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ADVERTISER: Bristol-Myers Squibb COMPLAINANT: Merck Frosst SUBJECT: c00-43 Avalide Detail Material PRECLEARANCE: yes ALLEGATIONS: The claim "Demonstrated greater efficacy than Coozaar + HCTZ" is misleading because it is based on a study that does not compare like doses s5.2 ; . PAAB DECISION: Sustained. The claim contravenes section 5.2 which states comparisons should be drawn between drugs under the same conditions of use e.g maximum vs maximum doses ; . This did not occur in the Oparil study. PENALTY: Withdrawal of PAAB clearance and cessation of distribution of the APS containing the claim. OUTCOME: Bristol-Myers Squibb Sanofi-Synthelabo agreed to cease distribution and evista. T the world congress of cardiology in barcelona in september, the headlines were all about studies showing an excessive incidence of thrombosis and mortality associated with the use of drug-eluting stents dess. Daily communication, both within the University and with community members and partners outside the University, is an essential component of the MERP. To that end, our entire current communications strategy assumes that externally provided telecommunications services will remain intact on a day by day basis. We assume we can rely on standard landline and cell phone networks to provide us with access to each other and to agencies outside the University. Similarly, we assume that externally provided internet infrastructure will be available to which our own servers can connect to provide access to the world at large to send and receive e-mail and to access public health websites for up to date information. If these assumptions can be extended into a period of prolonged Medical Emergency, Information Technology Services will, through its plan, provide sufficient redundancy in its provision for external connectivity that at least emergency communications via one provider or another will be maintained at all times. Included in our communications plan is the adoption of a Blackberry strategy that will link all of the University's senior administrators to each other and to all other Blackberry users worldwide. This particular form of wireless connectivity will provide a layer of information sharing internally and externally that will complement standard telephone, e-mail, and web services. The greater the redundancy in our planning, the greater the likelihood that something at least resembling normal electronic communications will be possible. Under such conditions, during a medical emergency, the role of the Manager, Telecommunications and Network Services will be a key one. Information Technology Services will ensure in its staffing plan for a medical emergency that this role will be continuously filled. 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It may seem paradoxical, but these very More than one hundred biotech expensive medicines can lower medicines are already on the your overall health costs by market, and hundreds more are Breakthrough science reducing the number of hospiin development. Until recently, with sky-high prices. talizations and delaying the biotechs targeted rare condiprogress of the disease. tions. However, new products How will you handle Managing biotech therapy can provide breakthrough treatment the coming biotech be challenging for participants, for asthma, psoriasis, and blockbusters? however. Every Caremark rheumatoid arthritis--diseases Specialty Pharmacy Services affecting millions of Americans. participant has a pharmacist-led And even one biotech patient in Care Team. Services include a population can have a serious verification of coverage and effect on your prescription drug complete coordination of care--education about the trend. Every decision you make regarding drug and disease and active, ongoing support with this category can have significant impact. overall management of the condition. Meeting the challenge--3 steps 1. Uncover hidden costs. Many biotechs are injectables, often administered in the hospital or physician's office, where health plans are likely to be charged premium prices. Integrating pharmacy claims data with medical claims can often identify Caremark is an expert in emerging therapies for serious chronic conditions. For in-depth information on Caremark Specialty Pharmacy Services, contact your Caremark account representative and cyclobenzaprine. The Health Products and Food Branch HPFB ; is considering a regulatory prohibition of specified risk materials SRMs ; in the manufacture of health products, which would likely have an impact on some veterinary drugs. Since in some circumstances, an unqualified prohibition may be inappropriate, these situations are being taken into consideration as we move forward with this initiative. For example, as in the Food SRM ban, health products which contain bovinederived materials from BSE-free countries could be exempt. Similarly, products containing SRMs shown to provide a therapeutic benefit which greatly outweighs the potential risks, could also be exempt. A Branch-wide common guidance policy dealing with the risk of transmission of Transmissible Spongiform Encephalopathies TSEs ; via Health Products will provide guidance for sponsors with respect to the interpretation of the prohibition and will also focus on other aspects relating to minimizing the possible risk of transmission of TSEs. This policy will contain productspecific appendices. VDD's draft Appendix - the portion of the policy that will most affect VDD's Stakeholders will be a part of the larger Branch-wide policy document. The finalization of the guidance document Minimizing the Potential Risk of Transmission of the Transmissible Spongiform Encephalopathy TSE ; Infectious Agent via Health Products depends on the outcomes of discussions concerning the details of the prohibition. There is a strong desire to move as quickly as possible with any proposed regulatory amendment. There will be opportunity to consult on this and related measures. VDD will keep stakeholders informed of any new developments!

1. Identification--A common and persistent protozoan disease of the genitourinary tract, characterized in women by vaginitis, with small petechial or sometimes punctate red "strawberry" spots and a profuse, thin, foamy, greenish-yellow discharge with foul odor. The disease may cause urethritis or cystitis but is frequently asymptomatic; it may also cause obstetric complications and may facilitate HIV infection. In men, the infectious agent invades the prostate, urethra or seminal vesicles; it often causes only mild symptoms but may cause as much as 5%10% of nongonococcal urethritis in some areas. Trichomoniasis often coexists with gonorrhoea, in some studies up to 40% of persons with gonorrhoea have concurrent trichomoniasis, and the majority of women with trichomoniasis also have bacterial vaginosis; a full assessment for STI pathogens "STI check" ; must be carried out when trichomoniasis is diagnosed. Diagnosis is through identification of the motile parasite, either by microscopic examination of discharges or by culture, which is more sensitive. The organisms can be seen on a Papanicolaou smear. PCR testing is available but is insufficiently reliable for routine use. 2. Infectious agent--Trichomonas vaginalis, a flagellate protozoan. 3. Occurrence--Widespread; a frequent disease, primarily of adults, with the highest incidence among females 16 35 years. Overall, about 20% of females may become infected during their reproductive years. 4. Reservoir--Humans. 5. Mode of transmission--Through contact with vaginal and urethral discharges of infected people during sexual intercourse. 6. Incubation period-- 4 20 days, average 7 days; many are symptom-free carriers for years. 7. Period of communicability--For the duration of the persistent infection, which may last years. 8. Susceptibility--Susceptibility to infection is general, but clinical disease is seen mainly in females. 9. Methods of control-- A. Preventive measures: Educate the public to seek medical advice whenever there is an abnormal discharge from the genitalia and to refrain from sexual intercourse until investigation and treatment of self and partner s ; are completed. Promotion of "safer sex" behaviour, including condom use, is recommended for all sexual contacts where mutual monogamy is not the case.

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