Category: Harvard affiliates

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.

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 »

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.

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Some selected tweets from months ago….

Jahar ‏@J_tsar 5 Dec something light for lunch pic.twitter.com/CvAiNXi

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 »

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

httpv://www.youtube.com/watch?v=DY6VhVEyzT0

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.

httpv://www.youtube.com/watch?v=HoldMF3dZCo

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

httpv://www.youtube.com/watch?v=NyN-J5G2HKw

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.

Face transplant results

One year after face transplant