Today's Washington Post reports a survey of medical researchers at the National Institutes of Health showing that two in five are looking for other jobs as a direct result of the Administration tightening-up conflict-of-interest regulations to prevent them from outside consulting.
Of the NIH personnel who supervise outside contract research, many fewer are exploring an exit. The Post notes they have fewer outside consulting opportunities.
We'd observe that the conflict-of-interest regulations don't go far enough in preventing in-house scientists from commisioning studies to deliver "evidence" for agency policy choices. Now that we've destroyed the myth that government-paid scientists are without blemish or bias, let's take the next step and get some independent review of the contract science by such means as reinvigorating the Data Quality Act.
One need not allege scientific fraud to be concerned over documented -- even confessed -- evidence that NIH-funded researchers have cooked the books on major research that supports the policy direction favored by the government. An investigative report in today's New York Times Magazine , "An Unwelcome Discovery" by Jeneen Interlandi, reports the scientific fraud perpetrated by Dr. Eric Poehlman of the University of Vermont in his studies on hormone replacement therapy after menopause, supported by the National Institutes of Health with results confirming that agency's policy choices. Dr. Poehlman is now in jail.
Given that the media regularly give government-funded researchers a free pass on conflict of interest and virtually indict researchers for receipt of drug company or food company funding, the case is instructive. I'd note that the Salt Institute has no horse in this race; we report on peer-reviewed science, but we do not fund the research.
Interlandi explains why the Poehlman story matters:
The scientific process is meant to be self-correcting. Peer review of scientific journals and the ability of scientists to replicate one another's results are supposed to weed out erroneous conclusions and preserve the integrity of the scientific record over time. But the Poehlman case shows how a committed cheater can elude detection for years by playing on the trust - and the self-interest - of his or her junior colleagues.
. . . .
The length of time that Poehlman perpetrated his fraud - 10 years - and its scope make his case unique, even among the most egregious examples of scientific misconduct. Some scientists believe that his ability to beat the system for so long had as much to do with the research topics he chose as with his aggressive tactics. His work was prominent, but none of his studies broke new scientific ground. (This may also be why no other scientists working in the field have retracted papers as a result of Poehlman's fraud.) By testing undisputed assumptions on popular topics, Poehlman attracted enough attention to maintain his status but not enough to invite suspicion. Moreover, replicating his longitudinal data would be expensive and difficult to do.
"Eric excelled at telling us what we wanted to hear," Matthews, Poehlman's former colleague, told me. "He published results that confirmed our predisposed hypotheses." Steven Heymsfield, an obesity researcher at Merck Pharmaceuticals in New Jersey, echoed Matthews's sentiments and added that Poehlman's success owed more to his business sense and charisma than to his aptitude as a scientist.
"In effect, he was a successful entrepreneur and not a brilliant thinker with revolutionary ideas," Heymsfield wrote me via e-mail. "But deans love people who bring in money and recognition to universities, so there is Eric."
At his sentencing hearing, Poehlman took responsibility for his actions, but between the lines, he seemed to be placing some blame on the system that requires principal investigators to raise money for their research through government grants.
"I had placed myself, in all honesty, in a situation, in an academic position which the amount of grants that you held basically determined one's self-worth," he told the court in June. "Everything flowed from that." With a lab full of people dependent on him for salaries, Poehlman said he convinced himself that altering some data was acceptable, even laudable. "With that grant I could pay people's salaries, which I was always very, very concerned about."
He continued: "I take full responsibility for the type of position that I had that was so grant-dependent. But it created a maladaptive behavior pattern. I was on a treadmill, and I couldn't get off."
Interlandi quotes NIH spokesperson Sally Jean Rockey on the lessons to be learned. Rockey
said that lost grant money was not the only, or even the most significant, cost incurred. "Science is incremental," she said, explaining that most scientific advances build on what came before. "When there's a break in the chain, all the links that follow that break can be compromised." Moreover, she said, fraud as extensive as Poehlman's would inevitably lead to further erosion of the public's trust in science. Poehlman's sentence, she said, should send a clear message to the scientific community and the public at large that fraud would not be tolerated.
The story is a tragedy at several levels, of course. Besides landing him in prison and utterly wasting $2.9 million in NIH taxpayer investment, the Poehlman fraud misdirected medical advice given to thousands of post-menopausal women. Further research has shown dramatic health risks for Hormone Replacement Therapy -- another expensive case where a plausible theory was undone by controlled health outcomes studies.
Again, recounting this tragic story is not an underhanded way of alleging scientific fraud on the part of the NIH and its cadre of university researchers. It does illustrate quite clearly, however, that effective safeguards to ensure research integrity are lacking. It should cause all of us to be concerned about the potential for analytic bias by researchers whose funding (and career health) are determined by a government agency with an unswerving policy proclivity.
In the case of the health impacts of dietary salt, NIH-funded researchers have generally lined up behind their funding agency's policy conclusions. NIH has protected the researchers it's funded against having to make their data available for independent professional review required under the federal Data Quality Act. Again, without alleging fraud, could it be that the policy bias of the federal funders has allowed another intervention, like Hormone Replacement Therapy, to be promoted to the public without the scientific rigor of a controlled trial?
Indeed, there has been no controlled trial of the health outcomes of dietary salt despite the vocal advocacy of salt reduction based on extrapolations of blood pressure data as if that was the only metabolic impact of cutting dietary salt. Could this story be parallel to the Poehlman one? Interlandi points that Poehlman "had derived predicted values for measurements using a complicated statistical model. His intention, he said, was to look at hypothetical outcomes that he would later compare to the actual results."
Let's be charitable: if public health policy is to be based on "predicted values" of health benefit derived from a "complicated statistical model" as has been the case built for reducing dietary salt, perhaps it's time for HHS to heed our call for a controlled clinical trial of the cardiovascular outcomes (mortality and the incidence of heart attacks and strokes) of the pet NIH theory that cutting salt will save lives. Let's see the evidence.
Despite massive public education efforts and ubiquitous nutrition labeling, consumers don't appreciate the caloric impact of their portion choices and, if they exercise, self-righteously overcompensate by increasing their food intake. So concludes Cornell University professor Brian Wansink, as reported in today's New York Times . (free registration required)
He found that while most people think they make only 15 food decisions a day, they are really making more than 200. And his research with college students show a wide variety and many unexpected bases for these decisions. He takes shots at those "at 30,000 feet" who call for changes in the food system, school lunches and farm policy and he pans "nutritionists and diet fanatics" who beat-up on individuals for "bad" food choices. His approach is a series of practical habits to chip away at calorie intake.
Dr. Wansink's research took no cognizance of salt intake, but his conclusions invite a salt-related question. Among the unrecognized, even unconscious, food choices may be an inherent salt appetite. Perhaps a future study.
A story in today's Washington Post introduced the concept of "Big Salt" -- ostensibly, the Salt Institute is a powerful political force in Washington (see earlier post). Later in the day, I had a chance to read another story that quotes another expert: "Salt is big."
What a difference between the stories.
Peggy Townsend's "Salt Rocks " story in the August 30 Santa Cruz Sentinel (yes, I'm a bit backed up because of travel) makes the point that gourmet salts are all the rage despite a few naysayers like Robert Wolke:
Chemistry professor and author of the book "What Einstein Told his Cook," Robert Wolke told the Associated Press that mineral concentrations in salt are so small they don't contribute any meaningful taste to food. No matter how "unprocessed" gourmet salt companies say their products are, the act of evaporation - whether by wind, sun or machine - purifies out most minerals. And while someone might be able to tell the difference between certain salts when tasted raw, the flavors fade to nothing when added to food.
A salt-using chef begs to differ:
Michael Rech, executive chef at the California Culinary Academy, says no one will taste the difference if you use fleur de sel in the water you are using to cook rice.
But use it in pate or foie gras "and you get this all-around flavor of salt which you don't get from an iodized salt," he says. And, when you want to set out salt for a dinner party, nothing is better than a small bowl of blushing pink Himalayan salt or stunning red Hawaiian salt crystals.
"All you need is a pinch of the gourmet salts," says Jennifer Jones, who owns Jones and Bones food and kitchen shop in Capitola. "It's like a good olive oil or a balsamic vinegar."
Jones, who carries 13 kinds of salts and offers free salt tastings, says customers have long sought out the fleur de sel but with the popularity of rubs and brining are now branching out even further to flavored salts like fennel salt and truffle salt to enhance their dishes.
People are dusting lavender salt on scrambled eggs and sprinkling truffle salt into mashed potatoes. They're brining fish in Hawaiian sea salt and rubbing salt seasoned with cranberry, rosemary and orange oil into turkey or chicken.
"Salt," says Jones, "is big."
That's the kind of "Big Salt" we like to talk about.
It was somewhat of a surprise to read the Washington Post's latest conspiracy theory - it must be the influence of the Da Vinci Code.
No one has ever disputed the impact of salt on blood pressure, nor for that matter has anyone ever disputed the impact of the myriad stresses we routinely encounter on blood pressure. There is, however, a great debate on whether these impacts per se lead to negative health events.
Hypertension is not a proxy for death, nor is it a surrogate for cardiac disease. Yet the anti-salt lobby ask us to believe it is, without the benefit of any scientific data. They rely exclusively on epidemiological studies using hypertension as an end point, ignoring all other variables. They rely on the famous Intersalt Study (Brit. Med J., v. 297, July, 1988) which compared per capita salt consumption to blood pressure in populations around the world. What they did not do was compare salt consumption to longevity. Using the same Intersalt data on salt consumption and the US Census Bureau data on life expectancy across the world, the resulting curve draws the inescapable conclusion that those populations which consume the most salt live the longest! No joke, no fudging figures - those populations which consume the most salt live the longest.
Of course, there are many other factors involved in longevity just as there are many other factors associated with blood pressure, but it still remains that the more salt a population consumes, the longer they live.
Indeed, one of the most outspoken and effective British anti-salt advocates, when confronted with data from Japan, whose citizens are amongst the highest per capita salt consumers in the world and also have the longest lifespan, dismissed this simply by stating that they would probably live even longer if they didn't eat so much salt. Some analysis, some science, no?
Before we all go around hoisting placards claiming Bland is Grand, let's consider the science and the data a bit more carefully.
Rather than join in a constructive debate on the policy options based on scientific evidence, anti-salt activists continue to finger-point at personalities and "special interests" to divert public attention to the fact that scientific studies do not identify an improved health outcome from reducing dietary salt.
The latest blast, typified in today's Washington Post , attributes the controversy to economic interests including "Big Salt" -- the Salt Institute. I've submitted this response to the Post:
"Big salt"? As president of the Salt Institute: thanks for the compliment. A few years ago, Gene Weingarten's Below the Beltway profiled the Salt Institute as a prime example of the notion that even the smallest and most insignificant interests have a not-for-profit organization (see http://www.saltinstitute.org/pubstat/beltway.html) . But that's another matter.
The article says "Too much salt is bad for you, right?" By definition, "too much" is, well "too much" ergo "bad."
But who's to say that the amount of salt Americans eat (and we're very average around the world) is "too much"?
I guess it depends on who you ask. The Cochrane Collaboration, inventors of "evidence-based medicine" feel there is no evidence supporting a population intervention. So, too, does the U.S. Preventive Services Task Force, guardians at the HHS of the "evidence-based" approach to public health nutrition policy.
This is an enduring debate among scientists. While we don't fund research due to our modest means, we've seen the debate transform itself from the old debate: will lowering salt help a significant number of people reduce their blood pressure? to a new, better line of inquiry: will reducing dietary salt lower the risk of heart attacks and improve health outcomes?
Surprise. When the question is framed in terms of health outcomes, the answer is clear: none of the studies show a population benefit by reducing dietary salt. Some show increased risk. The president of the International Society of Hypertension published an article earlier this year, using a massive HHS database, and found 37% greater mortality among those following the Dietary Guidelines' recommedation.
We've reviewed the controversy on our website, http://www.saltinstitute.org/28.html and comment regularly on our blogs http://www.saltinstitute.org/rss/health-other/ and http://www.saltinstitute.org/rss/saltsensibility/ . We are a very transparent organization and you can also find all our public statements on this issue online at http://www.saltinstitute.org/advocate.html .
Dick HannemanPresidentSalt Institute
This may be David and Goliath, but we're not Philistines, in Webster's terms: "disdainful of intellectual values."
Carefully coordinated, even choreographed, the anti-salt campaign launched another publicity barrage today, announcing that the UK CASH (Consensus Action Against Salt) has been superseded by WASH, the World Action Against Salt. CASH experts (Dr. Graham MacGregor, et al) will be in Paris tomorrow and Friday, having persuaded the World Health Organization to host a one-sided symposium on salt to build pressure for action. The announcement was made in foodnavigator.com .
Meanwhile, the science is unchanged, trending against WASH as public health agencies consider whether their earlier focus on the blood pressure effects of salt reduction should remain the scientific focus or whether, as advocated by the presidents of the International Society of Hypertension and American Society of Hypertension, the focus should broaden to consider whether reducing dietary salt will improve public health .
Researchers from the University of California at Berkeley argue in an article published yesterday in the British Medical Journal recommending the "Parachute approach to evidence based medicine ," that there are times when it is unethical to wait for controlled trials of a health intervention. People die before the intervention is tested, they say, citing as their most impressive evidence the case of Oral Rehydration Therapy (ORT). They explain:
In 1980 childhood diarrhoea was killing an estimated 4.6 million children annually. Treatment with an intravenous drip is life saving but requires health facilities. Studies from 1977 onwards showed that infant diarrhoea could be treated with oral rehydration. The World Health Organization initiated a highly successful programme of oral replacement therapy in 1981 after it became obvious that the treatment saved lives and no alternative home based treatment was possible. Randomised controlled trials were later conducted in health facilities, confirming that oral replacement therapy was as effective as intravenous therapy. The initiation of large scale programmes for oral replacement therapy before the randomised trials meant that by 2000 there were three million fewer deaths from diarrhoea annually.
Treating diarrhea with a mixture of salt, sugar and water has, indeed, saved millions of lives. The authors advocate the "parachute" principle, explaining:
Evidence based medicine and randomised controlled trials are not synonymous. The parachute approach can be the most appropriate, especially in situations of high mortality and low resources, when a simple intervention can have a large impact. Randomised controlled trials are essential in many other settings and they have defined many life saving strategies and corrected some important mistakes. They are often needed when mortality has reached a low level because new treatments require large investment for relatively small improvements in therapy that may be difficult to distinguish.
All that may be well and good, but BMJ has also editorialized that they feel confident in recommending universal sodium reduction. Perhaps a caveat is needed before we call in the airborne assault on salt. In the case of ORT, the small scale studies produced strong consensus of a health benefit. While there is no such concensus that reducing salt would reduce blood pressure to a meaningfull degree, because the effect is so heterogeneous, the UC-Berkeley authors and BMJ editorial staff should be chastened by the consensus of the observational studies of low-salt diets -- there is no benefit in terms of reducing heart attacks or reducing mortality.
Let's not "parachute" in to reduce dietary salt -- at least until the clouds clear and we can see the landing area.
Used to be all dietitians would chant the mantra of varied diets where all foods could find a place. "We need to focus on the question of "good diets" and "bad diets," they'd say, and avoid labeling individual foods as "good foods" or "bad foods."
The science is unchanged, but the mantra is gone. When nutrition experts gather these days, they're shaking their heads and wringing their hands: the public doesn't "get it." While consumers pretty well understand the concepts of the dietary guidelines, they don't buy into them in terms of personal eating decisions. What to do?
Demonize foods, say some like the Center for Science in the Public Interest which has pushed the "good food/bad food" dichotomy for 30 years. Make people feel that the foods they eat are poisoning them. Ostracize foods with "bad" nutrients and limit diet choices to "good foods" with plentiful "good" nutrients.
The food industry is buying into the "good foods/bad foods" story too -- for marketing reasons. Food companies want to deliver what their customers want. If you can put a "healthy" label on your foods, it makes a difference in product placement and sales -- if you can make it taste good!
A new study reported by the European Food Information Council sums up this way:
There is widespread interest for nutrition information on food packages. Consumers generally understand the link between food and health, and many are interested in using information about the nutritional properties of the food they eat. However, the degree of interest differs between consumers and varies across situations and products. In addition, it can conflict with other interests in food, notably taste, traditional eating, and indulgence.
Consumers like the idea of simplified front-of-pack information but differ in their liking for the various formats. These include health logos, 'traffic lights', GDA-based systems and energy labels. Differences can be related to conflicting preferences for ease of use, being fully informed, and not being pressurised into behaving in a particular way. For example, many consumers like colour coding, but some regard reds and greens on food products as too coercive.
Most consumers understand the most common signposting formats in the sense that they themselves believe that they understand them and they can replay key information presented to them in an experimental situation.
There is still virtually no insight into how labelling information is, or will be, used in a real world shopping situation, and how it will affect consumers' dietary patterns.
The real question is will food buyers follow the red-yellow-green stoplight the same way they follow traffic speed limits -- by applying their own judgment in the absence of an officer writing speeding tickets? As EUFIC points out: "There is still virtually no insight into how labelling information is, or will be, used in a real world shopping situation." Are we ready to buy another set of unintended consequences?