Sex, Drugs, Money, Heated Discussions, Trips to Ireland. Vivus has it all! Comments on many posts.
TRIP TO IRELAND: SEE BELOW
MONEY:
Most of the medical types on this board think that Vivus has great long term potential. This is based on what we think the market is. This drug is related to other drugs with known serious side effects, including the granddaddy of them all, death. These drugs have what is known as a low toxic to therapeutic ratio. This is the amount of drug that will cause toxicity vs. the amount of drug that is needed to induce a therapeutic effect. For some drugs this is very low (e.g. 2). This means that if a person takes a double dose, that the drug will be at a toxic level. In contrast, a drug with a ratio of 1000 would mean that a patient could take 1000x the therapeutic dose before reaching a toxic level. (Please MDs don't argue about drug levels, absorption, metabolism, etc. I'm trying to get to the basic point here.)
To return to the issue: Viagra is in a family of drugs with a low toxic to therapeutic ratio. There is very little published information on this drug, therefore one cannot determine by looking at the literature whether this drug has a low toxic to therapeutic ratio. This is obviously an important issue as it is LIKELY that many patients will try taking a double dose. This issue will probably be addressed in the FDA studies although these studies are most likely to have been done on healthy subjects. Hopefully (from a medical standpoint) some smart reviewer requested toxicity studies in the at-risk target population (i.e. diabetics with heart disease) but I have my doubts.
Now, even if Viagra is in a family of drugs (PDE inhibitors) with a low Toxic/therapeutic ratio, this doesn't mean that Viagra is a toxic drug. Given the dearth of information, all that MDs can do is draw analogies to other drugs. So the TA vs. BigKY controversy is over which drugs are the most suitable prototypes for drawing conclusions. PDE III inhibitors have known toxicity (bad heart rhythms sometimes resulting in death).
However, Viagra is a PDE V inhibitor. So this issue is whether this PDE V inhibitor is likely to have the same effects as the PDE III inhibitors. I personally do not know the answer to this question. I've started looking into it but haven't reached any conclusions. For anyone who wants to check, I think a good way to go would be to look at studies of binding and function of PDE V vs. PDE III inhibitors in basic biochemical studies. Post 4817 has a good article relating to this issue. However, looking at these biochemical studies will not really tell us how safe these drugs are in patients. We won't know that until the drug has been out for the first year or so.
My opinion on the drugs discussed: persantine: used for limited indications only, not commonly thought to be toxic. theophylline: clearly a bad actor, low toxic to therapeutic ratio, used to be used in almost every asthmatic but recently has lost favor although I think there is a moderated return to its use in a limited population; cardiac drugs: thought to be associated with increased deaths in heart failure patients.
Incidentally, I believe that the FDA is only required to review applications within one year, unless they do an expedited review, in which case, it is 6 months. Someone posted that the NDA (new drug application) was submitted in September of 1997 and the approval was expected in March of 1998. The FDA thinks it's great if a review comes in one week early and late night approvals on the last day are not unheard of (they lose money if the application is not approved on time). Since submission of NDAs is not public information unless the company releases it, I am wondering if there is an authoritative source or a rumor that this application was submitted in September and that it is undergoing expedited review. I have guessed this from the news releases, however it would be helpful to know the facts here.
PUBLIC RELATIONS
Pfizer must have a great public relations department. I don't see anything nefarious going on here beyond that. Think about the Newsweek article from about November that discussed the new treatments for impotence without mentioning Muse except to dis it as ineffective. Remember, reporters are not usually medically trained, plus they have deadlines to meet.
One of the most interesting magazines that I read is the New Republic. No pictures, single authored articles. However, I notice that often I will read something in the New Republic, then it gets picked up by the popular magazines and news services. It is very heavily read by journalists and in Washington (of course, we don't care about Washington). There are two interesting articles here that might appeal to them or to other "opinion leaders." First, it is clear that there is a David and Goliath situation here with a heavy duty PR department managing to pull the wool over the eyes of several reputation news services (Newsweek, NBC, Barron's, etc.). Second, online investing is really much more active, useful and interesting. The Vivus thread itself is great. It has everything (sex, drugs, money, fights, blow-by-blow schedules for sex, sex and drugs, sex). What else does one want? Now this would be an interesting story. The down side is, it might dilute the thread and I cannot keep up with this thread now.
There are other venues for PR. I hope that the Vivus PR department will really try to pursue these. One article in the Ladies' Home Journal (How to help your man ) would do a lot more than millions in advertising. Pfizer knows this.
DEA SCHEDULING
Please, don't even suggest to the DEA that they schedule a drug. This is not in a class of drugs that is usually scheduled. They might think about it themselves if there are pharmacy break-ins to steal the drug or evidence of dependence in users (i.e. dependence on the drug, not when used for therapeutic purposes). Have any of the urologists seen evidence of this? I have not heard about it with any other related drugs.
DRUG DISTRIBUTION
In this corner we have TA and in that corner, BigKY, arguing about blood flow to the kidneys vs. the brain. Most drugs are picked up in the blood and distributed via the blood. However, where the drug ends up is only partially affected by the blood flow. If a certain tissue binds a drug very tightly, then most of the drug will end up there. This is because, sooner or later the drug will fall off the less tightly binding tissue, float around to the tighter binding tissue and stick there. There are also issues like non-specific protein binding and getting broken down in certain tissues, particularly the liver but sometimes other places especially in the lungs and kidneys. So I don't think blood flow is that important an issue. (Based on previous posts, I'm sure this will be a HOT HOT issue. For the non-medical types, I've finessed many issues in this brief summary and probably all the criticisms will be true).
EDITORIAL PAGE
Sex: don't you guys KNOW that "manly" men who need Muse don't watch the Super Bowl. How could you even imply it?? This is the same country where presidents and military officers aren't supposed to have sex with anyone besides their spouses. Those of us who work with real people know that Peyton Place was a toned down version of real life. Yet this discrepancy between real life and private behavior is increasing and I anticipate a return to 80s ("just say no") and 50s style repression. Anything you say can and will be used against you in the court of public opinion.
TRIP TO IRELAND
What you've all been waiting for...Well, a while back I tried to get our webmistress to organize an SI conference. Someplace not too expensive so we could all save our money to put it in the stock market. That didn't fly (she says they don't have the resources). However, I think that Ireland would be a nice place to go and it would be tax deductible (we could go on a plant inspection, or at least look at the plant site). Other possible trips include the Caribbean or California. Way down on the list is New Jersey. We could all stay at Blankmind's house and go to visit the Vivus plant at midnight.
Well, I have a basketball game to go to: Hanover Hurricanes vs. Indian River. The third and fourth grade girls battle it out! LB |
