Category: Harvard affiliates

How Boston medical centers prepare for unconventional weapon attacks

Interviewed by Steven E. Greer, MD

Paul Biddinger, MD, Medical Director for Emergency Preparedness, Massachusetts General Hospital and also Chairman of the Massachusetts Medical Society’s Committee on Preparedness, discusses how his hospital prepares and trains for the event of chemical and nuclear (dirty bomb) attacks.


The Massachusetts General trauma response to the Boston bombings

Interviewed by Steven E. Greer, MD

Paul Biddinger, MD, Medical Director for Emergency Preparedness, Massachusetts General Hospital and also Chairman of the Massachusetts Medical Society’s Committee on Preparedness, discusses how his hospital, and all of Boston, responded to the several hundred severely injured patients after the Boston terrorist bombs. Lesson from the battlefield helped saves lives, as did the fact that Boston possibly has more Level 1 trauma centers than any other city in the world.

Atul Gawande’s surgical checklist fails in real world study

March 15, 2014- By Steven E. Greer, MD

In 2009, Atul Gawande, MD, MPH and his large international team published in the New England Journal of Medicine (NEJM) an observational study that showed a significant reduction of death and “complications” after non-cardiac surgery. The World Health Organization (WHO) created the checklist used in the NEJM paper. After this non-randomized, non-controlled, observational study was published, entire nations adopted the surgical checklist system.

Now, in 2014, a population study drawing from Ontario surgical patient data, published in the NEJM, showed no significant benefit from the widespread adoption of the same WHO surgical safety checklist that Dr. Gawande popularized. This study was also observational, but it was stronger than the 2009 Gawande study in that it included the entire population within a region.

What went wrong? Read more »

Don Berwick, MD: State health insurance exchanges

Don Berwick, MD: Waste in the American Healthcare System

Dr. Berwick, former Director of CMS and former President and CEO of IHI, discusses the percentage of waste in the American Healthcare System. He also mentions the new proposals by nine specialties recommending that 45 procedures and tests be performed less often as they are almost always unnecessary.

Don Berwick, MD: Changing from fee-for-service to bundled payments in Medicare and Medicaid

The Damon Runyon Cancer Research Foundation panel

March 8, 2013  By Steven E. Greer, MD

We interviewed three of the oncologists and industry executives who spoke at the Damon Runyon Cancer Research Foundation in Cambridge, Massachusetts in March. They were:

  • Richard B. Gaynor, MD, Chair, Accelerating Cancer Cures; Vice President, Cancer Research/Clinical Investigation, Eli Lilly
  • Michael J. Vasconcelles, MD, Senior Vice President, Oncology Clinical Development Millennium; The Takeda Oncology Company
  • Catherine Wu, MD, Dana-Farber Cancer Institute

The first topic of discussion was Read more »

Will healthcare spending really continue at its current pace?

Interviewed by Steven Greer, MD

The consensus among government budget forecasters such as the CBO is that the current growth rate of healthcare spending will continue and result in healthcare becoming 30% of the GDP. It is not well appreciated that the CBO is often very inaccurate because the models their staff use incorporate past or current growth estimates in perpetuity. In contrast, Wall Street financial analysts are paid to make the tough judgment calls that tweak future-year growth estimates based on fundamental analysis.

With the various healthcare reform proposals being “scored” by the CBO now, the issue of whether healthcare will indeed balloon out of control is of vital importance. The HCC interviewed Harvard economics professor David Cutler who takes a contrarian view that healthcare spending will slow and perhaps decrease due to a variety of factors.

Benjamin Sommers, MD PhD: Expansion of Medicaid and impact on mortality rates

Reasons for permanent slowdowns in healthcare spending growth

May 17, 2013- Interviewed by Steven E. Greer, MD

Since 2010, the rate of growth in healthcare spending has been the lowest in decades, even slower than the HMO era of the 1990′s. This had been attributed simply to the recession, but fundamental changes to Medicare and private insurance have taken place, as well as changes to costly new technology (e.g. medical imaging, prescription drugs, etc).

Analyzing all of this, David Cutler, PhD, Harvard economist and White House advisor, recently published a paper in Health Affairs. We interviewed him. In Part 1, he gives a general overview. In Part 2, we discuss in more detail bundling, high-deductible insurance, tiered drug formularies, and other specific changes that have been taking place.

Questionable comments by Atul Gawande after the Boston Marathon bombings

April 20, 2013 By Steven E. Greer, MD

Only two days after the April 15th Boston Marathon terrorist bombings, Harvard surgeon Atul Gawande posted an online essay in The New Yorker about the effective response from fist responders and the treating medical centers. Dr. Gawande is a cancer surgeon and was not part of the trauma responses.

In his New Yorker article, Dr. Gawande wrote, “We have, as one colleague put it to me, replaced our pre-9/11 naïveté with post-9/11 sobriety.” That was a profound statement and something that could become an iconic catchphrase, similar to Matt Taibbi’s famous quote in Rolling Stone referring to Goldman Sachs as, “A great vampire squid”.

On Saturday, April 20th, one day after the surviving bomber was arrested, Dr. Gawande was a guest on the CBS Morning Show discussing the remarkable medical responses from Boston medical centers. Once again, he used the excellent line, “We have replaced our pre-9/11 naïveté with post-9/11 sobriety.”, but this time, he failed to mention that those were not his own words. He left out “as one colleague put it to me”. Read more »

The Medicaid Roundtable

Part 1: Medicaid primer

Part 2: State spending on Medicaid

Part 3: Impact of Medicaid expansion to hospitals, states, and mortality

Part 4: Efforts by individual states to reform Medicaid away from fee-for-service

Part 5: Will other states adopt bundled payment plans for Medicaid and stop fee-for-service?

Part 6: What does the ACA ObamaCare law mean for Medicaid?

Part 7: Will individual state reforms of Medicaid lead to a more global reform of American healthcare?

Part 8: Impact the healthcare companies

Part 9: The outcome of the election and Medicaid/ACA law

FDA official, William Maisel, pleads guilty to crime, keeps job

April 24, 2013 By Steven E. Greer, MD

In July of 2012, the New York Times reported on an FDA scandal of the agency spying on internal whistleblowers, by hacking into their work and personal emails. The FDA employees who were the victims filed lawsuits, and The Healthcare Channel interviewed the plaintiff’s lawyer, Stephen Kohn.

One month later, a senior FDA official who was named as a defendant in the lawsuit above, William Maisel, MD, PhD (a former Harvard cardiologist), was a arrested in a Maryland suburb on five counts relating to soliciting a prostitute. The story was not reported well in the national press and the fate of Dr. Maisel at the FDA had been unknown. Read more »

Paul Richardson, MD: Current Therapies for Multiple Myeloma

Interviewed by Steven Greer, MD

Dr. Paul Richardson, Clinical Director of the Multiple Myeloma Center at Harvard’s Dana-Farber Cancer Institute gives an overview of the current standard of care for patients with multiple myeloma


Paul Richardson, MD: Three-drug regimen for multiple myeloma

Dr. Paul Richardson of Harvard’s Dana-Farber Cancer Institute reviews the recent Lancet article by Cavo, et al, that was the first randomized controlled trial to compare three-drug regimen (bortezomib plus thalidomide plus dexamethasone) to just thalidomide/dexamethasone. The complete response rates and progression free survival were significantly better in the three drug arm.


Don Berwick, MD: The Institute for Healthcare Improvement

Don Berwick, MD: National Coverage Decisions

National Coverage Decisions (NCDs) are used by CMS to set guidelines as to when certain therapies will be covered and reimbursed based on the best scientific clinical data. NCD’s tend to result in restricted usage of a formerly overused and costly therapy. Recently, two controversial therapies, Provenge for prostate cancer and the Edwards Lifesciences’ Sapien percutaneous aortic valve, have been restricted by NCD’s. We asked former Director of CMS, Dr. Don Berwick, whether this will be an increasingly used tool by Medicare to cut costs.

Benjamin Sommers, MD PhD: the challenges of expanding Medicaid

Interviewed by Steven Greer, MD

Under the ACA health insurance reform laws, approximately 16 million new Medicaid patients will be added to the system within a few years. Benjamin Sommers, MD PhD, Internist and Assistant Professor of Public Health at Harvard, discusses how some States with low enrollment in Medicaid will achieve these goals.


Jennifer Temel, MD, Vicki Jackson, MD: Early palliative care improves outcomes in lung cancer patients

Produced and interviewed by Steven Greer, MD

A group from Harvard published a paper in The NEJM that showed early initiation of palliative care in a group of lung cancer patients resulted in improved outcomes and a survival benefit comparable to chemotherapy studies. The trial was randomized. Both cohorts received chemotherapy, with one group having the additional palliative care. Interestingly, although the palliative care group had nearly a three-month longer median survival, the patients opted for less aggressive chemotherapy at the end of life.

In Part 1, medical oncologist Dr. Temel summarizes the paper.

In Part 2, Dr. Jackson, acting Director of Palliative Care at the Massachusetts General Hospital elaborates on the specific procedures and counseling provided.

Benjamin Sommers, MD PhD: Will more Medicaid patients stress the system financially?

Interviewed by Steven Greer MD

Under the ACA health insurance reform laws, approximately 16 million new Medicaid patients will be added to the system in a few years. Medicaid pays hospitals and doctors much less than Medicare and private insurance. Will increasing the mix of Medicaid increase the financial distress of medical centers?

Benjamin Sommers, MD PhD Internist and Assistant Professor of Public Health at Harvard addresses this question.


Actual tweets of Boston terrorist bomber Dzhokhar A. Tsarnaev

BomberApril 19, 2013- Below are the actual Tweets of the surviving Boston terrorist bomber, Dzhokhar A. Tsarnaev. He is a fan of HipHop culture, likely has no girlfriend but wants one, seems to be enrolled at a college, and follows Islamic sites.

His tweets are not too intelligent but typical of a 19-yo male in The U.S. He seems to be a student or unemployed young male, bitter with society, and easily brainwashed. He also seems to have traits of narcissism. Some of his twitter friends have posted Instagram photos of marijuana. He possibly likes crystal meth, or at least the thought of it, based on comments.

Interestingly, he seems to have at least one accomplice that he was tweeting in coded words, acknowledging the bombing and wishing them luck.


Some selected tweets from months ago….

Jahar ‏@J_tsar 5 Dec something light for lunch

Jahar ‏@J_tsar 7 Dec Once my teacher said she accepts all late work without penalties, 1. I fell in love with her and 2. It was my cue not to do shit until now Read more »

60 Minutes: Is Sugar Toxic?

The Medicare CMMI pork project needs to be nipped in the bud

For PDF version, click here CMMI needs to be dismantled

May 27, 2012  By Steven Greer, MD

The Supreme Court will soon announce its ruling on the constitutionality of the PPACA “Obamacare” law that was enacted as a federal clone of the Massachusetts “Romneycare”. Several entirely new government entities and bureaucracies were created in the law, including the new CMS division called The Center for Medicare and Medicaid Innovation (CMMI).

I was a Chairman of the grant review process for CMMI, and can tell you from firsthand experience that the program is nothing but a pork program that diverts untouchable Medicare entitlement funds to political cronies in key states. Regardless of the imminent Supreme Court ruling, the CMMI should be dismantled and de-funded by congress.

As the name describes, CMMI was created ostensibly to find ways to deliver Medicare and Medicaid in smarter, more “innovative”, ways than the current fee-for-service system that encourages waste and harmful programs. The PPACA law created the CMMI with $10 Billion in funding over ten years. But like most government programs, it was immediately hijacked and corrupted by the politicians.

Dr. Gilfillan

After passage of the PPACA, the acting Administrator of CMS, Donald Berwick, MD, oversaw the creation of CMMI, and Richard Gilfillan, MD was chosen as the Director. Prior to running CMS, Dr. Berwick was the well respected and controversial CEO of the Boston healthcare policy think tank called IHI. It was during his days at IHI that Dr. Berwick made comments supporting comparative effectiveness, and other ideas used by the UK’s single-payer healthcare system, that later were use against him by the Republicans in congress to prevent his permanent nomination to be the director of CMS (Much was at stake. CMS has the largest budget in the federal government, exceeding that of the military). Dr. Berwick is now back in Boston working out of the IHI offices.

I became involved with CMMI in January of 2012 when I received an invitation from CMMI to participate as a reviewer of the grants. I sent in my CV and was selected to be a Chairman overseeing a group of reviewers.

Having written numerous other federal grant applications as a medical researcher, I was immediately surprised and confused by the very short time allotted for us to review 12 applications, each of which was more than 100 pages. I was selected as Chairman in February 15th, and I had only until February 29th to assemble a team of reviewers, host conference calls, then collect the completed scores. In contrast, an NIH grant receives many months of thoughtful review by scientists who are well regarded in their fields. Two weeks to do all of this was absurd.

I began to suspect that Medicare was not exactly interested in high quality input from the grant reviewers, to say the least, and that it was all just a cover for something else nefarious in nature. What exactly that was, I did not know at the time, but the red flags were raised in my mind.

To make matters more challenging for my review team, the online digital system called ARM that CMMI was using to handle our grant reviews was malfunctioning. CMMI contracted with the private company called Laurel Consulting Group based in Arlington, Virginia. The ARM system was deleting the painstaking time consuming review scores that our reviewers were inputting. At first, I assumed the reviewers were making mistakes, but when a reviewer resigned and I picked up his workload, I saw how my own data were being deleted.

Eventually, all but one of our reviewers resigned due to the problems with ARM, and also because the time required was far greater than any of us expected when we signed up as volunteers (e.g. reading and evaluate 1,200 pages in two weeks, attending conference calls, etc). I reported the problems to CMMI and to the private company. Laurel Consulting essentially accused me of lying, claiming that we must not have really entered the grant review scores and comments. After that, I too then left the program. Since all of the review teams used the same ARM system, it is quite likely that the other 3,000 CMMI grants were improperly reviewed, meaning your tax dollars were misallocated.

After my bad experience, I sent a memo to CMS’s person in charge of CMMI, Dr. Gilfillan, and also to the Secretary of the HHS, Kathleen Sebelius, which received no reply. I also sent a summary of my experiences to some national news outlets, but none of them paid any attention back in February.

A few months went by, and on May 8th, 2012, the list of the first group of CMMI grant recipients was awarded. Only 26 out of more than 3,000 applications were funded, and the conservative press pounced when favoritism was evident.

The one program receiving the most conservative press coverage, due to its ties with close friends of President Obama, was the Chicago Urban Health Initiative. The CMMI funding summary states, “Funding amount: $5,862,027. The University of Chicago Urban Health Initiative…is receiving an award to develop the CommunityRx system, a continuously updated electronic database of community health resources…The program will serve over 200,000 patients on the South Side of Chicago most of whom are Medicare, Medicaid and CHIP beneficiaries.  The CommunityRx system will train and create new jobs for an estimated 90 individuals from this high-poverty, diverse community.  This includes high school youth who will to collect data on community health resources as part of the Urban Health Initiative’s MAPSCorps program. It will also include the creation of a new type of health worker, Community Health Information Experts (CHIEfs), who will assist patients in using the Health.eRx and engage community-based service providers in meaningful use of the CommunityRx reports.  The CommunityRx builds on infrastructure supported by ARRA funding from the National Institute on Aging. Anticipated outcomes include better population health, better use of appropriate services, increased compliance with care, and fewer avoidable visits to the emergency room with estimated savings of approximately $6.4 million.

The conservative National Review wrote, “The Chicago program, known as the Urban Health Initiative, is run by one of President Obama’s closest golfing buddies, scandal-magnet Eric Whitaker, who has been entangled with Illinois corruption celebrities Rod Blagojevich and Tony Rezko over the past decade.”

Prior to this media coverage on the 26 CMMI grants awarded, something far more concerning occurred. While Dr. Berwick was still acting as the Administrator of CMS and overseeing the creation of CMMI, the Partnership for Patients was created as the first program within CMMI, with $500 Million in funding. On the CMMI website it states, “Launched in April 2011, the Partnership for Patients is a nationwide public-private partnership that offers support to physicians, nurses and other clinicians working in and out of hospitals to make patient care safer and to support effective transitions of patients from hospitals to other settings. The Community-based Care Transitions Program tests models for improving care transitions in order to reduce hospital readmissions.”

One might think that the mission of the Partnership for Patients seems like a very noble use of federal funds, and it might very well be. But a major conflict of interest and ethical breach was created when The Health Research and Educational Trust, or HRET, was awarded a grant from the CMMI, and then, in turn, awarded a subcontract to the CMS Director’s own IHI in Boston. This has not yet been reported in the press and is an exclusive news story. I learned of it from a source involved in the Partnership for Patients process.

I asked Dr. Berwick to confirm the subcontracts between his IHI and HRET and he replied, “I don’t think there are contracts between them, but they’re good friends.” Dr. Berwick is careful to make it clear that he is now no longer the CEO of IHI, yet he does go to work in the Boston offices of IHI.

To have CMS money flow to the company where the director of CMS was formerly the CEO for 19 years smacks of favoritism and corruption, and is reminiscent of the controversial Defense Department contracts to Dick Cheney’s former employer, Halliburton. However, to be sure, if CMMI somehow survives the ruling of the Supreme Court, and if a Republican is elected as president, then the GOP will almost certainly use CMMI as a tool to distribute political favors just as has the Obama administration. This is another reason that the CMMI needs to be dismantled.

Cronyism and pork projects aside, let’s assume for a moment that the CMMI grants were awarded via a squeaky clean peer-review system based purely on merit, then the CMMI would still be an ineffective waste of taxpayer dollars. That is, if the first 26 grants are of any indication. The aforementioned Chicago Urban Health Initiative program is purely a job creation program for urban underprivileged youth in Chicago. Also, as another example, the $5 Million given to The Center for Health Care Services in San Antonio is another job creation program, at best, and does not “innovate” anything.

As I looked at the summaries for each of the 26 winning grant programs, not one of them seems to be able to truly change the Medicare fee-for-service culture, but rather are simply additional spending pork programs. The term “Innovation” in the name CMMI seems to be a euphemism for “jobs programs”. If any of those program applications would have been assigned to my group, I would have given them low scores as a chairman of the review process.

The CMMI web site that lists the details of the 26 grants awarded also lists the estimated savings to CMS that each program will provide, therefore offsetting the initial costs. The financial accounting methods used are unknown. I am a professional financial analyst that advises the largest institutional investors in the world, and an expert on the financial models for the largest healthcare companies, having built the excel spreadsheets. I can tell you that it is pure hocus-pocus for CMMI to estimate that any of the 26 programs will save money. I challenge CMMI to explain to me how they derived those forecasts. Moreover, estimating cost savings was not part of our review process, so this must have been calculated internally by the CMMI group.

I can also say for certain that the 12 grant applications which I personally oversaw were egregiously designed thinly veiled requests for handouts that offered no “innovation” whatsoever. For example, one was submitted by a for-profit company that offered a holistic healing process through human touch.

Dr. Berwick himself has said that up to a third of all CMS spending goes to waste or fraud. The newly created CMMI is nothing but a stealth stimulus plan to help job creation and politicians’ careers, just like the extremely ineffective ARRA “stimulus plan” was in 2009. The ARRA did nothing to reduce unemployment, and neither will the much smaller CMMI.

The CMMI is a very bad idea. If the Supreme Court does not nip this in the bud, then congress should do so. That is my informed opinion as an insider to CMMI.

How to cut healthcare costs in Massachusetts: ban Harvard from insurance plans

Massachusetts Governor Patrick discusses how they are cutting healthcare costs by encouraging limited network plans that do not include Harvard and other teaching hospitals, as well as getting away from fee for service

William Maisel, MD, MPH: Reforms for the medical device 510K and PMA process

Update: January 19, 2011

Dr. Maisel is now a Deputy Director within the medical device division of the FDA, CDRH.

June 26, 2009

Dr. William Maisel of the Harvard system has chaired several FDA advisory committees for the approval of medical devices and runs the Medical Device Safety Institute. He recently testified before congress about reforms needed in the way medical devices are approved under the PMA process, and even less rigorous 510K process. Dr. Maisel discusses these topics.


Mark Josephson, MD: ICD risks versus benefits

Mark Josephson, MD, Chief of Cardiology at Beth Israel Deaconess Medical Center in Boston, discusses ICDs and their risks.

Conflicts of Interest in Medicine

Produced and interviewed by Steven Greer, MD

The Institute of Medicine (IOM), part of the National Academy of Sciences, issued in April a much-awaited report recommending guidelines for how doctors and medical societies should handle and report industry support and payments.

We interviewed one of the authors, Dr. Eric Campbell of Harvard

Face transplant results

One year after face transplant

60 Minutes story that antidepressants no better than placebo

Bruce Chabner, MD: Industry reasons for the critical shortage of generic cancer drugs

November 10, 2011

By Steven Greer, MD

President Obama issued an executive order to the FDA and DOJ to immediately begin certain steps aimed at resolving the critical shortage on injectable generic drugs. Cancer drug shortages have received the most press attention, but other injectables, such as the anesthetic propofol, common IV solutions, TPN, antibiotics, etc. are all in short supply. Making matters worse, unscrupulous gray market stockpilers are practicing in price gouging.

To learn more about the root causes of these shortages, and the specific plans of actions that the FDA and DOJ will take, we interviewed Bruce Chabner, MD, Director of Clinical Research, MGH Cancer Center, Massachusetts General Hospital

Blake Cady, MD: Evidence to support routine mammography

Breast cancer surgeon Blake Cady, MD discusses the body of evidence that shows early and routine screening for breast cancer using mammography dramatically lowers deaths rates.

“Medical meetings” still not adhering to industry bias guidelines

May 7, 2011

ProPublica’s healthcare team recently posted an interesting multimedia graphic that shows where healthcare companies allot the advertising and “educational” monies for the ongoing Heart Rhythm Society Meeting. Notable spending at this meeting goes for attendee bag inserts and pamphlets.

CurrentMedicine.TV previously interviewed Harvard’s Eric Campbell and UCSF’s  David Wofsy about the IOM guidelines for medical societies relating to industry payment bias. It appears as if the HRS meeting is not coming close to adhering to these recommendations, based on the ProPublica story.

Their video interviews can be viewed here.

In addition, the huge ASCO meeting last year was also ignoring the IOM industry guidelines.

Geographic variations in healthcare spending per patient

September 28, 2010 Update

Dr. Epstein was selected to be on the board of the newly created PCORI. This is the $30 Billion-funded comparative effectiveness research institute created by the ACA healthcare reform law.

June 1, 2010

Arnold Epstein, MD, Chair, Department of Health Policy and Management at the Harvard School of Public Health discusses his editorial in the NEJM that reviews the last 40 years of research on the topic of how some regions of the country, mostly coastal cities, spend more per patient on healthcare and do not achieve better outcomes.

Specific topics include:

  • Summary of the 40 years of research on Medicare geographic spending variations
  • Does greater spending on medical services per patient translate into better health outcomes?
  • If outcomes are not better with greater spending, what drives the increased spending in these coastal geographic regions? Is it unnecessary procedures and tests, fraud, etc?
  • Do the bulk of these differences in spending per patient take place in the last year of life?
  • Will the new healthcare reform law (ACA) help CMS and private insurance reduce wasteful spending?
  • What are some specific provisions that would reduce geographic healthcare spending differences?
  • Will Comparative Effectiveness measure mandated by recent legislation help lower healthcare

Is ASCO abiding by IOM ethics guidelines?

June 4, 2010

Op-Ed The Healthcare Channel

The Wall Street Journal’s Ron Winslow posted a blog essay about the extraordinary embargo confusion caused by the ASCO press corps. The story received considerable favorable reviews by healthcare journalists commenting on Twitter, etc. In previous years, other journalists from large national news companies have expressed similar frustration with the annual ASCO meeting. CNBC’s Mike Huckman was actually removed from the convention hall one year for allegedly setting up his cameras and reporting from within the conference hall.

Why is the ASCO meeting so secretive and opaque? True science is supposed to be freely disseminated in a transparent fashion. Oppressive rules of embargo for the media, and the banning of cameras during the meeting, are antithetical to a true “scientific meeting”.

Smaller freelance journalists and “new media” outlets have to overcome even greater hurdles with ASCO than the larger organizations such as WSJ and CNBC. For example, The Healthcare Channel is accepted as legitimate “news media” by organizations with the  highest standards in the land, ranging from the U.S. Senate media office to the White House press office. Every major journal, including the NEJM, JAMA, Lancet, Circulation, Annals of Internal medicine, etc grant The HCC media access, yet ASCO’s Journal of Clinical Oncology does not.

The ASCO press office does not acknowledge The HCC as being legitimate news. Arbitrary reason have been given by ASCO, such as “The HCC does not provide editorial content”, whatever that means. In fact, “editorial content” like the O’Reilly Factor is precisely the type of media that is NOT accepted as “news” by the White House, etc.

The HCC has reported numerous times over the last several years how the ASCO meeting has been conducted in questionable ways.  In 2007, The HCC reported on the favorable attention a “late breaking” breast cancer trial received and questioned the influence of the large sponsor Genentech. In 2008, The HCC discussed the controversial way that ASCO released its abstracts. This reporting has undoubtedly dis-ingratiated The HCC with the lobbying staff of ASCO.

In 2009, the IOM issued ethical guidelines for how large medical societies that take money from the drug and device industry, such as ASCO, should handle their annual meetings. The HCC interviewed one of the authors, Dr. Eric Campbell of Harvard. A similar guidelines was published in JAMA. The HCC interviewed one its authors, Dr. David Wofsy of UCSF.

The 2010 ASCO meeting should be held to these ethical guidelines. Per the video interviews above, will the 2010 ASCO meeting:

  • Ban all satellite educational symposium that serve as marketing meetings for the drug companies?
  • Ban all branded gift items such as pens and bags?
  • Ban the acceptance of any drug industry cash from any ASCO official?
  • Ban the acceptance of any drug industry cash from any member of a “guidelines committee”?
  • Restrict total ASCO funding from the drug industry to less than 25% of the total revenue?
  • Ban the selling of ASCO member email and addresses to drug marketers?

William Maisel, MD: discusses the Medical Device Safety Institute

The medical device industry has been replete with safety recalls and scandals at the CDRH device section of the FDA. Cardiologists have had to deal with most of the highest profile problems ranging from ICDs to drug eluting stents. As a result, cardiologist William Maisel of the Beth Israel Deaconess Medical Center founded the Medical Device Safety Institute.

Elliott Antman, MD: TIMI 38 prasugrel study and stent thrombosis subsets

Elliot Antman of Brigham and Women’s Hospital discusses a subset analysis of the stent thrombosis cases for Effient (prasugrel)

Kenneth Baughman, MD: a biography by Dr. Roger Blumenthal

Kenneth Baughman, MD, prominent Harvard and Johns Hopkins cardiologist, was tragically killed this month during his morning jog when he was struck by a car. Dr. Baughman was in Orlando for the AHA meeting. One of his pupils, Dr. Roger Blumenthal of Johns Hopkins, discusses Dr. Baughman’s accomplished career.

William Maisel, MD MPH: The MADIT CRT trial

Dr. William Maisel of Beth Israel discuss the design of the MADIT CRT trial and what the data will mean to the ICD CRT market. The study looked at less sick NYHA Class 1 and Class 2 heart failure patients with wide QRS and low EF. The outcome measure was a combined endpoint of heart failure hospitalizations and death.

Dr. Maisel is enthused by the data and discusses the cost associated with heart failure admissions. If CRT devices cut back on readmissions then they will be financially beneficial.

Of note, the study was not blinded to the cardiologists which is important since the decision to admit a patient for heart failure is subjective and impacted by whether a CRT was implanted versus an ICD. When the full data are presented, it will be crucial to look at the mortality data to determine whether they show a statistically significant benefit. If the combined endpoint was driven to significance by the hospitalization parameter, then the data are suspect.

Elliott Antman, MD: TIMI 38 and prasugrel

March 3, 2008 The Healthcare Channel

One of the more important presentations at the upcoming American College of Cardiology meeting later this month will be a subset analysis of the stent thrombosis cases for Eli Lilly’s blockbuster hopeful prasugrel. Prasugrel would ideally compete for Plavix in the lucrative anticoagulation market. The FDA decision on prasugrel will also be one of the most important events this year in cardiology from a pharmaceutical perspective.

We interviewed the lead author for the TRITON-TIMI 38 study, Elliot Antman of Brigham and Women’s Hospital. The study was presented at the AHA last year and published in the NEJM.

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