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.

Printer-friendly PDF (366 KB)

On this page:

• Tips for Reporting
• Quick-Reference Chart for Reporting Problems to FDA
• Types of Problems FDA Doesn’t Handle

Consumers play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product. The following tips and chart will help you make your report.

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Tips for Reporting

1. Report what happened as soon as possible after you discover a problem. Be prepared with the following information:

• names, addresses, and phone numbers of people affected
• your name, postal and e-mail address, and phone number
• name, address, and phone number of doctor or hospital if emergency treatment was provided
• product codes or identifying marks on the label or container
• name and address of store where product was bought and date of purchase
• name and address of company on the product label

2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that will help FDA trace the product back to the plant.

3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.

4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator listed at www.fda.gov/opacom/backgrounders/complain.html.

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Types of Problems FDA Doesn’t Handle

Contact the agencies listed to report or complain about the following problem areas. See your local phone directory for phone numbers not provided here.

• restaurant food and sanitation—local or state health departments (check blue pages of your local phone book or find your state health department at www.cdc.gov/mmwr/international/relres.html)
• unsolicited products in the mail—U.S. Postal Service at www.usps.gov
• accidental poisonings—Poison Help at 1-800-222-1222 or local hospital
• pesticides or air and water pollution—U.S. Environmental Protection Agency at www.epa.gov/tips/
• hazardous household products (including toys, appliances, and chemicals)—U.S. Consumer Product Safety Commission hotline at 1-800-638-2772 or see www.cpsc.gov/talk.html
• alcoholic beverages—Bureau of Alcohol, Tobacco, Firearms and Explosives at www.atf.gov/contact/hotlines.htm
• drug abuse and controlled substances—U.S. Drug Enforcement Administration at www.usdoj.gov/dea/contactinfo.htm
• hazardous chemicals in the workplace—U.S. Department of Labor’s Occupational Safety and Health Administration at www.osha.gov/html/Feed_Back.html
• warranties—Federal Trade Commission helpline at 1-877-FTC-HELP (1-877-382-4357) or TTY 1-866-653-4261 or see www.ftc.gov/ftc/contact.shtm
• dispensing and sales practices of pharmacies—state board of pharmacy (available at National Association of Boards of Pharmacy at www.nabp.net)
• medical practice—state certification board (check blue pages of your local phone book)

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For More Information

FDA 101: How to Use the Consumer Complaint System and MedWatch

www.fda.gov/consumer/updates/reporting061008.html

Date Posted: June 10, 2008

©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.

Later this year, the US Food and Drug Administration (FDA) will adopt new standards for human clinical trials conducted without its advance sign-off in foreign countries. The rules will govern whether data from such trials can be used in applications to market the drug in question in the United States. Although these new standards specify how to run such trials to meet US requirements, they are worryingly silent on key issues relating to human rights, in contrast with the rules currently in effect. As a result, they could open the way to some ethically fraught decisions.

Take the case of the drug Surfaxin, a synthetic, inhaled version of a lung protein the absence of which is a leading cause of death in premature infants. Back in 2001, the drug’s manufacturer, Discovery Labs of Warrington, Pennsylvania, was looking for a suitable location in Latin America to run a trial on the therapy. But rather than compare its product to one of the several effective drugs already available, Discovery Labs was proposing to administer a placebo to the 325 infants in the control group.

The trial was redesigned only after the FDA — and unfavorable media attention — reminded Discovery Labs that a placebo-controlled trial of this type would be deemed unethical in the United States, and other developed countries, because effective treatments were available. As a result, the control group received alternative active treatments.

The FDA estimates that annually it receives data from around 575 foreign drug trials conducted without its knowledge, more and more of which come from trials run in the developing world. Currently, these trials must comply with the Declaration of Helsinki (or with local country laws, whichever offer the most protection) if sponsors want to use the data to win US marketing approval. The declaration, adopted in 1964, and revised several times since, is today endorsed by medical associations from 85 countries. It is widely considered to be the bedrock of protection for research subjects. Its 1989 revision, which the FDA uses as its present standard, states that any patient in any trial “should be assured of the best proven diagnostic and therapeutic method”.

“The FDA risks sending a message that ethical considerations are

expendable when research subjects live half a world away.”

Yet the FDA announced last month that it will shelve the declaration. Starting in October, the FDA intends to adopt a new standard it calls Good Clinical Practice (GCP), which is modelled on a 1996 document developed by drug regulators and pharmaceutical industry representatives from the United States, the European Union and Japan. Although GCP deals with subject protection, it is in essence a manual on how to conduct rigorous clinical trials, not a human-rights document. For instance, whereas Helsinki explicitly discourages the use of placebos for serious conditions where proven therapies exist, GCP is silent on this issue. So under the GCP guidelines, the FDA could accept data from Surfaxin placebo trials of the future.

The FDA argues that it should not be bound by Helsinki because the declaration is devised by a group it does not control, and is subject to periodic revisions that could confuse trial sponsors or contradict US law. But it is tempting to conclude that the FDA is dropping Helsinki not because it is changeable, but because the agency disagrees with the way it has been changing — in particular with its constraints on the use of placebos. (The US agency is more favourably disposed to placebo use than, say, its European counterparts.)

It makes sense for the FDA to adopt the GCP standard, giving foreign-based researchers guidelines that should help them generate the best data. But if the FDA jettisons Helsinki, the critical underpinning for such efforts, it risks sending a message that ethical considerations are expendable when research subjects live half a world away.

Sources: Nature, International Weekly Journal of Science Editorial

Nature 453, 427-428 (22 May 2008) Published online 21 May 2008

©2012 An Inconvenient Woman. All Rights Reserved.

Researchers found patients given the drugs were a third more likely to die within a month of surgery than those given a dummy pill.

Those on the blood pressure-lowering drugs also had double the risk of having a stroke.

The study, by Canada’s McMaster University, appears in The Lancet.

“There is a real potential that beta blockers are causing serious harm in the surgical setting”

— Dr PJ Devereaux, McMaster University

Although use of the drugs did reduce the risk of a heart attack following surgery, the researchers concluded that on balance they did more harm than good.

They estimate use of the drugs before surgery may have contributed to at least 800,000 deaths worldwide in the past decade.

Professor Peter Weissberg, medical director of the British Heart Foundation, said the research emphasised the importance of undertaking large clinical trials, rather than assuming that drugs will only do what is expected of them.

“Fortunately, the practice of giving beta blockers to all patients at risk of vascular disease before surgery is not widespread in the UK.”

“Also, the results of this trial – of a relatively high dose of a beta blocker given before surgery – do not mean patients stabilized on long-term beta blocker therapy will be at increased risk if they have surgery.”

Researcher Dr PJ Devereaux said: “There is a real potential that beta blockers are causing serious harm in the surgical setting.”

“If my mother was undergoing surgery and given a beta blocker, I would be extremely upset based on this evidence.”

Counter to stress

It has long been thought that using beta blockers before major surgery protects the heart against the stress of the procedure.

Surgery often raises levels of stress hormones known as catecholamines, which drive up a person’s blood pressure and heart rate.

Beta blockers block the effects of increased catecholamines.

However, the body can also go into a state of shock after surgery during which blood pressure falls. The researchers suspect that beta blockers may amplify this state.

The McMaster team studied more than 8,000 patients in 23 countries who were undergoing major surgery unrelated to the heart, but who had or were at risk of clogged arteries.

Half were given the beta blocker metoprolol two to four hours before and 30 days after their surgery. The other half got a placebo.

The results suggests that the use of beta blockers could prevent 15 out of every 1,000 people with similar risks undergoing similar surgery from having a heart attack.

However, eight more people would die, five more would have a stroke, 53% would have abnormally low blood pressure and 42% would have an abnormally slow heart beat.

Overall, the risk of death rose from 2.3% for the placebo group to 3.1% for those given beta blockers in the 30 days after their operation.

Source: BBC NEWS and The Lancet

©2012 An Inconvenient Woman. All Rights Reserved.

In my opinion, the troubled agency’s close ties and financial dependence on Big Pharma

has been weakened its ability to perform its primary function — protecting the public. The FDA’s documented failure to impartially judge the veracity of drug trial results and enforce safety oversight of the pharmaceuticals currently on the market has lead to recalls, restatement of the drug side effects and the numerous, harmful, unintended consequences.

I am signed up for, and read, every FDA publication available to the public. Actually I study them. Inconvenient women educated themselves to the very best of our ability. We owe it to ourselves, our families, friends and anyone else within our sphere of influence.

However, for now, the existing FDA is the closest thing the American public have to a drug safety data bank; and the following information and resources offer a good foundation for any inconvenient woman who intends to ask questions and expect clear answers.

THE FDA

The Food and Drug Administration (FDA) approves a drug for marketing after determining that the drug’s benefits of use outweigh the risks for the condition that the drug will treat. But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population. This guide offers descriptions of some of the drug safety terms commonly used by FDA throughout the life cycle of a drug.

FDA REVIEW

Pre-Clinical Data: Before a drug can be tested in people in the United States, sponsors (drug manufacturers, research institutions, and other organizations that develop drugs) must show FDA results of testing they have done in laboratory animals and what they propose to do for human testing.

New Drug Approval Process: After the animal testing stage, FDA decides whether it is reasonably safe for the company to move forward with clinical trials—studies that evaluate the safety and effectiveness of a drug in healthy people and in patients. The drug company submits the results of such studies to FDA for review. The agency conducts a thorough review of the safety and effectiveness data, and considers how the benefits compare to the risks when making a decision of whether or not to approve a drug.

Adverse Drug Reaction: An adverse drug reaction, also called a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.

TAKING MEDICATION

Medication Guides: Medication Guides are paper handouts/pamphlets that are required to be distributed to patients with certain medications by the pharmacist. Medication Guides convey risk information that is specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. www.fda.gov/cder/Offices/ODS/medication_guides.htm

Consumer Medication Information (CMI): Compared to a Medication Guide, a Consumer Medication Information sheet offers broader information on how to use a medicine. CMI sheets are not developed or regulated by FDA. These information sheets are prepared by pharmacies and given out with prescription drugs. CMI sheets are not available on the FDA Web site. The sheets help consumers understand key information about their prescription medicine, including how to take it, how to store it, and how to monitor their treatment. The sheets also include information on precautions and warnings, as well as symptoms of serious or frequent adverse events and what to do if you experience one.

Prescription Drug Labeling: Drug labeling, commonly called the package insert or the prescribing information, provides information to the physician about what a prescription medication is supposed to do, who should and should not take it, and how to use it. Labeling also includes information on a drug’s side effects and warnings, and information from the clinical trials of the drug. Some prescription drug labeling also includes a part that describes the prescribing information in words that consumers will understand.

Nonprescription Drug Label (“Drug Facts”): For an over-the-counter (OTC), or nonprescription medicine, information printed on the medication bottle or package under the heading Drug Facts is important for taking care of yourself and your family. The Drug Facts tell you what a medicine is supposed to do, who should or should not take it, and how to use it. Safety information and instructions for use are displayed in a uniform and easy-to-read format.

Boxed Warning: This type of warning is also commonly referred to as a “black box warning.” It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.

MONITORING AFTER APPROVAL

Post-Market Surveillance: Post-market surveillance is the process by which a drug’s safety is monitored on an ongoing basis after a drug is approved by FDA. Post-market surveillance seeks to identify problems that were not observed or recognized before approval and any problems that may arise because a drug may not be used as described in the drug labeling, or because a drug is being manufactured incorrectly.

Adverse Event Reporting System (AERS): AERS is a computerized database containing reports of adverse events. It supports FDA’s post-market safety surveillance program for all approved drugs and therapeutic biologics. www.fda.gov/cder/aers/default.htm

MedWatch: MedWatch is FDA’s safety information and adverse event reporting program. It provides important and timely medical product information to health care professionals, including information on prescription and over-the-counter drugs, biologics, medical devices, and special nutritional products. Health care professionals and consumers can also report serious problems they suspect are related to certain FDA-regulated products. www.fda.gov/medwatch/safety.htm

REMOVAL FROM THE MARKET

Drug Recall: A drug recall is an action taken by a firm to remove a product from the market that FDA considers to be in violation of the law. Recalls are classified as Class I, Class II, or Class III. Class I recalls are the most serious and involve situations where there is a reasonable probability that the use of or exposure to a violative product, will cause serious adverse health consequences or death. A drug may be recalled due to factors such as problems with packaging, manufacturing, or contamination.

Drug Withdrawal: In rare cases, FDA may need to reassess and change its approval decision on a drug. A conclusion that a drug should no longer be marketed is based on the nature and frequency of the adverse events and how the drug’s benefit and risk balance compares with treatment alternatives. When FDA believes that a drug’s benefits no longer outweigh its risks, the agency will ask the manufacturer to withdraw the drug.

TYPES OF SAFETY ANNOUNCEMENTS

Early Communication About an Ongoing Safety Review: This type of communication is part of FDA’s effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review.

Public Health Advisories: These advisories provide important drug safety information and recommendations of actions that can be taken by patients or caregivers to avoid or minimize harm from a drug. They are issued when FDA has information that would help doctors and patients make better treatment choices. www.fda.gov/cder/news/pubpress.htm

Letters to Health Care Professionals: These are letters—often referred to as “Dear Doctor” letters—that are developed by drug companies often with input from FDA. The letters educate health care professionals about new and important drug information.

Information for Health Care Professionals: Also referred to as a Healthcare Professional Information sheet, this information from FDA is for doctors, pharmacists, nurses, and other health care professionals. It contains an “alert” (a summary of the new safety information), detailed information about the safety issue, factors to consider when making treatment decisions, information for health care professionals to discuss with patients about their roles in reducing the risks from the drug, and a summary of the facts or data that serve as the basis for the information in the sheet.

FIND THE LATEST INFORMATION

Index to Drug-Specific Information: This index features an alphabetical listing of drugs that have been the subject of a Public Health Advisory, a Healthcare Professional Information sheet, an Early Communication About an Ongoing Safety Review, or other important information. www.fda.gov/cder/drug/drugsafety/DrugIndex.htm

MedWatch Alerts: MedWatch provides important and timely medical product information, and is also a venue for reporting adverse events to FDA. You can sign up to receive MedWatch notices by e-mail. www.fda.gov/medwatch/

DailyMed: Developed with the National Library of Medicine, DailyMed is a Web site that gives physicians and patients electronic access to FDA-approved drug labels. http://dailymed.nlm.nih.gov

Drugs@FDA: This resource allows you to search for information about FDA approved brand name and generic drugs and therapeutic biological products. These are proteins derived from living material (such as cells or tissues) used to treat or cure disease. You can search in many ways, including by drug name and active ingredient. www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

FDA Drug Safety Podcasts: Podcasting is a method of publishing and syndicating audio broadcasts through the Internet. These provide emerging safety information about drugs in conjunction with the release of Public Health Advisories. www.fda.gov/cder/drug/podcast/default.htm

FDA Drug Safety Newsletter: Aimed at health care professionals, this quarterly publication is designed to enhance communication of safety information after a drug is marketed. The newsletter raises awareness of adverse events and stimulates reporting of adverse events. www.fda.gov/cder/dsn/default.htm

FDA Consumer Health Information: FDA offers timely and easy-to-read articles on product approvals, safety warnings, and other health information. Articles cover all FDA-regulated products, including human drugs, drugs and feed for animals, medical devices, vaccines, blood, food, dietary supplements, and cosmetics. To find these articles, visit the Web page at www.fda.gov/consumer/default.htm

You can also sign up to receive notices of new consumer articles at www.fda.gov/consumer/consumerenews.html

Recalls, Market Withdrawals and Safety Alerts: FDA provides information on drug products that have been recalled due to manufacturing problems and/or safety concerns. In addition to information released to the public by a manufacturer using the normal media channels, FDA posts information about these recalled drug products at www.fda.gov/opacom/7alerts.html

You can also sign up to receive e-mail notices of product recalls.

For More Information

FDA’s Center for Drug Evaluation and Research

www.fda.gov/cder/index.html

FDA’s Drug Safety Initiative

www.fda.gov/cder/drugSafety.htm

©2012 An Inconvenient Woman. All Rights Reserved.

By Devra Davis, PhD, MPH

Review by Leslie Botha, Holy Hormones Honey!

In a recent interview on CSPAN Davis stated, “For much of its history, the cancer war has been fighting the wrong battles, with the wrong weapons, against the wrong enemies.”

The Secret History of the War on Cancer by Dr. Devra Davis shows, decade by decade, how the campaign has targeted the disease and left off the table the things that cause it—tobacco, alcohol, the workplace, and other environmental hazards. Conceived in explicitly military terms, the effort has focused on defeating an enemy by detecting, treating, and curing disease. Overlooked and suppressed was any consideration of how the world in which we live and work affects whether we get cancer. The result is appalling: over 10 million preventable cancer deaths over the past thirty years.

This has been no accident.

With each page of Davis’ carefully crafted book, readers will become more conscious of the obvious issues that have been ignored or marginalized and appalled by the attitude and actions of America’s medical profession, the American Cancer Society, the petrochemical industry and, “our” government. Many of us concerned with the health and wellness of women and girls knew something just wasn’t right; but Dr. Davis’s book moves us from inkling to awareness.

Filled with compelling personalities and never-before-revealed information. The Secret History of the War on Cancer is the gripping story of a major public health effort diverted and distorted for private gain. It carefully documents how, over time, the “WAR” on Cancer has come to be orchestrated by the leaders of those industries that made cancer-causing products, and who sometimes profited from drugs and technologies for finding and treating the disease.

Davis, driven by the conviction, writes with passion about premature deaths, and preventable illnesses resulting from exposure to industrial toxins and presents a powerful call to action. In the book she proposes a kind of truth-and-reconciliation approach to get industry and public health experts mutually involved; but notes that, based on the continued loss of life, change is simply not happening fast enough.

Among the Findings Described in The Secret History of the War on Cancer

— As early as 1936, the world’s leading cancer scientists understood that tobacco, diagnostic and solar radiation, benzene, and hormones caused cancer. The preparation and conduct of World War II with its focus on immediate survival effectively sidetracked these early findings of cancer hazards.

— Many more young people (those under 40 years of age) are getting cancer. One of the reasons may be the excessive use of x-rays in infants and children, and our failures to reduce exposures to other cancer hazards like those in urban air or agents that can leach from some plastics. Earlier this year, the American College of Radiology advised against unnecessary and excessive use of CT and other forms of diagnostic radiation in children, warning that this will further add to the growing cancer burden in young people today.

— When first reports emerged that coke oven workers had higher rates of lung cancer in the 1970s, some suggested that this was because most of them were black. Not until similar findings showed up in white Mormon workers five years later, was the link between coke oven work and lung cancer established. While one in eight Americans today is black, one in three works in a blue collar job, and one in five lives within two miles of a hazardous waste site. This increased environmental burden has never been considered when trying to understand why rates of prostate, breast, and colo-rectal cancer are so much higher in blacks than whites.

— Davis cited women chemist in Shanghai had a 14% increased incidence of breast cancer; chemists around the world also have a higher rate of cancer – due to poor protection in the laboratory.

— The life-saving test for cervix cancer, called the Pap smear, was not put into use for more than a decade after it was shown to save lives, because of fears that it would undermine the private practice of medicine. These delays led to the deaths or unnecessary surgery of millions of women, who succumbed to an illness that could have been avoided.

— Pasteur developed the germ theory of disease and was concerned about infectious disease. His dying words were; “remember the host; remember the host conditions” – in reference to milkmaids and their carrying infectious germs – without necessarily becoming ill from them.

— Old approach to curing cancer came out of WWII and the poison Gas Therapy

Leukemia – over abundance of white blood cells (weiss blut) chemotherapy was developed as a poison gas to fight the cells and was developed as secret army research.

—New paradigm of treating cancer includes boosting the immune system and the development of extracts from broccoli, chocolate and red wine to fight what many are coming to believe are cancers that are viral in nature.

Concerning Hormones and Cancer…

Davis reintroduces Barbara Seaman’s 1969 book, The Doctors’ Case Against the Pill, which was the basis for the Nelson Pill Hearings on the safety of the combined oral contraceptive pill. As a result of the hearings, a health warning was added to the pill, the first informational insert for any prescription drug. Robert Finch, Secretary of HEW, wrote Seaman “… THE DOCTORS’ CASE AGAINST THE PILL… was a major factor in our strengthening the language in the final warning published in the Federal Register to be included in each package of the Pill.” The dramatic events surrounding the hearings also brought together many soon-to-be prominent health feminists for the first time, and encouraged them to pursue further action. In 1975 Seaman co-founded the National Women’s Health Network with Alice Wolfson, Belita Cowan, Mary Howell, M.D., and Phyllis Chesler, Ph.D. According to Davis – we should have listened to Barbara’s warning thirty years ago. Dr Seaman is now celebrated in the same medical circles that blackballed her then. The government has finally confirmed that her warning about synthetic estrogen was correct.

— Davis cites studies showing HRT raises the risk of breast cancer, blood clots, heart attacks and dementia.

— About HPV …it is a factor in not just cervical cancer, but laryngeal and an anal — however the vaccine has not been fully tested as an agent against infectious disease.

—Questionable HPV Trail Methodology — Less than 20,000 girls between the ages of 15 – 25 were tested, and yet the CDC recommends the vaccine for girls as young as 11 and 12. Davis raised the question of what about the boys? And noted that two of three sexual encounters for teens less than 18 yrs old ARE NOT CONSENTUAL.

What People Are Saying

“A breathtaking, impeccably documented wake-up call for what we should have done and what we must do!”

— Teresa Heinz Kerry, co-author of This Moment on Earth

“With the mastery of a great writer, Devra Davis takes the reader inside the successes, the failures, and the ambiguity of research on cancer.”

— Lorenzo Tomatis, MD, Former Director,

International Agency for Research on Cancer, World Health Organization

“The Secret History of the War on Cancer is a masterful combination of scientific insights and investigative journalism. If you want to know why one in three Americans develops cancer, read this book.”

—Mitchell Gaynor, MD, President, Gaynor Integrative Oncology

About the Author

Devra Davis, Ph.D., M.P.H., is the Director of the Center for Environmental Oncology at the University of Pittsburgh Cancer Institute and Professor of Epidemiology, Graduate School of Public Health. She was appointed by President Clinton to the U.S. Chemical Safety and Hazard Investigation Board in 1994 and also served as Scholar in Residence at the National Academy of Science. She works in Pittsburgh, and lives in Washington, D.C.

A portion of the profits from this book will go to support research on cancer prevention.

OK! OK! I’ve read it NOW WHAT!

This book is a timely, well-written, and stunning exposé — Share It.

• Request your local library ordered a copy of the book.
• If your local bookstore is not carrying the book, request that they order it.
• Start a reading group based at your local bookstore.
• Request that your local high school and college libraries order the book. If they don’t have the budget, buy it your self and donate the book to the library (Donations are a tax deductible action)
• Buy and send a copy to our congressional representative, and ask what he/she plans to do to stop the uncontrolled use and dumping of toxins into our environment and to protect the health of people who what to work with or around these chemicals and environmental toxins.
• Talk to your friends and family about the book and what it means to their health.

Inconvenient Women do not get Angry — We Get ACTIVE!

©2012 An Inconvenient Woman. All Rights Reserved.

Take Heavy Criticism Over Vytorin Failure

This week Merck executives are very grateful for the revenue predictions for their blockbuster HPV vaccine, GARDASIL. Profits are predicted to climb from $300 million to $4 billion over the next year. After the Vytorin debacle —they’re going to need the cash.

So lock up your daughters, bought and paid for Politicians like Texas Governor Rick ‘Executive Order’ Perry[1] are perfectly willing to help out their generous friends in the “name of good public heath policy”

Barbara Loe Fisher, in her powerful November 06, 2007 Blog, Vaccine Awakening

summarized the issue in one insightful paragraph:

“One day enough voters will figure out that vaccinating 300 million Americans and 33 million Canadians with multiple vaccines from cradle to the grave has more to do with keeping drug companies in the money than keeping people healthy. Then the politicians, who have committed hundreds of millions of taxpayer dollars to underwrite new product rollouts for pharmaceutical companies selling vaccines while shielding them from all liability for vaccine injuries and deaths, will be looking for another job.”

Vytorin — The Latest FDA Failure To Protect the Public

On Sunday [3/30/08], executives at Merck and Schering-Plough were visibly shocked when an expert panel here at the American College of Cardiology meeting told thousands of doctors not to use their top-selling drugs, Zetia and Vytorin. That night, at a press conference, they strongly contested arguments that they had not proved the drugs were safe.

On Monday morning, things got worse. Rival AstraZeneca said it had stopped its 15,000-patient clinical trial of its Crestor because an independent safety committee said there was proof the drug prevents heart attacks, strokes and deaths. The result came six months ahead of schedule.

For the medical community, the Crestor news is a big deal for two reasons. First, it provides definitive proof Crestor has lifesaving benefits like other statin drugs, such as Lipitor, Zocor and Pravachol. Second, it provides key evidence that these medicines can prevent heart attacks even in patients who have normal cholesterol but have other risk factors for heart disease.

In particular, the patients in the Crestor trial had high levels of C-reactive protein (CRP) in the blood. The protein is thought to be a measure of inflammation in the arteries, and inflamed arteries are more likely to develop the clots that cause heart attacks and strokes. The experiment was designed to test whether people who had normal levels of bad cholesterol but high CRP could be helped by statin therapy. Up until now, evidence for statins has been mainly in people with high “bad” cholesterol, properly known as low-density lipoprotein (LDL).

“It’s splendid news, and that’s sort of what they were waiting for to decide where CRP fit,” says Roger Blumenthal, who directs preventative cardiology at Johns Hopkins University. “This is a boon to AstraZeneca and the field.”

Weighing the proof that high CRP is a risk factor for heart disease that should be treated will have to wait until the study’s results are analyzed and presented. But the study could also be a big victory for Paul Ridker, the Brigham and Women’s Hospital cardiologist who headed up this trial and has spent a lot of his career doing pioneering work on CRP.

The study is more bad news for Merck and Schering-Plough , though. The American College of Cardiology panel and two editorials in The New England Journal of Medicine recommended sidelining use of Zetia, a kind of cholesterol drug that works differently from statins, and Vytorin, a combo pill of Zetia and the statin Zocor. Instead, they said, push the doses of statins where there is proven evidence.

“We now have data for every statin marketed that shows a reduction in morbidity and mortality,” says Steven Nissen of the Cleveland Clinic, who had recommended Zetia be treated as a “last resort” months ago. “This really does emphasize what the panel said yesterday. Whatever statins do, and however they do it, it really works across the entire class. It really is a tremendous emphasis that statins are the first choice and why they are the first choice.”

Nissen has a somewhat tangled history with Merck and Schering-Plough. He raised concerns about Merck’s Vioxx in 2001, before the drug was yanked from the market. And Merck and Schering-Plough scrapped plans to do a Vytorin imaging trial with him.

But the emerging consensus about Zetia has been striking: The majority of cardiologists interviewed at the American College of Cardiology meeting foresee a pullback in use of the drug until there is more science about how exactly it works. Merck and Schering-Plough have one trial testing whether Zetia prevents heart attack and stroke, and the study is not expected to end until 2012. The Zetia trial started exactly three years after the Crestor trial that was just halted, according to http://www.ClinicalTrials.gov.

[1] From Wikipedia

On February 2, 2007, Perry issued an executive order mandating that Texas girls be vaccinated with Gardasil, a newly approved drug manufactured by Merck that protects against some strains of the human papilloma virus which causes cervical cancer. The move made national headlines.[30]

Perry’s move has been criticized by some social conservatives and some parents due to concerns about the moral implications of the vaccine and safety concerns. On February 22, 2007, a group of families sued in an attempt to block Gov. Perry’s executive order.[31] Several financial connections between Merck and Rick Perry have been reported by news outlets, such as a $6,000 campaign contribution, as well as Merck’s hiring of former Perry Chief of Staff Mike Toomey to handle its Texas lobby work.[32]

Adding to the criticism of Perry’s order is what is viewed by some as a high price of the vaccine which is approximately $US360 in Texas.[33] Gardasil is a patent-restricted vaccine and Merck is the sole producer.

On May 9, 2007, Perry allowed a bill to go into law that would undo his executive order.[34]

Source: Forbes.com Matthew Herper, 03.31.08

©2012 An Inconvenient Woman. All Rights Reserved.

FDA’s Mission Statement

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

History of FDA

http://www.emedicinehealth.com/fda_overview/article_em.htm

How FDA conducts clinical trials to see whether drugs are safe and effective:

• Medical schools at public and private universities;
• The drug manufacturer seeking FDA approval;
• For-profit companies working for drug manufactures.

The cost of expensive clinical trails to demonstrate a new drug is safe and effective typically is paid by the drug manufacturer.

The user fee act, approved by Congress in 1992 , was reauthorized in 1997 and 2002 . Since its enactment, it has permitted the FDA to increase its staff to review new drugs from 1,277 in 1992 to 2,503 in 2004 .

Fees paid by the drug industry to the FDA to speed promising treatments to market have doubled from 1998 to 2005.

In fiscal 2004, drug companies paid $232 million in fees to the FDA, accounting for 53 percent of the agency’s $436 million budget for new-drug review. The 2007 budget includes $320.6 million in fees to be paid by drug makers.

The FDA is requesting additional funding from drug makers to support increased after-market safety. An estimated $100 million is needed to add needed drug safety personnel and other improvements.

Every 100 additional reviewers shortened the time it took the FDA to consider a new drug application by 3.4 months.(2)

In 2005, the median time for review and approval was six months for high-priority drugs.

Over the past ten years, the proportion of drug industry funding for the review of new drugs, has increased from 20 to 53 percent.

“For the FDA to be “perceived as independent” the funding it receives from drug companies should be limited.”

— Eli Lilly & Co. chief executive Sidney Taurel

Sources:

(1) Drug makers lobby US to hike FDA funds Firms say taxpayers should pay bigger part of bill for safety tests

The Boston Globe / Boston.com

(2) Harvard University government professor Daniel Carpenter.

©2012 An Inconvenient Woman. All Rights Reserved.

The Food and Drug Administration (FDA) today announced a series of new policy and regulatory developments to strengthen the Agency’s oversight and protection of patients in clinical trials and the integrity of resulting data in an effort to modernize the agency’s approach to bioresearch monitoring as part of the Critical Path Initiative. The Human Subject Protection and Bioresearch Monitoring (HSP /BIMO) Initiative will facilitate the modernization of the regulation of clinical trials and bioresearch monitoring, specifically the protection of human subjects and the integrity of data in clinical trials, and encompasses devices, foods, human drugs, biological drug products and veterinary medicine.

The new effort is part of an HHS-wide initiative to employ recent advances in basic science, including genomics and molecular analysis, in order to bring about more effective development and review of therapies, and to enable increasingly targeted and individualized care management for patients.

“As clinical trials continue to evolve, in particular becoming increasingly large, decentralized and global, the FDA’s approach to bioresearch monitoring and human subject protection must also evolve and modernize,” said Janet Woodcock, FDA Deputy Commissioner for Operations at this year’s Drug Information Association annual meeting. “BIMO will help FDA modernize biomedical research monitoring making the most efficient use of its resources to help ensure the safe conduct of clinical trials, including taking appropriate opportunities to leverage existing oversight done by private entities to accomplish the Agency’s risk minimization goals.”

Clinical trials have evolved dramatically since FDA first began inspecting them in 1977. In an effort to protect the rights and welfare of human subjects and to verify the quality and integrity of data submitted for review, FDA established over time a bioresearch monitoring program that included the development and implementation of compliance programs to provide guidance for inspections of investigators, sponsors, contract research organizations, institutional review boards and bioequivalence facilities. With the expansion of clinical trial studies and sites, electronic record-keeping in the studies, and greater participation by vulnerable subjects in clinical trials, the role of FDA’s bioresearch monitoring compliance programs must expand and evolve as well. The HSP/BIMO Initiative addresses that need.

Over the past year and a half, FDA has carefully inventoried its programs and identified issues to launch the HSP/BIMO Initiative. As this initiative moves forward, FDA will continue to gather additional issues for the initiative and related information from internal and external stakeholders, e.g., industry, academic, and government activities and programs, and intends to conduct workshops and create other opportunities for public input.

Janet Woodcock, M.D., Deputy Commissioner for Operations, will chair the HSP /BIMO steering committee which is comprised of representatives from the Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Food, Safety, and Nutrition (CFSAN), Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA), and the Office of the Commissioner (OC).

Highlights of what has been completed to date include:

• Draft Guidance; Process for Handling Referrals to FDA Under 21 CFR 50.54; Additional Safeguards for Children in Clinical Investigations, published May 2006
• Guidance for Industry – Using a Centralized IRB Process in Multicenter Clinical Trials, published in March 2006
• Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, published in March 2006
• Information Sheet Guidances for IRBs, Clinical Investigators, and Sponsors, five published in final January 2006

Projects in progress:

• Modernizing adverse event reporting to institutional review boards (IRBs) to accommodate major trend toward multicenter trials (March 2005, held Part 15 Hearing – Adverse Event Reporting to IRBs, currently working on draft guidance)
• Published proposed rule: Institutional Review Board – Registration Requirements, FDA reviewing comments
• Finalizing rule: Foreign Clinical Studies not Conducted Under an IND (21 CFR 312.120)

FDA News

FOR IMMEDIATE RELEASE

P06-86

June 26, 2006

Media Inquiries:

Laura Alvey, 301-827-6242

Consumer Inquiries

888-INFO-FDA

©2012 An Inconvenient Woman. All Rights Reserved.