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India-3The long-awaited verdict on the latest appeal by Novartis was issued April 1 , to the relief of health justice advocates and patients in India and around the world. For seven years now, Novartis has challenged India’s patent laws which apply to Glivec, their brand of  the cancer drug  imatinib mesylate ( which the company spells as “Gleevec”  in North America, to uniformize  pronunciation) , an action which portended grave global problems for access to costly drugs in general.  India’s high court ruled that the form of Glivec which the company wished to patent was not a new drug  which would merit such status. The ruling is important to assure that affordable generic forms of vital medicines can be manufactured, but advocacy efforts will continue to be needed for future  drugs.  With so much published on the case  no need for me to repeat details here , among the excellent sources for those wishing to learn more  is Knowledge Ecology International and its IP-Health listserv.

 

Back from Hiatus

This blog has been on hold for a good while now as a result of life circumstances, despite best intentions.   On the day of my last post, my very elderly father took a fall  which caused a brain injury from which he ultimately succumbed.  Although he had declined considerably in the  preceding months, and had recently acknowledged that he might need to make a change in his living arrangements, he continued as his fiercely independent self and fell on his walk to the grocery store.   The previous day I had attended the 2012 Northwest Patient Safety Conference , including the excellent workshop Safe Passage: Opportunities to Reduce Harm While Providing Care at the End of Life   by Hope Wechkin, MD, Medical Director of Evergreen Hospice and Palliative Care.  Although the topic has long been of both personal and professional interest to me, I had no idea then how very valuable her practical advice would be as I dealt with negotiating my dad’s “safe passage.”  My only regret about his last weeks is the time that I had to spend dealing with bureaucracies instead of being at his side.

But despite all my background and almost a decade of experience as  Dad’s point person & caregiver, I had to be extremely assertive to get him a palliative care referral and then a hospice referral. Never once did the medical staff ever mention these subjects, despite my father’s condition. Once on board, the palliative care team ,and later the hospice nurses, were excellent. It’s a sad commentary indeed  on our broken system that these services are not offered routinely.

My plans for the blog this year are to continue to offer news and commentary on topics and issues that may not be getting so much attention in the general media.

Here’s the invitation from event organizers:

Friday, May 18, 2012, 7:00 to 9:30 PM
Friday Night at the Meaningful Movies Is pleased to present:
The film: “THE HEALTHCARE MOVIE” And a Community Discussion with guests:
• AARON KATZ, Principal Lecturer of Health Services and Global Health, UW
• DR. REENA KOSHY, National Physicians Alliance
• DR. SARAH WEINBERG, Physicians for a National Health Program & Healthcare For All – Washington, and
• LAURIE SIMONS AND TERRY STERRENBERG, The Filmmakers
LOCATION: Keystone Congregational Church, 5019 Keystone Place North, Seattle, 98103 (in Wallingford)     
Facilitated community discussion follows the film.
For more information: http://www.meaningfulmovies.org
Event is Free and Open To the Public

This documentary provides the real story of how the health care systems in Canada and the United States evolved to be so completely different, when at one point they were essentially the same. Most people under the age of 50, in both countries, are not aware of the intensity of the political struggle that led to the universal medical care system in Canada. Nor are they aware of the public relations campaigns, still active today, that have been prevalent in the United States since the early 1900’s to dissuade the public from supporting national health care.
Produced by Canadian/American couple Laurie Simons and Terry Sterrenberg, THE HEALTHCARE MOVIE reveals the personal and emotional impact on Canadians who now have access to universal health care because of the heroism of people who took a stand nearly 50 years ago. It also reveals the continuing struggle in the United States between the fear of government intervention and the right to quality health care for all people.
Every day people are dying or going bankrupt due to the ills of the United States system. Who are we in the face of this human tragedy? If you agree that people are more important than profits, then you must watch this film.

Headline scan

Recent news of note:

Report: Debt Collectors Work In Emergency Rooms, Demand Payment Before Patients Receive Care

Abbott To Pay $1.6 Billion To Settle Depakote Probes

Discrepancies on Medical Bills Can Leave a Credit Stain

American Pain Foundation Shuts Down as Senators Launch Investigation of Prescription Narcotics

Insurers back FDA plan for new drug category

Patients Share Of Expensive Specialty Drugs Is Rising

Racial, Socioeconomic Disparities Alleged In Autism Spending

Premera tries to gut drug benefits, Kreidler says no 

and a shout out to an excellent source of news and analysis with a focus on Oregon and the broader context:

The Lund Report: Unlocking Oregon’s Healthcare System

Those who have been following the saga of the leukemia wonder drug imatinib mesylate or Glivec (spelled Gleevec in North America to standardize pronunciation) may recall that it was said to be the first medicine for which a global price was set. At the time of its 2001 FDA approval, the worldwide price was US$2400/month, for  a base dosage of  a 30 day supply of 400mg caps.  Indeed, Novartis CEO  Daniel Vasella went to great lengths to discuss and justify both the high price and the pricing decision in his subsequent infomercial-type book  Magic Cancer Bullet: How a Tiny Orange Pill Is Rewriting Medical HistoryThe Gleevec story is notable too in that the typical pharma claim that the price is justified by R & D costs, was refuted by researcher Brian Druker MD, who detailed how most of the initial work on imatinib was publicly funded and he had to convince Novartis to  produce enough of it to begin clinical trials with CML patients. Dr. Druker has also gone on record to criticize  the price being charged for Glivec.

Since then patients in wealthy countries mostly have been clamoring for their  public or private insurance to cover  the drug (and its second-line successors) not that something be done about the price that is exorbitant even in their economies. Novartis  invested heavily in worldwide patient relationship marketing for Glivec , which has contributed to this phenomenon, a topic  explored previously in this blog. In recent years,  it has become much more common to hear complaints from US patients and even some of the big-box disease associations, about the escalating price of  drugs like Glivec and  especially for new biologics. But it has  been rare to to hear demands that something be done about drug prices.

So the recent posting of a patient petition on change.org calling for action to reduce the price of Gleevec is notable:  Novartis and US Representatives in Congress: Reduce to patients the cost of the drug, Gleevec.

The introduction of the petition reads:

Novartis developed this drug in the 1990s. In the years since then the price of the drug has increased astronomically. Novartis must have paid their research costs long ago, but the price just keeps rising. Patients with CML leukemia are dependent on the drug to keep them alive. Our US representatives should work with FDA to pressure Novartis to reduce the cost

Setting aside the issue of  misunderstanding that there are no price controls on prescription drugs in the US open market and that the FDA does not regulate drug prices, the petition is significant as a reflection of the increasing desperation of middle-class privately insured patients. They are among the majority here whose insurance status and/or income levels typically disqualify them for the patient assistance programs much touted by Novartis, whose global Gleevec sales generated $4.7B in 2011.   Many US patients are now finding that the Gleevec price has skyrocketed at the same time that insurers are requiring them  to pay a much larger share of its  hefty price tag.  The situation is quite simply unsustainable.

One person who signed the online petition shared:

I started taking Gleevec June 1, 2001, when it was first approved by the FDA. It cost $2400 for 30 pills. Now, these same pills cost $7367 per month. I pay $1035 per month for insurance to cover this cost. My insurance Co. gets billed for the drug. Why has Novartis raised the price so much? …

A look at  Costco’s online pharmacy, which has a reputation, anecdotal at least, for offering “good value” retail prices on Rx meds in the US, found the following cash price for a month’s supply of an  average dose (dosage  is individualized) of  30 tabs :  GLEEVEC 400 MG TABLET      $6,264.59

While Novartis is continuing its drag on its patent fight to combat the imatinib generics already on the market in India, these cannot yet be exported to the US.  The original  US patent for Glivec expires in 2015. In 2009, Sun Pharma  filed for and received tentative FDA approval for a generic imatinib for when that day comes.

Given the power of the pharma lobby the future remains very uncertain for any relief on the price of Gleevec , but the clamor of voices from the grassroots is a healthy development.

In these times of intense attention to healthcare from all quarters of the US,  a new study by USA Today and Kaiser Health News reporters focused on community clinics.  Over the past 2 decades community clinics have  developed from origins often as volunteer-run efforts, to become a vital part of  what is called the safety-net. Frequently they now are the sole source of care available to over 20 million people, often as the only providers who will accept patients covered by Medicaid,  and for the growing ranks of the uninsured. The sorry state of healthcare access would be far worse if it were not for community clinics.  These centers will play an important role too in the reforms set to start in 2014. It is expected that many who will become newly insured  by Medicaid will be seeking  care at community clinics. Long woefully underfunded, clinics will be eligible to receive help from the $10 billion approved by Congress for expanding their  service capacity.   

The report entitled  Community clinics have odds stacked against them  looked  at almost 1200 community clinics across the country, and ranked them based on the 6 categories of performance quality measures which federally qualified health centers (FQHCs) must report to the federal government.  The categories cover care for patients with diabetes and high blood pressure, rates of screening for cervical cancer and childhood immunizations, plus timeliness of prenatal care and rates of low birth-weight babies.

Using  2010 clinic performance data obtained by FOIA request, the reporting team found wide variations in care by center,  by region of the country, and between specific centers in the same city.  Generally, clinics in the South performed worse that those in New England, the Midwest, and California. Overall, their  survey showed community clinics not performing as well as the national averages for the study parameters .

There is more context to understanding the survey results however, that was not part of the report.  The National Association of Community Health Centers issued a statement about the report which while recognizing the value of examining clinic performance, expressed concern about the wrong impressions that the media study might give:

The article disregards the better quality care that most health centers achieve when compared to care provided to other low-income patients elsewhere.  However, at least the article does reveal what few Americans realize– that every health center reports on the quality of care their patients receive….

<snip>

…When you compare the federal data that is the focus of the USA Today article with national data from the National Center for Health Statistics, health centers performed better than national averages for entering women into prenatal care during the first trimester, childhood immunization rates, reduced low birth rates and hypertension control…..

NACHC recently published its report Health Wanted – The State of Unmet Need for Primary Health Care in America  which takes an in-depth look at the factors behind the consistent and increasing demand for community clinics, the links to social determinants of health and how funding has not kept up to meet population needs.  In FY 2011 for example, only 67 out of some 1900 applications for new health center service sites were funded.

Seattle/Local Health Guide extracted localized  figures from the report to create a Washington State Comparison Chart.  Janna Wilson, Senior External  Relations Officer for the Seattle-King County Department of Public Health shared additional concerns with me  in a personal  communication, about implications and lack of context  for specific data used for the local news article:

The data provided for Public Health represents a small subset of the patients we see—our homeless primary care patients. This is because Public Health’s federal health center grant comes under a targeted program called Health Care for the Homeless. Our federal data report, therefore, is specific to our homeless patients per federal reporting requirements.  As you know, homeless patients face barriers that often exacerbate medical and behavioral health conditions and complicate treatment plans.
 

While most community health center grants and programs are for the general low-income population, some — like ours — target special population groups such as homeless people or migrant workers.  There is nothing in the USA Today article that provides this important context. That said, quality improvement is a big part of our program for all our patients, whether homeless or housed.

Following passage by both houses of the Legislature, Governor Gregoire  signed the Health Benefit Exchange  bill into law on March 23– the 2nd anniversary of the federal Affordable Care Act — before  an appreciative public audience.   Passage of the Exchange bill was the result of long hard work by civic-minded advocates, including consumers and small business owners.

 

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