I get an email about Gardasil

hpv posterI get lots of email about my articles that are published here. Sometimes, it’s about grammar or spelling (and the grammar KGB can be uncivil at times). Sometimes, it’s compliments or questions about what I’ve written. Rarely, they’re rude and usually include quite immature comments about the location of my head. However, I recently received an email that is more or less polite, but is filled with so many errors and logical fallacies, that I thought it should be critiqued publicly.

Here are my point-by-point comments about the email:

I stumbled across your blog and could not believe what I was reading about the safety of Gardasil.  As a mother of a Gardasil injured daughter, your profuse endorsement made me skeptical.  I want to begin by saying I am not anti-vaccine;  I am anti-Gardasil.  Continue reading “I get an email about Gardasil”

HPV–early vaccination maximizes effectiveness

 

HPV protesters in Texas.

Human papillomavirus (HPV) is a virus from the papillomavirus family that is capable of infecting humans. Like all papillomaviruses, HPVs establish productive infections only in keratinocytes of the skin or mucous membranes, making it easily transmitted sexually or through other intimate contact. While the majority of the known types of HPV cause no symptoms in most people, some types can cause warts (verrucae). HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced anal, vulvar, vaginal, and penile cancers. The HPV quadrivalent vaccine, also known as Gardasil (or Silgard in Europe), is marketed by Merck. The vaccine prevents the transmission of certain types of HPV, specifically types 6, 11, 16 and 18

Although the safety of HPV vaccine has been thoroughly vetted for safety in studies with large cohorts, the long time period (up to decades) from infection to a diagnosis of an HPV-related cancer has left questions about how to maximize effectiveness of the vaccine which required further research.  Continue reading “HPV–early vaccination maximizes effectiveness”

Tamiflu-does it work

According to the CDC, this year’s flu season is pretty serious in the USA. Current data, shows that about 4.6% of patient visits to health care providers are for influenza like illnesses (ILI). Thirty states and New York City are now reporting high ILI activity; an increase from 24 states last week. Additionally, 10 states are reporting moderate levels of ILI activity. Forty-eight states reported widespread geographic influenza activity for the week of January 6-12, 2013. This increased from 47 states in the previous week. 

2013-flu-outbreak-week-03

 

Although there has been a slight drop-off in ILI visits over the past couple of weeks since the peak in early January, the CDC continues to identify this season as a “moderately severe” one, and supplies in some areas have tight supplies of the flu vaccine.  Continue reading “Tamiflu-does it work”

2012 Top Ten list for new drug approvals

pharmaceutical researchThe 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: Continue reading “2012 Top Ten list for new drug approvals”

Court says Freedom of Speech applies to Big Pharma Sales Reps

pills and pill bottlesIn a strange decision, the United States 2nd Circuit Court of Appeals, which has jurisdiction over  ConnecticutNew 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.” Continue reading “Court says Freedom of Speech applies to Big Pharma Sales Reps”

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?”

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.