Emma Johnson

“To find out if XYZ is right for you, ask your doctor.” Drug companies’  advertisements promoting their wares directly to consumers have soared since the  Food and Drug Administration began allowing the practice in 1997. 

In fact, between 2000 and 2006, pharmaceutical company spending on  direct-to-consumer, or DTC, advertising to potential patients doubled to about  $5 billion—a figure that corresponds with critics’ reports that DTC advertising  has changed the traditional doctor-patient dynamic, and has led to congressional  hearings challenging laws governing such ads.

Like ads for other consumer products, DTC drug advertisements on television,  radio, the Internet, and in magazines also promote their products—prescription  remedies&mdash;directly to potential consumers. However, this is a radical departure  from the way consumers have traditionally learned about medicine, in which  patients relied on physicians’ medical expertise to learn about appropriate  drugs or therapies.

The message coming from advocacy groups and drug companies alike is that an  informed consumer is a healthy, empowered patient. The push for an informed  consumer is part of a larger trend in which more people are getting health  information from various forms of media as the number of available therapies  surge, and an increasingly educated population demands access to the latest  cures. The question is, do DTC ads inform and empower consumers, or do they  hinder the health care system and endanger patients?

A growing number of critics charge DTC drug advertising is costing the health  care system by way of increased drug prices, patient confusion, compromised  care, and an eroded patient-physician relationship. The drug and medical device  makers deny the practice increases health care costs, and say it in fact helps  patients remember to take their medication regularly, as well as informs the  public about the importance of screening for cancer and other diseases.

“Any claim about direct-to-consumer advertisements being primarily  educational is just false,” says Peter Lurie, MD, deputy director of the health  research group at the Washington, D.C.-based consumer rights organization,  Public Citizen, pointing to research that shows doctors are more likely to  prescribe drugs to those who ask for them. “Instead (DTC ads) are about  carefully selected drugs that the patient is likely to convince the doctor to  prescribe. Drug companies are in the business of selling drugs.”

The issue becomes more complicated when the patient learns of the  increasingly close relationship many doctors have with drug companies, which  often offer financial perks—practices that may influence the way doctors  prescribe drugs and procedures, says Reshma Jagsi, MD, PhD, radiation oncologist  at the University of Michigan Health System who recently authored an article on  doctor-industry conflicts of interest in the 

. In fact, an article published in April in the 

 found that 94 percent of physicians had some sort of  relationship with the pharmaceutical industry.

“Industry and physicians are developing more complex relationships,” Dr.  Jagsi says. “So increased transparency is essential if we want to continue to  have trust between the doctor and patient. This takes on a heightened importance  in the context of drug advertising, as patients need to be able to rely upon  their physicians to serve as unbiased intermediaries” between the drug companies  and patients, she says.

A bill approved by the Senate in May would allow the FDA to fine drugmakers  for false or misleading ads, but the legislation did not include a  recommendation from the American Medical Association and the Institute of  Medicine to impose a two-year wait period in addition to the current policy of  reviewing each ad for balance in presenting the benefits and risks associated  with each therapy. Dr. Lurie says such a wait period would make the practice  safer, as it allows more time to ensure a drug is safe before DTC advertising  leads to mass consumption.

A study published in April in JCO reports problems persist in DTC ads for  cancer drugs. Researchers studied cancer-related DTC ads in 13 consumer  magazines, including 

, and found overall that the text was  complicated and difficult for most people to understand.

So what is the consumer to do? Drs. Jagsi and Lurie agree patients must be  even more empowered to take charge of their health care. Ask pointed questions  to physicians, such as, “Where do you get your information on this drug?” and  “Is there an effective generic version of this drug?”

“The answer is still, ‘Talk to your doctor,’ ” Dr. Lurie says. “But push them  harder to justify their decisions.”

Articles

 Drug companies’ advertisements promoting their wares directly to consumers have soared since 1997.

Direct-To-Consumer-Advertising: Education or Confusion?

When the Women’s Health Initiative reported in July 2002 the link between  hormone replacement therapy, or HRT, and increased risk of breast cancer, the  medical community and millions of women had their worlds rocked. 

These findings were substantially underscored in December 2006 at the annual  San Antonio Breast Cancer Symposium. There, researchers from M.D. Anderson  Cancer Center in Houston presented an analysis that found 14,000 fewer U.S.  women were diagnosed with breast cancer in 2003 than in 2002, and that the drop  was attributable to reduced HRT use.

The decrease from 203,500 breast cancer cases in 2002 represents a 6.9  percent overall drop, and a whopping 12 percent drop among women ages 50 to 69  with estrogen receptor-positive breast cancer—the variety fueled by estrogen.  Diagnosis rates had been steady for the preceding few years.

However, like any ground-breaking news, the population study was met with  debate. Some breast cancer research leaders question whether the information is  conclusive, and warn against dismissing positive trends in cancer  prevention.

Since the late 1970s, tens of millions of women had been taking this common  treatment—many for a decade or more. Commonly used by postmenopausal women, HRT  was proven to reduce discomfort associated with menopause and health risks like  osteoporosis caused by the natural drop in the hormones estrogen and  progesterone.

By summer 2002, 30 percent of postmenopausal women were on some form of HRT.  But one year after the WHI report made headlines, there was a 66 percent drop in  prescriptions written for Prempro™, and a 33 percent drop for Premarin®—two  popular HRTs.

Peter Ravdin, MD, PhD, research professor of biostatistics at M.D. Anderson  and lead investigator of the population study, says such numbers suggest a  connection between reduced HRT use and lower risk of breast cancer. “We observed  a marked change in breast cancer rates in 2003 after numbers had been stable for  the past few years,” Dr. Ravdin says. “The most obvious change was in use of HRT  starting in July 2002.”

The significant decrease, as well as the number of patients affected, meant  big news in San Antonio. While he agrees “hormone replacement is a very good  hypothesis,” and the report offers “useful information,” Victor Vogel, MD,  professor of medicine and epidemiology at University of Pittsburgh-Magee Women’s  Hospital, worries the study is not conclusive since it does not randomly study  the cause of the reduced breast cancer cases. Further, Dr. Vogel says the  sensation the M.D. Anderson report caused could lead those who were watching  their diets and getting regular mammograms to now disregard those practices. “I  think we should always hold out to think we’re not as smart as we think we are,”  he says.

He points to an alternative, or contributing, explanation to the drop—the  high rate of mammograms throughout the early 2000s that caught early cancers,  which were removed before developing into full-blown invasive cancers. Positive  diet changes might be another factor, Dr. Vogel says. Others have suggested the  lowered rates could be linked to increased use of the selective estrogen  receptor modulator Evista® (raloxifene), prescribed for osteoporosis but  recently proven to lower the risk of invasive breast cancer in high-risk women.  The FDA is currently reviewing Evista for approval in this setting.

Dr. Ravdin believes news of the connection between HRT and breast cancer only  heightens the message that individuals have the power of choice in their diet,  exercise habits and whether to use HRT. “We have not absolutely proven why the  drop in incidence occurred, but one thing that was good about our presentation  is that it will cause a lot of other people to look into their data to see the  effects of reducing HRT use.”

The WHI is scheduled to report more findings based on a randomized study by  year’s end, says Dr. Ravdin. In addition, studies are currently under way in  Canada and Europe that examine the effects of halting HRT use. “On one level,  HRT research isn’t glamorous,” Dr. Ravdin says. “It’s not like curing cancer.  But it is very important because it touches almost everybody directly or  indirectly."

The medical community strikes up a debate after a 2006 study released data linking the decreased use of hormone replacement therapy to the recent decrease in breast cancer cases. 

Report Incites Controversy After Breast Cancer Decline Linked to HRT Use

There has never been more information about the cause, prevention and treatment  of cancer. Record numbers of reports in the academic and lay press abound, and  access to this information is greater than ever before. Yet the age-old practice  of sharing and holding onto myths about cancer persists today—perhaps more than  ever.

Healthcare workers routinely hear from patients: A positive attitude cures  cancer. Pain associated with cancer treatment is so severe, it is better to  forego it, as pain medication is barely effective and highly addictive. Surgery  only spreads cancer.

Belief in such myths is far from anomalous. A survey commissioned by the  American Cancer Society found that a whopping 41 percent of people believe  treating cancer with surgery can spread the disease through the patient’s body,  and 27 percent believe that the medical community is withholding a cure for  cancer to boost profits.

While this and other recent studies found that some myths are intensified in  minority groups, cancer myths permeate all populations. A 2006 Harris  Interactive survey underwritten by pharmaceutical company Eli Lilly found that  only 37 percent of women age 55 and older were concerned about developing breast  cancer as they aged, although age is one of the top risk factors for developing  breast cancer. Further, few people recognize the cancer risks associated with  obesity, while the notions that underarm antiperspirant and underwire bras  contribute to the development of breast cancer are among the top myths often  associated with the disease, says Ted Gansler, MD, director of medical content  for the American Cancer Society. “There are all these important things people  need to know to prevent cancer and find it as early as possible. Meanwhile,  focusing on things that are not significant might distract them,” Dr. Gansler  says.

The risk of these beliefs is much graver than believers embarrassing  themselves at a cocktail party. Myths can be one barrier to getting effective  screening and making appropriate treatment decisions—both of which can result in  decreased survival and increased chances of complications and mortality. “The  big problem with myths is they lead people to not getting appropriate and timely  therapy,” says Timothy Moynihan, MD, an oncologist at Mayo Clinic in Rochester.  Distrust of the medical community can stand in the way of regular checkups,  mammograms and colonoscopies, for example, while fear of surgery spreading  cancer can prevent someone from having a surgical biopsy or invasive tumor  removal, Dr. Moynihan says. Belief that pain medication is ineffective or  addictive, as reported in the ACS study, is another myth that can cause needless  suffering.

The conundrum is intensified when further breakdown of such stats point out  that myths are often aligned tightly with certain minority groups and the  poor—groups that often do not get the medical attention they need, says Dr.  Moynihan. “The fact is that certain groups are seriously underserved by the  medical community. They are uninsured and less often screened and treated for  things like high blood pressure and diabetes,” he says. Access to care issues  can include transportation and childcare, availability of healthy food and safe  exercise. “Effective cancer screening is just one part of that very complex  problem,” Dr. Moynihan says.

Case in point: Anita Patterson was 30 when she noticed a lump in her left  breast. When a doctor dismissed her concerns because of her young age, she did  too. “I always thought only older people got cancer,” says the resident of  Wapato, Washington, and member of the Yakama Native American tribe. Five years  later, she was diagnosed with breast cancer after doctors removed an egg-sized  lump. Because of the aggressive nature of her tumor, doctors recommended  mastectomy because of the increased risk of recurrence. Despite their urging,  Patterson chose lumpectomy with radiation, as she had heard from others in her  community about the pain associated with mastectomy.

“I thought, ‘I have to go back to work—I don’t want to go through that,’ ”  says the married mother of three boys. Her concerns were complicated by what she  says is a stigma in her community associated with losing a breast, as well as  having a disease associated with white people. When the cancer returned five  years later, she had a mastectomy. Patterson, now 45, says that if she had known  the risks and understood the facts 15 years ago, she could have been saved years  of emotional and physical pain.

Experts say there are real reasons some people hold onto myths about cancer  and how it is detected and most effectively cured. On a fundamental human level,  myths are perpetuated simply because people seek information from trusted  sources, says Angelina Esparza, the American Cancer Society’s director of  survivorship, quality of life and information. People will usually follow the  screening and treatment directives of a healthcare provider, but in the absence  of a long-term, trusting relationship with a physician and healthcare system,  accurate information competes with messages from mass media and trusted friends  and family. “Patients rely on their various sources for information about their  healthcare—providers, television and family and friends,” Esparza says. “But  with all of the competing messages, how is a patient to figure all of this out  and know where to turn for information?”

Esparza, who has spent a dozen years working in minority health advocacy,  says it is important to develop cancer education tools that take the culture of  various communities into account. She cites the success of videos for Hispanic  populations that use culturally appropriate scenarios to introduce information,  as well as an emphasis on audio CDs and tapes to reach illiterate members of all  groups. Since many patients obtain information from the Internet, it’s important  to double-check it with reliable sources, including your physician and  organizations like the National Cancer Institute.

The key is not to simply get the medical information to the population in an  effort to dispel all myths, says Esparza. Instead, many widely held beliefs can  be used to promote sound medical advice. “You’re not going to change people  overnight,” she says. “What you can do is integrate information.” If a person  relies on their community to make decisions, the medical team can use that  support system to ensure adherence to a medical directive. If a person relies on  prayer for medical healing, encourage that practice in addition to clinical  treatment. “Start correcting what is wrong and fold it in together with what  they are doing right,” Esparza says. “If we can blend these things and blend  them well, we are providing the patient the best service.”

Experts agree that the most critical key to dispelling myths is a trusting  doctor-patient relationship. “Once the vast majority of cancer patients are  under the care of a qualified cancer specialist who takes time to explain the  disease, their beliefs in myths will not persist,” says Dr. Gansler. Adds Dr.  Moynihan: “We have to treat each person well, so that person will bring that  trusted word back to their community. That’s the long-term fix. In the  short-term, we have to establish trust.”

As for Patterson, she turned a negative situation into a positive. Women in  her community often approach her with questions about their own cancer,  including her younger sister Andrea Williams, who found a lump in her own breast  at age 30—an age she would have thought was too young to be vulnerable to cancer  if it were not for her sister. Patterson urged Williams to get a mammogram and  early treatment once breast cancer was confirmed. “My experience was different  than my sister’s,” says Williams, who is now in remission. “If it weren’t for my  sister educating me, I wouldn’t have known what to do.”

In an age of information abundance, myths about cancer  abound.

Cancer Myths

Such product advertising through the use of a nonprofit’s name is known as  “cause-related marketing”—and these arrangements are on the rise. This year,  U.S. companies will spend $1.34 billion on cause-related marketing, up from  $1.17 billion last year, according to IEG, a Chicago-based marketing firm  specializing in sponsorship. One of the earliest examples is American Express’s  1983 support of the Statute of Liberty restoration. 

In a perfectly executed cause-marketing arrangement, everyone wins. The  organization benefits by way of a budget boost and expanded exposure, while the  company profits by being associated with a trusted organization and a good  cause—endearing themselves to current and potential customers, which results in  an increase of sales.

In many cases, the consumer of cause-related marketing also wins—as does the  public at large. Individuals can easily put money where their heart is, and the  infusion of funds helps the organization increase public education and advance  medical research or policy advocacy, says Jeff Manning, manager of corporate  relationships for the Lance Armstrong Foundation. “Not everyone is great about  returning direct mail, and nonprofits are always looking for creative ways to  help people looking to support their mission,” he says. “Cause marketing is a  great way to do that.”

But when donation-dependent charities and for-profits meet, there is an  inherent danger of the giver’s interests influencing that of the receiver, warns  Michael Jacobson, executive director of the Center for Science in the Public  Interest, a Washington, D.C. consumer advocacy organization. “Industry funding  is very tempting because it often comes in big bundles,” Jacobson says. “In some  cases there is no problem at all, like if a mattress company gave $1 million to  the American Cancer Society. But more typical is when a company closely related  to the organization’s activity starts dangling gifts. Then the funding can  influence an organization’s behavior in a number of ways.” The charity might  feel obliged to promote the donor’s product, refrain from criticizing the  donor’s product or activities, or compromise their mission to the betterment of  the donor.

A blatant example of such behavior-altering funding: In 2003 the Coca-Cola  Foundation gave $1 million to the American Academy of Pediatric Dentistry. The  organization’s president at the time then denied any scientific evidence linking  soft drinks to childhood oral disease—contradicting its earlier position on the  subject.

But not all pitfalls of cause-related marketing are so obvious, Jacobson  says. In the case of health nonprofits, consumers should be wary of the  abundance of pharmaceutical donations, which can influence an organization to  emphasize disease treatment over other issues, such as prevention or  survivorship. “It’s impossible to quantify, but most independent observers would  agree there is going to be an impact,” Jacobson says.

Cancer nonprofits interviewed for this story all say there are certain  companies they refuse to partner with—mainly tobacco and alcohol makers.  Marykate Wilson, cause marketing director for the American Cancer Society, says  the organization’s “self-imposed rules of engagement” dictate that all of the  organization’s 20 cause-related marketing partners meet strict criteria,  including proper scientific review for medical products, clear messaging and  proper government documentation.

The LAF’s Manning says the organization seeks out companies with a deep  interest in its mission. This ensures a longer relationship, and sometimes an  added marketing tool. Recently the foundation partnered with Chantal cookware,  whose owner is a cancer survivor, to produce the LIVESTRONG by Chantal  Collection.

Consumers should keep a few things in mind when putting their money with a  cause-related marketing promotion, including the terms of the promotion—how much  money from each sale goes to the nonprofit and what the money is used for&mdash;if  there’s an educational component to the campaign and if the campaign resonates  with individual beliefs and priorities. 

Yoplait yogurt gives to the Susan G. Komen Breast Cancer Foundation, and you stock up the grocery cart with your favorite flavor. Nike supports the Lance Armstrong Foundation--and so you choose those sneakers over others.

A Worry-Free Way to Support Nonprofits?

It was a landmark medical breakthrough when, 23 years ago, human papillomavirus, or HPV, was found to cause almost all cervical cancers. 

The fight against the disease just won another battle, as Gardasil®, the first vaccine proven to prevent the most dangerous strains of HPV, was approved in June by the Food and Drug Administration—promising to drastically reduce cervical cancer death rates worldwide. Some say the sexually transmitted HPV could be eradicated completely.

Doing so could save millions of lives. Each year about 10,000 U.S. women are diagnosed with cervical cancer, and about 40 percent will die from it. Cervical cancer also affects 500,000 women worldwide each year—killing more than half. Though millions carry the virus in the United States alone, the vast majority never get cancer.

Douglas Lowy, MD, the National Institutes of Health researcher who helped develop the vaccine, called Gardasil a monumental achievement. “Women will have fewer serious HPV infections that may lead to abnormal Pap smears requiring treatment,” Dr. Lowy says. “The likelihood of cervical cancer will be lower, and they’ll have fewer genital warts.”

Studies involving more than 20,000 women showed that Gardasil is 100 percent effective in preventing HPV types 16 and 18, which cause 70 percent of cervical cancer cases, and types 6 and 11, which cause 90 percent of genital warts, when administered before a woman becomes sexually active. The vaccine, approved for women ages 9 to 26, is given in a series of three injections over a six-month period, each priced at $120. It has shown no serious side effects.

Enthusiasm for the future of a cervical cancer cure is boosted by a second vaccine, Cervarix™, in development by GlaxoSmithKline, which expects to file the vaccine for approval later this year. While Merck’s Gardasil has proven effective in guarding against HPV strains associated with both cervical cancer and genital warts, Cervarix has thus far only been proven to stave off the cancer-causing types 16 and 18. “There is presumably room for two manufacturers,” says Dr. Lowy, who is involved in studies of both vaccines. “There will be a lot of demand on a worldwide basis because cervical cancer is the second most common cancer among women worldwide” after breast cancer, he says.

The impact of this discovery is heightened by Merck’s continued research into whether Gardasil protects against other strains of the virus (HPV is a group of more than 100 viruses), potentially increasing the understanding of the vaccine’s power to prevent cervical cancer.

But the task of reducing HPV is faced with social and economic hurdles in addition to the scientific. Convincing parents to vaccinate their children may be one obstacle. A recent survey of 200 women ages 23 to 53 found that 77 percent would be willing to accept an HPV vaccine for themselves, while 67 percent of those who had a daughter and 66 percent who had a son were willing to have their child vaccinated. (The reason to vaccinate boys is because they can serve as asymptomatic carriers and pass the virus to female sexual partners.)

There was initial concern that conservative groups would oppose HPV vaccination, but the Family Research Council, a leading Christian lobby group, came out in support of the product.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended in late June that HPV vaccination be made available to all FDA-approved age groups, which means health insurance plans will now be likely to cover the $360 price tag and availability should be widespread by August. The committee also wants the vaccine included in the federal Vaccines for Children Program, which provides free immunization to uninsured and underinsured children. Merck has rolled out an aggressive disease education program connecting HPV with cervical cancer, and the company is also pitching the vaccine to pediatricians, primary care doctors and gynecologists through a shared sales team of 1,000 representatives.

However, public health experts worry that administering the product in the developing world, where the majority of HPV cases exist, is problematic. In an effort to bridge the economic gap, the Bill and Melinda Gates Foundation recently donated $27.8 million to the Seattle-based Program for Appropriate Technology in Health to work with drug makers and public health organizations to facilitate HPV vaccination in developing countries.

Bradley Monk, MD, a gynecologist and associate professor at the University of California Irvine Medical Center, where he conducts research on HPV and cervical cancer, says that despite obstacles, he hopes Gardasil will be the beginning of the end of cervical cancer worldwide. “It’s like smallpox—we vaccinated the world. It killed hundreds of thousands of people and now it’s completely gone.” 

This article discusses the FDA approval of Gardasil, the first cervical cancer vaccine.

Emma Johnson

Direct-To-Consumer-Advertising: Education or Confusion?

Report Incites Controversy After Breast Cancer Decline Linked to HRT Use

Cancer Myths

A Worry-Free Way to Support Nonprofits?

First Approved HPV Vaccine Could Slash Number of Cervical Cancers

Latest News