Medical News Week

Major milestone in the culturing of human blood stem cells

admin — Mon, 18 Feb 2008 15:01:22 +0000

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Happy Belated Birthday, Frederick Douglass [Dispatches from the Culture Wars]

admin — Mon, 18 Feb 2008 11:49:20 +0000

I totally missed this earlier this week and it's so much more important than the fact that it was Valentine's Day. Sandefur has an excellent post on what made Douglass so special. His writings should be part of any American history and civics class.

Source: Happy Belated Birthday, Frederick Douglass [Dispatches from the Culture Wars]

He feels unnerved. Others feel, well, like their guts were blown out of their bodies all over the lecture hall. [Greg Laden's Blog]

admin — Mon, 18 Feb 2008 09:02:43 +0000

This man supplied some of the weaponry used in two major college mass murders. He is eager to continue supplying these weapons in the hopes that someday a good guy will shoot a bad guy. Eric Thompson, owner of Topglock.com, is the goto guy if you need guns, especially the widely loved Glock handgun. The gentleman who killed a half-dozen people at NIU got some of his supplies at Topglock. The guy who killed all those kids at Virginia Tech last year also got some of his armaments at Topglock.com. Topglock: Your specialist in tragedy.

We're having a motto contest for Topglock.com. Here's my entry:

"Online Gun Suppliers don't kill innocent college students ..... Crazy guys kill innocent college students. The Online Gun Suppliers just supply them with the tools they need"

Do you have a better motto? Maybe a jingle or a limerick?

TGSCOM Inc is the name of the company owned by Thompson. TGSCOM owns about 100 different web sites, all selling guns with different advertising angles.

Thompson, of course, is cooperating with police. There have been a number of instances where Thompson has helped the police to trace down the source of a weapon, or to verify documentation on a weapon used in some crime or another. He has helped put criminals behind bars in so doing, according to his web site. It is probably fairly routine for him to have to supply documentation after the fact in murders, mass slaying, and so on.

He claims, on his site (no, you won't find a link here, go find it yourself), that he wants some day to learn that one of his guns was used to stop a tragic crime like the mass murders at Virginia Tech or NIU.

Did you catch this? If you're only paying half attention to this, please stop now and re-read all of the above and see what conclusion you can draw from it.

Eric Thompson has 100 or so web sites selling guns. He happens to have sold supplies to the killers in these two major school shootings. ( ... two empty 9 mm Glock magazines and a Glock holster to Steven Kazmierczak, and a Walther .22-caliber handgun to Seung-Hui Cho, who killed 32 people in April.) It must be true that this guy is providing guns, ammo, etc. to thousands and thousands, and thousands of people, right?

And at this time, when the press goes to interview him, he does NOT have a list of honorable and noble uses to which his guns have been put. He does not have a list of cases where a mass murderer was about to start his slaying, and an owner of a TGSCOM-provided Glock whipped out his or her firearm and stopped the slaying.

He does have a litany of cases where he cooperated with the police in helping them run down a criminal who used a gun purchased from TGSCOM. This involves supplying paperwork required by law. Paperwork that if the NRA had its way, would not be required by law.

Eric does not have any evidence that the widespread distribution of firearms has any effect other than spreading tragedy and mayhem.

Eric Thompson should be stopped, don't you think?

"Were not just the guys who sell the guns.... we're the guys who make guns possible. Getyourglock.com...."

[soruce: Yahoo, via CMF]

Source: He feels unnerved. Others feel, well, like their guts were blown out of their bodies all over the lecture hall. [Greg Laden's Blog]

Additional similarities found between nicotine and opiate addiction

admin — Mon, 18 Feb 2008 06:02:37 +0000

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"That was good!" "Do it again."This is what the brain says when people use tobacco, as well as 'hard drugs' such as heroin.

New research published in the February 13 issue of The Journal of Neuroscience indicates that the effects of nicotine and opiates on the brain's reward system are equally strong in a key pleasure-sensing areas of the brain - the nucleus accumbens.

"Testing rat brain tissue, we found remarkable overlap between the effects of nicotine and opiates on dopamine signaling within the brain's reward centers," says Daniel McGehee, Associate Professor in Anesthesia & Critical Care at the University of Chicago Medical Center.

McGehee and colleagues are exploring the control of dopamine, a key neurotransmitter in reward and addiction. Dopamine is released in areas such as the nucleus accumbens by naturally rewarding experiences such as food, sex, some drugs, and the neutral stimuli or 'cues' that become associated with them.

Nicotine and opiates are very different drugs, but the endpoint, with respect to the control of dopamine signaling, is almost identical. "There is a specific part of the nucleus accumbens where opiates have been shown to affect behavior, and when we tested nicotine in that area, the effects on dopamine are almost identical," says McGehee.

This research is important to scientists because it demonstrates overlap in the way the two drugs work, complementing previous studies that showed overlapping effects on physiology of the ventral tegmenal area, another key part of the brain's reward circuitry. The hope is that this study will help identify new methods for treating addiction - and not just for one drug type.

"It also demonstrates the seriousness of tobacco addiction, equating its grip on the individual to that of heroin. It reinforces the fact that these addictions are very physiological in nature and that breaking away from the habit is certainly more than just mind over matter," says McGehee.

This work is supported by grants from the National Institutes of Health, T32GM07839 and F31DA023340 to JPB, DA015918 and DA019695 to DSM.

Source: Additional similarities found between nicotine and opiate addiction

Slow growth rate found in overall prices in medical technology sector

admin — Mon, 18 Feb 2008 02:48:14 +0000

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AdvaMed, the Advanced Medical Technology Association, has released an important new study that demonstrates the slow rate in growth in overall prices in the highly competitive medical technology sector.

The study's author, Roland Guy King, former chief actuary for Medicare and Medicaid, and Gerald F. Donahoe, found that medical technology is a relatively small and constant share of total national health expenditures (NHE).

"The report's findings are significant in light of recent comments by some suggesting policies to limit the diffusion of and access to advanced medical technology in response to cost pressures. Simply put, medical technology is part of the solution to managing health care expenses and limiting patient access to life-saving, life-enhancing technologies compromises patient health and may actually increase costs," said Edward J. Ludwig, Chairman, President and Chief Executive Officer, BD and Board Chairman, AdvaMed.

"The innovative and competitive nature of the medical technology sector benefits patients by providing continual improvements in care," said Michael A. Mussallem, Chairman and CEO, Edwards Lifesciences, Chairman, AdvaMed Board Committee on Payment and Healthcare Delivery, and AdvaMed's Board Chairman-Elect. "This study shows that there is also an economic benefit of competition due to the relatively slow rate of growth in overall industry prices."

"The report's findings are clear: the highly competitive medical device marketplace is working and delivering tremendous value both in patient care and in economic terms. Policies that stifle innovation, interfere in the marketplace or limit access to care threaten that success," said Stephen J. Ubl, president and CEO of AdvaMed.

In 2004, the latest year studied, spending on medical devices and in vitro diagnostics totaled $112 billion or 6 percent of total NHE, and has stayed relatively constant at that modest proportion for the last 15 years. During that same period, overall medical device prices grew far more slowly than either the Consumer Price Index (CPI) for medical services or the CPI overall.

The report also found that during the 15-year period studied, medical device prices have increased at an average annual rate of only 1.2 percent compared to 5 percent for the Medical Consumer Price Index (MCPI) and 2.8 percent for the CPI.

"Medical device prices, on average, have grown at less than half the rate of the overall CPI and less than one-quarter the rate of other medical goods and services. Medical technology is clearly delivering tremendous value to American patients," said Ubl.

As the report notes, "This relatively slow rate of price increase suggests that the industry is highly competitive."

Please visit AdvaMed's Web site at www.advamed.org to see a copy of the study.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

Source: Slow growth rate found in overall prices in medical technology sector

The Presidential Science Debate That Happened TODAY In Boston! [The Intersection]

admin — Mon, 18 Feb 2008 01:27:34 +0000

Many said it would never happen so call February 16, 2008 'historic' because there's been a science debate here in Boston at AAAS (the largest science conference on the planet) between the presidential campaigns!

With a day's notice, conference organizers invited representatives from all the candidates in both parties to come to a session moderated by Claudia Dreifus of the NYTimes. The Clinton and Obama camps took the invitation very seriously demonstrating they not only care, but indeed, they want to be engaged in discussing the significance of science and technology on the campaign trail. By yesterday afternoon, AAAS put out an announcement that the event would happen at 3:30 Saturday--and today's venue was PACKED! (Whoever said scientists aren't interested in politics?)

The debate was a 90-minute format and I sat alongside friends and fellow SD'08 steering committee members Lawrence Krauss, Matthew Chapman, and Austin Dacey. Each campaign representative was first given eight minutes to introduce their candidate's platform on science and technology followed by a question and answer period. Claudia did an extraordinary job of introducing why this is so necessary and choosing the questions we all want to ask...

What are the candidates plans if elected regarding science and technology? Both promised enormous increased funding for research and education, and Claudia followed by asking about the details on how they plan to do it. How do they feel about investing on projects like exploring Mars and what sets them apart from the other candidates and the current administration? The audience had the opportunity to submit questions as well which included inquiring what their administration's priorities would be, how science will be utilized to better inform policy decisions, who the candidates will look to for honest information, and much, much more. The list goes on and on and will shortly be available on the AAAS website. [Check back here soon for details on what was said and how each side performed--including photos and possibly video.]

And the best part? The climax that launched a round of tremendous applause from the audience: Claudia asked both representatives: Will your candidate be at ScienceDebate2008 on April 18th in Philidelphia?

'Time will tell' from Clinton's camp, to which Obama's rep reported it's being very seriously considered, followed with an enthusiastic, 'I endorse it!'

So... A Presidential Debate on Science and Technology? Well, it sure doesn't seem all that outlandish anymore! Clinton and Obama have certainly demonstrated in a very public way that they care and are prepared to make a strong case for science in their candidacy.

Just think, in two months nearly the entire scientific community has embraced ScienceDebate2008 along with leaders in business, politics, and beyond. And the campaigns are listening--Boston today serves as evidence! We hope you'll help make it happen: Contact the campaigns and tell them you want the presidential candidates to attend ScienceDebate2008!

And stay tuned, because this is only the beginning... the prelims for the main event on April 18th!

Source: The Presidential Science Debate That Happened TODAY In Boston! [The Intersection]

Physicians Expect to Decrease First- and Second- Line Use of Vytorin in Wake of ENHANCE Trial Results, According to Study by GfK Market Measures

admin — Sun, 17 Feb 2008 19:47:22 +0000

EAST HANOVER, N.J.--(BUSINESS WIRE)--Feb 14, 2008 - Reacting to the release of the ENHANCE trial results that showed Vytorin, a combination of the statin simvastatin (Zocor) and ezetimibe (Zetia), provides no benefit over simvastatin alone in preventing the progress of arterial plaque buildup, physicians indicate they will shift Vytorin heavily to third-line, rather than first- or second- line use, in treating patients at risk for coronary heart disease, according to new research by GfK Market Measures.

While the research showed universal awareness of the ENHANCE results across all specialties--internists, general/family practitioners and cardiologists--general/family practitioners assert the most negative response to the trial findings. Respondents in this group anticipate nearly double the decline in first-line use of Vytorin (net change of -20 percent of patients), compared to those intended first-line prescribing figures reported by cardiologists (-9 percent of patients) and internists (-7 percent of patients). Use of Vytorin as second-line therapy is anticipated to decrease across all specialties, ranging from -8 percent to -14 percent of patients. Conversely, all specialties indicated an increase in third-line use of Vytorin, with a positive net change ranging from +20 percent to nearly +30 percent of patients.

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As a further indication of general/family practitioners' particularly negative response to ENHANCE, respondents from this group participating in GfK Market Measures' 2008 Vytorin Market Event Study reported they will switch more than 40 percent of their patients currently on Vytorin or Zetia to other therapies over the next few months. In comparison, cardiologists and internists participating in the research study anticipate making the switch among a smaller portion of their patients (ranging from 25 percent to 30 percent).

"In light of the ENHANCE trial results' impact, there is obviously an opportunity over the next several months for Lipitor and Crestor to capture additional market share," said Anna Marie Napolitano, vice president and category business leader, cardiovascular, GfK Market Measures. "On the other hand, for Vytorin and Zetia, our research shows a window of opportunity to mitigate the negative impact of the trial results. With physicians counseling patients to wait until their next visit to discuss alternative therapies, Merck and Schering are challenged to provide credible evidence of advantages to maintain existing patients on the drugs, particularly as the FDA's review and report on the trial are not expected until later this year. As evidenced by this study, general/family practitioners will be critical targets for such efforts, as they show the strongest propensity to transition patients to other therapies."

More Than 150 Physicians Share Their Insights

Reflecting insights from 150 physicians including general/family practitioners, internists and cardiologists, fielded via Internet questionnaire during January 2008, GfK Market Measures' 2008 Vytorin Market Event Study provides insights into physicians' reactions to the ENHANCE trial (examining the effects of the combination ezetimibe and high-dose simvastatin vs. simvastatin alone on the atherosclerotic process in patients with Heterozygous Familial Hypercholesterolemia) results, which were released on Jan. 14, 2008.

About GfK Market Measures

GfK Market Measures provides health care clients with a unique mix of custom and syndicated solutions to support the full marketing continuum, including market assessment, brand tracking, sales force effectiveness, health care consumer and product launch applications. GfK Market Measures is a member of the GfK U.S. Healthcare Companies, the largest provider of custom health care marketing research services in the United States. For further information, visit www.gfkmarketmeasures.com. For more details on this study or to schedule an interview with a GfK Market Measures executive, please contact Jessica Makovsky, group vice president of communications, GfK U.S. Healthcare Companies, at 215.283.3200 x372 or jmakovsky@gfkushc.com.

Contact

GfK U.S. Healthcare Companies
Jessica Makovsky, 215-283-3200 x372
Group VP Communications
Fax: 215-283-3201
jmakovsky@gfkushc.com

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Source: Physicians Expect to Decrease First- and Second- Line Use of Vytorin in Wake of ENHANCE Trial Results, According to Study by GfK Market Measures

Missing Price Information Hampers Usefulness of State Prescription Drug Web Sites

admin — Sun, 17 Feb 2008 14:50:58 +0000

WASHINGTON, Feb. 13, 2008 -- Extensive gaps in price information seriously hamper the effectiveness of state drug price comparison Web sites, according to a study released today by the Center for Studying Health System Change (HSC).

As of late 2007, 10 states had Web sites providing prescription drug prices available at retail pharmacies -- Connecticut, Florida, Maryland, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York and Vermont. More states, including California, are about to launch Web sites, while a few states, including Ohio and Washington, have discontinued initiatives, according to the study.

All but one of the states use Medicaid pharmacy claims data, which often contain usual and customary price information. The usual and customary price is not the actual price paid by Medicaid for prescription drugs but generally represents a pharmacy’s retail price to a cash-paying customer, absent any discount. The clear drawback to using Medicaid claims data is that price information will only be available in cases where a pharmacy submitted a Medicaid claim containing a usual and customary price for a particular drug, according to the study.

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Moreover, insured and uninsured consumers face different retail prices for their prescriptions, and the usual and customary prices posted by state price comparison initiatives generally are relevant only to the uninsured. Insured consumers typically are eligible for prescription drug prices negotiated by pharmacy benefit managers (PBMs), which use volume purchasing power to obtain lower prices. Even insured consumers who are paying completely out of pocket -- because they have not yet met a deductible -- typically are eligible for negotiated prices and often have access to online price tools provided by PBMs.

“Missing price information seriously limits the usefulness of existing state prescription drug Web sites,” said Paul B. Ginsburg, Ph.D., president of HSC, a nonpartisan policy research organization funded in part by The Robert Wood Johnson Foundation (RWJF).

Funded by the California HealthCare Foundation and RWJF, the study’s findings are detailed in a new HSC Research Brief -- State Prescription Drug Price Web Sites: How Useful to Consumers? -- available online at http://www.hschange.org/CONTENT/966">http://www.hschange.org/CONTENT/966. The study was based on a review of the 10 Web sites, including an in-depth review of the Florida site. To conduct the analysis of MyFloridaRx.com, drug price searches were conducted using two strategies -- a Top 10 drug list and a set of consumer drug profiles -- applied in different geographic markets: urban, suburban and rural.

Of the five consumers profiled, only one consumer would find her information needs substantially met by using MyFloridaRx.com. The four other consumers had at least one medication for which the Web site provided little or no price information, highlighting the limitations of using Medicaid claims data.

“An alternative approach -- one that has been considered by policy makers in several states but adopted by none to date -- is to require pharmacies to submit prescription drug price lists on a regular, frequent basis to a state agency,” said HSC Senior Researcher Ha T. Tu, M.P.A., a study author along with Catherine G. Corey, M.S.P.H., an HSC research analyst.

Other key study findings include:

* Among the state Web sites, the number of drugs with price information varied widely, ranging from as few as 26 drugs in Maryland to as many as 400 drugs in Minnesota. Two states, Missouri and New Hampshire, include any drug for which a Medicaid claim was submitted during the reporting period. Some states exclude drugs that have the potential to be abused-including painkillers like hydrocodone and lifestyle drugs like Viagra -- no matter how commonly prescribed.

* Most state Web sites provide price data for multiple formulations of the same drug, which often can be prescribed in several dosage levels and forms (e.g., capsule, liquid). Florida, for example, presents price data for 650 different drug formulations, representing 100 distinct drugs. In contrast, Maryland offers price data for only one formulation per drug -- an approach that limits the Web site’s usefulness.

* Comprehensiveness of drug price information depends not just on the number of drugs and formulations covered, but also the completeness of price information provided for those drugs. For example, a Web site that has a long drug list but contains a great deal of missing price information would offer consumers limited shopping opportunities. The analysis found that, among all the states with drug price comparison Web sites, none has a data collection approach that provides complete pharmacy price data, because none requires pharmacies to report drug prices.

* Another limitation of most state Web sites is that price information is restricted to local pharmacies, when online pharmacies, both U.S. and foreign, often sell prescription drugs at substantially lower prices. To further enhance consumer shopping tools, states might consider expanding the types of information provided, including online pharmacy comparison tools, lists of deeply discounted generic drugs offered by discount retailers, and lists of local pharmacies offering price matches.

### ###

The Center for Studying Health System Change is a nonpartisan policy research organization committed to providing objective and timely research on the nation’s changing health system to help inform policy makers and contribute to better health care policy. HSC, based in Washington, D.C., is funded in part by the Robert Wood Johnson Foundation and affiliated with Mathematica Policy Research, Inc.

Contact:
Alwyn Cassil
(202) 264-3484
acassil@hschange.org

Latest Pharma News...

Source: Missing Price Information Hampers Usefulness of State Prescription Drug Web Sites

West Concludes Agreement with Nektar

admin — Sun, 17 Feb 2008 13:47:38 +0000

- Expects to Recover Investments in Dedicated Assets -

LIONVILLE, Pa., February 13, 2008 /PRNewswire-FirstCall/ -- West Pharmaceutical Services, Inc. today announced that it has concluded an agreement with Nektar Therapeutics, Inc., relating to the manufacture and assembly of components for the Exubera(R) inhalable insulin device. Production of the device was suspended in October 2007 following Pfizer, Inc.'s decision to discontinue marketing the product, returning the marketing rights to the Company's customer, Nektar. Financial terms of the agreement were not disclosed.

Under the new agreement, West will be reimbursed for facility, inventory, raw materials and personnel costs at levels that are consistent with the Company's previously announced expectations. In order to assure Nektar of a reliable source of supply as it resolves its plans for the Exubera product, West has agreed to maintain the facility for a period of between two and ten months.

West expects to recognize an impairment charge of $12.9 million, in line with its previously disclosed estimate of between $11.0 million and $13.1 million, in the fourth quarter of 2007 for its investment in the Nektar contract.

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West will announce its results for the fourth quarter and full year 2007 on February 21, 2008.

About West

West is a global manufacturer of components and systems for injectable drug delivery, including stoppers and seals for vials, and closures and disposable components used in syringe, IV and blood collection systems. The Company also provides products with application to the personal care, food and beverage markets. Headquartered in Lionville, Pennsylvania, West supports its partners and customers from 50 locations throughout North America, South America, Europe, Mexico, Japan, Asia and Australia. For more information, visit West at www.westpharma.com.

 Exubera(R) is a registered trademark of Pfizer Inc. Contacts: West Michael A. Anderson Vice President and Treasurer (610) 594-3345 Investors and Financial Media: FD Evan Smith / Theresa Kelleher (212) 850-5600

wst@fd.com

CONTACT: Michael A. Anderson, Vice President and Treasurer, West,+1-610-594-3345; or Investors and Financial Media, Evan Smith or TheresaKelleher, both of FD, +1-212-850-5600, wst@fd.com

Web site: http://www.westpharma.com/

Ticker Symbol: (NYSE:WST)

Latest Pharma News...

Source: West Concludes Agreement with Nektar

Cellartis Enters Into a Research Collaboration with Pfizer to Develop a Screening System for Detection of Human Toxicity

admin — Sun, 17 Feb 2008 08:58:23 +0000

GOTHENBURG, Sweden, Feb.12, 2008--Cellartis today announced it has entered into a collaborative research agreement with Pfizer for the development of a novel model system for the detection of human toxicity in vitro. The collaboration aims to generate a predictive developmental screening model for new chemical entities using the unique patented Cellartis human

Embryonic Stem (ES) cell platform.

It is important to identify toxic substances as early as possible in the drug development process. Through this collaboration, Pfizer and Cellartis are embarking on potentially pioneering work on human relevant developmental toxicity models, which may yield a solution long sought by the industry. While presumed human teratogens are presently identified using data from mouse, rat, or rabbit, the novel human ES cell-based system would enable the identification of genuine human developmental toxicity data at the pre-clinical in vitro stage.

Cellartis will take the lead in the development of the human ES cell model system and will conduct validation compound testing. Pfizer will provide expertise and capabilities in the design and optimization of the developmental toxicity prediction model.

The collaboration provides Pfizer with access to specific human ES technology, based on Cellartis’ patented human ES platform, for developing the toxicity screening system.

Cellartis receives an upfront fee as well as research funding from Pfizer. In addition, Cellartis retains the right to sublicense, to make, use, and sell the developmental toxicity screening model.

Announcing the collaboration, Mats Lundwall, the Chief Executive Officer of Cellartis, commented:

”We are delighted that Pfizer has chosen to collaborate with Cellartis in the human ES field. We are confident that the unique characteristics of our human ES cell technology have the potential to produce breakthroughs in the prediction of human developmental toxicity. I can think of no stronger partner for Cellartis in developmental toxicity research than Pfizer.”

ENDS

Cellartis Enquiries

Dr Johan Hyllner, Chief Scientific Officer Dr Raimund Strehl, Head of Development

Tel. +46 (0)31 7850902 Tel. +46 (0)31 7850950

E-mail: johan.hyllner@cellartis.com E-mail: raimund.strehl@cellartis.com

About Cellartis

Cellartis AB is a Swedish/British biotechnology company focused on human embryonic stem (hES) cells for drug discovery, toxicity testing and regenerative medicine with the main objective to develop hepatocytes and cardiomyocytes from these cells. The company is the world’s largest single source of defined hES cell lines, and has developed more than 30 well documented cell lines. Two cell lines are listed on the NIH Stem Cell Registry and 22 are approved by the UK Stem Cell Bank. In addition, Cellartis has built the world’s first large-volume production facility for human ES cells. The company’s strategy is to accelerate product development by working in partnership with academia and industry.

The company was founded in 2001, has 49 employees and is located in Gothenburg, Sweden and Dundee, UK.

For more information, please visit www.cellartis.com

E-mail: info@cellartis.com

Address Cellartis AB Sweden Address Cellartis AB UK

Arvid Wallgrens Backe 20 Maclagan House, 1 Würzburg Court

SE-413 46 Göteborg Dundee DD2 1FB

SWEDEN UK

Tel: +46 (0)31 7580900 Tel: +44 (0)1382 569970

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Fax:+46 (0)31 7580910 Fax:+44 (0)1382 568242

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Source: Cellartis Enters Into a Research Collaboration with Pfizer to Develop a Screening System for Detection of Human Toxicity