Dieters Delight

If  the first thing you do when  grocery shopping is check the label for calorie content, then we have some welcome news.   Scientists estimate that calorie counts on food labels may be off by as much as 25%.

For example, independent nutritionists found that a small pepperoni pizza had only 386 calories compared to the 422 stated on the label.

Calorie calculation was created 120 years ago.  Using a device called a bomb calorimeter, American agricultural chemist Wilbur Olin Atwater burned food samples and measured the amount of energy released from the heat this produced.  He then estimated the amount of this energy the body used up, by calculating the energy of undigested food in feces and other waste products.   Atwater concluded that every gram of carbohydrates produced four calories, every gram of fat, nine calories and every gram of protein, four calories.

Ever since, these figures have been set in stone.

However new research by independent nutritionist Dr. Geoffrey Livesey, and others, has shown that the amount of calories we digest in certain foods varies. Livesey therefore suggests that the calorie content of food should be re-calculated according to its Net Metabolizable Energy otherwise known as the amount of calories left  for your body to use after the calories used in digesting it have been subtracted.  ‘We need to take into account all the considerable knowledge we have learnt since 1889 and start applying it,” said Dr. Livesey.

His findings were reviewed by the World Health Organization in 2007, which concluded his research was sound.

Your Word on Health bloggers will be celebrating the demise of calories this lunchtime with pepperoni pizza!  What else?!?

Walgreens tells Washington: No profit – no drugs

Walgreen’s has put the State of Washington on notice.   Because Washington has not adjusted its Medicaid reimbursements, branded script reimbursement does not cover Walgreens’ costs.   Effective April 16, none of the 121 Walgreen’s pharmacies operating in Washington will accept any new Medicaid patients.

“Obviously, we’re disappointed that the alternatives we’ve suggested have failed to achieve a compromise,” said Kermit Crawford, Walgreens Executive VP of Pharmacy. “We intend to continue our commitment to serving our existing patients, but we simply cannot take on additional losses.”

As government intervention and manipulation of the free market continues apace, Word on Health is concerned about the effect this will have on prescription drug manufacturers.

As if the prospect of Government mandated use of generics is not enough to cripple the branded prescription market, if prescription products can be substituted with OTC products paid out of the consumer’s pocket, both third party payers and OTC manufacturers would benefit.

To a large degree major Rx/OTC shifts have already happened for chronic disease therapies, i.e.

• non-sedating anti-histamines (allergy)
• non-steroidal anti-inflammatories (arthritis)
• proton pump inhibitors (reflux)

However, since all chain pharmacies situate the pharmacist at the rear of the store to enhance impulse purchases of OTC products, the decrease in foot traffic from prescriptions could decrease OTC sales too.

Time for another healthcare reform? Word on Health wants to hear from you.

Bursting the Bubble!

For many Americans, their only knowledge of Primary Immune Deficiency (PID) disease is the much maligned movie Bubble Boy.  The film was inspired by the true story of David Vetter who suffered from the rare genetic disease severe combined immune deficiency syndrome (SCID). Because of his inability to fight infections, David spent most of his short life living in a series of sterile bubbles.

However, the reality of PID is very different.  First off, it’s not one disease. The World Health Organization recognizes over 150 different forms of PID. Some, such as selective IgA deficiency, are not even that rare, affecting as many as 1:500 of the population.  Furthermore, today, if a baby like David receives a bone marrow transplant within the first 3.5 months of life, the survival rate can be as high as 94 percent.  For many of the other PID diseases, patients can live healthy and productive lives with the help of replacement immune globulin therapy.

Produced from the plasma of thousands of healthy donors, immunoglobulin, is a concentrated mixture of antibodies that provides the patient with an “artificial immune system.”  When first developed in the 1950’s, the treatment was administered by painful intramuscular injections (IMIG).

In the 1970’s, the first intravenous immunoglobulin (IVIG) preparations were developed. These quickly became the standard of therapy, as they were more effective, reducing both the need for antibiotics and hospitalizations for infections.  However, the required monthly infusions could take several hours and were associated with a high incidence of side effects.

In 2006 the FDA approved the first subcutaneous immunoglobulin (SCIg) therapy for PID. Because SCIg can be self-administered, patients can schedule infusions to suit their own lifestyle. The dosage schedule  also allows patients to maintain more consistent immunoglobulin levels and for some, SCIg is also associated with fewer side-effects.

Last week, life got even better for these patients.  CSL Behring announced that the U.S. Food and Drug Administration (FDA) had granted marketing approval for Hizentra™, Immune Globulin Subcutaneous (Human), 20% Liquid. Hizentra is the first 20% concentration SCIg. This concentration enable patients to administer up to 20g of IgG in a single infusion, making it the first once weekly SCIg. It’s also the first SCIg to be stabilized with L-proline, allowing the product to be stored at room temperature.

“With its high concentration, Hizentra is a welcome new SCIg treatment option for patients managing primary immunodeficiencies,” said John Sleasman, M.D., Professor and Chief of the Division of Allergy, Immunology and Rheumatology at the University of South Florida College of Medicine, Department of Pediatrics. “Hizentra’s ready-to-use attribute will allow patients to infuse the product where and when it suits them, and physicians now have another product to select to best meet the individual needs of their patients.”

SRxA and Word on Health congratulate CSL Behring on developing a product that will truly improve the lives of patients with PID.

Brand Building

Word on Health commends Bud Bilanich on an article he authored for the March 2010 edition of PM360.

Entitled Building a Remarkable Brand is a Never Ending Process, Bilanich encourages pharmaceutical Product Managers to embrace the concepts of Maslow’s hierarchy of needs.

Maslow suggested that all human beings have a series of needs they strive to satisfy and arranged these needs in a pyramid. Self-actualization is at the top of the pyramid. Maslow says that after our safety, security, affiliation, and recognition needs are satisfied, we turn our attention to self-actualization although we never actually accomplish it because as soon as we reach one goal, we realize there is always something more to do.

Bilanich advises pharmaceutical marketers to think of their brand this way too. He tells readers a brand can always become something more; there will always be more to do, more to accomplish.  His advice:

• Commit to taking personal responsibility for the brand you manage
• Set high goals for your brand
• Do whatever it takes to meet or exceed those goals
• React positively to the setbacks, problems, and negative people and events in your life
• Keep at it
• Don’t let a day when you come back empty-handed in your quest for building a remarkable brand get you down
• Get up the next day with optimism in your heart and keep working toward creating a remarkable brand for the product with which you have been entrusted

SRxA‘s team of experts is on standby to help you achieve all  your brand goals and self-actualization.  Contact us today to get started.

A banana a day keeps HIV away?

Yes, you read that right, and no, this isn’t our attempt at an early April Fool’s day story.  Your favorite fruit really might be even healthier for you than you thought.

Scientists have discovered that bananas may hold the key to preventing sexual transmission of HIV. Researchers from the University of Michigan Medical School have shown that a chemical found in bananas is better at preventing HIV than two current synthetic anti-HIV drugs.

The miracle substance is called BanLec, a type of lectin.

BanLec, works by binding to the sugar-rich envelope that encases the HIV virus and blocks its entry into the body.  BanLec could therefore be incorporated into a vaginal ointment and could be self-applied before sexual contact.  Researchers believe it would be much cheaper to produce and distribute than most current anti-retroviral medications which require the production of synthetic components.

One thing’s for sure: new ways of stopping the transmission of HIV are desperately needed. “HIV is still rampant in the U.S. and the explosion in poorer countries continues to be a problem” said study senior author Professor David Marvovitz, M.D.

Condoms are effective, but they are often used incorrectly or inconsistently.

Although clinical use of BanLec is probably years away, researchers believe that even modest success could save millions of lives. They estimate that if as little as 20% of the “at risk” population used a drug that is only 60 percent effective against HIV, it could still prevent up to 2.5 million infections over the course of three years.

It’s been more than two decades since HIV and AIDS began sweeping the globe, during which time hundreds of billions of dollars have been spent on research and the elusive hunt for a vaccine or a cure.  Who’d have thought  that the answer may have been literally hanging in front of us all this time?

Hopes and Hurdles for HAE

People with hereditary angioedema (HAE) have several new therapeutic options to prevent and treat this debilitating genetic disease.

HAE is a disorder characterized by recurrent episodes of severe swelling (angioedema). The most common areas of the body to develop swelling are the limbs, face, intestinal tract, and airway, but any organ can be affected. Minor trauma or stress may trigger an attack, but swelling often occurs without a known trigger.

The inflammation can be disfiguring, debilitating or even life-threatening.  Episodes involving the intestinal tract cause severe abdominal pain, nausea, and vomiting.  Swelling in the airway can restrict breathing and lead to obstruction of the airway.

If left untreated, HAE can result in a mortality rate as high as 40% primarily due to upper airway obstruction.

Symptoms of HAE typically begin in childhood and worsen during puberty. Untreated individuals have an attack every 1 to 2 weeks, and most episodes last for about 3 to 4 days. The frequency and duration of attacks vary greatly.

HAE is estimated to affect 1 in 50,000 people worldwide.  7,000 people have been identified with the disease in North America.   It is caused by a deficiency or malfunction of C1 esterase inhibitor – a protein normally found in blood plasma.

Until recently in the US there were no specific treatments for HAE and individuals had to endure frequent grueling and potentially life-threatening attacks.

However in less than 6 months the FDA has approved three novel HAE drugs:

• Cinryze, (C1 esterase inhibitor [human]) approved to prevent HAE attacks.
• Berinert, (C1 esterase inhibitor [human]) approved for treating acute facial and abdominal HAE attacks
• Kalbitor, (ecallantide) approved for treating acute attacks in patients 16 yrs and older

Now that treatments are available, the next hurdle is to improve early recognition and diagnosis. It is estimated that HAE attacks account for approximately 15,000 to 30,000 emergency department visits per year.  But because symptoms of HAE may resemble appendicitis or other medical conditions, many patients undergo painful, often lengthy and expensive procedures and unnecessary surgery before their condition is eventually recognized.

We spoke to Dr. Michael Kaliner who provides care for one of the largest HAE patient populations in the country.  He told us, “As with so many other rare diseases, education is the key.  Physicians experienced in recognizing and treating HAE need to be talking to emergency room staff.”

As awareness of the condition is low, it is estimated that only 50% of HAE patients in the world are correctly diagnosed and managed today.  Word on Health hopes that this post will be the first step in increasing awareness.  SRxA and our expert Advisors, including some of the worlds leading authorities on HAE,  are ready to help manufacturers and patient support groups take the next steps. Contact us today for more information.

Mood Monitoring

Word on Health was interested to hear about a simple, free online diagnostic tool that helps patients and primary care doctors screen for four common psychiatric illnesses: depression, bipolar disorder, anxiety disorders and post-traumatic stress disorder.

Developed by M-3 Information and validated by researchers at the University of North Carolina at Chapel Hill, the 27-item questionnaire can detect a mood disorder with approximately 80% accuracy.

This is good news for the 1 in 10 Americans who suffer from depression and other mental-health disorders but never receive treatment because they don’t understand what’s wrong.

Bradley Gaynes, M.D., M.P.H, lead author of the study and an associate professor of psychiatry in the University of North Carolina at Chapel Hill School of Medicine said “For millions of people, a single tool that can screen for multiple disorders would be very helpful.”

M-3 has also developed a mobile phone version of the checklist that will be released shortly.  In the meantime, Word on Health readers can take their mental health pulse at http://www.mymoodmonitor.com/

Behind the bedroom door

It’s well known that infertility is on the increase.  Recent data suggests that fertility issues affect about 1 in 8 couples worldwide. The impact of an infertility diagnosis can be devastating enough.  But for men, procreativity is so closely linked with sexuality, many feel that their masculinity is being questioned.  Fear of being  publicly revealed as the cause of the couples failure to conceive prevents many men from undergoing testing.

So it was with interest that Word on Health learned about a new home test kit that can assist couples in determining if a man’s sperm count is normal, low, or very low, in the privacy of their own homes.

The test, appropriately called SpermCheck,  is based on the levels of a particular protein in sperm.  The test has already been approved in the EU and is currently undergoing FDA review.

“The SpermCheck Fertility test is designed as a first line assay for use by couples who suspect infertility. The test is also useful for men of any age who simply want to know if their sperm count is in the normal range. After reading the results couples can determine whether to seek comprehensive clinical evaluation of the male partner’s fertility status,”  explains John Herr, PhD who discovered the protein . “This self-test could save money and time for couples struggling with infertility by identifying which partner may need further evaluation.”

Word on Health wonders if we should keep “mum” on this !?!

To your Health—Bottoms up!

A new study suggests that sipping pale-colored beer may benefit bone health in women. Researchers at the Department of Food Science & Technology at the University of California, Davis studied commercial beer production methods and the resulting silicon content.  Beer, a rich source of dietary silicon, may help to increase bone mineral density.  Dietary silicon may be important not only for the growth and development of bone tissue, but connective tissue as well.

Based on these findings, some studies suggest moderate beer consumption may help fight osteoporosis, a disease of the skeletal system characterized by low bone mass and deterioration of bone tissue. Osteoporosis affects 10 million Americans, and almost 34 million more are estimated to have low bone mass, placing them at an increased risk for osteoporosis, according to the National Osteoporosis Foundation (NOF).  NOF  estimates that 80% of osteoporosis sufferers are women.

Your SRxA Bloggers are thrilled to hear of the UCD researchers’ findings, and plan to partake in bone-loss preventive measures as soon as possible.  Cheers!

No excuse for sleeping on the job!

SRxA Word on Health bloggers know just how hard pharmaceutical and business execs work. The deadlines, the late nights, the weekends and of course, the crazy travel schedules. With all this sleep deprivation you’d think we’d all be forgiven the occasional lapse of judgment.

Not so, says a new study!

Research conducted at Washington State University into the effects of sleep deprivation on executive functioning and published in the January 2010 issue of the journal Sleep has yielded surprising results.

The study looked at 23 subjects, who spent 6.5 consecutive days in a controlled laboratory environment. One group was kept awake for two consecutive nights, while the other was on a normal sleep schedule.

Three times during the experiment, subjects were asked to complete a series of executive tasks that measured working memory, scanning efficiency, resistance to proactive interference and verbal fluency.

The research psychologists found that working memory -a key element of executive functioning- was essentially unaffected by as much as 51 hours of total sleep deprivation. Instead, they saw a degradation of non-executive components such as information intake.

Follow-up studies will examine how distinct components of decision making are affected by sleep deprivation and how this influences the overall decision-making. Ultimately, this may lead to development of interventions that will improve decision-making in emergency responders, police officers, and military personnel for whom getting enough sleep is often not an option.

Meanwhile, with tiredness no longer an acceptable excuse for bad business decisions, we wonder if this mean the end of the executive power-nap?!?