Latest Drugwonks' Blog
The spread of fear in advance of an evaluation of measuable and observable events colors health and science policy. It shapes what we fear and how we measure risk. In a perfect world, government agencies would provide a corrective to simply confirming the fear de jour or reinforcing a false narrative and of what causes illness.
Not so.
The article by Trevor Butterworth (see below) demonstrates how a presidential panel to evaluate cancer risks tries to re-direct research away from predicting and controlling cancer through gene-based and individualized treatment to research that reconfirms claims that all cancer flows from "toxins" in the environment include BPA. As Butterworth shows, what we fear is a collective and political choice that can run roughshod over facts.
www.thedaily.com/page/2011/03/21/032111-opinions-column-professors-butterworth-1-2/
The conflict over cancer
The best angle on the disease? Depends on whom you ask
“When I saw this new report,” said Sir Richard Peto, “I thought, ‘Poor President Obama, he deserves better advice.’” Peto is professor of medical statistics and epidemiology at the University of Oxford, and earned his knighthood for, among other achievements, calculating the incidence of cancer. The report in question was provided last April by the President’s Cancer Panel, an advisory body of experts which had concluded that the incidence of cancer caused by exposure to chemicals in the environment had been “grossly underestimated” by none other than Sir Richard Peto.
Even with its terrifying take-home message — a “come-hither” look to journalists if ever there was one — the Cancer Panel report sank faster than the Titanic, largely because the American Cancer Society agreed with Peto and ripped the panel for treating a shopworn hypothesis as a startling new fact. For all the bluster, the president’s would-be counselors couldn’t provide any statistical data to support their claims.
None of this has stopped the current issue of the New England Journal of Medicine from weighing in with a “perspective” piece on the whole affair by David Christiani, M.D., MPH, who holds positions at both Harvard’s School of Public Health (in the environmental health department) and at its medical school. Christiani disagrees with Peto and takes the report very seriously indeed, believing it warrants an entire rethink of America’s cancer prevention strategy, which — bottom line — means we should spend more researching the environmental causes of cancer.
Every dispute about our health is now a game of “Rock ’Em Sock ’Em Professors,” so let’s rate our fighters’ form:
Back in 1971, plain old Richard Peto joined Sir Richard Doll at Britain’s Medical Research Center, one of the world’s pre-eminent independent scientific institutions, where Doll had conclusively demonstrated a link between smoking and lung cancer. Both men went on to set up Oxford University’s Clinical Trials Unit, a research colossus for epidemiology and statistical analysis. In the early 1980s, they calculated the leading causes of avoidable cancers in the United States, estimating that occupational and environmental exposures accounted for just 4 to 6 percent of all cancer cases.
How good was Doll? He contributed a staggering amount to medicine, including fundamental work in assessing the risk from asbestos, radiation, and the benefits of taking aspirin to ward off heart attack.
How good was (and is) Peto? As Doll’s obituary in The British Journal of Cancer noted, “Although recognized as a good statistician himself, he placed great importance on working with the best available in the field.” Eugene Braunwald, Hersey professor of medicine at Harvard, who is widely considered the pre-eminent cardiologist of our time, has described Peto as “the best statistician in the universe.”
The genius of Doll, plus Peto squared to the power of Braunwald, is not a guarantee of truth, of course. But it presents a powerful warrant: The probability that their calculations on environmental cancer are wrong would have to be justified by, at the very least, a comparable deployment of statistical genius.
And this is where the President’s Cancer Panel simply didn’t bother showing up. Far from being “the Mount Everest of the medical mainstream,” as New York Times columnist Nick Kristoff claimed, it appeared to rely on those who peck in the molehills of conspiracy, including Devra Davis, author of “The Secret History of the War on Cancer,” which was pilloried in The Lancet by the director of the International Agency for Cancer Research, Peter Boyle: “with so many important factual inconsistencies in dealing with areas with which I have some familiarity, I start to have concerns about the factual accuracy in the areas I do not know so well.” (The panel, by the way, did not invite anyone from the International Agency on Cancer Research to participate in its meetings.)
It’s hard not to give the two Sir Richards victory by default.
“The particular reasons they gave for dismissing our work were ridiculously incorrect,” said Peto, after I emailed him for his thoughts. “As far as I’m concerned, the only estimates I’d change much from what we wrote 30 years ago is that instead of attributing 30% of 1978 US cancer deaths to smoking, I’d attribute 33% of 2005 US cancer deaths to smoking, I’d approximately double the risk we attributed to ionizing radiation (to reflect the improved understanding of the hazards of domestic exposure to radon … and I’d be even more definite about the importance of chronic infection than we were in 1981.”
By establishing the leading causes of cancer, Doll and Peto have, in effect, guided the world’s research priorities and spending on cancer. It is little wonder, then, that those who want more money to research environmental causes have to contend with the problem that what they do just isn’t very important in the grand scheme of disease priorities. And not being important, at a time of government cutbacks in research, means less money, not more.
Sunshine? More like dense clouds.
HHS/CMS is holding a conference call on the implementation and potential expansion of the Physician Payment Sunshine Provision of the Affordable Care Act, entitled “Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests.” As CMS noted, “It is seeking stakeholder input on a number of topics defined in the statute.” Those include:
- Comments on additional forms and natures of payment and transfer of value to be considered by HHS.
- Accessibility to and usability of the reported data by consumers.
- Mechanisms for accurate, efficient, and cost-effective reporting of data. 
Here are the details for the call:
Date: Thursday, March 24, 2011
Time: 2:00PM - 4:00PM EST
Number:
Conference ID: 51513526
** Capacity is limited so dial in early. You may begin dialing into this forum as early as 1:45PM EST. **
Submit additional thoughts or feedback following the session to an email address established for this purpose: physiciansunshine@cms.hhs.gov.
Be there or be square – as in squarely in the crosshairs of the COI Polloi. (COI = Conflict of Interest).
According to the HHS/CMS announcement, “The Physician Payment Sunshine Act has the potential to bring about a systemic shift in the health care industry, with government taking a larger role in care of patients.”
Just what everyone (and by “everyone,” I mean “the American public”) fears – “government taking a larger role in care of patients.”
If you go back and look at all the rhetoric surrounding this particular piece of legislation, you will not find a call for “government taking a larger role in the care of patients.”
But, per the good folks in the Humphrey Building, this law certainly does have the potential for significant and severe mission creep. And that’s where it’ll be headed unless we all start paying attention.
And the first person to be queried on this is Senator “Sunshine Charles” Grassley. Is this what he intended? Here’s what he said, “"Shedding light on industry payments to physicians would be good for the system. Transparency fosters accountability, and the public has a right to know about financial relationships."
Nothing there about “government taking a larger role in the care of patients.”
Further, since this conference call is being advertised as an “open door,” perhaps it’s time to open the door to a discussion about the incentives physicians get from insurance companies to switch patients from brand name to generic medicines, or from trial lawyers to be expert witnesses?
If physicians and academicians are paid by industry for their medical expertise – and those payments are important to disclose – why aren’t payments for that same expertise important to disclose when they’re being used by insurance companies and lawyers?
When is a conflict not a conflict? The answer, it seems – it when it’s convenient to the Brotherhood of the Conflict of Interest Priesthood, the COI Polloi.
Who’s pure and who isn’t? Here’s the answer – nobody is 100% pure. Not even Ivory Soap is 100% pure – and it floats!
In the February 7, 2009 edition of 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. Dangerous, because all three constituencies are working towards the same goal -- improved patient outcomes.
His main 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.
The thought of expanding the Sunshine Act to faciliate "government taking a larger role in the care of patients" is an unsunny proposition indeed.
Not to mention an inappropriate one.
At the same time, the number of people being diagnosed and treated for such illnesses as diabetes, cancer, heart disease, respiratory conditions increased. All this has happened even as the number of people without health insurance has declined
The math is simple. More diagnosis and treatment -- largely medicines -- leads to less death and increased life expectancy.
There are some disturbing exceptions. The number of people dying from Alzheimer's continues to climb. The death rate for male African Americans between the ages of 30-45 actually rose. And the number of suicides and the suicide rate among teens increased, even as the rate of diagnosis remained the same.
The difference? Anti-depressant use among male teens declined. Medication use among African-american males between the ages of 18-44 has hardly budged from 1988-2008.
Better health depends on increasing the number of people diagnosed with illness who take medications regularly.
---FOR IMMEDIATE RELEASE---
What if . . .
Iron Lung Foundation Launches "Just Say No To Vaccines" Campaign
New PSA Communicates "Let Nature Take Its Course" Message
NEW YORK (March 17) -- The Iron Lung Foundation is encouraging parents to "Just Say No To Vaccines" with a PSA launched on its YouTube channel.
"Parents should know they are not alone in not immunizing their kids against measles, whooping cough, polio and other illnesses and that living a natural lifestyle in the long run is the best way to keep children healthy," said Eleanor Delano, the Foundation's director of new media.
The PSA features a Manhattan mom with her proudly unimmunized child sitting on her lap . . . with a cough strangely reminiscent of whooping cough.
According to Ms. Delano, "Everyone can see that the child has pertussis and the sky didn't fall. We produced this PSA to show everyone that 'natural' immunity to infectious disease is nature's way. It's part of living a life in harmony with the planet."
To view the Iron Lung Foundation's new PSA, click here:
http://www.youtube.com/watch?v=73oCFzZr8Tg.
###
But honestly -- for more information on the danger of denying the safety and value of vaccines, please contact the Center for Medicine in the Public Interest (www.cmpi.org). President Peter Pitts can be reached at peter.pitts@cmpi.org or (212) 417-9169. Vice President Bob Goldberg can be reached at robert.goldberg@cmpi.org or (212) 417-9169.
BioCentury reports:
Part D negotiation bill introduced
Here we go again.
Remember black and white television? Remember when “cable” meant “telegram” and “fax” meant the opposite of “fiction?” Remember when watching a Fox network might get you slapped in polite company and you wore white gloves to a tea party?
“Back in the day” (as my wonderful children would say), “earned media” meant ink (as in “coverage”). And success was measured by “impressions.”
Today, “earned” means “trusted.” And it’s complicated.
In the good old days there were three ways to communicate a brand message: (1) Bought (as in purchased advertising in its various and sundry forms), (2) Owned (annual reports, brochures, sales materials, inter-office communications, etc.), and Earned (that traditional deliverable of the public relations professional), largely done by talking with journalists, by “pitching” them on a story.
Today, bought still means bought. Owned still means owned. But earned means something different. Today “earned” must be considered largely in the context of interactive, real time, opinionated, snarky, and hugely influential social media.
Today earned media is only partially about attracting the attention of the Fifth Estate and mustn’t be primarily measured by “gross impressions.” Today the “New Earned” is measured by its utility for and impact on multiple levels of influencers. Much more difficult to achieve and measure but, when done right, with far more important implications.
And the only way to engage with influencers credibly is to have something interesting to say that adds to their body of knowledge. Contact for the sake of "face time" is deleterious as it defines you as unimportant. Impact with influencers happens when what you have to share is to their benefit -- not yours. And that requires a level of focus, acumen and honesty that is always hard and often lacking.
That denizen of Twitter, Ashton Kutcher, opined that, “Social media is for entertaining. So be entertaining.” While this may be true in his demimonde, the truth is different for health care where the rule of thumb should be that “Social media is for educating. So become a trusted source.
How? Add value. Participate in social media to achieve marketing goals? Sure. But primarily to advance the public health. Or don't bother. The "New Earned" presents regulated industry with a powerful (albeit uncomfortable) opportunity to be First Among Equals. But that position must be, well, earned through active, lively and regular participation.
How to corral and conquer the New Earned? Become a 21st century NEJM -- The New Earned Journal of Medicine. Or find yourself a cozy little corner on the communications dust heap of history.
America’s biopharmaceutical research companies invested a record $67.4 billion last year in the research and development of new medicines and vaccines – an increase of $1.5 billion from 2009, according to analyses by the PhRMA and Burrill & Company.
PhRMA member companies alone spent an estimated $49.4 billion on biopharmaceutical R&D last year, a 6.5 percent increase over 2009, according to the PhRMA survey. The Burrill & Company analysis shows that additional biopharmaceutical research companies in the United States spent an estimated $18.0 billion on R&D in 2009.
More than 75 percent of research dollars were invested in the U.S.
Over the past decade, biopharmaceutical companies have consistently invested around 19 percent of domestic sales on R&D activities; in 2010, that figure jumped to 20.5 percent.
While many often disagree with Jeff Shuren, those of us who know him and have served with him know him as an honorable man and a dedicated public servant.
Using words like “perjury” to advance an agenda (even, in this case, one that I mostly support) is inappropriate. Intelligent people can (indeed must!) regularly disagree on many things. That's how progress is made.
As background, some reportage courtesy of the talented Matt Herper at Forbes.
FDA Says Official Did Not Lie Under Oath
Jeffrey Shuren, now the head of the FDA’s Center for Devices and Radiological Health, was asked at a Congressional hearing last July if direct-to-consumer genetics companies like 23andMe and DeCodeMe add to the medical literature by doing their own research. He said no.
“From the information we know,” Shuren said, “they are not doing their own research on the genetic profiles but they’re interpreting the studies that have been performed by others.”
FDA critics pointed out that Shuren had just days before those comments listened to a presentation by 23andMe founder and chief executive Anne Wojcicki during which she presented her company’s plans to do research in areas including Parkinson’s. On March 8, Michael Lee, whose FDABlog advocates less regulation for genetic tests, posted a video pairing Shuren’s comments with Wojcicki’s, and saying that Shuren was being “accused of misleading Congress.” That video is embedded below.
The charge was picked up by researcher-blogger Dan MacArthur at Wired and Duke professor and author Misha Angrist. John Derbyshire, writing for National Review, wrote that Shuren “went for Olympic Gold in bare-faced dishonesty.”Razib Khan at Discover viewed Shuren’s comments as a threat to people’s right to view their own DNA. “If they take our rights away because we’re silent, we have only ourselves to blame,” Khan wrote.
But the FDA says Shuren’s comments were accurate because the research 23andMe published was not medical, but instead related to physical traits like eye color and hair color. (23andMe’s paper is here.)
An FDA spokeswoman writes, “We stand behind the comments made by Dr. Shuren,” She adds: “At that time we were not aware of any of the more than a dozen DTC genetic tests making medical claims that were based on results of a company’s own research. Instead, the companies relied on published research in the literature.” (The full FDA statement is below.)
This statement is true. 23andMe has said it is working on using its data, collected from patient volunteers and customers, to try and understand genetic variants that are linked to disease. One area of interest is Parkinson’s disease; Wojcicki’s husband, Google co-founder Sergey Brin, watched his mother suffer from Parkinson’s and carries a gene that may raise his risk of developing the disease.
In context, Shuren’s quote was clearly about medical research, but he should have made the statement in the past tense. The fact of the matter is the anger about his statement is driven by a larger conflict: the collision between a community of genetics researchers and consumers who see access to one’s own DNA as a fundamental right and the medical community, which sees the tests as medical interventions with risks and benefits.
The main fear of those involved with DNA research is that the FDA will create regulations that prevent people from getting DNA test results without a prescription. There are many arguments that this should not happen. Research shows that people can handle the results from these tests, and it’s not clear that doctors are any more ready to understand them than consumers. Right now, these tests provide only limited information, but the technology for understanding human genetics is advancing at a breakneck pace.
My take remains that we’re set up for a huge clash between traditional medicine and genetics as these two fields, which don’t know how to talk to each other, wind up having to work together more and more often. This spat is merely a prelude.
One piece of advice from those angered by Shuren’s comments is very good: it is past time for those who believe it is important for consumers to be able to access genetic data make their views known to Congress and to the FDA.
The full FDA statement:
The FDA is responsible for reviewing clinical genetic tests. To date, direct-to-consumer genetic tests have not been reviewed by the FDA and as a result, we cannot verify that they provide safe and accurate results. The FDA just concluded an advisory panel with experts representing various aspects of the testing community, which provided us with a set of opinions on several scientific issues in DTC testing. We will review these and other public comments in the weeks ahead to determine what we think is the best path forward for addressing the complex issues related to direct-to-consumer testing products.
We stand behind comments made by Dr. Shuren in a July 2010 Congressional hearing on a GAO investigation into DTC genetic tests made by several companies. At that time we were not aware of any of the more than a dozen DTC genetic tests making medical claims that were based on results of a company’s own research. Instead, the companies relied on published research in the literature.
At a separate 2-day public meeting on laboratory developed tests held by the FDA in 2010, a panel of experts and agency officials, including Dr. Shuren, listened to a brief presentation from 23andMe CEO Ann Wojcicki about her company’s early research efforts. However, most of the described activities, including the one paper they had published, pertained to non-medical claims, such as eye or hair color.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
