Selasa, 26 Januari 2016

3 Important Points About Foreign Medical Products and the FDA Reporting of Safer Medical Devices

One of the major issues regarding the U.S. market and distribution of medical products is the regulation and oversight of medical products coming into the U.S. from abroad. Other countries, especially the less developed nations, have different regulations regarding the production and distribution of medical products, and sometimes these regulations don’t quite meet the standards of U.S. health standards. Most products are produced in the United States, but since some companies will manufacture their products abroad as a cost saving measure, the Food and Drug Administration (FDA) has taken several steps to assure the American public that the medical products that are being manufactured abroad still have the assurance of reliability, effectiveness, and safety that the U.S. manufacturers must provide.

There are a couple foreign countries with strongly improving economies who are greatly increasing their trade with the United States, some of which include Mexico, India, Brazil, China and South Africa, and therefore due to the heavy export of medical devices from these countries, new and stronger regulations from the FDA must be made to asses and inspect these products, especially since these economically emerging countries have less strict medical device manufacturing regulations.

Here are a couple more things that you need to know about medical products and the FDA’s mission to keep foreign-made medical devices and products at the same standard as U.S. made products.

• The FDA has increased their oversight of imported medical devices and products by 13% in the last 10 years, which also means that the amount of products and medical devices produced outside of the U.S. has increased fourfold. One-third of most medical products are produced abroad, and with over 150 countries designated as “developing countries”, the FDA has to make sure that the regulation standards in many of these countries are equivalent to U.S. standards.

• In addition to medical products and devices produced abroad, 80% of the active ingredients in most pharmaceuticals are also produced in countries outside of the U.S. Therefore, most all medicines distributed by pharmaceuticals companies contain ingredients sold from foreign countries. This is especially a problem if the regulations in some of these countries are relaxed and the ingredients are mislabelled or contaminated. One story in particular states that in the 1930s a certain medicine contained a poison that killed around a 100 people. Since then, the FDA has taken considerable effort to try and regulate the importation of medicines and pharmaceutical ingredients.

• In some of the poorest countries that still have a strong medical device manufacturing and pharmaceutical industry have several issues in complying with the global market regulations, including a weakly monitored staff, weak surveillance systems, or even no judicial legislation that would regulate product safety. Some of these countries may import a lot of medical devices and products to the U.S. but within themselves may unable to regulate the safety of these products due to weak infrastructure and a limit of available resources.

The FDA has always been required to monitor and regulate the importation of health products and devices, and even though foreign health product regulation may be deficient in comparison to the U.S. oversight, the FDA still has an obligation to ensure that all medical devices and products pass rigorous testing and annual analysis to ensure the public safety and health of the U.S. citizens who rely their lives upon some of these products.

Sabtu, 20 Desember 2014

Rise in Popularity of Online Pharmacies Has Serious Consequences

Sales regulated controlled drugs through online pharmacies is a growing trend in the United States. In a society heavily influenced by the lure of stifling of prescription drugs currently used to treat a variety of biological and behavioral problems, it comes as no surprise that ultimately many of our medical needs will be met by the online pharmacy retailers. There are many benefits to the type of drug distribution. Population with disabilities or stay at home can have their medication is delivered to their homes, buyers enjoy a certain degree of discretion and anonymity, and a broad product selection. Information items can be easily examined and compared by using the website, and the computer can quickly capture potentially dangerous prescription errors. However, despite the benefits appear online trading, there are many significant weakness is also related to the sale of prescription drugs online.

In a study released last Wednesday July 9, by the National Center for Addiction and Substance Abuse at Columbia University, under the leadership of Joseph Califano, found that most of the websites selling prescription opioids, stimulants, and depression does not require a valid prescription to do so. The increase in the activity of legal drugs have also been associated with the abuse of prescription drugs is growing, especially among students. This year alone there are 365 sites devoted to selling controlled drugs by mail. Generally controlled drugs purchased without a prescription, including Oxycontin, methadone, Vicodin, Xanax, Valium and.

According to a 2005 study completed by Christopher Littlejohn and his colleagues, online merchants can be categorized into four basic types - ". No-prescription" "legitimate", "subscribe," "lifestyle" and legitimate pharmacies operate similar to a traditional pharmacy . Customers must have a prescription from a licensed medical practitioner, and in general this site does not offer any kind of controlled prescription drugs most often obtained illegally and abused. Users pharmacy subscriptions given access to various drugs without a prescription after they sign up for the program and pay a membership fee. This subscription site secretly maintained in hard-to-set areas of the world such as Mexico and Asia. Lifestyle Pharmacies ask customers to fill out a medical questionnaire as a substitute for prescription. They generally provide more elective or fancy drugs that treat conditions such as alopecia, obesity, and impotence. No-Prescription pharmacy just that. These are sites that are willing to submit to the customer controlled drugs online without a prescription. Littlejohn study also found people who are most often ordered illegal drugs of this site is literate, credit cards have individual with internet access. All three of these factors also lead to the conclusion that the perpetrator of the online pharmacy of socioeconomic status are relatively high.

There are many distressing consequences associated with selling prescription drugs online. Unlike conventional pharmacies, there is little or no protection of consumers through the internet. The products can be advertised with false claims and sales of experimental drugs not approved to go unchecked. The administrator illegal sites often remain anonymous and can quickly disable and create a new site that makes it difficult for any regulatory agency to track their activities. Operations are also often run outside the US making law enforcement officials are scrambling to gather international cooperation efforts.

The lack of effective regulation of online pharmacies can lead to disastrous consequences. Francine Haight of La Mesa, California lost her son Ryan overdose of Vicodin generic form, which he ordered without permission online with a debit card. "The Internet makes it easier for drug dealers to sneak into your living room," he said. Online drug sales has led to drug and substance abuse, and death associated with drug interactions, dosage or administration of the wrong, and drugs are not pure. Illegal prescription can end up in the hands of children or others who are not able to use them responsibly.

As sales of controlled drugs without a prescription is a new phenomenon, means to combat the trend is still in development. The FDA has promised to increase the reach and awareness, expand enforcement, and international cooperation to develop a tight bond. In April "Ryan Haight Online Pharmacy Consumer Protection Act" was approved by the Senate and is currently being studied in a House committee meeting. If passed, the legislation would require online pharmacies to be certified true and for doctors to meet with patients before prescribing of controlled drugs. Some state governments have passed laws that regulate the drug trade online but many supporters are pushing more stringent federal regulations. Some search engine companies have begun to fight back against online sellers using a program called, "Pharmacy Checker." Advertisers filter device unlawful and forcing them to provide verification.

Senin, 26 Maret 2012

Knowing Noni Plant used for Cancer Treatment

Have you ever drank herbal kudu laos who peddled mothers carrying herbalist? It feels fresh, slightly spicy-semri

wing, with the distinctive aroma of Noni. It is said that his usefulness is improving blood circulation, warm the body, lowers high blood pressure, increase vitality, improve digestion, eliminate pegel-pains and colds.

Noni-based herbal medicine, laos, Java acids, and sugar (sometimes plus pepper, garlic, kedawung, ginger, kencur, etc.) it is taken down through the generations since the time of the ancestors, suggesting that the drug has had a long history of noni .

As traditional crops throughout the noni plant can be used as a drug. Roots to treat seizures and tetanus, normalize blood pressure, drug fever, and tonic. Bark is used as a malaria drug, tonic, antiseptic to the wound, or restore skin swelling. The leaves are used as a cure dysentery, intestinal cramps, dizziness, vomiting, and fever. While his urine for a laxative, enema, skin softener, seizures, asthma, respiratory disorders, and inflammation of the lining of the joints.

The days of old leaves, roots, and stems noni is more widely used. But lately its use as a drug is more shifted to the fruit. For example, to treat hypertension ripe noni fruit is taken water, mixed with honey, then drink every morning before breakfast. To cope with jaundice two noni take water, mixed with rock sugar, then drink (done twice a week to recover). To cough and itchy throat, ripe noni fruit is eaten with salt. To relieve a fever of the noni fruit with 2 cm ginger boiled in two cups of water until only half of it. Water is taken morning and evening. While the ripe noni fruit rub-rub that can change the skin scaly and cracked heels become smooth again.

There are many other benefits of noni (Morinda citrifolia) is also called the pace (Java), cengkudu (Sunda), kodhuk (Madura), wengkudu (Bali). These plants originated from Southeast Asia, including Indonesia, which later spread to Polynesia (Hawaii). In Polynesia there is a so-called noni noni and utilized more intensively cultivated.


Noni is a fruit and leaf nutrient content of food to complete. In addition to a variety of vitamins, protein, and minerals, Noni also contains xeronine, proxeronine, a natural steroid, alizarin, lysine, sodium, capric acid, caprylic acid, kaproat acid, arginine, antraquinone, trace elements, phenylalanine, selenium, magnesium, etc. other.

Among these nutrients are antibacterial agents that can kill Pseudomonas aeruginosa, Protens morganii, Staphylococcus aureus, Bacillus subtilis, and Escherichia coli (causes diarrhea), Salmonella montivideo, S. scotmuelleri, S. typhii (causes typhoid), and Shigella dysenteriae, S. flexnerii, S. pradysenteriae, and Staphylococcus aureus.

Scopoletin compound there is lots of noni than is antibacterial, anti-inflammatory and allergy, it can also boost the immune system (immunomodulators).


The use of noni for cancer treatment in recent years more and more popular as more research on the benefits of noni for cancer.

University of Hawaii research team led by Annie Hirazumi found that noni juice enhance the immune system works (mainly macrophages and lymphocytes) mice induced with Lewis lung cancer cells, thus able to survive 50 days more. Whereas mice not given noni only able to survive between 9-12 days. Annie is also observed that noni juice is useful for treating sarcoma.

Louisiana State University team, the U.S., led by Conrad A. Hornick, Ph.D. found that noni juice in the levels of 10% can stop the formation of blood vessels (anti-angiogenesis) in breast cancer cells and damage the blood vessels that cancer already exists, so the cancer cells die.

Maria Gabriela was Manuele and his colleagues succeeded in proving that scopoletin can activate lymphocytes to eradicate cancer cells as well as lymphoma.

mengkuduTak to be outdone by his colleagues, Dr. Rangadhar Satapathy, MD stated that the noni plant has 150 Neutraceutical (medicinal nutrients), five of which are anticancer agents:

(1) Polysaccharides are abundant in Morinda prevent the attachment of cells damaged / mutated into other cells, thus preventing the occurrence of metastases.

(2) damnacanthal, similar anthraquinon, inhibits the growth of malignant cells. Alizarin, another anthraquinon, stopping blood flow to tumor tissue, thus stopping its development.

(3) Epigollocatechin gallate (EGCG). Polyphenolic antioxidant flavonoid that is widely available in this noni prevent mutation of cells and induce apoptosis (suicide) in the abnormal cells.

(4) terpenoids in noni preventing malignant cell division and induce apoptosis. One terpenoidnya, limonene, proven effective against breast cancer, liver cancer, lung cancer, and leukemia. Other terpenoids, beta-carotene, helps stimulate the thymus gland to produce more T lymphocytes, cells that can directly destroy cancer cells. Moderate acid type triterpenoid ursolat also can prevent the growth of abnormal cells (cancer) as well as send existing abnormal cells to commit suicide (apoptosis).

(5) According to the research of Dr.. Heinicke, proxeronine very much present in Noni. In the intestine is converted to xeronine proxeronine. Xeronine is also produced in limited quantities this body is required to activate proteins in the cell before it is used throughout the chemical process of the body. Xeronine also improve the structure and function to normalize the body's cells are damaged. Because, basically, every cell contains a protein, then the adequacy of xeronine can fix any kind of abnormal cells. From here obtained an explanation, why xeronine different effects on each person, but generally showed improvement according to each disease.

But behind the impressive benefits of noni so there is one thing that is often an obstacle in taking noni, that smells bad. Aroma is quite pungent, caused by acid and capric acid kaproat there is lots of ripe noni fruit. The means used to reduce this scent is a blend of honey or brown sugar into noni juice, then stored in glass or glass bottles for 2-4 days.

In this fermentation process kaproat acid and capric acid will decompose so that the smell is reduced, unfortunately not yet obtained clear whether this affects the usefulness of fermentation process or not. According to the testimony of its users, noni fruit is not ripe old (not many kaproat acid and capric acid) was less potent than noni fruit is completely ripe.

Noni side effects so far not been found. Only people with kidney problems need to be careful because consuming noni very high potassium levels.

Raspberry as Antioxidant

Fruit beautiful and rich benefits rasberry contain many vitamins are good for your health. It also can be used as an antioxidant. Here's an article I read from

Type of berry fruits has always had a lot of benefits to health, one of which is a raspberry. Although the tiny shape that tends to sour taste, but a lot of benefits for the body. What are ya?

Raspberry, one type of fruit that belongs to the berry-berryan have not lost a lot of benefits with other berries. Raspberry we often encounter a mixture of ingredients to make cake or drinks. Although sometimes used raspberry fruit is not fresh, but tend to already be a jam.

Although the small form, but do not ever underestimate this fruit. Behind its small and the taste is sour, raspberry save a lot of benefits to the body in addition to a fairly high content of nutrisnya. Actually own many types of raspberries, red ranging from raspberries, yellow raspberries, raspberry or orange dijkenal by the term 'albino raspberry', black raspberry and many others.

Types of raspberries are most commonly found and used the red raspberry. Nutrients contained in this raspberry include:

High content of antioxidants can ward off free radicals and aging menlawan early. Repair damaged skin cells that keep the skin moist makes it feel soft and supple. In addition, antioxidants can prevent cell growth and tumor aknker.

Consume more than 3 times a day raspberries can help you better eyesight, especially due to aging. Anthocyanins contained in raspberry fruit reduces the risk of heart disease and prevent the aging process.

It was the acid content indicating a high vitamin C in it. Increase the body's antibodies that are immune to virus attacks the disease. Some studies also suggested that the raspberry is one fruit that is quite safe to eat those who suffer from diabetes. By regularly consuming raspberries, can not easily make the body tired and prevent pain in the joints.

Benefits of Mangosteen Skin's

Mangosteen skin turned out to contain many health benefits. Here are 75 benefits of mangosteen peel that has been clinically tested by researchers and recapitulated from various sources.

"Queen of the tropical fruits"

Mangosteen fruit (Garcinia mangostana. L) growing wild in the forests and mountains with trees can reach heights over 15 feet but has the fruit that takes more than 10 years. Indonesia as a country that has abundant biodiversity is one of the mangosteen production centers which are exported to various parts of the world such as America and Europe. Based on the information I can, in Europe there selling mangosteen peel is very high. There are skin mangosteen juice be worth about 20 U.S. dollars or about 200 thousand dollars per glass. Whereas in our country, mangosteen be used as a guessing game even could be "gambling".

There may have long believed that the mangosteen fruit is nutritious, but about the benefits of mangosteen peel only recently "rising star". Skin color is purple mangosteen is believed to be rich in powerful antioxidants.

Mangosteen peel of the queen of all tropical fruits (Queen of The Tropic Fruits) can produce xanthone compounds, ie substances that are formed from the isolated skin of the mangosteen fruit. Levels reached 123.97 mg per ml. Xanthones have anti-inflammatory and antioxidant activity. Xanthone compounds to counteract free radicals and prevent cell damage that hampered the process of cell degeneration. Especially today, we have many contaminated by chemicals, pollutants and artificial ingredients, and it's all inevitable. In addition Xanthones not only as antioxidants, but also anticancer. Lately, scientists also are conducting trials mangosteen peel as potential HIV drug.
Here are 75 facts for the health benefits of mangosteen peel:

comprehensive health

A. Strengthen the immune system.
2. Heal the inflammation.
3. Improving communication between cells.
4. DNA damage fail.
5. Tool of the lymph system.
6. Maintains optimal thyroid function.
7. Reduce insulin resistance.
8. Help with weight loss.
9. Heal nerve damage.
10. Balances the endocrine system.
11. The tools of the synergy of the body.
12. Relieve hemorrhoids.
13. Help lower blood sugar levels (hypoglycemia).
14. Kemerah-merahan/bersisik alleviate skin disease (psoriasis).
15. Help heal wounds.
16. Relieve pain from carpal tunnel syndrome (a disease that occurs in the wrist and fingers caused by pressure that often occurs in the section. And usually are caused by too frequent use of keyboard and mouse).
17. Removes dry scaly skin disease chronic (neurodermatitis). The anti-inflammatory properties of mangosteen can reduce the scales and itchy skin disease.
gastrointestinal smooth

18. Help treat GERD (chronic disease characterized by the flow of stomach acid into the esophagus).
19. Helps heal ulcers / sores.
20. Relieve irritable bowel syndrome (IBS).
21. Help stop diarrhea.
22. Can ease the inflammation of the small or large intestine known as Crohn `s disease.
23. One can prevent inflammatory bowel disease (diverticulitis).
Heart Health

24. Help prevent heart disease.
25. Strengthen blood vessels.
26. Lowering LDL cholesterol.
27. Lowering high blood pressure.
28. Helps prevent arteriosclerosis.
Make More Younger

29. Increase energy, enhance the excitement and increase stamina.
30. Slow the aging process.
31. Help prevent deterioration of the brain disease (dementia and Alzheimer `s).
32. Help prevent kidney stones.
33. Help prevent nervous system diseases (Parkinson's).
34. Relieve pain from arthritis.
35. Repairing the damage from the use of painkillers (NSAIDs).
36. Aids to the eye.
Family Health

37. Reduce fever.
38. Overcome food poisoning.
39. Heal the wounds of the throat.
40. Help heal canker sores.
41. Fights bad breath.
42. Help reduce the migrants (the headaches).
43. Reduce the toothache.
44. Natural sleep aids.
45. Improved ability to cope with stess.
46. Improve mood and reduce depression.
47. Aids muscles and joints.
48. Get rid of acne and the defects of the skin.
49. Eliminating the bite marks, burns and poisoning.
50. Relieve sprains, muscle and joint tension.
51. Relieve abdominal pain.
52. Relieve laryngitis (bronchitis), emphysema (emphysema), and inflammation of the lungs (pneumonia).
53. Working as painkillers tightness / congestion in the nose (decongestant).
Men's Health

54. Help prevent infertility.
55. Help prevent prostate enlargement.
Women's Health

56. Relieve urinary difficulties.
57. As a gentle laxative.
58. Minimize symptoms of pain before menstruation (PMS).
59. Relieve the symptoms of menopause.
60. Decrease swelling during menstruation.
61. Meringkan pain in muscles, ligaments, or tendons (fibromyalgia).
62. Relieve pain from the disease decreased bone density / calcification of the bones (osteoporosis).
Children's Health

63. Help meringkan asthma.
64. Could prevent the disorder and attention deficit hyperactive disorder (ADHD) and food allergies.
65. Form teeth and bones stronger.
Overcoming Disease

66. Prevent gum disease.
67. Eradicate tuberculosis.
68. Decrease the side effects of lactose intolerance.
69. Helps prevent dysentery.
70. Help prevent central nervous system diseases (multiple sclerosis).
71. Can prevent cancer.
72. Alleviate the chronic inflammatory disease (chronic inflammation) that attacks the spinal structures and especially of the hip joint (Ankylosing Spondylitis).
73. Help prevent lung infections and chronic respiratory (cyctic fibrosis).
74. Prevent symptoms associated with lupus disease.
75. Reduce severe muscle weakness disease (Myasthenia Gravis)