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They are talking about "blockbusters" for MS over the next 10 years. I think that means a drug with over US$ 1 billion in annual revenues. They may be right that there aren't any on the horizon for MS, but I don't think it's correct that there won't be any new drugs in the next 10 years which are far more effective than anything we have today, including Tysabri.



FDA's Likely Approval to Relaunch Tysabri, Despite Rare Fatal Side Effects, Demonstrates Significant Need for Effective Treatments Against Multiple Sclerosis

Despite Active Pipeline, No Blockbuster Drugs Expected to Emerge in Next Decade, According to a New Study from Decision Resources

May 02, 2006 - PRNewswire - Decision Resources, Inc., one of the world's leading research and advisory firms focusing on pharmaceutical and health care issues, finds that the likely reintroduction of Biogen Idec/Elan's Tysabri (natalizumab) in the United States, despite rare fatal side effects, is a testimony to the high unmet need for efficacious treatments against multiple sclerosis (MS).

The new Pharmacor report entitled Multiple Sclerosis finds that a recent recommendation by a U.S. Food and Drug Administration (FDA) advisory panel to relaunch Tysabri will result in the return of the drug to the U.S. market this summer and its launch in Europe by the end of 2006. Tysabri was voluntarily pulled from shelves by Biogen Idec/Elan earlier this year following rare fatal cases of progressive multifocal encephalopathy. The report also finds that, although the pipeline to treat MS is remarkably active, no blockbuster drugs are expected to emerge in the market through 2015.

"Although Tysabri will be a player in the market following its relaunch because of its significant efficacy, neurologists say they are uncomfortable administering this drug as a first-line therapy in light of the potentially fatal side-effects," said Andrea Witt, Ph.D., analyst at Decision Resources, Inc. "One physician indicated that he would prescribe Tysabri only to a patient in 'desperate straits' because of the risks associated with the drug. Based on these factors and other key findings, we forecast that neither Tysabri nor any emerging drug in the dynamic MS pipeline will become blockbusters in the next ten years."

http://www.pharmalive.com/News/index.cf ... egoryid=10

The article underscores the general mindset of the pharmaceutical industry, which is all about sales and not much else. Either a drug has to generate revenue by being incredibly expensive on a per person basis, or there has to be a lot of people with the disease being treated. MS of course is in the first category - there are just not enough people with MS to be profitable for a drug company unless we all fork out 20+K a head for a drug per year.

My gut feeling is that Tysabri utilization is going to be limited, as indicated in the article. I think a lot of doctors now will only be willing to prescribe it in people with more severe symptoms, and perhaps those people will have to demonstrate lack of response on the CRABs first. The only thing that will make Tysabri take off is if the people on it demonstrate clear and sustained benefit and the severe side effects remain low - to build the benefit and safety profile will take several years. At least it will be an option and I hope that benefit will come from it.

My big immediate frustration is that I believe a lot of people could get as good or even better response with existing drugs on the market, antibiotics and others - if they would just run the clinical trials to prove it. I wish, failing a full clinical trial on these, that there would be a consortium of physicians who are treating patients with existing drugs that at least could publish some rigorous case series reports and get observations out in the medical literature. I also wish for a large, systematic study of MS patients using the latest technology in looking for biochemical abnormalities and inborn errors of metabolism to help uncover the cause of MS. I do not see in the literature where such research has ever been done. Those are my near-term wishes.

Lisa

Lisa

Like most people, I'm sure, I would like the drug companies to have great humanitarian purposes behind their action. But Lisa and most of us know the real motive.

There are so many good ideas in the book recommended by NHE, Overdo$ed America by John Abramson, M.D., that I must quote one more here: "The drug companies have no more responsibility to oversee the public's health than the fast-food industry has to oversee the public's diet." (page 243)

This may not be the way we want it in an ideal world; but this is the way it is. As many have said, the efforts should be toward finding THE CAUSE of MS. It simply seems to be the logical starting point to me. But who has a real reason to do such basic, unbiased research? Thanks for letting me air my humble opinion.

I read an article in USAToday on a seemingly unrelated topic to MS - the emergence of antibiotic-resistant illnesses, encountered not only in hospital settings, but out in the general public, often affecting people that appeared to be healthy. The article basically states that little to no research is being done to develop new antibiotics in spite of this emergence of super-bugs, because (here comes the clincher) the pharmaceutical industry is generally not interested in developing curative medications administered over a period of days, but rather medications that must be administered chronically over a lifetime, because they must deliver profits to their shareholders. This "chronicity element" adds another dimension to my earlier post regarding numbers of people with the disease.

How this relates to drug development for MS and a multitude of other chronic diseases is obvious, and the implication is huge for the entire planet, not just people with MS. There is something very wrong with the big pharma system if the USA Today statement is correct (maybe it isn't). I'm in a very cynical mood at the moment, but am hard-pressed to think of any major, curative breakthrough drug that has emerged in recent years for much of anything. It seems that most of the major medical breakthroughs for treatment have actually been on the surgical side of the equation - that is, pioneering surgeons that have been primarily supported with advances in imaging technology, surgical tools, and computerization. Surgical developments probably did not develop from consortiums. I'm not a surgeon and don't know one, but I suspect they do a lot of hands-on training and info-swapping and don't limit their vision by what is most profitable. Other, nonsurgical breakthroughs have been finally figuring the CAUSE of a chronic illness (think Helicobacter and stomach ulcers).

To be fair, there have been new generations of drugs developed, but they all seem to be tweaked versions of stuff that has been out decades ago - I think of antipsychotics, insulin, and basic classes of antibiotics for example. I guess there has been advances in chemo treatments for some childhood blood cancers and breast cancer. For some limited antivirals, we largely have AIDS to thank - AIDS pushed a lot of research in the immune system - my immunology textbooks from the 1980s might as well have been written 100 years ago, the field exploded that much. As an aside, I wonder how much of the AIDS research was privately vs publicly funded.

In short, something seems very wrong to me - not just regarding the state of pharmaceutically-related MS research, but the state of pharma research in general. Maybe I'm just in a bad mood and totally wrong, and I don't mean this post to be a drug company bashing exercise. I hope for some thoughts and ideas. Anybody?

Lisa

As Chris Rock says, there is no money in curing illness, but millions to be made in treating illness. Our current Pharma industry is rotten to the core. As you noted, what diseases have been cured in the last twenty years?

If Governments took a more active role in research, we might see better results. Left to the free market system, we will continue to see development of obscenely expensive drugs designed to treat, not cure, illness...

I saw another potentially perturbing article on the BBC website today regarding alternative remedies and NHS funding.

http://news.bbc.co.uk/2/hi/health/5007118.stm

I'm in the U.S., so this doesn't affect me directly, but I am concerned about it. I am a supporter of evidence-based medicine for its scientific rigor, BUT, and this is a big BUT - I am concerned that potential remedies will never get the opportunity to even be tested if there is no interest in funding their trial, and if private pharmaceutical funding becomes the only source of research. I don't know how things are in Europe and elsewhere, but I get the sense that public funding for research is fast dwindling in the U.S.

On the American side of the pond, there have been a recent slate of articles indicating that access to vitamins and nutritional supplements be curtailed, because most people who take them are already healthy and "don't need them", etc. I am not sure that I believe this, either. I've seen a lot of convincing animal studies coupled with some human case reports and case series studies indexed on PubMed showing promise for treatments mitigating the course of a disease or injury. Unfortunately, a lot of these substances won't make it to a full clinical trial because they are an older, unprofitable drug or a nutritional supplement.

For individuals with conditions for which there is no good, reliably effective "evidence-based" treatment, I would hate to see all "alternative" avenues cut off, which could happen through a variety of mechanisms - pulling all nonpresription access to vitamins, and for presciption medications, limiting insurance coverage for any "off label" applications. This will greatly limit options for both practicing physicians and their patients.

In a more perfect scientific, evidence-based world, we would see promising treatments move quickly to full clinical trials based on the potential for efficacy and safety, rather than the race to make the biggest profit by cornering the market share. And I'm afraid it's the latter that drives the source for what studies will be considered evidence-based.

Lisa