Sheng Cycle

Purdue Pharma, is brought down by authorities for victimizing patients around the country for encouraging physicians to over-prescribe OxyContin and making false claims about its risk of addiction — so says news reports.

The maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty Thursday to misleading the public about the drug’s risk of addiction, a federal prosecutor and the company said.

Purdue Pharma L.P. and the executives will pay $634.5 million in fines, U.S. Attorney John Brownlee said in the news release.

The plea comes two days after the Stamford, Conn.-based company agreed to pay $19.5 million to 26 states and the District of Columbia to settle complaints that it encouraged physicians to overprescribe OxyContin.

“With its OxyContin, Purdue unleashed a highly abusable, addictive, and potentially dangerous drug on an unsuspecting and unkowing public,” Brownlee said. “For these misrepresentations and crimes, Purdue and its executives have been brought to justice.”

Other shocking revelations filled in a whistle-blower lawsuit against Purdue Pharma were:

Purdue Pharma gave its sales representatives incentives to sell big quantities of OxyContin, and the sales teams encouraged physicians to prescribe the drug by taking them on expense-paid trips.

OxyContin is also known as “Hillbilly Heroin” for its sometimes lethal addictive qualities.

Source

03/30/2007

Novartis AG will stop selling a Zelnorm, a drug to relieve constipation, after it was linked to a higher chance of heart attack, stroke and worsening chest pain that can become a heart attack, federal health officials said Friday.

The FDA requested the drug be removed from the market, this was confirmed in a FDA public health advisory.

Zelnorm, also called tegaserod maleate, is a prescription medication approved for short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 with chronic constipation, the FDA said.

Doctors were warned that if they prescribed Zelnorm to patients that they should work with their patients and transition them to other therapies as appropriate, the FDA added.

Earlier this year, Novartis gave the FDA the results of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The analyses showed 13 of 11,614 patients given Zelnorm had serious and life-threatening cardiovascular side effects, while just one of the 7,031 patients given dummy pills did, the FDA and Novartis said in separate statements.

FDA officials described the cardiovascular side effects as “a very rare event.” Still, “we concluded the benefits of this drug no longer outweighed the risks for patients,” said Dr. John K. Jenkins, director of the FDA’s Office of New Drugs.

However, Public Citizen, a consumer advocacy group, said that there were 2.13 million prescriptions issued for Zelnorm in 2005 alone, making it one of the top 200 drugs in the country. The organization also said that it had warned the FDA in 2001 not to approve the drug for safety reasons.

“Once again, the FDA has approved a drug with marginal effectiveness in the face of serious questions about its safety – putting at risk the millions of people who have already used it,” said Dr. Sidney Wolfe, director of Public Citizen’s health research group.

Source: http://seattlepi.nwsource.com/health/1500AP_FDA_Constipation_Drug.html

Complications of Anterior Discectomy – which side is better to operate on? The left or the right side of the neck?

Well, it appears based on the study below that each side of the neck is equally risky for complications.

Effect of approach side during anterior cervical discectomy and fusion on the incidence of recurrent laryngeal nerve injury.

OBJECT: This retrospective study was designed to determine whether side of approach during instrumented, one- or two-level primary anterior cervical discectomy and fusion (ACDF) affects the incidence of recurrent laryngeal nerve (RLN) injury diagnosed by observation of the vocal cords (OVC).

METHODS: Records of all patients who underwent one- or two-level instrumented primary ACDF (418 patients) between January 1995 and February 2004 were reviewed.

Data collected from these charts included surgeon, patient demographics, preoperative diagnosis, side of exposure, number of vertebral levels fused, and presence of recurrent laryngeal nerve injury diagnosed by observation of the vocal cords after referral for persistent dysphonia.

Time from surgery to OVC for patients with right-sided exposures was not statistically different from that for patients with left-sided exposures.

Of 418 patients, 278 (66.5%) had right-sided exposures and 140 (33.5%) had left-sided exposures.

Eight RLN injuries (1.9%) were noted-five in patients with right-sided exposures (1.8%) and three in patients with left-sided exposures (2.1%).

The difference between right- and left-sided injury rates was shown to be nonsignificant using Fisher exact tests.

CONCLUSIONS: Results indicate that, given the study’s sample size, side of approach during instrumented, one- or two-level primary ACDF has no significant effect on recurrent laryngeal nerve injury incidence in patients with persistent dysphonia referred for observation of the vocal cords .

The definitive answer regarding the true incidence of recurrent laryngeal nerve injury relative to approach side awaits a prospective study with preoperative, immediate postoperative, and periodic OVC in a large, homogeneous population with sufficient numbers of patients with right- and left-sided approaches.

Source: Journal Neurosurg Spine. 2006 Apr;4(4):273-7.

WASHINGTON (Reuters) – More and more obese people are unable to get full medical care because they are either too big to fit into scanners, or their fat is too dense for X-rays or sound waves to penetrate, radiologists reported on Tuesday.

With 64 percent of the U.S. population either overweight or obese, the problem is worsening, but it represents a business opportunity for equipment makers and hospitals, said Dr. Raul Uppot, a radiologist at Massachusetts General Hospital.

“We noticed over the past couple of years that obesity was playing a role in our ability to see these images clearly,” Uppot said in a telephone interview.

Radiologists have their own term for it when writing up reports:

“These images are limited due to body habitus.”

Uppot’s team looked for this phrase in radiology reports from 1989 to 2003. These included standard X-rays, computer assisted X-rays known as CT scans, magnetic resonance imaging (MRI) and positron emission tomography (PET).

These scans are used to look for tumors, blood clots, broken limbs and other injuries and diseased organs.

“Overall, 7,778 or 0.15 percent of 5,253,014 reports were habitus limited,” they wrote in the August issue of the journal Radiology.

“It essentially doubled over the last 15 years,” Uppot said.
The researchers looked more closely at the records of 200 of the patients, who weighed, on average, 239 pounds (108 kg).

“It is a major issue because … the patient may still have a tumor, the patient may have appendicitis, the patient may have other inflammatory processes,” Uppot said.

“This is affecting radiologists all over the country.”

NOTHING BUT STATIC

Ultrasounds are most affected, Uppot said.

“In an obese person because the ultrasound beam does not get to the organs or get to them adequately enough we cannot get a picture. It looks like a snowstorm — I don’t know if you have seen those televisions where it is just whiteout? It looks like that.”

An MRI can get a good picture if the patient can fit into the tube or get onto the table, Uppot said. Some manufacturers have started to make MRI machines with larger bore holes, but with the cost in the millions of dollars per machine, only large groups or institutions can afford them.

Siemens Medical Solutions of Siemens AG has seen the market potential. “Increase Your Physician Referral Base with 1.5 Tesla MRI for Obese and Claustrophobic Patients” the company says on its Internet website http://www.medical.siemens.com.

“It is a market out there. People who are taking advantage of it are making money,” Uppot said. “We are in the process of buying and installing three of these machines.”

One problem is with gastric bypass surgery, where the patients are by definition obese, Uppot said.

“If there is some complication — abdominal pain or and infection or fever — they are invariably at higher risk of not being able to be imaged with a CT or MRI,” Uppot said.

“For the surgeon, he doesn’t want to take the patient back to surgery to explore to see what the problem is,” he added.

“For the patient, not knowing what is going on is a big issue. If you tell a patient ‘I am sorry — we just can’t sit you on our CAT scanner’, that is devastating to hear.”

Source: Reuters

Reports the New Diabetes Drug Pargluva is Dangerous

Generic Name : muraglitazar

A new diabetes pill that was headed for government approval has been linked to deaths, heart attacks and strokes, a medical journal reported.

The study by leading heart researchers found twice as many deaths and cardiovascular problems in diabetic adults taking the drug Pargluva as those on dummy pills or a competing drug.

Developed by Bristol-Myers Squibb and Merck & Co., the drug, known generically as muraglitazar, was endorsed by a Food and Drug Administration panel last month. It is a treatment for Type 2 diabetes, the most common form and one that occurs most often in people who are overweight.

The Journal of the American Medical Association said it posted the analysis on its Web site Thursday ahead of next month’s publication date because of public safety concerns. The study was by Cleveland Clinic doctors who reviewed data the FDA made public before the panel vote.

If the analysis is correct, the drug could have meant a “public health catastrophe” given that 18 million Americans have diabetes, said Steven Nissen, who worked on the analysis with Eric Topol and a clinic statistician.

“This is the Vioxx that isn’t going to happen,” Nissen said, referring to the painkiller Merck removed from the market last year after it was linked to serious heart problems. Nissen has done consulting work for several drug companies, including Merck and makers of other diabetes treatments, but said he does not accept fees for that work.

Critics including Nissen have accused the FDA of lax drug surveillance because of Vioxx and other recent safety issues, such as evidence linking some antidepressants with a greater risk of suicidal thoughts in youngsters.

The FDA appeared to be heading down the same road with Pargluva despite that criticism, said Catherine DeAngelis, editor in chief of The Journal.

“It is beyond me why individuals who are supposed to be overseeing the safety of the public would take a chance when it’s not necessary,” DeAngelis said.

In a news release, the FDA said it appreciated “the need for careful assessment of risk versus benefit for all drugs, particularly those indicated for long-term, preventive therapy.”

“The FDA has made significant investments of resources and expertise in developing fundamentally better methods for identifying and monitoring cardiovascular safety issues with all drugs.”

Louisiana attorney general investigating patient murders at Memorial Medical Center during Huricane Katrina

Three days after Hurricane Katrina flooded New Orleans, staff members at the city’s Memorial Medical Center had repeated discussions about euthanizing patients they thought might not survive the ordeal, according to a doctor and nurse manager who were in the hospital at the time.

The Louisiana attorney general’s office is investigating allegations that mercy killings occurred and has requested that autopsies be performed on all 45 bodies taken from the hospital after the storm.

Orleans Parish coroner Frank Minyard said investigators have told him they think euthanasia may have been committed.

“They thought someone was going around injecting people with some sort of lethal medication,” Minyard said.

Link

Did New Orleans Medical Doctor’s Intentionally Kill Hospital Patients?

A British Newspaper Says Yes!

The newspaper account details an anonymous female physician who admits that many patient murders were committed during the flood chaos.

Doctors working in hurricane-ravaged New Orleans killed critically ill patients rather than leaving them to die in agony as they evacuated hospitals, The Mail on Sunday can reveal.

The newspaper account also has others stating this barbaric tactic was used.

One emergency official, William ‘Forest’ McQueen, said: “Those who had no chance of making it were given a lot of morphine and lain down in a dark place to die.”

‘These people were going to die anyway’

“I injected morphine into those patients who were dying and in agony. If the first dose was not enough, I gave a double dose. And at night I prayed to God to have mercy on my soul.”

The doctor, who finally fled her hospital late last week in fear of being murdered by the armed looters, said: “This was not murder, this was compassion. They would have been dead within hours, if not days. We did not put people down. What we did was give comfort to the end.

“I had cancer patients who were in agony. In some cases the drugs may have speeded up the death process.

“We divided patients into three categories: those who were traumatised but medically fit enough to survive, those who needed urgent care, and the dying.

Mr McQueen, a utility manager for the town of Abita Springs, half an hour north of New Orleans, told relatives that patients had been ‘put down’, saying: “They injected them, but nurses stayed with them until they died.”

Mr McQueen has been working closely with emergency teams and added: “They had to make unbearable decisions.”

Hopefully, the Louisiana Board of Medicine or the American Hospital Association will investigate these claims. This is either a hoax put forth by the Brits or serious problem.

Source: We had to kill our patients by CAROLINE GRAHAM and JO KNOWSLEY, Mail on Sunday. 09:01am 11th September 2005

Story Update: 12 Sept 2005

An AP article from 12 Sept 2005 reports the following:

Authorities raised Louisiana’s death toll to 197 on Sunday, and recovery of corpses continued. Teams pulled an unspecified number of bodies from Memorial Medical Center, a 317-bed hospital in uptown New Orleans that closed more than a week ago after being surrounded by floodwaters.

Source: Hopelessness Begins to Lift in New Orleans

Update: 12/24/2005

Louisiana investigating euthanasia

Louisiana’s attorney general has confirmed that his office is investigating allegations that euthanasia was used to end the lives of ill and elderly patients at a hospital in the chaos that flooded over New Orleans in the wake of Hurricane Katrina.

Wartelle, the attorney general’s spokeswoman, said that 73 subpoenas have been issued in connection with the investigation and that there are “multiple persons of interest” involved in the case.

AG Investigation Patient Murders at Memorial Medical Center

Doctor under fire

President of medical society has been accused of malpractice more than any other local physician since 2004.

LANCASTER COUNTY, PA – Of 50 medical malpractice lawsuits filed here during 2004 and the first six months of 2005, six named orthopedist Anthony J. Mauriello Jr., president of the Lancaster City and County Medical Society.

No other county physician has drawn more than two suits during that time, according to records in the Lancaster County prothonotary’s office.

The earliest of the suits filed against Mauriello, in February 2004, has been dropped. The other five are active. None is yet scheduled for trial.

The suits involve three knee and two hip surgeries.

One of the patients died. Two suffered severe nerve damage. Two called on other doctors to redo their knee and hip replacements, according to the lawsuits.

Four of the five suits have been brought against Mauriello; Midstate Orthopaedics, his practice in Lancaster and Willow Street; and Lancaster Regional Medical Center, where Mauriello operated. The other suit does not include the hospital.

Asked to comment on these lawsuits, Mauriello referred a reporter to his attorney, Christopher Stump, of Stevens & Lee.

Stump said he cannot respond to individual allegations in pending lawsuits but can characterize the suits as a group.

“The fact that one lawsuit or 20 lawsuits have been filed does not mean that anyone did anything wrong,” he said.

Mauriello has had advanced training in hip and knee replacement, Stump added, so the doctor often deals with complex cases.

“All surgeries carry risks,’’ the attorney explained. “Orthopedic surgeries particularly carry risks. The majority of the surgeries involved in these lawsuits involve especially difficult orthopedic procedures that carry even higher risks.’’

Stump said “highly qualified experts’’ will review all cases and “we intend to vigorously defend them.’’

Mauriello, now 41, is a native of northern New Jersey. He graduated from Creighton University School of Medicine, Omaha, Neb., in 1993.

He did his internship at Albany Medical Center, Albany, N.Y.; his residency at Albany Medical Center, New York Medical College and St. Vincent’s Medical Center, all in New York City; and a fellowship in total joint replacement at Lenox Hill Hospital, an affiliate of New York University Medical Center, New York City.

Mauriello moved to Lancaster in 1999.

He began practicing with Orthopedic Associates of Lancaster, focusing on joint treatment. He opened his own office, Midstate Orthopaedics, in January 2001. The practice has one other doctor.

Mauriello was installed as the medical society president in June. He also has served in the Pennsylvania Medical Society House of Delegates.

Mauriello is the only Lancaster doctor who has been sued here repeatedly since the state Supreme Court required strict labeling of medical malpractice lawsuits at the beginning of 2004.

William Atlee and three other attorneys with Atlee, Hall & Brookhart filed the suits on behalf of the plaintiffs.

Here are the basic details of the five lawsuits against Mauriello, in chronological order:

· According to the complaint of a lawsuit filed March 23, 2004, by plaintiffs Kurt and Lou Ann Stoner, 3246 Blue Rock Road, Mauriello replaced Kurt Stoner’s left knee in April 2002.

Stoner, 45, complained of continuing pain and inability to fully flex his knee. That September, Mauriello manipulated Stoner’s knee under anesthesia to break down scar tissue around the surgical area, according to the complaint.

Not satisfied with his progress in therapy, Stoner contacted Dr. Paul Neuman, who redid Mauriello’s knee replacement at Reading Hospital and Medical Center in June 2003. Stoner regained full use of his knee.

The lawsuit’s complaint claims Mauriello was negligent in not properly sizing or positioning the knee replacement.

The suit seeks “in excess of $35,000’’ on each of four counts.

The first three counts charge medical negligence against Mauriello, Midstate and Regional individually. The third count specifically charges the hospital with “granting privileges to perform total knee replacement surgery to a physician who was not properly qualified to perform the procedure.’’

The fourth count charges all three defendants for causing Mrs. Stoner’s “loss of consortium’’ with her husband.

A preliminary response from defense attorney Stump questions the plaintiff’s allegations about his treatment by Mauriello and Neuman.

The defense denies that “these allegations in any way suggest that Dr. Mauriello was negligent or that revision surgery was required due to Dr. Mauriello’s care.’’

Andrew Briggs and Karen Minehan of Post & Schell, attorneys for Regional Hospital, deny all allegations of negligence, countering that “the care provided was at all times consistent with the standard of medical care in the community.’’

· In a suit filed April 20, 2004, Diane and Frank Kirsch, 649 Wyncroft Lane, allege that Mauriello operated negligently on Mrs. Kirsch’s left leg and hip three times in August and October 2002.

Mrs. Kirsch, 59, had continuing problems, so Mauriello consulted Dr. William Parrish of Hershey Medical Center. Parrish took X-rays, according to the lawsuit’s complaint, “from which it was determined that Mrs. Kirsch’s hip replacement was improperly inserted.’’

Parrish removed the artificial hip and inserted a new one.

The Kirschs seek “in excess of $50,000’’ on each of three counts.

Two counts charge medical negligence against Mauriello and Midstate individually. The third charges both for causing a loss of consortium.

In a preliminary reply to the lawsuit, the defense suggests that “plaintiffs’ injuries, if any, may be the result of a negligent act of individuals other than defendants.’’

· Lorraine Ruhl, of Lititz, filed a lawsuit on Nov. 1, 2004, following the death of her husband, Michael Ruhl, nearly a year earlier.

Ruhl, a 54-year-old construction project foreman, had elected to have a right hip replacement.

On Nov. 10, 2003, Mauriello operated at Lancaster Regional. Ruhl lost 4,500 cubic centimeters of blood, “an excessive amount of blood for this procedure,’’ according to the lawsuit’s complaint.

(A thousand cubic centimeters is equivalent to slightly more than a quart.)

Following surgery, the patient continued to lose blood and died on Nov. 12.

An autopsy concluded that the cause of death was fat emboli (fat droplets moving within blood vessels following trauma) caused by an excessive amount of blood loss and shock.

The lawsuit’s complaint charges that during the surgery Mauriello “created a situation where Mr. Ruhl lost a tremendous amount of blood and did not properly intervene to resolve the bleeding.’’

The suit further charges that neither Mauriello nor other health-care providers at the hospital “intervened to identify the cause of the blood loss and correct it until too late.’’

As a result of this negligence, according to the suit, Ruhl died.

The suit seeks “in excess of $35,000’’ on each of five counts.

Three counts name Mauriello, Midstate and Regional individually because they “negligently caused and/or allowed excessive bleeding during and/or after surgery’’ and were otherwise negligent.

A fourth count charges corporate negligence against the hospital because it allegedly failed “to properly select and retain only health care providers and staff who were competent in providing care for patients such as Mr. Ruhl.’’

That count also alleges that through its own health-care providers and staff the hospital “had actual or constructive notice that Dr. Mauriello was not properly caring for patients.’’

The fifth count charges all three defendants with inflicting emotional distress on the plaintiffs, who “witnessed the injuries caused by the loss of blood and ongoing bleeding suffered’’ by Ruhl.

Mauriello and the hospital have objected to these allegations in preliminary court filings.

Mauriello claims the patient “died of a known complication of any orthopedic surgery, a fat embolism’’ and, therefore, the plaintiffs have no basis for a suit.

Lancaster Regional says the suit against it should be dismissed because the plaintiffs have no proof of corporate negligence.

· In a lawsuit filed May 3, Marjorie and James Snare of Huntingdon allege that Mauriello, in performing a right knee replacement in June 2003, “negligently crushed and/or severed’’ nerves in Mrs. Snare’s leg, causing severe incapacitation.

The lawsuit’s complaint further charges that “Mauriello negligently failed to intervene to correct or remedy’’ the problem.

Other doctors examined Mrs. Snare, who was 72 at the time of the surgery, and recommended an ankle brace and further treatment, according to the complaint.

The suit seeks “in excess of $50,000’’ on each of five counts.

Three counts charge that Mauriello, Midstate and Regional individually operated negligently and failed to intervene with remedial action, “which placed Mrs. Snare at undue risk of serious and permanent disability.’’

A fourth count charges Regional separately with corporate negligence because, prior to the surgery, the hospital had notice of “numerous complaints and issues regarding treatment provided by Dr. Mauriello’’ and notice that Mauriello “was not properly caring for patients.’’

A fifth count charges all three defendants for causing a loss of consortium.

Mauriello has not yet replied to the suit.

Lancaster Regional’s preliminary reply denies all allegations and asserts that the hospital was not negligent.

· In a suit filed June 7, Baron and Renee Geib, of Lititz, allege that Mauriello injured a nerve and caused other damage in July 2003 while replacing Geib’s left knee.

The lawsuit’s complaint further charges that although Mauriello later discovered nerve damage, he addressed the 42-year-old Geib’s post-operative distress only by prescribing pain killers.

In January 2004, Geib sought a second opinion from Dr. Thomas Westphal. Westphal referred the patient to Dr. Jack Shilling. Both are local orthopedic surgeons.

According to the complaint, Shilling reported that Geib “had a peroneal nerve injury problem from the knee replacement surgery.’’

Shilling performed an operation to repair correctable damage, not including the nerve.

Lancaster neurosurgeon James Argires evaluated Geib on Dec. 1, 2004, according to the lawsuit. Argires concluded that Geib’s nerve damage is permanent and “this resulted from his first surgical procedure by Dr. Mauriello.’’

The plaintiffs seek “in excess of $35,000’’ on each of four counts.

The first three name Mauriello, Midstate and Regional individually for negligence in causing Geib’s “severe permanent injuries.’’

A fourth count charges Regional separately with corporate negligence &tstr; allowing Mauriello to operate although the hospital had notice of “numerous complaints and issues regarding surgeries performed by Dr. Mauriello, specifically, that Dr. Mauriello was not properly performing knee replacement surgeries and was not properly caring for his patients at Lancaster Regional.’’

A fifth count charges all three defendants for causing a loss of consortium.

Defendants have not yet replied to the substance of the suit.

Mauriello also was one of four local surgeons identified in June as having an unusually high number of complications for hip and knee replacement surgeries in 2002.

The Pennsylvania Health Care Cost Containment Council said Mauriello had a higher than expected number of device problems and patient readmissions.

Midstate Orthopaedics’ office manager explained that two of Mauriello’s patients had dislocated their joints twice and were counted as four patients.

The manager said readmission rates reflected Mauriello’s policy of replacing a patient’s knees one week apart, which is counted as a readmission.

Neck fusion surgery is becoming more common in the United States as insurance companies tend to reimburse surgeons at a higher rate for it compared with other neck surgeries.

However, neck fusion surgery has not been shown to be safer or more advantageous then non-fusion type neck surgery.

Complications such as death, infection, disability, and pseudoarthrosis are more common with neck fusion surgery.

This story is an example of two bad things happening.

1) A surgeon is alleged to have botched a neck fusion surgery causing unintended damage at other areas of the cervical spine.

2) The cover up. Hospitals and doctors are supposed to ‘first do no harm’. Unfortunately for this woman, this did not occur.

Hospital To Pay Up For Screw Left In Body

Jury Awards Woman More Than $1 Million

A jury ordered a local hospital to pay damages after a screw was left inside a woman’s body during surgery.

A verdict in the civil trial last week awarded more than $1 million in damages for Katherine Flanagan, 49, against Mount Clemens General Hospital and staff neurosurgeon Mark Goldberger, according to The Macomb Daily.

Flanagan claimed malpractice, negligence, pain and suffering, plus extensive costs for her continued care and wrongful concealment of facts about a neck fusion procedure performed on her in February 2002, where Goldberger was the operating surgeon, the paper reported.

Officials said the procedure was supposed to fuse three vertebrae in her spine, but during the surgery a screw was driven into a disk between two vertebrae above the operating area, the paper reported. When Flanagan was sewed up again, the screw was never removed and the hospital allegedly did not tell her about it.

Flanagan had it removed eight months later.

Robert F. Garvey, an attorney for Flanagan in the case, told the paper that by the time the screw was removed it had caused the disc to “deteriorate” and develop symptoms like arthritis.

Garvey told the paper that his client will likely require additional correctional surgery.

The hospital, which Garvey said rejected a mediation proposal to settle the case for $300,000 prior to trial, would not comment on details of the surgery after the verdict, the paper reported.

Jim Perpich, a spokesman for Mount Clemens General, told the paper that the hospital will continue to fight on appeal.

Surgical Tools at Two Hospitals Washed with Hydraulic Fluid

RALEIGH – Over two months last year, 3,800 patients at two hospitals run by Duke University Health System were exposed to surgery with instruments that were washed in hydraulic fluid instead of detergent, hospital regulators say.

Duke Health Raleigh (formerly Raleigh Community) and Durham Regional hospitals put patients in “immediate jeopardy” in November and December by not detecting the problem, despite complaints from medical staff about slick tools, the regulators said.

The hospitals did not fix the problem for weeks, said the report from the Centers for Medicare & Medicaid Services, which The News & Observer of Raleigh reported Sunday.

“Administrative staff failed to heed the multiple complaints of staff sterilizing and using the instruments, thus delaying the discovery of the error and needlessly exposing patients to these instruments over a longer time period,” said the report from the agency, which oversees patient care at hospitals that receive payments from federal insurance programs.

When Duke Health officials disclosed the mistake in January, they assured patients that the likelihood of infection was “no more than the risk normally associated” with the procedures patients underwent.

But seven months later, dozens of patients who were exposed to the surgical instruments are reporting lingering health problems — some minor, such as fatigue and joint pain, and others serious, requiring hospitalization, the newspaper said.

Mix-up during repair

According to the investigation reports, the mix-up originated last summer when an elevator at Duke Health Raleigh was repaired.The inspectors said that workers drained hydraulic fluid from the elevator into about a dozen empty detergent drums that they got earlier at Duke University Hospital when they fixed an elevator there. Most of the drums were marked with the brand name of a detergent used to wash surgical tools. The drums were later picked up and used as if they contained detergent (the detergent and hydraulic fluid have a similar color).

Within days, according to the investigation, staff members at the affected hospitals began complaining about greasy instruments that often left an oily yellow stain on the tray liners. On some occasions, the operating room staffs wiped down the tools with sponges because they were so slick, investigators reported.

Many patients say they have asked Duke to tell them what was in the used hydraulic fluid, a petroleum product called 32 AW manufactured by Exxon that may have picked up particles from its use in the elevator.

Luanne Williams, a state toxicologist, said other substances might have been introduced during the fluid’s use in the elevator, giving it a unique chemical composition.

Hospital statement

In response to patient requests about what was in the used hydraulic fluid, Duke has said it’s still investigating and can’t provide such details yet.

Duke Health System officials declined to be interviewed, the Raleigh newspaper reported, citing possible lawsuits.

They issued a short statement reiterating that infection rates are not notably higher than would typically be expected, and urging patients to talk with their doctors about concerns.

Thomas Henson Sr., a lawyer representing eight patients, said he is exploring whether to file a legal petition demanding that Duke reveal the contents of the hydraulic fluid.

“If Duke doesn’t have anything to hide, why are they hiding it?” Henson said. “Give me the scientific evidence that says these people are not at risk. “

Link to article:

FDA Wants Bextra Withdrawn from Market

The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. OTC, COX-2, NSAID Danger List.

“Today’s actions protect and advance the health of the millions of Americans who rely on these drugs everyday,” said Dr. Steven K. Galson, Acting Director of FDA’s Center for Drug Evaluation and Research (CDER). “FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks.”

FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the overall risk versus benefit profile for the drug is unfavorable.

FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

Interesting Facts about COX-2 Drugs.

Worldwide sales of Bextra and Celebrex were more than $5 billion last year.

In February 2005, an FDA advisory panel said Cox 2 drugs Bextra, Celebrex and Merck & Co.’s Vioxx “significantly increase” the risk of heart attack or stroke.

Regulators also want all other anti-inflammatory drugs in the same class to carry the strongest safety warning possible.

The FDA ordered over-the-counter nonsteroidal anti-inflammatory drugs to revise their labels to include information about the risks of cardiovascular incident and gastrointestinal bleeding.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency’s Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.