Andy Grove on Reforming the FDA

by on October 1, 2011 at 10:52 am in Economics, Law, Medicine | Permalink

In an important editorial in Science, Andy Grove, former Chief Executive Officer of Intel Corporation, advocates restricting the FDA to safety-only trials. Instead of FDA required efficacy trials patients would be tracked using a very large, open database.

The biomedical industry spends over $50 billion per year on research and development and produces some 20 new drugs….A breakthrough in regulation is needed to create a system that does more with fewer patients.

While safety-focused Phase I trials would continue under their [FDA] jurisdiction, establishing efficacy would no longer be under their purview. Once safety is proven, patients could access the medicine in question through qualified physicians. Patients’ responses to a drug would be stored in a database, along with their medical histories. Patient identity would be protected by biometric identifiers, and the database would be open to qualified medical researchers as a “commons.” The response of any patient or group of patients to a drug or treatment would be tracked and compared to those of others in the database who were treated in a different manner or not at all. These comparisons would provide insights into the factors that determine real-life efficacy: how individuals or subgroups respond to the drug. This would liberate drugs from the tyranny of the averages that characterize trial information today. The technology would facilitate such comparisons at incredible speeds and could quickly highlight negative results. As the patient population in the database grows and time passes, analysis of the data would also provide the information needed to conduct postmarketing studies and comparative effectiveness research.

Grove cites Boldin and Swamidass and especially Bartley Madden’s important book, Free to Choose Medicine, as inspiration for this proposal. By the way, I also recommend Madden’s book very highly (I am also proud to note my bias in this regard).

I have long advocated restricting the FDA to safety only trials (see, for example, FDAReview.org and my paper on off-label prescribing) and it seems that this idea, once considered outlandish, is now rapidly gathering advocates.

Addendum: Derek Lowe offers useful comments (see also Kevin Outterson below). One point that I think the critics miss is that nothing in Groves’s proposal and certainly not in Madden’s proposal which is somewhat different or in anything that I have advocated precludes randomized clinical trials for efficacy. Indeed, I strongly support such trials and have argued for greater funding so such trials can be done not by the pharmaceutical companies but by more objective third parties.

Highgamma October 1, 2011 at 11:19 am

So, no more placebos? Color me leery.

By the way, we’d better have every “marketing” relationship with doctors recorded in a big, open database as well.

Cliff October 1, 2011 at 2:54 pm

Read the addendum!

Jonathan c October 1, 2011 at 11:19 am

Hey Tyler can you comment some on dtca. Cause the FDA does have a role there too. I have done extensive research on the subject but would love your input/thoughts.

The fdas role after drug approval should be considered as well. I’m also unsure how familiar you are with the ftc’s role on OTC drugs such as weightloss aids. But the two forms of regulation are very different FTC(industry friendly) FDA more regulatory heavy.

Kevin Outterson October 1, 2011 at 11:33 am

Grove’s proposal is to conduct the efficacy trials in the population, with every patient enrolled. Registries are a good idea, especially to identify small safety risks, but they can’t prove efficacy since you’d lack the IV of randomization. This proposal ends double-blind placebo-controlled trials. There are other ways to address the “tyranny of the average” – see Anup Malani’s work on subgroup analyses, for example.

Brett October 1, 2011 at 11:45 am

This system as described would be much, much worse than the current system. Kevin’s right that lacking placebo controls is a big deal; every single case in the database would have some sort of selection bias — getting a large sample size and having subgroups tells you nothing about why someone got the treatment in the first place. And would physicians pay attention to peer-reviewed articles and reviews identifying the best treatments for specific groups, or just run their own analyses? I think there would be a lot of the latter, which is scary since many clinicians can’t even define selection bias or properly interpret statistical tests. The current system is bad, but this one would move us even further from any sort of evidence-based medicine.

Jamie_NYC October 2, 2011 at 9:44 pm

I could never understand why a lack of patients taking placebos is a big deal – I actually think it’s inhumane to give people sugar pills if they have a deadly disease for which we may have available treatments.

We already know the progression and other statistics for the disease (unless it’s a completely new disease, which is very rare). The only difference between the patients under the existing drug regimen and new patients (taking the experimental drug) is a possible placebo effect. However. Did anyone ever show that the placebo effect can change the outcomes of stage four cancer? Acute heart failure? Kidney failure? Seriously?

mulp October 3, 2011 at 3:04 am

Those randomly given “sugar pills” have given informed consent, just as those randomly given the drug that might help, hurt, or have no effect have given informed consent.

So, how do you feel about giving someone with a terminal condition a drug that doesn’t help their condition?

Brett Keller October 3, 2011 at 3:46 pm

Jamie_NYC — that’s not how it works. If we have available treatments that are known to work, then those are the controls. You have to compare the new treatment against the current standard of care or else the trial is considered unethical (even with informed consent) because you’re denying people the best known care. The reason we do randomized trials is because we *don’t* know the new treatment is better than the old. If we really knew, it’d be unethical to test it. Trials also have safety monitoring committees that are unblinded so they (amongst other things, like watching for side effects) can stop a trial as soon as there is enough evidence to show one treatment is clearly better than the other. At that point you must start giving the better treatment to everyone.

And the idea that “The only difference between the patients under the existing drug regimen and new patients (taking the experimental drug) is a possible placebo effect” is only true if the two groups are identical to begin with. But they aren’t! — unless they’re randomly assigned! Ie, the main reason for randomization and blinding of trials is to get rid of that sort of selection bias (you give different drugs to people who are more or less sick, follow them differently, etc), not because of a placebo effect.

David October 1, 2011 at 11:53 am

There are NO safe drugs. They all have side effects of varying severity. Some drugs have a benefit that outweighs the safety issue. When FDA approves a drug, they say the balance of benefit to risk is favorable.

Suppose a drug causes fatal heart attacks in 1 out of 20 patients. If the drug is for toenail fungus, you would judge that to be unacceptable no matter what. If it is for end-stage renal cancer, you might think this was acceptable: but only if you have evidence that the drug actually helps cancer patients live longer or better lives. If the drug does no good, the risk is still unacceptable.

The idea that you can separate safety from efficacy is foolhardy.

The idea of “safety only” approvals has been tried, by the way. That’s more or less how they do it in Japan. In practice, there are many fewer approvals in Japan than in other developed countries. The regulators end up setting such a high bar for safety that few drugs can pass it.

Dan Weber October 1, 2011 at 2:04 pm

I agree that “safety only” is a false hope. Let’s say a drug doubles your chance of heart attack but halves your chance of breast cancer. Should the FDA approve it? Lots of people shouldn’t take it, but lots of people could also benefit from it.

I think the FDA should be in charge of making sure the studies are run honestly and all results reported, but not really saying whether something is “safe.”

Rebecca October 13, 2011 at 5:54 pm

Couldn’t the definition of “safety” come from the existing system where a drug that gets past phase 1 is considered safe?

Ed October 1, 2011 at 12:27 pm

Groves’ proposal seems very similar to the way vitamins/nutraceuticals are handled today, which isn’t very efficient.

For an additional perspective, which is somewhat supportive yet skeptical:

http://pipeline.corante.com/archives/2011/09/28/andy_groves_idea_for_opening_up_clinical_trials.php

Drug discovery/development is rapidly progressing towards genetically defined patient populations. One would have to work this in very carefully so that a new drug for say, oncology, once determined safe, could be targeted towards the small subset of patients with the relevant translocation or mutation. Why take the drug otherwise if you wouldn’t benefit from it? But allowing people to take it who wouldn’t benefit would artificially distort the results to being non-efficacious.

Richard October 1, 2011 at 12:41 pm

As a health professional, I would caution on the difficulty of limiting testing to “safety only”. While it sounds good, the reality is that safety is a focus of every part of the FDA’s current approval chain. Sometimes side effects don’t become obvious until we increase the n. Sometimes there are strange interactions with other rare meds that don’t show up until the drug is on the mass market.

Without efficacy trials (esp head to head trials), most physicians would be leery of prescribing a new med over an established and cheaper one. You would have a hard time generating enough data for the database as a result.

MAS October 1, 2011 at 12:45 pm

Besides the problems with this proposal already enumerated above, I would stress the demise of “double blind” trials. The same doctors who choose the medicine to prescribe will be the ones evaluating and reporting on the outcomes for the database. This will almost certainly lead to bias in the reporting. A doctor who does not a priori believe in the effectiveness of the drug will not prescribe it in the first place. That makes him/her more likely to find a positive outcome.

Andrew' October 1, 2011 at 1:05 pm

When genetic individuality is elucidated this will be a necessity. In fact, we will probably just end up with a single database that will be called biochemistry.

Bill October 1, 2011 at 1:08 pm

Following up on Mr. Groves comments, I think Intel computer chips should not be inspected, and new chips should be put out on the marketplace to see if they are compatible or incompatible with other systems.

We would create a database of chip designs and those chips that did not show errors would be those which the market would assign a high value to.

I think we should first design the chips for a pacemaker this way, and volunteer Mr. Grove an opportunity to be first.

Bill October 1, 2011 at 1:15 pm

Instead of a chip, maybe it can be an all metal hip: metal hips failing at an alarmingly high rate:

http://www.nytimes.com/2011/10/01/health/01hip.html?_r=1&ref=business

Cliff October 1, 2011 at 2:53 pm

Huh? Is there a federal law requiring Intel to test their chips, or do they do it voluntarily? Because I do not see anyone proposing a law to ban efficacy tests.

Andrew' October 2, 2011 at 5:12 am

Bill, you have an almost good analogy.

The problem is that computers are pretty much the same and in aggregate respond the same to computer chips whereas people are different and in aggregate have a high degree of variance in side effects to drugs.

We already test people in the population, we just keep the size relatively small. Every now and then a drug passes that then gets released generally and still causes lots of problems and is ineffective in some people.

We are playing a game of make believe where we assert that people respond the same to drugs and we don’t have to do large scale tests in the population to determine safety and efficacy, so we rename the same to make us feel better about it.

Turkey Vulture October 1, 2011 at 1:23 pm

I think we’d be better off as a nation with fewer hurdles in the way of getting a drug to market. But like a commenter above, I don’t see how safety and efficacy can be disentangled. A drug with only slight side effects but no chance of working is worthless, while a drug with sometimes-deadly side effects that has some chance of beating back late-stage cancer may be incredibly valuable.

ezra abrams October 1, 2011 at 1:45 pm

you know how economists feel when people say really, really stupid things cause they havn’t spent a few hours reading intro econ ?
The reason the pharma industry doesn’t make many new drugs is because we don’t actually know a whole lot about the human body.
True we know a huge amount more then just a few years ago, and compared to say 1960, our knowledge is just incredible.
HOwever, we know very little compared to what we need to know to make drugs well.

As to the idea that we do efficacy instead of efficacy and safety..Mr Grove doesn’t understand pharmacology 101.
All drugs have some benefit and some risk or side effects; our tolerance for B/(R,SE) ratio depends on the disease. For aggressive cancers, we tolerate a low ratio; for a runny nose, we want a high B/R ratio
If you don’t know efficacy, all you know is risk, so how do you decide if it is worth it ?
Grove seems to propose that we use large large numbers of people as guinea pigs; sorry , you got a drug that has no efficacy whatsoever, but causes heart attacks.
And in the profit driven cut throat world of pharma, yeah, that databasey thing, hows that workin for ya ?

And the idea that we can track people randomly: think about that one; if people aren’t assigned randomly to control groups, how do you know you have efficacy ?????

jpa October 3, 2011 at 4:27 pm

if we are learning more every year, why is the rate of new drug introduced going down every year?

egl October 1, 2011 at 1:48 pm

Phase I trials often don’t do much to establish safety since the patients are typically healthy “normals”, doses are selected to establish maximum tolerated doses and pharmacokinetic properties, and the duration is short. For drugs that will be taken over a long period of time by sick people, you will need something that looks like a phase III trial with large numbers of patients and careful statistical design to study safety.

That said, getting the FDA out of the efficacy business might be just what we need to rescue the struggling pharma industry. They already know how to market drugs, so cutting r&d expenses could be just what the doctor ordered. As a bonus, it would be nice to stop hearing about the r&d productivity crisis in pharma: there would be no shortage of approved drugs under this system.

steve October 1, 2011 at 4:22 pm

As a physician, I see the need for lots of data entry. Who will pay me for doing all of this work? How do I choose which patient should get a drug which I think might be safe, but I have no idea if it actually works? Maybe Mr. Grove has a very large family he would volunteer? When I prescribe a drug not knowing if it works, and there is a bad outcome, how am I protected? Could this actually slow down the use of new drugs since given a choice between a drug that I know works and one whose efficacy is unknown, why wouldnt I always choose the known drug?

Steve

Andrew' October 2, 2011 at 5:17 am

“Could this actually slow down the use of new drugs”

Slow down relative to what? Relative to what people currently consider the starting gate (which may be delayed by years already) maybe. On the other hand, it may increase the incentive to create new drugs for diseases with poor drug coverage.

You should hope someone will pay you for the data entry. In fact, you will do it for free because if you don’t your patients will fill out the database themselves.

Jan October 1, 2011 at 4:44 pm

This system would provide no single, independent entity, like the FDA, to make decisions on drug efficacy. It leaves companies to compete on marketing, rather than effectiveness, which they admittedly do to a large extent already. Groves’ proposal would drive up the cost of health care even further by flooding the market with ineffective products that industry can push on prescribers. In addition, there is no political appetite now for a significant increase in federal funding of anything, much less something health care-related, like clinical trials.

Andrew' October 2, 2011 at 5:19 am

The current system creates a >$1B hurdle to even try a drug.

What happens is there is a new compound. The drug company has to make an educated guess (a $1B education, but still mostly a guess) what disease it might effect.

All Grove’s “system” is doing is acknowledge that a compound is just a compound. It doesn’ t care what our diseases are. Even its intended effect is in reality a side-effect.

ezra abrams October 3, 2011 at 1:18 pm

lets stipulate that the cost of a new drug is 1Bn (so far as I know, the only source for that is the industry funded tufts studys)
so what – it ain’t regulation, it is the poor state of our knowledge; for instance, we can’t predict, in silico, if a NCE (novel chemcial entity) will cause cardiac arrythmias, a major cause of failure in phase III trials.
We can’t predict which drugs will enter which cell types – you might need a drug in the liver, but get it in muscles
We don’t really know which splice variants are active…
etc

libertarian_adi October 1, 2011 at 8:00 pm

So many ignorant comments.

Watch and learn:
http://www.youtube.com/watch?v=dZL25NSLhEA

Quint October 1, 2011 at 11:21 pm

All unprovable counterfactuals and hypotheticals. No evidence here.

libertarian_adi October 2, 2011 at 12:43 am

http://www.cato.org/pubs/journal/cj5n1/cj5n1-10.pdf

I see that while you demand evidence for Friedman’s position–you fail to provide none supporting your topsy turvy position on the FDA.

J October 1, 2011 at 8:25 pm

How about having the FDA continue safety and efficacy studies as they do now, but strip them of the power to restrict what drugs can be sold or require prescriptions, and make them a purely advisory body?

“so such trials can be done not by the pharmaceutical companies but by more objective third parties”

Not saying pharma companies are necessarily objective, but it might be harder than you think to find parties that are any more objective than they are.

libertarian_adi October 1, 2011 at 8:32 pm

Here’s what really happens with the FDA: The pressure on the FDA bureaucrat, a rational agent pursuing his self-interest, is to always delay effective drugs. He would rather silently kill 10,000 people each year by delaying effective drugs than kill 2000 people by approving bad drugs, which would be minimal in a competitive market place. It was demonstrated with the Beta Blockers in the 70s which were approved after seven years, killing approximately 8000-10000 people each year. The number of lives lost due to lack of access to effective drugs (deaths which don’t make the news and ignored by consumer protection activists) is substantially more than the lives which would have been lost via bad drugs.

Here’s what happens in the free market: Bad drugs generate Class Action lawsuits and bad publicity, which drive bad firms out of business. It is in the self-interest of drug companies, in a competitive market place, to put out good drugs. Competition, self-interest, and Tort Law, will regulate the market much better than the FDA, which currently kills tens of thousands of people each year via drug lag. Furthermore, FDA over regulation creates monopolistic rules which drive smaller firms out of business and contribute to medical inflation.

I suggest that you all acquaint yourself with Public Choice Theory, a field initiated and revolutionized by Nobel prize-winning economist, James Buchanan. It holds that bureaucrats and politicians are as self-interested as the capitalists are and demonstrates that bad decisions made by the former group at a central level generate negative externalities which are far worse than market failures. If a private corporation imposes costs on us, we can drive if out of business by voting in the market place or by using the Tort system. If a central authority makes a mistake, the externalities are humongous and we have no way out. The FDA’s drug lag is a prime example.

Jan October 1, 2011 at 11:40 pm

I’m not sure I remember any class action lawsuit based on a drug simply not working. Medical device and drug companies kill tens of thousands of people each year, and that is with the current level of FDA oversight, which is severely hampered by politics and lack of resources. Vioxx alone killed an estimated 55,000.

Is the interest of an FDA safety officer really in delaying market approval of lifesaving products? Don’t negative publicity and professional accountability work both ways? “It was demonstrated with beta blockers” makes me think people are watching not just for ineffective products, but for delayed market approvals as well.

Who will develop the databases and perform the analyses necessary to produce the unbiased conclusions about the effectiveness of drugs necessary to let consumers and payers “vote in the market place”? Am I prepared to vote in the market place? I have an three undergrad classes in biochemistry. My doctor gets paid $1,500 per hour to speak on behalf of X Company’s products. We’re ready to make informed decisions, right?

libertarian_adi October 2, 2011 at 1:12 am

“Who will develop the databases and perform the analyses necessary to produce the unbiased conclusions about the effectiveness of drugs necessary to let consumers and payers “vote in the market place”?”

If you think the answer is the government, that institution with a monopoly in force, run by self-interested agents, then you are not paying attention. You can have private certification agencies which compete with each other for the best evaluations of drugs. Drug corporations “capture” governmental regulatory agencies and run them for their own benefit at the expense of the general public. Here’s a paper from George Stigler, an economist who won the Nobel prize in economics for his work in industrial organization: http://www.jstor.org/stable/3003160

His works justified the shut down of “captured” agencies like the Civil Aeronautics Board and the Interstate Commerce Commission — both of which had consumer “protection” activists and drone-like supporters who made dumb, economically illiterate arguments.

“Medical device and drug companies kill tens of thousands of people each year, and that is with the current level of FDA oversight”

This is actually an argument AGAINST the FDA. If you think the FDA is inefficient in regulating drug markets, then why bother supporting it? What are the costs of having the FDA? And what are the benefits? The FDA is currently a “captured” agency. Its costly requirements can only be afforded by big corporations, not smaller firms. This places fewer competitive pressures on corporations controlling an oligopolistic market. And FDA preemption shields corporations from future tort claims. The situation could not get more worse.

So, what do you suggest we do–more regulation?

Andrew' October 2, 2011 at 6:42 am

Vioxx? It was approved was it not? And it was voluntarily withdrawn by the evil corporation, no?

Okay, so let’s say you don’t blame the FDA for a failed approval instance, that the problem is not that the FDA is ineffective, but that it is hamstrung by a band of marauding libertarians who control everything in Washington.

It will always be convenient to conclude that the problem is not the FDA but that it is perpetually hampered political and short of resources. Then why not consider an alternative to the FDA?

Andrew' October 2, 2011 at 6:49 am

Another problem, why do we even need ever more NSAIDs? I suspect the current system is funneling efforts into well-worn paths, ironically with tragic results and what is the upside? Another NSAID. It also places inordinate emphasis (IMHO) on compounds and application diseases rather than discovering the full library of effects of all the compounds, not to mention the near infinite synergistic combinations. If you don’t question the fundamental system priorities, you probably aren’t going to recognize those as problems.

Jan October 2, 2011 at 8:04 am

Approved because its manufacturer buried critical safety data.

Jan October 2, 2011 at 8:07 am

Why do we need another NSAID? It was approved precisely because it was supposed to be safer than the others on the market. Even under Grove’s proposal, FDA would retain its safety role–but it can’t exactly do that if companies hide data pointing to concerns about increased risks.

Jan October 2, 2011 at 8:29 am

Private certification agencies funded by who? By me? Does my doctor chip in? What about my insurance company, it loves spending money. What happens when a certification agency misses something big and doctors find out they’ve been prescribing an ineffective cancer drug for five years? The market?

I don’t think the FDA is perfectly efficient, but with the shear volume of the products it regulates and the illegal practices of the industry (off-label marketing, kick-backs for overprescribing, withholding data, the largest criminal fines ever paid) some incidents do occur. I am all for a more independent FDA. But with the constant shrill calls for elimination of any government regulation, it makes it almost unthinkable that appropriators would give FDA enough resources (FDA was 0.37% of the HHS budget in 2011) so that it could stop charging industry application fees.

The FDA doesn’t shield corporations form tort claims, that’s the Supreme Court. And absent the FDA, they would be happy to find some other justification for stifling lawsuits against corporations.

guffaw October 1, 2011 at 10:16 pm

“Here’s what happens in the free market: Bad drugs generate Class Action lawsuits and bad publicity, which drive bad firms out of business. It is in the self-interest of drug companies, in a competitive market place, to put out good drugs. ”

Oh please. People like you with pie-in-the-sky proclamations make me ill. Here is what happens in the real world:

- We have an already-clogged court system. Class action suits take years upon years to form and then litigate.
- Up until that time, any ill-intentioned firm will have banked and will be able to continue to bank whatever monies it can from its deleterious drugs.
- Senior management and investors will have already bled the profits out of the company with inflated pay and benefits.
- Class action suits, if successful (and I suspect courts are more often than not reticent to financially cripple large companies) return pennies on the dollar to those done wrong. The aggrieved never, ever recover what they have lost. And CEOs almost never do jail time nor are they even fined. Case in point: any Bear Stearns or Lehman execs fined or forced to do the perp walk? Is there a more blatant recent case of intentional fraud off the top of your head?
- In any event, the company has been already been pillaged by those in charge who, by this time, have already set up another shop in another state under another name.

Just, stop with the nonsense.

Andrew' October 2, 2011 at 6:25 am

Here is the thing guffaw, a court system is utilized as-needed while bureaucracy is a constant presence. Increasing the capacity of a court system is nearly by definition a cheaper way to go than for a regulatory body.

You can’t blame people who want a robust tort system for the lack of a robust tort system.

Andrew' October 2, 2011 at 6:27 am

In fact, it’s interesting that you bring up banks. If I didn’t have a very strong belief in government incompetence, I’d almost think they are doing a bad job on this stuff to ensure people are constantly afraid. They keep doing crap, but they make sure it’s never quite effective enough to work. Kind of like the war on terror.

guffaw October 2, 2011 at 4:30 pm

What classifies as perfect logic in libertopia:

Agitate for a free market with mediation but ensure first that that remediation isn’t viable in practice.

Here’s a suggestion. If you propose a major change in procedure, it’s on you to ensure that procedure actually works from soup to nuts.

libertarian_adi October 2, 2011 at 12:35 am

“People like you with pie-in-the-sky proclamations make me ill.”

I hope I don’t make you severely ill that you would require advanced medication, which might be approved by the FDA only after you die.

“Class action suits take years upon years to form and then litigate.”

Certain class action lawsuits might take years; for example, cases involving legal complexities: The Cendant corporation was hit with a Class Action lawsuit by its investors in 1995 for securities fraud and creating false profit statements. The case was settled in 2000, with the Vice Chairman Kirk Shelton, in addition to being sent to jail, being ordered to pay $3.27 billion to its investors. Eventually, the corporation was shut down. This is a prime example of case with high legal complexities taking five years. A case involving well-documented ominous effects of a single drug will take substantially less time. Also, after the FDA is abolished, tort law reformed, you will have a true free market in which each firm would face high competitive pressures to avoid bad publicity and law suits: their rational choice would be to put out good drugs This is definitely not the perfect system. However, the monetary and human costs to the average consumer would be substantially lower. For example, the FDA’s seven-year delay of the approval of Beta Blockers alone killed in excess of 70,000 people–more than all deaths from U.S. drug disasters combined. Here’s the research paper which analyzes the FDA’s approval patterns: http://www.cato.org/pubs/journal/cj5n1/cj5n1-10.pdf

“Up until that time, any ill-intentioned firm will have banked and will be able to continue to bank whatever monies it can from its deleterious drugs… Class action suits, if successful (and I suspect courts are more often than not reticent to financially cripple large companies) return pennies on the dollar to those done wrong. The aggrieved never, ever recover what they have lost. And CEOs almost never do jail time nor are they even fined.”

Huh? I see you are the typical, left-wing ass clown whose analysis of a complex situation doesn’t employ economic reasoning, but the typical “CORPORATIONS ARE EVIL” rhetoric you learned from trolling on the Huffington post. I note that you haven’t provided any sources for your assertions regarding the FDA and are now going off with your mouth about Wall Street (just curious: were you one of those protesters recently arrested?). History has furnished no example of a drug company–or any company–in a free market, profiting from its poor service to its customers. Only state-owned companies or state-sanctioned monopolies have engaged in the activities you have suggested. The biggest drug disaster in history was the Thalidomide disaster. The firm which manufactured that drug didn’t make a profit from the disaster, did it? Did BP make a profit out of the oil spill? In a competitive market, you will still see irrational behavior among firms. And you will also see their inevitable death.

Now get educated. And get a life!

guffaw October 2, 2011 at 4:45 pm

Dear recent DeVry grad who thinks he’s educated because he posts a link to a YouTube clip:

Corporations aren’t evil necessarily, but they exist for one purpose and one purpose alone. It is interesting that you assign de facto noble intentions to corporations. In any event it’s childish to anthropomorphize inanimate objects, or in this case entities.

BP hasn’t made a profit from the oil spill – nice straw man – but it’s still in business, still churning out record profits. It escaped with the equivalent of a financial slap on the wrists for damage the extent of which the company has not only actively tried to downplay but outright obfuscate. I don’t expect you to believe that, even though it’s well-documented. Facts don’t matter to retarded idealogues.

Again, where were the fines/perp walks for the massive amount of financial corruption we just lived through? I hear the sound of crickets from you, a-hole.

DIAF.

libertarian_adi October 3, 2011 at 2:58 pm

Aw, Mr. Public school dropout who jerks off to Michael Moore wants to talk more. Well, I would rather waste my time urinating on Obama’s picture or reading Paul Krugman. Get lost.

Michael Caton October 2, 2011 at 10:48 pm

It’s kind of funny to think what the world would be like if there were an FDA for the technology industry too:
http://thelateenlightenment.blogspot.com/2011/07/if-there-were-dea-and-fda-for-software.html

mulp October 3, 2011 at 4:19 am

There is.

For life critical situations, approvals generally required government regulatory approval, sometimes done in a public-private partnership.

For software in an aircraft,the software must be tested and validated to the approval of the FAA, and numerous other government regulators in Europe and Asia – just like medical products, but the FAA in involved in every accident investigation to determine that cause and correction, something not true for products under the FDA.

For software in nuclear power plants, the testing and validation is overseen by the NRC.

For software for high security computer and communication systems, testing and validation must be performed and approved by some quasi-secret agency related to the NSA and DOD.

For software for military systems, testing and validation must be performed and approved by DOD agencies. Consumer GPS’s did not under go such testing and validation, and thus was not suitable for Iraq and Afghanistan, but for a number of reasons, they were used and then authorized in Afghanistan and Iraq which required enabling the unsecured signals giving the enemy the same positioning data. And some GPS products were rushed into the field without validation leading to friendly fire incidents. Of course, this is nothing new – maps must be validated and approved for war zones to ensure consistent datum between all maps whether on paper or in software.

Products used in construction must be tested and validated, with agencies like UL being part of the insurance industry but with the government enforcing product conform by the building codes and the building inspectors, and the building codes and inspections rated by private insurers. In Europe and Asia, the UL equivalent is a government agency like the FDA.

Old Oncologist October 3, 2011 at 1:00 am

What the definition of “safe”? How about cisplatin which causes severe nausea, vomiting, and asthenia in most people, not to mention renal failure, hearing damage, and neuropathy?*
Homeopathic nostrums which contain 99.999% water are safe.
How about vemurafenib which causes skin cancer in 24% of patients?**

*cures testicular cancer
**exciting treatment for melanoma

Safe can only mean having a favorable risk/benefit ratio. Everything else is empty sloganeering. Why not just say that we should do away with the FDA in an open way. The pharmaceutical industry is full of good people and would probably not market a shoddy product more than 5-10 per cent of the time.o

guffaw October 3, 2011 at 1:41 am

The financial services industry is full of good people and would probably not market a shoddy product more than 5-10 per cent of the time.o

Probably. And that 5-10% number drawn from thin air. At least nothing major is at stake.

czrpb October 3, 2011 at 12:21 pm

I dislike Andy’s idea: Who is doing all the “access[ing]“, “respon[ding]“, “compar[ing]“, “analys[ing]“?

“Once safety is proven, patients could access the medicine in question through qualified physicians. Patients’ responses to a drug would be stored in a database, along with their medical histories. … The response of any patient or group of patients to a drug or treatment would be tracked and compared to those of others in the database who were treated in a different manner or not at all. These comparisons would provide insights into the factors that determine real-life efficacy: how individuals or subgroups respond to the drug. The technology would facilitate such comparisons at incredible speeds and could quickly highlight negative results. As the patient population in the database grows and time passes, analysis of the data would also provide the information needed to conduct postmarketing studies and comparative effectiveness research.”

Sounds like us: “Another proposal would allow patients to choose between medicines whose efficacy has been determined in different manners.”

I do not want to spend my time doing this: It seems to me that this whole “Free[dom] to Choose” — in the way our society is setup — would take all my time. In short, do we really have the time to micro-manage our own lives? Really? I have time to manage my mechanic? I have time to manage my kids’ teachers? I have time to manage my kids’ coaches? I have time to manage my grocer? I have time to manager my recycler? What am I missing?

libertarian_adi October 3, 2011 at 3:00 pm

And did you have time to manage your government?

czrpb October 3, 2011 at 4:49 pm

Nope.

gamesliga October 7, 2011 at 3:27 pm

gamesliga bahis sitesi.
gamesliga yüksek oranlı iddaa oyna.
gamesliga gamesliga referans kodu servisi.
gamesliga gamesligaya üyelik üye olma
gamesliga referansı bahis sitesi.
gamesliga referans yüksek oranlı iddaa oyna.
gamesliga üyelik gamesliga referans kodu servisi.
gamesliga referans gamesligaya üyelik üye olma

Comments on this entry are closed.

Previous post:

Next post: