Drug Safety: No one's Responsibility!
Shocking Story Reveals How the FDA Is Recklessly Abandoning Drug Safety
August 13 2012
By Dr. Mercola
In the wake of shocking reports on how the FDA, terrified of being outed for its questionable practices, spied on its own employees in the hopes of rooting them out before they could become whistleblowers, a new story has emerged on how deep the deceit goes. From marginalizing safety reports to not reading them at all―and then going ahead and approving the drugs in question―the FDA once more stands accused of being little more than a rubber-stamping agency for Big Pharma.Explosive revelations of an intensive spy operation by the FDA on its own scientists emerged last month. Using sophisticated spy software, the agency tracked and logged every move made by the targeted individuals. The program even intercepted personal emails and copied documents on their personal thumb drives.The targeted scientists had expressed concern over the agency’s approval of dangerous medical imaging devices for mammograms and colonoscopies, which they believe expose patients to dangerous levels of radiation. Now, another whistleblower has stepped forward, and what he has to say about the agency’s drug safety reviews is shocking even to the jaded...
Former FDA Reviewer Speaks Out About Systemic Suppression of Safety
Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for the online news magazine Truth-Out he tells Martha Rosenberg1:“In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee.There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug's approval - which of course was our job as drug reviewers - management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.”According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the medical safety reviewer completely failed to make such evaluations prior to the drug’s approval.
FDA Actively Thwarts Serious Safety Investigations
There’s no telling how many ineffective and/or dangerous drugs and medical devices have been approved and ushered into market through sheer intimidation and bullying, either by pharmaceutical companies or FDA management. Perhaps even more shocking are the revelations that some of the internal rules and regulations of the FDA are clearly designed to thwart serious safety reviews from the get-go.According to Kavanagh:“[H]uman clinical pharmacology trials are typically done in Europe, yet clinical pharmacology reviewers at FDA have been barred from analyzing this information prior to studies being conducted in the US. Without being able to do this, we are unable to detect evidence of risks early and cannot provide guidance that would help with the development of the drug in terms not only of safety and proving efficacy, but also with the efficiency and cost effectiveness of the drug's development.”Another loophole that can put your health in serious jeopardy is that drug companies are not required to include adverse events on the drug’s label if the adverse reaction is:
- Below a certain percentage, and/or
- Below double the rate of the adverse event found in a placeboAccording to Kavanagh:“By this rule, certain serious and potentially lethal adverse events that eventually resulted in a drug being withdrawn from the market would not have had any mention of the adverse events made in the labeling at all.”Kavanagh also claims to have discovered another common loophole used by pharmaceutical companies to circumvent safety issues. They’d simply submit bits and pieces of data to different places, effectively preventing the reviewer to pull it all together. Then, because the safety issues falsely appeared to be negligible, it would be decided that no further evaluation would be necessary...“On one occasion, the company even told me they were going to call upper management to get a clear requirement for approval that they did not want to fulfill eliminated, which I then saw happen. On another occasion a company clearly stated in a meeting that they had "paid for an approval,” Kavanagh says.“Sometimes we were literally instructed to only read a 100-150 page summary and to accept drug company claims without examining the actual data, which on multiple occasions I found directly contradicted the summary document. Other times I was ordered not to review certain sections of the submission, but invariably that's where the safety issues would be. This could only occur if FDA management was told about issues in the submission before it had even been reviewed.In addition, management would overload us with huge amounts of material that could not possibly be read by a given deadline and would withhold assistance. When you are able to dig in, if you found issues that would make you turn down a drug, you could be pressured to reverse your decision or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document.”
Examples of Dangerous Drug Approvals
In his interview, Kavanagh discusses some of the dangerous drugs that were approved in the face of unequivocal safety concerns. One is the nerve gas drug pyridostigmine—a prophylactic drug against the nerve agent Soman. The drug was approved under the "Animal Rule," which allows drugs to be approved based on animal data alone. There were multiple problems with this approval. First, the animal studies did not reflect how the drug would be used in humans. Second, the drug actually increases lethality if nerve agents otherthan Soman are used.According to Kavanagh:“This information was not secret - both FDA and DoD public documents acknowledge increased lethality with other nerve agents such as Sarin, and DoD and other government documents that are public also document that Saddam Hussein was not using Soman and was instead using these other nerve agents exclusively.Yet because I raised this as an objection, I was immediately replaced as the primary reviewer so that I could not document my concerns and so that pyridostigmine could be approved. It's since been proposed that if we ever face the prospect of nerve agents in the future, that this approval will be used as a justification to convince the President at that time to waive informed consent without presenting a full picture.”Pediatric drugs also end up posing unnecessary risks due to the FDA’s failure to adequately review safety risks, and the many scientific loopholes employed by pharmaceutical companies. For example, the following flawed parameters are typically used in pediatric drug studies:
- Dosages are based on approved adult dosages, without regard for metabolic differences between a developing child’s body and an adult
- Exposure studies oftentimes use overweight children, and include too few children to adequately evaluate risks
- No allowances are made for race, age, puberty, or actual weightDangers to pregnant women and their developing fetuses are also frequently ignored. All in all, the FDA appears to be engaged in a systematic hush-operation designed to give just about anything Big Pharma develops the green light. Essentially, dangerous drugs are given a rubber stamp of approval—the necessary go-ahead to make obscene profits while killing and injuring hundreds of thousands of people every year. It is, quite simply, inexcusable. The mainstream media has a lot to answer for as well, as their lack of reporting on these issues contributes to the problem by keeping a lid on reality.According to Kavanagh:“FDA's response to most expected risks is to deny them and wait until there is irrefutable evidence postmarketing, and then simply add a watered down warning in the labeling. In fact, when patients exhibit drug toxicity, it is usually attributed to an underlying condition which we know is likely to make the drug toxicity worse. This also allows the toxicity to be dismissed as being unrelated to the drug in any way.Consequently, toxicities are only attributed to the drug when the evidence is irrefutable. Thus the majority of cases where there is a contributing factor are simply dismissed. When you do raise potential safety issues, the refrain that I heard repeatedly from upper management was‚"where are the dead bodies in the street?" Which I took to mean that we only do something if the press is making an issue of it.”
FDA Safety Reviewers Made to Fear for Their Lives?
Kavanagh was not surprised to learn about the agency’s retaliation against the five whistleblowers, giving several examples of how he was personally intimidated, to the point of fearing for his life, and the safety of his children!“After FDA management learned I had gone to Congress about certain issues, I found my office had been entered and my computer physically tampered with,” Kavanagh tells Rosenberg.“... After I gave Representative Waxman's (D-CA) office a USB drive with evidence, FDA staff was admonished that it was prohibited to download information to USB drives. Then, after I openly reported irregularities in an antipsychotic drug review and FDA financial collusion with outsiders to Senator Grassley’s office and the House Committee on Oversight and Government Reform, I was threatened with prison if I should release trade secret information to Congress... [T]he Food Drug and Cosmetics Act explicitly allows communication of trade secrets by FDA employees to Congress, but since most people are unaware of this, FDA management can use the threat of jail for violation of the Trade Secrets Act, not only to discourage reviewers, but in my case they got Senator Grassley's staff to destroy the evidence I provided them.The threats, however, can be much worse than prison. One manager threatened my children - who had just turned 4 and 7 years old - and in one large staff meeting, I was referred to as a "saboteur." Based on other things that happened and were said, I was afraid that I could be killed for talking to Congress and criminal investigators.”
We Now Know What Domestic Surveillance of Whistleblowers Looks Like
The following video features attorney, Stephen Kohn, executive director of the National Whistleblowers Center and attorney for the FDA whistleblowers in the recently revealed FDA spy operation against them2."For the first time, we now have a glimpse into what domestic surveillance of whistleblowers looks like in this country with the modern technological developments," Kohn says. "The agency [sought] to destroy the reputation of these whistleblowers forever."
FDA Failures Place Health of Americans and Nation at Grave Risk
The FDA’s mission statement reads as follows:“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”In 2007, a report bearing the revealing title “FDA Science and Mission at Risk” by the Subcommittee on Science and Technology3, detailed how the FDA cannot fulfill its stated mission because:
- Its scientific base has eroded and its scientific organizational structure is weak
- Its scientific workforce does not have sufficient capacity and capability, and
- Its information technology (IT) infrastructure is inadequateFurthermore, the report found that “the development of medical products based on “new science” cannot be adequately regulated by the FDA, and that the agency does not have the capacity to carry out risk assessment and analysis. Additionally, the agency’s science agenda “lacks coherent structure and vision, as well as effective coordination and prioritization.”The fact that the FDA does not have its ducks in a row; has sorely misplaced its priorities; and is not working to fulfill its mission is clearly evidenced in the numerous cases where hundreds and sometimes thousands of complaints about dangerous drugs (like Vioxx and Avandia), vaccines (like Gardasil), and additives (like aspartame) are stubbornly ignored, while SWAT-style teams armed to the teeth are sent to raid supplement makers, whole food businesses, organic farmers, and raw dairies when oftentimes not a single incidence of harm can be attributed to their products.According to the Science and Technology Subcommittee’s report, the failures of the FDA is placing the health of Americans, and indeed the economic health of the entire nation, at grave risk:“The FDA constitutes a critical component of our nation’s healthcare delivery and public health system. The FDA, as much as any public or private sector institution in this country, touches the lives, health and wellbeing of all Americans and is integral to the nation’s economy and its security.The FDA’s responsibilities for protecting the health of Americans are far-reaching. The FDA protects our nation’s food supply through regulatory activities designed to cover 80 percent of the food consumed in this country. The FDA also regulates all drugs, human vaccines, and medical devices, and hence plays a critical role in ensuring the appropriate safety and efficacy of rapidly emerging medical products.... The FDA is also central to the economic health of the nation, regulating approximately $1 trillion in consumer products or 25 cents of every consumer dollar expended in this country annually.. Thus, the nation is at risk if FDA science is at risk. The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”
One of the root causes for their utter abandonment of public safety is that the majority of the FDA’s funding comes from the very companies that it is seeking to monitor and evaluate. The FDA has progressively morphed into a mere pawn and instrument of the drug industry, which has little to do with drug safety, and everything to do with maximizing profits.As Dr. David Graham—another prominent FDA whistleblower who blew the lid on the Vioxx scandal—stated in a 2005 interview:“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.Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towards the approval of new drugs and 20 percent is for everything else. Drug safety is about 5 percent. The "gorilla in the living room" is new drugs and approval. Congress has not only created that structure, they have also worsened that structure through the PDUFA, the Prescription Drug User Fee Act, by which drug companies pay money to the FDA so they will review and approve its drug.”The only real solution isn't minor changes to the existing structure, but a complete reform of the FDA. But until then, please, don't risk your money or your life on a paradigm designed to profit from your ill health. Instead, switch to natural methods that will allow your body to heal itself without the need for the deadly drugs being pushed on you by the drug companies and the FDA.