Joint Pain

10/03/2011 08:18 AM |

In April, the Food and Drug Administration approved a first-of-its kind study to test whether marijuana can ease the nightmares, insomnia, anxiety and flashbacks common in combat veterans with post-traumatic stress disorder.

But now another branch of the federal government has stymied the study. The Health and Human Services Department is refusing to sell government-grown marijuana to the nonprofit group proposing the research, the Multidisciplinary Association for Psychedelic Studies.

 

The HHS official in charge of the review, Sarah A. Wattenberg, declined to answer questions when reached by phone.

 

Can you imagine the hue and cry if this had happened under the previous administration?

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Peering over the Health Cliff

09/30/2011 10:18 AM |

Embed head firmly in sand and repeat after me in your best Dorothy in Oz cadence, “Pens and Pizza and Biscuits. Oh my!”

 

Now consider this new British Medical Journal commentary piece by Iona Heath, the president, Royal College of General Practitioners” --

The politics of drug industry sponsorship
 

Earlier this month I received a letter from a senior politician inviting me to attend a meeting on a public health topic … I failed to notice that the letter included the sentence: "The meeting is being supported by the healthcare company, Bristol-Myers Squibb." However, when I arrived, the tabled agenda had a similar sentence across the bottom: "The logistical aspects of this meeting are being supported by Bristol-Myers Squibb (BMS)."

 

The usual round of introductions revealed that there were two representatives of the company in the room listening to everything that was being said … Although I welcome unreservedly the transparent disclosure, when I tried to express concern about the process, the said politician assured me, more than a little abruptly, that it was only the coffee and the biscuits … Not surprisingly, the biscuits were much more tempting than usual … Sadly the politician in question seemed not to be aware of the relevance of any of this to the coffee and biscuits.

 

Dr. Heath’s complete commentary can be found here. 

 

Sadly Dr. Heath (while certainly entitled to her opinion and desire to tow the party line) seems unaware of the evidence to the contrary.

 

For example, in the January 2010 issue of Academic Medicine (Adad. med. 2010; 85:80-84), four researchers from the Cleveland Clinic published a paper entitled, "The Effect of Industry Support on Participants of Bias in Continuing Medical Education."  The purpose of the study:  "To obtain prospective evidence of whether industry support of continuing medical education affects perceptions of commercial bias in CME."

The method:  "The authors analyzed information from the CME activity database (346 CME activities of numerous types; 95,429 participants in 2007) of a large, multi-specialty academic medical center to determine whether a relationship existed among the degree of perceived bias, the type of CME activity, and the presence or absence of commercial support."

The study's conclusion:  "This large prospective analysis found no evidence that commercial support results in perceived bias in CME activities.  Bias level seem quite low for all types of CME activities and is not significantly higher when commercial support is present."

Further, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) have adopted a new policy regarding the disclosure of conflicts of interest. Here's the key paragraph:

"There is no inherent conflict of interest in the working relationships of physicians with industry and government.  Rather, there is a commonality of interest that is healthy, desirable, and beneficial.  The collaborative relationship among physicians, government, and industry has resulted in many medical advances and improved health outcomes."

What a unique perspective -- a "commonality" rather than a "conflict" of interest.

 

And in a recent editorial in The Lancet, Richard Horton points out that the battle lines being drawn and between clinician, medical research, and the pharmaceutical industry are artificial at best—and dangerous at worst. They are dangerous, because all three constituencies are working towards the same goal—improved patient outcomes.

His point is that we must dismantle the battlements and embrace of philosophy of “symbiosis not schism.” It’s what’s in the best interest of the patient.

Nature Biotechnology puts it this way, “The great unspoken reality is that relationships between companies and researchers are not only becoming the norm, but they are also essential for medicine to progress.”

Suffice it to say that we disagree with Dr. Heath’s position – but we will certainly defend her right to have an opinion and express it.

Alas, the same cannot be said for another fellow traveler – Dr. Steve Nissan.

Recently my friend and co-conspirator Dr. Tom Stossel (the American Cancer Society Professor of Medicine at Harvard, and Director of the Translational Medicine Division of the Brigham and Women's Hospital) was invited to give a Grand Rounds lecture given at Case Western University. Here’s the verbatim e-mail that Dr. Nissen sent to his colleagues at Case Western:

“This guy is an embarrassment to the medical profession. Can’t believe you would have him provide Grand Rounds.  Your trainees deserve better.”

Talk about professional discourtesy!

The good news is that Tom’s lecture was standing room only.

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Apple at its Core

09/28/2011 10:05 AM |

Yesterday I was honored to attend and participate in the 2^nd annual Galien Forum (part of the Prix Galien celebration).  The topic under debate for my panel was, “What is value and how can it be measured and demonstrated in therapeutic innovations?”

I was joined on the dais by Jeff Berkowitz (SVP, Pharmaceutical Development and Market Access, Walgreens; Robert Epstein, Chief Clinical Research and Development Officer, Medco; Barry Gertz, SVP, Head of Clinical Research and Regulatory Affairs, Merck; and Roger Longman, CEO, Real Endpoints.  Our moderator was Dick Pasternak, a former Merck VP, Harvard Medical School associate professor and past director of Preventive Cardiology at Mass General).

The combination of a meaty topic and a high-octane panel made for a robust conversation. When the video of the panel is available, I will post it.

The audience was engaged and one question was particularly thought provoking. Not surprisingly, it came from Nobel Laureate Dr. Michael Brown (Professor of Molecular Genetics and Internal Medicine at UT Southwestern Medical Center and a board member of Pfizer).  Dr. Brown asked why innovative companies like Apple have such high public esteem while innovative pharmaceutical companies are at the other end of the spectrum of public opinion.

Perhaps the answer (or at least a piece of the answer) is that Apple defines itself in terms of innovation and the value it brings.  How, in contrast, do pharmaceutical companies (and the people who populate it) define themselves?  Too many see their jobs as “selling drugs.”  And while that is certainly a part of it (and an important and worthy part at that) should that be how they define their jobs and their employers? 

Until and unless pharmaceutical companies and their employees define themselves as being in the advancing healthcare business (as all their mottos proclaim), they will not be given the credit for the innovation that they truly deliver.

Many believe such image issues are the responsibility of PhRMA.  And while the trade organization certainly has an important role to play, ask yourself this – does Apple rely on its trade association to promote its innovativeness?

Another panel featured (among others) Dr. Steve Nissen on the topic of “Perspectives on Innovation, Patient Safety and Global Access.”  Here’s one direct quote from Dr. Nissen:

“No one should ever stop taking a medicine because of something they saw on television.”

Please pass the remote.

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It's always Sonny in Philadelphia

09/27/2011 10:44 PM |

“Every time I put my line in the water I said a Hail Mary, and every time I said a Hail Mary I caught a fish.”  Fredo Corleone

To use a pop culture metaphor, if IPAB is Michael, MedPac is Fredo.

The Medicare Payment Advisory Commission (aka – MedPac, the body that advises Congress on Medicare payment policy) is proposing to fix the Sustainable Growth Rate by sharing the cost of repealing the SGR among physicians, other health professionals, providers in other sectors and beneficiaries.

MedPAC’s draft plan suggests instituting a 10-year payment rate freeze for primary care physicians and three years of reduced payments at 5.9 percent each for specialists followed by a seven-year payment freeze. It also recommends offsets totaling about $235 billion. Those offsets would come from cuts to Medicare Part D drug plans (32 percent); post-acute care facilities (21 percent); Medicare benefits to seniors (14 percent); hospitals (11 percent); laboratories (9 percent); durable medical equipment (6 percent); Medicare Advantage (5 percent).

Not surprisingly, physicians are none too thrilled about the proposed cuts and freezes to their payment rates. In a statement, the American College of Surgeons said that, “The recommendations do not value the role all physicians have in the continuum of care and would have a devastating impact on access to surgical care.”

It certainly took long enough the physician community to stand up and speak out for patient care.  Too bad it took the harsh realities of the bottom line to do it. 

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Jerry Avorn's Assault on Minority Health

09/26/2011 09:17 PM |

Jerry Avorn is a big proponent of academic detailing -- the loose term for the government paying doctors and health professionals to discourage the use of new medicines.  He also profits from it because he has a company that is paid by government to engage in academic detailing.    Which is why he is chafing at the notion that his for profit business should be regulated in the same way the sales force of drug companies should be.  Can we say self-serving hypocrite?

Avorn claims that academic detailing is "evidence based medicine" put to use.  But their is very little evidence that anti-innovation detailing improves the health of patients.  There are no large scale clinical trials to look at the effect on health outcomes.   Or should we just take Avorn's word that his business model is better?   A study last year seemed to suggest that doctors who were subject to marketing to  use the guidelines from ALLHAT and prescriibe diuretics as the treatment of choice for high blood pressure were more likely to do so.  Let's ignore the fact that the claim diuretics reduced death as well or better than other drugs is based on based on secondary endpoints and that the primary endpoint (fatal coronary heart disease and nonfatal myocardial infarction) was similar for the 3 drugs. ALLHAT guidelines also hurt minorities: ALLHAT steered African-Americans to a combination of an ACE inhibitor and a [beta]-blocker in black patients.   Blacks randomized to an ACE-inhibitor  had 40% excess stroke rate compared to whites which explains the overall benefit of diuretics found in  ALLHAT.

So Avorn peddles a protocol whose design kills black patients.   He also opposed the FDA approval of  BIDil -- combination of two drugs that showed overwhelming reduction in death from heart failure among blacks until scientists conduct a study that tells us why white and black patients differ in response.  In doing so he ignored  3 well-controlled trials suggesting or showing a mortality benefit in black patients.   As the FDA noted in response to Avorn the was "apparently unimpressed by the 43% mortality risk reduction demonstrated.. and apparently believed that the racial difference hypothesis was based on a post hoc analysis of a single trial."  www.annals.org/content/146/1/57.full#ref-list-1

Actually Avorn is not only not unimpressed, he doesn't care.  He makes money pushing cheaper drugs and ignoring evidence that would undermine his racket.  If it harms minorities in the process, well that's just a cost of doing business.
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The Statin Quo

09/26/2011 08:51 AM |

Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely.

 

And not just because of certain high profile LOE dates.

 

A new draft guidance (issued Sept. 16^th) provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. The Pink sheet opines that “support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.”

 

“Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised.”

Can a patient self-diagnose and self-dose?  Do symptoms hide another, potentially more serious, underlying condition?  And what of safety concerns? 

Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.

 

A BTC category would almost certainly reopen the conversation about the “statin quo.”

In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.

This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.

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Dog Day Afternoon

09/23/2011 09:14 AM |

Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.

 

At the September 8^th meeting focused on efficacy data from the pivotal ROCKET AF study and whether the Factor Xa inhibitor was studied against an appropriate comparator. FDA sought the advisory committee’s input on whether warfarin or dabigatran was the appropriate comparator for rivaroxaban in light of a 1995 agency policy that requires new therapies be “as effective” as approved treatments when the disease at issue is life-threatening or capable of causing irreversible morbidity.

 

At a Sept. 8 meeting, the majority of panel members said Xarelto’s sponsors should not be required to directly show comparable efficacy to dabigatran, a drug approved 11 months ago.

 

According to the Pink Sheet, panelists commented that requiring drugs for serious or life-threatening diseases to be compared head-to-head against the newest treatment on the block could “throw a wrench in long-planned and ongoing clinical development programs that use a well-established standard of care as a comparator agent.”

 

Office of Drug Evaluation I Director Bob Temple on the question as to whether or not the ROCKET AF study population represented a sufficiently different group of patients from those in RE-LY as to render the “as effective” policy inapplicable to rivaroxaban:

 

“This was not my favorite question.” Dr, Temple then proceeded to point out the bigger issue inherent in applying FDA’s “as effective” policy in a dynamic development and regulatory environment.

 

“There is an interesting and provocative issue here. Suppose in the course of the study, something new and really hot comes along. Do we ever say, ‘I’m sorry, you compared it to a dog, we have something better now?’ We don’t usually do that, but I wouldn’t rule out the possibility. And this is a little bit about that possibility, but I don’t think we really meant to get too much into that discussion.”

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The Sizzle and the Stakeholder

09/23/2011 08:34 AM |

PCORI Executive Director Joe Selby wants to be clear that while the institute's main focus will be on patient-centered activities, it will wants participation from all interested parties.

 

"We want a director of stakeholder engagement to engage providers, caregivers, employers, health plans, health systems, health services researchers and other researchers, government and industry," Selby said September 19th during the PCORI Board of Governors meeting in Seattle.

 

Good idea.  And the selection process (and the selected candidate) should be carefully watched to see how Dr. Selby and the PCORI board defines “interested parties.”

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No Class Warfare

09/22/2011 06:50 AM |

Barak Obama is quickly becoming the anti-innovation President.

 

On Monday, the White House released its deficit reduction plan.  Part of the President’s strategy is to impose new rebates on Medicare drugs, strengthen the Independent Payment Advisory Board, and reduce the exclusivity period for innovator biologic drugs.

 

It’s not class warfare – it’s no-class warfare. And it’s deleterious to the public health.

 

As the Old Perfessor used to say, let’s look at the record.

 

First, on the topic of Medicare rebates, why don’t we just call it what it is – a tax.  More precisely, an excise tax imposed by Uncle Sam on drug sales.

 

But wait, it gets worse. The revenues from this tax don’t lower costs for a single patient.  Not one. The cash would go into the general fund.  It’s not a “rebate” – it’s a tax, plain and simple.  A levy imposed on price.

 

And, hiding behind “deficit reduction,” it’s a tax with a hidden purpose – the introduction of backdoor price controls.  And price controls equal cost controls – with or without IPAB.

 

Speaking of IPAB, the President's plan seeks to lower the threshold at which IPAB would impose Medicare spending cuts; however, the plan doesn't specify what the savings would be. So much for “specifics.” But, specifically speaking, a stronger IPAB further ices the slippery slope towards government price controls and (ultimately) a single payer system.

There’s already the very real risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the boardroom, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs. The President’s proposal makes this twice as bad.

And then there’s the anti-innovation codicil. The President wants to cut innovator biologics exclusivity to seven from the current 12 years.

It’s hugely disappointing that the same man who (as a United States Senator) once said that …

“Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."

 

… is now advocating a policy that would result in precisely the opposite.

 

After speaking (during the State of the Union and a widely quoted op-ed in the Wall Street Journal) about the need for America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.

Patent exclusivity funds an innovator company’s research and development efforts. If the President’s proposal becomes law, the US would provide less data protection for innovative biologics than Europe.

12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.

What’s next – an executive order instructing the FDA to approve biosimilars without clinical trials?  Alas – this is unfortunately not a far-fetched idea considering the tone and substance of President’s speech on Wednesday. 

If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”

 

As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."

 

L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning. Let’s keep our eye on the prize.  No, not budget reduction – the real prize: better access to smarter healthcare for all Americans.  Innovation that focuses on creating a chronic healthcare culture that embraces prevention and prophylactic care.  Rather than wasting time on spin, let’s redouble our efforts on innovation.  Then, when we succeed through brainpower and teamwork (and, hopefully some civil bipartisanship), the circus surrounding the President’s deficit reduction proposal will be but a footnote in the history of American healthcare.

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Science Or Celebrity?

09/21/2011 08:43 PM |

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Oh say can you C

09/21/2011 09:12 AM |

According to the New York Times, “Hospira, based in Lake Forest, Ill., which has been selling cheaper versions of expensive biologic drugs in Europe for nearly four years, said on Monday that it would begin a final-stage clinical trial in the United States by the end of this year of its biosimilar version of Amgen’s brand-name Epogen in patients with renal dysfunction who have anemia.”

 

Good news, right?  Well – yes. But ...

Yesterday at the 3^rd annual Business of Biosimilars & Biobetters Conference in Boston, Naomi Pearce (Director of IP at Hospira) gave a brutally tactical presentation on how to move forward with biosimilars via the “3 C’s – Challenge, Circumvent, Create.” 99.9% of her remarks focused on how to challenge and circumvent patents. The remaining .1% (under the heading of “create”) was limited to “and create something new when it makes good commercial sense.”

 

Ms. Pearce is a patent attorney and, of course, when you have a hammer every problem looks like a nail.  But it does point out many of those looking to enter the biosimilar space are looking at the opportunity as another “generics play.”  It reminds me of the time that Israel Makov (the founder and “Big Abba” of Teva) said to me that “Teva isn’t in the pharmaceutical business, it is in the litigation business.”

 

That was then and this is now?  Alas, not so fast.

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Me and Michelle Bachmann Talking About HPV Vaccines

09/20/2011 01:40 PM |

On different programs, not the same.   I was on Minnesota Public Radio .   She was on the-tonight-show.

Here are the links to the two performances.. I think I look better on radio than I do on TV.. But you decide.

minnesota.publicradio.org/display/web/2011/09/19/midmorning1/

www.nbc.com/the-tonight-show/video/michele-bachmann-part-2-91611/1355953/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-1-91611/1355952/
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UN summit on Non communicable diseases: avoiding HIV mistakes

09/19/2011 03:17 PM |

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Office Space

09/19/2011 11:36 AM |

Q: When is an office not an office?

A: When it's a super office.

FR:  Janet Woodcock

 

TO: CDER Staff:

 

The Office of Medical Policy (OMP) has been reorganized into a Super Office.  Within its organizational structure are the Office of Medical Policy Initiatives and the Office of Prescription Drug Promotion. Led by Rachel Sherman and her Deputy, Kathleen Uhl, OMP plays a critical role in directing medical policy programs and strategic initiatives.

 

This includes directing regulation of prescription drug promotion and advertising, providing leadership and scientific advice on clinical trial design, providing consultation and direction in policy issues related to human subject protection and good clinical practices, supporting the recent Health Care Reform Act that provides new legislation for Biosimilars, and developing regulation, guidance documents, and procedures related to medical policy issues.

 

·         Rachel Sherman, Director, Office of Medical Policy

·         Kathleen Uhl, Deputy Director, Office of Medical Policy

·         Janet Norden, Associate Director for Regulatory Affairs

 

The Office of Prescription Drug Promotion

 

The Division of Drug Marketing, Advertising, and Communications has been reorganized and elevated into the Office of Prescription Drug Promotion (OPDP).

This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion. 

 

ODPD consists of an Immediate Office, the Division of Professional Promotion (DPP), and the Division of Direct-to-Consumer Promotion (DDTCP). The new structure will help prevent misleading promotion about prescription drugs and enhance the quality of communications about prescription drugs and other health information developed by companies. 

 

Thomas Abrams, Director, Office of Prescription Drug Promotion

Mark Askine, Associate Director, Office of Prescription Drug Promotion

Marci Kiester, Associate Director of Operations, Office of Prescription Drug Promotion

Catherine Gray, Acting Director, Division of Professional Promotion

Robert Dean, Acting Director, Division of Direct-to-Consumer Promotion

 

The Office of Medical Policy Initiatives

 

A newly created Office of Medical Policy Initiatives (OMPI) consists of an Immediate Office, the Division of Medical Policy Programs (DMPP), and the Division of Medical Policy Development (DMPD).

 

This office will develop and coordinate medical policy regulations and guidances that address the policy and program areas covered by the Super Office. The organization of the divisions supports the continued implementation and successful advancement of the Sentinel Initiative, the Clinical Trials Transformation Initiative (CTTI), and the Patient Medication Information (PMI) Initiative. 

 

Within this reorganization, the Patient Labeling Team (PLT) will be moving from the Office of Surveillance and Epidemiology (OSE), Division of Risk Management (DRISK) to OMPI, Division of Medical Policy Programs. The goal of the Patient Labeling Team is to promote the safe and effective use of prescription medications by providing accurate and easily understood patient medication information. OMPI will reach out to affected offices with procedural details on the PLT's transfer.

 

Denise Hinton, Director, Office of Medical Policy Initiatives

Richardae Araojo, Deputy Director, Office of Medical Policy Initiatives & Acting Division Director, Division of Medical Policy Programs

Paula McKeever, Division Director, Division of Medical Policy Development

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Trigger Finger

09/19/2011 09:19 AM |

It seems that the FDA has decided that biosimilar sponsors will not be required to meet with the agency at specific times or for specific reasons during the IND phase of development, allowing them more flexibility early in the process.

 

Product development fees would be collected when a biosimilar sponsor files an IND. It is expected to be about 10% of the cost to file for a marketing application review and be charged annually as long as the product remains in active development stages.

 

FDA wants the earlier infusion of funding to support agency activities during the biosimilar IND stage, which are expected to be more extensive than those for other applications. The agency agreed to discount all product development fee payments from the marketing application fee once it is filed

 

FDA and the brand and generic industry representatives also may have ended their dispute over whether the biosimilar user fee program should be independent of the other user fee programs.

 

At an August 8th meeting the agency circulated draft statutory language authorizing creation of the program independent of other user fees. The minutes did not indicate opposition by GPhA on any portions of the proposal. There also was no mention in the minutes of further discussion of the appropriations trigger.

 

The agency agreed to write a draft commitment letter for discussion at another negotiating session, another indication both sides have moved beyond the issue.

 

 

The biosimilar user fee program is expected to be included in an omnibus bill that also will include the Medical Device User Fee and Modernization Act and PDUFA reauthorizations, as well as the new generic drug user fee program.

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A Challenge to Uncivil Society

09/16/2011 07:10 AM |

On Wednesday I attended the Washington Post’s event on non-communicable diseases (NCDs), “Sharing the Responsibility.” The event was co-sponsored by Eli Lilly & Co.

(Video clips of this event can be found at www.washingtonpostlive.com)

The title of the conference was crucial as world-class speaker after speaker spoke to the need for cooperation between (as Ann Keeling, the CEO of the International Diabetes Federation and Chair of the NCD Alliance put it) “the three P’s – public, private, and people.”

For a change, the discussion of NCDs wasn’t framed as a battle between “good guys” (generally portrayed in the mainstream media as “civil society”) and “bad guys” (private industry).  Rather than being about placing the blame, it was about developing solutions.  This position was stated early and eloquently by the event’s opening speaker, Dr. Julio Frank (Dean of the Faculty, Harvard School of Public Health and the key founding father of the Mexican healthcare system).  Dr. Frank warned that we must avoid and beware of “reductionist solutions.”

When asked about the role of intellectual property rights and their role in addressing the NCD issue, Dr. Frank said that protecting IPRs is crucial to developing new and innovative global healthcare solutions.  While he was answering this question, Ms. Keeling had no comment on the question of IPRs but did comment that, “there are no magic bullets.”

This concept of “shared responsibility” issues many challenges – not the least of which goes out to the “Uncivil Society” movement led by (among others) Jamie Love. Uncivil Society demonizes any role for industry -- except maybe writing checks (which brings to mind Abba Eban’s famous quote about the give-and-take between Israel and the PLO –“We give and they take.”)

As H.L. Mencken famously quipped, “For every complex problem there is an answer that is clear, simple, and wrong.”

Uncivil Society was called out at this event.  “Shared responsibility,” means they must cease repeating and repeating and repeating their incessant falsehood that the majority of the Developing World’s healthcare problems could be solved if only we would do away with patents and intellectual property protection.

The petty agenda of Uncivil Society must not be allowed to hijack the important global mission of combating NCDs.

During the panel on “Public & Private Partnerships,” Herb Riband (VP, External Affairs for Medtronic) spoke about a “confluence of interests.” And John Lechleiter (President and CEO, Eli Lilly & Co.) commented that, “There is no substitute for the power of partnership.” And Lilly is putting its money where its mouth is.  A day before the Post event they announced the Lilly NCD Partnership, a five-year $30 million commitment to fight the rising burden of non-communicable diseases in developing nations. And it’s not about writing a check, but rather combines the company’s resources with the expertise of leading global health organizations, to identify new models of patient care that increase treatment access and improve outcomes for underserved people.

As Mark Kramer (Senior Fellow, Harvard Kennedy School of Business) said, a key role for private industry is to “broker partnerships that propel progress.”

David Brown (a Washington Post journalist and a physician) commented that we must avoid the “false dichotomies” of NCDs (infectious vs. non-infectious, cure vs. prevention, rich vs. poor). So too must we avoid the false dichotomy of “hero vs. villain.”

The Washington Post conference, held in advance of next week’s historic United Nation’s High Level Meeting on NCDs, made it abundantly clear that, to actively, aggressively, and creatively fight NCDs in the Developing World (and, for that matter, the whole world), there must be partnerships rather than partisanship. 

The common ground is shared responsibility.

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Just Shoot Me

09/15/2011 09:21 AM |

Pseudo celebrity Jenny McCarthy has appeared on three episodes of the hit TV show "Just Shoot Me."  Ergo, her rants about the dangers of vaccines must be true, right?

Hm.

Please have a look at this short PSA on why, when it comes to vaccines, celebrity trumps science.

And please, pass this along.  Let's make it a YouTube sensation.
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CME -- No Evil

09/14/2011 06:52 AM |

If you have an interest and no pressing conflicts, two important briefings by the CME Coalition (www.cmecoalition.org) to consider attending:

CME Cancer Policy Briefing

On September 27, from 12:00 – 1:00 in the Rayburn House Office Building “Gold Room” (Room 2168), the Coalition will be presenting a program entitled “Continuing Medical Education:  A Focus on Breast Cancer Breakthroughs.”  This panel will comprise thought leaders in the fields of CME and breast cancer treatment, and will include:

Dr. Jonathan Sackier: Chief Medical Officer, Audax Health Solutions, Visiting Professor of Surgery, University of Virginia, Following positions at Cedars-Sinai and UCLA, he was named Professor of Surgery at George Washington University, in Washington, D.C. where he founded the Washington Institute of Surgical Endoscopy.

Dr. Charles Balch: Professor of Surgery and Oncology and Dermatology, Deputy Director, Johns Hopkins Institute for Clinical and Translational Research, Former CEO of American Society of Clinical Oncology

 

Dr. Dana Simpler: Primary Care Practitioner, Mercy Medical Center, Baltimore, MD, Has appeared in numerous print and broadcast media, locally, regionally and nationally as a health care thought leader.

And …

 

CME HIV Policy Briefing

 

On September 28, from 12:00 – 1:00 in the Senate Commerce Committee Hearing Room (Russell Senate Office Building Room 253), the Coalition will be presenting a program entitled “Continuing Medical Education:  A Focus on HIV Breakthroughs.”  This panel will comprise thought leaders in the fields of CME and HIV treatment, and will include:

Dr. Jonathan Sackier 

Dr. John Bartlett: Professor and Chief of the Division of Infectious Diseases at Johns Hopkins, Internationally renowned authority on AIDS and other infectious diseases and recipient of the prestigious 2005 Maxwell Finland Award for scientific achievement from the National Foundation for Infectious Diseases.

 

Dr. Alan Wasserman: The Eugene Meyer Professor of Medicine and the Chairman of the Department of Medicine at The GWU School of Medicine and Health Sciences, Chairman of the Board of Trustees and President of The George Washington University Medical Faculty Associates.

 

Space is limited, however, so kindly RSVP at by September 16^th to rsvp@cmecoalition.org or call Shea McCarthy at (202) 688-0225.

 

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