A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA's system of communicating these warnings is sufficiently targeted and effective.
A study published today in the Archives of Internal Medicine examines the impact of a safety warning issued by the Food and Drug Administration for commonly prescribed antipsychotic medications. The results show the warnings resulted in a decline in usage among the elderly with dementia, yet raise the question as to whether the FDA’s system of communicating these warnings is sufficiently targeted and effective.
“Because this medication class has limited evidence of benefit among the elderly with dementia and significantly increases their risk of death, the ‘right’ magnitude of decline in usage is not clear,” said University of Rochester Medical Center neurologist Ray Dorsey, M.D., the study’s lead author. “More generally, the study raises larger issues about appropriate prescribing, particularly among the elderly, and the need to improve risk communication to patients and providers.”
Safety issues frequently emerge after a drug has been introduced to the market. These concerns arise either through ongoing clinical research or adverse events reported by post-market surveillance of the drug. The FDA can act upon this information in a number of ways. It can choose to remove the drug from the market or it can issue an advisory to physicians, the strongest of which is a “black box” warning which appears on the drug label.
The authors examined the impact of these warnings on a class of drugs called atypical antipsychotics. In April 2005, the FDA issued an advisory warning that elderly patients with dementia treated with these drugs were at increased risk of death.
READ MORE @ MEDIA-NEWSWIRE
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Tuesday, January 12, 2010
Wednesday, November 18, 2009
Drug ads get scrutiny from the FDA
When patients are diagnosed with an illness, the Web is fast becoming the first place they look for information, treatment options and support groups.
Drug companies want to be part of that conversation. But they are wary of advertising online because of the Food and Drug Adminstration's vague rules about ad content and disclaimer information for Internet marketing. Afraid of violating those rules, most pharmaceutical makers have shied away from advertising specific products online, instead relying on traditional media such as TV and print ads, for which there are strict guidelines.
The online advertising industry says the lack of clarity around the rules is costing millions in potential ad revenue and is actually resulting in less information getting to consumers.
The FDA is hosting a two-day workshop, which concludes today, to discuss how drug companies should be allowed to advertise on Web sites, search engines and social media sites. (The Wall Street Journal and NPR both wrote stories on the workshop.)
READ MORE @ THE HILL
Drug companies want to be part of that conversation. But they are wary of advertising online because of the Food and Drug Adminstration's vague rules about ad content and disclaimer information for Internet marketing. Afraid of violating those rules, most pharmaceutical makers have shied away from advertising specific products online, instead relying on traditional media such as TV and print ads, for which there are strict guidelines.
The online advertising industry says the lack of clarity around the rules is costing millions in potential ad revenue and is actually resulting in less information getting to consumers.
The FDA is hosting a two-day workshop, which concludes today, to discuss how drug companies should be allowed to advertise on Web sites, search engines and social media sites. (The Wall Street Journal and NPR both wrote stories on the workshop.)
READ MORE @ THE HILL
Saturday, November 7, 2009
FDA initiative targets drug prescription, dosing errors
The Food and Drug Administration wants to reduce the misuse of medications, saying that at least 50,000 hospitalizations a year could be prevented if physicians, pharmacists, patients and parents used greater care in dispensing and taking drugs.
"When I first started looking at this, I was stunned at the scope of the problem," FDA commissioner Margaret A. Hamburg said Wednesday as she announced the new "Safe Use" program.
The Institute of Medicine estimates that at least 1.5 million preventable injuries and deaths result each year from overdosing, mix-ups and unintended exposure to prescription drugs. Children are often the victims -- one study found that, between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs such as codeine and morphine.
The cost of these preventable injuries is estimated at about $4 billion annually by the Institute of Medicine.
READ MORE @ WASHINGTON POST
"When I first started looking at this, I was stunned at the scope of the problem," FDA commissioner Margaret A. Hamburg said Wednesday as she announced the new "Safe Use" program.
The Institute of Medicine estimates that at least 1.5 million preventable injuries and deaths result each year from overdosing, mix-ups and unintended exposure to prescription drugs. Children are often the victims -- one study found that, between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs such as codeine and morphine.
The cost of these preventable injuries is estimated at about $4 billion annually by the Institute of Medicine.
READ MORE @ WASHINGTON POST
Wednesday, October 28, 2009
Prescribing drugs 'off-label': an ethical prescription
More than one in five of the prescriptions U.S. doctors write for 160 common drugs is for a use other than that approved by the Food and Drug Administration. The practice is perfectly legal, though patients are largely in the dark about what "indications" or uses the FDA has approved for different prescription medications. (You can, however, always check the FDA-approved product labels for a prescription drug here.).
These "off-label uses" have not been scrutinized by the FDA for safety and effectiveness. It's not legal for drug companies actively to promote a drug for "off-label" purposes. But the practice means big money for drug makers, and some do it anyway (just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).
So, while it's legal, the practice is controversial.
That leaves doctors, who often feel immense pressure to offer something--anything--to relieve a patient's suffering, in uncharted ethical waters. In some cases, the "off-label" use of a drug might be just the treatment the patient needed. But it might just as likely be a waste of time and money--or worse, pose unpredictable dangers to the patient. When "everybody's doing it" (and, yes, even physicians say stuff like that sometimes), what's a physician to do?
READ MORE @ LOS ANGELES TIMES
These "off-label uses" have not been scrutinized by the FDA for safety and effectiveness. It's not legal for drug companies actively to promote a drug for "off-label" purposes. But the practice means big money for drug makers, and some do it anyway (just last month, Pfizer agreed to plead guilty to promoting off-label uses for some of its medications and was fined $2.3 billion by the Justice Department, according to the Justice Department website).
So, while it's legal, the practice is controversial.
That leaves doctors, who often feel immense pressure to offer something--anything--to relieve a patient's suffering, in uncharted ethical waters. In some cases, the "off-label" use of a drug might be just the treatment the patient needed. But it might just as likely be a waste of time and money--or worse, pose unpredictable dangers to the patient. When "everybody's doing it" (and, yes, even physicians say stuff like that sometimes), what's a physician to do?
READ MORE @ LOS ANGELES TIMES
Saturday, October 17, 2009
Should Michigan repeal immunity law for drug industry? Even after a felony plea, residents can't sue
Recently we learned that the Department of Justice will fine Pfizer $2.3 billion in civil and criminal penalties for its illegal marketing of the drugs Bextra, Zyvox, Geodon and Lyrica. This is not only the largest penalty ever levied against a drug company. It is the largest penalty ever levied against any company in American history.
That is saying something.
Pfizer and its subsidiary entities -- the former Upjohn and Pharmacia -- not only promoted these drugs for uses that were not approved by the FDA. They also marketed the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer's off-label marketing scheme amounts to negligent homicide.
That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In most instances, companies plea-bargain to misdemeanor admissions, fines are levied, and that is the end of it.
READ MORE @ DETROT FREE PRESS
That is saying something.
Pfizer and its subsidiary entities -- the former Upjohn and Pharmacia -- not only promoted these drugs for uses that were not approved by the FDA. They also marketed the drugs for uses that were explicitly rejected by the FDA, primarily because of safety concerns. To the degree that patients were killed or injured as a result, Pfizer's off-label marketing scheme amounts to negligent homicide.
That is probably why Pfizer was compelled to plead guilty to felony charges, which is also unprecedented in such contexts. In most instances, companies plea-bargain to misdemeanor admissions, fines are levied, and that is the end of it.
READ MORE @ DETROT FREE PRESS
Sunday, October 11, 2009
FDA Eases Rules on Access to Investigational Psychotropic Drugs
The FDA’s new rule on “expanded access programs” would allow pharmaceutical companies to give seriously ill patients broader access to investigational drugs outside of clinical trials. A limited number of expanded access programs were created in the past under sketchy FDA rules; the 2 new allied rules—one on the conditions drug companies must meet to create a program, the other on how they can charge for the drugs—ostensibly give pharma a wider berth. Moreover, psychotropic drugs can be provided under the clarified policy.
When the FDA was considering changes to its policy (in part prompted by a lawsuit), it contended with the issue of whether the use of psycho-tropic drugs fits in the definition of “serious medical condition”—with which a patient must be afflicted before a drug company can make an investigational agent available outside a clinical trial. The health insurance industry made an effort to convince the FDA to exclude mental health conditions from serious medical conditions.
In her comments to the FDA after the agency proposed a rule in March 2007, Karen Ignagni, president and CEO of America’s Health Insurance Plans (AHIP), pressed the agency to include a definition in the final rule that said, “A serious disease or condition is one which is persistent, substantially disabling, progressive, and likely to result in death within 6 to 12 months.” She noted that schizophrenia and chronic depression are among the conditions that “cause disabling health effects and suffering for a period of time without death occurring prematurely or in a matter of months.” AHIP was concerned about exposure of its insurance company members to wide claims from policy holders for reimbursement for expensive, investigational drugs obtained through expanded access programs, which might multiply because of the FDA rule liberalization.
READ MORE @ PSYCHIATRIC TIMES
When the FDA was considering changes to its policy (in part prompted by a lawsuit), it contended with the issue of whether the use of psycho-tropic drugs fits in the definition of “serious medical condition”—with which a patient must be afflicted before a drug company can make an investigational agent available outside a clinical trial. The health insurance industry made an effort to convince the FDA to exclude mental health conditions from serious medical conditions.
In her comments to the FDA after the agency proposed a rule in March 2007, Karen Ignagni, president and CEO of America’s Health Insurance Plans (AHIP), pressed the agency to include a definition in the final rule that said, “A serious disease or condition is one which is persistent, substantially disabling, progressive, and likely to result in death within 6 to 12 months.” She noted that schizophrenia and chronic depression are among the conditions that “cause disabling health effects and suffering for a period of time without death occurring prematurely or in a matter of months.” AHIP was concerned about exposure of its insurance company members to wide claims from policy holders for reimbursement for expensive, investigational drugs obtained through expanded access programs, which might multiply because of the FDA rule liberalization.
READ MORE @ PSYCHIATRIC TIMES
Tuesday, August 11, 2009
Antidepressant suicide risk varies by age: FDA
People under age 25 who take antidepressants have a higher risk of suicide, but adults older than that do not, an analysis by U.S. Food and Drug Administration researchers released on Tuesday showed.
The report by the FDA scientists confirms earlier studies and supports the agency's age-related warnings on the drugs' labeling.
U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.
In February 2005, the FDA added a so-called black box warning -- the agency's strongest warning -- on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.
Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment for depression, the leading cause of suicide. In fact, recent studies have suggested the warnings triggered an 8 percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years.
READ MORE @ REUTERS
The report by the FDA scientists confirms earlier studies and supports the agency's age-related warnings on the drugs' labeling.
U.S. and European regulators have been sounding alarms on the use of antidepressant drugs since 2003 after clinical trials showed they increased the risk of suicidal thoughts and behaviors in those under age 18.
In February 2005, the FDA added a so-called black box warning -- the agency's strongest warning -- on the use of all antidepressants in young children and teens to draw attention to the possible risks of these medications. In May 2007, it extended the warnings to young adults aged 18 to 24.
Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment for depression, the leading cause of suicide. In fact, recent studies have suggested the warnings triggered an 8 percent rise in suicide among youth and teens in 2004, the biggest one-year gain in 15 years.
READ MORE @ REUTERS
Monday, July 6, 2009
How does direct to consumer advertising affect the cost of medications
When one looks at television, a newspaper or a magazine it is impossible not to be inundated with ads for various prescription drug medications. This was not always the case. In fact, not until 1997, when the FDA issued its guidelines for direct to consumer advertising, did this massive pharmaceutical advertising expenditure begin.
It might interest some to know that only 2 countries in the world allow our brand of direct to consumer advertising of prescription drugs: the United State and New Zealand.
The amounts of money involved are staggering. A study done by the Kaiser Family Foundation in 2006 found that for every dollar a drug company spent on advertising, it earned $4 in additional sales. Doesn’t sound like much, does it?
But the real numbers put the impact in prospective. In 1999, just two years after the FDA permitted direct to consumer advertising in its current form, Pfizer spent 55 million advertising it’s cholesterol lowering drug, Lipitor. Sales of Lipitor jumped 56% that year to almost $2.6 billion.
As advertising spending went up, the amount of control exercised by the FDA fell. According to the New England Journal of Medicine, the FDA sent 142 violations letters to pharmaceutical companies in 1997. By 2006 the FDA sent only 21 violation letters.
READ MORE @ EXAMINER.COM
It might interest some to know that only 2 countries in the world allow our brand of direct to consumer advertising of prescription drugs: the United State and New Zealand.
The amounts of money involved are staggering. A study done by the Kaiser Family Foundation in 2006 found that for every dollar a drug company spent on advertising, it earned $4 in additional sales. Doesn’t sound like much, does it?
But the real numbers put the impact in prospective. In 1999, just two years after the FDA permitted direct to consumer advertising in its current form, Pfizer spent 55 million advertising it’s cholesterol lowering drug, Lipitor. Sales of Lipitor jumped 56% that year to almost $2.6 billion.
As advertising spending went up, the amount of control exercised by the FDA fell. According to the New England Journal of Medicine, the FDA sent 142 violations letters to pharmaceutical companies in 1997. By 2006 the FDA sent only 21 violation letters.
READ MORE @ EXAMINER.COM
Sunday, June 7, 2009
FDA Reverses Earlier Decision, Approves Schizophrenia Drug
The new antipsychotic medication has pharmacological and clinical profiles similar to those of other second-generation drugs on the market and appears to carry comparable risks.
After being turned down by the Food and Drug Administration (FDA) almost a year ago, iloperidone has gained approval for the acute treatment of schizophrenia in adult patients.
Iloperidone is a second-generation antipsychotic (SGA) medication mixed antagonism for dopamine D2 and serotonin 5HT2A receptors and is owned by Vanda Pharmaceuticals.
In two randomized, placebo-controlled, phase-3 trials in patients with schizophrenia, iloperidone was found more efficacious than placebo in reducing schizophrenia symptoms among study subjects.
In one trial, 604 patients with schizophrenia received iloperidone 24 mg/day, placebo, or ziprasidone for four weeks, with patients on iloperidone showing significant benefits in Positive and Negative Syndrome Scale total scores compared with placebo. In the other trial, involving 706 patients, iloperidone was compared with placebo and risperidone. After six weeks, the drug was superior to placebo in the reduction of total score on the Brief Psychiatric Rating Scale. The company did not release any data on how iloperidone compared with either ziprasidone or risperidone on efficacy indicators.
READ MORE @ PSYCHIATRIC NEWS
After being turned down by the Food and Drug Administration (FDA) almost a year ago, iloperidone has gained approval for the acute treatment of schizophrenia in adult patients.
Iloperidone is a second-generation antipsychotic (SGA) medication mixed antagonism for dopamine D2 and serotonin 5HT2A receptors and is owned by Vanda Pharmaceuticals.
In two randomized, placebo-controlled, phase-3 trials in patients with schizophrenia, iloperidone was found more efficacious than placebo in reducing schizophrenia symptoms among study subjects.
In one trial, 604 patients with schizophrenia received iloperidone 24 mg/day, placebo, or ziprasidone for four weeks, with patients on iloperidone showing significant benefits in Positive and Negative Syndrome Scale total scores compared with placebo. In the other trial, involving 706 patients, iloperidone was compared with placebo and risperidone. After six weeks, the drug was superior to placebo in the reduction of total score on the Brief Psychiatric Rating Scale. The company did not release any data on how iloperidone compared with either ziprasidone or risperidone on efficacy indicators.
READ MORE @ PSYCHIATRIC NEWS
Friday, June 5, 2009
Antipsychotic drugs appear to work in kids: FDA staff
Three antipsychotic drugs appear to work in children and teens but their risks must be weighed as the makers seek to promote them for younger patients, the head of the U.S. Food and Drug Administration's psychiatric division said in a memo released on Friday.
The FDA has yet to make a final decision on whether to approve drugs made by AstraZeneca, Pfizer and Eli Lilly and Co for children and teens with schizophrenia or bipolar disorder.
An FDA panel is to meet next week to give recommendations on the companies' bid to promote the drugs for children and teenagers with schizophrenia or bipolar disorder.
Doctors can already prescribe the medications for children, but FDA approval would allow the manufacturers to market them more widely.
The drugs, known as atypical antipsychotics, are widely used to treat various psychiatric conditions but have come under scrutiny for links to weight gain.
"We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness," FDA's Thomas Laughren wrote in the memo released on Friday.
He added that the safety of the drugs in children appeared "to be qualitatively similar to those observed with these drugs in adult patients."
READ MORE @ REUTERS
The FDA has yet to make a final decision on whether to approve drugs made by AstraZeneca, Pfizer and Eli Lilly and Co for children and teens with schizophrenia or bipolar disorder.
An FDA panel is to meet next week to give recommendations on the companies' bid to promote the drugs for children and teenagers with schizophrenia or bipolar disorder.
Doctors can already prescribe the medications for children, but FDA approval would allow the manufacturers to market them more widely.
The drugs, known as atypical antipsychotics, are widely used to treat various psychiatric conditions but have come under scrutiny for links to weight gain.
"We generally are in agreement that the sponsors have provided adequate support to suggest effectiveness," FDA's Thomas Laughren wrote in the memo released on Friday.
He added that the safety of the drugs in children appeared "to be qualitatively similar to those observed with these drugs in adult patients."
READ MORE @ REUTERS
Wednesday, June 3, 2009
Drug Agency May Reveal More Data on Actions
For years, the Food and Drug Administration has withheld information about transparency from the public when their makers cite trade secrecy — even in cases where the agency suspects that the products are causing serious illness or death.
Now the new leadership at the F.D.A. may change that. The Obama administration plans to announce on Tuesday that it is setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study.
The task will be complicated. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Changing them would “involve more than one Congressional committee and impact thousands and thousands of companies, and thus would be an extremely difficult legislative path,” said Peter Barton Hutt, a former general counsel to the agency.
Still, the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers.
READ MORE @ NY TIMES
Now the new leadership at the F.D.A. may change that. The Obama administration plans to announce on Tuesday that it is setting up a task force within the agency to recommend ways to reveal more information about F.D.A. decisions, possibly including the disclosure of now secret data about drugs and devices under study.
The task will be complicated. Agency confidentiality decisions are governed by several interconnected laws, including the Federal Trade Secrets Act. Changing them would “involve more than one Congressional committee and impact thousands and thousands of companies, and thus would be an extremely difficult legislative path,” said Peter Barton Hutt, a former general counsel to the agency.
Still, the goal is to open up a system in which the agency failed to inform the public that a widely prescribed heartburn drug was especially toxic to babies; that a diabetes medicine and a painkiller increased heart attack risks; and that antidepressants increased suicidal thoughts and behavior in children and teenagers.
READ MORE @ NY TIMES
Saturday, May 16, 2009
Cardiac Risks Hold Up Approval of Two Antipsychotics
FDA advisors remain skeptical about the safety of two antipsychotics for which regulatory approval is being sought and are especially troubled by potentially fatal cardiac risks.
Despite positive efficacy data from placebo-controlled trials, experts on a Food and Drug Administration (FDA) psychopharmacology advisory committee have reservations about potentially dangerous adverse effects of two antipsychotic medications under regulatory review for approval.
The FDA held meetings in April to seek the committee's advice on whether sertindole, a second-generation antipsychotic (SGA), should be approved for the treatment of schizophrenia and prevention of suicide in schizophrenia patients, and whether quetiapine XR extended-release tablets should be approved for treating major depressive disorder (MDD) as a monotherapy and as an adjunctive therapy to an antidepressant and for treating generalized anxiety disorder (GAD) as a monotherapy.
READ MORE @ PSYCHIATRIC TIMES
Despite positive efficacy data from placebo-controlled trials, experts on a Food and Drug Administration (FDA) psychopharmacology advisory committee have reservations about potentially dangerous adverse effects of two antipsychotic medications under regulatory review for approval.
The FDA held meetings in April to seek the committee's advice on whether sertindole, a second-generation antipsychotic (SGA), should be approved for the treatment of schizophrenia and prevention of suicide in schizophrenia patients, and whether quetiapine XR extended-release tablets should be approved for treating major depressive disorder (MDD) as a monotherapy and as an adjunctive therapy to an antidepressant and for treating generalized anxiety disorder (GAD) as a monotherapy.
READ MORE @ PSYCHIATRIC TIMES
Saturday, May 9, 2009
Is The FDA Easing Up? How one company turned a rejection into a thumbs up, and what it could mean for the drug industry as a whole.
After the Food and Drug Administration told Vanda Pharmaceuticals that the company's schizophrenia drug was "not approvable" last July, Wall Street marked the tiny biotech for dead.
The FDA asked for a new clinical trial; Vanda insisted it could change the agency's mind with its existing data. Its shares sank from $4 to 45 cents. A hedge fund, Tang Capital Partners, started a proxy fight to try and get Vanda to liquidate and distribute the proceeds to shareholders.
Then Wednesday night, the FDA announced it was approving the drug, Fanapt, based on data from 3,000 patients. Vanda shares exploded 700% to $8. That's the kind of jackpot that could start getting investors interested in gambling on tiny biotechs again.
But the Vanda story may signal something far more important for investors than just a reminder that biotech stocks can pop: an easier FDA. Both Wyeth ( WYE - news - people ), which is being bought by Pfizer ( PFE - news - people ), and Schering-Plough ( SGP - news - people ), which is being bought by Merck ( MRK - news - people ), were rebuffed last year by the FDA after submitting data for schizophrenia drugs.
READ MORE @ FORBES
The FDA asked for a new clinical trial; Vanda insisted it could change the agency's mind with its existing data. Its shares sank from $4 to 45 cents. A hedge fund, Tang Capital Partners, started a proxy fight to try and get Vanda to liquidate and distribute the proceeds to shareholders.
Then Wednesday night, the FDA announced it was approving the drug, Fanapt, based on data from 3,000 patients. Vanda shares exploded 700% to $8. That's the kind of jackpot that could start getting investors interested in gambling on tiny biotechs again.
But the Vanda story may signal something far more important for investors than just a reminder that biotech stocks can pop: an easier FDA. Both Wyeth ( WYE - news - people ), which is being bought by Pfizer ( PFE - news - people ), and Schering-Plough ( SGP - news - people ), which is being bought by Merck ( MRK - news - people ), were rebuffed last year by the FDA after submitting data for schizophrenia drugs.
READ MORE @ FORBES
Wednesday, April 29, 2009
Are we cherry picking participants for studies of antidepressants?
People with depression often excluded from clinical studies and tend not to fare as well as study participants
Findings from clinical studies used to gain Food and Drug Administration approval of common antidepressants are not applicable to most patients with depression, according to a report led by the University of Pittsburgh Graduate School of Public Health. Published in the May issue of the American Journal of Psychiatry, the study suggests only a small percentage of people with depression qualify for these studies, and those who do not qualify are often treated with the same medications but may suffer poorer clinical outcomes.
A part of the National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project – the largest study of the treatment of depression conducted in the United States – researchers compared symptoms and outcomes in depressed patients who met phase III study inclusion criteria to those who did not. Phase III studies for antidepressants determine the effectiveness of the drug in comparison to a placebo. The inclusion criteria for these studies are not standardized nor subject to federal guidelines, resulting in some variation from study to study in the profile of eligible patients. Typically excluded are patients with milder forms of depression, who might be more likely to respond to a placebo drug, and those who may have chronic depression or psychiatric and medical co-morbidities – additional illnesses or conditions.
After assessing 2,855 patients treated with citalopram, a commonly prescribed selective serotonin reuptake inhibitor for mood disorders, study authors concluded that fewer than one in four, or 22.2 percent, of the patients met the usual criteria for inclusion in phase III antidepressant trials.
"Only a small percentage of depressed patients in our study would have qualified for inclusion in phase III efficacy trials of depression drugs," said study lead author, Stephen Wisniewski, Ph.D., professor of epidemiology and co-director of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health. "This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems."
READ MORE @ EUREKALERT
Findings from clinical studies used to gain Food and Drug Administration approval of common antidepressants are not applicable to most patients with depression, according to a report led by the University of Pittsburgh Graduate School of Public Health. Published in the May issue of the American Journal of Psychiatry, the study suggests only a small percentage of people with depression qualify for these studies, and those who do not qualify are often treated with the same medications but may suffer poorer clinical outcomes.
A part of the National Institute of Mental Health-funded Sequenced Treatment Alternatives to Relieve Depression (STAR*D) project – the largest study of the treatment of depression conducted in the United States – researchers compared symptoms and outcomes in depressed patients who met phase III study inclusion criteria to those who did not. Phase III studies for antidepressants determine the effectiveness of the drug in comparison to a placebo. The inclusion criteria for these studies are not standardized nor subject to federal guidelines, resulting in some variation from study to study in the profile of eligible patients. Typically excluded are patients with milder forms of depression, who might be more likely to respond to a placebo drug, and those who may have chronic depression or psychiatric and medical co-morbidities – additional illnesses or conditions.
After assessing 2,855 patients treated with citalopram, a commonly prescribed selective serotonin reuptake inhibitor for mood disorders, study authors concluded that fewer than one in four, or 22.2 percent, of the patients met the usual criteria for inclusion in phase III antidepressant trials.
"Only a small percentage of depressed patients in our study would have qualified for inclusion in phase III efficacy trials of depression drugs," said study lead author, Stephen Wisniewski, Ph.D., professor of epidemiology and co-director of the Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health. "This raises major concerns about whether results from traditional phase III studies can be generalized to most people with depression, who also often suffer from anxiety, substance abuse and other medical and psychiatric problems."
READ MORE @ EUREKALERT
Monday, April 20, 2009
F.D.A. Rules on Drug Ads Sow Confusion as Applied to Web
WHEN the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, the warning was strong. The companies’ search advertisements — the short text ads that run beside Google results — had to start including risk information about each drug or else be rewritten or removed.
Just how the companies were supposed to comply was not so clear. In the 95 characters that Google allowed for search ads, there was no way to include all the required information, the companies argued.
Now, as the companies change their search ads to comply with the letters, industry executives say the solution is worse than the problem: their ads are even more confusing and misleading now, they say. And they worry that regulators will enforce standards that were created for magazines and television, rather than making new rules that acknowledge how Internet ads have evolved.
The letters were sent to almost all of the major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Merck and Eli Lilly. The letters said ads for widely prescribed drugs, including Celebrex, Propecia and Yaz, did not include the paragraphs of precautions the agency required.
READ MORE @ NY TIMES
Just how the companies were supposed to comply was not so clear. In the 95 characters that Google allowed for search ads, there was no way to include all the required information, the companies argued.
Now, as the companies change their search ads to comply with the letters, industry executives say the solution is worse than the problem: their ads are even more confusing and misleading now, they say. And they worry that regulators will enforce standards that were created for magazines and television, rather than making new rules that acknowledge how Internet ads have evolved.
The letters were sent to almost all of the major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Merck and Eli Lilly. The letters said ads for widely prescribed drugs, including Celebrex, Propecia and Yaz, did not include the paragraphs of precautions the agency required.
READ MORE @ NY TIMES
Sunday, April 12, 2009
Atypical antipsychotics: too hard a sell?
Use of drugs such as Abilify, Seroquel and Zyprexa for treatment-resistant depression is gaining ground. Some see an 'unmet need' for medication. Others worry about side effects.
About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
READ MORE @ LOS ANGELES TIMES
About a year ago, patients began trooping into the office of UCLA psychiatrist Andrew Leuchter, asking whether an antipsychotic drug called Abilify "might be right for them." Few appeared to be delusional, plagued by hallucinations or suffering fearsome mood swings. Mostly, they were depressed or anxious, and frustrated by the pace of their recovery.
Leuchter wondered what was up: Depressed patients didn't usually seek out drugs used to quell psychiatry's most disturbing symptoms.
What was up, he soon discovered, was spending on a new advertising campaign touting Abilify as an "add-on" treatment for depression. For the first time since the arrival of a new generation of antipsychotic medications -- six drugs called the "atypicals" because they work differently from the earlier generation of antipsychotic drugs -- the makers of one, Abilify, had been granted the legal right to market to a vast new population of patients beyond those with schizophrenia or bipolar disorder.
This week, a Food and Drug Administration advisory panel recommended that the agency should grant the makers of a second atypical antipsychotic drug -- Seroquel XR -- similar latitude. The drug giant AstraZeneca wants permission to market the drug as a treatment for depression or anxiety that has not yielded to antidepressants alone.
READ MORE @ LOS ANGELES TIMES
Monday, March 23, 2009
FDA approves antidepressant Lexapro for adolescents
The decision comes after Justice Department allegations that the drug's maker, Forest Laboratories, had improperly induced pediatricians to prescribe it and a similar pill, Celexa.
Just weeks after prosecutors accused Forest Laboratories Inc. of illegally marketing its antidepressants Celexa and Lexapro to children and paying pediatricians kickbacks, U.S. health regulators Friday approved Lexapro for depression in kids.
Forest said Lexapro was approved by the U.S. Food and Drug Administration to treat major depressive disorder in adolescents aged 12 to 17 and as a maintenance therapy to control symptoms. It is already approved for adults, and registers annual sales of more than $2 billion.
The FDA on Friday approved Lexapro's use for adolescents based on favorable results in two clinical trials -- one involving adolescents taking Lexapro and another involving children and adolescents taking the chemically similar Celexa, Forest said.
READ MORE @ LOS ANGELES TIMES
Just weeks after prosecutors accused Forest Laboratories Inc. of illegally marketing its antidepressants Celexa and Lexapro to children and paying pediatricians kickbacks, U.S. health regulators Friday approved Lexapro for depression in kids.
Forest said Lexapro was approved by the U.S. Food and Drug Administration to treat major depressive disorder in adolescents aged 12 to 17 and as a maintenance therapy to control symptoms. It is already approved for adults, and registers annual sales of more than $2 billion.
The FDA on Friday approved Lexapro's use for adolescents based on favorable results in two clinical trials -- one involving adolescents taking Lexapro and another involving children and adolescents taking the chemically similar Celexa, Forest said.
READ MORE @ LOS ANGELES TIMES
Monday, February 9, 2009
AP IMPACT: Drugmakers' push boosts 'murky' ailment
Two drugmakers spent hundreds of millions of dollars last year to raise awareness of a murky illness, helping boost sales of pills recently approved as treatments and drowning out unresolved questions — including whether it's a real disease at all.
Key components of the industry-funded buzz over the pain-and-fatigue ailment fibromyalgia are grants — more than $6 million donated by drugmakers Eli Lilly and Pfizer in the first three quarters of 2008 — to nonprofit groups for medical conferences and educational campaigns, an Associated Press analysis found.
That's more than they gave for more accepted ailments such as diabetes and Alzheimer's. Among grants tied to specific diseases, fibromyalgia ranked third for each company, behind only cancer and AIDS for Pfizer and cancer and depression for Lilly.
Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments.
READ MORE @ ASSOCIATED PRESS
Key components of the industry-funded buzz over the pain-and-fatigue ailment fibromyalgia are grants — more than $6 million donated by drugmakers Eli Lilly and Pfizer in the first three quarters of 2008 — to nonprofit groups for medical conferences and educational campaigns, an Associated Press analysis found.
That's more than they gave for more accepted ailments such as diabetes and Alzheimer's. Among grants tied to specific diseases, fibromyalgia ranked third for each company, behind only cancer and AIDS for Pfizer and cancer and depression for Lilly.
Fibromyalgia draws skepticism for several reasons. The cause is unknown. There are no tests to confirm a diagnosis. Many patients also fit the criteria for chronic fatigue syndrome and other pain ailments.
READ MORE @ ASSOCIATED PRESS
Tuesday, January 13, 2009
UPDATE 3-US lets drugmakers advise doctors on unapproved uses
U.S. health officials finalized guidelines that allow pharmaceutical companies to tell doctors about unapproved uses of their medicines, a practice opposed by critics of industry marketing.
The Food and Drug Administration (FDA) guidelines allow manufacturers such as Pfizer Inc (PFE.N) and Merck & Co (MRK.N) to distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.
The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.
By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for any use they see fit, a practice known as "off-label" use.
Distribution of medical literature suggesting a drug may have merit for an unapproved use is a marketing area that has been in dispute for years.
READ MORE @ REUTERS
The Food and Drug Administration (FDA) guidelines allow manufacturers such as Pfizer Inc (PFE.N) and Merck & Co (MRK.N) to distribute copies of medical journal articles that describe unapproved uses. The action could help companies expand the markets for medicines and medical devices.
The move, announced a week before Republican President George W. Bush leaves office, puts in place a policy that drew objections from congressional Democrats and drug-industry critics when it was proposed last year. Opponents say it will allow promotion of uses without adequate testing.
By law, manufacturers are prohibited from marketing their medicines for uses not approved by the FDA. But doctors can prescribe drugs for any use they see fit, a practice known as "off-label" use.
Distribution of medical literature suggesting a drug may have merit for an unapproved use is a marketing area that has been in dispute for years.
READ MORE @ REUTERS
Sunday, December 21, 2008
FDA Faults Drug Information for Consumers
The printed consumer information that accompanies new prescription drugs is often difficult to read or understand, the U.S. Food and Drug Administration said Tuesday.
In a new report, the FDA said the "consumer medication information" -- intended to spell out the proper use and risks of drugs -- failed to meet a Congressionally mandated goal that 95 percent of all new prescriptions be accompanied by useful guidance.
"The study reveals that consumers are not consistently getting the information they need to promote the safe and effective use of prescription medicines," Dr. Paul Seligman, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research, said during a Tuesday teleconference.
READ MORE @ WASHINGTON POST
In a new report, the FDA said the "consumer medication information" -- intended to spell out the proper use and risks of drugs -- failed to meet a Congressionally mandated goal that 95 percent of all new prescriptions be accompanied by useful guidance.
"The study reveals that consumers are not consistently getting the information they need to promote the safe and effective use of prescription medicines," Dr. Paul Seligman, associate director of safety policy and communication at the FDA's Center for Drug Evaluation and Research, said during a Tuesday teleconference.
READ MORE @ WASHINGTON POST
Subscribe to:
Posts (Atom)
