A Research Revolution

Comment: One way to look for a timely model for medical research on a molecular level would be to find the motion filed in U.S. District (NM) Court of 04/02/01, titled The Solution to the Equation of Schrodinger. It leads to the U.S. copyright TXu1-266-788, which presents the grand unified topological model of the atom as a picoyoctotechnical interactive point map for all particles, fields, and waves.

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I suppose this topic has now gone cold. But for any latecomers (and definitely for Andy Grove himself) you can look at the new article by Paul Albert over on Bacteriality.com:

http://bacteriality.com/2007/12/11/opensource/

I think Paul has a very good point. The 'correct' model for the medical research community to use is not the Semiconductor Industry one, although that was a good first take on the subject -- it is the Open Source Software movement method that should be followed. Paul goes on to give an example of an Open Source Clinical trial as well to prove his point. (The point being that the trial is actually finding cures -- and quickly). If other clinical researchers (especially ones with deep pockets) could take the info and run with it for other illnesses (in parallel with the current ones being worked on) who knows how quickly a lot of them could be also put in the 'cure' bin? There is no reason right now that other researchers in say, MS, or ALS or Alzheimers fields could not also jump on this same bandwagon and attempt similar trials using the same protocol -- they just have not and will not give it a try -- it is hard to turn that giant medical establishment tanker in a new direction very quickly. Sad but true.

sorry:

http://pdpipeline.org

Well here we go again - something pulled because it might work.

It may take some time, but worth reading Grove's speech transcript. Go to www.pdpipeline.org and click on What's New? in left side menu. (grab a cup of coffee)

Maybe he would have. What is it?

deepgroove: Maybe you are right. What is it? Personalized medicine of some type?

Good point except if Andrew did a bit more reading, he would have found that all drug companies are now beginning to use what is called pharmacogenomics to stratify patients into responders and non-responders to get around this problem with averages. Keep in mind that it takes 10-12 years to develop a drug, so those "new" drugs surfacing now are actually based on a decade long science.

Where did all of the comments go, Newsweek, Inc.?

I've worked in the biotech industry for many years, and have always been envious of the pace of change in the IT industry. If every commercially available hardware/software system had to be approved by the FDA and if every hardware/software failure could result in a life-long disability or death, I think that the pace of change in the IT industry would have been much slower. If every new computer system had to be compared to a "gold standard" created in the 1960's (say an IBM 360), I doubt that I'd be having iPhone envy right now. Mr. Grove is absolutely right to challenge the current system for developing drugs, and I hope that he's successful in his push for change. I agree with many of his comments, but the problem is much bigger than the science. It's all of us, and an unwillingness to acknowledge or accept even the lowest levels of risk. Also, molecules aren't discarded, but without patent protection, it's hard to recoup the costs of the clinical trials necessary to get approval of a drug. Thalidomide, the classic teratogen from the 50's and 60's, was approved by the FDA last year for treatment of multiple myeloma, so new life can be given to old molecules.

Mr. Grove - please read about Liatermin / artificial GDNF. The rights are owned by Amgen, and Amgen refuses to use it and refuses to release it to other researchers for further testing on humans.

Amgen won't say why they refuse to release this lifesaving treatment. If they believe it doesn't work - OK - just release it to researchers who want to continue testing and let us resume clinical trials on humans. There will be plenty of volunteers for new clinical trials using Liatermin, I can guarantee that.

Why does Amgen continue to hold onto those patents (and not use the treatment) when Liatermin could save my life and yours, Mr. Grove?

We need answers now. Maybe you can get them.

Let's not heap all the blame on the pharma companies--there's plenty left over for the FDA. The FDA's regulations have created a disincentive for the pharmas to bring a new drug to trial unless they are convinced it will be a winner because it's a REALLY expensive process. And the FDA tells doctors and patients what they may or may not do with a given drug. This nanny-state approach results in a lack of innovation from the companies, and removes the consumer from having any involvement in or input to any part of the drug development process. That being said, another issue is that the pharmas are incentivized to develop only drugs that patients have to take long-term to manage conditions--not to cure them, because then they'd stop taking the drugs. Kudos to Andy Grove for questioning the conventional wisdom and shaking things up!

We people who suffer from Parkinsons are so damn nice. We're plucky and game, charming and self-deprecating; we go on our walks and do our fundraisers. And the biomedical establishment rewards our niceness by smiling and giving us -- what? Another form of L-Dopa? Agonists whose side effects caused Canada to forbid people taking them to drive?

When I was diagnosed at age 47 with Parkinsons, I was told that something new and exciting would most likely be available in 10 years. A few years later, when nothing much had happened, My doctor told me that she was hopeful about something in the works called GDNF.

it's been 10 years and the exciting development is that Amgen has ceased clinical trials of GDNF, refused compassionate use of the drug to patients who put their well being on the line in early studies, and, worst of all, extended its patent on GDNF so that others cannot work with it. Amgen claims to be protecting patients from potentially harmful effects. But the company has yet to provide compelling evidence of these effects. And if GDNF is harmful, and therefore useless, why extend their patent?

Andy Grove is a smart and very tough man. (Read his autobiography!) If he gets mad enough at big pharma, maybe he can take us all with him. We have the numbers. We just need to be willing to get mad, really mad, and not be quite so nice.

We people who suffer from Parkinsons are so damn nice. We're plucky and game, charming and self-deprecating; we go on our walks and do our fundraisers. And the biomedical establishment rewards our niceness by smiling and giving us -- what? Another form of L-Dopa? Agonists whose side effects caused Canada to forbid people taking them to drive?

When I was diagnosed at age 47 with Parkinsons, I was told that something new and exciting would most likely be available in 10 years. A few years later, when nothing much had happened, My doctor told me that she was hopeful about something in the works called GDNF.

it's been 10 years and the exciting development is that Amgen has ceased clinical trials of GDNF, refused compassionate use of the drug to patients who put their well being on the line in early studies, and, worst of all, extended its patent on GDNF so that others cannot work with it. Amgen claims to be protecting patients from potentially harmful effects. But the company has yet to provide compelling evidence of these effects. And if GDNF is harmful, and therefore useless, why extend their patent?

Andy Grove is a smart and very tough man. (Read his autobiography!) If he gets mad enough at big pharma, maybe he can take us all with him. We have the numbers. We just need to be willing to get mad, really mad, and not be quite so nice.

It appears that Andy Grove???s comparison of the technology industry to the drug development process has raised quite a stir, as well as confusion as to what I believe he is really trying to say.
The commonality in the technology industry and the pharmaceutical business is that we are dealing with products that can improve the quality of life for people. However, the very distinct difference is that the consumer has a voice in industrial production; we hear only the company???s voice in the pharmaceutical business. An abrupt cessation of a pharmaceutical product can mean a worsening of a patient???s condition and extreme mental anguish from having put one???s faith in an industry where some companies don???t seriously consider the human element.
How many Edisels did it take for the manufacturer to cease production of that product? Yet, L-dopa (levadopa with carbidopa added as an antiemitic) has been the gold standard of treatment for Parkinson???s for 40 years, in spite of the fact that it doesn???t run as smoothly as a Cadillac. In fact the side effects of this mainstay treatment often results in side effects as bad or worse than the disease itself. Where in corporate America would such a product be allowed to continue to hold its rank?
When Andy Grove says the continued production and forerunner of a product as inferior as the mainstay treatment for a disease that has been around since the 1800???s, I believe he is telling you that this would never fly in corporate America. I believe he is also saying that the pharmaceutical business, unlike corporate America, can exempt itself from many of the rules and regs because of their power structure. In Grove???s approach, there???s no room for juggling statistics or dropping a product if it isn???t going to be a blockbuster. If the drug development process took note of the success of Grove by running a tighter ship of accountability with high expectations,I am convinced we would have better treatments for Parkinson???s. In doing so, we would most likely find the gateway to finding better treatments or maybe even a cure for this and other neurological illnesses.

Considering how many people have Parkinson's, it's incomprehensible that there is no more advance than there has been with finding a cure, or at least new treatments for symptoms. I belong to a website that I hope you would come visit - http://www.patientslikeme.com. You will find me in the Parkinson's section, but there are also communities of ALS, AIDS, and MS patients.

Grove is absolutely talking nonsense. You can't compare an engineering driven product development process where failure means your product is too slow, hot, big, etc. to a science driven process where
product failure means IT DOESN'T WORK! Or worse, your sick patients get sicker. In the semiconductor
market your can quickly measure your results. In the (necessarily) regulated medical marketplace it can
take years to do the same thing.

I think we are missing the point. The point being is that bio-medicine is in "a rut". Why is it that we were better at it before? Why is it that a small biotech company came up with a potential mechanism to treat a specific type of genetic mutation, not a specific disease but a re-usable drug that deals with a genetic mutation type (PTC Pharmaceuticals and it's PTC124 drug candidate currently in Phase III clinical trials). Where are the big pharmas? Why aren't they discovering these drugs?