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Roche lists the following approaches for improving affordability: securing reimbursement through commercial arrangements and/or differential pricing buy yasmin 3.03 mg free shipping birth control for women quotes; assisting patients who pay out-of-pocket through patient assistance programmes yasmin 3.03 mg with amex birth control pills japan; contributing to the development of private health insurance coverage discount 3.03mg yasmin otc birth control pills gain weight. Roche is in the process of establishing differential pricing programmes for their therapies yasmin 3.03 mg line birth control video, including anti-cancer drugs, in low- and middle-income countries. In the Philippines, Roche is experimenting with a tiered pricing scheme for Herceptin that is linked to the individual patient’s ability to pay, as assessed by a third party. There is no information publicly available about the price levels that have been set, nor the outcome of the programme. However, based on information from a blogger/journalist in the Philippines writing about 31 Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication. Roche points out that there are many challenges with implementing differential pricing, identifying the use of international reference pricing as a concern. Roche calls for global solidarity to ensure that lower prices granted to low- and middle-income countries are not taken advantage of by high-income countries. They want to see inter- governmental action to ensure that reference pricing and parallel trade are not used outside groups of countries of the same economic development level. Another approach to differential pricing is through ‘second brands’ which means that the same product has a different brand name and packaging from the original Roche product. Examples of a cancer drug second brand includes Herclon, a renamed and repackaged brand of trastuzumab (Herceptin) provided by Emcure in India, following an agreement with Roche. In 2003 the New York Times criticized Novartis for using the programme to prevent generic supply by threatening to stop its donations when generic versions of the medicines are made available, and to enlist patients to lobby 106 for reimbursement of the drug. In the case of cancer medicines they use direct-to-patient donations, which involve case-by-case management. Drug donations can never provide a sustainable answer to the current cancer care crisis in low- and middle-income countries. Differential pricing is only practised in the case of the antimalarial drug Coartem – which is a second brand of the antimalarial drug artemeter/lumefantrine sold under the brand Riamet for travellers from high- income countries. Novartis is open to 107 licensing of their patents for neglected tropical diseases research only. Sanofi’s central approach to affordability is through ‘a differentiated pricing policy to help ensure medicines are affordable for all’. And to ‘Adapt our commercial offering based on the economic conditions in the countries we seek to help’. Cancer is mentioned in the context of support programmes for prevention, diagnosis and follow-up, for chronic diseases (e. But the website does not list a programme or outlines an approach to provide access to Sanofi’s cancer medicines. Genzyme, a Sanofi biotech company, works with Project Hope and the National Cancer Coalition to donate medicines. It provides the following information about access to its products in developing countries: Outside the United States, medical care is often managed and funded by national governments. In such countries, Genzyme works closely with governments to help facilitate approval of our treatments and ensure that they are accessible to citizens covered by national health services (Genzyme. In developing countries, we help physicians and local authorities build sustainable health care systems that can pay for critical treatment. Where such systems do not yet exist, we provide free treatment to patients in the interim until longer-term, sustainable solutions can be established locally. Bristol-Myers Squibb Bristol-Myers Squibb, according to its own website, is a global BioPharma company that is producing medicine to help patients in their fight against major diseases, including cancer. On access to medicine in the developing world, the company claims to work closely with government health authorities and other payers in seeking marketing authorization and reimbursement for therapies, while also relying on a number of companywide policies, programmes, and innovative initiatives to guide their efforts. Bristol-Myers Squibb stresses ‘with particular importance, the pressing need for medications produced by this company in low-and middle-income countries in the developing world. Since 1999 the foundation has allocated $150m in grants for medical research and care and community support. The three areas ‘pricing and assistance’, ‘access management’, and ‘patent, licensing and technology transfer’ are most relevant to this report. The area ‘pricing and assistance’ lists the following with regards to access to cancer medication. Through the ‘Bridging Cancer Care’ programme of the Bristol-Myers Squibb Foundation, seven initiatives to improve cancer care in Russia are supported by Foundation grants. The grants, totalling $1m, focus on improving the capabilities of nurses in cancer care. The website does not provide information about the number of patients that have been able to benefit from access to cancer treatment under the listed activities. Bayer Bayer has patient assistance programmes for kidney cancer and liver cancer patients in countries of South and Southeast Asia, in Brazil, and several countries in South Eastern Europe. In 2008, Bayer implemented a Patient Assistance Programme in India along with the market launch of sorafenib (Nexavar) in the Indian market. According to the Bayer website, the programme reduces the cost of the monthly treatment of the patented Bayer drug therapy for qualified patients enrolled, to about 10 percent of the regular 110 pharmacy price for the complete duration of treatment. Conclusion Drug companies’ policies for access to cancer drugs do not seem to be well developed. Companies’ access approaches for cancer lean heavily on traditional drug donations/charitable approaches and are often on a case-by-case basis. For example, none of the websites mention licensing approaches for cancer 35 Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication. Roche’s experimentation with second brand production of trastuzumab by Emcure in India comes closest to a licensing approach. Differential pricing can be interesting if the different pricing levels indeed reflect the ability of the target population to pay. In reality this is hardly ever the case as is illustrated by the case of Herceptin in the Philippines. As long as cancer drug prices are seen as unsustainable in high-income countries, it may be difficult to gain support for a global agreement that limits the use of reference pricing. Nevertheless, Roche’s proposal to reach a global agreement on reference pricing based on groupings of countries with similar levels of economic development should be further explored if this could indeed lead to affordable 112 medicines and not ring-fencing of markets to maximize profits in each. The companies’ websites give the impression that none of them has a coherent approach to access to cancer medication for people in low- and middle-income countries. For this to change the business model of the industry will need to change drastically. The information in this chapter is based on publicly stated policies provided by the companies on their websites. More in-depth exploration may be needed to gain a full picture of companies’ approaches to increasing access to cancer medications. For example, compulsory licensing, including government 36 Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication. India and Thailand are the only countries that have used compulsory licensing for cancer medication. India Compulsory licensing of cancer drugs India is home to generic drug producers that are capable of making low-cost cancer drugs. When a product is patent protected a generic company can only make a copy if it has a license to do so. Non-voluntary or compulsory licenses allow generic versions of cancer medications to be produced despite the existence of a patent. In general, generic versions of medicines are less costly than the originator’s product. Box 8 – Compulsory licensing of biologics The development and production of biosimilar biotechnology products by generic companies require considerable investments. Generic companies are not likely to make such an investment if they are not assured that patent barriers are cleared away.
Numerous attempts have been made to improve malaria microscopy cheap 3.03 mg yasmin overnight delivery birth control pills that increase breast size, but none has proven to be superior to the classical method of Giemsa staining and oil-immersion microscopy for performance in typical health care settings (9) buy discount yasmin 3.03mg on-line birth control bleeding. Cassettes and cards are easier to use in diffcult conditions outside health facilities quality yasmin 3.03 mg birth control pills cycle. The tests have many potential advantages generic yasmin 3.03mg mastercard birth control for women 70s, including: • rapid provision of results and extension of diagnostic services to the lowest-level health facilities and communities; 138 • fewer requirements for training and skilled personnel (for instance, a general health worker can be trained in 1 day); and • reinforcement of patient confdence in the diagnosis and in the health service in general. Severe malaria on Not a Yes Microscopy admission alone can also show Follow-up of parasite density. Health workers Microscopy in the community requires and at health Yes No a reliable posts electricity supply. Although providers of care may be willing to perform diagnostic tests, they do not, however, always respond appropriately to the results. It is therefore important to ensure the accuracy of parasite- based diagnosis and also to demonstrate this to users and to provide them with the resources to manage both positive and negative results adequately (16). Immunodiagnosis and nucleic acid amplifcation test methods Detection of antibodies to parasites, which may be useful for epidemiological studies, is neither sensitive nor specifc enough to be of use in the management of patients suspected of having malaria (17). They are also useful for studies of drug resistance and other specialized epidemiological investigations (18); however, they are not generally available for large-scale feld use in malaria- endemic areas, nor are they appropriate for routine diagnosis in endemic areas where a large proportion of the population may have low-density parasitaemia. At present, nucleic acid-based amplifcation techniques have no role in the clinical management of malaria or in routine surveillance systems (19). Malaria and human immunodefciency virus infection among male employees of a sugar estate in Malawi. A prospective evaluation of a clinical algorithm for the diagnosis of malaria in Gambian children. Clinical predictors of malaria in Gambian children with fever or a history of fever. Major reduction in anti-malarial drug consumption in Senegal after nation-wide introduction of malaria rapid diagnostic tests. Challenges in monitoring the impact of interventions against malaria using diagnostics. The method ensures a transparent link between the evidence and the recommendations (see section 1. It may also be used as follow-on treatment in severe malaria when the patient is well enough to take oral medication. This combination is currently recommended in the Sahel region of sub-Saharan Africa in areas where malaria transmission is intense and where the majority (>60%) of clinical malaria cases occur during a short period (≤ 4 months) (2). Artesunate–amodiaquine should not be used for prophylaxis, as its accumulation increases the risks for hepatotoxicity and agranulocytosis (1). Pharmacokinetic parameters reported for amodiaquine and its active metabolite desethylamodiaquine in studies of currently recommended dosages for treatment of uncomplicated malaria or seasonal malaria chemoprevention (range of mean or median values reported). While amodiaquine is eliminated rapidly, desethylamodiaquine is eliminated more slowly, with a terminal half-life of 4–10 days (4–13). Other commonly reported adverse events include cough, anorexia, insomnia, fatigue and weakness (4, 6, 16–18). Serious adverse events associated with amodiaquine are neutropenia and hepatotoxicity (19–22). While these effects were most often associated with prolonged use of amodiaquine (as prophylaxis), they have also been observed with short-course artesunate– amodiaquine treatment. Less common events that have been reported include arrhythmia, bradycardia, vomiting, extrapyramidal effects and pruritus (14, 15, 23, 24). Eye disorders, varying in type and severity have been reported, including transient accommodation disorders and corneal opacifcation, which regressed once treatment was stopped, and, very rarely, irreversible retinopathy (3). It is important that parents or guardians continue to use other malaria prevention measures (such as insecticide-treated bednets) and monitor their children; they should seek medical attention immediately in the event of febrile illness. Cardiovascular effects have been reported during high-dose treatment with other 4-aminoquinoline derivatives. There is no evidence, however, that an overdose of amodiaquine causes any of the life-threatening cardiovascular complications seen with overdose of chloroquine. Caution should nevertheless be exercised in treating patients who have recently taken another antimalarial drug with cardiovascular side-effects, such as quinine or mefoquine. Pragmatic dosing Fixed dose artesunate + amodiaquine result in better treatment effcacy than loose tablets (29). Antimalarial dosing has often been based on age because access to formal health services or functioning weighing scales is often limited in malaria- endemic countries. While age-based dosing is more practical, it carries a risk for potential under- or over-dosing of more patients. Large datasets of weight-for-age have been used to determine suitable age-based dosing for African children (30), which resulted in higher proportions of patients receiving therapeutic doses of A artesunate and amodiaquine. To simplify dosage recommendations in other regions, 5 anthropometric data should be collated for each malaria-endemic region and the data re-modelled accordingly. Effect of concomitant artesunate administration and cytochrome P4502C8 polymorphisms on the pharmacokinetics of amodiaquine in Ghanaian children with uncomplicated malaria. Pharmacokinetics of artemether–lumefantrine and artesunate–amodiaquine in children in Kampala, Uganda. Tolerability and pharmacokinetics of non-fxed and fxed combinations of artesunate and amodiaquine in Malaysian healthy normal volunteers. Pharmacokinetics of amodiaquine and desethylamodiaquine in pregnant and postpartum women with Plasmodium vivax malaria. Population pharmacokinetics of amodiaquine and desethylamodiaquine in pediatric patients with uncomplicated falciparum malaria. Population pharmacokinetics and pharmacodynamic considerations of amodiaquine and desethylamodiaquine in Kenyan adults with uncomplicated malaria receiving artesunate–amodiaquine combination therapy. The disposition of oral amodiaquine in Papua New Guinean children with falciparum malaria. Population pharmacokinetic and pharmacodynamic modeling of amodiaquine and desethylamodiaquine in women with Plasmodium vivax malaria during and after pregnancy. Anti-malarial drug safety information obtained through routine monitoring in a rural district of south-western Senegal. Safety of artemisinin-based combination therapies in Nigeria: a cohort event monitoring study. A randomized comparison of dihydroartemisinin–piperaquine and artesunate–amodiaquine combined with primaquine for radical treatment of vivax malaria in Sumatera, Indonesia. Frequency of severe neutropenia associated with amodiaquine prophylaxis against malaria. Deux hepatites fulminantes survenues au cours d’un traitement curatif par l’association artesunate–amodiaquine. Electrocardiographic study in Ghanaian children with uncomplicated malaria, treated with artesunate–amodiaquine or artemether–lumefantrine. Artesunate- and amodiaquine-associated extrapyramidal 5 reactions: a series of 49 cases in VigiBase. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide-treated bednet in Mali: a randomised, double-blind, placebo-controlled trial. Intermittent preventive treatment of malaria provides substantial protection against malaria in children already protected by an insecticide- treated bednet in Burkina Faso: a randomised, double-blind, placebo- controlled trial. A trial of the effcacy, safety and impact on drug resistance of four drug regimens for seasonal intermittent preventive treatment for malaria in Senegalese children. The effect of dosing strategies in the therapeutic effcacy of artesunate-amodiaquine for uncomplicated malaria; a meta- analysis of individual patient data. Use of weight-for-age-data to optimize tablet strength and dosing regimens for a new fxed-dose artesunate–amodiaquine combination for treating falciparum malaria. Structure and mechanism of action F H3C H3C Artemether is the methyl ether derivative ofH3C F F F dihydroartemisinin. It is two- to threefold less F N O O active than dihydroartemisinin, its active O O C O C O C F O O metabolite.
Biomedical treatments will not help every child generic yasmin 3.03mg visa birth control care center, but they have helped thousands of children improve discount yasmin 3.03 mg overnight delivery birth control pills no period yet, sometimes dramatically discount 3.03mg yasmin amex birth control for 3 years pregnancy. This summary is primarily based on the excellent book “Autism: Effective Biomedical Treatments” by Jon Pangborn discount yasmin 3.03 mg without prescription birth control for women yellow, Ph. That book provides much more depth on the testing and treatments which are briefly summarized in this document. After reading this document, it is highly recommended that you go to those sources for more information. Similarly, speech therapy, sensory integration, physical therapy, occupational therapy, and a good educational program can be very important. Finally, social interventions (such as Relationship Development Intervention) and social groups can be very helpful in building social relationships and skills. Biomedical therapy may help improve the efficacy of these other interventions, by improving brain and body health and making it easier for the child to learn. His research has included studies of vitamins, minerals, essential fatty acids, amino acids, neurotransmitters, heavy metal toxicity, detoxification, gastrointestinal bacteria, immune system regulation, and sleep disorders in children and adults with autism. Consensus Report on Treating Mercury Toxicity in Children with Autism, and serves on the Executive Committee of Defeat Autism Now!. He is also the President of the Autism Society of America – Greater Phoenix Chapter, and father of a teen-age girl with autism. The key point to remember is to observe the effect of each treatment on your child, both behaviorally and through testing where possible. Autism is a spectrum disorder, and a treatment that helps one child may not help others. Adams, and does not necessarily represent the views of Arizona State University, Autism Society of America, Defeat Autism Now! A balanced diet rich in vegetables, fruits, and protein is important to help provide those key nutrients. Explanation of Diet: • Consume 3-4 servings of nutritious vegetables and 1-2 servings of fruit each day. Benefits: • Vegetables and fruits contain essential vitamins, minerals, and phytonutrients to improve and maintain mental and physical health. The immune system recognizes those foods as foreign, and may launch an immune response to those foods, resulting in an allergic response. Testing: Some allergic reactions are immediate, and some are delayed by hours or days; the latter are much harder to detect. Some responses are very strong, such as rashes or even anaphylactic shock, whereas other reactions are milder such as headaches or stomachaches. Observations: Look for red cheeks, red ears, and dark circles under eyes which may indicate allergies. Diet Log: Keep a diet log, and look for a pattern between symptoms and foods eaten in the last 1-3 days. IgE related to an immediate immune response, and IgG relates to a delayed immune response. Skin testing: less useful than blood testing, as it only checks for immediate response. All allergy testing is limited, in that IgE tests can be negative even if there are clinical symptoms of food allergy. If you cannot afford or do not wish to do the testing, another option is to try an elimination diet of the most common reactive foods which include gluten, dairy, cane sugar, corn, soy, yeast, peanuts, egg, artificial colors and preservatives. If there is improvement, then try challenging the children with one pure food every 4 days, to see if any can be added back in. Benefits: Removing allergic foods can result in a wide range of improvements in some children, especially improvements in behavior and attention. Immune response to dietary proteins, gliadin and cerebellar peptides in children with autism. A study by Lucarelli et al found that an 8-week diet which avoided allergic foods resulted in benefits in an open study of 36 children. A study by Kushak and Buie found that children with autism may have low levels and/or underactive digestive enzymes for complex sugars, which reduces the ability to fully digest starches and sugars. Several studies by Horvath, Wakefield, Buie, and others have demonstrated that gut inflammation is common in autism. This may result in a “leaky gut” that may allow partly-digested food to pass into the blood, potentially causing an allergic response.. Horvath K et al, Gastrointestinal abnormalities in children with autistic disorder,” J. Humans are the only animal who drink milk as adults, and the only animal to drink the milk of another animal. Cows milk is a perfect food for baby cows, but not for humans, especially past age of nursing. Gluten (in wheat, rye, barley, and possibly oats) and casein (in all dairy products) can cause two problems: 1. They are common food allergens (see previous section), especially in children and adults with autism. Certain peptides from gluten and casein can bind to opioid-receptors in the brain, and can have a potent effect on behavior (like heroin or morphine), causing problems including sleepiness, inattention/”zoning out”, and aggressive and self-abusive behavior. Like opioids, they can be highly addictive, and a lack of them can cause severe behaviors. These problems appear to be due to: 1) A failure of the digestive tract to fully digest the gluten and casein peptides into single amino acids 2) Inflammation of the gut, allowing the gluten and casein peptides to enter the bloodstream and reach opioid receptors in the brain. Explanation of Treatment: • Total, 100% avoidance of all gluten products and all dairy products. Even small amounts, like a bite of a cookie, can cause allergic and/or opioid problems. Many foods have trace contamination with gluten, such as dusting French fries and raisins with wheat powder to keep them from sticking, so it can be very difficult to avoid all foods and contaminated foods. Benefits: Children who most crave dairy and/or wheat, and who eat a lot of it, are most likely to benefit. Casein-free diets usually produce benefits within a month, and sometimes within a week. In some children there is a worsening of symptoms for a few days (similar to a drug withdrawal) followed by improvement. Safety Note: It is important that a calcium supplement be taken while on a dairy-free diet unless a child has an exceptionally nutritious diet rich in calcium. However, a negative allergy test does not mean that dairy and wheat are ok, as they can also cause problems due to opioid action. Cade’s large study of 150 children with autism found that 87% had IgG antibodies (allergy) to gluten, vs. Large improvements were observed in social isolation, eye contact, mutism, learning skills, hyperactivity, stereotypic activity, and panic attacks. Elder et al, The gluten-free, casein-free diet in autism: results of a preliminary double blind clinical trial. For example, many women lack enough calcium and iron, leading to osteoporosis and anemia, respectively. Explanation of Treatment: Vitamins and minerals are available in vegetables, fruits, meat, and other sources. Juicing: One option is to use a juicer to make fresh vegetable/fruit juice, and storing it for up to a few days in an airtight glass container. Fresh vegetable/fruit juice is a rich source of vitamins, minerals, and other nutrients. Commercial juices are “pasteurized” or heated to destroy bacteria, which also causes a loss of some nutrients.
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