Orthopedic companies to pay $311 million

From the Wall Street Journal article:

Four makers of orthopedic devices have entered deferred-prosecution agreements and agreed to pay a total of $311 million to settle criminal and civil probes into allegations they paid kickbacks to surgeons to use their products, prosecutors said.

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

New AACVPR/ACC/AHA Guidelines

From the Washington Post article:

Experts in cardiac care have issued new "performance measures" meant to boost patient enrollment in cardiac rehabilitation programs.

They say too many heart attack patients aren't getting the benefit of this form of care.

Click here to access the article.

International Severe Adverse Events Consortium

From the Boston Globe article:

A rare collaboration of top pharmaceutical companies, regulators and university researchers has begun attacking one of the toughest problems in medicine: why severe drug side effects strike a small percentage of patients.

Click here to access the article.

Medtronic on the hot seat!

From the New York Times article:

Medtronic, which reached a $40 million settlement last year with the federal government over accusations that the company had paid illegal kickbacks to doctors for using its spinal devices, has continued to pay doctors millions of dollars in consulting fees, according to a lawyer representing a whistle-blower involved in the case.

Senator Charles E. Grassley, Republican of Iowa, has written to Medtronic, asking the company to explain, among other things, any payments made since the period covered by the settlement. The letter is part of a broad inquiry by Mr. Grassley into the financial ties that often exist between doctors and the companies that make medical devices and drugs.

Medtronic defended the continuing payments as legitimate compensation for work the doctors have done. Medtronic said it welcomed the opportunity to speak with Mr. Grassley and his staff.

Click here to read the entire article (reg. req.).

Survey shows heath care is a ministry priority in the U.S.

From the news release:

A groundbreaking survey of more than 6,000 American congregations reveals that churches spend a significant amount of time, energy and money in the ministries of health care.

The Congregational Health Ministry Survey, conducted by the National Council of Churches USA (NCC) with support from the Robert Wood Johnson Foundation, shows that a majority of churches are serving their communities by providing health care ministries. As the number of uninsured Americans reaches 47 million people, congregations are supplying health education and direct health care services. Many are advocating on behalf of public policy issues related to health care.

Click here to access.

Tink and Henry

If you'd like to learn more about Henry, click here.

New dress code for UK physicians

From the Associated Press:

British hospitals are banning neckties, long sleeves and jewelry for doctors — and their traditional white coats — in an effort to stop the spread of deadly hospital-borne infections, according to new rules published Monday.

Hospital dress codes typically urge doctors to look professional, which, for male practitioners, has usually meant wearing a tie. But as concern over hospital-borne infections has intensified, doctors are taking a closer look at their clothing.

Click here to access the article.

The next surgical evolution?

From the Archives of Surgery article "Surgery Without Scars: Report of Transluminal Cholecystectomy in a Human Being":

Hypothesis Natural orifice transluminal endoscopic surgery (NOTES) provides the potential for performance of incisionless operations. This would break the physical barrier between bodily trauma and surgery, representing an epical revolution in surgery. Our group at IRCAD-EITS (Institut de Recherche contre les Cancers de l’Appareil Digestif [Institute of Digestive Cancer Research]–European Institute of TeleSurgery) has been actively involved in the development of NOTES since 2004 with a dedicated project created to develop feasibility and survival studies and new endoscopic technology.

Design NOTES cholecystectomy in a woman via a transvaginal approach.

Setting University hospital.

Patient The patient was a 30-year-old woman with symptomatic cholelithiasis.

Intervention The procedure was carried out by a multidisciplinary team using a standard double-channel flexible videogastroscope and standard endoscopic instruments. The placement of a 2-mm needle port, mandatory to insufflate carbon dioxide and to monitor the pneumoperitoneum, was helpful for further retraction of the gallbladder. At no stage of the procedure was there need for laparoscopic assistance. All of the principles of cholecystectomy were strictly adhered to.

Results The postoperative course was uneventful. The patient had no postoperative pain and no scars, and was discharged on the second postoperative day.

Conclusions Transluminal surgery is feasible and safe. NOTES, a radical shift in the practice and philosophy of interventional treatment, is becoming established and is enormously advantageous to the patient. With its invisible mending and tremendous potential, NOTES might be the next surgical evolution.

Click here to access the article (sub. req.). I think that if I needed my gallbladder out I'd still go laparoscopic.

'Bout time!

I remember when my stepfather had to be returned to the OR after heart surgery and I was surprised when he was charged for the additional OR time, etc. (hey, I was naive then). From the Boston Globe article:

About half of Massachusetts hospitals say they have adopted policies to waive charges for serious medical errors such as wrong-site surgery and harmful medication mistakes, and others say they plan to, amid growing resistance from government and health insurers to paying for poor outcomes.

Thirty-three of 61 hospitals recently reported to a national hospital-quality organization, The Leapfrog Group, that they have voluntarily stopped charging for 28 serious and rare errors, called "never events." But consumer groups, health insurers, legislators, and employers are pushing for more far-reaching and mandatory policies as ways to reduce errors, and hospital executives said they expect to forgo payments in an increasing number of cases, including those in which patients require additional treatment because they contracted an infection in the hospital or fell in their room.

Click here to access the article.

Jessica...

She must be a metaphor for something:

Click here to view the video.

Prescription drug labels

From the Archives of Internal Medicine article, "The Variability and Quality of Medication Container Labels":

Results We evaluated 85 labels after excluding 11 ibuprofen prescriptions that were filled with over-the-counter containers that lacked labels printed at the pharmacy. The pharmacy name or logo was the most prominent item on 71 (84%) of the labels, with a mean font size of 13.6 point. Font sizes were smaller for medication instructions (9.3 point), medication name (8.9 point), and warning and instruction stickers (6.5 point). Color, boldfacing, and highlighting were most often used to identify the pharmacy and items most useful to pharmacists. While the content of the main label was generally consistent, there was substantial variability in the content of instruction and warning stickers from different pharmacies, and independent pharmacies were less likely to use such stickers (P < .001). None of the ibuprofen containers were delivered with Food and Drug Administration–approved medication guides, as required by law.

Conclusions The format of most container labels emphasizes pharmacy characteristics and items frequently used by pharmacists rather than use instructions or medication warnings. The content of warning and instruction stickers is highly variable depending on the pharmacy selected.

Click here to access the article (free full text).

Gee, do you think they'll look at any CME activities?

From the Wall Street Journal article:

Drug maker Cephalon Inc. sent letters to doctors this week warning them that several deaths have been linked to Fentora, its powerful narcotic to treat acute cancer pain.

Fentora and its predecessor, Actiq, are approved by the Food and Drug Administration only for use in cancer patients, but they are often prescribed by physicians "off-label" for such ailments as headaches and back pain.

Cephalon denies marketing the two drugs outside their indication, but its marketing practices are under scrutiny in three separate probes: investigations by the U.S. attorney in Philadelphia and the Connecticut attorney general, and a congressional probe into off-label treatments.

Click here to access (sub. req.).

Latest FDA news on anemia drugs

From the Wall Street Journal article:

A Food and Drug Administration advisory committee stopped short of supporting a clear-cut new limit on kidney-failure patients' use of the blockbuster anemia drugs made by Amgen Inc. and Johnson & Johnson, but members split over what doses of the medications are appropriate.

Click here to access (sub. req.).

PDA and brain-injured veterans

From the News Observer article:

Troops who lose limbs in Iraq are fitted with sophisticated replacements such as computer-controlled legs. Now, some of the thousands who have returned with brain injuries are getting a prosthetic for the mind -- a personal digital assistant that serves as their short-term memory.

"If I couldn't use it, I basically wouldn't be able to function," said Master Sgt. Tony Wisyanski, an 82nd Airborne Division paratrooper based at Fort Bragg.

Wisyanski suffered a brain injury and other wounds Oct. 1, 2006, in Iraq when his Humvee was struck by two rocket-propelled grenades. While he was being treated at a brain-injury center in Virginia, a speech pathologist ordered a PDA for him. Among other things, he programs it to beep an audio alert to remind him about appointments and to record phone numbers.

You'd think at least one of these companies would step up and donate PDAs to these veterans. Click here to access the article.

Hospitalist trends...are you in the know?

From the Washington Post article:

Most hospitalists are internists; 11 percent are pediatricians. By 2010, SHM projects 30,000 hospitalists will be practicing. Medical students may soon choose which side of the hospital divide they want to work on: inpatient or outpatient. For now, it's your physician's choice whether to refer you to a hospitalist or to follow your inpatient care. If you have no primary care physician, a hospitalist will probably manage your hospital stay.

Although patients are often confused about the role of hospitalists, hospitals embrace the new model, nationally subsidizing $50,000 to $60,000 of the average hospitalist's $169,000 salary. Managed-care organizations, such as Kaiser, have established their own hospitalist practices. There is financial incentive to do so: Studies show hospitalists manage care more efficiently and reduce hospital stays. Hospitalists say they think that's because they order tests and procedures more promptly.

Shortening hospital stays is to the patient's advantage as well, said Frederick Finelli, chairman of the D.C. Board of Medicine.

Click here to access the article.

Sharp rise in adverse drug reactions

From the Wall Street Journal article:

The number of serious drug side effects and deaths reported to the U.S. Food and Drug Administration more than doubled over an eight-year period, according to an analysis of adverse-drug events reported to the agency.

As part of the agency's so-called MedWatch reporting system, drug companies, health-care professionals and the public can file reports when they think a drug is connected to a side-effect or fatality. Drug companies are required to file such reports while they are voluntary for health-care professionals.

A study, published in Monday's Archives of Internal Medicine, looked at reports that are considered serious from 1998 to 2005. The study was conducted by researchers at the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and Wake-Forest University School of Medicine in Winston-Salem, N.C.

Click here to access (subscription required).

Federal law for disclosure of gifts/payments to physicians?

From the New York Times article:

Makers of drugs and medical devices would be required to report publicly nearly all payments and gifts to doctors under legislation introduced Thursday in the Senate.

“Right now, the public has no way to know whether a doctor’s been given money that might affect prescribing habits,” said Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee and one of the bill’s authors.

Senator Herb Kohl, Democrat of Wisconsin, said drug and medical device makers had long defended their payments and gifts to doctors as appropriate.

“If that is the case, full disclosure will only serve to prove them right,” Mr. Kohl said.

Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, said, “A new law is not necessary when pharmaceutical marketing is already heavily regulated by the Food and Drug Administration.”

The F.D.A. does not regulate the gifts or consulting arrangements drug and device makers routinely provide doctors, and it reviews only a fraction of the scripted marketing talks doctors make on companies’ behalf.

Click here to read the entire article.

Interesting stuff over at the Carlat Psychiatry Blog!

Click here to read the 9/04/07 entry. Be certain to read the comment posted by James M. La Rossa Jr.

Need for CME on Biostats?

From the Science Daily article:

Donna M. Windish, M.D., M.P.H., of the Yale University School of Medicine, New Haven, Conn., and colleagues conducted a multiprogram assessment of residents' biostatistics knowledge and interpretation of research results. The study consisted of a cross-sectional survey of 277 internal medicine residents in 11 residency programs. The survey included a biostatistics/study design multiple-choice knowledge test.

...

"If physicians cannot detect appropriate statistical analyses and accurately understand their results, the risk of incorrect interpretation may lead to erroneous applications of clinical research. Educators should re-evaluate how this information is taught and reinforced in order to adequately prepare trainees for lifelong learning, and further research should examine the effectiveness of specific educational interventions."

Click here to access the article.

Teen smoking

From the Archives of Pediatric & Adolescent Medicine:

Exposure to Smoking Depictions in Movies

Its Association With Established Adolescent Smoking

James D. Sargent, MD; Mike Stoolmiller, PhD; Keilah A. Worth, PhD; Sonya Dal Cin, PhD; Thomas A. Wills, PhD; Frederick X. Gibbons, PhD; Meg Gerrard, PhD; Susanne Tanski, MD

Arch Pediatr Adolesc Med. 2007;161:849-856.

Objective To assess the association between exposure to movie smoking and established adolescent smoking.
...
Conclusion In this national US adolescent sample, exposure to smoking in movies predicted risk of becoming an established smoker, an outcome linked with adult dependent smoking and its associated morbidity and mortality.

Click here to read the entire abstract.

JAMA Medical Education Theme Issue

There are a number of interesting articles in the latest issue of JAMA. Click here to access.

A parachute story

Please read today's entry on Medinnovation.blog: "Know Who is Packing Your Parachute"

The "Swiss cheese effect"

From the HeraldTribune.com article:

Two major advances that have improved health care -- abundant, specialized medications and powerful new technology -- also create new possibility for errors.

"The likelihood of error goes up with the more steps there are," said Frances Griffin, a director of the Institute for Healthcare Improvement.

The nonprofit group, known as IHI, won acclaim for its "100,000 Lives Campaign" in 2005 to reduce medical errors.

To all that, add in that doctors are susceptible to the same "classic human factors," Griffin said: "If we have to rely on memory for something, if we're distracted by something, if we have to do several things at once."

She and Krumholz both cited the "Swiss cheese effect."

The concept arose from studying aviation errors, and in recent years has been applied to health care. The thinking goes: A block of Swiss cheese has a lot of holes. But only rarely do they line up so you can see all the way through. When they do, a mistake makes its way through to the patient.

This article also discusses one physician who is very transparent about a surgical error that he made. Click here to check it out.

What about physician privacy?

From the recent press release:

Consumers’ CHECKBOOK/Center for the Study of Services, a nonprofit consumer research and information organization, has won a Freedom of Information Act lawsuit that will require the U.S. Department of Health and Human Services to release data on every physician claim paid by Medicare. The data to be released will identify physicians but will not make possible identification of patients.

“Consumers, physicians, and the Medicare program itself will benefit greatly when these data are used in measures of physician experience, quality, and efficiency,” said Robert Krughoff, president of CHECKBOOK/CSS.

As a first use of the data, the consumer organization will create a resource, free to the public, on its www.checkbook.org website, that will report the number of various types of major procedures performed by each physician and reimbursed by Medicare, “so a consumer selecting a physician for a knee replacement or prostate surgery or other major procedure will be able easily to check that a physician has an appropriate level of experience,” said Krughoff.
CHECKBOOK/CSS

Might this not result in physicians "cherry picking" their Medicare cases so that they will build good stats?? Click here to access the full press release.