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Archive for the ‘Promotions’ Category

Exciting news came at the end of the year for Gary Schwitzer’s Health News Review project which had lost the funding that supported the team of reviewers that analyzed the accuracy of health stories in the news and published their findings. HNR was awarded a two-year, $1.3 million grant from the Laura and John Arnold Foundation to continue and expand its work, which will now be housed in the new Center for Media Communication and Health in the U of Minnesota School of Public Health.

I’ll be looking forward to more important stories coming our way soon to share here.  And all of us can hone our critical thinking skills on health news stories by applying the HNR  framework anytime:

What’s the total cost?
How often do benefits occur?HealthNewsReview
How often do harms occur?
How strong is the evidence?
Is this condition exaggerated?
Are there alternative options?
Is this really a new approach?
Is it available to me?
Who’s promoting this?
Do they have a conflict of interest?

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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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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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The article Efforts to Undermine Public Health:  Health Advocacy Organizations and the Pharmaceutical Industry: An Analysis of Disclosure Practices in the Jan.13 issue of  American Journal of Public Health focuses some much-needed attention on a serious and growing problem , which directly impacts the creation of rational health policy.  It’s also good to see the wide media attention being given to the study, which has been flagged by venues across the spectrum, including  healthcare sector analysis and investigative reporting blogs to mainstream  business media and news reports.

It’s been interesting too,but not surprising to see, that a number of people are also sending identical comments to multiple venues  which covered the story, some to decry the findings of the study, or  to make  off-topic remarks. The comments from the National Health Council , for example emphasized that it has a policy of requiring member groups to have internal disclosure policies regarding industry support received. The NHC itself  has a listing of funding received in 2009 from its  many “Corporate Partners.”   However, just like with payments to physicians, merely acknowledging industry funding doesn’t mean that it does not influence the actions of the recipient, nor not create conflicts of interest.  Unlike the significant body of research on the topic of influences on the prescribing practices of doctors (which have found that while many  state that they themselves are not influenced by pharma gifts and perks, they believe that their colleagues are) , much less attention has been paid in the US to the phenomenon of  industry support of HAGs and its impact on public policy.

Based on personal observations both as  patient and a healthcare professional , I believe that the “don’t bite the hand that feeds you”  phenomenon  relating to HAGs, contributes to  the present inaction on getting states and federal government to do something about the exorbitant and escalating price of medicines as a public health measure. Until the electorate actively protests what is going on, the lobbying power of the biopharma industry  on Congress will remain in effect. While it is becoming more common to find  media pieces highlighting  complaints by provider and  disease groups  about the price of Rx drugs, along with the unaffordable co-pays for those insured, almost never do we hear patient advocacy groups demand that something be done about the situation.  The only logical conclusions that seemingly can be made about the scenario is either that the public is incredibility naive about how the pharmaceutical  and insurance  industries  function, or else HAGs have been so influenced by their pharma benefactors that recipients actually believe that the prices are justified by R & D costs, and that patient assistance programs ( PAPs) are a genuine access solution.  Likely it’s some combination of factors.  More about this later.

Since a requirement that  HAGs disclose industry funding was dropped from Sunshine Act provisions incorporated in the ACA, it’s time start to address the problem by pressing the IRS to require that all 501(c)3 charities disclose their funders and amounts received from each. At the same time, much more public education  is needed about  “the ties that bind”, to paraphrase the title of a 1999  report on the topic  by Health Action International.

In the meantime, those interested in starting to research  industry links to patient and disease groups will find the following resources of independent organizations helpful:

Essential Action
Pharmafiles database: Patient and Health Groups and Their Corporate Funders
Patients, Patents and the Pharmaceutical Industry

Knowledge Ecology International
Medical professional and patient group funding by drug and medical device companies

Healthy Skepticism


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The first international  “Selling Sickness” Conference held October 7-8 in Amsterdam drew some 200 participants from around the globe to discuss the issues and trends in marketing of prescription drugs. While most attendees were from Europe, all regions of the world were represented at the event. Slide shows of the presentations, along with a list of attendees, may be viewed on the conference website.

Many of  conference presentations  focused on the  phenomena and techniques of  promotion of “disease mongering”: use of pharma promotions to depict normal life issues as diseases and to encourage consumers to visit doctors to seek prescriptions to treat these disorders.  My poster displayed at the conference focused on a different facet of inappropriate drug promotion, the equally problematic practice of misleading promotion of a very useful new drug for genuine and deadly diseases. The poster Glivec in Global Perspective, covers highlights of the worldwide promotions for the breakthrough cancer drug Glivec, done for a different purpose. Since Glivec is quite effective for most patients for whom it is indicated, its manufacturer Novartis has used promotions to aim to secure both its excessive global price and monopoly patent status for the drug.

Novartis, a relatively new company on the scene, formed from the  merger of Ciba-Geigy and Sandoz  in 1996, has invested heavily in patient relationship marketing to further its goals. Influencing patient groups by all the well-known techniques used to woo doctors to prescribe certain medicines–along with patient-specific types of outreach–has been used to induce enthusiastic lobbying for Glivec, and ostensibly to keep patients from recognizing and protesting the real cause behind access problems for this drug, its exorbitant price. Novartis has not hesitated to approach cancer groups, and to help create new ones, through emotional manipulation of the genuine despair  linked to the diseases and the experiences of patients with health systems. Yet most patients continue to seem to be unaware of  what is really going on, showing the power of the promotions. This poster was created as an educational resource on drug promotion as a critical public health issue. While no health system, insurer, government, or individual has unlimited resources, the vast majority of patient groups lobbying for access to Glivec, along with other costly drugs, act as if cost were irrelevant. Unless things change, access to this and other important medicines is only going to get worse. Those of us with both personal and professional experience in this realm can play an important role in spreading the sunshine on this vital topic. Supporting information and references were too lengthy to include in the poster, so have been organized as a separate document.

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