Personal Health: Excessive Hair-Pulling

Published on July 13, 2009 in THE PHILADELPHIA INQUIRER.

An aid in cases of hair pulling
A common dietary supplement containing an amino acid may help people with trichotillomania, also known as compulsive hair pulling, according to a study by researchers at the University of Minnesota School of Medicine in Minneapolis.

The amino acid N-acetylcysteine occurs naturally in the body and is sold in pill form in health-food stores.

Two to four percent of the U.S. population suffer from trichotillomania, a physically, emotionally and socially damaging condition that often coexists with other psychological disorders.

Fifty sufferers - 45 women and five men, with an average age of 34 - were randomly assigned to take 1,200 milligrams to 2,400 milligrams of N-acetylcysteine or a placebo for 12 weeks. Most were also receiving psychotherapy or psychotropic drugs.

After nine weeks, more than half of the supplement-takers reported improvement - such as reduced hair-pulling urges and fewer hair-pulling episodes - compared with 16 percent of those on the dummy pills. The positive response continued for the remaining three weeks.

The study is reported in the July issue of Archives of General Psychiatry.

- Heather J. Chin

Personal Health: On Statins and Walking Aids

Published on Monday, July 6, 2009 in THE PHILADELPHIA INQUIRER.

Likely benefits to prescribing statins to curb heart disease

Cholesterol-lowering statin drugs, the standard of care for people with heart disease, may also benefit many patients who are merely at risk of developing the disease, researchers report in a review of 10 previous studies involving 70,000 people worldwide.

Prescribing statins as a preventive measure to patients with risk factors such as diabetes and high blood pressure was associated with a 30 percent drop in major heart disease and a 12 percent drop in deaths over an average of four years, researchers said on bmj.com, an online British medical journal.

Statins are powerful drugs, and the researchers - several of whom reported support in the past from manufacturers - stopped short of recommending their use for all people at risk of developing heart disease.

While men over 65 who have other risk factors and older women with diabetes and other risk factors appear to be most in danger of developing heart disease, they write, "the correct identification of such people remains a challenge," as does prediction of an individual's risk. - Heather J. Chin


Study of falls suggests need to teach safer use of walkers

More than 47,000 older Americans a year - 129 a day - seek treatment at hospitals after falls involving walkers or canes, according to a six-year review of ER records that suggests more time should be spent teaching people how to use walking aids.

Falls are the leading cause of injuries in people over 65. Less than 3 percent involve walking aids, but the researchers, from the U.S. Centers for Disease Control and Prevention, said they were the frailest and most vulnerable population. And while twice as many older people use canes than use walkers, the researchers found seven times as many injuries associated with walkers.

Fractures were the most common type of injury. Men injured their head and neck most frequently, while women hit their hip or pelvis. Women, who are more likely to use walkers, made up 77 percent of all falls examined.

The goal now, the authors write in the Journal of the American Geriatrics Society, is to identify potential risk factors that lead to falls, to design better walking aids, and to provide education on safe usage. Information about falls and how to prevent them: http://go.philly.com/health. - Heather J. Chin

Philly Local: Philadelphia VA Prostate Cancer Scandal

Published on June 23, 2009 in THE PHILADELPHIA INQUIRER.
I contributed some reporting to this story.

Specter plans hearing on VA prostate cancer treatment


By Marie McCullough
Inquirer Staff Writer

Four years ago, after talking to doctors at the Philadelphia VA Medical Center, the Rev. Ricardo Flippin opted for a radiation therapy that would precisely target his prostate cancer and leave nearby organs unharmed.

Instead, his prostate cancer got too little radiation while his rectum received so much that he suffered excruciating, permanent damage.

Flippin, 68 - a minister, teacher, and Air Force veteran - is hardly unique.

The Philadelphia VA has notified 92 prostate cancer patients treated between 2002 and 2008 that their "brachytherapy" radiation doses were too high or too low. The U.S. Department of Veterans Affairs has shut down the brachytherapy program in Philadelphia and three other VA hospitals with less serious problems.

Yesterday, the unfolding scandal prompted Sen. Arlen Specter (D., Pa.) to say he would hold a hearing on the matter in Philadelphia on Monday.

Read more here...

MEDICAL NEWS: First Treatment For Huntington's Approved By FDA

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/19/2008

A drug called Xenazine (tetrabenazine) has been approved by the U.S. Food and Drug Administration as the first treatment for chorea, the involuntary jerking movements that are a symptom of Huntington's Disease.

The drug addresses only specific symptoms, however, and does not target the complete condition. It is also not without major side effects, notes the FDA, such as suicidal thoughts and depression, especially in patients already predisposed to those conditions. Other side effects include drowsiness, insomnia, nausea and restlessness.

Xenazine works by suppressing the ability of dopamine - a neurotransmitter responsible for improving nerve conduction - to communicate with certain nerve cells in the brain, resulting in an over-active system.

Huntington's Disease, or chorea major, is a rare inherited neurological disorder that affects physical, cognitive and behavioral ability - a person's coordination, speech, thought processes and muscle control. Patients with chorea are at higher risk of fall-related injuries.

About 30,000 Americans are currently affected and another 200,000 are at risk of developing the genetic disorder. Symptoms usually manifest between the ages of 30 and 50.

Xenazine should be available by prescription by the end of the year and given the FDA-approval, it is likely (although uncertain) that Medicare and other government or private insurance plans would cover the drug's cost.

The medication is already available in Australia, Canada and Europe and is manufactured by the Washington, D.C.-based Prestwick Pharmaceuticals.

Heather J. Chin can be reached at hchin@thebulletin.us.

©The Evening Bulletin 2008

MEDICAL POLICY: State, Medicaid Enact Cost-Cutting Measures

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/13/2008

The Pa. Department of Public Welfare (DPW) last week added early refills of prescription drugs to the state's list of Medicaid services and items that require prior authorization.
An "early refill" is a request for a refill when over 25 percent of the previously filled prescription would normally remain if followed properly. Requiring approval is aimed at preventing people from "stockpiling" medications.

Refilling prescriptions early resulted in Medicaid payments being paid for more than 12 months worth of prescriptions over a 12-month period, according to Stacey Witalec, a DPW spokeswoman.

The DPW's change was made on Aug. 4 and is expected to save the state more than $2.5 million on the purchase of medicines in the 2009 fiscal year. It comes after a failed bid by DPW to take over management of the state Medicaid program's prescription drug program. Matching federal Medicaid dollars would provide a total savings of $5.4 million in 2009 and $6.5 million for fiscal year 2010.

In a similar effort to both cut costs and promote more responsible health care, Philadelphia's three Medicaid HMO plans are following the DPW's lead in not paying hospitals for added costs that result from preventable medical errors.

The DPW estimates that "hundreds of millions of dollars" will be saved under this program, Ms. Witalec said.

Keystone Mercy Health Plan will implement the policy beginning on Oct. 1. The company serves over 293,000 residents, making it the region's largest Medicaid managed-care company.

After Oct. 1, all hospital claims will be required to indicate that the medical condition for which the patient received care was "present at admission" - that it existed before the patient was admitted to the hospital, said Dr. Jay Feldstein, Keystone Mercy's chief medical officer.

Dr. Feldstein said Keystone Mercy have met with its provider hospitals throughout the year to outline the new policy. Provider hospitals covered by the company will retain the right and ability to appeal what DPW has defined as a "preventable serious adverse event."

A hospital trade group, Delaware Valley Healthcare Council (DVHC), has created a team of clinicians and hospital administrators to discuss and review the policies of the Medicaid managed-care companies.

"We're looking for [the HMO's] policies to be clinically sound and financially fair," said Kenneth J. Braithwaite II, a regional executive for the DVHC.

Health Partners, the Philadelphia area's largest not-for-profit health plan serving Medicaid patients, is in the early stages of developing its policy, according to spokeswoman Felicia Phillips.

Health Partners serves over 135,000 members in southeastern Pa. and is owned by a group of seven Philadelphia hospitals, including St. Christopher's Hospital for Children and the Hospital of the University of Pa.

Similarly, AmeriChoice of Pa. has just begun work on how to implement such a policy, Steve Matthews, a spokesman for the company told a local publication. The Philadelphia-based subsidiary of United Health Group has 75,000 members in the five-county area.

DPW's original program, which began in January, was developed to identify and stop Medicaid payments to hospitals for preventable mistakes that result in a serious negative outcome. The program was created in coordination with the Hospital & Health System Association of Pa., a state trade group.

This applies to 27 types of medical errors, or "never events," such as medication mistakes, bad blood transfusions and operating on a wrong body part.

Also in October, the federal Medicare program will stop paying hospitals for procedures and treatment of hospital-acquired conditions in eight categories that cover medical errors, injuries and infections that are judged to "reasonably have been prevented."

New Jersey health officials are waiting for the national program to begin before adopting a state policy of their own.

Heather J. Chin can be reached at hchin@thebulletin.us.

©The Evening Bulletin 2008

HEALTH: Study: Americans Drinking Less Alcohol, More Wine

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/12/2008

Americans may drink more in one sitting than some Europeans (who drink steadily in small amounts), but their average overall alcohol intake has decreased across age and gender differences, according to a study published last week in the American Journal of Medicine.

The results from a 55-year study (1948-2003) on 8,600 white adults in Framingham, Mass., found Americans drink less as they get older, and they tend to gravitate away from beer and toward wine in the process. Each successive generation also showed a trend from heavier drinking toward moderate drinking.

All participants were initially at least 28 years old and were born between 1900 and 1959.
The average amount of alcohol intake was highest between ages 30 and 50 for most cohorts, regardless of gender.

Up to their mid-30s, young men relied on beer for at least half of their alcohol consumption. After that, beer consumption dropped to around one-quarter of the average male in his mid-70s.

While both men and women in each generation drank less with age and each generation drank less than the generation before it, the overall incidence rate of an alcohol use disorder among those aged 40 to 79 years was about three times higher among men (12.8 percent) than women (3.8 percent).

Female participants also showed a move from beer to wine over time, although the report's authors noted that they were less partial to beer to begin with. No significant alcohol-related problems were linked with women here, but a report by University of Washington researchers in the May issue of Alcoholism: Clinical and Experimental Research found that women born after 1953 had rising rates of alcoholism.

Lead author Yuqing Zhang, D.Sc., of the Boston University School of Medicine, told WebMD he doesn't know why the rates of alcohol use dropped over generations and this study "did not try to answer these questions."

The long-term health study collected data by asking participants to answer questions about their lifestyle and health, including alcohol consumption over time. Researchers hoped that the data would help determine patterns of alcohol use and disorders according to sex, age and birth cohorts.

The study, supported by a grant from the National Institute on Alcohol Abuse and Alcoholism (part of the National Institutes of Health), is not clearly representative of all U.S. adults, but researchers said the data supports the efficacy of efforts to reduce alcohol use disorders.

Researchers also hope the data may be useful for policy-making groups responsible for drinking and alcohol recommendations, continuing "to support potentially beneficial effects of moderate drinking on cardiovascular disease and other diseases of aging, as well as adverse health and social effects of heavy alcohol use."

Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

MEDICINE: Aetna-Wharton To Test Paying Patients To Take Their Heart Meds

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/11/2008

Researchers at the University of Pennsylvania's Wharton School are studying whether daily lottery cash incentives of $10 and $100 will help improve the likelihood of patients' taking their prescribed medication.

The research will begin this fall and take place over a six-month period, with results being available in March of next year.

The Aetna Foundation, the non-profit arm of the national health insurer, is sponsoring the study with a $400,000 grant. Philadelphia is a designated community under the foundation's Healthy Community Grants Program and Healthy Community Outreach Program.

Dr. Kevin G. Volpp, director of the Center on Health Incentives at Wharton's Leonard Davis Institute for Health Economics, explained that since people often stop taking medication within a few days, potential health benefits cannot be realized.

"People find it difficult to do things long term [like taking medication] in the short term [on a daily basis]," Dr. Volpp said. "A lot of behavioral economic research shows that people tend to weigh the present more heavily as opposed to [a] future decision."

So he and colleagues designed a two-arm randomized trial based on a system of feedback and incentives and proposed it to Aetna. The trial would enroll 100 participants to test a daily lottery as incentive for taking Warfarin, a blood thinner prescribed to prevent swelling and blood clots.

An electronic monitor would connect to pill boxes, tracking whether each participant takes his or her medicine. Participants would receive daily text messages saying whether he or she has won the lottery, or, if the dose was missed, whether they would have won.

An incentive group of 50 people would have a 1-in-10 chance of winning $10 for every day they take their medication and a 1-in-100 chance of winning $100. A control group of 50 people would use the same electronic monitor but not be entered into the lottery.

According to Dr. Troyen A. Brennan, Aetna's Chief Medical Officer, they chose to sponsor the trial because adherence is key to quality of care and statistics show that a year after beginning medication, only about 50 percent of patients are taking medications as directed. "If it looks like it works, we'll try to incorporate it in things we do," he said.

For Dr. Volpp, the trial's co-founder, this is just one of many possibilities in using behavioral economic tools towards strengthening health applications.

"There is a synergy between health professionals who want people to adopt healthy behaviors and commercial interests who want to find ways to effectively make sure that people ... behave in healthy ways in higher rates," Dr. Volpp said. "I think there are big opportunities to try to think creatively about how to use incentive systems to try to help people adopt healthy behaviors at higher rates."


Heather J. Chin can be reached at hchin@thebulletin.us.

©The Evening Bulletin 2008

HEALTH: Psychiatrists Are Prescribing More Pills, Less Therapy

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/07/2008

With Sigmund Freud and HBO's popular series "In Treatment" featuring a psychiatrist and his patients, it seems a safe bet that paying someone to analyze your life is still a strong option.

However, a new report published in the Archives of General Psychiatry this Monday reveals that fewer psychiatrists are providing psychotherapy to patients during office visits, instead prescribing drug therapy - medication - at increasing rates.

According to the researchers, the trend appears to be linked to there being fewer trained psychiatrists, the marketing of improved psychiatric drugs and pressure from managed care companies that offer incentives for prescribing drugs over giving the more expensive psychotherapy.

"Psychiatrists get [paid] more for three 15-minute medication management visits than for one 45-minute psychotherapy visit," said Dr. Ramin Mojtabal, who co-led the research at Beth Israel Medical Center in New York, and who now works at Johns Hopkins Bloomberg School of Public Health in Baltimore.

"I was trained almost 30 years ago and received a lot of training in psychotherapy," said Dr. Christopher C. Colenda, a psychiatrist and Dean of Medicine at Texas A&M Health Science Center College of Medicine. "Thanks to the advances of managed care, psychotherapy was basically devalued from the perspective of psychiatry. ... A lot of the incentives for wanting to be in psychiatry were essentially removed by managed care."

The study examined data from the National Ambulatory Care Survey on visits to psychiatrists' offices for a 10-year period between 1996 and 2005, finding that the proportion of visits over 30 minutes long dropped from 44 percent in 1996-1997 to 28.9 percent in 2004-2005. Overall, out of 14,108 visits, only 34 percent provided psychotherapy to patients.

The number of psychiatrists who provided psychotherapy to all patients also fell, from 19.1 percent to 10.8 percent during the same 10-year period. Those who chose to continue psychotherapy had more patients who paid out-of-pocket for treatment than other doctors who gave less talk therapy.

For patients who require a combination of talk therapy and drug therapy, the trend towards medication-only can result in spotty treatment, in which the patient receives psychotherapy from a psychologist and drugs from a psychiatrist or general practitioner.

Physicians differ in their opinions over whether this is a problem.

"Whether it has any impact on the outcome of the disorder, we don't really know," said Dr. Mojtabal to Reuters. "I don't think necessarily that it is harmful. It might not be as efficient."

However, Dr. Eric Plakun, who leads an American Psychiatric Association committee working to restore interest in psychotherapy by psychiatrists, told Reuters that a shift away from psychotherapy began about 10 years ago when medical schools began to focus more on the biology of mental illness than on its psychology and behavior. "Either way, I'm worried about our patients [who] need the best help we can give them."

So is this the end of psychotherapy? Perhaps not, as it is effective and less expensive, and if you look deeper, there are signs that the use of talk therapy will continue and is, in fact, on the rise.

Since its benefits are well documented via behavior changes, emotional and mental habits, as well as through brain imaging studies, whether alone or combined with drug therapy, "the couch is far from dead," Dr. Plakun said. "The couch turns out to be an effective 21st century treatment."

Accreditation requirements for psychiatric residency programs are also putting more emphasis on talk therapy, so future medical professionals have the appropriate background to keep it alive.

Various forms are the recommended form of treatment for depression, post-traumatic stress disorder, bipolar disorder and other psychiatric illnesses.

In addition, visits to psychologists, social workers and other mental health counselors, who also provide talk therapy but are not medical doctors - and thus cannot prescribe drugs - were not included in this research.

Heather J. Chin can be reached at hchin@thebulletin.us.

©The Evening Bulletin 2008

HEALTH: Report: Prostate Cancer Screenings Pose Greater Risk Than Benefit For Older Men

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/07/2008

Recommendations by a federal task force are challenging routine preventive care practices for prostate cancer for the country's population of older men.

The guidelines, issued Monday by the U.S. Preventative Services Task Force and updated from its inconclusive stance in 2002, advise that such cancer screenings should not be performed on men aged 75 years and older. Reasons cited include a lack of strong evidence of overall benefit compared to the potential risks of screening.

In younger men, the efficacy of prostate-specific antigen (PSA) screenings remains unclear. Here, the task force advises early counseling about the risks and few benefits so men may elect not to be tested.

The study's results were published in the Aug. 5 issue of Annals of Internal Medicine. This is the first time a specific recommendation has been made on the issue.

According to Dr. Ned Calonge, chair of the 16-member task force, "the benefit of screening at this time is uncertain ... You have a chance that screening will help you live longer or better, and ... the chance that screening detection and treatment will harm you. At age 75, the chances are great that you'll have negative impacts from the screening."

Negative effects listed by the panel include psychological harm, impotency and incontinence, "additional medical visits, adverse effects of prostate biopsies, anxiety and overdiagnosis" - detection when treatment won't affect life expectancy. Some studies suggest that overdiagnosis alone can occur between 29 to 44 percent of the time.

Prostate cancer is the most common non-skin cancer in the United States and affects one out of every six men. Risk factors include family history of cancer or an African-American background.

According to the American Cancer Society, last year saw 218,890 men diagnosed with prostate cancer and about 27,050 deaths. It is the second-leading cancer killer, after lung tumors, among men. The overall mortality rate from the disease has dropped since it peaked in 1991.

Currently, one third of American men receive either PSA screenings, which test for protein blood levels, or a digital rectal exam, which identifies abnormal growth of the prostate gland. Detection enables doctors to monitor a patient whose condition is slow-growing, or to provide treatment. Some men die before their cancer even becomes an issue.

Still, the panel says their findings do not support definitive advice, and the new guidelines will not prevent a man from seeking screening and treatment for prostate cancer symptoms, such as frequent or painful urination or blood in the urine or semen.

"Larger, longer-term [clinical] studies are urgently needed," Dr. Calonge, who is also the chief medical officer for the Colorado Department of Public Health and Environment said. "We recommend that men concerned about prostate cancer talk with their health care providers to make a decision based on their individual risk factors and personal preference."

While the age limitation may be welcome for some, many doctors find the lack of strong new evidence against screening as not enough to discourage preventative care.

"The spirit of the recommendations is good, but the problem is they really do send the wrong message to older men who could have prostate cancer," said Dr. Leonard Gomella, chairman of the department of urology at Thomas Jefferson University's Kimmel Cancer Center. "This study falls short of the fact that there are older men over 75 who do need treatment."

Falling mortality rates and longer life spans around the world where PSA testing have been made available may support continued preventative care, as well.

"Men are living a lot longer these days. I play golf with 84-year-old guys who beat me all the time," Dr. E. David Crawford, a professor of surgery and radiation at the University of Colorado at Denver said to the Washington Post. "You have to individualize treatment."

"If it turns out that PSA screening and aggressive treatment saves lives, maybe all the harm that it has caused is worth it," Dr. Otis W. Brawley, chief medical officer at the American Cancer Society added. "We just don't know yet."

The PSA test was approved by the Food and Drug Administration in 1986 and has been utilized increasingly since the mid-1990s as stigmas faded, awareness grew, and screenings for other cancers such as breast and ovarian became more popular.

Heather J. Chin can be reached at hchin@thebulletin.us.

©The Evening Bulletin 2008

HEALTH: Deadly Risk - Sleep Apnea

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

08/06/2008

University of Wisconsin-Madison researchers have found that people with severe sleep apnea are up to three times more likely to die early from the disorder, and more so if the disorder remains untreated.

Sleep apnea is a common, chronic sleeping disorder in which a person has frequent pauses in breathing, ranging from a few seconds or even minutes, often accompanied by snoring and constant waking. Normal breathing typically begins again, but sleep deprivation night after night is dangerous.

"This is not a condition that kills you acutely. It is a condition that erodes your health over time," said Dr. Michael J. Twery, director of the National Center on Sleep Disorders Research.

Published in the international journal Sleep, the 18-year study of 1,522 men and women, ages 30 to 60, confirms smaller studies that have linked an increased risk of death with sleep-disordered breathing. Eighty people died during this time - about 19 percent of whom had severe sleep apnea and only 4 percent of whom had normal sleep patterns.

According to the report, heart disease and heart-related death was tied to 26 percent of all deaths among those with normal sleep patterns and 42 percent of deaths among those who had severe sleep apnea. Other risk factors for development of the disorder include excess weight, high blood pressure, family history of the condition, being male and use of alcohol or sedatives.

Participants in the study spent one night under observation at a sleep laboratory where they were screened for sleep apnea. Those diagnosed with the disorder were divided into groups according to the severity of their condition. Severity was measured by the average number of breathing pauses and sleep disruptions. Those with normal sleep patterns constituted the baseline group.

The findings implied that risk of death was reduced when participants underwent proper treatment, such as the use of continuous positive airway pressure (CPAP), which keeps airways open during sleep and prevents pauses during breathing. There has been debate over whether to use airway pressure to treat patients who are not sleepy during the daytime.

Overall, those experiencing sleep apnea had a risk of death 3.2 times higher than those at the baseline, even after adjusting for other risk factors such as age, sex and body mass index. For participants who had untreated (non-CPAP) sleep apnea, the risk of death was 3.8 times higher.

"I was surprised by how much the risks increased when we excluded people who reported treatment with CPAP," Dr. Terry Young, Ph.D., professor of epidemiology at the University of Wisconsin-Madison, said in a news release. "Our findings suggest - but cannot prove - that people diagnosed with sleep apnea should be treated, and if CPAP is the prescribed treatment, regular use may prevent premature death."

Researchers did note that 95 percent of the study's participants were white and most had both a stable income and health care.

"It is likely that our findings may underestimate the mortality risk of [sleep disordered breathing] in other ethnic groups or the lowest socioeconomic strata where there is poor awareness and access to health care," the researchers said.

The same issue of the journal Sleep included a separate 14-year study from Australia's Woolcock Institute for Medical Research, which came to a similar conclusion, finding that individuals with severe sleep apnea have six times the risk of death as those without the disorder.

However, the number of participants in each group was significantly skewed, weakening the conclusion's impact. The study followed 380 men and women between ages 40 and 65 in Western Australia, for up to 14 years. Out of 18 people with sleep apnea, 33 percent (6 people) died; of 285 people without sleep apnea, 7.7 percent (around 22 people) died.

The U.S. study was supported by the National Institutes of Health. The Australian study was supported by the Australian National Health and Medical Research Council.


Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

Some Antibiotics Could Damage Tendons, FDA Says

(for original article and comments, see www.thebulletin.us
As of this reprint, the statistics are under second review.)

By: Heather J. Chin, The Bulletin

07/14/2008

Some antibiotic drugs such as Bayer AG's Cipro and Avelox as well as Merck & Co. Inc's Noroxin will be required to have a stronger "black box" warning about the risk of tendonitis and ruptured tendons, according to new Food and Drug Administration regulations issued Tuesday.

In addition, an FDA-approved medication guide must be provided to individuals upon the filling of their prescriptions. Other drugs affected by the new requirements include Oscient Pharmaceuticals Corp.'s Factive, Depomed Inc.'s Proquin XR, and Ortho-McNeil's (a Johnson & Johnson subsidiary) Levaquin and Floxin.

Cipro and Levaquin, two leading drugs included in the warning, have other uses as well. Cipro is commonly used to treat urinary tract infections and is also effective against deadly bacteria, anthrax, being one of the drugs stockpiled by the government should a bio-attack occur. Levaquin is used to treat respiratory infections.

When sold by generic manufacturers, Cipro is referred to as ciprofloxacin and Floxin as ofloxacin. All of the drugs affected fall under a drug class known as fluoroquinolones.

Tendons are the tough, fibrous connective tissue joining muscles and bones. Also called sinew, they are essential to body movement and receive a lot of tension. Overuse can lead to inflammation and tendonitis, and excess pressure, some diseases and steroids can lead to snaps or ruptures. Such issues are normally thought of as sports injuries in young men or men in their mid-30s.

FDA studies indicate that the risk of tendon ruptures is estimated at about three to four times higher than normal rate (about one in 100,000) for those taking fluoroquinolones, notes Dr. Renata Albrecht, head of the FDA's division focusing on infectious microbes and transplant issues. Also, the risk is greater in patients ages 60 and older, particularly those who have had certain organ transplants or are using steroid therapy.

With this in mind, doctors are advised to restrict use of the drugs to confirmed bacterial conditions, and patients with tendon pain should immediately stop taking the drug, halt all exercise and call their doctor.
Patients who do experience a rupture may recover without surgery, but if surgery is needed to repair a torn tendon, full recovery may not be possible.

The regulation comes in the wake of a January 2008 lawsuit by consumer group Public Citizen, which had petitioned for the "black box" warnings two years ago and is still pushing for a warning letter to be sent to physicians describing the possible adverse reactions, such as tendon pain, that could be caused by the drugs.

"If the doctor is left out of the loop, it just doesn't make any sense," Sidney Wolfe, head of Public Citizen's Health Research Group said to Reuters UK.

Current labels for all the drugs involved already contain cautions about tendon problems, but Edward Cox, director of the FDA's antimicrobial products office, said, "The FDA believes that these labeling changes will better inform health care providers and patients about the risk."

Also, since the presence of several hundred "continued reports" of tendon-related problems indicated that these warnings were not reaching some doctors and patients, "additional steps are warranted to better manage the risk of tendon rupture," said Dr. Albrecht.

The specific number of reported cases were not available from the FDA, but Public Citizen's Mr. Wolfe lists government data as noting the numbers as 407 ruptures and 341 tendonitis cases through 2007 and 262 tendon ruptures, 258 tendonitis and 274 other tendon disorders through 2005.

Ortho-McNeil and their parent company Johnson & Johnson will add the new warning to both Levaquin and Floxin, as will Merck & Co. for its drug Noroxin, according to spokeswomen for the two companies.
Oscient released a statement saying it would review the issue and the remaining companies were not available for comment.

Heather J. Chin can be reached at hchin@thebulletin.us

Depression Meds May Trigger GI Tract Bleeding

(previously published here at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

07/11/2008

A class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) are associated with an increased risk of upper gastrointestinal (GI) tract bleeding, particularly when combined with painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), according to a study published in the July issue of Archives of General Psychiatry, a JAMA/Archives journal.

Many different medications fall into the category of SSRIs, which are widely prescribed to treat conditions such as depression and attention deficit hyperactivity disorder in both adults and adolescents and include drugs such as Prozac, Paxil, Effedra and Zoloft. NSAIDs are pain relievers, like ibuprofen and corticosteroids, used to treat things like arthritis, headaches, sports injuries, and fever.

In this study, two Madrid researchers at the Spanish agency for Medicines and Healthcare Products evaluated 1,321 patients with upper GI bleeding between 2001 and 2005 who had been referred to a specialist or hospital, and compared them with 10,000 control patients of the same age and sex who had no bleeding.

They found that patients with GI bleeding were more likely than patients in the control group to be taking SSRIs (5.3 percent versus 3 percent) or venlaxafine, an antidepressant commonly known as Effexor (1.1 percent versus 0.3 percent). This was an increased risk of 60 percent and almost 300 percent, respectively.

Dr. Francisco J. de Abajo, M.D., M.P.H., Ph.D. and Dr. Luis A. García-Rodríguez, M.D., M.Sc. consider their findings "important to determine whether [Effexor] also directly increases the risk of bleeding."

On the other hand, Dr. Abajo and Dr. García-Rodríguez's study also shows that taking acid-suppressing agents decreases the negative effects of the initial medications.

Since the early 1990s, case reports have noted a connection between SSRIs and upper gastrointestinal tract bleeding, other research has not, and none of these had studied what kind of effect the use of nonsteroidal anti-inflammatory drugs might have in conjunction with the other treatment.

Experts disagree on whether the study's evidence is conclusive or even significant. One argument is that "the risk of discontinuing antidepressants and getting depression and its consequences are much greater than [the consequences] of this drug," as Dr. Ewald Horwath, professor of psychiatry, epidemiology and public health at U. Miami's Miller School of Medicine said to the Washington Post.

On the other hand, another piece of advice would be to note if "you're taking [both] these medications. If you [are] along with other medications, keep it in mind and discuss with your physician," as Dr. Joseph White, associate professor of internal medicine at Texas A&M's College of Medicine said to the Washington Post.

Similarly, the authors wrote in their conclusion that "the wide use of this drug class requires research to provide more accurate risk estimates, to identify factors that may further increase the risk and, in particular, to determine whether using acid-suppressing agents may reduce the risk."

The study was funded by an unrestricted research grant from drug manufacturer AstraZeneca PLC for the validation of cases. Dr. García-Rodríguez has also received research grants from Pfizer Inc. and Novartis Pharmaceuticals Group.

Heather J. Chin can be reached at hchin@thebulletin.us

Non-Parent Care May Spur Infant Weight Gain

(previously published here at www.thebulletin.us)

By: Heather Chin, The Bulletin

07/08/2008

Aspects of modern family life, from stay-at-home parenting to childhood obesity, are increasingly residents of the public awareness, spurring conversation, influencing decisions, and permeating how we manage time in the workplace.

It may come as little surprise, then, that a new report in the Archives of Pediatric Medicine, one of the JAMA/Archives journals, has found a connection between child care by someone other than a parent and higher infant weight gain.

Nine-month-old infants regularly cared for by either a parent or a non-parent figure were observed during the study, conducted by researchers Juhee Kim, Sc.D., of the University of Illinois at Urbana-Champaign, and Karen E. Peterson of the Harvard School of Public Health, Boston, over the course of one year, during 2001 and 2002.

During regular home visits, the infants were weighed and measured and each respective primary caregiver provided information regarding type and intensity of child care, which included feeding practices.

The increase in weight came from what the researchers noted were higher rates of unfavorable feeding practices with the infants by non-parent regular caregivers.

"Infants who initiated child care at younger than three months were less likely to have been breastfed and were more likely to have received early introduction of solid foods than those in parental care," wrote the authors. Early introduction to solid foods is considered in the study to be a risk factor for weight gain, and both the National Institute of Child Health and Human Development and the American Academy of Family Physicians support breastfeeding for the first six months of care by women who don't have health problems.

Compared to infants who were cared for by parents, those in part-time care gained 174 grams (around 0.4 pounds) more weight, while infants cared for by relatives gained 162 grams (or around 0.35 pounds) more weight, were less likely to begin breastfeeding and also had a higher rate of early introduction to solid foods.

Out of 8,150 nine-month-old infants evaluated during home visits over the study period, a total of 55.3 percent of the infants evaluated received regular child care from a non-parent figure. Of these, half received full-time child care, 40.3 percent began care before 3 months of age, 39.3 percent began care between 3 and 5.9 months of age, and 20.7 percent began care at 6 months of age or older.

"Our study results provide new evidence that child care influences both infant feeding practices and risk of [becoming] overweight at least during infancy," the authors wrote in their conclusion.

According to background info in the study, almost 75 percent of infants in their first year of life receive some form of child care by individuals not their parents. In addition, the authors describe how child care is often associated with positive cognitive and language development, as well as strength in the social, emotional and academic realms.

As the first available study into the relationship between child care, feeding practices and infants' weight, both Dr. Kim and Dr. Peterson consider their findings to be simply a first step in understanding at least some of the factors that may lead up to a child being overweight. "Child care factors were associated with unfavorable infant feeding practices and more weight gain during the first year of life," they said, "[and] the effects ... warrant longer follow-up to determine subsequent risk [of such increased weight]."

Heather Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

Pollution Triggers Children's Allergies, Diseases

(previously published here at www.thebulletin.us)

By: Heather Chin, The Bulletin

07/08/2008

Living near roads that are heavily trafficked and polluted increases a child's risk of developing physician-diagnosed asthma, allergies and atopic diseases (chronic skin diseases) by more than 50 percent, a new study finds.

The 17-month study by researchers from Germany's Center for Environment and Health at the Institute of Epidemiology was based on the idea, as described by the lead author Joachim Heinrich, Ph.D, that "[children] living very close to a major road are likely to be exposed not only to a higher amount of traffic-derived particles and gases but also to a more freshly emitted aerosols which may be more toxic."

The study's results were published in the second June 2008 issue of the American Thoracic Society's American Journal of Respiratory and Critical Medicine. In his summary, Dr. Heinrich considers them to "provide strong evidence for the adverse effects of traffic-related air pollutants on atopic diseases as well as on allergic sensitization."

This is the first study to report an association between allergic sensitization and pollution levels. Previous studies done in the United States found links between the two, but took into account various socioeconomic, environmental and behavioral factors that are also associated with life in urban areas, making a causal relationship between pollutant exposure and allergic risk impossible.

Socioeconomic variables in U.S. studies over the past two years include the effect of diesel exhaust particles on airborne allergenic particles, environmental variables include ozone levels, and behavioral factors include recreational time spent indoors instead of outdoors.

Researchers for this study, however, say that older European cities like Munich, where the study was conducted, have roads and buildings that are established in a way that makes it possible to eliminate a correlation with economic advantages or disadvantages.

Approximately 2,900 four-year-olds and over 3,000 six-year-olds who had been born and were enrolled in school in the metropolitan area of Munich, Germany, were examined over the course of the study. The children's long-term exposure to traffic pollutants were calculated as a function of the distance from their houses to the major roads at birth and at ages two, three and six. Control groups were used to account for individual circumstances such as pet ownership, pet allergies and number of siblings.

Parents filled out questionnaires about their child[ren]'s respiratory diagnoses and symptoms while children were evaluated for asthma, sneezing, wheezing and eczema. At age six, all of the children were tested for food allergies. In addition, the air in each of 40 identified points near high traffic areas was tested for smog, soot and other particulate matter, as well as nitrogen oxide (NO2) once per season between March 1999 and July 2000.

On top of the 50 percent greater risk of allergic sensitization, the results found strong positive links between the distance of the nearest road and diseases such as hay fever, asthmatic bronchitis, eczema and allergic sensitizations. Also, children who lived within half a block (50 meters/164 feet) to a busy street had the highest probability of getting symptoms, compared to children living further away.

Heather Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

FDA Approves A New Insulin Pump

(previously published at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

07/03/2008

At the same time that a wireless insulin pump for diabetics has been approved for marketing and public use by the U.S. Food and Drug Administration (FDA), its regulators are reconsidering the standards they use to approve diabetes medications.

The FDA began hearing from a panel of outside diabetes experts, cardiologists and statisticians on Tuesday as to whether the agency should require pharmaceutical companies to prove, through extensive long-term clinical research studies, that their drugs reduce heart problems and do not increase risk of death in order to gain FDA approval.

Diabetes is a disease where the body either does not produce or properly use insulin, a hormone that converts food into energy. Prescription drugs used to treat type 2 diabetes - the most common form, where a person's body either produces too little insulin or rejects insulin - are currently evaluated on the basis of whether they are proven to control blood-sugar levels.

The wireless insulin pump that has been approved is known as the OneTouch Ping glucose management system and is produced by Animas Corp., a medical device company from West Chester, that is a subsidiary of Johnson & Johnson Corp. in New Brunswick, N.J. It makes it easier for individuals with diabetes to calculate and inject themselves with the proper dose of insulin.

This reconsideration of regulatory standards is the result of questions that arose last year after an analysis of a popular diabetes drug, Avandia, showed that although taking it lowered blood-sugar levels, its use also increased the risk of heart attack in individuals.

FDA research into the issue yielded no actionable results, and additional trials by Avandia's manufacturer, GlaxoSmithKline, which has operations in the Philadelphia area, will likely not be ready until 2014.

The panel's opinions may influence and affect that approval of both new diabetes drugs and those that are already on the market.

However, there are some scientist even from within the FDA, who are skeptical of the value of tying risk of a side effect (heart attack) to the approval and availability of a drug whose target goal is to treat [low blood sugar and] diabetes.

Still, consumer advocates, lawmakers and diabetes organizations express concern over the risk of possible side effects.


Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

New Vaccines Approved For Kids

(previously published at www.thebulletin.us)

By: Heather J. Chin, The Bulletin

06/30/2008

Pentacel and Kinrix, two new combination vaccines that immunize infants and children against multiple diseases with fewer injections, received federal approval this week and will be available for distribution to U.S. health care providers by this summer.

Kinrix is produced by GlaxoSmithKline, a UK company with operations and research and development sites throughout Philadelphia, Upper Merion and King of Prussia. Likewise, Pentacel has a Pennsylvania connection, as it is the product of Sanofi Pasteur of Swiftwater. It is a division of Sanofi Aventis Group, a French company that creates vaccines protecting against infectious diseases.

The two vaccines were approved by the Advisory Committee on Immunization Practices, which voted to recommend adding both combination vaccines to the federal government's Vaccines for Children program. The program which provides free vaccinations for all children, regardless of ability to pay.

For the 6 weeks to 4-5 year (before the fifth birthday) age group, the FDA has approved Pentacel, a five-in-one vaccine manufactured by Sanofi Aventis, to protect infants and children against diptheria, tetanus, pertussis (also known as whooping cough), polio and Haemophilius influenzae type b (Hib).

It is administered as a four-dose series, one-a-time at 2, 4, 6 and 15-18 months of age. It is the first four-dose combination vaccine licensed in the U.S. that includes both poliovirus (IPV) and Hib vaccine antigens.

For children 4 to 6 years of age, GlaxoSmithKline will release Kinrix, a four-in-one booster vaccine that uses only one shot and is geared for use to protect against diptheria, tetanus, pertussis and polio. Kinrix is recommended for use by children who have already taken Infanrix or Pediarix vaccines.

Infanrix covers DPT, diphtheria, tetanus, and pertussis (whooping cough).
Pediarix is a multiple vaccine that covers DPT, hepatitis B and polio, and has had over 30 million doses used in younger children since 2003.

Clinical studies into Pentacel and Phase III trials into the safety of Kinrix have shown that the new combination vaccines offer similar safety benefits as previous vaccines.

Both vaccines seek to remedy the problem of multiple doctor visits where young children, their parents and their doctor must deal with the stress of frequent needle jabbing. The U.S. Centers for Disease Control and Prevention (CDC) currently recommend up to 23 single shots by the time a child reaches 18 months of age.

Using combination vaccines "reduces the number of shots by 6 shots in the first year of life, with the same degree of efficacy and no[ne or fewer] side effects," said Dr. Gary Emmett, professor of pediatrics at Jefferson University Hospital and member of the Board of Health in the city of Philadelphia.

Fewer shots can also have a positive effect on the child's health.

"When I started practicing, we gave DTP, which had almost 200 separate antigens in it, " said Dr. Emmett. "Now we give DTaP, which is more refined and has less than 30 antigens, so even though... the [earlier ones] were effective, they gave more side effects. Now we have less sore arms, less fevers, making the [children and the] pediatricians happy."

Combination vaccines can also help to fulfill both school and CDC immunization requirements, says Jennifer Armstrong, a GlaxoSmithKline spokewoman, while also creating less need to experience painful finger or arm pricks, especially when young children are involved.

"Four- to six-year-olds are a particularly challenging group," said Ms. Armstrong. "They are old enough to [know what's coming and] say no right off the bat."

Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008

UPenn Med School Partners With Pfizer For Clinical R&D

(previously published at thebulletin.us)

By: Heather J. Chin, The Bulletin

06/26/2008

Philadelphia - The University of Pennsylvania School of Medicine has entered into a three-year partnership with pharmaceutical research giant, Pfizer Inc., to collaborate in the areas of scientific research, clinical development and clinical care and policy.

Pfizer will pay Penn $15 million over the course of the three years, during which time project proposals will be solicited and reviewed by a committee with members representing both the industry and academia.

Projects chosen will address several therapeutic areas of basic and translational research, initially focusing on the neurosciences and oncology before possibly expanding to other areas of specialization.

According to the National Institutes of Health's Roadmap of Re-engineering the Clinical Research Enterprise, basic research is the phase where scientists study disease at a molecular and cellular level. Translational research is when these basic tools are applied towards patient treatment, allowing doctors to make observations about disease progression that can be used for further clinical research.

Another aim of the partnership is to develop an initiative to improve the management of cardiovascular risk and patient adherence to treatment, with the goal of using those results to create similar programs at other academic centers.

Patients for the pilot program will be those currently served by the University of Pennsylvania's Health System.

In the realm of clinical policy, the partnership will also enable the University and Pfizer to go over how health-care policy is currently applied in patient treatment and care.

"We are excited to work wit Pfizer in a manner that spans the health care continuum, from pre-clinical research through patient care, in a way that can serve as a model for optimal interactions between industry and academia," said Arthur H. Rubenstein, MBBCh, Executive Vice President of the University of Pennsylvania for the Health System, and Dean of the School of Medicine, in a Pfizer press release.

Since 1985, Pfizer and the UPenn's School of Medicine have had an ongoing relationship in the area of clinical studies, with Pfizer sponsoring 130 studies at Penn across 10 therapeutic areas, including oncology, psychiatry and infectious disease.

Heather J. Chin can be reached at hchin@thebulletin.us

©The Evening Bulletin 2008