On the Skyrocketing Costs
Of MS Drugs: A Patient Point of View

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Last week, Daniel M. Hartung, PharmD, MPH, and coauthors, published an open-access article in Neurology on astronomical increases in disease-modifying drugs for multiple sclerosis (MS) –many developed decades ago. Notably, they report that first-generation drugs — now cost about $60,000 per year, when they originally cost about $8,000 to $11,000. Copaxone is an injection-based therapy. The original Copaxone came out in the 1990s and was part of the first-generation of disease-modifying therapies for MS. It required daily injections. Within the past few months, Teva-Sandoz introduced a new longer-acting brand formulation. The new version is injected three times per week and the company hopes to switch all on the older brand to the new short-acting brand. In fact, an ad on the Copaxone home page makes a compelling argument for the new brand: “With the 3-times-a-week dose, experience 208 fewer injections per year than with daily COPAXONE® 20 mg.” Yet just as this was going on, Teva-Sandoz got FDA approval for a generic version of Copaxone. Yet, Teva had long been adamantly opposed to a generic. What will happen to the pricing and affordability of MS drugs like Copaxone? When will the generic become available?

Patient POV asked a person with MS since the 1990s what he thought of these issues. David asked that his last name not be used. He tried one of the interferons for his MS shortly after he was diagnosed.He has been on Copaxone since 1999 and his MS has been stable. He told Patient POV: “The interferon didn’t help at all. I had side effect and flares with some disease progression.”

Learning that the first-generation MS drug prices are escalating far greater than inflation, what are your thoughts?

These are first-generation drugs that were developed a very long time ago. I don’t think the price hikes are defensible. The research and development costs are long since recovered. The manufacturing costs are not that high. The price in Europe might be a better reflection of the ‘real’ costs of the drug with a reasonable profit. David worries about people without insurance who don’t get the benefit of any reduced price an insurer negotiates. (David knows that his insurer and PBM negotiate the best rates and then establish a copay accordingly.)

David raises another reason why he thinks the price hikes are excessive. It’s not as if these drugs are orphan drugs where the market is so small. There is a significant worldwide patient population.

What do you think about negotiating prices for drugs?

 I know that when the Accountable Care Act was being considered, this came up frequently, but obviously the government has shied away from negotiating best prices, except for state Medicaid. It seems like prices go up as the market can bear and it is very hard to rein in pharma. It’s certainly a deal breaker for the new hepatitis C drugs. I wish that Medicare D would allow negotiation for better prices.

What disease-modifying drug are you on? How long have you been taking them and how interchangeable do you think these medications are?

 I have been on Copaxone since 1999. For two years before that, I tried another drug. Not only did I have terrible side effects, but I continued to have relapses with that drug. I think that patients react differently and should get the drug that gives them the best outcomes and quality of life. It can be hit-or-miss for a person with MS to find the best disease-modifying drug.

A few months ago Teva introduced its three times per week, long-acting Copaxone. Teva hopes to move all Copaxone users to this formulation. Is this something desirable?

Yes. I went on it a few months ago. It helps to not have to inject myself so frequently. I have scar tissue in areas where I have injected frequently. Another advantage of the three-times-weekly dosage is that the shots are less intrusive when I travel. But 99% is getting away from the daily shots that can be uncomfortable.

Teva/Sandoz has not said when it will release generic Copaxone. In fact, there have been numerous attempts to block its introduction. Do you think that generic Copaxone will get much market share?

Teva might have staked out its claim to market share by introducing a new dosage for Copaxone [its brand].  Sandoz has yet to establish a retail price for the generic version.  Also, if PBMs can get better pricing on the generic then there might be pressure to switch.

Have you had to go through any hoops with your insurer to get your Copaxone over the years?

Until quite recently, I needed to get prior approval for Copaxone every year for 15 years. I don’t know what my insurer was thinking. This was very taxing. It took my doctor multiple attempts to get prior approval, sometimes hours on the phone, with faxing, and misplaced papers. There were a couple of years where I was running close to running out of my medicine, which was an additional stressor. Finally, I am at the point with my insurer where the Copaxone goes through year after year without these issues.

That sounds incredibly taxing.

Yes, and if you add to this that many people with MS have secondary conditions and must take additional medications, the red tape to get your needed meds can be endless. Obviously, this can trigger MS symptoms and wipe you out.

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Homecare Workers Flood #fightfor15 Rallies,
Wait for President Obama to Act

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Home care workers organized by 1199/SEIU march in midtown Manhattan on April 15, 2015.

Home care workers organized by 1199/SEIU march in midtown Manhattan on April 15, 2015.

Homecare and direct care workers were out in droves last night in New York’s #fightfor15 rally that stretched from Columbus Circle to Times Square. Initially billed as an event for fast-food and retail workers, the #fightfor15 day expanded to home care workers, adjunct professors, and low-wage workers in general. In fact, health and home care workers lined up for blocks to participate in this demonstration. So far, home care workers have won the right to unionize in several states. This will clearly be a linchpin in moving this issue forward.

1199/Service Employees International Union (SEIU) led organizing for yesterday’s rally in New York and elsewhere. Ai-jen Poo, Director of the National Domestic Workers Alliance and Co-Director of Caring Across Generations, has been out front on in calling for radically altering the long-term-care infrastructure. In her new book, The Age of Dignity: Preparing for the Elder Boom in a Changing America, she proposes integrating access to care and affordability of care, aligning the interests of the workers, the families that they care for, and the quality of care the workers provide. At the heart of Poo’s work is the recognition that home care and domestic workers are not valued and treated with dignity. Elders don’t fare much better.

Looking at her book and other data, it becomes abundantly clear the nation’s 2-3 million home care workers live in poverty. Home care workers are overwhelmingly women, immigrants, and people of color. The health care industry does not value these workers and the workforce is often transient. According to the National Employment Law Project, in 2013, the average income of home care workers was $18,598. Is it any wonder that quality of care is an issue in elder and long-term care?

Are quality improvement proponents targeting the wrong metrics: would they do better to ensure that workers have a living wage and -fair working conditions before they check whether the elderly suffer from bedsores, get infections, or sustain falls? Are they supervised properly, available in sufficient numbers, or is the industry cutting corners?

Yet despite a mantra in health policy circles to tout value-based care, health care leaders and the medical press have proved somewhat inattentive to these pressing issues, which if addressed, would ratchet up worker quality of life, reduce burnout and workforce transiency, and enhance quality of care for patients.

It would be refreshing for health care leaders and the families to back a decent living wage for homecare and direct care workers.

But many Americans may not realize that ever since the Fair Labor Standards Act went into effect in 1938, home care and direct care workers were excluded from basic minimum wage and overtime protection. As Poo points out, this exemption stemmed from racism in the 1930s, when African-Americans provided much of the nation’s domestic work. Southern legislators refused to sign off on the Fair Labor Standards Act, unless farmworkers, domestic workers, and homecare workers were excluded from labor protective legislation. It needs to be changed.

Finally, in September 2013, the fight seemed to be over, when the Department of Labor issued its Home Care Final Rule that extended these protections to the nation’s 2-million home and personal care workers The law was slated to go into effect in January 2015. However, District of Columbia Judge Richard Leon vacated the ruling in Home Care Association of America vs. Weil. The Department of Labor has filed an appeal and action is expected sometime this summer.

Advocates for enhanced worker protections for homecare and direct care workers are hoping that the Obama administration will push this forward shortly. When President Obama ran for election, he promised prompt action on this. Hillary Clinton offered this comment on twitter last night: “Every American deserves a fair shot at success. Fast food & child care workers shouldn’t have to march in streets for living wages. –H.” Clearly advocates for home care workers will want to hear a heck of a lot more before they see Hillary or any other candidate on their side.

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Are Pediatric Guidelines for Statins Too Aggressive?

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If, instead of following the adult guidelines, doctors used pediatric guidelines to identify teens with high LDL-levels, and if universal screening was in place, another 400,000 adolescents would be taking statins. Would that increase be good or bad? Doctors disagree. Some suggest that the increased treatment would be premature and dangerous to teen health.  Results from a study, which used the Centers for Disease Control and Prevention’s National Health and Nutrition Examination Survey, published today in JAMA Pediatrics, found that about 2.5% of teens 17-21 would satisfy the pediatric statin guidelines, compared with 0.4% using adult criteria.

“The safety of statins [in this population] is completely speculative and theoretical,” said Rodney Hayward, MD, Director of the Robert Wood Johnson Clinical Fellows Program, at the University of Michigan Ann Arbor. “We really need good evidence of benefit before we take a risk like this with adolescents.”

What concerns Hayward is a trend for specialists, in this case, pediatric cardiologists, to favor aggressive treatment before the burden of proof is satisfied. “There is a tendency to view everything as safe until we have the new Vioxx.” The teen brain is still developing. Given associations between statins and cognitive problems, Hayward questions whether giving statins could have adverse neurologic effects. Statin’s effects on neurologic tissue are also concerning. It would be best if teens were physically active. Adverse muscle effects have also been identified with statin use. This is just at the time when you want kids to be physically active.

One possible exception for statin use that Hayward would use is an extremely high LDL level. He also acknowledged that there is some evidence that testing adolescents once every five years may derive benefit. Hayward still thinks that benefit would be gained if statins were begun later, perhaps at age 35.Statin benefits do not accrue until years later.

The authors urge doctors to use shared decision making in cases of uncertainty because people vary in what risks that they want to take. To my knowledge, no studies of shared decision making in evaluating whether or not to put your kids on statins have been done. I wonder whether prescribing pediatric cardiologists can present the knowns and unknowns without bias.

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As Chicagoans Vote for Mayor, A Trauma Center And
A Presidential Library Hang in the Balance

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No trauma centers exist on Chicago's southside, where the vast majority of traumatic injuries occur.

No trauma centers exist on Chicago’s southside, where the vast majority of traumatic injuries occur.

The national discussion of whether #blacklivesmatter or which lives matter comes into sharp focus when you consider the lack of trauma centers on Chicago’s southside. That’s where the vast majority of gun violence occurs and where a trauma center is most needed. Chicagoans and community-based groups want a Level 1 Trauma Center there, and with President Obama nearly set to announce where his presidential library will be, it’s no surprise that activists are tying the library to the trauma center. Obviously, based on his biography, housing it at the University of Chicago makes sense. Anywhere else would be a stretch.

You don’t have to run a needs assessment to explore need for a trauma center. A casual glance at one of the two major Chicago papers illustrates the need well. Gunshot and stab wounds are maiming and murdering residents on the southside. Homicide Watch Chicago, a Chicago Sun Times publication counts them every day, with the byline “Mark Every Death. Remember Every Victim. Follow Every Case.” The Chicago Tribune also takes note, counting 432 homicides in 2014 and in 2015, 48, at the time that this post went up.

A Trauma Center Desert

Ask any trauma center expert. They will tell you that Trauma Centers strive to treat patients during the critical first “golden hour” after an accident occurs. Penetrating injuries need rapid attention. As few as ten minutes can make a difference between life and death. That’s when you can maximize health outcomes – perhaps preventing a death or disability. A Level 1 Trauma Center has specially trained and board-certified trauma surgeons, nurses, technologists specially trained to respond to traumatic injuries.

No trauma center exists on the city’s southside. The closest trauma center is Northwestern Memorial Hospital on Chicago’s Gold Coast (where some of Chicago’s richest residents shop and live) and the second closest is at Advocate Christ Medical Center in Oak Lawn, a suburb southwest of the city.

WBEZ clocks travel times within Chicago. A recent report found athat travel times to the closest trauma center exceed recommended standards of 20 minutes for the city. To reach a trauma center from South Shore, 76% of travel times were above 20 minute; 24% were above 30 minutes.

In Obama’s keynote address at the Democratic National Convention in 2004, he asked: “Do we participate in a politics of cynicism or a politics of hope?” It’s a question worth resurrecting now, when residents of the southside of Chicago feel like they not only live in a “trauma desert,” as the experts call it, but that public officials have also deserted them. Will President Obama desert the southside of Chicago?

From a moral and ethical standpoint, a state-of-the-art trauma center on Chicago’s southside needs to be built as soon as possible.

Austerity, Poverty, and Violence

It’s no secret that residents on the southside of Chicago feel disenfranchised. Poverty, austerity budgets, and gang violence leave people with little hope. Some extremely promising community organizing has been ongoing related to the Trauma Center launched by the group Southside Together Organizing for Power (STOP) and their affiliate Fearless Leading of the Youth (FLY), the Kenwood Oakland Community Organization, and several churches. If the names scare some of you, think of the powerlessness that those involved are trying to overcome.

Death ratesThe movie The Interrupters also does an excellent job at showing community-based efforts to thwart senseless gang violence. Surely, prevention can go some ways to improving the public’s health. But it is not enough. The coalition of groups working for the trauma center view violence prevention as complex, driven by despair, unemployment, lack of services, mass incarceration, and austerity in critically needed services, such as mental health clinics, affordable housing, and public schools.

Thus far, U Chicago Medicine has agreed that a regional solution to the trauma desert must be worked out, but publicly, it claims that it does not want to host the trauma center because of the pressure it would place on staff and financial resources.

U Chicago Medicine must be challenged. It would be simple to say that building a Trauma Center on the southside would ratchet up its debt. But in 2011, U Chicago Medicine reported $1.33 billion patient services revenue that does not include endowments, subsidies, and property tax exemptions for being a non-profit hospital. There is sufficient parkland available on the southside for a Level 1 Trauma Center at the University of Chicago along with a Presidential Library that would make the community and President proud.

Meanwhile, as this story unfolds, in the backdrop, healthcare is changing across the nation. New buildings on campuses are supporting bioscience research. Hospital beds will continue to diminish as more care is provided in an ambulatory care setting. U Chicago Medicine has a sparkling new building in Hyde Park, where it has always been. Like other academic medical centers across the United States, off campus, U Chicago Medicine has been creative in targeting programs and outreach to communities that are affluent. You don’t see them looking for patients in the Chicago Defender. New outpatient care centers are proliferating in wealthier parts of town — in many cases leaving an oversupply of doctors there. Advertisements in high-end print media and television commercials target the well insured.

Tying the trauma center to the Presidential Library at the University of Chicago would be a critical step in the right direction. No other Chicago medical entity has the resources at its hand to make this happen. President Obama and the University of Chicago need to step up to the task.

Disclosure: I lived in Chicago for many years. It strikes me far more as a “tale of two cities” than New York City, where I live today.

 

 

Posted in trauma center | Tagged , , , , , , , | 1 Comment

On Brian Williams and You and Your Doctor’s Memory

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Guest post by Blair Bolles

Memories are back in the news these days. Folks are lambasting NBC’s Nightly News Anchor, Brian Williams, as a Pinocchio, building up a record of having led a more exciting life than truth allows. Williams blames the error on a faulty memory, conflating events, but his apology was more of a poo-poo than an abject wail, “I got it wrong! How could I?”

Years ago a friend and I had a small adventure in which I was the active person and he was the tagalong. Over the years I have often regaled folks with a laughing tale of what happened. Then one day I heard my friend recall the incident and as he laughed about its details, one thing stood out for me. He was the active person and I was the unmentioned tagalong. Which of us was right?

Let me just say I have always been very confident of my memories. Sadly, confidence in one’s memory is no evidence of accuracy.

For a memory can be very clear and yet wrong. I once ran across a passage in my journal that seemed proof positive that I misremembered the timing of an incident. My reaction was not, Oh, I see. It was blank-faced amazement. How could that be? I remember the whole thing so well.

Some years ago I wrote a book called Remembering and Forgetting: An Inquiry Into the Nature of Memory, which forced me to spend a year or so investigating the topic of memory. It left me doubting not just mine, but everybody’s memory. I learned that remembering is not like pulling things out of a database; it is much more like a creative act of imagination, in which a person’s biases, moods and assumptions shape the product. Also important is how closely you paid attention. Chances are, if the doctor tells you you have cancer, your attention will wander away from the rest of the medical report. You will have no reliable memory of the rest of the news.

Here’s a funny story about my book. Some years after it came out I was at a dinner party where one of the guests had not only read the book, but he added that he loved it. It turned out he was a professional memory expert who made his living teaching people how to remember names. He said to another guest that he loved my book because it was so different, unlike any other book on memory he had read before. “It opens…” he told the listener, and then he stopped. He couldn’t remember the opening of the book that he was busy praising, and he was the memory whizz, able to meet 55 people and recall their names at a glance.

So let’s not be so cocky and insistent that somebody must be a liar because after all how could he forget something like that? We are the heroes of our lives and we remember ourselves as actors amid tagalongs. We are impressed by surprises, but really complicated surprises (like a unique book) are hard to remember, just because they are surprising and don’t fit into the ready-made molds.

Part of every person’s education should include strong and convincing lessons in memory’s fallibility.

Doctor’s should not just write everything down; they should consult their notes every time. And they should not expect their patients to remember what was said. Written or video copies of the same information should be part of any medical advice. And as Brian Williams is being reminded, journalists too should consult their notes. When preparing a news story, Williams would not have accepted the uncorroborated memory of a stranger; he should not have accepted his own memory either. But that advice is hard to take.

 

Posted in memory | Tagged , , , , , , | 10 Comments

Seeing Your Doctor for Prevention,
Treating On Your Own: A Report from the Field

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First off, let me be clear: what I report below I am not recommending. My first obligation is to my readers. Also, I am grateful to Brooke Binkowski, a stellar journalist-friend, who spontaneously emailed me this story this morning. It arrived in my inbox amid a heated social-media discussion about who the real villains are in the failure to vaccinate. Also, why is it we can’t reach them. Are they the rich and entitled, the libertarians, the natural, organic folk, or who?

Sometimes, you hear a story and it makes you want to use it while it’s hot. This is a gem of a story, but it’s not really about vaccines very much. If you like it, you might want to follow Brooke at @brooklynmarie. She has a lot of great stories up her sleeve.

Here’s what Brooke wrote:

Because of who I am and where I live, I collect old hippies, you know, I feed them, talk to them, hang out with them… one of them stopped by yesterday, he’s about 70, an ex-drug runner, never has taken care of his health, has diabetes, and has had major heart surgery last year (I went to see him in the hospital.)

Anyway I said: “How have you been? He said, “Oh, I’ve been fine. I ran into complications recently, did something to my pinky toe, so I cut it off.” I said, “I’m sorry – you had it cut off?” He said “No, I cut it off myself, just nipped it off with a pair of pliers, wanna see?” (of course I did, I am one of those people)

So he’s showing it to me, it’s healing nicely, etc, and I say to him, well what happened? He said: “I’m diabetic, it was getting gangrenous, just wasn’t feeling it, so… also I decided to go off my heart meds, they were making me feel like crap.” So this guy, the ex-drug runner who cuts off his own toes and now lives out in a boat on the marina. He has a daughter. Guess what?  He got her vaccinated.

Man holds pliers to his toe. This is a likeness,  This toe is healthy and was left alone.

Man holds pliers to his toe. This is a likeness, not the toe or the man in the story.This toe is healthy and was left alone.

Posted in Patient stories | Tagged , , , , , | 2 Comments

Nursing Homes for People of Color:
Still Segregated, Still Unequal

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Benzena Tucker (center) spent the last few years of her life in a public nursing home with peeling paint and overworked staff. She had no family and had been too ill to work for many years. At her side, are two volunteers, Wendy Josephs (l.) and Ricki Lewis (r.).

Benzena Tucker (center) spent the last few years of her life in a public nursing home with peeling paint and overworked staff. She had no family and had been too ill to work for many years. At her side, are two volunteers, Wendy Josephs (l.) and Ricki Lewis (r.) Benzena provided permission to publish this photo.

If Martin Luther King, Jr. was alive today, he would be 86. If he was like many elderly black Americans, he might well end up in a nursing home ranked lower in quality and with less well-trained nursing staff than a nursing home that many white Americans reside in. The facility would likely house a disproportionately larger proportion of people of color and on Medicaid than higher-quality nursing homes.

The disparities are easy to miss. After all, what happens in nursing homes stays in nursing homes, invisible to the rest of us. The only ones who see what’s going on are the patients, family and friends, and staff. If people report lousy conditions in the homes, nursing homes often vilify them. In fact, some would argue that the industry hides behind a smokescreen of patient privacy. Yes, there are inspections. Are they sufficient to drive equal care? Apparently not. Overall, the nursing home industry has changed little in terms of providing quality care for minority elders on par with what white elders get.

Documentation of inequality in long term care for minority elders dates back to enactment of Title VI of the Civil Rights Act and the passage of Medicare in 1966, which prohibited segregation in health facilities that accepted federal funds. In 1981, an Institute of Medicine report addressed the issue of segregated care in nursing homes. The hospital industry was forced to integrate to some degree at least, but nursing homes have been left largely alone.

Contrary to stereotypes, a large Commonwealth Fund analysis led by Vincent Mor, PhD, from the Department of Community Health at Brown University, found that segregation was lowest in the South and highest in the Midwest (Wisconsin, Missouri, Michigan, Indiana, and Ohio). The study found that Cleveland, Ohio, followed closely by Gary, Indiana, were the most segregated cities for nursing homes. Additionally, black elders tended to be in nursing homes in the lowest quarter of quality ratings. Blacks were 1.7 times as likely as white Americans to reside in a nursing home that was subsequently thrown out of the Medicare and Medicaid programs because of poor quality and 2.64 times as likely to be in a facility housing predominantly Medicaid residents. Elderly black Americans are not the only groups at increased risk of going to a poor-quality nursing home. So are elderly Hispanics and probably many other groups not cited here.

The proliferation of for-profit nursing homes in an industry that was once largely nonprofit has also had adverse impacts. In this study, for-profit nursing homes have been found to have lower RN staff intensity and lower RN skill mix than nonprofits, jeopardizing patient care. Poor people on Medicaid are going to for-profit nursing homes at far greater rates in many parts of the country.

This post is a snapshot of one part of long term care, which is an immense, complex topic.

Readers would be misguided if they thought that disparities are concentrated in the Midwest and do not persist elsewhere. These two anecdotes, though not data, are telling. Friends of mine recently watched in tears as a dear African American male friend landed for a long stay in a one-star nursing home in New Jersey. The nursing home housed people of color on Medicaid primarily. My friends were inconsolable when they returned from a visit, quick to call it a “crowded, smelly, dumping ground.” I learned of another story from an older African American woman from Queens NY, a New York City government retiree. I worked with her for many years. When she felt that she could no longer keep up her house, she could not find a satisfactory long term care residence to move into. She never left home: her health deteriorated and eventually, she died at home.

These stark realities are shameful. It’s 2015. We can quibble about statistics, question cause,effect, or association, but outrage, remedies, and stiff penalties and incentives for change are desperately needed.

Posted in aging, disparities | Tagged , , , , , | 8 Comments

Happy Dogmatic New Year’s: Here’s How You Lose Weight

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I don’t have any magic bullets on weight loss to show you here, but in the spirit of this blog, I give you some voices from the street.

When the topic of weight loss came up in a phone call yesterday, a close friend advised: “Don’t make anything too interesting or tasty…because if you do, you are liable to overeat. Keep it simple. If it takes work, just forget about it.” She is using a grit-your-teeth and just do-it-strategy. This approach has a certain appeal to me. Why pretend that you are embarking on a fun adventure when you are not? I’ll probably incorporate some of this…that is as long as I can stand it.

I’ve learned a lot about portion size, tracking, not missing meals, and such over the countless forays into the world of weight loss over my years. So I’ve got some basics.

Remember those days of “eat at least five fish meals a week” with Weight Watchers…oh did I lose!! But by the third day of the third week, I thought I developed arthritis of the mouth. With a forkful of fish in my mouth, I couldn’t chew. I nearly threw up. (a feat when there is nothing in your stomach to bring up)

Yep, there’s tons of stuff out on keeping it simple, packaged foods, and prepare ahead. Another idea that my friend suggested was to: “Just buy prepared grilled chicken breasts.” She says that they are everywhere, but somehow I’ve never noticed. Recommendations anyone? She didn’t point me anywhere.

Now we’ve got the new fad: exercise in 10-minute spurts. I am eager to see how that advice pans out. But for inherently sedentary me, I might give it a go.

Another person recommended the app myfitnesspal.com. I signed up yesterday (apparently before, but I only discovered this when I tried to open a new account) …and I am so conflicted about these apps and mobile tracking. You’ve got Eric Topol running around pitching them like they are the penultimate answer to health, happiness, and the end of doctors. What does he know? I am skeptical about taking advice from anyone that tall and lanky. Then skeptics like Harlan Krumholz question the data…you have to realize that Topol and Krumholz are not weight-loss gurus. We live with uncertainty.

Then I’ve got yet another friend who says: “You don’t need those apps. Just exercise and eat right.” That’s easy for someone who just naturally loves being fit and eating healthfully…but I DO NEED SOMETHING.

I am resisting the hucksters, entrepreneurs, and evangelists…although I am still tempted by some magic item, say a Bosu ball. Anything bigger than 12 x 12 won’t fit into a New York City apartment.

Remember those old Jack LaLanne machines where you could stand and they’d claim to just grind all the fat away from your thighs if you could stand the friction…if only. You can hope.

I can’t stand the idea of paying big bucks to some weight loss center (and they are growing in leaps and bounds) or support group when I could run these places. I don’t have the bucks…and oh, there’s the regression back to baseline and worse.

I think you have to have a certain sense of humor about yourself, your fat self, and trying to lose weight. I wish we could laugh about it together a bit more – and stop being so judgmental. Plus people need to be nice to you and not offer gratuitous advice. We need some new ideas, nothing dogmatic as far as I am concerned, better ways to compassionately be together. Some more spontaneity, originality, that doesn’t involve paying out – how about that?

Posted in obesity | Tagged , , , , | 6 Comments

2014 Drug Issues: Where’s the Data, Product Hopping, Inappropriate Use, and What’s Come and Gone

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For 2015, I’d love to see headway in clamping down on drugs that don’t work, tighter regulation of inappropriate drug marketing, and more open data and transparency from industry. Is it pie-in-the-sky? Maybe. But let’s work towards it.

Patients need to be skeptical before pushing for a prescription or filling it. I’d urge you to search news accounts or blogs like mine on drugs that you are prescribed before you fill your next prescription. You might be enormously surprised and think twice before you grab your next Rx. You can send me questions on twitter @lauranewmanny or in the comments here. Below, I point to issues with specific drugs, more emblematic of the drug world than case examples that stand on their own.

Tamiflu (the antiviral drug oseltamavir for influenza) and the struggle for open data

It’s flu season and the flu vaccine will not cover some of this year’s flu strains. That still means that you should get a flu shot because the flu can be deadly. If you get the flu, you might be tempted to reach for Tamiflu, which is marketed all over television in the United States, pushed by the Centers for Disease Control and Prevention, but questioned by many respected health authorities. Massive stockpiling of the drug happened in the US and around the world. According to the US Government Accounting Office, the US spent about $1.3 billion on developing and stockpiling flu drugs like Tamiflu.

Leading the charge against Tamiflu are Yale’s Harlan Krumholz, MD, Ben Goldacre, MD, from alltrials.net, and the Cochrane Collaboration, the independent, global healthcare research group that performs evidence-based reviews. Krumholz summarized five key objections to the rampant Tamiflu marketing in Forbes: pointing out that 1) Tamiflu’s manufacturer, Roche, did not perform independent trials, nor were they independently vetted, and just 60% of randomized trial was released; 2) Tamiflu has demonstrated no benefit in reducing hospitalizations for the flu; 3) No conclusions from the trial data can point to reducing severe complications; 4) None of the data available back a benefit in terms of reduced transmission; and 5) At best, Tamiflu may reduce symptom duration by about less than a day.

After substantial publicity and hammering from these groups, the Cochrane Collaboration obtained a more complete data set and took a second look at the evidence on Tamiflu.In April 2014, Cochrane published its review, which held that “there is no good evidence to support claims that it reduces admissions to hospital or complications of influenza,” but that it did shorten symptoms of flu by half a day.

Fiona Godlee, BMJ Editor in Chief described the persistent efforts to get Roche to release all the data this way:

“This review is the result of many years of struggles to access and use trial data, which was previously unpublished and even hidden from view. It highlights with certainty that future decisions to purchase and use drugs, particularly when on a mass scale, must be based on a complete picture of the evidence, both published and unpublished. We need the full data from clinical trials made available for all drugs in current use. With the new European Clinical Trials Directive bringing in rules for future drugs, it highlights the enormous challenge we face. We need the commitment of organisations and drug companies to make all data available, even if it means going back 20 years. Otherwise we risk another knee-jerk reaction to a potential pandemic. And can we really afford it?”

Next up, I consider Namenda (memantine), approved for moderately severe to severe Alzheimer’s disease or dementia.

Last week, following an antitrust suit initiated by New York’s Attorney General Eric T. Schneiderman, a Federal judge issued a preliminary injunction that would stop Actavis, who markets Namenda, from retiring an older form of its drug to make way for a newer, more expensive form with a longer patent life.  Namenda costs about $1600 a year.

What pharma was trying to do is what is known as product hopping, where companies attempt to head off purchase of an affordable generic by eliminating the older brand. Thus, generics for the older drug cannot be made. It’s profitable — yes, but in patients’ interests, it’s doubtful.

Product hopping is a huge issue – not just for Alzheimer’s drugs, but it cuts across many drug categories. If you notice it happening with your drugs next year, check in with your elected officials, your State Attorney General. They just might be interested.

Another issue with Namenda is off-label use. It is prescribed to patient groups for which there is no proof that it works. In 2006, nearly 20% of the patients in the United States diagnosed with mild Alzheimer’s or dementia were prescribed Namenda, despite data showing that it is not effective. It’s not surprising that families are primed for Alzheimer’s drugs, given how feared Alzheimer’s and dementia are.

This post won’t review the evidence and clinical trials, but you can check out this in a paper authored by Dana Casciotti, PhD. The paper does a very good job of summarizing how overused and inappropriately used Namenda is relative to what has been shown in the studies performed to date.

Provenge

In yet another category, the prostate cancer vaccine Provenge, approved for metastatic hormone-resistant advanced prostate cancer, never caught on. In November 2014, Dendreon, makers of Provenge, filed for bankruptcy. Dendreon’s sole product is Provenge. Although the company promises to keep Provenge available, it had a rocky start from the beginning.

During the FDA approval process, it was mired in controversy and it is fair to say that urologists never became enamored with it. When I attended the annual American Urological Association’s annual meetings in 2007 and 2008 as a reporter, many urologists told me that they thought Provenge was going nowhere. These issues are covered quite well in the Cancer Letter in 2007 (behind a paywall), but the Cancer Letter offers excellent coverage.

Patient advocacy groups clamored for the drug’s approval. Also, given that treatment options for hormone-refractory advanced prostate cancer were limited to docetaxel, which had severe sides effects and only added 2 to 3 months to overall survival, the far less toxic Provenge, looked desirable.

In the early trials, several methodological concerns about the drug’s effectiveness were raised, including the failure to meet the phase III study’s primary endpoint, the claim of improved overall survival depending on a post-hoc analysis, as well as questions about the FDA’s approval standards changing in the middle of the approval process. Finally, a larger confirmatory phase III trial of Provenge, published in the New England Journal of Medicine, showed that median survival increased by over four months, compared with placebo. Provenge met muster for FDA approval in 2010. A full course of treatment cost about $93,000, which Medicare was covering at the outset, but private insurers resisted. Putting all these factors together, Provenge simply never caught on.

In closing, I want to emphasize that there are a huge number of drugs that I could have covered here. Obviously, this post is far from complete. If you find it helpful, let me know. I will cover more of these issues in 2015.

More importantly, if you like what you are reading, consider a donation to this independent blog (upper right on the front page). I spend hours researching this material and am compensated zip. I hope to bring an iconoclastic perspective and content that helps you make the best health decisions. Posts have become less frequent simply because I need to make a living, this blog is not monetizing, and no funders have risen to help out. I hope that you seriously will consider contributing.

Finally, best wishes for a healthy and happy new year! See you all after the first of the year.

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Don’t Be Too Quick to Diagnose Yourself

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Learning all you can to manage your health is clearly a good thing. Today we have more at our disposal to learn a huge amount about our health status, how to intervene to avoid a crisis, and optimize our health. But recently, I’ve seen friends make assessments of their health status that were dead wrong. One could have died. Another might have had cancer, but she thought otherwise. Maybe their doctors would have missed the seriousness of these symptoms too, but I have to hope that, in the right hands, they would do better than you and me.

When a Symptom is Thought to Be Part of a Chronic Condition

A close friend of mine who has had MS (multiple sclerosis) for decades has suffered from MS fatigue, a well-known issue for people with MS. To some extent, there is some nihilism about the fatigue in the MS community. According to the National Multiple Sclerosis Society, fatigue occurs in about 80% of people with MS. The Society cautions that outsiders may misread the symptom as “depression or not trying hard enough.” In addition, the MS fact sheet makes it clear that there is no scientifically proven treatment to deal with this symptom. So letting it be may be what people with MS do.

But while my friend was visiting, I watched him make that miscalculation, attributing fatigue to a flare or worsening of his MS. He could have died. Two weeks ago, I met him at Penn Station, for a weekend visit. He looked bushed. I immediately grabbed his suitcase and got no resistance. We went for a meal and he talked about his “MS fatigue.”

We learned the hard way that his fatigue had nothing to do with MS. He reported bouts of dizziness. We stopped to sit down several times when he was walking. Two hours later, he fell down on a NY Subway platform. When EMS got to him, his blood pressure was down to 70/40 and he was rushed to an ICU. There, the doctors spotted a serious electrolyte imbalance. He could not have managed any of this on his own. We are all thankful that he is alive and for the hospital and emergency medical care that he got.

The culprit in the collapse appeared to be a change in his blood pressure medication. Weeks ago, his doctor had added on a second medication because the first medicine didn’t control it. That medication proved ineffective so the doctor substituted another. It brought his blood pressure down too far. After he was stabilized and rested in New York, I accompanied him home, which is out of state. He’s not out of the woods yet. He still has his blood pressure pills to sort out, which he is doing with his doctor on a schedule that the doctor, not him, is arranging. He doesn’t need another health crisis.

What Looks Like Belly Fat Is Not

I also watched a dear friend attribute her bulging abdomen to postmenopausal weight gain. Never mind that she is serious about exercising and eating nutritiously. Are women so hung up about weight that we cannot realize when a change in our bodies is concerning?

What finally got her to a doctor when a friend noticing a far more swollen abdomen after not seeing her for one month.

The result: she had an 18-pound benign ovarian cyst. Here’s a similar story that articulately shows how women are quick to attribute abdominal bulge to weight gain.  Thankfully, both women had the cysts removed. In both cases, the cysts could have masked cancer.

Not Everything is A Thyroid Problem

In my own experience, I have wrongly attributed feeling hot and cold, fuzzy, or confused to my thyroid being out of whack. Like many women, I have hypothyroidism that is corrected with thyroid medicine. I have certainly had to make changes to my  medicine over the years. But this year, I learned that a urinary tract infection was the likely source of the hot-and-cold and fuzziness – and not my thyroid. I’ve seen older women in nursing homes get loopy with a urinary tract infection, with doctors simply guessing it’s dementia. Like fatigue and feeling fat, feeling hot and cold or fuzzy feels nonspecific, vague, and innocuous symptoms – perhaps something to put aside – or something that it is not at all.

Recognizing the Problem

The patient empowerment movement has made great strides in educating people about illnesses and helping us optimize our health and medical decisions. But there are limitations that we need to be cognizant of. If my fatigued friend with MS had not gotten to the hospital in time, he could have died. How long would it have taken my friend to see a doctor about her large, possibly malignant, ovarian cyst? Do we really always have the best medical information to analyze our symptoms? Can we read laboratory results and radiology scans as well as our doctors? Yes, we should have all that information because it is our’s and valuable in disease management, but having information at hand is not tantamount to knowing medicine.

 

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