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New drug offers hope for multiple schlerosis victims

FDA reverses medication ban; benefits outweigh side effects for some
by: JIM CLARK, Tammy Baker (middle, with daughter Ashley and husband Steve) used Tysabri during its brief release a year and a half ago. She says the drug helped her to walk again.

Tammy Baker was diagnosed with multiple sclerosis in 1996, two years after her daughter was born. Within three years, Baker, a mortgage banker who lives in Garden Home, had begun to lose her memory and could no longer work.

By 2004, she had lost the ability to walk and depended on a motorized scooter to get around. Today, even talking is difficult, so difficult she often asks her husband, Steve Baker, to speak for her.

There's a drug, Tysabri, that probably could get Baker out of her scooter and walking again, that probably would put all of her symptoms in remission. But there's a catch - it just might kill her.

The Food and Drug Administration last year pulled Tysabri from the market, after discovering the drug may cause a fatal brain disease in a small percentage of users. But in a rare reversal of that earlier decision, the FDA last month decided that the benefits of Tysabri may be worth it for people like Baker and approved re-releasing the drug. (Last week, the European Union followed suit and approved the drug for release in the 25-nation bloc.)

It's only the second time the FDA has made such a reversal, and points to the uneasy ground on which the medical profession continues to work - trying to make the moral judgments about the availability of therapies that can benefit patients and at the same time be a risk to their health.

The reason Baker is so certain Tysabri will help her is she took Tysabri before. She took it for two months in late 2004. She walked again; her memory came back. 'It was like a 180-degree turnaround in two months,' her husband says. It was like a miracle, he says.

Stories like Baker's began to spread throughout the country.

Nevertheless, the FDA withdrew Tysabri from the market in February 2005 because of the incidents of Tysabri patients getting the rare brain disease. On June 5 this year, however, the FDA decided to re-release the drug, after further study and testimony from disease sufferers desperate for Tysabri.

And that, Baker believes, is as it should be. In the year since Tysabri was withdrawn, her disease has progressed even further.

'When nothing else is working, we're willing to take that risk,' she says.

Side effects create dilemma

Dr. Stanley Cohan, medical director of the Providence Multiple Sclerosis Center, has had patients calling every week for the last year, wanting to know when they can get off their other medications and begin taking Tysabri.

As of this week, Cohan has an answer from the drug's makers: In September he and other local neurologists will be shipped a new supply of Tysabri. And they'll have a dilemma of their own to confront. The Providence center, for instance, treats about 1,000 multiple sclerosis patients. But initially Cohan will be able to treat only about 50 with Tysabri.

Cohan had about 25 patients on Tysabri before the drug was withdrawn, and he says all showed remarkable improvement after other medications had failed them. Still, he says, he supported the FDA's decision to withdraw Tysabri last year, and he's glad the drug is back with a little more research showing the rate of serious side effects probably is tolerable. Treating multiple sclerosis patients every day has provided him plenty of opportunity to appreciate the ethical choices involved with Tysabri.

'Every patient who participates is putting their life on the line,' Cohan says. 'It's a matter of striking a balance between what risk they're willing to take and the benefit they're likely to expect.

'Ultimately it's up to the patient,' he says.

But it isn't always. The FDA didn't leave the choice up to patients when it withdrew Tysabri. And Cohan says the agency isn't all that much more knowledgeable now.

All he can do, Cohan says, is tell patients what he knows about Tysabri, that three people out of about 3,000 who took the drug for relapsing multiple sclerosis contracted progressive multifocal leukoencephalopathy. That is a rare, untreatable brain disease. Two died; the third became seriously disabled.

But there are countless unknown variables, such as how Tysabri might interact with other multiple sclerosis drugs, and whether it was such a combination that caused the brain disease in the three original patients.

'We really can't tell the patient what the risk is,' Cohan says. 'We don't know what the risk is.'

Side effects are expected with any medication battling multiple sclerosis, says Candyce Hayes, executive director of the Multiple Sclerosis Society of Portland. Sometimes the side effects are tolerable, she says, and sometimes not.

'The truth of the matter is all the MS drugs have side effects,' Hayes says. 'The saying is the first 10 years you swear at the medication and the 11th year you swear by it. But a lot of people don't make it to the 11th year because of the side effects.'

Further monitoring needed

Mary Ann Baily, bioethicist and health economist for the Hastings Center bioethics research institute in New York, says the question of whether a drug such as Tysabri should be brought to market obscures a more important question: how such drugs are brought to market.

'The FDA is working in a world in which there are these up or down decisions,' Baily says. 'There's a more subtle question, which is what is the responsibility of the health care system to develop better information about who is at risk and who isn't.'

Baily says the pharmaceutical industry should be learning more about drugs before they are released, and also after they are released. But that doesn't happen, Baily says, because there's no financial incentive for drug companies to find out which patients benefit the most from their drugs.

'We don't have a systematic ongoing way of determining the ongoing benefits and costs and side effects of drugs after they're introduced,' she says.

Baily says what is needed is a central registry to monitor patients taking new drugs after release to determine who is suffering side effects and under what conditions. Because it apparently caused deaths, Tysabri is being treated in exactly that way.

Under the terms of Tysabri's re-release, only physicians willing to perform extra tracking will get access to the drug. Physicians must go through a series of checks with each patient before injecting the drug each month, and Tysabri is to be prescribed only for patients who are not taking other drugs intended to alter the course of the disease. Ironically, one of Tysabri's manufacturers, Biogen Idec, had hoped to sell the drug to be taken along with another medication.

But there's a tradeoff involved in having physicians such as Cohan do all the extra tracking. The extra work - added paperwork, extra time with each patient explaining the risks, additional tests to look for side effects - are what will keep him from being able to treat more than 50 patients over the next year.

MS can go undiagnosed

Cohan's center, located at Providence-St. Vincent Medical Center, is precisely the type of place set up to conduct monitoring of Tysabri. That's because the staff there has as its specialized expertise the diagnosis and treatment of multiple sclerosis.

It's an expertise Cohan says is lacking throughout much of the state. He says that across the nation, the overall diagnosis and treatment of multiple sclerosis is 'deplorable.'

For example, Cohan says, he has six multiple sclerosis patients from Fossil, and all were told by their local physicians that nothing could be done for them. 'None of them were getting care,' he says, pointing out that he often sees patients who have had undiagnosed multiple sclerosis for years.

'We have patients who show up in ER because they're in auto accidents, and they have MRI scans of their brains and they have MS.'

Multiple sclerosis has always been a difficult disease to diagnose. Symptoms vary and often go into remission. But those excuses just tend to anger Cohan, who says many physicians, especially those in rural areas, simply aren't aware of the latest advances in multiple sclerosis diagnosis and treatment.

Cohan wants his registry to serve as a regional resource so that patients and physicians throughout Oregon can gain access to state-of-the-art treatment, and also collect data that can help researchers learn more about the disease.

Dawn, a nurse from a small town outside Portland, is one of Cohan's patients. She has asked that her real name not be used.

In 1982 Dawn suffered her first episode of vertigo. The room began to spin and a sensation she describes as little electrical shocks coursing through her body began to come and go, she says. Over the next 10 years she began getting weaker, occasionally tripping over the smallest impediments. She saw a number of physicians and had MRIs performed. Her symptoms worsened, but it was not until 1998 that a neurologist diagnosed her with multiple sclerosis.

Cohan provided her with Tysabri during its first release. Dawn says her symptoms improved - the buzzing and twitching she'd been experiencing mostly disappeared. Her vision, which had greatly failed, returned almost to normal.

'It's hope - that's what Tysabri means to me,' she says. 'It's going to help me keep things I'm really close to losing - being able to walk, staying employed full time, which helps me keep insurance and independence and income.'

As for the risk of taking Tysabri, Dawn says she would probably opt for the drug if her risk of a fatal brain disease were 10 times the predicted 1 in 1,000.

'For me, the benefit is worth any risk,' she says.

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