The twisted illogical gambits of the antivaccination cult

merck-vioxx-now-gardasilOK, let’s connect the dots. Merck produced and marketed Vioxx. Vioxx is bad. Merck produces and markets Gardasil. Gardasil is bad.

Yes, this is the logic of the vaccine deniers–associate Big Pharma with one of the mistakes it made in the past, then use that association to convince themselves everything produced by that Big Pharma company to be evil. This is a perfect example of the logical fallacy of Poisoning the Well, which states that one side of an argument pre-provides information that could produce a biased opinion of the reasoning, positive or negative.

Examples of this poisoning of the well abound throughout the antivaccination cults. There are numerous tired, hackneyed myths about the drug thalidomide, which, in the 1950’s was marketed by a German pharmaceutical company for the treatment of morning sickness in pregnant women (as one of its many indications). At that time, medications were not as strictly controlled as they are today for use during pregnancy, and thalidomide was given out rather freely to pregnant women. Unfortunately, nearly 10,000 children (half of them born in the former Federal Republic of Germany, also known as West Germany, but none in East Germany, because the communists did not approve it for use) were born with birth defects as a result of the drug. 

Here’s an important point. Despite significant pressure from politicians and Big Pharma, the FDA, specifically the Director of the FDA at the time, Dr. Frances Oldham Kelsey, blocked approval of thalidomide in the USA, because it did not have the testing that proved it was not dangerous to the fetus. This showed the weakness of the drug approval process at that time, and led to better and more complex rules for drug testing. But Dr. Kelsey is one of the heroes of modern medicine for standing up for better drug testing. And saving a lot of American babies from birth defects.

But let’s fast forward to today. Thalidomide is not some drug that’s laying on the waste heap of failed drugs. It is part of the standard treatment for leprosy, a horrible disease in many parts of the world. Because of our understanding of how thalidomide did harm the developing fetus, scientists began to examine its power in treating other diseases. For example, thalidomide is part of the chemotherapy regimen that is used to treat multiple myeloma, a type of cancer of plasma. Modern treatments, which include thalidomide, has increased survivability from 3-4 years by almost double to 5-7 years or more. So if you’re going to invent a vacuous strawman argument, trying to poison the well about pharmaceutical companies and the FDA, well, using thalidomide as your well-poisoner is not going to fly in an intelligent conversation.

But let’s get back to Vioxx, since it’s more recent. And it was approved by the FDA.

Vioxx is a medication that was manufactured and marketed by Merck to be prescribed for acute pain from conditions such as arthritis. It was approved by the US FDA in 1999. The drug is in a class called non-steroidal anti-inflammatory drugs (NSAID), which covers a lot of prescription and over-the-counter medications. Vioxx inhibits a specific enzyme called COX-2, which mediates pain. It is a powerful non-narcotic pain inhibitor, and other COX-2 inhibitors were then and are still on the market.

As is normal, Merck ran post-approval clinical trials (some people call them Phase IV or post-marketing trials) to get more data, obviously to sell more of the drug. This is a standard operating procedure for all pharmaceutical companies. During this post marketing study, Merck determined that it was possible that Vioxx users had a potentially higher risk from certain cardiovascular events, such as heart attack. Now, for a little information. Some NSAID’s have cardiovascular protecting effects. Aspirin is an NSAID, and it’s often given as a prophylactic to individuals at risk of heart attacks because it inhibits blood clotting (I’m oversimplifying, because I don’t want to spend 20 paragraphs explaining NSAID’s). 

At this point, Merck’s world exploded as lawsuits and FDA investigations of Vioxx began in 2003-04 as lawyers jumped in to get a piece of the action from lawsuits that resulted from cardiovascular events (such as death) that may have been related to Vioxx. And Merck was by no means an angel in this process. They may have hid some data about these cardiovascular issues, possibly because Merck scientists thought that the control group’s medications were cardio-protective (such as Naproxen, but this isn’t Merck’s responsibility to interpret, it’s the FDA’s), though Vioxx may have provided better pain relief than other NSAIDs. In fact, the FDA’s own outside review panel, made up of physicians, researchers, specialists and others, voted to 17-15 to keep the drug on the market, although the FDA, which does this only rarely, decided to overrule the advisory panel and ordered Vioxx removed from the market.

I find it ironic and somewhat amusing that one of the tropes of the anti-medicine world think that the FDA is in the pocket of Big Pharma, when, in fact, they observe a drug that may be dangerous, whether thalidomide or Vioxx, they move swiftly to prevent it from getting to the market, or pulling it from the market.

A dispassionate view of Vioxx is that it can treat pain if used for a short-term (it is powerful for those types of pain, much better than addictive opioid medications), that in the short-term, it has no different cardiovascular event profile than other NSAID’s, and that it could be an important part of pain treatment. And remember, there are other COX-2 inhibitors on the market today that are almost exactly like Vioxx in risk/benefit. Probably the reason they’re on the market is that they didn’t do some of the things that Merck did with Vioxx. Like hide data.

But in the long history of pharmaceutical companies, what Merck did was more on the line of misinterpretation of data. But, there was a bad part, they may have attempted to hide the fact that they erred in the interpretation of data. One of the things you learn in business, especially in the medical products industry is admit when you goofed, but it’s really bad to hide that you goofed. And that’s where Merck messed up. As for the patients that used Vioxx, I have to first say that all medications have side effects, and Merck should have been more open about those side effects. I’m going to bet that the drug would have been used almost as frequently, but physicians would have monitored more closely their patients. In additions, without substantial clinical trials, and they aren’t going to happen, we cannot know how many of the known cardiovascular events experienced by Vioxx users are related to the drug, or to pre-existing conditions or other factors. Merck has set aside billions of dollars to pay claims, so in the end, they got what they deserved.

But once again, the Vioxx story is extremely complex, and not quite what you think it is. The FDA moved rather swiftly to deal with issue. The FDA withdrew Vioxx from the market, event though once all the issues were known, there was a slight positive benefit to risk computation that could be made for the drug. Was Merck clean? No, but they weren’t exactly pushing a snake oil that didn’t do anything and killed everyone. The regulatory and clinical trial system actually worked, just maybe not fast enough.

Of course, supplement companies make false representations about their concoctions with any testing of safety and effectiveness. And they’re rarely effective, and many are completely unsafe. And they get to almost completely avoid review by the FDA. So, excessive condemnation of Big Pharma is pretty laughable.

merck-cdcEven though the Vioxx story is complex and nuanced, that doesn’t stop the antivaccination troops from Poisoning of the Well.

Merck also makes Gardasil (or Silgard in Europe), an HPV quadrivalent vaccine. It is a vitally important part of the war against infectious diseases, by preventing the transmission of certain types (pdf), specifically 6, 11, 16, and 18, of the human papillomavirus (HPV). Importantly, HPV types 16 and 18 cause approximately 70% of cervical cancers, and cause most HPV-induced anal (95% linked to HPV), vulvar (50% linked), vaginal (65% linked), oropharyngeal (60% linked) and penile (35% linked) cancers. These HPV-related cancers can be prevented as long as you can prevent the HPV infection itself, which are generally passed through genital contact, most often during vaginal, oral and anal sex.

Maybe Merck did mess up up with Vioxx, but Gardasil is a different story. In huge epidemiological studies, Gardasil has been shown to be unconditionally safe. Not a single condition, other than minor adverse effects like fainting upon seeing the needle (I never knew this was an issue, until I started reading papers about vaccines), was found to be causally linked to the Gardasil vaccine. None. So even if you think that Vioxx shows some evil behavior by Merck, and there is quite a bit of debate about that, we have no evidence of it now. And probably, as a result of the Vioxx activity, the researchers at Merck are going to be much more open about their data, which they appear to be doing. Nevertheless, independent researchers are finding nothing untoward about Gardasil.

So, I guess the vaccine denial crowd can try to twist logic around, making Vioxx and thalidomide to be examples of how bad the FDA and Big Pharma are. And then use that as your evidence that vaccines are terrible. Except, I’ll counter with real evidence that stories behind Vioxx and thalidomide are much more complicated, and actually show how well the FDA works. And I’ll counter with boatloads of peer-reviewed, high-quality, scientific evidence that vaccines, no matter which one the antivaccination lunatics want to discuss, are safe and effective. It’s a discussion that I’ll easily win, because we know that the anti-science crowd are lazy, unmotivated, intellectual corrupt fools.

Don’t take from this article that I think that Big Pharma is perfect, and the corporations are run by magical fairies straight out of Disney. The executives of the corporations are tasked to make profits–but, the better managed medical companies combine a ethos of open data and information, along with dismissing the belief that adverse events are nothing more than an accounting issue. And most of the non-executives have a stronger moral fiber believing that they are doing the right thing for humankind. Believe it or not, given the thousands of drugs on the market, the good guys win almost all the time.

 

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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor

Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!