How Industry Views the Research It Sponsors

We have posted frequently about threats to the integrity of the clinical evidence-based, and to the practice of evidence-based medicine.  In particular, we have discussed how research may be manipulated in favor of vested interests, or suppressed when the results do not favor such interests.Last week, the British Medical Journal electronically published a set of guidelines for how industry sponsored clinical research ought to be published, sponsored by the International Society for Medical Publication Professionals.  The authors came from pharmaceutical companies (Johnson & Johnson, AstraZeneca, Pfizer and Cephalon), medical device companies (LifeScan), and medical publishing and medical education and communication companies (John Wiley...

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Gifts and Giving

Now that Black Friday and Cyber Sunday are behind us, it's time to reflect on gift giving. There are been several great articles which provide guiding principles.George F. Will wrote an excellent column about how not to give gifts. When recipients say "You shouldn't have", they're right! Joel Waldfogel, the author of �Scroogenomics: Why You Shouldn�t Buy Presents for the Holidays,� provides a detailed economic analysis of the economic consequences of random gift giving, concluding the best bet is to focus on children and give adults gift cards or named charitable contributions in their honor.Here's the approach I've used with my close family members.My daughter has not asked for any specific gifts (she's not a shopper or someone who seeks the season's "must have" items). She has asked...

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Food Allergies and Thanksgiving

Well, my food allergic child ate chicken on Thanksgiving. He was fine with it, but I really wasn't.When I picked up my "free turkey" (translation: spend $300 in our grocery store and we'll give you a Thanksgiving turkey), I noticed that the ingredients listed an "8% basting solution". I made a note to myself to call the 800 number on the back. My question was simple: What is in the turkey broth and the flavorings in the basting solution? Okay, I shouldn't have waited until the morning before Thanksgiving. But, I've called dozens of manufacturers in the past and always got a quick response to my allergen questions.I started with the phone number listed on the label. It lead me to a recording about directory assistance and charging me $3.79 for a call. I hung up. Then I contacted the corporate...

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More Evidence for Suppression of Research: the Case of Lamictal for Depression

We recently discussed the severe challenges to evidence-based medicine presented by manipulation and suppression of clinical research to serve vested interests.  I recently (and unfortunately belatedly) came upon yet another example of suppression of research that was unfavorable to a research sponsor's vested interests, suggesting that such suppression may be more prevalent than heretofore believed.  This example appeared in the journal Evidence-Based Mental Health [Gahemi SN. The failure to know what isn't known: negative publication bias with lamotrigine and a glimpse inside peer review.  Evidence Based Mental Health 2009; 12: 65-68.  Link here.]The author was able to use the database of clinical trials provided by GlaxoSmithKline as part of a settlement of a suit by...

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What is the "Worst Biotech CEO" Worth?

Recently, we posted about misadventures of the leadership of biotechnology giant Genzyme.  Although the company has long priced its drug Cerezyme for the rare Gaucher's disease at a stratospheric level, it did not sufficiently reinvest money in its manufacturing facility for the drug.  Deferred maintenance at a production facility running at maximum capacity has apparently lead to two different kinds of contamination problems, forcing a shut-down of the plant, and now a shortage of the drug.  For this, Genzyme CEO Henri Termeer was just labeled the "Worst Biotech CEO of '09" by TheStreet.com.It was not always thus.  A 2008 profile of Mr Termeer in Boston Magazine chronicled the rise of Genzyme from a "startup [which] operated 15 stories above the Combat Zone...

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Food Allergies in the Hospital

Those of us with asthmatic and allergic children know that our kids may have a greater chance of hospitalization than others. Their systems are already compromised and viral and bacterial infections can cause more and greater illnesses. When my food allergic child faced a tonsillectomy this summer, I was very nervous about the foods and medicines he would be given. I checked everything in advance to ensure he wouldn't come in contact with his allergens. I also worried about contact issues. Some of the nurses were eating and drinking in the nurses station. They did wash their hands when they came into the room, but I hoped it was thorough enough. And what about people who have an allergic reaction from proteins on the breath?Kimberly Clark has developed a program that is set out to educate...

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A Vegan Thanksgiving 2009

Last year I wrote about my vegan Thanksgiving and the reason I became vegan in the first place.Here's the 2009 menu - healthy, light, and traditional. Since there is no grease, cleanup is easy. Since there is no tryptophan (no turkey), you do not fall into a stupor afterwards.Tofurky - a tofu and grain-based roast available from Turtle Island Foods . I do not typically eat meat substitutes since I enjoy the inherent food qualities of tofu, tempeh and seitan, but a Tofurky is great for family holiday entertaining.Harvest vegetable medley - carrots, parsnips, onions and fresh herbs from our garden roasted at 425FSteamed Brussels sprouts from...

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A Plea for Civility

It's Thanksgiving Day and we should all take time for our families, our mental health, and a pause from the pressures of the modern world. As I've told my staff, it's been a typical Fall - we go from the doldrums of Summer to a sprint post Labor Day with numerous urgent (and sometimes unplanned) projects. This takes a personal toll. Tempers can flare, and patience can run thin. Civility disappears.What do I mean by civility?Webster's calls it "civilized conduct; especially courtesy, politeness"How was your drive to work yesterday? Put another way - what is the shortest unit of measurable time? Answer - the time between the light turning green in front of you and the person honking behind you.Did people stop for pedestrians in crosswalks? Did they let you into merging traffic? Did...

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Status emailicus

My day is spent running meetings - staff meetings, steering committee meetings, and various kinds of national/regional/local governance bodies.Over the past year I have noticed a trend in all these meetings. The number of emails that people receive each day exceeds their ability to respond to them, so they develop "status emailicus" - a bit like status epilepticus (persistent seizures) but it involves retrieving a blackberry, iPhone, or other mobile device from its holster every 15 seconds throughout the meeting.The end result is continuous partial attention. You'd like to believe that everyone is participating in the discussion, especially if complex issues are being debated. Ideally, when consensus is achieved, everyone leaves the meeting marching to the same tune. However, by...

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Food Allergies on the Rise

I couldn't help but run into the headlines throughout the medical community last week. "Food Allergies on the Rise" "20% Increase in Food Allergy in Past 10 Years" So, the news is what many of us already know as we look around our kids' classrooms and schools. More children are carrying EpiPens® and Benadryl® wherever they go. The latest study gives information gathered from 1997-2007. I'm frustrated to find the numbers increasing with no answers about why.Here's just one of the many news articles to report the increa...

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No Free Speech for Comparative Effectiveness Researchers?

We have repeatedly argued why comparative effectiveness research, under ideal circumstances, would be a good idea.  As I said before:Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When...

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A Visicalc moment

If you were an early Apple II or IBM PC user, you may remember the first time you saw Visicalc (1979), SuperCalc (1980), MultiPlan (1982), or Lotus 1-2-3 (1983).The spreadsheet solves a real problem - it saves time, it empowers its users, and people are more productive using it.. No more paper, pencil and calculators. No more days wasted manually computing "what if" scenarios.I call this joy from the early days of personal computing a "Visicalc moment".One challenge we face as we roll out electronic health records to every clinician is that the first time they see an EHR (of any type, from any vendor), they rarely have a "Visicalc moment".Because we have not marketed the benefits of EHRs to clinicians, they are not sure an EHR saves time, streamlines their workflow, or brings them a better...

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Former McKesson CEO and Board Chairman Convicted of Fraud

Continuing with our annals of health care crime, Bloomberg.com reported a new verdict on a very old case:Former McKesson Corp. Chairman Charles McCall was convicted in a second trial of participating in a fraud 10 years ago that cost investors $8.6 billion, one of the largest white-collar crimes at the time.A federal jury in San Francisco yesterday found McCall guilty of five of six counts of securities fraud and circumventing accounting rules. He was acquitted of falsifying records. Sentencing is set for March 2. Ex-McKesson General Counsel Jay Lapine was found not guilty of three charges.McCall and Lapine were accused of hiding backdated sales contracts from auditors and other conduct that improperly inflated revenue figures at San Francisco-based McKesson, the biggest U.S. drug distributor,...

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Aetna Government Contract Discredited

Last week, the Sacramento Business Journal reported on irregularities in how health insurance/ managed care giant Aetna obtained a contract with the US military health plan Tricare:Aetna Inc. hired a former high-level Tricare employee with access to proprietary information about Health Net Inc.�s performance that could have given Aetna a competitive edge in its bid for a lucrative military health care contract, the U.S. Government Accountability Office has concluded.The GAO details six flaws in the procurement process in new documents posted online Tuesday and recommends that Aetna should be excluded from the competition, leaving Health Net 'as the only viable awardee.'The agency recommends Tricare officials perform a thorough review of what sensitive information the former Tricare employee...

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Marketing Interoperability

In the past, it's been challenging to market interoperability because incentives to share data between organizations are often not aligned.You can imagine the following conversation"Hi - I'm from your local health information exchange. You may know that over 20% of lab and radiology tests ordered in our state are redundant and unnecessary. We're solving that problem through interoperability and we need you to invest $300,000 in capital plus $100,000 per year to connect to our state wide exchange. When it's all working, we'll eliminate all the redundancy, reducing your lab and radiology income by 20%. "Interoperability is great for patients, a benefit to society, but can create a loss of income for some stakeholders. How do we sell it?1. Health Reform - if healthcare reform aligns incentives...

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Novelist Named Food Allergy Walk Chairperson

I first reviewed Kristy Kiernan's novel in May 2009. Matters of Faith centers around the Tobias family, the youngest of whom has a peanut allergy. Kiernan, who had no previous experience with food allergies, suddenly found herself in the spotlight of the food allergy community.This fall, Kristy Kiernan, was named the Honorary Chairperson of the Tampa Florida FAAN Walk. Read about her experience to find out how a woman "who didn't set out to write a book about food allergies" has become so important to so many families.I must also say that Matters of Faith would make a wonderful holiday gift for the people in your life who "just don't get food allergies". Kiernan's empathy and realism capture the daily life of many of us who deal with the fear and anxiety of food allergi...

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Cool Technology of the Week

We've all used Google products - Search, Gmail, Blogger, You Tube, Docs, and Analytics. Along the way, we've provided information about ourselves - our preferences, our searches, and our customizations.Google has created a dashboard that serves as a "disclosure log" of everything they know about each user.To access it, go to Google DashboardIt's fascinating to see the accumulated data. Google does have strong policies to provide the Google Personal Health Record (Google Health). Any information related to that product is not mined, resold, distributed or used for advertising in any way.With the Dashboard, I can better understand the data Google gathers about me and be a better informed user.A dashboard that consolidates all information about my use of Google products - that's co...

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Food Allergy From a Tick Bite?

Hmmm....here's a strange one...Some adults who have previously eaten red meat without any problems, suddenly develop an anaphylactic reaction to red meat. They literally suddenly become allergic to meat. What do these adults have in common? They've experienced a tick bite recently."It has changed our thinking," said allergist Saju Eapen, of Roanoke, Va. "This was not something we looked for in the past."While not common, it has some fascinating implications into the study of how food allergies develop. Check out the full sto...

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The November HIT Standards Committee Meeting

The two major agenda items of the November HIT Standards Committee were the lessons learned from the Implementation Workgroup activities and security testimony from multiple industry experts in four panels - Stability/Reliability, Cybersecurity, Data Theft/Loss/Misuse, and Building Trust.We began the day with an overview of the 10 major themes from the Implementation Workgroup testimony. We discussed the ways in which these themes could inform our future work in the upcoming months as we review comments on the interim final rule, consider incremental improvements to the standards supporting meaningful use in 2013/2015, and we consider tools/technologies/education to enhance adoption.Specific action items include:*Work hard on vocabularies and try to get them open sourced for the entire...

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Genzyme's "Remarkable Business'Strategy" and Contaminated Drugs

In June, 2009, an article in the Boston Globe described how the Boston area based biotechnology company Genzyme sold some astonishlingly expensive drugs, usinga remarkable business strategy: In countries from Colombia to Taiwan to Libya, the Cambridge firm has compiled an extraordinary track record of searching out patients like Tania, providing desperately needed treatment, and then successfully pressing their governments, even poor ones, to pay full price for the most expensive drugs in the world.The article focused on how Genzyme marketed Cerezyme for Gaucher's disease.When Genzyme Corp. first introduced a bioengineered drug for Gaucher (pronounced GO-shay) disease in the 1990s, the very idea seemed almost absurd to most people in the pharmaceutical industry. It was expensive to manufacture,...

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Guiding Principles for the HIT Standards Committee

In the past few weeks, the HIT Standards Committee has gathered a significant amount of written and in person testimony from standards stakeholders. We've run the FACA blog and multiple personal blogs. On Thursday November 19, we'll present a complete distillation of everything we've learned but there are several recurring themes can could be called Guiding Principles. Just as HITSP was guided by Harmonization Readiness principles to choose standards that were good enough, the HIT Standards Committee has a been told to think about the following whenever it recommends standards:� Keep it simple; think big, but start small; recommend standards as minimal as possible to support the business goal and then build as you go� Don�t let �perfect� be the enemy of �good enough�; go for the 80%...

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Diagnose Food Allergies: New Tools

New tools are available to allergists in the diagnosis of food allergies. Yes, it still involves a blood test, but results allow for diagnosis at the molecular level. Allergists will be able to identify precisely those patients in danger of severe allergic reaction to allergens such as peanut, wheat, or egg and many others. The exciting news is that personalized allergy management plans can be created with this information. The plan will be uniquely specific to each person.I think this new technology will become extremely important as it will give families, doctors and food allergic patients a specific profile of their reactivity. Right now, we receive a bunch of confusing numbers and statements. To know your child is "higher than 100 for milk" or is "really allergic to peanuts, but not as...

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Seeking NIH to fund studies on medical ethics, conflicts of interest in medicine and research, and prescribing behavior

Adriane Fugh-Berman MD is principal investigator (PI) of the PharmedOut project. PharmedOut is an independent, publicly funded Georgetown University Medical Center project that educates physicians about industry influence on prescribing. project that empowers physicians to identify and counter inappropriate pharmaceutical promotion practices. PharmedOut promotes evidence-based medicine by providing news, resources, and links to pharma-free CME courses.PharmedOut is requesting that the U.S. NIH (National Institutes of Health) fund more research into ethics, conflicts of interest, and prescribing behavior. One hundred researchers, clinicians, and ethicists have signed a letter sponsored by PharmedOut asking NIH to fund research on medical ethics, conflicts of interest, and industry influence...

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