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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: BigKNY3 who wrote (18979)	2/21/1999 2:52:00 PM
From: VLAD	Read Replies (3) \| Respond to of 23519

BigP, Why is it that if you have NO position in Vivus that you constantly monitor this board and always interject whenever I post anything that is antiViagra? Don't play dumb because I know you are smarter than that. Although I have no ability to predict what the FDA will or won't do, I believe that Viagra is an unsafe drug in the CVD population and is not properly labeled warning as such. IMHO the drug should be pulled until a double blind study in the CVD patient proves one way or another if Viagra precipitates coronaries in the CVD patient. Also, longer term studies need to take place to determine what the effects of chronic Viagra use is on retinal function. Viagra is a lifestyle drug that IMO is killing people! There are safer alternatives already available including MUSE and needle therapy. Just because Viagra is the only oral medication for ED is a very lame excuse to allow it to remain available while the safety profile is very questionable at best. As far as how Viagra bad news effect MUSE sales, the only news I desire to hear is that the FDA at least changes the label from its latest cautionary statements to a black box which should read: DUE TO ITS HYPOTENSIVE EFFECTS, VIAGRA SHOULD NOT BE PRESCRIBED TO PATIENTS WITH UNDERLYING CARDIOVASCULAR DISEASE. DOCTORS NEED TO DETERMINE THEIR PATIENTS CARDIOVASCULAR STATUS BEFORE PRESCRIBING VIAGRA. If and when this occurs, it will mean that MUSE specificity will improve as it will be the drug of choice for the CVD patient with ED. I don't give a hoot about a short term pop in Vivus share price because of some type of bad news concerning Viagra. In fact I would like to hear some GOOD news concerning Viagra. The black boxing of Viagra is GOOD news for everyone that counts(except you) in that it will save human life and increase MUSE specificity. Touche

To: BigKNY3 who wrote (18979)	2/21/1999 3:30:00 PM
From: VLAD	Read Replies (1) \| Respond to of 23519

Read this: citizen.org Scary stuff! We have 2 completely opposite view points here. 1)The big Kahuna type that is only concerned about his investment portfolio in big pharma drugs and gets excited every time another pill is approved to be pushed to the American public. I believe Celebrex an over priced anti-inflammatory that is attempting to claim (falsely so) that it doesn't have any GI effects of decreased stomach mucus production as does all other NSAID is the latest scam that the Kahuna is peeing in his pants over. 2)The Public Citizen's Group which is an organization founded to protect the public interests over big pharma's profit interest and is supported by over 150,000 American citizen's nation wide. There is NO financial motivation in the PC's decisions. They just don't want to see ineffective or dangerous drugs sold to the American public for the sake of big pharma profit over patient safety concerns. Kahuna, I am NOT anti-big pharm nor I am I an anti-precription drug advocate but the way the American big pharma companies compete amongst each other as a race against the clock to see who can come out with the next drug to get a larger piece of a particular drug group pie IMHO places a priority of big pharma profitability over consumer safety. You know this industry all too well to deny this game that constantly takes place in this industry. One way a big pharma company can get an "edge" over the competition is to contribute large amounts of money toward political campaigns and towards Washington lobbyists to promote their agendas. Pfizer has been at the forefront in buying the political clout needed to get its way in circumstances where a small company like Vivus wouldn't stand a chance.

To: BigKNY3 who wrote (18979)	2/21/1999 5:15:00 PM
From: VLAD	Respond to of 23519

BigP, Here is a little reminder of the quickly forgotten survey done by the PC on the Medical Advisors who work for the FDA deciding which drugs should or should not be granted approval: citizen.org I would just like to point out a few statements from this survey which I believe specifically refer to drugs such as Viagra and I am also predicting that if and when more stringent Viagra labeling occurs then this survey hits the nail right on the head in predicting exactly how the system works over at the FDA. I have to go now but will be back tonight to do a point by point review of this survey to remind everyone--especially the Kahuna as to exactly how this game is played. Here is a brief outline to show you how it works listing where the power is in descending order: 1)Big pharma money influencing politicians on Capitol Hill. Note that Pfizer is fifth on the corporate list as far as money spent on Washington lobbyists. Also, let's not forget the millions Pfizer spends on political campaign contributions. Pfizer doesn't give this money away out of the goodness of their corporate heart. They expect that politicians that they supported will support their interests when it comes to Congress using its political clout to pressure decisions on the burocrats in the FDA. 2)Next in line in terms of decision making power are the higher ups at the FDA. If they get pressure from the Hill to fast track a drug or to not scrutinize a drug too much they will certainly buckle to this pressure. If a drug is under review and the application is made by a small company that can't afford to spend money for political campaigns then the drug does indeed get a fair review without having the influence of higher up politics in its favor. 3)Next on the totum pole of power is the Medical Advisors who actually try to do the scientific work to determine if a drug is both safe and effective. The only thing effecting their power is the political pressure above them that easily over rides their scientific opinions. 4)Last on the totum pole is we the consumer. We naively assume that if a drug is FDA approved then it has got to be safe. Too bad that many believe such misconceptions. Big money comes first, then politics, then scientific fact and finally the public welfare. Too bad but that is the way the system really works. As one Medical Officers said regarding the drug approval process, "My feeling after 20 years at the FDA is that unless drugs can not be shown to 'KILL' patients outright then they will be approved with revised labeling and box warning." So far Viagra has had its first step towards rectifying its true safety profile via the FDA revising the label. Notice how the announcement of the revised labeling came out at the same time that a long overdue update on Viagra fatalities was released? Notice how Pfizer doesn't dare specifically advertise Viagra on television because they would have to mention that men die after taking Viagra? The Pfizer marketing team was wise enough to decide just to discuss erectile dysfunction in their rosy "We save lives add" or in their Bob Dole commercials. The next step is black boxing of Viagra. Question is exactly how high does the body count get before we see that long overdue black box if ever? I thought it was 50 and then 100? Maybe 200? Do I hear 300? Kind of tough to get a fair shake on this situation when Capital Hill is controlled by males who are mostly over 55 years of age!

To: BigKNY3 who wrote (18979)	2/22/1999 1:25:00 AM
From: VLAD	Respond to of 23519

Kahuna, As promised I will now produce a series of posts reviewing some of the highlites of the survey done by the PC on the FDA Medical Advisors. Of course in your eyes the PC is some sort of lunatic fringe group that has it in for big pharma. Let the readers decide for themselves: citizen.org

To: BigKNY3 who wrote (18979)	2/22/1999 1:29:00 AM
From: VLAD	Respond to of 23519

Lowered FDA Standards For New Drug Approval "The agency is allowing a lot of 'me too' drugs on the market which are LESS SAFE or less efficacious than existing drugs already approved and marketed in that drug class."

To: BigKNY3 who wrote (18979)	2/22/1999 1:34:00 AM
From: VLAD	Respond to of 23519

More Rapid Drug Approvals "Rapid approval often means insufficient time to examine carefully original data, accepting 'on faith' validity of randomization, screening, use and misuse of inclusion and exclusion criteria. There is insufficient time to discuss outlying observations." "Medical Officers don't approve NDAs. We simply recommend for or against approval. Office directors make the final decisions."

To: BigKNY3 who wrote (18979)	2/22/1999 1:43:00 AM
From: VLAD	Respond to of 23519

Approving a Greater Proportion of Drugs "Everything is approvable. We can use labeling creativity to lower the problems." "Pressure to approve comes largely from the Office and Center level. Decisions should be left with the Division--that is where the expertise is." "In the last two years, I recommended that two drugs not be approved. They were approved without consulting me. This never happened before. In one case the drug did not meet the standards set up by the division, so they nullified the standards." "I personally do not use or prescribe new drugs/vaccines unless they have been on the market 2 to 3 years(Though I don't work with cancer, AID's, etc.)."

To: BigKNY3 who wrote (18979)	2/22/1999 2:03:00 AM
From: VLAD	Respond to of 23519

Relying on post-Marketing Studies for Approval "We don't trust that the companies will carry out Phase IV studies with due diligence, either before or after PDUFA." "Post marketing studies are frequently not completed. FDA has no power to ensure such commitments. Drugs have been approved before post marketing protocols have been reviewed." "Good idea but no way to enforce Phase IV studies. If sponsors don't do them correctly, what recourse does the FDA have? It's tough to pull a drug." (Kahuna, this is like letting the fox guard the chicken coup!) "The agency forfeits its most powerful weapon--withholding approval. Essentially all Phase IV studies which are required are for safety reasons. IF A PROBLEM IS IDENTIFIED, THE AGENCY NEGOTIATES WITH THE COMPANY FOR LABEL CHANGES. WITHDRAWEL IS EXTREMELY UNLIKELY EVEN IF THE PROBLEM IS VERY SERIOUS." "Post marketing surveillence done by the sponsor is inadequate as is post marketing surveillence at the FDA--this is one area of the agency that could really be improved." "There is no teeth in post marketing agreements." "I think all the drugs should have a large randomized safety study at approval focusing on DEATH AND SERIOUS EVENTS OCCURANCE." "Post-marketing is often necessary to examine aspects of a drug that seem safe and effective and should become available for use but may have not had adequate testing. All drugs can have more serious events that may not be revealed in clinical trials." Kahuna--I am but 1/2 way done--more later tonight.......VLAD

To: BigKNY3 who wrote (18979)	2/22/1999 8:47:00 PM
From: VLAD	Respond to of 23519

Kahuna, As promised I will try to wrap up my review of some of the important points made by FDA Medical Advisors in the PC survey. Don't forget that these Medical Advisors are on the front lines of giving good scientific review/input as to what medications have undergone sufficient testing/scrutiny to be considered safe for the consuming public..... Inappropriate Use of "Accelerated Approval" Category "The industry is more and more aggressive to get their NDA designated for 'priority review'. We have to fend off those inappropriate ones with considerable resources." "This is a formula for disaster. The patient doesn't benefit. A prime example is Fosamax touted as a 'gold standard' yet of questionable value. Another is tamoxifen for 'prevention' of breast cancer, but not yet fully available. Still another--VIAGRA. [Did you read that Kahuna? Yes, that's right, THE FDA's OWN MEDICAL ADVISORS THOUGHT THAT THE FAST TRACK APPROVAL OF VIAGRA WAS WRONG AND IS A FORMULA FOR DISASTER. Too bad that about 200 deaths and almost a year later and we only have one vague label change on Viagra. Again, this is due to big pharma money influencing the way the FDA makes its decisions regarding fast track approval of drugs.] "It is particularly in the case of drugs with new mechanisms of action that unanticipated safety problems are likely to occur. These are drugs that should not be subjected to accelerated approval." "I think it is abused by companies for marketing reasons, when benefit to the public health (or some small subset) will be minimal at best." "Should be reserved for life threatening or incapacitating conditions for which there are no other treatments."

To: BigKNY3 who wrote (18979)	2/22/1999 10:35:00 PM
From: VLAD	Respond to of 23519

Inappropriate Pressure on Medical Officers "My feeling after more than 20 years at the FDA is that unless drugs can not be shown to 'kill patients' outright then they will be approved with revised labeling and box warning." [Sound familiar Kahuna?] "I have heard of on Medical Officer who is said to have quit BECAUSE OF PRESSURE FROM CAPITAL HILL ABOUT A CONTROVERSIAL DRUG." [Boy Kahuna, what drug do you think that might have been?] "The Advisory Committee (or anybody) don't pay too much attention to what the primary reviewers say." "I was 'guilty' of expressing my opinions before the Advisory Committee of our Division and several others when I wrote consulting revues before 1995. I have not been asked to review since." "The default appears to be 'yes' [to approval]; the hurdle to disapprove a drug is much higher than approving a drug."

To: BigKNY3 who wrote (18979)	2/22/1999 10:51:00 PM
From: VLAD	Read Replies (2) \| Respond to of 23519

Medical Officer's remark on the issue of being pressured by supervisors included the following: "My office director told me that he was going to overrule me because the sponsor (Wyeth-Ayerst) would just go over our heads to Capitol Hill. He felt it was best to approve the drug for an indication not studied and have sponsors do a phase IV post marketing trial in support of the indication. I reminded him that the sponsor had failed to honor other Phase IVs. He went ahead and approved the drug." "Our supervisors didn't put pressure on us. They just ignore our opinion and write their own memo."

To: BigKNY3 who wrote (18979)	2/23/1999 2:57:00 AM
From: VLAD	Respond to of 23519

Kahuna, One other article I thought I might have you review again: usnews.com I'm sure you remember that one. Are those authors in some type of conspiracy with the PC to make up a bunch of lies regarding the way things work with the higher ups at the FDA? A politician just needs to pick up his phone and call a higher up after getting a protest call from Pfizer who so generously contributed to his campaign. The FDA Supervisor then simply overlooks the important scientific facts that are supposed to be the basis for decisions and ignores the Medical Advisor's opinions. It's called playing the game at the top of the FDA so that you continue to have job security. So what if a couple hundred guys croak from Viagra? At least they died with a smile on their face!