Lilly takes $1.4B charge related to investigation

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Posted on 21st October 2008 by Gordon Johnson in Uncategorized

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Date: 10/21/2008 10:31 AM

By TOM MURPHY
AP Business Writer

INDIANAPOLIS (AP) _ Eli Lilly and Co. will take a big bite out of its third-quarter earnings with a $1.4 billion charge related to a government investigation over marketing practices for the anti-psychotic Zyprexa.

The drug maker said Tuesday it would take a charge that equates to $1.29 per share because it was in advanced discussions with the U.S. Attorney’s Office for the Eastern District of Pennsylvania over U.S. marketing and promotional practices for the drug.

But a Lilly representative also cautioned that the company isn’t admitting it did anything wrong in selling the anti-psychotic, its top revenue producer.

“All we’re doing today is taking a charge to earnings, so there is no admission or settlement or anything beyond that,” spokeswoman Marni Lemons said. “We are in advanced discussions with the government, but we have not concluded those discussions, and they could take more time.”

Patty Hartman, a spokeswoman for the U.S. attorney’s office, declined to comment on Lilly’s announcement.

“We’re aware that Lilly has released the information to the public, and it’s premature for us to comment about any disclosure,” she said.

The U.S. attorney’s office launched its investigation in 2004, and Lilly received a grand jury subpoena for a range of documents late last year. Lemons said the investigation has been a distraction.

“Our primary motivation is to put this issue behind us and get back to focusing on providing medications for patients, caregivers and health care professionals,” she said.

The charge surpasses Lilly’s entire profit for last year’s third quarter, when the drug maker reported net income of $926.3 million, or 85 cents a share. Lilly shares rose 5 percent Monday to close at $34.10, but the stock price fell 50 cents to $33.60 in Tuesday morning trading.

Analysts generally will exclude this charge from their earnings calculations for Lilly, analyst Les Funtleyder of Miller Tabak and Co. said.

“I think Wall Street will understand it’s a one-time event, and maybe a positive at that, because we’ll get past it,” he said.

Zyprexa has been Lilly’s top-selling drug for years and brought in $4.7 billion in revenue last year. But it also has been the subject of reams of litigation.

Lilly has settled more than 31,000 product-liability claims against the drug since 2005, shelling out more than $1.1 billion in the process.

Earlier this month, Lilly announced a separate $62 million settlement with 32 states and Washington, D.C., over marketing practices.

Lilly paid $15 million to settle a lawsuit with the state of Alaska in March. The drug maker still faces litigation with 11 states, generally involving consumer protection issues or Medicaid reimbursement.

But Lemons said some of those cases may be affected by settlement talks with the U.S. attorney’s office.

A group of insurance companies, unions and others are suing Lilly for billions of dollars, saying the drug maker charged too much for Zyprexa and marketed the drug for off-label uses. A federal judge has recommended that Lilly settle that case and last month granted the plaintiffs class-action status.

Aside from that case, Lilly still faces lawsuits from about 1,600 plaintiffs, Lemons said.

Lilly is scheduled to report its third-quarter earnings Thursdsay.

Copyright 2008 The Associated Press.

Safety a problem for new generation drugs, too

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Posted on 21st October 2008 by Gordon Johnson in Uncategorized

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Date: 10/21/2008 10:00 AM

By LINDSEY TANNER
AP Medical Writer

CHICAGO (AP) _ Nearly a fourth of widely used new-generation biological drugs that treat several common diseases produce serious side effects that lead to safety warnings soon after they go on the market, the first major study of its kind found.

Included in the report released Tuesday were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All wound up being flagged for safety.

That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.

Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007.

Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs.

The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.

The new drugs are known as biologicals because they’re made from living material and often work by triggering the body’s disease-fighting immune response.

It’s that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, including major infections and cancer, said Dr. Charles Bennett, a Northwestern University drug safety expert. He was not involved in the research.

Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows that’s not necessarily true.

“They have an important role,” Bennett said. “They’re really the next generation of pharmaceuticals.”

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

Among the drugs under examination are Genentech Inc.’s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.

The study appears in Wednesday’s Journal of the American Medical Association.

It involved 136 biologics approved in the United States and 105 in the European Union between January 1995 and June 2007. A total of 41, or nearly 24 percent, got safety warnings issued through June 2008.

The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.

But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.

“If most issues are discovered within the first few years, then the system is working,” Giezen said.

Bennett says it’s unreasonable to think that the studied drugs’ safety issues should have been discovered before they were marketed. That’s because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.

Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices.

For example, non-steroid arthritis medicines including ibuprofen can reduce pain by decreasing inflammation, but they can cause stomach bleeding.

Biologic rheumatoid arthritis medicines Remicade, Enbrel and Humira are designed to ease painful joints by keeping the body’s immune system from attacking itself, the underlying problem in the disease. But they are much more expensive and have been linked with higher risks for potentially fatal infections. Also, the FDA is investigating possible cancer risks.

“My message to patients is that these biological products often can treat very difficult to treat diseases but may have very substantial risks and that you need to take extra care to educate yourself as to what those risks might be,” Moore said.

____

On the Net:

JAMA: http://jama.ama-assn.org

Copyright 2008 The Associated Press.

Australia recalls products in tainted milk scandal

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Posted on 20th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/19/2008 11:30 PM

SYDNEY, Australia (AP) _ Australian officials ordered the recall of a milk drink and cake brand after tests showed they were contaminated with melamine, bringing to six the number of Chinese-made products withdrawn in Australia following China’s tainted milk scandal.

A spokeswoman for Food Standards Australia New Zealand said Monday that Orion brand Tiramisu Italian Cake with Cheese Cream and Dali Yuan brand First Milk vanilla-flavored drink were recalled Friday after government tests revealed the Chinese-made products contained low levels of melamine, the industrial chemical that has sickened tens of thousands of Chinese children.

A sample of the cakes was found to contain 4.4 parts per million of melamine, while the milk drink had 5.8 ppm, Food Standards spokeswoman Lydia Buchtmann said. The agency has set the safe limit at 2.5 ppm.

The other products previously recalled in Australia are Kirin Milk Tea, Lotte Koala Biscuits, Cadbury Eclairs and White Rabbit candies.

Milk powder contaminated with melamine has been blamed for the deaths of four infants and for sickening about 54,000 others in mainland China. Hong Kong has also found 10 children with kidney stones who had consumed Chinese-made milk products.

Melamine is used in the manufacturing of plastics, fertilizer, paint and adhesives. Health experts say ingesting a small amount poses no danger, but in larger doses, the chemical can cause kidney stones and lead to kidney failure.

Copyright 2008 The Associated Press.

$894 million deal ends pain of Pfizer's lawsuits

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Posted on 17th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/17/2008 9:47 AM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ Drug giant Pfizer Inc. has reached an $894 million deal to end most of the lawsuits over its two prescription pain relievers, the popular Celebrex and a similar drug, Bextra, no longer on the market.

The world’s biggest drugmaker said Friday it has agreements in principle to end more than 90 percent of personal injury lawsuits brought by people claiming the pills caused heart attacks, strokes or other harm.

The settlement includes roughly 7,000 personal injury cases, mainly plaintiffs who took since-withdrawn Bextra, said plaintiff attorney Perry Weitz. He represents nearly 2,000 claimants, about 10 percent of them relatives of people who died.

“It gives Pfizer closure and the claimants their money sooner, rather than later or never at all,” Weitz said.

Pfizer hopes to finalize claims covered by the settlement, which now includes up to 92 percent of plaintiffs, by year’s end. It also hopes to include many of the remaining claimants in the settlement and will fight any remaining personal injury suits with court motions or at trial, General Counsel Amy Schulman told The Associated Press.

“I don’t think either side has an interest in protracting this,” Schulman said in an interview.

Weitz said plaintiff lawyers will “have issues” with Pfizer “if their claimants aren’t paid before the end of the year.”

In early trading, Pfizer shares were down 47 cents, or 2.8 percent, at $16.50.

Schulman said the deal comes after two important court rulings — one by a New York state judge overseeing many of the state-level personal injury cases and the other by a federal judge in San Francisco coordinating pretrial steps in federal lawsuits over the drugs.

“We teed up some pretrial motions for a court ruling on whether there was significantly reliable evidence that would allow an expert to testify as to whether there was an increased risk of heart attack and stroke at the most common dose,” 200 milligrams, Schulman said. Both judges ruled that was not the case, she said.

The proposed deal also would end suits by insurers and patients seeking to recover what they spent on Bextra and Celebrex, as well as claims by 33 states and the District of Columbia that Pfizer improperly promoted Bextra.

Out of the total settlement, $745 million will go to settle personal injury cases, $60 million will cover settlements with attorneys general in the 33 states and the District of Columbia, and $89 million will cover consumer fraud class action cases over reimbursement for money spent on the two drugs. Two additional states, Louisiana and Mississippi, still have pending cases regarding Pfizer’s promotion of the drugs.

New York-based Pfizer withdrew Bextra from the market in 2005, a year after Merck & Co. withdrew its Vioxx, a similar drug.

The Vioxx withdrawal, which triggered an avalanche of lawsuits against Merck, also raised concerns about the safety of other medicines in the same class, called Cox-2 inhibitors. They were heavily touted by their makers as superior to traditional nonsteroidal anti-inflammatory drugs, or NSAIDs, such as ibuprofen, because they block an enzyme involved in promoting inflammation but — unlike NSAIDs — don’t block an enzyme that protects the stomach from bleeding and other side effects.

Other NSAIDs, such as ibuprofen and naproxen, have also been linked to increased heart risks.

Celebrex is the only Cox-2 inhibitor that the Food and Drug Administration has allowed to remain on the U.S. market.

Attorney Christopher Seeger, a member of the plaintiffs steering committee, said he’ll “have no problem recommending” the settlement to the roughly 400 clients he represents.

“We’re very satisfied with the deal,” Seeger said.

Schulman said the company’s negotiations with opposing lawyers had been under way for some time but picked up in the late summer.

“Litigation can be distracting, and putting these matters behind us helps our shareholders and, most importantly, patients and doctors,” Schulman said.

Weitz noted that it took four or five years to get through trials for less than 20 cases in the massive Vioxx litigation, because the court system can only handle a limited number of cases at a time.

Pfizer will take a pretax charge of $894 million to its third-quarter earnings, which it is scheduled to report on Tuesday.

Merck, based in Whitehouse Station, N.J., has begun paying a $4.85 billion settlement to end about 50,000 lawsuits brought by people claiming Vioxx cause heart attacks, ischemic strokes or death. It still faces other litigation over the former blockbuster arthritis treatment.

Copyright 2008 The Associated Press.

FDA seeks advice to improve tracking of produce

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Posted on 17th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/16/2008 4:16 PM

By KEVIN FREKING
Associated Press Writer

WASHINGTON (AP) _ Prompted by this summer’s salmonella outbreak, the government has begun investigating how to quickly identify the source of contaminated food and stop it from getting to consumers.

At the first public hearing on the issue Thursday, representatives from the produce industry cited progress toward labeling on every case of fruit and vegetables that would make it easier to trace tainted food from the dinner table back to the farm.

Consumer advocates want more: marking individual tomatoes, heads of lettuce and other produce from an industry subject to 900 safety recalls over the past two years.

“We need better information going to the consumer so he can identify fruits and vegetables when it’s in his refrigerator and in his cabinet shelves,” said David Plunkett, senior staff attorney at the Center for Science in the Public Interest.

The salmonella outbreak that sickened at least 1,440 people exposed flaws in the nation’s food safety system. Government investigators found strong evidence to implicate jalapeno and serrano peppers, and a farm in Mexico, in the largest outbreak of foodborne illness in a decade. An earlier warning advised people against eating various kinds of tomatoes.

The Food and Drug Administration has asked companies and consumers to recommend ways to improve the tracing of produce throughout the distribution system. Agency officials said the large number of food recalls and food-borne illnesses of recent years is a sign that health officials are better at finding problems.

“We are going to see more of these (outbreaks) rather than fewer,” said Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition. “We just need to respond sooner when they do occur.”

One of the questions the FDA is asking is whether an identifier should be assigned to fresh produce, and if so, at what stage in the supply chain. The industry agrees with that concept, said Kathy Means of the Produce Marketing Association. She said it is in the industry’s best interest to quickly track problems.

“They have every incentive to want to do this,” Means said.

Means said each container of produce should contain a label with a bar code that would allow businesses and the FDA to immediately identify the owner of that product — from manufacturers to packers to retailers. She said individual companies have their own system for tracking products, but the system is not uniform. She also urged the agency to let the industry enact its plan rather than seek new federal rules. Some companies are ready to put in place the barcode system immediately while others have a long way to go.

“This is going to be hundreds of millions of dollars over a few years,” she said.

Some legal underpinnings for a national tracing system are in place.

A federal bioterrorism law requires food to be traced one step forward and one step back — who supplied it, and where it went — so that, in theory, regulators can follow the trail. Industry officials said they believed that law was sufficient to get companies to enact the kind of record keeping that would keep them in compliance with the law, but so far, they have heard of little enforcement by the government to ensure that companies were complying.

Sundlof said the law authorized the FDA to check whether businesses were complying only when health dangers had surfaced. He said on a few occasions this year when potential health problems were identified, the agency exercised its authority

___

On the Net:

Food and Drug Administration: http://www.fda.gov

Produce Marketing Association: http://www.pma.com/

Copyright 2008 The Associated Press.

Chinese government summons major dairy companies

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Posted on 17th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/17/2008 7:35 AM

By HENRY SANDERSON
Associated Press Writer

BEIJING (AP) _ China summoned five of its major dairy companies to a meeting Friday over the fate of Sanlu Group Co., the company at the center of a tainted milk scandal that has sickened thousands and led to the deaths of four children, state media reported.

The five companies were brought to Beijing to discuss the purchase of the company, the 21st Century Business Herald, a major business daily, reported Friday.

The government is trying to revive its dairy industry and contain the fallout after baby formula contaminated with melamine was blamed for the deaths of four infants and the sickening of about 54,000 other children in China.

The Health Ministry said Wednesday that 5,800 children were still hospitalized — six of them in serious condition. In Hong Kong, the Department of Health said Friday two more children have developed kidney stones after drinking melamine-laced milk, bringing to 10 the total number of children with milk-related kidney stones.

Sanlu, a majority state-owned company whose products were the most heavily tainted, is now largely defunct, with companies looking to scoop up its assets. It is 43 percent-owned by New Zealand’s Fonterra Group dairy.

The companies invited to the meeting were Chinese beverage-maker Wahaha Group, Wondersun, Inner Mongolia Yili Industrial Group Co., Sanyuan Foods Ltd. and Heilongjiang-based Feihe Dairy, which is a wholly owned subsidiary of New York-listed American Dairy Inc.

Both Sanyuan and Wahaha have been discussed in state media as likely buyers of Sanlu’s assets, but the paper also quoted Wondersun’s board chairman as saying they were considering it. But any buyer would have to take on Sanlu’s debt and the possibility of compensation to consumers, the paper said.

Jin Biao, vice president at Yili, confirmed that a meeting was called by the government but said the main focus was on how to improve the management of Sanlu’s milk collection stations and how to deal with the company’s capital. He said Yili had sent a representative.

“It is too early now to talk about the acquisition,” he said in a telephone interview with The Associated Press.

Lianfang Chen, an analyst at Beijing Orient Agribusiness Consultant Co., said the meeting would discuss resuming milk production at Sanlu’s factories, keeping its workers employed, and also resume buying raw milk to keep farmers employed.

“Though Sanlu does not have any value as a brand, its processing facility, raw milk bases, production capacity and experienced workers and managerial expertise still have great value. That’s what makes a selling point,” Chen said.

Fonterra chief executive Andrew Ferrier said Friday that discussions continuing around Sanlu “include the possibility of Sanlu being acquired by a third party,” and Fonterra is involved in a number of the discussions.

But he said the long-term future of Sanlu “and Fonterra’s stake in the company” remained uncertain. Fonterra wrote down $85 million of its stake last month, but has retained on its books an estimated $38 million worth of its investment.

A spokesman for Fonterra said they did not send anyone to the meeting but expect to be briefed by representatives of Sanlu, who are taking part.

______

Associated Press Writer Ray Lilley in Wellington, New Zealand, contributed to this article.

Copyright 2008 The Associated Press.
Summary

Daiichi Sankyo, Eli Lilly: New drug still on track

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Posted on 17th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/17/2008 2:03 AM

By TOMOKO A. HOSAKA
Associated Press Writer

TOKYO (AP) _ Japanese drug maker Daiichi Sankyo Co. and U.S. partner Eli Lilly & Co. sought to reassure investors Friday that a highly anticipated blood thinner remains on track for approval, despite escalating concerns of further delays by federal health regulators.

Wall Street has big hopes for the potential blockbuster medication, called prasugrel, but its enthusiasm was dampened in late September, when the Food and Drug Administration postponed its decision for a second time. Recent media reports speculate that additional FDA meetings may push back the ruling until March.

In a joint statement, the companies said they had not been contacted regarding any regulatory action or advisory committee review of the drug.

“Daiichi Sankyo and Lilly are engaged in an ongoing dialogue with the FDA,” said Jennifer Stotka, a Lilly vice president. “We remain confident in the overall benefit-risk profile of prasugrel, and we believe this drug should be approved so that we can bring this valuable treatment option to (acute coronary syndromes) patients, a population at risk for further cardiovascular events.”

Prasugrel, codeveloped with Daiichi Sankyo, is designed to treat patients with acute heart problems such as heart attacks or unstable angina who are at risk of developing blood clots.

The drug’s approval is key for Lilly’s financial outlook, as the patent on its best-selling drug, the anti-psychotic Zyprexa, is due to expire in 2011.

Prasugrel would compete against the blockbuster blood thinner Plavix, which loses patent protection in 2011 and is made by Sanofi-Aventis SA and Bristol-Myers Squibb Co.

A head-to-head study released last year showed that fewer patients taking prasugrel developed blood clots in stents or suffered heart attacks, strokes or heart-related deaths when compared with patients taking Plavix.

However, the study also showed that major bleeding occurred in a higher percentage of patients taking prasugrel.

In a separate statement Friday, Daiichi Sankyo said it has settled payment for 20 percent of Ranbaxy Laboratories Ltd. as part of a deal to buy a controlling stake in India’s largest drug maker.

Daiichi Sankyo said it bought 92.5 million shares of the major generic drug maker for 68.19 billion rupees, or $1.4 billion.

By adding Ranbaxy’s network, Japan’s third-largest drug maker will more than double its global reach from 21 countries to 56 and expand its business into generic drug production and sales.

In trading Friday, Daiichi Sankyo’s stock fell 2.4 percent to 1,882 yen.

___

AP Business Writer Tom Murphy in Indianapolis contributed to this report.

Copyright 2008 The Associated Press.

China blames tainted ginseng injection in 3 deaths

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Posted on 14th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/14/2008

BEIJING (AP) — A ginseng injection contaminated by bacteria caused the deaths of three people using the medicine to treat thrombosis and heart disease, state media reported Tuesday.

Tests on samples of an herbal injection showed the product had been “tainted by bacteria,” the State Food and Drug Administration and Ministry of Health said in a joint statement issued Tuesday, according to the official Xinhua News Agency.

The injection sickened six people in southwestern Yunnan Province. Three of the patients died in the hospital and the others remained under observation.

The statement did not identify the type of bacteria, and only said the investigation in continuing into how the contamination took place.

The medication is an extract from the herb Ciwujia, a type of Siberian ginseng, which is injected into patients who suffer from thrombosis and heart disease.

On Monday, the drug safety agency ordered the drug’s producer, Wandashan Pharmaceutical Company in northeastern Heilongjiang Province, to recall all of its Ciwujia injection products.

China’s pharmaceutical industry is highly lucrative but poorly regulated, resulting in companies trying to cash in by substituting fake or substandard ingredients. In recent years, a string of fatalities blamed on counterfeit or shoddily made medications have been reported.

The troubles also extend to regulatory bodies. Last year, amid an uproar over the safety of Chinese exports, the country’s former top drug regulator was executed for taking millions of dollars in bribes to approve substandard medicines, including an antibiotic that killed at least 10 people.

Copyright 2008 The Associated Press.

Settlement to be argued in big pet food case

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Posted on 14th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/14/2008 5:08 AM

By GEOFF MULVIHILL
Associated Press Writer

MOUNT LAUREL, N.J. (AP) _ Thousands of pet owners whose dogs and cats died last year after eating contaminated pet food traced to China could be close to a $32 million settlement.

A federal judge in Camden was to hear oral arguments on the final proposal Tuesday. The court also will consider any filed objections.

The settlement allows pet owners to apply for expenses associated with deaths and illnesses, including the costs of veterinarians, time missed from work to care for sick animals, replacement pets, burial expenses and even property damaged because animals got sick.

In addition to the $8 million they had already agreed to pay owners of sickened pets, the pet food companies would put up $24 million for the settlement.

The case began in March 2007, when companies that make or sell pet food — including Menu Foods Income Fund, which makes dog and cat food under about 90 brand names from its base in Streetsville, Ontario — agreed to settle lawsuits with pet owners.

The U.S. Food and Drug Administration later found that the food contained melamine, a chemical used to make plastics. The chemical was traced to contaminated wheat gluten imported from China.

In April, lawyers for representing plaintiffs and dozens of companies announced they had struck a deal for pet owners in the United States and Canada.

Under the terms, even those who did not keep any receipts for either the pet food or the costs of the pets’ illness and death could get up to $900 per animal.

If any money is left after all plaintiffs are paid, it would go to animal-welfare charities.

But the agreement did not include any money for the humans’ pain and suffering from injuries to their pets. That has upset some pet owners.

One, Donna Elliott, of Fries, Va., for instance, sent U.S. District Judge Noel Hillman a picture of her late boxer, Abby.

“How do you answer the statement on the claim form, what was the value of your pet?” she asked. “My companion was everything in the world to me.”

In one court filing, the parties that struck the settlement explained: “This settlement does not pretend to do what it cannot — which is to make people fully whole for their incomprehensible losses,” the filing said. “The settlement is, however, a reflection of strenuous efforts to secure the maximum economic relief available.”

As of Sept. 30, more than 9,500 people in the United States and Canada had made claims, while just over 100 people had preserved their rights to sue separately. Relatively few — 28 — had filed objections to the settlement.

___

On the Net:

Claim information: http://www.petfoodsettlement.com

Copyright 2008 The Associated Press.

Study: Vioxx risk lingered after use of painkiller

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Posted on 13th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/13/2008 8:04 PM

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) _ A doubled risk of heart attack, stroke and death persisted at least a year after people stopped taking withdrawn painkiller Vioxx, according to an analysis of long-term data from the study that led drugmaker Merck & Co. to stop selling the drug.

The analysis, published online Tuesday by the British medical journal The Lancet, also appears to show the higher risk started soon after patients began taking Vioxx, though the study notes a small sample size precludes a definitive finding on this issue.

Doctors critical of Merck and its reporting of Vioxx studies have long argued increased cardiovascular risks from the former blockbuster arthritis drug started after just a few months’ use and persisted after use ended.

Merck continues to insist cardiac risks didn’t increase until people took Vioxx for about 18 months — a cornerstone of its strategy to fight tens of thousands of lawsuits by people claiming harm from Vioxx.

The new findings should be interpreted cautiously because of the small number of patients who suffered heart attacks, strokes and related problems after participating in the three-year study, said Doug Watson, a cardiovascular epidemiologist and senior director at Merck Research Labs.

He said the study had some other limitations and noted the authors stated that “small numbers prohibit detailed conclusions about when the increased risk begins and ends.”

“But our data are compatible with an early increase in risk that seems to persist for about 1 year after 3 years of treatment,” the authors added.

Known by the acronym APPROVe, the study was intended to prove that Vioxx, heavily promoted as relieving pain with lower gastrointestinal risks than older anti-inflammatory drugs, could prevent recurrence of colon cancer. Merck stopped the study two months early and pulled the drug from the market on Sept. 30, 2004, when data showed roughly double the risk of cardiovascular complications and death in the group getting Vioxx, over those getting placebo.

Merck funded the new analysis, provided the data and commented on an early draft of the report but said it had no other involvement. The analysis was conducted by six scientists who worked on APPROVe, plus two statistics experts at the University of Wisconsin who were not involved then, the company said.

The eight researchers reported in The Lancet that in the year after the 2,587-patient study was halted, 34 people who had taken Vioxx and 18 who had taken placebo suffered a heart attack, for a 94 percent higher risk with Vioxx; strokes occurred in 19 Vioxx users and nine people on placebo, for a risk slightly more than double. Altogether, 76 Vioxx users and 46 placebo takers had a heart attack, stroke, blood clot or died during that follow-up year.

The increase in those complications was roughly the same as what was found during the three-year trial and the first two weeks after the study ended — the period included when Merck first reported results of APPROVe in the New England Journal of Medicine in February 2005.

Merck critics have said it was inappropriate to end patient follow-up 14 days after the study.

“This study is raising an important red flag about that” cutoff, showing the risk persisted for at least a year, although too few patients were followed longer than that to see if the risk subsided, said Dr. Harlan Krumholz, a Yale University cardiologist who has assisted Vioxx plaintiffs suing Merck.

“It adds another important chapter to the Vioxx story, but also is an important warning to us about how we assess the safety of medication” long-term, including after use stops, Krumholz said.

After Merck published its first analysis of APPROVe, numerous experts criticized it. Editors of the New England Journal in 2006 published a correction stating the risk of heart problems was elevated throughout the time people took Vioxx.

Merck posted all the data from APPROVe — the data used in the new study — on its Web site that same month.

In an editorial, doctors from the University of Oxford in England and Catholic University of Rome wrote that differences in the approach of the new analysis make it clear there’s no “latent period” before Vioxx increases heart risks, and shows the danger appears to have been worse in people who already had risk factors — something they said is shown in a combined analysis of six studies of Celebrex.

Made by Pfizer Inc., Celebrex is the only drug from the same class as Vioxx still on the market in the United States.

The editorial writers also note that older nonsteroidal anti-inflammatory drugs — such as naproxen and ibuprofen — also can bring cardiovascular risk, plus risks of stomach bleeding and other complications.

Copyright 2008 The Associated Press.

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