Bone Morphogenetic Proteins Including InFuse on the Decline Amid Reports of Serious Complications and Adverse Events

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When bone morphogenetic proteins (BMPs) such as InFuse were approved in 2002, they were considered a less painful method for spinal problems including severe back pain. But by the end of 2008, it became clear that BMP use was on the decline thanks, in part, to reports of life-threatening and life-altering adverse events that flooded into the U.S. Food and Drug Administration (FDA).

The use of Infuse rose dramatically from 2002 until 2008. A recent study published in The Spine Journal found that the proteins were used in 45.2 percent of lumbar and 13.5 percent of cervical fusions. When federal health regulators started receiving an increasing number of adverse events and complicatin reports, the agency issued a Public Health Notification in July 2008. For the new study, researchers examined how these safety concerns impacted the use of InFuse and BMPs in elective spine surgery.

Scientists observed a 44.7 percent decrease in the rate of InFuse use with lumbar fusion. At its peak, InFuse was used in 45.2 percent of lumbar fusions; by the end of 2012, InFuse was used in only 25 percent of lumbar fusions. Researchers also observed a 56 percent reduction in InFuse use for cervical fusion – down to 6 percent by the end of 2012, from a peak of 13.5 percent, according to The Spine Journal.

Morbidity, blood loss, longer operating times and limited tissue graft available prompted surgeons to begin looking into alternative fusion procedures such as BMPs. As the use of InFuse increased, surgeons returned to the original studies on the device to reevaluate donor-site morbidity, revision rates, adverse events and patient-reported outcomes. Pivotal trials that eventually lead to InFuse’s approval have been accused of design flaws and industry influence, The Spine Journal reported.

In 2012, a U.S. Senate Finance Committee investigation found that ‘‘Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic.’’ When the committee reanalyzed patient-level data and a meta-analysis of the industry-sponsored FDA trials that led to InFuse’s approval in 2002, it determined InFuse provided no advantage over iliac crest bone grafts and the device’s risks were understated in journal publications, according to The Spine Journal.

InFuse was viewed as a safer, less-painful alternative to grafting tissue from a patient’s own hip, but in 2008, amid a growing pile of adverse event reports, the opposite became clear. Many of the reports cited life-threatening complications including bone and nerve injury, male infertility, infection, urinary problems, and cancer.

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Health Officials Investigate an Injectable Painkiller Possibly at the Heart of an HIV Outbreak in Southern Indiana

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A fast-spreading HIV outbreak is wreaking havoc in Indiana and a new form of injectable painkiller could be causing some of the risky behavior leading to spread of the virus.

According to Time, federal regulators from the U.S. Food and Drug Administration (FDA) told Endo Pharmaceuticals in May 2013 that a new form of its widely used prescription pain pill Opana could be driving drug addicts to inject the drug intravenously or snort it. The new version of Opana was introduced by Endo in 2012. The company said the pill was designed to be abuse deterrent. A previous version of the painkiller was easily crushed and snorted or dissolved and injected, but the new version had a special coating that supposedly made abusing it more difficult. The drug maker took the previous version off the market and asked the FDA to rule that it had been unsafe, thus preventing other drug manufacturers from introducing generic versions of the pill.

The FDA rejected Endo’s request, saying even though Opana’s new coating made it more challenging to crush and snort, the agency found that “it may be easier to prepare OPR for injection.” Federal health regulators worried about “the troubling possibility that the reformulation may be shifting a non-trivial amount of Opana ER abuse from snorting to even more dangerous abuse by intravenous or subcutaneous injection.”

The HIV outbreak in southern Indiana has exploded from eight cases in January to 166 as of June. Officials from the U.S. Centers for Disease Control and Prevention (CDC) and local officials in Scott County said 96 percent of the patients they interviewed said they were injecting Opana, according to an April CDC  alert obtained by Time.

Officials in Scott County told Time that drug abusers found they could cook down the abuse deterrent coating on the pills and dissolve and prepare it for injection. Opana has become a favorite over heroin, despite it being more expensive and having a shorter effect. Some Scott County addicts admit to shooting up more than 20 times a day. They shoot up and transmit HIV to each other.

Endo, based in Pennsylvania, denies Opana is at the heart of the HIV outbreak in Indiana and has suggested generic versions of the pill without the “abuse deterrent” coating might be to blame. But Scott County Sheriff Dan McClain refutes the idea. “I’ve got an evidence room full of Opana over there right now, and I don’t have any generic forms of that pill that are being purchased off the street,” McClain told Time in April.

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Packaging Change Leads to Recall for Baxter International Vascu-Guard Patch

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Baxter International, Inc. has issued a voluntary recall for four lots of a peripheral vascular patch because a change in packaging affected the patches’ surface, making it difficult to correctly orient the patch, possibly endangering patients.

The Illinois company reported 51 complaints involving the patch to the Food and Drug Administration (FDA), including postoperative thrombosis and stroke, according to an FDA statement. “Baxter is in the process of an in-depth investigation, and will share additional information as it becomes available,” a Baxter spokesman John O’Malley said via email to Qmed.The Vascu-Guard patch is used to rebuild peripheral blood vessels such as the carotid in the neck and the renal in the kidneys, Qmed explains. Baxter is recalling the patch because it may be difficult for surgeons to distinguish the smooth side from the rough side of the implant, according to FDA. The packaging change caused the smooth surface of the patch to be too rough. If the surgeon implants the rough side of the patch incorrectly (toward the bloodstream), blood clots may form on the patch, exposing the patient to embolism, reduced blood flow, stroke, organ failure, or death, the FDA said.

Patients who need repair of smaller arteries are at higher risk of blood clots forming within a blood vessel because blood flows more slowly through those vessels, the FDA said. Patients whose blood disorders cause excessive clots to form may also be at a higher risk of forming clots on the surface of the patch. In a statement, Baxter said, “no causal association has been established” between the recalled patches and adverse health events. The product codes for the recalled patches are available on the FDA’s website. The company is continuing to investigate the issue, Qmed reports.

The FDA categorizes this as a Class I recall, the most serious recall category, reserved for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Baxter began notifying customers of the recall on May 2, 2015. The company advises health care facilities to remove the recalled patches from inventory and return them to Baxter for credit. Customers should contact Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, from 7:00 a.m. and 6:00 p.m., Central Time, for further information. The company says the Vascu-Guard patches packed in a plastic jar filled with sterile water and 1% propylene oxide are unaffected by this recall and can still be purchased.

The FDA encourages healthcare professionals and patients to report any adverse events or side effects related to the use of the Vascu-Guard patch to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

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Immediate-Release Opioids Should have Boxed Warning, Lawmakers Say

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A boxed warning, the most serious type of warning, should be placed on immediate-release (IR) opioids, legislators say. Regulatory Affairs Professionals Society (RAPS) reports that a group of two dozen Democratic legislators sent a June 4, 2015 letter to FDA Acting Commissioner Stephen Ostroff proposing a stronger label to reflect “the serious risks of abuse” associated with the pain killers. Concerns were fueled by “the national public health crisis of prescription drug overdoses.” the letter said.

Legislators cited data from the Centers for Disease Control and Prevention (CDC) showing that opioid-related overdoses have gone up four-fold since 2000. There are also concerns related to neonatal abstinence syndrome (NAS); this is when opioid use during pregnancy causes newborns to be born addicted to the drugs.

The FDA already requires a boxed warning for extended-release (ER) opioids and long-acting (LA) opioids, RAPS reports. The label reads: “Warning: Addiction, abuse and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; interaction with alcohol; and cytochrome P450 interaction.” The letter points out that “FDA chose to apply this black box warning only to ER and LA opioid analgesics” and not IR opioids.

The lawmakers point to new evidence in support of a stronger warning for IR opioids. “A recent systematic review by the Agency for Health Research and Quality (AHRQ) did not identify a single study that found statistically significant differences between short versus long-acting opioids on the risks of overdose, addiction, abuse or misuse in patients with chronic pain,” the letter states. According to the legislators, some estimates indicate that IR formulations account for 91 percent of all outpatient opioid prescriptions.

“Given the established risk of addiction, abuse and overdose from all opioid analgesics, as well as the emerging public health threat of NAS, we believe that the FDA should ensure that all IR opioid formulations bear the same black box warning as the ER/LA formulations,” the lawmakers stated. “We believe that this information is crucial to patients and prescribers.”

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Lawsuit Filed Over Medtronic’s Use of InFuse Bone Growth Device for Off-Label Purposes

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A lawsuit has been filed against medical device maker Medtronic on behalf of numerous patients who allege the company’s InFuse bone graft product caused injuries including catastrophic, unchecked bone growth in the spinal column.

Court documents allege product liability and fraud against Medtronic Inc. and its subsidiaries, Medtronic Sofamor Danek, USA, Inc., and Medtronic SofamorDanek, Inc., over its InFuse Bone Graft LT-Cage Lumbar Tapered Fusion Device System. InFuse is only approved by the U.S. Food and Drug Administration (FDA) for use in a single level fusion. The bone growth device was approved for singular placement between two vertebrae in the lumbar region in 2002. In 2004, federal health regulators approved InFuse for use in the L4-S1 region, specifically for a surgical approach known as the Anterior Lumber Interbody Fusion (ALIF).

The FDA’s limited approval of InFuse was intended to also limit Medtronic’s marketing and sales of the device, according to court documents. Rather than go through the traditional Pre-Market Approval (PMA) channels to gain expanded approval from the agency, however, Medtronic allegedly did so through the use of an illegal, false and deceptive marketing scheme to promote off-label uses of InFuse.

As part of its marketing for InFuse, Medtronic released a “Fact Sheet” in 2002 promoting the results of company-sponsored scientific studies. The lawsuit alleges Medtronic deliberately concealed critical safety information in the “Fact Sheet” and studies. The medical device maker claimed that the studies were “outside objective reports,” but were, in fact, written or re-written by Medtronic’s own highly paid agents. Court documents also allege the company was actively involved in the writing and editing of the articles, as well as decisions to include and exclude vital health and safety information.

As early as 2006, doctors reported adverse events associated with the unapproved use of Infuse in the cervical spine including swelling, dysphagia (difficulty swallowing) and dysphonia (voice disorders), court documents show. The authors of a peer-reviewed article published in The Spine Journal, the safety information Medtronic allegedly concealed – including adverse events and serious increased risks – may actually be 50 times more than the company reported.

The lawsuit alleges that Medtronic’s false and deceptive marketing scheme proved so effective that 85 to 90 percent of the InFuse sales were derived from off-label uses. According to lawsuit documentation, an off-label use rate this high cannot occur without major off-label promotion, and the scheme raked in billions of dollars for Medtronic.

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Washington, D.C.’s Largest Public School System Agrees to Pay $19 Million to Settle Whistleblower Lawsuit

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Washington, D.C.’s largest public school system food vendor has agreed to pay $19 million to settle a lawsuit alleging that the company overcharged the District and mismanaged the school meals programs. According to the suit, food often arrived at schools late, and were often spoiled or in short supply.

A former director of food services for D.C.’s Public Schools (DCPS) filed the lawsuit against Chartwells and Thompson Hospitality. The tipster served as executive director of the school system’s Office of Food and Nutritional Services from 2010 until he was fired in early 2013. Chartwells and the Office of Food and Nutritional Services formed a joint venture that provided food services for schools in D.C. beginning in 2008. The whistleblower’s suit prompted an investigation and then a complaint from the District’s attorney general’s office, according to The Washington Post (The Post).

“Chartwells has quite reasonably acknowledged and addressed mistakes it made in administering the contract to provide food and food services to DCPS,” Attorney General Karl A. Racine said in a statement Friday that was obtained by The Post. “It is important to ensure that contractors who receive District funds are held accountable for fulfilling their obligations under the contracts, and today’s settlement does just that.”

Last year, the whistleblower settled a separate lawsuit with the school system for $450,000. In the suit, the man alleged that he was fired for shedding light on how the system mismanaged the contract.

“The issue of private food vendors prioritizing profits over the well-being of students is a national concern,” the tipster said. “I urge all school districts using private food vendors to examine their contracts and the performance of those vendors.”

Owen Donnelly, a spokesman for Chartwells, said in an e-mail to The Post that the company “denies any wrongdoing and has agreed to resolve the issues so that focus continues to be on nourishing the bodies, minds and spirits of students to pave the way for a lifetime of success and well-being.”

According to Donnelly, the problems at DCPS were the result of cost overruns and “related reconciliations.”

“In our seven years at D.C. Public Schools, we have significantly increased the quality of food service while saving the District millions of dollars,” he told The Post.

Chartwells had encountered problems in other parts of the country. In 2012, Chartwells’s parent company, Compass Group USA, paid $18 million to settle allegations by New York’s attorney general that more than three dozen school districts were overcharged by the company when it failed to extend discounts required by their contracts. Then, last fall, students at a Connecticut high school participated in a well-publicized boycott over the quality of the food the company provided, The Post reported.

In settling the DCPS lawsuit, Chartwells agreed to pay $14 million in credits and payments to the school system and committed to pay an additional $5 million in philanthropic support for the schools. Part of that sum included $4 million to the D.C. Public Education Fund for “innovative programs” and $1 million to a number of nonprofit organizations that promote literacy and provide mentors, college scholarships and academic enrichment, according to The Post.

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Pfizer Internal Report Warns of Possible Link between Zoloft and Birth Defects

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An internal report from Pfizer Inc. shows a scientist warned company executives last year about a potential link between the anti-depressant drug Zoloft and birth defects and recommended changes to the medication’s warning label.

The report could complicate the company’s efforts to fend off lawsuits from parents of children with malformed hearts. Pfizer has consistently rejected claims that Zoloft (sertraline) caused the abnormalities and on Monday the company said the document was taken out of context, Bloomberg Business reports. The child’s family is seeking at least $2.4 million to cover her future medical expenses.Pfizer faces more than a thousand lawsuits alleging the company sold Zoloft knowing it could cause cardiac abnormalities in newborns. The company successfully defended itself in the first lawsuit to go to trial in April, before the disclosure of the document last week in a case in Philadelphia, Bloomberg Business reports. Los Angeles attorney Jim Morris said, “I don’t see how they could go before a jury with a straight face and make that argument now that these documents have surfaced.” (Morris has tried product-liability cases against Pfizer, though none involving Zoloft.)

In the 1998 report introduced into evidence in the Philadelphia trial, Pfizer researchers acknowledged more than a dozen birth defect reports for which Zoloft use could not be ruled out as a cause. Pfizer said the internal review had been mischaracterized by the plaintiff’s lawyers. Company spokeswoman Christine Rogen Lindenboom said plaintiffs’ attorneys had “cherry-picked” data from the review of adverse event reports and ignored conclusions that contradicted their testimony. Lindenboom said recent filings with U.S. and European health regulators support Pfizer’s contention that no credible link has been found between Zoloft and birth defects.

Pfizer wants to persuade the Philadelphia jury to reject the claim that the child’s birth defects, including a hole in her heart, were caused by her bipolar mother’s use of Zoloft, according to Bloomberg Business. In April, the jury in a state court in St. Louis, rejected arguments that Zoloft caused heart defects that required a boy to have three open-heart surgeries and to have a pacemaker implanted.

Francesca Kolitsopoulos, associate director in Pfizer’s Worldwide Safety Strategy unit’s epidemiology group, said she reviewed published studies that showed an association between Zoloft and cardiac malformations, “which could be causal.” The April 2014 review concluded that researchers had found links between Zoloft use and septal heart defects, a congenital disorder that features a hole in a baby’s heart. The researchers also found ties between the Zoloft and omphalocele, a birth defect in which the intestines or organs form outside the belly. The report shows that Kolitsopoulous proposed modifying the Zoloft warning label to indicate that researchers had identified potential links to birth defects, according to Bloomberg Business.

The 1998 report, made public for the first time last week in the Philadelphia trial, shows that Pfizer safety monitors reviewed 50 side-effect reports from pregnant women who had taken Zoloft. Twenty-five cases involved “congenital abnormalities” or other adverse events “possibly related” to Zoloft use. In 16 of the cases, “there was no obvious cause” for the defect other than the mother’s use of the anti-depressant, the review showed, according to Bloomberg Business.



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