John,
You have every right to be confused about what's happening. The situation is as clear as mud. First let me state that discussing the validity of the science is outside my area of expertise. Hank and Rick C. know much more about the science than I do and Hank has showed some scepticism. I am looking at how some of the players are behaving and guessing that the science is good. Let's look at a few facts and suppositions and see what we can make of them.
This is from the Dec 12th press release about the Bastyr study:
A very slight increase in two liver enzymes, AST and ALT was observed in two subjects, which may indicate lower tolerance for the herb in some individuals. Thirteen of the initial sixteen subjects
completed the study. Of the three participants that withdrew, two experienced a bitter taste and the third displayed severe allergic hypersensitivity.
1) I believe that when Babish talked about the AndroVir release at the Smith Barney conference last February, he proposed selling AndroVir in doses that were either 1/2 or 1/3 as strong as that of the AndroVir study. These weaker doses may be less effective against the virus, but they would be less likely to have harmful side effects.
2)I believe, that the severe allergic hypersensitivity referred to was a rash and that this disappeared when the patient stopped taking AndroVir. I could be wrong on this point, but that was my impression. I don't remember where I got it from and I might be thinking about the reaction from the AndroCar compassionate use study and not the AndroVir study. If I am correct that the main adverse reaction is a rash that will go away when the user stops taking AndroVir, then it will be a simple matter to add a label to the AndroVir saying "discontinue use if rash develops."
3) What have the main players done? Babish sold stock. As Rick D. points out, we can't be sure of the real reason why, though it seems that at least part of the reason was to raise money for Babish's son's tuition and to get the Board's attention in negotiations. If I remember correctly, Hank got an e-mail from Babish a few months ago in which he stated he wanted to see a stockholders meeting and that he still has confidence in the science. Hank, is my recollection correct? Assuming it is, then you can't tell too much one way or the other about how good the science is by the way Babish is acting.
4) Colin Campbell is still holding all his stock as far as I can tell. I don't remember seeing anything to indicate that he sold, and according to Rick C.'s story, he probably still has his stock. Furthermore, he has gone to the trouble and expense of hiring lawyers to sue the company. In the April 4th press release that he issued when he resigned from the Board, Campbell said:
"As a significant shareholder in Paracelsian, I believe I can be of greater assistance to the company at this time in a role other than that of director," said Campbell. "I remain convinced that the marriage of Paracelsian's biotechnology with natural products derived from extracts of herbs used in Traditional Chinese Medicine presents an exciting prospect for the application of botanical extracts to healthcare."
Now we know what he meant by his cryptic remark that he could serve the company best in a role other than that of a director. He meant that he could best serve the company by suing it to remove the current management. As a large stockholder, he presumably wants to do more than just get rid of current management. He'd probably also do what he could to get better management to get this company back on its feet. One could make a strong argument that Babish would have to cling to the belief that the science was sound. After all, the science is his baby and he can't admit it was flawed without doing serious damage to his credibility and his career. Colin Campbell is not in the same position. Though he is in a position to understand the science, the science is not his baby and if he thought it was flawed it would not be as psychologically difficult for him to admit it as it would be for Babish. He is investing a lot of money in a lawsuit to throw the rascals out. He is certainly behaving as though he believes in the science and that there is something in this company worth saving.
5) The people who have questioned the validity of the science are Rhodes and the Board members. . . the same people who have given us the great Ah Immunoassay giveaway. I don't have any idea what the Board's motives really are, but they certainly have been acting like they have a death wish for the company. I'm not sure how competent the board members are in judging the safety of AndroVir or if they have any hidden motives for killing its release.
6) Hank mentioned that kinases are usually not specific and are therefor toxic. I am no expert on this, but he sounds like he knows what he is talking about. So there is a theoretical reason to have doubts about AndroVir. On the other hand, the Chinese have been using the herb from which it was extracted for hundreds or thousands of years, so there is a theoretical reason to believe it is not that dangerous.
7) The FDA never said that the company couldn't sell AndroVir because it was worried about its safety. If the FDA had concerns about AndroVir's safety, the logical thing for them to do would be to say it could be used by no one, or else it could be used by ONLY AIDS patients. AIDS patients have less to lose and more to potentially gain than someone in the general population. There would be no point to exposing someone to this dangerous product if there was no posibility that the product's potential benefits outweighed the potential risks. If the FDA had serious reservations about AndroVir's safety, why didn't they ban it? Why did they insist that if it were released, it should only be released to the general populaion?
Of course, I realize that saying the FDA did not ban AndroVir does not mean they approved it. They did not give their seal of approval by any means, and even if they did, if people have adverse reactions to AndroVir they could still sue the company. Still, the FDA saw the data and it did not set off alarms loud enough for them to ban it. They said the company could sell it to the general market.
To sum up, it appears to be Babish's and Campbell's word that AndroVir is safe against the word of Rhodes and the Board, and the FDA is not stepping in to stop AndroVir's launch for safety reasons. You also have theoretical reasons to believe it is safe as well as reasons to believe it might not be. So it's up to you, John, to decide whether AndroVir is really safe. I've weighed the evidence and I believe it probably is safe. But I am no expert and I could be wrong. The only cliam that I am willing to make is that I have predicted things in the past about this company that have turned out to be wrong, and if I keep making predictions in the future, some of them are bound to be wrong.
Robin M. |
