A Research Revolution

Mr. Grove knows what he is talking about. The Parkinson's community is just waking up to the fact that throwing money at research will not find a cure for this debilitating disease. More effort needs to be applied on bringing forth the discoveries made in the labs to treatments for patients.
Brought together by the Internet, patients now can keep track of the progress of research. We can access the journals. We can communicate with researchers across the world. We know what the pharma companies are doing and we know that for many of them -- the bottom line is what really matters.
There was an effective treatment for Parkinson's being developed. It is called GDNF -glial cell line derived neurotrophic factor. Delivered by a pump infusion method directly into the brain it gave many clinical trial participants in the US and the UK their lives back. Three years ago, Amgen, the patent owner and sponsor of the phase II trial pulled the plug on further human testing and denied compassionate use (which was okayed by the FDA) for those who were already receiving treatment in the clinical trials. The results of their phase II trial are considered by many scientists as inconclusive due to differences in dosage and delivery system from the phase I trial. Further research was recommended.
Many patients believe that GDNF works, and it was the most hopeful treatment under development for those in advance stages. There is nothing else comparable available now.
Amgen hasn't continued the development of this treatment and wouldn't sell it to another company or researchers who are very interested in it. What an awful waste!

There is a small revolution starting in medicine already, and from a contributor who was also part of building the technology industry. Some of those same open-source concepts have been ported into solutions for diseases of aging and chronic inflammatory diseases now also clearly associated with cancers.

Unfortunately, status quo medical industry brick, mortar, and government regulation has stalled progress already revealed by molecular genomics and a ground-breaking pathogenesis. It is not researchers or their industry that should shoulder all the blame, but we ourselves for not demanding congressional acts that remove the barriers and pave the way for results with humans, in silico and in vivo, with full comprehension of the human immune system genomics and metagenomics. We, as an aging population (and we are all aging every day no matter how old we think we are), must demand and expect this new science to come to light now.

It will require legislation to move genomic clarity from sitting idly in regulation files because it is not yet recognized as evidence that surpasses failed but legally-approved murine models. The NIH and FDA might think to move slowly forward into the science of this century but instead strangles and stalls, full of rank and corps who must service the revolving door with personally safe but socially cancerous lack of action that hide blissfully behind a lack of demanding legislation to move them into this century.

We are all so familiar with the death sentence we see about us, we actually believe there is nothing that can be done so we let distractions of war and getting on with our daily lives stop us from the future we should bring. I'm with Andy in thought and purpose. I am recovering from a killer disease. Are you?

There is a small revolution starting in medicine already, and from a contributor who was also part of building the technology industry. Some of those same open-source concepts have been ported into solutions for diseases of aging and chronic inflammatory diseases now also clearly associated with cancers.

Unfortunately, status quo medical industry brick, mortar, and government regulation has stalled progress already revealed by molecular genomics and a ground-breaking pathogenesis. It is not researchers or their industry that should shoulder all the blame, but we ourselves for not demanding congressional acts that remove the barriers and pave the way for results with humans, in silico and in vivo, with full comprehension of the human immune system genomics and metagenomics. We, as an aging population (and we are all aging every day no matter how old we think we are), must demand and expect this new science to come to light now.

It will require legislation to move genomic clarity from sitting idly in regulation files because it is not yet recognized as evidence that surpasses failed but legally-approved murine models. The NIH and FDA might think to move slowly forward into the science of this century but instead strangles and stalls, full of rank and corps who must service the revolving door with personally safe but socially cancerous lack of action that hide blissfully behind a lack of demanding legislation to move them into this century.

We are all so familiar with the death sentence we see about us, we actually believe there is nothing that can be done so we let distractions of war and getting on with our daily lives stop us from the future we should bring. I'm with Andy in thought and purpose. I am recovering from a killer disease. Are you?

hello I was diagnosed in 1994 at age 31 and there was a chance of a cure, GDNF owned by Amgen but it worked too well, so they pulled a BS monkey studyout of their back pockets, their is also available Dr. Levesques adult stem cell operation - so far they have given us bad drugs such as the likes of Mirapex, with
horrid side effects -they could cure us, but palliative medicine is their bread and butter ...
if bigpharma had it their way we'd all be on drugs! yet these drugs do not cure -they are only palliative at best.
sincerely,
a young onset pissed off parkie...

While I understand Mr. Grove's example of comparing drug development to the management of his life-changing computer chip development, a different perspective can also be presented when comparing the two. Information at peoples' fingertips, with the help of Intel, has resulted in it becoming almost dynamic. By the time a drug is developed. something else is learned, something better is presented. The treatment or the delivery method is obsolete before it gets to market, just like Ipods, cell phones, or technology in general, are always being 'improved'. This can be good in some cases; not good in others.

I like ducks though.

" People in labs trying to save the world, have barely interacted with a patient who has the disease they are trying to solve. Doctors, I mean specialists, are part of a team. How can we get them to realize this? They think they are superior. And pharmas, biotechs etc. wouldn't save their own family members if it wasn't economically profitable," she quacked.

Research cultural revolution. Do it or die.

Andy should try his hand at science sometime. It is disingenuous to compare the peer review system to medieval guilds. Maybe its the Parkinson's...

How quickly would Intel advance if there were hordes of lawyers waiting to pounce with class action suits over the FDIV bug, or if it could be driven into bankruptcy over non-factual claims about their products?

Earth to Mr. Grove: alas, science doesn't work like a corporation. Nature is sadly resistant to executive or Congressional Congressional decree.

The premise of the article is flawed, as is Mr. Groves understanding of drug development. I also believe Mr. Groves opinion is being colored by his condition; being effected by a greivous illness. If I had parkinsons, I would want to know when I could expect a treatment as much as Mr. Groves does.

The nature of drug discovery is much different than the nature of developing consumer products. Defective Intel processors irritate customers, and can even cost customers money and cause recalls (remember the FPU math fault in the original Pentium processor) . Defective drugs kill people - there is no recall for that. Drugs that fail in trials do not just get shelved. The drugs which fail trials are examined for use in other indications, or the science around the drug is expanded and new compounds are developed that may be more efficacious. Failed drugs are also sold to other companies that may see promise in them or alternative use.

A pharma executive can not tell if a drug will be safe and efficacious, that answer is in the hands of science or God - depending upon your persuasion. Any pharma executive that would step forward saying "by date x, our company will have developed, tested and marketed a drug to treat or cure condition y" would be a charlatan.

The premise of the article is flawed, as is Mr. Groves understanding of drug development. I also believe Mr. Groves opinion is being colored by his condition; being effected by a greivous illness. If I had parkinsons, I would want to know when I could expect a treatment as much as Mr. Groves does.

The nature of drug discovery is much different than the nature of developing consumer products. Defective Intel processors irritate customers, and can even cost customers money and cause recalls (remember the FPU math fault in the original Pentium processor) . Defective drugs kill people - there is no recall for that. Drugs that fail in trials do not just get shelved. The drugs which fail trials are examined for use in other indications, or the science around the drug is expanded and new compounds are developed that may be more efficacious. Failed drugs are also sold to other companies that may see promise in them or alternative use.

A pharma executive can not tell if a drug will be safe and efficacious, that answer is in the hands of science or God - depending upon your persuasion. Any pharma executive that would step forward saying "by date x, our company will have developed, tested and marketed a drug to treat or cure condition y" would be a charlatan.

The premise of the article is flawed, as is Mr. Groves understanding of drug development. I also believe Mr. Groves opinion is being colored by his condition; being effected by a greivous illness. If I had parkinsons, I would want to know when I could expect a treatment as much as Mr. Groves does.

The nature of drug discovery is much different than the nature of developing consumer products. Defective Intel processors irritate customers, and can even cost customers money and cause recalls (remember the FPU math fault in the original Pentium processor) . Defective drugs kill people - there is no recall for that. Drugs that fail in trials do not just get shelved. The drugs which fail trials are examined for use in other indications, or the science around the drug is expanded and new compounds are developed that may be more efficacious. Failed drugs are also sold to other companies that may see promise in them or alternative use.

A pharma executive can not tell if a drug will be safe and efficacious, that answer is in the hands of science or God - depending upon your persuasion. Any pharma executive that would step forward saying "by date x, our company will have developed, tested and marketed a drug to treat or cure condition y" would be a charlatan.

I do not believe timetables can be expected in the pharmaceutical industry, a medical product undergoes several processes which are not even part of the production phase, they are in fact part of the "invention" of the product. Maybe it is in fact important to support research and innovative techniques in order to achieve faster ways of health for the constant issues concerning human/animal wellbeing, and yes it is rather difficult to think how Parkinson disease's meds have not changed at all but perhaps it is due to the fact nothing better has come up yet. I think that it's way better to wait for a proper-engineered product than a fast-new-product which may be displaced in a couple of years by something with a better quality and manufacturing process.

Denisse E.

Why is the speed of progress so different in semiconductor research and drug development? Simple, drug hunters cant put out drugs that will kill their customers. Atleast they try their best not too. And who are you goint to test drugs that have hidden liabilities if not on rodents and non human primates? That takes time.
For example, how do you treat a disease like Alzheimer's that in a majority of the population takes 50 and more years to manifest itself? Ofcourse companies and scientists want to cure diseases. Its just not as easy or simple as Andrew Grove and others who have never attempted to cure a disease make it sound. Drug discovery is the most frustrating and hardest pursuits out their. ~s

Thank you Andy Grove - I couldn't agree with you more about the ducks. This research team works on this; that team works on that - but they don't talk or connect the dots enough. Some of the loudest quacking is coming from knowledgeable patients on the internet. Researchers should work on the cutting edge, but when they pass up treatments for shinier new technology., people die.

Paula

Of course there's something wrong with big pharma! The FDA and the pharmaceutical industry want to make sure nothing that works outside of their realm is ever used. Why? Because it would cut into their profits. This industry is about making money. Period. I personally don't use Western medicine unless there is no other option. Too many people believe "alternative" medicine is risky and ineffective. Truth is, the real risk is in drug therapies and the belief the way to stifle disease is to stop the symptoms, without regard to what is causing the symptoms. A classic example is cholesterol. Doctors want to lower it with drugs and with no regard to why it's elevated. That's as crazy as unplugging the pesky oil light in your car. As a Registered Nurse (for over 35 years, most of it in critical care units), I'm disgusted with what passes for "science". Newtonian physics has been old hat for centuries. It's time to step into Quantum physics and really learn something awesome.

yes, we do need a revolution in biotech, it needs to be like the rvolution that gave us the personal computer revolution that produced bill gates and steve jobs, they got us away from the "elites" that ran the big mainframe computers of that long-gone era and now we have the internet and cheap, powerful computers in just about every aspect of our lives. Did you know that before the human geneome project, that there were biologists that could not possibly see a reason to decode all the genes in humans and animals? What we need is a massive project, based on the principals of the current open-source computer software revolution (linux operating system) where medical knowledge is not owned by big publishers like Nature magazine and also the big phama companies, we need open source projects like MIT's biobricks where even high-school kids can design and assemble new biological parts like the computer nerds built their computers that launched the personal computer revolution and companies like novel, microsoft, intel, apple etc.
The computerization of biotech (called bioinformatics) is allready changing biology and also tying it to the phemonimal growth of computer tech (moors law), where soon, you could get your genes sequenced at your doctors office to beeter diognose your ills and personalize any medical treatmen needed. In the UK, they are funding the next step in nanotech research where the next generation of nano-engineers will use computers to design small nano-computers attached to small robotic nanoassemblers and be able to eventually do all storts of things like monitor cellular functions, diagnose deseases, fix cellular functions bakc to naormal, eliminate all deseases, make people young again..the sky is the limit, 150 years ago, the car, phone, televistion, computers, the internet, the moon shot were not even possible to properly imagine or even possible to plan for, now we are on the brink of the biotech/computerized nanotech revolution and this is a direct result of the chip revoution, the computer revolution that gave us peaple who could build computer chips with 10 billion (nano-sized transistor) components, program these systems with millions of lines of complex computer code, now we have the nano-tools to address the complexiity of the human body and its 3 billion codes of DNA and will soon ahve the capacity to understand how its components work, how to custom build its parts and replacement DNA parts, how to mod it, how to repair ist DNA parts indefinely etc, we will have come out of our current medical "dark ages" into a more rational age. Did you know that the Mprize is a prize for researchers to slow/stop/reverse aging in mice, then huamans (www.mprize.org), this is an example of the new thinking and how ordinairy people can contribute their ideas, monies etc towwards these goals.

Andrew Grove is right. There is something fundamentally wrong with the pharmaceutical industry. It is costing most stakeholders dearly. To illustrate, within about the last couple of years the pharmaceutical industry has thrown out Vioxx (Merck, pain), Bextra (Pfizer, pain) and torcetrapib (Pfizer, in late stage development for cholesterol management) because of increased risk for heart attack, stroke and death. These three examples alone cost tens of billions of dollars in lost development costs, lost sales opportunities and legal liability. In all three examples, the increased risk appears to have been mediated at least in part by increased blood pressure. Increased blood pressure is one of the most widely known risk factors for heart attack, stroke and death. Furthermore, blood pressure typically is measured when patients visit doctors ??? perhaps especially when patients participate in randomized clinical trials (RCTs). Given these conditions, how could the FDA and the industry inadequately account for the effects of increased blood pressure?
Part of the reason is that first generation RCT designs that are taught by universities, enforced by the FDA and followed by industry do not measure and test the benefit/harm of treatment with respect to health variables. Benefit/harm can be measured over time and across health variables starting at the level of individual patients. Instead, researchers perform statistical tests on health variables or changes in health variables and assess causality by using group comparisons. It is possible to measure and test benefit/harm when drugs are used to manage and control chronic functional health problems, which generally are recognized to consume over 75% of our health care dollars. This includes Parkinson???s disease ??? a problem apparently of some personal interest to Andrew Grove.
Here is another way to describe the problem with first generation RCT designs. They confound or mix up individuality with measurement error, dose with type of treatment, and treatment effects with how they are valued. Such confounding largely precludes personalized health care and drastically weakens the evidentiary basis for many decisions involving health care.
A software solution to these problems has been publicly available since at least 1992. However, this technology is disruptive. The heavily regulated pharmaceutical industry is highly resistant to disruptive innovation that involves RCT design.
This software is compute intensive. Helping to fix the pharmaceutical industry is a huge market opportunity for Intel and other information technology companies.

Andrew Grove is right. There is something fundamentally wrong with the pharmaceutical industry. It is costing most stakeholders dearly. To illustrate, within about the last couple of years the pharmaceutical industry has thrown out Vioxx (Merck, pain), Bextra (Pfizer, pain) and torcetrapib (Pfizer, in late stage development for cholesterol management) because of increased risk for heart attack, stroke and death. These three examples alone cost tens of billions of dollars in lost development costs, lost sales opportunities and legal liability. In all three examples, the increased risk appears to have been mediated at least in part by increased blood pressure. Increased blood pressure is one of the most widely known risk factors for heart attack, stroke and death. Furthermore, blood pressure typically is measured when patients visit doctors ??? perhaps especially when patients participate in randomized clinical trials (RCTs). Given these conditions, how could the FDA and the industry inadequately account for the effects of increased blood pressure?
Part of the reason is that first generation RCT designs that are taught by universities, enforced by the FDA and followed by industry do not measure and test the benefit/harm of treatment with respect to health variables. Benefit/harm can be measured over time and across health variables starting at the level of individual patients. Instead, researchers perform statistical tests on health variables or changes in health variables and assess causality by using group comparisons. It is possible to measure and test benefit/harm when drugs are used to manage and control chronic functional health problems, which generally are recognized to consume over 75% of our health care dollars. This includes Parkinson???s disease ??? a problem apparently of some personal interest to Andrew Grove.
Here is another way to describe the problem with first generation RCT designs. They confound or mix up individuality with measurement error, dose with type of treatment, and treatment effects with how they are valued. Such confounding largely precludes personalized health care and drastically weakens the evidentiary basis for many decisions involving health care.
A software solution to these problems has been publicly available since at least 1992. However, this technology is disruptive. The heavily regulated pharmaceutical industry is highly resistant to disruptive innovation that involves RCT design.
This software is compute intensive. Helping to fix the pharmaceutical industry is a huge market opportunity for Intel and other information technology companies.

You cannot compare the computer industry and the way things get to the market with the pharma industry. Playing with electronics is not the same thing as playing with people's lives. Most of the time it takes more than a decade for a single drug to even get to the clinical stage and then there is no guarantee that the drug will not fail. Fruthermore, research is driven by demand. Right now a lot of focus is being diverted to treating obesity releated illness because of the high demand. Maybe if people would take some of the responsibility then the researchers could focus on more important things. Moreover, if illness A only affects 1 out of 100 people and illness B affect 50 out of 100 people then of course there will be a greater research effort for illness B. Drug development is expensive and we are doing the best that we can with the resources that we have. By the way, academic research is necessary to drive the future because that is where the creativity lies.