Generic drug could save lives of accident victims

A study just published in The Lancet suggests that routine use of the generic drug tranexamic acid in trauma patients could save as many as 100,000 lives a year.  Lead researcher, Ian Roberts, commented: “This is one of the cheapest ways ever to save a life,” adding that the drug “should be available to doctors treating trauma patients in all countries.”

The CRASH-2 trial was undertaken in 274 hospitals in 40 countries and included  20,211 adult trauma patients.  Those with, or at risk of, bleeding received either tranexamic acid, or placebo, within 8 hours of injury. Results showed that treatment with tranexamic acid reduced deaths from hemorrhage by 15% percent, and deaths from any other cause by 10%, compared to placebo.

Tranexamic acid is an antifibrinolytic agent.  In other words, it prevents breakdown of blood clots.  It is routinely used to control bleeding in women with heavy menstrual periods, bleeding associated with uterine fibroids, to control blood loss in orthopedic surgery and as a mouth rinse after dental extractions or surgery in patients with prolonged bleeding time from acquired or inherited disorders.

Following the study, Roberts and colleagues submitted an application to the World Health Organization to include tranexamic acid on its essential medicines list.

Heightened Scrutiny of Food & Supplement Health Claims

Health claims made by food and nutritional supplement manufacturers should face the same level of regulatory scrutiny as those made by drug and medical device manufacturers, says a new report from the Institute of Medicine (IOM).

Food and nutritional supplement marketers often make health claims based on how individual ingredients in their products affect biomarkers (physiological characteristics that can be measured and evaluated objectively) such as cholesterol or glucose levels or tumor size. Thus, the manufacturer of a breakfast cereal that contains a cholesterol-lowering ingredient, such as fiber, might boast that its cereal has heart health benefits without clinical proof of improved outcomes.

Faced with a proliferation of health claims being made by food and supplement manufacturers, the FDA’s Center for Food Safety and Applied Nutrition asked the IOM in 2008 to recommend a framework for the evaluation of biomarkers.

Commenting on the report, IOM member Harlan Krumholz, MD said, “This is a groundbreaking report that tells us we should really think carefully about the use of biomarkers and surrogates.”

SRxA’s Word on Health is pleased to hear that the food we eat will be given as much attention as the drugs we take, but hopes that the process can be somewhat faster!

Recovery from Spinal Cord Injury – one small step for rats.

Once damaged, nerves in the spinal cord normally cannot grow back, so, as we all know, the patient becomes paralyzed below the area of injury and long-term morbidity results.

Word on Health was therefore cautiously optimistic after reading a new  study published last week in the Early Edition of the Proceedings of the National Academy of Sciences. The pre-clinical data showed that treating injured rat spinal cords with the enzyme – sialidase, improved nerve regrowth, motor recovery and nervous system function.

Sialidase is a bacterial enzyme that removes specific chemical groups found on the surface of nerve cells. The chemical groups normally function to stabilize the cells, but also act to prevent nerve regeneration.

The research team from Johns Hopkins treated rats with lower-back impact injury — severe enough to lose hind-limb function. The rats were injected with sialidase directly over the spinal cord immediately following injury. The researchers then implanted a small intrathecal pump that delivered a steady stream of sialidase directly to the injury over the course of two weeks.  Their hope was that bathing the injured nerves in the enzyme would help their recovery and promote regrowth. They then let the rats recover for another three weeks before assessing the degree of recovery.

Using a well-established, 21-point scale where zero represents paralysis and 21 is normal function, the team of researchers assessed both treated and untreated rats for a range of functions including whether they could lift their feet off the ground and whether they had coordinated leg movements.

The initial injury rendered all rats to score below four, and all rats, treated or not, recovered somewhat by the end of two weeks. By the end of five weeks after injury most untreated rats scored 12 or less, while most treated rats scored better than 15. According to Ronald Schnaar a professor of pharmacology and molecular sciences at Johns Hopkins,  “The difference in coordination control was most remarkable.”

In addition to motor control, spinal cord injury can cause other nervous system problems, including losing the ability to control blood pressure and heart rate. Researchers found that treated animals improved blood pressure control, something they interpreted as improved communication in the spinal cord.  Finally, the team looked at the nerve ends under a microscope and found that treated nerves showed an increased number of “sprouted” nerve ends.

While the data appears promising, as always, we caution that efficacy in animals also doesn’t necessarily translate to humans. Furthermore, it will be a long road to using this as a drug in people. Nevertheless it is a step in the right direction.

Why Women Worry

According to researchers at the Children’s Hospital of Philadelphia, there may be a biological reason why depression and other stress-related psychiatric disorders are more common among women.  Studying stress signaling systems in animal brains, neuroscience researchers found that females are more sensitive to low levels of an important stress hormone and less able to adapt to high levels than males.

The research was published in the June edition of Molecular Psychiatry.

It has long been recognized that women have a higher incidence of depression, post-traumatic stress disorder, and other anxiety disorders, but underlying biological mechanisms for that difference have been unknown.

The research focused on corticotropin-releasing factor (CRF), a hormone that organizes stress responses in mammals.

Analyzing the brains of rats that responded to a swim stress test, investigators found that in female rats, neurons had receptors for CRF that bound more tightly to cell signaling proteins than in male rats, and thus were more responsive to CRF. Furthermore, after exposure to stress, male rats had an adaptive response, called internalization, in their brain cells. Their cells reduced the number of CRF receptors, and became less responsive to the hormone. In female rats this adaptation did not occur because a protein important for this internalization did not bind to the CRF receptor.

This is the first evidence for sex differences in how neurotransmitter receptors traffic signals,” said study leader Rita J. Valentino, Ph.D. “Although more research is certainly necessary to determine whether this translates to humans, this may help to explain why women are twice as vulnerable as men to stress-related disorders.”

So ladies, next time you’re accused of being stressed out, relax.   Just blame it on your CRF.

Time for a new pharma paradigm?

If it ain’t broke don’t fix it!

But what do you do if it is broke? And what do you do if the “it” is healthcare and the “you” is the pharmaceutical industry?

The health landscape as we knew it has changed forever and the genie cannot be put back in the bottle. Industry has to adapt or die.

Industry leaders need to “fix” their sales model in response to the biggest threat the industry has faced since its inception. That threat is commoditization. On every side and in every country there is pressure to reduce prices, especially from governments who face increasing health costs from an aging population, higher expectations and improvements in technologies.

Pharmaceutical company success, like any other business, depends on its ability to acquire and retain customers.  Prescribing decisions are consolidating, there are more competitors, generics and ever-increasing regulations to contend with.  Change although difficult, is necessary.

The redesign of pharmaceutical field operations is probably one of the most strategically important and difficult tasks of senior executives.

In the late nineties two technology giants Xerox and IBM were facing similar structural market problems to the pharmaceutical industry. Both companies were producers of great technologies and manufactured market leading high tech products. Both had established and enormous manufacturing facilities and both companies were reliant on a huge and gifted sales force to create pull through for their products. Both companies were faced with the same problem.  Market entrants were selling similar products far cheaper, customer needs were changing as a result of the digital age and costs of production were too high.

Both companies took a similar view. They had to try and prevent the erosion of their sales base by adding more value to their customers and thus retain premium pricing. To do this both companies sought to move from selling product to selling “solutions”. This new model required dramatic and far reaching cultural changes to the company’s structure and strategies. Solution selling is not the same as product selling. Features and benefits are not part of selling a solution. A solution is a much broader concept it involves bringing together a combination of elements to solve a problem for the customer. In the solution world the term partnership has real meaning.

The Pharmaceutical Industry has to take the same route by providing more value to their customer. And there lies the problem. Industry is no longer able to focus its attention solely on the Clinician.  It is now the payers who call the tune and their motivations are very different from clinicians.

What do the payers want? Although the interest of the patient still lies at the core of their intent payers have twin objectives, the first, to implement government health policy and, the second, to ensure the availability of care within budgetary limits.

Payers are making demands within a changing industry, and in order to benefit from the shifting landscape, pharmaceutical companies must shift away from the traditional payer relationship and in its place, concentrate on how to add value to payers and managed care organizations.

As part of  payer-centric strategy, companies need to develop their value propositions.  Payers need to see a clear statement of the tangible results they will get from using your products or services.  At present, payers are unhappy with the information and models provided to them by life science companies. They are looking for more detailed information about the clinical studies conducted beyond safety and efficacy.  The provision of outcomes data and specific data showing the advantages of your products and service offering is needed.

Strong value propositions should offer tangible results such as

•  Decreased costs (admissions, tests, consultations etc)
•  Improved operational efficiency
•  Reduced patient interventions
•  Reduction in key health issues (obesity, smoking, cholesterol, alcohol consumption)
Together with a team of world class experts in Health Outcomes, SRxA partners with pharmaceutical companies to enhance their value proposition. SRxA can assist with brainstorming, market, customer and clinical research and pharmacoeconomics. The collated results form the basis for the prototype value proposition which is then rigorously tested. In this way a robust story can be developed for the sales teams, to give to the various “customer groups.”

Contact us today and you will have taken the first step to establishing your company as a marker leader in the new healthcare environment.

The Best Father’s Day Gift

Instead of another set of grill tools or yet another tie, a more meaningful gift for Dad this Father’s Day would be to encourage him to get checked for prostate cancer. So say experts at The Cancer Institute of New Jersey (CINJ).

According to the American Cancer Society, prostate cancer is the second most frequently diagnosed cancer in men, (skin cancer is now the #1) and the second leading cause of cancer death in males. It is estimated that approximately 192,000 new cases of prostate cancer will occur in the United States this year, with 27,000 deaths. African American men are at a higher risk of developing prostate cancer.

The good news is that if detected and treated early, the chances of survival are nearly 100 %.

Screening consists of a digital rectal examination and a prostate specific antigen (PSA) blood test.

Most healthy men have PSA levels under 4 ng/mL of blood. The chance of having prostate cancer goes up as the PSA level goes up.

The American Cancer Society recommends that men, especially those with several family members who have had prostate cancer at a young age, should consider screening at age 40. African Americans should begin screening at 45 and most other men at age 50.

Men who choose to be tested and have a very low PSA may only need to be retested every 2 years, whereas they may be tested yearly if their PSA result is higher.

So play it safe this Father’s Day and give your Dad the best gift of all – his health.

Inhaled Insulin as effective as Injected Insulin

Diabetes, affects 26.8 million people in the U.S. It is characterized by the body’s inability to properly regulate  blood sugar levels. Insulin, a hormone produced by the pancreas, normally regulates the body’s glucose levels, but in people with diabetes insufficient levels of insulin are produced or the body fails to respond adequately to the insulin it produces.

Current mealtime insulin therapy has a number of limitations, including the risk of severe hypoglycemia (low blood sugar), weight gain, inadequate post-meal glucose control, the need for complex titration of insulin doses in connection with meals and, of course, the need for injections.

So Word on Health was excited to hear that needles may soon become a thing of the past.  According to the manufacturer, investigational inhaled insulin works at least as well in patients with Type 1 diabetes as standard injection therapy.

MannKind Corporation announced yesterday that a new Phase III clinical trial showed that the ultra fast-acting inhaled insulin AFREZZA (insulin human [rDNA origin]) combined with basal insulin worked at least as well as injectable Humalog (insulin lispro [rDNA origin]).  Additionally, patients receiving the inhaled insulin showed lower rates of hypoglycemia, lower fasting and post-prandial blood glucose levels than those receiving subcutaneous injections

Effectively controlling blood sugar levels and managing hypoglycemic events go hand in hand as key to successfully treating patients with Type 1 diabetes,” said Satish K. Garg, M.D., Professor, Departments of Pediatrics and Medicine, University of Colorado School of Medicine; Head, Young Adult Diabetes Clinic, Barbara Davis Center for Childhood Diabetes, and lead study investigator.   “Our findings demonstrate that AFREZZA may offer a significant advance from current mealtime insulin delivery methods, as it is comparable to the standard of care in glycemic control and provides the additional benefit of lower hypoglycemia rates.”

AFREZZATM is a drug-device combination product, consisting of Inhalation Powder and a small, easy- to-use inhaler. Administered at the start of a meal, AFREZZA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the AFREZZA clinical program has involved more than 50 different studies and over 5,000 adult patients with both Type 1 and Type 2 diabetes.

MannKind is currently preparing its FDA resubmission of the AFREZZA new drug application and is hoping to gain approval for the treatment of adults with Type 1 or Type 2 diabetes.

Lady Gaga Knows Her Autoimmune Quotient – Do You Know Yours?

Over the last two weeks the Web has been abuzz with questions about Lady Gaga’s health. Turns out, we are informed, that she has a family history of lupus and has tested borderline positive for the disease.

The Lady Gaga story underlines an important message for millions of other Americans who have a history of autoimmune disease in their families. According to Virginia Ladd, President and Executive Director of the American Autoimmune Related Diseases Association (AARDA) “Lupus is one of more than 100 autoimmune diseases and these diseases cluster in families.  Having a family member with lupus could mean you are at increased risk for lupus and other autoimmune diseases.

That’s why it’s important, just as Lady Gaga has done, to know your family history, to inform your doctors, and take proactive steps to ensure your future health.

Evidence suggests that people need to take responsibility for their own autoimmune health. An AARDA study of autoimmune patients found that the average time for diagnosis of a serious autoimmune disease is 4.6 years. During that period, the patient typically has seen 4.8 doctors; and 46% of the patients were told initially that they were too concerned about their health or that they were chronic complainers.

One of the factors that makes getting a correct autoimmune disease diagnosis so difficult is that symptoms can vary widely, notably from one disease to another, but even within the same disease. The medical community’s lack of knowledge of autoimmune disease compounds the problem. Even though these diseases share a genetic background and tend to run in families, most health questionnaires at doctors’ offices do not ask whether there is a family history of autoimmune disease.

AARDA has devised an eight-step plan to help people increase their awareness of autoimmune diseases and calculate their Autoimmune Quotient (AQ):

1. Understand that autoimmune disease constitutes a major U.S. health crisis affecting 50 million Americans.

2. Get educated about the 100+ autoimmune diseases.

3. Be aware that autoimmune diseases target women 75% more often than men.

4. Know that autoimmune diseases run in families.

5. Do your own family medical history and inform your physician if you find that you have a history of autoimmune disease.

6. Keep a “symptoms” list if you believe you may have an autoimmune

7. Realize that getting an autoimmune disease diagnosis is often

8. Hold the power to protect your family’s future health and well-being
in your hands – be proactive about your health.

To find out more about autoimmune diseases, or how to calculate your AQ, visit the AARDA Web Site.

Stress at work increases the risk of asthma

A couple of weeks ago Word on Health reported that working too hard may be bad for your heart.  Now, there’s evidence that it’s also bad for your lungs!

According to a new study, employees who find it difficult to leave their problems at the office are much more likely to develop asthma. The research showed that having a stressful job can increase the risk of developing asthma by 40%.

Although most sufferers develop asthma in childhood, significant numbers are now diagnosed as adults. The research, from Heidelberg University in Germany, suggests stress at work could be one reason why. Researchers tracked 5,000 men and women, aged between 40 and 65, over eight years.

They found that among those free of asthma at the start of the project, there was up to a 40% higher incidence of asthma eight years later, if they suffered stress at work.

The signs were long working hours, demanding schedules and uncomfortable working conditions.

The report, detailed in Allergy, said: ‘Our study suggests work stress and the inability to relax after work are associated with an increased risk of asthma.’

Earlier studies have shown stress can lead to the release of chemicals that promote allergies and disrupt the way the body halts inflammation of the airways.

The team stressed that the absolute risk of someone developing asthma because they are overloaded at work is still very small.

Nevertheless, next time you’re asked to work late, you may want to stop and think of your health.

Drug Decisions

Hospital formularies identify the medications that can be used within a particular hospital. Which drugs are, and which drugs are not, available obviously have a significant impact on the quality and safety of patient care. As such, we would expect clinicians and pharmacists to utilize all available data when making decisions concerning medications for hospitalized patients.

Word on Health was therefore somewhat surprised by the results of a new survey just released by the Society of Hospital Medicine (SHM) and the American Society of Health-System Pharmacists (ASHP). According to their research, only 13% of formulary system decisions made by Pharmacy and Therapeutics (P&T) committees in hospitals are influenced by pharmacoeconomic data.

The survey of 319 directors of pharmacy or pharmacy practice managers evaluated the value of effects compared to the cost of pharmaceutical products when making decisions on changes to the formulary system.

In the study, 87% of respondents felt that pharamacoeconomic methods should be used when considering additions or deletions to their hospital formulary. However, when actually making formulary decisions, respondents reported that clinical and therapeutic factors contributed most to these decisions (54%), followed by drug costs (24%), and patient quality of life (9%).

Although, more than nine out of ten survey respondents reported having pharmacoeconomic analysis available during their most recent P&T committee discussion, only a quarter rated the available information as extremely helpful.

Pharmacoeconomics is all about balancing the costs of medications with the outcomes they provide and this survey pointed out that many P&T Committees underutilize this approach,” said SHM Chief Executive Officer, Laurence Wellikson.

The full report of the SHM-ASHP pharmacoeconomics survey can be found here.

SRxA and its team of specialized Health Outcomes  Advisors can help pharmaceutical companies collect and package pharmacoeconomic data in a meaningful and impactful way. Contact us today for further information.