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Anyone Can Imagine

Anyone Can Imagine

Several years ago, I decided to take a trip to Germany to work with a small group of physicians from around the world. It was an exciting adventure to meet doctors from the Canary Islands, South Korea, Canada, Mexico and Germany. The company that sponsored the meeting was Eidam, Inc. Eidam manufactures the contact thermography unit we use at the Stone Institute. Contact thermography captures the body's stress response to the exposure of cold.

Over the past few years, what has become very clear is that there are several directions healthcare companies are taking to either enhance personal health or treat illness. The traditional pharmaceutical companies are still embracing the use of chemicals (drugs) to either bind to receptors to either turn them on or off, inhibit or enhance enzyme activities, act as bacteriostatic agents against infections, treat pain, provide chemotherapy for cancer and blood dyscrasias, or replace hormones in some form or fashion. When I went to medical school in the later seventies, the major emphasis of allopathic medicine was on drugs as the preferred treatment of illness. At the same time, medical authorities stressed that all drugs had side effects. Furthermore prescribing drug treatment required an assessment in real time of both the benefits and risks associated with the medication.

Over the years, there has been a huge public debate about the indiscriminant use of antibiotics for colds, flu and various illnesses and the resultant emergence of drug resistant bacteria. We have a few patients who are chronically infected with what the media labels superbugs. I spoke to a patient the other day who was ill with fever and cough. She did not want to take an antibiotic since she felt she probably had a virus. As we spoke about her issue with antibiotics, I asked her if she was wrong about her impression and she had an early pneumonia from a bacteria, was she willing to take the chance that a bacterial infection could kill her without treatment with antibiotics.

She looked at me and thought for awhile. Then she asked if there was an immediate test that could confirm or refute the nature of the illness: bacterial verses viral. I said no. I then asked her that if I did not prescribe her antibiotics and she died, would her family hold me accountable for her death, even though I was acting out of public health concerns, trying not to over prescribe antibiotics. She said, "I don't know." I followed up that question by asking her if she thought that at least one physician in the Memphis area would come to court to defend my actions for the sake of the public good, not prescribing antibiotics which would have cured her pneumonia. She said, "I don't know."

I prescribed her two different but synergistic antibiotics and sent her on her way. She was better in forty-eight hours. Bottom line: the mere idea of not prescribing antibiotics for patients who are ill is complicated and filled with a huge number of what ifs and therapeutic paths populated with many trap doors. In my opinion, this is a simple dilemma common in today's practice of medicine.

What's more difficult to assess is the emergence of the use of biologically active proteins for treatment of disease verses prescribing age-old drugs. Biologically active proteins are being used in the treatment of rheumatologic diseases, cancer, cardiovascular illness, and neurologic diseases. Humira® was one of the first drugs in this medical genre. It has been used for ten years or more in the treatment of different autoimmune diseases, and the manufacturer continues to get Humira® approved for different autoimmune mediated diseases which extends its patent life.

There is no question that this humanized IgG monoclonal antibody (protein) is effective in treating some patients with lupus, rheumatoid arthritis, psoriasis and other autoimmune diseases. However, the human immune system reacts to foreign monoclonal antibodies by making its own antibody to this biologically active medicine. Bottom line: patients with autoimmune diseases treated with these proteins will make antibodies to the treatment. We do not make antibodies to medications (since they are chemicals). What does that mean? There is usually an onset of another treatment induced immune mediated disease that is untreatable. The human biologic treatment can initiate a disease that can have much more devastating consequences than the initial rheumatologic disease that was being treated. There are a few laboratories that offer antibody testing to some of the newly introduced monoclonal therapies, but most medical insurance companies refuse to pay for the testing. That makes monitoring the use of biologics impractical since the fee for analysis is roughly $ 1,700.00 or more.

I have one patient who was treated with Humira® and developed inclusion body myositis and myasthenia gravis. He is now bed ridden and has to use a motorized wheel chair to get around. He is totally and permanently disabled from the treatment of his rheumatoid arthritis. His rheumatologist continued to increase the dose of Humira® even though he complained that he was feeling worse on the medication. It ended in a disaster.

Another disturbing fact is that the side effects of these biologics may not emerge for years. That is great news for the manufacturers since they can make a number of arguments to the FDA and courtrooms about the immune mediated side effects of their biologically active medications. The first argument will be that there is a lack of evidence connecting their biologic to another illness because there is such a great lag time. Traditional medication side effects tend to occur fairly quickly in the course of therapy. Why is this so important? Because the use of these biologics is expanding rapidly into areas of cancer treatment, a disease that many physicians believe is fatal: so desperate times calls for desperate measures. If there is initial benefit from the use of these biologics, there may be irreversible side effects after the therapy is discontinued. Ultimately the patient might be left with cancer reoccurrence and a newly developed autoimmune disease. The snowball effect could be massive. A cure for cancer is considered to mean that the patient survives five years; but what happens if the side effects of the biologic treatment do not begin to show for more than five years after the treatment was discontinued. What could be worse is that at the same time the side effects manifest, the cancer might return in a greater body burden than when it was first discovered. Now the dilemma intensifies. Do we treat with antiquated chemotherapy or try a different biological therapy?

I have evaluated a couple of patients who are experiencing serious autoimmune side effects from their biological cancer treatment, only to find out that their oncologists who have discontinued their experimental treatment are denying that the patient's newly emerged autoimmune disease is related to the discontinued treatment. A larger iteration of the same old story; there is no evidence that our prescribed therapy caused a treatment related disease.

One day soon, oncologists will have differing opinions about the use of biologically active medicines verses chemotherapy just the way they currently opine about the use of surgery, radiation and chemotherapy. I predict that in the near future, chemotherapy will become obsolete and patients will only be offered a biologically active protein therapy of some kind or another. This scenario will follow in many medical specialty areas. With the recent tort reforms in the judicial system and the inability of the current laws to protect patients from delayed side effects from biologically active medication, I suspect most hospitals and some physicians will have a windfall of profit with no real malpractice risk. The manufacturers of these new age medications will also enjoy handsome profits as many patients' lives become more broken and more desperate.

I also suspect there will be new technologies such as magnetic moment therapy that will soon emerge that might change the course of medicine all together. The fight to use these new technologies will be fierce since drugs and biologicals will be less effective and have more side effects. We will need a populace movement to overcome the massive drug company, drug store, insurance company and hospital profiteers, ultimately putting the best interest of each patient back in front of the physician prescribed treatment instead of solutions that generates huge money for everyone participating in the healthcare delivery system.

That day will come, but not without a high economic and emotional price. What do I mean by that? The economic issues are simple; less money for the fat cats on Wall Street, drug companies, pharmacies, hospitals and medical insurance companies. The emotional issues are complex; humans are feeling machines that think, not thinking machines that feel. When therapies are introduced that are relatively inexpensive and effective, people will begin to wonder what happened to all those loved ones who died after they underwent therapy that was unnecessary and expensive as well as ineffective.

I think you get the idea here: waste, pure waste. That is the emotional issue, a life might have been wasted for the economic profits of the system at large. Perhaps many lives, perhaps many more than anyone can imagine.

Imagine that tidal wave of emotion. Imagine.


Posted by Amanda Sanders at 10:59 AM
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