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Problems Discovered AFTER Licensing

Updated: Apr 7, 2022

Chapter 7: Article 1

Let's diverge briefly from the vaccine discussion, and revisit the Vioxx catastrophe. FDA declared Vioxx a safe medication in 1999, when in fact it caused heart attacks and death. Merck withdrew Vioxx from the market in 2004. The New York Times explains that since Vioxx's 2004 withdrawal, Merck has since been criminally convicted and criminally fined for their illegal marketing actions

It has been said that Vioxx may have killed more Americans than were killed fighting in the Vietnam War. In a Globe and Mail article, it states that American Vioxx deaths are estimated to be between 39,000 and 61,000. Of course that is only a small fraction of the deaths, recognizing that Vioxx was a medication that was used worldwide, not just in the United States. 

In Ch2: Article 2 I explained that David Graham testified before the USA government to explain how both the pharmaceutical company, Merck, and the FDA held evidence and ignored it, evidence which showed the drug was killing thousands of people. Unfortunately, because Merck and the FDA followed deficient FDA laws, neither the FDA or Merck were charged with committing murder,

Though Merck did voluntarily plead guilty to a misdemeanour for knowingly and improperly marketing their medication, they maintain that they were unaware before 2004 that Vioxx was causing harm. That claim is the subject of ongoing debate.

The VIGOR study, at the heart of this debate, was conducted by Merck and it began shortly before Vioxx was approved for public use in May 1999. The study was completed a year and a half later. It was executed to test whether Vioxx was less damaging to the stomach, compared to a different pain medication, naproxen, which is an over-the-counter drug also known as Aleve. The VIGOR study's data noted a significant difference in heart attack rates, between Vioxx recipients and naproxen recipients. In Graham's 2004 testimony to US Government, he discussed the early Vioxx studies (VIGOR and 090), which both indicated a possible heart damage signal, saying:

Prior to approval of Vioxx, a study was performed by Merck named 090. This study found nearly a 7-fold increase in heart attack risk with low dose Vioxx...In November 2000, another Merck clinical trial named VIGOR found a 5-fold increase in heart attack risk with high-dose Vioxx. 

An NPR article explains how Merck initially reacted to the heart signal of the VIGOR study:

November 1999: At the second meeting of the VIGOR safety panel, the discussion focuses on heart problems. As of Nov. 1, 1999, 79 patients out of 4,000 [2%] taking Vioxx have had serious heart problems or have died, compared with 41 patients taking naproxen. The minutes of the panel's November meeting note that "while the trends are disconcerting, the numbers of events are small." 

A Forbes article provides more detail about the earlier 090 study, stating:

..."a previous study compared 390 patients taking Vioxx to 588 patients taking a placebo. The study, called 090, showed that five, or 1.3%, of patients taking Vioxx had heart attacks or strokes, compared to one, or 0.2%, in the placebo group. Although those numbers are small, they were statistically significant"...

Internal Merck documents reveal that as a result of the heart data from the VIGOR study, Merck found the signal concerning enough to consider conducting a heart specific study, to learn definitively whether or not Vioxx was causing heart damage. A New York Time’s article explains (emphasis mine):

In May 2000, executives at Merck...made a fateful decision.

The company’s top research and marketing executives met to consider whether to develop a study to directly test a disturbing possibility: that Vioxx, a painkiller, migt pose a heart risk. Two months earlier, results from a clinical trial conducted for other reasons had suggested such concerns.

But the executives rejected pursuing a study focused on Vioxx’s cardiovascular risks...the scientists wondered if such a study...was even possible. Merck’s marketers, meanwhile, apparently feared it could send the wrong signal about the company’s confidence in Vioxx.

I find the language used by the New York Times article, to describe what was discussed in that May 2000 meeting, very eerily familiar. If I rephrase the bolded statements above, slightly differently, you might see what caught my attention. Merck conflated pursuing targetted testing with the implication that industry lacked confidence in the product. Obviously a “lack of confidence” would generate public alarm, resulting in the public choosing to not use Vioxx. Merck denies that their marketing team’s fear influenced the final decision, to not complete the targetted testing.

Fears that targetted testing would negatively affect public confidence was also expressed in the 2004 IOM review on vaccines and autism (explained in Ch 3 Article 4). To remind you, the IOM stated that conducting targetted autism research, using “an unsubstantiated hypothesis to question the safety of vaccination,” such action could deter the public away from vaccinating. The IOM’s recommendation to US government was to refrain from conducting targetted research and instead focus research endeavors more broadly.

Merck is also the manufacturer of the MMR-II vaccine, one of the vaccines in the hot seat in the early years of the vaccine/autism debate (between 1998-2004).

It’s important to watch for patterns – involved parties, statements made, underlying motivations and biasses, and actions taken. I believe a pattern is emerging here.

Merck’s action related to Vioxx, their unwillingness to follow through with additional targetted testing has been interpreted by many as willful ignorance. Might the government’s action, refusing to conduct targetted research on vaccine safety, make them guilty of doing the same?

So, instead of proceeding with a Vioxx study that could have definitively concluded whether or not the drug was causing heart damage, Merck instead changed course and theorized that naproxen likely had a protective effect on the heart, like aspirin. A 2004 New York Times article stated:

[Merck] never directly tested the theory that it used to explain the worrisome results of the clinical trial in 2000. Merck was criticized for what some charged was playing down the drug's possible heart risks; in one case, it received a warning letter from the Food and Drug Administration for minimizing "potentially serious cardiovascular findings." And when outside researchers found evidence indicating Vioxx might pose dangers, Merck dismissed their data.

In 2001, Dr. Deepak L. Bhatt, a cardiologist at the Cleveland Clinic, proposed to Merck a study of Vioxx in patients with severe chest pain. Merck declined, saying the patients proposed for the study did not reflect typical Vioxx users. In Dr. Bhatt's view, the company feared what it might find if it directly examined the dangers of Vioxx, one of Merck's biggest products, with sales last year [2003] of $2.5 billion.

"They should have done a trial like this," Dr. Bhatt said. "If they internally thought this drug was safe in patients with heart disease, there was no reason not to do it."

According to David Graham, the FDA should have done more, but because of the culture that favours industry interests, the FDA chose to do nothing at the expense of public health. In his 2005 interview he stated:

As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent. Unfortunately, that is the way the FDA is currently structured.

...For industry, every day a drug is held up from being marketed, represents a loss of one to two million dollars of profit. The incentive is to review and approve the drugs as quickly as possible, and not stand in the way of profit-making. The FDA cooperates with that mandate.

...The FDA assumes the drug is safe and now it's up to the company to prove that the drug isn't safe. Well, that's a no-brainer. What company on earth is going to try to prove that the drug isn't safe? There's no incentive for the companies to do things right.

What happened with Vioxx is a perfect example of how the manufacturer will NOT go out of their way to thoroughly look for a drug's harm. Despite two studies, 090 and VIGOR, showing a 7x and 5x greater risk of heart attack in Vioxx recipients, nothing was done by the FDA or Merck for four more years, and unfortunately, according to current FDA regulation, this is not a crime. VIGOR concluded that naproxen offered protective effects that only made it appear Vioxx was causing heart damage. Merck's "belief"in this unproven theory was both catastrophically irresponsible of them and wildly profitable for them.

How the Vioxx Catastrophe Relates to the Vaccine Debate

As explained in Ch5: Part 1, long term health outcomes in the vaccinated population are never studied, EVER, neither before nor after the vaccine is licensed for widespread public use. The USA Centers for Disease Control and Prevention (CDC) has stated:

Observing vaccinated children for many years to look for long-term health conditions would not be practical, and withholding an effective vaccine from children while long-term studies are being done wouldn’t be ethical.

In that article I linked to a Tedx Talk given by Dr. Christine Stabell Ben. She said:

In Guinea Bissau...we follow 200,000 people with regular home visits, and ... we started doing what no one else had done before, we evaluated the effect of vaccines on overall health ... when we started looking at the effect of vaccines on overall health, it quickly became clear that there was something wrong, something was clearly missing in this equation.

The safety testing a vaccine maker performs is extremely limited (see parts Ch5: Article 2 and Ch5: Article 3  for more details). The FDA is complicit in allowing minimal testing to happen. Within their Code of Federal Regulations 21 CFR 201.57, pharmaceutical drugs need "substantial evidence" demonstrated through "adequate and well-controlled studies,"vaccines aren't held to that same standard. Vaccine studies need not meet the standard of "adequate and well controlled." 

Despite a lack of study looking at long term health outcomes, and despite inadequately controlled testing, sometimes it becomes obvious after licensing that unexpected and unwanted health changes are occurring in the population as a result of a vaccine. That was the case in Europe in 2010/11 following the 2009 pandemic immunization program. We'll dive into those details over the next few articles.

CONTINE to the next article, Ch7: Article 2

Article Sources - Vioxx Information

  • FDA - All FDA information on Vioxx Here

  • 1999 -Original Vioxx Package Insert Here

  • 2001 - Change to Vioxx Label, showing the addition of a "Precaution" for cardiovascular effects as a result of the VIGOR study Here

  • 2016 - Change to the Vioxx Label - showing the addition of a prominent and emphasized warning for cardiovascular events Here

  • The VIGOR Study completed in 2000 Here

  • David Graham's 2005 study published in the Lancet on the Risk of Sudden Cardiac Death from Vioxx Here Additional Article Sources

  • 2004 - David Graham Testimony to US Government Here

  • 2005 Interview with David Graham Here

  • New York Times - Merck fined $950 million for illegal marketing Here

  • Globe and Mail - Vioxx may have killed 39,000-61,000 Americans Here

  • New York Times - What Merck Knew and When Here

  • NPR Article - Merck concerned by number of heart attacks in VIGOR Here

  • Forbes - The VIGOR and 090 studies both noted higher heart attacks Here

  • CDC explains that long term studies looking at long term health outcomes in a vaccinated population has never been done Here

  • Tedx Talk with Christine Stabell - she explains their research, that her team looked at long term health outcomes following vaccination Here

  • FDA Regulations showing vaccine clinical testing is inferior compared to pharmaceutical drug testing Here

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