Reported by David Jolly

With the purchase, Merck is expanding its franchise in cardiovascular, respiratory and oncology drugs and shoring up its research pipeline, in particular with a Schering-Plough product called TRA, a promising drug designed to prevent blood  clotting.

In addition, Merck will benefit from the worldwide reach of Schering- Plough, which generates about 70 percent of its sales outside the United States, including more than $2 billion in annual revenue from emerging markets.

The companies said in a joint statement that the merged company would keep the name Merck and that the deal had been unanimously approved by their boards. Richard Clark, Merck’s chairman and chief executive, will lead the combined company.

The deal is the second major pharmaceutical deal this year after Pfizer, the world’s biggest drug maker, agreed in January to pay $68 billion for Wyeth. And Roche, the Swiss pharmaceutical company, is pursuing a full acquisition of the California biotechnology company Genentech, in which it already owns a majority stake.

Merck is among the drug makers that face the hardest time in the next decade because of patent expirations, said Richard Purkiss, a drug sector analyst at Atlantic Securities in London. Most pressingly, it faces the expiration in 2012 of the patent on Singulair, the asthma drug that is its top-selling product.

In contrast, “Schering- Plough doesn’t have much exposure to patent expiries in the same time frame,” he said. “This is really about combining to protect earnings.”

Shares of Schering- Plough rose more than 8 percent Friday amid speculation that the company had been pursuing a deal with either Merck or Johnson & Johnson, with which it jointly produces the arthritis drug Remicade.

Under the terms of the agreement announced Monday, Schering-Plough shareholders will receive 0.5767 share of the combined company and $10.50 in cash for each share of Schering-Plough. Each Merck share will automatically become a share of the combined company. Based on Merck’s closing stock price Friday, the deal values Schering-Plough at $23.61 ar share, or $41.1 billion, a premium to Schering-Plough shareholders of about 34 percent.

The 44 percent of the deal that is being paid in cash will include $9.8 billion from existing cash balances and $8.5 billion from financing provided by JPMorgan Chase.

Merck shareholders will own about 68 percent of the merged company, and Schering-Plough shareholders will own the rest. Merck said it expected the deal to contribute “modestly” to its earnings in the first year and “significantly”  thereafter.

“We are creating a strong, global health care leader built for sustainable growth and success,” Clark said in the statement. “The combined company will benefit from a formidable research and development pipeline, a significantly broader portfolio of medicines and an expanded presence in key international markets, particularly in high-growth emerging markets. The efficiencies we gain will allow us to invest in strategic opportunities, while creating meaningful value for  shareholders.”

The transaction will be structured as a “reverse merger” in which Schering-Plough, renamed Merck, will continue as the surviving public company.

Merck said it expected annual cost savings of about $3.5 billion after 2011. The savings “are expected to come from all areas across the combined company and from the full integration of the Merck/Schering-Plough Pharmaceuticals cholesterol joint venture,” it said, and are in addition to previously announced cost-cutting measures at the two companies.

David Moskowitz, an analyst at Caris & Co. in New York, suggested that the companies might have to raise the offer price above $23.61.

“I think it should be at least $12 billion to $15 billion higher,” he told Reuters, as investors might not be happy until the price reaches “the high $20s or $30″ a share.

©2012 An Inconvenient Woman. All Rights Reserved.

Consumers can only  hope. Of course if  MERCK corporate lawyers figure out that such an open source platform may lead to a clear chain of custody of the type of information they would rather not have readily available during a trial environment, we will see who prevails, the scientist or the lawyers

Reported by Kevin Davies

March 3, 2009 | SAN FRANCISCO – Merck scientists and executives Stephen Friend and Eric Schadt unveiled their plans for Sage, an open-access platform for sharing and disseminating complex data representing disease biology, in a major announcement at CHI’s Molecular Medicine Tri-Conference last week.*

In a joint presentation, Friend, Merck senior vice president and former oncology chief, and Schadt, an outstanding researcher based at Merck’s Seattle subsidiary Rosetta Inpharmatics, reviewed the successes and outstanding challenges that prompted them, with Merck’s blessing (in the form of money and resources) to entertain a bold new approach to improving the expense, time and productivity of drug development.

The benefits of analyzing complex bionetworks are very good, said Schadt, but “more expensive than any one company can afford.” The vision of Sage was “to create open access, integrative bionetworks, evolved by contributor scientists, to accelerate the elimination of human disease.” An all-star advisory team includes Nobelist Leland Hartwell, Sir David Lane (A*STAR Singapore), Navigenics co-founder Dietrich Stephan, Merck research chief Peter Kim, Yale’s Rick Lifton, and John Wilbanks (Science Commons).

“We need massive amounts of information appropriately integrated to build models that are predictive,” said Schadt. “Scientists across the globe involved in different areas of research need to be actively engaged in accessing these networks and contributing information back.”

The transition from a linear to a network mindset would require the generation of coherent datasets, the development of predictive models to design novel therapeutic approaches, and the leveraging of social networks and other means to foster a contributor network. “Watching the trends of public data access, we anticipate a transition of disease biology into the precompetitive space,” said Schadt. Friend added, “The concept of making disease biology a pre-competitive space is… something that we feel in the long run has an opportunity [to succeed].”

Schadt said Merck’s leadership had recognized an opportunity where donating some of its data into the public domain, forming an open access platform that will emerge from an incubator phase, would provide a potentially significant long-term understanding of disease biology.

As for why scientists should include their own data, Friend said, “picture chemistry, picture physics. The people who were originally trying to mix compounds didn’t get very far until they found molecular structures… This is the analogy for what’s going to happen in biology.” New representations of disease allow for data to be shared and layered.

The hardest part in making Sage successful may not be the technology, Friend concluded. “It’s either going to be … our institutions … that have a certain culture about what we do with data. Or it’s going to be the clinicians,” who aren’t used to presenting clinical data using defined standards.

Decade of Discovery

Over the past decade, Friend said Merck has introduced numerous bold technologies that have been successful to a degree. Widescale RNA expression profiling in tumors (in conjunction with the Netherlands Cancer Institute) led directly to the development of Mammaprint and Oncotype diagnostic tests for breast cancer metastases. But such measurements are confounded by multiple variables, making it impossible to infer causality.

Merck also championed whole-genome RNA interference (RNAi) screening. “Often we use it to choose what drug should be combined with what standard of care, and what patient is likely to respond to what therapy,” said Friend, such as identifying gene networks that influence the activity of cisplatin. But heterogeneity of samples made it almost impossible to put the results into context. “It’s like looking at a single frame in “Slumdog Millionaire” and going, Ah, that’s what that movie was about,” he said.

A third initiative, beginning around 2002, was to merge databases of clinical information and genetic information. Merck forged collaborations with European and Chinese cancer institutes, as well as the Moffitt Cancer Center, which enables Merck researchers to direct patient selection in clinical trials based on molecular signatures in the database. But Friend said that the volume of disease data amounted to “a clinical/genomic Tower of Babel” problem.

More recently, Merck has been riding the success of Schadt’s team in Seattle, which has taken major steps to harness the explosion of data and analyze biological networks to predict the physiological state of the system. “Drug companies were betting the farm on seeing things correlated with disease and beautiful patterns of expression and then developing drugs, without having any real idea of the casual nature of those patterns,” said Schadt. The key was to leverage DNA information and environmental effects. “To be competitive in the future and to impact human health, we must become masters of information,” Schadt said, displaying a picture of Aria, the all-seeing master computer from the film Eagle Eye.

Ed’S NOTE: Eric Schadt will keynote the 2009 Bio-IT World Expo on Tuesday, April 28.

*CHI’s Molecular Medicine Tri-Conference. San Francisco, February 23-26, 2009.

©2012 An Inconvenient Woman. All Rights Reserved.

eCliniqua offers PodCasts, WebCasts, White Papers and much more. Their ‘data-rich’ site is one of my primary research resources for an objective review of clinical trial process and results.

March 2, 2009 | A growing number of online social networking sites are assembling groups around particular disease types as a way of simulating interest in clinical trials and the data they’re collecting on members, according to Matthew Holt, founder and author of The Health Care Blog and co-founder of an annual Health 2.0 conference. “Some sites are talking about [crafting] business plans to help recruit clinical trial participants.”

It’s a recycled idea, disbanded by Harris Interactive a year or two ago. A patient-to-trial matchmaking service was also tried and discontinued by Veritas Medicine. These earlier approaches failed for a number of reasons, including the fact that “many steps in the recruitment and retention process relied upon other players outside the control of the matchmaker companies,” says Kenneth Getz, chairman of the Center for Information and Study on Clinical Research Participation.

Many patients were also disappointed to find a “highly limited listing” of clinical trial options and were “uncomfortable divulging personal information to for-profit companies,” says Getz. Moreover, low consumer awareness of clinical trials made it difficult to broadly reach sufficient numbers of study volunteers. “Ultimately, the per-patient cost of online matchmaking couldn’t justify the investment.”

Brian_Loew
Brian Loew
New social networking sites, “riding the wave of user-initiated online interaction,” hold more promise, says Getz. But it remains to be seen if they can successfully attract study volunteers across a variety of clinical research studies, given that awareness and trust in trials is still low and social networking sites have yet to develop the ideal business model. “Is the value in their reach or in the data they are collecting on community members?” Study sponsors and clinical research organizations will “determine whether the return-on-investment is there” over the next couple of years, he adds.

Inspire, created four years ago specifically to accelerate recruitment via social networking, is confidently giving it a shot. Inspire’s approach is to let social networking serve as “a mechanism for attachment,” says CEO Brian Loew. “You can’t create a community just about clinical trials.” Inspire can deliver “high quality patients,” screened based on a protocol’s inclusion and exclusion criteria, because it has a pre-existing relationship with members who have volunteered to be trial participants.

The first step was to build online communities around a particular disease or condition, which Inspire has done in partnership with more than three dozen non-profit health associations, says Loew. The trial recruitment service didn’t get added until last year and Inspire already has four contracts in place, two of which are with a top-five company. The contracts are for an osteoporosis and arthritis trial as well as two lung cancer studies.

“The trials are underway right now and the early indications are good,” says Loew. “For one of the [lung cancer] studies, we already have a community with ten times the number of members who meet the initial inclusion criteria.”

To the delight of trial sponsors, Inspire also offers a “quality assurance” service whereby trial participants are surveyed about their satisfaction with the investigative site, says Loew. Responses get reported, in aggregate, to companies.

Legally speaking, the fact that Inspire owns and operates the communities assuages industry’s liability concerns regarding conversations about off-label use of their products and adverse events, says Loew.

PatientsLikeMe—focused on five chronic-illness categories, including amyotrophic lateral sclerosis (ALS)—takes a different recruitment approach that is also winning industry fans. This no-advertising venue efficiently targets “those who are both eligible for and interested in information about clinical trials,” says president and co-founder Ben Heywood.

The U.S. Medical Outsourcing Group at Novartis partnered with PatientsLikeMe for a pilot multiple sclerosis (MS) clinical trial awareness program launched last May to enhance recruitment efforts for the FTY720 FREEDOMS II trial, according to a company spokesperson. The pilot consisted of a monthly awareness email sent to MS patient members, with the aim of having them visit the institutional review board- (IRB-) approved website (MSClinicalTrials.com) and be prescreened to determine potential eligibility. The pilot also included a FTY trial awareness webpage on the PatientsLikeMe site that included IRB-approved copy and links to MSClinicalTrials.com, eligibility screener, and us.novartis.com. The experience was “very positive,” the spokesperson adds. “Increased enrollment in the FTY study was not a primary driver for the pilot program, but rather a pleasant and well-received result.”

Study Enhancement

Most intriguing to PatientsLikeMe is “the suggestion by industry to use our platform to create a micro-community for patients participating in clinical trials,” says Heywood. “The goal would be to capture real-world data that supplements information between site visits. Additional safety, tolerability, and perceived efficacy data can help inform marketing and research teams in preparation for regulatory submission. This could ultimately lead to more accurate labeling and safer treatments for patients.”

PatientsLikeMe offers its trial-sponsoring partners a clinical trial awareness package, which might include aggregated data about patients in the community they’re targeting, says Heywood. “We are also in discussions with pharma about collaborating to supplement trial data they collect with patient outcome information.” PatientsLikeMe can also tell its partners about how their approved treatments are being used in the real world.

Interestingly, PatientsLikeMe initiated the first “patient-driven, real-world natural experiment” to learn if lithium arrests the progression of ALS as suggested by a February 2008 article in PNAS (Proceedings of the National Academy of Sciences). The experiment used validated outcome scales to quantify the patient experience on lithium while monitoring side effects and blood levels, says Heywood, allowing the company to amass “the largest population of ALS patients that has ever been assembled for a study of this kind from which to analyze data.”

Patients often can’t or don’t want to wait the years it takes for evidence to emerge from a formal clinical trial. In “merely months,” and for “very little money,” the study on PatientsLikeMe produced enough information to analyze, says Heywood. These types of experiments can provide “credible direction as to when a clinical trial should be conducted. As a result, patients will have a direct voice into what types of research deserve attention and significant investment.”

An Expanding Field

Online marketer Alliance Health launched its first social networking site, DiabeticConnect, last June to promote clinical trials and to date 5% of its more than 17,000 registered members have opted to be notified of trial opportunities relevant to them, says CEO Stead Burwell. On behalf of a half dozen specialized recruitment agencies, Alliance Health also drives traffic to trial screeners via email, newsletters, and online advertisements. But the trial matching service is three times more effective than other types of interactive channels in terms of successful screens, he adds. This year, Alliance Health plans to launch a new networking site every four weeks, including ones for sleep disorders, obesity, chronic pain, and heart disease.

Inclinix has learned firsthand that social networking sites can be highly effective and affordable recruitment venues, says Chief Marketing Officer Chris Sleat. “Many sponsors fear bloggers will turn against their trial, but they’ll blog positive about [a company] as long as [it is] open and honest.”

Among the sites favored by Inclinix are Twitter (a collection of blogs), Reddit, Diggit, Craig’s List, YouTube, Facebook, and MySpace, plus multiple European sites. Some of the others fall short when it comes to driving traffic to their content and then giving visitors a reason to return, says Sleat.

For well over a year now, patient recruitment firm MediciGlobal also has been successfully using social networking sites like Facebook, MySpace, and Twitter, according to president and CEO Liz Moench.

Meanwhile, more than 1,000 clinical trials researchers and health care professionals are collaborating around specific studies on the VisionTree Optimal Care (VTOC) Network. The no-ad site, launched late last year, allows physicians to “interact, refer, and discuss current issues and clinical trials” at no charge, says Adam Hawkins, director of technology. It integrates with Twitter and YouTube to share blog posts, files, and links between members. “We are working with partners who have a large patient population to allow for outreach and recruitment into clinical trials through the VTOC Network. You will see some of these in coming months.”

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

* In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

* In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

* During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

* Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC (www.nvic.org) was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.

Levine filed a lawsuit against Wyeth in state court in Vermont over alleged problems with the Phenergan label, and a jury ruled in her favor. The Vermont Supreme Court upheld the decision. In an appeal to the U.S. Supreme Court, Wyeth argued that FDA approval of medication labels precludes lawsuits in state courts filed over alleged problems with the labels (Kaiser Daily Health Policy Report, 10/3).

The current Supreme Court — “one of the most pro-business ones in 50 years,” according to the Journal — in February ruled in favor of pre-emption in a case involving the medical device company Medtronic. In addition, Justice Stephen Breyer in a “testy burst” during a recent drug-related case asked the plaintiff’s lawyer whom she would rather have in charge of whether drugs should be allowed on the market: “an expert agency, on the one hand — or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt, and don’t see those who need the drug to cure them?” According to the Journal, the Bush administration “has long promoted the idea that federal law pre-empts state lawsuits.”

Comments

Wyeth officials noted that the suit does not allege that the firm knowingly sold a dangerous product and that it complied with FDA guidelines for the drug’s label. In addition, Wyeth officials said that strengthening the label to comply with stricter Vermont law would have been a violation of federal law. Bert Rein, lead outside attorney for Wyeth, said, “It would be a chaotic system if you can relabel anything as long as you mumble safety.” However, Rein said he did not know of any instances where FDA had punished a firm for increasing the emphasis of a warning label.

Levine’s lawyers say federal law is not intended to prevent drugmakers from taking proactive steps to enhance warnings to doctors and consumers. According to the Journal, they say FDA guidelines “are the floor, not the ceiling, when it comes to safety standards.”

Consumer advocates say patients’ ability to sue in state courts is their only defense against corporate misbehavior, such as instances where FDA reviewers make a mistake or firms hide information. The New England Journal of Medicine in August published an editorial in favor of Levine that made similar arguments. Rein said that a ruling in favor of pre-emption would make it more difficult for people harmed by drugs to obtain compensation, but noted that Congress should establish a fund for such patients, as it did for vaccine-related injuries.

Implications

According to the Journal, a ruling in favor of pre-emption could heavily affect the drug industry. Recent cases that would have been affected include a $68 million settlement by Johnson & Johnson over its Ortho Evra contraceptive patch, more than $1 billion in settlements by Eli Lilly over its antipsychotic drug Zyprexa and $4 billion in payments so far by Merck over lawsuits involving its anti-cholesterol treatment Vioxx.

The Journal reports that some Democrats said that if they increase their majority in Congress this election cycle they will propose bills to undo pre-emption and guarantee the ability of patients to sue for damages (Wall Street Journal, 10/27).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

Addressing Questions About Gardasil

On this page:

• What is Gardasil?
• Why is Gardasil needed?
• Is Gardasil safe?
• Why have questions been raised about the vaccine’s safety?
• Should these reports worry me?
• What non-serious problems have been reported?
• What are FDA and CDC doing about the concerns?
• How is Gardasil’s safety being monitored?

Recently, questions have been raised about the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.

What is Gardasil?

Gardasil is a vaccine for use in girls and women 9 through 26 years of age. It is approved for preventing cancer of the cervix, vulva and vagina, and for preventing genital warts caused by the types of HPV contained in the vaccine.

These four HPV types (6, 11, 16, and 18) cause about 70% of cervical cancers and about 90% of genital warts. They are also known to cause some vulvar and vaginal cancers. (Percentages related to these conditions are not well defined.)

back to top

Why is Gardasil needed?

Gardasil may benefit the health of millions of people. Each year, more than 12,000 American women are diagnosed with cervical cancer, and almost 4,000 women die from this disease. In addition, about 6.2 million Americans become infected with genital HPV each year. Worldwide, cervical cancer is the second most common cancer in women, with 233,000 deaths per year.

back to top

Is Gardasil safe?

Based on ongoing assessments of vaccine safety information, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to find that Gardasil is a safe and effective vaccine.

Studies involving approximately 21,000 girls and women in the United States and worldwide were conducted to evaluate the safety and effectiveness of Gardasil before the vaccine was approved by FDA. Approximately half of the study participants received Gardasil, and the other half received a control.

back to top

Why have questions been raised about the vaccine’s safety?

There have been reports of serious adverse events in girls and women that have received the vaccine. These include death and Guillain-Barre Syndrome (GBS), a rare neurological disorder that causes muscle weakness.

back to top

Should these reports worry me?

Based on the review and assessment of vaccine safety information available, FDA and CDC continue to find that the benefits of Gardasil outweigh the risks.

Twenty deaths had been reported to the FDA- and CDC-administered Vaccine Adverse Event Reporting System (VAERS) as of June 30, 2008, in women that received Gardasil.

However, no common pattern to these deaths has been detected that would suggest they were caused by the vaccine. In cases where autopsy, death certificate, and medical records were available, the cause of death was explained by factors other than the vaccine.

Given the large number of vaccine doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in a large population during the time period following vaccinations.

The manufacturer, Merck and Co., has distributed more than 16 million doses of Gardasil nationwide. As of June 30, there were 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events.

Also, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity, and potency of Gardasil.

back to top

What non-serious problems have been reported?

• Syncope (Fainting)
• Pain at the injection site
• Headache
• Nausea
• Fever

Fainting, which may sometimes cause serious injuries from falling, is common after injections and vaccinations, especially in adolescents. FDA and CDC have reminded health care professionals that women receiving Gardasil should be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine’s prescribing information includes this as well.

back to top

What are FDA and CDC doing about the concerns?

FDA and CDC take all concerns about vaccine safety seriously, and, as they do with all licensed vaccines, will continue to closely monitor Gardasil’s safety.

Because available information indicates that Gardasil continues to be safe and effective, and that its benefits continue to outweigh its risks:

• CDC has not changed its recommendations for use of Gardasil.
• FDA has not made any changes to the Warnings or Precautions sections in the vaccine’s prescribing information related to safety.

back to top

How is Gardasil’s safety being monitored?

• FDA and CDC closely monitor the safety of all vaccines through VAERS, which receives unconfirmed reports of possible side effects following the use of vaccines licensed in the United States.
• Each batch (known as a “lot”) of Gardasil is manufactured and tested for quality control according to the requirements of its FDA license. FDA verifies this, as it does with other vaccines, by performing a lot-by-lot batch review process.
• FDA’s review assures the appropriateness of manufacturing processes and confirmation of testing results. It also includes regular unannounced on-site inspections.
• No batch may be released for distribution until it has successfully completed all testing and review requirements.
• FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.

CDC also has other systems in place to monitor the safety of all licensed vaccines.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

back to top

For More Information

CDC and FDA Information on Gardasil’s Safety

www.fda.gov/cber/safety/gardasil071408.htm

Vaccine Adverse Event Reporting System (VAERS) Web site

www.vaers.hhs.gov

FDA Press Release (Sept. 12, 2008):

Approval of Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html

back to top

Date Posted: September 29, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

“In television advertisements, a cast of hip people in their 20s — artists, writers and professionals — describe why they got the shots, in the language of liberation, such as, “I chose to get vaccinated because my dreams don’t include cervical cancer.” The advertisements direct viewers to gardasil.com, which includes patients’ stories, buddy icons and downloads for holding an event at sororities.

Girls of any age who have had one dose of the vaccine can ask for text-message “reminders” from Merck to get the next two shots. The offers come with another reminder: “I understand that the information I provide will be used by Merck or those working on behalf of Merck for market research purposes.”

For such efforts, Merck last May swept the 2008 Pharmaceutical Advertising and Marketing Excellence awards, and Gardasil was named Brand of the Year by Pharmaceutical Executive magazine.

The marketing helped make Gardasil one of Merck’s best sellers, with a projected sales of $1.4 billion to $1.6 billion outside Europe this year, and more from sales in Europe, where Merck sells the vaccine through a joint venture with Sanofi Aventis.

Aggressive pharmaceutical advertising is nothing new, but the campaign was a revolution for a vaccine. Vaccines were traditionally the orphans of the pharmaceutical world because they were cheap and not particularly profitable. But the two for cervical cancer are the latest in a wave of high-priced vaccines that have come to market since 2001, opening a lucrative new field.”

Excerpted from:: THE EVIDENCE GAP; Drug Makers’ Push Leads to Cancer Vaccines’ Rise

August 20, 2008 – By ELISABETH ROSENTHAL (NYT) – Front Page –

… DRUG MAKERS’ BIG PUSH A marketing campaign in the United States and Europe by Merck has made Gardasil, its cervical cancer vaccine, a best seller. Cervarix, a similar vaccine from GlaxoSmithKline, has also proved popular, and profitable.

Read the full article and send the link out to anyone who cares about the health issues of women and girls!

Inconvenient Women do not get angry…We get ACTIVE!!

The marketeer/lobbyist/legislator ‘hook-up’ only works if no one is looking. Make sure your representatives know you are watching them and are holding them accountable for the health and wellfare of the nations’ women and girls.

©2012 An Inconvenient Woman. All Rights Reserved.