The first civil suit against Merck, the manufacturer of the drug Vioxx, will be held in a small Texas town beginning this Thursday. Media and legal experts will be watching as Merck tries to stave off damning evidence that Merck knew of Vioxx’s heart risks and failed to conduct the necessary scientific studies before the drug was approved in 1999. The evidence that will be presented during the trial comes from company email messages as well as Merck internal memos and documents between top Merck scientists.
The manufacturer of Vioxx wants to delay the first wrongful death trial for at least 60 days. Merck & Co. filed a motion to delay the trial arguing that it can’t receive a fair trial if the case is heard next week as scheduled. Merck withdrew the drug last September when research revealed that patients who took it for 18 months or longer more than doubled their risk for heart attack and stroke. Since that time, more than 2,400 lawsuits have been filed nationwide. We are handling more than 50 cases for those who have been injured by the dangerous drug. The motion is expected to be heard Tuesday in a Wharton Texas courtroom. In the motion, lawyers for Merck cited recent publicity about the drug which, according to Merck, “effectively eliminated any possibility Merck can receive a fair trial beginning July 11.” The more important issue is fairness and justice for the victims of this dangerous drug Vioxx.
A June 17th article in the Wall St. Journal raised questions about Johnson & Johnson’s antipsychotic drug Risperdal. According to the story, government researchers found a higher incidence of benign tumors in the pituitary gland among patients taking the drug. The Journal article noted that the finding is preliminary and their is no definitive link proving the drug caused the tumors. Researchers analyzed 2.5 million adverse events reported by doctors and found that of the 307 reports of pituitary tumors 64 or 21% occurred in patients taking antipsychotics. Risperdal is a widely prescribed drug used to treat schizophrenia and bipolar disorder. Last year, it was J&J’s second biggest selling drug with world wide sales of $3.1 billion
According to a recent article in the NY Times, in 1998 the makers of the heartburn medicine Propulsid negotiated a new warning label rather than remove it from the market in spite of overwhelming evidence of its dangerous, sometimes fatal, effects. Johnson & Johnson continued to promote the drug to children in spite of evidence showing the drug caused serious heart problems. Two years later, as such reports mounted, Johnson & Johnson continued to aggressively market the drug but then abruptly pulled it from the market before a governmental hearing threatened to draw attention to the drug’s long, hidden, record of trouble. Documents from lawsuits against the drug’s manufacturer show that the company did not conduct safety studies urged by federal regulators and the company’s own consultants that could have revealed the drug’s dangers early on and saving countless lives. According to the NY Times, Propulsid’s history has “striking parallels with the painkillers now at the center of the controversy. Dozens of studies sponsored by Johnson & Johnson that might have warned doctors away were never published, just as the pharmaceutical manufacturer Pfizer failed to publish an early study of Celebrex that indicated a heart risk. And Johnson & Johnson was able to delay and soften some proposed label changes, just as Merck later did with Vioxx.” Drug companies are more concerned with profits than protecting and helping consumers.
A news story published in the Washington Post today cites problems with the FDA’s new drug oversight board. According to FDA Safety Officer David Graham, the new board is “severely biased in favor of industry” rather than consumer protection. The oversight committee was initially set up after sudden market withdrawals of painkiller drugs such as Vioxx and Bextra.
According to Iowa Senator Charles Grassley the problem with the board is its composition. 11 of the 15 members already serve on the same FDA committee approving drugs for Americans. Obviously, a truly independent review board is necessary if the American consumer is to be served and protected.
Consumers are no better off with the new board since the fox is guarding the hen house once again.
Drug maker to settle case for $300m
By Associated Press | June 6, 2005
NEW YORK — Bristol-Myers Squibb Co. is expected to settle a federal probe of its past accounting practices for $300 million, according to published reports.
As part of the so-called ”deferred prosecution” agreement, the New York pharmaceutical company would be able to avoid criminal charges if it complies with certain terms, The New York Times and The Wall Street Journal reported last night on their websites, citing unnamed sources.
An announcement of the agreement could come this week, the reports said.
Among the terms of the deal with the Justice Department are expected to be the separation of the chairman and chief executive titles held by Peter R. Dolan, and other changes in the company’s corporate governance practices.
No current Bristol-Myers Squibb executives are expected to be indicted, thought it’s possible former executives may be indicted, according to the Journal.
Retired federal Judge Frederick B. Lacey will remain on board as the company’s independent monitor of accounting, internal controls and financial-reporting practices, both papers said.
Last year, Bristol-Myers Squibb reached a $150 million accounting-fraud settlement with the SEC after it was accused of manipulating its inventory of drugs to inflate earnings.
Court: Druggists can be liable for failing to warn of risks
An appeals court rules in the case of a man whose wife died of an overdose after druggists filled her prescriptions.
By Associated Press
Published June 4, 2005
MIAMI – A Florida appeals court has ruled for the first time that pharmacists can be held liable for failing to warn people about the risks associated with the use of drugs repeatedly or in harmful combinations, even if they are filling doctors’ prescriptions.
The 4th District Court of Appeal, reversing a lower court, decided this week that Robert Powers can pursue claims of negligence against two pharmacies – Your Druggist and the Medicine Shoppe – that filled his wife’s prescriptions for neck and back pain. Gail Powers died of an overdose.
Pharmacists already must have “general knowledge” of the medicines they dispense, as well as knowledge of the risks they present, the court found.
“Thus, a strong policy basis already exists supporting a pharmacist’s duty to warn customers of the risks inherent in filling repeated and unreasonable prescriptions with potentially fatal consequences,” Judge Mark E. Polen wrote for the court.
The pharmacies plan to appeal.
Peter Herman, Powers’ attorney, said the ruling is “important because from a consumer’s standpoint, a pharmacist is probably going to be in the best position to raise a red flag.”
Gail Powers, a 46-year-old waitress, died in October 2002 from an overdose of prescription drugs. She had been taking six drugs, including the powerful painkillers OxyContin and Percocet and the antianxiety drug diazepam. These drugs can be harmful if taken together, and some are highly addictive with long-term use, according to the Food and Drug Administration.
In his lawsuit, Powers said the druggists wrongly filled all of his wife’s prescriptions without question, even though many were filled within days of previous prescriptions – raising the possibility of dangerous combinations or easy access to too many pills. The lawsuit also named his wife’s doctor, a neurologist.
The negligence claims against the pharmacies were dismissed by a trial judge in Broward County who said that, under Florida law, druggists aren’t liable if they’re filling legal prescriptions.
The 4th District Court of Appeal’s reversal of that decision Wednesday gives Powers another chance to pursue his claims. The ruling did not address whether Powers might succeed on the merits of the lawsuit.
Jay Greene, attorney for the Medicine Shoppe, said the decision will be appealed to the Florida Supreme Court within 30 days.
The appeals court, sitting in West Palm Beach, noted that its decision conflicts with rulings issued by the 1st District Court of Appeal in Tallahassee and the 5th District Court of Appeal in Daytona Beach in similar cases. But the judges cited recent cases in Pennsylvania, Arizona, Nevada, Missouri and Tennessee in which courts found that pharmacists have a duty to warn patients, doctors or both about the possible risks of using prescription drugs repeatedly, over a lengthy period or in certain combinations.
AP Business WriterTue May 24,12:49 AM ET
Pfizer Inc., GlaxoSmithKline PLC. and Merck & Co. are “making a mockery” of efforts to create more transparency in drug clinical trials, according to a prominent medical journal editor.
Dr. Jeffrey M. Drazen, editor-in-chief of the New England Journal of Medicine, said the companies are not providing enough useful details in their posting on a government trial registry and that their reluctance to provide meaningful information may hamper their ability to have their studies published in important medical publications
Last September, the members of the International Committee of Medical Journal Editors said they would not publish any studies that are not registered in a public database as they are launched. Drazen’s comments came as the editors delivered more details about what they expect from pharmaceutical companies. The group is asking for 20 disclosures, including what each study is designed to evaluate, how many patients will be studied and who is funding the research.
Drazen based his comments on a review of the information drug companies posted on www.clinicaltrials.gov., which is run by the U.S. National Institutes of Health. He said the review was conducted by Dr. Deborah Zarin of the NIH at the request of the committee.
“They (the three companies) are giving nonsense details,” Drazen said in an interview on Monday. “They are written in a way that they are trying to hide what they are doing.”
Merck spokeswoman Janet Skidmore said the company didn’t agree with Drazen’s characterization of its entries on the government web site.
“We have done everything we can to expedite medical information and enhance transparency,” Skidmore said.
Glaxo spokeswoman Mary Anne Rhyne said the company has listed 55 ongoing trials on the NIH site as well as 400 studies on its own site. Rhyne said the company intends to supply journal editors with all the trial protocols along with any manuscript for publication so the editors can see the article accurately represents the study conducted.
Pfizer didn’t return calls for comment.
The editors created the policy after some drug companies were accused of stifling negative data from clinical trials. Last year, New York state Attorney General Eliot Spitzer sued GlaxoSmithKline for suppressing unfavorable studies of its antidepressants. He also asked Forest Laboratories for information about studies of its antidepressants.
Meanwhile, trial lawyers have accused Merck of hiding negative information about Vioxx, the pain killer it withdrew from the market last year because a study showed it doubled patients risk of heart attack and strokes.
Zarin said first she looked at whether pharmaceutical companies were giving drugs a distinguishable name. She said a name is crucial because it allows editors, patients and doctors to track a medicine’s progress through the trial process.
“You need a name to search a data base,” said Zarin. “You wouldn’t know if you were missing something if the drug doesn’t have a name you can search.”
Indeed, the problem that has vexed editors is that they can’t readily find out if negative data exists when they are only given glowing manuscripts. The registry is supposed to give editors, doctors and patients a complete picture of a drug’s development but that would be difficult if a medicine can’t be tracked through its name.
Of the over 400 companies with trials listed on the registry, only 5 neglected to list specific names, often calling the products simply “investigational drug”, Zarin said.
Zarin said that 90 percent of the time Merck didn’t provide a name. Glaxo didn’t provide a name 53 percent of the time while Pfizer lacked a name 36 percent of the time. The other two companies were Eli Lilly & Co. and Bristol-Myers Squibb Co. but they lacked names less than 5 percent of the time.
Drazen said another problems with the information submitted by three companies included a failure to clearly outline the primary and secondary outcome measures of their studies. For example, a study should say that it is attempting to see if a drug can lower heart attacks over a year.
However, Zarin noted that most companies didn’t provide such data and that it wasn’t required by the NIH. Since October, there is space for companies to include such information, however.
Drazen said that Lilly and Abbott Laboratories are “90 percent in compliance” with what the editors are expecting. Zarin gave high marks to Novartis for the quality of its disclosures.
Drug companies are legally required to register trials dealing with serious or life-threatening diseases to the NIH site. But since the controversy over trials, companies have been listing various types of studies on the site. Some companies have also begun listing the trials on their own web sites.
Earlier this year, four major international pharmaceutical associations agreed that companies should provide submit information on their trials to a public registry. The U.S. association, the Pharmaceutical Research and Manufacturers of America, recommended its members list trials on the NIH site beginning in July.
The editors have given the companies until September 13, 2005 to register ongoing trials. It applies to new trials starting on or after July 1, 2005.
Drazen said that if the companies don’t comply, editors will refuse to publish their studies. He said that other medical journals had adopted the registry standards of the international committee so companies that don’t comply may find their choice of publication venues is limited. Drug companies often use studies published in medical journals in their marketing.
“We think they will want our stamp of approval,” Drazen said.
Pfizer Wants Bextra Which Causes Stevens Johnson Syndrome and Toxic Epidermal Necrolysis Back on Market
CHICAGO, May 16 (UPI) — Pfizer Inc. wants to put its second-generation COX-2 drug Bextra back on the market but lawyers for patients who contend they were harmed by the drug warn it was approved too hastily in the first place.
The pharmaceutical giant voluntarily suspended sales of the $1 billion-a-year anti-inflammatory painkiller April 7, one day after a 19-page Food and Drug Administration memo raised concerns of possible health risks of COX-2 inhibitors, the class of painkillers touted as being easier on the stomach lining than aspirin. Bextra, Pfizer’s second generation COX-2 after the success of Celebrex, was prescribed for treatment of arthritis, rheumatism and menstrual pain.
Pharmacists no longer are allowed to fill prescriptions for Bextra and people who think they have suffered harm by taking the drug are filing personal injury lawsuits.
Pfizer Chief Executive Officer Hank McKinnell hopes Bextra gets FDA re-approval for at least limited use. He told the Boston Globe FDA reviewers saw unpredictable skin reactions in Bextra users but had not seen “increased cardiovascular risk,” the problem seen with Merck’s Vioxx, which was pulled from the market last fall.
“Pfizer continues to believe that Bextra could be an important treatment option for certain patient populations. In the future, the company plans to discuss options with the FDA under which Bextra might be made available to those patients,” the company said in a statement released last week.
Should FDA reintroduce the drug, patients likely would have to sign consent forms before filling a prescription.
FDA placed its strongest black box safety warning for risk of cardiovascular events on Celebrex last month and recommended pulling Bextra after seeing at least seven reports of people dying from severe skin reactions.
Stevens Johnson Syndrome and Toxic Epidermal Necrolysis are the most severe skin rashes triggered by full-blown allergic reactions to NSAIDs and sulfonamides. Both diseases are rare and life-threatening. SJD causes skin to burn from the inside and TENS occurs when the damage covers more than 30 percent of the body.
FDA have said Bextra, Celebrex and Vioxx — and possibly all nonsteroidal anti-inflammatory drugs drugs — come with an increased risk of serious adverse cardiovascular events. Vioxx was shown to double the risk of heart attack and stroke among patients in a clinical study who took the medication for longer than 18 months.
A Dec. 23, 2004, public health advisory on NSAIDs warned long-term use of naproxen — sold as Aleve, Naprosyn and other trade names — “may also be associated with an increased cardiovascular risk.”
Pfizer said Bextra, however, does not have the same heart-related risk as Vioxx.
Two studies released in January suggested combining Bextra with aspirin could increase risk of blood clots leading to heart attack or stroke. FDA asked makers of all NSAIDs to revise labels to warn of potential cardiovascular events, as well as serious stomach ulcer bleeding.
A study involving 6,000 people in clinical trials presented at the American Heart Association’s annual conference in November found Bextra doubled risk of heart attack or stroke.
Bextra was marketed as a kind of non-sulfa Celebrex. Critics branded it a COX-2 “me-too” possibly rushed to market because of Vioxx’s popularity. Bextra sales increased 355 percent worldwide in a single year.
This was a drug that according to Pfizer’s own admission was not studied in any clinical trial over 12 months duration and they knew that there was a huge market for these drugs so that there would be a patient population taking these drugs. I think that they saw the incredible early success of Vioxx and they wanted a share of that.
May 27 (Bloomberg) — A Pennsylvania jury decided that two former users of Wyeth’s drugs taken as part of the fen-phen diet combination deserved $200 million in damages for heart problems caused by the medicine.
Jurors in state court in Philadelphia on May 24 found that Wyeth’s weight-loss medicine scarred Margie Paul’s and Elaine Karician’s hearts and that they were entitled to $100 million each in damages, Wyeth said in a statement. Jurors must still decide whether Wyeth is liable for the women’s damages.
Paul’s and Karician’s trial was the latest in Philadelphia to focus on claims concerning Wyeth’s now-withdrawn diet drugs. Over the past 10 months, other Philadelphia juries have rejected claims by former users or said individuals who once used the appetite suppressant deserved as much as $500,000.
“I think that Philadelphia juries are beginning to understand the significance of the damage these drugs have done to people’s hearts and are awarding appropriate damages,” said George Fleming, a lawyer who has represented former fen-phen users in Philadelphia cases. He didn’t represent Paul or Karician.
The phase of the case where jurors will determine whether Madison, New Jersey-based Wyeth is liable for the damages has been delayed until July 25, the company said in the statement.
“The damage awards are excessive and completely unsupported by the evidence and are inconsistent with other recent cases in Philadelphia,” said Lawrence V. Stein, a senior vice president and the company’s general counsel, in the statement.
While the jury returned the verdict May 24, the judge in the case sealed the finding. Steven J. Kherkher, one of Paul’s and Karician’s lawyers, couldn’t immediately be reached to comment.
Wyeth said that they were in settlement negotiations with Paul’s and Karician’s lawyers to resolve the cases as part of a global resolution of the law firms’ remaining inventory of fen- phen claims.
The verdict, which Wyeth said in court papers is “almost 100 times any prior” fen-phen verdict in Philadelphia, is likely to cause concern among investors in the company, said Jake Dollarhide, a money manager who invests in drug companies.
“It poses a huge risk to Wyeth and their long road back to recovery,” said Dollarhide, chief executive of Longbow Asset Management Co. in Tulsa, Oklahoma, in a telephone interview today. Longbow owns shares of Wyeth competitors including Pfizer Inc. and Johnson & Johnson.
“The fen-phen matter just won’t rest. It’s got to be concerning them a great deal,” Dollarhide added. “The issue resurfaces time and time again. The fen-phen matter has legs.”
Wyeth has been working to resolve the remainder of its fen- phen liability across the country. The company faces a trial of the first of more than 5,000 fen-phen claims filed in New Jersey starting May 31.
Wyeth said on Jan. 31 that it would add $4.5 billion to its reserve to cover legal liability in the so-called fen-phen cases, bringing to $21.1 billion the amount set aside to resolve the litigation. Wyeth incurred a $1.76 billion fourth-quarter loss due to the reserve increase.
Pondimin and Redux
Wyeth removed the diet drugs Pondimin and Redux from the market in 1997 after researchers linked them to heart and lung problems in some users. Those drugs were used with the generic phentermine in the fen-phen combination.
Wyeth spokesman Doug Petkus said he couldn’t comment on what specific drugs were involved in the case.
Doctors wrote more than 6 million prescriptions for the diet- pill combination, which included Wyeth’s Pondimin or Redux drugs and the generic drug phentermine, before the products were pulled off the market in 1997. The company withdrew the drugs from pharmacies after researchers linked them to heart problems and a fatal lung disease in some users.
The Philadelphia cases involve former fen-phen users who declined to participate in the company’s $3.75 billion class- action settlement and chose to go to trial separately.
The verdict is the seventh-largest jury award nationally so far this year, according to data compiled by Bloomberg.
The largest verdict in a fen-phen case was awarded last year in Texas, more than $1 billion to the family of a 41-year-old woman who died after being diagnosed with a fatal lung disease linked to the diet drugs.
The next largest fen-phen verdict in Philadelphia Common Pleas cases since July 2004 was a $5.5 million award to two Utah woman March 30. Jurors in that case ruled April 8 that the company wasn’t liable for paying that award.
In court papers filed today in connection with Paul’s and Karician’s cases, Wyeth’s lawyers argued that the verdict should be thrown out because the women’s lawyers improperly “inflamed” the jury.
The company said that jurors deliberated for less than 100 minutes before returning the $200 million award.
Shares of Wyeth, which have risen 22 percent over the last 12 months, rose 9 cents to $43.82 in New York Stock Exchange composite trading today. Wyeth released after the close of regular U.S. trading.
The cases are Paul v. Wyeth, No. 003723 and Karician v. Wyeth, 001224, in Philadelphia Court of Common Pleas