Thursday, March 04, 2010

Science and the toxic scare machine

The excellent article below sums up much that I have been saying on this blog -- JR

United States Federal Agency-sponsored research in public health toxicology is as irresponsible and misleading as the misconduct recently uncovered at the U.N. Intergovernmental Panel on Climate Change (IPCC). Can't imagine anything as bad as the IPCC? How about thirty-plus years of panic-mongering about how the environment is a killer and (from the movie Aliens) "we're gonna die, man, we're all gonna die"?

Well of course we're gonna die, eventually. This scientific misconduct suggesting that we are going to die from the environment is intended to scare the most anxious and comfortable society in history. The research is the result of agency money spent to make the public more anxious and push the idea that government is a savior; regulations and programs must be instituted now to rescue us from Armageddon. More news at seven -- or in tomorrow's paper.

Adult professionals should be committed to good science and intellectual effort. In medicine, law, and all intellectual inquiry, we search for the best evidence. In public health research, unfortunately, the basic rules have been discarded in a shocking and disappointing way because the public health research community is poisoned by politics and funding influence. So the inconvenient scientific rules are ignored.

Epidemiologists study population effects, and toxicologists study negative effects. Sir Austin Bradford Hill, British icon of public health research, originated in the early 1950s nine criteria for proving toxicity. His first and most important criterion was evidence of a measurable and significant toxic effect. Other criteria include that the toxic effect proposed has to be plausible, has to make exposure sense, and should be evaluated to make sure some other thing is not in play. All the toxicology criteria are derivative of the effect. The rest of the criteria are sensible rules any momma could come up with. Read them here.

Public health bench studies on toxins expose rats or mice to extreme (just less than killer) levels of toxins. After the rodents are exposed, they are studied for effects or sacrificed and examined. When the researchers tally a death or find on autopsy a disease or a tumor, they assert they have found a toxin, and the public must be protected and warned. Any exposure to the toxin is dangerous. Agency regulators must step in and protect the society.

Population studies in public health look for effects from exposures, and the researchers work and grind small effects that don't prove anything but provide an opportunity to raise a question of toxicity. Even small effects that fail to prove toxicity then become important. The small effect is projected to the society as a big effect, and the researchers and agency pound the table and show projections that the small effect can produce thousands of sick or dead people.

The Federal Judicial Center is the educational institution for federal judges. Judges are designated the gatekeepers for evidence in all judicial affairs, and they make admissibility rulings all the time. The Judicial Center commissioned scientists and lawyers of high reputation to write the Reference Manual on Scientific Evidence 2nd Ed. 2000. The Chapter on Epidemiology was written by Leon Gordis, M.D.; Dr. P.H., former chair of epidemiology at Johns Hopkins; Michal Friedman, J.D., Ph.D., MPH of the National Cancer Institute; and Michael Green, J.D. of Wake Forest U. Law School. (See study here.)

At page 375, the authors favorably reference the Bradford Hill Toxicity criteria.

At page 384, they discuss the magnitude of toxic effect required in observational studies that are used in public health toxicology research: "The threshold for concluding that an agent was more likely than not the cause of an individual's disease is a relative risk greater than 2.0. Recall that a relative risk of 1.0 means that the agent has no effect on the incidence of disease."

When the relative risk reaches 2.0, the agent is responsible for an equal number of cases of disease as all other background causes. Thus, a relative risk of 2.0 (with certain qualifications noted below) implies a 50% likelihood that an exposed individual's disease was caused by the agent. A relative risk greater than 2.0 would permit an inference that an individual plaintiff's disease was more likely than not caused by the implicated agent.

As an example of EPA misconduct and bad science, none of the important studies on air pollution can claim to comply with the rule on size of effect. That's true of so many other toxicology claims from population studies used by the EPA and other government agencies. Most public health journals are full of studies that break this rule.

Why scare the public with bad studies and exaggerated warnings? That's easy -- follow the money, the power, and the noise. The agencies are the source of funding, and the scientists must find something an agency can work with, or they won't have any funding or job. If the journals don't let the authors bend the rules, then the authors don't get published, and their status as experts is compromised -- but the journals won't have much to publish, so it will compromise the survival of the journals that are part of the academic infrastructure.

Would climate scientists have work tomorrow if today the U.N. said the global warming panic was revealed as a hoax? Same for public health panics and toxicity scares: The academic researchers, agency apparatchiks, and research programs would shrivel if tomorrow the EPA said, "Sorry...we were exaggerating. The planet is actually pretty safe, and only a few things are really toxic. We're shuttin' down the panic division -- get on with your lives."

An overlooked effect of the aggressive agency policymaking based on weak or inadequate science is misdirection of resources. Environmental regulations and compliance requirements can cause economic disruptions, unemployment, and economic hardship. Negative economic developments affect human welfare and are proven by the public health research to cause premature death.

Government agency funding, research, and policymaking should be comprehensively evaluated and tested for validity, but also for risks and benefits.


A raw deal

Farms selling milk straight from the cow vex food regulators, but the demand isn't diminishing. Why can't people be allowed to take their own risks?

The word "raw" sounds like something exciting and maybe a little dangerous. It makes you think of bloody steaks and wrestlers and untanned hides. "Milk," on the other hand, evokes just the opposite: motherhood, kids with sippy cups, and Oscar-winning movies. Maybe it’s the uncomfortable juxtaposition of the two ideas that makes certain people so nervous about raw milk. As demand increases, state legislators, regulators and courts are all reexamining the issue of raw milk. But as some jurisdictions legalize while others crack down, farmers and milk drinkers are stuck in limbo.

Raw milk is simply ordinary milk that hasn’t been pasteurized. Pasteurization—the quick heating and cooling of fresh milk -- kills bacteria that can cause food-borne illnesses. When Americans first began pasteurizing milk at the turn of the last century, testing was rudimentary and farms were far less hygienic. Milk quality varied tremendously, transit was slow and the milk that made it into cities often veered into unsafe territory. Pasteurization —which eradicated Salmonella, E. coli and Listeria— saved lives.

Today, the situation is different. Testing for the presence of such pathogens is much more precise, and farms are far cleaner. While processing milk remains a good choice for milk shipped to the population as a whole, there are a group of food rebels who would rather drink their milk straight from the cow. Some say they prefer the taste, calling it richer and more robust. Others say that pasteurization kills beneficial enzymes and helpful bacteria along with the baddies. Whatever their reasons for drinking the raw stuff, the proliferation of raw milk devotees willing to take a small risk for better dairy makes regulators unhappy, and they are looking for ways to crack down on milk speakeasies.

Federal law prohibits the transportation of raw milk across state lines for illicit purposes (i.e. selling the milk to consumers rather than processors). But 23 states currently ban the sale of raw milk within their borders as well. When federal or state regulators come across suspicious milk, they have a bad habit of pouring the stuff out first and asking questions later—much to the dismay of farmers who rely on the milk for their livelihood. The Midvalleyvu Family Farm, near Milwaukee, recently drew attention when a Wisconsin state legislator took up its cause after hearing that the regulatory agency that enforces the state’s ban on sales of raw milk had been investigating the owners for months, demanding bank records and canceled checks in addition to contacts and invoices for the farm’s suppliers. Midvalleyvu had been selling raw milk in defiance of the law—but there had been no reported health problems or consumer complaints linked to the farm. Eventually the farm gave up selling raw milk.

But every time an outlet for raw milk gets shut down, a new one opens up, and fans find their way to the moo juice. In Pennsylvania, a Mennonite farmer named Mark Nolt has been a victim of the regulators’ zeal. Starting in 2008, state officials have repeatedly raided his property, confiscating equipment, destroying his inventory and harassing his family because they say he is selling raw milk and cheese in violation of state law. Feds showed up at another Pennsylvania homestead earlier this week, this time on the private land of Amish farmer Dan Allgyer, with a similar mission.

As it stands, the future of raw milk is far from clear. Pennsylvania lawmakers are working on revisions to close loophole in the state’s raw milk laws and the Cheese Reporter (yes, there is such a publication) reports that the FDA may be gearing up to tweak the rules on the aging of domestic raw milk cheese as well. But in other areas of the country, thinking on the issue of raw milk is evolving toward more choice for consumers. Two bills to legalize the sale of raw milk have been introduced in Georgia, for instance. And six other state legislatures are debating the issue as well.

Stephen Sundlof, director of the Center for Food Safety and Applied Nutrition of the U.S. Food and Drug Administration, said raw milk drinkers are getting “pretty clever” these days. In Canada, a test case recently yielded a victory for raw milk drinkers. Ontario farmer Michael Schmidt was vindicated by the Canadian courts in late January after three years of legal squabbling. While raw milk is legal to drink in Canada, it is illegal to sell. Dairy farmers, unlike their bovine charges, can be a pretty sharp bunch. Schmidt was distributing raw milk, but avoiding regulations by selling his customers a one-quarter ownership stake (good for six years) in each of the 150 cows he keeps at $300 a pop. They own the cow fragment outright, but pay him to provide milking and delivery service. The court ruled that this system was within legally permissible boundaries. (Note that another place this arrangement has cropped up is California, where marijuana cooperatives help medical pot patients work around a similar legal-to-use, illegal-to-sell situation. Contraband is contraband, no matter whether you smoke it or drink it.)

Raw milk is a hot issue right now, with state, local, and federal governments reevaluating their stance on milk as consumer demand increases. The rulemakers have a choice: They can work with the customers they are supposed to be protecting to help them get what they want, or they can declare raw milk drinkers and sellers the enemy and persecute them. Sundlof recently called the “continued and escalating interest in raw milk consumption” a “problem for this industry, and certainly it’s a problem for the FDA.” It’s precisely that attitude that is driving raw milk producers underground and into increasingly elaborate legal arrangements. And while lawmakers and bureaucrats dither, an awful lot of law-abiding farmers are finding that their milk is going sour and their patience is running out.


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