hands, as FDA regulations tend to be more stringent than those used elsewhere.
Reimbursement rates for the latter jumped dramatically in 2000. Those developments enabled the firm to raise $130 million by selling new shares, and in the past year its stock price has jumped 430%. Some companies fade into oblivion when the markets they play in wane. Kudos to Advanced Magnetics for reinventing itself and searching for new markets.
Conditions of approval include creation of a patient registry and restriction of its use to patients who meet the eligibility criteria as defined in the clinical trial.
Nonetheless, its shares plunged on the news, reports the New York Times and Bloomberg News. The trial was conducted without patients giving their informed consent, as they were too traumatized to do so. That protocol has caused much controversy and last week an FDA panel recommended against allowing Biopure (Cambridge, MA), a Northfield competitor, to conduct a similar trial. Today, Biopure asked FDA to approve a scaled-back version of the trial, reports Bloomberg. One has to wonder whether development of these products is hitting a dead end.
So FDA gave the doctor clearance to use the excimer laser system developed by Elana (Utrecht, The Netherlands), which is not approved in the United States but has been used in Europe. The laser allows the doctor to not have to first cut a hole in the brain artery and then sew a vein to it. That would require the clamping that is too risky in this case. Instead, he can sew first and cut later, using the excimer laser to make the hole later. The operation was successful. Kudos to FDA for allowing an experimental treatment when all other options were too risky.
The release on Biomet's site states that former CEO Dane Miller, who resigned from his post in March, could also become an investor in the private company. The buyout is expected to be completed by October 31 of next year, upon which Biomet's stock will be de-listed. The company's interim president, Daniel Hann, said in a statement that becoming a private company will put Biomet in a stronger position.
What needs to be done is to have the device shut off, or to disable it with a magnet in an emergency. But often during the course of one's last days, patients, families, and caregivers may forget the ICD is present. Some patients and families don't want to authorize turning off an ICD, because that's an admission that death is imminent and inevitable. And some doctors believe turning off the ICD could be an ethical violation. The solution is not to cut back on implanting the devices (as some in the article suggest), but to keep this issue at the forefront of everyone's mind when planning for a patient's passing on. That may take some re-education, but it will be worth it.
The Star Ledger reports that although a quality assurance board recommended a recall, Lippman claims nothing happened. He said another executive at the company wanted to "soften" the board's evaluation in order to justify a smaller recall. In May, Lippman was asked to resign for reasons not mentioned in the suit. Another device Lippman raised flags about was the contraceptive skin patch, Ortho Evra. The patch has triggered more than 1,000 product liability suits that allege the device causes a higher risk of blood clots and strokes. J&J said that Lippman's claims are false.
