The risk of a heart attack or stroke is cut by a fifth in those who have no sign of heart disease, shows research by scientists at Oxford University.

The changes involve Propecia and Proscar, both of which contain the active ingredient finasteride, after patients reported additional adverse effects that were not apparent at the time of the drugs’ approval, the US Food and Drug Administration said Friday.

The new Propecia label will include “libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug,” the FDA said. Propecia is a drug to treat male baldness.

Proscar, which treats symptoms of enlarged prostate, will now have a label that adds “decreased libido that continued after discontinuation of the drug.”

In addition, both labels are being revised to “include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation,” the FDA said.

FDA spokeswoman Stephanie Yao said the drugs were previously known to cause adverse sexual events in a small number of patients, and that information was included on labels at the time of approval.

The latest labeling change “expands the list of sexual adverse events reported to the FDA postmarketing,” she told AFP, adding that “no new clinical studies were reviewed to evaluate these adverse events.”

Proscar was approved for the US market in 1992 and Propecia in 1997. In 2011, both drugs’ labels were “revised to include erectile dysfunction that continued after drug discontinuation,” the FDA said.

Last year, labels for Proscar and Propecia were also changed to advise of the possibility of an increased risk of high-grade prostate cancer.

The agency noted that even though “clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs.”

Since these side effects may be important to some patients, doctors were urged to discuss them with patients when deciding on treatment options.

In the case of Propecia, clinical trials showed 3.8 percent of men had reported one or more adverse sexual experiences, compared to 2.1 percent who were taking a placebo.

“Propecia and Proscar are generally well tolerated and effective for their respective intended uses in accordance with their approved product labeling,” Merck said in a statement.

The company added that “a causal relationship between the use of Propecia or Proscar and continued sexual dysfunction after discontinuation of treatment has not been established,” and expressed support for ongoing monitoring of adverse event reports. – AFP

Published in the journal Circulation, Harvard researchers followed 42,880 men over 22 years, measuring the different lipids and proteins in the participants’ bloodstream.

After controlling for risk factors like smoking, physical inactivity, alcohol consumption and family medical history, scientists found that those who consumed sugary beverages on a daily basis had higher levels of triglycerides — or bad fat — and lower levels of good cholesterol or HDL levels compared to men who refrained from sugary drinks.

Both biomarkers are known to be associated with a higher risk of heart disease.

For full story, click here.

These medications were also associated at higher doses with a 35-per cent increased risk of cancer as compared with non-users, but the reason for this is unclear.

Doctors led by Daniel Kripke of the Scripps Clinic Viterbi Family Sleep Center in La Jolla, California, looked at the medical records of more than 10,500 adults living in Pennsylvania who were taking prescribed sleeping aids.

These were compared against more than 23,600 counterparts, matched for age, health and background, who did not take these drugs.

The study ranged over two and a half years, and looked at widely-prescribed sleeping pills, including benzodiazepines, non-benzodiazepines, barbiturates and sedatives.

The overall number of deaths that occurred during this period was small in both groups, being less than a thousand in total.

But there was a striking difference in mortality, the researchers found.

Those who took between 18 and 132 doses of the pills per year were 4.6 times likelier to die than the “control” group.

Even those who took less than 18 annual doses were more than 3.5 times likelier to die.

“Rough order-of-magnitude estimates… suggest that in 2010, hypnotics (sleeping pills) may have been associated with 320,000 to 507,000 excess deaths in the USA alone,” says the study.

Details of how individuals died were not disclosed, and the authors stress that they have found a statistical link but not a cause.

But they sound the alarm, given the vast number of people who take these drugs.

“We estimate that approximately six to 10 per cent of US adults used these drugs in 2010 and the percentages may be higher in parts of Europe,” they write.

The average age of the people in the study was 54. The researchers say they took into account factors that could skew the comparison between the two groups, such as whether an individual smoked or had a pre-existing health condition.

However, they were unable to take depression, anxiety and other emotional factors into account, as these diagnoses are kept secret under Pennsylvania law.

Previous research into sleeping pills has found a link with car accidents and serious falls, “night-eating syndromes” of bingeing on food, regurgitation in the oesophagus and peptic ulcer disease. — AFPrelaxnews.com

People who sleep five hours or less a night may be at higher risk of developing high blood pressure or worsening already high blood pressure. There’s also an increased risk of high blood pressure for people who sleep between five and six hours a night, although that risk is not as high as it is for people who sleep five hours or less a night.

It’s thought that sleep helps your blood regulate stress hormones and helps your nervous system remain healthy. Over time, a lack of sleep could hurt your body’s ability to regulate stress hormones, leading to high blood pressure.

Sleeping seven to eight hours a night may play a role in the treatment and prevention of high blood pressure. Talk to your doctor for tips on getting better sleep, especially if you have high blood pressure.

The results, published in the Feb. 16 online edition of Science Translational Medicine, represent the first successful test of such a device and could help usher in a new era of telemedicine — delivering health care over a distance, Langer says.

“You could literally have a pharmacy on a chip,” says Langer, the David H. Koch Institute Professor at MIT. “You can do remote control delivery, you can do pulsatile drug delivery, and you can deliver multiple drugs.”

For the full report, click here.

The approach was found to increase drug efficacy by 200-fold in in vitro studies based on the ability of these nanomaterials to both protect the drug from degradation and concentrate it at key target sites, such as regions of the pancreas that contain the insulin-producing cells. The dramatic increase in efficacy also means that much smaller amounts of drugs would be needed for treatment, opening the possibility of significantly reduced toxic side effects, as well as lower treatment costs.

The research was led by Wyss Institute Founding Director Donald Ingber M.D., Ph.D. and Kaustabh Ghosh, Ph.D., a former postdoctoral fellow at Children’s Hospital Boston. Their findings appear in the current issue of Nano Letters. Ingber is also the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Children’s Hospital Boston, and Professor of Bioengineering at Harvard’s School of Engineering and Applied Sciences. Ghosh is now an Assistant Professor of Bioengineering at the University of California, Riverside. Wyss Institute Postdoctoral Fellows, Umai Kanapathipillai and Netanel Korin, also contributed to the work, as did Jason McCarthy, Assistant Professor in Radiology at Harvard Medical School and an Assistant in Chemistry at Massachusetts General Hospital.

Type I diabetes, which often strikes children and young adults, is a debilitating disease in which the body’s immune system progressively destroys the cells in the pancreas that produce insulin. According to the Juvenile Diabetes Research Foundation, as many as 3 million Americans have the disease and some 30,000 new cases are diagnosed every year. The risk of developing Type I diabetes, which can lead to serious health complications such as kidney failure and blindness, can be predicted with 90 percent accuracy. But therapeutic intervention for people identified as high risk has been limited because many systemic treatments are barred from clinical use due to the severe side effects they produce when used at the high doses required to achieve a therapeutic response.

“The consequences of Type I diabetes are felt in both the people who live with the disease and in the terrible strain that treatment costs put on the economy,” said Ingber. “In keeping with our vision at the Wyss Institute, we hope that the programmable nanotherapy we have developed here will have a major positive impact on people’s lives in the future.”

Using nanoparticles that can be programmed to deliver drug or stem cell therapies to specific disease sites is an excellent alternative to systemic treatments because improved responses can be obtained with significantly lower therapeutic doses and hence, fewer side effects. To date, such nanotherapeutics have been developed primarily to treat cancer, since they can home in on the tumor via its leaky blood vessels. The challenge has been to develop ways to selectively deliver drugs to treat other diseases in which the tissues of interest are not as easily targeted. The research team addressed this problem by using a unique homing peptide molecule to create “smart” nanoparticles that can seek out and bind to the capillary blood vessels in the islets of the pancreas that feed the insulin-producing cells most at risk during disease onset.

The research was supported by the Wyss Institute and a SysCODE (Systems-Based Consortium for Organ Design and Engineering) grant from the National Institutes of Health that supports a group of seven clinical and academic institutions working to develop new ways to induce regeneration of organs, including the pancreas.

I HAVE chronic lymphocytic leukemia. Three months ago, I underwent an allogeneic stem-cell transplant, in which my wise, 52-year-old white blood cells were replaced by bewildered, low-functioning cells from an anonymous European donor. For the next seven months or so, until those cells mature, I have a newborn’simmunity; I am prey to illnesses like chickenpox, the measles and the flu.

These diseases are rarely fatal, unless you’re a newborn or someone with a suppressed immune system like me. My newborn buddies and I do have some protection, however: the rest of you.

Young babies, the immuno-compromised and people who get chemotherapy are not able to process most vaccinations. Live vaccines in particular, like those for measles and chickenpox, can make us sick. But if 75 percent to 95 percent of the population around us is vaccinated for a particular disease, the rest are protected through what is called herd immunity. In other words, your measles vaccine protects me against the measles.

It’s the reasoning of Clarence, the angel from “It’s a Wonderful Life”: If you are vaccinated, you won’t pass a disease on to someone else, who won’t pass it on to six more people, and on and on. To quote Clarence, “Strange, isn’t it? Each man’s life touches so many other lives.”

Unfortunately, vaccination rates for many diseases in Europe and in areas of the United States are falling. This is partly due to Andrew Wakefield, a British doctor who published a paper, now discredited, in 1998 in The Lancet tying childhood vaccines to autism. Celebrities like Jim Carrey have also taken a strong antivaccine view. As a result of these unwarranted fears, childhood diseases are returning. The rate of whooping cough cases has spiked over the past 20 years. In 1990, the incidence was 2 per 100,000 people; in 2000 it was 3; by last year, it had risen to nearly 10.

Measles cases are also increasing. For each year between 2001 and 2008, the median number of cases in the United States was 56. In the first six months of this year alone, there were more than 150 reported cases — the most since 1996. A vast majority of those who were sickened had not been vaccinated or had uncertain vaccination histories. Before the vaccine was introduced in 1963, 400 to 500 Americans died of measles every year.

During last year’s flu season there were 55,403 reported cases of influenza A and B; 116 children died of the disease. And now flu season is back.

The truth is, we should not get vaccinated for ourselves alone; we should do it for one another. Having cancer has taught me the value of living in a community. We assist the infirm, pay our taxes and donate to charity, and getting vaccinated — for the flu, for adult whooping cough, for pneumonia — is just another important societal responsibility. After all, we’re in the same herd.

The stem cells, taken from human embryos and grown in the lab, are of unprecedented quality and could be offered to researchers before the end of next year for eventual use in clinical trials.

Previous embryonic stem cell (ESC) trials in humans have used lower-quality “research grade” cells, which are manipulated and reclassified into “clinical grade”.

But the new ESCs, described as the “Holy Grail for regenerative medicine”, are of clinical quality from the moment they are donated by patients and do not require a costly and risky conversion.

They are also untainted by animal-derived products which have been used by other researchers to stimulate growth.

Two lines of stem cells, which can be converted into virtually any type of tissue in the body, have been donated to the UK Stem Cell Bank (UKSCB) by researchers from King’s College London.

Prof Peter Braude, a leading member of the team, said: “The key here is that these are clinical grade lines, they have been set up from the beginning as lines that do not contain animal products and have not got animal products coming into contact with them.”

While ESCs of similar quality could potentially have been cultured in secret by private researchers such as drug companies, these are the first of their kind to be developed for public health benefit.

A line of cells of a similar quality is being developed by Manchester University researchers and is expected to be donated to the stem cell bank next month.

At the UKSCB the cell lines will undergo rigorous testing to ensure they are safe and of a sufficient calibre for use in human trials, but it is hoped they will be a “seedstock” for future experiments.

Prof Braude said the achievement, recorded in the Cytotherapy journal, marked ten years of painstaking research.

He said: “Cells that are ready for clinical use have really been the Holy Grail of everybody in terms of regenerative medicine.

“There is still a long way to go … these are not ready for use now. They get handed over to the stem cell bank and they do exhaustive testing and a lot of lines are going to fail.”

The cells could be handed over to university scientists or private companies by the end of next year, though there would likely be a significant period of preparation by researchers before clinical trials actually began.

Dr Glyn Stacey, director of the UKSCB, said: “They will be released – I wouldn’t like to put a date on it, but some time next year.

“The moment we release them they are ready for use in a clinical trial.”

It is widely believed that ESCs could one day be used to generate healthy tissue to replace damaged cells throughout the body, and potentially form the basis of new treatments for conditions like heart disease and Parkinson’s.

ESCs are taken from frozen embryos the size of a pinhead, which are donated to researchers by IVF patients who have no further use for them and would otherwise have been discarded.

Source: http://www.telegraph.co.uk/science/science-news/8938523/Gold-standard-stem-cells-created-by-British-scientists.html

Few politicians will ever admit they are wrong, so I salute health ministers who have finally capitulated to medical opinion and last month announced a U-turn on the cervical cancer vaccine that is given to 12- and 13-year-old girls.