Bush Should Sign Bill Expanding Federal Funding For Embryonic Stem Cell Research, Editorial Says

President Bush “has few allies left in the stem cell debate,” and he should sign legislation (HR 3, S 5) that would expand federal funding for human embryonic stem cell research, a Washington Post editorial says (Washington Post, 3/22). Federal funding for embryonic stem cell research is allowed only for research using embryonic stem cell lines created on or before Aug. 9, 2001, under a policy announced by Bush on that date. The House in January voted 253-174 to pass the Stem Cell Research Enhancement Act of 2007, which would allow federal funding for research using stem cells derived from embryos originally created for fertility treatments and willingly donated by patients. The measure is the same as a bill (HR 810) Bush vetoed last year, and the White House in a statement released in January reiterated Bush’s intent to veto the measure. Sen. Tom Harkin (D-Iowa) has said that if Bush vetoes the measure, then he will try to attach it to any “must-do” legislation. NIH Director Elias Zerhouni on Monday during a Senate Appropriations Committee subcommittee hearing on NIH funding for fiscal year 2008 said that he supports lifting restrictions on federal funding for embryonic stem cell research (Kaiser Daily Women’s Health Policy Report, 3/20). A “huge majority of Americans, Congress and even Mr. Bush’s NIH director have considered the implications of funding embryonic stem cell research and concluded that extracting the cells from embryos set to be discarded anyway is not objectionable enough to deny funds,” the editorials says. If the legislation reaches Bush’s “desk, he should sign it,” the editorial says, concluding, “If he does not, Congress should override his veto” (Washington Post, 3/22).

“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.

Comment On Study Into Maternal Farm Exposure – Asthma UK

‘This study adds to existing evidence supporting the hygiene hypothesis, which states that early exposure to potential allergens results in a reduced risk of asthma and allergy development. Although research has now repeatedly linked the farming lifestyle with a reduction in these conditions, it is still difficult to issue specific recommendations on how pregnant women and children should be exposed to this kind of environment in order to reduce the risk of asthma and allergies.

‘As the UK has among the highest prevalence rates of asthma symptoms in children worldwide, it is incredibly important for us to understand more about how a child’s environment in early life can affect the development of asthma and allergies and so further studies in this area are needed. The more knowledge we have, the greater the chance of preventing asthma and allergies in the first place, and the more children and families whose lives can be improved as a result.’

Source
Asthma UK

FDA Announces Meeting Information And Voting Membership Of The Tobacco Products Scientific Advisory Committee

The U.S. Food and Drug Administration announced membership and meeting information for the Tobacco Products Scientific Advisory Committee (TPSAC). The Committee, required through the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), will provide advice, information, and recommendations to FDA on a wide range of tobacco-related issues.

The first meeting of the Committee, scheduled for March 30-31, 2010, will focus on the health impacts of the use of menthol in cigarettes as it relates to the demographics of users, preferential use by persons initiating tobacco use, and the effects of menthol on addiction and cessation. In addition, consumer perceptions about menthol cigarettes, the sensory qualities of menthol cigarettes, and the effects of menthol on how cigarettes are smoked will be discussed at the Committee’s inaugural meeting.

These discussions are preliminary to the preparation of the Committee’s Report to the Secretary of Health and Human Services regarding the impact of use of menthol in cigarettes on the public’s health, required by the Tobacco Control Act.

“FDA will be faced with many challenging tobacco-related public health, science and regulatory issues as we move forward with implementation of the Tobacco Control Act,” said Lawrence R. Deyton, M.S.P.H., M.D., director of the FDA’s Center for Tobacco Products. “The breadth of knowledge amassed by this highly-qualified group will supplement and enhance the agency’s understanding of tobacco control, prevention, and health promotion issues.”

The committee is comprised of 12 members, nine voting and three non-voting. Of the nine voting members, seven are health professionals representing a wide variety of relevant disciplines. The other two voting members include a representative from state government and a representative of the general public.

Selection of the three non-voting members representing industry interests is on-going. Ultimately this will include one member from the tobacco manufacturing industry, one representing tobacco growers, and one representative from the small business manufacturing industry.

For additional background, including the roster of members, please go here.

Source
U.S. Food and Drug Administration

UK Farmers Urged To Vaccinate Against Bluetongue Threat

The UK remains at risk from the threat of bluetongue and farmers should vaccinate their animals at the earliest opportunity, the NFU said today.

Defra has launched the 2009 vaccination plan for animals susceptible to bluetongue serotype BTV8 and will continue to promote a voluntary vaccination programme. Although Defra will not be underwriting further vaccine supplies for 2009 it will be making available the remaining 12 million doses of existing stock. Farmers will also be able to source additional vaccine through the open market and should speak to their vets for further advice.

NFU livestock board chairman Alistair Mackintosh said: “Although no circulating bluetongue disease was detected in the UK this year we remain at risk and farmers cannot afford to be complacent. The disease is circulating widely in mainland Europe and there is a real danger it could re-emerge in this country next year.

“Vaccination remains the only effective way to protect susceptible animals and farmers should speak to their vets about ordering the vaccine and vaccinating their animals as soon as possible. The message remains clear – don’t hesitate, vaccinate.”

Earlier this month the NFU joined the leaders on the other UK farming unions in reiterating the call for a suspension of live cattle and sheep imports from infected areas in Continental Europe because of the threat of bluetongue.

NFU

Cigarettes Containing Low Levels Of Tar And Nicotine Also Harmful, Hong Kong Deptartment Of Health

Cigarettes containing low levels of tar and nicotine do not indicate that they are less harmful and the best way to protect health is to quit smoking, a spokesman for the Hong Kong Department of Health (DH) said (April 13).

According to the findings of the latest review of the tar and nicotine yields of 88 brands of cigarettes in Hong Kong in 2005, the spokesman said the average tar and nicotine yields in these cigarettes were 9.1 milligrams and 0.76 millgrams per cigarette (mg/cig) respectively, representing a drop of 0.8 mg/cig and 0.06 mg/cig respectively over the findings of 2004.

Of the 88 brands, 50 are classified in the low-tar group (0-9mg/cig), 37 in the middle-tar group (10-14mg/cig), and one in the high-tar group (15-17 mg/cig).

The spokesman stressed that cigarettes even in the low-tar group are harmful to smokers’ health.

“When smokers choose cigarettes in this group instead of cigarettes in the middle-tar or high-tar groups, they may take larger and more frequent puffs or even smoke more cigarettes each day.

“Quitting smoking is the only way to reduce a smoker’s risk of developing diseases such as heart disease and cancers,” the spokesman said.

In fact, the Government has proposed in the Smoking (Public Health) (Amendment) Bill 2005 to delete the tar group designation.

The spokesman said examination of tar and nicotine yields of the popular brands of cigarettes in Hong Kong had been conducted by the Government Laboratory since 1983 on an annual basis.

Members of the public can obtain details of the review for 2005 from the Government Laboratory website at govtlab.hk.

The spokesman reminded members of the public that both smoking and secondhand smoke are hazardous to health. Smoking cessation services, including counselling and nicotine replacement therapy to smokers, are provided by DH and the Hospital Authority to safeguard the health of the community.

DH also set up the Tobacco Control Office (TCO) in 2001 to coordinate and enhance the Government’s tobacco control efforts.

Members of the public may visit the TCO website at tco.hk.

info.hk/dh/new/index.htm

Artery Stiffness May Be Reversed By Long-Term Smoking Cessation

Ex-smokers achieved non-smokers’ level of arterial stiffness after a decade of smoking cessation, in a cross-sectional study reported in Hypertension: Journal of the American Heart Association.

“Smoking is a major risk factor, not only for lung disease and cancer, but also for heart attack, stroke and heart failure,” said lead author Noor Ahmed Jatoi, M.B.B.S., D.C.N., D.M.M.D. “Our group has previously shown that smoking a single cigarette, passive or second-hand smoking and chronic smoking all lead to stiffer arteries, which in turn increase resistance in the blood vessels and, therefore, increase the work the heart must do.”

However, it was not clear if smoking cessation would be associated with reduced arterial stiffness. Stiffness in the arteries can increase blood pressure and is associated with increased risk of cardiovascular events.

The researchers studied 554 people (average age 47, 56 percent female) who had high blood pressure but had never been treated for it. Researchers divided the subjects into: current smokers (150), ex-smokers (136) and never-smokers (268).

“We categorized ex-smokers according to how long they were off cigarettes – under one year, more than one but less than 10 years and more than 10 years of smoking cessation,” said Jatoi, a Ph.D. student in clinical pharmacology at Trinity Health Sciences Centre and Hypertension Clinic at St. James’s Hospital, Trinity College Dublin (University of Dublin), Ireland.

Researchers used Arterial Pulse Wave Analysis, a technology that measures arterial stiffness. They found that current and ex-smokers of only one year had significantly higher stiffness measurements compared with non-smokers. In ex-smokers, duration of smoking cessation was directly related to improvement in arterial stiffness. They found some improvement after one to 10 years, but arterial stiffness parameters only reached normal levels after more than a decade of smoking cessation.

“Our study reinforces the message that smoking cessation is an important step smokers can take to enhance the quality and length of their lives. It shows both the unhealthy effects of smoking and the benefit of smoking cessation on the arterial wall,” he said. “The longer one stops smoking the better.” However, researchers noted that results need to be confirmed in a prospective, longitudal study – one that follows patients over time.

###

Co-authors are Paula Jerrard-Dunne, M.D.; John Feely, M.D. and senior author Azra Mahmud, M.D., Ph.D.

The American Heart Association strongly supports the Family Smoking Prevention and Tobacco Control Act, bipartisan federal legislation that would give the Food and Drug Administration authority to regulate the manufacture, sale, distribution, labeling and promotion of tobacco products. The Association also advocates for smoke-free air policies, cigarette excise tax increases and comprehensive state tobacco control prevention and treatment programs. For more information, visit americanheart/fdatobacco.

Statements and conclusions of study authors that are published in the American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.

Contact: Bridgette McNeill
American Heart Association

Tobacco Smoke Has Harmful Impact On Asthma, Rhinitis And Immunity

Tobacco smoke is involved in uncontrolled asthma, a diminished response to anti-asthma drugs, rhinitis, nasal obstruction, and deregulation of the immune system according to an international expert at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.

Tobacco smoking has been mainly associated with chronic obstructive pulmonary disease (COPD), and is attributed to being one of the main reasons that COPD disease is the fourth leading cause of death in the United States.

“Recent studies have shown that smoking can be linked with other respiratory diseases such as asthma exacerbations and rhinitis,” said Carlos Baena-Cagnani, M.D., faculty of medicine, at Catholic University of Cordoba in Argentina. “Both active and passive smoking has been shown to be involved in uncontrolled asthma and associated with asthma exacerbations in children and adolescents.”

According to Dr. Baena-Cagnani, active smoking also causes changes in inflammation in asthma patients, diminishes their response to anti-asthma drugs, and has been found to induce nasal obstruction and decreased mucociliary clearance.

“The message is that smoking is a risk factor for the inception of asthma in allergic rhinitis patients, and it should be discouraged in patients with rhinitis,” he said. “There is increasing and compelling evidence that respiratory diseases, such as asthma and COPD, are also related to a deregulation of the immune system, especially the innate (natural) immunity.”

According to the latest World Health Organization statistics, currently 300 million people have asthma, and 210 million people have COPD, while millions have allergic rhinitis and other often under-diagnosed chronic respiratory diseases, Dr. Baena-Cagnani said.

“The impact of tobacco smoking is huge, with over one billion people exposed to unhealthy air in which tobacco smoking plays a major role,” he said.

Current statistics show that approximately 20 percent of U.S. adults are smokers, and more than half of them have the desire to quit according to a “Smoking Cessation Toolbox for Allergists” recently published in Annals of Allergy, Asthma & Immunology, ACAAI’s scientific journal. Surveys indicate that a physician’s advice to quit is an important motivator to quit smoking. “Screening, providing brief counseling, and prescribing first-line smoking cessation medications will help the United States get closer to achieving the national goal laid out in Healthy People 2010 of smoking rates of 12 percent or less” the investigators report.

“Allergists are aware of the significant impact that tobacco addiction has on our patients, and we are committed to initiating and reinforcing smoking cessation as part of our treatment plan,” said Richard G. Gower, M.D., an allergist/immunologist at Marycliff Allergy Specialists in Spokane, Wash., and president of ACAAI.

“We play an important role in advocating for children exposed to harmful second-hand smoke. Removing smoking as an impact factor, especially for asthma patients, improves their response to therapy and results in healthier patients.”

An allergist, an expert in the diagnosis and treatment of allergies and asthma, can perform allergy testing to identify the specific substances that trigger allergic reactions and determine the most appropriate and effective treatment.

Source
American College of Allergy, Asthma and Immunology (ACAAI)

Athletes, Spectators Faced Unprecedented Air Pollution At 2008 Olympic Games

Particulate air pollution during the 2008 Olympic Games in Beijing constantly exceeded levels considered excessive by the World Health Organization, was far worse than other recent Olympic Games, and was about 30 percent higher than has been reported by Chinese environmental experts – even though some favorable weather conditions helped reduce the problem.

The weather, in fact, turned out to be more valuable in addressing this concern than major programs by the Chinese government to heavily restrict automobile use, close factories and slow construction during and before the Olympic games.

These findings are among the final results just published in Environmental Science and Technology, a professional journal, in the first comprehensive study of particulate air pollutants in Beijing and how they compared to past Olympics.

The research was done before, during and after the 2008 Olympics by scientists from Oregon State University and Peking University, in work funded by the National Science Foundation in the United States and the National Science Foundation of China.

“Considering the massive efforts by China to reduce air pollution in and around Beijing during the Olympics, this was the largest scale atmospheric pollution experiment ever conducted,” said Staci Simonich, an OSU associate professor of environmental and molecular toxicology. “Despite all that, it was some evening rains and favorable shifts in the winds that provided the most relief from the pollution.

“This demonstrates how difficult it is to solve environmental problems on a short-term, local basis,” she added.

And despite some favorable weather and the pollution control efforts, researchers said, the end result was some of the most severe particulate pollution that Olympic athletes have dealt with in recent games. The levels were about two to four times higher than that of Los Angeles on an average day.

In some of the first comparisons of these type ever made, scientists determined that particulate matter air pollution in the Beijing Olympics were about double the levels of recent games in Athens, Greece; triple those of Atlanta, Ga.; and 3.5 times higher than the games in Sydney, Australia. However, the study also noted that, because of its control efforts, Beijing had the most significant decrease in particular air pollution compared to the other Olympic sites around the time of their games.

Despite these efforts, levels of coarse particular matter were higher than considered safe by the World Health Organization 81 percent of the time during the Beijing Olympics. They reached unacceptable levels 100 percent of the time for the most dangerous particulate matter (smaller than 2.5 microns), which is more easily inhaled into the lungs and causes more serious health problems. Levels of the smaller, most harmful particulate matter was also the least affected by government efforts to reduce pollution output, the study concluded.

The finding of levels of pollution higher than those announced previously by Chinese officials reflects a difference in measurement methodology, researchers said, although the approaches used in this study have been widely accepted for many years.

The studies were initially prompted due to traditionally high levels of air pollution in Beijing and the potential risk they posed to athletes and spectators, Simonich said. The city of 17 million people is surrounded by mountains in several directions that trap air pollutants, and has faced significant increases in particulate air pollution in recent years due to increasing industrialization, numbers of automobiles, coal and biomass burning, and other causes.

Atmospheric particulate matter, researchers say, is a concern because various sized particles have potentially toxic chemicals “sorbed” to them. The fine particles have been linked to increased respiratory morbidity and mortality. In China, particulate matter air pollution is believed to be responsible for about one million premature deaths per year, researchers said in their study.

Of some note, the scientists said, is that efforts taken to constrain air pollution may be having a lasting value – particulate matter air pollution in Beijing was as much as 27 percent lower last fall than in the same months a year earlier. Some of this, however, may have been attributable to lower levels of industrial and economic activity.

Simonich said that there is no scientific evidence so far of any health problems that have been linked to the short-term exposure of athletes or spectators to this pollution during the Olympic competition.

“The athletes and visitors were only exposed for a very short time,” Simonich said. “Millions of other people there face this air quality problem their entire lives. It was unlike anything I’ve ever seen – you could look directly at the sun and not have a problem, due to the thickness of the haze.”

Study

The research on this study was done by OSU scientists Staci Simonich and Wentao Wang in both field research and laboratory studies.

Source:
Staci Simonich
Oregon State University

National Vaccine Information Center Questions Safety Of School-Based Swine Flu Vaccine Programs

The National Vaccine Information Center (NVIC) is calling on the Obama Administration and state Governors to provide evidence that it is necessary to give experimental swine flu vaccines to children in schools and that strong mechanisms for vaccine safety screening, recording, monitoring, reporting and vaccine injury compensation are in place. NVIC announced that parental concerns about vaccine safety and vaccine mandates will be addressed Oct. 2-4, 2009 in Washington, D.C. at the Fourth International Public Conference on Vaccination.

“Parents and legislators should be asking themselves right now: Why are children the first to get experimental swine flu vaccines? Are schools equipped to get signed informed consent from parents before vaccination, keep accurate vaccination records and screen out children biologically at high risk for suffering vaccine reactions? Will people giving these vaccines know how to monitor children afterwards and immediately record, report and treat serious health problems that develop? And will states have the financial resources to compensate children who are injured?” said NVIC co-founder and president, Barbara Loe Fisher.

According to the FDA, swine flu vaccines will be tested for only a few weeks on a few hundred children and adults. NVIC is questioning whether people giving vaccines to children in schools will obey safety provisions in the federal National Childhood Vaccine Injury Act of 1986 that include:

- Giving written vaccine benefit and risk information to parents before vaccination;
- Keeping accurate vaccine records including the manufacturer’s name and lot number;
- Recording and reporting serious health problems, hospitalizations, injuries and deaths that occur following vaccination to the federal Vaccine Adverse Events Reporting System (VAERS) medalerts/

Federal Bioshield and pandemic legislation shields vaccine manufacturers and providers from all liability for injuries and deaths that occur when vaccines and drugs are administered under an Emergency Use Authorization during public health emergencies declared by government officials.

NVIC’s October 2-4, 2009 Conference will feature more than 35 scientists, doctors, bioethicists and legal experts discussing the science, policy, law and ethics of vaccination.

Source
National Vaccine Information Center

New Drug Application Submitted For Investigational Antibiotic Doripenem

Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. announced that it has submitted a New Drug
Application (NDA) to the United States Food and Drug Administration (FDA)
for doripenem, an investigational carbapenem antibiotic for the treatment
of complicated intra-abdominal and complicated urinary tract infections.
Doripenem has demonstrated activity against a wide range of Gram-positive
and Gram-negative bacteria including Pseudomonas.

Doripenem belongs to a class of antibacterial agents called
carbapenems, which are useful in treating life-threatening infections
caused by Gram-positive and resistant Gram-negative bacteria.

Pseudomonas, a Gram-negative bacterium, is one of the leading causes of
resistant hospital-acquired infections for which treatment options are
limited. The Centers for Disease Control and Prevention (CDC) and numerous
other agencies and health organizations have identified antibiotic
resistance as a serious threat to public health. The Infectious Disease
Society of America estimates that approximately 2 million people acquire
bacterial infections in U.S. hospitals each year. Of those 2 million
patients, 90,000 people die as a result. The CDC estimates that
approximately 70 percent of those fatal infections are resistant to at
least one drug.

Pending regulatory approval, doripenem will be marketed in the United
States by Ortho-McNeil, Inc. Doripenem is licensed from Shionogi & Co.,
Ltd.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
(J&JPRD) is part of Johnson & Johnson, the world’s most broad-based
producer of healthcare products. J&JPRD is headquartered in Raritan, New
Jersey (USA), and has facilities throughout Europe and the United States.
J&JPRD is leveraging drug discovery and drug development in a variety of
therapeutic areas to address unmet medical needs worldwide.

Ortho-McNeil, Inc.

Ortho-McNeil, Inc. is dedicated to providing innovative prescription
medicines to advance patient care. Headquartered in Raritan, New Jersey,
the company markets products to treat infectious diseases, gastrointestinal
disorders, and pain. For more information, visit ortho-mcneil.

(This press release contains “forward-looking statements” as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual
results could vary materially from the Company’s expectations and
projections. Risks and uncertainties include general industry conditions
and competition; economic conditions, such as interest rate and currency
exchange rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms
and governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties
and other factors can be found in Exhibit 99 of the Company’s Annual Report
on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form
10-K, as well as subsequent filings, are available online at sec or
on request from the Company. The Company does not undertake to update any
forward-looking statements as a result of new information or future events
or developments.)

For more information on Johnson & Johnson, please visit the Company’s
website at jnj.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
jnj