A new study published in the New England Journal of Medicine has revealed that orthopedists failed to disclose $4,000,000 in payments from companies that manufacture artificial hips and knees. The discrepancy in payment disclosure was found after a new study compared what medical device companies disclosed in relation to the doctors’ disclosures at the March 2008 annual meeting of the American Academy of Orthopaedic Surgeons.
In 2007, medical device companies agreed to disclose such financial information as part of a US Justice Department investigation in which the federal government accused device companies of violating anti-kick back laws by remunerating doctors for using their products. Companies involved in the Justice Department probe included Zimmer Holdings Inc. and Biomet Inc. of Warsaw, Ind.; Stryker Corp. of Kalamazoo, Mich.; Smith & Nephew PLC of London; and the DePuy Orthopaedics unit of Johnson & Johnson, New Brunswick, N.J.
According to the research, 344 payments were made to orthopedists while only 245 doctors revealed the payments.
Medical devices such as artificial hip implants, knee implants, and other implantable medical devices have experienced a huge growth in use and popularity in the last decade. More patients are receiving some form of implantable medical device than ever before. Yet, in spite of the surge in usage, there is no protocol for tracking or monitoring these devices.
“There is no system for being informed of what the problems are with the products you have in your body. Even your physician may not know,” said Terry Fadem, president of the Biomedical Research and Education Foundation in Philadelphia.
If a problem arises with a particular medical device such as an artificial hip or knee, doctors and industry professionals have know way of knowing who received the devices. This is not an insignificant issue since 2,500 medical devices were recalled in 2008 alone. In 2006, surgeons implanted a million artificial knees and hips. That number is expected to quadruple by 2030.
In the first seven months of 2009, over 1,000 recall notices have been issued for medical devices such as pacemakers, artificial hips, tracheal tubes, and pain pumps. Without a centralized data system like the medical registry, industry officials admit it is very difficult to track the faulty devices and ensure consumer safety.
The new FDA chief, Margaret Hamburg, recognizes the problem and has vowed to make post-market safety a priority during her tenure. Hopefully, that will include a national medical registry for all medical devices so that doctors and industry officials can more easily monitor the devices they implant in patients.
The United States Supreme Court has rejected the Diocese of Bridgeport’s appeal to keep their church documents sealed. The 12,000 pages of documents are related to priest sex abuse lawsuits resolved in the 1990’s. Eight years ago, the NY Times, the Boston Globe, the Washington Post, and the Hartford Courant filed suit to unseal the documents and make them public. A Connecticut lower court ruling approved the unsealing which led to the diocese’s appeal to the Supreme Court.
According to a story in the Hartford Courant, “Late Monday, attorneys for the diocese filed motions at Superior Court in Waterbury seeking a status conference to determine which documents will be made public and to ensure that the few documents the state Supreme Court ruled should be sealed remain so.”
The Diocese of Bridgeport has one last attempt pending before the US Supreme Court concerning its appeal of the Connecticut Supreme Court’s concerning public disclosure of the documents.
Allergan, the maker of Botox, has filed a lawsuit against the FDA and the Justice Department for restricting their marketing efforts and violating their First Amendment rights to free speech. At issue in the lawsuit is a pharmaceutical company’s ability to market their products for so-called off-label uses, something which is currently prohibited by FDA regulations.
While other pharmaceutical companies have not joined the lawsuit, they are watching it closely. The outcome will likely affect the manner in which they conduct their marketing efforts for years to come. Botox is currently approved by the FDA to treat crossed eyes, eyelid spasms, excessive sweating, and wrinkles. Doctors are free to prescribe Botox for any off-label use they deem appropriate. The FDA restriction only prohibits pharmaceutical companies such as Allergan from marketing their products such as Botox for off-label uses.
In their lawsuit, Allergan contends that this restriction unfairly limits them from educating healthcare professionals on other uses of Botox. The FDA has not allowed such off-label marketing because the so-called off-label uses have not been subject to the same scrutiny as for those for which the drug has been approved. This is really a consumer protection issue. If drug companies are allowed to market their products for unapproved uses, it makes the FDA’s regulatory powers irrelevant and places the average consumer at risk.
Botox has received stricter labeling requirements from the FDA after dangerous side effects had been reported. Such adverse effects include difficulty swallowing and breathing problems. To date, sixteen people who had received Botox injections have died as a result of the side effects as a result of dosage and prescription errors.
A Canadian Catholic bishop has resigned his post and is facing criminal charges of possessing and importing child pornography. Bishop Raymond Lahey has turned himself in to law enforcement authorities in Ottawa after Canadian border agents performed a random check and found lewd images of children on his laptop computer. Police have seized the laptop as well as a number of thumb drives in the bishop’s possession. Lahey was returning to Canada on a flight from Britain when he was detained in September.
Lahey was bishop of the Canadian Catholic diocese of Antigonish before his resignation. This past August Lahey was credited with settling a $15 million lawsuit concerning child sexual abuse by priests in his diocese involving a notorious child sex ring at the Mount Cashel orphanage in St. John’s. Lahey posted a $9,000 bail under the condition that he refrain from using any computer equipment and avoid places where minors may be present. His next court date is scheduled for November 4, 2009. In the meantime, Lahey must remain at Les Pères Trappistes in Rogersville, N.B., and must report bi-weekly to the local Royal Canadian Mounted Police detachment.
This is a particularly disturbing story for Catholics and non-Catholics alike on many levels. The case involves a Catholic bishop found in possession of child pornography who had publicly decried the suffering of sexual abuse victims. In fact, he had testified in the case involving the sex abuse of minors at the Canadian orphanage and had publicly stated that he desired to assist in the healing of abuse victims.
Judge Virginia M. Hernandez Covington of the United States District Court for the Middle District of Florida certified a class action lawsuit against Raytheon Co. on behalf of the Azalea neighborhood residents of St. Petersburg, Florida. The class action lawsuit after a toxic plume of chemical was discovered in the neighborhood groundwater. The toxic plume resulted in a devaluation of property in the Azalea neighborhood.
An expert hired by our team of lawyers found that the toxic plume 1 mile long by 1.7 miles wide. The Rice University expert, Dr. Philip Bedient, has concluded that “The results from 2008 clearly show that the plume is continuing to expand and it is clearly not being controlled. …in other words, the experimental remediation schemes have been a dismal failure to date at this site.”
Some experts estimate that it will take 25 years to clean up the toxic plume. In the meantime, Azalea residents have continued to experience plummeting property values as a result of the toxic plume affecting their neighborhood. The toxic plume was only discovered last year after a News Channel 8 investigation uncovered the issue.
The FDA noted last week that Januvia, Merck & Co.’s diabetes drug, may be linked to cases of acute pancreatitis. The federal agency said there had been 88 cases of acute pancreatitis reported in those taking Januvia between October 2006 and February 2009. In 2008, Amylin Pharmaceuticals Inc.’s Byetta had also been linked to acute pancreatitis.
Acute pancreatitis is a serious disorder that can lead to an increase in mortality. Currently, there are 110 Byetta lawsuits pending in US courts.
Avandia, the popular GlaxoSmithKline’s diabetes’ drug, has been associated with a greater risk of heart attacks by a new study. Avandia had first been linked to cardiovascular side effects in 2007 when a Cleveland Clinic trial showed that those taking Avandia were at a 43% higher risk of experiencing cardiovascular problems.
“Given the accumulating evidence of harm with rosiglitazone (Avandia) therapy and the lack of a distinct clinical advantage for the drug over pioglitazone (Actos), it is reasonable to question whether ongoing use of rosiglitazone is justified in any circumstance,” noted the researchers in their study.
The FDA has admitted that it was under a great deal of political pressure to approve ReGen Biologics Inc.s Menaflex knee device designed to repair torn meniscus.
After the FDA had rejected Menaflex for its 510(K) approval process (no human clinical trials necessary) three times, two US Senators lobbied the FDA to approve the medical device. Both US Senators from New Jersey Frank Lautenberg and Robert Menendez as well as US Reps. Steve Rothman and Frank Pallone, Jr. called the FDA in 2007 and 2008 in order to encourage them to approve Menaflex. The medical device was approved in spite of 3 previous rejections.
Due in part to the media report, the FDA is now reviewing the process by which Menaflex was approved. That process may take months but will consider whether the medical device should remain on the market.
The revelation of Congressional influence at the FDA may be surprising to some since members of Congress, especially Iowa’s Charles Grassley, have been pushing for more transparency in influence peddling regarding the approval of medical devices and pharmaceutical drugs.
Earlier this month, Salix Pharmaceuticals, Ltd. received approval to begin marketing its new Metoclopramide drug to treat diabetic gastroparesis and gastroesophageal reflux disease (GERD). However, unlike the brand name version of the drug, Reglan and its earlier generic counterparts, this new metoclopramide drug will be required to carry the strongest FDA warning, a black box warning which advises physicians about the drug’s dangers and association with the permanent movement disorder tardive dyskinesia. The new drug will also advise physicians and healthcare professionals that the drug should not be taken for a period longer than 12 weeks to avoid any onset of the neurological disorder tardive dyskinesia.
Earlier versions of the drug did not carry such a warning and patients that have contracted the permanent disorder have filed Reglan lawsuits against the manufacturers of both Reglan and the various generic equivalents known as metoclopramide.