Larry Kessler, PhD, director of CDRH’s Office of Science and Engineering Laboratories, has assumed the chair of the Global Harmonization Task Force. His term will last 18 months. The GHTF consists of representatives of regulatory bodies and trade associations from the United States, Canada, the European Union, Australia, and Japan. Among other things, it issues harmonized guidances that promote the convergence of global regulatory practices. It will be interesting to see what happens with the chair in U.S. hands, as FDA regulations tend to be more stringent than those used elsewhere.
Today’s Boston Globe profiles Advanced Magnetics Inc. (Cambridge, MA), which, despite not much in the way of revenues, posted the largest stock price gain of any Massachusetts company in 2006. How is that possible for a manufacturer of contrast agents that posted lower sales than it did 20 years ago? Because investors are excited about two products in development: a diagnostic agent to detect cancer in lymph nodes, and an iron replacement therapy. 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.
Cardiva Medical Inc. (Mountain View, CA), a four-year-old company developing next-generation vascular access and closure devices, has won a 2006 Frost & Sullivan Award for entrepreneurial companies, according to devicelink.com. It won for the Boomerang Wire System, which is used in percutaneous catheterizations. The system is considered to be much safer and easier to use than previous methods used to close the opening of the femoral artery.
FDA Commissioner Andrew von Eschenbach has named Randall Lutter, PhD, to be acting deputy commissioner for policy. He replaces Scott Gottlieb, who recently resigned. Lutter had been Associate Commissioner for Policy and Planning, and before that was chief economist in the Office of Planning. In his new role, he will serve as lead advisor to von Eschenbach on agency policy.
DeviceTalk will return on Wednesday, December 27.
FDA has approved a first-of-its-kind device that can prevent or reduce brain damage in infants born with a brain injury caused by low levels of oxygen. The condition, hypoxic-ischemic encephalopathy, affects 5000-9000 U.S. infants per year. The Cool-Cap system, made by Olympic Medical Corp. (Seattle), cools the head while keeping the rest of the body at a temperature slightly below normal. It consists of a cooling unit, a control unit, temperature probes, and a water-filled cap. 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.
The long and tortured effort to create a safe and effective blood substitute suffered another setback yesterday when Northfield Laboratories Inc. (Evanston, IL) reported that in a study of its blood substitute, more patients receiving its treatment died than those who did not. But results for those treated exactly as specified were encouraging, the company said. 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.
Today’s New York Times has a fascinating article about the use of an unapproved excimer laser to treat a giant brain aneurysm in a very special case. When a brain aneurysm becomes very large, bypass surgery on the affected carotid artery is necessary. Traditionally, an artery is clamped during surgery. But in this one case, the aneurysm was so large that clamping was too risky; there was a good probability that stroke would ensue. 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.
After more than a month of strong speculation that Smith & Nephew plc (London, UK) would bid billions for Biomet Inc. (Warsaw, IN), a private equity group has agreed to acquire the company for $10.9 billion. Biomet has been looking for a buyer since April. The equity group consists of the Blackstone Group, Goldman Sachs Capital Partners, Kohlberg Kravis Robers & Co., and Texas Pacific Group. 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.
Implantable cardioverter-defibrillators can save and prolong the lives of people with irregular heart rhythms. But, reports the Washington Post, they often make the dying process more painful for those who are passing away. When a patient with an ICD is dying, the ICD may shock the patient repeatedly in a fruitless attempt to get his or her heart back to normal. The repeated shocks are often quite painful and have been likened to being kicked in the chest by a horse. 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.
An ex-chief medical officer for Johnson & Johnson’s Ethicon Inc. (Somerville, NJ) has filed a lawsuit against the company and alleges he was fired for raising concerns about the safety of some of the company’s medical devices. The lawsuit mentions an incident in April when the whistleblower, Joel Lippman, said he raised concerns about an instance in which the tip of an arterial cannula broke off during heart bypass surgery at least once. 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.
