The amazing thing here that should not be overlooked, is that there is a group of researchers at Merck who actually discovered that a percentage of women in the world could possibly not have to suffer from a certain cancer if protected from HPV with this vaccine.

Researchers were led in that direction through the work of Nobel Prize winner, Harald zur Hausen…”Thanks to this research, we now have vaccines that prevent infection by these carcinogenic strains of HPV, which are responsible for around 70 percent of all cervical cancers and kill an estimated 175,000 women a year. (www.arstechnica.com)

There is a risk in all that we do; I feel that if I could protect my child from having HPV and pre-cancerous cells, as I do, then I will vaccinate my child and will be grateful to the folks who have spent their lives working on this amazing research.

In the meantime, there is the big issue of Hatch-Waxman abuse. And there is also the issue you raised initially, about what it means to be “fair” in judging the industry right now (whether it’s me judging or someone else).

I find that the most interesting, and challenging, question of all. I look forward to returning to it on another thread.

BTW, all of this the result of the tricks and tactics of those lawyers your always worrying about, but this time they’re working for the company, not pts.

I didn’t say less ocular allergy was not a benefit - obviously it is for those pts. But the ten times greater likelihood of failed efficacy would, in my book, outweigh that if one were looking at the whole picture a the product.

My main point, though, was about the way Americans have come to view drugs in general over the past few years. While I do not have a good study to demonstrate it, I believe it likely that there is as much heightend doubt out there about benefits as there is heightened anxiety about risks.

It’s that perception that was the point of my post. Again, not something a shareholder wants to know. Nor one who believes - as I do - that, for most approved drugs and for most pts, benefits do outweigh risks.

I’m not trying to be smug here, but if Allphagen the best you could come up with then I don’t think the industry has much to worry about in reguards to “all approved drugs having benefits”. This drug clearly has benifits (over placebo) — it just doesn’t have clear benefits over a generic.

2) Is 5% fewer allergic responses really a benefit? It depends on whether you are one of those 5% or not! If you’ve already been established on the drug with no allergy, then certainly there is no benefit. For new patients, however, it isn’t clear who will and who won’t be allergic. So a doctor will see ~33% fewer “adverse event” follow-up visits. Is that a benefit to the health-care system? It depends on how much the extra doctor’s office visits cost vrs. how much the added expense of the non-generic drug is. I don’t know the answer.

3) I couldn’t find any info on the lack of efficacy of the newer product. (but I couldn’t get access to the full text journal article either) This is what I was able to find: “The baseline intraocular pressure (IOP) was 24.4 ± 2.45 mmHg for brimonidine 0.2% and 24.39 ± 2.56 mmHg for brimonidine Purite 0.15% (P = 0.985). The IOP was at trough drug effect after 4 weeks of brimonidine 0.2% and brimonidine Purite 0.15% therapy were 20.10 ± 2.01 mmHg and 21.00 ± 1.67 mmHg (P = 0.001), respectively. The IOP at peak drug effect after 4 weeks of brimonidine 0.2% and brimonidine Purite 0.15% treatment were 18.10 ± 1.73 mmHg and 18.20 ± 1.71 mmHg (P = 0.518), respectively. Brimonidine 0.2% was found to cause more allergic conjunctivitis than brimonidine Purite 0.15% (P < 0.001).”

4) This is a strategy that is used all the time. Looks at Wyeth’s “new” antidepressant (Prestiq). Is it really an advancement? I say let the market decide. Same with this one.

When Alphagan (for ocular hypertension) went off patent, Allergan stopped selling it in the U.S. and substituted Alphagan P to keep market share. Alph P had 25% reduced active ingredient (brimonidine tartrate) and a different preservative which claimed to be less irritating to cornea (essentially no evidence for this claim). Major promo claim was that relative risk of ocular allergy was 33% less with P. In real numbers, that was 90 people of 100 not having allergy compared with 85.

In the meantime, relative risk of lack of efficacy (criteria defined by FDA and Allergan) with P compared with original formulation, no longer available in U.S., was 400%. That bit didn’t get into the promos.

Benfit? Progress? Honesty? Please also be specific.

Nathan - I am not anti-pharma. I’m a stockholder in three companies. I use rx drugs. I depend on rx drugs.

It may be that I am more “edgy” as preemption approaches - as I’ve often said, because of the disaster I believe it will bring to the industry as well as all of us. It’s also hard not to react to the seemingly endless stories of sleaze, but you may have noticed - in the Nemeroff story - my focus was on corruption in academia, my own bailiwick, not pharma. Takes (at least) two to tango.

Re: the comment about benefits, I was referring to the various polls we’ve seen and what I hear back from doc friends about increasing numbers of pts who don’t want to be on anything. These docs, at least, feel something has changed. And they certainly aren’t describing pts who are not aware of risks - almost too aware, from their perspective.

I haven’t been able to dig up any info on HPV. However, a close analogy is Prevnar. It is a pneumococcal vaccine for infants. It is similar to Gardasil in that it only protects against the most virulent strains of pneumococcas. (9 strains) One strain (19A) has become more prevelent since the introduction of Prevnar in 2000. However, it is FAR from being ineffective. The rate of meningitis in the US has fallen from ~25 cases per 100000 population to ~13 cases per 100000 population. The CDC estimates that the vaccine (now manditory I believe) has saved approximately 10,000 deaths and an additional 160,000 cases of infection. In responce to the increase in the 19A strain, two companies (Wyeth and Merck) have developed follow-up vaccines to additionally target the resurgent strain.

This is very similar to antibiotic resistance. The battle will never actually be “won”. We’ll always have to keep developing new antibiotics and new vaccines to deal with the ever-changing bacterial and viral threats.

Here’s the article about Prevnar that I got the above info from: http://online.wsj.com/article/SB122341849865912983.html?mod=googlenews_wsj