DeLauro Seeks Info From FDA Amid Political Influence Concerns

Corporate Greed and the FDA’s Failure to Protect

Reported by Barbara Loe Fisher

The vaccine reaction reports keep coming into the National Vaccine Information Center (NVIC) from mothers describing how they took their healthy teenage girls into a pediatrician or gynecologist’s office where they were given a GARDASIL shot and, then, nothing was ever the same again.

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

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

Last week a nurse who is an administrator in the outpatient department for a group of hospitals in California called and asked if NVIC had been getting reports of unusual collapse after GARDASIL vaccination. I said, yes, we are getting those reports and she said “A lot of our patients are collapsing after the shot is given. It happens with GARDASIL more frequently than with any other vaccine we give.” That same week, NVIC received a report from the mother of a 15-year old daughter who got her first GARDASIIL shot last month. Within 10 minutes of being injected, she collapsed and had her first grand mal seizure, became incontinent, temporarily lost vision in her right eye, suffered uncontrolled vomiting and had to be taken by ambulance to the hospital. Another report to NVIC that week also involved first-time seizures in a 15-year old girl after she got a GARDASIL shot.

Through June 30, 2008, there have been reports that at least 17 to 20 deaths have occurred following GARDASIL and were filed with the federal Vaccine Adverse Events Reporting System (VAERS), although the FDA has yet to admit even one death is causally related to the vaccine, suggesting that the girls would have died that day even if no vaccine had been given.

Many of the teenage girls, who die suddenly after vaccination without explanation, were among the brightest and the best and in top physicial condition. This was true for 17-year old Jessica Ericzon, a New York softball player, snowboarder and honor roll student who dropped dead within 48 hours of getting a GARDASIL shot. A coroner could find no cause for her death after an autopsy.

There have been so many reports of reactions, injuries and deaths following GARDASIL vaccination (20-25 percent of all vaccine adverse event reports being filed with VAERS are for GARDASIL vaccine reactions) that the FDA and CDC issued a statement defending the vaccine’s safety on July 22, 2008.

But one of the vaccine’s developers has urged caution and offers practical advice about the need for continued use of Pap screening to prevent cervical cancer rather than relying on the vaccine to do the job. ” If you are at all concerned, then don’t have the vaccine – have regular Pap smears and you will be equally protected from cervical cancer….Pap screening is still the only proven method we have for cervical cancer prevention,” said Professor Diane Harper, Ph.D. “We don’t know how long the vaccine will protect a woman from HPV infection, and the vaccine does not protect against all types of HPV infection that cause cervical cancer.”

The “coincidence” defense mounted by doctors and drug-company officials every time a vaccination is followed by injury and death is as old as it is unscientific.

It is amazing that they have been able to get away with it for so long. Babies can’t talk and babies can’t walk so who they will become is still a dream. But young girls and women have already become much of who they will be and, on the cusp of fulfilling the dream, their vaccine deaths and injuries are much more difficult to sweep under the carpet.

It is immoral for doctors in government and industry to continue to look away from the damage done when vaccines cut down the brightest and most physically fit among us. The suggestion that these healthy, high functioning girls were biologically compromised and would have died or been injured that day even if no vaccine had been given is ludicrous. If those in government responsible for protecting the public health and safety look the other way when healthy individuals die and are injured by pharmaceutical products pronounced by government as “safe” for public use, then we cannot be assured that any licensed drug or vaccine is safe.

Last year, the head of the FDA in China was executed for allowing toxic pharmaceutical products to be licensed and released for public use that ended up killing and crippling people.

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

http://www.NVIC.org

http://www.StandUpBeCounted.org

©2012 An Inconvenient Woman. All Rights Reserved.

The passage of DSHEA witnessed the biggest victory for consumers in the history of Congress. More letters were written to Congress than on any other piece of legislation in the history of our country. The voice of the people spoke louder on dietary supplements than even on the Vietnam war. This historic legislation assured the public’s right to safe and high quality dietary supplements. The people expressed their overwhelming desire to take care of themselves, by accessing dietary supplements to prevent the onset of chronic disease and reduce the risk of ill health.

The American public spoke for health and wellness choices. President Bill Clinton, in signing the bill, said, “The passage of this legislation…speaks to the diligence with which an unofficial army of nutritionally conscious people worked democratically to change the laws in an area deeply important to them.”

Now the people must speak again to preserve their legacy under DSHEA—for good health care options, to access dietary supplements, and to make Congress listen to you, the American people. Since the passage of DSHEA, the FDA has failed to fully implement and enforce the law. The FDA failed to prevent the misuse of the herb, Ephedra, which put people at risk. Critics say the industry is unregulated and that dietary supplements are dangerous. They claim consumers must be protected. These are lies. These lies are used to advocate that Congress give even more powers to FDA. If government wants to protect consumers, it must make FDA enforce DSHEA, not destroy it. Let’s protect consumers’ freedom to choose health-enhancing dietary supplements. The FDA has the powers, given to it under DSHEA, to seize products and to warn, to fine, to prosecute and to jail manufacturers who do not obey the law.

Yet, the FDA has failed to act. What’s been happening in Washington DC?

There are now five bills pending before Congress that will affect your rights to access safe and beneficial supplements.

Under the guise of protecting the public, these bills will make it easier to take away public access to supplements. The FDA is unable, or is unwilling, to enforce the law.

Only one bill recognizes the possibility that the FDA needs more money to fulfill its duties under DSHEA. The Hatch Harkin bill, S. 1538, says we should give more money to the FDA to do its job.

The other four bills seek to give the FDA even more powers—powers that would quickly destroy your nutritional health care rights.

Public confidence in the safety and quality of dietary supplements has come under pressure because the FDA has not taken action to enforce the law.

The FDA does not need more powers. It needs to use the powers it already has to assure your dietary supplements are safe and of high quality. It can and it will when you, the American people, send a clear message back to Congress—Do not mess with DSHEA, help the FDA fully fund and implement the law!

In response to the actions of Congress, the Nutritional Health Alliance, one of the main organizations that fought so hard for its passage of DSHEA ten years ago, has activated a new Save and Strengthen DSHEA campaign. The NHA will work with other like-minded groups and individuals to achieve these objectives. Don’t let Congress take your dietary supplements away—protect your rights and protect DSHEA. In the coming months, you will be hearing from the NHA and we will work with consumers and store owners to make sure your voices are heard in Washington DC.

Go to www.nha2004.com and voice your support for DSHEA. Access the names and addresses of your Congressmen and Senators, view sample letters and fax and write Congress today. Prevent the loss of your right to stay healthy with dietary supplements. Don’t let Congress take your dietary supplements away!

Pending Bills in Congress Could Take Away Your Health Care Rights to Buy Vitamins and Herbs Nutritional Health Care Alliance Reactivated to Protect DSHEA

©2012 An Inconvenient Woman. All Rights Reserved.

Big Pharma is at it again, this time teaming up with other anti-supplement cohorts to spearhead a petition that urges the Food and Drug Administration (FDA) to implement stringent new limitations on manufacturers of weight-management supplements. Of course, it should come as no surprise that the particular large pharmaceutical corporation which helped launch the petition is the very same company that recently released the first-ever FDA-approved over-the-counter (OTC) weight-loss drug. It’s as transparent as it seems: Big Pharma is after big bucks, and it will stop at nothing to eliminate the competition.

The pharmaceutical industry has a lot riding on OTC weight-loss pills. Safe, natural nutrition that works with the body to support healthy weight management is a considerable threat to Big Pharma’s OTC weightloss drug profits. Consumers are increasingly aware that while nutrition supports health as nature intended, drugs can subject them to side effects and even neutralize nutrition’s benefits.

The recently approved OTC weightloss pill exemplifies this: By acting on the body’s absorption of fats within the intestines, the drug inhibits the body’s ability to absorb important fat-soluble nutrients like vitamins A, D, E and K. As for the weight loss drug’s potential side effects—suffice it to say that the drug’s manufacturer cautions that users may have to wear dark pants and bring a change of clothes to work.

Being Overweight Is a Disease?

As questionable as the OTC weight-loss drug may be in and of itself, it is the latest development—the drug’s manufacturer urging the FDA to crack down on weightmanagement supplements— that is most disturbing. The petition’s logic: Nutritional supplements should not be allowed to claim that they support healthy weight management because being overweight really should be regarded as a state of disease. According to the law, only drugs may claim to have an effect on disease. But since when is being overweight, even just a few pounds, a disease?

Even more absurd is the petition’s next illogical leap: It claims that since being overweight can be associated with disease states, then supplements that support healthy weight management are, by proxy, claiming to have an impact on those diseases. That’s quite a stretch! The petition’s authors appear to be trying very hard to create a link between weight management supplements and disease claims that simply does not exist—as a result, the petition appears desperate and nonsensical.

Weight Loss the Right Way

Meanwhile, nutritional supplement manufacturers market their products truthfully: Any quality supplement intended to support weight management is promoted in conjunction with healthy diet and exercise. If Americans consistently choose healthy diet, exercise and natural nutrition, not only will they lose weight, they will elevate their overall state of health. Such a scenario is Big Pharma’s worst nightmare. If America is happy, energetic and at a healthy weight, there is no need for synthetic medications—and Big Pharma makes no profits.

So how do you feel about Big Pharma’s latest gambit to undermine natural nutrition? If the petition to limit weight-management nutrition fills you with outrage, start your own petition supporting natural health. Let your elected officials know how you feel! Another way to make your voice heard is through the dollars you spend: Patronize independent natural health food stores and purchase safe, natural nutritional supplements from companies that have no pharmaceutical industry ties. To join with other people who feel as you do, become a member of the Nutritional Health Alliance (NHA) health freedom advocacy group. For the sake of health freedom, join the NHA today!

Reprinted with permission: Nutritional Health Alliance (NHA)

©2012 An Inconvenient Woman. All Rights Reserved.

Synthetic drug treachery has plummeted to a new ethical low with a disturbing development that may grant Big Pharma eternal immunity from consumer lawsuits. This most recent affront to justice involves a birth-control drug with side effects believed to have caused the deaths of 40 women, along with thousands of additional heart attacks and strokes. About 3,000 women subsequently united in a class-action lawsuit against the birth-control drug manufacturer. As the lawsuit takes shape in an Ohio federal court, this drug maker has taken a position that is a staggering example of Big Pharma’s bottomless greed and nonexistent morality.

Thanks to a legal concept called pre-emption, approved by the US Supreme Court earlier this year, the birth control manufacturer has a strong defense against the lawsuit: Since the FDA approved the drug, the pharmaceutical manufacturer that created the drug claims it should not be held liable for any of the deaths, heart attacks, strokes or other maimings the drug may have caused. Shockingly, legal experts believe this defense might be bulletproof—setting up a distressing potential precedent where Big Pharma may never be held accountable for the dangerous synthetic drugs it unleashes on an unsuspecting public.

Dangerous Deceit

How did this travesty happen in the first place? The estrogen used in birth-control drugs, when delivered at levels that are too high, carries the risk of provoking blood clots—which in turn cause strokes and heart attacks. The birth-control drug named in the lawsuit, which comes in the form of a patch, was marketed as a way to deliver less estrogen than a pill while still remaining effective. The FDA approved this patch in 2001.

The truth came out years later: An independent organization found that the patch in question delivered more estrogen—not less— than its pill counterparts. The patch’s manufacturer was well aware of the dangers associated with high estrogen levels. Unfazed, they not only submitted the drug to the FDA for approval, but deceptively labeled it as having a much lower level of estrogen than was actually the case. After four years on the market and thousands of serious adverse events reported—including deaths—the FDA finally issued a formal warning about the birth-control patch.

Drug Déjà Vu

Does this scenario sound ominously familiar? It is, to quote Yogi Berra, déjà vu all over again: A dangerous drug is released to the public, thousands of people are injured or killed as a result of taking it and then the FDA issues its warning—far too late for those who have been devastated by horrible side effects. Despite its now-legendary drug approval failures— and despite its thinning resources—the FDA has inexplicably decided to continue focusing a great deal of its regulatory energy on the one arena that’s promoting health without dangerous side effects: nutritional supplements.

So how do you feel about Big Pharma’s refusal to take responsibility for its dangerous medications? Has your confidence in the FDA’s drug-approval process faltered? Speak your mind and make your voice heard! Tell your elected officials that you want the FDA to leave nutritional supplements alone and instead focus its regulatory resources on Big Pharma! Rage against the preemption that may enable Big Pharma to release dangerous drugs without fear of repercussions!

In addition, patronize independent natural health food stores and purchase safe, natural nutritional supplements from companies that have no pharmaceutical industry ties.

Source: The Nutritional Health Alliance (Reprinted with permission)

The Nutritional Health Alliance is one of the most active political organizations in the nutritional health community, founded in 1992 in Santa Ynez, California. Organized by consumers, health care professionals, retailers, distributors, supplement manufacturers, mail order and multilevel marketing firms, and industry trade and consumer publications, the NHA became the much-needed umbrella organization to bring together the various constituents of the natural products industry in a single, powerful voice that would be heard by Washington policymakers and regulators.

There is plenty you can to do get involved and support the NHA. Join NHA now and communicate on NHA forum, browse through the NHA PDF Library, view the NHA press and videos or search NHA’s related links to gain further knowledge on laws that affect your rights to buy vitamins and supplements.

Let your voice be heard, write to your Congressperson or view NHA current activities to find out ways to keep your right to buy vitamins in your own hands… Don’t let Congress and the FDA take your vitamins away!

For the sake of health freedom, join the Nutritional Health Alliance (NHA) health freedom advocacy group today!

©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.

“Should be required reading for ALL women and girls!”

“Selling Sickness pulls back the curtain on the politically-charged (and financially inspired) machinations of the pharmaceutical industry and explains the mass manipulation. It’s a very disturbing book, but also well documented, well researched and utterly fascinating. Read it and weep – for America’s health care system.”

— Rosemary Thornton, Amazon.com Review

Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All into Patients

This accessible study about the collusion between medical science and the drug industry emphasizes how drug companies market their products by either redefining problems as diseases (like female sexual dysfunction) or redefining a condition to encompass a greater percentage of the population.

Moynihan, a health journalist for the New England Journal of Medicine and the Lancet, and Cassels, a Canadian science writer, note, for instance, that eight of the nine specialists who wrote the 2004 federal guideline on high cholesterol, which substantially increased the number of people in that category, have multiple financial ties to drug manufacturers.

Science and medicine writers Moynihan and Cassels conjecture that most Americans believe, based on information gleaned from a deluge of pharmaceutical-company advertisements, that conditions such as hypertension, high cholesterol, menopause, and chronic constipation are bona fide diseases.

They quote reputable medical experts, however, who refute such understandings. What’s more, they suggest that billions of precious and diminishing health-care dollars are squandered treating those non-diseases of healthy, wealthy Americans and would be better spent treating the legitimately sick poor and fighting the international AIDS epidemic.

Quoting former Merck CEO Henry Gadsen — who, in a 1976 Fortune article, confessed that, “…it had long been his dream to make drugs for healthy people. Because then, Merck would be able to sell to everyone”

— they lay the blame for the misdirected billions at the feet of just such pharmaceutical giants as Merck. Finally, they counterpoint glossy pharmaceutical ad campaigns with alternatives that consumers may consider before asking their doctors for prescription drugs they saw touted on TV.

Physicians now routinely prescribe cholesterol-lowering pills (statins) that may have perilous side effects, when many people could lower their risk of heart attack with less costly and dangerous steps, such as exercise and improved diet. Through aggressive merchandising, funding of medical conferences and expensive perks, drug companies win doctors over to diagnosing these “diseases” and prescribing drugs for them.

Much of this territory has been covered by several books in the past year most notably Marcia Angell’s, The Truth About the Drug Companies; but this is still an excellent exposé of 10 or more examples of manufactured or exaggerated illness, from adult attention deficit disorder to osteoporosis.

If this is your first exposure to the secret life of Big Pharma, their secret ownership of some patient support groups, their control of much of Continuing Medical Education, the capture of the FDA and other agencies through Pharma’s legendary lobbying machine will shock and sadden you. Every American needs to understand how Big Pharma’s use of public relations firms to create fear of some normal condition, followed by overwrought promotions of drugs and the systematic concealment of drug side-effects manipulates them and is a primary factor in the spiraling cost of health care. Even if you know about this American disgrace, there are many aspects that may be new to you, so read this book.

Then do something!

Don’t Get Angry — Get Active!

You can start by doing independent research on any drug recommended by your health care professional.

It’s your body and you are ultimately responsible for what you put in it or on it.

©2012 An Inconvenient Woman. All Rights Reserved.

The FDA announced today that it is considering whether to make more information available to the public from advisory committee members’ financial disclosures. The panels make recommendations to the agency on allowing drugs and medical devices to go on the market.

The new guidelines will be designed to, “make sure that the current system is rigorous, consistent and transparent,” Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, in a telephone interview. FDA decisions about who can serve on advisory committees probably won’t change significantly under the new guidelines, he said.

Members of Congress and public interest groups have criticized the FDA for appointing doctors and scientists who have financial or other relationships with the companies whose products they are asked to consider. The U.S. House has approved legislation that seeks to prevent the FDA from allowing those with conflicts to serve on advisory panels.

The FDA’s planned changes don’t go far enough to achieve, “unconflicted FDA leadership,” said Steven E. Nissen, president of the American College of Cardiology, in a panel discussion in Washington today sponsored by the Center for Science in the Public Interest. “The American people no longer trust the FDA to protect their health.”

Recruiting Panel Members

In a draft of his speech to the group today, Gottlieb said House legislation would create problems for the FDA. The measure might hamper the agency’s ability to, “put experience and expertise as the paramount criteria when recruiting members to serve on these committees,” according to the draft remarks.

“We issue waivers to some people who have what we deem to be relationships that, while significant enough to warrant disclosure, are not deemed to be the kind that, after properly disclosed, will affect their judgment or impartiality or outweigh the benefits of the contribution offered by their participation,” Gottlieb said in the draft.

The FDA staff makes decisions on whether conflicts of interest are serious enough to prevent people from serving on advisory committees. New guidelines would be used in making those decisions.

A study published in the April 26 Journal of the American Medical Association found that 28 percent of advisory panel members and consultants had a financial link to either a drug-maker whose product was being considered or a competitor. The most common ties were payments for consulting, grants or investments, according to the study by Public Citizen, a Washington-based group that is critical of the FDA’s oversight.

A February 2005 analysis by the Center for Science in the Public Interest found that 10 of 32 advisory panelists considering the safety of a class of pain medications similar to Merck & Co.’s withdrawn Vioxx had financial ties to the drugs’ makers.

Had those panelists been excluded, the advisory committee’s recommendation to leave the products on the market would have been reversed, according to the study by the Washington-based center, which focuses on nutrition and food safety.

The FDA needs more funding to replace fees that drug-makers pay to have their applications for approval reviewed because the payments make the agency dependent on the companies, said Nissen, who is chairman of cardiovascular medicine at the Cleveland Clinic.

Source: Bloomberg.com

To contact the reporter on this story:

Justin Blum in Washington at  jblum4@bloomberg.net.

©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.