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Two Drugs Show Promise Against Severe Constipation

WEDNESDAY, May 28 (HealthDay News) -- Two new medications offer hope for the most severe forms of constipation.

Almost 15 percent of Americans are constipated at any given time, said Dr. Michael Camilleri, lead author of one of two reports in the May 29 issue of the New England Journal of Medicine. His paper reported on the efficacy of the experimental drug prucalopride on 620 people with chronic constipation.

"A minority of people have constipation because the nerves are not working well," Camilleri said. "These people, on average, had one bowel movement every two weeks."

It's not known how many Americans have such severe constipation, but "patients with this condition are seen regularly," said Camilleri, a gastroenterologist who is professor of medicine and physiology at the Mayo Clinic, in Rochester, Minn.

In the study, 47.3 percent of the people who took 2 milligrams a day of prucalopride for 12 weeks had three or more bowel movements a week, compared to 25.8 percent of those given a placebo. The success rate for people given 4 milligrams a day of prucalopride was slightly lower, at 46.6 percent.

"The results were better than with similar medications available in the past," Camilleri said.

An accompanying editorial by Dr. Arthur J. Moss, a professor of medicine and physiology at the University of Rochester in New York, raised two questions about the drug and the trial.

Two drugs that act in the same way as prucalopride were taken off the market, because they caused heart problems, Moss said. There was no indication of such problems in the newly reported trial, but that was true of the other medications at the same point in their development, he said.

"The pre-marketing studies were benign," Moss said. "But you just don't know until you get mass marketing."

The only similarity between prucalopride and the older drugs was that they acted on a cell receptor that stimulates cells in the wall of the intestines to induce muscle contraction, Camilleri said. "There is no chemical resemblance," he said. "Those other two medications also affect a certain kind of channel in the heart conduction system which makes it likely they will be associated with abnormalities in the heart."

And results of the prucalopride trial are just being published, even though the trial ended in 1999, Moss noted. "Its rather unusual for a study completed in 1999 to wait an additional nine years for publication, so I raised that point," he said.

Publication was delayed, because "in animal studies, toxicology showed an imbalance in the number of tumors," Camilleri said. The imbalance was seen in longer-term high doses" he said, so additional safety studies were needed before publication.

Another report in the same issue of the journal described a successful trial of a new drug to relieve the constipation experienced by very ill people given narcotic drugs to ease their pain.

In the trial that included 133 people who have received such opioid painkillers for two or more weeks, 48 percent of those getting the drug, methylnaltrexone, had bowel movements within four hours of the first dose, compared to 15 percent of those getting a placebo. More than half of those given the drug had a bowel movement without the use of an additional laxative, compared to 8 percent of those in the placebo group.

The trial was one of two studies that led to approval of the drug, which is given by injection, by the U.S. Food and Drug Administration last month.
http://news.yahoo.com

Disclosing drug makers payments to docs gets boost

By KEVIN FREKING, Associated Press Writer Tue May 13, 5:02 PM ET

WASHINGTON - Legislation that would require prescription drug makers to disclose payments to doctors got a boost Tuesday when Eli Lilly and Co. broke ranks with the industry and endorsed the bill.

Lawmakers gained Eli Lilly's support after they agreed to raise the payment limit requiring disclosure from $25 to $500. The lawmakers also agreed to apply the legislation to all drug and medical device makers. Previously, the proposed disclosures would have applied only to companies with more than $100 million in annual revenue.

The legislation addresses concerns that payments, such as picking up the tab for dinner or paying travel expenses for a conference at an exotic locale, can influence a doctor's prescribing habits. The legislation doesn't ban the payments, but it does require that companies report them, beginning March 31, 2011.

The legislation would pre-empt laws in the few states that already require drug makers to disclose their payments to doctors.

John C. Lechleiter, Eli Lilly's president and CEO, said the pre-emption was an important addition to the bill.

"This helps patients, businesses and doctors alike by setting expectations and creating a more efficient system for gathering, reporting and understanding such data," Lechleiter said.

Last year, the company was the first drug maker to publicly report all of its educational grants and charitable contributions.

The bill's sponsor, Sen. Charles Grassley, R-Iowa, and top Democratic co-sponsor, Sen. Herb Kohl of Wisconsin, said Eli Lilly's endorsement shows "transparency's time has come."

"Transparency brings about accountability and benefits everyone, consumers most of all," Grassley said.

The lawmakers are pressing to get provisions of The Physician Payments Sunshine Act into a bill later this year that would prevent payment cuts to doctors caring for Medicare patients.

Disclosing drug makers payments to docs gets boost

By KEVIN FREKING, Associated Press Writer Tue May 13, 5:02 PM ET

WASHINGTON - Legislation that would require prescription drug makers to disclose payments to doctors got a boost Tuesday when Eli Lilly and Co. broke ranks with the industry and endorsed the bill.

Lawmakers gained Eli Lilly's support after they agreed to raise the payment limit requiring disclosure from $25 to $500. The lawmakers also agreed to apply the legislation to all drug and medical device makers. Previously, the proposed disclosures would have applied only to companies with more than $100 million in annual revenue.

The legislation addresses concerns that payments, such as picking up the tab for dinner or paying travel expenses for a conference at an exotic locale, can influence a doctor's prescribing habits. The legislation doesn't ban the payments, but it does require that companies report them, beginning March 31, 2011.

The legislation would pre-empt laws in the few states that already require drug makers to disclose their payments to doctors.

John C. Lechleiter, Eli Lilly's president and CEO, said the pre-emption was an important addition to the bill.

"This helps patients, businesses and doctors alike by setting expectations and creating a more efficient system for gathering, reporting and understanding such data," Lechleiter said.

Last year, the company was the first drug maker to publicly report all of its educational grants and charitable contributions.

The bill's sponsor, Sen. Charles Grassley, R-Iowa, and top Democratic co-sponsor, Sen. Herb Kohl of Wisconsin, said Eli Lilly's endorsement shows "transparency's time has come."

"Transparency brings about accountability and benefits everyone, consumers most of all," Grassley said.

The lawmakers are pressing to get provisions of The Physician Payments Sunshine Act into a bill later this year that would prevent payment cuts to doctors caring for Medicare patients.
source:http://news.yahoo.com/

Drug adherence does not explain diabetes race gap

Wed May 14, 3:00 PM ET

NEW YORK (Reuters Health) - Differences in medication adherence do not fully explain why African Americans fare more poorly than whites in managing their diabetes, a new study suggests.

Research has shown that black adults with type 2 diabetes tend to have more problems with blood sugar control, as well as a higher risk of diabetes complications, than their white counterparts. There is also evidence that African Americans are less likely to comply with their medication regimens.

To see whether this difference might contribute to racial disparities in diabetes control, researchers at Harvard Medical School in Boston reviewed the medical records of 1,806 adult patients in their health system with type 2 diabetes.

In general, the study found that black patients had a higher average blood sugar level than white patients did one year after starting drug therapy. They were also somewhat less likely to comply with their medication regimen, which was gauged by how often the patients refilled their prescriptions.

This did not, however, fully explain black patients' poorer blood sugar control, the researchers report in the journal Diabetes Care.

Exactly what does explain the racial gap remains an open question, according to the researchers, led by Dr. Alyce S. Adams.

One possibility, they suggest, is that African Americans tend to have more severe diabetes by the time they are diagnosed and treated. So they may need more intensive treatment off the bat, including higher medication doses.

Whatever the reasons for the racial disparities, the researchers conclude, it is unlikely that improving black patients' medication adherence will be enough to close the race gap.

More research is needed to examine possible environmental and genetic factors that may contribute to the problem of blood glucose control among African Americans with diabetes.

SOURCE: Diabetes Care, May 2008.

Migraine Medications May Cause 'Serotonin Syndrome'

By Serena Gordon
HealthDay Reporter Wed May 14, 11:46 PM ET

WEDNESDAY, May 14 (HealthDay News) -- A commonly used migraine medication may cause so-called serotonin syndrome in rare cases, new research suggests.

Reporting in the May 15 issue of the New England Journal of Medicine, researchers from Georgetown University and the U.S. Food and Drug Administration detail 11 cases of serotonin syndrome associated with the use of triptans alone that were reported to the FDA's Adverse Event Reporting System (AERS).

"The FDA has already issued an advisory and an alert that when triptans are used in combination with SSRIs, there is a possibility of serotonin syndrome. The news here is that it doesn't have to be in combination, triptans alone can cause serotonin syndrome," said the study's lead author, Offie Soldin, an associate professor of medicine and oncology at Georgetown University Medical Center.

Serotonin syndrome occurs when there is too much of the neurotransmitter serotonin, often because more than one medication that affects serotonin levels has been taken, according to the U.S. National Institutes of Health (NIH). Symptoms of serotonin syndrome include mental status changes, overactive reflexes, muscle spasms, fever, uncoordinated movements, heavy sweating and nausea or vomiting.

People with migraine headaches may be especially at risk, because medications taken to prevent migraines from occurring -- such as Zoloft, Paxil, Lexapro and Prozac -- are from a class of medications known as selective serotonin reuptake inhibitors (SSRIs), and they make serotonin more available in brain cells, called neurons. Additionally, the medications used to treat an oncoming or active migraine, such as Imitrex, Zomig, Frova, Maxalt and Axert, are from a class of medications known as triptans, which are selective serotonin receptor agonists, and can also make serotonin more available in your body. Other medications, such as older antidepressants, can also increase the levels of serotonin.

Serotonin syndrome is most likely to occur when you've just started serotonin-altering medications, according to the NIH.

Soldin and Dr. Joseph Tonning from the FDA, reviewed reports of serotonin syndrome from the AERS and found 27 cases of serotonin syndrome linked to the use of SSRIs and triptans.

The surprise for them was when they also found 11 cases of serotonin syndrome associated with triptan therapy alone.

The average age for someone experiencing serotonin syndrome associated only with triptan therapy was 39.9 years, and the most common symptoms included tremor, stiffness, palpitations, high blood pressure and agitation, according to the study.

Five people required hospitalization, and two cases were classified as "life-threatening." Four of the 11 cases cleared up within an hour of treatment.

"It's very rare and not likely to happen," said Soldin of serotonin syndrome. "And, you just need to stop taking the drugs when it does happen. If you're taking these medications and you have strange muscular, mental or hyperactivity symptoms, contact your doctor."

But, Soldin also pointed out that the FDA's reporting system is voluntary, so the actual incidence of serotonin syndrome may be higher.

Dr. Bruce Silverman, a neurologist at Providence Hospital and Medical Center in Southfield, Mich., said, "This is something to be aware of, but it's not a contraindication for triptans. These are very common drugs that have really improved people's lives, and so, many people are on these medications."

"The potential for this problem to occur is out there, but the numbers we've seen are really, really quite small; it's such a remote possibility," he added.

source:news.yahoo.com

Common Drug Eases Leg Pain From Walking

Wed May 14, 11:46 PM ET

WEDNESDAY, May 14 (HealthDay News) -- The prescription drug naftidrofuryl eases leg cramps caused by narrowing blood vessels and enables patients to walk farther, according to Belgian researchers.

They reviewed seven studies of 1,266 people with the painful condition called intermittent claudication. Patients who took the typical 200-milligram dose of naftidrofuryl (which relaxes blood vessels) three times a day for six months could walk about 40 percent farther without pain than those who took a placebo. More than half the patients who took the drug improved their walking distance by more than 50 percent, compared to just over one-third of patients who took a placebo. On average, patients who took the drug walked about 93 more yards.

The findings were published in the current issue of the Cochrane Library journal.

"Being able to walk that extra distance and have less pain makes an important, meaningful difference for these patients," study author Dr. Tine De Backer, a cardiologist at the Heart Center and at the Heymans Institute of Pharmacology at Ghent University, said in a prepared statement.

Naftidrofuryl only treats the type of leg cramping that's a symptom of intermittent claudication, but not the cause of the condition, which is peripheral artery disease (PAD), De Backer noted.

PAD is hardening and narrowing of the blood vessels typically associated with diabetes, smoking, high blood pressure, a sedentary lifestyle, elevated blood lipids and aging. PAD affects one in 20 Americans over age 50, according to the U.S. National Heart, Lung, and Blood Institute. People with type 2 diabetes have an especially high risk of PAD and intermittent claudication.

While naftidrofuryl can help patients with intermittent claudication, the review authors emphasized that quitting smoking, getting more exercise and eating a healthy diet are the first line of defense against PAD and resulting intermittent claudication.

However, doctors should prescribe naftidrofuryl for intermittent claudication, "if patients cannot control their symptoms with the drug treatments they are already on, and if they are still in pain after making lifestyle modifications," De Backer said.

Cancer drug sales could hit $80 billion by 2011: IMS

Thu May 15, 2:04 AM ET

NEW YORK (Reuters) - Sales of cancer drugs will grow at nearly double the rate of the global pharmaceutical market and could reach $80 billion by 2012, according to IMS Health, which tracks prescription drug sales.

Expensive new treatments, an increasing number of patients on chemotherapy in major markets and evidence that more people in emerging markets are gaining access to modern targeted therapies will contribute to sales of cancer drugs growing at a compound rate of 12 to 15 percent, IMS said.

In 2008, sales of oncology products will exceed $48 billion, contributing nearly 17 percent of global pharmaceutical sales growth this year, according to the IMS Global Oncology Forecast released on Thursday.

"Double-digit sales growth in oncology drugs will be fueled by increased use of targeted therapeutic agents introduced over the past 10 years, along with first-time innovations coming to the market and longer treatment periods for growing numbers of patients," Titus Plattel, IMS vice president for oncology, said in a statement.

IMS expects growth to be fueled by the introduction of 25 to 30 new chemical entities between 2008 and 2012, as expensive new biotechnology drugs and the increasing use of combination therapies contribute to the exploding cost of treatment.

Data from clinical studies of many of the newest cancer drugs will be presented and discussed at the nation's largest oncology meeting later this month in Chicago. Much of the data will be unveiled on Thursday ahead of the American Society of Clinical Oncology meeting.

Several factors could serve to moderate growth over the next five years, IMS said. They include financial constraints of payers, slowing growth of some current blockbuster therapies and patent expirations of four cancer drugs with annual sales exceeding $1 billion, including Eli Lilly's Gemzar and Taxotere from Sanofi-Aventis .

(Reporting by Bill Berkrot; editing by Carol Bishopric)
Source : news.yahoo.com

Mutant mice show new pathway in drug addiction

Wed May 21, 1:09 PM ET

PARIS (AFP) - Scientists experimenting with genetically-modified mice said on Wednesday they had unveiled a molecular pathway that helps explain drug addiction and appetite.

The discovery focuses on the chemical process by which people become substance-dependent, according to the study, published by the British journal Nature.

Pleasure-giving drugs such as cocaine and heroine -- as well as food -- work by boosting levels of a messenger chemical called dopamine that stimulates the brain's "reward" centre.

But dopamine itself is only one part of a molecular cascade that leads to dependence.

Researchers led by Jean-Antoine Girault of the Pierre and Marie Curie University in Paris looked at a brain protein called DARPP-32 which helps the dopamine signalling process.

The team found that when lab mice were given a jolt of cocaine, amphetamine or morphine, DARPP-32 built up in part of the brain called the striatum.

They then created mice whose DNA had been modified so that the gene expressing DARPP-32 turned out a slightly altered form of this protein -- a form where just one amino acid building-block had been changed.

Mutant mice and wild mice were given two shots of cocaine or morphine seven days apart. The drugs had far less effect on the engineered mice, as shown in their movement, and these rodents were far less likely to crave another dose.

Just as interesting was the discovery that mutant mice trained to use their noses to poke a lever mechanism that delivered a food pellet were far less likely to push for the reward compared with their wild counterparts.

"Taken together these results show that (the) mutation... alters long-lasting responses to drugs of abuse, and decreases motivation for food reward," the study says.

Finding a pharmaceutical drug that can block the accumulation of DARPP-32 is a promising avenue for tackling addictions as well as certain kinds of mental illness in which dopamine is suspected to play a role.

Knowledge gained from this work could also help fine-tune treatment for Parkinson's disease, which is caused by dopamine depletion, France's National Institute for Health and Medical Research (Inserm) said in a press release.

New safety program to monitor Medicare drug use

By KEVIN FREKING, Associated Press Writer Thu May 22, 6:11 PM ET

WASHINGTON - Federal health officials will begin monitoring prescription drug usage by millions of Medicare participants in an effort to identify potential safety problems.

The Food and Drug Administration has been under increasing pressure to develop a comprehensive drug surveillance system since the painkiller Vioxx was pulled from the market in 2004 after it was linked to increased risk of stroke and heart attack.

New regulations announced Thursday by the Health and Human Services Department will enable the FDA, states and academic researchers to screen the Medicare claims data. Under the regulation, the Medicare data can be made available in 30 days.

Medicare beneficiaries use an average of 28 prescriptions a year, and those who consider themselves in poor health have an average of 45 prescriptions annually, giving investigators a huge database of health records to tap into.

Officials said they no longer would have to wait years to see how a drug or medical device affects millions of people.

"The era of wait and see is going to become the era of tell me right now," the FDA commissioner, Dr. Andrew von Eschenbach, said.

The Institute of Medicine recommended creation of such a surveillance system in 2006. Personally identifying information will stay inside the Medicare agency and will not be part of the information that the FDA and others look at, officials said.

The FDA primarily relies on physicians and patients to report suspected adverse events. Often, it takes a number of cases before someone at the agency detects a pattern that's worth investigating. Then it conducts an investigation to determine whether the side effects were caused by the drug. At the first hint of trouble, the FDA now will be able to query databases involving tens of millions of patients. It will not only be able to see the medications used, but also whether a patient had lab work done or whether they had to be hospitalized.

The first batch of records the agency will have at its disposal will be from 25 million Medicare beneficiaries. Later, private companies will contribute medical data, Health and Human Services Secretary Mike Leavitt said.

"We're moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products currently on the market," Leavitt said.

Officials provided only general details about the cost of enacting what the FDA has labeled the Sentinel Initiative. The agency is hiring more staff, but it won't need a large new computer system, officials said. That's because agencies such as the Centers for Medicare and Medicaid Services will use their own computer systems to do the data-mining. The FDA will simply provide the questions while Medicare's computers supply the answer.

Medicare officials said the program could end up reducing the government's health costs if it can cut down on adverse drug events. The cost of treating preventable adverse events in Medicare comes to about $900 million a year. Also, officials said they will be able to determine when a drug is being inappropriately dispensed to treat certain conditions. By promoting best practices in therapy management, agency officials said they hope to cut down on unnecessary prescription bills.

Dr. Mark McClellan, a senior fellow at the Brookings Institution and a former Medicare administrator, said the new data mining system was actually a good model for maintaining patient privacy. The personal data stays where it was, with an insurer or within a medical practice, or within Medicare. The FDA doesn't need personally identifying information to help it monitor medical practices, he said.

"You don't have to share with the FDA a whole lot of detailed personal information about each case," McClellan said. "What FDA mainly needs to know is what's going on in the population being treated by all these different components of our health care system."

Rep. Rosa DeLauro, D-Conn., said she was glad the FDA was laying the groundwork for the surveillance system. But she said the effort has taken too long and that it's still just in the planning stages.

Von Eschenbach said a pilot project allowing the FDA to look at Medicare data could begin after 30 days.

"We're here today not to simply announce a concept, but to launch what is the next phase for the FDA in post-market surveillance," he said.
Source: news.yahoo.com

U.S. unveils plan to track safety of drugs and devices

By Susan Heavey and Lisa Richwine Thu May 22, 6:14 PM ET

WASHINGTON (Reuters) - U.S. health officials on Thursday announced plans for a new computer tracking system designed to help them identify dangers from prescription drugs and medical devices already on the market.

The system would enable the Food and Drug Administration to search various databases for possible signs of side effects. The databases include that of the government's Medicare health insurance plan for the elderly and disabled.

The FDA's safety monitoring has been criticized as inadequate and slow, especially after Merck & Co Inc's 2004 withdrawal of painkiller Vioxx because of increased risk of heart attacks and strokes.

"We're moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market," Health and Human Services Secretary Mike Leavitt told reporters.

Called the Sentinel System, the new effort is designed to better track risks that emerge after wider use in the marketplace versus a smaller clinical trial.

"We also will learn things that will lead to new warnings, absolutely," said Dr. Janet Woodcock, head of the FDA's drugs division.

The FDA currently relies largely on reports of potential side effects from manufacturers, doctors and consumers. Cases are under-reported, because only manufacturers are required to submit them to the agency. Physicians and patients can volunteer the information to the agency.

Under the proposal, the FDA could search claims data from private health insurers, hospitals and Medicare to see if problems have occurred in patients given a particular treatment. The agency has done that on a limited basis.

"The FDA will eventually be able to query databases of tens of millions of patients almost simultaneously. It will no longer have to wait for reports to trickle in from the field," Leavitt said.

It was not clear how long it would take officials to set up the program.

The FDA plans to start by looking at information from more than 25 million patients with prescription drug coverage under Medicare. That data, which would not include patient names, would also be available to states and academic researchers, health officials said.

Consumer groups welcomed the plan as an improvement over current monitoring but said it was unclear when it would yield benefits, given the FDA's strained budget and staff.

"This is where we have to move, the sooner the better. I hope the FDA will prioritize it," said Steven Findlay, health care analyst at Consumers Union.

Useful information from Medicare patients could be available within a year, Findlay estimated, while other efforts would likely take longer.

Diana Zuckerman, president of the National Research Center for Women & Families, said the Medicare data could provide valuable insight into sick and elderly patients who are typically excluded from drug-company clinical trials.

She said questions remained about how the FDA would use the data, how much funding would be available and which findings would be made public.

The Pharmaceutical Research and Manufacturers of America, an industry group, said the effort "should improve the efficiency of post-market surveillance" and benefit patients.

The system helps fulfill requirements set forth by Congress last year to strengthen the agency's oversight and was first proposed by the Institute of Medicine in 2006.

(Reporting by Susan Heavey and Lisa Richwine, editing by Gerald E. McCormick, Leslie Gevirtz, Gary Hill)