Effect Measure

One of the most dismaying “features” (or is it a bug?) of the US government is the too cozy relationship of key agencies with industries they are either regulating, investigating or affecting in some ways. The revolving door syndrome perhaps reached its peak in the Bush II administration, but it’s been a chronic problem going back decades or longer. Yesterday we learned of another example when Big Pharma giant Merck & Company issued a press release announcing it had hired Dr. Julie Gerberding (often referred to by CDC employees simply as “JLG”), the first female Director of CDC (hat tip Daniel Cressey, Nature’s blog, The Great Beyond). She served George W. Bush through a tumultuous and controversial tenure from 2002 to its last day, Jan 21, 2009. Talk about hanging on to the last minute. Her job? Head of the vaccines Division:

Dr. Gerberding will lead the company’s $5 billion global vaccine business. Merck currently markets a broad range of pediatric, adolescent and adult vaccines and is a leading provider of vaccines in countries around the world; in the U.S., Merck markets vaccines for 12 of the 17 diseases for which the U.S. Advisory Committee for Immunization Practices currently recommends vaccines. She will be responsible for the commercialization of the current portfolio of vaccines, planning for the introduction of vaccines from the company’s robust vaccine pipeline, and accelerating Merck’s on-going efforts to broaden access to its vaccines in the developing world. Dr. Gerberding will also collaborate with leaders of Merck Manufacturing Division and Merck Research Laboratories to manage the critical linkages between basic research, late-stage development and manufacturing to expand Merck’s vaccine offerings throughout the world. (Merck Press Release)

We were critical of Gerberding through most of her CDC tenure (here, here or here or just put site:http://effectmeasure.blogspot.com gerberding into your Google search bar; there were so many posts about her I couldn’t possibly list them all). I always gave her high marks as a risk communicator, one of the best I’ve ever seen. Even I believed her. Her successor, Thomas Frieden, is a walking public communications disaster area: arrogant sounding, dismissive and a poor listener when it comes to what the press and public are asking. So Gerberding has him beat, hands down (although the Acting Director, Rich Besser, who presided over the opening months of the flu pandemic was superb, even better than Gerberding and Anne Schuchat is also excellent). The problem with Gerberding was that she didn’t speak cogently, persuasively or credibly to her paymasters in the Bush administration. She did two things, one unforgivable, one incompetent and destructive.

The unforgivable one was not to fight for public health publicly and with every tool at her disposal. I’m not privy to what she did to argue for public health at the highest levels of the administration (my suspicion she was more of a sycophant than and advocate), but publicly she was passive and and relatively uncomplaining in the face of official neglect or hostility to CDC’s mission, to protect the public health. But it was worse. The incompetent and destructive thing, as the many blog posts linked above indicate, was that she took a managerial wrecking ball to the place, bringing in management consultants, contractors and pushing hard on a major restructuring that threw the agency into dissarray and emptied it of its institutional memory as professional scientists headed for the exits. It got so bad that bevies of ex-CDC Directors were voicing concern publicly and privately, an extraordinary thing to have happen.

I’ve reviewed the literature on influenza vaccine and feel confident that it is a rational and effective public health measure. But I have long been disturbed at the dogmatic way CDC has pushed a seasonal vaccination campaign that targeted my age group (over 65) and refused to acknowledge the questions about reduced efficacy in the elderly. Here’s an example of one of our posts from over 2 years ago:

On the other hand, the data present a serious challenge to the CDC program which concentrates on blanket coverage of the 65 plus age group. Both epidemiological and biological data suggest that immune response declines with age. Us older folks just don’t respond as well to the vaccines. This in turn suggests that instead of blind faith in the current program, alternative ideas should be explored, including shifting the target to younger age groups responsible for transmitting the virus in the population. If indeed it is true that there is some cross-reactivity between subtypes, vaccinating younger age groups might have special importance prior to a pandemic.

The authors [of the paper being discussed in the post] also have other options:

Refocusing on the likely complications of immune senescence should help clear the way for more vigorous pursuit of other options for influenza control. These options include the development of more-immunogenic vaccines for elderly people, use of larger doses of vaccine, the combining of live and killed vaccine formulations, use of antivirals in a more aggressive manner for treatment and prophylaxis, and indirectly protecting elderly people through increased vaccination of transmitter populations. Implementation of any of these alternative approaches must be accompanied by valid assessments of their effectiveness. (Simonsen et al., The Lancet Infectious Diseases [subscription required]

These are good suggestions. I fear they will fall on deaf ears at CDC, however. Those folks are “true believers.” We all know what that means: blinders and ear plugs in place and full speed ahead. (Effect Measure, September 26, 2007)

Now we have the spectacle of the most recent CDC Director heading up Merck’s vaccines Division. Revolving door syndrome just at at time when we need confidence in the recommendations of CDC the most. History repeating itself. Good for JLG. Bad for public health.

Comments

  1. #1 Don S
    December 23, 2009

    Seven years in public policy position is a revolving door?

    She should not work any more because she was in public policy before? Or only take government jobs? Or maybe she just needs to stay out of working for industry in areas she has any expertise in?

    I really don’t get this.

  2. #2 revere
    December 23, 2009

    Don: I really don’t get this.

    Clearly. That’s why you think it’s about her specifically and not generically about the revolving door. It’s not that she has a job. It’s what her job is and how quickly after federal employment she assumed it. It’s like the Pharma – FDA connection. There are a lot of jobs out there that wouldn’t fuel suspicion and have an unseemly odor. Rich Besser going to ABC, for example, or other CDC Directors going to foundations or academia. But either you get it or you don’t.

  3. #3 Don S
    December 23, 2009

    Okaay. A little dismissive aren’t we? Honestly I am not being contrarian for its own sake (albeit taking the critical view of anything I read or hear is both what comes naturally and what has been trained into me). I thought the “revolving door” referred to people entering and leaving the public sector jobs quickly. You are instead referring to how quickly those who have been in the public sector get jobs in the private sector when they leave.

    Is the intimation that she did things in her public sector capacity in service of her future masters or to endear herself to them? Or that she has insider knowledge now that a private should not be privvy to?

    I’d have no problem with a stipulation to a contract at a certain level of public sector service that there be a predetermined period of time after leaving that the individual could not work for an industry that is directly influenced by the position that was just held (sort of like a restrictive covenant).

    But OTOH I have no problem with Merck’s vaccine division being headed by someone who knows enough about vaccines to have been in her previous position and who cares enough about the public good that she spent years in public service.

    In any case if it is going to the expectation that you cannot go work for a private after serving in the public sector (for at least some number of years) then it should be made part of the legally binding expectation before you sign up for the public sector job. I am not sure what effect that would end up having though.

  4. #4 revere
    December 23, 2009

    Don: Not dismissive but redirecting and you seem to have gone in that direction at the end. I gave examples of Directors who went into the private sector. The reason this is here is that we have raised the question of CDC’s cozy relationship with vaccine manufacturers many times (links were provided) so this isn’t jsut, hey, she took another job; and it isn’t just about JLG. I might say that to call it “dismissive” is also dismissive. I think it dismissed the interpretation you took but redirected it to where I meant it to be.

  5. #5 Mark P
    December 23, 2009

    The revolving door has never referred to how long a person has served in a government position, it has always referred to leaving government and going right to work for a company that you have either provided or managed a contract to, or have had regulatory control over. The problem is not that she went to work in private industry, it’s that she went to work for an industry over which her agency had regulatory control. In my opinion, this example is so blatant that she is thumbing her nose at the public she was supposed to be serving.

  6. #6 BostonERDoc
    December 23, 2009

    We call it selling out in medicine. Funny thing we all think about it and wish to some degree we had the same opportunity . Lets see, she is going from a salary of say $125-150K tops with many perks to a salary in the $350-500K range with even more perks. My medical school’s dean just announced he is moving over to Merck. I have no problems with this type of behavior or job switching. We all got kids, a mortgage and a retirement fund that went south and needs repleting. Reality is money is everything in our society–Good and Bad. I wish them well. Merck is a reputable company and has done far more good than bad for humanity. I do have a problem with outrageous cashing in like for example former president Clinton and VP Gore–both who have made over $110 million a piece since leaving office. Now that is the ethos of selling out. Future presidents should follow the lead of junior and senior Bush–low profile and doing good rather than hoarding business opportunity.

  7. #7 revere
    December 23, 2009

    BostonERDoc: Well, Bush I. was a rich Brahmin, connected like crazy, so his lower profile means nothing as far as I’m concerned. Clinton didn’t inherit money and made it selling his book to people who wanted to buy it, like any celebrity. Same with Obama and Palin. Even Herbert Hoover wrote his autobiography. I didn’t like Clinton but he’s done a tremendous amount of good with his Foundation in public health. Carter is probably the model, though. As for Bush II, the less we hear from him the better. Gore? I detested Gore for reasons unconnected with his VP-ship or climate change but I don’t begrudge him earning money honorably and legally. As doctors, you and I get paid a lot more than most people for no particularly good reason.

    As for the amount of good Merck has done it has to be balanced with the amount it could have done and some of the bad. To the extent they’ve done good by marketing drugs (others research them on the tax payer’s dime), they’ve done well by doing good. I know one of the former directors of Merck vaccines and he’s smart and I like him. But it’s an institutional issue and the institution isn’t a pearl of great value in my book.

  8. #8 walrus
    December 23, 2009

    Look up “Narcissistic Personality Disorder”.

    The actions Gerberding took at CDC bear the telltale marks of this disorder. I’ve seen it first hand in business.

    Ruthless centralisation, the removal of anyone seen as a barrier, especially competent subordinates, and their replacement with sycophants.

    I would not like to be a senior scientist with any profile working in Merck vaccines at the moment because they will be given the choice of becoming a sycophant or leaving.

  9. #9 BostonERDoc
    December 23, 2009

    Clinton made his money by charging outrageous fees to speak at coleges etc. His MO: want an ex president to speak at your college, foundation, etc? It will cost you –and dearly with price tag over $100K. God knows how much he made in the sand over in the middle east.

    I disagree with you Revere on your statement about doctors and money. I can only speak for myself on this: I grew up poor. No scholarships or special preferences. I worked 2 jobs in college and paid my tuition, room and board in full for college and medical school with no bank of dad. NIH grant paid my grad school. I still have student loans 18 years out of medical school. I give over $150K in free care a year with no tax break. My research has saved lives. I put up with tons of shit from whining patients, risk all my assets since the laws say doctors can be sued for all of their possessions unlike any other profession. I am physically and verbally attacked by pts on a regular basis when I am in the ER and I risk my health daily. Finally I work nights, holidays and weekends. So while you think you make too much money I think I don’t make enough.

  10. #10 revere
    December 23, 2009

    BostonERDoc: Clinton’s money is mainly book money but like any celebrity he commands high speaking fees. So what? As for you (and me), yes we work hard. Lots of people work hard. Even harder than we do and they also take a lot of crap. They do jobs (often several, if they are lucky enough to have one) that give them zero satisfaction and they have families to feed. The do things that we depend on, too, and save lives.You want to live with out phones or electricity or police or fire protection? Garbage collection? Running the sewage treatment plant? We should get free education and get paid like anyone else, IMO. My father was a doc and worked 7 days a week his entire career. Plus he made house calls (he died of an MI after coming back from one). He never made much money because no one had insurance and there was no Medicare. He liked what he did and that was a payment most people never get. Doctors are paid too much and so are celebrities and CEOs and a lot of other folks. And lots of people work hard — harder than we do.

    Anyone can be sued for negligence, not just doctors. And they are. And most damage from negligence is never compensated. If we had a NHS that indemnified us that would solve the problem.

  11. #11 BostonERDoc
    December 23, 2009

    Good grief Revere. Your sounding like a communist. What would Mrs. Revere think if you showed up home with a pay check of $1K a week?

  12. #12 revere
    December 23, 2009

    BostonDocER: Her father worked on a truck for the city gas utility. She knows what it’s like. And my daughter works in an Emergency Room for less than that and works very hard as a social worker. We’d make it and if that’s the way the world worked for everyone, we’d all be better off.

  13. #13 Davey O.
    December 23, 2009

    “Revere” opines:

    “The problem with Gerberding was that she didn’t speak cogently, persuasively or credibly to her paymasters in the Bush administration.”

    How could you possibly know this?

    Unlike you, I was on many a call and in numerous meetings with JLG and her “paymasters”.

    She was no sycophant.

    When you lapse into snarky ad hominem attacks you undermine your authority as one of the smarter guys on the block.

    Shame on you.

  14. #14 Davey O.
    December 23, 2009

    Mark P Sez:

    “The problem is not that she went to work in private industry, it’s that she went to work for an industry over which her agency had regulatory control.”

    Since when does CDC “regulate” the vaccine industry? Perhaps you need to learn the act/art of googling.

  15. #15 SusanC
    December 23, 2009

    Since when does CDC “regulate” the vaccine industry?

    Maybe not ‘regulate’ in the strictest sense of the word, but the ACIP within the CDC is responsible for making recommendations for use of vaccines that are already licensed. Here’s what the ACIP charter says:

    The committee shall specifically provide advice for the control of diseases for which a vaccine is licensed in the U.S.

    This has implications as follows.

    The big elephant in the room is Gardasil, 1 of only 2 products that brought home the bacon for Merck, to cover fall in sales of other products. However, such good fortune cannot last forever, as they run out of young girls whose parents are willing to let them get vaccinated voluntarily, and older women decline to take the bait, especially since the FDA also refuses to play ball on that one. They did, however, succeed in winning approval for use in boys, but the FDA also at the same time approved Cervarix, their biggest and only rival. So things are decidedly mixed, for this much touted money-spinner.

    (Whether there is any science behind the rationale for vaccinating many millions of young kids against cancers decades down the road for which the vaccine has demonstrated neither convincing protection nor cost-effectiveness, whether in developed or developing countries, is another story, especially since as far as I can tell none of the cost-effectiveness studies has factored in the cost of the considerable adverse effects.)

    Anyway, let’s look at the timing for some interesting events:

    1) Gardasil was first licensed by the FDA on June 8, 2006.

    2) Only 3 weeks later, on June 29, 2006, the ACIP recommended Gardasil for vaccination of all girls from aged 9 onwards, basically, to anyone not yet sexually active aged 26 or below.

    3) One might think this was a demonstration of CDC efficiency. But a closer look at the ACIP transcripts shows, even more astonishingly, that an ACIP working group had been making deliberations since February 2004, TWO WHOLE YEARS before any such vaccine was licensed!!

    The Advisory Committee on Immunization Practices (ACIP) HPV vaccine workgroup first met in February 2004 to begin reviewing data related to the quadrivalent HPV vaccine. The workgroup held monthly teleconferences and meetings three times a year to review published and unpublished data from the HPV vaccine clinical trials, including data on safety, immunogenicity, and efficacy.

    Well, one must admire the leadership of ACIP/CDC, for being able to obtain and deliberate on published and unpublished data on a vaccine long before licensure. Readers may recall the recent brouhaha about the inability of Cochrane researchers in obtaining data from Roche, TEN YEARS after tamiflu was licensed!!

    So, who knows, maybe Julie G does have some magic, after all, in facilitating such ‘partnership’ between industry and public health? Maybe that’s what the US taxpayers paid her for, although I suspect such virtues may be even more valued by her new employer….

    In the meantime, she has of course avoided having to deal with a recent HHS Office of Inspector General report that found almost 100% failure in CDC’s enforcement of conflicts of interest rules for ‘special government employees’ a euphemism for members of CDC advisory committees including the ACIP, (which btw was specifically named in the report):

    FINDINGS
    For almost all special Government employees, CDC did not ensure that financial disclosure forms were complete in 2007. CDC certified OGE Forms 450 with at least one omission in 2007 for 97 percent of SGEs. Most of the forms had more than one type of omission.

    So, no, the CDC does not ‘regulate’ the vaccine industry in the way that the FDA is supposed to do (THAT, of course, is a whole different story), but it and its less-than-properly-scrutinized advisory committee(s) are/were in charge of recommendations that drive choice, usage, and public funding of such vaccines, which in the case of Gardasil has by now reached billions of dollars.

    If this is not a case of ‘revolving door’ kind of conflict of interest, I don’t know what is…

  16. #16 Paula
    December 23, 2009

    Re Revere’s 2007 comment on the CDC, “Those folks are ‘true believers.’ We all know what that means: blinders and ear plugs in place and full speed ahead”: It has seemed to me this has been true re 2009h1n1 vaccine recommendations at times. And definitely it is true among government officials (county, state, probably national) re public health effects from wind turbine noise; I’ve been crash-researching this field since a WT site has been proposed a mile away, and it appears public officials, certainly in my own state and county, but apparently in many and in parts of the UK, Australia, Denmark, etc., have simply latched onto studies (often industry sponsored) “showing” such health effects to be mere “annoyance,” “psychological not physiological,” “only in unusually sensitive” persons, or etc.–with doctors and studies showing the health effects to be real then being dismissed also. It seems a wider-spread “Oh you Love Canal kooks with your nonsense complaints” reaction by proponents–who unfortunately claim to want environmental health and “clean” energy while installing, after pushing past or overrriding community input, such turbines, which often have been built by such great antipollution enterprises as GE. Any thoughts on this public health menace and the revolving industry-government door in the early 21st century?

  17. #17 Erica Andersen
    December 23, 2009

    No one is forced to pay Clinton huge fees for having him speak, for heaven’s sake. He charges what these organizations are willing to pay.

  18. #18 NP
    December 25, 2009

    Unless she got a job offer from Merck while still in office, I’m not too sure what the actual problem here is other than one of appearances. There appears to be a conflict of interest, but then one would have to assume that she already knew of her future appointment with Merck while serving as the CDC chief.

  19. #19 revere
    December 25, 2009

    NP: I think there are two distinct probems here. One is perception that CDC is too close to the vaccine industry. That’s a problem for CDC and for public health insofar as it affects the credibility and cogency of CDC recommendations for vaccinations (recommendations, for the record, I agree with). The second is the substance of the revolving door problem, which is that people in the private sector who have access, know the ropes on the inside and know how the sausage is made gain an advantage over competitors and over the scientific process.

  20. #20 Alexandra Witze, Nature
    December 28, 2009

    I hate to nitpick such a fabulous blog, but your hat tip above to Daniel Cressey properly links to Nature’s The Great Beyond blog for which he works, not our deadly rival published by Science. :)

  21. #21 revere
    December 28, 2009

    Alexandra: Oh, my. The perils of being old and tired. My apologies. Fixed.

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