Massachusetts hits compounding pharmacies linked to meningitis outbreak

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. 

Vials of methylprednisolone acetate from New England Compounding Center. Copyright, 2012, New York Newsday.

The New England Compounding Center (website has been replaced by a news release) is the center of attention for this outbreak, and because the FDA’s authority in regulating these types of pharmacies is limited, the state of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.

Key citations

What is causing the fatal meningitis outbreak?

Over the past week or so, there have been numerous reports about a fungal meningitis outbreak that was traced to medicines associated with three lots of preservative-free methylprednisolone acetate produced by the New England Compounding Center.  The drug is an injectable steroid that is used for pain relief. The potentially contaminated injections were given starting May 21, 2012. Symptoms of the fungal meningitis include: fever, new or worsening headache, neck stiffness, sensitivity to light, new weakness or numbness, increasing pain, redness or swelling of the injection site. So far, 7 people in the US have died.

Because the drug is delivered via an epidural injection directly into the epidural space, any contamination can lead to a meningitis infection. In this case the steroid produced by the New England Compounding Center was contaminated with a fungus which caused the fungal meningitis. It’s important to note that unlike other types of meningitis, such as bacterial meningitis, it is not contagious. Fungal meningitis also does not have a vaccine, because it is quite rare. (Viral meningitis is less severe, and usually resolves itself without treatment.)

Data Table for Persons with Meningitis Linked to Epidural Steroid Injections, as of October 7, 2012

Continue reading “What is causing the fatal meningitis outbreak?”

GlaxoSmithKline fined $3 billion by FDA for improper marketing and unethical behavior

Recently, the US Department of Justice ordered the pharmaceutical giant, GlaxoSmithKline (GSK), to pay $3 billion in criminal and civil liabilities in the largest healthcare fraud settlement in US history. Basically, GSK was caught promoting several drugs for unapproved uses, failing to report safety data, paying kickbacks to physicians, and price reporting. Let’s look at the fraud charges one by one.

Unapproved uses (or off-label uses). By law, pharmaceutical companies are only allowed to market drugs according to what is stated in their package labeling which is approved by the FDA. Off-label uses are the practice of prescribing pharmaceuticals for an unapproved indication or in an unapproved age group, unapproved dose or unapproved form of administration. Physicians are legally allowed to prescribe drugs off-label (as long as it is not contraindicated), but the pharmaceutical company cannot directly or indirectly influence off-label use. In most cases, off-label use isn’t dangerous, nor is it particularly unethical.

GSK was accused of unlawfully promoting Paxil, an antidepressant, for treating patients under the age of 18, even though it lacked FDA approval for pediatric use. GSK participated in “preparing, publishing and distributing a misleading medical journal article that misreported a clinical trial of Paxil that demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.” What was most troubling was that GSK did not balance its study with data from two other studies in which Paxil failed to demonstrate efficacy in treating depression in patients under 18. Typical of this type of marketing, GSK sponsored dinners, lunches, spas, and similar types of programs to promote the off-label use of Paxil in children. It’s also important to note that Paxil includes a “black box warning“, the strongest FDA warning for a pharmaceutical product, that states that antidepressants make increase suicidal ideation and behavior in patients under 18. Continue reading “GlaxoSmithKline fined $3 billion by FDA for improper marketing and unethical behavior”

Placebos cannot replace antipsychotics

As I’ve discussed previously, placebo effects are mostly a myth, and if a new drug has an effect barely above that of a mythical placebo effect, it’s considered a failure. In a recent article in Reuters Health, Rising placebo response seen in schizophrenia trials, Amy Norton states that clinical trials of anti-schizophrenia drugs, in a class of drugs called antipsychotics, are finding lesser effects because patients are responding positively to placebos (that presumably does not contain anything but sugar).

Treating schizophrenia or any psychosis is difficult because different patients respond in different ways to each drug. For some individuals, these drugs can treat many of the symptoms of schizophrenia, including hallucinations and delusions, which allows them to live relatively normal lives. But for some individuals these same drugs have significant side effects, including sedation, weight gain, and hyperglycemia (which can be serious for a diabetic). Eventually, individuals stop using the drugs because of the side effects and their psychotic symptoms return. Continue reading “Placebos cannot replace antipsychotics”

Study confirms iPad’s shortcomings for diagnostic radiology

I’m a huge fan of Apple products.  This blog is being written on a MacBook Pro running WordPress.  I have an iPhone 4 running everything I need.  I don’t own an iPad, but I have had one for a few months a couple of years ago, and I was singularly unimpressed with it, and unless it has suddenly fixed some of its shortcomings, I remain unimpressed.  It’s not just the iPad, it’s the whole genre of computer. Continue reading “Study confirms iPad’s shortcomings for diagnostic radiology”

FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age

One of the consequences of contracting chicken pox (Varicella zoster) is that the virus is not destroyed by the body’s immune system.  Once the symptoms of chicken pox disappear, the virus hides itself in the basal root ganglion, unseen by the immune system.  Even though the body generated an immune response to the original zoster infection, after several decades, the response is either weakened or disappears.

Eventually, due to unknown factors (such as stress or other illnesses), the zoster virus “moves” along the nerve bundles, and causes a second infection with much more serious consequences to the patient.  This second infection is called herpes zoster (despite being the same exact virus, it was given a different name probably because it was originally thought to be two different viruses, but in this case, it’s not given a formal biological binomial name), or more commonly, shingles.  This infection usually happens when the patient is in their 50’s and older, though it can happen at any time. Continue reading “FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age”