuters, President Obama will be naming his choice for FDA Commissioner within “days.” Most sources say that he has narrowed his choices down to the following four candidates: Joshua Sharfstein, head of Baltimore's health department; Robert Califf, cardiologist at Duke University; Cleveland Clinic cardiologist Steve Nissen; and Susan Wood, former head of the FDA's Office of Women's Health. However, the rumor mill seemingly churns hourly--now, according to Drug Wonks, former New York City Health Commissioner Margaret Hamburg is also in the running (Hamburg's name surfaced too late for me to give her a mini-review).

I’m not sure who I would pick. I personally know Dr. Steve Nissen and think he would be an fantastic choice, because he amply understands the challenges and imperfections of the FDA and has clear plans for fixing the agency. And, of course, it doesn’t hurt that he has never been afraid to call out drug companies for hiding inconvenient data about drug side effects. Dr. Nissen, if you’ll recall, was the one who broke the Avandia story
. But he is hardly anti-pharmaceuticals. As chair of cardiovascular medicine of the Cleveland Clinic, he has conducted industry-funded research, and he has focused on using intravascular ultrasound (IVUS) imaging for treating coronary atherosclerosis. His disclosures are listed here, but note that he receives no personal income from these relationships, insisting that companies donate all honoraria to charity.

Susan Wood is another great choice. A heroine when it comes to women’s rights, Wood was the FDA’s Director of the Office of Women's Health until 2005, when she resigned on principle over the delay in approving “Plan B,” an emergency over–the–counter contraception (not to be confused with the “abortion pill,” RU-486). She is currently a professor in the School of Public Health at GW University. You can read up on her here
and here. As far as I know, she has no financial relationships with any pharmaceutical company, and she is the only candidate who is not an M.D., for better or for worse.

Josh Sharfstein, who is currently head of the Baltimore Health Department, has an interesting psychiatric connection in that his father, Steve Sharfstein, is the former president of the American Psychiatric Association. Steve Sharfstein made a splash by publishing this column
in which he urged clearer boundaries between physicians and industry enticements. Josh Sharfstein has an equally strong sense of ethics, and has in the past called Pfizer onto the carpet for improper promotion (he once alerted the New England Journal of Medicine that Pfizer was inviting docs to a “rack ‘em up and toss ‘em down” event including billiards and lots of alcohol). He has also worked on the staff of Representative Henry Waxman, who is now chair of the powerful House Energy and Commerce Committee. Sources tell me that he has no financial relationships with the pharmaceutical industry.

The only truly bizarre entry on Obama’s short list is Dr. Robert Califf, vice chancellor for clinical research and professor in the cardiology department at Duke. I have no problem with his experience and extraordinary academic achievements. And I hesitate to criticize a fellow grad of UCSF Medical School. But c’mon folks, look at these industry disclosures. He took money—lots of money--from 18 different pharmaceutical or device firms. Most of this was not for research, but for consulting and speaking, including CME. If Dr. Califf believes that it is ethical for physicians to help drug companies market their products, that’s his own business. But to elevate him to a position in which he is the country’s chief watchdog over unsafe medications and foods seems a dangerous move. With money from 18 drug companies padding his bank account, he will presumably spend most of his FDA career recusing himself from crucial decisions. Not a good idea.

So, Mr. President, in my opinion you can’t go wrong with Nissen, Wood, or Sharfstein—but please keep Dr. Califf out of the running.


Anonymous said...

I believe you mean well with this posting, and I have followed some of Dr J Sharfstein's career in Baltimore so I would support his appointment over the others as a biased comment, but, that said, at the end of the day it is not who is chosen to run a department or program as much as who is still in place who would sabatoge even the best of efforts by a leader.

And, since you bring politics into the blog again, let's be direct here and realize that Obama is a politician at the end of the day and still surrounds himself with entrenched politicians who look out for themselves first by example. Now we read of Daschle engaging in poor decisions with tax declarations?

We can only hope someone of true caring and investment in the process he/she is asked to lead will do so by example and integrity. Every appointment that has muck only diminishes those who are clean.

Just an opinion.

Anonymous said...

After writing the above post, I came across this little gem, so hope interested readers will read it:

It's about Tom Daschle and why he is not the exemplary choice every one outside Obama's circle is quick to note. So, to relate it back to this post, will Obama choose who is right or who is convenient? I bet on the latter!

Anonymous said...

are you out of your mind re Nissen? I'm glad you like him (not sure that's important, though), but look at what he has said about stimulant medications, which reflects the common and tragic belief that, since psychiatric illnesses are not 'real', there's no such thing as risk/benefit. Nissen??? really??? Read what he writes about psychiatry.

For what it's worth, Sharfstein is brilliant, committed to public health, and lacking in the showmanship and self-promotion (and antipsychiatry bent) of Nissen.

Supremacy Claus said...

Dan: You are obsessed. You disqualify a person for relationship with a drug company.

I am obsessed too. I disqualify these left wing extremists as a threat to clinical care.

wetnurse said...

Here's the view through my lens:
Replacing the head of the FDA is meaningless if the rest of the offenders are allowed to stay.

Every single scientist at the FDA has to go.

Every. Single. One.

Unless it's possible to prove that any of them do not now or have never allied with Pharma against the common good. Which I have to doubt.

Everyone from the top down, adios!

Okay. Maybe we can keep some of the people who answer the phone, and the guy that works in the mail room.

The only way this agency can regain the public's trust is make itself worthy.

Maybe they can all get jobs working for whatever pharmaceutical company's interests they allowed to trump the public's safety.

Anonymous said...

Fair enough. But do you also disqualify those right wing extremists who are a threat to public health?

Supremacy Claus said...

Anon: I seek the personal destruction of all oppressive, officious intermeddlers in clinical decision making between patient and doctor.

Roe v Wade supports that view. It is usually seen as a Fourth Amendment, privacy decision. A clinical decision offended a state law. The state law got struck down. It is an officious intermeddler deterrence decision.

Anonymous said...

Hey SC:
Just what do you mean by seeking the “personal destruction” of “intermeddlers?” I mean death? Tar and feathering? Crucifixion? Suicide? Self-implosion by any means? Oh, and what about the FDA? We should abort that agency as well? Deregulation for all? Pop any pill or substance, including snake oil, no matter where it came from (hopefully not China!), just because some patient might find a doctor who claims that you will live forever? Are you serious? I have often regarded your posts as somewhat… I am searching for a word here … ah, yes “obtuse.” But this is over the top!

Anonymous said...

To anonymous:

SC is the blog equivalent of the Joker character in Dark Knight.

he lives for anarchy and arguments.

Now, back to this post, Rose seems to echo my sentiment that if the "not ready for prime time players" under the director are still in place, nothing of significance will be done, irregardless of who is FDA chief.

And, at the end of the day, if you are a grounded, realistic citizen, who is really running the show at the White House? You really believe it is Obama? Note the strings behind him at the next public appearance. Would any realistic person appoint the chief opponent in the primaries as Secretary of State?

New party, same old fecal material!

Anonymous said...

The characterization of Califf seems pretty unfair.

The link to his disclosures is broken. Here it is:

The majority of the checked boxes are under (3): "All consulting income is donated to non-profit organizations, with the majority going to the clinical
research fellowship fund of the Duke Clinical Research Institute," and are less than $10k.

I think he's very much on the unconflicted end of the spectrum as prominent doctors go. A key opinion leader who truly wants to get involved and profit from a company's success will rack up $50k in consulting fees for five phone calls. This is not what his disclosure looks like.

And someone who is completely cut off from industry risks getting stuck in thinking and research that is irrelevant to the real world.

Daniel Carlat said...

Anon, You certainly have a point. Dr. Califf works with industry primarily with a scientific mission, rather than a personal profit motive.
The real issue is: what overall philosophy and attitude do we need in the next FDA chief? I suggest you look at this very collegial debate between Dr. Califf and Dr. Nissen on Medscape ( You will see two extremely intelligent and devoted physicians who view the drug industry in very different ways. Nissen sees a consistent pattern of companies putting profits ahead of the public health, while Califf sees the drug industry as being essentially an honorable business in which companies are struggling to do the best they can given a variety of financial and regulatory challenges. Personally, after seeing the effects of naked greed played out in company after company over the past two decades, I would prefer someone like Nissen in charge.

Supremacy Claus said...

TF: If I am such a joke, try rebutting me with a simple fact or logical argument, for a change, instead of personal insults. Those are OK when directed at the dissenters. They get censored if made by dissenters. There is evidence that supports the left wing hate speech. You are throwing a tantrum, and do not want to move from the psychiatry of the 1970's.

Anon: Those are tempting remedies, but they are too good for the left wing ideologues. No, they need to be countersued, and subjected to total e-discovery. They need to spend 1000 hours a year for seven years to defend themselves. They need to answer a monthly licensing complaint.

Let's say, you spend $10K on a totally frivolous countersuit. It has no merit in law nor in fact. It gets tossed out, with a stern warning from the judge. To get dismissed would cost the government or other institution up to $1 million. That sum would exceed the value of the meddler to the government, and he would be fired after a face saving interval.

If not dismissed one would demand total discovery on the records of the lawyer for improper motive, of the expert for lies, and for use in complaints to the licensing board. There should be an infinite number of rules broken by everyone on earth. I call lawyer gotcha a form of bad faith, however, if they use it, use it on them. To deter.

Anonymous said...

I agree with the very balanced view of Dr. Califf. He is a leading scientist, who has devoted his career to developing new treatments, and improving quality of care in cardiovascular medicine and beyond. He donates and funds to charity and for research.

More importantly though, he is a lead reformer in this area of setting up standards for relationships of academics and indusctry. He has helped establish some of the clearest rules on disclosures and conflicts of interest at Duke and DCRI, as lauded in an article in last week's New England Journal of Medicine.

Thus, Rob Califf would be a real reformer - that brings science front and center to the FDA mission, and establishes high standards for excellence in research.