Good News for Pharma

According to the latest IMS figures, the pharmaceutical industry can expect annual growth of 5 -8 % over the next five years.

This equates to an increase of almost $300bn and means the global industry will be worth $1.1tn by 2014, despite the fact that 6 of the top 10 selling in the US will lose their patent protection between 2011 and 2012.

The report identified five key area market dynamics that would affect industry growth:

• The continued influence of emerging markets, including China and India
• Growth in therapy areas currently with unmet needs
• Publicly funded health systems under economic pressure to reduce growth in budgets
• Patent expiry’s on leading at similar times
• More rigorous and complex assessment and regulation of new products

IMS predicts that this latter trend will contribute to lower spending by payers and increase the time taken to launch products. The number of new molecular entities launched each year until 2014 is expected to remain at 30 – 35.

Murray Aitken, senior vice president of Healthcare Insight, said:  “Patient demand for pharmaceuticals will remain robust, despite the ongoing effects of the economic downturn being felt in many parts of the world.  In developed markets with publicly funded healthcare plans, pressure by payers to curb spending growth will only intensify, but that will be more than offset by the ongoing, rapid expansion of demand in emerging markets.”

 SRxA is on standby to help pharmaceutical and biotech companies maximize the opportunities and overcome the challenges presented by changing market dynamics.

Contact us for more information.

Putting an “i” in adherence!

Poor adherence to medications has been a bugaboo in the healthcare system for a long time. When sick patients don’t take their meds, they often get even sicker and end up in the hospital.  According to the New England Healthcare Institute, patients who don’t take their medicine when they’re supposed to cost the U.S. healthcare system a mind-boggling $290 billion per year.

This problem caught the attention of entrepreneurs from MIT and physicians affiliated with Harvard Medical School and has led to the creation of several innovative solutions. Among these is an electronic pill box called “Maya” that uses wireless technology and sensors to alert patients with chronic diseases when they don’t take their pills on time.

Another medication-reminder technology is GlowCaps.  These “intelligent” caps fit onto standard pill bottles and use light and sound to signal when it is time to take a pill. They also sense when the bottle is opened and wirelessly relay their status to a secure network. If the bottle is not opened after two hours, the user is automatically reminded with a telephone call.  Additionally, each week, a report summarizing progress is emailed to the user or care-giver. The caps can even call with refill reminders and connect the patient to their pharmacy as pills deplete.

Other solutions include iPhone apps such as MediMemory.

One company has even developed pills that deliver wireless signals after they are swallowed.

Even though such systems have shown to be effective, there’s still a question of who should pay for the technology. “The way that the economic models are currently set up,” says Joseph Kvedar, director of The Partners Healthcare Center for Connected Health , “it’s the patient’s responsibility to take their medication, and nobody will give them a cash subsidy to cover a program like this.”

Given that costs increase dramatically when patients don’t take their drugs, Word on Health suggests it’s about time insurers started paying attention to initiatives such as this.

In the meantime, SRxA’s Health Outcomes group are standing by to help pharmaceutical companies improve patient adherence to their drugs.  Contact SRxA for more information.

Nonprofits Calls on America to Expand Health Research

Policymakers and public health experts from across the globe gathered on Capitol Hill this week to call on the United States to bolster its commitment to fighting the deadly diseases that afflict the developing world.

Organized by the Global Health Technologies Coalition, the briefing featured a panel discussion in which participants explained how vaccines, drugs, diagnostics, and devices can catalyze improvements in a country’s health infrastructure. Panelists also examined how the U.S. can assure that residents of the developing world have a voice in the development and use of new health tools.

“Thanks to U.S. investment and innovation, undeniable progress has been made in preventing, diagnosing, and treating conditions like HIV/AIDS, malaria, tuberculosis, and other neglected tropical diseases,” said Jana Armstrong, Executive Director of the Drugs for Neglected Diseases initiative North America, “But the fight against infectious disease is by no means won. American leaders in both the public and private sectors must recommit to this fight.”

Word on Health agrees, but wonders why the pharmaceutical and biotech industry wasn’t invited to the party. The Global Business Coalition on HIV/AIDs, Malaria and Tuberculosis (GBC) was created to turn business assets into disease-fighting assets and has been pivotal in joining the corporate sector, governments and civil society together in common cause. Many pharmaceutical and biotech companies are members of GBC and have done outstanding work in this area. If you work for one of them, we’d love to hear from you.

Electronic Nose Sniffs Out Asthma

An artificial breath-sensor system dubbed the “electronic nose,” is able to accurately diagnose asthma, according to a study published in the April issue of the journal Chest.

The electronic nose detected nearly 90% of people with asthma compared to about 70% who were accurately diagnosed with lung function tests.

When combined with the fractional exhaled nitric oxide (FENO) test, the electronic nose did an even better job at detecting asthma.

The device works by identifying volatile organic compounds (VOCs) in exhaled breath. These VOCs produce a unique smell print for each individual and specific patterns are seen in people with asthma.

The study volunteers were tested by three different non-invasive methods: FENO, spirometry and the electronic nose.

The latter was able to correctly differentiate healthy people from those with physician-diagnosed asthma in 87.5% of the cases. FENO was able to correctly identify asthma in 79.2% of the study volunteers and spirometry discerned just 70.8 % of the people with asthma.

When the electronic nose and FENO were combined, the two tests together correctly identified almost 96% of the asthma cases.

Large studies are now required to definitively establish the diagnostic performance of the electronic nose.

Word on Health will continue to sniff out new information as it becomes available.

Better health care on offer but you’d better beat the crowd

Landmark health reforms will not only bring health care to the uninsured, they will bring more patients to doctors.  Lots more patients.  Forty-six million of them, all vying to find a Primary Care Physician (PCP).

In some parts of the country PCP’s are already in short supply, so the newly insured will be an extra strain on an already overstretched system.

Recently published reports predict a shortfall of roughly 40,000 PCP’s over the next decade. Not enough doctors are going into family medicine these days.  In fact, less than 30% of U.S. doctors practice primary care. The better pay, better hours and higher profile of other specialties are proving too much of a lure.

“It’s going to be harder to get appointments to see a physician” predicts Dr. Sam Benjamin, host of “Primary Care” on News/Talk 92-3 KTAR.

Provisions in the new health care bill aim to reverse this tide by offering bonus payments to those physicians prepared to expand community health services and offer them in areas where the greatest shortfalls exist.

The new law also puts emphasis on wellness care over sickness care, with policies that encourage physicians to try novel programs such as “patient-centered medical homes.”

Pilot tests of medical homes, through the American Academy of Family Physicians and Medicare, are under way around the country.  Initial results suggest they can improve quality but it’s not clear if they save money.

Only time will tell.

In the meantime, Word on Health welcomes your suggestions on how to solve the problem of too many patients and too few doctors.  Winning answers will be hand delivered to a large white building, just down the road.

21st Century Medicine promises new cures

More than 400 leaders in the field of regenerative medicine from across the world gathered last week in North Carolina at the 1st annual Translational Regenerative Medicine Forum.

Regenerative Medicine focuses on:

·         Medical devices and artificial organs

·        Tissue engineering and biomaterials

·         Cellular Therapies

·         Clinical Translation

The meeting covered best practices and business models to bring new therapies to patients Speakers also discussed the challenges of this emerging medical field, including obtaining funding. Robert N. Klein, of the California Institute for Regenerative Medicine, talked about that state’s successful referendum to fund stem cell research with state-issued bonds. He compared state investment in scientific research to investment in roads and other infrastructure. “We are used to funding physical capital. We have to realize that in the 21st century it is appropriate to fund intellectual capital.”

Andrew von Eschenbach, M.D., of the Center for Health Transformation, said that the promise of regenerative medicine demands a paradigm shift from treating disease to restoring health.

Although this may sound like a distant dream a lot of research is being undertaken.

“Regeneration is one of our top priorities,” said Alan Lewis, Ph.D., President and CEO of the Juvenile Diabetes Research Foundation International, “the organization has invested $60 million in the past few years on research to regenerate islet cells, the cells in the pancreas that produce insulin”.

Col. Janet R. Harris, Ph.D., M.S.N., from the U.S. Army Medical Research and Materiel Command, talked about a $85 million federally funded project to apply the science of regenerative medicine to battlefield injuries. “We’ve been very pleased with the progress we’re seeing,” she said. “Only two years into the grant, 13 clinical trials are being funded.”

Word on Health wonders which will come first, the Six Billion Dollar Man or the Bionic Woman?!?

We invite you to have your say.

Dumping Your Drugs

In honor of Earth Day Word on Health wants you to consider the environmental impact of unused medicines and commit to safe disposal practices.

In the past, Americans were taught that the safest way to dispose of expired and unused drugs is to flush them down the toilet.  However, there is now ample research to suggest that this may be the least environmentally friendly method.

In 2008 The Associated Press revealed that the drinking water of at least 41 million Americans contains minute concentrations of multitudes of drugs including antibiotics, anti-convulsants, mood stabilizers and sex hormones.

There’s growing concern in the scientific community, that certain drugs or combinations of drugs may harm humans over decades because water, unlike most specific foods, is consumed in sizable amounts every day.

While our bodies may shrug off a relatively big one-time dose, yet suffer from a smaller amount delivered continuously over a half century, perhaps subtly stirring allergies or nerve damage. Pregnant women, the elderly and the very ill might be more sensitive.

Recent laboratory research has found that even small amounts of medication have affected human embryonic kidney cells, human blood cells and human breast cancer cells. The cancer cells proliferated too quickly; the kidney cells grew too slowly; and the blood cells showed biological activity associated with inflammation. Furthermore, chemotherapy drugs can act as powerful poisons; hormones can hamper reproduction; medicines for depression and epilepsy can damage the brain or change behavior; antibiotics can enable germs to mutate superbugs.

In addition to the health risk for humans, these drugs have a dramatic effect on wildlife. Pharmaceuticals cause severe reproductive problems in many types of fish. The endangered razorback sucker and male fathead minnow have been found with lower sperm counts and damaged sperm, while some walleyes, male carp, and some frogs have taken on female traits. Even earthworms are affected.

Solving the problem is not so easy.  People take pills. Their bodies absorb some of the medication, but the rest of it passes through and is flushed down the toilet. The wastewater is treated before it is discharged into reservoirs, rivers or lakes but most treatments do not remove all drug residues.

“People think that if they take a medication, their body absorbs it and it disappears, but of course that’s not the case,” said Environmental Protection Agency scientist Christian Daughton, one of the first to draw attention to the issue of pharmaceuticals in water.

Even so, safe disposal of unused, expired and discarded medicines can help.

The  FDA recommend that most unneeded pharmaceuticals be placed in a sealed zip-lock bag with some substance like coffee grounds or kitty litter, that will make them unattractive to animals, children or anybody who might go through your trash.

Hazardous pharmaceutical waste such as anti-cancer agents should be incinerated or returned to the manufacturer through a reverse distribution program. Earth 911 lists pharmacies and other drop-off places that will safely recycle unwanted medicines.

If your company offers a reverse distribution program we’d love to hear from you.

New Use Identified for Birth Deformity Drug

According to a study just published in Nature Medicine, thalidomide, a drug found to cause birth defects when it was launched as a morning sickness pill half a century ago, may be useful for treating a condition that affects blood vessels.

French researchers found giving thalidomide to patients with hereditary hemorrhagic telangiectasia (HHT) reduced the severity and frequency of nosebleeds, one of the main symptoms.

HHT affects about one in 5,000 people. Many patients develop recurrent, difficult-to-treat nosebleeds which can significantly harm their quality of life.

Researchers from the National Institute for Health and Medical Research (INSERM) in Paris, said experiments on mice with HHT showed that thalidomide treatment increased platelet-derived growth factor-B (PDGF-B) expression in endothelial cells and appeared to repair blood vessel walls.  Additionally, biopsies of the nasal surface tissue from patients with HHT suggested that similar mechanisms may explain the effects of thalidomide treatment in humans.

Thalidomide was sold as a treatment for morning sickness between 1957 and 1961 until it was found that pregnant women who took the drug for morning sickness were at high risk of having a child with severe congenital defects, notably missing or stunted limbs.

The drug was taken off the market, but more than 10,000 babies, especially in Germany, Britain, Australia and Canada, were affected.

The scandal led to a tightening of the approval procedures for new drugs in several countries, including the US.
Although thalidomide remains outlawed for general distribution, in recent years, it has experienced a revival, being used under very tightly-controlled conditions to treat certain forms of cancer such as multiple myeloma and side-effects from leprosy.

Word on Health wonders how many more uses will be found for this drug that was once considered so disastrous.

Prozac Pilots take to the Happy Skies

Flying in the US just got a whole lot easier…at least for pilots!

The US Federal Aviation Administration (FAA) has lifted a 70 year old rule that banned pilots from taking antidepressants because of the risks of sedation. The ban had endured because earlier generations of antidepressants caused side effects, such as drowsiness and seizures.  However, a panel of medical experts for the FAA found during two years of research that newer versions don’t cause side effects in everyone. When they do occur, they tend to subside over time.

This policy turnaround means that pilots taking selective serotonin reuptake inhibitors (SSRIs), including fluoxetine (Prozac), sertraline (Zoloft) citalopram (Celexa) and escitalopram (Lexapro) or their generic equivalents and who show success controlling their depression for 12 months, without side effects that could pose a safety hazard in the cockpit, will be able to seek permission to fly.

This rule change may benefit up to 10,000 grounded pilots.  It also includes a degree of amnesty for pilots who have lied about their diagnosis and treatment on medical certification forms. Previously, airline and other pilots who suspected they were depressed but wanted or financially needed to fly faced a choice: seek no medication for treatment, because doing so would disqualify them, or self-medicate and lie about it on a required medical certification form.

The National Institute of Mental Health estimates that about 9.5 percent of people 18 and older suffer from a mood disorder. A 2009 study by Columbia University showed that as many as 10% of Americans were taking antidepressants. FAA officials assume the percentage is about the same among pilots but has no hard numbers because the ban gave pilots a disincentive to report depression or treatment.

”We need to change the culture and remove the stigma associated with depression,” said an FAA official. ”Pilots should be able to get the medical treatment they need so they can safely perform their duties.”

SRxA’s Word on Health wonders if this will mean fewer delayed flights or more happy flight crews. What do you think?

The voice of asthma

If you have been diagnosed as having asthma, but are not responding to medications, the wheezing could be due to something entirely different.  Many people who have been treated, often unsuccessfully, for asthma have been found to have vocal cord dysfunction (VCD) instead.

So what is VCD?

Normally when an individual breathes in or out the vocal cords are drawn apart by the muscles of the larynx to make a wider opening for air to move into or out of the lungs. In an individual with VCD, the vocal cords move together, instead of being drawn apart, resulting in a narrowing and partial blockage of the airway. As a result of the narrowed airways, the individual may cough, wheeze, feel short of breath, or make a high-pitched, harsh sound (stridor) with each breath.

Signs of VCD include:

• Difficulty when breathing in
• Wheezing occurring almost immediately after exercise
• Wheezing that does not respond to bronchodilators

If this strikes a chord, you may need to be evaluated by an ear, nose and throat specialist, (ENT) who can diagnose VCD with a number of simple tests.

Most patients with VCD do not need medicines, but can be helped by speech therapy techniques such as vocal cord relaxation techniques and breathing exercises. For some cases of acute VCS, helium-oxygen therapy may be prescribed. The helium-oxygen mixture (heliox) is less dense and more oxygen-rich than regular air, so it is easier to inhale.

Word on Health suggests if your asthma is not being relieved by asthma medications you may need to be more vocal in seeking treatment.

Remember, even if it sounds like asthma and feels like asthma, it might not be asthma!