MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'gardasil'. Sat, 03 Sep 2011 01:50:51 +0100 http://www.medworm.com/index.php?rid=5159832&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMZZz09zPr9Q%2F Despite strong endorsements from public health officials, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens, according to the Centers for Disease Control and Prevention. The two vaccines approved to combat the human papillomavirus are Gardasil, which is sold by Merck, and Cervarix, which is sold by GlaxoSmithKline. To be specific, coverage was 49 percent for one dose of HPV vaccine; 63 percent for MenACWY, which protects against meningococcal meningitis; and 69 percent for the TDP vaccine, which guards against tetanus, diptheria and pertussis. Meanwhile, coverage increases for Tdap and MenACWY vaccines grew 13.3 percent and 9.1 percent, respectively. For girls who received the recommended three doses of HPV vaccine, covera... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159832 Fri, 26 Aug 2011 12:25:02 +0100 5159832 http://www.medworm.com/index.php?rid=5159835&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FQexqt8C-1RI%2F A new analysis of more than 1,000 medical journal articles found that relatively few health problems are caused by or clearly associated with vaccines, according to a report released today by the Institute of Medicine. An expert committee reviewed scientific literature on possible side effects and found what it calls convincing evidence that vaccines can cause 14 specific adverse events - such as seizures, brain inflammation and fainting - but concluded that these occur rarely. “What we found is that there is very little evidence that vaccines cause adverse events, and most of the adverse events that there is evidence for tend to be time-limited,” Ellen Wright Clayton, director of the Center for Biomedical Ethics and Society at Vanderbilt University and the IOM committe chair, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5159835 Thu, 25 Aug 2011 17:20:13 +0100 5159835 http://www.medworm.com/index.php?rid=5107630&cid=t_100786_111_f&fid=39123&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2Fnursingcomments%2Ftdtc%2F%7E3%2Ff1LdsDd7wdc%2F I was getting my son’s physical for school the other day and the doctor talked to us about HPV.  What is it?  HPV, or humanpapilloma virus, is a very common sexually transmitted virus.  In fact, it is the most common sexually transmitted virus in the United States today.  More than half of sexually active men and women are infected with HPV at some time in their lives.  The good news is that there is now a vaccine called Gardasil to protect you from this sometimes deadly virus.  Gardasil use to be given only to young women, but now it is recommended for girls, ages 11-26 AND males, ages 9-26.  It is important to note that the vaccine is given before any sexual contact, because once someone is infected, the vaccine might not work as well or might not work at all.  Women with the v... Nursing Comments blogs http://www.medworm.com/rss/comments.php?id=5107630 Sun, 07 Aug 2011 16:11:00 +0100 5107630 http://www.medworm.com/index.php?rid=5078028&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FeXH08oXg61s%2F As if Merck does not have enough problems with vaccine production, the drugmaker apparently distributed charred bits of plastic shrink wrap in vials of various vaccines - including Gardasil for preventing HPV infection, Varivax for chicken pox, Pneumovax for pneumococcal disease, Zostavax for shingles and MMR II for measles, mumps and rubella, according to Dow Jones. In 2008, the FDA issued a warning letter about manufacturing problems at Merck’s West Point, Pa., plant (read here). Since then, FDA inspection reports have cited more problems: the presence of metal particles in certain products, cracks in vaccine vials and delays in Merck’s reporting adverse event from products made at the plant to the FDA, Dow Jones writes. The drugmaker maintains most problems have been resolve... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=5078028 Fri, 29 Jul 2011 18:09:05 +0100 5078028 http://www.medworm.com/index.php?rid=4992991&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FrcQNRvANhJM%2F Once again, the vaccines for thwarting HPV, notably Merck’s Gardasil, are causing a stir. In the latest dust up, the California Catholic Conference is urging state residents to contact their legislators to oppose a bill that would remove parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although California law already allows children 12 and older to consent to treatment for sexually transmitted diseases without involvement from their parents, the proposed bill would expand that right to immunizations (read the bill here). In an action alert, the bishops’ group warns parents that “minors do not have adequate judgment to make a decision about a vaccine that as of January 15, 2011, had 21,171 adverse reactions and 91 deaths report... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4992991 Fri, 01 Jul 2011 15:10:17 +0100 4992991 http://www.medworm.com/index.php?rid=4968907&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgdMwJhmfSyI%2F At the end of 2009, Julie Gerberding stepped down as director of the US Centers for Disease Control and Prevention to become president of Merck’s vaccine division. The move came a period of tumult, given that vaccine sales had dropped 2 percent amid manufacturing woes and controversy over the safety and marketing of the Gardasil vaccine for HPV, which can cause cervical cancer. The challenges remain. The Merck vaccine division makes 14 of the 17 vaccines recommended by CDC for children and nine of the 10 recommended for adults. Nonetheless, Gerberding keeps a relatively low profile, but spoke earlier this week with Xconomy about innovation and funding for the Global Alliance for Vaccines and Immunizations (back story). An excerpt of their conversation is below. However, she does not addr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4968907 Fri, 24 Jun 2011 12:47:08 +0100 4968907 http://www.medworm.com/index.php?rid=4848150&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FpzooZ2Wh0sg%2F Early last year, Merck sales rep David Turkheimer was instructed by his supervisor to tell a doctor that his patients would die if he did not prescribe the Gardasil HPV vaccine. The rep was was also told to inform another doc that his insurance rates would drop if Gardasil was prescribed. But he refused to do so and told his supervisor that such statements might run afoul of the FDA. That’s when Turkheimer allegedly ran into difficulty, according to a lawsuit he filed earlier this month against the drugmaker. He claims his persistant refusals prompted his supervisor to search for ways to terminate his employment. And his supervisor came up with an interesting rationale - he cited a car accident that Turkheimer insists was actually a medically induced episode of sleepdriving. Here&#8... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4848150 Fri, 20 May 2011 15:53:56 +0100 4848150 http://www.medworm.com/index.php?rid=4820859&cid=t_100786_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2011%2F05%2F11%2Funited-nations-push-to-vaccinate-every-female-for-hpv%2F For anyone keeping up on the statistics of growth in the vaccine industry, the income generated, and trends, here are some overwhelming facts: Global vaccine sales in 2010: $28 Billion Best selling vaccine in 2010: Pandemic influenza with $5 Billion in sales Second best-selling vaccine in 2010: Hepatitis B [it’s injected into newborn infants] HPV vaccine Gardasil® had $1.35 Billion in sales Top vaccine makers: GSK, Sanofi Aventis, Pfizer, Merck, and Novartis The pharmaceutical trade group PhRMA says there are 145 new vaccines in Research & Development Most promising vaccines: Cancer vaccines and vaccines for allergy, asthma, and smoking cessation are potential blockbusters. http://knol.google.com/k/krishan-maggon/global-vaccine-market-2010/3fy5eowy8suq3/152#   Projected sales... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4820859 Thu, 12 May 2011 04:51:47 +0100 4820859 http://www.medworm.com/index.php?rid=4762936&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FAEspvdtrmw4%2F Less than a month after the FDA refused to approve the Gardasil vaccine for preventing HPV in women ages 27 to 45, Health Canada has gone in the other direction and issued an endorsement. Although Canada is a smaller market than the US, the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue. In the US, Merck has been repeatedly frustrated in trying to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story). In Canada, Gardasil is now approved to... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4762936 Thu, 28 Apr 2011 16:32:43 +0100 4762936 http://www.medworm.com/index.php?rid=4684762&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FxvsJhjRYHqc%2F In a setback to Merck, the FDA has refused to approve the use of the Gardasil vaccine for preventing HPV in women ages 27 to 45, a market the drugmaker has been counting on to boost sorely needed vaccine revenue. In a brief statement, Merck says prescribing info was updated to indicate Gardasil has not demonstrated to prevent HPV-related cervical cancer in women older than 26. The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. Last year, the FDA postponed a decision about approval for women ages 26 to 45 after Merck had submitted additional data. The submission was made after the agency three years ago refused to approve the vaccine for this same age bracket and, instead, sought data on a 48-month study (back story). The vaccine is already approved ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4684762 Wed, 06 Apr 2011 22:11:21 +0100 4684762 http://www.medworm.com/index.php?rid=4642052&cid=t_100786_139_f&fid=38879&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FVirologyBlog%2F%7E3%2FsCXkxV-UUWQ%2F Hosts: Vincent Racaniello, Dickson Despommier, Alan Dove, Rich Condit, and Michelle Ozbun On episode #126 of the podcast This Week in Virology, virologist Michelle Ozbun and the TWiV team review the biology of human papillomaviruses. Click the arrow above to play, or right-click to download TWiV #126 (69 MB .mp3, 96 minutes). Subscribe to TWiV (free) in iTunes , at the Zune Marketplace, by the RSS feed, by email, or listen on your mobile device with the Microbeworld app. Links for this episode: Human papillomavirus page at CDC Human papillomavirus vaccines page at CDC A better test for HPV (pdf) Human papillomaviruses and malignancy (review) Should smallpox stocks be destroyed? (poll at virology blog) TWiV on Facebook Letters read on TWiV 126 Weekly Science Picks Michelle –... virology blog blogs http://www.medworm.com/rss/comments.php?id=4642052 Sun, 27 Mar 2011 15:43:44 +0100 4642052 http://www.medworm.com/index.php?rid=4540567&cid=t_100786_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fnew-study-links-hpv-to-head-and-neck-cancers-in-men%2F2011.03.02 A new study finds that half of men in America are infected with the HPV virus. Dr. Jon LaPook reports on the growing concern that the virus in men could be responsible for an increase in head and neck cancers. HPV Affects Half Of U.S. Men A study out [yesterday] in The Lancet by Moffitt Cancer Center researcher Anna Giuliano, Ph.D., and her colleagues finds that 50 percent of men ages 18 to 70 in Brazil, Mexico, and the U.S. have genital infection with human papillomavirus (HPV).  HPV is the virus that causes cervical cancer in women. It also causes warts and cancer of the genitals and anus in both men and women. Over the past several years, researchers have realized that the virus can also cause cancer of the head and neck. Aimee R. Kreimer, Ph.D., of the National Cancer Institute, ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4540567 Wed, 02 Mar 2011 16:00:34 +0100 4540567 http://www.medworm.com/index.php?rid=4446036&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FjcEW-wZX9A8%2F Hello, everyone, and nice to see you again. We hope the weekend was refreshing and interesting. Now, of course, the routine returns as those meetings and deadlines beckon. To cope, we are brewing our usual cup to stimulation - our flavor today is Gingerbread - and invite you to join us. Or grab a bottle of water, if you prefer. Meanwhile, here are a few tidbits to help you get started. Hope your day goes well and do stay in touch… AstraZeneca And Wellpoint To Conduct CE Studies (Dow Jones) Glaxo To Pay $250M To Resolve Avandia Lawsuits (Bloomberg News) Canada Debates HPV Vaccines For Boys (CTV) Pfizer Will Buy Danish Consumer Health Business (Associated Press) Roche Says Turkish Price Cuts Hurt Investment (Bloomberg News) Glaxo Updates Avandia Labeling (Associated Press) AstraZeneca ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4446036 Mon, 07 Feb 2011 12:54:46 +0100 4446036 http://www.medworm.com/index.php?rid=4433105&cid=t_100786_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-link-between-oral-sex-and-head-and-neck-cancer%2F2011.02.03 USA Today published a pretty accurate article regarding the rise of certain head and neck cancers with the increased popularity of oral sex and number of sexual partners. The factor that creates this link is the human papillomavirus (HPV) which is associated with tonsil and tongue cancer. Alcohol and tobacco use is more highly linked with such oral cancers, but HPV does appear to be an independent risk factor. A 2007 study in the New England Journal of Medicine found that younger people with head and neck cancers who tested positive for oral HPV infection were more likely to have had multiple vaginal and oral sex partners in their lifetime. Having six or more oral sex partners over a lifetime was associated with a 3.4 times higher risk for oropharyngeal cancer — cancers of the base ... Better Health blogs http://www.medworm.com/rss/comments.php?id=4433105 Thu, 03 Feb 2011 14:00:00 +0100 4433105 http://www.medworm.com/index.php?rid=4433330&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZnvAWxo_J08%2F Rise and shine, everyone. Another day is on the way. And here on the frosty Pharmalot corporate campus we are bounding with energy thanks to the ritual cup of stimulation, or three. The special flavor today is Golden French Toast. Of course, this makes it all the more possible to hunt down those interesting tidbits. Here are a few to help you get started. Hope your day goes well and do stay in touch… Komen Advocacy Group Is Cautious On Avastin (Wall Street Journal) Merck 2011 Misses Estimate And Takes $1.7M Drug Write-Off (Bloomberg News) Teva Receives FDA Warning Letter For Jerusalem Plant (Reuters) Merck’s Gardasil Prevents HPV And Genital Warts In Men (Bloomberg News) Glaxo Profits Slump On Legal Costs And Avandia Slowdown (PharmaTimes) Painkiller Prescription Errors Due To ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4433330 Thu, 03 Feb 2011 13:12:59 +0100 4433330 http://www.medworm.com/index.php?rid=4377790&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FfND27RYyNr4%2F The Internet may be ubiquitous, but to what extent do consumers trust the growing numbers of web sites catering to corporate messages, specific meds and disease information? To quantify this growing morass, a research firm asked more than 6,600 US adults in last year’s fourth quarter for their reactions to various sites and the available information, and here is what they found… When it comes to corporate websites, 37 percent expressed trust “to some degree” and 17 percent reported a lack of trust, with everyone else feeling neutral. Web sites for specific meds generated a slightly higher level of trust with 41 percent feeling comfortable and 14 percent expressing a lack of trust. As for disease sites, 37 percent viewed the site as trustworthy and 15 percent did not... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4377790 Thu, 20 Jan 2011 14:09:15 +0100 4377790 http://www.medworm.com/index.php?rid=4285353&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fj_8GX6iXEFk%2F The holiday weekend may be in the offing, but the Pharmalot corporate campus is still humming. And why not? The world has not stopped spinning, after all, and there is always something interesting going on. So while you prepare for a celebration or simply slow down the usual pace, here are a few items to help you along. Meanwhile, we pass along holiday greetings and hope everyone has a chance to catch up on some fun things and enjoy life. See you soon… Cephalon Names Kevin Buchi As CEO (statement) Lundbeck Alcoholism Pill May Be A Goldmine (Bloomberg News) Novartis To Build Vaccine Plant In North Carolina (Raleigh News & Observer) FDA Reviews Safety Of Human Growth Hormone Drugs (Reuters) Pfizer And Bristol Bloodthiners Beats Sanofi Drug In Study (Bloomberg News) Massachusetts Award... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4285353 Thu, 23 Dec 2010 12:54:53 +0100 4285353 http://www.medworm.com/index.php?rid=4281268&cid=t_100786_83_f&fid=34856&url=http%3A%2F%2Finsidesurgery.com%2F2010%2F12%2Ffda-approves-gardasil-anal-cancer%2F The United States Food and Drug Administration has expanded the recommended uses of Gardasil to include the prevention of anal cancer. The drug, which is also approved for use against anal warts, acts against the human papillovirus (HPV) microbe which is thought to be an etiological factor in many anal cancers. The FDA’s Dr. Karen Midthun comments. (Source: Inside Surgery) Inside Surgery blogs http://www.medworm.com/rss/comments.php?id=4281268 Thu, 23 Dec 2010 02:25:01 +0100 4281268 http://www.medworm.com/index.php?rid=4179525&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FXGVfJpCTsxU%2F Hello, everyone. Another shiny day is unfolding here at the Pharmalot corporate campus where, as usual, we are hustling short people off to the local school house and brewing the mandatory cup of stimulation. A truly busy day, however, lies in store. You know that feeling, yes? So please join us as we prepare for another round of meetings and deadlines. And of course, here are some tidbits to get us going. Have a good one and see you soon… Pfizer And Cipla May Ink Global Supply Deal (The Times of India) Genzyme Sells Diagnostic Unit To Sekisui Chemical (Reuters) India Tightens Clinical Trial Guidelines (Outsourcing Pharma) Israeli Biotechs Flock To Ohio For Funds And Experts (Bloomberg News) FDA Panel Backs Merck’s Gardasil To Thwart Anal Cancer (Associated Press) Montana Gover... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4179525 Thu, 18 Nov 2010 12:55:37 +0100 4179525 http://www.medworm.com/index.php?rid=4155401&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fain6fpEbfME%2F The reasons are likely numerous, but only 27.3 percent of eligible teenage girls and young women chose to begin the three-dose series of an HPV vaccine. And of these, 39.1 percent completed just one dose, 30.1 percent got two doses and 30.7 percent finished the series, according to research being presented this week at the American Association of Cancer Research annual meeting. The data comes from a review of medical records of 9,658 girls and women between the ages of 9 and 26 who were seen at the University of Maryland Medical Center between August 2006 and August 2010, HealthDay writes. The abstract also revealed that blacks were less likely than whites to get all three doses, and women aged 18 through 26 were less likely than younger girls to complete the series. Last summer, a US Cen... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4155401 Thu, 11 Nov 2010 13:36:09 +0100 4155401 http://www.medworm.com/index.php?rid=4125008&cid=t_100786_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fvaccines-top-10-reasons-to-get-your-shots%2F2010.11.01 Vaccines have saved more lives than any other medical intervention in history. They are incredibly safe and effective and are well-tolerated by most people. In the US, the Centers For Disease Control and Prevention (CDC) carefully reviews all reports of adverse reactions that could be associated with vaccines. Over decades of review, they have found that the rate of potential severe reactions is so low that they cannot even calculate a risk. There are many vaccines available for babies, children, and adults. Please check these vaccine schedules to make sure that you and your family are fully protected from vaccine-preventable diseases. (Or you can ask your doctor/nurse to review your vaccine needs with you in person.) Vaccines for ages 0-6 click here. Vaccines for ages 7-18 click here. Vac... Better Health blogs http://www.medworm.com/rss/comments.php?id=4125008 Mon, 01 Nov 2010 17:00:32 +0100 4125008 http://www.medworm.com/index.php?rid=4106059&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FSQVMR3QVZ2E%2F Taking a direct approach with the FDA is all the rage these days. For instance, aggrieved investors recently created an online petition to implore the FDA to investigate staffers for their input into a recent panel meeting for the Arena Pharmaceutical diet pill (see this). And now several parents, who formed a non-profit to protest widespread use of Merck’s Gardasil vaccine for HPV, have written the agency to demand that approval be rescinded. In its letter, SANE Vax argues that the FDA permitted Merck to use “an inappropriate primary endpoint and unreliable HPV genotyping methods” evaluating efficacy. You can read the letter here to learn more, but basically the group maintains that less serious cervical lesions were permitted as an endpoint and they cite National Cancer... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4106059 Mon, 25 Oct 2010 16:05:35 +0100 4106059 http://www.medworm.com/index.php?rid=4031246&cid=t_100786_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F10%2F05%2Fhope-on-the-horizon%2F First they ignore you, then they laugh at you, then they fight you, then you win. A good person will resist an evil system with his whole soul. Disobedience of the laws of an evil state is therefore a duty. Mohandas Karamchand Gandhi (1869 – 1948) If ever there were a time that elucidates the counsel of history’s greatest nonviolent social protester Mahatma Gandhi, it is now. Perhaps nothing exemplifies Gandhi’s admonitions better than the healthcare issues we find ourselves embroiled in and embattled with: loss of self determination because of pharmaceutical corporate influence and possible greed, yoked together with governmental agency inadequacy, probable conspiracies, and Congressional disregard. All that leads to healthcare consumers paying huge bills and suffering m... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=4031246 Tue, 05 Oct 2010 13:12:49 +0100 4031246 http://www.medworm.com/index.php?rid=3921077&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FIdVyE8QL1Fg%2F Hello, everyone. Nice to see you again. A chipper morning here on the Pharmalot corporate campus, where our sponsor - me - would like to remind you about an upcoming webinar with former US Attorney Michael Loucks, who will chat about avoiding litigation over promoting medicines (please click here). Meanwhile, the time has come again to reach for that cup of stimulation and draw back the curtains to let the sunshine in. Hope your day goes well… AstraZeneca Fails To Win FDA OK For Respiratory Drug (Associated Press) Robo-Tripping May Lead To New Controls On Cough Meds (Bloomberg News) Glaxo And Valent Face Delay For Their Epilepsy Drug (Bloomberg News) Meet The Gardasil Girls (The Irish Examiner) Drugmakers Seek Alternatives To Steroids (The New York Times) European Regulators OK Shire... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3921077 Tue, 31 Aug 2010 12:05:01 +0100 3921077 http://www.medworm.com/index.php?rid=3946469&cid=t_100786_87_f&fid=39261&url=http%3A%2F%2Fvactruth.com%2F2010%2F08%2F26%2Findia-halts-vaccine-programme-after-deaths%2F Christina England vactruth.com 08/26/2010 Vaccine programmes grind to a halt in India once more, when four children died after they received the measles vaccination in Lucknow. The four children were reported to have fainted soon after they were vaccinated and witnesses reported seeing the children’s eyes roll back as they began to have seizures. All of the children were under the age of two years of age, with the youngest being just six months. Sadly the children died before medical aid workers could reach them. As news of the deaths spread, immunization drives in 41 villages have been halted until further investigations have taken place. // The Indian Express stated in their article “4 children die within minutes of vaccination” that- “The immunisation programm... vactruth.com blogs http://www.medworm.com/rss/comments.php?id=3946469 Thu, 26 Aug 2010 10:42:10 +0100 3946469 http://www.medworm.com/index.php?rid=3899637&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fk0EBwlUTXr4%2F There may still be controversy over human papillomavirus vaccines - notably, Merck’s Gardasil - but teenage vaccination rates are creeping up, according to a US Centers for Disease Control and Prevention survey of more than 20,000 teens between the ages of 13 and 17 (see here). The vaccines, which include GlaxoSmithKline’s Cervarix, were endorsed by public health officials to thwart cervical cancer. Specifically, the survey found increases in the percentage of teens who received vaccines routinely recommended for 11 and 12-year-olds. Among teenage girls who received at least one of three necessary doses of an HPV vaccine, coverage increased 7 percent to about 44 percent. But for girls who received all three doses, coverage was only 27 percent, which amounted to a 9 percent incr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3899637 Tue, 24 Aug 2010 12:00:24 +0100 3899637 http://www.medworm.com/index.php?rid=3845284&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FFNl5DmcDSBc%2F For the first time in three years, Merck can now say that all of its pediatric vaccines are again available. The disclosure, which was made on its supply status web page on Aug. 2, follows a series of components shortages and manufacturing gaffes that continue to leave some adult vaccines unavailable. The drugmaker is once again shipping Comvax, a combination vaccine that is used to ward off meningitis and hepatitis B. Earlier this year, Merck restored supplies of PedvaxHIB for meningitis; ProQuad, which vaccinates against measles, mumps, rubella and chickenpox; and the pediatric formulation of hepatitis B vaccine Recombivax HB. However, Merck continues to have difficulties with some of its adult vaccines. As previously noted, the adult version of Recombivax will not be available at all th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3845284 Mon, 09 Aug 2010 11:59:23 +0100 3845284 http://www.medworm.com/index.php?rid=3780330&cid=t_100786_87_f&fid=36050&url=http%3A%2F%2Fblisstree.com%2Flive%2Fhpv-may-increase-skin-cancer-risk%2F Human papillomavirus (HPV), commonly linked with cervical, vaginal, and throat cancers, may be associated with yet another serious health risk: skin cancer. A new study led by Dr. Margaret Karagas of Dartmouth Medical School in New Hampshire found that subjects with HPV had a higher risk of developing squamous cell carcinoma, the second most common type of skin cancer. The study compared HPV antibody levels in 663 adults with squamous cell carcinoma, 898 people with basal cell carcinoma, and 805 healthy control patients. They found that testing positive for two or three types of HPV translated into a 44% higher risk for squamous cell carcinoma, and having four to eight types meant a 51% higher risk. Having over eight types boosted the risk to over 71%. Testing positive for two or three typ... Breastfeeding 1-2-3 blogs http://www.medworm.com/rss/comments.php?id=3780330 Thu, 22 Jul 2010 16:07:49 +0100 3780330 http://www.medworm.com/index.php?rid=3737296&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Ffddq69mEzdI%2F As Merck looks to extend the market for its Gardasil HPV vaccine to older women (back story), a new study finds the human papillomavirus shows up in young children whose airways may become infected while in the womb or during childbirth. As a result, children can develop wart-like lesions of the nose, pharynx, trachea and bronchi, a problem known as juvenile onset recurrent respiratory papillomatosis, or JoRRP, which can interfere with breathing and require surgical removal. The study, which was published online in The Laryngoscope (subscription required), found that between 1994 and 2007, the overall incidence rate of JoRRP in children aged 14 and younger was only 0.24 cases per 100,000, or 243 reported cases (the prevalence rate was 1.11 per 100,000). And these required 3,021 surgical pr... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3737296 Thu, 08 Jul 2010 12:20:45 +0100 3737296 http://www.medworm.com/index.php?rid=3730095&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FyREbKSL71QY%2F A watchdog group has asked the Federal Trade Commission to investigate contract pricing arrangements that Merck and Sanofi-Pasteur offer physician practices. In a letter to the FTC, the Citizens for Responsibility and Ethics in Washington allege the vaccine makers offer docs significant discounts, but only after signing contracts prohibiting them from purchase vaccines made by rivals. To make its case, CREW cites memos and emails written by four different physician groups in which its doctors are reminded to purchase only vaccines from Sanofi-Pasteur or Merck if they want to obtain the best prices. The vaccines include Merck’s Gardasil for HPV, Rotateq for rotavirus, and Recombivax for hepatitis B, while the Sanofi vaccines include several products, notably Menactra for meningitis. C... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3730095 Tue, 06 Jul 2010 15:25:47 +0100 3730095 http://www.medworm.com/index.php?rid=3672038&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FODzQwVUybYI%2F Yet another setback for Merck, at least for now. The FDA has postponed a decision to broaden usage of its Gardasil HPV vaccine to women between the ages of 27 and 45. Earlier this year, the drugmaker submitted new data to the FDA and had hoped to hear by the end of June, but a Merck spokeswoman tells us the agency will now respond by the end of 2010. The drugmaker has been repeatedly frustrated in its quest to widen the market for Gardasil. The vaccine is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. Gardasil is also approved to prevent genital warts in males of the same age. Exactly two years ago, the FDA bounced its request to treat older women and early last year, the FDA again withheld a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3672038 Wed, 16 Jun 2010 20:17:54 +0100 3672038 http://www.medworm.com/index.php?rid=3621949&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FUaS4XdiMCE0%2F Only 34 percent of teenage girls ages 13 to 17 received Merck’s Gardasil human papillomavirus vaccine, which public health officials endorsed to help prevent cervical cancer. Although the vaccination rate remains low, the results actually suggest an increase from earlier studies showing only about 25 percent of teenage girls were vaccinated, according to one of the study’s co-authors. “The good news is that the vaccination rate is increasing,” study co-author Sandi Pruitt of the University of Washington School of Medicine, tells us. “The bad news is this is just the first dose of a three-dose vaccine.” Although the study did not examine the reasons for the persistently low vaccination rates, she speculated that cost, awareness and social conservatism may contribute.... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3621949 Wed, 02 Jun 2010 15:53:05 +0100 3621949 http://www.medworm.com/index.php?rid=3618092&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FVcXlT15h6x4%2F Welcome back. We hope you had a nice weekend. It was a long one here in the states. Now, of course, the routine has returned and that means a to-do list complete with meetings and deadlines. So grab that cup of stimulation and get ready for another day. To help you along, here are a few items of interest. Have a good one and stay in touch… Glaxo Settles More Avandia Lawsuits (Reuters) AstraZeneca Gets Complete Response Letter For Axanum (Bloomberg News) EMA Urges Cooperation On Overseas Trials (Outsourcing Pharma) UK’s NICE Rejects Novartis’ Xolair For Children (Reuters) CSL Recalls Flu As Side Effects Rise (Bloomberg News) Singapore Considers Mandatory HPV Vaccination (AsiaOne) Elan Optimistic On Sale Of Drug Delivery Unit (InPharmaTechnologist) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3618092 Tue, 01 Jun 2010 12:03:14 +0100 3618092 http://www.medworm.com/index.php?rid=3408632&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FLiUgnNH3qCw%2F Here’s the connection: the human papillomavirus, which can cause cervical cancer, is also linked to head and neck cancer, including one form called oropharyngeal squamous cell carcinoma, or OSCC, which is spread by oral sex, according to a piece in BMJ. And more cases, particularly in the developing world, are being reported, and so the BMJ researchers suggest wider use of HPV vaccines should be explored - for boys as well as girls. “We need to look at the evidence again to re-evaluate the cost-effectiveness of male children in light of this new and rapidly rising incidence,” Hisham Mehanna of the Institute of Head and Neck Studies at University Hospital Coventry, one of the BMJ researchers, told Reuters. Currently, however, the HPV vaccines - Merck’s Gardasil and G... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3408632 Fri, 26 Mar 2010 12:57:33 +0100 3408632 http://www.medworm.com/index.php?rid=3359214&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FbgsGsCr248w%2F The controversy over the Gardasil vaccine for HPV, which can lead to cervical cancer, has never really gone away and this morning six women will hold a teleconference with several FDA officials to discuss numerous adverse events they say they have collected from various countries in hopes of convincing the agency to take a tougher look at the Merck product. They call themsevles the “Little Women,” and they say they’ve spent the past three years documenting Gardasil. They also run a web site called TruthAboutGardasil, which displays pictures of young women who, their families claim, were harmed by the vaccine. For its part, Merck has always stood by the safety of Gardasil and last year, both the FDA and the CDC reaffirmed the vaccine’s safety and effectiveness (see ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3359214 Fri, 12 Mar 2010 13:21:55 +0100 3359214 http://www.medworm.com/index.php?rid=3302636&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FG4qZxWrBJDg%2F Hello, everyone. Nice to see you again. A dreary week here at the Pharmalot corporate campus, where assorted short people are battling head colds and moving about at a sluggish pace. We urge them to persevere but, alas, they are too young for the magic cup of stimulation (coffee, for those of you whose imaginations are too vivid). Meanwhile, we now turn our attention to the day ahead, as should you. So dig in and have a good one… Roche’s Xeloda Cancer Drug Gets New EU OK (Reuters) Canada Approves Gardasil For Warts In Boys (Edmonton Journal) Basilea And Astellas Sign Licensing Deal (Reuters) FDA Warns Lilly Over Violations At Plant (FDA warning letter) FDA Warns About HIV Drug Combo Risk (Associated Press) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3302636 Wed, 24 Feb 2010 12:44:03 +0100 3302636 http://www.medworm.com/index.php?rid=3288018&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FGM7yGlc5NZ4%2F A New York State bill that would allow healthcare practitioners to vaccinate children (not just girls) under 18 against HPV without parental consent appears to be on hold for now. The language in a Senate bill is being clarified and no other legislative action is currently under way, according to an email from New York State Senator Eric Schneiderman to Diane Harper, who was a researcher for Merck’s Gardasil vaccine and has called for more complete warnings for parents (some background). The disclosure concerning the bill comes after some hoopla over the initiative, which would dovetail with an assembly bill requiring vaccinations before children would be allowed to attend school. The overall effort drew some protest in light of the ongoing debate, in some quarters, over the safety ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3288018 Fri, 19 Feb 2010 16:03:36 +0100 3288018 http://www.medworm.com/index.php?rid=3280190&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZ1eU3oGqWAs%2F Gardasil protected most women from cervical cancer and homosexual men from anal cancer, according to new studies from Merck. In about 3,800 women ages 24 to 45 years old, three shots prevented precancerous lesions on the cervix and genital warts in 89 percent compared to placebo, the Associated Press writes. Gardasil, you may recall, is approved to prevent cervical cancer and genital warts in girls and women aged 9 to 26, and for preventing genital warts in boys and men aged 9 to 26. But Merck has been frusrated trying to win FDA approval to widen the market for its HPV vaccine. In June 2008, the agency bounced its request to treat women aged 27 to 45, which contributed to a slowdown in sales (background here). Early last year, the FDA again withheld approval and asked Merck to submit data... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3280190 Wed, 17 Feb 2010 13:22:10 +0100 3280190 http://www.medworm.com/index.php?rid=3197885&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F_5l-Xitz6Rs%2F For those wondering about the reactions that some consumers have to DTC television ads, some decide to search for more info online. So which ads are prompting the most activity and which product sites are visited? NuvaRing and Latisse had the highest percentage of overall product website traffic driven by their DTC TV ads, according to Manhattan Research. NuvaRing, which is a contraceptive made by Merck, jumped five spots from last year to take the top ranking. And as you can see, Allergan’s new eyelash enhancement treatment, Latisse, grabbed the No. 2 spot. Unfortunately, there was no corresponding info to contrast the amount of ad spending with web traffic. In any event, here is the list of the ten brands for which DTC ads drove the most web traffic… 1. NuvaRing 2. Latisse ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3197885 Fri, 22 Jan 2010 13:19:09 +0100 3197885 http://www.medworm.com/index.php?rid=3176121&cid=t_100786_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FePharmaSummit%2F%7E3%2F1fcV9LKHq8w%2Fas-seen-on-tv-pharmas-top-websites.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=3176121 Thu, 14 Jan 2010 19:23:00 +0100 3176121 http://www.medworm.com/index.php?rid=3172200&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FdhxPlWdO1r8%2F The Gardasil grope continues. Merck gave the FDA new data to win approval to market its HPV vaccine to women between the ages of 27 and 45. Gardasil is already approved to protect against some strains of the human papillomavirus, which can lead to cervical cancer, in girls and women ages 9 to 26. The vaccine is also approved to prevent genital warts in males of the same age. Merck has been trying for some time to win FDA approval to market Gardasil to more women, but has so far been frustrated. In June 2008, the agency bounced its request to treat women between ages of 27 and 45, which contributed to a slowdown in sales (background here). Early last year, the FDA again withheld approval and asked Merck to submit data when a 48-month study on a test group has been completed. Approved in 200... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3172200 Thu, 14 Jan 2010 12:53:31 +0100 3172200 http://www.medworm.com/index.php?rid=3123416&cid=t_100786_111_f&fid=36048&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FAHeartyLife%2F%7E3%2FbDAn9q7HkQY%2F It’s easy to remember the most recent stories or advances in health and medicine – but what about what else has happened since the hysteria of Y2K? Whether it’s Terri Shiavo in 2005 or the H1N1 virus in 2009, it’s impossible to list a “top 10″ list with everyone in agreement. However, the idea of the top 10 lists is to help us remember, to think about what’s happened, and maybe to continue making a difference. Here is a list of top 10 health stories that did get a lot of press: 2000: The Human Genome Project. Scientists had been working on mapping out the genes of humans and finally, in June 2000, they were able to present their draft of the human genome. 2001: Anthrax scare. According to CNN.com news people, the anthrax scare made it to the top 10... A Hearty Life blogs http://www.medworm.com/rss/comments.php?id=3123416 Sat, 26 Dec 2009 16:57:44 +0100 3123416 http://www.medworm.com/index.php?rid=3111688&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FnmCGn24Ph4c%2F Julie Gerberding, who until this year was the director of the US Centers for Disease Control and Prevention, was named president of Merck’s vaccine division. Gerberding, who led the CDC from 2002 to 2009, stepped down when President Barack Obama took office this year (see statement). The move comes a few months after Margie McGlynn, a former sales and marketing exec, retired as Merck’s vaccines chief. The big drugmaker markets vaccines for several childhood ailments, as well as shingles and Gardasil, which combats the human papillomavirus, or HPV. Last year, however, vaccine sales fell 2 percent amid manufacturing woes and controversy over Gardasil safety and marketing. Gerberding had led the agency during a series of crises - the investigation into anthrax attacks that killed ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3111688 Mon, 21 Dec 2009 17:35:15 +0100 3111688 http://www.medworm.com/index.php?rid=2963331&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FMKV_4dafnTc%2F Two commercials for Flomax topped the ranking of the most recalled drug and vaccine ads during the 2008-09 TV season, according to a Nielsen analysis. The Boehringer-Ingelheim drug, which treats male urinary symptoms due to BPH, ran two ads that were recalled at a rate that was 42 percent greater than the average ad based on all newly-launched prescription drug ads. The latest installments of the Flomax DTC campaign feature men at a baseball game and men playing on a golf course. Lilly’s Cialis and Merck’s Gardasil tied for second on the list with 32 percent greater recall than the average drug ad launched last season. The Cialis ad was an extension of its “What are you waiting for?” campaign and featured outdoor tubs filled with various couples (you know the imagery by now... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2963331 Thu, 05 Nov 2009 12:53:45 +0100 2963331 http://www.medworm.com/index.php?rid=2916440&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvgCad28JxBA%2F Hello, everyone. Nice to see you again. Busy week, yes? The earnings season can be overwhelming at times, but also quite interesting. Today is no exception. And so, we must get started. First, however, we must bundle one of the short people off to the school house. So please enjoy these as you start your own day. Hope it’s a good one… Schering-Plough Cholesterol Drugs Slump, Profit Falls (Reuters) Amgen Discloses More Delays For Denosumab (Bloomberg News) Bristol-Myers Sales Rise, But Profits Fall (Associated Press) Novartis Lifts Its Sales Forecast (Bloomberg News) Merck Profits Beats Forecasts (Reuters) ACIP Recommends Gardasil For Boys (NY Times) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2916440 Thu, 22 Oct 2009 11:20:48 +0100 2916440 http://www.medworm.com/index.php?rid=2916433&cid=t_100786_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F10%2Fattention-neurologists-look-for.html Oct. 16, 2009 (Baltimore) -- Researchers believe that there may be a link between a vaccine against cervical cancer and a rapidly progressive, fatal disease in two young women.Both the timing of the symptoms and autopsy results “suggest a link between” the Merck Gardasil vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, says Catherine Lomen-Hoerth, MD, director of the ALS Center at University of California San Francisco Medical Center.With only two confirmed cases, “we don’t know for sure if it’s coincidence or if they’re connected [to the vaccine],” she tells WebMD. “We hope that by raising awareness, we will become aware of any other cases."More at WebMDPresumably GSK will be looking at Cervarix as well.Hat tip: Helen ... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2916433 Thu, 22 Oct 2009 08:48:00 +0100 2916433 http://www.medworm.com/index.php?rid=2905111&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FKJA-jZTfpig%2F This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money,” researcher Jane Kim, an assistant professor at the Harvard School of Public Health told HealthDay. And this was released just as the CDC’s Advisory Committee on Immunization Practices this week reviews the cost-effectiveness of male vaccination (see agenda). (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2905111 Mon, 19 Oct 2009 12:17:39 +0100 2905111 http://www.medworm.com/index.php?rid=2899190&cid=t_100786_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2009%2F10%2Ffound-in-mercks-marketing-department.html Picture credit!Matt Herper has the story! (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=2899190 Thu, 15 Oct 2009 16:59:00 +0100 2899190 http://www.medworm.com/index.php?rid=2741329&cid=t_100786_86_f&fid=34445&url=http%3A%2F%2Fwomenshealthnews.wordpress.com%2F2009%2F08%2F27%2Fat-our-bodies-our-blog-kennedy-pregnancy-loss-infertility-and-gardasil%2F Yesterday at Our Bodies Our Blog, Christine wrote about the passing of Sen. Edward Kennedy, and OBOS Executive Director Judy Norsigian shared her thoughts on the man (both with an emphasis on healthcare). Christine also alerted us to nine stories on infertility and pregnancy loss from readers of Mrs. Spock now published at Our Bodies Ourselves. Finally, I wrote about the marketing of Gardasil, using information from a piece in a recent issue of JAMA. I have to say, as much as I thought mandates (with generous opt-out provisions) were okay for this one b/c it would get the vaccine paid for for the underserved women who needed it, I’m more that a little perturbed about Merck’s apparent tactic of enlisting (through financing) professional medical organizations to speak positively... Women's Health News blogs http://www.medworm.com/rss/comments.php?id=2741329 Thu, 27 Aug 2009 14:19:11 +0100 2741329 http://www.medworm.com/index.php?rid=2513152&cid=t_100786_150_f&fid=38374&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FEPharmaSummit%2F%7E3%2FpQvanQjBFDU%2Fcompanies-that-have-jumped-into-online.html (Source: ePharma Summit) ePharma Summit blogs http://www.medworm.com/rss/comments.php?id=2513152 Wed, 17 Jun 2009 15:19:00 +0100 2513152 http://www.medworm.com/index.php?rid=2354101&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2009%2F04%2Fgardasil-sales-one-less-out-of-three.html Merck's cervical cancer vaccine, GARDASIL, posted total sales as recorded by Merck of $262 million for the first quarter of 2009, a 33 percent decline from the same quarter in 2008 (see "Merck Worldwide Sales Decrease 8%"). This continues the same decline in sales reported in October 2008 for the July/August 2008 v 2007 period reported by IMS (see here). Thus, this current decline cannot be considered seasonal and may not even be related to the bad economy.It is speculated that as more girls get the shot, its remaining market declines. Merck must target increasingly larger populations (see "Merck's Goal: 'One Less' Gardasil Marketing Problem").Recently, Gardasil ads re-appeared in TV, which is obviously an attempt to maintain sales or prevent further decreases.Will this marketing succeed?T... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=2354101 Tue, 21 Apr 2009 11:54:00 +0100 2354101 http://www.medworm.com/index.php?rid=2096271&cid=t_100786_160_f&fid=38218&url=http%3A%2F%2Fwaronwarts.com%2F2009%2F01%2Fthe-hpv-vaccine-video%2F (Source: War On Warts) War On Warts blogs http://www.medworm.com/rss/comments.php?id=2096271 Mon, 12 Jan 2009 00:39:35 +0100 2096271 http://www.medworm.com/index.php?rid=2013832&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F474665875%2F The drugmaker released its so-called guidance fo 2009 and forecasts that earnings and revenue will wind up below Wall Street forecasts. A key reason for the declining profit are lower sales of its Vytorin and Zetia cholesterol pills, which are sold as part of a joint venture with Schering-Plough. In a statement, Merck ceo Dick Clark blamed “a volatile global economy,” currency exchange rates and “continued challenges” for key products. The drugmaker is already in the process of eliminating 7,200 jobs and closing plants as generic competition to big-selling meds looms (back story), undermining a heralded turnaround (see Forbes). As for specific products, revenues from the Gardasil HPV vaccine are expected to be flat next year, as Merck continues to struggle with questions over safet... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2013832 Thu, 04 Dec 2008 13:33:36 +0100 2013832 http://www.medworm.com/index.php?rid=2011566&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F473498128%2F ‘Tis the middle of the week and that can mean only one thing - the need to dig out from under meetings, deadlines and projects. To help you cope, we have unearthed a few items of interest. Hope your day goes well, no matter what… Merck Shifts Seattle Chief To Boston Lab (Bio-ITWorld) Gardasil Allergic Reactions Are Uncommon: Study (Yahoo/Reuters) Glaxo To Cut 200 Jobs At UK Plant (BBC) Asthma Sufferers Concerned Over New Inhalers (Arizona Republic) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2011566 Wed, 03 Dec 2008 11:19:30 +0100 2011566 http://www.medworm.com/index.php?rid=2006394&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F471402611%2F Unlike many other European countries, Ireland has chosen not to launch a program to vaccine young girls and women, prompting Glaxo, which sells Cervarix, and Sanofi-Pasteur, which markets Merck’s Gardasil in Europe, to fly in experts to talk to consultants and public health care professionals about the benefits of their HPV vaccines, according to The Times of London. Ireland’s health department cited administrative costs as its reason for not proceeding. A spokeswoman for health minister Mary Harney tells the Times she is already convinced of the important role a vaccine program would play “as part of a cohesive response” to cervical cancer, but the “decision not to proceed at this point is not based on the scientific evidence, but is related to the need to prioritize... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=2006394 Mon, 01 Dec 2008 15:26:07 +0100 2006394 http://www.medworm.com/index.php?rid=1955499&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F449932676%2F A trio of academics is joining the debate over the notion requiring girls to be vaccinated with Merck’s Gardasil is not a good idea. And in a recent issue of the Journal of Law, Medicine & Ethics, Gail Javitt of Johns Hopkins’s Berman Institute of Bioethics, Deena Berkowitz of George Washington University School of Medicine and Lawrence Gostin of Georgetown University Law Center they offer five reasons.. The long-term safety and effectiveness is unknown; historical justifications for mandated vaccination have not been met; in the absence of historical justification, the government risks public backlash by mandating vaccination; mandatory vaccination for girls - and not boys - may violate constitutional principles of equality and due process; and there are unresolved economic c... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1955499 Tue, 11 Nov 2008 20:33:15 +0100 1955499 http://www.medworm.com/index.php?rid=1915071&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F433526699%2F Never mind that a recent study found its HPV vaccine isn’t cost effective for women over 18 years old and that the FDA earlier this year rejected Gardasil for women between the ages of 27 and 45 (back story), Merck continues to push for widespread vaccination for adult women. Over the weekend, researchers told the American Society for Microbiology and the Infectious Diseases Society of America that an aggressive strategy of vaccinating older women could cripple cervical cancer, which is traced to HPV. Using a mathematical model, they showed that vaccinating women in the US by ages 12 through 45 against HPV could reduce cervical cancer cases by up to 55 percent for 45-year-old women, Reuters writes. The Reuters story, by the way, failed to note the speaker, Warner Huh of the Universi... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1915071 Mon, 27 Oct 2008 12:35:49 +0100 1915071 http://www.medworm.com/index.php?rid=1906166&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F429797140%2F Amid ongoing controversy over the safety and effectiveness of the HPV vaccine, the Centers for Disease Control and Prevention yesterday declared that Gardasil is not likely the cause of numerous adverse events. “Based on all of the information we have today, the CDC and FDA have determined that Gardasil is safe to use and effective in preventing 4 types of HPV,” the CDC says. The decision came after both adverse event reports and data from the first post-marketing safety study was presented to a CDC panel. The study looked at 375,000 doses of the vaccine from August 20, 2006, the year Gardasil was approved, to July 20, 2008, in girls and women ages 9 to 26 (here is the statement). As of August 31, there were 10,326 adverse events reported in the US, of which 94 percent were con... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1906166 Thu, 23 Oct 2008 16:47:50 +0100 1906166 http://www.medworm.com/index.php?rid=1891986&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2008%2F10%2Fmercks-goal-one-less-gardasil-marketing.html Merck is trying to market its cervical cancer vaccine Gardasil to women who may not benefit from it after U.S. sales shrank in July and August, according to a Bloomberg article (see "Merck Aims Gardasil to Women Least Likely to Benefit").This is in response to a 33% decline in sales.As pointed out by Jim Edwards over at Bnet "Merck is simply adjusting its strategy to the inevitable grind of numbers: As more girls get the shot, its remaining market declines — and thus Merck must target increasingly marginally profitable populations" (see "At Merck, Desperation Sets in Over Gardasil").Merck clearly is trying to market Gardasil like a drug for long-term medical conditions such as high cholesterol. In fact, according to the Bloomber article:Merck "is counting on Gardasil to help offset decli... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=1891986 Mon, 20 Oct 2008 13:50:00 +0100 1891986 http://www.medworm.com/index.php?rid=1892145&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F425618832%2F There are reports from the Netherlands that the Health Inspectorate raided the drugmakers’ offices late last week as part of an investigation into the Health Council, an independent body that advises the Dutch government and parliament on public health issues, and recently recommended that girls should be vaccinated against HPV (look here). In Europe, Sanofi-Aventis markets Gardasil, as part of a joint venture with Merck, and Glaxo markets Cervarix, which is not yet approved in the US. Both vaccines are given to treat HPV, which can lead to cervical cancer. The reports say that Health Council members were receiving research funding from the drugmakers at the same time the organization issued its recommendation to Health Minister Ab Klink. The Socialist Party is demanding a parliament... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1892145 Sun, 19 Oct 2008 17:22:45 +0100 1892145 http://www.medworm.com/index.php?rid=1871110&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F416662942%2F Whether this means Merck’s HPV vaccine is making great inroads is unclear, but Gardasil does appear to be on its way to becoming accepted, according to the first federal government study of vaccination rates for the controversial shot. The vaccine protects against strains of the human papillomavirus that cause about 70 percent of cervical cancers. Federal health officials recommend girls get the shots when they are 11 or 12, if possible, before becoming sexually active (here is the info from the CDC’s Morbidity & Mortality Weekly Report). Vaccine proponents had been hoping for higher vaccination rates, contending Gardasil can reduce the nearly 4,000 cervical cancer deaths that occur each year in the US, but many families are cautious about the safety of new vaccines, Patti... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1871110 Fri, 10 Oct 2008 10:05:05 +0100 1871110 http://www.medworm.com/index.php?rid=1856115&cid=t_100786_87_f&fid=35052&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FWomensBioethicsBlog%2F%7E5%2F411974541%2FAAAS-OHRP%2520Sept08.pdf 1. Sex bias in control of cancer pain. Women get less meds, more pain. Sounds like a Raw Deal.2. AAAS comments on human subject protection training.3. Gardasil requirement for immigrants stirs backlash.4. Paxil suit settled by Glaxo for $40M.5. Inspire Pharmaceuticals reaches deal with SEC in investigation related to clinical trial of experimental dry-eye treatment. 6. Chinese parents file tainted milk lawsuit.7. Personalized medicine: new predictive tool can help determine treatment for breast cancer patients (identifies those most at risk of relapse, potentially avoiding chemo).8. Doctors urge the FDA to ban OTC cough and cold medicines for children until they are found safe and effective. Not safe and effective? Perhaps we should resort to that cherry-flavored placebo elixir reported on... Women's Bioethics Blog blogs http://www.medworm.com/rss/comments.php?id=1856115 Sun, 05 Oct 2008 15:52:32 +0100 1856115 http://www.medworm.com/index.php?rid=1798212&cid=t_100786_87_f&fid=35052&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FWomensBioethicsBlog%2F%7E3%2F393285638%2Fmore-evidence-for-mandate-fda-approves.html We and other blogger friends have blogged about Gardasil before here and there -- and in a quick and dirty drive-by post, we thought we'd update you on the latest developments:The AP press reports that federal health officials approved expanding the use of Gardasil, the cervical cancer vaccine, to prevent cancers of the vagina and vulva:"The Food and Drug Administration first approved Gardasil in 2006 for the prevention of cervical cancer in girls and women ages 9 to 26. The vaccine works by protecting against strains of the human papillomavirus, or HPV, that cause about 70 percent of cervical cancers. The HPV virus, transmitted by sexual contact, causes genital warts that sometimes develop into cancer.'There is now strong evidence showing that this vaccine can help prevent vulvar and vagi... Women's Bioethics Blog blogs http://www.medworm.com/rss/comments.php?id=1798212 Mon, 15 Sep 2008 18:06:43 +0100 1798212 http://www.medworm.com/index.php?rid=1790482&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F391130279%2F Perhaps this will fan the controversy over the HPV vaccine still more. In any event, the agency expanded Gardasil’s approved uses to include cancer of the vagina and vulva, but at the same time added new info to the prescribing label about reports of deaths and illnesses. Overall, though, the move gives Merck a boost over Glaxo, whose Cervarix HPV vaccine was delayed last year by the FDA. Gardasil was approved to protect females ages 9 to 26 against four strains of HPV, which can cause up to 70 percent of cervical cancers and 90 percent of genital warts. Docs, however, have needed incentives and Wall Street is disappointed with Gardasil revenue. You may recall that a recent study found Gardasil makes economic sense for preteens because they are less likely to have the sexually transm... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1790482 Sat, 13 Sep 2008 01:14:10 +0100 1790482 http://www.medworm.com/index.php?rid=1786181&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F388696033%2F There are at least four - count ‘em, four - issues that are plaguing Merck and prompting Sanford Bernstein analyst Tim Anderson to downgrade the shares. In an investor note this morning, he writes the stock has already hit his $36 price target and has little upside. Why? Let’s see… Reasons To Be Doubtful, Number One: The Singular allergy med. Prescription trends are lagging, there is an ongoing FDA safety review that could report out at year’s end (look here), and the potential that Teva does an ‘at risk launch of a generic next year; Reasons To Be Doubtful, Number Two: Sales trends for the Gardasil HPV vaccine have been weak for the last few quarters in the three territories reported by Merck (background here and here. Reasons To Be Doubtful, Number Three: Th... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1786181 Wed, 10 Sep 2008 14:06:03 +0100 1786181 http://www.medworm.com/index.php?rid=1760167&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F381421958%2F A new study looking at young women in Australia who were vaccinated with Merck’s HPV vaccine shows they were five to 20 times more likely to suffer from anaphylaxis than girls in comparable school-based programs, although the study authors, nonetheless, conclude the vaccine is still “remarkably safe.” The study, published in the Canadian Medical Association Journal, looked at 114,000 women. They found 12 suspected cases of anaphylaxis, and confirmed eight in a 2007 vaccination program. Symptoms included difficulty in breathing, nausea and rashes, PharmaTimes writes. (We will provide a link to the study as soon as it becomes available). The reasons for an increased rate of anaphylaxis may include possible allergic reaction to the vaccine components or enhanced adverse even... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1760167 Tue, 02 Sep 2008 14:47:54 +0100 1760167 http://www.medworm.com/index.php?rid=1750107&cid=t_100786_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F09%2Fcervix-wars-contd-score-one-for.html The pink leaflets are ready, the posters are poised to go up and the advertising slots have been booked both on kids and primetime TV and radio.Tomorrow marks the start of a new academic year. It is also the launch date of a campaign which heralds the introduction of the biggest mass vaccination programme for more than a decade.By the end of September, there will hardly be a Year Eight girl (aged 12-13) in the UK who doesn't know that, barring an opt-out, she is shortly to receive three injections of the drug Cervarix, which will offer her 70 per cent protection against cervical cancer.More (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1750107 Tue, 02 Sep 2008 07:46:00 +0100 1750107 http://www.medworm.com/index.php?rid=1739488&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F377367238%2F First, there was the Gardasil beach towel, an attractive terry velour model that advertised to beachgoers that you’re free of a sexually transmitted disease. A nifty way to tout the advantages of the HPV vaccine. Now, Merck is trying a new way to grab the attention of teenagers and younger adult women with a specially created line of Gardasil jewelry. As CNBC’s Mike Huckman notes, you can pay $32 for any of four “limited edition” bangles designed by Carolyn Rafaelian, a designer with Alex and Ani. The proceeds will go to the Prevent Cancer Foundation. The Charm4Life campaign is designed to raise awareness of cervical cancer. Gardasil, to be technical about all this, is supposed to thwart the most significant strains of HPV, or human papillomavirus, which can lead t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1739488 Thu, 28 Aug 2008 18:47:12 +0100 1739488 http://www.medworm.com/index.php?rid=1734255&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F375230213%2F The sites that feature diabetes meds top the list, with Merck’s Januvia garnering the No. 1 ranking and Takeda Pharmaceutical’s Actos finishing second, according to Manhattan Research, which says it conducted an online survey in this year’s second quarter of 1,681 docs practicing in the US. Interestingly, the research firm says that more docs are visiting sites for controversial drugs - Pfizer’s Chantix smoking-cessation pill and Merck’s Gardasil vaccine for HPV. Actos, by the way, crashed the list for the first time, perhaps reflecting the problems with a rival diabetes pill, Glaxo’s Avandia. 1. Januvia 2. Actos 3. Chantix 4. Gardasil 5. Actonel 6. Vytorin 7. Amitiza 8. Byet... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1734255 Tue, 26 Aug 2008 12:44:29 +0100 1734255 http://www.medworm.com/index.php?rid=1730772&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F374190073%2F Welcome to the working week. Although this week may prove to be a bit slow here and there. It is vacation time, after all. Nonetheless, we are poking around for interesting items. So settle in and catch up with the latest… Study Finds Ideas About Sex Don’t Bar Gardasil Use (The Houston Chronicle) Pfizer Drops NicOx Glaucoma Drug For Asian Study (Yahoo/Finance) India To Review Daiichi Bid For Ranbaxy (Bloomberg News) Bristol-Myers Employees Charged With Forging Tuition Reimbursement (MyCentralNewJersey.com) Indonesian Drug Prices Soar On Raw Materials (The Jakarta Post) (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1730772 Mon, 25 Aug 2008 11:26:24 +0100 1730772 http://www.medworm.com/index.php?rid=1729474&cid=t_100786_105_f&fid=35048&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FMedicineAndMan%2F%7E3%2F373063230%2F More proof that we need extended studies before blanket recommendations are made for targeting the entire population rather than “high risk” (in this case most likely to benefit) group. A new study suggests that giving Merck & Co.’s cervical-cancer vaccine Gardasil to women through their mid-20s may not be worth the price, despite U.S. recommendations that this age group receive the costly shot. The study, published online Wednesday by The New England Journal of Medicine, comes as Merck already is having difficulty persuading college-age and older women to get the vaccine, which was introduced in 2006 and costs about $360 for a three-dose regimen. This has contributed to a slowdown in Gardasil sales, casting a cloud on Merck’s financial outlook. Study Questions ... Medicine and Man blogs http://www.medworm.com/rss/comments.php?id=1729474 Sun, 24 Aug 2008 00:15:54 +0100 1729474 http://www.medworm.com/index.php?rid=1720549&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F370874413%2F That’s the conclusion of a new study that is going to make life much harder for Merck to wring needed sales out of its controversial HPV vaccine. The study, which appears in the New England Journal of Medicine, comes as the drugmaker is already struggling to convince college-age and older women to get the vaccine, which costs about $360 for a three-dose regimen. The vaccine, which was approved for girls and young women ages 9 to 26, makes economic sense for preteens because they are less likely to have the sexually transmitted virus that causes cervical cancer, according to the study. But the cost and benefit depends on how long Gardasil’s protection will last. Here is the study, although Merck contends the vaccine is cost effective for women through age 24. The analysis predic... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1720549 Thu, 21 Aug 2008 12:05:08 +0100 1720549 http://www.medworm.com/index.php?rid=1717570&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F369246246%2F As Gardasil revenue disappoints, the drugmaker is scrambling for ways to boost (pun intended) sales of the controversial HPV vaccine. So Merck is now promising docs a free replacement dosage if an insurer refuses coverage, according to Maggie McGlynn, who heads Merck’s vaccines business and mentioned the effort during a conference call with institutional investors arranged by Deutsche Bank today. Unfortunately for Merck, too many docs have been asking their patients to first check with their health insurers to see if the shots would be covered. As you can imagine, this led to fewer shots. So McGlynn told the crowd that by having the replacement program, “they will convert to same-day vaccination.” However, this only applies to women between 19 and 26 years old, since younger... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1717570 Wed, 20 Aug 2008 10:18:58 +0100 1717570 http://www.medworm.com/index.php?rid=1660743&cid=t_100786_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fcervix-wars-contd_28.html The UK Department of Health has announced (PDF) that the human papillomavirus vaccination programme is to be extended to include young women aged 17-18.The decision to use Cervarix® has been criticised but this announcement does start to explain why the programme is using an apparently inferior vaccine.Hat tip: http://www.prescriber.org.uk/ (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1660743 Mon, 28 Jul 2008 14:00:00 +0100 1660743 http://www.medworm.com/index.php?rid=1645927&cid=t_100786_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F07%2Fmerck-gardasil-carry-on-injecting.html A review of health problems reported after women and girls received Merck's Gardasil vaccine shows it remains safe and effective for protecting against a virus that causes cervical cancer, U.S. officials said on Tuesday.More at Reuters (Source: PharmaGossip) PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1645927 Wed, 23 Jul 2008 05:11:00 +0100 1645927 http://www.medworm.com/index.php?rid=1646369&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F342901712%2F In response to ongoing reports of adverse events associated with the HPV vaccine, the FDA and the Centers for Disease Control reviewed side effect reports and today issued a statement indicating Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks. The joint agency review found 94 percent of side effects reported after vaccination were not serious, and these reports included syncope (fainting), pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted. There were also 20 deaths reported, but no common pattern that would suggest these were caused by the vaccine. In cases where autopsy, death certificate and medical records were available, the cause of dea... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1646369 Tue, 22 Jul 2008 20:57:56 +0100 1646369 http://www.medworm.com/index.php?rid=1646372&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F342734559%2F So how do you lose confidence on Wall Street? You can start by acknowledging sluggish sales of key products and withholding earnings guidance for the rest of the year, which is exactly what Merck ceo Dick Clark did yesterday (see the release). So far, Merck shares are down nearly 10 percent today to less than $32, a price not seen in roughly two years. Just months after basking in the warm glow of a $4.85 billion Vioxx settlement - which inspired some investors to hail Merck’s revival - the drugmaker is suffering from difficult sales of two key products - the Singulair asthma med, which has been tied to troubling side effects, and the Gardasil HPV vaccine, which isn’t catching on as planned. And let’s not forget the ongoing woes over Vytorin and Zetia. And so brokerages a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1646372 Tue, 22 Jul 2008 17:19:11 +0100 1646372 http://www.medworm.com/index.php?rid=1594005&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F329047482%2F The drugmaker is one of the stock market’s ugly toads today, thanks to a downgrade by a Wall Street analyst who cites a delay in approval for its Gardasil vaccine for adult women until late next year. And recent sales trends for the HPV vaccine, writes UBS analyst Roopesh Patel, “don’t look encouraging.” To be specific, IMS health data for April and May signal second-quarter Gardasil sales at about $300 million, which means Gardasil revenue would be flat quarter to quarter, and well below his previous estimate of $380 million. Of course, other recent setbacks - the FDA rejection of the Cordaptive cholesterol pill, the protracted slump in Vytorin and Zetia prescriptions and ongoing manufacturing problems affecting supplies of other vaccines - contributed to his downg... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1594005 Mon, 07 Jul 2008 17:31:28 +0100 1594005 http://www.medworm.com/index.php?rid=1556545&cid=t_100786_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F323340828%2F Shocks it’s July and I am working out of the house. I barely made it through June…maybe it is time to get a new computer set? We’ll see… Anyways, here are a few stuff on cancer I might have missed in the recent days: ‘Designer baby’ to be free from breast cancer? Men’s cancer vaccine Accidental fungus leads to promising cancer drug That’s all for now folks..I gotta run! Tags: 'designer baby', accidental cancer drug, breast-cancer, cancer-drug, cancer-vaccine, free of hereditary breast cancer, fungus, Gardasil, men cancer vaccine, MerckShare This (Source: Cancer Commentary) Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=1556545 Mon, 30 Jun 2008 16:00:43 +0100 1556545 http://www.medworm.com/index.php?rid=1556509&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F323346511%2F As a result, the Cervarix vaccine may not become available until mid or late 2009, at the earliest. You may recall that, last December, the FDA issued a so-called ‘complete response letter’ for Glaxo’s HPV vaccine, which would compete with Merck’s Gardasil, but it was unclear at the time whether additional clinical trials would be required. Today, the drugmaker says new clinical studies are not expected to be required for approval, but other data will submitted. Specifically, this would be final data from a Phase III pivotal efficacy study, which should be available later this year and submitted to the FDA in the first half of 2009, although exact timing is hard to predict. And with another six-month review period, Cervarix won’t be on the market until late 2009, at t... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1556509 Mon, 30 Jun 2008 13:27:25 +0100 1556509 http://www.medworm.com/index.php?rid=1543343&cid=t_100786_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319775023%2Fgardasil_gets_fda_non-approval_for_expanded_use.html Merck & Co. (NYSE:MRK) announced that the U.S. Food and Drug Administration did not approve the company's application to expand the use of Gardasil to include women between the ages of 27 and 45.Gardasil, a cervical cancer vaccine, was previously approved by the FDA in 2006 for women between the ages of 9 and 27 and the non-acceptance of the expanded use does not affect that approval. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543343 Wed, 25 Jun 2008 15:00:12 +0100 1543343 http://www.medworm.com/index.php?rid=1543932&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F319728360%2F For Merck, this is ‘one less’ approval. The agency bounced the drugmaker’s request to approve its HPV vaccine for women between ages 27 and 45, citing “issues that preclude approval within the expected review timeframe,” but there was no more specific info provided in Merck’s statement. The drugmaker says it has already discussed with the FDA the questions related to the application and expects to respond to the agency next month. Gardasil, you may recall, was approved in 2006 for girls and women between 9 and 26 years old to prevent human papillomarivus, or HPV, which can lead to cervical cancer caused by the human papillomavirus. Merck, however, added the FDA identified several issues related to the application in a “complete response” lett... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1543932 Wed, 25 Jun 2008 14:04:05 +0100 1543932 http://www.medworm.com/index.php?rid=1535948&cid=t_100786_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F316685691%2F GlaxoSmithKline has won a contract with the UK’s NHS to supply its cervical cancer vaccine, Cervarix. The battle to supply a vaccine against cervical cancer for use across Britain has been won by GlaxoSmithKline (GSK). Cervarix, the GSK vaccine, will be given to girls aged between 12 and 13, starting in September this year, and should prevent about 70 per cent of cervical cancers — saving 400 lives a year when the effect is fully felt. Read more from The UK Times Online. Let’s wait and see what Merck (maker of the other cervical cancer vaccine Gardasil) has to say about this. Tags: CErvarix, cervical-cancer, cervical-cancer-vaccine, Gardasil, GlaxoSmithKline, Merck, UK NHSShare This (Source: Cancer Commentary) Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=1535948 Sat, 21 Jun 2008 04:48:23 +0100 1535948 http://www.medworm.com/index.php?rid=1531139&cid=t_100786_87_f&fid=34595&url=http%3A%2F%2Fnhsblogdoc.blogspot.com%2F2008%2F06%2Fgenital-warts.html Not available from the NHSThe whole of Western Europe, the United States, Australia, New Zealand and Canada have decided to use the Garadasil vaccine to protect their teenagers against cervical cancer and a variety of genital warts. The whole of Western Europe that is except for the United Kingdom. Our government has decided to purchase the cheaper and less effective Cervarix which protects against a narrower spectrum of HPV infections.So when British teenagers start to suffer from these (warning : graphic pictures) we will know who to blame.My children will be having Gardisil, and I shall be prescribing it on demand to any one who wants it unless or until someone stops me. Then I shall advise “topping up” your second rate health care by buying it privately.And why are we not giving it... NHS Blog Doctor blogs http://www.medworm.com/rss/comments.php?id=1531139 Fri, 20 Jun 2008 13:41:00 +0100 1531139 http://www.medworm.com/index.php?rid=1531224&cid=t_100786_150_f&fid=34768&url=http%3A%2F%2Fpharmagossip.blogspot.com%2F2008%2F06%2Fcervix-wars-score-one-for-cervarix.html The Department of Health has announced that the national contract for human papillomavirus vaccine (HPV) has gone to Cervarix®. This announcement has also been reported in the general media (BBC, The Times).As previously noted, Gardasil® has a wider range of licensed indications based on the current Summaries of Product Characteristics (Cervarix and Gardasil). In addition to the wider range of indications, Gardasil is also licensed in a wider age group and for both genders.The official announcement notes that the decision was based on a wide range of criteria such as their scientific qualities and cost effectiveness but that the price remains commercially confidential.At a time when the NHS has a significant cash surplus it must be hoped that, for reasons of transparency, the rationale f... PharmaGossip blogs http://www.medworm.com/rss/comments.php?id=1531224 Thu, 19 Jun 2008 08:39:00 +0100 1531224 http://www.medworm.com/index.php?rid=1509070&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F309779723%2F The drugmaker is urging docs to distribute a spiffy new brochure after administering the HPV vaccine in hopes teens and women will return for their second and third shots. However, the brochure, which is part of Merck’s ‘3 Is Key’ campaign, is worded in such a way that the drugmaker may wind up collecting personal info from teens that could be used for market research. We’ve included a link to the brochure, so you can judge for yourself. Here’s what we see: the brochure asks for personal data - name, address, birth date and e-mail addess - as well as a signature, but doesn’t stipulate that a parent or legal guardian must sign, instead of the teen. There’s also a line indicating the personal data will be used for ‘market research purposes.&#82... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1509070 Wed, 11 Jun 2008 17:28:45 +0100 1509070 http://www.medworm.com/index.php?rid=1488698&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F303135568%2F What a difference a year makes. Last year, Merck was under fire for aggressively promoting its HPV vaccine by convincing lawmakers, such as the governor of Texas and legislators who belong to Women In Government, to get behind mandatory vaccination. The heavy-handed effort backfired, briefly obscuring a meaningful discussion of health benefits and sullying the drugmaker’s reputation. And so Merck scaled back its more visible lobbying, although Gardasil ads continued to run. Now, the drugmaker is getting aggressive again - especially with consumers. Starting this past Saturday and running through June 26, Gardasil ads are appearing in theaters showing ‘Sex and the City,’ ‘Get Smart,’ ‘The Happening,’ ‘You Don’t Mess With The Zohan,&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1488698 Mon, 02 Jun 2008 18:19:23 +0100 1488698 http://www.medworm.com/index.php?rid=1401385&cid=t_100786_87_f&fid=35052&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FWomensBioethicsBlog%2F%7E3%2F278270428%2Fadding-to-our-collection-of-posts-about.html Adding to our collection of posts about Gardasil and the HPV vaccine is the news that HPV is one of two viral links to lung cancer. Two new studies suggest that viruses - specifically, HPV and... [[ This is a content summary only. Visit my website for full links, other content, and more! ]] (Source: Women's Bioethics Blog) Women's Bioethics Blog blogs http://www.medworm.com/rss/comments.php?id=1401385 Sat, 26 Apr 2008 13:21:18 +0100 1401385 http://www.medworm.com/index.php?rid=1399636&cid=t_100786_150_f&fid=36939&url=http%3A%2F%2Fscientific-misconduct.blogspot.com%2F2008%2F04%2Fgardasil-scandal-university-of.html Just after my last post on the role of a University I read this piece in today's British Medical Journal about an appalling episode at the University of Queensland that goes right to the heart of what a University is. The University of Queensland has broken its contract with the scientific community. This is an absolute disgrace. I am reminded of the letters to me stating that I needed University "authorisation" to discuss issues of scientific procedure. I recall the warning of "public dissociation" and that "public interest disclosure legislation" somehow applied to discussion of scientific methodology involving Procter and Gamble. From the University secretary and registrar at Queensland (Douglas Porter) this most absurd of comments:Douglas Porter, wrote to Dr Gunn, asking him to provide... Scientific Misconduct Blog blogs http://www.medworm.com/rss/comments.php?id=1399636 Sat, 05 Apr 2008 18:53:00 +0100 1399636 http://www.medworm.com/index.php?rid=1314432&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F254359690%2F The FDA will consider whether to expand the HPV vaccine for women between 27 and 45 years old, according to a statement from the drugmaker. You may recall that Gardasil is currently approved for use in girls and women between 9 and 26 years old to block four types of humanpapilloma virus, which can lead to cervical cancer and genital warts. A decision is expected this summer. This, of course, would greatly increase the market for Gardasil. The question then becomes what kind of marketing campaign will Merck employ to promote the vaccine. The news comes, by the way, a year after the controversy over its aggressive marketing push. At that time, Merck attempted to influence Women In Government, which actively promotes the vaccine. Several legislators around the country who belong to the non-p... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1314432 Wed, 19 Mar 2008 15:58:58 +0100 1314432 http://www.medworm.com/index.php?rid=1215497&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F230982477%2F Sanofi-Pasteur is criticizing Glaxo’s new Cervarix in an attempt to bolster its lead in the burgeoning market for HPV vaccines, The Financial Times writes. The vaccine maker, which sells Merck’s Gardasil in Europe, has been wooing investors this week with presentations claiming greater proven health benefits from Gardasil in preventing human papilloma virus infections, which is the leading cause of cervical cancer. Didier Hoch, who heads a joint venture between Sanofi-Aventis and Merck for European vaccine marketing, says published Glaxo results on Cervarix were less conclusive and dismissed as “a marketing gimmick” a clinical study that directly compares the two products. He lambasted the head-to-head study of Cervarix and Gardasil for its small sample size, use of... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1215497 Thu, 07 Feb 2008 13:33:03 +0100 1215497 http://www.medworm.com/index.php?rid=1177898&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F222894728%2F The European Medicines Agency posted a statement yesterday saying there have been two sudden and unexpected deaths in young women who had received the Merck HPV vaccine, which is marketed in Europe by Sanofi-Aventis. But the EMEA decided not to change the labeling info, given that 1.5 million women have already been vaccinated in Europe and because no causal relationship between the vaccine and the two fatalities has been found. One death occurred in Austria and the other in Germany. In both cases, the cause of death could not be identified, says the agency. However, the EMEA will continue to monitor Gardasil for safety issues. The cases were widely reported in the Austrian and German press earlier this month. (Here is a translation of one story that appeared in Der Standard). This is not... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1177898 Fri, 25 Jan 2008 12:42:01 +0100 1177898 http://www.medworm.com/index.php?rid=1149830&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F216553797%2F Another busy Monday morning. We hope yours is going as well as ours. As we track various interesting developments, here are a few more items to help you prepare for the rest of the day… USPTO Rejects Pfizer’s Basic Lipitor Patent (Yahoo/Reuters) France Backs Use Of Merck’s Gardasil Over Glaxo HPV Vaccine (Yahoo/Reuters) Maryland Court Rejects Thimerosal-Autism Link In Wyeth Vaccine (Yahoo/Reuters) Avalon Pharma Signs Development Deal With Novartis (The Baltimore Sun) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1149830 Mon, 14 Jan 2008 17:48:36 +0100 1149830 http://www.medworm.com/index.php?rid=1128852&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F210791301%2F In recent months, health officials say they’ve noticed an increasing number of reports of fainting associated with Gardasil, the Associated Press writes. From 2002 to 2004, there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on the market in 2006. But it’s not clear that Gardasil’s sting is related to the fainting increase, Barbara Slade, an immunization safety specialist at the CDC, tells the AP. Health officials also note more complaints that the vaccine is painful. Teens, however, tend to faint from needles, so a three-dose vaccine for adolescents would be expected to prompt some added fainting, she says. Researchers aren’t sure why teens faint more than other a... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1128852 Thu, 03 Jan 2008 23:22:41 +0100 1128852 http://www.medworm.com/index.php?rid=1098893&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F201605490%2F This is another blow for the drugmaker, which is still reeling from the controversy over its Avandia diabetes pill and the subsequent lost revenue. Now, the FDA has issued a so-called ‘complete response letter’ for its Cervarix vaccine. Although it’s not clear, though, whether the agency wants additional trials, leaving open the possibility that the unexpected delay in approval can last anywhere from just six months to up to two years. “We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses,” Barbara Howe, vp and director for Glaxo’s North American vaccine development, says in a statement. “Our discussions with the agency continue to be positive and constructive, and we are working dil... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1098893 Mon, 17 Dec 2007 12:07:39 +0100 1098893 http://www.medworm.com/index.php?rid=1005216&cid=t_100786_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F180134988%2Fmercks_gardasil_for_hpv_protects_older_women_also.html Merck & Co. (NYSE:MRK) released a study that its Gardasil HPV (human papillomavirus) vaccine may offer protection to women over the current FDA approved age range of 9 to 26.The study, which consisted of 3,800 women between the ages of 24 and 45, produced data showing that the vaccine prevented 91 percent of cases of persistent infection, monir cervical abnormalities, pre-cancers and genital warts caused by 4 strains of sexually transmitted HPV."This is the first efficacy study in this age population," Dr. Eliav Barr, who heads the Merck HPV Vaccine program, said. "The vaccine performed as we expected. It was highly effective."Merck's goal now is to submit the data from the study to the U.S Food and Drug Administration to get approval to market the vaccine ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1005216 Mon, 05 Nov 2007 16:15:31 +0100 1005216 http://www.medworm.com/index.php?rid=1003708&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F180029611%2F That’s what Merck is touting as the result of its latest study of the HPV vaccine, which so far is approved for girls and women ranging in age from 9 to 26 years of age. In a study of 3,800 women aged 24 to 45, the vaccine prevented 91 percent of cases of persistent infection, minor cervical abnormalities, pre-cancers and genital warts caused by four different HPV strains. “This is the first efficacy study in this age population,” Eliav Barr, who heads the Merck HPV Vaccine program, tells Reuters. “The vaccine performed as we expected. It was highly effective.” The company-funded study, presented at the 24th International Papillomavirus Conference in Beijing, China, found that Gardasil prevented 83 percent of infections, cervical abnormalities and pre-cancers ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1003708 Mon, 05 Nov 2007 11:55:06 +0100 1003708 http://www.medworm.com/index.php?rid=989735&cid=t_100786_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177174813%2Fuk_to_vaccine_school_girls_against_hpv_gks_and_merck_vie_for_contract.html In what can only be seen as a huge bonus for Merck & Co. (NYSE:MRK) and GlaxoSmithKline Plc's (NYSE:GSK) , the U.K government has announced that it will begin vaccinating all girls between the ages of 12 and 13 as of next September against human papilloma virus (HPV).Marketed as Gardasil by Merck and Cervarix by GlaxoKlineSmith, both companies are competing for the government contract to immunize all those British school girls.The vaccine is purported to be most effective on girls who have yet to begin their sexual lives but may also be beneficial to women aged 24 and older depending on their exposure to HPV and their level of sexual activity. The vaccine protects against 70 percent of HPV strains leaving 30% of the HPV strains unprevented and thus leaving a chance f... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=989735 Mon, 29 Oct 2007 21:15:10 +0100 989735 http://www.medworm.com/index.php?rid=982729&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F175388616%2F The UK’s Health Minister announced today that, starting in September, girls who are 12 and 13 years old can get vaccinated, although the shots won’t be mandatory. A catch-up campaign to vaccinate girls up to 18 years old will start in 2009. “This is an exciting step towards preventing cervical cancer in the UK,” says Harpal Kumar, Cancer Research UK’s ceo. “Prevention is always better than cure and this vaccine will prevent many women from catching the human papilloma virus in the first place, potentially saving around 400 hundred lives a year,” says health minister Alan Johnson in a statement. But which vaccine? That hasn’t been decided. Both Merck’s Gardasil and Glaxo’s Cervarix are approved in Europe and priced comparably, set... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=982729 Fri, 26 Oct 2007 14:30:52 +0100 982729 http://www.medworm.com/index.php?rid=968447&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F173295971%2F The drugmaker reported a 62 percent increase in third-quarter earnings, as revenues rose by double digits thanks to sales of the Gardasil HPV vaccine, the new Januvia diabetes pill. Meanwhile, marketing costs and research and development spending rose. Net income was $1.53 billion, or 70 cents per share, compared with $940.6 million, or 63 cents, a year earlier, beating Wall Street estimates of 69 cents. Revenues totaled $6.07 billion, up from $5.4 billion. R&D spending rose 18 percent, excluding a charge, and including a particularly large milestone payment to one of its partners. Marketing costs rose 6 percent, before a $70 million charge for Vioxx litigation. Vioxx reserves now stand at $720 million, but this is only to cover the cost of defending lawsuits; the drugmaker hasn&#8217... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=968447 Mon, 22 Oct 2007 11:34:13 +0100 968447 http://www.medworm.com/index.php?rid=954383&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F170652354%2F That’s what Margaret McGlynn, who heads the drugmaker’s vaccine business, tells The Star-Ledger of New Jersey in an interview. She insists the controversial effort to require adolescent girls to receive the HPV vaccine, which is designed to thwart cervical cancer, was the doing of Women In Government, an ad-hoc collection of state legislators. However, McGlynn acknowledges funding the group and was aware of its interest in cervical cancer. Just to be clear, earlier this year, Richard Haupt, Merck’s director of medical affairs, said the drugmaker has “decided at this point not to lobby for school laws any further,” and admitted the controversy was a distraction. SL: The strategy of getting states to mandate Gardasil for school girls got swept up in controversy and, ult... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=954383 Tue, 16 Oct 2007 13:34:31 +0100 954383 http://www.medworm.com/index.php?rid=937217&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F167423411%2F Judicial Watch, which bills itself as a conservative public interest group that “advocates high standards of ethics and morality in our nation’s public life,” is again making news by releasing FDA side effect reports showing an increase in adverse events attributed to Merck’s HPV vaccine. The group did the same thing last May, so it’s not surprising the tally rose, given that Gardasil has been more widely administered since then. Nonetheless, Judicial Watch says that, after obtaining the info through a Freedom of Information Act request, the FDA received 1,824 adverse reaction reports, including as many as eight deaths. Previously, the group received 1,637 such reports and notes that a total of 11 deaths are now among the side effect reports to the agency. You can... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=937217 Tue, 09 Oct 2007 14:14:09 +0100 937217 http://www.medworm.com/index.php?rid=938756&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F10%2Fgardasil-is-risk-of-being-one-less.html Merck & Co's new cervical cancer vaccine Gardasil could be linked to as many as 11 deaths since its approval in the market according to FDA documents obtained by US public interest group Judicial Watch under the Freedom of Information Act (see "New concerns raised over Merck’s Gardasil").20-Jun-2007: Information has been received…concerning a 17 year old female who in June 2007…was vaccinated with a first dose of Gardasil…During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died. (Among the new information uncovered by Judicial Watch.)Whether these deaths are actually attributable to the vaccine or represent "a temporal rather than cau... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=938756 Tue, 09 Oct 2007 12:39:00 +0100 938756 http://www.medworm.com/index.php?rid=931124&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F10%2Fgardasil-i-could-become-one-less.html That is, one less male that transmits the human papillomavirus -- thought to be a major cause of cervical cancer in women -- if Merck has its way."Men are the key transmitters of human papillomavirus," Elmar Joura, a professor at the University of Vienna medical school, said last month. "There are real clinical grounds for giving Gardasil to boys as a primary health measure.""Gardasil use is rising faster than any new vaccine, and giving it to boys and young men as well as girls may push annual sales potential above $10 billion, says Lisa Kelly, an analyst at Wood Mackenzie Consultants Ltd. in Edinburgh. That would make Gardasil Merck's best-seller." (See "Gardasil Sales: $10b per Year?").Merck's first hurdle, of course, is getting FDA to approve a new indication for men (boys, actually; o... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=931124 Fri, 05 Oct 2007 15:11:00 +0100 931124 http://www.medworm.com/index.php?rid=919096&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F164152049%2F And so another day has begun. We hope yours is getting off to a good start. For us, it is a bright beginning - the dog has pooped, the heirs are off to school and the hot coffee is beckoning… Roche has promoted Juergen Schwiezer to head its diagnostics division, replacing Severin Schwan, who becomes ceo on March 4. Schwiezer, 62, who leads the unit in Europe and Latin America, starts on Jan. 1. Franz Humer, the currrent ceo, will remain chairman and Schwan, 40, who joined Roche as finance officer in 1993, will become the youngest ceo to ever run Roche. Glaxo will charge $490 for a full course of Cervarix, its new HPV vaccine, in the UK and Germany, which matches the price set by Merck for Gardasil. The Glaxo vaccine goes on sale in the two countries today, although the European Unio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=919096 Tue, 02 Oct 2007 10:50:32 +0100 919096 http://www.medworm.com/index.php?rid=919097&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F163968368%2F We apologize for delay since our last post, and the late sign-off, as well. We were meeting with a few people from, well, we shouldn’t say. But we do try to get out and about now and then, if only to hear the latest about whomever and whatever. So we appreciate your patience. Now, we will attempt to recharge before resuming the routine in the morning. Sleep well, everyone. We look forward to seeing you again shortly… FDA To Review Affect Of Osteoporosis Drugs On The Heart (Bloomberg News) Increased Options Activity In Bristol-Myers Squibb (The Wall Street Journal - subscription required) Glaxo’s Cervarix Priced At Same Level As Gardasil In The UK (Yahoo/Reuters) Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=919097 Tue, 02 Oct 2007 01:10:59 +0100 919097 http://www.medworm.com/index.php?rid=906067&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F09%2Fpoe-dtc-forevermore.html Once upon a Nightly News show dreary, while I pondered, weak and weary,Over many a quagmire and unending war,While I nodded, nearly napping, suddenly there came a drug ad,As of someone violently sneezing, wheezing, or erectile poor."'Tis some me-too drug," I muttered, "for the erectile poor;Only this, and nothing more."Not THAT Poe!It's time again for the POE awards! No, not the Edgar Allan Poe awards but the Perspectives on Excellence Awards -- a yearly event sponsored by DTC Perspectives (see "DTC Perspectives Magazine Announces Finalists for the POEs Awards").I reviewed the POE winners of last year after the fact (see "Awards: The Good, The Bad, The Ugly"), but this year I'd like to review the contenders and give readers an opportunity to vote before the winners are announced at the DTC... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=906067 Wed, 26 Sep 2007 11:04:00 +0100 906067 http://www.medworm.com/index.php?rid=903795&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F161090204%2F So who was behind Gardasil? A key player was University of Washington epidemiology professor Laura Koutsky (pictured to the left), who’s credited with developing the HPV vaccine along with Kathrin Jansen, a yeast expert then at Merck Research Laboratories. Her studies, published in the New England Journal of Medicine and the American Journal of Epidemiology, examined the disease’s natural history — what causes cervical cancer and HPV, who gets it and when. Without knowing those basics, it would have been impossible to make a vaccine, writes The Seattle Times, which profiles the researcher. After a key clinical trial found that Gardasil worked against a prevalent HPV strain, they had to decide which strains to include in the vaccine that would go to the public. “Everyone... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=903795 Tue, 25 Sep 2007 14:30:15 +0100 903795 http://www.medworm.com/index.php?rid=901030&cid=t_100786_136_f&fid=36051&url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F161036890%2F Speaking of cervical cancer vaccines, there are two notables: Gardasil by Merck which was approved by the FDA earlier this year and Cervarix by GlaxoSmithKline which is expected to be approved by the FDA later this year (but already approved in Australia). Regarding these HPV vaccines that will protect women against cervical cancer, the CDC recommends that the vaccine should be routinely given to girls at 11-12 years of age – the stage before young girls are more likely to become sexually active. Now there is a new project that will evaluate and monitor the effectiveness of these vaccines. The said project -funded by the national Centers for Disease Control and Prevention (CDC) - will be jointly conducted by the University of Rochester Medical Center (URMC) and the New York State Depart... Cancer Commentary blogs http://www.medworm.com/rss/comments.php?id=901030 Tue, 25 Sep 2007 11:58:23 +0100 901030 http://www.medworm.com/index.php?rid=894335&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F160564679%2F And so we all return from the weekend. Hope yours was enjoyable. Ours was splendid. We managed to mow the lawn yesterday, a rare event that met with the approval of the neighbors (not that we care all that much). And we took the shortest of the short people on a hayride to pick a few pumpkins. Now, though, we are again scouring the world for interesting insights. Here are a few of the latest… EU Delays Schering-Plough, Organon Review For Two Weeks (CNNMoney/Dow Jones) EU Approves Pfizer’s Selzentry AIDS Drug (Yahoo/Reuters) Glaxo Wins EU Approval To Sell Cervarix HPV Vaccine (Bloomberg News) Novartis’ Exelon Alzheimer’s Patch Approved By EU (CNN/Thomson Financial) Lilly Sues Sun Pharma To Block Generic Version Of Strattera (Bloomberg News) FDA Delays Approval Of Gla... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=894335 Mon, 24 Sep 2007 11:10:00 +0100 894335 http://www.medworm.com/index.php?rid=784114&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F141502565%2F What better way to advertise to other beachgoers that you’re free of a sexually transmitted disease than to wrap yourself in this nicely designed terry velour towel, which measures 30 inches by 60 inches. Catch a wave and then use the towel to make clear to that attractive person nearby that genital warts or HPV won’t be a problem. Truly, this is a new way to advertise the advantages the vaccine has to offer. Frisky teenagers will love them! Share / E-mail (Source: Pharmalot) Pharmalot blogs http://www.medworm.com/rss/comments.php?id=784114 Tue, 07 Aug 2007 12:19:54 +0100 784114 http://www.medworm.com/index.php?rid=774274&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F139765985%2F Will this cause a ruckus? The federal agency is launching a new web site urging pre-teens to receive the HPV vaccine, among others. The agency, which wants to promote immunization among youngsters against several diseases, will also print posters and checklists on the shots for doctors’ offices, according to a statement on its web site. Heath officials are looking for ways to promote Gardasil, since HPV can lead to cervical cancer, and are relying on mandates, subsidies and recommendations, says Anne Schuchat, the director of CDC’s National Center for Immunization and Respiratory Diseases. “This is the first vaccine available to prevent cervical cancer,” she tells Bloomberg News. “Using it at 11 or 12 years of age is the best time for the vaccine to be given,... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=774274 Thu, 02 Aug 2007 01:04:23 +0100 774274 http://www.medworm.com/index.php?rid=751696&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F07%2Fmandatory-vaccination-controversy-did.html According to the Wall Street Journal health Blog:"Looking at the numbers Merck is posting for sales of its cervical-cancer vaccine Gardasil, the Health Blog can’t help but wonder whether Merck really needed to even try its controversial lobbying push to boost the vaccine’s sales." (See "Gardasil Gives Merck Shot in the Arm").Although sales of Gardasil were $358 million in the second quarter, following a first-quarter showing of $365 million, this doesn't mean that the slight decrease was due to the controversy that erupted in February after it was discovered that Merck was lobbying state legislatures for mandatory vaccination program for preteen girls (see "Gardasil: To Be Mandatory or Not To Be Mandatory -- That is the Question").As pointed out by the WSJ blog, "A fall in Gardasil sal... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=751696 Mon, 23 Jul 2007 18:54:00 +0100 751696 http://www.medworm.com/index.php?rid=728649&cid=t_100786_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F132769411%2F The French government has agreed to subsidize the HPV vaccine made by Merck for teenage girls and young women, but coverage depends largely upon the patient’s virginity. That’s right. No cherry, no shot. Well, almost. The vaccine is being mandated for 14-year-old girls, regardless of their sexual practices, Sanofi-Aventis spokeswoman Armelle Bouvier tells CNNMoney.com. But girls and women aged 15 to 23 will qualify for 65 percent government coverage only if they are virgins, or lost their virginity within the past year. Shtupping a long time? Forget about it. Bouvier says the policy was established by French health authorities, not the drugmaker, and that the virginity or sexual activity of individual patients would be determined by docs. The idea is to save money, since a thre... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=728649 Wed, 11 Jul 2007 21:24:11 +0100 728649 http://www.medworm.com/index.php?rid=721326&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F07%2Fmarketings-new-maxim-at-least-do-no.html The most famous phrase never uttered in the Hippocratic oath taken by physicians is "First, do no harm." (See "Not in the Hippocratic Oath").Marketing should have its own "Hippocratic Oath" and its first principle or maxim should definitely be "Do no harm."As far as pharmaceutical marketing is concerned, this principle needs to cover at least two different types of harm:1. Financial Harm, and2. Reputation HarmEveryone assumes that marketing benefits a company's bottom line. But a recent study summarized in AdvertisingAge failed to demonstrate this. Instead, the study could only conclude that marketing does not harm the bottom line:A study to be published in the Journal of Marketing that covered 167 companies including Procter & Gamble, Microsoft and Apple over a five-year period concludes ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=721326 Mon, 09 Jul 2007 12:27:00 +0100 721326 http://www.medworm.com/index.php?rid=687694&cid=t_100786_87_f&fid=34595&url=http%3A%2F%2Fnhsblogdoc.blogspot.com%2F2007%2F06%2Ftarts-cancer-jab-will-ruin-lives.html Expensive at the point of entry"Gardasil is almost 100% effective against Human Papilloma Virus, the main cause of cervical cancer, which can be fatal, and genital warts. It is now being prescribed in Britain , with calls for the 'wonder drug' to be administered wholesale to school-girls. Cervical cancer charity Jo's Trust has called for a nation-wide programme of vaccination in secondary schools to be launched by the end of the year, even though no tests have been done on girls of that age and long-term side-effects are as yet unknown.The use of the vaccine which prevents cervical cancer has been condemned by a Christian prayer and lobby group."Stephen Green, National Director of Christian Voice, said today:'The best way of not g... NHS Blog Doctor blogs http://www.medworm.com/rss/comments.php?id=687694 Thu, 21 Jun 2007 15:12:00 +0100 687694 http://www.medworm.com/index.php?rid=675618&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F06%2Fcause-marketing-via-youtube-what-pharma.html Michael Moore, the creator of the documentary SiCKO (reviewed here), is entering a new realm of politics by soliciting videos from Americans chronicling their healthcare horror stories."I got to thinking after finishing the film," says Moore in his video pitch, "now that's there's YouTube, [I have a great chance] to ask those of you who are out there to send me your own healthcare stories...so if you videotape your story and send it here, I'll post it [on YouTube] and also take these YouTube videos to our members of Congress ...If we do this, there's a chance to get some action going."Here's Moore's pitch on YouTube:Moore posted his video on June 6, 2007 and already it has received over 225,000 views, 171 comments and 14 video responses.Moore has established a group on YouTube where these ... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=675618 Sat, 09 Jun 2007 12:09:00 +0100 675618 http://www.medworm.com/index.php?rid=650972&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F06%2Fweekly-pharma-news-review.html There's so much news coming out about the pharmaceutical industry that I would love to comment on, but I haven't the time. Here are a few stories that came across my desk this week that fall into that category. By your clicks, I can determine which ones I may dive into deeper in future posts to this blog.Ketek: Drug's chilling path to marketAventis Pharmaceuticals Inc. thought it had a blockbuster in Ketek pronounced kee-tek. It would be marketed as the next amoxicillin, a widely used antibiotic to treat the sinusitis and bronchitis that plague millions of Americans each year.But before Ketek could come to market, the FDA required proof that the expensive new drug was at least as good as the existing treatment. So Aventis devised Study 3014, a clinical drug trial involving 1, 800 private p... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=650972 Fri, 01 Jun 2007 17:44:00 +0100 650972 http://www.medworm.com/index.php?rid=629100&cid=t_100786_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F05%2F21%2Fcervical-cancer-vaccine-gardasil-reducing-the-risk-of-other-canc%2F Filed under: Drug, Prevention, Cervical Cancer, ResearchGardasil, a vaccine against four types of the human papillomarivus (HPV), may reduce the risk of cancers of the vagina and vulva in addition to reducing the risk of cervical cancer. The HPV virus can lead to precancerous or cancerous changes to the cervix, vagina, penis and anus. Researchers combined information from three clinical trials to evaluate the effectiveness of Gardasil on the risk of precancerous changes to the vulva and vagina. The study found that among women who had not been infected with the HPV virus, Gardasil was 100 percent effective against precancerous changes to the vulva or vagina. Among those that had been infected with a certain strain of the HPV virus, Gardasil was 71 percent effective. Gardasil was 49 percent... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=629100 Mon, 21 May 2007 04:00:00 +0100 629100 http://www.medworm.com/index.php?rid=602480&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F05%2Fgardasil-less-hype-may-help.html As reported in today's Wall Street Journal:"An editorial published in the New England Journal of Medicine raises questions about the overall effectiveness of Merck & Co.'s cervical-cancer vaccine, Gardasil, and advises policymakers, doctors and parents to adopt "a cautious approach" toward vaccination. (See "Medical Journal Questions Gardasil Efficacy").At issue is how effective Gardasil actually is. As always, it comes down to analysis of the data and which expert you believe.Whereas Merck claims 98% efficacy against 2 types of HPV virus that cause cervical cancer, this drops to 17% when looking at data from another group and the authors of the NEJM editorial called the vaccine's overall efficacy against precancerous lesions of the cervix "modest."This is not the message that Merck delive... Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=602480 Thu, 10 May 2007 11:39:00 +0100 602480 http://www.medworm.com/index.php?rid=534114&cid=t_100786_87_f&fid=34865&url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F04%2F10%2Fgay-bisexual-men-lobby-for-hpv-vaccine%2F Filed under: Drug, Prevention, Research, Daily news, Anal cancerIt's not yet clear if the drug Gardasil, the vaccine intended to prevent the human papillomavirus (HPV) in females, is effective for men. But some men are signing up for the chance to take the drug.Gay and bisexual men in San Francisco are asking their doctors for the vaccine with hopes it will prevent anal and penile cancer, also caused by HPV. "The prevalence of anal cancer among gay and bisexual men is very high," says Jason Riggs, spokesman for the STOP AIDS Project. "So that's why some people are looking at this as a possible preventive cure for anal cancer and HPV that causes anal cancer." Anal cancer occurs among gay and bisexual men at a rate 35 times higher than that of the general population. And it occurs mor... The Cancer Blog blogs http://www.medworm.com/rss/comments.php?id=534114 Tue, 10 Apr 2007 04:00:00 +0100 534114 http://www.medworm.com/index.php?rid=479359&cid=t_100786_150_f&fid=34889&url=http%3A%2F%2Fpharmamkting.blogspot.com%2F2007%2F03%2Fdoes-merck-need-vaccine-for-bad-pr.html (Source: Pharma Marketing Blog) Pharma Marketing Blog blogs http://www.medworm.com/rss/comments.php?id=479359 Thu, 01 Mar 2007 15:00:00 +0100 479359 http://www.medworm.com/index.php?rid=470433&cid=t_100786_117_f&fid=34775&url=http%3A%2F%2Fblogs.webmd.com%2Fhealthy-children%2F2006%2F07%2Fcervical-cancer-vaccine-follow-up-good.html In March, I wrote a blog called "Cervical Cancer Vaccine: The good, the bad and the ugly". In it I talked about an effective and safe new vaccine ("the good") to prevent contracting human papilloma virus (HPV), by far the leading cause of cervical cancer.The "ugly" was my concern over mounting attacks on the HPV vaccine by those who inisisted it would encourage teens to have sex - to my mind a dubious and dangerous assertion (e.g., in a recent study of virgins, only 7-10% said "fear of a sexually transmitted disease" was a reason not to have sex).Take a look at the blog and especially the fascinating, provocative debate that followed in the comments.*****************************************Dr. P's fears were unfoundedI'm pleased to report my concerns of an effective opposition to this valu... Healthy Children blogs http://www.medworm.com/rss/comments.php?id=470433 Tue, 11 Jul 2006 04:00:00 +0100 470433