High ethical standards in the supplement industry

Talking Points Memo and other media have been covering the many thousands of dollars in allegedly unreported gifts from dietary supplement industry executive Jonnie Williams to Virginia Governor Bob McDonnell and 2005 Republican gubernatorial candidate Jerry Kilgore.  Star Scientific, Williams' company, markets a product called "Anatabloc" for its supposed anti-inflammatory benefits.

Records maintained by The Virginia Public Access Project show that Star Scientific gave over $250,000 in campaign contributions in Virginia between 1999 and 2011. Much of that money went to McDonnell’s gubernatorial campaign and leadership PAC between 2009 and 2011. But the top recipient of Star Scientific donations during the 12 year period was actually Kilgore’s 2005 gubernatorial campaign. Star Scientific contributed $101,462 to the Kilgore campaign between 2002 and 2005. And Williams personally chipped in another $27,323. 

The FBI is investigating gifts from Jonnie Williams to McDonnell and members of his family in the growing scandal.

The Star Scientific website includes the usual supplement industry misdirection, hinting at medicinal effects while taking care not to state these claims in plain language.  For example, a news release hints at what disease Anatabloc's supposed anti-inflammatory properties could treat: "The company also reported positive results from a study conducted by researchers at the University of Virginia Medical School investigating the effects of anatabine in an animal model of idiopathic inflammatory bowel disease, ulcerative colitis."  If the company actually claimed to treat a medical condition or disease, FDA would require the company to prove safety and efficacy in human trials.  With mere hints, the company is not obliged to prove anything in human trials.  All of this is typical for supplement company websites.

The real gem of the Star Scientific website is the lovely "Code of Ethics."  It has delightfully specific warnings against seeking to influence government officials through gifts.

When working with government agencies and officials, we must know the regulations and policies governing our conduct. What is acceptable practice in the commercial market may violate strict rules and regulations in government interactions. In all our dealings with governments, our actions must comply with applicable laws and regulations. Do not offer or provide gifts, gratuities or political contributions or discuss employment opportunities with a government official. Even paying for a business meal is prohibited by some government policies. To prevent legal problems for ourselves or the Company, and because laws differ throughout the country, you should work closely with Star's General Counsel when dealing with the government.

Perhaps Jonnie Williams and other Star Scientific executives will pull this dusty old document out of the company files and give it a second read.

What business model lets a person represent a neighborhood?

First, consider this 1999 article in the New York Times, which quotes community activist and businessperson Majora Carter on the topic of a garbage transfer station that had been proposed for the South Bronx.  This 1999 argument pitted (on the one side) an African American-owned business and a clean-air environmental group in favor of the transfer station against (on the other side) community advocates concerned about pollution from the transfer station.

The opponents shouted down representatives of the garbage company, saying the area already handles more than its share of garbage. They also accused the South Bronx Clean Air Coalition, which traditionally has opposed such projects, of accepting money from the company in exchange for its support.

''You are accepting money from them and playing their community partner,'' Majora Carter, an official with the Point Community Development Corporation, shouted at members of the South Bronx Clean Air Coalition. ''This is obscene.'' ...

''I don't care if it's a minority owned business,'' Ms. Carter, of the Point, who is also black, yelled at Mr. Jones at the public meeting. ''I'm a businesswoman too. I would not sell out my brothers and sisters that way.''

Later, but only later, read the harsh article today about Majora Carter in the New York Times.  This article may be unfair to Carter.  Yet, perhaps, Carter may have been too harsh in her criticism of Robert Jones, 3rd, and the South Bronx Clean Air Coalition in 1999.

For me, the lesson is two-fold: (a) we should have very high expectations for the ethical standards of our public interest organizations and entrepreneurs, and yet (b) these expectations should not be so high as to be impossible for any thriving operation to satisfy in the real world. 

Just like for-profit organizations, public interest organizations need a viable business model.  They may aim for small local impacts with cobbled together funding, or they may aim for larger impact with more substantial funding.  In the latter case, they must be vigilant about conflicts of interest and transparent about funding sources, but being a businessperson is not itself a sign of corruption.  Notice that even in the 1999 article, Majora Carter always described herself as a businesswoman.

[I had been thinking about similar issues in this February post.]

WSU invites Michael Pollan to speak

As you saw in the comments section on the U.S. Food Policy post about the Washington State University (WSU) controversy, food safety attorney and WSU alum Bill Marler issued a challenge to the university.

University officials had claimed that financial problems were responsible for the cancellation of a freshman orientation reading program centered on Michael Pollan's Omnivore's Dilemma. Others had implicated pressure from state agribusiness interests with influence in university leadership. Marler's challenge, designed to distinguish between these two theories, was to offer to write a check himself for a visit by Pollan to the WSU campus. If the university's problems were really financial instead of political, Marler reasoned, it would accept his offer.

WSU accepted Marler's offer, the attorney's blog reported yesterday afternoon.

I knew it was the economic pressures that public education is facing and not any political pressure that caused the change in the reading of Omnivore's Dilemma and Michael Pollan's visit to Pullman. The WSU I graduated from and served, would not bend to that kind of small mindlessness.

Why be cynical? Who cares if the attorney is enjoying a bit of grandstanding? Why quibble about inconsistencies in the university's original position? What's the point in asking whether Pollan really needed either the additional publicity or the speaker's fee? This outcome makes everybody look better than they would under any alternative scenario.

WSU decision brings heightened attention to Michael Pollan's Omnivore's Dilemma

In a revealing irony, from which cowardly university officials everywhere may have something to learn, the decision by Washington State University (WSU) officials to cancel Michael Pollan's Omnivore's Dilemma as the common reading assignment for freshman orientation next year is raising the book to new heights of notoriety and importance in that university community.

Reports today in the Spokesman-Review and the Chronicle of Higher Education (pay site) make a plausible case that pressure from Washington agribusiness interests may have been behind the cancellation. One faculty colleague, who asked not to be named in connection with this controversy, told U.S. Food Policy that WSU has its own Pacific Northwest character that distinguishes it from traditional agricultural universities in other regions.

That said, WSU Regents include politically powerful farmers and ranchers such as former Regent Peter Goldmark who ran for U.S. Congress in 2006 and is currently Washington State Commissioner of Public Lands. With extreme budget pressures, I understand how this could happen, but I don't like it.

I imagine this foolishness will triple the number of incoming students at WSU who read the book.

In any case, it was never going to be possible to suppress engagement of these issues at Washington State. A different faculty member, economist Trenton Smith, just this semester shared a provocative and ambitious essay (.pdf) about market power and information economics in industrial food production. An excerpt:

[O]ver the course of the last century, the U.S. has witnessed a dramatic shift away from traditional diets and toward a diet comprised primarily of processed brand-name foods with deleterious long-term health effects. This, in turn, has generated increasingly urgent calls for policy interventions aimed at improving the quality of the American diet. In this paper, we ask whether the current state of affairs represents a market failure, and—if so—what might be done about it.

In a way, Trent's essay is an economist's reflection on the issues raised by the tradition of food industry criticism exemplified by Pollan. A while ago, when I reviewed Omnivore's Dilemma for the American Journal of Agricultural Economics, I encouraged professional colleagues to read the book in exactly this spirit -- to wrestle with it, criticize it, and be inspired by it to work on novel economics questions that have been neglected by the mainstream literature.

Regarding today's controversy, Smith says, "I have discussed (and will continue to do so) Pollan's work in my undergraduate food / commodities marketing course, and it would have been great to expand the discussion to the rest of the student body." He adds, "I also find it ironic that this was all happening around the time I issued a working paper on the insidious influence big business has historically had on consumer access to information about food!"

Update: See also Tom Laskawy at Grist.

Industry thwarting research

As the economy continues to slump, publicly funded research is also drying up. Are there risks associated with private industry funding research, and if so, how do we, as citizens, read research with a concerning eye? An article published in the New York Times yesterday by Andrew Pollack: Crop Scientist Say Biotechnology Seed Companies Are Thwarting Research addresses biased research in agriculture.

A statement made to the Environmental Protection Agency (EPA) by 26 scientists was posted to a non-rule making docket titled: Evaluation of the Resistance Risks from Using a Seed Mix Refuge with Pioneer's Optimum AcreMax 1 Corn Rootworm-Protected Corn. The statement says:

"Technology/stewardship agreements required for the purchase of genetically modified seed explicitly prohibit research. These agreements inhibit public scientists from pursuing their mandated role on behalf of the public good unless the research is approved by industry. As a result of restricted access, no truly independent research can be legally conducted on many critical questions regarding the technology, its performance, its management implications, IRM, and its interactions with insect biology. Consequently, data flowing to an EPA Scientific Advisory Panel from the public sector is unduly limited."

In other words, some scientists feel as if industry has a chokehold not only on the research that is being conducted, but on what is actually being disseminated to the public. This research problem is largely under-reported and under-addressed to a science illiterate public. An article by the Committee for Skeptical Inquiry called Who's Getting It Right and Who's Getting in Wrong in the Debate About Science Literacy, dives deeper into this equally important issue. You can add science based blogs to your RSS here.

Research should be a public good and government should be conducting research to protect the well-being of its citizens from corporate strongholds. Another example of the system failing by Tom Philpott of the Grist is in the issue of Why is the FDA unwilling to study evidence of mercury in high-fructose corn syrup? I would argue much has to do with attractive jobs. The Crème de la Crop of scientists and researchers are easily enticed by high paying jobs in industry, not in regulatory positions at FDA. The FDA lacks man power and funding. On the flip side, those who are working in for the public interest (i.e. the scientists who just published their statement to the EPA) are being manipulated as well.

A professor at Tufts, Sheldon Krimsky, has done extensive work on the effects of industry on research. He argues that a series of laws, federal policies and court decisions have enabled private interest "stakeholder science" to gain influence over university research. His book "Science in the Private Interest"sparked a website that continues to address these issues.
The key to change, Krimsky says, is separating the financial interests from the science. A daunting task indeed.

Cross posted from Epicurean Ideal.

ADA, Dietitians, Corporate Sponsorship & HFCS

Some developments this year in the debate over high-fructose corn syrup: December 14, 2007: assistant editor at In These Times, Jacob Wheeler wrote an article called Corporate Potluck: Dietitians and their company sponsors make strange buffet fellows which highlighted the corporate industry partners attending the American Dietetic Association's 2007 Food and Nutrition Conference(FNCE). March 1, 2008: American Dietetic Association Welcomes The Coca-Cola Company as an ADA Partner. The press release says:

The program provides Partners a national platform via ADA events and programs with prominent access to key influencers, thought leaders and decision makers in the food and nutrition marketplace. About the time the dietitians were becoming critical of their own association, criticism was coming from the very influential and proficient author and renowned food policy advocate Marion Nestle. She quotes on her blog

Respected ADA colleagues: as long as your organization partners with makers of food and beverage products, its opinions about diet and health will never be believed independent (translation: based on science not politics) and neither will yours.

Furthermore, an interview with Amy Goodman of Democracy Now!, the author of The Omnivore's Dilemma: A Natural History or Four Meals and more recently In Defense of Food, An Eaters Manifesto, Micheal Pollan had this to say:

Well, nutrition science is very compromised by industry. Organizations like the American Dietetic Association take sponsorship from companies who are eager to find -- you know, be able to make health claims.

Soon the Corn Refiners Association launched a PR campaign that took Dietitians along with them with a full page ad in the Washington Post: "Registered Dietitians agree that HFCS is the same as table sugar and can be enjoyed in moderation."

This year at the American Dietetic Association Food and Nutrition Conference in Chicago, The Corn Refiners Association had an exhibit that included information about "the many ways corn based ingredients are contributing to great-tasting food and beverage choices and to innovations that enhance nutrition and help reduce calories and fat."

I guess the question is, who is supposed to be teaching who about nutrition?

Obesity Society's president protests menu labeling

Last month's second attempt by the New York City Board of Health to require menu labeling in chain restaurants with 15 or more locations is the subject of a suit by the New York Restaurant Association.

Okay- not surprising, you say. Of course a restaurant association would oppose the new rules--they stand to lose business if customers are actually aware of the number of calories in many of their popular menu items.

Except that the author of an affidavit in support of the restaurants' suit was filed by Dr. David B. Allison, the new president of the Obesity Society, an organization concerned with addressing obesity. The argument made by Dr. Allison is that customers may not actually reduce their calorie intake because of the information obtained via menu labeling. In fact, Allison says that they may actually increase their calorie intake with this knowledge--"by adding to the forbidden-fruit allure of high-calorie foods or by sending patrons away hungry enough that they will later gorge themselves even more," according to the NYTimes.

So if the concern is that the required menu labeling will not actually decrease business at the restaurants covered by the rules, why is the Restaurant Association suing to block the requirement? And why did they pay Dr. Allison to write the affidavit.

Obesity Society members have reacted in opposition to Allison's statement, releasing one of their own. According to the NYTimes, Allison's other industry ties have included advisory roles at Kraft, Coca-Cola and Frito-Lay.

Should FDA give waivers to panel members who have conflicts of interest?

Two recent analyses offer opposing views about whether the Food and Drug Administration (FDA) should give waivers to outside experts, allowing them to participate on important government panels despite conflicts of interest.

The Food and Drug Administration (FDA) relies on expert scientists as advisers on a host of panels, which strongly influence the agency's oversight of important issues ranging from food safety to the approval of new drugs and medical equipment. The advisers may have conflicts of interest, such as having received research funding from a company whose products are being reviewed by the panel. In some cases, FDA grants waivers to the rules prohibiting conflicts of interest, on grounds that the conflict is minor or that the adviser offers unique expertise that outweighs the concern about conflict.

Last spring, the FDA proposed new rules that would limit such waivers. According to a summary from the Center for Science in the Public Interest (CSPI): "Those guidelines would ban anyone with greater than $50,000 a year in financial ties to industry from advisory committees and deny a vote to anyone with lesser conflicts."

However, more recently FDA has emphasized the value it places on waivers, arguing that it would be difficult to replace the expertise of many advisers who have conflicts of interest. FDA cited a report (.pdf) from the Eastern Research Group, which reviewed a number of panels and argued that FDA might not be able to make do without the experts who received waivers (the report's first author, Nyssa Ackerley, is a former student of the food policy program here at the Friedman School).

By contrast, according to CSPI's Integrity in Science newsletter, a coalition of public interest groups including CSPI analyzed the same data and reached the opposite conclusion:

For each of the four advisory committees analyzed in the study, it would have taken a single FDA official just one week to replace all the advisers who had conflicts of interest with experts who do not have conflicts of interest, according to CSPI's analysis of the ERG data. Moreover, the FDA would be able to choose from nearly two potential unconflicted experts for every open slot. And, based on the same criteria for the expertise of potential committee members used in the study, these easily identifiable unconflicted experts would be more qualified than the ones eventually chosen, whether they had conflicts of interest or not.

Do you think FDA should grant waivers to conflict of interest rules to recruit expert panelists who would otherwise be ineligible? Comments are open.

NIEHS director steps aside temporarily

Dr. David Schwartz, the director of the federal government's institute overseeing environmental health issues, is stepping aside temporarily while senior officials review his embattled program, according to an Associated Press report (via Guardian Unlimited).

The National Institute of Environmental Health Sciences (NIEHS), part of the National Institutes of Health (NIH), addresses environmental toxins and their health consequences. The public health blog Effect Measure covers the controversy in full, including Schwartz's recent letter to staff announcing his stepping aside, an earlier controversy over his effort to outsource the institute's flagship journal Environmental Health Perspectives, Congressional inquiries into Schwartz's initiatives, and his effort to address conflict-of-interest rules he perceived as unwise and personally disadvantageous.

Economic influences on research in nutrition science

For many years, leading voices have been warning about conflicts of interest in nutrition science and the dietetics profession. One reads the work of Marion Nestle (.pdf) or, more recently, Catherine Woteki with considerable alarm.

The main rebuttal to these concerns has been that most nutrition and dietetics professionals are sufficiently honorable to tell the truth, without being influenced by their funding source. In this view, full disclosure and professional standards are sufficient to prevent conflicts from doing any harm. There is no need for further action or policies to limit conflicts of interest.

New empirical evidence shows that the funding source does appear to influence the conclusions of published scientific research in nutrition. This evidence appeared in a January article in PLoS, by Lenard Lesser, a young doctor and medical scholar now a resident Tufts. His coauthors are Cara Ebbeling, Merrill Goozner, David Wypij, and David S Ludwig.

A key table shows: (1) research conclusions were favorable to a food product in 64% of the 22 articles funded by industry sources who benefit from sales of that food product, (2) research conclusions were favorable to a food product in 46% of the 52 articles with no industry funding one way or the other, (3) research conclusions were favorable to a food product in 0% of the 2 articles funded by industry sources that compete with sales of a food product.

The conclusion:

Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors' products, with potentially significant implications for public health.