Patient Adherence An Essential Factor For Successful Tuberculosis Treatment

Nearly 2 million people die from tuberculosis each year, mainly in the poorest countries. The pathogen, Koch's bacillus, can pass easily by aerial infection from one individual to another. The spread of the disease, favoured by the Aids epidemic and the appearance of multi-resistant strains, has led WHO to make tuberculosis control one of the world's main health priorities. The existing treatment, which combines several antibiotics prescribed for a period of 6 to 8 months as against 18 months to 2 years still only a few years ago - has proved efficient in 95 % of cases. However, this efficacy is called into question by the low adherence of patients to treatment, particularly in the most deprived areas, which are often indeed the worst hit by the disease. In spite of the WHO recommendation to administrate the treatment under the direct supervision of health care personnel who play the role of supporter (DOT : Directly observed therapy), more than 10% of patients stop the treatment before the prescribed period. This defaulting, along with irregularity in taking the medicines, creates increased risk of serious relapse, which opens the way to a rise in transmission events and the emergence of bacteria resistant to the prescribed antibiotics.


Starting from the principle that tuberculosis control must involve the identification of the obstacles to full comprehensive access to treatment, IRD researchers and their partners (1) studied, in Senegal, the different geographical, behavioural and socio-cultural factors that enter into the perception of the treatment and adherence to it. In these countries, where over 9000 new cases of tuberculosis are diagnosed every year, access to free treatment is provided by the National Tuberculosis Control Programme through government health districts (2). However, nearly 30 % of patients do not follow this treatment correctly and scarcely 60% of people ill from the disease receiving a prescription manage to be cured. What are the reasons for this? Long distances from the health centres are among the first difficulties encountered. However, insufficient emphasis on listening to patients, counselling and information provision by health district personnel, associated with shortfalls in following up the DOT strategy also combine to discourage patients from taking the treatment right to the end of the prescribed course. In this context, the researchers looked simultaneously into the relations between health-care staff and the tuberculosis patients, the perception of the disease and its treatment in the community in which they live. They thus proposed action consisting of four major strands: training of health-care personnel, aiming to improve communication and support to patients, the decentralization of access to treatment to offer availability at local medical posts by involving health personnel who are attached to these, reinforcement of the DOT strategy by allowing patients to choose their supporter from among the staff or from within their community (imam, family relation, teacher…) and improved coordination of the activity of medical posts from the district centres.


To test the effectiveness of this action, a randomized controlled clinical trial was run between June 2003 and January 2005 on 16 district health centres and 1522 patients, who were separated at random into two groups. The first group was treated according to the action procedure proposed by the researchers, the second according to the usual strategy of the National Tuberculosis Control Programme (control group). After one year, a distinct improvement in adherence to treatment was observed in the first case: the rate of cure from tuberculosis rose by 20% and the proportion of patients defaulting fell by two-thirds (from 16.8 to 5.5 %).


The training of health-care personnel, communication to inform patients and make them aware of their responsibilities, just as the taking into account of the local, social and cultural context of communities, clearly appear to be essential factors for the sound running of the therapy and the long-term efficacy of actions geared to tuberculosis control. This action strategy, by improving adherence to treatment and the rate of successful patient outcomes, should thus help restrict the spread of the disease and prevent the arrival on the scene of new resistant strains of bacteria. Research work is continuing, in the form of a trial conducted by the IRD in conjunction with WHO, aiming to make available a shorter, 4-month treatment which could lead to still a further improvement of adherence and outcome results.


References


(1)This research involved IRD research unit UR 145 (Programme Tuberculose), the London School of Hygiene and Tropical Medicine, the Programme National de Lutte anti-tuberculeuse of Senegal, and the International Union against Tuberculosis and Lung Diseases, based in Paris.


(2)The standard treatment recommended here lasts 8 months: a 2-month phase to attack the disease by combining rifampicin, isoniazid, pyrazinamid and ethambutol followed by stabilizing phase of 6 months involving combined treatment with isoniazid and ethambutol.


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Privacy Concerns Could Limit Benefits From Real-Time Data Analysis

Society will be unable to take full advantage of real-time data analysis technologies that might improve health, reduce traffic congestion and give scientists new insights into human behavior until it resolves questions about how much of a person's life can be observed and by whom, a Carnegie Mellon University computer scientist contends in a commentary published in the journal Science.



In a "Perspectives" column, Tom M. Mitchell, head of the Machine Learning Department in Carnegie Mellon's School of Computer Science, notes that data-mining techniques, once used for scientific analysis or for detecting potential credit card fraud, increasingly are being applied to personal activities, conversations and movements, such as information that can be deduced about an individual by monitoring that person's smart phone.



"The potential benefits of mining such data range from reducing traffic congestion and pollution, to limiting the spread of disease, to better using public resources such as parks, buses, and ambulance services," Mitchell wrote. "But risks to privacy from aggregating these data are on a scale that humans have never before faced."



Technical means can help limit threats to privacy and misuse of data, Mitchell said. One approach is to mine data from many different organizations without ever aggregating the data into a central repository. For instance, individual hospitals might analyze their medical records to see which treatments work best for a particular flu strain, then use cryptography to encode the results and protect patient privacy; only then would the findings be combined with those from thousands of other hospitals.



"Perhaps even more important than technical approaches will be a public discussion about how to rewrite the rules of data collection, ownership, and privacy to deal with this sea change in how much of our lives can be observed, and by whom," Mitchell wrote. "Until these issues are resolved, they are likely to be the limiting factor in realizing the potential of these new data to advance our scientific understanding of society and human behavior, and to improve our daily lives."



Mitchell pointed out that the use of real-time data from individuals already has begun. In many cities, anonymous location data from smart phones is being used to provide up-to-the-minute reports of traffic congestion. Researchers have shown that by analyzing health-related Google queries from particular geographic areas, they can estimate the level of flu-like illnesses in regions of the U.S. before government agencies such as the Centers for Disease Control and Prevention can provide estimates. Scientists are beginning to use real-time sensing of routine behavior to study interpersonal interactions as people go about their daily lives.



Combining data sets could open up many new possibilities, as well as new privacy issues, Mitchell said. "For example, if your phone company and local medical center integrated GPS phone data with up-to-the-minute medical records, they could provide a new kind of medical service using phone GPS data to detect that you have recently been near a person who is just now being diagnosed with a contagious disease - then automatically phoning to warn you."



A former president of the Association for the Advancement of Artificial Intelligence (AAAI), Mitchell is a member of an AAAI panel that is exploring the potential societal impacts of advances in artificial intelligence. A pioneer in artificial intelligence and machine learning, Mitchell was named a University Professor, the highest distinction that faculty can achieve at Carnegie Mellon, in May 2009. He has been head of the Machine Learning Department since the first-of-its-kind department was established in 2006. His research focuses on statistical learning algorithms for understanding natural language text and on understanding how the human brain represents information.



Source: Byron Spice


Carnegie Mellon University

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Poor housing reason for high asthma rate in the UK

One in twelve children in Britain is at increased risk of developing asthma and other respiratory diseases because of poor housing, according to a new report by Shelter.


The homelessness charity found that more than one million children in England, Wales and Scotland are living in accommodation that jeopardises their health, because it is damp, cold, dirty or infested. People with asthma are twice as likely to live in damp homes, says the report, 'Toying with their future'. Children living in these conditions are also more at risk of developing TB and bronchitis.


'My 10-year-old's asthma is getting worse because of the damp,' one mother in Flintshire was quoted as saying. 'Mould is growing on the carpets and I have to spend loads on heating instead of proper food for my kids.'


'The kids have got used to it because they've grown up here,' said another. 'But if they go to somebody else's house they come back and say why is our flat all black down the walls and theirs' isn't?'


The number of homeless families has increased by 17% since 1997, said Shelter; over a million houses are not fit to live in and more than half a million families live in housing that is officially overcrowded.



The charity said that the rise in house prices and the depletion of affordable social housing means that the number of people living in emergency accommodation has reached record levels.



The UK has the highest rates of childhood asthma in the world, with one in eight children currently being treated for the condition. Research has shown a clear association between poverty and asthma.



'We know that asthma is affected by factors associated with poorer socioeconomic backgrounds and social exclusion, such as damp housing,' said Kate Webb, senior policy and information officer at the National Asthma Campaign.



'Asthma is the most common long term medical condition among children in the UK today,' she added. 'All agencies should be working together to ensure that kids' health does not suffer because of their living environment.



'We shouldn't just be thinking about the asthma symptoms that children are experiencing today, but also about the long-term lung damage that this may be causing.'



asthma/news/news132.php

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Presumptive Republican Presidential Nominee McCain Promotes Health Care Proposal At Miami Children's Hospital

Presumptive Republican presidential nominee Sen. John McCain (Ariz.) on Monday at the Miami Children's Hospital promoted his health care proposal, which he said would "put families in charge," USA Today reports (Jackson, USA Today, 4/29). McCain has proposed to replace a tax break for employees who receive health insurance from employers with a refundable tax credit for the purchase of private coverage and to allow the purchase of health insurance across state lines -- both of which he maintains would promote competition among health insurers, reduce costs and improve quality.

According to McCain, the proposal is "responsive to the needs of American families -- not the government, not the insurance companies, not the tort lawyers, not even the doctors and hospitals" (CNN, 4/28). He added, "I've made it very clear that what I want is for families to make decisions about their health care, not government," which he cited as the major difference between his proposal and the plans announced by Democratic presidential candidates Sens. Hillary Rodham Clinton (N.Y.) and Barack Obama (Ill.) (Reinhard, Miami Herald, 4/29).

Health care is "too expensive," McCain said, adding, "These costs are a threat to the ability of Americans to have health insurance, the gateway to better health care" (CNN, 4/28). In addition, he said, "We must move away from a system that is fragmented and pays for expensive procedures, toward one where a family has a medical home, providers coordinate their efforts and take advantage of technology to do so cheaply, and where the focus is on affordable quality outcomes." McCain added, "America can have a health care system that is characterized by better prevention, coordinated care, electronic health records, cutting edge treatments -- and lower costs" (Reuters, 4/29).

Criticism
In response to the comments from McCain, the Democratic National Committee said that he is "promising four more years of the Bush health care agenda" (CNN, 4/28). Critics argue that the McCain proposal would limit access to health insurance for low-income residents and those with pre-existing medical conditions. In addition, they maintain that his proposal would prompt health insurers to relocate to states with fewer coverage requirements.

On Tuesday, McCain will deliver a policy speech at the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla., that will focus on health care. According to an advance copy of the speech obtained by the Associated Press, McCain will argue that his proposal "would help change the whole dynamic of the current system, putting individuals and families back in charge, and forcing companies to respond with better services at lower costs" (Quaid, AP/Houston Chronicle, 4/29).

Clinton Opinion Piece
Medicare represents a "sacred promise to our seniors and to future generations of American workers," but "the biggest threat" to the program is "skyrocketing health costs," Clinton writes in a Charlotte Observer opinion piece. She writes, "Protecting and strengthening" Medicare "will be a top priority of my administration." According to Clinton, "I will allow imports of certain drugs, remove barriers to generic competition and work to close the 'doughnut hole' in the Medicare prescription drug program," as well as "crack down on overpayments to HMOs in Medicare, which will save more than $10 billion a year."

She adds, "My health plan includes the most aggressive cost-cutting measures of all the candidates," with a focus on "prevention, electronic medical records and chronic care management." In addition, "I have the only plan that will cover every single American," Clinton writes, adding, "Universal health care is essential for lowering health care costs" because when "the uninsured get sick and go to the emergency room for care, we all end up paying in health premiums" (Clinton, Charlotte Observer, 4/28).


Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Poorer Women More Likely To Get Reduced Chemotherapy Dose

Breast cancer patients who have a lower household income and less education may be more likely to receive reduced doses of chemotherapy, according to a new study from a University of Michigan Comprehensive Cancer Center researcher.


In addition, severely obese women were four times as likely as lean women to receive less chemotherapy. Doctors calculate chemotherapy doses for each patient based on her height and weight.


The study looked at 764 women enrolled in the Awareness of Neutropenia in Cancer Study Group Registry, a prospective, multicenter study of cancer patients starting chemotherapy. The researchers looked at women with early breast cancer who were beginning chemotherapy. Study participants enrolled at 115 hospitals and doctors' offices across the country.


Results of the study appear in the Jan. 20 issue of the Journal of Clinical Oncology.


The study authors used U.S. Census Bureau statistics and the women's zip codes to assign each woman a median household income, poverty status and level of education. Information about individual women's actual educational attainment was also collected as part of the study. The researchers then calculated the standard chemotherapy dose, based on each woman's height and weight, and compared that to the initial dose each woman received. A reduced dose was noted for those who received 85 percent or less of the expected standard dose, based on their height and weight.


Researchers found that doctors were more likely to reduce the chemotherapy dose for heavier patients and those who were less educated, and lived in zip codes with lower median household income and higher levels of poverty. Severely obese patients were four times more likely to receive a reduced dose, and women with less than a high school education were three times as likely to have a dose reduction.


When it comes to obese patients, the researchers suggest that doctors reduce the chemotherapy dose because they do not want to give those patients the large dose that their weight would indicate. The motivation is to avoid potential severe and harmful side effects in their patients. For those patients of lower socioeconomic status, doctors may be anticipating the patient's attitude toward treatment, the researchers suspect.


"We speculate that physicians have concerns about a patient's ability to tolerate the side effects of chemotherapy and that the physician's uncertainty about a patient's tolerance increases with increasing social distance. One might just as well ask why we are willing to give full doses to someone with more education. It may be that negotiating side effects and continued doses of treatment is easier when there is more shared culture," says lead study author Jennifer Griggs, M.D., MPH, associate professor of internal medicine at the U-M Medical School. Griggs was at the University of Rochester in Rochester, N.Y., when she completed this research.


Previous studies have shown a connection between obesity and reduced chemotherapy doses. Griggs' work is the first to look at socioeconomic status.


Reduced doses of chemotherapy may reduce its effectiveness in preventing breast cancer from returning. Women seeking treatment for breast cancer can advocate for full doses by indicating their commitment to treatment, Griggs suggests.


"A patient might say to her physician that she is fully committed to her treatment, and in particular, to full doses of chemotherapy. I do not think it is the responsibility of the patient to ensure that she receives full weight-based doses, but physicians may be more comfortable dosing a patient fully when they are assured the patient is committed to her treatment," says Griggs, a member of the U-M Comprehensive Cancer Center.


An estimated 214,640 women will be diagnosed with breast cancer this year.


In addition to Griggs, study authors were Eva Culakova, Ph.D., University of Rochester; Melony E.S. Sorbero, Ph.D., MPH, RAND Corporation; Michelle van Ryn, Ph.D., MPH, University of Minnesota; Marek S. Poniewierski, M.D., University of Rochester; Debra A. Wolff, University of Rochester; Jeffrey Crawford, M.D., Duke University Medical Center; David C. Dale, M.D., University of Washington; and Gary H. Lyman, M.D., MPH, University of Rochester.


The study was not funded, but Amgen Inc. funded the data collection for the ANC Study Group.


Reference: Journal of Clinical Oncology, Vol. 25, No. 3.


University of Michigan Health System

2901 Hubbard St., Ste. 2400

Ann Arbor, MI 48109-2435

United States

med.umich.edu/

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NeurogesX' NGX 4010 MAA Filed And Accepted For Review By EMEA For Treatment Of Peripheral Neuropathic Pain

NeurogesX, Inc.
(Nasdaq: NGSX), a biopharmaceutical company focused on developing novel
pain management therapies, announced that the Marketing Authorization
Application (MAA) submitted by NeurogesX for NGX-4010, the Company's lead
product candidate for peripheral neuropathic pain, has been accepted for
review by the European Medicines Agency (EMEA).


NGX-4010 is a dermal patch that has been studied successfully in three
Phase 3 clinical trials in patients suffering from peripheral neuropathic
pain conditions. Two Phase 3 clinical trials for the treatment of pain
associated with postherpetic neuralgia (PHN) and one for the treatment of
pain associated with painful HIV distal sensory polyneuropathy (HIV DSP)
demonstrated that a single 30 or 60 minute treatment with NGX 4010 applied
directly to the site of pain may provide pain relief for up to 12 weeks.



Completion of the acceptance period (or validation) signifies that the
EMEA will now begin review of NeurogesX' MAA. The review process is being
coordinated by the EMEA under the centralized procedure, which, if
resulting in approval, provides one marketing authorization for all
European Union (EU) Member States, as well as Iceland, Liechtenstein and
Norway.



Dr. Jeffrey Tobias, Chief Medical Officer, commented, "We believe that
the data included in our MAA filing, which includes data from more than
1,400 patients studied in our clinical trials, demonstrates the benefit of
NGX-4010 in treating patients suffering from peripheral neuropathic pain."



Anthony DiTonno, Chief Executive Officer, said, "Validation of our MAA
signifies a critical step in our worldwide NGX-4010 development strategy
and we look forward to productive interactions with the EMEA in order to
potentially gain marketing approval for this novel therapy. We also remain
focused on securing a partnering relationship in Europe prior to market
approval and are currently in active discussions with potential partners
for the commercialization of NGX-4010 in Europe. In addition to our
European filing, we anticipate filing a new drug application or (NDA) for
marketing approval in the United States in 2008."



NeurogesX recently announced that its second Phase 3 trial of NGX-4010
in postherpetic neuralgia (PHN) met its primary and all of its secondary
endpoints. In addition to the Company's PHN studies, NeurogesX has also
conducted a successful Phase 3 clinical trial of NGX-4010 in painful
HIV-DSP. As recently announced, the Company's second, ongoing confirmatory
Phase 3 trial for this indication has reached full enrollment and top-line
results are expected near the end of the first quarter of 2008. NGX-4010
has been granted orphan status and has received fast track designation from
the U.S. Food and Drug Administration (FDA) for HIV-DSP.
















About NGX-4010



NGX-4010 is a non-narcotic, locally-acting analgesic formulated in a
dermal patch containing capsaicin, a highly selective TRPV1 agonist.
Capsaicin is released from the patch and absorbed into the skin without
significant absorption into the bloodstream. Accordingly, users of NGX-4010
may be able to avoid the systemic side effects of anti-convulsants,
anti-depressants and opioids, including sedation and the potential for
abuse and addiction associated with some of these drugs. NGX-4010 is
administered in a physician's office in a non-invasive process. In three
Phase 3 clinical trials, NGX-4010 has been shown to reduce peripheral
neuropathic pain for up to 12 weeks.



About PHN and HIV-DSP



PHN is a painful condition affecting sensory nerve fibers. It is a
complication of shingles, a second outbreak of the varicella-zoster virus,
which initially causes chickenpox. Following an initial infection, some of
the virus can remain dormant in nerve cells. Years later, age, illness,
stress, medications or other factors that are not well understood can lead
to reactivation of the virus. The rash and blisters associated with
shingles usually heal within six weeks, but some people continue to
experience pain for years thereafter. This pain is known as postherpetic
neuralgia. PHN may occur in almost any area, but is especially common on
the torso.



HIV-DSP is caused primarily by three factors: direct activation of
cells known as sensory neurons by the HIV virus, the immune system's fight
against the infection, and the drugs administered to treat HIV. Painful
HIV-DSP is characterized by significant pain in the feet and hands.



About NeurogesX, Inc.



NeurogesX (Nasdaq: NGSX) is a biopharmaceutical company focused on
developing novel pain management therapies. Its initial focus is on chronic
peripheral neuropathic pain, including PHN, painful HIV-DSP and painful
diabetic neuropathy (PDN). NeurogesX's late stage product portfolio is led
by product candidate NGX-4010, a dermal patch designed to manage pain
associated with peripheral neuropathic pain conditions, that the Company
believes offers significant advantages over other pain therapies. Three
Phase 3 clinical trials with NGX-4010 have been completed and have met
their primary endpoints, two in PHN and one in HIV-DSP.



Safe Harbor Statement



This press release contains forward-looking statements for purposes of
the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX
disclaims any intent or obligation to update these forward-looking
statements, and claims the protection of the Safe Harbor contained in the
Act for forward- looking statements. Examples of such statements include,
but are not limited to, statements regarding NGX-4010 clinical trials,
including the timing of completion of such trials; filings for regulatory
approval in the United States and the timing of such filings as well as the
scope of the indications that the Company is seeking approval for with
respect to its filing with the EMEA; the potential markets for NGX-4010;
the potential efficacy and benefits of NGX-4010; and NeurogesX' plans to
enter into commercial partnerships. Such statements are based on
management's current expectations, but actual results may differ materially
due to various risks and uncertainties, including, but not limited to,
subsequent analysis of data from NeurogesX' C117 trial may cause the
results to be viewed less favorably as compared to NeurogesX' initial
analysis of such trial's results; past results of clinical trials may not
be indicative of future clinical trials results; NGX-4010 may have
unexpected adverse side effects or inadequate therapeutic efficacy;
positive results in clinical trials may not be sufficient to obtain FDA or
European regulatory approval; physician or patient reluctance to use
NGX-4010, if approved, or the inability of physicians to obtain sufficient
reimbursement for such procedures; potential alternative therapies and
changing standards of care; maintaining adequate patent or trade secret
protection without violating the intellectual property rights of others;
NeurogesX' ability to obtain additional financing; NeurogesX' ability to
obtain and maintain future commercial partnerships; and other difficulties
or delays in clinical development, obtaining regulatory approval, market
acceptance and commercialization of NGX-4010. For further information
regarding these and other risks related to NeurogesX' business, investors
should consult NeurogesX' filings with the Securities and Exchange
Commission.


NeurogesX, Inc.

neurogesx

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Pharmacopeia's First-in-Class Investigational Therapy PS433540 Achieves Statistically Significant Reductions In Blood Pressure In Hypertensive Patient

Pharmacopeia (Nasdaq:
PCOP), an innovator in the discovery and development of novel small
molecule therapeutics, announced that PS433540, its first-in-class
Dual Acting Receptor Antagonist (DARA), showed statistically significant
blood pressure reductions in a Phase 2a study in patients with mild to
moderate hypertension. PS433540 is being developed as a potential treatment
for both hypertension and diabetic nephropathy and is a novel blood
pressure product candidate that possesses two validated mechanisms of
action in a single molecule. The data will be presented today at the Recent
and Late Breaking Clinical Trials Session at the American Society of
Hypertension (ASH) Twenty-Third Annual Scientific Meeting and Exposition in
New Orleans.


The Phase 2a study met its primary endpoint by showing a statistically
significant reduction in mean 24-hour systolic ambulatory blood pressure
over placebo. The study also showed statistically significant improvements
over placebo in mean 24-hour diastolic ambulatory blood pressure as well as
seated blood pressure. In this double-blind, placebo-controlled study,
patients treated with 200 mg of PS433540 once daily experienced a 12/9mmHg
drop in mean 24-hour systolic and diastolic blood pressure and those
treated with 500 mg experienced a 15/10mmHg drop in mean 24-hour systolic
and diastolic blood pressure. These reductions were highly statistically
significant vs. placebo (P








"These positive results indicate that PS433540 may be a unique new
treatment option for physicians and patients," said Joel Neutel, M.D.,
Associate Professor of Medicine in the Department of Medicine at the
University of California in Irvine, and Medical Director of Clinical
Pharmacology at the Orange County Research Center in Tustin, CA, who was
the lead investigator of the Phase 2a study. "The magnitude of the blood
pressure reductions we saw in this study were very impressive, and we look
forward to further evaluating the benefits of this novel compound."



An estimated 73 million Americans suffer from high blood pressure, a
major risk factor for cardiovascular events and heart disease.(3) More than
half of people diagnosed and treated with high blood pressure never reach
suggested treatment goals and those who do often require two or more
medications.(4) PS433540 is the first and only compound specifically
designed to incorporate two proven mechanisms -- endothelin (ETA) and
angiotensin (AT1) receptor blockade -- in one molecule to treat high blood
pressure.



"We are very pleased with the results of this important Phase 2a trial
and look forward to future studies which will further assess the potential
of PS433540, perhaps even beyond blood pressure lowering," said Joseph A.
Mollica, Ph.D., Chairman of the Board and Interim President and Chief
Executive Officer of Pharmacopeia. "We believe PS433540's dual mechanism of
action may have a positive effect on diabetic kidney disease."



Patients with diabetes are at an increased risk for many complications,
including high blood pressure and diabetic kidney disease. Up to 73 percent
of patients with diabetes have been or are being treated for high blood
pressure,(5) and an estimated 20-30 percent of diabetic patients will
progress to diabetic kidney disease,(6) a devastating disease that may
require patients to undergo dialysis or a kidney transplant.(7)



Pharmacopeia recently initiated a 12-week, Phase 2b clinical trial with
PS433540 to evaluate the compound's safety and efficacy at three different
doses versus placebo in 375 subjects with Stage I and Stage II
hypertension. The study will also compare blood pressure reductions for
each dose with irbesartan. Pharmacopeia anticipates completion of the Phase
2b trial at the end of 2008.



About the Phase 2a study



In this prospective study, 234 men and women with Stage I and Stage II
hypertension entered into a single blind placebo run-in period for 3-4
weeks, after which 114 were randomized to receive double blind study
medication for four weeks. At the time of the database lock, 108 subjects
were available for evaluation, 93 of whom had both baseline and follow-up
ambulatory blood pressure measurements (placebo: 25; PS433540 200mg: 35;
PS433540 500mg: 33). The primary endpoint was the subjects' change from
baseline in mean 24-hour systolic ambulatory blood pressure after 4 weeks
of treatment. Additionally, investigators evaluated 24-hour diastolic
ambulatory blood pressure and mean seated office systolic and diastolic
blood pressure as well as a number of other endpoints.



About PS433540



PS433540 is the first and only blood pressure product candidate in a
new class of antihypertensives known as Dual Acting Receptor Antagonists
(DARAs). PS433540 is being developed as a potential treatment for
hypertension and diabetic nephropathy. PS433540 possesses two clinically
validated mechanisms of action in a single molecule. There is preclinical
and initial clinical data suggesting that compared to either mechanism
alone, simultaneously blocking angiotensin II and endothelin 1 at their
respective receptors, AT1 and ETA, may provide an improved treatment option
for several cardiovascular diseases. Because PS433540 is highly selective
for the AT1 and ETA receptors it is able to block the blood
pressure-raising actions of angiotensin and endothelin when they bind to
these receptors.



About Pharmacopeia



Pharmacopeia is a clinical development stage biopharmaceutical company
dedicated to discovering and developing novel small molecule therapeutics
to address significant medical needs. The company has a broad portfolio of
clinical and preclinical candidates under development internally or by
partners including eight clinical compounds in Phase 2 or Phase 1
development addressing multiple indications including hypertension,
diabetic nephropathy, muscle wasting, inflammation and respiratory disease.
The company is leveraging its fully integrated drug discovery platform to
sustain the growth of its development pipeline. Pharmacopeia has
established strategic alliances with major pharmaceutical and biotechnology
companies, including Bristol-Myers Squibb, Celgene, Cephalon,
GlaxoSmithKline, Schering-Plough, and Wyeth Pharmaceuticals. For more
information please visit the company's website at
pharmacopeia.


This press release, and oral statements made with respect to
information contained in this press release, constitute forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements include those which express
plan, anticipation, intent, goal, contingency or future development and/or
otherwise are not statements of historical fact. These statements are based
upon management's current expectations and are subject to risks and
uncertainties, known and unknown, which could cause actual results and
developments to differ materially from those expressed or implied in such
statements. These forward- looking statements include, but are not limited
to, statements about the results of Pharmacopeia's Phase 2a clinical study
of PS433540, a product candidate from its DARA program, Pharmacopeia's
plans to develop PS433540, Pharmacopeia's other Phase 2 and Phase 1
clinical studies with respect to PS433540, including timing and expected
outcomes of such studies, Pharmacopeia's estimates of the market
opportunities for PS433540, the implementation of Pharmacopeia's strategic
plans, Pharmacopeia's plans to develop PS178990, a product candidate from
its SARM program, Pharmacopeia's Phase 1 clinical studies with respect to
PS178990, including timing and expected outcomes of such studies,
Pharmacopeia's plans to develop PS031291, a product candidate from its
chemokine receptor CCR1 program, Pharmacopeia's estimates of the market
opportunities for its other product candidates, including PS178990 and
PS031291, Pharmacopeia's ability to raise additional capital,
Pharmacopeia's anticipated operating results, financial condition,
liquidity and capital resources, Pharmacopeia's ability to successfully
perform under its collaborations with Bristol-Myers Squibb, Cephalon,
GlaxoSmithKline, Schering-Plough and Wyeth, Pharmacopeia's ability to build
its pipeline of novel drug candidates through its own internally-funded
drug discovery programs, third party collaborations and in-licensing,
Pharmacopeia's expectations concerning the development priorities of its
collaborators, their ability to successfully develop compounds and its
receipt of milestones and royalties from the collaborations, Pharmacopeia's
expectations concerning the legal protections afforded by U.S. and
international patent law, Pharmacopeia's ability to pursue the development
of new compounds and other business matters without infringing the patent
rights of others, additional competition, and changes in economic
conditions.



Further information about these and other relevant risks and
uncertainties may be found in Pharmacopeia's Reports on Form 8-K, 10-Q and
10-K filed with the U.S. Securities and Exchange Commission. Pharmacopeia
urges you to carefully review and consider the disclosures found in its
filings which are available in the SEC EDGAR database at sec
and from Pharmacopeia at pharmacopeia. All forward-looking
statements in this press release and oral statements made with respect to
information contained in this press release are qualified entirely by the
cautionary statements included in this press release and such filings.
These risks and uncertainties could cause actual results to differ
materially from results expressed or implied by such forward-looking
statements. These forward-looking statements speak only as of the date of
this press release. Pharmacopeia undertakes no obligation to (and expressly
disclaims any such obligation to) publicly update or revise the statements
made herein or the risk factors that may relate thereto whether as a result
of new information, future events, or otherwise.


References


(1) Prescribing Information for Coreg CR(R), Lotensin(R), Avapro(R),
Benicar(R) and Norvasc(R)


(2) American Heart Association news release.
americanheart.mediaroom/index.php?s=43&item=59. Accessed
April 7, 2008.


(3) AHA 2007 Heart Disease and Stroke Statistics, p. 3.


(4) Chobanian AV, Bakris GL, Black HR, et al. The Seventh Report of the
Joint National Committee on Prevention, Detection, valuation, and
Treatment of High Blood Pressure. Journal of the American Medical
Association. 2003;289:p.2560-2572.


(5) American Diabetes Association:
diabetes/utils/printthispage.jsp?PageID=STATISTICS_233192.
Accessed April 4, 2008.



(6) Diabetes Care, Volume 27, Supplement 1, January 2004.



(7) National Institute of Diabetes and Digestive and Kidney Diseases.



Pharmacopeia

pharmacopeia

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Phase I Radiation Oncology Clinical Trials Are More Toxic Than Suspected

Risks to patients enrolled in Phase I radiation oncology clinical trials are higher than previously appreciated, according to a study conducted by researchers from the Kimmel Cancer Center at Jefferson. The findings will be presented at the American Society of Radiation Oncology (ASTRO) annual meeting in San Diego.


The researchers, who reviewed 102 radiation oncology phase I clinical trials conducted around the world, found the risk of major toxicity was significant there were four major toxic events for every 10 patients treated. The risk of death, however, was low at less than one percent.


"We had anticipated risk of serious toxicity to be around 10 percent, so we were surprised, and concerned, to find the actual risk is significantly higher," says the study's senior investigator, radiation oncologist Yaacov Richard Lawrence, M.R.C.P., assistant professor at Thomas Jefferson University. "Although high, the risk is very similar to that patients encounter when they enter phase I trials that do not involve radiation."


The findings are important because they can be used to provide a truer sense of risk to patients who enroll in these clinical trials, he says. "Before entering a trial patients sign an informed consent that explains benefits and risks, so it is important for us and for our patients to have a truer picture of these risks."


They also suggest that designs and reporting of phase I radiation oncology clinical trials should be more consistent, says Dr. Lawrence. "The nature of these trials is that it is much easier to quantify risk than potential benefits."


The findings are being presented at ASTRO by co-author Robert Den, M.D., a resident within the radiation oncology department. Much of the work was performed by Charles Glass, a fourth year medical student.


The research team examined phase I and phase I/II clinical trials published between 2001 and 2009 that included radiation therapy. Many of these trials involved combining radiation with cytotoxic agents (such as chemotherapy) or with biologic drugs. Most of the trials (59 percent) were performed in the U.S., 66 percent were multinational, 17 percent were conducted by a cooperative research group, 68 percent were phase I and 32 percent were phase I/II. The majority of the trials (71) involved dose escalating the chemotherapeutic or biologic agent delivered with radiotherapy; 21 trials tested dose escalation of radiotherapy alone, two trials escalated both radiotherapy and/or a chemotherapeutic agent, and eight trials involved radiotherapy that was not dose escalated.


The trials involved lung (22 percent), brain (12 percent), rectum (11 percent), and head and neck (11 percent) cancers.


In all, 4,553 patients were enrolled in these studies. After a median follow-up of more than two years, there were a total of 39 treatment-related deaths, and 1,881 major acute toxicities (defined as grade 3 or worse).


Still, it is important to remember that "patients enter phase I trials because they are facing a serious problem and hence need to balance the perceived risks with the potential benefits," says Adam Dicker, MD, PhD, Professor and Chairman of the Department of Radiation Oncology at Jefferson.


The majority of side effects were seen in studies that tested use of a combination of chemotherapy and radiation at the same time, Dr. Lawrence says. "We may not see as much toxicity from this point on, because most clinical trials today are looking at newer less toxic medicines," he says.


There was no external funding for this study.


Source: Thomas Jefferson University

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Number Of Retail Clinics Continues To Increase, Analysts Say

The Philadelphia Inquirer on Monday examined how retail medical clinics "are springing up in drug, grocery and big-box stores around the country" as "a growing number of entrepreneurs see them as a way to make money while making the simplest medical care ... cheaper and more convenient." According to Mary Kate Scott -- a Los Angeles health care consultant who wrote a recent report on the trend for the California HealthCare Foundation -- the number of retail medical clinics in the U.S. has increased from 60 in January 2006 to 300 today. Scott said she expects the number of clinics to double by the end of 2007 and to reach 2,500 to 3,000 within five years. She called the clinics a "true innovation in health care delivery," adding, "What I think is really important ... is that they are making everyone in the health care system say: 'Hang on. Is there a new and better way to do it?'" Hal Rosenbluth, cofounder of Take Care Health Systems -- a clinic company based in Pennsylvania -- said, "We built a model for immediate gratification, which is what somebody wants when they're ill, or their child is ill." The Inquirer notes that some physicians' groups are critical of retail clinics, saying that they should have strict limits and physician oversight (Burling, Philadelphia Inquirer, 3/12).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Most People Support Comprehensive Sex Education, Opinion Piece Says

Although many people believe there is a "deep schism" between Americans who support abstinence-only sex education and those who support comprehensive sex education, this notion is "utterly false," columnist Anna Quindlen writes in a Newsweek opinion piece that will appear in the March 16 issue. According to Quindlen, although Americans disagree about "whether more emphasis should be on contraception or on abstinence," nearly 90% of respondents to recent polls report supporting sex education in schools. She continues, "I'm not sure that many people would agree about teaching long division." However, despite these "astonishing" poll results, "none of this is what you would hear if you put your ear to the ground in Washington, D.C.," Quindlen writes.

According to Quindlen, "In yet another example of how things can go horribly awry within that zone of magical thinking, Congress has poured $1.5 billion into what is essentially anti-sex ed, abstinence-only programs" despite three facts. First, abstinence-only programs "don't work," Quindlen writes, citing an HHS study conducted during former President George W. Bush's administration that found that young people who took abstinence-only classes were just as likely to have sex as those who did not take the classes. In addition, Quindlen writes that abstinence-only programs are "actually counterproductive" because studies indicate that students in these programs are less likely to use contraception when they become sexually active. Finally, Quindlen writes that "everyone understands" the shortcomings of abstinence-only programs, which is why a "growing number of states are turning down federal funds for abstinence-only education."

Quindlen writes that President Obama's budget "seems to reflect the sentiment of most Americans, promising to 'stress the importance of abstinence while providing medically accurate and age-appropriate information to youth who have already become sexually active.'" She continues, "In our current straitened economic atmosphere, there must be no more of what our grandmothers called 'throwing good money after bad' for junk virginity pedagogy that emphasizes the eww factor with photographs of lesions."

Quindlen writes that because Americans have "become accustomed to thinking there are two sides" to every issue, they believe that there are two equal sides, "especially the ones on which people scream the loudest." She continues, "Perhaps this issue offers an opportunity for elected-official ed too," noting that it is "worth looking past the dueling paid faces to actual public opinion about what appear to be contentious issus -- but sometimes aren't." Quindlen writes that "[c]ommon sense dictates that schools should offer a comprehensive view of sexual behavior, including a guide to those measures that can help sexually active students avoid visiting an abortion clinic or experiencing burning during urination." Quindlen concludes that "elected officials might try a comprehensive view, too, before they use scarce resources on programs they've embraced mainly because they do not offer the inconvenience of complexity" (Quindlen, Newsweek, 3/16).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


© 2009 The Advisory Board Company. All rights reserved.

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Psychiatry Symposium To Address Collaborations In Mood Disorder Research, Treatments

The Johns Hopkins University School of Medicine will hold its 24th Annual Mood Disorders Research and Education Symposium on April 20, focusing on joint efforts between researchers and clinicians to study and treat depression and bipolar disease.


Speakers on these topics from Hopkins and elsewhere will give talks from 12:45 p.m. to 6 p.m. in Turner Auditorium on Johns Hopkins Medicine's East Baltimore campus.


Among the presenters:


- Col. Elspeth Cameron Ritchie, M.D., adult and forensic psychiatrist and medical director of the Army Medical Department's Office of Strategic Communications. An internationally recognized expert, she brings a public health approach to the management of disaster- and combat-related mental health issues. She will address the challenges of recognizing and treating mood disorders and posttraumatic stress disorder in the military communit


- Kay Redfield Jamison, Ph.D., professor of psychiatry and behavioral sciences, co-director of the Johns Hopkins Mood Disorders Center, and an internationally recognized author. She will offer a historical perspective on mood disorders focusing on the biography of 19th century poet Nathaniel Hawthorne.


- James Potash, M.D., M.P.H., associate professor of psychiatry at the Johns Hopkins University School of Medicine, will describe current collaborative efforts to understand the underlying causes of mood disorders through genetic research. His recent research includes the identification of a novel genetic component in major depression, found by analyzing data from three major genetic studies of mood disorders.



Other speakers include Karen Swartz, M.D., director of the Mood Disorders Clinical Programs at the Johns Hopkins University School of Medicine; John Greden, M.D., former chair of psychiatry at the University of Michigan, founder of the Michigan Depression Center, and founding chair of the National Network of Depression Centers; Frank DeGruy, M.D., M.S.F.M., professor and chair of the Department of Family Medicine and director of primary care outreach and research at the University of Colorado Denver School of Medicine; and David A. Axelson, M.D., associate professor of psychiatry at the University of Pittsburgh School of Medicine and director of the Child and Adolescent Bipolar Services Program at the Western Psychiatric Institute and Clinic.


Mood disorders are among the most common illnesses in the world. An estimated 20 percent of adults suffer from depression or bipolar disorder.


Intended for psychiatrists, social workers, psychologists and counselors, the symposium is also open to patients, family members and anyone who has an interest in learning more about bipolar disorders and recurrent depression.


The symposium is presented by the Johns Hopkins Department of Psychiatry and Behavioral Sciences, the Johns Hopkins Mood Disorders Center and the Institute for Johns Hopkins Nursing.

Source
Johns Hopkins Medicine

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Olanzapine Long-Acting Injection (LAI) Efficacy And Safety Data Presented At American Psychiatric Association Annual Meeting

Eli Lilly and Company presented data on the short- and long-term efficacy and safety of olanzapine long-acting injection (LAI) in the treatment of adults with schizophrenia or schizoaffective disorder. Olanzapine LAI is an investigational formulation that combines the atypical antipsychotic Zyprexa(R) (olanzapine) with pamoic acid, allowing for the sustained delivery of olanzapine for up to four weeks.


Results from a 190-week interim analysis of a six-year, ongoing, open-label study (HGKB), showed that adults with schizophrenia or schizoaffective disorder treated with olanzapine LAI had a discontinuation rate of 46.3 percent. The most common reason for discontinuation was the patient's decision (23.4 percent) followed by adverse events (6.7 percent). Safety findings were consistent with those observed with oral olanzapine, with the exception of injection-related events, including post-injection delirium/sedation syndrome (PDSS), which is characterized by sedation- and/or delirium-related symptoms following injection.


"Discontinuation of medication plays a major role in schizophrenia relapse," said Holland Detke, Ph.D., clinical research scientist at Lilly. "Four out of five patients who stop taking their medications after a first episode of schizophrenia will have a relapse. The more relapses a patient has, the more difficult it becomes for them to recover from each successive relapse."(1)


Also presented were eight-month interim results from a two-year, ongoing, open label study (HGLQ) that showed patients with schizophrenia could be switched to olanzapine LAI from a previous antipsychotic, either using a direct switch or while tapering their previous antipsychotic medication. No significant difference was found in overall rate of treatment discontinuation or mean change in PANSS score, two standard measures of treatment effectiveness in schizophrenia, among patients who were switched directly to olanzapine LAI and those who were tapered. Additionally, no significant differences were seen in the overall number of treatment-emergent adverse events, changes in laboratory measures or mean weight change.


Regulatory reviews for olanzapine LAI are ongoing in the United States and other countries. Olanzapine LAI is approved in the European Union under the brand name Zypadhera(R) for maintenance treatment of adults with schizophrenia who have been sufficiently stabilized during acute treatment with oral olanzapine.


Additional olanzapine LAI data presented today at the annual meeting of the American Psychiatric Association include: an analysis of the role of oral supplementation in the administration of long-acting antipsychotics; an analysis of PDSS; and a meta-analysis of olanzapine LAI, olanzapine and haloperidol data. Additionally, a cost-effectiveness simulation analysis comparing olanzapine LAI to risperidone LAI, haloperidol LAI and oral olanzapine was presented.















About HGKB


The primary objective of this ongoing open-label study is to examine the long-term safety and tolerability of olanzapine LAI. Current results are from an interim analysis, with maximum treatment duration of 190 weeks. Adult patients with schizophrenia or schizoaffective disorder (N=931) were enrolled following one of three randomized, controlled studies of olanzapine LAI, in which patients had been randomly assigned to oral olanzapine, olanzapine LAI or placebo. During the open-label extension, all patients received flexibly-dosed olanzapine LAI at injection intervals of approximately two to four weeks.


At time of analysis, rate of study discontinuation was 46.3 percent. Discontinuation rate at 18 months was 34.3 percent. The most common reasons for discontinuation were patient's decision (23.4 percent), followed by adverse events (6.7 percent). Adverse events in greater than or equal to five percent of patients were increased weight, insomnia, anxiety, somnolence, headache and inflammation of the nasal passages and upper pharynx (nasopharyngitis).


Safety findings were consistent with those observed with oral olanzapine, with the exception of injection related events, including PDSS. There were 26 occurrences of PDSS. All of these patients recovered within 72 hours. Mean weight change was +1.88 kg, with 32.1 percent of patients experiencing greater than or equal to seven percent weight gain. Percentages of patients who increased from normal to high on fasting glucose, random total cholesterol, or random triglycerides were 5.5 percent, 5.2 percent and 14.3 percent, respectively. Mean Clinical Global Impressions-Severity scores remained stable throughout (2.9 at baseline to 2.8 at endpoint).


About HGLQ


The primary objective of this two-year, ongoing open-label study is to compare the treatment effectiveness of the oral and long-acting formulations of olanzapine in adult outpatients with schizophrenia considered at risk for relapse. The eight-month interim analysis of this study was conducted in order to compare the safety and effectiveness of direct switch versus taper of previous antipsychotic medication when changing to olanzapine LAI. Analyses were based on eight-month data from only those patients treated with olanzapine LAI (N=264). Patients received olanzapine LAI every four weeks with a starting dose of 405 mg and flexible dosing thereafter. Investigators, at their discretion, could either directly switch patients or taper their previous antipsychotic medication during the first two weeks of treatment.


At the time of study entry, patients were either receiving typical antipsychotics (N=63), atypical antipsychotics (N=188) or not receiving any antipsychotics at all (N=34). Of those receiving atypical antipsychotics, 76 were taking oral olanzapine and 16 were on an injectable antipsychotic medication other than olanzapine LAI.
Of 264 total patients, 150 (56.8 percent) were switched directly and the rest were tapered. The two groups did not significantly differ in discontinuation rate (direct: 29.3 percent, taper: 28.9 percent), and there was no significant difference between the groups on PANSS total score mean change at any visit up to eight months (direct: -1.5, taper: -3.4, from a mean baseline of 56.7).


Treatment-emergent adverse events in greater than or equal to five percent of patients were: increased weight (10.2 percent), insomnia (8.3 percent), anxiety (6.8 percent), somnolence (6.8 percent) and increased appetite (5.7 percent). The switch groups did not significantly differ in mean weight change, with an average weight gain of 2.0 kg, nor did they significantly differ in terms of laboratory analytes.


About PDSS


PDSS describes a range of signs and symptoms similar to those observed with oral olanzapine overdose that have been seen in 0.07 percent of olanzapine LAI injections in clinical trials as of February 22, 2009. These signs/symptoms include: sedation (ranging from mild in severity to unconsciousness) and/or delirium (including confusion, disorientation, agitation, anxiety or other cognitive impairment).


Other symptoms can include extrapyramidal symptoms (such as restlessness, muscle stiffness, random movements and tremors), difficulty articulating words (dysarthria), loss of coordination (ataxia), aggression, dizziness, weakness, hypertension and convulsions. As of February 22, 2009, across all clinical trials, PDSS events have been seen in approximately 2 percent of patients, all of whom have recovered. The majority of these patients have chosen to continue treatment with olanzapine LAI. Lilly has proposed a comprehensive plan to the FDA in order to help ensure the appropriate identification and management of PDSS.


About Long-acting Injectable Antipsychotic Medications


The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines state that poor or partial treatment compliance is a major problem in the long-term treatment of schizophrenia.(2)


Long-acting antipsychotic formulations have been associated with improved treatment adherence and reduced treatment failures.(3) By administering long-acting medications, healthcare professionals know when patients have received their medication and can immediately detect non-adherence when a patient fails to return for a scheduled injection.(4) Different from both oral and injected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.(5)


About Schizophrenia


Schizophrenia is a severe and debilitating illness with symptoms such as delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices or visions), disorganized speech and severe disorganized or catatonic behavior. These signs and symptoms are associated with marked social or occupational dysfunction. Features of schizophrenia consist of characteristic signs and symptoms that have been present for a significant portion of time during a one-month period, with some signs of the disorder persisting for at least six months.(6) In addition to these symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.


Safety information for Oral Zyprexa (olanzapine)


Zyprexa is indicated in adults in the United States for the acute- and maintenance treatment of schizophrenia, acute mixed and manic episodes of bipolar I disorder, and maintenance treatment of bipolar disorder.


Zyprexa is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.


In addition, compared to elderly patients with dementia-related psychosis taking a placebo, there was a significantly higher incidence of cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with Zyprexa.


The possibility of a suicide attempt is inherent in schizophrenia and bipolar I disorder. Close supervision of high-risk patient should accompany drug therapy.


As with all antipsychotic medications, a rare and potentially fatal condition known as Neuroleptic Malignant Syndrome (NMS) has been reported with Zyprexa. If signs and symptoms appear, immediate discontinuation is recommended. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.


Hyperglycemia, in some cases associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics, including Zyprexa. While relative risk estimates are inconsistent, the association between atypical antipsychotics and increases in glucose levels appears to fall on a continuum and Zyprexa appears to have a greater association than some other atypical antipsychotics. Physicians should consider the risks and benefits when prescribing Zyprexa to patients with an established diagnosis of diabetes mellitus, or having borderline increased blood glucose level. Patients taking Zyprexa should be monitored regularly for worsening of glucose control. Patients starting treatment with Zyprexa should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, palyphagia and weakness. Patients who develop symptoms of hyperglycemia during treatment should undergo fasting blood glucose testing.


Undesirable alterations in lipids have been observed with Zyprexa use. Clinical monitoring, including baseline and follow-up lipid evaluations in patients using Zyprexa, is advised. Significant, and sometimes very high, elevations in triglyceride levels and modest mean elevations in total cholesterol have been observed with Zyprexa use.


Potential consequences of weight gain should be considered prior to starting Zyprexa. Patients receiving Zyprexa should receive regular monitoring of weight.


As with all antipsychotic treatment, prescribing should be consistent with the need to minimize Tardive Dyskinesia (TD). The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.


Zyprexa may induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia, and in some patients, syncope, especially during the initial dose-titration period. Particular caution should be used in patients with known cardiovascular disease, cerebrovascular diseases, or those predisposed to hypotension.


Other potentially serious adverse events include seizures, elevated prolactin levels, elevated liver enzymes, cognitive and motor impairment, body temperature elevation and trouble swallowing.


The most common treatment-emergent adverse event associated with Zyprexa use in adults in placebo-controlled, short-term schizophrenia and bipolar mania trials was somnolence. Other common events were dizziness, weight gain, personality disorder (COSTART term for nonaggressive objectionable behavior), constipation, akathisia, postural hypotension, dry mouth, asthenia, dyspepsia, increased appetite and tremor.


About Lilly


Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.


This press release contains forward-looking statements about the safety and efficacy of olanzapine long acting injection (LAI) and reflects Lilly's current beliefs. However, as with any investigational pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, regulatory milestones and commercialization. There is no guarantee that olanzapine LAI will be approved for the treatment of schizophrenia or that if approved, it will be commercially successful.


For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.


References



1. "Expert Consensus Guideline Series," J Clin Psychiatry, 1999:60 (suppl11).



2. Falkai P., Wobrock T., Lieberman J., Glenthoj B.,Gattaz W.F., Moller H.J & Wfsbp Task Force On Treatment Guidelines For Schizophrenia. The World Journal of Biological Psychiatry, 2006; 7(1): 5/40



3. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.



4. Kane J.M et al. Guidelines for depot antipsychotic treatment in schizophrenia. European Neuropsychopharmacology, Volume 8, Number 1, 1 February 1998, pp. 55-66(12). p. 58.



5. Maxine X. Patel and Anthony S. David. Why aren't depot antipsychotics prescribed more often and what can be done about it? Advances in Psychiatric Treatment (2005) 11: 203-211.



6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, fourth edition, 2000, pp. 298.


Source: Eli Lilly and Company



View drug information on Zyprexa.

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Palliative Care Improvements Needed As Baby Boomers Age

A baby "boomer-driven movement" could prompt needed improvements in palliative care for U.S. residents and "reclaim death from high-tech machines in intensive care units," according to experts, the Baltimore Sun reports. According to experts, as baby boomers "confront the tough clinical realities of dying through their own parents' experiences, they will insist that the final stage of life becomes as personal and family based as the first," the Sun reports. Marian Grant, coordinator of palliative care at the Johns Hopkins Bayview Medical Center geriatrics department, said, "There are not a whole lot of choices in the hospital at the moment for people who are dying. You have to know enough to be able to say 'I need to see someone about pain management. My mother isn't comfortable and what are you going to do about that?'" Ira Byock, chair of palliative medicine at Dartmouth Medical School, said that improvements in palliative care are needed to prevent a "true public health crisis" as baby boomers age. "Although most people would prefer to die at home, only 20% do," Byock said, adding, "About 60% die in hospitals, about 20% die in nursing homes. ... If we don't make major changes in the way we plan for the last chapter of life, the baby boom generation is going to stress our health systems in ways they have never been challenged before" (Smith, Baltimore Sun, 12/3).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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Psychology Professor Develops New Model For Collaboration Between Clergy And Clinicians

Many of the clergy who lead America's 260,000 religious congregations turn to psychologists who share their religious values when they refer congregants to social workers. However, this approach could impede people from getting the care they need, maintains Dr. Glen Milstein, Professor of Psychology at The City College of New York (CCNY).



For the past decade, Professor Milstein has led a multidisciplinary team of researchers in developing a new model for relationships between clergy and clinicians that is religion inclusive rather than faith based. Known as C.O.P.E. (Clergy Outreach and Professional Engagement), the approach is design to reduce burdens on both professions. It was described in detail earlier this year in the American Psychological Association's journal Professional Psychology: Research and Practice.



The key to the C.O.P.E. model is the recognition that mental illness is a chronic disease with which patients sometimes can function and other times can not, Professor Milstein explains. "Clinicians and clergy perform distinct, complementary functions in treating these syndromes. While clinicians provide professional treatment to relieve individuals of their pain and suffering and move them from dysfunction to their highest level of function, clergy and religious communities provide a sense of context, support and community before, during and after treatment."



The program aims to improve care of individuals by facilitating reciprocal collaboration between clinicians and members of the clergy, regardless of either's religious affiliations. It is based on two principal ideas: The first is that clergy and clinicians can better help a broader array of persons with emotional difficulties and disorders through professional collaboration than they can by working alone, and secondly, that the program's success is predicated on collaboration easing the workload for both groups.



Professor Milstein describes the approach as "religion-inclusive" since it calls upon the therapist to both assess the role of religion in the patient's life and to educate themselves about the patient's religious tradition. Often that education includes contact with the patient's clergy.



Faith-based approaches, which call for the individual to be referred to a clinician from his or her own faith, can restrict care by excluding access to professionals best able to treat the condition, he maintains. Professor Milstein cites a research study comparing the work of religious psychotherapists with the work of nonreligious psychotherapists in treating religious Christians. The study found that nonreligious therapists who provided religiously informed psychotherapy achieved the best clinical outcomes for this group.



Working from the National Institute of Mental Health's four prevention categories, Professor Milstein and his team developed two handouts, one for mental health professionals and the other for clergy. They provide descriptions in a hierarchal format of the four care stages and illustrate when it would be appropriate for clergy to contact clinicians and for clinicians to contact clergy.



The goal of C.O.P.E., Professor Milstein explains, is for clergy and clinicians to provide a continuum of care, whether the person is fully functional, is under stress, requires treatment or is trying to avoid relapse. The approach has been used to facilitate collaboration between expert clinicians and clergy from a variety of faiths including: Armenian Orthodox; Roman Catholic; Ethical Culture; Hindu; Muslim; Judaism, as well as evangelical and mainline Protestant denominations.



Because clergy tend to see people throughout their lifetimes and in different circumstances, they often are in a better position to identify whether or not someone is functioning properly, Professor Milstein points out. For example, they are likely to distinguish between someone who has lost a loved one and is going through a normal bereavement process and someone who could be clinically depressed. "Recommending an intervention for someone who may be depressed relieves their (clergy) burden," he adds.



Similarly, religious communities can relieve the burden on the clinician by helping people reenter everyday life, Professor Milstein adds. "Religious communities are primary areas of social support for most people. If religion is an important part of an individual's life, the clinician needs to make that connection. They should contact the clergy and let them know to look out for and welcome the person back."



Conversely, he points out that the approach would not be helpful for patients who have had negative associations with religion or religious leaders. "The model is not a panacea, but, rather, an option to engage the whole person. Patients need to be assessed and treated individually without judgments about whether religion is good or bad."



###



Professor Milstein's research collaborators were: Amy Manierre, an American Baptists minister currently pursuing as Master of Social Work Degree at University of Houston; Virginia L. Susman, M.D., Associate Medical Director and Site Director at New York Presbyterian Hospital and Associate Professor of Clinical Psychiatry at Weill Medical College, and Dr. Martha L. Bruce, Professor of Sociology in Psychology at Weill Medical College.



The research was supported by grants from: the DeWitt Wallace-Reader's Digest Research Fellowship Program in Psychiatry; the National Institute of Mental Health; the American Psychological Association and the Professional Staff Congress - CUNY.



About The City College of New York



For more than 160 years, The City College of New York has provided low-cost, high-quality education for New Yorkers in a wide variety of disciplines. Over 14,000 students pursue undergraduate and graduate degrees in the College of Liberal Arts and Sciences; The School of Architecture, Urban Design and Landscape Architecture (SAUDLA); The School of Education; The Grove School of Engineering, and The Sophie Davis School of Biomedical Education. For additional information, visit ccny.cuny.edu/.



Source: Ellis Simon


City College of New York

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Respiratory Syncytial Virus Varies Widely In Season Onsets And Offsets

Investigators are reporting dramatic variability in seasonal onset and offset of respiratory syncytial virus (RSV) outside of presumptive outbreak periods and vicinities.


The findings, based on three-year data from a novel RSV surveillance program known as RSV AlertTM, were released at the 45th Annual Meeting of the Infectious Diseases Society of America (IDSA).


"Our results undermine the popular notion that RSV is predictable in both time period and geography," Jessie R. Groothuis, MD, Vice-President and Head of Medical and Scientific Affairs in Infectious Disease at MedImmune, Inc. in Gaithersburg, Maryland, pointed out.


Importantly, the findings can help practitioners more accurately plan for such outbreaks, she added. "Presently, there is no uniformity in RSV testing," she said. "What's more, local, up-to-date data are not consistently available, specifically regarding the onset and offset of the RSV season. Our RSV surveillance program provides a more accurate retrieval mechanism for RSV detection and should help practitioners make time-sensitive decisions regarding the duration of RSV prevention and management."


The RSV AlertTM program was established to evaluate the variability of the RSV season temporally and geographically in the U.S. by tracking significant (greater than 10% positive levels) activity at the community level with timely reporting, Dr. Groothuis explained.


The program incorporates real-time, weekly reports of RSV tests performed in a majority of Metropolitan Statistical Areas (MSAs) in the U.S.


The present analysis included laboratory RSV testing results collected from September 2004 through May 2007. Sites were recruited according to geographic location and reporting capabilities.


Overall, in the 2006/07 season, approximately 700 sites provided data nationwide, including 39 pediatric centers, representing about 74% of the US population.


During the three-year study period, 185 hospital laboratories showed greater than 10% positivity in either September or October in all regions defined by the Centers for Disease Control (CDC).


The analysis also documented variability in percent positivity for smaller vicinities within a region for the same time period. For example, areas in the Midwest had earlier RSV onsets (September, October) in 2006-2007, while others described later onsets. RSV positivity also tended to vary in the same region from year to year.


"Until now, hospital- and clinic-based practitioners gauge when RSV season is likely to start and end using a CDC databank which provides information on regional but not local levels," Dr. Groothuis said. "The RSV AlertTM program uses highly localized data to provide seasonal detection information which can help practitioners optimize planning for outbreaks in terms of prevention and management."



Finally, she added that the CDC is "so impressed by the results" that it has decided to incorporate data from RSV AlertTM into its own RSV surveillance program on an ongoing basis.


RSV AlertTM is administered and managed by Surveillance Data, Inc. (SDI) in Plymouth Meeting, Pennsylvania, which provides disease surveillance information in several countries worldwide.


Infectious Diseases Society of America


By Jill Stein

Jill Stein is a Paris-based medical writer

Jillstein03 at cs

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Project SEARCH Receives James W. Varnum National Quality Award

The inaugural James W. Varnum National Quality Award was presented to Project SEARCH, a program of Cincinnati Children's Hospital Medical Center (CCHMC), in a ceremony held at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire.



Receiving the award were Project SEARCH co-founder Erin Riehle, MSN, RN, Sr. Clinical Director for Disability Services; and Dr. Linda Workman, Vice President of the Center for Professional Excellence at CCHMC.



The Varnum National Quality Award, named in honor of Jim Varnum, president of Mary Hitchcock Memorial Hospital for more than 28 years, was established by the Dartmouth-Hitchcock Board of Trustees to recognize "an outstanding national leader or team in health care quality improvement initiatives, especially improvements in which patients, families and staff work together to achieve organizational culture change." This inaugural award includes a dynamic, fully produced documentary video about Project SEARCH to serve as an educational tool and to help promote this pioneering program as it continues to evolve.



In presenting the award to Riehle and Workman, Dartmouth-Hitchcock Co-President Dr. James N. Weinstein, observed that Project SEARCH "is a bold, innovative venture that clearly embodies the spirit of Jim Varnum's legacy of service leadership, and the culture he created and fostered at Dartmouth-Hitchcock Medical Center: one of support, respect, and trust."



Since its founding in 1998 by Riehle and Susie Rutkowski, MEd, Project SEARCH has profoundly changed the culture at CCHMC. Through this visionary collaboration among health care, education and support services, many young people with cognitive or physical disabilities (including Down syndrome, Asperger syndrome and other autism spectrum disorders, traumatic brain injury or cerebral palsy), some who are former patients at CCHMC, have found meaningful jobs and more fulfilling lives. Participants not only learn skills that enable them to earn a living income, they also earn respect. Many have been able to move out of their family homes to live independently in the community.



Today, according to Riehle, "We have changed our culture, and we can guarantee that when you walk in that door, you will see somebody working here who looks like you." This has been inspiring especially to families who bring their children with disabilities to CCHMC for care. Project SEARCH has been replicated in more than 150 hospitals, businesses and government agencies, across the U.S. and abroad.



The James W. Varnum Quality Health Care Endowment Fund



Jim Varnum was a visionary health care leader for more than 40 years, an inspiring and bold innovator, and a responsible and responsive member of the national and local health care community.



During his 28 years at the helm of Mary Hitchcock Memorial Hospital, Varnum was an architect of progress for patients, their families, and staff. In recognition of his exceptional service, leadership, and lifelong commitment to quality health care, the Trustees of Mary Hitchcock Memorial Hospital established The James W. Varnum Quality Health Care Endowment. Income from this permanent endowment supports local and national recognition of outstanding leadership in health care quality improvement initiatives.



Varnum retired from Mary Hitchcock Memorial Hospital in April 2006, where he served as president since 1978. In 1983, he founded and was also president of the Dartmouth-Hitchcock Alliance (now the New England Alliance for Health), a group of community hospitals (including Mary Hitchcock), behavioral health centers, and home health care agencies in Vermont, New Hampshire, and western Massachusetts. Previously, he was chief executive officer of the University of Washington Hospital in Seattle and of the University of Wisconsin Hospitals and Clinics in Madison.



Varnum has served on the boards of directors for several state and national organizations. He has earned many awards in recognition of his leadership, including New Hampshire Business Leader of the Year (1992) and American Hospital Association Award of Honor (2006).



Source:

Rick Adams

Dartmouth-Hitchcock Medical Center

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New York Times Examines Debate Over Preimplantation Genetic Diagnosis

The New York Times on Sunday examined the debate over preimplantation genetic diagnosis, a technique that allows physicians to identify embryos without genetic defects or chromosomal abnormalities and then implant the embryos most likely to result in a live, healthy infant. According to the Times, a "growing number of couples" are using PGD to "detect a predisposition to cancers that may or may not develop later in life and are often treatable if they do" (Harmon, New York Times, 9/3). PGD -- which is used during in vitro fertilization -- is an increasingly popular way to ensure a healthy pregnancy for women who have experienced several miscarriages or for couples who are carriers of a genetic disorder. However, some experts urge caution when considering PGD because of a lack of data on the procedure's success and failure rates and long-term health risks for the resulting child. Couples also can use the procedure to select embryos with tissue types identical to those of a severely ill child for whom a perfect tissue match is their only possible treatment (Kaiser Daily Women's Health Policy Report, 11/22/05). According to Salt Lake City-based Myriad Genetics, in the last five years the number of U.S. residents who have been tested for genetic mutations, such as "breast cancer-risk genes" has increased tenfold. An increased "interest in embryo testing is being driven largely by a greater knowledge of genetics among cancer patients and their family members," according to the Times. Some opponents of the procedure believe that its high cost could lead to a "genetic class divide," the Times reports. "From a technology perspective we can test anything," Mark Hughes, director of the Genesis Genetics Institute in Detroit, said, adding, "The issue becomes what is considered serious enough to warrant such testing." Other critics of PGD say that it could be used to select for embryos with "less serious" diseases and characteristics that are "matters of preference," according to the Times. However, proponents of the procedure say that failing to differentiate between people who want to avoid fatal genetic disorders and the concept of "designer babies" is "hurtful and misleading," the Times reports. Because the procedure is not regulated in the U.S., its frequency is unknown (New York Times, 9/3).


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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