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Increasing Government Oversight Of IRBs Could Help Prevent Seeding Trials

I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.

Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.

isthatamisprint 300x200 Neurontin: Seeds of DiscontentNow, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.

The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.

The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.

The trial worked, from Parke-Davis’ point of view. Read more »

*This blog post was originally published at Pizaazz*

Shingles Recurrence: Can The Vaccine Help?

This month’s Harvard Health Letter has an article about getting shingles a second or even a third time. (Click here to read the full article.) The bottom line is that recurrence is a) certainly possible and b) if some recent research is correct, much more common than previously thought and about as likely as getting shingles in the first place if you’re age 60 or older.

I talked to Barbara Yawn, M.D., director of research at the Olmsted Medical Center in Rochester, Minn., for the article and mentioned results that she and her colleagues first presented at a conference several years ago.

Yawn reported a more complete version of those results in last month’s issue of the Mayo Clinic Proceedings (a favorite journal of mine). Full text of the study isn’t available unless you have a subscription to the journal, but here’s a summary (in medical publishing, such summaries are called abstracts.)

Melinda Beck, a health columnist for the Wall Street Journal,  had a column about shingles last week and this how she neatly summed up Yawn’s research:

For the new study on shingles recurrence, researchers at the Olmsted Medical Center in Rochester, Minn., examined medical records of nearly 1,700 patients who had a documented case of shingles between 1996 and 2001. They found that more than 5% of them were treated for a second episode within an average of eight years—about the same rate as would typically experience a first case.

And here is a link to the Journal Watch item of the study and a short comment by the Journal Watch editor. Journal Watch is a monthly newsletter published by the Massachusetts Medical Society that summarizes and comments on recently published research.

In the Mayo Clinic Proceedings paper, Yawn and her colleagues report that 95 of the 1,669 people with an “index” case of shingles got shingles again over the course of a follow-up period that averaged 7.3 years, which works out to about 5.6 percent of the shingles sufferers. Six people had two recurrences and two had three! The timing of recurrence varied from 96 days to 10 years after the initial episode. In 45 percent of those who got shingles again, the site of the recurrence was in a different region of the body than the site of the first case. They also noted that the single biggest risk factor for having a second case of shingles was having pain that lasted 30 days or longer during the first case. Read more »

*This blog post was originally published at Harvard Health Blog*

Contraceptive Failures: A Reality Check

The media has been buzzing over recent reports of pregnancies occurring in women using Implanon, a single rod progestin-only contraceptive inserted under the skin of the upper arm and lasting for up to three years.

The headlines make it sound horrifying: “Hundreds Become Pregnant Despite Contraceptive Implanon” and “British Pregnancy Scare in UK Implicates Implanon.” I love how terminology can make something so common sound so frightening.

Actually, what happened was that 584 pregnancies occurred in Britain among about 1.3 million women using Implanon, for a failure rate of .04 percent. In other words, the method had an efficacy of over 99 percent. That’s a pretty effective contraceptive if you ask me.

But it should have been better than that

As good as it may seem, this failure rate is significantly higher than most of us would have expected based upon data from clinical trails of Implanon.

I recall being told at an Implanon insertion training just prior to its introduction in the U.S.  that in fact, not a single pregnancy had been reported at that point among users of the device in clinical trails. This would put the method up there with sterilization and IUD in terms of efficacy.

So what happened?

How did Implanon go from perfect efficacy to something less than perfect? Read more »

*This blog post was originally published at tbtam*

HIPAA Stifles Tech Innovation, Developing Nations Take Communications Lead

Sms_your_doctor_mexicoThis picture from 3G Doctor is remarkable.  It captures the flier of a Merck supported Mexican Medmobile initiative that apparently connects patients with their doctors via SMS (translation available on 3G Doctor Blog.)

But don’t expect fliers of this type in American offices anytime soon.  Risk of privacy violation and difficulty in documentation stifle this level of
doctor-patient connectivity.  The very laws created to protect patients may ultimately thwart the timely adoption of new communication channels.

And the slow march towards a single payer system will only make real connectivity a rare bird.

Look to the groundswell in mobile technology and social platforms will force change in our current privacy laws.  Until then look for innovation to come from the second and third world.

*This blog post was originally published at 33 Charts*

Osteoporosis Drugs: Should We Curb Our Enthusiasm?

A recent story on NPR accused the drug manufacturer Merck of inventing a disease, osteopenia, in order to sell its drug Fosamax. It showed how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution.

Osteoporosis is a reduction in bone mineral density that leads to fractures. The most serious are hip fractures, which require surgery, have complications like blood clots, and carry a high mortality. Many of those who survive never walk again. Vertebral fractures are common in the osteoporotic elderly and are responsible for dowager’s hump and loss of height. There is also an increased risk of wrist and rib fractures. Read more »

*This blog post was originally published at Science-Based Medicine*

Latest Interviews

IDEA Labs: Medical Students Take The Lead In Healthcare Innovation

It’s no secret that doctors are disappointed with the way that the U.S. healthcare system is evolving. Most feel helpless about improving their work conditions or solving technical problems in patient care. Fortunately one young medical student was undeterred by the mountain of disappointment carried by his senior clinician mentors…

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How To Be A Successful Patient: Young Doctors Offer Some Advice

I am proud to be a part of the American Resident Project an initiative that promotes the writing of medical students residents and new physicians as they explore ideas for transforming American health care delivery. I recently had the opportunity to interview three of the writing fellows about how to…

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Latest Book Reviews

Book Review: Is Empathy Learned By Faking It Till It’s Real?

I m often asked to do book reviews on my blog and I rarely agree to them. This is because it takes me a long time to read a book and then if I don t enjoy it I figure the author would rather me remain silent than publish my…

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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Eat To Save Your Life: Another Half-True Diet Book

I am hesitant to review diet books because they are so often a tangled mess of fact and fiction. Teasing out their truth from falsehood is about as exhausting as delousing a long-haired elementary school student. However after being approached by the authors’ PR agency with the promise of a…

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