A Research Revolution

One significant barrier to more rapid progress in pharmaceutical research is the litigious nature of the American healthcare system. Even established drugs, with known side effect profiles, are subject to massive suits and withdrawals if these side effects actually occur. Each and every drug potentially brought to the market needs to be evaluated not only for efficacy and safety but for the likelihood of being the subject of a capricious lawsuit designed not to protect consumers but to encourage settlements which enrich only the attorneys taking the cases.

Two societal barriers stand in the way of patient-genetics-specific pharma testing:
1. Scientific acknowledgement of the requisite differentiations leads in socially controversial group vs. group directions, i.e. if my forebrain neurochemistry is different from yours, what happens if the stepwise-next scientific conclusion is that my ancestral group is inferior to your ancestral group in intelligence, or superior in physical abilities?
2. Similarly, if anti-Alzheimers pharmaceutical X works on you but not on me, does that make you life-insurable until age 90, and me only until age 50? How about my ability to practice my profession? Suppose it's an anti-heart-attack drug...how about employment, or my driver's license?
It's not sufficient to call for changes without effectively addressing the sensitive barriers...and not by just wishing them away, or dismissing those who regard them as important.

Two societal barriers stand in the way of patient-genetics-specific pharma testing:
1. Scientific acknowledgement of the requisite differentiations leads in socially controversial group vs. group directions, i.e. if my forebrain neurochemistry is different from yours, what happens if the stepwise-next scientific conclusion is that my ancestral group is inferior to your ancestral group in intelligence, or superior in physical abilities?
2. Similarly, if anti-Alzheimers pharmaceutical X works on you but not on me, does that make you life-insurable until age 90, and me only until age 50? How about my ability to practice my profession? Suppose it's an anti-heart-attack drug...how about employment, or my driver's license?
It's not sufficient to call for changes without effectively addressing the sensitive barriers...and not by just wishing them away, or dismissing those who regard them as important.

I believe Mr Grove's comments are particularly insightful and need to be taken seriously. I believe his emphasis is on reform of the development process. If a drug fails, no efforts are undertaken to understand why the drug failed and valuable inductive information is lost. He knows what he's talking about -- if the electronics industry used the same processes the pharma industry uses, we'd still be using vacuum tubes.

This is a classic managerial attitude coming from someone who, I assume from his comments, has little practical knowledge of how drugs affect a system as complex as the human body. One protein involved in the onset of cancer, may also have a critical role in the growth and replication of cells as well as tens of other interactions in various other molecular pathways. Targeting that one protein may be a solution, but in the non-cancerous cells that surround it and somatic cells in general it may create havoc when necessary functions are shut down as a result. In addition, finding a novel solution can be quickly abrogated by redundancies in the body which resumes the negative function while making the novel solution obsolete. Iressa (Gefitinib) is one drug in particular that was very effective as a breast cancer treatment until people developed a resistance to it by using another pathway to perform the same function. Research is currently underway to understand WHY this happened the way it did. Comments like his may sound great, but in practical application there is little benefit and much to lose. There is something to be said about letting the ???wild ducks quack??? . Looking into the past, great scientific achievements have come from allowing passionate scientists. Frederick Sanger, a scientist working at Cambridge was literally kicked out of his lab after what the university considered years of fruitless research. He moved his lab into a hallway and continued his work. Dr. Sanger was eventually awarded TWO Nobel prizes for his work-- one for sequencing and determining the structure of insulin and the other for helping to invent a way of sequencing DNA. This research jumpstarted the genomic and proteomic research we enjoy today. While cures aren???t fast or easy to come by, it is due to the dedicated work of scientists who devote their lives to improving the plight of man.

Grove displays an incredibly shallow knowledge of drug discovery and development and the many important differences between biological science and chip engineering. While making a new chip involves building on many incremental advances and solving new ones. Developing a drug is 10% engineering (choosing well a potential drug molecule) and then 90% unveiling how it works in people - an unbelievably complicated biological system. In most cases the drug doesn't work and you lose your investment, often having to start anew. Setting goals like "xyz drug this year" is fantasy.

Grove displays an incredibly shallow knowledge of drug discovery and development and the many important differences between biological science and chip engineering. While making a new chip is building on many incremental advances and solving new ones. Developing a drug is 10% engineering (choosing well a potential drug molecule) and then 90% unveiling how it works in people - an unbelievably complicated biological system. In most cases the drug doesn't work and you lose your investment, often having to start anew. Setting goals like "xyz drug this year" is fantasy.

This is a classic managerial attitude coming from someone who, I assume from his comments, has little practical knowledge of how drugs affect a system as complex as the human body. One protein involved in the onset of cancer, may also have a critical role in the growth and replication of cells as well as tens of other interactions in various other molecular pathways. Targeting that one protein may be a solution, but in the non-cancerous cells that surround it and somatic cells in general it may create havoc when necessary functions are shut down as a result. In addition, finding a novel solution can be quickly abrogated by redundancies in the body which resumes the negative function while making the novel solution obsolete. Iressa (Gefitinib) is one drug in particular that was very effective as a breast cancer treatment until people developed a resistance to it by using another pathway to perform the same function. Research is currently underway to understand WHY this happened the way it did. Comments like his may sound great, but in practical application there is little benefit and much to lose. There is something to be said about letting the ???wild ducks quack??? . Looking into the past, great scientific achievements have come from allowing passionate scientists. Frederick Sanger, a scientist working at Cambridge was literally kicked out of his lab after what the university considered years of fruitless research. He moved his lab into a hallway and continued his work. Dr. Sanger was eventually awarded TWO Nobel prizes for his work-- one for sequencing and determining the structure of insulin and the other for helping to invent a way of sequencing DNA. This research jumpstarted the genomic and proteomic research we enjoy today. While cures aren???t fast or easy to come by, it is due to the dedicated work of scientists who devote their lives to improving the plight of man.

This is a classic managerial attitude coming from someone who, I assume from his comments, has little practical knowledge of how drugs affect a system as complex as the human body. One protein involved in the onset of cancer, may also have a critical role in the growth and replication of cells as well as tens of other interactions in various other molecular pathways. Targeting that one protein may be a solution, but in the non-cancerous cells that surround it and somatic cells in general it may create havoc when necessary functions are shut down as a result. In addition, finding a novel solution can be quickly abrogated by redundancies in the body which resumes the negative function while making the novel solution obsolete. Iressa (Gefitinib) is one drug in particular that was very effective as a breast cancer treatment until people developed a resistance to it by using another pathway to perform the same function. Research is currently underway to understand WHY this happened the way it did. Comments like his may sound great, but in practical application there is little benefit and much to lose. There is something to be said about letting the ???wild ducks quack??? . Looking into the past, great scientific achievements have come from allowing passionate scientists. Frederick Sanger, a scientist working at Cambridge was literally kicked out of his lab after what the university considered years of fruitless research. He moved his lab into a hallway and continued his work. Dr. Sanger was eventually awarded TWO Nobel prizes for his work-- one for sequencing and determining the structure of insulin and the other for helping to invent a way of sequencing DNA. This research jumpstarted the genomic and proteomic research we enjoy today. While cures aren???t fast or easy to come by, it is due to the dedicated work of scientists who devote their lives to improving the plight of man.

I find Grove's position to be naive and ill informed. There are huge, vast, differences between how a drug is developed and how an electronic device is developed. While there is much known about how to design and fabricate chips and improve them in that way, there is much about biology still to be learned and much to be done to understand how best to treat an illness. Hence the need for these so-called pointless animal experiments that don't lead anywhere. What would Grove prefer -- to test things in humans right away and see how they work? It's not like a piece of electronic equipment - if it fails, you throw it away. If a drug fails in any one of a million ways that drugs could possibly fail, people die. Pharmaceutical science needs to be driven by scientists, not by wannabes who are frustrated by the pace. The cost is much too high.

As a "patient" with several labels from the medical community AND a member of the medical community, I feel the frustration from both sides. I've been involved in clinical studies as a health care provider and have seen the bureaucratic bologna that happens. There are several phases to clinical trials, and when we get to the point of testing on people, well how many people are raising their hands? Some of us may say, "I would do it!!", but there is a lot of risk for both medical community and pharmaceutical trial participant. What about medications and pregnant women? Doctors don't know what they can given pregnant women b/c the FDA won't approve testing on pregnant women b/c of the theoretical risk to the fetus. That's a no-brainer. Look at all of the press the FDA and medical community is getting over cold medicines... Parents are told to NOT give medicines to infants/toddlers less than 2 yrs, and they do it anyway, and then get upset when there are poor outcomes and now NOBODY can give anything to children less than 6 yrs old. There is way more to this whole dilemma than the FDA and NIH; Intel dealt with computer chips and hopefully didn't put something into someone's body. We're talking apples and oranges...

The people who rose to the top of the current system got there by playing by the old rules. If you are going to change the system, you have to create separate hybrid systems that can be sheltered and protected -- kept a little longer in the incubator.

Kerry O'Connor