Tucson, U.S.A. — The United States is forfeiting a half century of leadership in medical care and medical research and development, writes orthopaedic surgeon Lee Hieb, M.D., in an article in the winter issue of the Journal of American Physicians and Surgeons.

“We are rapidly throwing it all away as we spiral ever downward into a “vampire economy”—an economy so overtaxed and overregulated that it is sucking the lifeblood out of its productive citizens, she writes.

Hieb undertakes a diagnostic examination of the medical economy, and features the following findings:

• There are 140,000 pages of regulations pertaining to Medicare, compared with a “mere” 82,000 in an impossibly complex tax code.
• Today, 49 cents out of every dollar is spent by government. In 1920, only 10 cents was spent by government, and 90 cents privately. Even in 1947, after World War II and the Marshall Plan, only 20 cents of every dollar was spent by government.
• Businesses are organized into cartels. Some are favored by government, so that profits are retained privately, but losses are shared by taxpayers.

The diagnosis, Hieb writes, according to the Austrian school of economics, is that we have a classic fascist economy. According to Lwewellyn Rockwell, “Fascism is the system of government that cartelizes the private sector, centrally plans the economy to subsidize producers, exalts the police state as the source of order, denies fundamental rights and liberties to individuals, and makes the executive state the unlimited master of society.”

Hieb’s description of the economy comes from the title of Guenther Reimann’s 1938 book, The Vampire Economy: Doing Business Under Fascism.

“The frontispiece of Reimann’s book is a pictorial representation of what it took a car manufacturer to get 5,000 tires for his autos. After 6 months and numerous encounters with boards, chambers, secretaries, ministers, councils, and commissars, the company received 1,000 rubber tires and 4,000 ersatz tires, at a 200% increase in price.”

Hieb compares this with the U.S. Food and Drug Administration (FDA), although the FDA takes 15 years to approve a drug, not just 6 months.

When F.A. Hayek wrote The Road to Serfdom in 1928, 55 percent of the German economy was controlled by the government, and their military expenditure was 10 percent of their budget. Today in America it is estimated that 45 percent of our economy is controlled by the government, and our military consumes 21 percent of the national budget.

Hieb explores the moral hazards of dependency on government money, and warns physicians: “We must never put ourselves in such financial dependency on the government that we are willing to compromise Hippocratic principles of ethical patient care.” Independence, she writes, is the “garlic necklace.”

The Association of American Physicians and Surgeons (AAPS), a national organization representing physicians in all specialties, founded in 1943, publishes the Journal of American Physicians and Surgeons.

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New York, U.S.A. — In a recent interview for Fox News, Martin Smithmyer, CEO of Americord Registry, one of the industry’s leading cord blood banking companies, said, “Although [Americord] does not pay doctors for making referrals, this is a common practice among some of our competitors, including at least 3 of the top 6 cord blood banks.”

The Obama administration, in January 2012, made it clear that under the new health care law it will require certain healthcare companies to disclose payments they make to doctors – sometimes amounting to hundreds of thousands or even millions of dollars – for research, consulting, speaking, travel and entertainment. The American Congress of Obstetricians and Gynecologists (ACOG), recommends doctors disclose such payments and arrangements to patients.

Furthermore, according to Smithmyer, cord blood has certain limitations that parents should know about before they decide to bank their child’s cord blood, since the cost of cord blood banking is not an insignificant consideration when making this decision.

“Although in this field the technology is always changing, the number of stem cells in one unit of cord blood today is only sufficient to treat a child up to about 10 years old,” said Smithmyer. Americord Registry is developing a new technology that will collect up to 10 times more stem cells. This would be enough to use therapeutically for an adult. To learn more, read the full article from Fox contributor: 7 things you should know about cord blood banking.

About Americord Registry

Americord Registry is a company involved in umbilical cord blood, cord tissue and placenta stem cell preservation. Americord collects, processes, and stores newborn stem cells for future medical and therapeutic use, including the treatment of more than 80 diseases such as leukemia.

Founded in 2008, Americord is registered with the Food and Drug Administration. The company’s laboratory is accredited by the AABB and complies with all federal and state regulations, including federal CLIA laboratory standards. Americord is based in New York, NY.

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New York, U.S.A. — The July 9 New York Times article, “More Women Look Over the Counter for a Libido Fix,” by Abby Ellin is a story about how a low sexual libido is surprisingly common in young women and how the marketplace is starting to respond to women’s plight for sexual enhancement products.

“With the recent advent of media bringing female sexuality to the forefront such as the book 50 Shades of Grey and the film ‘Magic Mike,’ a women’s sex drive, which until recently was not a family-friendly topic is now water cooler conversation. Women are no longer ashamed to talk about their sex lives or their desire to improve them,” said Dr. Michael L. Krychman, Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine.

Rachel Braun Scherl, president of Semprae Laboratories, the manufacturer of Zestra explains, “There are a number of factors that will lower a women’s libido, desire, arousal or satisfaction, many of which are not age-specific. These include side effects from medications including oral birth control and anti-depressants; hormonal changes due to post pregnancy or menopause; the physiological and emotional impact of cancer treatment; realities and side effects of medications for a number of medical conditions including diabetes, obesity and MS; and the all-encompassing stress.”

In the absence of an FDA approved female counterpart to men’s sexual satisfaction drugs like Viagra, Cialis and Levitra, many women are turning to over-the-counter products, including lubricants, arousal gels, massage oils, nutritional and herbal supplements, and vibrators.

Chain stores, including drugstores, are now selling these products. Zestra Essential Arousal Oils, for example, is now sold in 1,800 Wal-Mart’s, up from 880 in 2010, as well as Kmart, Rite Aid and Meijer. Rachel Braun Scherl explains, “Clearly, women and men are asking for these products. Zestra has kept its retail shelf space with just one retail product (although broader range is available online).”

Zestra’s second double-blind clinical study, the only study of its kind to be printed in a medical journal, was conducted with women 21 to 65 demonstrating that Zestra, a blend of botanical oils and extracts, worked equally effectively for women of all ages and reproductive life stages.

Female sexual dysfunction becomes an official diagnosis (to be called female sexual interest/arousal disorder) in the DSM-V, the new edition of the psychiatric diagnostic manual, due in 2013.

Still, the proliferation of these sexual enhancement products — and their emphasis on fixing a problem that is extremely hard to define — leaves some people worrying that women will start focusing on so-called trouble spots and putting pressure on themselves to perform. Rachel Braun Scherl advises, “Our idea is not to get women to have more sex — not that there is anything wrong with that — it’s that if they’re having sex they should enjoy it.”

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Halifax, U.S.A. — Under a US Army contract valued at USD$4.2 million, MedMira will develop and commercialize this multiple rapid test which detects HIV, Hepatitis B and C simultaneously in 3 minutes from a single drop of blood.

MedMira Inc., a developer of rapid diagnostic technology and solutions, announced today that it has been awarded a U.S. Army Medical Research Acquisition Activity (USAMRAA) contract to develop and commercialize a rapid test capable of simultaneous detection of HIV and Hepatitis B and C.

The contract, awarded through a competitive bid process, involves a two-year base period and a 10-month option with a value of USD$4,266,144, if all options are exercised. MedMira presented its technology and multiple rapid tests, which met the U.S. Army’s advanced technology readiness level requirements. The Multiplo Rapid HBV/HIV/HCV Antibody Test resulting from this contract award will be deployed on the frontlines of military healthcare for use in emergency screening for transfusion transmitted diseases where no FDA approved donor screening tests are available. The military could also put the test to use during pre and post deployment screenings and civilian disaster relief efforts.

“We are thrilled to receive this new contract from USAMRAA for the development and commercialization of our Multiplo test. This contract award demonstrates the excellent fit between MedMira’s technology and products and military requirements. We have built a lasting relationship with the U.S. Army, delivering advanced diagnostic solutions that reduce the need for militaries to undertake ground-up development work,” said Hermes Chan, CEO, MedMira Inc. “MedMira’s technology and products are elegantly simple, portable, fast, and high quality. All of these attributes are mission critical in deploying diagnostic healthcare solutions on the frontlines of military healthcare.”

Chan continued, “Our team recently attended a conference focused on military pre-hospital trauma management where we heard first hand of the need for a multiple rapid HBV/HIV/HCV test from many of the leading experts, military personnel, and medical professionals in this field.”

Under contract number W81XWH-12-C-0151 the U.S. Army will fund all development costs and associated fees in obtaining a U.S. Food and Drug Administration (FDA) premarket approval (PMA) for this multiple rapid test. The scope of work under this contract will see MedMira advance and fully commercialize a multiple rapid test that will simultaneously detect three of the most serious infectious diseases, namely HIV-1/2, Hepatitis B, and C antibodies within three minutes using just a small drop of blood. Once approved, the product will be supplied by MedMira directly to the U.S. Army and to other customers throughout the world, both military and civilian, via the Company’s distribution network.

“A multiplexed test for transfusion transmitted diseases provides an enabling technology that will be used to mitigate risk in austere environments where emergency blood collections are necessary to save lives of severely wounded war fighters,” said Colonel Richard Gonzales, Product Manager, U.S. Army Medical Materiel Development Activity.

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Pasadena, U.S.A. – People who have had an episode of herpes zoster, also known as shingles, face a relatively low short-term risk of developing shingles again, according to a Kaiser Permanente Southern California study published online in the Journal of Infectious Diseases. These findings suggest that among people with immune systems that have not been compromised, the risk of a second shingles episode is low.

Researchers reviewed electronic health records and monitored recurrence of shingles for more than 6,000 individuals. They found fewer than 30 cases of recurrent shingles in an average of two years of follow-up and little difference in the rate of recurrence between the vaccinated and unvaccinated population.

“This study’s findings are important because we found that the risk of having a recurrent shingles episode is not as high as previous research indicates,” said Hung Fu Tseng, PhD, MPH, study lead author with the Kaiser Permanente Southern California Department of Research & Evaluation in Pasadena, California. “We now have empirical data that show the risk of recurrence is low among an elderly population who did not have compromised immune systems, regardless of their vaccination status.”

More than 1 million people develop shingles every year in the United States. Shingles is a painful contagious rash caused by the dormant chickenpox virus, which can reactivate and replicate, damaging the nerve system. The elderly are especially vulnerable because immunity against the virus that causes shingles declines with age.

When the Food and Drug Administration approved the shingles vaccine in 2006, the agency said that having an episode of shingles boosts immunity and suggested it was unlikely that people would experience a recurrence. It further stated that the effectiveness of the vaccine in preventing repeat episodes had not been proven in clinical trials because trials have not been conducted.

By contrast, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended the herpes zoster vaccine for people ages 60 and older, including those who reported a previous episode.

“While this latest study adds to the growing evidence base of emerging knowledge about the shingles vaccine, more research is needed. Our findings need to be replicated by studies with larger populations. Kaiser Permanente Southern California researchers will continue to follow this population of vaccinated people in order to determine the long term preventative efficacy,” said Dr. Tseng.

Researchers studied electronic health records for 1,036 vaccinated and 5,180 unvaccinated Kaiser Permanente members aged 60 and older. The vaccinated population included members who received vaccines between 2007 and 2010. The zoster vaccine is not recommended for patients with immune systems that have been compromised as a result of cancer or other medical conditions, so they were excluded from this study.

Based on the clinically confirmed cases, researchers found the risk of the recurrence of shingles after a recent episode is fairly low, regardless of vaccination status. Each year, on average, 19 persons per 10,000 in the vaccinated cohort experienced a recurrence of shingles. The rate was only slightly higher for the unvaccinated population, at approximately 24 persons per 10,000 per year.

This is the latest in a series of published Kaiser Permanente studies conducted to better understand vaccine effectiveness and safety. In 2011, Dr. Tseng was a lead researcher in a Vaccine Safety Datalink study published in the Journal of Internal Medicine that found the herpes zoster vaccine to be safe. Also last year, Dr. Tseng published a study in the journalVaccine that found that administering the pneumococcal and the herpes zoster vaccines at the same time is as beneficial as if they were administered separately. In addition to that study, Dr. Tseng published a study in 2011 in the Journal of the American Medical Association that found the shingles vaccine is associated with a fifty-five percent reduced risk of developing the disease. In 2010, another study by Dr. Tseng in JAMA found the pneumococcal pneumonia vaccination is not associated with a reduced risk of heart attacks or strokes in men.

Two Kaiser Permanente studies found that the combination vaccine for measles, mumps, rubella and chickenpox is associated with double the risk of febrile seizures for 1- to 2-year-old children, compared to same-day administration of the separate vaccine for MMR (measles, mumps, rubella) and the varicella vaccine for chickenpox. Other Kaiser Permanente studies found that children of parents who refuse vaccines are nine times more likely to get chickenpox and 23 times more likely to get pertussis (commonly known as whooping cough), compared to fully immunized children. Another study found that herpes zoster is very rare among children who have been vaccinated against chickenpox.

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Amylin Pharmaceuticals recently announced that it is participating in the fifth annual international Rare Disease Day to demonstrate the Company’s support for patients and families who are impacted by rare diseases. Celebrated around the world today, Rare Disease Day aims to raise awareness of the more than 7,000 known rare diseases and the effects of these diseases on patients’ lives, and to provide a platform of unity for rare disease patient communities.

In the U.S., a disease is considered rare, or orphan, if it affects fewer than 200,000 individuals. According to the National Institutes of Health Office of Rare Diseases Research, an estimated 25 to 30 million people in the U.S. have a rare disease. Most rare diseases have limited or no associated treatment options – and, to date, there are no known cures for these diseases.

“We are honored to participate in activities to draw heightened attention to rare diseases and the critical need to drive research to better understand these diseases and develop effective therapies for patients,” said Daniel M. Bradbury, president and chief executive officer of Amylin Pharmaceuticals.

“At Amylin, we are proud to be advancing the development of a potential therapy for rare forms of lipodystrophy, an ‘ultra-orphan’ disease. We believe all patients – whether they are impacted by one of the world’s most prevalent diseases, like type 2 diabetes, or one of the rarest – deserve better treatment options.”

Amylin launches disease awareness website – mylipodystrophy.com
To coincide with Rare Disease Day, Amylin also announced today the launch of mylipodystrophy.com, a disease awareness website that is dedicated to rare forms of lipodystrophy, and serves as a resource for information about the disease for patients, caregivers and healthcare providers.

People with lipodystrophy lack fat tissue. This can be partial, affecting select areas of the body, or generalized, affecting the entire body. The physical appearance of people with lipodystrophy can therefore vary considerably. Fat tissue is a major endocrine organ producing important metabolic hormones such as leptin.

A lack of functioning fat tissue can lead to relative deficiency of leptin. Without adequate leptin function, the metabolic system, which regulates food intake, energy storage, and energy production, falls out of balance. Fat accumulates in the blood or organs, which can lead to life-threatening complications including insulin-resistant diabetes, hypertriglyceridemia, acute pancreatitis and hepatic steatosis or steatohepatitis, also known as fatty liver disease.

There are no approved drugs to adequately treat the metabolic abnormalities that occur in lipodystrophy. To help raise public awareness of rare diseases, Amylin is also featuring a Rare Disease Day series on its corporate blog, Building Blocks, available at www.amylinbuildingblocks.com.

This series includes contributions from several experts in the rare disease field describing efforts underway to understand and combat rare diseases, as well as initiatives that are providing support for patient communities. Amylin is also participating in the Global Genes Project’s ”Wear that you Care” denim campaign, encouraging its employees to wear jeans to work today to show support for the rare disease cause.

Amylin is developing metreleptin as a potential treatment option for diabetes and/or hypertriglyceridemia in pediatric and adult patients with rare forms of lipodystrophy. The Company plans to complete the rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of this year.

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As the world’s largest professional society concerned with the causes and treatment of blood disorders, many of our more than 16,000 members are on the front lines of dealing with the country’s severe shortage of methotrexate, a drug critical in the treatment of children with acute lymphocytic leukemia (ALL).

The Food and Drug Administration (FDA) reported that two manufacturers plan additional releases within the week of February 20th, at the end of February, and continuing into March, which it anticipates will meet all patient needs.

While the Society is pleased with this announcement, we realize the shortage is still critical at many sites throughout the country and urge the FDA to ensure that once supplies are available, hematologists can have information on how to access this therapy for their critically ill patients.

ASH has been working hard to address the shortage, including reporting shortages to the FDA and Congress and urging the FDA to take immediate action to identify other manufacturers to meet demand, import supplies from overseas, and establish an emergency supply once there is a release so that supplies can be easily accessed.

Over the past year the Society has led collaborative efforts with the FDA, Congress, and senior health officials in the Administration to resolve not only this shortage, but also shortages of more than 200 other drugs, many of which are used to treat patients with hematologic diseases, that have become critical and life-threatening.

This week the Society sent a letter of support to Representatives Larry Buscon (D-IN) and John Carney (D-DE) who introduced bipartisan legislation (H.R. 3839, the Drug Shortage Prevention Act) that would provide expedite FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply.

The Society is also submitting comments this week to the FDA concerning its Interim Final Rule, issued in response to the President’s Executive Order of Oct. 31, 2011, to enable the FDA to improve its collection and distribution of drug shortage information.

The steps the Society has taken over the past year have had impact. Following the introduction of bills in the House and Senate last year (S. 296/H.R.2245, the Preserving Access to Life-Saving Medications Act) mandating early notification by manufacturers of drugs in short supply, ASH was the first medical society to call on Congress to conduct hearings and has made recommendations on ways to prevent and mitigate drug shortages that are being incorporated into legislative and regulatory proposals.

ASH will continue to monitor all hematologic drug shortages closely and will continue to work with policy makers to protect the health of Americans.

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A few weeks ago, the Food and Drug Administration hit the American Red Cross with a nearly $10 million fine for safety violations, lax oversight and faulty testing of its blood services. The fine is just the latest of more than a dozen the Red Cross has racked up in the last decade.

In 2003, a federal court, frustrated by repeated blood safety violations by the Red Cross, gave the FDA the power to fine the organization. Forty-six million dollars in penalties later, many of the same violations — understaffing, ineffective screening of donors, failure to recall infected blood — are outlined in the recent letter the FDA sent to the executive vice president of Biomedical Services for the Red Cross.

The 32-page letter describes hundreds of violations over several months in 2010 at 16 Red Cross facilities across the country, and details how the Red Cross repeatedly failed to properly track and record information about donors and blood units. (To see the actual document and others like it, go to our timeline of Red Cross fines.)

For example, the agency failed to notify health departments when donors had infectious diseases such as HIV and syphilis, failed to add new donors with infected blood to a national list of people who aren’t allowed to donate, and failed to review records of donors who had bad reactions, such as a 16-year-old who lost consciousness and fell to the floor after giving a unit of blood. It also failed to follow written procedures, such as the case of a phlebotomist in Arizona who stuck herself with a needle before sticking a donor with the same needle to draw blood. The case went unreported for a month, because a staff member “was not aware of the need to immediately notify a Medical Director,” according to the inspection letter.

In a recent statement, the Red Cross said it was disappointed that the FDA issued the fine for “an inspection conducted so long ago” and noted that it has “already taken corrective steps to address those matters and that improvements in operations have been made.”

In an email to ProPublica, a Red Cross spokeswoman also said there is no evidence that these violations endangered any patients, adding that the blood supply is safer than it has ever been. The spokeswoman said the agency has made significant improvements, including reducing the number of problems system-wide by at least 65 percent, and is investing in technology upgrades. For example, the agency recently upgraded software and computer equipment at blood drives to better collect and track donor information.

The FDA’s letter laying out the fines says the Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.” The FDA also noted that “many of the violations recounted in this letter are virtually identical to violations charged in previous [letters].” In June 2010 the FDA imposed a $16 million penalty on the Red Cross for the same type of violations.

The chronic problems raise the question of whether penalties are working at all.

The Red Cross has been making promises and failing to keep them for over a decade, according to Sidney Wolfe, who heads the health research group at the consumer watchdog organization Public Citizen. Wolfe said he wrote to head of the FDA in 2000, urging it to hold the Red Cross in contempt of court. A federal court first put the Red Cross under government supervision in 1993 after finding blood safety lapses. A decade later, in 2003, the court empowered the FDA to impose fines.

“But fast-forward nine years ahead, and we have the same violations,” Wolfe said.

If the Red Cross disagrees with an assessment, it can ask the FDA to reevaluate the penalty, but in most cases the fine only changes by a few thousand dollars.

Most of the recent problems inspectors cited have to do with managing records and tracking blood donors. The Red Cross says it is unaware of any infections or deaths that stemmed from problems noted in the report, and that “serious problems” account for only three percent of the total problems found.

The FDA doesn’t think that’s good enough.

“FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences,” said FDA spokeswoman Patricia El-Hinnawy.

The government requires that the Red Cross (like any blood services operation) have multiple safeguards for its blood services. That includes asking a donor questions to identify any risks, checking his or her name against a national list of people who aren’t allowed to give blood, testing for infectious diseases, keeping track of blood units so infected blood isn’t released, and investigating any deviations from standards.

Because blood transfusions always carry a degree of risk, the FDA considers every step in that process critical to minimizing problems. “Failure of an individual safeguard does not automatically translate into the release of unsafe products,” an FDA spokeswoman told ProPublica in an email, “however, it may increase the potential for risk.”

In 2008, the Red Cross consolidated its blood work to two facilities: one in Charlotte, N.C., and the other in Philadelphia. The offices are in charge of managing, tracking and, if need be, recalling blood. But according to the inspection letter, both offices have been chronically understaffed, and simply haven’t been able to carry out their required functions in a timely or effective manner. As of 2010, the offices had a backlog of about 18,000 donor management cases.

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by Lena Groeger ProPublica, Feb. 2, 2012, 8:27 a.m.by Lena Groeger, ProPublica, Feb. 1

Image Courtesy of  littleny / Shutterstock.com

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The U.S. Food and Drug Administration has approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation.

“Kalydeco is an excellent example of the promise of personalized medicine – targeted drugs that treat patients with a specific genetic makeup,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development.”

The FDA reviewed and approved Kalydeco in approximately three months under the agency’s priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.

Kalydeco was approved ahead of the drug’s April 18, 2012, prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.

In patients with the G551D mutation, Kalydeco, a pill taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of CF such as increasing weight gain.

“Kalydeco is the first available treatment that targets the defective CFTR protein, which is the underlying cause of cystic fibrosis,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease.”

Two 48-week, placebo-controlled clinical studies involving 213 patients, one in patients ages 12 years and older and another in patients ages 6 years to 11 years, were used to evaluate the safety and efficacy of Kalydeco in CF patients with the G551D mutation. In both studies, treatment with Kalydeco resulted in significant and sustained improvement in lung function.

Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient’s mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

The most common side effects of Kalydeco include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness.

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Recently, Erivedge was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Erivedge, reviewed under the agency’s priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma. Erivedge was reviewed under the FDA’s priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment. The drug is being approved ahead of the March 8, 2012, prescription user fee goal date.

Basal cell carcinoma is generally a slow growing and painless form of skin cancer that starts in the top layer of the skin (epidermis). The cancer develops on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.

Erivedge is a pill taken once a day and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.

“Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.”

The safety and effectiveness of Erivedge was evaluated in a single, multi-center clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma.

The clinical study’s primary endpoint was objective response rate (ORR) or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment. Of the patients with metastatic disease receiving Erivedge, 30 percent experienced a partial response and 43 percent of patients with locally advanced disease experienced a complete or partial response.

The most common side effects observed in patients treated with Erivedge were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.

Erivedge is being approved with a boxed warning alerting patients and health care professionals of the potential risk of death or severe birth effects to a fetus (unborn baby). Pregnancy status must be verified prior to the start of Erivedge treatment. Male and female patients should be warned about these risks and the need for birth control.

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��P�� lse’s mistake. “Tattoo Nightmares” is created by Sally Ann Salsano (“Jersey Shore”) and 495 Productions.

“Rat Bastards” – An invasive species of giant swamp rats are ravaging America’s Southern wetlands and are especially dangerous to the tenuous ecological system of the Mississippi delta region.  This non-scripted series follows a pack of industrious guys dubbed the “Cajun Commandoes” in Louisiana who hunt these elusive 40-pound menaces both to sell and to eat.

These determined rat hunters compete over a limited four month window to earn big bucks by capturing these loathsome pests for a bounty.  The series is co-created by Eli Holzman and Stephen Lambert of Studio Lambert and Royal Malloy, Duke Straub andColt Straub of American Chainsaw. They are also the production team behind the upcoming Spike series, “Diamond Divers.”

Spike will also create new episodes of “World’s Wildest Police Videos,” which will give viewers access to shocking and outrageous police footage never-before-seen on television.  From high-speed car chases that turn deadly and bank robberies gone wrong to international hostage holdups, the wildest police videos from around the world are on display.

Retired Sheriff John Bunnell hosts the series that is produced by Pilgrim Studios and Pursuit Productions. Executive Producers are Pilgrim Studios’ Craig Piligian andScott Popjes, and Pursuit Productions’ Paul Stojanovich, Jr., Robert Ballantyne and John Bunnell.  The original version was created by Paul Stojanovich Sr. and aired on FOX from 1998-2002.

Spike will air a two-part special, “Urban Jungle Man,” which follows the country’s preeminent extreme animal handler, John Brennan, who rescues, captures and relocates dangerous and exotic animals in New York City’s urban jungle. This non-scripted series chronicles Brennan’s daily adventures as he runs the Urban Animal Relocation team, a privately-owned exotic and dangerous animal relocation service whose perilous missions runs the gamut from removing an alligator from a bathtub to capturing an escaped deadly python.  

Bitten or stung by nearly every animal in existence, Brennan is fearless when it comes to apprehending nature’s deadliest creatures.  “Urban Jungle Man” is produced by Asylum Entertainment and will be shot throughout the country.

Image Courtesy of   http://www.flickr.com/photos/christianacare/

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The Food and Drug Administration (FDA) approved a new drug, Horizant Extended Release Tablets, on Wednesday to treat moderate to severe primary Restless Legs Syndrome in adults.  Horizant is a patented new chemical entity discovered and developed by both GlaxoSmithKline and XenoPort.

Restless Legs Syndrome affects up to 10 percent of the U.S. population and is a disorder of the nervous system that causes an urge in the body to move one’s legs.  This disorder is classified as a sleeping disorder because it affects and interferes with a person’s sleeping habits.  The irresistible need to move one’s legs in attempt to relieve the sensations is often described as uncomfortable, “pins and needles,” or a “creepy crawly” feeling.  The sensations are often made worse when laying down, sitting or when legs are trying to rest.

“People with Restless Legs Syndrome can experience considerable distress from their symptoms,” Russell Katz, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, states in an FDA news release.  “Horizant provides significant help in treating these symptoms.”

The drug was approved based on two studies that were done in more than 2,300 adults.  These 12-week studies showed improvement in Restless Legs Syndrome patients trying Horizant that was considerably greater than those patients who were receiving a placebo.  Patients received oral daily doses in a range from 600 to 3,600 mg.

According to the full Prescribing Information provided on Horizant’s website, the recommended doze of this drug is 600 mg once daily taken with food.  The drug is not to be cut, crushed or chewed. Horizant is a prodrug of gabapentin and is described as an acetic acid.  It’s molecular formula is C16H27NO6.

This drug is administered orally and contains 600 mg of gabapentin enacarbil and the following other inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, glyceryl behenate, magnesium sterate, sodium lauryl sulfate, and talc.

The FDA states that Horizant “may cause drowsiness and dizziness and can impair a person’s ability to drive or operate complex machinery.”  Horizant’s website also confirms that this drug causes significant driving impairment.  It is an antiseizure medicine, and like all drugs of this type, Horizant holds a warning label about the risk of suicidal thoughts and actions in a small number of people.

According to a news release from GlaxoSmithKilne and XenoPort, do not take Horizant if you sleep during the daytime and remain awake at night.

This is a significant milestone in XenoPort and GlaxoSmithKline’s efforts to develop a non-dopaminergic therapy.  “We hope that we can continue to develop other important medicines that can provide meaningful treatment benefit to sufferers of central nervous system disorders,” Ronald Barett, CEO of XenoPort said.

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Picture Audrey Hepburn, the beautiful, classy movie star, sitting to eat (perhaps breakfast?), walking through a crowded party or sitting in the backseat of a car.  What is the consistent image?  Take a look at the 1961 film classic Breakfast at Tiffany’s, where Hepburn plays Holly Golightly, a role she called “the jazziest of my career.”  What is the one thing that is undeniably classy and memorable about her role in this and other films?  It is her extra long cigarette holder.  How was the iconic Hepburn, or Humphrey Bogart in Casablanca and other classic “Bogie” films, as well as many, many other movie stars of the golden era of Hollywood, allowed to be shown smoking in public virtually anywhere they desired?  They, and the public at large, were unaware of the dangers of smoking.  The deadly dangers.

Now, you can sit down to dinner or cozy up at your favorite bar and channel your inner Audrey Hepburn.  Heads might turn, but you will be completely within legal limits.  Cigarettes indoors, in public?  How can that be?  It might not be at the end of an extra long cigarette holder, like the one Hepburn favored, but it will be completely healthy and harmless.  Electronic cigarettes are the newest trend, and a very good one at that.  What better way to quit smoking than to continue going through the motions without any actual tobacco intake?  Well, as long as it’s an e-cigarette, you can.

According to a study conducted by the American Heart Association, approximately 25.6 million men and 22.6 million women in the United States are smokers.  Would many of these Americans quit smoking if it wasn’t a constant, difficult struggle to do so?  Sources say yes.

E-cigarettes are the new electronic smoking alternative that look and feel like real cigarettes, and allow smokers to get the sensation of smoking without any tobacco.  E-cigarettes have no carcinogens.  Instead of burning tobacco or a comparable smoking product, the e-cigarette atomizes a liquid into a tar-free and odorless vapor.  It is up to the smoker whether the cigarette’s liquid contains nicotine or not.

The device is a battery-operated, long-shaped tube.  Most of these cigarettes mimic the appearance of a cigarette or cigar, giving the e-cigarette the most authentic look possible.  Others look like a ballpoint pen (biros).  While there are disposable e-cigarettes on the market, the majority are reusable and come with replaceable and refillable cartridges.

An electronic cigarette is broken down into several components.  The mouthpiece, often referred to as the cartridge, is fixed to the end of a tube.  There is a small cup inside the mouthpiece that contains an absorbent material that is drenched in a liquid.  This liquid contains varying levels of nicotine, if any at all.  The cartridge can be refilled or replaced once it’s empty.

The cartridge contains a liquid referred to as e-liquid.  The e-liquid can contain hundreds of flavors, including menthol.  For smokers who want nicotine, they can get an e-liquid containing nicotine that has been dissolved in propylene glycol or vegetable glycerin — both common food additives.  According to the Food and Drug Administration (FDA) propylene glycol and vegetable glycerin are recognized as one of its GRAS (Generally Recognized as Safe) substances.  There are no known serious side effects with these ingredients and they have been used since the 1950s inside nebulizers and asthma inhalers.

The battery in most e-cigarettes is a lithium-ion battery and is rechargeable.  The battery powers the heating element, called an atomizer, and allows the liquid to heat up and vaporize.  Once vaporized, the liquid can be breathed in — inhaled.

In addition to the cartridge, there can also be a cartomizer.  A cartomizer is a one piece unit combining the cartridge with the atomizer.  It is screwed into the battery and used only once.  It is meant to be disposed of afterward, although, some people do refill them.  Cartomizers are the optimum choice for beginners because the cartomizers are sold prefilled with the flavor of choice.

The newest versions of e-cigarettes have a sensor that automatically starts the heating method when the device is sucked on.  Older versions use a button that needs to be pressed in during inhalation.  Most versions, especially the newer ones, have an LED, light emitting diode, that lights up when the device is made active to simulate the burning tip of a cigarette.

More research needs to be conducted, however, to test the safety of electronic cigarettes.  The FDA has refused some entry of shipments of these products coming into the United States since the components of e-cigarettes have not yet been tested for safety.  E-cigarette buyers will have to provide customs with a letter explaining the electronic cigarettes are for personal use.  “We basically don’t know anything about them [e-cigarettes],” Dr. Richard D. Hurt, director of the Nicotine Dependence Center at the Mayo Clinic said.  “They’ve never been tested for safety or efficacy to help people stop smoking.”

All the same, e-cigarettes are the latest trend and can even be seen on the big screen.  Johnny Depp “smokes” electronic cigarettes in the film “The Tourist.”  Depp plays Frank, an American tourist in Italy, who meets Elise (Angelina Jolie).  Depp’s character explains the benefits of e-cigarettes throughout the movie to Angelina Jolie’s character.  On a much smaller screen, e-cigarettes have been seen on the Real Housewives of Beverly Hills.

Whatever your motivation for trying out electronic cigarettes, it should be acknowledged that the choice to move toward a tobacco-free lifestyle is a difficult, but important decision.  E-cigarettes can, and have, helped smokers quit completely.  When reformed smokers feel a nicotine craving, they can “light up” an e-cigarette, feel the simulated sensation, and curb the craving.

Since e-cigarettes produce no second hand smoke, your neighbors and friends will be happy that you chose the alternative method of smoking.  Smokers will no longer have to struggle with the health and social stigmas associated with smoking.  One day, they will not have to struggle with smoking at all.

For now, sit down at your favorite bar, take out your electronic cigarette and try to remember how Hepburn did it.  You might get some unwelcome, uneducated glares, but let that be your cue to start educating others.

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The first new drug to treat Lupus Erythematosus in more than 50 years was approved this month by the U.S. Food and Drug Association (FDA).  Lupus is a chronic, inflammatory, multi-system disorder of the immune system, which causes fibrous tissue and inflammation of internal organs, skin rashes and joint pain.  A facial rash that resembles a wolf bite often accompanies lupus and is what gave the disorder it’s name, lupus meaning “wolf” and erythematosus meaning “redness.”

The new drug, Belimumab (Benlysta), is an injectable drug that was designed to relieve flare-ups and pain.  Benlysta was created — after 15 years of development — by Human Genome Sciences Inc. and GlaxoSmithKline PLC.  The drug is a monoclonal antibody that targets the B-lymphocyte stimulator protein (BLyS).  According to the FDA, this is the first drug designed to target a protein that may reduce the number of abnormal B cells believed to be at the root of lupus.

“Benlysta, when used with existing therapies, may be an important new treatment approach for healthcare professionals and patients looking to help manage symptoms associated with this disease,” said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The last drugs to be approved by the FDA for lupus was Plaquenil (hydroxychloroquine), a malaria drug, and corticosteroids in 1955.  Before that, aspirin was approved as a treatment.

Benlysta was approved by the FDA after an advisory committee of independent experts voted 13-to-2 in November to recommend its approval.  At that time, there was some reservations about the effectiveness of the drug.  Most of the drug’s benefit came from relieving muscle inflammation, not organ problems.

A clinical study showed that Benlysta, after one-year of monitoring response rates, was more effective than placebo.  In the study, to be credited with a response, patients had to have at least a four-point improvement in SELENA-SLEDAI score, have no increase in Physician Global Assessment scores of 0.3 points or more, and have no new flares meeting the British Isles Lupus Assessment (BILAG) 1A-2B standard.  That being said, a relatively small proportion of patients met the study’s criteria for a response after one year (43% with the drug vs. 32% with the placebo).

More clinical trials need to be conducted with Benlysta because thus far the drug has been shown to be less effective in African Americans — who are twice as likely as Caucasians to be diagnosed with lupus.  Studies to date were not extensive enough to make any conclusions about whether the drug will be ineffective for all African Americans or not.  Also, the new drug was not effective for any trial patients with the deadliest form of lupus.

Benlysta, even though only modestly effective, should provide encouragement that after more than 50 years of no new approved drugs, there is still a future for drug advancement for lupus.  The drug “will send out the message that it’s possible to conduct a successful clinical trial in lupus and that’s tremendously important to keep the pharmaceutical industry interested in this disease,” Dr. Betty Diamond, a researcher at the Feinstein Institute in New York said.

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