For many good food advocates, the end of a legislative session often means disappointment that their bills to help fix our broken food system did not pass. But in some states, when lawmakers go home we should really all breathe a big sigh of relief.
Such was the case last week when the Iowa Legislature adjourned without passing one of the more obnoxious proposals to rear its ugly head in any state house this year. In the wake of video footage exposing the horrific conditions of animals raised for our consumption, agribusiness decided it was time to fight back.
Iowa House File 589 would have made it a crime to “produce” an image or sound recording at an animal facility without permission from the owner. To ensure that media outlets also got the message, even possession and distribution of such recordings would have been outlawed.
For the first offense, you could be charged with an “aggravated misdemeanor” while a second offense could bring felony charges. And that was just under the section, “animal facility interference.” You could also be brought up on charges of animal facility fraud, crop operation tampering, crop operation interference, and crop operation fraud, each with its own mind-bending definition.
Earlier this year, Minnesota and Florida introduced similar bills. New York jumped into the fray in June, the last month of the legislative session there. The New York bill, titled without a hint of irony, “unlawful tampering with farm animals,” threatened punishment up to one year in jail or a $1,000 fine.
While these bills are particularly egregious, it’s not the first time that Big Agribusiness has attempted to silence its critics through a state-by-state attack on free speech rights. In fact, one of the first op-ed articles I ever published was on the “veggie libel laws” that were passed in the late 1990s. These statues, which were enacted in at least a dozen states, essentially turned speaking negatively about any food into a potential libel lawsuit. It was under one such statute in Texas that Oprah Winfrey was sued by six cattle feeder corporations for doing a show on the risks of mad cow disease in beef. (She won the case.)
That state-by-state lobbying effort was also led by powerful agriculture interests able to find friendly legislators to do their bidding. Another familiar theme is how the ag gag bills are so obviously a violation of the First Amendment. At least two constitutional law experts (both in Iowa) agree that these measures are unlikely to withstand a court challenge. But that hardly seems to matter.
What does matter is that the message is sent loud and clear to anyone who seeks to expose the unspeakable atrocities that animals suffer daily on factory farms: that engaging in such reporting will have serious consequences. It’s called chilling speech.
The good news is that so far, no ag gag bill has passed. While some animal advocacy groups have hailed the failure in all four states where bills were introduced, I wouldn’t recommend a victory party just yet. Procedurally, the bills were not voted down or vetoed by any governor. Rather, they each passed through their respective committees and died before coming to a full chamber vote. A positive sign for sure, but still no guarantee the threat is over.
For example, in Iowa, the bill passed the House but was left to die without a full vote in the Senate. According to an interviewwith Iowa Rep. Jim Lykam (who is opposed), as a two-year bill, the measure doesn’t even have to be reintroduced for the Legislature to vote on it again, come January 2012. And Republican Gov. Terry Branstad is already on record in favor of the idea.
The lead sponsor in Iowa was Republican Rep. Annette Sweeney, a cattle rancher and former executive director of the Iowa Angus Association. Also on record in support of the bill are the Iowa Cattlemen’s Association and the Iowa Poultry Association. Other Big Ag backers according to one account included “Monsanto, DuPont, and other mammoth agriculture corporations and trade associations.”
Such heavy hitters don’t let one minor setback get them down. Dave Murphy, founder and executive director of Food Democracy Now — an advocacy group based in Iowa — agrees we should not get complacent. “Iowans were fortunate this year. Intense opposition and media scrutiny helped kill it in the end. This victory, however, is temporary as proponents are promising to reintroduce the bill next year,” he said.
This is what agribusiness does best: keep up the lobbying pressure wherever they can. Indeed, signs indicate that these bills are part of a nationally coordinated effort. For example, the language of the Iowa and Minnesota bills bear a striking resemblance, suggesting a state-by-state attack strategy – just like the veggie libel laws. The language of those earlier bills was virtually identical.
The sponsor of the Minnesota bill is Rep. Rod Hamilton, past president of the Minnesota Pork Producers. And, apparently, the bill was aided by the Minnesota Agri-Growth Council, a powerful agricultural lobbying group. Dayrn McBeth, president of the organization, explained their strategy: “Neither we nor the authors expect to pass these bills. It was intended to start a conversation.”
Or maybe stop one?
Here’s what I wrote in 1998: “These laws are nothing more than an effort by big business to chill the free speech efforts by those seeking to raise legitimate questions about the safety of our nation’s food supply.” Just add “and concerns about animal welfare” and it’s déjà vu all over again.
“Big Ag’s Latest Attempt to Chill Free Speech” was originally published at Food Safety News on July 7, 2011. Republished with permission from Food Safety News. C Marler Clark and Michele Simon. All rights reserved.
PepsiCo Inc, after falling into third place in US soda sales, is putting new emphasis on its main product, Pepsi, planning to expand soda advertising by 30% this year. According to the Wall Street Journal, PepsiCo CEO Indra Nooyi is “facing doubts from investors and industry insiders concerned that her push into healthier brands has distracted the company from some core products.” Nooyi denies any change in overall strategy. “Good for you” products constitute only 20% of Pepsi’s revenues; the remainder comes from the high sugar, high salt “fun for you” products associated with obesity, diabetes and heart disease.
In two recent articles in the New York Review of Books, Marcia Angell, former editor of the New England Journal of Medicine, reviews several new books on psychiatry, mental illness and the pharmaceutical industry. In the first, she asks why there is an epidemic of mental illness and describes three books that show how the “profession has allied itself with, and is manipulated by, the pharmaceutical industry.” In the second, she describes another four volumes that examine the history of the pharmaceutical industry’s support for psychiatrists and its role in promoting unneeded or risky prescriptions for their products.
Late last year, the Center on Alcohol Marketing and Youth (CAMY) at the Johns Hopkins Bloomberg School of Public Health released its latest report on television alcohol marketing to youth. The new report shows that the average American youth sees one television ad for alcohol per day. While one a day is great for vitamins, it’s not a good prescription for young people being exposed to alcohol advertising. This is a significant and troubling escalation, and shows the ineffectiveness of the industry’s current voluntary standards. Here’s what our report found:
Youth exposure to alcohol advertising on U.S. television increased 71 percent between 2001 and 2009, more than the exposure of either adults ages 21 and above or young adults ages 21 to 34, according to the analysis from CAMY.
Driving this increase was the rise of distilled spirits advertising on cable television. Youth exposure to all distilled spirits TV advertising was 30 times larger in 2009 than in 2001, with significant growth occurring in distilled spirits ads on cable. By 2009, the majority of youth exposure to advertising for all alcoholic beverages on cable was occurring during programming that youth ages 12 to 20 were more likely to be watching than adults 21 and above.
Under pressure from the Federal Trade Commission to reduce youth exposure to alcohol marketing, in 2003 trade associations representing beer and distilled spirits companies joined wine marketers in committing to advertise only when the underage audience composition is less than 30 percent. This threshold has been ineffective in reducing youth exposure on television, either in absolute or in relative terms.
Using as the comparison 2004 (the first full calendar year after beer and distilled spirits adopted the 30 percent threshold), data show that by 2009 youth exposure to alcohol advertising on television had grown by a larger percentage than that of young adults ages 21 to 34 or adults ages 21 and above.
Moreover, industry compliance with the 30 percent threshold remained uneven. In 2009, 7.5 percent of all alcohol product ad placements (23,718 ads) and 9 percent of all alcohol product ad placements on cable (16,283 ads) were on programming with underage audiences larger than 30 percent.
CAMY commissioned Virtual Media Resources to analyze nearly 2.7 million product advertisements placed by alcohol companies from 2001 to 2009, purchased at an estimated cost of more than $8 billion. Key findings include:
The average annual number of alcohol ads seen by youth watching television increased from 217 in 2001 to 366 in 2009, approximately one alcohol ad per day.
In 2009, 13 percent of youth exposure came from advertising placed above the industry’s voluntary 30 percent threshold.
Also in 2009, 44 percent of youth exposure came from advertising that overexposed youth (i.e., was more likely to be seen per capita by youth ages 12 to 20 than by adults ages 21 and above) compared to persons of legal purchase age (21 and above).
On cable television, the majority of youth exposure came from advertising more likely to be seen by youth per capita than by adults ages 21 and above.
From 2004, when the distilled spirits and beer industries joined the wine industry in implementing a 30 percent standard to protect against youth exposure, to 2009, youth exposure to distilled spirits ads on cable television doubled.
In 2009, five cable networks were more likely to expose youth per capita to alcohol advertising than adults 21 and above: Comedy Central, BET, E!, FX and Spike. Two of these—Comedy Central and BET—delivered more exposure to youth than to young adults ages 21-34.
In 2009, 12 brands (8 percent) generated half of youth overexposure: Miller Lite, Coors Light, Captain Morgan Rums, Bud Light, Samuel Adams Boston Lager, Miller Genuine Draft Light Beer, Crown Royal Whiskey, Corona Extra Beer, Disaronno Originale Amaretto, Smirnoff Vodkas, Miller Chill and Labatt Blue Light Beer.
From 2001 to 2009, youth were 22 times more likely to see an alcohol product ad than an alcohol company-sponsored “responsibility” ad whose primary message warned against underage drinking and/or alcohol-impaired driving.
Background
Alcohol is the leading drug problem among youth [1] and is responsible for at least 4,600 deaths per year among persons under 21.[2] In 2009, 10.4 million (27.5 percent) young people in the U.S., ages 12 to 20, reported drinking in the past month, and 6.9 million (18.1 percent) reported binge drinking (defined as five or more drinks at one sitting, usually within two hours).[3] Binge drinkers consume more than 90 percent of the alcohol consumed by this age group.[4]
Every day in the U.S., 4,750 young people under age 16 have their first full drink of alcohol.[5] This is a problem because the earlier young people start drinking, the more likely they are to suffer alcohol-related health and social problems later in life. Compared to those who wait until they are 21 to drink, young people who start drinking before age 15 are four times more likely to become alcohol dependent,[6] seven times more likely to be in a motor vehicle crash because of drinking [7] and 11 times more likely to be in a physical fight after drinking.[8]
Exposure to alcohol advertising and marketing increases the likelihood that young people will start drinking, or that they will drink more if they are already consuming alcohol.[9] A wide range of studies has established the association between exposure to alcohol marketing and youth drinking behavior, even after controlling for a variety of variables such as parental monitoring or socioeconomic status.[10-16]
Alcohol industry spokespeople have stated that they observe a proportional standard when placing their advertising to ensure that young people are not overexposed.[17] Since 2003, industry-wide voluntary codes of good marketing practice have directed that alcohol advertisers avoid programming where underage audiences exceed 30 percent. However, the National Research Council and Institute of Medicine,[18] as well as 20 state attorneys general,[19] have suggested that a 15 percent standard, roughly proportionate to the percentage of the population between the ages of 12 and 20, would be more appropriate. In 2007, one company, Beam Global Spirits & Wine Inc., moved to a 25 percent standard, combined with a 15 percent annual aggregate average by brand and by medium. CAMY has estimated that, if adopted by the entire industry, this standard would reduce youth exposure to alcohol advertising on television by 14 percent and in magazines by more than 10 percent.[20]
Notes
Johnston LD, O’Malley PM, Bachman JG, Schulenberg JE. Monitoring the Future National Survey Results on Drug Use, 1975-2009. Volume I: Secondary School Students. Bethesda, MD: National Institute on Drug Abuse; 2010.
Centers for Disease Control and Prevention. Alcohol-Related Disease Impact Software. 2009: National Center for Injury Prevention and Control; available at: http://www.cdc.gov/alcohol/ardi.htm. Accessed June 27, 2010.
Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2009 National Survey on Drug Use and Health: Volume I. Summary of National Findings. 2010; Rockville, MD: Office of Applied Studies; available at: http://oas.samhsa.gov/NSDUH/2k9NSDUH/2k9Results.htm. Accessed October 20, 2010.
Pacific Institute for Research and Evaluation. Drinking in America: Myths, Realities, and Prevention Policy. Calverton, MD: prepared in support of the Office of Juvenile Justice and Delinquency Prevention Enforcing the Underage Drinking Laws Program, U.S. Department of Justice;2005.
Gfroerer J. Re: NSDUH figure. Personal communication (e-mail) to Jernigan D, Washington, D.C. Substance Abuse and Mental Health Services Administration, September 17, 2007.
Grant BF, Dawson D. Age of onset of alcohol use and its association with DSM-IV alcohol abuse and dependence: Results from the National Longitudinal Alcohol Epidemiologic Survey. Journal of Substance Abuse. 1997;9:103-110.
Hingson R, Heeren T, Jamanka T, Howland J. Age of Drinking Onset and Unintentional Injury Involvement After Drinking. Washington, D.C.: National Highway Traffic Safety Administration;2001.
Hingson R, Heeren T, Zakocs R. Age of drinking onset and involvement in physical fights. Pediatrics. 2001;108(4):872-877.
Anderson P, De Bruijn A, Angus K, Gordon R, Hastings G. Impact of alcohol advertising and media exposure on adolescent alcohol use: a systematic review of longitudinal studies. Alcohol and Alcoholism. 2009;44(3):229-243.
Collins RL, Ellickson PL, McCaffrey D, Hambarsoomians K. Early adolescent exposure to alcohol advertising and its relationship to underage drinking. Journal of Adolescent Health. Jun 2007;40(6):527-534.
Snyder L, Milici F, Slater M, Sun H, Strizhakova Y. Effects of alcohol exposure on youth drinking. Archives of pediatrics and adolescent medicine. 2006;160(1):18-24.
Stacy AW, Zogg JB, Unger JB, Dent CW. Exposure to televised alcohol ads and subsequent adolescent alcohol use. American Journal of Health Behavior. 2004;28(6):498-509.
Pasch KE, Komro KA, Perry CL, Hearst MO, Farbakhsh K. Outdoor alcohol advertising near schools: what does it advertise and how is it related to intentions and use of alcohol among young adolescents? Journal of Studies on Alcohol and Drugs. 2007;68(4):587-596.
Sargent JD, Wills TA, Stoolmiller M, Gibson J, Gibbons FX. Alcohol use in motion pictures and its relation with early-onset teen drinking. Journal of Studies on Alcohol. 2006;67(1):54-65.
McClure AC, Dal Cin S, Gibson J, Sargent JD. Ownership of alcohol-branded merchandise and initiation of teen drinking. American Journal of Preventive Medicine. 2006;30(4):277-283.
McClure AC, Stoolmiller M, Tanski SE, Worth KA, Sargent JD. Alcohol-branded merchandise and its association with drinking attitudes and outcomes in US adolescents. Arch Pediatr Adolesc Med. March 1, 2009 2009;163(3):211-217.
Becker J. Statement of Jeff Becker, President, The Beer Institute. U.S. Senate Committee on Health, Education, Labor and Pensions, Subcommittee on Substance Abuse and Mental Health Services. 108th ed. Washington, D.C.2003.
National Research Council and Institute of Medicine. Reducing Underage Drinking: A Collective Responsibility. Washington, D.C.: National Academies Press; 2004.
Rowe GS, Shurtleff ML, Goddard T, et al. RE: Alcohol Reports, Paperwork Comment, FTC File No. P064505. A Communication from the Chief Legal Officers of the Following States: Arizona, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Maine, Maryland, New Jersey, New Mexico, New York, Ohio, Oregon, Rhode Island, Utah, Vermont, Washington, Wyoming [California subsequently signed on]. 2006; available at: http://www.ftc.gov/os/comments/alcoholmanufacadstudy/522852-01287.pdf. Accessed December 6, 2006.
Center on Alcohol Marketing and Youth. Statement: Beam Global Sprits & Wine Principles: A Strong Step to Protect Our Kids. 2007; Washington, D.C.: Center on Alcohol Marketing and Youth; available at: http://www.camy.org/press/release.php?ReleaseID=39. Accessed 9 September, 2009.
Roberto Abadie is an anthropologist who has studied the experiences of people who get paid by pharmaceutical companies to take drugs in clinical trials. For the past two years, he has been a visiting scholar at the public health program at the Graduate Center of the City University of New York. His book, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects, was published by Duke University Press last year. Monica Gagnon interviewed Abadie by email for CHW. An edited transcript follows.
CHW: What inspired you to launch an investigation into the ethics of clinical trials?
RA: In 2001, Ellen Roche, an employee at Johns Hopkins University, volunteered in a clinical trial for asthma. She suffered an adverse event (as adverse drug reactions are usually referred to) fell into a coma, and died at a local hospital a month later. She had received a few hundred dollars for her participation in the trial that resulted in her death. I realized then that while bioethicists have been debating the ethics of paying volunteers participating in the first phase of clinical trials where drug safety is assessed, no empirical studies documenting the volunteers’ experiences and motivations to volunteer had been conducted. I was especially concerned about those volunteers who earn a living by selling their bodies to test drug safety. Some professional guinea pigs (as they refer to themselves) I met have done 80 or more trials in the course of a few years. I wanted to know how much they knew about the risks they face as trial subjects but also how the prospect of monetary compensation affects their perception and disposition to volunteer.
CHW: What challenges did you face during your research into Big Pharma? Did they attempt to shield their practices (or their human trial subjects) from you?
RA: Big Pharma is not a very open industry and they try very hard to shield information about their practices. Of course, they won’t say they don’t want the public to know. Their argument is that everything related to the drug production process is proprietary information. By being secretive they are protecting their products and their shareholders. It was very hard for me to gain access to the industry side. I wanted to ask them questions about how they deal with the issue of risk during the first phase of clinical trials and what they do to ensure that research subjects are adequately protected. Unfortunately, I didn’t manage to reach them. One of the public sources of information about Big Pharma’s practices regarding Phase I trials, or any aspect of drug development for that matter, are the lawsuits that are brought against them. For example, the Vioxx case went to court and its records provided a great deal of information about how the industry thinks about risks, public health and profits. Unfortunately, few cases go to court; most are settled out of court, leaving valuable information hidden from the public view. Professional healthy research subjects I met with feared retaliation from the industry if exposed, but anonymity protected them well.
CHW: How do the participants in the trials you studied now think about the pharmaceutical industry?
RA: I studied a very particular subgroup of the ample universe of subjects that earn a living as professional guinea pigs in America. I focused on a group of white, male anarchists living in Philadelphia, a hotbed of clinical trials activity. While all professional research subjects share similar interests (make money from participating in the trials) and experiences of dehumanization and alienation, this group of anarchist guinea pigs has particular strong views against Big Pharma and also, not surprisingly, about the role of the government and the FDA (the agency in charge of overseeing the drug production process). These volunteers feel that the industry lies, not only because they enroll volunteers when they know they don’t meet all their admission criteria, but more importantly, they lie to the consumers by producing drugs that are not safe and effective, as the industry claims.
But despite their hostility towards the industry, they feel the trials they participate in are in general only moderately risky. First, they reason, they are scientific, controlled experiments where there is a lot of oversight. Second, adverse events are very rare in their experience and most of them had not experienced them. And finally, they believe that ethical regulations and the fear of lawsuits are enough to deter the industry from bad practices.
CHW: How are the health risks of clinical trials underplayed by Big Pharma?
RA: I think that the most important risk overlooked by the industry is the risk derived from the fact that trials depend on a group of professional guinea pigs, paid to test drug safety. These subjects consider their trial participation to be their job, a particular kind of trade where boredom, pain and dehumanization are exchanged for money. They do seven or eight trials a year, deriving a total estimated income of $20,000 in a good year. The problem is that the industry does not have a registry that tracks trial participation and might not be aware of the extent of the professionalization.
My concern is that continuous participation in the trial economy might expose trial subjects to unknown or unforeseen risks, some of which might show up 20, 30 or even more years later. The industry is under a lot of pressure to recruit and retain trial subjects and has no incentive to create a registry or implement any measure that would limit their ability to recruit trial subjects for the first phase of clinical trials.
CHW: What are the economic forces that drive pharmaceutical companies to use risky test strategies?
RA: In particular, considering Phase I clinical trials where drugs are assessed for toxicity and not therapeutic benefit, Big Pharma depends on a group of professional subjects to run the trials smoothly. Until the 1970s, drugs were first tested on prisoners. Willing, compliant and readily available, they represented the perfect captive research subject. But ethical concerns brought the practice to a halt. The industry had to find a replacement population for an increasing number of trials and started paying prospective subjects. Some started volunteering and become dependent on the income and habituated to the trial routines.
Market recruitment of trial subjects created a new economic category: the professional guinea pig. It works well for poor, vulnerable research subjects because it provides a flexible schedule with reasonable pay, and it is great for the industry because it offers a steady supply of bodies to test drug safety quickly and effectively. The underside is that this professionalization might expose these workers to occupational risks, something that other workers in mining or agriculture have also experienced and where risks are better documented.
CHW: To what extent has the FDA addressed these problems? What has limited their effectiveness as a regulator of testing practices?
RA: The FDA only audits one percent of Phase I trials in America. And it is a paper trail kind of process, looking for protocol inconsistencies and especially missing cases where subjects unexpectedly are dropped from the research protocol. Of course they also pay attention to the reporting of adverse events. But this monitoring has severe limitations. First, they review a very small number of trials. Second, they never do on site inspections, going to the trial sites, looking at the working conditions, talking to research subjects, etc. Part of the explanation for this lack of enforcement is that the FDA does not have enough resources and manpower to do this kind of job.
But the main cause is that the FDA increasingly, since the 1980s, has taken the view that what is good for the pharmaceutical industry is good for the public and that speeding the drug development process would be a good thing because first, it would bring valuable drugs to consumers, but also would help American companies compete better in a global pharmaceutical landscape.
CHW: What is the crux of the relationship between risk and monetary compensation? Do you find that volunteers typically fully understand the risks of participating in these clinical trials?
RA: The research subjects I studied are well informed about risks but this does not mean that they make good decisions about whether they should enter a trial or not. For example, they know that psychotropic drug trials are risky and they try not to volunteer for them. But this is one of the fastest growing sectors in drug development and a big producer of blockbuster drugs for the industry. Big Pharma needs to test the safety of these drugs, and knows that subjects are reluctant to mess up their mind, as they have told me, taking them. What would the industry do then? Simple, they just offer the highest pay, from $5,000 to $10,000 for a few weeks as a trial subject. Most subjects I interviewed admitted that they thought these trials presented a high risk but were tempted by the money and had done at least one.
CHW: Do professional guinea pigs often rely on money from test trials as their primary income? If so, why is this particularly problematic?
RA: They do. For most of them, trials are their main, and in many cases only, source of income. They can earn around $20,000 a year and sometimes even more. I find this practice extremely problematic because Big Pharma uses money strategically to recruit and retain research subjects who otherwise would have no interest in participating in the trial economy. Research subjects are vulnerable because they depend on the income generated from the trial and that leads them to accept poor working conditions or risks they would not accept otherwise. Of course, the industry knows this and that’s why they use money to lure people and to keep them participating.
CHW: In what ways are the rights of human test subjects protected (or not)?
RA: Ethical regulations regarding the participation of human subjects in research have evolved a great deal since the horrors of the WWII. We have now a number of regulations that protect subjects like the requirement of informed consent before a subject enrolls in a trial. And civil law also affords protections against any wrongdoing or harm that occurs during the trial. Still, the consent form requirement is seen by professional guinea pigs as a formality, a paper to be signed among others in order to enter the trial. In most cases they make their decision about entering a trial before they get to sign the consent form. And legal recourse is expensive and might be out of reach for most subjects, unless they die or experience devastating adverse events, in which case the prospects of financial gain can lead skilled lawyers to volunteer in the case
CHW: Have you come across any particularly unique stories of people who have had negative (or positive) health effects from these trials? Please describe.
Roberto Abadie
RA: There are no positive health effects from healthy research subjects testing drug safety in the first phase of drug development. These tests are designed to assess the toxicity of a drug, not its efficacy and thus no health benefits are expected. Negative health effects or adverse events are rare. While most of the subjects I encountered had experienced some discomfort, fainting, nausea or other symptoms, they had not faced serious adverse events. In 2006, a trial sponsored by Parexel in England left research subjects with very serious injuries and opened a public debate about the professionalization of Phase I trial research in Europe and the need to create a centralized registry to track participants involvement in this trial economy.
CHW: How do you suggest that Big Pharma change its practices and policies regarding human subjects?
RA: Since there is no centralized record tracking the participation of research subjects in Phase I trials in America, nobody knows for example if a subject is doing two trials at the same time, or if a subject is not complying with the mandatory 30-day wash-out period in between trials. As I mentioned in the previous question, such a registry was recently implemented in Europe when it was found that trial subjects in drug safety trials were trial hopping, doing for example a trial in Ireland, then another one in England, one immediately after in Germany and a subsequent one in France. A centralized registry would prevent this from happening in the US as well. Such control would slow the recruitment rate of research subjects, delaying the completion of Phase I trials, and that’s why Big Pharma has been opposed to its implementation.
CHW: What are the broader public health implications of this practice of the pharmaceutical industry, and what can be done about it?
RA: The lack of a centralized registry tracking the participation of professional research subjects in Phase I trials endangers the research subjects because it exposes them to dangerous drug interactions. But it also challenges the validity of the trial itself because its findings become compromised if researchers cannot tell with certainty that their results are not contaminated by a different drug that is being surreptitiously taken by the research subject, enrolled simultaneously in two different trials. This is a very serious development because it compromises the quality and efficacy of drugs millions of people depend on for their health care.
The lack of a centralized registry, but also of adequate FDA control regarding the first phase of clinical trials speeds up drug production and contributes to making Big Pharma one of the most profitable industries in America. But increasingly we find new evidence that the pharmaceutical industry’s continuous search for profits and public health interests are not on the same page. We need to step up the oversight on this industry, from government, of course, but also from citizens and consumer groups. In particular, journalistic exposes have contributed to documenting outrageous cases of abuse and exploitation of research subjects in Phase I trials, like the case of undocumented Latino immigrants being recruited in a facility in Florida a few years ago, or poor, African-American homeless men with alcohol and drug related issues recruited at a site in the Midwest. Such cases, when exposed through the press, generate a public relations nightmare for these companies. When they are touched in their pocket books, these companies have shown they can do the right thing.
In response to the new warning labels on cigarette packs proposed last week by the US Food and Drug Administration, Dan Jaffe, the Association of National Advertisers’ exec VP for government relations, told Ad Age that the ANA thinks the proposal is unconstitutional because “the government on its own … can’t put words in the mouths of advertisers.” The second, third and fourth largest tobacco companies in the United States, Reynolds American Inc, Lorillard Inc. and Commonwealth Brands are part of a federal lawsuit that challenges the legality of the new labels. Also joining the opposition is the National Association of Convenience Stores, a group representing an industry that interacts with 160 million Americans a day. “You’re going to run into people that will not necessarily like this,” said Jeff Lenard, an NACS spokesman. “When somebody’s hungry, they get something to eat. When somebody’s thirsty, they get something to drink, and we just want to make sure that when they go in, they still want to get that.”
Jack in the Box has eliminated toys from children’s meals, winning the approval of consumer advocates who claim fast food corporations use the toys to attract kids to unhealthy meals. “We hope that McDonald’s, Burger King, Wendy’s, and Taco Bell are paying attention to Jack in the Box, which has decided to stop using toys to market fast-food meals to children,” the Center for Science in the Public Interest said in a statement. “It’s too bad that McDonald’s, Burger King, Wendy’s, and Taco Bell think they can’t compete on the basis of quality, value, taste, or nutrition, but instead must resort to such a discredited marketing tactic to lure families to their businesses.” However, Ad Age notes that Jack in the Box rarely markets to kids and is a fraction of the size of McDonald’s.
In an in depth report in a recent issue of the American Scholar, Harriet Washington, author of Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present, describes how the pharmaceutical industry uses doctors, medical organizations and medical journals to promote its products.
Note: This post is a longer version of a correspondence that appeared in Lancet on August 13, 2011.
Alarmed that non-communicable diseases (NCDs), the world’s number one killer, now pose a growing threat to economic development, this September the United Nations General Assembly will convene its first High Level Meeting on NCDs in New York City. World leaders and public health officials will consider how to reduce the growing threat that cardiovascular disease, cancer, chronic respiratory disease and diabetes pose to population health, economic development and health care systems.
Non-Communicable Disease Alliance Briefing Paper for UN Meeting on NCDs
These conditions cause an estimated 35 million deaths annually; 80% occur in low and middle income countries and one quarter among people younger than 60 years of age. By 2030, NCDs will cause more than three quarters of all deaths in the world.
In preparation for the UN meeting, groups as varied as the NCD Alliance, a coalition of four global voluntary health organizations, the Commonwealth Heads of Government and theMillennium Development Goal Summithave proposed important but uncontroversial actions such as improving surveillance for NCDs, integrating NCD prevention and control into national health systems, making NCD prevention an economic development issue, and allocating more international assistance for NCDs.
The NCD Alliance has also recommended more controversial steps such as ratification and full and universal implementation of the WHO’s Framework Convention on Tobacco Control and the elimination of “all forms of marketing, particularly those aimed at children, for foods high in saturated fats, trans-fats, salt and refined sugars.” The most pressing question facing the UN meeting is whether participants will be willing to tackle the corporate practices of the tobacco, food, alcohol, automobile and pharmaceutical industries that have so significantly contributed to the global spread of NCDs.
How Corporations Promote the Spread of NCDs
A growing body of evidence demonstrates that how corporations create, market, retail and price their products has contributed to increases in NCDs. For example, food and beverage makers market products high in fat, sugar, salt and calories; increase portion size; target children with ads and video games promoting unhealthy food; lobby for policies that make unhealthy foods cheaper than healthier ones and export their least healthy products such as sugar-sweetened beverages, fast food, cereals and snack foods to low and middle income countries. The result has been rising rates of diet-related NCDs.
The alcohol industry advertises aggressively to young and problem drinkers, contributing to liver diseases as well as injuries and violence. The industry uses its political clout to stop excise taxes that would discourage youth and problem drinking and sponsors ineffective “responsible drinking” campaigns that compete with under-funded effective approaches and emphasize individual rather than social responsibility for discouraging problem drinking. The automobile industry produces cars that fail to use available pollution control technology, opposes stricter standards for pollution control, and resists policies that favor cleaner public transportation. Increasing evidence links auto pollution with chronic respiratory disease, heart diseases and cancer.
Tobacco is predicted to contribute to one billion premature deaths in this century. The tobacco industry manipulates nicotine levels to make cigarettes more addictive and promotes its products, especially to women and young people in developing countries, their emerging markets. By increasing the rate of women’s smoking through targeted advertising, the tobacco industry has helped to shrink the longevity benefit that women have long enjoyed over men, a perverse way of reducing inequities.
Finally, while the pharmaceutical industry has developed drugs that have helped to control NCDs, it also promotes inadequately tested or dangerous drugs to treat NCDs and invests in developing minor variations of patented drugs that are profitable rather than in cheaper, safer and more effective alternatives.
While NCDs have multiple causes, a growing body of evidence shows that their burden on global health are inextricably linked to the practices of a small number of global companies in industries that are becoming increasingly concentrated. Ten multinational food companies account for 80% of the global food and beverage advertising. The three largest tobacco companies sell close to two-thirds of the world’s cigarettes and a few companies produce most of alcohol the world drinks. Thus, altering the practices and policies of a few dozen corporations could substantially improve the prospects for preventing and managing NCDs but this requires political leaders to demand changes in some of the world’s most powerful corporations.
Making Corporations Accountable
To date, the business world has been remarkably successful in avoiding responsibility for its role in NCDs. It does this by exploiting or manufacturing several myths about chronic disease. First, many people see NCDs as the inevitable consequence of economic development and population aging, the collateral damage of progress. But many people now develop NCDs in early and mid-adult years, so their rapid growth is not simply a function of aging populations. China, Egypt, Jamaica and Sri Lanka have NCD mortality profiles similar to the US and other developed nations, contradicting the view that NCDs are the unique curse of better off countries. Business benefits from portraying NCDs as the unavoidable corollary of aging and development because this view spares closer scrutiny of the role of corporate practices.
Second, conventional wisdom posits lifestyle as the primary cause of NCDs: if only people ate better, moved more, smoked less and consumed less alcohol, the world could prevent many deaths and lower the costs imposed by NCDs. As a result, NCD prevention focuses on programs designed to change health-related behavior, often one person at a time. Of course individuals’ health behavior contributes to NCDs. However, no evidence demonstrates that the world’s population has recently become more gluttonous or susceptible to addiction. What has changed is the behavior of the organizations that shape the environments in which people make health decisions. Global expenditures for advertising increased from $50 billion in 1950 to $570 billion in 2005. In the last few years the number of corporate lobbyists working in the capitals of the United States, the United Kingdom, the European Union and wherever international trade negotiations occur has skyrocketed, giving business a disproportionate voice in the policy decisions that shape health and lifestyle.
Corporations and their political supporters insist that business has an important role in shaping NCD policies and promote a third myth that voluntary corporate codes are the most effective tool for changing their health-damaging practices. Last summer, UK Health Secretary Andrew Lansley invited Mars, Cadbury and Coca Cola to play greater roles in the national anti-obesity initiative and the development of new food regulations. Corporate health leaders at Pepsi Cola and other companies have called for more private-public partnerships to address NCDs. However, their claim that voluntary agreements for corporate social responsibility suffice to protect public health is not supported by independent assessments of such codes in the food, alcohol and tobacco industries.
Calls for public sector collaboration with businesses fail to acknowledge that many companies profit from promoting NCDs. Corporate managers are legally required to maximize profits and too often depend on business models that exploit biological vulnerabilities (e.g., a craving for high fat, sugar and salt diets), addictions, or social insecurities. Some companies may temporarily benefit from selling healthier food or promoting more responsible drinking but in the long run increasing consumption and market share usually require promoting disease rather than health.
In the final analysis, if the UN meeting is to make progress in stopping the rise in NCDs, participants will need to find the backbone to stand up to corporate propaganda and lobbyists. Specific policies that could put a dent in the incidence of NCDs include: tighter restrictions on advertising unhealthy products; laws and taxes that discourage companies from transferring or externalizing the health costs of their products onto consumers or tax payers; legal corporate codes of conduct that require global companies to disclose known health effects of their products and practices; and stronger restrictions corporate lobbying and campaign contributions in order to provide health advocates with a more level political playing field. Absent forceful political mobilization by social movements, local governments and health professionals and their organizations, it is unlikely that businesses will agree to such a platform but will instead argue for the incremental, ineffective approaches they have advanced so far. Stay tuned for further developments.
For Further Reading
Beaglehole R, Bonita R, Horton R, et al. Priority actions for the non-communicable disease crisis. Lancet. 2011;377(9775):1438-47.
Cecchini M, Sassi F, Lauer JA, Lee YY, Guajardo-Barron V, Chisholm D. Tackling of unhealthy diets, physical inactivity, and obesity: health effects and cost-effectiveness. Lancet 2010;376 (9754):1775-84.
Freudenberg N, Galea S. The impact of corporate practices on health: implications for health policy. J Public Health Policy. 2008;29(1):86-104.
Geneau R, Stuckler D, Stachenko S, et al. Raising the priority of preventing chronic diseases: a political process. Lancet. 2010;376(9753):1689-98.
Monteiro CA, Levy RB, Claro RM, de Castro IR, Cannon G. Increasing consumption of ultra-processed foods and likely impact on human health: evidence from Brazil. Public Health Nutr. 2011;14(1):5-13.
World Health Organization. 2008-2013 Action Plan for the Global Strategy for the Prevention and Control of Noncommunicable Diseases, 2008.
Fast food and soda companies are attempting to make their products seem sleeker and healthier, according to a series of articles in Advertising Age.
McDonald’s, Burger King and Subway are all building redesigned stores, aiming to look more like restaurants and cafes than fast food joints. Meanwhile, PepsiCo is planning to lauch a mid-calorie beverage called “Pepsi Next.” The new drink is likely going to be marketed as a reduced sugar beverage, and the goal is for it to taste better to some consumers than diet soda. According to John Sicher, editor and publisher of Beverage Digest, “This is an attempt by Pepsi to come up with another tool to keep consumers in their cola franchise.”
Iowa House File 589 would have made it a crime to “produce” an image or sound recording at an animal facility without permission from the owner. To ensure that media outlets also got the message, even possession and distribution of such recordings would have been outlawed.
Corporations and Health Watch 