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April 29, 2006

Former FDA commissioner under investigation

by @ 11:31 pm.  Filed under FDA

Things just seem to keep getting worse for the FDA and the pharma industry. Now it seems former FDA commissioner Lester Crawford is under criminal investigation for financial improprieties and making false statements to Congress. It seemed that something was wrong when just after having been confirmed by congress he abruptly resigned.

The story is on MSNBC but the original article is from the New York Times (registration required). Seems Lester Crawford sold $50,000 in stocks in a company regulated by the FDA shortly after his confirmation and shortly before his resignation. I couldn’t find any other details in a brief search but since the information was obtained through a Freedom of Information Act (FOIA) filing it should be known. A Yahoo and Google news search didn’t turn up the name of the company involved but it came out during a court hearing related to the Plan B fiasco. If the stock he sold ends up being Barr Labs that would be an obvious conflict of interest.

Here is the Google listing of all 131 related news articles (as of Saturday night, Apr 29), but they all say pretty much the same thing.

I’m sure we’ll be hearing more about this in the days or weeks to come.

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    April 28, 2006

    Limit Google Search Results to Web Feeds (RSS feeds)

    by @ 10:19 am.  Filed under Search Tips

    While the Yahoo advanced search page has a pop up menu to limit the file format results to only web (rss or atom) feeds, Google does not. Google does allow you to limit your search to other file formats but unfortunately rss/xml is not one of them. However, you can get the results you want by taking advantage of the advanced syntax Google has available. One of those is the “inurl” command. Almost all feeds contain one of several key words within the url. This includes xml, atom, rss rdf, and feed. While not all inclusive, this will find the vast majority of feeds. Here is an example search for feeds related to science:

    science inurl:(rss OR rdf OR atom OR xml OR feed)

    You need to make sure and include the colon and that there is no space between the colon and the left parenthesis.

    While this is not a perfect solution, it does go a long way towards allowing you to use Google to find only web (rss) feeds. If you enjoyed this tip, then be sure to listen to the soon to be posted Searching the Internet podcast episode 2 where I’ll discuss the various advanced commands in Google and Yahoo as well as other search engine related topics.

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    April 23, 2006

    AIIP Conference Events for Apr 23, 2006

    by @ 6:54 pm.  Filed under Asides

    Closing Keynote Address: Clues for Creating Customer Loyalty: A Systematic Approach to Doing More with Your Existing Clients
    by John Jantsch of Jantsch Communications [ducttapemarketing.com]

    John Jantsch gave a great talk about marketing in a way that worked for the AIIP audience.

    The first thing he said was “Nothing in your business will change until you take action.” He talked about a lot of marketing ideas in terms that were new to me and in a way that didn’t come across as hard selling.

    Although the talk was on customer loyalty John discussed other topics before getting to customer loyalty. He talked about defining your ideal client, identifying the right problem or need to address, and the need to develop a strategy before worrying about tactics. He discussed developing a marketing kit, and a system for lead generation based on advertising, referrals, and public relations as well as a “lead conversion system” involving discovery, presentations, and transactions. Finally, he talked about customer loyalty tool several ways to continually communicate with your clients. This included “drip communication”; at least once a month letting the client know something of interest to them and several other options for communicating with your clietns.

    Here is a brief summary:

    General session IV: The Case Study of the Contented Client

    Preston Smith of Business Information Services LLC

    Preston talked about how he got started and how his direction has changed. originally wanted to design databases for politicians and business; clients were hard to get and the work was low dollar value. lots of competition and many programmer. Now does a lot of GIS demographic studies for schools.

    Will Hann of Freepint and Willco

    1. feedback: need to request feedback and then either do it or tell them why you aren’t going to do it
    2. integration: vertical integration or supply chain integration
    3. shakeout: there will be things you don’t want to do. avoid time consuming tasks; those that take a lot of effort without a big return. if it causes confusion, then separate it out
    4. focus: sometimes difficult to focus after a shakeout. important to have the right business plan and the right people.

    Debbie Schwarz of Library Associates

    Started her business because she was bored and now specializes in recruiting and placement of information professionals.
    A phone call from a law firm in SF changed her outlook and she has branched out into other industries. She shared her experiences; some don’t want to share information. There are those for whom everything is a rush or emergency. Malcontents are those who never seem to be pleased or you just can’t win over . Good clients become friends or mentors and are agreat source of referrals. Communicate with your clients and don’t take things personally. It’s about business and not about you as a person.

    The conference was very informative and it was good to see folks i know and had met at past conferences. Hopefully my posts have piqued your interest and you will join us at the conference next year in Minneapolis, MN.

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    AIIP Conference Events for Apr 22, 2006

    by @ 5:56 pm.  Filed under Asides

    Roger Summit award address: Why Women Absolutely, Positively, Must (Re)Claim their Place in Computing
    Pamela McCorduck

    Pamela talked about the lack of women in computer science and gave some numbers. Women are generally underrepresented in sciences except for biology and she emphasized that computing is important and not just an enabling technology, but allowing you to create your own worlds.

    She also talked about how diversity is important to solving problems and creating growth and briefly covered roles women have played in computing historically. The number of women in computer science peaked in 80’s and has fallen ever since. She mentioned that this situation is likely cultural.

    I’m probably not the best person to comment on this since I am a white male. I thought it was a missed opportunity in that the male members of this particular audience would have been very receptive to helping change the situation from within. I think if there had been some concrete suggestions as to what males could do to help facilitate the needed changes, they would have been willing to try and improve the situation. Instead it seemed to be a call to arms for women to make these changes happen.

    General Session 3 Case Study on CI Tom Waters of DOD (contract) Counterintelligence Officer

    Tom talked about competitive intelligence and how info pros can tap into that market. he mentioned that competitive intelligence is used even if its not called that and that market research and keeping track of what others are doing is indeed competitive intelligence. The following were some of the sources of information he mentioned:

    Regulatory filings (EPA, fire marshals, etc.): lots of competitive info including information regarding foreign companies operating within the US.

    FOIA: Japanese carmaker studied a US navy fighter braking system, which they then copied and applied in the automative industry. This is now a case study in many business schools.

    Consumer Product Safety Commission investigation; test results are available. A paint business can find out about their competitors formula.

    OSHA inspection records and hazardous materials permits are good sources.

    The main focus was on Freedom of Information Act and what all can be found via that avenue. He talked about what kinds of information was available and the information that would not be available. He also mentioned that every agency was different in terms of how quickly they supplied the information and their cost was free up to 2 hours of time or 100 pages; beyond that there would be charges but they were low (figure of ~$50 was given). He also said to succinctly state what information you needed; just saying give me everything isn’t enough. The FBI has great information and it is very detailed but given their backlog, it could take years before you received the information (although they must at least tell you they must respond within 10 days even if its just to tell you it’s now in their cue). Also, he stated companies will hire an independent contractor to do this type of of work since the person requesting the information is public record. This way, their competitors can’t tell who is asking for the information and since the contractor and client would have a non-disclosure agreement .

    It was a very interesting and though provoking presentation.

    Concurrent Session Technology Track

    In the afternoon there were two concurrent sessions; one was a technology track and the other was business. Since I was giving a presentation in the technology track session, I attended it, so I can’t comment on the talks in the business sessions.

    Mark Goldstein gave a talk on gadgets and technology and how computing has changed with a focus on networks primarily. Then I gave a talk on what’s new with RSS in the past year with a focus on what podcasting is how it can be useful to information professionals. Once I’m back in the office later this week I’ll post it to the website along with a link in a post here.

    The afternoon was open and we gathered that evening for a cruise in Biscayne Bay and watched the night lights of the skyline.

    It was a great second full day of the conference.
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    April 22, 2006

    AIIP Conference Events for Apr 21, 2006

    by @ 5:17 am.  Filed under Asides

    Following were the 2006 Association of Independent Information Professionals award winners.

    Myra T. Grenier award: Amy Rose
    Gale Group award: Julie Mellon
    Roger Summit scholarship award: Marge King
    Sue Rugge award: Cindy Shamel
    Presidents award: Will Hann

    I did not attend the first timers gathering but heard there were about 25 people attending a conference for the first time.

    Keynote Speech: Alice Norsworthy, Sr VP of Marketing for Royal Caribbean Int.

    Alice talked about what she as a high volume purchaser of information expects from her provider. She went through a typical day and covered what information she need and this included demographic info, media trends and future options, current trends for future product development, competitive activity, fact gathering for a speech.

    She then went on to outline the opportunities for Information professionals from her perspective and talked about how to get the business and then how to keep the business. She mentioned there is less of a need for descriptive reports and more of a need for prescriptive reports; less of a need for reactive reports and more of a need for proactive recommendations.

    Some of the things Alice looks for in her information provider is to identification of trends and established standards; gather ideas, develop hypothesis or assumptions, determine alternatives, provide a deeper expertise on a topic, and qualitative project management.

    In terms of getting the business her primary ways she identify people she works with is though recommendation of friends, personal experience, professional associations., conference attendees, internet search, and articles.

    She suggested info pros identify their uniqueness and make sure we know our audience as well as build a network and credibility. The following is a list of what she valued from a researcher: knowledge of her business, responsiveness, listens and seeks to understand, simple clear answers in proper context, complete info, data “testing”, and integrity.

    How to keep the business: Alice mentioned several criteria she uses to decide wether to continue to use a certain researcher. These included the information quality and quantity, adherence to standards, confidentiality, and value-added response-insight.

    As an executive, she has to make bold and sometimes irreversible decisions based on limited info and possibly inaccurate forecasts. therefore there is a great need to identify hypothesis vs facts as well as have rigorous data evaluation. She also values the researcher keeping their objectivity and reliability and anticipate executive needs.

    Finally, she talked about delivering the goods by fulling understanding objectives and deliverables, acknowledge the expertise of the person or company that hirer you,. She felt that secure and written communication was vital to success, as well as being on time and budget and respecting confidentiality. She likes to see clear and objective information in context and in a useful format. She also states how important it is to be available for follow-up and to report progress and problems in a timely manner.

    General Session 1 Eric Seeger (Sr Consultant with Altman Weil, Inc.) and Garn Anderson (head of Energizer’s Global Business Intelligence/Competitive intelligence)

    Why, when and how decision makers decide to use our services. This general session was interesting but had audio microphones problems that distracted from the presentation. One of the topics discussed was error and omissions insurance. and from their perspective working within larger companies, they stated they would not work with an independent information professional unless they had E&O insurance. Much of the talk was repetitive of what Alice had stated earlier (another good reason to be the first speaker of the day).

    The talk boiled down to it being very important to build and establish a relationship of trust and honesty.

    General Session 2 Vendors under the Microscope

    I didn’t take many notes during this part since I had already talked to. They updated what was new and some was repeated from the training sessions on Thursday. The vendors were 10K Wizard, Dialog, Lexis-nexis, Factiva, and Skyminder.

    The remainder of the day was included an ice cream asocial and open exhibits to talk one on one with the vendors as well as a “Tips on the Terrace” an informal evening of drinks and desserts and sharing around tables with each table having a facilitator and topic. It was great to be able to share ideas and in my case, educate people on what RSS is and how it might be useful to them.

    I’m looking forward to tomorrow and will recap those events soon.

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    April 20, 2006

    First OTC Diet Drug Receives Approvable Letter And Other Diet Drugs In Development

    by @ 5:00 am.  Filed under Drug Development, Pharma News

    Xenical has passed the first hurdle to going over the counter. The FDA sent an approvable letter to GlaxoSmithkline regarding Alli the name for over-the-counter prescription drug Xenical. This will be the first approved weight loss drug to be sold OTC and will likely be a blockbuster in the huge weight loss market. Xenical has been available by prescription since 1999 and has world wide sales of about $500 million. Although GSK received an “approvable” letter the FDA has asked for more information but it evidently wasn’t much since the company has stated they will not need to submit any more human data. GSK hopes to have Alli in drugs stores before the end of the year. While GSK has licensed the rights for over-ther counter drug, Roche is the manufacturer and still has the prescription rights. This will be interesting since Sanofi-Aventis also has a diet drug called Rimonabant (It may be called Acomplia) in the works. Sanofi-Aventis has been asked for more information by the FDA and that may involve more human testing resulting in significant delays. The company hasn’t commented on what the FDA requested, but some financial houses downgraded Sanofi-Aventis back in February. Merck has also been investigating a drug similar to Sanofi’s known as only as “L-000899055″. Merck has been pretty silent regarding this drug. The weight loss industry should be an interesting to keep an eye on in the next couple of years.

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    April 19, 2006

    Coalition for Healthcare Communication Wants New Rules for Drug Ads

    by @ 12:15 pm.  Filed under FDA, Pharma News

    The Coalition for Healthcare Communication has filed a citizens petition with the FDA to basically require the FDA to make new rules regarding drug advertising. They want make the ads more simpler and easier to understand. I’m all for making the ads simpler and easier to understand but, as I understand the system currently, the FDA does not pre-approve ads for pharmaceuticals. There is much discussion concerning advertising of drugs and I do think it is needed. One thing I’d like to see is every ad on television contain the name and logo of the manufacturer as well as stating what the drug is used for. I still remember being in a room full of people watching televisdion. A drug ad comes on and everyone in the room looks at me when one the females in the room asked “Do I need that?” It was an ad for Viagra.

    I do think the idea of getting input from academics and professionals would be useful but trying to convey the risks vs benefit in a 30 second spot that everyone can agree on is next to impossible. I also think that print ads should probably have different considerations from either a radio spot or a television commercial. It’s a topic I’ve thought a lot about but beyond the few simple ideas I’ve outlines above, I’m not sure how to convey the needed information in such a short span of time. I do think ads may encourage to ask their doctors about certain conditions, but just getting patients to demand a specific drug name at the doctors office doesn’t necessarily improve the overall healthcare situation and may only encourage use of a brand name drugs that may not be appropriate or needed.

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    April 12, 2006

    Von Eschenbach resigning from National Cancer Institute

    by @ 8:30 am.  Filed under FDA

    Recently the acting FDA commissioner Andrews von Eschenbach said he would resign from his position as director of the National Cancer Institute. He had come under fire from various quarters by those who felt that both agencies need a full time director and that one person couldn’t do justice to both. I tend to agree and am cautiously optimistic about the development. The FDA definitely needs a full time director and someone who is going to be around for a while to set the vision for the agency. His approval by the Senate will most likely come under fire due to the political uproar over the Plan B emergency contraceptive and the FDA’s decision not to decide. The FDA told Duramed they need more time to make a decision regarding Plan B being available over the counter.

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    April 11, 2006

    FDA Approves Second Drug for Preventing Influenza

    by @ 9:12 pm.  Filed under Drug Development, Pharma News, Pharma

    A second drug, Relenza (zanamivir) has been approved by the FDA for prevention on the flu.

    zanamivir
    Relenza

    While it has been approved since July 1999 for treating the flu, it is now approved for preventing it. The only other drug approved for prevention of the flu in the US is Tamiflu (oseltamivir phosphate). This is good news in that there are now alternative to Tamiflu if a world wide flu pandemic should occur. Also, Relenza is inhaled while Tamilfu is taken orally. Also, the manufacturing process appears to be much simpler than Tamiflu involving 6 steps and starts from a more readily available material (sialic acid).

    Also, a Taiwan company is said to have cracked the manufacturing process although they have stated they have no interest in infringing on GlaxoSmithkline’s patent on Relenza. The same Taiwan company is said to also have identified the manufacturing process for Tamilfu as well.

    Oseltamivir
    Tamiflu

    I recently posted about Roche having additional contract manufacturers lined up to potentially make Tamiflu if needed.

    Relenza is manufactured and distributed by GlaxoSmithKline; Tamiflu is manufactured and distributed by Roche.

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    April 7, 2006

    Exalead Database Grows Like Crazy

    by @ 10:35 pm.  Filed under Search Tips

    Exalead is a newcomer to the search engine business and has grown at a tremendous rate. At the beginning of Feb they announced their database consisted of over 4 billion web pages and it continues to grow at a rapid rate. It will be interesting to watch how the growth continues and how long it is until they double again. However, I’ve always been of the belief that doubling the amount of garbage doesn’t give you better results. While size is important, it’s more important that the results returned truly reflect what you are looking for. I’ve used Exalead for searches in my area of expertise and they do bring up the best and most relevant sites. I’m hoping that as the database grows, the quality of the relevant results doesn’t suffer.

    One of the things about them that I like is the ability to limit your search results to RSS feeds. After a search, in the bar below the text search box, you have three buttons; audio, video, and RSS. If you click on RSS, it limits your results to those containing feeds. Unfortunately, you can’t get the results of the search by RSS.

    Another thing I like is they have made sure the search engine works under Safari on the Mac platform. The fact that the results include a thumbnail preview of the website is great too. This is definitely a search engine to keep an eye on.

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