Washington Post, 8/22/08 (http://www.washingtonpost.com/wp-dyn/content/story/2008/08/21/ST2008082103218.html)

The Bush administration yesterday announced plans to implement a controversial regulation designed to protect doctors, nurses and other health-care workers who object to abortion from being forced to deliver services that violate their personal beliefs.

The rule empowers federal health officials to pull funding from more than 584,000 hospitals, clinics, health plans, doctors’ offices and other entities if they do not accommodate employees who refuse to participate in care they find objectionable on personal, moral or religious grounds.

“People should not be forced to say or do things they believe are morally wrong,” Health and Human Services Secretary Mike Leavitt said. “Health-care workers should not be forced to provide services that violate their own conscience.”

The proposed regulation, which could go into effect after a 30-day comment period, was welcomed by conservative groups, abortion opponents and others as necessary to safeguard workers from being fired, disciplined or penalized in other ways. Women’s health advocates, family planning advocates, abortion rights activists and others, however, condemned the regulation, saying it could create sweeping obstacles to a variety of health services, including abortion, family planning, end-of-life care and possibly a wide range of scientific research.

“It’s breathtaking,” said Robyn S. Shapiro, a bioethicist and lawyer at the Medical College of Wisconsin. “The impact could be enormous.”

The regulation drops the most controversial language in a draft version that would have explicitly defined abortion for the first time in a federal law or regulation as anything that interfered with a fertilized egg after conception. But both supporters and critics said the regulation remains broad enough to protect pharmacists, doctors, nurses and others from providing birth control pills, Plan B emergency contraception and other forms of contraception, and explicitly allows workers to withhold information about such services and refuse to refer patients elsewhere.

“The Bush administration’s proposed regulation poses a serious threat to women’s health care by limiting the rights of patients to receive complete and accurate health information and services,” said Cecile Richards of the Planned Parenthood Federation of America. “Women’s ability to manage their own health care is at risk of being compromised by politics and ideology.”

Leavitt said he requested the new regulation after becoming alarmed by reports that health-care workers were being pressured to perform duties they found repugnant. He cited moves by two professional organizations for obstetricians and gynecologists that he said might require doctors who object to abortions to refer patients to other physicians who would provide them.

An early draft of the regulation that leaked in July triggered a flood of criticism from women’s health activists, family planning advocates, members of Congress and others. Concern focused on fears that the definition of abortion could be interpreted to include many forms of widely used contraception.

“Words in that draft led some to misconstrue the department’s intent,” Leavitt told reporters during a telephone news conference. “This regulation . . . is consistent with my intent to focus squarely on the issue of conscience rights. This specifically goes to the issue of abortion and conscience.”

But when pressed about whether the regulation would protect health-care workers who consider birth control pills, Plan B and other forms of contraception to be equivalent to abortion, Leavitt said: “This regulation does not seek to resolve any ambiguity in that area. It focuses on abortion and focuses on physicians’ conscience in relation to that.”

Both supporters and critics said the language remains broad enough to apply to contraceptives, as well as many other areas in medicine.

“I think this provides broad application not just to abortion and sterilization but any other type of morally objectionable procedure and research activity,” said David Stevens of the Christian Medical and Dental Association. “We think it’s badly needed. Our members are facing discrimination every day, and as we get into human cloning and all sorts of possibilities, it’s going to become even more important.”

Leavitt stressed that there was nothing in the regulation that would prevent any organization from providing any type of care.

“There is nothing in this rule that would in any way change a patient’s right to a legal procedure,” he said.

The regulation, which would cost more than $44 million to implement, was aimed at enforcing several federal laws that have been on the books since the 1970s and were aimed primarily at protecting doctors and nurses who did not want to perform abortions in the wake of the Supreme Court’s Roe v. Wade decision, Leavitt said.

But critics said they remained alarmed at the scope of the regulation, which could apply to a wide range of health-care workers. For example, the regulation would cover “participating in any activity with a reasonable connection to the objectionable procedure, including referrals, training, and other arrangements for offending procedures.

“For example, an operating room nurse would assist in the performance of surgical procedures; an employee whose task it is to clean the instruments used in a particular procedure would be considered to assist in the performance of the particular procedure,” the regulation states.

AP, 8/21/08:  The cardio drug prasugrel outperformed its competition, the blockbuster Plavix, in preventing recurring events like heart attacks for some patients, drug maker Eli Lilly and Co. said Thursday.

Indianapolis-based Lilly, which developed prasugrel with its Japanese partner, Daiichi Sankyo Co., released more data from a late-stage trial that compared prasugrel to Plavix, the world’s second-best selling drug.

The latest release focuses on a subset of patients who have acute coronary syndromes like heart attacks or unstable anginas.

These patients survived their first cardiovascular event, which could be a heart attack or stroke, and had an artery-opening procedure involving balloon angioplasty and usually the insertion of a stent. The study then examined whether the patients had more cardiovascular events
Lilly said about 11 percent of patients taking its drug had additional cardiovascular events, compared with 15 percent taking Plavix.

The research drew a “very meaningful” conclusion from the doctor and patient’s perspective, said Dr. Elliott Antman, principal investigator in the study, which was funded by Lilly and Daiichi Sankyo.

“You want to know how many total events can I prevent with one drug versus another,” said Antman, director of the Samuel A. Levine Cardiac Unit at Boston’s Brigham and Women’s Hospital. “From a patient’s perspective, they want to not have any heart attacks. If they have one, they certainly don’t want to have a second one or a third one.”

Lilly and Daiichi Sankyo hope to gain Food and Drug Administration approval of prasugrel to treat patients with acute coronary syndromes who are at risk of developing blood clots.

Previously released results of the head-to-head study showed that fewer patients taking prasugrel developed blood clots in stents or suffered heart attacks, strokes or heart-related deaths when compared to those taking Plavix. However, the study also showed that major bleeding occurred in a higher percentage of patients taking prasugrel.

Lilly and Daiichi Sankyo submitted prasugrel last December, and the FDA granted priority review.

But the agency said in June, shortly before it was expected to make a decision, that it needed three more months. The FDA now plans to rule on the application by Sept. 26.

If approved, prasugrel would compete against Plavix, which is made by Bristol-Myers Squibb Co. and Sanofi-Aventis SA. Bristol-Myers executives have said they consider prasugrel a niche drug that targets only a small percentage of Plavix patients.

Analysts have said prasugrel could bring in anywhere from $600 million in annual revenue to more than $1 billion. Lilly faces patent expirations for several key drugs, starting in 2011

AP, 8/21/08 :   

Diversified health care products company Johnson & Johnson said Thursday the Food and Drug Administration wants more information on the company’s filing for Doribax as a treatment for hospital-acquired pneumonia.

The drug is already approved as treatment for intra-abdominal and urinary tract infections.

The company initially submitted the pneumonia application for Doribax, an intravenous antibiotic, in June 2007. J&J did not give details about the FDA request, but said it is reviewing the letter and will work to resolve any outstanding issues.

In July, the FDA’s Anti-Infective Drugs Advisory Committee voted that the drug was effective at treating hospital-acquired pneumonia, but did not agree on the whether the goal set in clinical trials for the drug was justified, J&J said in a statement.

HeartWire (8/21, O’Riordan) reported that “using the radial artery for access to the heart during percutaneous coronary intervention (PCI) is extremely rare in clinical practice, but despite its limited use, the approach is associated with equivalent procedural success to femoral access as well as lower rates of bleeding and vascular complications,” according to research published in the Journal of the American College of Cardiology: Cardiovascular Interventions.

Investigators “identified 593, 094 patients who underwent PCI between January 2004 and March 2007.” Just “1.32 percent were treated using radial-artery access. Despite the limited use of radial PCI during the period, the approach was associated with a similar rate of success and a 58 percent lower risk of bleeding complications.” The researchers also found that “the reduction in bleeding was even more pronounced among women, the elderly, and patients undergoing PCI for acute coronary syndrome.”

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5733a1.htm

Source: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5733a1.htm

Intro: According to the CDC, more measles cases have been reported in the first seven months of this year than have been reported in any seven-month period since 1996, MMWR, August 22, 2008 / 57(33);893-896

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5733a1.htm

Sporadic importations of measles into the United States have occurred since the disease was declared eliminated from the United States in 2000 (1). During January–July 2008, 131 measles cases were reported to CDC, compared with an average of 63 cases per year during 2000–2007.* This report updates an earlier report on measles in the United States during 2008 (2) and summarizes two recent U.S outbreaks among unvaccinated school-aged children. Among those measles cases reported during the first 7 months of 2008, 76% were in persons aged <20 years, and 91% were in persons who were unvaccinated or of unknown vaccination status. Of the 131 cases, 89% were imported from or associated with importations from other countries, particularly countries in Europe, where several outbreaks are ongoing (3,4). The findings demonstrate that measles outbreaks can occur in communities with a high number of unvaccinated persons and that maintaining high overall measles, mumps, and rubella (MMR) vaccination coverage rates in the United States is needed to continue to limit the spread of measles.

Measles cases in the United States are reported by state health departments to CDC using standard case definitions^† and case classifications. Cases acquired outside the United States are categorized as importations. Those acquired inside the United States are considered importation associated if they are linked epidemiologically via a chain of transmission to an importation or have virologic evidence of importation.^§ Other cases are classified as having an unknown source. In the United States, recommendations for MMR vaccination include a single dose at age 12–15 months and a second dose at the time of school entry (5). Vaccination as early as age 6 months is recommended for U.S. children traveling abroad and is sometimes recommended within U.S. communities during outbreaks of measles.

During January 1–July 31, 2008, 131 measles cases were reported to CDC from 15 states and the District of Columbia (DC): Illinois (32 cases), New York (27), Washington (19), Arizona (14), California (14), Wisconsin (seven), Hawaii (five), Michigan (four), Arkansas (two), and DC, Georgia, Louisiana, Missouri, New Mexico, Pennsylvania, and Virginia (one each). Seven measles outbreaks (i.e., three or more cases linked in time or place) accounted for 106 (81%) of the cases. Fifteen of the patients (11%) were hospitalized, including four children aged <15 months. No deaths were reported.

Among the 131 cases, 17 (13%) were importations: three each from Italy and Switzerland; two each from Belgium, India, and Israel; and one each from China, Germany, Pakistan, the Philippines, and Russia. This is the lowest percentage of imported measles cases since 1996 (Figure 1). Nine of the importations were in U.S. residents who had traveled abroad, and eight were in foreign visitors. An additional 99 (76%) of the 131 cases were linked epidemiologically to importations or had virologic evidence of importation. The source of measles acquisition of 15 cases (11%) could not be determined.

Among the 131 measles patients, 123 were U.S. residents, of whom 99 (80%) were aged <20 years (Table). Five (4%) of the 123 patients had received 1 dose of MMR vaccine, six (5%) had received 2 doses of MMR vaccine, and 112 (91%) were unvaccinated or had unknown vaccination status. Among these 112 patients, 95 (85%) were eligible for vaccination, and 63 (66%) of those were unvaccinated because of philosophical or religious beliefs (Figure 2).

Washington. On April 28, 2008, the Washington State Department of Health received a report of several suspected measles cases in a Grant County household. The index patient had rash onset on April 12. During April 18–21, the other seven children in the household became ill with fever and rash. Three of the children developed pneumonia and were evaluated by a health-care provider who suspected measles; all three tested positive for measles-specific IgM antibody. Rash onset occurred during April 13–May 30 in 11 additional cases identified in Grant County. All of the 19 cases were linked epidemiologically, and all but one occurred in children and adolescents aged 9 months to 18 years. The 19 cases included 16 in school-aged children, among whom 11 were home schooled. Because of their parents’ philosophical or religious beliefs, none of the 16 children had received measles-containing vaccine. Specimens from eight patients were submitted for virologic testing, and all contained genotype D5, which had been circulating in Japan and parts of Europe. A possible source of the outbreak was a church conference, held March 25–29 in King County, Washington, that was attended by four of the patients, including the index patient. The conference was attended by approximately 3,000 persons, primarily students from junior high through university age from 18 states, DC, and several foreign countries. None of these countries or states has since reported confirmed cases of measles among persons who attended this conference.

Illinois. On May 19, 2008, the Illinois Department of Public Health was notified by the DuPage County Health Department about a suspected case of measles. By May 27, four confirmed cases of measles had been reported to the county, three of which were laboratory confirmed. Among the four cases, rash onsets occurred during May 17–19, suggesting a common exposure. The four patients were unvaccinated girls aged 10–14 years; all had attended an event May 5 and might have attended a home gathering 2 days earlier. Both events were attended by a teenager who had recently returned from Italy and reportedly had developed fever and rash. Although attempts to obtain further information about the traveler were unsuccessful, viral isolation from one of the four patients yielded genotype D4, a strain circulating in Italy. Through July 31, 26 additional measles cases were reported, all with epidemiologic links to the first four cases. Among the 30 cases, 14 were confirmed in DuPage County, 11 in suburban Cook County, and five in Lake County. One case occurred in a person aged 43 years. The remaining 29 cases were in persons aged 8 months–17 years, including 25 (83%) school-aged children, all of whom were home schooled and not subject to school-entry vaccination requirements. Because of their parents’ beliefs against vaccination, none of the 25 had received measles-containing vaccine.

Reported by: MA Grigg, AL Brzezny, MD, Grant County Health District; J Dawson, PhD, Chelan-Douglas Health District; K Rietberg, MPH, Public Health — Seattle & King County; C DeBolt, MPH, Washington State Dept of Health. P Linchangco, MPH, S Smith, MPH, S Jones, M Vernon, DrPH, C Counard, MD, Cook County Dept of Public Health; R Chugh, MD, S Nelson, MPH, K Green, C Petit, J Vercillo, DuPage County Health Dept; S Cesario, Lake County Health Dept; K Hunt, C Conover, MD, J Daniels, K McMahon, Illinois Dept of Public Health. SB Redd, KM Gallagher, DSc, GL Armstrong, MD, LJ Anderson, MD, JF Seward, MBBS, PA Rota, PhD, JS Rota, MPH, L Lowe, MS, WJ Bellini, PhD, Div of Viral Diseases, National Center for Immunization and Respiratory Diseases, CDC.

Editorial Note:

The number of measles cases reported during January 1–July 31, 2008, is the highest year-to-date since 1996. This increase was not the result of a greater number of imported cases, but was the result of greater viral transmission after importation into the United States, leading to a greater number of importation-associated cases. These importation-associated cases have occurred largely among school-aged children who were eligible for vaccination but whose parents chose not to have them vaccinated. One study has suggested an increasing number of vaccine exemptions among children who attend school in states that allow philosophical exemptions (6). In addition, home-schooled children are not covered by school-entry vaccination requirements in many states. The increase in importation-associated cases this year is a concern and might herald a larger increase in measles morbidity, especially in communities with many unvaccinated residents.

In the United States, measles caused 450 reported deaths and 4,000 cases of encephalitis annually before measles vaccine became available in the mid-1960s (1). Through a successful measles vaccination program, the United States eliminated endemic measles transmission (1). Sustaining elimination requires maintaining high MMR vaccine coverage rates, particularly among preschool (>90% 1-dose coverage) and school-aged children (>95% 2-dose coverage) (7). High coverage levels provide herd immunity, decreasing everyone’s risk for measles exposure and affording protection to persons who cannot be vaccinated. However, herd immunity does not provide 100% protection, especially in communities with large numbers of unvaccinated persons. For the foreseeable future, measles importations into the United States will continue to occur because measles is still common in Europe and other regions of the world. Within the United States, the current national MMR vaccine coverage rate is adequate to prevent the sustained spread of measles. However, importations of measles likely will continue to cause outbreaks in communities that have sizeable clusters of unvaccinated persons.

Measles is one of the first diseases to reappear when vaccination coverage rates fall. Ongoing outbreaks are occurring in European countries where rates of vaccination coverage are lower than those in the United States, including Austria, Italy, and Switzerland (3,4). In June 2008, the United Kingdom’s Health Protection Agency declared that, because of a drop in vaccination coverage levels (to 80%–85% among children aged 2 years), measles was again endemic in the United Kingdom (3,8), 14 years after it had been eliminated. Since April 2008, two measles-related deaths have been reported in Europe, both in children ineligible to receive MMR vaccine because of congenital immunologic compromise (4,8). Such children depend on herd immunity for protection from the disease, as do children aged <12 months, who normally are too young to receive the vaccine. Otherwise healthy children with measles also are at risk for severe complications, including encephalitis and pneumonia, which can lead to permanent disability or death.

The measles outbreaks in Illinois and Washington demonstrate that measles remains a risk for unvaccinated persons and those who come in contact with them (9,10). Each school year, parents should ensure that their children’s vaccinations are current, regardless of whether the children are returning to school, attending day care, or being schooled at home. Adults without evidence of measles immunity^¶ should receive at least 1 dose of MMR vaccine. All persons who travel internationally also should be up-to-date on their measles vaccination and other vaccinations recommended for countries they might visit. These recommendations include a single dose of MMR vaccine for infant travelers aged 6–11 months and 2 doses, administered at least 28 days apart, for children aged >12 months (5).

References

1. Orenstein WA, Papania MJ, Wharton ME. Measles elimination in the United States. J Infect Dis 2004;189(Suppl1):S1–3.
2. CDC. Measles—United States, January 1–April 25, 2008. MMWR 2008;57:494–8.
3. EuroSurveillance Editorial Team. Measles once again endemic in the United Kingdom. Eurosurveillance 2008;13:1. Available at http://www.eurosurveillance.org/viewarticle.aspx?articleid=18919.
4. Filia A, De Crescenzo M, Seyler T, et al. Measles resurges in Italy: preliminary data from September 2007 to May 2008. Eurosurveillance 2008;13:pii=18928. Available at http://www.eurosurveillance.org/viewarticle.aspx?articleid=18928.
5. CDC. Measles, mumps, and rubella—vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome and control of mumps: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1998;47(No. RR-8).
6. Omer SB, Pan WKY, Halsey NA, et al. Nonmedical exemptions to school immunization requirements: secular trends and association of state policies with pertussis incidence. JAMA 2006;296:1757–63.
7. Gay NJ. The theory of measles elimination: implications for the design of elimination strategies. J Infect Dis 2004;189(Suppl1)S27–35.
8. UK Health Protection Agency. Confirmed measles cases in England and Wales—an update to end-May 2008. Health Protection Report 2008;2(25). Available at http://www.hpa.org.uk/hpr/archives/2008/news2508.htm.
9. Parker AA, Staggs W, Dayan GH, et al. Implications of a 2005 measles outbreak in Indiana for sustained elimination of measles in the United States. N Engl J Med 2006;355:447–55.
10. Dayan GH, Ortega-Sanchez IR, LeBaron CW, Quinlisk MP, Iowa Measles Response Team. The cost of containing one case of measles: the economic impact on the public health infrastructure—Iowa, 2004. Pediatrics 2005;116:e1–e4.

* Based on nationally notifiable disease data for 2000–2007.

^† CDC/Council of State and Territorial Epidemiologists measles clinical case definition: an illness characterized by a generalized maculopapular rash for >3 days, a temperature of >101°F (>38.3°C), and cough, coryza, or conjunctivitis. A case is considered confirmed if it is laboratory confirmed (using serologic or virologic methods) or if it meets the clinical case definition and is epidemiologically linked to a confirmed case.

^§ A case is considered to have virologic evidence of importation if it is within a chain of transmission from which a measles virus is identified that is not endemic in the United States.

^¶ Documented receipt of 2 doses of live measles virus vaccine, laboratory evidence of immunity, documentation of physician-diagnosed measles, or birth before 1957.

MedWire, 8/22/08 (http://www.medwire-news.md/news/article.aspx?k=48&id=77159):

Mycoplasma pneumoniae (Mp), an infection that often goes undetected, can block the natural protective response of the lung against tobacco smoke, according to US researchers.

The findings could point to a mechanism that may cause smokers to develop chronic obstructive pulmonary disease (COPD), Brian Day and colleagues from the National Jewish Medical & Research Center in Denver, Colorado, explain in the journal Infection and Immunity.

“Although smoking is the overwhelming cause of chronic obstructive pulmonary disease (COPD), only 20% of smokers develop the disease,” Day said. “Our findings suggest that Mp infection may be one of the co-factors that lead to COPD and other diseases among smokers.”

Chronic cigarette smoking evokes a lung glutathione adaptive response that results in elevated glutathione levels, but previous studies have indicated that lung infections might affect the protective response of the lung. Mp is a common lung pathogen and the most common cause of pneumonia, but can be difficult to detect because it is challenging to grow in culture.

Day and team infected mice with Mp, and found it had a mild effect, slightly lowering glutathione levels in the lungs of mice breathing fresh air. However, mice that were exposed to tobacco smoke and then infected with Mp had significantly reduced glutathione levels.

“The Mp infection completely blocked the protective response mice normally mount against tobacco smoke, reducing antioxidant levels well below even those of mice breathing fresh air,” said Day.

In addition, the team found that mice exposed to tobacco smoke and Mp had much higher levels of oxidized glutathione and lower levels of reduced glutathione, along with significantly lowered levels of the enzyme glutathione reductase.

“The Mp infection blocked the lungs’ protective response to tobacco smoke by lowering levels of the enzyme that normally recycles oxidized glutathione back into its protective, reduced form,” said Day. “This resulted in severe oxidative stress and increased tissue damage as measured by oxidized DNA.”

He adds: “These higher levels of oxidative stress and damage are likely to predispose smokers with Mycoplasma infections to lung disease, such as COPD or cancer.”

Day concludes: “These studies suggest Mp infection synergizes with ETS and suppresses the lung’s ability to respond appropriately to environmental challenges leading to enhanced oxidative stress.”