Now you're getting it.

 

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how much of that money is spent convincing the public that they have a disorder which requires this new drug of theirs?

 

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Thanks for replies.

Eager kinda was on the same track as i was, it just seems that lately there are more drugs advertised that make say "Geez, the adverse effects sound worse than the positive ones. I'd rather suffer with <insert ailment here>.

Plus alot of them seem kinda laughable on the surface - eyelash growing, restless leg syndrome, 'get your period only 3 times a year instead of 4! but there's also a chance it will kill you" kinda stuff, but most of those are for the non-ailment type off stuff.

Then you see the lawyers hawking lawsuits for dozens of drugs. Added all together, it kinda makes Pharma look a little bad.

Kinda made me wonder, so i thought i'd ask for more info, which you provided.

Question though - is it true that they have to put a disclaimer if they had one incident, no matter how many subjects took it? Meaning, it could be one in a million odds, but they still have to say "Could result in death, dismemberment or turning into a zombie"? Seems it would be fairer to allow them to state the 'odds', because otherwise people could assume much worse.

 

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OK well that question's got a kind of complex answer too.

I will start off by saying that first and foremost: the ways in which pharmaceutical companies can advertise and the things that they can say in their advertisements are strictly regulated and a typical pharmaceutical company's ad is drawn up not JUST by marketing folks but by folks from the company's Regulatory Affairs and Legal departments as well.

I spoke earlier about how pharmaceutical companies aren't really allowed to make straightforward statements about efficacy and/or indications such as "If you have high blood pressure, this drug can help you!". The reason for that is that such statements might not actually be true - not because the drug doesn't treat high blood pressure, but because the drug may not treat ALL types of high blood pressure. That's why instead, pharmaceutical advertisements will say "Ask your doctor is this drug is right for you."

Now with respect to the side effects, the FDA has a mandate out there to pharmaceutical companies that says that companies must reveal all of a drug's side effects, even if a clear causal relationship cannot be determined between the drug and the observed adverse event. Many of these adverse events are observed during clinical trials and are known prior to the drug being approved for sale. However, because no clinical trial can effectively predict or encompass all of the possible adverse events from taking the drug, pharmaceutical companies are required to do post market surveillance and continue to collect information and reports of adverse events about their drugs long after those drugs have been approved for sale. So, say if suddenly some group of people taking 3 other drugs that didn't exist when drug A was approved and all of a sudden, the combination of these 3 new drugs with drug A creates some adverse condition. Those events have to be reported, the drug's label has to be updated (that's a whole big issue there - labeling, branding, and package inserts) and physicians and pharmacists need to be made aware of the possible negative interaction and so on and so forth... there are many other types of adverse events that may come to light after approval too...

You still with me here?

Now of course, there's the whole litigious thing. Drug companies don't want to pay skeezy lawyers any more money than the rest of us do, so as part of their own CYA measures, whenever they hear about a new possible adverse event, they throw it on the label and let people know about it - this way at least they can say that patients and physicians were warned.

Obviously, depending on the seriousness of the adverse event, drug companies have obligations to report them to the FDA (and other regulatory agencies in other places where they might sell the drug) and that gives regulatory agencies an opportunity to force a withdrawal of the drug and/or order further testing or what-have-you. However, if serious adverse events start legitimately showing up during post market surveillance, no drug company is going to make the FDA tell them to stop selling the drug... but that safeguard exists anyway.


NOW it gets even more interesting because you and everyone else has noticed how this endless list of side effects seems like ridiculous overkill. The FDA has even gone so far as to state:





This doesn't quite jibe with FDA's other mandate of reporting all of the drug risks even if a clear causal relationship between the drug and the observed adverse event cannot be determined...

If that looks like US government branded doublespeak to you, welcome to the club, because that's sure as hell what it is.


So to sum up, the reason you see such underwhelming claims about what a drug can do in advertisements is because drug companies are very strictly regulated about what they can say and in essence, they are not allowed to make straightforward statements per FDA mandate about what a drug can or cannot do.

Also, the FDA wants drug companies to report all the drug's risks even when they can't be sure the drug is the cause.

Also, drug companies want to protect their own asses from the lawyers and lawsuits through full disclosure.

Finally, the FDA is now saying "well we didn't really mean that you had to report EVERYTHING, we just want to warning letters and go and get consent decrees if you don't report adverse events that WE think you should have reported.

 

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The problem we seem to have is many take their view of drug companies from Hollywood. It is fun to have a drama about the evil people bring a bad drug to the market with the hero fighting the odds to stop it. In real life this never happens. Hollywood would be harmless if people understood it is just a story. Sadly some people cannot tell the truth from fiction, so they go with the best story.

 

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JFC Cawlin did you just do a hit of meth?

DAYUM that's a lot of letters n words n stuff.

 

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Well I type quickly and yes I've worked in this industry for almost 20 years but I didn't type all of that in one breath or anything!

 

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Well i read the whole thing, it isn't often i'm genuinely interested in something written on the Outpost, so congrats on that!

Leave it to Fist though to follow it up with complete, unrelated nonsense.


Last question: So how does the consumer tell the wheat from the chaff in all those warnings? I'm assuming our doctors aren't going to be able to answer off the top of their heads, but do they have access to detail?

 

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Well that's a very good question. In truth, it's at the heart of FDA's admonition to pharma about reporting every little thing...

In the end, again, the FDA wants your physicians to be prescribing medications for you, NOT the drug companies and NOT the FDA.

Most physicians have a lot of "industry" information to keep up with themselves. They will consult with other physicians, receive reports and therapy updates and so forth through the AMA and other professional organizations about optimal therapies and about new drug products and drug families and the various indications. But, even physicians have a hard time keeping up with all the risk/adverse event reporting and it is essentially up to their professional acumen as well as the various professional medical organizations to sort through the wheat and the chaff. This is a continuing part of a physician's annual work load on top of dealing with patients and possibly the fiscal and personnel management of their office/clinic. They're busy people who work very hard, and who have to sift through ENORMOUS amounts of information in order to do their own jobs competently - remember lawyers are waiting around every corner to sue a physician for malpractice as well.

Consider all the "directives" or "goals" surrounding this issue:

One goal is to provide optimal, safe, pure, effective therapies for disease to the patient - this is shared by FDA, physicians, and pharma.

One goal shared by all parties is to provide physicians healthcare professionals with the information they need to make decisions for their individual patients.

One goal of pharma is to keep the FDA from coming in and shutting down the pharmaceutical company.

One goal of pharma is to keep the lawyers from suing the siht out of the pharmaceutical company.

One goal of the physician is to keep the lawyers from suing the siht out of the physicians.

An additional goal of the FDA is to keep physicians in the role of prescribing and to make sure that pharma is acting appropriately and within the law.

I will admit that I am unsure of why so much marketing is directed towards patients for various drug therapies - the physician is only going to prescribe what they can professionally stand behind - how often have you gone to your Dr. and successfully demanded a particular prescription against the Dr.'s judgement?

I tend to not actually pay much attention to the advertisements I see on TV for pharmaceutical products because a) I don't watch a great deal of TV, and b) because I work in the industry in quality assurance so marketing stuff is of little concern to me and I am surrounded by it and information about drugs every day, all day, all year to the point that I am somewhat numb to it.

In the end, I don't have a good answer to you for how the consumer is supposed to sort it all out. There are many priorities here, some of which compete, all of which have strong motivation behind them.

I would suggest that in the case of "lifestyle" drugs, as a consumer, you're on your own with those - if it's not truly "medically necessary" well I guess you owe it to yourself to try to educate yourself as much as possible - and that includes speaking to your physician about your concerns over side effects vs. efficacy in order to make a decision.

There are counterindications for even drugs like viagra and the other ED drugs out there that a responsible physician should pay attention to. If you go and get those drugs without a prescription, well, you're on your own...

I'm sorry I don't have a better answer, but clearly you can see the liabilities associated with changing things. If pharma stops reporting every little adverse event, the FDA could find them in violation of its own mandates and pharma could find themselves getting sued by opportunistic lawyers or worse, find themselves under consent decree from the FDA.

As a side note, consent decree means basically that FDA sets up shop AT your facility and oversees personally every little aspect of your operations and suspends your license to distribute without case by case approval of each and every product in some cases - this is rough in the short term on a pharmaceutical company and can be either very good in the long term since it results in better overall quality, or can be very bad in the long term since it results in lower sales and the company's financial position weakening to the point that they are bought by another company.

Meanwhile, the FDA doesn't want to back off on their mandate to report everything because they will feel as if they are not meeting their own responsibility to the citizens of the US if they do so, but of course they see how confusing it is becoming with all the reporting going on for both the consumer and the physicians...

In truth, what is needed is some sort of clearer guidelines about what must be and need not be reported and in order for that to have any weight, there has to be a guarantee against being sued, or pharma is going to keep on covering their asses. Typically compromises such as this are achieved with a corroboration between the pharmaceutical industry and FDA, but that doesn't usually happen until the "doublespeak" phase has gone on for a while - we're still in the "doublespeak" phase right now.

I hope all that makes sense.

 

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