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?”

The myth of getting the flu from the flu shot

Obama getting his flu vaccination.

As part of my history in medical industry, I used to train sales representatives on new medical products and procedures. Because these sales reps were in hospitals and physicians offices, many medical companies (yes, Big Pharma), a condition of employment was that they were required to be up-to-date on their vaccinations including the seasonal flu vaccine. Not all companies did this, and not all companies made it mandatory, but there was nothing worse than having a large percentage of the sales force out of commission sick with flu, especially if a new product was being launched. And doctor’s offices did not want sales reps walking into their offices sick either, so it was a good business practice. Exemptions were just not given, because it was a job requirement stated clearly in the written job offer, so they had a choice to not take the job. 

It was ironic that these well-paid, well-educated mouthpieces for Big Pharma would make up the most silly excuses for not wanting the flu vaccination. The number one reason, that I would hear, is that “the flu shot always gives me the flu.” And that’s just not these sales reps who would make up this claim, but apparently in a 2010 CDC poll, 62% of Americans also believe the flu vaccine can actually cause the flu. 

Well, let’s just blow that myth right out of the water:

  • According to the CDC, “No, a flu shot cannot cause flu illness. The viruses contained in flu shots are inactivated (killed), which means they cannot cause infection. Flu vaccine manufacturers kill the viruses used in the flu shot during the process of making vaccine, and batches of flu vaccine are tested to make sure they are safe.”
  • In a 2000 study on flu vaccine effectiveness, 2.2% of vaccine recipients vs. 4.4% of placebo recipients had laboratory confirmed influenza illness in 1997-1998. During the next flu season, 1% of vaccine recipients and 10% of placebo recipients had influenza illness. So, the risk of getting the flu is much higher in the non-vaccinated group.
  • According to the ACIP (Advisory Committee on Immunization Practices), rare symptoms include fever, muscle pain, and feelings of discomfort or weakness, which may mimic flu symptoms, but last only 1-2 days (as opposed to flu which may last 7-10 days).

So, if you think that the flu vaccine gives you the flu, it really doesn’t. And I’m not the only one saying this:

Get your flu shot. Because, you know, Vaccines Save Lives.

Use the Science-based Vaccine Search Engine.

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”

Texas is officially the most anti-science state in America

As long as the Republican Party runs the state of Texas, then its strategies and beliefs are equal to the beliefs of the state itself. The Texas Republican Party just published its platform of beliefs (pdf), filled with nonsense, craziness, and denialism. I’ll stick with the anti-science junk, but you can amuse yourself with everything from immigration to voter ID.

Protection from Extreme Environmentalists – We strongly oppose all efforts of the extreme environmental groups that stymie legitimate business interests. We strongly oppose those efforts that attempt to use the environmental causes to purposefully disrupt and stop those interests within the oil and gas industry. We strongly support the immediate repeal of the Endangered Species Act. We strongly oppose the listing of the dune sage brush lizard either as a threatened or an endangered species. We believe the Environmental Protection Agency should be abolished.

Obviously, a knock against global warming, or at least, that Texas’ oil and gas interests take precedence over global warming, endangered species, and the EPA! Apparently, the dune sage brush lizard is of critical importance to the Texas political process!

 RU 486 – We urge the FDA to rescind approval of the physically dangerous RU-486 and oppose limiting the manufacturers’ and distributors’ liability.

It is not physically dangerous, because out of 1.52 million uses, there were around 2200 adverse events (pdf), or around 0.14%. That’s less than smoking. Or drinking. Or walking across the street.

Morning After Pill – We oppose sale and use of the dangerous “Morning After Pill.”

No. Not dangerous either.

Fetal Pain – We support legislation that requires doctors, at first opportunity, to provide to a woman who is pregnant, information about the nervous system development of her unborn child and to provide pain relief for her unborn if she orders an abortion. We support legislation banning of abortion after 20 weeks gestation due to fetal pain.

There is little evidence that a fetus feels pain prior to 30 weeks of gestation. This is merely a method for anti-abortion and anti-women individuals to promote some sort of viability in a fetus.

Religious Freedom in Public Schools – We urge school administrators and officials to inform Texas school students specifically of their First Amendment rights to pray and engage in religious speech, individually or in groups, on school property without government interference. We urge the Legislature to end censorship of discussion of religion in our founding documents and encourage discussing those documents.

Actually, the First Amendment prevents the establishment of religion by government, which includes government sponsored institutions like public schools. 

Health Care and Nutritional Supplements ― We deplore any efforts to mandate that vitamins and other natural supplements be on a prescription–only basis, and we oppose any efforts to remove vitamins and other nutritional supplements from public sale. We support the rights of all adults to their choice of nutritional products, and alternative health care choices.

Because real medicines that actually do real things require regulation. Vitamins and supplements that don’t do anything and have no evidence supporting their efficacy prefer not to be regulated. And the Republicans want that dishonesty to continue.

Immunizations ― All adult citizens should have the legal right to conscientiously choose which vaccines are administered to themselves or their minor children without penalty for refusing a vaccine. We oppose any effort by any authority to mandate such vaccines or any medical database that would contain personal records of citizens without their consent.

Vaccines save lives. Any other rationalization does not save lives.

Well there’s your Republican lunatics in Texas. Maybe one day the demographics change enough that a more progressive group of people run the state, removing the insanity.

Identifying science denialism and pseudoscience

Science denialism, a form of pseudoscience, is everywhere these days. There’s the oft-discussed vaccination denialists who refuse to vaccinate children because they believe that vaccines cause some condition (usually autism), and Big Pharma hides evidence. Or AIDS denialists who believe that HIV doesn’t cause AIDS. Or global warming deniers who think that either global warming isn’t happening or, if it is, it’s not caused by human activities. Or evolution denialists, like Ken Ham, who think that one hundred years of scientific research can be ignored for a book that was written 5000 years ago to help illiterate pastoral farmers understand the natural world. It’s not just science, of course, there are Holocaust deniers, who think that no Jews were killed by the Nazis. There are even 9/11 deniers (usually called truthers) who think that Big Government (probably in league with Big Pharma) is hiding the truth about what really happened on 9/11. Continue reading “Identifying science denialism and pseudoscience”

Why do Americans hate Gardasil?

In next week’s issue of Forbes, Matthew Herper, the magazine’s medical editor, penned the article, The Gardasil Problem: How The U.S. Lost Faith In A Promising Vaccine, an insightful analysis of why Gardasil, the vaccine for human papillomavirus (HPV), has not become as important to vaccination strategies as measles or whooping cough.  All vaccines keep you alive, even if the disease does not appear to be scary.  There’s a belief, especially amongst the anti-vaccination crowd, that measles is just a few spots, and there are few risks to being infected.  The risk of severe complications is small, but significant.

On the other hand, the HPV vaccine does one thing and does it well–it prevents an HPV infection.  Human papillomavirus, a sexually transmitted disease, causes 70% of cervical cancers, 80% of anal cancers, 60% of vaginal cancers, and 40% of vulvar cancers.  It also prevents the majority of HPV caused oral cancers.  In other words, these diseases are in a different league of danger.  And they can be prevented. Continue reading “Why do Americans hate Gardasil?”

CDC makes recommendations on the use of HPV vaccine in males

The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of males aged 11 or 12 years with HPV4 administered as a 3-dose series (recommendation category: A, evidence type: 2§). The vaccination series can be started beginning at age 9 years. Vaccination with HPV4 is recommended for males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose series. Males aged 22 through 26 years may be vaccinated. Continue reading “CDC makes recommendations on the use of HPV vaccine in males”

The Zombie Apocalypse or vaccine myths that won’t die

Pseudoscience pushing individuals can be likened to zombies.  They have no brains, and their only goal in life is to eat the brains of those who don’t adhere to their position.  The anti-vaccine crowd are my favorite zombies, because the metaphor can be further extended because the victims of these zombies can die (the logical result of non-vaccination).

Yesterday, I ran across this YouTube video by someone called the PatriotNurse.  As an aside, WordPress (the blogging software I use) allows for embedding of YouTube videos, which is perfectly within my programming capabilities.  But for some unknown, and admittedly perplexing reason, PatriotNurse disabled the embedding feature.  Lacking evidence, I won’t speculate as to why.  She also has disabled comments to her video by stating, “The comments are OFF for many reasons. Foremost is that I refuse to be abused for a contrarian viewpoint that goes against mainstream “Sickcare.”  In other words, she refuses to allow her zombie ideas to be shown in the bright light of the day.  Also, if you look at her other videos, well, let’s just say I’m concerned about who trained her as a nurse and who would currently employ her, but that’s not the point here.

Basically she uses the standard repertoire of unsupported claims, canards and fairytales that most vaccine denialists use to make their case.  Every once in a while we should list out all their claims, debunk them, and refer to them in the future.  The anti-evolution crowd, which probably relies upon 100 times more myths than the anti-vaccine group, has spawned a few websites that list out creationist claims, then thoroughly debunks them.  At this time, the anti-vax websites focus on just a few claims, all of which are easily dismissed.

In order of weakness of the argument, here we go!

  • After my friend’s neighbor’s cousin’s sister-in-law’s daughter was vaccinated, she got….This argument is a typical example of the logical fallacy called post hoc ergo propter hoc or post-hoc fallacy, a Latin phrase which literally means, “after this therefore because of this.”  In other words, just because one event follows another event, one cannot conclude the first event caused the second event.  Or even that they are even peripherally related.  One of the worst mistakes in science is conflating correlation (this event happens when another event happens) with causation (that one event actually causes the second event).  Let’s put it this way.  I’m sure a certain percentage of children who are vaccinated break there arms in a fall, get a cold, or draw on the wall with a pen.  I’m sure some of us recall such an event.  But are they related to the vaccination?  Well, I’m sure someone would make a case that the child going to the pediatrician’s office to get a vaccine picks up a cold from another kid, but that’s a perfect example of pure coincidence.  In other words, without providing a logical mechanism for the correlation, then causation is far from proven.
  • Everyone I know who gets a vaccination gets sick, paralyzed, or (put almost anything here).  Similar to the post-hoc fallacy, it depends on a confirmation bias, that is, individuals look for evidence that supports their own beliefs or assumptions, ignoring all else.  Of course, the vast majority of children or adults that get vaccinated do not have any serious side effects (nota bene: I chose one of literally thousands of articles that dismiss any serious side effects from vaccines).  Essentially, this claim barely rises above personal anecdote.
  • Vaccines cause autism.  I’m not even sure this claim should be discussed because it’s been so thoroughly and scientifically quashed, it is almost sad that it’s still used as an excuse to not vaccinate.  But since this is supposed to be a thorough list, I’ll go through the debunking again.  Andrew Wakefield, who first invented the claim in a article in the British medical journal, The Lancet. Eventually, several co-authors removed their names from the paper in 2004, and finally the article was fully retracted by the journal in 2010.  Finally, Wakefield was found to be a fraud.  Still, the anti-vax conspiracists believe that vaccines cause autism, despite substantial evidence in peer reviewed journals (pdf file).  Since all the evidence dismisses the claim, but it’s still trotted out by anti-vaxers, one can only reply with the evidence.
  • Vaccines contain mercury.  In the past, a mercury-organic compound called thimerosal was used as a preservative in certain vaccines, especially those that were labeled for multiple doses (vaccines vials are often doses of 10).  But to be perfectly clear, thimerosal is not metallic mercury floating in the vial, it is a compound that is bound up in a rather large organic molecule, meaning that the mercury itself is inaccessible to the body and will be excreted.  Cans of tuna, a typical childhood meal, contains several times more mercury in the form of methyl mercury, which is easily absorbed by the gut and can be dangerous.  Vaccines that contain thiomersal contain about 25µg (or mcg or micrograms) of mercury.  A 125g (about 4 oz) portion of canned tuna contains about the same amount.
  • Vaccines contain mercury–but injected is worse than eating it.  The discussion then moves to the myth that ingesting mercury from foods is somehow better than getting it injected.  Before we continue, remember the mercury in vaccines is thiomersal which is bound up by a relatively large organic molecule.  This is a method used in a lot of pharmacological applications to isolate toxic metals from the body, but still derive a benefit from them.  Contrast agents used in enhanced radiology exams (like CT’s) contain iodine, also fairly toxic.  The organic molecule protects the patient from the toxic effects, while soon after the exam (usually within 30 minutes), the contrast agent is excreted.  The same with thiomersal.  Ingested mercury, in the form of methyl mercury (found in most fish), is actually absorbed faster, and methyl mercury also disperses to more organ systems because it mimics an essential amino acid, methionone. There are no physiological mechanisms that block the uptake of a small molecule like methyl mercury, so the effect might be worse than thiomersal.
  • Vaccines contain mercury, oh my.  Except, they don’t contain mercury, save for some flu vaccines.  So, not only eating tuna sandwiches is a larger mercury source, vaccines is not a mercury source.
  • Vaccines contain aluminum.  So we dispensed with the mercury myth, but a new one shows up.  In this case, vaccines do contain aluminum, in the form of aluminum salts.  It is used as an adjuvant to increase the immune response of the vaccine, an important requirement to confer immunity to the disease.  However, more aluminum comes from food sources (like breast milk) than from vaccines.  “During the first 6 months of life, infants could receive about 4 milligrams of aluminum from vaccines. That’s not very much: a milligram is one-thousandth of a gram and a gram is the weight of one-fifth of a teaspoon of water. During the same period, babies will also receive about 10 milligrams of aluminum in breast milk, about 40 milligrams in infant formula, or about 120 milligrams in soy-based formula.
  • Vaccines bypass the gut which is our best immune defense system.  It’s hard to disprove something that has no basis in real physiology.  If this claim were true, of course, we’d never be afflicted by most pathogens, and we wouldn’t need vaccines.  The adaptive immune response to immunizations requires interaction with the internal organs and blood.
  • Too many vaccinations. While listening to video (I couldn’t bear to watch), PatriotNurse mentioned another old canard about too many vaccine doses given to infants and toddlers.  Apparently, the anti-vaccination zombies need to run from one debunked myth to another one.  Paul Offit, much hated by the anti-vaccine gang, has stated that “Vaccines do not overwhelm the immune system. Although the infant immune system is relatively naive, it is immediately capable of generating a vast array of protective responses; even conservative estimates predict the capacity to respond to thousands of vaccines simultaneously”, that “multiple vaccinations do not weaken the immune system,” and that “vaccines represent a minute fraction of what a child’s immune system routinely navigates; the average child is infected with 4–6 viruses per year.”
  • It’s a Big Pharma conspiracy.  This conspiracy is huge, because it includes the CDC, FDA, major medical journals, physicians, and, of course, the pharmaceutical industry.  Of all the logical fallacies, the Appeal to a Grand Conspiracy is one of the most annoying.  It is difficult to disprove, because the vaccine conspiracists don’t provide any real evidence for their assertion.  Since extraordinary claims require extraordinary evidence, their claim lacks even bad evidence.

There might be other arguments that they use, and I’ll be finding them and debunking them.  In the meantime, I’m going to create a vaccine FAQ that debunks these things.

Totally Drug-Resistant Tuberculosis in India

Totally Drug-Resistant Tuberculosis in India.

Along with HIV and malaria, tuberculosis (TB) is one of the most dangerous diseases in the world.  According to the World Health Organization, there were 8.8 million new worldwide cases of TB, along with 1.4 million deaths in 2010.  TB is difficult to treat, usually taking over six months with antibiotics that sometimes have difficult side effects.

Also, because of low patient compliance, misdiagnosis, and other issues, multi-drug resistant (MDR) and extensively drug-resistant (XDR) versions of TB can arise in a population. MDR is resistant to the first-choice drugs, requiring treatment with a larger cocktail of  one or more of the nine different “second-line” antibiotics, which are less effective, have more adverse effects, and can take much longer to effect a cure, up to 2 years or more. XDR TB is resistant to the three first-line drugs and several of the nine antibiotics usually considered as second line choices.

As the article states:

The vast majority of these unfortunate patients seek care from private physicians in a desperate attempt to find a cure for their tuberculosis. This sector of private-sector physicians in India is among the largest in the world and these physicians are unregulated both in terms of prescribing practice and qualifications. A study that we conducted in Mumbai showed that only 5 of 106 private practitioners practicing in a crowded area called Dharavi could prescribe a correct prescription for a hypothetical patient with MDR tuberculosis. The majority of prescriptions were inappropriate and would only have served to further amplify resistance, converting MDR tuberculosis to XDR tuberculosis and TDR tuberculosis.

The spread of this disease could be quicker than some other infectious disease (like HIV), because of how easily it’s spread (one patient can infect up to 15 others before diagnosis and treatment), and, of course, the lack of viable antibiotics for XDR TB.

Right now, the infection seems to be in a small subgroup of TB patients in India (and Iran) in a border region that has poor medical care.  However, given the lack of effective antibiotics means that we’re all in this together.

The interesting fact about the title of the article–the authors seem to have invented a new subset of TB, Totally Drug Resistant.