The May 17 edition of National Review Online contained an article entitled "Salt Sense" by Bruce Bartlett. The article makes the point that budget deficits and immigration (legal and illegal) "are benign up to a point." So far, so good. But Mr. Bartlett introduces the concept comparing it to dietary salt intake.
Analogy is a powerful tool. Painting mental pictures embeds thoughts into memory. Mistaken analogies either perpetuate error or undermine the author's argument. Since Paracelsus, we've all understood that "the dose makes the poison" and that all organisms can tolerate sub-toxic exposures (perhaps we should exempt the State of California's Proposition 65 from this generous assessment). But Mr. Bartlett's "favorite example" is mythologic. "Too much salt," he says, can be problematic. Sure. "Too much" of anything, by tautologous definition, is excessive. His implication is clear: above some amount that humans might ingest, "salt can create physical problems such as high blood pressure." That may be Mr. Bartlett's opinion, but not a medical consensus. He continues that "a large quantity of salt consumed within a short time will kill you." Misleading at best. If a human were fed any substance intravenously, such as increasing the concentration of the perfectly safe saline used in emergency medical procedures, doubtless it could be fatal, but humans cannot ingest such amounts; their intolerant stomachs would rebel and regurgitate such amounts. As for blood pressure, we've known for four millenia of the relationship of salt and blood pressure, but there is no consensus that salt intake "causes" hypertension ("high blood pressure," a defined medical term). Hypertension is an important indicator of "physical problems" but, itself, only a risk factor, not a health outcome. We are rightly concerned that blood pressure is a strong predictor of adverse health outcomes such as heart attacks, but there are other risk factors involved. Not a single study examining the relationship between the amount of salt consumed in the American diet and either heart attack rate or to how long people live, has found that "excessive" salt intake is associated with higher rates of heart attacks or with lower mortality . In fact, the latest study, by the current president of the International Society of Hypertension, published in the March issue of the American Journal of Medicine , found that Americans who ingest the government-recommended amount of salt, actually had a 37% higher mortality. Low-salt dieters died more frequently. This is because salt serves multiple metabolic purposes and reducing salt, for example, increases insulin resistence, a risk factor for diabetes, and plasma renin activity, a strong predictor of myocardial infarction. There is no controlled trial showing that reducing dietary salt improves health outcomes. None of this, of course, should impune Mr. Bartlett's logic: the dose, indeed, makes the poison. It's unfortunate that his easy adoption of a popular myth in his "favorite example" might tend to undermine the credibility of his argument.
Frank Greve of Knight Ridder Newspapers just did a syndicated story on "20 things we could do to be healthier ." As Sherlock Holmes would have observed, it was notable for "the dog that didn't bark": despite the drumbeat of advice from publc health officials, former US Surgeon General David Satcher led an alliance of health insurers, state health departments, academics and trade groups as they tried to answer the question of which preventive measures could keep us healthiest for the least money. They reviewed more than 8,000 preventive-medicine studies.
Before announcing the results, keep in mind that universal salt reduction is touted as providing its benefits at virtually no cost. Now, the envelope, please: Unmentioned in the "Top 20" was anything about salt.
Academics, public health experts and association leaders met yesterday at the National Press Club to discuss "The World Health Organization: How can the United Nations agency fight disease inthe 21st century. " The event was sponsored by the Hudson Institute.
Promising "diagnosis and prognosis," the experts delivered some valuable insights and advice for WHO, culminating in a powerful address by Dr. Gail Wilensky, a member of the WHO Commission on Social Determinants of Health and head of Pres. George H.W. Bush's Medicare and Medicaid program and one of America's "Top 25 Women in Health."
The group intended to catalogue ideas, not produce concensus and, indeed, opinions were disparate. Some highlights:
Amir Attaran, PhD of the University of Ottawa, decried WHO's focus on visible problems at the expense of public health realities, urging the agency to show more respect for science and confine its activities to its areas of competence (avoiding "mission creep").
Nicole Bates of the Global Health Council outlined the importance of partnerships, particularly with the private sector, a point reinforced by Jean-Luc Poncelet, M.D. from the Pan American Health Organization (PAHO) who also reminded the group that the real work gets done at the country level, not in Geneva. I added that involvement of private sector partners enhances the likelihood that program initiatives will be real-world and sustainable, using the example of the salt industry's active partnership to combat Iodine Deficiency Disorders. Several responses credited the salt industry with enlightened and effective leadership.
Mary Pendergast, FDA deputy director under Dr. David Kessler under Presidents Bush and Clinton, suggested WHO focus on eradicating infectious diseases where it has enjoyed success rather than tackle chronic diseases where its record is spotty (or worse). I added that perhaps the true dichotomy was not infectious versus chronic, but rather interventions for which well-accepted interventions were being applied (as is the case in infectious diseases and some chronic conditions such as smoking) versus interventions recommended for chronic diseases which remain controversial due to lack of health outcomes trials of the specific interventions such as restricting dietary salt.
My take-away message for reforming WHO for the 21st century:
1. Make a concerted effort to identify the best science and confine intervention initiatives to those well-supported by the evidence.
2. Conduct honest consultations and actively engage with private sector partners to fashion sustainable program responses to health challenges.
3. Become more involved in providing assistance to the 192 member health ministries to create and maintain FDA-type regulatory bodies in their countries.
Thank you Hudson Institute and program chairman Dr. Carol Adelman, director, (Hudson Institute) Center for Science in Public Policy .
I'm sure it's reported elsewhere, but yesterday's Boston Globe carried a story of House Appropriations Committee approval of an amendment by Rep. Rosa DeLauro (D-CT) to the FY07 agriculture appropriations bill scheduled for House debate next week. DeLauro's amendment would give the US Food and Drug Administration authority to compel drug makers to conduct clinical trials of drugs after they've been made available for consumer use. The amendment stemmed from a recent General Accounting Office report criticizing FDA's post-marketing drug safety efforts.
FDA has requested post-approval trials for 73% of new drugs the Agency approved from 1988-2003, but two-thirds of those trials have not been completed, GAO found. Over the past decade, there have been a number of FDA-approved drugs that have been determined to have unexpected adverse side-effects forcing their approval to be rescinded or to have been found to be ineffective.
While Congressmen can disagree whether FDA has enough authority already, and PHARMA may counsel patience in awaiting the results of these long-term trials, it's pretty much agreed that government health regulators are human and despite their expertise, they cannot always make the right call in recommending approval of a particular pharmacologic intervention. Some system of reconsidering the safety and effectiveness of the approved pills must be done afterwards to make sure they work as intended and improve health outcomes.
If it's true for pills, why not, then, for policies?
Of course, the example is salt. A quarter century ago, FDA led the charge encouraging a non-pharmacologic intervention for every American -- eat less salt. It was a policy, not a pill, but the question remains: was FDA approval of this non-pharmacologic intervention safe and efficacious? What post-approval clinical trials have been done to show that it has worked and improved health outcomes as predicted -- lowering the incidence of heart attacks and reducing cardiovascular mortality? After all, it was deemed so important that no trials could be undertaken at the outset -- "everyone" knew it would work and repeatedly proclaimed "at least it can't hurt anyone."
So, what now, post-approval?
Well, short answer: there's been no controlled trial. There have been 13 observational studies of the health outcomes of those who followed FDA's advice. Funny thing, though, none of them showed the American public to be better off. Heart attacks weren't reduced (some studies say the low-salt group had more heart attacks), mortality for low-salt dieters wasn't reduced (in fact, the latest study says those eating the FDA-approved 2,3000 mg/day of sodium actually died 37% more). Dreadful news for an FDA whose drug approval record is already under attack.
So, if salt reduction were a pill and not a policy, the DeLauro Amendment would compel FDA to come clean and move immediately to withdraw its approval of this intervention until a controlled trial could prove that it works and improves health. So far there's no evidence that such a trial would validate FDA's hoary determination 25 years ago.
Elected members of our legislative and executive branches of government sometimes leave office at the low point of their careers as a direct result of the process of public accountability. Federal judges hold their posiitons with a lifetime tenure and news of their retirement usually merits little comment. Not so with 4th Circuit Court of Appeals Judge J. Michael Luttig who announced this week he will step down at age 51.
A year ago, Judge Luttig was on President Bush's short list for nomination to the U.S. Supreme Court. Passed over twice in the past year for that appointment and, then, almost exactly two months ago, the author of an embarrassing opinion in Salt Institute v. Leavitt , the trajectory of Judge Luttig's starred career turned down and is now history. Celebrated for strong defense of limited government (the Wall Street Journal editorialized that "his opinions have been prominent in setting the limits of executive and judicial power...."), Judge Luttig's Salt Institute opinion swung 180-degrees from that record and reversed clear Congressional intent that federal agencies be required to ensure that data used in their policy pronouncements meet high quality standards, be fully disclosed and succeptible of being reproduced by outside experts. Judge Luttig's opinion, rather, declared that agencies could make their own decisions about whether they'd met their obligations under the Data Quality Act. He put the fox in charge of the henhouse.
No doubt, Judge Luttig rendered valuable service through most of his 15 years on the appelate bench. It's too bad one of his final decisions was probably his worst ever.
By unhappy coincidence, today's news included two otherwise-unrelated stories: an outstanding article from Elizabeth M. Whelan, Sc.D., M.P.H., president of the American Council for Science and Health, "Public Health's Credibility Crisis " (from the Skeptical Inquirer) and a real life example confirming her worst fears.
First, Dr. Whelan:
"As society grapples with a possible avian influenza epidemic, threats of biological and chemical terrorism, AIDS, cigarette smoking, drug abuse, obesity, and more, it is vital that public health professionals present reliable scientific information and that the credibility of the public health profession be beyond reproach. In recent years, however, a worrisome trend has emerged: many in the public health community appear to be promoting politics and ideology over sound science. The slippage of public health science into pseudoscience and agenda-driven initiatives has been going on for some time."
She has her own examples offered as evidence of the threat. Let me offer my own recent disappointment.
As I reported earlier on the Salt Institute's "water conditioning" RSS feed, last week, the World Health Organization sandbagged the water treatment industry and plans to produce guidelines that would have public drinking water systems ensure that the water they provide contains at least minimum amounts of calcium and magnesium, two nutrients under-consumed in the U.S. and much of the world. No one disputes the need for calcium and magnesium, but drinking water is hardly the best delivery vehicle.
Experts in nutrition and drinking water gathered in Baltimore, MD, April 24-26 to discuss whether remineralizing drinking water with low amounts of calcium and magnesium would advance public health. I attended the symposium and participated in the discussion.
The symposium was organized by the National Sanitation Foundation and the International Life Sciences Institute on behalf WHO. WHO had been asked by its Middle East office whether water from reverse osmosis or distillation desalination plants was unhealthy because nutrients had been removed.
The experts agreed on several key points: 1) calcium and magnesium are vital nutrients and generally under-consumed and it is necessary to remineralize water from desalination plants in order to prevent it from aggressively attacking the pipes by which it is delivered to homes and businesses. They also agreed that ecologic studies (observational studies of the relationship between variables such as nutrients in drinking water and the incidence of cardiovascular (CV) events, are an inappropriate and under-powered analytic tool to use in determining public health policy.
No consensus emerged, however, on the key policy question of whether drinking water system operators should meet minimum mineral standards just as they now control for "maximum contaminant levels" (MCLs). Experts lamented the weak research in the area. Dr. Martha Sinclair from Australia, for example, noted the need for "substantial improvements on the evidence" and Dr. Richard W. Morris who directed the British Regional Heart Study said his large database offered no support for the conclusion that having calcium and magnesium in drinking water improved CV risk. Purdue University's Dr. Connie Weaver said a more effective strategy would be to increase dairy intake. Swedish professor Ragnar Rylander summed up: "We cannot prove that a small increase in calcium or magnesium consumption will have beneficial health effects." Leading opposition to the WHO initiative, Joe Harrison of the Water Quality Association (a speaker at this year's Salt Institute annual meeting), pointed out that buffering chemicals are needed to protect pipe systems, but that any health concerns about soft water pertain only to naturally soft water - as found in a quarter of U.S. cities - and water softened in an ion-exchange water softener. Softened water does not attack pipes, he noted. Other engineers pointed out that failure to ensure proper buffering to control pH would result in drinking water being contaminated with heavy metals from the pipes. WHO sequestered selected scientists on April 27-28 to draft a report on the subject. At that meeting, WHO staff pushed through a "consensus" report endorsing the staff's determination to recommend minimum amounts of calcium and magnesium for drinking water.
Much as it did in "managing" objections to its interventionist staff priorities, the World Health Organization (WHO) is on the path to establishing a guideline that all drinking water would be deemed "healthy" if it contains minimum amounts of calcium and magnesium. One quarter of U.S. cities don't have the target minimums, though federal law does not allow consideration of such minimum standards so at least Congress can protect us, right? Symposium participants were promised a look at the draft recommendations, but my personal experience testifying to WHO in Geneva is that the staff routinely ignore "public" comments inconsistent with the staff-driven policies they favor.
The scenario sounds like WHO's Report 916 all over again. Report 916 of two years ago was an attempt by WHO staff to create policy advocating salt (and other dietary) restrictions in the name of combating obesity. That report was so controversial it was not endorsed by the World Health Assembly composed of the 182 health ministers of United Nations countries. Could be a replay.
Many U.N. initiatives -- and many public health initiatives -- have foundered as they pursue objectives inconsistent with political realities or with, in this case, the science and engineering of public water supply systems. It seems such a waste of precious credibility