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Showing posts with label epp. Show all posts
Showing posts with label epp. Show all posts

Who to Trust? Reading Medical Articles with A Grain of Salt

How much faith should we put in published, peer reviewed studies which show that a drug, vitamin, surgical technique or medical device produces a favorable result?

We certainly want to believe that a conclusion based on raw data generated in a properly designed test by objective scientists must be true and is therefore reliable.

A recent article in The New Yorker -- "The Truth Wears Off “ -- by Jonah Lehrer reminds us of the perils of putting all our faith in scientists who, like the rest of us, are fallible. Scientists, especially medical researchers, he contends, tend to select their data to confirm a preconceived thesis, especially if they want to publish their study in a prestigious journal

Once a "truth" gets established – e.g, cardiac stents work, PSA tests save lives, Vitamin E is good for you, hormone replacement therapy for menopausal women works, second generation anti-depressants are effective, etc -- it's hard to un-establish it. Few journals put priority on publishing studies that show that a drug or device had "no effect," a phenomenon which Lehrer calls "publication bias."

The writer's point is not that our medical journals are rife with scientific fraud. In the real world, scientists struggle with making sense of their data. If there are anamolies that don't seem to follow a pattern, they might get tossed out. Like anyone else, a researcher is wired to want to disregard what he or she doesn't want to see, or can't explain.

Once Touted, Now Doubted

Vitamin E and D megadosing
Cardiac Stents
Hormone Replacement
Avastin for Breast Cancer
Baycol, Fen/Phen,Bextra
Thalidomide for morning sickness
Mastectomy
PSA test
Lobotomy
Extra Pleural Pneumonectomy



As Lehrer observes: "The problem of selective reporting is rooted in a fundamental cognitive flaw, which is that we like proving ourselves right and hate being wrong." Quite simply, it feels good to prove a hunch. It feels even better, he notes, when the researcher has a financial interest in the outcome, or stands to advance his career.

The answer, Lehrer argues, is in properly designing studies and making sure the data are both transparent and rigorously gathered, even if they contradict the hypothesis. Moreover, before publishing, the scientist should lay out on the front end what's a sufficient level of proof. He also suggests the use of accessible databases (something near and dear to Dr. Cameron and the Pacific Meso Center).

Bringing the subject closer to home, for many decades now US doctors have been quick to tout the extra-pleural pneumonectomy (EPP) as the best treatment for mesothelioma. Studies, mainly out of the Brigham and Women's hospital, have been published to prove the point. Several years ago, a big clinical trial, financed by Eli Lilly, showed that the chemotherapy drug Alimta was superior to doing nothing. Alimta went on to become the "front line standard of care" for pleural meso patients.

As you read up on the treatment options available, and listen to experts, it’s wise to stay on guard. Ask yourself, was the research based on selective reporting (aka, "cherry picking" the patients who did well but casting out those who didn’t)? Have the data been made available for review? Have the conclusions been validated elsewhere? Was the clinical trial randomized? Were apples compared to apples (if that’s even possible!).

Note that there has never been a clinical trial in the US in which pleural mesothelioma patients were randomly selected for either an EPP, a Pleurectomy/Decortication, or no treatment. Putting the ethical morass aside (I don’t think a patient would be eager to participate in a trial in which he was forced to do nothing or have his lung amputed), even if there was a well designed study, clearly surgical technique could not be 100% replicated, and every patient is different (genetics, age, sex, staging, pre-existing conditions, tumor cell type, will to live, etc).

In the end, we wind up making choices based on trust. Do we trust the doctor and his team? Do we trust the "science" on which he bases his opinions? Does he admit what he doesn't know? Does he follow the current fad or stubbornly cling to a one-size-fits-all strategy? Does he have passion without the in-your-face zeal ? Does he have a possible conflict of interest where, for example, he's got an irrepressible financial or career incentive to push one flavor over another?

Has your doctor tried to maintain “neutrality?” Radical surgery will transform the patient’s life irreparably. Has your doctor tried to suppress his own bias, anger or elation in recommending a treatment? Has your doctor truly explained whether an option first, does no, or at least very little, harm, balanced against the prospect of measurable benefit?

It’s not easy for a surgeon, or anyone, to “go Swedish” and consciously set aside biases. One thing is for certain, you’re not getting a fair shake if your doctor tells you he’s going to cure your mesothelioma. There is no proven cure for mesothelioma, period. At best, with an enlightened strategy, orchestrated by the an honest and caring medical team, meso patients can buy valuable time.

As WC Fields used to say: Trust your fellow man, but always cut the cards.

Roger G. Worthington, Esq.
December 15, 2010

“Your firm really cares about my well-being.”

In April of 2009, Kathy first noticed she was having difficulty taking deep breaths. She met with her family physician who performed several tests including a chest x-ray. The x-ray revealed a pleural effusion.

In June of 2009 she underwent a left-sided thoracentesis with pleural biopsy in Wenatchee, Washington. Immunohistochemical staining of the biopsied tissue resulted in a diagnosis of malignant mesothelioma. Upon learning of the diagnosis, she met with an oncologist in Wenatchee who recommended that she consult with Dr. Eric Vallieres in Seattle, Washington.

In July of 2009 Kathy met with Dr. Vallieres and his staff at the Swedish Medical Center where they discussed her eligibility for the extra-pleural pneumonectomy. Dr. Vallieres felt she should first undergo chemotherapy treatments using Alimta in conjunction with Cisplatin. A CT scan taken before the third round revealed a reduction in the size of the tumor.

As a result of this favorable response and after subsequent tests, Kathy underwent surgery on her left lung on October 5, 2009.

Kathy completed her 28 day cycle of radiation at the end of January.

In March Kathy returned to her job full-time. While she loves staying busy, she and her husband were ready to take a vacation after the challenging year they have had. They recently returned from a relaxing trip in Cabo San Lucas, Mexico and are feeling recharged for the season ahead. Meanwhile, Kathy has been faithfully keeping up with her physical therapy appointments several times a week to help regain strength and mobility on her left side.

Kathy last saw Dr. Vallieres in May and is seeing him again later this October. Her doctors have been monitoring a small spot on her spine that is most likely benign. However if the spot turns out to be more serious, she has already consulted with a radiologist on how to treat it. She recently learned about the relatively new CyberKnife treatment which is a non-invasive, non-surgical method of delivering radiotherapy to very targeted areas.

It’s hard to believe a year has gone by since Kathy’s EPP surgery! She continues to be very appreciative of the Worthington Law Firm. “I feel your firm really cares about my well-being and are experts about mesothelioma treatment.”

Dr. Cameron Proposes IMIG Consensus Statement on the Role of Surgery in Mesothelioma Treatment


Recently several hundred doctors and scientist from all over the world with an interesting in mesothelioma met in Boston to discuss, among other things, the role of surgery in treating meso patients (the "IMIG" group).

Earlier, a paper had been published out of the UK that questioned the merits of extrapleural pneumonectomy (EPP)  as compared to chemotherapy alone (the trial didn't offer pleurectomy/decortication).  The IMIG group pointed out various flaws in the design and operation of the trial.  In particular, the clinical trial, the first of its kind anywhere, had terrible trouble over a period of three years recruiting the 50 patients it needed for a pilot trial. The MARS group's plan was to follow up the pilot study with a full blown and statistical meaningful mega-trial of 670 patients. They never got there. 

Of the 50 meso patients they did recruit, many of those did not complete the arm of the study they started (ie. surgery only or chemo only), or they crossed over (from surgery to chemo, or vice versa) during the trial. 

The MARS authors to their credit did acknowledge this deal-breaker problem. They went so far as to question whether a clincial trial of this kind was ever feasible at all in the real world, where patients simply don't want to be "guniea pigs" even in the greater interests of medical advancement. A clinical trial of this scope has never even been attempted in the US.

In the US, patients have many choices, and it remains "muddy" what the best option is across the board for the "average" meso patient.  Dr. Cameron and Dr. Sugarbaker have publically disagreed over which surgery is "better" - ie. EPP vs Pleurectomy/Decortication. However, both agree today that the role of surgery is to remove as much tumor as you can see (what Dr. Sugarbaker has coined "complete macroscopic resection" (MCR)).  Dr. Cameron has been a long time advocate of pulling up his sleeves and pulling out a much tumor as he can see, without watching the clock, noting that "negative margins" was and always will be a pipedream for a meso surgeon.

I encourage you to read the draft proposal submitted by Dr. Cameron, which is based on an earlier draft proposed by Dr. Sugarbaker.  Although there are stylistic differences, both agree that surgery should be performed along with adjuvant care to attack the unseen tumor cells that remain in the body after surgery.

As Dr. Cameron tactfully writes: "The exact surgical procedure should be based on disease distribution, surgeon preference and experience, and institutional experience and should be performed with a morbidity and mortality consistent with published literature." 

As a patient, before making your decision (e.g., chemo only? What chemo? Surgery? What operation? By whom and where?),  the IMIG Group has also recommended that you follow these important guidelines:

  • Pathological diagnosis including histologic subtype should be established by tissue biopsy.
  • Clinical staging be performed prior to initiation of therapy and should include PET with lymph node sampling and/or MRI as indicated.
  • The type of surgery (EPP, P/D, etc) should be based on clinical factors as well as individual surgical judgment and expertise.
  • Complete surgical stating should include hilar and mediastinal lymph node removal.

To review a complete text of Dr. Cameron's proposed IMIG consensus statement, please click here.  The IMIG board will review all comments and submit the final approved version for publication in a suitable journal with collective authorship.  Doctors as well as patients need and deserve this kind of up-to-date education. We applaud Dr. Cameron and Dr. Sugarbaker, as well as all the other doctors, who have participated in this project.

RGW
10/16/12

Debunking the Myths About P/D

"The Question is, Why Wouldn't a Patient Choose P/D?"

In 1994, Dr. Robert B. Cameron began to develop his specific "radical" lung-sparing pleurectomy and decortication (P/D) surgical procedure as a more rational and less radical alternative to the popular radical extra-pleural pneumonectomy (EPP) surgical procedure for malignant pleural mesothelioma (MPM).

The data show that P/D is much safer than EPP. Surgical mortality (that is, when the patient dies during surgery) for P/D is only 3-4%. For EPP, surgical mortality is 5-7%, or almost twice as high. On top of fatalities, another two-thirds of EPP patients encounter serious surgical complications. Dr. Cameron’s surgical mortality numbers are below 1%.

P/D patients retain the use of both lungs, affording them a better quality of life. EPP patients are left with only one lung. With only on lung, the patient is vulnerable to threats to the remaining lung like infection, pneumonia or pulmonary restriction from prior smoking, asbestos scarring or the unshakeable threat of mesothelioma recurrence.

The only randomized trial for EPP (where the surgeon cannot bias the results through patient selection), revealed that patients who had EPP in fact did worsethan patients who avoided surgery altogether. Studies which have looked at both EPP and P/D reveal that P/D patients survive longer.

With P/D’s superiority overwhelmingly confirmed, the question is then, why wouldn't a patient choose a P/D over EPP? It seems that those clinging to the out-dated notion of performing EPP have tried to answer this question with a series of “myths” about P/D.

Over the coming weeks, Dr. Cameron, as the innovator of the P/D and the surgeon most experienced in performing it, will address in turn each of these "myths".

MYTH #1: “P/D Is Only Appropriate For Very Early Stage Meso.” January 3, 2011

Proponents of the EPP have been known to suggest that “P/D is fine for early-stage cases, but for a BIG tumor you need a BIG surgery.”

It is certainly true that lung-sparing P/D is more appropriate for early-stage cases than EPP. For a patient who is younger with less invasive tumor and a good long-term survival prognosis, there is simply no compelling reason to endure the risks and compromised quality of life associated with a radical lung amputation/EPP.

But just because P/D is more appropriate for early-stage patients does not mean that radical EPP is better for more advanced patients. Statistics reveal that P/D is also better advanced cases of pleural mesothelioma. In fact, many of those who argue that P/D is only appropriate for early-stage meso WILL NOT actually perform EPP for late-stage meso. They understand that EPP is too radical and difficult for late-stage patients and don’t want to harm their published survival statistics. They route their late-stage patients to P/D instead.

As a result, most studies comparing P/D to EPP show patients who were younger (less than 60) and relatively healthy going to EPP, and patients who were older (70 or above) and with more sickness going to P/D. Yet the overall survival for older, more advanced patients who had P/D was still BETTER than the survival for younger, less advanced patients who had EPP.

Click here for more information regarding malignant pleural mesothelioma and Dr. Cameron’s approach to treating the disease.

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