Malpractice insurance price gouging?

According to a new report issued by the American Association for Justice the answer is "yes": from the press release:

Written by former Missouri Insurance Commissioner Jay Angoff, the study is based on recent annual reports from the top 15 medical malpractice insurers as rated by A.M. Best. The report shows that these insurers artificially raised doctors’ premiums and misled the public about the nature of malpractice claims – asserting that a so-called “malpractice crisis” exists. The report puts the lie to that claim.

According to the study:

The medical malpractice insurers saw losses and projected losses plummet by 48% over the period 2003-2006.
These incurred losses have declined every year for the past five years. These insurers’ 2006 surplus is 43% greater than their surplus in 2003 – five times the state-minimum surplus for insurer stability.
Only three of the 15 leading insurers issued dividends to doctors in 2006.

“Medical malpractice insurance companies have been price-gouging doctors, padding their pockets with excessive premiums and driving up the cost of healthcare,” said Jon Haber, AAJ Chief Executive Officer. “Cynically, these same insurance companies have been blaming high premiums on a so-called ‘malpractice crisis’ that doesn’t exist. We have an insurance crisis, not a medical malpractice crisis.”

Click here to read the entire press release. Click here to access the AAJ report (that graph on page 3 says it all).

hospitalcompare.hhs.gov

As reported in the USA Today article, beginning in June, "the Centers for Medicare and Medicaid Services (CMS) plans to post the first broad comparison of the death rates for heart attack and heart failure on its website, Hospital Compare." From the article:

The federal initiative marks a bold departure for an agency that has long been the repository of private information on Medicare patients. More than a dozen top hospitals provided USA TODAY with an exclusive look at the government's initiative by sharing their confidential Medicare death-rate report cards. The reports are drawn from death rates of heart attack and heart failure patients who died between July 2005 and June 2006, of any cause, within a month of entering the hospital.

The analysis reveals just 17 of 4,477 hospitals had heart attack death rates that were better than the national rate. Thirty-eight of 4,804 hospitals had heart failure death rates that were better than the national rate.

There was cause for alarm, too. The analysis reveals 42 hospitals where patients are more likely to die from heart attacks and heart failure than patients who go elsewhere, including at least one whose 24% heart attack death rate topped the national rate by nearly 10 percentage points.

Click here to read the entire article.

Data sources on health facts

Ever wonder how many U.S. states have firearm laws designed to protect children? Then check out statehealthfacts.org.

Did you know that, globally, in 2005 there were 8,810,805 new cases of TB? Do you know which three countries led the world in new cases of TB? Check out globalhealthfacts.org.

AMA Therapeutic Insights released (eCME activity)

From the PRNewswire press release:

The AMA is collaborating with recognized disease experts, national data providers and medical specialty groups to incorporate unique drug therapy information, disease prevalence and practice guidelines into an educational delivery format. The prescribing data included in AMA Therapeutic Insights are provided by IMS Health. The data are fully compliant with federal privacy standards and do not contain any patient identifiable information.

Physicians interested in continuing medical education can access AMA Therapeutic Insights to earn AMA PRA Category 1 Credit(TM) that can be applied toward the Physician Recognition Award (PRA).

Click here to read the press release. Click here to access AMA Therapeutic Insights.

Loose lips...

From the theheart.org article:

The American College of Cardiology (ACC) is formally penalizing Dr Martin Leon (Columbia University, New York, NY) for remarks about the COURAGE trial, made openly at an industry-sponsored symposium, that the organization says were in violation of an embargo on public disclosure of the trial's outcomes. The sanctions will include public censure and restrictions on his participation in the group's scientific sessions next year, the ACC announced today.

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

The Nissen "Net" that caught Avandia

That'd be Cleveland Clinic's cardiology chief, Dr. Steven Nissen, who is also the immediate past president of the American College of Cardiology. From the Houston Chronicle article:

...review of dozens of studies showed the drug, taken by millions of diabetics, significantly raises the risk of heart attack. Six days later, he submitted the paper to the New England Journal of Medicine, which moved "at lightning speed" to get it out on Monday.

"I felt I had an ethical and a moral obligation to work as fast as I could," Nissen said.

He previously warned of heart risks from the painkiller Vioxx, which was pulled off the market in 2004, and three other drugs that nearly won approval: the diabetes drug Pargluva, the anticoagulant Exanta and the blood pressure drug Vanlev. He was the only FDA adviser to vote against Natrecor, a heart failure drug that some research has tied to a risk of death.

"I didn't really ask for this role," Nissen said. "I would rather spend my time doing studies that develop medications. But what happened was the FDA seems to have lost its way, and seems to be incapable of monitoring drug safety adequately. So it's fallen upon individuals to do independent analyses. I would love for that to change."

Click here to read the entire article.

Let's all take a deep breath...

From the Wall Street Journal article on Avandia "What Diabetes Patients Need to Know":

In a joint statement, the American Heart Association, American College of Cardiology and American Diabetes Association said the study "deserves serious thought and follow up" though the overall level of risk associated with the drug "appears to be small." The groups said patients should not stop taking any prescribed drugs without talking with their health-care providers.

Dr. Kirkman of the American Diabetes Association noted that diabetics are at a high risk for cardiovascular problems. However, she said, "We don't feel that this is an emergency or a panic situation, and we certainly don't advise that people go off medication without talking to their health-care provider about alternatives," she says.

Richard Hellman, president of the American Association of Clinical Endocrinologists, said Dr. Nissen's study raises the possibility that certain patients, such as those who have heart disease, may be at especially high risk. He said, the association isn't recommending that doctors stop prescribing Avandia altogether.

Click here to access the WSJ article (subscription required).

Too much, too soon?

Looks like states are backing away from making the cervical cancer vaccination mandatory. From the courant.com article:

Combine national wariness with a vaccine that costs more than any other in U.S. history; skimpy or non-existent insurance payments to doctors; and concern from social conservatives that a vaccine to prevent a sexually transmitted disease might promote promiscuity, and efforts to mandate the HPV vaccine ended up on the legislative back burner.

On top of all that, while cervical cancer remains a serious disease, it is not a public health crisis in the United States.

However, the article makes an important point:

Last week, a newly published study linked the HPV virus to certain types of throat cancer among people infected through oral sex. The incidence of oral cancer has not dropped in the United States, despite a decline in the major risk factor, smoking, leading researchers to suspect that HPV might be a culprit.

Given the reported popularity of oral sex among teens (Centers for Disease Control), there may be a public health crisis brewing; I offer that research on the etiology of these types of throat cancer is needed quickly. Click here to read the courant.com article.

Good health for SiCKO?

Michael Moore's new film, SiCKO, was shown at the Cannes Film Festival over the weekend; from a review:

Pic's tone alternates between comedy, poignancy and outrage as it compares the U.S system of care to other countries. Given Moore's celebrity and fan base, plus heightened awareness of the pic resulting from the heated battle that's already begun between left and right, returns look to be extremely healthy.

Pic should also play well internationally, providing an eye-opening lesson for foreigners who may be inclined (like Moore's Canadian cousins) to take out insurance from their homeland before visiting the States.

Chief criticism of the film is that it paints too rosy a picture of the national health care of the countries he compares America to, including Canada, England, France -- and Cuba.

Click here to read the entire review.

Another reasonable voice

Scott Lassman, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, sounded off in the Boston Globe this past Friday:

The information exchange also goes both ways. Doctors learn firsthand the trends in medicine safety before anyone else in the medical community. It's the kind of experiential knowledge that can't be taught in the university or even learned in a lab, and they share their experiences with a given medicine with these representatives.

This debate is really about trust. The industry values the relationship its representatives have built with the nation's healthcare professionals, and it is critical to the mission of helping patients that these interactions be maintained at the highest ethical standards. Just as patients trust their physician, it is equally important that physicians trust their pharmaceutical representatives.

Click here to read the entire article.

A reasonable voice

This essay didn't make it into one of the big newspapers; however, it deserves a wider forum, from the Daily News Tribune:

Current medical journals and the popular press carry numerous articles about the relationships between the drug manufacturing industry and physicians. Newspapers and computer screens roar with disturbing headlines: ``Doctors reap millions for anemia drugs;'' ``Pills for Patients, Payday for Docs;'' ``Posing as pals, drug reps sway doctors' choices.''

The perception of physicians created by these stories raises many questions. It often appears that physicians and pharmaceutical companies are engaged in an unholy alliance where greed and money rule. Some reports would have you believe most doctors are checking patients with one hand and looking for a hand-out with the other.

It's true some physicians (as well as drug company representatives) may lose their ethical compass from time to time. Thankfully, the overwhelming percentage of my profession is populated with good, honest, decent and wonderfully caring people.

Click here to read this essay written by Leonard J. Morse, M.D.

Advances in medical technology

On the theme of new medical technology and its associated monetary costs, here are a couple of other news items y'all might want to check out:

The Baltimore Sun article "Medical Scans Zapping Insurers":

The upshot: Imaging has nudged out drugs as the fastest growing component of rising medical costs, increasing as much as 20 percent a year.

The overall cost of diagnostic imaging is estimated at well over $100 billion annually in the United States. That's about a nickel of each health spending dollar.

That's gotten the attention of insurers, who have put up more hurdles and imposed more controls, creating hassles for doctors and patients alike. Sometimes they refuse to pay at all.

The courant.com article "Doctors Balk At Small Fee For Injecting Costly Vaccine":

Doctors report a brisk demand for the vaccine, which blocks strains of the ubiquitous human papillomavirus (HPV) that cause 70 percent of cervical cancers.

But some doctors, especially pediatricians and gynecologists, who are most likely to be asked for the vaccine, are refusing to buy it or restricting who receives the shots.

Discontent over the price of the vaccine - the most expensive ever - highlights a long-simmering dispute over reimbursement for immunizations, traditionally regarded as bedrock medicine. It is a dispute, experts say, with significant public health implications that has accelerated as the number of costly new vaccines has proliferated.

No doctor in the OR!

From the Tennessean.com article:

Imagine going to the hospital for surgery, but there's no doctor in the operating room.

Instead, there's a robot, controlled by a doctor in some other city.

The breakthrough that makes that possible is among the technology on display at the 12th annual meeting of the American Telemedicine Association. The meet, which began Sunday, ends today at the Gaylord Opryland Resort & Convention Center.

The event drew about 120 exhibitors, including the makers of a robot that lets doctors interact with patients from miles away, and of machines that can be used to check on patients in their homes and record their blood pressure and other vital signs.

The article points out that insurance (lack of reimbursement) can be a barrier to telemedicine. Click here to read the entire article.

"Engaging" sales reps result in more scripts

From the PRNewswire press release:

The puzzle of why physicians make different prescribing decisions is a complex one. Many companies invest solely in research that assesses sales representative performance from the physician perspective. Such research often examines only the functional aspects of the detail process. PeopleMetrics research finds that the engagement level of the representative and their passion for the company is an overlooked but critical piece to this puzzle. Pharmaceutical companies that measure and improve sales representative engagement thereby position their sales force to build stronger relationships with physicians.

Gosh, what a surprise! Click here to read the entire press release.

Walkin' and workin'...

This is so cool! A physician at the Mayo Clinic just finished a small study (n=15) in which obese folks worked on a special computer-treadmill station:

Levine didn't measure actual weight loss. This is a theoretical study, but he calculates that burning an extra 100 or more calories an hour for two or three hours each working day would cause many obese people to lose between 20 and 30 kilograms a year.

The "walk and work" device is no ordinary treadmill.

It's built on a steel frame with four wheels, so that workers can steer it around the office.

There's room for a computer, books, pens, a phone, a flower vase, coffee cup and paper tray. The whole thing slides over a standard treadmill, or slides away when the user wants to stand on a solid floor.

It can also slide over to a chair so that the user doesn't have to stand for the entire day. Mr. Levine says it costs about $1,600 US, not including the treadmill - a bargain, he suggests, since obesity costs the U.S. $100-billion to $200-billion a year in health costs and lost productivity.

Click here to read the entire article.

Dietary supplements...what residents don't know

Interesting study just published in the Archives of Internal Medicine on physician knowledge of dietary supplements and FDA regulation (or lack thereof):

Baseline knowledge of dietary supplement regulatory issues was poor. The total average pretest score was only 59% (986/1675). The average score rose to 91% (1526/1675) after completion of the curriculum (P<.001). With regard to specific content areas, about one third of physicians were unaware that dietary supplements did not require FDA approval or submission of safety and efficacy data before being marketed. Similar percentages believed that there are regulations in place to ensure supplement quality. Most physicians were unaware that serious adverse events due to the use of supplements should be reported through the FDA MedWatch system.

Click here to access the abstract.

New TIA diagnostic protocol

From the ACEP News Release:

A new emergency department diagnostic protocol shows potential for saving money and time, as well as for dramatically reducing the number of hospital admissions for patients diagnosed with transient ischemic attack (TIA), or stroke. The study appears online in the Annals of Emergency Medicine ("An emergency department diagnostic protocol for patients with transient ischemic attack: a randomized controlled trial").

"Because TIAs tend to be so predictive of future, more serious strokes, many within a couple of days, emergency physicians hospitalize most TIA patients," said lead study author Michael A. Ross, MD, of William Beaumont Hospital in Royal Oak, Michigan. "By managing TIA patients using an accelerated diagnostic protocol in the emergency department, we were able to cut most patients' length of stays and costs in half without compromising their 90-day clinical outcomes. Besides freeing up inpatient beds, this should lead to greater patient satisfaction."

Click here to read the entire news release.

Atypical psychiatrists?

From the New York Times article:

The psychiatrist receiving the most from drug companies was Dr. Annette M. Smick, who lives outside Rochester, Minn., and was paid more than $689,000 by drug makers from 1998 to 2004. At one point Dr. Smick was doing so many sponsored talks that “it was hard for me to find time to see patients in my clinical practice,” she said.

Dr. Steven S. Sharfstein, immediate past president of the American Psychiatric Association, said psychiatrists have become too cozy with drug makers. One example of this, he said, involves Lexapro, made by Forest Laboratories, which is now the most widely used antidepressant in the country even though there are cheaper alternatives, including generic versions of Prozac.

Click here to read the entire article.

Purdue pain

From the New York Times article:

The company that makes the narcotic painkiller OxyContin and three current and former executives pleaded guilty today in federal court here to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused.

To resolve criminal and civil charges related to the drug’s “misbranding”, the parent of Purdue Pharma, the company that markets OxyContin, agreed to pay more than $600 million in fines. That is the third-highest amount ever paid by a drug company in such a case.

Also, in a rare move, three executives of Purdue Pharma, including its president and it top lawyer, pleaded guilty today as individuals to misbranding charges, a criminal violation. They agreed to pay a total of $34.5 million in fines.

Click here to read the entire article.

More on anemia drugs

From the Wall Street Journal:

A Food and Drug Administration advisory committee said that cancer patients' use of popular anemia drugs made by Amgen Inc. and Johnson & Johnson should be limited further, and the companies should be required to complete studies to answer lingering safety questions.

The votes were a blow to the class of medications that the FDA calls erythropoiesis-stimulating agents, sometimes known as ESAs or EPO drugs, which are sold as Epogen and Aranesp by Amgen and Procrit by J&J. The medications are prescribed for anemia, which is a deficiency of red blood cells that can occur as a side effect of cancer chemotherapy and kidney disease.

Click here to read the WSJ article (subscription required).

Earlier in the week, the New York Times published an article on rebates to oncologists on these anemia drugs:

Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.
...
Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment.

Click here to read the NYT article.

Gender gap in health care

Make a note, ladies, now we not only make less than men for doing the same job but we don't receive the same level of health care. That's the finding according to a study done by the Health and Human Services' Agency for Healthcare Research and Quality (using 2004 data). From the United Press International article:

Women were 47 percent more likely than men to be hospitalized for high blood pressure, an event that can usually be avoided with good primary care, the study said, and 50 percent of women receive recommended colorectal cancer screening, compared to 54 percent of men.

Click here to read this short article (and don't be shocked by that photo of Imus; methinks someone has a sense of humor).

More power to the FDA?

If the bill reauthorizing FDA user fees passes Congress, as expected, then it most likely will bring "sidecar" regulations for Pharma. From the Wall Street Journal:

If it becomes law, the Senate bill, called the Food and Drug Administration Revitalization Act, could shift the balance of power between regulators and the pharmaceutical industry. It requires the FDA to monitor drugs after they go on the market and provides new funding for that job. The bill would also require companies to make public the results from many of their studies.

The measure would grant the FDA authority to take major actions, including requiring new studies, limiting distribution or ordering label changes if the agency thought they were necessary. Currently, the FDA's authority in that area isn't clearly delineated, so the agency often has to negotiate with companies, using its leverage before it grants approval for a new drug or the indirect threat of its bully-pulpit power to get the concessions it seeks.

Click here to access the article (subscription required).

"150 consecutive daily entries on innovation"

Be certain to check out Doctor Reece's blog on medical innovations! Wednesday, May 9, 2007 marks 150 entries -- maybe you will read something you will want to put into practice. Click here to access his blog.

Influenza-Associated Pediatric Mortality and the Increase of Staphylococcus aureus co-infection

Click here to read this CDC Health Advisory.

Just say "no" to cancer prevention?

I have to admit that when I think of the issue of HPV vaccination from a public health perspective, it's a slam dunk! However, if I had a young daughter, would I race her into the doctor's office to be vaccinated? Professor R. Alta Charo discusses the issues surrounding HPV vaccination in the latest issue of the New England Journal of Medicine:

Cancer prevention has fallen victim to the culture wars. Throughout the United States, state legislatures are scrambling to respond to the availability of Merck's human papillomavirus (HPV) vaccine, Gardasil, and to the likely introduction of GlaxoSmithKline's not-yet-approved HPV vaccine, Cervarix, which have been shown to be effective in preventing infection with HPV strains that cause about 70% of cases of cervical cancer. At the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP) has voted unanimously to recommend that girls 11 and 12 years of age receive the vaccine, and the CDC has added Gardasil to its Vaccines for Children Program, which provides free immunizations to impoverished or underserved children.

Yet despite this federal imprimatur, access to these vaccines has already become more a political than a public health question. Though the more important focus might be on the high cost of the vaccines — a cost that poses a genuine obstacle to patients, physicians, and insurers — concern has focused instead on a purported interference in family life and sexual mores.

Click here to read the entire full free-text article (registration required).

The hip joint's connected to the pocketbook?

From The Star Ledger article:

For two years, federal prosecutors in New Jersey have been building a case that the nation's largest makers of artificial hips and knees defrauded the government and taxpayers by paying surgeons to use and promote their products, according to sources close to the probe.

The evidence includes statements from prominent doctors around the country who allegedly accepted lavish vacations, gifts and "consulting fees" as high as $200,000 a year from the implant makers for little or no work, said four attorneys who have been briefed on aspects of the case.

There is no allegation that the practice jeopardized patients or subjected them to substandard products or treatment. But the sources say prosecutors contend that the money had a sole purpose -- to buy surgeons' loyalty to specific products -- and that doctors often failed to reveal such a conflict to their patients. If true, such payments would violate the federal anti-kickback statutes that govern hospitals and health professionals who participate in Medicare.

Click here to read the entire article.

Chronic Obstructive Pulmonary Disease

From the Wall Street Journal article:

Former smokers may believe they are out of the woods because they quit, but nearly half of COPD patients are former smokers rather than current smokers, according to Amy Pianalto, project director of the NHBLI's "Learn More, Breathe Better" awareness campaign (www.learnaboutCOPD.org), which is sponsoring radio and print ads and offers materials for both doctors and patients.

Second-hand smoke, air pollution and workplace exposure to pollutants like chemicals, dust and fumes can also trigger the disease. An estimated 100,000 Americans also have a genetic disorder known as alpha-1 antitrypsin, or AAT, deficiency that makes them susceptible even without any kind of exposure.

"There are 12 million people in this country who are coughing and can't breathe who don't know they have COPD," says Molly McGuire, administrator of the nonprofit COPD Foundation (COPDFoundation.org). "It has been a slow process getting everyone connected to resources."

Click here to read the article (subscription required). Speaker resources on this topic are available here.

ACCME post re: Senate Finance Committee letter

From the ACCME's website:

The Senate Committee on Finance has provided the ACCME and the CME system with many face- and content-valid observations where enhancements could be implemented that would make the independence of CME from commercial interests more distinct. Since the development of the first version of the ACCME Standards for Commercial Support in the late 1980s, the ACCME has taken seriously its roles and responsibilities to set expectations about this independence of CME and to measure CME providers’ compliance with those expectations, especially in the presence of funds from commercial interests.

In this same spirit, the ACCME will reflect on the Senate Committee on Finance’s observations. The timing and process for this consideration matches well with the ACCME’s current process of review and assessment of the implementation of the 2004 ACCME Standards for Commercial Support: Standards to Ensure Independence. As these updated Standards are now in place across the CME system, the ACCME looks forward to determining where and how improvements to the accreditation policies and processes might strengthen the validity and independence of CME.

Click here to access.

FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

Click here to read the FDA's statement.

Lilly lifting the veil

Eli Lilly & Co. announced that it will be publicly disclosing which organizations receive grant funding from the company. From the Wall Street Journal article:

Lilly's decision to disclose its grants was prompted in part by an investigation into drug company donations by the Senate Finance Committee. The committee's report last week said while there is separation between grants and sales and marketing, potential for abuse remains. Some Eli Lilly executives had worried revealing the company's grants could expose recipients to criticism and bring more scrutiny. But ultimately, Lilly decided to disclose the details after an internal analysis showed the marketing department wasn't influencing the grant office's decisions, says Michael Bigelow, Lilly's assistant general counsel. Lilly shouldn't have to feel "apologetic" about the grants, he adds.

Click here to read the article (subscription required).

Fasten your seatbelts

The Senate Finance Committe just sent a letter to the ACCME urging "greater oversight by the council" per the press release. An excerpt from the letter:

Based on our analysis of the information you provided, we find it interesting that, even though ACCME's reaccreditation process relies almost exclusively on information supplied by the CME providers under review, ACCME still detects a significant number of incidences of noncompliance. It also appears that compliance with ACCME standards still allows CME providers to accommodate the business interests of their commercial sponsors and affords drug companies the ability to target their grant funding at programs likely to support sales of their products. The full extent to which drug companies influence the content of putatively independent CME programs cannot be estimated from the information we currently have.

Click here to read the press release and letter. And don't forget to participate in the Medical Meetings magazine survey on this topic -- click here to access.

Free prescription drug samples - good idea or bad idea?

From today's New York Times article:

The crackdown on free samples comes amid growing concern about the close ties between physicians and drug companies. Critics like Dr. Rothman say physicians don’t realize the extent to which their medical judgment is influenced by their acceptance of the samples. They point to studies like a 2002 paper in the journal Annals of Family Medicine finding that the number of doctors who treated high blood pressure with the “first line” drugs recommended by national guidelines was low, but increased sharply when free samples were removed.

So far, the University of Michigan Health System has banned free samples altogether, and the University of Pennsylvania and Stanford University medical schools have prohibited staff members from accepting them (though samples can be given to Stanford’s pharmacy for use in free clinics).
...
But there’s an upside to the samples. Using samples, a doctor can see if a patient can tolerate a new medication before the patient goes out and buys a 30-day supply. Physicians who treat poor people like to have samples on hand for them, and for uninsured patients.

Click here to read the entire article.

NH prescription data law interrupted...

A U.S. District Court judge on Monday overturned a New Hampshire law that was the first in the nation to ban the commercial use of information on what drugs physicians prescribe.

Judge Paul Barbadoro of the U.S. District Court in Concord ruled in favor of IMS Health Inc. (RX.N: Quote, Profile, Research and Verispan, two companies that collect prescription data from pharmacies and sell it to drug makers, researchers and investment firms.

Click here to read the Reuters news article.

Michigan podiatrists skipping out on CE?

Two Michigan Podiatric Medical Association employees blew the whistle on their own organization's practices, were fired, and now have filed a lawsuit against the association. From the Lansing State Journal:

The suit against the association and seven board members alleges some podiatrists would get credits at a major annual conference without attending the lectures. Continuing education credits are required for podiatrists to renew their medical licenses.

"People would sign in and either not attend the lectures or leave and go back to their offices and work and come back at the end of the day, sign in and get full credits," said former executive director Mark Dickens said. "There were instances where the lecture never occurred, and there was no one there."

Dickens and former marketing director Meghan Webber claim the association board of directors resisted their efforts to fix the system and fired them after they filed complaints with the state.

Last week, state community health officials got the go-ahead to launch a formal investigation.

Click here to access the article.

Survey on Impact of Senate Finance Committee Report

My friends over at Medical Meetings magazine took me up on my suggestion to post an online survey on this topic. What impact do you think the recent Senate Finance Committee Report will have on the world of CME? -- click here to access this short survey and tell MM what you think (Thank you, Medical Meetings magazine!). Click here to access the Senate Finance Committee's Report.

Physicians and industry survey results

The results of a 2003-2004 survey of 3,167 physicians representing six specialties have just been published in the New England Journal of Medicine:

Most physicians (94%) reported some type of relationship with the pharmaceutical industry, and most of these relationships involved receiving food in the workplace (83%) or receiving drug samples (78%). More than one third of the respondents (35%) received reimbursement for costs associated with professional meetings or continuing medical education, and more than one quarter (28%) received payments for consulting, giving lectures, or enrolling patients in trials. Cardiologists were more than twice as likely as family practitioners to receive payments.

Click here to access the abstract.

Short sightedness?

Jerry Avorn, MD, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, gives his perspective on the Prescription Drug User Fee Act (PDUFA) in the New England Journal of Medicine:

There were problems with the user-fee approach from the beginning. The original legislation required that no portion of companies' fees (about half a million dollars per drug reviewed) could be spent to evaluate drug side effects after approval — the time when many important safety concerns become apparent. The new law mandated strict deadlines for approval decisions. To comply, the FDA reassigned staff scientists to work on new drug applications, pulling the scientists from other regulatory activities. Several were taken from the Office of Drug Safety, which conducts adverse-effects surveillance — a move that helped to shrink and demoralize that unit.

Click here to access (registration required; NEJM is offering as a free text article). Please note there are a couple of other free text articles on FDA reform in the same issue.

Senate Finance Committee issues report on educational grants from industry

Well, here it finally is -- "Use of Educational Grants by Pharmaceutical Manufacturers" -- an excerpt from the Executive Summary of this report:

Indeed, ACCME’s records reveal numerous cases over the past 3
years in which companies had too much influence over the content of supposedly independent educational programs. In one case, a CME provider was cited for allowing a company to help select presenters; in another, the company allegedly influenced the setting and frequency of educational events. One CME provider was cited for promoting the ‘‘proprietary business interests of a commercial interest’’ during an educational program. During 2005 and 2006, 18 of the 76 CME providers reviewed by ACCME—or 24 percent—did not comply with at least one of the standards meant to ensure independence.

Another continuing concern for the Committee staff is the lack of proactive or real time oversight for educational grant programs. CME providers are not required to run prepared text by the FDA, ACCME, or any regulatory authority in advance of CME programs, and the FDA and ACCME do not routinely place monitors in CME audiences to assess what information is presented. Both the FDA and ACCME have intervened after the fact when presented with evidence that abuse occurred in educational grant programs. They do not, however, pre-approve or directly monitor educational grant programs and oversight actions may occur long after the problematic educational activity occurred. Even when ACCME determines that the CME providers repeatedly failed to distance themselves from the drug companies that sponsor them, ACCME can take years to impose penalties. Based on ACCME policies, it can take as long as 9 years from the date of a non-compliant educational activity for an educational provider to lose accreditation.

Click here to access the report.

Do drug reps "play" doctors?

Interesting article over at PLoS: "Following the Script: How Drug Reps Make Friends and Influence Doctors." Click here to access the article; if you read it, let me know what you think.
:)

Public Library of Science (PLoS)

A quick post to let readers know about this peer-reviewed open-access online journal. From the PLoS website:

PLoS is a tax-exempt, 501(c)3, nonprofit corporation headquartered in San Francisco, California (Federal Tax ID 68-0492065). PLoS is governed by a Board of Directors chaired by PLoS co-founder Harold Varmus.

PLoS received a $9M start-up grant from the Gordon and Betty Moore Foundation and has received support from the Sandler Family Supporting Foundation, the Open Society Institute, the Irving A Hansen Memorial Foundation, the Doris Duke Charitable Foundation, the Ellison Medical Foundation, the Burroughs Wellcome Fund, and many other foundations, universities, and other organizations and individuals.

Click here to access this online journal.

Are we too used to seeing overweight children?

As reported in the Wall Street Journal, heart researchers at Cincinnati Children's Hospital Medical Center have "found that a number of kids viewed as normal, healthy children by their parents and even the medical staff at the hospital were later found to have enlarged hearts -- a thickening in the wall of the main pumping chamber. Even some children under 10 years old showed signs of the condition, known as left ventricular hypertrophy, or LVH." From the article:

Given the attention on childhood obesity today, how could doctors not notice that these kids were heavy? One argument is that there are so many of them.

"We've grown so accustomed to an overweight child walking into the exam room that we've lost our visual representation of what a normal child is supposed to look like," says Tom Kimball, a pediatric cardiologist at the hospital. In short, overweight is the new "normal."

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

Delivering bad news

Is there a good way to tell a mother that her daughter has died? Let's say there is a compassionate way to do so and doctors in training at Emory University School of Medicine get to practice delivering bad news in a simulation workshop:

"They might not remember your name, but they will remember exactly the phrasing you used, how you said it, if they were confused," she tells the doctors. "People can recall that event very, very vividly. People can relive that and replay that." To avoid any confusion or misunderstanding, she advises the doctors to choose their words carefully. Instead of saying "passed on" or "not going to make it," she tells them to be straightforward. "I've seen family members be confused when someone goes in to talk about the news of death and (the doctors) can't actually say the person has died."

Click here to access the CNN.com article.

Medinnovation Blog

Although the writings of Richard L. Reece, M.D. are certainly not new to me, I've just discovered he has his own blog! And, I'm very happy to report, I have his permission to link from my blog to his! (Now if only Sam Elliott will contact me, life will be complete).
:)
Click here to access Doctor Reece's blog; interesting, interesting stuff!

Freaky Friday?

This New York Times article caught my attention "Doctors Try New Surgery for Gallbladder Removal." Apparently some surgeons in New York removed a woman's gallbladder through her vagina as part of a study! Dude, count me out on that approach; if I ever need my gallbladder out I'm going with the current standard of care. Click here to access the article.

New Safety & Quality Proposal from America's Health Insurance Plans

The AHIP's Board of Directors issued a press release on its proposal "Setting A Higher Bar":

The plan calls for the development of a new entity to compare the safety and efficacy of medical procedures and technologies, advocates steps to promote transparency of health care information and speed the adoption of best practices, and calls for the creation of a new patient-centered dispute resolution mechanism.

“Improving the safety and quality of care will allow the nation to more quickly provide coverage to all Americans,” said Karen Ignagni, President and CEO of AHIP. “We can enhance the value of the nation’s investment in health care and ensure that patients receive the right care at the right time in the right setting.”

Read their proposal and let me know what you think. Click here to access the press release and the proposal.

Will the case of Ketek lead to reform?

Check out "The FDA and the Case of Ketek" written by David B. Ross, M.D., Ph.D. and just published in the New England Journal of Medicine. Click here to read this important article (registration required).

The American College of Lifestyle Medicine

First that I've heard of this organization but better late than never... From the New York Times article:

The Centers for Disease Control and Prevention reports that 1.7 million Americans die and 25 million are disabled each year by chronic diseases caused or made worse by unhealthy lifestyles. And a 2005 study in The New England Journal of Medicine predicted that average life expectancy in the United States would decline in the next 20 years as a result of unhealthy lifestyles, reversing a trend dating to the 1850s. The American College of Lifestyle Medicine has 150 members in a wide array of specialties — nutritionists, ophthalmologists, gastroenterologists and oncologists, among others. Helping their cause is a new publication, The American Journal of Lifestyle Medicine, which appears every other month with peer-reviewed research on the way daily habits affect health.

Click here to read the news article. Click here to access the college's website.

Canadian open-access medical journal goes live!

Just learned that a new open-access online medical journal has gone live. From the cta.ca news article:

Open Medicine, to be officially launched Wednesday, was conceived in the bitter aftermath of the February 2006 firing of the editor and deputy editor of the Canadian Medical Association Journal.

The publication's business model differs greatly from standard medical journals. It will be available online only, will have no subscription fees, and no corporate or medical association ownership.

Click here to access the news article. Click here to access Open Medicine.

New IT consulting company launched!

I'm delighted to announce the launch of a brand new company, The Chimera Partnership, LLC. The company was started by the husband, Samir D. Mehta, MCP, of my friend and colleague, Ann Lichti (whom many of you might know from her articles in Medical Meetings magazine).

The Chimera Partnership, LLC states that it is a full-service IT consulting company with a mission to provide clients with reliable, stable and secure IT solutions to whatever technology issues they face. Core capabilities include: Data analysis (including CME/CE outcomes data analysis and report generation); Custom applications (including CME/CE participant databases, patient registries, and clinical trial management systems); Comprehensive network security; Disaster recovery services; Project management; IT manager/staff competency analysis; and comprehensive staff training programs. Click here to access the Chimera Partnership's website.
Disclosure: I have no financial interest in this company.

FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations

Click here to access this FDA alert.

Start low and go slow...

This old adage regarding prescriptions might end up with a new meaning if a bill limiting DTC advertising is passed by Congress:

Pharmaceutical companies could be prohibited from advertising new drugs directly to consumers for the first two years they are on the market under a bill moving through Congress this week.

The goal, supporters say, is to ensure medicines are safe before allowing industry to promote them to consumers in the hopes they will request prescriptions from doctors.

But a reduction in TV and print advertising, which helped transform medications for heartburn and arthritis into blockbusters, would be a serious financial blow to drug makers. According to one study, every $1 spent on pharmaceuticals advertising often adds more than $2 in sales.

Click here to read the WTOPnews.com article. If this bill is passed, would that mean more funding for CME?

Silence is not golden...

An article in today's New York Times points out that, historically, doctors in training learn in an environment that doesn't always welcome their input. From the article:

Although some senior physicians welcomed feedback from their juniors, others disdained it, either overtly or through intimidation. And students were all too easily intimidated. In a 1993 article in The New England Journal of Medicine, a Harvard medical student reported that although her resident routinely made derisive remarks about her patients on rounds, the rest of the team laughed nervously rather than confront her.

Similarly, as Dr. Adam J. Wolfberg wrote in the same journal last month, for years medical students performed pelvic examinations on anesthetized women who had not given consent because senior obstetricians said it was the best way to learn internal anatomy. Although this practice made many students uncomfortable, most were afraid to speak up.

The good news is that things are changing in this regard. Click here to read this article.

Smart tool aids in triage of emergency room patients

Do patient-centered (or "centred" as they spell it in Canada) information systems assist in the triage of Emergency Room patients? The Scarborough Hospital, Canada's largest urban community hospital, and Canada Health Infoway have launched such a new system:

The user-friendly kiosks are available in English, but will also feature interfaces in seven different languages including English, French, Chinese (Cantonese and Mandarin), Tamil, Punjabi, Farsi, Hindi and Urdu. Patients are asked a number of questions in their native language and can choose answers from a comprehensive list. The system then translates the information into English for use by the care providers. It is estimated that approximately half of the patients at the Scarborough Hospital speak English as a second language.

It will be interesting to see how successful this system will be in the ER setting. I would love to see such a system utilized for office visits. Click here to read the news article.

Surgical infection prevention

Check out this article just published in the Archives of Surgery: "Enhancing Compliance With Medicare Guidelines for Surgical Infection Prevention: Experience With a Cross-disciplinary Quality Improvement Team." What were the measures?:

(1) percentage of patients receiving antibiotics within 1 hour of incision,
(2) percentage of patients with appropriately selected antibiotics, and
(3) percentage of patients with antibiotics discontinued within 24 hours of operation end time.

And the results:

One thousand seventy-two patients were monitored. Measure 1 compliance improved from 72.25% to 83.78% (P<.001, Cochran-Armitage trend test); improvement or high performance (>90% compliance) was demonstrated in 5 of 7 services. Measure 2 compliance remained uniformly high (approximately 98%). Measure 3 compliance improved from 54.5% to 87.16% (P<.001); improvement was seen in 5 of 7 services.

How did that do all that? They formed a multidisciplinary team comprised of "a surgeon, an anesthesiologist, nurses (preoperative, operating room, and floor), a pharmacist, a hospital infection control committee member" and quality improvement specialists. They defined the hospital guidelines for surgical infection prevention, they defined personnel roles, they standardized processes and enhanced communication/education for their health care professionals. Did their CME folks certify their improvement activity for credit? Don't know, but they could've! Click here to access the abstract.

No Free Lunch?

Most of us are familiar with the organization "No Free Lunch"; well, they've just gone live with an online searchable database so that interested patients can locate physicians who do not accept freebies from industry. Click here to access the organization's website.

CME in the theater

I subscribe to various news alerts and thought I'd share this one on Military CME. Whenever you are buried by paperwork and anytime you doubt how important CME really is, think of this conference, the Multi-National Corps-Iraq Physician Assistants Conference, “Healthcare in a Deployed Environment,” which was not only for PAs but other medical professionals:

“Bringing us together allowed us to learn about treatment procedures, emergency medical gear and new innovations that other physician assistants have developed,” said Col. William Tozier, Task Force 3 Medical Command senior physician assistant.

“The scope and severity of many of the injuries we see in theater on a daily basis are unlike those experienced at trauma centers (in the U.S.) — even very busy ones,” said Lt. Col. William Magdycz, M.D., Task Force 3 surgical consultant. “Our providers have developed a very unique expertise. Sharing their experience with other providers helps to generalize that knowledge in theater. This can only improve the timing and quality of care for our service members,” he said.

Once assigned in theater, many PAs find themselves in remote areas and without consistent communication due to limited phone and network access, Tozier said.

“This meeting allowed them to talk about topics that currently impact their practice,” Tozier said. “I expect that many will change the way they practice medicine as a result of this conference.

That is what is important — not the review of old medical information, but the creation of new information and practices as a result of what they learned here.”

Click here to read the entire article.

The beginning of the end for prescription data mining?

Looks like lawmakers are taking a close look at companies that sell physician prescribing data to pharmaceutical companies:

Data-mining companies strongly defend what they do, saying the information they provide makes marketing less wasteful, more profitable and less annoying to doctors.

New Hampshire last year became the first state to ban such use of the data.

"I would say most doctors are shocked when they hear that drug reps really know everything they've written," said New Hampshire state Rep. Cindy Rosenwald, who sponsored the legislation.

The nation's largest health data-mining company, IMS Health of Norwalk, Conn., is challenging the New Hampshire law in federal court. IMS is also fighting a 2001 ban in the Canadian province of Alberta on releasing doctors' names.

States that have considered similar bills include Arizona, Illinois, Kansas, Maine, Nevada, New York, Massachusetts, Rhode Island, Vermont, Washington, West Virginia and Texas. A federal bill was proposed last year but died in committee.

Click here to read the news article.

FDA Urgently Warns Consumers about Health Risks of Potentially Contaminated Olives

The U.S. Food and Drug Administration (FDA) is alerting consumers to possible serious health risks from eating olives that may be contaminated with a deadly bacterium, Clostridium botulinum. C. botulinum can cause botulism, a potentially fatal illness. The olives are made by Charlie Brown di Rutigliano & Figli S.r.l, of Bari, Italy and are being recalled by the manufacturer. No illnesses have been reported to date in connection with this recall.

Click here to see the full FDA Safety Alert.

DTC medical device ads

Interesting article in the Wall Street Journal on direct-to-the-consumer medical device ads. Will they become as big as the DTC pharma ads? From the article:

To be sure, ad spending on medical devices isn't likely to become quite as significant as the money poured into pharmaceutical drugs, which more than doubled to $5.3 billion last year from 2000, according to TNS Media Intelligence. The device market is worth about $50 billion in sales right now, estimates Milton Hsu, a medical-devices industry analyst for Bear Stearns, compared with $320 billion for pharmaceuticals. TNS doesn't break out spending by medical-device makers. Most TV ads for medical devices air in the so-called spot market in limited regions of the country, rather than on national networks where airtime is more costly.

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

Do physicians consider your out-of-pocket costs?

A study conducted by the Center for Studying Health System Change (HSC) and the University of Chicago Hospitals indicates that:

While almost 80 percent of physicians consider patient costs when prescribing a generic over a brand-name drug, far fewer consider patient costs when deciding what diagnostic tests to recommend (40.2%) or deciding whether to hospitalize a patient when outpatient treatment is an option (51.2%), the study found.

Click here to read the news release.

Smoking stats from the CDC

The Centers for Disease Control recently published its 2005 smoking statistics -- some highlights:

The annual prevalence of current smoking among U.S. adults declined from 24.7% in 1997 to 20.9% in 2005.

For both sexes combined, the percentage of adults who were current smokers was lower among adults aged 65 years and over (10.4%) than among adults aged 18–44 years (24.0%) and 45–64 years (21.7%). This pattern in current smoking by age group was seen in both men and women.

Non-Hispanic white adults and non-Hispanic black adults were more likely than Hispanic adults to be current smokers.

Click here to access all of the smoking data from the January-September 2006 National Health Interview Survey.

"Sick" a new book

Yes, that's the title of a new book written by Jonathan Cohn, a senior editor at The New Republic. The book is reviewed in the New York Times by Sally Satel, who is a physician and a resident scholar at the American Enterprise Institute. An excerpt from this excellent review:

“Sick” does not offer a prescription for our ailing health care system, but it does include a closing chapter on what to do. Here the argument turns tendentious. Critics of universal coverage, Cohn writes, often traffic in alarmist tales “about rationing and waiting lines, followed by a horror story from Britain or Canada.” Those complaints are “wildly exaggerated” and also unfair, he says, because the problem is not the result of universal health care but “of universal health care on the cheap.” But Cohn is himself being unfair when he sweepingly denounces “the principles of modern conservatism” for being “conspicuously short on ... comfort or hope.” In truth, there is nothing inherently pessimistic in choice, self-reliance or limited bureaucracy — the values that underlie a market-based proposal like the one introduced by Senator Ron Wyden, an Oregon Democrat. In this plan, employers would no longer provide insurance and would instead convert those costs into a bigger paycheck, enabling workers to buy private insurance from providers who would then be forced to compete for business by offering better plans. (Wyden’s proposal also offers subsidies for the unemployed.)

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

Hatfield-McCoy Feud possibly explained?

Just couldn't pass up posting this news item! Seems the McCoy clan might have an underlying genetic predisposition to having, well, a poor disposition:

No one blames the whole feud on the disease, but doctors say it could help explain some of the clan's behaviour.

"This condition can certainly make anybody short-tempered and, if they are prone because of their personality, it can add fuel to the fire," said Dr Revi Mathew, a Vanderbilt University endocrinologist treating a McCoy.

Von Hippel-Lindau disease can cause tumours in the eyes, ears, pancreas, kidney, brain and spine.

Roughly three-quarters of the affected McCoys have tumours of the adrenal gland.

Click here to read the Daily Telegraph article.

Reduction in Childhood Pneumonia Cases

From the Medical News Today article:

Since the introduction of the PCV7 pneumococcal conjugate vaccine, which began in 2000 in the USA, there has been a significant fall in the number of hospital admissions for pneumonia, according to a new report by researchers from Vanderbilt University School of Medicine, Nashville, USA.

Click here to read the entire article.

Pet food recall

A quick post to share this resource with y'all who have pets and are concerned about the pet food recalls (which seem to be mounting every day). Click here to access the FDA's website for the latest information.

Fourth Annual HealthGrades Patient Safety in American Hospitals Study

From the Washington Post article on this study:

The excess cost to Medicare associated with patient safety incidents was $8.6 billion from 2003 to 2005.Ten of 16 types of patient-safety incidents increased over the three years of the study, by an average of almost 12 percent. The greatest increases were in post-operative sepsis (about 34.3 percent); post-operative respiratory failure (18.7 percent); and selected infections due to medical care (about 12.2 percent).

Click here to access the WP article.

CMS releases 2007 Physician Quality Reporting Initiative Measures

There are 74 measures in the initiative, a fair amount of them relate to diabetes, antibiotic prescription, perioperative care, stroke, osteoporosis, CAP, and GERD. A few from the list:

20. Perioperative Care: Timing of Antibiotic Prophylaxis - Ordering Physician
Description
Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic parenteral antibiotics, who have an order for prophylactic antibiotic to be given within one hour (if fluoroquinolone or vancomycin, two hours) prior to the surgical incision (or start of procedure when no incision is required)
21. Perioperative Care: Selection of Prophylactic Antibiotic - First OR Second Generation Cephalosporin
Description
Percentage of surgical patients aged 18 years and older undergoing procedures with the indications for a first OR second generation cephalosporin prophylactic antibiotic, who had an order for cefazolin OR cefuroxime for antimicrobial prophylaxis
22. Perioperative Care: Discontinuation of Prophylactic Antibiotics (Non-Cardiac Procedures)
Description
Percentage of non-cardiac surgical patients aged 18 years and older undergoing procedures with the indications for prophylactic antibiotics AND who received a prophylactic antibiotic, who have an order for discontinuation of prophylactic antibiotics within 24 hours of surgical end time
23. Perioperative Care: Venous Thromboembolism (VTE) Prophylaxis (When Indicated in ALL Patients)
Description
Percentage of patients aged 18 years and older undergoing procedures for which VTE prophylaxis is indicated in all patients, who had an order for Low Molecular Weight Heparin (LMWH), Low-Dose Unfractionated Heparin (LDUH), adjusted-dose warfarin, fondaparinux or mechanical prophylaxis to be given within 24 hours prior to incision time or within 24 hours after surgery end time

Click here to access the CMS release; click here to access the list of 74 measures. What percent of your CME Program will address these measures? Will you be able to link your CME activities to these measures in your CME database?

No more free CME dinners at the local steak house?

Check out the March 2007 Medical Meetings article "Stark II Update" authored by Sue Pelletier. Sue relates that the AMA wrote a letter to CMS asking that CMS make an exemption "'that permits physician compensation without financial limit in the form of continuing medical education that is offered for the purpose of ensuring quality patient care.'" And how did CMS respond?:

In a letter the AMA received in March of last year, Mark McClellan, administrator, Centers for Medicare and Medicaid Services, said, “After careful review, we do not think that a broad exception is consistent with our statutory mandate to create by regulation only those exceptions that pose no risk of program or patient abuse. In our view, CME provided at no or reduced cost — particularly CME off-site from the hospital — may pose a risk of program abuse.” The good news, however, is that CMS did agree that traditional on-site hospital CME programs, such as grand rounds and tumor boards, don't constitute remuneration to physicians and so should not fall under Stark II rules, Aparicio said.

Click here to read the entire article. CMS should be out with a final rule sometime very soon.

Alliance announces new executive director

From an announcement from the Alliance President, Sue Ann Capizzi, MBA:

On behalf of the Board of Directors of the Alliance for CME, it is my pleasure to announce that Paul D. Weber has been named the new Executive Director of the Alliance for CME effective April 27, 2007. Mr. Weber is the fourth Executive Director in the Alliance's thirty-two year history.

Click here to access the full announcement. Congrats to Mr. Weber!

Both sides now?

Interesting article in USA Today on unapproved drugs and the terminally ill:

Frustrated with the cumbersome process for obtaining experimental drugs — which requires dealing with the FDA bureaucracy as well as drugmakers and research institutions — a patient advocacy group has taken the FDA to court. The group argues that mentally competent terminally ill patients have a right to get such drugs.

Howard Fine, chief of the brain cancer branch at the National Cancer Institute, says he understands both sides of the debate over experimental drugs.

"Ethically speaking," Fine says, noting that he's talking only for himself, "who has the right to say to a patient: You have no right to try this medicine even though you're dying, even though you're well informed?"

On the other hand, he says, giving unapproved drugs to anyone who wants them would be a logistical nightmare: "Where are (drugmakers) going to send these drugs? The local doc down the street? And who's going to educate the doctor?"

Click here to read the entire article.

Why physicians leave a practice...

In a nutsell, it's the ole "not-a-good-fit" reason. According to a survey conducted by Cejka Search and published in STLToday:

More than half of the practices surveyed said "poor cultural fit" was No. 1 among the top three reasons given by departing doctors before they left. Cultural fit could include differences in clinical approach, bedside manner or management style. The other two top reasons for leaving were relocating closer to family and seeking higher compensation.
...
Statistically, most doctors leave a practice between years one and three.
...
Turnover rates were about the same among men and women. Among female physicians, however, the rates declined by about a percentage point versus the previous year. The rates among male physicians rose by about a point.

Click here to read the entire article.

FDA Announces Voluntary Withdrawal of Pergolide Products

From the 3/29/07 FDA release:

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

Click here to read the entire release.

Ask Dr Wiki?

Discovered an interesting website -- Dr Wiki -- which "is a collaborative medical website made by physicians for physicians, medical students, and healthcare providers. Its purpose is to serve as a online repository of medical information that can be accessed by anyone." The site's current editors are:

Kenny Civello M.D., M.P.H, Cleveland Clinic Electrophysiology
Brian Jefferson M.D, Cleveland Clinic Interventional Cardiology
Shane Bailey M.D., Cleveland Clinic Electrophysiology
Mike McWilliams M.D., Cleveland Clinic Electrophysiology

The site is pretty cardiology "heavy" but Dr Wiki hopes the site will expand to encompass many more specialties. Click here to access the site.

To stent or not to stent...

Will patients and interventional cardiologists both be slow to embrace the new evidence on the value of drug therapy versus angioplasty? As reported in the Philadelphia Inquirer:

Studies have long shown that angioplasty can save a patient who is having a heart attack.

But the study released online Monday in the New England Journal of Medicine showed that patients who are not likely to have an immediate heart attack fared just as well with drug therapy.

The study found that more than half the patients who get angioplasties - more than a million each year - have heart disease that is stable and would do just as well under medication. The authors said the proportion of unnecessary angioplasties is as high as 85 percent - at a cost of about $30,000 to $40,000 per patient.

David L. Fischman, an interventional cardiologist and codirector of the cardiac-catheterization lab at Thomas Jefferson University Hospital, said patients and doctors should view angioplasty as a quality-of-life decision. The study found that half the 2,287 patients who received a stent had fewer symptoms, such as angina, at the onset. Those numbers narrowed as the study went on.

It will be interesting to see how the payors respond to these findings. Click here to read the entire article.

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.

FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.

Click here to read the entire FDA release.

Joint Commission says health literacy a patient safety issue

From the USA Today article:

While cultural and language barriers pose problems for patient-doctor communication, poor general literacy skills can be just as great an impediment, according to The Joint Commission, which accredits nearly 15,000 U.S. health care organizations and programs.

"The implications around all of this are huge if the patient doesn't understand what they have and what they're taking and why. You might be putting the patient in harm's way, and they could be killed," says Dennis O'Leary, president of the commission.

The commission held a news conference in February to present recommendations for health care providers, policymakers and consumers.

The recommendations include specific advice for educating and training health care professionals; using well-trained medical interpreters for patients with English comprehension difficulties; and encouraging a culture of easy-to-understand communication in all facets of medical care.

Click here to read the entire article. Click here to access the Joint Commission's guide "'What Did the Doctor Say?:' Improving Health Literacy to Protect Patient Safety".

FDA proposes revamp of conflict of interest rules

As reported in the LA Times:

The Food and Drug Administration said Wednesday that it would bar outside medical experts with a financial interest in a manufacturer from voting on advisory panels assessing whether drugs or other products made by that company are safe and effective.

The proposed restrictions — which would also apply to experts with ties to competing firms — would significantly strengthen the FDA's conflict-of-interest policy. One recent study suggests that more than one-fourth of FDA advisors may be prohibited from voting.

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

Joint Commission Annual Report

Check out the annual report recently released by the Joint Commission. While things seem to be on the upswing, looks like there's still room for improvement in hospital quality of care:

Hospitals are currently achieving a national average of 90 percent performance or higher on only about half of the measures tracked since 2002. Hospitals are performing at less than 65 percent nationwide on two measures tracked since 2002: providing pneumococcal screening and vaccination to pneumonia patients, and providing discharge instructions to heart failure patients. The Joint Commission encourages all hospitals to strive for 100 percent performance on all measures.

On measures tracked for the first time in 2005, performance is generally lower and more variable than on the performance for measures tracked since 2002, showing a correlation between performance measurement and quality.

Significant differences exist in the performance of hospitals by state. For example, the performance of hospitals in different states on the measure of providing smoking cessation advice to heart attack patients ranged from a high of 96.8 percent performance in the highest-performing state to a low of 67.6 percent in the lowest-performing state.

CME Providers in health care delivery institutions, check out your hospital's quality performance at qualitycheck.org.

Collateral fire damage

Fascinating epi study published in the New England Journal of Medicine on firefighters and death from heart disease in the United States. One of the study findings:

Fire suppression, which represents only about 1 to 5% of firefighters' professional time each year, accounted for 32% of deaths from coronary heart disease and was associated with a risk of death from coronary heart disease that was approximately 10 to 100 times as high as the risk associated with nonemergency duties. We think that the most likely explanation for these findings is the increased cardiovascular demand of fire suppression.

Click here to read the entire free article.

Two new books by physician-writers

Health care professionals (e.g., CME professionals) might be interested in two new books authored by physicians. They are "Better: A Surgeon's Notes on Performance" by Atul Gawande and "How Doctors Think" by Jerome Groopman. From the Washington Post article:

The authors' hopes for medical practice based on greater self-scrutiny will be a tall task as well. We live in an era of evidence-based medicine, in which population-based studies, Bayesian analysis and clinical guidelines increasingly dictate medical care. Both authors bemoan this development insofar as it makes physicians into technicians. Doctors, Gawande writes, need to stop to "wonder" and reconsider the paths they have taken. Groopman's best physicians arrive at judgments by assessing not only their patients' complaints but their characters and by paying attention to their own emotional responses to patients.

Reflection is a good thing and part of the improvement process. Click here to read the entire article.

And the results are in...

JAMA just published an article on the early results of the Vermont and Minnesota laws requiring pharmaceutical companies to disclose payments to physicians:

In Vermont, 61% of payments were not released to the public because pharmaceutical companies designated them as trade secrets and 75% of publicly disclosed payments were missing information necessary to identify the recipient. In Minnesota, 25% of companies reported in each of the 3 years.

Click here to read the article (subscription required).

Following doctor's orders...NOT!

A recent survey by the Wall Street Journal and Harris Interactive reveals that 27% of Americans who responded do NOT fill a precription because they don't feel it is warranted. More from this interesting survey:

About 52% of Americans believe doctors overtreat patients because of concerns about malpractice lawsuits, while 41% say doctors do so "to make more money" and 44% say "to meet patients' demands."

Still, Americans seem to believe that undertreatment is a problem, too. When asked how often they believe patients are undertreated, 29% said often and 55% said sometimes.

Click here to read the WSJ article (subscription required).
:)

Errors in diagnosis

According to Dr. Jerome Groopman, misdiagnosis occurs in 15 to 20 percent of cases. Why? Because of how doctors think:

Only very recently have medical educators begun to focus squarely on the problem of misdiagnosis, why it occurs, and what might be done to prevent it. It turns out that errors in thinking do not occur in isolation, but usually arise from a cascade of sequential cognitive mistakes.

I only learned this recently when I realized I did not know how I think; in fact, when I asked other clinicians how they succeeded or failed in making a diagnosis, very few could explain how their mind works to decipher a patient's problems.

Click here to read the Boston Globe article. What implications do you think this might have for CME?

A piece of Dr. Reece's mind

Great essay by Richard Reece, M.D. published today in HealthLeaders Media. Doctor Reece discusses the complex issues that arise with pay for performance (P4P). He presents, methinks, very valid questions and truths relative to this whole issue of P4P, an excerpt:

Compelling doctors to follow guidelines and enforcing their compliance is not as easy as it might seem. Whose guidelines? Keep in mind there are more than 2,000 guidelines floating around out there. You may find them at the National Guideline Clearinghouse website (www.guideline.gov). These guidelines depend on both evidence and opinion and are neither infallible nor a substitute for clinical judgment.

Doctors are mortal and may have a hard time keeping all these guidelines in mind. Small wonder that adherence to guidelines and outcomes vary. As I outline above, patient behavior outside of the office and hospital settings is an important factor in healthcare outcomes. Doctors can’t be held solely--or even primarily--responsible for outcomes, and rewarding or punishing them for outcomes may be overly simplistic. Doing so in the confined hospital setting may make P4P advocates “feel good,” and it is a good place to start, but P4P may not lead to better long-term outcomes.

We all know those people who won't quit smoking, who won't exercise, etc., even after they've endured life-saving procedures. Click here to read this important essay (you have register).

ACCME news release

The Accreditation Council for Continuing Medical Education (ACCME) is implementing a new system to recognize non-U.S. CME accreditors:

At the ACCME, "Recognition of non-US continuing medical education accreditors" will be based on substantial equivalency of accreditors. Our engineering colleagues[1] state that "substantial equivalency means the program is comparable in educational outcomes, but may differ in format or method of delivery" and that "substantial equivalency is not accreditation."

And the question that comes to everyone's mind is "will they have to comply with the ACCME Standards for Commercial Support of CME"? Click here to read the news release in its entirety.

New label warnings for sleep disorder medications

The FDA has ordered manufacturers of 13 drugs used to either treat sleep disorders or used as sleep aids to revise their "product labeling to include warnings about the following potential adverse events":

Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken.
Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep).

The 13 drugs are:

Ambien/Ambien CR (Sanofi Aventis)
Butisol Sodium (Medpointe Pharm HLC)
Carbrital (Parke-Davis)
Dalmane (Valeant Pharm)
Doral (Questcor Pharms)
Halcion (Pharmacia & Upjohn)
Lunesta (Sepracor)
Placidyl (Abbott)
Prosom (Abbott)
Restoril (Tyco Healthcare)
Rozerem (Takeda)
Seconal (Lilly)
Sonata (King Pharmaceuticals)

Click here to see the FDA news release.

"Questions Are the Answer"

The Agency for HealthCare Research and Quality has launched a new national public awareness campaign to encourage patients to become more proactive and assertive in their medical care. The idea is that if patients ask the right questions at the right time, then medical errors might be reduced. Here are a few of the questions they suggest asking:

What is the test for?
How many times have you done this?
When will I get the results?
Why do I need this surgery?
Are there any alternatives to surgery?
What are the possible complications?
Which hospital is best for my needs?
How do you spell the name of that drug?
Are there any side effects?
Will this medicine interact with medicines that I'm already taking?

Honestly, I can't get my Mom to ask any questions of her health care provider, much less these. Click here to access the general website; click here to access "20 Tips to Prevent Medical Errors."

FDA black box warning on anemia drugs

The FDA issued an advisory today on erythropoiesis-stimulating agents (ESAs) which are "approved to treat anemia in patients with chronic kidney failure, and in cancer patients whose anemia is caused by chemotherapy." From the SCIENTIFICAMERICAN.COM article:

"Recent reports of studies with erythropoiesis-stimulating agents (ESAs) have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents," an FDA public health advisory said.

"Because all ESAs work the same way, the findings from these studies apply to all ESAs; the FDA is re-evaluating the safe use of this drug class," the advisory said.

The FDA will gather further input from a May meeting of a panel of outside experts. More changes to the drugs' labels could follow that meeting, FDA officials said.

Click here to read the entire article. CME Providers might want to review their enduring material lists!

16 Rules to live by

Thanks to Sue Pelletier, MeetingsNet Web editor, mad blogger (Face2Face), and editor of Association Meetings Magazine for including the link to Bob Parson's 16 rules to live by in her blog. The 16 rules:

1. Get and stay out of your comfort zone.
2. Never give up.
3. When you're ready to quit, you're closer than you think.
4. With regard to whatever worries you, not only accept the worst thing that could happen, but make it a point to quantify what the worst thing could be.
5. Focus on what you want to have happen.
6. Take things a day at a time.
7. Always be moving forward. Never stop investing. Never stop improving. Never stop doing something new.
8. Be quick to decide.
9. Measure everything of significance.
10. Anything that is not managed will deteriorate.
11. Pay attention to your competitors, but pay more attention to what you're doing.
12. Never let anybody push you around.
13. Never expect life to be fair.
14. Solve your own problems.
15. Don't take yourself too seriously.
16. There's always a reason to smile.

The above rules are displayed here with the permission of Bob Parsons (http://www.bobparsons.com). Copyright © 2004-2006 by Bob Parsons. All rights reserved.

Gosh, could these be applied to CME?
:)

ACCME posts clarification on expanded definition

Click here to read this clarification.

Retention of foreign object...

is one of 27 categories of medical errors that the Indiana Medical Error Reporting System utilizes. From the INDYSTAR.COM article:

State health officials said the error-reporting system is designed to give health-care providers useful information in understanding why errors occur and developing systems for preventing future errors. The officials also said they expect the number of reported errors to rise as hospitals become familiar with the program.

“Every health care provider takes adverse events seriously; even one adverse event is too many,” Kathy Rapala, interim director of the Indianapolis Coalition for Patient Safety, said in a statement. “The statewide report provides valuable information that we can use to guide our patient safety actions.”

Gov. Mitch Daniels ordered the Indiana Department of Health to begin collecting the information in 2005. But the preliminary report released today is the first comprehensive look at a full year.

Click here to read the entire article.

Congressional committee to look at off-label use issues

As reported today in the Wall Street Journal, a congressional committee will examine "the widespread practice in which doctors prescribe medical products to patients outside the boundaries approved by the Food and Drug Administration." Boston Scientific Corp. and Johnson & Johnson's Cordis unit, have been asked to provide clinical data and marketing materials on their drug-coated stent products to the House Committee on Oversight and Government Reform. In addition:

The committee's chairman, California Democrat Henry Waxman, also asked for marketing materials from three drug companies that have come under scrutiny over whether they promoted their products for unapproved uses: Eli Lilly & Co., whose antipsychotic drug Zyprexa had $4.36 billion in sales last year and was the company's best seller; AstraZeneca PLC, which makes another depression drug, Seroquel; and Cephalon Inc., whose marketing of painkillers has been under investigation by the Connecticut attorney general.

Click here to read the article (subscription required).

The Boardman Incident

When Dr. Cecelia Boardman, a gynecologic oncologist at Virginia Commonwealth University's Massey Cancer Center, made statements before the Viginia General Assembly regarding the efficacy of the new Merck vaccine to prevent HPV infection, she apparently failed to disclose her financial relationship with Merck (per the newspaper article, she has given "educational talks" to physicians on the new vaccine). While she "didn't violate any disclosure requirement governing witnesses who give input to lawmaking committees" and no one, apparently, questions her credentials, she still ends up in the headlines. From the article:

"I'm most distressed and most apologetic and most concerned that there is any perception of my being dishonest or untruthful," Boardman said. "I have done a lot of public speaking on cervical cancer and cervical cancer prevention in my professional roles. In my mind, I did not feel any conflict in the testimony I provided."

She said she did not participate in Gardasil research and that she independently evaluated the drug's performance before coming to her conclusion that it works.

"If I thought the data was crummy, I'd say the data was crummy," she said.

Click here to read the entire article. I'd like to know if these "educational talks" were promotional or CME-certified presentations, one can never really tell from these news articles.

8 Pharma companies receive FDA Warning Letters

The FDA issued Warning Letters to eight (8) pharmaceutical companies regarding the unapproved use of drugs containing ergotamine tartrate for headache relief. From the ScientificAmerican.com article:

Like other approved products for migraine and other headaches, the drugs contain the active ingredient ergotamine tartrate. But they have been manufactured and distributed without undergoing review by the FDA, the agency said.

"Doctors and patients often do not realize that not all drugs that are available on the market are backed by FDA approval," said FDA's Deborah Autor, who oversees compliance issues. She added that fewer than 2 percent of prescription medications are unapproved.

"Drugs that skirt the approval process may be unsafe, may not work, and in our experience, often have inadequate labeling," she said in a statement.

The unapproved ergotamine tartrate drugs do not carry necessary cautions against their use in patients also taking the metabolic enzyme inhibitor CYP 3A4 found on labels for similar approved headache drugs, the FDA said.

Such inhibitors can include certain antibiotics, antifungal treatments and protease inhibitors.

Click here to read the article. Click here to access the FDA Warning Letters.

Serotonin Syndrome

Remember the case of Libby Zion? If you don't, then be certain to read "A Mix of Medicines That Can Be Lethal" published in the New York Times. From the article:

In March 2005, two such specialists, Dr. Edward W. Boyer and Dr. Michael Shannon of Children’s Hospital Boston, noted that more than 85 percent of doctors were “unaware of the serotonin syndrome as a clinical diagnosis.”

In their review in The New England Journal of Medicine, Dr. Boyer and Dr. Shannon cited a report based on calls to poison control centers around the country in 2002 showing 7,349 cases of serotonin toxicity and 93 deaths. (In 2005, the last year for which statistics are available, 118 deaths were reported.)

The experts fear that failure to recognize serotonin syndrome in its mild or early stages can result in improper treatment and an abrupt worsening of the condition, leading to severe illness or death. Even more important, in hopes of preventing it, they want doctors — and patients — to know just what drugs and drug combinations can cause serotonin poisoning.

Click here to access the article.

Prescription drug abuse

In a related International Narcotics Control Board press release on prescription drug abuse:

The demand for these drugs is so high, that it has given rise to a new problem – that of counterfeit products. Strong demand on the illicit markets of Scandinavia for flunitrazepam (Rohypnol®), a sedative, is increasingly met by illicitly manufactured counterfeit preparations. The demand of the illicit market in North America for OxyContin® has lead to distribution of counterfeit products containing illicitly manufactured fentanyl.

An equally serious consequence is that abuse of prescription drugs can have lethal effects. An increasing number of deaths related to abuse of narcotic drugs, including fentanyl and oxycodone have been recorded in North America and Europe.

Click here to read this press release (fyi, they have 2006 on the 1st page...should read March 1, 2007).

Counterfeit drugs a real issue!

The International Narcotics Control Board (INCB) issued a press release today on the dangers of counterfeit drugs:

“Besides the fact that the existence of unregulated markets, the sale of diverted and counterfeit drugs and the purchase of drugs containing controlled substances without prescription contravenes international treaties on drug control, it is important for consumers to realize that what they think is a cut-price medication bought on an unregulated market may however have potentially lethal effects whenever the consumed drugs are not the genuine product or are taken without medical advice. Instead of healing, they can take lives,” said Dr. Philip O. Emafo, President, INCB.

Click here to read the press release.