Last week, Biogen and Elan Pharmaceutical withdrew their joint blockbuster drug, Tysabri, from the market. Tysabri treats multiple sclerosis, and it had been widely awaited for release to the market by MS patients. Taking the drug off the market was not a wholly unreasonable decision as two patients who had taken Tysabri for over two years in clinical trials (in conjunction with another drug developed by Biogen) had developed progressive multifocal leukoencephalopathy (PML), one of whom has died. As may be expected, stock prices of both companies were effected by the announcement of the drug's withdrawal.
This goes beyond mere stock prices of sales, though, and gets into the issues of how do we determine which drugs are "safe," what is our definition of "safe," and the next generation of bioscience development.
One aspect of determining the safety and efficacy of a drug that I've always found to be fascinating is how many and what kinds of adverse reactions are considered. This usually comes down to percentages, though having a fatality in a trial is really bad. Here, the situation is more complex where each of the patient's contracting PML was also taking another drug ... so, is it the drug combination to blame? Something entirely other than the drugs (i.e. the patients would have developed PML on their own not matter what, or due to another environmental/biochemical factor)? One of the drugs?
Are we reasonable to ask for drugs to have no negative side effects? To ask for no drug to kill any person?
We are all different humans, after all, with very similar yet different genetic makeups, and with different environmental factors. So can there really be a "one size fits all" standard for drugs?
We all lead busy lives and are inundated with gigabytes worth of information every day ... it's enough to constrain the bandwidth of any person. Throw in an illness that leaves us mentally and emotionally vulnerable, and all we want to hear is that "this pill will make you all better." So we start to demand that of any drug - no risks, no vulnerabilities, just pure guarantee of return to health.
If only it were that easy. If we did that in all aspects of our lives, we'd be driving in tanks and walking around in Michelin-man type suits. Unfortunately, there are few things in life that will treat everyone. To paraphrase the famous phrase, you can't treat all of the people all of the time. Even aspirin will upset some people.
I think Biogen and Elan did the prudent thing here. They are suspending their product to get some more information on what might have lead to the development of PML in those patients. It may or may not have had anything to do with their drug, but they should find out so they can warn other patients who may exhibit certain similar symptoms or behaviors as those who, unfortunately, were stricken with PML. If they can figure out why those 2 patients developed PML, and be able to warn others at risk, they will have done a great thing by putting their drug back on the market to help those who can benefit.
This leads, though, to what will be the future of pharma. I had the privilege of chairing the Bioscience Legislative Dinner held by the Idaho Bioscience Association (bioIdaho) this past Monday. One of our keynote speakers was G. Steven Burrill of Burrill and Company, and he just blew the audience away. Among his key points, he revealed one of the upcoming important developments in the biosciences - assays and diagnostics (including software and biological tests) that will be able to predict which populations will benefit from and which should stay away from a certain drug. Coming up with these better diagnostics could not only save pharma companies millions (or billions) in marketing campaigns, misplaced sales and lawsuits, but they could save payors, Medicare/Medicaid and states billions of dollars from the purchase of drugs that don't actually help the patients. There are some companies in the early phases venturing into this territory, and all pharma companies would likely be well-advised to looking into this sort of research that complements their ongoing trials.
I share your opinion that it is almost impossible to release a drug which has no side effects. I also like to revisit old stories to see how they evolved over the years. Like in this case, the withdrawal of Tysabri. I know that many MS patients were sad about the withdrawal since they obtained some excellent results with the drug, and despite the PML complication they were willing to take those chances. Today the drug is a highly popular among MS patients and with the company's latest release of the JCV antibody test, which finds patients more susceptible to PML complications, their sales will surely rise. This latest development is a good news for the patients and the company as well.
Chris from progressive multifocal leukoencephalopathy treatment.
Posted by: Account Deleted | April 16, 2012 at 09:51 AM