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I think it was around Christmastime last year, while frantically traipsing through the mall in search of bargains, that an over-eager kiosk salesperson stepped into my path.  Wonderful, I thought.  Another person trying to sell me overpriced hand cream. I tried to go around her, hoping she’d get the hint—to no avail.  Oddly, instead of launching into a speech about my unhealthy cuticles, she asked me if I was a smoker.

And that’s when I noticed she was selling e-cigarettes:  plastic cigarettes that look almost exactly like the real deal. (They even puff out odorless vapor that looks strikingly like cigarette smoke.)  She explained to me that these can be a great tool for quitting smoking, because they look and feel like cigarettes.  “It’s just like smoking, but without the nasty health effects.”

What a cool idea, I thought.  My father, a former (heavy) smoker, told me once that quitting smoking was a total nightmare for him.  Why? Because he didn’t just crave the nicotine in the cigarettes; he craved the whole smoking ritual: taking that first puff of the day while sipping his coffee, taking breaks at work and chatting with his friends, etc, etc.  Quitting smoking wasn’t just about omitting nicotine from his life; it was about changing his lifestyle.

From that perspective, e-cigarettes seem like a good way to ease the transition from smoker to non-smoker. They look like cigarettes, taste like cigarettes, and feel like cigarettes but the “smoker” is no longer exposed to  40+ human carcinogens multiple times a day.  On top of that, e-cigarettes don’t produce that thick, noxious cloud of smoke that clings to your hair, skin, and clothing, and makes everyone around you cough.   “I feel like this could save my life,” said one satisfied customer, who reported cutting her smoking from 3 packs a day to 1 ½ packs a day.(1)

But Katie Zezima of the New York Times astutely points out the dark side of these products—namely, that we don’t really know anything about how safe they are. Read the rest of this entry »

By Lindsey Realmuto

As of January 1, 2009 we can all rest assured that pharmaceutical companies may voluntarily stop barraging our physicians and nurses with free mugs, pens, and trinkets carrying drug logos. PhRMA, the pharmaceutical industry trade group, has updated their industry marketing guidelines, and the companies that choose to comply with them will stop giving free logoed items to prescribers. Thank goodness! Now I feel safe that my doctor is free from the shackles of industry influence.

Returning to reality, what we as patients and consumers should be more concerned about is how the pharmaceutical companies are using this tiny concession to dodge the regulatory bullet of eliminating corporate financial entanglement within the healthcare system. And why wouldn’t they?! The marketing strategies of pharmaceutical companies over the past almost 30 years have skyrocketed them to the top of the global corporate ladder. Jacky Law in Big Pharma: Exposing the Global Health Agenda reports that the top ten pharma companies in 2005 had a combined income of more than $205 billion!

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by revere, cross-posted at Effect Measure

One of the triumphs of 19th and 20th century public health was the provision of piped water into cities and towns. With the use of modern methods of disinfection (primarily chlorination) water as a source of mass distributed poisons rapidly receded, and with it the preponderance of infectious diseases that were the scourge of urban life. Urban water supplied were an efficient means to provide a healthy required substance, water, to the whole population and once. But of course it is also an efficient means to distribute unhealthy stuff — not just microbes but chemicals. I’ve worked on the health of effects of chemicals in drinking water for many years and I wish I could say that the chemicals that occupied much of my professional attention — solvents, organic contaminants, by-products of the disinfection process — were off the radar screen. They aren’t. They are still around and causing trouble. But now the radar screen has gotten more crowded, with blips representing chemicals that mimic hormones and more and more often, pharmaceuticals. A paper just published in the journal Environmental Science & Techonology (ES&T) is quite surprising. Surveying 29 water supplies serving more than 28 million people, the most frequently found chemicals were unregulated organics, all pharmaeuticals except for one regulated pesticide.

Here’s the top 11 (via New Scientist):

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by Susan F. Wood, PhD

Recently the New York Times and RHRealityCheck reported on a leaked internal proposed regulation that calls for more and different enforcement of anti-discrimination provisions for health care providers.  The provisions are forms of conscience clauses that do not allow discrimination in hiring or promotion of health care workers who do not wish to perform abortion or sterilization (or indeed in the reverse, no discrimination against those who do perform abortions or sterilizations) in federally funded settings.

The draft regulation goes into detail outlining the history of the laws protecting the conscience of health providers and entities and then outlines the problem.  It seems that the central concern is not discrimination against those who won’t perform abortions, but that the US Department of Health and Human Services sees a real problem with requiring health professionals (and anyone in the healthcare workforce) to be involved with contraception, even if it is part of the job.  The majority of the section outlining “The Problem” concerns states that have passed laws or issued executive orders requiring pharmacies to dispense contraception, including emergency contraception, and that require hospitals to provide emergency contraception to rape victims. 

From the regulation:

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by David Egilman, MD, MPH

I just finished watching the Waxman hearings on FDA preemption and must comment on Christopher Shays’ (R-CT) comments.  Christopher Shays is the last remaining Republican congressman from New England.  Hopefully the November elections will result in the extinction of this last remaining
remnant of the age of the dinosaurs.

He repeatedly stated that he “had no dog in this hunt” concerning the impact of preemption and torts suits on drug safety. This is a peculiar position for a Congressperson who must decide whether or not the FDA’s actions are appropriate.  It’s one thing to have no opinion; it is in another to imply that there is no reason to have opinion.

Read the rest of this entry »

by Susan F. Wood, PhD 

The FDA Amendments Act (FDAAA) of 2007 includes a small section addressing direct to consumer (DTC) advertising.  The bill doesn’t limit advertising to consumers, nor does it give FDA authority to put a moratorium on advertising while more data on safety or effectiveness is collected during the first months or years that a product is on the market.  A moratorium was recommended by the IOM in it’s drug safety report in 2006, but was not adopted by Congress – perhaps due to arguments about first amendment rights, but perhaps due to objections by both the pharmaceutical industry and the advertising industry.

What was included is a small section requiring that all print DTC ads carry “the following statment printed in conspicuous text:  ‘You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 1-800-FDA-1088′ “

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by Susan F. Wood, PhD 

It’s not often, if ever, that an FDA sponsored report calls out for more resources, more direct action and organizational change for FDA.  The recently released report (PDF) by the Subcommittee on Science and Technology for the FDA Science Board does just that.  Although I wouldn’t necessary agree with all of the recommendations, and would call out for a few more, the report identifies some of the real needs at FDA for strengthened science.  The FDA Science Board, an Advisory Committee to the FDA, has issued earlier reports, but none with the timeliness and potential impact of this one.  Most of the press coverage has been on the call for expanded resources – which are truly needed – but the report also identifies some of the scientific infrastructure needs that trail behind our expectations of this critical public health agency.  I don’t know if FDA expected this type of report, but hopefully it can be useful as a way to move the agency forward.

From the report:

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by Susan F. Wood, PhD 

FDA recently announced two draft guidances regarding advisory committees, one on public disclosure of financial conflicts of interests and the other on voting procedures

  Read the rest of this entry »

 By Susan F. Wood, PhD

 Two things appear to be major bones of contention in determining the final version of what is now named the “FDA Revitalization Act of 2007″ (FDARA).  And they both related to public transparency and public accountability. 

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The following post is by Dr. David Egilman, a familiar figure to those who have been following the case of Eli Lilly’s schizophrenia drug Zyprexa. See Alex Berenson’s New York Times articles on the case for more background, or read David Michaels’s post about Zyprexa and sequestered science. — Editor

“The Truth is Not Free”
By David Egilman
September 11, 2007

All that is needed for the forces of evil to succeed is for enough good people to remain silent.
– Edmund Burke

The consequences of silence can be devastating.  My father spent WWII in a German concentration camp largely as a consequence of silence. In response to the Holocaust, which was facilitated by the silence of a nation, I have devoted much of my professional career to studying and reporting the effects of silence on public health.

Last December, I was subpoenaed for copies of internal documents that I acquired as a consulting witness in litigation against the pharmaceutical company Eli Lilly. I released all of the documents I had, which made their way to The New York Times and became the basis for four major articles. After the Times stories ran, 30 states subpoenaed documents detailing Lilly’s sales, marketing and promotional practices for Zyprexa as part of civil investigations under state consumer protection laws.

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