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Archive for the ‘Ethics’ Category

Old US Public Health Service Hospital (known as Pacific Tower during its tenure as Amazon HQ building) to become new satellite campus for allied health professions programs of Seattle Central Community College and serve as site for public agencies and NGOs. AmazonBeaconHillHQ*304

Seattleite Jeanne Sather, author of Assertive Cancer patient  blog ,died from metastatic breast cancer  15 years after her original diagnosis

In June the King County Board of Health unanimously approved creation of drug take-back system for county residents , to be financed by a 2-cent per Rx tax. On Dec. 1, PhRMA filed a lawsuit against King County , claiming that the plan causes a financial burden for patients and that in-home disposal of  medicines is the best way to keep Rx drugs out of the wrong hands.

State to review hospital affiliations — Catholic and otherwise

Public hospital CEO gets pay cut to $1 M per year, at Renton’s Valley Medical Center

Harborview to close  pediatrics, women’s, & family clinics

Health Care Reform for American Indians and Alaska Natives 2013  including WA-specific page

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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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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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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

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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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Recent developments in Washington and neighboring Oregon are reminders of the clout and lobbying power of Big Pharma on the local level.

Seattle City Councilmember Tom Rasmussen announced that he was working to implement a  discounted prescription drug program for Seattlites , a program of the National League of Cities.  At first glance this might seem like a boon most of us, cash-strapped and increasingly uninsured and underinsured, but in reality the plan is not needed, won’t offer much in the way of bargains, and is linked to a questionable PBM. With all due respect to Rasmussen, who undoubtedly has good intentions , he seems unaware that we already have a drug discount program available at no charge to all state residents, the Washington Prescription Drug Program , which offers discounts up to 60% on generics and 20% on branded drugs, while the NLC program  offers maximum discounts up to 23% of full retail prices.  Another concern is that the NLC card is an offering of CVS Caremark, the mega-PBM which has earned itself notoriety for  unethical business practices, including overcharging government employee health plans ( including the federal plan) for Rx medicines and drug-switching on scripts. The Seattle-only program is due to start next month, so now is a good time to weigh in with Rasmussen and his fellow City Councilmembers , as well as with Mayor Mike McGinn on the issue.  In addition to helping to increase awareness of the WPDP, our city elected officials could really offer a public service by creating a drug price comparison tool that surveys Seattle pharmacies.

And in the Washington Legislature, among several bills dealing with prescription drugs ( look for my comments in the future), for the third year in a row we saw  Drug Companies Fight Take-Back Program for Unused Medicine. They claim that take-back programs, which they would be required to help pay for, would do little to stop  abuse of prescription drugs and that environmental concerns about trashing meds are essentially bogus. Take Back Your Meds, a group of over 260 health organizations, police, drugstores, local governments, environmental groups and concerned individuals vows to keep up the fight.

In Oregon, a legislative defeat with direct negative impact there and for partner WA in the Northwest  Drug Purchasing Consortium , pharma and insurance industry muscle united to make sure that  Oregon Prescription Drug Program Bill Dies a Second Death. SB 1577 would have required all state agencies to purchase medicines for beneficiaries through the Oregon Prescription Drug Program, reversing the current optional  status.  When the OPDP and the WPDP were created in 2005, they formed the Northwest Prescription Drug Purchasing Consortium to achieve better prices through pooled volume purchasing but left participation optional for state agencies. In both states, for example,  the Dept. of Corrections does not participate.  And with efforts to control Rx costs stymied, we are seeing scenarios such as this year’s state budget proposal in Washington to eliminate completely prescription drug coverage for adults in the Medicaid program, only now with some hope of possible mitigation if competitive bidding for generic drugs is approved by the Legislature now in Special Session.

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With almost nothing but a steady stream of dire news about public services in 2011 , and  the prospect of even more budget cuts facing us as the Washington State Legislature convenes work today, it is heartening to hear some good news. For the third year in a row, Washington has earned bonuses for enrolling children in Apple Health for Kids, our state’s plan for low- and middle-income kids, which includes the Children’s Health Insurance Program. As Crosscut reported:

Tens of thousands more children have health insurance now, despite the state’s having reached the grim milestone of 1 million uninsured residents last year. Washington is also the only Western state to win federal awards in 2011 for both early learning and children’s insurance programs.

Of course, one of the reasons that so many children are now enrolled in Apple Health is because their parents have lost their jobs and/or health insurance. And some 100,000 eligible children are not enrolled in the program, highlighting the need to continue outreach efforts, which lost  state funding in 2009.  Nevertheless the ceaseless efforts of advocacy groups like  the Children’s Alliance are a driving force which led to this performance award, which  in turn will help the State do even more for our kids.

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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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Kudos to Insurance Commissioner Mike Kreidler, who took action on behalf of consumers!   From the OIC  blog:

Health insurance rate requests now public

Individual and small employer health insurance rate requests are now public. See the complete filings received since July 1, as well as a summary for each request.

Several health insurers filed rate requests prior to July 1, but have voluntarily made their filings public. They include: Asuris Northwest Health, Kaiser Foundation Health Plan, and Regence BlueShield.

Insurance Commissioner Mike Kreidler proposed the legislation (HB 1220) making health rates public on behalf of the consumers who contact his office, demanding to know what’s driving their higher premiums. State law prevented him from sharing the information that insurers use to justify rate requests – even after the rate was approved.

The new law makes most individual and small employer health insurance rate filings public shortly after they’re received. This includes how much of the requested rate will be spent on medical claims, administrative costs and profit. Also, the public will see if their rate change includes any benefit changes.

Kreidler’s office is building an interactive web tool where the public can search rate requests, post comments, and sign-up to get an e-mail when their health plan requests a change and a decision is made. The new tool is scheduled to go live early this fall.

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