Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD. Although the mechanism of action is unknown, INTUNIV is thought to directly engage receptors found in the prefrontal cortex an area of the brain that has been linked in preclinical research to ADHD. Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.

“Shire is proud to introduce INTUNIV, providing clinicians, patients, and their families with a novel ADHD treatment option,” said Mike Cola, President of Shire Specialty Pharmaceuticals. “This is a complex disorder in which patients may present with multiple symptoms and behaviors that can be disruptive. INTUNIV expands the Shire ADHD portfolio with a nonscheduled medication, allowing clinicians to optimize their overall approach toward managing ADHD and may help provide symptom control for children and teens with ADHD who often have difficulty responding appropriately to everyday situations and challenges.”

Once-daily INTUNIV is expected to be available in US pharmacies in November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg). INTUNIV will be marketed in the United States by the existing Shire ADHD sales team of nearly 600 representatives. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

“Everyday situations and challenges may be difficult for children and adolescents with ADHD as it is a disruptive disorder that includes symptoms and behaviors such as being easily distracted, always on the go, interrupting others, arguing with adults, or temper outbursts,” said Frank A. Lopez, MD, a neurodevelopmental pediatrician in private practice at Children’s Developmental Center in Winter Park, Florida. “In clinical trials, INTUNIV, a selective alpha-2A receptor agonist, significantly reduced ADHD symptoms across a full day as measured by parents at 6 pm, 8 pm, and 6 am the next morning. This is important because children with ADHD require symptom control at home, school, and during after school activities.”

The introduction of INTUNIV is consistent with the strategy of Shire to expand and diversify its ADHD portfolio, which now consists of four ADHD treatment options of scheduled and nonscheduled medicines in the United States and two ADHD medicines available outside the United States.

INTUNIV Demonstrated Significant Reduction in ADHD Symptoms

The efficacy of INTUNIV in the treatment of ADHD was established in two, similarly designed, placebo-controlled clinical trials in children and adolescents aged 6 to 17 years who met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV(R)) criteria for ADHD. Statistically significant improvements were reported by investigators, parents, and teachers.

The first pivotal trial was a phase III, double-blind, parallel-group trial, in which investigators randomized 345 children aged 6 to 17 years to either a placebo or a fixed 2-mg, 3-mg, or 4-mg dose of INTUNIV given once daily during an eight-week period. The second pivotal trial was a phase III, double-blind, parallel-group trial, in which investigators randomized 324 children aged 6 to 17 years to either a placebo or a fixed 1-mg, 2-mg, 3-mg, or 4-mg dose of INTUNIV given once daily during a nine-week period, with the 1 mg assigned only to patients weighing less than 50 kg (110 lbs).

In both trials, doses were increased in increments of 1 mg per week, and investigators evaluated participants’ signs and symptoms of ADHD on a once-weekly basis using the clinician administered and scored ADHD Rating Scale-IV (ADHD-RS-IV), a scale frequently used in ADHD clinical trials that assesses hyperactive, impulsive, and inattentive symptoms. The primary outcome was the change in total ADHD-RS-IV scores from baseline to end point in both studies.

Both trials demonstrated statistically significant improvements in ADHD-RS-IV scores in patients taking INTUNIV beginning one to two weeks after patients began receiving once-daily doses of INTUNIV. In the first pivotal trial, the mean reduction in ADHD-RS-IV total scores at end point were -16.7 for INTUNIV compared to -8.9 for placebo (P Continue reading →

UV light-enhanced tooth bleaching is not only a con, but is dangerous to your eyes and skin, says a Royal Society of Chemistry journal.

The light treatment gives absolutely no benefit over bleaching without UV, and damages skin and eyes up to four times as much as sunbathing, reports a study in Photochemical & Photobiological Sciences.

Those looking to match Tom Cruise’s glittering pearly-whites would be better off ignoring claims of better bleaching with UV light treatment.

The treatment is at least as damaging to skin and eyes as sunbathing in Hyde Park for a midsummer’s afternoon – one lamp actually gave four times that level of radiation exposure.

And as with sunbathing, fair-skinned or light-sensitive people are at even greater risk, said lead author Ellen Bruzell of the Nordic Institute of Dental Materials.

Bruzell also found that bleaching damaged teeth. She saw more exposed grooves on the enamel surface of bleached teeth than on unbleached teeth. These grooves make the teeth more vulnerable to mechanical stress.

Tooth bleaching is one of the most popular cosmetic dental treatments available. It uses a bleaching agent – usually hydrogen peroxide -to remove stains such as those from red wine, tea and coffee, and smoking.

UV light is claimed to further activate the oxidation process, improving bleaching efficiency. The authors of this Photochemical & Photobiological Sciences article say there is very little substantive evidence to support this claim, and their new study finds no benefit to using UV light.

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One of the best ways to encourage an individual to get screened for colorectal cancer is to use a personalized approach, according to researchers at Jefferson Medical College in Philadelphia. A new study shows that simple, personalized interventions that guide recipients through the screening process can significantly improve colorectal cancer screening rates in primary care practices.

Ronald Myers, Ph.D., professor of medical oncology at Jefferson Medical College of Thomas Jefferson University and his co-workers divided 1,546 at-risk primary care patients who were not up-to-date on colon cancer screening into four groups. They randomly assigned patients to receive one of the following: usual care (control); mailed information, screening materials and a mailed reminder (group one); mailed information with messages addressing personal concerns about screening, screening materials, and a mailed reminder (group two); or mailed information with personal messages, screening materials, plus mail and telephone reminders (group three).

The team, reporting online September 24, 2007 in the journal CANCER, found that compared to usual care controls, all of the personalized approaches made a difference. Two years after the study began, screening rates were higher in each intervention group compared to the control group. Only 33 percent of individuals in the control group were screened, compared to 48 percent in group three, 46 percent in group two and 44 percent in group one.

“We found that we can get a substantial increase in screening by taking a personalized approach in which the at-risk population is identified and then offered screening and information,” Dr. Myers says. “More than 40 percent responded and were screened. By adding in the personal messages that addressed personal barriers to screening, such as concerns about test inconvenience and discomfort, we were able to see additional, modest improvements.”

According to Dr. Myers, the number of individuals going for colon cancer screening in primary care practices has traditionally been low. His team and others have been trying to find new ways to raise screening rates. But it has been difficult. “The key to addressing this important public health problem is to apply a relatively simple, low-cost approach that not only increases screening use, but is also cost-effective,” Dr. Myers says. His team showed “the potential impact that can be achieved when such an intervention strategy can be delivered to patients in primary care practice settings. In fact, if personalized interventions were delivered as an ancillary service to primary practices, we could increase screening rates substantially, and as a result, reduce the burden of colorectal cancer dramatically.”

Colorectal cancer is the third most common cancer and third leading cause of cancer death in this country. Yet, when found early, the disease can be prevented or easily treated. Generally, recommendations include fecal blood testing every one to two years after age 50, a flexible sigmoidoscopy every five years and a colonoscopy every ten years.

Contact:
Steve Benowitz or Jackie Kozloski

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Nine out of ten patients who discontinued their overactive bladder (OAB) medication said it was because it didn’t work as expected or they couldn’t tolerate it, according to research in the May issue of the urology journal BJUI.

US researchers also discovered that smokers, men with enlarged prostates and people with bladder infections are also significantly more likely to stop taking prescription drugs for bladder problems.

The team surveyed 6,577 adults who said in a National Family Opinion survey that they had been prescribed medication for OAB in the last 12 months and 82% responded.

They found that patients who had abandoned their medication were much more likely to be bothered by OAB symptoms than those who had persisted and more likely to have had a diagnosis for a condition such as OAB or incontinence.

A quarter of the 5,392 who responded had discontinued one or more of their OAB drugs in the last year, with the majority giving multiple reasons. Just under half (46%) said the medication didn’t work as expected, 23% learnt to get by without medication and 21% reported side effects. Other reasons included cost, change of insurance status, not wanting to use medication, advice from healthcare professionals and health improvements. A quarter said they had switched to a new medication.

“Encouraging people with long-term health conditions to persist with medication is common and problematic” says Professor Linda Brubaker from Loyola University, Chicago, who co-authored the paper with urology colleagues from across the USA.

“Recent database studies suggest that the number of OAB patients who stop taking their medication is much higher than clinical trials would suggest.

“It is important to identify why people stop taking their medication as persistence with medication is generally associated with positive health outcomes and reductions in healthcare resource use and costs.”

Key findings of the study included:
Bothersome OAB symptoms were reported more frequently by patients who had discontinued their medication: 10% more were “quite a bit more” bothered about needing to urinate at night, 13% more with urgency, 9% more with incontinence and 11% more with frequency.
More patients in the discontinued medication group had a medical diagnosis of OAB (10% more than the group who persisted), incontinence (8% more), bladder infection (6% more) and urinary retention (4% more).
There were no statistically significant differences in sex, age or race, household income, health insurance and prescription insurance between the two groups and relatively minor differences when it came to beliefs about OAB, including what was normal and how it could be treated.
A third of the people who had discontinued gave one reason for stopping, a third gave two reasons and a third gave three reasons.

A second paper in the May issue of BJUI focuses on the results of a six-month follow-up on the patients who were still taking their medication at the time of the above study, based on an 84% response rate.

This showed that 66% were still taking their medication, 18% had discontinued and 17% had switched medication in the intervening six months.

Researchers found that a number of factors increased the chances of patients discontinuing their OAB medication, including:
Being a current smoker (up 80%)
Having an enlarged prostate (up 74%) or a bladder infection (up 54%).
Believing that bladder medication caused severe side effects (up 111%) or not knowing whether it did or not (up 76%).
Being bothered “quite a bit more” by a sudden urge to urinate with little or no warning (up 54%).

However, being on multiple prescriptions or having had an episode of incontinence in the last week increased the odds of compliance.

“To our knowledge this is the first study to ask patients why they discontinued their OAB medication” says Professor Brubaker. “We believe that our findings point to the need for healthcare providers to foster realistic expectations about how effective OAB treatment will be and about any side effects.

“We also believe that healthcare providers should discuss lifestyle changes, such as smoking cessation, urgency control strategies and pelvic floor muscle training with OAB patients. Research has shown that providing behavioural advice as well as drugs to patients with OAB can improve both symptoms and satisfaction with treatment.”

Notes:
Paper 1) Patient-reported reasons for discontinuing overactive bladder medication. Benner et al. BJUI.105, pp 1276-1282. (May 2010). DOI: 10.1111/j.1464-410X.2009.09036.x

Paper 2) Predictors of discontinuing overactive bladder medications. Brubaker et al. BJUI. 105, 1283-1290. (May 2010). DOI: 10.1111/j.1464-410X.2009.09035.x

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Propelled by advances
in molecular biology, the treatment of colorectal cancer is on the
verge of dramatic change and a promising future as innovative
vaccines will replace chemotherapy. According to a new report from
Kalorama Information, “Cancer Vaccines: Market Forecasts, New
Developments and Pipeline Analysis,” this market, lead by OncoVAX, is
poised for unprecedented growth, creating countless opportunities for
market participants.

More than 1.2 million cases of colon cancer are diagnosed worldwide
each year with more than 529,000 deaths, which displays a considerable
medical need. In the United States colorectal cancer is the second
most common cause of cancer, accounting for approximately 50,000
deaths and about 20% of all deaths from cancer.

Most new cases of colon cancer require surgery for removal of tumors
followed by chemotherapy to prevent recurrences. A vaccine that
eliminates cancer recurrences without the side effects and with a
better survival rate will be very beneficial to patients after
colorectal cancer surgery.

Past attempts to find cancer vaccines failed because scientists had a
crude understanding of the molecular mechanics of the immune system
and cancer cells. But patients will soon benefit from advances in DNA
profiling and the emerging field of pharmacogenomics.

“Pharmacogenomics will lead to tailored treatments based on a tumor’s
specific genetic profile, which will allow physicians to treat tumors
based on their genetic make-up rather than their location,” notes
Kalorama Information analyst Melissa Elder. “One such tailored
treatment is OncoVAX offered by Vaccinogen to treat colorectal
cancer.”

Several colorectal cancer vaccines are in development, including
TroVAX, Avicine and Oncophage in phase II, but the closest to market
is OncoVAX. Currently in Phase III development, OncoVAX is an
active-specific immunotherapeutic for the post-surgical treatment of
patients diagnosed with Stage II colon cancer. It is prepared using
the patient’s own surgically removed tumor, which is enzymatically
treated, frozen, and irradiated to render the cells non-tumorogenic.

Kalorama Information’s report “Cancer Vaccines: Market Forecasts, New
Developments and Pipeline Analysis,” focuses on both preventative and
therapeutic cancer vaccines in development. A market overview, cancer
statistics, market estimates and forecasts for 2008-2012 are
included, as well as discussions of current issues and trends
affecting the industry. For further information click here.

About Kalorama Information

Kalorama Information supplies the latest in independent market
research in the life sciences, as well as a full range of custom
research services. We routinely assist the media with healthcare
topics.

Kalorama Information Continue reading →

Corgentech Inc (Nasdaq: CGTK), and Bristol-Myers Squibb Company (NYSE: BMY) announced top-line results from PREVENT IV, a
Phase 3 clinical trial evaluating the use of edifoligide (E2F Decoy), an investigational product, to prevent vein graft
failure following coronary artery bypass graft (CABG) surgery. Treatment with E2F Decoy failed to meet the trial’s primary
and secondary endpoints. E2F Decoy was generally well tolerated in the 3,014-patient trial. Corgentech will host a webcast
conference call today at 8:30 a.m. EST to review the clinical data announced today.

The complete data from the PREVENT IV trial will be presented in future scientific publications and presentations by the
study’s clinical investigators. Corgentech and Bristol-Myers Squibb have an agreement to jointly develop and commercialize
Corgentech’s E2F Decoy. Bristol-Myers Squibb has advised Corgentech that it will be terminating the collaboration consistent
with the agreement.

“We will conclude our Phase 1 trial in AV grafts and do not plan to develop E2F Decoy further. We are grateful to
Bristol-Myers Squibb for the support that they have provided to Corgentech and to this program and have enjoyed working
closely with them on this collaboration,” said John McLaughlin, president and chief executive officer of Corgentech. “We are
fortunate to have a deep pipeline of products to choose from and have the ability to generate new product candidates very
rapidly. Corgentech’s NF-kappaB (NFkB) Decoy, which was generated in just five months, will enter the clinic shortly for
eczema, and we plan to select our next clinical candidate in the second half of this year.”

PREVENT IV Trial Design

This multi-center, placebo-controlled, double-blind, randomized Phase 3 study was conducted in collaboration with The Society
of Thoracic Surgeons and the Duke Clinical Research Institute, an academic research organization. The Phase 3 clinical trial
involved 3,014 patients undergoing CABG surgery at over 100 centers, and its primary endpoint was the percent reduction in
the incidence of graft failure between the E2F Decoy treated and placebo groups. Graft failure was defined in the trial as
blockage of the graft of 75 percent or greater as measured by quantitative coronary angiography at 12 months. Safety was
assessed by monitoring adverse events, post-operative complications and laboratory abnormalities.

About Corgentech

Corgentech is a biopharmaceutical company engaged in the discovery, development and commercialization of a new class of
therapeutics called transcription factor decoys, or TF Decoys. We are creating a pipeline of novel therapeutics based on our
proprietary TF Decoy technology, focused initially on the treatment of inflammatory diseases and cancer. For more information
on the company and its technologies, visit corgentech.

About Bristol-Myers Squibb Company

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and
enhance human life.

Conference Call Details

Corgentech will conduct a webcast conference call with the investment community at 8:30 a.m. EST, today, March 30, 2005, to
discuss the Phase 3 results. The call will be available via live audio broadcast over the Internet on the Corgentech website
at corgentech from the Investor Information page. For
those unable to participate via the internet, a 24-hour replay will be available for seven days after the call by dialing
800-642-1687 (international dial: 706-645-9291) and giving the following pass code: 5202192.

For more information, contact: Corgentech Inc. – Jennifer Cook Williams, Investor Relations, 650-624-9600,
investorscorgentech; or Bristol-Myers Squibb Company – Robert Hutchison, Corporate and Business Communications,
609-252-3901, robert.hutchisonbms, John Elicker, Investor Relations, 212-546-3774, john.elickerbms

Corgentech Forward-Looking Statements

This press release contains forward-looking statements, including without limitation all statements related to our clinical
trials and progress with developing product candidates. Words such as “believes,” “anticipates,” “plans,” “expects,”
“intend,” “will,” “slated,” “goal” and similar expressions are intended to identify forward-looking statements. These
forward-looking statements are based upon our current expectations. Our actual results and the timing of events could differ
materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which
include, without limitation, risks related to the development of TF Decoys, progress, timing and results of our clinical
trials, intellectual property matters, difficulties or delays in obtaining regulatory approval, manufacturing our lead
product candidate, competition from other pharmaceutical or biotechnology companies, our ability to obtain additional
financing to support its operations and other risks detailed in relevant filings with the Securities and Exchange Commission,
including our Annual Report on Form 10-K for the year ended December 31, 2004. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements
are qualified in their entirety by this cautionary statement, and Corgentech undertakes no obligation to revise or update any
forward-looking statements to reflect events or circumstances after the date hereof.

bms/news/press/data/fg_press_release_5492.html Continue reading →

The Complementary and Natural Healthcare Council (CNHC) opens its register to reflexology practitioners which means that members of the public will be able to choose their registered reflexologist in the knowledge that they meet national standards of conduct and competence.

Launched with government backing through the Department of Health who recently said, “if patients choose to use complementary or alternative therapy, the Government’s advice is to choose a practitioner registered with a reputable voluntary registration body such as the CNHC”, the register opened in January 2009. Members of the public who use complementary healthcare will for the first time be able to verify that their reflexologist is registered with the first UK wide regulator.

The voluntary register will open over the course of this year to a wide range of complementary and natural healthcare practitioners. Reflexology is the fourth discipline for which the register has opened this year, joining massage therapy, nutritional therapy and aromatherapy.

By registering with the CNHC, reflexology practitioners will be seen as meeting the ‘gold standard’ within their field and will be entitled to display the quality mark which is given to practitioners upon registration.

Maggie Dunn, CEO of the CNHC explained: “We are delighted that CNHC is today opening its register to reflexology practitioners. Members of the public who use or are interested in using reflexology will be able to check whether the practitioner they’re seeing is registered with the CNHC.”

Continues Maggie, “Public safety is paramount and it is vital that practitioners meet the CNHC minimum standards of qualification and/or experience and in addition, they are signed up to a rigorous code of conduct. Not only will people looking for a reflexologist have peace of mind but practitioners too will benefit through increased public confidence”

Reflexology is the physical act of applying pressure to the feet and hands using a variety of hand techniques. It is based on a system of zones and reflex areas that reflect an image of the body on the feet and hands. Reflexology practitioners believe that such work may bring about a physical change to the body, or improve general health.

Throughout the rest of 2009, the Register will be opened to further disciplines, as they become ready and wish to register, and include: Yoga therapy, Shiatsu, Alexander technique, Bowen technique, Cranial therapy, Naturopathy and Reiki.

For further information about registration, visit cnhc

Notes

The Complementary and Natural Healthcare Council (CNHC) was established as a voluntary register in April 2008 with the purpose of protecting the public by means of a voluntary register for complementary and natural healthcare practitioners.

The CNHC’s function is:

To establish and maintain a voluntary register of complementary healthcare practitioners in the UK who meet its standards of competence and practice

To make the Register of practitioners available to the general public and to educate them about the CNHC quality mark as a quality standard

To operate a robust process for handling complaints about registered practitioners

To work with professional bodies in the complementary healthcare field to further develop and improve standards of professional practice

The Register has been launched with government backing through the Department of Health.

Source
Complementary and Natural Healthcare Council Continue reading →

The Dermatology Nurses’ Association (DNA) joined the Longwood Symphony Orchestra (LSO) and other performers last month for a benefit concert to raise funds and public awareness about melanoma. The event also honored individuals and families touched by the deadly skin disease.

The October 26 event, held at Symphony Hall in Boston, MA, raised $30,000 for the Children’s Melanoma Prevention Foundation and the Melanoma Education Foundation.

The concert was one of several benefit events sponsored each year through the orchestra’s “Healing Art of Music” program which supports health-related nonprofit organizations. Over 2,000 people attended, including health care providers, children from 10 Boston area schools, skin cancer patients and their families, as well as the general public. The concert was preceded by an educational health fair featuring exhibits and free product samples.

Two of DNA’s most active sun protection advocates, Maryellen Maguire-Eisen, MSN, RN, and Karrie Fairbrother, BSN, CDE, DNC, addressed the musicians, singers, and audience during the dress rehearsal and concert. Maguire-Eisen, executive director/founder of the Children’s Melanoma Prevention Foundation, and Fairbrother, DNA’s president elect, stressed the importance of collaboration and public education to prevent skin cancer. Fairbrother also shared her personal story of loss; her husband died from malignant melanoma 18 years ago.

The LSO was joined by Chorus Boston, the Kokugikan Sumida Choral Society of Japan and New World Chorale as well as several soloists. The performers were led by Conductor Shunji Aratani.

The event was sponsored by Roche Bros, Sullivan Tire, Sullivan Toyota, Graceway Pharmaceuticals, Neutrogena Corporation, DNA, Dusa Pharmaceuticals, Boston University Section of Dermatopathology, Candella Laser, Medical Laser Technologies and Coolibar Sun Protection.

In addition to charitable events like the concert, DNA also sponsors many professional education events for nurses and skin care providers as well as broader initiatives to help increase public awareness about skin cancer and sun protection. Maguire-Eisen and Fairbrother, as well as other DNA members, speak nationally on effective sun protection methods and the risks of melanoma, which is one of the most common and deadly forms of the disease.

The Longwood Symphony Orchestra (LSO) was established in 1982 by members of the Harvard Medical School community, according to the organization’s Web site. The LSO provides opportunities for advanced amateur musicians while supporting various nonprofit organizations through public performances. Since 1991, the orchestra has helped raise over $700,000 for the medically underserved by performing concerts to benefit medical charities in the greater Boston area. The orchestra’s 125 members are also members of Boston’s medical community.

More information

Longwood Symphony Orchestra
Children’s Melanoma Prevention Foundation
Melanoma Education Foundation

The Dermatology Nurses’ Association (DNA) is a professional nursing organization comprised of a diverse group of individuals committed to quality care through sharing knowledge and expertise. DNA’s core purpose is to promote excellence in dermatologic care.

Dermatology Nurses Association Continue reading →

When treating cancer, it is an advantage to know the rate of growth of the cancer tumour. The standard method currently used to determine tumour growth, however, is erroneous. This is the conclusion of scientists at the University of Gothenburg, Sweden, who have developed a new model.

The principal reason that patients die of cancer is the spread of cancer cells through the body to form new tumours known as metastases. These metastases are initially so small that they cannot be detected by modern diagnostic methods. The healthcare system must therefore, when treatment begins, rely on mathematical models to calculate the growth of a tumour.

The standard method for describing tumour growth uses a parameter known as “doubling time” (DT), which specifies the time it takes for a tumour to double in volume. Scientists at the University of Gothenburg have now shown that this widely applied calculation method is erroneous.

Scientist Esmaeil Mehrara and his colleagues at the Department of Radiation Physics, University of Gothenburg, have developed a new method that calculates the rate of tumour growth more accurately. The new method uses a parameter known as the specific growth rate (SGR), which measures the percentage growth of the tumour per day.

The new method improves the possibility of determining the effects of various treatment alternatives.

“The standard method used to determine the effect of therapy does not take the rate of tumour growth into account, while our new model does. This means that we can measure more accurately even small effects of treatment”, says Esmaeil Mehrara.

It is hoped that the new method using SGR will be valuable in determining whether a treatment is having an effect or not in a particular patient. This means that the best treatment for a patient can be found more rapidly than is the case today.

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Spirometry testing is a widely accepted and encouraged diagnostic method for chronic obstructive pulmonary disease (COPD), but new research shows that it is not used nearly enough. The study appears in the August issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP) and reports that only one-third of patients with a COPD diagnosis ever received spirometry testing.

“Without proper testing, both underdiagnosis and misdiagnosis may occur, which can lead to improper therapies being prescribed,” said lead author MeiLan Han, MD, MS, University of Michigan, Division of Pulmonary and Critical Care Medicine. “This study shows that we have a lot of work ahead of us in terms of raising awareness among both patients and physicians.”

Along with colleagues from Johns Hopkins University, the University of Washington, and the National Committee for Quality Assurance, Dr. Han identified patients with newly diagnosed COPD by data collected from five health plans. The study examined patients aged 40 years and older, and determined if patients with a new diagnosis of COPD had received spirometry in the preceeding 720 days. Of the 5,039 eligible patients identified, only 32% were found to have received spirometry testing. Furthermore, only half of those patients received follow-up bronchodilator testing to confirm their diagnosis.

“In order to distinguish COPD from other diseases, such as asthma, spirometry must be measured both before and after administration of medication that dilates the airways,” Dr. Han explained. “As such, if COPD is suspected, initial spirometric testing should include bronchodilator testing too, in order for that patient to receive a truly diagnostic test.”

In addition, the study notes that these numbers contradict previous findings in which over 70% of physicians reported using spirometry for establishing a COPD diagnosis. Given the contrast, Dr. Han suggests a possible difference between what physicians say and what they actually do. Also of particular concern was that, according to this study, spirometry testing in those patients who were 75 years and older was performed less frequently, with only 28% of patients in this population receiving spirometry. Researchers point to the issue of ageism and question whether or not a patient’s age influences a physician’s decision to order diagnostic testing.

“The bad news is that we have significant room for improvement. The good news is that we have to know a problem exists before we can fix it, and now we know,” said Dr. Han. Other good news is that women and men fared virtually the same when it came to spirometry testing, despite previous reports suggesting women were tested less often.

“COPD is currently the fourth leading cause of death in the United States, and the economic burden of this disease is measured in the billions of dollars but, despite this, it is so often underdiagnosed or misclassified,” said Dr. Han. “Prior to this study, I did not truly appreciate the magnitude of spirometry underutilization, but my hope is that this study will lead to more correct diagnoses and better care of patients.”

“Spirometry testing is an inexpensive, quick, and painless procedure, which is necessary to confirm a COPD diagnosis,” said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. “In order to make a shift in the underutilization of spirometry, physicians need to use all of the resources available to them, and patients need to actively inquire about their care.”

The National Lung Health Education Program suggests that current and former smokers aged 45 years and older, as well as any patient who experiences cough, shortness of breath with exertion, or wheezing, ask their doctor about having a spirometry test performed.

CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at chestjournal. The journal’s Web site also provides public access to thousands of archived studies, dating back to 1946 — a newly added feature that is free of charge. The ACCP represents 16,600 members who provide clinical respiratory care, sleep medicine, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP’s mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at chestnet/.

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