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Study was significantly influenced by several situations where clinical investigations were not commenced for many years after the composition and its end use were known, and jumps to 11.6 years when these situations are eliminated. PMA claims that this observation is irrelevant since the patent extension legislation would restore only such time as is lost after the patent issues. Significantly, in disputing the relevance of this finding, PMA is in the embarrassing position of disputing one of the key findings in the Eisman and Wardell study on which it has so heavily 9 relied until this point. That study concluded that the starting date of clinical testing is an important factor which influences effective patent life. Wardell also found that for the twelve-year period from 1968 to 1979, for unknown reasons, declining effective patent life can be explained, in part, by a later starting date for clinical testing in relation to the patent application filing date. Rep. Albert Gore, Jr. D-Tenn. ; has correctly observed that these facts demolish PMA's argument that the decline in effective patent life is due solely to delay caused by regulatory review. Clearly, the search for the definition of "effective patent life, " or the belief that meaningful statistics may be developed to establish that it is shrinking as a result of government regulation, is an exercise in futility. Each product has its own unique development, commercialization, and patent history, which makes any generalization in this area highly suspect. An average effective patent life figure which is derived solely by subtracting the NDA approval date from the patent expiration date without considering that history has no validity. The Proposed Legislation Is Seriously Defective Senate Bill S. 255 provides that " . the term of a patent which encompasses within its scope a product, or a method for using a product, subject to a regulatory review, shall be extended by the amount of time equal to the regulatory review " The term "regulatory review" is defined as the date of initiation of a "major health or environmental effects test, " a term defined as an experiment which requires at least six months to conduct. Accordingly, with respect to therapeutic compositions, the extension period would usually commence with the long-term animal toxicity test which precedes the human clinical investigation phase of drug development. The legislation also provides that the regulatory review period will not be deemed to have started until the patent is actually granted, even though tests which would qualify as regulatory review tests were started prior to that date. Finally, the legislation would go into effect immediately for all therapeutic compositions currently under "regulatory reveiw, " although the starting date for measuring the length of the extension.
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17. National Public Radio Kaiser Family Foundation Kennedy School of Government. Sex Education in America: Principals' Survey. Menlo Park, CA: Kaiser Family Foundation; 2004 18. Haag P. Voices of a Generation: Teenage Girls on Sex, School, and Self. Washington, DC: American Association of University Women Educational Foundation; 1999 19. Rideout V. Generation Rx : How Young People Use the Internet for Health Information. Menlo Park, CA: Kaiser Family Foundation; 2001 20. Donnerstein E. The Internet. In: Strasburger VC, Wilson BJ, eds. Children, Adolescents, and the Media. Thousand Oaks, CA: Sage; 2002: 301321 21. Malamuth N, Huppin M. Pornography and teenagers: the importance of individual differences. Adolesc Med Clin. 2005; 16: 315326 Strasburger VC. Tuning in to teenagers. Newsweek. May 19, 1997: 18 Gentile DA, Oberg C, Sherwood NE, et al. Well-child visits in the video age: pediatricians and the American Academy of Pediatrics' guidelines for children's media use. Pediatrics. 1004; 114: 12351241 Young TL, Zimmerman R. Clueless: parental knowledge of risk behaviors of middle school students. Arch Pediatr Adolesc Med. 1998; 152: 11371139 Hauser D. Five Years of Abstinence-Only-Until-Marriage Education: Assessing the Impact. Washington, DC: Advocates for Youth; 2004. Available at: advocatesforyouth publications stateevaluations index . Accessed September 20, 2005 26. Borawski EA, Trapl ES, Lovegreen LD, Colabianchi N, Block T. Effectiveness of abstinence-only intervention in middle school teens. J Health Behav. 2005; 29: 423 Santelli J, Ott MA, Lyon M, Rogers J, Summers D, Schleifer R. Abstinence and abstinence-only education: a review of U.S. policies and programs. J Adolesc Health. 2006; 38: 72 American Academy of Pediatrics, Committee on Public Education. Media education. Pediatrics. 1999; 104: 341343 McCannon R. Adolescents and media literacy. Adolesc Med Clin. 2005; 16: 463 Gigi Durham M. Attitudes About Television, Sex and Contraception Advertising. New York, NY: Planned Parenthood Federation of America; 1987 31. Kaiser Family Foundation: Condom ads on TV: unwrapping the controversy. Available at: kaisernetwork health cast hcast index ?display detail&hc 246. Accessed September 20, 2005 32. Abma JC, Martinez GM, Mosher WD, Dawson BS. Teenagers in the United States: sexual activity, contraceptive use, and childbearing, 2002. Vital Health Stat 23. 2004; 24 ; : 1 48 33. Sellers DE, McGraw SA, McKinlay JB. Does the promotion and distribution of condoms increase sexual activity? Evidence from an HIV prevention program for Latino youth. J Public Health. 1994; 84: 19521959 Wolk LI, Rosenbaum R. The benefits of school-based condom availability: cross-sectional analysis of a comprehensive high school-based program. J Adolesc Health. 1995; 17: 184 Furstenberg FF Jr, Geitz LM, Teitler JO, Weiss CC. Does condom availability make a difference? An evaluation of Philadelphia's health resource centers. Fam Plann Perspect. 1997; 29: 123127 Guttmacher S, Lieberman L, Ward D, Freudenberg N, Radosh A, Des Jarlais D. Condom availability in New York City public high schools: relationships to condom use and sexual behavior. J Public Health. 1997; 87: 14271433 Jemmott JB III, Jemmott LS, Fong GT. Abstinence and safer sex: HIV risk-reduction interventions for African American adolescents. JAMA. 1998; 279: 1529 Schuster MA, Bell RM, Berry SH, Kanouse DE. Impact of a high-school condom availability program on sexual attitudes and behaviors. Fam Plann Perspect. 1998; 30: 6772 Kirby D, Brener ND, Brown NL, Peterfreund N, Hillard P, Harrist R. The impact of condom distribution in Seattle schools on sexual behavior and condom use. J Public Health. 1999; 89: 182187 Blake SM, Ledsky R, Goodenow C, Sawyer R, Lohrmann D, Windsor R. Condom availability programs in Massachusetts high schools: relationships with condom use and sexual behavior. J Public Health. 2003; 93: 955962 Sharigan S. TV's last taboo. Available at: prospect print V12 8 sharigian-s . Accessed July 21, 2005 42. Snowbeck C. FDA tells Levitra to cool it with ad. Business News, Post-Gazette . Available at: post-gazette pg 05109 490334 m. Accessed on July 20, 2005 43. Collins RL, Elliott MN, Berry SH, et al. Entertainment television as a healthy sex educator: the impact of condom-efficacy and naprosyn.
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Saatchi scores Levitra creative account Disciplined mix for SAATCHI & SAATCHI Con- cies that were pitching.A spokes- next Crestor effort sumer Healthcare has won cre- woman for CommonHealth deative duties for Levitra, which is co-promoted by Schering-Plough and GlaxoSmithKline. The estimated million account was in review for several weeks last fall. CommonHealth's Quantum previously held the account, but was not listed among the agenclined to comment on the review. Along with Publicis Groupe's Saatchi, the finalists were Omnicom Group's BBDO and Merkley + Partners, both in New York. DDB, another Omnicom shop, initially pursued the business but withdrew before final presentations, according to reports. A GSK executive, in a presentation last fall, conceded missteps in the consumer marketing of Levitra, noting that the decision to launch the ED drug with unindicated reminder ads proved dubious. The executive acknowledged that GSK and Bayer were surprised by the positive reaction to Cialis' fully branded ads, complete with risk language warning of "erections lasting longer than four hours." --Tracy Krisanits IN THE WAKE OF new safety issues, AstraZeneca has disclosed plans for a upcoming DTC initiative for Crestor. Noting rapid growth in the U.S. statins market, chief financial officer John Symond told analysts there will be a "disciplined" approach to a marketing mix that carries significant investment in the new Crestor campaign. Symond attributed the growth to promotion efforts for this drug class and lower LDL levels recommended for patients. Meanwhile, Public Citizen Health Research Group director Sidney Wolfe said in a letter to the FDA that Crestor "is uniquely toxic without offering any unique benefit.
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Synopsis A pooled analysis of two phase III studies involving 1479 men, presented at the World Congress on the Ageing Male shows that while vardenafil Levitra ; works quickly and lasts up to 12 hours, this may not be the case all of the time. The analysis showed that only 52% to 64% men who took the 5, 10 or 20 mg doses and attempted to have sexual intercourse after 15 minutes were successful. Nearly nine in ten attempts actually occurred in the first 2 hours after dosing, with a success rate ranging from 59% to 70% for all three doses. The success rate among the few men who attempted intercourse 8 to 12 hours after dosing ranged from 64% to 86.
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Figure 3. 1H-NMR spectra of unknown compounds: a ; 1H-NMR spectrum of 1 in Product A, 1 b ; H-NMR spectrum of 2 in Product B, c ; H-NMR spectrum of 3 in Product C. The C-NMR spectrum shows all the characteristic resonances for a 1-substituted [3- 6, 3-d]pyrimidin-5-yl ; -4-ethoxyphenyl structure element. Compared with sildenafil, the phenyl carbons show minor shifts, which is also indicative of a different substituent. The presence of a ketonic C O is clear from the absorption at 194.9 ppm. Quantitative NMR analysis showed that sample A contained approximately 15% w w ; of acetildenafil, which corresponds to 63 mg capsule. The IR spectrum shows peaks at 3315, 1697, 1604, and 1030 cm-1. Bands, which could be attributed to a sulphonamide, are absent. Sample B, compound 2 Based on the LC-ESI-MSn and 1H- and 13C-NMR data described below, the unknown compound was identified as a sildenafil analogue, in which the N-methylpiperazine moiety is substituted by N-ethylpiperazine figure 1 ; . Sample B was analysed for sildenafil. Although a peak is observed showing retention time and ultraviolet light spectrum comparable with sildenafil table 1 ; , the MS1 spectrum does not show an ion at m z 475 representing [M + H] sildenafil; however, an ion at m z 489 is present. Although this corresponds to the molecular mass of vardenafil, the active substance of Levitra, a relatively new medicine for erectile dysfunction, its retention behaviour on this chromatographic system and ultraviolet light spectrum are different Bakker et al. 2004 ; . MS2 spectra of [M + sildenafil m z 475 ; and of the unknown compound m z 489 ; were obtained figure 2a, c ; . Both spectra show signals at m z 377, 313, 311 and 283. According to the fragmentation pathway proposed by Zhong et al. 2002 ; , these ions lack the piperazine moiety. As the MS3 spectra of m z 377 of both compounds are comparable figure 2e, f ; , this part of the molecule in both compounds is similar, suggesting that the difference of 14 amu -CH2- ; should be in the piperazine moiety. The formation of m z 461.
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