MASSDEVICE ON CALL — New allegations against Medtronic Inc.’s (NYSE:MDT) Infuse bone growth product may bring down its sales, which were last reported at $800 million per year.
Amid an ongoing investigation into whether Medtronic and its paid consultants concealed information linking the Infuse system to male infertility, a critical review published in the Spine Journal alleged that researchers on the company’s payroll also hid the product’s tendency to cause excess bone growth in the spinal canal.
New CEO Omar Ishrak issued his first public statement on the controversy yesterday, defending the Fridley, Minn.-based company’s published data on Infuse and maintaining the company’s commitment to patient safety.
Wall Street analyst Tao Levy of Collins Stewart warned that the study, the second to allege hidden risks in the past two months, may cause sales to slide for the med tech giant. A $100 million reduction in Infuse sales would lower MDT’s profit by 3 cents per share, Forbes reported.
Research from a recent clinical trial found that nearly three quarters of patients implanted with Infuse had unwanted bone growth in their spinal canals, and the trial was cut off after only 34 of hundreds of enrolled patients received the implant.
The allegations continue to stack the deck against the Infuse implant, which has been widely used to fuse spinal vertebrae during surgeries since 2002.
A study published last month accused Medtronic of concealing that the bio-engineered bone growth protein can increase the risk of infertility in men. Earlier this month two U.S. Senators demanded that the medical device giant turn over documents relating to internal correspondence with paid consultants and researchers who worked on product trials, expanding the investigation into whether physicians on the company’s payroll concealed the infertility risk.
MDT stock was down 2 percent to $38.23 in morning trading today after closing at weekly high of $39.01 yesterday.
Trade agreements swap Medicare for worker retraining
Long-delayed trade agreements with South Korea, Colombia and Panama made some breakthrough progress yesterday, hinging on $1 billion per year promised for retraining programs for displaced workers, Politico reported.
"These free trade agreements, together with Trade Adjustment Assistance, will boost our economy by billions of dollars and create new jobs and opportunities here at home. This proposal opens lucrative new markets to American ranchers, farmers and small businesses while ensuring U.S. workers have all the help they need to adapt and thrive in the 21st century global economy," Senate Finance Committee chairman Max Baucus (D-Mont.) said in a statement.
The Medical Imaging & Technology Alliance expressed "dismay" at the decision, which saw medical imaging reimbursements cut to pay for the retraining assistance.
"Asking senior citizens to compromise their health care and ability to access early detection to pay for deals made on free trade agreements is simply wrong," said Dave Fisher, executive director of MITA, in a statement. "Congress and Medicare have cut imaging reimbursements five times in five years and today spending on medical imaging in Medicare is below 2006 levels. Enough is enough."
Physician spy program put on hold
An Obama Administration plan to secretly survey U.S. physician’s offices patient access has been put on hold, the New York Times reported.
Concerned about the the shortage of primary care physicians, the administration was recruiting a team of “mystery shoppers” to call doctors offices and request appointments to determine the state of access as well as determine whether physicians were preferentially opting for private or government insured patients.
"We have determined that now is not the time to move forward with this research project," the Department of Health and Human Services said late Tuesday.
Blood transfusions overused?
Too many patients are receiving unnecessary blood transfusions, according to an advisory from the Dept. of Health & Human Services.
"There is both excessive and inappropriate use of blood transfusions in the U.S.," advisers to HHS Secretary Kathleen Sebelius concluded earlier this month. "Improvements in rational use of blood have lagged."
The agency urged alternatives to the procedure for certain conditions and operations and called for a national standard on when to opt for a transfusion, the Associated Press reported.
AIDS groups defend health care overhaul
Cuts and obstacles to health care reform would undermine efforts to increase HIV and AIDS testing and would allow insurance companies to deny coverage to people who have the diseases, advocates and legislators argued last week.
"I am deeply concerned that the progress we have made against this devastating disease is in danger of being reversed," said Rep. Maxine Waters (D-Calif.) said during a press conference, Healthwatch reported.
Combating HIV and AIDS "means protecting the Affordable Care Act," said Julie Scofield of the National Alliance of State & Territorial AIDS Directors.