On the Edges of Science and Law

Blood Glucose Monitors: A Sleek 21st Century Look With Nixon Era Accuracy

 GUEST BLOGGER Ed Kraus

It is essential that people with diabetes have accurate tools with which they can effectively manage their disease on a day-to-day basis.  And, despite all the recent technological and scientific advances in diabetes management, it appears that home blood glucose monitors—one of the most commonly used and critical tools for the management of glucose levels—are not keeping pace with the times.  

In a July 2009 New York Times article, Gardiner Harris wrote that the Food and Drug Administration (FDA) is considering tightening its accuracy standards for home blood glucose monitors (BGMs).  The article highlights the fact that the FDA has long followed international standards set by the International Organization for Standardization (ISO) which allow for BGMs to be manufactured with an error rate of up to 20%.  While an error rate of 20% may have seemed acceptable or reasonable 10 years ago, given our present-day technology and our current understanding of the clear health benefits of tight control of glucose levels, it is simply indefensible.

To understand why this error rate is unacceptable, it is helpful to consider what a 20% error rate for a BGM actually means for an individual with diabetes.  Let's take the example of an individual who checks her glucose level and gets a reading of 156 when, in fact, her blood glucose is only 130.  With a reading of 156, she might administer a correction dose of insulin to lower her glucose to a level within her target range.  However, had the BGM accurately displayed her glucose level as 130, she would not have taken any insulin.  This unnecessary dose of insulin could then cause her glucose levels to go too low -- meaning below the low end of her target range -- and cause her to suffer from hypoglycemia.  Alternatively, if her blood glucose level was actually 160 but the BGM gave a reading of 128, she might not administer any insulin -- because she might falsely believe that her glucose level is within her target range.  Failing to administer insulin when it is needed could lead her to becoming hyperglycemic which, over time, can cause serious health complications. 

As it turns out, in response to concerns from the American Association of Clinical Endocrinologists regarding BGMs' accuracy, in June 2009, the FDA pressed the ISO to tighten its standards.  In addition, the FDA has indicated that if the ISO does not act, the FDA will take the initiative itself by requiring higher performance standards for BGMs sold in the United States.  However, as of September 2009, the FDA has yet to do so; rather, it appears that the FDA is still merely commenting on its plans to make changes in some way or another.

It is interesting to consider why there have not been any major improvements in the accuracy of BGMs in the past decade.  BGM manufacturers have improved the technology, aesthetics, and convenience of BGMs since their introduction in the 1970s, but manufacturers have not improved the accuracy of glucose level readings -- arguably the single most important feature of a BGM.  As FDA Commissioner Margaret Hamburg has indicated, this is the result of manufacturers' contentment with meeting the international standard set by the ISO.  But this response begs the question: Why have market forces led BGM manufacturers to improve certain aspects of their products, but not accuracy? After all, most people with diabetes purchase and use BGMs with the goal of closely managing and monitoring their glucose levels, which in turn enables them to minimize the risks of long-term, diabetes-related complications.  Perhaps BGM manufacturers have taken advantage of the fact that individuals easily notice the aesthetic difference between certain BGMs, but that most BGM users likely were never (or still aren't) aware of the 20% error rate allowed by the FDA?

Whatever the reason for the market's failure to promote the development of more accurate BGMs, the solution is clear.  Whether by pressuring the ISO or creating its own higher standards for domestic BGM approval, the FDA should act quickly and decisively to put an end to the current tolerance of a 20% error rate for BGMs. 

Ed Kraus is an Associate Clinical Professor at Chicago-Kent College of Law.  Professor Kraus focuses part of his practice on representing and advocating for individuals with diabetes in education, employment and insurance matters.

I.B.M. Seeking to Make Sequencing of Personal Genome Available for the Low Low Price of $1,000 (Plus Millions in Royalties to Patent Holders)

By Jake Meyer

I.B.M. recently announced its plans to join the race to sequence the genome for $1,000.  I.B.M. joins seventeen other companies in the race to sequence the gene.  Currently the cost to sequence the human genome ranges between $5,000 and $50,000, but these companies are yet to successfully sequence the entire genome of an individual.  I.B.M. hopes to ultimately bring the price as low as $100 to sequence an individual's entire genome.  The goal is to build a machine that can sequence an individual's genome – three billion base pairs – in several hours.  This will provide the genetic information needed by an individual for personalized diagnostic and treatment uses. 

I.B.M. is using its expertise in semiconductor manufacturing, computing, and material science to design a gene sequencer with increased speed and accuracy.  I.B.M.'s sequencer revolves around a nanoscale electric device.  The device uses an electric field to pull the DNA strand through a 3 nanometer hole in a surface, at which point the electric field holds the DNA in place for a fraction of a second while the order of the nucleotide bases (adenine, guanine, cytosine, or thymine) is determined.  After the nucleotide bases are determined, the DNA strand is pulled further through the hole and the order of the next nucleotide bases are determined.

Motherhood Divided: What Should Happen When a Clinic Gives a Woman the Wrong Embryo?

By Lori Andrews

When Carolyn Savage learned she was pregnant through in vitro fertilization, she and her husband Sean rejoiced.  A few weeks later, though, they received devastating news.  The clinic had implanted the wrong embryo in her.  Rather than carrying their own genetic child, Carolyn was carrying the embryo of another couple.

While some women might have chosen to terminate a pregnancy, the Savages' own moral beliefs precluded that option.  So instead, they selflessly went forward with the pregnancy, agreeing to turn the baby over after birth to the child’s genetic parents.  The one thing Carolyn Savage requested was a moment for her and Sean to be alone with the baby.  She said, "We want a moment to say hello and goodbye."

In an interview on the Today Show, Carolyn's absolute emotional pain comes through.  Whatever abstract legal ideas currently exist about the weight given to genetic bonds over gestational bonds, Carolyn had already begun a nine-month relationship with this child.  And, to make matters worse, she will not be able to carry another child.  If she and her husband want to procreate further, they will have to hire a surrogate mother to carry their remaining embryos.

Prometheus Labs, Inc. v. Mayo – Administering a Drug is Transformative

 By Jake Meyer

Recently the Federal Circuit ruled on the case Prometheus Labs, Inc. v. Mayo, a case involving 35 U.S.C. §101 subject matter.  Prometheus came before the Federal Circuit as an appeal from a decision from the United States District Court for the Southern District of California to grant summary judgment of invalidity of Prometheus’s patents (U.S. Patents 6,355,623 and 6,680,302) finding that the claims were directed to non-statutory subject matter.   The case was a little unusual in that it was decided by two Federal Circuit judges, Michel and Lourie, and District Court Judge -- Judge Clark of the United States District Court for the Eastern District of Texas.  The patents claim methods for calibrating the proper dosage of thiopurine drugs, which are used for treating autoimmune diseases.  Since the patents are directed to a process and the case involves a subject matter inquiry, the Federal Circuit was able to revisit In re Bilski (a case now before the Supreme Court) and apply the test for subject matter eligibility of a process the Federal Circuit laid out in Bilski.

Thiopurine drugs are used to treat inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis.  Thiopurine drugs include 6-mercaptopurine (6-MP), and azathiopurine, which upon administration to the patient converts to 6-MP.  The body breaks down 6-MP into different metabolites, such as 6-methyl-mercaptopurine (6-MMP) and 6-thioguanine (6-TG).  Prometheus’s patents involve the measurement of these metabolites.  For example, claim 1 of patent 6,355,623 is representative of the claims in the Prometheus:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Patent Infringement Case May Be Damaging to Microsoft and My Preferred Word Processor

By Jake Meyer

Microsoft is currently involved in a patent infringement case involving its word processor program Microsoft Word.  The outcome of this case could determine the fate of Microsoft's most well-known software.  In fact, this very blog post was composed on Microsoft Word.

Microsoft's Word program allegedly infringes Canadian software developer i4i's U.S. Patent No. 5,787,449.  The asserted claim (claim 14) of this patent is directed to "markup languages" for computers.  A markup language inserts "tags" that indicate how a text should be displayed between the tags.  XML, HTML, and SGML are all examples of markup languages.  Microsoft’s brief to the Federal Circuit gives an example of markup language. "For example, <Para> is a computer markup code that indicates the start of a paragraph and </Para> indicates the end of a paragraph."  Claim 14 claims this markup language as a method for producing a "map of metacodes":

A method for producing a first map of metacodes and their addresses of use in association with mapped content and stored in distinct map storage means, the method comprising: providing the mapped content to mapped content storage means; providing a menu of metacodes; compiling a map of the metacodes in the distinct storage means, by locating, detecting and addressing the metacodes; and providing the document as the content of the document and the metacode map of the document.

"What if our perception of normal exposure is skewed?": Analyzing the Science of BPA

by Sarah Blenner

Bisphenol A (BPA) is an estrogen mimicking chemical commonly used to create both polycarbonate plastics and the resin lining of cans.  This chemical can be found in plastic food and beverage containers, cans, dental sealants, household products, cell phones, computers, and medical devices.  Hundreds of studies link the synthetic hormone, BPA, to a variety of adverse health conditions, including, breast cancer, prostate cancer, ADHD, autism, obesity, insulin resistance, type 2 diabetes, liver enzyme abnormalities, early onset of puberty, and cardiovascular disease.

In a study conducted by the CDC, scientists found that BPA was present in 93% of Americans tested, signifying the high prevalence of BPA exposure in the American population.  One participant of the "Is It In Us?" study, which measured the presence of toxic chemicals, such as BPA, in the blood and urine of participants, was relieved to know that her results were no different than the results of most of the other participants.  But then she thought: "what if our perception of normal exposure […] is skewed?" 

Last May, Chicago became the third jurisdiction in the United States to successfully pass legislation regarding Bisphenol A when it banned the sale of baby bottles and other empty food and liquid receptacles intended for the use by children under the age of three.  Prior to Chicago City Council's passage of the BPA Free Kids Ordinance, the State of Minnesota and Suffolk County New York passed legislation regulating BPA.  In June, Connecticut became the fourth jurisdiction in the United States to address the health risks of BPA through legislation, when it passed an "Act Concerning Banning Bisphenol-A in Children's Products and Food Products."  According to the Public Act, beginning October 1, 2011, the sale of infant formula, baby food, and reusable food or beverage containers that contain the chemical Bisphenol A will be banned. 

Will Patent Court Police the Boundaries of the Statute?: Federal Circuit to Look at Written Description Requirement

 By Jake Meyer

A panel of Federal Circuit judges previously heard the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 2007 WL 2712087 (Fed. Cir. 2009) and held that Ariad failed to provide adequate written description for its claims to methods of the regulation of the expression of certain genes.  The Federal Circuit has granted a request to hear the case Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., en banc and in doing so will interpret a section of the Patent Act.  The questions before the Federal Circuit en banc are now:

1. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from enablement?
2. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?

DNA Evidence – A Boon to Law Enforcement, but the Start of a Storage Nightmare

by Lori Andrews

When I spoke a national meeting of law enforcement personnel and prosecutors, I was fascinated by the new forensic tools spanning every type of evidence -- from photographs to footprints, from gum to guns.  But, in the hallways, between the scientific and legal presentations, the men and women working in the criminal justice system sounded a lot like 20somethings complaining about their first apartment.  Sure, there were changes in technologies.  But there was a bigger problem:  Where were they going to store all the evidence?
 
With the advent of DNA technologies, forensic officials who had been pack rats were able to convict people of old crimes. This past weekend, for example, a suspect was arrested for the 1989 murder of an elderly woman; modern DNA technology allowed old evidence to be analyzed.   Evidence from decades ago has also been retested through efforts like the Innocence Project, letting many innocent men go free. In fact, yesterday, the Richmond Times Dispatch announced six training sessions for volunteer lawyers on how to contact the 881 Virginia felons whose old cases included evidence ripe for potentially-exculpatory genetic testing.

Jurassic Yeast

 By Jake Meyer  

In 1990, Michael Crichton wrote Jurassic Park, a best-selling novel about cloned dinosaurs created from the DNA obtained from mosquitoes trapped in amber.  Crichton’s Jurassic Park cautions us against tinkering with biotechnology by bringing the past to the present.  However, Crichton might not have considered what one microbiologist has released that was trapped in amber -- a mighty fine brew.

Raul Cano discovered that microorganisms trapped in amber, which have laid dormant in a state of hibernation for millions of years, could be revived.  In 1995, Cano extracted one such microorganism from a 45 million-year-old fossil -- a variant of Sacchramoyces cervisiae -- also known as "brewer's yeast."  But you don’t wake up prehistoric brewer’s yeast without wondering what kind of beer it would make. 

Robin Cook and Bioethics

 By Lori Andrews 

Robin Cook attended medical school before the birth of the patients' rights and bioethics movements.  Last month in New York at Thrillerfest, the national meeting of thriller writers, Cook explained that he began writing medical mysteries as a way to make the public aware of the dangers and risks inherent in modern medicine.

"Patients used to come to me and say, 'I want to be put to sleep during the operation.'  They had no idea what was going on.  I'd say to them, 'It's not like being put to sleep.  It's like being poisoned and then revived.'"