Dr. Linda Posch MS SLP ND
Source: http://www.healthtruthrevealed.com
November 19, 2008

BIG PHARMA ON TRAIL… AGAIN

Merck Ignores Health Risk for Osteonecrosis of the Jaw

No matter how often a television commercial lists the numerous side effects of certain popular drugs, all the while enunciating a litany of horrors, it seems consumers absorb more of the smiling, pretty faces and contented families relieved of “suffering” than they do the drug company’s disclosures. Despite such poignant and legal disclosures, it appears that Americans can’t get enough pills for ‘what ails them.” After all, that is what such advertising is designed to do. This includes Fosamax, a drug sold by Merck. This drug is a chemical and belongs to the family of bisphosphonates, which are actually used as water softening agents in irrigation systems.

Although bisphosphonates have been traditionally related to jaw problems occurring in those who have been treated for cancer, they enjoy a wide and varied consumer base across the board, ranking 10th for sales of U.S. pharmaceuticals. This data is according to IMS Health, a company that tabulates health care and pharmaceutical commerce activity. A 2007 journal report in Osteoporosis International stated that 55 million U.S. bisphosphonate prescriptions are over zealously prescribed each year in the United States. This the result of a well organized and calculated fear based advertising campaign.

On August 11, 2009, a Federal lawsuit will include three pretrial litigations as a result of class action lawsuits filed against the pharmaceutical company Merck. This in response to users of their osteoporosis drug, Fosamax, which has been found to be the culprit to osteonecrosis of the jaw. Otherwise known as incurable jawbone death. Approved in 1995 by the FDA, this popular drug, primarily prescribed to women, enjoyed a cool $3 billion dollars in annual sales for Merck up until this year when the FDA, following the contested expiration of Merck’s patent in 2008, allowed generic versions of the drug to enter into the market. Unfortunately, many of these women, are not educated by their health care providers as to the potential side effects of this dangerous drug, and thus become innocent victims.

Although the whole point of Fosamax was to strengthen bones, a multitude of users of Fosamax have contended that the drug actually causes osteonecrosis of the jaw, a condition in which the jaw bone simply deteriorates. The lawsuits not only purport that the link between osteonecrosis and Fosamax exist, but also that Merck was more than aware of this horrific and devastating health issue. Moreover, they refused to alert public and medical authorities to the dangerous side effects involved with its use.

In 2005, multiple patients at the Long Island Jewish Medical Center, who had experienced oral surgery, were not healing properly. An exploration of the patients’ history quickly revealed that all of them had been treated with bisphosphonates, drugs that help lower excessive calcium in the blood or retard the growth of bone tumors. Ninety percent of these patients had some type of cancer and had been treated with Zometa or Aredia, also bisphosphonates. Of these, 10% had Osteoporosis and had been treated with a drug called Fosamax, an oral bisphosphonate.

This anomaly led to a warning from the FDA about the possibility of osteonecrosis being linked to oral bisphosphonates, jaw bone death. Bisphosphonates, whether IV or oral, disrupt the calcium balance in the cells that put calcium into tissue and also the cells that remove calcium. The final result, surprisingly, was an actual decision that all biophosphonates products should have a warning label regarding osteonecrosis.

Osteonecrosis of the jaw, whose acronym is ONJ, literally means bone (osteo) death (necrosis) of the jaw. It is a severe condition that occurs as the result of reduced local blood supply to the face and markedly affects both the upper and lower portions of the jaw. ONJ is a sub-category of conditions categorized as avascular osteonecrosis, which means, ‘dead bone from poor blood flow.’ Although ONJ has been recorded for more than a century and half, there has been a profound escalation of the condition within the last decade, a condition which has been attributed to the rampant and wide spread use of bisphosphonates.

The bisphosphonates target resorption, the process whereby old bone tissue cells are located and removed, in hopes that a slowed rate of resorption will be less vigorous than bone tissue formation. Some of the brand names under which bisphosphonates are sold are: Actonel, Aredia, Boniva, Didronel, Fosamax, Reclast, Skelif and Zometa.

An officious presentation of Foxamax in Drugs.com, a site billed as “the most popular, comprehensive and up-to-date source of drug information online,” offers this information about Fosamax, “Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells) and a pre-existing dental problem.” This description does little to shed true light on the real risks behind this so called medication.

In a sense, osteonecrosis of the jaw occurs because the cells have been starved to death of nutrients. The natural bone marrow takes on a fibrous appearance or disappears completely in certain areas, leaving only a hollow, marrow less area. This condition is known medically as osteocavitation. The consequences are damaged teeth, gum infections, nerve and facial pain and an area that rapidly becomes a target for bacterial infections which are wholly untreatable in the majority of cases. The end result of this big pharma induced pathology is uncontrollable jaw bone death. Oral surgeons are at a loss as to how to treat this condition. The worst case scenario is complete removal of the jaw.

Alendronic acid, its International Non-Proprietary Name (INN), or alendronate sodium, which is the United States Adopted Name (USAN) is sold in the United States by Merck as Fosamax. Fosamax is sometimes marketed in conjunction with Vitamin D supplements. The reason for the vitamin association is quite clear. It is done so to make a truly toxic substance (i.e., a water softener) seem healthy.

Bone is dynamic tissue and is constantly being replaced by the body. Small portions of the skeleton start forming a few weeks after conception. By eight weeks, the pattern is complete and is comprised of connective tissue and cartilage. At this point, real ossification (bone hardening) or bone development begins, continuing until the adult stature is realized. After that, the dynamism continues but typically for the repair of fractures and the natural remodeling required by the body when bone tissue is placed under stress (i.e. dancing, running, body building, etc)

There are three major cell types involved in bone development, remodeling and growth. Osteoblasts form bones. They do this by laying down new bone tissue. Oseteocytes are mature bone cells which have been put into place by the Osteoblast. Osteoclasts break down and reabsorb old bone tissue. They do this so that the osteoblast can perform its function of laying down new bone tissue.

Fosomax and its sister drugs, the other bisphosphonates, simply kill the osteoclasts so that the rate of bone tissue replacement proliferates but the density created is from old bone. From old bone that, under proper conditions, the osteoclasts would normally remove. Would you reinforce your house with layers and layers of rotting siding? This, in effect, is exactly what happens to the skeleton of anyone taking any of the bisphosphonates. When the osteoclast is unable to remove old bone tissue, one simply has a skeleton that is reinforced by old bone. A year or so later typically results in a bone scan that reveals increased density. What the American Public does not understand is the increased bone density that is recorded is the result of old rotten bone that should have been removed long ago.

For bones to be healthy, a balanced process of giving and taking has to be maintained. The osteoclasts seek out old bone tissue and remove it, the resorption part of the process, thus leaving behind spaces that are rough and uneven. The osteoblasts fill in these gaps with new bone cells. The osteoblasts and osteoclasts are partners in this process of creating new, healthy bone tissue. One cannot do its work well without the other. Under normal conditions, our bodies create approximately 5 to 10% of new bone tissue annually.

Osteoporosis is a condition exemplified by decreased bone density and a loss of bone tissue, creating increased vulnerability to fractures of the bones in the spine, hip and wrist. Bones simply become brittle and porous. Known as the silent disease, osteoporosis knows no boundaries although it seemingly affects post menopausal women at a much higher rate than other populations. Although questionable medications are in widespread use to “treat” this condition, it would seem more logical to pursue a healthy lifestyle which includes exercise, phytonutrients rich foods, whole food supplements and even occasional juicing to take advantage of concentrated and natural liquid vitamins. Research worldwide reveals that a healthy lifestyle indeed is beneficial to bone health no matter what the age and definitely decreases the risk of osteoporosis. The alternative certainly is a dismal state of affairs at best.

With alarming frequency, pharmaceutical companies accelerate at the speed of light in their efforts to get new products to market. Thereby enhancing their bottom line. Yet again, all at the expense and suffrage of the individual. The bottom line is that Fosamax is destroying the lives of many its users in a most horrific way. The reports are many of the innocent consumers who have had to have partial or complete jawbone removal. It would only seem just to ask Merck executives to function without a portion of their own jawbone intact. Once again, it appears that Merck did evade its responsibility by not warning consumers and medical authorities about the severe and potential side effects of its newest pharmaceutical “darling.”

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