Merck to appeal Vioxx ruling
WHITEHOUSE STATION, New Jersey
Merck and Co. said it will continue to fight to prove its innocence after a Texas jury found it guilty in a wrongful-death case brought by the widow of a man who had died after using its blockbuster painkiller rofecoxib (Vioxx).
On August 19, a Texas jury awarded damages totaling more than US$253 million to Carol Ernst whose 59-year-old triathlete husband Robert had died in May 2001 from heart failure after using Vioxx to treat pain in his hands. The stunning total levied by the jury in the first of many Vioxx lawsuits included US$229 million in punitive damages for liability, negligence, and malice.
Merck said it would appeal the ruling, and expressed confidence the award would not stand. "The case presented to the jury by the plaintiff was fundamentally flawed. The jury was allowed to hear testimony that was not based on reliable science and that was irrelevant," Merck senior vice president and general counsel Kenneth Frazier said. "We have strong points to raise on appeal and are hopeful that a higher court will correct the verdict. Even if the verdict were to be upheld, punitive damages under Texas law would be limited to approximately US$2 million."
Merck has been deluged with lawsuits around the world since it yanked the US$2.5-billion-a-year seller Vioxx from the market last September after an internal study showed it increased the risk of strokes and heart attacks. The drug was taken by more than 20 million people worldwide before its withdrawal.
Ernst's lawyer, Mark Lanier, said Merck had conducted a "faceless and nameless" act in selling Vioxx for at least seven months after discovering potential health problems with the medicine. "You can't just use your money and resources to run. At some point the running has to stop," he said, vowing to pursue other cases against Merck brought by plaintiffs across the United States.
Merck, however, says it withdrew Vioxx as soon as it knew of any potential health risks and that in any case, the drug did not cause Robert Ernst's death.
"There is no reliable scientific evidence that shows Vioxx causes cardiac arrhythmia, which an autopsy showed was the cause of Mr. Ernst's death, along with coronary atherosclerosis," Merck lawyer Jonathan Skidmore said. "Merck acted responsibly--from researching Vioxx prior to approval in clinical trials involving almost 10,000 patients, to monitoring the medicine while it was on the market, to voluntarily withdrawing the medicine when it did."
Merck lawyers argued that Robert Ernst had not taken Vioxx long enough to be at any increased risk of heart trouble and that he died of cardiac arrhythmia, not a sudden heart attack or stroke.
A study sponsored by the US Food and Drug Administration estimated that Vioxx could have caused 27,785 heart attacks or deaths since it was approved in 1999. In February, an FDA panel determined that Vioxx did cause possible cardiovascular problems but narrowly voted to allow its return to the market.
AFP
Bayer launches Rapidlab
LEVERKUSEN, Germany
Bayer HealthCare Diagnostics Division recently launched Rapidlab 1200 analyzer, a high-throughput, low-maintenance blood-gas instrument designed to address key challenges facing today's laboratories. Delivering results for all test para-meters in about one minute and with minimal maintenance requirements, the Rapidlab 1200 automated blood-gas instrument provides the speed, accuracy, and "uptime" needed for clinical staff to make critical-care decisions in a timely manner.
The Rapidlab 1200 blood gas analyzer offers a comprehensive test menu, including pH, blood gas, electrolytes, metabolites, and CO-oximetry--all from a single sample--enabling a lab or point-of-care testing site to satisfy individual testing needs. Based on the same cartridge-based technology as Bayer's Rapidpoint 400 analyzer, the Rapidlab 1200 system eliminates unwieldy gas tanks and reagent bottles, minimizing maintenance requirements, and enhancing the analyzer's ease of use.
The Rapidlab 1200 also has an onboard automatic quality control (AQC) independent from internal instrument calibrators, which improves country-specific regulatory compliance initiatives and simplifies quality-control processes. When integrated with Rapidsystems connectivity solutions, laboratories benefit from centralized data control, system management, and improved regulatory compliance.
"The Rapidlab 1200 automated analyzer provides unparalleled ease of use combined with reliability and the outstanding service and support that have become synonymous with Bayer Diagnostics' blood-gas instruments," said Tom Warekois, senior vice president of global strategic marketing for Bayer HealthCare Diagnostics Division. "Our laboratory customers will measure the benefits of this analyzer with improved lab workflow, enhanced uptime and increased testing efficiencies."
Bayer Diagnostics' Rapidsystems is a comprehensive portfolio of blood-gas analyzers that includes the Rapidpoint 400/405 for point-of-care testing and the Rapidlab 1200 for high-volume and central labs. Rapidlink Critical Care Information Management System, Bayer's leading information solution, integrates these analyzers into a hospital's centralized information system, enabling better management of patient data, and providing enhanced remote control of the blood-gas analyzers.
Bayer Press
WHO taps web in war v. counterfeit
WASHINGTON
The World Health Organization is harnessing the power of the Internet in its war on the US$35-billion counterfeit-drug business with the setting up of a web-based rapid alert system.
"The rapid alert system communications network will transmit reports on the distribution of counterfeit medicine to the relevant authorities for them to take rapid countermeasures," the WHO Western Pacific regional headquarters said.
National health authorities and other partner agencies will be linked to the system.
"The rapid alert system will considerably strengthen our hand against the counterfeiters," said Budiono Santoso, WHO regional adviser in pharmaceuticals for the Western Pacific.
According to the WHO, between six and 10 percent of all medicines on the world market could be counterfeit, with estimated sales of more than US$35 billion a year. The problem is most serious in developing countries, including the Mekong River region of Southeast Asia.
The WHO said counterfeit medicines can bring prolonged illness or death as well as wastage of health-care resources, citing a study undertaken in Mekong countries in 2001, which indicated that more than one-third of antimalarial artesunate products in Cambodia, the Lao People's Democratic Republic, Myanmar, Thailand, and Vietnam contained no active ingredients. A follow-up study in 2004 showed that the situation had worsened, with 99 out of 188 artesunate samples found to be counterfeit."
"Effective measures to protect people from counterfeit drugs require collaboration and coordination among relevant stakeholders in each country, between member countries and relevant partner organizations," the WHO said.
According to WHO data, eight percent of drugs bought from pharmacies in the Philippines in 1999 were fake. In 2001, 64 percent of antimalarial pills collected in an investigation did not contain the active ingredient, and led to the death of patients in Vietnam. In 2003 national drug-testing laboratories in Phnom Penh and Bangkok looked at 230 samples of 24 pharmaceuticals purchased on the Cambodian market in 2000, including antibiotics and painkillers. About 3.5 percent of them contained less than 60 percent of the labeled quantity of active ingredient. When the study was repeated in 2003, 11 percent of the samples fell into this category, while some contained the wrong ingredient. In Nigeria and Pakistan, counterfeit drugs accounted for between 40 and 50 percent of the total market.
AFP
AstraZeneca names new CEO
LONDON
AstraZeneca announced it would replace its chief executive Tom McKillop, while reporting strong results for the second quarter. McKillop is to retire on January 1 and would be replaced by David Brennan, head of the company's US and Canadian operations, the group said.
Commenting on Brennan's appointment, Louis Schweitzer, AstraZeneca chair, said: "David has over 30 years experience in the pharmaceutical industry and has played an important part in the development of AstraZeneca. With his fine leadership qualities and a strong and talented management team, the board is confident that the company will continue to prosper."
The company's pretax profit rocketed 67 percent to US$1.718 billion during the three months to June 30, compared with the same period last year. At constant rates of exchange, profit surged 55 percent. Meanwhile, operating profit climbed 63 percent to US$1.718 billion, and increased 13 percent at constant rates of exchange.
"Strong sales growth and productivity gains have delivered an outstanding first-half performance leading to higher shareholder returns and an increase in financial targets for the full year," McKillop said. Group profits were bolstered by a strong performance of Nexium, Seroquel, and Crestor. Revenues rose 16 percent to US$6.13 billion as sales of Seroquel leapt 35 percent to US$667 million. Sales of Crestor rose 53 percent to US$317 million and Nexium sales climbed 33 percent to US$1.2 billion.
AFP
Sanofi gets to keep Plavix patent
PARIS
Sanofi-Aventis announced that British rival Aircoat had dropped a legal challenge seeking to remove patent protection for Plavix, one of the company's best-selling products. "Aircoat has withdrawn the revocation action by which it had sought to invalidate the Sanofi-Aventis patent in the UK," Sanofi said.
Scotland-based Aircoat started legal proceedings against Sanofi-Aventis in January in an attempt to overturn the patent for clopidogrel bisulfate, the main ingredient in Plavix. Plavix is taken by about 41 million people worldwide and is one of the most lucrative products in the portfolio of Sanofi-Aventis.
Two generic drug producers are currently challenging the
patent in the United States, where Sanofi-Aventis claims it has protection until 2011.
AFP
Novartis on buying binge
BASEL, Switzerland
The Swiss pharmaceutical giant Novartis said it had received the go ahead from the United States Federal Trade Commission (FTC) for its takeover of US-based generic maker Eon Labs. The move is part of a US$7.4-billion acquisition of Eon Labs and its German parent company Hexal agreed in February. The Swiss group is acquiring 67.7 percent stake in Eon Labs. Eon Labs and Hexal are to be absorbed by Novartis's generics arm, Sandoz.
Novartis said the FTC's consent was conditional on the divestment of three generic drugs, the antidepressant desmipramine, the painkiller orphenadrine citrate, and the antibiotic rifampin to the US company Amide Pharmaceutical.
Novartis chief executive Daniel Vasella is aiming to gain world leadership of the generics market with a market share of about 10 percent and combined sales of US$5.1 billion.
The company is also acquiring the rights to a portfolio of over-the-counter (OTC) products from Bristol-Myers Squibb for US$660 million in cash. It said the deal would significantly strengthen its OTC business in the US market.
Under the deal, which according to Bristol-Myers is expected to close by the end of September, Novartis is entitled to produce and market Bristol-Myer's North American OTC brand portfolio, led by the pain medicine Excedrin. The agreement also allows Novartis to sell those brands in Latin America, Europe, the Middle East, and Africa. These products posted combined sales of US$258 million in 2004, 90 percent of which were in the US. Excedrin accounted for US sales of US$160 million dollars in 2004.
Other brands acquired from Bristol-Myers include skin-care product Keri, nasal decongestant 4-Way, cold and flu medication Comtrex, sleeping pill No-Doz, antifungal cream Vagistat, systemic analgesic Bufferin, and topical analgesic Mineral Ice.
AFP
Low-carb Atkins goes bankrupt
NEW YORK
Low on carbs--and funds--Atkins Nutritionals Inc. (ANI), the company founded by low-carb-diet pioneer Robert Atkins, has filed for bankruptcy protection. The company said the filing in US Bankruptcy Court in New York marked the final step in efforts to reorganize the business, which has been hit by waning interest in the once phenomenally popular, meat lovers' diet. It listed assets of US$ 301 million and liabilities of US$325 million. The company secured US$25 million in financing to operate during the bankruptcy proceedings.
"In the past year we have adjusted our organization to accommodate a smaller business and have begun to position the Atkins brand more broadly for consumers who are concerned about health and wellness," said ANI president Mark Rodriguez.
ANI which sells its low-carb products in more than 30,000 stores across the United States and Canada, will focus its energy on its "core nutrition bar and shake portfolio," Rodriguez said.
Atkins, who founded ANI in 1989, died in April 2003 after slipping on some ice on the way to work. The New York medical examiner's report into Atkins's death said he had a history of congestive heart failure and hypertension--a diagnosis that helped fuel criticism of his dietary theories.
In a scientific review last year, The Lancet said the Atkins Diet lacked essential proof to show it is effective for more than a year and safe in the long term.
AFP
CMC unveils MRI from GSIS - 269 ARNEL
The Capitol Medical Center (CMC) unveiled on July 14 a new magnetic resonance imaging (MRI) system bought for the hospital by the Government Service Insurance System under its GSIS Hospitalization Support Program (GHSP).
The PhP54-million Hitachi Aperto 0.4 Tesla Open MRI System, which has the highest magnetic-field strength in its class, is an "open" magnet, which does away with the anxiety that patients experience with the traditional "enclosed" MRI systems.
Dr. Thelma Clemente, CMC president and chief executive officer, said "having the latest MRI technology positions CMC as one of the best equipped hospitals in the country."
Under GHSP, the state pension fund purchases equipment for selected hospitals. In turn, the hospitals provide GSIS members, dependents, and pensioners discount rates ranging from 30 to 50 percent on cost of hospitalization, medical procedures, and consultations. Active GSIS members get a discount of 50 percent on the use of a GSIS-sponsored equipment, 40 percent on common and 35 percent on special medical procedures, 30 percent on room and supplies and medicines, and 10 percent on professional fees.
"The program is advantageous to GSIS members because they enjoy substantial discounts while availing of quality and affordable medical service of top-caliber hospitals and medical professionals," said Winston Garcia, GSIS president and general manager. He said more than 2,400 GSIS members have benefited from the program since it was launched in June 2004, with discounts totaling PhP8.3 million.
Other hospitals that have benefitted from the GSIS program are the University of Santo Tomas Hospital, Lorma Medical Hospital in La Union, and Perpetual Succor Hospital in Cebu City.
A. Mendoza
SLMC opens mood-disorders clinic
St. Luke's Medical Center (SLMC) recently opened its mood-disorders clinic to provide diagnostic and treatment services for depression and other mood disorders.
Mood disorder is a chronic condition that if left untreated usually affects a person's ability to function. "That is the reason for the establishment of this clinic--for us to help identify individuals suffering from this condition and get back to their baseline level of function," said Dr. Ruby Manalastas, codirector of the hospital's Institute of Neurosciences
The World Health Organization says unipolar depression is the second leading health problem in the world today. It predicts that by 2020, the leading cause of death worldwide will be suicide. The illness manifests itself in a wide array of physical symptoms.
The exact causes of mood problems remain unknown. However, several factors have been associated with mood disorders, including genetic predisposition, brain-neurotransmitter dysregulation, early-childhood trauma, and medical conditions.
Manalastas pointed out that an initial laboratory work-up is performed to determine the reversible cause of depression. For example, hypothyroidism is usually associated with clinical depression, which is why treatment for the thyroid problem and depression must be initiated at the same time for proper management.
Manalastas said that for holistic management of patients, the clinic works closely with the different units of the hospital such as the stroke unit, geriatric center, hemodialysis unit, sleep-disorders center, and pain-management center. The clinic may be reached at +63-2-7230101, extension 4303.
Meanwhile, SLMC recently acquired the new 3 Tesla MRI device, which provides high-performance imaging in the most open, patient-friendly scanning environment. The 3 Tesla MRI is a sophisticated magnetic-resonance scanner with a very high signal-to-noise ratio, allowing it to deliver much clearer and more detailed images of the body. The enhanced contrast and higher resolution it offers reveal important details not easily visualized with other scanners. It also allows the use of thinner slices for a more accurate diagnosis. The system is ideal for brain and spine studies; vascular examinations; and body, cardiac, and muscoloskeletal imaging.
BFAD restricts drug promos
The Bureau of Food and Drugs (BFAD) no longer allows various forms of sales promotions involving prescription drugs.
In a memorandum issued on August 12 and approved by Director Leticia Barbara Gutierrez, the BFAD announced that it "shall no longer receive, process, and approve applications for permit to conduct promotions in any case involving prescription or ethical drug products." These include providing discounts for the purchase of these drugs, using coupons or returning empty drug packages in exchange for free additional medicines, and other consumer-targeted promos.
In addition, the use of such terms as "public-service announcement" or "public-health advisory" in connection with prescription drugs will be allowed only if the purpose is "to protect public interest and promote safety," and if the brand name is not mentioned. The memo added that these announcements should not "directly or indirectly advertise or promote the prescription of ethical drug products concerned, or other influence consumers in purchasing these drug products or encourage them to self-medication."
As for over-the-counter drug products, the BFAD said that it will only approve applications for sales-promotion campaigns if the known adverse effects are specifically cited in both the application and in the promotion itself. Giving certain rewards (such as a chance to travel abroad) in exchange for prescriptions or attachments to these prescriptions, as a part of the promotional campaign, is also prohibited.
The BFAD said that this memorandum was issued in response to "the rise of complaints relative to the conduct of advertisements and promotions" of prescription drugs.
The Pharmaceutical and Healthcare Association of the Philippines (PHAP), a self-regulatory organization made up of 87 local and international organizations from the pharmaceutical and health-care industry, is set to deliberate on the memorandum. Mr. Leo Wassmer Jr., executive vice president and chief executive officer of PHAP, told MEDICAL OBSERVER that the PHAP board is set to meet on August 31.
TARKA LAUNCH
With a Turkish-inspired theme, Abbott Laboratories recently launched Tarka, a fixed-dose verapamil and trandolapril combination for prediabetic and diabetic hypertensive patients, in a scientific symposium during which noted cardiologists Joel Abanilla, Jane Galang (first and third from left), Roberto Yabut, Ramon Abarquez Jr., and Loewe Go (fifth, fourth, and third from right), and nephrologist Helen Ocdol (second from left) gave insights on the features and benefits of the drug. They cited several clinical trials, especially the landmark INVEST and BENEDICT. The symposium, dubbed Cardiovascular Talk Show, had Drs. Rafael Castillo and May Ann Lao (sixth and seventh from left) as facilitators. Also in photo are Gemma Llamado (fourth from left), group product manager of Abbott Laboratories; Dr. Rebecca Castillo (fifth from left); Hudson Pelayo (second from right), product manager; and Roberto Taboada, business unit director.
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