Chapter 25
Drugs and Treatments
A wonder drug is a medicine that makes you wonder if you can afford it.
—Sheila Z.
Being diagnosed with a life-challenging condition heightens the awareness of how everything we do affects our health and well-being. This chapter considers drugs and treatments in that context.
Section 1. Your Rights
It is your basic, constitutional right to determine your own treatment. You have the right
• to receive complete information about your health and what the future might bring.
• to be informed about the benefits and risks of any recommended drugs or treatments and available alternatives so you can make an informed decision.
• to make and change decisions about your health, including any proposed treatments.
• to refuse treatment.
There is even a federal law, the Patient Self-Determination Act, that requires all medical care facilities receiving Medicare and Medicaid payments (including hospitals, skilled nursing facilities, home health agencies, hospice organizations, and health maintenance organizations) to inform patients of their rights and their choices about the type and extent of medical care.
It is also your right to share or withhold information about your health from family members, friends, your employer, coworkers, and anyone else. I am not suggesting that you exercise that right, merely that you be aware of it.
Section 2. When Your Decision Is Required ↑↑↑
Consider the following when evaluating a treatment or drug. These tips are based in part on the advice of Charles Inlander, president of the People’s Medical Society. Rather than trying to remember them all, feel free to photocopy these pages and take them to appointments.
Make sure your caregiver knows:
• What is most important to you about your medicines or treatment. Are you more concerned with
• the effect on your work?
• on your daily life?
• the fewest side effects or perhaps to avoid a particular side effect?
• taking the fewest number of pills or the shortest length of the treatment?
• cost factors?
• About any allergies.
• About unwanted side effects you’ve previously experienced from a drug or treatment.
• If you are or might become pregnant, or if you are nursing a baby.
• About any medicines you are taking, particularly those prescribed by another doctor or over-the-counter medicines you have started since your last visit.
• About any alternative treatments you may be using.
Make sure you know:
• The exact diagnosis and the cause of the problem you are experiencing.
• What the doctor is proposing, in terms that you understand.
• If any written information and published studies are available.
• Why you need the drug or treatment, the expected benefits, and their duration.
• What risks or side effects are involved. If there are possible side effects, what should you look for and what should you do if they occur?
• How the drug or treatment will interact with your other drugs or treatments.
• About your alternatives, including
• the benefits and risks of those alternatives.
• why the proposal under consideration is preferred.
• How much it will cost. If it is a treatment, does that include follow-up visits?
• If your insurance covers it. Will the doctor’s office find out for you?
• How to monitor progress and to read or interpret tests.
• The extent of your doctor’s experience with the drug or treatment. If you’re dealing with a specialist and not comfortable asking this question, ask your primary care physician to find out for you.
• If the doctor has a financial interest in your decision, one way or another.
If a lifestyle change is recommended, find out:
• How any suggested changes—such as in smoking, drinking alcohol, exercise, weight, diet, and the like—will improve your condition.
• How much change is needed to make a difference.
• The easiest way to implement the recommended changes.
Tip.
• Always ask a catchall question such as “Is there anything else you would ask if you were me, or that I should be aware of?”
• If there are several alternatives to choose from, ask your doctor, “If you had a child of your own in my situation, what would you suggest he or she do?” and of course, “Why?” Asking what the doctor would recommend to his child allows the doctor to express his opinions hypothetically, which may alleviate fears about liability that would normally prevent him from giving an opinion.
• Delete (and initial the deletion of) any provisions of a consent document with which you don’t agree. Always get a copy of any consent documents you sign.
Section 3. Where to Find Information About Drugs, Treatments, and Your Condition
If you want to know more about your condition, a treatment, and/or drugs, this section guides you to sources of information.
Your doctor. As may be expected, one of the best sources of information is your doctor. If you’re not sure about what you are being told, repeat it back to the doctor and ask if your understanding is correct. In addition to what he knows, he may have free literature for you in his office and should be able to direct you to additional resources.
Your pharmacist. Your pharmacist can answer any questions about drugs. He may even have literature about the drug.
Guardian Organization. Get all the information you can from your national and local Guardian-Orgs. Subscribe to newsletters that talk about the latest developments.
Support group. A support group is a good place to find information. A number of doctors have told me that people in a support group often know more about the course of a condition and the results of various treatments than they do.
Government. Several federal agencies offer free, comprehensive treatment guidelines about a variety of illnesses:
• National Health Information Center in Washington, D.C. (800-336-4797), refers callers to over a thousand organizations that provide medical information.
• National Institutes of Health (800-644-6627).
• Public Health Service’s Agency for Health Care Policy and Research (800-358-9295).
Libraries. Look for articles about your condition in medical journals and other publications. If your library doesn’t have the journals you need, locate a medical library open to the public by calling the National Network of Libraries of Medicine at 800-338-7657. In many libraries, the research librarians will do a computer search of medical databases for your condition or direct you to appropriate journals. In some libraries they will even print out the articles for a fee.
Tip. Medical journal articles may be difficult to wade through. If the words seem too technical, make photocopies and take the copies to your doctor for an explanation. Check out the reliability of the journal before relying on the findings described in the article.
Internet. The Internet is a new source of information. You can search medical literature or access journal articles and medical textbooks. If you don’t have your own access to the Internet, ask a friend who does. Many public libraries now provide Internet access.
Tip. Look in the resources section under “Treatment Information: The Internet” for a good place to start your search. Information is organized by category and is searchable by key words. The more specific you are, the more useless or irrelevant information you can filter out. Good general guides are HealthNet by Jeanne C. Ryer (John Wiley & Sons), $16.95, or Health Online by Tom Ferguson (Addison-Wesley), $17.
Tip. Check the date of the last revision each time you receive information from any particular site. If you really want to be sure to keep up-to-date, programs are available that will continually access the sites you choose and E-mail you updates.
Hired assistance. You can hire a medical researcher for a fee such as Planetree Library (415-923-3680), Health Resources (800-949-0090 or E-mail to moreinfo@thehealthresource.com), or Best Doctors (800-675-1199 or E-mail to www.bestdoctors.com). CanHelp (206-437-2291) is a resource service for people with cancer, directed by medical writer Patrick McGrady, that provides information on both conventional and alternative therapies.
Caution. Be skeptical of any information you receive anywhere, but particularly from the Internet. Track down the source and evaluate it for yourself, or have someone with medical knowledge of your condition help you assess it. Always consider the source, including any possible biases.
Tip. When you find information about research or treatment that seems pertinent, bring it to the attention of your doctor.
Section 4. Refusal of Treatment ↑↑↑
If you decide to exercise your right to refuse treatment altogether or to discontinue it, you can still receive pain medication and treatments to reduce the symptoms of your disease. (See chapter 30 for a discussion about hospice care.)
Your doctors will, almost certainly, offer information and advice about your decision to refuse a particular treatment or to stop treatment entirely. You may also want to consult your family and loved ones, and perhaps your religious group.
If the medical professionals or facility aides refuse to comply with your wishes
• be insistent, or be sure someone is insistent on your behalf.
• make notes, or have someone make notes, of the conversations you have about your wishes, including with whom you speak and what you both say.
• contact an attorney if all else fails.
Section 5. Prescription Drugs
5.1 If a New Drug Is Recommended
Review the considerations described in section 2 above.
On a separate piece of paper from the prescription, ask your doctor to write the exact name of the drug, the doses you are to take, and the number of times you should take it. Also ask what the drug looks like. You can then compare the information to the prescription bottle when you get it.
The National Council on Patient Information and Education recommends that you also learn
• the minimum and maximum effective dosages.
• the minimum and maximum cost for the drug and its generic counterparts. (A generic drug is an unbranded drug whose active ingredients duplicate those of a brand-name product.)
• how frequently the drug’s effectiveness must be monitored.
• what to do if you miss a dose.
• what food, drinks, other medicines, or activities you should or should not avoid.
• if and how often you can get a refill.
• how to store the drug.
• how to obtain any written information about the drug or its effects.
Tip. Keep a list of what medicines you take and modify the list as it changes. Keep a copy of the list in your wallet, particularly when you travel. If you have to tell anyone about the drugs you are taking, you can give them the list, or they will have it if you are unable to speak at the time.
5.2 Follow the Orders
While you are taking a drug
• take doses on time.
• don’t take drug holidays (a period during which you stop taking the drug without professional advice). If you misplace or lose your drugs, contact your physician immediately. Wherever you are, he can probably arrange an emergency supply of drugs for you.
• don’t take a larger or a smaller dosage than the doctor prescribes.
• never stop taking it without speaking with your physician first, no matter how good you feel!
• don’t borrow medication.
• keep it stored as directed. Don’t store drugs in the glove compartment of your car; the temperature varies too much.
• check expiration dates periodically and throw away expired medications.
• if you are on a complex drug regimen, ask for a written schedule showing the proper dosage and timing for each medication, as well as whether it should be taken with or without food, and any other instructions.
Tip. If you suffer an adverse reaction to a prescription drug, call your health care professional immediately, then report your experience to the FDA’s MedWatch program at 800-332-1088. The program monitors patients’ adverse reactions to drugs.
5.3 Monitor Your Progress on the Drug
• Pay close attention to any changes in your body, particularly when you start taking a new prescription or stop taking an old one. Seek help immediately to solve any problems that arise.
• Study and evaluate test results.
• Describe to your doctor any changes in your symptoms (good or bad) since commencing the prescribed medicine or any problems you may be having taking it.
• Inform your doctor if you are not following prescription specifications.
• Do a medicine checkup every six months to spot hidden problems. Schedule a time with your pharmacist or doctor to examine all of your medications (prescription, over-the-counter, herbs, etc.). They can check for duplicate, contradictory, or outdated medication and proper doses. This is a good time to ask your doctor if you can now discontinue using any drugs. An easy drug checkup method is to put all your drugs into a bag and take it to your doctor or pharmacist.
Tip. If your blood is tested regularly to monitor a particular medication, don’t switch between different versions of the drug without informing the person who administers the test.
5.4 Compliance Aids
If you are taking a batch of drugs and having trouble keeping track of them, compliance aids can help remind you to take your doses on time and keep track of the doses you have taken. Ask your pharmacist or doctor for what is available, or look in the catalogs listed in the resources section under “Daily Living.”
Tip. A multisection screw box, which you can find in your local hardware store, is an inexpensive compliance aid. Group your pills according to day, time, and dosage. This way you only have to sort your pills every few days. Also, you can easily monitor whether you have taken the pills or not.
If timing is important, there are pillboxes with timers built in that will fit in your pocket or purse. There are also watches with timers that you can reset as needed throughout the day.
Tip. If you’re having trouble taking a pill that sticks to your throat, try taking it with something that is carbonated. The carbonation seems to cushion the pill, making it easier to swallow. If the pill is the kind that starts to melt in your mouth and tastes awful, purchase empty gel capsules from your pharmacy and place the pill in the capsule before swallowing.
Section 6. Purchasing Drugs
6.1 Choosing a Pharmacist
Choose a pharmacist with the same care and consideration that you use in choosing a physician: he is another member of the medical part of your team, helping you achieve the best results from your medications. The pharmacist may know more about the benefits and risks of the drugs you are taking than your doctor does. To maximize the use of your pharmacist, think of him as an educator about drugs. The pharmacist can help select prescription and nonprescription medications effectively, inexpensively, and safely.
When considering a pharmacist
• look (or ask) for a certificate indicating that the pharmacist is licensed.
• look at the pharmacist’s education. Make sure your pharmacist has at least a bachelor of science degree and is not just a pharmacy technician. Few pharmacists with a doctor of pharmacy degree work in a pharmacy. According to the People’s Medical Society, the additional degree is not critical to good care.
• look at whether the pharmacist has a computer program that can create a printout about each drug, including its effects, side effects, and interactions.
• are you comfortable speaking with the person?
6.2 Choosing a Pharmacy
When evaluating available choices, consider
• if the pharmacy’s prices are competitive.
• convenience of location and/or delivery.
• emergency access—how do you obtain necessary drugs when the pharmacy is closed or the druggist is not there?
• if the pharmacy stocks the drugs you need. Does it have the refill policy you want? Can you get refills at other locations? Will the pharmacist call your doctor for you?
• if an area is set aside for you to speak privately with the pharmacist if you want to.
• if the pharmacy accepts your drug insurance plan or government drug assistance program.
• if you travel for work or recreation, can your pharmacy cooperate with out-of-state or foreign drug dispensers without hassles or extra fees?
• Does the pharmacy stock generic drugs? Once a patent expires, a drug often becomes available from more than one source and the price falls. Generic drugs are usually sold at substantially lower prices than their brand-name equivalent. If your doctor prescribes a brand name, ask your pharmacist if there is a generic equivalent that is less expensive. There is a small risk that variations in the fillers or other inactive ingredients in the generic drug may alter the way the active ingredients work in your body. Consult with your pharmacist about this. If a question remains, call your doctor.
Make sure to inform your pharmacist of any over-the-counter medications you may take from time to time, since interactions with your prescriptions are possible. For example, if you are on ibuprofen and your doctor prescribes steroids, the interaction could lead to ulcers. If the pharmacist has a decent computer program, it will alert you to inappropriate combinations.
Periodically compare the total cost for your drugs with other pharmacies to see if the price you are paying is still competitive. A few minutes of calling can save many Life Units.
Tip. If more than one doctor prescribes drugs for you, work with one pharmacy to fill prescriptions, even if the cost is a few dollars more for some items. With one pharmacist monitoring your complete medication record, it is more likely that allergic reactions and dangerous interactions can be prevented.
Tip. To save money, when filling a new prescription, consider asking for an initial one- or two-day supply to check for side effects. You’re only charged for the few pills instead of filling the entire prescription. If there is no adverse reaction, you can pick up the remainder of the prescription in a day or two.
Tip. If you belong to an MCO, are under the care of a hospital-based doctor, or are being treated at a hospital clinic, you may be able to purchase drugs from the MCO or the hospital pharmacy at a discount.
Tip. If the prescription is a refill and the drug looks different from the ones you took before, ask for an explanation. It may be another manufacturer’s version of the same drug, or it may be a mistake.
6.3 Mail Order Drugs
A growing alternative to purchasing drugs from a local pharmacy is ordering them through the mail. In addition to convenience, people are using these services when they want to assure confidentiality about their condition. Prescriptions by mail may be, but are not always, cheaper than a local pharmacy. Some of the mail order companies have the safeguard of computerized medication profiles that protect against drug abuse and potentially serious drug interaction. If you are considering using a mail order pharmacy, find out
• the prices of the various drugs you need.
• what to do until the medicine arrives in the mail.
• what to do if the medicine doesn’t arrive.
• what to do if your supplies run out.
• what happens if the pharmacy’s supply of the drug runs out.
• if the mail order pharmacy accepts your insurance.
• if confidentiality is an issue, what the packaging looks like in which drugs would be delivered.
• if a pharmacist or other expert is available to monitor the drugs you are taking, to check for improper combinations, and to answer your questions.
• if the pharmacy has computerized medication profiles to protect against potentially serious drug interactions.
You can locate a mail order pharmacy through your physician or your GuardianOrg. There are many reputable companies in the field. Large national companies include: AARP Pharmacy Service (800-456-2277), and you don’t have to be a member of American Association of Retired Persons to access the pharmacy; Community Prescription Service (800-842-0502); Stadtlanders Pharmacy (800-238-7828); and STAT Script Pharmacy (800-869-6593). The Veterans Administration has a mail order pharmacy for veterans. If your insurance coverage requires you to make a copayment or pay a percentage, ask whether the pharmacy will waive the requirement.
6.4 Buyers’ Clubs
Buyers’ clubs provide access to experimental drugs, foreign drugs, or alternative therapies. Some buyers’ clubs provide access to marijuana. Buyers’ clubs can also be an unbiased source of opinion about various drugs and treatments. Your doctor, support group, or GuardianOrg can point you in the right direction if such a club exists for your condition.
6.5 Drugs from Foreign Countries
Medicines in Mexico can be one-quarter of the cost of the same drugs in the United States. However, drugs made outside the United States are not subject to the Food and Drug Administration’s rigorous standards. Some drugs may be the same as those made here, but it is not a sure thing. If you do decide to purchase drugs from abroad, be careful about what you buy and from whom.
6.6 Insurance
Check your insurance coverage to determine whether prescription drugs are covered. If they are, there may be a deductible and/or a copayment. If drugs are not sufficiently covered, look for a health plan that is better for you. If you cannot realistically switch, this is a good time to start setting money aside to cover the cost of essential drugs.
6.7 Medicare/Medicaid
Medicare does not cover drugs, but supplemental “MediGap” policies are available to cover this expense. Medicare+Choice plans also cover drugs. Medicaid does cover prescription drugs.
6.8 If You Can’t Afford a Drug
• Talk with your doctor and social worker. They may have ideas for you.
• Explore patient-assistance programs run by drug companies by calling them directly. Call for a free copy of The Patients Assistance Directory, which lists asset requirements and free drugs available from various manufacturers (800-762-4636). The Pharmaceutical Manufacturers’ Association (202-835-3400) and the Senate Aging Committee (202-224-5364) have lists of free drug programs. For a list of free HIV drug programs, contact the Treatment Data Network (800-734-7104).
• Look for state or local programs that will pay or health clinics that will provide the drugs. Call your state health department or your local GuardianOrg. Veterans without negative discharges are eligible for drugs at a cost of $2 per prescription when prescribed by VA doctors.
6.9 Taxes
Prescription drugs are deductible as “medical expenses” for income tax purposes if the appropriate threshold amount is satisfied (see chapter 18).
6.10 Take Care
Drugs may have serious effects on your activities. If you fall asleep and cause an auto accident, the fact that the drugs were prescribed will not shield you from financial liability. Drugs and exercise can also be a hazardous combination. For example, aspirin and tranquilizers mask pain that should warn you when to stop. Elizabeth R. tore a ligament because she didn’t feel pain’s warning signals.
If you generally practice safe sex, be particularly careful when having sex while taking drugs that may loosen your inhibitions, such as painkillers or tranquilizers.
Consult with your doctor about the drugs you are taking, including over-the-counter drugs, and how they may impact your lifestyle.
Section 7. Over-the-Counter Drugs
There is a growing trend to convert drugs from prescription-only to over-the-counter sales. While direct access to these drugs may lower your costs and increase your ability to manage your health, it also increases the risk of misuse. Just because a drug is available without a prescription doesn’t mean it is harmless, or that it won’t adversely interact with other drugs you are taking.
Any self-prescribed drug inherently has risks to consider:
• You may have misdiagnosed yourself.
• Certain side effects may be dangerous for you.
• Adverse interactions with prescriptions or chemotherapy.
• Developing a harmful dependence.
Before taking any over-the-counter drugs, check with your health care provider, and do your own research as described earlier in this chapter as if the drug were a prescription drug. At the least, check with the pharmacist when you purchase any over-the-counter drug you haven’t used before.
Tip. Don’t rely solely on the labels or inserts that accompany over-the-counter drugs. They don’t tell you everything you need to know about using these drugs. You do not save money by purchasing unnecessary, ineffective, or possibly detrimental over-the-counter drugs.
Tip. It is often advisable to purchase single-ingredient over-the-counter drugs. Compare the cost of the single-ingredient drugs against the multi-ingredient drug.
Taxes. Over-the-counter drugs are not currently considered tax deductible.
Section 8. Experimental Drugs—Clinical Trials
8.1 In General
If you are not satisfied with the current drugs on the market, or they are not working for you, you may want to consider experimental drugs produced by reputable manufacturers conducting studies known as clinical trials. The National Cancer Institute defines a clinical trial as “an organized study conducted in people with [a health condition] to answer specific questions about a new treatment or a new way of using an old treatment.” Each study is designed to find new and better ways to help patients.
Anyone who wants to access unproven drugs should do so through controlled clinical trials overseen by the federal Food and Drug Administration. Before a new drug or treatment is tried with patients, it is carefully studied in the laboratory. Nevertheless, this research cannot predict exactly how a new treatment will work with patients.
Eligibility for studies in different phases depends on the type and stage of your condition, and what therapy, if any, you have already had.
Clinical trials are divided into three basic groups.
In Phase I, the earliest stage of a drug’s development, the safety and dosage level are tested in a small number of people. Phase I trials do not occur until enough laboratory evidence indicates that the drug will be safe for use by people. There may still be significant risk. Admission is generally offered only to patients whose condition cannot be helped by other known treatments. If the drug appears to be safe, it moves to Phase II.
Phase II is designed to find out if the treatment actually controls the condition in people. The trial monitors treatment response as well as side effects. If the drug is effective, it moves into a Phase III trial.
Phase III is conducted with a larger number of patients. It reveals the percentage of patients in which the drug is effective and further illuminates side effects. This phase compares the standard treatments with treatments that appeared to be effective in the Phase II studies.
If a clinical trial shows that one trial treatment is superior to another trial treatment, the trial is stopped and patients in each group are given the preferred treatment.
In a clinical trial, results observed in patients getting the treatment are compared with the results in similar patients receiving a different treatment or a placebo (inactive) treatment. Generally, if a patient in a trial does not receive the new treatment, he or she at least receives the standard treatment. No one is given a placebo without being informed prior to entering the study that it is a possibility.
Generally, neither the patient nor the researchers know who is receiving the therapy under study as opposed to the placebo. Since, by its nature, a clinical trial is a study of a new drug, it is not a proven therapy and it doesn’t necessarily work. Only a small fraction of new drugs tested are proven safe and effective. With any new treatment there may be risks, some unknown, and some that may be permanent and serious, even life-threatening. In each case, the unavoidable risks of your condition should be weighed against the potential risks and benefits of a new research treatment.
The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated or federally funded (at least in part), with built-in safeguards for patients. For example, federally funded and regulated clinical trials must first be approved by an institutional review board at the institution or group where the study is to take place. These boards protect patients. They review the study to see that it is well designed with safeguards for patients, and that the risks are reasonable in relation to the potential benefits.
Participants in a clinical trial must be volunteers. People may participate with the hope for a cure for their condition, a longer time to live, a way to feel better, or to contribute to a research effort that may help others. All patients in a clinical trial are carefully monitored during a trial and followed up afterward.
Each trial must be judged on its own merits. Some trials may not be in your best interest because they require that you stop taking other medications that are helping your condition. If there is more than one trial for a drug of interest to you, look at each one for protocol design, the ground rules for that trial. You may prefer the methodology of one over the other.
8.2 Costs
Usually, participating in a clinical trial costs nothing, although you may pay for blood or other ongoing tests. If there are costs, check your insurance policy to determine if it has a specific exclusion for “experimental treatment.” If it’s not clear, ask your insurer. Many companies handle new treatments case by case, rather than having a blanket policy.
If participation requires hospitalization that is not covered by the study, request hospital precertification from your insurance carrier as soon as possible. Ask the trial or hospital to set a target date for the procedure and give it to the insurer so the insurer has a deadline for making a decision.
Talk to your doctor about the paperwork to be submitted to your insurer. Often the way the doctor describes a treatment can help or hurt your chances of insurance coverage. Have your doctor and the hospital send an information package to the insurer that includes studies supporting the procedure’s safety, benefits, and acceptance by the medical community.
If you need financial aid to participate, contact your GuardianOrg. Also let the people conducting the trial know; they may know of funding sources for their trial or cover the expenses themselves.
8.3 Before Joining Clinical Trials
Read everything you can about the drug and the trial, and discuss the drug and protocol design with your physician, preferably your specialist. Also ask the sponsors of the trial
• whether you are eligible to join.
• the purpose of the study.
• what kind of tests and treatments the study involves and how they are done.
• what is likely to happen in your case with, or without, this new treatment.
• what are the other choices and their advantages and disadvantages.
• how the study could affect your daily life.
• what side effects you can expect from the study.
• how long the study will last.
• if you will have to be hospitalized. If so, how often and for how long? Is it clear that you will not be charged for the hospitalization?
• if you will have any costs.
• if you are harmed as a result of the research, what treatment would you be entitled to and in what setting.
• what type of long-term follow-up care is part of the study.
Tip. Before agreeing to participate in a clinical trial, consider that you may receive a placebo. If joining the trial requires discontinuing current medication, or not starting other proven medication, what could happen to your condition in the meantime?
8.4 Informed Consent
If you agree to take part in a clinical trial, you will be asked to sign an informed consent form. This form verifies that you have received all of the information necessary to make your decision, including the trial’s potential benefits and risks. Before you sign, understand what risks you face. Ask the doctor or nurse to explain any parts of the form or the trial that are not clear. Even if you sign the form, you are free to leave the trial at any time and can receive other available medical care.
If you join a trial, be aware that informed consent is ongoing. You should continue to receive any new information about the treatment that may affect your willingness to stay in the trial.
8.5 Locating Clinical Trials
Consult
• your doctor or a doctor who knows your case.
• your GuardianOrg.
• other people with your condition.
• publications aimed at people with your condition or that just list clinical trials relating to your condition (see the resources section).
• the drug companies directly. Their phone numbers are in the Physicians’ Desk Reference, available in most libraries.
• the Internet.
Cancer trials. Cancer patients can determine eligibility for a clinical trial by contacting the Cancer Information Service at 800-4-CANCER or www.icic.nci.nih.gov., a comprehensive information service sponsored by the National Cancer Institute that helps patients search for appropriate clinical trials. Currently, more than fifteen hundred clinical trials are in this database.
HIV/AIDS Trials. People with HIV/AIDS can call the AIDS Clinical Trial Information Service at 800-874-2572 or www.actis.org. The service has a video, HIV/AIDS Clinical Trials: Knowing Your Options, for $15. Another source of HIV/AIDS information is the CDC National AIDS Clearinghouse at 800-458-5231, which has several free brochures on clinical trials.
8.6 Obtaining a New Drug Other Than Through a Clinical Trial.
Drug companies sometimes make experimental drugs available to individuals outside of a clinical trial. One means of accessing these drugs is through compassionate use, an exception made for individuals case by case, when, for example, a person has no further treatment options. Another alternative is through expanded access programs, which give an experimental drug to individuals who fit a certain medical profile. As with clinical trials, there is usually no charge for drugs obtained in this manner.
Section 9. Alternative Medicine and Treatments
9.1 In General
Alternative medicine and treatments include any medical practice or intervention that lacks sufficient governmentally recognized proof of safety and/or effectiveness against a specific disease or condition. The administration of these drugs or treatments is not generally taught in U.S. medical schools and not generally covered by health insurance providers.
According to a study in the New England Journal of Medicine, in 1990 one in three patients used alternative therapies, many of which were developed in the East—such as acupuncture, stress reduction techniques, and yoga—and natural products such as green algae and special diets.
Alternative or complementary treatments can be an expensive drain on your budget and must be approached with caution since there are so many frauds who just want to make money from people in your situation.
If you want to use an alternative treatment, it is best to do so through a clinical trial. As discussed above, clinical trials are regulated by the FDA and provide safeguards for patients.
If a clinical trial is not available, before getting involved in any alternative therapy, the NIH Office of Alternative Medicine recommends the following:
• Obtain objective information about the therapy. Talk with people who have gone through the treatment recently, and those treated in the past. Ask about the risks, side effects, results, and over what time span results can be expected.
• Inquire about the training and expertise of the person administering the treatment.
• Consider the costs (in both Life Units and money).
• Discuss the idea with your primary care provider. The doctor will probably have information for you, even if he does not like the idea of alternative treatments. If nothing else, the doctor needs to know what you are doing to have a complete picture of your treatment plan.
In addition, when deciding whether to try an alternative medicine or treatment, tailor the questions in section 2 to the medicine or treatment under consideration. Your GuardianOrg may also have valuable information for you.
Caution. While most alternative medicines and treatments appear to be harmless
• be sure to watch for negative reactions.
• if you postpone proven medicines and/or treatments while you take the alternatives, be sure to understand whether there is any risk, and if so, what it might be. For example, while a cancer patient rejects proven therapies in favor of unproved ones, a condition can advance beyond the point where proven therapies can help.
Tip. If you have cancer, an admirable analysis of alternative treatments is contained in Choices in Healing by Michael Lerner (Cambridge: MIT Press, 1994).
Insurance. While most insurance and managed care contracts do not cover alternative treatments, as of this writing more companies are beginning to cover them. If you want to explore any drug or treatment, contact your insurance carrier or your managed care company to find out if they cover complementary or alternative treatments, and if so, which ones and to what extent.
9.2 Herbs
Centuries of anecdotal evidence and a number of recent formal studies indicate that certain herbs may be beneficial to health. On the other hand, the U.S. Food and Drug Administration has identified a number of herbs that can cause serious harm.
There are no standardized sources of information. If herbs are of interest to you, you will have to assess the available information as best you can.
Knowing what an herb is supposed to do is just the beginning. The odds are you will not have access to the herb in its natural state and will have to purchase it, generally in pill form. Herbs are classified as “dietary supplements” and as such are not regulated by the Food and Drug Administration. Because of the lack of regulation, there is no guarantee that herbal pills are what they say they are.
Products go to market with no testing for efficacy. There is no way of knowing if a plant’s active ingredients, whatever they are, have ended up in the herbal pills you purchase, what else is in the pills, whether they are safe, or whether the dosage is correct in general, much less correct for you. Since there are no quality controls or standard manufacturing requirements, you can’t even be sure that the pills are the same within a bottle, or from bottle to bottle.
Before taking herbs.
• Consider changes to your diet or lifestyle that might accomplish your goals without taking the herbs.
• Determine what the herb is supposed to do.
• Do your own research to determine minimum and maximum dosages and possible risks.
• Check with your doctor before taking any herbs. A supplement may interact negatively with a drug you take or pose a serious side effect. For example, when you receive chemotherapy and suppress your immune system, herbs can kill you because they may contain fungi and bacteria that are hard to isolate and treat. The doctor may know of a conventional treatment that you should try first.
• Do not rely on the printing on the package or in pamphlets. Supplements are prohibited from claiming to cure or prevent a disease, but the label is permitted to detail how a supplement affects the body’s “structure of function” as long as claims are “truthful and not misleading.” Label statements may not have a lot of evidence backing them up. FDA approval is not needed for package or marketing claims.
• A naturopathic physician (a physician who has studied natural remedies) can put you in touch with the herbs and other natural treatments that are the most reliable.
Consumer Reports did a study in this area and also recommends:
• Pregnant and nursing women should not take herbal supplements unless their doctor gives the green light.
• Check the warnings on packages and related material. Start with small doses.
• Buy herbs that at least claim to be “standardized.”
• Stick to single-herb products, not combinations whose actions are difficult to sort out.
• Be alert to the herb’s effects, both positive and negative.
• Stop immediately if there is a problem, and call your doctor.
Tip. More expensive is not necessarily better—and this applies particularly to herbs.
Section 10. Health Supplements
Many people fight wasting (rapid weight loss caused by their health condition) and other life-challenging conditions by using food supplements to build up lean-body mass. Before starting to take any of these supplements, or continuing them:
• Check with your doctor to see what he thinks of the supplement you are considering, and whether it impacts negatively on your situation or any drugs you may be taking.
• Supplements should not and cannot replace a balanced diet.
• Read labels to see if the items have been tested in a double-blind placebo control trial. If that information is not on the label, call the manufacturer and ask for detailed references and abstracts that back up the claims. Also look at the proportion of sugar to protein to ensure that the product is not all fizz and no substance.
Section 11. Treatments
11.1 Decisions
See the discussion in section 2 for considerations to think about before deciding to undergo any treatment.
11.2 Surgery ↑↑↑
Questions to ask before you agree to have surgery. To ensure that surgery is necessary and/or to maximize chances of success, ask the following questions of your physician or the proposed surgeon:
The operation
• Where will the operation be done? If in a hospital, what has their track record been with this type of operation? Can it be done on an outpatient basis? If so, what would be involved?
• What kind of anesthesia will be needed, and what are the qualifications of the person who will be giving it? Will any of the drugs you are taking, or your allergies, affect your response to the anesthesia?
• In general, what is the success rate for this operation?
• What are the likelihood and nature of complications, if any?
After surgery
• Are there likely to be residual effects from the operation?
• What is the estimated duration of the postoperative hospitalization?
• How long will it take to recover? When can you go back to work? Resume normal exercise? What kind of scar will be left after healing?
• What kind of supplies, equipment, and other help will be needed when you get home?
Choosing a surgeon. If you agree to surgery, choose your surgeon just as you would any other physician (see chapter 24). A good sign of a surgeon’s competence is certification by a surgical board that is approved by the American Board of Medical Specialties. It also helps to find out how many surgeries of the type under consideration the surgeon has performed in the past year. If possible, speak with a friend or acquaintance who works in the hospital where the surgeon operates to learn what the insiders in the hospital think of the surgeon. Hospital disciplinary actions are not made public, but people in the hospital usually have the facts.
Tip. When you sign consent papers for the surgeon, be sure the consent requires that the surgeon be present at, if not actually perform, the surgery. If the papers say “doctor Y or his associates or assistants,” you may end up with the associates or assistants in the operating room, rather than doctor Y. If the doctor wants other doctors to help, the consent should read, “Dr. X and associates” or “and assistants.” The and assures the doctor will be present at the surgery.
Preparing for surgery. Studies show that knowing what to expect before, during, and after surgery reduces anxiety and fear about an operation and even improves overall recovery. Learn about what happens during the operation, what to expect while you are recuperating in the hospital, and what to expect when you return home.
• You will be asked to sign consent forms prior to the procedure. Ask to see the form at least a week ahead of time so you can review it and discuss any problems you may have with it. Before signing, make and initial any changes you want.
• Be sure your advance directives are up-to-date.
• Prepare your home. For example, if the operation will temporarily impair your balance, move throw rugs and otherwise clear paths.
Tip. If you schedule surgery for first thing in the morning, you’ll sleep through the hours you can’t eat.
Limit preoperative tests. Surgery patients are often subjected to a variety of “standard” preoperative tests, many of which may be unnecessary for any particular operation. Ask your doctor to review the suggested tests and limit them to the essential ones. Remind him of any recent tests that were taken before entering the hospital. If blood has to be drawn, make sure they use one sample for all tests that require blood.
11.3 Chemotherapy ↑↑↑
Chemotherapy is the use of drugs to treat a disease, particularly cancer. Because some drugs work better together than alone, chemotherapy may often consist of more than one drug (combination chemotherapy).
You may get chemotherapy at home, in your doctor’s office, in a clinic, in your hospital’s outpatient department, or in a hospital. The choice of where you get chemotherapy depends on which drug or drugs you are getting, your hospital’s policies, and your doctor’s preferences. When you first start chemotherapy, you may need to stay at the hospital for a short time so that your doctor can watch the medicine’s effects closely and make adjustments.
As with any other therapy, you do not have to agree to undergo chemotherapy. However, if you do agree, understand the various drugs that could be used, and their potential side effects.
A comprehensive booklet on the subject is “Chemotherapy and You, a Guide to Self-Help During Treatment,” published by the National Cancer Institute, which covers coping with side effects, eating well during chemotherapy, talking with your doctor and nurse, chemotherapy and your emotions, how to make your daily life easier, and paying for chemotherapy. A free copy can be obtained by calling the National Cancer Institute at 301-496-4000, or write to the National Cancer Institute, 31 Center Drive, MCS 2580, Bethesda, MD 20892-2580 (publication no. 96-1136).
Once you have agreed on a given course, be sure the drug you are receiving is the correct drug. For example, several of the drugs share the letters platin, but the difference in effect can be substantial. Also be sure to follow the prescribed course.
Tip. If possible, schedule your treatments right before the weekend so they interfere with work as little as possible.
11.4 Radiation Therapy
Radiation is a special kind of energy carried by waves or a stream of particles. It can come from special machines or from radioactive substances. Many years ago doctors learned how to use this energy to see inside the body and find disease. A chest X ray or X-ray pictures of your teeth or your bones are examples of the use of radiation. At high doses (many times those used for X-ray exams), radiation can be used to treat cancer and other illnesses. Special equipment is used to aim the radiation at tumors or areas of the body where there is disease. The use of high-energy rays or particles to treat disease is called radiation therapy (also known as X-ray therapy, cobalt therapy, electron beam therapy, or irradiation.)
Radiation therapy is an effective way to treat many kinds of cancer or other disease in almost any part of the body. It is given alone or in combination with surgery, chemotherapy, or biological therapy. A doctor who has had special training in using radiation to treat disease will prescribe the type and amount of treatment that best suits the patient’s needs.
Treatment with radiation can be costly. It requires complex equipment and the services of many health care professionals. Most health insurance policies, including Part B of Medicare, cover charges for radiation therapy. In some states, the Medicaid program may pay for treatments. Financial aid referrals may be available from the hospital (contact the social service office), the Cancer Information Service (800-422-6237), or the local office of the American Cancer Society.
An excellent guide is “Radiation Therapy and You” (publication no. 95-2227), a free booklet available from the National Cancer Institute (see section 11.3). It covers what radiation therapy is, how it works, the risks, what to expect with external or internal radiation therapy, managing side effects, and follow-up care.
11.5 Unproven Treatments
If FDA-approved drugs or treatments are not working, many people with chronic or life-challenging conditions will turn to nonapproved drugs that are often touted as “cures.” The FDA-approved system is not all-seeing and all-knowing, and some drugs not approved in this country may be safe and effective against a specific disease or condition. Or the so-called drugs may just be good old-fashioned rip-offs in new clothing.
Before considering an unproven medical treatment. The FDA notes some red flags to watch out for:
• Claims that the product works by a secret formula.
• Publicity only in the back pages of magazines, over the phone, by direct mail, in newspaper ads in the format of news stories, or infomercials in talk show format (especially with no citation to studies published in credible medical journals).
• Claims that the product is an amazing or miraculous breakthrough.
• Promises of a quick, painless, guaranteed cure.
• Testimonials from satisfied customers.
Additional tips.
• Be careful of what source you use to assess a drug or treatment. Newspaper reports about a new breakthrough may be blown out of proportion. The articles are usually based on a press release from a person or company that has a financial or other interest in the product and on a limited test on a small number of people (such as twenty-five) and/or conducted over a short time. These reports can be used as progress and research markers but not as facts on which to base decisions.
• If you have to go abroad, or if an inpatient stay is required to protect the secrecy of the treatment, be skeptical.
• If they don’t tell you the downside or the unsuccessful-treatment rate, something is wrong.
• If you ask questions of the promoters and don’t understand the answers, have your medical expert talk with them on your behalf.
• If a drug or treatment is experimental, and yet you are being asked to pay for the drug, stay away. Just after the breakup of Russia, I was approached to help enroll clients in a “study” of an electromagnetic device supposedly developed for the Russian military that would “zap” a deadly virus in a person’s body. The data supplied included letters from a doctor in Switzerland and testimonials from satisfied patients. While it was supposed to be a study, participants were to fly to Europe for the test at their own expense and pay “only” $10,000 to participate.
• Contact your GuardianOrg to determine what they know about the drug or treatment.
Insurance. It is unlikely that any unapproved drug or treatment will be paid for by your health insurance. Still, if you want to try such a drug, review your insurance coverage.
Tip. When you look at data regarding an unproved drug or treatment, remember that use of an unconventional treatment may simply coincide with remission or a lessening of symptoms due to completely different factors. The only way to trust results is with a controlled trial that includes enough people over a long enough time. If it sounds too good to be true—it probably is.