Imagine donating a sample of your DNA to help researchers study the genetics of diabetes. The disease is common among your friends and family, and you’re proud of your role in finding out why. Now, imagine that some time later, you learn that your DNA has been used for other studies on topics you never expected—schizophrenia, human migration, inbreeding. Although your name isn’t attached to the sample anymore, scientists are using your DNA to draw conclusions about your community and your ancestors. Some of these studies violate your cultural beliefs.

That’s what happened to the Havasupai Tribe of Arizona. In 2004, they sued Arizona State University, the institution that originally collected the DNA, for failing to provide ethical oversight on the use of the samples. The case is still working its way through the courts.

The lack of federal regulation in this and other instances of DNA use will be addressed in the Policy Forum section in the July 3 issue of Science by Sandra Soo-Jin Lee, PhD, of the Stanford Center for Biomedical Ethics, and colleagues from four other universities. The need for a clear set of rules governing genetic ancestry testing is becoming more urgent, Lee said, given the proliferation of private corporations that promise consumers insight into their genetic origins.

“Direct-to-consumer genetic ancestry tests fall into an unregulated no-man’s land,” Lee and her colleagues wrote, “with little oversight and few industry guidelines to ensure the quality, validity and interpretation of information sold.”

Genetic ancestry tests, which can cost just a few hundred dollars and require only a simple cheek swab, are gaining popularity among genealogy hobbyists and curiosity-seekers. But without clear rules and regulations, consumers may not be getting what they were promised. (Lee wrote specifically about the challenges posed by the direct-to-consumer genetic testing industry in the June 5 issue of The American Journal of Bioethics.)

In this new piece, Lee and her co-authors respond to recent testing guidelines issued by the American Society of Human Genetics to discuss more broadly how policies that govern ancestry testing, including genetics research, are insufficient. While the federal Office of Human Research Protections requires researchers to obtain consent from donors of DNA, the rules aren’t clear about how scientists can then use these samples. In the Havasupai case, for instance, samples weren’t tagged with individuals’ names, so scientists believed they were free to use them for later studies. The problem is that, because scientists can now identify the ancestry behind the DNA, such samples can be used to draw conclusions about small, possibly vulnerable groups of people.

According to Lee and her colleagues, developing a set of rules is challenging because of the diverse interests of the different groups involved in genetic testing: for-profit companies, academic scientists, casual consumers, Native American tribes and specific ethnic or racial subsets of the population. Oftentimes, conversations among these players can be muddied by unclear terminology and disagreements about the nature of concepts such as “origin.” To geneticists, that word might conjure visions of genetic markers, the authors wrote. But to Native Americans, “origin” might mean a location or landscape important to the tribe’s cultural identity.

To bring the sides together, the authors call for stronger federal oversight. “We encourage regulatory agencies such as the Federal Trade Commission, the Food and Drug Administration, and the Centers for Disease Control to help set industry standards for responsible and accountable practices in genetic ancestry testing,” said co-author Kimberly TallBear, PhD, assistant professor of science, technology and environmental policy at UC-Berkeley. Such leadership will be necessary, the authors wrote, in managing conflicts between groups that have given “little indication” that compromise will come easy.

The newest revolution in microbiology testing walks on four legs and says “baa.” It’s the hair sheep, a less-hirsute version of the familiar woolly barnyard resident. A new study from the Stanford University School of Medicine, which is to be published July 3 in PLoS ONE, finds that not only are these ruminants low-maintenance and parasite-resistant, they’re also perfect blood donors for the microbiology tests necessary to diagnose infectious disease in the developing world.

Identifying microbes from a patient’s urine or sputum requires growing those microbes in culture dishes filled with gelatinous agar and a small amount of blood. The blood provides nutrients to the growing bugs and also provides clues as to the microbes’ identities: Microbiologists can rule out or identify certain strains of bacteria based on how the organisms interact with the blood cells in culture.

In the developed world, microbiologists use sheep or horse blood. But in many parts of the developing world, horses are prohibitively expensive, and regular sheep, with their constant need for shearing and tendency to get infections, are difficult to keep alive. Importing animal blood isn’t feasible either, as shipping is costly and often unreliable.

Many labs in the developing world use human blood, often donated by lab technicians themselves. But diagnostic tests aren’t standardized for human blood, said Ellen Yeh, MD, a resident in pathology at Stanford and first author on the paper. “You don’t get the same test results when you use human blood versus sheep blood,” she said. In addition, the use of human donors increases technicians’ risk of infection with blood-borne diseases.

Ellen Jo Baron, PhD, professor of pathology at the medical school and senior author on the paper, wanted to do better. She’s a veteran of overseas microbiology, having trained lab technicians from Botswana to Cambodia for more than a decade.

“Up until the time I saw a hair sheep—which I first saw in Botswana—I had no idea there was even such a thing,” said Baron, who is associate director of Stanford’s clinical microbiology lab, interim director of the clinical virology lab, and associate chair of pathology for faculty development. She wasted no time in learning about the animals, finding that they resist parasites, don’t need to be sheared, and do well in the tropical climes prevalent in much of the developing world.

But no one had tested whether their blood was equivalent to horse or sheep blood. So, calling in a favor from a colleague with a hobby farm near Walnut Creek, Calif., Baron and her colleagues collected blood from hair sheep—the animals are remarkably mellow about the donations, she said—and created test cultures using the blood. Then, they ran a series of common diagnostic tests.

“It worked for every single thing,” Baron said.

The researchers also found that they could collect the blood in donation bags, much like those human donors might see at the Red Cross. That’s a big advantage over the defibrination process the developed world uses. To defibrinate blood, technicians must shake the samples in a glass jar filled with hundreds of tiny glass beads constantly during and after the donation. That’s fine in a lab with machines to do the shaking and autoclaves to sterilize all of those beads, but it’s an enormous burden in labs without that equipment. Fortunately, Baron found, hair sheep blood collected in donation bags performed the same as defibrinated blood.

“It’s very important,” said Bruce Hanna, PhD, professor of pathology and microbiology at the New York University School of Medicine, who was not involved in the study. “This paper found an alternative that is able to be produced in Africa and provides identical results to the standardized products that are used in this country.”

Michele Barry, MD, senior associate dean for global health at Stanford medical school, added: “Diagnosis of bacterial diseases and antibiotic sensitivity in low resource settings is often infeasible due to cost, access to diagnostics or manpower. Ellen Jo Baron and colleagues have uniquely decided to combine veterinary health science and human blood banking to develop a blood agar from hair sheep as medium to grow bacteria. This sheep is a low-maintenance animal adopted for hot climates. The technology, which they are modeling in Botswana, is an example of a practical ‘can do’ innovation in microbiology that will save lives in the tropics at low cost by quickly identifying bacteria to tailor cost-effective antibiotic use—a precious commodity overseas.”

Now, said Baron and Yeh, the only hurdle is getting the sheep to the labs that need them. Two veterinary labs in Botswana already provide hair sheep blood to local labs based on Baron’s initial results. Baron is now lobbying the charity Heifer International to add hair sheep to its catalogue so microbiologists can donate and send the animals to the developing world. After all, she said, the sheep can provide milk and meat—and that’s on top of their role as donors of blood that, in her words, “works perfectly for every microbiology test that a laboratory would need to do.”

New research from two Philadelphia-area cardiologists finds that an over-the-counter dietary supplement sold at pharmacies and health food stores may be an alternative for patients who cannot take traditional statin medications to lower cholesterol because of statin-related muscle pain. The findings of their study, “Red Yeast Rice for Dyslipidemia in Statin-Intolerant Patients,” appear in the June 16, 2009 issue of Annals of Internal Medicine.

Cardiologists David Becker, M.D., and Ram Gordon, M.D., Chestnut Hill Cardiology, studied 62 patients with high cholesterol in the first randomized, double-blinded placebo-controlled trial to evaluate red yeast rice in patients with a history of statin-associated myalgias (side effects that include muscle pain and weakness). Thirty-one of the patients took three 600-mg capsules of red yeast rice twice per day over the course of six months, and the other half received identical placebo tablets. The red yeast rice patients also participated in weekly meetings for the first three months, where they were taught about heart disease and how to incorporate heart-healthy nutrition, exercise and stress management into their lives.

At the conclusion of the study, the research found:

• Low-density lipoprotein cholesterol (also known as “bad cholesterol”) levels decreased more in the patients receiving the red yeast rice (average decrease, 35 mg/dL) than in patients receiving the placebo (average decrease, 15 mg/dL).
• Total cholesterol levels improved more in the red yeast rice group than in the placebo group.
• Muscle pain scores, weight loss, HDL cholesterol (high-density lipoprotein or “good cholesterol”) and liver or muscle enzyme levels did not differ between the two groups.

Red Yeast Rice, a staple of Chinese medicine for more than a thousand years, is derived from a fungus that grows on rice. A series of compounds within the red yeast rice have been found to slow the production of cholesterol in the liver. The medical community, however, has been slow to consider its potential use as an alternative treatment therapy for patients with statin-associated myalgias because the supplement is not regulated by the Food and Drug Administration.

“Every physician has patients who refuse to take statins or have significant side effects from them,” says Dr. Becker. “One of the largest challenges in the medical community has been that there is no agreement or consensus on how to treat these patients. We are convinced that our research may lead to some answers.”

Dr. Gordon remarked, “Statins have revolutionized the way doctors have taken care of cardiac patients over the past two decades. But for patients that cannot tolerate them, the side effects are considerable.” Some studies have estimated that up to 15% of patients taking the cholesterol-lowering drugs have to stop because of muscle pain. According to IMS Health, a drug tracking company, more than 200 million statin prescriptions were filled in 2008.

Dr. Gordon added, “While red yeast rice isn’t appropriate for everyone, the goal of our research was to see if it has potential to be an option for those patients who discontinue their statins because of the side effects. Often these patients with high cholesterol are left without lipid-lowering therapy. This is especially worrisome if the patient has a history of heart attacks, stents, bypass surgery or strokes.”

Dr. Becker and Dr. Gordon are in private practice at Chestnut Hill Cardiology in Flourtown, Pennsylvania, a suburb of Philadelphia and are on the staff of Chestnut Hill Hospital and Abington Memorial Hospital. They also conduct an innovative cardiac prevention program called “Change of Heart,” which was developed by Dr. Becker in 1993. The 10-week program takes a holistic approach to cardiac wellness, utilizing diet, exercise, stress management and traditional and alternative treatment therapies to help people reduce and even reverse the effects of coronary artery disease.

Dr. Becker said, “Our present medical system places very little emphasis on educating patients. We employ a team approach. Patients work closely with dietitians, fitness experts and stress management counselors, and we provide the physician perspective to help them evaluate and consider traditional treatment and alternative therapies. We passionately believe that patients need to take control of their cardiac destiny.”

“Aside from its findings, this study is unique because it is truly rooted in our community rather than the commercial interests of pharmaceutical companies,” says Brooks Turkel, CEO of Chestnut Hill Hospital. “The premise of the research was established because local patients inquired about alternatives to cholesterol lowering drugs and the potential undesirable side effects. Our cardiologists, motivated to provide their patients with alternatives, developed a life-style modification program, Change of Heart, which has served as a springboard for further research involving natural supplements. We at Chestnut Hill Hospital are very proud that the research by Drs. Becker, Gordon and their team has gained the recognition of the national medical community.”

“Chestnut Hill Hospital has received funding for this study through a grant from the Commonwealth of Pennsylvania,” notes Mr. Turkel. “We are grateful that our state representatives saw the value of the Change of Heart program.”

Online comments and product reviews influenced 65% of U.S. adults who recently used a diet or weight loss program, according to the Spring 2009 Ad-ology Media Influence on Consumer Choice survey.  These consumers are very interested in the effectiveness of diet programs and are actively seeking out the opinions of other users.

Online media also impacts health/fitness club choice, especially among the 18-to-24-year-old demographic (60.8%).

Of health club members, 89% say variety of equipment is an important factor in their selection decision, and 88% say the same for quality of equipment. Looking at factors by gender, women are more interested in the variety and availability of classes, while noticeably more men want to work out where their friends/family go, perhaps because men view working out as a social experience.

For the vitamin and nutritional supplement market, one in five consumers prefers to shop at a specialty health food/vitamin store, with 35-to-44-year-olds most likely to seek out these stores. More than 60% of that age group cite brand name as an important factor in their purchase decision and are most likely to be influenced by manufacturer Web sites.

“Consumers are researching diet and other wellness topics online much like they would research a consumer electronics purchase,” said C. Lee Smith, president and CEO of Ad-ology Research. “Anybody in this industry must maintain a strong online presence to provide the information these health-conscious consumers crave,” Smith said.

Other key findings from the survey:

• For health/fitness clubs or gym choice, direct mail was the most influential traditional media type
• Television was the most influential traditional media for 18-to-24-year-olds looking for diet and weight loss products and services
• Of traditional media, newspapers had the most influence (35.3%) on recent over-the-counter vitamin or nutritional supplement purchasers
• 12% of Hispanics researched personal trainers online, the most among all ethnic groups

Results of the HIGHCARE2008 Project were announced during the recent 19th Scientific Meeting of the European Society of Hypertension (ESH), Milan, Italy. The first-ever ambulatory blood pressure (ABPM) study conducted at high and very high altitude investigated treatment with telmisartan and showed that:

• in conditions of hypobaric hypoxia (oxygen deficiency), 24-hour blood pressure increased in a sustained manner proportional to the altitude reached
• the effects of hypobaric hypoxia at high altitude are similar to the effects of reduced oxygen availability observed in diseases associated with respiratory disorders, such as chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), arterial hypertension related to sleep apnea syndrome and/or severe obesity.^2-5 Together, these diseases affect more than 600 million people worldwide^6,7 giving the study results great significance
• treatment with telmisartan, a modern angiotensin II receptor blocker, reduces blood pressure compared with placebo at high altitude, up to at least 3500m above sea level, demonstrating potential control of hypoxia-induced blood pressure alterations
• at very high altitude, 5400m above sea level, blood pressure effects between the telmisartan and placebo groups was comparable, consistent with changes in the functioning of the renin-angiotensin-aldosterone system (RAAS).

Physiological changes occurring at high altitude are mainly due to decreased atmospheric pressure leading to hypoxia (deprivation of adequate oxygen supply) and hypoxemia (decreased partial pressure of oxygen in blood).

Professor Gianfranco Parati, Chairman and Principle Investigator of the HIGHCARE2008 Project and Professor of Medicine at the Department of Clinical Medicine and Prevention, University of Milano-Bicocca commented, “People with sleep apnea syndrome develop high blood pressure in response to hypoxia, a lack of oxygen in their blood. In the HIGHCARE2008 Project, this condition has been simulated by hypobaric hypoxia, often associated with sleep-related breathing disorders, which occurs at high altitude. We found that telmisartan – the antihypertensive drug we tested – was able to control this effect at altitudes of up to 3500m, at which the lack of oxygen is similar to the degree of hypoxemia most commonly experienced by sleep apnea sufferers.”

The randomised, parallel group, double-blind, placebo-controlled trial with telmisartan 80mg was conducted in 38 healthy subjects with a moderate level of physical fitness. The effects of telmisartan on 24-hour ambulatory blood pressure were measured under acute and prolonged exposure to high altitude hypoxia. Key results showed that:¹

• following treatment with telmisartan for six weeks at sea level and also following acute exposure to high altitude (3500m):

• 24-hour SBP/DBP^** at sea level were significantly reduced with telmisartan compared with placebo (SBP: 112.0±7.8 vs. 116.4±8.6, p=0.0025; DBP: 69.0±5.8 vs. 74.0±5.8, p=0.002)

• 24-hour SBP/DBP at 3500m were also significantly reduced with telmisartan compared with placebo (SBP: 120.0±9.7 vs. 125.0±8.7,p=0.0056; DBP: 75.7±6.5 vs. 81.1±5.7, p=0.009)
• at very high altitude, 5400m, 24-hour SBP/DBP was comparable between the telmisartan and placebo groups (SBP: 130.1±11.1 vs. 130.7±11.2, p=NS; DBP: 82.1±7.1 vs. 84.2±6.6, p=NS), consistent with changes in functioning of the RAAS. These changes may explain why a treatment that works on the RAAS may not provide benefits at very high altitude.

The RAAS is involved in the occurrence of a number of cardiovascular (CV) conditions, including hypertension and heart failure. Therapeutic agents acting on the RAAS, including angiotensin II receptor blockers such as telmisartan, have beneficial CV effects.

Dr. Grzegorz Bilo, Istituto Auxologico Italiano and Department of Clinical Medicine and Prevention, University of Milano-Bicocca, commented, “When moving to an even higher altitude, and thus further increasing the hypoxia above the levels often experienced in sleep apnea, the blockade of the RAAS was no longer able to control the hypoxia-induced blood pressure increase. This suggests that other mechanisms were involved and could explain the blood pressure changes observed. Even though this is an artificial setting, the data we have collected will provide important insights into the physiological and molecular basis of hypoxia induced hypertension.”

Professor Gianfranco Parati concluded, “While the data that we have collected need to be confirmed by further studies, what we can take away from this expedition is that although Everest is one of the most hostile places on earth, it might actually help us save lives by giving us a better understanding of the changes induced by hypoxia in the human body”.

^* HIGHCARE = HIGH altitude CArdiovascular REsearch

^** SBP – systolic blood pressure; DBP – diastolic blood pressure

Following the recent swine flu outbreak and resulting turmoil, many organizations are assessing whether they’re fully prepared to handle such a widespread business disruption. Pandemic-proof communications are critical to understanding how the outbreak is impacting the workforce and what adjustments should be made to keep the business going. Two-way communication via multiple channels is by far the most effective way of reaching all stakeholders and giving employees the means to report on their status—both of which will help companies mitigate the financial and operational impact created by a prolonged outbreak.

Varolii Corporation, one of the largest providers of automated communications nationwide, offers the following eight recommendations on how best to communicate during a pandemic:

1. Be proactive, rather than reactive. Proactive communication heads off rumors, panic and misinformation, so don’t wait for employees to ask for information. Let them know you have a plan in place, what their options are for telecommuting, and what they can expect if an actual pandemic hits.
2. Update employee contact information now. If you can only reach employees through their work phone or email, you have a problem. During a pandemic, they may not have access to either one. Have your employees update all their contact information in your database, including personal mobile and home phone numbers, personal email accounts and other emergency contact information. Ideally, your communications system will automatically check for recent updates before sending out a critical message.
3. Use multiple communication channels. On any normal workday, many of your employees may be working remotely, traveling on business or on vacation. During a pandemic, up to 40 percent may be ill or quarantined away from home. You can’t rely on just one communication channel. Use a combination of landline, mobile phone, text messaging and email, and make sure your employees know it’s you calling. Otherwise, they may never pick up the phone or respond.
4. Leverage two-way communication. While outbound communication is critical, it’s only half of the equation and doesn’t give you enough information to keep your business running. Give employees multiple ways to keep you informed of their status. For example, are they coming to work? Are they taking care of loved ones or sick themselves? Two-way text messaging is especially effective for brief status updates or to tell employees they can retrieve a new companywide update online or via voice message at their convenience.
5. Don’t assume a single message will do the job. If an employee doesn’t answer, how do you know whether it’s because they’re too sick to answer or just briefly away from their phone? Sending a sequence of different messages across multiple channels that acknowledge previous communications can help. For example, consider sending a text message that references a previously unanswered phone call. Employees will then understand why additional messages were sent and what action to take.
6. Communicate the way your employees want you to. If you can track your employees’ preferences and how they’ve responded to past communications, you’ll not only be ahead of the game in getting their attention, you’ll be able to tell if their current behavior is typical or an indication something may be wrong. For example, don’t call a night-shift employee at 9 a.m. right when they’re drifting off to sleep. Either call later in the day or send a silent text message.
7. Don’t forget your customers. Just as it’s important to communicate with your employees during a crisis, you should also keep your customers informed. Assuring them of how your business is continuing to operate will reduce confusion and let them know they can depend on you. If your communication system automatically checks for contact information updates in your customer relationship management (CRM) system and sends an automated message to customers, that’s one step you won’t have to manually undertake.
8. Call in an expert. If the first seven tips seem overwhelming, consider automating your critical communications, perhaps even outsourcing it to an automated communications provider. The most effective solution will:

• Integrate with employee and customer databases in real time so your message gets through
• Enable both inbound and outbound communication across multiple channels to share the most up-to-date information in both directions
• Incorporate individual preferences and learn from past responses to ensure you get recipients’ attention and can assess whether current behavior indicates something is wrong
• Implement quickly and easily – well before a pandemic hits.

Sense of smell? … I never gave it a thought. You don’t normally give it a thought. But when I lost it – it was like being struck blind. Life lost a lot of its savour – one doesn’t realize how much “savour” is smell. You smell people, you smell books, you smell the city, you smell the spring – maybe not consciously, but as a rich unconscious background to everything else. My whole world was suddenly radically poorer…” (from: Sacks O., 1985, The dog beneath the skin. In: The man who mistook his wife for a hat. Summit Books / Schuster & Schuster Inc., New York)

A rose by any other name may not smell as sweet if you simply can’t smell it. We never think our sense of smell is particularly important to our quality of life, until something happens and we loose it. The sense of smell is in the news right now citing people who have lost theirs and realize just how diminished their quality of life is without it.

Without consciously being aware of it, we smell every time we take a breath: other people, newspapers, books, the city, the spring air, food and of course fragrances in all forms. The Sense of Smell Institute, the research and education division of The Fragrance Foundation, is a leading resource for understanding this least understood of our five senses. The sense of smell affects every facet of our lives. Even our sex lives! In her book, The Scent of Desire, Rachel Herz, an expert on the psychology of smell, looks at the role of scent in sexual attraction, based on years of research. “Body chemistry plays a large role in terms of whom we are sexually attracted to and our noses speak loudly to our souls”, she says.

Drs. Thomas Hummel and Steven Nordin of the Smell and Taste Clinic at the University of Dresden Medical School recently completed a white paper for the Sense of Smell Institute entitled “Quality of life in olfactory dysfunction,” that provides a comprehensive review of the recent research on the causes of the loss of the sense of smell and its effect of quality on life.

In it they note that, “loss of olfactory function is frequent. While it frequently goes undetected in most of these patients, and almost all of them continue their social and professional activities, it may severely alter the quality of life of these people.” Problems typically reported are primarily in the areas of safety and eating, but olfactory loss can also produce a feeling of insecurity (for example, as one’s own body odors are no longer perceived).

So while most of us may think the sense of smell is the least important of our five senses, research proves just the opposite:

The sense of smell plays a vital role in our sense of well-being and quality of life.

The sense of smell brings us into harmony with nature, warns us of dangers and sharpens our awareness of other people, places and things. It helps us to respond to those we meet, can influence our mood, how long we stay in a room, who we talk to and who we want to see again.

The average human being is able to recognize approximately 10,000 different odors.

Our sense of smell is so powerful that when you smell skunk, you are smelling 0.000,000,000,000,071 of an ounce of scent. Dogs have about 200 million olfactory receptors. That is about 20 times the number of receptors that humans have.

It is important to understand that throughout every day and night of our lives we smell a wide variety of odors without being aware of them at all.

We go about our activities, breathing in and out, as an infinite number of chemical molecules interact subliminally with our odor receptors. Only when an odor irritates or pleases us or acts as a sudden reminder of the past do we pause to take notice.

Comparative effectiveness research is generating buzz these days, with the recent economic stimulus package allocating $1.1 billion for these types of studies. But a researcher at the Stanford University School of Medicine is asking policymakers to take a step back and make sure that the plans for comparative effectiveness research go deep enough to make a difference.

“The discussion that has taken place has been quite superficial and hasn’t covered the range of changes that are needed for this type of research to be meaningful,” said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center.

The Obama administration sees comparative effectiveness research as a key strategy for reforming the nation’s health-care system. The research would help identify the treatment options that are the most effective for a given condition. Many stakeholders, including health-care providers, consumer groups and professional organizations, have also expressed enthusiasm at the prospect of identifying new knowledge about how the effectiveness of one treatment compares with others.

Despite this potential, Stafford and collaborator Caleb Alexander, MD, assistant professor of medicine at the University of Chicago, highlight several challenges that must be met if comparative effectiveness research is to be useful in significantly improving the quality and affordability of health care. “This is really a plea to delve into the details, to get beyond the slogan of ‘comparative effectiveness’ and to not lose the momentum gained to date,” Stafford said.

Stafford and Alexander’s commentary, which will appear in the June 17 issue of the Journal of the American Medical Association, outlines five ways to put more meat on the bones of the discussions surrounding comparative effectiveness research:

Generate the data more rapidly. The pain reliever Vioxx is the best-known example of a drug originally aimed at a narrow patient population that became widely prescribed before evidence of harm was discovered. Ultimately, Vioxx was pulled from the market, but not before millions were exposed to these harms without substantial benefits. To prevent similar mishaps, Alexander said that obtaining comparative-effectiveness information earlier in the life of a new drug or device is a priority.

Link the evidence to strategies proven to modify how physicians practice medicine. Simply making the data available to physicians and patients isn’t enough. “Unfortunately, we still want to believe that information alone will change physician practice. Years of research, however, suggest there are more potent influences on physicians, including their local culture of practice,” Stafford said.

Broaden the agenda beyond drugs and devices. “It can’t just be a comparison of this drug vs. that drug,” Stafford said. “This misses important aspects of practice and ends up exempting high-cost procedures from scrutiny.” Researchers should focus on comparisons that include lifestyle modifications, such as diet and exercise, as well as alternative therapies that patients often implement on their own. In addition, research is needed on the most effective ways of delivering care. For instance, some studies show better chronic disease outcomes with nurse case managers compared with physicians working alone.

Alter the regulatory environment. “Comparing a new drug against placebo doesn’t make much sense if our goal is to compare different clinical strategies,” said Stafford, noting that placebo-controlled trials are the standard for drug approval by the U.S. Food and Drug Administration. The threshold must be raised for comparative effectiveness to work, he said. Stafford and Alexander suggested that if a new medication isn’t tested head-to-head against similar drugs, its labeling could be changed to say, for instance, “This drug has not been found to be superior to the other calcium-channel blockers in the treatment of hypertension.” This requirement would provide useful information to patients and physicians, as well as give manufacturers an incentive to perform more drug vs. drug clinical trials.

Consider the cost implications. This is controversial because many fear that it may lead to restrictions on higher-cost treatments, regardless of the treatment’s effectiveness. Some proponents of comparative effectiveness research have suggested not including cost as a factor. But as Stafford and Alexander write in their commentary, “What good is comparative effectiveness if it cannot be used to discern anything about value to clinicians, insurers, patients and society?”

The discussions surrounding how to implement comparative effectiveness research data into the health-care reform effort are still in the early stages, which is why Stafford and Alexander hope their commentary will prod policymakers to ensure that the discussions are as comprehensive as possible.

Stafford said previous reform attempts, such as the drive to develop clinical guidelines in the 1990s for treating specific illnesses, failed because “our approach to implementing them was simplistic and not sophisticated enough. Unless we get it right with comparative effectiveness, it’s at risk of a similar fate.”

Stafford and Alexander support efforts to help physicians and patients make better use of research results in determining which drugs, devices and other treatment options are the most effective. “The drive for comparative effectiveness has tremendous appeal. Who could argue against the idea of generating knowledge about what works and what doesn’t?” said Alexander. But they say broader changes are needed in the health-care system—including the FDA’s process for approving new medications and devices—to yield the right kind of data for such comparisons, and to ensure that patients, physicians and medical organizations make the wisest possible use of their health-care dollars.

“Unless we start spending our resources more efficiently, our health-care system won’t survive, let alone fully cover all of the people who are now uninsured or underinsured,” Stafford said.

The link between a person’s diet and his or her mental health is becoming more and more relevant. According to The Mental Health Foundation, evidence suggests that a healthy diet is instrumental in the treatment and prevention of mental health disorders such as depression, schizophrenia and attention deficit hyperactivity disorder. Studies have shown that treatments utilizing nutrients such as zinc, vitamins B1, B2 and C, see greater relief of symptoms in people with depression and bi-polar disorder by as much as 50 percent.

“A balanced mood and general feeling of well-being can be enhanced by a nutritious diet,” said Jacqueline Dawes, owner and founder of Brookhaven Retreat, a multidisciplinary treatment facility that has incorporated a spa cuisine menu into its care programs. The menu appeals to the five senses and addresses nutritional needs and adequacy. “A healthy diet does more than reduce the risk of physical conditions, such as heart disease and diabetes. It also plays a vital role in emotional and mental health. Facilities that do not see diet as a piece of the treatment puzzle are missing a vital aspect of care,” said Dawes.

According to Teran Moon, Registered Dietitian and Licensed Nutritionist at Brookhaven Retreat, food can be used as a pharmaceutical compound to positively affect the entire body, especially the mind. “A diet that is lacking in nutrients needed for healthy brain function, such as omega-3 fatty acids, can cause the brain to function abnormally, working as a barrier towards mental health treatment.”

Mandie Brokaw, culinary consultant, and Ryan Martin, lead chef, have created for Brookhaven Retreat a specialized, nutritionally fortified menu. They work closely with Moon to ensure the menu meets heart health guidelines, daily dietary exchanges and balanced nutritional content. “The culinary team works hard to incorporate menu requests from the clients, while maintaining a standard of focused nutrition and elegant presentation,” said Moon.

“The menu that has been created exclusively for Brookhaven Retreat works to improve more than just mental health. Our expert culinary team has also created gourmet dishes that improve heart-health and full body well-being,” said Dawes. “Our holistic approach to treatment nurtures all levels of recovery, including spiritual, physical and mental. Our menu is one way our clients achieve the necessary release from toxins stored in the body as well as the mind and emotions.”

As studies continue to prove the strong correlation between a healthy diet and a healthy mind, treatment centers will need to follow Dawes’ lead, and that of Brookhaven Retreat, by incorporating nutrition into care programs.

Could your car be a self-contained isolation compartment when you seek medical attention during a pandemic? And, is a drive-through approach an effective method to triage and screen a large number of patients? These possibilities will be tested in an exercise to compare actual times and outcomes of a drive-though method to the standard walk-in approach that was used at Stanford Hospital and throughout the country during the recent H1N1 event.

The exercise will be held Friday, June 12 (8 a.m. – 11:30 a.m.) on the Stanford University campus at Parking Lot 5 on Oak Road, near Stock Farm Road (see directions below). Media are invited to attend.

The exercise will be the first test of its kind in the U.S. Federal officials hope to incorporate its results into a protocol useful for all U.S. hospitals facing pandemic emergencies. Stanford’s data will be used to build a computer simulation. Eric Weiss, MD, Medical Director for Disaster Planning, Stanford Hospital & Clinics and Lucile Packard Children’s Hospital, and his colleagues have teamed with the U.S. Centers for Disease Prevention and Control to design the exercise and create the list of data to be collected.

Throughout the exercise, all medical personnel will be gowned, gloved and masked. More than a dozen physicians and nurses will be positioned at the various screening and treatment stations. Portable digital monitors will be ready. Blood and other specimen testing will be done with a portable lab. The exercise will also test the drive-through plan as a potential mechanism for dispensing medications or administering vaccines. Other health care professionals will act as observers and evaluators. Officials from the Santa Clara County Public Health Department will also be on hand.

“The main idea is to avoid infection,” Weiss said. When SARS emerged in Toronto, five hospitals had to close because people with the illness came into emergency rooms and infected others, as well as health care workers. “We feel that this mechanism of screening and evaluating patients during a pandemic will be safer for both patients and healthcare providers and much faster than traditional methods.”

Directions: From Hwy 101 – University exit towards Stanford; Rt. on El Camino, Lt. on Sand Hill Rd., Lt. on Stock Farm Rd., Rt on Oak Road.

Directions from Hwy 280 – Sand Hill Rd. exit; Rt. on Stock Farm, Lt. on Oak Road