THE COLUMBUS DISPATCH
Experts urge new controls in evaluating medical devices
WASHINGTON — Katherine Ayers was 36 years old when she decided that the pain in her hip had become too much to bear. A surgically implanted metal-on-metal hip joint soon made her pain-free.
But a few years later, she was startled to receive a letter saying that the artificial joint was being recalled. “In my mind, recalls were for dishwasher and cars, not body parts,” she told a congressional hearing earlier this year.
Ayers is one of 96,000 patients who received the implant before it was recalled.
It was experiences such as Ayers’ — and that of scores of others with even more serious consequences — that led the Institute of Medicine, an arm of the National Academy of Sciences, to call on the government to design a whole new system for evaluating and approving medical devices such as hip joints before they reach the market.
Medical devices range from simple adhesive-strip bandages used for minor cuts to contact lenses and pacemakers. When complex devices fail, they can generate health problems and health-care costs, even imperil lives.
- Surprising as it might seem, the way the present system works is that thousands of devices are routinely cleared for market without any of the clinical testing for safety or effectiveness that is required for prescription drugs.
“I thought that any medical device that was actually being put into people’s bodies had been extensively tested before it was released to the public,” Ayers said.
When the FDA was given responsibility for medical devices in 1976, Congress specified that those already on the market could continue to be sold without testing.
- At the same time, Congress created the so-called 510(k) process under which new devices could be cleared for market if they were “substantially equivalent” to existing products.
More than 90,000 artificial hips were recalled last summer after studies showed that about 1 in 8 recipients needed to have them replaced. The hips, manufactured by a subsidiary of Johnson & Johnson, were found to release small metallic particles into patients’ bloodstreams over time.
In 2009, the Institute of Medicine noted, about 4,000 medical devices were cleared under the expedited 510(k) process — more than 90 percent of all devices subject to FDA clearance.
Critics say the 510(k) process amounts to a loophole for marketing products without adequate attention to safety or effectiveness.
The FDA initiated two internal reviews of the process in 2009. This year, it outlined 25 changes it planned to make, including streamlining the review of lower-risk devices.
How much more proof do we need to fully realize that the FDA is such a major screw-up and is too inept to be able do the job it was assigned to do. This “department of government” has never protected us in assuring that we are safe from deceitful practices and fraud. How can it, when all it does is “front” for the big corporations and pharmaceuticals. One does not even need an elementary school education to fully realize that this practice is so terribly wrong that it should be labeled criminal.
Further proof that their ineptitude and loyalties lie exclusively with big money and power brokers is clearly demonstrated in their intrusion into our reliable, natural supplement industry where we are able to help ourselves to fill in the gaps against the deliberate debilitation and starvation of our population through genetically modified foods including most all growing flora and/or any animal flesh we might want to ingest.
Chemicals are killing us every which way from the middle. There is no way I can effectively state the true depth of my frustration over our contaminated food supply system in this country. We are all being poisoned to death in a drip, drip, drip fashion which causes us so many problems, in turn forcing us to see a doctor, who then begins a further introduction into our bodies with “pharmaceuticals” – – the most glorified of all chemicals since it is therein from which the “Power” emanates. This simply is NOT what medicine is supposed to be about! Big PhRMA diddles around with symptoms (seemingly unwilling to acknowledge cause area) – – their lab-made chemical formulae are not recognized by the body as food, therefore, are toxic to our body and cannot possibly “heal” anything. It is good wholesome, organic “FOOD” which gives the body what it needs in order for it to function properly and ultimately, be able to heal itself and then maintain homeostasis.
Some of the more noteworthy modern (20th and 21st century) physicians who really ARE able to help those of us who become too sick to function do not turn to chemicals to heal our broken bodies. Without exception, they set about to test and determine what the organic problems are and once integrated into an understanding of our total natures have at their disposal an understanding of the herbs and treasures of the planet which gladly yield their (magic) properties in measured quantities and successful protocols able to cope with almost any and all afflictions imaginable. Of course nothing is ever 100%. And everything or everyone who is born – – also dies. So what I am speaking of is NOT how to cheat death, but how to live more abundantly and joyfully – – the way our ancestors of just 100 years ago were free to do.
I have posted frequently on various physicians that I have learned about and there have been quite a few. My own experience with natural methods of healing truly blossomed when I bought Dr Clark’s books. But there have been a lot of good minds who have “practiced outside-the-box” . . Kelly, Gerson, Gonzalez. . other ideas from Somer’s book Knockout. Even someone like Dr McDougall who is not particularly “newager” or alternative, but he councils people in wholesome foods and getting off meds. And he is successful – his patients thrive, loose weight, wean off meds, gain energy and pride – that ain’t bad!
Probably Loren Cordain understands that he has a remarkable following. All from one simple book “Paleo Diet”. Amazing. People revere his every utterance, and he doesn’t even treat patients. But he has single-handedly changed the way people think about acne, food, exercise, dairy, and many of the “carbs” that most of us grew up on and dearly love. His logic and “science” is so acceptable and impressive. If he ever decided to hang a shingle out and give up his laboratory – – he would find SRO – a really big practice. Yes, it is still, Paleo Rules!
I beg everyone’s indulgence for today’s tirade – – I’ve been practically outside my body with bristling angst over this debacle called the budget deficit! Moments ago, I’m realizing that the leaders of both houses have come to an agreement (tho it has not been voted on until the morrow) to save all our butts. So I’ll be able to pay rent, bills and yes – EAT comes the 3rd. I simply cannot believe that there is ANY good reason to put millions of us thru this. Our troops overseas have experienced the same worries. I would like to tell you what I truly think of all this Tea-Party stuff, but I seriously MUST come down from this negativity. Really need to tap – big time.
If death is what we were after, it would be far simpler, less painful and much quicker to just do the Japanese chemical-suicide-routine which so many have spoken about recently. One whiff and its over! Easy. . .painless. . and cheap. Hey – – to his own! Lets face it – octogenarians can’t get jobs, and I’m quite sure I couldn’t pick up anything other than a cold on some street corner. So if one’s way of life were suddenly ‘cut off’ – what’s left? Too many people in Washington don’t give a thought to things like this. This is another of my passions and I will no doubt come back to this in due time – count on it. Meanwhile, don’t worry about me – – I’m one o those weirdos who love life and regard it a blessing, ( but it is really nice to believe that there ARE choices). Jan