The following is an unofficial transcript of parts of an interview that Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, gave to Ed “Flash” Ferenc, host of the labor-oriented, Cleveland-based America’s Work Force Radio, on Aug. 15, 2014. In addition to the points he makes below, Dr. Nissen also spoke about pharmaceutical drug safety and other issues. The audio of the entire program is available at awfradio.com/todays-show-8-15-14/. The segments of the show that feature Dr. Nissen are noted at the end of the transcript.

HOST ED ‘FLASH’ FERENC: We’re going to start things off with Steve Nissen. Steve is the chairman of cardiovascular medicine at the Cleveland Clinic. He served nine years as vice-chairman, five years as medical director, of the cardiovascular center that directs multi-center clinical trials. He’s got some national leadership positions, too, which include a term as president of the American College of Cardiology. He also served the Food and Drug Administration as a member of the cardio-renal advisories panel. He spent about five years there and continued as an adviser to several FDA committees. He’s known for public policy discussions regarding drug safety; in fact he testified in the Senate and the House of Representatives on the need for FDA reform. Most recently, he’s been outspoken about the need for a single-payer health system, health insurance, or better known as “Medicare for All.” [Here the host talks at some length about the key features of a single-payer system.] …

Let’s talk about the [health] system as far as paying for it. What are your thoughts on the Affordable Care Act that is underway in America right now?

STEVEN NISSEN: Well, first of all, we had to do something. Having the richest country in human history having 50 million people without health coverage was a shame on our society, and is just not acceptable. And a lot of those 50 million people are working people. They’re people who work in jobs that are often low-paying, maybe the person who hands you your dry cleaning when you go up to the window, or in a fast food restaurant, and we have to be a civil society. We have to provide health care for everybody. Nearly every other developed country does that. They have universal health care systems, and we didn’t. The Affordable Care Act is a compromise that was forged through very difficult political discussions. And it’s far from perfect. I would have gone much further than it went, toward a simpler, universal health care system, but it did move us in the direction of making certain that everybody – or at least most people – have access to health care. To the extent that it did that, I support it, even though I recognize there are flaws in the way the law was designed. The flaws come out of political compromise. It wasn’t written by, necessarily, by a single party. It had to get some bipartisan support to get anywhere.

HOST: Yes. The single-payer system, it’s been, I guess, proven to work in a number of countries – you even referenced that a few minutes ago.

NISSEN: It does. I mean the Canadian system is excellent. They spend about half of what we spend, and a lot of what goes on in America is making us uncompetitive as a country is that we spend so much on health care and we aren’t any healthier than other people. A single-payer system is pretty simple. I mean if you want to think about a single-payer system, there’s one in place in the United States for people over 65. It’s called Medicare. Let me give you a fact about Medicare. The overhead for Medicare is about 3 percent. What that means is that 97 percent of what Medicare spends, it actually spends on for health care for people. The overhead for the private insurance industry is 29 percent, which means that almost one dollar out of every three is going for profit, for who knows what – I mean, trying to figure out who’s going to be covered and who’s not. Medicare is much more efficient, and so you can automatically reduce tens of billions of dollars in expenses just by making certain that you have a system like Medicare. There was a proposal during the health care reform debate to simply allow people to “buy-in” to Medicare, that is, use their own dollars to buy Medicare coverage beginning at age 55. I strongly supported that idea, but I supported it only because it was a bridge toward a true single-payer system. And what I hope would happen is that we’d get people to buy into Medicare at 55, then come back in a few years and say 50, and then we’d say 45, and the next thing we know, everybody could buy into Medicare and they would have had an efficient, high-quality system that worked. We don’t have that. Now what we have is the Affordable Care Act which really is trying to reform the insurance industry, not replace the insurance industry. I want to replace the insurance industry.

HOST: So they’d be out of it altogether.

NISSEN: Get them out of it. Their motives are profit, their motive is not making people healthier, their motive is making money. And the other part about the system that’s really challenging is that physicians, still many physicians, work on what’s called a fee-for-service basis, which means that the more they do to you, the more money they get paid. We work on a different model at the Cleveland Clinic. We’re all salaried. I get exactly the same salary every month, whether I order a cardiac catheterization or some other fancy test for you or not. There’s no incentive. There’s really no incentive to do things that aren’t really needed. Unfortunately, we are in a system where there is an incentive, and it is a perverse incentive. It’s one that says, the more stents you put in, the more money you make. And that is a problem, because it misaligns the needs of the patient and the interests of the patient, and the interests of the physician. In a single-payer system that works, we’d all be on salary. We would be [concerned about] quality care, but not on a fee-for-service basis.

HOST: Aren’t you restricted now by the insurance companies? Don’t they say, “Well, you can’t do that because it’s not covered”?

NISSEN: Well, they have all kinds of rules, but the rules are about profits. The rules aren’t about health care. They put restrictions on because they have to receive X amount of dollars from people to cover them, and the less care they can provide, the more money they make. That’s a very different situation from a situation where your physician is saying to you, “This is what I need to do to keep you healthy.” I just don’t want those decisions that are made by physicians to be excessively influenced by profit, by money. I want them to be influenced by what people really need in order to stay healthy.

HOST: Doctor, how many people at the Clinic have the same view as you on this?

NISSEN: I think probably a minority. I think medicine in general has been on the conservative side politically. My views are much more progressive. I’ve always felt very strongly about these kinds of matters, going back 30 or 40 years, to when I was a college student. But I’m influencing people and there are increasing numbers of physicians in America that are beginning to say, “The system is broken. We need to fix the system. Here are some things we can do to fix the system,” and the first place to look is how we pay physicians. Honestly, I think if we could get physicians on a salary basis, that would go a long way, and if we could then get to a point where we didn’t have insurance companies figuring out how to squeeze every dime out of the system, but rather a system that says, “How we can take better care of patients?” then that would be a single-payer system where there would be a government insurance plan, everybody would get it. You know what’s amazing about Canada? If you were to go to Canada, and you were to be in a terrible car wreck, as an American, and go to a hospital there, you’d never receive a bill. You could be in the hospital there for weeks and basically it’s just assumed by the Canadian society that if something happens to you, and you get sick, you should be taken care of. There’s no system there for billing people. You just go in and you get taken care of.

HOST: Isn’t that amazing?

NISSEN: And not all these insurance forms and all this kind of pre-qualification, and basically it’s patient-oriented, it’s oriented toward the public need. And I believe that’s the right thing to do.

HOST: You know it’s a real shame that in some many states, so many governors, especially in conservative states, have opted-out of Medicaid.

NISSEN: That’s just terrible. I mean what they’re saying to the poorest people in the society is that “We don’t care about you. We’d rather make a political point than support your health.” It’s unconscionable, it’s unacceptable, and the public shouldn’t put up with it.

HOST: You know there’s an organization – you’re not part of Physicians for a National Health Program, are you?

NISSEN: I’m not.

HOST: You might want to check them out. We’ve had some of their members on this show. Just go to pnhp.org, or just google single-payer health care and it will take you right there. They report that more than 7,000 people died because of the governors in those states opting out of Medicaid. People just didn’t get their health care.

NISSEN: What a tragedy. I know.

HOST: That’s a story that should be on the front page.

NISSEN: I know. And the other thing is, what’s the mission of medicine? What’s the oath that we take when we become physicians? It’s to heal the sick. And I don’t care what the politicians think, what I care about is the person in that exam room with me is my patient and deserves whatever I can give them. And I don’t want the payment system to get in the way of people getting good health care, because it’s not a privilege, it’s a right. And in most modern, developed societies, it’s understood to be a right, not a privilege of wealth. It’s part of being a human being and living in a country that fortunately has the resources to do this. We have the resources to get everybody good health care. We just have to have the political will to make it happen.

…

HOST: What’s your mission here, are you going to become more active in order to push this?

NISSEN: Well, I spend a significant period of time talking to people on Capitol Hill and you noted earlier I’ve testified on these matters in Congress and I will stay engaged in the political process, as much as I find it difficult in many ways. It’s not a lot of fun. And I continue to talk to my fellow physicians about why I think we need to be advocates for change. And we’ll see. I’m hopeful that over a period of many years we will gain more support. If we can get more physicians behind this concept we will gain momentum. There are powerful economic forces aligned against what we want to do. I mean, talk to the Koch brothers. They have a different mission, and their mission is to figure out how to pollute the environment and get away with it. And I want to fight back and I’m doing it because I really care about the patients and I think that’s part of the role of a physician, to be an advocate for patients. We will continue to be advocates and there are a number of us in Cleveland, there’s an organization of physicians in Cleveland, that gets together periodically and talks about these things and we’re going to continue to do that.

Time markers for key audio segments of show, the full hour of which can be found here: http://awfradio.com/todays-show-8-15-14/

Ed “Flash” Ferenc’s introduction of Nissen and Ferenc’s explanation of single-payer national health insurance can be heard from the 1 minute mark to 4:42.

Dr. Nissen’s comments on drug safety, the FDA, and Big Pharma take place from 13:40 to 20:30.

Dr. Nissen’s comments on the hazards of using the Internet to get medical advice run from 20:30 to 22:50.

Dr. Nissen’s comments on single payer run from 24:30 to 38:00.

By John Tozzi
Bloomberg Businessweek, Aug. 18, 2014

Sovaldi, a highly effective treatment for the liver disease hepatitis C, has faced backlash in the U.S. over its price tag: $84,000 for a three-month course of treatment, or about $1,000 a pill. The private insurance industry has pushed back hard on the price. State Medicaid directors have said they are concerned about the cost, and paying for the drug is also problematic for prison systems, which must provide health for a lot of inmates who acquired hepatitis C by sharing needles.

Meanwhile, in the U.K., regulators just approved the use of Sovaldi as part of treatment for hepatitis C. The country’s National Health Service will pay about $700 a pill, roughly what some Medicaid programs will pay in the U.S.

The U.K.’s decision to recommend Sovaldi was far from a sure thing. But once the National Institute for Health and Care Excellence was convinced that Sovaldi is cost-effective, the decision to pay for it is simple, because one entity pays for all the medical care in the U.K. If treating a patient with costly drugs now prevents a more expensive liver transplant in 15 years, that savings accrues to the National Health Service—and ultimately to British taxpayers.

That’s not the case in the U.S., where health care is paid for by a mix of employers, private insurers, and government programs such as Medicaid and Medicare. Hepatitis C can take 20 to 30 years to cause liver scarring that might require a transplant. An insurer paying for Sovaldi now is probably preventing an expensive treatment that would have ultimately been paid for by another part of the health-care system—most likely Medicare, the federal insurance program for Americans 65 and older. Insurers don’t have much incentive to do that, even if it would save the U.S. health system money in the long run.

It’s still fair to question how drugmaker Gilead Sciences (GILD) came up with the price for Sovaldi, and why it will sell an entire course of treatment in Egypt for less than the price of one pill in the U.S. And treatment of Sovaldi isn’t the final verdict on whether a single-payer health-care system is better on the merits than the patchwork of private and public insurance programs the U.S. has. But Americans sometimes accuse Britain’s single-payer system of rationing of health care. In the case of a cure for hepatitis C, it seems the single-payer model is doing the opposite.

http://www.businessweek.com/articles/2014-08-18/sovaldi-why-the-u-dot-k-dot-will-pay-for-the-84-000-hepatitis-c-drug

By Kay Tillow
Firedoglake, Aug. 18, 2014

Despite passage of the 2010 health care reform bill, employers continue to push for cuts in benefits and to shift costs to workers in higher monthly payments, co-pays, and deductibles.

Wage increases are always trumped by this costly health care monster. Some employers, in anticipation of the $2,000 annual fine for not offering health insurance, are threatening to drop coverage and instead pay the cheaper fine.

Many companies are dropping benefits for spouses, retirees, and part-timers. Current law does not stop them. Multiemployer plans are disadvantaged by the preferable treatment available to the plans of non-union employers. The 2018 excise tax will cap the ability to bargain better health benefits. Insurance companies continue to decide what doctors and hospitals workers can use.

Unions are playing in a ball park where the odds are stacked against them, a field dominated by private health insurance companies. Unions need a new arena where they can win the battle, improve coverage, and secure it once and for all.

Unions Have a Big Stake in Winning Single-Payer

Currently, nonunion employers undercut union ones by avoiding health care coverage. Ending this unfair advantage will be, like prevailing wage law, a crucial step for progress.

With single payer, unions’ ability to win contract struggles will be enhanced.  Now, for many unions, health coverage ends within 30 days of a work stoppage or lockout, placing outrageous pressure on workers to settle for less. With single payer, health coverage never ends.

With single payer in effect, unions, including those with multiemployer plans, can use their health care bargaining power to improve pensions, sick pay, and other benefits as well as wages.

Some union retirees currently have health benefits through VEBA’s. Many of these retirees are in jeopardy of benefit cuts due to rising health costs and limited VEBA funding.  With single payer the problem is solved.

Currently, many workers are fearful of organizing because they are afraid to risk losing health insurance coverage.  That risk will be gone with single payer.

Labor can win respect and gain support from those who are not in unions by defending not only its own members but by leading the fight for health care for all.

In countries that have a form of single payer universal care, a higher percentage of the workers are in unions. In 2011, rates of unionization were: Sweden  67.5%, Canada 26.8%, United Kingdom 25.6%, U. S. 11.3%. 

The Whole Country Wins with Single Payer

Union members are not the only ones in jeopardy now. Our states and cities are strapped by the health insurance burden that siphons public funds from education, jobs, and all the beneficial programs we need.

There’s nothing inevitable about the costly health insurance system we have in the U.S. where private insurance companies dictate what physicians workers can see and what claims to deny.

In fact, the U. S. is the only major industrialized nation that doesn’t have some type of national, universal health care.

Did You Know?

• According to President Bill Clinton, the U.S. could save $1 trillion per year by adopting the health system of any other advanced country. 
• The U.S. spends about twice as much per person on health care as other industrialized nations, yet our life expectancy, infant mortality, and other outcomes fall short.
• 16% to 20% of the big private insurance companies’ premiums are wasted on marketing, CEO salaries, profits, paperwork and bureaucracy rather than health care services.
• Drug prices in countries with national health systems are a third to a half lower than in the U.S.
• Over 30 million will remain without health insurance even when the health reform bill (ACA) is fully implemented.
• About 31% of U.S. health spending is on administration, most of it waste.
• Tens of thousands of Americans die every year because of no health care coverage, and millions more, including those with insurance, forego care because of the cost.
• Studies show a single-payer health care system would save $400 billion annually, enough to cover all the uninsured and to upgrade everyone’s coverage.
• Under our employer-based system, if you lose your job, you lose your health insurance too — just when you need it the most!
• More than half of personal bankruptcies are attributable to illness and medical bills.
• With single payer, each person chooses their physicians, other caregivers, and hospitals.

The “Expanded & Improved Medicare for all Act,” H.R. 676

Congressman John Conyers Jr.(D-Mich.) has introduced H.R. 676 into every Congress since 2003.

This single-payer health care program proposes an effective mechanism for controlling skyrocketing health costs while covering all and improving health care for everyone.

H.R. 676 would cover every person in the U.S. for all necessary medical care including dental, prescription drugs, hospital, surgical, outpatient services, primary and preventive care, emergency services, oral surgery, periodontics, mental health, home health, physical therapy, rehabilitation (including for substance abuse), vision care, durable medical equipment, palliative, chiropractic and long-term care.

H.R. 676 ends deductibles and co-payments removing financial barriers to care.

In country after country, labor took the lead in championing universal health insurance. Labor’s leadership is essential to pass HR 676.

Some argue that labor shouldn’t advocate national health insurance because universal coverage would take away a major incentive for joining unions.

But countries with universal health insurance have a far higher proportion of workers in unions than the U.S. Unions can gain better wages, pensions, and working conditions if they aren’t locked into bargaining to retain essential health care benefits.

Some union members fear they would lose the level of benefits they’ve won if we had national health insurance. In fact, under the current system labor’s health benefits are threatened with every contract negotiation. With H.R. 676, all medically necessary care is covered with dental, drugs, long term care—many provisions that most workers don’t have now. Working people would have improved coverage and pay less.

That’s why it’s important for unions to take a stand for the best bill, H.R. 676, which would improve care for everyone.

There is an Alternative

Unions today face bitter opposition from attacks on workers’ rights to organize and bargain. Unions can take the offense by leading the fight for H.R. 676. By winning secure health care for everyone, unions will restore hope and confidence in the labor movement and open the door for further gains.

Over 600 union organizations, including 44 state AFL-CIOs, 147 CLCs, and the national AFL-CIO have come out in favor of Rep. John Conyers’ Expanded and Improved Medicare for All, H.R. 676. That list and a sample resolution are available on the website http://unionsforsinglepayer.org

Brochures with this message are available at cost upon request.  If your union would like to have a speaker on single payer or additional information, please contact:

All Unions Committee for Single Payer Health Care–HR 676
c/o Nurses Professional Organization
1169 Eastern Parkway #2218
Louisville, KY 40217
(502) 636-1551
nursenpo@aol.com

http://my.firedoglake.com/kaytillow/2014/08/18/unions-can-lead-the-struggle-for-single-payer-health-care/

By the editors
Managed Care, August 2014

At a time when the Affordable Care Act is widely reviled and even liberals are lukewarm in their support, Ray E. Drasga, MD, is an outlier. Based partly on his experience at a free clinic in a middle-class town, he says the nation needs a single-payer system, that the ACA doesn’t go nearly far enough in covering the uninsured. And he’s not shy about it.

Crown Point, Ind., is a typical middle-class American town. Its 28,400 residents have a median household income of $64,900, well above the state-wide average of $48,400. Only 6.8 percent live below the federal poverty level, about half the statewide average of 14.7 percent.

Despite this level of wealth, Crown Point needs the St. Clare Health Clinic, which provides free health care services in its offices on Indiana Avenue, says Ray E. Drasga, MD, the clinic’s medical director. Although a $5 per visit donation is encouraged, health care is provided without charge.

“Even in a middle-class, well-off community like Crown Point there’s a big need for health care for those who are uninsured,” says Drasga, an oncologist. “This is not a lower socioeconomic area. And yet everybody knows someone who’s uninsured.”

Coverage concerns

The percentage of U.S. adults lacking insurance coverage dropped 17.1 percent in the first quarter of 2014 to 13.4 percent in the second quarter, according to Gallup, the polling organization. The 13.4 percent average for the second quarter of 2014 is the lowest level recorded since Gallup began tracking this measure in 2008.

While this news is positive, the ACA will not cover everyone. The Congressional Budget Office estimated in April that the number of uninsured will decline from about 42 million nonelderly Americans this year to about 31 million in 10 years.

Devastating costs 

“So the uninsured will still be with us for years to come,” says Drasga. Thus, there will still be a need for the free medical care in Crown Point and in other cities and towns nationwide.

In fact, Drasga makes the compelling case that the ACA, for all it will do for many Americans, is insufficient. Instead, the United States needs a single-payer health system that provides care for all. Before he retired recently after 30 years in practice, Drasga had seen firsthand the devastating effects that no insurance has on patients, particularly on those with cancer.

“Serving as medical director for the free clinic was something I did on the side, but still I saw very clearly that there is a significant need for health insurance for everyone. And, you could see the need very dramatically in people with cancer. Every now and then we’d have a patient with cancer at the free clinic or we had people calling our oncology practice who had no insurance. As an oncologist, you just knew and they knew that lacking health insurance was much more traumatic for cancer patients than it is for other patients because the cost of cancer care is astronomical now.”

Comparative costs

In an article in January in the Journal of Oncology Practice, “Why Oncologists Should Support Single-Payer National Health Insurance,” Drasga and Lawrence H. Einhorn, MD, point out that the cost of medications in the United States is higher than it is in any other developed country. The price of medications here is 50 percent higher than it is in other countries when prices tor equivalent molecules are compared, McKinsey & Co. said in a report. In addition, the overall price of drugs is more than 118 percent higher in the United States than it is in Europe because U.S. consumers use a more expensive mix of drugs, McKinsey said. (“Accounting for the Cost of U.S. Health Care: A new Look at Why Americans Spend More,” http://tinyurl.com/US-drug-costs.)

The nation’s largest health care purchaser, the Centers for Medicare & Medicaid Services, cannot negotiate for lower cost medications. “Other countries have committees that negotiate for lower drug prices and yet we don’t. So, basically we’re subsidizing the cost of drugs for the rest of the world.”

Yet the reaction among Drasga’s colleagues was muted, he says. And when Drasga was seeking a like-minded colleague in an academic setting to serve as coauthor, he was turned down repeatedly before Einhorn agreed. A pioneer in the treatment of testicular cancer, Einhorn is a professor in the division of hematology/oncology at the Indiana University School of Medicine. He is perhaps most famous for treating cyclist Lance Armstrong, not exactly in poverty at that time, for testicular cancer. Last year, OncLive, a group of publications covering cancer care, named Einhorn one of its 2013 Giants of Cancer Care.

“Most Americans are comfortable with the status quo or people believe there’s nothing they can do,” Drasga says. “They’re waiting for someone else to act. They’re watching what will happen in Vermont, for example.”

In 2011, the Vermont legislature passed and Gov. Pete Shumlin signed Act 48 into law, calling for the state to provide coverage for all 620,000 residents of the Green Mountain State by 2017. Today, Shumlin is still trying to find the $2 billion it will cost to pay for this system each year in a state with only $2.7 billion in annual tax revenue. Cost is certainly an issue with any single-payer system, but so is attachment to our current system, even among oncologists, Drasga laments. The struggle he had finding a coauthor is telling.

“I talked to heads of departments at universities but they had ties to drug companies that do research or were partially funded by pharmaceutical companies. They had a lot to lose by speaking out about the status quo.”

$2.7 trillion

In the journal article, the first point Drasga and Einhorn made was that the United States spends $2.7 trillion for health care. Doctors fear they may lose some of their income, he says. “If you’re a physician caring for patients, you don’t want to lose your share of that income. It comes down to economics because so many people want their piece of the pie.

“If a patient has advanced breast or colon cancer, it’s not unheard of to have a bill of $20,000 to $30,000 every two weeks. After seeing the doctor and getting a prescription for some new drugs, you may walk out with a $20,000 bill. Then you repeat that process two weeks later. The sad truth is that very quickly, treatment can run up to $100,000. The average person doesn’t have that type of money.

“Let’s say you have a mass in your neck and you have no insurance. It’s hard even to see a doctor, or get a biopsy or a scan. You can’t even start your treatment. That’s why people with cancer who are uninsured do very poorly. Their survival rates are much worse.”

The current system, even after the ACA reforms are implemented fully, does not go far enough, he concludes. While more Americans have insurance this year, many have high deductible health plans, leaving them underinsured, he notes.

Ray E. Drasga, MD, is a nationally known proponent single-payer health care system. A recently retired oncologist, Drasga has seen firsthand how treating cancer can leave many families in financial ruin. This article appeared under the rubric “The Contrarians” in the August issue of Managed Care.

http://managedcaremag.com/archives/2014/8/ray-e-drasga-md-its-about-time-enact-national-single-payer-program

By Margaret Flowers, M.D.

1. The Trans-Pacific Partnership (TPP) is part of a global effort to circumvent the failed World Trade Organization talks and dramatically shift power to multinational corporations.

• While the TPP is being called a trade agreement, the U.S. already has trade agreements covering 80 percent of the goods traded with countries involved in the talks. (Williams,“Trans-Pacific Partnership (TPP) Countries: Comparative Trade and Economic Analysis,” Congressional Research Service, June 10, 2013.)
• The text of the TPP includes 29 chapters, only five of which are about trade. The remaining chapters are focused on changes that multinational corporations have not been able to pass in Congress such as restrictions on internet privacy, increased patent protections, greater access to litigation and further financial deregulation.
• Unlike previous trade agreements, the text of the TPP is classified so that only the U.S. trade representatives and their 600 corporate advisers have access. Members of Congress must go through a complicated process to see portions of the text. All that is known about the contents of the TPP is from documents that have been leaked and reports from NGOs and industry meetings. From the information available, one thing is clear about the impacts of the TPP on health care: the intention of the TPP is to enhance and protect the profits of medical and pharmaceutical corporations without considering the harmful effects their policies will have on human health. It is more appropriate to call these trade agreements “rigged” trade rather than “free” trade because they rig the rules in favor of business interests.

2. The TPP will raise the cost of health care, particularly of medications, by extending the length of patents, placing barriers to generics and giving the pharmaceutical and medical device industries greater legal standing to challenge reimbursements.

• The TPP requires “evergreening” of the 20-year patents for pharmaceuticals and medical devices. Whenever there is any change such as a new indication or a new delivery method, the patent must be renewed even if there is no added therapeutic benefit. (Nicholls, “Put health ahead of profits in Asia-Pacific trade pact,” The Australian, March 6, 2013.)
• In addition to delaying the production of generic medications through prolonged patent periods, the TPP also places barriers to new generics by prohibiting the use of data from clinical trials conducted on behalf of the patented medications for an extra three years and by limiting challenges to patents. (“Briefing Memo: Leaks at Trans-Pacific Trade Talks Confirm Obama Administration Backtracking from Bush Era Access to Medicines Commitments,” Public Citizen, Oct. 22, 2011.)
• The TPP grants greater legal standing to pharmaceutical and medical device companies to challenge reimbursements negotiated with health systems even after the reimbursement has been set and to base the reimbursement on ‘competitive market-based value.’ This means that beyond research, development and production costs, companies can factor the costs of marketing into the price. The language in the leaked texts of the TPP demonstrates that the ability of health systems in the U.S. such as Medicaid, Medicare, TRICARE and the Veterans Health Administration to negotiate lower prices for pharmaceuticals would be impaired. (“Statement: Leaked US Proposal for a TPP Pharmaceutical Chapter,” InfoJustice.org, Oct. 22, 2011; “Trans-Pacific Partnership Transparency Chapter, Annex on Transparency and Procedural Fairness for Healthcare Technologies,”  June 22, 2011; “Memo: Proposed Trans-Pacific Partnership rules could undermine drug cost containment provisions of Medicare, Medicaid and Veterans’ Health, hurting seniors, military families and the poor,” Public Citizen, June 14, 2012.)

3. The TPP will lower access to health care.

• In addition to raising the costs of medications and medical devices, the TPP requires opening the floodgates to patenting surgical procedures, treatments, diagnostic tests and even plants and animals. In short, anything that can be monetized so that profits will be maximized at the expense of affordability of healthcare. People in many of the countries included in the TPP already have limited access to care because of the cost, and the TPP will worsen that situation. (“Secret Trans-Pacific Partnership Agreement (TPP) – IP Chapter,” Wikileaks, Nov. 13, 2013; “The Australian: Put health ahead of profits in Asia-Pacific trade pact,” Medecins Sans Frontieres Access Campaign, March 8, 2013)
• The TPP contains strict intellectual property right provisions which would limit the ability to share information and technology; therefore, keeping knowledge out of the hands of those who may need it to save lives. And with the emphasis on promoting corporate profits over public health needs, innovation will be driven by that which generates the most profit rather than that which addresses significant health conditions in low income populations or important public health threats.

4. The TPP threatens public health.

• Most of the text of the TPP is written to eliminate non-trade barriers to profits such as the control of intellectual property rights, advantages given to locally-produced goods and public entities and regulations. A corporation can challenge perceived barriers to trade through an international trade tribunal, an extrajudicial legal system equivalent to arbitration that is composed of three lawyers, many of whom will be on temporary leave from their positions within corporations. The decisions of trade tribunals are not appealable to traditional courts and the laws of the nation where the trade issue occurred are not applied. This is known as the Investor State Dispute System, and it is highly controversial especially in the European equivalent to the TPP, the Trans-Atlantic Trade and Investment Partnership (TTIP). The TPP permits corporations to sue for loss of expected profits. This means that corporations can sue governments, even at the local level, for large sums of money if their laws that protect public health interfere with profits. Among the actions that could be considered interference are public health campaigns that educate about the dangers of smoking, labelling foods that contain genetically-modified organisms and laws to protect workers or that prevent polluting the environment. (Khor, “The Trans-Pacific Partnership Agreement (TPPA): When Foreign Investors Sue the State,”GlobalResearch.ca, Nov. 10, 2013.)
• The TPP will undermine food safety by lowering the standards on imported foods below those currently in effect in the U.S. It will also eliminate Buy America provisions meaning that institutions will not be able to give preference to local producers. (Paul and Cummins, “Consumer Alert: Secret Trade Agreements Threaten Food Safety, Subvert Democracy,” Organic Consumers Association, June 13, 2013.)
• Trade agreements have been notoriously bad for workers and the TPP is no exception. Previous agreements have caused lost jobs, lower wages, barriers to union organizing and unsafe work environments. Even when they contain language to protect workers, the rules are not enforced. The ISDS system will hurt worker rights even more because higher wages and regulations to protect worker health will be challenged as threats to expected profits. (“The Trans-Pacific Partnership: Lost Jobs, Wages and Workers Rights,”Communication Workers of America, Dec. 6, 2013.)
• For similar reasons, the TPP will be bad for the environment. The chapter on the environment was leaked in late 2013. It showed no enforcement mechanism for the weak regulations that are included. This means that corporations can challenge local laws that ban toxic practices such as hydro-fracking for methane gas. Large potential settlement costs can force governments to repeal those bans. (Kelsey, “TPPA Environment Chapter & Chair’s Commentary Posted by WikiLeaks, Issues for NZ,” Wikileaks, Jan. 16, 2014.)

5. The TPP is a significant barrier to single-payer health systems.

• The TPP prohibits state-owned enterprises (SOEs, any enterprise that has any form of preferential treatment from the state such as tax breaks, access to resources and capital and favorable regulation) from having advantages over private enterprises. Further, the TPP attempts to eliminate the value of public service from SOEs, pushing for greater privatization of public services. This could have a harmful impact on current public health systems in the U.S. and abroad by opening the door to privatization. (“The risk of disciplines on state-owned enterprises in the proposed Trans-Pacific Partnership Agreement,” ItsOurFuture.org.nz, Sept. 17, 2013.)
• The TPP requires SOEs to disclose any special advantages they receive and the government to give the same advantages to corporations. It also provides methods for corporations to sue governments if they believe that they are not being treated fairly. The text outlines punishments such as increased tariffs on exports from the country found in violation and suspension of any “tariff concessions” made to the country in violation on imports.
• The TPP may require that a new monopoly (such as a single-payer health system) cannot exist until the companies that are put out of business by the monopoly are fully compensated. It is not known if such language exists in the TPP because only a small portion of the text that has been leaked is available to the public. However, such language did exist in WTO texts. (Skala, “The potential impact of the World Trade Organization’s General Agreement on Trade in Services on health system reform and regulations in the United States,” International Journal of Health Services, Vol. 39, No. 2.)
• By eliminating the public good aspect of health systems and opening the door to privatization, the TPP will force the failed market-based U.S. model of health care onto TPP countries and could damage some of the top health systems in the world (Australia, Japan). Already, Aflac has gained more access to the market in Japan as part of the TPP negotiation process. (Ito, “Aflac Wins Wider Access to Japan Post’s Insurance Sales Network,” Bloomberg News, July 26, 2013.)

6. The TPP undermines democracy.

• The TPP will undermine democracy in the United States. Though the agreement is being negotiated in secret with little input from Congress, our domestic laws will have to be brought into compliance with provisions in the TPP. The process of negotiating in secret, with the participation of more than 600 large corporations, without Congress or the public participating is anti-democratic.
• The TPP gives greater legal standing to corporations to challenge domestic laws in an extrajudicial legal system without recourse. Corporations take complaints about barriers to their profits to a trade tribunal that operates as an arbitration court and does not allow decisions to be appealed. When faced with large potential settlements, local and state governments may choose to repeal laws, even those that have overwhelming public support and that protect public interests, rather than pay. As a result local governments lose control over the passage of laws, protecting their environment and controlling their budget to a secretly negotiated trade agreement.
• The president is pushing Congress to grant him trade promotion authority (also known as fast track) which means the president would negotiate and sign the agreement and then it would be presented to Congress for a brief period of review, limited debate and no amendments before an up-or-down vote. This prohibits any meaningful review of the impacts of the agreement. It excludes a transparent and democratic process.

By Jen Gunter, M.D.
Dr. Jen Gunter’s ‘Wielding the lasso of truth’ blog, Aug. 12, 2014

You know it’s going to be one of those days when one of the first tweets on vacation inquires about the closest hospital.

Victor, one of my 11-year-olds, had something in his eye courtesy of a big gust of wind outside of Westminster Abby. He was complaining enough to let me flip his eyelid and irrigate his eye on the square in front of Big Ben. (I’m sure several people thought I was torturing him).  Despite an extensive search and rinse mission no object or relief was to be found. I fretted about going to the hospital. It wasn’t the prospect of navigating a slightly foreign ER, but simply the prospect of the wait. While I am a staunch supporter of the British NHS in the back of my mind I envisioned a paralyzingly full emergency room and an agonizing 18 hour wait only to find he had nothing in his eye (the basic antechamber of Hell scenario). To ensure we really needed to go I gave Victor a choice between the emergency room and a toy store (Gunter’s 3rd rule), but he declined the toys so off we went to St. Thomas hospital, conveniently right over the bridge.

The hospital was on the aging side and a little drab, but clean and well-marked. I didn’t have to ask anyone for directions. We had to take a number to be registered, but waited less than 5 minutes. I gritted my teeth a bit in preparation for the we-are-not-from-the-UK conversation, but it wasn’t an issue at all. I offered my U.S. insurance number for billing, but was told they didn’t need it. The clerk was, however, impressed with the fact that I flipped his eyelid and irrigated his eye before coming. “Well, you did all the right things,” and looking at his red and watering eye she smiled and said. “Looks like you are in the right place.”

Registration completed, we waited to be seen by the children’s part of the ER. A registrar (resident) did a quick triage within 5 minutes of our registering (also impressed with the eye irrigation) and then a nurse did his vitals and took a history. After that we waited less than 15 minutes for the registrar to do a formal assessment. He wanted ophthalmology to do the evaluation. I was a bit surprised the ER doc wouldn’t do it, but every facility is different and when they found out that Victor was born at 26 weeks and had retinopathy of prematurity they got a bit jumpy. Everyone does. I was OK with ophthalmology checking him out. What I have learned from years of medicine is don’t mess with the local order.

We were walked over to the urgent care clinic and were warned that the ophthalmology registrar was covering the whole hospital so it might be a while. This was our longest wait, about 20-30 minutes. She was very nice (also working on her PhD). Dr. Katie Williams (she gave me permission to use her name and her photo) diagnosed Victor with a corneal abrasion and easily snagged the offending speck of dirt wedged under his eyelid.  Once removed Victor exclaimed, “It’s gone!,” and within a minute or two the redness cleared up. She put in antibiotic ointment and gave us a tube to use at home.

“So where do I pay?” I asked Dr. Williams.

The answer: you don’t. Perhaps they might bill us, she just wasn’t sure.

I was about as dumbfounded at her answer as she was at my asking.

I protested that it wasn’t fair. We had used services and I was very prepared to pay. I also have insurance that covers emergencies when out of network, so I was pretty sure I would be reimbursed at least some of the visit. However, we were just sent away. They do have my address so it is possible I will get a bill in the mail.

I am very curious what similar care would have cost in the U.S. The saddest commentary of all is that it is really impossible to tell as billing practices are so bizarre and opaque. My guess is it would be a minimum of $1,000 in America for cash (which is egregious). If I ever get a bill from the UK, I’ll post a follow-up. If anyone has had similar care in the U.S. and received a bill please do post in the comments. You can remain anonymous if you like.

But what of this idea that national health care means DMV-purgatory worthy waits, Dementor-staffed death panels, Saxon-age medical equipment, and incompetent care? Well, I can tell you we had great care at St. Thomas and Dr. Williams was fantastic. The slit lamp wasn’t brand new, but it worked just fine. Sure it’s an N of one, but I’ve been to the ER more times than I can count with my other son and this was as smooth as the best care we’ve had in the United States.

We could have hit the ER at an opportune time, but to expand my N I’ve also asked many people about their medical care while I’ve been in the UK. Not one person wanted to abandon the NHS. I’ve heard of excellent care and some care that was lacking, but the bad care has nothing to do with the “national” part. Rather it was diagnostic errors or a full hospice unit, things that I hear about with the same incidence back in the world of commercial insurance. Take away the accents and I could easily have been listening to a group of Americans discussing their care. With one exception, no one in the UK is left wondering what the price will be or gets an egregious bill.

It makes you wonder exactly what frightens Americans about the NHS?

Dr. Jennifer Gunter is an OB/GYN and a pain medicine physician whose writings have appeared in USA Today, KevinMD.com, EmpowHer.com, Exceptional Parent, Parents Press, Sacramento Parent, and the Marin Independent Journal.

http://drjengunter.wordpress.com/2014/08/12/an-american-doctor-experiences-an-nhs-emergency-room/

By Public Citizen
Press release, Aug. 15, 2014

WASHINGTON – The U.S. Food and Drug Administration (FDA) recently issued draft guidance that would let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling.

This issue is discussed by Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, in an article published in JAMA Internal Medicine today.

In June 2014, the FDA issued draft guidance for the industry on distributing scientific and medical publications about the risks of approved medication and biological products.

According to Wolfe, the guidance, as written, would allow pharmaceutical companies that believe that the FDA-approved labeling information overstates a medication’s risks to tell doctors that the risks are in fact, lower. Company salespeople could inform physicians of the purportedly lower risks by distributing peer-reviewed articles – without the agency either reviewing the data or approving it – and discuss with doctors the information about the lower risks.

Wolfe says that to protect patients and the public health, when new information supports a reduction in risk, the company should inform the FDA and provide the evidence, as is required under current regulations. If the agency is convinced, the label can be changed.

Off-label risk reduction is the wrong approach, Wolfe writes. The article also discusses how people can voice their opinions to the FDA on this by Aug. 25, when the docket on the guidance closes.

The URL link for commenting on the FDA draft guidance is here:
http://www.regulations.gov/#!documentDetail;D=FDA-2014-D-0758-0001

Dr. Wolfe’s article is available here:
http://archinte.jamanetwork.com/article.aspx?articleid=1897291

“Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: A Misguided Approach,” by Sidney M. Wolfe, M.D., JAMA Internal Medicine, Aug. 15, 2014

Public Citizen has initiated a petition that asks the FDA to not permit Big Pharma to undermine information about pharmaceutical risks:
http://action.citizen.org/p/dia/action3/common/public/index?action_KEY=12559&start=150