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Greed Trumps Common Sense Once Again, Courtesy Big Pharma

Posted Nov 09 2011 1:02am

Image by Images_of_Money via Flickr

The mix of money and medicine often makes for a strange brew. Far too often, conflicts arise between what is best for the patient and what is best for the bottom line. Over the last several decades, treating chronic illness has mushroomed into a worldwide multibillion dollar industry. To the megacorporations reaping these profits, patients are seen first as consumers, rather than sick individuals needing to be healed. This truth is often camouflaged with warm and fuzzy programs designed for patient outreach and education, but CEOs of publicly traded medical corporations, as mandated by law, are beholden to their shareholders, not to the patients consuming their company's products, a mission which is sometimes at odds with what should be the goal of all involved in the healing professions: the curing of illness and the alleviation of suffering.

We see this unfortunate circumstance play out time and time again in the world of multiple sclerosis. Since Big Pharma finances the vast majority of medical research done in the USA, promising therapies with little profit-making potential are left to wither on the vine. Thus, medical research increasingly involves only therapies that stand to attain blockbuster status. We therefore have very little scientifically reliable data on the effectiveness of Low Dose Naltrexone, dietary supplements, acupuncture, naturopathic remedies, and other largely benign practices and substances. Alternative theories about the disease, such as CCSVI, are met with a fusillade of negativity instead of intellectual curiosity, as might be expected in the case of a disease as intractable as multiple sclerosis.

One of the oddest examples of the profit motive trumping common sense involves the drug Rituxan ( click here ), a compound first formulated to battle B cell non-Hodgkin's lymphoma, for which it was approved by the FDA in 1997. Rituxan was the first monoclonal antibody used to fight cancer, and proved to be both safe and effective in that role. The compound works by destroying B cells, one of the major components of the human immune system. Therefore, in addition to its lymphoma fighting abilities, Rituxan is a powerful immunosuppressant. Due to these immunosuppressive properties, the drug was tried with varying degrees of success on a number of autoimmune diseases, and has been approved for use in patients suffering from rheumatoid arthritis.

Several years ago, clinical trials were started testing Rituxan's efficacy in fighting multiple sclerosis. These trials included not only RRMS patients, as is typical of MS trials, but also PPMS patients, a population for which there are no approved therapies. Phase 1 and 2 trials showed the drug to be extremely effective, dramatically reducing the amount of enhancing lesions seen on patient MRIs, and cutting by half the number of relapses experienced by RRMS trial subjects ( click here ). The trial results were at least equal to those seen with the drug Tysabri, which to date had been the most effective MS drug on the market. Rituxan had the added advantage of having a long history of use, which showed it to have a much lower incidence than Tysabri in expexposing patients on the therapy to to the possibility of developing PML , a sometimes fatal brain infection. Trials for PPMS were not as successful, although analysis of the data did seem to indicate that a subgroup of PPMS patients did appear to benefit from Rituxan therapy ( click here ).

So, it would seem that all systems were "go", and that Rituxan would be quickly shepherded into phase 3 multiple sclerosis trials, the final step needed before FDA approval to go to market, right? Well, this is where things go a little bonkers. It turns out that Rituxan's patent is due to expire in 2015, meaning that the company that makes it, Genentech, will no longer have exclusive rights to the drug, and generic versions of it could come on the market, esseessentially stripping Rituxan of its profit-making potential. Because of the complexity involved in making monoclonal antibodies, it was at first thought that the production of generics would be too costly to be seriously considered, but other companies, sensing opportunity, did indeed step into the arena ( click here ). Given this situation, despite the great promise shown in the earlier trials, Genentech pulled the plug on further MS Rituxan trials. Nevermind that Rituxan appeared to be safe and effective in alleviating some of the suffering caused by a dread disease, there was no money to be made from it, so any further development hit a brick wall.

Instead, Genentech did some tinkering with the production methods used to make the drug, and came up with a compound called Ocrelizumab ( click here ), another monoclonal antibody that destroys B cells, which was quickly put into clinical trials for rheumatoid arthritis, lupus, multiple sclerosis, and hematological cancers. By developing this new compound, so similar to Rituxan, Genentech was insured of maintaining exclusive rights to the drug for several decades, with no threat to the tremendous profits a drug equally as effective as Rituxan could generate. Ah, but the best laid plans of man sometimes go awry, and things didn't work out quite the way Genentech intended.

In 2010, Genentech was forced to suspend Ocrelizumab trials in rheumatoid arthritis and lupus due to deaths resulting from opportunistic infections attacking trial participants ( click here ). Of course, this was a tremendous blow to Genentech's wily plan to circumvent Rituxan's patent issues ( click here ), and a serious kick in the bottom line. But, alas, all was not lost, as trials continued testing Ocrelizumab's use in multiple sclerosis. Recently released phase 2 clinical trial results have shown Ocrelizumab to be highly effective in reducing enhancing lesions and relapses in RRMS patients ( click here ), and Genentech is now in the process of recruiting patients for phase 3 trials for both RRMS and PPMS (click here , here , and here ). Apparently, the perception is that tolerance for risk is higher in the MS population than it is among lupus or RA patients, so it's full speed ahead, torpedoes be damned.

Rituxan is currently still on the market, often used off label for the treatment of MS, and has proven to be very effective in relieving some of the suffering of RRMS patients. Unfortunately, since it is not FDA approved for use in MS, many insurance companies refuse to pay for it, as it is an extremely expensive therapy (over $40,000 per year). Once the generics do hit the market in several years, the price of the drug should plummet. Should Ocrelizumab pass its phase 3 trials for MS, and be approved by the FDA, rest assured that Genentech's marketing machine will use every trick in the book to get this newer, less proven, and possibly more dangerous drug given preferential treatment over its low-rent cousin.

Of course, neither of these drugs does one whit to cure MS, but why try to cure something when treating it is so immensely profitable? Rituxan has proven to be quite effective and relatively safe (the PML rate is in the range of 1 in 100,000) when used to treat MS, and the fact that it will never even be given the chance to get FDA approval as an MS therapy simply because its power to generate millions of dollars in profits will soon disappear is nothing short of a travesty, further compounded by the emergence of Ocrelizumab, whose sole reason for existence is to sop up the profits that will be lost when Rituxan goes off patent. Might not the money used to develop and test Ocrelizumab, a figure undoubtedly in the millions of dollars, have been better spent on research that might further our knowledge of how to combat MS, rather than simply finding a way to mimic the actions of an already existing drug in a form conveniently different enough to be patentable (and, apparently, more dangerous)?

Unlike some other MS advocates, who label all of the available mainstream disease modifying drugs nothing more than snake oil, I recognize their value in improving the quality of life of many of the patients taking them. Certainly, even if they do nothing to halt the progression of the disease, dramatically reducing the amount of relapses suffered by RRMS patients has great value, and I know of many patients whose lives have been tremendously improved through the use of today's DMDs. What I can't stomach, though, is the blatant profiteering practiced by the big pharmaceutical companies, as is so clearly illustrated in the Rituxan/Ocrelizumab saga. People's lives are at stake, but I suppose in the world of big money modern medicine that concern pales in comparison with the chase for the almighty dollar.

I say shame on all involved…

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