To stent or not to stent or if I could turn back time...

From the New York Times article "Doctor Faces Suits Over Cardiac Stents":

The Senate Finance Committee, which oversees Medicare, started investigating Dr. Midei in February after a series of articles in The Baltimore Sun said that Dr. Midei at St. Joseph Medical Center, in Towson, Md., had inserted stents in patients who did not need them, reaping high reimbursements from Medicare and private insurance.

The senators solicited 10,000 documents from Abbott and St. Joseph. Their report, provided in advance to The New York Times, concludes that Dr. Midei “may have implanted 585 stents which were medically unnecessary” from 2007 to 2009. Medicare paid $3.8 million of the $6.6 million charged for those procedures.

Click here to access the NYT article.

Blogs and nepotism

Yep, definitely nepotism, but I wanted to let "my world" know about the new blog started by my nephew Erik's wife, Meadow.  Both Erik and Meadow are art teachers at Watts Atelier in the beach community of Encinitas, California -- both also freelance.  Meadow actually makes the period costumes for her paintings...her first blog posting is about how she is making a regency bonnet for a client...click here to check it out!.  Click here to see some of her paintings.  And, if you're missing Halloween, check out Erik's blog and his website (not for the faint of heart!).  Yes, I suppose my posting these links on my blog will be considered a "conflict of interest"...no resolution needed, however.

Health care fraud?

From the New York Times article "Side Effects May Include Lawsuits":

FOR decades, antipsychotic drugs were a niche product. Today, they’re the top-selling class of pharmaceuticals in America, generating annual revenue of about $14.6 billion and surpassing sales of even blockbusters like heart-protective statins.
...
Anointed with names like Abilify and Geodon, the drugs were given to a broad swath of patients, from preschoolers to octogenarians. Today, more than a half-million youths take antipsychotic drugs, and fully one-quarter of nursing-home residents have used them. Yet recent government warnings say the drugs may be fatal to some older patients and have unknown effects on children.
...
Such marketing, according to analysts and court documents, included payments, gifts, meals and trips for doctors, biased studies, ghostwritten medical journal articles, promotional conference appearances, and payments for postgraduate medical education that encourages a pro-drug outlook among doctors. All of these are tools that federal investigators say companies have used to exaggerate benefits, play down risks and promote off-label uses, meaning those the F.D.A. hasn’t approved.
...
Over the next year, the government is adding at least 15 prosecutors and 100 investigators to pursue health care fraud.

Click here to access the NYT article.

MA gift ban law intact?

Click here to read the Wall Street Journal's Health Blog's posting on this bill.

ICMJE posts updated disclosure form

Click here to access.

AAMC report "In the Interest of Patients...."

From the AAMC press release:

A new report by the AAMC (Association of American Medical Colleges) urges U.S. teaching hospitals to establish policies that manage financial relationships between physicians and industry so that they do not influence patient care. "In the Interest of Patients: Recommendations for Physician Financial Relationships and Clinical Decision Making" provides guidance on how academic medical centers can identify, evaluate, and disclose conflicts of interest in clinical care. 

ACCME provides add'l guidance on appropriate role of industry folks in CME

Click here to access the news release (a link to the additional guidance is provided within the news release).

PharmedOut Conference Happening Today!

PharmedOut is at this very moment conducting their conference "Prescription for Conflict: Should Industry Fund Continuing Medical Education?".  Click here to access the conference agenda.  Click here to read Policy and Medicine's blog posting on this conference.

University of Michigan just says no to commercial support of CME

From the New York Times article:

Dr. James O. Woolliscroft, dean of Michigan’s medical school, said leading faculty members “wanted education to be free from bias, to be based on the best evidence and a balanced view of the topic under discussion.”
 ...
The debate over whether the medical profession should develop an industry-free model of postgraduate education is a delicate one. A conference at Georgetown University on Friday, called “Prescription for Conflict,” will highlight the arguments on both sides through presentations by federal health officials, professors from leading medical schools, hospital executives and a Senate investigator.  

Click here to access the NYT article.

CMSS Voluntary Code of Ethics for Interaction with Industry

From the CMSS's press release:

The Council of Medical Specialty Societies (CMSS) today announced the release of the CMSS Code for Interactions with Companies. The code provides detailed guidance to medical specialty societies on appropriate interactions with for-profit companies in the health care sector. The voluntary code is designed to ensure that societies’ interactions with companies are independent and transparent, and advance medical care for the benefit of patients and populations. CMSS represents 32 leading medical professional societies, with a collective membership of more than 650,000 U.S. physicians.

Click here to access the press release. Click here to access the code.

Pfizer posts payments online

From the New York Times article:

Pfizer, the world’s largest drug maker, said Wednesday that it paid about $20 million to 4,500 doctors and other medical professionals for consulting and speaking on its behalf in the last six months of 2009, its first public accounting of payments to the people who decide which drugs to recommend.

Pfizer also paid $15.3 million to 250 academic medical centers and other research groups for clinical trials in the same period.

While other pharmaceutical companies have disclosed payments to doctors, Pfizer is the first to disclose payments for the clinical trials.

Click here to access the NYT article. Click here to access Pfizer's disclosure website.

Physician Sunshine Act now law

The Pew Prescription Project has just posted a fact sheet this new law—an excerpt:

The Physician Payments Sunshine provisions in health care reform legislation require drug and medical device manufacturers to publicly report gifts and payments made to physicians and teaching hospitals.

The Physician Payment Sunshine provisions were included in the Patient Protection and Affordable Care Act of 2009 (H.R. 3590, section 6002) which was signed into law on March 23, 2010.

Are gifts and payments limited?
The law requires public disclosure, but does not limit financial relationships.

Who must report? How often?
All U.S. manufacturers (and other entities under common ownership) of drug, device, biologics, and medical supplies covered under Medicare, Medicaid, or SCHIP must report payments on an annual basis to the department of Health and Human Services, which will post the information on a public website. The Secretary of Health and Human Services is further required to submit annual summary reports to Congress, as well as annual reports to each state.

What sort of payments count?
The health care reform law requires disclosure of payments whether cash or in-kind transfers to all covered recipients including: compensation; food, entertainment or gifts; travel; consulting fees; honoraria; research funding or grants; education or conference funding; stocks or stock options; ownership or investment interest; royalties or licenses; charitable contributions; and any other transfer of value as described by the secretary.

Click here to access the PPP fact sheet.

Stanford extends policy to adjunct faculty

From the New York Times article:

The Stanford University School of Medicine plans on Monday to introduce rules that would prohibit its volunteer teaching staff — called adjunct faculty — from giving paid speeches drafted by the makers of drugs or medical devices.

Stanford already has one of the most comprehensive policies in the country governing the interactions between academic faculty and the medical industry. The policy, enacted in 2006, is intended to limit potential industry influence on day-to-day clinical practice and medical education, according to a Stanford press release.

The policy prohibits faculty members from participating in industry speakers’ bureaus in which drug and medical device makers pay a physician to give company-prepared speeches to doctors about company medical products. It also prohibits Stanford faculty members from accepting free gifts, including drug samples for patients.

And as of Monday, the 660 community physicians who volunteer their time to teach at Stanford will also have to abide by the same policy — or give up their Stanford titles.

Click here to access the NYT article. Hap tip to Pharmalot.

WebMD gets letter from Senator Grassley

From the Senator's letter to the president of WebMD:

Recently, it was brought to my attention that WebMD Health Corporation (WebMD) is running a depression screening advertisement on television. This advertisement encourages the viewer to take a screening test sponsored by Eli Lilly on WebMDs website. I am concerned about the independence between WebMD and industry since many people access WebMD seeing it as an independent, objective medical resource.

Click here to access the letter which is posted online. Hat tip to Pharmalot.

"Uniform Format for Disclosure of Competing Interests in ICMJE Journals"

Click here to see the new form; click here to see an example completed form (gosh, there ARE other people out there with my sense of humor). Click here to access the JAMA editorial on this new form.

Canadian Medical Association criticized for accepting pharma funding

From the Globe and Mail article

The Canadian Medical Association is facing criticism over its decision to team up with a major pharmaceutical company to create an education program for physicians across the country.

Some members of the medical community say the CMA is heading down a dangerous road and warn that partnering with Pfizer Canada Inc. may cross a serious ethical line that could negatively influence doctors' treatment decisions.
...
Under the new CMA initiative, Pfizer Canada said it will provide $780,000 to fund the new “continuing medical education” or CME program, designed to inform physicians of new developments in medicine and help maintain their skills. Two Pfizer staff members will also sit on an administrative board, responsible for overseeing, implementing and evaluating the program, along with two staff members from the medical association and two individuals from outside organizations.

The program will be offered online and will focus on 12 different subjects. The first, expected to be made available early next year, will focus on Parkinson's disease. Other topics will be determined based on gaps identified by physicians in surveys posted on the CMA website.

Click here to access this article. Hat tip to Capsules!

New Jersey AG tries to clamp down on pharma

The AG's recommendations, as reported in the WSJ's Health Blog, are that physcians must:

• No longer accept food from industry, whether in office or in restaurants (this includes their office staff).
• Disclose, at the time of relicensure, whether they accepted more than $200 worth of payments and/or gifts from industry during the preceding two years.

Another AG recommendation is to curtail prescription data mining (this would require the state legislature to pass a new law).

The end of MECCs?

From the Wall Street Journal article:

Health legislation moving through Congress would force drug makers to disclose how much they spend on continuing medical education classes for doctors, sparking some resistance from the industry.

For-profit continuing medical education companies have seen revenue fall by double digits in the last year, according to industry statistics, following congressional investigations into the influence of drug makers on medical research and course content.

Click here to access the WSJ article (sub. req.).

ICMJE proposes new disclosure policy for authors

From the American Medical News article:

An influential group of medical journal editors in October announced a new, more probing conflict-of-interest disclosure form that it hopes will become the industry standard. The effort comes in response to criticism that medical journals have failed to properly inform their readers about authors' financial relationships with industry.

The uniform disclosure form, adopted by the International Committee of Medical Journal Editors, asks authors submitting for publication to disclose any payment for the research that generated the article as well as other kinds of industry relationships such as consultancies, honoraria or stock options from the last three years.

The form also asks authors to disclose whether spouses or children have financial relationships with "entities that have an interest in the content of the submitted work." Writers also should provide "any relevant nonfinancial associations or interests" of a personal, political or religious nature "that a reasonable reader would want to know about."

Click here to access the AMN article. Hat tip to FierceHealthcare.

Sunshine in the health care reform bill?

From the New York Times article:

As part of the health care overhaul under consideration by Congress, lawmakers have included so-called sunshine provisions intended to shed light on the financial relationships between the medical industry and doctors.

The targets are common business practices like drug company payments to doctors for speeches and consulting services, which have the potential to influence patient care and drive up the nation’s medical bills.

But if previous attempts by state legislatures, federal agencies and academic hospitals are any indication, such sunshine efforts are all too vulnerable to cloud cover.

Click here to access the NYT article.