CDC update on H1N1 situation

For additional information, click here to access the CDC's website.

No branded pharma gift too small?

Check out the Archives of Internal Medicine article "Effect of Exposure to Small Pharmaceutical Promotional Items on Treatment Preferences" to find the answer. Click here to access.

Vermont bill amended

From the Prescription Project Blog:

In the eleventh hour of its legislative session Friday night, Vermont passed a bill that would:

-ban most gifts to physicians,
-lift the trade secrets exemption in Vermont’s current gifts disclosure and transparency law,
-extend it to medical device manufacturers, create a public website to house the information, and
-broaden the type of payment recipients that companies would be required to disclose.

The bill now goes to the governor. Click here to access.

Dr. Frieden to head up the CDC

From the New York Times article:

President Obama announced on Friday that he has chosen Dr. Thomas R. Frieden, the New York City health commissioner, as the next director of the Centers for Disease Control and Prevention.
...
At the C.D.C., he will inherit a host of immediate and long-term problems, including a looming decision about whether and how to produce a swine flu vaccine. Health experts say the agency must resolve serious morale and organizational issues even as the administration struggles to overhaul the nation’s health care system.
...
Dr. Frieden has a history of focusing on health threats that endanger large numbers of people, sometimes at the expense of more popular causes.

Click here to access the NYT article.

The 2008 AAMC/SACME Harrison Survey

Click here to access.

A cereal prescription?

The FDA issued a warning letter to Ken Powell, Chairman of the Board and CEO of General Mills relative to the "the label and labeling" of Cheerios® Toasted Whole Grain Oat Cereal. From the letter:

FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).
...
Based on claims made on your product's label, we have determined that your Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease.

Click here to access the letter.

Staffing changes at ACCME

Click here to access ACCME's news release.

Mother of the year?

MedPage Today® named the Best Overall Web Publication by the ASHPE

From the MedPage Today® news release:

A first-time entrant, MedPage Today took the top spot and earned the Gold Award in the ASHPE competition's Online Category. A panel of well-respected business journalists and academics judged the entries against the publication's mission, the relevance to the category for which it was being considered, and its significance to the publication's target audience.

Click here to access.

Sen. Grassley to stay put (for now)

From the FiercePharma article:

Big Pharma won't escape from Sen. Charles Grassley's eagle eye yet. Rather than slipping into newly Democratic Sen. Arlen Specter's seat on the Senate Judiciary Committee, Grassley made a deal to postpone his move until the next Congress launches in 2011, the New York Times reports. In the meantime, the ranking Republic on Judiciary will be Sen. Jeff Sessions--and Grassley will stay firmly fixed on the Finance Committee, the better to influence healthcare reform and follow through on his pharma-oversight initiatives.

Click here to access.

Robert Wood Johnson posts "More Than Words Toolkit Series"

From the Robert Wood Johnson website:

Clear communication is a cornerstone of patient safety and quality health care. Quality translated health materials can serve as valuable communications tools for both patients and providers, and can help to ensure the delivery of safe, effective and high-quality care.

The More Than Words Toolkit Series, a resource developed by Hablamos Juntos with support from the Robert Wood Johnson Foundation, clarifies the translation process and provides a roadmap to help health care organizations improve the quality of their translated materials in order to get better results.

The More than Words Toolkit Series draws on the scientific literature, the experience of 10 Hablamos Juntos demonstrations and the initiative’s own research on translation quality. It is designed to assist individuals and organizations in initiating translations of health care text of all types.

For organizations that need to assess the quality of translated materials, users can find professionals who can rate materials based on the Translation Quality Assessment (TQA) tool.

Click here to access the toolkit.

Additional resources on swine flu

Click here for the WHO updates. Click here to access PandemicFlu.gov. Let's all take a few deep breaths (just not around anyone who is coughing and sneezing).

Confirmed swine flu cases and precautions by country

USA Today has posted an interactive map which they indicate will be updated as the outbreak progresses. Click here to access.

Grassley leaving Senate Finance Committee?

From the FiercePharma article:

Dancing in the streets yet? If you're not, then you haven't heard that Sen. Charles Grassley, the perpetual thorn in pharma's side, looks to be stepping down from his post as chief of the Senate Finance Committee. He's planning to move to Senate Judiciary instead, where the top Republican post was abandoned by Sen. Arlen Specter, a newly minted Democrat.

If the word on Grassley is true, then pharma may be able to say sayonara to the steady flow of letters from Grassley, who demanded answers on a plethora of industry issues, from drugmakers' relationships with prominent doctors and academic researchers to a host of drug safety questions.

Click here to access.

Dalhousie offers Online Education on Swine Flu (H1N1)

Click here to access.

CDC Interim Guidance for Clinicians & Public Health Professionals on Swine Flu (H1N1)

Click here to access.

Institute of Medicine releases COI report

From the Science News article:

1) Congress should require that pharmaceutical, device and biotechnology companies report on some public website all payments they make to physicians, researchers and medical organizations. "Such a public record would deter inappropriate relationships,” Lo said, and help medical institutions, publishers and others verify that physicians and researchers who do work for them have disclosed all real or potential conflicts of interest.

2) Medical centers and other research institutions should establish a policy prohibiting human trials if the researchers "have a significant financial interest in an existing or potential product or a company that could be affected by the outcome of the research." Any exceptions should be made public and allowed if only if no unbiased researchers can be found. And even then, the report said, a mechanism must exist to make data on the potential bias publicly available.

3) Research centers and hospitals should prohibit faculty, students, residents and medical fellows from: accepting “items of material value” from industry; giving presentations or writing papers where content is controlled by industry or “written by someone who is not identified as an author or who is not properly acknowledged;” consulting without a written contract and receiving payment at “fair market value" for services; using or distributing drug samples provided by industry “except in specified situations for patients who lack financial access to medications.”

4) Most state licensing boards, medical-specialty boards and hospitals require that physicians commit to lifelong learning. Indeed, participation in continuing medical education, or CME, courses can be essential for a doctor to remain licensed or certified. The new report finds that industry provides roughly 25 percent of the funding to run CME courses offered by professional societies, more than half of the costs to medical schools for CME courses and almost 75 percent of the costs incurred by outside commercial groups who offer CME courses. That’s got to change, the IOM panel argues. Indeed, Lo says, “the goal would be to have a [CME] system . . . that is free of industry or industry influence.”

Click here to access the Science News article. Click here to access the free Executive Summary of the IOM report.

AMA throws their hat into the online ring

From the FierceHealthIT news article:

The American Medical Association is pilot-testing what could turn out to be a hefty portfolio of web services to doctors, including electronic prescribing capabilities, reference databases and access to online continuing medical education. To build the services, the AMA is working with the Detroit-based healthcare IT platform provider Covisint.

Click here to access.

Resources on Swine Flu

Click here to access.

ACCME issues calls for comments...

• ACCME Rule Making


• Commercial Support-Free Accredited Continuing Medical Education designation


• Promotional Teacher and Author-Free Accredited Continuing Medical Education designation


• Independent CME Funding Entity
  
  Click here to access.

CMEHUB (online CME catalog)

Came across an online CME course catalog that allows physicians to search for CME courses by keywords, and CME providers apparently can have their CME courses listed for free. Click here to access. Disclosure: I have no relationship with this website service.

A champion bull rider/an elegant fox trotter

My hat is off to you, Ty!

A checklist for ethics?

From the AMNews article:

For ages, doctors have used lists and other reminders to help them give the right care to patients. Recently, the use of checklists in areas such as surgery and infection control has delivered remarkable results, greatly reducing morbidity and mortality.

Beginning in April, residents working in the intensive care unit at the Washington Hospital Center in Washington, D.C., got a different kind of reminder when caring for patients -- an ethics checklist.

The idea is the brainchild of Daniel K. Sokol, PhD, a medical ethicist at the University of London St. George's Hospital Medical School who served as a visiting bioethics scholar at the Washington Hospital Center in January and February.

Click here to access.

ACCME posts examples from providers

ACCME posted a compendium of actual provider practices that were reviewed through the accreditation process over the past several months. Click here to access this resource.

Harvard-affiliated hospitals issue new COI policy

From the NEWSInferno article:

Hospitals affiliated with Harvard University are implementing a stricter conflicts-of-interest policy for their doctors. According to a press release from Partners in Health Care, the new policy not only bans doctors from accepting gifts from drug or medical device makers, it also prevents physicians from serving as paid speakers for such companies.
...
In addition to banning gifts - including free meals - and paid speaking engagements, the new policy also bars drug makers from accepting fee drug samples. Instead, such samples must be provided through a hospital pharmacy or another central mechanism. Sales reps won’t be able to visit staff unless they have “written invitations defining the purpose and terms of visits”, the press release said.

Click here to access the article.

Google and Microsoft think HIPAA doesn't apply to them

From the iHealthBeat article:

Google and Microsoft maintain that they are not subject to HIPAA privacy regulations, BNET Healthcare reports.

Last month, Google Health Product Manager Roni Zeiger said, "Our understanding is that HITECH, which is the jargon for (the health IT) part of the legislation, did not change the definition for a covered entity or a business associate, so our service is offered directly to the consumer." He added, "(O)ur understanding is that we are neither a covered entity nor a business associate. We're providing a service directly to the consumer or a patient."

At this week's annual Healthcare Information and Management Systems Society conference in Chicago, David Cerino, general manager of Microsoft's Health Solutions Group, said, "We're still outside" of HIPAA.

Click here to access the article.

Something seniors should be aware of...

From the New York Times article:

EARLY this year, Barbara Plumb, a freelance editor and writer in New York who is on Medicare, received a disturbing letter. Her gynecologist informed her that she was opting out of Medicare. When Ms. Plumb asked her primary-care doctor to recommend another gynecologist who took Medicare, the doctor responded that she didn’t know any — and that if Ms. Plumb found one she liked, could she call and tell her the name?
...
Two trends are converging: there is a shortage of internists nationally — the American College of Physicians, the organization for internists, estimates that by 2025 there will be 35,000 to 45,000 fewer than the population needs — and internists are increasingly unwilling to accept new Medicare patients.

Click here to access the NYT article.

Check out this new JAMA article

"Professional Medical Associations and Their Relationships With Industry: A Proposal for Controlling Conflict of Interest". Click here to access (sub. req.)

End of the industry RFP?

From the Milwaukee Journal Sentinel article "Drug firms' cash skews doctor classes":

Do your legs feel tingly? Do you suffer from mood swings before your period? Would you take a mind-altering drug to quit smoking?

If so, the pharmaceutical industry and the University of Wisconsin-Madison want to teach your doctor a lesson.

Drug companies have largely taken over the field of doctor education, in part by bankrolling physician education courses at medical schools.

Critics say the practice increases medical costs by encouraging doctors to write prescriptions for expensive brand-name drugs and by exaggerating the frequency and prevalence of rare conditions. It also promotes the use of drugs not approved for the ailments.

A Journal Sentinel investigation found that industry-funded doctor education courses offered at UW often present a slanted view by favoring prescription medications over non-drug therapies and by failing to mention important side effects.

Click here to access the MJS article. Click here to read Dr. Carlat's blog posting on this article. Hey, I just tell you what's out there in the news!

Joint Accreditation for the Provider of Continuing Education for the Healthcare Team Now Available

Click here for the news release. Click here for information on eligibility, accreditation criteria, accreditation processes and outcomes.

ACCME releases new Q&A on the Standards for Commercial Support of CME

Click here to access. Oh, if only it were this simple....there might be another consideration regarding the provision of skills training. What do y'all think?

ABMS announces new standards on physician life-long learning

From the ABMS news release:

The ABMS Board of Directors (BOD) approved the standards, proposed by the ABMS Committee on Oversight and Monitoring of Maintenance of Certification (COMMOC), at its March 16 meeting. This uniform set of standards outlines and sets timelines for officially adopting several new MOC program elements, including:

* Documentation that physicians are meeting continued medical education (CME) and self-assessment requirements
* Evidence of participation in practice-based assessment and quality improvement every two to five years
* Completion of a patient safety self-assessment program at least once during each MOC cycle .
* Assessment of communication skills as a standard for all physician diplomates with direct patient care - using a Consumer Assessment of Healthcare Providers and Systems (CAHPS) patient survey (or other COMMOC-approved survey), and an approved peer survey

Click here to access the news release.

Vitamin D3

Check out the Archives of Internal Medicine article on Vitamin D3. The authors' conclusion?

Nonvertebral fracture prevention with vitamin D is dose dependent, and a higher dose should reduce fractures by at least 20% for individuals aged 65 years or older.

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

CDC statistics on non-fatal falls associated with dogs and cats

From the MMWR report:

Falls are the leading cause of nonfatal injuries in the United States. In 2006, nearly 8 million persons were treated in emergency departments (EDs) for fall injuries (1). Pets might present a fall hazard (2), but few data are available to support this supposition. To assess the incidence of fall-related injuries associated with cats and dogs, CDC analyzed data from the National Electronic Injury Surveillance System All Injury Program (NEISS-AIP) for the period 2001--2006. This report describes the results of that analysis, which showed that an estimated average of 86,629 fall injuries each year were associated with cats and dogs, for an average annual injury rate of 29.7 per 100,000 population. Nearly 88% of injuries were associated with dogs, and among persons injured, females were 2.1 times more likely to be injured than males. Prevention strategies should focus on 1) increasing public awareness of pets and pet items as fall hazards and of situations that can lead to fall injuries and 2) reinforcing American Veterinary Medical Association recommendations emphasizing obedience training for dogs (3).

Click here to access the MMWR report. Bob (above) swears he's not responsible for any of those falls!

AARP's take on the top 125 hospitals

From the AARP The Magazine: article

But just because a particular hospital appears to be the most successful at treating your disorder doesn't mean you should go there. Deciding whether to travel for care can involve weighing difficult trade-offs. Travel costs money, even if insurance covers the cost of treatment...And it's impossible to put a price tag on the advantages of being in familiar surroundings, cocooned by family and friends who can stay by your side and ask questions.

Click here to access the AARP article.

APA just says no to satellite industry events at annual meeting

From the New York Times article:

Amid increasing Congressional scrutiny of ties between doctors and drug makers, the American Psychiatric Association announced on Wednesday that it would end industry-financed medical seminars at its annual meeting. The association, the field’s premier organization, said it would also phase out meals at the meeting paid for with industry money.
...
Industry-supported seminars are commonplace at annual meetings throughout medicine, as are payments to doctors and other financial arrangements. The psychiatric association said it had no plans to eliminate drug advertisements in its journals, commercial exhibits at meetings, or industry-sponsored fellowships for doctors.

Click here to access the NYT article.

Tuberculosis worldwide

The website GlobalHealthFacts.org has just posted the 2007 stats on TB. Click here to access. Remember that book The Coming Plaque? Well, the author, Laurie Garrett also wrote this book: Betrayal of Trust: The Collapse of Global Public Health.

CACHE Open Access Library

The Open Access Library on the CACHE Web site (Canadian Association of Continuing Health Education) contains links to a large number of Open Access publications in continuing medical education. Courtesy of Anne Taylor-Vaisey MLS, Reference Librarian at the CMCC Health Sciences Library, click here for a link to the full text of all the articles in the special March 2009 CME supplement of Chest (as well as links to the PubMed records for these articles). Additionally, you might also want to click here and visit CACHE's Web Resources section (includes an External Power Search engine that searches within many of the sites that CACHE links to). A BIG thanks to Anne!

Make your voice heard!

Do you want to email the President and let him know your thoughts on anything? If so, click here. Google your senators and representatives and email them as well.

Dr. Hamburg to head FDA?

From the New York Times article:

President Obama intends to nominate Dr. Margaret A. Hamburg, a former New York City health commissioner, to lead the Food and Drug Administration, sidestepping a battle between drug safety advocates and the drug industry, people briefed on the decision said.
...
The F.D.A. is arguably the most important public health agency in the country, but its budget has lagged far behind those of agencies like the Centers for Disease Control and Prevention. A growing list of scandals has led a bipartisan chorus on Capitol Hill to demand major changes and larger budgets, with some legislators advocating that the F.D.A. be split in two.

Click here to access the NYT article. Click here to access Dr. Hamburg's bio.

Mass. passes regs on pharma and med device companies

From the Boston Globe article:

State officials gave final approval yesterday to regulations banning pharmaceutical and medical device companies from providing gifts to physicians, limiting when companies can pay for doctors' meals, and requiring companies to publicly disclose payments to doctors over $50 for certain types of consulting and speaking engagements.
...
There are two substantive changes, however. Companies will have to disclose payments to doctors and hospitals for research designed to promote a particular product, sometimes called "seeding trials"; funding for research aimed at answering a scientific question will still not have to be disclosed.

Also, the department eliminated a provision allowing companies to provide financial assistance for medical residents and other trainees to attend conferences and education courses.
...
The regulations will take effect July 1, and the first public reporting by companies will be due by July 1, 2010.

Click here to access.

Seton Hall Law School 's Center for Health & Pharmaceutical Law & Policy Releases White Paper Recommending Reform of Drug & Device Promotion

The recommendations regarding industry support of CME:

• A paradigm shift to end commercial support for CME should be undertaken. This will require fundamental change in practice by industry and by organized medicine, which must design less costly, professionally-driven and controlled mechanisms for CME.

• In the interim, as CME makes this substantial transition, conflicts of interest in CME should be more fully disclosed and managed. Specifically, disclosure to CME providers and attendees by physicians and other speakers should identify the nature and magnitude of the speaker’s financial interests, with such interests defined broadly to include financial relationships and support for the speaker’s academic department.

• The Accreditation Council for Continuing Medical Education (ACCME) should issue more specific guidelines that address financial disclosure, circumstances when safeguards such as independent review are required to manage a conflict of interest, and criteria to determine when conflicts should preclude participation by a presenter. A physician’s role promoting a product should preclude his or her participation as a speaker at an accredited CME event for that product.

Click here to access the white paper.

"Fraud Case Rocks Anesthesiology Community"

From the Anesthesiology News article:

In what experts are calling one of the largest known cases of academic misconduct, a leading anesthesiology researcher has been accused of falsifying data and other fraud in potentially dozens of published studies.

Click here to access the article.

Medical imaging quality gap?

From the New York Times article:

More than 95 million high-tech scans are done each year, and medical imaging, including CT, M.R.I. and PET scans, has ballooned into a $100-billion-a-year industry in the United States, with Medicare paying for $14 billion of that. But recent studies show that as many as 20 percent to 50 percent of the procedures should never have been done because their results did not help diagnose ailments or treat patients.

“The system is just totally, totally broken,” said Dr. Vijay Rao, the chairwoman of the radiology department at Thomas Jefferson University Hospital, in Philadelphia.
...
Accrediting will be partly addressed by a little noticed aspect of a wide-ranging Medicare law passed last year. After it goes into effect in 2012, Medicare will pay only for scans done at accredited centers. But imaging experts say the law fixes only part of the problem. High-tech scanning is complicated, and there is no consensus on objective measures to ensure quality. Even with the new law, there is still little assurance that scans will be appropriately ordered and interpreted or that a scanner will be up to date.

Click here to access.

Sebelius nominated for HHS secretary

From the New York Times article:

Gov. Kathleen Sebelius of Kansas was chosen as secretary of health and human services on Monday by President Obama, who hailed her as an ideal person to work with Republicans as well as Democrats to fix an ailing health care system.
...
But on matters of health policy, which she will oversee if her nomination is confirmed by the Senate, Ms. Sebelius’s efforts to forge bipartisan consensus have rarely succeeded. She recently observed that the greatest frustration of her six years in office had been her inability to persuade lawmakers to raise tobacco taxes for a modest expansion of government health coverage.

Now, with the backing of a Democratic Congress, Ms. Sebelius will have a chance to achieve in Washington what she failed to accomplish in Topeka, and then some. Mr. Obama is effectively making her the point person for what may become the largest expansion of taxpayer-subsidized health insurance in more than four decades.

Click here to access.

Forest accused of fraud

From the FierceBiotech article:

A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company's marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs.
...
The United States alleges that federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest.

Click here to access the article.

Responses to AMA Council on Ethical and Judicial Affairs and the Council on Medical Education on Conflict of Interest and Bias

For SACME's response, click here.
For NAAMECC's response, click here.
For CMSS's response, click here.
Thanks to SACME for posting all of these responses! It will be interesting to see the outcomes of the 2/25/09 CME Stakeholders Meeting in Chicago.

Vitamin D lessens the chance of catching a cold?

From the CNN.com article:

One reason vitamin D is so interesting is that unlike other vitamins, vitamin D acts as a hormone in the body and is known to help regulate at least a thousand genes, said Melamed. It's a cell-signaling molecule that may play a role in controlling the immune system, fighting cancer, improving cardiovascular health, and possibly regulating blood sugar. (There are vitamin D receptors in blood vessels and in the pancreas, which regulates blood sugar.)

For now, the jury is still out on vitamin D's link to respiratory infections. But it's a tantalizing link.

Click here to access the article.

IOM releases report on uninsured in U.S.

From the National Academies press release:

The evidence shows more clearly than ever that having health insurance is essential for people's health and well-being, and safety-net services are not enough to prevent avoidable illness, worse health outcomes, and premature death, says a new report from the Institute of Medicine. Moreover, new research suggests that when local rates of uninsurance are relatively high, even people with insurance are more likely to have difficulty obtaining needed care and to be less satisfied with the care they receive.
...
The report responds to key questions being raised in the national debate about health care reform, including whether having insurance is essential for gaining access to necessary services given the availability of charity and free emergency care, and whether lack of coverage has wider ripple effects on whole communities. Written by a committee of experts in medical care, emergency medicine, health policy, business, economics, and health research, the report provides an independent assessment of published studies and surveys as well as newly commissioned research on the impacts of lack of coverage.

Click here to access the press release.

Pneumonia vaccine may cut risk of MIs

From the Canada.com article:

A vaccine that helps protect against pneumonia can also cut the risk of heart attacks, opening the door to a safe and inexpensive way to prevent thousands of cardiac deaths each year, new research shows.

The vaccine, typically used to protect the elderly against the most common cause of bacterial pneumonia, can lower the rate of heart attacks by as much as 50 per cent, says the study, published in the latest issue of the Canadian Medical Association Journal.

Click here to access the lay article. Click here to access the CMAJ abstract (sub. req.).

Army Medical goes to voice recognition technology

From the Healthcare IT News article:

The U.S. Army Medical Department has expanded its use of speech technology to 10,000 of its physicians to more than 90,000 worldwide.
...
"The use of voice-recognition software with the AHLTA e-health record system is freeing doctors from several hours of typing into AHLTA their various patient notes each week," said Robert Bell Walker, European Regional Medical Command AHLTA consultant and a family practice physician for the military.

Click here to access.

"Comparative effectiveness research"

From the New York Times article:

The $787 billion economic stimulus bill approved by Congress will, for the first time, provide substantial amounts of money for the federal government to compare the effectiveness of different treatments for the same illness.

Click here to access.

Medical Meetings Magazine's Annual Physicians' CME Preferences Survey

Click here to access the MM article on the survey results.

Pfizer Transparency

From Pfizer's press release:

Pfizer Inc today announced its plans to make publicly available its compensation of U.S. healthcare professionals for consulting, speaking engagements and clinical trials. The disclosure will include payments made to practicing U.S. physicians and other healthcare providers, as well as principal investigators, major academic institutions and research sites for clinical research. This makes Pfizer the first biopharmaceutical company to commit to reporting payments for conducting Phase I-IV clinical trials in addition to disclosing payments for speaking and consulting. This disclosure demonstrates Pfizer’s commitment to increased transparency and public candor.

Click here to access.

Additional ACCME info on that breakout session at the Alliance

Click here to access.

Patient education?

From the Healthcare Finance News article:

Thirty days after their hospital discharge, the 370 patients who participated in the RED program had 30 percent fewer subsequent emergency visits and readmissions than the 368 patients who did not. Nearly all (94 percent) of the patients who participated in the RED program left the hospital with a follow-up appointment with their primary care physician, compared to 35 percent for patients who did not participate.

And 91 percent of participants had their discharge information sent to their primary care physician within 24 hours of leaving the hospital.

Click here to access the HFN article. Click here to access the Annals of Internal Medicine article (sub. req.).

"Closing the Quality Gaps Using the ACCME Updated Accreditation Criteria"

This session was presented at the recent Alliance conference by Steve Singer, PhD, Director, and Marcia K. Martin, Manager, respectively, of the ACCME's Education , Monitoring,and Improvement Division. Click here to access their materials posted online at the ACCME web site.

More docs in Congress

From the Chicago Tribune article:

"The number of physicians in Congress continues to grow, with 16 physicians in the 111th Congress, demonstrating intense physician interest in making a difference in people's health and their lives," said Dr. Nancy Nielsen, president of the AMA.

Click here to access the article.

New AMA web site

From the Medical News Today article:

Offering a fresh look and redesigned content, the American Medical Association (AMA) today launches a new Web site to help physicians, residents, and medical students easily obtain resources and tools relevant to their individual professional needs.
...
Physicians can find useful billing and reimbursement resources, along with numerous tools ranging from patient education to clinical practice standards.

Click here to access the article; click here to access the new AMA web site.

Harvard medical school to toughen COI policy

From the Boston Globe article:

Harvard Medical School plans to strengthen its conflict-of-interest rules for doctors and researchers, amid a US Senate investigation into several faculty members and a new state law that will make public some of the payments doctors receive from pharmaceutical and medical-device companies.

Many top medical schools, including Stanford University, the University of Pennsylvania, the University of California at Los Angeles and at San Francisco, and the University of Massachusetts have adopted stricter policies in the past two years. Last year, the American Medical Student Association graded Harvard with an F on its conflict-of-interest policy because it does not address issues like whether companies can provide gifts and meals for faculty.

Click here to access the article.

FDA to research DTC advertising

From the AMNews article:

The Food and Drug Administration has outlined a novel study designed to measure participants' recall and comprehension of risk and benefit information in television ads.

The agency will produce ads for a fictitious blood pressure medication and recruit 2,400 participants to view them and report on the messages they take away. The study design was announced in the Dec. 30, 2008, Federal Register, and the agency is gathering comments until Jan. 29. The FDA's intention to conduct the study was first announced in 2007.

Click here to access the article.

Fantastic Voyage?

From the New York Times article:

THE doctor’s advice to “take two aspirin and call me in the morning” may one day be updated to “take this pill, and it will call me in the morning.”

Philips Research in Eindhoven, the Netherlands, has developed a prototype for a pill that can be programmed to navigate toward a specific trouble spot in the body and deposit its medicine there, radioing dispatches to the doctor as it travels.

Click here to access the NYT article.

Doctor Who?

From the New York Times article:

Researchers at the University of Chicago interviewed 2,807 adults admitted to the school’s hospital over a 15-month period. The patients were asked about the roles of the various physicians attending to them and to name the doctors on those teams. Medical teams consisted of three to four people, including medical students, residents and attending physicians.

Some 75 percent of the patients were unable to name a single doctor assigned to their care. Of the 25 percent who responded with a name, only 40 percent were correct. Those patients who claimed to understand the roles of their doctors were more likely to correctly identify at least one of their physicians.

Click here to access the article.

Delays in getting women with heart trouble to ERs

From the New York Times article:

But 647 patients, about 11 percent, were delayed, spending 45 minutes or longer in the care of emergency workers.

Women were 52 percent more likely than men to be among the delayed, said Thomas W. Concannon, an assistant professor of medicine at Tufts University who was lead author of the study, published this month in Circulation: Cardiovascular Quality and Outcomes.

It is not clear what caused the waits, he said, but other studies have suggested that heart problems in women are not recognized as readily by medical personnel.

Click here to access the NYT article. Click here to access the Circulation: Cardiovascular Quality and Outcomes journal article.

Mayo CME Consensus Conference Proceedings now available

The proceedings of the September 24-26, 2008 invitational Mayo CME Consensus Conference held at the Mayo Clinic in Rochester, MN, and co-sponsored by the Society for Academic Continuing Medical Education (SACME), the Accreditation Council for Continuing Medical Education (ACCME), and the Mayo Clinic has been posted online. Click here to access.

ACCME's New Approach to Transparency

Click here to read Dr. Kopelow's memo. I'd like to see ACCME require CME providers placed on probation to have to utilize a different accreditation statement, one that denotes that status.

Fair Market Value?

Check out the article on fair market value over at Pharmaceutical Executive, an excerpt:

The best approach is to rely on the knowledge base of fair market value that exists in other settings. Fair market value is a term of art. It's generally defined as a value negotiated at arm's length between a hypothetical willing buyer and a hypothetical willing seller. The IRS has very clear guidelines on methodologies that are acceptable from the standpoint of a fair market value standard. Those standards and the fair market value body of knowledge can generally be cross-walked to the determination of the fair market value of a compensation arrangement. For example, with traditional business valuations the primary approaches are cost, income, and market. Likewise, in a compensation valuation setting, consideration can be given to the same three valuation approaches—so we're using the guidelines and the techniques that were developed in business valuations and applying them to compensation valuation.

As CME providers conduct their annual review of their faculty honorarium policy, they might want to include this article as part of that review process. Click here to access the article.

$20 Billion allocated for Health IT

is included as part of the $825 economic stimulus proposal released by the House Appropriations Committee. From the iHealthBeat article:

Of the $20 billion, $2 billion would go to HHS' Office of the National Coordinator for Health IT (Ferris, Government Health IT, 1/15).

ONCHIT could use the funding to:

* Invest in IT architecture supporting health information exchanges and the national health information network;
* Provide grants to help health care providers adopt health IT products; and
* Train health care providers and IT professionals (Health Data Management, 1/15).

Some experts said that there are reports that at least some of the remaining $18 billion would be used to provide health IT grants to states (Government Health IT, 1/15).

Click here to access the article.

Updated AdvaMed Code

AdvaMed or the Advanced Medical Technology Association has updated their code of ethics and it takes effect July 1, 2009. Click here to access the updated code. Click here to access a comparison chart (compares old and updated code with the PhRMA code). A tad interesting, methinks, where they place "grand rounds" in their code.

FDA Guidance on "Good Reprint Practices" for Industry

Yep! The FDA has issued recommendations, but keep in mind this excerpt from the introduction:

FDA's guidance documents do not establish legally enforceable rights or responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

Also from the document:

FDA does recognize, however, the important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications on unapproved uses of approved drugs and approved or cleared medical devices to healthcare professionals and healthcare entities. Once a drug or medical device has been approved or cleared by FDA, generally, healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product's approved labeling (or, in the case of a medical device cleared under the 510(k) process, in the product's statement of intended uses). These off-label uses or treatment regimens may be important and may even constitute a medically recognized standard of care. Accordingly, the public health may be advanced by healthcare professionals' receipt of medical journal articles and medical or scientific reference publications on unapproved new uses of approved or cleared medical products that are truthful and not misleading.

It will be interesting to see what happens with the new administration. Click here to access the guidance document.

New clinician-consumer health info website

From the istockanalysis.com article:

A new educational Web site offers expert perspectives, advice and guidance on drugs, biological products and medical devices from the Agency for Healthcare Research and Quality's Centers for Education and Research on Therapeutics (CERTs), a federally sponsored network of more than a dozen leading research centers nationwide. The Clinician-Consumer Health Advisory Information Network (CHAIN) http://www.chainonline.org links clinicians and consumers with therapeutics information to assist in clinical practice and health care decision-making in areas where evidence is undergoing significant and rapid changes.

Click here to access the website.

ACCME makes headlines

From the New York Times article "Medical Journal Changes Its Policy After Criticism by Group":

But the Accreditation Council for Continuing Medical Education, in a letter to a cancer research newsletter, said the journal and its publisher, the Massachusetts Medical Society, had erred in failing to disclose “relevant financial conflicts of interests of the authors.”

The study failed to disclose that Dr. Henschke’s work had been underwritten in part by a $3.6 million grant from the parent company of the Liggett Group, a cigarette maker, something the journal editors said they had been unaware of.

Click here to read. What about content validation?

New California health care-related laws in effect Jan 1, 2009

From the CaliforniaHealthline article (the bolding is mine):

Hospital Infection Control

* SB 1058, also by Alquist, requires hospitals to screen certain high-risk patients for Methicillin-resistant Staphylococcus aureus and report their infection rates to the state. Beginning in 2011, the information will be accessible to the public on a state Web site.
* SB 158 by Sen. Dean Florez (D-Shafter) gives the state additional authority to look into infection outbreaks and complaints about lax infection control practices. The law also requires hospitals to provide education and training opportunities for workers (Rojas, Sacramento Bee, 12/27/08).

End-of-Life Care

* Doctors who treat terminally ill patients will be required to inform them on all end-of-life options, including hospice care and the right to refuse treatment.

Click here to access this article and read about even more health care-related laws.

Doctor appointments on the web

An online service that offers doctor appointments via a webcam will go live in Hawaii on Jan 15. From the New York Times article on this new service:

Patients use the service by logging on to participating health plans’ Web sites. Doctors hold 10-minute appointments, which can be extended for a fee, and can file prescriptions and view patients’ medical histories through the system. American Well is working with HealthVault, Microsoft’s electronic medical records service, and ActiveHealth Management, a subsidiary of Aetna, which scans patients’ medical history for gaps in their previous care and alerts doctors during their American Well appointment.

Click here to access. Disclosure: I have no financial relationship with this new service.

Editorial in the New York Times on the new pharma rules

Check out the New York Times editorial: "No Mugs, but What About Those Fees?" An excerpt:

The updated rules are the industry’s latest attempt to restore public confidence that doctors are prescribing medicines in the patient’s interest. The code still has too many loopholes.

Click here to access. What do y'all think?

Overprescription of fluoroquinolones?

From the Atlanta Journal Constitution article:

In 2007, U.S. patients received more than 40 million prescriptions for fluoroquinolone antibiotics, according to IMS Health, a health care information company. Some studies have found these drugs are often misprescribed, chosen first by doctors when other antibiotics are more appropriate — or when none are needed.

Click here to access the AJC article.

ACCME releases examples of real-world compliance with the updated criteria

Click here to access.

True blue?

From the Washington Post article:

The Afghan chieftain looked older than his 60-odd years, and his bearded face bore the creases of a man burdened with duties as tribal patriarch and husband to four younger women. His visitor, a CIA officer, saw an opportunity, and reached into his bag for a small gift.

Four blue pills. Viagra.

"Take one of these. You'll love it," the officer said. Compliments of Uncle Sam.

Click here to access.

Doctor Nemeroff steps down

From Emory's news release:

Emory University has conducted an investigation into allegations of conflicts of interest involving Dr. Charles Nemeroff, the long-time chair of the Department of Psychiatry and Behavioral Sciences at the Emory University School of Medicine. Based on the results of that investigation, Dr. Nemeroff has agreed to step down from the departmental leadership post he held for 17 years and to follow new restrictions on his outside activities.

Additionally, Emory will not submit any NIH or other sponsored grant or contract requests in which he is listed as an investigator or has any other role for a period of at least two years. He will remain in the Department as a professor and will focus on clinical care, teaching and other academic pursuits.

Click here to access.

Medical Board of California changes CME requirements

From the California Physician article:

New CME reporting requirements recently passed by the medical board take effect in 2009. Physicians will now be required to complete 50 CME hours during every two-year licensure period. Previously, physicians were required to complete 100 hours every four years. CME will also be calculated based on the physician’s personal license renewal date (the last day of the month of your birthday), not the calendar year.

Click here to access.

Wishing Everyone Happy Holidays!

Gratitude is not only the greatest of virtues, but the parent of all others.
- Cicero (106 BC - 43 BC), 'Pro Plancio,' 54 B.C.

Medical publisher and Wyeth under scrutiny

From the New York Times article:

Mr. Grassley, a member of the Senate Finance Committee who is investigating drug company influence on doctors, contends that Wyeth commissioned the articles and had them ghostwritten by a medical writing firm. Only after the articles were conceived and under way did the firm line up doctors to put their names on them, Mr. Grassley contends.

“The charges made by Senator Grassley’s office with regard to the article published in 2003 by Dr. Eden are a significant concern to The Journal and Elsevier,” Glen P. Campbell, the senior vice president for Elsevier’s US Health Sciences Journals unit, said in a statement. “As with any charge of misconduct or inappropriate publishing acts, The Journal has launched its own investigation into the claims of ghostwriting and undisclosed financial support.”

The journal article, published more than a year after a landmark federal study linked Wyeth’s Prempro hormone product to breast cancer in women, said there was “no definitive evidence” the hormones caused breast cancer.

Click here to access the NYT article.

Barbara Barnes, MD, and Claudette Dalton, MD Named Chair and Vice Chair of the Accreditation Council for Continuing Medical Education

Click here to access this ACCME news release.

Wilford Brimley receives American Diabetes Association award

From the tcpalm.com article:

“I didn’t know about this,” he said after accepting the award. “I’m truly honored. I don’t know what to say here about this. I do know that I am responsible to share my experience, whatever strength I may have and my hope with anybody who cares to jump in the water.”

Click here to read the article.

"'CME-like'"

Apparently a new term coined by Emory? Check out Senator Grassley's most recent letter to the NIH regarding Dr. Nemeroff's conflict of interest "issues"; click here to access.

ADA/ACCF/AHA issue position statement

"Intensive Glycemic Control and the Prevention of Cardiovascular Events: Implications of the ACCORD, ADVANCE, and VA Diabetes Trials"; click here to access.

Breast Cancer and HRT

From the The Washington Post article:

Taking menopause hormones for five years doubles the risk for breast cancer, according to a new analysis of a big federal study that reveals the most dramatic evidence yet of the dangers of these still-popular pills.

Even women who took estrogen and progestin pills for as little as a couple of years had a greater chance of getting cancer. And when they stopped taking them, their odds quickly improved, returning to a normal risk level roughly two years after quitting.

Collectively, these new findings are likely to end any doubt that the risks outweigh the benefits for most women.

Click here to access the WP article.

PhRMA issues guiding principles on DTC advertising

Click here to access.

Electronic prescribing

The authors of a study just published in the Archives of Internal Medicine report that electronic prescribing and formulary decision support could result in substantial cost savings ($845,000 per 100,000 patients). Click here to access the abstract.

Drug combo for hypertension superior?

From the New York Times article:

The trial compared two pills, each containing two drugs used to lower blood pressure. Patients taking pills that combined an ACE inhibitor with a calcium-channel blocker suffered 20 percent fewer heart attacks, strokes, heart procedures and deaths than those taking an ACE inhibitor with a diuretic, the investigators found.

The study was funded by Novartis, which makes both of the two-in-one pill treatments evaluated, and published in Thursday’s issue of The New England Journal of Medicine.
...
Dr. Aram Chobanian, a professor of medicine and pharmacology at Boston University School of Medicine and author of the editorial, said he had questions about whether the diuretic was used appropriately in this trial, adding that a single trial is “not enough to recommend that everyone be on a calcium-channel blocker and an ACE inhibitor.”

Click here to access the NYT article.

Penn School of Medicine to disclose doc industry ties online

From the Philadelphia Inquirer article:

Some local patients may soon be able to learn whether their doctors are paid on the side by pharmaceutical firms or medical-implant makers.

In the spring, the University of Pennsylvania School of Medicine and its health system, known collectively as Penn Medicine, plan to launch a Web site that will contain searchable information on all outside activities of its doctors and scientists.

"When all of us are up there transparently, it may make us a little more responsible," said Arthur H. Rubenstein, dean of the medical school and head of Penn Medicine. "It is just human nature: If you know someone else is going to know what you are doing, you may be more careful."

Click here to access.

Cleveland Clinic's new online disclosure plan

From the New York Times article:

The Cleveland Clinic plans to announce this week it has begun publicly reporting the business relationships that any of its 1,800 staff doctors and scientists have with drug and device makers.

The clinic, one of the nation’s most prominent medical research centers, is making a complete disclosure of doctors’ and researchers’ financial ties available on its Web site, www.clevelandclinic.org.
...
“They are breaking a new path here,” said Dr. David J. Rothman, the president of the Institute on Medicine as a Profession, a nonprofit group based at Columbia University that studies potential conflicts of interest.

Click here to access the NYT article.

IOM report on resident fatigue

From the Washington Post article:

Medical and surgical residents in hospitals should work no more than 16 hours without taking a mandatory five-hour sleep break, and they should get one full day off a week and at least two back-to-back days off a month, a panel of experts at the Institute of Medicine recommended yesterday.

Click here to access.

Brand-name versus generic, is perception reality?

Check out the recent JAMA article "Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease." The results and the authors' conclusions:

Results: We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of {alpha}-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was –0.03 (95% confidence interval, –0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution.

Conclusions: Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.

Click here to access (sub. req.).

Disruptive Docs

From the New York Times article:

A survey of health care workers at 102 nonprofit hospitals from 2004 to 2007 found that 67 percent of respondents said they thought there was a link between disruptive behavior and medical mistakes, and 18 percent said they knew of a mistake that occurred because of an obnoxious doctor. (The author was Dr. Alan Rosenstein, medical director for the West Coast region of VHA Inc., an alliance of nonprofit hospitals.)

Another survey by the Institute for Safe Medication Practices, a nonprofit organization, found that 40 percent of hospital staff members reported having been so intimidated by a doctor that they did not share their concerns about orders for medication that appeared to be incorrect. As a result, 7 percent said they contributed to a medication error.

There are signs, however, that such abusive behavior is less likely to be tolerated. Physicians and nurses say they have seen less of it in the past 5 or 10 years, though it is still a major problem, and the Joint Commission is requiring hospitals to have a written code of conduct and a process for enforcing it.

Click here to access.

Allhat isn't "all that"?

Check out the New York Times article "The Minimal Impact of a Big Hypertension Study"; an excerpt:

The findings, from one of the biggest clinical trials ever organized by the federal government, promised to save the nation billions of dollars in treating the tens of millions of Americans with hypertension — even if the conclusions did seem to threaten pharmaceutical giants like Pfizer that were making big money on blockbuster hypertension drugs.

Six years later, though, the use of the inexpensive pills, called diuretics, is far smaller than some of the trial’s organizers had hoped.

Click here to access the NYT article.

Health beliefs

From the Reuters article:

Older African Americans more likely to rate their health as poor compared with older white Americans, even though when the two groups "are functioning extremely well, new research suggests.
...
The most likely explanation for the racial disparities seen in the current study, Spencer said, is that older African Americans have a different way of thinking about their health than do older whites. It's also possible, she added, that the accumulated affects of racism could be driving down their perception of their own health.

Click here to access.

We need hits!

Check it out:

Disclosure: I do not own any stock in this company.

Wartime lessons impacting trauma care

From the San Diego Union article:

Some of the war-zone techniques are forcing trauma specialists to rethink practices that have been standard for years.

“We are learning at warp speed,” said Dr. Michael Sise, a clinical professor of surgery and chief of the trauma unit at Scripps Mercy Hospital in Hillcrest. “This is the fastest transfer of wartime learning in history.”
...
The rapid assimilation of battlefield lessons largely is being driven by health providers who also are military reservists. Upon returning from deployments in Iraq or Afghanistan, they apply newly learned techniques to their civilian jobs, Sise said. The information spreads quickly among hospitals through the nation's highly networked trauma-care system.

Click here to access.

Kickback or incentive?

From the Associated Press article:

All the doctors had to do was show up, enjoy a free dinner at an elegant Rochester, N.Y., area restaurant specializing in steaks, chops and top-shelf wines, and pocket $100 on the way out the door.

Health insurance companies had invited the physicians to hear a pitch about the benefits of prescribing generic drugs instead of their pricier, name-brand competitors.

Click here to access.