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
Showing posts with label Off-Label Drug Use. Show all posts
Showing posts with label Off-Label Drug Use. Show all posts
Wednesday, October 28, 2009
Sunday, October 4, 2009
Antidepressant and placebo are equally effective in child pain relief
When used "off-label," the antidepressant amitriptyline works just as well as placebo in treating pain-predominant gastrointestinal disorders in children, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute. To view this article's video abstract, go to the AGA's YouTube Channel at www.youtube.com/AmerGastroAssn.
"Many pharmaceutical products are prescribed for off-label use in children due to the lack of clinical trials testing the efficacy of the drugs in children and adolescents. Therefore, the pediatric gastroenterologist frequently has to make treatment decisions without the evidence of how drugs work in children," said Miguel Saps, MD, of Children's Memorial Hospital and lead author of the study. "The high placebo effect we identified in this study suggests that further studies of the use of certain antidepressants in children with functional bowel disorders are needed. While several trials have demonstrated a beneficial effect of antidepressants, including amitriptyline, for the treatment of irritable bowel syndrome (IBS) in adults, more research is needed to determine how effective this drug is, if at all, in children."
READ MORE @ EUREKALERT
"Many pharmaceutical products are prescribed for off-label use in children due to the lack of clinical trials testing the efficacy of the drugs in children and adolescents. Therefore, the pediatric gastroenterologist frequently has to make treatment decisions without the evidence of how drugs work in children," said Miguel Saps, MD, of Children's Memorial Hospital and lead author of the study. "The high placebo effect we identified in this study suggests that further studies of the use of certain antidepressants in children with functional bowel disorders are needed. While several trials have demonstrated a beneficial effect of antidepressants, including amitriptyline, for the treatment of irritable bowel syndrome (IBS) in adults, more research is needed to determine how effective this drug is, if at all, in children."
READ MORE @ EUREKALERT
Saturday, October 3, 2009
Oops, They Did It Again - What Integrity Means to Pfizer
The satire was biting:
"Thanks for making time to see me today," posted a rep on cafepharma about a fictitious sales meeting with a psychiatrist. "Now, I know that you used Neurontin in the past for every condition under the sun. Pfizer knows very well that you guys were and still continue to be the largest writers of off-label Lyrica and so, in the spirit of Bextra [withdrawn in 2004] will you please write Lyrica as much as possible? Remember Dr, this is Pfizer. The company that never met an off-label sale that it wouldn't cover-up."
Don't forget, writes the next poster on the pharma site, the psychiatrist answers, "Great! and I also heard that it is about to be approved on state Medicaid and I can write it for anything. Is this true?" to which the rep assents in defiance of, "that nice little 2004 CIA agreement."
Pfizer's nice little 2004 "CIA" or Corporate Integrity Agreement in which a company promises to sin no more to which the poster refers was for fraudulent marketing of seizure drug Neurontin. It was preceded by a CIA for fraud related to Pfizer's cholesterol drug, Lipitor, in 2002.
And this month it's followed by a CIA for mis-marketing pain drug Bextra, antipsychotic Geodon, seizure drug Lyrica and antibiotic Zyvox.
Pfizer's $2.3 billion health care fraud settlement with the government announced this month by the US Department of Justice adds some firsts to the world's biggest pharmaceutical company.
It is the largest health care fraud settlement in the history of the Department of Justice "to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products,"--and the largest criminal fine ever imposed in the United States. It covers Pfizer's kickbacks to health care providers and false claims submitted to government health care programs, also known as our tax dollars, in violation of the Food, Drug and Cosmetic Act. Forty-three states will share in the "give backs."
But it is not exhaustive.
READ MORE @ COUNTERPUNCH
"Thanks for making time to see me today," posted a rep on cafepharma about a fictitious sales meeting with a psychiatrist. "Now, I know that you used Neurontin in the past for every condition under the sun. Pfizer knows very well that you guys were and still continue to be the largest writers of off-label Lyrica and so, in the spirit of Bextra [withdrawn in 2004] will you please write Lyrica as much as possible? Remember Dr, this is Pfizer. The company that never met an off-label sale that it wouldn't cover-up."
Don't forget, writes the next poster on the pharma site, the psychiatrist answers, "Great! and I also heard that it is about to be approved on state Medicaid and I can write it for anything. Is this true?" to which the rep assents in defiance of, "that nice little 2004 CIA agreement."
Pfizer's nice little 2004 "CIA" or Corporate Integrity Agreement in which a company promises to sin no more to which the poster refers was for fraudulent marketing of seizure drug Neurontin. It was preceded by a CIA for fraud related to Pfizer's cholesterol drug, Lipitor, in 2002.
And this month it's followed by a CIA for mis-marketing pain drug Bextra, antipsychotic Geodon, seizure drug Lyrica and antibiotic Zyvox.
Pfizer's $2.3 billion health care fraud settlement with the government announced this month by the US Department of Justice adds some firsts to the world's biggest pharmaceutical company.
It is the largest health care fraud settlement in the history of the Department of Justice "to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products,"--and the largest criminal fine ever imposed in the United States. It covers Pfizer's kickbacks to health care providers and false claims submitted to government health care programs, also known as our tax dollars, in violation of the Food, Drug and Cosmetic Act. Forty-three states will share in the "give backs."
But it is not exhaustive.
READ MORE @ COUNTERPUNCH
Monday, September 21, 2009
Dueling Intimidation Allegations Filed in Neurontin Litigation
The continuing litigation about whether Pfizer’s anti-seizure medication Neurontin is linked to suicidal behavior in some patients has been marred by allegations filed by attorneys on both sides accusing the other of using intimidation and strong-arm tactics.
Neurontin, known chemically as gabapentin, is an anti-epileptic medication (also called an anticonvulsant) taken by patients to reduce or eliminate seizures in adults and children as young as 12. The drug has been associated with serious side effects, most notably suicide.
Pfizer
Attorneys representing victims of Neurontin recently accused Pfizer’s counsel of trying to intimidate a potential key witness in the case. Pfizer’s attorneys then returned fire with a similar complaint against David Egilman, an expert witness for the plaintiffs.
READ MORE AT ATTORNEYATLAW.COM
Neurontin, known chemically as gabapentin, is an anti-epileptic medication (also called an anticonvulsant) taken by patients to reduce or eliminate seizures in adults and children as young as 12. The drug has been associated with serious side effects, most notably suicide.
Pfizer
Attorneys representing victims of Neurontin recently accused Pfizer’s counsel of trying to intimidate a potential key witness in the case. Pfizer’s attorneys then returned fire with a similar complaint against David Egilman, an expert witness for the plaintiffs.
READ MORE AT ATTORNEYATLAW.COM
Thursday, September 3, 2009
Pfizer Pays $2.3 Billion to Settle Marketing Case
The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.
It was the largest health care fraud settlement and the largest criminal fine of any kind ever.
Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.
“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.
Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.
READ MORE @ NY TIMES
It was the largest health care fraud settlement and the largest criminal fine of any kind ever.
Although the investigation began and largely ended during the Bush administration, top Obama administration officials held a news conference on Wednesday to celebrate the settlement, thank each other for resolving it and promise more crackdowns on health fraud.
“It’s another step in the administration’s ongoing effort to prosecute any individual or organization that tries to rip off health care consumers and the federal government,” said Kathleen Sebelius, secretary of health and human services.
Republicans and Democrats on Capitol Hill have accused the Obama administration of failing to crack down adequately on health care fraud, arguing that huge savings in government health programs could be found with better enforcement. The settlement had been expected. Pfizer, which is acquiring a rival, Wyeth, reported in January that it had taken a $2.3 billion charge to resolve claims involving Bextra and other drugs. It was Pfizer’s fourth settlement over illegal marketing activities since 2002.
READ MORE @ NY TIMES
Wednesday, August 12, 2009
Anti-psychotic drugs could help fight cancer
The observation that people taking medication for schizophrenia have lower cancer rates than other people has prompted new research revealing that anti-psychotic drugs could help treat some major cancers.
A preliminary finding in the current online issue of the International Journal of Cancer reports that the anti-psychotic drug, pimozide, kills lung, breast and brain cancer cells in in-vitro laboratory experiments.
Several epidemiological studies have noted the low rate of cancer among schizophrenic patients. These studies found, for example, that these patients have lower rates of lung cancer than other people, even though they are more likely to smoke.
Genetic factors and the possibility of reduced cancer detection in patients have been considered and over the past decade anti-psychotic drugs have been suggested as possible mediators of this effect.
In the new study, pimozide was the most lethal of six anti-psychotic drugs tested by a team from UNSW and the University of Queensland. Rapidly-dividing cancer cells require cholesterol and lipids to grow and the researchers suspect that pimozide kills cancer cells by blocking the synthesis or movement of cholesterol and lipid in cancer cells.
Analysis of gene expression in test cancer cells showed that genes involved in the synthesis and uptake of cholesterol and lipids were boosted when pimozide was introduced.
READ MORE @ EUREKALERT
A preliminary finding in the current online issue of the International Journal of Cancer reports that the anti-psychotic drug, pimozide, kills lung, breast and brain cancer cells in in-vitro laboratory experiments.
Several epidemiological studies have noted the low rate of cancer among schizophrenic patients. These studies found, for example, that these patients have lower rates of lung cancer than other people, even though they are more likely to smoke.
Genetic factors and the possibility of reduced cancer detection in patients have been considered and over the past decade anti-psychotic drugs have been suggested as possible mediators of this effect.
In the new study, pimozide was the most lethal of six anti-psychotic drugs tested by a team from UNSW and the University of Queensland. Rapidly-dividing cancer cells require cholesterol and lipids to grow and the researchers suspect that pimozide kills cancer cells by blocking the synthesis or movement of cholesterol and lipid in cancer cells.
Analysis of gene expression in test cancer cells showed that genes involved in the synthesis and uptake of cholesterol and lipids were boosted when pimozide was introduced.
READ MORE @ EUREKALERT
Monday, August 3, 2009
Antidepressant Use in U.S. Has Almost Doubled Study also finds increases in use of other psychotropic medications
Antidepressant use among U.S. residents almost doubled between 1996 and 2005, along with a concurrent rise in the use of other psychotropic medications, a new report shows.
The increase seemed to span virtually all demographic groups.
"Over 10 percent of people over the age of 6 were receiving anti-depression medication. That strikes me as significant," said study author Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University/New York State Psychiatric Institute in New York City.
According to background information in the study, antidepressants are now the most widely prescribed class of drugs in the United States. The expansion in use dates back to the 1980s, with the introduction of the antidepressant Prozac (fluoxetine).
The study found that 5.84 percent of U.S. residents aged 6 and over were using antidepressants in 1996, compared with 10.12 percent in 2005. That's 13.3 million people, up to 27 million people.
"This is a 20-year trend and it's very powerful," remarked Dr. Eric Caine, chair of the department of psychiatry and co-director of the Center for the Study of Prevention of Suicide at the University of Rochester Medical Center.
This happened despite a "black box" warning mandated for many antidepressant medications by the U.S. Food and Drug Administration in 2004, the study authors noted.
READ MORE @ U.S. NEWS & WORLD REPORT
The increase seemed to span virtually all demographic groups.
"Over 10 percent of people over the age of 6 were receiving anti-depression medication. That strikes me as significant," said study author Dr. Mark Olfson, a professor of clinical psychiatry at Columbia University/New York State Psychiatric Institute in New York City.
According to background information in the study, antidepressants are now the most widely prescribed class of drugs in the United States. The expansion in use dates back to the 1980s, with the introduction of the antidepressant Prozac (fluoxetine).
The study found that 5.84 percent of U.S. residents aged 6 and over were using antidepressants in 1996, compared with 10.12 percent in 2005. That's 13.3 million people, up to 27 million people.
"This is a 20-year trend and it's very powerful," remarked Dr. Eric Caine, chair of the department of psychiatry and co-director of the Center for the Study of Prevention of Suicide at the University of Rochester Medical Center.
This happened despite a "black box" warning mandated for many antidepressant medications by the U.S. Food and Drug Administration in 2004, the study authors noted.
READ MORE @ U.S. NEWS & WORLD REPORT
Sunday, June 14, 2009
FDA Throws Lifeline to Antipsychotic Pushers
On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics "won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients."
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
READ MORE @ COUNTERPUNCH
"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.
"Rather than focus on protecting children's safety, FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.
A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.
READ MORE @ COUNTERPUNCH
Monday, May 11, 2009
Antidepressants: The right people aren't always getting them
The medications are widely used to treat complaints such as loneliness or low energy. Meanwhile, studies say many with depression go untreated.
It was just over 20 years ago that the antidepressant Prozac was first approved by the U.S. Food and Drug Administration. The medication was touted as nothing short of a miracle: Not only was it was highly effective in treating depression, it also caused very few side effects.
The drug's popularity grew rapidly, and pharmaceutical companies got busy developing a variety of other, chemically similar antidepressants, collectively referred to as selective serotonin reuptake inhibitors (or SSRIs). There are at least half a dozen SSRIs on the market, including Lexapro, Paxil, Zoloft, Celexa and Luvox.
Since the introduction of these drugs, the number of Americans being treated for depression has increased dramatically; the Centers for Disease Control and Prevention says antidepressants are the most commonly prescribed medication in the country. But it's not always the right people taking them. Some who probably have very little to gain from their use are on SSRIs; others who stand to benefit are not.
READ MORE @ LOS ANGELES TIMES
It was just over 20 years ago that the antidepressant Prozac was first approved by the U.S. Food and Drug Administration. The medication was touted as nothing short of a miracle: Not only was it was highly effective in treating depression, it also caused very few side effects.
The drug's popularity grew rapidly, and pharmaceutical companies got busy developing a variety of other, chemically similar antidepressants, collectively referred to as selective serotonin reuptake inhibitors (or SSRIs). There are at least half a dozen SSRIs on the market, including Lexapro, Paxil, Zoloft, Celexa and Luvox.
Since the introduction of these drugs, the number of Americans being treated for depression has increased dramatically; the Centers for Disease Control and Prevention says antidepressants are the most commonly prescribed medication in the country. But it's not always the right people taking them. Some who probably have very little to gain from their use are on SSRIs; others who stand to benefit are not.
READ MORE @ LOS ANGELES TIMES
Thursday, January 15, 2009
Lilly to Pay Biggest Fine Ever to End Zyprexa Probe (Update7)
Eli Lilly & Co. will plead guilty to a charge of promoting its antipsychotic drug Zyprexa for unapproved uses and pay $1.42 billion, including the largest criminal fine ever imposed by the U.S. on an individual company.
The company admitted its marketing of Zyprexa was illegal in a civil and criminal settlement announced jointly today in a statement by Acting U.S. Attorney Laurie Magid and Attorney General Michael Mukasey. Lilly will also submit to U.S. monitoring against future lawbreaking.
Lilly resolved federal and state probes into how it marketed the drug and will make its guilty plea in U.S. District Court in Philadelphia in the next few weeks, the Indianapolis- based drugmaker said in a statement. Lilly said it promoted Zyprexa in elderly people to treat dementia, a use not approved by the Food and Drug Administration, between September 1999 and March 2001, a criminal violation of the Food, Drug and Cosmetic Act.
“Eli Lilly completely ignored the law” and made “hundred of millions of dollars” from its illegal promotion of Zyprexa, Magid said at a press conference in Philadelphia today. “We’re holding a company responsible for putting thousands and thousands of patients at risk.”
READ MORE @ BLOOMBERG
The company admitted its marketing of Zyprexa was illegal in a civil and criminal settlement announced jointly today in a statement by Acting U.S. Attorney Laurie Magid and Attorney General Michael Mukasey. Lilly will also submit to U.S. monitoring against future lawbreaking.
Lilly resolved federal and state probes into how it marketed the drug and will make its guilty plea in U.S. District Court in Philadelphia in the next few weeks, the Indianapolis- based drugmaker said in a statement. Lilly said it promoted Zyprexa in elderly people to treat dementia, a use not approved by the Food and Drug Administration, between September 1999 and March 2001, a criminal violation of the Food, Drug and Cosmetic Act.
“Eli Lilly completely ignored the law” and made “hundred of millions of dollars” from its illegal promotion of Zyprexa, Magid said at a press conference in Philadelphia today. “We’re holding a company responsible for putting thousands and thousands of patients at risk.”
READ MORE @ BLOOMBERG
Tuesday, November 11, 2008
Antipsychotics Aren't Anti-Depressants
I saw the Abilify for depression TV ad again over the weekend and I continue to be concerned about how Bristol-Myers Squibb is very craftily making the drug, an atypical antipsychotic, sound as if it's an anti-depressant. Nowhere in the TV is it mentioned that the drug is an antipsychotic, at least not in what I've caught on-air.
I've written about the ad previously here and have also written about how the drug's clinical trials for depression show a greater chance for a patient to experience akathisia than to have his or her depression improved.
READ MORE @ FURIOUS SEASONS
I've written about the ad previously here and have also written about how the drug's clinical trials for depression show a greater chance for a patient to experience akathisia than to have his or her depression improved.
READ MORE @ FURIOUS SEASONS
Friday, October 24, 2008
Lilly Will Take $1.42 Billion Charge in Zyprexa Probe (Update1)
Eli Lilly & Co. said it is having ``advanced discussions'' to settle investigations by U.S. and state authorities over marketing the antipsychotic Zyprexa and will take a $1.42 billion charge in the third quarter.
The charge will amount to $1.29 a share and reflects Lilly's ``currently estimable exposure'' to investigations into whether it promoted Zyprexa for unapproved uses, the Indianapolis-based company said today in a statement.
Investigations by the U.S. Attorney's Office for the Eastern District of Pennsylvania and more than 30 state Medicaid fraud units focus on Lilly's marketing to U.S. doctors and the drugmaker's payments to consulting physicians and other advisers. The announcement follows Lilly's Oct. 7 settlement of consumer fraud investigations by 32 states and the District of Columbia into the company's marketing of Zyprexa, its top-selling drug.
``The government's investigation of Zyprexa has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,'' said Robert A. Armitage, Lilly's general counsel, in the statement. The company is cooperating with the investigations, Lilly said.
READ MORE @ BLOOMBERG
The charge will amount to $1.29 a share and reflects Lilly's ``currently estimable exposure'' to investigations into whether it promoted Zyprexa for unapproved uses, the Indianapolis-based company said today in a statement.
Investigations by the U.S. Attorney's Office for the Eastern District of Pennsylvania and more than 30 state Medicaid fraud units focus on Lilly's marketing to U.S. doctors and the drugmaker's payments to consulting physicians and other advisers. The announcement follows Lilly's Oct. 7 settlement of consumer fraud investigations by 32 states and the District of Columbia into the company's marketing of Zyprexa, its top-selling drug.
``The government's investigation of Zyprexa has been ongoing for five years and we now have a heightened sense of responsibility to all our stakeholders to intensify efforts to resolve these issues,'' said Robert A. Armitage, Lilly's general counsel, in the statement. The company is cooperating with the investigations, Lilly said.
READ MORE @ BLOOMBERG
Monday, September 8, 2008
Judge OKs Zyprexa Class Action, Unseals Documents
A federal judge has granted class action status to a Zyprexa lawsuit that claimed Eli Lilly hid the drug’s serious side effects. The decision by Judge Jack B. Weinstein of Federal District Court in Brooklyn also unseals confidential documents relating to the antipsychotic medication. Eli Lily
The Zyprexa lawsuit in question was brought by insurance companies, pension funds and unions that want repaid for the money the they spent on the drug. The plaintiffs contend that Eli Lilly knew that Zyprexa had caused excessive weight gain and diabetes, and that the company marketed it for unapproved uses. In July, Judge Weinstein urged Lilly to settle, but the case will now proceed to a jury trial.
The judge also unsealed hundreds of pages of confidential documents that were produced by Eli Lilly in relation to a lawsuit filed by patients. They were placed under a protective court order soon after that suit was filed in 2004.
READ MORE @ NEWS INFERNO
The Zyprexa lawsuit in question was brought by insurance companies, pension funds and unions that want repaid for the money the they spent on the drug. The plaintiffs contend that Eli Lilly knew that Zyprexa had caused excessive weight gain and diabetes, and that the company marketed it for unapproved uses. In July, Judge Weinstein urged Lilly to settle, but the case will now proceed to a jury trial.
The judge also unsealed hundreds of pages of confidential documents that were produced by Eli Lilly in relation to a lawsuit filed by patients. They were placed under a protective court order soon after that suit was filed in 2004.
READ MORE @ NEWS INFERNO
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