What Statins, Trans Fats, and GMOs Tell Us About Scientific Controversies

Climate denial has rightly lead many to unilaterally embrace science as the last bastion of rational thought in an increasingly contentious world. But the question is:science?
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Climate denial has rightly led many to unilaterally embrace science as the last bastion of rational thought in an increasingly contentious world. But the question is: Whose science?

It's the role of science to provide the criteria for determining how our society regulates, monitors, and controls both health-promoting substances and contributors to health and environmental harm. Each such decision can have far-reaching consequences -- and long-term costs. And that's why when controversies erupt, all debate participants lay claim to the scientific truth.

When in a Scientific American blog Kevin Bonham (a sixth-year Harvard graduate student) writes that he takes "the position that the National Academies, the American Association for the Advancement of Science, the American Medical Association, the European Commission, and the Royal Society take," merely citing these august organizations sounds convincing to the average person.

Yet despite claims of consensus, scientific findings are rarely absolute because it's the nature of science to evolve. Research occurs within a human, social, and economic context. Given the business drivers influencing both medical and other forms of scientific research, most science is nowhere near as definitive as climatology. As a result, the certainty we seek from science will sometimes -- if we are honest -- evade us. And even major scientific organizations (like those Bonham cites) get it wrong, for reasons I'll highlight in this blog post. Five recent happenings in ongoing scientific debate reveal that informed people cannot afford merely to take all scientific "evidence" at face value.

Statins Redux

In a recent op-ed in The New York Times, Harvard's John D. Abramson, M.D., author of Overdosed: The Broken Promise of American Medicine, and cardiologist Rita F. Redberg, M.D., critique newly released medical guidelines that advise statin prescriptions for an additional and sizeable new segment of the population -- increasing the pool of recommended users by as much as 70 percent. According to Abramson, the guideline change, issued by two respected medical authorities, the American Heart Association and the American College of Cardiology, "may sound like good news for patients, and it would be -- if statins actually offered meaningful protection from our No. 1 killer, heart disease; if they helped people live longer or better; and if they had minimal adverse side effects. However, none of these are the case."

Abramson goes on to enumerate the numerous problems with these most widely prescribed and profitable pharmaceuticals. He covers the precise concerns I detailed in a September 2013 article published on Alternet.

So why did major medical organizations expand the guidelines to encompass millions more Americans? John Abramson comments:

The process by which these latest [statin] guidelines were developed gives rise to further skepticism. The group that wrote the recommendations was not sufficiently free of conflicts of interest; several of the experts on the panel have recent or current financial ties to drug makers. In addition, both the American Heart Association and the American College of Cardiology, while nonprofit entities, are heavily supported by drug companies.

Nor is this a rare instance of business goals impinging on science. When the American Academy of Pediatrics endorsed guidelines for acne treatment via prescription acne drugs (a billion-dollar industry), a reporter at the Milwaukee Journal Sentinel noted:

[Thirteen] of the 15 experts who drafted the guidelines were paid consultants or speakers for companies that market the drugs recommended in the guidelines. ...
The organization that developed the guidelines -- paid the academy to publish them -- received 98% of its 2011 revenue from companies that make acne drugs.

Yet when scientific claims are made, rational people want to trust them. We forget that the pharmaceutical and other industries have the resources not merely to influence elections but to garner boards of scientists, generate organizationally endorsed studies, assemble think tanks with slick websites, publish journal articles, and buy ads and PR strategies. By contrast, those presenting evidence through independent research may be too readily dismissed for smaller cohorts or criticized in ways that breed confusion about the validity of their results.

Trans Fats

In 1978 lipid researcher Mary Enig, Ph.D., was the first to publish data connecting consumption of trans fats to health concerns including cardiovascular illness and cancer. Her findings contradicted the medical consensus of the 1960s, 1970s, 1980s and beyond, which advised people to eat trans fats to prevent heart disease. Ironically, it was the American Heart Association (the same organization that recently expanded statin guidelines) that asserted this now-debunked science. Publications, appointments, and research grants followed the scientific consensus of the day, as they do today. Representatives of Kraft Foods and Lever Brothers (and their advisors) visited Enig, as she recounts in a long essay. They made attempts to get her published research retracted.

A 1987 Nurse's Health study conducted by Harvard scientist Walter Willett confirmed Enig's findings. In tracking the nutrition of 85,000 nurses for eight years, the study found that those with high intake of trans fats had an increased (not lessened) risk of heart disease.

Over 25 years later, this past month, the FDA belatedly acted on the scientific evidence by moving to recategorize and ban trans fats.

From the time that the first researcher sounds the alarm, there may be more than a generation of controversy before regulatory agencies read the memo that yesterday's scientific certainty unraveled. The present-day snapshot offered by many scientific findings is like a single frame of an epic movie that continues to play. This is true for all science. A recently released study by leading climatologist James Hansen reveals worsening projections than formerly indicated. Given the ever-evolving nature of scientific understanding, it's hard to determine at the outset the long-range health risks of novel synthesized ingredients or processes. Unlike natural foods or substances consumed for centuries, the side effects or downsides of synthesized products (or processes) may only emerge with time and study. But as with statins, acne medication, trans fats, and high-fructose corn syrup, business imperatives drive the introduction of novel substances (and activities) before they have been fully vetted.

Settling controversies requires research conducted outside the web of entangled authorities and organizations. And when that research is undertaken by scientific whistleblowers like Enig, we can expect the chorus of establishment scientists to defend the status quo.


For example, last week, the Elsevier publication Food and Chemical Toxicology (FCT) retracted its 2012 publication of Dr. Gilles Séralini's animal research. Rats fed GMO foods developed long-term toxicity as well as tumors, in contrast to rats in the control group. Since its publication, the study has been attacked by an assembly of august medical organizations, yet most of its findings still stand.

The Elsevier editor, Dr. Wallace Hayes, makes clear that the decision to retract the article came about due to pressure from unnamed scientists and scientific organizations, who ultimately conducted a behind-the-scenes review. Since the reviewers were not disclosed, it is impossible to ascertain any potential conflicts of interest. Hayes' rationale for the retraction is that Séralini's "results (while not incorrect) are inconclusive, and therefore do not reach the threshold [for] publication."

According to a response from the European Network of Scientists for Social and Environmental Responsibility (ENSSER), scientific publications abide by certain agreed-to guidelines for retractions, and "inconclusiveness" is not among them. ENSSER points out:

'Conclusive' results are rare in science, and certainly not to be decided by one editor and a secret team of persons using undisclosed criteria and methods. Independent science would cease to exist if this were to be an accepted mode of procedure. ... Most notably, Séralini and his co-authors did not draw any definitive conclusions in the paper in the first place; they simply reported their observations and phrased their conclusions carefully, cognizant of their uncertainties. This is because the paper is a chronic toxicity study and not a full-scale carcinogenicity study ... The authors did not intend to look specifically for tumours, but still found increased tumour rates.

ENSSER stated that all the rationales for retracting the study were considered at the outset "by the peer reviewers of the journal, who decided they formed no objection to publication" rendering the retraction a "travesty of science ... [that] looks like a bow to industry." A summary of the ENSSER statement can be found here.

Claire Robinson of GM Watch points out that the retraction "follows FCT's appointment of Richard E. Goodman, a former Monsanto scientist and an affiliate of the GMO industry-funded group, the International Life Sciences Institute, to the specially created post of associate editor for biotechnology at the journal."

Despite the assertions of scientific consensus on GMOs in Scientific American, Forbes, and elsewhere, in 2013 a group of over 200 international scientists signed a statement declaring that there is "no scientific consensus on GMO safety."

Industry's Hand on Science

Rather than instilling trust that any given set of scientific findings is definitive, the debacle over statin guidelines, the banning of trans fats, the GMO animal study retraction, and a range of other controversies unmask this dilemma: People must respect science while also maintaining a healthy skepticism.

In fact, the spirit of scientific inquiry requires us to distinguish between valid scientific consensus (which exists for climate change, and the health dangers of trans fats and high-fructose corn syrup) and arenas where scientific questions continue to emerge -- despite attempts of vested science to close the door on legitimate concerns.

John Abramson adds:

The American people deserve to have important medical guidelines developed by doctors and scientists on whom they can confidently rely to make judgments free from influence, conscious or unconscious, by the industries that stand to gain or lose.

And the same holds true for other areas of scientific controversy. When medical journal publishers such as Elsevier attempt to suppress or discredit legitimate research (like Séralini's), "it will decrease public trust in science," predict the ENSSER scientists. "And it will not succeed in eliminating critical independent science from public view and scrutiny. Such days and times are definitively over."

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