Merck backs down

[Aelia Jusa]

Originally posted by robertthebard: My question remains, however. Just because the injected group didn't develop cancerous cells doesn't mean they would have with out the vaccine.

The presence of the control group shows that the vaccine was the reason the vaccinated group did not get cancer. As long as the participants were randomly assigned to the control and vaccine group, then the only difference between the groups is the vaccine. Random assignment ensures that every other thing that may differ between the groups is equal across the groups - i.e. both groups have equal likelihood of developing cervical cancer without the vaccine. This will be particularly true because of the huge size of the groups. So two groups which are otherwise equal in every respect, one group gets the drug and one doesn't (or gets a placebo), therefore any differences post-test must be attributable to the drug. This is how scientific testing works.

[robertthebard]

So by this test, they can, in spite of the fact that not all of the other 1/2 of the test subjects developed the cancer, say that the only reason those women didn't get cancer was because of the vaccine? It seems to me that the number of women who did get the cells for cancer would have had to be a lot higher to take into account the fact that not all women get cervical cancer. To me, it seems a bit misleading to say that the only reason those women didn't get the cancer was because they were vaccinated. Maybe it works, maybe not, I don't know, but I don't think that one real study constitutes proof. How many studies did they do with Viox to prove it was safe, only to wind up in court because it wasn't? You'll notice, in the linked article, that stock prices went up after they released the study results.

[Garnet FalconDance]

I think what Robert's trying to get out is this: regardless of there being a control group and both groups equally apt to develop cancer, there really is no way of saying that without the vaccine the group that tested clean wouldn't have done so anyhow.

Cancer is a mutation of the body's own cells gone rogue - there may be genetic predilictions and environmental triggers, but in the end, the body either will or won't run rogue. All the predictions in the world cannot accurately say if a person will definitely develop cancer.

For example, I am considered at high risk for cervical cancer since my paternal grandmother died of it at 39 (she knew she had it at age 28). I dreaded pap smear results, especially at those ages. Apparently whatever genetic trigger I may carry is turned off as it is off for both my sisters so far. That's not to say I'm completely in the clear, of course, but there is NO sign medically.

So it may be that the women who did not develop cancer simply wouldn't have anyhow, regardless of having been vaccinated. Short of physically manipulating their cells to deliberately introduce cancer, there is no way a doctor can say with certainty that the vaccine prevented it. That is one of my main objections/concerns with this vaccine.

It appears the vaccine prevents a certain kind of cancer because it protects against a certain contributing factor. In my opinion, it is shoddy practice to say (as has been advertised) that cervical cancer can be prevented because there's a drug that may prevent one of the contributing factors that may leave a woman highly susceptible to those cancerous mutations.

Is it hopeful? Yes. Is it safe? Don't know. Does it really work? No way of knowing with certainty that it does without deliberate manipulation on the cellular level, in my opinion. And that sort of testing on humans is not acceptable.

[Aelia Jusa]

Originally posted by robertthebard: So by this test, they can, in spite of the fact that not all of the other 1/2 of the test subjects developed the cancer, say that the only reason those women didn't get cancer was because of the vaccine? It seems to me that the number of women who did get the cells for cancer would have had to be a lot higher to take into account the fact that not all women get cervical cancer. To me, it seems a bit misleading to say that the only reason those women didn't get the cancer was because they were vaccinated. Maybe it works, maybe not, I don't know, but I don't think that one real study constitutes proof. How many studies did they do with Viox to prove it was safe, only to wind up in court because it wasn't? You'll notice, in the linked article, that stock prices went up after they released the study results.

Well, whether it is safe and whether it does the thing it is meant to are two different questions. Tests for Viox would have showed that it did the thing it was supposed to (sorry but I can't recall what it was for - arthritis?) but were clearly not sufficient to demonstrate long term side effects. Similarly the tests for this vaccine are aiming to demonstrate that it prevents cervical cancer by immunising against HPV. Not necessarily that it is safe in other respects.

If a large number of the control subjects developed cervical cancer then that would indicate that there was clearly something screwy with the way they recruited participants. The risk of developing cervical cancer is very low overall. So the small number of women developing the cancer in the control group would be representative of the population risk of cervical cancer. The point was not to show that lots of women get cervical cancer when they DON'T get vaccinated, but that no (or at least many fewer) women get it when they DO get the vaccine. Which was shown.

They have two very large groups which are essentially identical in every way - general health, age, risk of cancer, etc. This is achieved through random assignment to control and vaccine groups. Therefore you can assume that since everything else is equal, if neither of the groups had been given the vaccine then after a period of time there would be equal numbers of women from both groups developing cervical cancer - we can be confident in assuming this because the groups are the same in every significant way. So then if one group is given the vaccine, and the other isn't, and the control group has a significant number of women developing cancer and the vaccine group has no one with cancer then the likelihood of this result occurring purely by chance, i.e. it would have happened without the vaccine, is very low. Much lower than the likelihood of the result occurring because of the vaccine. Statistical analyses would have been run in this test to determine the probability of this result occurring by chance. For a result to be considered significant in studies like these, the probability of the result being due to chance not the vaccine would be extremely low (e.g., 1% or lower).

Of course, support for a result in a study like this is much stronger when it has been replicated in other studies. Although I think Bungleau indicated that a number of studies have been conducted showing the same pattern of results, not just one. However, provided that the methodology in this study was sufficiently rigorous (i.e. proper random assignment, appropriate pre-tests, etc.) then this result is very strong on its own. This is how all drug trials are conducted. It is definitely possible to be wary of this vaccine because there have not been sufficient studies to demonstrate possible long term side effects, or whether the effect lasts over a person's lifetime. However, you should not be wary of whether the drug does what it supposed to do, i.e. prevent HPV and therefore cervical cancer, because the tests have shown that it does.

[robertthebard]

I just feel, as I stated before, that stating 100% effectiveness is misleading, since, as you stated Aelia, not every woman will get the cancer. It's effective is probably quite evident, I just don't like the assumptions made.

[Bungleau]

Interestingly, this made the local papers here, primarily because of the pricing disparity. At local universities, the price for the three shots ranges from $375 to $546...

*SOMEONE* is getting a nice markup... and I suspect now that the rates at the different universities are published, there will be some shifting in the price.

[Garnet FalconDance]

Something I hadn't thought of and I don't believe has ever been brought up in any of the discussions I've been in about this vaccine (if it has here, I apologize):

If this protects against a primarilly sexually transmitted set of virii which then may result in cervical cancer in women, why not vaccine MEN as well? Seems to me that if the other half of the equation were also protected against the virii, the entire problem would be alleviated to a great extent.

[lethoso]

Originally posted by Garnet FalconDance: Something I hadn't thought of and I don't believe has ever been brought up in any of the discussions I've been in about this vaccine (if it has here, I apologize): If this protects against a primarilly sexually transmitted set of virii which then may result in cervical cancer in women, why not vaccine MEN as well? Seems to me that if the other half of the equation were also protected against the virii, the entire problem would be alleviated to a great extent.

There's little point to doing so. Men can't get cervical cancer, so there is no advantage to men getting it. The only benefit to vaccinating men would be somewhat improved protection of those women who have refused the vaccine. I don't know about you, but I can see a much cheaper (and more effective) way of protecting these women than vaccinating the other half of the population.

[Garnet FalconDance]

Agreed. BUT (and I'll do some research) does HPV only mutate to cervical cancer or is that all the drug company has been looking at it? Are there no known health risks for men? Has anyone researched it? If not, then why did the connection to HPV and cervical cancer pop up exclusively?

If HPV is a primarilly sexually transmitted virus - and sorry Lethosos, that means that MEN have it and transmit it - then vaccinating MEN as well makes a LOT of sense. If you can eliminate some of the carriers, then many of the end-case scenarios cease, as well.

Don't mind me. I'm a curious cynic. I want answers - and both Big Business and government are loathe to provide answers unless it serves their purpose.