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Open Source In The Pharmaceutical Industry

January 20th, 2010 No comments

[Jose's comment]

You may find this older (2003) paper of interest.

New innovation and development models may be needed as the pharma industry faces a “patent cliff” {http://www.economist.com/theworldin/PrinterFriendly.cfm?story_id=14742621}.

The role of Open Source-like development and business models are not limited to software development any more. Cheers.

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Download full paper from:
http://lacal.net/files/NIMAN-KENCH.doc

OPEN SOURCE IN THE PHARMACEUTICAL INDUSTRY

Neil B. Niman, University of New Hampshire
Brian T. Kench, University of Tampa

ABSTRACT

Recent evidence suggests that pharmaceutical companies focus more on managing their intellectual property rights than in developing drugs that cure medical problems. The open source movement offers alternate rules for the process of developing new drugs and managing intellectual property rights. The essence of open source is to radically change the development process before there exists something worthy of being assigned a set of rights.  Open source in the pharmaceutical industry also offers the potential to reduce the time it takes to develop breakthroughs, test their viability and safety, and bring them to market.

Categories: Health IT, Open Access Tags:

[NYTimes] Sen. Grassley Seeks Details on Medical Financing.

December 8th, 2009 No comments

[Jose's Note]

What Sen. Grassley is doing is wonderful and much-needed. Sen. Grassley is also looking into Health IT vendors. http://blogs.wsj.com/health/2009/10/26/chuck-grassley-has-a-few-questions-for-the-health-it-industry/

Take a look at this letter Sen. Grassley sent to HIT vendors: http://s.wsj.net/public/resources/documents/WSJ_Letter_3M_Company_2009-10-16.pdf

..In addition, it has been reported that HIT/CPOE manufacturers rely on a legal doctrine known as “learned intermediaries,” to shift responsibility for errors in the HIT systems to physicians, nurses, pharmacists, and other health care providers. The manufacturers allegedly argue that the health care provider should be able to identify and correct errors caused by the software. It has also been reported that HIT/CPOE contracts with medical facilities may include “hold harmless” provisions that absolve manufacturers of these products of any liability for errors that are allegedly HIT/CPOE system or software failures. These contracts may also include “gag orders,” which prohibit health care providers from disclosing system flaws and software defects.

Furthermore, it was also reported to me that there is no system in place to track, monitor and report the performance of these systems/devices, which could impact a health care provider’s ability to make informed decisions regarding the implementation of an HIT/CPOE system.

…American taxpayers will be investing substantially in the HIT/CPOE industry, and it is important that their monies are appropriately spent on effective and interoperable HIT systems and devices. Accordingly, I would appreciate your response to the following questions and requests for information and documents…

…2) Does 3M include language in its contracts that could be considered “Hold Harmless” provisions? If so, please provide a copy of sample contracts with such provisions.
3) Does 3M incorporate the “learned intermediaries” doctrine in the HIT/CPOE contract? If so, please provide a copy of sample contracts with such language.

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http://www.nytimes.com/2009/12/08/health/policy/08grassley.html

Grassley Seeks Details on Medical Financing

By GARDINER HARRIS
Published: December 7, 2009

A top Republican senator, Charles E. Grassley, has sent letters to the American Medical Association, the American Cancer Society and 31 other disease and medical advocacy organizations asking them to provide details about the amount of money that they and their directors receive from drug and device makers.

Senator Charles E. Grassley has been studying the influence of drug and device makers on the medical profession.

Such financing amounts are often considered proprietary by the organizations and their directors, but critics contend that the industry’s sway over such groups leads them to lobby on the industry’s behalf.

Mike Lynch, a spokesman for the A.M.A., said the organization had received the senator’s letter and would respond. Mr. Lynch said industry financing made up less than 2 percent of the organization’s budget.

Steve Weiss, a spokesman for the American Cancer Society, sent an e-mail message stating that the society “holds itself to the highest standards of transparency and public accountability, and we look forward to working with Senator Grassley to provide the information he requested.”

Kate Meyer, a spokeswoman for the Alzheimer’s Association, which also received a letter from the senator, said the organization “was going to answer all of his questions,” but she would not immediately say what share of the organization’s financing comes from drug or device makers.

The letter is part of Mr. Grassley’s long-running investigation into the influence of drug and device makers on the practice of medicine. Mr. Grassley, an Iowa Republican, has also long been interested in how charities get and spend their tax-deductible contributions.

“These organizations have a lot of influence over public policy, and people rely on their leadership,” he said. “There’s a strong case for disclosure and the accountability that results.”

Earlier this year, Mr. Grassley sent a similar letter to the National Alliance on Mental Illness. The group told the senator that more than two-thirds of its donations came from the pharmaceutical industry. In response to the disclosure, Dr. H. Richard Lamb resigned from the group’s board.

Dr. Lamb joined the board of the organization in 2005, when he was “shocked to learn that approximately half of NAMI’s income comes from the large pharmaceutical companies,” he wrote in a resignation letter that Mr. Grassley made public. Alliance officials assured Dr. Lamb that the situation would change. “However,” Dr. Lamb wrote, “very little has changed, right up to the present day.” In an interview, Dr. Lamb said that NAMI’s dependence on the drug industry made some actions impossible. For instance, Dr. Lamb said that NAMI should consider warning against the use of some mental health drugs with life-threatening side effects. But Dr. Lamb said the organization could not consider such a move because it could threaten much of its financing.

Michael J. Fitzpatrick, the organization’s executive director, promised that the industry’s share of the group’s fund-raising would drop significantly next year.

Mr. Grassley’s request that organizations provide details about the outside income of directors may cause some consternation. While a few large patient advocacy groups have provided general guidance about their reliance on industry, almost none have given such details about their leaders.

A version of this article appeared in print on December 8, 2009, on page A27 of the New York edition.

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[WSJ's HealthBlog] Chuck Grassley’s Greatest Health-Care Hits

http://blogs.wsj.com/health/2009/12/08/chuck-grassleys-greatest-health-care-hits/

By Jacob Goldstein

Chuck GrassleySen. Chuck Grassley has been following the money in health care for years now. Yesterday, he  wrote to the AMA, the American Cancer Society and a bunch of other nonprofit advocacy groups to ask how much of their funding comes from the drug, device and insurance industries. [See letter at http://online.wsj.com/public/resources/documents/grassley110709.pdf]

The groups, which told the WSJ they plan to respond to the letters, have plenty of company. Here’s a quick list of some of the other Grassley pen pals. (For more, including responses from the people on the other end of the letters, follow the links in the items below.)

* Nonprofit hospitals: Grassley has said some facilities may be “losing sight of the public service that comes with tax-exempt status.” [http://blogs.wsj.com/health/2008/09/05/sen-grassley-keeps-pressure-on-non-profit-hospitals/]

* Medical Schools: He’s asked questions about industry payments to high-profile docs at medical schools including Emory, Harvard and Stanford. And just yesterday he wrote to UC San Francisco about financial issues.

* The FDA: It looked like a device maker was “calling the shots” at FDA, Grassley said.

* Health IT companies: Among other things, Grassley asked the companies to send him copies of “complaints and/or concerns” that health-care providers have expressed about the systems. [http://blogs.wsj.com/health/2009/10/26/chuck-grassley-has-a-few-questions-for-the-health-it-industry/]

Drug and Device Makers: On many, many, many occasions.

Letter to NIH: fund ethics research.

November 19th, 2009 No comments

http://www.pharmedout.org/
http://www.pharmedout.org/NIHLetter.pdf

November 17, 2009

Francis S. Collins, MD, PhD
Director
National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892

Dear Dr. Collins,

We are writing to ask NIH to fund studies on medical ethics, conflicts of interest in medicine and research, and prescribing behavior. NIH funds a substantial portion of the generation and dissemination of evidence, but the uptake of that evidence and its translation into clinical practice is strongly affected by the complex web of relationships that exists among industry, academicians, medical educators and clinicians.

There is growing evidence that each strand of this web is compromised by ethical lapses and financial conflicts of interest. The recent disclosure of ghostwritten articles, physician payoffs, and the use of academic opinion leaders to increase markets for FDA-regulated products indicate that ethical lapses may permeate biomedical research.

A PLoS Medicine editorial in September called ghostwriting “The dirty little secret of medical publishing” and notes “the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.” An October 1 editorial in the Boston Globe called for a ban on industry speaker fees to physicians. Last month, a commentary in JAMA called for physicians to pay for continuing medical education (CME), citing a recent Institute of Medicine report that criticized physicians’ reliance on industry-funded education.

A stated goal of the NIH is to “exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.” Could the muted effect that large, definitive NIH studies, including the WHI, ALLHAT, and CATIE, have had on clinical practice be due to commercial influences? To what extent have ghostwritten articles corrupted the medical and scientific literature? The extent to which industry influences the interpretation of science is unknown.

Dr. Elias Zerhouni, in the September 17th issue of Nature, commenting on Senator Grassley’s investigation of academic medical centers, said “People flouted the rules, didn’t disclose, and did it for years on end, repeatedly.”

In your role as the director of “the steward of medical and behavioral research for the Nation,” we ask that you acknowledge the research gap on the effect of conflicts of interest and commercial influence on medical decisionmaking and set in motion a process that leads to recognition of the importance of funding studies on research ethics, the beliefs and behaviors of researchers and clinicians, and the effects of industry-academic relationships on the generation and dissemination of medical knowledge.

Between bench and bedside lies a path treacherous with ethical quandaries. NIH is the best place to launch and support a scientifically rigorous inquiry into the state of research ethics, industry-academic relationships, and the effect of these relationships on human health. There is currently no identifiable mechanism through which NIH would fund this research.

Your leadership regarding the importance of this issue as one the NIH needs to direct resources towards is essential. We hope to discuss these issues in a face-to-face meeting.

Sincerely,

Adriane Fugh-Berman, MD
Associate Professor, Georgetown University Medical Center
Director, PharmedOut

.. and dozens of other signataries.

Also see:

http://www.pharmedout.org/NoDrugRepsCertificate.pdf

http://www.pharmedout.org/bingofunwithpharmads.pdf

Categories: Fighting for Health, Open Access Tags:

Five US universities to provide central funding for open access publication fees.

September 23rd, 2009 No comments

[Editor's Note]

This is a significant announcement in the promotion of Open Access. See http://www.openphi.com/about_open_access.html for more information on Open Access. HealthLibrarian (http://www.healthlibrarian.net/search/) already includes Open Access materials from all BioMed Central publications.

My team and I are currently developing the next generation of our software platform. Based exclusively on Free / Open Source Software, this platform is designed to crawl, parse, analyze and index massive amounts of information. Particularly Open Access materials.

By using domain-specific dictionaries we are then able to provide semantic search capabilities tailored to specific industries: health, legal, business, etc. Here is an overview of what we call Platv02: http://www.openphi.com/files/OpenPHI_PlatformV02.pdf

Give me a call at +1 (954) 553-1984 to discuss how our platform could extract knowledge from your organization’s content both quickly and cost-effectively.

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http://blogs.openaccesscentral.com/blogs/bmcblog/entry/five_us_universities_to_provide

Monday Sep 21, 2009

Five US universities to provide central funding for open access publication fees

In a major step forward for the open access movement, on September 15th 2009, Berkeley, Cornell, Dartmouth, Harvard and the Massachusetts Institute of Technology  announced a joint commitment to provide their researchers with central financial assistance to cover open access publication fees, and encouraged other academic institutions to join them.
Read more…

Categories: Open Access, Personalized Health Tags:

Palm Beach Community College Pilots HealthLibrarian.

September 4th, 2009 No comments

FOR IMMEDIATE RELEASE

Palm Beach Community College Pilots Semantic Search Engine for Health Knowledge.

Florida Startup Offers Multi-lingual Scientific, Open Access Health Content to 18,000 Students

August 25, 2009. (MIAMI, FLORIDA) – Palm Beach Community College (“PBCC”) is the first community college to join a pilot program to deploy the HealthLibrarian semantic search engine for health data across its campuses and accessible to all PBCC students and staff.

HealthLibrarian is different from traditional search engines: it does not blindly crawl the web, or present matches based on a site’s popularity. HealthLibrarian intelligently sorts and categorizes health-related information available from validated, academic, governmental and scientific sources in the so-called “Deep Web.” Users can then interactively fine-tune their query to maximize the relevance of the result set. The results presented are highly relevant and specific to the conditions or diseases of interest, and grouped by the geographical areas selected by the user. Visit http://www.HealthLibrarian.net/search to see HealthLibrarian in action now.
Read more…

Sens. Cornyn & Lieberman Team Up To Increase Public Access To Taxpayer Funded Research

July 28th, 2009 No comments

>> Announcement <<

Partners HealthCare’s Connected Health Symposium 2009
“Up from Crisis: Overhauling Healthcare Information, Payment and Delivery in Extraordinary Times”
Oct. 21- 22, 2009
The Boston Park Plaza and Towers, Boston, MA

Who’s speaking?  Presenters include:
* Nicholas Christakis, MD, PhD, MPH, Professor of Medical Sociology, Harvard Medical School, and TIME magazine’s 2009 choice, The World’s 100 Most Influential People; and co-author with James Fowler, PhD of Connected: The Surprising Power of Our Social Networks and How They Shape Our Lives.
* Jason Hwang, MD,  Executive Director of Healthcare, Innosight Institute, and co-author with Clayton Christensen, PhD, of The Innovators Prescription:  A Disruptive Solution for Health Care (2009).
* Stuart Altman, PhD, Professor of National Health Policy, The Heller Graduate School for Social Policy and Management, Brandeis University
* Angie Hicks, MBA, Founder and Chief Marketing Officer, Angies List
* Joseph Kvedar, MD, Director, Center for Connected Health, Partners HealthCare
* John Glaser, CIO, Partners HealthCare
* John Halamka, MD, CIO, CareGroup Health System; Dean for Technology at Harvard Medical School; Chair of the US Healthcare Information Technology Standards Panel (HITSP)

What’s up for discussion? Sessions include:
* The Amazing Effects on Health of Personal Social Networks – and How to Harness Their Power to Help Patients
* Payment Reform, the Role of Information Technology, and the Implications for IT Business Models
* Limits to the Wisdom of Patients and the Wisdom of Crowds?  Implications from Behavioral Economics
* Remote Monitoring in 2014: What’ll Be Different in Five Years about the Technology, the Data and the Incentives?
* Health Games: All Set to Play?
* Coordinating Care: What’s Really Involved and Who’s Really Going to Do It?

You’ll spend time with over 1,000 healthcare and technology leaders world-wide, from hospitals, clinics, home health agencies, large employers and health plans.  You’ll exchange ideas with tech entrepreneurs, business execs, investors, government officials and patient organization representatives.

Registration:
To all OpenPHI friends, Partners extends a special opportunity to register for October’s Symposium for $795; that is $100 off the regular rate. To obtain the discount, register as “general public” at http://www.connected-health.org and type in “PersonlizedHealth” in the invitation code box. Then continue the registration process until finished. For questions, feel free to contact Margaret Spinale at 617-643-3905 or mmspinale@partners.org.

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http://cornyn.senate.gov/public/index.cfm?FuseAction=ForPress.NewsReleases&ContentRecord_id=1959bcce-802a-23ad-4dbe-e2aece171fb3
Sens. Cornyn & Lieberman Team Up To Increase Public Access To Taxpayer Funded Research
Thursday, June 25, 2009

U.S. Sens. John Cornyn, R-Texas, and Joe Lieberman, I-CT, introduced legislation today to expand the public’s access to the research they help fund by shedding additional light on federal research projects.  Their legislation, the Federal Research Public Access Act (FRPAA), would require every federal department and agency with an annual extramural research budget of $100 million or more to make their research available to the public within six months of publication.
Read more…

Categories: Open Access Tags:

Student Statement on The Right to Research.

July 8th, 2009 No comments

[Jose's note:]

I will be in Washington, DC from July 20th until the 22nd. Let me know if you will be in the area and we can get together then.

I’ll exhibit my company’s data mining, bio-informatics and semantic search services at the 2009 caBIG Conference (https://cabig.nci.nih.gov/2009AnnualMeeting).

Registration is free, and the program looks very interesting. I’m looking forward to seeing you then.

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http://www.righttoresearch.org/

Student Statement on The Right to Research

Scholarly knowledge is part of the common wealth of humanity.

Unfortunately, not everyone has access to the scholarly literature, despite advances in communications technology.  The high cost of academic journals restricts access to knowledge; in some fields, prices can reach $20,000 for a single journal subscription [Note 01] or $30 for an individual article. [Note 02]  Despite these high prices, authors of scholarly articles are not paid for their work. The profits from these publications go solely to the publishers of the journals.  A vast amount of research is funded from public sources – yet taxpayers are locked out by the cost of access.
Learning and inquiry are impeded when scholars lack access to fellow researchers’ work, and when students lack access to the work of scholars before them.

At the same time, digital technologies have opened new opportunities for research. New tools facilitate faster discoveries, speed the development of new technologies, and accelerate the progress of science. Patients could have access to the latest medical research, citizens could evaluate scientific information on environmental impacts, and developing countries could apply the most recent scholarship to public health and development efforts.[Note 03] But access barriers leave these opportunities under-explored.

Open Access is an alternative to the traditional closed, subscription-access system of scholarly communication. Open Access makes the results of scholarly research available online for free, immediately upon publication, and removes barriers for scholarly and educational re-use.[Note 04] Entire journals can be open-access, or an author can provide Open Access to an individual article by posting a copy on an openly accessible Web site. All forms of open-access publication depend on rigorous methods of quality control, including peer review.

Open Access has achieved remarkable success to date: more than 4,000 open-access journals are published today;[Note 05] millions of articles are made available via open-access repositories;[Note 06] and dozens of policies from universities and research funders support Open Access;[Note 07] but still more needs to be done.

We, the undersigned student organizations, hereby endorse Open Access as the preferred model for scholarly communication, because:

(a) Open Access improves the educational experience. All students, regardless of their institution’s ability to afford subscriptions, should have access to the full scholarly record, whether for assigned reading, research for a term paper, or literature review for a dissertation.

(b) Open Access democratizes access to research. Students from around the world should have full access to the scholarly literature, along with patients looking for medical information and citizens seeking to learn about the environment or other scientific topics.

(c) Open Access advances research. Open Access helps researchers be more productive by facilitating access to the latest studies. Open Access also enables new techniques for computer-assisted research, paving the way for scientific advancements.

(d) Open Access improves the visibility and impact of scholarship. Today’s student is tomorrow’s scholar. Recent studies suggest that Open Access articles are downloaded and cited more frequently than articles that are accessible only through subscription.[Note 08] Open Access fulfills researchers’ professional responsibility to maximize the impact of their research.

We hereby:

Call upon UNIVERSITIES to support Open Access

We believe universities should adopt policies that ensure Open Access to their faculty’s research, such as the policies adopted at Harvard University[Note 09] and Stanford University.[Note 10]

Call upon GOVERNMENTS AND RESEARCH FUNDERS to support Open Access

We believe research agencies should adopt policies that ensure Open Access to publicly funded research, such as that of the National Institutes of Health[Note 11] and the Canadian Institutes of Health Research.[Note 12]

We believe charitable funders likewise should adopt policies that ensure Open Access to their funded research, such as that of Autism Speaks[Note 13] and the Canadian Cancer Society.[Note 14]

Call upon RESEARCHERS to support Open Access

We believe researchers should publish in Open Access journals, and/or deposit their peer-reviewed manuscripts in Open Access repositories.[Note 15]

Commit to support Open Access in our activities

We will undertake activities, in our membership and on our campuses, to educate students about Open Access and to engage them in efforts supporting Open Access.

American Medical Student Association (June 10, 2009)
Student PIRGs (June 10, 2009)
Students for Free Culture (June 10, 2009)
Universities Allied for Essential Medicines (June 10, 2009)
California Institute of Technology Graduate Student Council (June 10, 2009)
Trinity University Association of Student Representatives (June 10, 2009)

Notes

01. The cost of an institutional subscription to Brain Research in 2009 was $22,940 (http://www.elsevier.com/wps/find/journaldescription.cws_home/622287/bibliographic).
02. The price per article for Elsevier journals on ScienceDirect is $31.50 as of March 4, 2009 (http://www.info.sciencedirect.com/licensing/individual/ppv/).
03. World Health Assembly resolution 61.21, “Global strategy and plan of action on public health, innovation and intellectual property,” adopted May 24, 2008 (http://www.who.int/gb/ebwha/pdf_files/A61/A61_R21-en.pdf).
04. As defined in the Budapest Open Access Initiative, the Bethesda Statement on Open Access Publishing, and the Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities (http://www.soros.org/openaccess/read.shtml; http://www.earlham.edu/~peters/fos/bethesda.htm; http://oa.mpg.de/openaccess-berlin/berlindeclaration.html).
05. The Directory of Open Access Journals lists 4,103 journals as of May 1, 2009 (http://www.doaj.org/).
06. According to statistics published in the Open Access Directory (http://oad.simmons.edu/oadwiki/OA_by_the_numbers).
07. According to the Registry of Open Access Repository Material Archiving Policies (http://www.eprints.org/openaccess/policysignup/).
08. “The effect of open access and downloads (‘hits’) on citation impact: a bibliography of studies”, Open Citation Project (http://opcit.eprints.org/oacitation-biblio.html).
09. “The Harvard Open-Access Policies,” Harvard University Library Office for Scholarly Communications (http://osc.hul.harvard.edu/OpenAccess/overview.php).
10. “Stanford University School of Education Open Access Motion” (http://ed.stanford.edu/suse/faculty/openaccess.html).
11. “Public Access Policy”, National Institutes of Health (http://publicaccess.nih.gov/policy.htm).
12. “Policy on Access to Research Outputs”, Canadian Institutes of Health Research (http://www.cihr-irsc.gc.ca/e/34846.html).
13. “Policy on Public Access to the Research We Fund,” Autism Speaks (http://www.autismspeaks.org/science/overview/policies/policy_on_public_access_to_research.php).
14. “Open access policy”, Canadian Cancer Society (http://cancer.ca/research/policies and administration/policy/open access.aspx).
15. Peter Suber, “Six things that researchers need to know about open access”, SPARC Open Access Newsletter, February 2, 2006 (http://www.earlham.edu/~peters/fos/newsletter/02-02-06.htm#know).

Categories: Open Access Tags:

Free Search of Medicare’s National Provider Identifier Numbers.

May 18th, 2009 No comments

Free Search of Medicare’s National Provider Identifier Numbers

Search Engine Startup Makes CMS NPI Data Accessible to Consumers, Healthcare Professionals

Miami, Florida. May 18, 2009. HealthLibrarian (www.HealthLibrarian.net) announces the immediate availability, at no cost, of the Center for Medicare and Medicaid’s (“CMS”) National Provider Identifier (“NPI”) database through our website. Visitors can search the CMS NPI database through an easy-to-use web interface by entering the state, county, city, name, or specialty of the healthcare provider of interest.

The NPI is a Health Insurance Portability and Accountability Act (“HIPAA”) Administrative Simplification Standard. The NPI is a unique identification number for covered health care providers. Covered health care providers and all health plans and health care clearinghouses will use the NPIs in the administrative and financial  transactions adopted under HIPAA. All health care providers who bill CMS for services need to have an NPI.

HealthLibrarian enriched the NPI database to allow users to search by “specialty”field, indexed using the Healthcare Provider Taxonomy Codes. This code set divides health care providers into hierarchical groupings by type, classification, and specialization, and assigns a code to each grouping. The Taxonomy consists of two parts: individuals (e.g., physicians) and non-individuals (e.g., ambulatory health care facilities). Visitors to HealthLibrarian can find Medicare providers in their local community by specialty, from “Acupuncturist”, “Acute Care”, “Addiction (Substance Use Disorder)”to “Women’s Health Care, Ambulatory”, and “Wound Care”.

“This data comes right out of Medicare,” said Jose C. Lacal, Chief Vision Officer of HealthLibrarian. “OpenPHI has physically downloaded the NPI data files and loaded them into our Data Warehouse. We indexed all the information against our Controlled Medical Vocabulary, and developed a user-friendly interface to search the NPI file. And we added cross-references to other government data sources to enhance the value of the NPI database.”

OpenPHI also licenses customized contact lists (mailing address, telephone / fax numbers) of Medicare providers. Contact us to create a customized NPI mailing list based on your specific needs, by geography, or by specialty.

Source of Information
The NPI database is maintained by the Centers for Medicare and Medicaid Services. The raw data (03 Gb) is available at http://nppesdata.cms.hhs.gov/cms_NPI_files.html

Controlled Medical Vocabulary (“CMV”)
HealthLibrarian uses “semantic matching” to show user a list of medically-related terms. Searching for “heart” will also include “cardiac.” Our CMV has over 07 Million entries.

Available for License
We can easily integrate HealthLibrarian with your website or healthcare application.

About Jose C. Lacal
Jose has over 25 years experience working for huge multinationals (07 years at Motorola, 03 at Siemens) and as a serial entrepreneur. He’s passionate about Health Information Technology (“Health IT”); Free / Open Source Software (i.e. GNU/Linux, Apache); and data-mining the “Deep Web” of health data. Jose is available for interviews as well as speaking engagements, both in English and Spanish.

About HealthLibrarian
HealthLibrarian is an On-demand Data Warehouse of Global Health-related Insight. Our turn-key appliance integrates search, data mining, web crawling and indexing of health data from validated global sources. HealthLibrarian is different from traditional search engines. We do not blindly crawl the web, or present matches based on a site’s popularity. HealthLibrarian intelligently sorts and categorizes health-related information available from validated, governmental and scientific sources. Users can then interactively fine-tune their query to maximize the relevance of the result set. The results presented are highly relevant and specific to the conditions or diseases of interest. These results are grouped by the geographical areas selected by the user.

HealthLibrarian is a service of Open Personalized Health Informatics, Corp. (“OpenPHI”), a self-funded, privately-held bio-informatics startup in sunny Miami, Florida.

While some try to “improve the healthcare system,” we focus on building a care system that improves our health. We call that “Personalized Health.” OpenPHI simplifies the use of the vast amount of health databases, publications, and medical know-how freely available from academic and government sources across the world.

Elsevier published 06 fake “scientific journals” for Merck and others.

May 13th, 2009 No comments

[Jose's Note: What started as a report of Elsevier publishing a fake scientific journal for Merck has now expanded to Elsevier acknowledging the publication of at least six such fake journals.]

..The first fun thing to emerge in the Australian case is email documentation showing staff at Merck made a “hit list” of doctors who were critical of the company, or of the drug. This list contained words such as “neutralise”, “neutralised” and “discredit” next to the names of various doctors.
“We may need to seek them out and destroy them where they live,” said one email, from a Merck employee. Staff are also alleged to have used other tactics, such as trying to interfere with academic appointments, and dropping hints about how funding to institutions might dry up. Institutions might think about whether they wish to receive money from a company like that in future. Worse still, is the revelation that Merck paid the publisher Elsevier to produce a publication.

..The real tragedy is that the cost of distorted information, and irrational prescribing, is far greater than the cost of the research that could prevent it. Health systems pay for these drugs – state-funded in almost every single developed country – and they largely pay for the journals, too. In a sensible world, countries would band together and pay for comparative research themselves, and the free, open distribution of the results, to prevent all this nonsense.

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http://www.the-scientist.com/blog/display/55679/

Elsevier published 6 fake journals
Posted by Bob Grant

[Entry posted at 7th May 2009 04:27 PM GMT]

Scientific publishing giant Elsevier put out a total of six publications between 2000 and 2005 that were sponsored by unnamed pharmaceutical companies and looked like peer reviewed medical journals, but did not disclose sponsorship, the company has admitted.

Elsevier is conducting an “internal review” of its publishing practices after allegations came to light that the company produced a pharmaceutical company-funded publication in the early 2000s without disclosing that the “journal” was corporate sponsored.

The allegations involve the Australasian Journal of Bone and Joint Medicine, a publication paid for by pharmaceutical company Merck that amounted to a compendium of reprinted scientific articles and one-source reviews, most of which presented data favorable to Merck’s products. The Scientist obtained two 2003 issues of the journal –which bore the imprint of Elsevier’s Excerpta Medica– neither of which carried a statement obviating Merck’s sponsorship of the publication.

An Elsevier spokesperson told The Scientist in an email that a total of six titles in a “series of sponsored article publications” were put out by their Australia office and bore the Excerpta Medica imprint from 2000 to 2005. These titles were: the Australasian Journal of General Practice, the Australasian Journal of Neurology, the Australasian Journal of Cardiology, the Australasian Journal of Clinical Pharmacy, the Australasian Journal of Cardiovascular Medicine, and the Australasian Journal of Bone & Joint [Medicine]. Elsevier declined to provide the names of the sponsors of these titles, according to the company spokesperson.

“It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures,” said Michael Hansen, CEO of Elsevier’s Health Sciences Division, in a statement issued by the company. “This was an unacceptable practice, and we regret that it took place.” {Full statement at http://www.elsevier.com/wps/find/authored_newsitem.cws_home/companynews05_01203}

When confronted with the questionable publishing practices surrounding the Australasian Journal of Bone and Joint Medicine last week, Elsevier indicated that it had no plans of looking into the matter further, but that decision has apparently been reversed.

“We are currently conducting an internal review but believe this was an isolated practice from a past period in time,” Hansen continued in the Elsevier statement. “It does not reflect the way we operate today. The individuals involved in the project have long since left the company. I have affirmed our business practices as they relate to what defines a journal and the proper use of disclosure language with our employees to ensure this does not happen again.”

“I understand this issue has troubled our communities of authors, editors, customers and employees,” Hansen added in the statement. “But I can assure all that the integrity of Elsevier’s publications and business practices remains intact.”

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Merck Makes Phony Peer-Review Journal

http://blog.bioethics.net/2009/05/merck-makes-phony-peerreview-journal/
http://www.elsevier.com/wps/find/authored_newsitem.cws_home/companynews05_01203
It’s a safe guess that somewhere at Merck today someone is going through the meeting minutes of the day that the hair-brained scheme for the Australasian Journal of Bone and Joint Medicine was launched, and that everyone who was in the room is now going to be fired.

The Scientist has reported that, yes, it’s true, Merck cooked up a phony, but real sounding, peer reviewed journal and published favorably looking data for its products in them. Merck paid Elsevier to publish such a tome, which neither appears in MEDLINE or has a website, according to The Scientist.

What’s wrong with this is so obvious it doesn’t have to be argued for. What’s sad is that I’m sure many a primary care physician was given literature from Merck that said, “As published in Australasian Journal of Bone and Joint Medicine, Fosamax outperforms all other medications….” Said doctor, or even the average researcher wouldn’t know that the journal is bogus. In fact, knowing that the journal is published by Elsevier gives it credibility!

These kinds of endeavors are not possible without help. One of The Scientist’s most notable finds is a Australian rheumatologist named Peter Brooks who served on the “honorary advisory board” of this “journal”. His take: “I don’t think it’s fair to say it was totally a marketing journal”, apparently on the grounds that it had excerpts from peer-reviewed papers. However, in his entire time on the board he never received a single paper for peer-review, but because he apparently knew the journal did not receive original submissions of research. This didn’t seem to bother him one bit. Such “throwaways” of non-peer reviewed publications and semi-marketing materials are commonplace in medicine. But wouldn’t that seem odd for an academic journal? Apparently not. Moreover, Peter Brooks had a pretty lax sense of academic ethics any way: he admitted to having his name put on a “advertorial” for pharma within the last ten years, says The Scientist. An “advertorial”? Again, language unfamiliar to us in the academic publishing world, but apparently quite familiar to the pharmaceutical publishing scene.

It is this attitude within companies like Merck and among doctors that allows scandals precisely like this to happen. While the scandals with Merck and Vioxx are particularly egregious, we know they are not isolated incidents. This one is just particularly so. If physicians would not lend their names or pens to these efforts, and publishers would not offer their presses, these publications could not exist. What doctors would have as available data would be peer-reviewed research and what pharmaceutical companies produce from their marketing departments–actual advertisements.

Summer Johnson, PhD

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http://www.guardian.co.uk/commentisfree/2009/may/09/bad-science-medical-journals-companies

The danger of drugs – and data

* Ben Goldacre
* The Guardian, Saturday 9 May 2009

A fascinating court case in Australia has been playing out around some people who had heart attacks after taking the Merck drug ­Vioxx. This medication turned out to increase the risk of heart attacks in people taking it, although that finding was arguably buried in their research, and Merck has paid out more than £2bn to 44,000 people in America – however, they deny any fault.

British users of the drug have had their application for legal aid rejected, incidentally: the health minister, Ivan Lewis, promised to help them, but documents obtained by the Guardian last week showed that within hours Merck launched an expensive lobbying effort that convinced the minister to back off.

This is a shame, because court cases can be tremendously revealing.

The first fun thing to emerge in the Australian case is email documentation showing staff at Merck made a “hit list” of doctors who were critical of the company, or of the drug. This list contained words such as “neutralise”, “neutralised” and “discredit” next to the names of various doctors.

“We may need to seek them out and destroy them where they live,” said one email, from a Merck employee. Staff are also alleged to have used other tactics, such as trying to interfere with academic appointments, and dropping hints about how funding to institutions might dry up. Institutions might think about whether they wish to receive money from a company like that in future. Worse still, is the revelation that Merck paid the publisher Elsevier to produce a publication.

The relationship between big pharma and publishers is perilous. Any industry with global revenues of $600bn can afford to buy quite a lot of adverts, and pharmaceutical companies also buy glossy expensive “reprints” of the trials it feels flattered by. As we noted in this column two months ago, there is evidence that all this money distorts editorial decisions.

This time Elsevier Australia went the whole hog, giving Merck an entire publication which resembled an academic journal, although in fact it only contained reprinted articles, or summaries, of other articles. In issue 2, for example, nine of the 29 articles concerned Vioxx, and a dozen of the remainder were about another Merck drug, Fosamax. All of these articles presented positive conclusions. Some were bizarre: such as a review article containing just two references.

In a statement to The Scientist magazine, Elsevier at first said the company “does not today consider a compilation of reprinted articles a ‘journal’”. I would like to expand on this ­statement: It was a collection of academic journal articles, published by the academic journal publisher Elsevier, in an academic ­journal-shaped package. Perhaps if it wasn’t an academic journal they could have made this clearer in the title which, I should have mentioned, was named: The Australasian Journal of Bone and Joint Medicine.

Things have deteriorated since. It turns out that Elsevier put out six such journals, sponsored by industry. The Elsevier chief executive, Michael Hansen, has now admitted that they were made to look like journals, and lacked proper disclosure. “This was an unacceptable practice and we regret that it took place,” he said.

The pharmaceutical industry, and publishers, as we have repeatedly seen, have serious difficulties in living up to the high standards needed in this field, and bad information in the medical literature leads doctors to make irrational prescribing decisions, which ultimately can cost lives, and cause unnecessary suffering, not to mention the expense.

It has been estimated it would take 700 hours a month to read the thousands of academic articles relevant to a GP; doctors skim, they take shortcuts, they rely on summaries, or worse. We could perform better when giving them information, but for now, it will often be “actually, I think I’ve seen at least two studies on that, and in different journals”.

The real tragedy is that the cost of distorted information, and irrational prescribing, is far greater than the cost of the research that could prevent it. Health systems pay for these drugs – state-funded in almost every single developed country – and they largely pay for the journals, too. In a sensible world, countries would band together and pay for comparative research themselves, and the free, open distribution of the results, to prevent all this nonsense.

We do not live in a sensible world.

Categories: Fighting for Health, Open Access Tags:

First Website to Search Adverse Event Reports of Drugs, Medications.

April 28th, 2009 No comments

Media Contact:
Jose C. Lacal
Jose.Lacal@HealthLibrarian.net
+1 (954) 553-1984 (EST: GMT – 05)

First Website to Search Adverse Event Reports of Drugs, Medications

Search Engine Startup Makes FDA Drug Data Accessible to Consumers, Healthcare Professionals

Miami, Florida. April 28, 2009. HealthLibrarian (www.HealthLibrarian.net) announces the immediate availability, at no cost, of the Food and Drug Administration’s Adverse Event Reporting System (“AERS”) database through our website. See http://www.healthlibrarian.net/us/hhs/fda/adverse_events_drugs/home.html

Consumers and healthcare professionals can search the AERS database from an easy-to-use web interface by entering the name of a drug or medication of interest. AERS is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The ultimate goal of AERS is to improve the public health by providing the best available tools for storing and analyzing safety reports.

The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products. “This data comes right out of the FDA, where drug manufacturers regularly file adverse reports for drugs sold in the US,” said Jose C. Lacal, Chief Vision Officer of HealthLibrarian. “This data required significant processing to make it usable and searchable. This is part of HealthLibrarian’s expanding list of academic and government databases of health data available at no charge through a single website, http://www.HealthLibrarian.net”

Consumers as well as healthcare providers should visit HealthLibrarian often to:
* Search adverse drug reports in a single place
* Find detailed information for each drug report
* View events reported by international reporting agencies
* Report your own adverse event to the FDA through the provided links

The ICH Guideline entitled “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting” defines serious adverse events as follows: “A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.” (See: http://www.fda.gov/cder/guidance/iche3.pdf page 25).

Source of Information
The AERS database is maintained by the Food and Drug Administration. The raw data files (52MB for 01 year) are available at http://www.fda.gov/cder/aers/default.htm

Controlled Medical Vocabulary (“CMV”)
HealthLibrarian uses “semantic matching” to show user a list of medically-related terms. Searching for “heart” will also include “cardiac.” Our CMV has over 07 Million entries.

Available for License
We can easily integrate HealthLibrarian with your website or healthcare application.

About Jose C. Lacal
Jose has over 25 years experience working for huge multinationals (07 years at Motorola, 03 at Siemens) and as a serial entrepreneur. He’s passionate about Health Information Technology (“Health IT”); Free / Open Source Software (i.e. GNU/Linux, Apache); and data-mining the “Deep Web” of health data. Jose is available for interviews as well as speaking engagements, both in English and Spanish.

About HealthLibrarian
HealthLibrarian is an On-demand Data Warehouse of Global Health-related Insight.
Our turn-key appliance integrates search, data mining, web crawling and indexing of health data from validated global sources. HealthLibrarian is different from traditional search engines. We do not blindly crawl the web, or present matches based on a site’s popularity. HealthLibrarian intelligently sorts and categorizes health-related information available from validated, governmental and scientific sources. Users can then interactively fine-tune their query to maximize the relevance of the result set. The results presented are highly relevant and specific to the conditions or diseases of interest. These results are grouped by the geographical areas selected by the user.

HealthLibrarian is a service of Open Personalized Health Informatics, Corp. (“OpenPHI”), a self-funded, privately-held bio-informatics startup in sunny Miami, Florida.

While some try to “improve the healthcare system,” we focus on building a care system that improves our health. We call that “Personalized Health.” OpenPHI simplifies the use of the vast amount of health databases, publications, and medical know-how freely available from academic and government sources across the world.

Categories: Open Access, Personalized Health Tags: