FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Johnson and Johnson–Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants’ Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments

Media Contact:

Marc Boston

215-273-7649 (office)

215-429-7034 (mobile)

Bonnie Jacobs

215-273-8994  (office)

856-912-9965 (mobile)

FOR IMMEDIATE RELEASE — Fort Washington, PA (November 7, 2008) – Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants’ MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.

Infants’ MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants’ MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants’ MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: Use postage-paid FDA form 3500 available at:

www.fda.gov/MedWatch/getforms.htm.

Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

©2012 An Inconvenient Woman. All Rights Reserved.

In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA approval; which in our opinion precluded a reasonable amount of time to follow-up for adverse reaction to the injection.

The RUSH-TO-APPROVAL, combined with MERCK’s, MEGA-Money State and Federal legislative-lobbying efforts, made us very nervous. Anytime a State or Federal agency mandates the use of a vaccine, the manufacturer is essentially, held harmless. That means adverse reaction victims cannot sue them directly. MERCK gets hide behind the shield of the very government agencies WE pay to protect us.

In our articles, Leslie and I cited European researchers who questioned not only the efficacy of the HPV vaccination plan, but the cost effectiveness of what could be one of the largest transfers of public money to private industry in history. With early detection, cervical cancer can be successfully treated; and the best early detection tool is the inexpensive, easily attainable PAP test.

“In developed countries, Pap smear screening and treatment have effectively reduced cervical cancer death rates to very low levels already. There are 3,600 deaths annually from cervical cancer in the United States, 1,000 in France and 400 in Britain.”

Each of those women were mothers, daughters and sisters, and very dear to their families. Most of the deaths were a result of lack of access to preventive medical care. The poor and uninsured can’t get a $30 PAP test, but our public heath officials think its justifiable to mandate BILLIONS of dollars to inoculate young girls with a vaccine that could do more harm than good.

MERCK has sold $1.5 BILLION worth of Gardasil® vaccine in less than two years. Those Gardasil® sales are saving their Vioxx-ravaged balance sheet. How many PAP tests would that amount provide women who have limited, or no, access to preventative care? If the safety of young girls doesn’t make you want to take action and stop this madness, how about cost-effect, use of limited health care resources?

Breast cancer kills hundreds of thousands of women every year…and the numbers are rising. Would 1.5 BILLION dollars be better spent on breast cancer research? We think so.

Spending 1.5 billion on Gardasil®, chasing the ghost of “possible cancer” in the distant future, is not good stewardship of time, talent and treasure — unless you own MERCK stock.

Two years ago Leslie and I sent information to major media outlets, asking that they at least investigate the possibility that HPV vaccines might not be effective or safe for young girls.

We felt like the mythical Cassandra…no one was interested in the news.

To date, there have been 17-deaths and thousands of reported hospitalizations of previously healthy young women and girls. As adverse reactions started to be recorded to the NVIC database, investigative reporters began questioning the HPV vaccine’s safety and cost-effectiveness. Harvard just published a “Follow the Money” report delineating the cost benefit of the mostly, publicly, funded HPV-vaccination initiative.

In the fall of 2006, using published US census data, Leslie and I estimated the number of targeted girls and women (nine to twenty-six year old) and the reported cost of the series of three of the Gardasil® inoculation and estimated the cost to public health budgets. I was sure some bean counter in the bowls of MERCK had preformed the same calculations, with far better resources, when determining the Lobbying budget that got Gardasil® approved.

I wish I could say, we are please to report that with about 20-hrs work, an old calculator and a new MAC laptop we came within a $60K of the Harvard study; but it is actually kind of depressing. All it proves is that we need more inconvenient women, asking more questions, more often, with greater insistence.

Excerpt of Harvard Study

“The vaccines, which require three shots for a complete series, cost about $400 to about $1,000, depending on the country and the fees for doctors’ visits. Unlike older vaccines that save money by preventing costly disease, these vaccines cost health systems money.

The Harvard study concluded that giving the vaccine to 12-year-olds would cost $43,600 for every “quality adjusted year of life” it saved by preventing a cancer death; that price would often be considered acceptable by health officials in wealthy countries, experts say.

But if the vaccine were given to all girls and women up to age 21, the cost per year of life saved would be far higher — $120,400, the Harvard study concluded. And if the vaccines prove to require a booster shot, as many critics believe, that cost rises to $140,000. In such cases it might make more economic sense to rely on Pap smear screening alone, the researchers said.”

Read the full text of following NY Times article.

Email the links to as many women, and health professions as you can.

Inconvenient Women take ACTION!

Click here for the full ELISABETH ROSENTHAL’s NY Times article on Gardasil®, Published: August 20, 2008

“Two vaccines against cervical cancer are being widely used without sufficient evidence about whether they are worth their high cost or even whether they will effectively stop women from getting the disease, two articles in this week’s New England Journal of Medicine conclude.”

“The two vaccines, Gardasil by Merck Sharp & Dohme and Cervarix by GlaxoSmithKline, target two strains of the virus that together cause an estimated 70 percent of cervical cancers. Gardasil also prevents infection with two other strains that cause some proportion of genital warts. Both vaccines have become quick best sellers since they were licensed two years ago in the United States and Europe, given to tens of millions of girls and women.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” Dr. Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, wrote in an editorial in Thursday’s issue of The New England Journal. “With so many essential questions still unanswered, there is good reason to be cautious.”

In her article, Dr. Haug points out the vaccines have been studied for a relatively short period — both were licensed in 2006 and have been studied in clinical trails for at most six and a half years. Researchers have not yet demonstrated how long the immunity will last, or whether eliminating some strains of cancer-causing virus will decrease the body’s natural immunity to other strains.

More to the point, because cervical cancer develops only after years of chronic infection with HPV, Dr. Haug said there was not yet absolute proof that protection against these two strains of the virus would ultimately reduce rates of cervical cancer — although in theory it should do so.

Both vaccines target the human papillomavirus, a common sexually transmitted virus that usually causes no symptoms and is cleared by the immune system, but which can in very rare cases become chronic and cause cervical cancer”

For more information read:

The Evidence Gap: Drug Makers’ Push Leads to Cancer Vaccines’ Rise (August 20, 2008)

Send these links out to anyone who cares about the health issues of women and girls!

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

©2012 An Inconvenient Woman. All Rights Reserved.

I was doing some research for a fiend whose child had just been “diagnosed” Deficit Hyperactivity Disorder (ADHD) by a school nurse who suggested drug therapy. My first thought was a Kindergarten version of ‘One Flew Over the Cuckoo’s Nest’…dazed and compliant preschoolers.

In the past decade, ADHD, ”Deficit Hyperactivity Disorder, a neurobehavioral developmental disorder has become one of the most commonly diagnosed conditions of childhood, and is being increasingly diagnosed in adults. ADHD is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility. The pharmaceutical medical industrial complex currently considers ADHD a “persistent and chronic condition for which no medical cure is available. Methods of treatment usually involve some combination of medications, behavior modifications, life style changes, and counseling. (BTW side effects aside, MEDICAL TREATMENT is spelled with two-cha-chings!)

So how do most ‘school nurses’, Physicians’ assistants and doctors come up with the very common ADHD diagnosis? Most medical professions use the “Desk Reference to the Diagnostic Criteria From DSM-IV-TR®”, compiled by American Psychiatric Association. Available in a spiral-bound book, and online accessible by computer, or PDA, the diagnostic criteria from DSM-IV-TR® is one of the most commonly used tools used by Physicians and other “prescribing” health care professions. Another ‘tool’, Desk Reference (PDR), which includes every prescription drug package insert. The guides serve as ‘medical cliff notes’, listing symptoms, probably diagnosis, suggested drug protocols, prescription drug side effect information and possible drug interactions.

Guidelines issued by the American Academy of Pediatrics recommend medications like CONCERTA® among first-line therapies for children with ADHD as part of a comprehensive treatment program. Go to the CONCERTA® website(1), READ the SIDE EFFECTS.

What rational person would suggest a little kid’s developing brain be put at risk, to assure social compliance? I knew there had to be a better way to deal with “the fidgets” so I did what Inconvenient Women do best, I looked stuff up, and sent the results out to a few thousand of my closets friends.

In September of 2007, William Atkins did a brillant, if little noted, piece on hyperactivity in children. I found it on IWIRE one of my favorite obscure resource sources. For the full article go to: http://www.itwire.com/content/view/14399/1066/

Study links hyper kids with artificial preservatives and colorings

Sodium benzoate and other food preservatives and colorings have been linked with hyperactivity in children. Although such ingredients have been thought in the past to produce adverse behavior in children, this study is considered the first scientific evidence of its kind.

The British study from researchers at the University of Southampton, England, has found that the food preservative sodium benzoate (also called benzoate of soda, with chemical formula C₆H₅COONa), when found with food dyes and colorings, can increase hyperactive behavior in children. Jim Stevenson, psychologist at the University of Southampton, and lead researcher of the study states, “We now have clear evidence that mixtures of certain food colors and benzoate preservative can adversely influence the behavior of children. We have now shown that for a large group of children in the general population, consumption of certain mixtures of artificial food colors and benzoate preservative can influence their hyperactive behavior.”

Food colorings and preservatives–which are often found in sweets such as ice cream, candy, and soda, what children love to eat–were studied. For six weeks over one hundred fifty randomly three-year-olds and over one hundred forty randomly eight-year-olds, in Southampton, England, were studied as to their diet.

The children displayed behaviors previous to the study ranging from normal to hyperactive.

They were provided food that was free of additives. Each day they were given one drink, either fruit juice or one of two mixtures of sodium benzoate preservative and food colorings. One mixture contained sodium benzoate and sunset yellow, tartrazine, carmoisine, and ponceau. The other mixture contained sunset yellow quinoline yellow, carmoisine, and allura red. They were not told which they were given, the fruit juice or one of the two mixtures.

The children who were given the benzoate preservative and food coloring mixtures showed, in some cases, more hyperactive behavior than the children given fruit juice. However, the increases in hyperactive behavior were not consistent between the two mixtures. The researchers contend that the hyperactive behavior may be linked to sodium benzoate and one or more of the specific artificial colorings, rather than to all of the colorings.

The U.S.$1.5 million study was funded by the British Food Standards Agency (FSA) and written up on September 6, 2007, in the journal The Lancet.

From the website of the Food Standards Agency comes this advise, “Parents of children showing signs of hyperactivity are being advised that cutting certain artificial colours from their diets might have some beneficial effects. The colours – Sunset yellow (E110), Quinoline yellow (E104), Carmoisine (E122), Allura red (E129), Tartrazine (E102) Ponceau 4R (E124), and Sodium benzonate (E211) – were studied as part of new FSA-commissioned research.”

Within the Friday, September 7, 2007, FSA article “Agency revises advice on certain artificial colours”, Andrew Wadge, the FSA’s Chief Scientist, said: “This study is a helpful additional contribution to our knowledge of the possible effects of artificial food colours on children’s behaviour.”

“After considering the COT’s [Committee on Toxicity (COT)] opinion on the research findings we have revised our advice to consumers: if a child shows signs of hyperactivity or Attention Deficit Hyperactivity Disorder (ADHD) then eliminating the colours used in the Southampton study from their diet might have some beneficial effects.”

“However, we need to remember that there are many factors associated with hyperactive behaviour in children. These are thought to include genetic factors, being born prematurely, or environment and upbringing.”

“The Agency has shared these research findings with the European Food Safety Authority (EFSA), which is currently conducting a review of the safety of all food colours that are approved for use in the European Union, at the request of the European Commission. This review is being undertaken because of the amount of time that has elapsed since these colours were first evaluated.”

“If parents are concerned about any additives they should remember that, by law, food additives must be listed on the label so they can make the choice to avoid the product if they want to.”

[William Atkins' note: When buying foods, always LOOK at the labels. What you don’t read may hurt you and your loved ones when you consume such foods.]

Inconvenient Women take action. If you know a mom who is drugging their child at the suggestion of a school nurse or family doctor, ask her to take this or other nutritional research to them and at least try to change their child’s diet before resorting to the BIG PHARM option.

If the child is a little girl, get her to a female pediatrician, specializing in precocious puberty. Girls as young as four and five years old are experiencing what their moms dealt with at twelve and thirteen. (See precocious puberty in IconicWoman article archive and go to: http://www.HolyHormones.com)

Explore every option before “medicating” compliant behavior.

(1) CONCERTA® and OROS® are registered trademarks of ALZA Corporation

This site and its contents are intended for USA audiences only.

©2012 An Inconvenient Woman. All Rights Reserved.

 Reported by Barbara Loe Fisher

The reports of HPV vaccine reactions, injuries and deaths continue to roll in, not only to NVIC but also to the federal Vaccine Adverse Events Reporting System (Search HPV4 at: http://www.medalerts.org/vaersdb/index.html) newspapers, and television stations.

And the only response that comes from officials at the CDC, FDA and drug companies when perfectly healthy teenage girls collapse into unconsciousness, suffer a massive seizure, get paralyzed or die suddenly after being injected with GARDASIL is the buracratic mantra: “It is a coincidence.”

“I just kept thinking about the good outcomes rather than what could actually happen.” What happened to Crystal Olivera was arm pain so severe that it left her unconscious immediately after a Gardasil shot, something she had never experienced with her hepatitis and meningitis vaccines. “The next thing I know I am on the floor in the fetal position.” Had she known more about Gardasil – “I wish I’d waited a little until it was out in the public more and also that they did more research about the negative side effects.” – Jamie Colby, Fox News (July 11, 2008) SEE VIDEO at http://www.foxnews.com/video2/video08.html?maven_referralObject=2233990&maven_referralPlayli

stId=&sRevUrl=http://www.foxnews.com/health/index.ht ml

“Jessica Ericzon, 17, was “an all- American teenager,” as described by one of her upstate LaFargeville teachers. Last February, she was working on her softball pitches, getting ready for a class trip to Universal Studios in Florida and hitting the slopes to snowboard with her older brother. Then one day, the blond, blue-eyed honors student collapsed dead in her bathroom. It started with a pain in the back of her head. On the advice of her family doctor, Jessie had taken a series of three Gardasil shots. The vaccine, marketed for females ages 9 to 26, is the first found to ward off strains of the sexually transmitted human papillomavirus, or HPV, which can cause cervical cancer. Jessie got the first injection in July 2007. After her second shot in September, she complained of a pain in the back of her head, fatigue and soreness in some joints, said her mom, Lisa. On Feb. 20, while on winter break from school, she got her third and final dose of the vaccine. The next night, “she told me the spot on the back of her head was bothering her again,” her mom said. The next morning, Feb. 22, Lisa, a hospital technician, left for work just after 5 a.m., leaving Jessie asleep. Jessie never showed up for the class she was taking at Jefferson Community College. When her mom got home at 3:20 p.m., she found Jessie sprawled on her back on the bathroom floor, with blood spots on her head where it had hit a flowerpot. Jefferson County Medical Examiner Samuel Livingstone is stumped. “She was essentially dead by the time she hit the floor. Whatever it was, it was instantaneous,” Livingstone said. His autopsy found no cause.” – Susan Edelman, New York Post (July 20, 2008)

http://www.nypost.com/seven/07202008/news/regionalnews/my_girl_died_as_guinea_pig_for_gardasil_120737.htm

” Katherine Kimzey got her first injection of Gardasil along with a Hepatitis-A vaccine and a chicken pox booster. She got the second injection two months later, along with the D-TaP vaccination. Six weeks after the second injection of Gardasil, Katherine passed out. “I tried to get up and my neck was stiff, and I couldn’t move it,” the teenager explained. “I couldn’t move at all.” Katherine spent five days in the hospital.

Shannon Nelson, 18, from the Chicago area, got the Gardasil shot and two other vaccines– at the same time. Within a week the soccer star could barely move. “When I went into the hospital I couldn’t walk at all. I had to have a wheelchair. It just got worse each day,” she explained. Nelson spent 23 days in the hospital and while she’s better now the teenager believes one of the vaccines she received is responsible for her illness and her neurologist says it’s certainly possible.

Katherine Kimzey is back on the soccer field in North Texas. But she still has occasional pain and doesn’t know what the future will hold. Thinking about her past experience she says she still worries and so does her mom. Michelle Kimzey says next time; she won’t be so quick to jump on the new vaccine bandwagon. “I think the connection is huge,” she said.

In a statement to CBS 11 News, Merck — the maker of Gardasil — said it has analyzed the reports of paralysis and death, and believes: no safety issue related to the vaccine has been identified.” – Ginger Allen, CBS News 11 – Dallas (July 21, 2008) http://cbs11tv.com/health/Gardasil.cervical.cancer.2.776277.html

“Consumer concerns over safety have not been assuaged by “reassurances from the government,” said Barbara Loe Fisher, cofounder of the National Vaccine Information Center (NVIC). “We have heard reassurances about safety before – for example, with the whole-cell pertussis (diphtheria- pertussis-tetanus [DPT]) vaccine in the 1980s,” she said, noting that this was subsequently withdrawn and replaced by an acellular version in the United States in the 1990s. Ms. Fisher has a son whom she believes was damaged by the DPT vaccine 28 years ago, and she has worked ever since as an activist in the vaccine safety field in various capacities, including a 4-year stint as a consumer member of the FDA Vaccines and Related Biological Products Advisory Committee.

In addition, the NVIC has been running its own private vaccine reaction registry for the past 26-years, and it currently has about 140 reports on Gardasil, Ms. Fisher said. “These include reports of injury and death, and we are seeing a pattern of what we have termed ‘atypical collapse,’ ” she commented. “These include cases where a girl suddenly passes into unconsciousness either immediately or within 24 hours of vaccination and then revives feeling weak and unable to speak properly or exhibiting other neurological signs. What we are concerned about is that girls are not aware of this possibility and could be crossing the road or driving a car and suddenly pass out.” Ms. Fisher also outlined concerns about how Gardasil has been studied. She pointed out that very few of the participants in the clinical trials were aged 11 to 12 years, which is the recommended target age for the vaccine. The New York Times reported in 2006 that of the 20,000 trial participants, 1200 were younger than 16 years.” – Zosia Chustecka, Medscape Medical News (August 8, 2008) http://www.medscape.com/viewarticle/578110

Sources:

http:://www.vaccineawakening.blogspot.com

http://www.NVIC.org

http://www.StandUpBeCounted.org

©2012 An Inconvenient Woman. All Rights Reserved.

The Food and Drug Administration (FDA) is warning people not to use or buy Mommy’s Bliss Nipple Cream because the product contains potentially harmful ingredients that may cause respiratory problems or vomiting and diarrhea in infants.

Marketed by MOM Enterprises Inc. in San Rafael, Calif., the product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. The product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, FDA is alerting the public because of the potential harm this product could have on nursing infants. To date, no injuries to infants have been reported to FDA.

Potentially Harmful Ingredients

The two potentially harmful ingredients in Mommy’s Bliss Nipple Cream are chlorphenesin and phenoxyethanol, which may interact with one another to further increase the risk of slow or shallow breathing (respiratory depression) in nursing infants.

Chlorphenesin

• relaxes skeletal muscle
• can depress the central nervous system and cause respiratory depression in infants
• can cause a skin condition that can worsen the drying and cracking of nipple skin (dermatitis) in mothers

Phenoxyethanol

• is a preservative that is primarily used in cosmetics and medications
• can depress the central nervous system
• may cause vomiting and diarrhea, which can lead to dehydration in infants

Signs to Watch For

Get immediate medical attention if your child is showing the following signs and symptoms or if you are having difficulty awakening the child:

• decrease in appetite
• limpness of extremities or decrease in strength of grip and
• a change in skin color

What Consumers Should Do

• Discontinue use of Mommy’s Bliss Nipple Cream.
• Consult a health care professional if you experience problems or believe your infant may have experienced problems due to the product.
• Speak with your health care professional or certified lactation consultant if your nipples are cracked or painful.
• Report adverse events related to the product to MedWatch at www.fda.gov/medwatch/report.htm or by calling 800-332-1088.

For More Information

FDA Press Release

www.fda.gov/bbs/topics/NEWS/2008/NEW01839.html

FDA MedWatch Web site

www.fda.gov/medwatch/

Date Posted: May 30, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

The Wall Street Journal on Monday examined the efficacy of Merck’s  human papillomavirus vaccine Gardasil  in treating precancerous lesions and preventing cervical cancer (Carreyrou, Wall Street Journal, 4/16). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with strains 16 and 18, which together cause about 70% of cervical cancer cases, and about 99% effective in preventing HPV strains 6 and 11, which together with strains 16 and 18 cause about 90% of genital wart cases, among women not already infected with these strains. FDA in July 2006 approved  Gardasil for sale and marketing to girls and women ages nine to 26, and CDC’s Advisory Committee on Immunization Practices  later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women’s Health Policy Report,  4/5). According to the Journal, the vaccine has been “dogged by uncertainty” about “how effective it really is.” In clinical trials, 361 of 8,817 women who received at least one shot of Gardasil developed precancerous lesions on their cervixes within three years of vaccinations, only 14% fewer than women in a placebo group, the Journal reports. Merck has said the 14% figure is misleading because more than 25% of the women in the study were already infected with HPV before receiving the vaccine. In a subset of 4,616 women in the trial who were mostly free of HPV when they were vaccinated, only 52 developed precancerous lesions on their cervixes over the next three years, 46% less than women in the placebo group, according to the company. According to the Journal, the efficacy of the drug in preventing lesions is a “significant issue” because if a Pap test shows lesions, physicians will usually remove any that are seen as serious.

Additional Comments

While Merck has said that Gardasil prevents infection with the two strains that cause 70% of cervical cancer cases in women not already infected with those strains, Eliav Barr, head of Merck’s HPV vaccine program, said Gardasil’s true efficacy will become more apparent with time, especially in the group that includes women with a pre-existing infection. Barr said that the vaccine is less than 70% effective in preventing precancerous lesions but adds that it will eventually be shown to prevent nearly 60% of the lesions doctors would want to remove. Scott Emerson, a professor of biostatistics at the University of Washington  who sat on the FDA advisory panel that recommended approval of Gardasil, said he is not convinced that the vaccine is worth the billions of dollars likely to be spent on it in the coming years. “I do believe that Gardasil protects against HPV 16 and 18, but the effect it will have on cervical cancer rates in this country is another question entirely,” Emerson said, adding, “It’s almost the treating the symptom but not the disease sort of idea” (Wall Street Journal, 4/16).

“Reprinted with 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 . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Gardasil

©2012 An Inconvenient Woman. All Rights Reserved.