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December 08

T’is the season, so instead of a rant, here’s some fun from the poet Clive James:

 Windows is Shutting Down

Windows is shutting down, and grammar are

On their last leg. So what am we to do?

A letter of complaint go just so far,

Proving the only one in step are you.

Better, perhaps, to simply let it goes,

A sentence have to be screwed pretty bad

Before they gets to where you doesn’t knows

The meaning what it must of meant to had….

And the final line:

Those are the break. Windows is shutting down.

Happy Holidays!

November 08

How will the election impact the drug development industry in this country?

According to a recent article in the NewYork Times (October 14, 2008, pg. A18, Drug Industry, Having Long Smiled on GOP, Now Splits Donations Equally. By R. Pear) the pharmaceutical industry is now giving unprecedented amounts of money to support campaigns of Democrats. The proportion of money going to Democrats now meets or exceeds 50% of political spending at each of the major companies.  Considering that Democrats are, and will likely remain, the gatekeepers for legislation, we can only speculate as to whether pharma-friendly legislation will become a new habit for Democrats.  But hasn’t it always been true that he who pays the piper calls the tune?  For good or ill, I predict the election will not have any substantive impact on the drug development industry, at least in the short term.

October 08

Last month the FDA announced a new Web site posting, a quarterly report of drugs that are being evaluated for possible safety concerns.  Drugs become suspect based upon reports in the FDA's Adverse Event Reporting System (AERS), which contains millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients  Unfortunately, this is just another (see Pearls, July/August, above) misguided bureacratic effort to comply with the provisions of the FDA Amendments Act of September 2007.  Why misguided? Because communicating drug risk without also considering drug benefit is itself risky business.  Patients, upon learning that the FDA has fingered a drug as potentially unsafe, may stop much needed medicine out of fear, without consulting their doctor.  Sure, it’s important to monitor drug safety, but this report is a silly and potentially dangerous idea. Let’s hope the FDA comes to its senses and pulls the plug on its new drug safety report right away, or better yet, provides it directly to all registered physicians who can then help their patients make evidence-based decisions. For it to be useful to physicians, however, it will first need a major overhaul in how the information is presented, as it is now pretty unintelligible.

September 08:

I just returned from Seoul Korea where I and colleague Candace Gunnarsson (from S2 Solutions, Cincinnati) presented a workshop at the Asia Pacific meeting of ISPOR (the International Society of Pharmacoeconomics and Outcomes Research).  Our topic, and indeed, the topic of the entire ISPOR meeting, was Health Technology Assessment in Asian-Pacific countries.   My take-home message from the meeting?  Up-and-coming countries like S. Korea, the Phillipines, Singapore, India, and China, have reached a turning point in their national healthcare policy-making.  Their current and increasing %GDP spend on healthcare has created an urgent need for a formalized process of HTA, based upon the systematic collection and appraisal of best evidence.  This process is not yet established in those countries, but now is the perfect time, and they are the perfect places, for the process and impact of HTA to be perfected.  With few historical practices and investments to protect, they can build ideal national HTA programs starting from a clean slate.  Let’s hope they take advantage of this unique opportunity.

July/August 08:

More on the FDA’s Sentinel Initiative – I’ve been thinking….

What’s good about it?   The vision.   Accessing the capabilities of multiple, data systems (e.g., electronic health record systems, medical claims databases) for proactive, real-time safety monitoring of drugs and devices is good. 

What’s bad about it? The fact that the FDA is the one doing it! Everybody knows the FDA is underfunded and understaffed.  The Sentinel Initiative requires too many dots to be connected – the FDA will have a devil of a time succeeding in this century.  More importantly, Congress in its wisdom broke a cardinal rule of Quality Assurance – the data checker is never also the data generator.  But Congress has mandated that the FDA – the data checker par excellence! – also now become the data generator for post-marketing surveillance under the Sentinel Initiative. Congress should have changed the law so that manufacturers are the data generators for post-marketing surveillance, just as they are now for pre-market studies. Manufacturers could utilize the same data systems that the FDA has identified in the Sentinel Initiative white paper.  Truth be told, manufacturers are already doing this, for at least the past 10 years. That’s what “Outcomes Research” is all about.  Every pharma and device company has a department devoted to Outcomes Research, and they are quite facile at analyzing electronic health records, claims and prescription databases.  The FDA would do far better to require industry to do the post-marketing safety monitoring, with active prospective data collection.  The additional cost per product for the manufacturers would be relatively trivial – the reports could be folded into the current PSUR (periodic safety update report) reporting requirements (every 3 months for the first 3 years).  Why should the FDA carry the burden of analysing post-marketing data? They would do far better to develop and publish data and analysis standards for data mining and safety analyses of observational datasets, just as they have previously for the “adequate and well-controlled trials” needed for product approval.

June 08:

The FDA last month announced the Sentinel Initiative to improve patient safety.  The initiative moves the FDA from dependence upon voluntary reporting of post-marketing AEs to proactive surveillance using a system to be created through public-private partnerships.  The system will incorporate existing electronic claims data and medical records data sources maintained by both private and government entities, including CMS, VA, and DoD.  An FDA white paper, titled “The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety,” is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.htmlThe Sentinel System will permit monitoring of a product’s performance in millions of patients in real time, for earlier detection of safety concerns.

May 08:

Blame it on the fact that I’m a baby boomer, but I just cannot shake that generational tendency, for good or ill, to question authority. So when I saw an article recently published in the New England Journal of Medicine that began with the following sentence: “Tens of thousands of patients die each year because of hospitals' failure to adhere consistently to standard procedures of safe and effective medical care.” (Miller FG, Emanuel EJ. N Eng J Med. 2008: 358:765-767), I looked for a citation.  There was none.  I sent a Letter to the Editor requesting a citation, given this is a big, far-reaching assertion, and an assertion I don’t particularly like because of its implied criticism of the medical profession.  No citation has been forthcoming; I highly doubt I will ever see one.  So, giving up on that quest, my simple request for all you readers out there is to always give evidence for what you write, and ask for evidence for what you read.  The [citation needed] mindset is necessary to truly practice Evidence-based Medicine (or Nursing, or Policy). And PS: Don't believe that NEJM statement until you see a citation!

April 08:

The Institute of Medicine has published a report you should know about:  Knowing What Works in Health Care: A Roadmap for the Nation, available at www.nap.edu.  To quote the IOM (Report Brief, January 2008), “This report recommends that Congress establish a single national clinical effectiveness assessment program with sufficient resources, authority, and capacity to facilitate the development of standards and processes that yield credible, unbiased, and understandable syntheses of the available evidence on clinical effectiveness.” This program will have far-reaching implications for the practice of medicine in the U.S., as well as the development, commercialization, and reimbursement of new treatments, if and when it comes to pass.

March 08:

Well, it didn’t take long for physicians to jump on the bandwagon of Internet social networking.  Like Facebook or MySpace, Sermo is an online meeting place, but for physicians only.  It calls itself the nation's largest online physician community. The ramifications of this development are interesting, and only just beginning to be felt.  For instance, in September 2007, Sermo announced that it has signed an "evaluation agreement" with the FDA’s CDRH, allowing the center to temporarily access its content.  The FDA’s device center intends to assess whether Sermoans, either actively or passively via their conversations, can help with postmarket surveillance.  Sermo has also inked deals with pharmaceutical companies, such as Pfizer, who are allowed access as observers, and it plans to aggregate information from the community discussions and sell it to clients. Financial service companies are also able to purchase access as observers, presumably in exchange for insights and trend spotting.  More than 50,000 physicians in the United States are presently in the community.

February 08:

Two new research abstracts are just available from AHRQ:

1. Developing a Distributed Research Network to Conduct Population-based Studies and Safety Surveillance, and 2. Distributed Network for Ambulatory Research in Therapeutics.

http://effectivehealthcare.ahrq.gov/reports/new_research.cfm                         Why might this be important?

Because they are ground-breaking attempts to use data from real-world clinical practices to assess drug effectiveness and safety. The 1st initiative is the the Distributed Network for Ambulatory Research in Therapeutics (DARTNet), a prototype federated network of electronic health record (EHR) data from eight organizations representing over 200 clinicians and over 350,000 patients. The DARTNet prototype will be used to examine the efficacy and safety of oral diabetes medications for type 2 diabetes. The 2nd initiative is development of a scalable distributed research network, starting in six HMO Research Network health plans: Geisinger Health System, Group Health Cooperative, Harvard Pilgrim Health Care/Atrius Health, HealthPartners, and Kaiser Permanente Colorado and Northern California. The first project will be in hypertension, and will merge data from both EHRs and administrative claims data. Stay tuned!

January 08:

According to the British Medical Journal’s BMJ Clinical Evidence (see www.clinicalevidence.com)  the percentage of current treatment interventions that fall into each possible category of knowledge are: Clearly beneficial (13%), likely to be beneficial (23%), trade-off between benefits and harms (8%), unlikely to be beneficial (6%), likely to be ineffective or harmful (4%). unknown effectiveness (46%).  In other words, the effectiveness of nearly half of all medical treatments is not supported by evidence.   And who thought that in 2008 there is nothing left to explore or discover!?

1) define the question
2) collect the evidence to answer it
3) summarize & appraise that evidence
4) act on the evidence
5) measure the result of your actions

But of course, the “easy” is deceptive!  That’s why an experienced consultant in EBM might be helpful.