This weekend, while I was doing some additional research for our next book, Gardasil — The Hidden Truth, I found a previously undisclosed 1987 filmed interview of Merck’s chief vaccine researcher and the “Father” of modern childhood vaccines, the late Dr Maurice Hilleman. The internationally renowned vaccinologist, was for many years,  Merck’s Vaccine Division Chief.  This stunning footage features medical historian Edward Shorter interviewing Hilleman for WGBH public television (Boston) and Blackwell Science. The interview was cut from The Health Century program due to the potential liability — the tacit admission that Hilleman, through a Merck vaccine program, introduced the HIV virus and AIDS to the modern world.

I found the comments and attitudes of both Dr. Maurice Hilleman and Edward Shorter so over-the-top-callous, I initially suspected the video to be a hoax; however, the authenticity has been verified by the Alliance for Human Research Protection (AHRP).  Additional research verified that the interview was indeed conducted by Dr. Edward Shorter, Professor of the History of Medicine and Professor of Psychiatry, University of Toronto. Dr. Shorter has on numerous occasions since the clip’s release, confirmed the authenticity of the tape and has verified in print that he conducted the interview when preparing a PBS series called “The Health Century.” Doubleday published a companion volume of the same title in 1987. Dr. Shorter deposited the entire tape of the interview, including portions omitted from the book, along with other interviews in the National Library of Medicine. The video clip is now posted on “YouTube.”

This interview was taped with several Merck executives in the room. It is their laughter audible in the tape. Dr. Hilleman explains how in his search for uninfected monkeys; Merck imported green monkeys from Africa. Those monkeys, it turned out, were carrying the HIV virus: “I didn’t know we were importing AIDS.”

In a separate admission, Dr. Hilleman acknowledged that he discovered that the Sabine polio vaccine (manufactured by Merck) was infected with the SV-40 cancer virus. In the process of developing vaccines Merck scientists are shown to exhibit a corporate culture of blatant disregard for public safety as they conducted massive tests exposing millions of unsuspecting people to wild viruses. Dr. Hilleman acknowledged that the cancer infected polio vaccine had been tested in massive field trials in Russia, then in the States.

The issues discussed in this candid interview raise serious doubts about the propaganda the public has been fed about the safety of Merck vaccines. Vaccines that have been promoted as “safe and effective” miraculous cures have been infecting (possibly) millions of people with cancer, leukemia, and AIDS.

The latest Merck ‘Miracle Vaccine” to be foisted on the young women of the world is GARDASIL®. More marketing miracle than reliably tested science, this HPV vaccine has been pushed in to the market place with the help of the Fast Track FDA approval program, a CDC endorsement and the greased palms of untold numbers of venial Federal and State representatives.

Gardasil® is a vaccine that defies justification.

Cervical cancer is a slow developing, highly detectable and ‘curable’ cancer. Widespread access to the PAP test and safe ‘in-office” treatment has almost irradiated cervical cancer as a ‘mortal threat’ in developed countries. Less than 4,000 women die from cervical cancer each year in America… and those precious mothers, daughters, sisters and aunts could have been saved with better access to community public health facilities for PAP screening and needed follow-up treatment.

As for the ‘dreaded HPV threat’ — HPV is amongst the most common viruses found in humans — so common they were once considered a ‘marker’ for sexual activity.  Most researchers agree, a healthy, well-nourished human body, usually resolves HPV over a period of months or years.   Statistically, cervical cancer usually appears in middle-aged women.  Due to the FDA Fast Track approval process, there is no long-term Gardasil® clinical trial data that indicates how many years the vaccine will “protect’ a woman from opportunistic HPV infection.  In its own literature Merck advises women to continue their scheduled PAP tests.

If women still need to rely on PAP tests to “Guard” against cervical cancer — why should we be injected with the unproven vaccine Gardasil®?

How many girls will have to die or suffer injury as a result of the Gardasil® vaccine before our officials move to protect our genetic future?

Our current government Gardasil® policy simply makes no sense.

When the US Treasury is printing money like a failed banana republic, why are we involved in one of the largest transfers of public money into private hands in our history? The cost of Gardasil® will expand far beyond the ridiculously expensive vaccine, to include the health care costs for the young women who are being stricken with numerous, life-changing side-effects. These recently uncovered facts about Merck’s corporate culture of producing unsafe vaccines should prompt a reexamination of the advisability of our Gardasil® vaccine policies. We need to work together to get this vaccine off the market now! Under no circumstances should this vaccine be expanded to include young men.

Be Inconvenient Women. Write your representatives demanding that they step up and protect our children.

Please forward this Blog and video link,
http://www.youtube.com/watch?v=vgBBwOnmy3w to everyone you know who still thinks all vaccines are “safe and effective” and the Government is here to protect them...

Bless their hearts.

©2012 An Inconvenient Woman. All Rights Reserved.

As Glaxo is forced to wait for FDA’s approval for its own HPV vaccine, Cervarix, will the company use its time on the sidelines to absorb lessons learned from Merck’s missteps? There is a building backlash against Merck’s ‘BIG-FOOT’, political lobbing strategy that aggressively pushes politicians to mandate its vaccine. Merck has pushed through from one political firestorm to the next. An increasing resentful public is feeling like Atlanta to Merck’s Sherman-like march to market share.

Preparing for its FDA review, Glaxo tested the Cervarix vaccine on nearly 30,000 girls and women, ranging in age from 10 to 55 years old. An effectiveness trial involved 18,000 girls and women between 15 and 25 years old.

Independent medical researchers and financial analysts believe Glaxo’s Cervarix will have a slight edge over the Gardasil product. However, given how Merck has muddied the waters with political controversy and been accused of predatory marketing, the Cervarix HPV-vaccine will draw more scrutiny.

Once Cervarix wins FDA approval, the real question is; Will Glaxo be tempted to follow the Merck marketing model? Or will the Glaxo rollout team let the product’s efficacy speak for itself?

©2012 An Inconvenient Woman. All Rights Reserved.

In the early 1990s, faced with protests by AIDS activists about the glacier-like approval of potential life saving drugs, the Clinton administration changed the FDA drug approval process. They allowed pharmaceutical companies to “fast track life-saving” drugs by absorbing the extra costs involved. The unintended consequence of this humanitarian intention became “Safety for Sale”. The number of product recalls in the past 15-years is enough to turn the most trusting advocate of governmental infallibility into a stone, cold, cynic.

Successive administrations have unsuccessfully struggled with more than one “Drug-War”. If the American public were truly aware of the actual body count that has resulted from BIG PHARMA’s policy of ‘profit over accountability’, they would be marching in the streets. Maybe the people who demanded the networks show the flag draped coffins of fallen soldiers, so the public would become more aware of the very human cost of war, had the right idea.

The young people who have lost their lives to unsafe, questionably tested, and hastily approved drugs, died without the notice of the national media…one heart-wrenching loss at a time. The bereaved families stand alone at the gravesite; go back to an empty house, and sit in the silence of dreams forever unlived.  Since the beginning of the wars in Afghanistan and Iraq, America has lost more young men and women to fatal adverse medical events than to enemy hostilities.

Maybe the Gardasil® mothers, and the parents of the teens on antidepressants who committed suicide or the parents of kids who were killed by other kids in the grip of drug-induced paranoia, could stand together with the pictures of the children they have lost. It is time to make the country aware of how the ‘profit before safety’ paradigm of BIG PHARMA and its unholy alliance with our erstwhile, ineffective, protector, the FDA, is costing lives and ripping the fabric of the families left behind to grieve and wonder why and what could have been.

Independent journalist, Cynthia Janak, has made a start. She has developed a web site memorial to those young women and girls who have lost their lives to Gardasil®. The site also features stories of the young women who survived, forever changed, by an adverse reaction to the Gardasil® vaccine. Cynthia is taking action. She is giving a voice to the women, who have been beneath the notice of the national media. Cynthia has chosen to stand up, speak out and be a witness.

In the bastions of big money and BIG PHARMA, I’m sure Cynthia is considered a very INCONVENIENT WOMAN indeed.
Please visit http://www.cynthiajanak.com/Gardasil.html and Remember The Names and The Faces of the girls who died for greed and Gardasil®.

©2012 An Inconvenient Woman. All Rights Reserved.

This weekend The Philadelphia Inquirer examined how Sen. Chuck Grassley (R-Iowa) has “found a congressional calling” in “creating uproars that often transform public opinion and policy” and “in recent years … has repeatedly turned his sights on wrongdoing by the pharmaceutical industry and its overseer,” FDA. Grassley held Senate hearings that contributed to the decision by Merck to withdraw the COX-2 inhibitor Vioxx from the market in 2004, and his “revelations about prominent psychiatrists who failed to disclose large payments from drug companies have fueled investigations into conflicts of interest,” according to the Inquirer. In addition, research conducted by his staff in 2007 found that GlaxoSmithKline allegedly “bullied” scientists who identified heart problems associated with the diabetes medication Avandia, the Inquirer reports.

According to the Inquirer, his “doggedness has won him praise,” but “some experts warn that Grassley has oversimplified challenging science.” However, Grassley believes that he is “simply providing a forum for competing scientific ideas, not deciding which ones prevail,” and that the legislation he has proposed is “aimed at bringing more information into the open,” the Inquirer reports (Hill [1], Philadelphia Inquirer, 2/8).

For those of us who want more transparency in the Big Phama Lobby/FDA Approval process, a note of thanks to both Representative Grassley and to the Philadelphia Inquirer editorial staff would be a good thing.

Source Documentation: Philadelphia Inquirer, 02.11.2009
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.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

©2012 An Inconvenient Woman. All Rights Reserved.

Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine.

The Food and Drug Administration recently announced a public Web site listing potential drug side effects it is investigating. This move does seem to be in the public interest; after all, shouldn’t we know about drug side effects that are concerning enough to warrant an FDA investigation?

On further reflection, this turns out to be a pretty complicated question, and raises important issues about how doctors and patients should evaluate new information about the risks and benefits of drugs we use.

Before a drug is approved for marketing, it is tested in several thousand patients, and common side effects are identified. However, some side effects are only discovered after a drug is marketed. Some of these are so rare they just didn’t happen before a drug was approved. Others don’t turn up until they are identified in large, carefully conducted trials: An increase in heart-attack risk with Vioxx is a recent example.

There is no organized system in the United States, or elsewhere, to systematically examine the safety of marketed drugs. For many years, the FDA has run a voluntary adverse-events reporting system (AERS) that allows health-care providers and patients to describe possible side effects.

While AERS may generate clues to new side effects, the reports are often incomplete and may raise more questions than they answer. Is the rare effect really caused by the drug? What happens if a few people report something common, like an ulcer or a heart attack? How many people would have to report something before the FDA should get interested?

More reports often help

What is clear is that some of the 400,000 AERS reports submitted each year may represent real side effects, and others do not. One argument says that until further studies understand whether a drug actually causes a side effect, making a suspicion public would be counter-productive; for example, patients benefiting from the drug might stop needlessly.

I see a potential benefit to publicizing AERS reports that the FDA is investigating. Suggesting tenuous relationships between drugs and unusual side effects may prompt other physicians or consumers to recognize that they, too, may have seen (or been) similar cases. More reports do not establish cause and effect, but have helped in the past.

I also see an opportunity for coupling this kind of reporting to increasing public awareness of the risks vs. the benefits of treatment with any drug. An aware public will understand that because the FDA is investigating a potential relationship does not establish that a relationship even exists.

There is no drug that is 100 percent effective and never causes side effects. What we don’t want are drugs where the risks are much greater than the potential benefits, or where we can’t pick out the people at high risk for serious side effects. The new reporting system may, therefore, be one small step toward identifying unsafe drugs.

©2012 An Inconvenient Woman. All Rights Reserved.

On this page:

• Genetic Engineering
• Benefits of GE Animals
• GE Animals Regulated Under New Animal Drug Provisions

The Food and Drug Administration (FDA) is inviting the public to comment on draft guidance that discusses FDA’s approach to regulating genetically engineered (GE) animals.

Although the guidance, released Sept. 18, 2008, is aimed at industry, FDA believes it may also help the public gain a better understanding of this important and developing area. The guidance explains the process by which FDA is regulating GE animals.

Genetic Engineering

Genetic engineering is a process in which scientists use recombinant DNA (rDNA) technology to introduce desirable traits into an organism. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms. Scientists use rDNA techniques to manipulate DNA molecules.

Genetic engineering involves producing and introducing a piece of DNA (the rDNA construct) into an organism so new or changed traits can be given to that organism. The rDNA construct can either come from another existing organism, or be synthesized in a laboratory. Although conventional breeding methods have been used for a long time to select for desirable traits in animals, genetic engineering is a much more targeted and powerful method of actually introducing specific desirable traits into animals.

Genetic engineering is not a new technology. It has been widely used in agriculture, for example, to make crops like corn and soy resistant to pests or tolerant to herbicides. In medicine, genetic engineering is used to develop microbes that can produce pharmaceuticals. And in food, genetic engineering is used to produce enzymes that aid in baking, brewing, and cheese making.

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Benefits of GE Animals

GE animals hold great promise for human and animal health, the environment, and agriculture.

• Health protection of animals – Animals are under development to be more resistant to very painful and harmful diseases, such as infection of the udder (mastitis) in dairy cows and bovine spongiform encephalopathy (widely referred to as “mad cow” disease) in all cattle.
• New source of medicines – Animals can be engineered to produce particular substances, such as human antibodies, to make infection-fighting drugs for people. These “biopharm” animals can change the way we treat chronic diseases, such as bleeding disorders, by providing large quantities of safe, health-restoring proteins that previously were available only from human cadavers.
• Transplantation – Pigs are being engineered so that their cells, tissues, or organs could be transplanted into humans with a reduced risk of immune rejection.
• Less environmental impact – Food animals are being engineered to grow more quickly, require less feed, or leave behind less environmentally damaging waste.
• Healthier food – Food animals, such as pigs, are under development to contain increased levels of omega-3 fatty acids, providing a more healthful product. Livestock can also be engineered to provide leaner meat or more milk.

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GE Animals Regulated Under New Animal Drug Provisions

FDA regulates GE animals under the new animal drug provisions of the law, and the agency must approve them before they are allowed on the market. Food and animal feed from GE animals will undergo FDA review before the food or feed can be marketed. The Federal Food, Drug, and Cosmetic Act defines a drug as “an article (other than food) intended to affect the structure or any function of the body of man or other animals.” Therefore, the rDNA construct intended to change the structure or function of the body of the GE animal is a drug.

FDA may exercise “enforcement discretion” over some GE animals, based on their potential risk and on a case-by-case basis. This means that the agency may not require premarket approval for a low-risk animal. For example, the agency is not requiring premarket approval for GE lab animals used for research, and did not require approval of a GE aquarium fish that glows in the dark. FDA does not expect to exercise enforcement discretion for animal species traditionally consumed as food.

This guidance will help industry comply with FDA’s requirements and will help the public understand FDA’s oversight of GE animals and food from such animals.

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.

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For More Information

FDA welcomes comments on its 25-page draft guidance document at www.fda.gov/dockets/ecomments or www.regulations.gov. Once on this Internet site, select Docket No. FDA-2008-D-0394 and follow the directions. All written comments should be identified with Docket No. FDA-2008-D-0394. The comment period runs for 60 days and closes Nov. 18, 2008.

FDA has developed a number of publications to help inform consumers about the technology of GE animals and the agency’s regulation of these animals. Please visit www.fda.gov/cvm/GEAnimals.htm.

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Date Posted: September 18, 2008Science

©2012 An Inconvenient Woman. All Rights Reserved.

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

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.)

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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Date Posted: September 29, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

The FDA rejected Merck’s request to approve its HPV vaccine, Gardasil for women between ages 27 and 45, citing “issues that preclude approval within the expected review timeframe,” Merck offered no additional specific explanation in their prepared statement.

Merck indicated that it is in ongoing discussions with FDA officials about to the application and expects to officially respond to the agency within the next 30-days. The HPV- vaccine, Gardasil, was approved June 8, 2006 for girls and women between 9 and 26 years old to prevent human papillomarivus related cervical cancer.

Merck statement noted that the FDA identified specific issues related to their application to expand the use of the HPV vaccine, Gardasil to women between ages 27 and 45, in a “complete response” letter, including statement that indicated the data submitted do not support extending Gardasil’s use to include non-vaccine HPV types, or cross protection.

Pharma financial analyst Barbara Ryan of Deutsche Bank writes: “This suggests that Merck believes it has the data in hand to adequately address the concerns, which likely center around efficacy rather than safety considerations. Nevertheless, the timing of the complete response and the subsequent additional review period remain unclear.

“We view the age extension indication as an incremental commercial opportunity, but one where we would also expect a much lower penetration rate. Merck has previously indicated that…use for males, which we believe is the most important incremental opportunity for Gardasil, will be filed later this year.”

©2012 An Inconvenient Woman. All Rights Reserved.

On this page:

• Consumer Complaint Reporting
• Reporting Problems Can Spur Action
• MedWatch Reporting
• How to Report to MedWatch
• Problems to Report to MedWatch
• Reporting Emergencies
• FDA Consumer Complaint Coordinators (regions and telephone numbers)

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear about it.

FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.

1. Consumer Complaint Reporting

FDA’s Consumer Complaint Coordinators (CCC’s) located in FDA offices throughout the United States and Puerto Rico will listen, document your complaint about an FDA-regulated product, and follow up as necessary. Consumers should report problems to the CCC for their geographic region. (See the accompanying list of CCC’s. The list is also on FDA’s Web site at www.fda.gov/opacom/backgrounders/complain.html.)

Some examples of complaints that your CCC wants to hear about are

• food-related illnesses, especially when a specific food is suspected
• allergic reactions when a person has a known allergy to a food ingredient not identified on the product label
• problems related to infant formula
• problems related to baby food
• swollen or leaking canned goods
• suspected product tampering
• adverse events after taking dietary supplements
• problems related to prescription or over-the-counter medications
• problems related to pet food and treats

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Reporting Problems Can Spur Action

If a person reports an illness or injury that appears likely to be caused by an FDA-regulated product, FDA acts immediately. Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.

“Just a few complaints can make a difference,” says Joan Trankle, FDA’s National CCC. For example:

• CCC’s in different parts of the country received three reports of allergic reactions to a type of soymilk. FDA followed up with an inspection of the soymilk company. The product did not declare the allergenic substance, milk protein, on the label, and the company recalled the product.
• CCC’s received two complaints in one week about skin burns after use of an adhesive patch that generates heat to relieve muscle and joint pain. “When that second complaint arrived, we sprang into action,” says Trankle. “We contacted the firm and, based on our follow-up, the firm recalled the product.”

Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information is used during a future inspection of a company to help FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections.

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2. MedWatch Reporting

MedWatch is for reporting any adverse events (unexpected side effects) that occur while using human health care products and some other FDA-regulated products such as

• human drugs (both prescription and over-the-counter)
• medical devices (for example, contact lenses, glucose tests, pacemakers, and medical x-rays)
• blood products, human cell and tissue products, and other biologics (except vaccines, which are reported to another system)
• special nutritional products (dietary supplements, infant formulas, and medical foods such as nutritional supplements used under medical supervision)
• cosmetics

When FDA approves a medical product, the agency has determined that the benefits of the product outweigh the risks. “But every product that FDA approves carries some risk,” says Norman Marks, M.D., Medical Director of FDA’s MedWatch Program. “Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.” So continued monitoring of adverse events is essential and depends on reporting of these events to FDA so they can be entered in MedWatch.

Every MedWatch report is important and is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public, says Marks. “Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death.”

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How to Report to MedWatch

Reporting to MedWatch is easy, confidential, and secure. You provide information about your experience on a MedWatch form. FDA encourages you to have your health care professional either complete the form for you or help you complete the form yourself. “Health care professionals have test results and other clinical information that will help us better evaluate the report,” says Marks.

Reporting by health care professionals is voluntary. If they choose not to report, or if you’d rather file the report yourself, you may use one of these methods:

• Online – Use the interactive form at www.fda.gov/medwatch/report.htm. FDA encourages online reporting because it is the quickest and most direct route.
• Mail – Download the pre-addressed, postage-paid form (FDA Form 3500) at www.fda.gov/medwatch/getforms.htm or call 1-800-FDA-1088 to request the form.
• Fax – Get the form (as above) and fax to 1-800-FDA-0178.
• Phone – Call 1-800-FDA-1088 Mon–Fri between 8:00 a.m. and 4:30 p.m. EST.

If you or your health care professional does not want to complete a MedWatch report, you may report a problem with a health care product to your CCC. “There are times when consumers want to explain their problem and have us record the complaint,” says Trankle. “This gives us the advantage of being able to ask questions and obtain important information that we might not get if they were filling out a MedWatch report.”

CCC’s and MedWatch are for reporting problems; neither provides medical advice. If you experience an adverse event, you should contact your health care professional first and then report the problem to FDA.

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What Happens After Reporting to MedWatch?

• FDA staff enter the report into a database so that it is available for review and comparison to other reports.
• An FDA safety evaluator, often a pharmacist, doctor, or nurse, reviews the report and examines the database for similar reports.
• FDA monitors the data for trends and conducts an investigation if appropriate.
• FDA takes necessary action to protect public health.

FDA actions may include

• issuing safety alerts advising the public and health care professionals to monitor a product’s use, adjust the way it is used, or stop using it
• updating the product labeling to reflect new warnings
• requiring a product to have a Medication Guide—a consumer-friendly instruction sheet provided to patients each time they fill a prescription to help them use the drug safely
• requesting a change in the product’s design, manufacturing process, packaging, or distribution
• requesting a company to recall a product or requiring a manufacturer to conduct further studies to demonstrate the product’s safety prior to allowing the product back on the market

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Reporting Emergencies

If you have a medical emergency, call your health care professional for medical advice. If you wish to report a serious, life-threatening adverse event related to the use of an FDA-regulated product, call FDA’s 24-hour emergency line at 301-443-1240 or call your local FDA Consumer Complaint Coordinator.

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For More Information

Your Guide to Reporting Problems to FDA

www.fda.gov/consumer/updates/reporting_guide061008.html

MedWatch Reporting by Consumers

www.fda.gov/medwatch/report/consumer/consumer.htm

Sign Up for Free MedWatch Safety Alerts by Email

www.fda.gov/medwatch/elist.htm

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Date Posted: June 10, 2008

©2012 An Inconvenient Woman. All Rights Reserved.