Monday, January 31, 2011

Is JAMA Protecting Duke Medical's Fraudulent Cancer Researcher?

Kudos to Retraction Watch: Tracking Retractions as a Window into the Scientific Process.


Remember that Duke Medical knew that Anil Potti, MD and Joseph Nevins, MD performed serious research that directed affected cancer patients at Duke Medical and throughout the country and world.  


Duke Medical has still failed to communicate to Duke cancer patients the impact of the disgraced researcher on their health.  Inexcusable, unethical - that is for each patient to decide.


Why then would Duke Medical and JAMA engage in mental gymnastics to validate research that numerous researchers could not replicate? Remember that Lancet Oncology maintained a high level of scientific integrity and retracted a previously questioned Anil Potti paper.


IMHO: Follow the money.


What did the good people at Retraction Watch determine?  Read on (with special thanks to ivanoransky)  http://goo.gl/8ZvwK


With the third retraction of a paper by Anil Potti this weekend, plus details of various investigations dribbling out, we decided to check in with the world’s two leading medical journals about whether they planned to retract the papers of Potti’s they’d published.
JAMA published two papers by Potti and colleagues: One, “Gene Expression Signatures, Clinicopathological Features, and Individualized Therapy in Breast Cancer,” appeared in 2008. It has been cited 51 times, according to Thomson Scientific’s Web of Knowledge, and was the subject of two letters. In one, a correspondent expressed concerns about the lack of information in the study about
how the biospecimens, which are the foundation of these molecular studies, were collected, transported, preserved, processed, and stored for the actual testing.
The other, “Age- and Sex-Specific Genomic Profiles in Non-Small Cell Lung Cancer,” appeared last year, and has been cited five times.
On both papers, a spokesperson told us:
The JAMA editors don’t have any information to share about that paper.  Of course, if there is a retraction, it will be noted in JAMA and online.
NEJM published “A genomic strategy to refine prognosis in early-stage non-small-cell lung cancer” in 2006 and corrected it in 2007. The study has been cited 290 times, according to Thomson Scientific’s Web of Knowledge.
A NEJM spokesperson told us:
I don’t have anything new to report.  We don’t have any plans to retract the paper.
We’ll update as we hear anything else.

Saturday, January 29, 2011

More Bad News for Duke University Medical (from the FDA)

The Science Insider (Breaking News From the World of Science Policy) is a terrific website and I thank them for sharing this article from The Cancer Letter

FDA Audits Halted Duke University Clinical Trials Data Related to Genetic Cancer Predictors –
A “Padded” Resume of Experience That Did Not Exist
January 28, 2011
The studies were carried out and then halted upon finding out that one of the biostatisticians lied about his background.  Much of the published information on the trials has now been retracted and now the FDA is looking into the situation to get additional information.  Credentials and backgrounds on qualifications are certainly creeping into the news quite frequently today.  Not too long ago a pilot even had the AMA fooled on his false credentials of being a doctor.  How do these folks do this I wonder with all of us being so connected today?  It seems like such discrepancies should be showing up sooner, that is if anyone decided to check them out. 
The fallout continues from a decision to halt controversial cancer trials at Duke University last year: In an article today, The Cancer Letter is reporting that the U.S. Food and Drug Administration (FDA) is auditing data related to the trials. The Duke genomics center run by a prominent cancer researcher, Joseph Nevins, has been disbanded, although a Duke spokesperson says that decision was already in the works and is unrelated to the FDA audit.
It's a long and winding story that dates back several years to initial queries from two biostatisticians at MD Anderson Cancer Center. They expressed concerns about the science behind genetic cancer predictors developed by two Duke researchers, oncologist Anil Potti and Nevins. After the biostatisticians contacted the Duke scientists and the journals that published their work, Duke launched trials based on the technology, using it to assign patients to different treatments. In the summer of 2010, The Cancer Letter reported that Potti had padded his resumé and claimed he was a Rhodes scholar when he wasn't. He resigned, and the trials were halted. Several papers describing the technology have recently been retracted.
http://goo.gl/4FNKv

I am not a big fan of federal government agencies.  But I am grateful to the FDA in this instance for protecting patients.

Is Your Orthopedic Surgeon Qualified to Perform Joint Replacements?

According to the Mayo Clinic, a serious risk of the joint replacement or even orthopedic surgery to repair a fracture is osteomyelitis (bone infection).  http://goo.gl/pHfmJ


Staphylococcus bacteria, a type of germ commonly found on the skin or in the nose of even healthy individuals.  The germs can enter a bone in a variety of ways, including . . . direct contamination through orthopedic surgery
Please make certain that your orthopedic surgeon know how to prevent, diagnose and treat osteomyelitis. It is basic orthopedics 101.

If I had any remote idea that Duke Orthopedics did not include "osteomyelitis" on their list of "what Duke Orthopedics can do for you," I never would have taken my dad or myself to Duke Orthopedics for treatment of this disease.

Although scanned and safely in my computer, I cannot place the current scanned version of Duke Orthopedics's list of their competencies (specifically omitting "osteomyelitis").  I save that copy for a more appropriate venue.  

Rather at this point, I share the link to "Duke Orthopedics: Patient care Services"
Note page 3 of Duke Orthopedics's stated competencies:


Occupational therapy (joint replacements)
Orthopaedic cancer 
Orthopaedic trauma treatments 
Orthopaedics (general)
Orthotics

Osteonecrosis

The space between "orthopedics (general)" and "orthotics osteonecrosis" is obvious and inconsistent with the formatting of the orthopedics conditions list.  It appears that Duke University Orthopedics removed osteomyelitis from its list of "conditions the Duke Orthopedic Surgeons can treat."

In stark contrast to Duke Orthopedics' admitted lack of competency in the field of bone infections (osteomyelitis), the pre-eminent work "Duke Orthopedic Presents - Wheeless' Textbook of Orthopedics" discusses Osteomyelitis in depth. (Last updated by Clifford R. Wheeless, III, MD on Monday, September 6, 2010 3:09 pm)  My surgery was on September 13, 2010 at about 3:00 pm.

LESSON FOR ORTHOPEDIC PATIENTS AND THEIR CARE-GIVERS:

1.  Prior to undergoing a joint replacement or any orthopedic surgery that requires your having metal (including screws or nails) placed in the bone, check the medical facilities web-site.  If there is no orthopedic surgeon with specific experience or knowledge relating to osteomyelitis than you must ask reasonable questions.  

Make certain that that surgeon feels comfortable with the field of bone infections or has a colleague who would be able to address the issue.  

2.  Please communicate with your orthopedic surgeon and discuss his views of a team approach to bone infections.  Many orthopedic surgeons do not want to involve plastic surgeons and consider infectious disease specialists as a separate issue.  Generally, it is best if the three specialties work as a team.

Protect yourself.  Infections are unnecessary,  Bone infections are insidious and can be hospital borne.


    Friday, January 28, 2011

    Don Imus is an Inspiration for Cancer Patients

    Don Imus may be the best medicine for men with cancer.


    Thank you Fox Business News Channel for making room for Don Imus.  http://www.imus.com/imus-ranch/


    Don Imus undoubtedly introduces new viewers to FBN.   But his presence on FBN serves a humanitarian purpose.  Imagine that.


    My dad (Robert W. Handy, Ph.D) was research scientist who was involved in positive homeopathic research at RTI International at RTP in NC.  Dad died from complications of colon cancer in January 2010.  The chemotherapy destroyed dad's immune system, repeated orthopedic surgeries were the most his body could handle.  Bone infections are insidious, difficult to treat in the elderly and people die.  During his illness, dad lost his dry sense of humor (much like the I-Man's), trust in people, love of life and will to live.


    Don Imus was between "television gigs" while dad was struggling.  Before dad was diagnosed, he was disappointed and missed seeing the I-Man on MSNBC.  


    Although a fan of FNC, dad never understood Brian Kilmead's humor and he was frustrated because the banter was so quick and the Fox and Friends hosts often spoke over one another. 


    My dad would have appreciated Don Imus' approach to health struggles and cancer.  The medical community at Duke University destroyed my dad's courage to face his health condition.  Don Imus demonstrates a strength of character each day that would have been an inspiration for my dad.


    My dad grew up and even engaged in scientific medicinal research when cancer was known as the "Big C."  Dad appreciated the simple wisdom of Fox New Channel's Dr. Isadore Rosenfeld and never missed a Sunday morning with, as dad called him."the good doctor.


    I suspect there are many cancer patients that are men, dads, brothers (maybe even sons) in their 60s and older.  They are scared and, like my dad,  think of cancer as the "Big C" and a death sentence.  These men may be on chemotherapy or radiation therapy.  The men may feel weak and scared. They may even lose their courage and sense of humor.   My dad used the word "pathetic."  


    I encourage men (and women) to check out Don Imus on FBN for both the inspiration of Don Imus and the great business news.  Don's wife Deirdre Imus encourages healthy eating to build the body up.  The I-Man is a walking testament to the importance of positive attitude, nutrition and loving caregivers.


    In addition, Don and Deirdre Imus founded the "Imus Ranch for Kids with Cancer."    There are great opportunities to donate and purchase food items from Imus Ranch.  Please do something good for children and their families who are burdened with this horrific disease.  No child should have cancer.  http://www.imus.com/imus-ranch/

    Don Imus would have given my dad the courage to face cancer.  I feel certain that the I-Man does exactly that for men like my dad.



    Thursday, January 27, 2011

    Can Cancer Patients Ever Trust Duke Medical (Anil Potti, MD; chemo with osteomyelitis; etc)?

    Can cancer patients ever truly trust the once awe inspiring Duke University Medical?  


    Actually can any patient?


    I ask these questions with seriousness, respect and sadness.


    My dad (Robert W. Handy, PhD) was a medicinal scientist at the Research Triangle Institute (RTP, NC) during its infancy when Dr. Monroe Wall set a standard for ethics in scientific research.  


    At one point in his career, my dad was assigned (in addition to his research) the duty of evaluating potential internal RTI scientific ethics violations.  Dad never pushed those allegations under the rug; nor did my dad ever make excuses for wayward colleagues.


    My dad considered the scientific field of research to be sacred.  RTI has always had a stellar reputation.  When my dad was with RTI, the Institute had (and continues to maintain) contracts with federal government agencies.  


    During my dad's tenure, RTI performed research on cancer, lead poisoning, real life and death issues.


    My dad respected the integrity of Duke University Medical.  Despite the fact that he was virtually ignored by his Duke oncologists and left to die scared and in pain by Duke Infectious Disease and Orthopaedics, my dad respected the integrity of the research work performed at Duke.  I did my best to deal with the Duke physicians and keep dad from the very ugly truth that Duke University Medical did not care about him as a patient.


    I never told dad that Duke Medical dropped dad from all federally funded cancer studies after oncologists ignored dad and he contracted pneumonia.  I did, however, ask Duke why dad was dropped from the studies and how that fact was being explained in the research results.  


    I was told by the Duke cancer researchers that there is no record of dad being in any studies.  Odd.  I have the signed documents regarding the federally funded studies.  Dad was so proud to be apart of the research studies.  Dad had recently retired and he was actually honored to help Duke cancer research while he struggled with his illness.  Dad considered it his duty as a fellow research scientist.


    I would hate to see my dad's disappointed blue eyes right now.  The once awe inspiring Duke University Medical has changed.  Perhaps forever.  What we as patients thought was solid 24 karat gold has revealed itself to be a cheap gold colored veneer. 


    So, back to my question - how can patients ever trust Duke Medical?  Duke Medical lies, deceives and mocks patients who have life threatening conditions.


    1.  Duke University ignores all cancer patients (such as myself) with respect to Dr. Anil Potti specific work on breast, cancer, lung and any other cancers.  None of use know whether our health is affected.   


    The only way to find out if you as a cancer patient at Duke Medical were affected by the tremendous fraud of Dr. Anil Potti and Duke University is to hire an attorney.


    2.  Duke University ignores patients' pain when reasonable clinicians understand that pain is a valid and important symptom.  Duke University refused to remove the hardware from my December 2004 osteomyelitis (hydraulic elevator oil cleaned surgical equipment for Duke during that time frame) and that hardware remained in my body during the period 2006-2007 when Duke provided me chemotherapy and radiation therapy for cancer.  


    The hardware was ultimately removed in July 2010 and I have osteomyelitis from the osteotomy surgery.  That means that I probably had osteomyelitis during the period of time that Duke Medical treated me with chemotherapy and radiation therapy.  The painful hardware should have come out when the tibia healed.  


    There is concern about the effects of chemotherapy on the immune compromised body of a patent with active osteomyelitis.  Duke knew about two things: the likelihood that I had a bone infection and that chemotherapy could effect the bone infection (or vice versa).


    As my oncologist Dr. Gretchen Kimmick told me on the last day of chemotherapy "Lets just forego the final chemo treatment and ablate your ovaries.  We don't even know if the chemotherapy works.  If you were in Europe, you would not have even received the chemotherapy."


    3.  By all evidence, Duke Medical is continuing to use the surgical equipment that was contaminated in late 2004 by hydraulic elevator oil.  The screws and plates might be someone's body.  But, clamps and other reusable equipment is simply washed again.  However, according to independent studies at RTI, despite Duke's re-washing of the equipment, contaminates remained.  


    The surgical equipment is being used on all patients: cancer, heart, transplant.  It is inconceivable that Duke University Medical as an institution can allow this unethical conduct to happen every day.  


    It is nauseating that a human being that purports to dedicate his life to healing those who suffer (eg. pick any Duke physician) would allow contaminated surgical equipment to be used at Duke.


    Duke University and Duke University Hospital has not protected its patients with respect to any of these issues.  Duke just remains silent.  We are trained as Duke patients to be "good." "compliant," "non-resistant."


    Who precisely is protecting the patients?

    Tuesday, January 25, 2011

    The Sad Day When Orthopedic Surgeons Drank the Attorney Kool-Aid

    I was horrified when I learned that the AAOS (American Board of Orthopedic Surgeons) would actually discipline courageous orthopedic surgeons who would testify for injured plaintiff patients.  


    I would never ask an orthopedic surgeon to help me sue another orthopedic surgeon in a court of law.  I would seek compensation in another way.


    Recently, the AAOS offered advice for the orthopedic surgeon who becomes a defendant.  Darn those injured orthopedic patients.


    Feel free to read the AAOS' advise to defendant orthopedic surgeons.  It will make the average orthopedic patient feel about as welcomed in an orthopedic clinic as a chicken-hawk in a hen house.  


    The AAOS purports (like state medical boards) to maintain the integrity of the medical profession and protect the public.  But if the AAOS is punishing the injured plaintiffs' expert witnesses and ignoring incompetent orthopedic surgeons, how precisely is the AAOS serving any function to the public.  


    In fact, the AAOS does not protect orthopedic patients.  Quite the contrary.  The AAOS' actions harm and endanger the lives of orthopedic patients.


    Perhaps the only actual AAOS function is to protect bad orthopedic surgeons.  If so, then sadly, good orthopedic surgeons are paying their dues and attending events to finance the continuing bad orthopedic practices of their colleagues. 


    Speaking as an attorney, the most disturbing passage in the AAOS article is:
    In the U.S. legal system, the work of lawyers is not to find the truth, but rather, to provide the best advocacy for their clients under the circumstances. The trial of facts and the determination of the truth is a jury function, if the case ever gets to trial. How effectively a jury can find the truth is a function of advocacy and trial skills; a good defendant surgeon can help optimize these variables and influence the outcome of the case.
    Any attorney who takes a medical malpractice case (or any case involving liability) is ethically bound to evaluate the case and determine whether there is a legal basis to bring the case against a defendant.  It is absolutely irresponsible for the authors of this article to suggest that plaintiff attorneys for injured patients are uninterested in veracity.


    The authors of the AAOS article (below) are attorneys and are advising orthopedic surgeons.   In my humble opinion, it is reprehensible that attorneys instruct orthopedic surgeons to do anything less than be completely honest in the legal process.  


    There is no need to play games or be "coached" to manipulate a jury.  I cannot believe the attorneys would advise this.  I particularly cannot believe attorneys would publish the advise.  


    Attorneys should advise defendant orthopedic surgeons that "Sorry Works" and accountability works.  


    Attorneys associated with the AAOS should be concerned with protecting the integrity of the orthopedic medical profession and the safety of all orthopedic patients.  


    There is absolutely nothing in this article that addresses the very real possibility that the defendant orthopedic surgeon may have injured the patient.  Moreover, the orthopedic surgeon may be incompetent or have a personal (drug, medical, mental) problem that interferes with the surgeons ability to practice medicine.


    By its actions, the AAOS has shown itself to be dedicated to the protection of dues paying orthopedic surgeons at the expense of patient safety.



    The surgeon’s role in assisting defense counsel
    By B. Sonny Bal, MD, JD, MBA, and Randy R. Cowherd, JD
    Odds are that you, an orthopaedic surgeon, will be served with a medical liability lawsuit at some time in your career. The legal proceedings begin when the patient files a complaint with the local court, making you the ‘defendant’ and an unwilling participant in an unfamiliar and possibly intimidating process. Shortly thereafter, your medical liability insurance carrier will identify a lawyer as your defense counsel. This article presents tips and pointers for working closely with your attorney to reach a satisfactory outcome.
    Some rules are worth remembering at the outset. First, do not contact the patient or the lawyer representing the patient. The patient is now an adversarial party; any contact with opposing parties should be through your defense counsel only. Second, do not alter anything in the records that pertains to the care of the patient. Third, avoid leveling your frustrations at your defense counsel; he or she is charged with understanding the case and developing a theory of defense. This critical task will affect the outcome of the lawsuit.
    Working with you 
    
Do not wonder whether your assigned defense counsel will be more interested in protecting you or your insurance company. The lawyer, even though paid by an insurance company, owes a duty of professional responsibility to you, the defendant surgeon. The situation is comparable to the doctor-patient relationship; surgeons work in the best interest of their patients, even though the surgeons are usually paid by an insurance company.
    In some situations you may want to hire an independent counsel to represent you in addition to your assigned defense lawyer. An independent counsel can provide another source of legal advice and peace of mind and address concerns about asset protection, extent of liability exposure, business or practice interests, and other issues related to the lawsuit.
    An independent counsel may also be helpful if a conflict arises with the insurance carrier about matters of coverage or settlement negotiations. Some conflicts may preclude your assigned defense counsel from offering advice either to you or your insurance carrier. These concerns can be addressed by private counsel. To help develop a theory of defense and navigate through the procedures and technicalities of a medical malpractice lawsuit, however, the attorney appointed by the insurance company will suffice.
    Initial meetings
 
    The early meetings with your defense counsel will probably focus on your educating the lawyer on the medical issues involved and doing some legal housekeeping functions, such as completing interrogatories, submitting documents, and answering a list of questions posed by the plaintiff’s lawyer. These are formal steps in the adjudicatory process and should be taken seriously.
    Although paperwork is generally unappealing, successful defense of a medical malpractice claim demands the time, deliberation, and active engagement of the defendant surgeon.
    The information you provide will help defense counsel understand the case and formulate questions. The exchange of information, which may seem laborious and unimportant, actually plays a significant role in the case because matters exchanged between adversarial parties can be used as evidence at trial, either for or against you.
    The U.S. civil justice system is designed to encourage out-of-court dispute resolution. Through the discovery process—the gathering and exchange of factual information through interrogatories, depositions, and other mechanisms—it is hoped that the feuding parties can reach a meeting of the minds and resolve the dispute without a trial. Therefore, your answers to questions from both your counsel and the plaintiff’s attorney must be honest, complete, and forthright.
    During your initial encounters with your defense counsel, you should get a feel for personalities and professional styles. You can explain your side of the story and brainstorm without reservation; information shared with counsel is confidential and not discoverable by the opposing side.
    Focus on the complaint—the list of allegations contained in the actual lawsuit. Each allegation or complaint must be formally answered by the defense counsel; failure to do so on a timely basis can result in a default judgment for the plaintiff. The individual complaints must be answered with specificity and particularity; the defense counsel will help distill your side of the story to factual answers that are filed with the court.
    Developing a defense

    Once defense counsel has filed a formal answer to the complaint (in practice, this usually means denying all allegations), the adversarial system of dispute resolution requires that each party use discovery, depositions, literature review, and expert testimony for the following related goals:
           to learn and understand the strengths and weaknesses of the other side
           to develop a theory to support one’s own viewpoint and negate the other side’s arguments
    As a defendant, you should think about the most plausible theories to refute or negate the alleged complaints. Investigate the literature and identify expert witnesses who will agree to review the record and testify in court. Don’t defer these tasks to defense counsel; although experienced lawyers can identify credible experts in the field, there is no substitute for an active and engaged defendant.
    During the legal proceedings, some procedural steps may seem confusing and unsettling. For example, you may receive copies of letters updating the insurance company on the lawsuit. Insurance representatives may sit in during depositions and related activities. Defense counsel for any additional parties to the suit—such as a hospital, pharmacy, nursing home, or implant manufacturer—may attend depositions and raise objections for the record. The plaintiff patient may be present at your deposition, possibly with a family member.
    Your counsel may send a letter indicating a willingness to settle the case; some jurisdictions require this procedural maneuver so you can preserve certain legal rights. Specifically, such a letter may bar the insurance company from suing you after trial to recover monetary damages in excess of the settlement offer. A settlement letter does not mean that your counsel has given up on the case; ask about any procedural steps that may concern or be unfamiliar to you.
    Deposition tips

    Be sure to discuss your deposition by opposing counsel with your attorney. Not all information is admissible at trial, no matter how much the plaintiff’s attorney asks. Plaintiff’s counsel may inquire about prior lawsuits, but that history cannot be brought up at trial, unless some narrow legal exception exists. For example, if the present lawsuit alleges missed compartment syndrome after anterior cruciate ligament reconstruction, and the last six lawsuits against the defendant-orthopaedist alleged the same complaint under nearly identical sets of facts, procedural rules might allow admissibility of this history at trial.
    The goal is to focus on present facts and make the proceedings about the trial at hand only. But, as with anything else, exceptions exist; talk to your defense counsel to see whether an exception applies.
    You should know what factual information your defense counsel has had excluded from trial by court motion or other pretrial mechanism. For example, if your hospital instituted disciplinary hearings against you, your defense counsel could argue that these proceedings could bias a jury and successfully move the court to exclude this information from trial, or the information itself may be privileged from discovery. If you volunteer that previous peer-review hearings were decided in your favor, you may inadvertently enable the plaintiff’s attorney to introduce unfavorable details of those matters to the jury.
    Think twice

    Remember that for every good argument there exists an equally credible counterargument. Think through the allegations from the plaintiff’s side; go through the mental gymnastics of argument versus counterargument, and use your medical knowledge to help your counsel present the strongest defense possible. This will also help you maintain a professional demeanor during an otherwise difficult and emotionally taxing process. Juries want to believe the physician, and the burden of proof is entirely upon the plaintiff.
    In the U.S. legal system, the work of lawyers is not to find the truth, but rather, to provide the best advocacy for their clients under the circumstances. The trial of facts and the determination of the truth is a jury function, if the case ever gets to trial. How effectively a jury can find the truth is a function of advocacy and trial skills; a good defendant surgeon can help optimize these variables and influence the outcome of the case.
    Trial preparation is arduous both for you and your counsel. You should read the testimony of all of the experts and doctors involved in the case and fully understand the nature of the theories of liability being alleged. By working as a team, you and your counsel can bring forth the arguments against those theories at trial.
    Dr. Bal is associate professor of orthopaedic surgery at the University of Missouri in Columbia, Mo. He can be reached at balb@health.missouri.edu
    Randy R. Cowherd practices civil litigation and appellate work with the law firm of Haden, Cowherd, & Bullock, LLC, in Springfield, Mo. He can be reached at rcowherd@hcblawfirm.com
    AAOS Now
 November 2010 Issue



    Having surgery to remove hardware? Your body, Your car -- Get the parts

    Are you preparing to have surgery for removal of a stent or screws, nails, external fixator?  Think of yourself as a car.  Remember what your dad told you --- ask the mechanic to give you back the parts.  

    This is especially true in the era of Duke University and the hydraulic oil issue (Duke Medical reusing some surgical equipment such as clamps and scalpel from the initial 12/2004 mis-cleaning fiasco) and hospital born infections, you as the patient would be wise to keep the screws, nails, stents that are removed from your body.

    This is a discussion you have with the surgeon who is removing metal from your body before the surgery.  I recommend that the agreement that screws be saved for you be written on the Authorization for Surgery.  That document will have both your signature and the surgeon's signature.

    Am I suggesting that you request the hardware in anticipation of a medical malpractice lawsuit?  Absolutely not.

    Infections are serious.  I have osteomyelitis (a bone infection) that often occurs when foreign objects are placed into body/bone to fixate a bone.  

    In order to get well and healthy, the hardware helps infectious disease clinicians analyze the screws or other metal that were in the human body.  Anything that can help diagnose the infection and make the patient better is a tremendous resource for treating physicians.

    After the surgery to remove hardware, you may not have an infection.  Terrific. The screws are nice and could either:
    (1) hold up a heavy bookcase or 
    (2) serve as a lovely souvenir

    What would I do if the surgeon refused to save the hardware for me?

    (1) Politely ask for an explanation.
    (2) If the surgeon maintained his refusal, I would get another surgeon.  The screws belong to you.  They are in your body.  You paid for the hardware.  Why shouldn't you have the hardware.

    I want to pre-empt any possible extension of my argument.  I would never ask any surgeon to save diseased tissue or even a gall stone for me.  I stop at taking home inanimate objects that were placed in me by a human being.

    Sunday, January 23, 2011

    Thank You Cleveland Clinic Orthopedic Surgeon Dr. George Muschler

    For reasons that are known only to the physicians involved in the "Duke scam," Duke University Administrators sent me a copy of a letter written by Duke Medical cardiologist Michael Blazing, MD and sent to an Ohio orthopedic surgeon whom I still respect and admire.
    The surgeon who received Dr. Michael Blazing's letter was Dr. George Muschler and he is a very well-respected orthopedic surgeon at the Cleveland Clinic Foundation.  I had the privilege of meeting Dr. Muschler in October 2010 after the failed osteomyelitis surgery at Duke Medical.    
    However, the evening after I met Dr. Muschler did not go as expected.  As I planned to nest down in a hotel in my old law school haunt of Cleveland, Ohio and enjoy some great memories . . . I got sick.  Very sick.  Long story short, my getting sick and disoriented from my bone infection understandably made people comfortable in the orthopedics department at Cleveland Clinic.
    Cleveland Clinic personnel advised me that I made Dr. Muschler "uncomfortable" and so I tried to find another surgeon.  I did not want to be a bother such a fine surgeon.   
    I was not successful in finding another surgeon.  But Dr. Muschler decided to take the advice of Duke physicians (presumably Dr. Michael Blazing and Dr. Michael Bolognesi).  Sadly, those two Duke physicians did not/do not know me.
    I do not blame Dr. Muschler or any one else associated with Cleveland Clinic Foundation one single bit for that decision.  
    I thought about publishing a copy of Dr. Blazing's letter in this blog.  But this is not the proper venue.


    But I am saddened and disappointed that my character was defamed and the years I spent caring 24/7 for my precious dad were mocked in Dr. Michael Blazing's letter.  


    Patient advocacy is a serious business.  Patients should not be frightened into the thought that the doctors they trust will betray that trust by defaming and mocking them to other doctors.  


    I hardly knew Dr. Michael Blazing.  We met maybe 2-3 times during a two-month period last year (2010).  After Dr. Blazing sent the insulting letter about me to Dr. Muschler, Dr. Blazing sent me a couple emails that assured me: "CC is on board" and "Trust me."  


    I will always remember a telephone call with my favorite orthopedic surgeon (who practices in Chicago) as I was preparing to leave Duke University Hospital in September 2010. This Chicago orthopedic surgeon gave me the best medical advice any physician could give a patient: 
    "Cheryl, the only thing that matters is that you get well.  Let's just do whatever we have to do to get you well."
    Thank you for taking the time to meet with me, Dr. George Muschler.  It was a pleasure to meet you. I was impressed that you promptly singled in directly to my medical problem and put together a great medical treatment team (infectious disease specialist and plastic surgeon) and plan.  You are a fine clinician, Dr. George Muschler.

    Duke Medical's Ethical Scandal & Will Duke be Honest with Cancer Patients?

    A report obtained by Nature under the US Freedom of Information Act (FOIA) sheds light on the handling of a case of alleged misconduct at Duke University. 

    Duke continues to investigate the work of Anil Potti, a cancer genetics researcher whose publications formed the basis for three clinical trials that were closed in July 2010, after an investigative report in Cancer Letter revealed that Potti had inflated his resume, including falsely claiming to be a Rhodes scholar.
    Potti claimed to have developed “predictors” – computer algorithms that convert gene expression data from patients’ cancer cells into yes/no answers for whether the cancer will be sensitive to particular drugs. The clinical trials involved more than 300 patients with lung or breast cancer, who were given one of several existing several front-line therapies depending on the results of the predictors run on data from their cancer cells. 
    Potti resigned from Duke in November 2010, and took responsibility for errors in his published data. A major issue in the university’s handling of the case has been the fact that concerns over the trials were raised publicly more than a year before they were terminated, when biostatisticians Keith Baggerly and Kevin Coombes of the University of Texas' MD Anderson Cancer Center in Houston challenged the replicability of the predictors and questioned their experimental use in patients. In response, Duke briefly suspended the trials, only to restart them after a review panel charged by the university’s Institutional Review Board looked into the issue.
    The newly-released report sheds light on that panel’s thinking. It shows that the panel members found they were able to validate Potti’s work, using original data he provided. But the report also reveals that the panel did not verify that the data provided matched original raw data. Baggerly says it did not: “they had numbers with labels that the Duke group said applied, but the labels were wrong,” he says. Baggerly is particularly concerned by this because on November 9, 2009, when the panel was still deliberating, he obtained data that Potti had placed online, noticed it contained errors relative to data available in public databases that it was supposed to be sourced from, and sent a document to Duke's Vice-President for Research, Sally Kornbluth, and Duke's Vice-President for Medical Affairs, Michael Cuffe, pointing that out. He alleges that information was never forwarded to the panel by the Duke administration. "We think the outside experts would have had a better chance of detecting the error if they'd been told that we'd already found it," he says.
    Kornbluth responds that the review was conducted under the auspices of the Duke Institituional Review Board, which did receive a copy of the document from her. But, she explains in a statement sent together with Cuffe, the board, in consultation with Duke's leadership, decided not to forward it to the reviewers, "it was determined that it would be best to let the data, publications, etc., speak for themselves and not bias the independent investigation for or against any party. In retrospect, we did not realize that the data provided by our investigators were flawed (as the public record now shows), rendering an outside review addressing the methodology flawed as well. In hindsight, we would have ensured that the IRB provided all communication with Dr. Baggerly, recognizing the risk of bias. We've learned considerably from this process and are introducing key changes in the way we deal with research that will be translated to the clinical arena as a result," they say.
    In November Potti's co-author Joseph Nevins admitted that the data appeared to suffer from labeling problems and retracted a paper published in the Journal of Clinical Oncology. 
    A redacted copy of the Duke-commissioned report was previously obtained under the FOIA by Cancer Letter. The redactions left some parts of the panel’s thinking ambiguous. One redacted section dealt with the review panel’s use of a reference set, a dataset intended to help establish baseline levels of expression for the genes that were the subject of the predictor. Potti and co-authors did not previously use a reference set for their published work, and the report skates over the question of how they obtained good results without it, says Baggerly.
    Duke's second investigation into the matter is ongoing, and expected to report to the Office of Research Integrity at the Department of Health and Human Services, which funded some of Potti’s work through NIH grants.
    Image: West Campus / Duke Photography
    Posted by Eugenie Samuel Reich on January 05, 2011 


    http://goo.gl/onASj

    Saturday, January 22, 2011

    Is it Duke University Hospital Administrators or Physicians That are Dishonest?

    All physicians need to accept the reality that "Sorry Works" http://www.sorryworks.net/default  That includes Duke University Medical and every other major and regional medical facility.  Stop asking research facilities to hide facts (eg. Duke Medical requesting that RTI International misrepresent their research http://goo.gl/tjrwa)


    Given the good work by Duke.Fact.Checker, with respect to Duke University Medical, how can any surgical patient post December 2004 at any Duke affiliated facility (including Duke University Hospital) be certain that they have not been subjected to heavy metal contamination?  RTI International was asked by Duke to test surgical instruments cleaned by Duke.  The results were not comforting.





    CONCLUSIONS (According to RTI International)
    Surgical instruments that were exposed to hydraulic fluid as part of the cleaning process were found to have average levels of hydraulic oil residue of 0.08 mg per instrument.
    Brand new surgical instruments were found to contain an unknown residue at an average level of 1.26 mg per instrument. This residue was similar in chromatographic profile to the hydraulic fluid (i.e., lacking fine structure), but with a higher boiling point than the hydraulic fluid.
    Bulk hydraulic fluid was analyzed for the presence of potentially toxic metal contaminants and was found to contain only zinc at a level above 2 parts per million (ppm). Zinc was present at approximately 325 ppm.

    Personally, I had an osteotomy in December 2004, additional orthopedic surgery in May 2005, cancer surgeries.  And then I trusted Duke to care for my precious father through multiple cancer, prostate and orthopedic surgeries until his death in January 2010.

    It is not about a lawsuit.  It is about accountability and physicians being honest with patients.  We are not lab mice.  We are not a mere commodity or a means to an end for the medical facilities.  We are the patients and we are the most important people in the medical equation.

    So, let's find out what Duke.Fact.Checker can share.
    As Potti begins to tweet, lawyers circle Duke, sensing big bucks for malpractice
    Search terms "Anil Potti Duke University"
    There are two Fact Checker posts on Potti today; make sure you scroll down for the earlier.
    ✔ FC here.
    As Dr Anil Potti starts to emerge from the seclusion of his Chapel Hill home... building his Facebook site, sending out tweets (http://friendfeed.com/anilpottimd).....
    and apparently being behind the misleading regurgitation of a seven year old press release announcing a humanitarian award... 
    a Raleigh law firm that has taken on Duke University in the past says it is doing "research" on the Potti Mess. 
    The firm Henson Fuerst put out a PR release seeking information from Potti patients, which seems to FC like a thinly disguised effort to sign them up for lawsuits. Other Raleigh injury lawyers -- the Temple firm, and Brent and Adams -- have frequently used this tactic too, so expect them on the bandwagon. 
    Henson Fuerst represented plaintiffs in the Duke hydraulic fluid case in 2004, where two community hospitals run by Duke supposedly fully up to its standards (but not the principal hospital on West Campus) washed surgical instruments in dirty, used hydraulic fluid from an elevator instead of antiseptic detergent. 
    For months, surgeons complained of greasy and slippery instruments. In other words, Duke did not move to investigate and correct immediately -- and plaintiffs' lawyers loved it.
    In many cases, instruments used in surgery are disposed after one use. But not so with clamps (to cut off the flow of blood), holders for the blades of scalpels, and other things.
    Interestingly, in that case, Duke's point guard was Dr. Michael Cuffe, who then had the title vice president for medical affairs of Duke Health.org (he has since added Vice Dean of the Medical School). Very highly regarded in Duke's hierarchy, photogenic and well spoken, Cuffe came to Duke to earn his MD '91, stayed for all his additional medical training and burnished his credentials with an MBA '09. He has taken on a similar role in the Potti Mess, repeatedly making statements and giving interviews. 
    In the hydraulic case, Duke created an extensive website with information for patients; not so in the Potti Mess where patients and reporters alike have to dig for every scrap. 
    3500 people had surgery with the elevator fluid. 3500! It's never been clear how many patients were infected because their surgeries occurred with instruments not properly sterilized. And infected with what? Bacteria? Or even blood born diseases.
    Nor do we know how residual chemicals that may have gotten directly into surgical wounds affected people.
    We don't know either the total cost of malpractice claims that Duke paid -- this university doing everything under cover of darkness. People who settled with Duke were required to shut up, to sign a confidentially agreement. That's the course that Duke finally took with the Henson Fuerst clients. 
    The total was very substantial. Very. 
    Fellow Dukies, you haven't seen anything yet. The Potti Mess is a plaintiff's lawyers dream:
    -- A defendant with lots of money and institutional arrogance. 
    -- Plaintiffs who will have great emotional impact on a jury.
    -- Plaintiffs who signed contracts for clinical trials -- informed consent forms -- that were violated, so the basis for the lawsuits is not the slippery slope of malpractice alone.
    -- Plaintiffs who suffered from malpractice. This is always tough to prove, and requires far more than just an unexpected or bad outcome from treatment. But if anyone is up to the challenge, Potti is!!
    -- And most importantly to add on the bucks in any settlement, deliberate acts by Duke administrators -- like concealing the Baggerly e-mail that would have blown Potti out of the water far earlier. 
    FC
    These people got a rough ride when they came to Duke as patients. Wait until you see what happens to them when they return as plaintiffs, for Duke has a reputation of dragging out litigation and being very scrappy.
    Fellow Dukies, this is bad.

    Friday, January 21, 2011

    Care-giving After Your Loved One Dies

    Care-giving and advocating do not end when the loved dies.  The care-giving needs to be for yourself and the advocating needs to be for both yourself and the deceased.


    It has not been so long ago since my dad died. It was just last year and only months before I became sick.   There are still issues mom and I need to resolve in dad's estate.


    But, in the meantime, my mom's best friend lost her husband from diabetes.  It was a horrible death.  He was a terrible patient.  Doctors actually dumped him months before his death because he was old and grumpy.  I would have been too.  He had multiple system failure (heart, lungs, kidney).  


    I recall trying desperately (in October 2010) to find Rana a physician who would help him. A kind physician agreed to treat Rana. But Rana left us and joined God during a dialysis treatment.


    Rana was from India.  He was a permanent resident but chose against applying for U.S. Citizenship.  When I practiced immigration law, I offered to help him pro bono but he declined my offer.  His wife Pramilla accepted my offer and is a U.S. Citizen.  


    Now I am helping Pramilla (a widowed naturalized U.S. Citizen with no dependents) deal with the aftermath of a death post years of 24/7 care-giving.  My initial help to Pramilla is instructive generally.



    Autopsy? Best to think about at the time of death
    If your loved one is under the care of a physician at a major teaching hospital then it is likely that a complete autopsy can be done at no expense to the family.

    My dad was being treated at Duke University Medical Center at the time of his death.  Duke did not offer the autopsy.  But I made the request to Duke and I am glad I did.  The autopsy answered many questions for our family.  Dad was cremated.

    If the deceased was a recent patient and the family is interested in an autopsy, ask the funeral home whether the medical facility will perform an autopsy.  The funeral home will know (or find out) that information.  The funeral home needs to know if you are interested in an autopsy before they embalm.   

    Remember, you don't have to read the autopsy results today, this year or next year or ever.  But you have the results and that is very respectful for the deceased.



    Shock
    The first and most thing to remember is that the shock Pramilla will feel is different than the shock of a sudden, unexpected death of a loved one.  Pramilla grieved the stages of death throughout the care-giving process.  But Rana was alive and there was always hope.  And there was always Rana.


    Pramilla's shock is combined with battle fatigue and a type post traumatic stress syndrome.


    Battle Fatigue
    After years of care-giving, Pramilla is completely worn out.  The feelings are very similar to battle fatigue.  


    With respect to my caring for dad, I specifically recall learning to sleep lightly. I would be on "high alert"  for any noise my dad would make and I would jump into action.  I expect Pramilla did the same for Rana.  It takes many months to be able to sleep through the night.  For me, the answer was a good psychiatrist. I already had the relationship during my bout with cancer and continued the relationship throughout dad's illness.


    Sleep and Meal Routine
    Pramilla needs to get herself on a routine as if she were a child.  She cannot wait to eat (a healthy meal) when she is hungry or sleep (in bed) when she is sleepy.  Her body is out of sync.  There is comfort and health in routine. 


    When she cared for a very sick husband, Pramilla slept and ate when she could. Cat naps were the routine.  I doubt Pramilla enjoyed a quiet meal.  


    Get out of the house  
    My mom owns her own business and encourages Pramilla (admittedly her employee but also her friend) to drop by the business anytime just to visit.  


    Pramilla needs to get out of the house.  It does not matter whether Pramilla is taking a walk, grocery shopping, visiting with friends, going to church.  The important thing is for her to brush their teeth, wash her face, get on shoes and see people.  It is all about the "life is for the living" thing.


    It is okay to cry
    Crying is more than okay.  Crying is good.  


    Death Certificate and Letters to Creditors
    We tried to make telephone calls to all of the utility companies, investment companies.   
    1.  Investments were easy because dad put everything in "joint ownership with right of survivorship."  
    2.  Our small town utility company was easy. They told us to keep the account in dad's name to avoid the transfer fees.  
    3.  AT&T was a nightmare.  I wish dad had put that in both mom and dad's name.  For months, we received two bills, one in mom's name and one in dad's name!  Actually, I am still working on AT&T.
    4.  Department of Motor Vehicles was a breeze since dad had the cars titled in both names.  
    5.  Home, Auto, Health Insurance was a breeze since dad had the names in both.
    6.  Bank Accounts were in both names with right of survivorship.


    Pramilla's husband Rana did not have the foresight of my dad.  The accounts were not in both names. She will have a bit more trouble.  She will need a good certified copy of the death certificate to send or hand to each creditor.


    Pramilla and Rana also just purchased a home.  My parents no longer have an active mortgage.  But she will need to deal with the mortgage.


    Canadian Citizenship
    Rana was a Canadian citizen.  I will help Pramilla check with that Government to access whatever death benefits she is entitled to receive.


    United States Social Security Administration
    I will grab my walker and accompany Pramilla to the SSA because no one should have to deal with that agency themselves.  As is typical, Pramilla received the two seemingly contradictory (but absolutely confusing)  letters.  


    One SSA letter says she gets about $255 for death benefits.  But the first letter does not make it clear that it is a one time payment.  Then the second letter explains how the SSA is taking back money and the widow must wait about six weeks to get a penny.  Get a friend to go with you to the SSA and have them explain the benefits.  If you can understand the SSA letters, you are still in shock.


    Do not make any major life decisions for one year
    I am a strong believer that a survivor of a death post 24/7 care-giving should not make any major life decision until the completion of one year.  The person is not simply grieving the loss of a loved one.  The former caregiver needs to heal from the stress and wear/tear of 24/7 wear-giving.


    It does get better
    After a year, my memories of my dad have changed.  The primary memory is no longer the day he died. The day my dad died was just one day in a lifetime of memories. Now I remember and think about the great times with my dad.  I think dad would prefer that.  


    And someday Pramilla will be able to think about great memories of Rana before she thinks about the sadness.  I hope I can help my friend with that journey.