HOSPITAL TB BLUNDER

Five people, including a child of 11, were halfway through a six-month course of antibiotics for the killer disease – but doctors yesterday told them they had made a mistake. The sixth had died of unrelated asbestos poisoning.They believe the same contaminated laboratory bottle spread traces of tuberculosis through each of the samples after routine tests in July.They were among nine cases of TB confirmed that month, compared with the usual two or three, and began their treatment in September.The cross-contamination was only uncovered last week after doctors realised none of the patients had symptoms of carrying TB and ordered genetic tests.And the red-faced experts called a meeting at Sunderland Royal Hospital yesterday to break the news and apologise to the six families, who have not been named because of patient confidentiality.They said they had acted in good faith and in the interests of patient health – and revealed that the system for testing samples at the Royal had now been overhauled to include disposable, single-use containers.Consultant physician in respiratory medicine, Niall Keaney, said none of the patients in the group, all in their 50s and 60s apart from the child, had been considered as being at risk.None had suffered side-effects from the antibiotics used to treat the disease, which can include dizziness, nausea, fever and jaundice.Dr Keaney said: "It has probably been traumatic for some of the individuals – more the relations than the patients themselves. Most of them are very pleased."They were just so thrilled. Maybe their later response would be anger, but not at the moment."Dr Keaney said about six people become seriously ill from TB every year in the city, with one death in recent years.The mistake came to light after he received a request from Health Protection Agency doctors in Newcastle for details on the dead woman's TB.He said he had never seen a patient with both TB and the asbestos-disease mesothelioma together in such a way and launched an investigation.And after DNA testing on all the TB cases in the region in the past two years, the six came back with identical genetic patterns – and the gaffe was discovered.Dr Keaney added: "I did feel embarrassed, but I knew I was giving good news."Looking back with hindsight, I shouldn't have believed the result, but I couldn't afford not to believe it."Carol Harries, director of corporate affairs at City Hospitals Sunderland, said: "Clearly, we apologise to all those concerned."The important thing for us is that we use such incidents as a learning exercise and it doesn't happen again."

Lawmakers urged to pass FAIR Act

There is broad agreement among thoughtful people in this country that the asbestos litigation system is broken. More than $80 billion has already been spent on asbestos litigation and nearly half of that has gone to lawyers rather than the true victims of asbestos -- individuals suffering from deadly mesothelioma and other forms of lung cancer linked directly to exposure to asbestos. These costs are rising and won't stop until the system is fixed.
Many businesses with only a remote connection to asbestos have found themselves named as defendants in asbestos lawsuits across the country. And why are these businesses with little or no connection to asbestos being sued? Because most of the companies that produced asbestos have long ago disappeared into bankruptcy.
To date, almost 100 companies have already been driven into bankruptcy by asbestos lawsuits and tens of thousands of U.S. jobs have disappeared as a result of asbestos-related bankruptcies. Scores of additional companies -- many of which never made, sold or distributed products containing asbestos -- today teeter on the brink bankruptcy. Clearly, a broad, national solution to this legal and business crisis is needed.
The Fairness in Asbestos Injury Resolution Act (FAIR Act), which has already been approved by a bipartisan margin in the Senate Judiciary Committee, will put an end to the inequity in the current system and finally provide relief to sick victims. The bill would take asbestos claims out of the courts and compensate the truly sick on a no-fault basis from a trust fund financed by defendant companies and their insurers.
Some opponents of the bill would have you believe that this bill will harm small businesses, but small businesses needn't be worried that the trust fund will drain them of their necessary capital funds.
First, small businesses, as defined under the Small Business Administration Act, and businesses with less than $1 million in previous asbestos expenditures, will be exempt from any funding obligations under the FAIR Act. And the fund administrator would be required to grant hardship and inequity relief to companies that can demonstrate that its FAIR Act funding obligations would lead to insolvency.
Without this important bill for sick victims and the many economic victims of out-of-control asbestos litigation, greedy trial lawyers will continue to milk the system for profits and victims of asbestos exposure will continue to get only a fraction of the compensation they deserve. What's more, many American workers and retirees will continue to suffer the economic consequences of a system that creates serious financial uncertainty for employers.
We call on Senators Debbie Stabenow and Carl Levin to do what's right for Michigan's workers and for the many thousands of sick asbestos victims trapped in today's broken legal system. I urge both Michigan senators to support the FAIR Act when it comes up for full Senate consideration this fall.
John "Mac" MacIlroy is the president and CEO of Michigan Manufacturers Association, 620 South Capitol Avenue, Lansing, MI 48901-4247.

Clark case could hurt sex victims

THE outcome of hundreds of compensation claims for children abused in care could depend on a ruling involving rape claims against former ATSIC leader Geoff Clark.
Recent Court of Appeal rulings on extension of time in civil cases have been cited by a children's home which, at the 11th hour, pulled out of a mediation meeting with a former resident.
Peter (not his real name) alleges he was abused over a five-year period in the 1960s at the Burwood Boys Home (now the Child and Family Care Network).
He said the network pulled out of a July 12 settlement conference, which forced his lawyers to take action in court.
Law firm Ryan Carlisle Thomas filed affidavits in the County Court last Thursday in support of an extension-of-time application.
Whether the extension is granted could depend on a pending High Court appeal in the case of Carol Stingel, who alleges she was raped by Mr Clark in 1971.
This year, the Court of Appeal ruled that her case could not proceed because of the time lapse.
But she argues that only in 1999 did she become aware of the psychological damage caused by the alleged event, and that her case should be considered outside the six-year time limit.
Other conditions considered outside the time limit include asbestosis and mesothelioma, because symptoms often do not emerge for many years.
Peter's lawyer, Angela Srdinis, said that if the High Court ruled against Ms Stingel it would make it harder for victims of sexual abuse.
"They will have to go begging, cap in hand, for an extension of time," Ms Srdinis said.
"That way makes it a much more drawn out, difficult and traumatic process for them. There is no doubt that Clark has made it easier for some organisations to defend themselves."
Peter, who says he was sexually abused by two senior male staff, said he was devastated when he learned the mediation had been cancelled.
"I feel betrayed," he said. "It was another kick in the guts."
He is angry the network used the Geoff Clark ruling as an "excuse". "They are hiding behind the law. This organisation, in refusing to mediate, is way out of step with others," Peter said.
"The Catholics, Anglicans, Uniting Church, Salvos — they all have processes, they will meet with you. For a philanthropic organisation, this is amazing hypocrisy."
The home became the Child and Family Care Network in the 1980s. Deputy chief executive Pauline Ogden said the network no longer ran residential care.
"We now support families at the early stages of childhood. Our aim is to strengthen families so that care would be a last option," Ms Ogden said.
She said she could not comment on Peter's case because it was before the courts.
The network has six weeks from last Thursday to file its own affidavits. Peter's lawyers will then respond before a hearing date is set.

Rare cancer drug released

CHINA could face a large increase in the incidence of a rare but deadly form of cancer linked to asbestos by 2030 if it doesn't take proper measures to rid buildings of the material, doctors said over the weekend. US-based Eli Lilly announced over the weekend that it has introduced Alimta, the world's first medication to treat the asbestos-related malign pleural mesothelioma, or MPM, a cancer of the chest and abdominal linings. Currently, about 10,000 to 15,000 people are diagnosed with MPM annually around the world. "Though many western countries have banned several asbestos products, the international medical community estimated a MPM peak in 2010 in the United States and in 2020 in Europe," said Dr Liao Meilin from Shanghai Chest Hospital. The incidence in China is still as low as three to five in every 1 million, but the incidence rate is on the rise and should peak around 2030, since asbestos is still used in many industries and workers don't adopt proper protection, experts said. Asbestos is a mineral fiber used in a variety of building construction materials for insulation and as a fire-retardant. It can be found in older homes, pipe and furnace insulation materials, asbestos shingles and other coating materials. Elevated concentrations of airborne asbestos occur after asbestos-containing materials are disturbed by cutting, sanding or other remodeling activities. Most people with asbestos-related diseases were exposed to elevated concentrations on the job; some developed disease from exposure to clothing and equipment brought home from job sites. "There is no immediate symptoms, but patients can develop chest and abdominal cancers and lung diseases in 20 to 40 years," Liao said.

Judge says smokers responsible for own health

A judge has cut compensation to the widow of a smoker who died of asbestosis, saying that tobacco smokers must take responsibility for their own health, and warned that his ruling could affect future payouts.
Mr Justice Stanley Burnton cut by 20 percent a payout to the widow of a dockyard worker who died of asbestosis because of the worker's own "contributory negligence" in failing to give up smoking.
The judge said on Friday it was "surprising" that no English court had ever before been asked to decide whether smoking is "negligent". He said his ruling was likely to have an impact on many other compensation cases.
"Medical experts say that people who were exposed to asbestos are more likely to develop mesothelioma if they are smokers. Therefore there are likely to be a number of other cases that are affected by this," said Fraser Whitehead, a partner at law firm Russell Jones & Walker.
But he added: "It's quite a harsh judgement. I suspect it will be appealed, and I suspect it will be successfully appealed."
Insurance industry figures said the judgement was unlikely to lead to a wave of cases in which insurers seek to use this ruling to reduce compensation awards for asbestos-related illness claimants.
"Will it set a precedent that will see people fight these cases more regularly? Probably not," said David Ross, a spokesman for Norwich Union, Britain's biggest general insurer. "Is it going to affect insurance premiums? Probably not."
"It's an unusual set of circumstances, and the vast majority of asbestos cases are not likely to be influenced by a judgement like this," Ross said.

Drug investors turn more to lawyers for help

Investors in pharmaceutical companies are becoming increasingly reliant on lawyers to help decipher complex patent litigation and safety-related lawsuits, experts say.
The withdrawal of Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) painkiller Vioxx and subsequent deluge of lawsuits from people claiming to have been hurt by it, together with patent challenges to several top-selling drugs, have led investors to embrace legal experts as never before.
"Legal issues are now involved in a much larger percentage of the valuation swings in the pharmaceutical industry," said David Webster, a consultant at Webster Consulting Group. "Good lawyers are seeing a dramatic increase in business.
Pfizer Inc.'s (PFE.N: Quote, Profile, Research) shares jumped 10 percent on Monday after it won a U.S. court victory blocking a threat from a generic drugmaker to its biggest-selling drug, the cholesterol-fighter Lipitor.
The ruling came as a surprise to many investors and a relief even to those who had bet on the victory, boosting drug stocks in general amid optimism that other patent challenges too would be similarly defeated.
While drug companies have always faced legal battles, and investors have always turned to lawyers for advice, the stakes within the pharmaceutical industry are rising as they no longer have such a rich supply of new drugs waiting to fill the place of those losing patent protection.
A record number of drugs, representing combined U.S. sales of about $61 billion -- or 27 percent of the entire U.S. retail pharmaceutical market -- are set to lose patent protection or market exclusivity by 2009, according to a recent report by SG Cowen & Co.
At the same time many industry experts say U.S. regulators have become more cautious about approving new drugs following criticism that they responded inadequately in the Vioxx affair, raising the stakes for drugmakers even further.
"Investment processes that involve legal experts are becoming more frequent and savvy investors are doing very diligent work with legal consultants," said Shaojing Tong, an analyst at Mehta Partners.
With Lipitor out of the way, investors are now focusing on the outcome of a patent challenge to Bristol-Myers Squibb Co.'s (BMY.N: Quote, Profile, Research) biggest-selling drug, blood-thinner Plavix.
"Even though the patents and patent law issues are different, the Lipitor victory may hearten investors concerned about the upcoming Plavix litigation," said Chris Shibutani, an analyst at J.P. Morgan in a research report.
Still, no amount of legal advice can eliminate the investment risk entirely and lawyers can rarely predict an outcome with certainty. Some can't predict it at all.
"Our capacity to do things like predict outcomes, let alone predict damages in situations where there are thousands of lawsuits, is very limited," said Jeffrey Rudman, a lawyer at Hale and Dorr. "A lot of times its horseback opinion and has to be heavily discounted."

Anti-obesity drug may go OTC

A pill that blocks some fat from being absorbed by the body could become the first prescription obesity drug to go over-the-counter.
In late January, a Food and Drug Administration advisory committee will review Glaxo-SmithKline's application to sell a nonprescription 60-milligram dose of orlistat, which is sold as Xenical.
Xenical has been available by prescription in a 120-milligram dose since 1999.
Because Xenical would be the first prescription obesity drug to go OTC, Glaxo probably won't be able to persuade the FDA advisers that the switch is warranted, says industry consultant Steve Francesco.
"Historically, a switch like this has to go through FDA twice," says Francesco, publisher of a newsletter about OTC switches.
Heightened concern about drug safety in this post-Vioxx era means the slightest hint of a problem would be enough to prevent Xenical from going OTC, Francesco says. "Even though it looks very clean, I think something will come up."
This past January, an FDA advisory panel voted 20-3 against recommending approval of OTC Mevacor, a cholesterol-lowering drug. Maker Merck failed to show that consumers properly could decide on their own whether to take the drug, panelists said.
Xenical is available without a prescription in Australia and New Zealand, but it's not OTC. In those countries, Xenical falls into a third category of drugs available only from a pharmacist. The USA has no such "behind-the-counter" drug category.
Xenical keeps about 30 percent of dietary fat from being absorbed by the intestine. It's designed for obese people who have 30 or more pounds to lose or those who have less to lose but also have other health risks, such as diabetes or high cholesterol.
Studies show that patients who are prescribed Xenical and cut about 600 calories a day can expect to lose 5 percent to 10 percent of their weight in six months.
Glaxo's proposal "recommends" that those younger than 18 "seek the advice of their physician."
The company has suggested working with retailers to verify the age of people who want to purchase OTC Xenical, an approach Glaxo already has taken with Nicorette and NicoDerm CQ, used to help smokers quit.
Xenical "has shown to be safe in children, but there are a lot of things we think adults need to supervise, and this is one of them," says obesity drug researcher Louis Aronne, director of the Comprehensive Weight Control Center at New York-Presbyterian Hospital.
"This is far safer" than dietary supplements touted for weight loss, "which either don't work or are risky," says Aronne, who has conducted research on Xenical and prescribes it to patients.

Opinion | Vioxx Case Indicates Need for 'Slowed' FDA Approvals of New Medications, Op-Ed Says

The COX-2 inhibitor Vioxx, which Merck withdrew from the market in 2004 over safety concerns, "might be doing some good in limited use today, if only the FDA had slowed the approval process enough for the data about danger to catch up with the marketing hype," a Boston Globe editorial states. According to the editorial, "the industry and Congress want these drugs made available quickly, and the drug manufacturers pay the cost of the FDA approval process to hurry them along. This represents a change in attitude from a generation ago, when the FDA was proud of its deliberate pace." The editorial adds that a "quicker policy is justified in treatments for such life-threatening diseases as AIDS" but not for pain medications, which "do not present the same case for urgency." The editorial concludes, "No one wants to return to the days when FDA sluggishness delayed the approval of life-sustaining medicine, but there has to be a middle way between long delays and an approval process that makes millions of pain sufferers into unknowing guinea pigs. Tighter regulations may lessen company profits, but they will ensure that the medicines Americans take are once again considered the safest on Earth" (Boston Globe, 12/19).

Stocks Rise Despite Smaller Intel Forecast

Stocks rose in early trading Friday as Wall Street reconciled itself with Intel Corp.‘s tightened forecast and a recent runup in energy prices.
Oil and gas prices were higher in premarket activity but fell slightly despite a snowstorm in the Northeast that was expected to drive a spike in heating fuel demand. On the New York Mercantile Exchange, natural gas lost 13.4 cents to $14.86 per 1,000 cubic feet, and a barrel of light crude dropped 6 cents to $60.60.
Broader stock indicators were also higher. The Standard & Poor‘s 500 index was up 2.07, or 0.16 percent, at 1,257.91, and the Nasdaq composite index added 4.20, or 0.19 percent, to 2,250.66.
Intel trimmed $200 million from both the high and low ends of its fourth-quarter sales estimate, narrowing its forecast to a range of $10.4 billion to $10.6 billion. Intel‘s revision, which fell slightly below Wall Street expectations, follows a sharpened outlook at rival Texas Instruments and improved guidance from Xilinx Inc. Intel fell 23 cents to $25.47, while TI gained 25 cents to $32.88 and Xilinx rose 51 cents to $26.53.
Merck & Co. slipped 71 cents to $28.97 after the New England Journal of Medicine New England Journal of Medicine on Thursday said researchers failed to disclose that three patients suffered heart attacks in a 2000 Merck-funded study of its Vioxx Vioxx painkiller. Meanwhile, jurors in the first federal Vioxx trial were to continue deliberating whether Merck failed to warn about the drug‘s risks.
The Russell 2000 index of smaller companies rose 0.99, or 0.14 percent, to 686.21.

Lessons from Vioxx

MERCK PHARMACEUTICAL company took the pain reliever Vioxx off the market more than a year ago, after a clinical study found that it caused heart attacks. And now instead of helping people with chronic pain, it is the subject of thousands of lawsuits contending that it helped to kill them. The drug might be doing some good in limited use today, if only the Food and Drug Administration had slowed the approval process enough for the data about danger to catch up with the marketing hype, which included an article in the New England Journal of Medicine.
Six and a half years ago, Merck was riding high as the FDA allowed Vioxx to go on sale. It would compete with Pfizer's Celebrex as a prescription medicine to relieve the pain of people with arthritis and other chronic pain conditions. Its great advantage over aspirin and other traditional pain relievers was that it wouldn't cause stomach bleeding in people who used it regularly.
Several of Merck's blockbuster drugs were losing their patent protection, but, aided by a marketing campaign spearheaded by the figure skater Dorothy Hamill, who glided pain-free across the ice in television commercials, Merck was confident of making billions of dollars from the new medicine. ''Vioxx has indeed been the biggest, fastest, and best launch ever in Merck history," said David W. Anstice, president of Merck Human Health, North America, late in 1999.
Earlier in 1999 researchers at the University of Pennsylvania had found that these kinds of pain relievers, called COX-2 inhibitors, might erode the body's protection against blood clots, which can cause heart attacks and strokes. The risk seemed small in the limited studies, but the finding argued for a cautious rollout and constant monitoring of patients to determine risk, not the Big Bang of marketing efforts.
But the industry and Congress want these drugs made available quickly, and the drug manufacturers pay the cost of the FDA approval process to hurry them along. This represents a change in attitude from a generation ago, when the FDA was proud of its deliberate pace. A quicker policy is justified in treatments for such life-threatening diseases as AIDS, but Vioxx and Celebrex, for all their pain-relieving potential, do not present the same case for urgency.
RELATED STORY: Scientists plan huge painkiller risk study
In 2000, physicians associated with Merck submitted an article to the New England Journal of Medicine that found that Vioxx did indeed minimize stomach problems compared with a different kind of pain medicine. Buried within the piece was the hint that there was other data somewhere about heart troubles, but any differences there were ascribed to beneficial side effects of the control drug, not the harmful impact of Vioxx.
In hindsight, the New England Journal's staff should have been especially vigilant about the Vioxx article. Journal editors did vet it with outside experts, as is customary, but greater scrutiny is needed when the article deals with a drug with great profit-making capabilities. In September, the Journal and other prestigious medical publications decided to insist that all the data from clinical trials mentioned in articles be available for verification. That's an important improvement if journal editors make sure companies clearly disclose any problems with the drugs.
The real problem, however, is the FDA and the entrepreneurial atmosphere that surrounds the introduction of many new drugs. Prescription medicine, aided by massive marketing and the absence of price controls in the United States, is considered a major growth industry by Wall Street. With billions of dollars at stake, corners may be cut.
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The Journal said its investigation benefited from information obtained by subpoena in one of the 6,400 lawsuits filed by aggrieved Vioxx users or their families. It shouldn't take court proceedings to reveal damaging information about prescription drugs, but that's going to happen again unless the FDA toughens its approval process.
Senator Charles Grassley, the Iowa Republican who heads the Finance Committee, and Senator Christopher Dodd have bills to do just that, but they have languished since February in the Senate Health, Education, and Labor Committee. This is headed by Mike Enzi of Wyoming; the ranking Democrat is Edward Kennedy.
Grassley's proposal would mandate that information from clinical trials be put in publicly available data bases. This would compel the drug companies to provide the data that the journal editors are seeking.
Grassley also wants to establish a separate drug safety office within the FDA. This ought to provide an institutional check on FDA inclination to approve drugs too quickly. Both of Grassley's proposals seem to be sensible improvements in the status quo, but perhaps Enzi and Kennedy can come up with some that are better. A plan to improve the approval process needs to get out of committee and win congressional approval next year.
RELATED STORY: Scientists plan huge painkiller risk study
Other proposals range from limiting television advertising to reverting back to the system in which the government, not the drug companies, defrayed the cost of approving a drug. It's hard to envision Congress giving up a source of revenue when the federal budget is many billions of dollars in the red. But Congress ought to ban consumer advertising, which the FDA did not allow until 1997. Prescription drugs should not be the object of a consumer marketing frenzy.
Vioxx is held in such low regard that a jury deadlocked on a verdict last week even though the patient, a man with a heart condition who later died, had only taken the drug for a month. Vioxx probably didn't cause all the heart attacks for which it will be blamed in court, but because Merck portrayed it as a safe drug for so long, many jurors are loath to give the company the benefit of the doubt.
No one wants to return to the days when FDA sluggishness delayed the approval of life-sustaining medicine, but there has to be a middle way between long delays and an approval process that makes millions of pain sufferers into unknowing guinea pigs. Tighter regulations may lessen company profits, but they will ensure that the medicines Americans take are once again considered the safest on Earth.

Drug Studies' Gaps a Problem

Federal regulators at the Food and Drug Administration dictate which drugs can be sold in the U.S., but studies published in leading medical journals help decide which will be the most widely prescribed. Like reviews of Broadway plays, those studies are often excerpted or reprinted. They become part of drug companies' sales pitches aimed at doctors and, more recently, at patients.
A growing body of evidence has shown that studies paid for by drug companies are more likely to produce positive results for that company's products. But it is relatively rare that companies are accused of outright manipulation of data.
[Earlier this month], however, the New England Journal of Medicine accused researchers sponsored by drug-maker Merck of withholding information about the deaths of three patients in order to soft-pedal the risk of fatal heart attacks for patients taking Vioxx, the company's widely prescribed arthritis medicine.
It's a serious charge, because on the strength of such articles and ads aimed at patients, Vioxx became a blockbuster drug. It was pulled from the market late last year after long-term studies showed it did indeed increase the risk of heart attack and stroke. Merck is now facing thousands of civil suits. The first to be tried in federal court ended in a mistrial [last] week.
The company insists that it did nothing wrong. It said the deaths were reported to the Food and Drug Administration, which subsequently allowed Vioxx to be marketed.
The New England Journal claims researchers knew about the deaths more than four months before the article was published. The information originally was included in working drafts but was deleted two days before the article was sent to the New England Journal. Had the deaths been included in the original article, it would have shown a fatal heart attack rate five times greater among patients taking Vioxx than those taking a comparison drug.
By publishing lower rates, the authors were able to argue that the association between Vioxx use and heart problems was less clear.
The public health issue raised by these revelations goes well beyond Merck and Vioxx. Most pharmaceutical research is paid for by drug companies. Those companies have an enormous financial stake in the outcome, both in profits and potential liability. That's especially true now that drug companies can advertise directly to patients.
Medical journals must be able to rely on researchers to ensure that the data they report is complete and accurate. Doctors must be able to rely on medical journals to ensure they get the whole story about a drug's advantages and side effects. Last week's accusations provide more new evidence - if any more were needed - of the necessity for conservatism and healthy skepticism by doctors and patients eager for the next big thing.
Doctors must be able to rely on medical journals to ensure they get the whole story about a drug's advantages and side effects.

Victorian man tells of Vioxx trauma

Grandfather of seven Graeme Peterson says he was fit and healthy when Vioxx tore his life apart two years ago.
The 55-year-old Victorian man suffered a heart attack in December 2003 after taking Vioxx for almost four years to treat arthritis in his hips and neck.
Since then, Mr Peterson has had about four coronary episodes and says his life has changed dramatically for the worse.
"I've got seven grandkids that I used to love to play quite actively with - (now) I tone it down," he said.
"I used to go on long walks in the bush; I used to go out in the bush for a week at a time, I don't do that now.
"If I go away I'm very conscious of the fact I've got to take a lot of medication with me, I've got to make sure that where I go there's medical help available if necessary - that's changed my life dramatically."
Mr Peterson is leading a 400-strong class action against the manufacturers of Vioxx over his ailing health and the Australian distributor who he says "let it happen".
"If I'd known of the risks of taking Vioxx I would have given up Vioxx," he said.
"I took it for an arthritic condition, I would have lived with that arthritic condition given the choice - I wasn't given the choice."
Mr Peterson was formerly the global safety manager at BHP and a sea captain. He now works part time, suffering a significant loss of income.
He said he had a medical two weeks before his heart attack as part of an underwater escape training exercise and was given a clean bill of health.
Today, he takes medication daily and carries a nitrolingual spray to guard against a heart attack at the first sign of trouble.
Mr Peterson says the situation has taken an enormous toll on his family, and supporters and is determined to make Merck pay.
"Knowing somebody knew about this, knew what I and many others were facing, and let it happen, that's even more frustrating," he said.
Lawyers Slater and Gordon today filed a writ in the Supreme Court of Victoria seeking damages for at least 400 victims, including relatives of up to 50 people who died while using the drug.
They are seeking compensation against US drug manufacturer Merck & Co Inc Ltd and its Australian subsidiary Merck Sharp & Dohme Australia, who assembled, marketed and distributed the tablets.
The class action comes after Vioxx was withdrawn from sale under a global recall on September 30, 2004.
About 250,000 Australians used the drug before it was recalled.

Drug firms plan safety studies to calm concerns

Pfizer Inc. was even more prepared than usual when it met with a federal advisory committee that would decide whether to recommend an inhaled insulin for approval.
As is typical, Pfizer offered the safety and effectiveness data collected from clinical trials, but it also showed plans for several studies to continue to monitor the drug's safety should it be approved. Two have already started but weren't far enough along to be included in the company's application to the FDA.
Pfizer isn't alone. Bristol-Myers Squibb Co. came armed with similar plans to other meetings earlier this year.
Such strategies aren't common, but experts said the trend is likely to become entrenched in an environment of heightened concern about drugs' safety.
"I think this will be the norm," said John LaMattina, president of Pfizer Global Research and Development. "When you have something new there is the theoretical potential for harm."
Merck & Co.'s withdrawal of its pain reliever Vioxx last year continues to cast a pall over the industry. It showcased that no drug is completely safe and that side effects may not manifest themselves in clinical trials with several thousand people, but may when taken by millions.
Now, companies are attempting to design studies that will find problems sooner and show the U.S. Food and Drug Administration, patients and doctors that they are seriously concerned about identifying risks.
"These days you have to walk in (to the FDA) with a Phase IV (post-marketing study) because if you don't agree to do it, your product approval may get delayed," said Dan Troy, a lawyer who was chief counsel at the FDA and is now in private practice.
Such tactics don't guarantee success. The FDA committee recommended approving Exubera -- the inhaled insulin Pfizer is developing with Sanofi-Aventis SA and Nektar Therapeutics -- but the agency has delayed the decision. Meanwhile, the FDA won't approve Bristol-Myers' diabetes medicine without additional data.
Bristol-Myers said it could take five years to accumulate the data and hasn't decide whether to make the effort.
The FDA can only require companies to conduct post-marketing studies in limited circumstances, such as when a drug receives an expedited approval because it meets an unmet medical need such as certain kinds of cancer drugs. And there has been concern that even those aren't completely in a timely fashion.
Otherwise, companies can commit to the studies but face no penalties should they fail to complete them.
But industry executives say companies are thinking about post-marketing safety studies sooner in the development process and conducting them for already approved drugs. Traditionally, post-marketing studies were conducted to prove a medication effective in treating a new condition or, more recently to show superiority over a competing product.

Canada bans Pfizer arthritis drug Bextra

Canada banned Pfizer Inc.'s arthritis drug Bextra on Friday because of risks of heart attacks and strokes.
Bextra sales in Canada were suspended by Pfizer in April at the government's request.
"Following a review of safety information, Health Canada is informing the public that Bextra, an anti-inflammatory drug used to treat arthritis and pain, will not return to the market," the government said in a statement.
"The decision to stop the sale of Bextra is based on information submitted by the manufacturer, Pfizer Canada Inc., and consultations with external experts and the public. Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use."
Pfizer's suspension of sales in April was simultaneous with similar actions in the United States and Europe, after regulators voiced concerns over cardiovascular risks.
Bextra racked up global sales of $1.3 billion in 2004, and in May this year Pfizer expressed confidence about the drug's eventual return to the market in the United States because it was needed by patients.
Health Canada initiated a review of Bextra and related drugs following Merck & Co. Inc.'s withdrawal of a similar drug, Vioxx, in September 2004.
Bextra and Vioxx are both COX-2 selective inhibitor non-steroidal drugs, and the review looked at other non-steroidal anti-inflammatory drugs, or NSAIDs too. Examples of traditional NSAIDs are aspirin, ibuprofen and naproxen.
The Health Canada review concluded that COX-2s and all other NSAIDs are associated with an increased risk of cardiovascular problems when high doses are used for long periods.
"However, the exact nature of that increased risk may differ from one product to another," it said.
As for Vioxx, it remains suspended, but the government said in July that it saw no reason not to allow it back on the market if Merck requested it.

Serwer: Two losers and a winner

NEW YORK (CNNMoney.com) - Altria, Merck and GM. Three companies in the news. Three companies that have been in, or are in, the deep stew. Do any of 'em make sense to buy right now? Hey you're supposed to pick stocks when they're cheap right? Well here's my take.
MERCK: I say don't buy it yet. There are several big problems here. One: Vioxx litigation, and Two: a lack of high quality new drugs in the pipeline. The latter happens from time to time, the former is an unquantifiable issue, and that's the problem. You just don't know how bad things are yet. Just the other day another shoe dropped: the New England Journal of Medicine reported more problems with Vioxx testing. Also, the federal Vioxx case in Texas ended in a mistrial and there are thousand more to go. Only positive: The stock (Research) hasn't been this cheap since dinosaurs roamed the earth. Trailing P/E of 14. Still I say dead money for a while, though at some point this will be a buy.
GM: Nope here too. Problems at GM are just too huge. At $22, GM's stock is exactly where it was in 1962! That's 43 years! As in when JFK was president! Yes I know the company has paid dividends, but this a loser of mammoth proportions. And there is no reason to believe that things will be any different going forward. Ooops, actually I'm wrong. It could be worse. And don't think GM (Research) can't go bankrupt. It can. Just ask Standard & Poor's. The company keeps losing billions and there won't be a choice! The only way out of this trap is if GM breaks the United Auto Workers. And I don't think that will happen. The UAW will go down with GM. Avoid I say.
Altria: This puppy is looking good to me. Yes I know the stock is up 32 percent this year, and it has more than doubled since 2003. The Illinois Supreme Court throwing out the $10 billion verdict in the Price case is a huge boost. ('Lite' cigarette cases appear pretty bogus to me.) But I would argue that Altria is still relatively cheap, P/E below 16 on a trailing basis, (can you BELIEVE Merck is cheaper than Altria!) Plus, Wall Street moves slowly. There is still a huge bias against the Big Mo (Research) (as it's called on the Street.) And the Kraft spinoff will only add value---the company will also likely split off its still-growing international tobacco business. Even at these "lofty" levels, Altria still yields 4.3%. So as Commander Cody used to say, "smoke, smoke, smoke that cigarette!"

Merck as comeback kid? Wall Street reacts

A greater emphasis on technology to cut drug development times and a focus on under-treated diseases are key components of Merck's comeback plan unveiled earlier this week, but some Wall Street analysts seem guarded about the company's aggressive optimism for the future.
The embattled company's comeback strategy features key pipeline products like cervical-cancer vaccine Gardasil, shingles vaccine Zostavax and Type 2 diabetes drug Januvia -- all of which the firm is banking on to reclaim its glory days at the pinnacle of Big Pharma.
Merck's new CEO Dick Clark said at an investor meeting this week that the plan was aimed at reducing Merck's spending per brand by 15 to 20 percent; spurring 4 percent to 6 percent adjusted revenue growth; and catapulting its earnings growth back into the double digits over the next three to five years.
Merck also said it would use technology to trim nine months from in late-stage drug development times by 2007.
While market analysts were generally skeptical whether the plan was the right antidote to Merck's Vioxx woes, some seemed to feel that Merck -- faced with nearly 7,000 lawsuits related to the fallen blockbuster drug -- has nowhere to go but up.
"While we agree that management's growth forecasts seem ambitious, expectations for Merck are so low that, even if its targets fall short, the stock could still handsomely outperform," said Morgan Stanley market analysts Jami Rubin, Nancy Yu and Carlos Garcia-Tunon in a note issued this week. Commenting on Merck's strategy, the analysts said, "To call the plan aggressive is an understatement, given that it implies 2010 (earnings per share) of $4.00 to $4.20, while consensus expectations prior to (Merck's investor meeting) suggest a 2010 forecast range of $2.60 to $2.90."
While the analysts said parts of Merck's plan could merit a raised earnings estimate, they stressed that they "will not give Merck the full benefit of the doubt from day one, particularly on the revenue front, given the development, regulatory, and commercial risks."
However, Morgan Stanley seemed encouraged by Merck's news that it has three new products advancing to Phase 3 clinical trials -- including drugs to treat diabetes, heart disease and AIDS -- and by Merck's stated plans to trim $1 billion from its SGA budget.
"We believe it will take some time for the consensus to embrace Merck's view of the next five years, but (we) view many elements of management's target as credible," the analysts said.
As Merck -- which not so long ago was at home on the Fortune 500's "Most Admired Companies" list -- struggles to reclaim its place at the top, what about its Albatross pain reliever?
Some experts think Vioxx could stage a comeback of its own.
Gregory K. Frykman, senior policy analyst at the Stanford-Washington Research Group and former medical reviewer at the Food and Drug Administration, wouldn't rule out the possibility. "Vioxx is, in my view, being substantially over-criticized. Yes, it's got its problems, but it's been vilified, and it's not worse than the other stuff out there," he told United Press International.
Frykman predicted that the Pfizer-funded study of the company's arthritis drug Celebrex -- the only Cox 2 inhibitor drug still on the market -- Vioxx and other pain relievers, which he estimated would take about two years to complete, would resolve the Cox 2 puzzle "once and for all."
Frykman also forecast that Vioxx would likely emerge from the study looking not much worse than the pain reliever ibuprofen in terms of risks.
"I think there is no unreachable regulatory barrier in place for that drug coming back on the market in some form," Frykman said, whether at a low dose or with labeling for very restrictive use.
So why hasn't Merck acted? "They probably know that Pfizer was going to do this trial and it would be embarrassing to put a drug back on the market only to find out it's worse and then yank it off again," Frykman said. Plus, Merck "wants to see how the court cases go," he added.
Although he stressed that policy, not corporate strategy, is his area of expertise, Frykman said that if Vioxx's image is rehabilitated, Merck still might opt to wash its hands of the drug altogether. A small company might approach Merck with a deal to buy the Vioxx division, sans liability, and pay Merck royalties on sales.
Even 1 percent of the drug's former market share -- which was roughly $25 million a year -- would be a "pretty decent" return, he said.
At Merck's investor meeting, Clark told investors, "Merck will remain a research-driven pharmaceutical company, but we need to change our approach to virtually every aspect of our business, and we must act with a sense of urgency," said the company's new CEO Dick Clark as Merck held an investor meeting on its new strategy Thursday.

Federal Vioxx retrial set for February in New Orleans

Round Two of the nation's first federal trial challenging safety of Merck & Co.'s drug Vioxx will be Feb. 6 in New Orleans, a judge told attorneys Friday. U.S. District Judge Eldon Fallon of New Orleans held a private telephone conference with attorneys on both sides Friday to set the date and place to retry the case that ended Monday with a hung jury.
The trial, which began Nov. 29 and went into the jury's hands after closing arguments Dec. 8, took place in Houston because of Hurricane Katrina's wrath on its original venue of New Orleans. Jere Beasley, one of the lead plaintiff's attorneys, and Kent Jarrell, spokesman for Merck's legal team, said Fallon set the date in the case's original venue. Fallon declared a mistrial 20 minutes into the jury's fourth day of deliberations Monday because the panel hadn't reached a unanimous verdict _ as required in federal litigation _ after 18 hours of deliberations. Two jurors told The Associated Press that one of the nine-member panel refused to absolve Merck of liability, leaving them split 8-1 in favor of the company. The result leaves Merck with a win and a loss in two state trials and an undecided in its first federal trial. The company withdrew Vioxx from the market in September 2004 when a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. About 20 million people took the once-popular painkiller, and the company faces billions in potential payouts stemming from about 7,000 pending state and federal lawsuits. The federal trial centered on the 2001 death of Richard "Dicky" Irvin, a Florida wholesale seafood company manager who took Vioxx for about a month. Merck blamed Irvin's clogged arteries for his death, and said Vioxx couldn't be responsible because he took the drug for such a short time. Irvin's widow, Evelyn Irvin Plunkett, countered that Vioxx caused a blood clot in one of Irvin's arteries, which led to his fatal heart attack. One of the jurors, Amanda Toungate, said she didn't believe the drug caused Irvin's death, though she thought Merck should have done a better job telling patients about Vioxx's risks. "He had too many other risk factors," she said. Before noon Saturday, jurors told Fallon they were deadlocked. The judge encouraged them to continue deliberating for a "reasonable time," and they complied. But by Monday, the judge had decided 18 hours was enough, and declared a mistrial, attorneys said afterward. "He told us in chambers that he had decided they had deliberated long enough," said Phil Beck, Merck's lead lawyer in the case. On Dec. 9, the jury's second day of deliberations, Plunkett's attorneys asked Fallon in a closed-door meeting for a mistrial based "in large measure" on revelations the day before from the New England Journal of Medicine, said Leigh O'Dell, one of those attorneys. The journal accused the company of withholding damaging information about a 2000 Vioxx study from the publication so the drug would appear safer than it was. The 2000 study, called VIGOR, is not the same study that prompted the drug's withdrawal. VIGOR showed Vioxx caused five times as many heart attacks as the older painkiller naproxen. The journal said the information Merck submitted to the publication said Vioxx caused four times as many heart attacks as naproxen. Merck said more information about heart attacks emerged after the journal article was submitted by the publication deadline, and the higher heart attack risk was disclosed to the Food and Drug Administration. Beasley declined to explain why his team asked for a mistrial based on the journal revelations before the jury said it was deadlocked or before the trial's outcome was known. Fallon never ruled on their unwritten mistrial request. Beck said the deadlock prompted the judge to declare a mistrial. "He declared a mistrial not on the grounds of the New England Journal of Medicine but on grounds that the jury had told him they were deadlocked," Beck said.