When doctors all over the world emphatically state that vaccines are safe and effective, such emphasis implies, "What more is there to consider?"
Well to answer that, we need to look closer at the words safe and effective, by asking "What is the regulation process used to determine whether or not a drug is safe and effective?"
In the US, the Food and Drug Administration (FDA) determines that process. They govern and enforce the laws that the drug makers must follow, determining what clinical testing the manufacturers must complete to prove safety and effectiveness. The FDA also governs how those various clinical trials must proceed (with input given from the manufacturers). Once the manufacturer completes the required drug testing, they then submit the data analysis to the FDA for review, and at that point the FDA determines whether or not more testing is required and whether or not the manufacturer proved safety and effectiveness. The FDA grants drug approval and licensing to only those drugs which have been satisfactorily proven as both safe and effective.
David Graham is a senior scientist who works in the Office of Drug Safety within the FDA. On November 18, 2004, he was called to testify to the US Government about Vioxx, a prescription medication that was used to treat acute pain. His testimony explained how both Merck (the maker of Vioxx) and the FDA were long aware of safety data that implicated Vioxx as potentially causing heart attacks and death.
Vioxx was approved and licensed by the FDA in 1999, after the FDA determined that it was in fact a safe and effective medication. That approval was given despite pre-licensing data (discovered through a Merck study called 090) which showed that Vioxx recipients actually experienced a 7x greater risk of heart attack when compared to the control group. And another Merck study called VIGOR, which was published later in 2000, showed that Vioxx recipients experienced 5x greater risk of heart attack when compared to the control group. Despite the evidence linking Vioxx with fatal heart attack outcomes, the FDA and Merck did little about it. Vioxx subsequently became a drug of choice for physicians, who prescribed it widely to their patients for four more years until 2004. At that time, Merck voluntarily withdrew Vioxx from the market, making the recall one of the biggest in the world's history.
Three years after the recall, in 2007, Merck was forced to pay out $4.85 billion to settle 27,000 lawsuits filed by the Vioxx victims or their surviving family members. In 2011, Merck was also criminally convicted and fined. A New York Times article provided the following details (emphasis mine):
Merck has agreed to pay $950 million and has pleaded guilty to a criminal charge over the marketing and sales of the painkiller Vioxx, the company and the Justice Department said Tuesday [November 20, 2011].
The negotiated settlement, which includes resolution of civil cases, was the latest of a series of fraud cases brought by federal and state prosecutors against major pharmaceutical companies.
So to get back to FDA employee David Graham, and his relationship within the Vioxx catastrophe, a Forbes article is quoted as saying (emphasis mine):
Without Graham, the Vioxx debacle might have been seen as an isolated event. But because he was willing to step into the spotlight, the withdrawal of Vioxx from the market looks like part of a systemic failure to properly weigh the risks and benefits of drugs. To hear Graham tell it, this is part of a systemic failure to address drug safety on the part of the FDA, a story that reaches back over the entirety of his 20-year career at the agency.
That Forbes article hailed Graham a hero, saying, "For his steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses, we're naming David Graham our Face of the Year."
In Graham's 2004 testimony to Governement, he explained that the FDA was actually complicit in the Vioxx catastrophe. During his testimony, he stated to US officials:
The problem you are confronting today is immense in scope. Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.
It is important that this Committee and the American people understand that...Simply put, FDA and its Center for Drug Evaluation and Research [CDER] are broken...
Even though he explains that the FDA is a broken agency, he goes on to say that despite that brokenness, there "is an implicit expectation that the status quo will remain unaltered." Later in his testimony, he goes on to provide a graphic analogy to emphasize just how flawed current FDA regulations are, and how the deficiencies fail the public. In his testimony he stated:
...I want to leave you with [an anology] to illustrate the unreasonableness of CDER’s standard of evidence as applied to safety, both pre- and post-approval...Imagine for a moment that you have a pistol with a barrel having 100 chambers. Now, randomly place 95 bullets into those chambers. The gun represents a drug and the bullets represent a serious safety problem. Using CDER’s standard, only when you have 95 bullets or more in the gun will you agree that the gun is loaded and a safety problem exists. Let’s remove 5 bullets at random. We now have 90 bullets distributed across 100 chambers. Because there is only a 90% chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.
In 2005, following his testimony to Government, David Graham gave an incredible interview. PLEASE read the full two page article linked here, to learn the depth of corruption that Graham explains is happening within drug regulation. Some points that David Graham covers in his testimony and interview are:
the FDA views industry as their client, NOT the public or public health - the FDA works to protect the interests of their client
even though you will always hear the FDA (and other Government Health Agencies) state that a drug’s benefit outweighs its risk of serious side effects, a risk/benefit analysis has never been conducted by the FDA, for any drug they've ever approved
if a risk/benefit analysis were required as part of the drug approval process, many drugs would not be approved, as they’d be deemed not beneficial related to the risk
drug efficacy (effectiveness) testing is good - because the manufacturer has to prove the drug actually works
drug safety testing is very poor - because the manufacturer does not have to prove the drug is safe. Instead, the FDA automatically assumes that all drugs are safe, and the manufacturer then has to prove (with 95% certainty) that the drug isn't safe. Graham explains that proving that level of certainty of danger, in any drug trial, is impossible.
the FDA would need to go through complete reform, in order to become a useful, effective and protective agency
One of Graham's quotes made during that 2005 interview was (emphasis mine):
Since November , when I appeared before the Senate Finance Committee and announced to the world that the FDA was incapable of protecting America from unsafe drugs or from another Vioxx®, very little has changed on the surface and substantively nothing has changed...The people who approve a drug, when they see [later] that there is a safety problem with it, are very reluctant to do anything about it because it will reflect badly on them. They continue to let the damage occur. America is just as at risk now, as it was in November, as it was two years ago, and as it was five years ago.
Though Graham gave this interview in 2005, and this interview was republished again seven years later in 2012, the republished interview begins with an introduction that explains that to date almost nothing has changed within the FDA. If nothing changed during the seven years between 2005 and 2012, when public outcry was at it's highest as a result of the ongoing Vioxx court proceedings, then it's reasonable to assume that no improvements have been made in recent years either.
It needs to be stated now that many of the articles written here on Vaccine101 refer specifically to the failures within FDA regulation. However, what needs to be emphasized here is that the problems identified within the FDA, are not solely isolated to US drug regulation. American health agencies, which include the FDA, CDC, NIH, etc, they are all viewed as the expert health authorities in the world. The policies, practices and statements made by these American agencies are relied upon heavily and reiterated regularly by other countries. Recognizing that, it has to be assumed that other countries model and adapt American policies and practices to meet their own country's specifications. If that was not the case, then other countries, like Canada, would not have also approved and licensed the same dangerous drugs. This has been seen with the drugs Vioxx, Prepulsid (called Propulsid in the US), Fen Phen, (links Here and Here), Baycol (links Here, Here and Here) and Seldane (the generic name is Terfenadine - Here, Here and Here), to name a few. And in the past, Health Canada has actually approved dangerous drugs that the FDA refused to approve, thalidomide is one example. A Canadian article published in the National Post explained that during the 10 years between 2005 and 2015, drug recalls in Canada have more than tripled.
In 2015, a New York Times article explained that recent FDA Commissioner, Dr. Robert Califf, inferred during a lecture that he gave that regulation actually hinders innovation. And, in a Los Angelos Times article, it explains how current FDA Commissioner, Dr. Scott Gottlieb, he wants to speed up the FDA drug approval process.
So presently, flawed FDA regulations helped produce the Vioxx catastrophe and those deficient regulations have not been changed to prevent future catastrophes. Furthermore, in the opinion of two FDA commissioners (who have recently led or are now leading this "broken" agency), the flawed regulations are now viewed as too time consuming and as a barrier to innovation. Based on that, it's reasonable to assume that any changes made within the FDA, under the leadership of these men, has likely been in the drug industry's favour. As Graham explained in both his testimony and interview, the FDA views industry as their client, and the FDA works to protect their client's interests.
MUST READ: 2 Page Interview with David Graham Here
MUST WATCH: Video of the Senate Hearing where David Graham and other doctors testified Here (introduction to David Graham begins at the 36:55 mark)
MUST READ (if you didn't watch the video): The transcript of Graham's full testimony given before Government, at the US Senate Committee on Finance hearing on Nov 18, 2004 Here
New York Times Article - Criminal Conviction and $950 Million Fine for Merck Here
Forbes - David Graham Face of the Year Here
Graham's 2005 research, on the Vioxx/heart attack link, published in the prestigous medical journal The Lancet Here
Prepulsid (called Propulsid in the US) was recalled in the US & Canada Here and Here
Fen Phen was recalled in the US and Canada Here and Here
Baycol was recalled in the US and Canada Here, Here and Here
Seldane was recalled in the US and Canada Here, Here and Here
Thalidomide was approved for us in Canada but not the US Here
National Post article: recalls in Canada have tripled in 10 years (2005-2015) Here
Dr. Robert Califf, a recent Commissioner of FDA, believes regulation hinders innovation Here
Dr. Robert Califf's FDA Bio is available Here
Dr. Scott Gottlieb, the current Commissioner of the FDA, believes in speeding up the drug approval process Here
Dr. Scott Gottlieb's FDA Bio is available Here
CONTINUE to the next article here: Safety & Efficacy 3
Content last updated July 18, 2018