Personal Injury blog

FDA Report Urges Avandia to be Pulled from the Market

2010-02-22T18:43:00.002-05:00

Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market.

The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart. Avandia, intended to treat Type 2 diabetes, is known as rosiglitazone and was linked to 304 deaths during the third quarter of 2009.

"Rosiglitazone should be removed from the market," one report, by Dr. David Graham and Dr. Kate Gelperin of the Food and Drug Administration, concludes. Both authors recommended that Avandia be withdrawn.

The internal F.D.A. reports are part of a fierce debate within the agency over what to do about Avandia, manufactured by GlaxoSmithKline. Some agency officials want the drug withdrawn because they believe there is a safer alternative; others insist that studies of the drug provide contradictory information and that Avandia should continue to be an option for doctors and patients. GlaxoSmithKline said that it had studied Avandia extensively and that "scientific evidence simply does not establish that Avandia increases" the risk of heart attacks.

The battle has been brewing for years but has been brought to a head by disagreement over a new clinical trial and a Senate investigation that concluded that GlaxoSmithKline should have warned patients earlier of the drug's potential risks.

Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. But a 2007 study by a Cleveland Clinic cardiologist suggesting that the drug harmed the heart prompted the F.D.A. to issue a warning, and sales plunged. A committee of independent experts found in 2007 that Avandia might increase the risk of heart attack but recommended that it remain on the market, and an F.D.A. oversight board voted 8 to 7 to accept that advice.

Hundreds of thousands still take the medicine, although some top endocrinologists say they have sworn off the drug.

Since 2007, more studies have been done. In a December 2009 internal memorandum, Dr. Janet Woodcock, director of the F.D.A.'s drug center, wrote that "there are multiple conflicting opinions" about Avandia within the agency, and she ordered officials to assemble another advisory committee, expected this summer, to reconsider whether the drug should be sold.

"I await the recommendations of the advisory committee," the agency's commissioner, Dr. Margaret Hamburg, said Friday night. "Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved."

The bipartisan multiyear Senate investigation -- whose results are expected to be released publicly on Monday but which were also obtained by The Times -- sharply criticizes GlaxoSmithKline, saying it failed to warn patients years earlier that Avandia was potentially deadly.

"Instead, G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk," concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.

Mr. Baucus said of the report, "Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust."

In response, GlaxoSmithKline said that it disagreed with the Senate investigation's conclusions. The company said that it could not comment on internal F.D.A. documents but that "the official ruling from F.D.A. is that Avandia remain on the market."

In the wake of the controversy, agency officials ordered GlaxoSmithKline to undertake a study comparing how many heart attacks, strokes and heart-related deaths occur among patients given either Avandia, Actos or a placebo. Studies suggest that Actos, made by Takeda, lowers blood sugar as well as Avandia but without hurting the heart as much.

But Dr. Graham and Dr. Gelperin, working in the F.D.A.'s office of surveillance and epidemiology, argued in two separate internal reports that the new GlaxoSmithKline study, called TIDE, is "unethical and exploitative" because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. The trial may include patients who have had heart attacks or chest pains even though some foreign drug authorities have warned against Avandia's use by precisely such patients, the reports note.

"Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable," one of the reports concludes.

These concerns, in internal reports dated October 2008 but not made public until now, were later overruled by other agency officials, and GlaxoSmithKline is currently enrolling patients in the TIDE trial. The trial is not expected to be completed until 2020, although the company is hoping to report some results to the F.D.A. by 2014. The company's patent on Avandia expires in 2012, and generic versions will probably swallow most remaining profits.

In a letter sent Thursday to Dr. Hamburg, the Food and Drug Administration commissioner, Mr. Baucus and Mr. Grassley asked "what steps the F.D.A. has taken to protect patients in the TIDE trial" and said the trial's patients had never been told about the concerns raised by the agency's own safety officers.

Mr. Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. Graham and Dr. Gelperin over their counterparts who approve medicines and deal more directly with drug makers.

"It doesn't make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision," Mr. Grassley said. "The Avandia case may be the most alarming example of the problem with this setup."

The question of when and how to communicate possible drug risks has long bedeviled drug makers and regulators. Hints are common that drugs may cause injuries; thousands of drug injury reports pour into the Food and Drug Administration every week. For example, Avandia ranked first among all prescribed drugs in the number of serious, disabling and fatal problems -- including 304 deaths -- reported to the agency in the third quarter of 2009, according to an analysis done by the Institute for Safe Medication Practice, a drug safety oversight group.

But companies say that such reports do not offer proof of a problem and that highlighting them can scare patients away from needed treatment, so they often argue that more certainty is needed before alarms are raised. GlaxoSmithKline said a "vast majority" of the recent reports regarding Avandia was related to litigation.

The Senate investigation -- the result of years of digging through more than 250,000 internal company documents -- concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.

In November 2003, for instance, the company completed a study in which diabetics given Avandia had far more heart problems than those given placebos. Two months later, the World Health Organization sent the company an alert linking Avandia to heart ailments. In a June 2004 meeting, the company's Global Safety Board said a hard look should be taken at all Avandia clinical trials for more signs of heart problems, documents show.

European regulators had earlier ordered GlaxoSmithKline to conduct a study -- called the Record trial -- to examine Avandia's heart risks because hints of these problems appeared in the company's earliest trials.. But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.

So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying.

In 2005, executives revealed the results of their meta-analysis to the F.D.A., and in 2006 they provided the agency with the underlying data.

Two large company-sponsored trials -- called Dream and Adopt -- were published near the end of 2006, and each provided more hints that Avandia hurts the heart, the documents show. In a March 2007 meeting of the company's Diabetes Franchise Cardiology Advisory Board, advisers called the safety worries found in these many studies "disquieting." Negotiations with agency officials about how and whether to alert the public continued.

Meanwhile, the company continued to market and advertise Avandia aggressively. The Senate inquiry concludes that the company threatened doctors who suggested in public that Avandia might have serious risks.

In 1999, for instance, Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania.

GlaxoSmithKline said that it "does not condone any effort to silence" scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation "could have been handled differently."

You can read more about Avandia and it's history here: http://www.thesandersfirm.com/avandia

New Scientific Studies Show Further Evidence of Avandia Dangers

2010-02-04T14:50:00.001-05:00

Two independent studies document serious medical risks associated with use of popular GlaxoSmithKline diabetes drug

Mineola, NY (Lexis Nexis) February 4, 2010 -- Pharmaceutical giant GlaxoSmithKline is about to suffer more setbacks in the ongoing battle of opinions concerning the safety of its much touted diabetes drug Avandia, according to Marc Grossman, senior partner of leading national personal injury law firm of Sanders Viener Grossman, LLP, in Mineola, N.Y.

The American Diabetes Association has accepted for publication in its prestigious medical journal, Diabetes Care, a study by Harvard researchers that shows users of the diabetes drug Avandia have more than double the risk of a heart attack compared to other diabetes drugs. Further, a jointly sponsored study by both GlaxoSmithKline and i3 Drug Safety, an independent drug-safety firm, will appear in the journal Clinical Therapeutics, showing that Avandia users have a 35-41% increased risk of a heart attack over users of Actos©, Avandia's main competitor.

These findings are the latest in a series of published studies that indicate Avandia users are at an unacceptably increased risk of a heart attack. In 2007, the Food and Drug Administration required a "Black Box" warning be added to Avandia's label about the heart risks associated with drug, but allowed the product to remain on the market even though numerous Endocrinologists and other diabetes experts called for its removal from the market like the other ill-fated drugs Vioxx and Rezulin.

The Harvard group analyzed clinical care data taken from the electronic medical records of patients at several Boston area hospitals and clinics associated with Harvard Medical School. All 26,375 patients records reviewed included a diagnosis of Diabetes and the use of at least one oral diabetic medication used between years 2000 and 2006. The researchers then reviewed the records for all patients who suffered "Myocardial Infarction" or heart attack. The incidence of heart attack was more than double for Avandia compared to its competitor Actos. The researchers chose Avandia to confirm their methodology because of its known "…relative adverse cardiovascular risk profile…" The GlaxoSmithKline-i3 study analyzed health-insurance data from July of 2000 through March of 2007 for 2 groups of 47,501 subjects each; one group using Avandia and the other Actos.

Almost 13,000 former Avandia users who have suffered heart attacks and other significant injuries have filed claims against GlaxoSmithKline in both Federal and State courts.

"This study adds to the overwhelming evidence that Avandia causes heart attacks in an already vulnerable population and it further confirms the basis of these lawsuits," said Marc Grossman, a New York attorney who represents hundreds of former Avandia users in Federal Court in Philadelphia. "It's very disturbing to see what appears to be a pattern of pharmaceutical corporations placing profits ahead of people. The recent studies raise serious questions about the health risks associated with Avandia, yet GSK continues to shirk its responsibility to the thousands of victims of Avandia whose lives are ruined or lost."

The Sanders Firm is a National Law Firm and has recovered over $500 Million for its clients, including thousands of victims of defective drugs and products. For further information or press inquiries, please contact Marc Grossman at 1-800-FAIR-PLAY, via email at mgrossman(at)thesandersfirm(dot)com or go to www.thesandersfirm.com.

Nasal Spray Damage Sense of Smell?

2009-06-19T18:58:00.002-04:00

FDA advises consumers not to use certain Zicam cold remedies.

Consumers should stop using Zicam Cold Remedy nasal gel and related products because they can permanently damage the sense of smell, federal health regulators said Tuesday.

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration’s announcement are adult and kid-size Zicam Cold Remedy Nasal Swabs.

The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives’ Zicam products since 1999. Shares of the Scottsdale, Ariz.-based company plunged to a 52-week low after the FDA announcement, losing more than half their value.

“Loss of the sense of smell is potentially life threatening and may be permanent,” said Dr. Charles Lee. “People without the sense of smell may not be able to detect life dangerous situations, such as gas leaks or something burning in the house.”

The FDA said Zicam Cold Remedy was never formally approved because it is part of a small group of remedies that are not required to undergo federal review before launching. Known as homeopathic products, the formulations often contain herbs, minerals and flowers.

A warning letter issued to Matrixx on Tuesday asked the company to stop marketing its zinc-based products, but the agency did not issue a formal recall. Instead, regulators said Matrixx would have to submit safety and effectiveness data on the drug.

“The next step, if they wish to continue marketing Zicam intranasal zinc products, is for them is for them to come in and seek FDA approval,” said Deborah Autor, director of FDA’s drug compliance division.
The agency is requiring formal approval now because of the product’s safety issues, she added.

Growing homeopathic marketThe global market for homeopathic drugs is about $200 million per year, according to the American Association of Homeopathic Pharmacists. The group’s members include companies like Nutraceutical International Corp. and Natural Health Supply.

Matrixx has settled hundreds of lawsuits connected with Zicam in recent years, but says on its Web site: “No plaintiff has ever won a court case, because there is no known causal link between the use of Zicam Cold Remedy nasal gel and impairment of smell.”

The company said in a statement Tuesday that the Zicam Cold Remedy’s safety is “supported by the cumulative science and has been confirmed by a multidisciplinary panel of scientists.”

But government scientists say they are unaware of any data to support Zicam’s labeling, which claims the drug reduces cold symptoms, including “sore throat, stuffy nose, sneezing, coughing, congestion.”

Matrixx said it will consider withdrawing the products, which accounted for about 40 percent of its $111.6 million in sales last year.

Facing multiple lawsuitsHealth officials said they have asked Matrixx executives to turn over more than 800 consumer complaints concerning lost smell that the company has on file. A 2007 law began requiring manufacturers to report such problems, but FDA regulators declined to say Tuesday whether the company broke the law.

The 130 reports received by the FDA came entirely from physicians and patients, not the manufacturer.

Regulators said the relatively small number of complaints accounted for the agency’s lengthy investigation.

“FDA doesn’t take action against drug products without evaluating all of the circumstances surrounding the issues with the product,” Lee said.

For more information, visit: www.thesandersfirm.com/zicam

Hydroxycut Recalled due to liver damage.

2009-06-19T18:55:00.002-04:00

On May 1, 2009, The Food and Drug Administration (FDA) announced a warning to all Hydroxycut consumers to immediately stop the use of the dietary supplement produced by Iovate Health Science Inc., of Oakville, Ontario. According to the FDA number of Hydroxycut products are associated with several serious liver injuries. The drug manufacturer has agreed to recall the product from the market.

In the report the FDA stated that it has received over 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, which is an indicator of potential liver injury that can lead to liver damage requiring liver transplants.

While the report claims that liver damage cases were rare, they were nevertheless reported by patients taking Hydroxycut doses as prescribed on the bottle. Symptoms of liver damage include jaundice (yellowing of the skin or white of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

Chief Medical Officer Linda Katz, M.D., of the FDA's Center for Food Safety and Applied Nutrition, urged consumers to discontinue use of Hydroxycut to avoid serious health complications.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:

•Hydroxycut Regular Rapid Release Caplets
•Hydroxycut Caffeine-Free Rapid Release Caplets
•Hydroxycut Hardcore Liquid Caplets
•Hydroxycut Max Liquid Caplets
•Hydroxycut Regular Drink Packets
•Hydroxycut Caffeine-Free Drink Packets
•Hydroxycut Hardcore Drink Packets (Ignition Stix)
•Hydroxycut Max Drink Packets
•Hydroxycut Liquid Shots
•Hydroxycut Hardcore RTDs (Ready-to-Drink)
•Hydroxycut Max Aqua Shed
•Hydroxycut 24
•Hydroxycut Carb Control
•Hydroxycut Natural

Although the FDA did not receive serious liver damage related reports regarding all of the Hydroxycut products, the manufacturer has agreed to withdraw all of the above products from the marketing at this time.
If you or someone you know has been injured or experienced serious side effects from Hydroxycut, contact our law offices immediately for a free online, over the phone or in person consultation.

Chantix Investigation. BBC News

2009-06-19T18:48:00.003-04:00

To watch the rest of the video visit: http://www.thesandersfirm.com/articles/read/?SAf5551e_2

Sanders Law Firm Files Claim for Good Samaritan Beaten by NYC Cops Gone Wild

2008-08-27T12:17:00.003-04:00

Marc Grossman, Senior Partner of the law firm of Sanders, Sanders, Block, Woycik, Viener & Grossman, P.C. in Bronx, New York, announced today that it has just filed a Notice of Claim against The City of New York and The New York City Police Department on behalf of Cyle Perry-Osby with regard to the injuries he sustained when he was violently assaulted by 2 female New York City Police Officers in the highly publicized incident of August 15, 2008. The filing of the Notice of Claim is a pre-requisite to filing a lawsuit against The City of New York.

Cyle Perry-Osby was driving on 218th Street in the Bronx when he came upon New York City Police Officers Michelle Anglin and Koleen Robinson, who were assaulting a motorist at the intersection of White Plains Road and 218th Street. When Mr. Osby questioned the 2 females as to what was happening, one of the officers replied "You don't know who you're f---ing with, we're the f---ing cops." The officers then sprayed mace on Mr. Osby and struck him in the head and face. One of the officers then held a gun to Mr. Osby's face, causing Mr. Osby to fear for his life, before the officers finally left the scene.

Mr. Osby was immediately treated at Our Lady of Mercy Medical Center for a severe head injury and will require continued medical attention.

Mr. Osby was only trying to be a good Samaritan and assist a man he saw was in trouble. Mr. Osby is with his family now trying to recover and is thankful that arrests have been made in this case. Attorney Michael Villeck, Esq. of the firm believes "It's a terrible injustice when people abuse their position of power. When those entrusted with preserving civility and protecting the public commit this type of horrendous act and cause serious injury to innocent civilians, the entire city suffers."

Sanders, Sanders, Block, Woycik, Viener & Grossman, P.C. has extensive experience handling litigation involving assaults, excessive force and violation of civil and constitutional rights. The firm has received broad media coverage over its recently filed product liability lawsuits against Pfizer, Inc., the manufacturer of the hugely popular Chantix smoking cessation drug; and for its role in the ground-breaking $4.85 Billion Vioxx settlement against Merck & Co. According to Marc Grossman, "It's been a very busy Summer for the Firm which, in a recent span of just 8 days, recovered 8 million dollars in damages for its clients, including a 5 million dollar product liability settlement."

For more information about the firm, contact Marc Grossman, Esq. at 1-800-FAIR -PLAY or via email to mgrossman@thesandersfirm.com or click here.

Chantix pulled from Military Base Pharmacy

2008-08-11T15:58:00.001-04:00

Not letting people who are carrying rifles to take a drug that has been linked to suicide sounds like a good idea to me. Marc Grossman

In the US, Chantix has been linked to at least 40 suicides and 400 attempted suicides. In November 2007, the Food & Drug Administration (FDA) issued an “Early Communication” that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In February, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with black box warning - the agency’s highest safety alert.

The decision to remove Chantix from the pharmacy at the Yokata Air Base was made after the non-profit Institute for Safe Medication Practices issued a report detailing Chantix adverse event reports to the FDA. The report, which was released in May, specifically cited 224 reports of potential heart-rhythm disturbances, 372 reports of possible movement disorders and 544 reports of likely glycemic problems, including diabetes. There were also reports of a dozen traffic accidents linked to Chantix.

The report noted that in the fourth quarter of 2007, Chantix accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period.

Two days after the institute’s report, the Defense Department’s Office of the Chief Medical Officer recommended that Chantix “should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”

According to the “Stars and Stripes” website, no Chantix patients at Yakota have reported any adverse reactions. A patient with approval from his doctor can opt to continue the medication, and special order the drug. In the meantime, Yokota has suspended all refills of Chantix until patients review with their health care provider the potential risks and benefits of continuing the drug.

Since Chantix was approved by the FDA in 2006, the number of military prescriptions for the drug has exploded. In 2006, only 262 Chantix prescription were written at U.S. military medical facilities. By 2007, that number had jumped to 67,580.

Source: newsinferno.com/archives/3606

New York-Based Sanders Law Firm Files Five Product Liability Lawsuits Against

2008-08-08T12:06:00.002-04:00

Leading personal injury law firm representing families of individuals who suffered from suicidal thoughts and erratic behavior while taking popular smoking cessation drug.

Mineola, N.Y. (Lexis Nexis) August 5, 2008 - Marc Grossman, senior partner of leading national personal injury law firm Sanders Viener Grossman LLP, today announced that he has filed five separate product liability lawsuits against Pfizer, Inc., manufacturer of the hugely popular Chantix smoking cessation drug.

The lawsuits (Cases 110517/08, 110518/08, 110519/08, 110520/08 and 110561/08) were filed in the Supreme Court of New York, New York County, and claim that each of the plaintiffs either committed or attempted suicide while suffering from neuropsychiatric side effects that resulted from taking Chantix.

Chantix has been prescribed to more than 6 million people worldwide since its launch in August 2006 and has been approved for use in more than 70 countries as a drug to assist adults who want to quit smoking. However, recent studies have shown that Chantix may cause serious adverse side effects, such as suicidal thoughts and erratic behavior.

Earlier this year, the U.S. Food and Drug Administration (FDA) issued an alert "to highlight important revisions to the warnings and precautions sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms."

"We've been investigating claims regarding Chantix ever since the FDA's initial communications about reported side effects, so our firm was well-prepared to vigorously represent our clients when we were contacted by their families," said Grossman. "For those familiar with this year's Tony Award-winning play, 'August: Osage County,' which has sparked debate about the risks of suicide and dysfunction stemming from prescription drug use, the fact that we are filing these actions on the eve of August 1st is a tragic illustration of life imitating art."

The filing of the Chantix lawsuits continues an extremely active year for Sanders Viener Grossman, in which the firm has secured a series of large settlements on behalf of its clients. The firm recently recovered large settlements for approximately 300 plaintiffs involved in the Vioxx-related litigation with Merck & Co. Last month, Sanders Viener Grossman recovered $8 million in damages for its clients over a span of just eight days, including a $5 million recovery
in a product liability case.

According to Grossman, the firm has extensive experience with defective drug litigation and can provide Chantix victims with free consultations and case reviews to make sure their legal rights are protected.

For more information about Sanders Viener Grossman LLP, please visit http://www.thesandersfirm.com/ or call 1.800.FAIRPLAY.

Fentanyl-containin pain patches recalled

2008-02-19T16:27:00.003-05:00

February 13th and February 18th the Food & Drug Administration announced recalls for Fentanyl-containing pain patches. It has become a concern that the patches may leak and expose the person to dangerous levels of Fentanyl which considered a class II substance by the Drug Enforcement Administration (DEA). Fentanyl is an opiate that is 80 times more potent than morphine, which means that it is potential for abuse and a risk for fatal overdose.

for more information about Fentanyl-containing patch recalls visit the personal injury news section.

FDA reviewing Vytorin cholesterol drug

2008-01-29T17:38:00.000-05:00

Recent study showed it wasn't any better than a generic medication

January 25, 2008 | MSNBC

U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc’s and Schering-Plough Corp’s popular cholesterol drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.

The Food and Drug Administration said it had not yet received a final report on the study, called Enhance. The agency’s review of Vytorin will take about six months after final results are received, the FDA said.

In the meantime, patients with questions about the Enhance study should talk with their doctors, the FDA advised.

“At this time, it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone,” an FDA statement said.

Simvastatin is the generic name for Zocor. Vytorin combines Zocor with a newer cholesterol-fighting pill called Zetia.

The FDA review puts an even bigger spotlight on a debate over Vytorin’s value in the wake of the Enhance results early last week and concern over a long delay in releasing the data.

Decline in Vytorin prescriptions
Major medical groups, prominent cardiologists and U.S. lawmakers have weighed in, while prescriptions for the drug have slipped.

“The FDA is attempting to buy time so noise can be filtered out and cooler heads can look at the Vytorin data, but it is unlikely even the FDA will be able to draw clear conclusions,” said Viren Mehta, principal at Mehta Partners, which provides investment advice to the global pharmaceutical and biotechnology industries.

“For a clear picture, we will need to wait for outcomes data (data on heart attack and stroke risk) from larger Vytorin trials” due by 2010 or 2011, Mehta said.

Merck and Schering-Plough sell Vytorin and Zetia in a joint venture, and the products have combined annual sales of about $5 billion.

The Enhance study examined Vytorin against Zocor alone in patients with a rare genetic predisposition to dangerously high cholesterol levels. Vytorin failed to halt the clogging of neck arteries better than Zocor alone, but it did a better job of reducing “bad” LDL cholesterol.

Beyond Vytorin, the FDA said it also would review “whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.” High LDL is commonly believed to be a major risk factor for heart disease.

FDA officials cautioned the public not to overreact to the Enhance study by turning away from cholesterol-lowering drugs.

Drugs that cut LDL are among the largest selling drugs in the world, and also include Pfizer Inc’s Lipitor and AstraZeneca Plc’s Crestor. Shares of Pfizer and AstraZeneca were also lower after the FDA announcement.

Lipitor, Zocor and other drugs in the same statin class have consistently shown the ability to reduce heart attacks and strokes by up to 30 percent.

Drugmakers criticized for delay
The drugmakers have been criticized by doctors, industry analysts and lawmakers for delaying presentation of results from the trial, which was concluded in 2006, until last week.

“The delay has made everyone uncomfortable,” Mehta said. ”We don’t know why they didn’t come out earlier and just say ... the trial was not showing any possible benefit” in cutting plaque.

Deborah Cohn, a professor of marketing at Touro College Graduate School of Business in New York, said the delay in releasing the results had caused an understandable backlash.

“Consumers feel like there may be something else they’re not telling us,” Cohn said. “Nobody likes feeling like they’re being lied to and that’s how everybody’s reacting.”

Merck spokesman Christopher Garland said the company ”welcomes today’s statement from the FDA as it appropriately communicates information about the Enhance trial as well as information about Vytorin and Zetia.”

A Schering-Plough spokesman could not immediately be reached after the FDA announcement.

Pfizer Strengthens Suicide Warning On Chantix Label

2008-01-29T17:35:00.000-05:00

January 19 , 2008 | Pharmalot.com

The drugmaker updates the label to reflect ongoing concern that the anti-smoking drug is connected to suicidal thoughts and behavior.

You may call last November, the FDA began reviewing cases of suicidal thoughts and aggressive and erratic behavior in Chantix patients that were received from Pfizer, along with a number of reports from the media and internet sites. At the time, the agency wrote on its web site that “a preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation and changes in emotion and behavior within days to weeks of taking Chantix.”

And so today Pfizer says its updated label includes a warning “that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” No figures were immediately available on cases reported.

A notable example, however, that drew national attention to Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.

The FDA, meanwhile, had asked Pfizer for on additional cases that may be similar. The agency is “currently evaluating the material Pfizer submitted in response” as well reports of drowsiness in people taking Chantix who had difficulty driving or operating machinery. We are awaiting an update from Pfizer concerning the info provided to the agency.

OxyContin: Under attack, drug maker turned to Giuliani

2008-01-03T15:20:00.000-05:00

December 28, 2007 | The New York Times

In western Virginia, far from the limelight, United States Attorney John L. Brownlee found himself on the telephone last year with a political and legal superstar, Rudolph W. Giuliani.

For years, Mr. Brownlee and his small team had been building a case that the maker of the painkiller OxyContin had misled the public when it claimed the drug was less prone to abuse than competing narcotics. The drug was believed to be a factor in hundreds of deaths involving its abuse.

Mr. Giuliani, celebrated for his stewardship of New York City after 9/11, soon told the prosecutors they were wrong.

In 2002, the drug maker, Purdue Pharma of Stamford, Conn., hired Mr. Giuliani and his consulting firm, Giuliani Partners, to help stem the controversy about OxyContin. Among Mr. Giuliani’s missions was the job of convincing public officials that they could trust Purdue because they could trust him.

So it was no small success when, after the call, Mr. Brownlee did what many people might have done when confronted with such celebrity: He went out and bought a copy of Mr. Giuliani’s book, “Leadership.”

“I wanted to be prepared for my meetings with him,” Mr. Brownlee said in a recent interview.

Increased scrutiny
Over the past few weeks, Mr. Giuliani’s consulting business has received increasing scrutiny, at times forcing him to defend his business as he campaigns for the Republican presidential nomination.

But his work for Purdue, the company’s first and longest-running client, provides a window into how he used his standing as an eminent lawyer, a Republican insider and a national celebrity to aid a controversial client and build a business fortune.

A former top federal prosecutor, Mr. Giuliani participated in two meetings between Purdue officials and the head of the Drug Enforcement Administration , the agency investigating the company. Giuliani Partners took on the job of monitoring security improvements at company facilities making OxyContin, an issue of concern to the D.E.A.

As a celebrity, Mr. Giuliani helped the company win several public relations battles, playing a role in an effort by Purdue to persuade an influential Pennsylvania congressman, Curt Weldon, not to blame it for OxyContin abuse.

Despite these efforts, Purdue suffered a crushing defeat in May at the hands of Mr. Brownlee when the company and three top executives pleaded guilty to criminal charges.

Mr. Giuliani, who declined to discuss his work for Purdue for this article, has refused to talk in detail about his firm’s clients. He has said that he is no longer involved in the day-to-day management of the firm, which still represents Purdue.

Giuliani Partners would not say how much Purdue had paid it, but one consultant to the drug maker estimated that Mr. Giuliani’s firm had, in some years, earned several million dollars from the account.

“Everything I did with Giuliani Partners has been totally legal, totally ethical,” Mr. Giuliani recently told The Associated Press. “There’s nothing for me to explain about it. We’ve acted honorably, decently.”

In the OxyContin case, Mr. Giuliani’s supporters suggest that as a cancer survivor himself, he was driven by a noble goal: to keep the company’s proven pain reliever available to the widest circle of sufferers.

“I understand the pain and distress that accompanies illness,” Mr. Giuliani said at the time. “I know that proper medications are necessary for people to treat their sickness and improve their quality of life.”

To drive OxyContin’s sales, Purdue, beginning in 1996, set in motion what D.E.A. officials described as perhaps the most aggressive promotional campaign for a high-powered narcotic ever undertaken. It promoted the drug not only to pain specialists, but to family doctors with little experience in treating serious pain or recognizing drug abuse.

As a result of the expanded access, critics charged, OxyContin wound up in the high schools and street corners of rural America where curious teenagers crushed the pill, defeating the time-release formula, and ended up addicts, or in some cases, dead.

Dennis Lee, the Virginia state prosecutor for Tazewell County, an area hard hit by OxyContin abuse, said he was stunned several years ago to learn that Mr. Giuliani was working for Purdue. He had a favorable impression of Mr. Giuliani, he said, and a poor opinion of the company, which he said had played down and dissembled about its drug’s problem.

“I was shocked,” Mr. Lee said, “that he would basically become a mouthpiece for Purdue.”

Denials and lobbying
Giuliani Partners served clients with a range of needs. The firm helped large accounting firms fight computer hackers and promoted Nextel’s efforts to expand its access to public airwaves. But some of the 55-person firm’s clients, like Purdue Pharma, were facing more difficult legal and public relations problems.

There were, for instance, the backers of a planned natural gas terminal in Long Island Sound who were facing stiff environmental opposition. Another client was a former cocaine smuggler hoping to win federal contracts for a computer system to track down terrorists.

On the business of these clients andothers, Giuliani Partners carved out a lucrative niche in corporate consulting, crisis management and security.

In the process, Mr. Giuliani, a Brooklyn native whose legal career had largely been spent in government, became a corporate trouble-shooter with homes in the Hamptons and on the Upper East Side. According to financial disclosure forms filed in May, his net worth was more than $30 million.

The crisis that brought Purdue to Mr. Giuliani in 2002 involved OxyContin, a time-released form of the narcotic oxycodone, which had turned into a blockbuster product with annual sales of more than $1 billion.

But along the way, the pain medication had also become a popular drug for abuse. Among the company’s critics were officials at the Drug Enforcement Administration who said OxyContin had been a factor in hundreds of overdose deaths. Some D.E.A. officials and others also charged that Purdue had hyped the drug’s resistance to abuse and then failed to act swiftly when its misuse became apparent.

Purdue Pharma, which is owned by the Sacklers, a New York-area family who are known as museum benefactors, denied it had done anything wrong. But facing a growing number of investigations and lawsuits, it spent millions on public relations experts, lobbyists and top-tier law firms.

One piece, however, was missing: a highly credible and well-connected political figure to serve as its point man. Purdue Pharma executives saw Mr. Giuliani as that person, said a former company spokesman.

“He was just on the cover of Time Magazine, Man of the Year,” that former official, Robin Hogen, said. “Everyone was talking about his extraordinary leadership in 9/11.”

Giuliani Partners became involved in every aspect of the company’s problems, from the ballooning investigation by Mr. Brownlee to repairing its battered image. Mr. Giuliani personally took on some tasks, but a half-dozen members of his firm, including Bernard B. Kerik , the former New York City police commissioner, were also involved.

Mr. Giuliani’s most important liaison to the company was Daniel S. Connolly, who had been a top lawyer in his administration. He spent so much time at Purdue that he was issued a security pass.

“His judgment was always sought on almost any topic,” said Mr. Hogen, who now works for a public relations agency in San Francisco.

Mr. Connolly regularly attended Monday morning crisis management sessions to develop programs that would shift the public spotlight away from OxyContin. The issue, the company said, was not its conduct but the larger question of prescription drug abuse.

To help draw attention to that issue, Mr. Giuliani became the public face of a program called Rx Action Alliance, a consortium of drug makers, physicians and law enforcement authorities working to curtail such abuse.

“He was America’s mayor,” Mr. Hogen said of Mr. Giuliani’s role as a catalyst for the company’s efforts. “People were drawn to him.”

One person attracted by Mr. Giuliani’s star power was Mr. Weldon, who was upset because young people in his Pennsylvania district were abusing OxyContin. Mr. Weldon, who lost his seat in 2006, said in a recent interview that he had told the company he planned to publicly speak out against it.

“This is really kind of outrageous,” Mr. Weldon recalled telling a Purdue representative. “You have got to do something more than say you are concerned about it.”

At Mr. Weldon’s urging, the company agreed to finance a program aimed at curbing prescription drug abuse. It also sent Mr. Giuliani to an inaugural press conference for the program, held at a high school in Mr. Weldon’s district. With Mr. Giuliani at his side, Mr. Weldon opted not to criticize the company.

“I am proud to be in Pennsylvania today standing with Curt Weldon — a true leader,” Mr. Giuliani said at the event. “I applaud the efforts of Congressman Weldon and of Purdue Pharma in taking this battle in the right direction.”

Credit for damage control
Asa Hutchinson , the director of the Drug Enforcement Administration in 2002, hardly needed an introduction to Mr. Giuliani. So it was perhaps not surprising that Purdue chose Mr. Giuliani as the person to meet with Mr. Hutchinson at a time when the drug maker was under intense scrutiny by the D.E.A.

“You need to have somebody who has clout to get in the door to legitimately make your presentation,” said Jay P. McCloskey, a former United States attorney in Maine who until recently worked for Purdue as a consultant.

By 2002, Mr. Giuliani was already helping to raise money for a D.E.A. museum, and his firm was part of a $1 million Justice Department consulting contract to advise it on reorganizing its major drug investigations.

The D.E.A. was not only critical of how OxyContin had been marketed, its inspectors had found widespread security and record-keeping problems at the company’s manufacturing plants.

Several top D.E.A. staffers were recommending that the agency impose severe sanctions against the drug maker, including possible restrictions on how much OxyContin it could make.

At two meetings, the first at Giuliani Partners in early 2002, Mr. Giuliani and Purdue’s executives argued that they were already taking steps to eliminate any problems.

Mr. Kerik had been sent to Purdue’s manufacturing plants to revamp internal security, they assured Mr. Hutchinson. The federal investigators, they argued, should back down and give them a chance to prove they could handle the problem on their own.

After the meetings, Mr. Hutchinson, who generally did not get involved in individual investigations, asked D.E.A. officials several times to brief him on the inquiry, Laura Nagel, the official in charge of it, has said in previous interviews. She declined to comment for this article.

D.E.A. officials say Mr. Giuliani ultimately did not affect the inquiry’s course. But Purdue Pharma did succeed in favorably resolving the matter. In 2004, it paid a $2 million fine to settle the D.E.A. record-keeping charges without admitting any wrongdoing. The sum was far smaller than the amount first recommended by Ms. Nagel, which one former D.E.A. official said was $20 million.

By the time of the 2004 settlement, it appeared that Purdue, with Mr. Giuliani’s help, had averted any significant damage. As the tide was turning, the drug maker’s top lawyer, Howard R. Udell, gave credit to Mr. Giuliani.

“We believe that government officials are more comfortable knowing that Giuliani is advising Purdue Pharma,” Mr. Udell said in a promotional brochure put out by Giuliani Partners. “It is clear to us, and we hope it is clear to the government, that Giuliani would not take an assignment with a company that he felt was acting in an improper way.”

Parents not persuaded
The limits of stature, though, were evident in Mr. Giuliani’s dealings with Mr. Brownlee, the federal prosecutor from Virginia, whose case against Purdue had been viewed by the company more as a nuisance than a threat.

It is easy to see how lawyers for Purdue might have underestimated the prosecutor. He ran a small office with 24 lawyers to cover 52 far-flung counties. But two of those lawyers, working out of a satellite office in the tiny town of Abingdon, Va., near the Tennessee border, had been investigating Purdue since 2002.

They had issued some 600 separate subpoenas and collected millions of company documents. The case stretched the office’s resources so thin that state prosecutors had to be deputized to handle other federal cases.

By comparison, Purdue’s defense team comprised all-stars, including Mr. Giuliani, Mr. Connolly and Mary Jo White , a former United States attorney in New York.

Mr. Giuliani had been advising Purdue about how to respond to Mr. Brownlee’s inquiry since its start in 2002, including reviewing documents the company had released in response to his subpoenas. And he shared the defense team’s view that Mr. Brownlee did not have any evidence to link the company to crimes, several of those lawyers said.

Early last year, however, Mr. Brownlee told Purdue that he was prepared to indict it and three top executives, including Mr. Udell, the lawyer. The company then handed Mr. Giuliani his most crucial assignment, to talk Mr. Brownlee down.

His selection was not by chance, company representatives said. They figured Mr. Brownlee, a younger federal prosecutor, would look up to Mr. Giuliani, who became a legend as a United States attorney in New York.

Between June and October 2006, Mr. Giuliani met or spoke with the prosecutor on six occasions. During those conversations, Mr. Giuliani was cordial but pointed in arguing against what he felt were flaws in the case.

Mr. Brownlee would not change course, though, even when the Purdue legal team appealed, unsuccessfully, at the 11th hour to his superiors at the Justice Department in Washington.

In October 2006, Mr. Brownlee told Mr. Giuliani and Purdue that he expected to ask for a grand jury indictment by the end of the month. Plea discussions ensued and Mr. Brownlee ultimately agreed that the three executives would not have to do jail time.

By this time, Mr. Giuliani was actively planning his presidential bid, as well as tending to other clients. On the day the legal team completed the plea deals with Mr. Brownlee, Mr. Giuliani was in Germany, giving a talk to business leaders.

He had a conference call with prosecutors for about a minute, but there really was not much left to discuss, except the weather.

“He said that it was raining,” Mr. Brownlee recalled.

In May, Purdue and its executives, after spending tens of millions of dollars to repair the company’s image, agreed to plea deals to avoid a trial. Together, they paid $634.5 million in fines and payments.

After years of denial and a high-profile public relations campaign, the company was forced to admit that it had misled doctors and patients. But to the parents of young people who had died getting high on OxyContin, the absence of jail time was evidence of Mr. Giuliani’s influence.

They voiced that view inside and outside the packed courtroom in Abingdon where the men were sentenced in July.

Mr. Giuliani was 360 miles away at the time, campaigning in Myrtle Beach, S.C., where he met with local firefighters and talked about 9/11. But his role in the case had been so substantial and sustained, the presiding judge felt compelled to address the parents’ concerns.

“It has been implied that because Mr. Giuliani is a prominent national politician, Purdue may have received a favorable deal from the government solely because of politics,” said the judge, James P. Jones of United States District Court. “I completely reject this claim.”

Even today, some of those parents are not persuaded. Ed Bisch, whose son died of an OxyContin overdose, said that he believed that Purdue got a free pass for years thanks to Mr. Giuliani.

“It was all because of Giuliani,” said Mr. Bisch. “And he got to take the money.”

For More Information about OxyContin Click Here

FDA Reveals Chantix Reports

2008-01-03T15:18:00.001-05:00

FDA Reveals Reports: Chantix
FDA says Chantix reports reveal suicidal thoughts and aggressive and erratic behavior.

November 20 , 2007 | FDA.gov

FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.

Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

What is Chantix? Need more information about Chantix? Click Here

Trasylol Pulled From Worldwide Market

2008-01-03T15:15:00.000-05:00

FDA says clotting drug poses increased death risk, while company says drug still has benefits.
November 5 , 2007 | Steven Reinberg | usnews.com

MONDAY, Nov. 5 (HealthDay News) -- Bayer AG suspended worldwide sales of Trasylol, a clotting drug using during heart surgery to prevent bleeding, on Monday following a request from the U.S. Food and Drug Administration to remove the drug from the American market for safety reasons.

The FDA cannot identify a patient population in which the use of Trasylol (aprotinin) outweighs the risk, Dr. John K. Jenkins, director of the FDA's Office of New Drugs, said at an early morning news conference Monday.

However, he added, "the suspension will include a slow phase-out of Trasylol from the marketplace to decrease the possibility of shortages of the alternative drugs." And he added that Bayer could continue to supply the drug if physicians can identify specific patients who would benefit from it.

"Studies have found that Trasylol can increase the risk of kidney damage compared with other drugs," Dr. Gerald Dal Pan, the FDA's director of the Office of Surveillance and Epidemiology, said during the news conference.

In 2006, he added, the FDA limited the use of Trasylol and strengthened its warnings. Subsequently, he said, studies found that Trasylol increased the risk of in-hospital death among patients undergoing cardiac bypass surgery. In addition, Dal Pan said, two studies this year found that the drug increased the long-term mortality of patients who had undergone bypass surgery.

The suspension follows news last month that a major Canadian trial of the drug was terminated because of an increase in deaths for cardiac surgery patients using it.

The trial was designed to show that Trasylol was better than other drugs in controlling bleeding, Dal Pan said. "That study was halted, because Trasylol appeared to increase the risk for death compared with two other drugs," he said.

Based on these findings, the FDA requested last week that Bayer suspend Trasylol pending further review, Dal Pan added.

In a company statement on its Web site Monday, Bayer stressed that the suspension was temporary. "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the statement said.

Heart experts said, however, that the drug's suspension came as no surprise.

"This is not really new news. It has been surfacing in the past year and a half," said Dr. W. Douglas Weaver, president-elect of the American College of Cardiology and co-director of the Heart & Vascular Institute at Henry Ford Hospital in Detroit. "Many surgeons have stopped using the drug. This won't have a huge impact, but surgeons want to know [the danger]."

The FDA plans to do a detailed review of the preliminary results from the Canadian trial before deciding whether to allow Trasylol, which it first approved in 1993, back on the U.S. market.

In the Canadian trial, called BART, an elevated 30-day and overall death risk caused the study's Data Safety Monitoring Board (DSMB) to recommend stopping patient enrollment. The trial had been set to recruit about 3,000 adults who were candidates for a variety of cardiac surgeries and were at high risk of bleeding.

A month before, on Sept. 12, an FDA advisory panel had recommended that Trasylol remain on the market, despite mounting evidence that it might have serious side effects.

In addition, in February, a study published in the Journal of the American Medical Association found patients on the drug were at greater risk of dying over the next five years than those given two other medications. The same researchers had linked the drug to an increased risk of kidney failure, heart failure and stroke in a study published in 2006.

"Our present findings deal with death," one of the JAMA study's authors, Dr. Dennis T. Mangano, said at the time. Mangano, director of the Ischemia Research and Education Foundation, a California-based nonprofit group, said that "the death rate for aprotinin patients far outstrips that for the other two drugs."

His team's study tracked the long-term survival of almost 3,900 heart patients who underwent coronary artery bypass surgery at 62 medical centers worldwide and found that the five-year death rate for patients given Trasylol was 20.8 percent, compared to 15.8 percent for those given another drug, aminocaproic acid, and 14.7 percent for those given tranexamic acid.

After the 2006 report from Mangano's group, the FDA advised doctors to carefully monitor Trasylol patients for kidney, heart and brain damage -- an action taken after Bayer itself disclosed study data showing that the drug increased the risk of death, kidney damage, congestive heart failure and stroke.

What is Trasylol? For more information visit: Trasylol

Merck profits signal a rebound

2008-01-03T15:12:00.000-05:00

The drugmaker said sales were key to overcoming Vioxx losses.
October 23 , 2007 | Karl Stark (Inquirer Staff Writer)

Merck & Co. Inc. is coming back.
Two years ago, the company was reeling from its failed pain reliever, Vioxx, and from the impending loss of one of its most profitable drugs. Analysts were openly skeptical about the company's prospects.

But yesterday, Merck reported a 62 percent rise in net income for the third quarter, fueled by a doubling of vaccine sales.

Merck, whose vaccine operations are based in West Point, Montgomery County, made more money in part because it cut marketing and administrative costs 18 percent and increased revenue 12 percent.

Driving sales were Merck's heavily marketed drugs, including its top seller, the asthma and allergy medication Singulair, and more recent additions, including the human papillomavirus vaccine Gardasil.

So far, the market has responded, driving up Merck's share price 20 percent over the last year.

Merck's return to glory is far from assured. Like its competitors, the third-largest U.S. drugmaker faces patent expirations on key products in the next few years. And the company's quarterly results improved in part because executives chose to reserve less money for Vioxx lawsuits than in the quarter a year earlier.

Merck must still contend with 26,600 lawsuits involving Vioxx, which the company pulled from the market three years ago for safety reasons.

Vioxx "is still the biggest risk," said Michael Levesque, a credit analyst and senior vice president with Moody's Investors Service.

Still, Levesque added, "they have executed on their pipelines in the last several years in a way that sets them apart from many of their peers."

The company cited the third quarter, which ended Sept. 30, as part of a trend. "The momentum that Merck began to build last year continues, as proven by the strong performance in this last quarter," chief executive officer Richard T. Clark said in a conference call with Wall Street analysts.

Sales for the quarter were $6.1 billion, up from $5.4 billion in 2006. Net income increased to $1.5 billion from $941 million. And earnings per diluted share rose to 70 cents from 43 cents.

Merck's biggest seller, Singulair, which goes off patent in 2012, saw its sales rise 17 percent to $1 billion in the quarter.

The antihypertension drugs, Cozaar and Hyzaar, reached $814 million, or about even with last year. Those patents expire in April 2010.

Another big seller, Fosamax for bone loss, chalked up $725 million in sales, representing a 6 percent drop. It goes off patent in February.

Total vaccine sales were a bright spot, rising from $555 million a year earlier to $1.2 billion. Leading the firm's vaccine sector was Gardasil, the new vaccine against the human papillomavirus, which can cause cervical cancer and genital warts. The drug accounted for $418 million for the quarter and is expected to have one of the largest markets in history for a vaccine.

Rotateq, the vaccine against rotavirus that launched in February 2006, had sales of $171 million in the third quarter. BothChildren's Hospital of Philadelphia and the nearby Wistar Institute helped develop the vaccine and receive royalties.

Eight Merck drugs have been approved by the FDA in the last two years, including six novel compounds, such as Januvia, Gardasil and the new HIV drug Isentress.

Isentress, which won approval this month, is a first-in-class treatment for HIV patients whose infections have become resistant to other drugs.

The medication could gain more than half the sales in its projected $1 billion class by 2016, said analyst Sylvia Eash of Decision Resources, a privately held firm in Waltham, Mass., that analyzes drugs for pharmaceutical and biotech firms.

On the Vioxx front, Merck put aside an additional $70 million for its legal defense, a big drop from the $598 million it reserved in last year's third quarter. The difference helped cut marketing and administrative expenses in this year's third quarter, the company said.

Merck spent $160 million on the suits in the third quarter alone. It has not put aside any money to pay verdicts, a company spokeswoman confirmed.

The company's scorecard, as of yesterday, showed 11 victories and five losses.

The five losses carry judgments totaling $102.5 million, though the company is appealing each case and has yet to pay any money.

Marc Grossman, a Long Island lawyer who is representing about 350 Vioxx plaintiffs, said Merck was "playing this denial game" and "creating the perception that their Vioxx strategy is working . . . when in fact the litigation is just beginning."

Daniel Hoffman, a pharmaceutical analyst based in Glenmore, Chester County, praised management for starting to turn around the company, but said the Vioxx cases remained a concern. "They're not out of the woods by any stretch of the imagination," he said.

Merck's stock rose $1.53, or 2.9 percent, to close at $54.64.

More Information about Vioxx here

Patients Warned as Maker Halts Sale of Heart Implant Part

2008-01-03T15:08:00.000-05:00

October 15 , 2007 | The New York Times

The nation’s largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths.

The faulty component is an electrical “lead,” or a wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm. The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data.

Such a malfunction can cause the device to either deliver an unnecessary electrical jolt or fail to provide a life-saving one to a patient in need. In most cases, the defibrillators can be reprogrammed without surgery to minimize the problem.

Medtronic estimated that about 2.3 percent of patients with the Fidelis lead, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. Those patients will require a delicate surgical procedure to replace the lead, experts said.

Medtronic said it would stop selling the lead and recall all leads not yet implanted.

Replacing leads on a heart device like a defibrillator is considered by experts to be far more dangerous than replacing the device itself. As a result, doctors said that patients were better off leaving the lead in place except in those instances where it has stopped functioning properly.

The Fidelis lead has been used with Medtronic defibrillators since 2004, and most patients who received Medtronic defibrillators since then have them. Patients who have recently had defibrillators replaced because their batteries were running down may not have the leads because doctors commonly attach replacement defibrillators to the existing leads when possible.

Vice President Dick Cheney uses a Medtronic defibrillator, but it was implanted in 2001, before the Fidelis lead was introduced. The White House declined to comment last night.

Questions about the performance of the Fidelis lead have surfaced before. For example, earlier this year, Dr. Robert G. Hauser of the Minneapolis Heart Institute published an analysis that found, among other things, that a significant number of patients were experiencing “inappropriate” shocks because their defibrillator was firing when not needed. Such jolts can be extremely painful.

Dr. Hauser, who played a central role several years ago in bringing to light malfunctions in defibrillators made by Guidant, said that he discussed his findings earlier this year with Medtronic officials, who said there was not enough data to come to any conclusions. In March, however, the company issued a letter to doctors sharing those concerns with doctors.

Last month, when 30 months of data showed a continuing fracture problem, Medtronic began talking with its independent medical advisers about what to do next. “The numbers that we saw were not that bad, but they were worrisome, troubling,” said Dr. Douglas P. Zipes, a professor at the Indiana University School of Medicine and a member of the advisory board.

Statistically speaking, there is not enough data to be sure that Fidelis is unusually prone to fracture. But with mounting evidence that there was cause for concern, Medtronic decided to act now. Five deaths have been linked to the fractures as a possible, though not confirmed, contributor.

The numbers suggesting that the problem was significant enough to halt sales of the lead come from two other sources: a clinical trial currently following the progress of 650 patients at 17 hospitals and the mountain of data collected from 25,000 patients in CareLink, Medtronic’s system for remotely monitoring implants. Medtronic said that data from fractured leads that have been returned had helped it understand where the malfunctions occur.

Federal safety regulators, who participated in the announcement yesterday, endorsed Medtronic’s decision to stop selling the lead.

“Pulling this device from the market is the right thing to do,” said Daniel G. Schultz, director of the Center for Devices and Radiological Health at the Food and Drug Administration.

The recall is the latest in a series of setbacks for Medtronic and its two main rivals in the $6 billion global defibrillator market, St. Jude Medical and Boston Scientific, which now owns Guidant. Sales have slumped in the United States in the last two years because of a string of safety recalls and concern among doctors that it is too difficult to identify which patients would benefit from the devices. They can cost $30,000 or more.

Medtronic declined to discuss the potential financial impact of its actions regarding Fidelis prior to a conference call scheduled for this morning with Wall Street analysts. The company, which had $12.3 billion in sales last year, has more than 55 percent of the defibrillator market, and the devices are its biggest product.

Medtronic will cover the cost of a replacement lead for those that have fractured, plus up to $800 in medical expenses that are not covered by insurance. But the company will not pay for procedures to replace functioning leads that patients want taken out to head off possible problems in the future, a company spokesman, Robert Clark, said.

Mr. Clark declined to comment on how many unused leads the company expected to take back and destroy. He said Medtronic would attempt to design a similarly narrow lead to replace the current products.

Medtronic is recommending that doctors switch back to its older Quattro lead, but doctors will have other options from other companies. The biggest long-term financial impact on Medtronic could come not from doctors using other leads but from the possibility that they could switch to complete defibrillator packages from other companies.

Medtronic said that none of its pacemakers used the leads. Pacemakers are device that, instead of shocking a heart back into a stable rhythm, are meany to ensure a continuous steady beat.

Medtronic developed Fidelis as part of the race among cardiac device companies to develop ever more compact and flexible products that can be implanted more easily and safely.

Whatever happens, Medtronic is hoping to contrast its response with that of Guidant three years ago, when deadly defects were discovered in some of its defibrillators. Guidant, which Boston Scientific acquired in 2006, angered doctors and regulators by failing to quickly disclose the problems.

Since then, the Heart Rhythm Society, the professional group for doctors who implant defibrillators, has developed guidelines for handling product safety problems.

Dr. Schultz at the F.D.A. said the company’s actions were an indicator of how much the industry had learned from the mistakes made in handling the Guidant malfunction. Dr. Hauser, the Guidant whistle-blower, agreed. “I think that in the old days, this lead could have continued on the market for a long time, maybe forever,” he said.

For More Information about the Medtronic Cardiac Defibrillator Sprint Fidelis Lead Recall go here: Medtronic

Renewed call to ban Avandia

2008-01-03T14:53:00.000-05:00

September 17, 2007 | NewsDay

A consumer watchdog group stands by its belief that Avandia, the embattled type 2 diabetes drug, should be removed from the market, a demand the group's leadership says was fortified last week by additional research.

Avandia, made by GlaxoSmithKline, is designed to lower glucose in the blood, but it has been under a spotlight - and on the hot seat - for months, along with rival drug Actos, manufactured by Takeda Pharmaceutical Co.

Studies reported last week confirmed earlier ones demonstrating that the drugs raise the risk of congestive heart failure and that Avandia also raises the likelihood of heart attack and stroke.

"We've been pushing for a ban on Avandia for a while," said Dr. Peter Lurie of Public Citizen's Health Research Group. "Our angle has always been about the risk of congestive heart failure and that's what the latest study shows. We think the new research amplifies the case for removing Avandia from the market."

The evidence so far does not suggest that Actos should be banned, Lurie added, but he underscored that because it carries risks, it should not be used as first-line therapy.

Dr. Leonid Poretsky, an endocrinologist at Beth Israel Medical Center in Manhattan, said Avandia excels in controlling blood sugar. "The public has to realize that there is a risk with taking any medication. The benefits of a drug sometimes outweigh the risks."

Lurie thinks differently. "Does the overall risk-benefit of Avandia support it remaining on the market?" he asked. "We believe the answer is no."

Dr. Daniel Solomon, a professor of medicine at Harvard Medical School who critiqued the Actos and Avandia studies in last week's Journal of the American Medical Association, said the drugs belong to the class of medications known as the thiazolidinediones.

Solomon said the drug family is extraordinarily complex and affects numerous biological pathways. It's likely that not all the side effects are known.

He likened problems linked to Avandia and Actos to those involving Vioxx, the painkiller voluntarily pulled from the market in 2003 by Merck & Co.. Vioxx, a so-called COX-2 inhibitor, also elevated the risk of heart attacks and strokes.

Problems with Avandia and Actos, Solomon said, came into sharper focus once they were widely prescribed. Pre-clinical tests indicated that they raised the risk of congestive heart failure, he added, but it took years for that concern to register with the public. Both drugs were approved by the Food and Drug Administration in 1999.

"It really calls into question the drug safety process," Solomon said. "Concerns are raised but it takes several years before we have enough information to understand all of the safety issues. ... Everyone should be asking whether there is a way to create a drug safety-monitoring system so that concerns can be brought to the fore more quickly."

As of August, Avandia and Actos have carried "black box" warnings, the FDA's most stringent level of caution.

Executives at Takeda said last week that Actos is safe. And Mary Anne Rhyne, spokeswoman for GlaxoSmithKline, insisted Friday that Avandia is as well. "We stand firmly behind the medication when it is used appropriately," she said.

However, alternative-medicine physicians on Long Island are giving Avandia and Actos to children with autism under the unproven theory that it effectively treats the disorder. And a GlaxoSmithKline-sponsored clinical trial is under way testing Avandia in patients with Alzheimer's disease. Rhyne said patient's in that study are being closely monitored.

Lurie noted that in addition to cardiovascular risks, Avandia and Actos also increase the chances of bone fractures and vision impairment.

What is Avandia? Need more information about Avandia? Click Here

Family plans to sue Adventureland after tot's injury

2008-01-03T14:49:00.000-05:00

Augustuly 15, 07 9:50 PM | NewsDay

Days after a 6-year-old boy's hand was mangled at Adventureland in Farmingdale, his family is planning to sue the park, their attorney said Wednesday.

Charlie DeMarco of Bellmore lost his balance on the Super Raider, a walk-through attraction, at about 2:30 p.m. Saturday, said attorney David Woycik of Mineola. He fell on a portion of the it where kids cross an elevated walkway of moving metal plates and ended up with his hand stuck between one of the horizontal plates and a vertical wall on the side of the ride, Woycik said.

Charlie was at the park with his mother and sister, who immediately rushed to his aid and yanked his bloodied hand from the crevice, Woycik said. Skin was ripped to the bone in spots along the side of the boy's hand in what Woycik called a "degloving injury" where the skin was stripped off, and for now, he has lost mobility.

"She was horrified, the mother," Woycik said. She did not respond to requests for comment.

Woycik said the Adventureland staff was not fast enough in responding to the accident, and that the injury might have been prevented if the ride was properly supervised. "A fun day at the amusement park and you don't expect your son's hand to be mangled, he said.

But Paul Gentile, the park's operations manager, said only a minute elapsed before the boy was tended to, and the boy's family even thanked him for Adventureland's response.

The boy's injury comes about two years after two people were killed in the same week at the park. In September 2005, an 18-year-old Adventureland worker died after he was run over by the roller coaster he was operating. Two days later, a 45-year-old woman was thrown from a ride and died after her body slammed into a car in the Adventureland parking lot.

The Super Raider was still open as of Wednesday afternoon, with a short line of small children antsy to enter.

Gentile said thousands of children have been on the Super Raider for years without incident and said he saw no need to shut the ride down.

He said the ride would be reviewed. "I wouldn't call it a problem," he said. "People get injured on various rides in the park. He's just a child who lost his balance and injured his hand."

There have been other injuries on the ride this year, Gentile said, but he could not be specific.

One Adventureland patron said Wednesday the park may not have been vigilant enough.

"Wow," said Peggy Burke, who sat on a ledge at Super Raider Wednesday waiting for her 9-year-old and 11-year-old granddaughters to exit. "I was just saying to my husband I have heard about accidents happening here. They should have shut it down for a few days at least and taken a look at the problem."

For More Information about this lawsuit visit: Personal Injury News

OxyContin Makers Admit Deception

2008-01-03T14:44:00.000-05:00

OxyContin Makers Admit Deception - addiction danger from painkiller was understated

By Carrie Johnson, Staff Writer
FRIDAY, May. 11 2007 (Washington Post) --
OxyContin Makers Admit Deception
Addiction Danger From Painkiller Was Understated

The manufacturer of the potent painkiller OxyContin and three current and former executives at the company yesterday pleaded guilty to falsely marketing the drug in a way that played down its addictive properties and led to scores of people becoming addicted, prosecutors said.

The Purdue Frederick Co. and its chief executive, top lawyer, and former medical chief agreed to pay a total of $635 million to resolve charges filed by the U.S. attorney in the Western District of Virginia, who called OxyContin "one of our nation's greatest prescription-drug failures."

"Even in the face of warnings from health-care professionals, the media and members of its own sales force . . . Purdue continued to push a fraudulent marketing campaign," U.S. Attorney John L. Brownlee said.

The drugmaker knew as early as 1995 that health professionals feared the addictive potential of OxyContin, an opium derivative, but looked the other way, according to court papers. From 1996 to 2001, Purdue claimed that the "miracle drug" was safer than rival medications despite repeated studies that suggested patients had developed a risk of abuse and had serious trouble withdrawing from OxyContin. Purdue collected $2.8 billion through sales of OxyContin during that time, court papers said.

In one instance, supervisors decided against sharing information about difficult OxyContin withdrawal out of fear that it would "add to the current negative press," according to documents presented in an Abingdon, Va., courtroom yesterday.

"Purdue put its desire to sell OxyContin above the interests of the public," Assistant U.S. Attorney General Peter D. Keisler said.

OxyContin, the trade name for oxycodone, is a time-released pill that when crushed and ingested gives users a powerful high. The medication was designed as a less dangerous alternative to morphine for people with cancer and chronic pain. But it has proved deadly for consumers and vexing for law enforcement officials, who bemoan the rise in home burglaries and pharmacy break-ins connected to the spread of a drug sometimes called "hillbilly heroin."

In a 2002 report, the Drug Enforcement Administration traced 142 deaths to OxyContin overdose and said the drug contributed to another 318 fatalities. The DEA said the number of deaths related to the substance rose 400 percent from 1996 to 2001.

Under the terms of the plea deal, Purdue pleaded guilty to a single felony count and agreed to pay $470 million to the government and $130 million more to settle civil claims over injuries and deaths. Virginia will receive nearly $5.3 million to fund health-care fraud investigations and $20 million to fund a prescription drug monitoring program.

Purdue chief executive Michael Friedman, chief legal officer Howard R. Udell and former head of research Paul D. Goldenheim each pleaded guilty to one misdemeanor charge. The men, who will not serve prison time, together will pay about $35 million under the terms of the agreement. Friedman and Udell remain with the company, which is based in Stamford, Conn., while Goldenheim works with health-care start-up businesses, Purdue said.

In a statement, Purdue distanced the executives from the fraudulent marketing messages disseminated to thousands of physicians and pharmacies over the past decade. The company said that the men admitted guilt under a legal principle that holds high-level officials accountable for the improper acts of others at a drug company.

The current and former officials who pleaded guilty "neither engaged in nor tolerated the misconduct at issue in this investigation," the statement said. "To the contrary, they took steps to prevent any misstatements in the marketing or promotion of OxyContin and to correct any such misstatements of which they became aware."

Legal experts said proving that drug company officials intended to deceive consumers is a difficult burden for the government. But one health-care advocate criticized the settlement as toothless, given the estimated $9.6 billion in OxyContin sales between 2000 and last year.

Sidney M. Wolfe, director of Public Citizen's Health Research Group, said in a written statement that the government should have pressed Purdue to forfeit more money it made off the drug.

"Why have the three wealthy Purdue executives, who have pleaded guilty to orchestrating this dangerous promotional campaign, escaped jail time and why are they paying merely $34.5 million in penalties?" Wolfe said.

Since 2002, Purdue has been a client of Giuliani Partners, the consulting firm headed by former New York City mayor and Republican presidential candidate Rudolph W. Giuliani. Giuliani, who was one of Purdue's lawyers in the case through his law firm, Bracewell & Giuliani, met with government lawyers more than half a dozen times and helped strike an agreement in principle to settle the case in October, people involved in the case said.

The crackdown on abuse of OxyContin was on display earlier this year at the courthouse in Alexandria, where prominent pain doctor William E. Hurwitz was convicted on drug-trafficking charges.

Hurwitz, a major figure in the growing field of pain management who was once profiled on "60 Minutes,'' was convicted on 16 counts of drug trafficking. Prosecutors contended that Hurwitz prescribed excessive amounts of oxycodone and other dangerous narcotics -- in one instance more than 1,600 pills a day -- to addicts and others, some of whom then sold the medication on a lucrative black market.

That case is part of an ongoing investigation into doctors, pharmacists and patients suspected of selling potent narcotics and fueling an epidemic that ravaged Appalachia and triggered other crimes.
Oxycontin (Generic: Oxycodone hci) has been linked to physical dependence and addiction. Oxycontin contains a narcotic similar to morphine and has been prescribed to treat pain in cases of arthritis, back pain, and cancer. Oxycontin was first introduced in December 1995. It belongs to the drug class known as opioid agonists and is categorized as a Schedule II controlled substance.

The active ingredient in Oxycontin is oxycodone, a substance found in many different pain medications. However, most other pain medications contain small amounts of oxycodone. Oxycontin is a time-release formula that contains a significantly greater amount of oxycodone. Oxycontin is both one of the best selling prescription medications and one of the most abused drugs in history.

Oxycontin is indicated for the management of moderate to severe pain. A disturbing amount of reports have surfaced detailing widespread addiction to the drug from patients who were prescribed the drug as well as people obtaining the drug through illegal channels. Oxycontin has been linked to over a hundred deaths. Its high and addiction have been compared to those of heroin. The devastation associated with Oxycontin includes armed robberies, criminal indictments of doctors, individual and state lawsuits against Purdue Pharma, and concern from the DEA and FDA. The DEA has asked Purdue Pharma to change its strategy regarding Oxycontin. These suggestions included: marketing Oxycontin only to pain specialists, omit the claim that Oxycontin is less subject to abuse than other narcotics, and reformulation of the drug.

On July 25, 2001, at the urging of the FDA, Purdue Pharma added new warnings to Oxycontin. Oxycontin will bear the FDA’s strongest type of warning, a black box, stating that Oxycontin is potentially as addictive as morphine. Purdue Pharma sent out letters to doctors asking them to only prescribe Oxycontin for severe pain. However, Purdue Pharma still asserts that there is no problem with Oxycontin. On August 9, 2001, Purdue Pharma announced that it is working on patent application for a new formula of Oxycontin, hoping to make it less susceptible to abuse and addiction. In the meantime, the amount of crime and number of deaths attributed to Oxycontin continue to rise.

What is OxyContin? Need More Information? Click Here: OxyContin Information

First Fosamax Case Brought in New Jersey Sanders Viener Grossman, LLP

2008-01-03T14:31:00.000-05:00

May 23, 2006 (Mineola, New York) Mineola firm files the first suit against Merck & Co., Inc.'s (NYSE: MRK) in Superior Court of the State of New Jersey, Atlantic County, on behalf of a retired 77-year old Married Man from Smithtown, New York, who was recently diagnosed with Osteonecrosis of the jaw (ONJ).

Mr. Rhys Wass began taking Fosamax in 1996 and took 70 mg once a week for almost 10 years until this April when he was advised by Long Island Jewish Hospital that a biopsy revealed dead bone in his jaw. His Oral Surgeon advised Mr. Wass that this horrific injury was the result of his taking the controversial drug Fosamax. Until then, Mr. Wass had no idea what was causing him to have severe oral infections which started in January 2006 when he had a tooth removed. Since then, his condition has deteriorated to the point that he can barely speak or eat.

Mr. Wass is exploring all available options but there is no easy remedy for this debilitating condition. It is alleged that Merck, who is still reeling over the Vioxx scandal, knew of the dangers of Fosamax and nevertheless put profits over people (once again) causing harm to thousands of innocent Fosamax users.

According to Attorneys Meryl Sanders Viener and Marc D. Grossman, Fosamax victims were not made aware of the risks associated with getting routine dental procedures despite Merck knowing that these people were more likely to have complications and an increased likelihood of severe jaw injuries. And they should know, having already sued Merck on behalf of hundreds of Vioxx victims in this very same courthouse and being quite familiar with the deceptive tactics and disregard Merck has shown for human life in order to sell their products.

The big question remains: Why didn’t Merck at least notify the dental community of these risks? A recent breaking news story in the Wall Street Journal reported claims that Merck, the manufacturer of Fosamax, sold and heavily marketed the drug as safe, despite knowing about its dangerous side effects. Additionally, the article reported that Merck failed to timely change its label to reflect the risk of its product.

What is Fosamax? Need more information? Click here: Fosamax Information

Personal Injury Blog Opened

2008-01-03T14:23:00.000-05:00

New York Personal Injury Blog provided by Sanders, Sanders, Block, Woycik, Viener & Grossman, P.C. a New York Personal Injury Law Firm. More information about The Sanders Law Firm is available here: More Information .

I created this blog a little while ago but I haven't had the chance to post anything in it. However, to start of with some content and essential personal injury information and news I'll post a few key publications in the Personal Injury world today.

On another note: happy new years, have a wonderful, prosperous, wealthy and most importantly health new year.