Research in the South Texas Medical Center



Want to Volunteer for a Study or Participate in a Clinical Trial?

To learn more about the studies held in the South Texas Medical Center please see the information provided by St. Luke’s Baptist, the Health Science Center, University Health System in partnership with UT Medicine here:

The South Texas Medical Center does not just treat those that are ill. The institutions located here also research and innovate treatment options. Some of the innovations used here include:

  • - Implanting the first Titanium ribs (CHRISTUS Santa Rosa)
  • - Providing the region the Gamma Knife® and Cyberknife® technologies (Methodist Hospital)
  • - Being the first to offer San Antonio the daVinci Robotic surgery (St. Luke’s Baptist Hospital)

There are over 50 centers or institutes of research in the South Texas Medical Center, many of which are affiliated with the University of Texas Health Science Center at San Antonio.

The University of Texas Health Science Center at San Antonio focuses its research on a variety of topics ranging from general medical, nursing and dental procedures to children’s cancer treatment options. Approximately 500 new studies commence each year including those in conjunction with other South Texas Medical Center Institutions.

A great example of this is the partnership between the University of Texas Health Science Center’s Department of Neurosurgery and The Brain and Stroke Network at the Baptist Health System’s St. Luke’s hospital. Their research is supported by the National Institutes of Health and investigates treatments for stroke.

The Health Science Center has achieved a number of research milestones, including the following:

  • - $228 million research portfolio
  • - $109 million in National Institute of Health funding
  • - Ranked in the top 3% of all institutions worldwide receiving federal funding
  • - Ranked #1 in Texas for funding from the National Institute on Aging
  • - $24.5 billion biomedical industry catalyst for San Antonio

The University Health System is home to the lead Level I Trauma Center for South Texas, and serves 22 South Central Texas counties. The Trauma Research Program at University Hospital focuses on identifying new and innovative ways to improve the care, management and treatment of trauma and critically ill patients. University Health System also is known as a pioneer in the field of transplants thanks to the University Transplant Center.

University Health System has achieved a number of research milestones, including the following:

  • In 1987, University Transplant Center performed the first lung transplant in North America for the treatment of emphysema.
  • In 1987, University Transplant Center performed the first heart/double lung transplant in San Antonio.
  • In 1989, University Transplant Center performed one of the first single lung transplants in the world for pulmonary hypertension.

Neuroscience Articles

  • Extra-depth shoes may help alleviate foot pain for older people

    By Kathryn Doyle

    NEW YORK (Reuters Health) - For adults over age 65 with disabling foot pain, being fitted for off-the-shelf extra-depth footwear reduced pain and improved function, according to a new study.

    This type of footwear is often marketed to people with diabetic foot ailments, for whom Medicare - the U.S. government health insurance program for people over 65 - will cover most of the cost of the shoes.

    The structure and function of the foot changes significantly with age regardless of diabetes status, said lead author Hylton B. Menz of the Lower Extremity and Gait Studies Program in the School of Allied Health at La Trobe University in Melbourne, Australia.

    "With advancing age, there is a general tendency for the foot to exhibit increased soft tissue stiffness, decreased range of motion, decreased strength, and a more pronated posture, and to function in a more pronated position with reduced range of motion and less efficient propulsion when walking," Menz told Reuters Health by email.

    A pronated foot has more weight on the inside edge of the foot, rather than evenly distributed, which can give the appearance of the ankles bending slightly toward each other.

    In addition, many older people wear ill-fitting shoes that don't accommodate the changed shape of their feet, he said.

    He and his coauthors had 120 men and women over age 65 with disabling foot pain answer a Foot Health Status Questionnaire and then divided them into two groups.

    Those in the first group were individually fitted for extra-depth shoes, while those in the second group waited until the end of the study four months later to receive their shoes. Everyone continued to receive regular podiatry care.

    Dr. Comfort, Orthofeet and Apis brand extra-depth shoes like those used in the study are available from online retailers in the U.S. for between $100 and $200 per pair.

    The extra-depth footwear group were more likely to report their foot pain had moderately or markedly improved over the four month period and developed fewer keratotic lesions, like corns or calluses, than the comparison group.

    Corns and calluses are common for older people; treating them accounts for up to 75 percent of a podiatrist's workload, Menz said.

    When the participants took the foot health questionnaire again, the special footwear group scored 11 points better for pain and 10 points better for function than the comparison group, according to the results in the Journal of Gerontology: Medical Sciences.

    Patients considered that a worthwhile improvement, Menz said. And, surprisingly, it didn't matter what the underlying cause of the foot pain was: extra-depth shoes seemed to help everyone who wore them.

    "Many older people wear ill-fitting shoes, and we know that ill-fitting shoes are associated with foot problems," he said.

    Regular footwear is generally too shallow and narrow to accommodate bunions, hammertoes and clawtoes, so the friction that develops within the shoe leads to pain and reduced function, he said.

    "Well-fitting footwear will prevent shoes pressing or rubbing against the sensitive areas of the foot including joints that have become arthritic," said Professor Wesley Vernon, head of Podiatry Services and Research Lead at Jordanthorpe Health Centre in Sheffield, UK, who was not part of the new study.

    Many patients may be reluctant to switch to "medical" footwear because of its appearance, the experts noted.

    "Some research has shown that people, particularly women, don't like the look of this extra deep and extra wide footwear and this is not age dependent," said Anita Williams, senior lecturer in the School of Health Sciences at the University of Salford in the UK.

    In her experience, many women prefer to wear pumps, she told Reuters Health by email.

    Aside from trying new shoes, maintaining a healthy body mass index may help alleviate or prevent foot pain, Menz said.

    "It is also important that older people with foot pain consult a podiatrist, particularly if they have diabetes or changing footwear does not alleviate symptoms," he said.

    SOURCE: http://bit.ly/1mUS1CV Journal of Gerontology: Medical Sciences, online September 9, 2014.

  • Cell transplant helps paralyzed man walk with frame

    By Kate Kelland

    LONDON (Reuters) - A Polish man who was paralyzed from the chest down in a knife attack can now walk with the aid of a frame after receiving pioneering transplant treatment using cells from his nose.

    The technique, described as a breakthrough by a study in the journal Cell Transplantation, involved transplanting what are known as olfactory ensheathing cells into the patient's spinal cord and constructing a "nerve bridge" between two stumps of the damaged spinal column.

    "We believe... this procedure is the breakthrough which, as it is further developed, will result in a historic change in the currently hopeless outlook for people disabled by spinal cord injury," said Geoffrey Raisman, a professor at University College London's (UCL) institute of neurology, who led the research.

    The 38-year-old patient, Darek Fidyka, was paralyzed after suffering stab wounds to his back in 2010. Following 19 months of treatment, he has recovered some voluntary movement and some sensation in his legs, his medics said.

    The Nicholls Spinal Injury Foundation, a British-based charity which part-funded the research, said in statement that Fidyka was continuing to improve more than predicted, and was now able to drive and live more independently.

    Raisman, a UCL spinal injury specialist, worked with surgeons at Wroclaw University Hospital in Poland to remove one of Fidyka's olfactory bulbs, which give people their sense of smell, and transplant his olfactory ensheathing cells (OECs) and olfactory nerve fibroblasts (ONFs) into the damaged area.

    They used a nerve bridge constructed between the two stumps of the damage spinal column, they said in the study.

    OECs are a type of cell found in both the peripheral and central nervous system. Together with ONFs, they make bundles of nerve fiberes that run from the nasal mucosa to the olfactory bulb, where the sense of smell is located.

    When the nerve fibers that carry smell become damaged, they are replaced by new nerve fibers that re-enter the olfactory bulbs, the researchers explained in their study.

    OECs help this process by re-opening the surface of the bulbs for the new nerve fibers to enter - leading Raisman and his team to believe transplanting OECs into the damaged spinal cord could enable severed nerve fibers to re-grow.

    Raisman added that the technique of bridging the spinal cord with nerve grafts from the patient had been used in animal studies for years, but never before in combination with OECs.

    "The OECs and the ONFs appeared to work together, but the mechanism between their interaction is still unclear," he said in a statement about the work.

    Experts not directly involved in the work said its results offered some new hope, but said more work needed to be done to figure out what had led to this success, and more patients treated, before its potential could be properly assessed.

    "While this study is only in one patient, it provides hope of a possible treatment for restoration of some function in individuals with complete spinal cord injury," said John Sladek, a professor of neurology and pediatrics at the University of Colorado School of Medicine in the United States.

    Raisman and his team now plan to repeat the treatment technique in between three and five patients over the next three to five years. "This will enable a gradual optimization of the procedures," he told Reuters.

    SOURCE: http://bit.ly/ZMtGV6 Cell Transplantation, online October 21, 2014.

  • Parkinson's drugs linked to impulse control disorders

    By Kathryn Doyle

    NEW YORK (Reuters Health) - Drugs for Parkinson's disease can sometimes cause patients to have difficulty controlling their impulses, researchers say.

    The medicines, known as dopamine receptor agonist drugs, were linked with higher risks for pathological gambling, hypersexuality and compulsive shopping in a new study.

    Cases of these severe impulse control disorders linked to the drugs have been reported for more than 10 years, and in many cases the abnormal behavior stops when patients stop taking the medications, lead author Thomas J. Moore of the Institute for Safe Medication Practices in Alexandria, Virginia, and colleagues write in their report of the study.

    The Parkinson's Disease Foundation says on its website that in one earlier study, dopamine agonists were linked with compulsive behaviors in up to 14 percent of patients.

    To further investigate the connection, Moore's team analyzed 2.7 million serious drug side effects reported in the FDA Adverse Event Reporting System between 2003 and 2012 in the U.S. and 21 other countries. They identified 1,580 impulse control disorder events, 710 linked to dopamine agonist drugs and 870 associated with other drugs.

    The dopamine agonists were most often prescribed for Parkinson's disease but were also sometimes prescribed for patients with restless leg syndrome.

    Dopamine agonist drugs were 277 times more likely to result in a report of specific impulse control symptoms than other drugs, Moore told Reuters Health by email.

    "This tells you that reports associating a drug with pathological gambling or hypersexuality are extremely rare, except for this group of drugs," he said.

    That's a large increase in risk, and the actual risk could in fact be higher, since these data rely on official reports of drug side effects, according to Joshua J. Gagne of Brigham and Women's Hospital and Harvard Medical School in Boston.

    Gagne wrote an editorial accompanying the new results.

    There was also a link between impulse control disorders and antidepressants or antipsychotics, but not as powerful as the link with the Parkinson's drugs.

    One characteristic of Parkinson's disease is a reduction in the amount of the neurotransmitter dopamine in the brain. Dopamine agonist drugs, which include pramipexole (Mirapex), ropinirole, cabergoline, bromocriptine (Cycloset), rotigotine and apomorphine (Apokyn) in the U.S., activate dopamine receptors even in the absence of dopamine itself.

    Usually, when a drug can have a serious side effect, the manufacturer is required by the U.S. Food and Drug Administration to put a warning about the problem in the drug's packaging, in a bold black box that makes the warning easy to see.

    None of these six drugs come with so-called Boxed Warnings about the potential behavioral side effects, but all six should come with clear and prominent warnings, the authors write.

    Dopamine plays a complex role in regulating behavior, Gagne said, and drugs that affect the way the brain uses dopamine may reduce the threshold for impulsive behaviors.

    "More and more we are learning what it does," he said. "It makes biological sense that this may be causal."

    These compelling results are some of the best evidence we may be able to get concerning the behavioral consequences of dopamine agonist drugs, Gagne said. It's difficult to study because many patients may not want to disclose their gambling or sexual behavior problems, he said.

    "I think that this is one more piece of the puzzle that there may be something going on here with these drugs," Gagne told Reuters Health by phone.

    Patients need not be concerned, but if they find all of a sudden that they have a gambling problem, they should have a frank discussion about that with their doctor, he said.

    "Doctors should understand and weigh these risks against the benefits," Moore said. "There is a lot of difference between a patient with advanced Parkinson's disease with severely impaired motor control and a patient with a mild case of restless leg syndrome."

    SOURCE: http://bit.ly/IZGqPC JAMA Internal Medicine, October 20, 2014.

  • Soccer-Indian footballer dies after fatal goal celebration

    By Amlan Chakraborty

    NEW DELHI (Reuters) - A 23-year-old Indian footballer has died from severe spinal cord damage after attempting to celebrate a goal with a somersault, an official told Reuters on Monday.

    Bethlehem Vengthlang FC midfielder Peter Biaksangzuala died on Sunday at a hospital in the northeastern Indian state of Mizoram after the incident in Tuesday's match in the third tier Mizoram Premier League (MPL).

    "We are shocked by the case. We at the Mizoram Football Association did all we could but could not save him," MFA secretary Lalnghinglova Hmar told Reuters by telephone.

    After scoring the equalizer against Chanmari West FC, a flipping Biaksangzuala landed awkwardly and was lying unconscious as his team mates surrounded him and gestured for help.

    "We considered the option to fly him to Delhi but his condition was pretty bad. He was mostly unconscious, occasionally spelling out a few words," Hmar said.

    Bethlehem has decided to retire the number 21 jersey as a tribute to Biaksangzuala while Hmar said MFA would organize a match in his memory.

    FIFA said that any additional measures curbing goal celebrations would have to be approved by soccer's rule-making body, the International Football Association Board (IFAB).

    "This is a tragedy and we are very concerned about this incident," said FIFA in a statement to Reuters.

    "It is the responsibility of IFAB to rule on amendments to the Laws of the Game."

    FIFA added that any national association can propose a change to the rules, and the suggestion must be submitted by Dec. 1 to be considered at IFAB's next annual general meeting.

    The laws of the game currently stipulate automatic yellow cards if a player removes his shirt, covers his face with a mask, makes a provocative gesture or climbs a perimeter fence to celebrate a goal.

    The laws also state: "While it is permissible for a player to demonstrate his joy when a goal has been scored, the celebration must not be excessive.

    "Reasonable celebrations are allowed, but the practice of choreographed celebrations is not to be encouraged when it results in excessive time-wasting and referees are instructed to intervene in such cases.

    "Referees are expected to act in a preventative manner and to exercise common sense in dealing with the celebration of a goal."

    Last month, a player in Brazil escaped injury when he leapt into a hole as another goal celebration went wrong.

    Coritiba forward Joel leapt the advertising hoardings behind the goal, unaware that there was a hole with steps leading down from the pitch to the dressing rooms.

    Although he landed in the hole, his fall was softened by a tarpaulin and he was able to continue the match.

  • Third death attributed to ecstasy reported after Dutch dance festival

    By Reuters Staff

    AMSTERDAM (Reuters) - A 41-year-old Dutch woman died after attending a weekend dance festival, police said on Monday, increasing to three the number of deaths at the popular Amsterdam Dance Event suspected of being caused by the drug ecstasy.

    A police department tweet said the woman died after drug use. The police have also issued a warning about tainted drugs.

    The woman and two men, aged 21 and 33, are believed to have gotten sick after taking the party drug, but autopsies have yet to confirm the cause of death.

    A police statement said the woman from the central Dutch city of Utrecht died Sunday morning after going to see DJs perform at the festival, during which hundreds of clubs host electronic music shows.

    Drug deaths are fairly rare in the Netherlands, where use of recreational drugs is tolerated by authorities and party-goers can have drugs tested for free by health authorities.

Oncology Articles

  • REFILE-Giving pricey hepatitis drug to prisoners may be financially wise

    (Revises para 23 to clarify quote.)

    By Andrew M. Seaman

    NEW YORK (Reuters Health) - When prisoners have hepatitis C, treating them with expensive new antiviral drugs makes fiscal sense despite the hefty pricetag, according to a new study.

    Based on computer models, new pricey drug combinations that treat hepatitis C infections were more cost-effective than older drug combinations and no treatment at all, researchers found.

    "Essentially what our model does is follow a hypothetical cohort of prisoners that looks like a prison population in the U.S.," Jeremy Goldhaber-Fiebert told Reuters Health.

    "It allows us to ask a variety of 'what-if' questions and probe how sensitive our findings are to various factors," said Goldhaber-Fiebert, the study's senior author from Stanford University in California.

    Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. (Most commonly, this happens when people share needles, syringes, or other equipment to inject drugs - but before 1992 hepatitis C was also transmitted by blood transfusions.)

    When people are first infected, the symptoms can include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

    If left untreated, hepatitis C can slowly, over years or decades, lead to liver damage, liver failure, liver cancer, and a need for liver transplant, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

    The CDC says about 3.2 million people in the U.S. are infected with the chronic disease. Goldhaber-Fiebert and his colleagues write in Annals of Internal Medicine that about 500,000 incarcerated people have hepatitis C.

    Until recently, the virus was treated with a combination of drugs that had to be taken for about a year and caused people to have flu-like symptoms. The treatment was only effective in a minority of patients.

    The U.S. Food and Drug Administration (FDA) approved Merck's Victrelis, which is known generically as boceprevir, in 2011 to be added to the existing combination of drugs. The new combination made the treatment more effective - and more expensive (see Reuters story of May 13, 2011 here: http://reut.rs/1yg9GGm).

    Then, the FDA approved Gilead's Sovaldi, which is known generically as sofosbuvir, in 2013. The drug is taken for 12 weeks and cures a majority of patients but comes with a price tag of $84,000 (see Reuters story of December 6, 2013 here: http://reut.rs/1ygcAuT).

    Insurers have pushed back against the price of the new medication (see Reuters story of May 20, 2014 here: http://reut.rs/1ygfGPx).

    To examine benefits and costs associated with hepatitis C treatment among the U.S. prison population, the researchers used a computer model. They compared prisoners who received 12 weeks of Sovaldi plus the original drug combination, prisoners who received 28 weeks of Victrelis plus the original drug combination and prisoners who did not receive treatment.

    They examined costs of treatment in terms of quality-adjusted life years (QALY), which is the amount of time in good health that inmates could gain from the treatment.

    Overall, they found the combination of Sovaldi and the original drugs added 2.1 QALYs at a cost of about $54,000, compared to no treatment.

    The combination including Sovaldi cost about $25,700 per QALY gained among prisoners serving short sentences and about $28,800 per QALY gained among those serving long sentences. The difference in cost can be partially attributed to various factors, including the increased risk of reinfection among people still in prison, Goldhaber-Fiebert said.

    In either case, he and his colleagues found Sovaldi combination of drugs to be less expensive per QALY than the Victrelis combination.

    However, there are other challenges when choosing a hepatitis C treatment for prisoners, the researchers write.

    For example, treating U.S. prisoners infected with hepatitis C with the Sovaldi combination may come at an upfront cost exceeding $30 billion to the prison systems. The cost benefits may not be realized until the prisoners are released on another healthcare system like Medicaid, which is government-run insurance for the poor.

    "Most people in will be out," said Dr. Anne Spaulding. "We're looking at a disease that will take 30 years to progress. A lot of hepatitis C that we're not treating in the prison will end up being very costly not just for patients who are on Medicaid, but patients who do not have Medicaid who present to emergency rooms. Someone will have to pay."

    Spaulding, who wasn't involved with the new study, is an expert on hepatitis C infections among U.S. prisoners. She's an assistant professor at Emory University's Rollins School of Public Health in Atlanta.

    The U.S. Federal Bureau of Prisons currently recommends Sovaldi for many prisoners with hepatitis C infections.

    "I think the key message would be to those who control state budgets," said Spaulding. "There are benefits to considering the health of people returning to the community. There are benefits to treating hepatitis C while they're incarcerated."

    "The group that can have the most affect on increasing the new infections of hepatitis C is actually the injection drug users," she said. "If you can get rid of the hepatitis C while they're in prison, they can't spread hepatitis C when they're in the community."

    "It's a message that needs to go to the decision makers who control the purse strings," she said, adding that this is especially true for people who control state budgets.

    Goldhaber-Fiebert said prisons and jails in the U.S. should give careful consideration to the hepatitis C treatment for the population that they provide services to.

    "High-cost treatments can also be high-value if they deliver substantial enough value," he said.

    SOURCE: http://bit.ly/1zjAkCK Annals of Internal Medicine, online October 20, 2014.

  • REFILE-Giving pricey hepatitis drug to prisoners may be financially wise

    (Revises para 23 to clarify quote.)

    By Andrew M. Seaman

    NEW YORK (Reuters Health) - When prisoners have hepatitis C, treating them with expensive new antiviral drugs makes fiscal sense despite the hefty pricetag, according to a new study.

    Based on computer models, new pricey drug combinations that treat hepatitis C infections were more cost-effective than older drug combinations and no treatment at all, researchers found.

    "Essentially what our model does is follow a hypothetical cohort of prisoners that looks like a prison population in the U.S.," Jeremy Goldhaber-Fiebert told Reuters Health.

    "It allows us to ask a variety of 'what-if' questions and probe how sensitive our findings are to various factors," said Goldhaber-Fiebert, the study's senior author from Stanford University in California.

    Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. (Most commonly, this happens when people share needles, syringes, or other equipment to inject drugs - but before 1992 hepatitis C was also transmitted by blood transfusions.)

    When people are first infected, the symptoms can include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

    If left untreated, hepatitis C can slowly, over years or decades, lead to liver damage, liver failure, liver cancer, and a need for liver transplant, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

    The CDC says about 3.2 million people in the U.S. are infected with the chronic disease. Goldhaber-Fiebert and his colleagues write in Annals of Internal Medicine that about 500,000 incarcerated people have hepatitis C.

    Until recently, the virus was treated with a combination of drugs that had to be taken for about a year and caused people to have flu-like symptoms. The treatment was only effective in a minority of patients.

    The U.S. Food and Drug Administration (FDA) approved Merck's Victrelis, which is known generically as boceprevir, in 2011 to be added to the existing combination of drugs. The new combination made the treatment more effective - and more expensive (see Reuters story of May 13, 2011 here: http://reut.rs/1yg9GGm).

    Then, the FDA approved Gilead's Sovaldi, which is known generically as sofosbuvir, in 2013. The drug is taken for 12 weeks and cures a majority of patients but comes with a price tag of $84,000 (see Reuters story of December 6, 2013 here: http://reut.rs/1ygcAuT).

    Insurers have pushed back against the price of the new medication (see Reuters story of May 20, 2014 here: http://reut.rs/1ygfGPx).

    To examine benefits and costs associated with hepatitis C treatment among the U.S. prison population, the researchers used a computer model. They compared prisoners who received 12 weeks of Sovaldi plus the original drug combination, prisoners who received 28 weeks of Victrelis plus the original drug combination and prisoners who did not receive treatment.

    They examined costs of treatment in terms of quality-adjusted life years (QALY), which is the amount of time in good health that inmates could gain from the treatment.

    Overall, they found the combination of Sovaldi and the original drugs added 2.1 QALYs at a cost of about $54,000, compared to no treatment.

    The combination including Sovaldi cost about $25,700 per QALY gained among prisoners serving short sentences and about $28,800 per QALY gained among those serving long sentences. The difference in cost can be partially attributed to various factors, including the increased risk of reinfection among people still in prison, Goldhaber-Fiebert said.

    In either case, he and his colleagues found Sovaldi combination of drugs to be less expensive per QALY than the Victrelis combination.

    However, there are other challenges when choosing a hepatitis C treatment for prisoners, the researchers write.

    For example, treating U.S. prisoners infected with hepatitis C with the Sovaldi combination may come at an upfront cost exceeding $30 billion to the prison systems. The cost benefits may not be realized until the prisoners are released on another healthcare system like Medicaid, which is government-run insurance for the poor.

    "Most people in will be out," said Dr. Anne Spaulding. "We're looking at a disease that will take 30 years to progress. A lot of hepatitis C that we're not treating in the prison will end up being very costly not just for patients who are on Medicaid, but patients who do not have Medicaid who present to emergency rooms. Someone will have to pay."

    Spaulding, who wasn't involved with the new study, is an expert on hepatitis C infections among U.S. prisoners. She's an assistant professor at Emory University's Rollins School of Public Health in Atlanta.

    The U.S. Federal Bureau of Prisons currently recommends Sovaldi for many prisoners with hepatitis C infections.

    "I think the key message would be to those who control state budgets," said Spaulding. "There are benefits to considering the health of people returning to the community. There are benefits to treating hepatitis C while they're incarcerated."

    "The group that can have the most affect on increasing the new infections of hepatitis C is actually the injection drug users," she said. "If you can get rid of the hepatitis C while they're in prison, they can't spread hepatitis C when they're in the community."

    "It's a message that needs to go to the decision makers who control the purse strings," she said, adding that this is especially true for people who control state budgets.

    Goldhaber-Fiebert said prisons and jails in the U.S. should give careful consideration to the hepatitis C treatment for the population that they provide services to.

    "High-cost treatments can also be high-value if they deliver substantial enough value," he said.

    SOURCE: http://bit.ly/1zjAkCK Annals of Internal Medicine, online October 20, 2014.

  • Petition calls on Roche to cut breast cancer drug price

    By Reuters Staff

    LONDON (Reuters) - A British-led petition signed by 29,000 people has demanded that Switzerland's Roche, the world's biggest maker of cancer medicines, cut the price of its expensive new breast cancer drug Kadcyla.

    The campaign shows the growing pressure on drug companies as a raft of promising new cancer treatments reach the market. U.S. insurers also say they are alarmed by a coming flood of cancer medicines with "astronomical price tags," while pricing rows have flared in France and Italy.

    Kadcyla can add about half a year to the lives of some women with inoperable breast cancer but Britain's cost watchdog NICE estimates it costs about 90,000 pounds ($145,000) per patient and is too pricey for the state-run health service.

    Roche argues the cost reflects the benefits offered by its innovative treatment. It also disputes the headline price cited by the National Institute for Health and Care Excellence (NICE).

    NICE bases its calculation on a mean treatment course of 14.5 months, whereas the median length of treatment in clinical trials -- the measure Roche believes is more relevant -- was 9.6 months, reducing the cost per patient significantly.

    The Care2 petition, calling on Roche Chief Executive Severin Schwan to reduce the price of Kadcyla to a level public health services can afford, was started by British breast cancer survivor Margaret Connolly.

    Kadcyla combines the antibody used in Roche's established Herceptin drug and a tumor-killing payload that is delivered directly into cancer cells, causing fewer chemotherapy-related side effects such as hair loss.

    It is one of a number of targeted therapies that are revolutionizing cancer care. Other promising new approaches include a range of drugs to help the immune system fight cancer, which also carry a high price.

  • TV adaptation of Ebola best-seller 'The Hot Zone' in the works

    By Reuters Staff

    LOS ANGELES (Reuters) - Fox's television studio has been developing an adaptation of the best-selling 1994 Ebola chronicle "The Hot Zone" for more than a year, the Twenty-First Century Fox Inc-owned company said on Friday.

    "It's a strange and upsetting coincidence that we all happen to be experiencing this current scare, and we're of course extremely sensitive about it," Executive Producer Lynda Obst, who is developing the project with Fox TV Studios and "Alien" director Ridley Scott's Scott Free Productions, said in a statement.

    "While we are far from a finished product that, regardless, would never air during this current news cycle, I do think Preston's take is illuminating, particularly with some distance," Obst said.

    If the adaptation of Richard Preston's non-fiction thriller about viral hemorrhagic fevers such as Ebola makes it into production, it will likely be as a limited-run series, Fox TV Studios said. The book describes the discovery of a virus related to Ebola in a primate quarantine facility in Reston, Virginia in 1989.

    The current Ebola outbreak has killed more than 4,500 people since March, mostly in the three impoverished West African countries of Guinea, Liberia and Sierra Leone, according to the World Health Organization.

    Fears that the outbreak would spread outside of that region have grown since a nurse in Spain became infected, a Liberian man died Oct. 8 in Dallas, Texas and two of the nurses who treated him were also diagnosed with the illness.

    A series developed by Fox's TV studio also does not guarantee that it would be broadcast on one of its parent company's networks in the United States as it could be sold to another network. Preston's book has become one of the best-selling books on online retailer Amazon two decades after its initial release.

  • Diet may influence ovarian cancer survival

    By Kathryn Doyle

    NEW YORK (Reuters Health) - Women with healthier diets before an ovarian cancer diagnosis are less likely to die in the years following the cancer than women with poorer diets, according to a new study.

    The exceptions were women with diabetes or a high waist circumference, which is often linked to diabetes.

    A healthy diet before diagnosis may indicate a stronger immune system and, indirectly, the capacity to respond favorably to cancer therapy, said lead author Cynthia A. Thomson of Health Promotion Sciences at the Canyon Ranch Center for Prevention and Health Promotion at the University of Arizona in Tucson.

    "It also may reflect our capacity to sustain healthy eating after diagnosis, which in turn could support better health in a broader sense," Thomson told Reuters Health by email.

    Researchers looked back at 636 cases of ovarian cancer occurring between 1993 and 1998, 90 percent of which were invasive cancers.

    The women had filled out dietary and physical activity questionnaires at least one year before their cancer diagnoses as part of the larger Women's Health Initiative study. Researchers measured their heights, weights and waist circumferences.

    The healthy eating index in this study measured 10 dietary components, scoring diets with a higher amount of vegetables and fruit, more variety in vegetables and fruit, more whole grains, lower amounts of fat and alcohol and more fiber as healthier than other diets.

    On average, the women were diagnosed with ovarian cancer around age 63.

    As of September 17, 2012, 354 of the women had died, and 305 of those died specifically from ovarian cancer.

    When the researchers divided the women into three groups based on their diet quality, those in the healthiest-eating group were 27 percent less likely to die of any cause after ovarian cancer diagnosis than those in the poorest diet group, according to the results published in JNCI, the Journal of the National Cancer Institute.

    There was a similar but slightly weaker association between pre-diagnosis diet and death due specifically to ovarian cancer.

    "The index gives more points for eating good foods, such as vegetables and whole grains, and fewer points for eating not-recommended foods, such as added sugars, fatty foods and refined grains," said Dr. Elisa V. Bandera, associate professor of Epidemiology at Rutgers Cancer Institute of New Jersey in New Brunswick.

    "Interestingly, they found that it was not the individual components that affected mortality, but an overall healthy diet," said Bandera, who was not part of the new study.

    A diet rich in fruits, vegetables and whole grains may lower inflammation, which has been linked to ovarian cancer mortality, she told Reuters Heath by email.

    "Such a diet has also been linked to reduced risk of other chronic diseases such as diabetes and cardiovascular disease which may complicate ovarian cancer treatment and increase mortality," she said.

    High scores on the Healthy Eating Index are very similar to guidelines and recommendations for cancer survivors provided by the American Institute for Cancer Research and the American Cancer Society, Dr. Anne McTiernan of the Fred Hutchinson Cancer Research Center in Seattle told Reuters Health by email.

    "However, the data on diet and lifestyle associations with ovarian cancer survival are all observational," said McTiernan, who was not involved in the new study. "Clear recommendations would require a randomized controlled clinical trial - the gold standard of medical evidence - before women with ovarian cancer could be advised to change their lifestyles in order to improve their prognosis."

    Women with a history of diabetes and those with a waist circumference greater than 34 inches did not seem to get the same survival benefit from a healthy diet as other women. In their report, the study authors note that past research has already linked diabetes with higher-than-average mortality in ovarian cancer.

    The amount of regular exercise women got before diagnosis did not seem to affect the link between diet quality and survival.

    Although the researchers accounted for exercise and total calorie intake, they did not account for ovarian cancer treatment. Women who had healthier diets may also have had access to better treatment, Bandera noted.

    In any case, Thomson said, healthy diets do seem to be important to reduce cancer risk and to improve survival after cancer. "One in two U.S. adults will be diagnosed with some form of cancer in their lifetime and eating healthy is important in regards to how we come through this experience."

    Healthy behaviors may also delay the onset of cancer, for example from age 55 to 65, but that is difficult to demonstrate, she said.

    SOURCE: http://bit.ly/VFCL0c JNCI, online October 16, 2014.

Orthopedic Articles

  • Extra-depth shoes may help alleviate foot pain for older people

    By Kathryn Doyle

    NEW YORK (Reuters Health) - For adults over age 65 with disabling foot pain, being fitted for off-the-shelf extra-depth footwear reduced pain and improved function, according to a new study.

    This type of footwear is often marketed to people with diabetic foot ailments, for whom Medicare - the U.S. government health insurance program for people over 65 - will cover most of the cost of the shoes.

    The structure and function of the foot changes significantly with age regardless of diabetes status, said lead author Hylton B. Menz of the Lower Extremity and Gait Studies Program in the School of Allied Health at La Trobe University in Melbourne, Australia.

    "With advancing age, there is a general tendency for the foot to exhibit increased soft tissue stiffness, decreased range of motion, decreased strength, and a more pronated posture, and to function in a more pronated position with reduced range of motion and less efficient propulsion when walking," Menz told Reuters Health by email.

    A pronated foot has more weight on the inside edge of the foot, rather than evenly distributed, which can give the appearance of the ankles bending slightly toward each other.

    In addition, many older people wear ill-fitting shoes that don't accommodate the changed shape of their feet, he said.

    He and his coauthors had 120 men and women over age 65 with disabling foot pain answer a Foot Health Status Questionnaire and then divided them into two groups.

    Those in the first group were individually fitted for extra-depth shoes, while those in the second group waited until the end of the study four months later to receive their shoes. Everyone continued to receive regular podiatry care.

    Dr. Comfort, Orthofeet and Apis brand extra-depth shoes like those used in the study are available from online retailers in the U.S. for between $100 and $200 per pair.

    The extra-depth footwear group were more likely to report their foot pain had moderately or markedly improved over the four month period and developed fewer keratotic lesions, like corns or calluses, than the comparison group.

    Corns and calluses are common for older people; treating them accounts for up to 75 percent of a podiatrist's workload, Menz said.

    When the participants took the foot health questionnaire again, the special footwear group scored 11 points better for pain and 10 points better for function than the comparison group, according to the results in the Journal of Gerontology: Medical Sciences.

    Patients considered that a worthwhile improvement, Menz said. And, surprisingly, it didn't matter what the underlying cause of the foot pain was: extra-depth shoes seemed to help everyone who wore them.

    "Many older people wear ill-fitting shoes, and we know that ill-fitting shoes are associated with foot problems," he said.

    Regular footwear is generally too shallow and narrow to accommodate bunions, hammertoes and clawtoes, so the friction that develops within the shoe leads to pain and reduced function, he said.

    "Well-fitting footwear will prevent shoes pressing or rubbing against the sensitive areas of the foot including joints that have become arthritic," said Professor Wesley Vernon, head of Podiatry Services and Research Lead at Jordanthorpe Health Centre in Sheffield, UK, who was not part of the new study.

    Many patients may be reluctant to switch to "medical" footwear because of its appearance, the experts noted.

    "Some research has shown that people, particularly women, don't like the look of this extra deep and extra wide footwear and this is not age dependent," said Anita Williams, senior lecturer in the School of Health Sciences at the University of Salford in the UK.

    In her experience, many women prefer to wear pumps, she told Reuters Health by email.

    Aside from trying new shoes, maintaining a healthy body mass index may help alleviate or prevent foot pain, Menz said.

    "It is also important that older people with foot pain consult a podiatrist, particularly if they have diabetes or changing footwear does not alleviate symptoms," he said.

    SOURCE: http://bit.ly/1mUS1CV Journal of Gerontology: Medical Sciences, online September 9, 2014.

  • Young baseball pitchers at risk for shoulder damage

    By Shereen Lehman

    NEW YORK (Reuters Health) - Teenaged baseball players who throw more than 100 pitches per week are at heightened risk of an injury that could permanently mar normal shoulder development, says a new study.

    The injury, dubbed "acromial apophysiolysis" by the authors, is characterized by incomplete fusion of the bones that form the top portion of the shoulder joint, the acromion, and local swelling and fluid (edema).

    "Over the years," said lead author Dr. Johannes Roedl, the study team had noticed young baseball players "who came in at the end of the season with shoulder pain, but with MRI imaging on which we really didn't see anything besides the abnormality, that edema at the acromion."

    Roedl, a radiologist in the musculoskeletal division at Thomas Jefferson University Hospital in Philadelphia, said that neither the radiologists nor orthopedic surgeons knew if these abnormalities were clinically relevant, but they knew something was going on, so they decided to take a closer look at all the cases they had seen.

    "We looked at all the clinical data that we had from the orthopedic surgery department," Roedl said. "In terms of how did the patients present, where was the pain, and of course, their history in terms of sports - what kind of sports did those patients play?"

    He said they were surprised at how many patients appeared to have the condition.

    "I mean it's still a relatively rare condition - only about 2.5 percent of patients at the age range between 15 and 25 who come in with shoulder pain have that acromial apophysiolysis," he said.

    Roedl said it is most likely an overuse injury from too much pitching because most of the patients who had it were "really avid pitchers - the majority pitched more than one hundred pitches per week."

    He and his colleagues reviewed medical records for more than 2,000 patients, both male and female, between the ages of 15 and 25 who had MRIs for shoulder pain between 1998 and 2012. Most of the patients were pitchers.

    A total of 61 patients had pain at the top of the shoulder and incomplete fusion of the acromion but no other radiological findings. The study team compared them to a control group of 61 similar patients who had other identifiable causes for their shoulder pain.

    The researchers found that 40 percent of the patients with acromial apophysiolysis threw more than 100 pitches per week compared to 8 percent of the control group, they report in the journal Radiology.

    One patient underwent surgery and all of the patients rested their pitching arms for three months and took nonsteroidal anti-inflammatory (NSAID) medications.

    The research team was also able to review follow-up images, either MRIs or X-rays, for 52 participants after they were 25 years old, the age when bone development would be complete. The average age at follow-up was 27 and a half, and the average interval since the original images was eight years.

    Of the 29 patients with apophysiolysis as teens, 25 showed incomplete bone fusion at the acromion at follow-up, compared to only one out of the 23 controls.

    Torn rotator cuff muscles were also more common - and worse - in the adult patients who had apophysiolysis than in the control group.

    "You can imagine if the bone in the shoulder doesn't fuse it's kind of unstable," Roedl said. "This is not a medical term, but it's essentially 'floating' and doesn't really have a fixed point."

    Roedl said that when a bone floats around it can press on tendons and those tendons can rupture or tear.

    "And that's what we saw in those patients - that they more often had tendon tears of the rotator cuff . . . so it actually had a long-term effect on those patients," he said.

    "Overall, I think it's a great radiology study. The authors describe the presentation of a new condition in a fairly large sample of patients that had previously not been done in that capacity," Kyle Aune told Reuters Health in an email.

    Aune is a clinical researcher with the American Sports Medicine Institute in Birmingham, Alabama. He wasn't involved in the study.

    But, Aune isn't yet convinced the condition is the sole cause of rotator cuff tears.

    "While possible, it is likely that these rotator cuff injuries would be due to a combination of factors including general overuse and impingement from biomechanical flaws within a pitcher's throwing mechanics," he said.

    Aune also wasn't sure that female softball pitchers should have been grouped with male baseball pitchers since the throwing motions are quite different.

    "The majority of the girls in the study played softball - it's a different pitching style, but they still have an over the head movement, and that's probably what causes the problem," Roedl said.

    Roedl added that in the future, they want to look closely at other sports to see if it's really just confined to pitching or if it's found in other athletes who use overhead motions, such as tennis, lacrosse or swimming.

    As for prevention, he said that not overdoing the same pitching motion over and over is the key.

    "It's important to pitch less than 100 pitches per week when you're young," Roedl said. "Take the off-season off, take a break of two or three months," he said.

    SOURCE: http://bit.ly/1uhaPcZ Radiology, online October 14, 2014.

Transplant Articles

  • Hospital patients rarely wash their hands, may spread disease

    By Madeline Kennedy

    NEW YORK (Reuters Health) - Although healthcare workers are urged to wash their hands often and hand sanitizer dispensers are everywhere in hospitals, patients are less scrupulous and may be contributing to the spread of hospital-acquired infections, say Canadian researchers.

    After tracking hundreds of patients in a transplant ward for nearly a year, the study team found that hand washing followed less than a third of bathroom visits, and washing or hand-sanitizer use happened only rarely after patients entered or left a room.

    "We know that certain infections can be spread on people's hands, and hand washing is an important way to prevent those infections," said the study's lead author, Dr. Jocelyn Srigley, associate medical director of infection prevention and control at Hamilton Health Sciences in Hamilton, Ontario.

    One in 25 hospital patients has at least one infection contracted at the hospital at any given time, according to the U.S. Centers for Disease Control and Prevention. The CDC estimates there were 722,000 cases of hospital-acquired infection in 2011, many of them serious or even life-threatening.

    The role of healthcare workers in transferring infectious microbes from place to place and person to person in hospitals has been well-studied, and staff are trained to take measures to avoid spreading infections.

    But just two previous studies have looked at the potential for patients to spread infections in hospitals, to others and themselves, Srigley and her colleagues write in the journal Infection Control and Hospital Epidemiology.

    The Canadian study team tracked 279 adult patients in a multiorgan transplant ward using tags attached to hospital ID bracelets that sent out ultrasound signals. Wireless receivers were installed throughout the ward to pick up the signals and track each patient's location. The system also detected every time a soap or hand sanitizer dispenser was used.

    They found that patients washed their hands about 30 percent of the time during bathroom visits, 40 percent of the time during mealtimes, 3 percent of the time while using kitchens on the wards, 3 percent of the time when entering their own rooms and 7 percent when exiting their room.

    Women washed their hands more often than men, and were more likely than men to use soap when they did. All patients were more likely to wash their hands later in the day than in the morning.

    Among 1,122 visits by 97 patients to the ward's two kitchens, only 3 percent involved hand hygiene and less than one percent involved soap.

    The researchers point to a previous study that found requiring patients to disinfect their hands four times a day significantly reduced the number of respiratory and gastrointestinal disease outbreaks in a psychiatric ward.

    Srigley noted that the ultrasound observation system was not perfect and one limitation was that it, "didn't know exactly what a patient was doing in the bathroom or when they were eating, so we don't know for sure that a patient should have washed their hands at that time."

    In addition, "not all patients agreed to wear the system tags so we don't know if the ones who wore the tags are reflective of all patients," Srigley said.

    Despite these limitations, the new technology used in the study eliminated the problem of people changing their behavior when they know they're being watched, said Dr. Yuen Kwok-yung, chair of Microbiology at the University of Hong Kong.

    Kwok-yung told Reuters Health by email, "The findings will provide important data for the formulation of hand hygiene policy."

    Srigley feels that hospitals should encourage patients to wash their hands at certain times, but she is not yet sure what would be the most effective method.

    Possibilities include "putting up posters, having someone talk to patients about hand washing, providing hand sanitizer or alcohol wipes at the bedside, etc.," she said, adding that more research is necessary to determine the most effective method.

    "The key message is that hand washing is an important way for people to protect themselves and prevent infections, whether they're in the hospital, at home, at work, or anywhere else," she said. "Especially with influenza season coming up soon, hand washing can help to keep us all healthy."

    SOURCE: http://bit.ly/1CnI4zB Infection Control and Hospital Epidemiology, Online October 2, 2014.

  • Cell transplant helps paralyzed man walk with frame

    By Kate Kelland

    LONDON (Reuters) - A Polish man who was paralyzed from the chest down in a knife attack can now walk with the aid of a frame after receiving pioneering transplant treatment using cells from his nose.

    The technique, described as a breakthrough by a study in the journal Cell Transplantation, involved transplanting what are known as olfactory ensheathing cells into the patient's spinal cord and constructing a "nerve bridge" between two stumps of the damaged spinal column.

    "We believe... this procedure is the breakthrough which, as it is further developed, will result in a historic change in the currently hopeless outlook for people disabled by spinal cord injury," said Geoffrey Raisman, a professor at University College London's (UCL) institute of neurology, who led the research.

    The 38-year-old patient, Darek Fidyka, was paralyzed after suffering stab wounds to his back in 2010. Following 19 months of treatment, he has recovered some voluntary movement and some sensation in his legs, his medics said.

    The Nicholls Spinal Injury Foundation, a British-based charity which part-funded the research, said in statement that Fidyka was continuing to improve more than predicted, and was now able to drive and live more independently.

    Raisman, a UCL spinal injury specialist, worked with surgeons at Wroclaw University Hospital in Poland to remove one of Fidyka's olfactory bulbs, which give people their sense of smell, and transplant his olfactory ensheathing cells (OECs) and olfactory nerve fibroblasts (ONFs) into the damaged area.

    They used a nerve bridge constructed between the two stumps of the damage spinal column, they said in the study.

    OECs are a type of cell found in both the peripheral and central nervous system. Together with ONFs, they make bundles of nerve fiberes that run from the nasal mucosa to the olfactory bulb, where the sense of smell is located.

    When the nerve fibers that carry smell become damaged, they are replaced by new nerve fibers that re-enter the olfactory bulbs, the researchers explained in their study.

    OECs help this process by re-opening the surface of the bulbs for the new nerve fibers to enter - leading Raisman and his team to believe transplanting OECs into the damaged spinal cord could enable severed nerve fibers to re-grow.

    Raisman added that the technique of bridging the spinal cord with nerve grafts from the patient had been used in animal studies for years, but never before in combination with OECs.

    "The OECs and the ONFs appeared to work together, but the mechanism between their interaction is still unclear," he said in a statement about the work.

    Experts not directly involved in the work said its results offered some new hope, but said more work needed to be done to figure out what had led to this success, and more patients treated, before its potential could be properly assessed.

    "While this study is only in one patient, it provides hope of a possible treatment for restoration of some function in individuals with complete spinal cord injury," said John Sladek, a professor of neurology and pediatrics at the University of Colorado School of Medicine in the United States.

    Raisman and his team now plan to repeat the treatment technique in between three and five patients over the next three to five years. "This will enable a gradual optimization of the procedures," he told Reuters.

    SOURCE: http://bit.ly/ZMtGV6 Cell Transplantation, online October 21, 2014.

  • REFILE-Giving pricey hepatitis drug to prisoners may be financially wise

    (Revises para 23 to clarify quote.)

    By Andrew M. Seaman

    NEW YORK (Reuters Health) - When prisoners have hepatitis C, treating them with expensive new antiviral drugs makes fiscal sense despite the hefty pricetag, according to a new study.

    Based on computer models, new pricey drug combinations that treat hepatitis C infections were more cost-effective than older drug combinations and no treatment at all, researchers found.

    "Essentially what our model does is follow a hypothetical cohort of prisoners that looks like a prison population in the U.S.," Jeremy Goldhaber-Fiebert told Reuters Health.

    "It allows us to ask a variety of 'what-if' questions and probe how sensitive our findings are to various factors," said Goldhaber-Fiebert, the study's senior author from Stanford University in California.

    Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. (Most commonly, this happens when people share needles, syringes, or other equipment to inject drugs - but before 1992 hepatitis C was also transmitted by blood transfusions.)

    When people are first infected, the symptoms can include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

    If left untreated, hepatitis C can slowly, over years or decades, lead to liver damage, liver failure, liver cancer, and a need for liver transplant, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

    The CDC says about 3.2 million people in the U.S. are infected with the chronic disease. Goldhaber-Fiebert and his colleagues write in Annals of Internal Medicine that about 500,000 incarcerated people have hepatitis C.

    Until recently, the virus was treated with a combination of drugs that had to be taken for about a year and caused people to have flu-like symptoms. The treatment was only effective in a minority of patients.

    The U.S. Food and Drug Administration (FDA) approved Merck's Victrelis, which is known generically as boceprevir, in 2011 to be added to the existing combination of drugs. The new combination made the treatment more effective - and more expensive (see Reuters story of May 13, 2011 here: http://reut.rs/1yg9GGm).

    Then, the FDA approved Gilead's Sovaldi, which is known generically as sofosbuvir, in 2013. The drug is taken for 12 weeks and cures a majority of patients but comes with a price tag of $84,000 (see Reuters story of December 6, 2013 here: http://reut.rs/1ygcAuT).

    Insurers have pushed back against the price of the new medication (see Reuters story of May 20, 2014 here: http://reut.rs/1ygfGPx).

    To examine benefits and costs associated with hepatitis C treatment among the U.S. prison population, the researchers used a computer model. They compared prisoners who received 12 weeks of Sovaldi plus the original drug combination, prisoners who received 28 weeks of Victrelis plus the original drug combination and prisoners who did not receive treatment.

    They examined costs of treatment in terms of quality-adjusted life years (QALY), which is the amount of time in good health that inmates could gain from the treatment.

    Overall, they found the combination of Sovaldi and the original drugs added 2.1 QALYs at a cost of about $54,000, compared to no treatment.

    The combination including Sovaldi cost about $25,700 per QALY gained among prisoners serving short sentences and about $28,800 per QALY gained among those serving long sentences. The difference in cost can be partially attributed to various factors, including the increased risk of reinfection among people still in prison, Goldhaber-Fiebert said.

    In either case, he and his colleagues found Sovaldi combination of drugs to be less expensive per QALY than the Victrelis combination.

    However, there are other challenges when choosing a hepatitis C treatment for prisoners, the researchers write.

    For example, treating U.S. prisoners infected with hepatitis C with the Sovaldi combination may come at an upfront cost exceeding $30 billion to the prison systems. The cost benefits may not be realized until the prisoners are released on another healthcare system like Medicaid, which is government-run insurance for the poor.

    "Most people in will be out," said Dr. Anne Spaulding. "We're looking at a disease that will take 30 years to progress. A lot of hepatitis C that we're not treating in the prison will end up being very costly not just for patients who are on Medicaid, but patients who do not have Medicaid who present to emergency rooms. Someone will have to pay."

    Spaulding, who wasn't involved with the new study, is an expert on hepatitis C infections among U.S. prisoners. She's an assistant professor at Emory University's Rollins School of Public Health in Atlanta.

    The U.S. Federal Bureau of Prisons currently recommends Sovaldi for many prisoners with hepatitis C infections.

    "I think the key message would be to those who control state budgets," said Spaulding. "There are benefits to considering the health of people returning to the community. There are benefits to treating hepatitis C while they're incarcerated."

    "The group that can have the most affect on increasing the new infections of hepatitis C is actually the injection drug users," she said. "If you can get rid of the hepatitis C while they're in prison, they can't spread hepatitis C when they're in the community."

    "It's a message that needs to go to the decision makers who control the purse strings," she said, adding that this is especially true for people who control state budgets.

    Goldhaber-Fiebert said prisons and jails in the U.S. should give careful consideration to the hepatitis C treatment for the population that they provide services to.

    "High-cost treatments can also be high-value if they deliver substantial enough value," he said.

    SOURCE: http://bit.ly/1zjAkCK Annals of Internal Medicine, online October 20, 2014.

  • REFILE-Giving pricey hepatitis drug to prisoners may be financially wise

    (Revises para 23 to clarify quote.)

    By Andrew M. Seaman

    NEW YORK (Reuters Health) - When prisoners have hepatitis C, treating them with expensive new antiviral drugs makes fiscal sense despite the hefty pricetag, according to a new study.

    Based on computer models, new pricey drug combinations that treat hepatitis C infections were more cost-effective than older drug combinations and no treatment at all, researchers found.

    "Essentially what our model does is follow a hypothetical cohort of prisoners that looks like a prison population in the U.S.," Jeremy Goldhaber-Fiebert told Reuters Health.

    "It allows us to ask a variety of 'what-if' questions and probe how sensitive our findings are to various factors," said Goldhaber-Fiebert, the study's senior author from Stanford University in California.

    Hepatitis C is a viral infection of the liver that is typically transmitted when the blood of an infected person enters the body of a healthy person. (Most commonly, this happens when people share needles, syringes, or other equipment to inject drugs - but before 1992 hepatitis C was also transmitted by blood transfusions.)

    When people are first infected, the symptoms can include fever, nausea, stomach and joint pain, dark urine, vomiting and a yellowing of the skin and eyes.

    If left untreated, hepatitis C can slowly, over years or decades, lead to liver damage, liver failure, liver cancer, and a need for liver transplant, according to the Centers for Disease Control and Prevention (CDC). It may also lead to death.

    The CDC says about 3.2 million people in the U.S. are infected with the chronic disease. Goldhaber-Fiebert and his colleagues write in Annals of Internal Medicine that about 500,000 incarcerated people have hepatitis C.

    Until recently, the virus was treated with a combination of drugs that had to be taken for about a year and caused people to have flu-like symptoms. The treatment was only effective in a minority of patients.

    The U.S. Food and Drug Administration (FDA) approved Merck's Victrelis, which is known generically as boceprevir, in 2011 to be added to the existing combination of drugs. The new combination made the treatment more effective - and more expensive (see Reuters story of May 13, 2011 here: http://reut.rs/1yg9GGm).

    Then, the FDA approved Gilead's Sovaldi, which is known generically as sofosbuvir, in 2013. The drug is taken for 12 weeks and cures a majority of patients but comes with a price tag of $84,000 (see Reuters story of December 6, 2013 here: http://reut.rs/1ygcAuT).

    Insurers have pushed back against the price of the new medication (see Reuters story of May 20, 2014 here: http://reut.rs/1ygfGPx).

    To examine benefits and costs associated with hepatitis C treatment among the U.S. prison population, the researchers used a computer model. They compared prisoners who received 12 weeks of Sovaldi plus the original drug combination, prisoners who received 28 weeks of Victrelis plus the original drug combination and prisoners who did not receive treatment.

    They examined costs of treatment in terms of quality-adjusted life years (QALY), which is the amount of time in good health that inmates could gain from the treatment.

    Overall, they found the combination of Sovaldi and the original drugs added 2.1 QALYs at a cost of about $54,000, compared to no treatment.

    The combination including Sovaldi cost about $25,700 per QALY gained among prisoners serving short sentences and about $28,800 per QALY gained among those serving long sentences. The difference in cost can be partially attributed to various factors, including the increased risk of reinfection among people still in prison, Goldhaber-Fiebert said.

    In either case, he and his colleagues found Sovaldi combination of drugs to be less expensive per QALY than the Victrelis combination.

    However, there are other challenges when choosing a hepatitis C treatment for prisoners, the researchers write.

    For example, treating U.S. prisoners infected with hepatitis C with the Sovaldi combination may come at an upfront cost exceeding $30 billion to the prison systems. The cost benefits may not be realized until the prisoners are released on another healthcare system like Medicaid, which is government-run insurance for the poor.

    "Most people in will be out," said Dr. Anne Spaulding. "We're looking at a disease that will take 30 years to progress. A lot of hepatitis C that we're not treating in the prison will end up being very costly not just for patients who are on Medicaid, but patients who do not have Medicaid who present to emergency rooms. Someone will have to pay."

    Spaulding, who wasn't involved with the new study, is an expert on hepatitis C infections among U.S. prisoners. She's an assistant professor at Emory University's Rollins School of Public Health in Atlanta.

    The U.S. Federal Bureau of Prisons currently recommends Sovaldi for many prisoners with hepatitis C infections.

    "I think the key message would be to those who control state budgets," said Spaulding. "There are benefits to considering the health of people returning to the community. There are benefits to treating hepatitis C while they're incarcerated."

    "The group that can have the most affect on increasing the new infections of hepatitis C is actually the injection drug users," she said. "If you can get rid of the hepatitis C while they're in prison, they can't spread hepatitis C when they're in the community."

    "It's a message that needs to go to the decision makers who control the purse strings," she said, adding that this is especially true for people who control state budgets.

    Goldhaber-Fiebert said prisons and jails in the U.S. should give careful consideration to the hepatitis C treatment for the population that they provide services to.

    "High-cost treatments can also be high-value if they deliver substantial enough value," he said.

    SOURCE: http://bit.ly/1zjAkCK Annals of Internal Medicine, online October 20, 2014.

Women’s Health Articles

  • Hospital patients rarely wash their hands, may spread disease

    By Madeline Kennedy

    NEW YORK (Reuters Health) - Although healthcare workers are urged to wash their hands often and hand sanitizer dispensers are everywhere in hospitals, patients are less scrupulous and may be contributing to the spread of hospital-acquired infections, say Canadian researchers.

    After tracking hundreds of patients in a transplant ward for nearly a year, the study team found that hand washing followed less than a third of bathroom visits, and washing or hand-sanitizer use happened only rarely after patients entered or left a room.

    "We know that certain infections can be spread on people's hands, and hand washing is an important way to prevent those infections," said the study's lead author, Dr. Jocelyn Srigley, associate medical director of infection prevention and control at Hamilton Health Sciences in Hamilton, Ontario.

    One in 25 hospital patients has at least one infection contracted at the hospital at any given time, according to the U.S. Centers for Disease Control and Prevention. The CDC estimates there were 722,000 cases of hospital-acquired infection in 2011, many of them serious or even life-threatening.

    The role of healthcare workers in transferring infectious microbes from place to place and person to person in hospitals has been well-studied, and staff are trained to take measures to avoid spreading infections.

    But just two previous studies have looked at the potential for patients to spread infections in hospitals, to others and themselves, Srigley and her colleagues write in the journal Infection Control and Hospital Epidemiology.

    The Canadian study team tracked 279 adult patients in a multiorgan transplant ward using tags attached to hospital ID bracelets that sent out ultrasound signals. Wireless receivers were installed throughout the ward to pick up the signals and track each patient's location. The system also detected every time a soap or hand sanitizer dispenser was used.

    They found that patients washed their hands about 30 percent of the time during bathroom visits, 40 percent of the time during mealtimes, 3 percent of the time while using kitchens on the wards, 3 percent of the time when entering their own rooms and 7 percent when exiting their room.

    Women washed their hands more often than men, and were more likely than men to use soap when they did. All patients were more likely to wash their hands later in the day than in the morning.

    Among 1,122 visits by 97 patients to the ward's two kitchens, only 3 percent involved hand hygiene and less than one percent involved soap.

    The researchers point to a previous study that found requiring patients to disinfect their hands four times a day significantly reduced the number of respiratory and gastrointestinal disease outbreaks in a psychiatric ward.

    Srigley noted that the ultrasound observation system was not perfect and one limitation was that it, "didn't know exactly what a patient was doing in the bathroom or when they were eating, so we don't know for sure that a patient should have washed their hands at that time."

    In addition, "not all patients agreed to wear the system tags so we don't know if the ones who wore the tags are reflective of all patients," Srigley said.

    Despite these limitations, the new technology used in the study eliminated the problem of people changing their behavior when they know they're being watched, said Dr. Yuen Kwok-yung, chair of Microbiology at the University of Hong Kong.

    Kwok-yung told Reuters Health by email, "The findings will provide important data for the formulation of hand hygiene policy."

    Srigley feels that hospitals should encourage patients to wash their hands at certain times, but she is not yet sure what would be the most effective method.

    Possibilities include "putting up posters, having someone talk to patients about hand washing, providing hand sanitizer or alcohol wipes at the bedside, etc.," she said, adding that more research is necessary to determine the most effective method.

    "The key message is that hand washing is an important way for people to protect themselves and prevent infections, whether they're in the hospital, at home, at work, or anywhere else," she said. "Especially with influenza season coming up soon, hand washing can help to keep us all healthy."

    SOURCE: http://bit.ly/1CnI4zB Infection Control and Hospital Epidemiology, Online October 2, 2014.

  • Oklahoma judge allows law banning abortion pills to take effect

    By Heide Brandes

    OKLAHOMA CITY (Reuters) - An Oklahoma judge said on Wednesday he will allow a law that bans abortion-inducing drugs to take effect as planned on Nov. 1, over the objections of abortion rights advocates who said the measure is poor public health policy that could put women at risk.

    Oklahoma District Court Judge Robert Stuart turned down a request by abortion rights groups to halt the measure from taking effect. Stuart also allowed a provision that would limit liability claims against physicians due to the law.

    According to the lawsuit filed on behalf of Reproductive Services in Tulsa and the Oklahoma Coalition for Reproductive Services this month, the measure would lead to increased use of surgically induced abortions for cases where drugs can be used.

    "This law is contrary to protecting women's health and will force doctors to use an outdated and less safe medical procedure," said Autumn Katz, staff attorney for the Center for Reproductive Rights.

    The defendants said the use of the drugs could cause harm to pregnant women because they can be used for procedures not approved by the U.S. Food and Drug Administration.

    Earlier this year, lawmakers in the heavily Republican state approved new restrictions on abortion clinics they said were aimed at protecting women's health, but abortion rights advocates said were actually intended to shut clinics.

  • Recalled, drug-tainted supplements still available for purchase

    By Kathryn Doyle

    NEW YORK (Reuters Health) - Long after the Food and Drug Administration (FDA) issued recalls for dietary supplements tainted with banned drugs, more than half of the tainted supplements were still available for purchase, a new study found.

    "There's no question that these supplements that contain pharmaceuticals are not allowed to be sold, there are clear cut laws," lead author Dr. Pieter A. Cohen told Reuters Health by phone.

    The FDA does have some loose regulatory power over supplements, which are categorized like a food, Cohen said.

    If a food manufacturer's product were tainted with salmonella, the tainted food would be recalled, the factory cleaned, and then manufacturing would continue, Cohen said. In the case of supplements, the FDA issues recalls for products tainted with dangerous pharmaceuticals, but without proper enforcement the tainted products remain on the market and some companies continue to produce more, he said.

    The FDA has identified more than 400 supplement brands tainted with pharmaceuticals, and issued a recall for 70 percent of the products.

    Cohen and his coauthors studied 27 of the 274 supplements the FDA recalled between 2009 and 2012, two-thirds of which were American-made. They bought the supplements from manufacturer websites at least eight months and up to four years after their FDA recall, then tested their chemical makeup.

    The researchers found that 18 of the 27 supplements they purchased still contained a pharmaceutical adulterant, according to results in JAMA.

    The supplements were marketed for sports enhancement, weight loss and sexual enhancement, among other things.

    Among the banned substances in the products were sibutramine, a weight loss drug linked to heart attack and stroke, and phenolphthalein, a laxative being removed from many markets due to a potential link to cancer.

    "Dietary supplement manufacturers and distributors are legally responsible for marketing a safe product that is not adulterated, and that complies with FDA's good manufacturing practice regulations for dietary supplements," the FDA told Reuters Health in a statement.

    But, the FDA warned, "The supply chain for these products is extremely fragmented; one product manufactured by an unknown company overseas may be sold by dozens of different distributors in the United States. The individuals and businesses selling these products generally are difficult to locate, operate out of residential homes, and distribute via internet, small stores, and mail. Products are shipped through the international mail facilities and are often misdeclared as unrelated goods to avoid detection. Even after recall and enforcement action against one major distributor, the product may continue to be widely sold."

    Many consumers don't realize how potent these pharmaceuticals are, Cohen said.

    "Responsible manufacturers and marketers of dietary supplements applaud strong enforcement measures by FDA to address illegal products that contain undisclosed, active pharmaceutical ingredients," Steve Mister, President and CEO of the Council for Responsible Nutrition in Washington, D.C., a dietary supplement trade association, wrote in a statement. "We have zero tolerance for this problem and welcome not only recalls, but also criminal enforcement against companies that put consumers at risk."

    Although the researchers found 27 of the 274 recalled supplements still available online from manufacturers, more may be available in shops or gas stations, where an earlier study showed most people purchase supplements, said Cohen, a professor of medicine at Harvard Medical School in Boston and an internist at the Cambridge Health Alliance.

    Also, a supplement manufacturer could easily rename its recalled product and start marketing it again without reformulation, and the FDA would have to go back and test the renamed product before issuing another recall, he said.

    Although there is a framework in place to regulate supplements, enforcement is lacking, he said.

    "There's no consequences to the manufacturer, which is absurd," he said.

    Although they aimed to purchase supplements manufactured after the FDA recall, some may have been manufactured before it, the authors note.

    Some consumers may seek these products out even though they have been recalled, but many are unaware of the recall, Cohen said.

    "This is criminal activity," said Daniel Fabricant, former Director of the Division of Dietary Supplement Programs at the FDA and current CEO of the Natural Products Association, another trade association. "There needs to be some really hardcore enforcement."

    "Consumers need to understand the risks, if they can't get an erectile dysfunction drug and they go looking for a natural product tainted with pharmaceuticals," he told Reuters Health by phone.

    Some of the recalled products have labels in mixed languages, which is also against the law, Fabricant noted.

    "Right now my recommendation is for consumers to avoid muscle building supplements, weight loss and sexual enhancement supplements," which are most likely to contain dangerous drugs, Cohen said.

    These supplements either do not work or are tainted with pharmaceuticals, he said.

    Many vitamin and mineral supplements are safe, especially those sold as single ingredients, he said. Products made up of a "cocktail" of ingredients are more likely to be tainted, he said.

    SOURCE: http://bit.ly/1c9i5E4 JAMA, October 21, 2014.

  • People picking up lung meds at CVS often bought cigarettes, too: study

    By Kathryn Doyle

    NEW YORK (Reuters Health) - Before the CVS pharmacy chain stopped selling cigarettes, some patients who were filling prescriptions for health conditions caused or worsened by smoking also bought cigarettes at the stores, according to a new study of the company's purchasing data.

    "We were interested in assessing the extent to which patients purchase cigarettes from pharmacies where they were also filling prescriptions for these drugs," said Joshua J. Gagne of Brigham and Women's Hospital and Harvard Medical School in Boston, who coauthored the new research letter.

    Executives at CVS Caremark Corp. announced in February that it would stop selling cigarettes at its 7,600 store locations by October of this year, the first U.S. drugstore chain to do so, although some cities like Boston and San Francisco already keep tobacco products out of pharmacies.

    For the new study, researchers used data on more than 360,000 Caremark pharmacy members who filled a prescription for a statin medication, used to treat high cholesterol, in 2011 or 2012.

    Of those, 38,939 were taking medication for asthma, chronic obstructive pulmonary disease (COPD), or high blood pressure or were using an oral contraceptive.

    Smoking can cause or worsen COPD, asthma and high blood pressure. It can also dramatically increase the risk of serious cardiovascular events associated with oral contraceptives, for which side effects are usually rare, Gagne said.

    Six percent of asthma or COPD medication users, 5.1 percent of blood pressure medication users and 4.8 percent of oral birth control medication users purchased cigarettes at least once with their CVS rewards card while they had those medications available to use, according to results in JAMA Internal Medicine.

    "It is discouraging to me that pharmacies sell cigarettes and other tobacco products that could worsen health and make the prescription medications that they dispense less effective or even more dangerous," Gagne told Reuters Health by email.

    The researchers did not examine how frequently cigarettes and these prescription meds were actually purchased at the same time and on the same receipt, and some of the purchases could have been made by other family members using the same CVS loyalty card, the authors note.

    "In some instances people purchased cigarettes during the same visit that they filled the prescription, but not always," Gagne said. "We did, however, assess cigarette purchases only while people had medication available by requiring either that the cigarette purchase and prescription fill occur on the same day or that the cigarette purchase happen shortly after the prescription fill while the individuals were likely using the medications."

    According to the CDC, 18 percent of adults in the U.S. are smokers. Although less than 18 percent of the patients in this data set purchased cigarettes at their CVS pharmacies, others may have been purchasing them at other locations, Gagne said.

    Smokers in focus groups in New York, California and Ohio have said they tend not to buy cigarettes at drug and grocery stores, because they are often more expensive than other retailers, said Patricia McDaniel, associate professor in sociology in the School of Nursing at the University of California, San Francisco.

    She was not involved in the new study.

    McDaniel researches stop-smoking policy. Increasing tobacco taxes, directing more money from those taxes to tobacco control programs, including money for media campaigns that denormalize smoking and the tobacco industry, reducing the retail availability of tobacco products, and passing clean indoor air laws are effective policies for smoking cessation, she told Reuters Health by email.

    "Stopping the sale of tobacco in drug stores sends a consistent health message: we sell medications to improve your health, we don't sell the single most deadly consumer product ever made," she said.

    Pharmacies should not be among the places people can purchase cigarettes, Gagne said.

    "Short of banning cigarettes completely, getting people to stop smoking is very difficult and requires a complex solution," he said. "Pharmacies should be part of the solution rather than part of the problem."

    SOURCE: http://bit.ly/1vYoKuk JAMA Internal Medicine, October 20, 2014.

  • Petition calls on Roche to cut breast cancer drug price

    By Reuters Staff

    LONDON (Reuters) - A British-led petition signed by 29,000 people has demanded that Switzerland's Roche, the world's biggest maker of cancer medicines, cut the price of its expensive new breast cancer drug Kadcyla.

    The campaign shows the growing pressure on drug companies as a raft of promising new cancer treatments reach the market. U.S. insurers also say they are alarmed by a coming flood of cancer medicines with "astronomical price tags," while pricing rows have flared in France and Italy.

    Kadcyla can add about half a year to the lives of some women with inoperable breast cancer but Britain's cost watchdog NICE estimates it costs about 90,000 pounds ($145,000) per patient and is too pricey for the state-run health service.

    Roche argues the cost reflects the benefits offered by its innovative treatment. It also disputes the headline price cited by the National Institute for Health and Care Excellence (NICE).

    NICE bases its calculation on a mean treatment course of 14.5 months, whereas the median length of treatment in clinical trials -- the measure Roche believes is more relevant -- was 9.6 months, reducing the cost per patient significantly.

    The Care2 petition, calling on Roche Chief Executive Severin Schwan to reduce the price of Kadcyla to a level public health services can afford, was started by British breast cancer survivor Margaret Connolly.

    Kadcyla combines the antibody used in Roche's established Herceptin drug and a tumor-killing payload that is delivered directly into cancer cells, causing fewer chemotherapy-related side effects such as hair loss.

    It is one of a number of targeted therapies that are revolutionizing cancer care. Other promising new approaches include a range of drugs to help the immune system fight cancer, which also carry a high price.