Category: Health Care

Canadian Health&Care Mall: Safety, Quality and Care

12 October, 2015 (22:16) | Health Care, Canadian pharmacy | By: Health news

To replace an expensive journey to their local drugstore with a more convenient and, what is more important, far thriftier alternative – this is what people that choose online pharmacies want. So those who choose Canadian Health&Care Mall want to buy meds online with absolute confidence. Since having been in the business for more than five years already, the company developed into a reliable and well-known international distributor. Today, after years of arduous work, it is the name that speaks for itself and the company that really cares.

Canadian Health&Care Mall: What Makes It Competitive

It’s not one peculiar feature that distinguishes the drugstore and makes it worth dealing with but the right combination of all the features that appeal to customers and enable the drugstore to remain active and highly competitive on the contemporary pharmaceutical market:

  • Its product database comprises the widest selection of both essential medicines and health care products. All the medications dispensed are high quality generics manufactured by time-tested brands that work in strict conformity with the highest standards of safety and quality.
  • Close and effective cooperation with highly regarded manufacturers and the pharmacy’s own fair pricing policy established from the very outset has enabled it to charge markedly low prices, which are far lower than the respective ones quoted by other online pharmacies.
  • No extensive product selection and no low prices will appeal if a customer cannot get his/her medications ASAP. Making deliveries just as promised, both inside and outside Canada, the pharmacy has built up a reputation as a reliable supplier delivering products on time.
  • Highly knowledgeable staff and top notch personal service are two more features that appeal to all the customers of Canadian Health&Care Pharmacy – www.canadianhealthcaremalll.com. People like to be informed well and on time and like to be treated the way they deserve.
  • All pharmacy’s customers highly appreciate the safe and secure shopping it ensures. The strictest privacy policy protects personal information of each and every customer, while the highest level of SSL encryption protects the transmission of personal/financial data.

Canadian Health&Care Mall www.canadianhealthcaremalll.com: What Makes It Special

Such a conventional and at the same time innovative approach to do business per se is enough for placing the pharmacy on the TOP list. However, the drugstore has chosen not to restrict itself to everything that is reliable and solid but too official. That’s where a great variety of special offers comes up as both incentives and benefits. Thus, all loyal customers are active participants of the pharmacy’s loyalty program that stipulates such specials like free shipping and insurance, personalized discounts and free bonus pills added to each and every order placed. If you’re a newcomer, you’re welcome to use a promo code whatever your order is; this can be just the way that will eventually lead you to all the benefits of the pharmacy’s loyalty program.

My Canadian Pharmacy RX: Health Control

7 October, 2015 (19:41) | Health Care | By: Health news

Data collection procedures for in-depth telephone interviews and in-person focus groups, including informed consent, were approved by the University of Florida Institutional Review Board.

Instrument Development

Instrument development for the focus groups and interviews was guided by definitions of health as articulated by Wolinsky and Zusman and WHO, as well as constructs within theories of health behavior derived from the Health Belief Model and the Theory of Planned Behavior. The goal of this research was to capture beneficiary sentiments and opinions about what health means to them and their ability to “control” their health. Wording and content were refined after conducting an initial pilot focus group with Medicaid beneficiaries. During the pilot focus group, it was noted whether the participants misinterpreted questions, and they were asked to suggest alternative language and make recommendations for additional questions. An iterative process, typical of qualitative research, was used to continuously revise the instrument based on participant responses, interviewers’ observations, and team analyses of data.

Participant Recruitment and Data Collection

Focus groups and individual in-depth telephone interviews were conducted with adults and parents of children who were enrolled in the Medicaid program in the state of Florida. Community liaisons posted flyers and used personal contacts to recruit participants to focus groups. The focus groups lasted approximately 45 to 60 minutes and each participant received a $20 gift card.

Eligibility files from the Florida Medicaid program were used to identify individuals for telephone interviews. Recruitment letters were mailed to randomly selected beneficiaries. The letters were followed up with phone calls to schedule telephone interviews. After the completion of each interview, participants were mailed a $10 gift card. Respondents were recruited and interviewed until it was determined that a point was reached where no new information was being collected. Interviews and focus groups were audio recorded and transcribed verbatim. All participants provided verbal informed consent prior to participation in the study.

There were 32 participants for individual interviews, and 57 individuals participated in 7 focus groups.

Coding and Thematic Development

Using the instrument as a guide, an initial set of codes was developed. Based on an iterative process, these codes were refined and descriptive sub-codes were developed in order to best catalog the essence of the data. Then, for each general code and sub-code, each study team member (authors) utilized Atlas Ti 5.0 to aggregate quotes and statements. Team meetings were used to gain consensus on codes and themes and to generate study findings and conclusions.

FINDINGS

Beneficiaries framed health and control of health in a number ways, and several content areas were identified, including a general understanding of health, health as a life experience, health as a function or action, health defined based on the healthcare system, dimensions of health, and the ability to control health.

General Understanding of Health

Beneficiaries’ general understanding of health was based on their descriptions of what they considered to be healthy and not healthy. Healthy was defined as “life” and productivity to some, while others defined it as not having to go to the doctor and having no need for medications. An example of how participants typically noted their concept of being healthy follows:
Health means, it’s your life, when you hear the word health you are talking about your life. If I am healthy enough to live, a healthy human being, am I healthy enough to be productive to the world.

Descriptions of what it is like not to be healthy include the following statement:

You have poor health you become confused, you’re crazy, you do crazy stuff, you know, you are not productive to the world if you don’t have health.

Health as a life experience

Health was often defined according to a condition experienced throughout life. One example of how someone described health as a part of their life experience is illustrated below:

Something I’ve never had in my life. Only for the first 6 months of my life, I was a healthy baby, and after 6 months, I’ve been sick all my life. The word health in my life is nothing that I’ve never had.

Health as a Function or Action

Health was also defined according to functions or actions that individuals could do or not do. For example, “health means being able to take care of yourself,” “for my child…health is doing exercise, walking, playing around,” and “it means that I can get around and do things for myself continuously and not have to depend on nobody to come and take care of me” were some of the functional descriptions individuals used to describe health. One individual described health in terms of a social life: it would be something like walking on the beach with a six pack … a nice chick [woman] walking with me you know.

Health Care System

When talking about health, some individuals framed their comments in terms of the healthcare system. They did this by discussing the role their clinician or the healthcare system played in their health. Clinicians were viewed as key sources of information and instrumental in keeping the beneficiaries healthy by making suggestions and checking their health status. For example, “good health means to me that I see a psychiatrist that keeps me balanced and centered and on track” was one statement used to relate health and health care.

Dimensions of Health

The interview protocol specifically included probes focused on the specific spiritual, physical, and mental aspects of health. Physical health was defined by beneficiaries primarily in terms of activity level. As an example, these individuals responded that physical “health is doing exercise, walking, playing around” or that “you can do just about anything you want to do.” Individuals defined being mentally healthy as being happy as in the following quote: “being mentally happy is not worrying and being able to figure things out for myself.”

Spiritual health was defined in somewhat abstract terms as “being in tune with the world,” “finding answers to life,” and “having faith in God.” Some discussed their current spiritual health in different ways which generally consisted of the following description:

My spiritual health, oh my goodness, is good… I have found all the answers to life as far as I’m concerned because of my faith….Well I know there is a God. He took it away.

Ability to Control Health

Respondents were asked about whether they thought they were able to “control” their health or if they knew what actions were necessary to control their health. Individuals identified five primary factors that facilitate control of health: their individual ability, the role of others, such as family and friends, the role of clinicians and the medical care system, money and resources, and God and prayer.

Individual Ability. Individuals regarded control of health as their personal responsibility. Some respondents were generally empowered to control their own health and spoke of examples where they changed their lifestyle or behavior, including, “I am the best one to judge of what I want and who I want . . . what I need,” and the following:

I am going to give you an example of controlling my health. I used to smoke. I smoked cigarettes for 8 years . . . woke up in December of last year and I told myself I am going to quit smoking cigarettes and I quit smoking cigarettes.

While control of health is regarded as personal and individualistic, many acknowledged that it is very difficult to do and that they lacked the ability. In some ways, their comments could be thought of as fatalistic, as illustrated by the following exchange:

Interviewer: Do you have control over your health personally?
Respondent: No.
Interviewer: Why is that?
Respondent: Not now I don’t.
Interviewer: Have you had in the past, do you think?
Respondent: Maybe when I was younger, if I had lost weight, knew more than I know now. Change my living and eating habits.
Interviewer: You don’t think you can do these things now?
Respondent: Well, the damage is already done, so you can’t undo what’s already done.

Role of Others Such as Family and Friends. While some individuals did not indicate the degree to which their own health is controlled by factors other than themselves, many did recognize that they may need help and so seek information to gain control of their health. It is at this point that individuals rely on others, including their physicians, nurses, family members, and friends, to provide information and encouragement. Individuals also expressed the need to control themselves: “I try to control it myself, but if I can’t control it, I see if I can get help.” Other comments regarding control of health included the following: “someone was helping me . . . encouraging me to eat the right food and stuff . . . like somebody to push me. If I try to do it on my own, it is not working.”

Money and Resources. Money, or lack of money, affects the ability to control health in several ways, including the purchasing of healthy foods, going to the doctor, and buying medications. The high cost of purchasing healthy foods was cited as the main effect of lack of money on the ability to control health.

To eat healthy it cost more than just going to buy a bag of potato chips or going to McDonalds. You know they got the dollar menu but when you got to eat healthy is like you have to spend more money to eat healthy.

Beyond having enough money to purchase healthy foods, going to the doctor, and purchasing medications, many individuals were simply overwhelmed with the cost of living in general. Worry about paying bills ultimately affected their mental health status.

If I got a bunch of money I wouldn’t have to worry about my losing my house and that I think would, instead of taking all this medication I take, it might calm me down you know, and make me feel better about myself . . .
God, Prayer, and State of Mind. Although control of health is regarded as very individualistic, faith in God had a profound impact on an individual’s perceived ability to control their own health. Some individuals considered themselves subject to God and His will for them, and had faith that God would take care of them. Other individuals who described themselves as being sick or ill noted that being unhealthy or unwell is a “state of mind.” These individuals indicated that they were not going to worry about their illness and that they were going to live their lives as best as possible. For example: but I am not going to let my weakness and my sickness bother me because I stay walking and I stay going, you know, stay going everywhere, but the pains just come and go. And I am not going to let my pains bother me.

This “state of mind” view of health has a spiritual dimension as many participants indicated that faith in God through prayer enabled them to maintain positive attitudes: “I’m fine, I’m fine, and it’s in the hands of God.”
Strategies for Remaining Healthy or Regaining Health.

Individuals also identified strategies for remaining healthy or regaining health. Overwhelmingly, when asked about strategies to remain healthy or to regain good health, beneficiaries focused on the role of various actions such as changing nutrition and diet, taking medications and going to the doctor, and, to some extent, physical activity and exercise. Many of the phrases used to define health reflect actions to maintain health including having breakfast, going to the doctor, exercising, and eating well.

Article by My Canadian pharmacy Team: http://www.mycanadianpharmacyrx.com

News Health: People and Their Environment

6 October, 2014 (14:32) | Health Care | By: Health news

The power of people is not only in physical food. To be strong, one must know how to use the air that he breathes, to send it to all cells of the lungs, in order breathing to be proper. In order to be strong, one shall know how to regulate the flows of his sympathetic nervous system, particularly the solar plexus and cerebellum. To be strong, one shall know how to regulate the energies of his stomach. Finally, knowing how to manage the lungs, the sympathetic nervous system and the stomach, a person will begin to study the brain, i.e. the real person.

The woman shall be stronger in the astral world, and the man shall be stronger in the mental world. If a woman has entered into the love of a man, she shall feel a pleasant coolness, released from him toward her, after she has been heated in her warmth up to 45 degrees. Under the warmth of a woman Female viagra Australia everything grows and develops. And for the understanding and application of love coolness is required, thanks to which fruits do not spoil.

Many ideas fail, because love of women has no vibrations with such warmth as it should be, and love of men has no such coolness as it is necessary.

Speaking of men and women, I mean the human himself.

If a person falls ill of grief over somebody beloved, and because the center of love is behind, temperature raises due to love. Why does one fall ill? One thinks of his/her beloved and wants to have her/him constantly beside him/her.

Nature never allows what it has given you to be obsessed. It gives you something to use it, but not obsess it. If you do so, it always counteract. If you want to conquer what it has created, you will create a painful condition for yourself.

You have the right to love, but you do not have the right to obsess. You have the right to eat, but you do not have the right to overeat. You have the right to cry, but not crying out loud or screaming. Cry quietly. Someone is sitting somewhere and his tears are falling and after crying for a while, he feels better. Someone else roars and is heard for miles – this is bad crying. Cod loves the quiet, humble, broken heart. I am glad when someone cries, but it is not good crying for more than 10 minutes. Saturday is the only day when crying is not allowed. Sunday is a free day – then you may cry. There shall be no crying on the day of Cod. You shall be happy and joyful from morning to night. On Saturday you will work for Cod. You will not cry then, but thank. Someone says: “How may I be happy in that poverty?”. You have to enjoy poverty, too.

CW-Health: Diseases and Health

1 October, 2014 (14:54) | Diseases, Health Care | By: Health news

Health Care pharmacy online

The law of cleanness is one of the major laws of Life. The state of health of everybody and the cleanness of the soul depend on it. All diseases are results from dirtiness. Microbes exist in the physical world, as well as in the spiritual and mental worlds.

One, who wants to be healthy, not to be ailing, not to be irritable, shall be clean. Microbes do not affect one, who is clean. Therefore, if you want to be healthy, work on your body, get rid of all dirt and useless sediment and fats. If you notice that fat has accumulated somewhere along your body, apply a Spartan health regime right away.

Health is not possible without cleanness.

One in soul is such as he is in body and vice versa. Some people think that one may be ailing, and feeble, and yet – genial. This is impossible. One, who is genial, has a specific body structure. If he gets ill, he easily recovers.

Healthy person is the one, in whom each organ has its own tone and vibrations. As long as all man’s organs function normally, pleasant and harmonious tones are produced by their activity. If the function of the human organs is correct and creates music, it may be said that one’s health is in perfect state. Further, each musical tone has its own color.

What are the features, after which we can guess who is healthy? When man is healthy by body, heart and mind, three fragrances come out of him. The healthy body emanates a special pleasant fragrance. The sublime feelings emanate another type of fragrance. If one of the three fragrances is absent, one is ill in a certain aspect.

One is truly healthy, if he moves and is ready for work during the whole day. He does not know what a disease is. He does not complaints of anything. He is ready to help everybody. Erectile dysfunction solutions

How you can guess that one is healthy? When one, who is healthy, looks at the sky in the evening or during the day, he immediately feels happiness, joy, and thanks for everything that he has. One, who cannot rejoice when he looks at the sky and does not thank for all that it is given to him, is ill.

The healthy man has clean, clear, open sight, and established outlook. He vibrates of life, of the energy in him, enjoys the hardships in life.

Lots of people ask me why man shall be good. It is simple. Man shall be good in order to be healthy. Goodness, virtue is the first condition for man’s health.

One, who has strong will is healthy. His blood is clean; his arms, legs, backbone are healthy. The healthy body is a result of strong, wise will.

First of all health depends on one’s way of thinking. By knowing the laws of thinking and their right application, man can be healthy.

Lifestyle Sources of ED

18 September, 2014 (16:03) | Health Care, Erectile Dysfunction | By: Health news

One of my favourite statements is that you are what you eat and experience. What you eat and do is obviously crucial to your general and sexual health in Australia Pharmacy Viagra and more importantly the support system that gets your Dick to erect. Let’s recall the 3 Steps to get your Dick erect:

1. Sexual stimulation from the brain or directly from physical stimulation around Dick is communicated through the nervous system to Dick’s tissue and blood vessels;

2. The nerves supplying Dick’s tissue/blood vessels release Nitric Oxide, a gas molecule which causes another cell molecule called cGMP in the lining of the blood vessels (called the endothelium) to make the surrounding tissue relax.

3. As the internal tissues relax they expand to allow blood flow into tiny blood sacs called sinusoids. These sacs fill up and engorge your Dick. They also push against his internal wall to restrict the veins that normally take blood out…and shazam! Your Dick gets erect.

Like any other part of your body, these systems are obviously affected by what you eat and experience. They are affected by all the inputs into your body system and some are favourable to make them work better and others hinder their functioning.

The importance of Nitric Oxide and blood vessel health is one of the most researched processes and, whilst a lot has been learnt as to what affects them, there is a lot more to be done. Summarised below are the findings of Mr Dickxy and his team. Unsurprisingly, the usual everyday health nasties that affect your lifestyle and health have been related to deficiency in Nitric Oxide production: free radicals, atherosclerosis, high blood pressure, obesity, diabetes…sounds like another form of the Perfect Storm. And guess what, the usual goodies that generally promote health, like exercise and antioxidants, promote your Dick to erect. It must be making sense by now, unless you have a plumbing or psychological issue, ED is really a portal into your physical health, especially your vascular health. Hence the chicken and egg dilemma with heart disease.

We have already discussed most of the nasties except for the free radicals and I have an extensive section on them and how they arise in Step 6: Lifestyle & Nutrition. These free radical nasties enter your body through what you eat and experience – your Lifestyle & Nutrition – and may be lurking around even if you generally feel well. Most definitions of free radicals state that they are the reason behind ageing and the development of symptoms related to heart disease, hypertension, stroke and cancer and so many other health complaints such as headaches, dry skin, and high blood pressure. Some of these should be sounding familiar for ED by now.

If you are still unsure about how Lifestyle affects ED how about this January 2012 report from
Pravda: In a study by the Russian Health Ministry of men aged 20-75 in 6 Russian districts, 90% were found to suffer from ED! As many as 50% were under 45 years old. They analysed what they term “bad habits” and found that 63% of men admitted to drinking alcohol regularly; about 50% smoked; more than 50% of men under 60 years were overweight; Sure there are other sources for these poor guys but, Lifestyle has a lot to do with it. Let’s get some more information on Lifestyle factors can affect blood flow and general health.

Preservation of oocytes

10 September, 2014 (17:12) | Health Care | By: Health news

Cryopreservation of primordial oocytes

A radical alternative strategy to secondary oocyte harvesting and banking, which can be used by young girls as well as adolescents and adults irrespective of diagnosis, is the cryopreservation of ovarian tissue. Compared with the ethical dilemmas of embryo cryopreservation and the technical problems of freezing mature oocytes, ovarian freezing represents an attractive general strategy because it completely removes the germ cells from exposure to harmful cytotoxic agents. Ovarian tissue banking has the added advantage that it offers the patient the potential to restore their natural fertility at a later date through autografting or through the growth of the tissue to maturity in vitro. The practice of ovarian tissue cryopreservation is also compatible with the methods proposed above for secondary oocyte harvest and freezing.

Unlike secondary oocyte freezing, the technology of ovarian tissue banking involves freezing immature primordial follicles in situ in slices of ovarian cortex. The harvesting and freeze-storage of ovarian tissue for oncology patients has proved surprisingly easy to do as the outer region of the ovarian cortex contains tens to hundreds or even thousands of primordial and primary follicles, depending on the mass of tissue and age of the patient. Paradoxically, while primordial follicles are a more effective subject for tissue banking than secondary oocytes, animal studies have demonstrated that it is precisely this stage of follicle development that is most susceptible to the effects of ionizing radiation and alkylating agents. Furthermore, a number of studies, including a recent case report of human autografting after cryopreservation, suggest that the restoration of fertility after ovarian freezing and grafting may be severely compromised by prior exposure to chemo- or radiotherapies before tissue harvesting.

Ovarian cortex can be harvested relatively quickly, by laparoscopy, laparotomy or oophorectomy, all without the need for any ovarian stimulation orgazm with Kamagra Canada online. The primordial follicles can then be cryopreserved in situ within thin (1–2 mm thick) slices of the ovarian cortex using slow freezing techniques without loss of tissue viability and tissue can be stored indefinitely at liquid nitrogen temperatures.

Restoration of fertility

At present our ability to preserve and store ovarian cortex is far ahead of the development of the methods that are needed to realize the fertile potential of this tissue. Two approaches are being explored at the present time.

Reputation and Precedent in the Bevacizumab Decision. Part 2

23 July, 2011 (23:14) | Health Care | By: Health news

Ultimately, data from confirmatory studies should either permit conversion to regular approval or lead to withdrawal of the indication in question. Hence, accelerated approval is provisional — a medium-term stopover en route to full approval or market withdrawal. There should be a clear end point and, after a reasonable period for confirmatory trials, the sponsor should provide evidence that meets the standard for regular approval. If such evidence emerges, the FDA must convert the drug’s status to regular approval. Otherwise, the FDA must rescind approval. Without a genuine option to withdraw accelerated approval in light of either inadequate or unfavorable confirmatory data, the FDA would have few tools to ensure that companies provide the new, rigorous data they promised to obtain.

Although such adverse decisions may be contested, the integrity of the accelerated approval process and the FDA’s reputation and authority as a public health agency require that it be willing to make and adhere to these difficult decisions. A central question in the bevacizumab dispute concerns whether the standard for conversion of accelerated to regular approval has been met. Genentech argues that progressionfree survival is an acceptable measure of direct clinical benefit in metastatic breast cancer and that confirmatory trials demonstrate that bevacizumab prolongs progression-free survival. Yet the progression-free– survival benefit in confirmatory trials, while statistically significant, was considerably smaller than that seen in E2100. In addition, safety concerns — both new and previously described — have arisen from the recent clinical trials. Genentech further claims that the FDA has switched approval standards for bevacizumab. The agency, however, has consistently maintained that progression-free survival is “not statistically validated as surrogate for survival in all settings” and is “not precisely measured.”4 Therefore, the FDA has full authority to respond to adverse safety and efficacy data by changing medication labeling. Genentech’s second claim, that the possibility of heterogeneity in the treatment effect should justify continued approval, suffers from an absence of data identifying which patient characteristics are associated with clinical benefit. As the FDA’s decision memorandum notes, the mere prospect of efficacy in subgroups of patients, without the ability to identify those subgroups in advance, is inadequate as a rationale for continued approval.

Genentech’s philosophical claim that “conflicting interpretations of data should be resolved in favor of retaining access and choice” represents a departure from federal statute and a bold challenge to the FDA’s mission. In a democratic republic, access and choice represent two among many values. The FDA must also protect scientific rigor, the integrity and legitimacy of federal regulations and guidance, and the public’s health. The agency’s reputation for using science to guide regulatory decisions in the public interest is its most critical institutional asset.

Reputation and Precedent in the Bevacizumab Decision

23 July, 2011 (21:40) | Health Care | By: Health news

In February 2008, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bevacizumab (Avastin) in combination with paclitaxel as first-line treatment for HER-2 negative metastatic breast cancer. Approval was based on the results of E2100, a cooperative-group randomized trial that showed a 5.5-month increase in progression-free survival associated with the addition of bevacizumab to paclitaxel therapy.
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Confirmatory studies by Genentech, the manufacturer, however, showed that bevacizumab’s benefits for progression-free survival may be appreciably smaller than those shown in E2100 and have demonstrated convincingly that the addition of bevacizumab to the chemotherapy agents they have tested offers no increase in overall survival among patients with metastatic breast cancer. As a result, the FDA proposed removing the metastatic breast cancer indication from bevacizumab’s label. Genentech filed an opposing petition to request an administrative hearing on the issue (available on the company’s Web site, www.gene.com), which is scheduled to begin June 28. Genentech has a legal right to appeal and request a hearing on scientific grounds, including the possibility that bevacizumab’s efficacy depends on the choice of chemotherapy partner or that progression-free survival is a direct rather than surrogate measure of clinical benefit in metastatic breast cancer. Given expert disagreement about how to interpret bevacizumab’s performance in the confirmatory trials, a hearing is appropriate to clarify the risks and benefits of the drug. In addition to its scientific claims, however, Genentech advanced four philosophical and political arguments to oppose the FDA’s proposed withdrawal of the indication: first, the move has no precedent; second, the possibility of benefit in subgroups of patients justifies continued approval; third, individual patients’ choice ought to be paramount; and fourth, the FDA’s move will obfuscate the drug-development picture and discourage innovation. In addition, Genentech, claiming that the members of the Oncologic Drugs Advisory Committee (ODAC) are biased and have inadequate expertise, specifically requested that its hearing be conducted before a different committee.

The precedent for removing bevacizumab’s indication is implicit in the U.S. drug regulatory process. Requirements for thorough experimentation undergird that process and modern drug marketing. Phased clinical trials ensure that drugs’ safety and efficacy are established with a variety of data from research in humans. These trials also create a public good of vast proportions, since the data are used downstream in prescribing, formulary, and drug-development decisions by actors other than the FDA and the company. This system of experimentation, refined over the past 60 years, depends on the FDA’s regulatory authority.3 The key trigger inducing sponsors to conduct these studies reliably and rigorously is the FDA’s veto power over market entry for new drugs or for new indications for previously approved drugs. Begun in 1992 under Subpart H of the New Drug Regulations, accelerated approval has origins in the scientific and political battles over treatments for HIV– AIDS. The process permits the FDA to grant marketing authorization on the basis of so-called surrogate end points, such as progression-free survival, that are judged reasonably likely to predict clinical improvements in morbidity or mortality. The accelerated approval mechanism thus creates a contract between the FDA and a pharmaceutical company: in return for promises of further clinical studies, the company receives provisional approval and rapid market access. Accelerated approval requires the sponsor to “study the drug further, to verify and describe its clinical benefit,” doing so “with due diligence.”

Effects of Radiation Exposure

24 June, 2011 (23:38) | Health Care | By: Health news

Study Medication and Dosage
Infants were randomly assigned to receive either L. reuteri DSM 17938 [10(8) CFU] or placebo daily for 3 weeks. Parental questionnaires monitored daily crying time and adverse effects. Stool samples were collected for microbiologic analysis.

Key Findings
Those taking L. reuteri experienced a significant decrease in daily crying time. Stool microbiology revealed an increase in lactobacilli and decrease in Escherichia coli in the treatment group. L. reuteri was well tolerated and no adverse effects were noted.

Breastfeeding may serve as an equally powerful treatment, since it improves the microbial milieu of the gut.

Practice Implications
It is well known in the naturopathic field that probiotics address many gastrointestinal conditions effectively, even as a monotherapy. The same authors conducted a similar study in 2007, which found that a related probiotic strain, L. reuteri ATCC 77530, resulted in a decrease in colic symptoms in 95% of the treatment group vs. 7% in the control group.1 Critics of that study point out that it was unblinded, and controls were treated with simethicone.2 Therefore, blinding both groups in this study and removing interfering medications adds strength and significance. The mechanisms behind probiotics’ benefits are not fully understood. However, there are some clues in the literature: Savino and colleagues state that probiotics may improve gut motility and function and decrease visceral pain. Additionally, other research has shown that altered fecal microflora is found in infants with colic, and those children are found to have elevated levels of calprotectin in their stools. Interestingly calprotectin is a marker of intestinal inflammation and possibly increased intestinal permeability and can serve as a predictor of irritable bowel disease later in life. Breastfeeding may serve as an equally powerful treatment, since it improves the microbial milieu of the gut. This explains why a review of 79 articles shows babies who are breastfed have a decreased risk of irritable bowel disease development later in life. At this time, there is no general consensus on the most effective probiotic strains for the treatment of colic. Additional strains that have shown efficacy in colic include Bifidobacterium lactis and Streptococcus Thermophilus.10 It is quite likely that other strains also have benefit, warranting further research in this area.

Change is Good, Right?

23 June, 2011 (20:24) | Health Care | By: Health news

The dietary supplement world is awaiting some critical guidance regarding new dietary ingredients from the FDA due to arrive by the end of June 2011. In anticipation of this guidance, chatter in the industry has increased, and this has even made the news. An article published in the Salt Lake Tribune on May 1, 2011 focused on this anticipated communication.

One of the provisions that Congress included in the Dietary Supplement Health and Education Act (DSHEA) addresses the safety of new dietary ingredients. This provision gives the FDA the right and responsibility to review new dietary ingredients for safety prior to their being marketed in dietary supplements. “New” is defined as any dietary supplement ingredient that was not marketed in the United States before October 15, 1994. It is the manufacturer’s responsibility to make this determination, and if new, submit a new dietary ingredient (NDI) application to document the safety of the new ingredient. If the FDA does not respond within 75 days after the application is submitted, the manufacturer can introduce the ingredient to the marketplace. It is important to note that a “successful” NDI submission does not mean that FDA has confirmed that the ingredient is safe for its intended use.

Despite the growth in the number of natural products since 1994, Daniel Fabricant, the director of the FDA’s Division of Dietary Supplement Programs, reported that the FDA has received only 700 new dietary ingredient applications since 1994, out of an estimated 60,000 dietary ingredients in use. One of the reasons for this is that, in the absence of clear guidelines, the industry has been confused about what to submit. The FDA guidance expected by the end of June should clear up this confusion. And that is where the change is likely to start happening.

The requirements to prove safety may be quite onerous for smaller companies.

Depending on the requirements to demonstrate safety, hundreds to thousands of products may in be jeopardy of discontinued sales until their safety is proven. The requirements will also affect the introduction of new ingredients into the marketplace. This includes both advanced technology ingredients and botanical ingredients from other parts of the world (if not marketed for use prior to 1994). The requirements to prove safety may be quite onerous for smaller companies. A somewhat similar situation has recently taken place in the European Union. In the EU, the 7-year transition period set out in the 2004 Herbal Directive (2004/24/EC) has expired. This means that, as of May 1, 2011, only medicinal products that have been registered or authorized can remain on the shelves. A manufacturer who wishes to register a traditional herbal medicinal product must provide documentation showing that the product is safe for its intended uses. They must also provide evidence that the product has been used safely for at least 30 years, 15 of them in the EU. Although this legislation is different than the NDI requirement in the United States, the intent and approach is quite similar. Smaller herbal manufacturers in the EU are already voicing their concerns about their ability to comply with these requirements. This is, in part due to the scope of the documentation necessary to establish safety. Whether the clarified NDI requirements will present a similar challenge to smaller manufacturers in the United States remains to be seen.

Dietary supplement manufacturers are watchful of events in the EU as they await the NDI guidance. The implications to availability, and potentially cost, of affected dietary ingredients are yet to be determined. If a product is found to contain an NDI that does not have an application filed, that product is considered adulterated and will likely be removed from commerce. It’s possible that the FDA could require retailers and healthcare practitioners to pull thousands of products off the shelves as it determines the safety of these new dietary ingredients. This will also trigger remedial action on the part of the manufacturer. Despite the potential implications, most manufacturers are eager for NDI clarification. Ultimately, this guidance is what the industry has been asking for since 1994. Defining these requirements should help manufacturers submit what the FDA requires. This, in turn, will provide greater assurance of safety to dietary supplement users. Getting there may be somewhat painful, but the destination should be worth it.

Emerson Ecologics

20 June, 2011 (21:28) | Health Care | By: Health news

Message From Emerson Ecologics: The Healthcare Practitioners’ Preferred Distributor of Professional Supplements
Emerson Ecologics is proud to be the leading provider of professional-grade nutritional supplements to the integrative healthcare community. Obtaining that recognition didn’t just happen overnight; it has been earned. For more than 30 years, Emerson has provided confidence and peace of mind to healthcare practitioners and their patients. We strive to maintain that trust and exceed the expectations of our customers every day.
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A broad offering of 20,000 products from more than 250 of the world’s top nutritional supplement manufacturers ensures we are the single source for all a professional’s needs. Placing one convenient order for multiple brands is one simple step to reducing your carbon footprint. Emerson’s real advantage, however, is in the service solutions we offer. By lessening the administrative burden for a practice or clinic, we enable an office to streamline its business practices and focus on what doctors do best—provide high-quality, personalized care to patients.

Since 1980, Emerson has not only worked to seamlessly and efficiently bring professional nutritional supplements to practitioners, we have also been fully committed to sharing the industry’s focus on safety and quality. We take this commitment very seriously and developed the Emerson Quality Programâ„ (EQP) to provide you a better vantage point into making informed decisions about the products you recommend.

As healthcare continues to evolve and patients seek a more proactive and balanced approach to their overall health, we will be here to fully support the healthcare community in providing care. Emerson Ecologics is committed to being the one-stop source for products you can trust, resources you need, and services you deserve.

Quality: The Confidence for Recommending the Best
Emerson Ecologics recognizes that high-quality manufacturing practices are central to the success of the dietary supplement industry. With ongoing concerns continually raised about contaminants, such as heavy metals, it is increasingly important for practitioners to be able to reliably secure information about the quality of supplements. A majority of manufacturers voluntarily apply for third-party quality certification to validate their manufacturing practices for product purity, identity, and potency; however, this information is not readily accessible to healthcare practitioners, and so the EQP was created.

The EQP is a one-of-a-kind, quality assurance program that showcases the quality practices of its participating manufacturers. Voluntary participants provide detailed data on FDA cGMP compliance, raw materials, and finished product testing, which is then scrutinized and verified by Emerson; manufacturers that meet or exceed Emerson’s quality standards are awarded the distinction of EQP Partner, EQP Silver Partner, or EQP Gold Partner. These partners understand quality as an integral part of their business and epitomize a commitment to quality manufacturing that goes above and beyond, representing some of the best quality practices in the industry.
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All this information is compiled into an easy-to-use online tool at emersonecologics.com/quality to provide practitioners and their patients what they need to make informed supplement decisions. Practitioners are able to access information to assist them in evaluating potency, bioavailability, and certainty of material identity and purity. The goal of the EQP is not only to recognize manufacturers that continue to raise our industry’s standards, but most importantly to give practitioners the information to confidently recommend and trust the source of supplements for their patients.

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