Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh
Showing posts with label Selling Sickness. Show all posts
Showing posts with label Selling Sickness. Show all posts

Thursday, July 18, 2013

w00t! National Physicians Alliance October 19 & 20 in DC




2013 National Conference  FiDA highlight

MARK YOUR CALENDARS for the NPA 8th Annual Conference, Washington DC — OCT 19 & 20, 2013

“Leading the Way:  Courage & Innovation in Patient-Centered Reform

Plan to join NPA Members and friends from across the country in Washington DC to share energy, inspiration, and knowledge!

Keynote Address
Courage from the House of Medicine

Otis Webb Brawley, MD, Chief Medical Officer and Executive Vice President of the American Cancer Society

National Grand Rounds
Challenging the Selling of Sickness:
A partnership model for a new social health movement

Leonore Tiefer, PhD, clinical psychologist and author of Sex is Not a Natural Act (Boulder: Westview Press, 2nd edition, 2004)
and Kim Witczak, marketing consultant and patient advocate who became involved in pharmaceutical drug safety issues after the 2003 death of her husband as a result of an undisclosed drug side effect.  In 2008 she was appointed to the FDA’s Psychopharmacologic Drugs Advisory Committee as a Patient Representative.

2 special training sessions
with one of DC’s premier media teams:
KNP Communications

The Art of Persuasion
This core training has been provided to hundreds of Senators, Congressional Representatives, CEOs, and leaders of nonprofit and government organizations.
This session covers:
  • strategies for connecting with various audiences
  • an interactive overview of nonverbal cues
  • the uses of story
  • techniques for compelling Q+A sessions

Effective Messaging for Preventing Gun Violence

This training will cover messaging guidance on gun violence prevention that has helped to frame the public debate on this issue since the Newtown tragedy.  Key themes include:
  • the personal toll of gun violence
  • the right to be free from violence in our daily lives
  • the changing nature of military-style weapons
  • and effective responses to common attacks on issues such as the 2nd Amendment

Additional sessions will include:

  • Quality, Affordable, High Value Care Systems
  • Policy Making in Federal Agencies
  • Choosing Wisely:  Making It Happen
  • Skill building sessions:  How to do a radio interview and a Hill visit
  • Innovators’ Forum – a place to share your ideas
  • And more… Reserve your seat today!

–>REGISTER HERE!<–

Plan to join us in Washington DC, October 19-21, 2013

Stay over Monday, Oct 21, to join NPA members on Capitol Hill
and meet with your congressional representatives.

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Conference Location

A Facility Owned and Managed by the American College of Surgeons
20 F Street, NW (near Union Station), Washington, DC,  20001
Directions -  Area Map

Hotel & Travel

NPA has reserved a limited number of hotel rooms at a special conference rate of $169/night plus tax at the Washington Court Hotel525 New Jersey Avenue NW, Washington DC 20001 (near Union Station)
Reservations must be made directly with  the hotel at
(202) 628.2100 or (800) 321.3010

*Be sure to specify that you are reserving as part of the National Physicians Alliance group.

Deadline for reservations at the conference rate is
Friday, September 20
.

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Submit a Poster!

Are you doing exciting new research, implementing quality improvement, building a local network, or advocating for an important issue in your state or nationally?  Your NPA colleagues want to learn about it!  Submit your work to our 2nd annual poster presentation at the NPA 8th Annual Meeting, October 19-20, 2013 in Washington DC.  Click here for details.
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Contact Becky Martin, NPA Project Manager, if you have questions or need additional assistance, becky.martin@npalliance.net or call 202/420-7896

Monday, March 18, 2013

Mayo Clinic: Selling Sickness or Reform Leadership?


                Article by: PAUL JOHN SCOTT  , Star Tribune Updated: March 16, 2013 - 7:50 PM
The question about Mayo’s plan for a Destination Medical Center isn’t whether it makes sense for Rochester and for the state. (It does.) The question is whether Mayo will seize this moment to lead change in an industry gone awry.
Rochester – At the forum a couple weeks ago to discuss the big news, they did not plan for the mad crush of bodies. They booked a too-small room, and the mob spilled out the door. Open meetings around here are usually a snore, but the surprise announcement of the Mayo Clinic’s plan for a Destination Medical Center drew the largest crowd to ever show up for one of these things. Judging by some of the faces, the proposal is especially inviting to the city’s growing corps of creatives, culture mavens, biotech wonks, coastal transplants and TED Talk fans. We in Rochester know this is a critical moment that may not come our way again, and it feels close. Nearly everyone in the room wanted this thing to happen.
Chances are the Legislature is going to come around to the DMC idea as well — if not for its merits, simply because of the way privately funded construction budgets with a B in them have a way of focusing lawmakers’ minds. The numbers are unprecedented: The plan promises $3.5 billion in local capital investments by Mayo over the next 20 years. It promises $2 billion in Mayo-leveraged private investment in urban living, entertainment, dining, arts and cultural amenities. It promises 30,000 new jobs. The catch: When new tax revenues from this expansion are produced, it asks for 10 percent of those funds, roughly $585 million over 20 years, for roads, sidewalks, parking, transit and sewers needed to support the new buildings.
So it’s not a handout, not by any stretch. Mayo is planning on growing faster than the tax base can keep up, and has figured out a novel way to get around the problem. The financial model is a first in the nation.
What’s not to like? Critics have objected to diverting any revenues, even hypothetical ones, toward a prosperous city when state revenues are scarce as it is. They object to the granting of special treatment to one employer over others, even if that firm plays an outsize role in the state economy. (With 30,000 employees, Mayo is the largest private employer in the state.)
Others see trouble ahead, given the likelihood of the need for eminent domain or the forced sale of private property through court-appointed means. (To be honest, a lot of buildings in this town make a good case for eminent domain.) One could also ask why the state should subsidize Rochester’s new plazas in exchange for new Mayo expansion when the clinic was on track to spend $5 billion over the next 20 years anyway, given its current spending patterns.
This presumes a bit. Mayo could always build elsewhere (even if last month there were four tower cranes over its two Rochester campuses). The complaint expressed by House Tax Committee chair Rep. Ann Lenczewski that the project is a “massive public subsidy” that will somehow cause “a tax increase for everyone else” is consistent with her view on projects like this in the past. But it doesn’t track with the reality of the bill.
The state loses no money; it only gets less new money. She is essentially complaining about getting a little bit less of funds the state was never going to get in the first place.
Now there’s an argument to make a Democrat wince.
These criticisms may sound high-minded, but there is a football stadium ready to break ground that suggests any pushback to Mayo DMC has less to do with the sanctity of the public purse than with residual regional rivalries too tedious to mention. In other words, if you support the state of medical practice today, it’s a no-brainer to support Mayo DMC. And I don’t say that just because I want more public sculpture at the base of my street.
But the moment bears mention for reasons other than Rochester’s options when it comes to sushi. Mayo says it is asking for this partnership in order to retain its position in an evolving health care marketplace. The clinic says there are 13,000 people coming into Medicare coverage every day, 30 million new enrollees in private insurance next year, and a future in which a small handful of global brands will serve patients who travel to destination cities for their health care. It has watched competitors in Baltimore, Houston and Cleveland engage in an arms race to attract these patients, and is determined to ensure its place on that list.
At the recent meeting, a Mayo spokesperson could not spell out the precise use of the $3.5 billion in new buildings the clinic plans to create — she only knew that more buildings will need to be built. So this seems less like a need in front of Mayo officials than like a strategic decision to stay in front by staying big.
Going big may make sense in a rational marketplace, but medicine is no rational marketplace. We’re not talking here about the usual problems one associates with health care — the lack of transparency in pricing, the lack of negotiated drug buying power in the government, and the problems with fee-for-service medicine. Those are all drags on the system, but they miss a deeper issue.
The market Mayo now seeks to dominate is that of serving sick people, and if one is honest about it, these are strange times to be fighting for market share of sick people. The reason: We have witnessed a near complete takeover of medicine by private industry. The product of this takeover — let’s call it the medical-industrial complex — has shown that if its market is sick people, it will not hesitate to create new customers.
How does the medical-industrial complex create new sick people? Not by making people sick — not intentionally, anyway. It markets sickness. It lowers the threshold for being diagnosed with an illness.
It broadens the symptom profile of an illness. It encourages doctors to treat symptoms as one would an illness that meets the formal criteria of diagnosis. It develops tests that trigger unnecessary procedures. It funds patient advocacy groups to “raise awareness” about the need for ineffective screening methods and expensive treatments. It funds medical societies, medical journals, clinical trials, the FDA, individual doctors, health systems, magazine ads, television spots, social-media campaigns and political campaigns in both parties, and it feeds illness-pushing stories to overworked health reporters.
I know, because I have written a few of them myself.
Private interests have merged with the very organizations Mayo finds in its path to customers. The massive Cleveland Clinic complex that has placed Mayo on its heels — it was going to be called a “Medical Mart” until someone thought better of it — includes a facility built by GE Heathcare, makers of our ubiquitous screening technologies. But as Peter Gotzsche of the Nordic Cochrane Center has demonstrated, 80 percent of Denmark has gone without mammograms for decades, while 20 percent of the country has been screened regularly. This “makes for the perfect control group,” he says, and when you compare the Danes who had mammograms with those who did not, there is no difference in mortality. Both groups experienced a drop in mortality around the introduction of drugs like Tamoxifen, yet mammograms got all the credit. This is comparable to the way in which device makers have taken credit for a drop in heart disease mortality during a period in which millions of Americans quit smoking.
You don’t need to visit a specialist — you can see the takeover of medicine during an hour in the office of your primary care provider.
The creation of clinical practice guidelines, directives conceived by doctors being paid by industry, has turned family medicine away from listening to the experiences of patients and toward the monitoring of blood markers denoting overblown risk factors for disease, surrogates for illness that can then be controlled by expensive drugs. Some of the most widely used drug treatments today serve the needs of the drug industry, not patients. They lower cholesterol or blood sugar without reducing the incidence of disease, and yet they are the sort of reasons we are so often told to “Know Your Numbers.”
We cannot count on the medical literature to clear up the problem.
Years of abuse have made it a repository of spin. Clinical trials that used statistical slight of hand to make failed trials look successful (see “Bad Pharma,” by Ben Goldacre). Review articles on new drugs or illnesses written by drug industry ghostwriters, signed for pay by influential doctors, then placed by professional publication planning agencies into credulous journals in exchange for hefty reprint orders. Industry-funded clinical trials of new drugs in which doctors never saw patient reports, only summaries of data they were asked to trust.
And as government lawyers given access to industry e-mails have learned, if a study still somehow failed to show that a new drug is safe or indeed works, it was often either shelved, or intentionally published in academic Siberia. In its own journal, Mayo Clinic Proceedings, Mayo recently published a proposed reform of these practices, but it was written by representatives from the very ghostwriting and drug companies that created the problem.
Disclosure of doctors’ conflicts was supposed to reform the system, but since the new disclosure rules, something funny has happened: Within medicine, long lists of side money have become a badge of honor.
As health policy expert Rosemary Gibson argued last month at “Selling Sickness: People before Profits,” a global meeting organized by Minneapolis health activist Kim Witczak, the problems in medicine today share disturbing similarities with banking. Too big to fail. Inflated salaries. Toxic assets, price bubbles, sophisticated products marketed to unsophisticated buyers and subsidized profits followed by socialized losses.
The Mayo Clinic did surely not create this environment, and when it comes to steering clear of unnecessary treatments and resisting the influence of industry, it does many things better than most. But Mayo is about to take a bold step forward within a system that has lost its moorings.
Let’s hope that as it does so, it seeks a way to reform, rather than simply prevail.
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Paul John Scott is a writer in Rochester.

Thursday, November 15, 2012

Selling Sickness: People Before Profits


http://sellingsickness.com/medical-devices-under-scrutiny/


February 20-22, 2013
  
register today!
Hyatt Regency Washington on Capitol Hill
 
Washington D.C.

MEDICAL DEVICES UNDER SCRUTINY
Overtreatment, over-marketing, conflicts-of-interest and all the trappings of disease-mongering pertain not just to medical treatments, education, publishing, screening and drugs, but, increasingly, to medical devices, both the kind that are used IN the body and ON the body. It is clear from current scandals and investigations in the US and UK that the device approval and oversight systems are, according to the BMJ, “fragmented, poorly regulated [and] market driven,” and that, shockingly, “financial incentives prioritize manufacturers’ interests over those of patients, with no requirement for clinical evaluation of a devices’ safety or effectiveness.”
Digging into the background of medical devices is eye-opening for someone already familiar with medicines and their scientific and regulatory problems. It’s a whole new world of engineering and chemistry, radiation and plastics, chips and tags, etc.
What isn’t new is the revelation of a patchwork and antiquated approval and regulatory system based on levels of risk that seems more appropriate to tongue depressors than hip implants. We’ll be sure to take a look at this topic next February at “Selling Sickness, 2013.”

Wednesday, July 11, 2012

Selling Sickness 2013 - People Before Profits

LINK
February 20-22, 2012 at the Hyatt Regency on Capitol Hill, Washington, DC
http://sellingsickness.com/
 2006 Inaugural Congress on Disease Mongering in Australia  marked a watershed in networking among health care reformers and drug industry critics.
 2010 Selling Sickness conference in Amsterdam expanded the network and updated the work.
About
Selling Sickness 2013 will bring together academic scholars, healthcare reformers, consumer advocates and progressive health journalists to examine the global tide of disease mongering.
Conference will include topics pertaining to disease-mongering such as: misleading marketing; ethics in professional education; journalistic standards; social media; over-treatment; new models for drug development and testing; whistleblowers; new conflict of interest areas; health screening policies; impact on public health and pocketbook.
The conference is designed to encourage audience participation and increase collaboration among the conference attendees.
Kim Witczak 


Kim Witczak became involved in pharmaceutical drug safety issues after the death of her husband, Tim “Woody” Witczak in 2003 as a result of an undisclosed drug side effect. She has taken her personal experience and turned it into advocacy/public awareness campaign on drug safety which included the SSRI/suicide risk (which resulted in black box warnings being added to antidepressants), DTC advertising, undue Pharma influence, COI, PDUFA, and FDA reform. Kim has testified before US Senate on PDUFA/FDA reform as well as numerous FDA Advisory Committees. In 2008 she was appointed to the FDA’s Psychopharmacologic Drugs Advisory Committee as a Patient Representative. In 2004, Kim launched www.woodymatters.com in memory of Woody’s life and death as a resource for others that live every day with the consequences of a flawed drug safety system.