The Agency for Healthcare Research and Quality (AHRQ) has started a new monthly peer-reviewed, Web-based medical journal that showcases patient safety lessons drawn from actual cases of medical errors. “AHRQ WebM&M (Morbidity and Mortality Rounds on the Web)” is available at webmm.ahrq.gov. The journal seeks to educate health care professionals about medical errors in a blame-free environment.

Clinicians routinely hold morbidity and mortality conferences to discuss specific cases that raise issues regarding medical errors and quality improvement. Every month, five cases of medical errors and patient safety problems (one each in medicine, surgery/anesthesiology, obstetrics-gynecology, pediatrics, and other fields including psychiatry, emergency medicine, and radiology) will be posted along with commentaries from experts and a forum for readers’ comments. Each month, one of the five cases will be expanded into an interactive learning module featuring readers’ polls, quizzes, and other elements offering continuing medical education credits. Cases are limited to near misses or those that involve no permanent harm.

The Official Organ of the Rhode Island Medical Society Issued Monthly under the direction of the Publications Committee

NINETY YEARS AGO

[MAY, 1913]

An editorial explained the Medical Society’s reluctant decision to expel two members. The first, Dr. J.B. Archambault, of Woonsocket, “although a graduate of Laval [and] a licensed practitioner of this state,” had “publicly lent his name and the profession to a . . .quack medicine.” Dr. Archambault had placed an advertisement in a local newspaper for his elixir, a “Long Life Tonic for Dyspepsia and all Female Disturbances, also a Wonderful Cough Syrup for Tuberculosis, Bronchitis, Pneumonia, Whooping Cough.” The Society also expelled Dr. George M. Bailey, MD, LLB, President of the Rhode Island College of Nursing. Dr. Bailey had advertised the school m JAMA. This correspondence course (the time could range from a few months to a year) was replacing the Rhode Island Training School for Nursing and Allied Sciences. Dr. Bailey proposed to give physicians stock in the school, in exchange for sending “fully paid students.” The advertisement promised physician-investors that they might also gain some free labor from the students.

Governor Pothier had invited Dr. Friedrich F. Friedmann of German to demonstrate at public clinics (Woonsocket Hospital, St. Joseph’s Hospital, City Hospital, and an improvised laboratory at the Narragansett Hotel) his treatment for tuberculosis. Dr. Friedmann refused to publish details of his cure. The Journal decried the visit: “That he has infected others with his sensationalism is evidenced by the hectic and perfervid comparison of his coming to America by a local minister to that of the coming of Jesus Christ.”

Henry C. Hall, MD, President, Providence Medical Association, gave the Annual Address, “Practical Aspects of Psychotherapy.” He wrote: “In the present era of medical science . . . may it not be well to pause and seriously question whether some of the old-time methods of cure are not neglected?” Specifically, he cited “suggestion” (as in faith healing, mesmerism, animal magnetism), but conceded that modern medicine was “antagonistic” to these treatments.

It helps us to think harder and do better

Readers wondering why the BMJ or any other medical journal needs an ethics committee should read the latest annual report of the United Kingdom’s Committee on Publication Ethics.[1] It describes cases that until 1997–when the committee was set up–editors had to tackle alone: authors who cannot agree on their respective contributions to a piece of research, allegations of fraud (against editors as well as researchers), victimisation of whistleblowers, investigators who slice their work up in to “least publishable units” and submit to several different journals simultaneously, and research papers that come without ethics committee approval “because there isn’t one in our hospital in [unnamed country].” Less dramatic issues come up every day: reviewers who write that they have shares in the drug company that sponsored a trial but don’t think it’s ‘affected their judgment; or editors who share manuscripts with another journal’s editors without thinking to tell the author first. Editors, just like doctors, live in a morally complex world where ethical judgments are needed constantly.

The Committee on Publication Ethics is a useful sounding board for editors needing general advice about specific anonymised cases of potential misconduct, but the BMJ needs more. It needs an ethics committee to examine critically all editorial practices, including policies on patient confidentiality and consent, declaration of competing interests, open peer review, disclosure of research results to trial participants, and relationships with the media and the developing world.

The frequency and complexity of ethical issues means that editors need help, which is why we are creating an ethics committee. An independent committee will help us with difficult cases and review our policies–clarifying those that are imprecise, telling us where we need new ones (on whistleblowing, for example) and adding legitimacy to those that are right already. A committee may not be good at painting pictures or writing sonnets, but it should make for better ethical decisions, not least because it will include experts, BMJ readers, and patients’ representatives.

hese articles scored the most hits on the BMJs website in the week of publicationSEPTEMBER

1 ABC of breast diseases: Breast cancer–epidemiology, risk factors, and genetics 2000;321:624-8 28 473 hits

2 ABC of breast diseases: Breast cancer 2000;321:745-50 28 086 hits

3 ABC of breast diseases: Screening for breast cancer 2000;321:689-93 19 165 hits

4 Recent advances: Complementary medicine 2000;321:683-6 14 797 hits

5 Recent advances: Palliative care 2000;321:555-8 13 864 hits

6 Using the internet to access confidential patient records: a case study Information in Practice 2000:321:612-4 9444 hits

7 Regular review: Improving the care of patients with genital herpes 2000:321:619-23 7147 hits

8 Clinical governance in primary care: Improving quality in the changing world of primary care General Practice 2000:321:551-4 7038 hits

9 Clinical governance in primary care: Organisational development for clinical governance General Practice 2000;321:679-82 6765 hits

10 ABC of oral health: Dental emergencies 2000;321:559-62 6652 hits

The pharmaceutical industry’s corrupting influence on our medical care system usually gets the most attention. Now its corrupting influence on medical journals has come under fire. Yes they’re full of drug ads that prompt the usual suspicions about financial dependency. But that’s the least of it, according to Richard Smith, MD, who resigned last year as editor-in-chief of the BMJ (British Medical Journal).

In a recent commentary for the Public Library of Science, a free online medical journal, Dr. Smith identified the less obvious conflicts of interest that surround the most respected form of research, the randomized clinical trial. Whenever a large trial is published in a high-profile journal, it has that journal’s implicit stamp of approval and may well receive global media coverage thanks to drug company-financed PR. A trial with favorable results will generate far more money for the drug companies than a multi-page advertising campaign, according to Dr. Smith, and that’s why they spend “upwards of a million dollars” on reprints of the trial to send around the world. Doctors won’t necessarily read the reprints, he acknowledges, but the name of a highly respected medical journal will impress them.

Here’s the most disturbing element of this scenario: More and more drug companies are getting the results they want because the trials are often rigged. Most drug trials are now sponsored by the drug companies. They can, and often do, design a trial in such a way as to get results that prove a drug’s benefit. In fact, several reviews have already found that most of the industry-funded trials have findings that favor the drug. Between two-thirds and three-quarters of trials published in the major journals–Annals of Internal Medicine, JAMA, Lancet, New England Journal of Medicine–are funded by drug companies.

The article with this title, published in the May 2005 PLoS Medicine, is particularly interesting because the author was an editor of the British Medical Journal for 25 year–and for 13 of them was editor and chief executive of the BMJ Publishing Group, responsible for the profits of the BMJ and 25 other journals. Some of his observations are different from what the public thinks.

He found that advertising was not the big problem, but “the least corrupting form of dependence. The advertisements may often be misleading and the profits worth millions, but the advertisements are there for all to see and criticise”–and people learn to discount advertising anyway. The big problem is clinical trials–which readers see as one of the highest forms of evidence, which have the journal’s stamp of approval, and which are distributed around the world, often with global media coverage. “For a drug company, a favourable trial is worth thousands of pages of advertising,” which is why companies sometimes pay more than a million dollars just to buy reprints to distribute to doctors and others. And studies have found that these published articles on trials rarely produce results unfavorable to the company that funded them. “The evidence is strong that companies are getting the results they want”–in large part by asking the right questions, which can be done in many ways, which much of the rest of the article describes.

Why doesn’t the system peer review (accepting, rejecting, or improving the articles based on reviews by scientific colleagues) catch this? The author said he “must confess that it took me almost a quarter of a century editing for the BMJ to wake up to what was happening. Editors work by considering the studies submitted to them. They ask the authors to send them any related studies, but editors have no other mechanism to know what other unpublished studies exist. It’s hard even to know about related studies that are published, and it may be impossible to tell that studies are describing results from some of the same patients.” Many journals very much want to publish randomly controlled trials (because they believe they are the best). And such articles are highly profitable for the journals.

Richard Smith, who edited the British Medical Journal (BMJ) for 25 years, wrote an essay that describes how pharmaceutical companies use medical journals to promote their products. Journals depend upon the advertising money received from drug companies, but Smith says that “this is, I suggest, the least corrupting form of dependence.” Industry’s ability to design clinical trials to increase the odds of a favorable result along with medical journals’ tendency to print positive studies is more insidious. Industry-funded trials account for 66 to 75% of all the trials published in Annals of Internal Medicine, JAMA, Lancet, and New England Journal of Medicine. Companies pay these journals millions of dollars for reprints of favorable trials. They then send these reprints, emblazoned with the journal’s name, to doctors. “The quality of the journal will bless the quality of the drug,” writes Smith. “For a drug company, a favorable trial is worth thousands of pages of advertising.”

Drug companies know how to design a technically good study; and they are continually working on new ways “to hugely increase the chance of producing favorable results.” Smith lists seven ways that companies design studies to their advantage:

* “Conduct a trial of your drug against a treatment known to be inferior.

* Trial your drugs against too low a dose of a competitor drug.

* Conduct a trial of your drug against too high a dose of a competitor drug (making your drug seem less toxic).

* Conduct trials that are too small to show differences from competitor drugs.

* Use multiple endpoints in the trial and select for publication those that give favourable results.

* Do multicentre trials and select for publication results from centres that are favourable.

* Conduct subgroup analyses and select for publication those that are favourable.

* Present results that are most likely to impress–for example, reduction in relative rather than absolute risk.”

When all else fails, companies have suppressed or, at least, significantly delayed the release of negative studies.

The BMJ is becoming more active in the US

To celebrate four centuries of British-American relations, the Library of Congress and the British Library developed the John Bull and Uncle Sam exhibition.[1] One exhibit is a cartoon that accompanied an editorial in Collier’s magazine in 1953 (figure). The editorial sought to quell anti-British feelings prompted by disparaging remarks about the US made by the British prime minister. It reminded Americans of the important ties between the two nations and suggested that they sign a “Declaration of Interdependence.” The BMJ Publishing Group is contributing to this interdependence by publishing two sister journals to the BMJ–BMJ USA, which is being launched this month, and the Western Journal of Medicine (WJM), which circulates in the western states of the US.

The interdependence is particularly evident in science and medicine. In the same year that the editorial in Collier’s was published, Francis Crick (a Briton) and James Watson (an American) announced that they had determined the structure of DNA. Nearly 50 years later teams of American and British researchers announced that they had completed a working draft of the human genome.[2-3] The concept of evidence based medicine developed in North America, but–like Jimi Hendrix–had to come to Britain to get famous.

The BMJ Publishing Group is taking several steps to promote communication and across the Atlantic. This month, in partnership with the Clinicians Group (a publisher based in Clifton, New Jersey), we are launching BMJ USA. It will be sent monthly to about 100 000 primary care physicians in the United States. Featuring articles from the weekly BMJ particularly relevant to the US, it will also contain material from other BMJ Publishing Group journals–such as Heart, Gut, and Thorax-and from Clinical Evidence. Between those items we will sprinkle content commissioned from the US, which will be available to all on bmj.com.

BMJ USA becomes one of a dozen local editions of the BMJ published throughout the world. Already it is suggesting new ways in which our local editions can be dynamic and creative. For example, it will publish selected “rapid responses” from bmj.com alongside the articles to which they relate, illustrating the debate prompted by the articles.

New medical technology is likely to further inflate future Medicare costs, posing great financial risk to the program, according to a RAND Corporation study. Emerging treatments such as implantable defibrillators or drugs to prevent Alzheimer’s disease could boost spending significantly, with single treatments potentially increasing costs by as much as 70 percent, according to a series of RAND Health reports published online by the journal Health Affairs. Some savings may be expected if disability rates among the elderly continue to drop. But those savings probably will be overshadowed by increased spending on healthy elderly recipients who will live longer, according to one of the RAND papers. Some cost savings may be possible if the nation can reduce the number of Americans who are obese. Medicare costs among obese seniors are significantly higher and the number of obese Medicare recipients is rising, according to the studies. The elderly currently spend more than $300 billion on healthcare annually. Most of this is paid for by Medicare. Researchers examined the spending increases that might face the elderly through 2030 under a number of different scenarios, including potential cost spikes caused by 10 new medical technologies that a panel of experts said are likely to emerge during the period. Some of the technologies would have small impacts, including cancer vaccines and better treatments for acute stroke, each of which is predicted to increase elderly healthcare spending by less than 1 percent. But other technologies could trigger major cost increases.

On October 30, the Wall Street Journal ran a front-page article titled “Medical Seizures: Hospitals Try Extreme Measures to Collect their Overdue Debts.” Unfortunately, focusing on how hospitals collect payment misses the core problem.

The article was part of a less-than-flattering series on hospital charging and collection practices. I commented on these issues in my August 2003 column. I also sent a letter to the editors of the Journal after this latest article, which the Journal has agreed to publish.

In my letter, I noted that I was glad substantial attention was focused on hospital collections problems–because there are significant problems. I also wrote that, unfortunately, readers might conclude the real problem relates to how hospitals pursue collections based on a case cited in the article. That case involved a hospital’s collection agency seeking arrest warrants when patients repeatedly fail to respond to payment requests and court hearings or fail to live up to payment commitments. Interestingly, using the Journal’s own numbers, these “extreme” cases amount to only 0.02 percent of the total population served by this hospital.

In my letter, I noted that how hospitals pursue collections is not the main issue. Rather, the complexities and cost of administering the U.S. healthcare system are the main issues. This fragmented and broken system of charging, billing, and collections consumes about 31 cents out of every dollar spent on health care. Medicare regulations (reported to be more voluminous than the entire IRS tax code), byzantine payment rules, 40-plus million uninsured people, complex payment formulas, and so on are the real problems. The system works against all of us, I stated in my letter, and that’s why we need to deal with these real problems. I appreciate the Journal’s willingness to air this view in its pages.

Charging and collection techniques will continue to grab headlines. Some suggest the ongoing press coverage is the result of well-funded efforts by an insurance company that sells high-deductible individual health policies and a union that is trying to unionize hospital workers. Regardless of the funding, the public-relations aspects of this issue are real.