"“We have lent a huge amount of money to the U.S. Of course we are concerned about the safety of our assets. To be honest, I am definitely a little worried.” "

Chinese premier Wen Jiabao 12th March 2009

""We have a financial system that is run by private shareholders, managed by private institutions, and we'd like to do our best to preserve that system."

Timothy Geithner US Secretary of the Treasury, previously President of the Federal Reserve Bank of New York.1/3/2009

Friday, May 23, 2008

Lord Patel's favourite, Chuck Grassley is letting the Sun Shine in on Big Pharma - Lesson for Nu Labour

Charles "Chuck" Grassley is a hard working Baptist Iowan Senator, 74 years young but much admired from afar by Lord Patel as an independent tough talking and acting, rooter out of graft and log rolling.

Last September he introduced a quaintly labelled piece of legislation - S. 2029: Physician Payments Sunshine Act of 2007. This is a Bill that amends title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment (US$2.2 Trillion)is made under Medicare, Medicaid, or SCHIP.

Under this Bill, a searchable , online registry would be created to keep track of gifts, speaking fees, travel reimbursements and paid research agreements given to doctors. Any gifts or payments given to physicians that exceed $500 a year would have to be disclosed, as part of the bill. Penalties would range from $1000 to $50 000 per violation, with an annual limit of $250 000. The Bill also specifies that federal law would pre-empt state disclosure laws. The legislation requires the Secretary of Health and Human Services to create a website and post payment information in a clear and understandable manner.

Chuck has sponsored has sponsored 431 bills in his time of which 327 never made it out of committee , but he has had 26 Bills enacted - probably his most significant efforts were in steering through Congress in 2003 , the first-ever, comprehensive, voluntary Medicare prescription drug benefit legislation. The public health insurance program for seniors and disabled individuals now has 39 million beneficiaries who are enrolled in Part D.

US Pharma oozes US$19 Billion a year to prescribers ...

“Right now the public has no way to know whether a doctor’s been given money that might affect prescribing habits,” Chuck says. “This bill is about letting the sun shine in so that the public can know. Whether it’s dinner at a restaurant or tens of thousands of dollars or more in fees and travel, patients shouldn’t be in the dark about whether their doctors are getting money from drug and device makers.” Estimates indicate that the US drug industry spends US$19 billion annually on marketing to physicians in the form of gifts, travel, meals, and other ..er .... consulting fees.

A study by the Kaiser Family Foundation showed that industry spending on marketing to physicians increased from US$3.5 billion in 1996 to US$7.2 billion in 2005.

A study published last year by the New England Journal of Medicine found that more than three-quarters of doctors surveyed had taken free samples, free food or free tickets to sporting events from the drug industry. More than one-third had accepted free continuing education classes and another third had been paid speaking or consulting fees or for enrolling patients in clinical trials.

There has been a breaking of the log jam this week and it now looks as though the sun is shining on this Bill which is gettting some traction with support from Big Pharma .The Pharmaceutical Research and Manufacturers Association have now announced their support and AstraZeneca, Merck & Co, Medtronic , AdvaMed, Zimmer Holdings Inc , Association of American Medical Colleges and Eli Lilly have provided supportive voices.

The Advanced Medical Technology Association (AdvaMed) represents 1,600 medical technology innovators and manufacturers of medical devices, diagnostic products and medical information systems have also thrown their weight behind the Bill.

Tony Zook, CEO of AstraZeneca's US pharmaceutical operations said last week , this bill will ." create greater transparency around our relationships with physicians, while helping the public understand how we work with healthcare providers,"

In a letter sent to senators Richard Clark, PhRMA Chairman and Chairman and CEO, Merck & Co., Inc., yesterday they stated that their acceptance of the Bill which is conditioned on the continued inclusion of the provision that preempts state law and avoids a patchwork of State legislation. Already similar initiatives have been started in Minnesota, Vermont, Maine and West Virginia.

In June The American Medical Association's Council on Ethical and Judicial Affairs is expected to review new policies , currently AMA policy now discourages doctors from taking gifts or industry benefits of more than $100.

Big Pharma is getting the message companies may not need to change their practices, just to make them public.

AstraZeneca have made a commitment to enhancing our transparency and last year, decided to make public, medical education grants, contributions to non-profit organizations, political action committee contributions, and phase IV commitments. This will be posted to their website through 2008 alongside company policy positions, compliance program, and clinical trials more accessible on their external web site.

This month they have extended the scope of clinical trial disclosures to include information about the registration and results of all AstraZeneca sponsored clinical trials for all products in all phases, including marketed medicines, drugs in development, and drugs whose further development has been discontinued.

“The trust of our industry is deteriorating rapidly, and it undermines our business model,” said Eli Lilly spokesman Edward G. Sagebiel. “There are questions about our relationship with physicians. By being transparent, hopefully we can diminish some of those questions.”

Eli Lilly is caught up in its own allegations of marketing malfeasance over its drug Zyprexa, as it defends itself against a multi­million-dollar lawsuit by the Connecticut attorney general. The suit alleges “a complex series of illegal rackets and lies,” involving “payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies.”

“Eli Lilly’s endorsement goes to show that transparency of the financial ties between doctors and drug makers is not only sensible but doable,” said Sen. Herb Kohl (D-Wis.), chairman of the Special Committee on Aging and co-sponsor of the Bill . He said he hoped “the rest of the industry follows their lead.”

Eli Lilly is currrently mired in allegations of marketing malfeasance over its drug Zyprexa, as it defends itself against a multi­million-dollar lawsuit by the Connecticut attorney general. The suit alleges “a complex series of illegal rackets and lies,” involving “payments to public officials, bogus educational events and ghostwritten promotional articles summarizing suspect studies.”

Some observers say that Eli Lilly's support for Chuck's Bill may be the signal that the company (Now under new leadership with a chnaged managment structure) is moving away from traditional industry practices of promoting its products by developing close relationships with physicians.

The Tin Ear Tendency ...

Other companies — most prominently, Schering-Plough — are taking a more blinkered traditional stance against the legislation, arguing that "public disclosure of the payments would confuse patients and unfairly taint physicians who take industry money". They wrote a fascinating letter to Chuck which can be viewed here. .....“we do not publish or have plans at the moment to publish a list of charitable contributions or educational grants that medical organizations have received from us.”.. but they do list political contributions on their website ... hopefully that doesn't "confuse patients". see Shearlings get Plowed a website interested in the interesting affairs of SC

Ther should be a lesson here for Nu-Labour as UK General Practioners, spurred by extra salary entitlements engage in bogus "healthcare surveys" , which slide into drug industry programs.

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