http://www.healthbeatblog.org/2008/02/the-wall-street.html
February 21, 2008
The Wall Street Journal Is Wrong on Avastin
......But focusing only on progression-free survival, i.e. how long a patient can go without a disease getting worse, is no better. As The Moss Report, an online cancer newsletter, notes, progression-free survival means that “a drug may change the shape of the patients' survival curve, but not alter the ultimate outcome. Treated patients may die on average at the same time as those who were not treated; sometimes they may even die sooner.”
In this case, we know that, any additional time comes with significant side-effects. In other words, the FDA’s stance is not just a question of time, but of quality.
Indeed, progression-free survival has the potential to be more devastating than standard deterioration. Imagine if, after two months of cancer stabilization, your loved one died at the same time as another patient who had been in worse shape for longer—that would be quite a blow.
The Moss Report points out that “patients who believe their disease is being controlled can feel an even greater sense of loss and disappointment when the disease again progresses than do those without any illusions about being cured of the disease.” Often abruptly dashed hope is more painful than a longer process, because the latter gives us time to prepare and come to grips with loss. If the Journal really wanted to think holistically about survival and benefits, it would be arguing against FDA approval of Avastin—not for it.
Yet the paper says that the FDA’s reluctance is symptomatic of an obstructionist “bureaucratic culture” bulwarked by “political pressure from Congress, where Members know they can always get headlines by calling for a crackdown on Big Pharma or exploiting public safety anxieties.” This isn’t fair. If we really want to make sure we maximize the benefits of medical science, we need to think hard about the incentives of drug companies—not just those of public officials.
The basic logic of the pharmaceutical industry is as follows: (1) a manufacturer creates a drug and runs trials, showing that it confers some benefit, either large or small. (2) The drug is approved by the FDA for a given use, and eventually for a wider array of conditions so that (3) use of the drug can proliferate across patient populations—thus allowing market share to grow. This leads to (4) increased profit, which leads to (5) nice, shiny Porsches.
These steps—or at least, one through four—make up the fundamental business model of prescription drug companies. All the cost is concentrated in steps one and two—research, development, and haggling with the FDA to get to market. To maximize profit, drug companies want to cut these costs as much as possible.
Now, if the FDA concedes that progression-free survival is enough to warrant approval, it essentially sets the bar very low for these early stages. The message is that manufacturers should go for the low-hanging fruit and focus on maximizing the number of ways to apply existing medications—rather than developing truly innovative new ones. The standard of proof is lower—so why not try and push through existing products, rather than incurring the costs of ground-up development?
No business in its right mind would say “no” to this opportunity. Already, drug companies spend more on promotion than on R & D because the effort is less and the financial reward is at least as promising—if not more so—than that attached to development. "Of course, because it is so easy to develop cancer drugs. I am sure Maggie is already planning her foray into the field. After all, with the bar so low, how could she not...
Speaking of low bars... Why did Provenge developer Dendreon and prostate cancer patients had to wait another 3 years for the FDA to approve the product?
And why do most developers of cancer drugs lose money? And as for companies spending more on "promotion" than on R&D, it is a tribute to Mahar's ability to even get the small things wrong: Drug companies spend 20 percent of their sales on R&D and, according to the CBO, devote 10 percent to promotion. Last time I checked that's less.
In any event, here's her 'reasoning' for being against drugs like Provenge and Avastin:
"Are you comfortable with the idea that the extra few months would be available to the wealthy, but not to the rest of us?
Also, if the patient has to pay for the very expensive drug that provides only a minimal benefit, there will be too few customers for the drug, and probably the drug company would stop
manufacturing it.
The only way that drugs like this stay on the market is if taxpayers (who pay more than half of all health care bills) continue to pay extremely high prices for drugs that provide a very small benefit."
On the one hand she writes -- in the very same post -- No business in its right mind would say “no” to this opportunity. Already, drug companies spend more on promotion than on R & D because the effort is less and the financial reward is at least as promising—if not more so—than that attached to development. "
But on the other hand, since the drug really doesn't work -- except for a few -- the company will stop producing it, except if the government also covers the medicine for people who are less well off?
Should new drugs not be made available because they are expensive and only benefit a few people? Is she against every orphan drug?
And here are Maggie's warm wishes for those now able to finally access Provenge
