The fungal meningitis outbreak related to a compounding pharmacy’s production of methylprednisolone acetate for epidural injection has reached 354 cases and 25 deaths according to the CDC. As I reported earlier, the reasons for the outbreak are multifold, from lax regulation of the compounding pharmacy, which are pharmacies that mix approved drugs into new forms with additional, supposedly inert ingredients, to meet the needs of patients, to a procedure that is unsupported by clinical research, to pain management physicians who were trying to save a few dollars by using compounded drugs.
The New England Compounding Center (website has been replaced by a news release) is the center of attention for this outbreak, and because the FDA’s authority in regulating these types of pharmacies is limited, the state of Massachusetts has decided to step up it’s efforts in regulating, and if necessary, shutting down some of these pharmacies if they violate state and federal regulations. The New York Times has reported that Massachusetts shut down Infusion Resource in Waltham, MA, after “after a surprise inspection last week found conditions that called into question the sterility of its products, state officials said Sunday.”
Gov. Deval Patrick ordered the state’s Board of Registration in Pharmacy to immediately begin surprise inspections of compounding pharmacies that prepare injectable sterile medications. According to the New York Times article,
There are 25 such pharmacies in Massachusetts, and Mr. Patrick has acknowledged that the state rules governing them were insufficient. Although the Food and Drug Administration can inspect compounding pharmacies and issue warnings, the agency says states have ultimate jurisdiction.
At the news conference on Sunday, Dr. Lauren Smith, the interim commissioner of the Massachusetts Department of Public Health, said the state was bringing on five additional inspectors to help with unannounced visits to compounding pharmacies. The goal is to inspect all of them by Jan. 1, she added.
A number of public health advocates have called for increased FDA regulatory power over compounding pharmacies for many years, warning that these pharmacies are not currently subject to the FDA’s oversight on manufacturing, quality and efficacy. Thus, they are easily able to distribute products like the tainted steroids that pose serious public health risks without worrying about any type of significant oversight. Some members of Congress have already called for a criminal investigation into the meningitis outbreak.
Hopefully, Massachusetts will lead the way in fixing this issue, but this should be the FDA’s responsibility. Congress will probably have to revise or add new regulations for the FDA to really clamp down on this problem, or it will happen again.
- Staal JB, de Bie RA, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low back pain: an updated Cochrane review. Spine (Phila Pa 1976). 2009 Jan 1;34(1):49-59. Review. PubMed PMID: 19127161.
- Goodnough A. Massachusetts Shuts Down Another Compounder. New York Times, October 28, 2012.
Recently, the Thomas P Fordham Institute, a private think-tank focused on analyzing and critiquing the US public school system, issued a report regarding the state of each US state’s science education standards across a broad spectrum of qualitative measures from the clarity of the standards to content to rigor of the science. It is an impressive and detailed report analyzing science education state-by-state with links to science education standards and other information. It is worth reading, even just to find out how your state is doing.
Science is the foundation of engineering, biomedical research, and many other fields. Without science, Intel cannot figure out how to make faster processors. Without science, we don’t have better vaccines and cancer treatments. Without science, we have people who think that homeopathy works, or that the world is only 6000 years old, or that acupuncture works. The whole anti-vaccination lunacy requires a complete misunderstanding of science and research.
The good news
- California is one of two states (the other being DC) to get an A on the science report card. As a resident of the Golden State, I’m proud of this news, though I am somewhat concerned that the state of the economy and budget crisis is not going to help in the future. It’s also amazing what DC has done given that it is tiny jurisdiction, and that it received a C in 2005. But since I’m a California, here’s what the report says about my state:
❝The California science standards are truly excellent. The standards themselves are reasonably succinct yet quite comprehensive. This is especially true in high school chemistry, where topics are covered that are rarely seen in other K-12 standards documents. The continuity from grade to grade is superb, thanks in part to the introductory commentary, and context that the state provides, which relate grade- pecific learning to standards that have been covered in earlier grades, and those that will be covered later.❞
- Four other states, Virginia, Massachusetts, South Carolina (which surprises me), and Indiana (despite an ongoing unconstitutional attempt to push creationism on its students) received an A-.
- Seven other states received B’s. However, if we are to accept a B as an acceptable result for science education in the US, the one area of study that is critical to American economic and technical leadership, then US science education will fall further behind the booming economies in Europe and Asia.
- Given the above information, 38 states had a C or below grade. In fact, the average “grade” for science education in the US is a C. Average. Mediocre.
- Ten states had F grades, which must indicate that they occasionally use the word “science” in a spelling test. Some of these states had F’s in the 2005 report, so they’re not even trying to improve. Even Wisconsin, which has a top-rated university system, received an F for their students. Maybe the University of Wisconsin’s science programs only accept out-of-staters and international students.
- Many of the lower performing states don’t even lay out a basic curricula for science.
- The variability in standards and implementation is inconsistent across the country. Why should a California child be better trained than one from Alabama? Of course, the result of that science education is that California has a world-class university system (3 of the top 100 universities in the world are UC-Berkley, UCLA, and UC-San Diego) and is the world leader in computer technology. Alabama, of course, has good football teams.
- An undermining of evolution. Many of us have been writing about the regular demand by conservative Republican state legislatures to foist creationism on their students. In the famous words of Theodosius Dobzhansky, “nothing in biology makes sense except in the light of evolution.” Evolution is one of the four principles of biology (also including cell theory, genetics, and homeostasis), so without a deep and thorough understanding of evolution, medical research will fall apart. How are we to save lives and treat diseases if students can’t even understand the essentials of biology?
❝Of course, most anti-evolution efforts are aimed more directly at the standards themselves. And these tactics are. far more subtle than they once were. Missouri, for example, has asterisked all “controversial” evolution content in the. standards and relegated it to a voluntary curriculum that. will not be assessed. (Sadly, this marks a step back from that state’s coverage of evolution in 2005.) Tennessee includes evolution only in an elective high school course (not the basic high school biology course). And Maryland includes evolution content in its standards but explicitly excludes crucial points from its state assessment.
Other states have undermined the teaching of evolution by singling it out as somehow not quite as “scientific” as other concepts of similar breadth. A common technique—used to a greater or lesser extent by Colorado, Missouri, Montana, and West Virginia—is to direct students to study its “strengths and weaknesses.”
Far too often, important evolution content is included, but minimally. Some states mention evolution just once in their standards and never revisit it. Others—including. Indiana, Iowa, Kansas, Kentucky, Michigan, and Nebraska— unnecessarily delay it until high school.
Even some of the nation’s best standards subtly undermine. the teaching of evolution. In California, for example, students are told to “understand science, not necessarily [to] accept everything taught.” In New York, students learn that “according to many scientists, biological evolution occurs through natural selection.” (This is not according to “many” but, in fact, all true scientists.)
Finally, conspicuously missing from the vast majority of states’ standards is mention of human evolution—implying that elements of biological evolution don’t pertain to human life. This marks a subtle but important victory for creationists: even states with thorough and appropriate coverage of evolution (e.g., Massachusetts, Utah, and Washington) shy away from linking the controversial term with ourselves. Only four states—Florida, New Hampshire, Iowa, and Rhode Island—openly embrace human evolution in their current science standards. (Pennsylvania, which. referenced human evolution in its previous standards, has omitted it from the more recent version.)❞
- Propensity to be vague. Some standards are so unclear and ill-defined that teachers actually have little guidance as to what to teach their students. California, for example, lists out what students should “know” about electricity upon completion of a physics course. Within that list, a good science teacher (like the one I had when I was in high school, who developed my interest in sciences) will create a lesson plan that is both invigorating and builds knowledge. Maybe the intent of some school boards are vague guidelines to inspire independent teaching, but in a subject as critical as the sciences, strict standards are necessary–and good science teachers will use those strict standards to build exciting, challenging and inspiring curricula.
- Poor integration of scientific inquiry. Science isn’t all about memorizing muscles, organism names, or how to create the Kreb’s cycle given CO2, H2O and NH3 (my single question in a Biochemistry final exam many years ago). It’s about the scientific method, the critical and analytical process that essentially leads an individual from observations to a scientific theory. It’s how science works, it is what distinguishes it from all other forms of thinking. Apparently, most states don’t guide the teacher on how to provide this type of teaching to their students, a major deficiency.
- Where did the numbers go? If evolution is one of the foundations of biology, then mathematics is the foundation of all sciences. Students need algebra, at a minimum. But calculus and statistics needs to be integrated into the teaching, as it is critical to analyzing data and understanding how the data makes sense. Even if someone is going to forsake the sciences for business in college, algebra and calculus are also critical to accounting and finance.