The Violent Torpedo of Truth

Frankly, Word on Health is sick and tired of the whole Charlie Sheen thing.  Nevertheless, lots of people, it seems are not only transfixed, but addicted, to watching him break down, one piece at a time.

Now, some experts have suggested that this may help people with their own mental health. Given all that’s been going on around the world, the crisis in the Middle East, the economy, rising gas prices and, most recently, the heartbreaking destruction in Japan, it appears that people welcome a distraction that doesn’t affect them personally.

In the book Understanding Other People: The Five Secrets to Human Behavior, author, Beverly Flaxington says that watching Sheen can make people reflect positively on their own lives.  While the actor’s recent antics, may be symptomatic of a mental health crisis, Flaxington argues that watching Sheen’s personal and professional unraveling has been somewhat of a respite for many people.

It has many of us thinking, ‘I have challenges in my life, but unlike him, I’m holding it together,’ ” she said.

While some people enjoy the “mighty have fallen” aspects of Sheen’s behavior, Flaxington believes that there’s also a little bit of his behavior that we all connect to. “We’re all capable of doings things we’re not proud of. He has us wondering, ‘Under enough stress, could I get to that point?’

Yes, but thank goodness most of us are doing a lot better than he is. Now that’s what we call Winning!

Exercise Keeps You Young

Duh, not exactly the sort of groundbreaking news you’ve come to expect from SRxA’s Word on Health.  However, before you click away from our humble blog, today we’re asking and answering the question “Just how young?”

Well, how about no gray hair, lots of energy, superior muscle mass and brain volume, and that’s just for starters.

At least that’s the case in mice. According to Canadian researchers when mice, who were genetically programmed to age quickly, exercised regularly starting at 3 months old for five month,s they aged dramatically differently than the mice who were sedentary. Those poor inactive mice were balding and frail, while the super-mice who ran the equivalent of a human 10K (6 miles), three times a week starting at age 20, were lean, muscular and youthful. They did not have the expected age-related shrinkage of their brains, hearts, muscles, skin, hair, ovaries, testicles, spleen, kidneys, and liver.

They were even were able to balance on narrow rods…though why a mouse would want to do that is beyond us!

The explanation for these incredible findings appears to be in the mitochondria. Aging in humans cause mitochondria to malfunction and die making you  look older. Additionally, anything that reduces the number or efficiency of mitochondria interferes with your body’s ability to burn fat and sugar for energy.  As a result, blood sugar, fat and cholesterol levels rise and you gain weight.

Exercise however, increases the number and size of mitochondria in your cells .

No doubt, the fact that their gonads were healthy made the students working with researcher, Dr. Mark Tarnopolsky, a professor of pediatrics at McMaster University in Hamilton, Ontario, very, very impressed (and quite possibly, training for their first marathon).

We’d love to tell you more, but we too are going out for a run!

FDA Gets Tough on Asthma Drugs

The U.S. Food and Drug Administration (FDA)  has ordered four drug manufacturers to conduct additional post-marketing clinical trials of their long-acting beta-agonists (LABAs).  LABAs to be studied are AstraZeneca’s Symbicort, GlaxoSmithKline’s Advair Diskus, Merck and Co.’s Dulera, and Novartis AG’s Foradil.

The clinical trials will examine the use of LABAs when used in combination with inhaled steroids. Each of the LABAs plus a corticosteroid will be compared with the steroid alone in patients 12 years of age and older. A total of 46,800 patients will be studied.  Another trial will include 6,200 younger patients, aged 4 to 11, using Advair Diskus.

Last June, the FDA issued warnings on LABAs, saying they should never be used on their own to treat asthma. Although LABAs relax the muscles of the airway to help patients breathe easier, they can cause an increased risk of asthma symptoms that can lead to hospitalizations and death.

The studies will begin later this year, but results are not expected until 2017.

The huge size of the studies signals that FDA wants to be completely sure about the safety profile of these drugs as they are used so widely.

Clearly however, such large study populations might pose financial challenges for the manufacturers.

As of now, Word on Health has heard that Glaxo plans to fully comply with the requirement and Astra Zeneca is finalizing their study protocol with the agency.

Novartis said it was still reviewing the post-marketing requirements issued by the FDA, while Merck said it would have a comment shortly.

We’ll of course bring you updates as they occur.

Dangerous Doses

The use of pharmaceutical medications is an essential element of the American health care system. For many people these prescribed drugs help to treat acute illnesses and maintain control of chronic conditions. However, medication use can also result in side effects. These may occur when treatment goes beyond the desired effect such as a hemorrhage triggered by the use of anticoagulants like warfarin or heparin; or problems that occur in addition to the desired therapeutic effect i.e. the nausea, vomiting, fatigue and  hair loss associated with chemotherapy drugs used to treat cancer.

In other words, side effects can occur as a result of unintentional overdosing by the patient, medication errors such as incorrect prescribing and dosing and even when drugs are taken as directed.

Even so, SRxA’s Word on Health was shocked to read the latest News and Numbers from the Agency for Healthcare Research and Quality (AHRQ).

It seems the rates of medication-related adverse outcomes are increasing. More worrisome, this trend is likely to continue with the aging of the population, the growth in the number of comorbidities, and so called polypharmacy – when patients take multiple drugs, often way more than they need.

According to the report released last week, the number of people treated in U.S. hospitals for illnesses and injuries resulting from taking medicines jumped 52%  between 2004 and 2008.

They now estimate that each year close to 1.9 million Americans suffer either medication side effects or injuries caused by being given the wrong medicine or dosage.

The top 5 categories of medicines that resulted in people being treated and released from emergency departments were:

  • unspecified medicines  
  • pain killers
  • antibiotics
  • tranquilizers and antidepressants
  • corticosteroids and other hormones

For patients admitted to the hospital, the top five categories causing side effects and injuries were: corticosteroids, painkillers, blood-thinners, drugs to treat cancer and immune system disorders and heart and blood pressure medicines.

More than half of hospitalized patients were age 65 or older, while only 3% were under age 18. Children and teenagers accounted for 22% of emergency cases.

The increase in medication side effects coupled with the ensuing massive drain of healthcare finances and manpower suggest to us that pharmaceutical companies need to dedicate more resources to ensure that both doctors and patients are educated about side effects and how to recognize, minimize and manage them.

Cracking the Code for the Common Cold

Medicine has been chasing the elusive cure for the common cold for many long years now.  Try as they might though, it keeps eluding them.

But maybe not for much longer, or so say researchers from the University of Wisconsin, Madison. Using sinus tissue removed during surgery they have managed to grow a recently discovered species of human rhinovirus (HRV), the most frequent cause of the common cold.

The researchers found that the virus, which is associated with up to half of all HRV infections in children, has reproductive properties that differ from those of other members of the HRV family. The accomplishments, reported in Nature Medicine on April 11, should allow antiviral compounds to be screened to see if they stop the virus from growing.

The report sheds light on HRV-C, the newest member of the HRV family. Discovered five years ago, HRV-C has been notoriously difficult to grow in standard cell cultures and, therefore, impossible to study. In addition to its major role in the common cold, HRV-C is responsible for between 50 and 80% of asthma attacks. It is a frequent cause of wheezing illnesses in infants and may be especially likely to cause asthma attacks in children. HRV infections of all kinds also can greatly worsen chronic lung diseases such as cystic fibrosis and chronic obstructive pulmonary disease.

Like other scientists, Yury Bochkov, a virologist at the UW-Madison School of Medicine and Public Health was unable to grow HRV-C in standard cell lines. So he turned to nasal tissue collected following sinus surgery and was surprised to find success. He grew significant amounts of two forms of HRV-C, then sequenced the complete virus genome and engineered an identical copy of it in a plasmid vector.

Studying the reproduction of the living, growing virus, he found that HRV-C replication appeared to occur in specific kinds of cells localized in nasal epithelium tissue.  “We also found that HRV-C does not attach to the two receptors that HRV-A and HRV-B use,” Bochkov says. “HRV-C uses a distinct, yet unknown, receptor that is absent or under-expressed in many cell lines.”

Future drugs emanating from this research could be especially useful for children and adults who have asthma and other lung problems.

But we’re not there yet!  In the meantime, SRxA’s Word on Health suggests we continue doing what our mothers have been telling us for years. Drink plenty of fluids, gargle with salt water and, of course, chicken soup.

Pharma-Physician Interactions Perceived Positively

According to a survey released last week, nearly eight out of 10 physicians view pharmaceutical research companies and their sales representatives as useful sources of information on prescription medicines.

That’s good news for pharmaceutical marketers who spent $24 billion between October 2009 and September 2010 on physician-targeted promotional spending, and an additional $1 billion on continuing medical education.

The telephone survey of more than 500 American Medical Association members found that physicians consider a range of sources useful for staying informed about medicines. In addition to sales reps and company-sponsored peer education programs, doctors also rated continuing medical education (CME) courses, peer-reviewed medical journals, and their fellow physicians as useful sources of information.

The survey also found that physicians consider a broad range of factors in making their prescribing decisions, with almost all respondents relying on their clinical knowledge and experience as well as a patient’s response to a particular medicine. More than 80% reported that they take into consideration a patient’s insurance factors, such as formulary and prior authorization requirements, with just under 70% using information provided by pharmaceutical company representatives

The survey, which was supported by PhRMA, also looked closely at how physician respondents view their interactions with pharmaceutical company representatives.

More than 90% responded that interactions with representatives allow them to learn about new indications for approved medicines, potential side effects of medicines, and both emerging benefits and risks of medicines.  In addition, 84% of physicians said that interactions with representatives allow them the opportunity to provide feedback to a pharmaceutical company about their experiences with a specific medicine.  Large majorities also found information from company representatives to be up-to-date and timely (94 %), useful (92%), and reliable (84%).

The survey also included several questions about company-sponsored peer education programs, in which physicians present to their peers. Nearly 9 out of 10 of physicians who reported attending these programs said the information was up-to-date, useful and reliable.

Physicians attending peer education programs reported gaining a range of information, including: improved clinical knowledge (98%), potential side effects of medicines (97% ), new uses of medicines (97%), the range of treatment options (97%), and emerging drug risks (95%). Importantly, 94% said the programs strengthened their ability to care for patients.

Peer education programs allow physicians to have important dialogues with their expert colleagues. This sharing of information ultimately benefits the patients they treat,” said PhRMA’s John Castellani.

SRxA and its team of independent Clinical Advisors specializes in providing support to the pharmaceutical industry and has developed a number of highly successful and unique peer-to-peer education programs. For more information, contact us today.

A New Reality for Stroke Patients?

Traditional post-stroke rehabilitation programs are designed to improve motor and sensory abilities. With the help of specially trained nurses, physical, and occupational therapists survivors relearn the skills needed for activities such as personal grooming, preparing meals, and housecleaning.  This may all be about to change.

A new study has shown that virtual reality games may be the key to recovery. The results show that the patients were more likely to improve their arm strength if they played virtual reality games than if they received standard physical therapy.  The study will be published in the May issue of Stroke.

Stroke survivors suffer mobility problems when parts of the brain controlling leg or arm muscles are impaired. Rehabilitation exercises can help the brain create new connections between nerve cells. Yet, according to study researcher Dr. Gustavo Saposnik, Director of the Stroke Outcomes Research Unit at St. Michael’s Hospital at the University of Toronto, standard therapies provide only modest benefits in terms of improving mobility.

Virtual reality games have been adapted to aid in stroke rehabilitation. In these games, patients interact with a virtual world. They can be immersed in this world by placing a display screen over their eyes, or they can interact with a computer or TV screen, just as they would with a standard video game. The virtual reality games vary in the tasks they ask subjects to perform. Some games require patients to manipulate virtual objects. Other games, including those played on the Nintendo Wii, may require patients to flex their arms and wrists.

Saposnik and his colleagues analyzed 12 studies that tested the effects of virtual reality and electronic games on stroke recovery.

Five of the studies were trials in which patients were randomly assigned to receive standard therapy or play virtual reality games. Taken together, these studies showed patients who played virtual reality games were about 5 times more likely to improve their upper body strength than those who received the standard therapy.

The other seven studies looked at patient improvement before and after playing the games. These studies found on average, a 14.7% improvement in patients’ grip strength and a 20% improvement in their ability to perform standard tasks.

Virtual reality games activate different parts of the brain than standard therapies, which may explain the greater improvement seen in patients who played the games.  The games also activate mirror neurons which are a special type of nerve cell that fire when a person observes someone else performing a particular movement. “Engaging the mirror neuron system probably facilitates the formation of new brain connections and aids in recovery,” Saposnik said.  In addition, virtual reality games can provide auditory and sensory feedback that is important for rehabilitation.

Larger trials are now planned to determine the true benefit of the games.

Have virtual reality games helped you or anyone you know recover from illness?  SRxA’s Word on Health would love to hear from you.

Statistical Significance is Nothing to be Sneezed at Says US Supreme Court

If you have ever had a stuffy nose or invested your hard-earned cash in the stock market, the facts of a recent Supreme Court case will probably disturb you.

The case, Matrixx Initiatives Inc. v. Siracusano involved the popular homeopathic nose spray – Zicam.

This product was responsible for the vast majority of Matrixx’s revenues, and investors loved the company because the nasal remedy sold well.  The stock price soared, but then the company learned that Zicam had caused some users to lose their sense of smell.  As it turned out,  approximately 130 users had reported the adverse side effect, the medical term for which is anosmia.

Although the common view of anosmia is that it is a trivial inconvenience, it can have a number of harmful effects.  Not only do patients find food less appetizing, their loss of smell can also be dangerous because it hinders the detection of gas leaks, fire, and spoiled food. Loss of smell may also lead to the loss of libido.

Matrixx, however, concerned that the news would lead to a loss in sales, decided not to report the rare side effect to investors.    The company’s reasoning?  The side effect was not the kind of “material information” that securities laws would require it to disclose because it was not statistically significant when considered in the context of the patients who had used the drug.

The problem for Matrixx arose when national news got wind of the anosmia side effect.  This lead to the issue of FDA warnings and ultimately Matrixx’s decision to take the drug off the market, causing stock prices to fall.

So, investors sued the company saying that the undisclosed information was indeed “material” and might have caused them to make a different decision about whether to buy Matrixx stock.

During the trial, in a brief to the court, PhRMA said, “A collection of adverse event reports that is not statistically significant does not permit a reasonable inference that a particular medicine actually caused the reported adverse event.”

The Supreme Court disagreed.  In a unanimous opinion by Justice Sotomayor, it made clear that the word “material” does not equate with “statistically significant”.  Instead, the Court said, the important consideration is what information a reasonable investor would regard as relevant to the decision to buy stock; such an inquiry would include questions about the source and reliability of the information.  While not all reports to authorities about side effects would be material under this test, the Court held, those about the Zicam side effect would have been because they came from medical experts.

While almost everyone involved in pharmaceutical marketing is aware of the FDA’s “Fair Balance” requirements it seems that full disclosure must now include all corporate, as well as product, information.  In fact, the Supreme Court ruling may have greater repercussions for adverse event reporting by the drug industry than any guidelines the FDA has ever issued!

Hospital errors affect 1:3 patients

How common are hospital errors?

A shocking new study suggests that the number of “adverse events” befalling patients in U.S. hospitals may be 10 times higher than previous estimates.

If the authors are correct, this would mean that medical mistakes affect one in three people hospitalized  in the US. The study, published in the journal Health Affairs involved a review of almost 800 patient charts at three U.S. hospitals. Using a review technique known as the “global trigger tool,”  researchers detected a whopping 354 adverse events. Scarier still,  that figure might actually understate the enormity of the problem as it was based on potentially incomplete medical records rather than on direct observation in real time.

Dr. David C. Classen of the University of Utah believes his study gives a more reliable tally of hospital errors than other studies, including a 1999 landmark study from the Institute of Medicine entitled To Err is Human showing that hospital errors caused up to 98,000 Americans each year.

So what sorts of events were uncovered in the new review? According to Classen, there were three big ones:

The question many are now asking: is the new estimate accurate?

It is hard to know that to make of the trigger tool,” admits Dr. Peter J. Pronovost, a Professor in the Johns Hopkins University School of Medicine (Departments of Anesthesiology and Critical Care Medicine, and Surgery) and Medical Director for the Center for Innovation in Quality Patient Care.

However, “Far too many patients suffer preventable harm in the U.S.” he added.

Other recent studies appear to confirm Classen’s findings.

Earlier this month the US government released data for the first time, showing how often patients are injured by certain medical errors in hospitals.  However, only eight types of serious, preventable errors were included in the comparison.

They were: air in the bloodstream, falls, bedsores, transfusions with the wrong blood type, urinary tract infections, blood infections, uncontrolled blood-sugar levels and foreign objects left in the body after surgery.

Other serious events, including wrong-site surgeries and medication errors, were not included.

And late last year, the Office of Inspector General for the U.S. Department of Health and Human Services said 180,000 Medicare recipients die each year from hospital mistakes. That’s more people than are killed every year in car crashes, or from diabetes or pneumonia.

Without doubt, health care has improved over the past decade, but it’s clear that there is still a great deal of work to do in order to achieve a health care system that safe, effective, patient-centered, efficient, timely, and devoid of disparities based on race or ethnicity.

Until then, SRxA’s Word on Health advises that if you think something is amiss or wrong with your hospital care, speak up.

Heart Patients want to share their Shocking Devices

Almost everyone has seen a doctor on television, yelling “Clear!”, then applying paddles to the chest of a patient to shock him “back to life”.

As dramatic, as the scene may be, defibrillation can only be used for the deadliest forms of arrhythmias – ventricular tachycardia (V-Tach) and ventricular fibrillation (V-Fib) and not for patients who have “flat-lined” (asystole).

For those who are at high risk of V-Fib and V-Tach  an internal “shocking” device may provide the best defense against sudden cardiac arrest. Such a device, known as an implantable cardiac defibrillator (ICD), is considered effective in fighting cardiac arrest over 90% of the time.

Each year, more than 100,000 patients in the U.S. undergo implantation of an ICD. This number constitutes a 20-fold increase over the last 15 years.

Current medical guidelines advocate discussion of end of life care of these medical devices, including deactivation. Now, researchers at the University of Pennsylvania School of Medicine say that discussions should also address post-mortem donation of ICDs for product improvement or reuse overseas as pacemakers, to help reduce global health disparities.

Penn researchers conducted a phone survey of 153 ICD patients concerning advance directives and ICD handling at the end of life. The study results which were reported at the 2011 American College of Cardiology meeting in New Orleans showed that half of the patients that were questioned said they would like their ICD deactivated in an end of life illness. Most also thought that a do not resuscitate (DNR) order justified ICD deactivation.

Although 17% reported ever thinking about ICDs in an end of life illness; just two patients had actually addressed the topic in an advance directive arrangement and only 5% of the patients had ever discussed ICD deactivation directly with their doctor.

Regarding donation of ICDs for reuse or review of the device for improvement purposes, 88% said they would donate their device to facilitate product improvement, 87% would donate for reuse overseas, and 80% for reuse in animals. When asked to choose just one donation option, the majority of patients would donate their devices for reuse in patients overseas.

Shocking or sensible?  SRxA’s Word on Health would love to hear your thoughts on this.