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Bill could block some ads for new drugs – Not so Fast!

Byoliveridley

Bill could block some ads for new drugs – Yahoo News

Pharmaceutical companies could be prohibited from advertising new drugs directly to consumers for the first two years they are on the market under a bill moving through Congress this week.

The goal, supporters say, is to ensure medicines are safe before allowing industry to promote them to consumers in the hopes they will request prescriptions from doctors.

But a reduction in TV and print advertising, which helped transform medications for heartburn and arthritis into blockbusters, would be a serious financial blow to drug makers. According to one study, every $1 spent on pharmaceuticals advertising often adds more than $2 in sales.

While the Food and Drug Administration already screens a small portion of ads voluntarily submitted by drug companies, consumer advocates favor much tougher regulation, arguing that the studies companies use to test the safety of new drugs are not always large enough to spot dangerous side effects.

“We don’t know, and we won’t know, how truly safe a drug is until it’s been used in millions of people,” said Consumer Reports analyst Bill Vaughan. “The real testing of these drugs takes place after a pill hits the market and that’s why the advertising needs to be regulated.”

This is pretty significant. Big pharma is increasingly reliant on the blockbuster drug that addresses chronic and/or lifestyle diseases affecting the a large proportion of the affluent adult population. To reach this population, you need to target it with massive advertising blitzes that

  1. Alert you to the fact that you might have a problem – Restless leg syndrome, anyone!. This might be something that may be important, but nothing you might have noticed.
  2. Prod you to get treated for it.
  3. Convince both you and your doctor that the flashy new drug, which is 100 bucks per month is so much better than the other drug that is 10 bucks a month (Not much science is necessary here, just a major advertising blitz and continuous access to doctors through visits, “seminars”. “gifts”, etc.)
  4. Work with insurance companies to make this drug the treatment of choice
  5. Lather, rinse and repeat!

Note that advertising is a huge part of this circle, and any restrictions to this said advertising will have pharma crying foul, and free speech. Call me old fashioned, but free speech protects an individual from surveillance, imprisonment, torture, execution, etc. by his oppressive government of choice due to views he/she might have and/or express. All corporate speech is regulated by definition because it involves a flow of information from a party that has a knowledge edge to one, that does not. To the extent that corporate speech helps the end user, it is beneficial. To the extent it hurts, it is not. So regulation of this speech should be a line drawn by government/regulating authority based on maximizing the benefit to the consumer, not to the industry.

Davidson has urged Senate staffers to eliminate the provision on advertising, arguing that the Supreme Court has already struck down similar attempts to regulate commercial speech.

I do not think that in the current regulatory and judiciary environment, this provision has any chance of passing. As long as “commercial” speech is as free as “individual” speech, we will forever be exploited by organizations that have a knowledge gap on us and use this knowledge gap to make us buy/do things that may not necessarily be in our interest.

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    NC smoking bill extinguished?

    Byoliveridley

    Laura Leslie has the scoop…

    Monday: Snuffed Out? — North Carolina Public Radio WUNC

    Looks like House Maj. Leader Hugh Holliman’s smoking ban may be in trouble. The first sign of trouble was that it didn’t come up for a floor vote in the few days following its 9-4 approval in J1 committee. Today, Holliman told NCNN’s Matt Willoughby he’s planning to pull the bill off the calendar when it comes up tomorrow.

    It’s only a matter of time, they can fight it all they want, the smoking bans will pass throughout the country in a a decade or less, that’s a bold prediction!

    Most critics say the legislation goes against private property rights in banning all workplace smoking, regardless of the context. But supporters point out the government has been regulating workplace safety on issues like asbestos for a long time, even on private property. Since secondhand smoke is an environmental toxin, they say, it should be regulated, too.

    As I mentioned in comments on an earlier post, property rights is a catchall rhetorical tool that can defend just about anything, good bad or neutral. So, I am not surprised it is being used here. The obvious counter argument that property rights do not give you the right to pollute is apparently lost on this debate. But this is not really about property rights, is it? It is about protecting the tobacco industry, good old plut-prot-principle!

  • NC Smoking bill dead this year

    Byoliveridley

    The vote was 55-61, and one of the arguments advanced was by Representative Paul Stam (h/t N&O’s new political blog):

    This is pushing smoke out of places where only adults are, but into places where children are. A person who’s addicted to tobacco and can’t smoke all day will get in that car and have to light up three or four or go home and do what they didn’t do during the day. That seems common sense to me.”

    Yeah, and if you stop a murderer from killing in public, he will kill at home, so we should just let him shoot people randomly in public.

    North Carolina General Assembly – House Bill 259 Information/History (2007-2008 Session)

    Whatever, it does not matter, smoking in public will be history even in the South in a decade or less, just a few lawsuits away. I think we first need to overturn the laws against local government passing anti smoking legislation.

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    California Ban on Diacetyl?

    Byoliveridley

    Flavoring-Factory Illnesses Raise Inquiries – New York Times

    For a good background on flavoring-factory lung disease (formerly known as popcorn worker’s lung), check out the Pump Handle’s many posts, especially this recent one. Short primer, diacetyl is the chemical that gives popcorn its so called buttery taste (and smell, it’s fake!!). Well, there’s pretty good evidence that diacetyl causes bronchiolitis obliterans. Some symptoms…

    Bronchiolitis obliterans renders its victims unable to exert even a little energy without becoming winded or faint.

    “The airways to the lung have been eaten up,” said Barbara Materna, the chief of the occupational health branch in the California Department of Health Services. “They can’t work anymore, and they can’t walk a short distance without severe shortness of breath.”

    OSHA has been unwilling to seriously regulate diacetyl, so California, as it is wont to do, is considering banning this killer chemical.

    But in California, which has 28 flavoring plants known to use diacetyl, some legislators and government officials seem unwilling to wait. A bill to ban diacetyl in the workplace by 2010 has passed two committees in the State Assembly and could be taken up by the full body this summer. It is the first proposal of its kind in the nation. Assemblywoman Sally Lieber, the author of the bill, said she introduced it because of what she said was the slow response by the flavoring industry, which is largely self-regulating on occupational safety. “What we’ve heard is that the flavoring industry has known for years that this is potentially a problem, and they haven’t taken action,” said Ms. Lieber, a Democrat.

    I am all for California’s regulation. But as written, this law will only protect workers in California. They should also consider going one step further by restricting the use of diacetyl in food sold in California. Only then can the giant market that is California exert its influence on the diacetyl manufacturers and users.

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    Sugar Pills, now more effective!

    Byoliveridley

    Well, all sugar is not bad for you. Apparently, when given to you in pill form by someone wearing a white coat with a pleasant demeanour, it can cure all kinds of ills.

    It’s not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today's economy, the fate of a long-established company can hang on the outcome of a handful of tests.

    Via Wired

    An interesting article that takes the reader through a recent history of placebos, why they seem to work better now than they used to, and tangentially, why the competitive research paradigm of the pharmaceutical industry delayed recognition, and continues to delay possible fixes and therapies.

    A few things about the placebo effect:

    1. There appears to be a physiological and neurological basis to the effect, something that can actually be turned off by deactivating the body’s natural production of opioids.
    2. This effect is triggered by various patient stimuli, including exposure to advertising, faith in the medicine, doctor bedside manner, etc. It appears that for minor ailments, these effects could be as strong as the medication prescribed.
    3. It is not short lived, the effects can linger well after consumption of sugar pills.
    4. Despite all this, the article states that we are no closer to finding the most appropriate way to administer placebos (Hmm, or are we? Read on!).

    Pharmaceutical companies conduct hundreds of clinical trials every year. They are not required to publish them in most countries, so negative results, failures, etc. which reflect badly on the company’s stock price are routinely hushed up. This means that the mounds of data that show tested drugs as no better than placebo are not accessible for research. This is one of the greatest drawbacks of competitive research paradigms, the lack of cooperation, the inefficiency that comes from duplication of negative results, and the lack of statistical power that comes from inability to use all the data available. In a milieu where knowledge = stock price, this is the logical approach, but something to note next time an Ayn Rand acolyte comes bleating to you about the beauty and perfection of the market. You might ask “What are some options to the current patent exclusivity driven regime”? My favourite economist Dean Baker of the Center for Economics and Policy Research has written extensively about the drug development process and alternatives in his excellent (and free to download) book The Conservative Nanny State, I suggest reading at least the chapter on drug development and patents!

    Anyway, back to placebos, what to do? How to administer sugar pills in a quasi-official setting for minor ailments. It’s almost like you need a parallel paradigm of medicine that dispenses sugar pills that did not have to go through double blind randomised clinical trials. it would help if this paradigm uses vaguely scientific terminology while doing very little harm. It would work in conjunction with the conventional approach, not in competition so there is little danger of people taking sugar pills for malaria!

    I give you, Homeopathy!!! This blog(ger) is no stranger to this wonderful form of medicine, involving concepts such as the memory of water, similars, dilution, etc. When I wrote about homeopathy last year, it was more in relation to the psychological aspects of my experience with it. I (and I assume you did not click through to read!) wrote about my parents’ great and enduring relationship with their homeopath, and the benefits it brought them. Back in India this time around, it was suggested that I take some homeopathy for a cold I was developing, which I did (yum, sugar!). The cold went away in a few days 🙂 There was some swine flu medicine being passed around as well (I did not partake), which worked too, nobody at home got swine flu 🙂

    So, how to make it work? It already works in India because belief in the efficacy of homeopathy is well established. As long as the homeopath is well qualified in basic diagnosis, and crucially, knows when to punt the patient into conventional therapy, the system works to a certain extent. But what about a society with no such foundation? Do you go to a clinic with both an allopath and a homeopath, and if your ailment is one where placebo works about as well, let the homeopath make some well diluted similars for you to consume? How to settle turf wars? Would it be better for the allopath to feign develop an expertise in homeopathy and make that work for her in treating the patient? Would they apply the most important lessons in homeopathic treatment, Listen, Empathise, Soothe?

    I don’t know. It is not my nature to believe in sugar pills, faith, or advertising. So it is hard for me to say what would work. But given that sugar pills work well, it is vital for society to find a way.

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    Men – An Endangered Species due to Endocrine Disruptors.

    Byoliveridley

    Why, it’s a girl, how surprising!!

    Man-made chemicals blamed as many more girls than boys are born in Arctic | The Guardian | Guardian Unlimited

    Twice as many girls as boys are being born in some Arctic villages because of high levels of man-made chemicals in the blood of pregnant women, according to scientists from the Arctic Monitoring and Assessment Programme (Amap).
    The scientists, who say the findings could explain the recent excess of girl babies across much of the northern hemisphere, are widening their investigation across the most acutely affected communities in Russia, Greenland and Canada to try to discover the size of the imbalance in Inuit communities of the far north.

    In the communities of Greenland and eastern Russia monitored so far, the ratio was found to be two girls to one boy. In one village in Greenland only girls have been born.

    Why are the upper latitudes especially vulnerable? Two reasons, firstly, atmospheric currents carry pollutants from the Mid-Latitudes (i.e the US, China and Europe) to the higher latitudes of the Arctic. Secondly, the pollutants they measured, PCBs, are persistent and stable (which is why they were used in the first place) and accumulate in the fat tissue of animals. So, predator fish on top of the food chain (the large oily ones) tend to accumulate a lot of these compounds. When you live in the Arctic, you tend to eat a lot of fish. So, these people are getting slammed.

    I tell you, Children of Men is not as far fetched as it sounds! Though I think the high levels these people accumulated in their system may not be representative of the rest of the world (vegetarian diets, for instance would be lower in persistent pollutants unless you consumed a ton of milk products), it is still a very scary story.

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    The real terrorist: Pollution

    Byoliveridley

    It is true. A staggering number of people die every year due to lack of access to clean water, air or food. Aggregate statistics like these are a good way to summarize the humongous nature of the problem. While reams and reams of coverage and attention are focused on “terrorists”, people all around the world die of much more mundane causes such as bacteria in water, smog, poverty, starvation, malnourishment, etc.

    ScienceDaily: Pollution Causes 40 Percent Of Deaths Worldwide, Study Finds

    About 40 percent of deaths worldwide are caused by water, air and soil pollution, concludes a Cornell researcher. Such environmental degradation, coupled with the growth in world population, are major causes behind the rapid increase in human diseases, which the World Health Organization has recently reported. Both factors contribute to the malnourishment and disease susceptibility of 3.7 billion people, he says.

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