A jury in Oregon state court delivered a verdict of $5.5 million against I-Flow Corporation for causing devastating, permanent injuries to Matthew Beale by promoting the use of I-Flow pain pumps in joints.

The pain pumps, like those used on Mr. Beale, were promoted by manufacturers including Breg, Stryker, McKinley and I-Flow to physicians for use after joint surgeries.  The theory was insertion of a delivery system that would place pain medicine at the area of surgery would allow for greater pain relief for shoulder, knee and other joint surgery patients.

As with drugs and other medical devices, the theory sounded very good, but, as the FDA told manufacturers, testing would be required in order to safely market the devices for placement in the joints.

Pain pump manufacturers ignored the FDA by conforming labels to FDA requirements and then sending their marketing force out to promote the off label use inside joints. So, sales forces were sent out by each manufacturer in a frenzied effort by each to gain market share. What the manufacturers did not do is any meaningful studies on the results of injecting pain medicine directly into patient joints.

Effectively what pain manufacturers decided is to allow the public to be the guinea pigs for testing and not to tell physicians the pumps had not been approved for in joint placement.

When manufacturers were caught and it was clear their untested devices were causing devastating injuries to young, active people, they were slow to pull the devices or to alert physicians. Instead, they spent their energies trying to find ways to bury discredit the findings. Finally, as the result of lawsuits, they were forced to alert physicians and to withdraw their devices from use inside joints.

Sadly, the pain pump manufacturers’ decision to discourage the unapproved use they had previously promoted was far too late for hundreds, perhaps thousands, of innocent victims.

Now, relatively young people in the age group of 20 to 55 will be forced to undergo multiple surgeries in attempts to correct the devastating damage done by the unapproved use of the pain pumps. Many patients will be forced to experience full joint replacements and, because of their young ages, possibly one, two or three additional joint replacements or revision surgeries during their life will be required.

It seems pretty clear to any informed person that chondrolysis, a relatively rare condition before pain pump use was promoted, has now resulted in significant increases in damaged cartilage. Chondrolysis is a condition in which the cartilage is essentially destroyed and the patient is left with no protection inside the joint. In plain terms, imagine pouring battery acid on the cartilage inside a patient’s joint and you have the damage caused by pain pumps inserted inside the joint. The results are severely damaged joints and hundreds of thousands of dollars in medical care.

According to World Health Organization (WHO) there are one billion overweight adults worldwide and 300 million are categorized as obese. The World Health Organization cited several contributing factors among which are:

“increased consumption of energy-dense foods high in saturated fats and sugars, and reduced physical activity, Economic growth, modernization, urbanization and globalization of food markets are just some of the forces thought to underlie the epidemic.“

The mounting scientific and statistical evidence related to obesity illustrates a number of associated health risks of epidemic proportions. The many complications of morbidity is a head on collision with our current health care crisis.

WHO lists among the adverse effects of obesity including:

• high blood pressure
• high cholesterol
• high triglyceride
• insulin resistance
• respiratory difficulties
• chronic musculoskeletal problems
• skin problems
• infertility
• type II diabetes

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Most parents want the best for their children. We meticulously search labels, check sugar and salt contents, pack balanced lunches, and try to fix healthy meals for our families. But before you pack that applesauce or tuna fish sandwich into your child’s lunch box, you might want to check the bottom of the plastic container or can it comes in to see if it contains BPA, or bisphenol A.

For years’ concerned mothers, environmental groups, and some scientists have been warning that BPA is unsafe, and can lead to cancers, diabetes, and other diseases. The FDA in 2008 claimed that BPA was safe, but offered tips to decreasing exposure, especially to young children and infants. Recently, the FDA has shifted its position and released that it is “encouraging families to limit their children’s exposure to a chemical found in thousands of household products.”

On Friday, the FDA declared that more research was needed and has suggested reasonable steps to limit the amount of BPA exposure. The FDA is now saying that BPA is “of some concern, especially on the brain behavior and prostate glands in fetuses, infants and young children.”

A noted researcher of BPA, Dr. Frederick vom Saal, at the University of Missouri, stated:

“The FDA formally acknowledging concern about BPA and working with NIH to incorporate research from outside of the chemical industry is a huge step forward,” said vom Saal, who is a Curator’s professor of biological sciences in MU’s College of Arts and Science. “The FDA position presented today [January 19} is consistent with the position that the National Toxicology Program made two years ago. Since then, considerable published research reaffirmed the health dangers of BPA. The FDA says they want to respond more quickly. Now, we will see if they are really able to respond to the huge amount of new science showing dangers not recognized two years ago. They should move quickly to restrict the use of by BPA in products used by adults as well as infants."

However, limiting your exposure to BPA isn’t easy and may be hard to avoid because currently, manufacturers aren’t required to label products containing the chemical. The biggest way to decrease your intake of BPA is by limiting your use of canned foods and foods in plastic containers. Baby bottle manufacturers make bottles that are BPA-free and some plastic containers have the number three or seven on the bottom, which means it does contain BPA. Some recycled pizza boxes also contain the chemical, but are not labeled.

The FDA has historically maintained that BPA is safe largely on the basis of two studies funded by the chemical industry. However, more than 100 independent studies linked BPA exposure to health effects in animals and humans. According to a Washington Post article in 2008, a large study on humans and BPA found that “people with higher levels of bisphenol A had higher rates of heart disease, diabetes and liver abnormalities,” a finding that immediately became the focus of the increasingly heated debate over the safety of the chemical. The government has been looking into whether chemical manufactures unduly influenced the FDA’s stance on BPA.

[youtube]http://www.youtube.com/watch?v=PfOcMzMukeY[/youtube]

FDA investigations occurred during February to April of 2009 at a drug manufacturing plant.

A drug recall was instituted in July of 2009.

A voluntary nationwide recall of drugs is instituted on December 21, 2009.

In January of 2010, I am just hearing about it.

The drugs that were recalled were manufactured in a facility, which the FDA cited for violations, including:

1. Failed to monitor and implement quality systems; noted to be a “repeat deficiency”.
2. Drug products failed to meet standards, specifications and quality control criteria.
3. Liquid drugs found to contain foreign particles.
4. Tablets found with “unexplained spots”, but still released to market for sale.
5. Drugs released to the market with unapproved specifications.
6. Various flaws found in the internal investigation process and unqualified person(s) conducted the risk assessment investigation.
7. Effective corrective and preventative actions were not taken by the manufacturer.
8. Water used for manufacturing injection is also used for cleaning, vial washing, and is an ingredient in every product produced in the facility.
9. Violations in incident reporting and investigation were found.
10. In-process control procedures did not include examination of weight variations for tablets and capsules.
11. FDA investigators were required to use flashlights in the “visual exam rooms” due to poor lighting. These are the rooms supposedly used for review of products.
12. The FDA set forth that:
13. “Determinations of conformance to appropriate written specifications for acceptance are not made for drug products.”
14. “Specifically…there are lots of Epinephrine and lots of Xylazine 100 mg injection on the market which have not been tested for particulates. There are…other lots of intravenous products on the market that have never had particulate testing. The Vice President of Quality Management stated they have never conducted the particulate matter test for injectable products including Epinephrine and Xylazine.”

This is an investigation by the FDA, which culminated in a 20 page report of violations; a July 2009 consent decree; and a September 2009 recall.

The press release related to the consent decree set forth, among other things:

In the event of future violations, the consent decree also subjects Teva …Health to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of…drugs in violation of the decree, up to $7.5 million per year.

Pretty scary, huh?

I told someone about this today and their response was, “well it is only involving animal drugs, so no big worries”.

I can read. I can research. I can speak up for my self. My animals can do none of these things. So, for all of you who are health advocates for your significant pets, the recalled drugs include:

Ketamine:

• Ketaset (Fort Dodge/Pfizer)
• KetaVed (VEDCO), KetaThesia (Butler)
• VetaKet (LLOYD Laboratories)
• Ketaject (Phoenix)
• Keta-Sthetic (RVX)
• AmTech Group, Inc.

Butorphanol:

• EQUANOL (VEDCO)
• ButorJect (Phoenix)
• TorphaJect (Butler)

And for those of you who are not pet advocates, here is something to worry about. The manufacturer of all these “animal drugs”, Teva Pharmaceutical, also manufactures many drugs for humans as well.

So, no worries?

The Food & Drug Administration has recently notified Eli Lilly & Co. and Bayer Healthcare that it has objections to ads used for some of their drugs.

For Eli Lilly, it was print advertisements for its depression drug, Cymbalta. Print ads used on WebMD Little Blue Book; a publication to assist patients in locating physicians and other medical services. The FDA set forth that “…the main body of the print ad entirely omits risk information, including the contraindications, warnings and precautions, and the most frequently reported adverse reactions from the [product labeling]” This required information was set forth in a box on an adjacent page, but the FDA felt that it was not “sufficient to provide appropriate qualification or pertinent information for the claims made in the body of the ad or to mitigate the overall misleading presentation,”. An Eli Lilly spokesman responded:

“Lilly remains confident in Cymbalta’s efficacy and safety in its approved indications…”

I am not sure that Eli Lilly really gets the point the FDA is trying to make and one might argue their TV ads are less about the drug and more about “spin”:

[youtube]http://www.youtube.com/watch?v=ijRA3x9sEsQ[/youtube]

For Bayer Healthcare it is their advertising for the drug, Mirena. The FDA’s concerns expressed are very familiar and similar to those already expressed to Bayer and involving its birth control products, Yaz and Yasmin. In the case of Mirena, the FDA set forth that:

“These claims misleadingly overstate the proven efficacy of Mirena,” the letter said. “Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance or intimacy with their partners.”

It would seem that Bayer cannot seem to grasp that marketing prescription drugs to the consumer is about providing complete and adequate information so consumers can make informed decisions and ask their physicians relevant questions about drugs. What marketing prescription drugs directly to consumers is NOT about is “Broadway show” types of productions or the sort of misdirection one can expect from a “three card Monte” carnival huckster.

[youtube]http://www.youtube.com/watch?v=uCg1q0h1PP0[/youtube]

Drug manufacturers, such as Bayer and Eli Lilly, have been selling over the counter, prescription drugs for a long time. They certainly should fully understand the regulations governing advertising and they certainly appreciate the FDA’s need for good information to unsophisticated consumers. It is one thing to use “sleight of hand” advertising with a sophisticated audience such as physicians, but to be more interested in dramatic, glitzy, productions as opposed to accurate, solid information in the case of direct to consumer advertising, is simply wrong.

Do the manufacturers have trouble understanding the FDA regulations?

Of course not. They pay good money to people who are particularly skilled at understanding the advertising regulations. Perhaps the manufacturers are simply testing the extent to which they can push the limits of regulations in order to ramp up sales? Perhaps drug manufacturers have come to believe that regulations are made to be broken; at least long enough to give a product a solid and quick boost in public recognition before they are caught breaking the rules?

Breast Cancer.

It strikes over 187,000 people every year; mostly women between the ages of 40 and 59.

Over 40,000 women die from breast cancer yearly.

Breast cancer in one of the ten leading causes of death for women.

Breast cancer is a family disease — it affects the whole family when a mom, a sister, a daughter develops breast cancer.

These are four of many reasons to support the Susan G Komen Race for the Cure. The Susan G Komen Foundation is one of the single largest sources for support of breast cancer research and treatment.

On January 30, 2010, the South Florida Race for the Cure will be held in West Palm Beach, Florida. So far, this very worthy group has raised over $790,000 toward fighting back the disease of breast cancer.

So for all of us; but certainly for your mom, for your wife, for your sister; sign up for the walk or donate to this worthy cause by going to the Susan G Komen website.

You may recall last year when several accidents and a couple deaths happened as a result of some defective tires manufactured by Chinese companies.

Now, there are reports of bad valve stems manufactured by…you guessed it, a Chinese manufacturer. A recall has been issued involving some six million valve stems.

Apparently, the stems are prone to cracking; causing them to leak; and ultimately the trire goes flat. A flat tire at highway speeds can be lethal and, so consumers are encouraged to check their tires and valve stems for possible deterioration.

You can check the stem by grasping it and gently turning it clockwise. Look for cracks in the stem, particularly where it abuts the tire rim.

The manufacturer is Tech International and the involved models are: TR413, TR413CH, TR414, TR415, TR418, AND TR423, manufactured between July and November of 2006. Unfortunately, it is impossible to determine the manufacturer or model of the valve stem by a physical examination.

For more information, go to the National Highway Safety Administration recall notice and watch this very Bad Tire Valve Stems by Michelle Buckman.

A recent study out of UCLA, published in the January issue of the “American Journal of Ophthalmology,” has found that Age-Related Macular Degeneration (AMD) occurs more than five times more often among female smokers over 80-years-old compared to non-smoking women of the same age. Although this recent study was gender and age specific, this study was the first I had read that causally related smoking cigarettes and potential blindness. It also made me wonder if there is any ailment to which smoking cigarettes will not eventually be linked.

AMD is a disease that causes blurring of one’s central vision, resulting from damage to the nerve cells contained in a small area in the back of the eye. That small area in the back of the eye, known as the macula, enables one to see the fine detail in things that the eyes are focusing on. Macular degeneration makes it harder to do things that require central vision; life activities such as driving, reading and facial recognition become monumental tasks. Smoking cigarettes, according to a 2005 study published in the Eye journal contributes to this damage and subsequent degeneration by decreasing blood and oxygen flow to the eye, resulting in mini-clots in the macula.

If challenged, cigarette advocates would surely refute such findings, citing age as the cause of AMD rather than cigarettes. Certainly, as its name would suggest, age is a risk factor for AMD; but experts believe that the risk begins as early as age 50. And what is undeniable is, like the effects of age on the body, the damage from smoking is likewise cumulative over time. Put another way, according to Michael Rosenberg, M.D., chairman of ophthalmology at Hackensack University Medical Center in New Jersey, “the older you get, the higher the risk for AMD itself, regardless of smoking, that age combined with more time smoking increases your risk.” And according to the UCLA study the increased risk can eventually be as much as five-fold.

Not that smokers need another disease caused by cigarette addiction, but add potential blindness to the laundry list of injuries suffered by them. I wonder how long tobacco companies have known this?

You just have to love Big Tobacco.

Produce a product you know kills people; hide or deflect all the information that would alert the public of the totality of the dangers; engineer nicotine delivery in a way that maximizes addiction and write memos talking about the whole scheme as if you are immune from being held responsible. Then, when you get caught, you rewrite history and hide behind “freedom of choice”.

In an undated memo, Colin Greig, a research and development gentleman for Big Tobacco discusses marketing scenarios which, at least in part, involved his unscientific testing of the way in which his mother-in-law smoked and enjoyed cigarettes; together with her level of addiction. Clearly this must have been the classic “hate your in-law” scenario.

Colin Greig Document

Let me hit the high points of good ‘ol Colin’s memo:

• Cigarettes deliver their drug (think nicotine here) to the brain faster than “other drugs” such as “marijuana, amphetamines, and alcohol”.
• Nicotine “is about the lowest dose” drug available (that still succeeds with addiction).
• Cigarettes are a cheap drug.
• Cigarettes are “a relatively cheap and efficient delivery system…” (think drug delivery here).

Mr. Greig includes in his analysis a quote from Oscar Wilde’s “The Picture of Dorian Gray”:

“A cigarette is the perfect type of a perfect pleasure.

It is exquisite, and it leaves one unsatisfied. What more can one want?”

And, then, Colin concludes with a statement that could not better illustrate Big Tobacco’s methods of operation all along:

“Let us provide the exquisiteness, and hope that they, our consumers, continue to remain unsatisfied. All we would want then is a larger bag to carry the money to the bank.”

Translation: Let’s continue to keep smokers hopelessly addicted and our only problem will be what to do with all that money!

Previous litigation has disclosed other writings by Big Tobacco with which they must now be seen with in the Florida sunshine:

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