Pharma – Cracking Down on Crime

It’s rare in the pharmaceutical industry when a drop in numbers is a sign of good news. Unless it’s fewer side effects, most industry insiders cringe when they hear that this year’s figures are lower than last.

However, SRxA’s Word on Health brings you news of a downward trend that should please all but the most criminal elements of society.

A new report from Freightwatch International shows that the number of thefts of pharmaceuticals significantly declined over the past 12 months.  Not only were there fewer incidents, the average value of each theft was lower.  In total, there were 36 thefts involving shipments during 2011, compared to 49 in 2010. And the average value of lost shipments was $585,000, down dramatically from $3.78 million the year before. Trailer thefts accounted for approximately 90% of the heists. Deceptive pickups and burglaries from warehouses made up the remainder.

This was the first year on record that the pharmaceutical industry did not have the highest value per theft incident. That distinction went to the electronics industry, where the most targeted items were televisions, consumer electronics and cell phones.

Significantly, there were just two pharmaceutical thefts valued at more than $1 million last year. In previous years, the average loss per pharmaceutical theft averaged between $3.5 million and $4 million. Two years ago, medicines worth up to $75 million were stolen from an Eli Lilly distribution center in Connecticut after robbers broke in by cutting a hole in the roof.  That incident resulted in national headlines and prompted the drugmakers  to improve security efforts and tighten the supply chain. Organizations such as the Pharmaceutical Cargo Security Coalition are now dedicated to preventing the theft of medicines in transit.

Nevertheless, pharmaceutical supply chain issues remain a hot topic.

RxPatrol is an initiative designed to collect, collate, analyze and disseminate pharmacy theft intelligence to law enforcement agencies nationwide.

The FDA is also concerned about protecting consumers from the threat of stolen, counterfeit, and diverted prescription and over-the-counter medicines. Stolen products may put consumers at risk because they may not have been stored or handled properly or may have been tampered with while out of the normal supply chain.  An FDA website lists all thefts involving FDA-regulated products that have been stolen either from warehouses or tractor-trailers, and encourages the public to report any suspected criminal activity.

Earlier this month, the US Pharmacopeial Convention (USP) published its proposed general chapter on good distribution practices to ensure pharmaceutical supply chain integrity, for comment in advance of its upcoming workshop due to be held in May 2012.  The aim of the workshop will be to develop best practices to combat counterfeit active pharmaceutical ingredients, excipients, drug products and medical devices that are imported into the USA.

And that can only be a good thing. One of the most harrowing books I ever read was Dangerous Doses by investigative journalist Katherine Eban. In it she exposes a world of criminal activity and corruption and how an increasing number of Americans get counterfeit medicines instead of the real thing.

And while pharmaceutical thefts have not gone away, they are on the decline. For that we must be grateful this Monday morning.

Oh S**t! – Don’t Try This At Home

In the mood for a little DIY this weekend?  Paint the bathroom…put up a few shelves…perform a poop transplant???

Regular Word on Health readers will recall that last year we brought you news of a successful, yet controversial, new treatment for inflammatory bowel disease – fecal microbiota transplantation. While we remembered to warn you of the “yuck factor” associated with this post, we never thought to add the caution “don’t try this at home.”

Seems we should have.

Lately, stories about the success of at-home fecal transplants have been spreading virally, or should we say bacterially, across the internet!  Stranger still, some respected science writers  and researchers have expressed support for the procedure. People are literally buzzing about the possibilities.

Dr. Lawrence Brandt, head of gastroenterology at Montefiore Medical Center in the Bronx, says that he receives several emails a week from people begging for fecal transplants. While they used to come only from people suffering from bowel disease, now he’s getting requests from people who are hoping to beat diabetes, autism, asthma, MS and obesity too.

As it’s not clear whether gut bacteria can help with any of these complaints, many doctors are unwilling or unable to help.

And that’s why, it seems, patients are now doing it themselves.

Chris Gorski is one such person prepared to take this drastic step. Last year, his daughter developed a gut infection that caused severe and chronic diarrhea. Despite antibiotics, she still has symptoms and now Gorski worries that the infection will destroy the lining of her intestines and affect her for the rest of her life.  Armed with what he’s read on the internet, and a burning desire to help his daughter, he’s decided to collect some of his own stool, strain it, and then squirt it into her body using colonoscopy instruments.

He hopes that his “good bacteria” will become established in the girl’s body and repair her gastrointestinal tract.

Gorski’s plan may sound gross, but he argues that what he’s doing is revolutionary. In an age when probiotics, are being extolled for their beneficial qualities, he says his solution is just an extension of living medicine.

Do you think this is a good idea, or how shall we say it, just a crappy one?!?  Let us know what you think.

Syphilis Sets Sail

SRxA’s Word on Health has heard that history may about to be rewritten.  According to researchers at Emory University, not only did Christopher Columbus discover the New World, he also brought back one of the world’s most feared diseases.

A new review of the origin of syphilis supports the theory that the sexually transmitted disease was carried to Europe aboard Christopher Columbus’ ships.

Syphilis has been around for 500 years,” says study co-leader Molly Zuckerman, assistant professor at Mississippi State University. “People started debating where it came from shortly afterwards, and they haven’t stopped since.

Although syphilis was one of the first global diseases, understanding where it came from and how it spread may help us combat diseases today. Prior to Columbus’ voyage in 1492, syphilis did not exist in Europe or the Old World.

After analyzing the evidence from 54 reports, the team from Emory found that before Columbus’ historic voyage to the New World, skeletal material lacked the diagnostic characteristics for chronic syphilis, such as small holes in the skull and long bones.

Their appraisal, published in the Yearbook of Physical Anthropology, suggests that someone sailing with Columbus carried Treponema – the bacteria that causes syphilis back to Europe. Treponema can cause other diseases, such as yaws and pinta, that are spread through skin-to-skin or oral contact in tropical climates.

Their theory is that the bacteria mutated into the sexually transmitted form to survive in the cooler and more sanitary conditions of Europe.

In reality, it appears that venereal syphilis was the byproduct of two different populations meeting and exchanging a pathogen,” Zuckerman said. “It was an adaptive event, the natural selection of a disease, independent of morality or blame.”

That said, we’re still blaming Columbus!

A Record Year for the FDA

Regulators have taken much of the blame for the drug industry’s monumental problems, especially their inability to bring new products to market, leaving the US lagging behind many other countries. Now the FDA is fighting back.  The Agency just announced that it green-lighted 30 new drugs in 2011 – a 7-year high.  Among these, Johnson & Johnson  and GlaxoSmithKline received approval for three new drugs each.  FDA Commissioner Margaret Hamburg also noted that it had been the first regulatory authority worldwide to give the nod to a number of novel treatments including  as Seattle Genetics lymphoma drug Adcetris. One possible reason for the increase in new drug approvals was the Agency’s willingness to meet with pharmaceutical companies before data were submitted.  Another may be the industry’s focus on submitting better data, particularly in regard to drug safety.  “I think people have realized that FDA has gotten more difficult and they’re improving what they turn in,” says Citigroup analyst Yaron Werber. Even so, the pharma industry is expecting some tough years ahead with increased generic competition for many of the top-selling drugs. And it remains to be seen whether the industry and the FDA can stay with the 2011 pace for approvals or whether they will sink back to the low numbers experienced in years past.

Treading Lightly – A New Approach for Pharma

Last week, the Wall Street Journal reported on a dramatic change occurring in the pharmaceutical industry. The on-line article explored how many of the big pharma companies are changing their commercial model in response to the current economic and regulatory conditions. Most notably, drug reps are being encouraged to soften their sales pitches and re-position themselves as a trusted resource for the doctors they call upon. British drug giant GlaxoSmithKline (GSK) for example, has stopped evaluating salespeople based on the number of prescriptions written  Instead, they look at how well physicians rate their representatives. GSK, Merck and Lilly are also asking their representatives to switch from making forceful, tightly scripted sales pitches to acting more like a resource supporting physicians’ treatment. Companies hope to get a foot in the door by providing practical help, such as assistance educating patients about their diseases or navigating reimbursement. Why now?  Clearly, prescribers, who are under increasing pressure from health plans to curb costs, have less time for, and patience with, persistent sales representatives. Plus, the government has been cracking down on aggressive, and off-label marketing. For some, myself included, this is nothing new. Almost 20 years ago when I worked in pharma, I rarely “detailed” my products. Instead, I helped “my doctors” build websites for their own practices, helped to organize, and on occasions even moderate, their clinical meetings and assisted them with….well just about anything they wanted assistance with, be it product related or not. The strategy worked, sales grew and my competitors, even those with better products or prices were neutralized. Increasing physician satisfaction, it turns out, is a much better way to promote a pharmaceutical agent than simply telling them to write more prescriptions or what the benefits are,” says David Ricks, president of Lilly’s global business unit. Unfortunately, salespeople still can’t provide the one thing many doctors want above all – time!  Even though pharmaceutical companies are attempting to engage prescribers in a more pleasant way, they still don’t always get a positive reception because nothing is being done to solve the doctors’ time problem. The bottom line is that physicians need to fit more patients – not sales reps – into their workday. Although it’s estimated that pharma sales reps  pay 115 million visits to 340,000 doctors each year, 23% of doctors surveyed by market research firm SK&A in 2010 said they don’t see drug reps at all. Eli Lilly decided to adopt its new approach after watching launches of new drugs fail. One problem the company identified was a mismatch between what doctors expected based on sales pitches, and what the products delivered. Before the change in tactics, psychiatrist Carey Cottle, MD says he was more likely to write prescriptions for a competing antidepressant like Pfizer’s  Effexor over Cymbalta, because Lilly representatives had a “high-pressure, car sales-type approach, and it was just not appropriate.” Now, surveys of doctors show that 85% are satisfied with Lilly, up from the 60% before the company changed ways. And business is up too. Sales of Cymbalta were >$450 million higher during the first nine months of 2011, than during the same period in 2010. We’d love to hear what doctors and sales reps think about this.

False and Misleading or Just Messy?

When it comes to marketing and promotion, most pharmaceutical companies play by the FDA rules. Violations result in Warning Letters. And Warning Letters are not good. Period.

To avoid such violations, drug companies have introduced promotional review committees and other measures to keep marketers on the straight and narrow.   Additionally, they’ve hired Compliance Officers, regulatory staff and legal counsel.  Now it seems, pharma may have to add house-keeping to the mix!

Last summer, NeurogesX, a San Francisco-based biopharmaceutical company exhibited at the American Academy of Nurse Practitioners meeting in Las Vegas to promote Qutenza  – a capcaisin treatment for neuropathic pain associated with postherpetic neuralgia; a condition that occurs as a result of nerve damage after an outbreak of shingles.

The NeurogesX exhibit included an eye-catching promotional panel for Qutenza featuring a polar bear. The panel made various effectiveness claims, and included all the risk and safety claims required by the FDA.  So, what’s the problem?

Well, according to a Warning Letter sent to the company the risk information was inaccessible to those who stopped or walked by because it was obscured by bags, boxes and other stuff! As a result, the FDA deemed the entire booth to be false or misleading.

How did the FDA know? Well, apparently three different personnel from the FDA Office of Prescription Drug Promotion, visited the booth separately at three different times, meaning this was not a one-off occurrence.

So, was this a simple case of carelessness or was NeurogesX trying to hide the risk information? I’m not sure we’ll ever know the truth, but it’s clear the FDA is “cleaning house” – one exhibit booth at a time.

Was the Agency justified?  If they really care about safety why didn’t they say something at the time, rather than let the boxes obscure the data throughout the show?  Let us know what you think.

Happy Anniversary

SRxA’s Word on Health is celebrating another milestone today – our 2nd Anniversary.

Seems like only yesterday we were wondering If MLK had lived – would he have had asthma?

In the intervening time we have posted 320 blogs on 175 different topics.

And it seems you like them. The number of subscribers and Word on Health readers has grown exponentially.

A year ago we were pleased to report a total of 14,697 views. This year, that number is >90,000.

In 2012 we’d like to hear more from you and to bring you more of the stories you’re interested in. So we’ve also revamped the site to make it easier for you to comment – so let us know what you think of our new look.
Tell us what’s on your mind, tell your friends about us. We look forward to reporting even higher numbers next year.

In the meantime, from the entire SRxA team we’d like to say a huge THANK YOU to everyone who has supported us.

Musing on MLK

Today, many Americans will be enjoying a day off work in observance of Martin Luther King.  Among these, some will be occupied in the annual tradition of trying to guess what the good Doctor would have said about current health issues if he was still alive today.

What Martin Luther King would have thought about President Obama’s health care reform requirement that all Americans buy health care insurance?

Sarah Palin wrote that, “He fought for liberty and equality because he knew they were God-given and he knew that no government should be empowered to thwart our freedom.”  The implication, being that King would have been against health care reform because it would be a blow to freedom.

Others have complained that the bills don’t go far enough towards King’s vision of equality.  They point out that millions will remain uninsured. Expensive health plans could hurt middle class workers, and the subsidies don’t go far enough towards helping poor families.  They are probably right to a certain extent – King would have pushed for a bill that did more to help poor and working families, and a bill that covered everyone.

So what do we think? Certainly Dr King would have wanted to see improved access to care for minority populations.

Health disparities are well documented in minority populations such as African AmericansNative AmericansAsian Americans, and Latinos. When compared to European Americans, minority groups have higher incidence of chronic diseases, higher mortality, and poorer health outcomes. Minorities also have higher rates of cardiovascular diseaseHIV/AIDS, and infant mortality than whites.  Additionally:

  • African Americans have higher rates of mortality than any other racial or ethnic group for 8 of the top 10 causes of death. For example, the cancer incidence rate among African Americans is 10% higher than among European Americans.
  • U.S. Latinos have higher rates of death from diabetes, liver disease, and infectious diseases than do non-Latinos.
  • Adult African Americans and Latinos have approximately twice the risk as European Americans of developing diabetes.
  • Native Americans suffer from higher rates of diabetes, tuberculosis, pneumonia, influenza, and alcoholism than does the rest of the U.S. population.

In some cases these inequalities are a result of income and a lack of health insurance.. Almost two-thirds of Hispanic adults aged 19 to 64 were uninsured at some point during the past year, a rate more than triple that of working-age white adults. One-third of working-age black were also uninsured or experienced a gap in coverage during the year. Compared with white women, black women are twice as likely and Hispanic women are nearly three times as likely to be uninsured.

A patients’ race also influences physician prescribing. Numerous studies have found racial differences in prescribing and treatment patterns for hypertension, hypercholesterolemia, cancer, pneumonia and diabetes.

Race has played a major role in shaping systems of medical care in the United States. The divided health system persists, in spite of federal efforts to end it. We hope that those in a position to change such inequalities take today, to reflect how such change can be implemented.

Be S.A.F.E.

SRxA’s Word on Health was deeply saddened to hear of the seven-year-old girl from Chesterfield County, Virginia who died this week after suffering an allergic reaction at school.  According to news reports she was given a peanut from another child who was unaware of her allergy.

Our heartfelt condolences go out to her family and friends. We dedicate this blog as a tribute to her and all the other children who have lost their lives to anaphylaxis.

Although there’s no cure for food allergies, as we’ve reported in the past, such deaths are almost entirely preventable with proper education and immediate treatment with epinephrine.   And even though we don’t know all the details of this case, what we do know is that food allergies are on the rise. 8% of children under age 18 in the United States have at least one food allergy.

Now, we’d like your help to prevent a similar tragedy from happening in the future.

The American Academy of Allergy, Asthma and Immunology’s  Be S.A.F.E. campaign is dedicated to educating patients and healthcare professionals on the steps needed to save lives. We urge you to read the campain’s action guide and share it with your colleagues, friends, and relatives. If you have kids in school, make sure the teachers are aware of it. If you use a gym, make sure the trainers know. Tell your favorite restaurant, share with your employer…the list goes on and on.

BE SAFE

Seek immediate medical help. Call 911 and get to the nearest emergency facility at the first sign of anaphylaxis, even if you have already administered epinephrine.

Identify the Allergen. Think about what you might have eaten or come in contact with – food, insect sting, medication, latex – to trigger an allergic reaction. It is particularly important to identify the cause because the best way to prevent anaphylaxis is to avoid its trigger.

Follow up with a Specialist. Ask your doctor for a referral to an allergist/immunologist, a physician who specializes in treating asthma and allergies. It is important that you consult an allergist for testing, diagnosis and ongoing management of your allergic disease.

Carry Epinephrine for emergencies. If you are at risk for anaphylaxis, make sure that you carry an epinephrine kit with you at all times, and that family and friends know of your condition, your triggers and how to use epinephrine. Consider wearing an emergency medical bracelet or necklace identifying yourself as a person at risk of anaphylaxis. Teachers and other caregivers should be informed of children who are at risk for anaphylaxis and know what to do in an allergic emergency.

So there you have it. 4 simple steps that could save lives. Go share them!

Kicking Up A (cytokine) Storm

The New Year brings with it many new possibilities, including, unfortunately a new flu season.

So far, the number of flu cases in 2012 is down, thanks largely to the unprecedented mild weather over most of the US. A sharp contrast to 2009 when H1N1 (or swine flu) killed more than 18,000 people worldwide or 1918 when the flu virus infected around a third of the world’s population and killed at least 50 million people.

New research shows that the reason so many people died in both of those years wasn’t the influenza virus itself, but the immune system’s reaction to it.  It turns out that the virus destroys its host by turning the body’s own defenses against itself.

While trying to destroy flu-infected cells, your immune system also destroys legions of perfectly healthy cells all over your body. This is why, even though the virus itself rarely ventures outside the lungs, the symptoms of the flu are so widespread” says , Michael Oldstone, a virologist at the Scripps Research Institute in La Jolla, Calif.

Most of the time this immune response isn’t too severe. As the virus runs its course, the response subsides. But in some cases, an infection can trigger a reaction so destructive it can be fatal. Scientists call this a cytokine storm, because of the violent way immune cells respond to a virus. Cytokines usually help fight off infections by telling the immune system which specific viral cells it should be attacking, but sometimes an overabundance of cytokines floods into a part of the body, and that’s when you get a storm.

Cytokine storms are rare, but they may be more common among younger people because they have stronger immune systems, and are more prone to overreactions. This may explain one of the more surprising outcomes of the 2009 swine flu: that it was deadlier among young people than it was among the elderly.

Cytokine storms can cause serious damage throughout the body, especially in the lungs, which is why most flu deaths are attributed to pneumonia.

After 5 years of research, Oldstone and his colleagues have identified a cell — they call S1P1 – that responds to cytokines. More importantly they’ve also figured out how to turn off that cell’s signals. This could pave the way for a new class of immune-reaction-blocking drugs that could provide protection against cytokine storms and be more effective than antiviral drugs.

Cytokine-blocking drugs could target the flu effects that cause the most damage to the body and would avoid the problems of virus mutation because they don’t affect the virus itself.

Still, it will probably be many years before those drugs reach your local pharmacy. Although preliminary experiments in mice have shown very promising results they still have to replicate these in ferrets, then primates and finally, humans.

Do you have any flu stories to share? SRxA’s Word on Health would love to hear from you.