A "KOL" to improve patients' lives
More than the desire to have high-quality medicines and nutritional products is the desire to preserve and improve life. Wyeth Philippines considers this its guiding principle; with the establishment of an advisory board of "Key Opinion Leaders (KOL)," Wyeth Philippines is taking another step closer to this goal. On July 28, Wyeth Philippines gathered medical professionals at the Every Nation Leadership Institute at the Bonifacio Global City to launch its "pioneering" "First KOL Advisory Board."
Mr. Perpetuo de Claro, Wyeth Philippines president and general manager, reemphasized the company's mission of preserving and improving lives. "For us," he said, "the fulfillment of this commitment will need three building blocks: products, programs, and people."
Being a "heavily research-based company," he said, Wyeth has "a long track record of pioneering" pharmaceutical and nutritional products. These are then supported by programs that involve members of the organization and other stakeholders. Also involved are the patients that you and I care for." He stressed that these products and programs will not benefit patients and their families without "the work of great people," those who comprise the organization and the partners to the implementation of the various programs. Through collaboration, he said, these programs will be set in motion.
Collaboration is the main idea behind the First KOL Advisory Board. These KOLs will contribute valuable input in the development of programs for patients. They will play an important role in the exchange of ideas that will guide important decisions. Aside from being important resource persons in activities for continuing medical education, they will also participate actively in raising awareness among patients and providing them better treatment options.
Dr. Cornelio Banaag, one of the KOLs, said that being a part of the First KOL Advisory Board entails making a difference in the lives of patients. "Our patients are on the center stage," he stressed. "They are the ones that keep driving us to work harder, keeping us inspired to learn new things."
SLMC adopts new antibiotic policy
To help raise the standards of health care in the country, St. Luke's Medical Center (SLMC) began implementing in August a new antibiotic policy to assist physicians in choosing the most rational, safe, effective, and cost-efficient antimicrobials, promote judicious use, and minimize antibiotic resistance.
Dr. Celia Carlos, chair of SLMC's subcommittee on criteria-monitored drugs of the pharmacy and therapeutics committee, said the criteria-monitored antimicrobials (CMA) policy addresses antimicrobial resistance, one of the key issues in the management of infectious diseases worldwide.
"Based on evidence gathered from scientific litrerature, expert opinion and from existing treatment guidelines, the committee came up with a list of antibiotics with predetermined criteria for use," she explained. "With this policy, we hope the doctors at St. Luke's will be able to more appropriately prescribe the identified CMAs using established indications."
SLMC created the subcommittee on criteria-monitored drugs in August 2003 and tasked it to devise an improved antibiotic policy for the hospital based on scientific evidence. The policy is also a requirement of the Joint Commission International (JCI) under its quality-management and improvement policies. SLMC is the only hospital in the Philippines and one of only five in Asia that has been awarded JCI.
"Antibiotic policies have long been implemented in developed nation, and developing countries are beginning to do the same," Carlos said. The committee's list of CMAs include 17 antimicrobials: amikacin sulfate, ertapenem, imipenem + cilastatin sodium, meropenem, ceftazidime, cefepime hydrochloride, vancomycin, ztreonam, linezolid, piperacillin + tazobactam, ticarcillin clavulanate, gatifloxacin, levofloxacin, amphotericin B, fluconazole, and itraconazole.
Carlos said that narrowing the choice of CMAs to 17 would be better for patients in the long run so that they will not develop significant levels of resistance to these antimicrobials. "Physicians will be encouraged to prescribe first-line antimicrobials to patients first. If these fail, second-line antimicrobials, which are more potent, will then be administered," she explained.
The CMA policy will be initially implemented in four pilot units--nursery, cancer 1 and 2, and medical intensive care. These units were chosen because their patients are at high risk for infections.
"If the policy works in these four units, then it can be applied to the entire hospital," Carlos said. "The risk reduction and management committee will be tasked to monitor the implementation of the policy and we will monitor the results of the implementation. If it is necessary to modify the policy, we will do so after the initial three-month period."
Sanofi-Aventis posts profit gain
PARIS
Sanofi-Aventis posted second-quarter net profit of US$1.9 billion, a 26-percent rise from a year ago. Sales increased 6.5 percent to US$8.17 billion in the May-June period while operating profit rose to US$2.7 billion from US$2.2 billion a year earlier.
Jean-Francois Dehecq, Sanofi-Aventis chair, said that the group expected economies of scale worth US$1.9 billion in 2006 in res-ponse to its acquisition a year ago of Aventis.
In addition to its financial results, Sanofi provided an update on several compounds under development that are aimed at replenishing its portfolio of major drugs ahead of a projected sales decline for its top 15 products, set to begin from 2007.
Sanofi said the antidepressant SR 58611 showed positive results in only one phase-III study-280 patients in Europe--while the North American phase-III study showed no improvement compared with patients taking placebo.
The company also said it had dropped plans to develop Pranalcasan, a drug for arthritis, and Osanetant, a schizophrenia treatment. Both had been seen as potential future blockbusters. Sanofi has also decided to abandon Idraparinux, an oral blood-thinning drug that could have replaced Lovenox, the existing antithrombotic that faces generic competition in 2007.
Another drug, the SSR 591813 antismoking treatment, also saw good results in phase-IIb trials, but the potential for this treatment remained limited.
AFP
Salus, DCI team up for automation
It takes more than good intentions to overcome the challenges in the country's health-care delivery system. With over 41,000 rural health units (RHU) in the country, more takes place than just the service from medical and health professionals.
There are business requirements that have to be met as well as clinical ones. The administration and monitoring of health programs and services, tracking of qualified members and constituents, management of medicine and supplies inventory, billing and PhilHealth claims, and preparation of reports have to be taken care of properly.
However, "red tape" dominates the present system that takes care of these matters. Long lines, delayed payment of benefits, and frequent unavailability of funds for medical supplies are just a few of its shortcomings.
Corruption at the RHU level complicates matters further. Pilferage is also a big problem, adds Chris Stolk, Salus Healthcare Information Inc. president and chief executive officer. "Statistics will prove that a lot of taxpayers' money, or even donations from drug companies to public hospitals/rural health units, are lost to pilferage, or just because of neglect, medicines expire," he said.
Facing such a dragon of a problem may need more than just the government's efforts, which have proved inadequate and its own undoing in many cases. The government may need to draw from the powers of information technology to improve its health-care system.
In August, the government, represented by DBP Data Center Inc. (DCI), teamed up with Salus for IT solutions that will lead to the automation of the public-health-care system's processes and transactions. For starters, DCI and Salus aim to connect the RHUs to public-health hospitals through e-Gov Health Solutions, an operations and management solution that allows health-care facilities and providers to electronically manage and integrate vital medical information and transactions.
According to DCI, this will enable health-care providers to access a patient's medical history from multiple sites. It will also allow medical and health professionals to manage their clinics better by integrating most operations and enable doctors to consult on cases, share information, and provide ideas and insights in real time.
Andrew Guitarte, executive vice president and chief operating officer of Salus, explained that ultimately, the goal of this partnership is to alleviate poverty in the Philippines by providing local government units "with a system to help achieve sustainable and effective delivery of health programs and services."
And given that government health-care expenditures represent just about one percent of the national budget, this system would enable health-care facilities to do more with less, Stolk pointed out.
Salus is a technology solutions provider that offers products and services specifically developed for hospitals, clinics, pharmacies, health-maintenance organizations, insurers, pharmaceutical firms, and medical professionals.
DCI is a wholly owned subsidiary of the Development Bank of the Philippines that over the past 22 years has evolved into an integrated IT-driven company.
M. Ciriacruz
FDA to Pfizer: Stop misleading Zyvox ad or face seizure
The United States Federal Drug Administrtion (FDA) has asked Pfizer Inc. to stop its "misleading and unsubstantiated" advertisement for linezolid (Zyvox), an antibiotic, or face more serious regulatory action, "including seizure or injunction."
In a July 27 warning letter sent to Henry McKinnell Jr., Pfizer chief executive officer, the FDA division of drug marketing, advertising, and communications (DDMAC) said the Zyvox ad implies superiority without evidence, broadens the indication for Zyvox, fails to reveal important risk information associated with its use, and lacks fair balance.
The letter, signed by DDMAC director Thomas Abrams, said the ad violated certain provisions of the United States Code and implementing regulations issued by the FDA.
"Your misleading promotion of Zyvox, and in particular, your unsubstantiated implied claims regarding its superiority to vancomycin, poses serious public-health and safety concerns because of its potential to result in the inappropriate use of Zyvox, which is associated with increased toxicity relative to vancomycin," Abrams wrote.
Going beyond approved indication
The FDA said the ad's headline--"MRSA meets its match"--is misleading and because it implies that Zyvox is useful in all infections caused by methicillin-resistant Staphylococcus aureus (MRSA) "when this has not been demonstrated by substantial evidence or substantial clinical experience." The FDA noted that this claim broadens the indications for Zyvox beyond what the drug-regulatory agency has approved.
Zyvox is approved for treatment of complicated skin and skin-structure infections, including diabetic foot infections, without concomitant osteomyelitis. It is also indicated for nosocomial pneumonia and caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains (MDRSP).
Abrams said that while these indications were included "in very small type size at the bottom of the third page of the ad, [it] does not correct the misleading suggestion conveyed by the ad as a whole that Zyvox is indicated for the treatment of all MRSA infections."
Unsubstantiated "superiority" claim
The FDA also noted while Pfizer took pains to present "two identical, randomized, double-blind, and prospective studies retrospectively analyzed" to imply superiority to vancomycin, the data do not constitute substantial evidence or substantial clinical experience.
Abrams said the studies Pfizer presented were not two adequate and well-controlled studies but one study conducted prior to marketing and continued as a postmarketing study. He noted that the presentation in the ad is based on a posthoc subgroup analysis in which, p values are meaningless and cannot be used to demonstrate statistically significant differences between treatment groups. "When looking for differences between treatment groups, the study must be designed to look for these differences prospectively, and must be sufficiently powered. The studies you present in the ad were not designed in this way," he told McKinnell.
Failure to disclose risks
The FDA also noted that the main part of the ad presents effectiveness claims for Zyvox such as "A Proven Therapy Deserves a Closer Look," "Serious Infection; Serious Results," and "MRSA meets its match," but fails to reveal important risk information associated with its use, especially in the light of the ad's suggestions for broader indications.
The agency cited Pfizer's failure to include "bolded warnings" concerning the risk of myelosuppression, lactic acidosis, and spontaneous reports of serotonin syndrome. Zyvox's approved product information states in part: "Lactic acidosis has been reported with the use of Zyvox. In reported cases, patients experienced repeated episodes of nausea and vomiting. Patients who develop recurrent nausea or vomiting, unexplained acidosis, or a low bicarbonate level while receiving Zyvox should receive immediate medical evaluation." The ad also fails to include additional precautions regarding peripheral and optic neuropathy, the FDA added.
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The agency also said the ad lacked "fair balance" because it fails to present the risk information "with a prominence and readability reasonably comparable to the presentation of effectiveness information." It noted that effectiveness claims for Zyvox were presented using large, colorful, bold headers and a colorful chart while all of the risk information was presented in very small font in a single-spaced paragraph at the bottom of the page without additional elements that indicate to the reader that it is important risk information.
Apart from asking Pfizer to stop using the ad, the FDA also required the company to take steps to correct the misleading ad by issuing truthful information. "Because the violations … are serious, we request further that your submission include a comprehensive plan of action to disseminate truthful, nonmisleading, and complete corrective messages," the letter said.
The FDA gave Pfizer until August 3 to respond to the warning and institute corrective measures. Reuters reported Pfizer press officer Daniel Watts as saying, "Pfizer will immediately take steps to cease distribution of the professional advertisement cited by the FDA."
As this issue went to press, however, the FDA has not posted in its web site any reply from Pfizer. No official statement could also be obtained from Pfizer's web site.
J & J takeover of Guidant cleared
BRUSSELS
The European Union's executive commission has cleared US health conglomerate Johnson & Johnson's takeover of Guidant Corp., maker of medical devices, on the condition that some businesses are sold.
After an in-depth investigation to see if the merger would harm competition in the sector in Europe, EU regulators concluded that the US$23.9-billion deal could go ahead on condition that the companies agreed to sell off some cardiovascular medical treatments.
In particular, the commission called on the two companies to sell either Johnson & Johnson's or Guidant's endoscopic vessel-harvesting products, plus Guidants endovascular business and Johnson & Johnson's steerable-guidewires business.
"I wanted to ensure that consumers would not have to pay higher prices for the life-saving medical devices produced by these two companies and that any changes to the competitive structure in these markets would not be to the detriment of consumer welfare," said Neelie Kroes, EU competition commissioner. "I am therefore satisfied that the commitments given by J & J allow the Commission to approve this merger," she added.
Johnson & Johnson is in the midst of closing its acquisition of Guidant in a cash and stock deal, which is expected to be completed by the end of September.
AFP
GSK buys Canada's ID Biomedical
LONDON
GlaxoSmithKline (GSK) announced it has reached an agreement to buy ID Biomedical, a Canadian maker of flu vaccines, for about US$1.43 billion. Under the terms of the agreement, ID Biomedical would become a wholly owned subsidiary of GSK. Shareholders of ID Biomedical will be entitled to receive 35 Canadian dollars per share.
Glaxo said its offer represented a premium of 13 percent over the closing price of the shares on September 6 and a premium of 30 percent over the 20-day average share price.
"GSK will also assume responsibility for ID Biomedicals net debt, which was US$77 million at June 30, 2005. In addition, on execution of the agreement, GSK has agreed to loan ID Biomedical up to 120 million US dollars to repay term debt and finance its cash requirements to the anticipated closing date."
The acquisition has been approved unanimously by both companies' boards of directors, though the deal remains subject to the approval of ID Biomedicals shareholders and regulatory clearances.
Should all hurdles be passed, the transaction was expected to close by the end of 2005 or early 2006, GSK added.
"The proposed acquisition of ID Biomedical is a unique strategic opportunity to increase current capacity of classic flu vaccines, to provide us with increased capacity for next generation flu vaccines under development and to help GSK prepare for the threat of a flu pandemic," GSK chief executive Jean-Pierre Garnier said.
AFP
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