A Safe, Happy and Healthy New Year from SRxA

New Year’s Eve.  A time to celebrate with dancing, drinking and delicious foods.

And while we hope our readers will enjoy the festivities, we want to ensure that the fun and frivolities don’t cause you or your loved ones injury.

So, our final Word on Health for the Year: eat, drink and be merry but keep these safety topics in mind:

• While festive drinks are fabulous, please drink responsibly. Let’s keep inebriated drivers off the roads. Organize your transportation plans ahead of time so you can enjoy yourself and arrive home safely.

• If you’re hosting a New Year party, remember although candles are beautiful they could potentially cause a fire. Make sure they are placed where they can’t be bumped and remember to blow them out before heading to bed.

• If you have young children or pets, you may want to forgo small whistles or plastic bells, which could cause a choking hazard.

• Dress warmly. Even if you aren’t joining the millions of people watching the ball drop outside in Times Square, in most parts of the country Dec. 31 2010, is going to be very very cold. Be prepared for situations like cars not starting, having to park a long distance away from the party or losing your keys. Have plenty of antifreeze and windshield wiper fluid on hand, and check your tire conditions before you leave the house. It’s a good idea to pack an emergency car kit, complete with tools, warm blankets, water, nonperishable food items, flashlights and cell phones, in case your car were to become stuck in a remote location.

So party safe and be sure to join us again in 2011 for all the latest news and views from the world of health, medicine and pharmaceuticals.

High hopes for long-term hemophilia B therapy

Investigators from St Jude Children’s Research Hospital and University College London recently announced extremely encouraging preliminary results of a Phase I/II gene therapy trial in patients with hemophilia B.

Hemophilia B, is a deficiency of Factor IX (FIX), one of the proteins necessary for normal clot formation. The disease affects about 1 in 30,000 people.  Without treatment, people with hemophilia B are at risk for uncontrolled, disabling and potentially fatal episodes of both internal and external bleeding.

The FIX gene is carried recessively on the X chromosome, and as a result the disorder, just like hemophilia A (FVIII deficiency), is almost exclusively seen in males, though it is carried by females.  Patients with severe hemophilia B, must normally inject themselves intravenously with FIX twice a week.

For such patients, gene therapy offers the enticing prospect of a near normal life, but previous studies have yielded disappointing results.

This study, presented last week at the American Society of Hematology annual meeting, was designed primarily to evaluate the toxicological safety study of low and intermediate doses. Because of the low dose used, researchers anticipated that trial subjects would produce little or no detectable FIX. So it was something of a positive surprise when the first patients FIX levels rose from <1% to 2% of normal, after infusion of the experimental vector.

While this rise, may not sound all that impressive, for a person with hemophilia it means the difference between severe and moderate disease.

Even more surprisingly, the patient’s FIX production remains elevated more than nine months later. Since the infusion the patient has also not suffered any spontaneous joint bleeds or needed prophylactic treatment.

Work on the vector began more than 10 years ago. An adeno-associated virus (AAV) vector known as AAV8 was picked because the incidence of natural infection with AAV8 is low and, like although it targets liver cells it does not integrate into the patient’s DNA. Participants received no immune suppressing drugs prior to infusion of the experimental vector.  The results so far suggest the experimental vector does not trigger the T-cell mediated immune response seen in a previous hemophilia B gene therapy trial.

The highest dose of the novel gene-vector combination is scheduled to be infused into the fifth and sixth study participants by mid-January. Investigators will then decide whether to expand the trial to include four more adults with severe hemophilia B.

As always SRxA’s Word on Health will be watching closely and will bring you news of further developments as they are announced.

2010: Not such a good year for Politics , Physicians, Patients and Pharma

2010 may be one of those years that many of us in the US want to forget. Chief among those hoping for a better year ahead will be politicians, physicians and the Pharma industry.

In view of the festive season we’ve decided to leave the political review of the past 12 months to the excellent political satirists at JibJab.  They entitled their remorseless, but as usual, stunningly accurate review of the year Duet of Regret.  Word on Health is delighted to re-gift this to you. Enjoy!

It’s been an equally bad year for doctors.  In late November, physicians learned that the reimbursement they receive for Medicare patients would drop by 23%  in December and a further 2% in January. These cuts are the latest installment of the 1997 Balanced Budget Act and attempts to rein in spending on health care for the elderly.

This is not only bad news for doctors, many of whose practices are largely composed of Medicare patients but also for the baby-boomer patients just turning 65 who may find themselves without a doctor.  Critics predict, some physicians will see Medicare patients  less frequently, while others will stop seeing them altogether.  Cynics have gone so far as to call this “elder cleansing.”

Now, to top of the year, a report from Public Citizen found that pharmaceutical companies top the list when it comes to defrauding the government. In fact , over the past decade, the pharma  industry accounted for 25% of all federal fines charged under the False Claims Act.

According to the analysis, drug-makers were the focus of 165 major settlements and have paid $19.8 billion in fines and settlements since 1991.  Three-quarters of these charges occurring over the past five years. GlaxoSmithKline, Pfizer, Eli Lilly, and Schering-Plough accounted for $10.5 billion of all financial penalties imposed over that period.

Pfizer holds the record for the largest criminal fine in United States history, $1.3 billion, and the largest health care fraud case, $2.3 from a settlement last year involving its marketing of the painkiller Bextra and other drugs.
Another company joined the violators  list just last week. Irish drug maker Elan announced that it had agreed to pay $203.5 million, half in criminal penalties, half in a civil payment, to settle an investigation of its illegal off-label marketing of the antiseizure medicine Zonegran.

While Word on Health sadly can’t fix politics or physician payments, SRxA can certainly help pharmaceutical companies stay out of trouble.  To find out how, make it your New Year’s Resolution list to contact us.

Happy Holidays

Whether you’re celebrating Advent, Chanukah, St. Nicholas Day, St. Lucia Day, Las Posadas, Winter Solstice, Christmas Eve, Christmas Day, Yule, Boxing Day, St. Stephen’s Day, Kwanzaa or the whole Twelve Days of Christmas… we at SRxA’s Word on Health, wish you Safe, Happy and Healthy Holidays.

If there are any holidays we’ve missed, we’re sorry; but drop us a note and we’ll be sure to include them next year.

Smoke Across the Water

While many people in the US are frustrated with healthcare reforms, SRxA’s Word on Health has learned that the grass isn’t always greener elsewhere.

This week, doctors in the UK have been told to stop referring smokers for any routine elective surgery unless their patients quit or complete a government run Stop Smoking course.

The controversial plans, which have already provoked anger among Family Practitioners, have been tabled as part of a draconian package of cost-cutting measures.

Other tactics include extending waiting times for surgery and a halt to all consultant-to-consultant referrals for the rest of the financial year unless clinically urgent.

Family doctors are also being asked to play a greater role in stopping their patients from going to the ER in order to drive down costs.

In a letter sent to all General Practitioners in the South West of England, the National Health Service (NHS) said: ‘There is good evidence to show that stopping smoking prior to surgery reduces length of stay and infection rates, and improves healing time; it is also a time when people are often highly motivated to give up. All patients who smoke and are booked for planned surgery will therefore be required to complete a NHS Stop Smoking course prior to surgery. Going forward, all patients requiring planned surgery should be referred to a NHS Stop Smoking Service before being added to the waiting list. A ‘Non Smoker’ status OR completion of the program is the threshold for surgical referral.’

Opponents of the scheme argue that this will only make waiting lists longer and denies smokers their basic human rights.

Word on Health would love to hear your views on this. Should patients be forced to give up smoking in order to have surgery?  Should smokers pay higher health insurance premiums because they consume higher amounts of healthcare costs?

Have your say now.

Top 10 Medical Innovations for 2011

Yes, it’s THAT time of year again.  Frenzied last minute preparation for the holidays means shopping and shopping means lists, lists and more lists.

Here’s one more list that we thought you wouldn’t mind us sharing. It comes from The Cleveland Clinic, one of the most respected healthcare institutions in the country, who recently released its Top 10 medical innovations for 2011.  The list includes groundbreaking drugs for cancer, hepatitis and multiple sclerosis, as well as technical innovations including incision-less bariatric surgery and pill sized cameras.

To be in the running for the Top 10 list, innovations had to meet the following criteria:

• Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery).
• Have a high probability of success
• Be on the market or close to being introduced
• Have sufficient data available to support its nomination.

So who made the list you ask?

With bated breath, a large drum roll and an annoying pause for a commercial break, here, in reverse order, dear Word on Health readers, are the winners for 2011:

10. Capsule endoscopy for diagnosis of pediatric GI disorders: A pill-sized camera that captures 50,000 high-resolution images during its painless six- to eight-hour journey through the digestive tract, proving better than x-ray at detecting small bowel ulcerations, polyps and areas of bleeding.

9. Oral disease-modifying treatment for multiple sclerosis: Before Fingolimod was approved by the FDA this year, MS drugs had to be injected or infused on a regular basis. This oral medication effectively stops T-cells from attacking the myelin sheaths that cover nerve fibers.

8. Exhaled nitric oxide (NO) breath analysis for diagnosing asthma: A new hand-held diagnostic testing device measures a patient’s level of exhaled NO, which is a biomarker for asthma. Monitoring NO levels allows doctors to more accurately tailor treatment strategies.

7. Transoral gastroplasty, or TOGA: A new experimental weight-loss option for obese patients who want to lose weight and improve their health without undergoing major surgery. This “scar-less” procedure represents a significant improvement in minimally-invasive bariatric surgery and losses approaching 40% of excess body weight can be expected within a year.

6. Telehealth monitoring for heart failure patients: Miniature implantable monitors to measure pulmonary artery pressure daily and at-home devices to monitor weight, heart rate and blood pressure of heart failure patients allow doctors to adjust medication quickly, improving patient outcomes and quality of life, while reducing re-hospitalizations.

5. Hepatitis C protease-inhibiting drugs: Two protease inhibitors drugs awaiting FDA approval for treatment of hepatitis C work by blocking a key enzyme that viruses need to copy themselves and proliferate. In clinical trials, cure rates for the protease inhibitors are higher than current hepatitis C treatments and have fewer side effects.

4. JUPITER study and statins for healthy individuals: The JUPITER (Justification for the Use of Statins in Primary Prevention: an Intervention Trial Evaluating Rosuvastatin) trial pointed out for the first time that many seemingly healthy people are at higher risk for heart disease than previously thought, suggesting that statins should be prescribed even to people with low LDL (bad cholesterol), if they have high C-reactive protein levels.

3. First therapeutic cancer vaccine approved by the FDA: While not a cure for prostate cancer, Sipuleucel-T is the first cancer vaccine to receive FDA approval. Prescribed to men with advanced prostate cancer, the drug coaxes their own immune systems into attacking and removing the cancer, reducing the risk of death by 24 percent compared to placebo.

2. Anti-CTLA-4 drug (ipilimumab), a targeted T-cell antibody for metastatic melanoma: The effectiveness of ipilimumab in treating melanoma confirms the role of immunotherapy as an effective treatment. In patients with advanced stage III or IV melanoma, 23% were still alive after two years compared to 14% of patients who received standard treatment.

1. New molecular imaging biomarker for early detection of Alzheimer’s disease: Currently, positive diagnosis of Alzheimer’s is only possible upon autopsy. But a radioactive molecular imaging compound called AV-45 and a PET scan can allow doctors to “see” inside patients’ brains to detect beta-amyloid plaques, the tell-tale signature of Alzheimer’s.

“If the technology is important to Cleveland Clinic it should be important to you,” said Christopher Coburn, Executive Director, Innovations, at the Cleveland Clinic.

Would these have been your picks?  SRxA’s Word on Health would like to hear from you.

Love and Other Problems

The new movie Love And Other Drugs, starring Anne Hathaway and Jake Gyllenhaal tells the tale of a pharma salesman who meets the love of his life at a doctor’s office.  The highly-paid hero is portrayed as a vain, flirtatious pushy rep who will stop at nothing to get doctors to write more scripts for his drug.   Armed with gifts, flowers and free lunches, he pitches his marketing message from office-to-office.

Clearly neither he nor the producers ever heard of the PhRMA code, OIG or the myriad of other pharmaceutical compliance governance.

And while it succeeds as a feel-good, romantic comedy, SRxA’s Word on Health suspects that it did little to help the reputation of the much maligned pharmaceutical industry.

A further nail in the coffin has just been delivered by Vanity Fair. In the January edition of the magazine, investigative reporters Donald Barlett and James Steele have penned a scathing attack on pharmaceutical companies in an article entitled Deadly Medicine.  In it, they dub the industry a “lethal profit machine.”

Unlike the movie, it’s not pretty.

They conclude: “In 2009, according to the Institute for Safe Medication Practices, 19,551 people died in the United States as a direct result of the prescription drugs they took. That’s just the reported number. It’s decidedly low, because it is estimated that only about 10 percent of such deaths are reported. Conservatively, then, the annual American death toll from prescription drugs considered “safe” can be put at around 200,000. That is three times the number of people who die every year from diabetes, four times the number who die from kidney disease. Overall, deaths from F.D.A.-approved prescription drugs dwarf the number of people who die from street drugs such as cocaine and heroin. They dwarf the number who die every year in automobile accidents. And with more and more of its activities moving overseas, the industry’s behavior will become more impenetrable, and more dangerous, than ever.”

For pharmaceutical companies, that’s one tough pill to swallow!

So…How can we change the perception that the industry is despicable and dangerous?

And…how can pharmaceutical companies regain trust and provide real value in their conversations with physicians and patients?

First, all sides of the debate need to acknowledge a few simple facts:

• Healthcare is a business – from the largest global pharma company to the smallest single doctor family practice.
• The pharmaceutical industry is not alone in wanting to sell its products and generate profits.  That’s what all businesses do
• Billions of dollars of these profits are reinvested in new drug development
• On average only 1:50 new drugs make it to market
• The average time to develop a new drug is 10 years and the cost around 1 billion dollars
• Human beings influence and are influenced by numerous factors / people everyday – it is called life.
• In order to control costs and treat patients effectively, everyone must work together.

Second, the relationship between the pharmaceutical industry and its critics needs to change. The current confrontational environment is a lose-lose situation. Pharmaceutical companies need to be perceived as bringing value to the healthcare equation and genuinely understanding what doctors and patients need.

Thirdly, and with apologies to Jake and 20^th Century Fox, the industry needs to kill the stereotype of the “goody” toting pharma rep and reinvent the role as one of collaborator, consultant, and educator.

SRxA can help companies manage these relationships and inject real value back into the mix.  To find out more, please contact us.

The Great Vitamin D Debate

Over the past decade there has been a lot of conflicting advice about the benefits of vitamin D and calcium.

Like many of our readers, this confusion has left us pondering: How much milk should we be drinking?  Are supplements really necessary? Can we get all the vitamin D we need from the sun?

We were therefore very interested to read the results of The Institute of Medicine’s (IOM) recently released review on dietary reference intakes for the vitamin D and calcium. Their latest recommendations were based on a review of more than 1,000 studies and reports as well as testimony from scientists and stakeholders. Interestingly, the IOM looked at a range of health outcomes, far beyond bone health.  These included, but were not limited to, cancer, cardiovascular disease, hypertension, diabetes, metabolic syndrome, falls, immune response, neuropsychological functioning, physi­cal performance, preeclampsia, and reproductive outcomes.

Although they acknowledged that both are important for health, overall, the committee concluded that the majority of Americans are receiving adequate amounts of both calcium and vita­min D.

Perhaps more interestingly, they warned that more than 2,000 mg of calcium per day increases the risk of kidney stones. Likewise, very high levels of vitamin D (above 10,000 IU per day) are known to cause kidney and tissue damage.

So at the risk of upsetting the vitamin industry, we’ve decided to save our money and our kidneys. From now on we’ll be getting our daily requirements of calcium and vitamin D by drinking milkshakes in the sun!

Twin Peaks

Peak flow readings help symptoms during the peak asthma season.

A new study from University of California San Francisco, has shown that a simple once-a-month peak flow test during the winter cold and flu season can improve symptom control in patients with asthma.

Researchers evaluated the impact of patients discussing their monthly peak flow readings with their doctors versus a control group who received standard care.

Significantly fewer patients in the intervention group:

• required oral steroids (9% v. 23%)
• had worsening symptoms  (65% v. 89%)
• needed urgent care visits (10% v. 23%)

Patients in the intervention group also had greater adherence to their inhaled steroids than those in the control group.

Study leader Professor Susan Janson concluded: “Interpreted peak flow monitoring may be beneficial to people with asthma during the seasons of greatest vulnerability.”

SRxA’s Clinical Advisors have pioneered a number of other unique programs to improve compliance with asthma therapy and improve health outcomes. Contact us today for more information.

Kiss and Tell?

About 300 years ago, the English author Alexander Pope famously wrote “To err is human, to forgive is divine.”

New research from the University of Illinois, Chicago concurs.  According to a study published in the November issue of Medical Care, people who believe their doctor or hospital would inform them if a medical error occurred are far more forgiving than those who doubt their health care provider would disclose the error.

A medical error is defined as a preventable adverse effect of care, whether or not it is evident or harmful to the patient. This might include an inaccurate or incomplete  diagnosis or treatment of a disease, injury or other ailment. Medical errors are one of the nation’s leading causes of death and injury and cost the US approximately $10 billion annually.  The Institute of Medicine estimates that as many as 300,000 patients are victims of medical errors, of which maybe as many as 200,000 people die.

In the new study, researchers surveyed a representative sample of Illinois residents regarding medical errors. About 40% of participants either had personal experience with medical errors, or had a close friend or family member who had been affected by an error.

Based on a hypothetical scenario, just 10% of survey respondents believed their physicians would be “very likely” to tell them if a medical error occurred. Yet, only a quarter said they would file a medical malpractice lawsuit if they were told about a medical error.

Respondents who trusted their doctor to disclose medical errors were no more (or less) likely to say they would sue. This was so even in a scenario where the health care provider offered to correct the problem through free additional medical treatment, and possibly a financial settlement.

However, people who trusted their health care provider to inform them about the error were more forgiving. Of the respondents who were most confident that their doctor or hospital would disclose the error, more than 60 percent said they would still recommend the provider, despite the error.

In contrast, only 30% of those who were skeptical about disclosure would continue to recommend the doctor or hospital.

The researchers found that although disclosure of medical errors is strongly preferred by patients, the most common policy is to “deny and defend” when errors occur because providers fear that it will trigger lawsuits and jeopardize their reputation.

The results show that patients perceived beliefs have a significant impact on their behavior. Patients who trust their providers to disclose errors may be no less likely to sue, but appear more likely to forgive. Conversely, patients who are most skeptical about disclosure may view their health care provider with “suspicion and frustration.”

Clearly when it comes to medical screw-ups, honesty is the best policy.