On 22 November 2013, the US Food and Drug Administration (FDA) announced that GlaxoSmithKline’s vaccine against H5N1 avian influenza was approved for use should the virus threaten to become epidemic in human populations. GSK’s Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, has also received regulatory approval in Europe and Canada under the brand names, Pumarix™ and Arepanrix™ H5N1, respectively. Though it is not available for commercial use, the vaccine will be added to the national stockpile and distributed by public health officials if such an epidemic were ever to arise.
“This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of disease across the globe,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “Vaccines are critical to protecting public health by helping to counter the transmission of influenza disease during a pandemic.”
The evaluation of safety compared approximately 3,400 adults 18 years of age and older who received the vaccine to about 1,100 adults who received placebo in a multi-center study (a type of study that can be ethically performed when the risk of the preventable disease is expected to be near 0 during the time of trial). The most common side effect reported during the clinical studies among the vaccine recipients was injection site pain. Muscle aches, headache, fatigue and injection site redness and swelling were also common, but no serious side effects were observed. To determine the effectiveness of the vaccine, the immune response was evaluated in about 2,000 of the vaccinated adults. The results of the study established that approximately 91% of individuals between the ages of 18 and 64 years and 74% of individuals 65 years and older who received the two-dose regimen developed sufficient levels of antibodies that would prevent infection by the disease.
According to the Centers for Disease Control and Prevention (CDC), the H5N1 influenza has relatively rare. The CDC has reported that more than 600 human H5N1 cases have been reported to the World Health Organization from 15 countries in Asia, Africa, the Pacific, Europe and the Near East since November 2003. Approximately 60 percent of individuals with documented H5N1 disease have died. Evidence has shown that the virus is highly pathogenic by causing a deadly pneumonia. In addition, there are several studies that have shown that H5N1 can be easily transmitted to humans from avian species through respiratory droplets.
The new vaccine, approved for use in people over the age of 18 who are at increased risk of exposure to the virus, is the first US-approved H5N1 vaccine that contains an adjuvant to boost the body’s natural immune response to the virus, and despite ongoing debate over the safety of such adjuvants, the new vaccine is “the first to show it can confer protection in the event of a pandemic,” Reuters reported.
This vaccine will save lives, many lives, in case of an avian flu epidemic.
If you need to search for scientific information and evidence about vaccines try the Science-based Vaccine Search Engine.
- van Riel D, Leijten LM, Kochs G, Osterhaus AD, Kuiken T. Decrease of Virus Receptors during Highly Pathogenic H5N1 Virus Infection in Humans and Other Mammals. Am J Pathol. 2013 Nov;183(5):1382-9. doi: 10.1016/j.ajpath.2013.07.004. Epub 2013 Aug 27. PMID: 23993779.
- Xu L, Bao L, Deng W, Dong L, Zhu H, Chen T, Lv Q, Li F, Yuan J, Xiang Z, Gao K, Xu Y, Huang L, Li Y, Liu J, Yao Y, Yu P, Li X, Huang W, Zhao X, Lan Y, Guo J, Yong W, Wei Q, Chen H, Zhang L, Qin C. Novel Avian-Origin Human Influenza A(H7N9) Can Be Transmitted Between Ferrets via Respiratory Droplets. J Infect Dis. 2013 Sep 24. [Epub ahead of print]. PMID: 23990570.
Update of 24 September 2013 article to address outbreak at Princeton University.
Meningococcal disease usually refers to a group of diseases caused by the bacteria, Neisseria meningitidis, typically known as meningococcus. The most common illness arising from the bacterial infection is meningococcal meningitis (or just meningitis, even though there are non-bacterial forms meningitis, unrelated to this form). In meningococcal meningitis, the lining of the brain and spinal cord have become infected with these bacteria. These bacteria also have a causative role in other serious infections, such as bacteremia or septicemia, which are blood-borne infections.
Meningococcus bacteria are easily spread through the exchange of respiratory and throat secretions. The bacteria can pass quickly from one individual to another in close quarters, for example, schools and dormitories. Although the disease can be very serious, it can be treated with antibiotics that prevent the more severe forms of the illness and can reduce the spread of infection from person to person.
If meningococcus isn’t treated quickly (or prevented by vaccines), the disease can be disabling or even fatal. And if the infection spreads to the blood, the consequences can be quite severe, requiring hospitalization. Meningococcal disease cannot be treated at home with over the counter or woo-based remedies. In fact, the symptoms of the early stages of the infection can mimic less dangerous infections, and require a physician’s diagnostic tools to rule out other less-serious infections.
(more…) «Why we vaccinate: to prevent…»
One of the cherished strategies of the vaccine deniers is to use the package insert (called a Patient Information Leaflet in EU countries and Instructions for Use in the case of medical devices) to “prove” that vaccines are dangerous. Spend anything more than a couple of minutes in discussion with an anti-vaccinationist, and you’ll get a reference to a particular vaccine’s package insert (PI) as “proof” that it is dangerous, contains dangerous stuff, or is just plain scary.
There are a lot of myths about what PI’s are and aren’t, and what information in them may or may not be useful. It’s time to look at what a PI is and what it really says.
What is a Package Insert?
All of you have probably seen a package insert, it’s a multiple page document that’s included with all real medications, whether prescription or over-the-counter (OTC). Depending on the type of drug, it can be 30-40 pages long, though most are printed on one huge sheet of very thin paper, so that it can be folded tightly and placed in each box that over-packages the drugs container (vial, bottle, etc).
In general, package inserts are part of what is called the “labeling” of the drug, which means all the verbiage that pharmaceutical company may say about the drug. You will hear FDA regulators and individuals in pharmaceutical companies refer to “labeling” all of the time. Labeling is strictly regulated and it includes everything from the box in which the drug is shipped to any print or video advertising. Even what sales reps say to physicians in a sales call is covered by the drug’s labeling. In the USA, the Food and Drug Administration has established very strict rules in the Code of Federal Regulations (CFR) on what can be and cannot be stated in the package insert. There is very little variance from one PI to another one even for very different classes of drugs. The regulations even state the type and size of font used in the PI.
(more…) «Vaccine package inserts–debunking the myths»
Unless you were hiking in the Amazon River jungles, with no access to the internet or American TV, you probably have heard that CNN’s chief medical correspondent, Dr. Sanjay Gupta, changed his mind about marijuana (or “weed” as he keeps saying). Of course, this has become big news, because he’s such a “respected doctor” (why is that? Because he’s on TV?), and because a few years ago he was vociferously anti-cannabis.
I have no doubt that Dr. Gupta’s “conversion” to being pro-weed is genuine (and that his previous stance of anti-weed was similarly authentic), but we need to weed out what is real and what’s just smoke about his comments. His first major point about cannabis* was that the United States Drug Enforcement Agency (DEA) considers marijuana to be a Schedule 1 drug, which is defined as “drugs with no currently accepted medical use and a high potential for abuse.”
Dr. Gupta thinks this classification is ridiculous, and on the surface, many people, even those who are not devoted pot smokers, would probably agree. However, this is a political discussion, at least in the USA, and it is hardly a medical/scientific one. The chances of any political party having the fortitude to correct this classification is about as close to 0 as you can get, without actually stating that there is a 0 chance. But if Gupta wants to make a big deal of this, or that he’s so self-centered that he thinks he’ll change the mind of politicians, more power to him. But for me as a skeptic, it is not the most important thing he says.
In his article, he mentions a young girl who ”started having seizures soon after birth. By age 3, she was having 300 a week, despite being on seven different medications. Medical marijuana has calmed her brain, limiting her seizures to 2 or 3 per month.” This is simply an anecdote of no quality whatsoever. Did he thoroughly investigate her case to determine if the number of seizures actually went down? Do we know that cannabis has anything to do with the change? Is this nothing more than a Post hoc ergo propter hoc fallacy, that just because she consumed cannabis and the seizures decreased does not mean anything about cannabis’ causative properties with regards to this type of seizure. And then, Dr. Gupta continues with the anecdotes by stating, “I have seen more patients like Charlotte first hand, spent time with them and come to the realization that it is irresponsible not to provide the best care we can as a medical community, care that could involve marijuana.” Why do these TV doctors (like Dr. Oz) think that their anecdotes are better than anyone else’s.
Anecdotes are useless because they aren’t controlled, because they are subject to all levels of bias, and because these stories aren’t peer-reviewed. In other words, anecdotes have no value in science-based medicine. Anecdotes do have value in formulating testable scientific hypotheses, but assuming that anecdote=data, and more anecdotes=more data is simply pseudoscientific. I don’t care what Sanjay Gupta writes or says publicly, but providing these stories as “evidence” that marijuana has a medical benefit is essential like telling me that he observed homeopathy (which is just water) working. It’s laughable.
One of the more ironic memes on the internet is how pharmaceutical companies make so much money (and they do), with the false conclusion that somehow all that money means that they’re not really interested in providing drugs that are safe and efficacious. Then, those same memes will claim that “natural supplements” are healthier and better, while they ignore the profit motive of supplement pushers (henceforth called Big Herbal).
The National Center for Complementary and Alternative Medicine (NCCAM), an abomination that pushes fraudulent science, reported that in 2007, US adults spent $33.9 billion on visits to complementary and alternative medicine (CAM) providers and for purchases of CAM products, classes, and materials. About $14.8 billion of that spending was on non-vitamin, non-mineral, natural products, such as fish oil, glucosamine (no evidence of effectiveness), and Echinacea (no evidence of effectiveness). What is surprising is that this $14.8 billion is about ⅓ of what is spent on prescription drugs. Finally, about $4.4 billion was spent on herbal supplements, which are supplements that use botanical products based on some historical or current belief that the products have some ability to treat some disease or symptom. Of course, sometimes these beliefs are myths, or even errors, like when a Swiss CAM products company misunderstood someone and believed that Native Americans used Echninacea for treating colds. They didn’t.
(more…) «Herbal supplements–unproven, unregulated, unsafe»
You’ve probably seen their commercials spread over all of the major TV networks. Beautiful scenes. Well-kept hospitals which often to appear to be near empty. And an anecdote or two or three from presumably real patients who describe their experience at Cancer Treatment Centers of America (CTCA), a private, for-profit operator of cancer treatment hospitals and outpatient clinics which provide both conventional and alternative medical treatments. Included in their treatment plans are chiropractic and naturopathy, neither of which have any evidence whatsoever in providing any healthcare benefit to patients, let alone those suffering from cancer.
Reuters recently published an in-depth report on the validity of the claims that are made by CTCA in its advertising. Here are some of the ones specifically mentioned:
- For breast cancer, CTCA claims that its survival rate after 3.5 years post-diagnosis is about 42%, compared to the National Cancer Institute’s SEER (Surveillance Epidemiology and End Results) Program result (more or less a nationwide average) of about 29%. That’s a 13% improvement.
- For prostate cancer, CTCA claims that its 4 year survival rate is 20 points higher.
- For advanced colon cancer, CTCA claims that its 1.5 year survival rate is 11 points higher.
(more…) «Cancer Treatment Centers of America…»
The US Food and Drug Administration recently announced (pdf) that it had cleared 35 new drugs during 2012, of which 31 were novel therapies. This is in addition to the literally hundreds of approvals for changes in already approved drugs for changes in packaging, manufacturing, and dozens of other reasons.
In no particular order, here are the top 10 most interesting of the approvals based on my subjective viewpoint, which includes innovativeness, seriousness of disease, and other random factors. In others, no different in importance than all those end-of-year top 10 movie lists. So here we go:
(more…) «2012 Top Ten list for…»
In a strange decision, the United States 2nd Circuit Court of Appeals, which has jurisdiction over Connecticut, New York, and Vermont, ruled that a drug sales representative who promotes “off-label” uses of a particular drug is exercising their “freedom of speech.” The Court decided in a 2-1 vote, in United States v. Caronia (pdf), that the criminal conviction of Alfred Caronia, a former sales representative for a pharmaceutical company, be vacated. The case was an appeal of the sales representative’s conviction for promoting an off-label use of the drug Xyrem, which is approved for treatment of narcolepsy. The Court stated that “we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.”
The Court also found that the FDA allows off-label use by physicians, but “prohibits the free flow of information that would inform that outcome,” while “the government’s prohibition of off-label promotion by pharmaceutical manufacturers provides only ineffective or remote support for the government’s purpose.” The Court also ruled that it construes “the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.” It also stated “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”
(more…) «Court says Freedom of Speech…»
A few months ago, I wrote about the role of supplements, mainly vitamins and other nutrients, in preventing cancer. Conclusion: they didn’t. To quote Martinez et al., who published a review of dietary supplements and vitamins in cancer prevention,
Nutritional supplementation is now a multibillion-dollar industry, and about half of all US adults take supplements. Supplement use is fueled in part by the belief that nutritional supplements can ward off chronic disease, including cancer, although several expert committees and organizations have concluded that there is little to no scientific evidence that supplements reduce cancer risk. To the contrary, there is now evidence that high doses of some supplements increase cancer risk. Despite this evidence, marketing claims by the supplement industry continue to imply anticancer benefits. Insufficient government regulation of the marketing of dietary supplement products may continue to result in unsound advice to consumers. Both the scientific community and government regulators need to provide clear guidance to the public about the use of dietary supplements to lower cancer risk.
All those expensive supplements, most of which have broad and unproven claims made about them, do precious little for cancer. And some actually increase the risk of certain types of cancer.
(more…) «Multivitamins–big money, no effect on…»
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.
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.)
If you spend any amount of time on Twitter, Facebook, or just researching cancer treatments on the internet, you will run across someone claiming that smoking pot, eating pot, hemp oil (which is manufactured from the seeds of Cannabis plants that don’t contain much THC, or tetrahydrocannabinol, the active hallucinogenic agent of cannabis), or some other consumption of cannabis will cure or prevent cancer. Of course, it’s effectiveness in reducing nausea and vomiting in chemotherapy has had negative results in some well done clinical trials and some positive results in others. But that has nothing to do with actually curing or preventing the cancer itself, just dealing with the effects of the treatment.
So, is there any evidence out there that actual cannabis or its byproducts have any effect on cancers? Before we start, let’s remember that there are 100 to over 200 different types of cancer (the actual number depends on how some researchers subdivide some types) in humans. And each of these different cancers have different pathophysiologies, different genetics, different prognoses, different causes, and different treatments. In other words, it is not one singular disease with one unified course of treatment. Always be skeptical when someone makes some claim that “XYZ cures or prevents cancer”, because that’s going to be nearly impossible. Every cancer is so different with such different physiology, there is just never going to be a magic pill.
(more…) «Marijuana and cancer–what are facts…»
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.
(more…) «GlaxoSmithKline fined more-link billion by…»
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.
(more…) «Placebos cannot replace antipsychotics»
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.
(more…) «Study confirms iPad’s shortcomings for…»
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.
(more…) «FDA approves Zostavax vaccine to…»
Wise move on the part of the FDA.