Following published reports and extensive media coverage regarding egregious behaviors in the medical profession, public awareness of physician and hospital errors has increased. Despite that increased attention, data suggests that the rate of reporting by physicians is lower than it should be.

In the JAMA July 14 issue, one of the major themes covered was research articles and commentary on the Physician Peer Review process and its effectiveness. The medical peer review is the process by which a committee of physicians examines the work of a peer and determines whether the physician under review has met the accepted standards of care in rendering medical services. This process is put in place specifically to assure physicians that their statements will remain confidential when commenting on the behaviors of their colleagues (many of whom are a physician’s primary referral sources).

An original research study titled “Physicians’ Perceptions, Preparedness for Reporting, and Experiences Related to Impaired and Incompetent Colleagues” found that overall, “…physicians support the professional commitment to report all instances of impaired or incompetent colleagues in their medical practice to a relevant authority; however, when faced with these situations, many do not report.

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A well-site leader and BP employee testified before the US Coast Guard investigatory committee that there was a problem with a safety device on the drilling rig; he reported the problem; but drilling presumably continued in a complete disregard for any attention to the problem.

Ronald Sepulvado testified that he reported a problem with the control pod connected to the blow-out preventer and could not understand why drilling continued or the company ignored his report. Ironically, Mr. Sepulvado was not on board the rig at the time of the explosion because he was attending a blow-out preventer safety training program.

The best guess is Mr. Sepulvado is talking about the shuttle valve located inside the Blind Shear Ram on the drilling pipe. The operation of this unit, as well as the entire component, is superbly illustrated on the New York Times website. Once again, the Times provide wonderful insight into this issue.

A failure of the shuttle valve can result in a malfunction of the blind ram shear. Imagine the drill pipe going down to the well head at the bottom of the ocean and on the well head is a hydraulically activated set of arms that, in the event of an emergency, should activate to cut the drill pipe, crimp the end of the pipe where oil flows and create a seal to prevent oil from blowing out into the entire Gulf.

Illustration Courtesy of NY Times Website

The Blow-out preventer can be activated in essentially (4) ways:

• Electrical Control Signal: sent from the surface through a control cable;
• Acoustical Control Signal: sent from the surface based on a modulated/encoded pulse of sound transmitted by an underwater transducer;
• ROV Intervention: remotely operated vehicles (ROVs) mechanically control valves and provide hydraulic pressure to the stack (via “hot stab” panels);
• Deadman Switch / Auto Shear: fail-safe activation of selected BOPs during an emergency, and if the control, power and hydraulic lines have been severed.

In the United States waters, oil rig operators such as BP and owners, such as Transocean, are permitted to outfit the rigs with only electrical controls, avoiding the deployment of acoustical controls. The omission of acoustical controls transmits into a savings of up to $500,000 per unit. Since rigs sometimes require replacement of these units, omitting the acoustical control can actually result in even more savings.

We can only reflect and wish that BP or Transocean had seen the wisdom of employing all of the safety mechanisms available to have avoided this disaster or that BP had listened to the voice in the wilderness of its own employee, Ronald Sepulvado.

Utility vehicles are used in many rural and suburban areas for transportation and recreation, with families trusting manufacturers to keep their loved ones safe while riding on these devices. However, there are currently several hundred individual lawsuits pending against manufacturer Yamaha for their Rhino ATV product that is the “poster child” for instability and rollovers under normal usage; resulting in serious crush injuries.

These several hundred cases filed against Yamaha, relating to injuries suffered as a result of the Rhino’s instability. These cases are currently pending in federal court in Kentucky, as well as in state courts in California and Georgia. Cases filed in federal court have now been transferred to a multidistrict litigation (MDL) system which is designed to deal with large numbers of individual lawsuits regarding a specific defective product or disaster.

Currently, work is being done to prepare a number of cases for trials later this year.  These cases are known as “bellwether cases” and the trials will be conducted by the MDL judge in Kentucky as a way of resolving issues common to all cases currently filed, as well as streamlining the work that will need to be done by other federal judges to whom individual lawsuits will be referred for trial settings once the MDL’s work is complete. Judge Jennifer B. Coffman is in charge of the MDL and has scheduled a number of trials this year and next, so it is doubtful that the other cases pending in the MDL will be ripe for remands to local federal courts for quite some time.

Yamaha and its retailers are currently defending themselves in these cases with the argument that the vehicles have been misused and that drivers and passengers have ignored warnings and failed to exercise common sense while driving. We have previously written about the Rhino and why the claims of the manufacturer that consumers “misused” the vehicle are simply “smoke and mirrors” and a typical way for product manufacturers to try and delay resolving righteous claims.

A verdict was recently rendered by a jury in Gwinnett County, Georgia in the amount of $317,000 in favor of a plaintiff who suffered a serious leg injury after his Yamaha Rhino flipped over.  A previous case in another state court was lost by the injured plaintiff.  Additional cases are scheduled to be tried later this year in various state courts where the parties were able to obtain jurisdiction over the manufacturer.

Do we have the perfect storm for an environmental catastrophe leading to an economic disaster? As the oil spill continues to grab headlines, Gulf coast leaders worry about the jobs and economic stimulus provided by the oil and gas industry.

Although releasing their fury on BP over the spill and its calamitous ecological effects, Louisiana politicians are promoting the oil and gas industry in its efforts to preserve offshore drilling against Washington’s efforts to place a moratorium on it.

Why? The oil and gas industry in the gulf accounts for nearly 1/3 of the nation’s domestic crude oil production, billions of dollars in revenue and is an essential economic backbone of the Gulf States economy. Balancing that dependence with tar balls washing up on shore lines, visions of oil-soaked animals and contaminated marshes against this loss of livelihood and a dreadful “Catch-22” situation emerges.

In response to rising public anxiety regarding offshore drilling, Interior Secretary, Ken Salazar, issued a new moratorium on deepwater drilling in the Gulf. The moratorium extends over the next four months in an effort by the administration to side-step judicial objections of a six month moratorium overturned by the federal court.

The moratorium would stop over 33 existing drilling projects in the Gulf and prevent new permits for offshore drilling. This would effectively, at least in Louisiana, leave over 100,000 workers unemployed. The ban on drilling could result in lost wages for employees of the drilling projects because offshore vessels and portable rigs will be diverted to other oil-rich areas in the world. Because of this, an understandably desperate Louisiana government has been opposed to the moratorium.

A temporary cap was placed on the leak on July 15, 2010 and, after nearing 90 days, oil has stopped gushing (temporarily). Presently, no significant additional oil is leaking from the well into the gulf. Scientists are testing the oil well to investigate where the leak needs to be permanently fixed. The best case scenario for BP is that the well will simply remain successfully capped. Currently, tests are being conducted by BP to find a permanent solution to capping the well.

Scientists are also trying to accurately assess how much oil has been spilled into the Gulf and how much more could be spilled. If the well is permanently capped, we will never know how much oil still remains in the well. Scientists working on the concealment of the well are aware of hurricane season and worry that it could stall any permanent fixes to the well. Out in the gulf today, there is an armada of coast guard vessels, skimmers, and other research vessels within a six mile radius.

Gulf citizens are cautiously optimistic about BP’s temporary cap on the well, but they are understandably distraught about the economic tidal wave they may now face.

What should be done to balance environmental interests against people’s livelihoods? Can we reach such a precarious and inapposite balance?

Is this perfect storm avoidable?

Hearings have been occurring in connection with the investigation of the Deepwater Horizon explosion and the Gulf Oil Disaster. Hearings have been held in New Orleans jointly by the Coast Guard and the Bureau of Ocean Energy Management.

Many of the revelations coming out of the testimony at the hearings are interesting, but witnesses who have refused to appear or those who have been reticent to testify on certain matters are also of note.

A BP lawyer testified that the Deepwater Horizon had 390 “past due” maintenance items that should have been corrected and, which were found during a September 2009 audit of the rig. The lawyer testified that the corrections would have required 3,545 man hours to complete. All this data was set forth in a 30 page report submitted to the rig owner, Transocean, long before the tragic explosion on April 20, 2010.

Also testifying was Stephen Bertone, the chief engineer of the Deepwater Horizon rig. He testified that (8) months before the explosion the rig’s propeller that assisted in maneuvering the rig had been “having problems”. Bertone could not recall how many of the 390 deficiencies on the oil rig had been corrected before the explosion and subsequent oil spill.

Bertone also testified that he did not recall whether the general alarm had been bypassed, but did not recall hearing it go off. Bertone said he did not know whether the system for purging gas from the drill shack had been bypassed. This system was the one that kept gas from accumulating and what ultimately ended up igniting the massive explosion that did occur.

Stephen Bertone does recall that hours before the deadly blowout at BP’s Macondo well, a larger than normal number of crew members was gathered in the drilling control room on board the Deepwater Horizon.

“At that point I knew there was something going on, but I didn’t know what it was,” Bertone said.

The visit to the rig’s drill shack, where it was “standing room only,” took place about 5:30 pm, he said.

Later, shortly before 10 p.m., Bertone was reading in his bed when he heard what sounded like a freight train running through his room, then a boom. He felt thumping and saw the lights go out. That set up a chain of events that eventually led to a frenzied exit from the fiery rig.

Wouldn’t it be interesting to inquire with Bertone whether he may have asked, “gee, what is everyone here about” or “what’s the problem”, or hey, guys, what’s up”? Instead, all we know is he went to bed to read.

Bertone said he does recall reviewing an audit before the accident that found larger maintenance issues requiring Deepwater Horizon to go to the shipyard in early 2011 for work on thrusters, engines, seawater systems, ballast systems and drilling equipment.

Mike Williams, a subordinate of Stephen Bertone’s, suggested that some key safety functions on board the rig were set to bypass when the accident occurred.

BP’s well-site manager, Donald Vidrine, declined to testify at the hearings; reportedly due to health concerns.

So far, what we have in the testimony seems to be a frightening inventory of neglect and carelessness on at least the part of the rig operator, BP and the rig owner, Transocean. There seems to be at least some scintilla of suspicion that any of the neglected problems on the Deepwater Horizon may have cause d or contributed to this tragedy. There also seems to be some concern that memories are not as sharp as maybe we had hoped or honesty is in short supply.

New studies show that hospital deaths increase sharply in July causing a “July Effect”. The study illustrates the need for patients to practice caution while accepting medical care in that month or over the weekend days.

A recent study by the University of California at San Diego demonstrates that fatal medication errors rose 10 percent in July at teaching hospitals in the United States. This “July Effect,” doesn’t seem to mean that hospital staffs are running amok, but that more medication errors seem to be the culprit in teaching hospitals. The study investigated more than 62 million U.S. death certificates between 1976 and 2006. Of those, 244,388 deaths were caused by medication errors in hospitals such as dispensing the wrong medications, overdoses, and accidents involving drugs or biological agents.

The researchers examined certificates of inpatients, outpatients, and those who died in the emergency department, in which medication error was recorded as the primary cause of death. Counties containing teaching hospitals experienced a 10 percent rise in fatal medication errors in July, whereas counties lacking teaching hospitals did not experience that spike.

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The FDA announced yesterday, July 15, 2010, that a class of drugs known as ARBs (Angiotensin-receptor blockers) is being reviewed after a recent study found an increased risk of cancer associated with their use.

ARBs (Angiotensin-receptor blockers) are regularly prescribed for the treatment of hypertension (high blood pressure), diabetic nephropathy (kidney damage due to Diabetes) and congestive heart failure. Some of the more common brand names of ARBs include Diovan (valsartan), Cozaar (losartan), Avapro (irbesartan), Benicar (olmesartan) and Micardis (telmisartan).

The study cited by the FDA was conducted by a team of researchers, led by Dr. Ilke Sipahi, from the University Hospitals Case Western Medical Center in Cleveland. The team synthesized newly available data from other large scale clinical trials to look for a correlation between cancer development and the use of these drugs. The study concluded that “patients randomly assigned to receive ARBs had a significantly increased risk of new cancer occurrence compared with patients in control groups… Among specific solid organ cancers examined, only new lung-cancer occurrence was significantly higher…”[1] showing the possible cancer risk that could follow the use of this class of drugs.

The FDA plans to continue their review of these studies to determine additional information about any increased risks associated with the use of these medications.  They will release any additional information to the public as it becomes available.  At this time, they recommend that healthcare professionals and their patients continue to use these medications as their respective labels advise, but caution the community to stay alert to the possibility of the associated risks.  It is important that anyone using these medications continue with their use unless otherwise advised by their physician.

Healthcare professionals or patients taking these medications are encouraged to any report adverse events or side effects related to their use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

The FDA panel of 33 medical experts recommended that Avandia remain on the market. This decision was made even though Avandia and the clinical trials conducted about the drug are shrouded in suspicion and doubts about the impartiality of results.

The FDA panel, however, was anything but unanimous. Only 17 members voted in favor o fallowing Avandia to remain on the market, but requiring additional “black box” warnings about the drug. . This successfully permits Avandia to remain on the market for use in the treatment of diabetes. Three experts wanted to, essentially, do nothing and allow Avandia to remain on the market without further warnings. A dozen of the medical experts voted to recall Avandia.

The FDA can choose to follow the recommendations or can choose to take other action; the committee’s recommendations are not binding.

For now, if you are taking Avandia, consult with your physician regarding the decision to stay on the drug. Never discontinue taking a drug without first consulting with your physician and getting their advice.

Internal documents obtained by the New York Times reveal that not only did GSK know of the cardiac risks associated with its drug as soon as Avandia was introduced in 1999, but that it fought intensively to keep those risks from becoming public.

According to the Times, in the fall of 1999 SmithKlineBeecham (who merged with Glaxo Wellcome in 2000 to form GSK), secretly began to study whether its creation or a competing pill, Actos, was safer for the heart.

What SKB learned at that time was that not only was Avandia not better than Actos, but that Avandia was riskier to the heart.  Company executives quickly began describing the studies as “way under the radar,” and senior management directed that “these data should not see the light of day to anyone outside of GSK,” it is no wonder that the consumer and the FDA did not know discover the dangers of Avandia until recently — GSK buried it.

Why bury dangers such as these? The reason should surprise no one: money, and lots of it.  An internal document recovered by the Times estimated a loss of $600 million dollars between 2002 and 2004 alone if Avandia’s cardiovascular safety risk intensified.  We are not talking small profits.

Even to those willing to give corporations the benefit of the doubt, individually, the meaning of this revelation is impossible to ignore – $600 million dollars in our pockets or the health and safety of worldwide consumers?  And to make matters worse, GSK has a history of hiding data.  In 2004, it was found that GSK had hidden data that showed that its drug Paxil led children and teenagers to have more suicidal thoughts and behaviors For this corporation and most in the pharmaceutical industry (where hiding results of negative clinical trials was fashionable), the choice they have really is that simple: profits or safety — and safety lost.

At least two medical studies on the anti-diabetic drug Avandia (rosiglitazone) suggest that the drug is related to an increased risk of death or disability from heart attack or stroke. In fact, days ago an FDA physician and a leader in the FDA’s cardiovascular division, Dr. Thomas Marciniak, blasted one of GlaxoSmithKline’s trial studies as “inappropriate and biased”.

Dr. Marciniak continued to criticize GlaxoSmithKline’s trial, called RECORD, by stating that it cannot be trusted because of study design and conduct biases that leave estimates of cardiovascular risk of a lower boundary, rather than precise explanation.

In a presentation related to Dr. Marciniak’s findings, he includes a complete analysis of the RECORD study and, frankly, makes an excellent point for suspicion concerning the studies conducted or funded by GlaxoSmithKline:

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