Celebrex class action lawsuit filed in Canada

Celebrex, the drug made by Pfizer, has become the subject of British Columbia (Canada) class action law suits, with victims claiming that Pfizer "knew or ought to have known" that the drug had disastrous side effects. It is important to point out that law firms in Canada have been far more active in bringing lawsuits against US drugmakers. One Canadian law firm has filed a class action lawsuit against Eli Lilly in the Prozac case ahead of the US law firms. A second firm has filed a class action lawsuit against Eli Lilly in the Zyprexa case.

CELEBREX is a non-steroidal, anti-inflammatory drug -- specifically a "COX-2 inhibitor" -- which is prescribed to relieve pain and swelling. Since its 1999 introduction in Canada, it has typically been used to treat arthritis, acute pain, acute migraine headaches and menstrual pain and discomfort. Celebrex is manufactured by Pfizer Inc. Celebrex has been under higher scrutiny since the worldwide recall of Vioxx in September, 2004 and repeated calls for recall of Celebrex and Bextra (another drug in the same family).

The suit was filed last week in the Supreme Court of British Columbia by the law firm of Poyner Baxter of North Vancouver, which works predominantly in the field of class action suits. These actions follow in the wake of last fall's Vioxx controversy (also the subject of a Poyner Baxter action on behalf of British Columbia victims). Merck and Company recalled Vioxx because of the significantly increased risk to patients of cardiovascular events, including strokes and heart attacks. This worldwide attention cast the spotlight on Pfizer's Celebrex, a drug prescribed for the same conditions for which Vioxx had been used. (Related article: Tens of thousands of plaintiffs in Vioxx class action lawsuits)

Subsequently, similar alarming information has come forward from both scientists and patients concerning Celebrex. The Poyner Baxter statement of claim says, in part, "Celebrex has been associated with an increased risk of serious adverse cardiovascular complications, including but not limited to, heart attack, stroke, angina pectoris, atrial fibrillation, bradycardia, hematoma, irregular heartbeat, palpitation, premature ventricular contraction, tachycardia, venous insufficiency, cerebrovascular accident, congestive heart failure, deep venous thrombosis, pulmonary embolism, transient ischemic attack, unstable angina, and occlusion." (Related article: Celebrex safety update)

Unlike Vioxx, which was recalled, Celebrex continues to be sold, although, in December, 2004, Health Canada revoked approval for the drug for certain conditions and advised patients who were on long term 400 mg. daily doses to look for alternate medications. (Related article: Celebrex recall demanded)

The Poyner Baxter action claims that Pfizer was aware of these concerns as early as 2000 but continued to vigorously promote the drug, emphasizing its positive attributes to both physicians and patients, and either failing to disclose or minimizing any negative side effects. (Related article: Pfizer warned by FDA about misleading Celebrex ads) The patient who is named in this class action proceeding was prescribed Celebrex to treat muscle cramps in his calves and feet during 2003. Less than a year later, the lawsuit claims, he suffered the amputation of a toe, gangrene of the lower leg and subsequent surgery to repair a blood vessel.

Under B.C.'s "Class Proceedings Act," a suit is brought in the name of one individual as "representative of a class." Each of these actions cites the case of one person, but if certified by the Supreme Court, they will represent and potentially benefit everyone in the province who has suffered the negative consequences of using Celebrex.

Other drug links:

Oxycontin class action lawsuits

Reminyl recall

Prozac recall

Nexium class action lawsuits

Zyprexa class action lawsuit filed in Canada

ZYPREXA has become the subject of British Columbia class action lawsuits, with victims claiming that Eli Lilly "knew or ought to have known" that this drug proposed to treat certain conditions, had disastrous side effects. It is important to point out that law firms in Canada have been far more active in bringing lawsuits against US drugmakers. One Canadian law firm has already filed a class action lawsuit against Eli Lilly in the Prozac case.

ZYPREXA, manufactured by Eli Lilly and Company, and distributed in Canada since 1996, is among a group of drugs called the "atypical antipsychotic drugs" prescribed for the treatment of certain disorders, including schizophrenia and bipolar disorder. It blocks the action of serotonin and dopamine, producing a tranquilizing and antipsychotic effect.

The Zyprexa action filed last week in British Columbia alleges a direct link between Zyprexa and diabetes. The Plaintiff, a resident of a home for mentally disabled people, alleges that his use of Zyprexa resulted in diabetes. Options available to this patient for the treatment of the original mental condition are now egregiously limited because of the Zyprexa-induced diabetes.

There were 6 million prescriptions for Zyprexa in Canada over the 12 months ending October 2003. Total sales in Canada were valued at $223 million in 2002 and over $4 billion worldwide in 2003. Zyprexa has been associated with an increased risk of developing diabetes, hyperglycemia, pancreatitis, ketoacidosis and other injuries. In an October 16, 2003 press release, Eli Lilly disclosed a Health Canada order directing it to include updated information on hyperglycemia and diabetes on the labels of their antipsychotics.

This statement of claim reads, in part, "Eli Lilly purposefully minimized and understated health hazards and risks associated with Zyprexa. Eli Lilly, through literature and oral statements, deceived potential users of Zyprexa and their physicians by relaying positive information, including testimonials from satisfied users and by manipulating statistics to suggest widespread acceptability, while downplaying the known adverse and serious health effects of the drug. Eli Lilly falsely and fraudulently withheld relevant information from potential users of Zyprexa."

"Once again we have more evidence of what is becoming epidemic, and that is the pharmaceutical industry's irresponsible promotional zeal, unashamedly downplaying or ignoring evidence that might be injurious to their marketing goals," said lawyer Jim Poyner. " (Related article: Vioxx patients were misled by Merck through deceptive advertising)

Under B.C.'s "Class Proceedings Act," a suit is brought in the name of one individual as "representative of a class." Each of these actions cites the case of one person, but if certified by the Supreme Court, they will represent and potentially benefit everyone in the province who has suffered the negative consequences of using Zyprexa.

Other drug recall links:

Vioxx/Celebrex/Bextra recall

Reminyl recall

Prozac recall

Nexium recall

Oxycontin class action lawsuit certification denied

Justice Stephen J. Maltese of the Supreme Court of the State of New York for Richmond County denied the plaintiffs' motion for class certification in Hurtado, et al. v. Purdue Pharma L.P., et al., a personal injury lawsuit claiming harm, including addiction, caused as a result of using OxyContin (oxycodone HCl controlled-release) Tablets. Purdue Pharma is the Stamford, Connecticut-based distributor of OxyContin.

In state and federal courts around the country, class certification in OxyContin-related litigation has now been denied in written opinions on 9 occasions. After nearly four years of litigation, no plaintiff has been able to sustain a class in any of the OxyContin cases.

Class action status enables a plaintiff to prosecute a lawsuit on behalf of a larger group of people alleged to be suffering similar damages as a result of misconduct attributed to the defendant in the litigation.

Justice Maltese ruled that the Hurtado plaintiffs had failed to meet the "commonality requirement" of class certification, stating, "[This case presents] important individual issues and to lump all of those issues together would be inappropriate for all of the parties involved." (Opinion, p. 9)

He observed specifically, "[W]without a common injury or 'signature disease' like asbestosis or mesothelioma, which only come from asbestos contact, it is difficult to define a class or establish causation. Signature diseases are those that are uniquely related to exposure to a certain substance and are rarely observed in individuals that are not exposed. If the plaintiffs proffer that addiction is a common injury to all parties, that does not substantiate their case. The Court of Appeals in New York has determined that issues of addiction are individualized and are not appropriate for class certification." (Opinion, p. 9-10) (Related article: Bush proposes a ban on mesothelioma/asbestos class action lawsuits)

In his 23-page opinion and order, Justice Maltese also reviewed the reasoning and holdings of the state and federal courts that previously had ruled on the issue of class certification in OxyContin litigation. He noted that the New York state trial court over which he presides is not bound by the decisions from these other jurisdictions, but expressed reluctance "to rule on a case of such magnitude, which could affect potentially thousands of people without knowing what other courts have done under similar circumstances, which may be persuasive." (Opinion, p. 20).

"Justice Maltese's opinion is very welcome and we appreciate and respect his analysis," stated Howard R. Udell, Executive Vice President and Chief Legal Officer of Purdue Pharma. "This is yet another in a series of rulings in our favor that are not only important in our litigation, but for patients as well."

In OxyContin cases that have ended, 261 lawsuits against Purdue Pharma have either been dismissed by the court or withdrawn by the plaintiffs. No case has resulted in a verdict against Purdue Pharma. With the exception of a single lawsuit brought by the Attorney General of West Virginia that was settled with no admission of wrongdoing by the company, Purdue Pharma has paid nothing to settle any of the 261 private cases that have been withdrawn or dismissed.

Related articles about other drug recalls:

Vioxx/Celebrex/Bextra recall

Reminyl recall

Prozac recall

Nexium recall

Prozac missing document drama ends

The drama about missing documents related to adverse side effects of Prozac, that also led to speculation that a Prozac recall might happen, may about to end. To recapitulate, the British Medical Journal reported that US Food and Drug Administration (FDA) was to review confidential Eli Lilly documents that had been sent to the BMJ by an anonymous source. The article stated that these documents had gone "missing" during a 1994 product liability suit filed against Eli Lilly. (Related article: Harvard scientist claims that Prozac has adverse side effects like suicidal behavior)

As soon as the news broke, there was intense speculation about what Eli Lilly knew and what it did not disclose. Eli Lilly subsequently denied that it hid any information in a lawsuit in the UK. (Related article: Prozac contoversy gets interesting) This led to an investigation by the Journal that revealed that all of the documents supplied to the BMJ that were either Eli Lilly documents or were in the hands of Eli Lilly had in fact been disclosed during the suit. At the end of the trial, all the documents were preserved by Court Order or were disclosed by Eli Lilly to the plaintiffs' lawyers in related Prozac claims. (Related article: Eli Lilly claims that Prozac is a safe drug)

In a statement released by the Journal, it said, "The BMJ did not intend to suggest that Eli Lilly caused these documents to go missing. As a result of the investigation, it is clear that these documents did not go missing. The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims. The BMJ is happy to set the record straight and to apologise to Eli Lilly for this statement, which we now retract, but which we published in good faith."

This has, however, not ended the drama in the legal world. A Prozac class action lawsuit has been filed in Canada.

Other drug recall links:

Vioxx recall

Celebrex recall

Bextra recall

Reminyl recall

Nexium recall

Nexium class action lawsuits filed

Massachusetts consumers of the heartburn medication Nexium have filed a statewide class action lawsuit in Massachusetts Superior Court against the drug's distributor, AstraZeneca. The suit alleges that the pharmaceutical company sought to preserve their market share and profits as the patent on their blockbuster drug, Prilosec, was set to expire, by initiating a massive and misleading advertising and promotional campaign to deceive consumers into purchasing Nexium, a nearly identical new drug.

This issue has gained prominence since the recall of Vioxx by Merck. Experts have argued that Merck aggressively advertised Vioxx to consumers who were unlikely to benefit from it. Merck is facing hundreds of class action lawsuits related to Vioxx. Pfizer, the maker of Celebrex and Bextra, two other drugs like Vioxx, has also been warned by FDA about misleading ads and consumers have filed dozens of class action lawsuits against Pfizer.

“The Nexium campaign is a perfect example of a ‘me-too' drug being falsely marketed as a medical improvement. Adding yellow stripes to the Purple Pill only improves AstraZeneca's bottom line, not consumers' health,” said Alex Sugerman-Brozan , Director of Community Catalyst's Prescription Access Litigation Project (PAL)

“AstraZeneca's Nexium promotional campaign has resulted in billions of dollars of unnecessary drug expenditures at a time when rising drug prices have created a health care crisis in this country. As a result, hundreds of thousands of patients take Nexium when they don't need to or when more affordable substitutes are readily available,” said John McDonough , Director of Health Care For All, which is a plaintiff in the lawsuit.

“As part of its strategy to switch patients from Prilosec to nearly identical Nexium, most of AZ's clinical studies compared 40mg of Nexium to 20 mg of Prilosec. In addition, according to a 2002 article in the Wall Street Journal , AZ ‘won't release detailed descriptions' of two studies that showed even the higher dose of Nexium to be no more effective than Prilosec,” explained John Abramson, M.D., author of Overdosed America: The Broken Promise of American Medicine. “Evidence-based medical care is not necessarily the best care when the scientific evidence is designed to optimize commercial benefit instead of health. In the case of Nexium, doctors and patients have been misled into believing that Nexium, which costs up to 7 times as much, is superior to over-the-counter Prilosec.”

Prilosec (also known as Losec) is a proton-pump inhibitor (PPI) primarily used to treat Gastroesophageal Reflux Disease (GERD) and was AstraZeneca's most profitable drug. By 2000, Prilosec was the most prescribed drug in the world, with annual global sales reaching $6 billion. But with Prilosec's patent set to expire in 2001, its loss of brand name protection and assured competition from generic drug manufacturers posed a financial vulnerability to the pharmaceutical company.

The lawsuit alleges that AstraZeneca responded to this financial threat by launching a massive advertising campaign to overshadow the perceived effectiveness of Prilosec, and persuade consumers that Nexium was a new and improved PPI.

“As a consumer, I'm outraged that a company supposedly in the business of helping people would put its profits ahead of my health and well-being,” said Glenn Crenshaw, who took Nexium and who is a plaintiff in the lawsuit. “Tricking consumers into switching to a drug that's much more expensive has caused millions of people fiscal heartburn and shows that the system is in real need of change.”

“We feel that AstraZeneca is misleading the public through expensive marketing campaigns that don't tell the whole story about Nexium and Prilosec, in order to increase its sales,” said Bob Master, Director of Commonwealth Care Alliance. “Schemes like this add to the runaway cost of health care and every dollar spent unnecessarily on expensive new drugs of dubious added value is a dollar less available for real patient care.”

The suit is brought by Health Care For All, Commonwealth Care Alliance, and individual consumers, on behalf of Massachusetts residents who purchased Nexium. Both organizations are members of the Prescription Access Litigation Project (PAL), a national coalition of over 100 consumer organizations dedicated to fighting illegal pharmaceutical price inflation through class-action lawsuits.

The lawsuit claims that AstraZeneca is violating the Massachusetts Consumer Protection Act, Chapter 93A. That law prohibits “unfair methods of competition and unfair or deceptive acts or practices” by businesses. The lawsuit alleges that by deceiving the public about the value and effectiveness of Nexium through a multi-million advertising campaign, AstraZeneca has illegally deceived Massachusetts consumers and caused them to pay a premium price for Nexium as a result of that advertising.

Another suit has been brought by the American Federation of Labor - Congress of Industrial Organizations (AFL-CIO), the Congress of California Seniors, andthe California Alliance for Retired Americans, on behalf of consumers nationwide who purchased Nexium.

Other drug recall links:

Bextra recall

Celebrex recall

Prozac recall

Is Reminyl recall likely?

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., announced that health authorities are reviewing scientific data from two clinical trials evaluating an investigational use of the company's Alzheimer's treatment, REMINYL (galantamine hydrobromide), in individuals with mild cognitive impairment. REMINYL is a registered trademark of Johnson & Johnson.

REMINYL is an acetylcholinesterase inhibitor currently approved in 69 countries worldwide for treatment of mild to moderate Alzheimer's disease. No regulatory applications have been submitted for the potential use of REMINYL for the treatment of mild cognitive impairment anywhere in the world, nor are any planned.

The review was initiated as a result of a preliminary safety assessment of an imbalance of mortality in two mild cognitive impairment clinical trials submitted to health authorities worldwide by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., in August 2004. The clinical trial results also were presented last year at two international scientific forums: the International Congress of Alzheimer's Disease (ICAD) and the Alzheimer's Association Research Roundtable Mild Cognitive Impairment Meeting.

Approximately 2,000 patients from 16 countries were enrolled in the GAL-INT-11 and GAL-INT-18 studies, which were designed to evaluate a potential decrease in the rate of progression from mild cognitive impairment to dementia in subjects treated with the drug.

Mortality rates were low in both the REMINYL and placebo groups in this two-year study compared to expected rates in this population or in patients with Alzheimer's disease. The clinical trials showed a higher relative mortality rate in patients with mild cognitive impairment treated with REMINYL than in patients treated with placebo. In the studies, 20 deaths due to various causes were reported during the double-blind portion of the two pivotal studies, with 15 occurring in subjects randomized to galantamine and five occurring in patients receiving placebo. The overall incidence of serious adverse events was not different between the group treated with REMINYL and the placebo-treated group.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is currently analyzing additional data from these studies, including information retrieved from subjects who had dropped out of the trials, and is discussing the results with regulatory authorities.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C., developed REMINYL under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. Janssen Pharmaceutica Products, L.P., manufactures and markets REMINYL in the U.S.

REMINYL is approved to treat patients with mild to moderate dementia of Alzheimer's. The most frequent adverse events are nausea, vomiting, diarrhea, anorexia and weight loss. They are usually mild and temporary.

Related links:

Vioxx recall

Celebrex recall

Bextra recall

Prozac recall

Prozac class action lawsuit filed

A Prozac class action lawsuit was filed before the Superior Court in Montreal on January 14. Giant drug maker Eli Lilly is alleged to have withheld vital information on the safety of Prozac, its flagship drug for years. Yesterday, the Indianapolis based drug maker completely vindicated the British Medical Journal, which it had charged earlier this week with misleading its readers, when it posted a document on its website called Annotations. Eli Lilly had been invited on numerous occasions to answer whether a document called Summary of a preliminary analysis of clusters of adverse events based on pooling data from multiplestudies was authentic and whether it had been released to health authorities around the world. (Related article: Is Prozac recall next?)

Eli Lilly confirmed the authenticity of the document and implicitly admitted that it had never been released to health authorities, including the FDA, or anyone else. The document consisted of data stemming from numerous studies conducted by Eli Lilly and that showed that Prozac caused activation in 38% of its users compared with 19% with placebo and 4% for Tricyclic, a then well known drug in the treatment of depression.

When Eli Lilly representatives attended the FDA hearings on the safety of Prozac in 1991, they had known the existence of the study for years but failedto disclose it to the FDA, in the word of the lead plaintiff's attorney, "lest it should warrant a much stringent warning on the label of the drug withregard to its safety, thereby seriously hampering Eli Lilly's efforts to market its new drug as effective and safe." In the words of Serge Petit of thelaw firm Petit Desjardins based in Montreal, Canada, that represents the lead plaintiff "such a likelihood was looming large since Eli Lilly knew that ifdoctors had been made aware that Prozac, back then being introduced as the new kid on the block, caused activation in 38% of its users compared with 19% ofpatients taking a placebo and 4% of those taking a drug then well known to doctors, Tricyclic, they would certainly have hesitated before prescribingProzac. It was nearly a ten folds increase in activation compared with the other drug they could prescribe."

The lead plaintiff contends that the reason why Eli Lilly failed to disclose the document to Health authorities was that it would have placed another study, that consisted of a pooling of what is called spontaneous reports and showed alarming increases in suicide attempts and other violent acts in patient using Prozac as compared with four other drugs, in a totally new perspective and prevent it from being dismissed by FDA and Eli Lilly as inconclusive. To Serge Petit "had the study on activation and the one on spontaneous reports been put side by side before the FDA, Eli Lilly would have faced an uphill battle as to the safety of its drug".

The class action contends that Eli Lilly misled health authorities around the world and therefore the millions of users of its drug Prozac around theworld as to the safety of its drug by failing to disclose the said document. To Serge Petit, "the passage of time cannot condone Eli Lilly's behavior andit must be held accountable for circumventing the safeguards that have been put in place to protect the public health." The lead plaintiff is seeking $10,000 in punitive damages and $5 000 for herself and each member of the group from Eli Lilly for misrepresenting the safety of its drug.

Related links: Celebrex recall Vioxx recall Bextra recall

Together Rx Access Card - features and benefits

In coming weeks you will hear a lot about the Together Rx Access Card, particularly if you do not have health insurance coverage. Together Rx Access is a free savings program that helps qualified individuals and families save approximately 25%-40% and sometimes more on over 275 brand-name prescription drugs and other prescription products, as well as a wide range of generic drugs.

The Together Rx Access Card is unique because it will allow approximately 36 million uninsured patients – 80 percent of the total uninsured population – to access the broadest range of safe prescription medicines (brand-name and generics) and products at meaningful savings through a free, easy-to-use card. Together Rx Access also can help direct individuals to various additional resources, including companies’ existing Patient Assistance Programs, for help obtaining coverage or products.

The Together Rx Access Card is available to Americans with no coverage for prescription products. To be eligible for the Card, applicants must:Not be eligible for MedicareHave no public or private prescription drug coverageHave incomes of 300 percent FPL or below [$30,000 for a single person and$60,000 for a family of four Be a legal U.S. resident

A majority of pharmacies nationwide and in Puerto Rico will accept the Together Rx Access Card and 100 percent of the savings being offered by the participating companies will be provided to the consumer at the pharmacy counter. Simply take your card to a participating pharmacy along with your prescription, and your savings will be calculated at the pharmacy counter for both prescription and generic drugs.

There are no enrollment fees, no monthly fees, and no hidden fees. If you think it is too good to be true, there is a reason why these companies want your business. They are hoping that when you have a card that saves you money you will be motivated to see a doctor and buy medicines which you would not do without a card. So they are essentially trying to attract new customers and giving you a discount to keep your business. Plus, it makes these companies and the Federal government look good - they want to claim that they are doing something for the poor and the needy.

Is this card for you?

• Check your eligibility first. If you do not meet the eligibility criteria, you are out of luck. This card is not for everyone because higher-income individuals and families are excluded.
• Not all drugs are available. About 275 drugs are covered at this time.

Lilly claims that Prozac is a safe drug

Eli Lilly and Company announced its plans to correct inaccurate statements circulating in the news media based on a collection of random papers anonymously sent to the British Medical Journal (BMJ).

The British Medical Journal (BMJ) published an article in its Jan. 1, 2005, issue stating that the FDA has agreed to review confidential Lilly documents that suggest a link between Prozac and suicide attempts and violence. The journal alleged that the documents, given to the BMJ from an anonymous source, went missing during the case of Joseph Wesbecker in 1994. (Related article: Prozac recall expected after emergence of disturbing evidence)

The journal provided 52 pages of documents to Rep. Maurice Hinchey (D-NY), who forwarded them to Lilly on Tuesday, Jan. 4. On Wednesday, Jan. 5, Rep. Hinchey sent a letter to Dr. Lester Crawford, acting commissioner of the FDA, calling for an investigation into this matter. After reviewing the documents, Lilly issued a response on Jan. 4 stating that they reveal no new clinical or scientific information. Lilly emphasized that the information has already been shared with the FDA, published in medical journals or used at various legal trials for more than a decade. (Related article: Lilly denies anything new in Prozac documents)

Lilly has reviewed the documents, which are a collection of various single pages and groupings in no particular order, and created an extensive annotation. Due to court orders requiring confidentiality of some of the documents contained within the 52 pages, Lilly is unable to release the 52 pages of documents.

"While it is important that we correct false assertions about how Lilly manages its data, it is even more important to set the record straight for patients who rely on our medicines for their daily well-being," said Sidney Taurel, chairman, president and chief executive officer. "It is simply wrong to suggest that information on Prozac was ever missing or that important research data on the benefits and possible side effects of the drug were not available to doctors and regulators," said Taurel.

In Lilly's open letter to the public, Taurel states: "At Lilly, we're concerned that the BMJ story, and misleading reports about it in other media, have needlessly spread fear among patients who take Prozac. But the best thing that we can do is to seize this as an opportunity to improve everyone's access to information about Prozac - one of the most widely studied therapies in the entire history of medicine."

The article published by the BMJ and subsequent articles from various media contain false allegations regarding disclosure about important Prozac safety information as well as misleading and scientifically invalid conclusions about Prozac data.

"Lilly has always been forthcoming with safety data. This particular information has been shared with regulators and publicly discussed by experts, with conclusions supporting Prozac's safety," said Alan Breier, M.D., vice president and chief medical officer, Eli Lilly and Company. "We are confident that there is more known about Prozac after two decades of rigorous study than any other comparable medication," he added.

Erroneous conclusions drawn from tables comprised of spontaneous adverse event data (a reporting system for a particular drug comprised of adverse events occurring in people taking the drug) in the documents obtained by BMJ are at the heart of the data misrepresentations and reflect the fundamental problem of the BMJ reporting on statistical information without providing scientific context. Specifically, the media reports stating that Prozac is 12 times more likely to cause suicide than other, older antidepressants is patently false and not supported by clinical trial data.

"A worrisome outcome from these inaccurate reports would be for patients who are stable on medication to stop treatment unnecessarily, which has the potential of undoing clinical progress and setting back patients in their illness," said Doctor Breier.

Among the documents provided to BMJ are charts created by a hired expert for plaintiffs' attorneys, whose own admission in legal testimony concluded that the data contained in these charts do not show that Prozac causes suicidality or violence. These very data were initially presented by the FDA to evaluate the safety of Prozac in 1991 to an advisory committee comprised of external experts. The FDA advisory committee voted unanimously in support of Prozac's safety.

Spontaneous adverse event reports have been the subject of significant research in the scientific community, and it is widely agreed that only controlled clinical trials can achieve valid comparisons between medications. Drawing conclusions about causality from spontaneous adverse event reports is invalid, given several important limitations. The limitations include the nature of voluntary reporting, variables such as other drugs a patient may be taking and duplicate reporting of the same adverse event from more than one source (e.g., pharmaceutical company, patient, physician, and pharmacist). Reports on suicide attempts and suicidal ideation, in particular, are problematic because each case represents an individual with varying degrees of illness, treatment and support, making it difficult to understand the nature of the event.
Prozac has helped to significantly improve millions of lives and it has been prescribed for more than 54 million people worldwide.

To demonstrate Lilly's transparency, the company is in the process of talking to all parties - the FDA, Congressman Hinchey, and the BMJ, in an effort to resolve the situation. Lilly is committed at the highest level to ensuring that all parties, and most importantly, our customers, are satisfied with those answers. Additionally, Lilly is calling on the BMJ to make the full documents available to media and other interested parties. Lilly obtained the documents from the office of Congressman Maurice Hinchey (D-NY).

Recommended article: Harvard expert claims that Prozac may have adverse side effects

Source: Eli Lilly

Agreement difficult to ban asbestos lawsuits

The US Senate, at the behest of President Bush who has proposed banning asbestos class action lawsuits and creation of a trust fund, is currently discussing a bill “The Fairness In Asbestos Injury Resolution Act”. Senator Arlen Specter is following the guidelines provided by Bush and is holding hearings on the bill, that is largely opposed by most mesothelioma victims and their attorneys, who are afraid that adequate compensation will not be available to those that have suffered the most. (Related article: Bush proposes ban on asbestos class action lawsuits)

Senator Patrick Leahy has issued a statement that explains his position on the matter. He says, "We must see our efforts through until we have a balanced and effective national trust fund that fairly compensates victims of asbestos-related disease. In order to reach that goal, we must continue to work with the various stakeholders and Senators on both sides of the aisle until we settle the outstanding details on a fair resolution for all concerned...We have yet to reach consensus on the other two pillars of a successful trust fund -- fair award values for asbestos victims, and adequate funding to pay for the victims’ claims. If the award values are too low or subject to liens that reduce or exhaust any recovery for victims, the bill will be inherently unfair and unworthy of our support. There are about 600,000 legal cases currently pending in the system, making it critical to have adequate funding at the inception of a national trust fund. Direct contributions from defendants and insurers and borrowing authority will be necessary to accommodate the inevitable, which is thousands of these pending claims coming in on the very first day of the trust fund." (Related article: Asbstos Injury Resolution Act faces strong opposition from mesothelioma patients)

Reaching agreement on this complex issue is not going to be easy. There is already strong opposition from several mesothelioma victims rights groups. AFL-CIO President John J. Sweeney, speaking for workers suffering from mesothelioma, said, "President Bush missed an opportunity today to show genuine compassion for the victims of asbestos disease and support for responsible relief for businesses struggling with asbestos claims by failing to endorse the creation of a national asbestos victims trust fund. Contrary to comments at today’s White House event, the crisis we are facing is not just a litigation crisis, it’s a disease crisis. For the last several decades we have seen the toll of workers and family members disabled and killed by asbestos disease mount to staggering levels, the result of the willful practices of manufacturers and employers who withheld information about the hazards of asbestos and did little or nothing to control exposures." He further proposed that an adequately funded no fault system was the best way to make sure that asbestos victims would be fairly compensated.

Related article: Senator Specter's plan opposed by mesothelioma victims

Bush proposes a ban on asbestos class action lawsuits

After his reelection, President Bush has embarked on an aggressive program to change the legal system of the United States, specifically laws related to class action lawsuits. In summary, the initiatives being proposed using the buzzword "tort reform" will essentially deprive Americans the right to sue a company when it makes a killer product. Some of the companies that will benefit immediately are the makers of asbestos and drugs like Vioxx.

The President stressed the need for class action lawsuit reform, in general, and asbestos litigation reform in particular, and he urged Congress to enact proposed reforms early this month. He says, "The growing problem of asbestos litigation is similarly hurting workers, bankrupting businesses, and delaying relief for the truly sick claimants." President Bush supports enactment of medical liability reform, class action lawsuit reform, and asbestos litigation reform to expedite resolutions and curb the costs of lawsuits for all Americans. Most experts do not expect that all of these can be achieved but many have expressed fears that some laws could be changed since all branches of government are now controlled by one party. But most mesothelioma victims oppose the President's ideas since they believe they are designed to help the companies, rather than the victims of mesothelioma. (Related article: Mesothelioma victims oppose plan to ban asbestos lawsuits)

The President does not want to appear as if he does not appreciate the sufferings of those who have been injured by asbestos or whose family members have died. He says that, "Victims of asbestos-related diseases deserve a fair system and a long-term solution. The current system may leave little or no funds to pay current and future asbestos victims; is costly to administer (future transaction costs are estimated at between $145 and $210 billion); will impose large, indirect costs on the economy; and has driven exposed defendants, including small businesses, into bankruptcy. Asbestos, as the longest-running mass tort litigation in U.S. history, has led to the bankruptcies of at least 74 companies. Within the past few years, there have been sharp increases in the number of asbestos claims filed annually. The President has stressed the need for reform and commended Congress for aggressively working on this problem, but more work needs to be done to pass legislation for the President to sign that provides a fair and permanent solution."

Recommended article: The Fairness in Asbestos Injury Resolution Act opposed by mesothelioma victims

Mesothelioma victims group opposes Specter plan

A mesothelioma victims group expressed concern today that it would be impossible to design and implement a national asbestos trust fund in a way that provides the needed protections for persons exposed to asbestos. The group is responding to efforts by Senator Arlen Specter and others who want to ban asbestos class action lawsuits and strike a deal with all parties involved by creating a fund to compensate victims.

The Committee to Protect Mesothelioma Victims (CPMV), which was formed shortly after Sen. Orrin Hatch (R-Utah) effectively ended negotiation with organized labor and others earlier this year by announcing his plan to remove asbestos litigation from the nation's court system, now believes that the better option for victims is a medical criteria/registry approach. While individual program details differ, medical criteria/registry approaches require those seeking to sue for asbestos injury to first be screened under medical criteria determined by a third party. In this case, Congress has already agreed to a set of criteria. Those not meeting the qualifying threshold established by the criteria do not lose their legal right, but instead their right is preserved should their condition advance to a higher criteria level.

Although the medical criteria/registry bill requires individuals to meet qualifying standards to get into court, the Committee favors the idea because it preserves individuals' rights to have their day in court. However, it is a policy generally favored by the business community because it has the ability to heavily reduce the volume of litigation. Experts have estimated that the medical criteria/registry approach can reduce asbestos court cases by 90 percent.

The medical criteria/registry approach has become the most popular solution to the asbestos problem on the state level having been adopted in a number of states including Ohio, West Virginia and New York. Mesothelioma is one of the more deadly asbestos-related cancers, attacking the lining of the lungs and typically resulting in death within a year of diagnosis. Committee spokesperson Sue Vento, the widow of U.S. Rep. Bruce Vento, who died of mesothelioma in 2000 after 24 years in Congress, said the medical criteria/registry approach offers more protection for both current and future victims of asbestos then the "trust fund." Vento said she favors the system over the trust fund because it protects victims' rights while addressing the central concern of the business community: the high volume of asbestos cases. "And I want to personally thank Billie Speicher for putting a face on this awful disease and the need for extensive research for a cure. I also agree wholeheartedly with him when he states, like all victims, he doesn't want to lose his right to have his day in court.

"If Congress is going to act at all," continued Vento, "We prefer the medical criteria/registry approach over the trust fund because we don't trust a new huge federal bureaucracy to help the very sick, we don't trust that it will protect victims rights, and we certainly can't trust that the fund will have enough money … because asbestos is not banned in this country, and who knows how much liability will eventually exist?"

Recommended link: Complete news and updates on Mesothelioma fund creation

Asbestos Injury Resolution Act opposed by mesothelioma victims

The Asbestos Disease Awareness Organization (ADAO), an organization dedicated to serving as the voice of asbestos victims, today announced its opposition to "The Fairness in Asbestos Injury Resolution Act" - sponsored by Senator Arlen Specter (R-PA).

In a written statement submitted today to the Senate Judiciary Committee, which held hearings to discuss the bill, ADAO Executive Director Linda Reinstein stated:

"As President Bush mentioned, 'The volume of asbestos lawsuits is beyond the capacity of our courts to handle, and it is growing. More than 100,000 new asbestos claims were filed last year alone.' But we need a solution that takes into account the voice of the victims and puts their rights first.

• Asbestos is a public-health crisis not a bankruptcy crisis.
• The U.S. alone loses 30 lives every single day, and the numbers are estimated to be five times higher if victims were diagnosed correctly.
• Asbestos exposure is responsible for one in every 125 deaths of men over the age of 50.
• Asbestos has not been banned in the United States.
• Asbestos is the largest single cause of occupational cancer in the United States.

Presently, ADAO is opposed to the bill for the following reasons.

• Our Medical Advisory Board strongly objects to the outdated and incorrect medical criteria in this bill describing the symptoms, diagnosis and severity of asbestos related diseases. Any piece of legislation should follow the established American Thoracic Society guidelines to diagnose and treat asbestos related diseases.
• Inordinate compensation delays and ineligibility for the victims.
• Inadequate funding for not only research, but education, prevention and outreach."

Reinstein also criticized the proposed trust fund in the legislation, explaining that: "Asbestos diseases can take twice as long to appear as the fund is designed to last. That leaves millions of Americans exposed to asbestos with a fund that is destined to become insolvent...Once again, sick and dying victims will be at the mercy of bureaucracy and receive more aggravation than compensation...We are not principally opposed to a trust fund. But it makes good business sense to design a fair and balanced fund that provides speedy compensation and adequate funding for research, education and outreach. Give the victims the right to choose the fund or a trial. Citizens need to make certain before they give up their right to a trial, that a national trust fund has sufficient funding for the future."

Reinstein, whose husband is undergoing treatment for mesothelioma, concluded by saying: "For many of us, it's too late, but it's not too late for Congress to write fair and just legislation for the victims of today and the future."

Recommended link: Complete coverage of Mesothelioma and other asbestos related lawsuits

Fondue party and recipe ideas for couples

There are many ways to get ready for the Valentine's Day but how about a fondue party for a couple or with a few friends. Finding recipes for fondues is easy but here are a few that folks at MYNIPPON like:

Classic cheese fondue recipe

Asian flavor fondue recipe

Mexican fondue recipe

Chocolate fondue recipe

Cooking recipes from Africa

Imfwama Wotela has submitted two excellent recipes from Africa but it seems that almost everyone will find them to be delicious - they are universal in taste.

Pumpkin fritters recipe

Groundnuts sweets/candies recipe

How to file income taxes online?

If you have never filed your taxes online and are scared of getting online or on a computer to do your own taxes, then you might want to read our lifestyle expert's simple guide on how to file your income taxes using a tax software. If you can check your email and read numbers from your W-2 and bank statements, you can do it and save a ton of money in the process.

DNA testing procedure for Vioxx victims

A commonly asked question by those people who took either Vioxx, Celebrex, or Bextra is that how do they know if they have been hurt. Sometimes there are no obvious symptoms but the damage can be enormous. In many cases, your doctor can answer this question and it is best to work with a Vioxx attorney to determine the next step. It is very important to find out if you have been hurt and to what extent to determine if it makes sense to file a lawsuit against Merck of Pfizer.

Now a Seattle-based company, Genelex, may have the solution for this problem using DNA testing. Working with knowledge gleaned from human genome mapping, Genelex has developed consumer-friendly, personal DNA tests, giving physicians, pharmacists and patients the knowledge they need about the way hundreds of prescription, over-the-counter and herbal medicines are individually processed.

More than half of all people have variations detectable by DNA testing that affect the safety and efficacy of these drugs including anti-depressants, anti-inflammatory, pain, and many heart and allergy medications among others. For example, Celebrex is a member of the COX2 inhibitor class of drugs which includes Vioxx and Bextra. The first and most important step in the processing of Celebrex is deficient in five to ten percent of the population. When individuals with this decreased drug processing capacity take Celebrex, the drug levels elevate to abnormal levels in their blood stream. The elevated levels could significantly increase the risk of strokes and heart attack. According to the company, "Patients with the genetically programmed deficiency in Celebrex processing can be identified by simply taking Drug Reaction DNA tests for an enzyme called CYP2C9. These DNA tests have great potential to reduce major medical problems associated with gene-based poor metabolism of prescription drugs."

Pharmaceutical companies currently perform genetic testing during drug development and in clinical trials. With minor exception, however, they have not recommended, nor has the FDA required, that genetic testing be done prior to the drug being prescribed or administered. Drug Reaction DNA Testing kits developed by Genelex Corporation are available via their website without prescription. Consumers receive their results by mail and are urged to share the findings with their physicians and pharmacists. Patients may also obtain a personalized report based on the medicines they are currently taking.

Recommended article: What to do if you took Vioxx but do not have any visible side effects?

What is the right age for plastic surgery?

Isn't it a good idea to have it as soon as you can, particularly if you can afford it? Maybe not, doctors say. While plastic surgery produces mostly physical changes, it also has significant emotional implications and if you are not ready to deal with those, you should wait till you are fully mature. So read more about what is the right age for plastic surgery in our latest article and what it means when young people have plastic surgery.

Prozac may have adverse side effects

The drama of a likely Prozac recall gets interesting each day. First of all, the papers that established a link between Prozac and suicidal behavior disappeared, and reappeared, were then declared as nothing new by Eli Lilly.

Now Harvard psychiatrist is charging in a USA Today interview that Americans were treated as guinea pigs by Eli Lilly. Sounds like how Merck has treated Americans in the Vioxx recall case.
Dr. David Graham, associate director in the FDA's Office of Drug Safety, and a hero for exposing the mess in the