Hadcorp: Surgeon found guilty of abuse

[Guest guest]

These are a number of interesting articles from Hadcorp . . .

It blows my mind to see how incompentent this country has become!

Rogene

----- Forwarded Message ----From: "humanadjuvantdisease@..." humanadjuvantdisease@...Surgeon found guilty of abuse The Gazette (Montreal) Quebec, Canada Published: Thursday, June 19 Quebec's professional order of physicians has ruled a Montreal plastic surgeon is guilty of derogatory, abusive and sexual acts toward three patients. In a decision made public yesterday, the disciplinary committee of the Collège des médecins du Québec ruled Marc Bissonnette violated the medical code of ethics by touching patients inappropriately while they were sedated at his Sherbrooke St. E clinic in the Mercier/Hochelaga/Maisonneuve

borough. The patients brought complaints to the Collège after incidents in 2002 and 2003. The first woman said she woke up during a breast augmentation surgery to find the doctor had his fingers in her vagina. The second patient reported a similar occurrence twice during the same operation when she was getting her breast implants replaced. The third patient testified she was touched inside her underwear while she was undergoing an operation to stitch a cut to her hand. Each incident lasted a few seconds, the patients said. The committee ruled that despite Bissonnette's claims the sedatives used can cause hallucinations, it was extremely unlikely three patients could have such similar hallucinations. The committee also ruled Bissonnette violated medical ethics by using general anesthetic outside a hospital setting. Bissonnette's punishment will be determined at a later hearing.

MEDICAL DEVICE NEWS

Lawsuit: Implant placed without consent Surgeon disputes claim; clinic owner concedes FDA guides weren't followed Gruchow June 17, 2008 Sioux Falls Argus Leader Sioux Falls, SD, USA A Sioux Falls woman claims a medical device was implanted in her neck contrary to federal approval and without her knowledge, and she is suing a local surgeon because of medical complications. Dr. Wellman of Sanford Clinic Neurosurgery & Spine inserted a device called Bone Morphogenic Protein, or BMP-2, in Laurie DeNeui's neck in October 2005 without her consent, according to court documents. Wellman inserted the device during surgery to treat severe headaches and neck pain, said Steve , DeNeui's lawyer. Wellman denies any wrongdoing. BMP-2 is not approved by

the U.S. Food and Drug Administration for use on the spine in the neck. It is approved by the FDA for use in the lower back to stimulate bone growth. The surgery happened at Sioux Falls Neurosurgical Associates, which has since been bought by Sanford Health and renamed Sanford Clinic Neurosurgery & Spine. Mark ston, vice president of corporate communications for Sanford Health, said the health system is not a part of the lawsuit because the alleged incident happened before it bought the clinic. He also said Wellman is a trusted doctor. "Dr. Wellman is a talented surgeon with a history of quality patient care," he said. The lawsuit, filed in November, also involves Dr. Asfora, who owned the clinic at the time and still practices there. In a separate incident, Asfora recently was warned by the FDA for mishandling a device study. DeNeui has suffered symptoms including difficulty breathing, turning her

head and speaking, her lawyer said. "As a result, she is totally disabled," said. Wellman did nothing wrong, according to one of his lawyers, Hinton. She said she could not go into detail about the case. "We are confident that when and if the case makes it to a jury, they will find that Dr. Wellman's care was appropriate," she said. Jury selection and a trial might begin after Aug. 1, said. In their response to DeNeui's complaint, lawyers for Wellman and his clinic acknowledge that BMP-2 is not approved by the FDA for how he used it and that DeNeui had difficulty breathing, swallowing and speaking after surgery. During a May 7 deposition in the case, Asfora said neither he nor Wellman read the directions or warnings sent by BMP-2's manufacturer, Medtronic, said. "I usually don't read anything the company puts out," Asfora said in the deposition. DeNeui did

not realize that she had been given BMP-2 until she went to see a Minneapolis doctor, said. Hinton said Wellman denies that allegation. "And we anticipate we will be able to present testimony that Dr. Wellman did everything that he needed to do to obtain her informed consent," she said. Using a device or drug for a purpose that is not FDA-approved is called using it "off-label." Medical doctors have wide discretion in their use of both drugs and other products off-label, said Margaret Hansen, executive director of the South Dakota Board of Medical & Osteopathic Examiners, in an e-mail. "And an example would be a medication that is 'approved' for inflammation may turn out to have an 'off-label' use of pain relief," she said. Though the board does not have jurisdiction over hospitals' and other health care agencies' off-label uses, the board could get involved should a complaint be filed against

someone licensed through the state, Hansen said. Wellman is licensed through the state, but Hansen said she is not aware of the case. She said she has asked the FDA about the off-label use of medications and other products, and the FDA has responded that such use is considered the "practice of medicine" and not regulated by them. The FDA did not respond to requests for comment. Though he did not perform DeNeui's surgery, Asfora participated in the deposition because he owned the clinic at the time. In a separate incident, Asfora received a warning letter in April for failing to properly enroll patients, report medical complications and maintain research records in an independent device study. He blames the paperwork problems on the study's monitor, who was fired.

Blood in the water: Acacia sues Boston Scientific and Medtronic By Joe Mullin June 19, 2008 Boston Scientific has taken two big hits already this year, both in E.D. Texas; most recently, a jury ordered it to pay $250 million to its rival Medtronic, the third largest patent verdict this year, according to Bloomberg News. In February, it was ordered to pay an eye-popping $500 million to an inventor. (That would be #1.) Those giant payouts for medical-device lawsuits have left blood in the water. Just two weeks after the $250 million verdict, patent-holding company Acacia Research has launched an attack on both Boston Scientific and Medtronic, accusing them both of infringing patent no. 5,254,097, related to catheters. Acacia set up shell company

Cardio Access, LLC to pursue this lawsuit, filed two weeks ago. Cardio Access LLC v. Boston Scientific Corporation et al, 08-cv-231, E.D. Texas. Boston Scientific, Medtronic, and & have been waging patent litigation battles around the country over various patents on stent and catheter technology. (So you can file this one under "living by the sword.") This patent was originally held by a smaller medical company, New Jersey-based Datascope Corp., and was sold to Acacia in January, according to PTO records. Acacia typically uses a model of splitting licensing revenue with inventors, so Datascope likely has some skin in this game. (But to be clear, I don't know that.) Datascope lost a patent infringement lawsuit brought by s Hopkins University and Arrow International, Inc. in June, which resulted in a injunction against a product it sells; then was hit with another suit in December, according to SEC records.

So perhaps they'd like to be on the other end of one of these high-value suits. Two days after the Cardio Access lawsuit was filed, the company announced it's acquiring an Italian stent business that includes a patent portfolio.

BIG PHARMA

Bad news for Big Pharma: Gamers may not be addicts Globe and Mail Canada Chad Sapieha, June 13, 2008 at 11:04 AM EDT Research carried out by an Australian psychology graduate student into the concept of video game addiction has found “that gaming doesn't cause social problems, and social problems are not driving people to gaming.” This flies in the face of the common perception that excessive gaming stunts the growth of players' social skills. The ongoing discussion among members of the American Medical Association regarding whether to make video game addiction a clinical condition reminds me of the debate regarding whether obesity ought to be classified a diagnosable disease. An excellent article that ran in issue 14.10 of WIRED magazine

cast doubt on the idea that obesity is a sickness and shed light on the process by which possible conditions become labelled official diseases—a process heavily influenced by Big Pharma. “What is a disease?” writes author Goetz. “For the pharmaceutical industry, it's a business model. Disease offers an opportunity to develop and market drugs that help people get better and, along the way, help companies make a profit.” So, more officially recognized diseases and disorders means merrier drug companies. With this in mind, the vaguely defined and poorly understood concept of video game addiction seems a perfect condition to be targeted for elevation to official affliction status. And, indeed, psychopharmacological cocktails are already being administered to treat it. I can't claim to know whether excessive game playing meets the medical requirements to be classified a psychological addiction. However, it

would seem a nebulous affliction at best, with the potential for plenty of false diagnoses brought on by parents concerned over reports they've read about people dying from exhaustion while playing an online game. All I suggest is that, before giving video game addiction our society's stamp of approval and prescribing behaviour altering medications to avid players, the interests of all concerned parties should be taken into account.

GULF WAR SYNDROME

IRAQ: 'Special Weapons' Have a Fallout on Babies By Ali al-Fadhily and Dahr Jamail* Inter Press Service Rome, Italy FALLUJAH, Jun 12 (IPS) - Babies born in Fallujah are showing illnesses and deformities on a scale never seen before, doctors and residents say. The new cases, and the number of deaths among children, have risen after "special weaponry" was used in the two massive bombing campaigns in Fallujah in 2004. After denying it at first, the Pentagon admitted in November 2005 that white phosphorous, a restricted incendiary weapon, was used a year earlier in Fallujah. In addition, depleted uranium (DU) munitions, which contain low-level radioactive waste, were used heavily in Fallujah. The Pentagon admits to having used 1,200 tonnes of DU in Iraq thus far. Many doctors believe DU to be the cause of a severe increase in the incidence of cancer in Iraq, as well as among U.S. veterans who

served in the 1991 Gulf War and through the current occupation. "We saw all the colours of the rainbow coming out of the exploding American shells and missiles," Ali Sarhan, a 50-year-old teacher who lived through the two U.S. sieges of 2004 told IPS. "I saw bodies that turned into bones and coal right after they were exposed to bombs that we learned later to be phosphorus. "The most worrying is that many of our women have suffered loss of their babies, and some had babies born with deformations." "I had two children who had brain damage from birth," 28-year-old Hayfa' Shukur told IPS. "My husband has been detained by the Americans since November 2004 and so I had to take the children around by myself to hospitals and private clinics. They died. I spent all our savings and borrowed a considerable amount of money." Shukur said doctors told her that it was use of the restricted weapons that caused her children's brain

damage and subsequent deaths, "but none of them had the courage to give me a written report." "Many babies were born with major congenital malformations," a paediatric doctor, speaking on condition of anonymity, told IPS. "These infants include many with heart defects, cleft lip or palate, Down's syndrome, and limb defects." The doctor added, "I can say all kinds of problems related to toxic pollution took place in Fallujah after the November 2004 massacre." Many doctors speak of similar cases and a similar pattern. The indications remain anecdotal, in the absence of either a study, or any available official records. The Fallujah General Hospital administration was unwilling to give any statistics on deformed babies, but one doctor volunteered to speak on condition of anonymity -- for fear of reprisals if seen to be critical of the administration. "Maternal exposure to toxins and radioactive material can lead to

miscarriage and frequent abortions, still birth, and congenital malformation," the doctor told IPS. There have been many such cases, and the government "did not move to contain the damage, or present any assistance to the hospital whatsoever. "These cases need intensive international efforts that provide the highest and most recent technologies that we will not have here in a hundred years," he added. The International Committee of the Red Cross (ICRC) expressed concern Mar. 31 about the lack of medical supplies in hospitals in Baghdad and Basra. "Hospitals have used up stocks of vital medical items, and require further supplies to cope with the influx of wounded patients. Access to water remains a matter of concern in certain areas," the ICRC said in a statement. A senior Iraqi health ministry official was quoted as saying Feb. 26 that the health sector is under "great pressure", with scores of doctors killed, an exodus

of medical personnel, poor medical infrastructure, and shortage of medicines. "We are experiencing a big shortage of everything," said the official, "We don't have enough specialist doctors and medicines, and most of the medical equipment is outdated. "We used to get many spinal and head injures, but were unable to do anything as we didn't have enough specialists and medicines," he added. "Intravenous fluid, which is a simple thing, is not available all the time." He said no new hospitals had been built since 1986. Iraqi Health Minister Salih al-Hassnawi highlighted the shortage of medicines at a press conference in Arbil in the Kurdistan region in the north Feb. 22. "The Iraqi Health Ministry is suffering from an acute shortage of medicines...We have decided to import medicines immediately to meet the needs." He said the 2008 health budget meant that total expenditure on medicines, medical equipment and ambulances would

amount to an average of 22 dollars per citizen. But this is too late for the unknown number of babies and their families who bore the consequences of the earlier devastation. And it is too little to cover the special needs of babies who survived with deformations. (*Ali, our correspondent in Baghdad, works in close collaboration with Dahr Jamail, our U.S.-based specialist writer on Iraq who has reported extensively from Iraq and the Middle East). (END/2008)

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