In this book, "All Medicines are Poison" Melvin H. Kirschner, MPH, MD, sets out to remove the fog of confusion that clouds the landscape patients are required to navigate in their search for health care today. This book describes the risks and benefits associated with the use of medicines, and explores the validity of other treatment modalities referred to as "Complimentary and Alternative Medicine (CAM). He discusses the numerous failings and backroom dealings in the pharmaceutical and insurance industries, and highlights possible solutions to many of these current concerns.
ALL MEDICINES ARE POISON!
Making Your Way through the Medical MinefieldBy MELVIN H. KIRSCHNERAuthorHouse
Copyright © 2009 Melvin H. Kirschner, MPH, MD.
All right reserved.ISBN: 978-1-4490-1165-9Contents
Be an Informed Health Care Consumer....................................................................11. All Medicines Are Poison............................................................................32. What You Need to Know about the FDA.................................................................93. How Drugs Are Classified............................................................................194. Understanding Off-label Prescribing.................................................................295. The Scientific Method: The Gold Standard of Medicine................................................396. Why You Should Read the Package Insert..............................................................477. How Medicines Work..................................................................................538. Expiration, Interaction, and Duration...............................................................619. Side Effects and Allergic Reactions: It's Sometimes Hard to Tell the Difference.....................7110. Medicines and Treatments Must Be Thoroughly Tested.................................................8311. The Role of Sanitation in Disease Prevention.......................................................8712. What Is Informed Consent?..........................................................................9313. Antibiotics, The Wonder Drugs I Wonder If I Need One?..............................................9914. Do Placebos Have A Place In Medicine?..............................................................10515. Dosage Counts: Start Low and Go Slow...............................................................11116. Immunizations......................................................................................115Ethical Issues in Medicine.............................................................................12117. Advertising: The High Cost of Promotion............................................................12318. Why Prescription Drugs Cost So Much?...............................................................13119. Treatment Options Change Frequently................................................................14120. Doing Nothing......................................................................................14721. Conflicts of Interests: How They Affect Your Health................................................153Alternative Medicine, Not always a Good Alternative....................................................15922. Evidence-Based Medicine and Treatment..............................................................16123. High Test? Irradiated? Use Less?...................................................................16524. Poison, Cut, and Burn..............................................................................16925. Natural and Harmless...............................................................................17326. Ginkgo Biloba and Other Nonprescription Cures......................................................18127. Death by Dietary Supplements.......................................................................19328. Homeopathic, Chiropractic, And Holistic Medicine...................................................20129. A Healthy Dose of Skepticism.......................................................................209Challenges in Today's Health Care System...............................................................21330. Chemicals Essential to Life and Laboratory Tests That Identify Them................................21531. The American Health Care System....................................................................22532. The Medicare Modernization Act.....................................................................23333. "First Do No Harm": The Hippocratic Oath...........................................................239Postscript.............................................................................................247
Chapter One
BE AN INFORMED HEALTH CARE CONSUMER ALL MEDICINES ARE POISON
When I was in the second year of medical school in the 1950s, we were taught about medicines and pharmacology. At the University of Southern California (USC), we were very fortunate to have a pharmacology professor of world stature, Dr. John L. Webb. During our first year, while we were learning our basic medical sciences, he was visiting Maoist Red China, studying traditional Chinese medicines. Able to speak fluent Chinese, he was one of the rare Americans invited to China during the Mao era. We met him for the first time as we assembled for our initial class in pharmacology.
The setting was somewhat strange. At that time, the new medical school campus was just starting construction across the street from Los Angeles County General Hospital. Most of our classes were held in the old chemistry building at the main USC campus, which was across town from the planned new medical school location. The old chemistry building was so overcrowded that the pharmacology class had to be held in the cavernous general assembly auditorium on campus. It was designed to accommodate at least a thousand students.
In those days, our medical school class of fifty-eight was mostly male. There were only three female students. Today, medical school classes at USC are split about fifty-fifty. We were seated in a dimly lit corner of the large auditorium. Professor Webb was on the stage, standing behind a brightly lit lectern. He presented a rather commanding figure as he looked down at us for the first time.
"Ladies and gentlemen," he said, "I am here to teach you how to poison people!"
A brief pause followed while we sat stunned by those words. We were expecting to learn how to cure people, not poison them.
Then he added, "Without killing them, of course."
Thus, the title of this book originates from Dr. Webb's introduction to pharmacology. There followed a discussion of why and how all medicines are poison in some situations. I have never forgotten that lesson in the more than fifty years since I heard that statement. Years of medical practice have validated repeatedly what Dr. Webb taught us about medicines. Throughout that semester, he taught us to appreciate the uses and benefits that medicines have, but also the burdens (adverse reactions) they could cause and their interactions with other substances.
Properly used medicines are of great benefit and save lives, but we must always be aware of the burdens. Furthermore anything we ingest can cause problems. With this benefits-versus-burdens relationship in mind, we make our health decisions. Physicians are expected to educate patients about these matters. In our society, doctors advise, and patients decide.
When I was a child, tincture of iodine came in a unique brown bottle with a skull and crossbones embossed on its side. The skull and crossbones implied danger, poison, and even death. In those days, tincture of iodine was widely used as an antiseptic for cuts and abrasions. It stung when it was applied, but not from the iodine. The sting was from the alcohol it contained. It was painted on cuts and lacerations to keep them from becoming infected. Iodine is still used, but in an aqueous solution that is still an excellent antiseptic. Without alcohol as the solvent, it doesn't burn when applied to a wound.
In the tincture of iodine days, we kids preferred Mercurochrome. It could be applied to a wound without causing the burning pain that iodine caused. It also prevented infection, and it wasn't marked as poison. In fact, Mercurochrome was a mercury compound, and it was a poison, but the bottle did not have a skull and crossbones embossed on it. The likelihood of actually becoming poisoned by the mercury in Mercurochrome was remote. One used a small amount on the wound, and it was never ingested.
Humans have used mercury in many forms. Thiomersal, an organic mercury compound, was used for many years as a preservative of drugs in sterile ampules (small glass bottles) that held several doses prior to injection. Some authorities suspected thiomersal in immunizing vaccines was causing autism in children. The Food and Drug Administration (FDA) has ordered that thiomersal be removed from injectable medications. Studies have shown that thiomersal does not cause autism, but this chemical substance has never found its way back into pediatric immunization vaccines. They now do not contain mercury.
Another mercury hazard exists in certain fish that feed in mercury-contaminated waters. The FDA and Environmental Protection Agency (EPA) have jointly issued a warning suggesting to the public (and especially pregnant women) to avoid eating certain fish that contain excessive amounts of mercury. The list includes shark, swordfish, tilefish, and king mackerel. These fish are known to concentrate the ingested mercury in their flesh. In theory, eating large quantities of these varieties of fish may present a hazard. It doesn't seem to bother the fish. By my calculation, one would need to eat an awfully lot of mercury-contaminated fish over a long period to reach a dangerous level of poisoning. Recently, pregnant women and children have been especially advised to limit their consumption of tuna. This information is detailed on the Internet at the FDA's Web site.
Another issue widely discussed in the dental literature, is the use of amalgams to fill cavities in teeth. Amalgams are compounded with mercury. Some dentists advocate removing all the amalgams and replacing them with mercury-free substances. This practice is based on the theory that the mercury in the amalgam is slowly absorbed from the tooth into the patient's body, thus causing a toxic reaction. Most dentists do not believe this because mercury poisoning has not been demonstrated in people who have had amalgams in their fillings for many years. The American Dental Association (ADA) and most dentists regard it as unnecessary to replace amalgams with fillings that do not contain mercury.
The National Council Against Health Fraud (NCAHF) published a position paper on the subject of amalgams on its Web site at www.ncahf.org. The dentists on the board of the NCAHF agree with the Council's position paper, which recommends against the removal of fillings containing mercury.
Iodine and mercury are two examples of natural substances that have been found beneficial in one setting but present risks and burdens that must be considered when they are used for other purposes.
WHAT YOU NEED TO KNOW ABOUT THE FDA
Prior to 1906, when the Pure Food and Drug Act came into existence, the use of medications by patients and doctors was essentially a buyer-beware market. Hucksters could sell anything and make any statement about the use and contents of their products, whether true or false.
Journalists of the time and books such as The Jungle by Upton Sinclair influenced Congress. The book vividly described the terrible sanitation and contamination of the food products the meatpacking industry of the time was producing. A complete copy of this text is still available on the Internet more than one hundred years since it was first published. In response to the poor sanitation and purity of the food being produced at the time, Congress created the FDA in 1906. This agency's mandate was to see that foods and drugs were not adulterated or misbranded.
In 1912, Congress added an amendment that specifically prohibited "false and fraudulent" curative or therapeutic claims on the label. In 1938, the Federal Food, Drug, and Cosmetic Act was passed. For the first time, the FDA required that, before marketing a new drug, a manufacturer had to submit evidence that the drug was safe and effective.
ANOTHER STEP TOWARD PATIENT SAFETY
The Kefauver-Harris Amendment of 1962 represented another major step forward for patient safety. Among other requirements, the Kefauver-Harris Amendment mandated the inclusion of complete professional information in virtually all prescription drug packages and sales literature distributed to physicians.
At that time, I had been in practice for only two years. As a new doctor, I found the description of hazards, side effects, and precautions to be very helpful in prescribing safely and appropriately. Detailed descriptions now accompany all prescription medicines. They are known as "package inserts," and they are extremely complex and somewhat confusing. Doctors have been accused of not reading them carefully enough before prescribing a new medication, so the FDA is currently in the process of revising the format so important prescribing information, such as adverse reactions and interactions, are displayed more prominently and made easier for physicians to review.
I read and reread this information and carry a pocket prescription drug reference (pocket PDR) with me at all times, yet the prescriptions I write still sometimes cause unanticipated adverse reactions. The number of humans studied during the required pre-release research period is relatively small. When millions of people start to use a new medicine after it is released for general use, unexpected side effects, interactions, and hazards surface.
For this reason, in the 1970s, the Drug Quality Reporting System (DQRS) was established, and pharmacists and physicians began reporting adverse reactions. The information garnered from these reports makes it possible for the FDA to monitor and even recall products that prove to be unsafe after their release.
THE STANDARD DRUG APPROVAL PROCESS
Drug companies spend millions of dollars researching new products. The company that is first to market a new class of medication is likely to make more profits than later competitors are. The drug approval process was tediously slow. This was necessitated by the methods required by the FDA to assure new drugs reach the market only after careful and thorough evaluation.
The FDA's Center for Drug Evaluation and Research (CDER) requires a standard protocol for studying potentially new drugs. Each proposed new substance is first subjected to animal studies in at least two species. This pharmacology/toxicology testing is to develop adequate data to undergird a decision that it is reasonably safe to proceed with human trials.
The first human clinical studies (Phase I) may be conducted in patients, and they are usually done in human volunteers. These studies, usually conducted on twenty to eighty subjects, are designed to evaluate drug metabolism and mechanism of action in humans. Side effects of increasing doses are also evaluated at this phase.
Phase II includes controlled clinical studies that are conducted to obtain preliminary data on the effectiveness of the drug for a particular indication in patients with the disease or condition. This phase of testing also helps determine the common short-term effects and risks associated with the drug. Phase II studies usually involve several hundred people.
If the Phase II studies do not eliminate a new drug, it then goes on to Phase III. These clinical studies are intended to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase III studies also provide information for inclusion in the product brochure being prepared for doctors who will be prescribing the new drug. This phase usually includes several hundred to several thousand people.
The real test of a drug is when it is approved for marketing and millions of patients use it. The FDA is aware that no amount of careful preapproval testing will reveal all of the risks and adverse reactions. So physicians are encouraged to report adverse reactions and effects not already described in the product brochure that accompanies prescription drugs.
When such reports are made, the FDA evaluates their frequency and significance. Reports of a serious nature have resulted in the addition of a black box warning to the product brochures and, at times, recall of the drug from the market. Side effects appear in the adverse reactions section of the brochure.
Enlisting adequate numbers of qualified volunteers for clinical trials has been a problem. In the past, clinical trials have primarily been done at the university clinics, but, in recent years, community-based physicians have done much research. Unfortunately, unscrupulous individuals have sometimes failed to follow the rigid requirements of valid research. Some well-meaning physicians who have been asked to participate in clinical trials or refer their patients do not understand the ethics involved.
The Los Angeles County Medical Association/Bar Association Joint Committee on Biomedical Ethics developed "Guidelines for Physicians Participating in Clinical Trials." With these guidelines, the committee hopes to provide a set of ethical standards that can be followed so physicians understand their ethical role and the patient is neither harmed nor misinformed.
These guidelines made it very clear that issues of informed consent, privacy, institutional review committee oversight, and other safeguards are in place before any human experimentation can be done in this society. This is a very touchy subject, which involves medical ethics, as all of the Committee's guidelines do.
An e-mail newsletter addressed primarily to physicians, "ePocrates Clinical Trials Connection," discussed the issue of clinical trials, stating that 80 percent of all trials are delayed due to poor recruitment. According to ePocrates News, in 2001, there were twelve hundred drugs in Phase III clinical trials. Only twenty-four new drugs and twenty-seven new drug formulations or combinations were approved that year.
CDER monitors study design and conduct of clinical trials to ensure people in the trials are not exposed to unnecessary risks.
I will later discuss informed consent, a critical component of all treatment and medical care in the United States. Obtaining the patient's informed consent is also required for clinical trial research. This requirement originates from the patient's legal and ethical right to direct what happens to his or her body. The language used to obtain consent must be in clearly understandable lay terminology.
THE PRACTICE OF FAST TRACKING
Another factor has entered the equation in recent years. The public has been demanding that drugs that show promise of helping critically and seriously ill patients be released before the required comprehensive studies are completed. This is commonly known as "fast tracking."
I agree with this practice, as the patients on whose behalf this is done are dying or suffering terribly and grasping at straws. But I do object to fast tracking drugs that are rushed to market before the benefits and side effects are well studied and understood solely because early release promotes profits.
Please don't read me wrong. Patients have greatly benefited from the many wonderful new medications that this industry has produced. But, as a physician, I must think of patient welfare first. I do not believe it is necessary to hasten a new drug to market when the condition it is intended to treat isn't life threatening or other effective medicines already exist.
Obviously, diseases such as AIDS, metastatic cancer, and other illnesses that lead to a painful and miserable death prompted the development of fast track standards. The language in the fast track rules that permitted other medications intended to treat nonfatal conditions to attain fact track status is in this statement that I quote from the FDA's fact track requirements:
The fast track programs of the FDA are designed to facilitate the development and expedite review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
(Continues...)
Excerpted from ALL MEDICINES ARE POISON!by MELVIN H. KIRSCHNER Copyright © 2009 by Melvin H. Kirschner, MPH, MD.. Excerpted by permission.
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