In praise of FDA collaboration: the cardiac safety example

Making it happen

Making it happen

The Food and Drug Administration gets a lot of grief. Some think the FDA is too restrictive, keeping useful drugs and devices off the market and thus harming patients. Others complain that the agency is too lax, letting dangerous products get through. What many people don’t realize, however, is that FDA has established an excellent track record of collaboration with stakeholders that’s leading to better, faster development pathways.

I’m directly aware of FDA’s longstanding constructive, collaborative efforts in the areas of HIV and HCV through the Forum for Collaborative HIV Research. Those efforts are now expanding into liver fibrosis and beyond.

So I was encouraged to to receive the following correspondence over the weekend from Mikael Totterman, founder of iCardiac Technologies, where I’m a board member.

On Friday, I attended the Cardiac Safety Research Consortium meeting hosted by the Food and Drug Administration announcing the results of a new study that promises significant advances and improvements to the way cardiac safety is assessed for new drugs being developed by pharmaceutical companies.

It was a great opportunity to review  over a decade of work that had gone into enhancing one of the key areas of drug development and to reflect on how industry and government collaboration can lead to dramatic enhancements for all parties, especially patients.

Where It All Started – The FDA’s Critical Path Initiative

Back in March of 2004, the FDA launched the Critical Path Initiative to “drive innovation in the scientific process through which medical products are developed, evaluated and manufactured.” The document identified broad critical bottlenecks in drug development that, if tackled, promised to deliver significant improvements to the process of developing new drugs.

Specific Opportunities – Cardiac Safety – Traditionally Very Costly and Hard to Assess Well

By March of 2006, and as result of broad-based industry support, the FDA continued their collaborative work, and rolled out a highly targeted list of specific opportunities for industry collaboration to improve the overall effectiveness of drug development.

One of the key areas highlighted by the FDA across several specific opportunities was how drugs were assessed for cardiac safety issues, specifically for the potential to cause potentially lethal cardiac safety side effects.

“#18. Predicting Cardiac Toxicity. New tools for early identification of cardiac toxicity would improve product development for a wide array of conditions. Research investments that could produce tangible benefits quickly include creation of an ECG library from clinical trials that could be used for identifying potential early predictors of cardiac risk.

#46. Identification and Qualification of Safety Biomarkers. …For example, a robust database of preclinical and clinical data on cardiac arrhythmic risk could help us understand the clinical significance of QT interval prolongation, reduce the need for clinical studies, and, possibly, help identify individuals who are at risk for this side effect….”

Cardiac Safety – Consortia are Born

The level of interest in these opportunities was intense and so two separate industry/FDA consortia were developed to provide a venue and process for validating tools and methods that could tackle the issues in cardiac safety.

The Cardiac Safety Research Consortium was formed in 2006 through an FDA Critical Path Initiative Memorandum on Understanding and the Telemetric Holter ECG Warehouse was formed in 2008.

Significant Progress Unveiled at Cardiac Safety Research Consortium Meeting at the FDA

The Cardiac Safety Research Consortium meeting this past Friday was particularly exciting as it was the culmination of many years of work on the part of the FDA as well as many industry participants and thought leaders.

As the recommendations from the meeting are rolled out, the expectation is that cardiac safety testing in clinical trials will become ever more thorough and at the same time accomplished at a lower cost.

This is something that everyone should celebrate; patients, drug developers and regulators are all better off as a result of this long-term collaborative approach.

photo credit: ePublicist via photopin cc

By healthcare business consultant David E. Williams, president of Health Business Group.


Guest post: Playing with fireball

My long-time friend Gregory Stoller teaches entrepreneurship and international business in Boston College’s MBA program. He’s not really a healthcare guy, so you haven’t heard about him from me before. However, he is the chair of two committees at Hebrew SeniorLife, which provided inspiration for the guest post below.

Gregory Stoller

Gregory Stoller

To climb the corporate ladder, you must consistently deliver against strategic plans for which you have primary responsibility. Most successful C-level executives share that resume item. But with fires constantly appearing, how do you focus on the big picture without getting sidetracked?

A non-business world experience offers good inspiration. I recently attended a seminar hosted by one of the non-profits where I volunteer. It traced the orthopedic patient’s journey through physician consult, to surgery, rehab and eventual discharge, via a series of live, inter-departmental “warm handoffs.” You can’t just throw something over the wall but must thoughtfully pass it to others.

Albeit filled with daunting medical nomenclature, the perioperative lessons are quite transferable to business: Across a patient panel comprising thousands of complicated surgical procedures and unpredictable results, it’s possible to implement systems, bringing order to natural chaos. Even if occasionally imperfect, with enough data, practice and time, entropy eventually does become predictable.

Being productive is as equally personal, as it is classroom content. I have run my own business for well over a decade, so am well versed in plan implementation, extinguishing unexpected roadblocks and keeping investors informed. How to navigate these minefields is part of what I teach to my MBAs.

Yet well removed from teaching anecdotes and boardroom banter, everything still seems eerily reminiscent of Harold Ramis’ film Groundhog Day. Each morning, I calmly review the day’s schedule; the word “planner” is at the top of the page but the irony is never lost. By 5:00 pm, my actual activities could have been associated with someone else’s calendar. Sound familiar?

We have more technological firepower than ever before: instant information access, telephonic phone-in capabilities and an unlimited choice of customized pings as task reminders. In theory, we can plan better than we ever have. But it always comes down to working through those unexpected interruptions.

The secret of the tail not wagging the dog is deconstructing a big picture plan into a series of more attainable, and shorter-term, metrics and milestones. You’ll feel like you’ve accomplished “something” by scaling the smaller plateaus, and cumulatively, should eventually reach the peak of the overall target over time. But don’t ignore the 800-pound gorilla: the path is not linear and nearly always requires twice as much effort and three times your budgeted expense.

Additionally, the top leaders are effective due to their delegation. They’re paid to “think about” the work, not “do” it. By being removed from the daily trenches, they can see the fireball coming, and either deftly hand it off or stop it in its tracks, well before it affects their staff.

Mutually negotiate attainable metrics and rise above the fray of being sidetracked by a passing disruptive breeze. You’ll eventually hit your mark. And be nice to the people cleaning your surgical wound dressing. They might not speak COGS, but they’re Harold Ramis fans, too.

Rough Neighborhood? Partners HealthCare finances dragged down by health plan

Partners HealthCare lost money last year for the first time in 15 years. The Boston Globe covered the story and quoted me. Here’s what I had to say:

“Partners expected that owning Neighborhood Health Plan would give them a low-cost way to gain experience as a health plan,” said David E. Williams, president of Health Business Group, a Boston consulting firm. “Instead what they have found is that running a health plan for Medicaid patients is a difficult challenge and not an easy way to make money.”

By healthcare business consultant David E. Williams, president of Health Business Group.

Home care webinar: Recording available for viewing

We had a great turnout on Wednesday for our webinar Home health: Opportunities for ACOs, health plans and investors. We’ve made a recording of the webinar available for free.

You can view it here.


Do you understand your medical bills? I don’t

Piling up the bills

Piling up the bills

The Consumer Financial Protection Bureau has issued a report that indicates that at least 43 million people in the US have unpaid medical bills. That has consequences since unpaid medical bills hurt credit scores, often substantially. Tellingly, many of these ‘debtors’ don’t have issues with any other creditor.

The report concludes that many non-payers simply don’t understand their medical bills.

I have a confession to make: Even though I’ve been working as a healthcare business consultant for more than 20 years, I don’t understand my bills either. Here are a few of the problems I face –and I know I’m not unique:

  • Providers send bills while insurance claims are still pending, so I don’t understand whether I’m being asked to pay the right amounts
  • Explanations of benefits from my health plan aren’t timely and aren’t informative. The services described sound completely generic and are hard to trace back to the provider bill
  • We now have a high-deductible plan and are being asked to pay more by our providers, but I’m not confident that providers are correctly taking into account our out-of-pocket maximums on an individual and family basis
  • Providers aren’t coding claims in line with the Affordable Care Act or insurance company rules, resulting in incorrect out-of-pocket amounts. (See my recent piece on the on again, off again co-pay for a routine physical)
  • Few providers (at least around here) allow online payments. I have to either call the office during work hours or mail in a check –both a hassle

I’ve said before that unpaid medical bills shouldn’t be counted for credit scoring purposes. And it appears that FICO has also come around to that way of thinking. Still the big problem is that the whole payment system is way too complex, expensive and confusing.

I understand that providers need to get paid, and increasingly that means collecting from patients. There are companies out there, like PatientPay and Simplee, that try to make this process easier. But we’ve got a long way to go.

photo credit: urbanbohemian via photopin cc

By healthcare business consultant David E. Williams, president of Health Business Group.

Cavalcade of Risk 233 is up at

I’ve read all 233 Cavalcades of Risk blog carnivals but today’s edition at is the first one I’ve ever seen done as a rhyme. Truth be told it’s my favorite of them all, so I highly commend it.

I enjoyed it so much I composed a commentary on it:


It’s rare that we see
A blog post so funny
Especially when
The topic is money

But when given a number
Like 233
How could you resist?
It just had to be

I’ve written, myself, many dry, dry, dry posts
But perhaps the next time
When I am the host

I’ll come up with something
As catchy as yours
Which all readers will like
Except for the boors