The suit claims that FDA violates the due process rights of terminally-ill patients, who have exhausted all approved options and are unable to enter a clinical trial, by prohibiting access to promising investigational drugs.
Consider the plight of such patients. They search for clinical trials of new drugs that might extend their lives. Nearly all are ineligible. Of the few who do qualify, many learn the trial is fully enrolled and closed, or too far away. Others face a 50-50 chance of getting a placebo (a sugar pill) under blinded conditions (meaning neither they nor their doctors know what they are getting). Many are allowed to die without being told about or offered the active drug.
The FDA commonly insists on statistically comparing the timing and severity of the deaths of untreated (placebo) patients with those of patients who receive the potentially effective drug. This renders the FDA's vaunted "science" for drugs intended to treat terminal illnesses little more than a crude measurement of the height and accrual rate of two piles of bodies. There are better, less ethically challenged trial methods available to test drugs, but the FDA has consistently refused to accept them...
No matter one's judicial philosophy, it is inconceivable that the framers of the U.S. Constitution intended unelected, tenured career bureaucrats to hold absolute power over American lives without prospect of challenge in the courts. The framers understood that the pursuit of life is an inalienable right that should not be abridged without due process of law.
All right, so that was only part news, part opinion. Here, for your itching ears (aching eyes?), is a more newsy story. Gautam Naik (B4) writes on the creation of a stem-cell line (subscription required. No, it's not a *controversial* (destroys embryos) line, nor is it *uncontroversial* (iPSCs, from adult skin). It's a semi-controversial approach, that of taking one cell from an eight-cell-stage embryo and teasing it so that it becomes a line. Granted, according to Dr. Robert Lanza, it only has worked in about 2% of the cases (so much for payoff, then?), but at least it works and apparently has no risk of cancer (one of the worries about iPSCs).
The new technique is partly based on a common test done in fertility clinics, known as pre-implantation genetic diagnosis. Under this approach, one cell is removed for genetic testing once the embryo has reached the eight-cell stage. The process appears to leave the embryo intact. Embryos that have been subjected to the procedure and then implanted in the womb have yielded apparently healthy babies, based on established scientific and medical measures.
And, to bolster the news, "Lanza and his colleagues say they have tweaked the approach so that at least 20% yielded stem-cell lines, and further improvements took the efficiency as high as 50%." Much better. I'm waiting for improvements on this--it could very well be an excellent technique, as long as it doesn't kill the embryo. As the venerable Dr. Seuss once said, in the words of Horton the elephant, "A person's a person, no matter how small." (I'm looking forward to the movie, too!, something a I'll feel completely comfortable watching, prudish me.)