Arthritis sufferers have to balance the pros and cons of new medications
Free medication gave Rose Balan a taste of a better life. Balan, now 47, has had rheumatoid arthritis for 32 years. Traditional medications can no longer suppress the searing pain and chronic swelling in her joints. Only something new and powerful would do the trick. In July, 2000, Balan began taking an experimental drug called Remicade, andit worked like a miracle. “As soon as I started on Remicade, I felt no stiffness, no fatigue,” she says. “I felt normal.” Better yet, the therapy didn’t cost a cent. For a year and a half, Balan, a single Grade 1 teacher in Merritt, B.C., received complimentary infusions every six weeks from distributor Schering Canada Inc. under a special access program set up before Remicade received approval for sale. But last fall, Health Canada gave the drug its green light, and the special access program came to an end.
That left Balan having to find the $29,000 a year it would cost her to keep taking the above-average dose of Remicade she needs. Even warnings of potentially dire side-effects couldn’t dampen her resolve. “There are no other medical options open to me,” said a panicky Balan last November as the effects of her final free infusion wore off. “I can’t just stop.” She wrote letters and made phone calls urging decision-makers at the government and her private drug plan to cover the cost of Remicade. A ray of hope came just before Christmas: her employer’s insurance plan will pay almost half her Remicade costs, enough for her to resume treatment. Balan has no idea how she will raise the rest, but she’s pleased to get a reprieve. “I’m operating month to month right now,” she says.
Balan’s plight illustrates a mixed message emerging from new developments in arthritis treatment: while hot new drugs are exploding onto the scene and providing hope for Canadians suffering pain and disability, all that glitters is not necessarily gold. The new drugs are wildly expensive, they’re only meant for the sickest patients for whom other treatments have been unsuccessful, and they are still experimental. Patients should remember, too, that behind every drug lurks a massive marketing machine.
In the case of Remicade, Schering has faced accusations of luring patients like Balan into its sales scheme. In November, the CBC-TV program Disclosure accused the company of giving desperate patients a free taste of Remicade so they’d be eager to keep using it when the special access program ended, and would then lobby their governments and private drug plans to get it covered. Getting Remicade onto provincial lists of approved drugs—known as formularies—could be worth billions of dollars for Schering, said the CBC.
Schering, however, calls the CBC report misleading. In fact, says company spokesman Randy Steffan, Schering gave out $55 million worth of Remicade on a compassionate basis. “The special access program was not a marketing program,” he says. “It was a legitimate access program for patients with serious or life-threatening illness.”
Dr. Dianne Mosher, president of the Canadian Rheumatology Association, agrees. “It wasn’t that Schering created the special access program,” she says. Such programs are set up by Health Canada to week to allow sick people access to promising drugs that have undergone testing but are still awaiting government approval for sale. “Without special access, many patients would not have received therapy until much later,” says Mosher. “Clearly it was a huge benefit. I’ve had patients who have called crying, saying, ‘They can’t make me go back to the way I was.’ ”
But that’s just the kind of emotion that helped Schering fuel its marketing campaign, says Dr. Jim Wright. An expert in clinical pharmacology and internal medicine in Vancouver, Wright is managing director of the University of British Columbia’s Therapeutics Initiative. That drug assessment working group evaluates various new medications for possible inclusion in the B.C. government’s drug benefit program. Wary of the power of pharmaceutical companies, Wright feels patients and organizations are being influenced with the intent of boosting drug sales. The Arthritis Society, for example, accepts about $2 million a year from pharmaceutical companies, including Schering, and it actively encourages patients to lobby for better access to Remicade and another new breakthrough arthritis drug, Enbrel.
Wright worries that the society’s enthusiasm for these drugs may have been swayed by the money it receives. “They get a huge amount of money that puts them in a potential conflict-of-interest position,” he says. The Arthritis Society, however, is unapologetic about urging arthritis sufferers to lobby. “It has nothing to do with the companies,” says president Denis Morrice, based in Toronto. He says the question the society asks is whether a drug would help patients. If it would, he adds, “then well make sure they get it.”
Enbrel and Remicade are known as biologics, drugs which work by blocking a chemical called tumour necrosis factor alpha (TNFa), which inflames joints. Although Morrice calls them “the biggest advancements in 100 years,” they are not panaceas. They’re intended only for patients with moderate or severe rheumatoid arthritis for whom other therapies aren’t working. Their long-term effects are not known, as they have been in use for only about two years. Having recorded a few hundred fatalities worldwide among patients on biologics, the U.S. Food and Drug Administration has warned that people with certain pre-existing infections (most commonly tuberculosis) or heart conditions should not take them. But side-effects are common with all rheumatoid arthritis drugs, says Dr. Christopher Penney, a rheumatologist at Rockyview Hospital in Calgary. “The side effects are no worse than those from any other drugs we are using,” Penney says.
Lynn MacAskill, whose rheumatoid arthritis flared up so badly more than two years ago that she was bedridden for 15 months, says when you’re in that much pain you’ll try anything. “I was desperate,” says the 46-year-old Edmonton secretary. “Honest to God, I took 100 Tylenol 3s in one week. I said, ‘I can’t live like this. Just give me something.’ ” Last November, MacAskill started taking Enbrel, which is covered under her private health benefits, and she’s feeling well.
Arthritis affects four million Canadians. About 300,000 of them have the most disabling form, rheumatoid arthritis (RA), an autoimmune disease in which the body attacks itself. The cornerstone of treatment for RA has long been the disease-modifying anti-rheumatic drugs (DMARDs) such as Myochrysine, commonly known as injectable gold, and methotrexate. Although they all have side-effects, their success rates are well established.
Clinicians prescribe nonsteroidal anti-inflammatory drugs (NSAIDs) such as Aspirin, Motrin and Advil for many types of arthritis to reduce joint pain and swelling, but those drugs have been associated with stomach ailments. New NSAIDs, introduced in Canada in 1999, are the selective cyclo-oxygenase (COX-2) inhibitors, sold as Celebrex and Vioxx, which appear to carry less risk of serious gastrointestinal problems.
One of the biggest challenges in arthritis treatment in Canada is the inconsistency in drug coverage policies from province to province. Vioxx provides a good illustration. Alberta, Manitoba, Quebec, Nova Scotia and Newfoundland have included it in their formularies without restrictions—meaning patients receiving provincial benefits get it free. New Brunswick covers it for those over 65. British Columbia, Saskatchewan and Ontario list it with more restrictions, and Prince Edward Island has not yet made a decision on Vioxx coverage.
Dr. John Fitzsimons, a family doctor in Bradford, Ont., finds his province’s limitations on prescribing the COX-2 drugs infuriating. Under Ontario’s rules, any physician who wants to prescribe Vioxx has to establish that the patient has not improved on at least three other NSAIDs or had significant ulcer or gastrointestinal bleeding. “We have to put our patients at risk to meet government criteria,” he says, “and I find that objectionable. When they have managed to live through all that, then they are allowed Vioxx.” The problem, he points out, is that “once they start to bleed, they could die.” According to the Arthritis Society, almost 2,000 Canadians bleed to death each year from NSAID-related complications.
With the new biologics on the scene, access problems have magnified. Saskatchewan and Ontario are the only provinces so far to put Enbrel and Remicade on their formularies. One reason for the other provinces’ reluctance could be the drugs’ cost. About 213,000 Canadians have arthritis severe enough that they might qualify for Enbrel or Remicade. In the unlikely case of all of them being prescribed the new drugs, the overall bill— split among provinces, private insurance and individuals—could mount to almost $4 billion per year.
Approval of the COX-2 drugs in 1999 brought a stampede of demand. “ They took the market by storm,” says Dr. Asiam Anis, an expert on formularies from the department of health care and epidemiology at the University of British Columbia in Vancouver. Annual spending on NSAIDs almost doubled across Canada that year, from $44 million in 1998 to $78 million.
Doctors, meanwhile, are caught between the agenda of the provinces—keeping costs down—and pressures by manufacturers and patients to get the new drugs into common use. Dr. John Kelsall, a rheumatologist at St. Paul’s Hospital and the Mary Pack Arthritis Centre in Vancouver, has been prescribing Remicade and Enbrel sparingly, recognizing they are “horribly” expensive. “This onus is upon us,” he says, “to use the old-fashioned medications that are tried and true. But for a significant number of rheumatoid arthritis patients the new biologic drugs are revolutionary. They work for a lot of desperate people. They change lives.”
Still, UBC’s Wright is skeptical. “Yes, some patients have really improved, but for how long?” he wonders. “There appear to be serious toxicities and it will take time to know the magnitude.” Wright advises arthritis sufferers to hold off if they can. “It would be better if you can hang in there before you submit to the experiment.” The enormous relief these new drugs have offered to people like MacAskill and Balan is undeniable. Kelsall is glad to be able to offer his sickest patients these drugs, even though he’s not sure if Scherings motives with the special access program were totally altruistic. “We gladly accept the free drugs,” he says. “They want us to have a taste, to create a stir and then people will lobby.” On the other hand, he says, the benefits are huge. “Ultimately it is for the better; we can offer choices.”
Balan likens her free access to the work of missionaries. “Missionaries bring food, medicine and the word of God to developing countries,” she says. “While they’re intent on bringing people over to Christianity, they are providing other benefits, too. Here, the overall goal is to make money and get these drugs into wide use among patients, but in the end they are doing good by that. Does the end justify the means? I don’t know. For me, it was a lifeline.” *
Should the sickest patients be allowed free access to promising but unapproved drugs?
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