From the drug manufacturers to the patients, from advocacy groups to the government, each health category has a multitude of players.
Within every drug category exists a communications matrix that encompasses the work of pharmaceutical companies, the PR messages associated with individual brands, the education and lobbying efforts of advocacy groups, and government regulations. Oncology, pain, neurology, and mental health have several communications elements in common, but they also include unique qualities reflecting their own hot-button issues or trends.
Overall, pharmaceutical PR campaigns must adhere to Food and Drug Administration (FDA) regulations, which heavily impact messaging in all categories. Another commonality is that the pharma industry has become a crucial part of patient and physician education.
Nonprofit organizations also weigh in heavily in all disease categories by advocating at the state and federal government levels for more research funding and affordable healthcare. They also provide a large amount of education and support to patients, their families, and caregivers, as well as physicians.
New treatments needed
One of the issues impacting the communications matrix for this category, which includes such ailments as epilepsy, multiple sclerosis (MS), Alzheimer's disease, and Parkinson's disease, is the need for new treatments, says Kate Cronin, managing director of Ogilvy Public Relations Worldwide's global health and medical practice.
Advocacy groups are especially vocal on this issue. For example, the Alzheimer's Association has developed an initiative to speed safe drug development, notes Kate Meyer, manager of PR for the nonprofit group. "This illustrates one of the ways we work to lead the fight against the disease with leading scientists, individuals with early-stage Alzheimer's disease and their families, and experts on the FDA process," she says, adding that the association will also seek input from the pharmaceutical industry.
In addition to lobbying for new treatments, advocacy groups can also impact messages about and public perception of existing drugs, says Tony Russo, CEO of Noonan Russo and Euro RSCG Life PR in New York. For example, the MS Society helped shape public perception of the relapsing MS drug Tysabri (produced by Biogen Idec and Elan) after manufacturers voluntarily suspended product marketing in February 2005 after two deaths.
"We played an active role in the FDA advisory panel hearing on Tysabri, both as an advocacy organization and as a resource for accurate information," says Arney Rosenblat, MS Society public affairs director. The FDA is expected to make a final decision about whether to approve the drug for market by the end of June.
In the meantime, Biogen Idec and Elan have made safety evaluation and marketing suspension information available on their Web sites. Biogen Idec's site notes that patient advocacy "helped inform the process for reintroducing Tysabri in the US and also helped advance a better understanding that MS is a serious and often debilitating disease."
Stem cell research
Although groups such as the Michael J. Fox Foundation advocate for stem cell research to discover new treatments for neurological diseases, the PR world often views this as a topic that does not impact current messaging around brands. "We're looking at patients and what they want now to manage their disease and what products are going to give them a productive life," Cronin says.
The issue of stem cell research is broadly dealt with through issues management when promoting neurological pharmaceuticals, says Gregory Baird, partner and global healthcare industry leader at Porter Novelli.
Advanced Cell Technology, which conducts embryonic stem cell research, addresses controversy surrounding the issue by proactively providing the media and public with information about its research and "what it will take to go from the lab to the bedside," says the company's media spokeswoman Judy Katz, corporate communications EVP of the Investor Relations Group in New York.
"We don't do 'no comments,'" she adds. "Transparency for the pharmaceutical and biotech industry as a whole is key."
While drug pricing is an ongoing challenge in all medical categories, oncology biotech products have been in the news lately because of reports of high costs to patients.
The pricing issue is often oversimplified and requires a more open dialogue among pharmaceutical companies, the media, the general public, physicians, insurance payers, and government, says Laura Schoen, president of global healthcare at Weber Shandwick. "There's an incredible amount of misinformation, and people don't understand the cost of drug development," she says. "Years and years are invested, often for a small population of patients, and companies need to be able to make a reasonable profit."
To help remedy the situation, many pharmaceutical companies offer drug access programs to people in financial need. However, Medicare reimbursement can be a disincentive for pharmaceutical companies to give away drugs for free, notes Schoen. Giving away drugs at no cost lowers the overall reimbursement rate on the product.
Pharmaceutical companies are trying to respond to misinformation about their products in the media. For example, on March 29, Genentech, which manufactures the targeted therapy Avastin for colorectal cancer, issued a statement outlining its concern about inaccurate news coverage of the drug's expense. The company also used the opportunity to highlight its access program.
Nonprofits,, such as the American Cancer Society (ACS) and Lung Cancer Alliance (LCA), are also influencers that impact the drug cost issue and raise awareness about access to affordable healthcare with advocacy at the state and federal government levels. The ACS is monitoring the cost of cancer drugs and manufacturer access programs, while the LCA is working directly with the pharmaceutical industry. "We're working hard with companies to come up with programs to help patients gain access to drugs," says Laurie Fenton, LCA president.
Such groups also provide a large amount of public education about cancer screening, prevention, and treatments for which partnerships are important.
Education involves information gathering from public health institutions and pharmaceutical companies about product development, clinical trials, and drug marketing, says Fenton. "That's why being able to partner on public education campaigns and materials is important because it's all about sharing current information."
"More and more in the cancer community, pharmaceutical and biotech companies are partnering with multiple advocacy groups, forming coalitions to reach a broader number of patients," says Diane Weiser, COO at WeissComm Partners in San Francisco.
Advocacy groups know the cancer patient best, says Joy Schmitt, director of global product communications at Schering-Plough. The company is partnering with The Wellness Community and the National Brain Tumor Foundation to provide public education about the disease. "They know the patients' needs and have a different and greater reach than we do," she explains. Schering-Plough manufactures Temodar for newly diagnosed glioblastoma multiforme brain tumors.
The pain communications matrix has been greatly influenced by the withdrawal from the market of Merck's arthritis pain medication Vioxx in September 2004, followed by Bextra (Pfizer) in April 2005 owing to their cardiovascular risks.
"In the post-Vioxx world, the legal implications of promotion are profound," says Baird. "The FDA regulates promotion to one level, but the legal system regulates to an even more profound degree," he says, citing recent class-action cases brought against Merck.
Legal action often traces back to the promotional statements made by the pharmaceutical company, and this has become a driving force in how pharmaceutical companies and PR agencies craft messages.
To ensure transparency, Merck regularly posts updates on Vioxx litigation on its Web site, in addition to company statements about the drug, follow-ups on scientific data, and regulatory information. Shortly after Vioxx was withdrawn, Merck outlined its ethical research standards and actively dispelled media allegations that the company understated negative drug side effects. (Merck did not return calls for this story.)
Because of the Vioxx and Bextra withdrawals, more disclosure, less direct-to-consumer promotion, and more messages aimed toward the professional audience through education campaigns have become common, says Russo. He has worked on various projects within the pain category, specifically Boehringer Ingelheim's drug Mobic. Euro RSCG Life's sister ad agency, Euro RSCG Life LM&P, worked on Bextra before it was pulled from the market.
Another controversy is opioids, used for moderate-to-acute pain relief, often for the lower back or in cancer patients, which have received media attention owing to addiction risk. Addiction to some pain relievers, such as the narcotic OxyContin, has been highly publicized, and some people think the drug may be overprescribed.
Consequently, PR professionals are careful when promoting these drugs to disclose the side-effect profile and understand that patients and professionals need to be acutely aware of risks, says Russo. Pharmaceutical companies have strengthened the warnings and precautions sections in drug labeling.
The American Chronic Pain Association weighs in on the arthritis pain medication and opioid issues by "encouraging individuals to have a conversation with their healthcare provider based on their own medical history," says Penney Cowan, founder and executive director of the organization, adding that patients need to know the benefits and risks of any medication.
A challenge in this category is antidepressants and their risk of causing suicidal thinking and behavior in teenagers and young adults, which has affected physician prescribing habits and consumer acceptance of these drugs, says Megan Svensen, EVP of healthcare at Marina Maher Communications. Svensen's antidepressant experience includes work on Zoloft (Pfizer) and Wellbutrin (GlaxoSmithKline).
Pharmaceutical companies have addressed this issue by re-examining the data to determine risk, says Svensen. "They've tried to be very responsive in terms of making sure promotions for products are for their specific indications and not overpromising on their benefits." The FDA also asks manufacturers to include a boxed warning on their drug labels.
In May, GlaxoSmithKline made clinical trial data on Paxil's suicide risk in young adults, aged 18 to 30, available to physicians via a letter, as well as on its Web site.
"GlaxoSmithKline's policy is to ensure transparency of the clinical data the company collects on its marketed medicines," the company said in a statement.
Advocacy groups are much better positioned to take up the mantel of mental health issues than pharmaceutical companies are because people don't usually perceive the former as self-serving, notes Svensen.
For example, the American Psychiatric Association (APA), National Alliance for the Mentally Ill, and the National Mental Health Association issued a joint statement about Tom Cruise's Today show interview, in which he criticized the use of antidepressants. The groups explained the benefits of treatments and described Cruise as "irresponsible" for using a movie publicity tour to promote his own ideological views.
Another controversy is care for children with attention deficit and hyperactivity disorder (ADHD), which has drawn criticism for being overprescribed for, as well as for abuse of the drugs that treat it.
PR agencies have sought to educate parents and school nurses about ADHD symptoms, emphasizing that physicians need to diagnosis and oversee drug therapy, says Cronin. In addition, pharmaceutical companies have worked to educate the public about the signs of abuse and include drug dependence information in labeling.
"Parents and physicians need and deserve as much information as possible about the risks and benefits of all interventions in order to make fully informed decisions about treatment options," says David Fassler, MD, APA trustee at large, and clinical professor of psychiatry at the University of Vermont. Consequently, the APA and other groups have developed informational materials about the diagnosis and treatment of child psychiatric disorders.
Whether a patient has ADHD, depression, or another mental illness such as bipolar disorder or schizophrenia, family and caregivers are especially important to the communications matrix because they are the first to notice signs and symptoms of mental disorders, and they also take notice when patients have stopped taking their medication, says Cronin.