DAILY UPDATE

Report raises safety questions on popular blood thinner

A scientific study suggests the makers of the blood thinner Pradaxa may have held back information that may have prevented serious bleeding complications among some of the million or so Americans using it. Meanwhile, the maker of Pradaxa, German pharmaceutical giant Boehringer Ingelheim, vehemently denied that it held back important safety data.

Boehringer Ingelheim introduced Pradaxa in 2010 as a replacement for the older drug Coumadin, which had been in use for decades. A major selling point was that Pradaxa offered the benefits of stroke prevention without the hassle of frequent blood monitoring needed with Coumadin.

As with any blood thinner, the concern with Pradaxa was the increased risk of bleeding in patients taking it. Major bleeding with Pradaxa at its currently recommended dose occurs in 3.11 percent of patients taking it each year, according to the major trial that led to FDA approval of the drug. The total incidence of bleeding events with use of the drug, including minor and major bleeding, is 16.42 percent per year.

Research on Pradaxa suggests that it carries a lower risk of bleeding into the brain than Coumadin does, along with a lower risk of life-threatening bleeds and minor bleeding. A large Medicare study published in May confirmed prior knowledge that Pradaxa carries a higher risk of major stomach and intestinal bleeding events.

Researchers at the University of Ottawa’s Institute for Safe Medication Practices (ISMP) wanted to find out whether monitoring the levels of Pradaxa in the blood of patients using it would help doctors avoid bleeding complications. To do this, they looked at Boehringer Ingelheim’s own data exploring the impact of blood level monitoring in conjunction with Pradaxa use.

These researchers said the data show that up to 40 percent of all deaths and serious bleeding events related to Pradaxa could have been avoided by simple blood testing. Checking blood levels periodically, they said, might have allowed doctors to lower the dose of Pradaxa or temporarily stop it in patients with dangerously high levels. This in turn might have prevented some bleeding complications. The paper was published in BMJ.

Additionally, the researchers say that Boehringer Ingelheim had this information before Pradaxa was approved in 2010, but that they left it out of the safety information presented to the FDA during the drug’s approval process. Specifically, they said they found internal reports showing that the company’s scientists raised safety concerns about serious bleeding, but that these concerns may have gone unheeded by their superiors

In a statement, Boehringer Ingelheim said that the simulations that served as the basis for these concerns were preliminary and not reliable, and that it would have been inappropriate to report the simulations. They said they did provide the raw data to the FDA.

When asked by ABC News, the FDA declined to comment on the BMJ report. It also did not say how often pharmaceutical companies choose not to report the results of simulations like these to regulators.

This May, Boehringer Ingelheim reached a settlement worth $650 million with about 4,000 people related to alleged bleeding problems with Pradaxa.  In a statement released in connection with the settlement, Boehringer Ingelheim’s counsel said the company stands behind that drug and believes the claims lacked merit, but decided to settle to avoid protracted litigation. Visit ABC News for the story.

Fist bumping beats germ-spreading handshake, study reports

“Fist bumping” transmits significantly fewer bacteria than either handshaking or high-fiving, while still addressing the cultural expectation of hand-to-hand contact between patients and clinicians, according to a study published in the August issue of the American Journal of Infection Control, the publication of the Association for Professionals in Infection Control and Epidemiology (APIC).

In the study from the Institute of Biological, Environmental, and Rural Sciences at Aberystwyth University in the United Kingdom, researchers performed trials to determine if alternative greetings would transmit fewer germs than the traditional handshake. In this experiment, a greeter immersed a sterile-gloved hand into a container of germs. Once the glove was dry, the greeter exchanged a handshake, fist bump, or high-five with a sterile-gloved recipient. Exchanges randomly varied in duration and intensity of contact.

After the exchange, the receiving gloves were immersed in a solution to count the number bacteria transferred during contact. Nearly twice as many bacteria were transferred during a handshake compared to the high-five, and significantly fewer bacteria were transferred during a fist bump than a high-five. In all three forms of greeting, a longer duration of contact and stronger grips were further associated with increased bacterial transmission.

This study expands on the recent call from the Journal of the American Medical Association (JAMA) to ban handshakes from the hospital environment. 

Healthcare providers’ hands can spread potentially harmful germs to patients, leading to healthcare-associated infections (HAIs). HAIs are among the leading causes of preventable harm and death in the United States. The U.S. Centers for Disease Control and Prevention estimates that one in 25 hospitalized patients develops an HAI and 75,000 patients with HAIs die during their hospitalization each year. Visit APIC for the study.

Glaxo files its entry in race for a malaria vaccine

An experimental malaria vaccine GlaxoSmithKline filed with regulators Thursday could help fight one of the world's biggest killers—but rival company Sanaria Inc. has a potentially more effective shot in the works. If Europe's regulators give Glaxo's vaccine—called RTS,S—the green light, it could be in use as soon as 2015, paving the way for a mass vaccination program across sub-Saharan Africa.

That would make RTS,S the world's first vaccine against malaria or any parasitic disease. In clinical trials, RTS,S almost halved malaria cases in children aged 5 months to 17 months, and by around a quarter in young babies. Malaria kills an estimated 600,000 people a year, most of them African children.

Colin Sutherland, head of the department of immunology and infection at the London School of Hygiene and Tropical Medicine, said Glaxo's vaccine could make an important public-health contribution.

While RTS,S is a major advance, it is far from a perfect solution. Its efficacy is lower than had been hoped, and its protection appears to diminish over time. Data released in October showed its effects after 18 months were less than had previously been seen over a year.

Many malaria-vaccine candidates, including a program by Crucell NV, a division of Johnson & Johnson, have been shelved in recent years. RTS,S, which has been supported by the Path Malaria Vaccine Initiative and the Bill and Melinda Gates Foundation, took 30 years to develop. Big drug companies have typically shunned the field as too complex and unprofitable. Glaxo plans to sell RTS,S at just 5% above cost.

Still, there is another player in the race, Rockville, MD-based biotech company Sanaria, founded by Stephen Hoffman, an infectious-disease expert, in his kitchen. Dr. Hoffman worked on an early predecessor of RTS,S and has been testing experimental malaria vaccines on himself since 1987.

Sanaria's vaccine, called PfSPZ, showed impressive results in an early-stage clinical trial involving 57 people last year. PfSPZ demonstrated complete protection against malaria in all six patients that received the highest dose.

Sanaria is now testing the vaccine in larger trials in Mali, Tanzania, Equatorial Guinea, the U.S. and Germany. Dr. Hoffman said he hopes that if all goes well, it could be filed with regulators in 2017.

Unlike RTS,S, which focuses on a single protein of the parasite, PfSPZ uses a version of the whole parasite, made by hand-dissecting mosquitoes. That may confer greater protection.

Critics question the feasibility of PfSPZ's large-scale production and delivery in Africa, since it must be stored in supercold liquid nitrogen. But Dr. Hoffman is confident his team can scale up production if the vaccine is approved, and cites several veterinary vaccines used in Africa that are delivered in similar ways. Visit the Wall Street Journal for the article.

Veterans deal expands medical care, includes $15 billion

Top House and Senate negotiators reached an agreement that includes $15 billion to help ease U.S. military veterans’ long waits for care, according to a summary congressional staffs are providing to veterans’ groups.

The deal expands the type of non-VA hospitals and clinics where veterans could receive care, authorizes leases for 27 new VA facilities, and allows the Department of Veterans Affairs secretary to fire senior executives and create penalties for falsifying data.

The agreement was reached almost two months after VA Secretary Eric Shinseki resigned as an inspector general report showed widespread mismanagement, such as keeping phony lists to hide the long waits veterans face for medical appointments. At least 35 veterans died while awaiting care in Phoenix, according to acting VA Secretary Sloan Gibson.

The deal includes $10 billion in emergency funding to give veterans who can’t get a VA medical appointment the option to receive non-VA care, and $5 billion to pay for hiring staff. It also gives the VA secretary complete authority to immediately fire senior executives, while providing employees with streamlined appeal rights.

The House and Senate passed differing proposals to provide more funding and streamline waiting times, and a conference committee was appointed to come up with a final plan. The measure passed by the House cost $44 billion, while the Senate plan was $35 billion.

Republicans and Democrats involved in the negotiations had said they agreed on most policy changes, though financing remained a sticking point late last week.

The VA has a $160 billion budget and runs the nation’s largest integrated healthcare system. An internal audit in June showed that more than 120,000 veterans hadn’t received a medical appointment or were waiting more than 90 days for care. That number was cut to about 42,400 by July 1, VA data show. Visit Bloomberg for the story.

Total darkness at night is key to success of breast cancer therapy

Exposure to light at night, which shuts off nighttime production of the hormone melatonin, renders breast cancer completely resistant to tamoxifen, a widely used breast cancer drug, says a new study by Tulane University School of Medicine cancer researchers. The study, "Circadian and Melatonin Disruption by Exposure to Light at Night Drives Intrinsic Resistance to Tamoxifen Therapy in Breast Cancer," published in the journal Cancer Research, is the first to show that melatonin is vital to the success of tamoxifen in treating breast cancer.

Principal investigators and co-leaders of Tulane's Circadian Cancer Biology Group, Steven Hill and David Blask, along with team members Robert Dauchy and Shulin Xiang, investigated the role of melatonin on the effectiveness of tamoxifen in combating human breast cancer cells implanted in rats.

"In the first phase of the study, we kept animals in a daily light/dark cycle of 12 hours of light followed by 12 hours of total darkness (melatonin is elevated during the dark phase) for several weeks," says Hill. "In the second study, we exposed them to the same daily light/dark cycle; however, during the 12 hour dark phase, animals were exposed to extremely dim light at night (melatonin levels are suppressed), roughly equivalent to faint light coming under a door."

Melatonin by itself delayed the formation of tumors and significantly slowed their growth but tamoxifen caused a dramatic regression of tumors in animals with either high nighttime levels of melatonin during complete darkness or those receiving melatonin supplementation during dim light at night exposure.

These findings have potentially enormous implications for women being treated with tamoxifen and also regularly exposed to light at night due to sleep problems, working night shifts or exposed to light from computer and TV screens.

"High melatonin levels at night put breast cancer cells to 'sleep' by turning off key growth mechanisms. These cells are vulnerable to tamoxifen. But when the lights are on and melatonin is suppressed, breast cancer cells 'wake up' and ignore tamoxifen," Blask says.

The study could make light at night a new and serious risk factor for developing resistance to tamoxifen and other anticancer drugs and make the use of melatonin in combination with tamoxifen, administered at the optimal time of day or night, standard treatment for breast cancer patients. Visit Tulane for the study.

Agency for Toxic Substances and Disease Registry releases first set of data from National ALS Registry

About 4 in 100,000 people live with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease in the United States, according to the first data summary released by the Agency for Toxic Substances and Disease Registry.

A report in Morbidity and Mortality Weekly Report (MMWR) displays data from the National ALS Registry. This is the only known data that identifies all ALS cases among people living in the United States. Data in the Registry come from two sources: national administrative databases and self-reports from people living with ALS.

The MMWR report’s findings cover the period from Oct. 19, 2010 through Dec. 31, 2011 and include:  A total of 12,187 people were identified with ALS. (Based on 2011 Census data); Overall, ALS was more common among whites, males, non-Hispanics, and persons aged 60–69 years; White men and women were twice as likely to have ALS as black men and women (3.8 per 100,000 compared to 1.9 per 100,000); and Males had a higher rate of ALS than females (across all racial groups).

There is no cure for ALS. The disease causes the nerve cells throughout the body to stop working, leading to paralysis and usually death within two to five years of diagnosis. ALS is not tracked yearly by health officials in the same manner as other diseases and conditions like heart disease and diabetes in the United States with the exception of Massachusetts. Persons with ALS who register via the National ALS Registry can complete brief surveys that may lead to a better understanding of possible risk factors for the disease such as genetics, environmental, and occupational exposures. Visit CDC for more information.

Study links shift work to risk for Type 2 Diabetes

Shift workers, especially men, may be at higher risk for type 2 diabetes compared to people not on such schedules, a new study suggests. Also at special risk are shift workers who don't work on a set schedule, with shifts moving around at various times of the day.

The findings are "not at all surprising," said one expert, Dr. Alan Manevitz, a clinical psychiatrist at Lenox Hill Hospital in New York City. "Physicians have long known that working shifts disrupts many key body chemicals, creating a ripple effect that can lead to ailments such as gastrointestinal disorders, cardiovascular disease and even cancer," he said. "Now type 2 diabetes can be added to this considerable list."

In the new review, researchers analyzed data from 12 international studies involving more than 226,500 people.

The study, led by Zuxun Lu of Huazhong University of Science and Technology in Wuhan, China, took several factors into account, such as workers' shift schedules, their body mass index (BMI, a calculation of height and weight), family history of diabetes and their level of physical activity.

Although the findings weren't able to show a direct cause-and-effect relationship, the researchers found that any amount of shift work was linked to a 9 percent greater risk for developing diabetes. Gender also played a role -- for men engaged in shift work, the risk jumped to 37 percent.

Although the reason why men are at greater risk than women isn't clear, the researchers believe that testosterone levels may play a role. Prior studies have pointed to an association between low testosterone levels and insulin resistance and diabetes, the researchers noted.

Daytime levels of this male hormone are regulated by the internal body clock, Lu's team explained.

Those whose shifts moved around through different periods of the day were especially likely to develop type 2 diabetes than those who worked normal "office hours." The study found rotating shift work to be linked to a 42 percent greater risk for diabetes.

According to Lu's team, erratic working schedules make it more difficult for the body to establish a sleep-wake cycle, and poor sleep may worsen insulin resistance, a precursor to diabetes.

Previous studies have also linked shift work to weight gain and obesity, a big risk factor for type 2 diabetes. And the researchers note that shift work can also affect cholesterol levels and blood pressure.

Another expert said other factors may be at play as well.

"Growth hormone, known to elevate blood glucose when present in excess, peaks at 1 a.m.," noted Dr. Gerald Bernstein, director of the Diabetes Management Program at Friedman Diabetes Institute at the Beth Israel Medical Center in New York City. "Shift work also often makes it more difficult to schedule regular meals and exercise." Still, Bernstein said that "even with a strong risk for diabetes I would not discourage someone from taking a job that is based on shifts." Instead, he said "it would be better to screen shift workers regularly for pre-diabetes and intervene to slow the progression to full-blown diabetes." (HealthDay) Visit NIH for the study.

Palos Community Hospital improves operating room efficiency with RTLS technology

Palos Community Hospital, the major healthcare provider for Chicago's southwest suburbs, is improving efficiency and patient care in its surgery department with Advantages OR, a patient flow system powered by the Real-time Locating System (RTLS) from Versus Technology, Inc.

Surgical suites are dynamic environments where numerous staff and patient interactions must take place before, during and after surgery. If these interactions don't happen in the correct order, or in a timely manner, surgery schedules can be delayed, resulting in longer stays for patients and inefficient use of expensive resources, such as surgeon and OR time.

Palos Community Hospital is overcoming these inherent challenges by improving the flow of patients through surgery using the Versus Advantages OR patient flow system. The solution was added to their existing Versus RTLS in March of 2013.

Both patients and staff wear a Versus Clearview badge to identify their locations using a highly reliable and accurate infrared (IR) and radio frequency (RFID) platform. The location information, along with integrated data from Palos' Meditech EMR, is relayed to Advantages. The technology gives Palos:

·         Real-time visibility of patient locations and status (waiting for anesthesia, in surgery, etc.)

·         Prompts so staff know where to go next (patient ready for surgeon, room ready for turnover, etc.)

·         Passive data collection for historical reporting to help with process improvement initiatives

The Advantages Asset Management system tracks 1,400 IV pumps across 400,000 square feet. The solution helps reduce loss, tracks utilization, and helps ensure each department is properly stocked with ready-to-use pumps.

RTLS also automates Rauland-Borg's Responder 5 nurse call system. When a patient calls the nurse for assistance, the Clearview badge identifies her presence in the room, automatically canceling the call. This allows the nurse to immediately focus on the patient instead of searching for the cancel button. Visit Wall Street Journal for the article.