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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: David Bogdanoff who wrote (2317)	10/31/1998 9:29:00 PM
From: jackie	Read Replies (3) \| Respond to of 4676

David, First of all, drugs are products, not services. The FDA regulates drugs, not the health care industry. Second, the Thalidomide tragedy would not have been stopped by even today's regulations for the simple fact we do not test drugs on pregnant women, unless they are intended for such. Thalidomide would have sailed right through the entire Phase I, II, III programs without a hitch. There were no side effects for the intended population. It would have been only later, when the birth defects started showing up that the FDA would have done what it has done for several drugs recently, recalled them. Had this been the sequence of events, naturally every one of the victims of this approved drug would have contacted their local friendly lawyer and started suing everyone in sight, starting with the doctors writing the prescriptions. Which demonstrates the third point, FDA drug approval does not give immunity to a doctor prescribing drugs. Interestingly, the only ones enjoying legal immunity are those working for the government. They want to control your life, but they are not accountable to anyone if they are wrong. This is because they 'mean well.' Fourth point: All drugs have unknown and dangerous side effects to someone at sometime, even aspirin or vitamin C. The FDA doesn't know all the potential side effects for everyone for every drug. By definition, unknown side effects are, well, unknown. What we want to be protected from are people selling us products, including drugs, they know to be dangerous. I have no argument at all with safety testing, provided all of the information is made available to me. There is no need at all for the government to be involved with this. Consumer's Reports does a nice job of reviewing products. I would most certainly take their word for it. In fact, I would believe them long before I would an agency of the government for the simple reason such agencies are subject to manipulation. I cite the recent examples of Olestra and Monsanto's genetically engineered potatoes. The former has absolutely no redeeming qualities except for enhancement to the producer's bottom line. There are indications from people I place my confidence in that Olestra can cause serious long term health problems by preventing the absorption of vitamins. That may be incorrect, but at least you and I have the option of discussing the merits of the position and are free to make our own choice. The latter case of the potatoes is a little more serious. Monsanto did not even have to bother with the FDA. These genetically engineered potatoes contain pesticides produced by genetic instructions placed there by the company. Through some bizarre suspension of logic and reasoning, the FDA determined it had no jurisdiction over these potatoes. Potatoes containing a poison. Potatoes to be consumed by millions of unsuspecting consumers because, and this is really strange, there is no labeling required on these potatoes indicating they contain pesticides!! So what was it you were saying about 'unknown' and 'dangerous' side effects? Meanwhile, many worthwhile drugs are tied up and people are prevented from using them, even if they agree to accept the consequences of trying an untried drug, because someone is taking their time in making the drugs available to them. Take the drug Isis is testing for Crohn's disease. If I'm suffering from Crohn's disease, why can't I inform myself of the pros and cons of the drug, and, after releasing everyone from liability, have the drug given to me? In fact, why couldn't I simply be registered as one of those having tried the drug? I would even be willing to have my medical history and experience made public, minus my name of course, so others might benefit from my experience? Why is it I can't get many drugs deemed safe in other countries? Is the physiology of say a Frenchman that much different than mine? Couldn't I seek the advice of someone whose judgement I trust, such as my own personal physician, to evaluate the suitability of a particular drug? Why does anyone in Washington or anywhere else need to get involved? After all, I'm the only one affected. These same people let millions of individuals take drugs with plenty of side effects, just to feel good. I am referring to alcohol and tobacco. Everyone just shrugs their shoulders and says, 'Their choice.' Can't we say the same about these drugs being produced by Isis or Merck or anyone else? Of course, I will obey the law. But the arrangements we have in this country are not accomplishing what was intended. By the way, companies developing drugs could secure patent protection for their drugs, again completely independently of the FDA. Regards, Jack Simmons