The Drug Doesn't Work, So Big Pharma Changes the Rules!
For all the lack of safety in too many prescription drugs, new drugs do have to go through a lot of testing before they hit the market. They're often tested in animals first, and once they come out of the lab they must go through three phases of clinical trials.
Phase I trials are the first safety tests. They usually involve only a few people. They're intended to gauge whether the drug is safe at all, to find a safe dosage, and to identify side effects. Many drugs never get past this phase.
If researchers do decide a drug is safe enough to test in a large group of people, it goes on to Phase II trials. This stage looks at whether a drug is actually effective, and whether it still appears safe when given to more people. Many more drugs fail here, but if they seem to work they go on to Phase III trials.
Phase III trials expand the number of people taking the drug and fine-tune the dosage. They take another look at effectiveness, usually compared to a placebo but sometimes compared to other similar drugs. If a drug makes it through Phase III trials, it then goes to the FDA for approval. So what happens when your drug repeatedly fails at Phase II or Phase III? If you're Eli Lilly & Co. and you have a new Alzheimer's drug you want to sell, you just change your definition of "effective."
If at first you don't succeed, try and try again. And again. And again
Last year there was a lot of buzz about an Alzheimer's drug called solanezumab that's been in the works since the early 2000s. The pharmaceutical world was excited. Wall Street was salivating and Lilly stock prices showed it. Predictions were that this drug would be a "game-changer." News stories sang its praises and raised the hopes of those dealing with early Alzheimer's.
Solanezumab looked great in mice. And the way it worked stood the current thinking about what actually causes Alzheimer's on its head — a fact which has since been forgotten. Conventional wisdom says that Alzheimer's symptoms are caused primarily by the buildup of beta-amyloid plaques in the brain. The thinking goes that these plaques interfere with the neurons' ability to network, cutting them off from each other and eventually leading to neuron death.
Solanezumab worked not by affecting the plaques, but by clearing beta-amyloid circulating in the blood instead. And it did work. It appeared to be a miracle drug. It reversed the memory loss caused by Alzheimer's and restored the little critters to normal.
Unfortunately, the drug was a bust when it was tested in people. It fell flat in Phase II trials. It was no better than a placebo. But undaunted, Eli Lilly & Co. moved the failure on to Phase III trials.
When billions are at stake, Big Pharma just changes the rules
Current FDA rules say that Alzheimer's drugs must "demonstrate effectiveness in both cognitive tests and functional measures." That is, they have to show an effect both on memory and thinking and on the ability to perform everyday tasks. These were the goals — the "endpoints" of the Phase II and III trials.
But the drug failed to meet these endpoints in Phase II trials. The drug which had shown such miraculous results in mice was a dismal failure in humans. Lilly & Co. were in a panic. They could see billions of dollars in profits melting away before their eyes. When the Phase III trials had the same result, they started grasping at straws.
They went over all the data with a fine-tooth comb and in the end they found a tiny, statistically insignificant improvement in cognitive function. They had to pool all the trial data together to find it and it only applied to a tiny subgroup of people. There was no difference at all in functional abilities. So they ran a second trial, with the same result.
You would think that after three failed trials and several thousand participants, the drug would be abandoned. Far from it. The lure of billions in profit outweighs all.
After three humiliating flops, the drug has gone into yet another Phase III trial — long after most other drugs would be abandoned. They really, really want this drug to be approved, and this time they want to change the rules. This time, they only want to use cognitive function as an endpoint. They're hoping that by changing the rules and getting rid of one endpoint, and by expanding the number of people taking the drug yet again, they can turn that statistically insignificant effect into a selling point for FDA approval.
After all, it worked for Addyi, the "female little blue pill," right?
"We're not cheating. We're just 'making adjustments'"
Big Pharma apologists are quick to say this last-ditch effort to show the drug does something isn't…well, a last-ditch effort to show that it does something. They point to "new evidence" — which isn't new at all — showing that cognitive decline comes before loss of functional ability. Whose leg they think they're pulling I'm not sure, because this is far from breaking news. Nevertheless, they've changed the rules. It remains to be seen if the FDA will break their own rules and approve it anyway.
I know where my I'm placing my bet. Solanezumab will finish its last Phase III trial this fall. Soon after, we'll see it approved. It will offer a nearly imperceptible benefit for those in the very early or even "pre-clinical" stages of Alzheimer's, but thanks to top-notch marketing departments, it will be hailed as a miracle drug.
And it will set the stage for the next cheater who wants to break the rules just so they can pick our pockets.
What can you do? Probably nothing. But forewarned is forearmed, and knowing what a complete failure this drug has been and the shady dealings that have gone on behind the scenes may save you from expense and heartache at some later date when it's been approved. And you could contact the FDA.
After all, it worked for Addyi.
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