Heart(y) news, 28 January

January 28, 2011 by  
Filed under HEART AND STROKE

MEDICAL DEVICES

First bioabsorbable stent approved in Europe
Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) stent is the first bioabsorbable stent to be in the market. The stent manufactured by Abbott “utilizes a poly-L-lactide polymer and is indicated for the treatment of coronary artery disease.” Absorb has been approved for the European market.

Nearly a quarter of ICD implants are not recommended by professional guidelines
Implantable cardioverter defibrillators (ICDs) are mean to save lives and recommended by many clinical guidelines. Unfortunately, many ICD implant procedure do not meet guidelines specifications and were found to be increase risk for in-hospital complications.

HEART DRUGS

Merck stops vorapaxar in stroke patients, closes out TRACER trial
Trials testing the investigational cardiovascular drug vorapaxar has run into problems. The data and safety monitoring board (DSMB) had recommended that the drug should be contraindicated in subjects with a history of stroke due to potential increased risk in intracranial hemorrhage.

FDA Alert: Multaq (dronedarone) and Risk of Severe Liver
TFDA has issued a safety communication regarding the antiarrhythmic drug dronedarone (Multaq). The drug was linked to several cases of rare but severe liver problems, two of which necessitated liver transplantation. The manufacturer Sanofi-Aventis has informed health care professionals about the risk but claims that causal association has yet to be established. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) are has expressed a need to update product info on dronedarone as precautionary measure.

CCB/macrolide antibiotic combo ups risk of hypotension
Millions of people are using calcium-channel blockers (CCBs) for treatment of hypertension, angina and arrhythmia. Many of them may also be prescribed macrolide antibiotics for infections. However, these 2 classes of drugs which are effective and safe can cause toxicity when combined. The dangerous drug-drug interaction especially concerns the use of the antibiotics erythromycin or clarithromycin together with CCBs which can result in hypotension.

SHARING EXPERIENCE

Finally I got this through email:

Seeking patients to share their rehab experiences

The American Heart Association is working with international design consultancy IDEO (www.ideo.com) to design a better cardiac rehab experience for patients. We are interested in speaking to several patients in the Greater Boston area for in-home visits to talk about their rehab experiences, after an event such as a heart attack or heart procedure.

Visits would take place in the participant’s home, will be conducted by 2-3 IDEO designers and AHA employees, and will last 1.5 hours. Each participant will be compensated $150 for their time. If interested, please complete our online survey linked here. All responses will be kept confidential.

Heart(y) News, 12 Nov: the famous and the rich

November 12, 2010 by  
Filed under HEART AND STROKE

This Friday, we are bringing you some heart(y) news on celebrities…

Sudden death of Argentina’s past president six weeks poststenting prompts questions, fears
A well-known statesmen died from cardiac arrest following stenting, bringing up questions about the procedure. Néstor Kirchner was the president of Argentina from 2003 to 2007. He was also the husband current president, Cristina Fernández de Kirchner. He underwent stenting in September and received a drug-eluting stent. He suffered from a fatal cardiac arrest 6 weeks later. He was only 60 years old.

Kirchner’s narrowed carotid was detected during a carotid ultrasound screening in February, which prompted an increased demand among Argentineans for the procedure, indicating increased awareness of coronary heart disease. Unfortunately, his death may have also prompt increased fears.

First ladies join The Heart Truth to raise women’s heart disease awareness
Currently on display at The George Bush Presidential Library and Museum in Texas are the latest additions to the First Ladies Red Dress Collection as part of the Heart Truth campaign. Two ex-First Ladies, Laura and Barbara Bush officially opened the exhibition.

About the campaign: The Heart Truth is a national awareness campaign for women about heart disease and is sponsored by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, U.S. Department of Health and Human Services.

About the collection: The exhibit features red dresses and suits on loan from the presidential libraries and personal collections of 14 of America’s first ladies—including a Jacqueline Kennedy dress that was last displayed in 2003. Other featured dresses and suits include those worn by Lou Hoover, Eleanor Roosevelt, Bess Truman, Mamie Eisenhower, Lady Bird Johnson, Pat Nixon, Betty Ford, Rosalynn Carter, Nancy Reagan, Barbara Bush, Hillary Clinton, Laura Bush, and Michelle Obama.

Chilean miner wins NY hearts by finishing marathon
Edison Pena was not the fastest during the New York City Marathon last weekend but he was definitely a favourite among the crowd. He finished the run in 5 hours 40 minutes 51 seconds, more than 3 hours behind the winner but for the New Yorkers, he is a winner, too. Just a few weeks ago, Pena was trapped in a mine in Chile. During his several months underground, Pena kept fit by jogging through the tunnels of the mine – in his miner boots. A sad note is the dropping out of Haile Gebrselassie, running legend and marathon world record holder, due a knee injury.

Heart(y) news, Sept 3

September 4, 2010 by  
Filed under HEART AND STROKE

Let us look at the recent results from several cardiology clinical trials.

CURRENT-OASIS 7 published: Double-dose clopidogrel in PCI debated
CURRENT-OASIS stands for Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent Events/Optimal Antiplatelet Strategy for Interventions and is a randomized factorial trial that compared “double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes.” The study results which were recently published in 2 separate papers, one in the New England Journal of Medicine (NEJM) and the other in the Lancet showed.
“…no significant benefit of doubling the dose of clopidogrel for the first seven days in the overall population of [acute coronary syndrome] ACS patients referred for an invasive strategy but suggesting benefit in the patients who actually underwent [percutaneous coronary intervention] PCI.

KYOTO HEART analyses show benefit of valsartan in Japanese hypertensive patients
The KYOTO HEART study investigated the effects of the angiotensin-receptor blocker (ARB) valsartan as add-on therapy to conventional antihypertensive non-ARB treatment in Japanese patients. The results showed that the add-on therapy of valsartan reduced the risk of cardiovascular events that included “a composite of stroke; acute MI or angina; PCI or CABG; hospitalization due to heart failure, peripheral arterial disease, or aortic dissection; or transition to dialysis or doubling of creatinine levels.” However, no significant differences in blood pressure measurements suggesting that “the benefit is not derived from any antihypertensive effects.”

PACE: Dyssynchrony leads to lower ejection fraction in RVA-paced heart-failure patients
PACE stands for Pacing to Avoid Cardiac Enlargement (PACE). The study investigated whether “biventricular pacing is superior to right ventricular apical [RVA] pacing in preventing deterioration of left ventricular systolic function” in heart failure patients. The results showed that RVA pacing is linked to systolic dyssynchrony that reduces left ventricular function. Half of the patients who underwent RVA mode of pacing present with systolic dyssynchrony.

AVERROES: Apixaban yields significant reductions in stroke, no increased bleeding
AVERROES stands for Apixaban versus Acetylsalicylic Acid to Prevent Strokes and is one of the few trials which were stopped early because of positive results. The results from the trail indicate that apixaban, an oral factor Xa inhibitor still in the clinical trial stage, seems to be more effective than aspirin in lowering the risk for stroke and systemic embolic events. In addition, apixaban seems to have a better safety profile, “with no observed increases in the risk of major bleeding, minor bleeding, or intracranial hemorrhage.” AVERROES was stopped early because a prespecified interim analysis showed significant benefits with apixaban. A repeat trial confirmed the benefits.
According to lead investigator Dr Stuart Connolly of McMaster University, Hamilton, Ontario (source heartwire):

It’s a very easy to use drug to give. You take it twice a day, and it’s well tolerated. It didn’t have any liver toxicity, no particular adverse events that we saw. If anything, it’s extremely safe. We consider aspirin to be a drug we can just about give any patient, but aspirin does cause bleeding. It’s not completely benign.”

Health care updates, Sept 3

September 3, 2010 by  
Filed under HEALTHCARE

Botox maker to pay $600M to resolve federal investigation
Botox maker Allergan will pay $600 million to resolve an ongoing federal investigation on “misbranding” misdemeanour. Allergan supposedly wrongly marketed Botox off-label. Botox is approved for smoothing facial wrinkles, treat neck elbows, wrists and fingers spasms, eye muscle disorders and excessive underarm sweating. Off-label use includes headache, pain, spasticity and cerebral palsy.

Superfast TB test slashes waiting time
Tuberculosis test results ready in 90 minutes? That is indeed a big improvement over the current standard smear test that takes 6 weeks to complete. What’s more, the Xpert MTB/RIF test can identify 98% of active TB cases and detect those which are resistant to the TB drug rifampicin. The smear test has a sensitivity of only 45%. The test would be a big boost to the ongoing anti-TB campaign in developing countries where prevalence of the disease is high. However, barriers to the test’s widespread use still need to be overcome, e.g. its feasibility to use in ill-equipped labs and its price.

483 Inspectional Observations on the Egg Recall
The US FDA is continuing investigations into the shell eggs recall due Salmonella contamination involving  2 Iowa-based farms Wright County and Hillandale Farm. On the FDA site could be found some results from the inspections (“483 inspectional observations”) for listing some problems observed, including manure tracking and leakage, several points of ingress for rodents and other vermin into the hen houses, and other structural and sanitation problems, indicating non-compliance to required biosecurity measures.

Private-Party Gun Sales, Regulation, and Public Safety 
In the August review of the New England Journal of Medicine, researchers wrote a perspective article on the unregulated sale of firearms at “private parties”.

“…private parties can buy and sell many guns a year while claiming not to be engaged in the business. Perhaps 40% of all gun sales nationwide — roughly 6.6 million transactions in 2008 — are made by private parties. Moreover, private parties can sell handguns to anyone 18 years of age or older; licensed retailers cannot sell handguns to anyone under 21 years of age.”

Topless nurse advert gets pulses racing in Denmark
The Danish are known for their rather sexy shows and ads. But this one coming from no other than the Danish Nurses’ Organisation was deemed a bit too “racy.” The recruitment drive ad showed a topless nurse rubbing her breasts on the head of a flatliner male patient to revive him. The association, in trying to augment the shortage of nursing staff in the country, tries to change the image of the nursing profession from being such a drudge to being sexy. However, negative response to the ad forced the nursing group to pull out the ad.

Heart(y) News, August 20

August 20, 2010 by  
Filed under HEART AND STROKE

Mipomersen passes hurdle in two trials
The new and upcoming anti-cholesterol drug mipomersen performed quite well in two phase 3 trials. Mipomersen is an antisense inhibitor of apolipoprotein B (apoB) synthesis and was shown to be able to lower LDL-cholesterol significantly compared to placebo (36 vs 13%). The trials demonstrated a good efficacy profile but drop out rates were rather partly because of adverse events that include elevations in liver enzymes. The manufacturer Isis Pharmaceuticals is expected to apply for drug approval next year.

Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
The drug midodrine hydrochloride (ProAmatine), on the other hand, is under threat of being withdrawn from the US market. ProAmatine, which is indicated for low blood pressure was approved by the FDA in 1996 under the accelerated approval system which require postmarketing studies to verify efficacy and safety. However, no studies have been performed. Shire, the drug maker currently holding patent to the drug declared “it had already intended to voluntarily withdraw the drug, long before the FDA went public with the proposal.” Shire acquired ProAmatine when they took over Roberts Pharma in 1999. The drug is also manufactured by other companies in generic form. The withdrawal will take effect on September 30, 2010. The FDA recommends: Patients who currently take this medication should not stop taking it and should consult their health care professional about other treatment options.

NIH Genomic Mapping Study Finds Largest Set of Genes Related to Major Risk Factor for Heart Disease
National Institutes of Health researchers report they have identified largest set of genes underlying high cholesterol and high triglycerides. This major feat was made possible by scanning the genomes of over 100,000 worldwide. The research team consisted of scientists from 17 countries. According to study co-author and NIH Director Dr. Francis S. Collins
“Genetic studies that survey a wide variety of human populations are a powerful tool for identifying hereditary factors in health and disease. These results help refine our course for preventing and treating heart disease, a health problem that affects millions of Americans and many more people worldwide.”

Telemonitoring of HF patients reduces deaths, costs
Australian researchers report success of a telemonitoring and structured telephone support program to reduce “risk of all-cause mortality and heart-failure-related hospitalizations.” Particularly interesting is the fact that most participants were quick in learning the use of the technology.
“Structured telephone support and telemonitoring reduced healthcare costs, were acceptable to patients, improved prescribing of evidence-based pharmacotherapies, improved patient heart-failure knowledge and self-care behaviors, and even improved NYHA functional class in those studies that assessed it.”

Heart(y) news, July 30

July 30, 2010 by  
Filed under HEART AND STROKE

Trans fat use “close to zero” in fast-food chains
Sounds too good to be true but American fast food chains seem to be making progress in getting rid of transfat from their menus, especially the notoriously fatty fries. Burger King, Wendy’s, Jack in the Box, and Dairy Queen  – the top five reportedly managed to reach the “almost zero” level of transfat in their products without increasing saturated fats in the process. The results of the study were presented last week at the 2010 National Nutrient Database Conference in Grand Forks, ND. This is based on data collected by the University of Minnesota’s nutrition coordinating center, which tracks the nutritional value of more than 18,000 food.

The antitrans fat movement goes back just a few years but seems to be making lots of progress. Heartwire reports:

In New York City, where a two-phase ban on trans-fatty acids was instituted in 2007, as reported previously by heartwire, the use of the partially hydrogenated vegetable oil declined to less than 2%, a recent study showed. The use of trans fat is banned in California, and other cities and states have partial or full bans in place. Denmark was the first country to introduce laws regulating the sale of food with trans-fatty acids. The UK Faculty of Public Health and the Royal Society for Public Health have called for the elimination of trans fat in the UK by 2011.”

Two new randomized trials bolster benefits of compression-only CPR
Cardiopulmonary resuscitation (CPR): with or without mouth-to-mouth ventilation? New data from two trials seem to answer the question. Compression-only CPR is just as good as or maybe even better than CPR with both compressions and mouth-to-mouth ventilations. In recent years, experts campaigned for the so-called hands-only CPR which is supposedly easier and more acceptable and encourages bystander CPR.

“Overall, this [nationwide] study lends further support to the hypothesis that compression-only CPR, which is easier to learn and to perform, should be considered the preferred method for CPR performed by bystanders in patients with cardiac arrest,”

AHA Scientific Statement
Earlier this month, the American Heart Association (AHA) issued this scientific statement: “Combined behavioral interventions are the best way to reduce heart disease risk.” This is an indirect way of saying that medications alone are not enough. According to an AHA press release:

“Combining counseling, extended follow-up with a healthcare provider and self-monitoring of diet and exercise is the most effective way to help patients embrace lifestyle changes that can lower their risk for heart and blood vessel (cardiovascular) diseases.”

Health care updates, July 30

July 30, 2010 by  
Filed under HEALTHCARE

Prestigious US journal gets a new web site
The New England Journal of Medicine, one of the most prestigious journals in the world, has a new site with better accessibility, more interactivity, and better search engine to help doctors deliver quality health care. Check out the new www.NEJM.org.

The Path to Personalized Medicine
This perspective article published in NEJM was authored by 2 health care experts, Dr. Margaret A. Hamburg, commissioner of the US FDA and Dr. Francis S. Collins, director of the National Institutes of Health (NIH). The article discusses the pathway to personalized medicine and how basic, translational, and regulatory science work hand in hand towards this goal. The authors wrote:

“… the NIH and the FDA will develop a more integrated pathway that connects all the steps between the identification of a potential therapeutic target by academic researchers and the approval of a therapy for clinical use. This pathway will include NIH-supported centers where researchers can screen thousands of chemicals to find potential drug candidates, as well as public–private partnerships to help move candidate compounds into commercial development…”

U.S. experts back AstraZeneca blood thinner
Good news for AstraZeneca. A US FDA panel recommends the approval of Brilinta, the company’s new blood-thinning agent that supposedly can help prevent deaths and heart attacks. This is welcome news to AstraZeneca as the company faces lawsuits as well as expiration of the patents of their bestselling drugs.

The panel vote was a welcome surprise as data from US clinical trials were initially not so convincing compared to its competitors. Although final approval hasn’t been announced yet, experts believe the US FDA will follow the panel’s recommendations.

Inequalities in mortality in Britain today greater than those during 1930s economic depression
How can this be true? Disparities in premature mortality among the British population are worse than ever. Worse, in fact, than what was reported during the great depression in the 1930s. This is according to a study by researchers at the University of Bristol and the University of Sheffield. The researchers believe the inequalities are due to the widening gap in wealth and income. The authors report:

Although life expectancy for all people is increasing, the gap between the best and worst districts is continuing to increase. The economic crash of 2008 might precede even greater inequalities in mortality between areas in Britain.”

Cancer in the headlines, July 23

July 23, 2010 by  
Filed under CANCER

Mom searches China for donor to save her daughter’s life
Fifteen years ago, Sherrie Cramer adopted a malnourished baby from a Chinese orphanage who grew up to be Katie. Four years ago, the now 16-year old Katie developed leukemia and needed a bone marrow transplant. Unfortunately, no match in the US can be found. Katie’s situation highlights a common problem facing ethnic minorities in the US. “The Asian American Donor Program says ethnic minorities overall have a 50 percent chance of finding a perfect match from the U.S. bone marrow donor registry of 8 million people, compared to an 80 percent chance for Caucasians.”

Annual report: US cancer death rates still declining
Death rates due to cancer are continuing to decline, according to Cancer Statistics, 2010, the annual cancer statistics report of the American Cancer Society’s (ACS). According to Dr. John R. Seffrin, chief executive officer of the American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN):

“This report is yet more proof we are creating a world with more birthdays… We will build on our progress in the fight against cancer through laws and policies that increase access to cancer prevention, early detection, and treatment services, and with a sustained federal investment in research designed to find breakthroughs in the prevention and treatment of the most deadly forms of cancer.”

Yet, the battle is far from over. There is still much work to be done and cancer continues to be a major health concern in the US.

The report is accoumpanied by Cancer Facts & Figures 2010 and is published in the ACS journal CA: A Cancer Journal for Clinicians.

FDA advisory panel votes against Avastin for advanced breast cancer
A US FDA advisory panel voted to withdraw the approval of the cancer drug bevacizumab (Avastin) for the indication of advanced breast cancer in combination with chemotherapy. New data from clinical trials indicate that Avastin does not seem to provide added benefit compared to treatment with chemo alone. Avastin is approved for other types of cancer as well and the panel’s recommendation does not apply to the other approved indications.

NY mulls indoor tanning rules, cites cancer risk
New York is on the move again in trying to improve its residents’ health. Next to smoking bans and the trans-fat free restaurant food, it is now looking into tanning salons. Current New York law bans “commercial indoor tanning for children under 14 and requires written parental consent for those from 14 up to 18.” Health advocates are pushing for stricter regulations, calling tanning beds “cancer chambers.”

Heart(y) news, July 16

July 16, 2010 by  
Filed under HEART AND STROKE

Wii Games summer 2010
The American Heart Association (AHA) is participating in Wii Games 2010. Earlier this year, AHA announced its collaboration with Nintendo in order to promote active play. The Wii Games is a US-wide tournament that everybody – adults and kids alike – can participate in.

American Heart Association site gets a new look
Have you noticed that the American Heart Association (AHA) site has changed? I can’t tell you exactly when it happened but it looks cool. Check it out at www.heart.org.

Diabetics Urged to Confer With Their Doctor About Avandia Use
The recommendations of the FDA advisory panel Avandia (rosiglitazone) are out. The anti-diabetic drug Avandia may stay on the market – but with additional restrictions, the panel says. Some critics think the panel gives a “mixed message” and a “muddled answer” to the FDA and to the medical community, according to heartwire. The panel assessed the safety of Avandia in terms of increasing risk for heart disease.

Despite being able to stay on the market, experts are predicting that many healthcare providers will advise their patients to change to safer medications.

According to Dr. Jacob Warman, chief of endocrinology at The Brooklyn Hospital Center in New York City:

“Why give a drug with restrictions when a similar drug which has studies that did not show the bad outcomes of Avandia could be used instead.. I don’t see anybody willing to take Avandia when they could take Actos.”

Conflicted FDA committee votes against recommending approval of weight-loss drug Qnexa
Another drug reviewed was a new anti-obesity drug which  a combination of phentermine and controlled-release topiramate . Unlike Avandia, this new drug Qnexa has less luck. The committee did not recommend its approval. In particular, the committee was concerned about the drug’s safety because of a long list of side effects that include “depression; anxiety; sleep disorders; attention, memory, language, and other cognitive disorders; metabolic acidosis; increased heart rate; and teratogenicity.”

FDA to look into possible cancer risk with ARBs
After the European Medicines Agency (EMEA) announced its intention to investigate the cancer risk associated with angiotensin receptor blockers (ARBs), the US FDA followed suit. According to an FDA safety alert, it has “not concluded that ARBs increase the risk of cancer. The agency is reviewing information related to this safety concern and will update the public when additional information is available. FDA believes the benefits of ARBs continue to outweigh their potential risks.”

The most commonly used ARBs on the market are Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.

Cancer in the headlines, July 9

July 9, 2010 by  
Filed under CANCER

Get Cancer Information from CDC on Twitter!
The Division of Cancer Prevention and Control of the CDC has launched a new profile on Twitter to promote effective, science-based strategies to prevent and control cancer. CDC_Cancer gives credible cancer information from CDC. Sign in now!

Lung Cancer in Women on the Rise
Lung cancer is decreasing in men but increasing in women, even in non-smoking women. And the problem may lie in the estrogen. Mortality projections for 2010 are 71,000 for women and 86,000 for me. Lung cancer deaths in women are now much higher than those caused by cancer. More about these next week.

US senator urges release of sunscreen chemical data
US Senator Charles Schumer is calling for the release of data linking certain sunscreen ingredients to skin cancer. The US FDA has been reviewing data regarding the safety of retinyl palmitate, a vitamin A derivative. The data and the results haven’t been released yet. According to the Senator:

“With the recent reports suggesting a possible link between skin cancer and a common chemical found in sunscreens, the FDA must act now to protect consumers.”

Cancer deaths to double by 2030, report says
Cancer rate is on the rise and deaths due to cancer will double by the year 2030, according to International Agency for Research on Cancer (IARC) estimates. In 2008, cancer mortality was 7.6 million. In 2030, it will be around 13.2 million. Cancer is not restricted to developed countries alone. 63% of all cancer deaths in 2008 were reported in underdeveloped countries.

ESMO publishes updated guidelines on cancer care
The European Society for Medical Oncology (ESMO) has just issued a revised and enhanced version of clinical recommendations on cancer care. The new guidelines offer “vital, evidence-based information including the incidence of the malignancy, diagnostic criteria, staging of disease and risk assessment, treatment plans and follow-up.”

Counselling Increased Mammography Use Among Low-income Women with Health Insurance
Concern over health costs is one of the major barriers to prevention. Mammography rates are low among women of low income, even if they have health insurance coverage. Researchers at the Robert Stempel College of Public Health and Social Work at Florida International University, however, found that a special counselling program can improve screening rates. A personal counselling is especially more effective, with an increase of 27.1% although counselling through sending a letter also affected an increase of 16.1%. Prior to counselling, the screening rate was only at 13.4%.

Health care updates, July 2

July 2, 2010 by  
Filed under HEALTHCARE

Surgeon General Urges Exercise for Optimal Health
The US Surgeon General Regina Benjamin released a paper The Surgeon General’s Vision for a Healthy and Fit Nation [2010] earlier this year with exercise as the main theme. The surgeon general states:

“…I am asking healthcare organizations across this country to join the Exercise is Medicine initiative. Exercise is Medicine is a multinational, multiorganizational initiative. It brings physical activity to the forefront of disease prevention and treatment, by making exercise a part of every patient’s interaction with a health clinician. Exercise is Medicine strives to provide the essential connection between clinicians, fitness professionals, and the public, so that everyone can receive the guidance they need to stay healthy and active. All the partners in this initiative are dedicated to the idea that exercise is the new medicine.”

Healthcare 411 – Leaving the Hospital
The US Agency for Healthcare Research and Quality (AHRQ) has developed a guide for patients leaving the hospital to help them with follow-up care and recovery at home. The guide is called Taking Care of Myself: A Guide for When I Leave the Hospital and covers the following issues:

FDA Marks First Anniversary of Tobacco Control Act
The Family Smoking Prevention and Tobacco Control Act was signed by US President Barck Obama on June 21, 2009, giving the U.S. Food and Drug Administration (FDA) authority over tobacco products. During the past 12 months, the FDA initiated a lot of changes and new regulations that address sale, distribution, marketing, advertising and packaging of cigarettes and other tobacco products. More changes are expected in the coming year.

HHS Launches New Consumer Focused Health Care Website www.HealthCare.gov
The US Department of Health and Human Services (HHS) launched a new on-line tool that will help consumers and patients understand the health care reform and how this could affect them. In particular, the website HealthCare.gov will help them access, affordable health care coverage.

“HealthCare.gov  helps consumers take control of their health care and make the choices that are right for them, by putting the power of information at their fingertips,” said HHS Secretary Kathleen Sebelius.  “For too long, the insurance market has been confusing and hard to navigate.  HealthCare.gov makes it easy for consumers and small businesses to compare health insurance plans in both the public and the private sector and find other important health care information.”

Cancer in the headlines, May 14

May 14, 2010 by  
Filed under CANCER

Here are some news updates on cancer treatments for you this weekend.

New bone marrow transplant method eases risk
A new method of bone marrow transplant lowers the risk for infection. The traditional transplantation method destroys the recipient’s bone marrow by high dose radiation or chemotherapy before infusion of the donated bone marrow. The time between the destruction and the replacement bone marrow starts to function is a time when the immune system is compromised and the patient is highly susceptible to infection. The new method does not completely destroy the original bone marrow but just tamps it down to give space for the donated marrow. Thus, the immune system is not compromised and the patient and donor bone marrow co-exist together, the so-called “mixed-cell chimerism”.

Approval of prostate cancer immunotherapy marks milestone in new era of cancer treatments
Last month, the US FDA approved Provenge®, a new form of therapeutic vaccine for prostate cancer patients. Provenge is an autologous cellular immunotherapy and unlike preventive vaccines, marshals the immune system’s disease-fighting forces for people who already have prostate cancer.
“The immunotherapy is produced by removing some of a patient’s white blood cells — a process called leukapheresis — and then exposing them to a protein from prostate cancer cells and a stimulatory molecule. The process primes the white blood cells to stimulate the immune system and attack prostate cancer when they are re-injected into the body.

Clinical trials data show that Provenge prolongs survival and reduce overall risk of death.

Can Celebrex prevent cancer-causing colon polyps?
Celebrix (celecoxib) is being tested for its ability to prevent the development of colon polyps that may be precursors to colon cancer. The test is being done at Rush University Medical Center. Celecoxib is an anti-inflammatory drug originally indicated for the treatment of arthritis. It has already been approved by the US FDA for prevent of polyp formation in the rectum.

New hope for better treatment for a rising cancer
The Nottingham Gastro-Oesophageal Cancer Research Group is engaged in research on a rapidly rising cancer that might soon become an epidemic – oesophageal and upper stomach cancer. The group’s research, using molecular and DNA protein expression techniques that only 40 to 50% of tumors of this disease repond to chemotherapy. A monitoring test has been developed to help doctors evaluate which tumors are responsive. The researchers have also identified a promising protein marker involved in DNA repair in cancer cells that predicts resistance of tumors  to chemotherapy.

According to Dr Srinivasan Madhusudan, Clinical Associate Professor & Consultant in Medical Oncology at Nottingham University Hospitals and the University’s School of Molecular Medical Sciences

“Recent scientific advances have given real hope for patients with gastro-oesophageal cancers. The Nottingham Upper Gastrointestinal Cancer Group is a multidisciplinary research team consisting of Oncologists, Surgeons, Pathologists and Radiologists. We aim to exploit the ‘new science’ for patient benefit. This study published online today in the British Journal of Cancer provides evidence that it may be possible to tailor gastro-oesophageal cancer treatments based on ‘new’ biology. We are planning a larger prospective multicentre study to confirm these findings and we believe will have major clinical impact on how we treat these aggressive tumours in the future.”

Heart(y) News, April 16

April 16, 2010 by  
Filed under HEART AND STROKE

Approval, phase out and drug-drug interactions. These are the updates we are bringing you today.

FDA Approves First Biodegradable Sealant Patch for Cardiovascular Surgery
TachoSil is the first absorbable fibrin sealant patch for use in cardiovascular surgery and was approved by the US FDA earlier this month. TachoSil is indicated to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or not feasible. TachoSil is made of dry collagen sponge from horse tendons, and coated with fibrinogen and thrombin from strictly screened blood donors.  Fibrinogen and thrombin reacts in the wound to produce fibrin which facilitates blood clotting. The patch breaks down and is absorbed into the body within four to six months.

Asthma and COPD Inhalers That Contain Ozone-depleting CFCs to be Phased Out; Alternative Treatments Available
You may not be ware of it, but your inhaler might also contain chlorofluorocarbons (CFCs) that deplete the ozone layer. The US FDA has recently announced the gradual phasing out of these inhalers from the US market. The phase out will especially affect seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD). The phase out is in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer. However, alternative medications that do not contain CFCs are available.

Cotrimoxazole ups bleeding risk in warfarin patients
Cotrimoxazole is an antibiotic commonly prescribed for urinary tract infections (UTI). However, it seems that can interact with warfarin to increase the risk for bleeding, according to a study by researchers at the University of Toronto. Warfarin is an anticoagulation commonly prescribed for patients with cardiovascular disease (CVD) to prevent heart attack and stroke. Since UTI and CVD can co-occur especially in elderly patients, doctors are advised to use alternative antibiotics when treating UTI in patients taking warfarin to avoid hemorrhage.

Still no answers in largest review on clopidogrel/PPIs
On the other hand, the possible interaction between the antiplatelet agent clopidogrel and proton-pump inhibitors (PPIs) is still not clear, according to a meta-analysis by researchers at the University of East Anglia, Norfolk, UK. According to German cardiologist Dr Dirk Sibbing of German Heart Center in Munich (he was not part of the study):

From a pharmacological point of view, this interaction is real, no doubt about that. From a clinical point of view, it’s still a matter of debate. The clue might be found in specific subgroups of patients. For some selected subgroups, coadministered PPIs may be harmful; for the majority of patients, however, this may not be the case.”

Heart(y) News, April 9

April 9, 2010 by  
Filed under HEART AND STROKE

The US National Start! Walking Day started this week on Wednesday, April 7. Starting is easy: what about taking a 30-minute walk around your workplace? What about taking the stairs rather than the lift? We will bring some more details about Start! Walking Day next week. In the meantime, take note that you can start anytime, anywhere. Make each day a walking day!

World Heath Day Statement by Secretary of Health and Human Services Kathleen Sebelius
Secretary Sebelius issued a statement supporting the World Health Day initiative and the World Health Organization. According to Sebelius, the 2010 theme “Urbanization and Health: Urban Health Matters” also applies to the US where 80% of the population lives in cities.

FDA Approves First Generic Versions of Two Drugs for the Treatment of Hypertension
Two popular anti-hypertension drugs are now available as generics. A generic form of Cozaar (losartan) has just been approved by the US FDA. A generic oral tablet containing losartan plus hydrochlorothiazide (marketed as Hyzaar) has also been approved. The safety warnings are applicable to the generic versions, including a boxed warning for pregnant women.

04-07-2010 – Radio Series – Comparing Blood Pressure Medicines
In an audio cast, the U.S. Agency for Healthcare Research and Quality (AHRQ) gives consumers information about the benefits, safety, and costs of anti-hypertension drugs. AHRQ Head Dr. Carolyn Clancy explains how an AHRQ describes two types of blood pressure pills:
Two common medicines, ACE inhibitors and ARBs, work by relaxing the blood vessels, which lowers blood pressure. Finding the right drug for you depends on balancing the benefits, side effects and costs. AHRQ’s guide has this type of information. So it can help you clarify your choices. Then you and your doctor can decide which treatment is best for you.

The guide “Comparing Two Kinds of Blood Pressure Pills” is available online at effectivehealthcare.ahrq.gov

Caution on Zyprexa for Adolescents
Zyprexa (olanzapine) is a medication used for the management of schizophrenia and bipolar disorder. Zyprexa is approved only for patients at least 13 years of age. The US FDA, however issued a warning about certain side effects of the drug in adolescents older than 13. These patients have a higher likelihood to gain more weight and experience sedation than adults and have greater increases in total cholesterol, LDL cholesterol, triglycerides, prolactin, and hepatic transaminase levels.

Healthy Soul Food Recipes (PTES 2010)
The 2010 Healthy Soul Food Recipes magazine cookbook recommended by the American Heart Association will soon be hitting the shelves. A couple of sample recipes are available at the AHA website.

Cancer in the headlines, March 19: clinical trials and screening updates

March 19, 2010 by  
Filed under CANCER

TWO BIG CANCER TRIALS FAIL

Trial # 1:
Avastin, Roche’s bestselling cancer drug failed to meet primary endpoints in a key Phase III prostate cancer trial. Roche’s daughter company Genentech announced the trial results showed that Avastin does not extend survival in patients with late stage prostate cancer. Just last month, the industry was also disappointed with Avastin’s poor performance in  a trial on inoperable or advanced stomach cancer. Avastin is approved for the treatment of colorectal, breast, lung and kidney cancer and a type of brain tumor.

Trial # 2:
Pfizer’s Sutent failed to meet endpoints in two Phase III trials on late-stage breast cancer. Sutent (sunitinib) is indicated for metastatic renal cell carcinoma and gastrointestinal stromal tumor. The company will continue testing Sutent on other solid tumors.

THE LATEST UPDATES ON CANCER SCREENING

1 in 4 states cut back on routine mammograms
The new US breast cancer screening guidelines have started to make an effect. Some states have already started cutting back on routine mammograms for women under 50 and uninsured. Proponents of the guidelines might be pleased but some groups are concerned about this trend.

According to Dr. James Thrall, chair of the American College of Radiology’s Board of Chancellors:

“Lawmakers at all levels need to act now to ensure that these recommendations do no further damage, and that women have full and ready access to mammography.”

Panel Calls for Reducing Colorectal Cancer Deaths by Striking Down Barriers to Screening
A National Institutes of Health panel met in February to discuss how to increase the use of colorectal screening. A 2008 survey showed that the screening rate among 50-year old adults is 55%, which experts consider to be too low.

According to Dr. Donald Steinwachs, panel chair, and professor and director of the Health Services Research and Development Center at the Johns Hopkins University

“We recognize that some may find colorectal cancer screening tests to be unpleasant and time-consuming. However, we also know that recommended screening strategies reduce colorectal cancer deaths. We need to find ways to encourage more people to get these important tests.”

Harry Smith colonoscopy to air on ‘Early Show’
The co-anchor of “The Early Show” Harry Smith had a colonoscopy scheduled on Wednesday, March 10 and the procedure was shown live in observance of the National Colorectal Cancer Awareness month.

Cancer society stops urging docs to offer PSA test
The American Cancer Society (ACS) has not supported routine PSA screening for prostate cancer since the 1990s and its stand remains the same. However, it is urging doctors to discuss the pros and cons of the procedure openly with their patients. ACS recommends the following to primary care physicians:

Cancer in the headlines, March 5

March 5, 2010 by  
Filed under CANCER

March is National Colorectal Cancer Awareness Month in the US

Information on Life after Cancer Now Available on NIHSeniorHealth.gov
Life after Cancer is the newest addition to the NIHSenior Health resource center of the National Institutes of Health (NIH). NIHSeniorHealth is a health and wellness site focusing on the needs of older adults. It was developed by the National Institute on Aging (NIA) and the National Library of Medicine (NLM), both part of the NIH. Life after Cancer addresses the needs of the elderly cancer survivors which make up almost 60% of all cancer survivors. Topics include follow-up care, physical and emotional changes, age-related complications, and relationships with family and friends

Researchers chart genomic map spanning over two dozen cancers
This is the largest study of its kind – mapping the genomes of 26 different cancers. The groundbreaking study started in 2004 by a group of international scientists led by researchers at Dana-Farber and the Broad Institute. The cancers studied some of the most common, e.g. lung, prostate, breast, ovarian, colon, esophageal, liver, brain, and blood cancers. Over 2,500 cancer specimens were collected and analyzed using chip technology. The analysis focused on a particular type of genetic abnormalities called somatic copy-number alterations or SCNAs present in many tumor types. According to senior author Matthew Meyerson:

“Our findings show that many genome alterations are universal across different cancers. Although this has been known for some types of changes, the degree to which so many alterations are shared was pretty surprising to us.”

Costly Tests May Not Help Detect Bladder Cancer Recurrence, M. D. Anderson Study Finds
Are these some of those costly but unreliable cancer screening tests? Cystoscopy is currently in gold standard in screening for recurrence of early-stage bladder cancer. Researchers at The University of Texas M. D. Anderson Cancer Center report that this is a cost-effective technique in detecting bladder tumors. However, some doctors tend to do additional tests such as testing for ancillary urinary markers. These tests, however, said the researchers, will simply increase costs without real benefits to the diagnosis. In fact, these tests could actually increase the rate of false positives that would cause distress and unnecessary procedures. According to senior research Dr. Ashish Kamat:

“The tests frequently added to cystoscopy have many more false positives than commonly believed, and they can lead to unnecessary work-ups. Our findings also may help reduce the cost of caring for bladder cancer patients, which currently in is the range of $4 billion annually.”

Online Health Chats at the Cleveland Clinic

Heart(y) News, February 19

February 19, 2010 by  
Filed under HEART AND STROKE

Texas Children’s discharges history-making patient
Sixteen-year-old Francesco “Frank” De Santiago is finally going home from the hospital, thus making history. He was the first pediatric patient to be discharged last October after receiving an implanted mechanical heart pump, or ventricular assist device (VAD). The VAD is a bridging device implanted in patients waiting for a heart donor. Other pediatric patients with VAD have to stay at the hospital until a matching heart donor is found. Frank finally received a donor heart on January 29 after a 9-nine operation

According to Dr. David L.D. Morales, pediatric cardiovascular surgeon at Texas Children’s Heart Center who implanted Frank’s device last May and performed his recent heart transplant.
“Frank’s surgery went extremely well; he was a much better candidate for a heart transplant now than eight months ago when his heart was failing. The device improved his physical health and allowed him be discharged so he could enjoy some normal teen activity during the wait for a donor heart. Texas Children’s is leading the way in using five different types of VAD technology to help pediatric patients enhance their quality of life and outlook so they are better prepared for their transplant surgery.”

Statement of Health and Human Services Secretary Kathleen Sebelius on American Heart Month, February 2010
The American Heart Month is soon coming to an end but the we hope that the lessons learned have long-lasting effects. Here is part of HHS Secretary Kathleen Sebelius’ statement:
American Heart Month is a time to spread awareness of the dangers of heart disease and stroke, and recommit to strengthening prevention, improving treatments, and helping all Americans live longer, healthier lives… This American Heart Month, talk with your doctor about your personal risk for heart disease and the steps to take to lower it.  By encouraging all Americans to adopt a healthy lifestyle, we can reduce the threat of heart disease and become a healthier country.”

NHLBI Funds Preclinical Tests on Devices for Infants and Children with Congenital Heart Defects
Each year, about 1,800 infants in the US die due to congenital heart defects. Many others suffer from heart diseases including heart failure. The US National Heart, Lung, and Blood Institute (NHLBI) has recently awarded four contracts totaling $23.6 million for preclinical testing of devices to help children born with congenital heart defects The program is called Pumps for Kids, Infants, and Neonates (PumpKIN) and is planned for 4 years. The contractors are researchers in University of Pittsburgh, Ension, Inc., University of Maryland, and Jarvik Heart, Inc.

According paediatrician Dr. Susan B. Shurin, NHLBI Acting Director

“This research seeks to develop technologies to expand life-saving options for infants and children born with congenital heart defects or those who develop heart failure. The NHLBI is committed to saving the lives of our youngest patients. Well-designed circulatory support devices are expected to substantially improve the outcomes of the infants and young children who need them as they seek to recover or wait to receive a heart transplant.”

Cancer in the headlines, Feb 19

February 19, 2010 by  
Filed under CANCER

FDA Cancer Drug Approval Rate Highlighted in JNCI
A review in the Journal of the National Cancer Institute gives positive feedback on US FDA’s rate of cancer drug approval. Between July 2005 and end of 2007, the regulatory body Office of Oncology Drug Products approved more than 50 new indications in oncology as well as hematology drugs and biologics. In addition, the review reports:

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
One of the latest approved cancer drug is Rituxan (rituximab), indicated for the treatment of chronic lymphocytic leukemia (CLL). CLL is a slowly progressing cancer of the blood and bone marrow primarily affecting people older than 50. It arises from a group of white blood cells known as B-cells—part of the body’s immune system. About 16,000 people in the US are diagnosed with CLL each year, resulting in 4,400 deaths. Rituxan is indicated for patients for chemotherapy-naive as well as chemotherapy-experienced patients not responding to ongoing therapy. Rituxan is administered in combination with two other chemotherapy drugs, fludarabine and cyclophosphamide.

According to Dr. Richard Pazdur, director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research

“Rituxan is the third drug approved for the treatment of CLL since 2008 and underscores FDA’s commitment to expediting the development and approval of drugs for patients with serious and life-threatening diseases.”

Merck: Studies boost Gardasil for new uses
The HPV vaccine Gardasil is effective against other conditions, according to its manufacturer Merck. Gardasil was initially approved for prevention of cervical cancer in females from age 9 to 26. Last year, it was approved for the prevention of genital warts in males aged 9 to 26. New studies indicate that the vaccine is also effective in preventing cervical cancer and genital warts in older women (up to 45 years) and anal cancer in men. Merck is applying for approval for these new indications.

Wishing you all a relaxing weekend!

What’s new in pain management

February 17, 2010 by  
Filed under HEALTHCARE

Many of us have to face pain every day, from mild headaches, to debilitating pain of chronic diseases. Today I bring you some news update in pain management.

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
The US FDA approved last month an oral form of morphine for the management of moderate to severe, acute and chronic pain in patients who are opioid-tolerant.  This pain management strategy has already been commonly used in the past even prior to the approval. In order to minimize the risk for abuse, misuse, and overdose, the US FDA decided to work the manufacturers, patient organizations and prescribers to better regulate the product and ensure its quality, as part of the so-called unapproved drugs initiative.
“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” said Douglas Throckmorton, M.D., deputy director for the FDA’s Center for Drug Evaluation and Research. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”

Botulinum toxin injection may help prevent some types of migraine pain
Botox is not just for taking the wrinkles away. It may also be able to ease the headaches away, according to researchers. A study reports that the botulinum toxin is associated with reduced frequency of migraines, the kind called ocular headaches, described as “crushing, vice like or eye-popping” pain.
“These preliminary data are intriguing, and our results provide support for the hypothesis that patients with migraine that is characterized by imploding and ocular headaches are more responsive to botulinum toxin type A than those with migraine characterized by exploding headaches. Our findings invite consideration of using botulinum toxin type A injections to prevent migraine headaches and may promote the role of the dermatologist in the treatment of patients with migraine. However, well-controlled trials need to be conducted to confirm these findings.”

Anesthetic approach stops pain without affecting motor function
Anesthetics work by inducing a nerve block that eliminates sensation of pain. However, a long-lasting never block adversely affects motor functioning. Researchers at Children’s Hospital Boston are testing a substance that might potentially be the ideal anesthetic that stops the pain without affecting motor function. So far, the substance has shown promise in rats. Anesthetics without motor function effect can be very useful, for example, ”a  local anesthetic for childbirth that would block pain without interfering with the mother’s ability to push, or for musculoskeletal disorders in which it is important to maintain mobility.”

Taking the pain out of injections
Finally, there is the pain that comes with injections. The jab pain may not be that painful for adults but can be traumatic for children. If needle pain and fear are not properly managed, it can turn into a phobia that will track through to adulthood, and well, present some health care problems in the future. Get here some tips on how to take the “ouch” out of children’s injections.

Heart(y) news, January 29

January 29, 2010 by  
Filed under HEART AND STROKE

Some news updates on heart issues for you this on this cold and snowy weekend.

FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients Device Provides Support for Those Who Are Not Acceptable Transplant Candidates
There have been several FDA approvals of medical devices. One such device, HeartMate II, was approved earlier this month. HeartMate II is a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation. It is indicated for patients for patients waiting for more complex procedures, including transplants. Here is how the device works:
Heart assist devices are surgically implanted mechanical pumps that help the heart’s ventricle pump blood to the rest of the body. HeartMate II consists of a small, lightweight blood pump implanted in a patient’s chest just below the heart. An electrical cable that powers the blood pump passes through the patient’s skin to an external controller worn around the patient’s waist.

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
The US FDA has issued a communication regarding the safety of the weight loss drug Meridia (sibutramine hydrochloride). Recent evidence showed that the drug can increase the risk for cardiovascular events such as heart attack and stroke. The FDA is advising health professionals not the use Meridia in patients with a history of cardiovascular disease.

FDA Approves First Percutaneous Heart Valve
The US FDA also approved this month the Melody Transcatheter Pulmonary Valve and Ensemble Delivery System by Medtronic. The device is the first percutaneous heart valve which can be implanted through a catheter, or tube, in a leg vein and guided up to the heart. The big advantage of this device is that it is less invasive than an open-heart surgery and can in fact delay the need for a more invasive intervention. It is intended to replace conduits, surgical implants used to treat patients with ccongenital heart defects of the pulmonary valve.
According to Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health:
“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart conditionCongenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”

Cleveland Clinic Health Chats
Several heart(y) topics are on at the Cleveland Clinic Health Chats this coming February:

Have a nice weekend!

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NOTE: The contents in this blog are for informational purposes only, and should not be construed as medical advice, diagnosis, treatment or a substitute for professional care. Always seek the advice of your physician or other qualified health professional before making changes to any existing treatment or program. Some of the information presented in this blog may already be out of date.