Beware of what is prescribed to you, not all medication is created equal and especially medication that you give to your children. Heavily regulated industry and we are still dealing with the consequence of misrepresentation and misuse.
As stated in MedPageToday.com:
GlaxoSmithKline has agreed to plead guilty and pay $3 billion in civil and criminal penalties in a deal with federal prosecutors over its marketing of paroxetine HCl (Paxil), bupropion (Wellbutrin), and other drugs, and for failing to report safety problems with rosiglitazone (Avandia), the government announced Monday.One of the medications that was misrepresented is Paxil. Paxil is a widely used in the outpatient treatment substance that controls anxiety and depression. By taking the medication a child not only did not receive any treatment, but was also subjected to "risk of suicidal thinking and behavior":
I am sure that this is a sad reality for a lot of patients and providers that have prescribed and most importantly took the medication and suffered from side effects.Paxil
GSK acknowledged that its labeling for paroxetine was false and misleading because the company allegedly promoted Paxil for treating depression in patients under 18, even though the FDA never approved it for use in children and adolescents.
GSK allegedly participated in the publishing of medical journal articles that stated paroxetine was effective in patients under 18, when, in fact, the data showed that the opposite was true. At the same time, the company withheld study data in from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18, according to a press release from the Justice Department.
The company also "sponsored dinner programs, lunch programs, spa programs, and similar activities to promote the use of Paxil in children and adolescents," the Justice Department said.
Paroxetine and other antidepressants have carried black box warnings since 2004, stating that antidepressants may increase the risk of suicidal thinking and behavior in patients under age 18.
...
Original article appeared in MedPageToday.com. Full body of the article along with the link to the source is listed below:
GSK to Pay $3B for Sales, Safety Violations
WASHINGTON -- GlaxoSmithKline has agreed to plead guilty and pay $3 billion in civil and criminal penalties in a deal with federal prosecutors over its marketing of paroxetine HCl (Paxil), bupropion (Wellbutrin), and other drugs, and for failing to report safety problems with rosiglitazone (Avandia), the government announced Monday.
The initial terms of the agreement were first announced in 2011. The government said this was the largest health fraud settlement in U.S. history.
"Today's historic settlement is a major milestone in our efforts to stamp out health care fraud," Bill Corr, deputy secretary of the Department of Health and Human Services (HHS), said in a press release. "For a long time, our healthcare system had been a target for cheaters who thought they could make an easy profit at the expense of public safety, taxpayers, and the millions of Americans who depend on programs like Medicare and Medicaid. But thanks to strong enforcement actions like those we have announced today, that equation is rapidly changing."
Paxil
GSK acknowledged that its labeling for paroxetine was false and misleading because the company allegedly promoted Paxil for treating depression in patients under 18, even though the FDA never approved it for use in children and adolescents.
GSK allegedly participated in the publishing of medical journal articles that stated paroxetine was effective in patients under 18, when, in fact, the data showed that the opposite was true. At the same time, the company withheld study data in from two other studies in which Paxil also failed to demonstrate efficacy in treating depression in patients under 18, according to a press release from the Justice Department.
The company also "sponsored dinner programs, lunch programs, spa programs, and similar activities to promote the use of Paxil in children and adolescents," the Justice Department said.
Paroxetine and other antidepressants have carried black box warnings since 2004, stating that antidepressants may increase the risk of suicidal thinking and behavior in patients under age 18.
Wellbutrin
The government also alleged that from 1999 to 2003, GSK promoted bupropion -- a drug approved only for major depressive disorder -- for a slew of conditions, including weight loss, the treatment of sexual dysfunction, substance addictions, and attention deficit-hyperactivity disorder.
GSK paid millions to doctors to promote the drug off-label during meetings sometimes held at swanky resorts, the government said. The company relied on pharmaceutical sales reps, "sham advisory boards," and continuing medical education programs that appeared independent but were not.
Avandia
GSK has agreed to pay $243 million for its unlawful conduct concerning the diabetes drug rosiglitazone, in part for failing to give the FDA required post-marketing safety data on the drug. According to the government, the company kept secret data on raised cardiovascular effects.
Since 2007, rosiglitazone has carried a black box warning alerting patients and physicians to the drug's potential increased risk for congestive heart failure and heart attack.
To settle all the criminal charges involving the three drugs -- Paxil, Wellbutrin, and Avandia -- GSK agreed to pay $1 billion.
Civil Settlement
In the civil settlement portion of the resolution announced Monday, GSK agreed to pay $2 billion to settle civil claims that the company promoted Paxil, Wellbutrin, asthma drug combination fluticasone/salmeterol (Advair), anti-epileptic medication lamotrigine (Lamictal), and anti-nausea medicine ondansetron (Zofran) for off-label uses, and that it paid kickbacks to doctors to prescribe those drugs along with migraine drug sumatriptan (Imitrex), irritable bowel syndrome medication alosetron (Lotronex), asthma drug fluticasone (Flovent), and herpes medication valacyclovir (Valtrex).
The civil settlement also levies millions in fines against GSK to settle false claims allegations related to use of Avandia.
In addition, the settlement also requires GSK to pay $300 million to resolve allegations that the company reported false drug prices under Medicaid, making it appear that its drugs were cheaper than what they actually were. As a result, GSK underpaid rebates due to Medicaid and overcharged the government, according to the Justice Department.
Corporate Integrity Agreement
In addition to the criminal and civil resolutions, GSK will participate in a 5-year Corporate Integrity Agreement with the HHS Office of Inspector General that will require the company to make "major changes to the way it does business, including changing the way its sales force is compensated to remove compensation based on sales goals for territories, one of the driving forces behind much of the conduct at issue in this matter," according to the press release.
"For example, company executives may have to forfeit annual bonuses if they or their subordinates engage in significant misconduct, and sales agents are now being paid based on quality of service rather than sales targets," HHS Inspector General Daniel Levinson said in a statement.
GSK CEO Andrew Witty said while charges originated in a "different era for the company," that they "cannot and will not be ignored."
"On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made," he said in a statement.
He said the company has "fundamentally changed" its marketing and selling procedures, including firing employees and changing how sales representatives are paid.
No comments:
Post a Comment