For Med Free Speech

The Post reports:

The Obama administration intensified its public campaign against health-care fraud Wednesday … as prosecutors unveiled a record $2.3 billion settlement with Pfizer.

Except this “fraud” is suggesting to doctors that they do things that it is completely legal for them to do:

Pfizer Inc. agreed to a $1.2 billion criminal fine, the largest in U.S. history, and a felony plea by a subsidiary to close an investigation into what government lawyers described as fraudulent marketing of drugs.  … “When a drug is marketed or promoted for non- authorized, so-called off-label uses, any use not approved by the FDA — as was the case here — public health may be at risk,” Associate Attorney General Tom Perrelli said at a news conference in Washington. … Doctors can prescribe medicines for off-label conditions — uses not approved by U.S. regulators. Drugmakers aren’t allowed to promote medicines for those purposes.  Proceeds from the settlement will go to U.S. government health agencies. … The False Claims Act, dating to the Civil War, lets people file fraud claims on behalf of the government. Six whistleblowers will share $102 million of the settlement.

Alcohol companies would similarly be prosecuted for marketing “fraud” if they paid for ads truthfully telling people that most studies find that moderate alcohol drinkers are healthier than those who consume no alcohol.  Of course it is legal for such firms to pay academics and pundits to say such things – such firms just aren’t allowed to say such things directly.

U.S. citizens do not have free speech regarding health and medicine.  Academics and pundits mostly have free speech about such things, and individuals may speak freely if they don’t pay to do so.  But otherwise we have decided that health and medicine are too important to allow free speech – with free speech people might be persuaded to disagree with the authorities.

In contrast, I am persuaded that the usual arguments for freedom of speech apply well to health and medicine.  And I certainly don’t think we should use the word “fraud” to describe people saying true things that it is illegal for them to say.

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  • curious

    i’d love to see the day when drug companies start saying “true things”.

  • Curt Adams

    The problem is according corporations the rights of people (like free speech), which is nonsensical. Corporations are an artificial structure, deliberately created by government and overriding certain principles of a fair society (most notably liability). Theoretically they exist for the benefit of society, although in practice their enormous lobbying capacity means they exists in large part just to benefit themselves.

    Once you recognize corporations are an artificial government-created construct created for the benefit of society, you also will acknowledge that regulating their speech for the benefit of society is perfectly reasonable. It in no way restricts free speech rights of the various individuals associated with the corporation.

    Now if you want to argue over whether prohibiting drug companies from making *possibly* true statements that have not met the muster for an particular objective standard of truth, that’s a legitimate discussion. But that discussion should be over whether the ban is beneficial, not whether any ban is legitimate.

  • TGGP

    Curt, how can you restrict the speech of the corporation without restricting that of the individuals associated with it?

    I think the purchasers of the drugs can have standing to sue the companies for fraud if they misrepresent their product, but it doesn’t make sense for the government to go after them if people are still happy to buy the product.

    • Dan

      It is definitely within the rights of the government to restrict and regulate the commercial activities of individuals. I don’t know about you but it is trivial for me to separate my commercial activities from my individual/leisure/personal/political ones.

      A good rule-of-thumb is that i don’t get paid for the latter by my employer… if I get paid I am actually required by contract to advance my companies commercial interests.…

  • Matt

    Following Curt’s logic we should restrict what married people say, especially when it comes to relationships, because marriage is a construct created by government.

    I do have a question about the idea that corporations don’t have freedom of speech. I thought this concept applied strictly towards it’s advertisments. Where did this concept come from? What is the constitutional basis for it? Was there a court ruling that established it?

    • mravery

      More accurately, the government could regulate what the “marriage” says, not what the individuals involved in the marriage say. At this point, most marriages don’t have spokespeople, so this is not a problem.

  • jonathan

    Wow, actual nonsense from you today. They were marketing drugs approved for one use to be used for another use. The laws governing the safety of drugs has nothing to do with free speech at all. If your point is somehow “libertarian” that there should be no government, that there should be no drug approval process, that there should be no governmentally addressed safety concerns for medications, then the only response is thank God you aren’t in charge. Heck, even the most GOP run states don’t agree with you; Utah just passed a law equating texting with drunk driving in accidents. Everyone accepts the role of government in maintaining the safety of the citizenry – it’s even in the freaking preamble to the Constitution.

    This is not a free speech matter. Period. To redefine it as free speech, you have to remove the very reason why government exists as we’ve defined it in our Constitution and in every law on every set of books in every jurisdiction.

    • Joe

      If your point is somehow “libertarian” that there should be no government, that there should be no drug approval process, that there should be no governmentally addressed safety concerns for medications, then the only response is thank God you aren’t in charge.

      There should be no government. Drug approval should not be done by the government, a free market solution is both possible and would work out better for consumers and drug entrepreneurs. As far as safety concerns go, allow me to give a simple example of how the free market could potentially solve this problem, they could be ‘certified’ or whatever by various private organizations like: ‘UPENN Certified’, ‘Mayo Clinic Approved’, ‘Duke Accredited’ etc.

      Then when a certain drug fails, i.e. causes negative consequences, the person/organization that certified it will take the loss as well. It creates more incentive to do right by consumers and to protect one’s own brand (all in the name of *Gasp* Self-interest). If a drug fails currently, the government stays in business – there is no automatic weeding out process in bureaucratic systems like there is in the market economy.

      I’m not saying this is the process that would evolve out of the market, but this is a hypothetical example of how the market could seek to meet this consumer demand.

      Anything the government does, the private market can do better.

      • Anything the government does, the private market can do better

        I know you are trolling, but in case you don’t, let me salute you, brave interdimensional traveler.

        Let me also give you some advice: remember that the laws of physics are different in this reality. You must resist the temptation to assume everything works the same here and your distant home.

        I’d begin my journey here on earth by visiting countries as diverse as guatemala, honduras, finland, ruanda, usa, france, rusia, etc etc. You’ll be shocked to see such diverse histories, cultures, ideologies, and outcomes, as to render your simplistic statement completely idiotic.

      • Joe

        Juan Pablo,

        I like how you give no explanation, no examples… nothing. Maybe I should employ this method next debate I have. Instead of stating counter-arguments, or attacking one’s logic, I’ll instead just spin some silly insult about space and whatnot, and list half a dozen countries with several of them misspelled (Rwanda*, Russia*).

  • Curt Adams

    Curt, how can you restrict the speech of the corporation without restricting that of the individuals associated with it?

    People can say what they will but the corporation can’t pay for it.

    The marriage business is a strawman. If a marriage granted privileges above and beyond those enjoyed by any citizen of the society, then the would be analogous grounds for restrictions on claims by the pair (but not as individuals). With only two individuals, any such restriction would be effectively meaningless anyway.

    • James K

      But the corporation is owned by actual people. When you restrict the rights of the corporation to pay for speech, you restrict the rights of those people to pay for that speech.

      Basically every right extended to corporations is a reflection of the rights of its owners. The one exception is limited liability, and even that could be largely contracted around.

      • Curt Adams

        They can pay for it on their own *without taking advantage of the substantial special advantages granted to corporations*.

      • James K

        Curt Adams: What special advantages? Like I said before, the only special advantage is limited liability and it doesn’t add up to much in this context.

  • It’s no longer free speech when someone who pays you controls your speech. Government has no interest in allowing companies to control speech like that, and plenty of interest to limit this.

    • Dan

      I agree. The corporate “free speechers” thinks they have some bullet-proof argument, until you think a bit about it. After all the corporations “speech” must be projected through a person or individual and if we limit or regulate that big evil government is trampling all over the poor little individual…

      Except, free speech is not flapping your lips non-autonomously, it is the transmission of ideas you actually believe in to others that chooses to receive it…

      So yeah tell me a corporation that is going to pay me to say what I really believe with no pre-condition or coercion, No I will say exactly what they tell me or I will get fired (payment will be withheld,which is definitely not “free speech” it is a commercial action). There is no autonomous individual just an appendage/agent performing actions of the body (actually corporation comes from the latin meaning Body)

      This little silly edifice collapses even more as we know that speech is not even prohibited for individuals, but commercial actions for remuneration.…

      A Corporation is not capable of “speech” only commercial actions that is definitely subject to restriction and regulations.

      • “it is the transmission of ideas you actually believe in to others that chooses to receive it”

        So now you believe in thought crimes – people have to “actually believe” what they say or the gov’t can restrict it. Also, you might be a ****** ****** who will lie for money (are you a lawyer by chance?) but that doesn’t mean everyone is.

      • Dan

        So now you believe in thought crimes – people have to “actually believe” what they say or the gov’t can restrict it.

        That sentence is illogical, if a person says something they don’t believe in there is no independent thought involved, thus impossible to engage in any “thought crime” . Maybe you were meaning a flapping-of-the-lips crime ?


      • TGGP

        Free-speech is the transmitting of any ideas, my blog comments are not subject to Authenticity Police.

        Newspapers, television stations and schools all pay people to transmit information, often with those paying the piper calling the tune. The first amendment covers freedom of the press as well.

  • Matt

    Just because a drug isn’t approved for a certain use doesn’t mean it isn’t suitable for that use. Imagine a situation where the approved drugs to treat a certain condition are ineffective. Isn’t it best to know of any potentially effective medications, even if those alternatives are not approved for a condition? Shouldn’t doctors and patients be able to determine if any potential risks are worth taking?

    Limiting speech limits choice.

  • Some abstract right of free speech is not really the issue. The issue is why drug companies are prohibited from pointing people to non-FDA data about off label uses of drugs that have already been proven safe.

    Richard Epsteiin summarizes the issue in the Wall Street Journal () and provides more detail in a talk given to University of Chicago Alumni ().

    The legal background is that for the FDA to approve a drug, it must be proven safe and effective. But the FDA only regulates the sale of drugs not the practice of medicine, so doctors can prescribe a drug for whatever purpose they want, even one for which the drug was not approved by the FDA. Because we are only talking about drugs that have been approved by the FDA, we know they are safe (i.e. have passed Phase I trials).

    Epstein makes a compelling argument that If we let the FDA regulate only the safety of drugs and not the effectiveness we would be much better off. Here is why: It is very difficult to get studies results that prove effectiveness of off-label uses of drugs for cancer. Therefore many potentially helpful uses of safe drugs are not FDA approved and people suffer as a result. Non-drug company databases describing experiences with off-label uses exist, but they are relatively hard to find and use. Further, the universe of drugs that can be prescribed for off-label uses is artificially constrained by the fact that for any drug to be prescribed for an off-label use, that drug must first have been proven safe and effective for some other use (i.e. the on-label use). If drugs are proven safe to the FDA in Phase I trials, why not allow more experimentation and dissemination of information about other uses?

    It is against this backdrop that the accusations of “fraud” against Pfizer for disseminating true information about off-label uses seems so unfair and misleading.

  • Curt Adams

    There’s plenty of free speech for unapproved drug use. Doctors talk about them, researchers talk about them, and patients talk about them. Good uses get out there. The drug companies’ problem is that that kind of speech and analysis, by unbiased and relatively informed participants, doesn’t particularly favor very expensive drugs still under patent. So they try to broadcast to end consumers, who are frequently desperate and generally uninformed due to time constraints (it takes years of full-time education to have a good general medical background). The drug companies observe, correctly, that general consumers will know little of alternative, cheaper or safer, treatments, and count on the responsibility – scattering complexity of our health insurance system to make the doctors throw up their hands and prescribe the (uselessly) pricier alternative.

    If you want to stand on a street corner and hand out leaflets for Nexium, go right ahead. Nobody will stop you. This is not a free speech issue.

    • Drug companies are not even allowed to have a web page that links to other information on off-label uses for their products.

      It’s true that good uses “get out there” but less reliably than if the drug companies could do promotion. Likewise, news would “get out there” if newspapers were banned.

  • tim

    I don’t think corporations should be accorded free speech for the same reasons they shouldn’t be allowed to form militias or own guns. Corporations are not people and they do not have individual rights under the Constitution.

    • TGGP

      Some individuals have tried to get around gun laws by saying they have formed their own militias, and such arguments have been rejected by courts which claim the National Guard has superseded all militia. Corporations DO own guns obviously: how can a gun manufacturer (or retailer) sell guns if it doesn’t own them in the first place?

  • I note that the

    …covers a lot more than just medicine.

  • Floccina

    What would enforcement like this do to organic food sellers and supplement sellers.

  • I don’t think the issue is corporate vs. individual speech, but commercial speech (which is offered less 1st amendment protection).

    \42\Commercial speech when engaged in by a corporation is subject to the same standards of protection as when natural persons
    engage in it. Consolidated Edison Co. v. PSC, 447 U.S. 530, 533-35
    (1980). Nor does the status of a corporation as a government-regulated monopoly alter the treatment. Id. at 534 n.1; Central Hudson Gas & Electric Co. v. PSC, 447 U.S. 557, 566-68 (1980).

    “Commercial speech,” the Court has held, is protected “from
    unwarranted governmental regulation,” although its nature makes such
    communication subject to greater limitations than can be imposed on
    expression not solely related to the economic interests of the speaker
    and its audience.\3\ Overturning of this exception in free expression
    doctrine was accomplished within a brief span of time in which the
    Justices haltingly but then decisively moved to a new position.
    Reasserting the doctrine at first in a narrow five-to-four decision, the
    Court sustained the application of a city’s ban on employment
    discrimination to bar sex-designated employment advertising in a
    newspaper.\4\ Granting that speech does not lose its constitutional
    protection simply because it appears in a commercial context, Justice
    Powell, for the Court, found the placing of want-ads in newspapers to be “classic examples of commercial speech,” devoid of expressions of opinions with respect to issues of social policy; the ad “did no more than propose a commercial transaction.” But the Justice also noted that employment discrimination, which was facilitated by the advertisements, was itself illegal.\5\

    \3\Central Hudson Gas & Electric Corp. v. Public Service Comm’n,
    447 U.S. 557, 561 (1980).

  • kebko

    As far as I can tell, most of what we might call “marketing” from the drug companies is what other fields might call “kickbacks” or “bribes”. The tracking technology is incredible. Drug salespeople know exactly who is prescribing what & the highest prescribers are well-oiled. “You have prescribed so much ‘Product X’, that you would probably have a lot to say about it at our upcoming seminar at St. Croix. We have you scheduled to speak from 9:00am to 9:15, right before the crableg brunch.” I assumed that this was universally known, but maybe it isn’t.
    I realize that this is a product of government regulations creating 3rd party agent issues, but the big drug companies are doing a nasty business, nonetheless.
    As I understand it, one strategy that can be lucrative is to get a drug approved for some minor issue so that it is available for doctors to prescribe under these rules. If you’re pushing some malleable doctors to be your best performers, you can get a lot of volume if they prescribe off-label.

  • John Maxwell IV

    What exactly are the “usual arguments for free speech”? The main reason we place so much importance on free speech as a culture is because it’s difficult to have a totalitarian government that upholds free speech, and totalitarian governments are really bad. Totalitarianism is hard to define precisely, but by holding free speech as sacred we create a bright line that government officials feel a strong obligation not to cross.

    However, this scheme works just as well if we replace “freedom of speech” with “freedom of speech regarding politics”. The government *should* be allowed to censor books that cause 10% of previously happy folks to commit suicide after reading them (assuming no counterbalancing positive effects.)

  • Dan

    You mean freedom to lie… oh wait I am actually allowed to do that… I can claim that alcohol cures cancer… Actually I will do it right here. Alcohol will take away your cancer!

    It is fraud, if I am payed to say it by an alcoholic company though (unless they maybe doesn’t accept any money for their product)… and funnily enough I won’t be prosecuted for it, the company will face sanctions and I will face some loss of income…

    So yes paying someone to lie, or make unproven claims is not allowed…

    Regarding “off-label” use, there is a reason it is off-label, the claims has not been proven through clinical trials.

    • Matt

      “off-label” ONLY means that the drug is not approved for a given use. It does not mean that claims are unproven.

      If the use of a drug to treat a certain condition is not proven through clinical trials… the answer sometimes should be, “so what”? Take a look at modafinil, for example. It is known to be an effective treatment for many of the same conditions for which amphetamine/methylphenidate are approved, but modafinil does so with less side effects. Modafinil is also believed to have less of a potential for abuse. But modafinil is not approved for some of the conditions it can treat. (on the other hand, this means that more people get prescriptions for methylphenidate and amphetamine – which are available as cheap generic drugs.)

    • John Thacker

      Regarding “off-label” use, there is a reason it is off-label, the claims has not been proven through clinical trials.

      Untrue. Look up the clinical studies on prazosin and treating nightmares from Post Traumatic Stress Disorder. It’s been proven by independent research to anyone’s scientific standard; it’s just not approved for that use because of how expensive and time-consuming it is to get through the FDA process.

      So the Dept. of Veterans Affairs sort-of officially recommends the off-label use, except that they can’t entirely do that legally.

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  • Matt

    You left out some of the story, as below. Your faith in the benevolence of drug corporations is touching. Read your history. Laws of this sort were passed for a reason–pharmeceutical fraud was rife before they existed–and exit in more stringent form in other developed countries.

    The Pfizer unit Pharmacia & Upjohn pleaded guilty to a single felony charge that accused the company of marketing its anti-inflammatory drug Bextra for broader uses and higher dosages than those approved by the Food and Drug Administration.

    The company allegedly enticed doctors to prescribe the drug for pain relief by taking them on lavish trips, created sham requests for medical information as an excuse to send unsolicited advertising materials to physicians, and drafted articles promoting the pills without disclosing its role in preparing the stories.

    • John Thacker

      Yes, some drug companies lie. Fraud is illegal. But the law also makes true statements illegal.

      An analogy:

      “Some corporations and newspapers and people commit slander and libel. Therefore, to prevent this, only op-eds and books judged as true by government censors can be published. Don’t worry, we’ll have an independent body of experts judge them.”

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