Brenda Fitzgerald: Trump’s public health chief wants to partner with industry

BMJ 2017;358:j4233 doi: 10.1136/bmj.j4233 (Published 2017 September 13)                                                                              Page 1 of 2

FEATURE

Brenda Fitzgerald: Trump’s public health chief wants to partner with industry

The new head of the US Centers for Disease Control and Prevention has received praise for obstetrics campaigns, writes Jeanne Lenzer, but criticism for supporting quackery and using Coca-Cola’s money to fund anti-obesity programmes

Jeanne Lenzer associate editor, The BMJ, USA

When President Donald Trump named Brenda Fitzgerald as the new director of the US Centers for Disease Control and Prevention in June, several public health officials praised his choice to lead the seminal public health institute.

Georges Benjamin, executive director of the American Public Health Association, commended Fitzgerald, saying she is a “strong choice” to lead the apex public health agency. His statement read, “From her work as a practising

obstetrician-gynecologist to her recent service as the commissioner of the Georgia Department of Public Health, Dr Fitzgerald is more than prepared to face the health challenges of our time.”

scientific rigour and ensuring institutional independence from industry—Fitzgerald may not be such a surprising choice.

Bad science

Fitzgerald is a fellow of the American Academy of Anti-Aging Medicine (A4M), an organisation that promotes homeopathy, unproved stem cell therapies, plastic surgery, “bio-identical” hormones, and testing saliva and blood to “individualize” therapy with supplements and hormones to stave off ageing.

On her professional website, Fitzgerald informed patients that she had special training in the use of “bio-identical” hormones and supplements to treat problems such as osteoporosis, “middle

3 4

Others praised her position on abortion because she has said that the choice should be between a woman and her doctor—although she also has favoured restrictions on government payments for abortions.

As health commissioner of Georgia from 2011 to 2017,

age spread,” sex hormone problems, and general ageing.

Steven Goldstein, a professor of obstetrics and gynaecology at the New York University School of Medicine, told Forbes’s reporter Rita Rubin that he was “shocked” by Fitzgerald’s affiliation with the A4M, calling anti-ageing treatments “snake

5

Fitzgerald helped to reduce the high proportion of elective deliveries that took place before 39 weeks’ gestation in the state. She launched a campaign to inform healthcare providers that early elective deliveries led to “an increase in neonatal intensive care admissions, increased antibiotic use, and increased respirator use.” Her campaign led to a drop in early deliveries from 65% of elective deliveries to just 3%, and after a new Medicaid exclusion to pay for early deliveries, the rate fell further to 1%.1

Fitzgerald says that she practises what she preaches, “I typically hit the ground running by 6 am. I start with 30 minutes on the treadmill or around my neighborhood. A little sun salutation yoga and then I’m ready for breakfast—and I love breakfast. A pot of green tea and scrambled eggs with salsa and a slice of avocado are among my favorites.”2

She might seem to be an unlikely pick for Trump, who relishes fast food; has said that women who have abortions should face punishment; and whose budget plan includes a 17% cut in funding for the CDC.

But a closer look at Fitzgerald suggests that when it comes to two of the most important tasks of the agency—ensuring

oil” that “plays on people’s worst fears about their mortality.”

In response to a query from The BMJ about scientific rigour at the CDC, Fitzgerald said, “As director of CDC, I am committed to both science based decisions and [as] a former health commissioner, I also understand the importance of supporting states and clinicians, who are on the frontlines protecting the health of communities and treating patients, and making sure they have the state-of-the-art health information they need.”

But, Vikas Saini, president of the Lown Institute in Brookline, Massachusetts, told The BMJ that Fitzgerald’s embrace of unproved remedies “raises the risk that one of the world’s leading public health institutions may embrace the growing trend to permit anecdotes and observational data into regulatory decisions, instead of being a steadfast champion of rigorous science.”

Under the influence

The CDC has been under fire for accepting industry funding, including from Coca-Cola.6 7 (The agency began “winding down” its ties to Coca-Cola around 2013.) As health commissioner of Georgia, Fitzgerald was criticised after she accepted $1m (£760

jlenzer@bmj.com

BMJ 2017;358:j4233 doi: 10.1136/bmj.j4233 (Published 2017 September 13)                                                                              Page 2 of 2

000; €840 000) from Coca-Cola to fund a programme to reduce childhood obesity that focused on exercise to control weight gain without mentioning the role of fizzy drinks in the child obesity epidemic. Despite earlier criticism, Fitzgerald has declined to say whether she will reject future funding from the drinks giant, telling the New York Times that she would consider any proposals through the agency’s standard review process.7

Besides Coca-Cola, the CDC is funded by several drug and device manufacturers,8 a practice Fitzgerald defended in her statement to The BMJ, saying, “Public-private partnerships can be powerful tools that help extend government’s ability to save lives, solve problems, and speed innovation.”

Saini says that Fitzgerald’s work on reducing elective induction of labour is “important and laudable,” but he is worried that her willingness to partner the CDC with industry comprises a clear conflict of private interests with the public interest. This, he says “will continue to reduce trust in our institutions at a time when we need it more than ever.”

Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

Provenance and peer review: Commissioned; not externally peer reviewed..

1     Fitzgerald B. Improving care for women and infants in Georgia. Georgia Fiscal Management Conference 2014. http://georgiafmc.org/annual%20conference/2014/2014Presentations/ DPHImprovingCare.pdf.

2     Member Spotlight. Brenda Fitzgerald. 2017. http://www.astho.org/StatePublicHealth/ Member-Spotlight-Brenda-Fitzgerald/2-23-17/.

3     Dr Brenda Fitzgerald FAQs. Internet archive. 2010. https://web.archive.org/web/ 20100823214125/http://www.drbfitz.com:80/index.php?pid=23

4     Levitz E. Trump’s CDC pick peddled ‘anti-aging’ medicine to her gynecologic patients.

New York Magazine 2017 Jul. http://nymag.com/daily/intelligencer/2017/07/trumps-cdc- pick-peddled-anti-aging-medicine-to-patients.html

5     Rubin R. New CDC head Fitzgerald peddled controversial “anti-aging medicine” before

leaving private practice. 2017. https://www.forbes.com/sites/ritarubin/2017/07/09/new- cdc-head-fitzgerald-peddled-controversial-anti-aging-medicine-before-leaving-private- practice/.https://www.forbes.com/sites/ritarubin/2017/07/09/new-cdc-head-fitzgerald- peddled-controversial-anti-aging-medicine-before-leaving-private-practice/

6     Waters R. Trump's pick to head CDC partnered with Coke, boosting agency's longstanding ties to soda giant. Forbes 2017 Jul 10. https://www.forbes.com/sites/robwaters/2017/07/ 10/trumps-pick-to-head-cdc-partnered-with-coke-boosting-agencys-longstanding-ties-to- soda-giant/.https://www.forbes.com/sites/robwaters/2017/07/10/trumps-pick-to-head-cdc- partnered-with-coke-boosting-agencys-longstanding-ties-to-soda-giant/.

7     Kaplan S. New CDC chief saw Coca-Cola as ally in obesity fight. New York Times 2017 Jul  22.  https://www.nytimes.com/2017/07/22/health/brenda-fitzgerald-cdc-coke.html.

8     Lenzer J. Centers for Disease Control and Prevention: protecting the private good?BMJ 2015;358:h2362. doi:10.1136/bmj.h2362 pmid:25979454.

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The desirability of zero tolerance for procrastination - The Chris Selby-Smith Oration 2017

I chose the desirability of zero tolerance for procrastination for my remarks today because I have seen so many opportunities lost in health and medicine because of delays in taking action. Procrastination ranks alongside shortage of cash as an explanation of things not being done. It is, quintessentially, bad management.

Procrastination, according to Wikipedia, is “the avoidance of doing a task that needs to be accomplished. It is the practice of doing more pleasurable things in place of less pleasurable ones, or carrying out less urgent tasks instead of more urgent ones, thus putting off impending tasks to a later time”. Instead of discussing an impending financial crisis, the board of a corporation discusses parking arrangements for its members.

The word starts with pro meaning forward and ends with crastinate that comes from the Latin for ‘tomorrow’ – pushing things forward from today into tomorrow. The word dates from 1540, coincidentally around the time of the invention of the wristwatch. Any word enduring since the sixteenth century must have preserved its usefulness; otherwise it would have disappeared.

Procrastination is the subject of jokes:

• ·         "One of these days I'm going to get help for my procrastination problem."
• ·         "I like work. It fascinates me. I can sit and look at it for hours."
• ·         "The worst form of procrastination is reading a procrastination quote, feeling the guilt and not doing anything about it."
• ·         Or this superb quote from Homer Simpson "If something's hard to do, then what's the point?!"

There are several pages of citations of odes to procrastination on Google, most written by students, and most terrible.

But that procrastination is, indeed, a problem is reflected in the shelves of self-help books, supportive psychotherapy, invitations to join Procrastinators Anonymous and gurus who will free you of its grip – fee-for-service. You pay today, they free you tomorrow – perhaps. Even saints suffer from procrastination or from a variant. Saint Paul writes, in his letter to Roman Christians, “the good that I would I do not: but the evil which I would not, that I do.” Paul is identifying a deeper problem than that found in the common-or-garden variety of procrastination, but there are common elements.

Chris Selby Smith was the embodiment of non-procrastination. He had heaps of energy and promptly did what obviously needed doing. I knew him slightly between 1980 and 1984, after he became First Assistant Secretary in the Commonwealth Department of Health. He had a reputation that will surprise none of you who knew him – for a rare combination of brilliance, experience, good sense, warmth, humour and energy. My interactions with him over matters of research and research policy were a pleasure.

He would have approved of a recent BMJ editorial by John Potter, professor of epidemiology in NZ. John wrote about the accumulating evidence that eating red meat is bad for your health. (BMJ 2017;357:j2190 doi: 10.1136/bmj.j2190 (Published 9 May 2017):

‘The research community collectively understands the problem—overconsumption of meat is bad for our health and for the health of our planet; research even provides clear underpinnings for evidence based policy that could limit harm to both, but these underpinnings are not linked to action. As with many contemporary problems of resource overuse and misdistribution, we need to decide whether to act now to reduce human meat consumption or wait until the decay of sufficient parts of the global system tip us into much poorer planetary, societal, and human health.’

The editor of the BMJ, Fiona Godlee, recognised the problem and suggested one way forward BMJ 2017;357:j2190 doi: 10.1136/bmj.j2190 (Published 9 May 2017) – readers of the journal should change their own behaviours and reduce their consumption of red meat, she suggests, basing her recommendation of the history of UK doctors’ reducing their smoking on the basis of the evidence, in the mid-1950s, of its injurious effects. This contributed to the action on tobacco taken eventually in the UK, the US, Canada and Australia.

But you would have to acknowledge that it took a long time! Even now, 2,000,000 Australians smoke. It is unlikely that they do not know the hazards. Many wish to quit. Helpful quit strategies, together with taxation, advertising bans and changing social attitudes have reduced smoking to about 14% of our population. But many put it off.

When I was a respiratory physician, one of my saddest tasks was telling a patient that he (generally) had lung cancer. Procrastination kills.

I do not wish to posit, because procrastination is a health hazard, that the answer lies in rushing into decisions. That is not my intention. Indeed Amartya Sen, a Nobel Prize-winning economist, who is also a magnificent social philosopher, has observed that one of the biggest traps in developing policy is to skimp on time that should be spent on thought experiments designed to anticipate unintended side-effects. We should always ask “What will spin off from this new policy proposal?” Fools rush in.

I spent 1968 working in a small mission hospital in the western highlands of PNG – at Baiyer River. I was a ‘can do’ man – and there was a lot to do. After six weeks, the pharmacist, a local man named Trangipu, presented me with a ten-page order for our three-month supply of pharmaceuticals to come by Cessna 180 from Port Moresby.

I flicked through the list, removing several items for which I could see no need, including many litres of chloroxylenol. I had no idea what this was – so put the red pen through it.

When Trangipu was checking the delivery, he asked, in some distress, where the Dettol was. You guessed it. Dettol is choloroxylenol. I can’t remember how he overcame my error, but he was a phlegmatic, practical man used to dealing with stuff-ups.

Months later, when a chicken-pox epidemic was raging, I noticed that the patients no longer had pink patches from the anti-itch calamine lotion. The patches had turned white, stark against the dark skin of the Enga people. Having run out of calamine lotion, Trangipu had substituted the antidiarrheal medicine, Kaomagma, which seemed to be working just as well.

Not all rash and impetuous decision-making has such innocent endings. Take the decision to pay Medicare rebates for psychologists to work in association with general practitioners. When first suggested, I thought that this made great sense. But neither I, nor anyone else, expected the exodus of psychologists from the public hospitals and community health services – especially rural and regional health services – as they migrated to city general practices. I also doubt that the cost of these private services was accurately estimated.

So, in formulating policy, we need to steer between taking way too long and deferring action because, in Homer Simpson’s words, “it’s too hard, so what’s the point?” and rushing in, because of a sense of time, urgency, omnipotence or in the case of the Dettol, youthful hubris.

It is by no means easy to accurately identify procrastination, because other things can delay action and they are quite possibly culpable. The registration of medical practitioners is a complex task and, at its best, is a sensitive and thoughtful process. But here again procrastination causes problems, as when action is delayed in resolving what to do with an impaired practitioner. After the failure of the agencies of medical and criminal investigation to tackle complaints about sometimes fatal ‘Deep Sleep’ therapy at Chelmsford Hospital, a series of articles in the early 1980s in the Sydney Morning Herald and television coverage on 60 Minutes exposed the abuses at the hospital, including 24 deaths from the treatment. That forced the authorities to take action.

Let’s consider our obligations as managers, clinicians and citizens in handling procrastination in the health care system.

First, there is no harm in self-reflection. “The unexamined life is not worth living” is a dictum attributed to Socrates at his trial for impiety and corrupting youth, for which he was subsequently sentenced to death, as described in Plato's Apology. So, to avoid Socrates’s fate, we should check ourselves out, or, at the very least, ask colleagues whether they perceive us as unaware procrastinators. They might, if so, suggest how to get help.

Second, it is worth considering procrastination when, after things have gone wrong, we undertake root-cause analyses. It is easy to be transfixed by technical, structural and personality factors, as I have seen many times in clinical quality reviews. We readily miss the simple realisation that, if action had been taken ten, twenty or even sixty minutes earlier, the patient would not have died. How and why was there this unacceptable delay?

Third, we need to keep in mind Nobelist Daniel Kahneman’s explanation of much mistaken behaviour. We tend to substitute simpler questions for the difficult ones we are trying to answer or solve. Such ‘fast thinking’ satisfies the urgent need for a response, but is usually wrong, leading us down the wrong path.

Fourth, and this, in my view, is most important in eradicating procrastination – we should, as organised groups of professionals, discuss where, in the contemporary health-care environment, we appear to have paused, when we should, instead, be up and at it. As John Ralston Saul, a Canadian social philosopher, writes, there is nothing that beats the apparently inefficient process of discussion and debate in achieving progress.

To take one powerful example, our lack of engagement with the sectors which determine the health of our populations can be explained partly by ignorance about what should be done and partly because the task is large and outside our professional comfort zone. We procrastinate and find something less critical to occupy us. But consider this – if you reflected on the life expectancy of the locals as you drove from the Hills District in western Sydney to Mt Druitt, you would appreciate that it decreases by one year for every kilometre. This analogy, developed by Michael Marmot, draws our attention to the importance of the social determinants on health.

The World Health Organisation speaks of four dimensions of these determinants – economic, political, educational, and cultural – each enough to make us anxious. But Marmot has proposed how we health professionals could contribute evidence-based to help. To cite one example, he writes about progress in Brazil. 

Brazil has made spectacular progress in recent years in reducing social inequality and, of course, the associated unfair variations in health status. Enlightened leadership by President Lula brought about the Bolsa Familia conditional cash transfer system. Jonathan Tepperman, managing editor of Foreign Affairs has praised this arrangement: “Bolsa Familia was revolutionary in that it gave the poor cash. Now that had been a very controversial idea both in Brazil and the international development community for many years before that because the assumption was that if you gave the poor money, they would squander it on booze and cigarettes and cheap baubles and things like that.

“Lula who had grown up poor and was very proud of his heritage thought that was ridiculous and was very attracted to the idea that maybe it would work well if you gave money to the poor directly. And in fact, multiple studies have since borne out that such programs do work very well because it turns out the best people to know what the poor need are the poor.”

The lesson to be learned from Lula is ‘if you feel like procrastinating, think laterally.’  In that way, an array of solutions might emerge as from nowhere, presenting themselves for trial.

I do not wish to ascribe imaginary words or ideas to our late hero.  But from what I know of him, directly and through others, Chris Selby-Smith was a man of energy and vision.  He was active and not a person to sit back. He did not live to grow old. We need to take our lead from him in promptly applying our best energies to the improvement of the health of the nation. There is not a moment to lose. 

Sydney Ideas, Westmead - Scientific fraud and truth

Scientific fraud carries heavy moral freight. In 2001, the former editor of the BMJ, Stephen Lock, and his colleague Frank Wells ventilated about medical fraud in their book Fraud and Misconduct in Biomedical Research. They wrote that it is uncommon, and only temporarily misleading, because sources of medical information can be scrutinised. Fraud is thus eventually revealed and the perpetrator’s career destroyed.

But if fraud is uncommon, why do Richard Horton, editor of The Lancet, and John Ioannidis, an eminent epidemiologist, claim that half of all published research is erroneous?

I suggest that some unintended distortions may be responsible.

The ‘publish or perish’ adage places great pressure on academics, especially juniors. The number of publications, and not necessarily their quality, is often used for career advancement.

Horton explains in a Lancet comment that “in their quest for telling a compelling story, scientists too often sculpt data to fit their preferred theory of the world.”

Richard Harris’s book, Rigor mortis: how sloppy science creates worthless cures, crushes hope, and wastes billions, records that America spends 30 billion US dollars annually on biomedical research. Much, with hastily devised, poor design, improper methods and/or sloppy statistics, is wrong. Harris gives an example of 900 publications on a cell which was thought to be a breast cancer cell; it was not.

Editors, reluctant to publish negative outcomes, favour positive papers, attracting readers who cite them, and elevating the journal’s status. Erick Turner and colleagues published an article about this in the New England Journal of Medicine in 2008. They pointed out that, of 38 FDA-registered trials of a new antidepressant “viewed by the FDA as having positive results”, 37 were published. Of the 36 trials with negative results, 22 weren’t published, and 11 were published in a way that ‘conveyed a positive outcome’.

In Umberto Eco’s novel Foucault’s Pendulum a young monk expresses dismay that an older monk has not revealed the entire truth about a contentious matter. The older replies, “My son, think of it this way, that we have simply drawn a veil across the truth – to grant it respite.” Publishing only positive trials draws a veil over the truth.

Revelations about bias have a profound impact. In a recent BMJ article, the authors quoted results from a survey of a group of citizens and a group of GPs. Both groups were asked if they believed the results of new drug trials. Most participants in both groups did not believe them, more so the GPs, and the GPs were especially hostile towards pharmaceutical company-sponsored trials. With this low level of confidence, why would anyone participate in trials?

The fact that so many people are turning to unproven alternative and complementary medicines, rather than trusting ‘evidence-based Science’, reflects the cumulative effect of several factors. These factors include small manipulations, perceived investigator bias and the influence of pharma-sponsored dinners and travel, rather than distrust of research because of fraud. Ray Moynihan, in a Sydney Morning Herald article last week, drew from a recent BMJ article by Lisa Bero, Alice Fabbri, Moynihan and colleagues, and wrote about the extent of pharmaceutical sponsorship underpinning continuing professional education and the CPD requirements. A Fairfax investigation with Medicines Australia revealed that from October 2011 to September 2015, Westmead Hospital held 1,858 such events, costing $630,000. .http://www.smh.com.au/national/health/royal-north-shore-hospital-tops-list-of-sydney-hospitals-hosting-drug-company-events-20170706-gx68lq.html .

Fraud, unless ‘beaten up’ by the media as was the MMR vaccination furore, is of less public consequence.

Scientists often over-promise and speak in certainties. Good science is sceptical, and scientific truth only provisional. For example, anthropogenic global warming is a provisional statement from scientists who, if they are true to the sceptical nature of Science, should agree that they might be wrong. But when fashion dominates thinking can be an uphill battle to change attitudes. For example, when it was accepted that peptic ulcer was due to stress, it was difficult for Nobel Prize winners Barry Marshall and Robin Warren to ‘shift the paradigm’ by showing that infection was the causative factor.

Research, as former University of Sydney philosopher Ron Johnstone said, is the competitive generation and dissemination of new knowledge. There are no second prizes. Competition is intense – for grants, being first to publish and to accumulate a curriculum vitae in support of career advancement. Such competition tests weak spots in our ethical armour, with fraud eventually shaming the perpetrators and damaging the reputation of their institutions and their colleagues. 

But Science is, at its base, ethical. We must be alert to ethical challenges and take preventive action. Facts depend on honesty, not popularity. While we must respect prevailing ideologies and societal concerns, we should not be seduced, beguiled or misled. We must remain sceptical, and, as the great Nobelist Sir Peter Medawar argued, must always see results as provisional. On these foundations we must train our juniors and build our future.

WHO Change at the top

Published in Australian Medicine 3 July 2017 http://bit.ly/2sDQlXe