Tuesday, March 04, 2008

Research On Alzheimer's and Parkinson's Gains Highly Promising Results.

LEIDEN, The Netherlands, -- Top Institute Pharma presents a new and highly promising research project. The TI Pharma project is a large-scale study into the brain material of Alzheimer's and Parkinson's patients, who gave permission to the Netherlands Brain Bank for their tissue to be used for scientific research. The analysis is a continuation of highly-promising results from previous studies and focuses on the genes that could be involved in the development of Alzheimer's disease and Parkinson's disease. The study - that must form the basis for potential drugs - is one of the largest to be carried out on an international level.

The project is being realized in cooperation with Solvay Pharmaceuticals B.V., DNage B.V., the Netherlands Institute for Neuroscience, the Netherlands Brain Bank, VU University Amsterdam, VU Medical Center, the Leiden University Medical Center, Utrecht University, University Medical Center Utrecht and the Erasmus MC in Rotterdam.

It is a follow-up to previous studies carried out by two public-private partnerships: that between Solvay Pharmaceuticals, the Netherlands Brain Bank and the Netherlands Institute for Neuroscience on the one hand, and DNage and the Erasmus Medical Center on the other. The highly promising results from both studies were the reason why TI Pharma opted for a large-scale project.

Principle investigator Joost Verhaagen of the Netherlands Institute for Neuroscience: "This study is unique in several aspects. Never before has such a large-scale study been carried out into Alzheimer's disease and Parkinson's disease. Moreover, we have been able to do research on people who did not yet know they had Alzheimer's disease or in whom the disease was only just starting. We can therefore follow the very first changes due to the disease as well as its progression. And that is also unique."

Additionally, this study is using rapidly-aging mouse models from DNage, in which Alzheimer and Parkinson like symptoms spontaneously occur. Following this neurodegeneration is also an interesting part of the study. Verhaagen: "We expect that this study will also yield new insights into the development of Alzheimer's disease and Parkinson's disease and that it could therefore form the basis for potential drugs."

Daan Crommelin and Victor Nickolson, scientific director and general director of TI Pharma respectively, are pleased that the top institute has this project under its wings. "TI Pharma has successfully consolidated the available strengths: companies, knowledge institutes and universities are now working together. Thanks to this partnership research results will be obtained far more quickly. And important steps can be made towards new drugs."

Alzheimer's disease is the most prevalent variant of dementia. Two-thirds of all patients who are demented suffer from Alzheimer's disease. The disease is characterized by a progressive deterioration of the psychological functioning. Alzheimer's disease usually starts at somewhere between 70 and 80 years of age, but can also start at a much younger age. It is estimated that some 24 million people worldwide suffer from Alzheimer's disease. There are 250,000 Alzheimer's patients in the Netherlands. Over the next few decades this number will double as a result of the aging population.

Parkinson's disease mostly begins at an older age of between 50 and 60 years. However, about 10% of the patients are younger than 40 years. Parkinson's disease is mainly characterized by a progressive disruption of the locomotor system that gravely affects the daily lives of patients and can be debilitating. The disease arises as a result of nervous cells in the midbrain dying. The cause of the disease is (still) not known and therefore prevention and cure are not possible.


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Merck's Vioxx Settlement Is A Go.

Merck & Co. announced that enough people have signed on to pending $4.85 billion Vioxx settlement to keep the deal alive. More than 44,000 of the 47,000 claimants who registered injuries eligible for compensation have submitted some or all of the documentation required to seek a share of the settlement.

Vioxx was pulled from the market in 2004 when the widely used painkiller was linked to heart attacks and strokes. After a few years of fighting individual cases, a comprehensive settlement was proposed in last November.

WHITEHOUSE STATION, N.J., March 3, 2008 - Merck & Co., Inc. today said that more than 44,000 of the approximately 47,000 individuals who registered eligible injuries have submitted some or all of the materials required for enrollment that could qualify them for an interim payment in the program to resolve state and federal myocardial infarction (MI) and ischemic stroke (IS) claims filed against the Company in the United States. If all of these eligible submissions are completed in accordance with the Settlement Agreement, this would represent more than 93 percent of the eligible MI and IS claims previously registered with the program. In addition, approximately 5,000 other claimants have also sought to enroll and their eligibility status still has to be determined.

As of Feb. 29, the Claims Administrator reports more than 27,750 eligible MI claimants have initiated enrollment, more than 16,000 eligible IS claimants have initiated enrollment, more than 5,500 eligible MI and IS claimants alleging death as an injury have initiated enrollment, and more than 26,500 eligible MI and IS claimants alleging more than 12 months of use have initiated enrollment. Each of these numbers appears to represent at least 93 percent of the eligible claims in each category. These numbers do not include the additional 5,000 enrollees whose eligibility has yet to be determined.

"We are very pleased with the large number of enrollments we are seeing and are confident that when the enrollments are verified, all 85 percent thresholds will be met and exceeded within the timeframes in the agreement," said Ted Mayer, of Hughes Hubbard & Reed, one of Merck's coordinating defense counsel. "We are now working with the Claims Administrator to examine the registration and enrollment materials that have been received and continue to come in. There is a considerable amount of documentation that has to be reviewed before the definitive determination can be made that the thresholds have been met."

The timely meeting of the thresholds with enrollment documents in compliance with the Settlement Agreement would obligate Merck to pay $4.85 billion in installments into the resolution fund.

The thresholds are: (a) 85 percent or more of all eligible MI claims; (b) 85 percent or more of all eligible IS claims; (c) 85 percent or more of all eligible claims claiming death as an injury; and (d) 85 percent or more of all eligible claims alleging more than 12 months of use.

Claimants Eligible for Interim Payments
Under the Nov. 9, 2007 agreement, U.S. claimants who enroll in the resolution program by Feb. 29, are eligible to receive an interim payment, provided the claim ultimately qualifies for payment.

In recent weeks, several plaintiffs' firms reported that a substantial number of claimants who wanted to enroll needed additional time to submit complete enrollment packages. As a result, the Company and the plaintiffs' firms decided that claimants who have submitted initial submissions by Feb. 29 will receive a 31-day grace period, ending March 31, to complete their enrollment submissions with additional documentation, including properly executed releases and medical record authorization forms.

Provided the submissions are completed and verified, and participation thresholds are reached in a timely manner, those claimants will be eligible for interim payments, starting as early as August.

No Causation
Under the settlement agreement, Merck does not admit causation or fault with respect to these claims.

Merck Confirms that Eligible Claimants Can Still Enroll in Resolution Program
Eligible claimants who do not qualify for interim payments may still enroll in the resolution program if the claims were filed or tolled prior to Nov. 9, 2007 and their claims will be counted toward the participation thresholds as provided by the agreements. If participation thresholds are met in a timely manner, claimants will be able to enroll in the program through Oct. 30.

Criteria Under the Agreement
The resolution program is open only to U.S. legal residents and claimants whose alleged injury occurred in the United States.

To qualify for a payment, claimants also must satisfy three eligibility gates: 1) an injury gate requiring objective, medical proof of MI or IS (as defined in the agreement); 2) a duration gate based on documented receipt of at least 30 VIOXX pills; and 3) a proximity gate requiring receipt of pills in sufficient number and proximity to the event to support a presumption of ingestion of VIOXX within 14 days before the claimed injury.

Claimants who satisfy the eligibility gates will have their claims further evaluated by the Claims Administrator, who will make an objective evaluation of documented medical injuries and specific risk factors. This evaluation will be the basis for determining the amount to be paid to each claimant.

The Company recorded a fourth-quarter 2007 pre-tax charge in the amount of $4.85 billion to cover the cost of the agreement.

The Company will continue to defend all claims that are not included in the resolution program.

Status of Litigation
Juries had decided in favor of the Company 12 times and in plaintiffs' favor five times. One Merck verdict was set aside by the court and has not been retried. Another Merck verdict was set aside and retried, leading to one of the five plaintiff verdicts. There have been two unresolved mistrials.

As of Dec. 31, 2007, in the United States, the Company had been served or was aware that it had been named as a defendant in approximately 26,500 lawsuits, which include approximately 47,275 plaintiff groups alleging personal injuries resulting from the use of VIOXX, and in approximately 262 putative class actions alleging personal injuries and/or economic loss.


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Monday, March 03, 2008

New General Counsel For CPSC, U.S. Consumer Product Safety Commission

WASHINGTON, D.C. – The Acting Chairman of the U.S. Consumer Product Safety Commission today announced the hiring of Cheryl Falvey as the agency’s new career General Counsel effective March 3, 2008.

"Ms. Falvey is highly experienced in product safety issues," said Nord. “Her expertise will greatly benefit CPSC as it continues its work to reduce deaths and injuries associated with consumer products."

Falvey will assume her new position as a career member of the Federal Senior Executive Service (SES). The position of CPSC General Counsel had previously been a “political” (Schedule C) position, but was upgraded and changed at the initiative of the Commission.

“Making the General Counsel a career SES position will enhance the credibility and long term stability and professionalism of this very important position at the CPSC,” said Nord.

Prior to her appointment as CPSC’s new General Counsel, Falvey was a partner at the law firm Akin Gump Strauss Hauer & Feld LLP, in the Washington, DC office. She headed the firm’s litigation practice group in Washington, and advised clients on consumer product safety issues and product recalls, with a special focus on toys, children’s products, and household electronics and appliances. Falvey joined Akin Gump in 1990 after several years of practice with a New York law firm.

“I am extremely pleased to join the U.S. Consumer Product Safety Commission,” said Falvey. “I look forward to working with the CPSC’s talented staff to assist them with their mission to protect children and families against consumer product hazards.”

Falvey received her B.A. from Wellesley College in 1984. She received her J.D. from the Georgetown University Law Center in 1987 and served as editor of the American Criminal Law Review while at Georgetown. She is a member of the Virginia, New York, and District of Columbia Bars.



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Talking Parents (About Sex), Leads To Healthy Teens!

Recent study conducted by a group of scientists and supported by National Institute of Mental Health and Centers for Disease Control, suggests that speaking to children regularly about sex may keep them from involving in risky sexual behaviors.
The study
included 312 teens and their parents. All participants were given baseline questionnaire and the teens were assured that their parents would not see their answers. The parents were then divided into two groups. Half of the parents were sent home without giving any further instructions. The other half attended an eight-week worksite-based parenting intervention class called "Talking Parents, Healthy Teens," designed to ease parent teen communication in difficult subject matters like sex.

There were Follow-up surveys conducted at intervals of one week, three months and nine months. The surveys assessed 22 sex-related topics, such as "how you will make decisions about whether to have sex,", "consequences of [getting pregnant/getting someone pregnant],""how to choose a method of birth control," "what it feels like to have sex," "how well condoms can prevent sexually transmitted diseases," and "how to say no if someone wants to have sex and you don't want to" and more.

At each follow-up survey, adolescents were presented with the same list of 22 topics and asked to report whether they had discussed each topic with their mother or father since the last survey. This helped researchers to assess how the parent teen communications were conducted.

They found that when teens and their parents had more conversations, often, teens reported feeling closer to their parents. This made them feel that they could talk more openly with their parents about sex or any other topic for that matter. A greater breadth of communication was associated with a perceived ease of discussing sex between parent and child, according to the study. But opening up and communicating closely with your children may also give you similar results. I had two good friends, infact they were my best friends, my parents. (I never got anyone pregnant, nor got infected with any sexually transmitted diseases. Basically I am a happy individual and I owe a lot to my parents for that.

Following is ths abstract of the study and the complete paper could be read at the pediatrics, a link to which is provided at the end of this article.


OBJECTIVE. Most studies of parent-adolescent communication about sexuality focus on the frequency of communication without distinguishing between the breadth of topics covered and repetition. The goal of this study was to assess the independent influence of breadth and repetition of sexual discussion on adolescents' perceptions of their relationship and communication with their parents.

METHODS. Data came from 312 adolescents who, along with their parents, were control participants in a randomized, controlled trial to evaluate a worksite-based intervention designed to improve parent-adolescent sexual communication. Adolescents completed surveys before the intervention (time 1) and at 1 week, 3 months, and 9 months after the intervention (times 2, 3, and 4, respectively). At each survey, adolescents reported whether they had discussed each of 22 sex-related topics with their parent. Breadth was defined as the number of topics discussed for the first time between times 1 and 4, and repetition was defined as the number of previously discussed topics repeated during that period.

RESULTS. Adolescents whose sexual communication with their parents involved more repetition felt closer to their parents, felt more able to communicate with their parents in general and about sex specifically, and perceived that discussions with their parents about sex occurred with greater openness than did adolescents whose sexual communication with their parents included less repetition. Breadth of communication was associated only with the perceived ease of parent-adolescent sexual communication: adolescents who discussed more new topics with their parents between times 1 and 4 felt that their sexual discussions occurred with greater openness than did adolescents who discussed fewer topics.

CONCLUSIONS. Clinicians may want to advise parents about the value of discussing sexual topics repeatedly with their children, because this may provide parents an opportunity to reinforce and build on what they have taught their children and provide children the opportunity to ask clarifying questions as they attempt to put their parents' sexual education into practice.
Pediatrics paper on Beyond the "Big Talk": The Roles of Breadth and Repetition in Parent-Adolescent Communication About Sexual Topics.
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Children who start the day with a healthy breakfast stay trimmer

According to statistical data, the rate the obesity in children is increasing alarmingly. I my self have packed a few extra pounds although I am not a child nor teenager. Just read the following data from CDC, U.S. Centers for Disease Control and Prevention. But still there is hope, Just having a healthy breakfast may prevent a child from getting obese. Follow the link at the end to research paper published on Pediatrics to get complete information.

"The prevalence of overweight among children aged 6 to 11 more than doubled in the past 20 years, going from 7% in 1980 to 18.8% in 2004. The rate among adolescents aged 12 to 19 more than tripled, increasing from 5% to 17.1%."

The March 2008 issue of Pediatrics has an research paper on how breakfast affects the weight control in adolescents.
Project EAT (Eating Among Teens), a 5-year longitudinal study, was developed to examine eating patterns and weight concerns among adolescents. The purpose of the present study was to examine the association between breakfast frequency and relative body weight in both cross-sectional and prospective (5-year body weight change) analyses in adolescent males and females. We hypothesized that breakfast frequency would have an inverse association with body weight and with weight gain. Examining this question across both cross-sectional and prospective analyses allowed us to evaluate the robustness of the findings and to make comparison with the different study designs in the literature. We also examined the correlates of breakfast frequency, including demographic, dietary, and psychosocial (weight-related) factors that may be confounders or mediators of any breakfast–weight change association.
The results were pointing that if you have breakfast regularly, that may lead to weight control;
" At time 1, the greatest percentage of study participants ate breakfast intermittently (56.5% and 49.1%, girls and boys, respectively; Table 1). Those individuals who never ate breakfast were more likely to be girls (16.4%) than boys (13.0%; P = .03), whereas those who ate breakfast daily were more likely to be boys (37.9%) than girls (27.2%; P < .0001). The greatest change over time was observed in boys, where there was a 16.8% decrease from time 1 to time 2 in the participants who ate breakfast daily, such that at time 2 there was no difference in the prevalence of daily breakfast by gender (P = .96)."

As rates of breakfast consumption decrease throughout adolescence and into adulthood, the impact of regular breakfast consumption on public health may be significant. More emphasis should be placed on breakfast habits, especially among adolescents and young adults, when behavioral patterns are developing and stabilizing. One venue that may be appropriate for interventions is the school setting. Interventions should be aimed at promoting a healthful breakfast (eg, whole grain cereals, low-fat milk, and fresh fruit), because diets including nutrient- and fiber-rich carbohydrates have been shown to lead to weight loss and reduce disease risk. Interventions could promote the ease and practicality of the breakfast meal, which can be eaten at home, school, or work. Long-term studies including these types of interventions will be needed to evaluate the possibility of an important causal link between breakfast consumption and risk for obesity and chronic diseases, as well as for implementing generalizable community-based programs.
Children who start the day with a healthy breakfast stay trimmer.

Pediatrics article on child obesity control with healthy breakfast.

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Saturday, March 01, 2008

Frozen Fish, Crispy Battered Fish Fillets Recalled By Gorton’s

The affected Battered Fish Fillet products have a UPC code of 44400 - 15770, a “Best if Used by Date” of April, 2009, and the following manufacturing code that is embossed on the side of the package:

7289G1

For reference, this manufacturing code is indented into the long thin side panel of the box. The product being recalled is only the 11.4 oz. package, containing six Battered Fish Fillets with this specific manufacturing code. No other Gorton’s products are being recalled.
Recallr: Gorton’s recall Frozen Fish, Crispy Battered Fish Fillets,
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Recallr: Two USDA Inspectors on Leave Over Beef Recall

Two inspectors involved in the largest beef recall in history. The USDA recalled 143 million pounds of beef from Westland/Hallmark Meat Co.'s plant in Chino, after the Humane Society released undercover video showing workers shoving sick or crippled cows with forklifts to get them to stand.
Recallr: Two USDA Inspectors on Leave Over Beef Recall

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