Hepatitis model: Human liver cells (in green) that are injected into mice take over, creating a mostly human liver. When infected with hepatitis B, scientists can study its effects in vivo and test new drugs on the “humanized” liver.
Credit: Karl-Dimiter Bissig, Salk Institute for Biological Studies

Rodents could be an effective model for researchers looking for new hepatitis drugs

MIT Technology Review, February 23, 2010, by Jennifer Chu  —  Scientists at the Salk Institute for Biological Studies have engineered a mouse with a mostly human liver by injecting human liver cells, or hepatocytes, into genetically engineered mice. Researchers say the mouse/human chimera could serve as a new model for discovering drugs for viral hepatitis, a disease that has been notoriously difficult to replicate and study in the lab. The team exposed the altered mice to hepatitis B and C viruses and, after treating the rodents with conventional drugs, found that the mice responded much like human patients.

In the United States, 1.2 million Americans are infected with chronic hepatitis B, and 3.2 million with chronic hepatitis C. Searching for effective treatments and drug combinations for viral hepatitis has been a frustrating challenge for years.

In the laboratory, hepatitis and the liver cells it infects can be cagey and temperamental. Human liver cells immediately change character when taken out of the body, and are difficult to grow in a petri dish. What’s more, hepatitis only infects humans and chimps, having virtually no effect in other species, meaning conventional lab animals like mice and rats are useless as live models. “You could do chimp studies, but that is not very convenient, and it is of course an ethical issue,” says Karl-Dimiter Bissig, first author of the group’s paper, published in the Journal of Clinical Investigation. “There’s really a need to develop animal models where you can make a human chimerism and study the virus.”

Bissig says his group’s mouse/human chimera improves on a similar model developed several years ago that was genetically engineered to give human liver cells a growth advantage when injected into a mouse liver. Researchers engineered the mouse with a gene that destroyed its own liver cells. This programmed death gave human liver cells an advantage, and when researchers injected human hepatocytes, they were able to take over and repopulate the mouse liver. However, scientists found that the genetically engineered mice tended to die off early, which required injecting human liver cells within the first few weeks after birth–a risky procedure that often resulted in fatal hemorrhaging.

Instead, Bissig and his colleagues, including Inder Verma of the Salk Institute, sought to engineer a mouse chimera in which the introduction of human liver cells could be easily controlled. The group first engineered mice with several genetic mutations, which eliminated production of immune cells so that the mice would not reject human liver cells as foreign. The researchers made another genetic mutation that interfered with the breakdown of the amino acid tyrosine. Normally, tyrosine is involved in building essential proteins. To keep a healthy balance, the liver clears out tyrosine, keeping it from accumulating to toxic levels. Bissig engineered a mutation in mice that prevents tyrosine from breaking down, instead causing tyrosine to build up in liver cells, eventually killing the mouse cells, giving the human cells an advantage.

To avoid killing mouse liver cells too early (or killing the mice entirely), Bissig’s team administered a drug that blocks the toxic byproducts of tyrosine buildup from killing liver cells. By putting the mice on the drug, and taking them off the drug a little at a time, researchers found that they could control the rate at which rodent liver cells died off.

The team then injected mice with hepatocytes from various human donors, and found that the cells were able to take over 97 percent of the mouse liver. The “humanized” mice were then infected with hepatitis B and C, and researchers found high levels of the virus in the bloodstream–versus normal mice, which are impervious to the disease and are able to clear the virus out quickly.

Bissig and his colleagues went a step further and treated the infected mice with a drug typically used to treat humans with hepatitis C. They found that, after treatment, the mice exhibited a thousand-fold decrease in viral concentration in the blood, similar to drug reactions in human patients.

Charles Rice, who heads the laboratory for virology and infectious disease at Rockefeller University, says the new chimeric model is a robust improvement over existing study models for viral hepatitis. Further improvements, Rice explains, could include engineering human cell types, other than hepatocytes, that also appear in the human liver. While the majority of the human liver is composed of hepatocytes, there are a few other cell types that may interact with hepatocytes and affect how a virus infects the liver. Engineering other liver cells could more accurately depict a working human liver and its response to disease.

Raymond Chung, associate professor of medicine at Harvard Medical School, suggests another improvement in designing an accurate mouse/human liver: to engineer a mouse with a human immune system. “This is still not an ideal model,” says Chung of Bissig’s research. “You can’t necessarily accurately evaluate antiviral drugs given the lack of adaptive immune response in these animals.”

Bissig says that in the future, he and his team hope to add a human immune system to their mouse model, so they can see how hepatitis acts, not only in a human liver, but in the presence of a normal, healthy human immune system.

Harvard Medical School

 

FiercePharma.com, February 23, 2010, by Tracy Staton  —  A new survey quantifies a trend we’ve seen: Fewer medical schools are accepting gifts and support from drug and device makers. According to the study published in the Archives of Internal Medicine, 56 percent of internal medicine program directors say they accepted free food and teaching materials. That’s down from 89 percent in 1990.

And apparently, some of the program directors are accepting pharma support unwillingly: Seventy-two percent say taking offered food and gifts from drugmakers was undesirable.

The ties between medical schools and drugmakers have come up for plenty of debate in recent years. Some colleges–including, most recently, Harvard Medical School–have instituted new, more restrictive policies governing just what sort and how much aid they can take from companies. Some of those policies even ban small gifts such as pizza; some won’t let pharma reps distribute free samples directly to doctors’ offices.

Researchers now are suggesting that perhaps med-school students need to be taught how to work with drugmakers. “Despite the attention around conflict of interest with pharmaceutical support, we were surprised to find that only 29.2 percent of the responding program directors reported a specific curriculum to instruct residents about interactions with the pharmaceutical industry,” the researchers say.

TheWallStreetJournal.com, February 23, 2010, by Anna Wilde Mathews  —  If you’re taking a daily aspirin for your heart, you may want to reconsider.

For years, many middle-aged people have taken the drug in hopes of reducing the chance of a heart attack or stroke. Americans bought more than 44 million packages of low-dose aspirin marketed for heart protection in the year ended September, up about 12% from 2005, according to research firm IMS Health.

Now, medical experts say some people who are taking aspirin on a regular basis should think about stopping. Public-health officials are scaling back official recommendations for the painkiller to target a narrower group of patients who are at risk of a heart attack or stroke. The concern is that aspirin’s side effects, which can include bleeding ulcers, might outweigh the potential benefits when taken by many healthy or older people.

“Not everybody needs to take aspirin,” says Sidney Smith, a professor at the University of North Carolina who is chairing a new National Institutes of Health effort to compile treatment recommendations on cardiovascular-disease prevention. Physicians are beginning to tailor aspirin recommendations to “groups where the benefits are especially well established,” he says.

Doctors generally agree that most patients who have already suffered a heart attack or ischemic stroke, the type caused by a clot or other obstruction blocking an artery to the brain, should take regular low-dose aspirin. But for people without heart disease, the newest guidelines from the U.S. Preventive Services Task Force spell out much more clearly than before when aspirin should be administered.

The guidelines, announced last year, suggest aspirin for certain men 45 to 79 years old with elevated heart-disease risk because of factors like cholesterol levels and smoking. For women, the guidelines don’t focus on heart risk. Instead, the task force recommends certain women should take aspirin regularly if they are 55 to 79 and are in danger of having an ischemic stroke, for reasons that could include high blood pressure and diabetes.

The panel urged doctors to factor in conditions that could increase a patient’s risk of bleeding from aspirin, which tends to rise with age. The group didn’t designate a dose, but suggested that an appropriate amount might be 75 milligrams a day, which is close to the 81mg contained in low-dose, or “baby,” aspirin. The task force didn’t take a position on aspirin for people who are 80 and older because of a lack of data in this age group.

Other medical researchers dispute the idea that there should be different guidelines for men and women. Still, many experts agree that doctors may have been recommending aspirin to people for whom the risks might outweigh the benefits.

Aspirin acts as a blood thinner, which is believed to account for much of its benefit of protecting against heart attacks and strokes. But that same action, along with a tendency to deplete the stomach’s protective lining, can lead to a danger of gastrointestinal bleeding and possibly bleeding in the brain.

The task force issued its latest guidelines after reviewing the evidence from a number of studies on aspirin’s benefits and risks. The recommendations update the panel’s previous guidelines from 2002, which were more broadly written. Those suggested aspirin use for people of any age who were at elevated risk of heart disease.

“We would like doctors to re-look at their patients who are on aspirin and consider recommending stopping it where the chance of harm outweighs the benefit,” says Ned Calonge, a Colorado public-health official who serves as the task force’s chairman. He notes, however, that in studies of healthy people taking aspirin, the actual rates of bleeding and of prevented heart attacks were very low.

Not all patients accustomed to taking aspirin will want to stop. Maxine Fischer, 55 years old, recently figured out that under the new U.S. guidelines, she wouldn’t be encouraged to continue with the drug. Using an online calculator, which factored such data as her age, blood pressure and medical history, she learned she had just a 1% likelihood of a stroke in the next 10 years. Under the guidelines, only women in her age group with at least a 3% or higher stroke risk should take aspirin.

Ms. Fischer, who works as a manager for seniors’ lobby AARP in San Diego, has taken aspirin daily for two years after reading it could reduce the risk of stroke. For the moment, she says she’ll keep it up, partly because she’s more worried about strokes than ulcers. Strokes are “the big scary thing,” she says.

Other patients say they would stick with aspirin because of other benefits attributed to the drug; past research has suggested that regular aspirin may reduce the risk of colon cancer, for instance. Virginia Douglas, 64, a retired trade-association executive, takes aspirin a few times a week. In addition to the possibly reduced risk of stroke, Ms. Douglas hopes to avoid colon cancer, which affected her father and grandfather. “There’s always a new study with a new recommendation,” says Ms. Douglas, of Sacramento, Calif. “You have to do what’s best for you.”

In a separate analysis, published in medical journal Lancet last May, an international group of scientists reached a broadly similar conclusion as did the U.S. task force—that doctors may have been recommending aspirin too widely. “You really have to have a clear margin of benefit over hazard before you should be treating healthy people,” says Colin Baigent, a professor at Oxford University who coordinated the Lancet analysis.

Still, the Lancet authors disagreed with the U.S. panel on some important details, particularly about who should be taking aspirin. The two groups examined evidence largely from the same studies of the drug, although the international team analyzed the data differently. In the end, the international team of scientists, unlike the U.S. officials, concluded that aspirin’s effects on men and women were mostly the same.

Another disagreement between the two groups also emerged: The U.S. task force said that age is the biggest factor determining a person’s risk of internal bleeding from aspirin. But the international team said other factors, such as diabetes and high blood pressure, also play a significant role. Unfortunately, the scientists noted, the same factors that increase patients’ risk of bleeding also increase their risk of developing heart disease. This, in turn, can make it more difficult to calculate whether the benefits of aspirin would outweigh the risks of side effects.

The U.S. task force responded with a letter to the Lancet, defending its finding that men and women’s results did appear different. There is a “wealth of evidence that men and women have different cardiovascular disease manifestations and respond differently to aspirin,” the letter said. The panel also reiterated its position that bleeding risk is best parsed by age.

Amid the debate, some individual doctors are finding their own position. Rodney Hayward, who codirects a Veterans Affairs research center in Ann Arbor, Mich., says he’s not convinced that aspirin’s effects on men and women are so different. He says he continues to recommend aspirin for certain patients of both sexes with significant heart risk.

Write to Anna Wilde Mathews at anna.mathews@wsj.com

What Aspirin Does

Aspirin’s effects in the body can have good and bad implications.

  • Blood thinner: It inhibits clotting, which helps reduce the risk of heart attack and ischemic stroke but increases the danger of bleeding.
  • Inflammation reducer: It lessens pain and fever by preventing production of the hormone-like substances called prostaglandins. But this can also deplete a protective layer in the stomach and increase the risk of ulcers.

What You Can Do

If you want to figure out if the newest guidelines recommend aspirin for you, here’s where to check:

  • At ahrq.gov, type ‘aspirin and prevention’ into the search box, and the new guidelines will come up in the results. Click on ‘clinical summary’ for a table that explains what people of different ages should do, and includes links to online calculators to help you figure out your risk of heart attack or stroke. You should also speak to your doctor.

Aspirin Advice

Doctors have been scaling back their aspirin recommendations for people who don’t already have heart disease. Here are the current guidelines from the U.S. Preventive Services Task Force.

Aspirin recommended for:

  • Some men 45 and older with risk factors for heart disease, assuming no history of ulcers or other bleeding dangers.
  • Some women 55 and older with risk factors for stroke, and no history of bleeding danger.

Aspirin not recommended for:

  • Men younger than 45, and women younger than 55.
  • Anyone 80 and older.

Anatomy of the Heart

Harvard Medical School, February 23, 2010 — Women and men share most risk factors for heart disease — including high chole
sterol, inactivity, obesity, high blood pressure, and smoking — but there are some gender differences in its development, symptoms, and prognosis.

Men and women who want to live a heart-healthy life together can devise a single diet and exercise program that will suit them both. But their paths diverge at pill time and cocktail hour.

Aspirin. Baby aspirin should have a place on a man’s medicine shelf 10 years before a woman’s. Men at risk for heart attack are advised to take a low-dose aspirin daily starting at age 45, but women are told to hold off until they’re 55, and then to take it for the purpose of preventing strokes. For both genders, the protective effects of aspirin have to be weighed against the gastrointestinal risks.

Alcohol. While two drinks a day may keep a man’s cardiologist away, they may hasten a woman’s journey to the ER. Women are limited to a single drink because their bodies hang on to alcohol longer: lower levels of the liver enzymes that break down alcohol keep concentrations in a woman’s blood higher for longer periods. As a result, alcohol abuse has more serious effects on women’s hearts than on men’s, as evidenced by studies of patients with alcoholic cardiomyopathy — a weakening of the heart muscle.

Differences in symptoms

When the coronary arteries are obstructed or constricted so that the heart muscle isn’t receiving the oxygen it needs to do its work, the body feels the results. Both men and women may experience angina, the classic sign of coronary artery disease characterized by chest pain, a cold sweat, nausea, and other symptoms.

But women are more likely than men to have less dramatic symptoms, such as general fatigue and a flulike malaise. And variant angina — also known as Prinzmetal’s angina — which results from coronary artery spasm and is likely to strike in the wee hours during deep sleep, is more common in women than in men.

Differences in diagnosis

When someone shows up at a medical facility with cardiac symptoms, a number of tests can be used to determine the source, beginning with resting electrocardiography (ECG), followed by stress testing, in which a person walks on a treadmill while being monitored by ECG.

However, ECG stress tests are more likely to miss cardiovascular disease in women than in men. Nuclear stress tests, in which an image indicating blood flow to the heart is made before and immediately after exercise, cost more, but they’re more reliable than ECGs in women.

Coronary angiography — an X-ray that outlines blockages in coronary arteries — is considered the gold standard for identifying the location of blockages in people with positive stress tests. But all that glitters isn’t gold for women. Because they’re less likely than men to have discrete, bulging lesions and more likely to experience microvascular disease, their angiograms may show no obstructions. Women may need two additional tests, which can be performed during angiography:

Intravascular ultrasound (IVUS) involves threading a tiny transducer into a coronary artery to capture a cross-sectional image of the artery walls. It can find arteries that have been narrowed more uniformly by atherosclerotic plaque.

Coronary flow reserve studies, in which a catheter measures the change in coronary blood flow in response to increased demand, can indicate whether the microscopic vessels in the heart wall are delivering an adequate blood supply.

Differences in treatment

For women who have uniformly narrowed coronary arteries or microvascular disease, lifestyle changes and medications are the only treatment options. For women and men with obstructive coronary lesions, angioplasty with stenting and coronary bypass surgery are equally likely to succeed in opening their arteries, but women are less likely than men to be offered these procedures.

When women do have bypass surgery or get angioplasty, they tend to be a decade older than men undergoing similar procedures. Perhaps as a result, they require longer hospital stays, have higher death rates in the weeks following the procedure, and are less likely to be referred to coronary rehabilitation centers.

The bottom line

Heart disease is still the No. 1 killer of us all, although death rates have declined by 25% since the late 1990s. Heart disease has become less deadly for a variety of reasons:

better control of risk factors like cholesterol and blood pressure

faster diagnosis,

improvements in emergency care

advances in medications and procedures

If there’s a message for men, it’s that it’s all there for the taking. Diagnostic and therapeutic protocols are made for you. Whether you’ve had a heart attack or are trying to prevent one, your greatest challenge is to adhere to a healthful diet, exercise often, have regular check-ups, and take your medication as prescribed.

The message for women: A healthy lifestyle is key, especially if you have an inflammatory disorder or an expanding waistline. If you’re depressed, get help. And if you feel unusually tired, achy, or short of breath, don’t write it off as nothing — or blame it on aging. Check with your doctor to make sure it isn’t heart disease. If you’re diagnosed with heart disease, you may have to be a little more aggressive in getting the care you need. Seek out one of the women’s heart centers that are springing up in hospitals across the nation.

Pills. (Melanie Tata / Flickr.com / Creative Commons)

GoogleNews.com, February 23, 2010, by Rita Delfiner  —  If you have a rare disease, just hearing how much it costs to treat it could make you sicker, a New York Post report said Tuesday.

The world’s priciest medicine, Soliris, costs an astonishing $409,500 a year for the average patient, a Forbes.com survey of the most expensive medicines on earth revealed.

Most of the pricey pharmaceuticals target rare disorders that affect relatively few people.

Soliris, made by Alexion Pharmaceuticals, is given intravenously to treat paroxysmal nocturnal hemoglobinuria, or PNH, a rare disorder in which the immune system destroys red blood cells. About 8,000 Americans suffer from the disease.

But there is some good news.

Patients do not have to dig that deep to pay for the drugs. Insurance covers most of the costs – and there is help with high co-payments or for those with no insurance.

Alexion spokesman Irving Adler said the high price of Soliris reflects several factors, “including an $800 million investment to develop the drug,” as well as a 15-year investment of time.

The second spot on Forbes’ list is held by Elaprase, which costs about $375,000 a year. The drug, made by Shire Pharmaceuticals, treats Hunter syndrome, an extremely rare metabolic disorder that affects about 500 Americans.

By Jacquelyn K. Beals, PhD

Medscape.com, February 23, 2010 — Hypertension is a “neglected disease,” according to a report released today by the Institute of Medicine. Despite high blood pressure being the cause of death in 1 of 6 US adults, and the greatest single risk factor for deaths from cardiovascular disease, millions of Americans are developing, living with, and dying from hypertension. The decade from 1995 to 2005 saw a 25% increase in the death rate from high blood pressure.

“We are failing to translate our public health and clinical knowledge into effective prevention, treatment, and control programs,” observed the Committee on Public Health Priorities to Reduce and Control Hypertension in the US Population. Their report offers recommendations for changes by individuals, physicians, and policies to prevent and control high blood pressure and associated health problems.

It’s time to add hypertension to the list of neglected diseases, David W. Fleming, MD, chair of the Committee on Public Health Priorities to Reduce and Control Hypertension in the US Population, said during a February 22 briefing at the National Academies’ Keck Center in Washington, DC.

The committee’s recommendations include strengthening collaboration between the Centers for Disease Control and Prevention and related agencies to include hypertension among their lifestyle improvement efforts, monitoring and reducing sodium intake, improving the reporting of hypertension to determine general population and subgroup trends, and improving the quality of care and removing economic barriers to effective antihypertensive treatments.

Down With Sodium, Up With Potassium

The report notes that 87% of adults in the United States ingest more than 2400 mg/day of sodium (1500 mg/day is recommended for individuals middle-aged or older, blacks, or those with hypertension). A strategy recommended to the Division of Heart Disease and Stroke Prevention is the use of potassium/sodium chloride combinations to simultaneously reduce sodium and increase potassium intakes.

Using estimates based on 31 trials of sodium reduction, and data indicating that 87% of the American population consumes excess sodium, the prevalence of hypertension can be expected to decrease 5% to 8% if everyone currently on a high-salt diet decreased their salt intake by about 4.5 g/day.

“Over 8 in 10 Americans eat more salt in their diet than is recommended. And almost everyone consumes too little potassium,” said Dr. Fleming. “The Committee recommends that CDC take a strong and active leadership role working with industry to implement strategies to reduce salt in our diet,…promote the intake of potassium-rich fruits and vegetables, and also consider advocating for the greater use of potassium/sodium salt combinations as a means of simultaneously reducing sodium and increasing potassium intake.”

The effects of potassium supplementation have varied across studies, but data indicate that if the entire population increased its potassium intake to 4700 mg/day, prevalence of hypertension could be reduced as much as 4% to 7%. The proportion of hypertension currently attributed to low potassium intake is around 17%.

High potassium intake can, however, itself be problematic. Lawrence J. Appel, MD, MPH, a member of the American Society of Hypertension and professor of medicine at John Hopkins University, Baltimore, Maryland, who attended the briefing, told Medscape Cardiology, “In general it appears that diets that are both low in sodium and rich in potassium are the best diets in terms of lowering blood pressure [and] controlling hypertension, [but] there are some caveats. There are patients with kidney disease, but it has to be pretty advanced before you get to problems with potassium. And there are patients with advanced heart failure where you’re concerned about it. Typically those are patients that are being cared for and monitored, so…certainly for the general population, but also even for most patients with hypertension who don’t have the problems I mentioned, you’re not going to get any problems from dietary potassium,” Dr. Appel said.

The committee recommends that the Division of Heart Disease and Stroke Prevention and related agencies focus on preventing hypertension by reducing overweight and obesity, increasing physical activity, reducing sodium intake, and increasing intake of fruits, vegetables, and whole grains, especially foods rich in potassium.

Nonadherence as a Clinicians’ Problem

The Division of Heart Disease and Stroke Prevention was also urged to identify better ways of analyzing and reporting data on hypertension over time, establishing norms for data collection analysis and reporting of these data, with a particular focus on children, elderly, minorities, and socioeconomic groups for whom fewer data are available.

Of particular interest were the IOM committee’s findings on patients’ nonadherence to treatment and physicians’ nonadherence to guidelines laid out by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Although the JNC advises starting treatment when systolic blood pressure exceeds 140 mm Hg or diastolic blood pressure exceeds 90 mm Hg, many physicians are much less aggressive. Most cases of uncontrolled hypertension were in older adults with mild systolic hypertension and with frequent contact with their physicians and access to healthcare.

“It was quite striking, actually, that clinicians do a pretty good job of controlling diastolic blood pressure. It’s systolic blood pressure that they’re not aggressively treating, and especially isolated systolic hypertension,” said committee member Corinne Husten, MD, MPH, former executive vice president for Program and Policy, Partnership for Prevention, Washington, DC. “There could be a variety of reasons. When I was in medical school we were taught, ‘You don’t treat a high top number because older people need that head of steam to get the blood through those hardened arteries. And the data since then have shown that’s really not true.”

Dr. Husten noted that clinicians may also be concerned about the adverse effects of medication in older people, and questions about whether full dosage should be used. It will be important to determine the reasons that physicians are not adhering to current guidelines, she said. No data currently address that issue.

Hypertension as a Sentinel for Healthcare Effectiveness

The IOM report also highlighted the financial barriers to lowering blood pressure. Studies have shown that cost of medications to patients is significantly related to patient adherence, especially evident in patients with low income, chronic illness, and multiple prescriptions. The committee recommendation advocates lowering or eliminating costs of antihypertension drugs under Medicare and Medicaid.

At the policy level, recommendations urge state and local public health agencies to emphasize populationwide approaches and to integrate hypertension prevention into programs to influence obesity prevention, increase physical activity, and encourage healthy diets.

On a more positive note, the IOM committee suggested that hypertension can serve as a “sentinel” for program evaluation in public health treatment of a chronic disease and reduction of healthcare disparities. Hypertension has the “advantages” of being objectively diagnosed and measured, low-cost treatments are available, results can be easily measured and reproduced, and the disease responds rapidly to interventions.

“Here is a place where, as a result of new work that has been done, we now not only think we can make a difference, but we have scientific studies in both the public health arena and in the clinical arena that show we can make a difference,” concluded Dr. Fleming.

The full text of the report is available at http://www.nap.edu.

After completion of the Report, Dr. Husten joined the US Food and Drug Administration as senior medical advisor, Center for Tobacco Products (October 2009). Dr. Appel has done clinical research and trials that led to some conclusions of the report and has given invited talks at pharmaceutical companies, but does not feel he has conflicts of interest. One of his National Institutes of Health–sponsored studies received partial support from King-Monarch, which provided medication.

Institute of Medicine. A Population-Based Policy and Systems Change Approach to Prevent and Control Hypertension. Washington, DC: The National Academies Press. February 22, 2010.

MEDICAL NEWS

For physicians, a lost smartphone or forgotten laptop can mean a long, arduous process of notifying patients — and the risk of penalties under HIPAA

  

AMA-ASSN.org, February 23, 2010, by Pamela Lewis Dolan  —  Often the biggest threat to your practice and patient data is not an outside hacker or a snooping employee — it’s somebody’s forgetfulness.

As technology becomes smaller and more portable, it becomes easier to lose. Surveys from a data protection solutions company in 2009 found that in a six-month period, 12,500 mobile devices were left in taxis, and 4,500 USB memory sticks were left in pockets of pants sent to dry cleaners.

Most people — including those in the security business — are not protecting the data on their mobile devices. So if the device is lost, the data could be accessed.

“I’m always surprised at the cowboy attitude,” said Harry Rhodes, director of practice leadership for the American Health Information Management Assn. “You’ve got these people who think, ‘What are the odds of that happening to me?’ And then when it’s happening to you, it’s too late to do anything.”

Just having your phone drop out of your pocket could launch a time-consuming and expensive nightmare of reconstructing data and adhering to fixes mandated under the Health Insurance Portability and Accountability Act.

One-third of health professionals store patient data on laptops, smartphones and USB memory sticks.

 

Provisions in the federal stimulus package have tightened HIPAA notification and enforcement regulations and have made HIPAA violations more costly. For example, the maximum civil penalty from the Dept. of Health and Human Services for a data breach occurring after Feb. 18, 2009, rose from $25,000 to $1.5 million.

So how you do protect yourself from an accidental loss of a device containing sensitive data? Experts recommend two strategies. One is to find a way to handle or store your mobile technology so you can’t lose it easily. The other is to make sure the device has security and encryption features that make it next to impossible to access by anyone who happens to find it.

Paul Stephens, director of policy and advocacy for the Privacy Rights Clearinghouse, said he has seen a recent increase of health information breaches because of the use of mobile devices. Privacy Rights, a San Diego-based consumer advocacy group focused on educating the public on how technology impacts privacy, is developing a database of all known data breaches in the United States to analyze how each breach occurred, Stephens said.

Credant Technologies, a Dallas-based data protection solutions company, noted in a 2008 survey that although more than a third of health care professionals store patient data on laptops, smartphones and USB memory sticks, most do not adequately secure the data.

Sean Glynn, vice president of product marketing at Credant, said the company surveyed smartphone users at a commuter train stop in 2009. When asked if the data on their phones were encrypted, few said yes. When the same survey was conducted among data security professionals at a trade show, the results were nearly identical.

Credant also performed the studies about mobile devices left in taxis and at dry cleaners. Those covered all devices, not just those owned by health care professionals.

Only 39% of health care organizations encrypt data on mobile devices.

 

People “might well protect their traditional desktop or laptop PC, but they are always buying these [portable] devices and bringing them in as their own personal devices,” Glynn said.

Encrypting the data can eliminate the HIPAA obligation to notify patients of a lost device, under a provision that allows an exception if the data cannot be accessed. But in most cases, encryption is not being done.

The Healthcare Information and Management Systems Society, in a survey released in November 2009, found that despite the strengthening of HIPAA regulations, health care organizations have made relatively few changes to their security policies and procedures. For example, only 39% reported using mobile device encryption.

Rhodes likened people’s attitudes towards data security to those of home security systems — no one thinks it’s necessary until something happens.

The Veterans Health Administration, for instance, now requires encryption of all mobile devices and has banned the use of thumb drives after the theft of one from an employee’s home in 2006. Rhodes has seen other organizations block USB ports on desktop computers with a plug-in device or a super glue product, preventing data from being exported onto a thumb or flash drive.

He said there also are software packages that can be downloaded onto PDAs or smartphones that allow the users, in the event the device is lost or stolen, to call a phone number that automatically will erase everything from the device. There also are downloadable GPS systems that can help locate a lost device.

Smartphone and thumb-drive users also should use password protection on the devices, experts said. Use of a password to enter the system is just an additional line of defense that should be coupled with encryption — the most effective means of protection available, they said.

Rhodes said mobile devices often are lost when people are traveling, so simply being more vigilant and aware in places like an airport can help prevent many cases of data loss. For instance, sometimes people set down a laptop bag while flagging a taxi. A thief can run by, grab the bag, then throw it into a waiting car that speeds off. “Always keep the bags on your shoulder,” he said.

Laptops also can disappear from security belts at airports, he said, not necessarily from theft but because many computer cases look alike. Experts suggest attaching a business card to the outside of the case.

Another line of defense is to limit the amount of data on a mobile device.

For example, Stephens of Privacy Rights Clearinghouse said he has seen cases of employees who carry an entire company database around with them. One momentary lapse of good judgment, he said, could become an expensive teaching moment.

 

Additional Information

1 stolen laptop equals lots of missing patient data

A recent case involving one physician, one laptop, two hospitals and 7,000 patients shows how data on the move can risk a security breach.

The case concerned a doctor who transferred to the University of California, San Francisco School of Medicine, from Beth Israel Deaconess Medical Center in Boston. He owned a laptop that still contained data on 2,900 BIDMC patients.

He used that laptop at UCSF, collecting data on another 4,400 patients. The laptop was stolen on Nov. 30, 2009.

The data did not include Social Security numbers or financial information, and there are no indications of unauthorized access. But both hospitals are in the process of sending notices to all patients whose data were on the laptop.

Whether it’s from loss or malicious theft, storing data on mobile devices is the biggest threat to health care information, because the more mobile the data are, the more chances they can get misplaced, experts said. Many health care organizations have banned downloading data onto mobile devices or have blocked or disabled USB ports where devices can be hooked up to transfer data.

Both UCSF and BIDMC said they were reviewing their policies on using mobile devices, including laptops, because of the incident.

GoogleNews.com, Medscape.com, February 23, 2010, by David Douglas – A 23-valent pneumococcal polysaccharide vaccine (PN23) induces enduring antibody responses in middle-aged and elderly people, researchers report in 2 papers in the February 15th Journal of Infectious Diseases.

Dr. Daniel M. Musher, the lead author of one of the papers, reported , “It is important to show that antibody to pneumococcal capsular polysaccharides persists for 5 years and that repeated vaccinations are still associated with a good response.”

He added, “This way, we can infer that, after a few years, protection persists, although at a lower level, than early on. Furthermore, patients are likely, if revaccinated, to respond appropriately.”

Dr. Musher from Merck Research Laboratories, North Wales, Pennsylvania, and colleagues initially studied data on 444 subjects aged 50 to 64 years and 564 aged 65 years or more.

They were further stratified as having had no vaccination prior to the study or having been vaccinated 3 to 5 years before enrollment. In all, 551 subjects were followed for 5 years after vaccination or revaccination.

Baseline antibody levels, while similar in the younger and older groups, were generally 2 to 3 times higher in those who had been vaccinated, and the differences were significant.

Primary vaccination or revaccination induced significant increases in levels of antibody to all 8 serotypes tested (4, 6B, 8, 9V, 12F, 14, 12 and 3).

Antibody levels tended to be slightly lower after revaccination, but the study groups had similar geometric mean concentrations at later time points for 2 to 5 years.

Although levels of antibody to serotype 3 returned to baseline by year 2, at year 5, levels for the other serotypes were similar in both groups and remained significantly higher than levels before primary vaccination.

In the second study, Dr. Susan B. Manoff, also of Merck Research Laboratories, and colleagues studied 120 subjects, all at least 65 years old and therefore at increased risk for pneumococcal disease.

Responses to vaccine serotypes 4, 14, and 23F following primary vaccination with PN23 or revaccination 2 to 5 years later were examined. The results were in keeping with those of the first study.

The researchers reported, “Levels persisted above unvaccinated levels for 5 years. Revaccination was comparable to primary vaccination for inducing elevated and persistent functional and IgG antibody responses.”

Dr Manoff added, “Although a seroprotective threshold has not been established for adults, it is reasonable to project that persons with higher antibody levels would be at less risk for pneumococcal disease than person with lower levels.”

J Infect Dis 2010.