US authorities are investigating concerns that antiobesity drug Orlistat may cause liver damage.

Orlistat went on sale under the brand name Alli without the need for a prescription in the UK in April.

The US Food and Drug Administration (FDA) has received more than 30 reports linking the drug to serious liver injury.

The pill, which works by blocking the absorption of fat in the body, is considered an option for people with diabetes who have a Body Mass Index (BMI) of 28 or more. It is also available on prescription as Xenical. Clinical trials suggest adding Orlistat to a reducedcalorie, lowerfat diet, can help people lose 50 per cent more weight than dieting alone.

Conducting a new review

The FDA said it was now conducting a review of the safety of the drug, but stressed no definite association with liver damage had been established at this stage. The European Medicines Agency said there was no plan to change the product information at present but the situation was under review. The manufacturer GlaxoSmithKline said there was no evidence the drug caused liver damage.

Antiobesity drugs a last resort

Zoe Harrison, Care Advisor at Diabetes UK, said “If people taking Orlistat are concerned about their health, Diabetes UK would advise them to contact their healthcare team, particularly if they experience possible symptoms of liver injury such as jaundice (yellowing of skin or eyes), loss of appetite or nausea.

Researchers at the University of Wisconsin School of Medicine and Public Health examined records of rheumatoid arthritis (RA) patients from the national Veterans Health Administration (VHA) system to determine the prevalence of rheumatoid vasculitis (RV) in this population. The study found a downward trend in the number of RA patients who go on to develop RV, with a significant drop of 53% among inpatients and 31% among outpatients between 2000 and 2001. Full details of the study are published in the September issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.

Rheumatoid Vasculitis is a complication of severe RA, an autoimmune disease that causes painful inflammation of the joints. Approximately 2%5% of RA patients develop RV, an extraarticular (occurring outside the joint) manifestation of rheumatoid arthritis, affecting small and mediumsize arteries in the body. RV can involve many body organs including the skin, eyes, heart, lungs, nerves to the hands and feet, as well as blood vessels in the fingers and toes.

In this crosssectional study, Christie Bartels, M.D., and colleagues from the University of Wisconsin School of Medicine analyzed data on patients admitted to VHA hospitals over a 22year period (19852006) or seen in outpatient settings over a 10year period (19972006). More than 37,000 patient records where a diagnosis of RA was noted qualified for the study and 92% of those being men with a mean age of 64.9 years. To determine a RV diagnosis, researchers included those patients who had one of the following arteritis, mononeuritis multiplex (damage to multiple individual nerve fibers), peripheral neuropathy due to connective tissue disease, gangrene, or chronic ulcers.

A past study of data from California hospitals also showed hospitalizations for RV declined between 1980 and 2001. But analysis of only inpatient data raises questions of whether RV cases escaped detection due to changing outpatient management of the disease. “Our study is the first to examine a national U.S. population for RV prevalence among both inpatients and outpatients,” stated Dr. Bartels. “We found the frequency of RV fell from 41 to 28 cases per 1,000 RA outpatients and from 32 to only 15 cases per 1000 RA inpatients.”

Researchers believe the decline in RV reported in the current study may be attributed to a decrease in the number of RV incidences, a disease cure in some patients, patients discontinuing VHA services or dying, or error. Treatment for rheumatoid arthritis improved throughout the 1990s and researchers speculate that the use of biologic agents and more aggressive combinations of antirheumatic drugs targeting severe RA may have diminished extraarticular disease, such as RV.

Additionally the authors noted that the VHA made systemwide efforts to decrease tobacco use among patients that may have impacted the rates of rheumatoid vasculitis prevalence. “Future studies should examine trends in smoking and pharmacotherapy in relation to RV, and ongoing monitoring is merited,” concluded the authors.

This study included a greater number of men who were older than average RA patients and whose use of tobacco was likely higher than most RA cohorts. These demographics may limit the ability to apply the results to the general RA population. “Previous reports have described increased rates of extraarticular manifestations among men, smokers, and persons who were older at the time of RA onset, so perhaps the characteristics of our study sample facilitated detection of changes among the most atrisk population,” Dr. Bartels surmised. “As RA treatment evolves, it will be important to continue following trends in rheumatoid vasculitis prevalence using samples with a sex ratio that more closely reflects the general population,” she added.

Article
“Decline in Rheumatoid Vasculitis Prevalence Among US Veterans,” Christie Bartels, Carolyn Bell, Ann Rosenthal, Kazuhiko Shinki, and Alan Bridges. Arthritis & Rheumatism; Published Online August 27, 2009 (DOI 10.1002/art.24775); Print Issue September 2009.

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Dawn Peters

Data in a recent study published in Neurology, the medical journal of the American Academy of Neurology links elevated diastolic blood pressure to the cognitive impairment of people over 45

The study of nearly 20,000 people aged 45 (average age 65) found that people with high diastolic blood pressure, the bottom number of a blood pressure reading, were more likely to have cognitive impairment or problems with their memory than people with normal readings.

Previous research has demonstrated that people with high blood pressure have an increased risk of developing dementia later in life.

High blood pressure affects one in three adults in the UK with a quarter of people not aware that they have it.

This large study adds weight to the growing body of evidence that high blood pressure can be linked to cognitive impairment. Now further study is needed to establish why these two factors could be linked.

Alzheimers Society recommends that you can reduce your blood pressure by exercising regularly, eating healthily and not smoking. High blood pressure can often also be controlled by medication so if youre not sure what your blood pressure is or havent had it checked recently you should visit your GP to have it measured.

Dr Susanne Sorensen
Head of Research
Alzheimers Society

Reference Association of higher diastolic blood pressure levels with cognitive impairment G Tsivgoulis, MD, A.V Alexandrov, MD et al (Neurology, 25 August 2009)

Source

The National Association of Chain Drug Store (NACDS) implemented its Rapid Response Program, following a recent editorial on drug importation.NACDS President and CEO Steven C. Anderson, IOM, CAE penned a response to the editor to the Delaware County Daily Times (Delaware County, Pa.) after an editorial ran on August 19 citing NACDS and asserting that chain drug stores should not be concerned about where prescription medications come from so long as they are less expensive for consumers to purchase. Here is a link to the editorial

The NACDS Rapid Response Program was created to address inaccurate or inappropriate portrayals of pharmacy, or call attention to an issue that impacts the pharmacy industry. Below is the text of Andersons response

Dear Editor

The August 19 editorial, “Yelling and partisanship wont solve crisis”, inaccurately asserts that chain drug stores should not worry about the origin of prescription drugs so long as they are inexpensive for consumers.

Pharmacies are convenient, accessible healthcare providers. Your neighborhood pharmacist counsels patients in obtaining the most cost effective and appropriate medications and therapies to improve their health outcomes.

However, we do not believe that consumer safety should be compromised to achieve lower costs. Safety cannot be ensured in any system that allows for the personal importation of prescription medications. In addition, individuals who obtain prescription medications through a personal importation scheme do not have a licensed pharmacist available to consult with them about using the medications safely and effectively.We are committed to advancing policies that expand consumer access to safe, affordable, and effective prescription drugs, which is a key component of a reformed system.

Steven C. Anderson, IOM, CAE
President and CEO

Tikcro Technologies (PK TIKRF) announced that the United States (”US”) Department of Health and Human Services (”HHS”) has granted orphan drug status to BioCancells BC819 drug, currently in Phase I/IIa clinical trials, for its use in treating ovarian cancer.

Tikcro holds 36% of Biocancell (after conversion of notes and exercise of warrants), and 27% on a fully diluted basis.

The US Food and Drug Administration (”FDA”) defines an orphan drug as one that treats a disease affecting less than 200,000 people each year. The main benefit received under orphan drug status is the right to market the drug exclusively for 7 years from the date it is approved. Additional benefits include certain tax benefits and waived FDA fees.

The first patient in a Phase I/IIa clinical trial for advanced ovarian cancer using BC819 began treatment in the second quarter of 2009. The trial addresses patients suffering from advanced ovarian cancer characterized by ascites, peritoneal cavity fluid containing cancerous cells that did not previously respond to standard treatment for the disease. The trial is expected to include a total of 12 patients, each receiving nine weekly treatments.

The University of Pennsylvania Medical Center in the US and three centers in Israel the Wolfson Medical Center in Holon, the Meir Medical Center in Kfar Saba and the Hadassah Medical Center in Jerusalem, are recruiting patients for the trial. The Massey Cancer Center of Virginia Commonwealth University in the US is expected to begin recruitment pending certain local regulatory approvals.

This Phase I/IIa trial follows a compassionate use trial conducted in Israel with a patient suffering from ovarian cancer characterized by intraperitoneal distribution of metastases and ascites, who failed conventional chemotherapy treatment. The results of the compassionate trial showed that the drug caused no serious adverse events (”SAEs”) at any dosage. Additionally, the patients blood showed a 50% decrease of the ovarian cancer marker protein CA125, and a significant decrease in the number of cancerous cells in the ascites was measured. Clinical improvement was reported in the patients condition.

Source

The U.S. Food and Drug Administration announced that it is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the overthecounter medication Alli.

Between 1999 and 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDAs Center for Drug Evaluation and Research Drug Safety Oversight Board.

“The issues here are complex, but FDA has benefited from the input of the Board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” said Steven Osborne, M.D., executive director of the Board.

The FDAs analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. Consumers taking Xenical should continue to take it as prescribed, and those using overthecounter Alli should continue to use the product as directed.

Full text of the Early Communication about an Ongoing Safety Review can be found here.The Early Communication is a risk communication tool used by the FDA to inform the public about its ongoing safety reviews of drugs. The FDA will release its findings on orlistat as soon as the review is completed.

Consumers who have used orlistat should consult a health care professional if they experience symptoms possibly associated with development of liver injury, particularly weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, lightcolored stools, itching, or loss of appetite.

The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDAs MedWatch Adverse Event Reporting program either online, or by regular mail, fax, or phone.

Online
Regular Mail use postagepaid FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 208529787
Fax 800FDA0178

US health officials are considering whether to promote routine circumcision for all baby boys born in the country as a way to reduce the spread of HIV; a topic that is giving rise to considerable debate in anticipation of the Centers for Disease Control and Preventions official draft recommendations on the subject that are due out at the end of the year.

The New York Times reported online yesterday, in an article that will appear in todays print edition, that experts are also considering whether circumcision should also be offered to adult heterosexual men whose sexual behaviour puts them at higher risk of infection.

The reasons behind the consideration stem from several studies in support of male circumcision as a way to reduce HIV spread.

Trials in Africa, where there are several countries with severe AIDS and HIV epidemics, have shown that male circumcision reduced HIV infection risk by 50 per cent in heterosexual men who were at high risk of infection from women with HIV.

And earlier this year, an Australian study suggested that the inner foreskin has the largest concentration of Langerhans cells, which are the initial cellular targets in the sexual transmission of HIV. The researchers suggested that removing the skin surface which is most susceptible to the virus would reduce the risk of contracting HIV.

However, there is also a strong opinion that large scale male circumcision will not make a big difference in the US where the group at highest risk is men who have sex with men, and there is no evidence that circumcision prevents the spread of HIV among this group.

Another reason that the measure might have less impact in the US is because health officials there suggest that nearly 80 per cent of adult American males are already circumcised, although this is likely to go down in the future because there is less routine circumcision of newborns nowadays, reports the New York Times.

Another argument that is being put against the idea of promoting male circumcision in newborn boys is that it subjects them to a medical procedure of questionable health value without their permission.

However, the CDC HIV/AIDS Divisions chief epidemiologist, Dr Peter Kilmarx said every potential step that could prevent the spread of HIV should be seriously considered. He said there is a significant HIV epidemic in the US and every opportunity to add another “tool in the toolbox” should be examined.

“What weve heard from our consultants is that there would be a benefit for infants from infant circumcision, and that the benefits outweigh the risks,” he told the New York Times.

However, he did acknowledge that the situation in Africa was different to the US and the effect of male circumcision was likely to be less dramatic both because the disease was not so prevalent in the US and because the routes of infections were also different. Another consideration was the difference in health care infrastructures.

Circumcision will be a discussion topic at the CDCs National HIV Prevention Conference which takes place this week in Atlanta and is expected to be attended by thousands of HIV health professionals.

Intact America, a group that is against the idea of routine circumcision for newborns is holding a protest in the city to coincide with the conference.

They will be arguing that the facts show that circumcision only reduces the risk of HIV infection, it does not eliminate it, and circumcised men still have to wear condoms.

Sources New York Times, MNT archives

Written by Catharine Paddock, PhD

“An apple a day…” Not all medical problems require a stateoftheart solution, and it would be nice to think that products from the corner shop could treat a widespread and uncomfortable ailment. Cranberry juice and related products have been touted as a simple solution for urinary tract infections, but Raul Raz, a member of F1000 Medicine, finds little to support this claim.

Urinary tract infections (UTIs) are a common complaint. Between 10% and 20% of women will suffer a UTI at least once, and a third of these will experience it recurrently. Some recent studies support the use of cranberry as a preventative, but Dr Raz, Director of Infectious Diseases at the Technion School of Medicine in Israel, and his associate Faculty Member, Hana Edelstein, advise the medical community that “cranberry should no longer be considered as an effective [preventative] for recurrent UTIs”.

Cranberry contains hundreds of compounds, and it has been difficult to determine which might be responsible for any therapeutic effect, hindering its adoption. Raz and Edelstein point to differences in clinical trial design and the lack of standardization for doses and formulation. There is a range of potential sideeffects including stomach upsets and weight gain. Cranberry can also interact badly with other medicines such as Warfarin, commonly used to treat heart disease.

In any event, up to 55% of patients discontinue cranberry therapy after a short time. It would seem that the public have already voted with their feet.

New research at The University of Texas Health Science Center at Houston suggests that ancient Chinese herbal formulas used primarily for cardiovascular indications including heart disease may produce large amounts of arterywidening nitric oxide. Findings of the preclinical study by scientists in the universitys Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases (IMM) appear in the Sept. 15 print issue of the journal Free Radical Biology & Medicine.

Nitric oxide is crucial to the cardiovascular system because it signals the inner walls of blood vessels to relax, which facilitates the flow of blood through the heart and circulatory system. The messenger molecule also eliminates dangerous clots, lowers high blood pressure and reduces arteryclogging plaque formation.

The results from this study reveal that ancient Chinese herbal formulas “have profound nitric oxide bioactivity primarily through the enhancement of nitric oxide in the inner walls of blood vessels, but also through their ability to convert nitrite and nitrate into nitric oxide,” said Nathan S. Bryan, Ph.D., the studys senior author and an IMM assistant professor.

Herbal formulas are a major component of traditional Chinese medicines (TCMs), which also include acupuncture and massage. “TCMs have provided leads to safe medications in cancer, cardiovascular disease and diabetes,” said C. Thomas Caskey, M.D., IMM director and CEO. “The opportunity for Dr. Bryans work is outstanding given that cardiac disease is the No. 1 cause of death in the United States.”

In the study, researchers performed laboratory tests on DanShen, GuaLou and other herbs purchased at a Houston store to assess their ability to produce nitric oxide. Ancient Chinese herbal formulas used primarily for cardiovascular indications are made up of three to 25 herbs. The formulas can be administered as tablets, elixirs, soups and teas.

Most Chinese herbal formulas marketed in the United States are not considered drugs by the U.S. Food and Drug Administration, said YongJian Geng, M.D., Ph.D., study coauthor and cardiology professor at The University of Texas Medical School at Houston. They are considered dietary supplements and are not regulated as strictly as drugs.

Scientists also tested the capacity of the storebought TCMs to widen blood vessels in an animal model. “Each of the TCMs tested in the assays relaxed vessels to various degrees,” the authors stated.

“Further studies should be considered in humans, particularly those with cardiac indications,” Geng said. “Hopefully, we will have more data to report in the near future.”

While fully integrated into the healthcare systems in some parts of Asia, ancient Chinese herbal formulas are often considered alternative medicines in Western nations. Part of the reason, according to Bryan, may be that until recently little was known about how they work.

“The next step is to identify the active components of the TCMs that are responsible for producing the NO. We are currently trying to isolate and identify the active component or components,” Bryan said.

Yaoping Tang, M.D., an IMM postdoctoral fellow, was the lead author of the study titled “Nitric oxide bioactivity of traditional Chinese medicines used for cardiovascular indications.” Also collaborating on the study was Harsha Garg, an IMM senior research assistant.

Bryan is the editor of a new book titled “Food, Nutrition and the Nitric Oxide Pathway Biochemistry and Bioactivity” published by DesTech Publishing and works in the IMM Center for Cell Signaling directed by Ferid Murad, M.D., Ph.D., who won the 1998 Nobel Prize in Physiology and Medicine for his work with nitric oxide as a signaling molecule in the cardiovascular system. Bryan and Geng are on the faculty of The University of Texas Graduate School of Biomedical Sciences at Houston.

Source
Robert Cahill

Provectus Pharmaceuticals, Inc. (OTCBBPVCT), a developmentstage oncology and dermatology biopharmaceutical company, has added Mount Sinai School of Medicine as its second and final site for its expanded Phase 2 clinical trial of the Companys lead dermatology agent PH10 for psoriasis. Jason Emer, M.D. will serve as principal investigator of the trial; he is also the lead investigator for the Phase 2 clinical trial of PH10 for atopic dermatitis, for which patient enrollment was completed in June.

Craig Dees, Ph.D., CEO of Provectus said, “Dr. Emers work with PH10 for atopic dermatitis, his involvement in the ongoing research of the product as a dermatological therapy, and Mount Sinai School of Medicines outstanding reputation in dermatological research make this center an outstanding choice for the second and final site of our ongoing Phase 2 trial for psoriasis.”

Enrollment in the Phase 2 trial for psoriasis commenced in July 2009, and has an expected enrollment of 30 subjects. It is a nonrandomized, open label, single group assignment trial that is designed to measure safety and efficacy of PH10. PH10 is an aqueous hydrogel formulation of rose bengal disodium for topical administration to the skin, and is being studied for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. The estimated primary completion date for final data collection is February 2010, with the study estimated to be completed by April 2010. Patients interested in participating in the trial may find further information at the NIH clinical trials registry, clinicaltrials.gov or at pvct.com.

Craig Dees, Ph.D., CEO of Provectus added, “The addition of this second site at Mount Sinai School of Medicine supports our developmental efforts for PH10 which include either a licensing agreement or codevelopment partnership for our dermatological treatments. We are continuing to explore these possibilities with major parties in the dermatology sector as this trial proceeds towards completion.”

According to the National Institutes of Health, as many as 7.5 million Americans, approximately 2.2 percent of the U.S. population, have psoriasis. The National Psoriasis Foundation reports that approximately 125 million people worldwide, 2 to 3 percent of the total population have psoriasis. It also reports that total direct and indirect health care costs of psoriasis for patients are approximately $11.25 billion annually.

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