Federal prosecutors hit Pfizer Inc. with a record-breaking $2.3 billion in fines Wednesday and called the world’s largest drug maker a repeating corporate cheat for illegal drug promotions that plied doctors with free golf, massages, and resort junkets.
Announcing the penalty as a warning to all drug manufacturers, Justice Department officials said the overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules, and the $1.2 billion criminal fine is the largest ever in any U.S. criminal case. The total includes $1 billion in civil penalties and a $100 million criminal forfeiture.
Authorities called Pfizer a repeat offender, noting it is the company’s fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.
As part of its illegal marketing, Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks, prosecutors said.
“They were entertained with golf, massages, and other activities,” said Mike Loucks, the U.S. attorney in Massachusetts.
Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs.
To prevent backsliding this time, Pfizer’s conduct will be specially monitored by the Health and Human Service Department inspector general for five years.
In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.
Associate Attorney General Thomas Perrelli said the settlement illustrates ways the Justice Department “can help the American public at a time when budgets are tight and health care costs are rising.”
Perrelli announced the settlement terms at a news conference with federal prosecutors and FBI, and Health and Human Services Department officials.
The settlement ends an investigation that also resulted in guilty pleas from two former Pfizer sales managers.
Officials said the U.S. industry has paid out more than $11 billion in such settlements over the past decade, but one consumer advocate voiced hope that Wednesday’s penalty was so big it would curb the abuses.
“There’s so much money in selling pills, that there’s a tremendous temptation to cheat,” said Bill Vaughan, an analyst at Consumers Union, the nonprofit publisher of Consumer Reports.
“There’s a kind of mentality in this sector that (settlements) are the cost of doing business and we can cheat. This penalty is so huge I think consumers can have some hope that maybe these guys will tighten up and run a better ship.”
The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different from those the drugs had been approved for by federal regulators. Authorities said Pfizer’s salesmen and women created phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.
Use of drugs for so-called “off-label” medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. They said the junkets and other company-paid perks were designed to promote Bextra and other drugs, to doctors for unapproved uses and dosages, backed by false and misleading claims about safety and effectiveness.
Bextra, for instance, was approved for arthritis, but Pfizer promoted it for acute pain and surgical pain, and in dosages above the approved maximum. In 2005, Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market amid mounting evidence it raised the risk of heart attack, stroke and death.
A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra.
The $1 billion in civil penalties was related to Bextra and a number of other medicines.
A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state’s Medicaid program.
Pfizer’s top lawyer, Amy Schulman, said the settlements “bring final closure to significant legal matters and help to enhance our focus on what we do best — discovering, developing and delivering innovative medicines.”
In her statement, Schulman said: “We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures.”
In financial filings in January, the company had indicated that it would pay $2.3 billion over the allegations.
The civil settlement announced Wednesday covered Pfizer’s promotions of Bextra, blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. The agreement with the Justice Department resolves the investigation into promotion of all those drugs, Pfizer said.
The government said Pfizer also paid kickbacks to market a host of big-name drugs: Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec.
The allegations came to light thanks largely to five Pfizer employees and one Pennsylvania doctor, who will now share $102 million of the settlement money.
FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to “speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims.”
Florida Home owners have filed another Chinese Drywall Lawsuit. This is the latest of four lawsuits filed so far and allege that tens of thousands of florida homes could be built with the defective Drywall from China.
Several homeowners have complained of “rotten egg” smells coming from the drywall. Drywall is usually manufactured in the United States but due to recent shortages, many contractors were forced to use the Chinese made Drywall.
The company behind the supply of the defective products is Knauf Plasterboard Tianjin Co. Ltd. of China, a subsidiary of German-based manufacturer Knauf Group.
The health department said that most of the homes being investigated were built after 2004, but one home that is the subject of complaints was built in 2001.
The U.S. Consumer Product Safety Commission said last week it was investigating complaints that Chinese-made drywall was emitting odors and causing appliance problems in homes.
Several people have come forward and many more are expected to as Florida homeowners find out that issues are related to the Chinese Drywall.
The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died.
All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.
The FDA is reviewing this latest information. The agency will take appropriate steps to:
ensure that the risks of Raptiva do not outweigh its benefits;
that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
that health care professionals carefully monitor patients for the possible development of PML.
The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.
Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system.
These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient’s susceptibility to infections.
Since the approval of Raptiva (efalizumab) in October 2003, the FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis.
Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years. None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.
PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.
Raptiva works by affecting T-cells in the immune system. The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections.
Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003. There were no cases of PML seen in the clinical trials that supported the approval of Raptiva. At the time of approval, a total of 2,764 patients had been treated with Raptiva. Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more.
In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.
The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML.
Healthcare providers should, in the interim, be aware of the following information and advice:
Raptiva increases the risk of PML. Longer, continuous use may further increase this risk.
Inform patients using Raptiva of the potential risk of developing PML.
There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.
Monitor patients being treated with Raptiva for the onset of neurologic symptoms. Discontinue Raptiva if PML is suspected.
Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks. Consideration should be given to use of other approved therapies to control the patients’ psoriasis.
The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.
Patients using Raptiva should:
Be aware that Raptiva increases the risk of developing PML. PML is a disease that is fatal or causes severe disability.
Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
Contact their healthcare provider immediately if they experience these symptoms.
Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML
In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.
According to Reuters, Genentech Inc (DNA.N) is developing plans to minimize the risks of a deadly infection reported in patients who took the company’s Raptiva psoriasis drug, a company spokeswoman said on Thursday.
The European Medicines Agency recommended suspension of Raptiva’s marketing approval after three confirmed reports of progressive multifocal leukoencephalopathy, or PML. U.S. regulators said they were reviewing the cases.
“We are evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan,” Genentech spokeswoman Tara Cooper said.
Genentech markets Raptiva in the United States. Merck Serono, a unit of Merck KGaA (MRCG.DE), holds marketing rights to Raptiva in Europe. (Reporting by Lisa Richwine, editing by Lisa Von Ahn)
Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with RAPTIVA . These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with RAPTIVA. If a patient develops a serious infection, RAPTIVA should be discontinued and appropriate therapy instituted.
Progressive Multifocal Leukoencephalopathy PML) resulting from JC virus infection has occurred during therapy with RAPTIVA.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html
12/15/07 – Study Finds Much of Private-Sector Consumer Medication Information Not Consistently Useful
A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications.
The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that while most consumers (94 percent) received CMI with new prescriptions, only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006.
“The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals.”
CMI has been defined as being useful if it includes scientifically accurate, unbiased information that is presented in an understandable and legible format. Specifically, CMI should include the drug name and uses, how to monitor for improvement in the condition being treated, contraindications (situations when the medicine should not be used), symptoms of serious or frequent adverse reactions and what to do, and certain general information, including statements encouraging patients to talk to their health care professional.
“We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution,” said Woodcock.
In early 2009, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the study’s findings. In addition, the FDA has created a Web site to receive public comment on the study and solicit feedback on the best ways to provide useful prescription information to consumers.
If you or someone you love was injured by the severe side effects of Defective Drugs you may be entitled to pursue financial compensation for your pain and suffering, but if you wait too long laws called statutes of limitations could prevent you from pressing your case. Let a dedicated and experienced defective drug attorney help you get you the restitution you deserve.
Digitek – A condition known as digitalis toxicity, symptoms of this condition include nausea, vomiting, dizziness, and bradycardia, which is a dangerously low resting heart rate.
Heparin FDA Recall -The Heparin recall was initiated because the multiple-dose injections allegedly lead to serious and almost immediate side effects
Update Aug. 27 The makers of the type 2 diabetes drug Byetta reported Tuesday the deaths of four more people who’d been taking the medication.
Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases.
Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with Byetta from the less severe form of pancreatitis.
The FDA is warning patients taking Byetta that there have been “very rare case reports of pancreatitis with complications or with a fatal outcome.”
Six more reports of patients developing pancreatitis while taking Byetta. Two patients died and 4 were recovering.
Regulators stressed that patients should stop taking Byetta immediately if they develop signs of acute pancreatitis, a swelling of the pancreas that can cause nausea, vomiting and abdominal pain. The FDA warned that it is very difficult to distinguish acute pancreatitis from less dangerous forms of the condition.
The FDA announcement updated an October alert about 30 reports of Byetta patients developing pancreas problems. At that time Byetta’s makers agreed to add information about the reports to the drug’s label.
However, the FDA made clear Monday that it is seeking a stronger, more prominent warning about the risks.
Amylin and Eli Lilly said in a statement that patients taking Byetta have shown “very rare case reports of pancreatitis with complications or with a fatal outcome.” The companies added that diabetes patients are already at increased risk of pancreatitis compared with healthy patients.
The pancreas produces several important biological fluids, including insulin — the sugar-regulating hormone that most diabetics lack.
If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery. Byetta should not be restarted. Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.
Read the complete MedWatch 2008 Safety Summary, including a link to the ‘”Information for Healthcare Professionals”
Byetta Lawyers are available for free consultations for people who have been affected by the side effects of this drug.
Pfizer Inc.’s once promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group’s report about serious physical side effects prompted the Federal Aviation Administration to ban the drug’s use by pilots and air traffic controllers.The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements.
“We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury,” the researchers said in the report.
FAA spokesman Les Dorr said the Chantix ban is effective immediately and that the agency was notifying unions representing pilots and controllers. He said the FAA is unaware of any aviation accident caused or contributed to by Chantix. Pfizer, in a statement, reaffirmed its stand on the drug’s safety and said the label already contains safety warnings about driving or operating machinery.
Heart problems and heart failure are two of the leading causes of death in the United States every year. As a result, pharmaceutical companies everywhere are placing a high priority on the research and development of medications that will provide relief and the ability to manage these conditions for patients.
Unfortunately, every new drug hits the market with at least some degree of risk, and that appears to have been the case with a drug that’s been known under several names, including Digitek, which was formulated by Actavis Totowa LLC, Bertek, distributed by Mylan Pharmaceuticals, Inc. and UDL, which is put out by UDL Laboratories, Inc. All of these drugs have been recalled, effective immediately, according to an announcement by the companies in conjunction with the FDA on its Web site.
The problem with these drugs is that many of the pills that were manufactured were released with twice the normal thickness in other pills, which means by result that these faulty pills can contain twice the amount of medication necessary to treat these heart conditions. When a patient inadvertently doubles the dose of this drug, he or she can suffer from digitalis toxicity, particularly in this situation when the patients have experienced renal failure. This condition can lead to vomiting, nausea, low blood pressure, dizziness and a dangerously low resting heart rate, known as bradycardia.
If you are taking any form of this medication, you need to contact your doctor immediately to find out how you should proceed. If you’ve been injured by any of these medications, contact a defective drugs attorney as soon as possible to schedule an initial consultation.
Nevada health officials announced that they received information about evidence of another hepatitis C case related to the first outbreak at the Shadow Lane facility that was closed down last week.
This came Several weeks after a procedure was performed at the Desert Shadow clinic, the patient’s doctor diagnosed the infection, according to officials. This was not reported to the district, as is required by state law, health officials said.
“Had the doctor reported this to us, maybe we would have been able to find it back in 2006 and eliminated any potential for disease transmission,” said Brian Labus, chief epidemiologist for the health district.
The city of Las Vegas shut down an the Endoscopy Center of Southern Nevada Friday just days after it was found that 40,000 patients might have been exposed to Hepatitis C and Aids because of the center’s medical practices.
In a news conference Friday, Mayor Oscar Goodman said that the clinic’s business license is suspended until further notice. After the last 6 patients for the day completed their treatment, the doors were locked.
“The city now has the business license in hand,” Goodman said. “They don’t have a license to do business in the city of Las Vegas.”
On Wednesday, health officials said 40,000 people who were treated at the clinic from March 2004 to Jan. 11 of this year should be tested for hepatitis B, hepatitis C and HIV, the virus that causes AIDS.
State and federal investigators told the city that members of the clinic’s nursing staff knew of the poor techniques, which included reusing syringes when drawing medicine from vials, and sharing vials among patients, resulting in cross contamination.
The nurses said they were told to cut those corners by their bosses, even though they knew they “risked contaminating patients with life communicable diseases.”
One investigator told Jim DiFiore, the business services manager, “It’s very hard to believe that they won’t do it again.”
The city offered a post-suspension hearing on Monday at City Hall.
Stryker Howmedica Osteonics manufactures femoral hip components that are used for surgical implants.
The FDA has warned Stryker to fix the hip implant problems: In a letter to Stryker Federal Regulators wrote:
“Your firm has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence,” the letter states.
The FDA said it was aware that the company has received patient complaints starting January 2005 on many existing problems. Reported problems include improper fitting of hip implants that has caused bone fractures. Patients were also known to have complained about pain, difficulty walking and “squeaky” joins, and some have even had pieces of the implant parts break off.
“We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury,” the researchers said in the report.