Off-label marketing: Good for business, bad for health

Posted on by Corporations and Health Watch

Off-label marketing has been illegal since 1938 but continues despite major lawsuits because expanding market share leads to hefty industry profits. And now, a last minute Bush administration policy push inside the FDA may be giving this practice of off-label marketing the official thumbs up.

Pharmaceutical companies are spending big bucks to settle suits for illegally promoting drugs for off-label uses and harming customers in the process. The practice, called off-label marketing, has been illegal since 1938 but continues because expanding market share leads to hefty industry profits. And now, a last minute Bush administration policy push inside the FDA may be giving this practice of off-label marketing the official thumbs up.

Most recently, Eli Lilly, the maker of Zyprexa, pled guilty to off-label marketing in a federal suit settled in January and has been ordered to pay a $1.4 billion settlement—the largest in Department of Justice history.1 The FDA approved the use of Zyprexa (olanzapine), for treatment for schizophrenia and bipolar illnesses in 1996 but the drug has been used off-label for generalized anxiety disorder, panic disorder, post-traumatic stress disorder, conduct disorders in children and dementia among elderly patients.

After the ruling, Laurie Magid, the Department of Justice acting attorney in the case, severely criticized the industry for endangering consumer health and ignoring federal law by marketing drugs for off-label uses. In a Philadelphia Inquirer op-ed Magid said, “These cases should send a clear message to the entire pharmaceutical industry: This conduct must stop.”2

Industry profits eclipse potential fines?

In the past five years, almost all major pharmaceutical companies have been involved in lawsuits for off-label marketing offenses, resulting in over $6 billion in settlements.3 Industry documents disclosed in these cases show companies knowingly promoted off-label uses for drugs that had unknown or undisclosed health effects for the express purpose of increasing market share and boosting sales.

Neurontin (gabapentin), an adjunctive antiepileptic made by Warner-Lambert (now part of Pfizer), was marketed off-label for epilepsy monotherapy (for use by itself), as a treatment for migraines, bipolar disorder, restless leg syndrome and attention-deficit/hyperactivity disorder (ADHD). That case settled for $430 million.4 Actiq (fentanyl), a painkiller 80 times more potent than morphine made by Cephalon, was approved by the FDA to treat cancer-related pain but was marketed off-label as a general pain reliever.5 Zyprexa, an antipsychotic approved to treat schizophrenia and some events related to bipolar I mania, was illegally marked. In each example, companies marketed their products for more common conditions than those approved by the FDA. And in each case, patients taking these medications for off-label uses experienced significantly more adverse health events, including death, than those taking the drugs for approved uses. All three companies have pleaded guilty to their charges, and the settlement monies are headed to consumer and state restitution funds and whistleblower compensation.

Unfortunately, however, settlement fines seem scarcely enough to successfully curb the practice of off-label marketing when compared to industry profitability. In 2007, the pharmaceutical industry was the nation’s third most profitable industry out of all Fortune 500 firms, with drug sales over $286.5 billion.6 When Lilly’s Zyprexa was leading company sales, the drug brought in over $1 billion per quarter,7 vastly exceeding the recent settlement fine ($1.4B). Today, the company’s total annual revenue is more than $20 billion.

Why off-label marketing is off limits

Much like direct-to-consumer (DTC) advertising, off-label marketing influences prescribing habits which, in turn, drives drug utilization and sales. DTC ads on TV or in magazines are only allowed to promote on-label uses of drugs and are subject to FDA penalties if guidelines are not met. However, off-label marketing, which targets doctors, is illegal because use of a drug for any indication other than the one on the (FDA approved) label carries unknown risks.

Historically, the FDA has served to protect consumers against those risks. Banning the marketing of drugs for unapproved uses was an issue of consumer protection when first addressed as a federal concern. Since 1938, when the Food Drug and Cosmetics Act established new rules for drug makers, off-label marketing was recognized as a serious threat to consumer health. Sulphanilamide, an elixir marketed for the treatment of infection, was the catalyst for this Act. Having never been tested, and containing what is now recognizable as anti-freeze, the “elixir” killed more than 100 people, most of them children, before being taken off the market. Public outrage led to the establishment of what was to become the defining feature of drug regulation: safety and effectiveness as determined by the independent, peer-reviewed clinical trial.8 Theoretically, FDA approval of a medication is granted for specific use(s) and it is for those uses only that the drug can be marketed.

Side effects

Ten years after being on the market, Zyprexa was given a black box warning that states, “Not approved for the treatment of patients with dementia-related psychosis.” Independent studies revealed these patients have almost two times the risk of death compared to those taking a placebo (non-theraputic control drug).9 But the company had already made a global marketing blitz, advertising the drug as a good treatment for dementia-related symptoms. Their “five at five” campaign championed 5 milligrams at 5 PM to subdue disruptive elderly patients with dementia.

Zyprexa also causes weight gain and diabetes, side effects that are particularly pronounced in children and youth. According to the drug’s label, more than half of people taking Zyprexa as a long-tem treatment gain 12 or more pounds. Additionally, “safety and effectiveness in pediatric patients have not been established.” Despite the warnings, the dramatic increase in the number of antipsychotic prescriptions written between 1996 and 2005 was due, one study found, to a “remarkable increase in the rates of use for off-label conditions and use among youth.”10 The authors singled out “drug company marketing effects” and the “dominance of industry-funded trials” as two potential sources for the profusion of antipsychotic prescriptions.

Beyond drug safety; health spending and ‘manufactured’ evidence

To be clear, off-label prescribing is both legal and common—it is off-label marketing that is illegal. Doctors can prescribe any medication they believe will be helpful as long as that drug is FDA approved. Radley et al. reported in the Archives of Internal Medicine that according to a large nationwide sample of prescriber reports collected in 2001, 21% of all prescriptions were for off-label uses.11

Many argue off-label drug prescription is necessary in situations where clinical trials have not included vulnerable populations, for example children and elderly adults, due to ethical guidelines. So off-label prescribing is not necessarily a bad idea, but it does carry extra known and unknown health risks and costs to health care.

There are other concerns about off-label marketing. First, blockbuster drug sales driven by marketing campaigns contribute to skyrocketing health care spending. Prescription drug costs account for $1 out of every $10 spent on health care in the U.S. and that number is expected to increase rapidly over the next 10 years, in part due to rising drug utilization rates.6 In 2007, 3.8 billion prescriptions were filled, up 72% since 1997.6 The U.S. spends $792 per capita on pharmaceuticals, more than all other OECD countries, and nearly twice the OECD median.12 One might expect this kind of spending to translate in to real health benefits, but U.S. health status, as measured by WHO indicators, only slipped further behind developed nations since 1997 with the highest mortality from causes considered amenable to health care.12

Second, conflicts of interest between drug researchers, the pharmaceutical industry and the FDA, leave consumers vulnerable to untested, scientifically unsound medical practices, the health care system to pay for the billions of dollars spent on medications used for off label purposes, and treatments for their untoward side effects. In an interview with McClatchy Newspapers, Arthur Caplan, Professor of Bioethics, University of Pennsylvania called it a “fox in the hen house situation.”13 The research available to doctors regarding off-label drug treatments is heavily biased by pharmaceutical industry interests—one recent study found 73% of medications prescribed for off-label use had “little or no scientific support.”11 Additionally, FDA drug advisory panels that make recommendations about which drugs should be approved are populated with drug company consultants who have financial ties to the drugs reviewed. In a report published in JAMA in 2006, Public Citizen’s Health Research Group found conflicts of interest occurred in 73% of advisory meetings in 2001-2004.14

As Marcia Angell, former editor of The New England Journal of Medicine and author of The Truth About Drug Companies, recently wrote, “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines.”15

Marketing matters—expanding the target audience

When a drug’s specific indication is narrow and therefore appropriate for a relatively small group of patients, pharmaceutical companies can expand potential user groups and boost sales legally by adding new indicators that have been demonstrated to respond favorably to this medication, using scientifically valid testing procedures. This approach, however, requires FDA approval. As the recent court cases reveal, many drug companies chose to sidestep regulatory authorities and expand their drug’s market share by off-label marketing to doctors.

src=”uploads/images/old_archives/img/Cocktailofdrugs.png” alt=”Cocktailofdrugs” hspace=”10″ vspace=”5″ width=”250″ height=”167″ align=”right” />Blockbuster sales of a product approved for a very limited audience is less likely a measure of drug efficacy than the outcome of powerful marketing campaigns directed at doctors. Whether a medication’s use is expanded legally with FDA approval (as GlaxoSmithKline did with Paxil when its use was extended from treatment of depression to social anxiety disorder), or illegally with off-label marketing (as was the case with Neurontin, Actic, Zyprexa and many others), the result is more people receiving a prescription and consequently sales soar. In the words of Barry Brand, Paxil’s product director at GlaxoSmithKline, “Every marketer’s dream is to find an unidentified or unknown market and develop it.”16

For example, in the case of Zyprexa, indicated uses (for schizophrenia and some bipolar symptoms) occur relatively rarely—between 1-3% of the general population. But when the company began marketing the drug as a treatment for other off-label symptoms, the potential market share was greatly expanded. Documents used as evidence in a Zyprexa court case indicate this was the result of a targeted off-label marketing agenda. In a company meeting, Zyprexa brand manager Mike Bandick said the company “intends, quite simply, to redefine the way [primary care physicians] treat mood, thought, and behavioral disturbances.”17 Eli Lilly’s efforts to convince prescribers that Zyprexa was a good treatment for dementia (and several other disorders) launched the drug into a top selling position—with a total of $39 billion in sales since it hit the market.18

FDA industry ‘Guidance Doc,’ new cause for worry

Before a solution to the above concerns can take shape, there is a new monkey wrench in the off-label drug promotion conflict. In January, during the last days of the Bush administration, policy makers at the FDA issued a ‘Guidance Document’ for the pharmaceutical industry.19 Despite recent court rulings, the document appears to give pharmaceutical companies the thumbs-up to market “unapproved new uses” for FDA approved drugs to doctors. In other words, drug sales reps have the legal ‘ok’ to send prescribers medical articles their company has funded, directly benefiting from the evidence they have produced.

Several health and consumer groups strongly criticized an earlier draft of this FDA guidance. In a 2008 statement,20 the Patient and Consumer Coalition, comprising such organizations as Center for Science in the Public Interest, Consumers Union, National Physician’s Alliance, Our Bodies Ourselves, the Prescription Project and others, asserted that it “strongly opposes this draft guidance, which would allow the promotion of off-label use of prescription drugs and medical devices by giving manufacturers the right to distribute reprints of poorly regulated journal articles with minimal federal oversight.” In the Coalition’s view, “the draft guidance is much too lenient, has no enforcement tools, undermines the Food and Drug Administration’s prohibition on off-label marketing, and lowers incentives for drug and device makers to complete clinical trials or seek FDA approval for new uses.”

Proposed solutions

As the FDA comes under new leadership, several solutions to the problem of off-label marketing warrant consideration.

  1. Enforce existing federal laws and drop the exceptionalism in the new ‘Guidance Document.’ As U.S. Attorney Magid from the Zyprexa case wrote, “Off-label marketing is a sales strategy that ignores the basic purpose of the federal drug-regulatory program, which is to protect the consumer… Off-label-marketing cases are not easy to bring. They can take years and involve the review of millions of documents by an alphabet soup of federal agencies, state regulators, and law-enforcement officers. But we will keep bringing them until this practice stops.”2
  2. Pass new laws that require full disclosure of all drug company payments to physicians. Senators Grassley (R-IA) and Kohl (D-WI) have introduced “The Physician Payments Sunshine Act” that would require pharmaceutical companies to report all marketing and payments to doctors to the Department of Health and Human Services. With increased attention to the need for corporate transparency under the Obama administration and a Democrat led Senate, the bill may have a chance to pass this year.
  3. Provide new incentives and penalties to encourage physicians to report off-label promotional campaigns. Fugh-Berman and Melnick suggest increasing fines, increased marketing regulations and more culpability for physicians. “Perhaps financial incentives could be provided to reward physicians and others who report off-label promotions,” the authors suggest.

 

References

1 Pharmaceutical company Eli Lilly to pay record $1.415 billion for off-label drug marketing. U.S. Department of Justice. Jan 15, 2009. Available at: http://www.usdoj.gov/usao/pae/News/Pr/2009/jan/lillyrelease.pdf

2 Magid L. Keeping us safe from drug reps. The Philadelphia Inquirer. Jan. 27, 2009. Available at:http://www.philly.com/inquirer/opinion/20090127_
Keeping_us_safe_from_drug_reps.html

3 Adams C. Bush admin opened door to controversial off-label marketing of drugs. McClatchy-Tribune News. Feb 1, 2009. Available at: http://bulletin.aarp.org/yourhealth/policy/articles/bush_administration
_opened_door_to_controversial_offlabel_marketing_of_drugs.html

4 Warner-Lambert to pay $430 million to resolve criminal and civil health care liability relating to off-label promotion. U.S. Department of Justice. May 13, 2004. Available at: http://www.usdoj.gov/opa/pr/2004/May/04_civ_322.htm

5 Attorney General Announces $6.15 Million Settlement For Illegal Drug Marketing. Connecticut Attorney General’s Office. September 29, 2008. Available at: http://www.ct.gov/ag/cwp/view.asp?a=2795&q=423868

6 Prescription Drug Trends – Fact Sheet. Kaiser Family Foundation. Sept 2008.

7 Ackerman R. Eli Lilly’s Zyprexa sales are depressing. Forbes. April 21, 2008. Available at:http://www.forbes.com/2008/04/21/elililly-pharma-diabetes-markets-equity-cx_ra_0421markets10.html

8 Goozner M. The $800 Million Pill: The Truth behind the Cost of New Drugs. University of California Press; 2004.

9 Patient information sheet: Olanzapine (marketed at Zyprexa). FDA Center for Drug Evaluation and Research. Sept 2006. Available at: http://www.fda.gov/cder/drug/InfoSheets/patient/olanzapinePIS.htm

10 Domino ME, Swartz MS. Who Are the New Users of Antipsychotic Medications? Psychiatric Services. 2008;59(5):507–14.

11 Radley DC, Finkelstein SN, Stafford RS. Off-label Prescribing Among Office-Based Physicians. Arch Intern Med. 2006;166:1021-1026.

12 Towards a High Performing Health Care System: An International Perspective. The Commonwealth Fund. Presentation by Robin Osborn. October 20, 2008.

13 Adams C. Late move on drugs by Bush FDA could be dangerous. McClatchy-Tribune News. Feb 1, 2009. Available at:http://www.mcclatchydc.com/244/story/61113.html

14 Lurie P, Almeida C, Stine N, Stine A, Wolfe S. Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings. JAMA. 2006;295:1921-1928.

15 Mossakowski KN. Is the duration of poverty and unemployment a risk factor for heavy drinking? Soc Sci Med. 2008;67(6):947-55.

16 Vedantam S. Drug Ads Hyping Anxiety Make Some Uneasy. Washington Post. July 16, 2001; Page A01. Available at:http://vedantam.com/socialanxiety07-2001.html

17 Zyprexa Primary Care Presentation. Eli Lilly National Sales Meeting. Mar 13, 2001. Available at:http://www.furiousseasons.com/zyprexa%20documents/
ZY100041630.pdf

18 Levine B. The Case for Giving Eli Lilly the Corporate Death Penalty. AlterNet. March 3, 2009. Available at:http://www.alternet.org/workplace/129709/eli_lilly_and_the
_case_for_a_corporate_death_penalty/

19 Good reprint practices for the distribution of medical journal articles or medical scientific reference publications on unapproved new uses of approved drugs and approved or cleared medical devices. Department of Health and Human Services. Food and Drug Administration. Office of the Commissioner. Jan 2009. Available at:http://www.fda.gov/oc/op/goodreprint.html

20 Comments of the Patient and Consumer Coalition to the U.S. Food and Drug Administration “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices DRAFT GUIDANCE Docket No. FDA-2008-D-0053.” April 18, 2008. Available at: http://www.cspinet.org/new/pdf/20080421_group_comments_on_fda_off-label_draft_guidelines.doc

21 Fugh-Berman A, Melnick D. Off-label promotion, on-target sales. PLoS Med. 2008;5(10):e210.

 

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New York State’s Tax on Sugar-Sweetened Beverages Goes Down the Drain: Lessons for Nutrition Advocates

Posted on by Corporations and Health Watch

The soda tax came and went this year in New York. Here, CHW examines the campaign to pass a sugar-sweetened beverage tax, the likely factors that led to its failure, and also offers important lessons for future efforts.

On December 15, 2008, media sources revealed elements of New York State Governor Paterson’s proposal for the 2009-2010 state budget. Among the many new fees and fines that the Governor proposed in order to close the estimated $15 billion deficit was an 18% sales tax on sugar-sweetened beverages. With the new fiscal year less than four months away, the announcement of this tax spurred advocates and opponents to quickly mobilize constituents, engage the media, and lobby state legislators. Less than three months later, on March 11, 2009, state legislative leaders announced that the sugar-sweetened beverage tax would not be included in the final budget. This report examines the campaign to pass a New York State sugar-sweetened beverage tax and the likely factors that led to its failure. This analysis also offers several important lessons for future efforts in public health advocacy designed to make unhealthy food less available.

A Dual Crisis in New York State

At the end of 2008, two major problems were occurring in New York State. The first was a growing obesity epidemic. In the past decade, adult obesity in New York State has nearly doubled, and currently about two-thirds are overweight or obese.1 The weights of children and adolescents have also increased during this time; the most recent data show that one-third of New York State Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) participants and more than one-quarter of state high school students are overweight or obese.2,3 Black, Latino, and low-income New Yorkers experience disproportionately high rates of obesity, diabetes, and other diet-related diseases, increasing the already large health inequalities among these groups. In all, obesity-related illnesses are estimated to cost the state more than $6 billion annually.4

With this steady rise in obesity, per capita consumption of sugar-sweetened beverages has also increased during this time. Although we cannot say definitively that drinking soft drinks and other “liquid candy” causes obesity, studies consistently show that the more soda we drink, the more calories we consume and the higher our body mass index (BMI),5 a measure of obesity. With such a growing and significant contributor of calories for many Americans, nutritionists and public health professionals have stressed the importance of reducing sugar-sweetened beverage consumption to prevent and decrease obesity and other diet-related health conditions.

By the end of 2008, New York State was facing a second problem—a large and rapidly growing state budget deficit. In the midst of a global economic crisis, New York was experiencing a triple loss: declining personal income tax revenue from lost jobs and bonuses, decreasing corporate income tax revenue from disappearing business profits, and waning sales tax revenue as shoppers limited their spending. Estimated at $6.4 billion in July 2008, the budget deficit more than doubled to $15 billion by the end of the year.6,7 As a result, the state needed to rein in spending and find revenue alternatives through new fees, fines, and taxes.

In order to tackle these two issues simultaneously, Governor Patterson introduced what was quickly nicknamed by the media as the ‘obesity tax.’ The two goals of the proposed 18% sales tax on sugar-sweetened beverages were to raise an estimated $404 million in the first year, while at the same time creating a cost differential that was expected to convince shoppers to instead buy the cheaper low, or no-calorie alternatives, thus helping to curb weight gain and obesity.

The Campaign to Pass a New York State Tax on Sugar-Sweetened Beverages

During the three months after the tax was announced, state and local children’s advocacy groups and public health organizations—particularly the American Academy of Pediatrics, Citizens’ Committee for Children, New York Academy of Medicine, New York City Department of Health and Mental Hygiene, New York State Department of Health, New York State Healthy Eating and Physical Activity Alliance, New York State Public Health Association, and the Public Health Association of New York City—targeted state legislators by employing the following strategies:

  1. Media advocacy
      via press releases, letters to the editor, and op-eds

    Constituent mobilization

      through the use of e-mail action alerts, in-person and online education, and a memo of support

    Direct lobbying

      by providing testimony at budget hearings, mailing information packets, and visiting key legislators

However, the campaign faced multiple barriers, including a politically weak and wavering Governor and a growing economic crisis that did not provide a receptive public climate for tax increases. In addition, the campaign had a strong and united group of opponents who were also targeting state legislators. A coalition called New Yorkers Against Unfair Taxes emerged, including more than 80 national, state, and local business and citizen groups, most notably the Business Council of New York State; National Restaurant Association; New York State Restaurant Association; Grocery Manufacturers Association; Bodega Association of the United States; Coca-Cola Bottling Company of Buffalo, Inc.; and Pepsi Cola Bottling Newburgh; among many others.

Although not part of this coalition, another vocal opponent was the American Beverage Association, the trade association representing companies that manufacture and distribute non-alcoholic beverages in the United States—the very products that would be taxed under the Governor’s proposal. Between 2006-2008, these groups collectively spent more than $4 million to gain political influence in New York State via campaign contributions and lobbying.8

Despite the campaign’s use of multiple strategies, Governor Patterson—in agreement with legislative leaders after several days of closed-door meetings—announced on March 11, 2009 that the sugar-sweetened beverage tax would not be included in the final budget. Advocates attribute the failed policy to two key factors. The first was the Governor’s public statement of doubt at a town hall meeting. The New York Times quoted him as saying, “The tax on soda was really a public policy argument. In other words, it’s not something that we necessarily thought we would get. But we just wanted the population to know some issues about childhood obesity.”9 Once this hit the newsstands and airways, advocates felt that the sugar-sweetened beverage tax was dead. Secondly, campaign members believe that the tax was doomed from the start because of how it was introduced by the Governor’s office. Several advocates noted that rather than singling out the sugar-sweetened beverage tax and focusing on its public health benefits, it was instead lumped in with a list of other fees referred to by opponents, the media, and even some legislative leaders as regressive or nuisance taxes.

Even though the campaign was not successful in achieving the tax increase on sugar-sweetened beverages, advocates believe that they were effective in constituent mobilization. Still, more could have been done to engage those outside of the public health and child advocacy groups. Comparatively, New Yorkers Against Unfair Taxes created a website, blog, cell phone texting service, online petition, and Facebook profile that together spread their opposing message to thousands of people. Advocates made no equivalent use of new media technologies or social networking strategies. Most legislators heard more from opponents than supporters.

One organization, Citizens Committee for Children (CCC), a multi-issue child advocacy group, initially proposed an excise tax on sugar-sweetened beverages rather than a sales tax. They made the case that an excise tax would be levied on bottlers and distributors rather than consumers and would result in a higher price for large volumes, thus serving as a more effective deterrent for high consumption. The excise tax would also have generated significantly more revenues for the state and CCC proposed that a portion of these revenues be dedicated to nutrition education or obesity prevention. Statewide polling data showed support for this approach.10 The Governor rejected the idea of an excise tax, in part because it would take additional months to establish a system for collecting the revenues, whereas sales tax revenues could be collected immediately. When the Governor’s office rejected this approach, CCC backed the sales tax proposal but some advocates continued to believe that the excise tax strategy was a more effective public health and economic approach.

Finally, many nutrition advocates had mixed feelings about the sugar-sweetened beverage tax. Supporters acknowledged that it would financially burden the poor most, although they argued it would also benefit them most by helping to reduce disparities in obesity rates. Opponents of the soda tax claimed that making healthy food more available in poor communities was a moral and public health imperative. Some supporters replied that in the absence of reducing the availability of unhealthy food, it would be difficult to lower obesity rates. One compromise proposed by advocates is to use revenues from a sugar-sweetened beverage tax to subsidize the purchase of healthy foods, thus counteracting any regressive effects the tax might have.11

Lessons for Round Two

Even if public health campaigns are not able to fulfill their main policy goals, they can still successfully mobilize constituencies and contribute to public debate. One of the key lessons for advocates is the need for a strong policy introduction and legislative champion. In this case, the tax may have been more successful if it was introduced on its own, rather than with other unpopular fees and fines, though this may not be true for all policy proposals. Additionally, policies need to be framed with messages that invoke values such as social justice, rather than getting bogged down with the details. By using value-based messages from the very beginning, advocates may be more likely to create and maintain a supportive policy framework and overcome statements made by opponents and the media. And as indicated by several advocates, the sugar-sweetened beverage tax was effectively viewed as dead after the Governor publicly stated that he didn’t think it would be approved. With a stronger legislative champion willing to stand by the tax until the end, the outcome may have been different.

This campaign also illustrates the importance of context in affecting outcomes. Advocates must understand the historical, social, and political environments in order to identify windows of opportunity, frame messages appropriately, and utilize effective strategies. In this case, imposing a new tax in the midst of an economic crisis was bound to be unpopular for many residents. The campaign tried to define the issue more broadly by linking the tax to improved health and lower healthcare costs, though this still did not involve enough stakeholders and diverse groups to pass the tax. Perhaps early messages that countered the campaign’s opponents, such as disclosing the beverage industry’s behind-the-scenes lobbying tactics and targeted marketing strategies, may have helped change the public discourse surrounding the tax.

In the same vein, advocates of public health measures probably fare better if they are united in their support for a proposal and if they have resolved moral or other ambiguities prior to public debate. The lack of prior internal dialogue among advocates on the value and limits of taxes on unhealthy food and the short interval available for mobilization may have handicapped their ability to bring clear and consistent messages into the policy arena.

Finally, it is important to remember that it may take two or more attempts to pass legislation, especially when there is little precedent for the policy. Not knowing in advance opponents’ strategies and messages, this first attempt at a sugar-sweetened beverage tax in New York State was actually a valuable learning experience. Campaigns should evaluate their efforts and those of their opponents in order to increase the likelihood of future success. Measures of outputs and outcomes should include surveys of constituents, policymakers, and the media.

 

References

1 Centers for Disease Control and Prevention. BRFSS Prevalence and Trends Data: New York, 2007. Available at: http://apps.nccd.cdc.gov/BRFSS/display.asp?cat=OB&yr=2007&qkey=4409&state=NY. Accessed March 20, 2009.

2 Edmunds LS, Woelfel ML, Dennison BA, et al. Overweight trends among children enrolled in the New York State Special Supplemental Nutrition Program for Women, Infants, and Children. J Am Diet Assoc. 2006;106(1):113-117.

3 Centers for Disease Control and Prevention. YRBSS Youth Online: Comprehensive Results. Available at: http://apps.nccd.cdc.gov/yrbss/SelQuestyear.asp?cat=5&desc=Dietary%20Behaviors&loc=NY. Accessed March 30, 2009.

4 Office of the State Comptroller. Preventing and reducing childhood obesity in New York. October, 2008. Available at: http://www.osc.state.ny.us/reports/health/childhoodobesity.pdf. Accessed March 30, 2009.

5 Vartanian LR, Schwartz MB, Brownell KD. Effects of drink consumption on nutrition and health: a systematic review and meta-analysis. Am J Public Health. 2007;97(4):667-675.

6 Hakim D. Governor calls for session on fiscal crisis. NY Times. July 30, 2008. Available at: http://www.nytimes.com/2008/07/30/nyregion/30paterson.html?ref=nyregion. Accessed March 31, 2009.

7 Fiore M. Studies weigh in on logic behind ‘obesity’ tax. Fox News. December 17, 2008. Available at: http://www.foxnews.com/story/0,2933,468245,00.html. Accessed March 16, 2009.

8 Deep pocketed sugar sweetened beverage tax opponents spend over $4 million to influence public health policy [press release]. New York: New York State Health Eating and Physical Activity Alliance; March 12, 2009.

9 Confessore N. Paterson lowers expectations on soda tax, calling approval unlikely. NY Times. February 14, 2009. Available at: http://www.nytimes.com/2009/02/14/nyregion/14sodatax.html?_r=1&scp=3&sq=soda%20tax&st=cse. Accessed March 9, 2009.

10 Citizens’ Committee for Children of New York, Inc. Voter preferences for closing the New York State budget gap. December 12, 2008. Available at: http://www.cccnewyork.org/publications/12-12-08CCCPoll.pdf. Accessed March 13, 2009.

11 Brownell KD, Frieden TR. Ounces of prevention—the public policy case for taxes on sugared beverages. N Engl J Med. 2009;360:1805-1808.

 

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News Updates: New Reports on the Alcohol, Tobacco and Firearms Industries

Posted on by Corporations and Health Watch

The gun industry’s role in trafficking weapons to Mexico, the FDA set to regulate tobacco, and the new venues of alcohol advertising: the influence of corporations on population health is all over the news! Check out highlights from three new reports that focus on regulation.

ALCOHOL

Out-of-Home Alcohol Advertising: A 21st: Century Guide to Effective Regulation

Downdload the PDF

This report, by the Marin Institute (March 2009), the alcohol policy advocacy center, provides advocates and policymakers with suggestions for designing effective regulation of alcohol advertising at the state and local levels. With an eye on emerging trends in out-of-home advertising (e.g., digital billboards, advertising in public transit), this 12-page report focuses on the strengths and weaknesses of laws on the books in various jurisdictions across the U.S. It summarizes the factors advocates should consider when designing effective oversight of alcohol advertisements. With examples of restrictions likely and unlikely to withstand legal challenge and examples of model language from current laws on the books in cities in California and Pennsylvania, this report can help those interested in achieving effective regulation of alcohol advertising in their communities.


TOBACCO

The Family Smoking Prevention and Tobacco Control Act

On April 2nd, the House of Representatives passed H.R. 1256, the Family Smoking Prevention and Tobacco Control Act by a vote of 298 to 112. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the FDA authority to regulate the manufacturing, marketing and sale of tobacco products. The bill adds a new chapter to the FFDCA to regulate tobacco products. Tobacco products would not be regulated under the “safe and effective” standard currently used for other products under the agency’s purview, but under a new standard—”appropriate for the protection of the public health.” With the support of President Obama, Senator Edward Kennedy is expected to soon introduce a version of the house bill in the Senate. Two tobacco-state senators, Richard Burr, a Republican, and Kay Hagan, a Democrat, both from North Carolina, have submitted a weaker substitute bill that would create a new tobacco regulatory agency within the Department of Health and Human Services. As the New York Times noted in an April 25th editorial, “such a fledgling agency would almost certainly be much less effective than the F.D.A., especially since the senators don’t propose to grant it the broad powers and ample resources provided by the House-passed bill.”

Key features of the House of Representatives-passed bill include:

  1. Restrictions on marketing and sales to youth
  2. Specific authority granted to FDA to restrict tobacco marketing
  3. Detailed disclosure required of ingredients, nicotine and harmful smoke constituents
  4. FDA allowed to require changes to tobacco products to protect the public health
  5. Strictly regulated “reduced harm” products
  6. Requirement for bigger, better health warnings
  7. FDA activity funding through a user fee on manufacturers of cigarettes, cigarette tobacco and smokeless tobacco, allocated by market share

For a special report on the Family Smoking Prevention and Tobacco Control Act from the Campaign for Tobacco Free Kids, go to: http://www.tobaccofreekids.org/reports/fda/summary.shtml.


GUNS

Exporting Gun Violence: How Our Weak Gun Laws Arm Criminals in Mexico and America

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The Brady Center to Prevent Gun Violence has issued a new report on the problem recently reported in the New York Times (“Loopholes to let gun smuggling to Mexico flourish,” April 14, 2009) entitled, “Exporting Gun Violence: How Our Weak Gun Laws Arm Criminals in Mexico and America.” Arguing that same laws that allow gun trafficking into Mexico have long allowed trafficking of guns to American criminals, the Brady campaign supports new laws that make background checks mandatory for all gun purchases and beefing up the authority of the Bureau of Alcohol, Tobacco and Firearms (ATF) to enforce laws.

In the report, the Brady Campaign urges U.S. leaders to look further than just enforcement of existing laws, and strengthen American gun laws to make it harder for Mexican criminals to arm themselves with U.S. firearms. The report stresses the urgent need for stronger gun laws that make it more difficult for military-style assault weapons and other guns to be sold by American gun dealers to gun traffickers who take guns over the border into Mexico, supplying weapons to fuel the violent drug cartels.

Is McDonald’s Lovin’ the Economic Crisis? Hard times, fast food and health

Posted on by Corporations and Health Watch

Despite the slumping economy, tightening credit market, rising food prices and growing concern about obesity, 2008 was a very good year for the McDonald’s Corporation, the world’s largest fast food company. By the end of the year, Mickey D’s hadposted 55 consecutive months of increases in global same–store sales; operated a record 32,000 restaurants in 100 countries and increased the value of shares by 6% and revenues by 7%. Its return on equity, a measure of a firm’s efficiency in generating profits, was 29%, nearly triple the industry average of 10% and the company increased its dividend by 33%. These increases,said the company’s CEO Jim Skinner, show that we are delivering what customers count on from McDonald’s—choice, variety and high–quality food and beverages at affordable prices.

In this report, Corporations and Health Watch examines how McDonald’s has responded to the economic crisis and considers the health implications of recent changes in its corporate practices. The larger goal is to identify new opportunities for public heath advocates to advance their health agenda in a changing economic and political climate.

Only a few years ago, McDonald’s faced some daunting challenges, recently summarized in the New York Times. A rapid pace of expansion had led to declines in service and quality as McDonald’s was unable to hire and train staff quickly enough. In addition, a bevy of critics made McDonald’s a target. In 1999, a crowd of French protesters led by slow food activist Jose Bove dismantled a McDonald’s outlet just days before it was due to open, loaded the rubble onto trucks and tractors, drove it through town and dumped it outside the town hall, winning approval from many French eaters. Eric Schlosser’s 2001 best seller Fast Food Nation revealed the company’s sleazy employment, food safety and environmental practices. Two years later McDonald’s experienced its first quarterly loss ever and its stock dropped sharply. In 2004, Morgan Spurlock’s documentary Super Size Mewarned millions of consumers about the health dangers of the Happy Meal diet.

In 2004, McDonald’s hired a new CEO, Jim Skinner, a long time company manager who had started his career flipping burgers, to revitalize the company’s fortunes. His actions helped to turn the company around. In part in response to declining sales, McDonald’s sold off some recent acquisitions. In 2007, it sold Boston Market, a US chain that is a leader in the fast–casual restaurant category, and a year earlier it had dropped its investment in Chipotle Mexican Grill. Also in 2007, the company sold most of its businesses in Latin America to a developmental licensee organization. In 2008, McDonald’s sold its interest in the British–based Pret–A–Manger, a global company that bills itself as a healthy alternative to fast–food outlets. These divestitures helped McDonald’s to refocus on its core business.

Another change was that McDonald’s learned to rapidly modify its menu in response to economic changes. In the current economic downturn, for example, McDonald’s has emphasized value rather than nutrition. Its 2008 US profits came from increased sales on breakfast biscuits (729 calories, 49 gms fat, without syrup or margarine), Southern style chicken sandwiches (419 calories, 19 gms fat) and drinks. The Dollar Menu is an example of a promotion to encourage customers concerned about price to walk through the Golden Arches anyway. As the company website explains, the Dollar Menu provides you with quality menu items at a good value… We understand how important it is to you—especially these days. That’s why you can depend on us to give you value across our entire menu.

In contrast, a year ago, in better times and a more prosperous place, McDonald’s succeeded in increasing market share in Europe by going upscale. In 2007, the company spent more than $828 million to renovate its European outlets, adding healthier items, catering to regional tastes and adding features such as Internet access and rental I Pods. Sales rose 15%. By the end of that year, the chain was serving 10 million customers a day in Europe, contributing 36% to the companies operating income.

Increasingly, McDonald’s depended on other countries for growth and profits. In 2007, revenues in Europe topped those in the United States. Growth was also strong in Asia, the Middle East and Africa. 
In November 2008, for example, just as the economic crisis was spreading, McDonald’s global sales increased 171% more than its US sales. As Mickey D’s brought its signature products to Europe, Asia and the Middle East, it also sought to accommodate local tastes, a process some have labeled glocalization. In India, for example, it took beef off some menus to accommodate Hindus who don’t eat it.

McDonald’s also changed its marketing, responding to critics more forcefully and using more innovative strategies. For example, its Quality Correspondents program, seeks to win over mothers by taking them on tours of its kitchens, highlighting food quality and healthful options. This cadre of volunteer sales moms can enhance the company’s image and help overcome the single largest barrier to more McD’s sales to children: mothers’ health concerns.

In 2006, McDonald’s introduced a campaign to create gyms in its restaurants, adding exercise bikes, basketball hoops and climbing structures. Its ad campaigns featured svelte, active urban parents and children—their idealized patrons, rather than the more typical customers who were often overweight and struggling to make ends meet. While an editorial in PR Weekcongratulated the company for its emphasis on healthy living, critics charged that the focus on physical activity, like the company’s philanthropic contributions to school fitness programs, served to distract public attention from the company’s role in the obesity epidemic.

McDonald’s has also agreed to take voluntary steps to modify its products to improve their nutritional quality. In 2006, under the auspices of the Council of Better Business Bureaus (CBBB) and the National Advertising Review Council (NARC), McD’s joined 9 other major food companies to increase the percentage of healthy foods in advertisements targeting children younger than 12; change the product mix in ads targeted at children, stop advertising their products in elementary schools and stop deals for product placement in TV shows and movies. In 2008, with Burger King and KFC, McDonald’s promised the British Food Standards Agency, to cut the levels of fat and salt in their products and to serve more salad.

At the same time, the company took on its critics more forcefully. Fictititous information irresponsibly published and reported in the media has people questioning the quality and safety of fast food in general, said CEO Skinner. In 2006, according to the Wall Street Journal, McDonald’s hired a public relations firm to counter Eric Schlosser’s charges against the company.

By 2008, these changes—and a declining economy—had helped to turn the company around. The growing sales and healthy profits led financial analysts to be bullish on Mickey D. Goldman Sachs analyst Steven Kron told investors that recent growth in sales and profits temper lingering concerns that a global economic slowdown will impact the company’s results. CEO Skinner said, Worldwide turbulence is barely affecting our business. We are growing worldwide, especially in Europe we have significant gains.

New Vulnerabilities

Despite the optimism on Wall Street and at corporate headquarters, McDonald’s does face some vulnerabilities. Although McDonald’s may be better able to weather the credit squeeze than smaller chains, some analysts see clouds on the horizon. The company plans to build McCafes, specialty coffee bars in its 14,000 US locations, at a cost of $100,000 each. Jonathan Kaufman, chair of McDonald’s national advertising committee, told investors that lenders will definitely be looking at your ratios, your cash flow, your profit and loss, which they always did, but I know they’re going to take a harder look. What will change absolutely is interest rates. To date, 6,500 of the US outlets have installed McCafes. If the remaining franchises have trouble getting credit, they might not be able to join what the company hopes will be a promising profit center that can draw in new customers.

Another threat is the gyrating commodity prices. In the first part of 2008, global food prices rose sharply and in July 2008, McDonald’s warned investors that rising chicken and beef prices might reduce profits. Increases in beef and cheese prices recently led McDonald’s to take the double cheeseburger (468 calories, 26 gms of fat and 1137 mg of sodium) off the Dollar Menu, advising franchises to price it at $1.19. To make up for the loss, the company added a new McDouble Burger made with two all–beef patties and a single slice of cheese—one less than in the chain’s traditional double cheeseburger. This change will save McDonald’s six cents a burger and spare eaters some calories, fat and sodium. In the longer term, rising demand for beef and chicken in emerging markets in Asia, Latin America and elsewhere is likely to lead to further price increases, making it difficult for fast food companies to keep prices down and cost conscious customers in.

And while globalization has contributed to McDonald’s profits, it also raises some risks. In the last decade, Mickey D has become a symbol for the United States and as US power and prestige have declined, that identification can present problems. At a recent demonstration against the Israeli attack on Gaza held in Malaysia, reports Al Jazeera, former Prime Minister Mahatir Mohamed urged those working for McDonald’s and other US companies to quit their jobs. In October 2008, the Venezuelan government of Hugo Chavez ordered more than one hundred McDonald’s restaurants to close down for 48 hours because of alleged tax irregularities. Whether a new adminsitation in Washington will make the US and its products less of a target remains to be seen.

Globalization also offers critics of McDonald’s opportunities to learn from each other and devise global strategies to counter the company. Now that Mickey D has agreed to hold the salt in its British outlets, it can be expected that health advocates and officials in the US and elsewhere will make similar demands. Evidence shows that the salt in processed food is a major contributor to cardiovascular and other diseases.

At a recent meeting of the International Task Force on Obesity in Sydney, Australia, several public health organizations proposed the Sydney Principles to spell out what governments need to do to reverse the epidemics of obesity and diabetes. (See Box 1). With their focus on protecting children from deceptive or manipulative advertising, strong regulation and global standards, these principles could be seen as a threat by McDonald’s and other global chains. Should pressure build for an international treaty to give these principles the force of law, marketing opportunities for children could be constrained, threatening profitability and the important task of recruiting lifetime customers for Happy Meals.

Box 1

The Sydney Principles

    1. SUPPORT THE RIGHTS OF CHILDREN.
      Regulations need to align with and support the United Nations Convention on the Rights of the Child and the Rome Declaration on World Food Security which endorse the rights of children to adequate, safe and nutritious food.

    1. AFFORD SUBSTANTIAL PROTECTION TO CHILDREN.
      Children are particularly vulnerable to commercial exploitation, and regulations need to be sufficiently powerful to provide them with a high level of protection. Child protection is the responsibility of every section of society – parents, governments, civil society, and the private sector.

    1. BE STATUTORY IN NATURE.
      Only legally–enforceable regulations have sufficient authority to ensure a high level of protection for children from targeted marketing and the negative impact that this has on their diets. Industry self–regulation is not designed to achieve this goal.

    1. TAKE A WIDE DEFINITION OF COMMERCIAL PROMOTIONS.
      Regulations need to encompass all types of commercial targeting of children (e.g. television advertising, print, sponsorships, competitions, loyalty schemes, product placements, relationship marketing, Internet) and be sufficiently flexible to include new marketing methods as they develop.

    1. GUARANTEE COMMERCIAL–FREE CHILDHOOD SETTINGS.
      Regulations need to ensure that childhood settings such as schools, child care, and early childhood education facilities are free from commercial promotions that specifically target children.

    1. INCLUDE CROSS BORDER MEDIA.
      International agreements need to regulate cross–border media such as Internet, satellite and cable television, and free–to–air television broadcast from neighbouring countries.

  1. BE EVALUATED, MONITORED AND ENFORCED.
    The regulations need to be evaluated to ensure the expected effects are achieved, independently monitored to ensure compliance, and fully enforced.

Source: http://www.iotf.org/sydneyprinciples/#TheSydney

More broadly, the tension between globalization, a single brand identity with a relatively homogenous international market, and glocalization, a segmented and diversified market, also presents challenges. Each approach demands a different business model and different marketing strategies. Whether Mickey D’s can straddle that divide remains to be seen. AsNaomi Klein and global justice advocates point out, the power of a global brand is also its Achilles heel. On the other hand, the risk of one hundred local variants is that the global company loses its competitive edge and the potential for economies of scale. In either choice, McDonald’s greatest vulnerability is its image and both global and local strategies offer critics and food advocates tempting targets including health, the environment, labor practices, animal rights, and the company’s disproportionate political influence.

Impact on Health

In the coming years, how McDonald’s responds to the changing economy could set new standards for the fast food industry and therefore for global health. In the worst case scenario, Mickey D and other fast food companies continue to search for the cheapest foods, emphasizing the lower cost and higher profit calorie dense and nutrient poor processed foods at the expense of fruits, vegetables and healthier options. In addition, in this scenario, these companies continue heavy and aggressive marketing, using a mix of low prices and sometimes deceptive health claims to entice customers with stretched budgets and few other options for eating out. As more people fall into poverty, cheap calories will become more attractive, leading to growing rates of obesity and greater disparities in obesity and diabetes between the better off and the poor.

Some nutritionists worry that a continuing recession could worsen this trend, contributing to obesity. In a recent interview, Adam Drewnowski, the director of the Nutrition Sciences Program at the University of Washington in Seattle told Reuters that consumers are going to economize and as they save money on food they will be eating more empty calories or foods high in sugar, saturated fats and refined grains, which are cheaper. He noted that obesity is a toxic result of a failing economic environment and that studies in California suggested that a 10 percent rise in poverty translates into about a 6 percent increase in obesity among adults. Eileen Kennedy, Dean of the Friedman School of Nutrition Science and Policy at Tufts Universityexplained, the reality is that when you are income constrained the first area you try to address is having enough calories in your diet. And cheap sources of calories tend to be high in total fats and sugars. Thus, the McDonald’s Dollar Menu offers consumers the dubious bargain of might saving money at the expense of their waistline and health.

On the international front, continued pressure from developed nations to improve their business practices could lead McDonald’s and other companies to move even more aggressively to capture markets in India, China and elsewhere, visiting American–style epidemics of obesity and diabetes on these nations as well.

A more optimistic scenario is that McDonald’s and other fast food companies, governments and local, national and global public health organizations could agree on new ground rules that would require companies to consider the health impact of their practices and reject strategies that were good for business but bad for health. Preliminary assessments of compliance with voluntary agreements do not provide much grounds for optimism. A 2006 review of McDonald’s compliance with its voluntary agreements to restrict marketing to children commissioned by the World Health Organization found thatindustry’s voluntary efforts to self–regulate are inadequate. Our case studies support this conclusion. McDonald’s continues to emphasize marketing of its core products to children. The authors concluded food companies cannot resolve the childhood obesity dilemma on their own. For business reasons alone, they cannot—and will not—stop making and marketing nutritionally questionable food products to children.

This report suggests that the economic crisis has helped McDonald’s to attract new customers with inexpensive products high in calories, fat, sodium and salt; to extend its global reach; and to avoid the criticisms leveled by nutritional and environmental critics. While McDonald’s is by no means the worst offender on these fronts, its size and market share make it an important force and a global pace setter. By developing new ground rules for corporate behavior and new responsibilities for governments to protect health, food advocates can help to prevent the current economic crisis from exacerbating global health crises.

 

Nicholas Freudenberg is Distinguished Professor of Public Health at Hunter College and Founder and Director ofCorporations and Health Watch.

 

Posted January, 2009

Photo Credits:
1. afagen
2. haynes
3. jburgin 

Check out CHW’s profile on McDonald’s from November, 2007, McDonald’s and Children’s Health: The Production of New Customers, and visit the Corporations and Health Watch archives for interviews, profiles, and news on industry influence in science and health.


 

Films on Corporate Practices and Health

Posted on by Corporations and Health Watch

Feature Films

 Too Big to Fail (2011). This feature film maps the 2008 financial crisis with Treasury Secretary Henry Paulson as protagonist.

Fast Food Nation (2006). This fictionalized version of the book by the same title looks at the impact of fast food and corporate control over food production on health, society and the environment.

The Constant Gardener (2005) Based on the John Le Carre novel by the same title, The Constant Gardener explores how pharmaceutical companies knowingly test dangerous AIDs drugs on populations of developing countries.

Side Effects (2005). A film about a young pharmaceutical rep who is torn between earning a good living and living a good life.

Thank You for Smoking (2005). A satirical look at the practices of the tobacco, alcohol and gun industries and their impact on health.

The Runaway Jury (2003). Based on a John Grisham thriller about the tobacco industry’s efforts to manipulate juries, the film switches to the gun industry’s role in avoiding liability damages.

A Civil Action (1998). A slick lawyer takes on two giant chemical companies for their pollution of a town’s water.

Class Action (1991). Courtroom drama in which father and daughter represent opposite sides in a suit against a negligent auto company.

 

Documentaries

Fed Up (2014). An examination of how the food industry contributes to America’s obesity epidemic

Food Chains (2014). A look at food workers in America and the challenges they face at the hand of corporations- in this case, supermarkets.

Inside Job (2011). Feature-length documentary about the 2008 financial crisis

Corporate Fascism: The Destruction of America’s Middle Class (2010). How do corporates impact our political system?

Food Inc. (2008). An eye-opening look at how corporations control the food industry

Forks Over Knives (2008). Investigates how the major diseases of our time- chronic diseases related to lifestyle, can be combatted by a diet that rejects processed and animal-based foods.

Poultrygeist (2007) “Poultrygeist” is a satirical look at the fast food industry, examining what happens when “American Chicken Bunker,” a military-themed fried-chicken chain, builds a restaurant on the site of an ancient Indian burial ground. The film was written by a fast-food employee, produced with the support of PETA, and shot almost entirely through volunteer effort.

Bad Seed: the Truth about our Food (2006). An examination of the hidden costs of genetic engineering of food told through the perspectives of farmers, victims of genetically-engineered products, leading scientists, food safety advocates and more.

Big Bucks, Big Pharma: Marketing Disease & Pushing Drugs. This documentary examines how pharmaceutical companies profit through the creation, definition, and redefintion of disease, direct marketing of pharmaceutical products to consumers, and the increasing medicalization of mental and physical health.

The Future of Food (2004) Looking at the effects of genetic engineering in Mexico, the United States and Canada, this film explores the health impact of genetically engineered food and the dangers of increased corporate control over the food system.

Supersize me (2004) Filmmaker Morgan Spurlock examines the impact of fast food consumption by eating nothing but McDonalds food for 30 days and by looking at the impact of the fast food industry on health and society.

The Corporation (2003) Using case studies, this documentary examines corporations through a psychological lens, argues that corporations fit the criteria for psychopathy, and highlights the dangers that corporate practices can have on the environment and society.

Deadly Deception (1991). This academy-award winning documentary bringing to light the side effects caused by the General Electric Company’s production of nuclear materials.

 

Have a film you think should be added to our list?
Email us at info@corporationsandhealth.org

Selected references on automobile industry practices and health

Posted on by Corporations and Health Watch

This month CHW continues its series on selected references from the peer-reviewed scientific literature with a listing of 47 references on the health impact of automobile industry practices.

Corporations and Health Watch is conducting a search for articles that assess the impact of corporate practices on health for various industries. This list includes selected publications from the peer-reviewed literature that describe and analyze the marketing, product design, retail and pricing practices of the automobile industry.

Arbesman M, Pellerito JM Jr. Evidence-based perspective on the effect of automobile-related modifications on the driving ability, performance, and safety of older adults. Am J Occup Ther. 2008;62(2):173-86.

Arbogast KB, Durbin DR, Kallan MJ, Winston FK. Effect of vehicle type on the performance of second generation air bags for child occupants. Annu Proc Assoc Adv Automot Med. 2003;47:85- 99.

Ballesteros MF, Dischinger PC, Langenberg P. Pedestrian injuries and vehicle type in Maryland, 1995-1999. Accident Analysis and Prevention. 2004;36:73-81.

Bedard M, Guyatt GH, Stones MJ, Hirdes JP. The independent contribution of driver, crash, and vehicle characteristics to driver fatalities. Accident Analysis and Prevention. 2002;34:717-727.

Buckeridge DL, Glazier R, Harvey BJ, Escobar M, Amrhein C, Frank J. Effect of motor vehicle emissions on respiratory health in an urban area. Environ Health Perspect. 2002;110(3):293-300.

Cohen MJ A social problems framework for the critical appraisal of automobility and sustainable systems innovation .Mobilities 2006; 1(1): 23-38.

Crandall CS, Olson LM, Sklar DP. Mortality reduction with air bag and seat belt use in head-on passenger car collisions.American Journal of Epidemiology. 2001;153:219-224.

Daly L, Kallan MJ, Arbogast KB, Durbin DR. Risk of injury to child passengers in sport utility vehicles. Pediatrics. 2006;117:9-14.

Duvall T, Englander F, Englander V, Hodson TJ, Marpet M. Ethical and economic issues in the use of zero-emission vehicles as a component of an air-pollution mitigation strategy. Sci Eng Ethics. 2002;8(4):561-78

Farmer C. Effect of electronic stability control on automobile crash risk. Traffic Inj Prev. 2004;5(4):317-25.

Farmer CM, Braver ER, Mitter EL. Two-vehicle side impact crashes: The relationship of vehicle and crash characteristics to injury severity. Accident Analysis and Prevention. 1997;29:399-406.

Farmer CM, Lund AK. Trends over time in the risk of driver death: what if vehicle designs had not improved? Traffic Inj Prev. 2006;7(4):335-42.

Ferguson SA. The effectiveness of electronic stability control in reducing real-world crashes: a literature review. Traffic Inj Prev. 2007;8(4):329-38.

Ferguson, S.A., Hardy, A.P., Williams, A.F. (2003). Content analysis of television advertising for cars and minivans: 1983-1998. Accident Analysis and Prevention, 35:825-831.

Ferguson SA, Schneider L, Segui-Gomez M, Arbogast K, Augenstein J, Digges KH. The blue ribbon panel on depowered and advanced airbags – status report on airbag Performance. Annu Proc Assoc Adv Automot Med. 2003;47:79-81.

Geyer R. Parametric assessment of climate change impacts of automotive material substitution Environ Sci Technol. 2008;42(18):6973-9.

Hart-Munchel, D.L. Comment: hybrid cars: how they can reduce American air pollution and oil consumption, but why they are not replacing traditional gas guzzling cars and trucks just yet. Penn State Environmental Law Review Fall 2001

Keefe R, Griffin JP, Graham JD. The benefits and costs of new fuels and engines for light-duty vehicles in the United States.Risk Anal. 2008;28(5):1141-54

Knight S, Cook LJ, Nechodom PJ, Olson LM, Reading JC, Dean JM. Shoulder belts in motor vehicle crashes: A statewide analysis of restraint efficacy. Accident Analysis and Prevention. 2001;33:65-71.

Mannino DM, Redd SC. National vehicle emissions policies and practices and declining US carbon monoxide-related mortality. JAMA. 2002;288(8):988-95.

Mayrose J, Jehle DVK. Vehicle weight and fatality risk for sport utility vehicle versus passenger car crashes. The Journal of Trauma, Injury, Infection and Critical Care. 2002;53.

Mazzi, E.A., Dowlatabadi, H. (2007). Air quality impacts of climate mitigation:UK policy and passenger vehicle choice.Environmental Science and Technology, 41:387-392.

McAuley JW. Global sustainability and key needs in future automotive design. Environ Sci Technol. 2003;37(23):5414-6.

McGwin G Jr, Modjarrad K, Reiland A, Tanner S, Rue LW 3rd. Prevalence of transportation safety measures portrayed in primetime US television programs and commercials. Inj Prev. 2006;12(6):400-3.

Mott JA, Wolfe MI, Alverson CJ, Macdonald SC, Bailey CR, Ball LB, Moorman JE, Somers JH, Sheerman B. Motor industry should introduce soft impact car bodies, says MP. BMJ. 2002;324 (7346):1117.

Nichols, M.W. (1998). Advertising and quality in the US market for automobiles. Southern Economic Journal, 64(4):922-939.

Nirula R, Mock CN, Nathens AB, Grossman DC. The new car assessment program: does it predict the relative safety of vehicles in actual crashes? J Trauma. 2004 Oct;57(4):779-86

Paulozzi LJ. United States pedestrian fatality rates by vehicle type. Inj Prev. 2005;11(4):232-6.

Rivara FP, Cummings P, Mock C. Injuries and death of children in rollover motor vehicle crashes in the united states. Injury Prevention. 2003;9:76-81.

Rivara FP, Koepsell TD, Grossman DC, Mock C. Effectiveness of automatic shoulder belt systems in motor vehicle crashes.JAMA: The Journal Of The American Medical Association. 2000;283:2826-2828.

Roberts I, Wentz R, Edwards P. Car manufacturers and global road safety: a word frequency analysis of road safety documents. Inj Prev. 2006;12(5):320-2.

Robertson LS. Prevention of motor-vehicle deaths by changing vehicle factors. Inj Prev. 2007;13(5):307-10.

Robertson LS. Reducing death on the road: the effects of minimum safety standards, publicized crash tests, seat belts, and alcohol. Am J Public Health. 1996;86(1):31-4.

Robertson LS. Blood and oil: vehicle characteristics in relation to fatality risk and fuel economy. Am J Public Health. 2006 Nov;96(11):1906-9.

Samet JM. Traffic, air pollution, and health. Inhal Toxicol. 2007;19(12):1021-7.

Shin, P.C., Hallet, D., Chipman, M.L., Tator, C., Granton, J.T. (September 2005).

Unsafe driving in North American automobile commercials. Journal of Public Health, 27(4):318-325.

Stephan CH, Sullivan J. Environmental and energy implications of plug-in hybrid-electric vehicles. Environ Sci Technol. 2008;42(4):1185-90.

Streff FM. Field effectiveness of two restraint systems: The 3-point manual belt versus the 2-point motorized-Shoulder/Manual lap belt. Accident Analysis and Prevention. 1995;27:607-610.

Tamburro, R.F., Gordon, P.L., D’Apolito, J.P., Howard, S.C. (2004). Unsafe and violent behavior in commercials aired during televised major sporting events. Pediatrics, 114:694-698.

Trowbridge MJ, McKay MP, Maio RF. Comparison of teen driver fatality rates by vehicle type in the United States. Acad Emerg Med. 2007 Oct;14(10):850-5.

Wenzel TP, Ross M. The effects of vehicle model and driver behavior on risk. The effects of vehicle model and driver behavior on risk. Accid Anal Prev. 2005 May;37(3):479-94.

Williams AF, Wells JK, Farmer CM. Effectiveness of Ford’s belt reminder system in increasing seat belt use. Injury Prevention. 2002;8:293-296.

Wilson N, Maher A, Thomson G, Keall M. Vehicle emissions and consumer information in car advertisements. Environ Health. 2008;7:14.

Woodcock J, Banister D, Edwards P, Prentice AM, Roberts I. Energy and transport. Lancet. 2007;370(9592):1078-88.

Yanchar NL, Kennedy R, Russell C. ATVs: motorized toys or vehicles for children? Inj Prev. 2006 Feb;12(1):30-4.

Readers are invited to send additional citations to response@corporationsandhealth.org

 

The Financial Crisis and Public Health: Hidden Opportunities for Prevention?

Posted on by Corporations and Health Watch

In this commentary, CHW founder and director Nicholas Freudenberg examines how the current financial crisis may influence corporate health practices and asks whether the crisis may present the public health community with new opportunities to advance healthier policies and to restore a more just balance between markets and government.

 

Continue reading The Financial Crisis and Public Health: Hidden Opportunities for Prevention?

Where guns come from: Examining the role of industry in firearm availability

Posted on by Corporations and Health Watch

In the flow of guns from manufacturer to consumer, regulations that prevent illegal gun sales are currently too weak to stem gun violence. Health advocates are looking to an Obama administration to boost regulatory practices. This CHW report looks at the firearm industry’s role in making guns available and accessible.

Conflicts over guns are often framed as disputes between those who support the Second Amendment, interpreted to guarantee individuals the right to own guns, and those who want to take guns away from people who want or need them. In fact, public health advocates often have a more narrow goal: reducing illegal trafficking in guns so that those currently ineligible to own guns have a harder time getting them. In this view, the conflict is not about the constitution but rather about how guns are distributed and regulated.

Unlike every other consumer product on the market except tobacco, firearms are not subject to federal safety regulations. “The manufacturers are left to their own devices to sell, make and market guns,” said gun control advocate and Stop Handgun Violence Co-Founder John Rosenthal.

SHV has been working to reduce gun violence with (among other efforts) a billboard campaign. The 532-foot billboard that flanks the Massachusetts Turnpike hopes to bring public attention to the lack of gun regulations. The billboard’s current message highlights how gun shows provide easy access to unchecked gun sales. Every year there are 5,000 gun shows, and in 35 states, private sellers can set up tables at these shows to sell guns without performing ID and background checks.

This Corporations and Health Watch report focuses on the role of gun manufacturers and dealers in making guns available and accessible. We also examine some of the ways that public health professionals, gun control advocates and community organizations are working to reduce gun violence.

Mary Vriniotis, communications liaison for the Harvard Youth Violence Prevention Center and a researcher on the impact of firearms availability says, “There is a vast secondary market through which prohibited buyers can obtain guns. Efforts to identify corrupt dealers, trace guns recovered in crimes, and implement other means of addressing and stemming the flow of illegal guns could be greatly improved with little to no imposition on law-abiding gun owners and dealers.”

David Hemenway, director of the Harvard Injury Control Research Center and author of the book, Private Guns, Public Health (2004) examined legal requirements during two periods in a gun’s ‘life span’: manufacture and point of sale. While both manufacturers and dealers are required to be federally licensed, federal licensing alone is insufficient. In the flow of firearms from manufacturer to dealer to the individual buyer, what’s missing is adequate enforcement of existing regulations as well as additional policies that could reduce illegal sales and gun trafficking.

The First Stop in a Gun’s Life span: Unregulated Manufacturers

Firearm manufacturers are required to be federally licensed, but their business practices are largely unregulated. Information on business operations, including ownership, sales and profits are not publicly available because most manufacturing companies are private (Hemenway, 2004). In addition, their product is not subject to the strict safety regulations in place for other consumer products, which are enforced by federally funded agencies like the US Consumer Product Safety Commission, the Federal Trade Commission and the Food and Drug Administration.

While it may seem paradoxical to enforce safety standards on products that are, by design, harmful, Rosenthal (himself a gun owner) says that, “increasing regulation would reduce death and injury to a fraction of what we are at now.”

The US Centers for Disease Control estimates that firearms were responsible for 30,000 deaths and 80,000 injuries in 2005.

Firearm manufacturers also escape marketing regulations. Marketing and advertising decisions are left to the discretion of manufactures and many gun ads focus on features that increase a gun’s lethality. For example, the Five-SeveN Herstal FN, a Belgian-made handgun sold in the US, can fire armor-piercing bullets. The Brady Campaign to Prevent Gun Violence reports that Herstal FN advertised one variety of the handgun as being able to “perforate 48 layers of Kevlar.” In other words, when loaded with a particular kind of ammunition, the handgun can penetrate body armor worn by police.

Rosenthal said “Gun manufacturers play an enormous role in gun availability,” but under the Bush administration, “manufacturers were let off the hook [when] Congress gave manufacturers immunity.” The Protection of Lawful Commerce in Arms Act (S.397) prohibits civil lawsuits against manufacturers and sellers of firearms.

Next Stop: Licensed Gun Dealers, Weak Enforcement

Guns are sold in one of two markets: via federally licensed gun dealers (primary market), or private sellers (secondary market). Manufacturers only sell their products directly to federally licensed gun dealers, who in turn sell these guns to consumers—provided they pass a federally required background check. But this theoretical pathway is not always followed.

In 1999, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) released a report that found 57% of guns used in crime can be traced back to 1.2% of gun dealers. If a small proportion of dealers are the sellers of guns used in the majority of guns recovered from crime, then there is a break in the legal procurement of guns.

Lori O’Neill, Executive Director of Citizens for Safety-Ohio said, “Federally licensed dealers are complicit in gun violence because they’re responsible for almost 60% of the guns on the street.”

O’Neill and Citizens for Safety are involved in a community action campaign, Where Did the Gun Come From?, which shines a light on data that can be used to reframe gun violence. She said that it is important to shift public awareness from the Second Amendment issue to a crime and public health issue.

With a clear connection between a very small proportion of federally licensed gun dealers and guns used in crime, why doesn’t the ATF intervene to prevent further sales by these dealers? While structurally in place, gun regulation through ATF intervention is often futile. Laws that would ensure ATF and police efficacy are decidedly weak and do not protect the public.

For example, through licensing requirements, federally licensed dealers are known to ATF officers. If an ATF investigation finds that dealers have been selling guns illegally, they can convict the dealers. However, gun dealers’ business is likely to continue because their stock is not confiscated and they are allowed to hand their license to family members. Furthermore, there are so many dealers and so few ATF inspectors that a typical dealer is only inspected about once every seven years (Hemenway, 2004).

With such shocking numbers, “you’d think Congress would use that [ATF] report and make changes and promote public safety,” John Rosenthal said. He believes the main reason Congress does not intervene with comprehensive federal standards to reduce illegal gun sales is due to gun rights lobbying efforts. “It is both fear and influence of the NRA in Congress,” he said.

The NRA recognizes itself as “a major political force and as America’s foremost defender of Second Amendment rights.” In 2007, NRA spent $1.8 million lobbying for gun rights. As a single issue, gun rights groups rank among the top 5 in lobbyist spending with 2007 totals reaching $3.8 million. By comparison, gun control advocates spent $200,000 on lobby efforts.

In the US, citizens can carry a concealed weapon if they meet their state’s requirements. At a minimum, people are required to be 21 years old and pass a criminal background check. If a licensed gun dealer fails to perform these checks, the ATF can intervene. However, as noted above, investigating and convicting licensed gun dealers often does not prevent the problem from occurring again.

Another way licensed gun dealers contribute to illegal gun sales is by selling guns to ‘straw purchasers,’ people who frequently buy guns legally and then resell the guns to prohibited buyers. O’Neill cites testimony from convicted straw purchasers that describe how easy it is to buy lots of guns and sell them on the street or at gun shows (public events where unregulated gun sales occur).

The Secondary Market: Unfettered Gun Sales

Straw purchasers and gun shows are key mechanisms through which guns originally sold in the primary market (licensed gun dealers) are resold via the secondary market. Straw sales are by definition illegal; the buyer is not the end user. Straw purchasers may engage in ‘gun running’: buying guns in bulk in a state with more permissive gun laws, and reselling them on the streets of states with more restrictive gun laws.

But prohibited buyers need not rely on a straw purchaser to obtain a gun. The 5,000 gun shows hosted annually nationwide are a haven for prohibited buyers, as private (non-licensed) sellers are not required to conduct background checks on prospective buyers. In other words, at gun shows, anyone can sell guns to anyone, with few or no questions asked. Even though preventing illegal gun sales could reduce gun trafficking, there are no regulations in place to prevent people not permitted to buy guns from buying weapons at gun shows. Attempts to close the gun show loophole or enact other regulation of the secondary market at the state level are also met with resistance from gun rights lobbyists.

Responding to Gun Violence with Recommended Regulations and Action

In July of this year, the Supreme Court ruled on a Second Amendment case, striking down firearms control regulations in DC. The ruling addressed the scope of the Second Amendment by examining the “rights of individuals who are not affiliated with any state-regulated militia, but who wish to keep handguns and other firearms for private use in their homes.”

In a 5-4 vote on the District of Columbia v. Heller (554 U.S., 2008), the  Justices decided  that Second Amendment rights extend to individuals living in communities with gun bans, such as Washington, D.C. Other cities that passed strict gun laws over the past 30 years in order to protect the public from violence and injury, now face the possibility of having to repeal those laws. In light of this decision, advocates will increasingly look to firearm regulation—not the constitution—to protect public health.

Vriniotis said one-gun-per-month laws, designed to curb gun-running and only implemented in three states, are an example of legislation that can reduce gun trafficking. She said that before Virginia enacted a one-gun-per-month law, many of the guns recovered in Boston came from that state. Now, many of the guns recovered are instead traced to states without this law. “This shows one-gun-per-month laws have an effect on criminal behavior and, if federally adopted, could dramatically reduce the availability of guns to prohibited buyers by impeding the trafficking of guns inside and across state lines,” Vriniotis said.

In an effort to curb gun violence, public health advocates will be looking to President-elect Obama and the new Congress to repeal firearm manufacture immunity. Repeal of this immunity, set out in the Tiahrt Amendment, will restore the public’s ability to hold manufacturers accountable for gun violence.

“Gun manufacturers play an enormous role in the availability of guns,” Rosenthal said, so repealing Tiahrt “is a good place to start.” He also recommends states follow Massachusetts’ lead by imposing consumer safety protection requirements on gun manufacturers.

The Citizens for Safety group uses a community organizing approach to educate people about where guns come from. This past summer, the group started workshops, called Traffic Jam, in six Boston neighborhoods. The curriculum was developed by Citizens for Safety with cooperation from the Boston Police Department and the ATF.

O’Neill said community response has been “unbelievable.” At the workshops, community members construct solutions to illegal gun sales. One program seeks to have multiple stakeholders at the table, including gun dealers, community members and law enforcement. O’Neill said Citizens for Safety is trying to duplicate the successful partnership created this year between the Mayors Against Illegal Guns Coalition and Wal-Mart, the nation’s number one gun seller.

Erica Sullivan is a graduate student in urban public health at Hunter College, City University of New York.