Guest Post: “Perception is Power: How the Supplement Industry Bought Deregulation” by Tien Nguyen
Oct15

Guest Post: “Perception is Power: How the Supplement Industry Bought Deregulation” by Tien Nguyen

Today’s guest post is from Tien Nguyen, an organic chemistry grad student at the University of North Carolina, Chapel Hill. Tien is passionate about science outreach through the printed word, social media, and multimedia. On Twitter @mustlovescience and at her blog Must Love Science, she posts about timely chemistry topics and showcases the educational videos about chemistry that she helps create, including “The Fresh Bread of Bel-Air”. She is also a regular contributor to the RSC Catalysis Science & Technology Blog. Here she discusses a chapter of a new book that’s galvanized her views on science communication. Take it away, Tien! In 2008, more than 200 people were poisoned by massive doses of selenium in liquid multivitamin supplements, Total Body Formula and Total Body Mega Formula. One of the victims was a telephone repairman named John Adams. As reported by the Chicago Tribune, Adams experienced severe loss of hair, fingernails and toenails and fatigue. He eventually became too exhausted to work and was forced to retire. Other symptoms of selenium poisoning include diarrhea, joint pain, cramps and blistering skin. The FDA found that on average each Total Body serving contained 40,800 micrograms instead of 200 micrograms as planned. Nearly 50,000 supplement related adverse health effects are reported each year. Most supplements, like the Total Body Formula multivitamins, have not undergone any safety testing nor were they required to by law. That’s because almost 20 years ago, Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, establishing that dietary supplements—vitamins, minerals, herbs, amino acids, enzymes, organ tissues, glandulars (materials from animal organs, glands or tissues) and metabolites—do not have to submit to FDA safety testing before being available to the public. Referring to the Act’s passage, author Dan Hurley wrote, “So began an unprecedented experiment to test whether the unbridled use of vitamins and other supplements would help or hinder health, with the American public as the guinea pig.” As long as a supplement is labelled as such and includes a disclaimer stating the lack of approval from the FDA, the bottle is cleared for supermarket shelves. If, after wide circulation, the supplement causes adverse health effects, like organ failure or death, the FDA can step in and pull it off the market. Say what? Oh, you didn’t know supplements were totally exempt from pre-market safety regulations? Neither did 68 percent of Americans, according to a 2002 Harris poll. Nor did I, until earlier this year when I reviewed Paul Offit’s new book, “Do you Believe in Magic: The Sense and Nonsense of Alternative Medicine.” He dedicates a chapter to the DSHEA, setting the stage with a...

Read More
Chemistry of the Bar: Amaretto 101
Apr19

Chemistry of the Bar: Amaretto 101

At last week’s American Chemical Society meeting in New Orleans, a group of chemists came together to discuss the latest and greatest in alcohol. No, this wasn’t on Bourbon Street. And karaoke, to-go cups, and beaded necklaces weren’t involved (as far as I know). Instead, these folks shared stories about cocktails and hangovers at the New Orleans Morial Convention Center during a symposium called “Chemistry of the Bar.” This week’s issue of Chemical & Engineering News features a column I wrote about one of the session’s presentations. Neil C. Da Costa, a researcher at International Flavors & Fragrances, in New Jersey, entertained the audience with tales of the hurricane, that rum-based drink the Big Easy is famous for. I featured Da Costa’s studies of the hurricane because of the soft spot I have for the cocktail: The first time I drank one was during my undergraduate years at, you guessed it, my first national ACS meeting. But I gave short shrift to other “Chemistry of the Bar” presentations. One particularly interesting talk was given by Jerry Zweigenbaum, a researcher at Agilent Technologies, in Delaware. Along with Alyson E. Mitchell and coworkers at the University of California, Davis, Zweigenbaum investigated the ingredients of the after-dinner liquor amaretto. If you’re like me, you might have thought that because amaretto smells like almonds, it’s made from them. Zweigenbaum says that’s not necessarily the case. According to legend, amaretto was first made in 1525 by soaking apricot kernels in alcohol. You can see the tale, conveniently located on the website of amaretto maker Disaronno, here. Apparently, one of Leonardo Da Vinci’s star pupils was asked to paint a fresco of the Madonna in the Italian city Saronno. His model was a local innkeeper who showed her gratitude by gifting the fellow a drink made from the infamous kernels. Today, Disaronno says its amaretto contains “herbs and fruits soaked in apricot kernel oil.” But the problem with alcohols like amaretto, Zweigenbaum says, is they are regulated by the Bureau of Alcohol, Tobacco, Firearms & Explosives here in the U.S., rather than by FDA. That means companies don’t have to list the beverages’ ingredients or nutritional content. So what exactly Disaronno and other amaretto companies are putting in their wares remains a mystery. Zweigenbaum decided to find out. The Agilent researcher purchased seven different brands of amaretto (he won’t divulge which ones) and tested them with various analytical techniques—headspace gas chromatography/mass spectrometry (GC/MS) and quadrupole time-of-flight liquid chromatography (Q-TOF LC), to name a few. One volatile compound stood out in all seven amaretto brands: benzaldehyde. This is the chemical that gives amaretto its sweet, yet...

Read More
FDA’s Woodcock Talks Obesity Drug Safety
May11

FDA’s Woodcock Talks Obesity Drug Safety

Janet Woodcock, head of FDA's drugs center, had a few things to say about obesity drugs at Monday's Reuters Health Summit in New York. Some of her comments weren't surprising. But some of them might offer a sliver of hope to companies hoping to succeed where Arena Pharmaceuticals, Orexigen Therapeutics, and Vivus have so far failed-- in bringing a new diet pill to market. From a Reuters story, which was brought to my attention via Twitter by David Pittman, a former C&EN contributor now working at FDA News (Thanks for the tip, David!): For diet drugs, Woodcock said companies might find success by showing benefits beyond weight loss such as a decrease in blood pressure or reversal of diabetes. "Those would be benefits you might accept more risk for," Woodcock said. The FDA recently rejected diet drugs with various safety issues from Arena Pharmaceuticals Inc (ARNA.O), Orexigen Therapeutics Inc (OREX.O) and Vivus Inc (VVUS.O). The agency also asked Abbott Laboratories Inc (ABT.N) to withdraw its diet medicine, Meridia, from the market due to heart risks and the company agreed. It's not surprising to hear Woodcock say that a potential weight loss pill's risks must be balanced by clear benefits. Having positive effects on things that can be consequences of obesity, such as blood pressure and blood sugar control, is one way of achieving that balance. Another way is to show FDA that your risks aren't all that risky. On that topic, I was intrigued to read Arena's announcementthat it isn't conducting the 12-month study FDA asked for to evaluate how its obesity drug candidate lorcaserin caused tumors in rats, and is conducting a three-month study instead. Now, what really caught my eye in Woodcock's statements was this gem: Woodcock said the FDA would not mandate additional benefits beyond weight loss diet drugs with relatively low risks. "There are some weight loss drugs out there that don't have much serious risk and cause modest weight loss and we think that's important for people," she said. Woodcock seems to be talking about drugs already on the market, but I'm not entirely sure. (Does anyone have a transcript of this talk?) This is the kind of sentence that makes me scratch my head and ask- just where does FDA's safety bar lie? We know that the experimental pills from Arena, Orexigen, and Vivus haven't cleared it. After that trio of rejections, stimulating discussions popped up on Matthew Herper's blog at Forbes and elsewhere about whether obesity drugs are dead. But maybe the key to a weight-loss drug, as opposed to a diabetes drug that happens to have the added benefit of weight...

Read More
Avandia’s Reckoning Day
Sep23

Avandia’s Reckoning Day

After years of debate over the safety of GlaxoSmithKline’s diabetes drug Avandia, U.S. and European regulatory agencies have finally made a decision about the future of the drug. European authorities have recommended suspending marketing of the drug, while FDA is severely restricting access to the drug, but seems to be leaving the door open to further actions. GSK, meanwhile, issued a press release saying it would stop promoting Avandia worldwide. Today's announcements mark yet another chapter in the Avandia saga, which began in May 2007, when Cleveland Clinic cardiologist Steve Nissen published an analysis of the combined data from 42 previous clinical trials of GSK’s diabetes drug. The results weren’t pretty: Nissen’s article in the New England Journal of Medicine claimed that patients taking Avandia were 43% more likely to have a heart attack than those who were not on the pill. The next three years brought a series of safety alerts, conflicting data analyses, advisory panels, and questions over whether GSK tried to cover up the cardiovascular safety risk associated with the drug. In July, a panel of FDA advisors had mixed views on Avandia: 12 of the 33 panelists voted to remove the drug from the market, while 10 said it could stay on the market with strong restrictions on prescribing the drug. FDA today sided with those 10 panelists and imposed strict limitations on who can take Avandia. The agency will also adjust the drug's label to reflect the safety risk. Under a risk evaluation and mitigation strategy, or REMS, Avandia can only be prescribed to new patients if they have been unable to control their blood sugar with other diabetes drugs. People already taking Avandia can continue taking the drug, but will have to register in the REMS program and sign a document saying they are aware of the cardiovascular concerns associated with the drug. FDA did not provide a clear timeline on how long it would take to implement the REMS. “We believe this action will severely limit the number of people on this drug,” Janet Woodcock said this morning in a conference call with reporters. FDA believes the REMS requirement will cause diabetics to “think twice” before they continue on the drug or start taking it, she said. FDA said about 600,000 people are currently taking Avandia, a number that the agency believes will drop precipitously under these new requirements. Patients will surely be confused by the mixed messages being sent by the agencies: after all, if it’s not safe in Europe, why would it be safe here? FDA defended its action by pointing out that European regulatory authorities lack the ability to...

Read More
Waiting For Arena, Thoughts On Meridia
Sep16

Waiting For Arena, Thoughts On Meridia

Today the second of three potential drugs in the weight-loss race is in the hot seat- Arena Pharmaceuticals' lorcaserin, which we recently learned will be called Lorqess, if approved. An FDA panel is meeting to decide whether it will recommend the drug for approval. I'm following two liveblogs of the panel, from Lisa LaMotta of Minyanville and Adam Feuerstein of TheStreet.com, and will post my thoughts on the aftermath tomorrow. Obesity drug watchers are looking for clues about today's panel based on one that happened yesterday- that was when Abbott Laboratories' obesity drug Meridia, on the market since 1997, came under FDA's microscope. Meridia works by blocking reuptake of the neurotransmitters serotonin and noradrenalin in the brain, leading to a decrease in appetite. It's effective at helping patients shed pounds, but the drug also boosts blood pressure and heart rate. So doctors and patients have had to deal with a tradeoff between weight loss efficacy and safety (this theme seems to come up a lot in the obesity drug field). Things shifted last November, when a large study called the SCOUT trial suggested that patients on sibutramine had more cardiovascular events compared to patients on placebo. As this WebMD article puts it: The drug is already not supposed to be used in patients with known cardiovascular disease. But experts said they were troubled that many patients with undiagnosed disease could be at greater risk if they use the drug to lose weight. In the aftermath, sibutramine was pulled from the market in the UK and other European nations. And stateside, concern mounted. Which brings us to yesterday's panel. The panel vote was split as to whether to keep sibutramine on the market. Of 16 panelists, 8 voted to withdraw the drug, 2 voted to keep it on the market with more strict warning label language, and 6 voted to keep it on the market with label revisions and restrictions on which doctors can prescribe the drug. (Hat tip to Shelley Wood at theheart.org for getting the vote results up on Twitter asap). So in short, it's not clear to me what will become of Meridia. As for whether the Meridia panel outcome will affect the Lorqess panel today, Leerink Swann analyst Joshua Schimmer wrote in a note to investors that FDA's safety concerns for lorcaserin/Lorqess are likely to be different than the concerns about sibutramine/Meridia. "Because lorcaserin drops both heart rate and blood pressure (albeit in a non-statistically significant manner), we believe the CV issue will not be a major issue," he wrote. But FDA's briefing documents for Lorqess had a safety surprise, which Schimmer says may come into play....

Read More