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DAILY UPDATE

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July 25, 2014   Download print version

Cause sought for gunfight between patient, doctor

HHS says 10.3 million gained health coverage during the Marketplace’s first annual open enrollment period

Heart attacks deadliest for young women, study finds

Who gets saved? Hepatitis cure at $84,000 makes doctors choose

Study finds new cancer risk from hysterectomy device

Middle East Respiratory Syndrome coronavirus detected in the air of a Saudi Arabian camel barn

Psoriatic arthritis patients need better screening, warns panel of experts

Remote-controlled contraceptive microchip implant is the future of medicine

 

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Cause sought for gunfight between patient, doctor

Authorities are attempting to determine why a patient fatally shot a caseworker at a hospital complex in a Philadelphia suburb and whether a psychiatrist who pulled out his own gun and wounded the patient had concerns about him.

The psychiatrist, Dr. Lee Silverman, was grazed in the temple during the gunfight in his office Thursday afternoon with patient Richard Plotts, Delaware County District Attorney Jack Whelan said.

"We do believe that there were some issues between the doctor and the patient, but whether or not he actually feared him is unclear," Whelan said.

The prosecutor identified the caseworker killed at Mercy Fitzgerald Hospital as Theresa Hunt, 53, of Philadelphia. Hunt had accompanied Plotts to an appointment with Silverman at a psychiatric crisis center adjacent to the hospital in Darby, just southwest of Philadelphia, authorities said.

"When the caseworker was shot, (Silverman) crouched down behind the desk to avoid him being shot," Whelan said. "He was able to reach for his weapon, and realizing it was a life or death situation, was able to engage the defendant in the exchange of gunfire."

A struggle ensued and spilled out into the hallway, Whelan said. Another doctor and a caseworker jumped in to help Silverman and secure Plotts' weapon, he said.

The motive for the shooting remained unclear. Whelan said Plotts, of Upper Darby, might have had issues with the doctor over his treatment plan. It is not known, however, if that is why Silverman was armed, apparently against hospital policy.

Whelan said Plotts, 49, underwent surgery Thursday night at the Hospital of the University of Pennsylvania. Silverman was treated and released. Telephone calls to the doctor's home went unanswered.

A spokeswoman for the Mercy Health System said the hospital has a policy barring anyone except on-duty law enforcement officers from carrying weapons on its campus.

But Yeadon Police Chief Donald Molineux said that "without a doubt, I believe the doctor saved lives. Without that firearm, this guy (the patient) could have went out in the hallway and just walked down the offices until he ran out of ammunition," the chief said.

Staff members had heard loud arguing inside Silverman's office during the appointment. They opened the door and noticed the patient had a gun pointed at the doctor, so they quietly closed the door and dialed 911, Whelan said. Gunshots were heard a short time later, just before 2:30 p.m.

Plotts, severely wounded from several shots, emerged from the office, and another doctor and a caseworker helped wrestle him to the floor of the hallway and grabbed his weapon, Whelan said.

The exchange of gunfire occurred on the third floor of the Wellness Center at Mercy Fitzgerald, a 204-bed community teaching hospital. Authorities said there are no surveillance cameras in the doctor's office or the waiting area outside. They also said the center had no metal detectors.

Patients waiting in the first-floor lobby reported a tense scene when police arrived and ordered everyone out. Most of the patients were elderly. Visit ABC News for the story.

 

 

HHS says 10.3 million gained health coverage during the Marketplace’s first annual open enrollment period

Health and Human Services Secretary Sylvia M. Burwell announced the release of a new study, published in the New England Journal of Medicine, estimating that 10.3 million uninsured adults gained healthcare coverage following the first open enrollment period in the Health Insurance Marketplace. The report examines trends in insurance before and after the open enrollment period and finds greater gains among those states that expanded their Medicaid programs under the Affordable Care Act.

According to the authors’ findings, the uninsured rate for adults ages 18 to 64 fell from 21 percent in September 2013 to 16.3 percent in April 2014. After taking into account economic factors and pre-existing trends, this corresponded to a 5.2 percentage-point change, or 10.3 million adults gaining coverage. The decline in the uninsured was significant for all age, race/ethnicity, and gender groups, with the largest changes occurring among Latinos, blacks, and adults ages 18-34 – groups the Administration targeted for outreach during open enrollment.

Coverage gains were concentrated among low-income adults in states expanding Medicaid and among individuals in the income range eligible for Marketplace subsidies. The study finds a 5.1 percentage point reduction in the uninsured rate associated with Medicaid expansion, while in states that have not expanded their Medicaid programs, the change in the uninsured rate among low-income adult populations was not statistically significant.

The study also looks at access to care, and finds that within the first six months of gaining coverage, more adults (approximately 4.4 million) reported having a personal doctor and fewer (approximately 5.3 million) experienced difficulties paying for medical care.

Using survey data from the Gallup-Healthways Well-Being Index for January 1, 2012, through June 30, 2014, the authors analyzed changes in the uninsured rate over time. This is also the first study to associate reductions in the uninsured rate with state-level statistics on enrollment in the Marketplaces and Medicaid under the Affordable Care Act, as described in HHS enrollment reports, and to assess the impact of the improved coverage on access to care. To read the article visit NEJM.

 

 

Heart attacks deadliest for young women, study finds

Heart attacks can be deadliest for young women, according to a new study. Researchers found that not only were young women more likely to be sicker than young men once they arrived at a hospital – they were also more likely to die there.

Yale cardiologist Dr. Harlan Krumholz and colleagues found that anywhere between 2 percent and 3 percent of young women, aged 30-54, who were hospitalized for a heart attack died over the years 2001 to 2010. That compares to 1.7 percent to 2 percent of men the same age, they reported in the Journal of the American College of Cardiology.

“Young women are commonly thought not to be at risk for heart attacks,” Krumholz said. “The point here is that young women should not ignore symptoms that could suggest a heart attack.” The symptoms – which range from chest pain and shortness of breath to fatigue and nausea – can vary between men and women. “While the medical community has focused on educating more women on heart disease, it hasn’t yet customized its message for young women,” says cardiologist Dr. Jennifer Mieres of the North Shore-LIJ Health System. “All of these things lead to a delay in recognizing symptoms, a delayed diagnosis, and a delay in treatment strategies because women are coming in to the hospital later.” Visit NBC for the article.

 

 

Who gets saved? Hepatitis cure at $84,000 makes doctors choose

Early this year, liver specialist Ken Flora and his colleagues sent letters to 1,300 patients announcing exciting news: powerful new drugs to cure the lethal hepatitis C virus were finally available. Soon after, some patients received a different message: notices that their health plans were refusing to pay for the $84,000 drug. So far only about 50 of the patients have received the medicine, Gilead Sciences Inc.’s Sovaldi.

Not since AIDS drug cocktails were introduced almost two decades ago has a medical breakthrough set up such a rush for a life-saving but expensive therapy. Constrained by limited budgets, health insurers and government programs are forced to make hard choices about which patients will get the cure. Many are opting to treat only the sickest.

“No one envisioned this drug would cost so much money, so it has knocked back everyone on their heels,” says Flora, who works at The Oregon Clinic, a group of specialists in the Portland area.

This was supposed to be a good year for hepatitis C sufferers. Finally there’s a reliable cure for a disease that is estimated to kill more people than AIDS in the U.S. each year. Instead, it has been one of dashed expectations and treatment envy.

Medically, it makes sense to treat as many people as possible for the virus, before severe damage has a chance to occur. Trouble is, curing every U.S. patient with Sovaldi and companion drugs could cost $400 billion, assuming some people need to be retreated, according to estimates from hepatitis C researcher Andrea Branch at the Icahn School of Medicine at Mount Sinai in New York. That is more than the $263 billion the U.S. spent on all prescription drugs in 2012, according to government figures.

Sovaldi has been prescribed to 60,000 patients in the U.S., according to a report from Robyn Karnauskas, an analyst at Deutsche Bank AG. Many of them had been on a path to liver transplants, cancer and other serious complications.

Millions more are infected with the virus, and many who have requested the drug are being told they will have to wait.

Health insurers and governments are expected to pay more than $10 billion for Sovaldi in 2014. The treatment often involves another drug, Johnson & Johnson’s Olysio, which analysts estimate will generate $2.2 billion in sales this year.

Sovaldi alone costs $1,000 a pill, or $84,000 for a typical 12-week course, which has made it a flash point in the controversy over the rising price of specialty drugs.

Seventeen tumor medicines introduced since 2009 cost more than $10,000 a month, according to data from Memorial Sloan Kettering Cancer Center. Some specialty medicines can go as high as $600,000 a year. Most expensive drugs, though, are for rare genetic ailments or uncommon tumors, limiting the budget impact. Hepatitis C, by contrast, affects at least 130 million people worldwide.

The debate around Sovaldi’s cost pits patients’ interests against the need to reward pharmaceutical innovation. Gilead, which got the medicine in 2011 with the $11 billion acquisition of Pharmasset Inc., says the pricing is appropriate considering the product’s potential impact.

“It’s not 12 weeks of benefit. It’s a lifetime of benefit. That needs to be taken into account,” Gregg Alton, executive vice president of corporate and medical affairs at the Foster City, California-based drugmaker, said in an interview. “The cure aspect of this has been lost, and the rhetoric just focuses on the $1,000 pill.” The company is treating some uninsured patients for free, though it won’t disclose the exact number of people benefiting from its compassionate use programs. It declined to comment on the cost of manufacturing Sovaldi.

Some economists say paying Sovaldi’s price now will encourage companies to develop breakthroughs in the future.

The Gilead drug was approved in December in the U.S. and can cure the disease in 90 percent of patients, when used in combination with other medicines. Older regimens had a lower success rate and many patients suffered harrowing side effects.

Now Flora has mostly stopped trying to get Sovaldi for those who don’t have liver cirrhosis or other severe complications. He tells patients they should hang tight until new drugs become available that cost less or have better insurance coverage.

There may not be long to wait. AbbVie Inc. could get approval for a new multidrug treatment regimen later this year. Bristol-Myers Squibb Co. has two hepatitis C drugs under review by U.S. regulators and Merck & Co. is in the final stage of tests for a new hepatitis C therapy, containing multiple drugs.

Gilead will make big profits even if only a fraction of eligible patients get Sovaldi. Sales of the drug were $2.27 billion in the first quarter, putting it on target to become one of the best-selling medicines in the world in its first year. Visit Bloomberg for the article.

 

 

Study finds new cancer risk from hysterectomy device

A surgical device commonly used in hysterectomies has the potential to spread more types of cancer in a woman's body than previously thought, new research released Tuesday shows. The report in the Journal of the American Medical Association also reinforces an earlier government assessment that use of the device, a laparoscopic power morcellator, is risky.

In April, the Food and Drug Administration advised doctors to stop using morcellators for removing fibroids in the uterus. The agency concluded the device could spread previously undetected cancerous tissue inside the body, significantly worsening the patient's odds of survival.

The new study by Columbia University doctors found that 1 in 368 women undergoing hysterectomies have a hidden uterine cancer that is at risk of being spread by a morcellator. Significantly, the research examined the records of a much larger group of women than the FDA did in its main analysis.

Many gynecologists disputed the FDA data and its assessment of the device's danger. The agency held a two-day hearing on the issue earlier this month and is expected to decide this year whether to restrict or even ban use of morcellators.

Doctors not involved in the new study said its findings make clear that the device puts a segment of women at risk.

Morcellators deploy spinning blades to slice uterine fibroids or the uterus itself into fragments that can be removed through tiny laparoscopic incisions. Johnson & Johnson, the largest maker of the tool, suspended sales after the FDA's warning in April.

Using a database of insurance information, the authors of the new study, which was funded by the National Cancer Institute, identified more than 36,000 women treated with the device at 500 U.S. hospitals over seven years. The research found a level of hidden-cancer risk similar to the FDA report.

Beyond that, the researchers found the procedure presents the risk of spreading other types of cancer beyond the uterine sarcomas that had been the focus of concern. The study included all cases of women who were found to have uterine cancer after they underwent morcellation, including endometrial cancer, which is far more common.

Estimates dating to the 1990s suggested that the odds of an undetected uterine cancer were rare—as low as 1 in 10,000 cases. But a few studies back then found the risk as high as about 1 in 500 cases. A recent meta-analysis by the FDA put the risk even higher, at 1 in 352, but that estimate was criticized by many specialists as relying on thin data and not rigorous enough to warrant a crackdown on the device.

Proponents of the surgical tool argue that its benefits—helping doctors perform a less-invasive operation—make it too important to ban. Some gynecologists contend that without morcellators, more women will undergo traditional abdominal hysterectomies, which often result in bigger scars, longer recoveries and more complications.

Opponents call the risk too high for an elective procedure, and note there are alternatives. To that point, the study found that morcellation was performed in only about 16% of the more than 230,000 minimally invasive hysterectomies it looked at. Visit the Wall Street Journal for the report.

 

 

Middle East Respiratory Syndrome coronavirus detected in the air of a Saudi Arabian camel barn

Saudi Arabian researchers have detected genetic fragments of Middle East Respiratory Syndrome coronavirus (MERS-CoV) in the air of a barn holding a camel infected with the virus. The work, published this week in mBio, the online open-access journal of the American Society for Microbiology, indicates that further studies are needed to see if the disease can be transmitted through the air.

MERS, a serious viral respiratory illness caused by the coronavirus, has been identified in 699 people as of June 11, according to the World Health Organization; 209 people have died from the condition. An additional 113 cases occurring between 2012 and 2014 were reported by the Saudi Arabian Ministry of Health on June 3.

For the study, researchers on three consecutive days last November collected three air samples from a camel barn owned by a 43-year-old male MERS patient who lived south of the town of Jeddah, who later died from the condition. Four of the man's nine camels had shown signs of nasal discharge the week before the patient became ill; he had applied a topical medicine in the nose of one of the ill camels seven days before experiencing symptoms.

Using a laboratory technique called reverse transcription polymerase chain reaction (RT-PCR) to detect gene expression, they found that the first air sample, collected on November 7, contained genetic fragments of MERS-CoV. This was the same day that one of the patient's camels tested positive for the disease. The other samples did not test positive for MERS-CoV, suggesting short or intermittent shedding of the virus into the air surrounding the camels, said lead study author Esam Azhar, PhD, head of the Special Infectious Agents Unit at King Fahd Medical Research Center and associate professor of medical virology at King Abdulaziz University in Jeddah.

Additional experiments confirmed the presence of MERS-CoV-specific genetic sequences in the first air sample and found that these fragments were exactly identical to fragments detected in the camel and its sick owner.

"The clear message here is that detection of airborne MERS-CoV molecules, which were 100% identical with the viral genomic sequence detected from a camel actively shedding the virus in the same barn on the same day, warrants further investigations and measures to prevent possible airborne transmission of this deadly virus," Azhar said.

"This study also underscores the importance of obtaining a detailed clinical history with particular emphasis on any animal exposure for any MERS-CoV case, especially because recent reports suggest higher risk of MERS-CoV infections among people working with camels," he added.

Meanwhile, he said, mounting evidence for camel-to-human transmission of MERS-CoV warrants taking precautionary measures: People who care for camels or who work for slaughterhouses should wear face masks, gloves and protective clothing, and wash their hands frequently. It is also important to avoid contact with animals that are sick or have tested positive for MERS-CoV. Those who visit camel barns, farms or markets should wash hands before and after contact with animals. In addition, pasteurization of camel milk and proper cooking of camel meat are strongly recommended. Visit the American Society Microbiology for the study.

 

 

Psoriatic arthritis patients need better screening, warns panel of experts

Leading experts have joined together for the first time to call for better screening of psoriatic arthritis to help millions of people worldwide suffering from the condition. Psoriatic arthritis (PsA) causes painful joint inflammation and can cause irreversible joint damage if left untreated. PsA tends to affect people with the skin condition psoriasis, which causes a red, scaly rash, and affects approximately two percent of people in the UK.

Around one in five go on to develop PsA – usually within ten years of the initial skin problem being diagnosed. Coming together to tackle the gaps in the treatment and diagnosis of psoriatic arthritis, expert rheumatologists, dermatologists and patient representatives from Europe and North America formed the Psoriatic Arthritis Forum, and have now made a series of recommendations to combat the condition.

The recommendations were published the journal Arthritis Care and Research. They included:

·         Developing a screening tool for dermatologists and primary care doctors to identify suspected PsA patients

·         Raising awareness about the progression, health-related quality of life components, and other health issues associated with PsA

·         Improving communication between healthcare providers and patients

Dr. Philip Helliwell, of the School of Medicine at the University of Leeds, a member of the Psoriatic Arthritis Forum, said: "We believe up to 50% of psoriasis patients with psoriatic arthritis are undiagnosed, living with sore, stiff and tender joints, without understanding what is causing this pain. Our review points the way forward for effective screening and treatment, in the hope that detection rates of the condition are improved and patients enjoy a better quality of life."

In addition to better screening, experts have called for improved referrals of patients, as well as an algorithm – a step-by-step procedure for primary care physicians - to be developed to help community physicians on patient evaluation and treatment decisions. Visit here for more information about PsA.

 

 

Remote-controlled contraceptive microchip implant is the future of medicine

By 2018, it may be possible to purchase a contraceptive microchip that you implant under your skin that delivers birth control hormones automatically into your blood stream every day for as long as 16 years. That’s the vision of Microchips, a Massachusetts-based startup formed by MIT researchers who are developing a remote-controlled drug delivery microchip you would implant under your skin near your abdomen (or, if you prefer, your backside region). Without having to go back to a doctor, women would be able to switch birth control hormones on and off at the touch of a button.

That’s a big idea and it’s no wonder it’s attracted the attention of Bill Gates, who is backing the microchip contraceptive through the family planning unit of his Bill and Melinda Gates Foundation. Gates sees the contraceptive chip as not something really intended for the Western world — where, no doubt, plenty of single women might line up to use the device – but for the developing world, where it is more than just a lifestyle choice, it is a form of reproductive justice. According to the Gates Foundation, 120 million women in the world’s poorest societies could benefit from voluntary family planning.

Where things get really interesting is that the same technology could be used to deliver just about any drug, not just birth control hormones. In fact, Microchips calls itself a “programmable drug delivery” company. The first clinical tests of the device delivered hormones to women suffering from osteoporosis. The way the chip works, the hormones are housed inside an impregnable platinum and titanium seal.

A single electrical current triggered by the remote control essentially “melts” the seal, enabling the hormone to flow out. In the future, those modules could be loaded up with all sorts of drugs to regulate the human body.

Of course, there are a number of issues that need to be worked out before these contraceptive microchips that trigger a new round of medical innovation. These microchips need to be implanted under the skin. In a best case scenario, the contraceptive microchip won’t be available on the market until 2018 and clinical trials won’t start until 2016. Visit the Washington Post for the story.