New Drugs must be used with caution

29 Oct 2005, The Straits Times

Question

New Drugs must be used with caution

If I had been diagnosed with cancer in Singapore, the chances are higher that I would be dead today. 

I'm sorry if that comes across as alarmist, but we're talking about life and death matters here. 

I consider myself lucky that I was diagnosed with breast cancer in Boston in 2002, where I had been doing my graduate studies. I had access to new, ground-breaking medical treatments fully paid for by my university's health insurance plan. 

In Singapore, access to promising but expensive treatments are sometimes curtailed on grounds of 'cost-effectiveness' and to keep health-care costs down. 

While nobody wants health-care costs to spiral out of control, it's a legitimate question to ask if more public funds shouldn't be devoted to make promising new treatments accessible to patients. 

For example, MediShield wouldn't have paid for the drug I was on. In fact, I would likely never have heard of the wonder drug called Herceptin. 

I would then not have had access to a drug that latest studies released this May show can halve the risk of the cancer recurring and improves survival rates by one-third. 

If I had been diagnosed here and gone through conventional chemotherapy without Herceptin, there's a one in four chance I wouldn't be alive writing this today. 

Thanks to Herceptin, the odds of me being alive today went up to 87 per cent. (I may still die from breast cancer, of course, even with the wonder drug, but that's another story.) 

While my comments are about the Herceptin drug for breast cancer, the point I'm making is about access to promising new treatments in general.

These could include Gleevac (for gastrointestinal tumours and leukaemia) and Eloxatin (colorectal cancer). 

Do patients in Singapore get access to such treatments or drugs? Are these subsidised? 

Are they covered by MediShield? Who decides whether MediShield plans cover such treatments? 

In Britain this month, the National Health Service (NHS) stated it would start testing all early breast-cancer patients to see if they belonged to the 30 per cent whose cancers would respond to Herceptin. 

If they are, NHS would pay for the drug. In fact, Health Secretary Patricia Hewitt has ordered the drugs watchdog body in Britain to fast-track the process of evaluating and licensing Herceptin, to reduce the number of patients who may otherwise die while waiting for the drug to get licensing approval. 

In the United States, Herceptin has been approved for use for advanced breast cancer since 1998. With the news this May that the drug also works against early breast cancer, it's likely to become standard treatment for all, not just advanced, breast cancers soon. 

Will Singapore patients be left out of the race to get access to promising drugs such as Herceptin? 

I fear the answer may be yes. 

First, many patients who might benefit from new treatments don't get a chance to hear about it. 

One doctor said he stopped telling people about the drug, because so few people can afford it. 

Another said doctors stopped testing patients to see if they would benefit from drugs like Herceptin, because it would be cruel to tell someone they might benefit from a new wonder drug if they can't afford it. 

At about $50,000 per year, the drug is prohibitively expensive. 

It's considered an 'experimental' drug and isn't covered by MediShield, so patients have to pay out of pocket for it. 

So even if patients manage to find out about it, they might not be able to afford it. 

What recourse do they have? 

In the US, Canada and United Kingdom, they band together and lobby for it. 

Cancer activists lobby the drug discoverer Genentech and manufacturer Roche to make it available faster, and at a lower price for some people. 

They lobby health insurers to cover it under their plans. They lobby health authorities to make it available as a standard form of treatment. 

Here, concerned doctors and cancer activists aware of the expensive cost of treatment, devote themselves to raising funds to pay for this. 

The Singapore Cancer Society (SCS) raised over $3.2 million from its charity show last week, to help cancer patients. 

There is no doubt that SCS is filling an important gap, and saving lives by harnessing donations. 

At the same time, the public issues involved also deserve an airing. 

Why should new costly treatments be funded purely by private funds? 

To what extent should public funds be used to subsidise costly but promising new treatments? 

Shouldn't MediShield - the overarching health insurance scheme that most Singaporeans are dependent on - cover such treatments? 

What is the criteria used to assess whether a new procedure or drug should be offered as part of the 'standard' package of subsidised services? Who decides this? 

How do they weigh conflicting pressures of keeping health-care costs down and ensuring equitable access to expensive treatments? 

My view is this process should be transparent. Patients and their families, not just doctors and health administrators, should be involved, to balance the interests involved. 

In the Boston hospital where I was treated, Herceptin was offered to all advanced breast cancer patients who might benefit from it. For early breast cancers like mine, Herceptin was available as part of a clinical trial. 

(This was in 2002, and I was part of clinical trials of over 8,000 patients in over 30 countries who contributed to the result announced by the American Society of Clinical Oncologists in May, and written up in the editorial of the Oct 20 issue of the New England Journal of Medicine, available online.) 

In Singapore's public hospitals, as far as I know, patients aren't routinely tested to see if they would benefit from the drug. (I would be delighted to be told I'm wrong.) 

In other words, the drug touted as the most promising for breast cancer, isn't part of the standard menu of options presented here. 

How long would it take for a drug like Herceptin to be offered as part of the standard protocol for treating breast cancer patients here? Or given its high cost, will it always be marginalised into an option only for the rich? 

While Singaporeans want to keep health-care costs down, they should also understand that this keeps out treatments that can save lives. 

Reading about the results of Herceptin online, I did not know whether to be happy or sad: Happy that I benefited personally from it due to the happy coincidence of being at a Boston cancer centre which took part in the clinical trial, or sad because my Singapore sisters may not have a chance to benefit from it.

Reply

Reply from MOH 

We thank Ms Chua Mui Hong ("Costly, but put wonder drugs within reach"; ST, Oct 29) for sharing her insights on her battle with early stage breast cancer. We are happy that she is satisfied with the treatment she received. We would like to clarify Ms Chua's concerns on the use of Herceptin in Singapore. 

Herceptin was licensed in Singapore in 1999 as an anticancer drug and has been available for use by our doctors since then for the treatment of patients who have advanced stage breast cancer that has spread to other parts of the body and in which the cancer has an excess of HER2 (Human Epidermal Growth Factor Receptor 2). 

Recently, in experimental trials, this drug has shown effectiveness in patients with early stage HER-2 positive breast cancer. Data from the trial showed that Herceptin could improve survival rate at 4 years by 5% (from 86% to 91%). The figures for patients alive and disease free is more promising. But the benefits of Herceptin must be weighed against the estimated risk of heart failure. Based on data from the same clinical trial, up to 4% of patients treated with the drug developed severe heart failure and another 14% were noted to have a drop in heart function. 

International regulators such as the US FDA (Food and Drug Administration) and EMEA (European Medicines Agency) have not licensed the use of Herceptin for early stage breast cancer patients as they need to make an independent assessment of the trial data. 

New drugs must be used with caution. The experience with Vioxx should be a lesson for all to heed. There was enthusiastic anecdotal endorsement of Vioxx by many patients. But because of complications related to the drug, Vioxx was withdrawn from the market. Therefore, before we endorse the widespread use of any new drug, as a routine practice, we must evaluate all the information carefully and be cognizant of the clinical limitations and possible long term effects of the drug. Otherwise, we could inadvertently be putting our patients at risk.