Health-Medical-Fitness-Diet-zv: 2012

duminică, 2 septembrie 2012

Can drug coverage erase the income gap in diabetes?

Researchers found that much of the income gap in heart risks among diabetic adults disappeared after the age of 65 - the age at which universal drug coverage kicks in for Canadians.

Canada has universal healthcare, but when it comes to medications, people younger than 65 either pay out-of-pocket or have private drug coverage through work - similar to Americans their age.

In the new study of more than 600,000 Ontario residents with diabetes, researchers found that lower-income people had higher risks of heart attack, stroke and death. But the disparity largely disappeared after age 65.

The findings, reported in the journal Diabetes Care, do not prove that universal drug coverage erased the income gap.

But there is no other obvious factor that would explain the "sudden shift" at age 65, said lead researcher Dr. Gillian L. Booth, of the University of Toronto and St. Michael's Hospital in Ontario.

"This also fits in with what's been seen in other studies," Booth said in an interview.

Research has shown that a growing number of people with diabetes cannot afford their medications - which include not only drugs to control blood sugar, but also those for high blood pressure, high cholesterol and other problems that commonly go hand-in-hand with diabetes.

Another study in Ontario also found a widening gap in death rates between the rich and poor with diabetes - but the trend is mainly among people younger than 65.

"I feel confident that expanding drug coverage could help save some lives," Booth said.

Her team's findings are based on health records for 606,051 Ontario adults who were followed over six years. During that time, over 48,000 of those people were hospitalized for a heart attack or stroke, and just over 111,000 died of any cause.

Booth's team found that among people younger than 65, those in the bottom 20 percent for income had a higher rate of heart attack, stroke and death: just over two percent per year, versus 1.4 percent among the wealthiest 20 percent.

Even when the researchers considered certain other factors - like people's history of heart problems before the study - low income was still linked to a 51 percent higher risk.

But when the researchers looked at older adults, the gap between the rich and poor was much smaller: the lowest-income group had a 12-percent higher risk of heart attack, stroke or death than the most affluent group.

Even though Booth thinks universal drug coverage helps explains the findings, she said it is not the sole reason for the gap between the rich and poor.

"It's more complicated than that," Booth said. Diabetes is a complex condition that requires people to keep up a healthy lifestyle, and tackle daily tasks like measuring blood sugar.

So differences in diet, exercise, smoking and general "health literacy" - a person's ability to read and understand information about a health condition - are all important, according to Booth.

"Drug coverage is one piece," she said. "We think it's an important piece, but it's not the only one."

Booth also said she thinks her findings are relevant to other countries, including the U.S., where the Medicare program for older Americans has covered the cost of prescriptions since 2006.

Studies have shown that since that benefit started, Medicare recipients' adherence to their medications has generally improved. That includes the poorest and sickest beneficiaries.

Those studies have also found that "non-drug" spending - mostly for hospitalizations - has declined among Medicare recipients who previously had only limited drug coverage.

Medicare drug coverage is subject to coverage gaps, in which seniors have to pay full price for their prescriptions. Recent studies have found that participants often drop their medications when they hit that so-called "donut hole" in coverage, but have not documented any health consequences from that choice. (See Reuters Health stories of July 2, 2012 and August 17, 2012.

Still, Booth said the overall evidence argues for better drug coverage for younger people as well. "More and more people are being diagnosed with diabetes at younger ages," she noted.

Older age is a major risk factor for type 2 diabetes, by far the most common form of diabetes. But so is obesity. And in the U.S., about 36 percent of all adults are now obese.

An estimated 26 million Americans have diabetes, including 14 percent of all people between the ages of 45 and 64, according to the Centers for Disease Control and Prevention.

SOURCE: http://bit.ly/RLDmqT Diabetes Care, online August 13, 2012.

FDA approves Medivation prostate cancer drug

Approval of the pill, to be sold under the brand name Xtandi, comes three months ahead of the agency's late-November decision deadline and sent shares of Medivation up 7.6 percent.

Wall Street analysts, on average, have forecast Medivation's sales of the drug at $1.2 billion by 2017, according to Thomson Pharma.

Xtandi, or enzalutamide, is one of a new class of drugs known as androgen inhibitors, designed to interfere with the ability of testosterone to bind to prostate cancer cells. Testosterone is the male hormone that fuels prostate cancer cell growth.

Medivation said it would begin selling the drug in the United States in mid-September at a wholesale price of $7,450 for a 30-day supply. Trial patients, on average, used the drug for eight months, the company said.

Medivation and Astellas, which have also filed for European approval, reported in November that a pivotal study of the drug had been stopped early after it became clear that it improved median overall survival by 4.8 months compared with a placebo.

The pill is also being tested in men with earlier stage prostate cancer, but Medivation has not said when those results are expected.

"The real opportunity for Xtandi is in pre-chemotherapy," Sanford Bernstein analyst Geoffrey Porges said in a research note.

He estimated that 18,000 to 20,000 U.S. prostate cancer patients receive chemotherapy every year and 4,000 to 5,000 eventually progress to other treatments.

"I am confident that this is only the beginning of success stories with this agent and that it will be used in earlier stages of prostate cancer in the near future," Dr. E. David Crawford, head of the urologic oncology department at the University of Colorado Health Sciences Center and chairman of the Prostate Conditions Education Council, said in a statement.

The FDA last year approved Johnson & Johnson's Zytiga, which is designed to work inside cancer cells to block testosterone production.

"The need for additional treatment options for advanced prostate cancer continues to be important for patients," Richard Pazdur, director of hematology and oncology products at the FDA's drug evaluation and research center, said in a statement. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."

Xtandi "should have comparable or higher sales than Zytiga because it appears to have superior efficacy and had no serious adverse events in clinical trials," said ThinkEquity analyst Kimberly Lee.

Zytiga's worldwide sales rose about $32 million to $232 million in the second quarter from the first quarter.

Prostate cancer kills about 250,000 men a year globally and is the second most common cause of cancer death in men in the United States, after lung cancer.

The most common side effects seen with Xtandi were weakness, fatigue and back pain. The FDA said seizures occurred in about 1 percent of patients and they were taken off the therapy.

The FDA required that Medivation conduct a post-marketing study to further determine the seizure risk of Xtandi.

Medivation said the FDA approval and European regulatory filing trigger milestone payments from Astellas of $35 million, 10 percent of which it is obligated to pay to the University of California, Los Angeles under a licensing agreement.

Shares of Medivation gained $7.44, or 7.6 percent, to $104.86 on Nasdaq.

Shares of Japan-based Astellas closed down less than a percentage point at 3,820 yen in Tokyo, ahead of the announcement.

(Additional reporting by Ransdell Pierson and Michele Gershberg; Editing by Leslie Gevirtz, Tim Dobbyn and Dan Grebler)

German drug firm makes first apology for thalidomide

Gruenenthal Group's chief executive said the company wanted to apologize to mothers who took the drug during the 1950s and 1960s and to their children who suffered congenital birth defects as a result.

"We ask for forgiveness that for nearly 50 years we didn't find a way of reaching out to you from human being to human being," Harald Stock said. "We ask that you regard our long silence as a sign of the shock that your fate caused in us."

Stock spoke in the west German city of Stolberg, where the company is based, during the unveiling of a bronze statue symbolizing a child born without limbs because of thalidomide. The statue is called "the sick child" — a name German victims group object to since all the victims are now adults. In German, the name also implies cure.

The drug is a powerful sedative and was sold under the brand name Contergan in Germany. It was given to pregnant women mostly to combat morning sickness, but led to a wave of birth defects in Europe, Australia, Canada and Japan. Thalidomide was yanked from the market in 1961 and was also found to cause defects in the eyes, ears, heart, genitals and internal organs of developing babies.

Thalidomide was never approved for use in pregnant women in the United States.

Freddie Astbury, of Liverpool, England, was born without arms or legs after his mother took thalidomide. The 52-year-old said the apology was years long overdue.

"It's a disgrace that it's taken them 50 years to apologize," said Astbury, of the Thalidomide U.K. agency, an advocacy group for survivors. "I'm gobsmacked (astounded)," he said. "For years, (Gruenenthal) have insisted they never did anything wrong and refused to talk to us."

Astbury said the drug maker should apologize not just to the people affected, but to their families. He also said the company should offer compensation. "It's time to put their money where their mouth is," he said. "For me to drive costs about 50,000 pounds ($79,000) for a car with all the adaptations," he said. "A lot of us depend on specialist care and that runs into the millions."

Astbury said he and other U.K. survivors have received some money over the years from a trust set up by thalidomide's British distributor but that Gruenenthal has never agreed to settle.

"We invite them to sit around the table with us to see how far their apology will go," he said. "I don't think they've ever realized the impact they've had on peoples' lives."

Gruenenthal settled a lawsuit in Germany in 1972 — 11 years after stopping sales of the drug — and voiced its regret to the victims. But for decades, the company refused to admit liability, saying it had conducted all necessary clinical trial required at the time.

Stock reiterated that position Friday, insisting that "the suffering that occurred with Contergan 50 years ago happened in a world that is completely different from today" and the pharmaceutical industry had learned a valuable lesson from the incident.

"When it developed Contergan Gruenenthal acted on the basis of the available scientific knowledge at the time and met all the industry standards for the testing of new drugs that were known in the 1950s and 1960s," he said.

A German victims group rejected the company's apology as too little, too late.

"The apology as such doesn't help us deal with our everyday life," said Ilonka Stebritz, a spokeswoman for the Association of Contergan Victims. "What we need are other things."

Stebritz said that the 1970 settlement in Germany led to the creation of a €150 million fund for some 3,000 German victims, but that with a normal life expectancy of 85 years the money wasn't enough. In many other countries, victims are still waiting for compensation from Gruenenthal or its local distributors.

In July, an Australian woman born without arms and legs after her mother took thalidomide reached a multimillion dollar settlement with the drug's British distributor. Gruenenthal refused to settle. The lawsuit was part of a class action and more than 100 other survivors expect to have their claims heard in the next year.

Attorneys for Lynette Rowe said in a statement released Saturday that Grunenthal's apology rang hollow.

"To suggest that its long silence before today ought to be put down to 'silent shock' on its part is insulting nonsense," the statement reads. "For 50 years Grunenthal has been engaged in a calculated corporate strategy to avoid the moral, legal and financial consequences of its reckless and negligent actions of the 1950s and 1960s."

Thalidomide is still sold today, but as a treatment for multiple myeloma, a bone marrow cancer and leprosy. It is also being studied to see if it might be useful for other conditions including AIDS, arthritis and other cancers.

___

Associated Press writers Maria Cheng in London and Kristen Gelineau in Sydney contributed to this report.

vineri, 31 august 2012

Man Fractures Penis After Taking Sex Pill, Lawsuit Claims

But though Adrian Carter of Texas blames the supplement, three urologists told ABCNews.com com that penile fractures are most often the result of rough sex.

Adrian Carter of Texas said he purchased VirilisPro in the "early morning hours" at a Chevron gas station en route to the Scottish Inn, where he had sex with his "paramour," according to the lawsuit.

Later, during intercourse, he had "significant pain and observed a large quantity of blood squirting out of his penis onto the sheets, walls and mirror," according to the lawsuit filed Aug. 27 in the district court of Harris County, Texas.

Emergency room doctors had to "deglove" Carter's penis in order to repair it, rendering him unable to have sex or future children, Carter claimed.

The lawsuit said VirilisPro was "defective and unreasonably dangerous for use by consumers."

"It was pretty horrific to view the pictures," Carter's lawyer, Melissa Moore, told ABCNews.com. "I know it sounds unusual. ... He was young and healthy and on no other meds at the time he took the supplement."

Named in the lawsuit were the drug manufacturer, Haute Health Limited Liability Company, Carney & Carney Financial Services, individuals Michael Heilig and Michael and Tyra Carney, and Solid Rock Worship Company, all located in New Jersey.

ABCNews.com was unable to reach any of the defendants for comment.

Carter is seeking medical expenses and punitive damages for product liability, negligence, breach of warranty, deceptive trade, mental anguish, pain and suffering and "past and future loss of consortium."

He alleged that when he purchased the supplement, the store clerk suggested the product as "natural and safe."

Carter's doctor, who is continuing follow-up treatment, "directly linked" the penis injury to the supplement, Moore said.

But urologists said penile fractures usually are caused by traumatic sexual intercourse.

And they are fairly common, according to Dr. Chad Ritenour, associate professor of urology at Emory University School of Medicine in Atlanta. He sees a case -- called "eggplant penis" -- at least once a month.

"I never heard of anyone being put at a higher risk for fracture because of a prescription or an herbal drug," said Carney. "With a fracture, you typically get swelling and the penis looks like an eggplant -- purple and swollen. But blood coming out on the walls, that sounds really dramatic.

"The typical story is that someone is having intercourse and, in the course of an erection, they miss an opening and hit a pelvic bone in their partner," he said. "In the classic case, you hear a 'pop' and feel something immediately."

Carter said he was taken to a local emergency room, where the doctor diagnosed him with "gross hematuria" -- blood in his urine -- as well as penile fracture and a urethral injury, according to the lawsuit.

There, after "initial exploratory surgery," doctors allegedly "degloved," or removed the skin from the penis, and repaired his urethra, which had "separated completely."

Carter was released from the hospital after a few days, but a catheter remained in place for three days, according to the lawsuit.

"Doctors again warned him that he may never have an erection or be able to father children and his ureters may close, resulting in permanent inability to urinate naturally," according to court papers.

Dr. Jeanne O'Brien, an associate professor of urology and male fertility, said penile fractures can traumatize the urethra.

"They often happen together and it is routine to clear the urethra in cases of penile fracture," she wrote in an email to ABCNews.com. "Surgical repair is the only option in these cases."

Surgery can cause permanent erectile dysfunction, obstruction of the urethra and, rarely, urinary incontinence and "retrograde ejaculation," she said.

According to its website, VirilisPro is a supplement to improve sexual performance that "works to give you a harder erection for natural male enlargement and a more intense orgasm. It also helps lower your recovery time and increase sexual stamina for total sexual enhancement."

Its online advertising says that the product is "made with only natural ingredients to prevent harmful side effects." Its ingredients are listed as a 450 mg "proprietary blend" of epimedium, tribulus terrestris, panax ginseng, rhodiola rosea, lycium chinese and yohimbe extract.

Male consumers are instructed to take it 30 minutes before intercourse and only use one pill in a 36-hour period. The ad warns the user to "always check with a healthcare professional" first.

The Food and Drug Administration does not regulate dietary supplements in the same ways they do food and drugs. The dietary ingredient manufacturer is responsible for ensuring that it is safe before marketing it. The FDA can take action against any unsafe supplement, according to their guidelines.

Alleging that supplements caused penile fracture is "the most absurd thing I have heard of in my life," according to Dr. Jeff Carney, chief of urology at Grady Memorial Hospital and a trauma specialist.

Some of Carter's symptoms as described in the court papers ring true -- pain and swelling, according to Carney, but other details are "overly dramatic," he said.

Degloving would never have been done in an emergency room, but by a skilled surgeon, he said. If the urinary channel is also affected by the fracture, the injury can be bloody, but "blood squirting out helter skelter" is not possible, "I can guarantee you," he said.

"When a man breaks his penis it can be very scary," said Carter. "I believe he took this story and spiced it up."

Carney said that he has heard "everything under the sun" when men arrive in the emergency room with a fractured penis. "The most common one told is they walked into an ironing board."

"I suppose it's possible you could get up in the middle of the night with a hard erection and a walk into a wall and break your penis," he said.

Urologist Ritenour agreed.

"You never know if you are getting the real story," he said. "People are embarrassed. The real point of this story is that this is a medical emergency and you really need to come and be seen so it can be handled surgically and fixed."

Pig parasite may help treat autoimmune disorders

The team at Coronado Biosciences Inc is betting you would.

The Burlington, Massachusetts, company is developing what it hopes will be the first in a new class of treatments for autoimmune conditions. Each dose of the drug consists of thousands of microscopic parasite eggs, culled from pig feces, suspended in a tablespoon of saline solution to be swallowed.

In a pig, the eggs would grow into mature whipworms and reproduce, without harming their host. In humans, the same eggs barely survive two weeks. Yet in that short period they appear to modulate a patient's immune system and prevent it from attacking the body's own tissues and organs.

"It has the potential not only to be a drug but to provide insight into the cause of these diseases," said Dr. Joel Weinstock, chief of gastroenterology and hepatology at Tufts Medical Center in Boston and an adviser to Coronado.

The company is preparing to enroll 220 patients with Crohn's disease in a midstage clinical trial. Participants will receive either a dose with 7,500 eggs from a pig whipworm or a placebo once every two weeks for 12 weeks.

Coronado's partner, German drugmaker Dr. Falk Pharma GmbH, is conducting a midstage trial of the drug, known as trichuris suis ova (TSO), in Europe. The two companies plan to share data when filing for marketing approval in 2016 or 2017.

Tiny Coronado, with a market value of nearly $139 million, went public on the Nasdaq stock exchange last December. If the company, which also has an early-stage cancer drug in development, succeeds with TSO, it will compete against multibillion-dollar drugs from Amgen Inc and Abbott Laboratories.

Sales of autoimmune disease drugs are expected to grow in the mid-single-digit percentages through 2016, from $34 billion in 2010, according to market research firm BCC Research.

As many as 700,000 Americans suffer from Crohn's disease, a bowel disorder. At least 1.3 million Americans have rheumatoid arthritis and as many as 7.5 million suffer from psoriasis.

HYGIENE HYPOTHESIS

The technology behind Coronado's product was developed by Weinstock and researchers at the University of Iowa, where Weinstock was affiliated before Tufts. It is based on the "hygiene hypothesis," which holds that many developed countries have, in some ways, become too clean for their own good.

Millions of organisms, including viruses, bacteria and worms, enter the body through contact with dirt. Researchers believe many of these organisms are needed to train the body's immune system to recognize and fight disease.

"Microbes have adapted to us, and us to them, and we use them to stimulate our immune system," said Dennis Kasper, a professor of medicine, microbiology and immunobiology at Harvard Medical School, who is not involved with Coronado's product.

Today in many parts of the world these organisms are kept at bay with an array of antibacterial soaps, detergents and sanitizing gels.

Studies have shown that the incidence of autoimmune disease tends to be highest in the developed world, and is highest there among upper-income groups. Weinstock and others hypothesize that the elimination of certain intestinal parasites may have led to the loss in some individuals of a key mechanism for modulating the immune system.

Standard treatments for autoimmune disorders include injectable drugs that block a protein known as tumor necrosis factor. They include Amgen's Enbrel and Abbott's Humira. These depress the immune system and send its army of infection-fighting cells back to their barracks.

They also raise the risk of serious infection, including tuberculosis, and some types of cancer. Coronado's chief executive officer, Bobby Sandage Jr., says that is one reason why patients with serious conditions would choose the company's drug despite its provenance.

"With the pig whipworm, there is no permanent infection, no real possible side effects," he said.

Sandage said about a third of patients experience some gastrointestinal discomfort, such as diarrhea or cramping, after the first or second dose, though the symptoms typically go away after a day or two. He said patients need to stay on the drug indefinitely to keep symptoms at bay.

"It really does take a bit of getting used to. But once you talk to patients and they understand the theory, they accept it. We have had no trouble recruiting," said Dr. John Fleming, a professor of neurology at the University of Wisconsin who is testing the drug in patients with multiple sclerosis.

Others are skeptical about the drug's chances of gaining broad acceptance.

"This is not like taking a pill or even an injectable," said Steve Brozak, an analyst at WBB Securities who follows the biotechnology sector. "Here you are taking parasites that live in a pig's intestine, putting them into little vials and saying, 'Bottoms up!'"

COMFORTABLE COEXISTENCE

Humans and their parasites have evolved in tandem for millennia. Most parasites have found ways to feed off humans without killing them, and some have become important for health.

A parasite that lives comfortably in humans may not be able to survive in another species, and vice versa. For the purpose of creating a drug, that is a good thing.

"What we know from the pig whipworm is that when you give it to people, it is destroyed in the gut," said Fleming. "It doesn't come out, so you have to keep giving it."

Initial results from early trials of the drug in patients with multiple sclerosis are promising, he said, though much more study will be needed to prove efficacy.

"I'm pretty convinced about the safety," he said.

Coronado has rights to the drug for all autoimmune conditions in North America, South America and Japan. Dr. Falk holds the rights to market the drug for gastrointestinal disorders in Europe.

By next summer, 250 people in the Phase 2 Falk study will have taken the drug for three months, and data is expected to be released around the same time. Results from Coronado's study should be released in the second half of next year.

Approval from regulators could involve an unusual set of hurdles, as there is little precedent for such a product. Sandage said conversations with the U.S. Food and Drug Administration and European regulators are going well.

"They are very well aware of what the product is, and we have been through a lot of stuff with them and they seem very happy so far," he said.

New systems have had to be introduced to clean the eggs. Traditional biologic drugs are purified using high heat or radiation, but Coronado can't do that: It needs the eggs to stay alive. So the company uses an acid wash, which the eggs can withstand because they have evolved to pass through the stomach acid of their host.

"A lot of time was spent figuring out purification techniques," Sandage said.

(This August 24 story has been corrected to fix name of Tufts Medical Center in paragraph five)

(Editing by Michele Gershberg and Douglas Royalty)

Study Uncovers Alarming Worldwide Rates of Drug-Resistant TB

The trend is becoming worrisome, enough so that researchers from the Centers for Disease Control and Prevention undertook a study of resistance rates and causes among 1,278 patients with multi drug-resistant TB in eight countries: Estonia, Latvia, Peru, the Philippines, Russia, South Africa, South Korea and Thailand. Samples were tested for resistance to 11 first- and second-line drugs. The findings were published this week in The Lancet.

Overall rates were alarming: almost 44 percent of all patients were resistant to at least one second-line drug, and 20 percent were resistant to at least one second-line injectable drug. Results varied widely by country. About a third of Thai patients and 62 percent of Latvian patients showed resistance.

MORE: Smoking Rates Around the World Are Astronomical

Among all patients, 6.7 percent were considered extensively drug-resistant, or XDR, a step up from multi drug-resistant, or MDR. MDR patients are resistant to at least two first-line drugs, isoniazid and rifampicin, while XDR patients are resistant to isoniazid, rifampicin, a fluoroquinolone (an antibiotic) and a second-line injectable drug. It follows that XDR TB patients have fewer options for treatment.

There was another reason to be concerned about drug resistance rates: The study found that the risk of becoming extensively drug-resistant was more than four times higher in people who had been treated before. Having been treated before with second-line drugs was the biggest risk factor for resistance.

Researchers also discovered that biology wasn’t the only factor related to being resistant to second-line injectable drugs. Social issues such as alcohol abuse, being imprisoned, smoking, and being unemployed were also linked.

MORE: Calling All Baby Boomers: The CDC Wants You to Get Tested for Hepatitis C

“Drug-resistant TB is more difficult and costly to treat, and more often fatal,” lead author Tracy Dalton of the CDC said in a news release. “Internationally, it is particularly worrisome in areas with fewer resources and less access to effective therapies. As more individuals are diagnosed with, and treated for, drug-resistant TB, more resistance to second-line drugs is expected to emerge.”

In an accompanying editorial, Sven Hoffner of the Swedish Institute for Communicable Disease Control, said, “These results show that XDR TB is increasingly a cause for concern, especially in areas where prevalence of MDR TB is high. Nevertheless, information remains insufficient to give a clear view of the worldwide distribution and true magnitude of XDR TB. Updated information on MDR TB and investigation of the trends are urgently needed...especially since the true scale of the burden of MDR and XDR tuberculosis might be underestimated and seem to be rapidly increasing.”

In the U.S., the CDC reports that there were 11,182 TB cases in the 2010—that’s 3.6 cases per 100,000 people. Compare that to Sub-Saharan Africa, where the World Health Organization says there were more than 270 cases per 100,000 people in 2010.

“Our country’s affluence means we can address TB more vigorously than less affluent countries,” study co-author Dr. Peter Cegielski of the CDC told Time. “The way we responded to TB has a lot to do with why it is declining in the U.S. and why drug resistance isn’t such a big problem.”

Do you think these high resistance rates pose a threat to global health? Let us know in the comments.

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Jeannine Stein, a California native, wrote about health for the Los Angeles Times. In her pursuit of a healthy lifestyle she has taken countless fitness classes, hiked in Nepal, and has gotten in a boxing ring. Email Jeannine | TakePart.com

FDA approves Ironwood constipation drug

The drug, linaclotide, will be sold under the brand name Linzess and carry a boxed warning that it should not be used in patients 16 or younger, the agency said.

An estimated 63 million people suffer from chronic constipation, according to the National Institutes of Health. Additionally, an estimated 15.3 million people cope with irritable bowel syndrome (IBS), which causes abdominal pain when accompanied by constipation.

Ironwood and marketing partner Forest Laboratories said they expect the drug to be available for patients in the fourth quarter.

Gregory Wade, an analyst with Wedbush Securities, projects Linzess to be a future blockbuster with peak sales exceeding $2 billion by 2019. However, he was estimating sales of just $40 million in 2013, ramping up to $165 million in 2014.

Linzess is a capsule meant to be taken once daily on an empty stomach, at least 30 minutes before the first meal of the day, the FDA said. It relieves constipation by helping bowel movements occur more often and may ease the stomach pain associated with IBS.

Shares of Ironwood Pharmaceuticals, which were halted prior to the approval announcement and for most of the day, were down 3 percent to $12.28 on Nasdaq.

Wade suggested that investors, cautious about the launch of new drugs, may want to see how sales take off before betting on Ironwood.

"No one medication works for all patients suffering from these gastrointestinal disorders," Victoria Kusiak, a deputy director at the FDA's Center or Drug Evaluation and Research, said in a statement. "With the availability of new therapies, patients and their doctors can select the most appropriate treatment for their condition."

Shares of Forest, which is betting on a raft of new drugs to offset declining sales of its flagship antidepressant Lexapro because of generic competition, were up 1 percent at $35.01 on the New York Stock Exchange.

(Reporting by Bill Berkrot; Editing by Gerald E. McCormick and M.D. Golan)

FDA approves wider use for J&J Nucynta ER pain drug

Nucynta ER, an opioid, is already approved for extended use in moderate to severe chronic pain. But the expanded approval from the U.S. Food and Drug Administration allows Janssen to market the drug for pain tied to diabetic peripheral neuropathy, which affects up to 8 million Americans.

Some studies estimate that nearly half of all people with diabetes have some form of peripheral neuropathy, which can cause stinging or burning sensations, pain, numbness or weakness in the hands and feet, and is a major cause of amputations.

Janssen said only two other drugs were approved for pain related to the condition, but Nucynta ER is the first approved opioid.

Sales of the non-extended release version of Nucynta were $140 million in 2011 and are expected to reach $600 million in 2016, according to the average forecast of analysts polled by Thomson Reuters. The company did not immediately provide sales figures for Nucynta ER.

The FDA and other health officials have recently warned about the potential for abuse with opioids -- synthetic versions of opium that can be highly addictive, especially when taken over a long period of time.

Some researchers have said aggressive marketing by drug companies has fueled overprescribing of opioids like oxycodone and methadone.

In a statement announcing the approval, Janssen said it was committed to teaching doctors, patients and others about the responsible use of pain-killers and the prevention of misuse.

Nucynta's common side effects include nausea, constipation, vomiting, dizziness, headaches and drowsiness. Like some other opioids, the twice-daily pill in rare cases may also cause life-threatening respiratory depression.

Johnson & Johnson shares were down 0.14 percent at $67.37 in late trading on the New York Stock Exchange.

(Reporting by Anna Yukhananov)

J&J's Zytiga to be reviewed faster by FDA for additional use

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Typically, it's considered good news to lead an important race. In Missouri, it's a cause for anger and wild accusations. Rep. Todd Akin's explosive comments about rape and pregnancy have thrown a bizarre wrench in the Senate race, as partisans on both sides of the aisle claim that pollsters are artificially underestimating the other side's standing -- on purpose. Democratic-leaning pollster Public Policy Polling (PPP) went into the field Monday night -- roughly 24 hours after Akin's initial comments set off a firestorm. ...

Alarming levels of drug-resistant TB found worldwide

In a large international study published in the Lancet medical journal on Thursday, researchers found rates of both multi drug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) were higher than previously thought and were threatening global efforts to curb the spread of the disease.

"Most international recommendations for TB control have been developed for MDR-TB prevalence of up to around 5 percent. Yet now we face prevalence up to 10 times higher in some places, where almost half of the patients ... are transmitting MDR strains," Sven Hoffner of the Swedish Institute for Communicable Disease Control, said in a commentary on the study.

TB is already a worldwide pandemic that infected 8.8 million people and killed 1.4 million in 2010.

Drug-resistant TB is more difficult and costly than normal TB to treat, and is more often fatal.

MDR-TB is resistant to at least two first-line drugs — isoniazid and rifampicin - while XDR-TB is resistant to those two drugs as well as a powerful antibiotic type called a fluoroquinolone and a second-line injectable antibiotic.

Treating even normal TB is a long process, with patients needing to take a cocktail of powerful antibiotics for six months. Many patients fail to complete their treatment correctly, a factor which has fuelled a rise in the drug-resistant forms.

Researchers who studied rates of the disease in Estonia, Latvia, Peru, the Philippines, Russia, South Africa, South Korea and Thailand found almost 44 percent of cases of MDR TB were also resistant to at least one second-line drug.

Tom Evans, chief scientific officer at Aeras, a non-profit group working to develop new TB vaccines, told Reuters treatment options for XDR-TB patients were "limited, expensive and toxic".

Treatments for drug-resistant TB can cost 200 times more than those for normal TB, he said in an emailed statement. They can also cause severe side effects like deafness and psychosis, and can take two years to complete, he added.

In the United States, MDR-TB treatment can cost $250,000 or more per patient, and in many poorer countries costs can be catastrophic to health systems and patients' families.

"Without a robust pipeline of new drugs to stay one step ahead, it will be nearly impossible to treat our way out of this epidemic," Evans said.

SPREADS THROUGH AIR

Tracy Dalton from the United States Centers for Disease Control and Prevention, who led the Lancet study, said that so far, XDR-TB has been reported in 77 countries worldwide.

"As more individuals are diagnosed with, and treated for, drug-resistant TB, more resistance to second-line drugs is expected to emerge," she said.

The spread of these drug-resistant strains was "particularly worrisome" in areas with poor healthcare resources and limited access to effective drugs, she added.

TB is a bacterial infection that destroys patients' lung tissue, making them cough and sneeze and spread germs through the air. Experts say anyone with active TB can easily infect another 10 to 15 people a year.

The World Health Organization (WHO) predicts more than 2 million people will contract MDR TB by 2015.

A report by non-governmental organizations in March said a $1.7 billion shortfall in funds to fight TB over the next five years meant 3.4 million patients would go untreated and gains made against the disease will be reversed.

In their research, Dalton and colleagues found rates of resistance varied widely between countries.

Overall, resistance to any second-line drug was detected in nearly 44 percent of patients, ranging from 33 percent in Thailand to 62 percent in Latvia.

In about a fifth of cases, they found resistance to at least one second-line injectable drug. This ranged from 2 percent in the Philippines to 47 percent in Latvia.

XDR-TB was found in 6.7 percent of patients overall. Rates in South Korea, at 15.2 percent, and Russia at 11.3 percent, were more than twice the WHO's global estimate of 5.4 percent at that time.

(Editing by Andrew Heavens)

Injectable Herceptin on the Horizon for HER2 Breast Cancer Patients

IV Herceptin

Currently, Herceptin is administered in 18 sessions through an IV. I am in the process of this treatment and it required a port to be surgically placed in my chest in order for medical staff to administer the drug. Each IV session takes half an hour because I choose not to pre-treat with certain drugs to prevent side effects. I tolerate Herceptin well. If I needed to pre-treat the infusion time would be about an hour.

It is possible to deliver Herceptin through an IV in the arm, but my physician decided a port is the better route for my particular situation.

In order for me to receive Herceptin treatments, I have to travel two hours each way to the cancer-treatment facility, once every three weeks. It is a hassle and an increased expense for me.

Injectable Herceptin

A study published in the September 2012 edition of The Lancet Oncology shows that Herceptin administered subcutaneously, or by injection, is just as effective as the IV form of the drug. This is a huge advancement for patients requiring treatment with Herceptin. Once chemotherapy is completed, Herceptin is given as a single drug.

An injectable form of Herceptin opens the door for breast cancer patients to self-administer the drug. This will save patients time, money and stress. It will eliminate the need to travel to a doctor's office or cancer-treatment facility for IV infusions. By removing the need for medical staff to administer the drug, overall medical costs are reduced; the potential savings for patients is huge. This advancement opens the door for low-income patients without adequate insurance to have access to Herceptin treatment.

From a business perspective, providing an injectable form of the drug extends the patent for Genentech and Roche Biomedical. This is one scenario where both the patient and drug company benefit. If I was offered the choice of self-administering Herceptin or continuing with the current IV treatments, I would opt for the injectable version. The savings in travel expenses alone would make it very worthwhile.

Lynda Altman was diagnosed with breast cancer in November 2011. She writes a series for Yahoo! Shine called "My Battle With Breast Cancer."

One Small Thing: Get Moving to Reduce Migraines

Why you need to do it: While medications can greatly reduce the incidence of migraines, they don’t always work. Some drugs have side effects, and not everyone wants to take them. Exercise can be a low-cost, non-invasive effective treatment.

A 2011 study in the journal Cephalagia found that among a group of migraine sufferers, moderate weekly exercise worked as well as the migraine drug topiramate and relaxation exercises in reducing migraine rates.

MORE: One Small Thing: Cut Back on Mutlitasking and Improve Your Memory

Other studies, Peterlin says, have linked obesity with a higher risk of migraines, as well as weight loss in obese people with a reduction in migraines. Some research suggests an association between a sedentary lifestyle and an increase in headaches.

The connection? Obesity contributes to inflammation, which may play a role in migraines as well. Exercise has been shown in some studies to be effective in tamping down inflammation in the body.

What you can do: Moderate amounts of aerobic activity can make a difference, Peterlin says, so don’t worry about having to train for an Ironman triathlon. Doing something—taking a brisk walk several times a week—is better than nothing, but she suggests striving for the government recommendation of being active for 150 minutes a week (basically a half-hour a day, five days a week).

“Eat a healthy diet, get moving and avoid excessive weight gain,” she says. “There are things you can do without your doctor, or sometimes in addition to what your doctor recommends.”

Do you suffer from migraines or bad headaches? What are your remedies? Let us know in the comments.

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Will starving yourself help you live longer? Maybe not

New research published on Wednesday, however, shows the extreme, emaciating diet doesn't increase lifespan in rhesus monkeys, the closest human relatives to try it in a rigorous, long-running study. While caveats remain, outside experts regarded the findings as definitive, particularly when combined with those from a similar study.

"If there's a way to manipulate the human diet to let us live longer, we haven't figured it out yet and it may not exist," said biologist Steven Austad of the University of Texas Health Science Center's Barshop Institute for Longevity and Aging Studies, who wrote an analysis of the study in Nature.

Since 1934, research has shown that lab rats, mice, yeast, fruit flies and round worms fed 10 percent to 40 percent fewer calories than their free-eating peers lived some 30 percent longer. In some studies, they lived twice as long.

Such findings have spawned a growing community of believers who seek better health and longer life in calorie-restricted (CR)diets, as promised in the 2005 book "The Longevity Diet," including 5,000 members of the CR Society International. The research has also prompted companies like Procter & Gamble and Nu Skin Enterprises to develop drugs to mimic the effects of calorie restriction.

The new study, from the National Institute on Aging, part of the U.S. National Institutes of Health, suggests a surprising disconnect between health and lifespan. It found that most of the 57 calorie-restricted monkeys had healthier hearts and immune systems and lower rates of diabetes, cancer or other ills than the 64 control monkeys. But there was no longevity pay-off.

"You can argue that the calorie-restricted animals are healthier," said Austad. "They have better cholesterol profiles, less muscle loss, less disease. But it didn't translate into greater longevity. What we learn from this is you can un-link health and longevity."

YOUNGER IMMUNE SYSTEMS, LESS HEART DISEASE

The NIA study, launched in 1987, is one of two investigating whether eating just 70 percent of the calories in a standard lab diet extends life in a long-lived primate. The Wisconsin National Primate Research Center's study, begun in 1989, also uses rhesus monkeys, whose physiology, genetics and median lifespan (27 years) are closer to humans than are the rodents in earlier calorie-restriction research.

Initial results were promising. In 2006 the NIA group reported that calorie-restricted monkeys had younger-seeming immune systems. Wisconsin reported that after 20 years of eating like birds, the monkeys were less likely to get heart disease, diabetes, cancer and other diseases of aging.

They also lived longer: By 2009, 80 percent of the free-eating Wisconsin monkeys had died of age-related illness, but only 50 percent of calorie-restricted monkeys had. Those findings, the scientists reported at the time, showed "that CR slows aging in a primate species."

Experts on aging have since waited for the NIA to weigh in, and the verdict was a shock: "The calorie-restricted monkeys lived no longer than the other monkeys," NIA's Julie Mattison, who helped lead the study, told Reuters.

The oldest animals in each group had the same incidence of tumors, heart disease and general deterioration. While the abstemious monkeys had some improved health markers such as cholesterol and triglyceride levels, Mattison said, "that didn't translate into better survival."

The NIA study showed that even monkeys starting calorie restriction early in life, from 1 to 14 years of age, had no lifespan edge over their gourmand peers. With 19 of the 40 monkeys whose eating was restricted starting in youth still alive, the NIA scientists calculated, the chance that they will outlive free-eating monkeys is less than one-tenth of 1 percent.

Perhaps more surprising, health markers were often worse in monkeys that began calorie restriction as young adults than older ones, the opposite of what scientists expected. And more of the animals that started calorie restriction when young died of causes unrelated to aging than did their free-eating peers. "There may be something about calorie restriction that makes animals more susceptible to death from other causes," said Austad.

A KILLER CONTROL GROUP

Scientists offered several explanations for why the NIA's findings differ from more encouraging results in the Wisconsin study.

The Wisconsin monkeys' diet had seven times the table sugar (28 percent of calories, like Americans' diets) as the NIA's (4 percent). The Wisconsin control monkeys also ate however much they wished; the NIA control monkeys ate a fixed amount and, as a result, weighed less.

That suggests the longevity diet didn't really extend lifespan in the Wisconsin monkeys: It only seemed to because the control monkeys ate themselves into an early grave.

"Comparing calorie restriction to what you think is a normal diet but is in fact an unhealthy diet with too much food and too much sucrose can trip you up," said Austad. "If you keep your control animals to a healthy weight, as the NIA did, a diet that produces extreme emaciation has no further effect on longevity."

Most problematic, many of the Wisconsin study's calorie-restricted monkeys died of causes unrelated to aging, such as anesthesia used in some experiments and gastrointestinal bloat.

Only by not counting those deaths did the Wisconsin scientists find a statistically significant longevity effect, said Wisconsin's Ricki Colman, a leader of that study.

It is too soon to know how the NIA study will affect the development of drugs aimed at replicating calorie restriction's benefits without the hunger pangs. They include mannoheptulose, a compound derived from unripe avocados that "tricks cells into thinking they ate less," said George Roth, CEO of privately held GeroScience.

Roth helped launch the NIA study and is a co-author of the new paper. He believes there is still good evidence in favor of calorie restriction, including the Wisconsin study's findings. GeroScience is working with Procter & Gamble to use mannoheptulose as a lifespan-increasing supplement for dogs and hopes to raise money for a clinical trial in people.

LifeGen Technologies, co-founded by a leader of the Wisconsin study, is testing a nutraceutical that mimicked some genetic changes seen with calorie restriction in rodents. The company was bought by Nu Skin Enterprises in 2011.

The NIA and Wisconsin teams are continuing to collect data to see if calorie restriction suddenly proves more beneficial. "But what I take away from these studies is that extreme emaciation may not be the correct paradigm," said University of Texas biologist Austad. "If I were them (companies or scientists banking on this), I'd be worried."

(Editing by Michele Gershberg and Ciro Scotti)

FDA approves Teva version of Amgen's Neupogen

Teva's medicine is in many ways a copy of Amgen Inc's biologic drug Neupogen, which faces the expiration of its U.S. patent next year.

In an a settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta, Amgen's longer-lasting white blood cell booster, in the United States until November 2013.

"While approval at this time is somewhat unexpected, we note the two drugs are not substitutable, and it will require a launch ramp and extensive marketing efforts by Teva to gain share," RBC Capital Markets analyst Michael Yee said in a research note.

Amgen's U.S. sales of Neupogen were $959 million last year, while sales of Neulasta were $3 billion.

Teva already sells its version of Neupogen, or filgrastim, in the European Union, where Yee said it accounts for about 5 percent of the overall market.

The agency said Teva's drug, called tbo-filgrastim, stimulates bone marrow to increase production of white blood cells, which may help cancer patients recover more quickly from the side effects of chemotherapy.

The Israel-based generic drug maker gained its approval under a standard U.S. Food and Drug Administration review.

Although the FDA has issued draft guidelines for review and approval of lower-cost copies of biotech drugs - often referred to as "biosimilars" because they are not made from the same living cell line as the original drug, the rules remain uncertain.

Biotech drugs, which are derived from living matter such as proteins, are usually given by injection. The innovative drugs - first introduced in the 1980s - can cost tens of thousands of dollars a year. Copying them is much more complicated, and expensive, than duplicating conventional chemical-based compounds.

The approval process for generic versions of chemical-based pills has existed for nearly 30 years. The FDA's draft guidelines are meant to provide a similar "abbreviated pathway" for biotech medicines. But the complexity of biosimilars has led to a drawn-out process and more questions posed by the industry.

As global pharmaceutical companies face the loss of patent protection on many established drugs, U.S. sales of biosimilars are expected to reach $1.9 billion to $2.6 billion by 2015, according to IMS Health.

(Reporting by Anna Yukhananov, Deena Beasley and Bangalore equities newsroom; Editing by Dan Grebler, Steve Orlofsky and Edwina Gibbs)

Novartis to seek lung treatment launch in Europe, Japan

The drug, QVA149, combines Novartis's Onbrez and its other lung drug NVA237 as a two-in-one medicine that should allow Novartis to take on market leader GlaxoSmithKline. An application for approval in the United States is set to be filed at the end of next year, Novartis said.

However, Bank Vontobel analyst Andrew Weiss said that although Novartis showed the drug to be superior to another of its own drugs, QVA149 is not significantly better than Spiriva, a rival drug from Pfizer and Boehringer Ingelheim in treating patients with chronic obstructive pulmonary disease.

COPD causes breathing trouble and chronic coughing, and is sometimes fatal. It affects an estimated 210 million people worldwide and is predicted to be the third leading cause of death by 2020, Novartis said.

"Without superiority to Spiriva, we doubt this data will give QVA an edge," said Weiss, who rates Novartis shares as a 'reduce' with a 50-franc target price.

Novartis and its British partner Vectura faced delays in October last year in the United States for NVA237, which in turn affected the approval timing for QVA149.

Shares in Novartis were trading unchanged at 56.55 francs by 0846 GMT on Thursday, when Vectura's shares were down 0.6 percent at 82 pence.

Novartis needs drugs such as QVA149, which some analysts predict could be a major revenue earner by 2020, to fill the gap left by loss of exclusivity on its current top-selling drugs such as blood pressure medicine Diovan.

(Editing by Greg Mahlich)

Drug resistant tuberculosis found across the world

TB is already a worldwide pandemic that in 2010 infected 8.8 million people and killed 1.4 million of them.

Drug-resistant TB is more difficult and costly than normal TB to treat, and is more often fatal.

Treating even normal TB is a long process, with patients needing to take a cocktail of powerful antibiotics for six months. Many patients fail to correctly complete treatment, a factor which has fuelled a rise in the drug-resistant forms.

Researchers who studied rates of the disease in Estonia, Latvia, Peru, the Philippines, Russia, South Africa, South Korea, and Thailand found that almost 44 percent of cases of MDR TB were also resistant to at least one second-line drug.

SPREADS THROUGH AIR

Tracy Dalton from the United States Centers for Disease Control and Prevention, who led the study, said that so far, XDR-TB has been reported in 77 countries worldwide.

"As more individuals are diagnosed with, and treated for, drug-resistant TB, more resistance to second-line drugs is expected to emerge," she said.

The spread of these drug-resistant strains was "particularly worrisome" in areas with poor healthcare resources and limited access to effective drugs, she added.

The World Health Organisation (WHO) predicts that more than 2 million people will contract MDR TB by 2015.

A report by non-governmental organizations in March warned that $1.7 billion shortfall in global funds to fight TB over the next five years meant 3.4 million patients would go untreated and gains made against the disease will be reversed.

In their research, Dalton and colleagues found that rates of resistance varied widely between countries.

Overall, resistance to any second-line drug was detected in nearly 44 percent of patients, ranging from 33 percent in Thailand to 62 percent in Latvia.

In around a fifth of cases, they found resistance to at least one second-line injectable drug. This ranged from 2 percent in the Philippines to 47 percent in Latvia.

XDR-TB was found in 6.7 percent of patients overall. Rates in South Korea, at 15.2 percent, and Russia at 11.3 percent, were more than twice the WHO's global estimate of 5.4 percent at that time.

"These results show that XDR-TB is increasingly a cause for concern, especially in areas where prevalence of MDR-TB is high," said Hoffner.

(Editing by Alison Williams)

Midwives, nurses can safely perform abortions

Researchers analyzed five studies that compared first-trimester abortion complications and side effects based on who performed the procedures in close to 9,000 women - and typically found no differences.

"As access to abortion is increasingly restricted, the including of non-physicians in the pool of providers is really vital because fewer and fewer people will have access as there are more and more barriers," said Amy Levi, a professor of midwifery at the University of New Mexico in Albuquerque.

Having trained nurses and midwives perform abortions could also allow some women to get care before they would be able to see a doctor - and earlier access typically means fewer complications and better outcomes, Levi said.

That's especially the case in developing countries, where doctors who perform abortions may be few and far between.

In studies conducted in clinics and hospitals in Asia, Africa and the United States, procedures supervised by nurses or midwives and doctors had similar rates of incomplete abortion, incorrect determination of the fetus' age and complications such as bleeding and injuries to the uterus.

For example, in one study of about 1,400 women getting an abortion in Vermont or New Hampshire, there were complications in 2.2 percent of procedures with a physician assistant and 2.3 percent with a doctor.

Nathalie Kapp from the World Health Organization in Geneva, Switzerland and her colleagues said the findings don't apply to nurses and midwives who perform abortions without access to emergency care nearby, or to abortions done after the first trimester.

They published their findings in BJOG: An International Journal of Obstetrics and Gynaecology.

According to the Guttmacher Institute, a sexual and reproductive health organization, 39 states require abortions to be performed by a licensed physician. And Levi, who was not involved in the new study, said only a few allow non-physicians to perform abortions both surgically and medically (with drugs).

But the findings are "really powerful" in other parts of the world, where unsafe abortion is one of the leading causes of maternal death and non-physician providers far outnumber doctors, said Levi, who wasn't involved in the new study.

They are also consistent with her expectations after working for a California-based program that trains nurse practitioners, midwives and physician assistants to perform abortions safely, she told Reuters Health.

"Access to safe abortion is imperative for reducing maternal mortality worldwide," Levi said.

"We need to keep the conversation embedded in women's health care, which is where it belongs, and I think this kind of data will help."

SOURCE: http://bit.ly/OuBwsh BJOG: An International Journal of Obstetrics and Gynaecology, online August 20, 2012.