It’s Y2K All Over Again? Daylight Savings Time Poses IT Issues

New energy conservation regulations mean that daylight savings time will start three weeks earlier in the U.S. this year, posing a “mini-Y2K” problem for multinational corporations in any industry. According to a new study by Forrester analysts Ray Wang and Jeffrey Hammond, the time change will result in one day each month being 25 hours long, and another 23 hours long, wreaking havoc for time tracking. IT platforms with built-in systems designed to account for traditional daylight savings time, will also be at risk.  Given that Y2K concerns were so overblown, the authors worry that companies may neglect to protect their networks from Daylight Savings Time 2007 issues. To access the study, click here (registration required)

FDA Has a New CIO (With Reenginering and Streamlining Experience)

This just in from FDA…

Timothy Stitely will become FDA’s Chief Information Officer (CIO) effective March 5, 2007. 
In his role as the FDA CIO, Tim will strengthen the agency’s information technology infrastructure.  Tim brings a wealth of experience developing and managing innovative and cost effective multi-organizational programs in addition to extensive governmental reengineering and streamlining experience.  
One of the challenges we face at FDA is modernizing and automating our information technology infrastructure to support FDA business goals.  One of Tim’s most recent accomplishments similar to this effort was his leadership at the Centers for Medicare and Medicaid Services (CMS) where he facilitated the design & maintenance of the Medicare Advantage & Part D systems which pay more than $10 billion monthly in benefits. 

Prior to joining FDA, Tim served as the Director, Information Services Design & Development Group with the Centers for Medicare and Medicaid Services (CMS).  While at CMS, Tim led the redesign of a Legacy Fee for Service Shared Systems responsible for processing 100 million Medicare claims monthly and developed, awarded and executed the Enterprise Data Center Indefinite Delivery/Indefinite Quantity (ID/IQ) contract.  This contract provided a mechanism to transition current and new production workloads from 20+ existing data centers into two (2) enterprise data centers and continued the conversion of the CMS Data Center from Research Support into a 24 x 7 Production Data Center. 

Tim is a 2004 HHS SES Candidate Development Program (CDP) graduate.  Prior to participating in the HHS SES CDP, Tim served as Senior Information Technology Advisor to the Scientific Director at the National Institute of Child Health and Human Development at NIH where he was responsible for every aspect of a complex, multi-faceted IT environment. 

Tim holds a Master’s of Science degree in information technology from the University of Maryland University College.

The Independent Drug Service Project: Countering Sales Reps at the Doctors’ Office

A new group  aims to provide some counterbalance to pharma sales rep pitches.  But one question:  When  do they provide this information (I’m picturing an overworked pediatrician with six screaming cases of otitis media in his or her waiting room—when would they find the time to listen to them?  )

Doing Well by Doing Good: GSK’s CEO on Corporate Philanthropy

The company was just recognized yesterday for its corporate philanthropy and has established a $1-million fund for science education.  Bloomberg caught up with Monsieur Garnier yesterday and here’s what he had to say about the company’s approach.

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GSK’s CEO Garnier Discusses Philanthropy and its Role in the Company’s Business Model - Bloomberg Bloomberg - (BLOOM) Feb. 26, 2007. 04:23 PM EST

Chemical Engineers (and All Who Knew Him) Mourn the Passing of Nick Chopey

I was saddened to learn that Nicholas P. Chopey, with whom I’d had the pleasure of working several years ago, just passed away.  Nicholas had been the Editor in Chief of Chemical Engineering magazine for many years, and was Executive Editor of that publication when I was there in the 1990s.  Nick was the antithesis of the stereotypical engineer, with wide ranging interests.  He travelled widely, was a voracious reader, and a conoisseur of opera and classical music. 

But he was also a very fine engineer, the author of numerous reference books and articles,  and an extremely meticulous editor, who applied red ink very liberally whenever a technical concept was not explained as correctly or clearly as possible.  

However, unlike so many editors, and engineers, he was as tactful and diplomatic as could be in making his point, whether he was criticizing a writer, an editor, or a distinguished engineering expert; it was this quality that endeared him to so many people. 

Whenever heated technical discussions or debates began to cross the boundary into argument, his was the quiet voice of reason that  returned everyone to the topic at hand and made the instigators feel ashamed of themselves.

He was, in short, one of that disappearing breed: the gentleman. I’m one of many who will miss him, and send heartfelt sympathies to his family and colleagues.  

New Drug Delivery Device Would Release Meds Through the Night

Leave it to the brilliant minds at the Fraunhofer Institute (who have also been shaking up the world of analytics, but more on that later). They, and other research groups, have just dreamed up a device that would be housed within artificial molars within the patient’s mouth, and release medications at a preset rate, through the night.  To read more about the concept, click here.

Peter Rost to be the Subject of a New Documentary Film

Taking a break from the sea of analytical acronyms at Pittcon—NIR, FT-IR, HPLC, LC, LIMS, TOF —to play Hollywood gossip columnist, with a brief news bulletin. First surprise this week: Al Gore’s winning an Oscar.  Second surprise:  Peter Rost’s discontinuing his blog to focus on a new documentary film based on his book.  Filming reportedly started a few months ago, with an established documentary film maker. No details available yet.

But, in case any of you missed the “original” Rost documentary, click here to watch Ed Silverman’s interviews with Dr. R., which we posted on our web site last Fall.  A number of book editors are reviewing Peter’s novel, “The Wolfpack.”

And, speaking of films, Pharmaceutical Executive just ran an article on the Centocor film with the enviably hilarious headline, “Lights, Action, Psoriasis.”  Which appears to sum up public reaction to that film so far.  John Mack and Ed Silverman both recently blogged on the subject. 

But you can’t blame them (Centocor) for trying a new approach, and at least the patients’ lives were the primary focus 

Covering Pittcon, Back Next Week

Will be away at Pittcon (the spectroscopy and analytical instrumentation conference) in Chicago next week, but will file any interesting tidbits I can. Have a great week (and avoid travelling to the midwest and northeastern US if you possibly can)—we had another snow fall in Chicago last night—not the lovely snow, but the messy, slushy variety.  Will Spring never come?

“The Blockbuster Model’s What Got Us Into Trouble,” Says Former FDA Commissioner Kessler

The recent Kaiser webcast asked four former FDA commissioners what they might do to strengthen the Agency today.  The event was sponsored by SKAPP, the Project on Scientific Knowledge and Public Policy, moderated by Dr. Susan Wood, Research Professor at George Washington University’s School of Public Health’s Department of Environmental and Occupational Health, and web cast by Kaiser, which promises to have a full transcript available shortly.

Invited were former FDA Commissioners  Jane Henney, David Kessler, Frank Young and Donald Kennedy, president emeritus of Stanford and Editor of the AAAS’s Science, who phoned in from the West Coast. 

Dr. McClelland couldn’t make it.  (And, although including him would definitely have shaken things up, Dr. Crawford was  (ahem) not invited.) 

“FDA is a mirror of the crisis in medicine today,” said former Commissioner Frank Young, now CEO of Cosmos Life Sciences Alliance, who served from 1984 to 1989, during which the first HIV/AIDS drug was approved on a fast-track basis, and the first generic drugs were also approved.  “Integrity in FDA is a mirror of integrity within Congress, the Administration and the public. We can’t hold FDA to a different standard,” he said later in the program.

Perhaps Dr. Crawford has become too much of a scapegoat. But, although he may not have been the root cause of all these problems, many of the huge issues that the Agency is struggling with today took concrete shape during Crawford’s very tentative tenure, notably:

•  Politicization of the Agency, with questions of politics superseding science, as was seen with the about-face over Plan B
• Questions of drug safety and scientific integrity within the Agency, and, of course,
• Questions of conflicts of interest, which eventually prompted Dr. Crawford’s resignation.

In addition to discussing potential solutions to these problems, the former commissioners offered  interesting insights into the Agency and those who have run it for the past 20 years. 

A Wish List from Commissioner Alumni

Here are a few sound bites, briefly distilling their comments and suggestions (a more detailed analysis will appear in our next issue of Pharmaceutical Manufacturing):

• A reasonable, professional recruitment process is needed for incoming Commissioners, panelists agreed, with some suggesting that a six-year term-time be set for any Commissioner
• Adequate funding.  Dr. Young recalled having to fulfill 22 unfunded mandates during his tenure.  This funding would cover increased training for FDA scientists, as well as improved inspection and regulation of food. It should also cover a new IT infrastructure–not only the platform but training—that will be required to mine and coordinate data
• More attention paid to Agency staff morale and retention. As Dr. Henney (Commissioner in the late 1990s, and deputy commissioner under Dr. Young)  pointed out, funds have not been available for the past few years to allow reviewers and others to keep their skills sharp. “You want people at the top of their game looking at the scientific evidence that’s coming into the Agency in terms of product reviews.  You don’t want someone whose knowledge is even five years old because you need someone who can go toe to toe with any industry scientist and say ‘No, but’ or ‘you need that.’ Otherwise you don’t have the caliber of person required to make the decision,” she said.
• Increasing Agency authority, and funding, for food-related issues. Establishing a separate Food Agency is not the answer, panelists agreed, but increasing authority over food issues and providing adequate funding for enforcement would be critical. Funding should no longer be under the purview of the Senate Agriculture Committee, Henney said.
• A re-examination of users’ fees.  Panelists appeared to be against the concept of user’s fees, or felt that the concepts behind them should be revisited.  Said Henney, “We need to have an in-depth discussion of appropriated funds vs. users fees and the perception that has resulted from user fee funds funding so much of the Agency’s pre-approval work.”

• More of an R&D focus, and increased scientific training.  Dr. Young recalled when NIH was part of the Center for Biologics, how helpful it was that the reviewer who approved the first interferon, had had six months to study them carefully before beginning the review process.

• A more effective system for the epidemiology of adverse drug reactions, including data collection. Dr. Kennedy adovcated this, recalling what happened during the VIoxx crisis, when much of the ADR data were provided by Kaiser.  

• Educating the public about the Agency’s role in determining the critical balance between approving a new drug prematurely and stymying innovation.  Dr. Kennedy suggests that this balance is still misunderstood and contributing to the credibility issue facing FDA.

• Increasing the Agency’s  ability to monitor the safety of a drug once it’s out there, either through mandatory Phase IV or better focus on post-market reactions.  Direct authority to recall drugs might be another positive solution.

One of the most interesting (of many) quotes during the program came from Dr. Kessler, who led the Agency from 1990 through 1997—an M.D. with a law degree and Congressional experience, who is now dean of UCLA’s Medical School.

 

(This was, clearly,  a group of overachievers)

 

“The model that we’ve based pharmaceutical development on for the past 10 years is simply not sustainable,” he said. “The notion that there are going to be drugs that millions of people can take safely, the whole notion of the blockbuster, is what has gotten us into trouble.”  By us, he didn’t only mean the FDA, but the industry.

 

The issue is not primarily about the Agency, or about drug safety itself, but about “the right drug for the right person in the right dose at the right time,” Dr. Kessler said.

 

A whole economic discussion has to take place, he said, because Big Pharma can’t be sustained within this new framework.  He expects to see retrenching over the next few years, with companies focusing on more, less lucrative drugs targeted to individual patient segments.

 

Dr. Kessler also suggested that it will be the Agency’s job to develop the pharmacogenomics data that personalized medicine will require, rather than leaving that entirely to the industry or academia. “But it will require a higher level of science than the Agency’s seen for years,” he said.

 

For the record, Dr. Woodcock seems to be moving forward on several of these fronts, notably scientific education within the Agency, and she’s even addressing the IT investment and training issues that go along with it.  

 

-AMS

It Ain’t Necessarily So: Science in the U.S. and the Very Strange Story of Marcus Ross, Creationist Paleontologist

Science is in deep trouble in the U.S. I realized this when my eldest daughter informed me, in bemused shock, that a classmate (with a high GPA)  had asserted during a classroom discussion at school, that human beings were “created from mud a few thousand years ago.” 

As Sporting Life, villain in Gershwin’s opera “Porgy and Bess” sang, “It Ain’t Necessarily So.” Lyrics to Gershwin’s song.  To watch a brief clip from Trevor Nunn’s recent production, click here.

Today, all around us, there are people, including physicians, pharmacists, executives and engineers, who take the Bible’s story of creation all too literally.  Oh, yes, and scientists.  I left out the scientists.

82 years after the Scopes trial, poor old Darwin must still “prove” his “controversial” theory. A growing number of U.S. college students (according to research by University of Michigan professor Jon Miller) say they have “doubts” about it. 

(This same survey* revealed that the average U.S. citizen’s knowledge of basic science is increasing to the dizzying point where 28% of the population can now understand basic science articles in newspapers, written to the reading comprehension level of the average 12-year-old.  OK, a few years ago, that figure was 10%, so it’s all good. )

Not to demean anyone’s religious beliefs. But I don’t see any contradiction between religious teachings and science and can’t understand why so many people have trouble reconciling evolution with spirituality. After all, some of the first paleontologists were very religious people, and a few were even ordained ministers.  If one accepts the concept of God as being vast, why couldn’t each “day” of the seven days of Genesis represent millions of years?  Must everything be brought down to a mundane, microscopic level because 10,000 years are so much easier to visualize than 100,000, a million or a billion?

So I was fascinated to read about Marcus Ross, the creationist paleontologist.  who recently received a Ph.D. in paleontology, yet believes that human beings came into being 10,000 years ago.

No doubt there are more like him, although they may not be studying paleontology. Liza Gross in an article published in the Public Library of Science, suggests that scientists need to become more politically active and to push a pro-research agenda to change this picture. 

David Triggle, at the State University of New York (Buffalo) is doing this by starting a new science education program designed to turn out generalists and teachers with a good understanding of science.

Can we give poor Darwin a break, and get people in the U.S. to move beyond ”evolution”  and to become more excited (and informed ) about science?  Especially at a time when the basic body of knowledge is growing, and changing, so quickly. Most people don’t want to dip their toes into this ocean, much less take a refreshing little swim.  

* Other disturbing results from the survey (as summarized in the press): people still don’t know the difference between astronomy and astrology!  There was also an (unfair) connection made between females and anti-science feelings, based on the fact that women were more likely to read the horoscopes and less likely to study science in school….first, does reading a horoscope mean that you actually believe it?  And second, the reasons for more of them not choosing to study science are complex, have nothing to do with innate ability, and will gradually disappear as more role models are provided (and fewer university presidents choose to make demeaning comments at commencement exercises).

-AMS