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Tuesday, December 25, 2012

Gastric Bypass Surgery Death Rate

Gastric bypass surgery, the drastic procedure used to help some obese people lose weight, continues to grow in popularity. 

It's estimated that 140,000 people had this procedure in 2004, with the number expected to grow even higher this year. And for the majority of patients, this surgery is a lifesaver, but not for all, reports The Early Show correspondent Melinda Murphys. 

Like many people who seek out this surgery, Dave Weindel had been morbidly obese for most of his life. So he was eager to have surgery to help him lose weight, get healthy, and live longer to watch his four young children grow. 

"I graduated from eighth grade a couple years later," Christy Weindel says, crying. "And he wasn't there for that. And he wasn't there for prom. And I just got married in September. And he wasn't there for that. It's really tough.

Christy Weindel lost her father when she was 12 years old. Dave Weindel died three weeks after having gastric bypass surgery. 

"I had to come home and had to tell the kids that their dad died. Was very, very hard," says, Cathy Weindel. According to Weindel's wife, it wasn't supposed to turn out this way. 

She says, "Well, they told us it was major surgery. But they said, 'You know, you're going to be home in three days.' "

Weindel's surgery was July 17, 1998. His stomach was reduced to the size of an egg and his intestines were re-routed. The surgeon told Cathy Weindel the operation went well. But within days, Weindel's health worsened. 

He was transferred to a second hospital, where a CT scan revealed a large abscess. Weindel was treated, but his health continued to decline. 

Cathy Weindel says she thinks her husband knew what was happening to him. 

"I still remember, and I still see this in my mind," she says very emotionally. "When they're shutting everything down and there was nothing else they could do. I was talking to him. And I saw a tear come out of his eye. And, I mean, it still stays with me."

Dave Weindel died three weeks after his surgery. He was 38. The official cause of death: abscess, pneumonia and a pulmonary embolism.

Was Dave Weindel's case a complete anomaly? Not really. 

A recent study by researchers at the University of Washington found that 1 in 50 people die within one month of having gastric bypass surgery, and that figure jumps nearly fivefold if the surgeon is inexperienced. 

Attorney Herman Praszkier says, "You want to know, basically, as much information about the surgeon's background as you can. Anyone who evades your question, get up and walk out."

Praszkier represented Cathy Weindel in her lawsuit against her husband's surgeon and the hospital. It was settled days into the trial and was the first of a dozen gastric bypass malpractice cases he's handled.

Praszkier explains, "The most common problem in bariatric surgery in the cases I take (which are only death cases) is that the post-operative care was insufficient." 

Nora Malone is Praszkier's most recent client. She tried to talk her husband, Ron, out of the surgery.

"I said, 'Let's go. Let's just go.' And he said, 'Oh, I'll be OK, honey. You'll be so proud of me when I get out of here,' " Malone recalls.

Nora Malone met her husband when he was a naval officer stationed in the Philippines in 1973. They had three daughters. 

Their daughter. Liberty. says, "When they went to talk to the doctors, they came back thinking it was a good thing. You know, he'd get off his high blood pressure medicine, his diabetes medicine." 

Malone had laparascopic gastric bypass surgery just before Thanksgiving 2003. 

"They said there's no risk," Nora Malone says.

But days after the surgery, Ron Malone became very ill. Doctors told his family there was a leak - and operated again. He didn't improve. 

Nora Malone recalls, "And I said, 'I think you have to do something, doctor.' And he said, 'Mrs. Malone, trust me, your husband is OK.' " 

On Dec. 9, 2003, Ron Malone died during his third surgery. The official cause of death: cardiac arrest. More accurately, Malone died from complications of gastric bypass surgery.

Dr. Harvey Sugerman says, "There is a risk of a leak following gastric bypass that can be fatal." 

Dr. Sugerman is a retired bariatric surgeon and the president of the American Society for Bariatric Surgery (ASBS). He says early diagnosis of a problem is the key.

"I think some doctors got into it without adequate training and experience and felt that they could do this," Dr. Sugerman says, "The ASBS is very concerned about deaths after obesity surgery. And we are doing everything we can to improve quality care by establishing the Center of Excellence program." 

This program will have stringent guidelines that must be met in order for a bariatric surgery facility to be called, "a Center of Excellence." When the program launches in June, information will be posted on a Web site to help patients find quality doctors and hospitals. Unfortunately, it comes too late for Ron Malone.

And too late for Dave Weindel, whose wife no longer believes in the surgery. 

"I don't think it's worth it," Cathy Weindel says "It tears your family apart."

CLICK here to watch gastric bypass video 

Still not convinced? 

More on the Actual Gastric Bypass Death Rate

A helpful blog reader send me the full PDF version of the study of the long term outcome of weight loss surgery in Pennsylvania which was cited in the previous blog post.

Death Rates and Causes of Death after Bariatric Surgery for Pennsylvania Residents 1994-2004. Bennet I. Omalu et. al. Arch Surg. 2007;142(10):923-928.

Typically when a surgeon tells you the mortality rate for a surgery, he tells you only the percentage of those who died within 30 days of the surgery. This study looked both at the actual deaths within 30 days after surgery and in the death rate in the years after the surgery.

As the study reports, in the 16,683 people who had weight loss surgery in Pennsylvania between 1994 and 2004, .9% died within 30 days of the surgery. That translated into 150 people.

But wait. That statistic was taken from the group as a whole. When the population is broken out by age, a much scarier statistic emerges: In the age group 55-64 1.53% were dead within 30 days, or 15 out of 1000 who had the surgery. And for the age group of those 65 and older, 3.1% died within 30 days, or 3 out of every hundred.

But that was just in the first 30 days after surgery. The study looked at time since surgery, and with each passing year the number of dead grew greater.

By one year after surgery, 2.1% of the group had died. (Twenty-one out of every thousand.) By two years, 2.9%. Then things got worse. Three years after they had had the surgery, 3.7% were dead. By four years, 4.8% and by five years, 6.4%.

The authors of this study remark that they did not follow up on the results of subsequent surgeries. But other studies have found that many people who have weight loss surgery require one or more follow up surgeries in the years that follow the initial surgery. It is likely that each subsequent surgery raises the risk of further complications and death.

Another chilling statistic emerged from the analysis of this data. In a population of the same size of the same demographic make up, the expected number of suicides would be 2. However, in this group, there were 16 suicides and an additional 14 drug overdose deaths. Most of these occurred at least one year after the surgery. The authors of the study speculate that many of the drug overdoses were probably suicides too, and flag this as a serious problem that requires more study.

What was missing in this study was one important piece of information: the weight loss achieved by the people who died. The authors assume that the high death rate is due to health conditions contracted while obese or due to weight regain. But this is only speculation. They did not review any statistics about the size of the people at death, which would have been difficult to do since only about 1/3 of these victims were autopsied.

But based on stories I have heard and cases like Mrs. Yamin's it may be premature to assume that the deaths were caused by obesity. Mrs. Yamin weighed 100 lbs at her death. Instead deaths may have been caused by long term malnutrition--i.e. starvation. Though the most common cause of death listed on death certificates after a year was cardiovascular (i.e. heart attacks) that is what kills a lot of people with anorexia and starvation. When the body is no longer absorbing nutrients the electrolytes can become dangerously unbalanced and that causes heart attack. Without independent autopsies, it is very hard to know what really happened.

Doctors don't like autopsies, because a patient who didn't have an autopsy is a patient whose family is going to have a much tougher time suing for malpractice. So if a heart stops beating, well, write it down as cardiovascular death, and since the person was once fat, who is going to challenge it?

But folks, please take these statistics seriously. And please note that the things that killed people within the first 30 days were NOT necessarily caused by obesity. Among the biggest killers were pulmonary embolism (20.7% of all early deaths)and sepsis (i.e. infection that spread through the body causing organ shut down). Sepsis killed 11.3% of those who died in the first 30 days. One out of four died of vaguely specified "therapeutic complications" which is a catchall term entered on the death certificate that included things like sepsis, bleeding, ruptured surgical wounds, etc.

One last word. Many people erroneously believe that before a doctor can perform a specific kind of surgery, that surgery must undergo the same kind of safety testing and approval process that drugs get. This is not true. Surgeons can perform any surgery they want, as long as they are licensed surgeons.

There is only one limitation on what kind of surgeries are performed: whether or not insurance companies will pay for them. Most insurers won't pay for operations that have a poor safety record--once they have enough data to know that the operation isn't safe.

But weight loss surgery is usually NOT paid for by insurers. Like plastic surgery, it is a surgery that patients pay for out of their own funds. This is one reason surgeons promote it so strongly. There are no forms for them to to fill out, no limit on what they can charge, and most importantly, no evaluating the patient's suitability for the surgery by pesky insurance review boards. All the doctor has to do is sell the patient on the operation, and the fun can begin.

So don't let yourself become a victim of a surgeon who has found a dandy way to make himself a multi-millionaire. And don't trust that the doctor who stands to make $25,000 for a few hours of work has your welfare in mind when he assures you that a surgery is no more dangerous than crossing the street. Remember, surgeons rarely track the outcome of their surgeries beyond six weeks. But as the Pennsylvania study suggests weight loss surgery keeps on killing for years after the initial surgery.

Sunday, December 2, 2012

Depression and Suicide After Gastric Bypass

For some reason or reasons there are high suicide rates after gastric bypass. Nobody seems to know why but there has been some speculation as to why gastric bypass victims become depressed and kill themselves.  I will speculate and toss out some of my thought.

Some assholes have suggested that it is because of some identity crisis that has to do with a fat person living in a skinny body. That's bullshit. There are not fat people or skinny people. There are fat bodied people and lean bodied people. Most people don't want to be fat same as people with disfigured faces or unattractive in some other physical way. Usually when they remedy that problem they become happier.

Other assholes have suggested that the reason people are fat is because of some psychological condition that made them over eat.  This assertion is pure conjecture.  In fact the scientific evidence suggests that fat bodied men are psychologically more stable than their leaner counterparts, (Fat men really are jolly) and fat women are no more or no less mentally ill than their thin counter parts. They are just nuts in different ways.

My guess is that the trauma of the surgery can trigger depression along with the combination of anesthesia  and pain medication.  A more reasonable theory is a nutritional one. Gastric bypass work by two method, restriction and mal-absorption. Gastric bypass victims have to radically change their diets in order to prevent vomiting and dumping syndrome. Restriction and mal-absorption causes malnutrition. Malnutrition causes mental illness.  The victim can still maintain weight but they cannot maintain weight by eating nutritional food.  The are stuck eating protein drinks and high fat foods. Carbs cause dumping syndrome so victims avoid them. When that happen their livers become depleted of glycogen which is the storage form of glucose. Cells in the body can function on glucose which is their preferred fuel source but they can also function on ketones. Brain cells can only function on glucose.  Prolonged carb restriction causes ketogenic psychosis. That is probably why the suicide rate is so high with gastric bypass victims. 

If you or someone you know suffers from depression chances are some lowlife scumbag doctor will put you on some anti depression drug.  The following article by Dr Mercola explains the dangers of anti depressants.

Related: Dr Oz Busted Click HERE

By Dr. Mercola
Pharmaceutical companies have kept the wool pulled over Americans' eyes for many years, and had many convinced that they were working fervently to develop safe medications that would cure and prevent virtually every disease plaguing the world.
But these modern-day messiahs are not the saints they would have you believe … not even close.
According to Dr. David Healy, who has had the opportunity to investigate the circumstances behind the approval of certain drugs at a level that very few others have been able to, drug companies frequently hide vital information about their drugs in order to get it on the market and keep it there.
The drug companies that manufacture some of the best-selling drugs in the world have committed some of the greatest crimes against human health, and all of them have at one point or another been found guilty of criminal activity—some have been nailed several times.
So much so that several pharmaceutical companies are on the Top Corporate Criminals list. Yet we entrust our health, our very lives, to these same corporate "personages" who cannot be put in jail for cutting lives short, and who view billion dollar fines as nothing more than the cost of doing business.
As recently as July 2, GlaxoSmithKline plead guilty to three counts of criminal misdemeanor and other civil liabilities relating to the prescription drugs Paxil, Wellbutrin and Avandia, and agreed to pay a total of $3 billion in fines.
In 2009 Pfizer was fined $2.3 billion to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs, including the painkiller Bextra and their antipsychotic drug Geodon.
Dr. Healy, a professor of psychiatry in North Wales and Great Britain is a former secretary of the British Association for Psychopharmacology and author of over 175 peer-reviewed articles, 200 other pieces, and 20 books, including Let Them Eat Prozac (one of my favorites), and Pharmageddon, another favorite.
His time is divided between an active psychiatry practice and research.
For example, he has studied the serotonin-uptake theory in depressed patients, and is adamant that there's no evidence indicating that depressed patients have something wrong with their serotonin system, which makes selective serotonin reuptake inhibitors (SSRI's) a dubious treatment for depression. It may even be part of the equation for why some people become suicidal on SSRI's, even if they've never had such tendencies before.
"We've got 30 to 40 years' worth of work, and no evidence has come to light that there's anything wrong with the serotonin system in people who were depressed," he says.

Profits Before Life—The Sad History of Antidepressant Drugs

Dr. Healy's conviction that SSRI's can make people actively suicidal was originally borne directly out of his own clinical experience. Since then, the research demonstrating this link has become quite clear, and this class of drugs now carry a "black box" warning. What's really infuriating though is the evidence that has since emerged showing that pharmaceutical companies knew about it, and hid it, and it wasn't until it became an obvious issue in clinical practice that a warning was finally issued. People literally lost their lives because these companies didn't want to risk sluggish sales.
"I got involved as an expert witness in some legal cases that involved these drugs," Dr. Healy explains. "When you get involved as an expert witness in legal cases, you get to go behind the scenes. You get to go into the company archives, and you get to see what the clinical trials really showed, and what the company personnel really thought about the issues.
Then it was clear that the trials also really showed those problems. It was clear that the companies knew there was a problem, and they were in the business of trying to hush the whole thing up.
... The regulators also clearly knew there was a problem, I would say from very early on. They may well have known there was a problem even before the drugs came to the market. They certainly knew there was a problem shortly after Prozac was launched and a great number of people complained about the fact that they had a problem on this drug.
When they looked at the data – the kinds of data that the FDA, for instance, would have been able to see when they held the first public meeting about whether SSRI drugs, Prozac in particular, could cause people to become suicidal – they had a lot of data that the rest of us didn't have. They had data on the other SSRIs that haven't yet been marketed.... I'm sure it was very clear to them then that the SSRIs can cause people to become suicidal."
Publicly, the FDA argued that putting  a warning on the drug might deter people from treatment, so by doing the right thing, we might end up with a detrimental outcome. However, no one addressed the fact that not putting a warning on the drug might make more people use them, hence killing more people, more indiscriminately. This is exactly the situation we're dealing with now. Even with the warning, antidepressants are prescribed more or less willy-nilly, for everything from anxiety to pain, high blood pressure, and insomnia—minor ailments that in NO WAY warrant such a huge risk.
"[The information] the FDA had points very clearly not just to the fact that [SSRI] drugs can cause a problem, but that on balance, they harm more people than they help," Dr. Healy says. "How the FDA squared this, I'm not sure."

SSRI's Likely Harm More People than They Help

In addition to suicidal thoughts and behavior, there also seems to be an association between antidepressants and other violent behaviors, such as homicides and school shootings. Unfortunately, while suicide has become a well-established (yet oft-ignored) side effect, the data on other types of violence is, again, being hidden.
"We haven't had hearings about this issue," Dr. Healy says. "People haven't had access to the data. There's been no publications around it. This is one of the biggest problems on which there's a huge amount of data, but to which we've got little or no access."
Dr. Healy estimates that possibly 1,000 to 2,000 people taking an SSRI drug commits suicide each year in the US who would not have done so were they not on the drug. He also believes there's a comparable number of people who will commit a violent act against others as a result of the drug, who would not have done so otherwise. Then there's the issue of generational harm. Birth defects, miscarriages (as many as 20,000 per year), and voluntary abortions due to the baby being diagnosed with a birth defect are other devastating side effects that get little if any attention.
Why is that?
Why is so little attention given to the very serious nature of the side effects associated with these drugs? Why are antidepressants seemingly handed out like candy to cheer people up, as opposed to treat serious mental conditions?
A major part of the problem is the too-cozy-for-comfort relationship between drug companies and psychiatrists and other prescribers. Adding to that problem is the fact that drug companies are actively hiding and suppressing negative data on their drugs, so psychiatrists prescribe drugs without having the real facts.

Psychiatry is Committing "Professional Suicide"

Dr. Healy was recently featured in Time Magazine1, after giving a speech at the American Psychiatric Association's (APA) second largest annual meeting. The topic of the session was conflicts of interest in psychiatry. Maia Szalavitz writes:
"Arguing that his profession is "committing professional suicide" by failing to address its dangerously close relationship with the pharmaceutical industry, he likened psychiatry's attitude toward its faltering legitimacy to the Vatican's widely derided response to its child-sex-abuse scandal by priests — essentially that psychiatry is brushing off justifiable concerns as hype instead of dealing with the source of the problem.
Few experts believe that psychiatry's relationship with the drug industry is healthy. While several speakers at the session pointed out that other specialties are similarly entangled with industry, "everyone does it" is generally not a valid defense where conflicts of interest are concerned.
... "I'm going to argue that we need you to be biased. We want you to be biased by treatments that work," Healy told his colleagues. "I don't mind if you're my doctor and you've given talks for industry. My concern is not that you've been paid by industry, but that you've been fooled by industry. The key conflict is whether people are hiding data from you."
The article goes on to detail some the more unsavory aspects of conflicts of interest—the kind of suppression activities that lead to demolished careers, and worse. Dr. Healy has been personally targeted by drug companies for speaking out against various drugs and exposing wrongdoing. His presentation at the APA included a document obtained via a Freedom of Information Act request, which reveals Eli Lilly's plan for countering his public discourses on how drug companies hide drug data. One of these strategies includes planting people in the audience of his presentations to argue the industry's view.

What Clinical Trials Do and Do Not Show

According to Dr. Healy, in the clinical trials done to bring antidepressants to market it is virtually impossible to show that they have an overall positive effect. Part of the problem that few consider is the fact that clinical trials are not designed to answer some of the most important questions we have about any given drug, such as: Does this drug save lives?
"From what we know of the data that's there, the answer is no, they [antidepressants] don't save lives," Dr. Healy says. "Clinical trials also aren't designed to answer the question, "Will these drugs get people back to work?" From the data we have, we have no reason to think that these drugs will be more likely to get people back to work than placebo would, for instance.
In terms of what most people understand the word "work" to really mean, which is [in the vein of the questions] "Will my life be saved?" or "Will I be able to get back to being employed?" we have no evidence that these drugs "work."  What we've got is clinical trials based on rating scales, where you can show that the drug does marginally better than placebo on these rating scales. But that's all we have."
Fortunately, there are other alternatives, which have been shown to have a more life-enhancing effect than antidepressants, such as niacin (vitamin B3). The renowned and recently deceased Canadian psychiatrist Dr. Abram Hoffer was a strong advocate of the use of niacin in psychiatric illness, specifically for schizophrenia, for which there don't seem to be many really good treatments.
What he discovered was that niacin deficiency is a major contributor to pellagra, the symptoms of which mimic depression.
He believed there's a subgroup of people who have an increased nutritional requirement for niacin, making them not merely deficient per se, but niacin dependent. When they don't get it on a regular basis, and typically in far higher doses than normal, they're predisposed to psychiatric illnesses. Dr. Healy believes there may be significant value in niacin supplementation, adding that one of the mechanisms of niacin is detoxification, especially lead. This makes sense, since it it's a potent vasodilator, which would increase supply to the filtering organs, thereby aiding in the excretion process.
To view the full interview, please click HERE!

What's the Mechanism of SSRI's that Make Them so Pernicious?

According to Dr. Healy, the mechanism of harm has not been clearly established. The most likely mechanism of harm is the fact that they act on your serotonin system.
"Serotonin is the most primitive neurotransmitter there is. Even in a single-celled creature, it's there. When you're acting on it, you're acting on a mechanism that is very primitive and very, very profound," Dr. Healy says. "So, it may be just purely the action on your serotonin system that is the problem.
Now, people who say, "I know SSRIs work" are doing the same kind of thing as saying "I know red wine works." If you have a nice glass of red wine in the evening, you feel mellowed out and chilled out... The SSRIs can work in the same kind of way, and can do a useful thing, which is: chill people out. You can get people who were stressed from work who are now a little less stressed at work because of the SSRI they're on. In that sense, they can clearly work—not for all people, but for a portion of people.
But when you test them out in groups of people who are clinically depressed (just as we would find if we were to test alcohol out in groups of people who are clinically depressed in six- to eight-week trials) it's actually rather hard to show that they do any better than placebo. They have, in fact, much the same rates of improvement compared to placebo, as we would expect to find if the drug we were actually testing was alcohol rather than Prozac, for instance."
... What you've got in the case of the SSRIs is much more like a psychic aspirin.
They numb you slightly. They take the emotional pain away. But they do this only when your serotonin system's working normally. And they make your serotonin system more abnormal after you've been on a course of treatment than it was to begin with."

Do Prescription Drugs Save Lives?

In his book Pharmageddon, Dr. Healy expands on the skewed data and other manipulation techniques employed in drug trials. While we spend a great deal of time discussing antidepressants in this interview (which you can listen to in its entirety by following the hyperlink provided above), the situation in terms of proving benefit is the same for other drugs.
Statins, for example, can indeed lower your cholesterol levels, and many do so quite well. So in that sense, they "work." But as with antidepressants, if you ask the question "Do these drugs save lives?" the answer becomes rather murky.
"If you ask the question "Are people going to be better able to work on these drugs?" then the answer is clear: They're actually going to be LESS able to go to work," Dr. Healy says. "They're going to have a range of problems and other symptoms that they didn't have off the pills.
Now, if you got marginally raised lipid levels, that is not something that interferes with your capacity to work. But if you're on a drug like one of the statins for instance, you are on a drug that may cause muscle aches, pains, cognitive failures, and may seriously interfere with your capacity to work."
Osteoporosis drugs are another good example of drugs that, overall, do more harm than good.
"They say up to a third of women over the age of 50 have osteoporosis," Dr. Healy says. "But they don't. This is an osteoporosis that's created by the DEXA scanners that the pharmaceutical companies gave away for free when they were marketing drugs for osteoporosis. If you scan bones, you'll almost always find little bits of thinning here and thinning there.
So you can create the diagnosis of osteoporosis, and you put these women on pills. Because they're on pills, they think their bones are brittle, so they'll probably do the wrong thing, which is they'll think they shouldn't go out and mow the lawn. They shouldn't jog... because their bones are brittle and they might have a fracture. But in fact, getting out to mow the lawn, jog, and get physically fit is a much better thing for them to be doing than to be taking osteoporosis pills, unless they've got very severe osteoporosis."
Personally, I don't see a reason for ever using an osteoporosis drug. They're extremely poisonous, and they kill your osteoclasts, the cells responsible for destroying old damaged and unnecessary bone cells that set your osteoblasts up to replace it with new bone tissue. This creates a dynamic balance of bone resorption and bone building. They make your bone denser, but at the same time they make them weaker. 

Why You Don't Want a Doctor Who Follows All the Latest Guidelines

The sad truth is, there's no easy way to determine what you can trust when it comes to medical research and official treatment guidelines. So much of it has been tainted by economic conflicts of interests. An important point made by Dr. Healy is that a doctor who strictly keeps to the guidelines is going to be far more controlled by the pharmaceutical industry than might be good for your health...
"We're in a world where you want a doctor who, for the sake of giving you good care, is prepared to take the risk of losing their job, because this is the world that good doctors increasingly are being forced into. They're being forced into being the kind of physician that says, "I know the guidelines are wrong. Yes, they based it on the latest evidence. But the industry actually controls the evidence, and as far as they do, they control the guidelines process also. I'm going to go by what seems to be the best thing for me to do for my patients." 
Unfortunately, there's no simple way to pick out articles in the literature and say, "We can believe this and not that." In fact, you could almost say that the articles in what we used to think of as the best journals in the field – like the New England Journal of Medicine, JAMA, and other journals like this – are more likely to be compromised than articles in perhaps journals that are less well-known."
A perfect example of this is the article I recently did on a study that was widely promoted in the media, which declared that eggs were associated with as much risk for strokes as smoking. It was a critically flawed study. And when we looked at the funding of the study, we discovered strong ties to the pharmaceutical industry. Two of the three researchers in question, have declared interests in statins. Now do you think the companies that make statins might have a vested interest in getting you to be afraid of eggs and cholesterol? Of course they do. The third researcher helped create the vegan "Portfolio Diet," which only allows egg substitutes and then only sparingly, so he too has a financial stake in scaring people away from eggs.

How Outsourcing Clinical Trials Can Skew or Hide Unsavory Findings

Another significant problem that most people don't have a clue about is how outsourcing clinical trials to other countries can affect their believability. Even trials done in the US have been plagued with fraud, such as enlisting patients that don't actually exist. The matter of potential fraud increases with overseas trials, because the FDA does not have the ability to double-check the veracity of the data even if they wanted to (and even in US trials they rarely do).
"There's a trial recently that brought Abilify® to the market with an indication for maintenance treatment for bipolar disorder. This trial was run in approximately 30 U.S. clinical trial centers and two further clinical trial centers in Mexico. In the trial centers based in the United States, when you added all the patients together, you found that Abilify® didn't do any good.
It couldn't beat placebo as a maintenance treatment for patients who had bipolar disorder.
In the Mexican centers, however, it really did beat placebo. It wonderfully beat it. All of the patients down there who got Abilify® did well, and the patients who got placebo did poorly. When you added the two Mexican centers into the U.S. centers, overall you've got a marginal result, which showed that Abilify® was slightly better than placebo.
But this was caused by the Mexican patients. Now, clearly, the Mexican data looks very dodgy, very shaky. The FDA knew this was happening, but didn't in any way investigate the issues. They noted that it was odd, but they didn't investigate the issues, and they didn't stop the company, later, from publishing the trial without drawing any attention to the fact that, "Well, you know, our results don't look all that good when you leave the Mexican trial centers out of the picture."

Dr. Healy's Take on the Future of Medicine

Dr. Healy doesn't cast too much blame on the FDA though, stating that the agency always has been and probably always will be an agency that contributes to public health, "but does so by regulating the wording of adverts that the pharmaceutical companies put out." He points out that it's not really the FDA's job to evaluate the product or the practice of medicine, stressing that this responsibility really falls on doctors.
"Back 30 to 40 years ago, we were a lot safer not because the FDA were doing their job better, but because doctors were doing their job better," he says.
I think it's medicine that has lost its way. I think the FDA is still doing what it has always been doing, which is a very minimal job. I mean, most people out on the street want someone there to protect them from the risk that drugs or industry may pose. They're hoping that that's the FDA, when, in fact, that has never been FDA's brief. It's been the brief of doctors to do that, and we've been failing at that job more and more in recent years."
When asked what he thinks the solution is, Dr. Healy responds:
"I think my solution is this: the job of the doctors have been like the job of the pilot of a plane. Their job is to get you from Chicago to Houston alive—not to get you there 15 minutes earlier; it's to get you there alive...
Doctors seem to have forgotten this. If they can't get you there alive; if they can't be the people whose professional identity is linked to keeping you safe when you go on treatment, they're going to be replaced by cheaper prescribers – by pharmacists or nurses. Anyone can get you on the pill these days. It takes an expert to keep you safe. I think if doctors don't realize this, they're committing professional suicide."

How You Can Get More Informed, and Be Part of the Solution

Dr. Healy is a strong advocate for doing things to make a difference. And this was the impetus behind a brand new website called His goal for this website is to create a people's movement for safer drugs.
"We want people to go in there and report any of the problems they may be having on the medicines that they're on. They can report this to FDA as well. But if they report to us, we're going to feed their reports through to FDA," Dr. Healy explains.
Potentially one of the most valuable features on the site will allow you to go through a series of questions that will help you determine whether ailments you're having are associated with any of the drugs you're taking. At the end, you will get a report that you can then bring with you to your prescribing doctor, to aid you in making a more comprehensive risk versus benefit analysis. The idea is to try and create better teamwork between you and your doctor. Furthermore, you will get feedback on potential problems with individual drugs long before you'd get it from the FDA.
I feel this could be an excellent tool for anyone currently taking any drug, as well as for anyone considering taking one. Forewarned is forearmed, as they say, and when it comes to drugs, you really need to do your due diligence, as the risks are all on you—not on your doctor, the FDA, or the pharmaceutical company.
Weighing the risks versus the benefits is crucial, but in order to do this, you need reliable, truthful information, and I believe can be a valuable resource that will only become more valuable with time, as people begin to use it and file their own reports on side effects. So please, bookmark it on your computer and refer to it whenever needed, and share it on your social networks. Together, as a community, we can help the movement for safer drugs.