Drug Safety Bill Would Limit Direct To Consumer Advertising

Supporters of a new bill working its way through Congress say that limiting the amount of direct to consumer advertising in the first two years of a drug’s life would help insure that drugs are safe before patients are encouraged to seek prescriptions from their doctors.

From the Wall Street Journal:

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.”

For its part, the drug industry says pharmaceutical ads are an important tool for patients, giving them information about diseases and treatment options.

“Banning this information even for just a couple of years is not in the best interest of patients and physicians who every day make important health-care decisions,” said Ken Johnson, Vice President for the Pharmaceutical Research and Manufacturers of America.

Drug makers spent nearly $5 billion on direct-to-consumer advertising last year, according to Nielsen Media Research, and a 2004 study found that American TV viewers watch an average of 30 hours of drug ads per year.

The legislation in question was drafted by Senators Ted Kennedy (D, Mass.) and Michael Enzi (R., Wyo.) in response to public outcry surrounding the recall of the drug Vioxx. —MEGHANN MARCO

Drug-Safety Bill Would Limit Direct-to-Consumer Advertising [Wall Street Journal]
(Photo:loveitmadly)

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  1. niccernicus says:

    Let’s just make everyone happy….

    Tobacco companies are allowed to advertise…drug companies advertise quit smoking drugs.

    Eat more beef ads…cholesterol lowering meds.

    Alcohol ads….more herpes/std med ads.

    By the way, does the herpes medicine company have a deal with the motorcycle companies? There’s always a bike in the commercials.

  2. facted says:

    Now this would be an advance, and hopefully drug prices would begin to ease a bit. Not to mention that patients would not come into doctor’s office requesting (sometimes demanding) pills that aren’t even meant for their medical condition (trust me, it happens).

    New Zealand and the US are the only countries in the world that allow direct marketing to consumers for drugs and it’s about time we leave New Zealand in the dust.

  3. magdelane says:

    WTF?

    “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.”

    Aren’t clinical trials and the like supposed to be determining this? Sounds like we might be a bit hasty getting some products to market…

  4. Darren W. says:

    People need to be responsible for what they choose to take. If a drug just hit the market a few months prior, people should take that into consideration. Besides, if twice as many people take a drug when it first comes out, due to marketing, then the bad side effects may well be discovered in half the time.

    Additionally, am I the only one who sees that they’re talking about using patients as guinea pigs for the first year or two after a drug’s release?

    And no, this won’t make the drug prices go down, it will cut into the drug companies profit margins, and if anything, will make the prices go up.

  5. facted says:

    Clinical trials are often done in limited patient populations, with limited study size, and with the inability to control for some factors. They are obviously necessary to provide evidence that a drug is beneficial and safe, but sometimes the true effects of a drug are not known for many years after it’s been introduced as it gets into the general population who have various medical conditions that may not have been included in the original studies.

    Also, it is possible that drugs may be harmful over the long haul and since clinical trials for drugs may be shorter-term (maybe 1,2 or 3 years, for example), you may not see effects for a longer time frame.

    One point of reference: The whole Vioxx scandal would not have been nearly such a big deal had the correct patient population been using the drug (those who cannot take NSAID’s such as Aspirin for whatever reason). Instead, large marketing campaigns got millions of people on the drug early on, unnecessarily. When the shit hit the fan, millions of people were exposed to the risk of the drug who had no business being on the drug in the first place.

  6. MercuryPDX says:

    @facted: yes… hypochondriacs even get a list of symptoms they can fake themselves into having.

    Although I do find the laundry list of side effects at the end of most of them entertaining: “The most common Zoloft side effects are dry mouth, insomnia, sexual side effects, diarrhea, nausea, and sleepiness.”

    Mmmmm… now there’s something to be depressed about.

  7. facted says:

    @Darren W.: The price argument goes something like this: People don’t know a drug exists (only doctors know). Doctors take into account a drug’s effects and if they know a patient may not be able to afford a certain medication, they actually take price into effect as well in making medication recommendations. If a drug is super-expensive early on, and patient’s are in doctor’s faces clamoring to get the drug, then a doctor will simply give the cheaper, tried and true drug.

    It is the hysteria of a new drug (and the patient’s request to the doctor) that allow the price to be inflated since the patient wants the latest and greatest best thing.

  8. BillyShears says:

    For its part, the drug industry says pharmaceutical ads are an important tool for patients, giving them information about diseases and treatment options.

    Call me crazy, but if I want to self-diagnose myself I’ll take a swig of Jack and read Wikipedia and about.com, which are (sadly) probably less biased and more informed than the commercial trying to convince me that I toss and turn at night is something worth visiting the doctor about.

    I’ll leave information about what ails me and the appropriate action to take to my doctor. All these ads do is play to hypochondriacs.

    (I will miss the free comedy provided by those ads. Nothing like a social anxiety drug that causes gas, the runs and possibly impotence!)

  9. typetive says:

    This will be a terrible blow to voice over actors who specialize in being able to coherently spew out volumes of technical jargon within ten seconds for those commercials.

    And think of the loss for stock photographers. No more buyers for couples walking on the beach at sunset.

  10. MentalDisconnect says:

    For my medical condition, I research the med, talk to people who have tried it, and discuss it thoroughly with my doctor. I know a fair bit about biology and medicine and I own a copy of the Nursing Drug Reference for just a bit of light reading. An ad won’t convince me. All it does is raise my awareness of it so I can research it. I am wary of new drugs, had some bad side effects.

    I know I’m unusual for a consumer. I’m not expecting everyone to be like me. I really think the doctors ought to be responsible for insuring the safety of the patient- if they have their doubts about Miraculous X, then he/she should be cautious about prescribing it. Too often I feel like doctors are the ones in love with the newest medication.

  11. facted says:

    @MentalDisconnect: While I wish it were that simple, you are right in pointing out that you are far different from most consumers. The fact of the matter is that patients will often visit their doctors and DEMAND medications. As a doctor, you can obviously decide what to prescribe, but if you don’t give them their med they’re asking for, then you may just have lost a patient. That patient will just go to the next guy, who will give them their med.

    While I clearly don’t think people are forking over opiates just because someone wants some, you’d better believe that antibiotics for a common cold are VERY VERY common. If you think the drug isn’t going to harm a patient, then in reality there is little reason to not give a patient any medication they’re demanding.

    Of course, as a doctor, you have to weigh everything and it’s not easy, but it happens every day.

  12. silverlining says:

    WHY does the US allow drug companies to advertise prescription drugs at all?

    I used to work in an oncology pharmacy. Among other drugs, we prepared Procrit, designed to encourage red blood cell production–chemo kills all rapidly growing cells, including RBCs. It’s about a mL of drug, and cost somewhere around $1k per dose.

    Imagine my surprise when I saw *commercials* for Procrit. There is a very specific medical condition that would merit Procrit, and yet it’s advertised to huge audiences as if it was for common aliments like aspirin or cold medicine.

    Anyone who knows the price differential between generics and name brand can tell you how much advertising drives up the price of ANY product. There is no sound reason to advertise prescription drugs. We should go back to the way it was.

  13. MentalDisconnect says:

    To facted: It seems ridiculous to demand a drug. They’re not doctors. I have been insistent on a particular medication before, but usually I’ve made my decision from more than people smiling on a beach. Oh, that reminds me, I did a parody of a drug ad a year ago. I was spinning and dancing in a sunny dewy field, very good soft lighting with it being slightly misty, and after doing my spinning and dancing I picked up a friend’s stuffed animal and hugged it, smiling at the camera. Yes, I am an adult male, but all in the name of art..

    I know what you’re saying about the anti-biotics. That worries me because I know how resistance can be built up and this overprescription of anti-biotics seems dangerous. At least we’re no longer putting penicillin in our cereal…

    Silverlining, you are correct, there is no reason to advertise that product, or any other kind of prescription drug. I would be extremely suprised to see medication for my condition advertised- it would be ridiculous. I can understand common ailments being advertised for, like high chlosterol.. but it still seems inappropriate if a patient doesn’t need it or it’s the wrong drug but the patient demands it. Medication should be a decision between the doctor and the patient, and the advertising should stay out of it.

    Are there any doctors who can say if they’ve felt pressured to prescribe a certain med more often?

  14. facted says:

    @MentalDisconnect: I’m a med. student and I’ve worked with many doctors in clinics and in their practices, and trust me, “drug demand” happens all the time. I agree with you that obviously no one should be demanding any drug, but it happens…a lot.

  15. Greeper says:

    Because less information is so much better than putting it out there and letting people make their own choices….Just what we need, ~550 Congressmen deciding what words we can see/hear.

  16. etinterrapax says:

    @MercuryPDX: I noticed that too. A while ago, a side effect of an asthma medication was listed as bronchitis. Gee…!

    I can’t feel sorry for the drug companies. They’ve gotten fat and happy on people’s paranoia and doctors’ need for expediency. I never liked direct-to-patient advertising and the less I see of it in the future, the happier I’ll be.

  17. chael38 says:

    Big Pharma probably couldn’t care less now that Medicare Part D has provided them with pretty much captive patient populations. Watch for the insurance company preferred-drug formularies to fill up with new drugs with short track records.

    We need more patient/health literacy! Direct-to-consumer at least incorporates individuals in the process. Maybe the way to go is to have workshops where patients can learn how to do reliable research, how to dialogue with physicians, etc.

  18. getjustin says:

    I’ve never understood how the FTC and the FDA let the pharm companies get away with the amount of advertising they do for prescription drugs.

  19. ozraven says:

    I would be in favor of this, only if it cut down on the number of commercials I have to watch at all, but they’ll just fill it with something else that I will ignore.

    I say if people want to take their medical advice from a TV/print advertisement, then more power to them. Had I an ailment that was relevant to an advertised drug, I’d ask my physician about it over the phone or on my next visit. I don’t expect my doctor to call me about a new medicine when it becomes available, except perhaps for the more serious of medical problems. Though, if I were afflicted as such, I’d probably know about the drug well before the drug company marketing team decided to inform me.

    As a suggestion, when an article involving legislation is posted, would it be too much trouble to ask that the relevant links to http://thomas.loc.gov/ be provided so that politically minded types can further research the proposed law?

  20. ozraven says:
  21. adamondi says:

    Anything that removes commercials of horny old people from my TV watching gets the thumbs-up from me.

    It is definitely not a coincidence that the big pharmaceutical companies are fighting the two-year waiting period. After two years, there are usually generic alternatives to the big name brands of shiny new medications.

  22. facted says:

    @chael38: Direct-to-consumer advertising is not the same as patient/health literacy. It is drug companies force feeding patients information they want them to hear (e.g. not the negative studies that have been done on a drug ;) ).