We've discussed the scandal over the use of Avastin and Lucentis for wet macular degeneration several times (here, here, here). If you've missed it, here's the gist. Avastin is a drug approved to treat colon cancer. It works by choking off blood vessels to the tumor. It turns out, however, that a tiny dose of the same drug, when injected into the eye can also stop the uncontrolled growth of blood vessels behind the retina that produces a leading cause of blindness in the elderly, macular degeneration. The good news is a compounding pharmacy can take the large dose in the Avastin package and split it into sterile eyeball-appropriate doses. The cost is somewhere between $20 and $100. That's good news for consumers, anyway. It wasn't such good news for Genentech, the maker of Avastin. So they went about making a small modification of the drug, renamed it Lucentis, and got FDA approval for its use in macular degeneration -- at $2000 per monthly injection. Avastin is not approved for the same purpose because Genentech has not applied for approval. It's still legal to use it off label, however, and numerous ophthalmologists have been doing so to save their patients and the taxpayers' money.
Genentech was not amused. So they announced in October they would no longer sell Avastin to compounding pharmacists. There was an immediate and vigorous reaction from doctors (good for them!). Now the New York Times has reported the two sides have reached a compromise, of sorts:
But Genentech and two associations for eye doctors announced that doctors would be able to order Avastin themselves but have the drug delivered to compounding pharmacies.
That would allow access to the drug, but would allow Genentech to stop selling the drug to compounding pharmacies. The company said the sales to the pharmacies had provoked concerns at the Food and Drug Administration because Avastin is not made for use in the eye.
In an e-mail message sent to their members on Thursday, the American Academy of Ophthalmology and the American Society of Retina Specialists said they believed the plan "addressed the needs of most of their members." However, regulations vary by state, the groups said. (New York Times)
This arrangement forces an extra step for the doctor, the patient and the pharmacy. It is unnecessary but better than the alternative, as long as this arrangement lasts. Look for Genentech to try again to shut off the supply of Avastin for macular degeneration.
Big Pharma is not about saving lives or vision. It's about making money. Merry Christmas.
I won't comment on the post except to say that there is obviously no limit to the greed and amorality of pharmaceutical manufacturers. These people are outside of the civilized community.
But, I haven't commented here for a while, so consider this my holiday card. We've been through a lot of tough times these past few years, next year probably won't be a whole lot better, but then I believe the ice will melt. Happy holidays contemplating a more hopeful future.
Revere: Big Pharma is not about saving lives or vision. It's about making money.
If we assume the statement above is the reality, then something that we can think to work with.
We need to live with creative tension as Peter Senge's advice in his The Fifth Discipline; meaning our creative energy is positive, even we have been frustrated by the reality that Big Pharma is short sighted.
Is Effect Measure in the right stance to facilitate a rating system ( independent appraisal ) to function as positive re-enforcement for Pharma industry starting with vaccine manufacturers? Is the motivation or/and professional expertise just enough to stretch? I don't know.
At least during approaching the new year, I would like to think forward a bit. My opinion.
Hey I agree with Revere. It IS about making money. It gets down to the thought once again as to whether healthcare is a service or a right. Cant have those indecent profits in a business, so lets convert it to a right. A legislated right, lets limit what these guys can make by the law. Lets tell them what they can make off of a drug that they spent the money to produce, then go thru the approvals process, then manufacture. Then when it goes wrong for a few... get sued over.
Public opinion swings the gate and they started feeling the heat in the marketplace and sure I think that 2000 bucks per is pretty stiff especially on people that like my mother had macular degeneration and my brother also is missing about 1/3rd of the vision in the right eye. But, in the same breathe those drugs were developed not with service in mind but to make a marketable product. For me, I would simply put it to them like this. Do you want to sell a LOT of this stuff or do you want to sell very little?
We all have the right not to pay or ask for it and I can assure you that the insurance companies played no small part in this. Got to have people who can see well enough to write checks and that go to work until they hit 65.
Cervantes- It is a Merry Xmas when we live in a place that is able to make these drugs and hasnt auto-destructed (yet) into socialism. I doubt this drug would be on the approved list in the UK because it costs too much. In addition to that, even if it were they would intentionally keep the price up because its their drug and not the governments and they negotiate for this stuff. But there is never enough money in the till so they keep on raising that rate so you can get your now very overpriced drug. Hey, it ENSURES you will pay more for it in a single payer system.
In addition to that, you can bet the drug would never be put up for approval for the use in eyes anyway. Why should they? It doesnt make economic sense. The plain fact of the matter is that people suggest this is bad and wrong in some way. For whom? Certainly not the stockholders who put up the money to form the companies that make all of the cool gizmo's and drugs that we have here. Its the affordability that bugs just about everyone. But is it a service or a right?
Revere I agree and think its pretty outlandish pricing... The market spoke, they listened and they are Big Pharma. They are a business and the insinuation that they are doing something wrong is more wrong. It is the big buck cash cows that lead to more innovation. The polio vax was one of the first big buck bug killers and the government got absolutely SOAKED for that and still does.
Eventually they will develop a cure for cancer and they will establish a price of say 100,000 dollars to get it. 15 minutes later someone will say that its outrageous to price it at that and that people will die if they dont get it. Then someone will try to take it from the company that made it. Now there's the crime IMO.
Randy: I don't think you are framing it correctly. I would say it somewhat differently: is public health a social good or a market good? There is still a fundamental difference in outlook, but I don't view it as an entitlement but as a social good (much as you view the "common defense") that benefits me when someone else has it.
Now thats the rub for sure Revere. I dont disagree with that statement at all. But this part is way over the head of many people. There are those that would simply take it by legislation or create a taking environment and that would doom research across the board to a very limited funding program. Government couldnt fund research because they will be busy with the all encompassing socialized medicine programs.
Certainly wouldnt be any funding from the Pharms if UHC was in place. No need for it. They would simply jack the price every contract term for the same drugs as they have in the UK. Got to make money for the stockholders and they would then have a captive market. The negotiators would simply turn to legislators and say, "We need more money, they wont sell us Avastin at that price."
Then unless someone is willing to jack boot it, they have to pay.
Very good point. Big pharma are "for profit" organizations.
So our problem is to calculate how to reframe the profit environment so as to shape big pharma's evolution to accord with "fifth discipline" insights.
Bar: Happy holidays! Don't work too hard in holidays :)
Peter Senge's idea is to look for leverage, therefore to use the leverage to change the system. His core discipline is the 5th- SYSTEM THINKING.
Here we constantly to review the topics of public health, perhaps if we can select one focus, the vaccine production. In general, vaccine is still under the frame work of Big pharma and her systems.
I am not much concerned with the profit issue, my bias? People is willing to pay higher price to buy excellent medicine, just like the doctors' incomes are in very top rank, sort of market combines with mythology reality. Anyway, profit is the by product of good performance.
Our concern is we need right medicine ( vaccine especially) in a right time at a right price, I mean for everyone.
So, where is our leverage as far as the team/blog of public health stakeholder is concerned?