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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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    Stalking my walking.

    Byoliveridley

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    Google Now tells me I have walked 74 km in February (one of the last meaningful acts of my phone before it passed away). That’s mostly me walking from my bus stop to work and back, 3.6 km everyday, something I don’t consider exercise to the point that I undergo serious bouts of self-criticism about “not exercising enough”. I post this because I, like many around me, am very concerned about the amount of digital surveillance in our society. Everyday, Snowden’s document dump brings new revelations. Yahoo webcam images, anyone? But the benefits of benign surveillance are potentially big. I would like my phone to remind me that I am exercising, that my bus is scheduled to arrive in 5 minutes (of course, BC Transit does not have real-time information, so this is theoretical), that I am near a grocery store that has my favourite cereal on sale (this would need open data on retail prices), that my neighbour on the bus is reading the same book that I am (okay, too much!).

    Cellphones are now intelligent, location and context aware. They can do a lot of good. Hell, I’ll even tolerate the use of some of my metadata for advertising and information gathering as long as it is transparent. But the data is also used by governments non-transparently to track my movements and actions, and I am deeply uncomfortable with it. Till now, my gee-whizness and fairly high belief in the value of a trust-based open information commons keeps me from closing off these data streams. If we stop trusting in the good of an open internet and stop contributing, the internet is seriously harmed.

  • Smoking bans

    Byoliveridley

    If you followed the failed attempt in North Carolina this year to ban smoking in indoor public spaces, one of the so called arguments was the famous slippery slope one, that this was only a prelude to banning smoking “in the comfort of your own home”, and other attendant property rights arguments. Well, it turns out that there is an impromptu smoking ban in place in most homes already!

    Study: Smoking forbidden in most U.S. households – CNN.com

    Smoking is forbidden in nearly three out of four U.S. households, a dramatic increase from the 43 percent of homes that prohibited smoking a decade ago, the federal government reported Thursday.

    Before anyone makes the property rights argument that this “ban” is by choice, and not by government fiat, let me make it, and break it. Smoking falls into the category of occupational and reccreational exposure to pollution that harms and kills. It’s no different from lead in the water or smog as far as the non-smoker is concerned. So, property rights are not polluter rights, sorry.

    It’s only a matter of time before smoking indoors is considered completely and utterly unacceptable, kinda like smoking in airplanes!

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    NC House Smoking Bill passes committee

    Byoliveridley

    Updates on the smoking bills I mentioned last week….

    Bill Would Extinguish Indoor Smoking Statewide :: WRAL.com

    Dismissing North Carolina’s heritage as a tobacco state, a House committee on Tuesday passed a far-reaching indoor smoking ban.

    The Judiciary Committee passed the ban by a 9-4 vote. The measure would prohibit smoking in all indoor workplaces in North Carolina, including bars and restaurants. The rules also would apply to private clubs, except those with nonprofit or tax-exempt status.

    The measure would be complaint-driven — local health departments would act on complaints from the public — and violators would first receive warnings.

    “This was a significant and important event to advance the public’s health in North Carolina,” said Dr. Leah Devlin, director of the state Division of Public Health.

    But critics of the legislation, House Bill 259, pointed out that it faces an uphill battle on the House and Senate floors.

    “What they really want is a complete prohibition of indoor smoking in North Carolina,” said state Rep. Paul Stam, R-Wake. “We all know smoking is nasty and dangerous. The question is whether, in a free society, you let people do some things that are nasty and dangerous.”

    Some opponents said passing the bill could set the stage for similar bans inside personal vehicles and homes.

    “You want to smoke and you own the building. Is it really that bad for the public?” asked state Rep. Ronnie Sutton, D-Robeson.

    Yes Paul and Ronnie, not only did you construct a straw man, you blew smoke on it, gave it lung cancer, tortured it with cigarette butts and finally set it on fire. Sheesh, what asses.

    Update

    From Laura Leslie, WUNC (our local NPR affiliate) reporter who maintains a reporter’s blog at WUNC

    Under the current version of the bill, which isn’t available on the web just yet, only NON-profit clubs could allow smoking – like the Elks Lodge, for example.

    So for the standard nightclub or bar, smoking would be banned.

    Hope it helps – and thanks very much for reading!!
    Laura

    So, that’s a lot of progress on the house bill, making it very close to the senate bill.

  • Is Chronic Occupational Pain a Class Issue?

    Byoliveridley

    Americans in households making less than $30,000 a year spend nearly 20% of their lives in moderate to severe pain, compared with less than 8% of people in households earning above $100,000

    Millions of Americans in Chronic Pain – TIME

    Based on a study published in the Lancet (much moolah required to read, funny that the authors of an article on the class/money based nature of pain would publish in a journal that requires all kinds of money to read, heard of PLOS?), one would have to say yes. People in low paying service jobs don’t have the luxury of mid afternoon yoga, or that once a week massage, or being able to take a “mental health” day, or any such luck. Also, the work is physically demanding, long hours of standing, heavy lifting, and repetitive motions the body was not designed for.

    Krueger notes that the type of pain people reported typically fell on either side of the rich-poor divide. “Those with higher incomes welcome pain almost by choice, usually through exercise,” he says. “At lower incomes, pain comes as the result of work.” Indeed, Krueger and Stone found that blue-collar workers felt more pain, from physical labor or repetitive motion, while on the job

    It is very sad, but a lot of this pain is avoidable. Next time you go to the grocery store, notice that the people at the check out counter stand all the time. Why? What about their job requires continuous standing? I’ve been to other countries, Germany for instance, where they are provided with high chairs that help them move the items from the conveyor through the scanner to the bagging area with much less effort. How many chairs have you seen in a grocery store lately?

    Why can’t this very simple system be implemented? It would provide much relief. Three major issues:

    1. Lack of bargaining power: Unions are a dirty word. Last I heard, the unionization rate in the states was 12%. No one speaks for the cashier. It is considered a low paying, low skill occupation where people can be replaced easily and without “pain”. So, you’re on your own, ask for a chair, and you’ll be seated in one very soon (at home, your ass fired and tired).
    2. Money: And this is linked to point 1. Implementation of any programs designed to make workers’ lives a little easier costs money up front. Since workers are expendable and have no voice, it’s easiest to steal from them and deny them basic comforts.
    3. The American notion of individualism: You deserve what you get based on how hard you work and how intelligent you are. Grocery store cashiers must be lazy and dumb to be where they are. they “deserve it”

    I don’t see it changing at all. But next time you walk into a grocery store and find a rather sullen clerk, it’s not that she’s lazy or has a bad attitude, she may just be in a lot of pain.

    Happy Sunday!

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  • FDA to add warnings on Anemia Drugs

    Byoliveridley

    Oncologists are being bribed to over-prescribe these drugs, which seem to cause more harm than good when over-prescribed. The FDA is going to add a “warning” label. Let’s see what it does.

    FDA panel urges curbs on 2 anemia drugs – The Boston Globe

    Best-selling anemia drugs from Amgen Inc. and Johnson & Johnson should have their use restricted because of dangerous side effects, a US advisory panel said. Amgen shares fell the most in five years.

    The panel of expert advisers to the Food and Drug Administration voted 15-2 in favor of new prescribing restrictions and 17-0 for new clinical trials during a meeting yesterday in Silver Spring, Md.

    Shares of Amgen fell $5.77, or 9.1 percent, to $57.33 in Nasdaq Stock Market composite trading. J&J shares fell $1.61, or 2.5 percent, to $62.50 on the New York Stock Exchange.

    The drugs raised the risk of heart attacks, strokes, and death when used at high doses, studies released in the last six months showed. An FDA warning in March prompted the US health program for the elderly and disabled to stop paying for treatments in certain patients, and doctors cut back on use. The products accounted for $6.6 billion, or 47 percent, of Amgen revenue in 2006.

    “Many of us are concerned on the committee and have a lot of questions,” said Gail Eckhardt, an oncologist at the University of Colorado in Aurora, and the advisory panel’s chairwoman.

    The questions concerned the design of trials, why regulators have limited access to results from company studies, and why the drugs have been marketed for improving quality of life if there isn’t sufficient evidence for the claim, Eckhardt said.

    The FDA usually follows the recommendations of its advisory panels, although it isn’t required to do so.

  • Doctors Take Bribes to Prescribe Drugs

    Byoliveridley

    This is the headline I would have used on this story. An incentive scheme to use a paticular product in a situation like this is a bribe.

    Doctors Reap Millions for Anemia Drugs – New York Times

    Two of the world’s largest drug companies are paying hundreds of millions of dollars to doctors every year in return for giving their patients anemia medicines, which regulators now say may be unsafe at commonly used doses.

    The payments are legal, but very few people outside of the doctors who receive them are aware of their size. Critics, including prominent cancer and kidney doctors, say the payments give physicians an incentive to prescribe the medicines at levels that might increase patients’ risks of heart attacks or strokes.

    Industry analysts estimate that such payments — to cancer doctors and the other big users of the drugs, kidney dialysis centers — total hundreds of millions of dollars a year and are an important source of profit for doctors and the centers. The payments have risen over the last several years, as the makers of the drugs, Amgen and Johnson & Johnson, compete for market share and try to expand the overall business.

    So how does this kickback scheme work?

    Federal laws bar drug companies from paying doctors to prescribe medicines that are given in pill form and purchased by patients from pharmacies. But companies can rebate part of the price that doctors pay for drugs, like the anemia medicines, which they dispense in their offices as part of treatment. The anemia drugs are injected or given intravenously in physicians’ offices or dialysis centers. Doctors receive the rebates after they buy the drugs from the companies. But they also receive reimbursement from Medicare or private insurers for the drugs, often at a markup over the doctors’ purchase price.

    Medicare has changed its payment structure since 2003 to reduce the markup, but private insurers still often pay more. Combined with those insurance reimbursements, the rebates enable many doctors to profit substantially on the medicines they buy and then give to patients.

    The rebates are related to the amount of drugs that doctors buy, and physicians that agree to use one company’s drugs exclusively typically receive higher rebates.

    Wow, that’s a scheme that would be illegal in almost any situation. I buy 10 widgets from the manufacturer for $100. The manufacturer then gives me $50 in “rebate”. I charge the person on whose behalf I am buying these widgets $200 even though I am not supposed to make a profit on this transaction, and pocket $150 from a transaction. I also promise to use more of this widget, on people who may or may not need it, but on whom I have such a knowledge gap and power gap that I know that they will use it whether it is actually good for them or not. I also promise not to use a competitor product even though I know that there are cases where one product will be better than the other. Well, who pays, all of us in increased health insurance premiums and healthcare costs so a bunch of rich doctors can drive their Range Rovers around.

    The USA is no different from India when it comes to schemes like this. The money involved is greater, and somehow, this is not called a bribe by the media.

    What does the pharma spokesperson have to say?

    Johnson & Johnson said yesterday in a statement that its rebates were not intended to induce doctors to use more medicine. Instead, the rebates “reflect intense competition” in the market for the drugs, the company said.

    Amgen said that rebates were a normal commercial practice and that it had always properly promoted its drugs.

    Yes, it’s competitive out there, and to ensure that our product gets used, we will bribe people.

    The “consumer” is the person who pays for the product or service. The “consumer” here is the end user, the patient. The patient does not get the rebate, instead having to pay high prices so doctors can add to their six figure incomes. Nice!

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