Eye on FDA

Weekly Roundup - 09-12/08

Well, Congress is back.  You may be relieved that your representation is back at the seat of government, doing that voodoo that they do so well.  For me, it means a longer commute and more bad drivers on the road.  We had torrential, biblical rains here in DC from Hurricane Hanna.  We begin to turn our attention to the change of seasons.  Mums are for sale everywhere.  And today, I start Motorcycle Class man.  I'm too cool for school.

In the meantime, here is a little of what happened this week:

• Podcast with Wayne Pines - If you have anything to do with FDA, then you know Wayne Pines, a consultant to many healthcare interests on matters dealing with the FDA and media.  I had the chance to sit down with him this week and we talked about how quickly both the regulations that govern FDA and modes of communication are changing the face of what healthcare communicators do and what they need to know about.  Enjoy.

• FDA Issues Alert Over Chinese Infant Formula - In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.  The FDA is advising caregivers not to feed infant formula manufactured in China to infants. This should be replaced with an appropriate infant formula manufactured in the United States as mentioned below. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.
• Job with My Employer Fleishman-Hillard - I don't usually do this sort of thing, but since I've been writing so much about digital and healthcare, here is a job available that involves both for those qualified and interested.  Here is the job information on the position.

It has been a rather unpleasant week for me, so I'm signing off. 

A Conversation with Dr. David Kessler, Former FDA Commissioner

Last week, my employer - Fleishman-Hillard, held a public affairs briefing in Washington, D.C. that included several of the members of the International Advisory Board (IAB) for the firm.  The event was co-hosted by the Capitol Hill newspaper  Roll Call and was moderated by Morton M. Kondracke, political commentator and executive editor.  The IAB is made up of people from various industries and past administrations and some of them were assembled to discuss the challenges and priorities that exist for the next elected Administration on several fronts - from healthcare to foreign affairs to finance to trade.

I sat down with several of the IAB participants that day to record their thoughts, and one of them was Dr. David Kessler, former FDA Commissioner from 1990 until 1997, appointed first by President George H.W. Bush and re-appointed by President Bill Clinton. 

It seemed to me that Dr. Kessler led the FDA during much happier times, when the agency was indeed the gold standard.  I asked him to compare the level of scrutiny and Congressional oversight of the FDA today to the time when he was Commissioner.  We also, naturally, discussed the challenges that the FDA faces now, the questions of credibility and the role of leadership, the evolving role of the FDA in a global economy and the prospect of FDA reforms.

Enjoy.

Does Cholesterol Matter? A Conversation with John Carey of BusinessWeek

Every time I hear the sound of my recorded voice, I am reminded why I write so much.  I am still quite rough at the edges.  Nevertheless, I've had the courage to do another podcast, this time with John Carey, senior correspondent at BusinessWeek. 

Cholesterol and statins have been in the news a good deal lately.  Last week, I wrote about the study release about Vytorin, calling into question whether or not it was effective in preventing heart attacks.  The Forbes article headline was that "Study Shows Vytorin Has No Benefit" even though there are emerging studies that demonstrate or suggest other possibilities. 

The January 28, 2008 cover story of BusinessWeek ran a story the title of which raises the question without having the same conviction as the Forbes article.  It is by John Carey entitled "Do Cholesterol Drugs Do Any Good?"

It is a provocative article that does ask important questions.  In it, John Carey explores the efficacy claims of cholesterol drugs when viewed through the lens of the "Number Needed to Treat" (NNT) - which means how many people actually have to take a drug before there is someone who sees a benefit.

The article suggests that the way we traditionally evaluate and promote efficacy may be by means of  too blunt an instrument.   

On the other hand, also this month, data was released to show that deaths from heart attacks and stroke have plummeted in this country - as well as studies that speculate whether there is a role for statins in cancer prevention.  Coincident with that drop has been an uptake in the long-term use of statins among other things, such as improvements in treatment of heart attack and stroke patients. 

Few public health messages have been pounded into consumers heads more than that which says lower cholesterol lowers your risk for heart attack.  I invite you to listen to Mr. Carey as we discuss his article, the role of blockbuster drugs and what this might mean for the future.

And for communicators, whether you agree with the points raised in the article or not, the discussion raises new questions about how we talk about benefits and efficacy - questions that need to be answered.  Will, for example, NNT capture the role of statins, if any, in the longer term statistics (from 1999-2005) that show a 25% drop in heart attack and stroke deaths?  What should be included in the mix when we define benefit and when we define risk?

I had the opportunity, thanks to colleague Ben Finzel, to sit down with Mr. Carey and discuss just a few of the ramifications of these questions: 

Dr. David Acheson

Last week, I had the good fortune to sit down with Dr. David Acheson, Assistant Commissioner for Food Safety at the Food and Drug Administration. I had wanted to meet him ever since reading about him in the Washington Post in July, 2007 in an article entitled "Meet David Acheson:  Your Stomach's Best Friend"

Since then, there have been a number of issues emerging connected with food safety - imports from China, e-coli outbreaks and the like.  As 2008 approaches, it seemed like an opportune time to get his thoughts on the FDA's priorities for food safety in the coming year.

During out discussion he outlined plans by the FDA for future protections and he covered ground related to consumer confidence - what has shaken it and what it will take to restore it.  We talked about Chinese imports in the context of today's global trade environment. 

I think that in the wake of some of the FDA reform aimed at the pharmaceutical side of the FDA mission has taken place this year, in the coming year, there may be a shift by policy-makers to addressing the issue of food safety, with reform perhaps being the creation of a single food agency, rather than the current system of food jurisdiction split between FDA and USDA.  You will hear his thoughts on that front as well. 

He is an extremely eloquent and interesting individual.  Enjoy the podcast.

A Conversation with Jim Greenwood - BIO CEO and President

The newly passed legislation in Congress that will reform FDA and reauthorize the Prescription Drug User Fee Act for another five years is just one example of dynamic change that is occurring in the marketplace. 

This week, I was able to speak with Jim Greenwood, President and CEO of BIO,(representing over 1100 biotechnology companies) to talk about the impact of the reforms - what went into them, and what did not (i.e., a regulatory pathway for follow-on biologics).   We also discussed public perceptions of drug safety standards and how the COX-2 safety scares have shaped the public and policy maker psyche.  Lastly, we discussed how the struggling image of the medicines industry affects public policy outcomes. 

Mr. Greenwood represented Pennsylvania's Eighth District in the U.S. House of Representatives from January 1993 through January 2005 where he served as a senior member of the Energy and Commerce Committee.  From 2001 to 2004, Mr. Greenwood served as Chairman of the Energy and Commerce Committee Subcommittee on Oversight and Investigation with oversight authority over issues in the full Committee's vast jurisdiction.

A Conversation with Pill Book Editor - Dr. Harold Silverman

I had occasion to have a conversation with Dr. Harold Silverman, editor of The Pill Book - a perennially popular resource for consumers to learn about the medicines they are taking,  now in its 12th edition. 

We of course talked about the book and some of its aspects that make it so useful for people, in spite of the advent of the Internet.  We also talked a bit about the development of new drugs and whether or not the FDA has become too risk averse. 

FDA's Dr. Janet Woodcock Discusses Adaptive Clinical Trials

We are all trying to re-enter the workforce after August.  Here in the Beltway, the Congress is headed back and the traffic congestion returns as students everywhere return to school.  Labor Day Weekend has passed and alas, I have put away the white bucks and seersucker suits until next Memorial Day. 

While I took a brief hiatus at the end of August, it was not because I was enjoying a well-deserved vacation, but actuallydue to the fact that I was just so darned busy.  Nevertheless, I did manage to steal a little time to record a podcast with Janet Woodcock, M.D., Deputy Commissioner and Chief Medical Officer at the FDA.  Recently, she authored a commentary on the Critical Path Initiative at FDA that was published August 17.  I, once again, had adaptive clinical trials on my mind, and thought it a good time to ask about the future role of adaptive clinical trials and she agreed to give me the time. 

By way of background, very simply put, adaptive clinical trials are a research design that allows you to change the clinical trial to reflect learnings you may make along the way.  Dr. Woodcock and I covered where they are in their evolution and where the FDA is in terms of working with companies that want to employ adaptive trials. 

I have not posted a podcast all summer.  I miss it!  I hope you enjoy this one.

For other interesting information on adaptive clinical trials by some smart folks, see Derek Lowe's "What You Need to Know About Adaptive Clinical Trials" - a piece in Pharmaceutical Executive, published in July, 2006.  Also, you may want to take a look at an adaptive clinical trials speech by Dr. Scott Gottlieb while he was still at FDA. 

HIV in Africa - A Conversation with Former HHS Secretary Louis Sullivan

Last week the Bush Administration announced that it would be seeking a doubling of the U.S. commitment to fund HIV/AIDS care.  That evening, ABC World News Tonight ran a story on the request and compared before and after photographs of people with AIDS in Africa who had been on the brink of death, appearing completely restored.  The photos were astonishing. 

Dr. Louis Sullivan, the Secretary of the U.S. Department of Health and Human Services (HHS) from 1989 to 1993, served at a time when there were no treatments for HIV outside of AZT and a few other related medications.  He is the president emeritus of the Morehouse School of Medicine where he served as president from 1981 until 1989.  As Secretary of HHS and since that time, he has traveled extensively throughout Africa.

During our discussion, we focused first on HIV prevention efforts in Africa, and whether or not it is backsliding.  We then talked about the impact of efforts through PEPFAR and the Clinton Foundation in expanding access to treatment in Africa.  Lastly we discussed the future and whether or not expensive research and development can be sustained with the disease burden so heavily weighted in the developing world.  The podcast lasts about 12 minutes. 

FDA and Pharma Images - A Conversation with Patrick Clinton - Pharmaceutical Executive Magazine

As noted in this space many times, the images of the Food and Drug Administration as well as the pharmaceutical industry have been suffering greatly, most certainly in the post-COX-2 era.  The result has been a rash of lawsuits, congressional hearings, policy-maker criticisms, lowered employee morale, whistle-blowing, and reform movements at both the state and federal levels aimed at the way medicines are discovered, approved, assessed and marketed. 

Ironically this erosion of public trust occurs exactly at the same time that new medicines are delivering hope and promise to unparalleled numbers of people for a wider spectrum of illness than ever before.  On this Memorial Day, I am once again reminded that only eleven years ago, people with an HIV diagnosis had virtually no treatment options and mortality was staggering.  The toll was tremendous and stupefying.  That is just one example, and perhaps the most dramatic, whereby the research, development and creativity of the pharmaceutical industry has produced nothing short of a miracle. 

I thought, then, that it would be a good idea to get some insight into the current environment by speaking with Patrick Clinton, Editor-in-Chief of Pharmaceutical Executive magazine.  I asked him what the FDA should be doing to face the image challenges and in turn, what industry ought to be doing.  We closed by discussing what he thought were the greatest coming challenges for the CEOs of the pharmaceutical industry over the next two years.  Running time just shy of 15 minutes. 

Supplements and Adverse Event Reporting - A Conversation with the Council for Responsible Nutrition

As reported in the past here, the 109th Congress passed S.3546 - The Dietary and Supplement Non-Prescription Drug Consumer Act - legislation that would make it mandatory for manufacturers of dietary supplements and OTC products to report serious adverse events.  Since then, there has been a lot of curiosity about what the bill, signed into law, means for manufacturers and consumers.  What will change - what will stay the same?

Last week, Steven Mister, J.D., President and CEO of the Council for Responsible Nutrition was able to spare time to sit down with me and answer a few questions about the legislation and its impact. 

The legislation, while requiring reporting, does not touch on consumer education.  I asked CRN about that as well.  We also explored whether or not the passage of such legislation represented a failure of self-regulation by the industry and what other self-regulatory measures CRN was working on.  Lastly, I got his take on what the future looks like in terms of any further regulation of the industry.

Related links - National Advertising Division (NAD) - Council of Better Business Bureaus

- referred to in the podcast by Steven Mister