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Archive for the ‘Global Health’ Category

Consumer info fact sheets  translated into WA’s threshold written languages   (Chinese, Lao, Khmer ( Cambodian), Korean, Russian,  Somali, Spanish, and Vietnamese) were posted on Dec. 16, just one week before the deadline to start an application for coverage to be effective Jan. 1, 2014. In an unrelated development, HBE  decided on this brief extension  for completing applications due to various  problems people have had in being able to use the online forms and or access phone customer services.  Regarding the translated fact sheets, it’s taken almost 6 months for their publication to replace the original problematic versions that were taken down from the site.
However, the new fact sheets are not easy to find as they are not posted on the consumer website,  but located exclusively on the HBE corporate website.  The corporate site features a line at top right-hand side of homepage entitled “Information in Other  Languages” which links to the fact sheets page, plus also links out to the consumer website.  In contrast, the consumer Healthplanfinder site (which is in both  English and Spanish) does not offer any such subject line, nor does it display a link to corporate site.  The Healthplanfinder site likewise does not contain any readily visible clear statement of consumer  language access or disability access rights, except for a message in tiny font on bottom of the homepage that says [sic] : If you need additional language or disability accomodations, you may call 1-855-WAFINDER (1-855-923-4633)  On the Spanish version of the website, this statement illustrates yet another example of  faulty translation, as the term “disability accomodation” is twice translated, and very ungrammatically, as  “discapacidad alojamiento”  which means disability lodging.  Sure enough, a quick check on Google Translate  English > Spanish reveals  “lodging” as the first  translation for “accommodation.”  Since 2012 advocates had been recommending the inclusion of multilingual tag lines and/or translated summaries sections for the website. Interpretersymbol

Information on some metrics for the Healthplanfinder call center became available last week with the release of the  November Healthplanfinder Data Report. On the language access side of things (p.10 of the report)  the numbers are not encouraging: the call center received almost 12,000 calls in Spanish, but handled only some 1600 of them. The call center in Spokane has bilingual Spanish-English staff (reported as 6 out of 80 employees at start-up) on site and routes calls in other languages to a telephonic interpreter service. For calls in all languages besides Spanish combined, 1045 were actually handled (answered)out of 3621 calls attempted. The report does not state if the multilingual calls are included in the totals for approximately 35,000 calls  handled in November or the almost  158,000 calls throttled (deflected from the system, i.e. not put into the queue to await a response).  While the HBE is said to be increasing staffing for the call center,  any increases planned for its language capacity are as yet unknown. Given the demand, it would seem that Spanish-speaking callers too could benefit from immediate access to interpreter services.

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The irony was not lost for me that while writing on the positive results of the FDA’s use of  translation services, that here in my state, once known as a national leader in language services, we are still struggling to get quality translations for our Health Benefits Exchange (HBE).  The efforts  to achieve this goal have been a major focus for the Washington State Coalition for Language Access, and its been a year now since we co-authored with Northwest Health Law Advocates the report Language Access in Washington under the Patient Protection & Affordable Care Act  expressly for the HBE efforts. Now with 175,000 enrollees, Washington State deserves the praise it’s getting for the record-breaking enrollment figures in the new health insurance  marketplace Washington Healthplanfinder, WA_Healthplanfinder_RGBespecially compared to the situation in neighboring Oregon and to the federal Healthcare.gov platform. But the picture is much less rosy regarding providing equal access for Washingtonians with limited English proficiency (LEP), who now number some 8% of state population or half-million residents, representing an increase of 210 % in the past decade . Demographic data on enrollees is said not to be available.

We are now less than 2 weeks away from the enrollment deadline for coverage to start Jan. 1, 2014, and the consumer fact sheets that were intended to inform the public of the options under the ACA have not yet been made available to Washington’s LEP population. Even though work began in July to replace the problematic original translations – errors brought to HBE’s attention by advocates- there are still no consumer fact sheets available in Washington’s  threshold languages ( in written form these are: Chinese, Lao, Khmer, Korean, Russian, Spanish, Somali, and Vietnamese).

In addition, the Spanish versions of the paper application for Healthplanfinder, while continuing to be publicly available, have contained horrific translation errors.  In the section  which inquires about the applicant’s citizenship status, the phrase ” Non-citizen legally present in the US”  was translated into Spanish to mean just the opposite,  i.e., the translation says “ non-citizen not legally present….”  ACA, complete with the  I-word in Spanish in version #1.  After the mistake was identified on Oct. 15 , again by advocates,  staff said they took immediate action to have the vendor correct it.  The screenshots included here show the sections containing the mistranslations.

Spanish version #1

And yet, advocates identified that the new translation contained the same error, just written with different wording.   Here is Spanish version #2, as it appeared on Nov. 14: Screen shot 2013-12-05 at 11.00.31 AM

This one particular error may now have been recently corrected  for a 3rd iteration, through volunteer  efforts of local language access advocates trying to beat the clock to help consumers. However, we hear anecdotally that more translation concerns persist and can’t be confident that there are not similar errors in the translations in the other languages.

What remains a mystery is how this sorry state of affairs has come about, and if there were ever robust quality assurance measures in the procurement chain for the translations. It is beyond comprehension how such blatant errors could be made given that the work was done by vendors holding official State contracts who must affirm that they use  qualified translators and proper translation procedures. And if this is happening in Spanish, the 2nd most used language in both our State and nationally,  and thus one for which there is an ample number of nationally-certified translators available to do the work, there is a real reason to fear that similar egregious errors may exist in other language translations.

Shortly before Thanksgiving, HBE staffers announced  at a meeting of its Health Equity Technical Advisory Committee, that work halted back in June to create a Language Access Plan  (LAP) for the HBE requested by the TAC , will resume in the new year.  LAPs are meant to serve as blueprints to guide the work of agencies and programs to comply with the laws requiring they provide language services, and  to help prevent the kind of  problems that we’ve being seeing here in the other Washington.  I’ll continue to report on the work in progress.

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Two recent news stories about honey, illustrate yet again the vital importance of communications to health.  In these completely unrelated cases, it was all about translations, the rendering of messages from one written language to another. The fraudsters seemed to have assumed they could get away with selling their products to unsuspecting consumers due to a lack of language skills on the part of regulatory authorities.

In September,  Bloomberg Businessweek  broke the story on a honey scandal at the global level with an article entitled The Honey Launderers: Uncovering the Largest Food Fraud in U.S. History , describing a convoluted plot by German company ALW to sell millions of pounds of Chinese honey in the US, by disguising its origins.  Over the course of several years, ALW arranged with the Chinese brokers to channel their product through other countries, where it was filtered, doused with additives to disguise its unpleasant  flavor, and re-labeled  to make it seem to have come from nations authorized to export honey to the US.  Some of the adulterated honey was also found to contain residues of the antibiotic chloramphenicol, long banned in the US.  The impetus for the fraud was purely financial , as honey fetches top dollar in this country, the major world consumer.  Over a decade ago when domestic beekeepers complained that honey imports from China were seriously undercutting their business, the US imposed such stiff tariffs on Chinese honey imports that little enters the country legally any more. But the super-cheap price of honey in China has remained a lure for international exporters. Some Chinese feat_honey39chart_630producers seize this opportunity to increase their own profits by artificially  increasing the quantity of honey available to be sold.  According to the FDA investigation of this case, a number of  techniques like harvesting the honey early and not letting the bees complete the process naturally were routinely used in China, along with machine-drying the honey to speed things along.  ALW abetted the process and instructed its 2nd-country middlemen to add  sweeteners to disguise the sour taste caused by the premature harvesting.

In order to keep the doings secret, ALW  officials exhorted the young German employees sent to run the firm’s US operations to use the phone, not emails, to discuss business and to conduct all communications in their native language.  While the staff did restrict their discussions to the German language, they continued to use emails for correspondence. Their missives were later translated into English during the course of the FDA investigation.  The federal  prosecutor who worked on the case commented:

“They were extremely sophisticated and intelligent in some ways, but so sloppy in other ways. What do they think—no one can translate German?”

Earlier in the year in a less notorious case, the honey firm Nature Nate’s in Texas garnered FDA censure because it violated the instructions issued by the FDA following a 2012 audit, when the company was ordered to stop advertising its honey in ways that characterized it as a drug, i.e. by making various health claims for its products.  While Nate’s had promised to stop the spurious marketing by Fall of 2012,  an FDA follow-up in mid-2013 found that the firm continued to make these claims on its Spanish-language website,  under the banner ” Remedios Caseros con Miel or Honey Home Remedies “, Spanish_honey_remedies describing such benefits (in English translation) as:

• “Food Poisoning. Blend 1 Tablespoon Apple Cider Vinegar and 1 Tablespoon of North Dallas Honey dissolved in a glass of chilled water.”

“‘[O]rganic honey’. A client of mine that is a doctor told me to try yours for allergy relief. It has COMPLETELY eliminated allergies for the entire household … it is our daily dose … “

A cached copy of the Spanish information on how to use Nate’s honey as an arthritis remedy said:

Para la artritis – 100% Pure Raw & Unfiltered Honey naturenates.com/espanol/para-la-artritis
“Receta 1. Tome una taza de agua caliente con dos cucharadas de miel y una cucharadita de canela en polvo por la mañana y la noche. …

FDA translation: “May Help with Arthritis. Recipe 1. Take 1 cup of hot water with two spoons of honey and one small teaspoon of cinnamon powder both morning and night. .. “

The FDA issued the new warning letter in June 2013, and Spanish version of  Nature Nate’s  website appears to have now been taken down.

And the phenomenon of the FDA using translation as an investigative tool is hopefully now a regular practice, as a evidenced by yet another recent case, this time involving the Sundial herbal supplement company which got an FDA Warning Letter based on claims made solely in Spanish which characterized its products as drugs.  As a commentator for Regulatory Affairs so aptly explained

…just because a product’s unapproved claims aren’t in English, that doesn’t mean FDA isn’t paying attention.

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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.

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As the new year starts, some ome items of note from near and far:

The breast implant scandal strips away the glossy euphemisms of cosmetic surgery

S. Korea approves Asia’s first anti-leukemia drug

Nicotine Gum and Skin Patch Face New Doubt

No Benefits for Sick Job Seekers: After battling leukemia, man is denied unemployment benefits

Opinion: Why are Washington’s nonprofit health insurers sitting on huge surpluses?

“Gizmo idolatry,” robotic prostatectomy, and real data

Final Thoughts from A Dying Cancer Researcher

Number of uninsured in WA hits 1 million

Drug research routinely suppressed, study authors find

FBI crackdown on unproven stem cell therapies

 

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Moving forward

Regence fined $100K for denying women coverage

[Washington] State Insurance Commissioner Mike Kreidler has fined Regence BlueShield $100,000 for denying contraceptive coverage to 984 women.

Regence had covered the women’s use of an IUD, or intrauterine contraceptive device, but not the removal of it. When the women wanted to remove the device because it was outdated, or because they wanted to get pregnant, the insurance giant did not consider those reasons as “medically necessary,” state officials said Monday.

“There’s an important lesson here,” Kreidler said in a statement.

“If you believe you’ve been unjustly denied coverage, don’t just accept it, call us. Of the 984 women who were denied contraceptive coverage by Regence, only three appealed the decision – and all the denials were upheld.”

He said one woman’s call to his office resulted in coverage for nearly a thousand other women who were denied coverage over the span of eight years.

Going backward

Tobacco Giants Sue to Block Graphic Warning Labels

Five tobacco companies have filed suit against the U.S. government claiming that government-ordered graphic warning labels on cigarette packs violate their First Amendment rights.

Starting on Sept. 22, 2012, cigarettes sold in the U.S. will have to carry graphic images warning of the dangers of smoking. These images include a tracheotomy hole, rotting teeth, diseased lungs, and a body on an autopsy table.

The images will be accompanied by dissuasive wording on cigarettes and smoking, including “cigarettes are addictive,” “cigarettes cause cancer,” and “smoking can kill you.” They must be displayed on at least half of the front and back of cigarette packs, and 20% of the top of the pack.

The lawsuit was filed by four of the nation’s largest tobacco companies — including R.J. Reynolds Tobacco and Lorillard, and one smaller company (Sante Fe Natural Tobacco Company) — against the FDA and the Department of Health and Human Services.

The companies are seeking to prevent enforcement of the images, arguing that the government cannot legally force them to espouse an anti-smoking advocacy message….

This is yet another area of health promotion in which the US has long fallen short. Graphic warning labels on cigarette packs have been used in Canada since 2001, and dozens of other countries have followed suit.

A bit of both, local news that is national  :

Army whistle-blower fights to clear name

Madigan Army Medical Center surgeon Michael Eisenhauer says his military career foundered as he exposed cozy dealings between an Army doctor and a medical-equipment manufacturer. His whistle-blowing helped lead to the criminal conviction of one doctor; but Eisenhauer is still fighting to clear his own name.

Eisenhauer detailed a cozy relationship between the medical-equipment manufacturer Boston Scientific and two Madigan cardiologists, who insisted on sole-source purchases of that company’s implant devices.

<snip>

The long-standing practice of drug companies and medical-equipment manufacturers offering doctors free trips, speaking honorariums and other payments is controversial. Critics say the money may often represent kickbacks for favoring a company’s drugs or devices.

Still, in civilian practices such payments are generally considered legal. In the military, however, doctors are prohibited from taking such payments.

“Military doctors must owe their allegiance to the soldiers and families they treat — not to drug companies or makers of medical devices,” said U.S. Attorney Jenny Durkan in a statement announcing the plea deal reached with Davis.

“That is why we have a bright line rule: doctors employed by the government cannot accept payments or gratuities from an outside source — especially one that is seeking government business.”

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Recent news and commentary of note on US and global issues related to health and well-being:

Medicare Part D Ups Patient Compliance, Reduces Hospital Costs

Why do 70 dead in Norway rank higher than tens of thousands in Somalia?

For-Profit Hospices Keep Patients Longer, Push Costs Up

Where’s the Advocacy, Komen?

Divided Appeals Court Rules That Companies May Patent Breast Cancer Genes, but Invalidates Patents on Comparing the Genes

Big Pharma wants to ‘friend’ you

Drug prices to plummet in wave of expiring patents

Two Steps Forward, One Step Back on Hospital Transparency

The most and least expensive cities for health care

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Can We Afford Personalized Medicine?

Special treatment for ‘high profile’ patients; exasperation for the rest of us

Health Insurers Making Record Profits as Many Postpone Care

People Who Donate Organs For Transplants Can Have Difficulty Getting Insurance

Foundations, Conflicts Of Interest And Drugmakers

Mission Crash: The Intolerable Policy Incoherence in US AIDS Policy, Global and Domestic

 Office of Minority Health Awards Major Project to Support
CCHI’s work on Healthcare Interpreter Certification

WA Governor signs precedent-setting healthcare worker safety laws

Washington is first state in nation to ban toxic pavement sealants

HHS awards $4.9 million to support families of children with special health care needs

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I’m catching up on my reading now, so passing on links to a number of  important studies , some ongoing , published in late 2010, including:

Public Citizen
Pharmaceutical Industry Is Biggest Defrauder of the Federal Government Under the False Claims Act

MSF/Doctors Without Borders
Access to Essential Medicines: Ten Stories That Mattered in 2010

ProPublica
Dollars for Docs: What Drug Companies are Paying Your Doctor

American Medical Students Association
AMSA PharmFree Scorecard 2010 : Conflict of Interest Policies at Academic Medical Centers

and in the news Supreme Court Reviews Data Mining & Free Speech

Also of  note, the upcoming conference of the National Legislative Association for Prescription Drug Prices :NLARx Meeting on Drug Pricing & Affordability, Friday, January 21, 2011, Washington D.C.  


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Beyond the challenges planned to overturn the Affordable Care Act in the US, we need to keep abreast of news  from around the world affecting access to care , such as these headline stories:

HIV Patients May Soon Face a Choice: Full Price Meds or No Meds At All

U.S. Backs Drug Firms in Lawsuit Over Prices

Deadly Spin Strikes a Chord

Firms fight move to obtain cheap anti-blindness drug Avastin

and from North America, illustrating that it’s not only quality control and manufacturing issues, but the profit motive that contributes to shortages of important drugs:

Report warns of medication shortages across Canada

A push to ease prescription drug shortages: Sen. Klobuchar to propose easing imports of medication from abroad

Darcy Malard-Johnson, a pharmacist at the University of Minnesota’s cancer clinic, said 13 of the 150 drugs on the current shortage list are cancer drugs. Most have been around for years, she said, and that may be one of the problems. Because they’re generic, they’re not as profitable to make or sell as newer drugs. And there’s no way of knowing when a company will simply decide to stop making it.

The shortage of oncology drugs in particular was also highlighted in NCI Cancer Bulletin in an article entitled Continued Shortage of Chemotherapy Drugs Causing Concern.

The FDA’s Drug Shortages  website includes current shortages, status updates, and a list of drugs to be  discontinued, per the following terms:

Companies are required under 21 CFR 314.81(b)(3)(iii) to provide FDA with a six month advance notice of the discontinuation of sole source products that are life-supporting, life-sustaining or for use in the prevention of a debilitating disease or condition. From time to time, FDA also receives notification for other products. These discontinuations are provided below for informational purposes only.

Health Canada currently does not conduct such monitoring or provide information on drug shortages, actions that the Canadian Pharmacists Association has urged the government to take on quickly to address the serious and growing problem.

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