Big Pharma Getting Legal Heat for Marketing Tactics

Posted on by Corporations and Health Watch

The pharmaceutical industry has had a lot of success in recent years. Its profit margin is about 16%, seventh highest of the 215 industries tracked by Morningstar, an investment research company. In 2003, the drug industry succeeded in getting Congress to pass and President Bush to sign the Medicare Expansion Act that, by some estimates, increased drug industry profits by $139 billion. And last year the Pharmaceutical Researchers and Manufacturers Association (PhRMA) made a deal with President Obama to cut costs for some drugs in exchange for a commitment not to allow the health care reform bill to allow importation of drugs from other countries or to fix prices. As a result, the pharmaceutical industry will get assured reimbursement for drugs for millions of additional Americans.

With these successes, one would think that the pharmaceutical industry would be satisfied with using its clout to set the rules for its own benefits. Instead, however, a recent series of news reports shows that pharmaceutical companies are regularly attracting the attention of legal authorities in their aggressive marketing of drugs. Consider the following:

Why do drug companies break the law?

First, according to legal and academic observers, they don’t appear to respect or fear the law. According to federal prosecutor Michael Loucks, then the head of the health-care fraud unit of the U.S. Attorney’s Office in Boston, when lawyers for Pfizer Inc., the world’s largest drug company, promised him in January 2004 that the company wouldn’t break the law again, they knew the company was involved in other illegal promotions. “At the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct in 2004,” said Loucks, “Pfizer was itself in its other operations violating those very same laws. They’ve repeatedly marketed drugs for things they knew they couldn’t demonstrate efficacy for. That’s clearly criminal.” According to Jerry Avorn, a professor at Harvard Medical School in Boston and author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs, “Marketing departments of many drug companies don’t respect any boundaries of professionalism or the law. The Pfizer and Lilly cases involved the illegal promotion of drugs that have been shown to cause substantial harm and death to patients.”

Another reason for widespread lawlessness is that the fines represent a small portion of drug industry profits. As large as the penalties are for drug companies caught breaking the off-label law, the fines are tiny compared with the firms’ annual revenues. According to Bloomberg News, the total of $2.75 billion in fines that Pfizer has paid in off-label penalties since 2004 is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008.

Finally, companies break the law because they think they can get away with it. The Food and Drug Administration has been chronically understaffed, dependent on the drug industry for the fees that support its operations and using experts in the pay of the very industries they are regulating. According to Dr. Marcia Angell, a former editor of the New England Journal of Medicine, “There is growing evidence that the Center for Drug Evaluation and Research, the part of the [Food and Drug] agency that regulates prescription drugs, has become the servant of the industry it regulates.” Whether the new tougher stance of the current FDA will be able to reverse these trends remains to be seen.

In sum, the drug industry resorts to lawless activities because they face relentless pressure to maximize profits and cut costs, because they often see the law as an obstacle to profits rather than a legitimate moral framework that should govern their behavior and because the regulatory agency charged with monitoring the drug industry has often lacked the resources and sometimes the will to provide aggressive oversight. Protecting public health against dangerous and illegal promotion of prescription drugs will require changing these three dynamics.

Photo Credits:

  1. epSos.de via Flickr

Merging Medicine and Marketing: An Interview with Ray Moynihan, Author of Sex, Lies, and Pharmaceuticals

Posted on by Corporations and Health Watch

Ray Moynihan is an award-winning health journalist and researcher, and co-author of the bestselling book Selling Sickness: How the World’s Biggest Drug Companies Are Turning Us All Into Patients, which was published in 2006. His latest book, Sex, Lies, and Pharmaceuticals: How Drug Companies Plan to Profit From Female Sexual Dysfunction, written with Dr. Barbara Mintzes, will be released this October. The book builds on his past work and explores how pharmaceutical companies are helping to define and construct women’s sexual difficulties as symptoms of a new disorder. In August, medical anthropologist S.D. Gottlieb interviewed Ray Moynihan for Corporations and Health Watch about the role of the pharmaceutical industry in defining pathology and his new book. What follows is an edited version of that interview.

CHW: Can you explain to the readers of Corporations and Health Watch what it means for pharmaceutical companies to be creating diseases and disorder?

RM: I don’t normally say that companies create diseases. What the evidence suggests is that companies have helped to sponsor the creation of diseases, to create the scientific building blocks of disorders. This can happen in a range of ways. The boundaries that define conditions can slowly be widened. We’ve seen this happen with depression, with Attention Deficit Disorder, we’re seeing it now with female sexual dysfunction. Some of the ordinary ups and downs of life become blurred with the symptoms of medical conditions. This has become one of the elements of contemporary pharmaceutical company marketing because the more people who can be labeled as requiring a pill, the bigger the markets for the drugs. It’s often a subtle process. You’ve got to follow the money to look at the relationships between the companies and the medical profession. When you do that what we see is a merging of marketing and medical science. In the United States particularly, pharmaceutical marketing is off the leash. A key aspect of that marketing is telling as many people as possible that they need not just one drug but a range of drugs. The marketing is insidiously trying to make us feel as if the ups and downs of life are the symptoms of conditions that require drugs. Anyone living in the United States with a television will recognize these: overactive bladder, stomach problems, mild depression, or a bit of unusual busyness in children. Now we have adult ADD as well. This insidious process is largely unregulated because the regulators focus on drugs, not on the science that defines the conditions.

CHW: That’s a great point. Can you speak more about the problem of the difference between regulation and actual oversight of how pharmaceutical companies develop these notions of pathology?

RM: When you look at the specific panels of doctors who sit down and define illnesses, conditions, and the boundaries of high cholesterol, higher blood pressure, type 2 diabetes, or depression—the doctors actually sit down around a table and decide who is sick and who is healthy—you’ll find that many of those doctors are extremely close financially to the drug companies, and will clearly profit if those boundaries are set as widely as possible. Now this is a crude analysis because it comes out of investigative journalism, not a long history of academic research. Certainly there’s been wider debate about medicalization for a long time, but what I’m trying to do is throw the spotlight on the process by which conditions, diseases, dysfunctions, and disorders are being generated and promoted, The closer you look at that process, the more that it smells.

CHW: So to probe a little deeper, you have a book coming out about the idea of female sexual dysfunction. Can you tell us about this category—how is it constructed and what does it mean?

RM: Female sexual dysfunction does have a technical definition in the pages of the Diagnostic and Statistical Manual of Mental Disorders, but I won’t bore your readers with those details. But there are technical definitions. DSM-4 defines four sub-disorders: disorders of desire, arousal, pain and intercourse, and orgasm.

CHW: And do they all have to be present in order to diagnose FSD?

RM: No, they don’t. They are four separate sub-disorders. But that formal definition is constantly in play and is extremely controversial. For the last decade, there has been a cogent, well organized, and small but effective campaign to criticize those formal definitions and promote an alternative view. That’s an incredibly important part of this story. But back to the definitions themselves. For the last decade or so, there’s been an attempt to portray female sexual dysfunction as being a widespread and treatable medical condition that could affect up to 43% of women. That figure sounds absurd, but it is still widely used by people within the medical profession. It comes from a 1999 article in the Journal of the American Medical Association. It somehow has a degree of scientific credibility, despite the fact that many people have criticized the figure and now that figure has largely been discredited. So the simplistic narrative that has been promoted is that 43% of women have this condition, that it can be severe, under-diagnosed, and it can respond to treatment. And anyone who questions this narrative must be trying to disrespect or delegitimize the genuine suffering of women.

CHW: Isn’t that a slippery slope, to be critical of this diagnosis because it could suggest a lack of recognition of the plight of women?

RM: Absolutely. Almost everyone who is critical of the way in which this condition has been promoted acknowledges that sexual difficulties are widespread and that sometimes those difficulties are so debilitating that a medical angle and a medication may be the best strategy. I don’t think there’s any denying that. The controversy is about the extent of those treatable medical problems. And I think that estimates like 43% are clearly such vast exaggerations that they themselves have sparked a backlash of rationality. When you drill behind that 43% figure and look at the surveys from which it comes, you realize that it in no way represents the proportion of women with treatable medical problems. It represents the proportion of women who say yes to having experienced very common ups and downs in their sex lives. People who have had lack of interest in sex for a few months, people who have had problems with pain, people who have had problems with orgasm. Very common aspects of sexuality that have been categorized as the symptoms of a treatable medical condition.

CHW: Can you clarify why you think these experiences might not require medical intervention?

RM: Sure. In 2000, the New View Campaign was co-created by a New York psychologist called Dr. Leonore Tiefer. This is a global campaign that has a totally different way of framing sexual difficulties. They talk about sexual problems and why women might suffer sexual difficulties. In their view, a passing lack of interest in sex is not something that should be pathologized, not something that should be seen as a symptom of a disorder called Hypoactive Sexual Desire Disorder. It’s an aspect of ordinary life that sometimes is so serious and severe that professional help may be necessary and valuable, but in many cases is not.

CHW: To bring it back to the production of the disorder, a lot of readers probably know about the successful—and profitable—male sexual dysfunction drugs on the market, the most familiar version of which is Viagra. In your view, how has the development and marketing of female sexual dysfunction drugs differed from or paralleled the drug for erectile dysfunction?

RM: The biggest difference is that despite ten years or more of trying a whole range of different drug therapies, nothing has yet been successful in terms of female drugs, whereas my understanding is that the trials of Viagra showed fairly good evidence of effects. But when it’s come to trials of drugs for female sexual dysfunction, so far the FDA has approved nothing. To date, there have been three main waves of potential drugs to treat this condition. First, there was Viagra. The trials of that showed that for women it didn’t work any differently from a placebo. Secondly, there was testosterone, and that failed at the FDA because of fairly negligible benefits but serious risks of harm. And then thirdly we’ve just had this drug called flibanserin which affects the neurotransmitters in the brain, and that just recently failed as well. So I think in all these trials we have seen the power of the placebo.

What is similar is that as the drug companies approach the FDA approval for these drugs, they put a lot of energy into what’s called preparing the market, trying to cultivate the market so that as soon as their drug is approved, a lot of doctors are ready to prescribe. And we saw this most beautifully this year, 2010, when the German drug company Boehringer Inglheim were seeking approval for their drug flibanserin in June. For the last couple of years, behind the scenes, very quietly, Boehringer has been developing links with senior researchers within the world of sexual research. It’s been holding forums, it’s been starting to prepare the market, it’s been funding medical education, things like that. In May 2010, they sponsored a very aggressive media assault that rolled out across the United States and the world, trying to frame sexual difficulties in women as a problem in the brain. They claimed that their drug, which was about to go up for approval, could then be the white knight that rode in on a horse to fix the problem. Things didn’t go according to plan. The FDA rejected the drug. So in a sense there are very similar marketing strategies at play here, but one of the big differences is there’s been no drug approved yet in the United States.

CHW: My understanding of Viagra’s history is that it was more or less coincidence that its indication for erectile dysfunction was discovered. From what you’re saying, it sounds like the female sexual dysfunction pill has been much more directed in its intentions than the discovery of Viagra.

RM: You’re right. Viagra was being tested for something else and this was discovered as a serendipitous side effect and that then became the main indication. And I think that the discovery of Viagra’s sexual benefits for men in the 1990s immediately sparked enormous interest on the part of Pfizer and other companies in the possibility of a market among women. So a lot of energy is going into trying to find a drug that may get approval here. And of course testosterone is used in men and so it was a natural idea to try it in women. The German drug company that has brought us flibanserin also has a similar narrative to the Viagra narrative. Boehringer Inglheim says that flibanserin’s sexual benefits were only discovered accidentally, because the drug was originally tested as an antidepressant. And as it happened, it failed as an antidepressant and now it looks like it may have failed as a sexual dysfunction drug as well.

CHW: Let’s go back to the ideas of companies framing and structuring the marketplace, instead of creating markets. I’m wondering about the innovation-oriented conferences. I read one of your 2003 articles about female sexual dysfunction and you mention in that article the idea of innovation-oriented conferences where so-called “knowledge and opinion leaders” in the pharmaceutical world are coming together to educate other clinicians, to create a community of experts, and to use clinicians as emissaries to other clinicians.

RM: Yes, that’s exactly right. There really is a very frightening merging of marketing and medical science going on, often behind closed doors at these so-called scientific gatherings. The extent of involvement of drug companies in these so-called scientific gatherings has really gotten out of control. Particularly in the early 2000s when this disorder was being developed as a widespread epidemic, the extent of involvement of Pharma was extreme. So not only did companies fund, sponsor, place their booths, and have their marketing people interact with doctors and researchers at these events, the company representatives were actually inside the educational lecture halls taking part in all of the debates, and these debates were actually defining what is human pathology and what is normal life. So drug companies help to define their own markets. I was at a conference in Paris just last year and to my dismay, the senior drug company marketing staff were not just there flogging their drugs, they were in the mainstream so-called scientific discussions, going on about how to define and treat these conditions.

Let me briefly describe three of the building blocks where this merging of medicine and marketing is happening. One is the studies of prevalence. So when we hear studies that say one in ten women have Hypoactive Sexual Desire Disorder, sometimes these surveys are being designed and executed by drug companies. So if you look closely at the fine print of the journal articles that produce these prevalence estimates, these big surveys, companies are actually explicitly involved in them. The next thing is the measurement tools – the tools that are used to measure whether or not a woman suffers from this so-called condition, and whether or not a drug helps. Drug companies have actually created those measurement tools. They’re not being done independently outside the companies, they’re being specifically created by company staff. The third area, and this is perhaps the most shocking, is the diagnostic questionnaires that are used to determine whether or not someone has Hypoactive Sexual Desire Disorder are actually being created by the staff from the companies who are making the drugs for the same condition. In the book Sex, Lies, and Pharmaceuticals I present this evidence. It’s referenced and fact-checked within an inch of its life.

CHW: How would you say that pharmaceutical companies defend this practice when they’re called to task?

RM: I think that we’ve all slowly slipped into these processes. The closeness between the pharmaceutical industry and the medical profession is at least a century old. Recently, the relationship has gotten closer, and in the last decades of the 20th century, without knowing it, we’ve seen a frightening merging of the profession and the industry. In the first decade of the 21st century, the world is starting to wake up to this and we’re seeing widespread concern about this overly cozy relationship between doctors and drug companies. In America, there are now new laws that will force companies to reveal every single payment to every doctor that they put on the payroll. These are unprecedented levels of transparency, and ultimately they’ll produce a new independence in the relationship between industry and the profession.

What’s flown under the radar in all of this is the way in which this closeness has actually started to affect how we define illness. And direct-to-consumer advertising in America has been the vehicle by which the industry has helped to pathologize vast swaths of the healthy population. So far, industry has not really been called to account for this, because this analysis is still not widely understood. On the rare occasions that the industry does have to answer the criticism that it is widening the boundaries of illness, companies simply say that they are responding to legitimate areas of unmet need, legitimately funding science to help bring an end to suffering and improve the health of people and populations, and that its relationships with professionals are entirely appropriate and legitimate, and legal and acceptable. That is their standard approach.

They can’t really deny any of the evidence that we’re discussing, because all the evidence is there. In this new environment, it will be interesting to watch where there is a genuine push for more independence between health professionals and industry and what effect that will have on the way in which we define illness. If we bring a whole fresh bunch of people, good people, and ask them to put their minds to this problem of how to define an illness without that conversation being in the shadows of the pharmaceutical companies, I think we might come up with some very different sorts of answers. We may not find that diseases and definitions keep being broadened.

CHW: The United States FDA advisory panel recently issued a recommendation against the Boehringer Inglheim oral drug for sexual dysfunction that’s pending FDA approval. Many people don’t recognize that there’s an advisory panel that’s separate from the FDA regulatory panel. In 2000, the FDA issued preliminary guidelines to help companies plan human studies of drugs for female sexual dysfunction complaints. Can you talk about government involvement in promoting companies’ developments of new categories of illness?

RM: The FDA has its hands full trying to understand the risks and benefits of pharmaceuticals and other products. I would argue that it is not qualified to critique and evaluate the science behind the actual conditions. The regulators, like almost everyone else, take on good faith the disease definitions that are handed to them by groups of experts within the medical profession. But we can no longer take those definitions on good faith. We must look closely at them, who has defined them, who has funded them, and at the relationships between the people doing the defining and the drug companies. And really, I think, we need to start again.

Even this year, I don’t think the advisors to the FDA were well enough aware of the deep controversy surrounding this thing called HSDD, Hypoactive Sexual Desire Disorder. You have a bizarre situation occur where the FDA’s advisors and the FDA are assessing a drug for a condition called HSDD, while at the same time, a panel that is rewriting the DSM, the manual of diseases, has proposed abandoning HSDD as a disease entity. So, in fact, HSDD may no longer exist within a couple of years, and yet the FDA is happily and enthusiastically assessing a drug for this condition. This is just one example where I think the FDA regulators generally need to be a lot more rigorous in their analysis of claims about the nature of conditions. The other important thing to say is that the FDA has actually explicitly encouraged companies to design the instruments that measure the success of their drugs. I find that bizarre but I think it flows from something deeper. Increasingly, health care and medicine are not seen just as something that helps prevent disease and augments human health. Rather they are seen as industries, very large industries, and the FDA sees its role as facilitating that industry. Don’t forget that the FDA itself is funded in a very big way by industry.

CHW: And populated with people who have a lot of industry experience as well. It’s self-contained in some way.

RM: That’s right, and there are often debates within the FDA itself about the extent to which it is too close to industry. At least one bill has been proposed to end industry funding for the FDA. I suppose these are deeper and bigger debates for another day, but they’re certainly relevant to this debate about how conditions are constructed and promoted.

CHW: As our final question, I wanted to ask about one of the things that prompted my interest in this most recently, which is the Boehringer Inglheim website called sexbrainbody.com. It’s one of many drug company educational content websites that precede FDA approval. What do you think are the benefits or challenges that websites might provide for patients?

RM: The pharmaceutical industry and their allies are asking us to believe that their promotion and marketing is actually information and education. This is a deep assault on our sense of reason and I really don’t understand how the assertion can even be made. That’s the big picture answer to your question. The smaller answer is that consumers need to be extremely skeptical of any sources of information that are sponsored by the drug companies or other industries with vested interests in the outcome of that information. I think that the sexbrainbody website was a crude attempt by Boehringer to help build the market for its drug. These promotional exercises, even though there may be independent people involved in running them, need to be heavily labeled. There should be laws that mandate that the sponsorship should be front and center on the front page of such websites. The sad thing is that there are not easily, readily accessible websites that offer truly independent information and education. The few sources that are around don’t have the firepower behind them that a drug company hungry for a new market can bring.

This question of who educates consumers about drugs is raging in Europe at the moment, as the drug companies are attempting to introduce direct-to- consumer advertising into Europe under the guise of providing information to people. And we’re living through a very strange epoch where the belief that knowledge can be generated independently of corporate interests is under threat. Somehow we have come to believe that corporate involvement in the generation of information of knowledge or education is acceptable, actually something to encourage. It’s a blurring of categories.

CHW: Thank you so much.

Ray Moynihan was interviewed by S.D. Gottlieb, MHS, PhD, anthropologist and author of the recent dissertation entitled, “Manufactured Uncertainty: the Human Papillomavirus and the Object Multiple.”

For other related CHW posts, see:

Image credits:

  1. Bashed
  2. Feggy Art

Vaccine Promotion in the Hands of a Corporation: The Missed Opportunity of Merck’s Marketing of Gardasil

Posted on by Corporations and Health Watch

Over the last several years, human papillomavirus (HPV), one of the most common sexually transmitted infections in the United States, has gone from relative obscurity to a source of heated debate and, for some, a new cause for fear. Casting a new spin on an old infection, Merck Pharmaceuticals single-handedly produced more widespread familiarity with the virus and manufactured the catalyst for conversations about HPV and cervical cancer. In June 2006, Merck received FDA approval for a new vaccine that protects against four of the more than thirty types of sexually transmitted HPV, Gardasil. Even before its approval, Merck advertised the coming vaccine indirectly with the teaser “Tell Someone.” In doing so, Merck began the process of using marketing to position a vaccine that protects primarily against a common sexually transmitted infection instead as a powerful vaccine against cancer.

The HPV vaccine debuted on the market with an advertisement campaign explicitly acknowledging women’s lack of familiarity with the virus and its consequences. The television ads featured women talking directly to the camera, exclaiming, “Cancer caused by a virus…I didn’t know that!”

As the “Tell someone” campaign encouraged its viewers, sharing this knowledge with other women was critical. Concurrent with its direct-to-consumer advertising, Merck also launched an “Educate the educators” session to inform physicians about the new vaccine, anticipating a fair amount of public resistance to vaccinating girls (ages 9-26) with a vaccine that might minimize the consequences of sexual activity. The importance of this education also stemmed from the fact that HPV is not well understood even among many physicians, likely as a result of the many types of HPV that exist. In a physician education session targeting gynecologists that I attended, the majority of the session focused on the epidemiology of the virus, and session leaders failed to discuss any of the existing treatment options, which most attendees would be using in their everyday practice. In other words, Merck seemed to expect that even physicians had vague knowledge about one of the most common STIs.

At its FDA hearing, Merck explicitly focused on the vaccine as a response to a variety of working groups that sought to reduce mortality due to cervical cancer. The promotion of the vaccine and the management of the trial data stressed that the “need” was for a cancer vaccine, not for a vaccine to prevent a highly transmissible and very prevalent STI. Some of this focus may reflect the company’s desire to minimize parental resistance to the vaccine. In the months leading up to the vaccine’s distribution, a variety of popular press articles questioned whether a vaccine for an STI could really gain acceptance in the United States, with its recent history of abstinence only programs in lieu of sexual health education. The reactions from a number of conservative family organizations, like Focus on the Family, and these groups’ public acceptance of the vaccine also suggest that Merck packaged its campaign to address their concerns. Once the FDA approved the vaccine, these groups acknowledged that they were not against a vaccine that protected against cancer, but they were against government requirements of the vaccine. This carefully worded response played into Merck’s own positioning perfectly. While the vaccine does prevent the infection with some types of HPV that can cause cancer, cancer is not, in fact, an inevitable outcome of an HPV infection. This point, though small, is rather critical. Merck’s entire advertising campaign has focused on HPV’s cancer potential; a recent advertisement that leads the viewer to visit Merck-owned HPV.com portrayed a young woman’s (heteronormative) life dreams (college, travel, boyfriend, marriage) as pre-empted by her health decline into a cancer that could be prevented. HPV.com directs the viewer to learn more about preventing the STI by sending her to the Gardasil website. The tagline for this promotion is quite simple: HPV. Why risk it?

Once Merck received its FDA approval, the campaign progressed from the vague and non-specific “Tell Someone,” into “One Less” (woman/girl with cervical cancer) and then to “I Chose.”

In addition to its advertisements, Merck created a program initially called “Make the Connection,” which was renamed “Make the Commitment,” that offered make your own bracelet kits for free that would donate money to a cancer research organization. A number of celebrities participated in the purported “public service announcement” promotions, which have since been discontinued.

The Gardasil campaign, which included non-transparent lobbying of state legislatures to require the vaccine for school-entry, revealed that the pharmaceutical company’s message and the everyday experience of/practice around HPV infection were not completely coherent with each other. Merck’s education campaign pushed the vaccine as an unquestionable necessity, neglecting to mention how highly effective other technologies of gynecological care can be to reduce cervical cancer. The Pap smear, for example, has been used in the U.S. since the 1940s, and while it is an imperfect science, its institutionalization through gynecological guidelines have reduced American women’s deaths from cervical cancer to about 3,400 a year from more than 70,000 annually in the 1970s. Still, the consequences of HPV morbidity are not insignificant and reducing the spread of the disease is not inconsequential. What causes concern, however, is Merck’s positioning of Gardasil as a cervical cancer vaccine (not an STI vaccine), which in fact complicates how women may understand the benefits and limitations of the vaccine. What remains problematic about Merck’s campaign is that even with the HPV vaccine, women will need to have the same gynecological screening and treatment that women experienced before the vaccine. Women’s experiences with gynecological care may not change radically.

Merck’s vaccine (and now GlaxoSmithKline’s recently approved vaccine) is not intrinsically bad; such a position is uncomplicated and fails to take into account the fact that HPV can be a serious infection, regardless of whether it develops into cancer or not. However, the company’s willingness to use fear to incite parents and young women to vaccinate casts doubt on the insistent message that the vaccine will liberate women from traumatic health care experiences. Gynecological care is not without its limitations. Technicians read hundreds and hundreds of Pap smear slides in a day. Human errors can contribute to the progression of HPV to cervical cancer, and clinicians’ and patients’ continued uncertainty about the most appropriate interventions and even prevention make the vaccine a very powerful prophylactic.

Merck invested a lot of time and money in “educating” people — public health officials and providers in particular — about HPV and cervical cancer as the vaccine became available and widely disseminated. Tracking exactly how and where the money has gone is difficult because, like the program for Make the Connection/Commitment, Merck’s strategies appear to have included supporting a number of non-profits, such as Women in Government, an organization that lobbied in various states for the vaccine requirements in schools. But all its investment in education stressed the necessity of the vaccine, rather than focusing on preventive health as a more comprehensive strategy. Because a more comprehensive cervical health education focus might obviate the urgency of the vaccine, the emphasis in all the educational materials was on the ubiquity of HPV and the challenges of preventing its spread.

Throughout Merck’s HPV and Gardasil advertisements, little has been said about the treatability of cervical cancer or the success at preventing HPV from progressing to cancer. Much like other pharmaceutical interventions designed to make life easier, when available solutions exist to address the same problem, Gardasil offered an alternative but is not a panacea. Many of the screening techniques and preventive health services are less expensive (per use) than the high cost (and incomplete levels of protection) that the vaccine presents. Though Merck has set up programs to allow low-income women (and presumably now men, since its FDA approval in boys and men in September 2009) to receive financial assistance to get the vaccine, Gardasil debuted on the market as the most expensive vaccine. Costing nearly $350 for the three shot series, the vaccine initially was a big money maker for Merck with $1.4 billion sales worldwide in 2007. Its first quarter report in 2010, however, showed an 11% decrease in sales from the same time last year. Sales of the vaccine, however, are harder to track than other treatments, because governments fuel much of the purchasing, with programs like the United States’ Vaccines for Children program and county public health programs’ acquisition of the vaccine. Current research suggests that there are still significant disparities between women/girls who receive the vaccine and those who don’t. Much like the disparities in cervical cancer rates (and deaths), class and race seem to be the distinguishing factors in terms of who gets the vaccine. With further approval to market the vaccine to older women, Merck is capturing a large market share of people who may not benefit from the vaccine.

Because Gardasil only protects against some and not all types of HPV, promoting a more comprehensive education scheme would have not compromised Merck’s campaign. Merck’s rush to lobby state legislatures to require the vaccine for school entry, for example, seriously undermined the public’s trust in their motives. Instead of transparently lobbying (though perhaps an unrealistic expectation in American government), Merck used a number of indirect channels to promote state laws (for instance, Women in Government) that subsequently failed almost nationwide. Merck publicly announced it would no longer lobby state legislatures after the Texas governor overrode the state legislature debate. This sort of aggressive push devalues the real potential benefits the vaccine might offer young women.

It seems clear that there was an incredible opportunity available at the moment of Gardasil’s debut. A vaccine that protects against an STI that can slowly progress into cancer is a significant accomplishment. Offering women the opportunity to reduce their health risks and preempt an often painful and stressful set of morbidities associated with HPV infection was also a significant coup. Raising awareness about HPV, the difficulty in preventing it, and reducing cervical cancer mortality globally are all meaningful developments. But Merck did not manage any of these well and used its advertising campaign to manipulate women by playing on their ignorance or confusion about their health care. While the campaigns framed the decision to use the HPV vaccine as women’s own proactive involvement in their health care, the messages have been frightening and unsettling unnecessarily. Merck has handled its campaign irresponsibly, choosing not to frame the message simply and with straightforward information, perpetuating the notion that HPV and cervical cancer are a mysterious threat that can only be stemmed through vaccination. Since this is not true, and women will still get HPV and may still get cervical cancer, the message remains deeply problematic and even paternalistic.

By S.D. Gottlieb, MHS, PhD, anthropologist and author of the recent dissertation entitled, “Manufactured Uncertainty: the Human Papillomavirus and the Object Multiple.”

Photo Credit:

  1. neofedex

Healthy Skepticism: Countering misleading drug promotion advertising and promoting healthy skepticism about pharmaceutical marketing practices

Posted on by Corporations and Health Watch

Healthy Skepticism is an international non-profit organization with headquarters in Adelaide, Australia. Its website http://www.healthyskepticism.org offers a collection of journal articles focusing mainly on the problems that arise when pharmaceutical companies advertise directly to physicians and publishes a monthly newsletter for its member subscribers.

Healthy Skepticism is an international non-profit organization with headquarters in Adelaide, Australia.  Its website, www.healthyskepticism.org, offers a collection of journal articles focusing mainly on the problems that arise when pharmaceutical companies advertise directly to physicians.  Other articles deal with problems arising from Direct to Consumer (DTC) advertising, misleading and unethical advertisements, and issues such as government policies on pharmaceuticals. In a fact sheet, the organization offers seven reasons why we should all be concerned about the harmful effects of drug promotion.

This extensive collection includes references for over 16,000 articles and is updated regularly.  In addition, the organization publishes a monthly newsletter for its member subscribers, most of whom are physicians and pharmacists.  You may become a free subscriber by using this link http://www.healthyskepticism.org/lists/?p=subscribe.

Selected Bibliography on Retail Practices and Health by Industry

Posted on by Corporations and Health Watch

Selected Bibliography on Retail Practices and Health in the Alcohol, Automobile, Firearms, Food and Beverage, Pharmaceutical, and Tobacco industries.

 

Alcohol Industry

  • Cohen DA, GhoshDastidar B, Scribner R, Miu A, Scott M, Robinson P, et al. Alcohol outlets, gonorrhea, and the Los Angeles civil unrest: A longitudinal analysis. Soc Sci Med. 2006;62(12):3062-3071.
  • Gruenewald PJ, Freisthler B, Remer L, Lascala EA, Treno A. Ecological models of alcohol outlets and violent assaults: Crime potentials and geospatial analysis. Addiction. 2006;101(5):666-677.
  • Gruenewald PJ, Johnson FW, Treno AJ. Outlets, drinking and driving: A multilevel analysis of availability. Stud Alcoho. 2002;63(4):460-468.
  • Gruenewald PJ, Millar AB, Treno AJ, Yang Z, Ponicki WR, Roeper P. The geography of availability and driving after drinking. Addiction. 1996;91(7):967-983.
  • Kotecki JE, Fowler JB, German TC, Stephenson SL, Warnick T. Kentucky pharmacists’ opinions and practices related to the sale of cigarettes and alcohol in pharmacies. J Community Health. 2000;25(4):343-355.
  • Lapham SC, Gruenwald PJ, Remer L, Layne L. New Mexico’s 1998 driveup liquor window closure. Study I: Effect on alcohol involved crashes. Addiction. 2004;99(5):598-606.
  • Miller T, Snowden C, Birckmayer J, Hendrie D. Retail alcohol monopolies, underage drinking, and youth impaired driving deaths. Accid Anal Prev. 2006;38(6):1162-1167.
  • Montgomery JM, Foley KL, Wolfson M. Enforcing the minimum drinking age: State, local and agency characteristics associated with compliance checks and Cops in Shops programs. Addiction. 2006;101(2):223-231.
  • Reynolds RI, Holder HD, Gruenewald PJ. Community prevention and alcohol retail access. Addiction. 1997;92 Suppl 2:S261-S272.
  • Treno AJ, Gruenewald PJ, Johnson FW. Alcohol availability and injury: The role of local outlet densities.  Alcohol Clin Exp Res. 2001;25(10):1467-1471.
  • Treno AJ, Gruenewald PJ, Wood DS, Ponicki WR. The price of alcohol: A consideration of contextual factors. Alcohol Clin Exp Res. 2006;30(10):1734-1742.
  • Treno AJ, Grube JW, Martin SE. Alcohol availability as a predictor of youth drinking and driving: A hierarchical analysis of survey and archival data. Alcohol Clin Exp Res. 2003;27(5):835-840.

 

Automobile Industry

  • Devaraj S, Matta KF, Conlon E.  Product and Service Quality: The Antecedents of Customer Loyalty in the Automotive Industry. Production and Operations Management.  2001; 10(4): 424-439.
  • Hellinga LA, McCartt AT, Haire ER. Choice of teenagers’ vehicles and views on vehicle safety: Survey of parents of novice teenage drivers. J Safety Res.2007;38(6):707-713.
  • Joetan E, Kleiner BH. Incentive practices in the US automobile industry. Management Research News. 2004;27(7):49–62.
  • Koppel S, Charlton J, Fildes B, Fitzharris M. How important is vehicle safety in the new vehicle purchase process? Accid Anal Prev. 2008;40(3):994-1004.
  • Koppel S, Charlton J, Fildes B. How important is vehicle safety in the new vehicle purchase/lease process for fleet vehicles? Traffic Inj Prev. 2007;8(2):130-136.
  • Van Alst JW.  Fueling Fair Practices: A Road Map to Improved Public Policy for Used Car Sales and Financing, National Consumer Law Center, (March 5, 2008), Available at http://www.nclc.org/issues/auto/content/report-fuelingfairpractices0309.pdf.

 

Firearms Industry

  • Cook, PJ, Molliconi S, Cole, TB.Regulating gun markets. The Journal of Criminal Law and Criminology. 1995;86(1):59-92.
  • Lewin NL, Vernick JS, Beilenson PL, Mair JS, Lindamood MM, Teret SP, Webster DW. The Baltimore Youth Ammunition Initiative: A model application of local public health authority in preventing gun violence. Am J Public Health. 2005;95(5):762-765.
  • Miller M, Azrael D, Hemenway D. Firearm availability and unintentional deaths, suicide, and homicide among 5-14 year olds. The Journal of Trauma. 2002;52(2):267-275.
  • Miller M, Azrael D, Hemenway D. Firearm availability and unintentional deaths. Accident Analysis and Prevention. 2001;33:477-484.
  • Miller M, Azrael D, Hemenway D. Firearm availability and unintentional deaths, suicide, and homicide among women. Journal of Urban Health. 2002; 79(1):26-38.
  • Sorenson SB, Berk RA. Handgun sales, beer sales, and youth homicide, California 1972-1993. Journal of Public Health Policy. 2001;22(2):182-197.
  • Vernick JS, Mair JS. How the law affects gun policy in the United States: Law as intervention or obstacle to prevention. J Law Med Ethics. 2002;30(4):692-704.
  • Vernick JS, Webster DW, Bulzacchelli MT, Mair JS. Regulation of firearm dealers in the United States: An analysis of state law and opportunities for improvement. J Law Med Ethics. 2006;34(4):765-775.
  • Webster DW, Vernick JS, Buzacchelli MT. Effects of a gun dealer’s change in sales practices on the supply of guns to criminals. The Journal of Urban Health. 2006; 83(5):778-787.
  • Webster DW, Bulzacchelli MT, Zeoli AM, Vernick JS. Effects of undercover police stings of gun dealers on the supply of new guns to criminals. Inj Prev. 2006;12(4):225-230.
  • Webster DW, Vernick JS, Bulzacchelli MT. Effects of state-level firearm seller accountability policies on firearm trafficking. J Urban Health. 2009;86(4):525-537.
  • Webster DW, Vernick JS, Hepburn LM. Relationship between licensing, registration, and other gun sales laws and the source state of crime guns. Inj Prev. 2001;7(3):184-189.
  • Wintemute GJ. Where the guns come from: The gun industry and gun commerce. The Future of Children. 2003;12(2):55-71.

 

Food and Beverage Industry

  • Altekruse SF, Yang S, Timbo BB, Angulo FJ. A multi-state survey of consumer food-handling and food-consumption practices. Am J Prev Med. 1999;16(3):216-221.
  • Angell SY, Silver LD, Goldstein GP, Johnson CM, Deitcher DR, Frieden TR, Bassett MT. Cholesterol control beyond the clinic: New York City’s trans fat restriction. Ann Intern Med. 2009;151(2):129-134.
  • Austin SB, Melly SJ, Sanchez BN, Patel A, Buka S, Gortmaker SL. Clustering of fast food restaurants around schools: A novel application of spatial statistics to the study of food environments. Am J Public Health. 2005;95(9):1575-1581.
  • Baker EA, Schootman M, Barnidge E, Kelly C. The role of race and poverty in access to foods that enable individuals to adhere to dietary guidelines. Prev Chronic Dis. 2006;3(3):A76.
  • Borgmeier I, Westenhoefer J. Impact of different food label formats on healthiness evaluation and food choice of consumers: A randomized-controlled study. BMC Public Health. 2009;12(9):184.
  • Burton S, Creyer EH, Kees J, Huggins K. Attacking the obesity epidemic: the potential health benefits of providing nutrition information in restaurants. Am J Public Health.2006;96(9):1669-1675.
  • Cassady D, Housemann R, Dagher C. Measuring cues for healthy choices on restaurant menus: Development and testing of a measurement instrument. Am J Health Promot. 2004;18(6):444-449.
  • Creel JS, Sharkey JR, McIntosh A, Anding J, Huber JC Jr. Availability of healthier options in traditional and nontraditional rural fast-food outlets. BMC Public Health. 2008;8:395.
  • Dumanovsky T, Nonas CA, Huang CY, Silver LD, Bassett MT. What people buy from fast-food restaurants: Caloric content and menu item selection, New York City 2007. Obesity (Silver Spring). 2009; 17(7):1369-1374.
  • Dwyer JJ, Macaskill LA, Uetrecht CL, Dombrow C. Eat Smart! Ontario’s Healthy Restaurant Program: Focus groups with non-participating restaurant operators. Can J Diet Pract Res. 2004.;65(1):6-9.
  • Economos CD, Folta SC, Goldberg J, Hudson D, Collins J, Baker Z, Lawson E, Nelson M. A community-based restaurant initiative to increase availability of healthy menu options in Somerville, Massachusetts: Shape Up Somerville. Prev Chronic Dis. 2009.;6(3):A102
  • Fielding JE, Aguirre A, Palaiologos E. Effectiveness of altered incentives in a food safety inspection program. Prev Med. 2001;32(3):239-244.
  • Ford PB, Dzewaltowski DA. Disparities in obesity prevalence due to variation in the retail food environment: Three testable hypotheses. Nutr Rev. 2008 Apr;66(4):216-228.
  • French SA, Harnack L, Jeffery RW. Fast food restaurant use among women in the Pound of Prevention study: Dietary, behavioral and demographic correlates. International Journal of Obesity & Related Metabolic Disorders. 2000;24(1):1353.
  • French SA. Pricing effects on food choices. J.Nutr. 2003;133(3):841S-843S.
  • French SA, Jeffery RW, Story M, Breitlow KK, Baxter JS, Hannan P, et al. Pricing and promotion effects on lowfat vending snack purchases: The CHIPS Study. Am J Public Health. 2001 ;91(1):112-117.
  • French SA, Story M, Neumark Sztainer D, Fulkerson JA, Hannan P. Fast food restaurant use among adolescents: Associations with nutrient intake, food choices and behavioral and psychosocial variables. Int J Obes Relat Metab Disord. 2001;25(12):1823-1833.
  • Fried EJ, Nestle M. The growing political movement against soft drinks in schools. JAMA.2002 ;288(1):2181-2181.
  • Gerend MA. Does calorie information promote lower calorie fast food choices among college students? J Adolesc Health. 2009;44(1):84-86.
  • Glanz K, Resnicow K, Seymour J, Hoy K, Stewart H, Lyons M, Goldberg J. How major restaurant chains plan their menus: The role of profit, demand, and health. Am J Prev Med. 2007;32(5):383-388.
  • Hannan P, French SA, Story M, Fulkerson JA. A pricing strategy to promote sales of lower fat foods in high school cafeterias: Acceptability and sensitivity analysis. Am.J.Health Promot. 2002 ;17(1):16,ii.
  • Hanni KD, Garcia E, Ellemberg C, Winkleby M. Targeting the taqueria: Implementing healthy food options at Mexican American restaurants. Health Promot Pract. 2009;10(2 Suppl):91S-99S.
  • Harnack LJ, French SA. Effect of point-of-purchase calorie labeling on restaurant and cafeteria food choices: A review of the literature. Int J Behav Nutr Phys Act. 2008 Oct 26;5:51.
  • Harnack LJ, French SA, Oakes JM, Story MT, Jeffery RW, Rydell SA. Effects of calorie labeling and value size pricing on fast food meal choices: Results from an experimental trial. Int J Behav Nutr Phys Act. 2008 ;5:63.
  • Jacobson MF, Brownell KD. Small taxes on soft drinks and snack foods to promote health. Am J Public Health 2000;90:854-857.
  • Jetter KM, Cassady DL. Increasing fresh fruit and vegetable availability in a low-income neighborhood convenience store: A pilot study. Health Promot Pract. 2009 Feb 12. [Epub ahead of print]
  • Kim D, Kawachi I. Food taxation and pricing strategies to “thin out” the obesity epidemic.  Am. J. Prev. Med. 2006;30(5):430-437.
  • Kimathi AN, Gregoire MB, Dowling RA, Stone MK. A healthful options food station can improve satisfaction and generate gross profit in a worksite cafeteria. J Am Diet Assoc. 2009;109(5):914-917.
  • Kuo T, Jarosz CJ, Simon P, Fielding JE. Menu labeling as a potential strategy for combating the obesity epidemic: A health impact assessment. Am J Public Health. 2009;99(9):1680-1686.
  • Kwate N O A. Fried chicken and fresh apples: Racial segregation as a fundamental cause of fast food density in black neighborhoods. Health and Place. 2008;14:32-44.
  • Kwate NO, Yau CY, Loh JM, Williams D. Inequality in obesigenic environments: Fast food density in New York City. Healthand Place. 2009;15(1):364-73
  • Lang T, Rayner G, Kaelin E. The Food Industry, Diet, Physical Activity and Health: A Review Of Reported Commitments And Practice Of 25 Of The World’s Largest Food Companies. 2006.
  • Larson NI, Story MT, Nelson MC. Neighborhood environments: Disparities in access to healthy foods in the U.S. Am J Prev Med. 2009;36(1):74-81.
  • Ludwig DS, Brownell KD. Public health action amid scientific uncertainty: The case of restaurant calorie labeling regulations. JAMA. 2009;302(4):434-435.
  • Lynch RA, Elledge BL, Griffith CC, Boatright DT. A comparison of food safety knowledge among restaurant managers, by source of training and experience, in Oklahoma County, Oklahoma. J Environ Health. 2003;66(2):9-14, 26.
  • Macdonald L, Cummins S, Macintyre S. Neighbourhood fast food environment and area deprivation-substitution or concentration? Appetite. 2007l;49(1):251-254.
  • Maddock J. The relationship between obesity and the prevalence of fast food restaurants: State level analysis. Am J Health Promot. 2004;19(2):137-143.
  • Mashta O. UK firms sign up to display calories on menus. BMJ. 2009;338:b182.
  • Morland KB, Evenson KR. Obesity prevalence and the local food environment.  Health and Place. 2009; 15(2):491-495
  • Nielsen SJ, Siega Riz AM, Popkin BM. Trends in food locations and sources among adolescents and young adults. Prev Med. 2002;35(2):107-113.
  • O’Dougherty M, Harnack LJ, French SA, Story M, Oakes JM, Jeffery RW. Nutrition labeling and value size pricing at fast-food restaurants: A consumer perspective. Am J Health Promot. 2006;20(4):247-250.
  • Phillips ML, Elledge BL, Basara HG, Lynch RA, Boatright DT. Recurrent critical violations of the food code in retail food service establishments. J Environ Health. 2006;68(10):24-30, 55.
  • Pomeranz JL, Brownell KD. Legal and public health considerations affecting  the success, reach, and impact of menu-labeling laws. Am J Public Health. 2008;98(9):1578-1583.
  • Roberto CA, Agnew H, Brownell KD. An observational study of consumers’ accessing of nutrition information in chain restaurants. Am J Public Health. 2009;99(5):820-821.
  • Rose D, Hutchinson PL, Bodor JN, Swalm CM, Farley TA, Cohen DA, Rice JC. Neighborhood food environments and Body Mass Index: The importance of in-store contents. Am J Prev Med. 2009;37(3):214-219.
  • Rydell SA, Harnack LJ, Oakes JM, Story M, Jeffery RW, French SA. Why eat at fast-food restaurants: reported reasons among frequent consumers. J Am Diet Assoc. 2008;108(12):2066-2070.
  • Sharkey JR, Horel S, Han D, Huber JC Jr. Association between neighborhood need and spatial access to food stores and fast food restaurants in neighborhoods of colonias. Int J Health Geogr. 2009;8:9.
  • Song HJ, Gittelsohn J, Kim M, Suratkar S, Sharma S, Anliker J. A corner store intervention in a low-income urban community is associated with increased availability and sales of some healthy foods. Public Health Nutr. 2009:1-8.
  • Spencer EH, Frank E, McIntosh NF. Potential effects of the next 100 billion hamburgers sold by McDonald’s. Am.J.Prev.Med. 2005 ;28(4):379-381.
  • Story M, Kaphingst KM, Robinson-O’Brien R, Glanz K. Creating healthy food and eating environments: Policy and environmental approaches. Annu Rev Public Health. 2008;29:253-72.

 

Pharmaceutical Industry

  • Brooks JM, Doucette WR, Wan S, Klepser DG. Retail pharmacy market structure and performance. Inquiry. 2008;45(1):75-88.
  • Carroll NV. Estimating the impact of Medicare part D on the profitability of independent community pharmacies. J Manag Care Pharm. 2008;14(8):768-779.
  • Fincham JE. An unfortunate and avoidable component of American pharmacy: Tobacco. Am J Pharm Educ. 2008;72(3):57
  • Garattini L, Motterlini N, Cornago D. Prices and distribution margins of in-patent drugs in pharmacy: A comparison in seven European countries. Health Policy. 2008;85(3):305-313.
  • Gellad WF, Choudhry NK, Friedberg MW, Brookhart MA, Haas JS, Shrank WH. Variation in drug prices at pharmacies: Are prices higher in poorer areas? Health Serv Res. 2009;44(2 Pt 1):606-617.
  • Gitlin M, Wilson L. Repackaged pharmaceuticals in the California workers’ compensation system: From distribution and pricing options to physician and retail dispensing. Am J Ind Med. 2007;50(4):303-315.
  • Montoya ID, Jano E. Online pharmacies: Safety and regulatory considerations. Int J Health Serv. 2007;37(2):279-289.
  • Retail and mail copayments on the rise. Manag Care. 2009;18(6):50.
  • Rudholm N. Entry of new pharmacies in the deregulated Norwegian pharmaceuticals market– consequences for costs and availability. Health Policy.2008;87(2):258-263
  • Stafford E. Pharmacy initiatives target prescription drug costs. J Mich Dent Assoc. 2008;90(9):22.
  • Stevenson FA, Leontowitsch M, Duggan C. Over-the-counter medicines: Professional expertise and consumer discourses. Sociol Health Illn. 2008;30(6):913-928.

 

Tobacco Industry

  • Andersen BS, Begay ME, Lawson CB. Breaking the alliance: Defeating the tobacco industry’s allies and enacting youth access restrictions in Massachusetts. Am J Public Health. 2003;93(11):1922-1928.
  • Celebucki CC, Diskin K. A longitudinal study of externally visible cigarette advertising on retail storefronts in Massachusetts before and after the Master Settlement Agreement. Tob Control. 2002;11 Suppl 2:ii47-53.
  • Chriqui JF, Ribisl KM, Wallace RM, Williams RS, O’Connor JC, el Arculli R. A comprehensive review of state laws governing Internet and other delivery sales of cigarettes in the United States. Nicotine Tob Res. 2008;10(2):253-265.
  • Feighery EC, Ribisl KM, Achabal DD, Tyebjee T. Retail trade incentives: How tobacco industry practices compare with those of other industries. Am J Public Health. 1999;89(10):1564-1566.
  • Feighery EC, Ribisl KM, Clark PI, Haladjian HH. How tobacco companies ensure prime placement of their advertising and products in stores: Interviews with retailers about tobacco company incentive programmes. Tob Control. 2003;12(2):184-188.
  • Feighery EC, Ribisl KM, Schleicher N, Lee RE, Halvorson S. Cigarette advertising and promotional strategies in retail outlets: results of a statewide survey in California. Tob Control. 2001;10(2):184-188.
  • Feighery EC, Ribisl KM, Schleicher NC, Clark PI. Retailer participation in cigarette company incentive programs is related to increased levels of cigarette advertising and cheaper cigarette prices in stores. Prev Med. 2004;38(6):876-884.
  • Gilbertson T. Retail point-of-sale guardianship and juvenile tobacco purchases: assessing the prevention capabilities of undergraduate college students. J Drug Educ. 2007;37(1):1-30.
  • Gilpin EA, White VM, Pierce JP. How effective are tobacco industry bar and club marketing efforts in reaching young adults? Tob Control. 2005;14(3):186-192.
  • Glanz K, Sutton NM, Jacob Arriola KR. Operation storefront Hawaii: Tobacco advertising and promotion in Hawaii stores. J Health Commun. 2006;11(7):699-707.
  • Henriksen L, Feighery EC, Schleicher NC, Cowling DW, Kline RS, Fortmann SP. Is adolescent smoking related to the density and proximity of tobacco outlets and retail cigarette advertising near schools? Prev Med. 2008;47(2):210-4.
  • Henriksen L, Feighery EC, Schleicher NC, Haladjian HH, Fortmann SP. Reaching youth at the point of sale: cigarette marketing is more prevalent in stores where adolescents shop frequently. Tob Control. 2004;13(3):315-318.
  • Henriksen L, Feighery EC, Wang Y, Fortmann SP. Association of retail tobacco marketing with adolescent smoking. Am J Public Health. 2004;94(12):2081-2083.
  • Lavack AM, Toth G. Tobacco point-of-purchase promotion: Examining tobacco industry documents. Tob Control. 2006;15(5):377-384.
  • Loomis BR, Farrelly MC, Mann NH. The association of retail promotions for cigarettes with the Master Settlement Agreement, tobacco control programmes and cigarette excise taxes. Tob Control. 2006;15(6):458-463.
  • Loomis BR, Farrelly MC, Nonnemaker JM, Mann NH. Point of purchase cigarette promotions before and after the Master Settlement Agreement: exploring retail scanner data. Tob Control. 2006;15(2):140-
  • Pollay RW. More than meets the eye: on the importance of retail cigarette merchandising. Tob Control. 2007;16(4):270-274.
  • Sepe E, Ling PM, Glantz SA. Smooth moves: bar and nightclub tobacco promotions that target young adults. Am J Public Health. 2002;92(3):414-419.
  • Slater S, Chaloupka FJ, Wakefield M. State variation in retail promotions and advertising for Marlboro cigarettes. Tob Control. 2001;10(4):337-339.
  • Slater S, Giovino G, Chaloupka F. Surveillance of tobacco industry retail marketing activities of reduced harm products. Nicotine Tob Res. 2008;10(1):187-193.
  • Slater SJ, Chaloupka FJ, Wakefield M, Johnston LD, O’malley PM. The impact of retail cigarette marketing practices on youth smoking uptake. Arch Pediatr Adolesc. Med. 2007;161(5):440-445.
  • Slater SJ, Chaloupka FJ, Wakefield M, Johnston LD, O’Malley PM. The impact of retail cigarette marketing practices on youth smoking uptake. Arch Pediatr Adolesc Med. 2007;161(5):440-445.
  • Smith EA, Blackman VS, Malone RE. Death at a discount: how the tobacco industry thwarted tobacco control policies in US military commissaries. Tob Control. 2007;16(1):38-46.

 

Studies of Multiple Industries

  • Ashe M, Jernigan D, Kline R, Galaz R. Land use planning and the control of alcohol, tobacco, firearms, and fast food restaurants. Am J Public Health. 2003;93(9):1404-1408.
  • Feighery EC, Ribisl KM, Achabal DD, Tyebjee T. Retail trade incentives: how tobacco industry practices compare with those of other industries. Am J Public Health. 1999;89(10):1564-1566.
  • Freudenberg N, Galea S, Fahs M. Changing corporate practices to reduce cancer disparities. J Health Care Poor Underserved. 2008; 19(1):26-40.
  • Hemenway D. The public health approach to motor vehicles, tobacco, and alcohol, with applications to firearms policy. J Public Health Policy. 2001;22(4):381-402.
  • Kotecki JE. Sale of alcohol in pharmacies: results and implications of an empirical study. J Community Health. 2003;28(1):65-77.

Selected Bibliography on Retail Practices and Health by Industry

Posted on by Corporations and Health Watch

Selected Bibliography on Retail Practices and Health in the Alcohol, Automobile, Firearms, Food and Beverage, Pharmaceutical, and Tobacco industries.

Alcohol Industry

Cohen DA, GhoshDastidar B, Scribner R, Miu A, Scott M, Robinson P, et al. Alcohol outlets, gonorrhea, and the Los Angeles civil unrest: A longitudinal analysis. Soc Sci Med. 2006;62(12):3062-3071.

Gruenewald PJ, Freisthler B, Remer L, Lascala EA, Treno A. Ecological models of alcohol outlets and violent assaults: Crime potentials and geospatial analysis. Addiction. 2006;101(5):666-677.

Gruenewald PJ, Johnson FW, Treno AJ. Outlets, drinking and driving: A multilevel analysis of availability. Stud Alcoho. 2002;63(4):460-468.

Gruenewald PJ, Millar AB, Treno AJ, Yang Z, Ponicki WR, Roeper P. The geography of availability and driving after drinking.Addiction. 1996;91(7):967-983.

Kotecki JE, Fowler JB, German TC, Stephenson SL, Warnick T. Kentucky pharmacists’ opinions and practices related to the sale of cigarettes and alcohol in pharmacies. J Community Health. 2000;25(4):343-355.

Lapham SC, Gruenwald PJ, Remer L, Layne L. New Mexico’s 1998 driveup liquor window closure. Study I: Effect on alcohol involved crashes. Addiction. 2004;99(5):598-606.

Miller T, Snowden C, Birckmayer J, Hendrie D. Retail alcohol monopolies, underage drinking, and youth impaired driving deaths. Accid Anal Prev. 2006;38(6):1162-1167.

Montgomery JM, Foley KL, Wolfson M. Enforcing the minimum drinking age: State, local and agency characteristics associated with compliance checks and Cops in Shops programs. Addiction. 2006;101(2):223-231.

Reynolds RI, Holder HD, Gruenewald PJ. Community prevention and alcohol retail access. Addiction. 1997;92 Suppl 2:S261-S272.

Treno AJ, Gruenewald PJ, Johnson FW. Alcohol availability and injury: The role of local outlet densities.  Alcohol Clin Exp Res. 2001;25(10):1467-1471.

Treno AJ, Gruenewald PJ, Wood DS, Ponicki WR. The price of alcohol: A consideration of contextual factors. Alcohol Clin Exp Res. 2006;30(10):1734-1742.

Treno AJ, Grube JW, Martin SE. Alcohol availability as a predictor of youth drinking and driving: A hierarchical analysis of survey and archival data. Alcohol Clin Exp Res. 2003;27(5):835-840.

 

Automobile Industry

Devaraj S, Matta KF, Conlon E.  Product and Service Quality: The Antecedents of Customer Loyalty in the Automotive Industry.Production and Operations Management.  2001; 10(4): 424-439.

Hellinga LA, McCartt AT, Haire ER. Choice of teenagers’ vehicles and views on vehicle safety: Survey of parents of novice teenage drivers. J Safety Res.2007;38(6):707-713.

Joetan E, Kleiner BH. Incentive practices in the US automobile industry. Management Research News. 2004;27(7):49–62.

Koppel S, Charlton J, Fildes B, Fitzharris M. How important is vehicle safety in the new vehicle purchase process? Accid Anal Prev. 2008;40(3):994-1004.

Koppel S, Charlton J, Fildes B. How important is vehicle safety in the new vehicle purchase/lease process for fleet vehicles?Traffic Inj Prev. 2007;8(2):130-136.

Van Alst JW.  Fueling Fair Practices: A Road Map to Improved Public Policy for Used Car Sales and Financing, National Consumer Law Center, (March 5, 2008), Available at http://www.nclc.org/issues/auto/content/report-fuelingfairpractices0309.pdf.

 

Firearms Industry

Cook, PJ, Molliconi S, Cole, TB.Regulating gun markets. The Journal of Criminal Law and Criminology. 1995;86(1):59-92.

Lewin NL, Vernick JS, Beilenson PL, Mair JS, Lindamood MM, Teret SP, Webster DW. The Baltimore Youth Ammunition Initiative: A model application of local public health authority in preventing gun violence. Am J Public Health. 2005;95(5):762-765.

Miller M, Azrael D, Hemenway D. Firearm availability and unintentional deaths, suicide, and homicide among 5-14 year olds. The Journal of Trauma. 2002;52(2):267-275.

Miller M, Azrael D, Hemenway D. Firearm availability and unintentional deaths. Accident Analysis and Prevention. 2001;33:477-484.

Miller M, Azrael D, Hemenway D. Firearm availability and unintentional deaths, suicide, and homicide among women.Journal of Urban Health. 2002; 79(1):26-38.

Sorenson SB, Berk RA. Handgun sales, beer sales, and youth homicide, California 1972-1993. Journal of Public Health Policy. 2001;22(2):182-197.

Vernick JS, Mair JS. How the law affects gun policy in the United States: Law as intervention or obstacle to prevention. J Law Med Ethics. 2002;30(4):692-704.

Vernick JS, Webster DW, Bulzacchelli MT, Mair JS. Regulation of firearm dealers in the United States: An analysis of state law and opportunities for improvement. J Law Med Ethics. 2006;34(4):765-775.

Webster DW, Vernick JS, Buzacchelli MT. Effects of a gun dealer’s change in sales practices on the supply of guns to criminals. The Journal of Urban Health. 2006; 83(5):778-787.

Webster DW, Bulzacchelli MT, Zeoli AM, Vernick JS. Effects of undercover police stings of gun dealers on the supply of new guns to criminals. Inj Prev. 2006;12(4):225-230.

Webster DW, Vernick JS, Bulzacchelli MT. Effects of state-level firearm seller accountability policies on firearm trafficking. J Urban Health. 2009;86(4):525-537.

Webster DW, Vernick JS, Hepburn LM. Relationship between licensing, registration, and other gun sales laws and the source state of crime guns. Inj Prev. 2001;7(3):184-189.

Wintemute GJ. Where the guns come from: The gun industry and gun commerce. The Future of Children. 2003;12(2):55-71.

 

Food and Beverage Industry

Altekruse SF, Yang S, Timbo BB, Angulo FJ. A multi-state survey of consumer food-handling and food-consumption practices.Am J Prev Med. 1999;16(3):216-221.

Angell SY, Silver LD, Goldstein GP, Johnson CM, Deitcher DR, Frieden TR, Bassett MT. Cholesterol control beyond the clinic: New York City’s trans fat restriction. Ann Intern Med. 2009;151(2):129-134.

Austin SB, Melly SJ, Sanchez BN, Patel A, Buka S, Gortmaker SL. Clustering of fast food restaurants around schools: A novel application of spatial statistics to the study of food environments. Am J Public Health. 2005;95(9):1575-1581.

Baker EA, Schootman M, Barnidge E, Kelly C. The role of race and poverty in access to foods that enable individuals to adhere to dietary guidelines. Prev Chronic Dis. 2006;3(3):A76.

Borgmeier I, Westenhoefer J. Impact of different food label formats on healthiness evaluation and food choice of consumers: A randomized-controlled study. BMC Public Health. 2009;12(9):184.

Burton S, Creyer EH, Kees J, Huggins K. Attacking the obesity epidemic: the potential health benefits of providing nutrition information in restaurants. Am J Public Health.2006;96(9):1669-1675.

Cassady D, Housemann R, Dagher C. Measuring cues for healthy choices on restaurant menus: Development and testing of a measurement instrument. Am J Health Promot. 2004;18(6):444-449.

Creel JS, Sharkey JR, McIntosh A, Anding J, Huber JC Jr. Availability of healthier options in traditional and nontraditional rural fast-food outlets. BMC Public Health. 2008;8:395.

Dumanovsky T, Nonas CA, Huang CY, Silver LD, Bassett MT. What people buy from fast-food restaurants: Caloric content and menu item selection, New York City 2007. Obesity (Silver Spring). 2009; 17(7):1369-1374.

Dwyer JJ, Macaskill LA, Uetrecht CL, Dombrow C. Eat Smart! Ontario’s Healthy Restaurant Program: Focus groups with non-participating restaurant operators. Can J Diet Pract Res. 2004.;65(1):6-9.

Economos CD, Folta SC, Goldberg J, Hudson D, Collins J, Baker Z, Lawson E, Nelson M. A community-based restaurant initiative to increase availability of healthy menu options in Somerville, Massachusetts: Shape Up Somerville. Prev Chronic Dis. 2009.;6(3):A102

Fielding JE, Aguirre A, Palaiologos E. Effectiveness of altered incentives in a food safety inspection program. Prev Med. 2001;32(3):239-244.

Ford PB, Dzewaltowski DA. Disparities in obesity prevalence due to variation in the retail food environment: Three testable hypotheses. Nutr Rev. 2008 Apr;66(4):216-228.

French SA, Harnack L, Jeffery RW. Fast food restaurant use among women in the Pound of Prevention study: Dietary, behavioral and demographic correlates. International Journal of Obesity & Related Metabolic Disorders. 2000;24(1):1353.

French SA. Pricing effects on food choices. J.Nutr. 2003;133(3):841S-843S.

French SA, Jeffery RW, Story M, Breitlow KK, Baxter JS, Hannan P, et al. Pricing and promotion effects on lowfat vending snack purchases: The CHIPS Study. Am J Public Health. 2001 ;91(1):112-117.

French SA, Story M, Neumark Sztainer D, Fulkerson JA, Hannan P. Fast food restaurant use among adolescents: Associations with nutrient intake, food choices and behavioral and psychosocial variables. Int J Obes Relat Metab Disord.2001;25(12):1823-1833.

Fried EJ, Nestle M. The growing political movement against soft drinks in schools. JAMA.2002 ;288(1):2181-2181.

Gerend MA. Does calorie information promote lower calorie fast food choices among college students? J Adolesc Health. 2009;44(1):84-86.

Glanz K, Resnicow K, Seymour J, Hoy K, Stewart H, Lyons M, Goldberg J. How major restaurant chains plan their menus: The role of profit, demand, and health. Am J Prev Med. 2007;32(5):383-388.

Hannan P, French SA, Story M, Fulkerson JA. A pricing strategy to promote sales of lower fat foods in high school cafeterias: Acceptability and sensitivity analysis. Am.J.Health Promot. 2002 ;17(1):16,ii.

Hanni KD, Garcia E, Ellemberg C, Winkleby M. Targeting the taqueria: Implementing healthy food options at Mexican American restaurants. Health Promot Pract. 2009;10(2 Suppl):91S-99S.

Harnack LJ, French SA. Effect of point-of-purchase calorie labeling on restaurant and cafeteria food choices: A review of the literature. Int J Behav Nutr Phys Act. 2008 Oct 26;5:51.

Harnack LJ, French SA, Oakes JM, Story MT, Jeffery RW, Rydell SA. Effects of calorie labeling and value size pricing on fast food meal choices: Results from an experimental trial. Int J Behav Nutr Phys Act. 2008 ;5:63.

Jacobson MF, Brownell KD. Small taxes on soft drinks and snack foods to promote health. Am J Public Health 2000;90:854-857.

Jetter KM, Cassady DL. Increasing fresh fruit and vegetable availability in a low-income neighborhood convenience store: A pilot study. Health Promot Pract. 2009 Feb 12. [Epub ahead of print]

Kim D, Kawachi I. Food taxation and pricing strategies to “thin out” the obesity epidemic.  Am. J. Prev. Med.2006;30(5):430-437.

Kimathi AN, Gregoire MB, Dowling RA, Stone MK. A healthful options food station can improve satisfaction and generate gross profit in a worksite cafeteria. J Am Diet Assoc. 2009;109(5):914-917.

Kuo T, Jarosz CJ, Simon P, Fielding JE. Menu labeling as a potential strategy for combating the obesity epidemic: A health impact assessment. Am J Public Health. 2009;99(9):1680-1686.

Kwate N O A. Fried chicken and fresh apples: Racial segregation as a fundamental cause of fast food density in black neighborhoods. Health and Place. 2008;14:32-44.

Kwate NO, Yau CY, Loh JM, Williams D. Inequality in obesigenic environments: Fast food density in New York City.Healthand Place. 2009;15(1):364-73

Lang T, Rayner G, Kaelin E. The Food Industry, Diet, Physical Activity and Health: A Review Of Reported Commitments And Practice Of 25 Of The World’s Largest Food Companies. 2006.

Larson NI, Story MT, Nelson MC. Neighborhood environments: Disparities in access to healthy foods in the U.S. Am J Prev Med. 2009;36(1):74-81.

Ludwig DS, Brownell KD. Public health action amid scientific uncertainty: The case of restaurant calorie labeling regulations.JAMA. 2009;302(4):434-435.

Lynch RA, Elledge BL, Griffith CC, Boatright DT. A comparison of food safety knowledge among restaurant managers, by source of training and experience, in Oklahoma County, Oklahoma. J Environ Health. 2003;66(2):9-14, 26.

Macdonald L, Cummins S, Macintyre S. Neighbourhood fast food environment and area deprivation-substitution or concentration? Appetite. 2007l;49(1):251-254.

Maddock J. The relationship between obesity and the prevalence of fast food restaurants: State level analysis. Am J Health Promot. 2004;19(2):137-143.

Mashta O. UK firms sign up to display calories on menus. BMJ. 2009;338:b182.

Morland KB, Evenson KR. Obesity prevalence and the local food environment.  Health and Place. 2009; 15(2):491-495

Nielsen SJ, Siega Riz AM, Popkin BM. Trends in food locations and sources among adolescents and young adults. Prev Med.2002;35(2):107-113.

O’Dougherty M, Harnack LJ, French SA, Story M, Oakes JM, Jeffery RW. Nutrition labeling and value size pricing at fast-food restaurants: A consumer perspective. Am J Health Promot. 2006;20(4):247-250.

Phillips ML, Elledge BL, Basara HG, Lynch RA, Boatright DT. Recurrent critical violations of the food code in retail food service establishments. J Environ Health. 2006;68(10):24-30, 55.

Pomeranz JL, Brownell KD. Legal and public health considerations affecting  the success, reach, and impact of menu-labeling laws. Am J Public Health. 2008;98(9):1578-1583.

Roberto CA, Agnew H, Brownell KD. An observational study of consumers’ accessing of nutrition information in chain restaurants. Am J Public Health. 2009;99(5):820-821.

Rose D, Hutchinson PL, Bodor JN, Swalm CM, Farley TA, Cohen DA, Rice JC. Neighborhood food environments and Body Mass Index: The importance of in-store contents. Am J Prev Med. 2009;37(3):214-219.

Rydell SA, Harnack LJ, Oakes JM, Story M, Jeffery RW, French SA. Why eat at fast-food restaurants: reported reasons among frequent consumers. J Am Diet Assoc. 2008;108(12):2066-2070.

Sharkey JR, Horel S, Han D, Huber JC Jr. Association between neighborhood need and spatial access to food stores and fast food restaurants in neighborhoods of colonias. Int J Health Geogr. 2009;8:9.

Song HJ, Gittelsohn J, Kim M, Suratkar S, Sharma S, Anliker J. A corner store intervention in a low-income urban community is associated with increased availability and sales of some healthy foods. Public Health Nutr. 2009:1-8.

Spencer EH, Frank E, McIntosh NF. Potential effects of the next 100 billion hamburgers sold by McDonald’s.Am.J.Prev.Med. 2005 ;28(4):379-381.

Story M, Kaphingst KM, Robinson-O’Brien R, Glanz K. Creating healthy food and eating environments: Policy and environmental approaches. Annu Rev Public Health. 2008;29:253-72.

 

Pharmaceutical Industry

Brooks JM, Doucette WR, Wan S, Klepser DG. Retail pharmacy market structure and performance. Inquiry. 2008;45(1):75-88.

Carroll NV. Estimating the impact of Medicare part D on the profitability of independent community pharmacies. J Manag Care Pharm. 2008;14(8):768-779.

Fincham JE. An unfortunate and avoidable component of American pharmacy: Tobacco. Am J Pharm Educ. 2008;72(3):57

Garattini L, Motterlini N, Cornago D. Prices and distribution margins of in-patent drugs in pharmacy: A comparison in seven European countries. Health Policy. 2008;85(3):305-313.

Gellad WF, Choudhry NK, Friedberg MW, Brookhart MA, Haas JS, Shrank WH. Variation in drug prices at pharmacies: Are prices higher in poorer areas? Health Serv Res. 2009;44(2 Pt 1):606-617.

Gitlin M, Wilson L. Repackaged pharmaceuticals in the California workers’ compensation system: From distribution and pricing options to physician and retail dispensing. Am J Ind Med. 2007;50(4):303-315.

Montoya ID, Jano E. Online pharmacies: Safety and regulatory considerations. Int J Health Serv. 2007;37(2):279-289.

Retail and mail copayments on the rise. Manag Care. 2009;18(6):50.

Rudholm N. Entry of new pharmacies in the deregulated Norwegian pharmaceuticals market– consequences for costs and availability. Health Policy.2008;87(2):258-263

Stafford E. Pharmacy initiatives target prescription drug costs. J Mich Dent Assoc. 2008;90(9):22.

Stevenson FA, Leontowitsch M, Duggan C. Over-the-counter medicines: Professional expertise and consumer discourses.Sociol Health Illn. 2008;30(6):913-928.

Tobacco Industry

Andersen BS, Begay ME, Lawson CB. Breaking the alliance: Defeating the tobacco industry’s allies and enacting youth access restrictions in Massachusetts. Am J Public Health. 2003;93(11):1922-1928.

Celebucki CC, Diskin K. A longitudinal study of externally visible cigarette advertising on retail storefronts in Massachusetts before and after the Master Settlement Agreement. Tob Control. 2002;11 Suppl 2:ii47-53.

Chriqui JF, Ribisl KM, Wallace RM, Williams RS, O’Connor JC, el Arculli R. A comprehensive review of state laws governing Internet and other delivery sales of cigarettes in the United States. Nicotine Tob Res. 2008;10(2):253-265.

Feighery EC, Ribisl KM, Achabal DD, Tyebjee T. Retail trade incentives: How tobacco industry practices compare with those of other industries. Am J Public Health. 1999;89(10):1564-1566.

Feighery EC, Ribisl KM, Clark PI, Haladjian HH. How tobacco companies ensure prime placement of their advertising and products in stores: Interviews with retailers about tobacco company incentive programmes. Tob Control. 2003;12(2):184-188.

Feighery EC, Ribisl KM, Schleicher N, Lee RE, Halvorson S. Cigarette advertising and promotional strategies in retail outlets: results of a statewide survey in California. Tob Control. 2001;10(2):184-188.

Feighery EC, Ribisl KM, Schleicher NC, Clark PI. Retailer participation in cigarette company incentive programs is related to increased levels of cigarette advertising and cheaper cigarette prices in stores. Prev Med. 2004;38(6):876-884.

Gilbertson T. Retail point-of-sale guardianship and juvenile tobacco purchases: assessing the prevention capabilities of undergraduate college students. J Drug Educ. 2007;37(1):1-30.

Gilpin EA, White VM, Pierce JP. How effective are tobacco industry bar and club marketing efforts in reaching young adults?Tob Control. 2005;14(3):186-192.

Glanz K, Sutton NM, Jacob Arriola KR. Operation storefront Hawaii: Tobacco advertising and promotion in Hawaii stores. J Health Commun. 2006;11(7):699-707.

Henriksen L, Feighery EC, Schleicher NC, Cowling DW, Kline RS, Fortmann SP. Is adolescent smoking related to the density and proximity of tobacco outlets and retail cigarette advertising near schools? Prev Med. 2008;47(2):210-4.

Henriksen L, Feighery EC, Schleicher NC, Haladjian HH, Fortmann SP. Reaching youth at the point of sale: cigarette marketing is more prevalent in stores where adolescents shop frequently. Tob Control. 2004;13(3):315-318.

Henriksen L, Feighery EC, Wang Y, Fortmann SP. Association of retail tobacco marketing with adolescent smoking. Am J Public Health. 2004;94(12):2081-2083.

Lavack AM, Toth G. Tobacco point-of-purchase promotion: Examining tobacco industry documents. Tob Control. 2006;15(5):377-384.

Loomis BR, Farrelly MC, Mann NH. The association of retail promotions for cigarettes with the Master Settlement Agreement, tobacco control programmes and cigarette excise taxes. Tob Control. 2006;15(6):458-463.

Loomis BR, Farrelly MC, Nonnemaker JM, Mann NH. Point of purchase cigarette promotions before and after the Master Settlement Agreement: exploring retail scanner data. Tob Control. 2006;15(2):140-

Pollay RW. More than meets the eye: on the importance of retail cigarette merchandising. Tob Control. 2007;16(4):270-274.

Sepe E, Ling PM, Glantz SA. Smooth moves: bar and nightclub tobacco promotions that target young adults. Am J Public Health. 2002;92(3):414-419.

Slater S, Chaloupka FJ, Wakefield M. State variation in retail promotions and advertising for Marlboro cigarettes. Tob Control. 2001;10(4):337-339.

Slater S, Giovino G, Chaloupka F. Surveillance of tobacco industry retail marketing activities of reduced harm products.Nicotine Tob Res. 2008;10(1):187-193.

Slater SJ, Chaloupka FJ, Wakefield M, Johnston LD, O’malley PM. The impact of retail cigarette marketing practices on youth smoking uptake. Arch Pediatr Adolesc. Med. 2007;161(5):440-445.

Slater SJ, Chaloupka FJ, Wakefield M, Johnston LD, O’Malley PM. The impact of retail cigarette marketing practices on youth smoking uptake. Arch Pediatr Adolesc Med. 2007;161(5):440-445.

Smith EA, Blackman VS, Malone RE. Death at a discount: how the tobacco industry thwarted tobacco control policies in US military commissaries. Tob Control. 2007;16(1):38-46.

 

Studies of Multiple Industries

Ashe M, Jernigan D, Kline R, Galaz R. Land use planning and the control of alcohol, tobacco, firearms, and fast food restaurants. Am J Public Health. 2003;93(9):1404-1408.

Feighery EC, Ribisl KM, Achabal DD, Tyebjee T. Retail trade incentives: how tobacco industry practices compare with those of other industries. Am J Public Health. 1999;89(10):1564-1566.

Freudenberg N, Galea S, Fahs M. Changing corporate practices to reduce cancer disparities. J Health Care Poor Underserved.2008; 19(1):26-40.

Hemenway D. The public health approach to motor vehicles, tobacco, and alcohol, with applications to firearms policy. J Public Health Policy. 2001;22(4):381-402.

Kotecki JE. Sale of alcohol in pharmacies: results and implications of an empirical study. J Community Health. 2003;28(1):65-77.

 
 

Pharma Goes Online; Feds Fail to Follow

Posted on by Corporations and Health Watch

While the fiercest opposition to direct-to-consumer (DTC) advertisements has been to television advertisements, pharmaceutical companies have increasingly turned their attention to online marketing and social media, such as Facebook and YouTube with very little opposition or regulation by the Food and Drug Administration. In this report, CHW explores the reasons for this increased use of online marketing and social media, profiles a few recent examples where online DTC advertisements have raised concerns, and suggest possible future directions for consumer advocates.

Since the Food and Drug Administration (FDA) first relaxed guidelines governing direct-to-consumer (DTC) pharmaceutical advertising in 1997, DTC advertising has increased dramatically, from approximately $1 billion per year in 19971 to $5.4 billion in 2006.2 As a result, physician and advocacy groups and some elected officials have begun to raise questions about the ethics of DTC advertising.3 While the fiercest opposition to DTC advertisements has been to television advertisements, with less opposition, pharmaceutical companies have increasingly turned their attention to online marketing and social media, such as Facebook, YouTube, Sermo (for physicians), and iVillage (for women’s health).4 A recent article in Advertising Age notes that “what might be considered a yawn-worthy move into new and social media is nothing short of a revolution” for the pharmaceutical industry.5 In this report, Corporations and Health Watch explores the reasons for this increased use of online marketing and social media, profiles a few recent examples where online DTC advertisements have raised concerns, and suggest possible future directions for consumer advocates.

Online advertisements and social media challenge our conceptions of DTC advertisements

Some of the largest pharmaceutical companies have challenged common conceptions of DTC communication through the launch of popular blogs, YouTube channels and other forms of online media. For example, Johnson & Johnson’s McNeil Pediatrics unit sponsors an attention-deficit hyperactivity disorder group called “ADHD Moms” on the social media site Facebook,6 where the number of participants has grown to more than 8,200 without any expenditure by the company.1 Johnson & Johnson also hosts a popular blog called “JNJ BTW” where the company seeks to create a space for a “three-dimensional view” of the company and a “conversation” with consumers. Novartis, Boehringer Ingelheim and AstraZeneca all use Twitter to deliver news about their companies, and several firms have launched controversial channels on YouTube to promote their drugs. Pharmaceutical companies also bid for key words such as “cholesterol” in Google and other search engines so that advertisements for their drugs will appear in the sponsored search results, for which the search engine company collects a fee each time someone clicks on the advertisement.7 In addition, contextual advertising on websites offers pharmaceutical companies the opportunity to place banners on websites targeted to visitors to certain websites or to visitors in certain geographic locations.7

Reasons for industry’s increased use of social media and online advertisements

At a time when print advertisements for pharmaceuticals are down 18% and television advertisements are down 4% to $4.4 billion in 2008 (compared to the $4.8 billion spent in 2007),1 online marketing efforts have soared.1, 5 One reason drug makers have turned to online advertising is because it is a relatively inexpensive way to reach targeted audiences. But in addition to being cost-effective, online media communications are less likely to mobilize patient advocates who are critical of DTC advertising.4, 7

Some observers have suggested that the “lower profile” yet highly effective online DTC advertisements might be “simply smart politics” on the part of pharmaceutical companies wishing to avoid attention by members of congress who wish to regulate DTC advertisements.2 Pharmaceutical marketers have taken advantage of the fact that greater numbers of Americans are now seeking health information and support online instead of consulting their physicians.4, 5, 8 Patients are now seeking more interactive communications, and, in an interview with Advertising Age, a relationship-marketing agency CEO said that social media offers the pharmaceutical industry an opportunity to rebuild trust between the consumer and an industry that is often unpopular.5

Recent DTC “success stories”

Several pharmaceutical companies have launched highly successful online marketing communications, and in some ways these companies serve as industry forerunners.5 Here are some examples:

MULTIPLE SCLEROSIS: Patients with chronic conditions often turn to the internet for the support of others with similar concerns and for help in managing chronic conditions.4 Acorda Therapeutics, working with a division of global advertising agency Saatchi & Saatchi launched a community website called iwalkbecause.org in advance of the release of its drug for multiple sclerosis which will not be available until next year.5 According to a Saatchi executive, the community of people with multiple sclerosis is a group that searches for online information “ferociously.” 5

AMBIEN CR: Saatchi also worked on an integrated TV-web campaign for Sanofi-Aventis’ sleep drug Ambien CR.5 The 15-second commercial directed viewers to go to a “microsite” called silenceyourrooster.com with games, videos, and other social-media elements.5 In the first three days, the site received 1 million “hits” and a 2% “clickthrough rate” to the branded site www.ambiencr.com.5

ASTHMA: AstraZeneca launched a YouTube channel called “My Asthma Story” for its asthma drug Symbicort where they invite patients to submit videos about their positive experiences with Symbicort to their website, where consumers “essentially create their own advertisements for the drug.”5

RESTLESS LEGS: In late 2006, GlaxoSmithKline introduced an unbranded and very creative video on YouTube that received over 200,000 views, which led the company to establish its own YouTube channel, GSK Vision.5

Future Issues for advocates and regulators to consider

Overall, the FDA has, until recently, been weak in its response to pharmaceutical companies’ online DTC advertisements. In fact, there are no published guidelines for online pharmaceutical advertising by the FDA Division of Drug Marketing, Advertising, and Communications Research, the organization typically responsible for providing such oversight.5 As noted by a senior VP at the public relations and marketing communications firm Fleishman Hillard, “People are still figuring out how we employ new media, whish is such a completely new paradigm. What [pharmaceutical companies] are doing now is experimenting.” 5 Similarly, Symbicort brand manager for AstraZeneca notes, “The social-media space is still very much a gray area.” 5 Without oversight, controversy has begun to erupt as it did this past January, when a banner ad went online for the emergency contraceptive Plan B. Plan B is marketed by Duramed, a subsidiary of Barr Pharmaceuticals, which was recently acquired by Teva Pharmaceuticals USA.9 The company advertised on the MTV website which is very popular among girls 17 and younger, directing viewers to go to the Plan B website with the tagline “Because the unexpected happens.” 9

Last April, the FDA began to take action with regard to DTC advertising in new media by sending major pharmaceutical companies untitled letters in April asking them to not place misleading ads on search engines such as Google and Yahoo,5 as well as taking action regarding several YouTube videos with misleading pharmaceutical advertising content. For example, the FDA requested that UK drugmaker Shire Pharmaceuticals remove its YouTube video for Adderall XR, which the agency argued was overstating the hyperactivity drug’s effectiveness while omitting relevant information about risks.10 The FDA also began requiring pharmaceutical companies to embed safety and risk information in the videos themselves, rather than providing a link alongside the video advertisements they post.10

As pharmaceutical companies increasingly turn to online media and social marketing to reach consumers, regulatory guidance from the FDA on this “gray area” will be increasingly necessary, as will increased vigilance on the part of consumer advocates and Congressional leaders.

References

1 US DTC Rx advertising falls 8% to $4.4 billion. Pharma Marketletter. April 21, 2009.

2 US Pharma DTC “recession” started in 2006. Pharma Marketletter. December 5, 2008.

3 Douglas J. Wood Reed Smith LLP. Legal issues to watch in 2009. Advertising Age. December 15, 2009.

4 US drugmakers switch marketing approach. Pharma Marketletter. April 25, 2008.

5 Miley M, Thomaselli R. Big Pharma finally taking steps to reach patients with digital media: highly regulated industry slowly mobilizes with blogs, Twitter, YouTube. Advertising Age. May 11, 2009.

6 McNeil Pediatrics, ADHD Moms A Place for Moms of Children with ADHD. Press Release dated July 9, 2008. Available at: http://www.mcneilpediatrics.net/mcneilpediatrics/assets/
60CON08453A_ADHD_Moms_Press_Release_FINAL_FOR_DIST.pdf

7 US drug DTC cuts in 1st half 2008: TV ad effectiveness low, regulatory risk high? Pharma Marketletter. October 17, 2008.

8 California HealthCare Foundation. Social Media’s Challenge to Traditional Health Care Patients, Providers, Researchers, and Advocates Forge Online Connections. April 22, 2008. Accessed June 7, 2009 at: http://www.chcf.org/press/view.cfm?itemID=133633.

9 Thomaselli R. “Morning-After Pill” catches flak for MTV.com ad: site’s under-18 visitors will see banner for emergency contraceptive Plan B. Advertising Age. January 8, 2009.

10 US FDA swoops on YouTube “DTC Abuse.” Pharma Marketletter. December 4, 2008.

Image Credit:

1. tomsaint

Book Reviews: Global Politics & Pharmaceutical Industry Practices

Posted on by Corporations and Health Watch

Two books on the ethics, politics and practices of the global pharmaceutical trade. Reviewed are: The Global Politics of Pharmaceutical Monopoly, Power, Drug Patents, Access, Innovation and the application of the WTO Doha Declaration on TRIPS and Public Health by Ellen F.M. ‘t Hoen (AMB Diemen, 2009) and Global Pharmaceuticals: Ethics, Markets, Practices, edited by Adriana Petryna, Andrew Lakoff, & Arthur Kleinman (Duke University Press, 2006).

The Global Politics of Pharmaceutical Monopoly, Power, Drug Patents, Access, Innovation and the application of the WTO Doha Declaration on TRIPS and Public Health by Ellen F.M. ‘t Hoen (AMB Diemen, 2009. ISBN 97890-79700-06-6)

In her new book, The Global Politics of Pharmaceutical Monopoly, Power, Drug Patents, Access, Innovation and the application of the WTO Doha Declaration on TRIPS and Public Health, Ellen ‘t Hoen, former Director of Policy Advocacy for the Medecins Sans Frontieres (Doctors Without Borders) Access Campaign, outlines progress made in increasing access to medication and medical innovation. She also identifies critical unresolved issues in development and distribution of new medical technologies for the treatment and prevention of disease in the developing world. Specifically, this book describes how access to medication in the developing world is affected by the current global rules for pharmaceutical patents. The book highlights recent alternative mechanisms to encourage medical research and development in a way that also ensures access to the product—by separating the cost of research and development from the price of diagnostics, medicines, and vaccines.

Link to reviews of this book:

Knowledge Ecology Studies
European AIDS Treatment Group

Link to this book:

AMB Press (where you will find link to an on-line version of this book)

 

Global Pharmaceuticals: Ethics, Markets, Practices by Adriana Petryna, Andrew Lakoff, & Arthur Kleinman (eds.) (Duke University Press, 2006. 312pp. ISBN 082233741X)

This edited volume, a collection of ethnographies, tackles a timely topic- the inequalities produced by the current global pharmaceutical system that of the anthropologist. This collection provides insights into the burgeoning international pharmaceutical trade and the global inequalities reinforced by market-driven medicine. From an examination of how popular and professional understandings of psychiatric illness in the Western world to the experience of African families faced with the financial burden of AIDS treatment for its members, this book brings together experiences of individuals and communities and the roles they play along with organizations, corporations, and governments in the market-driven game of global pharma. This work is an important step in bringing the moral and ethical issues inherent in every phase of pharmaceutical production to the forefront of the social science research agenda.

Link to review of this book:

British Journal of Psychiatry

Link to this book:

Amazon.com

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