Cancer Expert Witness

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Cancer Answers Medicare Fraud in Oncology – The Farid Fata Case

Category: Medical Fraud

Breathtaking case from Michigan, the “Doctor” Farid Fata case.

Per CNN Dr. Fata, “pleaded guilty to 13 counts of Medicare fraud, one count of conspiracy to pay or receive kickbacks and two counts of money laundering….one of the worse cases of medical malpractice in US history”. CNN also reported that prosecutors said, “Some 553 patients received medically unnecessary infusions or injections”. On July 10, 2015 it was reported on Medscape that, “The excessive and unnecessary treatment, which went beyond chemotherapy, was part of a massive criminal scheme that netted $17 million from Medicare and private insurers, according to federal prosecutors. It encompassed Dr. Fata’s oncology practice and its seven locations in suburban Detroit, a pharmacy, a diagnostic testing center, and a radiation treatment center he owned; and a sham charity he founded”.

Dr. Fata was sentenced to 45 years in jail.

Comments: MORE QUESTIONS THAN ANSWERS

  • Have not read the court transcript, but plan to.
  • Response of American Society of Clinical Onocology (ASCO)?
  • Response of American Society of Hematology (ASH)?
  • Response of Memorial-Sloan Kettering?
  • Response of LARA? (state-run Department of Licensing And Regulatory Affairs); per investerhub.advn.com LARA reportedly cleared Fata of any wrongdoing in May 2011 after complaint filed in May 2010. I have not independently reviewed the complaint.
  • Response of other physicians in the practice?
  • Response of oncology nurses administering the drugs?
  • Is his wife being prosecuted?
  • Did all of the other health care professionals, who could have or should have known what was happening, get a legal free pass?
  • What is responsibility of his medical school, and the institutions he trained at?
  • As reported in the Detroit News, how is it that oncology nurse, Angela Swantek (who was only applying for a job there), came forward to report wrongdoing before anyone else?
  • IT IS MY OPINION BASED THAT IF THE INFORMATION AVAILABLE TO THE PUBLIC REGARDING ANGELA SWANTEK IS CORRECT, THAT SHE SHOULD RECEIVE A SPECIAL AWARD OF RECOGNITION FROM ASCO AND ASH.
  • ASCO, ASH, ASTRO SHOULD HAVE MANDATORY MEETINGS AND SET SOME STANDARDS FOR FINANCIAL AND MEDICAL ETHICS AT THEIR ANNUAL MEETINGS AND SHOUILD BE A MANDATORY PART OF MEDICAL SCHOOL AND POST-GRADUATE TRAINING.
  • IT IS A REALITY THAT MEDICAL MALPRACTICE AND FINANCIAL IRREGULARITIES ARE GROSSLY UNDER-REPORTED FOR A NUMBER OF REASONS INCLUDING LEGAL EXPOSURE FOR THE WHISTLEBLOWER. THE CONSEQUENCES FOR A FEDERAL WHISTLEBLOWER IN A CASE THAT HAS A NEGATIVE OUTCOME FOR THE PROSECUTION (OR FAILURE OF THE FEDERAL GOVERNMENT TO PROSECUTE) COULD BE THE EQUIVALENT OF FINANCIAL/PROFESSIONAL/LEGAL SUICIDE.
To discuss this, or any other topics found in Cancer Answers, or related to oncology or hematology, please contact Dr. Steven Mamus. 

 

 

 

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13 July 2015, 19:24
 

Cancer Answers Can Skin Cancer Be Prevented By Vitamin Therapy?

Category: Skin Cancer

Interesting report from Sydney, Australia at the ASCO 2015 meeting.

The phase III ONTRAC trial tested nicotinamide (form of vitamin B3) 500 mg twice per day versus placebo for one year in a high risk population. Definition of high risk population: individuals with history of at least 2 non-melanoma skin cancers within 5 years of randomization to study.

Interesting results with relative rate reduction of 23 percent for new skin cancer and 13 percent at 12 months of treatment. Benefit ceased when nicotinamide was discontinued.

Comment: simple, cost effective way to have important impact on decreasing the development of new skin cancers.

To learn more about this, and other cancer therapies, please contact Dr. Mamus, Florida's Cancer Specialist. 

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02 July 2015, 19:37
 

Cancer Answers If You Get Cancer, Will You Have a Medical Oncologist?

Category: Oncology Workforce

Summary of ASCO Report: “State of Cancer Care in America 2015”

1. This report summarizes the increasing pressures experienced by oncology practices, including unrelenting increase in pharmaceutical costs and the significant increase in administrative time and expense required to run a practice.

2. This same issue was discussed at some length at the recent ASCO 2015 meetings in Chicago, with detailed discussion regarding the expense and lack of efficiencies with interactions with the insurance industry in particular.

3. Importantly, this report from J. Oncol Pract 2015; 11(2)79-113 points to an expected 45% increase in cancer incidence experienced by 2030. This is of grave concern, since 20% of medical oncologists in the United States are at least 64 years of age.

4. Comments:

  • Remarkably, up to 30% of oncology fellows report professional burnout even before starting practice.
  • The general sense of many practitioners is that younger physicians appear to wish to work less hours than older oncologists, and perhaps to retire earlier.
  • Supply and demand mismatch is already being felt in rural and underserved areas.
  • "I think that we are going to be coming to a point where there simply will not be enough people who are formally trained and certified in oncology to take care of all of the patients"...from Dr. Edward Benz, the president of the Dana-Farber Cancer Institute, quoted in Clinical Oncology May 2015, Volume 10, No.5.

Please don't hesistate to contact Dr. Steven Mamus with any questions or concerns. 

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25 June 2015, 15:54
 

Cancer Answers Docetaxel and/or Zoledronic Acid for Hormone Naïve Prostate Cancer Abstract #5001 ASCO 2015

Category: Prostate Cancer

First results of STAMPEDE trial

Summary:

1. Docetaxel, added to standard hormonal therapy, improved overall survival by median of 10 months with hormone naive, newly diagnosed individuals with advanced prostate cancer. PI of the study Nicholas James MD, PhD of the University of Warwick and Queen Elizabeth Hospital, Birmingham, England

2. "Docetaxel improved survival in patients with newly diagnosed metastatic prostate cancer starting hormones, and it should be routinely used in these patients as part of upfront therapy. In non-metastatic disease, docetaxel should be offered to men about to start hormone therapy for the first time, because it prolongs failure-free survival. There is some uncertainty regarding its effect on overall survival in men with non-metastatic disease, and longer follow-up is needed. It’s clear that zaledronic acid does not benefit patients with advanced prostate cancer and should not be offered as upfront treatment" (ASCO POST, May 25, 2015 page 1)

3. STAMPEDE is the largest randomized trial conducted for treatment of prostate cancer

4. Comment: represents major change in standard of care for newly diagnosed prostate cancer patients presenting with advanced disease

Please don't hesitate to contact Dr. Steven Mamus to discuss this topic. 

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09 June 2015, 02:31
 

Cancer Answers Checkpoint Inhibitors for the Treatment of Advanced Colorectal Cancer

Category: Colorectal Cancer

One of the most interesting abstracts at the recent 2015 ASCO meeting was a presentation by Dr. Le from Johns Hopkins. This work, which was presented at ASCO and printed online in the NEJM "PD-1 Blockade in Tumors with Mismatch-Repair Deficiency," in my view was one of the most compelling papers of the meeting.

Pembrolizumab 10 mg/kg was administered every 2 weeks in patients with metastatic colon cancer with or without mismatch repair deficiency.

CONCLUSIONS and MY COMMENTS:

1) Whole genome sequencing demonstrated 1782 somatic mutations per tumor in mismatch repair deficient tumors compared to 73 mutations in mismatch repair proficient tumors

2) Checkpoint inhibition of PD-1 is more effective when more somatic mutations are present

3) Increased number of somatic mutations create a target rich environment for activated T cells

4) The creation of neoepitopes results in more favorable response with checkpoint inhibition

5) Objective response rates for colorectal cancer mismatch proficient tumors was 0%

6) Objective response rate for mismatch repair deficient colorectal tumors PFS of 40% and immune related PFS of 78%

7) This remarkable paper is noteworthy for targeting EXPENSIVE yet EFFECTIVE therapy to the right group of patients

8) This paper also extended, in preliminary fashion, the same molecular targeting concept to tumors other than colorectal cancer

For more information, please contact Dr. Steven Mamus. 

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03 June 2015, 14:53
 

Cancer Answers Pertuzumab, Traztuzumab, and Docetaxel in HER2-Positive Breast Cancer

Category: Breast Cancer

Summary of Article By Swain et al New England Journal Of Medicine 2015; 372:724-734

 

1. Comparison of placebo + traztuzumab + docetaxel versus pertuzumab + traztuzumab + docetaxel

2. Trial design – first line therapy, randomized, double-blind, placebo controlled phase 3 study

3. 808 patient underwent randomization

4. Median follow up 50 months

5. Results: “overall survival significantly improved...in HER2-positive metastatic breast cancer with the addition of pertuzumab to traztuzumab and docetaxel, as compared with the addition of placebo”.

6. Overall median survival for pertuzumab not reached at 50 months of follow up

7. Study allowed for cross over and analysis not adjusted for crossover

8. Benefit of pertuzumab likely understated due to (7)

Dr. Steven Mamus is a cancer specialist in Sarasota, Florida. Please contact us for more information. 

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21 May 2015, 08:09
 

Cancer Answers Afatinib Approved for Lung Cancer Treatment - FDA Approval July 12, 2013

Category: Lung Cancer

A new targeted therapy has been approved by the Food and Drug Administration for the treatment of lung cancer. This new agent is for the management of epidermal growth factor receptor positive non-small cell lung cancer with abnormalities in EGFR exons 19 or 21.

Afatinib is a new class of tyrosine kinase inhibitor for treatment of lung cancer. This agent is also being investigated in a number of other solid tumors including breast, head, and neck cancer.

Of interest, the pivotal LUX-Lung 3 trial demonstrated progression-free survival superiority versus  a combination of cisplatinum with pemetrexed in patients with EGFR positive tumors. Symptom control favored Afatinib.

Afatinib has been shown to be active in patients that have tumors resistant to Erlotinib and Gefitinib. At a molecular level Afatinib is an irreversible inhibitor of EGFR while the other two agents are reversible inhibitors of EGFR.

The side effect profile of Afatinib seems to be similar to Erlotinib and Gefitinib, pending availability of the FDA approved drug insert for the new agent.

Please don't hesitate to contact Dr. Mamus for more information. 

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25 July 2013, 12:07
 

Cancer Answers Tobacco Use in Patients Diagnosed With Cancer – American Association for Cancer Research (AACR) – “Policy Guidance on Tobacco and Cancer Clinical Trials”– Released April 9, 2013

Category: Tobacco Use

Summary of AACR Tobacco and Cancer sub-committee statement:

(1) The oncology community should provide evidence based tobacco cessation programs for patients with cancer and individuals being screened for cancer.

(2) The oncology community needs to carefully document smoking history in a comprehensive fashion for all patients on clinical trials. Tobacco use should be evaluated as an independent factor in clinical trial outcomes.

(3) Remarkably a survey of National Cancer Institute (NCI) designated cancer centers according to the AACR found that “only 38% of the responding centers recorded smoking status as a vital sign and less than 50 per cent have dedicated tobacco cessation personnel.”

(4) According to the AACR statement a recent evaluation of 155 NCI Cooperative Group trials found that a tobacco history of any type was taken in only 29% of cases.

(5) The AACR report effectively has strongly suggested a comprehensive tobacco history should be obtained at every office visit, smoking cessation programs should be instituted and the role of tobacco use in clinical trials needs to undergo far greater scrutiny.

Comment: This is a sobering report…we can do better.

Please contact Dr. Mamus with any questions or concerns. 

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18 July 2013, 09:17
 

Cancer Answers Early Lung Cancer – American Society of Clinical Oncology Meetings, Chicago2013, and Journal Updates

Category: Lung Cancer

Abstract 7571

“Outcomes of early stage lung cancer treatments in older patients: A SEER database analysis”

Conclusion: 

This multivariate logistic regression outcome analysis of over 10,000 patients diagnosed with stage I or II lung cancer, ages <65, 65-75, and greater than age 75  compared outcomes in patients that had observation only, radiation, or surgery. Age-related 5-year survival in patients with stage I lung cancer having surgery was excellent with lung cancer specific mortality 19% (<65), 26% (65-75), and 30% (>75). Results with surgery in stage II patients were similar. In patients receiving radiation only, 5-year lung cancer specific mortality was greater than 60% for all three groups.

Comments:

This retrospective data analysis provides powerful support for surgical intervention in those elderly patients with early stage lung cancer who are surgical candidates. The survival outcomes for patients treated with radiation only need to be interpreted with great caution because of presumed selection bias.

 

New England Journal of Medicine May 23, 2013

“Results of Initial Low-Dose Computed Tomographic Screening for Lung Cancer”

Study:

Over 50,000 individuals with at least 30 pack year history of smoking, from 33 different centers, were randomized to either CXR of CT of the chest to screen for lung cancer on an annual basis for 3 consecutive years. Plan design was interesting in that for CT screening purposes a positive screening result was defined as the presence of non-calcified nodules 4mm or greater in diameter. For plain film of the chest, all nodules seen were considered a positive finding for screening purposes.

Results:   

CT screening was positive in over 27% and CXR screening was positive in 9% of study participants. Lung cancer was ultimately diagnosed in 1.1% of study participants screened by CT and in 0.7% of participants screened by CXR. The authors of this very important study comment that the difference in lung cancer diagnosis rates was almost completely attributed to the higher incidence of stage IA lung cancer found by low dose CT imaging of the chest.

Conclusion:

Because of the larger number of patients diagnosed with stage IA lung cancer, the authors concluded that screening with low dose CT of the chest may result in increased lung cancer survival.

Comment:

The results of the study and implications for potential lung cancer survival are consistent with other studies. Cost-benefit analysis will likely be a moving target in favor of screening, as the cost for low dose screening CT of the chest is anticipated to drop.

To discuss this, or any of Dr. Mamus's other topics, please don't hesitate to contact him.

 

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08 July 2013, 15:30
 

Cancer Answers New Treatment Alternatives in Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma (NHL) – Update From American Society of Clinical Oncology (ASCO), Chicago 2013

Category: Leukemia

Idelalisib (GS-1101) was the subject of multiple abstracts at ASCO.

The agent has activity when:

(1)  Abstract 7003 combined with rituxan (R) and or bendamustine (B) as first line therapy in indolent NHL – phase I

(2) Abstract 7005 combined with R as front line therapy in CLL or small lymphocytic lymphoma (SLL) – phase II

(3) Abstract 7017 single agent in relapsed or refractory chronic lymphocytic leukemia patients – phase III

(4) Abstract 7131 combined with ofatumumab for previously treated CLL – phase III

(5) Abstract 8579 signal pathway study

(6) Abstract 8526 single agent, relapsed or refractory NHL – phase I

(7) Abstract 8500 with R and/or B in patients prior treatment of indolent(i)NHL – phase I

(8) Abstract 7133 with B and R for previously treated CLL – phase III

(9) Abstract 8618 with B and R for previously treated iNHL – phase III

(10) Abstract 8519 single agent relapsed or refractory mantle cell lymphoma (MCL)

(11) Abstract 8501 combined with everolimus(S), bortezomin(B), or B/R in previously treated MCL

Comment: The most interesting studies were abstracts 8519 and 8501. It appears that Idelalisib is active in patients with previously treated MCL; however durability of response and toxicity when combined with other agents was significant. Time on study was extraordinarily brief particularly noteworthy in abstract 8501.

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05 July 2013, 13:25