Reviewing the records of 577 breast cancer patients, Fox Chase Cancer Center researchers found that women with newly diagnosed breast cancer who receive a breast MRI are more likely to receive a mastectomy after their diagnosis and may face delays in starting treatment. The study demonstrates that, despite the lack of evidence of their benefit, routine use of MRI scans in women newly diagnosed with breast cancer increased significantly between 2004 and 2005, and again in 2006.

The study is online now and will be appearing in the August edition of the Journal of the American College of Surgeons.

“We have yet to see any evidence that MRI improves outcomes when used routinely to evaluate breast cancer, and yet more and more women are getting these scans with almost no discernable pattern,” said Richard J. Bleicher, M.D., F.A.C.S., a specialist in breast cancer surgery at Fox Chase. “For most women, a breast MRI prior to treatment is unnecessary. MRI can be of benefit because it’s more sensitive, but with the high number of false positives and costs associated with the test, more studies are needed to determine whether MRI can improve outcomes in women who have already been diagnosed with breast cancer.”

Bleicher and his colleagues reviewed the records of 577 breast cancer patients seen in a multidisciplinary breast clinic where they were evaluated by a radiologist, pathologist, and a surgical, radiation, and medical oncologist. Of these patients, 130 had MRIs prior to treatment.

“Those who received an MRI had a three-week delay in the start of their treatment,” said Bleicher. “But more strikingly, we’re concerned that the well-documented false-positive rate with MRIs may be leading�”or misleading-women into choosing mastectomies.”

Bleicher said many of the women would have been candidates for a lesser procedure known as a lumpectomy. “There are a few reasons why we may be seeing higher mastectomy rates when MRIs are performed. An MRI scan is very sensitive, leading to a high number of false-positive findings. Rather than having a biopsy to see if those findings are real, women and their doctors may choose mastectomy out of an abundance of caution. Other studies have demonstrated that this often represents over-treatment because many of the mastectomies are later proven by pathology to have been unnecessary.”

The study also revealed that younger women were more likely to have an MRI. “In our analysis, that trend, surprisingly, didn’t correspond with various breast cancer risk factors, such as a family history of breast or ovarian cancer, nor with the characteristics of their disease,” explained Bleicher.

Another research conclusion included the failure of MRI’s to help surgeons decrease positive margins during surgery, another hypothesized benefit of MRI.

“MRI is a valuable tool in some women, and these findings do not negate their value in screening women at high risk, such as those with genetic mutations. Without evidence, though, that routine pre-treatment MRI improves a woman’s outcome, its disadvantages suggest that it should not be a routine part of patient evaluation after diagnosis,” said Bleicher. “Greater efforts to define MRI’s limitations and use are needed.”

This study was supported by a U.S. Public Health Service grant and by an appropriation from the Commonwealth of Pennsylvania. In addition to Bleicher, other authors include Robin M. Ciocca, D.O.; Brian L. Egleston, Ph.D.; Linda Sesa, N.P.; Kathryn Evers, M.D.; and Elin Sigurdson, M.D., Ph.D., of Fox Chase Cancer Center, and Monica Morrow, M.D., of Memorial Sloan-Kettering Cancer Center. The authors report no disclosures.

Mylan Inc. announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Temazepam Capsules USP, 22.5 mg. This strength is in addition to Mylan’s currently marketed 15 mg and 30 mg strengths of the product.

Temazepam Capsules are the generic version of Mallinckrodt’s Restoril®, a sleep aid, which had total U.S. sales of approximately $6 million for the 12 months ending March 31, according to IMS Health. Mylan has begun shipping this product.

Currently, Mylan has 118 ANDAs pending FDA approval representing $82.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, which represent $16.7 billion in annual brand sales, according to IMS Health.

In a review in Science, a University of Rochester Medical Center researcher sorts out the controversy and promise around a dangerous subtype of cancer cells, known as cancer stem cells, which seem capable of resisting many modern treatments.

The article proposes that this subpopulation of malignant cells may one day provide an important avenue for controlling cancer, especially if new treatments that target the cancer stem cell are developed and combined with traditional chemotherapy and/or radiation.

“The fact that these concepts are steadily making their way into the clinic is exciting, and suggests that the recent interest in cancer stem cells may yield beneficial outcomes in potentially unexpected ways,” wrote co-authors Craig T. Jordan, Ph.D., professor of Medicine at URMC and director of the James P. Wilmot Cancer Center Translational Research for Hematologic Malignancies program; and Jeffrey Rosen, Ph.D., the C.C. Bell Professor of Molecular and Cellular Biology and Medicine at Baylor College of Medicine.

Cancer stem cells (CSCs) are a hot topic in the scientific community. First identified in 1994 in relation to acute myeloid leukemia, CSCs have now been identified in several solid tumors in mice as well. Scientists who study CSCs believe they have distinct properties from other cancer cells, and may be the first cells to undergo mutations.

Research from the past 10 years suggests that because CSCs may be the root of cancer, they also might provide a new opportunity for a treatment. Jordan and a group of collaborators, for example, are testing a new drug compound based on the feverfew plant that demonstrates great potential in the laboratory for causing leukemia CSCs to self destruct.

Another new approach, the authors said, is the use of chemical screens to search drug libraries for already approved agents that may target CSCs, or make resistant tumor cells more sensitive to chemotherapy and radiation.

Cancer stem cell biologists hypothesize that any treatment that targets the source of origin rather than simply killing all cells, healthy and malignant, would be an improvement over most conventional therapies.

Some scientists, however, are uncertain if CSCs have unique biological properties or any relevance to treatment, the authors noted. What is more likely to fuel cancer, other studies have found, are unfavorable factors in the neighboring cells surrounding the tumor, such as mutated genes, proteins that encourage cell growth, and a poor immune system, for instance.

The most challenging issue facing CSC biologists is that the number and type of cancer stem cells can vary from patient to patient. In some tumor samples, for example, CSCs are rare while in others they constitute a large portion of the tumor mass, the authors said.

To understand why CSCs are so variable, investigators are trying to determine what genes and pathways are responsible for activating cancers that have a poor prognosis, and whether these cancers also have a higher frequency of CSCs.

“Whether the cancer stem cell model is relevant to all cancers or not,” they wrote, “it is clear that we need new approaches to target tumor cells that are resistant to current therapies and give rise to recurrence and treatment failure.”

An unexpected benefit of so much attention on normal stem cells is that it has stimulated research in areas not previously the focus of cancer therapies, Jordan and Rosen said.

For example, pathways known to be important for normal stem cell self-renewal, such as the Wnt, Notch and Hedgehog(Hh) pathways, are now of increased interest due to their potential role in CSCs. The first clinical trial using an agent to block the Notch pathway in combination with chemotherapy for breast cancer has begun.

The authors conclude by spotlighting the pressing need for preclinical models to test appropriate doses and combinations of CSC therapies before they can move into human clinical trials.

A quarter of us will experience at least one mental health problem in any one year, and yet stigma and prejudice are still widespread.

In recognition of this hidden health crisis, The Royal Society for Public Health has accredited the Mental Health First Aid (MHFA) training programme in England, developed to establish a network of people with the skills and knowledge to take this essential first aid training into the community.

Mental health problems can affect people at any time, in different ways, and many suffer in silence for a long time before eventually seeking help. The MHFA course trains people to recognise the symptoms of mental health problems, shows how to offer initial help to those affected, and provides information about professional support.

MHFA supports the government’s well-being agenda which highlights the importance of early intervention. Trainees on mental health first aid courses work in many different settings, including commercial organisations, teaching, police and prison services.

Fionuala Bonnar, programme director for Mental Health Services and Improvement, London Development Centre, part of Commissioning Support for London, said: “The MHFA course instructors are a vital link in our work to promote awareness of mental health problems. RSPH accreditation for our instructors’ programme shows that our courses are delivered to the RSPH’s very high standards, giving additional confidence to instructors, trainees and the public.”

RSPH chief executive professor Richard Parish comments: “Many people are familiar with first aid for physical health, but there is a much more limited understanding of first aid for mental health. Early recognition of mental health problems can make all the difference to the outcome for individuals and their families, and the mental health first aid course gives trainees the practical knowledge to help identify anyone who may need professional help. Excellent training for these instructors is essential to the success of this much needed work. RSPH accreditation confirms the high quality of the instructor training programme and I congratulate all those involved in achieving this recognition.”

Never before have doctors had so many medical tests at their disposal—tests to screen for disease, to diagnose disease, to classify and measure the severity of a disease that has already been diagnosed, to confirm that a person is free from disease, or to plan the treatment for a disease or condition—and these tests drive a large part of the clinical decisions made about our health. Simple tests performed in a doctor’s office often have immediate results, whereas other tests that require a laboratory may take days or even weeks. But given the crucial role test results play in medical decision-making, the patient is notified soon after the doctor receives and reviews the findings, especially if there is a problem, aren’t they?

In far too many instances—the answer is NO. A recent analysis of 5,434 patient records from 23 primary care practices in the Midwest and on the West Coast revealed that doctors either failed to report abnormal tests or document that the patient had been informed of the results 7.1 percent of the time, or about one out of every 14 tests. However, performance at individual practices varied; some consistently informed patients and some failed to inform patients as much as 26 percent of the time. The tests included mammograms, Pap smears, cholesterol blood work, and screening tests for diabetes and colon cancer.

“It really does happen all too often,” said lead author Dr. Lawrence Casalino, chief of the Division of Outcomes and Effectiveness Research in the Department of Public Health of Weill Cornell Medical College. “Even in the best doctor’s office it is possible—and, actually, not uncommon—for test results one way or another to get overlooked.”

The researchers found no significant difference in failure rates between facilities that relied exclusively on paper records and those that used only electronic filings. However, the practices that used a combination of paper and electronic record-keeping had the highest failure rates. “If you have bad processes in place, electronic medical records are not going to solve your problems,” said study co-author Dr. Daniel Dunham of Northwestern University’s Feinberg School of Medicine.

Furthermore, the researchers found that most facilities did not follow basic protocol for test processing, and most did not have an explicit policy on communicating test results to patients. Many offices simply told patients that if they didn’t hear anything, they could assume their test results were normal. “If you’re a patient, it’s often assumed that no news is good news,” Casalino said. “But the bottom line is that is not always the case, and patients should not passively go along with that.”

Failing to inform patients about abnormal test results can lead to a delay in the treatment of serious conditions, possibly decreasing the patient’s chances of survival, and exposing doctors to costly legal action. “If bad things happen to patients that could have been prevented, that will lead to higher costs and in some cases considerably higher costs,” Casalino said. “Failure to diagnose is one of the most common causes of malpractice suits.”

Casalino said it’s imperative that doctors have explicit rules for informing patients of test results. “If you’ve had a test, whether it be blood test or some kind of X-ray or ultrasound, don’t assume because you haven’t heard from your physician that the result is normal,” Casalino said. “You still need to be told whether your tests were normal or not. And if you don’t get the result you’re waiting for, you really should call the doctor’s office and ask for it.”

The authors concluded that following five relatively simple, common-sense procedures could eliminate most errors: (1) all test results are routed to the responsible doctor; (2) the doctor signs off on all results; (3) the office informs patients of all results, normal and abnormal; (4) the office documents that the patient has been informed; and last by not least, (5) patients are told to call after a certain time interval if they have not been notified.

If someone told you that your stress level could go from 300 to 0 with a boost of magnesium, you probably wouldn’t believe them, but you might buy a hefty bottle of magnesium supplements the next time you were in the vitamin and natural health section. Since magnesium is a part of your cells and bones and is especially vital as the smoothing cells of your arteries, it protects those arteries from blood pressure that is caused by stress. Magnesium also helps the body control its absorption of potassium (the mineral found in bananas) and calcium (the reason your mother always made you drink all of your milk). If magnesium can multi-task by also helping the kidneys, adrenals, brain, heart, and nervous system functioning, why wouldn’t it also reduce your stress?

An Australian chemist and nutritionist, Peter Gillham says that between 90 and 95 percent of the world’s population is living with magnesium levels unhealthy for their body. So, what does an unhealthy magnesium level feel like? Here are just some of the symptoms of a magnesium deficiency: asthma, lowered energy levels, sleeplessness, headaches, muscle aches, tension and soreness, fatigue, anxiety, seizures, nervousness, PMS, weak bones, teeth grinding, insomnia, difficulty breathing, and heart problems.

Magnesium depletion—as it’s called—is caused by many small things such as alcohol, smoking, sweating too much, drug use, hypothyroidism (low production of metabolism), diabetes, sugar, carbohydrates, sodium, or calcium-filled diets, and finally stress.

Stress can cause over- or undereating and trigger depression which can lead to a low metabolism with inactivity. It can also increase bad habits such as smoking and drinking, which tend to lead to bigger health issues such as cancer and heart disease.

Magnesium is as important as your daily vitamin and when used in conjunction with calcium, it just may save your life…or your quality of life. By balancing out the nervous system and relaxing the muscles, magnesium should be a welcome addition to any vitamin regimen. If you prefer magnesium the old-fashioned, non-supplemental way, be sure to eat lots of dark green foods, whole grains (check the label), garlic, lemons, avocados, chamomile, and cantaloupe, to name a few.

In terms of over-the-counter remedies, there are a few popular ones that are becoming well-known in natural health circles. A company called Source Naturals debuted a powder called Magnesium Serene which, when dissolved in hot or warm water, gives you at least the recommended daily magnesium at 800 milligrams per serving and absorbs quickly into your body helping you feel more calm and better refreshed. Another popular item off the magnesium shelf is good for those who do not wish to take the time to dissolve powders or generally dislike the taste. This product, offering 250 milligrams of magnesium, comes from one of the most respected natural health suppliers in the country: Nature’s Sunshine. Although not recommended for those with “severe heart disease,” the supplement provides a once-a-day tablet of calcium, magnesium, and phosphorus, along with various herbs and extracts to keep your body at its best.

With incredible health benefits and the determination of a worker bee, it seems that magnesium has been the wallflower of the natural health world. To do so much for the body and also be a great way to replenish the minerals we rid our bodies of, I am amazed that magnesium the “bodily pollution-eater” has not come to my attention before. As with any new addition to your routine, please consult your physician as certain pharmaceuticals and supplements do not mix well. Even if my stress level is not at 300 and I do not have a burgeoning heart problem, I will be stopping by my natural health aisle soon anyway as a preventative measure.

Lipton lovers, beware! With gallons guzzled throughout the year and a guaranteed summer heat-beater, iced tea is the go-to refreshing soda substitute for many. With over 80 percent of the tea drank in the United States each year being iced tea, its popularity is growing with new tea infusions and more bottles being produced to keep up with demand. However, men need to beware, as new evidence suggests that iced tea can make them at higher risk for kidney stones. Lemonade, anyone?

The demographic being targeted for this new study are men over the age of 40 who hold a higher risk for kidney stones. Kidney stones are little crystals developed in the kidneys that travel through the urinary tract into the bladder causing extreme pain. Side effects of a kidney stone can include nausea and vomiting as well as added kidney pressure depending on the size and length of time it stays within the body blocking the flow of urine. Kidney stones affect about 10 percent of the population and while women aren’t immune, men are four times more at risk of developing them.

A recent news release by Loyola University Chicago Stritch School of Medicine’s urology department delved into the occurrence of Oxalate, a main chemical ingredient in the formation of stones within the kidneys, is also highly concentrated within iced tea. An instructor at Loyola, John Milner said, “For many people, iced tea is potentially one of the worst things they can drink and for people who have a tendency to form kidney stones, it’s definitely one of the worst things you can drink.” Experts contend that water is the best substance to drink to stave off dehydration, but if you’re looking for a little flavor, add a slice of lemons or simply make lemonade to jumpstart your taste buds. Milner continues his observations and explains why lemonade is a healthier alternative to iced tea, “Lemons are very high in citrates, which inhibit the growth of kidney stones,” said Milner, “Lemonade, not the powdered variety that uses artificial flavoring, actually slows the development of kidney stones for those who are prone to the development of kidney stones.”

Kidney stones have a higher concentration during summer months when heat and humidity are at their highest. Because dehydration is common when it’s hot out, the kidneys don’t have enough fluids to cleanse out of the body and the kidneys start slowing down causing deficiencies and a buildup of chemicals within the kidneys due to dehydration can form painful stones.

If you want to avoid kidney stones just follow these six steps to a healthier you. Keep hydrated with fluids to decrease saturation in your urine, the best fluids to drink are water and lemonade. Iced Tea and sodas are to be avoided because of their mineral (like Oxalate) content. High protein foods like spinach, nuts and rhubarb and high protein diets also contribute to stone formation, as well as an over-consumption (daily dose of over 1,000 milligrams) of vitamin C. High risk adults for kidney stones shouldn’t use large quantities of antacids. If you already have a stone or are prone to kidney stones, taking vitamin B and magnesium should help reverse the formation of new stones and lessen the pain of passing stones through your system.

Some men have likened the pain of kidney stones to child birth—and I’m sure there are women who would refute that claim—however I haven’t had the pleasure of having either a kidney stone or a child so I can’t weigh in. Even though my risk is significantly lower than the average middle-aged man, you can bet I will be refilling my water bottle and adding a lemon wedge from time to time just in case

The vaccine producer Sanofi Aventis stated this week that they will donate 100 million doses of the vaccine against the new H1N1 swine flu to the World Health Organization (WHO) for distribution. The Chief Executive officer for Sanofi, Christopher Viehbacher, stated that the organization can then send the vaccines to the countries that need them most if the decision is made to immunize people against this new strain of flu.

“Exceptional times require exceptional responses.” Vienhacher said. “We need to act responsibly and we all have to play our part. That is the reason why we intend to donate 100 million doses of influenza vaccine to the World Health Organization to help developing countries face the influenza pandemic.”

The World Health Organization has not yet advised nations to proceed with vaccination against H1N1. The flu, which has spread to all regions around the world, is at a stage six pandemic, although a moderate one to date. As of June 15th, WHO has confirmed approximately 36,000 cases of the swine flu globally with 163 deaths, although flu experts say there are almost certainly hundreds of thousands of cases that have occurred.

The companies that make influenza vaccines have finished the production of vaccines for the upcoming season in the northern hemisphere and have started to work on the swine flu vaccine in case it is needed. This vaccine will be given separately from the seasonal flu vaccine—a cocktail of the three most common strains of the flu, which also includes another type of H1N1.

It is not yet clear how easy it will be to produce the vaccine against H1N1 as it has never affected the population before. This means that two doses might be needed to get a full immune response to protect against the illness. WHO has estimated that the vaccine makers could produce up to 4.9 billion pandemic flu shots annually in a best-case scenario, which will still leave some of the world’s 6.5 billion population unprotected, particularly if more than one does is going to be needed.

Sanofi said that it would reserve approximately 10 percent of its output of the vaccines for WHO. The company also said, “In the event that Sanofi Pasteur’s manufacturing facilities become fully committed to the production of pandemic vaccine, the company will also supply this vaccine under a tiered-pricing policy for developing countries.”

Sanofi stated that at full capacity its new factory in Pennsylvania can produce 100 million doses of seasonal influenza vaccine annually and its existing facility can make 50 million doses a year. Sanofi’s French plant can make up to 120 million doses annually.

The company said that it makes 40 percent of all influenza vaccines that are distributed worldwide. Other companies that produce the flu vaccine include Baxter International, Solvay, Novartis AG and GlaxoSmithKline.

When people discuss the ever-rising costs of health care, one of the most common complaints is the sometimes exorbitant price of prescription medicines. For those with multiple medical conditions or the elderly, the costs can become so overwhelming that overseas options are sought or, worst case, patients refrain from necessary treatments in order to pay for other life necessities. In a long-term effort to reduce health care costs for Americans in the most need of such assistance, President Obama took another step in the process of reform by announcing an $80 billion deal with pharmaceutical companies to reduce prescription drug costs.

While the details of the plan were vague, it was noted that the $80 billion savings would occur over the course of the next decade and primarily come at the hands of drug manufacturers to try to help those who fall into the category of Medicare prescription drug coverage that leaves many customers with high costs.

Brand name prescriptions without generic counterparts are the target group of prescriptions, and analysts estimate that senior citizens will benefit most from the savings, with annual decreases in the range of $2,700 to $6,100 per year. But it was reported that implementation of the plan would only occur if Congress passes a comprehensive health care bill.

Speculation began immediately after the announcement, as both sides of the Congressional aisle and the health care reform issue expressed concerns about the plan. Some believe the $80 billion cut will hurt drug companies, but others argue that drug companies will ultimately manufacture alternatives and benefit from the distribution of higher quantities of cheaper medications.

The savings to be had by Americans with serious prescription needs is by far the biggest benefit of the plan, and some say that the U.S. government will be able to take advantage of the savings as well and use it to help pay for the oft-discussed government-sponsored health care plan. However, one pharmaceutical analyst told Kaiser Health News that the government would not benefit greatly; the offer from the drug companies was simply a peace offering to Congress and the Obama administration to clear the air after an early 1990s disagreement with the Clinton Administration.

The official word from White House officials disclosed that the new program would offer brand-name drugs at half price to seniors, a process that would create a $30 billion savings would be recycled into the system to help the industry, while the other $50 billion of the plan would help provide coverage for the uninsured.

More details of the plan should emerge in coming days and months, along with other reform proposals to forward the Obama Administration’s goals of comprehensive health care reform for Americans.

Knee replacement surgery (arthroplasty) is fairly common and is not limited to a profession or gender, though it is generally more prevalent in older patients. Jane Fonda was in the news recently having her left knee replaced and reportedly was using Twitter to keep those interested appraised of her status. She reportedly said that her doctors had said she would regain up to 80 percent of former mobility.

There are an estimated 500,000 total knee replacements each year in this country, costing over $11 billion collars. That number is expected to be seven times greater by 2030 because of the overweight, aging population. Knee replacement is normally performed to reduce pain and to restore mobility to the affected joint with nine out of ten knee replacements considered successful.

According to a recent cost effectiveness report, the procedure, though expensive would be worth it for those with long-term knee problems associated with osteoarthritis. Researchers at Brigham and Women’s Hospital and the Boston University School of Public Health reviewed the cost effectiveness of operations performed on Medicare patients aged 65 and older. According to the study, knee replacement surgery and subsequent costs averaged $57,900 per patient. This was $20,800 more than was spent on those who did not have the surgery. Those who had replacement knees lived in good health more than a year longer than those who did not, and the researchers calculated the added cost per year of good quality life at $18,300. Judged against other procedures to treat aging bones it was “highly cost effective.”

The cost effectiveness of the surgery was generally higher at high-volume hospitals with experienced surgeons. Blacks, Hispanics, and older patients did not generally receive the same benefits, according to the study. Researchers reported “For patients who choose to undergo total knee arthroplasty, hospital volume plays an important role: regardless of patient risk level, higher volume centers consistently deliver better outcomes.”

Stephen Lyman of Weill Cornell Medical College in New York said in an editorial that translating cost-effectiveness to medical practice was an uphill climb. “At least in the United States, even well performed cost-effectiveness analysis do not influence either payers or physicians directly. Payers do not use the results to make coverage determinations nor do physicians use them to make treatment decisions.” Lyman wrote.

The study appears in the June 22 issue of the Archives of Internal Medicine.