Energy. An active lifestyle. Mental and emotional stability. Absence of disease. Nutrition. These are some of the words and phrases that the public used to define “health” in the 2011 Edelman Health Barometer, released in October.

“What does it mean to be healthy?” Edelman posed this open-ended question to 15,000 respondents in 12 countries and captured, verbatim, the public response. “The public is redefining ‘healthy’ as ‘How I act, what action I can take, and what actions I do take,’ rather than just ‘how I am,’” explains Nancy Mensch Turett, global chair, Health, at Edelman. And increasingly, the barometer found, this less frequently means people’s perceptions of the environment and their dealings with the healthcare system, and more often their own lifestyle and nutrition choices. “And when we asked people who influences their health—their lifestyle and nutrition—the most, second only to themselves were family and friends.”

The implications of such a statement are far-reaching. It means that regardless what standards of health or beauty we see in Hollywood, which hot new fitness personality bombards us with ads, or even how many times our doctor tells us we should really drop a few pounds, what’s really going to influence our behavior and help spread the habits that make good health communicable is each other.

“We believe there is no such thing as a non-communicable disease,” says Turett. “All diseases are communicable, whether through viruses, bacteria, behavior, or a combination of these things. A key to the future well-being of the healthcare industry, but even more importantly to society, is to understand the communicable nature of all health.” For example, the barometer found that 31 percent of respondents will spend less time with a friend because of the friend’s unhealthy behavior. Additionally, according to study results, the idea of influencing one’s peers and driving communicable good health is a bigger motivator for maintaining one’s own healthy habits than personal gain—41 percent of respondents listed “realizing that the long-term health benefit of another person would improve” as their primary trigger of action in personal health advocacy. Another 28 percent listed their primary trigger as “making a personal commitment to help others.”

Turett compares being healthy to being “green” in that, like environmental consciousness, “the sustainability of our species depends on it.” Health is “the most personal of public issues and the most public of personal issues,” she says, and so “people are very attuned to brands’ and companies’ engagement in health. And from the standpoint of the pharmaceutical industry and the healthcare industry more broadly, this means that because your business is actually a social issue—one that people feel so personally and strongly about, and is such a big public issue from an economic and societal viewpoint—people in the business of health need to attend to the social as well as the business impact of their actions.”

Much like the “green” movement, the public in fact expects government, corporations, and healthcare stakeholders to be a positive influence. And despite the bad rep we sometimes believe pharma has earned for focusing only on the bottom line, the truth is, pharma is in fact a trusted authority whose input the public values—and expects—when it comes to health issues. “In our first study we saw that the public craves engagement from the brands and companies that are involved in health,” she confirms. “The public feels that being active in health is actually an imperative for businesses across the board. People are basically saying, if you want to be relevant to me and really make a difference in my health, you need to support lifestyle and nutrition. You can’t just come to me through other channels like the healthcare system.”

This year’s health barometer confirmed those findings, showing that all businesses are expected to engage with their employees and the public as a whole on health issues, through avenues such as education communications, public policy, philanthropy, partnerships, and innovation centered on spreading and encouraging healthy behaviors.

When you consider the heavy influence of peers on health today, the digital world can no longer be overlooked. Online health communities of peers—groups of patients with the same diseases and health conditions commiserating and collaborating together—are undoubtedly part of the peer influence in today’s “health 2.0” environment. And those in this multimedia space also agree that pharma has a rightful place at the table when it comes to making good health communicable. “Patients in these online communities are not cynical of pharma for the most part. I think this almost conventional wisdom that patients are skeptical or cynical of pharma companies—I don’t see that,” says Brian Loew, CEO of Inspire, which partners with nonprofit organizations to create and host online support communities for patients and caregivers in specific therapeutic areas. “You don’t see patients looking for bad guys and conspiracy theorists. You see patients who are saying, ‘I’m really grateful that I have these treatments. I’m trying to fine-tune it, I’m trying to find out what the best treatment is,’ but they’re incredibly appreciative of the therapeutic drugs that they are taking. And they overwhelmingly don’t have animosity towards the companies. I’d love it if we could debunk some of that, because I think people feel good about pharma companies.”

Catie Coman, director of communications at the National Psoriasis Foundation (NPF)—which has partnered with Inspire for a patient online community called TalkPsoriasis—agrees. “Patients look to the pharma companies and their websites for authoritative information. So, if I want to learn everything possible about what’s on the label for a psoriasis treatment, for example, I go to the manufacturer’s website. I think they look to pharma information as valuable reference material, at least based on what we see.”

Indeed, in a new study—ePharma Consumer 2011—released by pharmaceutical and healthcare market research company Manhattan Research, 42 percent of online consumers agree that pharmaceutical companies should be involved in online health communities for consumers. The study, of 6,643 U.S. residents ages 18 and over, also found that 39 percent of online U.S. adults visit pharma prescription drug websites, and 35 percent visit pharma corporate websites. Clearly, the messages pharma chooses to send matter, and in fact consumers are looking for more, not less, input from pharma. “We asked online consumers about their use of and interest in various types of online information and tools from pharma companies. The results revealed that there is considerable unmet demand for disease management support (online tools or information to help manage a condition) and consult preparation (guide or tools to help prepare for a discussion with a doctor),” Manhattan Research told Pharm Exec.

“Pharmaceutical marketers and communicators who are looking to really create communities of health, and to support not only the healing but also the prevention of unnecessary progression of disease, really should be looking at the social unit and not just the individual,” says Turett.

FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies.

The kicker: The drug was approved 14 years ago.

FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen generics firms—the green light in 1996 as part of the fast-track approval program designed to speed to market drugs for diseases with no current treatments.

The catch is that FDA requires post-market clinical trials to ensure that the drug is meeting risk/benefit endpoints. In other words, the regulatory body wanted to make sure no hiccups occurred with the treatment when it hit the general population.

In response, Shire—who acquired the drug when it bought Roberts Pharma in 1999—chose to withdraw the drug as of September 30. The drug firm made it clear that the withdrawal had nothing to do with any safety concerns. In addition, Shire stated that it had conducted post-market trials in conjunction with Roberts, but FDA felt the results were “inconclusive.”

According to a release by FDA, none of the companies selling the drug have provided any data to prove that the treatment is beneficial. That said, some 100,000 people were treated with the midodrine hydrochloride last year alone.

“We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients,” stated Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing a withdrawal of the product.”

FDA stated that patients currently on midodrine hydrochloride should not stop taking the medication. Shire now has 15 days to respond to FDA’s inquiry and provide some data supporting the drug. Shire did not respond to calls as of Monday afternoon. In addition, it’s unclear as to why FDA waited so long to ask for more data and whether any adverse reactions have been reported pertaining to the drug.

A research team in Belgium discovered a new test that has proven successful at identifying patients that are developing Alzheimer’s disease, according to a report published in the Archives of Neurology on Tuesday.

The study took spinal fluid from patients with varying levels of cognitive memory and looked for a specific protein signature or biomarker that has been attributed to Alzheimer’s.

Researchers tested more than 300 seniors—some with the disease, some suffering with recall difficulty, and some with no sign of Alzheimer’s. The study proved that 90 percent of the patients already diagnosed with the disease had the particular protein characteristic. Seventy-two percent of patients with some memory problems tested positive for the protein, and only 32 percent of patients in the normal cognition group had the biomarker.

Even more fascinating were the results of a second test of deceased patients confirmed to have Alzheimer’s. In that study, 64 out of 68 patients tested positive for the protein.

Healthcare professionals hope that the test can be used to detect Alzheimer’s way before the disease takes hold. Presently, the only way physicians can prove that a patient has the disease is post-mortem, making it very hard to isolate and treat it. Instead, doctors diagnose the disease through process of elimination—not the most reassuring method.

The downside to the test is that the spinal tap used to capture the fluid is notoriously painful, so it’s doubtful that healthy adults would elect to undergo the procedure—especially if insurance doesn’t cover it. There is also a fear of depression due to early detection or a false positive. The fact is, there are no medicines on the market to stop or slow the disease, so treatment—at this time—is fairly futile.

For the pharma industry, the new test could help researchers isolate trial participants by those most likely to have the disease, rather than test a broad range of people with cognitive problems, many of which might not have Alzheimer’s.

“We have to go very early to patients who have just the beginnings of Alzheimer’s in their brains—those are the people we need to identify to test the treatments,” Stephen Ferris at New York University’s Alzheimer’s Disease Center told CBS News. “That’s why these spinal fluid tests are going to be extremely important over the next few years.”

Personalized medicine has been one of healthcare’s most anticipated and least understood treatment paradigms. Physicians remain optimistic regarding its future, however the 52 doctors surveyed differed in their views in its implications for therapeutic research and development (R&D). Patients, by contrast, were viewed as increasingly interested in embracing the therapy.

Physicians were asked in which therapeutic areas do they feel the use of personalized medicine—for example, the use of genetic testing to tailor drug therapy to an individual—would be most prevalent. Of the doctors surveyed, nearly 58 percent said oncology/hematology, followed closely by cardiology (48 percent), allergy and immunology (38.5 percent), endocrinology (32 percent), and rheumatology (nearly 29 percent). In contrast, doctors felt the therapy would be least common in orthopedic surgery and obstetrics/gynecology.

Clinicians disagreed, however, on whether financial incentives are strong enough to encourage widespread collaboration between developers, payers, consumers, and pharma. When asked, “How will the adoption of personalized medicine affect the priorities and processes for pharma/biotech R&D?” physicians’ anonymous responses ranged from, “More opportunity for profit will drive new genetic testing,” to “No effect.” (It should be noted that a greater percentage of doctors did feel that opportunities for profit and for developing new drugs would increase.)

The Cost of Adoption
Much like a new consumer technology or ‘green’ product, the limits to widespread adoption are directly affected by the costs to the patient or payer. This is backed up by the Lehrman/Bloomberg survey, in which nearly 81 percent of respondents felt the adoption rate was directly affected by the willingness of the patient or payer to pay. And even when personalized medicine is adopted, 79 percent of physicians feel it would be only narrowly embraced.

These numbers are based on several factors, not least of which is the collaboration between diagnostics companies, drug makers (including pharma companies and biotech firms), patients, and physicians, the combination of which is where survey respondents think the big push will come from. Several clinicians believed that therapeutic companies would continue to target known genetic situations where biomarkers are linked to disease. Others believed that the entire R&D paradigm would change to link effective therapy to individual patient genetic profiles. The biggest detriment to adoption seemed to fall on whether the right incentives are in place to foster collaboration between the therapeutic and diagnostic companies toward developing personalized medicine therapies—are the financial incentives strong enough to encourage the collaboration needed?

Overall, what is garnered from the Lehrman/Bloomberg survey on The Future of Personalized Medicine is that diagnostic and therapeutic companies will have to partner to champion wider adoption rates. It is this participation that will help to alleviate payer and patient concerns over paying for additional screenings as well as higher targeted therapy costs.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 10–6 against recommending approval for the drug, a combination of phentermine and topiramate. Phentermine is the ‘phen’ in infamous weight-loss drug Fen-phen, which was pulled form the market in the late ’90s due to its damaging effects on the heart. Likewise, topiramate was studied several years ago and was also found to be beneficial, but not without serious side effects.

The panel concluded that the drug is effective, and data shows that people can lose anywhere from 6 percent to 10 percent of body weight, if taken in conjunction with a diet and exercise regimen. However, the committee was concerned about increased risk of psychiatric and cognitive issues uncovered in Vivus’ trials, and said that there was a lack of data to rule out cardiovascular risks and the drug’s potential to cause birth defects in women who become pregnant while taking it.

There were also concerns because 18 percent of participants taking a high dose withdrew from trials after experiencing mild side effects, such as tingling of the hands and feet, headache, and constipation. About 40 percent of all participants either taking high or low doses of Qnexa did not complete the study for various reasons.

The FDA usually follows the recommendation of its advisory panel, but the split vote, and some of the comments by panelists, may leave the FDA room to approve the drug.

The popularity of unbranded pharma Web sites amongst consumers appears to be on an up tick, according to new data released by Manhattan Research this week.

The report, “Unbranded Web sites: Brand Reach throughout the Patient Life Cycle” looked at how many consumers actively use unbranded pharma sites and to what degree they trust the information. Thirty-five percent of consumers interviewed said that they do use these sites though many might not have been aware that pharma companies ran them.

“We found that relatively few consumers outright mistrust pharma online resources,” said Monique Levy, senior director of research, Manhattan Research. “On the flip side, there a lot of consumers that are cautious yet open to using pharma resources.”

When asked what kind of content they would like to see on the site, information about the condition wasn’t the primary service or utility that they were looking for. The top tools consumers want are financial assistance and incentives, tools for finding specialists, and tools that allow them to manage their condition day to day.

“People are not looking for the type of information that they can find on a WebMD, disease association, or a government site,” Levy said. “They seem to be interested in looking for supportive services.”

Levy said that marketers commonly state that it’s hard to measure the impact of unbranded initiatives. The goal of informational campaigns is to raise awareness and motivate consumers to find out more about the category and the disease, thereby raising sales of prescription drugs.

“After visiting an unbranded site, a significant share of consumers research more information about the condition itself as well as treatments for the condition,” Levy said. “That’s a positive indicator that these initiatives are working.”

Ken Frazier

• Merck upped Ken Frazier to president. He had been president of Global Human Health worldwide sales and marketing.
• PharmAthene appointed Mitchel Sayare to its board.
• Michael Marine joined the Sabine Vaccine Institute as CEO.
• Interleukin Genetics added William Mills to its board.
• Rigel Pharmaceuticals was named one of the recipients of the 2010 Innovators Award of Excellence by the San Mateo County Economic Development Association.
• VIVUS appointed Michael Miller SVP and CCO.
• Simbionix added Glen Mayfield and Raanan Cohen to its board.
• PharmAthene’s board upped Eric Richman to interim CEO.
• China Medicine appointed Fred Wai-Kuen Cheung its new CFO.
• Chimerix promoted Kenneth Moch from COO to president and CEO and added him to its board. The company also named George Painter chief scientific officer and chairman of the board.
• Genecor CEO Tjerk de Ruiter was elected chair of the industrial and environmental section of BIO, as well as its board.
• Fran Dramis joined US Oncology’s board.

FDA, on Monday, announced that it was reviewing whether a certain class of prostate cancer drugs could lead to diabetes, stroke, death, or heart problems.

The drugs in question are gonadotropin-Releasing Hormone (GnRH) agonists, marketed under a number of monikers, including Vantas and Lupron. These treatments are used to slow the growth of prostate cancer by decreasing the amount of testosterone created by the body.

“While our review of these prostate cancer treatments is ongoing and there are some limitations to the data, FDA believes it is important to tell patients and health care professionals that there may be an increased risk of serious side effects,” stated Robert Justice, director of the Division of Drug Oncology Products in FDA’s Center for Drug Evaluation and Research.

Doctors are being told not to suspend treatment, but to be aware of the risks and watch patients closely for diabetes of cardiovascular disease.

FDA Commissioner Margaret Hamburg announced, on Thursday, a new joint initiative between industry, FDA, and non-profit organizations designed to fast-track modern combination treatments for tuberculosis. Where once it took more than two decades to create new therapies for TB, this collaboration is expected to produce working treatments in less than six years, providing much-needed help for people developing nations.

Dubbed the Critical Path to TB Drug Regimens, this program will enable different stakeholders to share new compounds and ideas in an effort to shorten the time it takes to develop new multi-drug therapies. The initiative is spearheaded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the Global Alliance for TB Drug Development, with partners including members of FDA, the World Health Organization, Johnson & Johnson, Sanofi-Aventis, and Pfizer.

“FDA is absolutely committed to working with industry and other partners to speed access to new, safe, and highly-effective treatments for TB, which continues to mutate and spread,” stated Hamburg in a release. “I’ve seen first-hand the public health impact and personal tragedy of drug-resistant TB. This creative approach mirrors FDA’s own investments in innovative regulatory science that ensures the best new medical technologies—including combination therapies—reach patients as soon as possible.”

According to TB Alliance President and CEO Mel Spigelman, the catalyst for this collaboration was a critical mass of raw materials or substrate in the pharma pipeline.

“The real issue for TB has been that it’s a truly neglected disease, and until not that long ago no one was working on new drugs even though there was a clear need for it,” Spigelman said in an interview with Pharm Exec. “We presented this idea five years ago, but there simply weren’t enough compounds to work with.”

There are now nine compounds in clinical development for TB. This critical path is intended to get one or more new regiments registered and adopted as soon as possible.

What makes TB drug development so complicated is that treating the disease with a single drug almost always leads to treatment resistance (sometimes within as little as two weeks). While patients might feel better in the short term, the disease never really goes away. To completely defeat the TB, patients must be treated with a regimen of multiple drugs or a drug cocktail.

Traditionally, a company looking to add new drugs to a treatment regimen would have to spend a minimum of six years in testing. A Phase III study alone could take four years to show results. A pharma company trying to develop a cocktail of four treatments could feasibly spend up to 25 years testing each drug.

“Whether the combination happens to have one new drug in it or four new drugs, you are really testing that combination once you get beyond two weeks,” Spigelman said.

About two years ago, the TB Alliance began reaching out to different partners for research purposes and to look at combination of different drugs in animal models. The organization formed bilateral agreements with multiple sponsors and brought them into the initiative one by one to work with academic collaborators on testing preclinical combinations.

“We’ve already identified, in mice, at least 10 different regimens that look much better than the standard treatment,” Spigelman said. “That’s a building block that helps forge the pathway in the clinic.”

This type of approach could also be translated to other diseases such as malaria. HIV had a similar critical path in the 1990s, when a number of pharma companies share d  knowledge  as a springboard to get combinations developed more quickly.

SK&A released the results of its latest physician survey, and it turns out that most docs are happy to meet with sales reps as long as they make an appointment in advance.

In fact, 98 percent of offices that allow sales reps to make office calls see 20 reps per week.

“That’s how many reps step through the door,” said Jack Schember, director of marketing, SK&A. “And by that we mean reps that were allowed in to drop off promotional materials, drug samples for signature, attempt to see the physician, or have an appointment for a meeting.”

Schember admits that SK&A has no benchmark to compare the data against, as this is the first time that company has asked the question as part of its Physician Access Survey, which surveyed more than 200,000 medical offices.

There is no data on how many of these sales calls are repeat visits from the same rep, or what companies they represent.

Of the physicians interviewed, 49.6 percent said that they require an appointment to meet with a rep. That’s up from 38.5 percent in 2008. Doctors in smaller practices appear to be the most likely to demand appointments, but they are also more likely to meet with reps, because they own the practice.

On the other hand, “doctors in larger practices are requiring appointments because their policies are governed by corporate owners, such as medical groups and health systems,” Schember said. “In some cases, pharma reps have to apply through the corporate owner for clearance to visit a single office.”

Physicians in specialties such as diagnostic radiology, pathology, and neuroradiology are the most likely to deny all access to reps, while diabetes specialists are the most likely to meet with a rep. Just make sure to schedule an appointment ahead of time.