FDA Sleeps While Common Medications Poison the Elderly

On November 29, 2007 the FDA made a rather surprising, almost honest announcement. It said that it could not protect Americans from the dangers of drugs. A 56-page report by its Subcommittee on Science and Technology stated the FDA “suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.” This blistering report on the life-threatening shortcomings of the FDA was released with the stamp of approval of the head of the FDA, Commissioner Andrew von Eschenbach.

The flagrant disregard for human health by the FDA is not news to people who follow the subject closely. The FDA has been mostly dormant while 100,000 Americans die needlessly from drugs every year and another 3 million are injured so seriously they require hospitalization (half of those were already in the hospital!). The FDA management's neglect of duty and follow up on drugs already on the market is unconscionable and has been for a long time.

The reason the FDA report is only “almost honest” is because the report is little more than a fear-driven PR ploy by von Eschenbach to raise hundreds of millions of dollars from Congress with no strings attached; a lobbying campaign that is actively under way as you read this. Such money will not change the FDA because the FDA management is a corrupt revolving door with the industries it is supposed to be regulating. Rather, any new money will be used to further pie-in-the-sky research initiatives crafted by von Eschenbach to create profits for the cancer and sickness industry with new and very dangerous biotech drugs (he already undermined the scientific integrity of the National Cancer Institute using the same approach).

Drug Toxicity is a Public Health Crisis

The use of drugs as a primary tool of health care in our society is a hundred-billion-dollar-a-year scam, as well as a direct and dire danger to the health of anyone taking almost any medication for any period of time. On top of that, American citizens are being raped by excessive drug prices compared to any other country in the world. It is an acknowledged fact that the FDA has almost no clue of the actual risks of commonly used drugs on the market today and has totally failed the American public on post-market safety of drugs. Drug companies do everything in their power to suppress risk information and paint a false picture of benefits – even when they know their drugs needlessly kill or injure.

“Scientific articles” that show the “effectiveness” of drugs are little more than Big Pharma-written promo pieces that generate billions in sales. It is common practice for drug companies to illegally promote the off label use of drugs, even to our children. A legion of doctors on the take from and trained by Big Pharma is happy to comply. And the major media, paid in the billions for drug ads, carefully protects Big Pharma and perpetuates the false value of drugs. A majority of Congress is on the take from the Big Pharma lobby, and the White House is their best friend. Multi-national Big Pharma companies are playing Russian Roulette with the health of Americans and those responsible for protecting the public are complicit in the atrocity.

The toxicity of commonly used drugs is a serious issue. There are anti-energy drugs like statins to lower cholesterol that are slow and deleterious poisons, progressively and insidiously worsening health over time. This 20-billion-a-year statin industry maintains its charade through a carefully orchestrated public health image of false benefit. In the elderly population statins clearly increase the risk of death and giving them cannot be justified for the great majority that is currently having them crammed down their throats. I'll write more about this ongoing statin debacle in an upcoming article.

Then there are the drugs that are so dangerous they are oftentimes immediately toxic. A new study in the Annals of Internal Medicine shows that three common drugs are responsible for 1/3 of all emergency room adverse drug reaction visits by the elderly (age 65 and over). The drugs are Coumadin/warfarin (17.3%), insulin (13.0%), and digoxin (3.2%). Since warfarin is the worst offender I will use it as an example to illustrate my points – though it is just as easy to explain similar problems with insulin or digoxin.

Warfarin – A Practice-Building Drug Given to Promote Recurring Office Visits

It is not at all surprising that warfarin heads the list of drugs sending the elderly to the emergency room. This drug works by poisoning vitamin K receptors on platelets so that they cannot stick together – the hope is to prevent a stroke. It is commonly given to elderly individuals with atrial fibrillation and according to carefully crafted “studies” may reduce their risk of stroke a paltry few percentage points. It is a cash cow for the prescribing physician, as it keeps patients coming back to the office to have their clotting times tested to make sure their artificially-produced clotting time is in a range deemed desirable by the doctor. Most elderly individuals with atrial fibrillation are in poor health in general, making this a difficult patient population fraught with the risks inherent in multiple drug use.

Excessive bleeding is a primary side effect of warfarin. It is not surprising that you can buy warfarin in the rat poison department at Home Depot. A high dose is very effective at making animals bleed to death. There is a fine line between a Home Depot dose and what doctors prescribe. This means that if you are taking warfarin and rupture a blood vessel in your brain (say from high blood pressure) your body may not be able to clot to save your life – as was the case with former Israeli Prime Minister Ariel Sharon. Hemorrhage-related strokes have quadrupled in the past decade, consistent with the rise in expanded warfarin use. The warfarin/hemorrhage risk goes up 45 fold if the person is 80 or older. Also, if an elderly person on warfarin gets in a car accident and starts bleeding they may have great trouble stopping – especially if the bleeding is internal.

Most discussions of drug benefits revolve around statistically concocted benefits of the drug, often in hand-picked patient populations, as is the case with warfarin stroke benefit studies. The studies are funded by drug companies, and if they don't pan out or the statistics can't be manipulated in some way to look good then they are thrown in the trash and never published. The benefits of drugs are never explained in terms of how the drug changes the body into a healthier state and solves the source of a problem – because drugs seldom ever do this. Drugs are about symptom and number management, and trying to titrate the poisons so they are not too toxic for something else that isn't supposed to be damaged (a near impossible task).

Warfarin is not only poisoning vitamin K function on platelets, it is poisoning vitamin K function throughout the body. Doing so is very reckless and never considered by the myopic medical profession. Vitamin K is a potent antioxidant that is vital for health and participates in synergistic antioxidant activities throughout the body that are needed for more types of healthy function than any doctor could calculate. Vitamin K is required to attach calcium to bone structure to form new bone, something warfarin blocks. This means that warfarin use over time increases the risk for osteoporosis. It is now reported that use of warfarin for longer than 1 year increases the risk of bone fractures by 25% - a risk that is not explained to anyone taking warfarin.

Unfortunately, when warfarin displaces calcium and interferes with normal vitamin K function it has the undesirable side effect of causing calcium to accumulate in arteries – otherwise known as hardening of the arteries or arteriosclerosis. This will speed the process of poor cardiovascular health, the same topic the drug is being given to assist.

Thus, we have a medical profession that thinks if they see an unnaturally-produced clotting time on paper they have somehow reduced the risk of a clot-related stroke. Such a conclusion warrants an IQ score of 80 – and that's the good news.

At least 30,000 of their patients per year wind up in the emergency room with bleeding-related problems. Even worse, at least that number ends up with a warfarin-produced hemorrhage stroke. And for those that survive those odds, the risk of fracture and hardening of the arteries also elevates. While any of these issues would be very important to an elderly person, the risks are seldom clearly discussed. Instead, doctors insist their elderly patients stay on this medication and keep coming back for office visits to measure their clotting times, using “fear of stroke” to gain compliance. It is easy to conclude that the only discernible public health benefit is the money earned by the physician for repeat office visits.

What if Doctors Could Think?

If doctors had some actual training on how to make people healthy and could stretch their imaginations to ask the most basic of questions then maybe they would actually be able to help their patients. What if they asked: Why does this patient have atrial fibrillation? Or, why does this patient have sticky platelets? Or, how could I help the patient have a more desirable clotting time by helping restore healthy circulatory function? The answers to these questions would certainly not be a deficiency of warfarin, i.e., taking a sledgehammer to platelets.

Maybe doctors could get past Health 101 and realize the cell membranes of platelets and other cells in the circulation are inherently flexible and do not stick together inappropriately when they are properly nourished, and need to stick together in certain situations. Numerous dietary supplements that promote cell membrane health, reduce inflammation, and/or enhance toxin clearance could be of immense help in these situations.

All we need do is look at the elderly in Italy who followed the Mediterranean diet for the course of their lives. They live to an older age than Americans. They have a much higher quality of health in the last quarter of their life than Americans. They are poorer, have very little medical intervention and drug use, yet live longer. What they do have is a fresh and mostly organic food supply.

Cleaning up the diet and removing irritants by eating an organic diet would do wonders for removing irritants from the circulation that make platelets stick together. The poor quality of our food supply is another area of betrayal of the public trust by the FDA, which now allows Frankenfood genetic mutations of real food to be sold as “food.” Managing stress is also very important. There are many options. Doctors would actually have to spend time getting to know the patient.

Yes – it is far easier and more cost effective for physicians to measure clotting times and never talk to the patient for any length of time. So what if the patient dies – they are old and are going to die anyway (a prevalent attitude in elderly health care). There are plenty more guinea pigs standing in line. Our medical care system is sick, especially in the fear mongering and negligent treatment of our elderly citizens. MDiety syndrome is a disease worse than cancer. These physicians don't have 1/100th of the wisdom of the people they are treating. There is no respect and dignity in our health system.

What is the FDA Doing about This?

Essentially – nothing. And now they have admitted they are a failure and are not able to protect the public from drug dangers. The FDA knows about the problems warfarin is causing. Is the FDA making sure there are proper warnings on the drug to make sure patients are informed of all the known risks? – no. Is the FDA demanding further post-marketing studies relating to the explosion of hemorrhage stroke consistent with the increase in warfarin use, especially in the elderly population? – no.

Instead, the FDA sees the warfarin problem as a business opportunity for the new drug and biotech industry branch of its operation known as the Reagan-Udall Foundation for the FDA – otherwise known as FDA, Inc. The only label change to warfarin that the FDA has proposed will require a $300 - $500 test of genes, profits that go into the pockets of von Eschenbach-friendly companies and forward the idea that genetic testing is essential for health (a fallacy). Never before has there been a more massive conflict of interest. The FDA will now market and license the drugs it is supposed to be regulating for safety, as well as put out testing requirements to prop up the new industry it is in charge of.

As payback to Orin Hatch (R-UT) for helping to turn the FDA into a quasi-drug company this past year (the most sweeping FDA change in 50 years) and being a huge backer of the permanent appointment of Andrew von Eschenbach to head the FDA, the University of Utah was awarded an FDA no-bid contract to do biomarker research using advanced genomics to determine which patients are most at risk for bleeding from warfarin.

This is what I mean by a pie-in-the-sky Andrew von Eschenbach project. It exists not to really help anyone, but to forward his personal agenda of evolving new tools that can be used in the cancer industry – lining the pockets of his many friends in the biotech industry. Raising more money for this agenda is the only reason von Eschenbach is sending out a panic message about the FDA's inability to protect the public. Fear is a great motivator.

The warfarin project is simply a test project to expand an entirely new field of science that will be used in the cancer-for-profit industry. In ten years it might produce a set of very expensive tools to use in a doctor's office for gauging warfarin toxicity differences amongst various patients – maybe. It is highly questionable that such research will yield better genetic tests than those that are already available and not widely used (due to cost and lack of proof). Sure it is important to forward scientific research. However, what about all the people dying from hemorrhage stroke and going to the emergency room because physicians are massively over-prescribing a dangerous drug that is basically only really good at producing repeat office visits and profits for Big Pharma?

The von Eschenbach warfarin project is a stupid waste of millions of taxpayer dollars – money the inept FDA is apparently already short on. Warfarin is toxic – period. It is a poison – period. It may be appropriate for some, but it is clearly over-prescribed in a patient population of poorly managed health. There are much better ways to naturally help people that the FDA is actively suppressing. This is all about profits for doctors, biotech companies, gene-experimenting food companies, drug companies, and preserving the vested interests behind a poor quality food supply AT THE EXPENSE OF HUMAN HEALTH. Beware of those using fear mongering to market their wares, whether it is happening in a doctor's office visit or coming from the head of the FDA. FDA management is corrupt and negligent of their responsibilities – a price that is being paid for in lost and damaged health by the citizens of this country.