(Updated)– There’s a widespread belief that only a conservative like Nixon could have opened up US relations with China. Any attempt by a Democrat to do the same would have been political suicide, but for Nixon it was politically feasible, and today it is recognized as one of his very few untarnished genuine achievements.
I want to suggest that Rob Califf as head of the FDA may– may!– represent a Nixon in China kind of moment.
Please understand that I do not mean to suggest that Rob Califf is similar to Richard Nixon in some of the negative ways a comparison like this might suggest. I’ve covered Rob Califf for nearly 30 years and though I’ve often wished he would return more of my phone calls or emails I’ve never thought he was ever anything less than honorable. Moreover, he’s just about always been the smartest guy in rooms that contain a large number of other smart guys. Even more important, to my mind, is his ability to see different sides of complex questions. Califf is deep, and he has a subtle and unsettling sense of humor and irony. After being around him I nearly always learn something important and worthwhile.
I’m not surprised that Public Citizen has called for the senate to reject Califf’s nomination. The consumer advocacy organization says that the “nomination undoubtedly comes as welcome news to the pharmaceutical and medical device manufacturers, but is bad news for patients and public health.”
“No FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed,” says Public Citizen. But I think Public Citizen is mistaken, though it is certainly true that Califf has worked closely with industry throughout his career. But if you’ve paid careful attention to his words it’s clear that Califf’s primary goal has never been to serve industry.
As a consummate insider, Califf knows all the tricks, and will not be easily manipulated. Califf is also a pragmatic guy. Don’t expect grand and dramatic but ultimately futile gestures. He is not interested in generating headlines for their own sake.
Most importantly, I don’t think Califf has worked all these years to simply deliver the FDA into the hands of industry.
A Key Moment In Califf’s Career
It may be instructive to go back to an early key moment in Califf’s career, the first GUSTO trial, which came out in 1993. It’s hard to appreciate today the drama and interest in the trial at that time. Today we’ve become used to mega-trials and the excitement of biotechnology. GUSTO was one of the first mega-trials and it involved the first major biotechnology product from one of the first biotechnology companies, Genentech. It was almost certainly the most expensive clinical trial performed to that date.
Califf had been a rising cardiology star for several years, leading, along with Eric Topol, a younger generation of cardiologists eager to help develop the revolutionary new developments of thrombolysis and interventional cardiology. The first GUSTO trial put Califf and Topol at the apex of this new generation and the newly revitalized field of cardiology.
GUSTO was also important because it established the precedent of independent investigators acting freely without interference from the sponsor. Led by Topol and Califf the GUSTO steering committee created a firewall between themselves and Genentech. It was very clear to everyone at the time that this was a major precedent, and that Topol and Califf had established a new standard for the conduct of clinical trials.
After it was over Califf could have cruised for years on the strength of GUSTO. He could have strengthened his ties with Genentech and performed more trials for the company. He could have made a very comfortable living giving talks on behalf of Genentech for the next several years.
Instead he did something unexpected and very smart. As far as I know Califf never worked with Genentech again after the first GUSTO trial. Instead he used the infrastructure from the GUSTO trial to create the Duke Clinical Research Institute (DCRI). In fact, the main reason this separate infrastructure existed was to ensure the independence of the trial. DCRI was created as an alternate and independent academic research organization separate from the purely commercial operations run by the pharmaceutical industry or outside companies.
Yes, the business model for DCRI has been largely based on performing clinical trials for industry. But Califf never allowed it to fall into the trap of representing a single company or a simplistic industry-friendly viewpoint. Instead, his one consistent mantra over the years has been his insistence on the supreme importance of well-conducted clinical trials.
I suppose you could say that over the years industry has “used” Califf. This is probably what Public Citizen has in mind. But it is at least equally true that Califf has “used” industry to promote the use of clinical trials and to raise the bar of conduct for clinical research. If I had to bet, I would guess that this would be the one main goal for Califf in his tenure at the FDA. It’s hard to imagine that he wants to run the FDA only in order to hand the keys of the kingdom over to industry. That’s never been the way he’s operated. But I think he is interested in finding ways to use the enormous resources of industry to develop new therapies.
Of course history and politics could get in the way of genuine achievement. One distinct possibility, in the wake of Caronia and Amarin, is that the power of the FDA may have been grossly undermined. It’s possible that the FDA will be reduced to the role of a kind of Chamber of Commerce for the pharmaceutical industry. That would be unfortunate but it wouldn’t be Califf’s fault. And I doubt it would be his choice.
Two additional thoughts:
First, it should be stated that, even after 20 year,s the GUSTO model of independent academic trials is still not a universal standard. Many large clinical trials are still designed, run and controlled by industry. So in many respects Califf’s GUSTO model is still ahead of its time. On the other hand, some critics believe that even this model is subject to abuse. Some savvy companies, it has been alleged, have learned to play the academic research organizations off against each other. Like just about everything else, AROs have an institutional imperative to survive. No one is perfect.
Second, I would dearly love to know Rob Califf’s stance on the open data movement promoted most notably by AllTrials.Net in the UK and the YODA project at Yale. (Here’s Califf’s slides from a talk he gave in 2012 on data sharing.)