Are people on a low-carb diet replacing starches and sugars with unhealthy high-fat foods? A new survey suggests they may do something radically different.

A recent study of an internet-based support group (Active Low-Carber’s Forum: forum.lowcarber/) suggests that the major change in eating patterns for dieters on low-carbohydrate diets has been the addition of large amounts of vegetables and salads to replace carbohydrates removed from their diet. The report was published today in the open access journal Nutrition Journal (no subscription required: nutritionj).

Richard Feinman, PhD, principal author and a professor of biochemistry at SUNY Downstate Medical Center, notes that 54% of forum dieters increased salad greens and 34% increased green vegetables by “at least double their usual consumption” in response to removing starches and sugars from their diets.

Few of the 3,000 respondents reported that they had drastically increased consumption of such high-fat foods as beef, bacon, or butter, popularly portrayed as features of low-carbohydrate diets. This was especially true of the half of the respondents who had lost 30 lbs or more and kept the weight off for more than one year. A doubling of consumption of chicken, however, a lower-fat food, was reported by 34% of the dieters.

Other surprising results from the survey were attitudes of family practitioners. Half of the respondents reported consulting a health professional prior to or during dieting. Of these, 55% stated that their health professional was supportive, and another 30% found the physician had no opinion but was supportive after good results were reported.

“The real import of the work,” says Dr. Feinman, “is that physicians can prescribe a diet for people who want to do low carb that involves replacing starch and sugar with green vegetables and salads, a diet that few could object to on conventional health- or nutrition-related grounds.”

Dr. Feinman observed that people on the low-carb forum followed diets that had no portion control beyond their own natural responses to carbohydrate restriction, but he noted, “Those physicians who want to prescribe a fixed diet could use the actual behavior of this group as a model.”

“Most people were happy with the diet and a section of narrative comments produced consistent responses of ‘have more energy,’” Dr. Feinman added.

The Active Low-Carber’s Forum currently has more than 89, 000 members and their site asserts, “1,229,589 lbs lost by 59,754 members.”

SUNY Downstate Medical Center

450 Clarkson Ave., Box 2

Brooklyn, NY 11203

United States

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In what is believed to be the first meeting of its kind, Yale University is convening nearly 40 experts on nutrition, obesity, and addiction on July 9th and 10th to discuss the controversial topic of food and addiction.

Nora Volkow, M.D., director of the National Institute on Drug Abuse, will be the keynote speaker Monday evening at the private meeting in New Haven. “It is important that we study the reasons that people behave in unhealthy ways even when they are aware of potentially devastating consequences,” Volkow said. “We believe we can learn a lot about obesity by looking at what we know about the science of drug addiction. In this meeting we will be discussing the commonalities in the brain’s reward mechanisms related to compulsive eating as well as drug use for non-medical reasons.”

Among the topics of discussion for the meeting: MRI research and other work that shows strong similarities in ways drugs and certain foods affect the brain; the relationship between eating and reward systems in the brain; psychological similarities between food cravings and cravings for drugs, and the implications of this work for government policy, clinical intervention, and the law.

Although terms such as “chocoholic” and “carbohydrate addict” are prevalent in popular culture, there is little scientific consensus about food as an addiction, said Yale Psychology Professor Kelly Brownell, who is co-chair of the meeting.

“Everything changes if food is found to have addictive properties, especially the legal and legislative landscape around marketing foods to children,” said Brownell, director of the Rudd Center for Food Policy and Obesity at Yale, which is hosting the meeting. “People often use the language of addiction to explain their relationship with food cravings, withdrawal, irresistible impulses-it is all there.”

Co-chair Mark Gold of the University of Florida, who will address the meeting Tuesday, said that in the past, addiction was defined by tolerance and withdrawal. “After our work and that of others on cocaine, it was clear that addiction was more like a pathological, often fatal attraction,” Gold said. “The definition of addiction was changed and gambling and sex addiction were considered addictions. Overeating and obesity are candidates for Addictive Disease and such a hypothesis is both testable in humans and can produce novel approaches and treatments for a major public health problem.”

Gold said that food, especially highly palatable food, can produce the same effects as drugs of abuse. “It is common for people to eat more than they intend despite dire consequences,” he said. “Failed diets and attempts to control overeating, preoccupation with food and eating, shame, anger, and guilt look like traditional addictions.”

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Postmenopausal women who take hormone therapy – estrogen plus progestin – not only have an increased risk of developing breast cancer, but also of a faster progressing one, researchers from the Los Angeles Biomedical Research Institute reveal in an article published in the peer-reviewed journal JAMA (Journal of the American Medical Association). Taking into account both risks, the risk of breast cancer death is also higher, the investigators report after following-up participants in the Women’s Health Initiative (WHI) for approximately 11 years.

Hormone therapy, often referred to when treating women for perimenopausal symptoms as hormone replacement therapy (HRT), is a system of medical treatment for surgically menopausal, premenopausal and also postmenopausal women to a lesser extent. It is aimed at preventing discomfort caused by falling levels of circulating estrogen and progesterone hormones. Hormone therapy involves using one or more of a group of drugs designed to artificially increase hormone levels, mainly levels of estrogens, progesterone (pregostins), and occasionally testosterone. In this text, the researchers focused on women receiving combination estrogen plus progestin.

The researchers looked at the outcomes of a Women’s Health Initiative randomized, placebo-controlled clinical trial of estrogen plus progestin hormone therapy. They found that following an intervention period of 5.6 years and 7.9 years of average follow-up, the incidence of breast cancer was significantly higher among participants in the hormone therapy group compared to those on placebo.

The scientists wrote:

..questions of clinical relevance remain, including the cumulative, long-term effect of estrogen plus progestin on breast cancer incidence and whether breast cancer mortality is increased by combined hormone therapy use.

Rowan T. Chlebowski, M.D., Ph.D., not only examined data and revised information on the incidence of breast cancer, but also cancer mortality details of women in the WHI trial who received combined hormone therapy, which had never been done before.

The WHI trial consisted of 16,608 females from 40 clinical centers in the USA, all were postmenopausal, none of them had had a hysterectomy – they were aged between 50 and 79 years. They were randomly selected to receive either equine estrogens, 0.625 mg/d, plus medroxyprogesterone acetate, 2.5 mg/d or a placebo – in both groups they were given identically-looking pills. The trial was completed on March 31 2005, after which 83% of them (12,788) consented to follow-up monitoring for breast cancer.

The investigators found that the invasive breast cancer rate among those on combined hormone therapy was 0.43% compared to 0.34% for those on placebo. 23.7% of the hormone therapy group women who developed breast cancer had positive lymph nodes versus 16.2% in the placebo group.

Put simply, not only did more hormone therapy participants develop breast cancer compared to those on placebo, but a higher percentage of hormone therapy patients also had more advanced breast cancer.

The authors wrote:

More women died of breast cancer in the combined hormone therapy group compared with the placebo group (25 deaths [0.03 percent per year] vs. 12 deaths [0.01 percent per year]), representing 2.6 vs. 1.3 deaths per 10,000 women per year, respectively. Consideration of all-cause mortality after breast cancer diagnosis provided similar results; among women in the combined hormone therapy group, there were 51 deaths (0.05 percent per year) compared with 31 deaths (0.03 percent per year) among women in the placebo group, representing 5.3 vs. 3.4 deaths per 10,000 women per year, respectively.

With some exceptions, the preponderance of observational studies have associated combined hormone therapy use with an increase in breast cancers that have favorable characteristics, lower stage, and longer survival compared with breast cancers diagnosed in nonusers of hormone therapy. However, in the WHI randomized trial, combined hormone therapy increased breast cancer risk and interfered with breast cancer detection, leading to cancers being diagnosed at more advanced stages. Now, with longer follow-up results available, there remains a cumulative, statistically significant increase in breast cancers in the combined hormone therapy group, and the cancers more commonly had lymph node involvement. The observed adverse influence on breast cancer mortality of combined hormone therapy can reasonably be explained by the influence on breast cancer incidence and stage.

The researchers note that there was a considerable drop in breast cancer incidence in the USA after significantly fewer women were on hormone therapy following the initial reports from the WHI trial linking such therapy with breast cancer risk.

The authors add:

The adverse influence of estrogen plus progestin on breast cancer mortality suggests that a future reduction in breast cancer mortality in the United States may be anticipated as well.

Accompanying Editoria
Peter B. Bach, M.D., M.A.P.P., of Memorial Sloan-Kettering Cancer Center, New York, commented:

..the available data dictate caution in the current approach to use of hormone therapy, particularly because one of the lessons from the WHI is that physicians are ill-equipped to anticipate the effect of hormone therapy on long-term health. Clinicians who prescribe brief courses of hormone therapy for relief of menopausal symptoms should be aware that this approach has not been proven in rigorous clinical trials and that the downstream negative consequences for their patients are of uncertain magnitude. One option – discussing with patients the risk-benefit tradeoffs in pursuit of an informed patient decision – may seem at first blush to be a reasonable approach given this lack of evidence. But the reality is that informed patient decisions are not valid when the information underlying the decision is itself speculative.

“Estrogen Plus Progestin and Breast Cancer Incidence and Mortality in Postmenopausal Women”
Rowan T. Chlebowski, MD, PhD; Garnet L. Anderson, PhD; Margery Gass, MD; Dorothy S. Lane, MD; Aaron K. Aragaki, MS; Lewis H. Kuller, MD; JoAnn E. Manson, MD, DrPH; Marcia L. Stefanick, PhD; Judith Ockene, MD; Gloria E. Sarto, MD; Karen C. Johnson, MD, MPH; Jean Wactawski-Wende, PhD; Peter M. Ravdin, MD, PhD; Robert Schenken, MD; Susan L. Hendrix, DO; Aleksandar Rajkovic, MD, PhD; Thomas E. Rohan, PhD; Shagufta Yasmeen, MD; Ross L. Prentice, PhD; for the WHI Investigators
JAMA. 2010;304(15):1684-1692. doi:10.1001/jama.2010.1500

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The Washington Post on Tuesday profiled Sidney Zion, a lawyer and journalist whose daughter’s death in a New York emergency department in 1984 prompted him to seek a series of reforms in teaching hospitals “that have revolutionized modern medical education.” Zion attributed his 18-year-old daughter’s death to inadequate staffing and supervision of medical residents, as well as residents’ exhaustion from working long hours. In May 1986, a grand jury declined a murder indictment for the physicians who cared for Zion’s daughter the night of her death, but the jury did issue a report criticizing “the supervision of interns and junior residents at a hospital in New York County.” In response to the report, New York State Health Commissioner David Axelrod established a blue-ribbon panel of experts headed by Bertrand Bell of the Albert Einstein College of Medicine to evaluate the training and supervision of physicians in the state. In 1989, the state adopted the Bell Commission’s recommendations to restrict resident work hours to no more than 80 hours per week or 24 consecutive hours and require senior physicians to be present at hospitals at all times. In 2003, the Accreditation Council on Graduate Medical Education made reduced hours and other Bell Commission recommendations mandatory for the accreditation of residency training programs across the country. According to the Post, Zion also “helped set the stage for the medical-errors movement that began in the 1990s” by “championing the cause of patients and families who believed they had been harmed by the medical profession” (Lerner, Washington Post, 11/28).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

Drew Armstrong, a health reporter for CQ, examines bipartisan Medicaid legislation cleared for House floor action, a Senate hearing about FDA funding and a Government Accountability Office report examining hospital-acquired infections in this week’s “Health on the Hill from kaisernetwork and CQ.”

Armstrong says the Medicaid legislation — which would block for one year seven different regulatory policies proposed by the Bush administration to cut back on state funding for Medicaid — has garnered support from Republicans and is now scheduled for consideration on the House floor. However, President Bush likely will veto the measure, and it is not certain if either the House or the Senate would have enough votes to override a veto, according to Armstrong.

Armstrong also says that during a hearing last week, members of a Senate Appropriations subcommittee asked FDA Commissioner Andrew von Eschenbach how much funding he needs to run the agency more effectively. Von Eschenbach said the agency has requested about $54 million in new funds, but lawmakers want to appropriate more. He also discussed efforts to improve foreign inspections of imports.

Lastly, Armstrong discusses a GAO report that found that government agencies are not doing enough to prevent hospital-acquired infections. GAO recommended that agencies such as CDC and CMS develop clear guidelines for hospitals on how they can fight infections. The report also states that there needs to be better information collecting so policymakers know more on how common the infections are, how they spread and what types of patients are affected. Armstrong says it is unclear whether lawmakers will draft legislation unless they see the need to change how the agencies are doing their jobs (Armstrong, “Health on the Hill from kaisernetwork and CQ,” 4/21).

The complete audio version of “Health on the Hill,” transcript and resources for further research are available online at kaisernetwork.

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved. Continue reading →

President-elect Barack Obama on Saturday during his weekly radio and Internet address released additional details about his economic stimulus package, which he said would include funds for Medicaid and health care information technology, Long Island Newsday reports (Brune, Long Island Newsday, 12/8). Among other measures, the package would seek to provide hospitals and physicians with access to electronic health record systems and other new medical technology (Shear, Washington Post, 12/7). Obama said that such a measure could help improve health care delivery and reduce costs (Nicholas/Hook, Chicago Tribune, 12/7).

Obama did not provide details about the total cost of the stimulus package (Schouten, USA Today, 12/8). Estimates of the cost of the package have reached as high as $1.2 trillion (Long Island Newsday, 12/8).

Prospects
According to CongressDaily, congressional Democrats acknowledge that a “deal with Republicans and the Bush White House remains unlikely before January,” an indication that “any action on a stimulus package is not expected next week” (Hunt/Sanchez, CongressDaily, 12/5). Top economic advisers to Obama and congressional Democrats hope to complete work on the package in January to allow Obama to sign the legislation when he takes office on Jan. 20, 2009.

However, on Saturday, “congressional sources expressed skepticism … that a program of such size and scope could be passed in the two weeks after Congress returns to Washington on Jan. 6,” the Washington Post reports. According to the Post, “Democrats said that even if a recovery act quickly passed the House early next year, it could take longer in the Senate, where fiscally conservative Republicans have expressed concern about adding to the soaring deficit with a massive new round of government spending” and where “Republicans could easily hold up a final vote” (Washington Post, 12/7).

NBC’s “Meet the Press” on Sunday included an interview with Obama during which he discussed details of his stimulus package (Brokaw, “Meet the Press,” NBC, 12/7).

Editorials
Denver Rocky Mountain News: The “goal of a stimulus package should be to, well, stimulate the economy — or at least stabilize rattled markets so that a recovery seems possible” and “should not primarily be a way to balance state budgets,” a News editorial states. According to the editorial, a “number of governors and lawmakers are pushing for tens of billions more to help support programs such as Medicaid,” but states “can’t just be given a blank check,” as the “danger here is that Congress may simply throw additional bundles of taxpayer money at the financial crisis — all of which amounts to long-term debt — without adopting policies that lead to a sturdy recovery” (Denver Rocky Mountain News, 12/7).

Orlando Sentinel: “States have a good case to make for federal help” through a stimulus package, as they likely will have to reduce spending for health care and other programs to address a combined $24 billion budget deficit for the current fiscal year, a Sentinel editorial states. According to the editorial, a temporary increase in federal funds for state Medicaid programs “would help close the gap in their budgets without sparing them the necessity of taking a hard look at other, less vital programs.” The editorial adds, “More cuts inevitably would drain more money from programs that serve the most vulnerable members of society — the young and old, the poor and sick — just as the bad economy is increasing the need for those programs” (Orlando Sentinel, 12/8).

Washington Times: States have asked Congress for $40 million in additional federal funds for their Medicaid programs, as well as $136 million in other funds, and they “should be required to put forth their plans to cut spending and trim their bureaucracies” before they can receive any funds, according to a Times editorial. The editorial states, “The wake-up call for governors is that it is in their states’ best interest in the short and long term to make the tough calls” (Washington Times, 12/7).

Opinion Piece
Comprehensive health care reform — “specifically, universal health care” — should “top the list” of measures included in a stimulus package because a “bold embrace of universal health care offers policymakers the chance at a fiscal triple-play: Universal coverage would stimulate the economy, it would boost the financial security of ordinary Americans and it would break the health care reform log-jam,” Chris Farrell, a contributing economics editor for BusinessWeek, writes in an opinion piece. He writes, “Universal coverage would boost the economy in the short term,” adding, “Targeting fiscal stimulus toward universal coverage would help ordinary workers rather than Wall Street tycoons” and “relieve a major source of economic insecurity for anyone handed a pink slip during the recession.” In addition, Farrell writes, “To be sure, this kind of universal health care isn’t good enough for the long haul,” but “once the economy recovers, Washington can debate how to create a more cost-effective and cost-efficient health care system” (Farrell, BusinessWeek, 12/5).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

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The pharmaceutical and medical device industries have praised the nomination of former New York City Health Commissioner Margaret Hamburg as FDA commissioner, but they are “nervous in varying degrees” about the nomination of Baltimore Health Commissioner Joshua Sharfstein as principal deputy commissioner of the agency, CongressDaily reports.

According to one lobbyist, Sharfstein likely “will have a certain amount of autonomy on pharmaceuticals and medical devices,” as Hamburg likely will focus on food safety and tobacco regulation. The lobbyist added, “Companies are clearly going to get more scrutiny” under Sharfstein.

As a former staffer for House Energy and Commerce Committee Chair Henry Waxman (D-Calif.), who “has been tough on drug companies,” Sharfstein “has a long and sometimes contentious history with the pharmaceutical industry,” CongressDaily reports. “Sharfstein has carried the torch on many of his boss’s public health priorities” — such as efforts to limit off-label use of medications and gifts from pharmaceutical companies to physicians — and he “could play a key role implementing 2007 FDA legislation” that requires pharmaceutical companies to develop risk evaluation and mitigation strategies, according to CongressDaily.

Peter Pitts, a former FDA associate commissioner for external affairs and co-founder of the Center for Medicine in the Public Interest, said that many of the concerns about Sharfstein raised by the pharmaceutical and medical device industries are unfounded. “I don’t think you’ll see more strident regulations,” he said, adding, “I think you’ll see a more effective way to use existing regulation” (Edney, CongressDaily, 3/18).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

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Federal funding for the Medical Free Electron Laser Program (MFEL), which develops advanced laser and optical applications for use in the military and on the battlefield, has been marked for elimination by the Department of Defense.

The program – with current centers at Massachusetts General Hospital, Duke University, Stanford University, the University of California at Irvine, and Vanderbilt University – has been funded for the past 20 years in the range of $16-$20 million a year. The Defense Department’s current budget projections show no funding for the program for the next six fiscal years.

In a letter to Pentagon officials, eight U.S. senators, including Senator Edward M. Kennedy (D-Massachusetts) and North Carolina Senator Elizabeth Dole (R-North Carolina), expressed their concern about the Defense Department’s proposal. “We can attest to the excellent research track record and the great promise represented by the research currently supported by the MFEL program,” the senators wrote.

Disbursing approximately $16 million in the current fiscal year, the MFEL program is a merit-based, peer-reviewed, competitively awarded research program that has funded a wide range of basic research with ties to military medicine – including laser surgery, battle injury monitoring and diagnosis, wound closing and healing, and disease containment.

While the program currently funds centers at MGH, Duke, Stanford, UC Irvine, and Vanderbilt, other institutions which have been funded in the past include the University of Utah, Baylor University, and Northwestern University, among others.

According to R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at Massachusetts General Hospital in Boston, “The MFEL program was intended to fund high-risk, potentially high-reward research to improve military and civilian medicine. The program has been extraordinarily productive by many measures, as recognized by the Defense Department and Congressional staff.”

Elimination of program funding will halt promising research nearing delivery, including nerve and blood vessel bonding for limb repair (ready for military clinical trials), and remote diagnosis and/or treatment for blast injuries, head trauma, and Leishmaniasis, a parasitic disease transmitted by sand flies.

“Providing the best possible care to our service men and women includes research and development aimed exactly at solving military medical problems.” Anderson said. “The Defense Department’s funding recommendation will divert the expertise of some premier biomedical laboratories from this mission at a critical time.”

MFEL funding has supported projects that have resulted in the following discoveries, which have both military and civilian applications:

- “Smart” laser surgery of severe skin burns.

- Laser treatment of painful and disfiguring scars.

- Laser treatment of kidney stones (lithotripsy), a common problem made worse among military personnel with dehydration from serving in desert environments.

- Laser treatments for Pseudofolliculitis Barbae, a condition affecting up to 60 percent of African American men, in which hairs grow back into the skin, causing inflammation and scarring. Close shaving and wearing a gas mask make the condition worse.

- A light-activated drug (Visudyne®) used to treat macular degeneration, the number one cause of blindness in the United States.

- A safer laser treatment of glaucoma.

- Scarless removal of tattoos and foreign body pigments, needed to ensure that qualified enlistees meet military regulations.

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of nearly $500 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine. MGH and Brigham and Women’s Hospital are founding members of Partners HealthCare HealthCare System, a Boston-based integrated health care delivery system.

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MRI reveals that greater trochanteric fractures of the hip that are diagnosed as isolated on X-ray are frequently underestimated and are neither isolated nor minor, say a pair of researchers from Presbyterian Hospital, New York, NY.

Frieda Feldman, MD, and Ronald B. Staron, MD, analyzed 37 patients over the age of fifty who had fallen and fractured their hip. All patients were diagnosed on X-ray as having greater trochanteric fractures, an injury to one of the bony protrusions near the upper part of the femur, and had follow-up MRI performed. MRI revealed more extensive fractures in 35 of the patients than the X-rays had.

According to the study, this type of fracture, usually the result of a fall, is often found in elderly patients, and X-ray is one of the standard imaging techniques performed for such an injury. “Routine X-ray imaging, in my view, is still the indispensable primary technique for imaging hip trauma. However, although X-rays may reveal greater trochanteric fractures, they do not demonstrate their full geographic extent,” said Dr. Feldman.

Being able to fully gauge the scope of the injury allows for better treatment planning, say the researchers. “While isolated greater trochanteric fractures, as defined on X-ray, have been classically treated by bed rest or limited weight bearing, the potential clinical importance of MRI lies in furnishing physicians with documentation of all the ramifications of the fracture so that more informed decisions may be made as to surgical versus nonsurgical treatment in individual cases,” said Dr. Feldman.

The article appears in the August 2004 issue of the American Journal of Roentgenology.

Contact: Jason Ocker
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Keri Sperry
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Antibiotic resistance is a worldwide public health issue. Physicians around the world face an increasing clinical challenge as many life-threatening bacterial infections, once responsive to therapy, are building resistance to the most commonly prescribed antibiotic treatments. However, preventing the occurrence of disease through vaccination may help alleviate the challenges of antibiotic resistance.

A study published in today’s New England Journal of Medicine (NEJM) – “Effect of Introduction of the Pneumococcal Conjugate Vaccine on Drug-Resistant Streptococcus pneumoniae” has found that, since the introduction of PREVNAR®, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), in the United States, the rate of antibiotic-resistant invasive pneumococcal disease (IPD) has substantially decreased in infants and young children. In addition, the rate of antibiotic-resistant IPD decreased in adults over 65 years of age, an unvaccinated group, suggesting an indirect effect in the non-vaccinated population.

The study analyzed population-based data from the Active Bacterial Core Surveillance, part of the Emerging Infections Program of the Centers for Disease Control and Prevention (CDC), and found that since the introduction of PREVNAR, IPD caused by penicillin-resistant strains targeted by the vaccine has been reduced by:

- 87 percent among the full study population (persons of any age);
- 98 percent among children younger than two years of age;
- 79 percent among adults aged 65 years or older.

The study documented significant overall reductions in antibiotic-resistant IPD, irrespective of pneumococcal serotype, although the rate of penicillin non-susceptible disease due to non-vaccine serotypes increased from 0.2 per 100,000 in 1999 to 0.5 per 100,000 in 2004. Wyeth Pharmaceuticals is developing a 13-valent pneumococcal conjugate vaccine which targets additional pneumococcal serotypes. This new vaccine is currently undergoing clinical development.

The New England Journal of Medicine findings continue to document the impact of routine immunization with PREVNAR on public health. In addition, the development of the 13-valent pneumococcal conjugate vaccine further demonstrates Wyeth’s continued dedication to helping protect infants and toddlers against invasive pneumococcal infection and its potentially devastating consequences.

IPD describes a group of illnesses, some of which may be life threatening, caused by the bacterium Streptococcus pneumoniae. S. pneumoniae has been associated with the highest level of morbidity and mortality due to bacterial meningitis in children. IPD includes serious diseases such as bacteremia/sepsis, meningitis, and bacteremic pneumonia.

PREVNAR is the first and only vaccine indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). These seven serotypes accounted for approximately 80 percent of IPD in children under age six in the United States prior to the licensure of PREVNAR.

PREVNAR is recommended by the CDC and the American Academy of Pediatrics for infants two months of age and older, and children younger than two years of age. The routine schedule is 2, 4, 6, and 12 to 15 months of age.

Since the introduction of PREVNAR in the United States, IPD incidence has decreased dramatically. Three years after the introduction of routine PREVNAR use in the United States, surveillance sites of the CDC noted a 94 percent reduction in IPD in children younger than five years of age caused by pneumococcal serotypes targeted by the vaccine, as well as a reduction in the incidence of vaccine serotype IPD in adult populations. However, reduction in IPD rates due to non-vaccine serotypes should not be expected, and PREVNAR is not indicated for use in adults.

Important Safety Information

In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever (>=38°C/100.4°F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea and rash.

Risks are associated with all vaccines, including PREVNAR. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. PREVNAR does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.

Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

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