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Family Health Magazine - PHARMACY CARE

New Treatments, New Hope
How biological response modifiers work with your immune system

Recently a remarkable new class of medications called biological response modifiers has been added to the world of medicine. These medications modify the way the body’s immune (defence) system responds to threats to health. The new drugs can treat a wide range of conditions, including rheumatoid arthritis, inflammatory bowel disease and some cancers. The brand names Enbrel™, Remicade™, Humira™, and Betaseron™ may be familiar to you. There are many others.

These new medications modify the way the body’s immune (defence) system responds to threats to health.

There are many different types of biological response modifiers. They all work on the immune system at different points and in different ways. Some block certain parts of the immune system. This is very helpful when treating conditions where the immune system is not working properly. Others stimulate the immune system, and are useful in treating certain forms of cancer.

Your body’s defender

The immune system does the very important job of protecting the body from outside invaders like bacteria and viruses. It must protect every spot in the body. It must also be able to tell the difference between what should be attacked and what should not.

Unfortunately, at times the immune system is not as precise as it should be. We do not yet know exactly why it malfunctions. Sometimes the immune system becomes overly sensitive, responds much more strongly than it should, or does not turn itself off. Sometimes it suffers from all three problems. Joints, bowels, skin and other areas can all come under attack. When this happens, the immune system can actually damage or injure parts of the body. Such diseases are called autoimmune disorders. Rheumatoid arthritis, inflammatory bowel disease and psoriasis are some examples. They are very disabling, painful, and can severely affect quality of life.

Standard treatments for these conditions have serious side effects. It can take months of treatment to see improvement. If no improvement comes or side effects become too severe, different treatments may be prescribed. This can be a difficult choice for patient and doctor, as it can come down to living with the disease or with side effects of treatment. Biological response modifiers will sometimes improve the outcome of treatment.

Cancer treatment is another area where biological response modifiers are being used. Although new, they are being used more and more, usually in combination with other treatments. They can slow the growth or spread of cancer or boost the immune system’s effectiveness in fighting it.

Great advances have been made in medicine and research. Yet it is startling to realize how little we know about the human body. All the body’s systems mesh together so closely that small changes can have large effects. At the same time, some very large changes are easily absorbed and the body continues to function as before.

New treatments – who is watching?

New treatments go through many years of testing and trials before they are approved. Even with such results, we keep learning. As more patients begin taking these medications, information is gathered on both good and bad effects. Health Canada continually receives information from across the country.

If Health Canada thinks health professionals should know something new and important, they will send out an information bulletin. These notices are also available to the public at www.hc-sc.gc.ca. Search under ‘Drugs & Health Products’, then click ‘Advisories, Warnings & Recalls.’

Sometimes notices report new side effects. Others mention only a possible problem with a medication or treatment. This information must be weighed against the potential benefits. Every treatment has positive and negative aspects. These must be considered by the doctor and patient. Biological response modifiers are no different.

Medication costs - an important issue for discussion

In Canada, medication costs are covered by private insurance plans, provincial drug plans, and, in some cases, assistance from pharmaceutical manufacturers. Each province manages its own provincial drug payment plan. You might assume that these plans are similar from province to province. In fact, provincial plans differ in many ways. How much is covered, what deductibles are to be paid, who is covered, and the process of applying for coverage differs in each province. There is no link between provinces.

Many companies making these expensive medications have set up a help centre for patients to call. This service can help in navigating the system. Even so, some people still cannot afford the high cost of these new treatments.
Why do these medications cost so much? This is a common question, not just about biological response modifiers but for many other medications and treatments. The answer is complicated.

Pharmaceutical companies say that only one out of every 10,000 substances investigated ever makes it to market. It costs on average a billion dollars and 10 to 12 years of research to develop a new, useable product.

The number of people needing a product will affect how much of the cost of development will be recovered. If a disease is rare, very few people will require the medication. This means it costs more. The length of time a product is covered by a patent also comes into play when deciding on cost.

The argument has been made that pharmaceutical companies make too much profit and prices should be lower. Companies argue that without profits, no investment will be made in their companies. Without investment money, research into new products would suffer.

Ethical and economic arguments further complicate the issue. For instance, would it be better for government to fund an expensive medication if it saves the health care system money in a different area, such as the cost of hospital stays? What would we do if the cost of medication becomes so high that it forces the system to cut back on other essential services? These difficult issues must be discussed. Talk to your provincial and federal government representatives about these issues. Let them know this is an important topic that should be raised with the government.

Treatment issues

Biological response modifiers cannot be taken in pill or liquid form. They must be injected or given by IV infusion (into a vein). Some products come in a pre-filled needle. Many people can learn to inject themselves at home. Others get help from a family member. If you have poor eyesight or cannot use needles on your own, you might need assistance. Such help may not always be available or practical. With a product that can only be given by IV infusion, a hospital visit or a home care service (if available) is often needed.

Spacing for injections varies from two injections per week to one injection per month for some newer products. Of course, most people would prefer a smaller number of injections, but the products may not be interchangeable. Some are only approved for certain conditions. There is also little data on the effects of switching from one product to another. Unless your current product has side effects or is not giving the results you want, it may be best not to change what is working.

The cost of medical care has always been a subject for heated debate. Biological response modifiers can cost over $1,300 per month. Usually a product that must be given twice a week has about the same cost per month as a product given once a month for a similar condition. Occasionally, a doctor may find it necessary to increase the amount of medication given, especially at the start of treatment. This increases the cost. (See sidebar for a discussion of cost issues.)

Side effects are a concern with any treatment. Talk to your doctor about risks and benefits of these medications. It you want more information on any medication and its possible side effects, talk with your pharmacist.

Occasionally, a media report will highlight new information about a condition or medication. Most media outlets have very high standards and do their best to give accurate information. However, with the explosion of available information including the Internet, it can be hard to know what is true. Talk to a trusted health care provider about information you have seen or heard. A pharmacist is a good choice. They can usually tell quickly whether the information relates to you.

The body is a marvelously complex machine. The new biological response modifiers are an amazing discovery that will help us to treat some serious conditions. As we keep using these products, we will find out even more about how they affect the human body.