Changes at the FDA...

The Food and Drug Administration announced some changes to monitor the safety of drugs. One strategy is to make an assessment of a drug once it's been on the market for 18 months. A second strategy is to form "an advisory panel to improve the way it announces safety worries." Apparently, this isn't good enough for Senator Christopher J. Dodd (Democrat, CT):

Mr. Dodd promised to introduce two bills today that would reorganize the F.D.A. and require drug makers to disclose the results of all clinical trials involving humans. The bills’ co-author, Senator Charles E. Grassley, Republican of Iowa, has called the agency far too “cozy” with drug makers.

Ummmm...from the article:

There are now thousands of drugs in routine use. Figuring out which of these medicines may have undiscovered side effects will take a lot of money. The agency gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the F.D.A. could use little of the money to track the safety of approved drugs.

That deal between the F.D.A. and drug makers expires this year, and the drug companies have agreed to allow more of their money to be used for postmarket safety assessments. Whether those fees are enough, whether there should be any strings attached to them and whether that money should be coming from drug makers at all has become the subject of fierce debate.

Fasten your seatbelts...(sorry, that's my "homage" to "All About Eve")! Click here to read the entire New York Times article (registration required).

Health literacy still an issue...

As reported in the New York Times article "The Importance of Knowing What the Doctor Is Talking About," health literacy, or rather the lack thereof, is an issue for all patients. How can patients comply with doctor's orders when they never understood them in the first place? Some tips from the article for patients:

Do not wait until doctors become better at communicating. If you want the best medical care, you have to take the initiative. If the doctor says something you do not understand, ask that it be repeated in simpler language. If you are given a new set of instructions, repeat them back to the doctor to confirm your understanding. If you are given a new device to use, demonstrate how you think you are to use it.

Insist that conversations about serious medical matters take place when you are dressed and in the doctor’s office. Take notes or take along an advocate who can take notes for you. Better yet, tape-record the conversation to replay it at home for you and your family or another doctor.

Click here to read the entire article (registration required).

HealthGrades names Distinguished Hospitals for Clinical Excellence

HealthGrades has issued their annual study on hospital quality and clinical excellence (now in its fifth year):

The 2007 study found that 158,264 lives may have been saved and 12,410 major complications avoided during the 3 years studied, had the quality of care at all hospitals matched the level of those in the top five percent. These major complications include problems like post-op pneumonia, post-op respiratory failure, post-op bacterial infections, or post-op bleeding.

To name hospitals in the top five percent for clinical excellence, the HealthGrades’ study analyzed nearly 39 million hospitalizations over the years 2003, 2004 and 2005 at all 4,971 of the nation’s nonfederal, nonchildren’s, short-term acute care hospitals.

Click here to read the press release on the study. Click here to access the general HealthGrades website.

Is pay for performance akin to the radical mastectomy procedure?

Check out the latest issue of the New England Journal of Medicine and read the article by Lindenauer, et al "Public Reporting and Pay for Performance
in Hospital Quality Improvement." Interesting, interesting results...

Also suggest y'all read the editorial "Pay for Performance at the Tipping Point" by Arnold M. Epstein, M.D. As Doctor Epstein points out in his editorial:

Given this dearth of solid evidence, it seems apt to compare our adoption of pay for performance with our adoption of new surgical procedures or medical therapies. Many of my clinical colleagues would insist on hard evidence documenting efficacy before endorsing a new therapeutic approach. They cite sobering stories of what can happen when we introduce new approaches prematurely. Consider, for example, the numerous surgical procedures or medical therapies — including radical mastectomy for women with early-stage breast cancer and hormone-replacement therapy for postmenopausal women — that were diffused widely before solid evidence of their relative efficacy was available, only for us to learn later that they were, at best, no more effective than alternative therapies or, at worst, harmful.8-10 If pay for performance were a therapy, its rapid diffusion thus far would have to be considered premature.

Click here to access these free, early release articles. Thanks, NEJM!

Talk about a conflict of interest?

According to the New York Times, Connecticut's attorney general has pressured a consulting group of hospital executives, the Healthcare Research and Development Institute (HRDI), to agree to "stop selling marketing advice to vendors who do millions of dollars in business with nonprofit hospitals across the nation, including their own." Gee, is that a conflict of interest? Duh!

The agreement, Mr. Blumenthal said, “shatters an anticompetitive, secret society, an elite and exclusive club of premier hospital executives and select hospital supply businesses that restrained competition to the detriment of patients and providers.”

The settlement, he said, did not end his investigation of hospital vendors.

H.R.D.I., which was founded five decades ago as an educational group, will change from a profit-making company into a nonprofit group financed only by hospitals or their executives. Supply companies may not initially join the new group, called the Health Education Network, nor will they be permitted to have any financial links to it.

The settlement, under which the group agreed to pay a $150,000 fine, ends a two-year investigation by Mr. Blumenthal, who found that some suppliers had increased their sales at hospitals run by H.R.D.I. members after paying consulting fees to those members, investigators said. The names of those vendors and hospitals were not included in the settlement agreement, which applied only to H.R.D.I. and not individual members.

Click here to read the entire article.

Harvard study shows rise in nicotine content in cigarettes

A study by the Harvard School of Public Health indicates that nicotine content in cigarettes rose by approximately 11 percent between 1998 and 2005. From the Thanhniennews.com article:

Nicotine yields rose in cigarettes of each of the four major manufacturers and across all major cigarette market categories – from mentholated and non-mentholated to full-flavored, light and ultralight, the study said.

Tobacco industry officials were not immediately available to comment. Phillip Morris, part of Altria Group Inc and the largest cigarette maker, has said nicotine levels fluctuate from year to year but there has been no steady increase.

Click here to read the entire article.

2007 Alliance conference

I attended the 2007 Alliance for CME conference held last week in Phoenix, AZ; as always, had a great time catching up with my CME colleagues. I spent some time at the Thursday night reception chatting with Patrick G. Moran, M.D., who also consults in CME. Doctor Moran is a Fellow of the ACME and just an absolutely delightful gentleman. I thank him for taking the time to visit with me and share some of his experiences over the years. While you might expect me to write about the sessions (the new ACCME criteria, evaluation, challenges, etc.), I'd rather tell you about the quality of people I personally know in CME. They work at all levels in CME; they have different backgrounds, education, and experience. One thing I know for certain (do I sound like Oprah?) is that CME is a good "place" because of the quality of the people who work there.

More on electronic prescribing

Here are some interesting statistics from the Time.com article "Cause of Death: Sloppy Doctors":

SureScripts CEO Kevin Hutchinson says one key to reducing medication errors is to get the most prolific prescribers to transition to electronic processing. "Not a lot of people understand that 15% of physicians in the U.S. write 50% of the prescription volume," Hutchinson says. "And 30% of them write 80%. So it's not about getting 100% of physicians to e-prescribe. It's about getting those key 30% who prescribe the most. Then you've automated the process."

Click here to read the entire article.

Free electronic prescribing for U.S. physicians

This is pretty interesting -- the National ePrescribing Patient Safety Initiative is a coalition of some tech companies and healthcare organizations seeking to improve patient safety. From their press release:

eRx NOW™ offers physicians and patients the highest levels of security available, with multiple redundant layers of firewall, deep-packet inspection, SSL encryption, database encryption, intrusion detection and virus, spyware and malware protection for the program’s remote servers. To ensure patient privacy, all patient information is stored on remote servers in a secure location, so information cannot be compromised even if a physician’s computer or phone is stolen.

Interested physicians can visit the NEPSI web site, www.nationaleRx.com to register for the program. The solution is currently being used by physicians and will begin national deployment within 30 days.

Click here to access the NEPSI website.

Bariatric surgery stats

Statistical Brief #23 from the Healthcare Cost and Utilization Project (HCUP) reveals the following interesting information on bariatric surgery in the United States:

From 1998 to 2004, the total number of bariatric surgeries increased nine-fold, from 13,386 to 121,055.

Across all age groups, the fastest growth in bariatric surgeries occurred among adults aged 55 to 64, a twentyfold increase, from 772 surgeries in 1998 to nearly 16,000 surgeries in 2004.

The national inpatient death rate associated with bariatric surgery declined 78.7 percent, from 0.89 percent in 1998 to 0.19 percent in 2004. In 2004, 230 patients died in hospital stays during which bariatric surgery was performed.

An increasing number of adolescents (12–17 years old) are receiving bariatric surgery, an estimated 349 in 2004.

Women accounted for 82.0 percent of all bariatric surgeries in 2004.

Click here to access this statistical brief. Click here to access HCUP's website; CME Providers might want to bookmark it.

ACCME posts toolkit to support implementation of the Updated Accreditation Criteria

Click here for toolkit.

Did Ernest gets his cat back?

Hercules (or Goliath) the cat went missing when his owner, Geoff Ernest of Portland, traveled to Seattle for a lung transplant a few months ago. How was Hercules found?...click here to view the video.

Will this improve quality of hospital care?

Looks like heart attack and heart failure death rates will be listed on Hospital Compare, a government website. From the USA Today article:

Some hospital administrators, though they support the goal, say the statistics may be misleading.

"It clearly needs to be done, but I'm not sure 30-day mortality is the right measure," says Gary Noskin of Northwestern Memorial Hospital in Chicago. "A patient could have a heart attack (and be treated successfully) and get hit by a bus after he leaves the hospital."

Medicare officials counter that the statistical methods used in the analyses highlight patterns of care, good or bad, not individual cases. The approach was approved by the National Quality Forum, a consortium of professional organizations, businesses, consumer groups, hospital chains and health plans.

Hospital Compare is an interesting website and I think CME Providers should be aware of the information it contains. Click here to read the entire article.

Two national healthcare reports issued

The Department of Health & Human Services and the Agency for Healthcare Research and Quality issued the results of the 2006 National Healthcare Quality Report and National Healthcare Disparities Report. Both of these reports found that use of proven prevention strategies needs to be improved:

Fewer than half of obese adults reported being counseled about diet by a health care professional. About one-third of American adults are obese, increasing the risks of high blood pressure, type 2 diabetes, stroke, heart disease and osteoarthritis. The Task Force recommends "intensive counseling and behavioral interventions" for obese adults.

Only 48 percent of adults with diabetes received all three recommended screenings—blood sugar tests, foot exams and eye exams—to prevent disease complications. AHRQ estimates about $2.5 billion could be saved each year by eliminating hospitalizations related to diabetes complications.

On a bright note, the National Healthcare Quality Report found that quality has improved for hospital care for heart attack patients by 15 percent and by 11.7 percent for pneumonia patients. Click here to read the entire press release. Click here for the National Healthcare Quality Report, and here for the National Healthcare Disparities Report. Okay, that's enough clicking for a Friday!
:)

Bush would veto legislation for Federal negotiation of Medicare drug prices

The word from the White House Office of Management and Budget is that President Bush would veto any legislation that would rescind the current noninterference clause in the Medicare prescription-drug law. In addition, this information from the same MarketWatch.com article:

The Health and Human Services Department on Monday released new figures showing that the estimated cost of the drug plan were lower than originally anticipated, thanks to competition between drug-plan providers.

The administration now expects the drug benefit to cost $640 billion between 2006 and 2015, down from its initial estimate of $926 billion.

Click here to read the entire article.

Doctors and dying...new book

William Grimes, in the New York Times, reviews "Final Exam," a new book written by Pauline W. Chen, M.D. From the review:

Outside the conferences, death is the unwelcome, awkward visitor who stops conversation. Dr. Chen cites a survey showing that one-quarter of oncologists failed to tell their patients that they were suffering from an incurable disease. Nearly half of the doctors in another study rated themselves as “poor” or “fair” in breaking bad news to their patients. Often, with several specialists and sub-specialists assigned to a dying patient, each doctor waits for the other to provide unwelcome information.

Dr. Chen experiences an epiphany when she witnesses a break with tradition. Normally, in a patient’s final hours, doctors close the curtain around the bed and disappear, leaving family members alone with their dying relative. But one doctor, trying to console an elderly woman whose husband is dying, stays with her by the side of the bed. As she holds her husband’s hand, he tells her what the strange sights and sounds on the monitors are saying, and what her husband is experiencing as life ebbs away. That scene of compassion and communication, in the midst of high-tech beepings and buzzings, shows what doctors can do when nothing can be done.

Click here to read the entire review.

Arnie's health care reform plan

California Governor Arnold Schwarzenegger (who is recovering from a broken leg) has announced a health care reform plan which will require coverage for all Californians:

Speaking about his plan for the first time via a video link to a meeting of healthcare stakeholders, Governor Schwarzenegger said this was not a question of whether everyone should be covered, the legislation already says they must, but a matter of how to pay for it. He is proposing to spread the cost among individuals, businesses, insureres, government, and healthcare providers.

Under his scheme, all citizens will have to be insured, with the poorest being helped through subsidies. One of the biggest shocks will come to the small and medium business sector, where those employing 10 people or more will either have to offer insurance to their employees or pay 4 per cent of their payroll to a state scheme. Hospitals will also have to pay 4 per cent of their income, and doctors 2 per cent.

Click here to read the entire article.

Brain hemorrhages associated with warfarin use on the rise

A study just published in the January 9, 2007 issue of Neurology reports a ten-fold increase in the incidence of brain bleeds in patients using warfarin. From the article:

"Warfarin use increased during the 1990s, because it was proven to be effective in preventing ischemic strokes among people who have an abnormal heart rhythm called atrial fibrillation," said the study's lead author, Dr. Matthew L. Flaherty, a neurologist.
...
Flaherty thinks that doctors need to be cautious in prescribing warfarin, especially to patients over 80. "Some of those patients are better off being on warfarin," he said. "The message isn't that no one should use warfarin. There needs to be a balance between the benefit of preventing ischemic stroke and the risk of bleeding."

Click here to read the Forbes.com article.

Physician executives burned out?

The American College of Physician Executives surveyed 1,200 physician executives about their current morale, and the survey results were published in the November/December 2006 issue of The Physician Executive. Here are some of the survey results:

Low reimbursement rates and loss of autonomy were the top two reasons for poor morale.

Bureaucratic red tape, patient overload, loss of respect and the medical liability environment were among the other reasons physicians cited.

Those work problems caused fatigue in 77% of physicians, emotional burnout in 67% and marital/family discord or depression in about one in three physician respondents.

Click here to read the AMNEWS article (a subscription is required to read the entire article).

Review of 2006 health issues by WHO

Click here to view a slide presentation prepared by the World Health Organization on 2006 health issues. It provides information on major world health topics from AIDS to XDR TB.

"Dr. New York"

Read a great article in the New York Times on Dr. Herbert Pardes who is President of the NewYork-Presbyterian Healthcare System. The historical information in the article is fascinating as is the delineation of the challenges inherent in trying to bring two major health care institutions into one system. From the article:

In taking the helm of NewYork-Presbyterian, Dr. Pardes, the nation’s first psychiatrist to run a major medical center and hospital, encountered a corporate version of a dispirited patient plopped on his sofa. The merged entity he inherited was gargantuan, its work force able to fill three Madison Square Gardens. Its organizational chart — with 52 hospitals, nursing facilities and specialty care centers and five campuses — was labyrinthine.

Dr. Pardes’s turnaround strategy, by comparison, was relatively simple: restructure the management team to make hospital administrators more nimble and accountable for performance, root out excessive spending to improve profit margins and bolster revenue by becoming the hospital of choice in the city.

As it turned out, the hospital’s most dire issue was cultural, Dr. Pardes said. Worried about losing power in the merged enterprise, for example, physicians from each predecessor hospital had banded together and refused to relinquish any area of care to the other hospital. Dr. Pardes was witnessing similar tensions play out in 1998 when Mount Sinai and New York University Hospital fused their medical schools.

Click here to read the article.

American Society of Hypertension will include COI panel

ASH has reversed its decision to cut a panel discussion on industry influence on medicine from its May 2007 conference agenda:

The society said the original session, titled "Conflicts of Interest," was kept off the agenda of its annual meeting because the proposed lineup of panelists lacked balance.

After the cancellation was reported by the Globe last week, the society's associate executive director, Melissa Levine , said in an e-mail that the society had now decided to add the panel discussion to the agenda for the May meeting in Chicago.

The society is "committed to conducting a session on conflicts of interest," Levine said. "Over the next few weeks we will be working to finalize the session and confirm the speakers."

But the inclusion of drug industry defenders led one of the original invited panelists, Dr. Marcia Angell , former editor of the New England Journal of Medicine, to question the society's motives, even though she is considering taking part in the session.

Click here to read the most recent Boston Globe article on this news item.

New W.H.O. director general

She is Dr. Margaret F. C. Chan, a graduate of the medical school of the University of Western Ontario in Canada and a former Hong Kong health chief. Dr. Chan was appointed director general in November 2006 and her term will end June 2012. Dr. Chan identified two major goals for her new role as W.H.O. director general -- "to improve the health of Africans and of women throughout the world." More from the New York Times article:

“Women do much more than have babies,” Dr. Chan said in a statement on the agency’s Web site. Speaking to reporters yesterday by telephone from the health organization’s headquarters in Geneva, she added that women were a rising influence in the work force and in their communities — particularly since so many teachers and health care workers were women.
...
Dr. Chan is the first person from China to head a United Nations agency. China has been criticized severely for not sharing information with the world about diseases like influenza and SARS, or severe acute respiratory syndrome. Asked whether she felt pressure to favor China, Dr. Chan pledged to be fair, transparent and accountable. “As an international civil servant, I commit to serve the interests of the member states of the organization,” she said.

“When the evidence is clear and health is at stake, the director general must be prepared to take a stand on difficult, and at times political, issues that affect health,” she said.

Click here to read the New York Times article.

IFPMA issues press release on new marketing code

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) issued a recent press release on their new marketing code which became effective January 1, 2007:

The new Code, whose applicability extends to every country and is required of all IFPMA members, imposes even stricter and clearer requirements on pharmaceutical companies, to ensure the ethical promotion of their products to health care professionals.

IFPMA Director General Dr. Harvey E. Bale said: “The updated provisions of our new Code reflect the industry’s concern to underscore that its life-saving products are promoted in an ethical manner. They apply in every country around the world, and we have taken particular care to prepare member associations and companies for the advent of the new Code; indeed, we started communicating it to them back in June of last year, to ensure they would have adequate time to prepare for its stricter provisions regarding international events, company sponsorship of health care professionals, the provision of hospitality and entertainment, as well as its more precise definitions of acceptable gifts.”

Click here for the press release and click here for the English version of the new code. Will this new code make it easier to comply with the ACCME Standards for Commercial Support of CME when CME activities take place in non-U.S. countries?

Additional settlement from Lilly

Eli Lilly has agreed to settle 18,000 lawsuits on Zyprexa and pay out $500 million. This is in addition to the lawsuits they previously agreed to settle, which now brings Lilly settlement costs on Zyprexa lawsuits to $1.2 billion. From the New York Times article:

"The documents also show that Lilly marketed the drug as appropriate for patients who did not meet accepted diagnoses of schizophrenia or bipolar disorder, Zyprexa’s only approved uses. By law, drug makers may promote their drugs only for diseases for which the Food and Drug Administration has found the medicines to be safe and effective, though doctors may prescribe drugs in any way they see fit.

In response to questions about the information in the documents, Lilly has denied any wrongdoing and said it provided all relevant information to doctors and the F.D.A. Lilly has also said it did not promote Zyprexa for conditions other than schizophrenia or bipolar disorder."

Apparently there are more Zyprexa lawsuits pending. Click here to read the entire article. It would be interesting to know exactly how Lilly allegedly promoted off-label uses of Zyprexa -- do the "documents" include certified CME activities?

2007 Childhood and Adolescent Immunization Schedules

Practice guidelines relative to the 2007 childhood and adolescent immunization schedules have been published in the American Family Physician. The guideline source: Advisory Committee on Immunization Practices, American Academy of Pediatrics, American Academy of Family Physicians. "Published sources: Morbidity and Mortality Weekly Report, January 2007; Pediatrics, January 2007; American Family Physician, January 1, 2007." Click here to access these practice guidelines.

To read an editorial on the HPV vaccine written by Jonathan L. Temte, M.D., PH.D., University of Wisconsin School of Medicine and Public Health, click here.

The medicalization of life

Everyone has an opinion and the authors of this New York Times essay -- "What’s Making Us Sick Is an Epidemic of Diagnoses" -- certainly have theirs. They do make some good points on which to ponder:

"For most Americans, the biggest health threat is not avian flu, West Nile or mad cow disease. It’s our health-care system.

You might think this is because doctors make mistakes (we do make mistakes). But you can’t be a victim of medical error if you are not in the system. The larger threat posed by American medicine is that more and more of us are being drawn into the system not because of an epidemic of disease, but because of an epidemic of diagnoses.

Americans live longer than ever, yet more of us are told we are sick.

How can this be? One reason is that we devote more resources to medical care than any other country. Some of this investment is productive, curing disease and alleviating suffering. But it also leads to more diagnoses, a trend that has become an epidemic."

Click here to read the entire essay.

Diatribe on pharma sales reps?

It may sound like the title of a B movie, but "Attack of the Pharma Babes," a Time article written by Dr. Scott Haig gives one doctor's perspective on pharma sales reps, DTC advertising, HMOs, and hospitals. He might even make you crack a smile. Click here to read the article.

1st-year residents and preventable medical errors

A study by the Agency for Healthcare Research and Quality and the National Institute for Occupational Safety and Health revealed there is a 300 percent rise in the chances of first-year residents making preventable adverse events when they work five extended shifts (24 hrs or more) in one month's time. From the press release:

"Laura K. Barger, Ph.D., a research associate in medicine at Brigham and Women's Hospital and Harvard Medical School in Boston, and her colleagues analyzed the results of a national, Web-based survey in which 2,737 interns completed 17,003 monthly reports. Researchers assessed the association between the number of extended-duration shifts worked in the month and the reporting of significant medical errors, preventable adverse events, and attentional failures.

The findings are significant because interns routinely work extended shifts in teaching hospitals. Guidelines for graduate medical education in the United States still allow up to nine "marathon" shifts (30 hours at a stretch) per month, even though the total number of hours worked is capped. This study shows that the long shifts worked by interns are bad for patient safety, as they are more likely to cause harm that would not otherwise happen."

Leist named Alliance Interim Executive Director

Harry A. Gallis MD, President, Alliance for CME just announced via the Alliance member listserve that he has appointed James Leist, EdD, as the interim Executive Director. Jim will begin his duties on February 1, 2007. Please join me in congratulating Jim on this appointment.
:)

Smoking cessation by story

The power of story is now being used in anti-smoking advertisements, as reported in a recent New York Times article:

"Antismoking ads have changed a lot from the days when commercials gloomily listed health risk after health risk in an attempt to persuade smokers they should quit. Most smokers already know they should quit, and they usually try to do so eight times before they succeed, according to the American Legacy Foundation, a nonprofit group that fights smoking.

Messages from real people seem to be more persuasive to smokers, the foundation says. In 2006, the foundation continued its Truth campaign aimed at deterring teenagers from smoking with documentary-style commercials featuring a bushy-haired young man investigating the tobacco industry in an aggressive but funny manner."

The article also discusses the advertisement of smoking cessation products which includes telling the stories of real people who are trying to quit smoking. Click here for the full article.