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Archive for the ‘FDA’ Category

A Honey of a Translation

Posted in Consumer Protection, Environmental Health, Ethics, FDA, Global Health, Health Care Marketing, Hispanic/Latino, Language Services, Paitent safety, Patient Safety, Promotions, Translation on 9 December 2013| 3 Comments »

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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US Patient Petition Calling for Reduction of Gleevec Price

Posted in Access to Medicines, Cancer, Economics of Health Care, Ethics, FDA, Generics, Global Health, Health Care Marketing, Health Insurance, Healthcare Inequalities, Lobbying, Prescription drugs, Promotions on 9 May 2012| 1 Comment »

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 History.  The 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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