Olympic Spirit?

As over 10,000 athletes from all over the world gather in London for the Games of the XXX Olympiad – better known as the 2012 Summer Olympic Games, and as spectators witness the amazing displays of athleticism,  SRxA’s Word on Health has been looking at the unhealthy history of the modern games.

Yes, today we’re talking doping.  The use of performance enhancing drugs has had a long history at the Olympic Games. Its origins can even be traced back to the Ancient Olympics. Athletes were also known to drink “magic” potions and eat exotic meats, such as lizard, to try and gain an athletic edge on their competition.

Back then, men were required to compete naked…but that’s a different story!

In the modern Olympic era, chemically enhancing one’s performance has evolved into a sophisticated science, but in the early years of the Modern Olympic movement the use of performance enhancing drugs was almost as crude as its ancient predecessors.

At the 1904 games in St Louis, Thomas Hicks, the winner of the men’s marathon was given  strychnine, eggs and brandy, before and even during the race.

This early example of “doping” certainly wasn’t the last. In 1957 a New England Journal of Medicine editorial commented on the dramatic improvements in performance at track and field events. The editorial considered the possible reasons for the recent epidemic of broken records.  It suggested that although training, diet antibiotics and motivation played a role, amphetamine use by athletes may be the main reason that otherwise unassailable records were being broken.

Performance enhancing drugs are not only a threat to the integrity of sport but can also have potentially fatal side effects. During a cycling event at the Rome Games of 1960, Danish cyclist Knud Enemark Jensen fell from his bicycle and later died. A coroner’s inquiry found that he was under the influence of amphetamines, which had caused him to lose consciousness during the race.

By the mid 1960s, sports federations were starting to ban the use of performance enhancing drugs, and the International Olympic Committee followed suit in 1967.

Despite this, each passing decade since has brought new scandals, new performance enhancing drugs, new testing methods and new methods to evade testing.

In 1984, the US Olympic Committee admitted that seven of its cyclists had received blood transfusions. Four years later, Canadian sprinter Ben Johnson was stripped of his gold medal from the Seoul Olympics when his urine samples were found to contain the anabolic steroid stanozolol.

Next came erythropoietin (EPO). The 1992 Games in Barcelona were even nicknamed the “Hematocrit Olympics.”

At the 2008 Games in Beijing the official slogan was “Zero Tolerance for Doping” . Even so, six athletes with positive specimens were ousted from the competition. Although this was far fewer than at previous games, it can’t be concluded that the prevalence of doping decreased as doping technology has become more sophisticated and athletes have turned to drugs that can’t be detected.

The list of drugs banned from the Olympicsis determined by the World Anti-Doping Agency. The banned substances and techniques include: androgens, blood doping, peptide hormones, stimulants, diuretics, narcotics, and cannabinoids.

Both experts and cynics are already asking, will future athletes turn to gene therapy…or have they already started? One thing’s for sure, the Olympics will remain an object of fascination for all the right and the wrong reasons.

Egging on Allergies?

Friends, family, colleagues and regular readers of SRxA’s Word on Health already know about my egg allergy.  What they may not know about is my egg aversion.  Just typing the “e” word makes me queasy.  Thinking about eggs makes me cringe and actually seeing them, especially hard boiled, fills me with revulsion.

So, with some trepidation, I bring you this breaking health story.

According to a study just published in the New England Journal of Medicine by giving children with egg allergies increasingly higher doses of the very food they are allergic to researchers found they could eliminate or ease reactions in most of them.

The study conducted at Johns Hopkins Children’s Center and four other U.S. institutions treated 40 egg allergic children with escalating doses of eggs – an approach known as oral immunotherapy.

In the 10 month study, 40 children, aged 5 -18, received escalating doses of egg-white powder while 15 received a cornstarch placebo.  35 of the 40 children treated with egg immunotherapy experienced improvement. Five dropped out of the study, four of them due to allergic reactions. Eleven of the 35 patients experienced complete long-term elimination of egg-related allergic reactions. The rest of the children were able to tolerate higher doses of egg with only mild or no symptoms.

“More than a quarter of the children in our study lost their egg allergies altogether, but we also saw dramatic improvements in those who didn’t, which in and of itself is an important therapeutic achievement,” says Robert Wood, M.D, director of allergy and immunology at Johns Hopkins Children’s Center. “These children went from having serious allergic reactions after a single bite of an egg-containing cookie to consuming eggs with minimal or no symptoms.”

This is important because it can protect against serious allergic reactions from accidental or incidental exposures and give patients and parents a peace of mind at restaurants, parties and other venues where food control is difficult or impossible.

But while this may be good news for the estimated 3% of U.S. with egg allergies, this blogger is not so sure she’d be a candidate.  The thought of having to eat escalating doses of the dreaded “e” word is more abhorrent to me than the thought of a future filled with quiche and ice cream!

On a more serious note, we’d also like to brings readers some sage advice from allergist David Amrol MD : “Although oral immunotherapy is our best chance for a food allergy cure, it is not ready for mainstream use until protocols are further refined. Patients who are not enrolled in clinical trials must continue to rely on allergen avoidance, patient education, and self-injectable epinephrine.”

Reckless Research Race, Results in Rising Retractions. Reform Required?

As our regular readers know, SRxA’s Word on Health loves nothing more than a good alliteration to start the day!  Although the blog post title may rank as one of our more classic tongue twisters, there is nothing amusing about the content.  As involved as we are in medical communications and peer-reviewed, scientific publishing, we are saddened to report on the rise of a recent trend of falsified research. An unsettling pattern is emerging. The rate at which articles are retracted (meaning the study was published, only to later be dubbed unfit for print — typically due to either deliberate misconduct or an honest scientific mistake) is increasing. To our knowledge, at least three scientific journals have published articles over the past two years warning of the rise in retractions and misconduct by researchers who have fudged results.

Last year Nature reported a tenfold increase in retractions over the past decade even though the number of published papers only increased by 44%. Before that, the Journal of Medical Ethics published a study in 2010 that said a rise in recent retractions was the fault of misconduct and “honest scientific mistakes.” It calculated that the number of retractions had more than tripled from 50 in 2005 to 180 in 2009.

The latest publication to highlight this issue is Infection and Immunity. In the fall of 2010, Dr. Ferric C. Fang, editor in chief of the journal made an unsettling discovery – one of his authors had doctored several papers. The journal wound up retracting six of the papers from the author, Naoki Mori of the University of the Ryukyus. It soon became clear that Infection and Immunity was hardly the only victim of Dr. Mori’s misconduct. Since then, according to the blog Retraction Watch, other scientific journals, including the International Journal of Cancer  have retracted another 24 of his papers. This was a new experience for Fang. Prior to this incident Infection and Immunity had only retracted nine articles over a 40-year period. “Nobody had noticed the whole thing was rotten,” said Fang, a professor at the University of Washington School of Medicine. Dr. Fang became curious how far the rot extended. To find out, he teamed up with a fellow editor at the journal, and before long they reached a troubling conclusion: not only that retractions were rising at an alarming rate, but that retractions were just a manifestation of a much more profound problem.

Dr. Fang’s colleague, Dr. Arturo Casadevall, said he feared that science had turned into a winner-take-all game with perverse incentives that led scientists to cut corners and, in some cases, commit acts of misconduct. Last month, in a pair of editorials in Infection and Immunity, the two editors issued a plea for fundamental reforms. While no one claims that science was ever free of misconduct or bad research, the new raft of retractions appears to be a mix of misconduct and honest scientific mistakes. Several factors are at play here, scientists say. One may be that because journals are now online, bad papers are simply reaching a wider audience, making it more likely that errors will be spotted. But other forces are more pernicious. To survive professionally, scientists feel the need to publish as many papers as possible, and to get them into high-profile journals. And sometimes they cut corners or even commit misconduct to get there. To measure this claim, Drs. Fang and Casadevall looked at the rate of retractions in 17 journals from 2001 to 2010 and compared it with the journals’ “impact factor,”  – a score based on how often their papers are cited by scientists. The higher a journal’s impact factor, the higher its retraction rate. The highest “retraction index” in the study went to one of the world’s leading medical journals, The New England Journal of Medicine.

The scramble to publish in high-impact journals may be leading to more and more errors. Each year, every laboratory produces a new crop of Ph.D.s, who must compete for a small number of jobs, and the competition is getting fiercer. In 1973, more than half of biologists had a tenure-track job within six years of getting a Ph.D. By 2006 the figure was down to 15 percent. In such an environment, a high-profile paper can mean the difference between a career in science or leaving the field. The scramble isn’t over once young scientists get a job. “What people do is they count papers, and they look at the prestige of the journal in which the research is published, and they see how many grant dollars scientists have, and if they don’t have funding, they don’t get promoted,” Dr. Fang said. “It’s not about the quality of the research.”

With all this pressure on scientists, they may lack the extra time to check their own research. Instead, they have to be concerned about publishing papers before someone else publishes the same results. Adding to the pressure, thousands of new Ph.D. scientists are coming out of China and India, countries that offer cash rewards to scientists who get papers into high-profile journals. Dr. Fang worries that the situation could be become much worse if nothing happens soon. To change the system, Fang and Casadevall say graduate students need a better understanding of science’s ground rules. They would also move away from the winner-take-all system, in which grants are concentrated among a small fraction of scientists by putting a cap on the grants any one lab can receive. A little bit of old fashioned honesty wouldn’t hurt either!

Drugs That Can Land You in the Emergency Room

It’s midnight at the fire station and a call goes out for a patient who has overdosed. In addition to an ambulance and medic unit, police are dispatched.  As we stage for the police, to ensure that the scene is safe, we speculate as to what we’re going to encounter. Will the patient be conscious? What sort of emotional distress has driven them to this? Is it a serious attempt or a cry for help?  Will there be weapons?

As we mentally run through all types of scenarios, it’s doubtful that many of us have considered that our patient will be an 82 year old great grandmother armed with nothing more than her reading glasses and the remote control.

But increasingly that’s what we might find.  As Americans live longer, we have an increasingly frail population suffering from a greater number of chronic conditions, taking more medications than ever before. Among adults 65 years of age or older, 40% take 5 – 9 medications and 18% take 10 or more.

This type of polypharmacy is associated with an increased risk of adverse events. Older adults are nearly seven times as likely as younger persons to have adverse drug events that require hospitalization.

According to a recent article in the New England Journal of Medicine blood thinners and diabetes drugs cause most of the unintentional overdoses that lead to emergency hospitalization in older patients.

Researchers reviewed the records of 100,000 hospitalization events due to major drug side effects in people aged 65 and above from a representative sample of 58 hospitals.  Almost half, (48%) of adverse drug event (ADE)-related hospitalizations occurred in patients older than 80.

The drugs they looked at included prescription and over-the-counter medications, vaccines, and dietary supplements.

Adverse events were categorized as allergic reactions, undesirable pharmacologic or idiosyncratic effects at recommended doses, or unintentional overdoses.  Other effects included problems due to medication-delivery methods (e.g., choking) and vaccine reactions. Visits for intentional self-harm, drug abuse, therapeutic failures, and drug withdrawal were excluded.

Shockingly, just four medications accounted for more than two-thirds of emergency hospitalizations:

• warfarin (a blood thinner to prevent clots) – 33%
• oral antiplatelet agents (for heart attack prevention) – 13.3%
• insulin (for diabetes) – 13.9%
• oral hypoglycemic agents (for diabetes) -10.7%

Given that emergency hospitalizations caused by ADEs result in significant morbidity and enormous costs it’s not surprising that decreasing harm to patients and reducing costs by preventing re hospitalizations is a goal of the $1 billion federal initiative Partnership for Patients.

Achieving a 20% reduction by the end of 2013 may sound ambitious, but in fact there are a number of simple steps that we can take.

1. Make sure that everyone taking medications has an up-to-date list, including all prescribed drugs as well as vitamins, herbs, and OTC medicines. Copies of the list should be kept in their wallet and should be shared with all doctors they see so that the potential for drug interactions can be assessed and avoided.
2. Alert your loved ones that blood thinners and diabetic medicines account for 50% of hospitalizations due to ADEs. Blood thinners and diabetes medications should be regularly monitored by the primary care physician.
3. Encouraging medication compliance can lengthen a person’s lifespan. Too many times patients stop their medications due to a comment made by a well-meaning friend who has  read something on the Internet. Often the doctor is not informed and the patient may not understand the positive effects of the medication or the dangers of stopping them suddenly.

These small measures may not only save the life of your elderly loved-ones, but they may also  reduce your Word on Health bloggers’ middle of the night 911 dispatches.

A Very Happy Christmas for Patients with Christmas Disease

SRxA’s Word on Health couldn’t resist this story. Not only did it provide us with a seasonal healthcare title but it allowed me to blog about a condition that I have been passionate about for most of my life. As a college student, one of my friends and mentors had hemophilia. He taught me a lot about the disease, about courage and dignity and hope and despair. His death from AIDS left me saddened but determined to pursue a career in healthcare. A few years later I had the opportunity to head up a hemophilia research project in the UK. One thing led to another and I spent the next 20 years of my life involved with transfusion medicine and blood products therapies. Although I’m no longer working directly in that field, later today, I will be running a training course on hemophilia.  I guess you could say it’s in my blood!

For those of you wondering what the above recollections have to do with Christmas Disease, let me explain.

Hemophilia B, a deficiency of coagulation factor IX (FIX) is also known as Christmas disease. Hemophilia is an inherited, potentially life-threatening disorder affecting an estimated 20,000 Americans, almost all of them males. Their blood doesn’t clot properly because of a faulty gene. In severe cases, they can spontaneously start bleeding . Internal bleeding in the joints leads to debilitating movement problems and intense pain.

Unlike most diseases that were named after the doctor that discovered them, hemophilia B is rather special because it was named for the first patient described to have it. Stephen Christmas was born in London, UK in 1947.  He emigrated to Canada at a young age and was diagnosed with hemophilia at age two by Toronto’s Hospital for Sick Children. The family returned to London in December 1952 to visit relatives and, during the trip, young Stephen was admitted to hospital. A sample of his blood was sent to the Oxford Hemophilia Centre where it was discovered that he was not deficient in Factor VIII, which is normally decreased in classic hemophilia A, but a different protein, which received the name Christmas factor in his honor (and later Factor IX).

Now, almost 60 years later, scientists have described the first unequivocal evidence of successful gene therapy for hemophilia. Past gene therapy experiments improved blood-clotting for only a few weeks.

This week, the New England Journal of Medicine reports that a single intravenous injection of an adenovirus-associated virus (AAV) vector that expresses FIX  was successfully used to treat 6 patients  with hemophilia B for more than a year. This is a remarkable breakthrough, given that patients normally need to infuse FIX two or more times every week.

The six men each got a single, 20-minute infusion of AAV. Each saw the amount of clotting proteins in their blood increase from less than 1% of normal levels to at least 2%, and in one case as much as 11%.  Although that may not seem like a lot, it was enough to allow all the men to cut back on the number of regular FIX treatments, and four stopped conventional treatment altogether.

Because their prophylactic use of factor concentrate was either eliminated or reduced, dramatic cost savings were achieved. In the United States, annual costs for a single adult patient with hemophilia B are approximately $300,000. Over a lifetime this adds up to a staggering $20 million. Whereas, the AAV is estimated to cost $30,000 per patient

An editorial that accompanied the study asked: Should the practicing hematologist rush to order this gene therapy vector if it is approved by the Food and Drug Administration?

Their answer – “probably yes!”  Still, they caution that the risks of this procedure are not yet totally clear. In one patient, liver enzyme levels were found to be about five times the upper limit of normal 2 months after gene therapy.

Nevertheless this gene therapy trial for hemophilia B is truly a landmark study, since it is the first to achieve long-term expression of a blood protein at therapeutically relevant levels. If further studies determine that this approach is safe, it may not only replace the cumbersome and expensive protein therapy currently used for patients with hemophilia B, but also translate into applications for other disorders, such as alpha₁-antitrypsin deficiency, and hyperlipidemias.

Now, that really would be a Christmas gift.

The provider will see you now!

Back in the days when I was training, medical students had to study Latin in order to achieve fluency in the language of medicine.  Today, it seems, doctors are learning an entirely new lingo consisting of buzzwords and business speak! According to Pamela Hartzband and Jerome Groopman, two Harvard Medical School / Beth Israel Deaconess Medical Center physicians, current healthcare reforms mean that hospitals are becoming factories and clinical encounters are becoming little more than economic transactions. Writing in the latest edition of the New England Journal of Medicine they claim that, “Patients are no longer patients, but rather ‘customers’ or ‘consumers’. Doctors and nurses have transmuted into providers.” The combination of the ongoing economic crisis and efforts to reform the health care system have resulted in many economists and policy makers proposing that patient care should be industrialized and standardized and that hospitals and clinics should be run like modern factories.  At the sane time, archaic terms like doctor, nurse and patient are being replaced with terminology that fits this new order. In the process, the special knowledge that doctors and nurses possess and use to help patients understand the reason for and remedies to their illness get lost in a system that values prepackaged, off-the-shelf solutions. “Reducing medicine to economics makes a mockery of the bond between the healer and the sick,” they write. Hartzband and Groopman say the new emphasis on ‘evidence-based practice’ is not really a new phenomenon at all. ‘Evidence’ was routinely presented on daily rounds or clinical conferences where doctors debated numerous research studies. Back then, the exercise of clinical judgment, which permitted the assessment and application of data to an individual patient, was seen as the acme of professional practice. Now, health policy planners, and even some physicians, contend that clinical care should essentially be a matter of following operating manuals containing preset guidelines, like factory blueprints. Even more troubling, the authors suggest, is the impact of the new vocabulary on future doctors, nurses, therapists and social workers who care for patients. “Recasting their roles as providers who merely implement prefabricated practices diminishes their professionalism. Reconfiguring medicine in economic and industrial terms is unlikely to attract creative and independent thinkers.” When we are ill, we want someone to care about us as people, rather than as paying customers. Despite the lip service paid to ‘patient-centered care’ by the forces promulgating the new language of medicine, their discourse shifts the focus from the good of the individual to the exigencies of the system and its costs. Should we celebrate the doctors whose practices maximize profits or those who show genuine concern for their ‘customers’ or better still patients? Let us know what you think.

Rogue Reporting

According to an article just published in the Journal of General Internal Medicine, results of drug studies published in medical journals may be misleading.

The UCLA-Harvard study says that the drug trials published in the most influential medical journals including the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet, the Annals of Internal Medicine, the British Medical Journal and the Archives of Internal Medicine are frequently designed in a way that yields misleading or confusing results.

Investigators analyzed all the randomized drug trials published in the above journals between June 1, 2008, and Sept. 30, 2010, to determine the prevalence of outcome measures that make data interpretation difficult.  In addition, they reviewed each study’s abstract to determine the percentage that reported results using relative rather than absolute numbers, which can also be misleading.

They specifically looked at three outcome measures that have received increasing criticism from scientific experts: surrogate outcomes, composite outcomes and disease-specific mortality and found that :

• 37% of the studies analyzed used surrogate outcomes – intermediate markers, such as a heart medication’s ability to lower blood pressure, but which may not be a good indicator of the medication’s impact on more important clinical outcomes, like heart attacks

• 34% used composite outcomes which consist of multiple individual outcomes of unequal importance lumped together, such as hospitalizations and mortality, making it difficult to understand the effects on each outcome individually

• 27% used disease-specific mortality, which measures deaths from a specific cause rather than from any cause. This may be a misleading measure because, even if a given treatment reduces one type of death, it could increase the risk of dying from another cause, to an equal or greater extent

“Patients and doctors care less about whether a medication lowers blood pressure than they do about whether it prevents heart attacks and strokes or decreases the risk of premature death,” said the study’s lead author, Dr. Michael Hochman, a fellow in the Robert Wood Johnson Foundation Clinical Scholars Program at the David Geffen School of Medicine at UCLA’s division of general internal medicine and health services research, and at the U.S. Department of Veterans Affairs’ Los Angeles Medical Center.

Dr. Danny McCormick, the study’s senior author and a physician at the Cambridge Health Alliance and Harvard Medical School, added: “Patients also want to know, in as much detail as possible, what the effects of a treatment are, and this can be difficult when multiple outcomes of unequal importance are lumped together.”

The authors also found that 45% of exclusively commercially funded trials used surrogate endpoints, whereas only 29% of trials receiving non-commercial funding did. Furthermore, while 39% of exclusively commercially funded trials used disease-specific mortality, only 16% of trials receiving non-commercial funding did.

The study also showed that 44% of abstracts reported results in relative rather than absolute numbers, which can be misleading.  “The way in which study results are presented is critical,” McCormick said. “It’s one thing to say a medication lowers your risk of heart attacks from two-in-a-million to one-in-a-million, and something completely different to say a medication lowers your risk of heart attacks by 50 percent. Both ways of presenting the data are technically correct, but the second way, using relative numbers, could be misleading.”

To remedy the problems identified by their analysis, Hochman and McCormick believe that studies should report results in absolute numbers, either instead of, or in addition to, relative numbers, and that committees overseeing research studies should closely scrutinize study outcomes to ensure that lower-quality outcomes, like surrogate makers, are only used in appropriate circumstances.

So who’s to blame?  The pharma companies for using outcomes that are most likely to indicate favorable results for their products, the study authors for writing them up that way or the journals for accepting the manuscripts?  Let us know what you think.

What Matters More?

The doctor’s…or the patient’s perception of their treatment?  Interesting question!  Even more interesting, it is one that was posed in an editorial in the current edition of the New England Journal of Medicine.

The question arose after a new study showed that patients’ self-assessed outcomes in clinical trials can mask a real lack of an objective effect. The accompanying editorial took a completely different stance – asking, “What is the more important outcome in medicine: the objective or the subjective, the doctor’s or the patient’s perception?”

The double-blind, crossover study in question was led by Michael Wechsler, MD, an SRxA Advisor.  It set out to determine whether responses to placebo differ from the physiological changes that occur without any intervention in patients with asthma. To address this, they compared the effects of an albuterol inhaler, two placebo interventions (an inert inhaler and sham acupuncture needle) versus “no treatment” in which patients were told to wait for several hours and then return home.

46 patients with stable asthma underwent each of four treatments over a series of visits. At each visit, lung function was measured by spirometry every 20 minutes for 2 hours.  Also at each visit, patients were asked to score any perceived improvements in asthma symptoms on a visual-analogue scale with scores ranging from 0 (no improvement) to 10 (complete improvement). Patients were also asked whether they thought they had received a genuine therapy or placebo.

Among the 39 patients who completed the study, improvement in maximum forced expiratory volume in 1 second (FEV₁) was significant only after albuterol, however albuterol provided no incremental benefit with respect to the self-reported outcomes.

In other words… from the patients’ perspective all the interventions, except waiting, worked.

While the authors acknowledged that placebo effects can be clinically meaningful and can rival the effects of active medication in patients with asthma, they argued that from a clinical-management and research-design perspective, patient self-reports can be unreliable.  They concluded: “Objective outcomes should be more heavily relied on for optimal asthma care.”

However an accompanying editorial in the same journal questions the authors interpretation.

In it, Daniel Moerman, Ph.D. asks: “Are patients wrong if they report improvement even if there is no evidence for this?” He argues that it is after all subjective symptoms such as wheezing, rather than reduced FEV1 that brings patients to seek medical attention in the first place.

Hence the question, What is the more important outcome in medicine: The objective or the subjective, the doctor’s or the patient’s perception?

All medical procedures whether active or placebo, he argues, are meaningful insofar that they represent something. These meanings create expectations that can dramatically modify the effectiveness of even the most powerful proven treatments. He gives an example of a recent experiment that showed the effects of an opioid drug were either doubled or extinguished by manipulating subject expectations and that  MRI scans showed brain mechanisms differed as a function of these expectations.

Moerman asks: “Do we need to control for all meaning in order to show that a treatment is specifically effective?” Maybe, he suggests, it is sufficient simply to show that a treatment yields significant improvement for the patients, has reasonable cost, and has no negative effects.

What do you think? Is perception reality?  We’d love to know.

Watching What You Eat

In case you hadn’t noticed, the world did not come to an end on May 21^st.  Most of us, so we’re told, were not eaten by zombies. However, we did learn of one 6-year-old boy who nearly lost his life because of something someone else ate.

No, we’re not making this up.  In fact, this story comes from the highly respected New England Journal of Medicine, no less. The article reveals that the boy suffered a severe allergic reaction following a blood transfusion from people that had consumed peanuts in the hours before donating their blood.

Dr. Johannes Jacobs, one of the study coauthors, described how three of the five blood donors in this case reported eating peanuts on the evening before they gave blood. It had been a Sunday evening, the night of a big soccer game, and the three donors had been snacking on peanuts as they watched TV.

The boy who received the nut-tainted blood was being treated for acute lymphoblastic leukemia.  During a platelet transfusion he experienced an anaphylactic reaction in which he developed a rash, angioedema, hypotension, and difficult breathing.  Fortunately doctors recognized his symptoms and treated him with epinephrine (adrenaline) and he recovered within 30 minutes.

The patient’s mother stated that her son had had a similar reaction after eating peanuts at the age of 1 year. Since that time, peanuts had been excluded from his diet.

The authors of the report say the boy experienced an allergic reaction because peanuts contain a protein known as Ara h2, which is extremely resistant to digestion and can stay in the blood for up to 24 hours. While such a scenario had been presented as a theoretical possibility in the past, this is the first clinical report of this phenomenon.

Speaking exclusively to Word on Health, Dan A. Waxman MD, President of America’s Blood Centers said “Donor screening measures are quite effective in terms of detecting infectious agents and donor questionnaires tell us if donors need to be excluded because of medicines they are taking such as aspirin or antibiotics.  But, when it comes to what they’ve eaten, we really don’t ask”.

According to the latest Food Allergy Guidelines,  peanut allergies are known to affect about somewhere between 0.6 and 6% of the population.

While the researchers involved with this study are not recommending that blood donors avoid all foods known to be associated with systemic allergic reactions, they caution that more research must be done to determine the level of risk.

In the meantime, SRxA’s Word on Health suggests it may be time to adapt the phrase “Think before you drink, before you drive” to “Think what you ate before you donate.”

To Give or Not to Give? – That is the question!

Few people in the respiratory community will have missed the study published last week in the New England Journal of Medicine (NEJM) that demonstrated Spiriva is comparable to Serevent in adults with uncontrolled asthma.

For those of you who did, SRxA’s Word on Health is pleased to provide you with a quick recap:

210 people with uncontrolled asthma were enrolled in a three-way, double-blind, triple dummy study.

All patients were treated with a beclamethasone inhaler (Qvar) to which was added Spiriva (tiotropium bromide), Serevent (salmeterol xinafoate) or a double dose of Qvar.

Results showed that Boehringer Ingelheim’s Spiriva, which is not currently FDA approved for asthma,  worked better than doubling the dosage of Teva’s Qvar and was just as effective as GlaxoSmithKline’s Serevent.

Interesting stuff, but in our opinion that was not the real news!

In an accompanying editorial, editors of the NEJM, chastised GSK for failing to provide free study drug to investigators from the National Heart, Lung, and Blood Institute. Apparently manufacturers were approached to supply both active drug and placebo inhalers, and while Boehringer Ingelheim (the manufacturer of tiotropium) and Teva (the manufacturer of Qvar) agreed to provide the materials, GlaxoSmithKline (the manufacturer of Salmeterol) refused.

The net result of this, say the editors was that investigators had to spend $900,000 from the National Institutes of Health (NIH) – and therefore they say, from taxpayers – to repackage the active drug and to create a visually identical placebo for use in the trial.

In a passionate conclusion to the editorial, Curfman, Morrissey and Drazen say:

“The most precious commodity that drug manufacturers possess is the trust of their research subjects, and to maintain this trust they need to be willing to put their products at risk. When they refuse to provide their drugs to legitimate investigators, the researchers will get their studies done without company help. It will take more time and cost more money, but in the end, the research will be done and the company will be perceived as having acted in its own self-interest rather than having worked to enhance the health of the community.”

This story was picked up by various news media who continued the vilification of GSK.

Here at Word on Health we’re not so sure that this criticism is justified.

First, pharmaceutical companies are not required to donate products for third party studies.

Second, Serevent is already licensed for the treatment of asthma. The company has previously performed numerous trials to demonstrate its efficacy and safety, including four studies on its effects in patients with asthma on concomitant inhaled corticosteroids.  In other words GSK did not need this study.

Boehringer, on the other hand did.

Two years ago, safety concerns were raised with Spiriva inhalers. Although the FDA has since said that recent data do not show a connection between the inhaler and previously reported risks of stroke, heart attack and death, doubts continued to linger in the market.  Additionally, as Spririva is not yet approved for use in asthma, any data that could show efficacy in this indication would potentially be an important step in gaining an additional licensed indication.

It is also worth noting that the total cost of the study was > $5.3 million. Tax payers money was being spent regardless.

And finally, it’s not as if Glaxo don’t pay their dues.  They are a member of the Partnership for Quality Medical Donations (PQMD), an alliance of pharmaceutical companies and humanitarian agencies that works to encourage the donation and timely delivery of appropriate medicines to people in need. They were one of the biggest donors of drugs and emergency medical relief following the monsoon floods that hit Pakistan in August; they have provided in excess of $1 million dollars of drugs to Haiti since the earthquake, more than $2 million to South East Asia. They also helped out following floods in El Salvador, wild fires in California, cyclones in Myanmar and the 2009 earthquake in China.

Should companies be forced to donate product to studies that are of no interest to themselves, or should they be free to spend the money and donate their product where they wish?

Should highly respected medical journals be allowed to single out companies for exercising their right to chose how they allocate their product?

Word on Health would love to know what you think.

In the interests of full disclosure we’d like to point out that none of the companies mentioned in this story are current clients of SRxA.