Make sure that the pharms get the message that when it comes to initiative innovation, they are the Z team. I could go on and on like Tena and Paula, but i just ain't got that much jam anymore cs

you cannot argue that we haven't really moved on from l-dopa.

However having been in IT all my working life I am not sure I want my meds developed to the same level of quality as my IT. Remember the famous GM riposte to Microsoft, at a computer expo (COMDEX), Bill Gates reportedly compared the computer industry with the auto industry and stated "if GM had kept up with the technology like the computer industry has, we would all be driving $25.00 cars that got 1,000 miles to the gallon."

In response to Bill's comments, General Motors made the following contribution to the debate:

"If GM had developed technology like Microsoft, we would all be driving cars with the following characteristics:

1. For no reason whatsoever, your car would crash twice a day.

2. Every time they repainted the lines on the road, you'd have to buy a new car.

3.Occasionally your car would just die on the motorway for no reason, You would have to pull over to the side of the road, close all of the car windows, shut it off, restart it, and reopen the windows before you could continue. For some reason you would simply accept this, restart and drive on.

4. Occasionally, executing a maneuver would cause your car to stop and fail to restart and you'd have to re-install the engine. For some strange reason, you'd accept this too.

5. Occasionally, for no reason whatsoever, your car would lock you out and refuse to let you in until you simultaneously lifted the door handle, turned the key and grabbed hold of the radio antenna.

6. You could only have one person in the car at a time, unless you bought a "Car 95" or a "Car NT". But then you'd have to buy more seats.

7. Macintosh would make a car that was powered by the sun, twice as reliable, five times as fast, twice as easy to drive - but it would only run on five percent of the roads.

8. The Macintosh car owners would get expensive Microsoft upgrades to their cars which would make their cars go much slower.

9. The oil, engine, gas and alternator warning lights would be replaced with a single "General Car Fault" warning light.

10. People would get excited about the "new" features in Microsoft cars, forgetting completely that they had been available in other cars for many years.

11. We'd all have to switch to Microsoft petrol and lubricants but the packaging would be superb.

12. New seats would force everyone to have the same size ****.

13. The airbag system would say "Are you sure?" before going off.

14. If you were involved in a crash, you would have no idea what happened.

15. They wouldn't build their own engines, but form a cartel with their engine suppliers. The latest engine would have 1 cylinders, multi-point fuel injection and 4 turbos, but it would be a side-valve design so you could use Model-T Ford parts on it.

16. There would be an "Engium Pro" with bigger turbos, but it would be slower on most existing roads.

17. Microsoft cars would have a special radio/cassette player which would only be able to listen to Microsoft FM, and play Microsoft Cassettes.Unless of course, you buy the upgrade to use existing stuff.

18. Microsoft would do so well, because even though they don't own anyroads, all of the road manufacturers would give away Microsoft cars free,including IBM.

19. If you still ran old versions of car (ie. CarDOS 6.22/CarWIN 3.11),then you would be called old fashioned, but you would be able to drive muchfaster, and on more roads!

20. If you couldn't afford to buy a new car, then you could just borrowyour friends, and then copy it.

21. Whenever you bought a car, you would have to reorganize the ignition for a few days before it worked.

22. You would need to buy an upgrade to run cars on a motorway next to each other.

23. Every time Microsoft introduced a new car, car buyers would have to learn to drive all over again because none of the controls would operate in the same manner as the old car.

24. Microsoft would require all car buyers to also purchase a deluxe set of Automobile Association Road maps (now a Microsoft subsidiary), even though they neither need nor want them. Attempting to delete this option would immediately cause the car's performance to diminish by 50% or more.

25. You'd have to press the "Start" button to turn the engine off.


Remember, software and sausages, you don't want to know what goes inside either.

Peace and love,
Neil.

Thanks for a good laugh.

Andy Grove is taking a beating but I think he knows what he is doing. He once said in an article that he liked lots of arguing and debating to be going on in all the offices; that's how progress is achieved. He has everyone 'quacking' like wild ducks, but a little off topic. I have much more to say when I come out of my blog fog. where I have done some quacking myself all day yesterday.

paula

Pharma Live



This was a week of people speaking up and then running into the verbal equivalent of a sandblaster to the face. Former Intel executive Andy Grove managed to infuriate just about every single pharmaceutical researcher, and Eli Lilly executive Diedre Connelly managed to infuriate just about every single sales rep, especially those on Café Pharma. This week was also marked by Merck’s Vioxx settlement, as well as a settlement by Cephalon for off-label marketing practices.

When worlds collide
Yes, lots of folks had a lot of things to say about Mr. Grove’s interview with Newsweek, in which he complained that for all the advancements in medicine there still is not anything better to treat Parkinson’s disease than levodopa, and that the industry’s researchers can learn something from the semiconductor industry. Oh my. As expected, his words of wisdom were received with less-than-overwhelming enthusiasm. Dr. Derek Lowe of In the Pipeline had some interesting things to say in response, in which he picks apart some of Mr. Grove’s arguments.

“Mr. Grove, here's the short form: medical research is different than semiconductor research,” Dr. Lowe says. “It's harder. Ever seen one of those huge blow-ups of a chip's architecture? It's awe-inspiring, the amount of detail that's crammed into such a small space. And guess what — it's nothing, it's the instructions on the back of a shampoo bottle compared to the complexity of a living system.

“That's partly because we didn't build them. Making the things from the ground up is a real advantage when it comes to understanding them, but we started studying life after it had a few billion years head start. What's more, Intel chips are (presumably) actively designed to be comprehensible and efficient, whereas living systems — sorry, Intelligent Design people — have been glued together by relentless random tinkering. Mr. Grove, you can print out the technical specs for your chips. We don't have them for cells.”
Some might argue with Dr. Lowe that we do have some technical specs now, particularly the human genome. The industry’s defenders will point out that the actions of many living cells are still largely not understood.

Dr. Lowe’s readers largely agreed with his view. Compare these comments, however, with the comments to the Newsweek article, from people who for the most part are not pharmaceutical researchers.

Many of the people with Parkinson’s disease were mourning the abandonment of the synthetic GDNF liatermin by Amgen. You can find out more about how these patients feel about liatermin here. Amgen’s critics do bring up a good point in that the company has pretty much sat on liatermin and does not seem to be developing the drug. That smacks a bit of a dog-in-the-manger attitude. But it would not be quite fair to force Amgen to sell or give liatermin to another developer, especially if that new developer actually manages to bring the drug to market. Licensing the drug could be an option, though, and would give Amgen a share of the revenue if the drug makes it to market.

As a clear example of how science is messy and when it comes to drug development there is still a lot we do not know, we can point to TeGenero and the saga of TGN1412. Remember that? You can read the Institute of Clinical Research’s report here, which concludes that the adverse reactions were caused by “an unpredicted biological action of the drug in humans,” but that still does not tell us why the Phase I clinical trials went so drastically wrong. There are all sorts of theories about what happened. Was it this reason? Or this reason? Was it this reason? Whatever the ultimate cause was, the effect was even more caution from the United Kingdom ’s MHRA on letting complex monoclonal antibodies begin human clinical trials. That brings up the point so many researchers make, that the government regulatory bodies are part of the problem, demanding more clinical trials, more information, etc.

Ed Silverman at Pharmalot says despite executives’ complaints about regulatory foot-dragging, “Someone else thinks the slow rate of approvals is your fault.”. FDA Deputy Commissioner Janet Woodcock told Fortune that the slower rate of approvals is because FDA is receiving fewer new drug applications.


http://www.medadnews.com/magazines/medad/

the FDA held meetings this week to talk about the drug regulatory process in the wake of the Vioxx failure. Our very own Greg Wasson (accompanied and ably supported by his wife, Ann (AJ) Wasson) was invited to speak; he was the ONLY patient there among top FDA officials and drug and pharma research gurus. They treated him well; kept him upfront and visible as a patient as the other participants talked about statistics and market realities.

Amy Comstock Rick and the Parkinson's Action Network have worked hard to get PD input into the top tiers of decision making in the nation. This is what Greg said (preceded by an introduction from the PAN website):

The Parkinson’s Action Network participated in a Food and Drug Administration (FDA) hosted conference on November 6-7 entitled “Assessing Drug Benefits and Risks in Regulatory Decisions: Framing the Need, Evaluating the Tools, and Deciding Next Steps,” in Silver Spring, Md. The conference attendees were primarily FDA regulators and representatives from the pharmaceutical and biotech industries.

PAN California Congressional Coordinator, Greg Wasson, J.D., who has been a grassroots advocacy leader at PAN for over a decade addressed the conference on the first day. In addition to participation on a panel, Greg gave sophisticated remarks on patient involvement in benefit-risk decisions and the need for enhanced decision making tools in the 21st century.

The following are his remarks:

"Good Afternoon. Thank you for inviting me to speak as a patient advocate at this meeting. Because I have a currently incurable, progressive degenerative brain disease, I am going to finally heed the advice of my neurologist and read from text for this talk. I should start by telling you a little bit about myself. While in many ways I am increasingly the typical 21st century patient sitting in the doctor’s waiting room or standing in line at the pharmacy, in other significant ways I am an atypical patient. The differences between the two may present the biggest challenges to creating effective decision-making tools for patients if we are serious about giving patients as a class a meaningful seat at the health care policy table, and real power as individual patients to make, or meaningfully participate in, decisions in the management of their own health care.

I am a typical 21st Century patient in the following ways: I am middle-aged. I have chronic co-morbidities, including Parkinson’s disease for (which I’ve had for 12 years), type II diabetes, and hypertension. I passed by my ideal weight 20 pounds and 20 years ago. I take nine different prescription medications multiple times daily to help manage my diseases and their symptoms. As I am speaking, there is a small device behind and inside my left ear, which feeds an altered and minutely delayed reproduction of what I have just said into the auditory and speech channels in my brain (I also hear it consciously – it sounds a little like Mickey Mouse on helium), which makes it possible for me to speak at sufficient volume and with enough clarity to be understood despite the speech degeneration caused by my Parkinson’s. Increasingly, such complex combinations of illnesses and their symptoms and possible treatments are becoming typical of the kind of matrix that patients, doctors, and the health care system generally will have to deal with as we move from a system built on acute care to one focusing on the care management of an older population with multiple chronic health problems.

I am also an atypical patient. I was a lawyer and a book editor, which places me above the mean in education. Both my profession and education have given me skills that help with problem solving, locating and synthesizing information, and working my way through texts that frequently include words and terms that are new to me. I have been a Parkinson’s disease advocate for a decade, which has familiarized me with the current systems and networks for the provision and regulation of health care beyond even the average well-educated lay person. I use the Internet and know how to search for information relevant to my health care. English is my native language. Lastly, I am a white male, which gives me less quantifiable but important cultural and social affinities with most health care professionals.

This conference has included patients as stakeholders and decision-makers in the management of their own health care and its regulation. The Parkinson’s Action Network (PAN) applauds this as an example of the FDA’s response to the general criticism that the missing voice at the healthcare policy table is the voice of the patient. I think it is vital that the patient voice be included not only in individual health care decisions, but at every level of decision making, including IRB’s, Advisory Committees to PhARMA and Biotech companies, and relevant government agencies. Patient participation in health care decisions still has a long way to go before it is an accepted fact and not just a platitude, but thankfully we are making a start.

For the patient to participate as a full-fledged stakeholder in today’s health care environment, we must overcome a health care culture stretching back generations. This culture has regarded the patient as a passive and uninformed recipient of the specialized knowledge and training possessed in some measure by everyone else here today. A patient’s unsolicited input or questions about diagnoses or treatment protocols have traditionally been met with an attitude of “you worry about your insurance (or lack of it), and I’ll worry about how to treat you.” More often than not, patients accepted and even encouraged the assumption that doctors, researchers, drug companies, and government regulators were responsible for and capable of fixing what ailed them. It was comforting to think that the people in the labs coats—one part scientist, one part magician--had solutions to all of our medical problems. Gradually, however, more and more patients have been disabused of that comforting but erroneous notion.

The idealization of medicine hasn’t completely disappeared, but two factors are hastening its demise. First, physicians increasingly have less time to spend with each patient, reducing both the time that the physician has to get a clear picture of the particular patient and the problems he or she presents, and to give the patient a clear understanding of a chosen or proposed treatment. Secondly, we now have an active patient population that increasingly wants and needs to have a voice in the decisions made about its health care. That population--particularly the growing number with chronic illnesses like Parkinson’s that require a lifetime of treatment decisions as the disease progresses--needs tools to assess risk and benefit in managing their care.

That said, all of us here today, including patients and their representatives, must recognize that the average patient, while integral to the processes of both individualized health decisions and the broader area of healthcare policymaking, is unlikely to have specialized training in medicine, pharmacology, biologics, the systems and organizations that provide healthcare, healthcare policy language, or the Code of Federal Regulations. We run a great risk in simply handing over to individual patients an array of treatment options to choose from as if they were a smorgasbord without also providing the tools that they need to make informed decisions. Likewise, we must create tools by which the unique perspective, which only patients can give as to the experience of their illness and its treatment can be captured and used to better inform the policymaking process. Creating these tools will not be simple or easy, but create them we must if we are to make the once passive recipients of health care decisions made by others into effective and meaningful collaborators in developing healthcare policies and practices which will meet the new requirements of a new century.

With regard to decision-making at the individual level, I think the most basic need of the typical patient is access to information that is relevant to his or her individual health profile. This information must be easy to find and as easy as possible to understand. Patients need a tool to find their way through the incredible mass of information they don’t need, or can’t hope to understand, and locate the information they do need and can understand without specialized training or experience. I think that ultimately, the most usable tool will be a web-based, user-friendly data site. It may be part of Medwatch. It may be a clearinghouse for data already online. It may be an entirely new Web site devoted to this particular purpose. It does need to be available and usable by ordinary patients trying to make informed decisions about their care.

The patient must also know that the tool exists. Information about it must be broadly and consistently distributed through a variety of information portals. These might include television and radio PSA’s, much like Direct to Consumer advertising, informational brochures distributed through doctors offices, hospitals, clinics, and pharmacies, advertisements on patient forums or patient advocacy sites, and relevant government Web sites. Whatever the method or methods, the patient population must know about the tool in order to use it. And if the tool does take the form of a web-based data access point for patients, there must be an agency or panel willing to step up and take responsibility for ensuring that the tool is as accurate, up-to-date, and easy to use as possible.

At the policymaking level, all of us here today will gain by creating tools that provide more data about what patients are thinking about their diseases and their treatments. A recent study in Europe showed that information derived from online patient forums turned up serious adverse events that had not yet been reported or detected. With due consideration for patient privacy in such forums, data mining of this type could be an extremely valuable tool in assessing post-approval responses to medications. Polling patient populations has also uncovered otherwise unrecognized symptoms as basic as pain in Parkinson’s patients. Finding out what patients are talking about and thinking in something like real-time is vital to move quickly in covering and responding to issues that arise after medications are in the marketplace.

To sum up, we need both the typical and the atypical patient or patient representative as participants in healthcare decision-making. Typical patients will increasingly be called upon to actively participate in the management of their own health. In turn, the typical patient needs the atypical patient or patient representative, more familiar with the intricacies of the health care system and its policymaking apparatus, to provide the patient perspective on committees, councils, boards -- industrial, governmental, and academic -- wherever discussions are being held and decisions made about health care policy and practice. Having the patient involved in the process of drug trial, approval, labeling, and post-approval monitoring, provides not only invaluable information and perspective for health care providers, the drug and biotech industries, and regulators, but empowers patients, increasing their ability to make informed choices, and provide valuable data, about their own health care.

Adding the patient perspective to policymaking will improve those policies. Having the patient perspective at the front end of the pipeline will result in fewer problems or surprises downstream. By recognizing and addressing the need for comprehensible, easily accessible information available to all patients, we can make the average patient a genuine and effective decision-maker in the increasingly complex world of health care."

It seems that a few comments about Andy Grove have disappeard from the Internet..battle of the superpowers or am I just paranoid or naive?

paula

Congratulations Greg - i talked to him last night.

http://pdpipeline.org/andygrove/agrove1.htm


scathing? hardly - he's obviously given this some thought......

hats off to him!
paula

Silly girl. I was ahead of you by many minutes, Paula...ha ha ha

most people are Carolyn.....especially you.....lol...i hope you keep getting faster and faster too!

paula

oh and you can spell better too....as demonstrated in the post title

Terrific speech! Well done!