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New York Times: Merck had earlier Vioxx info
Newspaper says drug maker had preliminary results from earlier study that showed heart complications.
November 18, 2004: 7:47 AM EST
NEW YORK (Reuters) - Merck & Co. Inc. had results from a study that indicated Vioxx increased the risk of heart attacks and stroke almost a year before receiving other information that led to withdrawal of the arthritis drug, a newspaper reported Thursday.
Pharmaceutical maker Merck recalled Vioxx on Sept. 30 after a long-term clinical trial showed it doubled the risk of heart attack and strokes in patients who had taken it for more than 18 months to prevent recurrence of colon polyps.
The New York Times reported that Merck got preliminary results -- which have not been disclosed -- last November from an earlier, separate study that led to some similar conclusions.
It added that a final report from the study, confirmed by a company spokeswoman, was given to Merck 10 days before the Vioxx withdrawal was announced.
The Times quoted the spokeswoman as saying that the separate study's results were inconclusive and were not a factor in the drug's withdrawal because they were based on patient records from UnitedHealth Group (Research) and not a clinical trial.
But a person briefed on the data who spoke anonymously to the paper said the results showed Vioxx could lead to a higher risk of cardiovascular problems versus some other drugs.
Senate hearing begins
Further light will be shed on how Merck handled the Vioxx situation when a Senate Finance Committee hearing on Thursday features e-mails and other internal documents reviewed by the Wall Street Journal.
The e-mails and other documents showcase tensions at Merck and the Food and Drug Administration along with communications by Edward Scolnick, Merck's research chief, the Journal reported Thursday.
The e-mails include complaints by Scolnick that a Merck marketing executive had concerns that a rival drug could get more favorable labelling from the FDA than Vioxx.
According to the Journal, another e-mail has Scolnick requesting that a statistician at Merck let him see results of a trial before he was supposed to.
Another has him saying he "nearly strangled" an FDA staffer, the Wall Street Journal said, but a Merck spokeswoman told the newspaper this was "hyperbole" and added the documents have been taken out of context.
Merck (Research), whose shares closed at $27.34 Thursday on the New York Stock Exchange, was not immediately available for comment.
Quiet scientist no more
By Rita Rubin, USA TODAY
OLNEY, Md. - Scientist, father, husband and scoutmaster David Graham recently added another job to his résumé. Unlike the others, though, it's one he never sought.
"FDA made me into a whistle-blower," Graham, a scientist in the Food and Drug Administration's Office of Drug Safety, said in a three-hour interview Saturday at a coffee shop near his home. "It wasn't my intention to be a whistle-blower.
"All I wanted to do was a study on Vioxx."
As a result of that study, Graham - who for the most part has worked in the relative obscurity typical of an FDA scientist - has appeared recently on Nightline, CNN and Good Morning America. His photo has run in major newspapers across the country. All this because he testified before a Senate panel Nov. 18 that the FDA, his employer for 20 years, is incapable of protecting the public from dangerous drugs once they come on the market.
"What I'm painting is a picture of an FDA that is completely insensitive to drug safety," Graham says.
On Saturday, no one seemed to recognize the wiry 50-year-old, clad in jeans, checked shirt and fleece vest, as he sipped his usual decaf mocha with skim milk and talked passionately about his new role as whistle-blower.
One customer did walk over to ask him to stop talking so loudly about bowel movements, part of his discussion of Lotronex, a drug for irritable bowel syndrome. It came back on the market after it was withdrawn because of safety concerns.
The study that has thrown Graham into the limelight involved analyzing a database of 1.4 million Kaiser Permanente members. Graham and his collaborators compared the rate of heart attacks and sudden cardiac deaths in patients who took Vioxx or Celebrex, its main competitor, or other non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.
"We did this study because I recognized Vioxx was a potential disaster," Graham says. It had all the ingredients: a blockbuster drug used by millions that carried a significantly increased risk of heart attacks, the leading killer in industrialized countries. "I don't think that (FDA management) appreciated what we might find."
Graham and his collaborators found that Vioxx users had a higher rate of heart attacks and sudden cardiac deaths than Celebrex users.
Initially, the study received little publicity. Graham presented his results Aug. 25 at a scientific meeting in France. But five weeks later, on Sept. 30, Merck pulled Vioxx off the market because its own study had found a higher rate of heart attacks and strokes in patients taking the drug than in those on a placebo.
Suddenly, Graham's work and questions about what the FDA knew about Vioxx and when were making headlines. A whistle-blower was born. "FDA has made a systematic attempt to block me in the exercise of my free-speech rights," Graham says.
Graham says his superiors pressured him to soften his conclusions before presenting them at the August meeting in France. In a news release the day before the Senate hearing, acting FDA commissioner Lester Crawford said Graham voluntarily revised his conclusions. "FDA encourages open and vigorous internal debate about the often difficult scientific questions it routinely faces," Crawford said.
Graham paints a different picture: "When you live in a climate of fear, retaliation and intimidation, no decision that one makes is entirely voluntary."
E-mails between Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, and Richard Horton, editor of The Lancet, a medical journal that had accepted Graham's Vioxx study, suggest that the agency tried to plant doubts about the credibility of the results.
Graham says friends at the FDA have told him that agency officials plan to force him into an administrative job. The agency, saying it could not discuss personnel matters, would neither confirm nor deny that Graham is to be transferred.
"I don't know what's at the bottom of this," Graham says. "The reaction of FDA management to my study of Vioxx is disproportionate to the study."
Sen. Chuck Grassley, R-Iowa, last week called for a government investigation into whether FDA management may have tried "to discredit an outspoken safety officer who was challenging the FDA's drug-safety policies." In a letter Monday, Grassley, chair of the Senate Finance Committee that heard Graham's testimony, asked Crawford whether he was planning to fire or transfer Graham against his wishes.
Graham says he has many supporters among the agency's rank and file as well as the public. Colleagues gathered in a cafeteria to watch a broadcast of his Senate testimony. When he returned to work the next day, they greeted him with hugs, kisses and pats on the back.
Graham says he has received hundreds of e-mails and telephone calls. Nearly all, he says, are variations on "thank you so much. You're in our prayers. We appreciate what you are doing. This must be so hard on your family."
Graham says he has heard concerns similar to his from counterparts who monitor medical devices and biologics, such as vaccines, but they're reluctant to come forward.
"They are absolutely afraid for their jobs," Graham says. "We've got families to support." He's married to his college sweetheart, and they have six children ages 9 to 23.
Graham could make a fortune as an expert witness, as other former FDA scientists have, says Wayne Ray, a preventive medicine professor at Vanderbilt University and co-author on Graham's Vioxx study.
But that won't happen, Ray says. "Dave is an excellent epidemiologist. He is extremely hardworking. He's extremely honest. He's extremely conscious of data and data accuracy. And he's very devoted to public health. Given those characteristics, I think the job he wants most is the job he has now."
March 1, 2004
Re: Safety data on Zyprexa ® (olanzapine) - Hyperglycemia and Diabetes
Dear Doctor,
Eli Lilly and Company would like to inform you of important labeling changes regarding Zyprexa (olanzapine). The Food and Drug Administration (FDA) has asked all manufacturers of atypical antipsychotic medications, including Lilly, to add a Warning statement describing the increased risk of hyperglycemia and diabetes in patients taking these medications, including Zyprexa. In addition to Zyprexa, the atypical antipsychotic class includes Clozaril ® (clozapine, Novartis), Risperdal ® (risperidone, Janssen), Seroquel ® (quetiapine, AstraZeneca), Geodon ® (ziprasidone, Pfizer), and Abilify ® (aripiprazole, Bristol Myers Squibb and Otsuka American Pharmaceutical). Accordingly, the Zyprexa prescribing information has been updated with the following information:
WARNINGS
Hyperglycemia and Diabetes Mellitus
Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including Zyprexa. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
Should you have any questions or concerns regarding this important safety information, please contact your Eli Lilly and Company sales representative or contact the Lilly medical department at 1-800-Lilly-Rx . Please refer to the full prescribing information for Zyprexa included with this letter. As always, we request that serious adverse events be reported to Lilly at 1-800-Lilly-Rx or to the FDA MedWatch program by phone (1-800-FDA-1088 ), by fax (1-800-FDA-0178 ) or by email (www.fda.gov/medwatch).
Sincerely,
Dr. Paul Eisenberg
Vice President, Global Product Safety
Eli Lilly and Company
The New York Times
National Briefing Science and Health: New Risk From Hormone Replacement
October 6, 2004
A study that has already linked hormone replacement therapy to an increased risk of stroke, heart attack and some cancer also uncovered a hazard for blood clots, researchers said. The study, the Women's Health Initiative, found that women taking estrogen plus progestin at the strength once commonly used had a double risk of venous blood clots, which can travel to the lungs and be fatal. The combination is most often sold in the United States by Wyeth as Prempro. The Food and Drug Administration recommends that for relief from menopausal symptoms women should use such drugs at the lowest effective dose and for the shortest time necessary.
Los Angeles Times
February 12, 2004
Consumers Sue Wells Fargo, Bank of America
Two suits seek damages over auto leases, while a third seeks the return of ATM fees to Bank of America customers.
Challenging California's biggest banks, consumers have filed lawsuits accusing Bank of America Corp. and Wells Fargo & Co. of improperly collecting sales tax at the end of automobile leases, and claiming that Bank of America failed to adequately disclose certain fees at automated teller machines.
The suits, filed Tuesday in Los Angeles County Superior Court, seek certification as class actions representing customers throughout the state. Two suits demand unspecified damages for tens of thousands of Californians who have leased cars through the banks, while a third seeks the return of ATM fees to potentially millions of Bank of America customers.
San Francisco-based Wells Fargo said it didn't comment on litigation. A spokeswoman for Charlotte, N.C.-based Bank of America said lawyers hadn't studied the suits enough to comment.
Bank of America ATMs display a notice saying "fee may apply" when customers order statements, but state law requires notice of the actual fees, which are $3 for a complete statement and $1 for an abbreviated version, according to a suit filed by Pasadena lawyers Tina B. Nieves and Hector Gancedo. The suit said the bank also charged customers of other banks undisclosed fees of $1.25 for account balance inquiries.
Two additional cases take aim at the sales taxes on the termination fees that banks charge at the end of auto leases.
California regulations require leasing companies to charge state and local sales tax on regular lease payments, the suits said, but not on costs "incurred in disposing of the leased property at expiration or earlier termination of the lease."
When Marc I. Lavin of Los Angeles turned in his leased Audi in October 2002, Wells Fargo charged him $20.63 in sales tax on top of the $250 termination fee, one suit says.
Bank of America also charged $20.63 in sales tax on top of a $250 termination fee when Michael Brown of Los Angeles returned his Chevrolet in July 2003, according to the other suit.
"One major question will be what happened to the money," said Andrew H. Selesnick of Encino, one of the lawyers who filed the suit. "Will they be able to show us they remitted it to the state or did they stick it in their pockets as profit?"
Selesnick said some other auto-leasing companies, including those for Volvo and Mercedes-Benz cars, didn't charge California sales tax on termination fees, also called disposition fees.
California Fen-Phen Litigation Update
NORWALK, California- Approximately
650 lawsuits have been filed statewide against the manufacturers
and distributors of phentermine, fenfluramine and dexfenfluramine,
the prescribing doctors and diet centers which dispensed the diet
drugs. Fenfluramine, phentermine and dexfenfluramine were approved
for individual use by the FDA but were never approved for use in
combination with one another. In 1992, articles were published about
study results suggesting that the combined use of phentermine and
fenfluramine "Fen-Phen" would result in dramatic weight
loss when used over an extended period of time. Subsequently, an
estimated six million Americans were prescribed these diet drugs.
Following a ground swell of research linking these drugs to heart
valve disease, however, the Food and Drug Administration pulled
fenfluramine and dexfenfluramine from the market in September 1997.
Since then, lawsuits have been pouring into courts around the country.
The individual cases seek damages for personal injury ranging from
heart valve damage to a rare but fatal lung disease, primary pulmonary
hypertension, allegedly caused by use of the Fen-Phen combination.
Several wrongful death cases have also been filed.
California Litigation: TV Suit, Class Action, Prayer Lunches and More
Andrew White jumps networks; a small firm takes on big game
By Gail Diane Cox, The National Law Journal, February 6, 2001
ABC's prime-time trial attorney over the past decade, Andrew M. White, is going to court for The Eye. On Jan. 19, CBS -- represented by White, O'Connor, Curry, Gatti & Avanzado -- sued Carsey-Werner Productions in Los Angeles Superior Court for $50 million-plus.
Both sides are "quite guarded" about airing their dispute in public, says White, considerably less voluble than usual.
The lawsuit says that CBS lent Carsey-Werner Productions the money to produce the television series "Cybill" with the understanding that Carsey-Werner would make a good-faith effort to pay it back out of syndication profits. Except, CBS complains, the Studio City, Calif.-based production company sought to find rerun markets for its other shows rather than the Emmy-winning sitcom because "syndication deals for those projects would generate profits that defendants would not have to repay CBS."
Carsey-Werner's stable of programs includes "Roseanne," "The Cosby Show" and "3rd Rock From the Sun." Its spokesman isn't speaking.
Let the Sunshine In
San Diego County's local rules of court, which frown on closed-door sessions in general and on confidential settlements in particular, were a model for reformers at last October's meeting of the state Judicial Council.
Now it looks like we'll be able to see how well the system performs in a low-stakes but politically charged case.
The San Diego Union-Tribunesued on Jan. 26, seeking the details surrounding a quick $17,000 settlement that the county cut with Giovanna Vinsconi.
Vinsconi worked for the chairman of the county Board of Supervisors before she was fired, and she says that she got in trouble for not wanting to organize -- on county time -- a prayer luncheon for a private group.
Aftershocks
It's a "myth" that a law firm needs a wad of cash and depth on the bench before it undertakes a class action against corporate big boys, says Tina Nieves. Her minority-owned, Pasadena, Calif.-based firm Gancedo & Nieves started up three years ago "out of thin air -- as in, we had to arrange financing," she says. Employing all of five lawyers today, the firm is supporting major cases against Warner Lambert Co., Lockheed Martin Corp. and American Home Products Corp. But any penny-pinching days may be over.
On Jan. 30, a judge approved the $7 million settlement of Gancedo & Nieves' federal class action against Pilot & Associates. The company provides insurance companies with adjusters who work in the field after disasters, and the plaintiff/adjusters alleged that they worked around the clock in the aftermath of the 1994 Northridge earthquake without adequate overtime and other benefits. Sharing the fees with Nieves' firm is co-counsel Stephen C. Ball, a sole practitioner, also of Pasadena.
Daly Event
Movie producer John Daly says that he got caught in the cross-hairs when his company, Hemdale Film Corp., went belly-up -- and it's all allegedly the fault of New York's Skadden, Arps, Slate, Meagher & Flom for not adequately protecting his interests when he guaranteed a bank loan for Hemdale.
Daly has sued Skadden for $100 million, alleging legal malpractice and raising conflict-of-interest charges.
In response, the managing partner in Skadden's Los Angeles office, Rand April, came close to commenting on Daly's affinity for courtrooms -- then reconsidered, with a judicious "I'd better not." But the Los Angeles Times went on the record years ago with the observation that the British-born Daly has "a reputation for being frequently embroiled in litigation."
In the 1980s, Daly won back-to-back Oscars for "Platoon" and "The Last Emperor," as well as critical praise for "Hoosiers." His production company -- with a library of 178 titles and creditors ranging from the Screen Actors Guild to Credit Lyonnaise Bank Nederland N.V. (CLBN) -- went into bankruptcy in 1992. Now he says that Skadden, while purporting to represent his best interests, "accepted monies from the attorneys for CLBN" behind his back in connection with the negotiation of the loan guaranty.
Ali First
When the American Law Institute gathers next May at Washington, D.C.'s Mayflower Hotel for its 78th annual convention, it'll be the group's first meeting ever with a president from the West Coast.
He's Michael Traynor, a litigator in the San Francisco office of Cooley Godward and the son of former California Chief Justice Roger Traynor.
Most recently, he made headlines worldwide representing Yahoo Inc. against a French court order barring the online auctioning of Nazi memorabilia.
Firm agrees to compensate adjustors for earthquake OT
February 01, 2001
By Virginia McCrum
Staff Writer, Pasadena Star-News
PASADENA -- Pilot and Associates Inc. has agreed to pay its adjustors $7 million in unpaid overtime compensation and other benefits for services performed after the 1994 Northridge earthquake.
The settlement, approved Tuesday by Judge Spencer Letts after a hearing in U.S. District Court in Los Angeles, was negotiated for plaintiff Lawrence Babinski et al., by two Pasadena law firms.
"We litigated for 2 1/2 years," said Tina Nieves, a partner with Pasadena-based Gancedo & Nieves law firm and one of the case's lead attorneys. "Wage violations are rampant in California. We hope that this case and others like it we are prosecuting will put an end to large companies taking advantage of their employees."
Pilot, a privately owned company based in Alabama, provides adjusters to insurance companies when they need help with disaster claims. The company was founded in 1952.
"As a cost-saving measure, large employers are deliberately misclassifying their employees, either as independent contractors or as exempt employees in order to avoid paying them legally mandated overtime wages and employee benefits," Nieves said.
Many employees in the California workplace are not even aware of the recent minimum wage increase to $6.25 an hour that pushed up the minimum wage for overtime exempt employees to $12.50 an hour, she said.
Nieves' co-counsel for the case against Pilot was attorney Stephen Ball of the Law Offices of Stephen Ball in Pasadena.
"After the Northridge earthquake, Pilot supplied adjusters to Farmers and other insurance companies," Nieves said. "More than 1,000 Pilot adjustors came to Southern California from around the country, but the settlement that was ultimately reached covers all Pilot adjusters nationwide."
Pilot had claimed in the case that the adjustors were independent contractors, not employees, and therefore not entitled to overtime wages and other benefits.
"These adjustors worked seven days a week for months on end," Nieves said. "It's stressful enough to be a claims adjuster after a disaster. It's even worse to be told you will not be properly compensated for your long hours of work."
Virginia McCrum can be reached at (626) 962-8811, Ext. 2127, or by e-mail at virginia.mccrum@sgvn.com.
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