Archive for the 'Legal Issues' Category

May 19 2015

Federal Anti-SLAPP Statute Proposed

Americans cherish our free speech, enshrined in the very first amendment to the Constitution. SLAPP suits (strategic lawsuit against public participation) are a serious threat to that freedom of speech. We desperately need libel reform in the form of effective anti-SLAPP laws.

What I learned when I became the target of a SLAPP suit (that is still ongoing) is that anyone with money can take away your free speech at will. It works like this: if you express an opinion publicly that someone else doesn’t like because it is critical of them, their beliefs, their business, etc. then they can hire a lawyer and send you a cease and desist letter. You are now faced with a dilemma – take down your blog, article, podcast, video, or whatever and allow your free speech to be suppressed, or potentially face tens and perhaps hundreds of thousands of dollars in legal fees.

Except for those few states with effective anti-SLAPP laws (California, Washington, Oregon, Nevada, Texas and the District of Columbia – Florida just passed one which has not yet gone into effect), if you refuse to remove your free speech and you get sued, then expect to spend large sums of money and years of your life defending your rights. Here’s the thing – even if the case against you has zero merit and no chance of winning in the end, the lawsuit is a financial game of chicken. There is no way to shut the case down early. There is no bar for meritless cases.

The net effect of this is that if someone has money they can shut down your free speech at will. This, of course, has a chilling effect on free speech that can go way beyond the one instance of speech being targeted.

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Apr 27 2015

Defending Children – See, That Wasn’t So Hard

Last year two similar cases in Canada came to public attention – both involved young girls with terminal blood cancer, but ones that are very treatable. Their cancers would almost certainly result in death if they go untreated, and yet they would have about an 85% chance of survival with standard treatment. Both girls were also members of the First Nations, natives with a history of not being treated well by the Canadian government.

In both cases the family wanted to seek “traditional” treatment instead of completing chemotherapy. However, the “traditional” treatment they were seeking was holistic garbage peddled by a charlatan (who is white, and not a native) in Florida, Brian Clement. Clement is not a doctor, but claims to treat cancer with the usual assortment of popular quackery today. Recently the state of Florida accused him of practicing medicine without a license, but they then dropped the case for unknown reasons. I guess Florida just doesn’t have the political will to protect the public from harmful nonsense.

Clement’s false hope has already claimed the life of one of the girls, 11 year-old Makayla Sault died of her leukemia in January. Her mother was literally lured away from continuing chemotherapy by the promises of Clement.

What is most interesting is that the Canadian courts had an opportunity to intervene and to protect these children. They failed with regard to Sault and it is now too late for her. The second girl, whose name is not public, also was allowed to forgo chemotherapy to pursue traditional Floridian quackery. In November 2014 Ontario court Judge Gethin Edward ruled that the family has the right to deny their daughter standard medical treatment. This was done to respect the rights of the First Nations. I argued at the time, while I understand this is a sensitive issue, the rights of a young girl to live trumps everything else in such cases, and I felt this was a profound failure on the part of Judge Edward.

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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.

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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.

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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?

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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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