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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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    Hog Factories Hit the NY Times

    Byoliveridley

    The tale is told from the pig’s viewpoint. Of course, as I have mentioned before, hog factories are evil and affect the people (mostly poor and black) who live around them in very many horrible ways.

    Pig Out – NY Times

    Of the 60 million pigs in the United States, over 95 percent are continuously confined in metal buildings, including the almost five million sows in crates. In such setups, feed is automatically delivered to animals who are forced to urinate and defecate where they eat and sleep. Their waste festers in large pits a few feet below their hooves. Intense ammonia and hydrogen sulfide fumes from these pits fill pigs’ lungs and sensitive nostrils. No straw is provided to the animals because that would gum up the works (as it would if you tossed straw into your toilet).

    In my work as an environmental lawyer, I’ve toured a dozen hog confinement operations and seen hundreds from the outside. My task was to evaluate their polluting potential, which was considerable. But what haunted me was the miserable creatures inside.

    They were crowded into pens and cages, never allowed outdoors, and never even provided a soft place to lie down. Their tails had been cut off without anesthetic. Regardless of how well the operations are managed, the pigs subsist in inherently hostile settings. (Disclosure: my husband founded a network of farms that raise pigs using traditional, non-confinement methods.)

    The stress, crowding and contamination inside confinement buildings foster disease, especially respiratory illnesses. In addition to toxic fumes, bacteria, yeast and molds have been recorded in swine buildings at a level more than 1,000 times higher than in normal air. To prevent disease outbreaks (and to stimulate faster growth), the hog industry adds more than 10 million pounds of antibiotics to its feed, the Union of Concerned Scientists estimates. This mountain of drugs — a staggering three times more than all antibiotics used to treat human illnesses — is a grim yardstick of the wretchedness of these facilities.

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    Grad student measures hazardous levels of air pollution at cigar show

    Byoliveridley

    Sure makes my graduate work in air quality seem a little tame!

    The man behind the subterfuge (Researcher 2, male) was Ryan David Kennedy, 34, a scrappy Canadian graduate student with crooked glasses who is studying the impact of tobacco on air quality.He crossed the border at Buffalo on Monday morning and on Tuesday crashed the giant cigar party and trade show sponsored by the publisher of Cigar Aficionado magazine at the Marriott Marquis in Times Square.

    At a Cigar Show, an Air-Quality Scientist Under Deep, Smoky Cover – New York Times

    Well, what did he find? Particulate matter readings four times higher than “hazardous”. Sometimes I think of strapping on a sampler and going to the local bar just out of curiosity. I can leave the bar if it gets smoky, the bartenders and wait staff can’t. I don’t see why this is not a clear case of hazardous working conditions leading to an immediate indoor smoking ban.  but what do I know, I’m just a scientist!

    Happy Thanksgiving.

    Blogged with Flock

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    PFOA emissions from Non stick cookware and Popcorn Bags

    Byoliveridley

    Important research coming out of NY. See here for previous PFOA posts. Perfluorinated compounds are used in the manufacture of Teflon, and are bioaccumulative. The theory is that the salts left over in the manufacture (residuals) are offgassing during use, and exposing consumers to bioaccumulative compounds.

    Cast Iron, anyone!!

    Quantitation of Gas-Phase Perfluoroalkyl Surfactants and Fluorotelomer Alcohols Released from Nonstick Cookware and Microwave Popcorn Bags

    Fluoropolymer dispersions are used for coating certain cookware products and food-contact packaging to impart oil and water repellency. Since salts of perfluorooctanoic acid (PFOA) are used as a processing aid in the manufacture of many fluoropolymers, it is necessary to determine if these compounds are still present as residuals after the process used to coat nonstick cookware or packaging, and could be released during typical cooking conditions. In this study, we identified and measured perfluoroalkyl carboxylates (PFCAs), particularly PFOA, and fluorotelomer alcohols (FTOHs; 6:2 FTOH and 8:2 FTOH), released from nonstick cookware into the gas phase under normal cooking temperatures (179 to 233 C surface temperature). PFOA was released into the gas phase at 7-337 ng (11-503 pg/cm2) per pan from four brands of nonstick frying pans. 6:2 FTOH and 8:2 FTOH were found in the gas phase of four brands of frying pans, and the sources of FTOHs released from nonstick cookware are under investigation. We observed a significant decrease in gas-phase PFOA following repeated use of one brand of pan, whereas the other brand did not show a significant reduction in PFOA release following multiple uses. PFOA was found at >5 ng during the fourth use of both brands of pans. FTOHs were not found after the second use of either brand of pans. PFOA was found at 5-34 ng in the vapors produced from a prepacked microwave popcorn bag. PFOA was not found in the vapors produced from plain white corn kernels popped in a polypropylene container. 6:2 FTOH and 8:2 FTOH were measured in the vapors produced from one brand of prepacked microwave popcorn at 223 ± 37 ng and 258 ± 36 ng per bag, respectively, but not measured at >20 ng (LOQ) in the other two brands. On the packaging surface of one brand of microwave popcorn several PFCAs, including C5-C12, 6:2 FTOH, and 8:2 FTOH, were found at concentrations in the order of 0.5-6.0 ng/cm2. This study suggests that residual PFOA is not completely removed during the fabrication process of the nonstick coating for cookware. They remain as residuals on the surface and may be off-gassed when heated at normal cooking temperatures.

    More later.

  • How Safe Is The US Food Supply?

    Byoliveridley

    A good summary of the state of food safety regulation in the United States.

    How Safe Is The Food Supply?

    These known cases make up a tiny fraction of the overall problem–an estimated 76 million illnesses and 5,000 deaths in the U.S. from food poisoning each year. Meanwhile, imports of food, some from countries without strict controls, soared to more than 9 million shipments last year doubling since 2002. The cash-strapped FDA is able to inspect less than 1% of imports. It’s a recipe for disaster. “Our food-safety system in this country is broken,” warned former FDA Commissioner Dr. David A. Kessler at a recent congressional hearing.

    Few incidents ever have a body count high enough to shock the country into making fundamental changes. Overall, “we do have a very safe food supply,” says Sanford A. Miller, former director of the FDA’s Center for Food Safety & Applied Nutrition. But the alarms over pet food and vitamin A have lit a fire under lawmakers and executives. On May 2 the Senate rushed to pass a bill by a vote of 94-0 giving the FDA more responsibilities, such as creating databases of adulterated food. Meanwhile, food producers have been holding emergency meetings with suppliers, looking for problems in their factories or supply chains. Companies are “feverishly examining their own purchasing policies and trying to ensure they are followed,” says Kovacs.

    Note that it is always tempting to blame the bureaucrats here. Bureaucracy is a dirty word in this country, associated with “red tape”, “corruption”, “standing in the way of business”, “pencil pushers”, “big government”, you name it, they get called it. But, agencies like the EPA and the FDA have competent scientists who know what they are doing. But, without the money and the authority, which is given to them by the political arm of the government, they cannot do much. They have also, in recent years, been headed by political appointees who come from the industry they are supposed to regulate and show a distaste for regulation which is in complete opposition of the mandate they are supposed to fulfill as the head of a regulatory agency.

    It’s easy to take potshots at the FDA, but remember who gives them the money, makes the rules and tells them what not to oversee.

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    Arsenic in the News

    Byoliveridley

    Professor wins $1M for arsenic filter – Yahoo! News

    The National Academy of Engineering announced Thursday that the 2007 Grainger Challenge Prize for Sustainability would go to Abul Hussam, a chemistry professor at George Mason University in Fairfax. Hussam’s invention is already in use today, preventing serious health problems in residents of the professor’s native Bangladesh.

    This British Geological Survey website provides a good primer to the problem. Some key points:

    1. Arsenic is very toxic
    2. Arsenic is naturally occurring in the shallow groundwater aquifers of Bengal and Bangladesh at a toxic level
    3. The surface water is contaminated with bacteria and was responsible for high infant mortality, so aid agencies in the ’70s encouraged the use of tube wells and other groundwater pumps. While this contributed to a decline in infant mortality from gastrointestinal infections, it also dosed unsuspecting people with disease causing levels of arsenic
    4. The technology for removal of arsenic is very well known. But most solutions require electricity/periodic maintenance/technical skills and are thus not universal or sustainable.
    5. Simplicity is the key. You can’t tell the people to not drink the water, it is the only clean water available. You can’t install water treatment plants, there is no running water, you can’t rely on solutions that are centralized.

    So with all that in mind, here’s what Prof. Hussam did:

    The Gold Award-winning SONO filter is a point-of-use method for removing arsenic from drinking water.  A top bucket is filled with locally available coarse river sand and a composite iron matrix (CIM).  The sand filters coarse particles and imparts mechanical stability, while the CIM removes inorganic arsenic.  The water then flows into a second bucket where it again filters through coarse river sand, then wood charcoal to remove organics, and finally through fine river sand and wet brick chips to remove fine particles and stabilize water flow.  The SONO filter is now manufactured and used in Bangladesh. That’s great, and easy!

    That’s pretty much freshman chemistry right there, further proof that most innovation does not need new science, only people willing to spend some time on problems that don’t necessarily get looked at.

  • The Carrboro Citizen on the Smoking Ban

    Byoliveridley

    The Carrboro Citizen is a new local paper (less than a month old at this point in time!). It has a well written summary of the current state of North Carolina’s anti smoking bill.

    The Carrboro Citizen

    The fierce behind-the-scenes battle continues over legislation to protect people from deadly second-hand smoke at workplaces, restaurants and bars. Despite his best efforts, House Majority Leader Hugh Holliman has been unable to convince a majority of House members to support his comprehensive plan to protect the public health.

    The opposition has coalesced around a soundbite in this case masquerading as a philosophy, that somehow protecting workers on their jobs is an infringement of private-property rights. Holliman points out that he owns a small business that complies with all sorts of government regulations, including fire safety inspections every year.

    The regulations are designed to protect the health and safety of workers, just like Holliman’s ban on smoking in the workplace. No one is arguing that businesses should be able to refuse the fire inspections and let people who object find other jobs, but that’s what the smoking ban opponents are saying.

    Yes, seems obvious to me, but as I may have mentioned before, property rights is just the catchall excuse here, following the money trail leads to the tobacco industry and to various other entrenched interests represented (as the article points out) by the National Association of Tobacco Outlets! Chris Fitzsimon who wrote this article makes the same point.

    Here’s a nugget tucked away in the middle of the article:

    The latest version of Holliman’s proposal would ban smoking at all restaurants and most bars that serve food, exempting only establishments that function almost entirely as bars and only admit customers above age 21. The bill would not affect smoking at workplaces, but would overturn the 1993 law that prohibits local governments from passing their own anti-smoking regulations.

    This means that private “clubs” like the dead mule (a smoke filled horror that I frequent!) would be exempt. On the other hand, the Chapel Hill and Carrboro local governments could act anyway to ban smoking in these clubs, which to me is a compromise I could live with!

    The Citizen is off to a good start. I have only seen their website (and blogs), looking forward to picking up a copy of the paper version.

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