Monday, May 24, 2010

Many Sunscreens May Be Accelerating Cancer

WASHINGTON (May 24) -- Almost half of the 500 most popular sunscreen products may actually increase the speed at which malignant cells develop and spread skin cancer because they contain vitamin A or its derivatives, according to an evaluation of those products released today.

AOL News also has learned through documents and interviews that the Food and Drug Administration has known of the potential danger for as long as a decade without alerting the public, which the FDA denies.

The study was released with Memorial Day weekend approaching. Store shelves throughout the country are already crammed with tubes, jars, bottles and spray cans of sunscreen.

The white goop, creams and ointments might prevent sunburn. But don't count on them to keep the ultraviolet light from destroying your skin cells and causing tumors and lesions, according to researchers at Environmental Working Group.

In their annual report to consumers on sunscreen, they say that only 39 of the 500 products they examined were considered safe and effective to use.

The report cites these problems with bogus sun protection factor (SPF) numbers:

-The use of the hormone-disrupting chemical oxybenzone, which penetrates the skin and enters the bloodstream.

-Overstated claims about performance.

-The lack of needed regulations and oversight by the Food and Drug Administration.

But the most alarming disclosure in this year's report is the finding that vitamin A and its derivatives, retinol and retinyl palmitate, may speed up the cancer that sunscreen is used to prevent.

A dangerous additive

The industry includes vitamin A in its sunscreen formulations because it is an anti-oxidant that slows skin aging.

But the EWG researchers found the initial findings of an FDA study of vitamin A's photocarcinogenic properties, meaning the possibility that it results in cancerous tumors when used on skin exposed to sunlight.

"In that yearlong study, tumors and lesions developed up to 21 percent faster in lab animals coated in a vitamin A-laced cream than animals treated with a vitamin-free cream," the report said.

The conclusion came from EWG's analysis of initial findings released last fall by the FDA and the National Toxicology Program, the federal government's principle evaluator of substances that raise public health concerns.

EWG's conclusions were subsequently scrutinized by outside toxicologists.

Based on the strength of the findings by FDA's own scientists, many in the public health community say they can't believe nor understand why the agency hasn't already notified the public of the possible danger.

"There was enough evidence 10 years ago for FDA to caution consumers against the use of vitamin A in sunscreens," Jane Houlihan, EWG's senior vice president for research, told AOL News.

"FDA launched this one-year study, completed their research and now 10 years later, they say nothing about it, just silence."

On Friday, the FDA said the allegations are not true.

"We have thoroughly checked and are not aware of any studies," an FDA spokesperson told AOL News. She said she checked with bosses throughout the agency and found no one who knew of the vitamin A sunscreen research being done by or on behalf of the agency.

But documents from the FDA and the National Toxicology Program showed that the agency had done the research.

"Retinyl palmitate was selected by (FDA's) Center for Food Safety and Applied Nutrition for photo-toxicity and photocarcinogenicity testing based on the increasingly widespread use of this compound in cosmetic retail products for use on sun-exposed skin," said an October 2000 report by the National Toxicology Program.

FDA's own website said the animal studies were done at its National Center for Toxicological Research in Jefferson, Ark. And it was scientists from the FDA center and National Toxicology Program who posted the study data last fall.

Wednesday, May 12, 2010

Vertebroplasty No Better Than Sham For Painful Osteoperotic Fractures

At least that's what the New England Journal Of Medicine is reporting. This randomized double blind, placebo controlled study took participants with one or two painful osteoperotic fractures unhealed and less than 12 months old by MRI and randomized them to either vertebroplasty or sham.

For the nonmedical types out there, vertebroplasty and kyphoplasty involves the injection or balloon expansion of a compressed vertebrae, the theory being that this action will decrease the back pain associated with fractures. The only indication to have one, that I'm aware of, is to treat uncontrolled pain.

Interestingly, 5 years ago we didn't have such a procedure. Patients with compression fractures got pain meds and Miacalcin and told to wait it out. They were told that as the bone healed the pain would improve. We would use moist heat and ultrasound to hasten the healing, then soft tissue adjustments.

Today, just about every acute compression fracture with associated pain gets an MRI and then gets evaluated by either an interventional radiologist or an orthopedic spinal surgeon for evaluation for vertebroplasty or kyphoplasty.

In the study above the primary outcome being measure was pain. Using the primary outcome of pain at 1 month, 3 months and 6 months the study showed no difference between the treatment group and the sham (placebo) group.

This is huge. HUGE. Granted, the study was small, but it appears to be well designed.

This is the second clinical study showing that vertebroplasties are worthless. And the studies were performed by spinal surgeons themselves!

People believe that invasive means better. It's engrained in the American culture where you have to be a specialist that does something to be worth your time and money. Why get pain medication or chiropactic care when you can get needles and cement at 1000 times the cost..... that must work.

This study is a fascinating example of the power of special interest groups infiltrated into clinical medicine. Early studies indicated the vertobroplaties and kyphoplasties may have clinical benefit. The key word is "may". They get approved by the Medicare National Bank as showing benefit over placebo and then everything gets paid for at enourmous cost to the MNB.

I would like to know how these procedures ever made it into mainstream medicine without strong scientific evidence to its efficacy, especially considering their cost to the public Treasury. Chiropractors are constantly ridiculed as being "unscientific", yet we have more clinical studies that show what we do works than most surgical procedures do!

Situations like this tend to weaken the standards of Western medicine which are supposed to be science based, but are looking more and more like they are financial based. Get a bunch of device manufacturers to back a less than optimal study design, gain favor from the radiological and orthopedic societies, which have direct finanical interests in the matter, and spread your position statements out to the world. And make it the gold standard.

Medicine is killing us....and you are paying for it!

Saturday, May 8, 2010

Drugs Are Not The Solution-They Are The Problem!

Every day Americans are subjected to a barrage of advertising by the pharmaceutical industry. Mixed in with the pitches for a particular drug—usually featuring beautiful people enjoying themselves in the great outdoors—is a more general message.

Boiled down to its essentials, it is this: “Yes, prescription drugs are expensive, but that shows how valuable they are. Besides, our research and development costs are enormous, and we need to cover them somehow. As ‘research-based’ companies, we turn out a steady stream of innovative medicines that lengthen life, enhance its quality, and avert more expensive medical care.

You are the beneficiaries of this ongoing achievement of the American free enterprise system, so be grateful, quit whining, and pay up.” More prosaically, what the industry is saying is that you get what you pay for.

Is any of this true? Well, the first part certainly is. Prescription drug costs are indeed high—and rising fast. Americans now spend a staggering $500 billion a year on prescription drugs, and that figure is growing at a rate of about 12 percent a year (down from a high of 18 percent in 1999).1 Drugs are the fastest-growing part of the health care bill—which itself is rising at an alarming rate. (And I don't mean the Obama Care Bill).

The increase in drug spending reflects, in almost equal parts, the facts that people are taking a lot more drugs than they used to, that those drugs are more likely to be expensive new ones instead of older, cheaper ones, and that the prices of the most heavily prescribed drugs are routinely jacked up, sometimes several times a year.

Over the past 3 decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)

If prescription drugs were like ordinary consumer goods, all this might not matter very much. But drugs are different. People depend on them for their health and even their lives. In the words of Senator Debbie Stabenow (D-Mich.), “It’s not like buying a car or tennis shoes or peanut butter.” People need to know that there are some checks and balances on this industry, so that its quest for profits doesn’t push every other consideration aside. But there aren’t such checks and balances.