29/09/2009 by admin.

NEW YORK (AdAge.com) — The U.S. Food and Drug Administration will hold a two-day public hearing in November on how pharmaceutical companies use the web and social-media tools to market their products, the first step in a long overdue process that will finally establish guidelines for how drug makers proceed in a Web 2.0 world.

The industry is embracing the news, despite the newfound regulatory heavy hand the FDA has shown under the Obama administration. “It’s about time,” said an executive for one top-five pharmaceutical company who asked not to be identified. “Any guidance at all is better than having no guidance, which is what we have right now.”

Regulatory guidelines are now sorely lacking for direct-to-consumer spending by pharmaceutical companies using internet media. While overall DTC spending fell to $4.7 billion in 2008, a 10.6% drop according to TNS Media Intelligence, internet spending by drug makers zoomed 36% to $137 million — a modest output, but, again, a figure that was likely hampered by a lack of regulation and a fear of FDA retribution. It also does not account for web video, social media and other forms of marketing being increasingly embraced by the industry.

http://adage.com/results?endeca=1&return=endeca&search_offset=0&search_order_by=score&search_phrase=09/23/2009>

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29/09/2009 by admin.

http://www.pharmainfocus.com.au/news.asp?newsid=2953

Posted 28 September 2009

Wyeth spent over $1 million on a single Australian weekend meeting on
antidpressants in March this year shortly after the PBS listing of its
new SSRI, Pristiq (desvenlafaxine) say new Medicines Australia (MA)
records for spending on sponsored events.

The company, which is continuing to mount a so far successful defence of
its remaining patents on Australia’s biggest selling antidepressant
Efexor-XR (venlafaxine), described the event as a “new anti-depressant
overview weekend meeting” and said the money was spent on venue hire,
hospitality, speaker fees, accommodations and flights and various
technical support and event management fees.

The occasion was a standout among 16,020 events sponsored by MA member
companies over the six months from 1 January to 30 June 2009 at a total
cost of $31.89 million, $15.65 million of which was spent on hospitality
(an average of $39.22 per attendee). Total spending is a slight jump
from the second half of 2008, which came in at just over $30 million,
but down from the first half of 2008, at $32.6 million

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29/09/2009 by admin.

http://www.pharmainfocus.com.au/opinion.asp?opinionid=278

Last week was an important one for watchers of the continuing debate
over pharmaceutical industry influence on medical and healthcare
professionals. Developments overseas and in Australia showed that the
march towards greater transparency is gaining pace.

In the US, Merck has added its name to the list of major pharma
companies that have voluntarily decided to publish payments made to
doctors on their corporate websites.

It joins Pfizer, Eli Lilly and GlaxoSmithKline in either disclosing or
pledging to disclose payments for such activities as consulting,
speaking and writing. GSK has also said it will cap payments at US
$150,000 to any one doctor.

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23/09/2009 by admin.

GSK has changed its policy on continuing medical education (CME) and will fund less, and only independent sessions with balanced information.

Read more at http://www.washingtonpost.com/wp-dyn/content/article/2009/09/21/AR2009092101342.html

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22/09/2009 by admin.

A very informative website to search for fraudulently promoted drugs

http://www.usdoj.gov/opa/pr/2009/September/09-aag-900.htm

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22/09/2009 by admin.

Former US defence secretary Donald Rumsfeld was talking about weapons of mass destruction and the war in Iraq when he referred to “unknown unknowns” in 2002, but he could just as easily have been explaining why drug companies have been able to make money out of the global flu pandemic. Within a few months of his comments, a series of events began to fuel growing international concern about a new pandemic. The mixture of fear and ignorance over its timing, nature, and severity soon sparked an unexpected bonanza for the manufacturers.

Since the emergence of swine flu in Mexico this spring finally triggered the first pandemic in four decades, J P Morgan, the investment bank, estimates that governments have made fresh orders for antiviral drugs of $3bn (£1.8bn; 2bn) and that recent or potential sales of vaccines are $7bn.1 All that despite signs that the virus is proving relatively mild, with potentially less impact than a standard seasonal flu outbreak.

One beneficiary has been Gilead, a fast growing US biotech business that initially developed the antiviral medicine oseltamivir (Tamiflu). In the three months to June this year alone it reported $52m in royalties on its drug. Another who gained was Rumsfeld, Gilead’s former chairman and continuing shareholder, who stressed that he disqualified himself from decisions that could have caused conflicts of interest.2

Read the full story at http://www.bmj.com/cgi/content/full/339/sep18_2/b3811

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21/09/2009 by admin.

The recent buzz of coverage around the patent pool in the Guardian continues today with a letter to GSK and other Pharma companies from UNITAID.
Original article in the Guardian on 6th September drawing attention to the CEO letter to GSK’s Andrew Witty:

http://www.guardian.co.uk/business/2009/sep/06/glaxosmithkline-hiv-drugs-urged

The article reiterated in an online Pharma news site and the ‘Mail and Guardian’ South African newspaper:

http://www.fiercepharma.com/story/activists-ask-gsk-pool-hiv-patents/2009-09-08

http://www.mg.co.za/article/2009-09-07-glaxosmithkline-urged-to-pool-its-patents-on-hiv-drugs

GSK’s response regarding its engagement with UNITAID published in the Guardian on September 10th:

http://www.guardian.co.uk/business/2009/sep/10/glaxosmithkline-hiv-aids-patents

And then on the same day mentioned in the Katine blog:

http://www.guardian.co.uk/society/katineblog/2009/sep/10/news-health

Today- 15th September. A response from UNITAID published:

http://www.guardian.co.uk/theguardian/2009/sep/15/unitaid-aids-patent-pool

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18/09/2009 by admin.

The scientific integrity of medical research has been clouded in recent years by articles that were drafted by drug company-sponsored ghostwriters and then passed off as the work of independent academic authors.

Yet the leading medical journals have continued to rely largely on an honor system of disclosure to detect such potential bias, asking authors to voluntarily report any industry ties or contributors to their manuscripts.

But now, in light of recently released evidence that some drug makers have gone to great lengths to turn scientific articles into marketing vehicles for their products, some influential medical editors are cracking down on industry-financed ghostwriting. And they are getting help from some members of Congress.

http://www.nytimes.com/2009/09/18/business/18ghost.html?_r=2&adxnnl=1&ref=hea

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14/09/2009 by admin.

This week, two healthy skepticism members have written an interesting editorial in the Journal of Epidemiology and Community health on the impact of pharmaceutical advertising on doctor’s prescribing. Have a read at http://jech.bmj.com/cgi/content/short/63/10/773?q=w_jech_current_tab 13/9/9.

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11/09/2009 by admin.

WASHINGTON - Today U.S. Senate Special Committee on Aging Chairman Herb Kohl (D-WI) held a hearing on conflicts of interest in medical education.  In recent years, the pharmaceutical and medical device industries have increased their funding of Continuing Medical Education (CME), medical schools, and professional medical associations.  The industries also pay physicians directly for their service as educational consultants.  According to the Institute of Medicine, industry funding for accredited CME quadrupled from $302 million to $1.2 billion between 1998 and 2006.

“Large corporations do not typically spend these sums unless they think they will get something out of it,” said Chairman Kohl.  ”Are the drug and device industries getting a return on their annual billion dollar investment in medical education?  Do the programs funded by industry stay true to their mission of providing unbiased education and research, or do they instead market the industry’s latest products?  We are not suggesting that these financial relationships are rife with corruption, but it is clear to us that greater transparency, and perhaps stronger firewalls, should be considered.”

This influx of funding has raised concerns that CME and other medical educational activities, meant to keep doctors updated on the latest scientific advances and best practices in medicine, could be unduly influenced by the pharmaceutical and device industries.  The Aging Committee heard from a number of well-respected witnesses on the topic and considered recommendations for reform of the CME delivery system.  The hearing also brought attention to the ways in which some organizations are mitigating industry influence, while also enabling legitimate physician-industry relationships to flourish.

Senator Kohl, along with Senator Chuck Grassley (R-IA), is cosponsor of the Physician Payments Sunshine Act (S. 301), which would require the pharmaceutical and medical device industries to publicly report payments and gifts to doctors.  Recently, identical provisions to those in S.301 were included in the health care reform discussion documents released by the Senate Finance Committee.  Similar provisions were also included in the House tri-committee health reform bill, which also includes disclosure of industry payments to medical schools, sponsors of continuing medical education programs, and organizations of health care professionals.

The Committee first heard from Lewis Morris, representing the Office of Counsel to the Inspector General in the Department of Health and Human Services (HHS/OIG), who explained their ongoing assessment of conflicts of interest in medical education and outlined potential solutions for reducing the most egregious conflicts without damaging useful and legitimate programs. Next, Dr. Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, shared the results of a study published in the Journal of the American Medical Association (JAMA) that revealed the depth of the problem of industry-funded medical education and what steps he believes are necessary to rectify those problems.

Also on the first panel, Dr. Eric Campbell, Associate Professor at Harvard University, discussed the Institute of Medicine’s (IoM) recent study on conflict of interest in medical research, education, and practice.  Finally, Jack Rusley, a fourth year medical student and the Chair of the Culture of Medicine at the American Medical Student Association (AMSA) provided information on the AMSA Scorecard and its methodology for ranking medical schools’ policies on transparency in medical education, as well as his personal experience as a student advocate for reform.

On the second panel, Dr. Thomas Stossel, Professor at Harvard University and Director of Translational Medicine at Brigham Women’s Hospital, offered testimony concerning the newly formed Association of Clinical Researchers and Educators (ACRE), which contends that restricting industry funding of education programs would be counterproductive and may ultimately harm both patients and the practice of medicine.

Next, Dr. James Scully, Medical Director and CEO of the American Psychiatric Association (APA) spoke about the APA’s recently-altered policies and code of conduct on accepting industry funding for educational programs and research and the reasons for those changes.  Finally, Dr. Murray Kopelow, President of the Accreditation Council for Continuing Medical Education (ACCME), discussed ACCME’s role in standardizing CME delivery and monitoring potential problems therein.

read the full report at http://tinkerready.wordpress.com/2009/07/31/senate-hearing-industry-support-for-medical-education/

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