Archive for the 'Legal Issues' Category

May 10 2013

Separation of Church and State

A comment on my recent post about Backdoor Creationism calls into question the premise that the US Constitution demands separation of church and state, and therefore religious beliefs cannot be taught in public schools. The comment reads:

The first amendment states that the federal government can neither (sic) or prohibit the exercise of religion. “separation of church and state” is just a propaganda term used by some to stave off religious nuts who use undue social pressures or indoctrination to push their beliefs to others.

Here’s a section of the first amendment.

“Congress shall make no law respecting an establishment of religion or prohibiting the free exercise thereof.”

And here’s the definition of the word “respecting” from a dictionary dated 5 years after the adoption of the Bill of Rights.

RESPECT’ING, ppr. Regarding; having regard to ; relating to.

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Dec 07 2012

Promoting Off-Label Use of Drugs

The off-label use of prescription drugs is often misunderstood by conflating it with the non-evidence-based use of drugs. I actually don’t have an issue necessarily with using drugs off-label. A distinct issue is whether or not drug companies can promote off label uses, and how they can advertise their drugs at all. A recent court decision may loosen restrictions on the pharmaceutical industry (and by extension the supplement industry and the marketing of any health product).

In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech.

The ongoing battle between regulation and free speech rages on. First for some background, in the US the FDA regulates the marketing of drugs, which are defined as a substance that is used to treat or modify any disease. Supplements are now defined as substances use to enhance or improve some structure or function in the body, but cannot be claimed to treat any specific disease. So these categories are based, for regulatory purposes, on the kinds of claims that are made for them.

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Jul 03 2012

GSK Pays $3 Billion Fine

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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Jun 04 2012

Legislating Science in North Carolina

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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Apr 11 2012

Tennessee “Monkey Bill” Update

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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Mar 02 2012

I Dream of Spectral Evidence

Published by under Legal Issues

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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May 30 2011

Seismologists Charged with Manslaughter

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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Apr 14 2011

Power Balance Smacked in Another Lawsuit

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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Feb 25 2011

Supreme Court Decision on Vaccine Injury

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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Jan 04 2011

Power Balance Admits Fraud

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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