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Coca-Cola Shareholders Spurred by Conscience or Profit?

April 26th, 2010. By janem

Coca-Cola shareholders know if their coke glass is half-full or half-empty. By that comment I mean they are aware of public concern regarding the safety of Bisphenol-A (BPA), a chemical used in the epoxy lining of Coca-Cola’s canned beverages. Yet at the same time, if something isn’t done about it, sales could potentially drop and so would their dividends. So the shareholders voted last week on a measure that will force the company to go public on plans to rid their beverage cans of BPA.

The Coca-Cola company already eliminated BPA from their plastic bottles, but the plastic used to line aluminum cans still contains BPA. Did the company think this measure would satisfy their shareholders and the public, and they would get away with just a bit of BPA? Apparently not. Shareholders say the company has “failed to provide investors or consumers with sufficient evidence that it is taking steps to address these public health concerns”—and 22% of them voted for a resolution asking the company to publish a report on how it is responding to the “public policy challenges” related to BPA and what they’re doing to come up with alternatives for their beverage cans.

Meanwhile, as reported by Business Wire, Coca-Cola’s Board of Directors today approved the quarterly dividend of 44 cents per common share, up from 41 cents. Coca-cola returned $5.3 billion to shareowners in 2009, through $3.8 billion in dividends and $1.5 billion in share repurchases.

BPA is an endocrine disruptor that interrupts hormones and has been linked with breast cancer, Read the rest of this entry »

Tags: BPA, Coca-Cola, Coke
Posted in Consumer Fraud, Defective Products | 3 Comments »

Regulatory Agencies Up Against Big Pharma and Disease Mongering

April 13th, 2010. By janem

The Food and Drug Administration’s mandate is to protect and promote public health through regulation of pharmaceuticals, etc. But critics question the agency’s lack of attention to prescription drug promotion and disease mongering- the latter described as “widening the boundaries of treatable illness in order to expand markets for those who sell and deliver treatments,” which might in part account for the increasing drug litigation in the US…

And the US, unlike other countries, allows unbranded disease-mongering advertising, the TV ad that doesn’t come right out and mention the drug: instead it ends with “patients are advised to see their doctor”, maybe with a happy family, blue skies and kittens in the background.

In 2004, the FDA stated that unbranded adverts that are perceptually similar or otherwise linked to branded adverts are subject to FDA regulation, as are unbranded adverts by the manufacturer of the only drug in its class. But apart from that, the FDA has no authority over the content of disease-oriented advertising. Obviously, a drug is only worth considering if potential benefits outweigh potential harm. But with ads targeting healthy people, are there added benefits? Where is the FDA?

The FDA vs Other Regulatory Bodies

Worldwide, regulatory agencies have differed in their response to manufacturers’ bids to market their drugs and the major gap appears to be the FDA vs everyone else.

The World Health Organization argues that governments should take a more active role in regulating disease-awareness campaigns to prevent misleading information from reaching the public. The Europeans state that advertising of medicinal products “must encourage the rational use of the product and may not be misleading”. And Canada’s Food and Drugs Act prohibits advertising of a drug that is “false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, merit or safety. ” But the FDA seems to lag and fails to treat regulation of drug promotion as a public health concern. Especially when compared with Therapeutics Initiative.

The University of British Columbia’s Therapeutics Initiative comprises a group of researchers who provide independent evidence-based advice about prescription drugs. “I cannot speak too highly of the Therapeutics Initiative,” said Dr. Sidney Wolfe, a member of the drug safety committee of the FDA and head of the Public Citizen’s Health Research Group.

Not only has the TI saved lives, it has also saved British Columbia taxpayers a lot of money. For example, TI researchers warned Canadians about the arthritis drug, Vioxx, before it was removed from the market for safety reasons. TI assessed the diabetes drug Avandia and cited side effects such as heart attack and angina. As a result, the drug was prescribed much less in British Columbia than the US.

TI has been hailed as “a critical counterbalance to the most profitable industry in the world.”

And with the FDA’s decision to speed up the drug approval process, access to accurate clinical trial information and systematic drug reviews that the TI provides is even more important: increasingly drug manufacturers withhold critical data from the public, resulting in misleading information and potential harm.

Forms of Disease Mongering Used to Expand Drug Sales

• Promotion of anxiety about future ill-health in healthy individuals
• Inflated disease prevalence rates
• Promotion of aggressive drug treatment of milder symptoms and diseases
• Introduction of questionable new diagnoses-such as PMDD or social anxiety disorder-that are hard to distinguish from normal life
• Redefinition of diseases in terms of surrogate outcomes (i.e., osteoporosis becomes a disease of low bone density rather than fragility fractures)

Canadians argue that it is necessary to have an independent body such as the TI to analyze drugs so that they can be treated appropriately, rather than American drug recommendations that are often driven by the drug companies. I wonder how many Americans know about the TI?  But TI might have a short shelf life if pharmaceutical companies have their way. In 2007,  a pharmaceutical task force-INCLUDING SEVERAL REPS OF THE DRUG INDUSTRY-called for an end to the TI’s role in approving drugs (or not). Health critics charged that this decision was putting private interest ahead of public interest-a criticism often thrown at the FDA. Let’s hope that the TI doesn’t get swallowed up by big pharma, like its American counterpart.

Posted in Emerging Issues | No Comments »

Pilots Fly the Friendly Skies

April 7th, 2010. By janem

Pilots on Prozac give a whole new meaning to “Flying the Friendly Skies”. Thankfully, Federal Aviation Administration officials have decided that pilots on antidepressants do not pose a safety hazard-and therefore do not contribute to plane crashes— as previously thought. As of April 5^th, about 10,000 pilots can come clean and disclose the fact that they are taking drugs to fight depression without recrimination.

I think this is the right policy. We know how easy it is to get meds online and I would feel much more reassured if pilots, or any professional person for that matter, were prescribed the right type and amount of medication by a health professional.

According to a Columbia University report from 2005, as many as 10 percent of Americans are taking an antidepressant. So it’s a reasonable inference that many professionals who could affect our well-being and even our lives-from doctors and dentists to firemen to paramedics and pilots-are included in this 10 percent. Why single out pilots? I’d rather have my life in the hands of a calm captain rather than a raving lunatic.

Critics of the new policy will likely point to the side effects of anti-depressants that CAN include hallucinations, insomnia, nausea, headache, diarrhea, anxiety, loss of coordination, dizziness, tremor and even suicidal thoughts. On the other hand, depression can be debilitating to the point of not being able to function. To the point of not being able to work. But the biggest risk from these meds was believed to be drowsiness. Now, the FAA says drowsiness is not an issue. But it is an issue, although not due to meds.

Recent news has made the public aware that pilot fatigue contributes to drowsiness but if the FAA is so concerned about pilots nodding off, why don’t they put a stop to flying more than 12 hours at a stretch? Perhaps pilot fatigue leads to depression. Wouldn’t you be depressed if you worked such long hours that you had to live in a trailer at LAX?

In the coming months, it will be interesting to see how many pilots will “come out”, and if a new policy adresses pilot fatigue.

Posted in Emerging Issues | 1 Comment »

Will Generic Accutane Spawn more Lawsuits?

March 30th, 2010. By janem

Accutane may be buried but the generic form, isotretinoin, is alive and may be hurting. Roche Holding pulled Accutane off the market in June 2009, about 15 years too late for countless victims of Accutane injury. Since its approval in 1984, the drug had been linked to psychological changes, suicidal behavior, auto-immune disease, central nervous system problems, birth defects and most notably,  inflammatory bowel disease (IBD).

But Roche didn’t discontinue manufacturing its blockbuster drug for safety reasons. Instead it had to do with legal and economic issues: generic competitors reduced the drug’s market share to less than 3 percent — Accutane’s departure leaves Claravis (Teva/Barr) with 54.8 percent of the isotretinoin market, followed by Amnesteem (Mylan/GenPharm) and Sotret (Ranbaxy), each with 22.8 percent. And Roche has paid out plenty in personal injury lawsuits. (To date, juries have awarded more than $33 million to patients who blame Accutane for their IBD.)

So the pharmaceutical industry spawns other generic forms of Accutane, called isotretinoin, priced from 10 percent to 65 percent (Sotret) less than Accutane. That may be good news for some lawyers–one attorney has filed more than 100 similar cases against makers of generic isotretinoin–but bad news for teens and young adults who (might) weigh the odds and decide they would rather develop IBD than suffer with acne and hey, the medication is now so much more affordable. Granted, acne can be debilitating emotionally. It can cause high levels of anxiety or depression during teen years, reason enough to disregard more dangerous side effects such as IBD.

The dermatology jury isn’t out on isotretinoin, yet. One dermatologist says that pharmacists mistakenly believe all isotretinoin products are therapeutically equivalent and they prescribe the generic brand because their patients wanted a cheaper product. “Dermatologists were essentially forced by patients to abandon [Accutane],” says Dr. Taub, who believes that “bioavailability from patient to patient differs so much more with generic isotretinoin than with Accutane.” Dermatologist Ty Owen Hanson says Claravis didn’t seem to work for his patients. “It was almost like patients were taking a placebo.”

Another dermatologist, Dr Webester, says Accutane and its generics possess identical pharmacokinetic curves. Dr. Feldman says he sees no difference between Accutane and its generics and doesn’t know which generics his patients get. Generally dermatologists stopped prescribing Accutane when the Roche reps stopped coming by with free samples, about the same time the generic isotretinoin debuted. More than two decades after Accutane’s introduction, it still cost up to $1,200 monthly, versus $600 to $900 for generics.

So the end of  Roche’s blockbuster drug paves the way for other drug companies to cash  in.  But will generic manufacturers remain in the marketplace if they begin to get slapped with personal injury lawsuits? After all, there’s only one way to spell isotretinoin…

Tags: Accutane, Add new tag, defective drugs, Isotretinoin, Roche
Posted in Drugs/Medical | 3 Comments »

Non-Hodgkin’s Lymphoma Linked to Asbestos?

March 24th, 2010. By janem

My close friend was recently diagnosed with non-Hodgkin’s lymphoma-a cancer that began as a tumor in his stomach. Denys just turned 50; he’s a non-smoker and fitness freak. Not even two months after his diagnosis Denys barely has the energy to buy groceries from the corner store-although that could also be due to the chemotherapy kicking the hell out of him.

The doctors can’t explain how or why he has this type of cancer, but his gastrointestinal specialist said that these types of tumors are often seen in people who have worked with asbestos years ago.

“From 1980 to 1995 I worked in home renos, ripping out walls and replacing vermiculite insulation in ceilings with fiberglass,” says Denys. ” Back in those days people weren’t aware; we had no idea.”  (Although mining stopped near Libby, Montana in 1990, The National Institute for Occupational Safety and Health reports that vermiculite is still used throughout the world. It was contaminated with asbestos and asbestos-like fibers. Workplace exposure to these fibers caused-and is still causing– a serious health problem.)

According to asbestos.com, there have been several studies that have suggested a connection between lymphoma and exposure to asbestos, but it also says that no studies have produced conclusive evidence Read the rest of this entry »

Posted in Asbestos Mesothelioma | 25 Comments »