Archive for category FDA
by: Alicia Martin
July 28, 2012
About two-thirds of women in the United States take one or more prescription medications during pregnancy, many of which the potential effects on a fetus are unclear. In developed countries, birth defects are the leading cause of infant mortality. The complex melange of factors that contribute to a healthy pregnancy make it very difficult to specifically identify causal factors, but it is widely agreed upon that taking medication during pregnancy can result in fetal damage.
Use of Medication During Pregnancy a Dangerous Decision
In 1979, the United States Food and Drug Administration introduced a system to classify pharmaceuticals based on fetal risks. The two highest categories of risk in this system are ‘Category X,’ where fetal abnormalities could occur, and/or there is positive evidence of human fetal risk based on adverse reaction data, and the risks involved in the use of medication during pregnancy clearly outweigh potential benefits. Then there is ‘Category D,’ where it is claimed that the use of the drug will provide more benefits than risks, despite positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. Needless to say, pharmaceutical drugs should be avoided, especially while pregnant.
An analysis of almost 13,000 doctor visits made by women of childbearing age between 1998-2000 showed that one out of every thirteen was on a class D or X medication, and given the steep and steady increase in prescriptions for psychotropic drugs in the past decades, it’s likely that this number is also increasing.
In addition to these medications which are known to pose a risk, the data on many other prescription drugs is limited at best. According to Dr. Cheryl Broussard, Epidemiologist with the Centers for Disease Control and Prevention, most medications have not been adequately evaluated for use during pregnancy, and one study showed that more than 90% of medications approved by the US Food and Drug Administration (FDA) from 1980 to 2000 had insufficient data to determine the risk in human pregnancy.
Thursday, July 26, 2012
by: Mike Adams
[NaturalNews] In the aftermath of the Aurora, Colorado Batman movie theater shooting, President Obama chimed in on the gun control debate yesterday, saying, “Every day, the number of young people we lose to violence is about the same as the number of people we lost in that movie theater. For every Columbine or Virginia Tech, there are dozens gunned down on the streets of Chicago or Atlanta…” (http://www.washingtontimes.com/news/2012/jul/25/obama-calls-measures-…)
What he didn’t say, however, is that every day 290 people are killed by FDA-approved prescription drugs, and that’s the conservative number published by the Journal of the American Medical Association.
As no one seems to believe these numbers are real, I’ll quote the source: The Journal of the American Medical Association (JAMA) Vol 284, No 4, July 26th 2000, authored by Dr Barbara Starfield, MD, MPH, of the Johns Hopkins School of Hygiene and Public Health.
That study, which is twelve years old — and drug deaths have risen considerably since then — documents 106,000 deaths per year from the “adverse effects” of FDA-approved prescription medications.
To reach this number from outbreaks of violent shootings, you’d have to see an Aurora Colorado Batman movie massacre take place every HOUR of every day, 365 days a year.
If a massacre of people using slugs of lead is bad, why is a massacre of people using deadly chemicals perfectly acceptable?
A medical massacre that dwarfs the number of deaths from shootings
No one in Washington talks about prescription drug deaths. There are no sobbing victims shown on the evening news. This “chemical massacre” happens quietly, behind closed doors. Yet to achieve this level of mass death in the world of plane crashes, for example, you’d have to see a jumbo jet airliner crashing into the ground once a day, every day of the year.
But that’s only the beginning of the mass death caused by modern medicine, where greed-driven doctors are routinely bribed by the drug giants (http://www.naturalnews.com/036510_doctors_bribes_drug_companies.html) and thereby make the “Joker” James Holmes look like a boy scout by comparison. As NaturalNews previously revealed, just one company — GlaxoSmithKline — had a bribery network of 49,000 doctors who received financial kickbacks to prescribe more Glaxo pharmaceuticals to patients.
According to the report Death by Medicine, by Drs. Gary Null, Carolyn Dean, Martin Feldman, Debora Rasio and Dorothy Smith, the medical establishment kills 783,936 people in the United States every year. (http://www.lef.org/magazine/mag2004/mar2004_awsi_death_02.htm)
Those deaths include:
• 106,000 Americans killed from drug side effects
• 115,000 Americans killed from bedsores
• 98,000 Americans killed from medical error
• 88,000 Americans killed from infections
• 32,000 Americans killed from surgery
• 37,000 Americans killed from unnecessary procedures
… and so on. See the source link, above, for the rest of the numbers.
The bottom line total comes to 783,936 deaths every year from “conventional” medicine (drugs and surgery medicine).
You are 6200% more likely to be killed by your doctor than by a shooter
According to the CDC’s numbers from 2007, the total number of homicide shooting deaths in the United States each year is roughly 12,600 (Xu, Jiaquan; Kenneth D. Kochanek, Sherry L. Murphy, Betzaida Tejada-Vera (2010-05-20). “Deaths: Final Data for 2007″ (PDF). National Vital Statistics Reports (CDC) 58(19): 11. Retrieved 2011-04-07.)
This means that your risk of being killed by your doctor is 62 times higher than the risk of being killed by a shooter. Put another way, that’s a 6200% higher risk.
It seems that before we even think about the issue of gun control, we need a national debate on DOCTOR control.
After all, when doctors inadvertently kill people by prescribing deadly chemotherapy cocktails or deadly prescription drugs, they don’t even get arrested for it! But they do get financial kickbacks, exotic vacations paid by drug companies, free travel, free meals and other perks of being a Big Pharma whore. Plus, they’re free to go on killing other people, over and over again. While doctors obviously don’t intend to kill people, they nonetheless keep doing so as long as they get their bribes, kickbacks and perks. (http://www.naturalnews.com/036417_Glaxo_Merck_fraud.html)
If Obama really wanted to protect Americans from being killed, he’d call for restrictions on the prescribing of deadly pharmaceuticals. But don’t hold your breath on that one, because when it comes to actually protecting the American people from medical massacres, or GMOs, or toxic fluoride in the water supply, the real Joker is Obama himself.
July 25, 2012
The Documentary below by Gary Null exposes many of the tyrannical ways in which the FDA has carried out its attack on the populace’s food rights. It leaves no doubt as to how incisive, dangerous & purely controlling this agency has become over time. The fact that the FDA has carried out an all-out assault on many beneficial foods & supplements that would aid people’s health is beyond disturbing.
As an adjunct to the documentary below, for those seeking additional information regarding the nefarious ways of the TSA please read:
July 25, 2012
by: Dr. Mercola
July 24, 2012
According to the Council for Responsible Nutrition, 69 percent of American adults take supplements. But are supplements dangerous? The UK-based, international campaign group, the Alliance for Natural Health International (ANH-Intl) recently revealed data1showing that compared to supplements, an individual is:
- Around 900 times more likely to die from food poisoning
- Nearly 300,000 times more likely to die from a preventable medical injury during a UK hospital stay, which is comparable to the individual risk of dying that active military face in Iraq or Afghanistan
Additionally, the data shows that adverse reactions to pharmaceutical drugs are:
- 62,000 times more likely to kill you than food supplements
- 7,750 times more likely to kill you than herbal remedies
The data, which was collected from official sources in the UK and EU, demonstrate that both food supplements and herbal remedies are in the ‘super-safe’ category of individual risk – meaning risk of death from their consumption is less than 1 in 10 million. The group has created an excellent graphic2 showing your relative risk of death from a variety of activities. Besides drugs and hospital injuries, you’re also more likely to die from being struck by lightning or drowning in your bathtub than having a lethal reaction to herbs or supplements…
According to the featured article on NewHope360.com3:
“ANH-Intl executive and scientific director, Robert Verkerk PhD, hailed the figures as shedding new light on the vexed question of natural healthcare’s safety. “These figures tell us not only what activities an individual is most or least likely to die from, but also what the relative risks of various activities are to society as a whole. It puts some real perspective on the actual risk of death posed by food supplements and herbal remedies at a time when governments are clamping down because they tell us they’re dangerous.
… According to Dr Verkerk, the new figures should help to pressure UK and European authorities to reduce regulatory burdens on natural health products.”
With a Super-Safe Track Record, Why are Supplements Under Attack?
Vitamins, minerals and herbal supplements have a tremendously safe track record, yet they are often singled out as being potentially dangerous by government agencies like the US Food and Drug Administration (FDA). This – the notion that dietary supplements are unsafe — was the premise behind the FDA’s Draft Guidance on New Dietary Ingredients (NDI), which would have required the supplement industry to prove the safety of natural ingredients that, in many cases, have been on the market and used safely for decades!
Fortunately, public outcry made the agency agree to take another look at their proposed guidance and to issue a revised draft4. It’s still not known when the revisions might be completed.
The original NDI draft essentially claimed dietary supplements are unsafe and must be carefully tested in order to “protect consumers.” The proposed safety thresholds even exceeded those required by pharmaceutical drugs — despite extensive toxicological data showing supplements are FAR safer than drugs. As detailed above, drugs are 62,000 times more likely to kill you than supplements! Why on earth would supplements need more stringent safety thresholds than drugs?
It’s an obvious attempt to eliminate competition for the drug industry.
Data from the United States fully corroborates the featured UK data. For example, according to the latest data from the US National Poison Data System (2010 report)5, NO deaths were attributable to vitamin and mineral supplements that year. And, as noted byOrthomolecular Medicine News Service last year6, Americans easily take more than 60 billion doses of nutritional supplements every year, and with zero related deaths this is an outstanding safety record:
“Well over half of the U.S. population takes daily nutritional supplements. Even if each of those people took only one single tablet daily, that makes 165,000,000 individual doses per day, for a total of over 60 billion doses annually. Since many persons take far more than just one single vitamin or mineral tablet, actual consumption is considerably higher, and the safety of nutritional supplements is all the more remarkable.Over 60 billion doses of vitamin and mineral supplemnts per year in the USA, and not a single fatality. Not one. If vitamin and mineral supplements are allegedly so ‘dangerous,’ as the FDA and news media so often claim, then where are the bodies?”
The Drug Industry is the Real Health Threat
In striking contrast, drugs are known to cause well over 125,000 deaths per year in the US when taken correctly as prescribed – yet the FDA allows fast-track approvals and countless new additions of poorly tested drugs to the marketplace that must later be withdrawn due to their lethal consequences.
It is simply incomprehensible that any rational approach would seek to vilify supplements over drugs when the data in no way, shape or form supports it. The most likely motive for this position is financial greed that can put your life in jeopardy. According to the US National Poison Data System7 the following drug categories are among the most lethal:
- Analgesics, sedatives, hypnotics, and antipsychotics
- Cardiovascular drugs
- Acetaminophen combinations
Slightly lower down on the list you find drugs like muscle relaxants, anti-inflammatory drugs, hormones, antacids, anticoagulants, and antihistamines.
by: Sayer Ji, Founder
July 23, 2012
The scientific literature indicates that there are at least two dozen adverse health effects linked to exposure to mineral oil, a crude oil derivative. New research indicates these fat-soluble hydrocarbons are accumulating to disturbing levels in our bodies, and affecting newborns by contaminating breast milk.
How did they get there? Mineral oil is legally allowed to be added to our foods, drugs and cosmetics, where they accumulate in our bodies over time, with the highest concentrations found in our fat deposits. One autopsy study performed in 1985, revealed that 48% of the livers and 46% of the spleens of the 465 autopsies analyzed showed signs of mineral-oil induced lipogranuloma (a nodule of necrotic, fatty tissue associated with granulomatous inflammation or a foreign-body reaction around a deposit of an oily substance), indicating just how widespread pathological tissue changes associated with exposure really are.
In the United States, the FDA has approved mineral for use in cosmetic products, as well as a food additive up to 10 mg/kg a day. For a 150 lb adult (68.03 kilograms) this is the equivalent of 680 milligrams a day, or 248 grams (over half a pound!) a year.
Friday, July 20, 2012
By: J. D. Heyes
[NaturalNews] Having to deal with the mental and physical pains of cancer is bad enough, but it’s worse when you have to fear the medicine used to treat it.
Hospira, the world’s leading provider of injectable drugs and infusion technologies, announced in June that it will recall four of its cancer drugs and other medications both in the United States and from around the world – the fourth month in a row the company has had to warn the healthcare industry of issues related to its products.
In a joint release with the Food and Drug Administration, Hospira blamed the glass supplier for the injectables in recalling 19 lots of carboplatin, cytarabine, paclitaxel and methotrexate, which were shipped between September 2011 and April of this year. According to the release, vials of these drugs have been discovered with “visible particles embedded in the glass located at the neck of the vial.”
Glass particles in the medicine, in other words.
“In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms,” said the joint statement.
Drugs in U.S., abroad recalled
Daniel Rosenberg, a spokesman for Hospira, told the Pharma Web site FiercePharmaManufacturing, in an email: “Hospira has not received any reports of adverse events related to these lots. The root cause is a supplier glass defect, and we have taken corrective action to prevent this from occurring again. For U.S. customers, replacement product from other lots is available and no drug shortages are expected as a result of this recall.”
In addition, the company has said recently it was recalling drugs from a number of other nations ranging from Canada to Norway, Australia and Vietnam, reports said. Those global recalls don’t include cytarabine; however, but do include other drugs such as heparin, desferrioxamine, oxaliplatin, fluorouracil and epirubicin.
In his email, Rosenberg said it’s possible that some countries could experience temporary shortages of the drugs but added, “In most cases, we will have replacement stock available, and we don’t anticipate major disruptions for the majority of our overseas customers.”
The Pharma Web site noted that shortages stemming from drug-maker manufacturing problems have been a major issue over the past couple of years, particularly at Hospira, which the site says “has found itself in the middle of it.” The company is one of four other generic medication producers named in a House committee report recently that are linked to grave shortages of drugs in the United States, due to FDA actions requiring each to correct quality control issues on their production lines.
Hospira has also borne the brunt of a new legal strategy: Patients or their families filing suit against drug makers who say a shortage of medications they were taking worsened their medical conditions and, in some cases, even led to death.
by: Susanne Posel
July 20, 2012
The Food and Drug Administration (FDA) has approved Gilead Sciences’ Truvada, the first pharmaceutical drug to prevent the virus that causes AIDS.
Some of the senior members of Gilead Sciences include:
- John C. Martin, Chairman and Chief Executive Officer, who served on the Centers for Disease Control/Health Resources and Services Administrations Advisory Committee on HIV and STD Prevention and Treatment and was a member of the Presidential Advisory Council on HIV/AIDS and worked for competitors Bristol-Myers Squibb and Syntex Corporation
- Robin L. Washington, Senior Vice President and Chief Financial Officer who was a former accounting analyst for the Federal Reserve Bank of Chicago
- Kevin Young, Executive Vice President, Commercial Operations, who was appointed Commander of The British Empire for his service to the healthcare and pharmaceutical industries
Margaret Hamburg, FDA commissioner, released a statement saying that the approval by the FDA “marks an important milestone in our fight against HIV.”
Marketed as a preventative for people who at high risk of contracting HIV through sexual activies, Turvada is supported by public health advocates that believe this pill will slow down the spread of HIV. In America it is estimated that 1.2 million people have HIV. With this new antiviral drug, it is proposed that 240,000 HIV carriers will not be able to continue to spread the disease.
Gilead Sciences combined two separate drugs to create Truvada. The genetically engineering of the preventative is praised by the FDA to answer the assumption that condoms are not effective. The pharmaceutical corporations are working hard to convince the general public that their drugs are the only answer to our problems; whether with regard to healthcare or psychology or simply controlling social behavior as with addiction vaccines .
The inception of HIV/AIDS began in the late 1970’s when the World Health Organization (WHO) went into Africa under a small pox vaccine initiative . Suddenly, in 1981, the first recorded incident of HIV was “discovered” in the same places where WHO had conducted the small pox vaccine campaigns.
by: Dr. Mercola
July 18, 2012
The “C” word; probably the most feared word there is in healthcare. Just the mere mention of cancer conjures up images of death and despair. Cancer screening like annual mammograms is the conventional go-to “prevention” strategy. But researchers increasingly agree that mammography is ineffective at best, and harmful at worst…
In November of 2009, the U.S. Preventive Services Task Force, a federal advisory board, revised their cancer screening recommendations, saying annual mammograms weren’t necessary for women under age 50 and that screenings were recommended only every two years after that1.
The panel based the new guidelines on data indicating that mammography does more harm than good when used on younger women.
Besides the fact that the ionizing radiation delivered during mammography can cause cancer in and of itself, overdiagnosis of cancer, as well as misdiagnosis, has been shown to be a significant problem plaguing this form of cancer screening.
According to a Norwegian study, published in April of this year2, as many as 1 in 4 women are consistently overdiagnosed with breast cancer that, if left alone, would never have caused them any harm.
Whistleblowers Claim FDA Approved Dangerous Mammography Equipment
On July 15, the New York Times revealed that the FDA has engaged in an intense spying campaign against five whistleblowers within the organization3, as well as “FDA opponents” deemed to be in collaboration with the whistleblowers.
According to the NYT:
“What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort.
Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.
… The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the FDA over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.”
As a longtime critic of mammograms, I’m familiar with the kind of harassment the FDA can dish out, so it does not surprise me the agency would stoop so low as to spy on their critics.
How can the FDA justify spying on and harassing their own scientists—professionals hired to assess the safety of devices such as mammograms—just because these employees found serious health threats that the agency would rather continue to ignore in order to protect their industry clients? It’s completely unconscionable and there’s no good defense.
Good News: Fewer Younger Women are Getting Mammograms
While U.S. Preventive Services Task Force’s new guidelines initially ignited fierce protests from cancer advocacy groups, mammography rates for women in their 40s are declining4.
According to recent findings by the Mayo Clinic5:
“Presented last week at an annual research meeting, the study analyzed data from 100 health plans across the U.S. Looking specifically at the number of mammograms performed from January 2006 to December of 2010, researchers found a drop of nearly 6 percent among women ages 40 to 49.
Meanwhile, the number of mammograms among women ages 50 to 64 remained steady, despite the same panel’s recommendation that women need only be screened every two years.
“We applaud this news,” says ACSH’s Dr. Elizabeth Whelan. She notes that, while too many people still believe there’s no harm in getting a mammogram, the task force study demonstrated that this is clearly not the case. “We now have reason to hope that the influence of the USPSTF guidelines will only increase, meaning that we’ll see a decrease in the number of women who unnecessarily undergo procedures such as radiation, mastectomy, or lumpectomy.”
Cancer Overdiagnosis, Still a Serious Concern
According to Dr. Otis Webb Brawley, chief medical officer of the American Cancer Society, the term “overdiagnosis” in cancer medicine refers to6:
“… a tumor that fulfills all laboratory criteria to be called cancer but, if left alone, would never cause harm. This is a tumor that will not continue to grow, spread and kill. It is a tumor that can be cured with treatment but does not need to be treated and/or cured.”
The problem, according to a report by CNN published back in April, is related to advances in technology7. As mammograms are able to detect tinier and tinier spots in the diagnostic films, the possibility overtreatment increases exponentially when overzealous clinicians insist that more tests, including invasive MRIs with dye and painful biopsies, be done on women who have the misfortune of having a tiny spot in their X-ray.
Concerns about overdiagnosis of both breast- and prostate cancer have increased over the years. (According to Dr. Webb Brawley, an estimated 60 percent of prostate cancers are also harmless tumors that do not need treatment.)
The findings from Norway support several previous studies, such as the Cochrane Database review from 20098, which found that breast cancer screening led to a 30 percent rate of overdiagnosis and overtreatment, which actually increased the absolute risk of developing cancer by 0.5 percent. The review concluded that for every 2,000 women invited for screening throughout a 10 year period, the life of just ONE woman was prolonged, while 10 healthy women were treated unnecessarily. Another 200 women undergo psychological stress and trauma for several months due to false positives.