By Dr. Mercola
The proposed 2014 budget for the US Food and Drug Administration (FDA) is a hefty $4.7 billion—"a true bargain among federal agencies," according to FDA Commissioner Margaret Hamburg.1
In my humble opinion, this has to be one of the biggest health delusions of the 21st century. The sad fact is that this federal agency is responsible for an ever-expanding list of policy decisions that favor big industry at the expense of public health.
The FDA's approval stamp has deteriorated to become virtually meaningless as far as assessing the safety and effectiveness of any given product is concerned.
Case in point: In today's featured article,2 Mark Krause, a cytotechnologist, discusses what he believes to be fraud resulting from "falsely advertised and/or dysfunctional products approved by a scandal-ridden Food and Drug Administration."
A cytotechnologist is a lab technician who screens PAP smears—a diagnostic test that checks for changes in the cells of your cervix. The test is used to detect potentially pre-cancerous and cancerous lesions, indicative of cervical cancer.
Updated guidelines from the US Preventive Services Task Force call for women to undergo PAP screening once every three years, beginning at age 21 and ending around age 65. Krause writes:
"Currently most pap smears are no longer smears, they are monolayered preparation. The cellular material is dropped into a vial containing an alcohol solution. Some mucous and blood are dissolved and debris is removed.
The sample is deposited on a slide in a single cellular monolayer. The great majority of cytotechs like it, including myself, as it is easier to read. Apparently the major reason it is in place is because of higher profitability."
Problems and Profits of PAP Smears
The monolayer PAP test is advertised as "extraordinarily more accurate than a conventional pap smear," according to Krause. One company selling the test claims its accuracy is anywhere from 100 to 230 percent greater than its predecessors. However, Krause points out, other studies, and experiences at his own lab, refutes such claims. According to the featured article:
- A 2009 Dutch-Belgian study published in the Journal of the American Medical Association found no increase in accuracy
- The US Preventive Services Task Force also found no differences in accuracy between the tests
- One Australian study found an increase of 12 percent
The lab Krause works in has seen modest accuracy increases of five to 10 percent, leading him to assert that:
"It appears that the manufacturer has major credibility issues with honesty in advertising. The apparent deceptive advertising may be deliberate for the monolayer pap may have really been designed for an FDA approved, computerized microscope.
One is advertised as being approximately 20-45 percent more accurate than a cytotech alone. Our lab did not see any accuracy increases. Studies in Australia, Ireland and USA concluded the same. More dishonest advertising? Apparently the device is highly profitable. It significantly increases the cost of the PAP test."
More disturbingly, Krause asserts that he and his colleagues were "alarmed" once the lab acquired the computerized microscope because the device tended to miss abnormal cell changes when those changes occurred in large clusters. It also had a tendency to "zero in on air bubbles, chips in the glass, dirt, dark colored benign cells or just blank space."
How did such a shoddy product get past the scrutiny of the FDA, they wondered? Krause goes on to cite various news articles revealing major problems within the agency, many of which I've addressed in this newsletter through recent years, such as:
- In 2008, Readers Digest claimed "the FDA is the best agency the pharmaceutical industry can buy," and that "the agency is lurching from one disaster to the next, one shocking lapse after another."
- Two years ago, Money Watch wrote that the agency is "riddled with politics, conflicts of interest and outright corruption."
- Just last year, the media exposed how the FDA had organized a massive spying operation involving the unit that investigates medical devices, including those for cancer screening. According to a whistleblower lawsuit, FDA scientists claim the agency approved colonoscopy and mammography devices knowing they delivered potentially dangerous doses of radiation.
Is the FDA Really Looking Out for Your Health and Wellbeing?
There are so many problems with the FDA it could easily fill an entire book. Let me list just a handful of them here for you. Their failures to protect you include whammies like:
- The approval of the antibiotic Ketek, despite the fact that the study was so fraught with fabricated data it led to arrests and prison terms
- The deadly Vioxx debacle, which was followed by the deadly Avandia scandal
- Antidepressants found to incite murderous and suicidal episodes
- Lead-tainted toys
- Toxic pet food
It should be clear to anyone who has followed the numerous scandals the FDA has created over the past several years that the agency's main concern is not to protect you -- they're working to protect the pharmaceutical industry. Krause writes:
"In their book, The Battle Over Health Care, authors Gibson and Singh point out that of the high-risk medical devices recalled by the FDA, 75 percent were never evaluated. Some 20 percent of cardiac defibrillators were recalled and hundreds died due to malfunctions. Many cytotechs suspect that the computerized microscope was rubber stamp approved because of some combination of corporate financial hooliganism and FDA absentmindedness.
...The computerized microscope appears to be a typical case of a substandard, fraudulent medical product getting past a sleeping and/or corrupt governmental watchdog. Its use constitutes a cavalier disregard for basic bio-medical ethical standards that is totally cynical and leaves much to be said for the quality of the character of involved corporate elites, their sales representatives and laboratory managers alike."
Choosing PAP Smears Over Vaccination
Since we're on the topic of PAP smears, we must comment on another cervical cancer "prevention" strategy: HPV vaccines. I want to remind you that opting for an HPV vaccine over getting regular PAP tests would, for most, be an unwise decision. Especially when you consider that the HPV vaccine can raise your or your daughter's risk of precancerous cervical lesions by nearly 45 percent. This information was presented by Merck to the FDA prior Gardasil's approval.
According to Merck's literature,3 you actually increase your risk of precancerous lesions, or worse, by 44.6 percent if you've been exposed to HPV 16 or 18 prior to taking the vaccine. Furthermore, Merck's research indicates that Gardasil may also provide 'cross-protection' against other strains of HPV that are closely related to HPV 16 and 18.4 This means prior exposure to these other strains could potentially pose an increased risk for cervical cancer as well, if combined with vaccination.
Yet nowhere will you find any warning about the potential of increasing your risk of the very cancer this vaccine purports to protect you against, should you have already been exposed to certain HPV strains.
This could indeed be a potential health hazard that no one is talking about, let alone making parents fully aware of before vaccinating their daughters. And the FDA isn't saying a word about it either, even though they were given the information prior to approval. The FDA neither recommends screening for HPV prior to vaccination, nor has it demanded that a warning be included in the package insert...
Were PAP Smear Guidelines Changed to Promote HPV Vaccination Instead?
To paint Gardasil or Cervarix, the two HPV vaccines, as vaccines that prevent cancer is borderline, if not outright, fraudulent. For those who are still unaware, the HPV vaccine only contains two strains of HPV associated with cancer (HPV-16 and HPV-18). But there are more than 100 different strains of HPV in all, and about 15 of them have been associated with development of cancer IF HPV infection persists over a long period of time. In more than 90 percent of all cases, however, the infection resolves on its own within two years and does not lead to any health complications.
Furthermore, cervical cancer is actually quite rare, and scaring young girls into taking the vaccine is, in my opinion, doing them a gross disservice. Despite an estimated six million new cases of HPV in the US each year,5 only 11,000 women are diagnosed with cervical cancer, about 3,800 of which end up dying from the disease—hardly the kind of health threat deserving of a mass vaccination campaign.
According to a 2008 study,6 in order for the HPV vaccine to be cost-effective—due to the low incidence of cervical cancer in the US—a majority of 11- and 12-year-old girls have to be vaccinated. But that hasn't happened. Only about 34 percent of US girls had completed all three shots at the time of the study, and vaccine uptake is still lagging far behind expectations. According to the authors, one of the ways to improve the cost-effectiveness of the vaccine would be to cut back on getting Pap smears – the very test credited for making cervical cancer so low in this country – from every year to no more than every three years.
As if on cue, the following year, in 2009, the American College of Obstetricians and Gynecologists announced7 that women in their 20s don't need more than one PAP screening every other year. Women over 30 were advised to wait three years between screenings. In 2012, the US Preventative Services Task Force followed suit, issuing revised guidelines on PAP smears that call for one PAP test every three years, from the age of 21 until 65.
The question is, why would they do this when it's been proven that the reason cervical cancer is so low in the US and other developed nations is because the rate of PAP testing is so high? The PAP test is a tool with a track record of efficacy. Studies have shown that most cervical cancers in the developed world occur in women who have not had a PAP test in the past five years, or who have never had one at all.
Remember, certain strains of HPV can lead to cervical cancer if left untreated for long periods of time. The PAP test can identify abnormalities and prevent cancer by treating the infection early. So why would health officials want to "fix" something that's not broken? Are they merely trying to steer you toward a more profitable alternative? It's worth noting that according to one of the most recent studies on HPV infection and HPV vaccine uptake, the data clearly shows that unvaccinated girls had the best outcome.
Safer, Healthier Ways to Avoid HPV
The good news is there are far safer, healthier ways to avoid HPV. First, realize that HPV infection is exacerbated by:
- Early sexual activity
- Having multiple sex partners
Research has shown that women whose partners wear condoms during vaginal intercourse are 70 percent less likely to become infected with HPV,8 which is a FAR greater level of protection than you can get from the HPV vaccine. So, teaching your child about making healthy choices and practicing safe sex is a start toward avoiding HPV.
Additionally, as with all diseases, an impaired immune system and suboptimal nutrition can also make you far more susceptible to infection, such as HPV. Vitamin D deficiency is a major factor that will depress your immune function, leaving the door open to invading viruses of all kinds. Other lifestyle factors that can depress your immune system, alone or in combination, include:
- Being insulin and leptin resistant by eating excessive amounts of sugar/fructose and grains
- Lack of sleep
- Insufficient exercise
- Using ineffective strategies to address stress
FDA Actively Thwarts Serious Safety Investigations
There's no telling how many ineffective and/or dangerous drugs and medical devices have been approved and ushered into market through sheer intimidation and bullying, either by pharmaceutical companies or FDA management.
Perhaps even more shocking are the revelations that some of the internal rules and regulations of the FDA are clearly designed to thwart serious safety reviews from the get-go. Ronald Kavanagh, a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008, spoke out last year about how the agency bypassed or ignored safety issues on major drugs approved during his employment...9
Stories and statements from the likes of Kavanagh, Krause, and many others, help paint a very clear picture of what's really going on within the FDA, and it's certainly not good. It's disappointing to learn that the accuracy of the PAP smear also appears to have become diluted, courtesy of the FDA approving new products that perform worse than the less expensive original. As stated by Krause:
"While outright misses by the device seem more frequent than by a cytotech, they are not high in number. When they do occur, the missed cellularity is often clearly visible; near misses are common. This should make lab supervision nervous, most seem unconcerned. Often, misses are never discovered. I asked my senior lab manager: How would you justify to the women in our community that this device is beneficial and worth the extra money charged? She looked stunned, totally silent, no response."
Indeed, I think most people would struggle to justify a situation such as this. Maybe it's time to stop looking for justifications, and start demanding some accountability?