16.03.2012 17:42:00
International phase 3 trial is largest study ever of rare endocrine disorder
A new investigational drug significantly reduced urinary cortisol levels and improved symptoms of Cushing's disease in the largest clinical study of this endocrine disorder ever conducted. Results of the clinical trial conducted at centers on four continents appear in the March 8
New England Journal of Medicine
and show that treatment with pasireotide cut cortisol secretion an average of 50 percent and returned some patient’s levels to normal.
Beverly M.K. Biller, MD, of the Massachusetts General Hospital
Neuroendocrine Unit, senior author of the study. "Often misdiagnosed, Cushing's is associated with a broad range of health problems – causing physical changes, metabolic abnormalities and emotional difficulties – and if not controlled, significantly increases patients' risk of dying much younger than expected."
One of several conditions that lead to Cushing's syndrome – chronically elevated secretion of the hormone cortisol – Cushing's disease is caused by a benign pituitary tumor that oversecretes the hormone ACTH, inducing increased cortisol secretion by the adrenal glands. Symptoms of Cushing's syndrome include weight gain, hypertension, mood swings, irregular or absent periods, abnormalities of glucose processing – insulin resistance, glucose intolerance and type 2 diabetes – and cardiovascular disease. Since those symptoms are associated with many health problems, physicians may not consider the rare possibility of Cushing's. The diagnosis can be difficult to make and usually requires the expertise of an endocrinologist. Since cortisol levels normally fluctuate during the day, a single blood test probably would not identify chronic elevation, so the most common diagnostic test measures a patient's 24-hour urinary output.
First-line treatment for Cushing's disease is surgical removal of the ACTH-secreting tumor, which can lead to remission in 65 to 90 percent of patients who are treated by expert pituitary surgeons. But symptoms return in 10 to 30 percent of those patients, requiring repeat surgery, radiation therapy or treatment with drugs that interfere with part of the cortisol control system. Until last month, there was no specific FDA-approved medical treatment for Cushing's syndrome; and while the newly approved drug mifepristone should benefit some patients, it does not affect the pituitary source of the condition or reduce cortisol levels.
The current phase 3 trial of pasireotide – the first drug that blocks ACTH secretion by binding to somatostatin receptors on the pituitary tumor – was sponsored by Novartis Pharma and enrolled 162 patients at 62 sites in 18 countries. Almost 85 percent of participants had either persistent disease that had not responded to surgery or had recurrent disease. The other 15 percent were recently diagnosed but not appropriate candidates for surgery. Participants were randomly assigned to two groups, one starting at two daily 600-microgram injections of pasireotide, the other receiving 900-microgram doses. Three months into the 12-month trial, participants whose urinary cortisol levels remained more than twice the normal range had their dosage levels increased. During the rest of the trial, dosage could be further increased, if necessary, or reduced if side effects occurred.
At the end of the study period, many patients had a significant decrease in their urinary cortisol levels, with 33 achieving levels within normal range at their original dosage by month 6 of the trial. Participants whose baseline levels were less than five times the upper limit of normal were more likely to achieve normal levels than those with higher baseline levels, and the average urinary cortisol decrease across all participants was about 50 percent. Many Cushing's disease symptoms decreased, and it became apparent within the first two months whether or not an individual was going to respond to pasireotide.
Transient gastrointestinal discomfort, known to be associated with medications in the same family as pasireotide, was an expected side effect. But the investigators observed elevated glucose levels in 73 percent of participants, something not seen to the same extent with other medications in this family. That will require close attention, since many Cushing's patients already have trouble metabolizing glucose. Biller explains, "Those patients who already were diabetic had the greatest increases in blood sugar, and those who were pre-diabetic were more likely to become diabetic than those who began with normal blood sugar. However, elevations were even see in those who started at normal glucose levels, so this is real and needs to be monitored carefully."
Additional trials of pasireotide are in the works, and a phase 3 study of a long-acting version of the drug was recently announced. Biller notes that the potential addition of pasireotide to available medical treatments for Cushing's disease would have a number of advantages. "It's very important to have medications that work at different parts of the cortisol control system – which is the case for the currently used medications that work at the adrenal gland level, pasireotide which works at the pituitary gland, and mifepristone which blocks the action of cortisol at receptors in the body. Having more options that work in different ways is valuable because not all patients respond to one medicine and some may be unable to tolerate a specific drug's side effects.
"As we have more drugs available to treat Cushing’s," she adds. "I think in the long run we may start using combinations of drugs, which is the approach we use in some patients with acromegaly, another disorder in which a pituitary tumor causes excess hormone secretion. Ultimately we hope to be able to give lower doses leading to fewer overall side effects, but that remains to be determined by future studies." Biller is a professor of Medicine at Harvard Medical School.
Annamaria Colao, MD, PhD, University of Naples, Italy, is the lead author of the
New England Journal
report. Additional co-authors are Stephan Petersenn, MD, University of Duisberg-Essen, Germany; John Newell-Price, MD, PhD, University of Sheffield, U.K.; James Findling, MD, Medical College of Wisconsin, Milwaukee; Feng Gu, MD, Peking Union Medical College Hospital, Beijing, China; Mario Maldonado, MD, Ulrike Schoenherr, Dipl-Biol, and David Mills, MSc, Novartis Pharma; and Luiz Roberto Salgado, MD, University of São Paulo Medical School, Brazil.
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $750 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine.
From
http://www.massgeneral.org/about/pressrelease.aspx?id=1444#.T2I2Ue9AMtQ.facebook
16.03.2012 14:12:15
Few Americans think twice about whether their medicine bottle really contains what it says on the label.
15.03.2012 23:53:19
Few Americans think twice about whether their medicine bottle really contains what it says on the label.
16.03.2012 22:15:59
Sanuwave plans to run additional clinical trials of its dermaPace foot ulcer treatment after the FDA deems its initial submission insufficient.
Regenerative medicine firm
Sanuwave Health (OTC:
SNWV will run another clinical trial of its dermaPace foot ulcer treatment, after the FDA determined that its initial pre-market approval bid failed to meet its primary endpoint.
New trials may take up to 2 years before the company re-submits its device for FDA review, according to a press release.
News Well,
Diabetes,
Food & Drug Administration (FDA ,
Pre-Market Approval (PMA ,
Regenerative Medicine
Diabetes,
Food & Drug Administration (FDA ,
Pre-Market Approval (PMA ,
Regenerative Medicine
http://www.massdevice.com/news/sanuwave-takes-its-dermapace-foot-ulcer-treatment-back-trials#comments
16.03.2012 7:00:42
Del Monte Fresh Produce has withdrawn its threatened lawsuit against the Oregon Public Health Division and its senior epidemiologist, who with other public health officials last year traced a multistate outbreak of Salmonella infection to cantaloupes imported from the company's Asuncion Mita farm in Guatemala.
The news was reported by Lynne Terry of The Oregonian. She wrote that Del Monte Fresh Produce notified the state earlier this month that it would not go forward with legal action against William Keene and his department.
Del Monte Fresh Produce had announced its threat in a news release in August, claiming that "misleading allegations" had been made in naming the Guatemalan cantaloupes as the likely source of Salmonella infection that sickened at least 20 people, and sent three to the hospital. The case patients were from Arizona, California, Colorado, Maryland, Montana, Nebraska, Oregon, Pennsylvania, Utah and Washington.
Twelve of 16 ill people had reported eating cantaloupe in the week before they became ill, according to a Centers for Disease Control and Prevention report on the outbreak investigation. Eleven of those 12 people had purchased cantaloupes from eight different Costco stores and traceback information indicated the melons were from a single farm -- Asuncion Mita in Guatemala.
Del Monte Fresh Produce voluntarily recalled the Guatemalan cantaloupes on March 22, 2011 after it was notified of the epidemiological link between the melons the outbreak of Salmonella Panama infection.
But when the Food and Drug Administration banned further cantaloupe imports from the company's Guatemalan farm, Del Monte Fresh Produce sued the FDA and got it to back down on the import alert. It also claimed it was wrongly blamed for the outbreak.
Food safety experts and consumer activists predicted the case targeting Oregon Public Health -- recognized for its food safety leadership -- would not go far, but said they saw the complaint filed by Del Monte Fresh Produce as an attempt to intimidate public health programs across the country.
Dr. Katrina Hedberg, Oregon state epidemiologist, told The Oregonian that dealing with the tort claim had been time-consuming, so it was a relief when it was withdrawn and they could resume focusing on their job -- protecting the public's health.
The claim was unprecedented, Terry noted:
State epidemiologists investigate dozens of foodborne illness outbreaks every year and name the culprits to prevent more people from getting sick. No other company has ever filed a suit or threatened to sue Oregon over one of those investigations.
"There have been lots of outbreaks," Hedberg said. "Why some companies choose to work with public health and others want to fight it -- I can't answer that."
A Del Monte Fresh Produce spokesman declined to comment, telling Terry the company "does not comment on ongoing or closed investigations."
The news was reported by Lynne Terry of The Oregonian. She wrote that Del Monte Fresh Produce notified the state earlier this month that it would not go forward with legal action against William Keene and his department.
Del Monte Fresh Produce had announced its threat in a news release in August, claiming that "misleading allegations" had been made in naming the Guatemalan cantaloupes as the likely source of Salmonella infection that sickened at least 20 people, and sent three to the hospital. The case patients were from Arizona, California, Colorado, Maryland, Montana, Nebraska, Oregon, Pennsylvania, Utah and Washington.
Twelve of 16 ill people had reported eating cantaloupe in the week before they became ill, according to a Centers for Disease Control and Prevention report on the outbreak investigation. Eleven of those 12 people had purchased cantaloupes from eight different Costco stores and traceback information indicated the melons were from a single farm -- Asuncion Mita in Guatemala.
Del Monte Fresh Produce voluntarily recalled the Guatemalan cantaloupes on March 22, 2011 after it was notified of the epidemiological link between the melons the outbreak of Salmonella Panama infection.
But when the Food and Drug Administration banned further cantaloupe imports from the company's Guatemalan farm, Del Monte Fresh Produce sued the FDA and got it to back down on the import alert. It also claimed it was wrongly blamed for the outbreak.
Food safety experts and consumer activists predicted the case targeting Oregon Public Health -- recognized for its food safety leadership -- would not go far, but said they saw the complaint filed by Del Monte Fresh Produce as an attempt to intimidate public health programs across the country.
Dr. Katrina Hedberg, Oregon state epidemiologist, told The Oregonian that dealing with the tort claim had been time-consuming, so it was a relief when it was withdrawn and they could resume focusing on their job -- protecting the public's health.
The claim was unprecedented, Terry noted:
State epidemiologists investigate dozens of foodborne illness outbreaks every year and name the culprits to prevent more people from getting sick. No other company has ever filed a suit or threatened to sue Oregon over one of those investigations.
"There have been lots of outbreaks," Hedberg said. "Why some companies choose to work with public health and others want to fight it -- I can't answer that."
A Del Monte Fresh Produce spokesman declined to comment, telling Terry the company "does not comment on ongoing or closed investigations."
16.03.2012 13:49:03
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2012-03-16 04:45:59
American schools will soon be able to stop receiving the ammonia-treated ground beef product known alternately as boneless lean beef trimmings, lean finely textured beef, and--more derisively--"pink slime," the U.S. Agriculture Department (
USDA announced on Thursday. According to Michael Hill of the
Associated Press (AP , starting next fall districts will be able to choose to continue receiving 95% lean beef patties that include the filler product, or fattier cuts of ground beef that is free of the ammonia-treated substance. The change in policy cannot go into effect immediately due to existing contracts, an unidentified USDA official told the news organization. "Though the term 'pink slime' has been used pejoratively for at least several years, it wasn't until last week that social media suddenly exploded with worry and an online petition seeking its ouster from schools," Hill wrote. "The petition quickly garnered hundreds of thousands of supporters" "The low-cost ingredient is made from fatty bits of meat left over from other cuts. The bits are heated to about 100 F and spun to remove most of the fat. The lean mix then is compressed into blocks for use in ground meat. The product, made by South Dakota-based
Beef Products Inc., also is exposed to 'a puff of ammonium hydroxide gas' to kill bacteria, such as E. coli and salmonella," he added. The USDA told Hill that the agency, which is responsible for purchasing about 20% of the food used in school lunches across the country, "continues to affirm the safety" of the boneless lean beef trimmings. However, they said that they wanted to be "transparent" and recognized that schools wanted to be able to opt out of receiving the ammonia-treated lean finely textured beef. The controversy involves not just the beef itself, but also the use of ammonium hydroxide to treat the meat. The product itself,
AFP reporter Robert MacPherson says, is "left-over bits of slaughtered cattle… that is mixed in a centrifuge" -- or as chef Jamie Oliver puts it, according to an article by Amy Hubbard of the
Los Angeles Times, "all of the bits that no one wants." Once the beef products are mixed together, they are treated with ammonium hydroxide in a USDA-approved process in order to prevent E. coli and salmonella contamination, Hubbard said.
International Food Information Council Director of Media Relations Steven Cohen told her that the substance had been reviewed and deemed safe by the Food & Drug Administration (
FDA in 1974, and that it is an additive used in other products, including cheese and chocolates. However, the Times reporter adds that it is also used as a "sanitizer in many household and industrial cleaners," which has led
McDonalds and other restaurant chains to discontinue the use of the so-called "pink slime" beef products. Despite the USDA's announcement Thursday, Hill says that Maine Representative
Chellie Pingree has asked
Agriculture Secretary Tom Vilsack to immediately and permanently ban its use in schools. "The beef industry sent my office an email the other day describing pink slime as 'wholesome and nutritious' and said the process for manufacturing it is 'similar to separating milk from cream.' I don't think a highly processed slurry of meat scraps mixed with ammonia is what most families would think of as 'wholesome and nutritious,'" the Congresswoman said in a statement.
USDA announced on Thursday. According to Michael Hill of the
Associated Press (AP , starting next fall districts will be able to choose to continue receiving 95% lean beef patties that include the filler product, or fattier cuts of ground beef that is free of the ammonia-treated substance. The change in policy cannot go into effect immediately due to existing contracts, an unidentified USDA official told the news organization. "Though the term 'pink slime' has been used pejoratively for at least several years, it wasn't until last week that social media suddenly exploded with worry and an online petition seeking its ouster from schools," Hill wrote. "The petition quickly garnered hundreds of thousands of supporters" "The low-cost ingredient is made from fatty bits of meat left over from other cuts. The bits are heated to about 100 F and spun to remove most of the fat. The lean mix then is compressed into blocks for use in ground meat. The product, made by South Dakota-based
Beef Products Inc., also is exposed to 'a puff of ammonium hydroxide gas' to kill bacteria, such as E. coli and salmonella," he added. The USDA told Hill that the agency, which is responsible for purchasing about 20% of the food used in school lunches across the country, "continues to affirm the safety" of the boneless lean beef trimmings. However, they said that they wanted to be "transparent" and recognized that schools wanted to be able to opt out of receiving the ammonia-treated lean finely textured beef. The controversy involves not just the beef itself, but also the use of ammonium hydroxide to treat the meat. The product itself,
AFP reporter Robert MacPherson says, is "left-over bits of slaughtered cattle… that is mixed in a centrifuge" -- or as chef Jamie Oliver puts it, according to an article by Amy Hubbard of the
Los Angeles Times, "all of the bits that no one wants." Once the beef products are mixed together, they are treated with ammonium hydroxide in a USDA-approved process in order to prevent E. coli and salmonella contamination, Hubbard said.
International Food Information Council Director of Media Relations Steven Cohen told her that the substance had been reviewed and deemed safe by the Food & Drug Administration (
FDA in 1974, and that it is an additive used in other products, including cheese and chocolates. However, the Times reporter adds that it is also used as a "sanitizer in many household and industrial cleaners," which has led
McDonalds and other restaurant chains to discontinue the use of the so-called "pink slime" beef products. Despite the USDA's announcement Thursday, Hill says that Maine Representative
Chellie Pingree has asked
Agriculture Secretary Tom Vilsack to immediately and permanently ban its use in schools. "The beef industry sent my office an email the other day describing pink slime as 'wholesome and nutritious' and said the process for manufacturing it is 'similar to separating milk from cream.' I don't think a highly processed slurry of meat scraps mixed with ammonia is what most families would think of as 'wholesome and nutritious,'" the Congresswoman said in a statement.
16.03.2012 20:51:27
An FDA panel on Tuesday will review new cancer drugs by Merck and Glaxo.
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