Baby Carrots: Model Product for a New Economy?

Posted on by Corporations and Health Watch

Under what circumstances can the interests of companies and consumer health coincide? Can food companies make a profit promoting healthier food? To find answers to these questions, this month CHW examines a single product—baby carrots. An analysis of the industry and consumer practices contributing to the rise in popularity of baby carrots offer an opportunity to examine how healthy food can mean big profits for food companies.

 Under what circumstances can the interests of companies and consumer health coincide? Can food companies make a profit promoting healthier food? To find answers to these questions, this month Corporations and Health Watch examines a single product—baby carrots. In his classic The Wealth of Nations, Adam Smith analyzed a pin factory to understand the workings of the newly emerging capitalism. He claimed that by understanding this “trifling manufacture” his readers could appreciate deeper economic dynamics. Here, our more modest goal is to gain insights into the connections between profitability and population health.

Baby carrots are in fact not babies at all. They are specially grown carrot varieties that are cut and peeled into a standard size, so they can be packed and eaten without peeling or any other preparation. Baby carrots were introduced in the late 1980s and a decade later, per capita carrot consumption had more than doubled, with nearly all the growth coming from fresh carrots. According to Ken Hodge, communications director for the International Fresh-Cut Produce Association, the rise in carrot consumption is “one of the biggest success stories in produce.”


Health benefits of carrots

Why is increased carrot consumption important? First, carrots are an important source of Vitamin A and the beta-carotene in carrots is available for synthesis into A with little waste or health risk. According to the U.S Department of Agriculture, Americans get 30% of their Vitamin A from carrots. Second, most nutritionists believe that increasing fruit and vegetable consumption brings a plethora of health benefits: reduced rates of heart disease, cancer, diabetes and other conditions and reductions in obesity, an important contributor to the socioeconomic and racial/ethnic health disparities that characterize the United States. Most Americans fail to eat the suggested 5-10 daily servings of fresh fruits and vegetables so finding products that can lead to increases in consumption is an important priority. Baby carrots are convenient and versatile. They can be part of school lunches, snacks, party food or airline fare; sold in bodegas and grocery stores as well as super markets; or served in day care and after school programs. Carrots can be stored in refrigerators for several days, making them attractive to institutional food programs, small stores and ordinary eaters. Easy to serve and store, baby carrots, sticks, and other types of peeled and cut carrots accounted for 69 percent of U.S. households’ expenditures for fresh carrots in 2003.

Baby carrots: a new profit center?

For producers, baby carrots also have attractions. Baby carrots sell for more than regular carrots and many chains now market their own brands of baby carrots. Baby carrots sell for two or more times the price of their full-sized cousins, making them a profitable value-added product. Overall, according to the United States Department of Agriculture, in 2004, the average wholesale price for fresh carrots (in 2000 dollars) was $18.76 per hundred pounds, down from the 20-year high of $21.28 in 1984. Thus, for consumers prices went down while the shift to baby carrots allowed producers to earn more. Since the late 1990s, however, per capita consumption of carrots began to decline, perhaps revealing the fickle tastes of the American consumer or the very modest investments in carrot advertising. (Have you ever seen a television ad for baby carrots?)


Designer carrots

Like so much of the produce we now eat, baby carrots are designer products, literally shaped by growers to make them more marketable. Not only did growers change the shape and texture of the carrot varieties used for baby carrots—they are longer and narrower so they can be cut into four rather than three segments and peeled more easily, resulting in less waste. Growers also selected for taste and texture. Baby carrots are sweeter than other varieties, part of their appeal for children. Some food activists prefer the taste of other carrot varieties such as the purple carrot or less sweet varieties.

Big Carrot Industry dominates baby carrot market

Baby carrots are not a Mom-and-Pop product from the local family farm. According to the USDA, carrot production is highly mechanized and highly concentrated. Carrots used for processing and fresh carrots use mechanical harvesting techniques and two major California firms account for the majority of all carrot products sold. Grimmway, the largest company, planted about 35,000 acres of carrots a few years ago and grows carrots around the year in Southern California. Grimmway markets more than 40 brands of carrots, segmenting its market into multiple slices. Bolthouse Farms, the other big carrot producer, also sells health drinks. Together these two companies produce 90% of the carrots sold in California.

Lessons for health

So what can we learn from the story of baby carrots? First, baby carrots suggest that there are products than can improve health and make money for the food industry. Selling more baby carrots is good for public health and for the bottom line of some companies. Identifying other similar products and developing strategies to promote their use is an important priority for the nutrition and public health communities. Baby carrots also show that consumers will choose healthy, convenient products when they are readily available and that consumption of healthy products can increase rapidly in certain circumstances.

However, baby carrots also illustrate the some of the dilemmas our current food system faces. Promoting baby carrots, arguably good for health, now supports big growers, encourages energy-consuming food transportation patterns, and discourages locally grown produce. Several characteristics of baby carrots make them an ideal mass market product—dependent on mechanized agriculture, convenient packaging, efficiencies of scale for processing, and highly concentrated production that allows a few growers to make money promoting and expanding baby carrot production. These characteristics give baby carrots the potential to get into enough stores, kitchens and mouths to actually change national patterns of vegetable consumption—an important health priority. Yet these same characteristics may undermine other important goals such as sustainability, wider taste variability, a less concentrated food system and more locally grown food.

In addition, although baby carrots are more profitable than uncut carrots, they still constitute a tiny portion of the food market. No one advertises baby carrots, no websites or Internet games encourage children to use them (please contradict me, readers, if you can), and the profit margins on baby carrots or similar products are unlikely to change the dynamics of California agribusiness. Only a publicly subsidized promotion campaign could change this. The experience of the federal Five a Day Fruit and Vegetable Campaign provides a sobering example of the challenges. Its total budget was one third what Lays and Doritos alone spent marketing their chips.

Finally, baby carrots present both a risk and an opportunity for reducing disparities in access to healthy food and improved health for the socioeconomic and racial/ethnic groups disproportionately burdened by our current food system and economy. On the one hand, like so many other upscale products that promote health, baby carrots could become yet another yuppie food—more available to better off communities and more educated individuals and thus exacerbating the already large differences in fruit and vegetable consumption among the poor and the better off. On the other hand, baby carrots are a product that could be part of every school lunch program, served in child care programs, senior citizens centers, jails and homeless shelters, providing healthier, fresher and tastier options to disadvantaged populations. Already many food programs have introduced baby carrots.

For such an approach to yield public health benefits, however, might require subsidies to keep the market growing and prices affordable. Activists working on the Farm Bill have proposed decreasing public subsidies for unhealthy crops like corn, soy and tobacco and increasing them for healthier foods. Baby carrots might make a good test case for the potential of this strategy to yield sustainable changes in the American diet.

In sum, baby carrots help us to understand the potential and limits of the market forces that currently shape our food system. As food and nutrition advocates chart a healthier future food system, it will help to analyze other products and to consider the micro and macro educational, political and economic strategies that can better align market forces with public health. More broadly, concrete empirical analyses of other products that influence health will help public health professionals and advocates to develop new approaches to health promotion and disease prevention. To advance this consideration,Corporation and Health Watch invites its readers to submit ideas or reports on other products in other sectors.

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

Sources

Bonne J. Convenient carrot charms consumers. MSNBC.com July 23,2003. Available at:http://www.msnbc.msn.com/id/3072775/

Brunke H. Commodity Profile: Carrots. Agricultural Marketing Resource Center. Updated and Revised January 2006. Available at: http://aic.ucdavis.edu/profiles/Carrots-2006.pdf

Kuchler F, Stewart H. Price Trends Are Similar for Fruits, Vegetables, and Snack Foods / ERR-55Economic Research Service/USDA, 2008. Available at: http://www.ers.usda.gov/Publications/ERR55/ERR55c.pdf

Nunez J. Off-Colored Vegetables Are Good For You – No Joke. Bakersfield.com, October 10, 2007. Available at:http://people.bakersfield.com/home/ViewPost/33464

Photo Credits:
1. unsureshot
2. amanky

The Depression Epidemic: The “Medication-alization” of Sadness

Posted on by Corporations and Health Watch

Is there really an epidemic of depression or is it, as some have suggested, forces of medicalization at work? This article looks at pharma’s direct-to-consumer advertising practices of marketing antidepressants and the health insurance industry’s influence on the perception of depression prevalence.

Surviving America’s Depression Epidemic, “Depression: Epidemic for a Postmodern Age,” “Depression: The Hidden Epidemic.” These kinds of titles lamenting or questioning the popular lay and professional conception of depression as increasingly widespread have become more and more common in recent years. It is true that depression is understood by many as a major public health problem of epidemic proportions. The United States Surgeon General’s 1999 report, “Mental Health: A Report of the Surgeon General,” stresses the widespread nature of mental illness, with one in five Americans affected by mental illness each year. The World Health Organization describes depression as an epidemic that will, within the next 20 years, be second only to cardiovascular disease in terms of disease burden worldwide.1

But what is an epidemic? And for that matter, what exactly do we mean when we say “depression?” The U.S. Centers for Disease Control defines an epidemic as: “the occurrence of disease within a specific geographical area or population that is in excess of what is normally expected.” The term depression is used regularly in our everyday lexicon to refer to a variety of concepts relating to weather patterns to the state of our economy. We also use the word depression to describe a fleeting mood state—the disappointment after failing a test or a feeling resulting from a particularly sad or “depressing” movie. However, increasingly over the last few decades, the general public uses depression as physicians and mental health researchers do—to refer to a mental illness called “major depressive disorder (MDD),” which, as described above, seems to be affecting more and more of us each year.

If depression is an epidemic then, according to the CDC definition, depression is a disease. It also means that depression is occurring “in excess of what is normally expected.” But what is a “normal” amount of depression? Is the number of people found to be depressed in U.S. higher than what should be expected? Are those diagnosed in epidemiologic studies as depressed experiencing disease or just plain old sadness resulting from the normal ups and downs of life?

There is no doubt that depression is a serious, debilitating condition for sufferers, who can be helped immensely by professional interventions, including medication. But it remains the case that there is no definitive test—no blood test or x-ray—to confirm or deny someone has MDD. This uncertainty about cause and the widespread nature of depression “symptoms” makes depression diagnosis malleable and suggestible—offering opportunity to the pharmaceutical industry to expand sales by expanding what is considered treatable “illness.”

Medications work on our biology and therefore pharmaceutical companies depend on biological definition of depression to sell their products. Because of the difficulty in identifying clear cut biological mechanisms for the diagnosis of various mental disorders, the degree to which the mental is medical remains contested.

Medicationalization—DTCA

The medicalization of “sadness,” as it is called by critics of the depression as epidemic perspective, points to direct to consumer (DTC) advertising of antidepressants by pharmaceutical companies as a major vehicle in the expansion of depression diagnoses.2,3 “Medication-alization” seems more like it. In 1997, The Food and Drug Administration approved the use of DTC drug advertisements in broadcast media (TV and radio); before that, advertising was relegated to publications targeted at physicians.4 By 2000, the pharmaceutical industry was spending more than $2 billion on DTC advertisements.

DTC ads for antidepressants typically feature the DSM defined symptoms of major depressive disorder in conjunction with explicit reference to biological etiology, defining depression as a “chemical imbalance” or lack of normal levels of the neurotransmitter serotonin in the brain. While this was once a promising theory, science has not borne out the truth of the “chemical imbalance” theory.5 Today’s science increasingly depicts depression as resulting from a highly complex interaction of human biology, genetics, psychology, and social and physical environments. But even though psychiatry shies away from direct claims about cause, the pharmaceutical industry is sticking with what works—and the result is continued sales. SSRIs have come to be some of the best selling drugs of all time, and the success of these drugs has lead to a proliferation of new antidepressants on the market for depression and a variety of other mental health problems.

Managed care and mental health treatment

Around the time that SSRI antidepressants came on the market in the late 1980’s to early 1990’s, managed care was expanding. Managed care prefers the quickest, least expensive treatment alternatives. In the case of depression treatment that means medication over psychotherapy. The result—patients seeking care for depressive symptoms were more than four times more likely to receive medication for depression in 1997 than in 1987.6

What doctors can diagnose and prescribe as treatment is subject to the approval of a patient’s health insurance companies and what it defines as acceptable diagnosis and treatment. To the degree that patients are unable or unwilling to pay for service out of pocket, they must seek the services covered by their health insurance carrier, all of whom employ at least some managed care practices these days. With recent mental health parity legislation, insurance companies being forced to provide increased psychotherapy benefits, but most still have strict limits on coverage, ironically requiring a mental health problem to be deemed “biologically-based” by the provider to get reimbursed for psychotherapy treatment services.

Protecting the healthy

The number of people experiencing the “symptoms” of Major Depressive Disorder may be plenty. No doubt, the symptoms of depression are common and widespread human experiences. We may have a lot of depression going on, but that there’s “disease” in excess of what’s normally expected in this case is less certain.

Contrary to popular sentiment, while lots of people may be experiencing symptoms of depression, it’s not clear that this is occurring at higher rates than in the past, nor is it the case that everybody who goes to their doctor is clamoring for medication. But with Pharma, physicians and health insurance industries telling us that yes, our experience is very common, but no, it is not normal, and that medication is our best option for feeling better, it’s no wonder that we’ve got a society ripe for viewing depression as an epidemic.

No question society needs to make the protection of the rights and interests of persons with mental illness a priority since they have in the past often been ignored and trampled on. But convincing people who are sad or live in difficult circumstances that the only way they can get better is to take a powerful drug carries its own dangers. Only by critically analyzing the social forces that have created the “epidemic” of depression can we chart effective policies to recues its burdens.

 

References

1 Summerfield D. Depression: epidemic or pseudo-epidemic? Journal of the Royal Society of Medicine. 2005: 99: 161-1.

2 Horwitz A, Wakefield J. The loss of sadness: How psychiatry transformed normal sorrow into depressive disorder. Oxford: Oxford University Press; 2007.

3 Conrad P. The shifting engines of medicalization. Journal of Health and Social Behavior. 2005: 46(1): 3-14.

4 Conrad P, Leiter V. From Lydia Pinkham to Queen Levitra: DTCA and medicalization. Sociology of Health and Illness. 2008: 30: 825-838.

5 Lacasse JR, Leo J. Serotonin and depression: A disconnect between the advertisements and the scientific literature. PLoS Medicine. 2005: 2(12): 1211-1216.

6 Olfson M, Marcus SC, Druss B, Elinson L, Tanielian T, Pincus HA. National trends in the outpatient treatment of depression. JAMA. 2002;287:203-209.

 

Photo Credits:
1. angelinawb 

Sara Kuppin, DrPH, is a postodoctoral fellow in Urban Public Health at Hunter College.

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.

 

Photo Credits:
1. hughelectronic 
2. dust
3. hippie

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.

 

Image Credits:

1. vox_efx
2. poolie
3. specialkrb
4. specialkrb

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

Downdload the PDF

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.