Edwards: 2-Year Ban on New Drug Ads

How many are medicated to treat illness induced by %$#@ in their food? What's Prilosec but a way to force down what Nature tells your stomach is toxic? Keep those profits rolling whatever the public health cost.

That's a broad stroke that you're painting over a drug that is useful in treating many different diseases. I have friends who suffer from IBS and Crohn's, and a great uncle with ulcers who all find some relief using PPIs. But I agree with your sentiment. The pharmaceuticals will doing anything to raise profits.

Pure politics. DbyZ - I think you hit the nail on the head. To me the fact that there is a suggestion for a mandatory delay in advertising tells one thing: inefficient propagation of information.

Advertising is just a vehicle. Curbing it is like telling someone not to scratch an itch that may be caused by a deep internal disease. The main problem, I think, is in the fact that information distribution is not effective and it is financially reasonable for big companies to spend money on advertising. This should not be, but the problem should be addressed by improving information flows between big pharma and the doctors rather than cutting off circulation with consumers.

Introducing 2 year delay in advertising will cut people off from information who could greatly benefit from it. Clinical trials already take up a ridiculous amount of time - to require FDA approval for advertising and to introduce a 2 year delay would mean further increasing that time.

Or may be I am wrong. Perhaps with important drugs doctors are in the know and the only drugs affected will be the lower-end drugs that produce slight improvements in quality of life. Can someone shed some light on this?

NikitaB,

are you aware of just how little innovation there is at drug companies when they have a huge success with a new drug? All the R&D from that point forward goes into ways to change it just enough so that they can repatent it and charge a lot of money for it.

Currently there is no FDA requirement to test efficacy against competing drugs on the market. If you want to get the innovation moving, require efficacy testing against other competing drugs so patients and physicians can make actual informed choices.

BmS, drug companies are businesses - their job is to make drugs and make money to push forward and make more drugs. They are just tools and going after tools makes no sense although I agree with you that it sucks that they have no incentive to go after drugs that may be efficient, but can't turn into a "blockbuster" drug. It's a stick on two ends - if you force drug companies do more R&D, they will make less money and be less efficient at producing drugs.

I didn't know about the lack of FDA requirement with respect to competing drugs. I would imagine that, since clinical trials are very regulated and all drugs must go through the process, efficacy data can be gained from analysis of the clinical trials, can it not?

But you are right - there is definitely a problem in that the way research is done, things are far from optimal. The way to solve the problem, I think, may be to increase incentives to do drug development by reducing costs of clinical trials, marketing, research, etc. and thus allowing an increase in the number of smaller players thus increasing the competition.

The drug trials are published by the FDA, and there are non-profits working to publish comparative analyses of drugs based on those documents, but the question arises, should an anti-inflamitory drug that is as effective as ibuprofen but is new and under patent be considered for the market if there is no benefits over ibuprofen(such as serving a community that can not take Motrin due to allergy, etc)?

It is simply selling snake oil in the 21st century.

Perhaps there should be an FDA classification for drugs that are shown to be more effective than those on the market, a Classification that the companies can then use to sell their product to doctors. that would not restrict the production of new drugs that have no efficacy rating above any competitors, but it would provide an incentive to produce better drugs due to the prestige that the FDA classification provides in marketing the drug.

First I want to preface what I am about to write by stating that I am in no way an authority on what big phrama works on and am basing my judgement primarily on a very loose understanding of the situation.

BMS, the advantage of two patented drugs instead of one is the competition, which leads to reductions in price. Although even that is a moot point - drugs are a tricky thing and I am pretty sure that no two drugs are exactly the same. If a drug sells, there is a market for it and thus it is more effective in some cases than some other drugs... or so is likely. I doubt that any company says "let's make a drug that's identical to competition" - it makes no financial sense unless we are talking about generics.

Although I agree that it sucks that instead of seeking a major breakthrough, big pharma often has more incentive to make small improvements in existing drugs that don't really significantly affect our quality of life... something that no longer makes you drowsy, for instance, when there are people dying from HIV. But, again, you can't blame the pharma - they are just doing what is best for them.

I don't think that FDA or phrama are where the problem is. Again, I think it's more about information flows and creating incentives through the market for companies to change their strategies.

It is simply selling snake oil in the 21st century.

Perhaps there should be an FDA classification for drugs that are shown to be more effective than those on the market, a Classification that the companies can then use to sell their product to doctors. that would not restrict the production of new drugs that have no efficacy rating above any competitors, but it would provide an incentive to produce better drugs due to the prestige that the FDA classification provides in marketing the drug.

I follow the FDA and the pharma folks somewhat and think this is a brilliant way to transform the hyped high price sellers against the full range of options. It would be nice to have a side by side that say Rx drug for arthritis $16 dollars a day may cause stroke, bleeding, memory loss etc possibly death effectiveness rating 82%, generic ibuprophin, side effects few and rare and mild, three cents a day effectiveness 79%...then consumers have information to make a decision. Shoving people to ask for Rx's by self diagnosing in 30 second ads is insanity not medicine.

ps the edit thing isn't on right now in case you wonder why i didn't use it..

Why should FDA do this? All efficacy and side-effect information seems to be available - all you have to do is set up a site and you are in business, no? What does this have to do with FDA? Or are you suggesting that FDA should be responsible for organizing and presenting comparative information?

No... The data is available to do the analysis but you still have to actually analyize the raw data. The FDA is involved in this case only to offer recognition to drugs that are actually more efficacious than those already on the market.

Hmm. You know, this is where I can't respond. Don't know enough about FDA. But thanks for the comments - this made me think about some things that I didn't think about before.

From another angle, I notice there aren't many Wall Street guys in suits and ties getting hauled off to prison for snorting coke in the executive washrooms, although it's not because they aren't doing it.

Additionally, the war on drugs has complicated the treating of chronic pain. Pain is undertreated in this country in part because the docs feel the DEA breathing down their necks. Pain relief ought to be a human rights issue. Pain patients who have adequate pain control tend not to become addicts or abusers. Some old-fashioned notions need to be updated.

I think a consumer's and a doctor's ability to make an informed and educated descision about pescription medication is more important than a drug company's right to advertising.

Speech comes in categories. Political speech is completely free, but the supreme court has ruled that Commercial speech can be restricted.

"Free speech" nothing... these people are selling snake-oil.

All the advertising can do is have the person consult with a doctor who then makes an educated decision whether to prescribe the medication or not.

I think a consumer's and a doctor's ability to make an informed and educated descision about pescription medication is more important than a drug company's right to advertising.

How does advertising prevent that? Before a person can get a prescription a person must still consult a doctor. If the doctor is good he will evaluate the drug and decide what is appropiate for the patient.

Honestly, if Edwards wants to do something he should focus on how drug companies pressure and kick back to doctors to prescribe the drug

Honestly, if Edwards wants to do something he should focus on how drug companies pressure and kick back to doctors to prescribe the drug

What do you think all the advertising is for? To cause a lot patients to look for the latest high-fashion drug prescriptions.

What do you think all the advertising is for? To cause a lot patients to look for the latest high-fashion drug prescriptions.

I don't have a problem with that. If there is a drug out there that may help with a condition I have then why should it be an issue to ask my doctor if he thinks that drug is a good solution for me. For some people it may be the first time they relize there may be a treatment to a problem they have. I expect that my doctor will evaluate me, evaluate the drug, and make recommendation on what he thinks is the best course of action.

It would bother me though if my doctor wrote the prescription over something perhaps cheaper cause that is what the drug companies is paying them to do. Granted this is a trust thing between doctor and patient but I don't have a problem with eliminating an element that I as the patient do not know about.

The problem is, by advertising to the consumer, the drug companies are counting on the consumer questioning the doc if he prescribes an older, cheaper drug. "Why can't I have [new drug]?" Case in point is blood pressure medicine. The first line of treatment is diet and exercise. After that a simple diuretic is the drug of choice; these are old, generic meds that, well, they treat the patient adequately - but not so much the shareholder. If diuretics don't work, then the more advanced meds are called for.

Remember Sarafem? That was Eli Lilly's attempt to repackage Prozac and thus extend their hold on it as a non-generic drug. The race to get the most bucks before patent expiration leads to generics is the real battlefield. A two year ban would alter this momentum considerably.

The problem is, by advertising to the consumer, the drug companies are counting on the consumer questioning the doc if he prescribes an older, cheaper drug. "Why can't I have [new drug]?" Case in point is blood pressure medicine. The first line of treatment is diet and exercise. After that a simple diuretic is the drug of choice; these are old, generic meds that, well, they treat the patient adequately - but not so much the shareholder. If diuretics don't work, then the more advanced meds are called for.

If you have a good doctor s/he will explain why a particular treatment may be a better choice than jumping to the latest wonder drug. If your a good patient you'll listen to your doctor.

While I accept this as ideal circumstances I think the doc possibly getting benefits from the drug company complicates the issue more than advertising to the consumer.

People who want the latest & greatest drug will just doctor shop. They'll find some doctor who is willing to write a prescription.

OMG!!! There's a comment delay thingie! When did that happen?!?!?!?!?!?!?!

There is a ban on kickbacks.

I would like to see a real ban on kickbacks to doctors for pushing new drugs for the drug companies.

what the above meant was he would like to see the law ENFORCED

he knows that what I meant Chill. I have figured out that the Observer is a troll and likes to argue to get attention.

So why have additional laws, when the present adequate laws are not being enforced? Why would we believe the new law would be enforced.

Frankly, the Newsvine Kommies just accuse about kickbacks without any proof.

*clap* *clap*

They have no right commanding me to take these drugs.

I'm sorry that you are so weak willed, however free speech is far more important than your aesthetic revulsion at drug advertisements.

Yeah well, everyone says that advertising has no effect on them, yet the industry spends millions upon millions betting that they can. Someone isn't telling the whole truth.

"Ask your doctor" is commanding you to ask your doctor about the drug. It isn't commanding you to take the drug. It seems to me that if we're going to blame someone, it should be the physicians for being less than diligent in their prescribing habits. Rather than prescribing something to shut patients up when they go into offices, they should think about what they're writing and decide if it's really in the patient's best interest. This is exactly how we have our problem with the so-called "superbugs." Physicians prescribe before they think, just as they've been doing with unnecessary antibiotic agents.

To your point, More Than Happy, I agree that advertising to consumers certainly has an effect on marketing for the drugs. But I think it's less of an effect than we think it is for prescription drugs. Consumers can't obtain these drugs without a prescription, so all it's really doing is using the consumer as a reminder to physicians that yes, this drug is out there and available for prescribing. But I don't think it's quite the same as the direct marketing for products like over the counter meds. As far as the advertising goes, it's not the advertising itself that needs regulation. It's drug approvals by the FDA. Advertising for meds does undergo a very stringent review process, but I think drugs are getting approved much more quickly than they should. If the approval process is better, then the evidence in favor of an approved drug will be better, and the advertising will follow.

Entelechy,

Commercial Speech is not free.

Commercial Speech is not free.

So said the Supreme Court in a tortured effort to allow for bans on smoking ads. However my sense of justice goes beyond what nine people in black robes think. Does yours?

Do you have a reasonable argument why free speech should be restricted simply because a product is being sold? Why doesn't that argument apply to the selling of policy -- i.e. to political speech? Surely you're not going to argue that no one profits from pushing particular policies.

And once you're restricting political speech, then the First Amendment is essentially negated.

The ol' golden rule... he who has the gold makes the rules.

The golden rule has been slightly modified.

Being that gold is now irrelevent the rule is "they who collect income tax make the rules".

How do you figure? If there was a ban on general-public advertising, they'd all save in marketing costs.

Well because as a start-up I would have to allocate additional funding to support the company while waiting out the 2 year blackout to expire.

And with an assumption that my new drug might actually help people it would be a tragedy to have passed all the health safety requirement and yet still not be able to promote it's use.

Well because as a start-up I would have to allocate additional funding to support the company while waiting out the 2 year blackout to expire.

I still don't understand

yet still not be able to promote it's use.

But you can promote its use, doctors have trade publications that contain this type of advertising for learned audiences. What should be banned is advertising on TV to the general public, to an audience who largely has no understanding of organic chemistry.

...doctors have trade publications that contain this type of advertising for learned audiences. What should be banned is advertising on TV to the general public, to an audience who largely has no understanding of organic chemistry.

Most people in the general public see a drug ad and if they have that condition they want that prescription, even if an older and cheaper drug is just as effective. The purpose of drug advertising to the general public is to get the general public to request those drugs.

I think maybe he's saying that the actual ad campaigns would have to be approved be the FDA?

Picture this - standing there across a crowded room in Manolo's, shopping bags set down, at the slot machine with one hand on the lever and the other curled round a Dove bar, flashing come-hither looks to every passerby - somebody help him!