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Finding the upside of failed clinical trials

December 1st, 2011 Comments off

Pills by Grumpy-Puddin, http://www.flickr.com/photos/grumpy-puddin/5161814652/

Forbes reported that Astra Zeneca sponsored a drug trial where their lipid-lowering drug, Crestor, went head-to-head with Pfizer’s Lipitor, a strange battle from the start since many considered Lipitor the underdog in the battle. But the results showed no difference in outcome, which for this study was how blockages in the arteries of the heart progressed after treatment.
In other words, the trial resulted in a draw, and delivered a huge blow to Crestor, since it will retain its patent, and associated high price tag, until 2016, while Lipitor’s constituant, atorvastatin, will be available as a generic this week at a fraction of the price of the brand-name cholesterol-lowering meds (http://ti.me/tZf3j6).

This story was intriguing in many ways. First, I think it’s great that the researchers published the results of the study, which Astra Zeneca funded, in the New England Journal of Medicine. It would have no doubt been much easier to sweep these results under the carpet, where they’d join the other dark data of failed clinical trials (http://bit.ly/tn7dBr).

Second, I think it’s important to set a precedence that drugs intended to treat the same condition go head-to-head in properly designed clinical trials. As consumers and patients, we deserve to know how each treatment measures up.

So kudos to Astra Zeneca for taking the high road. The results of the trial will cost the company money in terms of decreased sales. But they made infinite strides in forging a transparent relationship with their customers.

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Photo via Flickr / Grumpy-Puddin

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Peanut allergies and blood transfusions

May 19th, 2011 Comments off

Peanut By ? Biel's ® ? Gabriel Machado ?, http://www.flickr.com/photos/bielmcr/2350165934/

Donated blood is routinely screened for dangerous pathogens – things like HIV and Hepatitis – to make sure there is no threat to the recipient’s health during a transfusion. But a case study just published in The New England Journal of Medicine suggests that viruses are not the only hazards lurking in the collection bag.

The authors of the paper, a physician team from The Netherlands, reported that during a blood transfusion, the 6-year-old recipient suddenly burst out in a rash and started having difficulty breathing. Recognizing the boy was having an anaphylactic reaction, the doctors rescued him with a syringe of adrenaline.

The patient was definitely allergic to something, but quick tests showed that it was not due to latex glove sensitivity or an adverse reaction to a drug. Upon questioning, the boy’s mother recalled that he had a similar reaction after eating a few peanuts a few years back.

Read more…

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Decision Tools For IVF

January 13th, 2011 1 comment

iPhone 4's Retina Display v.s. iPhone 3G by Yutaka Tsutano, http://www.flickr.com/photos/ivyfield/4731067716/I know that I’ve been slow on updates recently — for lack of a better excuse, I’ll blame it on the holiday season.

But things are back in full swing now, and I’ll have a number of new stories in the next few weeks, so stay tuned.

A few days ago, I wrote a piece for Slate’s DoubleX blog, on a PLoS Medicine study where researchers created a prediction model that they say will accurately determine if someone will get pregnant with in vitro fertilization (IVF).

Rather than externally validating their model, the researchers are crowdsourcing their new tool, and have opened it up on the web and a soon-to-be-released iPhone app. I wrote:

By answering nine questions about pregnancy history, the source of the eggs, and the types of fertility medications used, couples can find out their odds of successful IVF, as well as learn how each variable affects their risk profile. For instance, imagine a 33-year-old woman who’s never been pregnant and is using IVF for the first time after a year of trying to get pregnant on her own. Her fertility problems are caused by cervical issues, but she’s still using her own eggs (and has had gonadotropin hormone therapy treatment). According to IVFPredict, her chance of having a baby with her partner via in vitro fertilization is 13 percent. If the couple decides to go with intracytoplasmic sperm injection instead of the normal IVF method of combining multitudes of sperm and eggs in a dish, their odds jump to 42 percent, according to the model.

It’s great to see clinical decision/patient education tools emerge for couples trying to get pregnant, especially those turning to IVF — a procedure that costs about $12,000 for each procedure, and is often not covered by health insurance.

Image via Flickr / Yutaka Tsutano

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Categories: data, medicine Tags: , , ,

Using Blood Pressure Cuffs to Enhance Sports Performance

December 22nd, 2010 Comments off

51/365 (sphygmomanometer) by jasleen_kaur, http://www.flickr.com/photos/jasleen_kaur/4388052026/
Over at Wired Playbook, I have a new article highlighting a sports performance-enhancing technique where blood flow is temporarily reduced to a limb, in order to prime the muscle for future stress during exercise:

The study builds off research first conducted in the 1980s by cardiovascular pioneer Keith Reimer that examined infarcts, areas of dead cardiac tissue that resulted after heart attacks, when blood flow (and, hence, oxygen) were cut off for extended periods of time. Reimer and his colleagues discovered that much less heart muscle deteriorated when the tissue had previously experienced a few training sessions where blood flow was slightly reduced.

It was as if practice makes perfect, and the previous bouts of low blood flow, which researchers refer to as ischemic preconditioning, primed the heart muscle to endure more serious, even catastrophic, events. When a life-threatening heart attack transpired, instead of shriveling away, the preconditioned heart muscle seemed to stand strong.

Read the full story here.

Photo via Flickr / jasleen_kaur

ResearchBlogging.orgJean-St-Michel E, Manlhiot C, Li J, Tropak M, Michelsen MM, Schmidt MR, McCrindle BW, Wells GD, & Redington AN (2010). Remote Preconditioning Improves Maximal Performance in Highly-Trained Athletes. Medicine and science in sports and exercise PMID: 21131871

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Can Asthma Inhalers Enhance Athletic Performance?

December 13th, 2010 Comments off

Inhaler By Neil T, http://www.flickr.com/photos/neilt/10114120/
My latest story for Wired Playbook highlights new research that investigates whether the common asthma medication, salbutamol/albuterol, could enhance athletic performance when taken in extremely large doses.

A research team led by Jimmi Elers at the Respiratory Research Unit at Bispebjerg Hospital in Copenhagen was curious: Although taking a few puffs of salbutamol hasn’t shown a performance boost in past studies, what would a dose that’s, say, 40 times higher than normal do to lung function? And with higher amounts of the drug running through their bodies, would the over-the-top dose cause athletes to hit the upper limit enforced by the new WADA standards when they’re forced to undergo a urine-screening test before competition?

Image via Flickr / Neil T

ResearchBlogging.orgElers, J., Mørkeberg, J., Jansen, T., Belhage, B., & Backer, V. (2010). High-dose inhaled salbutamol has no acute effects on aerobic capacity or oxygen uptake kinetics in healthy trained men Scandinavian Journal of Medicine & Science in Sports DOI: 10.1111/j.1600-0838.2010.01251.x

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Using Cadaver Legs to Study ACL Injuries

November 30th, 2010 Comments off

Foot Control! by TheBusyBrain, http://www.flickr.com/photos/thebusybrain/2592014018/
My latest post at Wired Playbook profiles Mark Drakos, an orthopedic surgeon who uses cadaver legs to test the biomechanics of ACL injuries:

At times, Drakos seems like a typical orthopedist: seeing patients, prescribing meds, performing surgery. But in the lab, Drakos — always drawing on his previous athletic experience — turns orthopedic research into a team sport. Though he works with a dedicated group of researchers, the stars of Drakos’ squad are his custom-built rig, dubbed the ACL Dominator, and the troves of cadaver legs that cycle through the lab for testing.

Read the entire story here.

Photo via Flickr/TheBusyBrain

ResearchBlogging.orgDrakos MC, Hillstrom H, Voos JE, Miller AN, Kraszewski AP, Wickiewicz TL, Warren RF, Allen AA, & O’Brien SJ (2010). The effect of the shoe-surface interface in the development of anterior cruciate ligament strain. Journal of biomechanical engineering, 132 (1) PMID: 20524741

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