The Vaccinations-Cause-Autism Fraud

Anyone who still persists in believing that childhood vaccinations have anything to do with the development of autism should read the three well-documented articles by investigative reporter Brian Deer published recently in the prestigious British Medical Journal. The first article is presented here. For those who don’t have the time, here’s a brief synopsis:

The original research article allegedly showing a causal link between vaccinations and autism was later shown to be a deliberate fraud. The paper, published in 1998 by the Lancet, was retracted in 2010 after it was shown to contain numerous misrepresentations. The paper’s author, Dr. Andrew Wakefield, was investigated by the UK General Medical Council and ultimately lost his license to practice medicine. Records released during the investigation show that Dr. Wakefield was paid nearly $700,000 by a British lawyer who was preparing a class-action lawsuit against vaccine-makers.

Since 1998, study after study has failed to validate Dr. Wakefield’s work and failed to show any causal link between childhood vaccinations and autism. And yet, some parents of autistic children still believe in that there may be a causal link. Actress Jenny McCarthy, herself a mother of an autistic child, is one of them. Ms. McCarthy has appeared on the Oprah Winfrey show to promote the vaccination-autism “cause” and has written several books about autism. I have yet to see an admission from her that she may have been wrong about vaccines.

Sorry, Ms. McCarthy, you lose on this one. Give it up before you look even more foolish than you already do.

(Topic for debate: Why do some people continue to believe in something despite overwhelming evidence in favor of just the opposite? What does that continued belief do for them?)

Eradicating a Disease

How hard is it to eradicate a disease from the planet completely? In all of history, that goal has been achieved only once – smallpox disease was eliminated finally in 1980. The smallpox virus now exists only as frozen samples in government laboratories in Russia and the U.S. It’s worth noting that it took 180 years to eradicate smallpox!

Other eradication programs, most notably one for malaria begun in 1955 and abandoned in the 1960s, have failed miserably. A few, like the ongoing $8 billion polio eradication program, have sharply reduced the economic burden and number of deaths from their respective diseases. But achieving complete eradication has proven elusive. A recent outbreak of polio in West Africa is one of the deadliest since the polio eradication program began 22 years ago.

It may be time to re-think whether eradication of any disease is a feasible goal. Perhaps containment and treatment make more sense. In all likelihood, future disease eradication proposals will be subject to careful cost-benefit analysis before they are launched.

Why is Global Warming Such a Hot-Button Issue?

Why can’t we hold a civilized conversation about global warming any more without the feeling that everyone’s minds are already made up? Some people argue that global warming is an established fact, and that human activities (most notably the burning of fossil fuels) are responsible. Others insist that the evidence in support of global warming is either not convincing, deliberately misleading, or even just plain false. It’s getting to be almost as bad as talking about abortion. How did it come to this?

One science writer suggests that part of the problem lies with a failure of climate scientists to communicate the meaning of scientific uncertainty adequately to the public. Predicting climate change far into the future IS an inexact science at the moment, but that does not mean that the climate isn’t changing. Not knowing everything is not the same as knowing nothing. I’m reminded of the common anti-evolutionist argument that evolution can’t be true because (gasp) “there are GAPS in the fossil record!”

In addition, scientists may sometimes come across as having a “we know best” attitude toward dissent, rather than a willingness to engage the dissenters in a dialogue. Scientists may need to acknowledge openly that there are things about climate change that they do not know yet. But rather than representing a failure of the scientific method, these uncertainties represent an opportunity to develop better methods and testable hypotheses so that in the future we CAN be more certain.

Assessing the Long-Term Risks of Drugs

Here’s a dilemma for you; drugs that prevent or treat chronic diseases and that therefore will probably be taken for the rest of the patient’s life are generally only tested for a only a couple of years (for safety and efficacy) before they are approved. What if the drugs have adverse effects that only become apparent when they have been taken for many years?

This concern has been raised recently by the discovery that two blockbuster drugs do in fact have long-term negative effects not seen in their initial safety studies. The class of drugs known as bisphosphonates (Fosamax, Actonel, and Boniva) widely used to prevent osteoporosis can, on rare occasion, lead to degeneration of the jawbone or to thigh fractures. And a drug called Avandia, often prescribed for diabetics to prevent heart disease, has been shown to increase the risk of heart disease in certain cases.

I'm not saying that FDA approval of these drugs in the first place was a mistake, because in some cases the benefits may still outweigh the risks. Still, it would be nice to know the long-term risks as soon as possible so that patient treatment decisions can be made with full information. The question becomes, then, how to reduce the potential long-term risk without making the drug approval process even longer than it already is. Requiring 30 years of clinical trials before a drug can be approved is clearly impractical.

Once a drug is approved, currently there is no method for effectively tracking the incidence of adverse side effects over time. Some health officials are suggesting that we develop a national drug-use database and require physicians to report all adverse effects, so that long-term effects can be determined as soon as possible. But that raises concerns over confidentiality of patient information.

What do you think?

Drug Safety in the Workplace

Should a company be permitted to fire a worker for taking a drug that is legally prescribed by a physician to treat a medical condition? That’s what happened to a worker on an auto-parts assembly line who was taking hydrocodone for back pain, according to an article in The New York Times.

You might say, “That’s not fair!”, but it’s not that simple. After all, companies have a responsibility to maintain a safe work environment. Companies can be held responsible for accidents on the job and for product defects caused by impaired workers. And in “safety-sensitive” jobs, such as airline pilot, the public has a right to expect that the employee is not impaired.

The question becomes, then, how does society achieve the right balance between the rights of workers and the responsibilities of employers? At present we know very little about just how safe various prescription drugs are in the workplace, because testing for workplace safety is not part of the normal approval process for pharmaceutical drugs.

More and more companies are requiring drug tests of their employees. Employees who test positive are sometimes fired, in part because companies aren’t sure whether or not the drug creates a safety issue and just aren’t willing to take the risk. It’s a societal problem that needs to be addressed by valid scientific research into drug safety in the workplace.

Cell Phones Can't Cause Cancer?

One of the limitations of the scientific method is that it is virtually impossible to prove that something doesn’t exist or could never happen based on empirical data alone. And if that “something” has the potential for great harm, then common sense would dictate that we should err on the side of caution and continue to assume that it could exist, or might happen. It’s what’s known as the precautionary principle.

Take cell phones and cancer, for example. Despite tens of millions of dollars spent on research, no one has ever proven that mobile phones cause brain cancer. And yet, researchers (and the public) are still unwilling to conclude that they don’t. Even the authors of a major study that once again showed no relationship between cell phones and cancer concluded: “The possible effects of long-term heavy use of mobile phones require further investigation”. Of course, that might mean more funding for their laboratory….

Physicist Bernard Leikind has taken an entirely different approach. He claims that, based on well-accepted physical principles, cell phones cannot cause cancer. He argues that the energy emitted by cell phones is not strong enough to disrupt the chemical bonds in biological molecules, period. Indeed, he claims that if it were possible for radiation energy of this type to disrupt cellular biochemical processes, there would be no life on earth because of natural sources of similar radiation energy in the environment.

Dr. Leikind has taken a lot of heat (no pun intended) from readers – see the reader-response thread after the article. But I have yet to find the flaw in his logic.

Popular Joint Pain Supplements Don't Work

The popular joint-pain supplements glucosamine and chondroitin are ineffective in reducing knee or hip pain due to osteoarthritis, according to a recent report in the British Medical Journal. The latest meta-analysis reviewed 10 previous large, randomized, controlled studies. The authors conclude that the two supplements have no effect on either patient perception of joint pain or minimum width of joint space (a clinical measure of improvement) when compared to a placebo.

Glucosamine and chondroitin are among the most popular over-the-counter supplements, with annual sales of nearly $2 billion per year. Some people swear by the two supplements because they genuinely do feel better when taking them, and I sincerely believe they’re telling the truth. But the improvements could be due to the well-known placebo effect, or to the fact that in some patients, joint pain declines over time due to natural healing processes. Anecdotal evidence can’t be generalized to a larger population.

The authors of the study see no harm in patients continuing to take the supplements if it makes them feel better. They say that neither supplement does any harm (except to lighten your wallet a little).

Texting and Fatal Driving Accidents

Text messages sent per month from hand-held phones increased more than 15-fold from 2002 to 2008. Over the same years the percentage of fatalities in which distracted driving was listed as a possible contributing factor increased from about 12% to nearly 16%.

Based on these data, the authors of a recent report speculate that texting while driving may have contributed to 16,000 additional driving fatalities between 2001 and 2007. The claim was reported in the Los Angeles Times and other papers, but is it true?

There are several problems with this report. First, the authors defined a fatality as caused by driver distraction whenever a distraction was merely listed as present. Other factors such as equipment failure, alcohol, or driver age were not considered. Second, distractions are anything that takes the driver’s attention away from driving, including texting or talking on a hand-held phone, reading an on-board navigation system (also increasingly popular these days), reaching for something, eating, drinking, putting on makeup, etc. Searching for street signs or rubbernecking another accident are also distractions. None of these were factored out in this study.

All the report really shows is that text-messaging volumes (in and out of cars) and the number of fatal accidents due to all distractions are both going up. The authors call it a correlation, but so what? A correlation does not prove causation. I’m reminded of the example presented by my thesis advisor years ago of the tight correlation between the rise in the number of telephones in the U.S. and the decline in the incidence of tuberculosis. Do telephones prevent tuberculosis? Hardly.

Is texting while driving a problem? Probably yes. Does this paper convince me that texting while driving has caused 16,000 additional fatalities? Sadly, no.

Thimerosal, Vaccines, and Autism

The tenth scientific study showing that autism spectrum disorders in children are not linked to thimerosal, a mercury-containing preservative once used in vaccines, has just been published in the journal of the American Academy of Pediatrics, adding one more to the nine others already published. In addition, the initial report that there is a link have been largely discredited. According to an article in the LA Times earlier this year, the doctor who first alleged that there was a link between autism and thimerosal has been rebuked by the British General Medical Council for the way his research was conducted, and the journal in which published his work declared that it should not have published the report.

And yet, one in four parents still persist in believing that vaccinations increase the likelihood of a child developing autism. Is there anything that could convince them otherwise?

Perhaps not. Resistance based on emotion (fear), may not be able to be overcome by scientific evidence, no matter how clear and convincing the evidence is. It’s too bad, really. It would be a shame if diseases like measles, mumps, or even polio made a comeback because not enough children had been vaccinated against them.

Stem Cell Research Continues (Temporarily)

In the long-standing battle between opponents and proponents of research involving stem cells derived from human embryos, last month a U.S. District judge issued a temporary injunction against the use of federal funds for such research (see this blog, Sept. 1). The injunction not only halted funding for future research projects that would have used stem cells derived from embryos, but also threw the funding for all current research projects into doubt. Researchers wondered whether their experimental animals would have to be euthanatized and their laboratory workers laid off.

To prevent that from happening, last week the U.S. Court of Appeals (the next step up the judicial ladder) issued a temporary injunction against the lower court’s ruling. The injunction will allow the National Institutes of Health to continue funding stem cell research temporarily, until an appeal is heard by the higher court. It also gives Congress time to act to change the law, but of course that depends on whether proponents of stem cell research can muster the votes to do so.

So now it’s in the hands of the U.S. Court of Appeals and Congress. Researchers, patient advocacy groups, and opponents of embryonic stem cell research will be watching closely. It’s time to lobby your congressman, if you have an opinion.

Injunction Against Human Stem Cell Research

In March of 2009 President Obama issued an executive order permitting the use of federal funds for research on stem cells lines derived previously from human embryos, arguing that the researchers had not destroyed the embryos themselves. The Obama executive order effectively overturned the ban of the Bush administration on the use of human embryonic stem cells for research. At the time, I reported in this blog that the Obama order might still face a legal challenge, based on a federal law called the Dickey-Wicker Amendment of 1999.

Last week it finally happened. As the result of a lawsuit filed by several Christian groups and two doctors opposed to human stem cell research, a U.S. District Court judge issued an injunction which blocks the National Institutes of Health (NIH) from implementing the Obama order. The judge argued that the Obama executive order clearly violates the language of the Dickey-Wicker Amendment, and even some supporters of the Omama order grudgingly agree. According to Harvard ethicist Louis Guenin, allowing research on cell lines merely derived from human embryonic stem cells would be like allowing research on dead bald eagles. It’s illegal to kill bald eagles, and therefore anyone doing research on bald eagles killed by someone else would be considered complicit in the crime.

If research on stem cells derived from human embryos is to continue, it appears that Congress will have to overturn the Dickey-Wicker Amendment. Whether there are sufficient votes in both houses of Congress to do so is anybody’s guess. In the meantime, funding for future projects is on hold. And while NIH’s interpretation is that currently-funded research projects can continue for now, not everyone seems to agree. We’ll have to see how this one shakes out. For starters, I’m sure we can expect the ruling to be appealed.

Dietary Supplements Deceptive Sales Practices

Dietary supplements are regulated as food products, not as drugs. Manufacturers are free to make vague claims of effectiveness, such as “improves heart health” or “boosts brain function”, but they cannot make medical claims such as “lowers high blood pressure” or “prevents Alzheimer’s”. And although their products are supposed to be safe, they’re not required to submit any data to prove it.

Now a Senate document reveals that even though the products may be labelled correctly, in sales conversations (“off-label”, so to speak) retail sales representatives of dietary supplements products are openly engaging in “deceptive and questionable sales tactics” – in other words, they’re lying to make a sale.

In testimony before a U.S. Senate committee, the General Accounting Office (GAO) reported that it had staff members ask questions of sales representatives such as: Is ginkgo biloba safe to take with aspirin? Can ginseng cure cancer? Is it okay to replace my blood pressure medication with garlic supplements? All too often they got “yes” answers when the correct answers are “no”. These answers are not just harmless sales advice – they are potentially dangerous advice and they are against the law. Action may be taken against some sellers as a result of the investigation. But for all practical purposes, it’s still “buyer beware” when it comes to the safety and efficacy of dietary supplements.

You can hear clips of some of the undercover calls at http://www.gao.gov/products/GAO-10-662T.

Studying Human Behavior

What drives human behavior? In a provocative paper published online in Behavioral and Brain Sciences last week, it is argued that much of what we believe we know about human behavior is skewed by the fact that most psychological studies are performed on WIERDs – subjects from Western, Educated, Industrialized, Rich, Democratic societies. Indeed, most human subjects used in psychological studies are from the United States, according to an article published several years ago in American Psychologist by Jeffrey Arnett. And most of the subjects are psychology undergraduate students – hardly representative of the world’s cultures as a whole.

How might this affect the results? Take for example, perception of self. Textbooks generally describe people has having a tendency to rate their own abilities as above average and to be motivated to maintain a positive image of themselves. But this may not necessarily be true for non-WEIRD cultures, who may place more emphasis on family relationships and less on personal choice or ability.

There’s nothing inherently wrong with studying WEIRDs, of course, as long as it is understood that the conclusions may not generalize to all cultures.

Reference: Henrich, Joseph et al. The Weirdest People in the World? Behavioral and Brain Sciences 33 pp. 61-83.

Antibiotic-resistant Gram-Negative Bacteria

You’ve probably never even heard of Acinetobacter baumannii or Enterobacter aerogenes. But these and other little-known gram-negative bacteria are killing tens of thousands of hospitalized patients every year, according to some estimates.

Gram-negative bacteria (so-called because of the way they are stained during the Gram staining protocol) have a cell wall structure that makes them more difficult to kill with antibiotics in the first place. But some strains of these bacteria are now resistant to every modern antibiotic we have.

In an ironic twist, two antibiotics (colistin and polymyxin B) that are somewhat effective against these resistant bacteria are still effective only because they were essentially abandoned decades ago, when it was learned that they can cause nerve and kidney damage. Now it’s become an unpleasant trade-off at times; risk death from the bacteria, or risk possible nerve and kidney damage from the antibiotics.

New antibiotics are needed, but so far there do not appear to be any “magic bullet”-type antibiotics on the horizon. This is a battle we’re slowly losing.

Potential Alzheimer's Drug Flames Out

A closely-watched drug that was supposed to offer hope to Alzheimer’s sufferers failed miserably in Phase III trials this month, according to a press release from Pfizer, one of the pharmaceutical companies involved in its development. In all likelihood all further research on the drug will stop.

It wasn’t supposed to end like this, although looking back it may not be as surprising as it sounds. The drug, called Dimebon, was actually an antihistamine previously sold only in Russia. The Phase I and Phase II trials (efficacy in animals and limited safety tests in humans) were performed in Russia, and then the drug was patented and brought to the United States for Phase III trials and future marketing as an Alzheimer’s treatment. Apparently it doesn’t work.

Although people sometimes complain (rightly) that the drug approval process in the United States is expensive and time-consuming, there’s a good reason for the process. It protects us all.

I Don't Hear You...

How does the public respond when a published scientific report shows that a dietary supplement is ineffective, or even worse, potentially harmful? To find out, scientists at the National Institutes of Health examined the sales trends of five different dietary supplements before and after the publication of negative research results. There were no significant declines in sales for four of the five supplements (saw palmetto, Echinacea, glucosamine, and St. John’s wort) after published reports that the supplement was ineffective. But sales of the fifth supplement (Vitamin E) declined about 33% after a report suggested that high doses of Vitamin E might actually be harmful.

Why did consumers ignore the reports that supplements just didn’t work, but responded to a report of potential harm? Researchers speculate that reports of harm might have higher impact because of greater news coverage, or that some supplements (such as Vitamin E) might be recommended more often by physicians who are more likely to read and understand scientific reports, or even that it depends on the type of person who takes a particular kind of supplement, the purpose of the supplement, and the availability of alternatives.

Still, it must be discouraging for public health officials to learn that consumers aren’t getting the message, don’t believe the message, or just don’t care whether their supplements work or not.

Correlation Versus Causation

According to a study of the nearly 140,000 women who were enrolled in the Women’s Health Initiative, women who breast-fed their babies had a lower risk of developing heart disease and diabetes later in life than women who did not breast-feed their babies. The headline of the New York Times article about the research read “Breast-Feeding Benefits Mothers, Study Finds”. Is this a correct summary of the research?

The answer is “NO”! This is a classic case of the common misunderstanding about the relationship between correlation and causation. Yes, there is a clear correlation between breast-feeding and a lower risk of diabetes and heart disease later in life, according to the study. But that is not proof that the act of breast-feeding is what reduces the risk. What if women who breast-fed their children are just more health conscious overall throughout life? What if they exercise more often, or have healthier diets?

A more correct headline would be “Breast-Feeding May Benefit Mothers, Study Suggests”. Indeed, the article itself goes on to say that some experts are cautioning that an association (between breast-feeding and health benefits) does not prove a causal relationship, and that more research would be needed to determine the exact cause of the effect (lower risk).

Scientific Uncertainty and Shared Responsibility

Here’s an interesting dilemma for you: An industrial chemical is known to cause a particular type of cancer in rats. A lifelong employee at the plant that makes the chemical is diagnosed with the cancer, so he sues the company for millions of dollars. Ultimately the employee loses the case and receives nothing, because the company’s lawyers argue (correctly) that the worker could have gotten the cancer from some other source, or that the worker had a genetic predisposition to cancer. In other words, the worker cannot prove scientifically beyond a reasonable doubt that his cancer was caused by exposure to the chemical while working in the company’s plant. Having won the case, the company continues to expose its current workers to the chemical.

Do we consider this to be fair, equitable, and just? Should the entire burden of uncertain science be borne by just one side?

Some lawyers are now arguing for the concept of “shared responsibility” when the scientific evidence leaves room for uncertainty. Perhaps the company should be asked to pay at least a small amount to its workers who develop the cancer as acknowledgment that their chemical might have caused the workers' cancers - not enough for the workers to have “won the lottery” or to bankrupt the company, but at least enough to help defray the workers’ medical expenses. Over time that might cause the company to reconsider continuing to expose its current workers.

What do you think?

Antibiotic-Resistant Bacteria

Researchers have recently uncovered more evidence of an increased trend toward antibiotic resistance by Staphylococcus aureus infections, this time in infections in children. As you may know, staph is a nasty little bacterium that can lead to severe skin lesions. According to the report, the percentage of staph infections that were resistant to methycillin, the antibiotic most commonly used against staph, rose from 11.8% in 2001 to 28.1% in 2006.

Health workers worry that someday our current antibiotics just won’t be very effective any more. For more on this topic, see (See “The Growing Threat of Antibiotic-Resistant Bacteria” in Human Biology 5th ed., p. 18).

REFERENCE: Naseri, I., et. al. Nationwide Trends in Pediatric Staphylococcus aureus Head and Neck Infections. Archives of Otolaryngology - Head and Neck Surgery 135:14-16, 2009.

An Impact of Humans on Evolution

In Chapter 22 of Human Biology 5th ed. (p. 513) we make the point that evolutionary processes may be impacted by human activities, such as trophy hunting for big-game animals. The evidence comes from a study of bighorn sheep. (See “Undesirable Evolutionary Consequences of Trophy Hunting”, Nature 426: 655-658, 2003). The article documents a substantial decline in body size, horn size, and reproductive success among four-year-old (young breeding age) male bighorn sheep in one location in Alberta, Canada over 30 years as the result of the hunting practices that targeted primarily the prime breeding-age males.

Is there a solution to this problem that would still allow trophy hunting? Well, yes there is, and it lies in a key concept of evolution - that the death of an individual animal after his/her reproductive years cannot affect heritable processes. Therefore, hunters should be allowed to harvest only the truly old males; males so old that they are unlikely to be competing successfully with younger, more fit males for females. In bighorn sheep this age is probably about 8 years, when the horns generally form a complete curl. Wildlife management experts are taking heed. Over the years the legal minimum horn length for bighorn sheep has risen in most wildlife management areas from 3/4 curl, to 4/5 curl, and now to full curl. The number of male bighorn sheep harvested each year has dropped, but that’s the price that has to be paid. Sound wildlife management practices based on good science will benefit us all, whether or not you hunt.

Incidentally, a more widespread problem may be commercial fishing. When minimum size limits are set, the surviving female fish are smaller, reproduce at a younger age, and produce fewer eggs. In other words, when humans harvest the big fish, the puny fish are more likely to survive to pass on their genes.