The pharmaceutical giant, GlaxoSmithKline, has agreed to pay three billion dollars in fines to settle three charges of fraud brought by the FDA. This is the largest health fraud settlement in US history. What are the implications of this settlement for how the pharmaceutical industry is regulated in the US and for the role that “Big Pharma” allegedly plays in US health care?

The three fraud charges admitted to by GSK include promoting the off-label use of two anti-depressant drugs – Paxil and Wellbutrin. In the US drugs are approved for specific indications, and they can only be marketed for those indications. So-called off-label use of drugs, however, is very common. Off-label does not necessarily equate to bad medicine, or to lack of scientific evidence or rationale. Often there is solid basic science and clinical evidence to support a specific use of a drug that is not approved by the FDA. That simply means the manufacturer did not apply to the FDA for that indication, which could simply be because they did not feel they would recoup the millions of dollars they would need to spend to get approval for the additional indication. In other words, FDA approval for secondary indications is as much about marketing and finance as it is about the science.

Regardless of whether or not a specific use is evidence-based, however, the rules regulating pharmaceutical companies are very clear – they cannot market a drug for a non-approved use. Doing so breaks the law. GSK broke the law.

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The history of governments meddling in the practice of science is not a good one. The most infamous case is that of Lysenkoism -Stalin backed the ideas of Trofim Denisovich Lysenko who believed in the inheritance of acquired characteristics. His ideas became of the official sanctioned science of the Soviet government. Genetics was declared a “bourgeois science,” or “fascist science,” and many geneticists who disagreed with Lysenko were executed or sent to labor camps. Execution tends to have a chilling effect on the free exchange of ideas and the practice of science. Over seven decades later genetic science in Russia is still lagging behind.

In the US we have a similar problem – not the Gulag, but political factions that disagree with certain findings of science that are ideologically inconvenient for them. The two biggest issues being targeted (but certainly not the only ones) are evolution and climate change. Much of the focus has been on what should be taught to students in science class (my vote is for science).

Recently the North Carolina legislature proposed House Bill 819 to study the effect of climate change on sea levels, and therefore coastlines. For some reason the legislators felt the need to include in the bill specific restrictions on how the science can be done. Section 2 includes this line:

These rates shall only be determined using historical data, and these data shall be limited to the time period following the year 1900. Rates of sea-level rise may be extrapolated linearly to estimate future rates of rise but shall not include scenarios of accelerated rates of sea-level rise.

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I wrote two weeks ago about the latest state bill attacking the teaching of evolution, this one in Tennessee. This particular bill has perhaps attracted more media attention than other similar bills because Tennessee was the location of the famous Scopes Monkey trial. At the time the bill had passed the state house and senate, and we were awaiting the decision of Governor Bill Haslam on whether or not he would sign the bill.

Now our waiting is over. Haslam did not sign the bill, but neither did he veto it. He allowed the bill to pass without his signature.

I had speculated that perhaps Haslam was looking for a politically acceptable (for Tennessee) justification for vetoing the bill, as he stated publicly that the bill might represent legislative intrusion into an area reserved for the board of education. It now seems that speculation was overly optmistic, but not entirely without merit. Haslam indeed did not want to appear to be supporting the bill, but also did not want to veto a bill that is apparently popular in his state. About his decision he has officially stated:

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During the European witch hunts that came in waves throughout the 15-17th centuries “spectral evidence” was allowed in court, as it was during the Salem witch trials as well. Spectral evidence is testimony based upon the dreams or visions of a witness. They could, for example, say that a visage of the accused came to them in a dream and put a curse on them. Reverend Cotton Mather, a prominent figure in the Salem witch trials, supported the use of spectral evidence, but cautioned that it should not be relied upon as the sole source of evidence because Satan could take the form of an innocent. His father, Increase Mather, after the trials opposed the use of spectral evidence on the same basis – not that it was an arbitrary and unreliable source of evidence, but because it can be the work of demons.

Alas, the specter of spectral evidence still lingers in our modern world. A Saudi court is considering whether or not they should allow a genie (or jinn) to give testimony in open court. (Actually this story is about a year old, but it just making its way to English-speaking news outlets, but the outcome of the case has not.) The case involves accusations of corruption and bribery – a judge is accused of taking a bribe to let off a defendant in his court. In his defense the judge claims that he was possessed by a genie summoned by the defendant, who is a sorcerer (that’s right – the “devil made me do it” defense). In order to prove his case the court allowed testimony from a cleric who claims to talk to genies:

The paper said the court summoned Fayez Al-Kathami, a well-known cleric and Raqi who is believed to have the powers of speaking to jinn.

It said the court summoned Kathami after the arrested judge said he was possessed by jinn through another defendant, who is a sorcerer.

Kathami told the judge later that he managed to “question” the jinn that had possessed the judge and would present a report to the court.

The attorney who is defending the man now accused of summoning a genie to possess the judge trying his case is not pleased with this line of evidence. He has requested that the court summon the genie directly so that it can give its testimony before a live court. It seems this is a ploy to have the genie’s testimony thrown out as hearsay – if the genie cannot appear in court to give its testimony against his client, then it should not be admitted. Given the situation that lawyer is in, I guess that’s a reasonable approach.

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The Italian Government has charged their top seismologists with manslaughter because they failed to predict the devastating 2009 earthquake, which killed 308 people. The scientists, and the seismology community, are stunned – primarily because it’s impossible to predict earthquakes.

On it’s surface the story is pretty sensational and downright silly:

Judge Giuseppe Romano Gargarella said that the seven defendants had supplied “imprecise, incomplete and contradictory information,” in a press conference following a meeting held by the committee 6 days before the quake, reported the Italian daily Corriere della Sera.

That may have something to do with the fact that earthquake science is imprecise, incomplete, and often produces contradictory information. The scientists and their colleagues are calling this a witch hunt and warn that it will have a chilling effect on scientists, a very real concern.

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By now most people have heard of those Power Balance bracelets – small rubber wristbands with a cheap hologram or three embedded in them that some pro-athletes (with or without being paid to do so) claim improve their performance. The company makes a variety of claims on their website and promotional material – or I should say they used to:

• “Power Balance holograms are embedded with frequencies that react positively with your body’s natural energy field to improve balance, strength and flexibility;
• “Power Balance holograms are designed to work with your body’s natural energy field;
• Power Balance is Performance Technology;
• Power Balance products boost the body’s self defense mechanisms creating the immediate benefits of strength, balance and flexibility gain;
• When the hologram comes into contact with your body it gives you that added balance, strength, flexibility;
• Use of the Power Balance results in lots of endurance and stamina”

The company was claiming, prior to a pair of lawsuits, that a small piece of rubber and plastic being next to the body can have a physiological effect – to improve balance, strength, flexibility, endurance, and stamina. This is as close to magic as you can get – they are selling magic amulets to the gullible. (To be clear, I am not in the habit of blaming victims of this kind of fraud, but there is no way around the fact that buying the magic amulet constitutes gullibility.)

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I previously wrote about the case of Hannah Bruesewitz, a girl who developed a seizure disorder soon after receiving her third in a series of five DTwP vaccines. (You may want to read the previous post before going on, and this post is a follow up.) To briefly recap – Hannah’s parents claim that the DTwP vaccine caused their daughter’s brain injury and seizure disorder. They sued in vaccine court and their case was dismissed. So they decided to file a civil suit.

The Supreme Court has now ruled on whether or not the parents can sue in civil court for an alleged vaccine injury – and they decided 6-2 that the answer is no.

There are a couple of issues here. One (which was actually not the focus of the SC ruling) is whether or not the DTwP vaccine causes neurological injury. I reviewed the literature in my last post – essentially the evidence is against a link between this vaccine and any neurological injury. However, the DTwP has largely been replaced with the DTaP vaccine, which is potentially safer.

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In our advertising we stated that Power Balance wristbands improved your strength, balance and flexibility.

We admit that there is no credible scientific evidence that supports our claims and therefore we engaged in misleading conduct in breach of s52 of the Trade Practices Act 1974.

If you feel you have been misled by our promotions, we wish to unreservedly apologise and offer a full refund.

This is an impressive skeptical victory. One of the self-proclaimed missions of the skeptical movement (such as it is) is consumer protection. Skeptics value truth and reason, and often we will correct a misconception just for the sake of doing so. But often misinformation has a nefarious purpose – to support an ideology, or just to sell something. Deliberately using misinformation in order to create a demand for a product or service is known as fraud.

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We are in the midst of a public push for libel reform in England. (I know there is a difference between England and the UK. Apparently it is the English libel laws that are the major problem, but still the issue is often presented as reforming UK libel laws, which I guess would subsume the English laws.) This issue came most prominently to light over the British Chiropractic Association’s libel suit against Simon Singh. Simon rode that costly trial through and eventually the BCA withdrew and will have to pay Simon’s legal costs.

The episode helped fuel a libel reform campaign – a grassroots campaign to keep the political pressure on for reform. This is one of those issues that will only change with constant public pressure – and you can help. Add your signature to the petition here: http://libelreform.org/

This is an issue of free speech. While everyone deserves the right to defend their reputation from malicious attack, there needs to be a proper balance to also protect public discourse and free speech. In England the libel laws are simply broken. It is ruinously expensive to defend even a frivolous libel suit, so the threat of suit can be used to silence critics and stifle debate.

David Colquhoun on his Improbable Science blog today presents some recent examples of much needed scientific criticism being silenced by bullying libel suits.

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