Archive for the 'Legal Issues' Category

Apr 24 2015

The FBI, Forensic Science, and the CSI Effect

Published by under Legal Issues

The FBI recently acknowledged that over a two decade period prior to 2000 they used a flawed forensic technique in their investigations – hair analysis. As reported in the Washington Post:

Of 28 examiners with the FBI Laboratory’s microscopic hair comparison unit, 26 overstated forensic matches in ways that favored prosecutors in more than 95 percent of the 268 trials reviewed so far, according to the National Association of Criminal Defense Lawyers (NACDL) and the Innocence Project, which are assisting the government with the country’s largest post-conviction review of questioned forensic evidence.

That is shocking and disappointing, but I don’t think it’s an isolated case.

Our society has come to expect high tech investigative techniques, especially at the level of the FBI and in high-stakes criminal cases such as murder trials. This is partly due to shows like CSI which showcase such technology, and exaggerate the speed and precision with which forensic scientists can tease information out of trace evidence. This effect may even be affecting juries, who expect any murder trial to be accompanied by such evidence.

Continue Reading »

Share

18 responses so far

Apr 14 2015

FDA and Homeopathy

The skeptical community is abuzz with the announcement by the FDA’s announcement that they are reviewing the “regulatory framework” of homeopathic products and are open to public input. We have written about this at Science-Based Medicine, and as you can imagine, this is a serious topic of discussion among the editors.

Background

The FDA regulates food, drugs, medical devices, supplements, and cosmetics for the purpose of protecting the public health and safety. Congress created the FDA and determines its powers. In the 1938 FDA act, one Senator, Royal Copeland, who was a physician and homeopath, included in the bill that the provision that the Homeopathic Pharmacopeia of the United States (HPUS) would be included in the list of official drugs.

What this means exactly is that homeopathic products are automatically considered drugs by the FDA. Further, any new homeopathic product added to the HPUS in a supplement also counts. All homeopaths have to do, therefore, to get a homeopathic product listed as a drug by the FDA is write it down in one of their supplements to the HPUS. That’s it. No research is necessary, no assurance of safety or efficacy.

Continue Reading »

Share

21 responses so far

Mar 12 2015

Libel Reform – In the US

Published by under Legal Issues

After Simon Singh was sued by the British Chiropractic Association for libel, he used the opportunity to rally for libel reform in the UK. Simon won his suit, but defending his free speech was tremendously expensive. Fortunately for him, he had the resources to go the distance. Libel laws in England are especially bad, favoring the plaintiff and are ridiculously expensive – so much so that they motivate “libel tourism” in which someone sues someone else specifically in England for maximal effect.

At the time I thought I was lucky for the fact that the US has more rational libel laws. The burden of proof is heavily on the plaintiff, as it should be. In the US we take our first Amendment rights to free speech seriously.

Then, of course, I was sued, and I realized how wrong I was.

The problem with libel laws in the US is that the legal battle is more about who has money than who is right. If you want to shut down someone’s right to free speech all you have to do is sue them for defamation. There is no barrier to doing so. The defendant then has the option of either taking down their blog post, article, podcast, whatever and giving in to the demands of the person threatening to sue them, or face tens of thousands or even hundreds of thousands of dollars in legal fees to defend their free speech. What do you think most people are going to choose?

Continue Reading »

Share

20 responses so far

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.

Continue Reading »

Share

35 responses so far

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.

Continue Reading »

Share

23 responses so far

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.

Continue Reading »

Share

13 responses so far

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.

Continue Reading »

Share

33 responses so far

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:

Continue Reading »

Share

165 responses so far

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.

Continue Reading »

Share

13 responses so far

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.

Continue Reading »

Share

20 responses so far

Next »