The Health Spot

…to none other than the Big Pharma team Elli Lilly. rBST is recombinant bovine growth hormone, a synthetic hormone (a replication of bST) injected into cattle to produce milk, a protein hormone produced in the cattle. Monsanto was just getting to bad of a rap with the the hormone, I guess. But I can’t imagine how Elli Lilly will help it any. They’re already getting their ethics and attempted cover-ups of marketing fraud and potential health risks - like the 2006-2007 case of the the company’s antidepressant Zyprexa and its connection to the death of young boy. The organization MindFreedom, a mental health human rights group, kept a document of the The New Times articles.

Why would Monsanto sell rBST?

Maybe because it has been giving the company a bad rap because of its horrible effects on animals and, well, Elli Lilly has a team of marketing giants that ain’t to be reckoned with (I guess the PR bit about rBST slowing global warming didn’t pan out…).

I guess we’ll just have to wait and see, right?

Got rBST?

A recent study from Cornell University is claiming that rBST can slow down the global warming process. What is rBST? It’s recombinant Bovine Somatotropin, a synthetic hormone injected into cows to increase milk production. The hormone mimics Bovine somatotropin, a naturally occurring protein hormone produced in the pituitary glands of cattle.

The Cornell study, published in March 2008, reported that “From an industry perspective, supplementing one million cows with rbST reduced feedstuff and water use, cropland area, N and P excretion, greenhouse gas emissions, and fossil fuel use compared with an equivalent milk production from unsupplemented cows.”

The study indicated that supplementing one million lactating cows with rBST would save 2.3 million metric tons of feed and 540, 000 acres of land. In 2006, the United Nations Food and Agriculture Organization reported that livestock creates 18 percent more greenhouse gas emissions than transport and that livestock was also a huge source of land and water degradation.

So rBST is the green way to go, right?

Maybe. Maybe not. The study was not exclusively conducted by Cornell University - Monsanto Company Animal Agricultural Group, the primary producer of rBST (under the brand name POSILAC), was a part of the study. Furthermore, of the four scientists conducting the study, two had strong ties with Monsanto company. Roger Cady is the rBST technical project manager at Monsanto and Dan Bauman was paid consultant for Monsanto.

The scientists who conducted the study claim that their close ties with Monsanto and Monsanto’s role in the scientific study did not affect the outcomes of the study.

But many are skeptical of the synthentic hormone. In most European countries, as well as in Canada, Australia and New Zealand, rBST has been deemed illegal and inhumane. The European Union stated that rBST increased health problems with cows, including mastitis, foot problems, and reproductive problems.

But despite international rejection of the hormone and objections from groups like the Consumers Union and the Cancer Prevention Coalition, the FDA approved the hormone for human use in 1993. Still, more and more companies - including big corporations like Wal-Mart, Kraft, and Safeway are refusing to use the hormone in their products. Monsanto’s response is taking legal action against dairy producers who mark that their products do not contain rBST.

Why? Because stating that a product doesn’t use an ingredient assumes that the ingredient is unsafe.

Two ex-Fox News producers, Steve Wilson and Jane Akre, believe that the hormone is unsafe.

In the mid-90’s Wilson and Akre were fired from Fox News station for attempting to reveal data about the potential side effect of the growth hormone rBST. Health Consultant Jonathan Campbell has details about the case on his website. To sum it up, Monsato, the largest manufacturer of the hormone, submitted there own statistics to Fox and told them to run it. Fox agreed. Wilson and Akre refused and took the report to the FCC. Ultimately, Fox won the battle on an appeal.

I recently wrote a blog for the San Francisco PBS affiliate KQED’s Quest, an environment and science program. Here’s a link to the blog, and the actual blog post below:

Humans produce 500 billion plastic bags annually.

In China, they recently banned it. Australia, Bangladesh, Ireland, Italy, South Africa,Taiwan, Mumbai and India have either banned it or discouraged its use by raising taxes. And on March 27, 2007, San Francisco became the first city in the USA to ban it from large grocery stores.

More people are ditching plastic bags on a local and national level with good reason: we produce about 500 billion plastic bags world-wide, and less than one percent of that is recycled.

A recent QUEST report shows that plastic bottles are straining our environment, too: each year the USA alone produces 50 billion plastic bottles. Some would say to switch from plastic to paper bags - but reports show that paper bags aren’t the most sustainable solution.

Plastic can have a longer shelf-live than humans do: it can persist in the environment for anywhere between 20 to 1,000 years. But a 16-year-old from Waterloo, Canada figured out to decompose it in only six weeks.

Daniel Burd, a student at Waterloo Collegiate Institute, discovered the key to decomposing plastic bags for a school science fair. Needless to say, he won.

“Almost every week I have to do chores and when I open the closet door, I have this avalanche of plastic bags falling on top of me,” said Burd to The Record, a Waterloo newspaper. “One day, I got tired of it and wanted to know what other people are doing with these plastic bags.”

First, Burd decided to isolate the microbes that break down plastic in polyethelene plastic bags. Burd ground plastic bags into powder and created a solution to break it down using tap water and yeast. Six weeks later, he found that the plastic weighed 17 percent less than the control group.

Burd then isolated the effective strains that caused the degradation - Sphingomonas and Pseudomonas - and tried the experiment again, adding sodium acecate.

Six weeks later - as opposed to 1,000 years - the plastic decomposed by 43 percent.

For his final report, Plastic Not Fantastic, Burd wrote that his process of polyethylene degradation can be used for large-scale plastic bag biodegradation.

“As a result, this would save the lives of millions of wildlife species and save space in landfills,” wrote Burd.

Tipu’s Tiger Chai Inc, of Missoula, Montana just recalled all of its Tipu’s Tiger Chai Concentrate because the tea can potentially be contaminated with a life-threatening bacterium called Clostridium botulinum. If ingested the bacterium can lead to a grave paralytic illness caused by a nerve toxin. Consumers are warned not to use the product.

Funny enough, purified botulism toxin is used as medicine (and the it’s first bacterial toxin to be used as such). The FDA approved botulism for medical use in 1989 to treat eye conditions. Today, the drug is more widely known to be injected into people lips to give them that sensual, take-me-right-now look.

Yes folks, it’s Botox.

This past February, however, the FDA notified the public (aka put a press release on their website…) that Botox has been linked to “adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses.”

The FDA decided not to warn doctors against the drug, however.

I mean, a little respiratory failure or death isn’t that bad, right?

“The Declaration of Geneva of the World Medical Association binds the physician with the words, ‘The health of my patient will be my first consideration,’ and the International Code of Medical Ethics declares that, ‘A physician shall act only in the patient’s interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient.”

Those are the words of the Declaration of Helensinki, the most authoritative international document giving ethical guidelines on medical research on human subjects.

And the FDA just decided to dropped it for their overseas clinical trials in developing countries, choosing a set of more ethically lax guidelines instead (Guidelines for Good Clinical Practice) that will go into effect in October.

This is fabulous news for big pharmaceutical companies: they will save big bucks on clinical trials by by not having to follow some of the invaluable health and safety codes highlighted in the Declaration of Helensinski. Drugs companies typically try to get their drugs on the market as fast as they can: new drugs get a 20 year patent (with exclusive selling rights) that begins before clinical testing on humans. So the sooner the drugs get in the market, the sooner they cash in. Hence more lax guidelines.

Pharmaceutical companies have been moving their outsourcing of clinical trials on humans over to developing countries for more than four years now - and started advocating for the FDA to scrap the declaration overseas ever since. The cost of the clinical trials can be up to 60 percent lower in developing countries - many of which don’t have ethical guidelines for clinical trial that compare to those of the FDA’s guideline here in the US.

Many big pharmaceutical companies in developing countries (including the US companies Pfizer and Eli Lilly) have repeatedly done actions that are against the Declaration of Helensinki. A group called WEMOS did and extensive study called, titled “Bitter Pill,”citing 22 different case of unethical clinical trials there were directly against the declaration.

But now (due to lobbying by you-know-who) the FDA decided to no longer abide by this international law that dates back to 1947.

If you suffer from sleepless nights, you don’t always need prescription - or non-prescription - drugs to go to sleep at night. There are a lot of age-old and very natural remedies to help you sleep and relax (relaxing, as you know, helps you get to sleep).

Rose oil and rose petal are used by many cultures to relax. Using fresh or dried rose leaves in a hot bath, or using drops of essential (non-alcohol based) rose oil before bed, can help your nerves relax and get you to sleep.

Chamomile is also a wonderful method to relax the nerves. The National Institute of Health notes that chamomile tea or extracts or often used for sleeplessness. The NIH site “Herbs At A Glance” also has a list of other herbs used for medicinal purposes.

Another natural remedies for insomnia is Valerian root. The NIH writes that Valerian root in pill form is often used for various sleep disorders.

Often sleeplessness is caused from stress or an over-active mind. It’s worth trying out natural remedies before turning to drugs that have really serious side effects.

Homemade spoofs making fun of Big Pharma commercials all over Youtube - even Saturday Night Live has jumped on the bandwagon, making a spoof on birth control pill commercials. According to a 2006 survey by Consumer Report’s National Survey Research Center, 78 percent of doctors say that patients ask for drugs after seeing commercials for it on television.

Click here to check out what I think is the funniest spoof on the Lunesta.

Now people are even creating mock drug website. On the ‘Panexa’ website, the comical conditions for use include “digestion (solid and liquid), circulation, menstruation, cognition, osculation, and extremes of emotion.” A new ailment was even created for the fake drug Havidol: Dysphoric Social Attention Consumption Deficit Anxiety Disorder, also known as DSACDAD.

But the advertising giants that spend all those millions on the real Lunesta commercials are making their way into Youtube too, via a company called Illumistream that is own by FullTurn Media.

Check out this video, which has a medical ‘professional’ touting the medicinal benefits Lunesta. Seems relatively normal at first. Illumistream’s Youtube homepage suggests that they are a safe, non-partisan source:

“Everyone has trouble sorting through that complex medical jargon to get to the facts!,” the site reads. “That’s where we come in. illumistream makes fun-to-watch, easy-to-understand healthcare videos. No runaround. No HMO. No waiting room. Period.”

Sounds harmless enough. But now check out Illumistream’s website, which reads: “Compelling video content that makes publishers and advertisers look great!”

Yes, like the advertisers for Lunesta. Thanks Illumistream, for helping me sort through all that medical jargon.

Sepracor, Lunesta’s mother-company, spends millions on advertising for Lunesta. According to the March 2008 issue of DTC Perspectives magazine (which gets data from the media research company Nielsen Monitor-Plus), Sepracor spent $246.4 million on Lunesta direct-to-consumer ads between January-September 2007.

But the add agency that brought you that strange, luminescent moth, McCann HumanCare, soon will no longer be Lunesta’s advertiser. Seprecor hired Kaplan Thaler (the folks that brought you commercials of Dr. Robert Jarvik’s touting Lipitor) in hopes of further increasing sales.

Why? John Mack writes in his blog, Pharma Marketing, that the total budget for marketing Lunesta may cost around $81 million a month, while monthly sales are much lower. Not a pretty picture for stock holders. So whats their answer? Change advertising companies to the company that brought you Lipitor commercials.

It worked for Lipitor. Until the commercial got banned, of course.

So buy Lunesta - stock holders are counting on you!

Dark sarcasm aside, Seprecor is acting pretty shady about their spending these days. Under the ‘For Investors’ link, a preview before an obscure report reading ‘Gaining Momentum’ reads:

“Based on initial results from an internal review of the Company’s government price reporting, the Company has concluded that it will likely need to restate its financial statements for the quarters ended March 31, June 30 and September 30, 2007 and 2006 and the fiscal years ended December 31, 2006, 2005, 2004, 2003 and 2002. Accordingly, you should not rely on any of the financial information provided on this web site.”

So why do these guys still have links for financial reports that they say are faulty? They don’t even provide a reference to the financial disclaimer on the first page of the investors portion of the website. But then again, these folks spend over $80 million a month for marketing on Lunesta alone - they know about what should and shouldn’t be advertised.

It’s 12:56 am and I’m watching the Late Late Show with Craig Furgeson (the Late Night Show with David Letterman just ended, and this came on next) on WNBC. I have a full day - and night - ahead of me tomorrow and I should probably be asleep right now.

Wait. What’s this? A commercial just came on it’s telling me that heck, I should be sleeping and there is something out there can help me: Lunesta. “A great tomorrow starts tonight,” the add informs me.

The narrator’s soothing voice warns me, “Until you know how you’ll react to Lunesta, you should not drive or operate machinery. Do not take Lunesta with alcohol. Most sleep medicines include some risk of dependency. Side effects may include unpleasant taste, headaches, drowsiness or dizziness.”

While talking about potential side-effects, the video shows a woman sleeping soundly with a warm smile on her face (I guess she didn’t get a headache) - so its rather easy to miss the commercial’s short warning about the side-effects. A common marketing tactic for Big Pharma.

There is a link to the Lunesta commercial on their website, but it won’t open in Firefox, Safari or my Internet Explorer browser. The link to the 7-day free trial does work, however. How convenient.

The add claims people now sleep better and longer - between 7-8 hours - because of Lunesta. The statement comes from the 2003 study of Lunesta which subsequently led to FDA approval of the drug in 2005.

But according to a study by Lisa Schwartz, professor of medicine at Dartmouth, Lunesta doesn’t offer much more sleep. An article in NPR’s website states that Schwartz found that “the volunteers in the study who took Lunesta slept on average 6 hours and 22 minutes per night. This compares with those who took a placebo, or sugar pill. They slept an average of 5 hours and 45 minutes.”

The difference in sleep was only 40 minutes.

So what exactly is Lunesta? And is it worth taking for that extra 40 minutes of sleep?

Lunesta (eszopiclone ) is a nonbenzodiazepine hypnotic agent approved for the long term treatment of insomnia and sleep maintenance.

In his book, The Dark Side of Sleeping Pills, Daniel Kripke, MD, said that FDA studies show evidence that new drugs like Lunesta cause cancer in rodents.

“To my great surprise,” wrote Kripke. “I learned that rats and mice given high doses of zaleplon (Sonata), eszopiclone (Lunesta) as part of zopiclone, and ramelteon (Rozerem) developed cancer. These drugs also broke chromosomes, which is a well-known specific chemical mechanism by which drugs cause cancer.”

Kripke said the evidence was confusing - and probably deliberately so. He added that a study amongst humans taking the new sleeping pills show that “There were 8 new skin cancers among study participants randomized to the sleeping pills and no new cancers among those who only received placebo.”

Makes you think that maybe Lunesta isn’t what you need for ‘a great tomorrow’.