Last week, the U.S. Supreme Court declined to hear an appeal of another court’s rejection of the suit brought by The Abigail Alliance for Better Access to Developmental Drugs. We hope that legal defeat allows Abigail to rest. With any luck, the Supreme Court has slowed a quixotic and ill-informed quest that began in 2003 with a lawsuit against the FDA. Blogs generally love the Abigail Alliance. We don’t.
The Abigail Alliance became a mini-movement, a cause. It was a channel through which the FDA could be hammered. Its main objective: allowing terminally ill patients to receive drugs that had not been approved by the FDA. Citing the dire situation of such patients, the Abigail Alliance sought to expand access to drugs even before they had been proved safe or effective in clinical trials.
We’d like to write the obituary of the Abigail Alliance, but that would be premature. It continues to raise funds and attract media attention. Which is surprising. Its agenda is radical. To quote the Alliance’s website, referring to terminally ill patients, the organization supports legislation that “bans the use of placebo and no-treatment arms on trials affecting this vulnerable population. This provision would force the research community and HHS to accelerate the woeful progress in defining modern data collection methods, including electronic health records and tumor registries.”
There is no getting around the poignancy of an individual cancer patient like Abigail Burroughs, for which the Alliance was named by her father, Frank. We have sympathy for the Burroughs family. We have also lost people to cancer, like many other families. But the hard truth is that nothing the Burroughs family has done will help other cancer patients. It has done the opposite. Muddying the waters, fanning hopes and demands for unproven drugs, is counterproductive in the extreme.
Indeed, we are dismayed that the Abigail Alliance got as far as it did. Its prominence is a reflection of pervasive U.S. ignorance about science in general and clinical trials in particular.
Fixing the clinical trial system might be a good idea. The process could be improved, God knows. Electronic records would help. Registries are a great idea. But the core of what the Abigail Alliance proposed was voodoo. It boiled down to just giving people drugs. This is not a “reform” of the research system or the FDA. It’s ridiculous.
At the risk of stating the obvious, there is already a measure of skepticism (among the public and the medical community) about data that have been rigorously scrutinized by the FDA and well-trained biostatisticians. Putting unproven compounds in the local pharmacy would have been extremely damaging to the industry over the long term.
Beyond that, on a practical level, the Abigail Alliance would create impossible challenges just to manufacture experimental medicines, let alone pay for them. And it would have trashed an already challenging environment for patient recruitment. If you or your loved one could get a drug without enrolling in a clinical trial, after all, why bother participating in research?
The lessons of the Abigail Alliance are ominous. The debate about pharmaceutical products and research is being driven by emotion and ignorance. Emotion and ignorance still pose considerable threats to the life sciences that are not being energetically addressed by any company.
The fact that the Alliance was able to attract political support in Congress is not surprising. Politicians will support almost any idea if it can be incorporated into a serious-sounding press release. Indeed, the whole point of getting elected to Congress, as far as we can tell, is to make an endless series of speeches about issues which the speaker only dimly understands.
But the editorial page of the Wall Street Journal also signed onto the Abigail agenda. Last year on that page, an Abigail Alliance co-founder, Steven Walker, was allowed to proclaim the “all too common, aggressive incompetence of the FDA’s cancer-drug division.” Is it really that bad? No. Has there ever been a better time to have cancer? No. Could the Abigail Alliance cure anyone’s cancer? Hardly.
We’re left with a massive, glaring gap between what the industry understands about the difficulty of clinical research—and what the public understands. Explaining the scientific process is hard. Explaining the clinical trial is more difficult. Most difficult of all is helping the public to understand the more thorny statistical and experimental design issues of cancer or HIV or other therapeutic areas where patients are near the ends of their lives.
That, of course, is precisely where the best science is most needed. That is where the best minds are drawn. And that is where the bets which are the most sizable, the most risky, must be placed. Understanding such matters remains challenging for society. The existing system, linking academia and industry, combining private investment and public review, is not perfect. But it is making headway against cancer and other diseases.
Sadly, the explanation of what the industry does is not going as well as the science itself. The U.S. schools will not do it. Media coverage will always be driven by syrupy fables like those of Abigail Burroughs or Lance Armstrong. The math, the numbers, the rules, the scope, the protracted duration of the quest—none of it is sufficiently appreciated in a complaint-oriented society.
Like it or not, the challenge of explaining drug development must land on the industry’s shoulders. Explaining how the research process works should be high on the to-do list of every company in the life sciences. Without more effort in that direction, there will be more fringe movements like the Abigail Alliance. And science, industry and society will suffer.d9A2t49mkex