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

Tuesday, April 2, 2013

Replaced hips/knees: half may not help pain/function.



Joint pain, function not always better after surgery

March 27, 2013 3:43 pm by  | 0 Comments
NEW YORK (Reuters Health) - Only about half of people who have a knee or hip replaced see meaningful improvements in pain and disability in the months after surgery, a new study from Canada suggests.
Researchers found people who had worse knee or hip pain to begin with, fewer general health problems and no arthritis outside of the replaced joint were more likely to report benefits.
"I think this study really represents the general picture that often people do not have arthritis in just one joint," said Elena Losina, an orthopedic surgery and arthritis researcher from Brigham and Women's Hospital in Boston.
"It's of course good to set expectations appropriately that if you have three joints affected, doing one procedure is not going to be a miracle," said Losina, who co-wrote a commentary published with the new study.
More than one million people in the U.S. have a knee or hip replaced each year, researchers said - a rate that's expected to continue to grow.
Including hospital fees and the parts themselves, the procedures cost $20,000 to $25,000 and are typically covered by insurance.
Despite the rising popularity of joint replacement, uncertainty remains about which patients have the most to gain and who fares best post-surgery. So a team led by Dr. Gillian Hawker from the University of Toronto tracked about 2,400 older adults with osteoarthritis or inflammatory arthritis in Ontario, Canada, to see who went on to get surgery and how they did.
From the start of the study in 1996 through early 2011, 479 of them had a knee or hip replaced, including 202 who underwent elective surgery and had before and after pain and disability information available for analysis.
Most surgery patients were women with pain in more than one joint, and over 80 percent were overweight or obese.
By a year or two after surgery, the average person had a 10-point improvement in pain and disability from a pre-surgery score of 46.5 out of 100, the research team wrote in Arthritis and Rheumatism.
A nine-point improvement is considered the "minimal important difference" in symptoms, and about 54 percent of joint-replacement patients hit that target.
Unlike general health and other joint problems, people's weight did not predict how they did after a knee or hip replacement, Hawker and her colleagues found.
Losina said that even if a first joint replacement leaves people with some pain and disability, it may help them make incremental steps toward better health.
And doctors may need to realize that until some people get each of their painful joints replaced - not just one knee or hip - they're not going to have optimal outcomes, according to Hawker.
"We have to look at the whole patient, not just a single joint," she told Reuters Health.
Researchers said the new findings provide more evidence for patients and their doctors to use while discussing the pros and cons of knee and hip replacement.
"This is not an easy surgery, it's an expensive surgery, and I think people should understand what they are getting into and what are the expected outcomes," Losina told Reuters Health.
Andrew Judge, who has studied joint replacement outcomes at the University of Oxford in the UK, agreed these kinds of findings are important to help inform doctor-patient decision making.
"Further research is required in other large datasets in order to confirm these findings, and to identify other key determinants of good outcomes, to inform the development of a future clinical risk prediction tool," he told Reuters Health in an email.
SOURCE: http://bit.ly/WVTTfx Arthritis and Rheumatism, online March 4, 2013.

Monday, April 1, 2013

Patient Harm: Violence, Betrayal, Trauma



by Olga Pierce
 ProPublica, March 21, 2013, 2:30 p.m.  (FiDA highlight)
                                
“How is it possible to move past medical harm when every single aspect of life is impacted by it – when absolutely everything a person believed about doctors, lawyers, oversight agencies, insurance companies is turned upside down and inside out?” – Robin Karr, patient harm survivor

A slip of the scalpel, an invisible microbe, a minute miscalculation. It's estimated that something goes wrong for more than one million people per year during a visit to the hospital. Some patients experience a full physical recovery. Some are never fully healed.
But even if patients are lucky enough to physically heal, their lives may never be the same. Sleep becomes elusive, relationships break apart, and a wall of silence appears between patients and the doctors they trusted.
What follows is a conversation of sorts between some of the 1,550 members of our ProPublica Patient Harm Facebook community and Dr. Gerald Monk, a professor at San Diego State University who specializes in dealing with the aftermath of patient harm for both patients and providers. We asked group members to share their questions and thoughts about the aftermath of patient harm, and then got Monk’s response. What emerges is a portrait of the long journey that begins after the unthinkable happens.
(Monk’s comments are not a substitute for treatment by a mental health professional. They have been edited for clarity and length. Each quote in italics comes from a member of ProPublica’s Patient Harm Facebook group.)

PP: What symptoms can survivors of patient harm expect?

“I find I think about what happened day and night.” –  KariAnn Syna 
“Survivors have “very real PTSD symptoms, including avoidance, difficulty sleeping, etc.” – Debra Van Putten
“I experience ‘flashbacks.’” – Georjean Parrish
Dr. Monk: The psychological symptoms are similar to those people suffer when exposed to physical, sexual and psychological violence. What all these things have in common is that they take place in settings where we reasonably anticipate that we will be safe and secure. We tend to believe the maxim that the doctor will do no harm.
The symptoms can be physical, such as headaches and sleeplessness; or psychological, like depression, anger, guilt and being vulnerable to drug abuse.  Patients can even blame themselves. A survivor of harm surely knows others that have had the same medical procedure without suffering harm, and so they can feel they somehow contributed to the error because they were at the wrong place at the wrong time with the wrong health care provider.

PP: Many group members expressed feelings of betrayal by the health professionals and authorities they thought were there to protect them. What phenomenon are they experiencing?
 “A patient who is denied validation for their medical injury is betrayed by the medical system they have learned to trust as an official authority. It is a shocking experience to realize that everyone one has thought about trusting this authority is suddenly wrong.” – Garrick Sitongia
Dr. Monk: Patients can feel especially violated in the context of health care. Not only do patients anticipate being safe and secure, they expect to be healed. Following an adverse medical event, a patient may experience a lifetime of heartbreaking anguish and suffering.

PP: Group members describe a related problem. Others are reluctant to hear their new understanding of the health care system and dismiss them as crazy or tell them “it’s all in your mind.”
Dr. Monk: Doctors are trained to be perfectionists. They are expected to answer difficult heath care problems and to know how to heal. Sometimes doctors are also pressured to gain legitimacy by exuding a sense of confidence and certainty when they don’t actually know how to make a patient well.
As we know, the reality is that health care is far from perfect. Medicine is inexact yet doctors face the expectation that they will fully understand the human condition and know all of the complexities about what ails us.
This is an onerous responsibility, and this territory can be ripe for misunderstanding between health care providers and the patient and family members. Doctors may feel that patients haven’t communicated all of their symptoms or followed through on their instructions, and this can leave patients and their families feeling blamed.

PP: Many patients say they encounter a ‘wall of silence,’ where providers are unwilling to discuss what happened and which hinders the healing process.

"There can be a “refusal of anyone to talk about the emotional impact or an error on both the provider, care team, patient, and their family ... it feels like a systems error ends up being an individual problem and no one wins.” – Sherry Reynolds 
Dr. Monk: The health care environment is still dominated by the culture of “deny and defend.” Most physicians have been trained not to apologize when things go wrong and warned by their mentors that it can lead to a lawsuit. Actually, the opposite is true. Harmed patients who do not receive an apology and an open and transparent investigation about what went wrong are often left with a strong desire for justice. These feelings of injustice drive them toward a lawsuit. 
But legal action can make things worse for the patient. It seldom produces any sense of justice and healing and often leads to even more trauma. In contrast, an open and heartfelt acknowledgment of an actual or perceived medical error could lead to psychological healing.
Another distressing part of this “deny and defend” culture is that many doctors and nurses actually want to apologize when things have gone wrong. Many providers went into medicine because they want to be healers and bring good to people’s lives. When things go wrong, it can have catastrophic consequences for providers. They often suffer what is called ‘second survivor’ syndrome. They are traumatized by causing the patient harm and they are isolated and trapped with secret knowledge about what really happened.

Providers are often called the “second victim” in cases of patient harm, and struggle to handle deep feelings of guilt and remorse.
Fortunately, a growing trend is changing the culture of deny and defend. For example, large health care systems within California, Illinois, Maryland, Missouri, Massachusetts, and Virginia are trying to overcome the barriers in the health care environment to open, honest disclosures and encourage apologies when things go wrong. Some doctors are doing the same: disclosing medical errors and making heartfelt apologies. These conversations can be restorative for providers, patients and their families.
PP: Survivors of harm also describe themselves as isolated from their families just when they need them the most. Sometimes loved ones have trouble coping with the damage, other times they don’t understand why the victim of harm can’t ‘just move on.’
“My husband never doubted me, but the challenges financially, physically and emotionally after suffering irreparable damage by my former dentist … destroyed our happiness ... He and I separated.” – Tina Gomes
 “I have no family now due to what was done to me ... This has proven to be too traumatic for my family to endure so I find myself with no family and no support. It’s as if I’m dead.” – Robin Karr
Dr. Monk: The harmed patient can become frozen with unprocessed emotional trauma following the harm they suffered. They can become stuck in emotional distress and psychological fragility. Loved ones and friends may become exhausted by the victim’s ongoing anguish. They may start to recoil from hearing any more about this ugly situation.
Significant others can feel powerless to do anything other than encourage the harmed party to go to court or stay with a legal process. That can take more than five years, cause significant financial strain, and many cases are decided in favor of the health care professional. This contributes to the paralysis for the family and the harmed patient. These powerful stressors often lead to separation, divorce and alienation of family members.

PP: The feelings of isolation or abandonment are not necessarily limited to friends and family. Many social relationships can be strained, and survivors can feel shunned.
“We went from being the perfect family to being seen as the Addams family. When you have a child die from 100 percent medical error you become every mother’s worst nightmare ... It is a grief and pain most people, fortunately, can never understand and are afraid to come near.” - Lenore Alexander
Dr. Monk: There are no societal rituals about how to grieve the losses that come from serious medical error in a socially acceptable way.
While people can be kind and compassionate in their efforts to help, eventually there may be a growing sense that ‘enough is enough’ and survivors need to put this behind them and move on with their lives.
When family and friends tell the survivor of patient harm to move on, or suggest they are psychologically unwell, this can add feelings of shame and guilt to the grief they already feel, which may actually make the healing process longer.

PP: In addition to emotional trauma, there may also be lasting health effects that drag on for years or even permanently.

“How do you ever move on, when you live in a damaged body that reminds you every minute of every day what you lived through?” - Georjean Parrish
“I try to cover up my now ugly body with nice clothes...my body looks deformed.” - KariAnn Syna
Dr. Monk: For a few people there is a form of loss and grief caused by a grievous physical injury that seems to take over a person’s whole being. Physical prowess and attractiveness can be an important part of how people define themselves. Day-to-day physical injuries and impairments caused by a medical error remind victims of what they no longer have in strength, mobility, being pain free and physical appearance.
Some survivors know their body has been harmed forever but they still can’t believe it. Time is moving along but they are not. Yearning for the life they had before the trauma, thoughts and images of the person they once were frequently fill their mind.

PP: Some survivors find the struggle to find acceptance or forgiveness an impediment to moving on with their lives.
“It took until I was finally diagnosed and two surgeries later to even begin to be able to ‘let go’ and ‘forgive.’ After I got Medicare and could go to doctors ... who listened and understood, I could begin to be grateful and that’s when healing starts.” - Anna Gardiner
“A big problem is one of acceptance.” How do harmed patients separate accepting their damaged selves from feeling like they are saying that what happened to them was acceptable?” - Jeri Tresler
Dr. Monk: The desire for revenge can be a common reaction among patients who have survived a terrible medical error or for families who have had a loved one die because of a medical mistake. This is compounded when the expected legal punishment falls far short of expectations.
Survivors of serious medical error can feel shocked and horrified by the intensity of their own vengeful impulses when they have recovered sufficiently to have those feelings. They may even withdraw from community support because they feel ashamed of wanting revenge.
In many Western cultures, the desire for vengeance is taboo, and society instead pressures victims of harm to ‘turn the other cheek’ and forgive the perpetrator. But misplaced efforts to encourage forgiveness before the victim is ready can just cause more shame and distress.
Victims of an error need somebody who can acknowledge, accept and support them around intense displays of emotion and not withdraw from them but rather step toward them.  Harmed patients at this time can benefit from working with a counselor who is not frightened by powerful feelings of rage, and revenge.
Counselors trained in dealing with trauma can help survivors speak openly about their experiences without being brushed aside or have the topic changed. This helps a harmed patient begin their own emotional repair. An overarching desire for many harmed patients is to want to move beyond the terrible emotional scars that may accompany the physical ones. Physical injuries may never be healed. Thankfully, with qualified help, emotional injuries can be.
Illustrations by Marina Luz
Exploring Patient Harm: Have you been affected by patient harm? Join our Patient Harm Community on Facebook to share your experience with patients, family members and others affected, or tell our reporters your story by completing our patient safety survey.

Friday, March 29, 2013

Gummy Bear Breast Implants




February 22, 2013 Written by Diana Zuckerman  FiDA highlight
Do you like your body?   If there was a simple way to change it, with no risks, would you do it?
If making that change meant you would put your health at risk and have multiple surgeries for the rest of your life, would you hesitate?
Most women say they don’t like their bodies, and research shows that dissatisfaction usually starts during the middle school years and may never go away.  For many of us, it eases up a little in young adulthood as we come to appreciate our attributes and accept any “flaws,” but insecurities rev up again as aging takes its toll.  It seems ironic that we long to regain the body that seemed so imperfect when we were younger.
In the U.S., there are thousands of products and procedures that feed on women’s insecuritiesMost are ineffective – the pills and products that promise to melt fat away without diet or exercise, or to make cellulite or wrinkles disappear.  But only a few are actually dangerous to our healthBreast implants are one of those.
The FDA just approved a new kind of breast implant, which many plastic surgeons promise will be safer and better than other kinds of breast implants.  It is made of thick silicone gel (nicknamed “gummy bear implants” for its consistency), which is supposed to prevent it from breaking, leaking, or wrecking havoc with your body.
What’s the proof that this product is safer, or even safe at all?  Apparently, that’s a secret.
When breast implants were first sold in the U.S. in the 1960s, no testing was required to make sure they were safe.  For the next 30 years, more than a million women in the U.S. got breast implants, not realizing that studies on women had never been done to prove they were safe or to determine how many months or years they would last.
In 1990, I was working as an investigator in the U.S. House of Representatives when a Senate staffer called me.  She told me that her mom had gotten breast implants after a mastectomy, which had resulted in terrible problems including silicone leaking out of her nipples.  Her mom was cured of cancer but the implants had put her through hell.  I was sure that the FDA had very strict rules about safety testing, but I promised I’d look into it.
I found out that I was wrong: the FDA had never required clinical trials for breast implants.  We held a Congressional hearing, I continued my investigation, and soon my office – and the media – was full of horror stories about women whose health had been ruined by breast implants.
Thanks to Congressional and media pressure, the FDA changed their policies.  They eventually required breast implant companies to conduct studies on hundreds of women with breast implants, to find out how safe their products were.  Public meetings were held so that women could testify about their experiences, scientists could openly discuss the research, and the media could report what was said.  Some companies failed to do the newly required research and their implants were no longer allowed to be sold in the U.S.  And, although all breast implants were found to have high complication rates, the FDA, under tremendous pressure from implant companies and plastic surgeons, decided that women were capable of making an informed choice about the risks they were willing to take.
I have no doubt that women are capable of making an informed choice.  But the FDA is still not providing the full information that women need to make an informed choice, and neither are the plastic surgeons.
In a giant step backwards, some FDA officials are reverting to their old ways.  They approved “gummy bear” implants with no public meeting and they have not made the study findings public.  Instead, in a press release that the agency quietly released on February 20, they report that the new breast implants have the same kind of complications as other types of implants – such as hard, painful, or lopsided breasts and the need for additional surgery – but don’t say how often those complications occur.  They also reported a new complication: the silicone gel in these new implants can crack.  What happens to women when that happens?  The FDA isn’t saying.
Since I did my investigation in 1990, I have been one of the FDA’s strongest critics and biggest fans.  I have often been horrified by some of the decisions FDA makes to approve unsafe or inadequately tested medical products, but I also know that when the FDA does its job well, it can save millions of lives.
When I did the Congressional hearing on breast implants, I was 7 months pregnant.  My son is now a college senior.  In those 22 years, the FDA regained and is now again at risk of weakening its public health focus, as Congressional pressure on the FDA to protect patients has been replaced by Congressional pressure to get products to market as quickly as possible and thus “create jobs.”  Whether it is breast implants, riskier birth control pills, TB drugs that do more harm than good, or sleeping pills with questionable benefits, the FDA is allowing drugs to be sold that do a lot of harm.  And when the FDA fails to hold medical products to a high standard, it is women – the consumers of most medical products – who are harmed the most.
For more information about the FDA’s recent decision on Allergan breast implants, see Statement of Dr. Diana Zuckerman on FDA approval of new Silicone-Gel Breast Implant Natrelle 410 and for more information about the risks of breast implants, see www.breastimplantinfo.org
Diana Zuckerman is the president of the National Research Center for Women & Families. She received her PhD in psychology from Ohio State University and was a post-doctoral fellow in epidemiology and public health at Yale Medical School.  After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House.  She is the author of five books, several book chapters, and dozens of articles in medical and academic journals, and in newspapers across the country.


Thursday, March 28, 2013

Report doctors with fraudulent medical device investments.

https://oig.hhs.gov/fraud/docs/alertsandbulletins/2013/POD_Special_Fraud_Alert.pdf



The Health and Human Services Inspector General’s office issued a fraud alert Tuesday, warning consumers and medical professionals about physician-owned groups that get kickbacks from medical device companies in exchange for pushing the devices on to patients.
The warning doesn’t name names but says these so-called physician-owned distributorships “produce substantial fraud and abuse risk and pose dangers to patient safety.” In particular, the warning addresses implantable devices used in procedures either at hospitals or ambulatory surgical centers.
Of concern is whether patients get inappropriate medical referrals or recommendations influenced by financial incentives. Such practices violate the Social Security Act, which prohibits doctors to recommend devices for any Medicare or Medicaid program where they would get reimbursed. Further, regulators don’t believe disclosure by the doctor is enough, since it’s often used as an added incentive for patients to use a particular product or facility.
You can read the full warning here.
Follow Russ Britt on Twitter @russbrittmktw
Follow Health Exchange blog on Twitter @MWHealthBlog

Wednesday, March 27, 2013

Patients Deserve to Know: Medical Device Ownership




Posted: March 26, 2013 - 12:30 pm ET      FiDA highlight

Doctors who hold part ownership in medical device companies, beware: people in HHS' inspector general's office are watching you. And they don't like what they see.

The inspector general's office published a special fraud alert Tuesday (PDF) on the rapidly growing phenomenon of physician-owned distributorships, or PODs, saying, “OIG views PODs as inherently suspect under the anti-kickback statute.”

The office is already investigating physicians who hold ownership stakes in spinal-implant businesses, and whether those doctors practice at hospitals whose Medicare patients receive a higher-than-average proportion of spinal-fusion procedures. That case may also widen to include doctors with stakes in cardiac-device makers, the office's 2013 work plan says.

The alert follows a letter from five bipartisan members of the Senate Finance Committee in June 2011 (PDF) that said a Senate investigation had turned up evidence physicians were being pressured into taking on lucrative ownerships in device companies because of a dearth of federal rules on the topic left it open to abuse.

Under federal law, it may be legal for a surgeon to hold shares in a company that manufactures devices that the doctor prescribes for his patients, even if it's a small company that manufactures a product not widely used outside of the hospital where the doctor practices. But such arrangements are risky and easy to abuse, the alert says.

Medicare's Anti Kickback law makes such arrangements illegal if even one of the doctors' motives in prescribing devices he has ownership in is personal profit. Those risks are particularly acute, the alert says, for physicians who own stock in companies that make surgically implanted medical devices, because hospitals typically listen to doctors' preferences when making purchasing decisions about those devices.

In figuring whether a particular arrangement may be illegal, the inspector general considers, among other factors, whether the profits gained from device-maker ownership are out of proportion to a small investment by the doctor; whether the price of the stock varies depending on how much prescribing the doctor is expected to do; and whether doctors have to sell their ownership if they change specialties.

Failing to report an ownership interest is also a red flag, the alert says.

“This is important guidance for providers who legitimately want to avoid getting into difficulty with the federal Anti Kickback law,” said Don White, a spokesman for the inspector general's office.

The senators' 2011 letter said that such specific guidance was needed by physicians who were being encouraged to enter physician-owned distributorships of uncertain legality. The letter cited specific feedback from doctors: “One surgeon who was pushing back against his colleagues pressuring him to join a POD wrote that those colleagues were citing the absence of any prevailing guidance specifically on point on this topic as a reason for joining a POD venture, and that 'this sort of thought is what prevails unless OIG takes a stand.'”

The HHS inspector general's office is slated to release its sweeping investigation of PODs later in 2013, according to the office's work plan.

“Anytime a few bad actors determine the treatment and care of patients, as this warning makes clear, patient safety is put at risk and millions of dollars are lost to fraud. This is simply unacceptable,” said Sen. Orrin Hatch (R-Utah), the ranking Republican on the Senate Finance Committee.

Hatch, who released a critical report on PODs in June 2011, was joined by committee chairman Max Baucus (D-Mont.), who said the alert raised serious questions about the practice.

Patients have a right to know they're getting treatment that's tailored to them – not someone else's bottom line – but physician-owned distributorships may put that guarantee in doubt,” Baucus said in the emailed statement.

Senator Max S. Baucus
202.224.2651
max@baucus.senate.gov
511 Hart Senate Office Bldg
Washington, DC 20510


Monday, March 25, 2013

Invest in Hopeful Documentary on Patient Harm: Breaking the Wall of Silence



1.  Click Here!  Documentary director, Carolyn McCulley from CityGate Films talks about the project


2.  Click Here!  Invest today:  

Kickstarter campaign ends on March 31, 2013


http://www.leanblog.org/2013/03/podcast-168-carolyn-mcculley-breaking-the-wall-of-silence/

 Notes and links:
                The book upon which the title of the film is based (as a homage, not a direct translation of the book into film): Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans
                The book by Dr. Marty Makary she mentions: Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care
                Statistics on patent safety and quality problems
                Past episode with Sorrel King
                Earlier podcast with Clare Crawford-Mason that includes a discussion of her film “Good News…How Hospitals Heal Themselves
                Episode with Dr. Richard Shannon talking about Lean and infection reduction
                The “seven pillars” approach to improving patient safety
For a link to this episode, refer people to www.leanblog.org/168.
For earlier episodes, visit the main Podcast page, which includes information on how to subscribe via RSS or via Apple iTunes.
You can use the player (use the VCR-type controls) at the top of the post to listen to a streaming version of the podcast (or click here for the streaming audio and RSS subscription). The streaming link is faster for one-time listening (hardly any delay to start listening). Or you can use the download link to put it on your iPod or other MP3 player.
A new way to listen to free streaming episodes of the podcast: Download the free Stitcher app and use promo code LEANBLOG for a chance to win $100.
If you have feedback on the podcast, or any questions for me or my guests, you can email me at leanpodcast@gmail.com or you can call and leave a voicemail by calling the “Lean Line” at (817) 776-LEAN (817-776-5326) or contact me via Skype id “mgraban”. Please give your location and your first name. Any comments (email or voicemail) might be used in follow ups to the podcast.


About LeanBlog.org: Mark Graban is a consultant, author, and speaker in the “lean healthcare” methodology. Mark is author of the Shingo Award-winning book Lean Hospitals and Healthcare Kaizen. Learn more about Mark’s on-site and public workshops. He is also the Chief Improvement Officer for KaiNexus

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.