Only a day after the results of two Phase III clinical trials involving Novartis’s oral therapy for multiple sclerosis (MS) were published in The New England Journal of Medicine (NEJM), the media has leapt on the positive trial data and hailed the therapy as “hope for MS patients” that can “dramatically reduce relapse”. That’s great news, but hold on… the therapy hasn’t even been approved yet!
On the plus side, the therapy, FTY720 (fingolimod), is definitely an important breakthrough because it can be administered orally. Currently available MS treatments must be administered via injections or infusion, which seriously hampers patient compliance — some experts suggest that as many as 50% of patients do not receive treatment or self-medicate because of fear and anxiety over the treatment process. In this respect, an oral therapy would certainly be beneficial.
The trials have also generated some promising data that supports the efficacy and safety profile of the therapy. According to the NEJM: “The studies showed that fingolimod halved the number of disabling relapses experienced by people with MS and reduced disability progression by almost a third.”
It’s great news, but my problem is the sensationalist headlines in the consumer media that generally follow such significant scientific announcements. These news items that appear in print, radio and television press, naturally simplify the science but they sometimes give false hope to sufferers of incurable conditions who are desperately searching for a cure. Many of these reports also gloss over some of the more negative aspects concerned with the treatment; opting not to provide a balanced view of the new therapy and instead focusing on building patient expectations. Can any treatment for any condition ever live up to this media sensationalism? Here are some of the headlines I’ve come across today:
Will we not learn?
Let’s look at Avastin as an example. Genentech and Roche’s blockbuster was introduced onto the market in 2004 after trial data demonstrated it could prolong survival by approximately 5 months in colorectal cancer patients. The drug aroused massive media hype that touted it as a “revolutionary” new cancer therapy. Don’t get me wrong, Avastin marked a turning point in the treatment of cancer; it was the very first angiogensis inhibitor ever approved. Its launch marked the first of a number of drugs to act via similar mechanisms of action, not only for the treatment of cancer, but also for various blinding ophthalmic diseases. Therefore, when Avastin was approved for the treatment of cancer almost six years ago, its manufacturers, Roche and Genentech, had high hopes.
Indeed, it has delivered on many levels; however, the agent has also suffered a number of setbacks. For instance, in 2009 the treatment failed a Phase III trial for preventing early-stage colon cancer. Also in 2009, a Phase III study of Avastin in patients with advanced breast cancer did not meet its primary efficacy endpoint.
A quick scout around the internet also reveals that several people are examining whether Avastin has lived up to the hype created in 2004, such as an article from Forbes titled Is Avastin Living Up To The Hype?
In an article published in 2008 in the New York Times, a colon specialist at the Memorial Sloan-Kettering Cancer Center (NY, USA), Leonard Saltz, was quoted as saying: “I still use Avastin routinely, but it’s sobering. It’s not a slam dunk and, in fact, the incremental benefit may be more modest than we want to admit.” I believe this has little to do with the lack of efficacy of the agent — its manufacturers never claimed it could work miracles — but it has more to do with the unrealistic expectations created by the press, with some even calling it a “magic bullet”.
Is fingolimod doomed to follow the same path? After a quick glance at the fingolimod headlines littering the media today, you could be forgiven for thinking the treatment is a cure, which it isn’t. As with previous treatments, the therapy reduces the symptoms rather than curing the actual disease.
I probably appear extremely pessimistic after writing this post. As a journalist though I see a lot of information and press releases about potential new treatments for cancer and other life-threatening disease — many in the very early stages of research. It’s painful to think that these may often give desperate patients false hopes.
Believe it or not, I do believe that if an oral therapy for MS were to be made available, that would be fantastic news and would mark a real turning point in the treatment of this debilitating condition for patients and practitioners. But for the sake of MS patients, let’s hope that fingolimod can meet the high expectations that have already been set by consumer press. The treatment has not yet been approved by the EMA or the FDA, but was submitted to both agencies for regulatory approval in December 2009.
Meanwhile, Merck KGaA also hopes to grab a slice of the action with its own investigational oral treatment for MS — cladribine. Having completed Phase III testing, the company is currently working with regulators following an announcement in November 2009 that it had received a refuse to file letter from the FDA on its New Drug Application. For now, it’s a two-horse race; whether its Novartis or Merck KGaA that makes it to market first, patients and healthcare practitioners around the world are sure to welcome it with open arms.