A Research Revolution

Mr. Grove, I would believe that in your business, as in many other (Pharma included) companies or industries you did/do studies on the strengths and weaknesses of the processes being implemented to reach the ultimate goals. Why doesn't the Parkinson's world put their monies together and hire a think tank, like the Rand Corporation, to find the strengths and weakness of the research being employed to find a cure? Once done, we weed out the weak sticks, put our money on the strengths, and make major steps to FIND THE CURE. There is SO much money going into research without any real accountability, it astounds me that the really bright people haven???t concluded that WE must resolve this, not the Pharmaceutical or other bodies we have looked to and looked at for all these many years. Including you, there are some very bright people with Parkinson???s who have the talent and wherewithal to take on a project like this. What say you?

I think Mr. Grove knows this, but the world needs to know that the Parkinson's world has received old drugs with new names each time a patent expires. Even more interesting perhaps is that the new drugs contain Aspartame, a chemical that ,I think most scientists would agree, should NOT be used in a fragile brain of someone with a neurological disease, much less be used in a healthy person's brain.

Rebecca, e-mail me and I'll see if I can get you in touch with a former MS patient who has successfully used glyconutrients .
bridjta@comcast.net

Thank you, Mr. Grove! We have been waiting to hear from you. Bravo!

Have you heard of Liatermin? In 1994, Amgen bought Synergen Corporation, and with it the patent rights to its synthetic GDNF. It was tested in Phase I and Phase II trials, and trial participants in both the UK and US got their lives back while receiving this treatment. But in 2004, Amgen abruptly halted its Phase II trial and withdrew treatment from participants in all of the study groups.

Since then many of the US trial participants took Amgen to court twice to compel them to provide Liatermin for compassionate use to them (as OK???d by the FDA). Amgen has steadfastly refused, and continues to refuse to sell its patent to other researchers so they can continue trials on humans.

Here is a potential life-saving treatment for Parkinson???s which is being withheld by a single drug company ??? when there are other researchers who would gladly resume testing. This makes no sense ??? either scientifically or financially.

(reposted to get rid of ??? errors)

Mr. Grove questions the pace and goals of discovery and development in biotechnology/pharma, not the mechanisms. He is right in asking what are the reasons and the costs that support the current approach to new drug development. The comparison to the semiconductor industry may be somewhat farfetched but his questions are perfectly valid. I have worked in biomedical research for years, both in academia and in industry, and I know that, unfortunately, research managers have their own agendas. "Not Invented Here" is the rule of the thumb for rejecting new ideas coming from researchers who try to make a difference. Even the entry level scientist firmly believes that he is in competition with the guy at the end of the hallway. Companies will sit on patents and undeveloped products unless their predicted market value is more than USD 300m. Cooperation, which may help achieve breakthroughs, is generally not an option as it would entail sharing potential fame and credit for an achievement and that is generally out of the question.

Mr Grove questions the pace and goals of discovery and development in biotechnology/pharma, not the mechanisms. He is right in asking what are the reasons and the costs that back the current approach to new biomedical therapy development. The comparison to the semiconductor industrry may be somewhat farfetched but his questions are perfectly valid. I have worked in biomedical research for years, both in academia and in industry, and I know that, unfortunatelly, research managers have their own agendas. "Not Invented Here" is the rule of the thumb for rejecting new ideas coming from researchers who try to make a difference. Even the entry level scientist firmly believes that he is in competition with the guy at the end of the corridor. Companies will sit on patents and undeveloped products unless their predicted market value is more than USD 300m. Cooperation, which may help achieve breakthroughs, is generally not an option as it would entail sharing potential fame and credit for an achievement, and _that_ is out of question.

Government regulations and past experiences with medical disaster (see: thalidimide) would seem to be a more pertinent follow-up question. Yes, it's frustrating to consumers to hear about potential breakthroughs in research that never make it in human trials. But wouldn't it be worse to see side effects cause disasters in yourself, your family, or your friends?

I applaud the efforts of Mr. Groves, unfortuantely he's facing a industry completely controlled by big pharma and protected by the government. Advances in medicine are underway all of the time by the physics-minded technology sector.....the problem is that any advancements that do NOT involve big pharma are attacked and/or discredited to protect deep pockets. Americans need to wake up soon...or continue suffering!

I fully appreciate Mr. Grove's position...I only wish more Americans would look into that absolute nonsense that happens to biotechnology companies when attempts are made to advance medicine without the pharmaceutical companies. Nothing short of gestapo tactics are used by the government to control any advancements in medicine that do NOT involve big pharma!. Americans better wake up soon

Mr. Grove needs to read up on the science of complexity. The human body is many orders of magnitude more complex than a transistor, so he's not comparing apples to oranges, but orangutans to oranges! Medicine is so hard to advance because it's so hard to isolate the variables. On top of that there's the placebo effect, which never arises in semiconductor research. The computer industry has relied upon the advances of two devices: the computer chip and the hard drive, and has a very limited number of side effects to protect these devices from, whereas side effects abound in medicine, even in medicines we *think* we understand, such as aspirin. Mr. Grove certainly knows how to build a computer, and I respect his expertise in that area. But until he learns how to build a human--or even a single-celled organism--I won't consider his opinions any more valuable than the man-on-the-street's.

If he wants to complain about anything, he should talk about the slow progress in battery technology. The energy density of batteries has not seen the orders of magnitude increases we've seen in transistors per square millimeter. Electrochemistry is closer to his area of expertise, so he might have something more valuable to say there.

Two points:
1. There is no mechanism in the US for translational research in this country beyond big pharma, which is not willing to risk dollars on unproven technology for diseases that won't guarantee astronomical payouts (like heart disease and diabetes). Therefore, the so-called orphan diseases are solely dependent on philanthropy to take academics' research and try to move it into the clinic..

2. I'm sure people are saying, "But what about the NIH?" NIH funding has remained completely flat for the duration that Bush has been in office, and it is now to the point where we are only funding 9% of the grant applicants, and we are renewing grants at 70% of previous levels. We are failing to nurture an entire generation of young scientists in this country, and they are infrastructure surely as road and bridges are.

In the year and a half since my son has been diganosed with Duchenne Muscular Dystrophy (another disease with a pin-pointed cause and no new treatments in over 20 years), I have been amazed to find out that all of the major breakthroughs are coming from Europe and Asia. My son would have a better chance at early treatment if we were Dutch or British, so those of you who consider the US so superior in all ways should look beyond nuclear stockpiles and flag waving.

"But in pharma, if a clinical trial doesn't work--which means the average of all the patient responses is not better than the average of a placebo treatment--they just throw [the drug] away, when in fact the averages may hide stuff that did work, and something that made patients different [such as genetics]. I've never heard anyone talk about the opportunity costs of a good drug being thrown away. But a good drug wrongfully convicted means the loss of benefits goes on forever."

....yes Mr. Grove, and that is exactly what has happened to a generation of Parkinson patients. Good Drug No Future ......

Bravo, Andy!! Not one new drug since my wife was diagnosed 10 years ago, only reformulations of the old ones. Big pharma won't change unless they see patent and profit potential which is tempered by the FDA's arcane rules and regulations.

Mr Grove shows the same misunderstanding of science that Bill Joy did when he suggested that science research into nanotechnology should end until it can be regulated. Comparing pharma with Intel is to compare science with engineering -- the two are truly incomparable.

Science begins with an immeasurably complex black box which must be slowly and carefully dissected before it can be understood. Pharma can't wait to do that, so it has to literally shoot in the dark to try to fix what *might* be broken. The microelectronic industry works with a white box in which *everything* is known about the device. As such, it's easy to make small changes will complete certainty as to the outcome.

Also pharma has to experiment on mice/rats/dogs/monkeys because they lack simulators on which they can test their ideas. Pharma experiments often take months/years vs the minutes/hours that Intel enjoys. And unfortunately, most of the time the drug's target mechanism is different in animals than in man, making the experiments prone to misinterpretation and complication.

Engineering may be hard, but science is nearly impossible.

No, Grove is right. There can be commonality in the biomedical industry that could be reused. The mechanisms of diseases are quite common, especially genetic disorders. You have X types of mutations. Where they lie determines the disease. The biomedical industry has the ability to piece this together. They have done so with rodents rather well. What is missing and has been missing for years is translational research. Taking the discoveries from mice to men. This was and still is a rather big gap. The NIH is doing what it can to close this gap but big pharmas need to get involved if we want to see any major progress in closing this gap. They are just not willing to risk the money. It is easier to tweak an existing drug and get a new patent.

"something that made patients different [such as genetics"

Uh, andrew, everyone is exactly the same.

Grove cannot compare the pharmaceutical industry with the electronics industry - at least not rightly so. The growth in the electronics industry is due to the advances in transistors. Really it is these transistors that underlie the whole industry. Using the learning effect theory, these are going to become easier and easier to produce the more of them that are produced. Think about how many billions of transistors are produced - no wonder they keep getting smaller and allowing such advances in electronics.

Compare this to the pharmaceutical industry. Research is done on an individual basis for each disease. A cure is not a simple transistor, but rather, it is based on a complex problem. It takes time to discover all the interactions between complex drugs and the complex human body.

Maybe there are problems with the pharmaceutical companies, but in a very basic sense, these two industries cannot be compared. This criticism, coming from a CEO of one of the most respected companies, is something that any undergraduate studying Operations Management can tell you is wrong.

This cannot be discussed with no mention of the legal climate around the medical industry. "The fundamental tenet that drives us all in the semiconductor industry is a deeply felt conviction that what matters is time to market, or time to money." I can just see Dr. Grove being bashed over the head with that comment in a court room or by a grandstanding politician in some ridiculous congressional hearing. Intel has had its share of courtroom battles over the years, but nothing that comes close to what pharmaceutical companies face. He makes very good points, and I tend to agree with him, but the two operating environments are radically different.

hello Dear Mr. Grove,
If we were machines - I have confidence that your corporation would have fixed us all by now...
I am an advocate for cures -
I was diagnosed in 1994 at age 31,
They have two extremely good alternatives to palliative meds - since L-Dopa Carbi-dopa - are certainly not cures at all...
Amgen had GDNF -they withdrew the drugs from the patient study,
by pulling a monkey out of their (back pockets) -I do know the men were getting out of their wheel chairs -
the study was done by the Morris K. Ufdall -doctors/ scientists at the University of Kentucky.
the similiar study in Bristol England had excellent findings the GDNF protein worked!
Dr. Michael Levesque at Cedar Sinai in LA, had great success with an adult stem cell transplant,and testified before congress - but the good doctor has not been approved for clinical trials - I know you are a man with a good mind for good business,
but bigpharma only thinks good business works with addictive /palliative drugs - Mirapex was not a good drug for many PD patients, but they aren't interested in patients being cured, just the dividends of big money being added to there bank accounts.
peace to your heart,
sincerely,
christena