Alexza's agitation drug gets FDA approval

Alexza Pharmaceuticals Inc said the U.S. health regulators approved Adasuve, making it the first treatment for schizophrenia and bipolar disorder that can be inhaled. Adasuve, which delivers an older antipsychotic drug called loxapine, passes through the lungs and into the bloodstream faster than a typical pill. Loxapine is available as an oral drug for schizophrenia. The company said the product will include a boxed safety warning about potentially dangerous side effects including the potential for fatal bronchial spasms in people with asthma or chronic obstructive pulmonary disorder and a higher risk of death in elderly people with dementia-related psychosis. Adasuve use will be restricted to mitigate the potential harm of bronchial spasms, Alexza said. The FDA also required Alexza to conduct a large post- marketing clinical trial of patients to assess the real-world use of the drug. "We believe that the ability to deliver medications rapidly and non-invasively will be important for patients and the professionals who care for them," Chief Executive Thomas King said in the statement. Three injectable drugs, Bristol-Myers Squibb's Abilify, Eli Lilly's Zyprexa and Pfizer Inc's Geodon, are currently approved to calm patients with schizophrenia or bipolar disorder. Adasuve, Alexza's most advanced drug, will be available for commercial launch early in the third quarter of 2013, the company said. Earlier this month, European health regulators recommended approval of Adasuve. The FDA denied approval to Adasuve in May, after it found deficiencies at the company's Mountain View, California manufacturing facility during an inspection. The company's shares fell 12 percent in the after market trading after the trade was halted at $5.79 before the drug- approval announcement.

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Predicting who's at risk for violence isn't easy

It happened after Columbine, Virginia Tech, Aurora, Colo., and now Sandy Hook: People figure there surely were signs of impending violence. But experts say predicting who will be the next mass shooter is virtually impossible — partly because as commonplace as these calamities seem, they are relatively rare crimes. Still, a combination of risk factors in troubled kids or adults including drug use and easy access to guns can increase the likelihood of violence, experts say. But warning signs "only become crystal clear in the aftermath, said James Alan Fox, a Northeastern University criminology professor who has studied and written about mass killings. "They're yellow flags. They only become red flags once the blood is spilled," he said. Whether 20-year-old Adam Lanza, who used his mother's guns to kill her and then 20 children and six adults at their Connecticut school, made any hints about his plans isn't publicly known. Fox said that sometimes, in the days, weeks or months preceding their crimes, mass murderers voice threats, or hints, either verbally or in writing, things like "'don't come to school tomorrow,'" or "'they're going to be sorry for mistreating me.'" Some prepare by target practicing, and plan their clothing "as well as their arsenal." (Police said Lanza went to shooting ranges with his mother in the past but not in the last six months.) Although words might indicate a grudge, they don't necessarily mean violence will follow. And, of course, most who threaten never act, Fox said. Even so, experts say threats of violence from troubled teens and young adults should be taken seriously and parents should attempt to get them a mental health evaluation and treatment if needed. "In general, the police are unlikely to be able to do anything unless and until a crime has been committed," said Dr. Paul Appelbaum, a Columbia University professor of psychiatry, medicine and law. "Calling the police to confront a troubled teen has often led to tragedy." The American Academy of Child & Adolescent Psychiatry says violent behavior should not be dismissed as "just a phase they're going through." In a guidelines for families, the academy lists several risk factors for violence, including: —Previous violent or aggressive behavior —Being a victim of physical or sexual abuse —Guns in the home —Use of drugs or alcohol —Brain damage from a head injury Those with several of these risk factors should be evaluated by a mental health expert if they also show certain behaviors, including intense anger, frequent temper outbursts, extreme irritability or impulsiveness, the academy says. They may be more likely than others to become violent, although that doesn't mean they're at risk for the kind of violence that happened in Newtown, Conn. Lanza, the Connecticut shooter, was socially withdrawn and awkward, and has been said to have had Asperger's disorder, a mild form of autism that has no clear connection with violence. Autism experts and advocacy groups have complained that Asperger's is being unfairly blamed for the shootings, and say people with the disorder are much more likely to be victims of bullying and violence by others. According to a research review published this year in Annals of General Psychiatry, most people with Asperger's who commit violent crimes have serious, often undiagnosed mental problems. That includes bipolar disorder, depression and personality disorders. It's not publicly known if Lanza had any of these, which in severe cases can include delusions and other psychotic symptoms. Young adulthood is when psychotic illnesses typically emerge, and Appelbaum said there are several signs that a troubled teen or young adult might be heading in that direction: isolating themselves from friends and peers, spending long periods alone in their rooms, plummeting grades if they're still in school and expressing disturbing thoughts or fears that others are trying to hurt them. Appelbaum said the most agonizing calls he gets are from parents whose children are descending into severe mental illness but who deny they are sick and refuse to go for treatment. And in the case of adults, forcing them into treatment is difficult and dependent on laws that vary by state. All states have laws that allow some form of court-ordered treatment, typically in a hospital for people considered a danger to themselves or others. Connecticut is among a handful with no option for court-ordered treatment in a less restrictive community setting, said Kristina Ragosta, an attorney with the Treatment Advocacy Center, a national group that advocates better access to mental health treatment. Lanza's medical records haven't been publicly disclosed and authorities haven't said if it is known what type of treatment his family may have sought for him. Lanza killed himself at the school. Jennifer Hoff of Mission Viejo, Calif. has a 19-year-old bipolar son who has had hallucinations, delusions and violent behavior for years. When he was younger and threatened to harm himself, she'd call 911 and leave the door unlocked for paramedics, who'd take him to a hospital for inpatient mental care. Now that he's an adult, she said he has refused medication, left home, and authorities have indicated he can't be forced into treatment unless he harms himself — or commits a violent crime and is imprisoned. Hoff thinks prison is where he's headed — he's in jail, charged in an unarmed bank robbery.

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Hepatitis C tests continue after NH tech's arrest

Hospitals across the country recommended hepatitis C testing for about 7,900 patients last summer after a traveling medical worker was accused of stealing drugs and infecting patients with tainted syringes in New Hampshire. But five months later, nearly half of those who were possibly exposed to the liver-destroying disease in other states have yet to be tested. Described by prosecutors as a "serial infector," David Kwiatkowski is accused of stealing syringes of the powerful painkiller fentanyl from the cardiac catheterization lab at New Hampshire's Exeter Hospital and replacing them with saline-filled syringes tainted with his own blood. In jail since his arrest in July, he pleaded not guilty to 14 federal drug charges earlier this month and is expected to go to trial next fall. Before April 2001, when he was hired in New Hampshire, Kwiatkowski worked as a traveling cardiac technologist in 18 hospitals in seven states, moving from job to job — despite being fired twice over allegations of drug use and theft. Thirty-two people in New Hampshire have been diagnosed with the same strain of hepatitis C that Kwiatkowski carries, along with six in Kansas, five in Maryland and one in Pennsylvania. At least 3,700 people outside New Hampshire have yet to be tested, hospitals and public health officials told The Associated Press. For example, in Michigan, where Kwiatkowski grew up and started his career, about 2,300 patients at five hospitals were notified that they may have been exposed to hepatitis C by Kwiatkowski. As of early December, only about 500 had gone in for testing, none of whom were diagnosed with a strain linked to the New Hampshire outbreak, according to the Michigan Department of Community Health. In Pennsylvania, 2,280 patients at the University of Pittsburgh Medical Center Presbyterian were notified that they should get tested, but only 840 have, one of whom was diagnosed with a matching strain of hepatitis C. Kwiatkowski was fired a few weeks into his temporary job at UPMC in 2008 after a co-worker accused him of swiping a fentanyl syringe from an operating room and sticking it down his pants. Citing a lack of evidence, hospital authorities didn't call police, and neither the hospital nor the medical staffing agency that placed him in the job informed the national accreditation organization for radiological technicians. Within days, Kwiatkowski was starting a new job at the Baltimore VA Medical Center, where one patient also has since been diagnosed with hepatitis C linked to Kwiatkowski. Though the VA center initially said it had identified 168 patients who may have been exposed, that number was later lowered, and 68 patients ultimately were tested. Two other Maryland hospitals where Kwiatkowski worked also have completed their testing, with no diagnosed cases of hepatitis C matching Kwiatkowski. But at the fourth, The Johns Hopkins Hospital in Baltimore, four patients have been diagnosed with the strain of disease linked to Kwiatkowski. About 500 of the 1,567 patients notified by Johns Hopkins have yet to be tested, according to hospital spokeswoman Kim Hoppe. Kwiatkowski had been referred by a staffing agency that assured Johns Hopkins that it had followed a vigorous vetting process, Hoppe said. He worked there for two 13-week stints, from July 2009 to January 2010. Saint Francis Hospital in Poughkeepsie, N.Y., where Kwiatkowski worked in late 2007 and early 2008, notified and tested 31 patients without finding any linked cases to Kwiatkowski. In Kansas, nearly all of the 416 patients who may have been exposed at Hays Medical Center have been tested and six have been diagnosed with infections linked to the New Hampshire outbreak. There have been no cases linked to Kwiatkowski in Arizona, where about 300 patients from two hospitals have been asked to get tested and about 280 have done so. Kwiatkowski worked at Maryvale Hospital in Phoenix in 2009 and the Arizona Heart Hospital in 2010. He was fired from the latter job after 10 days after a co-worker found him passed out in a bathroom stall with a stolen fentanyl syringe floating in the toilet. That incident was reported to police, Kwiatkowski's staffing agency, a state regulatory board and the national accreditation organization, but the accreditation group dropped its inquiry after learning police hadn't filed charges. Days later, Kwiatkowski landed a new job filling in for striking technicians at Temple University Hospital in Philadelphia. That hospital has recommended testing for 312 patients but won't say how many have followed through or have been diagnosed with hepatitis C. A hospital spokesman referred questions to the city health department, which did not return calls. Testing also is still under way in the last place Kwiatkowski worked before heading to New Hampshire — Houston Medical Center in Warner Robins, Ga. According to the hospital, fewer than 100 people have yet to be tested, and there haven't been any cases yet linked to Kwiatkowski. In New Hampshire, where about 3,300 patients were tested, Kwiatkowski is charged with seven counts of illegally obtaining drugs and seven counts of tampering with a consumer product, though prosecutors have said further charges are possible. Although New Hampshire cannot charge him for possible violations in other states, it can use evidence gathered in those jurisdictions in its trial, U.S. Attorney John Kacavas said. Other states are waiting to see the outcome of New Hampshire's case before deciding whether to file charges, he said. "We continue to reach out to other states affected by this matter," Kacavas said this week. "Other health organizations and departments continue to do their work in their states, but nothing has changed in the sense that our prosecution will go forward. At this point, we are the only prosecution in the country, and we'll see how it rolls out.

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FDA warns doctors of counterfeit Botox

Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe. The Food and Drug Administration said in a letter sent last month, a letter released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety. The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs. The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs. In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs. A request for comment from the drug distributor was not immediately returned. Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients. In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday. Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG's Genentech unit.

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Little change in overtreatment at doctors' offices

Although some Americans are getting more of beneficial treatments that were underused in the past, including drugs for heart disease, others are still being overtested or overtreated for a range of conditions, according to a new study. Researchers found U.S. doctors' offices made progress on six of nine "quality indicators" for recommended and underused therapies but only scaled back on two of 11 unnecessary and potentially harmful health services. Those findings reflect a growing concern over skyrocketing health care costs - and the realization that doctors and hospitals are going to have to find places where services can be scaled back. "We all know that we need to do something about it, and one component of the high health care costs is the overuse and misuse of therapies and interventions," said Dr. Amir Qaseem, director of clinical policy at the American College of Physicians. It's not about getting rid of services that are too expensive, he told Reuters Health, but evaluating what current tests and treatments may offer little value for certain patients. For example, two overuse indicators included in the new analysis are screening men age 75 and up for prostate cancer and screening women 75 and older for breast cancer. "For men who are getting screened over the age of 75, the likely benefit doesn't happen within a patient's lifetime," Qaseem said, because prostate cancer is often very slow-growing. And that's assuming prostate specific antigen (PSA) tests are beneficial at all. Regardless of a man's age, however, the tests can still lead to invasive biopsies that come with side effects such as a risk of incontinence and impotence. "We really need to start looking at some of these services that may be harmful," added Qaseem, who wasn't involved in the new research. The findings are based on nationally representative studies of adult care in outpatient offices, conducted by the Centers for Disease Control and Prevention. Data came from 79,083 office visits in 1998-1999 and 102,980 visits in 2008-2009. During that span, the use of many recommended therapies improved. For example, 28 percent of people with coronary artery disease were given aspirin in 1998-1999, compared to almost 65 percent a decade later. Likewise, the use of statins more than doubled in those same patients, from 27 percent to 59 percent. In people with diabetes, statin prescriptions increased from 12 percent to 36 percent. However, there was little change in rates of unnecessary and overused services, including some types of cancer screening for older adults or x-rays and urine tests done as part of a general check-up. Two of those overuse indicators improved: cervical cancer screening for women over 65 dropped from 3 percent to 2 percent, and unnecessary antibiotic prescribing for asthma flare-ups fell from 22 percent to 7 percent. On the other hand, rates of prostate cancer screening for older men increased, from between 3 and 4 percent to almost 6 percent, according to findings published Monday in the Archives of Internal Medicine. The lead author on the study from New York's Mount Sinai School of Medicine, Dr. Minal Kale, said the set of quality indicators her team used doesn't necessarily represent all tests and treatments provided in outpatient care. And she added that the overuse of medical services is a complicated issue. "Culturally, there's a lot of resistance to limiting access to health care services because it quickly becomes politicized," Kale told Reuters Health. "The question about overuse really needs to come back to quality. It's about quality of the care that we're delivering to patients." The goal, she said, is to "increase the value and the quality of our health care system while also paying attention to the costs."

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Twins have simultaneous and free hip replacements

BENSALEM, Pa. (AP) — To make the high school cheerleading team 40 years ago, twins Deborah and Sandra Fanelli performed an acrobatic move called "the flying splits." The memory recently drew a rueful laugh from the once-active sisters, who in recent years have had trouble simply walking. Severe arthritis has nearly crippled Sandra, known as Sam, who uses a walker. Deb has relied on a cane. But on Friday, the 56-year-old twins, who have lived their entire lives together, were wheeled into side-by-side operating rooms at Rothman Orthopaedic Specialty Hospital in the Philadelphia suburb of Bensalem. Deb received a right hip replacement and Sam had surgery on both hips as part of Operation Walk USA, a program that offers free knee and hip replacements to uninsured patients like the Fanellis. "I'm just incredibly grateful and in awe of this procedure," Sam said, just hours after surgery as she took her first steps down a hospital corridor to visit her sister. Doctors, hospitals and implant manufacturers donate time and equipment for the procedures. A hip replacement would normally cost about $16,000, plus hospitalization, according to Rothman officials. The program started in the mid-1990s to serve patients in developing countries but has been offered in the U.S. for only the past two years. The Fanelli twins were among five patients at Rothman, and among 200 people nationwide, receiving free new joints on Friday. The sisters had become increasingly debilitated with arthritis after dancing and singing professionally for 20 years, including eight years at a casino in Atlantic City, N.J. They have been living in their childhood home in Clementon, N.J., with their spry and doting 81-year-old mother, Blanche, who has watched with alarm as her daughters' conditions have deteriorated. "Because I'm not a young person," Blanche said in an interview Thursday. "And I thought, 'Oh, my gosh, who's going to take care of them?'" Over the past few years, Sam has run a small gourmet cookie business out of the house and Deb has sold cosmetics. But their outings have been minimal, limited mainly to the grocery store and their parish church. "It's hard to even get up some days," Deb said. "The hip pain and the limitations have robbed us of our freedom and robbed us of our, just, mental joy, to get up and live." Sam's problems started about 10 years ago. One hip became so painful that their father paid for an experimental replacement procedure in 2003, but Sam saw little improvement. Deb's leg gave out a couple of years later and has gotten progressively worse. The twins have never had health insurance. Then earlier this year, a friend told them about Operation Walk USA. The family was overcome with joy when they found out both sisters qualified for free surgery. Dr. Bill Hozack, who gave Sam a new left hip and fixed the old replacement on her right hip, said the operations went well. "Assuming everything heals properly, no complications — which is usually the case — they should be able to go out and do everything they want to do and not have any problems with the hips," Hozack said. For now, the sisters must recover and begin re-learning to walk on their new joints. After a tearful reunion in Deb's hospital room Friday afternoon, they said they looked forward to this new phase in their lives. "I'm flabbergasted. I'm overwhelmed," Deb said. "The worst is behind us. We're going to be great." A day earlier, the twins had said one of their first goals is to participate this spring in a fundraising walk for ovarian cancer, in memory of a dear friend. "The first year we went to participate, we had to sit on the sidelines and just kind of watch everybody," Deb said. "So this year, we want to get out there and walk." "Definitely," added Sam. "I can't wait."

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