Articles

Archive for

Reporting Research Misconduct

Perhaps one of the greatest threats to the enterprise of Science-Based Medicine is research fraud and misconduct. Rigorous research methods can be used to minimize the effects of bias, but when those methods themselves are the problem there is no easy fix. Related to this is the need for transparency. When fraud or misconduct is uncovered it erodes confidence in the system because it provokes speculation about how much fraud and misconduct has not been uncovered.

A recent study published in JAMA looks at one aspect of this issue – reporting of misconduct uncovered by the FDA. The good news here is that FDA trials, those that will be used to apply to the FDA for approval of a drug, are carefully monitored and inspected by the FDA. This is an important quality control measure. When the FDA uncovers misconduct it takes steps to correct it. If the misconduct is severe enough then any data that is associated with the poor research practices will be excluded from the trial so as not to taint the results. Even an entire study can be disqualified if necessary.

The problem highlighted by the study is that there is no systematic way for the FDA to communicate its findings through the peer-reviewed literature. Tainted studies, or ones that require a correction or retraction (because the violations were discovered after publication) may therefore persist in the peer-reviewed literature without any indication of the uncovered misconduct.

(more…)

Posted in: Science and Medicine

Leave a Comment (36) →

Glucosamine Update

 Stick-and-ball model of the glucosamine molecule (from the Wikimedia Commons, image by Benjah-bmm27)

Stick-and-ball model of the glucosamine molecule (from the Wikimedia Commons, image by Benjah-bmm27)

Osteoarthritis, the “wear-and-tear” type of arthritis, affects a great many of us as we grow older. Knee pain is a common symptom. The diet supplements glucosamine and chondroitin have been proposed as a more “natural” treatment than pharmaceuticals, and they are components of a number of proprietary “joint health” formulations like Osteo Bi-Flex. The GAIT study (Glucosamine/Chondroitin Arthritis Intervention Trial), compared glucosamine, chondroitin, a combination of the two, and a pharmaceutical (celecoxib) to a placebo in patients with knee pain from osteoarthritis. The only one that worked better than placebo was celecoxib. I wrote about the GAIT trial in 2008. The study was reported in the media as both negative and positive. The positive reports emphasized the subgroup analysis: in one of ten subgroups, patients with moderate to severe pain, the combination of glucosamine and chondroitin outperformed placebo. But in the subgroup of patients with mild to moderate pain, it did not. The authors themselves commented that their study was not powered to draw any conclusions from subgroups and that further studies would be required. (The “power” of a study is a measure of its ability to show an association or relationship between two variables if such a relationship exists.) Now a further study with sufficient power claims to have confirmed the subgroup findings. This may encourage some people to try glucosamine/chondroitin, but I remain skeptical.

(more…)

Posted in: Clinical Trials, Herbs & Supplements

Leave a Comment (160) →

How not to report about vaccine safety issues, Toronto Star edition

This is the original headline of the Toronto Star's scientifically incompetent and fear mongering Gardasil story. It was later changed to "Families seek more transparency on HPV vaccine."

This is the original headline of the Toronto Star‘s scientifically incompetent and fear mongering Gardasil story. It was later changed to “Families seek more transparency on HPV vaccine.”

I remember it well, because several of my readers forwarded it to me not long after it appeared on the website of the Toronto Star: An eye-catching headline proclaiming a “wonder drug’s dark side,” that “wonder drug” being Gardasil, one of two vaccines against the human papilloma virus (HPV) designed to prevent cervical cancer by preventing infection with the HPV virus. The story’s caption blared:

Hundreds of thousands of teen girls in Canada have safely taken Gardasil, a vaccine shown to prevent HPV. But a Star investigation has found that since 2008 at least 60 Canadians have experienced debilitating illnesses after inoculation. Patients and parents say the incidents point to the importance of full disclosure of risks.

There was even a video that would have been right at home on a variety of antivaccine websites, such as Age of Autism, SafeMinds, or VaxTruth:

Indeed, the video above reminded me more than anything else, of a segment from the antivaccine “documentary” that functions as antivaccine propaganda, The Greater Good, which portrays as one of its vaccine “victims” Gabi Swank, a girl whose story is not unlike that of Kaitlyn Armstrong, the teen profiled by the Star. Both girls had a deterioration of their health that appears to have happened sometime after receiving Gardasil. Both attribute their health issues to Gardasil. Neither story was examined with even a modicum of skepticism or critical thinking. In fact, part of the reason I recognized immediately how bad the Star story was derives from my previous experience examining similar stories promoted by the particularly vociferous wing of the antivaccine movement that focuses on the perceived “evils” of Gardasil. That’s something we expect from an antivaccine propaganda film like The Greater Good. We expect better from investigative journalists like David Bruser and Jesse McLean. We don’t get it.

I had meant to blog about this incident because the Star story was such a horrendously bad story from a scientific perspective, but, blogging being what it is, other topics intruded and for some reason I never got back to this topic. Over the last 11 days, however, the criticism and inept responses kept percolating along, as you will see, involving a clueless editor who lashed out at critics, a public editor who just didn’t “get it,” and a newspaper that took far too long to admit that it had screwed up epically and only then after sliming its critics. Fortunately, an excellent analysis in the Los Angeles Times by Michael Hiltzik provided me with an “in” to do the post I had wanted to do before. How the Toronto Star wrote the story is an object lesson in how not to do a vaccine safety story, and how it responded to reasonable criticism was an even more pointed lesson in how not to deal with scientific critics.

(more…)

Posted in: Science and the Media, Vaccines

Leave a Comment (228) →

The Food Babe’s war on “chemicals” heats up again

The Food Babe

[Note: This is an extra bonus post. Because The Food Babe has been in the news and I couldn’t wait until today, I discussed it at a certain not-so-super-secret blog. If you’ve read it before, it’s only somewhat modified and updated. If you haven’t, it’s new to you. Either way, feel free to comment. Completely new material by me will appear here in a scant few hours.]

It’s been a while since I’ve taken notice of Vani Hari, a.k.a. The Food Babe, the misguided “food safety” activist who sees chemicals, chemicals, chemicals everywhere and raises fears about them all, especially the ones that she can’t pronounce. The first time I took any significant notice of her was about a year ago, when she was making news for lobbying Subway to remove the “yoga mat chemical” azodicarbonamide from its bread, although I didn’t write about her here for a few months after that. As I explained at the time, azodicarbonamide is a chemical used in small amounts to mature bread dough, improve its handling properties, and produce a drier, more cohesive, and more pliable dough that holds together better during kneading by hand or machine. It is safe, breaks down during baking into small amounts of safe substances, and is only a hazard if you inhale it in powder form, where it can be a pulmonary irritant. Then, she made some astonishingly ignorant statements about beer, where she pulled the same routine, to the point where I labeled her tactics as the “appeal to yuckiness.” Basically, if something sounds yucky to her (such as isinglass, which is derived from the swim bladders of fish and is used in some beers to remove haziness and yeast byproducts), then it must be bad, either for you or just bad because it’s gross. It also turns out that The Food Babe makes quite a pretty penny spreading her ignorance and has become sought after to feature in various media appearances, such as magazine covers.

For the last few months I’ve been somewhat dreading February, because I knew Hari was poised to release her first book. As I described before, she has more than a fair amount of social media savvy and business acumen, which have allowed her to build the Food Babe brand rapidly and explains (to me at least) why she seemed to come out of nowhere on a trajectory to become as influential as Dr. Mehmet Oz. Her book, released this week, is called The Food Babe Way: Break Free from the Hidden Toxins in Your Food and Lose Weight, Look Years Younger, and Get Healthy in Just 21 Days! (Talk about ridiculously long subtitles!) You see, I knew that when it came time for Hari’s book to come out we’d be seeing a lot more of her, and unfortunately that’s what happened. As part of that publicity, Hari was featured in a fairly long feature article in The Atlantic by James Hamblin, The Food Babe: Enemy of Chemicals. It’s a relatively amusing title, to be sure, and there’s a lot that’s good about the article. Unfortunately, there’s also a lot that’s downright infuriating about it as well, the more so given that Hamblin is a physician and really should know better, but unfortunately in this piece he shows himself far more respectful of pseudoscience of the sort promoted by The Food Babe than a physician should be.
(more…)

Posted in: Nutrition, Science and the Media

Leave a Comment (57) →

A Day of Science-Based Medicine at NECSS

Screen Shot 2015-01-09 at 1.35.26 PM

A day of Science-Based Medicine, a weekend of science and skepticism

Registration for NECSS, the North-East Conference on Science and Skepticism, is now open. Included in the program will be a day of Science-Based Medicine.

Speakers will be Harriet Hall, Jann Bellamy, David Gorski, Steve Novella and Mark Crislip.

NECSS will be held April 9th–12th, 2015, in New York City at the Fashion Institute of Technology. The SfSBM program will be Friday, April 10 and you can attend one or more of the days. $95 for one day or $195 for the entire conference.

Preliminary Program  (Updated 2.15.15.  Subject to change)

09:00 – 10:00 60 minutes Registration/Will Call
10:00 – 10:10 10 minutes OPENING: Steve Novella and David Gorski
10:10 – 10:45 35 minutes: Steve Novella. SBM – Going Beyond Evidence-Based Medicine.
10:45 – 11:20 35 minutes: Harriet Hall. Chiropractic.
11:20 – 11:55 35 minutes: David Gorski. Integrative Medicine
11:55 – 12:30 35 minutes: Mark Crislip. How Acupuncture ‘Works’
12:30 – 02:00 90 minutes LUNCH
02:00 – 02:35 35 minutes Speaker 4: Jann Bellamy. Political Pseudoscience
02:35 – 03:35 60 minutes Panel 1 Discussion
03:35 – 03:50 15 minutes BREAK
03:50 – 04:35 45 minutes Q&A from Twitter & Audience
04:35 – 05:20 45 minutes SBM Jeopardy
05:20 – 05:30 10 minutes CLOSING
05:30 – 06:00 30 minutes SBM Business Meeting

For more information and to register, go to NECSS or this registration page.

The Society for Science-Based Medicine is a co-sponsor of NECSS and paid SfSBM members can get a 15% discount using the code SFSBM2015.

Posted in: Announcements

Leave a Comment (3) →

Alternative Medical Alert Systems in the News

Belvidere, NE- Bref Albright was taking an unfamiliar route home from work because of a stalled 18-wheeler when he passed by the cell phone tower. As the electromagnetic field washed over him, symptoms of his sensitivity quickly set in. He first noticed a tingling sensation throughout his body and an odd dryness in his mouth and throat. Then nausea and headache. Once the palpitations and difficulty concentrating on the road began, he knew he had to pull over in order to avoid an accident.

An elderly woman, shown here about to be strangled by a conventional doctor and/or pharmaceutical industry representative, is wearing an EmergenQi pendant

An elderly woman, shown here about to be strangled by a conventional doctor and/or pharmaceutical industry representative, is wearing an EmergenQi pendant

“Getting off the road was the right thing to do,” Albright explained. “I couldn’t risk injuring somebody else if I lost control of my truck, but it left me vulnerable. I was a sitting duck!” As expected, Albright’s condition worsened because of continued exposure to the deadly yet fundamental force of nature. Despite blurry vision and difficulty remembering his wife’s cell phone number, he managed to place a call. No answer. His wife, home brewing kombucha, had left her phone in another room.

Albright, a 53-year-old taxidermist for the Belvidere Parks Commission, then pressed the red button that activated his alternative medical emergency alert system. Within seconds, a satellite had pinpointed the location of Albright’s pendant and a team of emergency alternative medicine experts was soon on its way. While on route, a member of the team was even able to contact Albright’s wife Norleen and ask a few questions about Bref’s alternative medical history.
(more…)

Posted in: Acupuncture, Diagnostic tests & procedures, Humor

Leave a Comment (81) →

Searching for the supplement in your supplement

Should you trust what on the label?

Is what’s on the label really in the capsule?

Most of us are fortunate to live in countries where we don’t have to worry about counterfeit drugs. We can be confident that the prescription we receive, or the drugs we purchase from the pharmacy, are of high quality and contain exactly what’s on the label. But in these same countries, there’s another group of products where the risks of counterfeits are very real – it’s among the dietary supplements that are often found on the same shelves. Dietary supplements are not regulated in the same way as drug products. The American supplement industry is a multi-billion dollar free-for-all with little meaningful safety or quality regulation. Supplement quality and safety issues are in the media regularly as a result. The most recent example comes from the New York State attorney general’s office. It has accused four large retailers of selling supplements that failed to contain labelled ingredients. Testing the products with a technology called “DNA barcoding”, the AG’s office concluded that most of the products contained little to none of the labelled ingredient. And they also found ingredients that were not disclosed on the label. The AG’s office has demanded these products be removed from store shelves, and the stores stand accused of fraud. (more…)

Posted in: Herbs & Supplements

Leave a Comment (148) →

Significant Ruling Against Conversion Therapy

gay-flag

The standard features of quackery are all there. Proponents of this particular therapy claim that a normal condition is a disease. They make false claims about the cause of this disease. They then charge thousands of dollars for their fake treatment to cure the fake disease, and claim success rates that are not backed by any statistics.

In this case the fake disease is homosexuality, for which there is now a solid consensus that it is a normal variation of human sexuality. The fake treatment is conversion therapy. Recently a New Jersey judge ruled that conversion therapists cannot claim that homosexuality is a disease or disorder. The Southern Poverty Law Center reports:

Superior Court Judge Peter F. Barsio Jr. found that it “is a misrepresentation in violation of [New Jersey’s Consumer Fraud Act], in advertising or selling conversion therapy services, to describe homosexuality, not as being a normal variation of human sexuality, but as being a mental illness, disease, disorder, or equivalent thereof.”

Further:

The judge also ruled that [New Jersey conversion therapy provider Jews Offering New Alternatives for Healing (JONAH)] is in violation of the Consumer Fraud Act if it offers specific success statistics for its services when “client outcomes are not tracked and no records of client outcomes are maintained” because “there is no factual basis for calculating such statistics.”

(more…)

Posted in: Legal, Medical Ethics

Leave a Comment (190) →

Facing Decline and Death

Gawande book

Note: Atul Gawande and his book will be featured on a Frontline episode airing on PBS tonight.

We’re all going to die. (There’s nothing like starting on a positive note! :-) ) We’re all going to die, and if we are fortunate enough to survive long enough to become old, we’re all going to experience a decline of one sort or another before we die: reduced hearing and vision, less strength, poorer memory, etc. As a society, and as a medical profession, we have been reluctant to confront those issues head on. Dr. Atul Gawande faces them unflinchingly in his thought-provoking new book Being Mortal: Medicine and What Matters in the End.

In a simpler time, there were fewer old people; they were respected for their knowledge and were cared for by their families who supplied their increasing needs as age made them more dependent on others; they died at home surrounded by supportive loved ones. Today we warehouse our elders in nursing homes, where they are denied the independence of even making simple everyday choices like when to get up and when to eat. We consign them to a regimented, less enjoyable, less meaningful life; and they frequently die alone in hospitals, connected to tubes and machines.

Doctors are not always good at making it clear to terminally ill patients that they are going to die soon. They are not always good at discussing end-of-life issues and securing advance directives. They often treat end-of-life diseases so aggressively that they end up causing more suffering or even shortening lives. (more…)

Posted in: Book & movie reviews, Cancer, Medical Ethics

Leave a Comment (59) →

What do we do about politicians and physicians who promote antivaccine misinformation?

Given the ongoing (and increasing) measles outbreak linked initially to Disneyland, it’s hard for me not to revisit the topic from time to time. This time around, there are two issues I wish to discuss, one political and one that is a combination of medical and political. After all, it was just one week ago when New Jersey Governor Chris Christie stepped in it by advocating parental choice in vaccines, as if parents don’t already have a choice. He rapidly had to walk it back, and his ill-considered remarks were almost certainly not evidence that he is antivaccine. They are, however, evidence that he doesn’t understand that we do not have “forced vaccination” in this country (we have school vaccine mandates). Parents already have choice in 48 states, given that only two states (Mississippi and West Virginia) do not allow belief-based non-medical exemptions, be they religious exemptions, personal belief-exemptions, or both, to school vaccine mandates. It also came out that in 2009 while running for Governor, Christie met with Louise Kuo Habakus (who is antivaccine) and the NJ Coalition for Vaccine Choice, a very vocal NJ antivaccine coalition whose member organization list reads like a who’s who of the national antivaccine movement and includes Life Health Choices, the antivaccine organization founded by Habakus. He even wrote a letter promising that as governor he would stand with them in “their fight for greater parental involvement in vaccination decisions that affect their children.”

It’s also evidence that vaccine mandates are becoming even more politicized. Indeed, Senator Rand Paul, on the very same day, provided more such evidence when he claimed on a conservative talk radio show that he’s seen children with severe neurological problems after vaccination, the implication being that he believed these children’s problems were linked to vaccination. Later, in a testy exchange with a CNBC reporter, who asked him whether he had really said that he thought vaccines should be voluntary, Paul sarcastically replied, “I guess being for freedom would be unusual.” Later in the exchange, after repeating the same antivaccine talking points that he had related earlier in the day, he said, “The state doesn’t own the children. Parents own the children, and it is an issue of freedom.” You get the idea. He, too, ultimately had to back off a bit, famously showing himself getting vaccinated for hepatitis A, but given that Paul has had a long history of making similar comments, this was almost certainly strategic.
(more…)

Posted in: Politics and Regulation, Public Health, Religion, Vaccines

Leave a Comment (396) →
Page 6 of 228 «...45678...»