China’s Drug Manufacturing Practices Poses Serious Health Risk

China’s unscrupulous drug manufacturing practices pose a serious risk to the Americans.  The fact is that there are increasingly more American drug manufacturers and biotech companies opting to have the drugs and products manufactured oversees.  American drug makers are laying off workers and shutting down manufacturing facilities in favor of moving this part of of their business off shore.  Unfortunately the movement of drug manufacturing out of the United States seriously compromises the health and safety of Americans who may trust that the drugs they take are safe.  As Americans are increasingly forced to take generic drugs without knowledge of where the drug they take is manufactured, the threat to human life becomes greater.  The extent to which quality and standards, such as GMPs are adhered to are much lower in countries such as China.  Recently there has been stories coming out of Puerto Rico as well regarding lack of regulatory oversight.

The FDA is unable to regulate and oversee operations as extensively in foreign markets.  This is something that should be a concern to all American consumers since most all of us are consumers of  medications, if not on a routine basis, at some point or another. The lack of federal regulatory safety oversight and accountability is even more disturbing and potentially life threatening if ones considers that the FDA is having difficulty holding drug manufacturing facilities in the U.S. accountable.  Since Bush has been in office, the FDAs ability to hold drug companies accountable for their practices has been limited and largely ineffectual.  The FDA has insufficient staffing, resources and political mandate to ensure that drug companies are abiding by GMPs (i.e. – Good Manufacturing Practices) as required by law.  The ToyRUs toy recall is nothing compared to the harm posed by drugs coming out of China.

To get a sense of the developments in China relative to drug manufacturing, please read the following article:

From Article, China Sentences Former Drug Official to Death by Kristi Barnes 

The hardline approach may be an attempt by the country to demonstrate to the world its seriousness in stamping out the corruption that is reportedly rife throughout the healthcare and pharmaceutical, among other industries, and has been muddying the country’s reputation, causing it to miss out on billions of dollars of foreign investment. The death penalty was slammed on Zheng Xiaoyu by a Beijing court for taking over $850,000 (€632,000) worth of bribes in the form of cash and gifts. Incidently he also received a sentence of seven years’ imprisonment for dereliction of duty.  In addition, all Zheng’s personal property was confiscated and he was deprived of his political rights for life, according to media reports. His wife and son are also implicated and are still being investigated, among others who are believed to be involved.Zheng, who reigned as China’s chief drug and food official between 1997 and 2006, does, however, still have the right to appeal.According to the court that convicted him, the death sentence was appropriate, given the huge bribes involved and the great damage inflicted on the country and the public by Zheng’s dereliction of duty, it was reported in Xinhua. The degree of Zheng’s corruption is reportedly extensive. According to the court, he “sought benefits” for eight pharmaceutical companies, including the Hainan Kongliyuan Group from South China’s Hainan Province, by inappropriately approving hundreds of drugs and medical devices during a three-year period between 2001 and 2003, six of which proved to be fake.
Dozens of people have been killed by fake and inferior products in China during Zheng’s tenure. In one high profile case in May 2006, nine people died in China after being injected with a concoction of Armillarisni A that contained a fake and toxic ingredient.
In Panama last year, more than 40 people died after taking cough syrup, antihistamine tablets, and calamine lotion which contained glycerine that was contaminated with diethylene glycol (DEG), a poison used in antifreeze and as a solvent. The glycerin was originally sourced from China. Meanwhile, China is also a source of much of the world’s counterfeit drugs – another acute danger to public safety, not to mention the impact on pharma industry revenues.  However, after years of suffering from a bad reputation in the pharmaceutical industry, China is now attempting to reverse the damage. Along with the revenue it has been forgoing, China has realised that without serious change it runs the risk of being usurped by its smaller rival India, and it is desperately trying to clean up its image and attract new international business, and in turn big dollars, into the country. The potential for China’s pharmaceutical market is vast and has been growing rapidly, however, many pharma firms have long been avoiding doing business in the country because of concerns over corruption and the degree of product quality control and regulation, as well as fears of that their intellectual property (IP) cannot be protected.  In addition to the investigation related to Zheng, recent actions from within the country are an indication corruption is beginning to be seriously tackled, and drug manufacturers who produce substandard or counterfeit medicines seriously clamped down on.  The SFDA has just announced it will send 90 officials to carry out drug safety inspections in 15 provinces across the country over the next two weeks.  Last year the SFDA also carried out 35 unannounced inspections of drug manufacturing facilities at the end of September last year and revoked the Good Manufacturing Practice (GMP) certificates of 15 companies and imposed fines, while ordering 13 others to rectify production defects. Commenting on the incident previously, SFDA spokesperson Zhang Jixiang, said that companies should think very seriously and run their business honestly and stick to the law.” He accused local drug authorities of “deficient supervision” and urged them to begin making more unscheduled inspections in order to stamp out the “glaring problems” among China’s drug manufacturers. 

If you are concerned about this real health threat and want to take action, I encourage you to visit the website “Public Citizen” http://www.citizen.org/ to find out more and find out how to become an activist for reform.  The People’s Pharamacy is also a good source of information about drugs.

We need to be the instrument of change that we want to see in society.

Oscillococcinum is a Whole Foods Scam – Don’t Buy!

On my purchase of Oscillococcinum at Whole Foods – Buyer Beware:

Okay.  I admit it. I got fooled by the marketing pitch by the good folks at Whole Foods. Not long ago I was shopping at Whole Food while the whole family was home sick with the flu. Although I knew there was not much I could do to alleviate their suffering, except to encourage them to rest and drink plenty of fluids, I wanted to feel I had the power to do something. I was enticed by the bright orange and yellow Oscillococcinum box prominently displayed at the checkout counter. Each time I shop at Whole Foods I see it as I check out. Each time I see it, I wonder, what is this stuff and could it really help with flu symptoms. After all, the box states that it is the #1 flu remedy. Although pricey at $12.99 a box for six doses, I decided to purchase Oscillococcinum and give it a try. It couldn’t possibly hurt. Could it?

I was able to convince various family members to throw skepticism out the window and to swallow the “mysterious powder” in the vial, but not without some resistance. They asked “what is this stuff?” “what is it suppose to do?”. Legitimate questions I suppose, given I had convinced them to take a medicinal product I and they knew nothing about.

Since I could not answer these questions, I did some research on the web to find out more – what exactly is Oscillococcinum – the #1 flu remedy in France ?  The package lists as it’s active ingredient anas barbariae hepatis et cordis extractum.  I discovered that anas barbariae hepatis is a substance produced from the heart and liver of a domesticated fowl that French cooks use to make a duck dish.  It has no scientifically proven medical benefit. But it gets better. And at this point I felt like a complete fool for buying the product. I didn’t actually buy the actual duck heart and liver, I bought six sugar pills soaked in water that was derived through a process of dillusion of the duck heart/liver junk…( this is the best I can explain it – but there’s a more scientific explanation of the process if you’re interested at the website).

#1 flu remedy in French. Doesn’t say too much for the intelligence of the French people. (I had to laugh since my dear arrogant French friend who is constantly lamenting Americans lack of sophistication and intelligence.) You mean the French, the morally and intellectually superior people that they are, are actually stupid enough to believe that this sugar pill works? As I discovered, most of today’s doctors discount the remedy as implausible; with some even using the word “fraud”.  At $14 for six doses, that’s quite a fraud that’s being perpetuated on the American consumer.

If you have been duped by this scam, please let Whole Foods know. It is unethical for Whole Foods to so aggressively promote a product which clearly has no scientifically proven health benefit. To lesson learned, don’t trust Whole Foods or any retailer for that matter who sells a product in the name of health without sufficiently researching the product first. BTW: a clerk in their health section actually encouraged me to buy the product – clearily unethical.

Please see the following website for more information on the Oscillococcinum scam along with scientific explanation of the product:  http://www.homeowatch.org/history/oscillo.html

Muse or Ruse?

Article from Psychology Today by Carlin Flora, December 2003

Our culture romanticizes the myth of artistic inspiration, perhaps because we’d like to think that some people have artistic gifts, and that great literature or beautiful music is more a question of luck than hard work. Why do we cling to the myth of the muse?

In the film Girl with a Pearl Earring, Scarlett Johansson plays a young maid whose tender good looks ignite passions—and inspiration—in the 17th century painter Johannes Vermeer. It’s not the first time muses have provided fodder for film: Albert Brooks’ movie The Muse stars Sharon Stone as a bejeweled, high-maintenance cure for writer’s block.  Our culture romanticizes the myth of artistic inspiration, perhaps because we’d like to think that some people have artistic gifts, and that great literature or beautiful music is more a question of luck than hard work or struggle. “It’s easier to believe that it just happens,” says Michele Root-Bernstein, co-author with husband Robert Root-Bernstein of Sparks of Genius, a book about creativity.  Something unexplainable and mysterious does occur during the creative process, agrees Root-Bernstein, but only if the creator has both talent and technique, and, most important, is working hard. “You have to continually pull things together and imagine things,” she says. “When these ideas start clicking, that’s inspiration.” 

But if feelings and thoughts are inseparable, as the Root-Bernsteins argue, then emotions must be part of the creative stew. Love can stir up complex feelings, leaving the artist aching to express new ideas, theorizes Francine Prose in her 2002 book The Lives of the Muses.   Active love can fuel the imagination, but an unattainable muse can also do the trick: “Unrequited love may be the metaphor for the making of art, for the fact that a finished work so rarely equals the initial impulse or conception, thus compelling the artist to start over and try again,” Prose writes.  Certain artists buy into and perpetuate the muse mystique.  A young guitarist who fancies himself a tortured type may seek out a vulnerable woman to play his muse.   As long as the relationship stays stormy, he will feel the rage and ardor that bolster his identity.  Many artists rely more on a supportive mentor or spouse. “Creative individuals need cognitive and affective support during the time of their breakthroughs,” says Howard Gardner, psychologist and author of Creating Minds. Martha Graham got both from Louis Horst, he adds, while Freud had cognitive support from Joseph Breuer and Wilhelm Fliess along with affective support from his wife and sister-in-law. Sometimes spouse and muse fuse: The dozens of paintings of Pierre Bonnard’s wife Marthe in the bathtub are a testament to his obsession with his amphibious love.  But support and inspiration are not the same thing. “If a scientist has a supportive wife who allows him to concentrate on his work,” Root-Bernstein says, “she’s absolutely necessary to the creation; she’s complicit in it, but she’s not a muse.” Prose quotes the writer Robert Graves, who wrote: “the domestication of the muse can actually destroy the poet’s talent.”That Girl with a Pearl Earring is set in the 17th century is no coincidence; the muse reflects an outdated idea of womanhood, when women were valued more for being than for doing. Prose comes up with one example of a “male muse”—Denys Finch Hatton inspired his lover, Isak Dinesan, to write Out of Africa, by listening raptly to her stories when he visited her in Kenya. Switching gender roles may allow the muse-artist relationship to flourish as women become more prominent in the arts and sciences. Or a more symbiotic version might develop, a la Yoko Ono and John Lennon.  The muse, a beloved symbol in great art, can be counted on to sell a book or movie. But she’s otherwise flighty. “If the writer doesn’t sit at the computer every day,” Root-Bernstein warns, “the muse is not going to visit.”