Is The FDA Helping Or Hindering Medical Innovation?
from the well,-that's-obvious... dept
Every time we talk about drug patents and the healthcare industry, without fail, someone shows up in the comments and makes the same simplistic claim: "you have no idea how much it costs to bring drugs to market!!!" Of course, that's arguing a slightly different issue, and it's important to break down what's being discussed. First of all, there's the question of how much does it really cost to bring medical innovation to market. There's a great book from a few years ago, called The $800 Million Pill, by Merrill Goozner, which debunks many of the claims about how much it really costs to bring a drug to market, which we noted recently has been updated in recent studies. What you realize is that (surprise, surprise) the pharma industry vastly exaggerates what it really takes to bring a drug to market. That's not to say it's cheap. It's not. But it may be an order of magnitude lower, and that makes a big difference. On top of that, a large percentage of the actual research budget comes from universities and is funded by the government anyway.But... the defenders respond, the big expense isn't always research, it's clinical testing. And, in many cases that's true. Clinical testing is quite expensive. But why is it so expensive? That's another area worth exploring, and you begin to discover all sorts of issues that suggest this is a case where government regulation can often do more harm than good. David Levine points us to an excellent piece by Carl Schramm at Forbes pointing out how the ridiculous level of controls by the FDA aren't just making this process crazy expensive, but it's also limiting medical and healthcare innovation. And for what benefit? Obviously, the initial response many have to this is that the FDA and massive expensive clinical testing is necessary to protect people from dangerous drugs. But there are serious questions about how effective the FDA actually is in doing that. The clinical testing process often focuses too much on performance against a placebo, and not one whether or not people actually get healthier. On top of that, we've see that the FDA often seems to focus on helping pharmaceutical companies, rather than helping keep people healthy.
Schramm points out that the way to drive innovation is through "messy" capitalism, where lots more players get to test a lot more things -- the exact opposite of what the expensive FDA process entails. And while the obvious retort is that this will create much more dangerous drugs, it's not clear that's necessarily the case:
In any industry within a free-market society, the innovative process works best when it is allowed to be "messy." Lots of people are constantly trying new things, starting new companies and subjecting them to the test of the marketplace. From the cauldron of this market testing a higher order emerges, and the march of progress ensues.Again, there are obvious problems with the way things were done a century ago. It doesn't mean we need to go back to that entirely, but at some point it should be realized that perhaps we're losing out on the cost side of the cost-benefit equation. Obviously, those making medical products have every incentive to have those products actually work. Rather than saddling them with massive clinical testing regimes, why not focus on transparency, that would provide more data and opportunities for everyone to properly evaluate the effectiveness and risks of certain products? As it stands now, the data from most clinical trials is totally hidden away. Imagine a much more open process that would allow people to access the data, share their own data and determine what really is and is not safe.
And so it was in the early days of the pharmaceutical industry. Before FDA control, which took hold in the years after the Pure Food and Drug Act of 1906, the market was largely without barriers. A pharmacist might bring forth Bromo-Seltzer, or Noxzema, or Coca-Cola, or little liver pills or laudanum. Market forces would then determine if the product had value. Only tort liability acted as a check on the manufacturer, and, interestingly, there were few lawsuits.
Although extravagant claims were often made for "patent" medicines, the consumer was presumed to have common sense and to undertake some risk in all things. It was also presumed that manufacturers would follow high standards if they wished to stay in business, and indeed many firms and products from that era are still with us today. The Smith Brothers were trusted to make cough drops in a clean factory with good ingredients. Johnson & Johnson became a trusted name -- as did Eli Lilly.
Andy Kessler's excellent book The End of Medicine does a nice job highlighting how the FDA's process is also so focused on drugs rather than actually making people healthy that it has created massive stifling effects on non-pharma medical advances. The book highlights all sorts of technological health care advances that could bring the same sort of computer/technology revolution to healthcare (making things faster and cheaper at an exponential rate), but so much of it is stifled by the FDA clinical trial process, meaning all sorts of useful products never actually make it to market.
And while I'm sure I'll face accusations of this in the comments, I am not saying that we should just wipe out the whole FDA process. I'm just suggesting that perhaps it's time to rethink how it works and what the real costs and benefits are... and if there might be a better way that is cheaper and actually encourages much more medical innovation.
Thank you for reading this Techdirt post. With so many things competing for everyone’s attention these days, we really appreciate you giving us your time. We work hard every day to put quality content out there for our community.
Techdirt is one of the few remaining truly independent media outlets. We do not have a giant corporation behind us, and we rely heavily on our community to support us, in an age when advertisers are increasingly uninterested in sponsoring small, independent sites — especially a site like ours that is unwilling to pull punches in its reporting and analysis.
While other websites have resorted to paywalls, registration requirements, and increasingly annoying/intrusive advertising, we have always kept Techdirt open and available to anyone. But in order to continue doing so, we need your support. We offer a variety of ways for our readers to support us, from direct donations to special subscriptions and cool merchandise — and every little bit helps. Thank you.
–The Techdirt Team
Filed Under: clinical trials, fda, medical innovation
Reader Comments
Subscribe: RSS
View by: Time | Thread
Why?
Quit advocating piracy...I mean...quit advocating counterfeit drugs...I mean...stop producing child porn...
[ link to this | view in chronology ]
Re: Why?
[ link to this | view in chronology ]
Re: Why?
[ link to this | view in chronology ]
I will: Let's get rid of the FDA.
[ link to this | view in chronology ]
How about two for the price of one? Let's get rid of the USPTO at the same time.
[ link to this | view in chronology ]
Re:
[ link to this | view in chronology ]
Re:
FDA used to be about making sure the drugs didn't kill people, as if that's somehow a successful business model, but now drugs must also pass an effectiveness test.
Also, how many people does the FDA kill by not allowing drugs to the market? Has anyone done any studies on that?
[ link to this | view in chronology ]
Legal recourse
[ link to this | view in chronology ]
The other side of the pharma business.
Most medical procedures now relate a cause to a pill. Many software programs are sold to hospitals for this sole purpose, and it's absolutely frightening.
If our medical community, backed by pharma, has a role only to make us comfortable rather than curing our ill, I'll take my financial freedom to enjoy my last days than I will giving it to a system killing me.
Let's see someone debunk this report, if they can.
[ link to this | view in chronology ]
Re: The other side of the pharma business.
Of course before they can decide which option to charge you for, they have to run you through as many tests as your insurance company will allow.
Never forget, as well meaning as doctors are, they have been essentially brainwashed by the AMA and pharmacutical reps. You thing the health care industry is there to cure you? No, it's a multi billion dollar industry run by large corporations (pharmacutical, HMO's, hospital conglomerates, not to mention GE and other medical equipment manufacturers) who all have shareholders and are seeking to maximize profits. Healthy people are their worst nightmare.
[ link to this | view in chronology ]
[ link to this | view in chronology ]
I'll say it!
[ link to this | view in chronology ]
Re: I'll say it!
[ link to this | view in chronology ]
Re: I'll say it!
[ link to this | view in chronology ]
Re: Re: I'll say it!
On the other hand, I think there is room to loosen up the trial process to make it more competative and even a little faster. IMO, the key to that new process would be the most honest disclosures the testers can make. A means would have to be developed to let all the subjects* know the possible risks for taking the drug, and be updated on those risks as time goes by and more knowledge is obtained.
*Yes I know that not everyone may be taking the actual drug, but unless psychology says otherwise, giving everyone the same information ought to make sure that those who are, are informed.
[ link to this | view in chronology ]
Re: Re: Re: I'll say it!
Why do I feel old knowing the origin of calling a doctor a quack was from giving quick (quicksilver, aka mercury)
The world is a horrible place and there will and always be forces that want to kill you but the answer is not to ask some higher authority to resolve your issue. Look to the person next to you and you may just get somewhere.
[ link to this | view in chronology ]
The FDA does good work
Among it's *11* acknowledged life threatening potential side effects is spontaneous rupture of the spleen.
Read that again: Spontaneous rupture of the spleen.
The FDA approved a drug which can make internal organs explode without warning.
I remember seeing this drug widely advertised on TV: "Ask your doctor if Neupogen is right for you..."
http://www.surveyorhealth.com/meds/drug-info/Neupogen/8834
[ link to this | view in chronology ]
Re: The FDA does good work
On the question of spleen rupture: almost any drug (or other therapy) has some potential side-effects. Then again, not treating many conditions may also have side effects -- or just "effects". So you need to weigh the risks of treatment vs. the risks of no treatment (or of other treatment, if available) and make a choice.
Consider this. Just going outside on foot or bike or car carries some risk of getting involved in a traffic accident. This sort of trauma can and sometimes does result in a spleen rupture. Knowingly or unknowingly, we decide whether to take that risk all the time.
Lastly, if it weren't for FDA regulation, we probably wouldn't know nearly as much about potential side-effects. This would not necessarily be better.
Of course, the FDA, like anything, can be improved to better protect patients while ensuring they can be effectively treated for disease and injury.
[ link to this | view in chronology ]
Re: Re: The FDA does good work
For one thing, it'd streamline air travel security down to 2 prominently displayed posters...
"Warning: Could Go Boom"
"Warning: Could Fly Into Buildings".
[ link to this | view in chronology ]
Re: Re: Re: The FDA does good work
I can't decide if this is insightful or funny.
[ link to this | view in chronology ]
Re: Re: The FDA does good work
I see you believe in fairytales
[ link to this | view in chronology ]
The current "cause" is tort reform (and in some places, firmly in place)next, get rid of regulation? So we are to expect pharma execs to just be nice guys and protect the public? Does that work with Wall Street? Oil companies? Anywhere?
Sure, most companies would do ok, but what harm could the others do, especially considering under the current system, companies still get hammered by the FDA.
Without the FDA, who is to say there is actually clinical data for the public to review? Why do the tests?
It would be nice if we could eliminate the FDA (something drug companies would love) but I bet their actual profits would go down because other countries wouldn't let their products on their markets.
[ link to this | view in chronology ]
Misleading Topic
Which includes food and cosmetics,in addition to pharmaceuticals. But your last line says "there might be a better way that is cheaper and actually encourages much more medical innovation." which is NOT the purpose of the FDA. I think you might have good points to make on changing the FDA to actually encourage innovation (if only in the medical department), but since innovation is not part of it's current directive it would be inaccurate to measure it's effectiveness on that standard.
Perhaps I'm wrong, and while I am certainly no expert of the FDA, I think it is specifically set up to place the prohibition of unsafe goods at a higher priority and ignore the cost of the regulations almost entirely.
[ link to this | view in chronology ]
Re: Misleading Topic
* Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
* Protecting the public from electronic product radiation
* Assuring cosmetics and dietary supplements are safe and properly labeled
* Regulating tobacco products
* Advancing the public health by helping to speed product innovations
* Helping the public get the accurate science-based information they need to use medicines, devices, and foods to improve their health
[ link to this | view in chronology ]
The reality is simple: There are no absolutely safe drugs (hey, you can hurt yourself with a band aid!) and there are no drugs without any side effects (even placebo has a few).
But that does not deter people from taking Aspirin (stomach bleeding?), Tylenol (Liver failure?) and quite a few of others. Are those drugs absolutely safe? No! Then why do people take them? Probably, because they help an absolute majority.
Now, about the horrifying list of side effects on newer drugs. It�s a simple liability issue. Evil Pharma MUST disclose ALL side effects, regardless whether they are caused by the drug, or not. In fact, it is too costly to figure out if the tested drug is a real cause or not. Hence, if you take a closer look at the actual occurrence of those horrific side effects, in most cases they will be BELOW 1 present of total population tested. In plain terms, if some poor schmuck got in a car accident and ruptured his spleen while being a part of the clinical study, there is a good chance that �spleen rupture� will be on the list of side effects. Does it makes sense? No. Can it be a reason to prevent a frivolous law suit � you betcha.
So, he did we get here? Simple answer � idiotic law system and overall society desire to always blame somebody for their own mishaps. Plus pure greed which works all that well with current legal system.
[ link to this | view in chronology ]
Add the PDUFA to the list of FDA actions hindering progress
[ link to this | view in chronology ]
Too bad those 99% of employees work for their evil bastard bosses that make up the other 1%
[ link to this | view in chronology ]
Consistency, anyone?
[ link to this | view in chronology ]
[ link to this | view in chronology ]
[ link to this | view in chronology ]
Thanks for share
[ link to this | view in chronology ]
Thanks info
[ link to this | view in chronology ]