Almost an Iressa recall announced by FDA

After dragging its feet for months, the FDA has finally acted on the cancer drug Iressa (gefitinib) manufactured by AstraZeneca. Iressa was approved using the accelerated approval process and when subsequent studies showed that it was only as good as a placebo, there have been several calls from consumer rights groups for recalling Iressa. In a recent study, the US House of Representatives cited Iressa as a classic example to show that the accelerated drug approval process is totally broken.

While FDA has not announced a recall of Iressa (that is not surprising considering that FDA has failed to recall other drugs that should not be on the market, for instance, Adderall, Crestor, Nexium, Prozac, Viagra, etc.) but the new label will essentially show that drug should be used only for those cancer patients who, in the opinion of their treating physician, are currently benefiting, or have previously benefited, from gefitinib (Iressa) treatment. In addition to the new labeling, FDA has agreed to AstraZeneca's proposal to limit distribution of this drug under a risk management plan called the Iressa Access Program.

The FDA added that new patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer. FDA has approved Taxotere (docetaxel) and Tarceva (erlotinib), both of which have been shown in studies to improve survival in patients with non-small cell lung cancer whose cancer has progressed while on previous therapies. Alimta (pemetrexed) has received an accelerated approval based on the surrogate endpoint for this use but has not yet demonstrated any survival benefit.The FDA confirms that while this is not a recall, the agency may recall it later after reviewing the data.

FDA approved Iressa in May 2003, under the Agency's accelerated approval (Subpart H) program, for the treatment of patients with non-small cell lung cancer who had failed two or more courses of chemotherapy. Iressa is currently approved in 36 countries.

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Natrecor prescription guidelines to be revised

Natrecor, the popular drug given to heart patients, continues to face criticism from experts. Now according to Scios (a division of Johnson & Johnson), an independent panel of experts says that Natrecor should be restricted and only used with acutely ill hospitalized patients. They want Johnson & Johnson to conduct a more comprehensive clinical trial, as available data indicates that Natrecor may increase the risk of kidney problems and death. (Related article: Natrecor increases risk of death)

Natrecor is the latest drug to raise safety concerns long after receiving Food & Drug Administration approval. Currently Viagra is another drug that is facing a recall possibility apart from other approved drugs that have come under a cloud about their safety after they were on the market for years. Vioxx and Bextra have been recalled while Celebrex received a black box warning. Other NSAIDs, and more specifically Ibuprofen and Diclofenac, have also been found to increase risks of heart attacks after being approved by the FDA and being available for years.

The panel, which was convened by Dr. Braunwald at the request of Scios, also provided guidance and counsel on the ongoing and planned clinical development program for the product as well as recommendations for use. The panel said Natrecor should not be used routinely for heart-failure patients even though there are few similar drugs, until more research is done. It is suprising to know that many doctors prescribe Natrecor without thinking much about it. Not too long ago, the Cleveland Clinic had almost recommended a complete ban on use of Natrecor but decided to only put restrictions on its prescription.

According to a written statement, J&J has accepted the panel's recommendations, and are planning a clinical study. The panel recommend that the drug should be reserved for hospitalized heart-failure patients who have trouble breathing at rest and not outpatients who have breathing problems after mild exertion. Scios noted that the panel recommended a use for NATRECOR that is slightly narrower than what is outlined in its approved label. The company is contacting regulatory agencies to discuss how to best address this recommendation. “The panel also described uses for which it believes NATRECOR is inappropriate,” said Dr. Darlene Horton. “Scios fully agrees that these are areas for which there are not sufficient data to support the use of NATRECOR. The company will continue and build upon its efforts to educate physicians regarding appropriate use.”

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Viagra not always the best option for ED

Can you believe that Pfizer has spent over $100 million dollars to gain its 75% share of America's $2 billion erectile dysfunction (ED) market? That is a lot of money to burn on advertisements alone. The sad reality is that with too much advertising, the recipients of the message actually start believing some of the things that the companies tell them.

So Viagra has become not only a source of many jokes but also a noun and verb for some people. However, Viagra may not always be the best and the only solution for erecticle dysfunction (ED), according to The Geddings & Bessie Osbon Institute, an Augusta, Georgia based non-profit foundation. The organization recently surveyed 185 physicians and asked which ED treatment they considered the least invasive of all the treatment options available to men with the condition. In medical terms "invasive" treatments are those that impact the internal workings of the body, the treatment literally "invades" the body. While a cure is desirable, side effects are not, which is why physicians should attempt the "least invasive" treatment option first.

In the survey, 73% of the physicians surveyed listed "Oral Drugs" as the least invasive treatment for ED. Only 3% listed Psychotherapy and Vacuum Therapy as the right choices. Psychotherapy involves counseling and serves only those with psychosis. Vacuum therapy controls the condition in less than two minutes for the majority of cases which are organic in origin -- without introducing anything into the body.

"Vacuum therapy is the least invasive treatment for ED," said Mark Newell, Executive Director of the Institute, "but the advertising campaigns for Viagra, Levitra and Cialis have had a tremendous impact on the thinking of physicians and the public. It is an example of how drug company business can override the physician's Hippocratic Oath, which commands that practitioners first consider the least invasive treatment for a patient before using measures that have negative side-effects."

According to AUA guidelines, physicians should recommend vacuum therapy as the first choice therapy for patients with ED. The treatment uses a vacuum device to produce results in 90 seconds with no side effects or after effects when used as directed. Oral drugs, by comparison, can take hours to work. Some have side effects which caused many users to not refill their prescriptions. In addition to that Vioxx has been linked to sudden blindness in men, and while the FDA is investigating this linkage, there have been calls for a recall of Viagra.

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Zyprexa class action lawsuits settled

Readers will recall that Eli Lilly was facing class action lawsuits related to Zyprexa, an "atypical antipsychotic drugs" prescribed for the treatment of certain disorders, including schizophrenia and acute mixed and manic episodes of bipolar I disorder. Since its introduction, the drug has been taken by as many as 17 million people worldwide.

Eli Lilly has now announced that it has entered into an agreement in principle with plaintiffs' attorneys involved in Zyprexa liability litigation to settle a majority of the claims against Lilly relating to the medication. According to the agreement, Lilly will establish a fund not to exceed $690 million for plaintiffs who agree to settle their claims. The settlement fund will be overseen and distributed by claims administrators appointed by the plaintiffs' steering committee. At this time, the exact number of claimants covered by this settlement is unknown, but is estimated to be 8,000, comprising approximately 75 percent of claims identified to Lilly.

There are other hundreds of class action lawsuits related to drugs and recalls in process in the United States courts. Most notable are the Vioxx class action lawsuits against Merck and Bextra and Celebrex class action lawsuits against Pfizer. In recent days, Pfizer is also facing Viagra lawsuits.

Like most drug companies, Eli Lilly refused to settle the cases initially despite strong words froms consumer rights groups. Even while settling the claims, the company is adamant that it has done nothing wrong. In a statement, Eli Lilly reiterated that, "Our decision to resolve these claims does not change the fact that Zyprexa has and will continue to improve the lives of millions of patients around the world who are suffering from schizophrenia and bipolar
disorder."

When finalized, the settlement will resolve the majority of Zyprexa claims pending in the United States. This includes federal and state lawsuits that have been brought against Lilly, the filed nationwide class action lawsuits (none of which had been certified by a judge), and the majority of approximately 5,000 claims that were the subject of "tolling agreements" that extended the deadline for potential claimants to file a lawsuit, as well as other potential claims against Lilly. The agreement will also result in the dismissal of claims against physicians and other health care professionals named as co-defendants in any cases covered by this settlement.

Most of the lawsuits claimed that before September 2003, the information in the medication label, which listed the risk of hyperglycemia and diabetes as an infrequent adverse event since 1996, was not adequately displayed. In September 2003, the FDA required label changes for all atypical antipsychotics to warn against this risk. The US FDA refused to recall Zyprexa when requested by consumer rights groups.

The agreement involves claimants who asserted that they developed diabetes-related conditions from their use of Zyprexa. Claimants who are not covered by the final settlement are those represented by attorneys who are not participating in the agreement in principle. Lilly is prepared to continue its vigorous defense of Zyprexa in the remaining cases. Lilly will also take a $700 million pre-tax charge in the second quarter of 2005 to cover this settlement, as well as other product liability claims not covered by the settlement.

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Viagra lawsuit filed against Pfizer

A Louisiana man, James Thompson, has filedd the first lawsuit against Pfizer claiming that Viagra caused partial loss of vision. The FDA is currently investigating the link between Viagra and sudden blindness after a study was published by University of Minnesota in the Journal of Neuro-Ophthalmology with the findings. As expected, Pfizer continues to deny these charges and claims that Viagra is a safe drug. In the meantime, there have been calls for a recall of Viagra. (Related link: Complete coverage of Viagra recall news)

The attorney Daniel Becnel Jr is an expert in personal injury lawsuits and has been active in Bextra class action lawsuits as well. The suit is seeking approval as a class action. If class action status is granted, it will be among the largest class action lawsuits after Vioxx. Viagra has reportedly been used by 23 million men. While the number of instances of vision loss are few, a far larger number of men have impaired vision after they took Viagra. The condition, nonarteritic ischemic optic neuropathy (NAION), described as “stroke of the eye,” occurs when blood flow is cut off to the optic nerve, which injures the nerve and results in permanent vision loss.

The attorney has been quoted as saying in interviews with the media that he plans to file as many as 100 lawsuits nationwide against Pfizer in the Viagra case. The company is already facing thousands of lawsuits related to Bextra and Celebrex. In the Viagra case, however, the compensation being demanded is modest - approximately $75,000.

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Revatio, a form of Viagra, approved for PAH

Pfizer has announced that the U.S. Food and Drug Administration (FDA) has approved Revatio (sildenafil citrate) as a treatment for pulmonary arterial hypertension (PAH), a rare, aggressive and life-shortening vascular disease. Sildenafil citrate is the active ingredient in Viagra, Pfizer's erectile dysfunction medication used by more than 26 million men worldwide. It is important to point out that Viagra is currently being investigated by the FDA because of its linkage to sudden blindness in some men. It was, therefore, quite surprising that the US FDA will approve Viagra for another use while the investigation is still going on and calls for Viagra recall are mounting.

PAH is characterized by dangerously high pressure in the blood vessels that lead from the heart to the lungs. It is estimated to affect approximately 100,000 people worldwide. Symptoms include difficulty breathing, dizziness and fatigue. Left untreated, patients have an average survival time of less than three years from the time of diagnosis.

The FDA granted Revatio a priority review. This type of approval process has come under a lot of criticism lately since the drug firms abuse the system to get the drug approved faster without adequate testing. While the approval is contingent upon further testing but that rarely gets done and the FDA has no enforcement power. In any case, FDA has been accused by consumer rights groups of putting the interests of drug firms ahead of American people. (Related article: FDA's accelerated drug approval process is broken)

Revatio is the first oral treatment for PAH to be approved for patients with an early stage of the disease, allowing physicians to treat patients earlier in this progressive disorder. The most common side effects of Revatio are headache, dyspepsia, flushing, epistaxis, and insomnia. The Revatio 20 mg pill is white and round to distinguish it from Viagra's blue diamond-shaped pill for erectile dysfunction. Pfizer expects Revatio to be available in retail pharmacies in mid-July.
Revatio is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability. The efficacy of Revatio has not been evaluated in patients currently on bosentan therapy. The use of Revatio or Viagra and organic nitrates in any form, at any time, is contraindicated. Side effects were similar to the established safety profile of Viagra used for the treatment of ED.

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Oregon Vioxx victims unable to sue Merck

It is very unfortunate that the residents of the state of Oregon have to live with the fact their lives are less important than drug industry profits because the politicians are in bed with pharma companies like Merck and Pfizer. Like their fellow citizens in Michigan, they too have been denied the right to sue a drugmaker if it sells dangerous or even deadly drugs. The issue became more important after the recall of Vioxx by Merck. (Related article: Michigan and Texas victims can not sue Merck in Vioxx and Bextra recall cases)

While most Americans and even nationals of other countries worldwide are able to seek damages for personal injuries from American companies, some states in the US are unable to do so because these states have passed laws that favor drug companies rather than their own people.

Senator Charlie Ringo of Oregon State put it very clearly while speaking to Niki Sullivan of The Associated Press, "The power of the pharmaceutical lobby prevailed." The pharmaceutical lobby is so powerful in the United States that it is next to impossible to make any laws that hurt them even if they go against the interests of American people. Particularly with the Republican majorities in Washington, it is simply impossible for them to act against pharma companies since they receive almost all of the campaign contributions that drugmakers make.

Oregon victims were hoping that they would be able to sue Merck and also join Bextra class action lawsuits but it appears that the bill may be all but dead for now.

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Pfizer, the drugmaker that is facing thousands of lawsuits over its banned drug Bextra, and for its marketing practices for Celebrex (that has not been banned yet but carries a black box warning), is about to face lawsuits related to its other blockbuster drug Viagra. Recent reports indicate that Viagra may cause sudden loss of vision in some men and the FDA is investigating if a Viagra recall is needed. (Related article: Viagra and blindness link being investigated by FDA)

While recent reports put the number of affected at just about 50 (including Viagra, Cialis, and Levitra), the actual number may be larger. Due to the embarrassment attached with taking Viagra, most men are too shy to come out openly and talk about it. But it seems that men are now coming forward with their woes. Over 23 million men worldwide have used it since Viagra came onto the market in 1998.

For the past 6 months, Parker & Waichman, a law firm specializing in personal injury lawsuits, has been contacted by men who claim to have suffered loss of vision as a result of using Viagra (sildenafil citrate). The firm says that is has also received a significant number of inquiries from Cialis and Levitra users too who claim to have suffered vision loss after using those drugs.
Bill Federman, a class action lawyer based in Oklahoma City, is reported to have told James Doran of the Times Online of UK, “The issue here is that the public was never told that there was a potential ocular problem in taking Viagra, not a serious one such as is being claimed here.”
In the meantime, there is more trouble for Pfizer. Another study has established a link between higher incidence of STD and use of Viagra. Dr. Jeffrey Klausner, director of STD prevention and control services at the San Francisco Department of Health, says that more restrictions need to be put on Viagra prescriptions. And of course, Viagra is also the topic of discussion as some criminals were able to get government-provided Viagra.

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Vioxx, Bextra recall leave drug ads intact

Despite the recall of Vioxx and, most recently, Bextra from the market, consumers continue to respond to direct-to-consumer advertising (DTCA) at levels comparable to those reported prior to the Vioxx recall, according to the latest findings from Ipsos PharmTrends, a syndicated tracking study of consumer behavior by Ipsos, the global survey-based marketing research firm. In other words, while some recent data shows that spending on television advertising for prescription drugs has dropped somewhat, an average consumer is still being bombarded with too many ads for drugs. In fact, controversy surrounding a drug seems to have little impact on advertising. Therefore, even for controversial drugs like Viagra and Crestor, there is no letup in advertising.

Almost two in ten consumers (18%) took action following exposure to a prescription drug, and one out of ten (11%) requested a specific medication. These "call to action" results have shown only minimal erosion from pre-Vioxx recall levels, in which 19% of consumers took action following exposure to a prescription drug, and 12% requested a specific medication. Ad awareness, at 58%, is also consistent with findings from previous waves. Now if this sounds like a small percentage, remember that for other consumer products, these numbers are generally in single digits.

"Despite the latest recalls, prescription drug advertising continues to be an accepted and effective channel for communicating the availability of prescription drug solutions," says Barbara Bertner, Vice President, Ipsos-Insight's PharmTrends. "Americans, despite finding prescription druga dvertising annoying, believe that manufacturers should be able to advertise and that advertising provides a good source of information for alternativetherapies. Manufacturers are taking notice with a distinct change in creative style that is more serious in tone and presents the information in a more straightforward manner."

It is important to point out that per capita drug consumption in the United States is the higest in the world (despite as many as 45 million Americans without health insurance who rarely take prescription drugs and many senior citizens who do not take complete doses due to financial constraints). In other words, Americans are saying to drug companies "Give me more!"

Several branded prescription drugs show high levels of ad recall among their purchasers. Viagra tops the list this year, with nearly all its purchasers (89%) recalling seeing an ad for the erectile dysfunction drug in the year ending December 2004. Drugs entering the top ten ranking for the first time include Strattera (84% of purchasers ad aware), Detrol LA (82% of purchasers ad aware), and Aricept (80% of purchasers ad aware). Aricept exhibits the most significant movement upward, ranking eighth, up from thirty-sixth position one year ago.

Viagra has recently come under a cloud after it was reported that it may cause blindness in some men. It will be interesting to watch if prior if Americans will still take Viagra even though there are calls for a Viagra recall.

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