UPI (8/5) reports that “[w]hat most U.S. adults want in a doctor is a good bedside manner and communications skills,” according to a survey conducted by the American Board of Medical Specialties.

In May, investigators polled 1,009 adults, and found that “95 percent of respondents rank communication skills and board certification highest in important qualities they look for in choosing a doctor.” But, “most (respondents) didn’t understand the meaning of board certification.”

Intro:  After all the hoopla, this study shows that nothing really has changed for these residents, at least in terms of being overworked & under-rested.  Except for a drop in burn-out, rates of motor vehicle crashes, occupational exposures, depression, and self-reported medical errors and overall ratings of work and educational experiences did not change for the study subjects.  

TITLE:  Effects of the Accreditation Council for Graduate Medical Education Duty Hour Limits on Sleep, Work Hours, and Safety
Christopher P. Landrigan, Amy M. Fahrenkopf, et al.
PEDIATRICS Vol. 122 No. 2 August 2008, pp. 250-258 (doi:10.1542/peds.2007-2306)

ABSTRACT

OBJECTIVE. To mitigate the risks of fatigue-related medical errors, the Accreditation Council for Graduate Medical Education introduced work hour limits for resident physicians in 2003. Our goal was to determine whether work hours, sleep, and safety changed after implementation of the Accreditation Council for Graduate Medical Education standards.

METHODS. We conducted a prospective cohort study in which residents from 3 large pediatric training programs provided daily reports of work hours and sleep. In addition, they completed reports of near-miss and actual motor vehicle crashes, occupational exposures, self-reported medical errors, and ratings of educational experience. They were screened for depression and burnout. Concurrently, at 2 of the centers, data on medication errors were collected prospectively by using an established active surveillance method.

RESULTS. A total of 220 residents provided 6007 daily reports of their work hours and sleep, and 16 158 medication orders were reviewed. Although scheduling changes were made in each program to accommodate the standards, 24- to 30-hour shifts remained common, and the frequency of residents’ call remained largely unchanged. There was no change in residents’ measured total work hours or sleep hours. There was no change in the overall rate of medication errors, and there was a borderline increase in the rate of resident physician ordering errors, from 1.06 to 1.38 errors per 100 patient-days. Rates of motor vehicle crashes, occupational exposures, depression, and self-reported medical errors and overall ratings of work and educational experiences did not change. The mean length of extended-duration (on-call) shifts decreased 2.7% to 28.5 hours, and rates of resident burnout decreased significantly (from 75.4% to 57.0%).

CONCLUSIONS. Total hours of work and sleep did not change after implementation of the duty hour standards. Although fewer residents were burned out, rates of medication errors, resident depression, and resident injuries and educational ratings did not improve.

HealthDay, 8/4/08  (http://www.healthday.com/Article.asp?AID=617974): 

“The widely used anti-clotting drug Plavix appears to have a stronger effect in people who smoke, a study indicates…

“…The study of 259 people given Plavix because of coronary conditions found that those who smoked had significantly less clot formation than nonsmokers…Cigarette smoking increases the production of CYP1A2, a liver enzyme that converts the drug to its active form…The findings were expected to be published in the Aug. 12 issue of the Journal of the American College of Cardiology…”

Bloomberg News, 8/5/08 reported that Novartis AG has “won U.S. regulatory approval for its Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (amlodipine and valsartan)” hypertension medications.

Novartis said that the “Food and Drug Administration (FDA) approved the products, which combine two treatments into one pill, as initial therapies for” patients with hypertension.

NY Times, 8/5/08 (http://www.nytimes.com/2008/08/05/business/05drug.html?_r=3&partner=rssnyt&emc=rss&oref=slogin&oref=slogin&oref=slogin)

reports according to the findings of a clinical trial presented at the American Diabetes Association annual conference “Byetta (exenatide), an injectable drug that lowers blood sugar,” may help patients with type 2 diabetes live longer.

In the study, researchers gave Byetta to approximately 825 patients in the 10,000-patient Accord trial, and found that “[p]atients who took Byetta had a much lower chance of dying, about 75 percent lower, than those who took any other drug.” The Times notes that “[f]or the Accord finding to be proved, it must be tested in a large trial that would compare the cardiac health and overall death rates of thousands of patients, half receiving Byetta, and half receiving a placebo.” But, so far, Eli Lilly and Amylin Pharmaceuticals, the drugmakers that jointly market the drug, “have not committed to undertaking such a trial, which would take years, and cost tens of millions of dollars.”

Intro:  Rapid oral HIV testing in the ER is not all it’s cracked up to b, based on this new study.  Too many false-positives. 

TITLE:  Revising Expectations from Rapid HIV Tests in the Emergency Department

Journal:  Ann Intern Med,  (5 August 2008 Volume 149 Issue 3 )

AUTHORS:  Rochelle P. Walensky, Christian Arbelaez, et al.

BACKGROUND:  Few studies have examined the performance characteristics of rapid oral HIV testing. Walensky and colleagues found that 39 of 849 adults who visited an urban emergency department had a reactive result on rapid oral HIV testing. Confirmatory tests showed that 26 of these 39 patients were not HIV-infected, a much higher rate of false-positive results than expected. Reactive results increased the odds of HIV infection 8-fold to 32-fold compared with the pretest odds. Rapid oral HIV testing can help identify patients with greater odds of HIV infection.

ABSTRACT

Background: Expanded HIV screening efforts in the United States have increased the use of rapid HIV tests in emergency departments. The reported sensitivity and specificity of rapid HIV tests exceed 99%. Objective: To assess whether a reactive rapid oral HIV test result correctly identifies adults with HIV infection in the emergency department.

Intro:  ER personnel are not really surprised by these estimates mentioned below.  These people come in every day to any ER to seek help, decent, hard-working most of them.  Many come in as a last resort as their condition gradually worsens and takes on proportions that would even make Arnold Schwarzeneggar clutch his crotch.

TITLE:  A National Study of Chronic Disease Prevalence and Access to Care in Uninsured U.S. Adults

AUTHORS:  Andrew P. Wilper, Steffie Woolhandler, et al.

Journal:  Ann Intern Med, 8/5/08

BACKGROUND:  Some claim that U.S. persons without health insurance do not typically have ongoing health care needs. Using data from the National Health and Nutrition Examination Survey, Wilper and associates estimate that more than 11 million working-age Americans without health insurance have cardiovascular disease, hypertension, diabetes, dyslipidemia, obstructive lung disease, or previous cancer. Chronically ill patients without insurance were less likely than those with coverage to visit a health professional and were more likely to identify an emergency department as their standard site of care.

ABSTRACT

Background: No recent national studies have assessed chronic illness prevalence or access to care among persons without insurance in the United States. Objective: To compare reports of chronic conditions and access to care among U.S. adults, by self-reported insurance status.

MedPage Today, 8/5/08 (http://www.medpagetoday.com/PrimaryCare/AlternativeMedicine/tb/10410): 

“Complementary medicine, primarily related to faith and spirituality, is used by more than 60% of cancer survivors, according to an American Cancer Society study.

Prayer and spiritual practice were cited by 61.4% of more than 4,000 cancer survivors who participated in a survey, Ted Gansler, M.D., of the society’s health promotions division, and colleagues reported online in Cancer.

More than 40% of the survey participants mentioned use of relaxation, faith or spiritual healing, and nutritional supplements or vitamins. By contrast, use of hypnosis, biofeedback, and acupuncture was reported by 1% or fewer of the cancer survivors…”

TITLE:  A population-based study of prevalence of complementary methods use by cancer survivors

Gansler T, et al “A population-based study of prevalence of complementary methods used by cancer survivors. A report from the American Cancer Society’s Studies of Cancer Survivors” Cancer 2008; 113: 1048-1057.

ABSTRACT

Intro:  Why did it take so long?  I wonder if the latest Sichuan EQ was an indirect result of the experts’ dropping their teeth when they read the new rules.

MedPage Today, 8/5/08 (http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/10424):

“The FDA announced tougher conflict-of-interest rules today for members of its independent advisory committees and changed the way they will vote yea or nay to recommend approval of a drug or device.

The agency said that advisers would not be allowed to participate on a committee if they or a minor child or spouse own a conflicting financial interest worth more than $50,000 — half the old automatic exclusion level.

Previously, potential advisory committee members were screened to determine whether they had a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee’s recommendations.

Those with investments exceeding $100,000 in a company likely to be affected by the meeting outcome or those whose investments exceed 15% of their net worth were automatically excluded. A lower level of investment conflict was permitted but a waiver was needed.

Now the agency has established a firm financial cap.

In order to issue a conflict-of-interest waiver for those who have no financial interest, or a less-than $50,000 financial interest, the new guidelines would require the agency to prove that that the adviser has “essential expertise” that is unique.

At the same time, the agency has established new voting rules to ensure that individual members will not influence others with their votes.

Instead of one-by-one voting, all committee members will vote simultaneously to diminish the chance that individual members will be swayed by “voting momentum,” said the FDA.

The guidelines also clarify when the FDA should consult an advisory committee. Although the FDA is legally required to consult an advisory panel in some instances, the agency often decides on a case-by-case basis whether to call in outside opinion.

The new guidelines provide a three-pronged test to determine whether to convene an advisory panel: if the matter is of “significant public interest,” if the matter is extremely controversial, or if an advisory panel is necessary to provide the expertise needed for full consideration of a matter by the FDA.

When it comes to products that have never before been used in humans, or if the product is the first to be approved in its class, the FDA must either refer the product to an advisory committee, or provide an “action letter” explaining why the product was approved before a committee recommended its use in humans.

Except for new rules on waiver, the other new guidelines will go into effect immediately.”

FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees The Food and Drug Administration today (8/4/08) announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.  

The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance.  The FDA announced the availability of the guidance documents in today’s Federal Register; copies of all of the guidances are available on FDA’s website.  Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days.

“The FDA’s regulatory decisions affect the health of millions of Americans, and we don’t make those decisions in a vacuum,” said Randall Lutter, Ph.D., deputy commissioner for policy.  “It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent. Today’s announcement strengthens our processes.” 

FDA advisory committees are panels of independent, outside experts — often the world’s leading authorities in their fields — who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues.  Last year FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children.

Two of the guidance documents address FDA’s processes for evaluating and disclosing information about potential conflicts of interest and FDA waivers allowing participation in advisory committee meetings.  Prior to each meeting, advisory committee members are screened by FDA staff to determine whether they have a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee’s recommendations. Today, FDA is instituting a cap of $50,000 as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting. If an advisor’s personal financial interest is greater than $50,000, he or she will not be allowed to participate in that meeting. If less than $50,000, FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the advisor’s particular expertise.  Waivers, which include a description of the advisor’s personal financial interest and why the need for the expertise was essential, will all be posted on the FDA’s web site in advance of the meeting. FDA intends to use new templates for waivers and financial interest disclosure that will make them clearer and more consistent.

Another improvement addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. As detailed in the final guidance on advisory committee briefing materials, FDA intends to post briefing materials given to advisory committee members prior to a meeting on the FDA’s web site at least 48 hours before the meeting is scheduled to occur. The guidance document provides details on preparing and submitting documents to FDA for inclusion in the briefing materials, and also recommends a timetable that sponsors should follow when submitting such documents.

The agency also issued recommendations addressing the way that advisory committees will vote on questions, so as to avoid even the perception of any manipulation of votes.  It is recommended that advisory committees use a process of simultaneous voting, in which all members vote at once. Previously, advisory committees sometimes voted sequentially, with the committee chair calling on each member individually and asking them to announce their vote aloud. Simultaneous voting avoids “voting momentum” in which some voters may be influenced, even subconsciously, by the votes of those who precede them. The agency also recommends that the results of votes be announced immediately in the meeting, and FDA intends to post on the FDA website a list indicating how each member voted.  Any posted list will be part of the permanent record of the meeting.

FDA also proposed new criteria to clarify when the agency should refer a matter to an advisory committee.  In some instances FDA is required by law to refer a matter to an advisory committee.  In other instances, FDA would consider these new criteria when deciding whether to refer a matter to an advisory committee. The draft guidance being published for public comment is designed to make FDA’s advisory committee process more predictable and transparent.

The agency also has made improvements to the advisory committee web site to make it easier for users to access news on advisory committee meeting dates, agendas, financial disclosures and briefing materials.  

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Final Guidance on Procedures For Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees

Final Guidance on Public Availability of Advisory Committee Members’ Financial Interest Information and Waivers

Final Guidance on Voting Procedures at Advisory Committee Meetings

Final Guidance on Preparation and Public Availability of Information Given to Advisory Committee Members

Draft Guidance on When FDA Convenes an Advisory Committee

Fact sheet summarizing all five of the August 2008 advisory committee guidance documents

Consumer Article: Strengthening the Advisory Committee Process

FDA Advisory Committee home page