Struggling with acne?
If you’re struggling with acne, don’t worry. After a round of Accutane no one will probably notice because, er, they’ll be looking at the hair growing on the side of your nose. Worried about your cholesterol levels? Take some Lipitor and forget about it. No, ACTUALLY forget about it. As in, develop full-blown amnesia.Oh, and if you know anyone that wants to reverse male pattern baldness Propecia can help . . . as long as they don’t mind growing fully functional, lactating breasts, that is.
Is it just me, or does it give you pause that these medications have been FDA approved as “safe and effective”? While usually rare, unintended side effects are very real to the families whose lives they touch. Get ready for a hard left turn, y’all, because today’s post is not just about irony or bizarre side effects. I shared these examples so that we can all be reminded that “safe and effective” doesn’t always mean what we would like it to, and to present some info I think every person should have as we head into flu season.
[Warning: I found much of this information to be very difficult to write about, but I believe it is worth sharing. If you are not considering taking Tamiflu or giving it to a family member you may want to skip this post]
Tamiflu Banned In Japan After Suicides
Tamiflu – which is marketed as a drug that can reduce the symptoms and life cycle of the flu (by about one day) – was banned in Japan after twelve children died while taking it.
In 2005, a 14-year old girl either fell or jumped to her death from a high-rise apartment building after taking the medication, while “a 17-year-old boy who had taken Tamiflu before going to bed . . . walked out of the house and stood in front of an oncoming truck. The truck driver told police the boy was smiling at the moment of impact.” (source 1, source 2)
Reports also include “an incident in which a 14-year-old boy with flu took a single dose of Tamiflu and two hours later fell from the ninth floor of his apartment building. Another involved a child who, hours after taking a second dose, jumped from the second floor of his house into deep snow. He was unhurt and later remembered jumping, but didn’t know why.” (source) Three adults in Japan also committed suicide while on the medication. (source)
Around that time, FDA spokeswoman Susan Bro told the Associated Press that the FDA had received the information on the deaths from Roche and the Japanese Ministry of Health, “Our scientists have said, even with the additional information, we are not seeing any reason to make a causal association between the use of the drug and the deaths,” she said. “The data don’t lead to that conclusion.” Japan, which closely monitors all new drugs brought to market, acted by banning Tamiflu for use in 10-19 year olds in 2007.
So what data gave the FDA such confidence, you may ask? Over six years later just about everyone is wondering the same thing. You see, Tamiflu maker Roche has never released 60% of the the details of their Phase III trials. You know, the ones that supposedly prove their drug is “safe and effective.” (source 1, source 2, source 3)
But SURELY even if there are risks, the benefits outweigh them, right? Riiiiiiight. I mean, why would a drug manufacturer sell a drug that was dangerous or didn’t work, then ignore widespread evidence when it surfaced?
Prestigious British Medical Journal Calls Tamiflu Maker Out
In 2009, after nations around the world spent billions of dollars stockpiling Tamiflu for a potential pandemic,
“the National Health Service in Great Britain commissioned the Cochrane Collaboration (an international network of researchers) to review and update the evidence on the use of this class of medications. Initially, no one involved believed that the 2009 systematic review would yield any new insights. They were wrong.
The Cochrane researchers found that the 2003 study relied mostly on unpublished data supplied by Roche [Tamiflu’s manufacturer]. After multiple attempts to get access to the data, researchers ran their analysis with the data they had available. They found no evidence to support claims that Tamiflu prevented the spread of, or complications from, influenza.” (source, emphasis mine)
After the review, the prestigious British Medical Journal began a very public campaign to try to get Roche to release the data from their clinical trials. According to them:
- WHO recommends Tamiflu, but has not vetted the Tamiflu data.
- EMA approved Tamiflu, but did not review the full Tamiflu dataset.
- CDC and ECDC encourage the use and stockpiling of Tamiflu, but did not vet the Tamiflu data.
- The majority of Roche’s Phase III treatment trials remain unpublished over a decade after completion.
- In Dec 2009, Roche publicly promised independent scientists access to “full study reports” for selected Tamiflu trials, but to date the company has not made even one full report available.
Um, yeah, did you catch that? It gets even better: the most common side effects of this particular drug are nausea, diarrhea, and vomiting. Only slightly less common are headache, dizziness, fatigue and cough! So in exchange for taking a potentially dangerous drug that is considered ineffective by BMJ, you get more flu symptoms. Awesome. (source)
At least one BMJ researcher involved in the analysis has called for world governments to sue to get their money back on what may be a virtually worthless drug.
Tamiflu Manufacturer Under Investigation
Tamiflu’s manufacturer, Roche, is accused of underreporting side effects on other drugs as well. “Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs . . . that were used in about 80,000 patients in the U.S.,” says a U.K. news source.
Among those drugs I’m betting they’re looking at Lariam – an anti-malaria medication commonly prescribed to tourists and soldiers that has been implicated in several psychotic episodes and homicides.
“Roche, the drug company, claims that Lariam causes serious psychiatric side effects in only one in 10,000 people. But Dr. Paul Clarke, an infectious disease specialist and the medical director of a large network of travel clinics in Great Britain, organized his own study, after he and other British doctors saw problems with much greater frequency.
‘It was confusion, it was disorientation, it was anxiety and panic attacks,’ says Clarke. ‘There were episodes in which people were clearly divorced from reality and indeed had unusual symptoms that could be described as psychotic.’
Their research confirmed the hunch. Not one in 10,000, but closer to one in a 140 suffered disabling side effects, defined as substantially disrupting their lives – the same kinds of side effects that Dr. Clarke had seen in his patients. ” (source, emphasis mine)
Is Tamiflu Really To Blame?
The FDA has suggested that the psychiatric events and deaths reported in Japan could have stemmed from a fever-induced delirium or other medications that the patient may have been taking. However, Rokuro Hama, MD, a Japanese researcher who collaborated on the Cochrane review of Tamiflu, disagrees.
“Pediatric specialists say that fever or various drugs may cause delirium and only little scientific evidence exists about causal relation between Tamiflu and the events. These comments are not correct, because there are several cases in which the patients had no fever (after temperature went down to almost normal or even lower) or took no medicine other than Tamiflu,” he says.
According to Dr. Hama, “Normally, Tamiflu cannot penetrate the [blood brain] barrier. But it becomes more permeable when the tissue is inflamed, as can happen in flu. Japanese doctors fear that Tamiflu might be getting into the brain, depressing activity and ‘disinhibiting’ some behaviours.”
In addition, a research team led by Osaka City University Professor Yoshio Hirota found that “patients ages 10 to 17 who took Tamiflu had a 54 percent greater chance of exhibiting abnormal behavior than those patients who did not take the medication. . . . The report identified examples of abnormal behavior as a child who attempted to leap from a balcony or a child who began hopping after consuming Tamiflu. No margin of error was given for the medical study.” (source)
The Bottom Line
Just this year Roche promised yet again to release their Phase III trial data with some info redacted to “protect confidentiality and legitimate commercial interests.” (source) When finally delivered the report may have enough holes to be mistaken for swiss cheese, but we’ll see.
In the meantime, the FDA has approved Tamiflu for use in infants and young children despite documentation that it can induce terrifying nightmares and cause children to hear voices (source 1, source 2, source 3, source 4, source 5) One mother reported that her six-year old daughter asked for help after taking Tamiflu and hearing voices that said “Give me all your money or I’ll shoot you.” (source)