Sweet Dreams (Musings on funding of Esbriet for IPF)

Updated: 18 Feb. 2015

This blog is a follow-up to Good vibrations (Musings on new research on idiopathic pulmonary fibrosis) - initially posted 1 Sept. 2014  and updated 27 Dec. 2014 - in which I discussed how physicians vary in their approaches to patients with idiopathic pulmonary fibrosis (IPF) and the drug pirfenidone (Esbriet^TM).

• To access the 4 earlier blogs on IPF: 'While my guitar gently weeps' (Musings on idiopathic pulmonary fibrosis)

The blog's title derives from one of the Eurythmics' biggest hits, often sung by Annie Lennox on her solo tours.

To our surprise in early Dec. 2014 we were notified by a representative of the company that makes Esbriet (Intermune/Roche) that Peter had been funded by Alberta's Short Term Exceptional Drug Therapy (STEDT) program to receive Esbriet.

NOTE: We were not notified by a physician but by the manufacturer's rep, an RN. She told us the drug would be available at 3 locations, one of which was the UAH Rexall pharmacy, about 2 blocks from us. She gave us their phone number so that we could confirm when the  Esbriet could be picked up. Maybe it was because the physician that got the funding is no longer Peter's respirologist, since he moved to a nearby city and we got a new doc.

BACKGROUND
Much earlier our first respirologist had applied to STEDT on Peter's behalf. But Alberta's then Minister of Health, Fred Horne, indicated to forget STEDT unless CDEC OR Canada's provinces negotiated what they deemed a reasonable cost for Esbriet. That made us cynical of ever getting Esbriet. But it turns out there was hope.

QUANDARY
So now we are delighted to have STEDT funding for Esbriet for about 8 months with these provisos:

1. DOC #1: The physician with Esbriet experience is no longer Peter's respirologist. 
2. DOC #2: The new respirologist has no experience with it  - few physicians do, given its cost - and will be on leave beginning in the next few months. 
3. SIDE EFFECTS: So far, there are none that warrant stopping the drug. Nausea, dizziness, and extreme fatigue occur but Peter's okay with them so far. 
4. LAB TESTS: The Esbriet RN also told us to get baseline laboratory results for ALT, AST, and bilirubin monthly for 6 months, then quarterly, since Esbriet may affect the liver. Our family doctor kindly wrote a standing lab request. 

DOCTOR vs MANUFACTURER'S REP

About Esbriet's significant side effects, in the absence of physician involvement, the manufacturer's representative helped. Suspect this is because the manufacturer doesn't want patients to discontinue the drug because of adverse side effects. She gave advice on how to minimize a key side effect, gastrointestinal issues. For example:

• Take pills ~5 hrs apart since Esbriet's half-life is 2 1/2 hrs. 
• Increase dosage slowly and cut back if side effects are onerous.
• She said she'd check with us later about adverse effects. And we can always call the toll free number for help at any time.

BOTTOM LINES

I admit we're an outlier, having changed physicians. But even if we still had the initial respirologist who applied for Esbriet funding under STEDT, would the situation be similar? Who knows?

It makes sense that manufacturer's representatives want to ensure Esbriet helps patients and is not discontinued due to side effects.

Alberta's healthcare system is wonderful in many ways and staffed with dedicated health professionals. But I also know from helping many seniors that to claim AHS is patient-centred is not a reality. 

Care is more cost-centred because it has to be, given the Alberta government's choice of priorities and taxation policies, e.g., tax breaks to oil companies, a flat tax that favours the wealthy, and no sales tax like other Canadian provinces. All more acute now that oil prices have tanked.

Sometimes doctor visits are similar to a factory assembly line. After 'x' minutes, you're given a clue to exit. Some docs specify you can discuss only 'x" issues. While I understand where they're coming from, and dig they need to earn a living and pay for their office's overhead, it's hardly patient-centred care. 

I look forward to learning how Peter's new respirologist manages his care using Esbriet on what will be his final journey. To be continued...

FOR FUN
Love this song and in some ways it resonates with this blog's theme.

• Sweet Dreams (Are Made of This) by Annie Lennox, Live 8, Hyde Park, London, 2005 

As always, comments are most welcome. 

Searching for a heart of gold (Musings on Alberta's health system)

Also see Idiopathic Pulmonary Fibrosis blogs 
Updated: 1 Oct. 2014

I decided to write a short blog, one in a series, on Alberta's healthcare system. Canada's health system is one of best in world yet has many problems. I treasure it but don't want to ignore reality.

The blog's title comes from a song by Canada's Neil Young.

Trying to count up all times I've visited Edmonton Emergency Rooms (ERs) in past two years. At least 8 times, driving seniors in their 90s (because they want to go to UAH in Edmonton, across the street, not a far-way hospital that requires $40+ taxi fares), or accompanying them in ambulances.

I've also visited seniors who were admitted to hospitals, or had to attend clinics, dozens of times in past two years. Plus saw doctors for myself or family dozens of times.

Random Impressions

1. Alberta's health professionals are exemplary. Most cope with awful working conditions, are overworked, yet still care, treat patients with understanding and kindness. Truly heroes worth of admiration.

2. A few RNs let it get to them and are overtly surly to patients who have the audacity to ring nursing station buzzers and are hostile to patients and visitors who dare ask questions. I call these RNs angry pitbulls who probably should leave the profession. No doubt they are overworked but it does not excuse bad behaviour.

3. A few health workers seem to have little or no sympathy for the elderly ('bed blockers') and others who belong to any underclass. Is it because physicians and RNs earn good wages, live the good life, have not experienced hard times, and had a privileged childhood with little experience with the down-and-out and human frailty?

4. EMS staff have told me that some colleagues burn out and leave the profession because they cannot relate to the elderly or the homeless.

5. I've overheard young ER nurses and doctors joke negatively about elderly patients. A coping mechanism or they're callous youth? 

6. Physicians seldom listen to patients. They're immediately on office computers accessing results and what patients say is so much background noise.

In the past, doctors used to at least read a patient's chart, stuck in a slot on the outside of the cubicle, before entering. Nowadays, they enter,ask how you are (ignore whatever you say - it's usually not 'Fine' or why the heck are you there?), immediately log-in to computer, scan test results and recent history, while patients sit quietly waiting to be acknowledged as existing.

For routine followup visits, I've had physicians ask me,'How are you? What can I do for you today?' I wanted to reply: 'Your booked this appointment. You tell me.' But instead I generously say, 'I'm here for a routine follow-up for ...', which lets them off the hook.

7. Sometimes as a patient, when doctors begin a canned spiel about what they think is your issue, you feel like shouting, "Shut the f*ck up and listen" but you never do.

I've never heard a physician ask any of , "Am I going too fast? Do you understand what I'm saying?" From my life as a teacher of adults, it's standard practice to ask learners what there background is and if they know much about "x" so as to determine how much to explain. Because doctors never do the equivalent, patients with a health care background, e.g., medical laboratory technologist, may have to suffer through a hilarious description of a laboratory test.

8. Many patients visit their physicians unprepared, without a list of key questions that need answering or concerns that need to be assuaged. This puts doctors at a disadvantage as too many random concerns dilute a patient's true needs.

9. Some physicians talk too fast, use too many medical terms, and are oblivious to patients as real people struggling to understand. They don't seem to comprehend that lay people will often be focussed on what the doctor said several sentences ago and new information is not being heard, let alone processed.

Communication is not simple. Between SENDER---> (encodes MESSAGE) and RECEIVER (decodes message to obtain meaning) much background NOISE can interfere, not the least of which are the sender's language and speed of talking and the receiver's apprehension and fear.

10. What's taught in medical schools about patient-centred care is so much bullsh*t. Once physicians set up practice, it's all about processing patients on an assembly line for 'fee for service'.

Patients can't even get long-standing prescriptions for lifelong conditions renewed without visiting doctors. Pharmacies try their best to help patients but it's strictly ka-ching, ka-ching for doctors to make their practice viable (salary, overhead costs of maintaining an office and staff, etc.)

11. I've observed senior doctors humiliate student physicians (interns, residents). It's a widespread problem, one of medicine's dirty little secrets.

12. Onus is on patients to come with list of key concerns and press physicians for answers. Few can do this, especially the elderly. Often old folks meander all over the place instead of clearly stating their serious health issues.

Meanwhile MD and RN eyes glaze over and they begin to use terms like 'dearie' and 'sweetie'.

And some doctors don't really see oldsters as patients, more as inconveniences they cannot help. No one wants to feel powerless, least of all physicians with god-complexes.

More to come...
FOR FUN
Hope you enjoy this 1972 ditty by Canada's Neil Young.

• Heart of gold 

As always the views are mine alone and comments are most welcome. 

Good vibrations (Musings on new research on idiopathic pulmonary fibrosis)

Updated: 27 Dec. 2014 

AND THE BEAT GOES ON
This new blog is to relate what I discovered

1. When generous friends wrote Alberta's then Health Minister, Fred Horne asking for Esbriet to be funded for idiopathic pulmonary fibrosis (IPF), including Minister Horne's response when I contacted him directly. 
2. Interesting tidbits from additional medical research on IPF.
3. How physicians vary in their approach to patients with IPF.

*** Plus - and it's a huge plus - a surprising update in early December (see blog's new ending). 

BACKGROUND
In 2013 my spouse was diagnosed with IPF, a deadly disease with no known cure and a median life expectancy after diagnosis of ~3 years.

Besides the diagnosis, it was a shock to learn that the one known treatment at the time (pirfenidone / Esbriet) was approved for use by Health Canada, but not funded by provincial governments.

I subsequently read many scientific papers on the issue and wrote 4 blogs that examined what it's like to get an IPF diagnosis and why Esbriet is covered by public funding in the UK but not Canada. In brief, reasons include

• The Canadian Drug Expert Committee (CDEC), under the auspices of CADTH, decided that Canada should not fund Esbriet (18 April, 2013). 
• The clinical trial results at the time were equivocal and CDEC opted for seeing the glass half empty, no doubt partly because Esbriet is expensive ($40,000 - $50,000/yr). Provinces would prefer not to pay for a drug that slows, but does not cure IPF, a disease affecting mainly the elderly.
• To access the 4 earlier blogs on IPF: 'While my guitar gently weeps' (Musings on idiopathic pulmonary fibrosis).

Although we are fortunate to have great health insurance, it did not cover a drug as expensive as Esbriet. We understand why our drug maximum is $2000/yr, otherwise the plan would be unsustainable.

HOW GOVERNMENT RESPONDS 
Many friends kindly wrote the Alberta government, usually the Health Minister, Premier, or their MLA, using a variation of the Canadian Pulmonary Fibrosis Foundations' provincial advocacy packages. Regardless of how personalized they made their appeals - including that they knew the UK but not Canada funded Esbriet - in return all, including me, received what amounted to a government form letter, which totally ignored the content of our letters.

In return I wrote Minister Horne and asked him to cut the crap and reply to 3 simple questions.

To his credit, Fred Horne replied to my direct questions. If I interpret Minister Horne's reply correctly:

1. Unless CDEC recommends Esbriet funding, Alberta won't fund it.
2. Alberta's expert committee (ECDET) accepts (rubber stamps) CDEC's decisions.
3. Forget about Alberta's Short Term Exceptional Drug Therapy (STEDT), unless a drug is approved for public funding by CDEC OR Canada's provinces negotiate what they deem a reasonable cost for Esbriet.

Alberta Health's replies were as expected. I just wish the government would be more transparent and upfront, instead of giving citizens the hope that maybe you can get your expensive drug, with unknown or iffy efficacy, under special funding. 

Maybe you can, but only if you are a cute child with a rare disease or if your disease is more common (e,g., cancer), thereby involving more voters. Cynicism or reality? You judge. 

WHAT RESEARCH SAYS

Since I wrote the prior blogs, new research has emerged on Esbriet's value in treating IPF, notably,

• IPF now a treatable disease (CMAJ) 
• Two drugs reduce the progression of IPF
• In 2014 The Journal of the American Medical Association (JAMA) reported that pirfenidone (Esbriet) reduced the relative risk of death or disease progression by 43% compared with placebo.

Accordingly, CADTH is looking at another submission on pirfenidone (Esbriet) and seeks input. 

In the meantime, Esbriet's maker, Intermune was bought by Big Pharma's Roche for $8.3 billion, likely in the hope that the U.S. FDA will approve Esbriet for use in the USA. Effects of the takeover on Esbriet's public funding in Canada remain to be seen.

A TALE OF TWO PHYSICIANS 

My spouse's initial lung specialist (pulmonologist / respirologist) is a physician with much experience, who gave Peter hope that he could get funding for Esbriet, which might significantly help, although not cure, his IPF. The doc patiently spent much time explaining IPF and its possible clinical courses.

He put us in touch with Esbriet's maker to investigate if our insurance would pay. He submitted Peter's name to Alberta's Short Term Exceptional Drug Therapy program (STEDT).

But he soon moved his practice outside our city to what is often called a 'bedroom community'. Although relatively close, driving is a challenge and I could not see travelling there for continuing care. 

Unfortunately, we quickly learned that Esbriet funding was a no-go (as explained above in correspondence with Fred Horne). The original respirologist was hopeful that it would eventually be funded, especially if enough people drew the Minister's attention to the issue of IPF and Esbriet / pirfenidone. Thus, we asked friends to write the Health Minister.

In a pulmonary care exercise program with an Edmonton primary care network, we were told that IPF could deteriorate quickly at any time (acute exacerbation), and we needed a physician to manage it. We opted for a respirologist who was younger and therefore the wait time to see her was less and was affiliated with the University of Alberta Hospital, the facility closest to us.

Her approach was caring but more or less 'all business' and straight forward.

• She reassured Peter not to worry about no Esbriet funding. The drug is not a cure for IPF and has significant side effects. 
• Her approach was, Let's take a few key tests (lung function, echocardiogram, CT scan, 6 minute walking test, review earlier sleep apnea test results) so that she could assess his current medical condition. 
• Then she would discuss where he was at and treatment options.

We appreciated this approach: Let's assess the current state of the disease. What can we do, if anything?

LEARNING POINTS
Some of the key things we've learned:

1. Public advocacy programs for government funding of expensive drugs to treat incurable diseases are worthwhile but work better under certain circumstances.

• Many voters are mobilized to advocate the cause. 
• Helps, but does not guarantee success, if
• Celebrities participate
• Disease is common
• Victims pull at heart strings 

2. Government funding of drugs is shrouded in smoke and mirrors. 

• Health Canada approval does not equal provincial funding.
• Governments seem content to let advocates 'piss in the wind' and only fess up to reality when pressed.
• Provincial exceptional drug therapy programs to fund high cost drugs for rare conditions do not apply to drugs unapproved for funding by CADTH's CDEC. [Except perhaps for children with heart-wrenching diseases like this little girl.]

3. Lung specialists vary in their approaches to dealing with patients with life-threatening, incurable diseases.

• One approach does not fit all because communication involves a communicator (Dr.) and a recipient (patient), and recipients vary greatly in their ability to accept harsh facts. 
• In our case a reality-based approach is okay. 

4. Evidence-based medicine is highly touted and used to denigrate or justify many treatments. But often the evidence is not there or is conflicting or flawed or tainted by private interest and politics. 

• Canada's CDEC clearly puts cost-effectiveness first. No doubt cash-strapped provinces prefer this. 
• Otherwise, why would the UK's NICE committee recommend funding Esbriet to treat IPF, and Canada's CDEC recommend the opposite, based on the same evidence? 
• For the record, NICE's 64-page report is transparent and discusses all issues in detail. CDEC's report is 5 pages. 
• UK experts noted that it was unlikely that clinical trials for IPF treatments can ever have enough statistical power to detect a difference in mortality. They recognized this limitation.
• Yet new studies show Esbriet reduced the relative risk of death or disease progression by 43% compared with placebo.
• Canada's experts chose to ignore statistical power.
• Statistical power: Ability of a study to detect a real difference, if one exists. Power is affected by how big the difference is and sample size. If a difference is big, it's easier to detect. And large sample sizes make a real difference easier to detect. 

5. Autopsies show that IPF coexists with many serious conditions, making diagnosis and treatment options difficult. As an example, 

• In discussing why spouse's lung biopsy showed evidence of pulmonary hemorrhage, not one specialist could explain it. 
• Seems medicine remains both a science and an art. 

UPDATE
Miracle of miracles, early in Dec. 2014 we learned that the Alberta government would fund Esbriet under the STEDT program. For this we thank Peter's initial respirologist, Dr. Lyle Melenka. See

• Expensive drug for deadly, rare lung disease funded by Alberta government (24 Dec. 2014)

FOR FUN
As Peter and I deal with a diagnosis of an incurable disease, idiopathic pulmonary fibrosis, we focus on the glass half full. Every day, every month, every year is a blessing.

Which brings me to an old but fabulous Beach Boys ditty.

• Good vibrations (Love this song)

Further Reading

• Autopsies in acute exacerbation of idiopathic pulmonary fibrosis (Interesting findings. Perhaps they can be of use in treating IPF.) 
• Acute exacerbation in idiopathic pulmonary fibrosis. 
• Clear diagram of the 3 types of disease progression in IPF.
• Drugs for rare diseases. Evolving trends in regulatory and health technology assessment perspectives (CADTH, Aug. 2013)
• Quote in Summary on Alberta: 'A Short Term Exceptional Drug Therapy program for funding high-cost non-formulary drugs for rare conditions is available for both in-patients and outpatients.' [In theory, not in practice.]

As always, comment are welcome.

Simple is as simple does? (Musings on what can go wrong when buying a bed)

Updated: 21 July 2014

Note: To see 4 posts on idiopathic pulmonary fibrosis (IPF) see 'While my guitar gently weeps' (Musings on idiopathic pulmonary fibrosis)

This is the first in a series of farces on what can happen when you try to help senior pals  in Edmonton, Alberta, Canada. The learning points apply to any business and their  customers.

This isn't a senior story per se but rather what can happen with national department stores, or any large retailer, that has communication and computer (information system) issues.

This farce outlines what happened when I bought a bed from a Canadian icon, The Hudson's Bay, for a senior friend who was in hospital. Note that in 2008 The Bay was bought by a U.S. company that also owns Saks Fifth Avenue. Key points:

1. On 4 June 2014 I bought a twin bed from sales rep Robert at The Bay Southgate for my senior pal, who was in hospital.

2. Bed was scheduled for delivery on 19 June.

3. Surprise! Mattress and box spring arrived but no bed frame. Delivery guys said the 'no frame' bit happened often.

Which motivated my spouse to draw this sketch:

Thus began a series of MANY phone calls to The Bay (and tweets to @TheHudsonsBayCo) to investigate what happened and how to resolve it. My calls were to the bedding dept. at The Bay Southgate in Edmonton, to manager of the dept, to customer support (which turned out to be in Toronto - several calls not documented below). Customer support in Toronto, once on the file, worked to resolve the issue and keep me informed.

4. I called The Bay's bedding dept. manager as the sales rep was not in that day. He said he or the sales rep would call with follow-up.

5. When neither called, I called the dept. and got the sales rep. [Turns out the rep called my pal's number, but she was in hospital.]

The original sales rep said he told me frame was not included as often customers simply used their old frame. But he had not told me and he apologized when I called him on it. My pal had a queen bed but was switching to a twin bed, so the old frame was unsuitable.

6. Robert said he could offer a frame without castors for ~$39.

7. I asked for frame I'd bought yrs earlier for ~$119 with castors and that I knew was good.

8. The rep said there was one in Vancouver that he'd have sent to Edmonton. He'd call when it arrived, likely in about 1 week. I stressed to call me as my pal was in hospital for extended period.

So far so good but then....

I was not called when frame arrived. Instead my pal in the hospital was called. I discovered this later (after #9 below) as I monitor her phone messages periodically.

9. After 10 days I called The Bay bedding dept. and spoke to another rep (Ralph), as original rep was on a day off. Ralph investigated and arranged for frame to be delivered on 9 July (plus assemble bed and remove old frame).

10. I waited but frame wasn't delivered on 9 July and I was not called. Instead I later discovered they'd called my pal, who was still in hospital.

11. On July 12 I went to The Bay and spoke to Ralph. He said the computer system had shown the bed frame to be in Calgary on 8 July, making a 9 July delivery possible. Now the computer showed it was to be in Calgary on 22 July (which was inexplicable). He would ask the original rep to follow-up.

When accessing the computer system, the sales rep's face showed he was frustrated. Another sales rep watching had facial expressions and body language that agreed.

12. Original sales rep did call me back the next day and told me the bed frame was in The Bay Southgate but the computer would not allow him to release it. He would contact The Bay's 'Top Clerk' and see if she could release the frame.

13. Robert followed up and confirmed the bed frame would be delivered Fri. July 18 and would be assembled and the old frame removed.

14. It  happened. A happy ending after MANY phone calls.

LEARNING POINTS
My take on this farce of what should have been a simple transaction of buying a bed:

1) Because the delivery guys noted that customers were often shocked that a box spring and mattress arrived without a bed frame, The Bay should correct what may be a systemic error.

2) The Bay's sales reps should pay careful attention to what customers say (such as CALL ME, not pal who's in hospital for extended stay).

3) That its computer system would not release a product suggests major issues with The Bay's information system.

4) The Bay has communication issues, a common problem with large, national organizations.

5) To be fair, The Bay employees truly tried to remedy initial screw-ups / glitches and eventually succeeded. I appreciate their efforts.

As always, comment are most welcome.