Heart(y) News, Dec 10: Medical Devices Updates

Phone it in: Remote monitoring could offer peace of mind for patients with “recalled” ICD leads

What a bummer when the implanted cardioverter defibrillator (ICD) inside you and is supposed to regulate your heart’s rhythm suddenly malfunctions or even “recalled” for safety reasons.  The well-publicized recall of Medtronic ICD leads made a lot of patients worried. That is why some measuring of monitoring ICDs is in place but it is costly and impractical to have the patient come in regularly for checks. So why not a monitoring from remote? ICDs are electronically controlled so it must be possible to insert a small chip to monitor the function of the device and transmit it to a data center. Remote monitoring can also assuage the fears associated with ICDs and “ give many patients some welcome reassurance about having a device in the first place, a sense that they’re being closely watched.”
Freedom® Portable Driver Surpasses 1,200 Days of Patient Life

A total of 19 patients are using Syncardia’s Freedom® Portable Driver to power its Total Artificial Heart while waiting for a heart donors – some outside the 4 walls of the hospital. Many of these patients are leading a normal life of family, eating out and physical exercise. The driver now “accounts for more than 1,200 days of patient life.”

Federal report linking Dr Mark Midei and Abbott finds “potential fraud, waste, and abuse”

The case against against the “superstenter” Dr. Mark Midei has taken a different turn. Dr. Midei was accused of implanting unneeded stents while working at the St Joseph Medical Center in Maryland. Whereas he was previously portrayed as an innocent victim, there are now indications of “potential fraud, waste and abuse.” A US Senate Finance Committee report claims to have found financial links between Dr. Midei and Abbott, the stent’s manufacturer. The report continues to show that Midei was one of the highest users of Abbott’s stent in the US Northeast and had at one time implanted 30 Abbott stents in 1 day. Midei was supposed to have received some “incentive” gifts from the company.

Health care updates, Nov 19

Vaccine for Ear Infections
Ear infections are common among babies and little children and some of these infections are caused by pneumococcal bacteria. Scientists have developed a vaccine that is active against 7 pneumococcal bacterial strains. The PCV-7 vaccine has been tested in 177,000 kids where 20% reduction in the number of cases was observed. The vaccine has been approved in 2007 but it is only now that its real benefits come to light. Babies receive four doses of the vaccine at age two months, four months, six months and again at 12 months.    

FDA clears Cymbalta to treat chronic musculoskeletal pain
The US FDA has recently approved a new indication for Cymbalta (duloxetine hydrochloride). It can now be prescribed for the treatment of chronic musculoskeletal pain, including pain from osteoarthritis and chronic lower back pain. Cymbalta was already approved for diabetic peripheral neuropathy in 2004; generalized anxiety disorder and maintenance treatment of major depression in 2007; and fibromyalgia in 2008.

FDA launches initiative to develop innovative external defibrillators
Automated external defibrillators (AEDs) can now be found in many public areas. They are to be used in cases of emergency in people suffering from cardiac arrest. The U.S. Food and Drug Administration has recently launched a program aimed at “facilitating the development of safer, more effective external defibrillators used to treat abnormal heart rhythms through improved design and manufacturing practices.”
AEDs are designed that they can be used by a bystander who has no previous experience in first aid or use of the device. AEDs help save lives every year but there have also been reports of device failure. The initiative should increase the safety and usability of AEDs.

FDA Urges Consumers to be ‘Smart’ about Antibiotic Use
Antibiotics are often misused, with serious, long-lasting consequences- bacterial resistance. Antibiotic resistance occurs when bacteria mutate and this mutation reduces or eliminates the effectiveness of antibiotic drugs.

The US FDA is urging consumers to use antibiotics appropriately. Here are some of their recommendations:

• Don’t skip doses and take your medicine as prescribed. Antibiotics are most effective when taken as prescribed.
• Don’t save antibiotics. The drug is meant for a particular infection at that time. Don’t use leftover medicine. Taking the wrong drug can delay the appropriate treatment and your infection might get worse.
• Don’t take antibiotics prescribed for others. Only a health care professional can determine the right treatment for your infection.

Diabetes News, Nov 5: Lifestyle interventions for diabetes

In observance of the National Diabetes Month in the US, we bring you the latest  diabetes updates.

Fruit and vegetable intake and incidence of type 2 diabetes mellitus: systematic review and meta-analysis
The majority of nutritional studies on diabetes focus on carbs and carb intake. Where fruit and vegetables come in? Does eating fruit and vegetables really help in managing type 2 diabetes mellitus (T2DM)? This is the question that British researchers wanted to answer. So they conducted a review of studies on the benefits of diet rich fruit and vegetables for people with diabetes. Their findings show that there was no marked benefit from increased fruit and veggie intake. However, looking at the different types of vegetables, green leafy vegetables such as spinach and lettuce are actually good diabetes fighter. The study concluded:
Increasing daily intake of green leafy vegetables could significantly reduce the risk of type 2 diabetes and should be investigated further.

The China Da Qing Diabetes Prevention Outcome Study
What about diet plus exercise? Chinese researchers investigated how 3 types of lifestyle intervention perform in managing diabetes-associated microvascular complications such as retinopathy, nephropathy and neuropathy. The interventions consisted of diet, exercise, and diet plus exercise and lasted for 6 years. The patients were followed up for up to 20 years. The study results showed:
“Lifestyle intervention for 6 years in IGT was associated with a 47% reduction in the incidence of severe, vision-threatening retinopathy over a 20 year interval, primarily due to the reduced incidence of diabetes in the intervention group.”

Long-term effects of a lifestyle intervention on weight and cardiovascular risk factors in individuals with type 2 diabetes mellitus: four-year results of the Look AHEAD trial
The Look AHEAD (Action for Health in Diabetes) is a large, long-term study that investigated the long-term effects of lifestyle approaches on T2DM. The study compared the effect of 4 years of intensive lifestyle intervention (dietary change and physical exercise) vs. standard diabetes care. The results showed that those who underwent lifestyle change lost more weight, and had better improvements in blood glucose levels, blood pressure and lipids than those who had standard treatment. the authors concluded:
“Intensive lifestyle intervention can produce sustained weight loss and improvements in fitness, glycemic control, and CVD risk factors in individuals with type 2 diabetes. Whether these differences in risk factors translate to reduction in CVD events will ultimately be addressed by the Look AHEAD trial.”

Health care news, October 15

October 10 was World Mental Health Day
This year’s theme is “a continuation of the one on integration of physical and mental health from last year, with a specific focus on the relationship of mental health with chronic physical illnesses.”

Despite highest health spending, Americans’ life expectancy falls behind other countries’
Researcerhs at the Columbia University’s Mailman School of Public Health compares poorly in terms of life expectancy relative to other developed countries. It is not that conditions in the US did not improve between 1975 and 2005. In fact, the US did achieve gains in survival rates. But these gains are far behind other developed countries. This despite the highest health care spending per capita of all the countries surveyed. We’ll take a look at this study in detail in an upcoming post next week.

Whooping cough vaccine to be required of California seventh-through-12th-graders
Due to increased incidence of pertussis (whooping cough) in California recently, the golden state passed a new law that requires 7^th to 12^th graders to have booster shots before start of the school year in fall 2011. California experienced the worst pertussis epidemic this year, with at least 5,272 confirmed cases and nine mortalities (mainly infants). Before the state bill was signed last week, “California had been one of only 11 states that did not require middle school students to get a booster shot against whooping cough, or pertussis.”

FDA on Flickr and Facebook
What the F? Yes, FDA is really getting serious about social media. It is also now on Facebook and Flickr.

Infant Sleep Positioners Pose Suffocation Risk
A consumer update from the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC) warns against the use of baby positioned due to risk of suffocation. There were 12 reported cases of fatal infant suffocation during the last 13 years. Consumers are advised to

STOP using infant positioning products. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary.

NEVER put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.

ALWAYS place a baby on his or her back at night and during nap time.

REPORT an incident or injury from an infant sleep positioner to the Consumer Product Safety Commission by visiting www.cpsc.gov/cgibin/incident.aspx5 or calling 800-638-2772, or to FDA’s MedWatch program.

Coming up October Events:

11 – 15 October
US National School Lunch Week
www.schoolnutrition.org/nslw

12 – 20 October
Bone and Joint Decade National Action Week
www.usbjd.org

Cancer in the headlines, September 17

Medical summit to focus on pediatric cancer fight‎
The bipartisan Congressional Pediatric Cancer Caucus was founded last year and convened this week, Sept. 16, in Washington for the Childhood Cancer Summit. Among those who will be joining US lawmakers in the summit are top doctors and researchers from all over the US, from such well-known institutions like Memorial Sloan Kettering in New York, Houston’s M.D. Anderson and Texas Children’s Hospital and Children’s Hospital of Philadelphia. To be discussed are “how we can overcome the obstacles to drug development and access to treatments, and how we can ensure a better quality of life for those who survive their fight with pediatric cancer… The summit is critical in raising the level of awareness, not just among the general public, but also among policymakers. Our goal is to fashion the recommendations from our experts into a legislative agenda and gain the support of our colleagues in the House and Senate.” The summit is part of the September observance on Childhood Cancer Awareness.

Breast Cancer Action will be turning 20 this year!
The Breast Action Group (BCA) will be turning 20 will be celebrating 20 years of activism on October 7th 2010. Check out for the schedule of schedule of activities on the BCA website. As a birthday present to BCA, you can sign the petition telling Eli Lilly to Stop Milking Cancer. Each signature counts!

Cancer features at the 6^th Zurich Film Festival
The 6^th Zurich Film Festival starts next week and cancer is a hot issue during this festival. For one thing, Michael Douglas is a special awardee for his film Wall Street but unfortunately cannot make it to the vents as he is undergoing cancer treatment. Then there is the 93-minute German-Language feature film Stationspiraten (Station Pirates) by Michael Schaerer. Here is a synopsis of the film:

“Five adolescents meet on a hospital’s cancer ward. Four of them have received a positive diagnosis; one is still awaiting his results. Although each of them suffers from a different kind of cancer, all of them face an uncertain future. Friendship has always played an important role in the lives of young people but is absolutely indispensible when your most impressionable years are spent dressed in pyjamas and hooked up to tubes. Despite their circumstances, the lively quintet manages to find a positive side to the monotony of everyday hospital life, and oppose their threatening illness by enjoying their lives to the full. Yet, each one of them must still cope with their own situation and problems.”

Check out the trailer. You might not understand the language (Swiss German) but you’ll be sure to shed some tears.

Obesity updates: mostly bad news for anti-obesity drugs

Today, I am bringing you the latest research updates on drugs for obesity. Unfortunately, it is not all good news.

New research finds no evidence that popular slimming supplements facilitate weight loss
German researchers who evaluated the effectiveness of a broad selection of popular slimming supplements arrived at the disappointing conclusion that none of them helps with losing weight any more than placebo. They presented their results at the International Congress on Obesity in Stockholm, Sweden last month.

According to study leader Dr. Thomas Ellrott, head of the Institute for Nutrition and Psychology at the University of Göttingen Medical School, Germany:

“There are scores of slimming supplements out there claiming weight-loss effects through all sorts of mechanisms of action. We have so-called fat magnets, mobilizers and dissolvers, as well as appetite tamers, metabolism boosters, carb blockers and so on. The market for these is huge, but unlike for regulated drugs, effectiveness does not have to be proven for these to be sold. Few of these supplements have been submitted to clinical trials and the landscape of products is always changing, so we need to put them through rigorous scientific evaluation to determine whether they have any benefit.”

Anti-obesity drugs unlikely to provide lasting benefit according to scientists
Even clinically tested drugs prescribed for obesity cannot provide long-lasting benefits for those with weight problems, according to British scientists. These drugs “fail to provide lasting benefits for health and wellbeing because they tackle the biological consequences of obesity, and not the important psychological causes of overconsumption and weight gain.”

Rise in weight-loss drugs prescribed to combat childhood obesity
The number of young people prescribed anti-obesity drugs has increased 15-fold since 1999, according to a 2009 report. Most of these drugs have not been approved for use in patients under 18, yet are commonly prescribed “off-licence”, according to a British study. Most of these young people, however, stop taking the medications before effects can be measured.

According to study author Dr. Russel Viner of General and Adolescent Paediatrics Unit at University College London:

‘It’s possible that the drugs are being given inappropriately, or that they have excessive side effects that make young people discontinue their use. On the other hand they could be expecting the drugs to deliver a miracle ‘quick fix’ and stop using them when sudden, rapid weight loss does not occur.”

Experimental obesity drug avoids brain effects that troubled predecessors
On a more positive note, Danish researchers report about a promising new obesity drug that seems to have less psychological effects. The anti-obesity drug rimonabant was withdrawn from the market due to strong psychiatric effects that may have been linked to suicide. The new drug is a CB1 receptor blocker like rimonabant but of the second generation and was designed to target peripheral tissues only and thus does not affect the brain. So far, the drug has only been tested in animals but the results show a lot of promise.

Health care updates, August 20

CDC Expert Commentary: Could You Treat 270 Patients in Two and a Half Hours?
In a recent commentary on Medscapre, Dr. Richard C. Hunt, the director of Centers for Disease Control and Prevention (CDC) Injury Center’s Division of Injury Response describes the CDC’s experiences during simultaneous terrorist attacks that result in a large number of trauma patients within a short period of time. He describes as an example the attacks in Madrid in 2004 when 10 terrorist explosions went off almost simultaneously on the city’s commuter trains. The victims were taken to the nearest hospital s and in one hospital, a total of 270 injured patients arriving within 2 and a half hours. Health care services are usually not prepared for this large number of trauma patients.

FDA approves ella™ tablets for prescription emergency contraception
The “morning after” tablet ella™ (ulipristal acetate) has finally been approved by the US FDA. Ella is progesterone agonist/antagonist indicated f or emergency contraception. It supposedly delays ovulation and prevents pregnancy when taken within 5 days of a contraceptive failure or unprotected intercourse. The drug has been available since May 2009 in Europe where it is marketed as ellaOne. Ella is only available with prescription.

NIH Seeks to Break New Ground in Reducing Health Disparities
The National Institutes of Health launched earlier this month a multidisciplinary network of experts who will explore new approaches to understanding the origins of health disparities. The Network on Inequality, Complexity, and Health (NICH).will consist of experts from different fields and disciplines. According to Dr. Deborah H. Olster, acting director of NIH’s Office of Behavioral and Social Sciences Research (OBSSR):

“NICH brings together scientists from many different disciplines to create a new conceptual approach for examining the behavioral, social and biological factors which interact to cause inequalities in health.”

Accelerating Electronic Health Records Adoption and Meaningful Use
The widespread meaningful use of electronic health records(EHR)  by 2014 is the goal of the US Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH). The regulations of the federal program announced in July

FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal
The US FDA has issued warning about the anti-seizure drug Lamictal (lamotrigine). The drug, which is indicated for the management of seizures and bipolar disorder, “can cause aseptic meningitis, an inflammation of the protective membranes (meninges) that cover the brain and spinal cord not caused by bacterial infection.” Lamictal is manufactured by GlaxoSmithKline.

Health care updates, July 16

Contraceptive Use: New Clinical Guidance From the CDC
The Centers for Disease Control and Prevention (CDC) recent issued new guidelines on the use of contraceotives. The gudeilnes are basically similar to those of the World Health Organization except for a few modifications. However, some experts question the information on the label on deep venous thrombosis and the use of progestin-based methods.

FDA Approves First Generic Effexor Extended Release Capsules to Treat Major Depressive Disorder
The US FDA approved the first generic version of the widely used anti-depressant Effexor (venlafaxine hydrochloride). According to Dr. Keith Webber, deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research:

“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs. Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”

Study finds health insurance inequities for same-sex couples
California is one of the states which are progressive when it comes to sexual orientation. However, a recent UCLA study showed that even in the golden state, many employers still discriminate in providing health care coverage to same-sex partners.
According to study author Ninez A. Ponce ,associate professor at the UCLA School of Public Health:

“We found no strong evidence to suggest that California employers are discriminating in providing health insurance to gay and lesbian workers as individuals. However, we did find that employers were setting coverage rules for dependents that favored legally and heterosexually married employees.”

Center for Devices and Radiologic Health Using Twitter
The US FDA’s Center for Devices and Radiological Health is also now on twitter. Tweets are targeting health professionals and includes recalls, approvals, other safety information, upcoming meetings and new and updated guidelines.

New AHRQ Guides Offer Hospitals Advice on Emergency Evacuation, Assessment and Recovery
What happens when a hospital is in the epicentre of any earthquake or the target of a terrorist attack? The helfers become the victims and the patients in the hospital become victims, too. This is the scenario that is addressed by 2 new guidelines of the U.S. Department of Health and Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ). The guidelines will help “hospital planners and administrators make important decisions about how to protect patients and health care workers and assess the physical components of a hospital when a natural or manmade disaster, terrorist attack, or other catastrophic event threatens the soundness of a facility.”

Heart(y) news, July 2

FDA reviews olmesartan safety record, cites CV deaths in trials
Here is another safety issue regarding angiotensin receptor blockers (ARBs). Or at least one of them. Olmesartan (marketed in the US as Benicar by Daiichi Sankyo). Data from the two trials ROADMAP and ORIENT suggest that an excess of cardiovascular risk involved in the use of olmesartan in patients with diabetes. The US FDA is conducting a review of the data.

“FDA plans to review the primary data from the two trials and the total clinical-trial data on olmesartan. Also, the agency will evaluate additional ways to understand the findings from ROADMAP and ORIENT, in light of information supporting the use of ARBs and angiotensin-converting enzyme (ACE) inhibitors in certain patients at high risk for cardiovascular events.”

Use of oxygen in MI patients questioned by new Cochrane review
Patients suffering from acute myocardial infarction (heart attack) do not necessarily need inhaled oxygen, according to a recent Cochrane review. Because a heart attack is caused by lack of oxygen supply to the heart, it has always been thought that giving extra oxygen helps. However, this belief is now being questioned as the review revealed that there is no clinical evidence to support this practice.

“While it may seem like common sense, sometimes these things are not beneficial. Cardiology is littered with examples where an intervention has seemed like a good idea in theory, but when large trials are done it has turned out to be of no benefit or even harmful, like the prophylactic use of antiarrhythmics.”

Myocardial strain measured by echo detects cardiotoxicity of cancer drugs early
Chemotherapy comes with a lot of side effects. One of the side effects of breast cancer therapy is cardiac dysfunction. A recent study reports that the probability of this side effect to occur can be predicted by echocardiography (ECG) and biomarkers in the blood for heart disease. The results were presented at the American Society of Echocardiography 2010 Scientific Sessions last June 13, 2010 in San Diego, CA. The blood tests measured N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hsTnI), and the echocardiograms measured left ventricular ejection fraction (LVEF) as well as peak systolic myocardial radial and longitudinal strain.

Giving birth many times linked to increased risk of heart disease
The more children she delivers, the higher is a woman’s risk for heart disease. Parity – which is the number of times of delivery was measured in Palestinian women living in refugee camps. The results showed that “parity is linked to obesity, high blood triglyercide concentrations, and increased risk of metabolic syndrome. Any of these factors, alone or in combination, can in turn increase incidence of coronary heart diseases.”

Heart(y) news, June 25

EMEA to review ARBs and cancer, infuriating experts, who point to missing data and adverse consequences
A few days ago, I posted a piece on blood pressure pills angiotensin-receptor blockers (ARBs) being associated to increased risk of getting cancer based on a paper recently published in Lancet Oncology. The European regulatory body European Medicines Agency (EMEA) just announced today that it plans to conduct a review of the safety of ARBs as a response to the said report. However, not all health experts are convinced about the data presented in the paper, even some declaring the paper to be “deeply flawed.” However, there are also those who believe the authors have the right to publish their data and that the risks should be investigated further. So far, EMEA is the first regulatory agency to react to the paper and the authors are also asking the FDA to respond.

“The bottom line is that our data are solid, and we are calling for a review by the FDA because there is so much at stake here. The FDA has to look into this, they have the ball now.”

Uninsured Americans have 50 percent higher odds of dying in hospital from heart attack or stroke
Another report points out the health disparities and thus highlights the importance of the much-needed health care reform in the US. The paper looked at more than 150,000 patients discharged from hospitals and came to the conclusion that there are disparities in terms of hospital mortality, length of hospital stay and costs which can be attributed to differences in health insurance coverage. The uninsured are more likely to die from acute myocardial infarction and stroke than those who are privately insured. Patients on Medicaid are more likely to stay longer at the hospital with higher hospital costs for stroke and pneumonia. According to lead author Dr. Omar Hasan of Harvard Medical School and Brigham and Women’s Hospital in Boston:

“The new healthcare bill will bring vast changes to the insurance status of millions of Americans, and we hope that our work will provoke policymakers, healthcare administrators, and practicing physicians to consider devising policies to address potential insurance related gaps in the quality of inpatient care.”

Cholesterol Recommendations: US/International Guidelines at Odds
Guidelines are meant to help standardize healthcare. Unfortunately, this doesn’t always work, especially at the international level. The Life Science Research Organization, Inc. (LSRO) recently published a review paper that shows that the US daily dietary recommendations for cholesterol are not consistent with current international guidelines. International guidelines recommend “reducing total fat intake and shifting to unsaturated fats from saturated and trans fats.” The US recommendations focus more on cholesterol intake (<300 mg/d for the general population and <200 mg/d for those with elevated LDL) as a risk factor for coronary heart disease. Although both sets of guidelines do not necessarily contradict each other, the paper points out that dietary recommendations stated in technical language are confusing, and that “numerical recommendations can cause undue focus on one food or nutrient over another with potentially adverse, unintended consequences.”

Cancer in the headlines, June 18

Take the Cancer Risk Check online at MD Anderson
What is your likelihood of getting cancer. Calculate your cancer risk online using the MD Anderson Cancer Risk Check. It checks for a woman’s risk for breast and cervical cancer, a man’s risk for prostate cancer, colorectal cancer and skin cancer. It takes into consideration gender, ethnicity, family history, diet and physical exercise. After your cancer risk is calculated “you’ll receive customized suggestions for lifestyle changes and cancer screening exams that may help you prevent cancer.”

COST AND CANCER

Cost concerns prevent many cancer survivors from getting medical care
Cost is a barrier to getting medical care to about 2 million cancer survivors in the US. This is according to researchers who analyzed data from the US National Health Interview Survey (NHIS). Cancer survivors are more likely to delay or skip medical check ups than those without cancer despite the fact that survivors have special medical needs for many years. A breakdown of the prevalence of foregoing medical care among survivors is as follows:

• 7.8% for medical care
• 9.9% for prescription medications
• 11.3%for dental care
• 2.7% for mental health care

Medicare cuts increase cancer treatments, study finds
Interestingly enough, less money doesn’t always mean less health care, according to a study by researchers at Harvard Medical School. Certainly not in cancer treatment. Since the passage of the 2005 Medicare Modernization Act, the rate of chemotherapy treatments actually increased despite the reduction of Medicare reimbursements to doctors. This paradox may be puzzling to some but not to economists. But this is only true for chemotherapy wherein doctors purchase the drugs and get reimbursed by health insurance providers. This doesn’t or wouldn’t apply to prescription drugs that patients have to fill and pay for.

NEW CANCER TREATMENT APPROVALS

FDA Approves New Treatment for Advanced Prostate Cancer
This week, the US FDA approved Jevtana (cabazitaxel), a chemotherapy drug for prostate cancer. Cabazitaxel is approved in combination with the steroid prednisone. It is the “first treatment for advanced, hormone-refractory, prostate cancer that has worsened during or after treatment with docetaxel, a commonly used drug for advanced prostate cancer.” Jevtana is marketed in the US by Sanofi-Aventis based in Bridgewater, N.J.

FDA Approves New Indication for Tasigna
Tasigna (nilotinib) is now approved for the treatment of a rare form of blood cancer called  Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML) caused by a genetic abnormality. The safety of Tasigna was initially questioned due to adverse cardiovascular effects. Tasigna is marketed in the US by Novartis Pharmaceuticals based in East Hanover, N.J.

Healthcare updates, June 18

Men’s Health Week: AHRQ and Ad Council Encourage Men To Take Preventive Steps in Their Health Care
For most men, health usually takes the back seat. They lag behind women when it comes to taking care of themselves. According to the Agency for Healthcare Research and Quality (AHRQ), compared to women, men are 24% less likely to see a doctor but 30% more likely to be admitted to a hospital for conditions that are preventable. June 16 to 19 is Men’s Health Week and health authorities are trying to “to raise awareness among middle-aged men about the importance of preventive medical testing”, in time for Father’s Day on June 20.

World Elder Abuse Awareness Day
Last Tuesday June 15 was World Elder Abuse Day. According to the Centers for Disease Control and Prevention (CDC), abuse of the elderly is a significant public health problem not only in the US but worldwide. In the US alone, more than 500,000 people aged 60+ are mistreated, neglected, or become victims of violence every year.

FDA Fines American Red Cross $16 Million for Prior Failures to Meet Blood Safety Laws
It’s not only big pharma companies which get fined. Not-for-profit organizations also run into trouble with health authorities. The US FDA recently fined no other than the American Red Cross for non-compliance of blood safety laws. And such a hefty fine, too. $16.18 million: “$9.79 million for violations related to mismanagement of certain blood products and $6.39 million for Good Manufacturing Practice violations. Blood products include red cells, plasma and platelets.”

The Reality of Drug Shortages — The Case of the Injectable Agent Propofol
Propofol is making headlines again. This time, it is not being implicated in a high-profile death. There is currently a shortage of the popular injectable sedative-anesthetic. Only 3 companies are manufacturing propofol and 2 of them had recalls, thus leading to short supply. The issue of drug shortages in general, and the case of propofol in particular is discussed in an article in the recent issue of the New England Journal of Medicine.

The urgent need for US malpractice reform
An article in the Journal of the American College of Cardiology is calling for major changes in US malpractice legislations. The current system, according to the authors led by cardiologist Dr James Dove of Prairie Cardiovascular Consultants, Springfield, IL, is very expensive and hard emotionally and psychologically on the doctors. They believe that about 70% of malpractice cases are unjustified. “Defensive medicine affects all practicing physicians who are acutely aware that behavior patterns based on the fear of litigation often add little to the care of the individual patient but add greatly to the financial costs to society.”

Cancer in the headlines: cancer drug updates, June 11

Popular cancer drug can cause kidney damage
The drug bevacizumab is an anti-VEGF agent widely used in tumor treatments. Recent data however reveals that the cancer drug causes proteinuria (loss of protein from the kidney) and kidney damage. Patients on bevacizumab have an almost five-fold increased likelihood of having severe proteinuria and an almost eight-fold increased risk for nephritic syndrome. It is recommended that patients should be closely monitored for kidney-related side effects.

Combining Two Competing Cancer Drugs, Study Finds Rare 100% Response Rate
The new trend in pharmacologic cancer treatments are the so-called “boutique” treatments which target a small portion of a patients but so effective is the target that an almost 100% efficacy can be achieved. An example is a drug being developed by Pfizer which targets only 4% of lung cancer cases but with very high response rates. Another trend is to combine two drugs from competing companies to form a highly effect cocktail. An example is the joint venture of Takeda and Celgene.

Cetuximab less effective in simple tumors
The cancer drug cetuximab is approved for the treatment of metastatic colon cancer. However, the drug seems to be less effective in simpler tumors in less advanced stage. This is according to study conducted by researchers at the Mayo Clinic. The findings are puzzling and warrant further research. According to trial leader Dr. Steven Alberts, oncologist at the Mayo Clinic:

“It is difficult to understand how an agent that helps patients with metastatic cancer is not beneficial to those with less advanced disease. At this point we are focusing our efforts on identifying a biological explanation for these findings.”

Inhaled drug may prevent lung cancer
Iloprost is a drug indicated for pulmonary hypertension, scleroderma, and Raynaud’s phenomenon. It is administered through inhalation. Researchers at the Denver Veterans Affairs Medical Center tested whether the drug in oral form can prevent smoking-related lung cancer. TH early results look very promising. According to the study authors:

“Oral iloprost showed promise for preventing lung cancer in former, but not current, smokers in a phase II clinical trial.”

Compound enhances cancer-killing properties of agent in trials
An experimental drug called ARC is currently being tested for cancer treatment. Researchers report that adding a second agent called ABT-737 can increase the efficacy of the two drugs. The two drugs seem to work in synergy so that lower concentrations are necessary to achieve optimal efficacy. Lower doses, in turn, result in fewer side effects.

Cancer in the headlines, June 4: breast cancer news

Peaches, plums induce deliciously promising death of breast cancer cells
What do peaches and plums have in common aside from being yummy? They are great as cancer cell fighters! Researchers at Texas AgriLife Research report that extracts from these two fruits make even the most aggressive breast cancer cells “keel over”. The anti-cancer powers of these two fruits are attributed to phenolic acids. More about these, next week.

Bone drug suppresses wandering tumor cells in breast cancer patients
Zoledronic acid (marketed as Zometa) is a drug prescribed to strengthen bones. But researchers at the Washington University School of Medicine in St. Louis report that this drug can also be beneficial for patients with metastatic breast cancer. “When the drug was given along with chemotherapy for three months before breast cancer surgery, it reduced the number of women who had tumor cells in their bone marrow at the time of surgery.”

Olive-oil enriched diet helps breast cancer survivors lose more weight
Olive oil is well-known for being a heart-friendly oil. Miriam Hospital researchers report additional benefits of this oil – inducing weight loss in breast cancer survivors. Brest cancer patients are prescribed low-fat diet to control weight because weight increase in these patients elevates the chances of cancer recurrence. The researchers report that a diet rich in olive oil is more likely to help weight loss than the standard calorie-poor diet.

Breast cancer genes not worsened by lifestyle
So you have the genetic predisposition for it. Does lifestyle make a difference? Researchers at the Cancer Epidemiology Unit at the University of Oxford say that lifestyle factors do not increase the risk for genetically-determined breast cancer. That doesn’t mean to say that you shouldn’t care about your lifestyle. Say lead author Ruth Travis:
“There’s a danger of feeling you’re at the fate of your genes. But whatever you’re born with, there are things you can do to modify your risk.”
Unhealthy lifestyle may not elevate your risks but a healthy one might help lower them. Think about it.

UT Southwestern unveils next generation CT scanner that views whole organs in a heartbeat
After all the recent safety issues of CT scans, this new generation scanner launched recently at UT Southwestern Medical Center is very much welcome because it is fast. The new scanner allows “doctors to image an entire organ in less than a second or track blood flow through the brain or to a tumor – all with less radiation exposure to patients.” Radiation from CT scans are believed to increase cancer risk, including breast cancer in women.

Health care updates, June 4: what’s going on in hospitals

New docs linked to death spike in July
Deaths  due to medical errors are highest in July in the US and the reason for this, according to  researchers at the University of California in San Diego is the influx of new medical residents at this time of the year.
July is the month when new residents start to get more responsibilities for patient care with less supervision. During this month, cases of medical errors (e.g. drug overdose and mix-ups, surgical mistakes, etc.) peak – 10% higher than in other months. This increase is especially evident in teaching hospitals and is not reflected in increased death rates in the general population. More about this next week.

Mail-Order Pharmacy Use Could Improve Patients’ Medication Adherence
Many of us associate buying medications online as dangerous, not to mention stupid, due to our experience with all the email spams and scams we receive every day. But there are some bonafide mail-order pharmacies out there, and these providers, according to a new study, actually help patients to comply with their pharmacological therapies. Researchers at Kaiser Permanente looked at patients who use the center’s personal electronic health record, My Health Manager, which allows patients to view online lab results, refill prescriptions, schedule appointments and send secure emails to their doctors. The results showed that patients are more likely to adhere to medication regime when medications are sent by mail than those who have to pick up their medication refills personally.

“Our findings suggest that there is a lot that health care systems can do to provide support that makes it easier for patients to take care of themselves and do the right thing.”  

Stanford/Packard study finds surprising disparity in where chronically ill kids hospitalized
Chronically ill children need specialized pediatric care, yet a California study showed that provision of this type of care varies widely. For example, children from San Francisco and San Mateo counties are more likely to be admitted to a pediatric specialty-care center than children from neighboring countries. What is even more interesting is that fact that children with private insurance are actually less likely to received specialized care than those with public insurance. In 2007, for example, 67% of pediatric beds at pediatric specialty care centers were occupied by publicly insured patients. The reasons for this disparity are not clear and might be very complex.

Innovative Software Cuts Costs and Time for States to Report Hospital Quality Information to the Public
Meet MONAHRQ—My Own Network Powered by AHRQ—a free, MS® Windows®-based software application just launched by the Agency for Healthcare Research and Quality (AHRQ).  The software supposedly “significantly reduces the cost and time a State, hospital or other organization would need to spend to compile, analyze and post data on quality of hospital care, its cost and how that care is used. MONAHRQ allows users to create a customized Web site with data that can be used for internal quality improvement or reporting quality information to the public.”

Cancer in the headlines, May 28

No Evidence Linking Cell Phone Use to Risk of Brain Tumors, according to FDA, WHO
A consumer health information advisory from the US FDA says that mobile phone use does not increase risk for brain cancer. The advisory is based on the latest data from the Interphone study published June 2010 issue of the International Journal of Epidemiology. The World Health Organization (WHO) also issued a similar statement. Does this settle the issue once and for all? We’ll bring you more on this next week.

Novartis: Ovarian cancer drug disappoints in trial
A big disappointment for pharmaceutical giant Novartis. The anti-cancer drug patupilone may be effective against ovarian cancer but it is not better than any drugs currently in the market. Under these circumstances, the likelihood of approval for this indication is unlikely. According to the company:
“Novartis does not plan to proceed with regulatory filings based on these data.”

Research Shows Surgical Procedure Offers New Option for Pediatric Patients with Rare Cancer in Abdomen
A surgical intervention meant for adults but was adapted for pediatric patients is reported to improve survival of children with rare tumors in the abdomen. The procedure called hyperthermic intraperitoneal chemotherapy (HIPEC) or “heated chemotherapy” was used in 24 pediatric patients which resulted in an overall 3-year survival rate of 71%. This is significantly higher than the 26% survival among those who received standard treatment.

Hospital wins suit after man got uterine cancer
The NYU Langone Medical Center won the malpractice suit filed by the widow of a man who contracted cancer after undergoing kidney transplant at the hospital. The donor kidney was taken from a deceased stroke victim whose uterine cancer was only discovered 6 weeks later. Although the hospital advised the patient of the risks of keeping the organ, he decided to keep it for 6 months. The jury decided in favor of the hospital. This is probably the only case of uterine cancer to be transmitted through an organ transplant.

Effect of reduced immunosuppression after kidney transplant failure on risk of cancer
Patients have to undergo immunosuppression after organ transplants to lower the chances of rejection. However, due to suppressed immunity, these patients have a higher risk for developing cancer. Australian researchers report that incidence of certain cancers increase during immunosuppression after kidney transplant. However, the incidence decreases when immunosuppression (e.g. in cases of transplant failure) is stopped, e.g. the effect of immunosuppression seems to be reversible. These cancers are non-Hodgkin’s lymphoma, lip cancer, and melanoma.

Heart(y) News, May 28: updates on implants and devices

Mayo Clinic Discharges 1st SynCardia Total Artificial Heart Patient in U.S. History
This patient just made history when he became the first patient in the US to walk away from the hospital with a SynCardia temporary Total Artificial Heart . 43-year old Charles Okeke, husband and father of three could go home while waiting for a matching heart donor, thanks to the Freedom™ driver, the first ever U.S. portable driver designed to power SynCardia’s Total Artificial Heart both inside and outside the hospital. The driver weighs only 13.5 lbs and can be carried in a backpack or shoulder bag. Okeke is one of the lucky few to be part of the trial testing the driver.

Reused pacemakers safe, effective in meta-analysis
Almost everything is reused and recycled nowadays, so why not pacemakers? Just, that’s right. Those little implants that keep the heart ticking. Researchers at University of Michigan removed pacemakers from deceased patients, sterilized them, and used them in patients who cannot afford to pay for these devices. The results are very positive, with no increased occurrence of infection, device malfunction or other side effects were observed. According to the researchers:
“Pacemaker reuse is a safe, efficacious, and ethical alternative to address the medical needs for those in Third World countries who could not afford therapy otherwise.”
The study looked only at pacemakers but not at ICDs.

Henry Ford Hospital study: Fewer infections with new heart-pump implant
A new heart pump model indicated for end-stage cardiac patients significantly lowers  the risk for infection, according to researchers at the Henry Ford Hospital in Detroit. HeartMate II is a newer model of the left ventricular assist device HeartMate that is less invasive and thus the patient is less prone to infection. HeartMate was approved by the US FDA in February this year.

HRS issues guidance on tough device-withdrawal issues
The Heart Rhythm Society (HRS) has spoken and issued a first-of-its-kind consensus statement regarding the pacemakers or implantable cardioverter-defibrillators (ICDs) of terminally ill patients. The issue especially addressed the withdrawal or refusal of life-sustaining devices such as pacemakers or ICDs by dying patients. According to the guidance by HRS and its collaborators from other groups and countries:

“Patients (and their surrogates) have the right to refuse or withdraw any life-sustaining treatment including [cardiovascular implantable electronic device] CIED therapies based on their healthcare-related values, preferences, and goals. [Data suggest] that physicians are not necessarily comfortable with device deactivation—their understanding varies, and their comfort level varies as well.”

Some doctors believe that especially pacemaker withdrawal is tantamount to physician-assisted suicide or euthanasia.

There is a common misconception that such withdrawal is just like “pulling the plug” leading to instantaneous death. The guidance provides that doctors should carefully discuss and inform the patients and family members the consequences of cardiac device withdrawal.

Heart(y) News, May 21

Nintendo Wii gets the AHA thumbs-up
A video game gets the American Heart Association (AHA) heart check? Well, it is not just any video game. It’s the Nintendo Wii virtual exercise and active game systems. In return for the heart check, Nintendo is donation $1.5 million to AHA. Uh-uh. Has AHA sold out to the enemy? Well, it depends on how you look at it. According to AHA president Dr. Clyde Yancy:

“We can ignore the audience that is engaged with gaming—a huge audience—or we can find different ways of engaging that audience.”

AHA is giving Nintendo credit for pioneering physical active gaming also called “exergames.” The AHA heart logo, which will appear on the Nintendo Wii system, as well as video games Wii Fit and Wii Sports Resort, is part of a nationwide program to let consumers know that the organization considers the system and games healthy choices. Through this partnership, AHA aims to make exercise more fun and accessible.

A step to artificial life: Man-made DNA powers cell

Carl Venter of the Human Genome Project has made the headlines again. This time, he and his team claim to have created the first “synthetic cell”. Why synthetic? Because the cell is running on DNA synthesized in the lab. This is the first step in creating artificial life, an achievement which thrills some and scares others. The potential use of this development in health care is almost boundless.

New polypill trial begins in Europe; others planned
UMPIRE stands for Use of a Multidrug Pill in Reducing Cardiovascular Events, a clinical trial that just started in Europe. The trial compares compliance between the polypill (consisting of 75 mg aspirin, 40 simvastatin, and the antihypertensive agents, 50 mg atenolol and 10 mg lisinopril) vs individual medications. Other trials are being planned.

Statin side-effects found by British doctors
British researchers reported in the latest issue of the British Medical Journal about “unintended effects of statins” that include higher risk for kidney and liver problems as well as cataracts. However, the frequency of side effects seems to be low. To have a clearer view of the risk and benefits, let us take a look at the numbers. Of10,000 women with high-risk CVD profile treated with statin

• 271 cases of heart disease will be prevented..
• 8 cases of esophageal cancer will be prevented
• 74 patients will suffer from liver dysfunction.
• 23 patients will have acute renal failure.
• 307 will develop cataracts.
• 39 will develop muscular myopathy.

No Parkinson’s disease will be reported.

The authors write that their findings are “reassuring”.

“At national level, our study is likely to be useful for policy and planning purposes. Our study may also be useful for informing guidelines on the type and dose of statins.”

Cancer in the headlines, May 21

Swim Across America for cancer
Swim Across America will be hosting two events to benefit the Dana-Farber Cancer Institute. On July 16, 2010 is the Boston Harbor Island Swim. This 22-mile open-water relay features Olympians and local swimmers plunging into the Atlantic to make a difference for cancer survivors. This event kicks off with a party and silent auction and the swim starts at Rowe’s Wharf in Boston.

On July 17 is the Nantasket Swim. Swimmers age 12 and up are invited to join this fundraiser, which features a one-mile competitive swim and a half-mile recreational swim. Both events start at the Nantasket Beach House in Hull, Mass.

All proceeds support follow-up care and research for cancer survivors at Dana-Farber’s David B. Perini, Jr. Quality of Life Clinic.

Pink Ribbons on the Road: Texas Gets Breast Cancer License Plate
Starting this month, the state of Texas follows the example of other states and is offering specialty license plates with oink ribbons to help promote breast cancer awareness. Two different designs are available at $55 a year and 10% of the proceeds will be donated to National Breast Cancer Foundation. “The plates will be available for cars, motorcycles, trailers, RVs and buses. Personalization is also offered at an additional cost. The license plate will be available for pick up at the county tax assessor’s office about three weeks after the order is placed.”

Actress Lynn Redgrave Dies at 67 of Breast Cancer
Lynn Redgrave, actress and mother died of breast cancer earlier this month. According to her family, she “passed away peacefully after a seven year journey with breast cancer.”The 67-year old documented this journey in her autobiographical photographic journal “A Mother and Daughter’s Recovery from Breast Cancer”. After undergoing mastectomy and several types of therapies, Redgrave was declared cancer-free in 2003. However, the cancer came back and metastasized to other organs this year.

Cancer report energizes activists, not policy
What really causes cancer? Is it the carcinogens that are in the food and drinks we consume and in the air we breathe or is it our unhealthy lifestyle such as smoking and lack of physical activity? Experts are debating heated over this issue. A panel consisting of two cancer experts issued a report recommending drastic policy changes that would address the environmental causes of cancer. However, Dr. Graham Colditz of the Washington University School of Medicine in St. Louis believes the report only distracts people from behavioral changes that can prevent cancer by giving them other scapegoats to blame. More about the debate in the next post.

Heart(y) news, May 11

I have compiled some heart(y) news for you last weekend, which unfortunately, couldn’t be posted due to the hassles of intercontinnetal travel. Here they are now….

Almost half of US adults have diabetes, hypertension, or hypercholesterolemia
Almost 50% of the American population are suffering from at least 1 of the following chronic conditions: hypertension, hypercholesterolemia or diabetes. According to a report from the Centers for Disease Control and Prevention (CDC), 45% of individuals 20 years of age and older have hypercholesterolemia, hypertension, or diabetes. of these, 3% of adults had all three conditions and 13% had two conditions. hypertension and hypercholesterolemia were present in 9% of adults, and 3% of adults had high blood pressure and diabetes.

Court rejects Boston Scientific/Guidant plea deal
The US District Court in Minnesota did not accept the plea bargain deal between Boston Scientific and the US Department of Justice. The case involved Boston Scientific’s subsidiary Guidant and the failure of some of its implantable cardioverter defibrillators (ICDs) in 2005. According to heartwire, the plea agreement would have required Boston Scientific to pay a penalty of more than $296 million, which would be the largest criminal penalty ever imposed on a device manufacturer for violating the Food, Drug, and Cosmetic Act.

Obesity in America
These audiocasts from the U.S. Agency for Healthcare Research and Quality (AHRQ).news series Healthcare 411 cover topics from current US obesity rates and obesity-related healthcare costs as well as prevention and treatment.

New kid on the ARB block presented
Takeda Pharmaceuticals presented its  new angiotensin-receptor blocker (ARB) azilsartan medoxomil at the Society of Hypertension (ASH) 2010 Scientific Meeting in New York earlier this month. The ARB has been submitted for approval for the US market at the end of April.

According to Nancy Joseph-Ridge, M.D., general manager of Takeda’s Pharmaceutical Development Division:

“The NDA submission for azilsartan medoxomil is built upon a robust data package and is a significant milestone for Takeda. We are proud to build upon our global expertise in the cardiovascular therapeutic area with this filing, and believe this compound, once approved, will provide an important treatment option for hypertensive patients and the health care providers who manage them.”

Cleveland Clinic Health Chats for May

• May 11, 2010 Understanding Stroke Risk Factors, Symptoms and Treatment Options with James Gebel, MD
• May 19, 2010 Valve Surgery with A. Marc Gillinov, MD
• May 26. 2010 Pediatric Stroke: Treatment and Care with Neil Friedman, MBChB

Planes, trains, and automobiles (or, ISHLT vs the volcano)
Nature does not give allowances for naybody, including doctors and scientists. Which is why the orgnaizers International Society for Heart & Lung Transplantation Conference last April had to face the fact that the European delegates couldn’t make it to the Chicago venue. But with technology and creativity, Europeans were still able present and participate through satellite sessions. One delegate who was on an trip to the North Pole did not know that the homeward bound trip would be more troublesome than the expedition itself. Dr Heather Ross of Toronto General Hospital summarized her trip home, just in time for the conference

“In all, from leaving the Pole, it was six days, seven countries, two ferries, the bus ride, the car drive, and six or seven separate flight bookings that I was bumped from” plus many other back up reservations.

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