Men who have too much calcium in their bloodstreams may have an increased risk of fatal prostate cancer, according to a new analysis from Wake Forest University School of Medicine and the University of Wisconsin.

“We show that men in upper range of the normal distribution of serum calcium subsequently have an almost three-fold increased risk for fatal prostate cancer,” said Gary G. Schwartz, Ph.D., associate professor of cancer biology and of epidemiology and prevention at Wake Forest, a part of Wake Forest University Baptist Medical Center. Such excess calcium can be lowered, he said.

The research appears in the September issue of Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Co-author Halcyon G. Skinner of the School of Medicine and Public Health at the University of Wisconsin stressed there is “little relationship between calcium in the diet and calcium in serum. So men needn’t be concerned about reducing their ordinary dietary intakes of calcium.”

Schwartz and Skinner analyzed the results of 2,814 men who participated in the National Health and Nutrition Examination Survey (NHANES-1). Measurement of the amount of calcium in the bloodstreams was determined an average of 9.9 years before prostate cancer was diagnosed.

The researchers focused on the 85 cases of prostate cancer and 25 prostate cancer deaths among the 2,814 men and divided the group into thirds, based on the serum calcium level. “Comparing men in the top third with men in the bottom third, we found a significantly increased hazard for fatal prostate cancer.

“To our knowledge, this is the first study to examine prostate cancer risk in relation to serum calcium,” Schwartz and Skinner wrote. “These results support the hypothesis that high serum calcium, or a factor strongly associated with it, such as high serum parathyroid hormone, increases the risk for fatal prostate cancer.”

In an interview, Schwartz said that if the relationship between serum calcium and prostate cancer “turns out to be causal, it suggests a means for potentially reducing the risk of fatal disease through medicines that reduce serum levels of calcium and/or parathyroid hormone.”

He added, “Both calcium and parathyroid hormone are known to promote the growth of prostate cancer cells in the laboratory.”

Skinner said, “The take-home message is that this may offer a simple means to detect men who are at increased risk of fatal prostate cancer.”

Schwartz said serum calcium ordinarily is tightly regulated by parathyroid hormone, so there is little variation in an individual’s serum calcium over time. “Calcium is basically the current that runs many of the functions of your body. Calcium is important for not only neuromuscular conductions, electrical conductions, but for the conduction of muscles in your heart.”

Too little calcium in blood, less than 7 milligrams per deciliter, can cause uncontrolled muscular convulsions or contractions. Too much calcium, above 14 milligrams per deciliter, can cause a coma. “Your body obviously cannot afford to oscillate between convulsions and coma, so the range of serum calcium is tightly controlled.”

The upper third of NHANES-1 participants had high normal calcium levels, ranging from 9.9 to 10.5 milligrams per deciliter.

“If confirmed, our study shows that calcium at the high end of normal is associated with a three-fold increased risk of fatal prostate cancer later in life,” Schwartz said. But unlike well-known risk factors for prostate cancer such as age, race or family history, which cannot be altered, “a man’s serum calcium levels can be.”

Several drugs already used in patients with high levels of parathyroid hormone, such as patients with chronic kidney disease, could be used to reduce calcium and/or parathyroid hormone in the blood, he said.

Measurements of serum calcium are routinely collected and are part of most medical visits. Thus, a physician can readily determine whether a man’s serum calcium level is at the high end of normal.

“What is particularly exciting if this study is replicated, and attempts to do so are already in progress is that it suggests that a man may reduce his risk of fatal prostate cancer by lowering serum levels of calcium and/or parathyroid hormone,” he said.

Wake Forest University Baptist Medical Center (wfubmc) is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children’s Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university’s School of Medicine and Piedmont Triad Research Park. The system comprises 1,154 acute care, rehabilitation and long-term care beds and has been ranked as one of “America’s Best Hospitals” by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America’s Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.

Wake Forest University Baptist Medical Center
Medical Center Blvd.
Winston-Salem, NC 27157-1015
United States
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OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced that it has initiated a first-in-human clinical study for its G-protein coupled receptor GPR119 agonist, PSN821, which the Company is developing for the treatment of type 2 diabetes. Discovered by OSI’s diabetes and obesity research team, PSN821 demonstrated both effective glucose lowering and substantial reductions of body weight in pre-clinical studies. Pre-clinical data on PSN821 was the subject of an oral presentation at this year’s American Diabetes Association meeting in San Francisco, CA in June. PSN821 is the third development candidate discovered in-house that the Company has moved into clinical development this year. PSN602, OSI’s first anti-obesity agent to enter the clinic commenced a Phase I trial in June and OSI-027, the Company’s anti-cancer TORC1 and TORC2 inhibitor began a Phase I trial in July.

“We are encouraged by the dual profile which has been observed for PSN821 and believe that it has the potential to be the first orally available therapy for type 2 diabetes that delivers both glucose control and substantial weight loss,” stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. “PSN821 and our anti-obesity agent, PSN602, are part of an innovative strategy to discover and develop differentiated molecular targeted therapies for the treatment of type 2 diabetes and obesity.”

About the Study

The double-blind, placebo-controlled, ascending single oral dose study is designed to provide preliminary information on the safety, tolerability and pharmacokinetics of PSN821 in healthy lean and overweight/obese subjects and patients with type 2 diabetes, as well as provide preliminary information on the effects of PSN821 on acute glucose control in the patient group.

Background on PSN821

PSN821 is a novel, orally available agonist of the G-protein coupled receptor GPR119 which stimulates the release of both insulin and glucagon-like peptide-1 (GLP-1). In pre-clinical studies, PSN821 has demonstrated pronounced glucose lowering in rodent models of type 2 diabetes with no loss of efficacy on repeated administration, and substantial reductions of body weight in rodent models of obesity. In male diabetic ZDF rats, both acute and chronic oral administration of PSN821, significantly and dose-dependently reduced glucose excursions in an oral glucose tolerance test. In prediabetic male ZDF rats, daily oral dosing of PSN821 for 8 weeks significantly lowered nonfasting blood glucose concentrations and HbA1c levels compared to vehicle. Furthermore, in weight-stable, dietary-induced obese (DIO) female Wistar rats, daily oral dosing of PSN821 for 4 weeks reduced body weight substantially and significantly by 8.8%, approaching the 10.6% weight loss induced by a high dose of the prescribed anti-obesity agent sibutramine.

About OSI Pharmaceuticals

OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The Company’s oncology programs are focused on developing molecular targeted therapies designed to change the paradigm of cancer care. OSI’s diabetes/obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva® (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients in certain settings. OSI markets Tarceva through partnerships with Genentech, Inc. in the United States and with Roche throughout the rest of the world. For additional information about OSI, please visit osip.

This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the results from, and the ability to complete, clinical trials, the FDA review process and other governmental regulation, OSI’s and its collaborators’ abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in OSI Pharmaceuticals’ filings with the Securities and Exchange Commission.

OSI Pharmaceuticals

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There will be a new drive to ensure GPs spot cervical cancer symptoms earlier in young women and refer patients correctly, Health Minister Ann Keen announced today.

The review, carried out by the independent Advisory Committee on Cervical Screening (ACCS) reported concern that young women who present to their GPs with cervical cancer symptoms are not always being given appropriate advice and have recommended immediate action in this area including:

- New guidance on the management of young women with gynaecological symptoms and an audit of young women diagnosed with cervical cancer.
- An awareness campaign for GPs and practice nurses.
- An audit of all young women diagnosed with cervical cancer looking at their symptoms prior to diagnosis.
- Expand work to increase screening uptake in women aged 25 to 34.

The ACCS also agreed unanimously for no change in the screening age as evidence showed that earlier screening could do more harm than good causing too many false positives and increase the risk of premature births in some women.

Health Minister Ann Keen said:

“In the past few months I have met with a number of young women who have cervical cancer. I have listened carefully and I am determined to make sure that our policy is in their best interests.

“That is why I asked the ACCS to carry out a review into the cervical screening age because I wanted to make sure that our guidelines are based on the latest available clinical evidence.

“They have concluded that the screening age should not be lowered but have recommended that we do more work around the treatment of symptomatic patients. I fully support this conclusion and look forward to beginning this important new work to ensure women with cervical cancer are diagnosed at the earliest possible opportunity.

“There has been a big public debate about this issue and a great deal of publicity about the causes and symptoms of cervical cancer. Together we can build on this work to help even more women across the country to take steps to prevent the disease and to identify symptoms early and save lives.”

ACCS Chairman Professor Henry Kitchener said:

“The Committee were unanimous in their decision not to lower the screening age below 25.

“This decision was taken because scientific evidence shows that screening women in this age group can do more harm than good.

“However we are concerned that young women with gynaecological symptoms are not always being given the right advice from their GPs and we will ask the Department of Health to take action.”

National Director for Cancer Professor Mike Richards said:

“The ACCS has done a very through job and I thank them for their work and fully agree with their recommendations.

“Importantly The ACCS has identified the need for urgent action on young women who present to their GPs with gynaecological symptoms. We know that early diagnosis is key to improving survival chances.

“We will develop guidance to support GPs and practice nurses so that young women with cervical cancer are diagnosed at the earliest opportunity.”

The ACCS will now consider ways to improve the way symptomatic patients are treated, with a particular focus on women under 25 and then make further recommendations to the Department of Health.

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The National Institute for Health and Clinical Excellence (NICE) and the National Collaborating Centre for Mental Health have today (28 September) launched a clinical guideline on the treatment and management of depression in children and young people. The guideline recommends that -

• Children and young people with moderate to severe depression should be offered, as a first-line treatment, a specific psychological therapy (such as cognitive behavioural therapy, interpersonal therapy or family therapy of at least 3 months’ duration).

• Antidepressant medication should not be offered to children or young people with moderate to severe depression except in combination with a concurrent psychological therapy and should not be offered at all to children with mild depression.

• Healthcare professionals in primary care, schools and other relevant community settings should be trained to detect symptoms of depression, and to assess children and young people who may be at risk of depression.

• Attention should be paid to the possible need for parents’ own psychiatric problems (particularly depression) to be treated in parallel, if the child or young person’s mental health is to improve.

Andrew Dillon, Chief Executive of NICE and Executive Lead for this guideline says “This guideline makes it clear that psychological treatments are the most effective way to treat depression in children and young people. It’s important that children and young people taking anti-depressants do not stop taking them abruptly, but we would advise people to talk to their GP at their next regular review about whether a psychological treatment may be a more effective treatment option.”

Dr Tim Kendall, Joint Director of the National Collaborating Centre for Mental Health who developed the guideline on behalf of NICE says “This is the sixth mental health guideline where we have recommended psychological treatments as key treatments for a mental health condition and the third where we have recommended them as the first line treatment. The evidence supporting these treatments is robust and it is vital that the NHS provides psychological therapies to ensure everyone who needs these treatments can access them rapidly.”

Professor Peter Fonagy, Professor of Psychoanalysis and Chair, Guideline Development Group says “Depression in children is more common than many people realise and often goes unrecognised. Around 1% of children and 3% of adolescents will suffer from depression in any one year. It can severely impact on school performance, self esteem and making and retaining friendships. It can lead to a greatly increased risk of mental health problems in adult life and at its most serious it can dramatically increase the lifetime risk of suicide, from 1.3% in the general population to 6%.”

Ms Charlotte Dodds, Depression Support Group Co-Facilitator and Carer Representative on the Guideline Development Group says “Depression disproportionately affects the most disadvantaged children. Children and young people with emotional disorders, when compared with children without a mental disorder, were nearly twice as likely to be living with a lone parent (28% versus 15%), more than twice as likely to be with both parents being unemployed (27% versus 12%), and more likely to have parents who were on low incomes, had fewer qualifications and living in social sector housing. I hope this guideline raises awareness of the issue and encourages more equal access to treatments for all children and young people with depression, no matter where or how they live.”

Ms Dinah Morley, Deputy Director of YoungMinds says “YoungMinds welcomes the emphasis on psychological therapies as the best approach to the treatment of depression. However the very significant shortage of practitioners able to deliver these therapies is a cause for concern, as is the general lack of awareness of the prevalence of depression in babies, children and young people. We look to increasing investment in services which support the mental health of children and young people and to improvements in the training of all practitioners working with children, to help them in identifying symptoms of depression and in seeking effective help. Too many children’s lives are blighted by depression, a condition for which there are effective treatments. We welcome the NICE guidelines as another reminder that children’s mental health matters and is the business of everybody.”

The Committee on the Safety of Medicines issued advice on the safety of antidepressant medication for children in 2003. The NICE guidance complements and builds on this advice.

About NICE

1 On 1 April 2005 the National Institute for Clinical Excellence took on the functions of the Health Development Agency to form the National Institute for Health and Clinical Excellence (NICE). NICE is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

2 NICE produces guidance in three areas of health:
_ public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
_ health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS
_ clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

About Yound Minds

1 YoungMinds is the national charity committed to improving the mental health of all children and young people.
The YoungMinds Parents’ Information Service (0800 018 2138) provides information and
advice for anyone with concerns about the mental health of a child or young person.

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Takeda Pharmaceutical Company
Limited (“Takeda,” Osaka, Japan) and BioNumerik Pharmaceuticals, Inc.
(“BioNumerik”, San Antonio, Texas) today announced the results of two Phase
III Trials for Tavocept(TM). Tavocept is an investigational new drug with
potential for oncology and non-oncology indications that was originated and
developed by BioNumerik.

The initial development focus for Tavocept has been as an
investigational new drug to prevent or mitigate the peripheral nerve
damage, or neuropathy, that is known to be associated with certain commonly
used classes of chemotherapy drugs, such as taxane and platinum agents.
Data was recently unblinded by BioNumerik from two placebo controlled
Tavocept Phase III clinical trials consisting of (1) a Phase III trial of
weekly administration of paclitaxel (a widely used taxane drug) to patients
with metastatic breast cancer enrolled from the United States, Russia, and
Ukraine (the “Weekly Paclitaxel Breast Cancer Trial”); and (2) a Phase III
trial involving administration of paclitaxel and cisplatin (a widely used
platinum drug) every 3 weeks to patients with non-small cell lung cancer
from Eastern and Western Europe (the “European Lung Cancer Trial”). Both of
these trials were aimed at evaluating Tavocept’s potential for a neuropathy
related treatment indication.

Each of the Phase III trials was designed as a randomized double-blind
placebo controlled trial with each patient to be randomly assigned to
receive either Tavocept or placebo in conjunction with chemotherapy. The
primary endpoints for the Weekly Paclitaxel Breast Cancer Trial and the
European Lung Cancer Trial were: (1) the total incidence of severe
neuropathy caused by the administration of chemotherapy in combination with
Tavocept or placebo; and (2) the difference in rates of tumor shrinkage in
patients receiving chemotherapy in combination with Tavocept or placebo, in
order to determine whether Tavocept has an impact on the anti-tumor effect
of chemotherapy.

Based on review and analysis of the results, the trials did not meet
their primary endpoints and they were inconclusive in terms of
demonstrating a statistically significant effect of Tavocept in reducing
the incidence of severe neuropathy caused by the administration of
paclitaxel and/or cisplatin. In addition, neither of the trials
demonstrated a statistically significant finding in terms of objective
tumor response rate or tumor protection as assessed in accordance with the
predefined statistical analysis plans for the trials, or by an independent
radiological review committee.

In commenting on the data, Frederick H. Hausheer, M.D., Chairman and
Chief Executive Officer of BioNumerik stated, “Many patients suffer from
chemotherapy induced neuropathy and there is no FDA-approved treatment to
prevent or reduce neuropathy caused by taxane and platinum chemotherapy
drugs. Although we did not see the results that we hoped to observe in
these Phase III trials, we believe there is evidence of potential clinical
activity of Tavocept that supports consideration of possible further
Tavocept development aimed at addressing the large unmet medical need for
neuroprotective agents. Certain trends and subgroup analyses for the trials
indicate that Tavocept may have potential for reducing chemotherapy-induced
neuropathy that merits consideration of further clinical testing. In
addition, the way that neuropathy was measured and the countries where the
trials were conducted may also have impacted the results.”

Subgroup analysis by country from the Weekly Paclitaxel Breast Cancer
Trial revealed a notable finding in favor of Tavocept in the reduction of
patient-reported severe neuropathy (as measured by Patient Neurotoxicity
Questionnaire (PNQ) grades D or E) for patients enrolled only from U.S.
sites. In this subpopulation comprising patients enrolled only from U.S.
sites, the incidence of patient-reported severe neuropathy confirmed for at
least 4 weeks (PNQ grades D or E) was 3.2% in the Tavocept group as
compared to 20.0% in the placebo group. This observation represents an 84%
lower incidence of severe neuropathy in favor of Tavocept. The Patient
Neurotoxicity Questionnaire (or PNQ) is a patient-based neuropathy
measurement tool that was used to measure neuropathy in the Tavocept Phase
III trials. The National Cancer Institute Common Toxicity Criteria
(“NCI-CTC”), a physician-based neuropathy measurement tool, showed a
consistent trend with that of the PNQ in terms of comparing the overall
severe neuropathy reported in the Tavocept and placebo arms for patients
from U.S. sites in the Weekly Paclitaxel Breast Cancer Trial. However, it
is also important to note that only about 8% of the total number of
patients treated in the Weekly Paclitaxel Breast Cancer Trial were treated
at U.S. clinical sites.

“An important factor supporting possible future Tavocept development
for a neuropathy indication is the subgroup analysis for patients enrolled
only at clinical sites located in the United States who participated in the
Weekly Paclitaxel Breast Cancer Trial,” said Hausheer. “We also observed
some encouraging trends in the Weekly Paclitaxel Breast Cancer Trial that
indicate potential activity of Tavocept in reducing moderate to severe
neuropathy. These are some of the first Phase III trials conducted to
assess the potential reduction of chemotherapy induced neuropathy. We
believe there may be modifications in the trial endpoints in the future as
well as changes in the procedures for assessing neuropathy in order to
clinically assess patients at risk for this complication and to address
some of the technical challenges we have observed in these trials to date.
While we are encouraged by some of the observations in these trials, it is
clear that additional clinical testing will be required to support
development of Tavocept for a neuropathy indication.”

Takeda has notified BioNumerik that, given the additional time
necessary to conduct additional clinical testing for a Tavocept neuropathy
indication, one possible alternative is termination of the existing
Tavocept License and Development Alliance Agreement between Takeda and
BioNumerik for the United States and Canada. Takeda and BioNumerik are
continuing to discuss the data from the trials as well as considerations
regarding the alliance agreement and the future development of Tavocept.

About Tavocept:

Tavocept is an investigational new drug with potential for oncology and
non-oncology indications that was originated and developed by BioNumerik.
Tavocept has potential applicability in multiple therapeutic areas
including diabetic neuropathy, protection against toxicity from radiation
therapy, lymphedema and other potential medical indications. In addition to
chemotherapy induced neuropathy, BioNumerik is evaluating further Tavocept
development possibilities in these areas.

About Takeda:

Takeda, located in Osaka, Japan, is a research-based global company
with its main focus on pharmaceuticals. As the largest pharmaceutical
company in Japan and one of the global leaders of the industry, Takeda is
committed to striving toward better health for individuals and progress in
medicine by developing superior pharmaceutical products. Additional
information about Takeda is available through its corporate website,
takeda/index-e.html.

About BioNumerik:

BioNumerik, headquartered in San Antonio, Texas, is a pharmaceutical
company focused on the discovery, development and commercialization of
novel drugs for the treatment of patients with cancer. BioNumerik has two
drug candidates in late-stage clinical development: Tavocept(TM) and
Karenitecin (BNP1350).

BioNumerik Pharmaceuticals; Takeda Pharmaceutical Company
takeda/index-e.html Continue reading →

The University of Alabama at Birmingham (UAB) Comprehensive Cancer Center commemorated the signing of legislation requiring the Alabama Department of Public Health to create breast, cervical and colorectal cancer screening programs designed to save the lives of thousands of Alabamians in an event held May 19.

Cancer Center Director Edward Partridge, M.D., president-elect of the American Cancer Society (ACS) National Board of Directors, and State Rep. Paul DeMarco (R) of Homewood were featured speakers. Representatives from various cancer organizations, as well as many cancer patients and survivors, were on hand for the commemoration, which included a video of prepared remarks by Gov. Bob Riley. Riley signed the legislation in advance of the event, which he was originally planning to attend; the Gulf oil spill situation dictated a change in the governor’s schedule.

The new act, which originated in House Bill 600, gives statutory authority for breast, cervical and colorectal cancer screening programs to the Department of Public Health. Experts say the life-saving practice of expanding proven cancer screening programs benefits everyone, especially the medically under-served and the uninsured.

“We have a responsibility to do the right thing, and this act makes breast, cervical and colorectal cancer prevention and awareness a vital part of our state’s anti-cancer policy,” Riley said. “Since these forms of the disease are treatable and curable if they’re caught early enough, a vital screening program deserves our full support.”

Approved by the Alabama Legislature earlier this year, the act also supports raising public awareness about cancer prevention and detection as a responsible and cost-effective health measure. It formalizes the collection and research value of confidential health data gathered on breast, cervical and colorectal cancer prevention and incidence.

“It is tragic when cancer causes the loss of a life, and to me it’s completely unnecessary when upward of 70 percent of all cancer deaths can be prevented through screening and early detection,” Partridge said, praising the new act and the many academic, legislative, public health, business and nonprofit leaders who advocated for the legislation.

The act was authored by DeMarco after he worked with Partridge, representatives from ACS, the University of South Alabama (USA) Mitchell Cancer Institute and many of those attending the signing ceremony to host the “Alabama Cancer Summit 2009: A Call to Action.” The event was held last May at the Birmingham-Jefferson Convention Complex.

DeMarco said it became obvious during last year’s summit and through regular discussions with public-health officials that enacting such a law could lead to improved support for these screenings. “I am optimistic this legislation will reduce the state’s high cancer death rate,” he said.

Data show that an estimated 22,000 new cancer cases occurred in Alabama last year, and that nearly 10,000 Alabamians died from the disease. Experts say those numbers could be reduced by broadening access to cancer screening programs, delivering the message of healthy lifestyle changes and advocating for timely and effective cancer treatment.

During the May 19 commemoration, speakers also kicked off Birmingham’s inaugural survivors day event “Celebrating Life” set for June 5 at Pepper Place Saturday Market. A designated National Cancer Survivors Day event, Celebrating Life will take place from 7 a.m. to noon during the Saturday Market at 2829 2nd Ave. South. Riley signed a proclamation in advance declaring June 5 as National Cancer Survivors Day in the state.

About the UAB Comprehensive Cancer Center

The UAB Comprehensive Cancer Center is among the 40 cancer centers in the nation to meet the stringent criteria for the National Cancer Institute’s comprehensive designation. The center is a leader in groundbreaking research, reducing cancer disparities and leading-edge patient care.

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University of Alabama at Birmingham (UAB) Continue reading →

The National Alliance on Mental Illness (NAMI) praises a new report, Caregiving in the U.S. 2009, which offers a revealing portrait of the nearly one-in-three American adults who serve as a family caregiver.

The study is based on interviews with 1,480 caregivers chosen at random and offers a national profile of people caring for adults, the elderly and children with special needs. It follows similar studies conducted in 2004 and 1997, but for the first time, caregivers for children, as well as those caring for adults over the age of 18, were surveyed.

The report echoes the findings of NAMI’s own depression survey and schizophrenia survey, which include the perspective of caregivers for people living with these serious mental illnesses. All these reports suggest that caregivers face daily stresses that can impact their own health and other relationships. For example, NAMI’s depression survey, released in November, found that while almost one-half (48 percent) of caregivers for people with depression have been diagnosed with depression themselves, only about 25 percent were engaged in treatment at the time of the survey.

“We know from our own studies that caregivers make significant sacrifices to care for their loved ones living with mental illness,” said Michael Fitzpatrick, NAMI executive director. “The findings of this new report will help us anticipate the needs of caregivers so that we can improve NAMI’s education and support programs.”

NAMI offers a variety of peer education and support programs, including those specifically for caregivers.

Family-to-Family is a free, twelve-week course for family caregivers of individuals with severe mental illnesses. The course is taught by trained family members and more than 115,000 family members have graduated from this national program. The course is also available in Spanish.

NAMI Basics is an education program for parents and other caregivers of children and adolescents living with mental illnesses. The course is taught by trained teachers who are the parent or other caregivers of individuals who developed the symptoms of mental illness prior to the age of 13 years.

Source
National Alliance on Mental Illness Continue reading →

Max Neeman International, a leading Indian CRO, has formed an exclusive team of India’s finest, most experienced Physicians to conduct Minimally Invasive Surgery Studies. The team consists of the best Minimal Access Surgeons in the country who have performed more than 25,000 procedures combined.

Having already conducted multiple Minimally Invasive Device Trials for top device companies, the new specialized team adds another level of Company expertise for conducting Minimally Invasive Surgical Studies across multiple therapeutic areas. Patient numbers have been as high as 300 with major focus on peripheral vascular disease, gastric surgery and laparoscopy.

Max Neeman International’s partner, Max Healthcare has over 800 beds and 12 hospitals throughout the country and is one of the leading hospital chains in India with an outstanding reputation and track record for quality health care.

About Max Healthcare

With over 800 beds, 12 hospitals, 1500 physicians and 3000 support staff – Max Healthcare is one of a leading chain of hospitals in India. Its state of the art infrastructure, over 225 ICU beds and most advanced technologies makes it one of the best hospitals in India.

About Max Neeman International

Max Neeman International is one of the leading and largest CROs in India. Our specialty is that we offer services for the successful conduct of Phase II-IV clinical and device trials for small and mid-sized international and national Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies in compliance with ICH GCP standards. Operational since 2001, Max Neeman is an ISO 9001:2000 certified CRO for Monitoring, Site Management and Data Management Services. The company is presently active in 22 cities with 5 regional offices.

Continue reading →

Greyson International, Inc. (GYSN.PK) announced that it has received results from a third-party clinical study conducted on Trilexon®, a new delivery system designed by Greyson that improves the effectiveness of topical applications. Trilexon® Line Smoother, Trilexon® Eye Cr??me and Trilexon® Night Cr??me are the first skincare products to utilize the unique delivery system, which precisely delivers key ingredients to the appropriate areas through “messengers” in order to achieve higher effectiveness and more noticeable results.

“We are proud to announce the success of Trilexon® in a third-party clinical study,” said Greyson International CEO Harvey Tauman. “These findings validate what we have believed from the beginning-that Trilexon® is the latest and most effective technology to be introduced in the skincare market. This clinical study proves that Trilexon® delivers extraordinary results, above and beyond existing delivery systems found in today’s topical applications.”

The clinical study reviewed four different points, including Ph levels to determine the effectiveness of the delivery system, protein and skin lipid levels to determine the length of time the delivery system remains on the skin, time release of ingredients on the skin and skin barrier penetration of ingredients. On all four points, Trilexon® performed to the highest level, confirming that it is effective, remains on the skin, releases ingredients over time and penetrates the skin barrier to deliver active ingredients efficiently.

The independent study on Trilexon® was performed by Dr. Peter Pugliese, a world-renowned physician who has spent over 25 years studying specializing in aging mechanisms of human skin. Dr. Pugliese holds several patents, has published hundreds of articles and has lectured on every continent. He was awarded the Maison De Navarre Award for his contributions to cosmetic science. Dr. Pugliese has authored the textbook series Physiology of the Skin, which is a standard esthetic student reference. His latest textbook, Advanced Professional Skin Care, Medical Edition, replaced other teaching materials and has grown in use on a global level.

“As a chemist who has worked in the beauty and skincare industry for over 40 years, I am confident in stating that Trilexon® is one of the most significant advancements in delivery system technology that we have seen in decades,” said Charles Fox, head of research and development for Greyson International. “The results from this clinical study provide us with the scientific evidence that we need to authenticate its effectiveness as we move forward and market Trilexon® through our own products and through licensing opportunities to beauty, skincare, health and pharmaceutical companies around the world.”

Trilexon® also recently received trademark approval. Greyson International received confirmation that it is safe for use based on thorough safety testing on an independent panel of participants.

Source
Greyson International, Inc. Continue reading →

A Finnish study of identical twins has found that physical inactivity and acquired obesity can impair expression of the genes which help the cells produce energy. The findings suggest that lifestyle, more than heredity, contributes to insulin resistance in people who are obese. Insulin resistance increases the chance of developing diabetes and heart disease.

The study, “Acquired obesity and poor physical fitness impair expression of genes of mitochondrial oxidative phosphorylation in monozygotic twins discordant for obesity,” appears in the online edition of the American Journal of Physiology-Endocrinology and Metabolism, published by The American Physiological Society (the-aps/).

The study was carried out by Linda Mustelin and Kirsi Pietil?¤inen, of Helsinki University Central Hospital and the University of Helsinki; Aila Rissanen, Anssi Sovij?¤rvi and P?¤ivi Piiril?¤ of Helsinki University Central Hospital; Jussi Naukkarinen, Leena Peltonen and Jaakko Kaprio, University of Helsinki and National Public Health Institute; and Hannele Yki-J?¤rvinen of Helsinki University Central Hospital and Minerva Medical Research Institute.

Environment can influence genes

Recent studies have suggested that defects in expression of genes involved in the body’s conversion of food to energy, known as mitochondrial oxidative phosphorylation, can lead to insulin resistance. The researchers wanted to know if defects in the expression of these genes are primarily a result of heredity or lifestyle. Because the twins in the study were identical, any differences that were found could be attributed to environmental factors, the researchers reasoned.

Twenty four pairs of identical twins, born in Finland between 1975 and 1979, took part in the study. Fourteen pairs (eight male and six female) were discordant for obesity, that is, one twin was obese, while the other was not. The control group consisted of five male and five female twin pairs who were concordant for weight. Some of the concordant pairs were normal-weight while some pairs were overweight.

The researchers measured whole body insulin sensitivity, body composition and cardiorespiratory fitness. They also obtained a needle biopsy of abdominal subcutaneous fat tissue, although they were unable to obtain this measurement for one of the discordant pairs.

Among the discordant pairs, the study found the obese twin had significantly lower:
Insulin sensitivity, indicating the body has a harder time using glucose to produce energy.
vFitness levels, as measured by maximum oxygen uptake and maximum work capacity.

Transcription levels of genes that help cells convert food to energy (the genes of mitochondrial oxidative phosphorylation). Transcription is a multi-step process in which information in the genes is used to manufacture proteins. Proteins, in turn, direct cell activity. This suggests that the impaired expression of the genes may make it more difficult to lose excess weight, or may make additional weight gain more likely.

Heredity may still play role

“These data suggest that physical inactivity may have contributed to the defects in mitochondrial oxidative phosphorylation described in type 2 diabetic patients and prediabetic subjects,” the authors wrote. The authors also noted that, although environment plays a role in how these genes work, there still may be a hereditary component.

“Although we found that the reduced transcript levels of genes encoding mitochondrial oxidative phosphorylation in obesity is influenced by environmental and acquired factors, it does not exclude the possibility that genetic factors contribute to regulation of mitochondrial oxidative metabolism,” lead author Linda Mustelin noted.

The next step is to do a clinical study to see if exercise and other lifestyle changes can increase the expression of these genes.

Physiology is the study of how molecules, cells, tissues and organs function to create health or disease. The American Physiological Society (the-aps/press) has been an integral part of this discovery process since it was established in 1887.

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