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Archive for the ‘Consumer Protection’ 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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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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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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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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Now more so that ever, learning of positive developments and new efforts of those working to make a difference, helps me to keep going . I share here with you some news of significance at the local, state,  and national levels.

In Washington State:

State lifts three-visit ER limit for poor patients

Workers’ wellness saving jobs in parks, policing, transit

Poor people win: Judge allows 11,000 to rejoin Basic Health

In New York State:

Medicaid team passes four sets of reform proposals, including Safe Rx  to “Promote Language Accessible Prescriptions”

Governor Cuomo Issues Executive Order to Improve Access to State Services for Non-English Speakers

Nationally:

One Million Young Adults Gain Health Insurance in 2011 Because of the Affordable Care Act

For kids in foster care, law now requires that states create protocols and actively monitor the use of psychotropic medications

Launch of Pharmacists United for Truth and Transparency

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I just learned that October is Health Literacy Month, via an article entitled  “Hospital discharge summaries are a health literacy issue” (a guest post by another physician) published on the KevinMD.com  blog.

(Background: this article had originally been posted on another blog called Engaging the Patient, sponsored by  Emmi Solutions, a healthcare communications firm which is promoting Health Literacy  Month.) 

The first paragraph described a patient as being a very elderly Filipino woman, and the article went on to explain how she had suffered some serious adverse effects because there was  a problem with how her Rx medicines had been prescribed.  Turned out that two of her meds had been combined into a single pill, a fact that was not apparent from the patient’s medication list.

But I was left wondering why the patient’s ethnicity was mentioned at all, since there was no discussion of any relevance to her health issues nor about if she had limited English skills, which also does not automatically track with ethnicity.  So I was surprised to read the following conclusion to the case study:

My hope is that this case illustrates the ways in which we might address health literacy issues using fail-proof systems-based approaches, rather than narrowly focusing our efforts on how we can build our patients’ capacity to interact with the health care system. Yes, teaching this patient to be a more fluent reader and to understand her prescription labels would have been ideal.

And we should have taught her to be more engaged and given her a phone number that she could call post-hospitalization to reach a Tagalog-speaking provider with questions about her discharge instructions or medications. But while we are working on engaging her with her care and teaching her to read prescription labels and providing enhanced communication support, let’s do what we can to “fix” the health literacy problem without involving Ms. Reyes at all.

Somehow the author made a non sequitur jump to depict the patient as  Limited English Proficient (LEP), but never once spoke of utilizing the services of  an interpreter at the hospital or if any  instructions had been translated for the patient.  It was likewise not mentioned that a pharmacist could have played an important role in the case. Seemingly this young physician knew nothing of the duties of the hospital to ensure communication between providers and patients, and is disseminating this scenario as typical.

So a response was in order.  I’m happy to say that my comments on the article were accepted for posting, and hope they will help make a dent.

My message for Health Literacy Month is that we need to seize the teachable moments.

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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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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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