TOV Injury and Safety Blog

Falsely marketing Zyprexa

The New York Times reported today the the U.S. government and Eli Lilly, the manufacturer of Zyprexa, are close to reaching a deal to settle civil and criminal charges against the company for illegal "off-label marketing".  The drug has only been approved for the treatment of schizophrenia or severe bipolar disorder, and apparently it is very effective in that role.  Not satisfied with the performance of its best-selling drug in that role, however, Lilly reportedly attempted to market the drug to doctors as a treatment for  mild bipolar disorder and for dementia.  Although a drug, once approved, may be utilized by a physician for any purpose, it is illegal for the manufacturer to purposely market the drug for unapproved purposes.

Concussion and post-traumatic stress in returning Iraq veterans

This week the New England Journal of Medicine released the results of a large study examining head injuries and post traumatic stress in Iraq veterans.  According to the Journal's numbers, one of six combat troopers returning from Iraq reported  suffering a concussion during his or her tour.  The numbers also showed that the fact of suffering even a mild concussion put the troopers at higher risk for suffering post-traumatic stress syndrome.

More evidence of contamination in Chinese drug ingredients

  The New York Times reported on January 31 that Shanghai Hualian, a subsidiary of the state-owned conglomerate Shanghai Pharmaceutical Group, had been identified as the operator of a factory that produced contaminated leukemia drugs.  The drugs were contaminated with a third cancer treatment chemical, vincristine sulfate, and caused paralysis in nearly 200 Chinese patients who received it.  Apparently approximately one-half of the leukemia patients have suffered permanent paralysis.

The same company has declared its intention to sell half a dozen other chemicals in the United States, although the FDA would not confirm that fact.  It also is the sole manufacturer of the drug RU 486, mifepristone, the so-called "abortion drug"for the American market.  The latter drug is manufactured at a different facility which was reportedly inspected by the FDA in May.

The gender of your surgeon may affect your care?

In a somewhat surprising study published out of Columbia University, researchers attempted to assess why one in four women being treated for breast cancer do not receive radiation therapy after a lumpectomy.  The researchers noted that such therapy is consistent with the standard of care, but still neglected too often.  They identified four factors that contributed, statistically, to a women over 65 not receiving radiation:  the oldest subjects were less likely to be radiated, black women were less likely, unmarried women were less likely to receive this therapy and women outside urban areas were less likely to receive the treatment.  After controlling for these factors, however, the researchers identiifed an additional, surprising factor.  Women treated by women surgeons were more likely to receive radiation therapy than were women treated by male surgeons.  Perhaps there is an issue of communication or of empathy which negatively influences treatment decisions; regardless, it is unfortunate and should be addressed.

You may read the Ney York Times blog article Well: The sex of your surgeon may matter here.

Low back pain: Controversy over back surgery and Prodisc

The January 30 issue of the New York Times included a lengthy critique of the conflict of interest that has been uncovered with the artificial spinal disc "Prodisc".  The artificial disc sells for about $10,000.00 and has generated significant profits for its manufacturers and investors, even though Medicare and many private insurers will not pay for its use or the expensive surgery to install it.

The Times reported that it has recently come to light that the medical researcher/doctors who endorsed the Prodisc and who were involved in the study that purportedly demonstrated its effectiveness were also investors in the product.  Thus, there is substantial question whether they were neutral, objective researchers with regard to the effectiveness of the surgical installation or the analysis of the resulting data.

Worker safety in mines

  The Bush spokesman for the federal Mine Safety and Health Administration confirmed on January 28 that the Agency had failed to issue penalties for hundreds of citations issued since the year 2000. He implied that the problem had occurred in the Clinton Administration, as well, but could not provide documentation.  The preliminary data confirmed by the spokesman documented 4000 unsafe citations issued by the MSHA between January of 2000 and July of 2006, for which no penalty had been assessed. 

  The MHSA "discovered" the problem when someone attempted to confirm whether a penalty had been assessed against a negligent mine owner after a miner bled to death in a December 2005 incident.  The miner had not received first aid after his injury:  the MHSA spokesman acknowledged that the company had never been fined, but claimed that it was fined the maximum penalty of $60,000.00 on the 18th of January, 2007, after the issue was brought to the Agency's attention.

The magic haybale

   In another marvelous result-oriented, pro-insurance, typically Henry Saad opinion, this week the Court of Appeals ruled that magical hay bales are capable of appearing anywhere, at any time.   In Kerr v. State Farm, the plaintiff was badly injured after she was startled by the presence of a haybale in the middle of the freeway and attempted to avoid it. She struck the bale, left the road and hit a highway obstacle, suffering vehicular damage and  severe injuries.  Since she couldn't identify the owner of the bale of hay, she brought a claim against her own carrier, State Farm, under the pertinent section of her policy.

More on Michigan malpractice "reform" and rate increases

In recent years, knowledgeable critics have criticized Michigan malpractice insurers  for failing to reduce their liability rates in response to the draconian "reforms" of the late 80s which significantly eroded consumer rights and victims' rights.  Apparently in response to these criticisms, one Michigan insurer attempted to achieve maximum public relations value out of its recent decision to drop 2008 rates by about six percent.  American Physicians Insurance Corporation, the malpractice insurer with the largest share of the Michigan market (about 30 percent) announced a rate cut of 6.5 percent. 

Delays in the Emergency Room

  If you have health insurance and were inclined to consider yourself protected from the problems facing the increasing proportion of uninsured Americans, consider this.  A recent study undertaken through Harvard Medical School documented that the delay in obtaining treatment through an Emergency Room has increased substantially from 1997 to 2004.  Regardless of insurance status, the average wait for all patients increased from 22 minutes in 1997 to 30 minutes in 2004.  The interim for the sickest heart patients increased from 8 minutes in '97 to 20 minutes, on average.  One-quarter of those patients waited 50 minutes or more, at a time when their triage diagnosis indicated that every minute of delay could be fatal or cause permanent harm.

Counterfeit products

The World Customs Organization recently claimed that seven percent of all items traded in the world economy are counterfeit.  According to the organization, almost 200 billion dollars per year of counterfeit products will enter the United States each year.  Obviously, this creates a tremendous opportunity for consumers to be injured by unsafe and under-regulated consumer items such as tooth paste, children's jewelry, toys, pet food and drugs.  Further, the U.S. Food and Drug Administration and the Consumer Product Safety Commission are both under-funded and under-manned, as the federal budget has been stripped to provide tax savings or to fund the war in the middle East.

Experts advise consumers to attempt to protect themselves by use of the "three P trilogy:  price, place and packaging".  If the price is too good to be true, you aren't getting what you think you are.  If you are buying "out of the mainstream", you are at risk.  If the packaging looks inferior or unusual in any manner, don't trust the contents.

Breast implants and infection

Infection is a frequent basis for malpractice complaints. Unfortunately, many hospital-acquired infections are not evidence of sub-standard treatment: these "nosocomial" infections can occur without negligence and are a significant risk for all patients.  All-in-all, it is not a healthy thing to gather many sick people under the same roof, penetrate their protective skin on a regular basis, and circulate treaters among them:  if we could provide "isolated" care to everyone, infections would be less of a problem.

Nevertheless, as described elsewhere in this blog, effective steps can be taken to minimize the risk of infection, and the Johns Hopkins Checklist emphasizing simple hand-washing demonstrated very encouraging results.

A recent study reported in the Archives of Surgery documented an additional perspective on operative infection.  In a St. Louis hospital, 50 of 949 patients receiving breast reconstruction suffered an infection at the site within one year.  The infection occured with twice the prevalence among women whose reconstruction included surgical implants.  No one offered an explanation for this discrepancy, but it certainly suggests that the introduction of even a sterile foreign body may increase the likelihood of infection.  Or, then again, maybe the utilization of one additional foreign body simply increases the potential for contamination.

The controversy over fibromyalgia

   It has been decades since we have observed a medical controversy of the magnitude we see currently with fibromyalgia.  Knowledgeable and compassionate experts in orthopaedics and pain management seem to fall resolutely at both ends of the spectrum with regard to the propriety of this diagnosis.

  Fibromyalgia was defined in a 1990 medical paper as a condition, primarily affecting middle-aged women, characterized by chronic, widespread pain of unknown origin.  It frequently occurs concomitantly with other conditions such as depression and irritable bowel syndrome.  The lead author of that paper which "recognized" and defined fibromyalgia, Dr. Frederick Wolfe, director of the national databank for Rheumatic Diseases, has since changed his mind and concluded that appending this diagnosis on the pertinent symptoms is actually counter-productive for the patient.  Dr. Wolfe now believes that rather than a separate disease process, fibromyalgia instead represents a physical response to stress, depression and anxiety.  Whether a separate medical condition, or a negative reaction to other conditions, advocacy groups argue that between 2 and 4 percent of Americans demonstrate the symptoms.

The large drug companies have entered into the fray, now, however, with drugs approved for the treatment of this controversial disease.  Pfizer, for example, secured approval to sell Lyrica as a treatment for fibromyalgia, despite very very modest evidence of effectiveness in treatment.   Eli Lilly and Forest Laboratories have also sought approval from the FDA for drugs intended to treat fibromyalgia.

  Dr. Dan Clauw of the University of Michigan, who has consulted with Pfizer, thinks that the recognition of fibromyalgia as a separate disease construct will help to achieve better understanding of the condition and end the longstanding undertreatment of the disease symptoms.

  There is no test to diagnose fibromyalgia.  A survey performed by an advocacy association documented that 63 percent of patients suffered from back pain, 40 percent suffered from chronic fatigue syndrome, and 30 percent from tinnitus or ringing in the ears.  Many other symptoms, affecting fewer patients, were also identified.

  In clinical trials, Lyrica did not perform well and it caused significant side-effects.  Patients suffering from fibromyalgia, diabetic neuropathy or shingles described a 2-point drop on a ten-point pain scale, compared with a one-point drop for patients receiving a placebo.  Since many patients suffered weight gain (9 percent experienced a 7 percent weight gain in 12 weeks--a gain that appears to continue after the 12 weeks), edema, dizziness and sleepiness, FDA reviewers did not recommend approval of the drug.  They were especially concerned about weight gain with fibromyalgia, since in the 2007 survey, the average patient diagnosed with fibromyalgia stood 5 foot 4 and weighted 180 pounds. 

   Nevertheless, senior FDA officials in the Bush Administration overruled the reviewers and Lyrica was approved.  The company then ramped up its advertising, spending 79 million dollars in the next 19 months to hype the drug.  According to Dr. Wolfe, even the modest improvement in pain levels documented for Lyrica during the first 12 weeks are not sustained.   The drugs nearing approval by the other manufacturers have taken a different approach to the fibromyalgia problem:  they were developed as anti-depressants, originally, designed to increase levels of serotonin and norepinephrine.  The Lilly drug, Cymbalta, has demonstrated treatment efficacy similar to that documented with Lyrica.

Two-year's profits from failed drug?

  For two years, Merck and Schering-Plough have been delaying the release of their test results from a study of the effectiveness of their cholesterol-lowering drug, Zetia and the Vitorin pill that relies on Zetia to reduce cholesterol.  By law, manufacturers of drugs are required to disclose study results "immediately".  These manufacturers have been stonewalling the media and medical professions, claiming that that the results were not available, even though the study ended two years earlier.

  Finally, in January 2008, the results were released and they demonstrated no cholesterol-reducing effect for Zetia and Vitorin, and IN FACT DEMONSTRATED THAT ARTERIAL INFLAMMATION or "plaque formation"--the fatal element in coronary artery disease--INCREASED BY FIFTY PERCENT OVER THE COURSE OF THE STUDY in the test subjects.  Thus, the ultimate purpose for administering the drugs--to reduce the risk of heart attack and stroke caused by plaque--was NOT served by prescribing these drugs and in fact the drug worked at cross-purposes to the needs of the patients.

  Sales and advertising of the two drugs have continued aggressively during the interim and totaled 5 billion dollars in 2007.  Meanwhile, a spokesperson for Schering, Lee Davies, claimed that the two year delay was "unrelated to the negative findings" which were "unavailable" to the companies until two weeks ago.  Does anyone accept those claims?  This is unmitigated greed--hiding these disastrous study results in order to continue to maximize sales and profit.  How many patients enrolled in the study suffered stroke or myocardial infarct that would not have occurred if they were switched to an effective drug regimen?   Is this significantly different than voluntary manslaughter?  Right now 5 million people are relying on these drugs to reduce their risk of heart attack and stroke:  according to the study, it is causing their plaque to increase twice as fast as the control group!

      The patients who participated in this study were suffering from intractably high LDL or "bad" cholesterol".  Perhaps something will come from the on-going studies of the drugs to justify prescribing them.   Our unscientific analysis, however, suggests that it would be unethical to continue a patient  on this drug regimen, given these test results.  At a minimum, this study should be the catalyst to a more effective rule actually requiring the prompt disclosure of drug study data.

Problems in rural medicine

  Rural and especially rural, poor communities in the United States have always been under-served by medical professionals.  Physicians cannot earn the living in rural areas that they can earn in urban areas, and practicing a specialty in urban areas has always been more lucrative than practicing general medicine.  This problem is compounded by the high cost of higher education:  a physician who graduates with substantial debt has even less flexbility regarding where he will commence practice.

  As a result, many small towns either no longer have a hospital, or their hospital is staffed in a manner that would not be considered "standard of care" in larger metropolitan areas.  Emergency Rooms may frequently be staffed by physician assistants rather than medical specialists, and doctors have to address and manage a wider variety of medical problems.  A consultant  may not be available in sub-specialty areas and expensive testing resources (such as CT scans or MRIs) may not be readily available.

  The New York Times reported last week that this problem of under-served rural areas is becoming more acute, nationwide, and that the Governor of New York was recommending a higher Medicare payout for rural doctors to help address the problem.  Other proposals have included the creation of a medical "peace corps" system providing two years of low-cost service by young doctor volunteers, and a grant system to support it.

  In our experience, rural northern Michigan residents fully understand that they cannot expect the same quality of care that would be provided in metropolitan areas.  A u.p. juror once told us, after a mediocre trial outcome, that "If it weren't for poor medical care, we wouldn't have any."

 

A business professor regulates worker and consumer safety

    Prakash Sethi is an elderly business school professor and grandfather who has made it a personal crusade to battle against the "march to the bottom", i.e., the tendency to move manufacturing to the location where it is performed with the fewest protections and where labor can be procured with the fewest restrictions at the lowest cost.  As a result of a 1996 dispute with the Mattel Corporation over under-aged workers being abused in Mattel factories, Sethi created the International Center for Corporate Accountability at Baruch College in New York.  Ultimately, Mattel executives hired Sethi and the Institute to help them monitor working conditions in overseas Mattel factories. 

    Other toy manufacturers, such as Hasbro, have refused to actively monitor overseas manufacturing and instead have attempted to limit regulation to voluntary compliance with the "Sullivan Principles" which were created during the Apartheid era.  Sethi and the Institute created and perform a thorough audit of overseas manufacturing that guards against a multitude of abuses, including child labor, unsanitary living conditions, unsafe work conditions, noise, temperature, safety equipment, you name it.  They don't rely upon any form of self-reporting, as it has proven to be unreliable.  Now, there is pressure to apply the same principles to guard against defects and unsafe conditions in the product manufactured, as a result of the recent flood of Chinese-made product defects and recalls. 

     Since recalls can be expensive, are always embarassing to someone like Mattell, and rarely bring more than 10-30 percent of products back from the market, a significant production monitoring cost could be justified on economic, as well as public policy bases.  Other toy makers refuse to go along, however, instead relying on a public relations device to deflect criticism:  the adoption of the "Caring, Awareness, Responsible, Ethical" [ICTI CARE] voluntary standard of conduct.  The Co-
Chairman of " ICTI CARE" is the chairman of Hasbro, who was recently quoted blaming government bureaucracy for safety problems in China.  Sethi notes that CARE lacks the one quality that true regulation requires:  a disinterested, reliable third-party monitor.  He notes that the so-called ICTI CARE standards are simply one more example of an industry code that represents institutionalization of the "lowest common denominator" in safety, wages, health and standard of living.

     Keep these relative positions in mind if you ever have the opportunity to choose between a toy made by Mattel and one made by Hasbro.  At least Mattel is attempting to live by an American standard of decency:  at Hasbro, apparently, immediate profit is the sole issue.

Rejecting the life saving checklist

    Last year Johns Hopkins University published a report on a program that installed a simple five-step checklist in every ICU in Michigan.  The checklist was an attempt to protect against infection, and it reminded doctors to do simple things like wash their hands thoroughly between patients, or to don sterile gloves and gown before inserting an IV.  Past medical studies have identified a profound problem with basic sterility practices that has caused thousands of unnecessary hospital deaths.

     The Hopkins' study generated remarkable results:  within three months the rate of bloodstream infections from IV lines droppe by two-thirds.  The average ICU cut its infection rate from 4 percent to zero.  It is estimated that during the 18 months of its existence, the program saved more thatn 1500 lives and nearly 200 million dollars in medical treatment expense. 

   The Federal Office for Human Research Protection recently shut the Michigan program down, claiming that by introducing the checklist and tracking the results without patient and caregiver written consent, the study was unethical.  Hopkins was unable to duplicate the Michigan program in New Jersey and Rhode Island, as had been planned.  As medical ethicist and writer Atul Gawande noted, the federal government's decision threatens to improperly elevate theoretical scientific ethics above actual ethical medical care requirements.

Hospital response to cardiac arrest

    A recent study involving more than 6500 patients at 369 hospitals showed that many lives could be saved if all hospitals responded appropriately to a patient's heart-stoppage.  Frequently, such a stoppage can be addressed through the immediate application of electical shock with a defibrillator.  Widely available in many environments, defibrillators can restore normal cardiac electric function immediately and if the underlying systemic condition is then addressed, the patient can survive the incident.  Hospitals call responding to this kind of an incident a "Code Blue" and they have protocols for rapid response with a properly-stocked "crash cart" and trained personnel.

   The New England Journal of Medicine found a widely divergent outcome in "shockable" abnormalities in heart rhythm.  According to the authors, the electric shock needs to be administered within two minutes to be effective.  They found, unfortunately, that in thirty percent of all cases, the shock could not be administered that quickly.

     While 39.3 percent of shockable patients survive to be discharged if they are defibrillated in a timely manner [within two minutes], only 22 percent survive if the shock is delayed.   Such delays are most likely to occur if the abnormality occurs at night or on the weekend, if it occurs in a hospital with fewer than 250 beds  or in a unit without cardiac monitors, or if it happens to a patient who was not admitted for an identified cardiac problem.  The authors noted that since the study involved patients from hospitals who had agreed to a national registry for cardiac arrest, it is likely that the results reported are better than the actual average accross the country.  Since these hospitals were already attempting to meet a higher standard in cardiac care, it is likely that they address cardiac incidents better than the average hospital which is not participating in the national registry.

      The authors point out that betwen 370,000 and 750,000 hospital patients suffer cardiac arrest and are resuscitated each year.  Between one-third and one-half are caused by arrhythmias that could be successfully treated with electric shock.  Thus, the study suggests that more than 30,000 theoretically "preventable" deaths occur each year to hospitalized patients.

The danger of not having health insurance

  Two new studies demonstrate even more forcefully that not having health insurance has a dramatic impact on health and wellness.  The studies were published by the influential Journal of the American Medical Association (JAMA) and Harvard Medical School, and by the American Cancer Society.  Together they documented that because they cannot afford appropriate screeing  and effective treatment, uninsured Americans have significantly poorer outcomes from cancer, coronary artery disease, and diabetes.   The Harvard/JAMA study correlated the health of uninsured near-retirees with insured near-retirees and with elderly Americans who have universal coverage through Medicare.  The decline in health of uninsured Americans as they approached retirement showed dramatic improvement when universal coverage became available to them.

Don't bother making your property safe for customers

    In another example of the mis-use of the "open and obvious" doctrine, the Court of Appeals in Cameron v. Big Boy applied the Supreme Court's prior holdings to immunize a restaurant from paying for the damages it caused to a patron who was entering.  The patron entered the front door on January 2 and fell in the commmon foyer on a wet floor tile. The injured customer said he did not notice a wet floor sign, because as he entered, his attention was immediately drawn to a leak in the ceiling above the door.

    The Court conceded that the restaurant owed its customer a duty to maintain the restaurant in a "reasonably safe condition", but held that simply putting a sign in the foyer was more than adequate--since the wet floor was an "open and obvious" hazard.  The patron was free to turn around and leave and should not have been distracted by any other factors:  if he was distracted, a "casual observer" would not have been, according to the Court. 

     Since a reasonable "casual observer" would have been alerted to the "TREACHEROUS" CONDITION,  the Restaurant was under no duty to fix it or alleviate the hazard.  Yes, the Court  actually held that maintaining a "treacherous" condition is consistent with a duty to maintain a "reasonably safe" premise.