Not all breast tumors are the same. Nor are all bladder tumors. Nor are all colorectal tumors. Yet medicine has considered them such for years. Treatments have focused on which organ the tumor resides in, yet we know that no single treatment works for all tumors found in a certain organ.
There is now a test that will enable scientists and caregivers to differentiate malignant tumors. FDA has cleared the The Pathwork Tissue of Origin test, which can help determine what type of cancer cells are present in a malignant tumor. It compares the genetic material of a patient’s tumor with genetic information on malignant tumor types stored in a database. It uses a microarray technology to analyze thousands of pieces of genetic material at one time.
“With the help of microarray technology, [scientists] will be able to classify these types of cancers in a standardized non-reader dependent manner based on the patterns of gene activity in the tumor cells,” said CDRH director Daniel Schultz. The test’s software converts the scanned image data to gene expression measurements. The gene expression patterns are compared with known gene expression patterns in the database that correspond to different tumor types. And that knowledge can help clinicians determine the best course of treatment.
The test is made by Pathwork Diagnostics. It uses a gene expression array made by Affymetrix Inc.
Abbott said it has received a subpoena from the Department of Justice related to the sales and marketing of its bile-duct stents, according to a release published on devicelink.com. It is estimated that about 90% of the time, bile-duct stents are used off-label, and last year FDA held a meeting for bile-duct stent manufacturers to go over what they can and cannot promote to doctors. Abbott said that the government is seeking to determine whether the activities violated laws such as the Federal False Claims Act, the Food and Drug Cosmetic Act and the Anti-Kickback Statute in connection with Medicare or Medicaid reimbursement paid to third parties.
UPDATE: Johnson & Johnson and Boston Scientific have also received subpoenas.
UPDATE 2: Medtronic has received a subpoena as well.
The benefit of certain screening tools for oral cancer is being put into question by recent studies, which have concluded that evidence can’t “support or refute” the use of such devices. According to one professor at Boston University’s School of Dental Medicine, there isn’t any scientific evidence demonstrating that the devices help dentists detect precancerous lesions better than the naked eye and suggests clinical trials are needed. However, some dentists that use screening tools like ViziLite say using the devices gives them the chance to take a second look in spotting lesions, which could still help detect cancer early.
Integra Life Sciences (Plainsboro, NJ) is planning to buy Theken Spine (Akron, OH) in a deal that would create the Integra Spine Division. The $75 million acquisition would include $125 million more if Theken meets future revenue milestones, according to Cleveland’s The Plain Dealer. The purchase includes Theken Spine LLC, Theken Disc LLC, and Therics LLC, and Integra plans on keeping the companies’ headquarters and facilities in Akron. Theken Spine’s product line includes plates, screws, and synthetic bone products, and Theken Disc is a research-stage company that develops spinal implants.
Following complaints from doctors of a high failure rate, Zimmer has halted the sales of its artificial hip socket. However, the product has not been recalled. Doctors have been reporting that the failure of the Durom cup has resulted in patients having to undergo replacement surgery, Although Zimmer didn’t find the device to be defective, some experienced surgeons have had trouble implanting it, according to The New York Times. In April, a Los Angeles surgeon brought attention to the implant problems in a letter to his colleagues.
Zimmer expects the sales suspension to slash $20 to $30 million from its sales estimates. The company is also stopping its U.S. premarketing trials of a resurfacing system.
A company that specializes in treating conditions of premature infants has received FDA clearance to market a device that helps babies learn to feed correctly. KCBioMediX Inc.’s (Shawnee, KS) NTrainer System combines hardware and software that assesses the patterns of a premature baby’s ability to coordinate breathing, swallowing, and sucking in order to feed (know as non-nutritive suck, or NNS). It examines the NNS patterns and helps establish the correct sucking patterns for babies, which benefits them because it promotes faster weight gain and physical growth. The system trains the baby’s brain in a sense, enabling the baby to speed up the ability to eat without a feeding tube.
KCBioMediX was founded to commercialize devices developed at the University of Kansas that assess the NNS of premature babies. It’s possible that that target market for the device could be worth more than $1 billion.
Premier Inc., one of the nation’s largest hospital group purchasing organizations, isn’t waiting for FDA to get around to requiring unique device identification. It announced in a release published on devicelink.com that it will require all medical device manufacturers it has contracts with to adhere to standards that essentially require unique device identification — which usually consists of bar codes or RFID and can help in tracking devices in case of recalls, and preventing medical errors.
Industry originally opposed unique device identification because of the difficulties in coming up with a single system that would work for all medical devices. FDA and industry have struggled to come up with one, and the process has taken a very long time, even though Congress finally mandated unique device identification in the FDA Amendments Act of 2007. Premier apparently had enough, and imposed its own standards. It hopes its action will force FDA to act.
Premier has adopted the GS1 supply chain standards. This includes a Global Trade Identification Number, the Global Location Number, and the Global Data Synchronization Network. The first is a standardized number used to identify medical devices at various packaging levels. The second is a standardized number used to identify who has been in contact with a device. The third stores data from the first two, and allows users to access information about each device.
There aren’t many devices approved for specific use in children in the United States. Some go abroad to get what they need; others forego treatment at great consequence. Most often, doctors use devices designed for adults off-label, or hand-make their own devices. The main problem is that the pediatric-use market isn’t large enough to justify the investment of developing a device for children. Last year’s FDA Amendments Act provided financial incentives for companies developing pediatric devices, but also required them to track patients at their own expense, so it doesn’t really do much to address the cost-of-development issue. Ethical issues also come in to play. Can you do a randomized clinical trial on children?
On Wednesday, reports Reuters, the National Institutes of Health is sponsoring a meeting on pediatric devices, and an AdvaMed spokeswoman says industry will look to it for guidance.
Arthrocare Corp. said it will restate its earnings for 2006 and 2007, as well as for the first quarter of 2008, after its audit committee determined “that the financial statements for such periods can no longer be relied upon.” Translation: Someone somewhere along the line made a big, big mistake. The new statements will reduce 2006 revenue by $4-7 million, 2007 revenue by $20-25 million, and 2008 revenue by $2-5 million.
Now, the company’s explanation makes it seem like there was no fraud at play, just a miscategorization. Here is how it categorizes the mistake: “The relationship between the company and DiscoCare, Inc. during the periods being restated was a sales agent relationship, rather than that of a traditional distributor; and the sales price of products sold to State of the Art Medical Products, Inc.(”SOTA”), Boracchia & Associates and Clinical Technology, Inc. cannot be considered fixed or determinable upon shipment by ArthroCare during the periods being restated. The company will therefore account for sales by ArthroCare of products to each of these entities from the third quarter of 2006 to March 31, 2008, under a sell-through revenue recognition method that is appropriate for both of these situations, as opposed to a sell-in method. Under the sell-through method, revenue is not recognized until after the surgery is performed or a subsequent sale to another customer occurs. Sales to these companies for periods prior to the third quarter of 2006 will continue to be accounted for under the previous method of revenue recognition, either sell-in or sell-through, depending on the terms of the previous contract with each company.”
Some other things from the affected financial statements will also be recategorized, and the audit committee will oversee a review of the firm’s internal controls — a review that will involve outside investigators and may expand beyond that scope if necessary.
Shares of Arthrocare, which makes a variety of surgical instruments that work by dissolving soft tissue, fell 21% in early trading, reports Reuters.
An FDA inspection of a Cardinal Health facility in Dublin, OH that distributes point-of-use sharps containers has determined that the facility does not have adequate management controls as part of an effective quality system. The inspection found that a number of a quality system procedures have not been established, according to a May 28 warning letter. Among the procedures lacking are written corrective and preventive action procedures, design change control procedures, complaint procedures, and medical device reporting procedures.
Additionally, FDA’s letter says a management representative has not been appointed to ensure that the quality system requirements are met, and management reviews do not ensure that the quality system satisfies the requirements of CFR part 820. The letter also cites the firm for failing to conduct quality audits and failing to have a procedure for acceptance and rejection of incoming product.
–James G. Dickinson
