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Post by unlawflcombatnt on Oct 2, 2010 11:27:06 GMT -6
from Yahoo News/Reuters: J&J admits misleading U.S. Motrin recallThu Sep 30, 2010 " Already battered by a wave of product recalls, Johnson & Johnson acknowledged on Thursday it had misled consumers and U.S. regulators as it quietly removed its Motrin painkiller from the market.
Company officials underwent another grilling in Congress with the consumer giant facing a widening criminal probe and struggling to move beyond a damaging series of recalls that has pulled nearly 200 million bottles of its medicine from U.S. shelves this year, including top-selling children's medicines.
Lawmakers angrily accused the company of placing profits over the welfare of its customers, and J&J officials said their McNeil unit should have alerted stores and the Food & Drug Administration to the 2009 Motrin recall, rather than buying back the stock through contractors posing as customers.
"I believe McNeil should have handled things in a more straightforward manner," said Colleen Goggins, head of J&J's McNeil consumer unit.
The Motrin case came to light earlier this year as lawmakers probed other recalls that have eroded consumer trust and spawned lawsuits against J&J, one of the United States' most iconic companies and in business since 1886.
Some adult Motrin packages were pulled from more than 200 stores before the company alerted the FDA to its actions, according to internal company e-mails released by the House of Representatives Oversight and Government Reform Committee.
The FDA was told of the Motrin recall in April of 2009, but was not alerted to its breadth or how it would be conducted until three months later, an agency official said. It then called on McNeil to conduct a formal recall.
"There were contractors going out, telling people to act like regular customers and (to) not really tell the truth about what they were doing in the stores," said FDA Deputy Commissioner Joshua Sharfstein.
Sharfstein told lawmakers the Department of Justice had launched a criminal probe into the Motrin case. The department declined to comment.
The U.S. attorney's office in Philadelphia is already probing J&J over this April's recall of more than 40 potentially contaminated children's medicines such as Children's Tylenol and Benadryl.
Johnson & Johnson's chief executive sought to assure angry lawmakers and the public that the drugmaker had changed its ways in the wake of the recalls.
"This was not one of our finer moments," J&J CEO William Weldon told the panel.
The committee called the hearing after a session in May that lawmakers said cast doubts on the company's earlier testimony and the extent of the Motrin case.
An email released by the committee shows a worker for one contractor knew the buyback could be viewed negatively.
Pulling specific faulty lots "will take time and may draw suspicion to what we are doing," an employee for Inmar Inc. told McNeil managers. "Some stores will not care, others will ask specifically what we are doing."
GETTING BUYERS BACK
This year's recall of children's medicines was prompted by an FDA inspection that found filthy equipment and contaminated ingredients at a Pennsylvania factory. Problems with a Puerto Rico plant triggered other recalls.
Company and FDA officials say there have been no reported injuries from the recalled medicines.
Weldon said the company is spending $100 million to improve McNeil's manufacturing and said at least one product -- grape-flavored Liquid Children's Tylenol -- would be back on the market next week.
The company has also fired some McNeil employees, said Goggins, who is due to retire March 1.
The withdrawals have left many store shelves bare of liquid children's medicines with cheaper, store brands trying to fill the gap. That's been a potential boon for companies like Perrigo Co., which makes generic alternatives.
Experts have said J&J will have to work hard to convince buyers to come back to its pricier, brand-name alternatives once production resumes.
Weldon has not announced any plans to retire, but the recalls have marred his largely successful 8 years at the helm. Analysts say he is secure in his job.
"This may create a bigger black eye for J&J, but I'd be pretty surprised if it will push Weldon out of his position," said Morningstar analyst Damien Conover....
NEXT STEPS
Republicans on the committee said some of the blames lies with the FDA, which could have acted sooner.
"It looks like there was much too much of a cozy relationship," said Republican Representative Jason Chaffetz.
FDA's Sharfstein said the Motrin incident highlights the agency's reliance on voluntary company actions and the need for greater agency power to demand recalls.
Committee Chairman Edolphus Towns hopes to pass legislation giving the agency that authority, but Congress is unlikely to act in the few weeks it will be in session after the November congressional elections.
Towns said that even if the FDA was technically aware of the Motrin recall, it did not excuse what J&J did. "Johnson & Johnson had both the legal and the moral obligation to do the right thing, and they did not," he said. (Reporting by Susan Heavey; Additional reporting by Ransdell Pierson in New York and Jeremy Pelofsky in Washington; Writing by Andy Sullivan; Editing by Lisa Von Ahn, Matthew Lewis and Tim Dobbyn)"
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Post by unlawflcombatnt on Oct 2, 2010 11:31:12 GMT -6
from USA Today/AP Tylenol recall expanded to Motrin, Benadryl, more Jan 21, 2010 " Johnson & Johnson issued a massive recall Friday of over-the-counter drugs including Tylenol, Motrin and St. Joseph's aspirin because of a moldy smell that has made people sick. It was the second such recall in less than a month because of the smell, which regulators said was first reported to McNeil in 2008. Federal regulators criticized the company, saying it didn't respond to the complaints quickly enough, wasn't thorough in how it handled the problem and didn't inform the Food and Drug Administration quickly.
FULL LIST: Recalled products
RELATED: U.S. Attorney: Johnson & Johnson paid kickbacks to boost sales
The recall includes some batches of regular and extra-strength Tylenol, children's Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children's Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph's aspirin.
The FDA and Johnson & Johnson's McNeil Consumer Healthcare Products said they did not know the number of bottles recalled. It included caplet and geltab products sold in the Americas, the United Arab Emirates, and Fiji.
The FDA said about 70 people have been either sickened by the odor — including nausea, stomach pain, vomiting and diarrhea — or noticed it.
The smell is caused by small amounts of a chemical associated with the treatment of wooden pallets, Johnson & Johnson said. The FDA said the chemical can leach into the air, and traced it to a facility in Las Piedras, Puerto Rico.
The New Brunswick, N.J., company said it is investigating the issue and will stop shipping products with the same materials on wooden pallets. It has asked suppliers to do so as well.
The FDA said McNeil knew of the problem in early 2008 but made only a limited investigation.
"McNeil should have acted faster," said Deborah Autor, the director of the FDA's Office of Compliance of the Center for Drug Evaluation and Research. "When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary action to solve the problem."
The FDA sent McNeil a warning letter for violating manufacturing standards and failing to report and investigate the problem in a timely way, Autor said.
Johnson & Johnson has 15 days to respond. The FDA says it wants an explanation as to why the problem was not made public sooner.
In November, McNeil recalled some Tylenol Arthritis Caplets due to the smell. Almost 3 weeks ago, the company expanded its recall to include more batches of Tylenol Arthritis Caplets....
Also on Friday, federal prosecutors in Boston said Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia drug.(Risperdal)
The government's complaint states that J&J gave special rebates to Omnicare Inc., the country's biggest dispenser of prescription drugs to nursing homes, in return for recommendations from its pharmacists that patients be given Risperdal, in many cases when it was inappropriate.
J&J said in a statement it "will address the government's lawsuit in court" and believes its rebates were "lawful and appropriate."
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Post by jeffolie on Oct 2, 2010 11:40:05 GMT -6
Americans need protection from evil BIG PHARMA.
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Post by jeffolie on Oct 2, 2010 11:41:19 GMT -6
unlawflcombatnt
Thank you for presenting this.
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Post by unlawflcombatnt on Oct 4, 2010 1:33:06 GMT -6
unlawflcombatnt Thank you for presenting this. You're welcome.
And that's not all that Johnson and Johnson has been up to. They have been accused of paying kickbacks to promote their drug Risperdal. And though some part of the charges may have been dropped, there are outright admissions from employees that they were paying kickbacks.
Certainly these admissions could have been falsified. But there is a lot of anecdotal evidence that Risperdal, and drugs like it, have been promoted by the drug companies themselves for off-label usage.
from USA Today/AP:U.S. Attorney: Johnson & Johnson paid kickbacks 1/15/2010 " Johnson & Johnson allegedly used kickbacks to Omicare to increase prescription recommendations of the schizophrenia drug Risperdal.
Federal prosecutors said Friday that health care giant Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes would put more patients on its blockbuster schizophrenia medicine and other drugs.
In a complaint filed Friday, prosecutors said J&J paid rebates and other forms of kickbacks to Omnicare, the country's biggest dispenser of prescription drugs in nursing homes. Prosecutors allege Omnicare pharmacists then recommended that nursing home patients with signs of Alzheimer's disease be put on the powerful schizophrenia drug Risperdal, which was later found to increase risk of death in the elderly.
The allegations are in a complaint filed by the U.S. Attorney in Boston, whose office has joined two whistle-blower cases. One was filed in 2003 by a former Omnicare pharmacist in Chicago, Bernard Lisitza, who alleges he was fired after he challenged the Risperdal kickbacks and other improper practices at the company. The other was filed by former Omnicare financial analyst David Kammerer in 2005, after he resigned from the company.
"Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving," U.S. Attorney Carmen Ortiz said in a statement. "Nursing home doctors should be able to rely on the integrity of the recommendations they receive from pharmacists, and those recommendations should not be a product of money that a drug company is paying to the pharmacy."
Johnson & Johnson, based in New Brunswick, N.J., said in a statement it is reviewing the complaint and "will address the government's lawsuit in court. We believe airing the facts will confirm that our conduct, including rebating programs like those the government now challenges, was lawful and appropriate. We look forward to the opportunity to present our evidence in court."
Ortiz's office is seeking triple damages, restitution and other penalties under the federal False Claims Act and other laws. The damages would be based on the amount of false claims charged to Medicaid, which paid for about two-thirds of the claims on the care submitted for J&J drugs — possibly hundreds of millions of dollars.
Separately, Johnson & Johnson said Friday it's expanding a recall of over-the-counter medications, due to a moldy smell that has made users sick, from Tylenol to some other brands.
In afternoon trading, Johnson & Johnson (JNJ) shares fell 86 cents to $64.24.
"The government's complaint paints a sordid picture of J&J payola driving sales of drugs in nursing homes," said Michael Behn, a Chicago attorney who filed the whistle-blower complaint in October 2003 on behalf of Lisitza. "Pharmacists are trusted professionals. There can be zero tolerance for kickbacks."
The government's motion to intervene in the case was approved last month.
Its complaint alleges the scheme went on from 1999 through 2004, a period when J&J's sales of drugs through Omnicare jumped from about $100 million to more than $280 million. More than one-third of that was sales of Risperdal; the other drugs were pain relievers Duragesic and Ultram and an antibiotic, Levaquin.
Soon after that, the Food and Drug Administration required Risperdal to be sold with its most severe, "black box" warning, stating that giving Risperdal and similar drugs to elderly patients with dementia-related psychosis increased their risk of death. The warning states the use of Risperdal is not approved for patients with dementia-related psychosis — schizophrenia and other mental illnesses causing delusions and hallucinations.
Yet an Archives of Internal Medicine study published Monday covering nearly 17,000 nursing home residents around the country found one-third of those getting antipsychotic medications in 2006 didn't have appropriate symptoms. In addition, nursing homes that already had the highest rates of antipsychotic medication use were much more likely to give those drugs to new patients as they arrived. Such drugs leave patients sedated — in what's called a chemical restraint — most of the time, making them easier to manage, particularly in nursing homes with insufficient staff.
Risperdal brought J&J $1.73 billion in sales in the first nine months of 2009, nearly 4% of its $45.3 billion in total revenue. Sales have been falling recently due to generic competition to one version.
Last November, Omnicare agreed to a $90 million settlement with the federal government and numerous states to resolve its liability in the case, according to Ortiz.
The complaint states that Johnson & Johnson knew Omnicare pharmacists reviewed the charts of nursing home patients at least once a month, then made recommendations to physicians on what drugs patients should be getting. The complaint alleges J&J knew physicians accepted those recommendations more than 80% of the time and states that J&J considered those pharmacists an "extension of (J&J's) salesforce."
The government alleges Omnicare agreed to operate "Active Intervention Programs" to increase prescribing of J&J drugs, and that Johnson & Johnson paid for that with so-called "grants" and "educational funding," and other methods that allowed it to evade requirements to pay government health programs equivalent rebates.
Under one of the programs, called the "Risperdal Initiative," physicians were persuaded to prescribe Risperdal to patients with "behavioral disturbances associated with dementia," the government alleges.
Besides Johnson & Johnson, the complaint names 2 of its subsidiaries as defendants: Ortho-McNeil-Janssen Pharmaceuticals, which makes and sells Risperdal and other drugs, and Johnson & Johnson Health Care Systems, which entered into contracts with Omnicare." Interestingly enough, when I try to get references to these earlier articles on Johnson and Johnson, my computer is blocked or even locked up when I try.
How convenient.
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Post by unlawflcombatnt on Oct 4, 2010 1:35:58 GMT -6
Sales Rep Told Docs To Use Risperdal Off-Label By Ed Silverman Oct 29th, 2009 " The admission came from Matt Thompson, a sales rep for Johnson & Johnson’s Janssen unit, who testified in a trial over claims by a former co-worker. In 2002, he said he pushed docs to consider prescribing Risperdal in combination with other drugs, even though this wasn’t approved by the FDA, and he noted that Jannsen’s training didn’t include any specific prohibitions against such promotions.
“I’m not saying the company tried to hide it, but we didn’t think about augmentation in the realm of on-label or off- label at that time,” Thompson said. He said he was “probably” aware that promotion of such sales was illegal, Bloomberg News reports.
The lawsuit was brought by Lynn Powell, 36, who claims she was fired in 2004 for complaining inside Jannsen about pressure to promote Risperdal for children and bipolar disorder patients when it was approved only for adults with schizophrenia, Bloomberg writes. Thompson was her supervisor when she was fired. J&J attorneys deny the claims and say Powell was fired for violating a ban on off-label promotion."
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Post by unlawflcombatnt on Oct 4, 2010 1:42:54 GMT -6
from Bloomberg: J&J Salesman Says He Sold Drug for Unapproved UsesBy John P. Martin, Margaret Cronin Fisk and David Voreacos - Oct 28, 2009 " A sales representative for Johnson & Johnson’s Janssen Pharmaceutica unit testified that he encouraged doctors to prescribe the antipsychotic drug Risperdal for unapproved uses.
Matthew D. Thompson, testifying today in a trial over claims by a former co-worker, said that in 2002 he pushed doctors to consider prescribing Risperdal in combination with other drugs, so-called augmentation therapy, even though government regulators hadn’t approved this use. Janssen’s training didn’t include any specific prohibitions against promoting the drug that way, he said.
“I’m not saying the company tried to hide it, but we didn’t think about augmentation in the realm of on-label or off- label at that time,” Thompson said. He said he was “probably” aware that promotion of such sales was illegal.
Thompson was the third witness called in the case of Lynn Powell, 36, who claims she was fired in February 2004 for complaining within the company about pressure to promote Risperdal for children and bipolar disorder patients when it was approved only for adults with schizophrenia. Thompson was Powell’s supervisor when she was fired.
Attorneys for New Brunswick, New Jersey-based Johnson & Johnson deny the company condoned such practices. They said Powell was fired for violating its ban on off-label promotion.
Sales Training
The Janssen sales staff was trained specifically not to promote sales for augmentation therapy, said Michael Walsman, the unit’s former national sales director.
“We did not promote augmentation therapy,” Walsman testified today. “That was something we did not approve or do.” Walsman oversaw sales of Risperdal for more than a dozen years until his retirement in 2005.
The Powell lawsuit is the first Risperdal sales case to go before a jury. The Justice Department is investigating off-label marketing at Janssen and in the industry. Ten states sued Johnson & Johnson over Risperdal sales practices, including claims it violated a U.S. ban on off-label marketing. The Powell trial began in state court in Trenton, New Jersey, yesterday.
Thompson testified he was a sales representative in the Detroit area in 2002 for a Janssen sales force whose primary product was Risperdal. In one of his notes after a doctor’s visit, Thompson wrote that he was “working intently” to get the physician to try Risperdal in combination with another drug. In another, he wrote that he had “pushed” a doctor to prescribe higher levels of Risperdal in augmentation therapy.
‘Were You Aware?’
“In 2002, were you aware that making off-label claims was illegal?” Powell’s attorney, John Thurman, asked him today.
“I probably was,” Thompson replied.
Thompson was shown reports he filed after field visits with salespeople in 2003, including one describing a sales rep pressing a doctor for children and adolescents to consider Risperdal. Thompson commended the saleswoman for her skills in the sale, according to the report. He agreed under questioning that this was clearly off-label marketing.
“I did not think it was okay,” he said. He didn’t report her to superiors, he said.
Under federal law, drugmakers are barred from promoting drugs for unapproved, or off-label uses. Doctors are allowed to prescribe drugs for such uses.
Promoted in 2002
In late 2002, Thompson was promoted to a district manager in Raleigh, North Carolina, where Powell was one of his sales representatives.
Powell began selling Risperdal in 2000 in the Raleigh area and was trained to promote off-label use to doctors and hospitals, her lawyer said in opening statements yesterday.
Powell became uncomfortable with the practice in 2003 when she was told to sell Risperdal at a children’s psychiatric facility and one for the mentally retarded, Thurman said. She claims she was fired for objecting to such sales.
Walsman, the former Janssen executive, said sales representatives received extensive training each year that included warnings against promoting drugs for off-label uses.
Under questioning from J&J lawyer Thomas Scrivo, he read aloud portions of training manuals and a 2002 memo from Janssen’s then-President Alex Gorsky specifically noting that off-label sales were illegal and could compromise the company’s reputation.
“The issue of proper promotion of our products was a constant thing,” Walsman testified.
Top Salesperson
In 2003, Powell was honored as the top salesperson in her region, generating about $1.6 million in sales. She and her sales partner ranked 12th out of 250 teams nationally, Walsman said.
He said he was unaware of Powell’s concerns or the allegations against her until after she was fired.
“The only thing I knew was that she had been terminated for off-label promotion,” he said."
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