A federal judge refused to grant Shelhigh Inc.’s request that the government release the tissue-based devices it seized last month because of concerns about sterility. Judge William Martini said he could not rule whether Shelhigh’s devices met GMP standards without holding a hearing, reports the Star-Ledger of Newark, NJ. He said that hearing will come as soon as possible. Shelhigh executives say the company’s future is in jeopardy if it cannot export the seized devices.
The judge urged both sides to try to reach a settlement, using a mediator if possible. But, as we predicted, Shelhigh has hired Larry Pilot to help in its defense. Companies who seek out Pilot often do so because he is willing to take on FDA in court. Shelhigh also rejected FDA’s request to recall devices it already shipped to hospitals. That’s not an indicator of being willing to settle, either. Â
James Mazzo, president and CEO of Advanced Medical Optics, told the media that the recall of its contact lens solution is not related to a manufacturing problem or a contamination issue, reports the Associated Press. Rather, he says, the problem more likely stems from users handling their lenses improperly. But he didn’t have a definitive answer, nor a sense of the recall’s financial impact on the firm.
Meanwhile, the New York Times speculates that this recall, combined with Bausch & Lomb’s recall last year, could drive consumers toward disposable lenses, which don’t need solution. While disposables make up 70% of the contact lens market in Asia and 40% in Europe, they are just 8% of the U.S. market.
Let’s draw this out one step further — will we see a spike in laser eye surgery? It’s not without risks, but, we are learning, nor is contact lens use.
I’ll be sticking with my glasses, thanks.
FDA announced late last week that Advanced Medical Optics (Santa Ana, CA) has voluntarily recalled its Complete MoisturePlus Multi Purpose Solution for soft contact lenses. Consumers who use the solution should stop using it immediately and discard it. They should also replace their lenses and storage container. As a result of a Centers for Disease Control investigation, the solution has been linked to a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. It found that users of the solution were seven times more likely to develop the infection than those who do not use it.
A similar scenario last year caused Bausch & Lomb to recall one of its contact lens solutions. Ironically, one day before the recall announcement, Advanced Medical Optics expressed interest in buying Bausch & Lomb. It said it might try to trump a private equity firm’s offer that B&L accepted earlier this month. B&L put itself up for sale after its bottom line and stock price took a beating over its recall. Â
FDA also states: “Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection, as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing, but Acanthamoeba is more difficult to treat.”
A Minnesota-based plastic surgeon is developing a diagnostic tool with the intention of detecting a silicone breast implant rupture. The mention of the technology is buried deep within a New York Times story about FDA’s requirements for patients with silicone breast implants to undergo routine MRI’s and the disagreement about this condition shared by many plastic surgeons. About four pages into the piece, a small paragraph talks about this interesting technology. According to the article, the dime-sized RFID tag, called Novalert, fits on the back of an implant. If it senses a silicone leak, the device emits a signal.
Upon a google search of “Novalert,” there is a San Francisco-based start up company named Novalert Inc. Its limited Web site states that the company is developing technology to monitor and control implantable devices, with a near-term focus on aesthetics. It sounds like it could be related to the device discussed in the Times piece, but the connection hasn’t been confirmed.
Legal action that takes place in the drug industry is an indication of areas where device companies need to be cautious. Although the device industry is quite adamant (as it should be) about the differences between drugs and devices, litigation is one area where we’re beginning to see similarities. Experts at device conferences during the past year have emphasized that we’re next and that it would be wise to look at what’s happening to drug companies to see if these problems are present in your organization. Yesterday evening, the Associated Press reported about a subpoena received by the drug company Amgen Inc. over promotional “and other” activities. While not much details were given, it noted that the subpoena sought documents from Amgen’s sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements, and corporate communications. Experts at a device conference a couple of months ago told attendees that the government has been looking at these very same documents at device companies in efforts to find evidence of a violation. Their strongest advice–conduct audits and make sure you respond to them appropriately.
Medtronic Inc. is beginning a large, randomized trial that will examine the safety of drug-eluting stents. The 8800-patient clinical trial will compare the company’s zotarolimus-eluting coronary stent system (Endeavor) with J&J’s sirolimus-eluting stent (Cypher). Medtronic enrolled the first patient in the study, called Protect, yesterday. The trial will look at overal stent thrombosis after three years. Other points of analysis will include a composite of death and nonfatal myocardial infarction. According to an investigator of the study, the trial is designed to give doctors the long term safety data that they’ve been needing.
Two New England-based women’s health companies are joining forces as Hologic Inc. (Bedford, MA) announced that it will be acquiring Cytyc Corp. (Marlborough, MA). The $6.2 billion deal is expected to be completed in the third quarter. The combined entity will be called Hologic and will carry the torch of both companies. Jack Cumming, chief of Hologic, said that the merger is about creating growth, despite the fact that it will save from $25 to $30 million each year. Their combined portfolio will range from breast and cervical cancer screening, diagnosis, and treatment, to osteoporosis to contraception.
The relationship between hospitals and the medical device industry needs more integration, proclaimed Mary Ann Hilliard, chief risk counsel for the Children’s National Medical Center (Washington, DC) last week. Hilliard spoke at a risk management conference jointly held by AdvaMed, FDA, and Virginia Tech. The disconnected relationship causes problems when it comes to equipment use error among clinicians. Linking both industries would both improve processes and drive down errors. From Hilliard’s perspective, although technology in hospitals is incredibly innovative, until there is collaboration between both industries, hospitals won’t be able to reduce sentinel events. She suggested the presence of more human factors engineers and reliability experts in hospitals, especially when conducting root cause analysis. Another part of the solution is more transparency in sharing data–however, with current liability issues, this is a major challenge.
Brain-related illnesses generate more healthcare costs than any other therapeutic area—$1.1 trillion annually in the United States, noted Zack Lynch, executive director of the Neurotechnology Industry Organization (NIO). Lynch made his remarks to kick off the Neurotech Industry Investing and Partnering Conference, taking place May 17-18 in San Francisco.
In 2006, neurotech products across these three sectors generated more than $120 billion in revenue with 10% growth. Despite its already large size, Lynch said neurotech is poised for large growth with several factors driving this demand. Primary among these, he said, is that neurotech companies address the largest unmet medical market. The total number of people affected by brain-related illnesses worldwide has reached more htan 2 billion people, which means that nearly one in three people suffer from a brain-related illness.
“Major medical device companies like Johnson & Johnson, Boston Scientific, and Medtronic are playing a very important role in this sector,†said Lynch. “These companies profited from the explosion of medical devices for cardio indications, an $18 billion market. We’ll see a similar expansion of neurodevices in the next 10 years.â€
NIO was formed just a year ago. In March, the group unveiled a National Neurotechnology Initiative in Washington, DC. Lynch said the initiative will establish a federal research and development program based out of a national coordination office to direct multiagency efforts in neurotechnology. “It is similar to other federally funded research and development projects that have been extremely successful such as the human genome project,†said Lynch. The NNTI has four program components: the establishment of national research centers in neurotechnology, a major research initiative program in neurotechnology, a translational development program to ensure U.S. neurotech leadership with FDIR, and research into the ethical, social, and legal implications of neurotechnology. “We’ve already begun to draft legislation, and we’re beginning to collect feedback from our members,†he said.
So maybe it’s not so strange to think of a patient as a washing machine. That is, it’s not a bad idea to give a patient the same kind of warranty that a washing machine or a television would have. That is what the Geisinger Health System group in Wilkes-Barre, PA is doing. A New York Times article talks about how the healthcare group has overhauled its system so that patients undergoing surgery do not pay additional fees for any related procedures done within 90 days. If a complication arises, the group will not bill the insurer. According to the group, the process encourages hospitals and doctors to provide high-quality care that can prevent costly mistakes. The article gives the example that nearly half of American patients never get the most basic recommended treatments-such as an aspirin after a heart attack or antibiotics before hip surgery. One of the reasons cited for this lack of basic care is that hospitals and doctors do not have an incentive to prevent such occurrences.
So far, the only insurer that Geisinger has contracted with under the new arrangement is its own insurance unit. Eventually, though, the group hopes to attract other insurers and employers that provide health benefits by expanding the approach into other lines of care.
It could lead to better standardization of healthcare. Patients get peace of mind that even if something goes wrong, they are taken care of. Plus, insurers may be more likely to approve surgeries if they won’t have to pay extra. It’s ironic to think that treating a patient like a machine could actually go a long way toward increasing humane practices in hospitals. Now where’s my warranty?
