Children and teens who took antipsychotic medicines in a study gained weight and developed increased blood-fat levels, possibly harming their future health, researchers in New York State said.
The subjects, taking the antipsychotic drugs for the first time, gained from 9.7 to 18.7 pounds (4.4 to 8.5 kilograms) after about 11 weeks of treatment, depending on which medicine they were given, the scientists said today in the Journal of the American Medical Association. Fifteen patients who didn’t stick with drugs or who declined to participate in the research gained less than half a pound on average.
The study was the largest to show how antipsychotic medicines affect the bodies of children taking the drugs for the first time, the researchers wrote. Many past studies of the drugs involved patients who had also used other treatments -- methodology that may have masked the extent of weight gain, according to an editorial published with the study.
“We were able to show all of these agents can cause quite a bit of body weight changes and body composition changes that are not beneficial to the health,” said Christoph Correll, the study’s lead author, in a telephone interview on Oct. 23.
“What we need to figure out is what are the long-term consequences in the lives of children,” Correll, who is a medical director at Zucker Hillside Hospital in New York City’s Queens borough and an associate professor of psychiatry at Yeshiva University’s Albert Einstein College of Medicine in the Bronx.
Metabolic Syndrome
Gaining weight and changes in blood sugars and fats can be precursors to metabolic syndrome, a group of risk factors linked to heart disease and diabetes, according to the research article. Weight gain, obesity and increases in cholesterol in children are linked to their adult risk of cardiovascular problems and cancer.
Patients in the study had been diagnosed with mood disorders, schizophrenia and disruptive or aggressive behavior. Their doctors had prescribed Abilify, made by New York-based Bristol-Myers Squibb Co.; Zyprexa, made by Indianapolis-based Eli Lilly & Co.; Seroquel, made by London-based AstraZeneca Plc, or Risperdal made by New Brunswick, New Jersey-based Johnson & Johnson.
Risperdal and Abilify are the only two antipsychotics approved for pediatric use. A panel of outside advisers to the U.S. Food and Drug Administration recommended in June that Seroquel, Zyprexa and New York-based Pfizer Inc.’s Geodon be cleared for pediatric use.
Impact in Children
The medicines, so-called atypical antipsychotics, were introduced for adults in the mid-1990s and marketed as having fewer neurological side effects than older drugs. The FDA has grappled with pediatric use for years because of concerns that weight gain, sleepiness and movement disorders reported as side effects in adults may be more pronounced in children.
U.S. sales of antipsychotic drugs reached $14.6 billion last year, the most for any class of medicines, according to IMS Health Inc. in Norwalk, Connecticut. Use of antipsychotic medicines by people younger than 20 years old has more than doubled since 2001, according to data compiled by Medco Health Solutions Inc. of Franklin Lakes, New Jersey.
The study reported today was conducted to determine if weight gain and other changes to the body were related to the start of a psychiatric illness or hospital admission, or to the medicines.
Prescribed for Behavior
Researchers at Zucker Hillside, and at the Feinstein Institute for Medical Research in Manhasset, New York, studied 272 people ages 4 to 19 who were prescribed the antipsychotic medicines for behavioral, mood or psychosis-related problems. The patients were followed for the first 12 weeks.
At about 11 weeks, those taking Zyprexa gained 18.7 pounds on average, compared with 13.4 for Seroquel, 11.7 for Risperdal and 9.7 for Abilify, the study showed.
“The extent and the rate of weight gain is remarkable,” said Christopher Varley, a professor in the psychiatry and behavioral sciences department at the University of Washington in Seattle, in a telephone interview on Oct. 23. “Realistically the kids were exposed to 11 or 12 weeks of medication. Some of them gained over 20 pounds.” Varley co-wrote the editorial in the journal that was published with the study.
Ten percent to 36 percent of the patients in the study became overweight or obese within 11 weeks of starting the medicine, the researchers said.
Cholesterol Increases
Those on Zyprexa had larger increases in cholesterol and blood sugars, according to the study. Those on Risperdal had rises in their levels of triglyceride, a type of fat found in the blood, without affecting their blood sugar, the researchers wrote. Those on Seroquel also had an increase in total cholesterol and triglycerides, and patients on Abilify didn’t have any significant worsening in their blood fats or blood sugars, according to the scientists.
Correll recommended that parents monitor their children’s weight and make sure the kids are eating healthy food and exercising.
Doctors in some cases should consider counseling and behavior therapy, as well as parental training, before prescribing the drugs, Correll said. Once the medicines are given to children and adolescents, doctors need to frequently monitor the weight gain and the patients’ blood sugars and blood fats, he said.
In the editorial accompanying the study, Varley wrote, “Given the risk for weight gain and long-term risk for cardiovascular and metabolic problems, the widespread and increasing use of atypical antipsychotic medications in children and adolescents should be reconsidered.”
The study was funded partly by the U.S. National Institutes of Health, based in Bethesda, Maryland.
Showing posts with label Drugs. Show all posts
Showing posts with label Drugs. Show all posts
Wednesday, October 28, 2009
Friday, October 23, 2009
U.S. drug labels omit vital data
In a shocking revelation, two prominent doctors have revealed that most of the times key information telling about the extent of side-effects or the effectiveness of the medicines is excluded from the drug labels in the country.
Because of the omission of important information, the drug ultimately is presented in a way that makes it seem safer and more effective than it actually is. This was written by the doctors in a commentary in the New England Journal of Medicine.
Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire, wrote, “Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”
The labels on various medicines are actually written by the manufacturers and the FDA finally gives a stamp of approval after discussing the wording.
However, some relevant information might be missing, said Woloshin. He questioned, “How can I decide if the potential harms of this drug are worth the risk if I don’t know how well the drug works, and vice versa?”
Examples of drug labels where key information was missing
Citing one of the numerous examples, the doctors quoted the case of Sepracor’s four-year-old sleep drug Lunesta that was promoted with an advertising campaign that cost a whopping $750,000 per day in 2007.
The company benefited very much and generated sales of $600 million last year. It even became a wholly-owned subsidiary of Dainippon Sumitomo Pharma Co Tuesday.
The label on the drug only said that Lunesta was superior to a placebo and nothing else was specified.
However, when the tests were conducted and the results were given to the FDA, it came to light that “Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning,” wrote Schwartz and Woloshin.
Another such case in point is that of Takeda Pharmaceutical Co’s insomnia drug Rozerem. The label on the drug did not mention that laboratory statistics have revealed that it still took 31 minutes for adults above 64 years of age, and 24 minutes for younger adults to fall asleep once they consumed the drug.
Not only this, when clinical trials were conducted, the volunteers reported “no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep.” But all this information was not mentioned on the drug label, the researchers said.
Schwartz and Woloshin stressed in their commentary, “Sometimes what gets lost is data on harms.”
New system to make drug labels clearer in content
Woloshin believes that he and his colleagues have found a better system that can help in clarifying the extent of the dangers and benefits of the drugs to the consumers.
The FDA’s Risk Advisory Committee is also in favor of the new system and the matter will be further discussed next month.
Because of the omission of important information, the drug ultimately is presented in a way that makes it seem safer and more effective than it actually is. This was written by the doctors in a commentary in the New England Journal of Medicine.
Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire, wrote, “Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles.”
The labels on various medicines are actually written by the manufacturers and the FDA finally gives a stamp of approval after discussing the wording.
However, some relevant information might be missing, said Woloshin. He questioned, “How can I decide if the potential harms of this drug are worth the risk if I don’t know how well the drug works, and vice versa?”
Examples of drug labels where key information was missing
Citing one of the numerous examples, the doctors quoted the case of Sepracor’s four-year-old sleep drug Lunesta that was promoted with an advertising campaign that cost a whopping $750,000 per day in 2007.
The company benefited very much and generated sales of $600 million last year. It even became a wholly-owned subsidiary of Dainippon Sumitomo Pharma Co Tuesday.
The label on the drug only said that Lunesta was superior to a placebo and nothing else was specified.
However, when the tests were conducted and the results were given to the FDA, it came to light that “Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning,” wrote Schwartz and Woloshin.
Another such case in point is that of Takeda Pharmaceutical Co’s insomnia drug Rozerem. The label on the drug did not mention that laboratory statistics have revealed that it still took 31 minutes for adults above 64 years of age, and 24 minutes for younger adults to fall asleep once they consumed the drug.
Not only this, when clinical trials were conducted, the volunteers reported “no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep.” But all this information was not mentioned on the drug label, the researchers said.
Schwartz and Woloshin stressed in their commentary, “Sometimes what gets lost is data on harms.”
New system to make drug labels clearer in content
Woloshin believes that he and his colleagues have found a better system that can help in clarifying the extent of the dangers and benefits of the drugs to the consumers.
The FDA’s Risk Advisory Committee is also in favor of the new system and the matter will be further discussed next month.
As genetic medicine races ahead, docs are left behind
Genetic tests that can help predict and refine a patient's response to drug therapy may be the first big thing in personalized medicine. But the vast majority of physicians don't know how to use them, a new survey finds.
Individual genetic variations can affect how a patient will respond to many antidepressants, pain medications, cardiovascular medicines and certain drugs that treat cancers and gastrointestinal ailments. In all, roughly one in four American patients take medications whose effectiveness could be tweaked or predicted by a pharmacogenetic test. And purveyors of genomic testing services and devices are rushing to provide tests for them all.
A survey of more than 10,000 U.S. physicians undertaken by the American Medical Assn. and the pharmacy benefits manager Medco Healthcare Solutions Inc. found that just more than one in four had had any type of education in the use of genetic testing to guide medication decisions. And only 1 in 10 felt he or she had the necessary training and knowledge to put pharmacogenetic testing to good use in treating patients. Some 13% had ordered or recommended a genetic test for a patient in the last six months. But twice that many said they would do so in the next six months.
Genes that regulate liver enzymes can have a particularly powerful influence on a patient's response to a medication. Scientists believe that one such enzyme may be responsible for governing the way patients respond to some 30% of all drugs used today. In oncology, a test can help predict if breast cancer patients will respond to the drug tamoxifen. And cancer drugs in the development pipeline are expected overwhelmingly to be administered with the guidance of genetic tests. Genetic tests also can help reduce unwanted side effects; the blood thinner warfarin, for instance, can cause blood clots or serious bleeds in some patients with an identified genetic variance, and physicians are increasingly testing those on a blood-thinning regimen in an effort reduce such risks.
"It's clear there's wide acceptance" on physicians' part for the role that genetic testing can play in guiding medication decisions, said Dr. Robert Epstein, Medco's chief medical officer, who briefed physicians and researchers on the survey at the annual meeting of the American Society for Human Genetics on Thursday. But the AMA and other groups must step up efforts to educate physicians in the use of these tests, added Epstein. "With the number of new drugs coming to market with a companion diagnostic, it's paramount that this education takes place."
Individual genetic variations can affect how a patient will respond to many antidepressants, pain medications, cardiovascular medicines and certain drugs that treat cancers and gastrointestinal ailments. In all, roughly one in four American patients take medications whose effectiveness could be tweaked or predicted by a pharmacogenetic test. And purveyors of genomic testing services and devices are rushing to provide tests for them all.
A survey of more than 10,000 U.S. physicians undertaken by the American Medical Assn. and the pharmacy benefits manager Medco Healthcare Solutions Inc. found that just more than one in four had had any type of education in the use of genetic testing to guide medication decisions. And only 1 in 10 felt he or she had the necessary training and knowledge to put pharmacogenetic testing to good use in treating patients. Some 13% had ordered or recommended a genetic test for a patient in the last six months. But twice that many said they would do so in the next six months.
Genes that regulate liver enzymes can have a particularly powerful influence on a patient's response to a medication. Scientists believe that one such enzyme may be responsible for governing the way patients respond to some 30% of all drugs used today. In oncology, a test can help predict if breast cancer patients will respond to the drug tamoxifen. And cancer drugs in the development pipeline are expected overwhelmingly to be administered with the guidance of genetic tests. Genetic tests also can help reduce unwanted side effects; the blood thinner warfarin, for instance, can cause blood clots or serious bleeds in some patients with an identified genetic variance, and physicians are increasingly testing those on a blood-thinning regimen in an effort reduce such risks.
"It's clear there's wide acceptance" on physicians' part for the role that genetic testing can play in guiding medication decisions, said Dr. Robert Epstein, Medco's chief medical officer, who briefed physicians and researchers on the survey at the annual meeting of the American Society for Human Genetics on Thursday. But the AMA and other groups must step up efforts to educate physicians in the use of these tests, added Epstein. "With the number of new drugs coming to market with a companion diagnostic, it's paramount that this education takes place."
Wednesday, August 26, 2009
UPDATE 1-Dainippon schizophrenia drug meets trial goals
apan's Dainippon Sumitomo Pharma Co Ltd (4506.T) said its experimental schizophrenia drug, lurasidone, was significantly better than placebo in a pivotal late-stage clinical trial, according to data released on Wednesday.
The company said it plans to submit its application seeking U.S. approval to sell the medicine early next year.
Dainippon Sumitomo will decide by autumn whether it will market the new drug, if approved, via its own sales network or a co-promotion deal with another firm or if it will acquire a U.S. company, a spokesman for the mid-sized drugmaker said.
Patients with acute schizophrenia in the 478-subject, six-week, Phase III trial received either 40 milligrams or 120 milligrams of lurasidone daily or a placebo.
Both doses of the drug proved to be statistically significantly better than placebo in the primary goal of the study, which was 30 percent or better improvement in the Positive and Negative Syndrome Scale, the company said.
Fifty-three percent of patients who received 40 mg of lurasidone and 47 percent of those on the 120 mg dose achieved the primary goal compared with 38 percent on placebo.
Both doses of lurasidone were also significantly more effective than placebo on a secondary measure used to test antipsychotic drugs called the Clinical Global Impressions Severity scale, the company said.
In previous trials, lurasidone was also tested at 80 mg and Dainippon Sumitomo said it would submit all three doses for FDA approval.
Lurasidone belongs to a class of drugs known as atypical antipsychotics and works by blocking serotonin receptors in the brain. If approved, it would join an already crowded field of such treatments.
"We're still searching for the right drug for many of these patients. There's no one size fits all," Dr Herbert Meltzer, one of the study's lead investigators and professor of psychiatry at Vanderbilt University School of Medicine, said in a telephone interview.
Patients in the trial had been diagnosed with schizophrenia on average for more than 13 years and most had been previously hospitalized prior to entering the study.
"If you look at the weight gain, the lipid changes, it's among the most benign of any antipsychotic drugs, clearly better than olanzapine, clozapine and Seroquel," Meltzer said.
Olanzapine is the chemical name for Eli Lilly and Co's (LLY.N) widely-used Zyprexa; clozapine in sold by Novartis AG (NOVN.VX) under the brand name Clozaril; and Seroquel is sold by AstraZeneca Plc (AZN.L).
Zyprexa and similar drugs can cause significant weight gain and have been linked to increased risk of diabetes.
But "this class of drugs as a whole is so superior to the first generation drugs," said Meltzer, who plans to present the data from the lurasidone trial at a major medical meeting in December.
Lurasidone was well tolerated with a discontinuation rate nearly identical to placebo -- 40 percent versus 39 percent -- and the adverse events were generally mild, such as restlessness and sleepiness.
"From the point of view of efficacy and side effect profile, once a day administration, the fact that the lower dose works as well as the higher dose, I think this is going to have a very good chance of major acceptance among my colleagues," Meltzer added. (Additional reporting by Yumiko Nishitani in Tokyo; Editing by Andre Grenon and Edwina Gibbs)
The company said it plans to submit its application seeking U.S. approval to sell the medicine early next year.
Dainippon Sumitomo will decide by autumn whether it will market the new drug, if approved, via its own sales network or a co-promotion deal with another firm or if it will acquire a U.S. company, a spokesman for the mid-sized drugmaker said.
Patients with acute schizophrenia in the 478-subject, six-week, Phase III trial received either 40 milligrams or 120 milligrams of lurasidone daily or a placebo.
Both doses of the drug proved to be statistically significantly better than placebo in the primary goal of the study, which was 30 percent or better improvement in the Positive and Negative Syndrome Scale, the company said.
Fifty-three percent of patients who received 40 mg of lurasidone and 47 percent of those on the 120 mg dose achieved the primary goal compared with 38 percent on placebo.
Both doses of lurasidone were also significantly more effective than placebo on a secondary measure used to test antipsychotic drugs called the Clinical Global Impressions Severity scale, the company said.
In previous trials, lurasidone was also tested at 80 mg and Dainippon Sumitomo said it would submit all three doses for FDA approval.
Lurasidone belongs to a class of drugs known as atypical antipsychotics and works by blocking serotonin receptors in the brain. If approved, it would join an already crowded field of such treatments.
"We're still searching for the right drug for many of these patients. There's no one size fits all," Dr Herbert Meltzer, one of the study's lead investigators and professor of psychiatry at Vanderbilt University School of Medicine, said in a telephone interview.
Patients in the trial had been diagnosed with schizophrenia on average for more than 13 years and most had been previously hospitalized prior to entering the study.
"If you look at the weight gain, the lipid changes, it's among the most benign of any antipsychotic drugs, clearly better than olanzapine, clozapine and Seroquel," Meltzer said.
Olanzapine is the chemical name for Eli Lilly and Co's (LLY.N) widely-used Zyprexa; clozapine in sold by Novartis AG (NOVN.VX) under the brand name Clozaril; and Seroquel is sold by AstraZeneca Plc (AZN.L).
Zyprexa and similar drugs can cause significant weight gain and have been linked to increased risk of diabetes.
But "this class of drugs as a whole is so superior to the first generation drugs," said Meltzer, who plans to present the data from the lurasidone trial at a major medical meeting in December.
Lurasidone was well tolerated with a discontinuation rate nearly identical to placebo -- 40 percent versus 39 percent -- and the adverse events were generally mild, such as restlessness and sleepiness.
"From the point of view of efficacy and side effect profile, once a day administration, the fact that the lower dose works as well as the higher dose, I think this is going to have a very good chance of major acceptance among my colleagues," Meltzer added. (Additional reporting by Yumiko Nishitani in Tokyo; Editing by Andre Grenon and Edwina Gibbs)
Tuesday, August 18, 2009
Ibuprofen is best for kids with broken arms
Kids with a broken arm do better on a simple over-the-counter painkiller than on a more powerful prescription combination that includes a narcotic, a surprising study finds.
It tested ibuprofen, sold as Advil, Motrin and other brands, against acetaminophen plus codeine — a combo called Tylenol No. 3 that is also sold in generic form.
The children on ibuprofen did better, said the study leader, Dr. Amy Drendel of the Medical College of Wisconsin in suburban Milwaukee.
"They were more likely to play, they ate better and they had fewer adverse effects," she said.
Results were published online Tuesday by the Annals of Emergency Medicine. Experts praised the study as one of the few to compare medicines that have been long used in children based on how they work in adults.
"We want to start with what's effective and less likely to cause problems," and in this case, it turned out to be a cheap, over-the-counter drug, said Dr. Knox Todd, an emergency medicine pain researcher at Beth Israel Medical Center in New York and a member of the American Pain Society's board of directors.
The results do not mean that ibuprofen beats acetaminophen for everyday pain relief in children or anyone else, though. The study tested a specific use — pain in the first three days after a broken arm — and the acetaminophen was combined with the narcotic codeine, not tested alone.
Still, it shows the best way to treat a very common problem: As many as one out of five kids will break a bone before age 10 — often, an arm.
Researchers randomly assigned 336 children ages 4 to 18 to go home with liquid versions of either ibuprofen or the acetaminophen-codeine combo after being treated for a broken arm at Children's Hospital of Wisconsin. Neither the children, parents nor the doctors knew who received what treatment until the study ended.
Full results were available on 244 children. The portion who failed to get relief from their assigned medicine was roughly the same.
However, half of those on the combo medicine reported side effects — mostly nausea and drowsiness that can occur with narcotics like codeine — versus 30 percent of those given ibuprofen.
The ibuprofen users also had fewer problems eating, playing, going to school or sleeping. They and their parents reported more satisfaction with the treatment.
"A lot of emergency medicine physicians are afraid to give kids narcotics and a lot of parents are uncomfortable with narcotic medicine," so finding an effective alternative is good news, Drendel said.
The hospital and medical school paid for the study, and a hospital-related charity paid for $10 Toys R Us gift certificates for each participant.
The study has nothing to do with limits on Tylenol for adults that were recently proposed by an advisory panel to the federal Food and Drug Administration, said Todd, who is a member of that panel.
"Acetaminophen when taken as directed is a very safe drug. The problem is people taking too much," or its inclusion in drugs that people might not be aware of, he explained.
It tested ibuprofen, sold as Advil, Motrin and other brands, against acetaminophen plus codeine — a combo called Tylenol No. 3 that is also sold in generic form.
The children on ibuprofen did better, said the study leader, Dr. Amy Drendel of the Medical College of Wisconsin in suburban Milwaukee.
"They were more likely to play, they ate better and they had fewer adverse effects," she said.
Results were published online Tuesday by the Annals of Emergency Medicine. Experts praised the study as one of the few to compare medicines that have been long used in children based on how they work in adults.
"We want to start with what's effective and less likely to cause problems," and in this case, it turned out to be a cheap, over-the-counter drug, said Dr. Knox Todd, an emergency medicine pain researcher at Beth Israel Medical Center in New York and a member of the American Pain Society's board of directors.
The results do not mean that ibuprofen beats acetaminophen for everyday pain relief in children or anyone else, though. The study tested a specific use — pain in the first three days after a broken arm — and the acetaminophen was combined with the narcotic codeine, not tested alone.
Still, it shows the best way to treat a very common problem: As many as one out of five kids will break a bone before age 10 — often, an arm.
Researchers randomly assigned 336 children ages 4 to 18 to go home with liquid versions of either ibuprofen or the acetaminophen-codeine combo after being treated for a broken arm at Children's Hospital of Wisconsin. Neither the children, parents nor the doctors knew who received what treatment until the study ended.
Full results were available on 244 children. The portion who failed to get relief from their assigned medicine was roughly the same.
However, half of those on the combo medicine reported side effects — mostly nausea and drowsiness that can occur with narcotics like codeine — versus 30 percent of those given ibuprofen.
The ibuprofen users also had fewer problems eating, playing, going to school or sleeping. They and their parents reported more satisfaction with the treatment.
"A lot of emergency medicine physicians are afraid to give kids narcotics and a lot of parents are uncomfortable with narcotic medicine," so finding an effective alternative is good news, Drendel said.
The hospital and medical school paid for the study, and a hospital-related charity paid for $10 Toys R Us gift certificates for each participant.
The study has nothing to do with limits on Tylenol for adults that were recently proposed by an advisory panel to the federal Food and Drug Administration, said Todd, who is a member of that panel.
"Acetaminophen when taken as directed is a very safe drug. The problem is people taking too much," or its inclusion in drugs that people might not be aware of, he explained.
Wednesday, July 29, 2009
Royal Pharmaceutical Society Calls for Older People to Review Their Medicine With a Pharmacist
New research released today by the Royal Pharmaceutical Society of Great Britain (RPSGB) reveals how older people are taking a cocktail of medicine without fully understanding what they are or the side effects they are causing.
The RPSGB survey shows that nearly half (43%) of over 65's are currently taking over five medicines at any one time. However, one in five admits to not always taking the medicine as prescribed. Sixty per cent also believe that they either definitely or possibly have had a side effect from medicine - yet one if five said they did not get it checked out.
In response to these findings, the RPSGB is launching a campaign to urge older people to review the medicine they are taking by visiting their local pharmacist for a Medicine Use Review (MUR).
MURs are undertaken by local pharmacies to help patients manage their medicine more effectively and can be done on an annual basis. It involves a consultation with a pharmacist and can be offered to anyone on one or more medicines and/ or long term conditions.
Royal Pharmaceutical Society spokesman and pharmacist, Paul Johnson says; "It's not unusual for older people to get confused with the medicine they are taking, particularly when they are on numerous types of medication. As a result, they may also not realise the reactions they may be causing when they are not used properly.
"Pharmacists are easily accessible and are ideally placed to provide advice to a patient on their medicine which can really improve someone's health or even their quality of life. "
Other findings of the research revealed that almost one in 10 (9%) admit to not fully understanding what their medications do or how they treat their condition, and one in seven (14%) say they sometimes forget to take a pill at the recommended time.
Notes to Editor
Royal Pharmaceutical Society of Great Britain
The Royal Pharmaceutical Society of Great Britain (RPSGB) is the professional and regulatory body for pharmacists in England, Scotland and Wales. It also regulates pharmacy technicians on a voluntary basis, which will become statutory from 1 July 2009. The primary objectives of the RPSGB are to lead, regulate, develop and represent the profession of pharmacy.
The RPSGB leads and supports the development of the profession within the context of the public benefit. This includes the advancement of science, practice, education and knowledge in pharmacy. In addition, it promotes the profession's policies and views to a range of external stakeholders in a number of different forums.
Following the publication in 2007 of the Government White Paper Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century, the RPSGB is working towards the demerger of its regulatory and professional roles. This will see the establishment of a new General Pharmaceutical Council and a new professional body for pharmacy in 2010.
The YouGov survey was undertaken by the Royal Pharmaceutical Society between July 20 and 22 and had a sample size of 2,145 Great Britain Adults.
The RPSGB survey shows that nearly half (43%) of over 65's are currently taking over five medicines at any one time. However, one in five admits to not always taking the medicine as prescribed. Sixty per cent also believe that they either definitely or possibly have had a side effect from medicine - yet one if five said they did not get it checked out.
In response to these findings, the RPSGB is launching a campaign to urge older people to review the medicine they are taking by visiting their local pharmacist for a Medicine Use Review (MUR).
MURs are undertaken by local pharmacies to help patients manage their medicine more effectively and can be done on an annual basis. It involves a consultation with a pharmacist and can be offered to anyone on one or more medicines and/ or long term conditions.
Royal Pharmaceutical Society spokesman and pharmacist, Paul Johnson says; "It's not unusual for older people to get confused with the medicine they are taking, particularly when they are on numerous types of medication. As a result, they may also not realise the reactions they may be causing when they are not used properly.
"Pharmacists are easily accessible and are ideally placed to provide advice to a patient on their medicine which can really improve someone's health or even their quality of life. "
Other findings of the research revealed that almost one in 10 (9%) admit to not fully understanding what their medications do or how they treat their condition, and one in seven (14%) say they sometimes forget to take a pill at the recommended time.
Notes to Editor
Royal Pharmaceutical Society of Great Britain
The Royal Pharmaceutical Society of Great Britain (RPSGB) is the professional and regulatory body for pharmacists in England, Scotland and Wales. It also regulates pharmacy technicians on a voluntary basis, which will become statutory from 1 July 2009. The primary objectives of the RPSGB are to lead, regulate, develop and represent the profession of pharmacy.
The RPSGB leads and supports the development of the profession within the context of the public benefit. This includes the advancement of science, practice, education and knowledge in pharmacy. In addition, it promotes the profession's policies and views to a range of external stakeholders in a number of different forums.
Following the publication in 2007 of the Government White Paper Trust, Assurance and Safety - The Regulation of Health Professionals in the 21st Century, the RPSGB is working towards the demerger of its regulatory and professional roles. This will see the establishment of a new General Pharmaceutical Council and a new professional body for pharmacy in 2010.
The YouGov survey was undertaken by the Royal Pharmaceutical Society between July 20 and 22 and had a sample size of 2,145 Great Britain Adults.
Monday, July 27, 2009
BioScrip expansion to offer injectable medicine
Despite a difficult economy, BioScrip, a Columbus-based pharmaceutical company, is continuing its expansion with the addition of an ambulatory infusion center.
The center, which will allow patients to receive injectable medications at the BioScrip facility rather than going to a hospital or clinic, is tentatively set to open in early 2010.
The company's growth mirrors the overall health-care industry, which has been able to avoid the worst effects of the downturn.
The expansion also includes a renovation of the company's specialty pharmacy operation, which mails out approximately 6,000 prescriptions daily nationwide. Both the center and pharmacy are in Hilliard.
The opening of the infusion center, however, also will signal BioScrip's switch to an open pharmacy, meaning patients will have the additional option of being able to go to the facility to pick up their medication.
"It helps to reduce the cost and adds convenience for patients," said Russ Corvese, executive vice president of mail operations. "Many of them need these medications on a frequent basis."
Dr. Erick Arce, a neurologist with Neurological Associations in Columbus, treats patients with multiple sclerosis and chronic headaches who use infusions. He said giving patients access to these medications outside a hospital can be convenient for those who live outside the city and have trouble getting around.
"They have the ability to be more flexible," Arce said. "But there are typically no physicians on-site, and if there are complications, the patient will probably end up at the emergency room when maybe they didn't need to be."
The mail-order operations remain BioScrip's main business. The company has grown from 40 employees to about 250 since it was created in 1994 in Rhode Island. Columbus became BioScrip's headquarters for mail-order prescriptions in 2000. It has relationships with companies whose insurance policies offer BioScrip's mail services as an option, or drug companies that make their medications available exclusively through BioScrip.
The infusion center will have specialized staff members to help with treatment and medications for diseases such as hemophilia, hepatitis C, multiple sclerosis and rheumatoid arthritis. BioScrip employs nurses and special technicians to keep in contact with these patients and check up on how their treatment is going.
Many of the injectable medicines must be mixed just before they're dispensed, Corvese said, making the care of chronic diseases difficult and burdensome, not to mention expensive. The price of medications ranges from $2,000 to $5,000.
"Some of these medications don't actually make the patient feel better" but help to manage the disease, Corvese said "We have people on hand to do side-effect management as well." Some of the medications prevent flare-ups, or an escalation to a more severe stage, he added.
For rheumatoid arthritis, many of the most effective medications are either injections or infusions, said Nicholas Turkas, director of public health for the Arthritis Foundation's central Ohio chapter.
"These kinds of medications are a quantum leap forward as far as treatment goes," Turkas said. "Anything that can increase convenience for the patients is very important."
Saturday, July 25, 2009
UPDATE 1-Sanofi's Lantus drug no cause for concern -EU agency
The European Union's drug watchdog cast further doubt on recent studies suggesting a possible cancer risk with Sanofi-Aventis's (SASY.PA) widely-used Lantus diabetes drug.
The European Medicines Agency said in a statement on Thursday its experts concluded that the available data does not provide a cause for concern and changes to how the drug should be prescribed were not necessary.
It also called on the French drugmaker to generate further research on the drug.
"Due to methodological limitations the studies were found to be inconclusive and did not allow a relationship between insulin glargine and cancer to be confirmed or excluded," the agency said in a statement, referring to the drug's generic name.
"In addition, the committee noted that the results of the studies were not consistent."
"This is important and reassuring information for patients receiving Lantus," said Jean-Pierre Lehner, the group's chief medical officer, adding the review confirmed Lantus use should continue unchanged.
Sanofi said it would take steps to develop further research in the area, in line with recommendations made recently by an independent panel.
The guidance came after the U.S. Food and Drug Administration earlier this month questioned four recently published studies over the cancer link, saying they did not track patients long enough to properly evaluate any such risk from the drug.
Sanofi has firmly stood behind its long-acting insulin medicine Lantus seen as a medicine able to offset a fall in sales of other products, such as Plavix and Lovenox, which could soon face generic competition.
Its stock dived last month when worries about a possible but uncertain link with cancer first surfaced.
he drugmaker said at the time the data was of "poor quality" and no firm conclusions could be drawn. A group of independent experts invited by Sanofi to review the studies later concluded the studies were flawed.
Lantus had sales of 2.45 billion euros ($3.5 billion) in 2008 and had been expected to continue to grow strongly, reflecting the growing incidence of diabetes worldwide.
The last big safety scare over a diabetes drug involved GlaxoSmithKline's (GSK.L) pill Avandia, linked to heart attack risk in a U.S. study in 2007. Glaxo contested those findings, but sales of the drug still halved.
Sanofi shares rose after the announcement and closed up 1.2 percent at 46.31 euros. (Reporting by Michael Kahn; Addition Reporting by Helen Massy-Beresford; Editing by David Cowell and Dan Lalor) ($1 = 0.7030 euro)
The European Medicines Agency said in a statement on Thursday its experts concluded that the available data does not provide a cause for concern and changes to how the drug should be prescribed were not necessary.
It also called on the French drugmaker to generate further research on the drug.
"Due to methodological limitations the studies were found to be inconclusive and did not allow a relationship between insulin glargine and cancer to be confirmed or excluded," the agency said in a statement, referring to the drug's generic name.
"In addition, the committee noted that the results of the studies were not consistent."
"This is important and reassuring information for patients receiving Lantus," said Jean-Pierre Lehner, the group's chief medical officer, adding the review confirmed Lantus use should continue unchanged.
Sanofi said it would take steps to develop further research in the area, in line with recommendations made recently by an independent panel.
The guidance came after the U.S. Food and Drug Administration earlier this month questioned four recently published studies over the cancer link, saying they did not track patients long enough to properly evaluate any such risk from the drug.
Sanofi has firmly stood behind its long-acting insulin medicine Lantus seen as a medicine able to offset a fall in sales of other products, such as Plavix and Lovenox, which could soon face generic competition.
Its stock dived last month when worries about a possible but uncertain link with cancer first surfaced.
he drugmaker said at the time the data was of "poor quality" and no firm conclusions could be drawn. A group of independent experts invited by Sanofi to review the studies later concluded the studies were flawed.
Lantus had sales of 2.45 billion euros ($3.5 billion) in 2008 and had been expected to continue to grow strongly, reflecting the growing incidence of diabetes worldwide.
The last big safety scare over a diabetes drug involved GlaxoSmithKline's (GSK.L) pill Avandia, linked to heart attack risk in a U.S. study in 2007. Glaxo contested those findings, but sales of the drug still halved.
Sanofi shares rose after the announcement and closed up 1.2 percent at 46.31 euros. (Reporting by Michael Kahn; Addition Reporting by Helen Massy-Beresford; Editing by David Cowell and Dan Lalor) ($1 = 0.7030 euro)
Tuesday, July 21, 2009
Earlier HIV Antiviral Treatment Can Be Cost Effective In Areas Of Limited Resources, South African Study Finds
Early initiation of lifesaving antiretroviral therapies should be the standard of care for all HIV-infected patients, even those in countries with limited medical and financial resources, according to a study led by researchers at Massachusetts General Hospital (MGH) and the Desmond Tutu HIV Centre, University of Cape Town, South Africa.
The team reports in the August 4 Annals of Internal Medicine that starting antiretroviral therapy (ART) when the level of CD4 T cells drops below a threshold of 350 per microliter of blood, compared with below 250, would prevent nearly 76,000 deaths and avert 66,000 opportunistic infections over the next five years at an estimated cost of $1,200 per year of life saved. The study's publication coincides with the International AIDS Society Conference meeting which started yesterday in Cape Town.
The study provides strong support for broadening the eligibility standards for ART in settings with sufficient access to drugs, the authors note. In the U.S. and other developed countries, ART is usually initiated when the CD4 count – a measure of immune system function – drops below 350. Recognizing that ART is both costly and can have significant side effects, the 2006 World Health Organization (WHO) treatment guidelines suggest waiting until CD4 counts drop below 200 or until patients develop AIDS-related complications.
"While those standards accommodate the limited resources and short supply of medications in many settings, the greater prevalence of tuberculosis and other opportunistic infections in places like South Africa argue for earlier treatment initiation, even before the results of ongoing clinical trials are known." says Rochelle Walensky, MD, MPH, of the MGH Division of Infectious Disease, associate professor of Medicine at Harvard Medical School, who led the study.
Definitive clinical trial findings will not be available for several years. Yet in countries like South Africa, which currently has the world's highest burden of HIV infection, information is needed today to guide treatment policies and practices. To address this need, Walensky and colleagues developed a mathematical model to simulate HIV treatment and its associated health and economic outcomes. The model calculated the additional costs of earlier treatment, its potential toxicities and its benefits, including TB prevention. It also calculated how much delaying ART would shorten patients lives and then estimated the cost per extra year of life gained – a standard measure of cost-effectiveness – of earlier ART initiation.
"The time has come to act on the information we now have, nearly all of which supports starting treatment earlier. We can re-evaluate the situation after the trials, but until those results are available, the evidence points to saving lives with earlier treatment," says co-author, Robin Wood, FCP, MMed, DTM&H, director of the Desmond Tutu HIV Centre at the Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, a leading HIV clinical research group in South Africa
Additional co-authors of the Annals of Internal Medicine report are Lindsey Wolf, Mariam Fofana, and Kenneth Freedberg, MD, MSc, MGH; Elena Losina, PhD, Brigham and Women's Hospital; Neil Martinson, MBBCh, MPH, WITS Health Consortium, Johannesburg, South Africa; A. David Paltiel, PhD, Yale University; Xavier Anglaret, MD, PhD, University of Bordeaux, France; and Milton Weinstein, PhD, Harvard School of Public Health. The study was supported by grants from the National Institute for Allergy and Infections Diseases and the Doris Duke Charitable Foundation.
The team reports in the August 4 Annals of Internal Medicine that starting antiretroviral therapy (ART) when the level of CD4 T cells drops below a threshold of 350 per microliter of blood, compared with below 250, would prevent nearly 76,000 deaths and avert 66,000 opportunistic infections over the next five years at an estimated cost of $1,200 per year of life saved. The study's publication coincides with the International AIDS Society Conference meeting which started yesterday in Cape Town.
The study provides strong support for broadening the eligibility standards for ART in settings with sufficient access to drugs, the authors note. In the U.S. and other developed countries, ART is usually initiated when the CD4 count – a measure of immune system function – drops below 350. Recognizing that ART is both costly and can have significant side effects, the 2006 World Health Organization (WHO) treatment guidelines suggest waiting until CD4 counts drop below 200 or until patients develop AIDS-related complications.
"While those standards accommodate the limited resources and short supply of medications in many settings, the greater prevalence of tuberculosis and other opportunistic infections in places like South Africa argue for earlier treatment initiation, even before the results of ongoing clinical trials are known." says Rochelle Walensky, MD, MPH, of the MGH Division of Infectious Disease, associate professor of Medicine at Harvard Medical School, who led the study.
Definitive clinical trial findings will not be available for several years. Yet in countries like South Africa, which currently has the world's highest burden of HIV infection, information is needed today to guide treatment policies and practices. To address this need, Walensky and colleagues developed a mathematical model to simulate HIV treatment and its associated health and economic outcomes. The model calculated the additional costs of earlier treatment, its potential toxicities and its benefits, including TB prevention. It also calculated how much delaying ART would shorten patients lives and then estimated the cost per extra year of life gained – a standard measure of cost-effectiveness – of earlier ART initiation.
"The time has come to act on the information we now have, nearly all of which supports starting treatment earlier. We can re-evaluate the situation after the trials, but until those results are available, the evidence points to saving lives with earlier treatment," says co-author, Robin Wood, FCP, MMed, DTM&H, director of the Desmond Tutu HIV Centre at the Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, a leading HIV clinical research group in South Africa
Additional co-authors of the Annals of Internal Medicine report are Lindsey Wolf, Mariam Fofana, and Kenneth Freedberg, MD, MSc, MGH; Elena Losina, PhD, Brigham and Women's Hospital; Neil Martinson, MBBCh, MPH, WITS Health Consortium, Johannesburg, South Africa; A. David Paltiel, PhD, Yale University; Xavier Anglaret, MD, PhD, University of Bordeaux, France; and Milton Weinstein, PhD, Harvard School of Public Health. The study was supported by grants from the National Institute for Allergy and Infections Diseases and the Doris Duke Charitable Foundation.
Monday, July 20, 2009
UPDATE 1-Drug firms offer to lower prices in Philippines
Big international pharmaceutical firms in the Philippines have offered to lower prices of dozens of best-selling drugs to stop the government imposing price controls, an industry spokesman said on Monday.
The government said it would still consider putting price ceilings on about six to seven products because the cut offered by drug companies was way below the 50 percent reduction mandated by law, Health Secretary Francisco Duque told reporters.
"We have to do what we need to do," Duque said after reviewing the proposals. "I think they have been selling medicines in this country for such a high price compared to the other countries. So, they've generated hefty profits from the Filipinos for the longest time."
He said the new prices for about 80 drug products would take effect on Aug. 15 after the president signs an executive order this week.
On Saturday, about 50 drug-makers led by the world's largest, Pfizer Inc (PFE.N) of the United States, voluntarily offered to lower prices by an average of 50 percent for about 80 drug products for illnesses such as hypertension, cancer and diabetes to beat a government deadline.
The industry's offer to cut prices could reduce sales by as much as 7-10 billion pesos ($146-208 million) a year, making it hard for smaller drug companies that produce and market three or four products to survive, said Reiner Gloor, head of the local pharmaceutical and healthcare industry group.
The Philippines passed a law in 2008 to lower medicine costs, mandating the president to impose price ceilings on commonly used drugs, which have sold for as much as 200 percent higher than in other Asian countries such as India and Thailand.
The industry opposed moves to introduce price controls, looking at the maximum retail price mechanism under the law as a form of regulation, said Gloor, adding some drugs could continue to be inaccessible to the poor unless the healthcare system was reformed.
"That sends a wrong signal for the country, which has followed free market policy," Gloor told Reuters in an interview. "We've given the president an option in making a decision on whether there should be price control or not.
"It's something the president would like to have, considering that this has become a popular issue in an interesting period we are entering in the country," Gloor said, referring to general elections in May 2010.
The Philippines imposed price controls on medicines during the 1970s when the country was under martial law before the late dictator Ferdinand Marcos was toppled by a popular uprising in 1986. (Reporting by Manny Mogato; Editing by Rosemarie Francisco)
The government said it would still consider putting price ceilings on about six to seven products because the cut offered by drug companies was way below the 50 percent reduction mandated by law, Health Secretary Francisco Duque told reporters.
"We have to do what we need to do," Duque said after reviewing the proposals. "I think they have been selling medicines in this country for such a high price compared to the other countries. So, they've generated hefty profits from the Filipinos for the longest time."
He said the new prices for about 80 drug products would take effect on Aug. 15 after the president signs an executive order this week.
On Saturday, about 50 drug-makers led by the world's largest, Pfizer Inc (PFE.N) of the United States, voluntarily offered to lower prices by an average of 50 percent for about 80 drug products for illnesses such as hypertension, cancer and diabetes to beat a government deadline.
The industry's offer to cut prices could reduce sales by as much as 7-10 billion pesos ($146-208 million) a year, making it hard for smaller drug companies that produce and market three or four products to survive, said Reiner Gloor, head of the local pharmaceutical and healthcare industry group.
The Philippines passed a law in 2008 to lower medicine costs, mandating the president to impose price ceilings on commonly used drugs, which have sold for as much as 200 percent higher than in other Asian countries such as India and Thailand.
The industry opposed moves to introduce price controls, looking at the maximum retail price mechanism under the law as a form of regulation, said Gloor, adding some drugs could continue to be inaccessible to the poor unless the healthcare system was reformed.
"That sends a wrong signal for the country, which has followed free market policy," Gloor told Reuters in an interview. "We've given the president an option in making a decision on whether there should be price control or not.
"It's something the president would like to have, considering that this has become a popular issue in an interesting period we are entering in the country," Gloor said, referring to general elections in May 2010.
The Philippines imposed price controls on medicines during the 1970s when the country was under martial law before the late dictator Ferdinand Marcos was toppled by a popular uprising in 1986. (Reporting by Manny Mogato; Editing by Rosemarie Francisco)
Wednesday, July 8, 2009
Medicine's not-so-silent killer: Drugs gone bad
Bad reactions to drugs cause the death, hospitalization or serious injury of more than 2 million people in the United States each year, including more than 100,000 fatalities, according to Public Citizen.
Adverse drug reactions are one of the leading causes of death in the country. The odds of suffering an adverse drug reaction don't just impact senior citizens -- almost half of the FDA reports of deaths and 61 percent of hospitalizations from adverse drug reactions were in people younger than 60.
According to Dr. Robert Steinbrook, who wrote an article on doctor/industry ties in the New England Journal of Medicine, it is very common for doctors to have financial ties to a company that makes drugs or devices.
"Most physicians in the United States have financial relationships with industry, ranging from the acceptance of meals to the receipt of large sums of money for consulting, speaking, or conducting research," he wrote.
Harvard Medical School plans to strengthen its conflict-of-interest rules for doctors and researchers, after an investigation into several of its faculty members. It will join Stanford University, the University of Pennsylvania, the University of California at Los Angeles and at San Francisco, and the University of Massachusetts in adopting stricter policies.
Last year, the American Medical Student Association gave Harvard an "F" on its conflict-of-interest policy because it fails to address whether companies can provide gifts for doctors and researchers. A review of its policy began after a US Senator from Iowa accused three Mass General psychiatrists of not fully disclosing payments they received from drug companies for consulting and other activities. The doctors believe they complied with the rules, but Harvard Medical School and Mass General are conducting their own investigations.
Recently, the Vermont legislature passed a law requiring drug and device makers to publicly disclose all money given to physicians, naming names and listing dollar amounts. The law, which took effect July 1, is considered one of the most vigorous state efforts to regulate the marketing of medicine. It also bans nearly all industry gifts and meals to doctors, nurses and medical staff. Makers of medical devices and drugs spend almost $3 million on marketing to health care professionals in Vermont, according to the state's attorney general.
Minnesota already requires drug companies to report payments to doctors and new regulations in Massachusetts limit gifts and call for disclosure of any payment or gift of $50 or more. However, Vermont's law goes a step farther, banning all free meals. The law also closes a loophole in pervious regulations that allowed companies to keep specific expenses private by claiming them as trade secrets.
Adverse drug reactions are one of the leading causes of death in the country. The odds of suffering an adverse drug reaction don't just impact senior citizens -- almost half of the FDA reports of deaths and 61 percent of hospitalizations from adverse drug reactions were in people younger than 60.
According to Dr. Robert Steinbrook, who wrote an article on doctor/industry ties in the New England Journal of Medicine, it is very common for doctors to have financial ties to a company that makes drugs or devices.
"Most physicians in the United States have financial relationships with industry, ranging from the acceptance of meals to the receipt of large sums of money for consulting, speaking, or conducting research," he wrote.
Harvard Medical School plans to strengthen its conflict-of-interest rules for doctors and researchers, after an investigation into several of its faculty members. It will join Stanford University, the University of Pennsylvania, the University of California at Los Angeles and at San Francisco, and the University of Massachusetts in adopting stricter policies.
Last year, the American Medical Student Association gave Harvard an "F" on its conflict-of-interest policy because it fails to address whether companies can provide gifts for doctors and researchers. A review of its policy began after a US Senator from Iowa accused three Mass General psychiatrists of not fully disclosing payments they received from drug companies for consulting and other activities. The doctors believe they complied with the rules, but Harvard Medical School and Mass General are conducting their own investigations.
Recently, the Vermont legislature passed a law requiring drug and device makers to publicly disclose all money given to physicians, naming names and listing dollar amounts. The law, which took effect July 1, is considered one of the most vigorous state efforts to regulate the marketing of medicine. It also bans nearly all industry gifts and meals to doctors, nurses and medical staff. Makers of medical devices and drugs spend almost $3 million on marketing to health care professionals in Vermont, according to the state's attorney general.
Minnesota already requires drug companies to report payments to doctors and new regulations in Massachusetts limit gifts and call for disclosure of any payment or gift of $50 or more. However, Vermont's law goes a step farther, banning all free meals. The law also closes a loophole in pervious regulations that allowed companies to keep specific expenses private by claiming them as trade secrets.
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