2009 Julio

As part of its study of how much vitamin D and calcium people need, a committee convened by the Institute of Medicine will hold a public workshop to gather insights and data from experts on Tuesday, Aug. 4. Among the workshops presentations will be a discussion of a recent vitamin D and calcium report released by the Agency for Healthcare Research and Quality, which can be found at ahrq.gov/clinic/tp/vitadcaltp.htm. A workshop agenda with a list of presentations is available at iom.edu/?id=68400.

The workshop will run from 8 a.m. through 5 p.m. in Room 100 of the National Academies Keck Center, 500 Fifth St., N.W., Washington, D.C. Due to space limitations, advance registration is required.

Source
Christine Stencel

A new study published in a leading medical journal today shows that in Western Cambodia, the parasites that cause malaria have developed resistance to first line drugs, thus reducing their effectiveness and potentially putting at risk the lives of millions of people.

The study, which was funded by the Global Malaria Programme of the World Health Organisation, the Wellcome Trust and the Li Ka Shing Foundation, was the work of researchers from the WellcomeMahidol University Oxford Tropical Medicine Research Programme, based in Bangkok, Thailand, and colleagues at other research centers, and is published in the 30 July issue of the New England Journal of Medicine, NEJM.

The Research Programme in Bangkok is a collaboration between Mahidol University, Bangkok, and the University of Oxford, supported by the Wellcome Trust. The WHO Programme funds came from grants provided by the Melinda Gates Foundation and the Western Pacific Regional Office.

Malaria is a potentially fatal disease that kills more than a million people every year; mostly young children and pregnant women. The disease is caused by a parasite called Plasmodium that enters the bloodstream or lymphatic system of humans via bites from the parasitecarrying Anopheles female mosquito.

The most deadly form of malaria is caused by the parasite Plasmodium falciparum which kills 9 out of 10 of the people it infects.

The recommended first line treatment for P. falciparum malaria is combination therapies that use drugs derived from artemisinin which comes from the sweet wormwood plant (Artemisia annua) used by practitioners of Chinese medicine for centuries under the name Qinghaosu.

Drugs based on arteminisin are considered better than other antimalaria drugs like chloroquine and mefloquine because, until now, malaria parasites appear unable to resist it.

However, recent reports from the ThaiCambodian border, where resistance to antimalaria drugs has occured a number of times before, suggest that a strain of malaria parasite is emerging that is resistant to artemisininbased drugs.

The authors decided to investigate this further by conducting two openlabel (that is unlike a blinded trial, doctors and patients knew which drugs they were getting) randomized trials to compared the effectiveness of two antimalaria treatments in two groups of 40 patients.

One group of patients was in Pailin, western Cambodia, and the other was in Wang Pha, northwestern Thailand.

Each patient received the relevant dosage appropriate to their body weight of either artesunate or a combination of artesunate and mefloquine. (Artesunate is an artemisinin derivative). Thus 20 patients in each country received monotherapy (artesunate on its own) and 20 received combination therapy.

The results showed that on average, the patients in Thailand were clear of the parasite within 48 hours, but in western Cambodia it took nearly twice as long for the parasite to clear there it took 84 hours.

Another way to test for drug resistance is to see if the disease recurs after treatment. If the drug is effective, the number of parasites should fall during the treatment period and the infection should clear.

In the trials the researchers found that among the patients in each country who received monotherapy, infection recurred in 6 out of 20 patients in western Cambodia and in only 1 of the 20 patients in Thailand.

Similarly, of the 20 patients in each country who were treated with combination therapy, infection recurred in 2 in Cambodia compared with only 1 in Thailand.

Lead author Dr Arjen Dondorp of the Faculty of Tropical Medicine at Mahidol University told the media that

“Our study suggests that malaria parasites in Cambodia are less susceptible to artemisinin than those in Thailand.”

“This means that it takes longer to kill the parasites,” added Dondorp, explaining that

“Artemisinin should clear the parasites at an early stage, preventing them further maturing and reproducing. When the drugs action is impaired, it becomes more difficult to eliminate the parasites from the body.”

As the artemisinin derivative loses its potency, artemisininbased combination therapies (ACTs) begin to rely increasingly on the weaker partner drug, which increases the chance that resistance will also evolve toward the partner drug.

“This has very important consequences for the lifespan of ACTs. Losing ACTs would be a disaster for malaria control,” warned Dondorp.

Speculating on what may have caused this decrease in suscpetibility, there are a number of possible contributing factors, although the study iteself did not examine them.

One is the fact that western Cambodia has relied on artemisininbased drugs for the last 30 years and was one of the first to use ACTs in 2001.

But unfortunately a big problem is the relatively unregulated private sector from which many patients in the region get their antimalaria drugs, which are often obtained as monotherapies and the treatment courses are often not completed.

Add to this the problem of counterfeit and substandard drugs with insufficient quantities of artemisinin, and you have a high risk scenario for the emergence of drugresistant forms of malaria.

Whatever the reason, there are also signs that artemisininresistance is spreading to other parts of Cambodia and Thailand, and Dondorp says there is no time to waste we have to act swiftly.

“Preventing the spread of resistant parasites when they emerge is crucial,” said Dondorp.

“The use of combination therapies is very important for this. I would like to see a ban on artesunate monotherapy except for specific cases,” he added.

Coauthor Professor Nick White, Chair of the Wellcome Trust SouthEast Asia Programme, said the study points to potentially devastating consequences

“Artemisinins are essential weapons in our war against malaria,” he said, and if they become ineffective

“Elimination of malaria will not be possible and millions of lives could be lost.”

“Artemisinin Resistance in Plasmodium falciparum Malaria.”
Dondorp, Arjen M., Nosten, Francois, Yi, Poravuth, Das, Debashish, Phyo, Aung Phae, Tarning, Joel, Lwin, Khin Maung, Ariey, Frederic, Hanpithakpong, Warunee, Lee, Sue J., Ringwald, Pascal, Silamut, Kamolrat, Imwong, Mallika, Chotivanich, Kesinee, Lim, Pharath, Herdman, Trent, An, Sen Sam, Yeung, Shunmay, Singhasivanon, Pratap, Day, Nicholas P.J., Lindegardh, Niklas, Socheat, Duong, White, Nicholas J.
N Engl J Med, Volume 361, Number 5, pp 455467, July 30, 2009.

Additional source Wellcome Trust .

Written by Catharine Paddock, PhD

New research released by the Royal Pharmaceutical Society of Great Britain (RPSGB) reveals how older people are taking a cocktail of medicine without fully understanding what they are or the side effects they are causing.

The RPSGB survey shows that nearly half (43%) of over 65s are currently taking over five medicines at any one time. However, one in five admits to not always taking the medicine as prescribed. Sixty per cent also believe that they either definitely or possibly have had a side effect from medicine yet one if five said they did not get it checked out.

In response to these findings, the RPSGB is launching a campaign to urge older people to review the medicine they are taking by visiting their local pharmacist for a Medicine Use Review (MUR).

MURs are undertaken by local pharmacies to help patients manage their medicine more effectively and can be done on an annual basis. It involves a consultation with a pharmacist and can be offered to anyone on one or more medicines and/ or long term conditions.

Royal Pharmaceutical Society spokesman and pharmacist, Paul Johnson says; “Its not unusual for older people to get confused with the medicine they are taking, particularly when they are on numerous types of medication. As a result, they may also not realise the reactions they may be causing when they are not used properly.

“Pharmacists are easily accessible and are ideally placed to provide advice to a patient on their medicine which can really improve someones health or even their quality of life. “

Other findings of the research revealed that almost one in 10 (9%) admit to not fully understanding what their medications do or how they treat their condition, and one in seven (14%) say they sometimes forget to take a pill at the recommended time.

The New York Times profiles Pashtoon Azfar, the director of Afghanistans Institute of Health Sciences, who works for a nonprofit group from Johns Hopkins University that focuses on women and childrens health, and “also manages to serve as president of the Afghan Midwives Association.” Azfar was the “star” of a recent Capitol Hill briefing about maternal health in Afghanistan.

Despite Afghanistan having “the worlds secondhighest death rate in women during pregnancy and childbirth,” at the briefing Azfar “ran through statistics showing notable increases recently in the countrys number of midwives, their education and the percentage of women who give birth with the help of a skilled attendant, usually a midwife. The U.S., the World Bank, the European Commission, UNICEF, the Hopkins group (known as Jhpiego) and other donors have all helped Afghanistans Ministry of Public Health to make improvements,” according to the New York Times.

Although there has been some progress, “there is a long way to go,” the New York Times writes, noting that up to 80 percent of women in Afghanistan “still give birth without skilled help, and only a third receive any medical care at all during pregnancy.” The countrys problems “mirror those of many other poor countries,” while “deeper problems are cultural, rooted in the low status of women and the misperception that deaths in childbirth are inevitable,” according to the newspaper.

After leaving Afghanistan for more than a decade, Afzar said when she returned in 2003, the state of midwifery was a mess. “A culture of war was going on,” Azfar said, adding, “If a mother came for delivery they didnt treat her as she deserved or needed to be treated. There was no emotional support.” She “acknowledged that it was hard to change attitudes, but she insisted that it could be done, by making interpersonal skills part of the training and the tests that students must pass to be allowed to practice,” writes the New York Times. The article includes more detail about Azfars life and early training (Grady, 7/27).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Scientists in the US suggest that current tests for diagnosing ovarian cancer are not good enough and we need to develop better ways of detecting the disease much earlier.

The study is published on 28 July in the open access journal Public Library of Science and is the work of researchers from Stanford University School of Medicine and the nonprofit Canary Foundation, an organization dedicated to the early detection of many types of cancer.

The idea of ovarian cancer scares women and their doctors because it is so hard to detect in the early stages.

The National Cancer Institute (NCI) suggests that estimates show that 21,550 women will be diagnosed with ovarian cancer and 14,600 women will die of the disease in 2009. Worldwide, around 140,000 women die of ovarian cancer every year, wrote the authors.

And it is no comfort that recent studies suggest current tests produce many false positives and dont make any difference to the rates of death.

The symptoms of ovarian cancer are vague and often dont manifest until the tumor is already several centimeters in diameter, by which time it is probably already spreading to nearby tissue and organs.

That is why the overall five year survival rate is only 46 per cent (it is lower for more advanced stages), but according to the NCI, if diagnosis is made early, before the tumor has spread, the five year survival rate is nearer 93 per cent.

The authors of the PLoS paper said that to be able to make a significant reduction in the death rate of ovarian cancer, tests would have to be able to find tumors smaller than 1 cm in diameter, which is about 200 times smaller than the size currently used to assess new tests.

While this seems like an almost impossible goal, there is some good news it takes around four years before cancers of this size become life threatening, so the window of opportunity for early lifesaving diagnosis is quite large.

Stanford biochemistry professor Patrick O Brown, who coauthored the paper with colleague Dr Chana Palmer, of the Canary Foundation, told the press that

“We are miles away from detecting the most deadly ovarian tumors at this early stage.”

“But now we have a chance of actually designing an effective test that will allow us to treat them before they become deadly,” he added.

Current tests for ovarian cancer look for abnormally high levels of protein in normal blood, but Brown suggested that blood tests would be more effective if they could rely on new markers that are never produced by small cells.

Another approach could be to use new molecular imaging techniques or use fluid samples from the uterus or vagina where tumors are likely to be more concentrated, he said, explaining that

“Reliable early detection would save so many more lives than many new blockbuster anticancer drugs.”

“If we can do this, which is no small challenge, the potential to go from a less than 20 percent chance of surviving five years to a relatively minor surgery that would have a very high cure rate is huge,” he added.

The authors explained that part of the difficulty of creating a new reliable test is that there is more than one type of ovarian cancer.

The deadliest form, serous ovarian cancer, accounts for about half of all cases but is responsible for at least 80 per cent of the deaths because unlike other forms of the disease, serous ovarian cancer starts spreading to other sites when tumors are quite small and in most cases before diagnosis.

A flaw with the design of current tests is that they are based on the assumption, derived from observations of how other cancers progress, that early stage tumors are just smaller versions of late stage tumors.

However, Brown and Palmer suggest that in ovarian cancer the early stage tumors are intrinsically different from the ones that occur later and thus cant be found using tests designed according to principles used in other cancer tests.

As Brown explained

“It dawned on me at some point that we were being somewhat glib about what it was we were trying to detect.”

“What we really needed to know is what the moredangerous tumors looked like before we knew they were there,” he added.

Brown and Palmer realized such a source of tumors could be tissue from women with the BRCA1 gene mutation. Some women who know they carry this mutation elect to have their ovaries and fallopian tubes removed to reduce the risk.

Also, Brown and Palmer found when they analysed some previous studies, that although these women appeared healthy when they have the surgeries, in around 8 per cent of cases, closer examination of the tissue shows they actually had early undiagnosed serous ovarian tumors.

They then pooled the results of several studies and estimated the prevalence, location, size and stage of the tumors, and by comparing the results with the incidence of diagnosed serous ovarian tumors in a similar group of women, they estimated that the window of opportunity for early detection and potentially successful treatment to be 4.3 years.

They also suggest that for most of this time the tumors stay at less than 1 cm in diameter, but once they get to 3 cm, more than half of them are at stages III and IV (ie spread beyond the pelvis). Compare this to the 10 cm average diameter of an ovarian cancer tumor at time of diagnosis.

Brown said they found that most serous ovarian tumors that they reviewed had progressed to an advanced stage nearly a year before diagnosis.

He and Palmer estimate that to halve the deaths from serous ovarian cancer, we would need an annual screening test that could detect tumors at around 0.5 cm in diameter, which is far beyond the range of any of the currently available tests.

However, Brown said he was not gloomy about this. He is now trying to find out if there might be ovarian cancer markers in fluid samples taken from the vagina or cervix, which would overcome the problem of marker dilution that occurs with blood samples.

His great hope is that he will find a truly cancerspecific molecular marker, a new protein or piece of DNA that occurs only in ovarian cancer cells.

He thinks it may also be possible to devise ovarian cancer imaging techniques similar to the mammogram for breast cancer.

“The Preclinical Natural History of Serous Ovarian Cancer Defining the Target for Early Detection.”
Patrick O Brown and Chana Palmer.
PLoS Medicine, PLoS Med 6(7) e1000114, Open Access, July 2009.
doi10.1371/journal.pmed.1000114

Source Stanford University Medical Center.

Written by Catharine Paddock, PhD

Eli Lilly and Company continues to lead the way in advancing lung cancer treatment. On the heels of new FDA and European Commission approvals for ALIMTA((R)) (pemetrexed for injection) as a treatment for nonsquamous nonsmall cell lung cancer (NSCLC) in the maintenance setting, the company will release findings from more than 30 lung cancer studies at the 13th World Conference on Lung Cancer (WCLC) in San Francisco, Calif., from July 31 to Aug. 4, 2009. WCLC is sponsored by the International Association for the Study of Lung Cancer. Data will feature Lillys ALIMTA and GEMZAR((R)) (gemcitabine HCl for injection).

“Our goal is and has always been to improve treatment options for individual patients,” said Richard Gaynor, M.D., Lilly vice president, cancer research and global oncology platform leader. “In lung cancer in particular, histology provides us with one way to tailor treatment with ALIMTA for patients living with nonsquamous NSCLC.”

ALIMTA, launched in 2004, continues to be evaluated in a number of NSCLC treatment settings. At WCLC, the company will share data involving ALIMTAbased regimens in combination with radiation for inoperable stage IIIA/B NSCLC.

Globally, lung cancer impacts more than 3 million people and is one of the most common cancers worldwide, accounting for 1.2 million new cases annually.(i)

Studies of note for ALIMTA include

B2.6 Oral Presentation Aug. 2, 2009, 330 p.m. PDT

Pemetrexed is more effective* in patients with nonsquamous nonsmall cell lung cancer (NSCLC) histology An analysis of three large, randomized, phase III trials (* vs. the respective comparators in these three trials)

D2.6 Oral Presentation Aug. 4, 2009, 130 p.m. PDT

Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) +/ enzastaurin (E) versus docetaxel (D) + Cb as firstline treatment of patients (pts) with stage IIIB/IV nonsmall cell lung cancer (NSCLC)

PD9.1.1 Poster Discussion Session Aug. 3, 2009, 1030 a.m. PDT

Histological analysis in Pemetrexed treated patients with stage IIIB/IV NSCLC Results from an open label randomized phase II study

PD8.1.3 Poster Discussion Session Aug. 3, 2009, 1030 a.m. PDT

Ongoing Phase II Study of Pemetrexed plus Carboplatin or Cisplatin with Concurrent Radiation Therapy Followed by Pemetrexed Consolidation in Patients with FavorablePrognosis Inoperable Stage IIIA/B nonsmall cell Lung Cancer Interim Safety Update

PLLY

ALIMTA((R)) (pemetrexed for injection), Lilly

Important Safety Information for ALIMTA

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous nonsmall cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA for the treatment of patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC), a specific type of NSCLC, to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.

ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not receive it. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow function. It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.

Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal antiinflammatory drugs used to treat pain or swelling). Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.

Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional.

You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.

Important Safety Information for GEMZAR (gemcitabine HCl for injection)

GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the firstline treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or cancer that has spread) nonsmall cell lung cancer for whom surgery is not possible.

GEMZAR may not be appropriate for some patients

If you are allergic to GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby.

If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be right for you. GEMZAR has not been shown to work in children. Tell your doctor if you are taking other medicines, including prescription and nonprescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea, vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an infection.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood test and on your general condition.

This press release contains forwardlooking statements about the potential of ALIMTA for the treatment of nonsmall cell lung cancer and reflects Lillys current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the products will receive additional regulatory approvals. There is also no guarantee that the products will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lillys filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forwardlooking statements.

(i) World Health Organization Global cancer rates could increase by 50% to 15 million by 2020, Fact sheet

At 96week follow up, data from the MERIT ES analysis show that treatmentnaïve HIV patients taking Celsentri/Selzentry (maraviroc), in combination with Combivir® (zidovudine/lamivudine) experienced comparable virologic suppression to undetectable levels and significantly greater increases in CD4 Tcell count through 96weeks, compared to patients taking efavirenz in combination with zidovudine/ lamivudine. The data also show the favorable tolerability of Celsentri/Selzentry, which was associated with fewer discontinuations due to adverse events.1

The 96week results from MERIT ES were presented today at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town, South Africa. MERIT ES is an analysis of the data from the MERIT (Maraviroc versus Efavirenz Regimens as Initial Therapy) study following retesting of screening samples using the enhanced sensitivity Trofile™ assay therefore representing a subset of the MERIT primary analysis population. This enhanced sensitivity test was not available at the time of the MERIT study and is the only version of Trofile currently available.

Results from the MERIT ES population show that, at 96 weeks, a similar number of patients taking Celsentri/Selzentry achieved undetectable viral load compared to those taking efavirenz (50 copies/mL. A patient classified as a primary efficacy nonresponder required one viral load measurement of >50 copies/mL.

About Celsentri/Selzentry

Celsentri/Selzentry is an oral medicine that blocks viral entry to human cells. Rather than fighting HIV inside white blood cells, Celsentri/Selzentry prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 coreceptor.

Celsentri/Selzentry has been approved for use in several markets around the world including the United States, Canada and European Union in combination with other antiretroviral medicinal products, for the treatment of experienced adult patients with only CCR5tropic HIV1 detectable.

In South Africa, maraviroc is not available commercially and is currently under review by the Medicine Control Council. Maraviroc is marketed under the trade name Selzentry® in the United States and Celsentri® in all other countries in which it is approved.

Pfizer Inc Working together for a healthier world™

Founded in 1849, Pfizer is the worlds premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

DISCLOSURE NOTICE The information contained in this release is as of July 21, 2009. Pfizer assumes no obligation to update any forwardlooking statements contained in this release as the result of new information or future events or developments.

This release contains forwardlooking information that involves substantial risks and uncertainties about a potential additional indication for Celsentri/Selzentry, including its potential benefits, that is under review by the United States Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA). Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by the FDA, the EMEA and other regulatory authorities regarding whether and when to approve supplemental drug applications that have been or may be filed for such additional indication as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such additional indication; and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizers Annual Report on Form 10K for the fiscal year ended December 31, 2008 and in its reports on Form 10Q and Form 8K.

1 Pfizer Abstract The MERIT study of maraviroc in antiretroviralnaïve patients with R5 HIV1 96week results.

2 Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;1063143 3421.

Need another reason to commit to a healthy diet and exercise? Think migraines are just headaches? Migraine and obesity sufferers feel more emotional pain than those dealing with lifethreatening conditions like congestive heart failure, prostate cancer, osteoporosis and high blood pressure. In fact, they tend to feel more pessimistic than those diagnosed with depression.

In a study about healthcare influencers, AdSAM®, a nonverbal process of measuring emotional response, and TNS Healthcare found that people who suffer from some severe diseases accept and handle them better than other types of sufferers.

“People suffering from prostate cancer, seem to cope better than those suffering from migraine headaches,” said Jon Morris, Ph.D., the president of AdSAM® and a communications professor at the University of Florida.

Results showed that migraine, obesity and erectile dysfunction sufferers essentially feel afraid, disgusted and saddened by their situation. Understanding the emotional impact of these and other conditions is critical to the physicians approach to condition management but also to those loved ones helping a patient through the condition.

Because of their embarrassed stateofmind, those who suffer from obesity and erectile dysfunction often feel more comfortable talking with influencers nonhealthcare professionals such as relatives, friends, coworkers, etc., rather than physicians.

Obesity sufferers in particular feel most relaxed when discussing healthcare decisions with influencers. For men or women, the research shows that influencers are most often the women in sufferers lives, such as their spouses, mothers, sisters or female friends.

“Understanding the emotions surrounding the condition and the patients emotions towards the physician, as well as other influencers, has a major impact on how to communicate effectively with a patient,” Morris said.

TNS Healthcare also conducted research into communications in healthcare. The results indicated that an integrated communications program targeted to patients, physicians and influencers is needed to reach and impact people most effectively, especially in todays digital age.

There are countless opportunities to seek healthcare information through the Internet and other channels. Discovering peoples true emotions can help physicians identify individual needs and informationseeking preferences.

Source

Despite increasing danger posed by “al Qaedalinked militants,” U.N. Emergency Relief Coordinator John Holmes said Tuesday U.N. aid workers “were not backing away” from the country, Reuters reports. “Intense fighting is making it increasingly difficult to deliver aid in the Horn of Africa country, where U.N. agencies are trying to combat cholera outbreaks and maintain food supplies to 3.5 million hungry people,” the news service writes (Nebehay, 7/21).

Holmes statements came one day after “Somalias hardline Shebab militia raided the offices of the U.N. Development Program, the U.N. Department of Safety and Security and the U.N. Political Office for Somalia in Baidoa and Wajid,” forcing the agency to temporarily suspend its work in Baidoa, the AFP/Google.com reports. U.N. SecretaryGeneral Ban Kimoon on Tuesday condemned the actions of the Somali militiamen while reaffirming the agencys commitment to the people of Somalia (7/21).

In addition to 400,000 people already crowded into shelters, “[a]n estimated 223,000 residents have now left Mogadishu since early May, when the AlShabaab and HisbulIslam militant groups launched attacks against Government forces in the capital,” U.N. News Sevice/allAfrica.com reports. “There is a lack of adequate shelter, sanitation facilities and clean drinking water. The situation has grown worse following recent torrential rains. The lack of sufficient latrines poses a major health risk,” U.N. High Commissioner for Refugees spokesman Ron Redmond said.

The WHO is “especially concerned about deadly outbreaks of acute watery diarrhoea, which is on the rise again around Mogadishu after two years of decline,” the news service writes. The regions health centers are also overwhelmed, with “[t]wo of Mogadishus four functioning hospitals … admitting only warwounded patients and trauma patients for emergency surgery” and the closure of several health facilities in the Bakool region due to “insecurity and hostility towards aid workers” (7/21).

Last week, the U.N. Office for the Coordination of Humanitarian Affairs appealed for donor help to deal with Somalias growing health crisis (Kaiser Daily Global Health Policy Report, 7/17).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Commenting on the final biennial report from the Mental Health Act Commission released by the Care Quality Commission, Mental Health Network director Steve Shrubb said

“While the Commission rightly acknowledges that often very vulnerable people are looked after effectively and with care, we know there is more to do to make this the norm across all services.

“The commission is also right to highlight the high number of community treatment orders and we agree that we need a more detailed understanding of how they are being used.

“The Mental Health Network has been calling for some time for the mandatory training and accreditation scheme for all staff who may be engaged in restraint practices to be set up as soon as possible.

“We are also working with the department of health among others to develop an acute pathway declaration which will set out the kind of support people can expect along with a national plan to implement it.”

Notes

The Mental Health Network represents the majority of mental health trusts. It was launched in spring 2007 to provide a distinct voice for providers of NHS mental health services.

Source