Field of Science

NEJM editorial calls data scientists "research parasites." Can Joe Biden fix this?

Vice President Joe Biden recently called for a "moonshot" to cure cancer, which President Obama announced in his State of the Union address last week. Motivated by the tragic death of his son Beau, who died last year of brain cancer, Biden says he will devote his remaining time in office, and many years after, to helping fight cancer. On his VP blog, he writes that he wants to do two things:

  1. Increase resources — both private and public — to fight cancer.
  2. Break down silos and bring all the cancer fighters together — to work together, share information, and end cancer as we know it.

I'm 100% behind the Vice President on these efforts, and I hope he succeeds beyond his wildest ambitions. But he might discover, paradoxically, that raising money–his first goal–is easy compared to the challenge of getting scientists to share data.

Exhibit A is an editorial titled "Data Sharing" that appeared in last week's New England Journal of Medicine, written by Dan Longo and Jeffrey Drazen, the deputy editor and editor-in-chief of the journal. Drazen and Longo wrote that scientists who wish to use other people's data to make new discoveries are "research parasites." Or, to be more precise, they wrote that "some front-line researchers" (none of whom are named) have this view. They also argued that "someone not involved in the generation and collection of the data may not understand the choices made in defining the parameters" and thus have no business re-analyzing the data.

The condescension implicit in this statement is deeply troubling. Drazen and Longo are saying, essentially, that only the people who originally collect a data set can truly understand it, and anyone else who wants to take a look is a parasite.

The editorial has led to a firestorm on social media. For example, Nobel Laureate Barry Marshall tweeted that
"Plenty of Nobel prizes came from a new look at other people’s data."
UC Davis professor Jonathan Eisen tweeted that the "editorial by @nejm is simply deranged," and a new Twitter account under the name ResearchParasite quickly drew many followers.

I asked Dr. Drazen if he really meant to imply that scientists who use other people's data are parasites. He and I spoke on the phone, and he emphasized that he's a strong supporter of data sharing, and that's he been traveling the country promoting a new policy to share the information from clinical trials (something that rarely happens). Just a few days ago, he and other medical journal editors proposed a new policy on clinical trial data sharing, a policy that (while not perfect) would be a big step forward.

So why, I asked him, did he use the harshly negative phrase "research parasites"? Dr. Drazen pointed out that he had heard this term from others, and that's why he enclosed the phrase in quotation marks in his editorial (true). He shared with me an update that will appear in NEJM this week, in which he and Longo will explain further; however the journal asked that I not quote from that.

I was relieved to hear that Dr. Drazen and his NEJM colleagues are supportive of data sharing, and that are implementing new, more open policies on clinical trial data sharing for the journal. I asked him if he would also state directly that he did not believe the phrase "research parasites" was accurate or appropriate. He declined to comment, though he reiterated the point that this phrase came from others, not from him or Dr. Longo.

So the attitude is clearly out there. Indeed, it's not that unusual: I have encountered similar attitudes many times in my own career, although I should quickly add that it is far from universal.

It's a simple fact today that biomedical researchers (take note, Mr. Vice President) rarely share their data with others. Unless a funding agency or a journal in which they wish to publish requires them to share, they will sit on their data forever. I've personally been involved in projects where the various participants–funded by NIH or other federal agencies–refuse to share data even with other groups in the same consortium. For example (and this is just one of thousands I could point to), the raw data behind this clinical exome sequencing study, led by Baylor College of Medicine and published in 2013 in NEJM, is not available. The data collected by the famous Framingham Heart Study, running since 1948, has been locked up by Boston University scientists for half a century, and only recently (after considerable pressure from their funders) have they agreed to let others take a look at small pieces of the data, if they beg hard enough.

Let's go back to Vice President Biden's blog, where he wrote:
"We’ll encourage leading cancer centers to reach unprecedented levels of cooperation, so we can learn more about this terrible disease and how to stop it in its tracks.... Data and technology innovators can play a role in revolutionizing how medical and research data is shared and used to reach new breakthroughs."

Again, I'm 100% behind the VP here. Biden is already meeting with cancer researchers to see what he can do to accomplish these goals, and I'm sure they will tell him what he wants to hear. In contrast, let's see what Drazen and Longo wrote in their NEJM editorial:
"...a new class of research person will emerge — people who use another group’s data for their own ends, possibly stealing from the research productivity planned by the data gatherers, or even use the data to try to disprove what the original investigators had posited. There is concern among some front-line researchers that the system will be taken over by what some researchers have characterized as “research parasites.”"
Shocking! If you share your data, someone might try to disprove your results! Could it be that a published result relies on misinterpreted data and is wrong? It took me less than a minute on Retraction Watch to find multiple articles retracted by the NEJM itself, including some that were retracted because the original data could not be found.

Disproving a claim using the same data is what reproducibility is all about, and this is one of the most important reasons that data needs to be shared. After all, if someone has distorted their data in order to reach a conclusion that isn't really justified, we need someone else–someone not invested in proving the same result–to re-analyze the data using independent methods. This is how science corrects itself.

These sentiments of the unnamed "front-line researchers" quoted by Drazen and Longo reveal the dangerously arrogant assumption that only they understand the data, and that no one should question their findings. And there's also that concern that another scientist might discover something that was missed by the original group. In what view of reality is this "stealing from the research productivity" of that group?

The phrase "research parasites" also reflects the view of some scientists that the data they collect is their property, despite the fact that their research is (frequently) funded by the public. It's time for the funding agencies to set some new ground rules: if the government funds a study, then we all own the data. Scientists who don't like the rule can find another source of funding (and believe me, they might grumble and complain, but they will do what their funders demand).

One final note: a quick scan of recent articles in the NEJM reveals that, not surprisingly, many of them rely on the human genome sequence. Did any of those authors contact the "data gatherers" to get permission to use the genome in their work? Did they offer to include the human genome sequencers as co-authors on their papers, a step that Drazen and Longo recommend? Of course not–and they shouldn't. When we publish papers, we cite the sources of our data, but we don't ask their permission nor do we include them as co-authors. Citations are the currency of modern science.

So here's some advice to Vice President Biden: don't just talk to scientists and urge them to collaborate. They'll all agree, and tell you wonderful things about their numerous collaborations, but once you leave the room, they'll go back to business as usual. If you really want to change the culture, Mr. Vice President, change the rules.

Alabama versus Clemson prediction: both teams will lose

Monday evening's college football championship game features two powerhouse teams: undefeated Clemson (14-0) versus perennial football power Alabama (13-1). With all the media attention on this game, expected to be one of the most-watched college football games ever, it's easy to find predictions for the winner. CBS has six experts all predicting an Alabama victory. SBNation lists Alabama as a one-touchdown favorite.

My prediction is different, and I'm 100% positive that I'm correct: both teams will lose. Don't get me wrong: the teams will play each other, and one of the teams will score more points, so the game itself will have a winner. But in this money-washed extravaganza, with coaches, schools, and television networks hauling in tens of millions of dollars, none of the players will be paid a single dollar.

Imagine this: the 100 players on each team's roster have spent their year entertaining millions of fans. They have played their hearts out on the field, risking injury (including the possibility of a life-altering concussion) in every game, all while pretending to be full-time college students pursuing an education. The pretense that they are "student athletes" is what allows the NCAA and the universities to maintain the fiction that players should not be compensated for their efforts on the field.

Don't get me wrong: there will be plenty of winners in Monday's game. The coaches, conferences, and colleges have already won. Alabama's head coach Nick Saban will be paid $7,087,481 this year. Clemson's coach Dabo Sweeney makes $3,305,200. Alabama and Clemson's assistant coaches make $1,500,000 and $1,404,807 respectively. USA Today calculated the total payroll of the football coaching staff for the four teams in the final two playoff games: $35,981,491, not including bonuses.

It's not just the football coaches who have won big. Athletic directors and their staffs have cashed in handsomely too. As the Washington Post reported a few weeks ago,
"In a decade, the non-coaching payrolls at the schools [in the five wealthiest athletic conferences], combined, rose from $454 million to $767 million."
The Post also compiled numbers showing that 34 football teams had staff payrolls above $1 million for non-coaching staff. Clemson has created an "associate athletic director of football administration" who alone makes $252,000.

But wait, there's more. The athletic conferences in which Alabama, Clemson, and the other major football powers play have been rewarding themselves handsomely, paying their commissioners from $2.0 to 3.5 million. As the Washington Post put it:
"As a reward for making an industry fueled by unpaid athletes more lucrative than ever, the men who run these conferences have enjoyed staggering pay hikes doled out by the leaders of many of America’s largest universities."
Much of this money comes from television contracts; the Wall St. Journal explains that the ACC (Clemson's conference) has a $3.6 billion contract with ESPN that lasts until 2027. ESPN is paying another $7.3 billion to televise the playoff and bowl games. None of that money goes to the players upon whom the entire enterprise depends.

When you watch the game on Monday (or any college football game), think about all that money going to the coaches, administrators, conference commissioners, and staff, while the players get nothing. The universities participating in this lucrative enterprise should be ashamed: they are making millions off the backs of unpaid athletes, while hiding behind the pretense that they are providing the athletes a fair return in the form of a college education. As I've written before, this is nonsense. Universities have been corrupted by the lure of cash, and they seem to have forgotten that they are in the business of educating students, not providing sports entertainment.

So yes, you will see some winners on Monday. They're the guys on both sidelines wearing headsets, making multi-million dollar salaries. After the game, they'll drive their expensive cars to their multi-million dollar homes. The players will return to their dorm rooms.

As for me, I find it increasingly difficult to enjoy watching college football. Every time a player gets shaken up by a hard tackle, I'm reminded that their playing careers are woefully short, and this might be the last time they have the chance to play in front of such a large audience. I think about how they'll feel 10 or 20 years from now, when they're limping around on bad knees while their former schools have long forgotten about them.

Colleges need to pay the players. And while they're at it, they can take steps to make sure that these students get a real education, such as offering free tuition, room, and board to the players for at least four years after they stop playing football. Until they do, all the players lose.

An immigrant's tale: why we should welcome immigrants to the U.S.

1918 obituary for my grandfather.
This week I’m taking a break from science and choosing a more personal topic for my last column of the year. Many scientists wouldn’t be here if not for the opportunities offered by a new life in the U.S., and with so much anti-immigration talk in the news recently, I wanted to offer a counterpoint.

America is famously a land of immigrants. Some families came earlier than others, but most people in the U.S. today, including me, wouldn’t be here if some recent relative didn’t immigrate. Approximately 80 million people today are either immigrants or first-generation children of immigrants, and many more are 2nd or 3rd generation.

Despite the fearmongering of current Republican presidential candidate Donald Trump, immigrants are not and have never been the cause of America’s problems. On the contrary: immigrants have been the secret of our success. A true leader wouldn’t be afraid of them. (By the way, since when did candidates demonstrate their toughness by telling everyone to be afraid?)

The picture shown here is a newspaper obituary from the summer of 1918, showing my grandfather, Bernard Salzberg, after he was reported as killed in action in World War I. Bernard came to America as a 16-year-old boy, leaving his home in Lvov (part of modern-day Ukraine, though it was in Poland at the time) to find a better life here. He wasn’t yet a citizen when the U.S. declared war in 1917. As the obituary says,
“Salzberg could have avoided service, but instead … took out his first citizen papers before joining the American fighting forces in September 1917.”
Fortunately for me, the obituary was wrong in one critical detail: my grandfather was grievously injured by poison gas, but he didn't die. He survived and eventually came home, married, and had two children, one of whom was my father.

Both of my mother's parents were immigrants as well. They fled the pogroms in Poland in 1929 and 1930, barely in time to escape the Nazis. They arrived in the U.S. during the Great Depression, when jobs were scarce, and they never had much, but life in the U.S. was nonetheless far better than in their homeland. My immigrant grandparents could scarcely have imagined that their grandchildren would include doctors, scientists, lawyers, professors, and other productive members of society.

As a scientist, immigration affects me in another way. Our graduate education system attracts many of the best students from all over the world, especially in science and engineering. I first discovered this as a graduate student at Yale, when my fellow students came from Europe, Africa, China, and South America–and this in a graduate class with fewer than 20 students. In most U.S. science departments today, the majority of our graduate students are foreign-born, and we are delighted to get them. Many of these students remain here after graduation and become valuable members of society, creating much of the innovation that drives the U.S. economy. They stay because the U.S. offers opportunities that their own countries don’t. The U.S. is a far richer country today–not just economically but culturally, intellectually, and socially–than it would be if we closed our doors to immigrants.

I’m not saying we should open our doors to unrestricted immigration: we could be overwhelmed, as Germany and Sweden have been this year. But we should recognize that when immigrants come here to stay–when they want to join the U.S. and become part of our society, with all that entails–they contribute tremendously to the country.

We shouldn’t be afraid of immigrants: we should welcome them. Happy New Year, everyone.

Over-hyped claims that antidepressants cause autism and antidepressants

Over-hyped, overstated, and probably just wrong.

That's my summary of the latest high-profile study of autism, which reports that mothers who take antidepressants increase the risk of autism in their unborn children by up to 87%. The new study, which appeared this week in the journal JAMA Pediatrics, received widespread attention, both uncritical (Washington Post, Huffington Post) and more cautious (CBS News). But it was that 87% increase that caught most people's attention.

Many scientists, including me, read this news with skepticism. It seems particularly unlikely given that exactly two years ago, another large study reported exactly the opposite conclusion. The 2013 study, published in the New England Journal of Medicine, found that antidepressant use during pregnancy was NOT associated with an increased risk of autism. What's more, the 2013 study looked at exactly the same class of antidepressants, selective serotonin uptake inhibitors (SSRIs), as the new study.

So what's going on? Was the 2013 study just wrong? It seemed the only way to answer this was to read the new study, written by Anick Bérard and colleagues. Looking over the new numbers, my conclusion is that Bérard simply tortured the data until she got the results–and the press headlines–that they wanted. Let's look a bit more closely.

Bérard and colleagues looked at 145,456 children born in Quebec between 1998 and 2009. From this total, 4,724 were born to mothers who took antidepressants (SSRIs) at some time during their pregnancy. The number of children diagnosed with autism was 1,054, about 0.7% of all babies. Only 46 of the 1,054 were born to mothers who had taken antidepressants. The study's main results concerns mothers who took antidepressants in the second or third trimester: these women accounted for 2,532 infants, of whom 31 were diagnosed with autism.

If these numbers seem confusing, try focusing on just one number: 31. The study's main conclusion–and all the headlines–are based on those 31 children diagnosed with autism whose mothers took antidepressants in their second or third trimesters.

The key results are found in Table 2 of the study. Out of 9207 infants whose mothers took antidepressants one year before getting pregnant, 82 were later diagnosed with autism. Bérard et al. found that, after adjusting for various confounders, this group of infants had no increased risk of autism. Another group was infants whose mothers took antidepressants, in the first trimester: of these 4200 infants, 40 were diagnosed with autism. Bérard et al. computed that the adjust risk for this group was 16% lower than average. This difference was not statistically significant, though.

Finally, there's the third group of 2,532 children whose mothers took antidepressants during the 2nd or 3rd trimesters. 31 of these children were later diagnosed with autism, which worked out to an increase in relative risk of 87%.

The first thing to note here is that the increase is relative, not absolute. The overall risk of autism in this study, which was consistent with other studies, was 0.7%. An 87% increase works out to a risk of 1.3% – that's an increase of 0.6% in the rate of autism. This doesn't sound nearly so dramatic as 87%.

But keep in mind that this supposed increased risk of autism is based on just 31 cases. Digging a bit deeper, we find that the way these 31 children were diagnosed was not so clear: the authors wrote that
"Autism spectrum disorder was defined as a medical service claim or hospitalization with a diagnosis of ASD."
Apparently this means only that the children were evaluated for autism, as Dr. Alison Stuebe at The Huffington Post pointed out. Bérard et al. admit this in their paper, where they report that when they restricted their analysis to children whose diagnoses were confirmed by a psychiatrist or neurologist, the number of children with autism was smaller and the increased risk was not statistically significant. In other words, if they looked only at children with confirmed autism, their main conclusion would fade away.

You also might have noticed that Bérard divided the data up in multiple ways to look for an increase in autism: they looked at mothers who took antidepressants before getting pregnant, during the first trimester, and during the 2nd and 3rd trimesters. They don't report any findings for the 2nd trimester alone, or for the 3rd trimester alone, which would have certainly involved smaller (and probably less significant) numbers.

This raises a potentially fatal problem with the study: multiple testing. Whenever a study considers more than one hypothesis, the statistics must be adjusted to account for that. If you look for an effect in ten different ways, you're more likely to find something by chance alone, so you have to find a much stronger effect in order for it to be valid. (The web comic xkcd has a great explanation of this.) Bérard doesn't explain how many hypotheses she tested, but she does write that:
"No adjustment was made for multiple comparisons; hence, we cannot rule out chance findings given the number of comparisons made."
No kidding! Upon reading this, my main question was how the journal editors let them get away with this. I guess JAMA's editors like headlines, perhaps a bit too much.

The senior author of the study, Anick Bérard, appears to have an agenda, as Slate's David Auerbach explained. Last year, she testified in a lawsuit against Pfizer, claiming that their antidepressant Zoloft caused birth defects. The judge in that case, Cynthia Rufe, threw out Bérard's testimony with the explanation that her methods were unscientific:
"Dr. Bérard’s opinions regarding Zoloft are only made possible by her departure from use of well-established epidemiological methods." 
Now, the fact that Bérard has previously testified in court cases doesn't prove that her current study is flawed, but it does indicate that she has a bias against antidepressants. This bias might explain why her study looked so hard to find an effect when the data don't seem to support it.

Finally, I should note that even if the new study is correct (and I doubt it), it completely ignores the risk of stopping medication for pregnant women with severe depression, as Dr. Alison Stuebe discussed at length at the Huffington Post. (Recall that the 2013 study I mentioned above found that there was no increased risk of autism in women taking SSRIs.) No woman should go off her medication based on this study, although I fear that the headlines from last week will have exactly that effect.

The top 5 supplements you should not take

Ginkgo trees lining a path.
Dietary supplements are big business. They are promoted for all sorts of health benefits, including weight loss, memory enhancement, body building, and cancer prevention. Many of the claims featured on websites and product packaging are not true, but that doesn’t seem to stop supplement makers from promoting them.

Unlike drugs, supplements are not regulated by the FDA. With drugs, the FDA requires that they be both safe and effective, but with supplements, they can only take action when products are tainted in some way, or when supplement makers cross the line and make specific claims about curing disease. When they do cross that line, all the FDA can do (in most cases) is issue a stern warning and tell them to stop making false claims, which has little effect. In an effort to educate the public, the FDA regularly issues warnings such as this one, telling consumers to “beware of products promising miracle weight loss,” but supplements continue to sell briskly.

Many of the best-selling supplements have little or no evidence to back up their claims, and the vast majority of people will not benefit from taking them. So here are the top 5 dietary supplements that you should not take:

1. Ginkgo biloba. Ginkgo biloba extract is made from the leaves of a beautiful tree that is native to China. It is widely advertised as a supplement that can enhance memory, stave off dementia and Alzheimer’s, and treat other conditions. I found it available from many vendors, including Target, Whole Foods, CVS, Walgreens, and others.

Alas for any hopeful consumers, ginkgo biloba doesn’t work, as scientific studies have repeatedly shown. A recent meta-analysis of 28 different trials looked at its effect on memory, executive function, and attention, and found that it had zero effect on any of these functions.

Nonetheless, web vendors such as Zooscape.com continue to promote ginkgo as a treatment for dementia and Alzheimer’s, despite having received a warning notice from the FDA stating that their advertising violates the Food, Drug, and Cosmetics Act. The FDA letter, dating from 2010, stated that ginkgo biloba is “not generally recognized as safe and effective” for dementia or Alzheimers, but the Zooscape website still claims otherwise..

2. Garcinia cambogia. “Garcinia cambogia is hot,” says Consumer Reports. Also known as the tamarind fruit, garcinia cambogia is promoted as a near-magical weight loss treatment. It does contain a substance that was once thought to have promise in treating obesity, but it’s been studied in multiple trials, all of them negative. The first trial, in 1998, concluded that
“Garcinia cambogia failed to produce significant weight loss and fat mass loss beyond that observed with placebo.” 
According to Consumer Reports, multiple studies since then have all reached the same conclusion: it doesn’t work.

Garcinia cambogia’s popularity took off after Dr. Oz promoted it on his TV show in November 2012, where he called it a “revolutionary fat buster." This episode, which has now been removed from the Dr. Oz show website, was the subject of a U.S. Senate hearing led by Sen. Claire McCaskill, who sharply criticized Oz for promoting products that aren’t back by science. Said McCaskill, "I don't know why you need to say this stuff, because you know it's not true."

I had no trouble at all finding many sources for garcinia cambogia, all of them making strong weight loss claims. Amazon.com sells many brands, including Quality Encapsulations, which calls it a “powerful appetite suppressant” that will “block the formation of new fat cells” (there’s no evidence for this). A brand called Stay Healthy, also available from Amazon, claims you can “eat like a gorilla and lose belly fat fast!”

Sorry, but no: you can’t eat like a gorilla and lose weight. At least not like a healthy gorilla.

3. St. Johns wort is a flowering plant that some people use to treat depression. In this respect, it’s in a different category from the other supplements in this list, which are used for physical rather than psychological conditions.

A double-blind, randomized, placebo-controlled trial of St. John’s wort as a treatment for major depression was published in 2002. This type of study is the gold standard for science-based medicine, and produces the most reliable results. The conclusion was clear: St. John’s wort performed worse than placebo, and the authors concluded that St. John’s work is not effective for major depression.

This might have settled things, but studies continued, and in 2008 a review article came to a different conclusion, finding that St. John’s wort was better than placebo for major depression. Even more recently, a 2011 study looking at minor (rather than major) depression found, just like the 2002 study, that St. John’s wort offers no benefit.

Thus the evidence for St. John’s wort is confusing and contradictory. One thing that is clear, though, is that St. John’s wort can have dangerous interactions with other drugs. The NIH warns that
“Combining St. John’s wort with certain antidepressants can lead to a potentially life-threatening increase of serotonin, a brain chemical targeted by antidepressants. St. John’s wort can also limit the effectiveness of many prescription medicines.” (emphasis in original)
Despite these dangers, you can buy St. John’s wort anywhere: it took me mere seconds to find dozens of choices. If you’re thinking about trying it, follow NIH’s advice and consult your physician first.

4. Glucosamin and chondroitin. These two supplements have been promoted for years as a treatment for joint pain. Scientists have run many experiments to see if they work, and some of the experiments have been mildly positive, encouraging people to give them a try. Joint pain, especially in the knees, is very common, and we don’t yet have a real cure (unless you count knee replacement). (I have chronic knee pain myself, and I would love to find a pill that would cure it.)

To finally resolve the question, NIH conducted a large $12.5 million study called GAIT, which compared glucosamin, chondroitin, celecoxib (an NSAID), and placebo. The conclusion: the only treatment that worked was celecoxib (Celebrex). In a small subset of patients with moderate to severe pain, there was a hint of a benefit for glucosamine-chondroitin, but it wasn’t significant. For patients with mild pain, only celecoxib worked better than a placebo.

So the door isn’t completely closed for this supplement: it clearly doesn't work for mild pain, but for moderate to severe pain, it might offer a small benefit, although an NSAID is better.

Of course, there’s no hint of this uncertainty in the advertising I found. For example, Puritan’s Pride says their pill “nourishes joints to improve flexibility, supports connective tissue in and around the joints," and "promotes healthy cartilege." Of course, the very bottom of their web page has a disclaimer stating that "these products are not intended to diagnose, treat, cure or prevent any disease." Oh, so why exactly should anyone purchase them?

5. Echinacea. Echinacea is a flower, similar to a daisy, that is widely used to treat the common cold. Apparently this got its start when a Swiss herbal supplement maker was erroneously told that Native American tribes used it as a cure. Regardless of the source, the use of echinacea grew, and it has now been subjected to multiple scientific studies.

What does the science say? In 2003, a randomized, placebo-controlled, double blind trial published in JAMA – again, these are the gold standard for scientific evidence – found that echinacea was not effective for treating colds in children aged 2-11, and that it appeared to causes rashes in some of them. Another study, also a randomized, placebo-controlled, double-blind trial, looked at college students, and found again that echinacea didn't work for them either: "echinacea provided no detectable benefit or harm in these college students who had the common cold." More recently, a 2014 review concluded "Echinacea products have not here been shown to provide benefits for treating colds."

Not surprisingly, though, everyone sells echinacea. The NatureMade brand just says "supports immune system health" (a vague claim that the FDA doesn't restrict). Puritan's Pride's label says the same thing. The Dr. Oz website doesn't sell echinacea, but an article there by Tod Cooperman claims that "echinacea can help you get over a cold faster and reduce symptoms." Zooscape is even bolder: it sells an echinacea tea that it advertises with the phrase "colds and flu be gone!"

Save your money. If you have a cold, echinacea won't help. I have it on very good authority, though, that chicken soup works wonders.

[For a list of the top vitamins you don't need, see my 2014 article on that topic.]

Feds arrest dietary supplement makers for fraud

In the largely unregulated world of dietary supplements, it's like the Wild West. Dramatic claims abound, most of them unsupported by evidence, and it's hard to know if any of them can be trusted. Supplement manufacturers claim their products cure cancer, Alzheimer's disease, arthritis, and more. They promise miraculous weight loss results, nebulous "boosting" of your immune system, and anti-aging benefits.

Once in a while, though, they get caught. This week the U.S. cracked down hard on several of the more egregious offenders, announcing indictments against half a dozen supplement makers, including criminal charges against one.

It's about time. Consumers everywhere should applaud these actions and encourage more. Here's what happened.

On Tuesday, November 17, the U.S. Justice Department indicted USPlabs, a major supplement manufacturer whose products include Jack3d and OxyElite Pro. The Justice Department alleged that USPlabs "doctored packaging, labeling, and other paperwork to defraud others about what the product was." Further, the indictment points out that USPlabs claims that their products are made from natural plant extracts, when instead, as one USPlabs defendant put it:
"lol stuff is completely 100% synthetic."
The fraud runs even deeper: according to the Justice Department, after an outbreak of liver injuries associated with OxyElite Pro, in which some consumers needed liver transplants to save their lives,
"they [USPlabs] promised the FDA and the public that they would stop distributing the product at issue. They didn’t. Instead, they undertook a surreptitious, all-hands-on-deck effort to sell as much of the product as they could."
The criminal indictment, which led to the arrest of six USP employees and consultants, is just one of a sweeping set of actions over the past week. The Justice Department also filed six civil cases against other supplement makers for illegally claiming their products could cure diseases. The allegations include:

  • Clifford Woods LLC illegally sold Taheebo Life Tea, Germanium, and Organic Sulfur as treatments for Alzheimer's and cancer.
  • Optimum Health (aka Lehan Enterprises) illegally sold a product called DMSO cream for arthritis and cancer.
  • Regenica Worldwide (aka Vivaceuticals) illegally sell their RegeneSlim as a disease cure, and in addition RegeneSlim contains DMAA, an unsafe food additive under the federal Food, Drug and Cosmetic Act, but does not declare DMAA as an ingredient.

Just to be clear: none of these violations have yet been proven in court. But to be even more clear: none of these products treat or cure cancer, Alzheimer's, arthritis, or any other disease.

In addition to the DOJ actions, the Federal Trade Commission indicted three more supplement manufacturers for illegal advertising claims (that's the FTC's purview). One indictment, against Chrystal Ewing and her two companies, Health Nutrition Products LLC and Classic Productions LLC, alleged that:
"In ads for W8-B-Gone, CITRI-SLIM 4 and Quick & Easy diet pills, the defendants featured bogus weight-loss experts. Citing fake scientific studies, the defendants also deceptively claimed to have clinical proof that consumers would experience a 'RAPID FAT meltdown diet program' that lets them shed five pounds in four days with one pill, or up to 20 pounds in 16 days with four pills."
Needless to say, none of those products deliver the results they claim.

It's a jungle out there. As the FTC's Jessica Rich said, "People looking for a dietary supplement to improve their health have to wade through a swamp of misleading ads. Be skeptical of ads for supplements that claim to cure diseases, reverse the signs of aging or cause weight loss without diet or exercise.”

It appears that major supplement retailers such as GNC have dropped USPlabs like a hot potato: I couldn't find OxyElite Pro on any of their sites. However, despite the indictments and arrests, USPlabs is still marketing OxyElite Pro on their own site, where they tout it as the "#1 Selling Fat Burner", with a long list of other claims. What about the liver toxicity cited by the Justice Department? The OxyElite website claims:
"OxyELITE Pro shows no side effects in well over 99% of its users. In fact, USPLabs and GNC have stated that there’s been over a billion servings of Jack3d and Oxy ELITE Pro safely taken with no problems!"
The FDA apparently disagrees: in March of this year, they issued a Medication Health Fraud notice that OxyElite Pro contains a hidden drug ingredient, fluoxetine. Fluoxetine is a type of selective serotonin reuptake inhibitor (SSRI), used for treating depression and other conditions. According to the FDA,
"SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures. In patients on other medications for common conditions (aspirin, ibuprofen, or other drugs for depression, anxiety, bipolar illness, blood clots, chemotherapy, heart conditions, and psychosis), ventricular arrhythmia or sudden death can occur."
Caveat emptor: these supplements might contain harmful ingredients. There's only one safe way to take supplements: ask your physician. Unless your doctor specifically recommends one, stay away. You'll feel better and your wallet will benefit too.

Get your wolfsbane here! Cures headaches, only $16 a bottle

Homeopathic drugs contain some pretty strange ingredients. These drugs (or perhaps I should call them potions) come in ordinary-looking packages, apparently designed to look just like real medicine, but they are not. Inside the bottles are concoctions of a wide variety of plant extracts and other substances, almost none of them effective for what’s written on the package.

This week I was browing the headache remedies at CVS, and I encountered a treatment I hadn’t seen before: Nova Headache Complex. It’s an expensive homeopathic remedy, advertised at $16.29 for a 50-ml bottle.

Because homeopaths and their treaments are unregulated, Nova can sell this stuff without having to prove that it has any effect at all on headaches. We can thank Congress for that: ever since 1938, when a homeopathic member of Congress passed the first law protecting them, homeopathic manufacturers have been allowed to forgo any testing to show that their products are safe and effective. And who decides what is homeopathic? The homeopaths themselves.

So: what does Nova’s Headache Complex contain? According to the package, it contains Aconitum Napellus 12X, Bryonia 12X, Cactus Grandiflorus 4X, Chelidonium Majus 6X, Cimicifuga Racemosa 6X, Sanguinaria Canadensis 6X, Spigelis Anthelmia 6X, Thuja Occidentalis 6X. Let's look at just the first of these.

Wolfsbane flowers
Aconitum napellus is a lovely flowering plant, commonly known as monk’s hood or wolfsbane. If that sounds ominous, it should: wolfsbane contains several highly poisonous compounds. It's listed at #3 in the top 10 deadliest plants at Zitbits, which explains:
"When ingested, an intense burning feeling in the limbs and abdomen is immediately felt. In large doses, death can occur in as little as 2-6 hours. Only 20ml of pseudaconitine is needed to kill an adult human. Its name comes the mythology that it was thought to keep away werewolves, hence ‘wolfsbane’."
Wolfsbane has been used as a poison for thousands of years, going back to Roman times. Many young readers will remember it as the main ingredient in a deadly potion in the Harry Potter books. Coincidentally, exactly one year ago, a gardener in England died after accidentally brushing against some wolfsbane flowers.

Yikes! How can they sell this stuff? Well, luckily for consumers, the 12X refers to an extreme dilution, in this instance equal to 10 raised to the 12th power, or 1 part in 1 trillion. The only reason people don’t die when they take Nova's Headache Complex is that there’s essentially no wolfsbane in it.

Fortunately, most homeopathic “drugs” don’t contain any measurable amount of their active ingredients. That’s because homeopaths think that the more you dilute a substance–even to the point where not a single molecule remains–the more potent it is. This laughably foolish notion flies in the face of modern chemistry, biology, and physics, but homeopaths believe it anyway.

What about the other ingredients? All of them are plant extracts, several of them also poisonous (including black cohosh and bloodroot). To avoid extending this discussion for many more pages, suffice it to say that none of these plants have been shown scientifically to cure headaches.

Nova Headache Complex does contain one real ingredient: 20% alcohol. That’s quite a lot, much stronger than beer or wine. Slate.com's Yvette d'Entremont demonstrated on YouTube how one can easily get drunk from a few bottles of these homeopathic products. (She used CVS's homeopathic constipation cure, which fortunately has no effect at all on constipation.) This revelation prompted NBC4 in Los Angeles to investigate why CVS was selling alcohol to minors.

Back to our headache "cure": fortunately, over-the-counter medicines such as ibuprofen, aspirin, and acetaminophen work very well for most people. If none of these work for you, drinking an alcohol solution laced with wolfsbane (or, to be more accurate, laced with nothing) won’t help either.

The FDA is currently considering whether or not to modernize its regulation of homeopathic remedies. They’ve held a hearing and solicited public comments. Interesting, the Federal Trade Commission weighed in, arguing that the FDA's current lax rules “may harm consumers and create confusion for advertisers.” I’m skeptical that the FDA will step in any time soon, but one can always hope.

Meanwhile, CVS will sell you wolfsbane for headache pain, but I hope that none of the bottles contain the deadly poisons listed on the label. If nothing else, at least you get a shot of overpriced alcohol.