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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Cacaito who wrote (10825)	7/16/1999 11:45:00 PM
From: Bluegreen	Respond to of 17367

Cacaito, now that was one of the best posts I have ever read. The only two complaints I have in regard to the FDA is the way they have efficacy standards setup and they can always improve on monitoring safety of products. Once again, excellent post in my opinion.

To: Cacaito who wrote (10825)	7/17/1999 2:31:00 AM
From: Tharos	Respond to of 17367

Japan Inc.'s main goal has been full employment. R&D is expensive. It's much easier to let others pay development costs, and you pay for refinements. That aside, there are cultural reasons why there is not a thriving biotech industry here. One of the most apparent is that Japanese do not place the same obscene value on life that Americans do. Japanese families will not bankrupt the family to keep one member alive. It has only been in the last 5 years that ambulances have become more than just a higher speed transport system for the sick and injured. Turn the clock back a few years and you will not find even oxygen on the ambulances. Now you find O2, but a Japanese ambulance is still nothing compared to the US version. It all boils down to Karma. If your Karma is to die in route to the hospital, then so be it. I strongly suspect their nationalized health system is also to blame, which makes me wonder why the Democrats are trying so hard to socialize America's health care system. Anyway, this is changing with the younger generation. They have much more money than their parents did.

To: Cacaito who wrote (10825)	7/17/1999 2:36:00 AM
From: jackie	Respond to of 17367

Wonderful post. Several items I will have to give serious thought to. By the way, only 20% of the medical procedures in common use have clinical trials to justify their use. Treatments for common ailments vary greatly among the industrialized countries, yet prognosis for each are comparable. By pass surgery is a good example. Common in this country yet rare in Europe. If it were truly efficacious, you would see significant differences in cardiac deaths. But we don't. Another little zinger. Use of tobacco in this country actually ends up saving our society money in the long run. Premature deaths caused by tobacco lower social security payments, more than offsetting the extra expense in treating tobacco related ailments. That curious tidbit from an article in the Economist a few months ago. Here are some other thoughts: Why would anybody reverse engineer a drug unless it were efficacious? If true, why not set the test of efficacy to be the number of imitations? Could the role of the FDA be slightly modified to that of the official score card keeper on the efficacy of drugs? That is, once a drug is found not to be harmful, the FDA keeps track of its clinical history, available for all to the see on the web. Failure to report negative reactions on the part of the drug company would make it completely without defense in the courts. The opposite would be true. If negative effects are reported, company buys for itself immunity from lawsuits for those effects. Such an arrangement would have stopped the breast implant nonsense in its tracks. It's official now, or as official as it can get: there is no scientific evidence what so ever to suggest silicone breast implants have anything to do with the immune problems claimed by some. But that won't change a thing. The companies involved still have to pay up. If the FDA played the scorekeeper role suggested above, there would have been no basis for lawsuits, even if there were legitimate damages. The company could argue, "Hey look, we told you there was a 27% chance your leg would fall off if you had a breast implant. And your leg fell off. It was your choice." Of course, such a defense would hamper the marketing efforts of the company, but that's ok. But at least the worst of the legal abuses of this nature could be stopped. Intellectual property rights must be protected if we are to enjoy the fruitage of intellectual labor in any field. We could have strong intellectual property rights protection without efficacy requirements on the part of the FDA, could we not? Why not have cost benefits analysis sponsored by insurance industry? Would it not make sense for an insurance company to reduce premiums for those individuals taking drugs proven to reduce hospital stays or deaths? Example: lipitor. Costs of providing experimental treatments could be borne by those standing to benefit from their success. These could include insurance companies, drug companies, medical device manufacturers, and yes, the public through tax dollars. I would expect physicians doing such work to at least reduce their fees as in long run, they would stand to benefit from procedures or techniques of truly beneficial quality. All results from such studies would be made public as soon as possible. And why should only new procedures undergo such scrutiny? Why not check up on the costs benefits of all procedures? Insurance industry doesn't want to pay for them. Neither should the government. Patients shouldn't want useless procedures or drugs either. This whole health care debate is filled with endless permutations. I know there must be many holes in my suggestions above. But I don't think we can stray too far from what most would agree is the right thing to do if we hold to the notion of informed choice in health care. True informed choice. Not choices based on inaccurate or incomplete information. Nor on choices artificially restricted by an imperfect government agency insisting on its own rulings. But thanks for a great post. Regards, Jack

To: Cacaito who wrote (10825)	7/17/1999 10:43:00 AM
From: aknahow	Read Replies (2) \| Respond to of 17367

Interesting post with good points and yet when I agree with you that some drug companies and even some biotech companies do want the FDA involved in determination of efficacy for the very reasons you cite, I see that as harmful to the public not good. Managins product was turned down because it was not more effective than existing products, even though it offered a different approach from conventional antibiotics. The established companies may want barriers to competition and determination of effectiveness is a big barrier. IMO Latin America permits selling of "effective" drugs without much control. The problem is not so much of the drugs being ineffective. But I am sure you have seen the other side where the drug salesmen are king and push anything that works or not. Still think the tendency is to push powerful drugs that have safety concerns. Xoma might fall into the group of companies that prefer the system as is. My proposal is not based on what is good foe Xoma. Lawsuits provide adequate protection against those that would use ineffective but safe drugs rather than effective ones that are also safe. The point I liked best in your post, is one I have no answer for. If I am right then why is Japan not a flourishing haven for biotechs? While not an answer, I have a question. Is it perhaps the size of the market? If they required efficacy as well as safety would they have any biotech industry at all? Don't know, just a question.