Glaxo Ends Resveratrol Drug Study
Ryan McBride 12/1/10|
London-based GlaxoSmithKline has terminated a mid-stage clinical trial of SRT501 in patients with advanced multiple myeloma, the company said in a statement e-mailed to Xconomy today. The firm acquired the drug, a formulation of resveratrol, in its $720 million buyout of Cambridge, MA-based Sirtris Pharmaceuticals in 2008.
Sirtris has captured wide media attention because of the potential anti-aging benefits of the naturally occurring chemical resveratrol, which can be found in the skin of red grapes and in red wine.
SRT501 is a proprietary formulation of resveratrol, a substance found in grapes and in red wine. Resveratrol is believed to provide a number of health benefits, including preventing heart disease and potentially slowing aging processes.
Glaxo has been testing SRT501 and other resveratrol compounds in a number of diseases, including cancer and diabetes.
Glaxo decided to end the trial after a review of data from the study found that the formulation of resveratrol "may only offer minimal efficacy while having a potential to indirectly" cause kidney complications that often occur in myeloma patients, according to the company's statement. The Myeloma Beacon first reported the news about the recent decision to terminate the trial yesterday. Multiple myeloma is a type of cancer found in plasma cells.
The Phase IIa clinical trial tested the use of SRT501 with and without the approved cancer treatment bortezomib (Velcade), according to the government's clinical trials website.
Glaxo had suspended enrollment of the study in April of this year after cases of acute kidney failure were found in five study patients, according to the company. In the company's analysis of these cases, it "concluded that these renal failure cases were most likely due to the underlying disease, as kidney complications related to myeloma occur in up to 50 [percent] of cases. However, the formulation of SRT501 was not well tolerated, and side effects of nausea/vomiting/diarrhea may have indirectly led to dehydration, which exacerbated the development of the acute renal failure," the company said.
Glaxo, which continues to operate Sirtris as its subsidiary in Cambridge, said that it is now focusing on "selective SIRT1 activator compounds that have no chemical relationship to SRT501 and more favorable drug-like properties." Those selective activators include compounds known as SRT2104 and SRT2379.
Ryan McBride is Xconomy's correspondent. You can reach him at
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Glaxo Halts Resveratrol Study
By Darryl Isherwood & Darryl R. Isherwood
Published May 05, 2010
GlaxoSmithKline (GSK) halted a clinical trial seeking to explore the benefits of a chemical found in red wine.
The trial was studying the effects on cancer patients of a drug containing a reformulated version of resveratrol. Glaxo acquired the drug as part of its 2008 purchase of Sirtris Pharmaceuticals.
Glaxo halted its trial of the drug on patients with multiple myeloma after several patients developed nephropathy, a condition that can cause kidney failure.
A Sirtris official told Dow Jones that the condition is common in multiple myeloma patients, so its cause is unclear.
Resveratrol has been hailed as an anti-aging miracle drug, but recently scientists have begun to question the effectiveness. Resveratrol is thought to work by activating enzymes in the body called sirtuins.
Resveratrol: The Hard Sell on Anti-Aging
Online ads for resveratrol are using fake endorsements from experts and celebrities to promote the unproven anti-aging product
By Arlene Weintraub
July 29, 2009
Editor's note: For related a report on CBS Evening News, done in collaboration with BusinessWeek, click here, or go to CBS Evening News and search for resveratrol.
When Harvard University scientist David Sinclair discovered that a substance in red wine called resveratrol might explain the life-extending powers attributed to the beverage, he became an instant celebrity. Barbara Walters featured the youthful Australian in a 2008 ABC News TV special called Live to Be 150: Can You Do It? Sinclair also appeared on 60 Minutes and other news shows. In April 2008, GlaxoSmithKline (GSK) bought Sirtris Pharmaceuticals, the company Sinclair co-founded, for $720 million.
The media interviews were celebrations of scientific discoveries, not product promotions. But to Sinclair's chagrin, he was quickly turned into a pitchman by companies selling resveratrol supplements on the Internet. Their ads, placed alongside search results when people typed in "anti-aging" or "resveratrol," contained links with titles such as "dr-sinclair-resveratrol.com." This particular site, which appeared on the Web in June, could fool the most savvy shopper into thinking Sinclair was selling the product. "If you have been following 60 Minutes, you would have seen my segment on resveratrol, and everything it can do for you," read the text beside a photo of Sinclair. "As mentioned, I take resveratrol myself, and love it."
The site offered a free trial to anyone who typed in their credit-card number. Those who tried to click off the ad were stopped by a large boxed message, which read: "Wait! Dr. Sinclair wants to make sure you take advantage of this limited time opportunity!"
The doctor never uttered any of the words attributed to him. In fact, Sinclair is the first to admit that the whole resveratrol story has never been clear-cut. Although that name is on the label of red-grape extracts sold in health food stores everywhere, such resveratrol pills have never been proven effective in large-scale clinical trials. Resveratrol probably has some effect, Sinclair says. His lab showed that mice fed the chemicals live at least 15% longer than normal mice. But to get such benefits, human beings might have to consume up to 5 grams of resveratrol a day, he says. That's about 80 pills, at doses found in a typical bottle.
All this helps explain why resveratrol concoctions have never been endorsed by Sinclair, Sirtris, or Glaxo. The compounds Glaxo is currently developing aren't resveratrol at all; they're synthesized molecules that appear to have a much more potent biological effect-at least in lab animals. What's more, Glaxo's drugs based on Sinclair's work aren't being tested against aging, but rather to treat diseases common in the elderly such as cancer and diabetes. Asked about the resveratrol ads invoking Sinclair and Sirtris, Glaxo spokeswoman Mary Anne Rhyne said: "We're investigating the situation."
FWM Laboratories of Hollywood, Fla., which sells Resveratrol Ultra, is behind many of the ads-and has taken the brunt of customers' ire. The company sells monthly subscriptions to a handful of supplements, including acai, a Brazilian berry it promotes as a weight-loss treatment. A recent search on consumer site Complaintsboard.com brought up 1,200 posts from agitated FWM customers. The company offers 15-day free trials, but many customers don't realize the trials start when they type in their credit-card numbers, not when they receive their first shipment. It's in the fine print of the "terms and conditions" document on the company's Web site, but that can be hard to find. Some customers report that they continue to incur monthly charges long after they cancel. And when they call FWM's 800 number to complain, they're often put on hold interminably.
FWM CEO Brian Weiss says FWM doesn't create the ads, approve them, or place them on the Net. It delegates those tasks to ad networks, which the company pays to spread the word about its products. He declined to name which networks FWM uses. As for the content of the ads, Weiss says: "We don't control them." But he adds that he has five employees who troll the Internet all day for improper promotions. If they find any, they contact the network's managers and ask them to "please cease this immediately."
Internet marketing abuses have been around since the birth of the Web, but few match resveratrol when it comes to entangling dubious products with specious celebrity endorsements. Oprah Winfrey and Mehmet Oz, a Columbia University medical professor who appears regularly on her show, have both been invoked in resveratrol ads, as has TV chef Rachael Ray. The ads, served up by Google (GOOG) and other search engines, sometimes pop up as "sponsored links" on health portals and even on legitimate Web sites associated with the celebrities. And there's little these luminaries have been able to do about it-a problem that highlights certain flaws in the controversial ad-placement software used by Google and some of its competitors.
It is true Oprah and others have talked excitedly about resveratrol. Clips of these animated discussions are sometimes embedded in the Internet ads and then linked to specific products the celebrities never mention. One ad, for example, gushes: "Resveratrol Ultra is one of the most popular products. It has been featured over and over again on 60 Minutes, the Dr. Oz show, CNN, NBC and The New York Times." (It has not.)
Spokespeople for CBS (CBS), Winfrey, Oz, and Ray say their legal teams are pursuing the companies making false claims. Winfrey has posted a notice on her Web site telling fans that neither she nor Oz has endorsed any product or "online solicitation." Barbara Walters-who is seen in many of the ads schmoozing with Sinclair at his Harvard lab during last year's TV special-is not happy, either. "Bottom line: We don't like it. We try to stop it. We'll keep fighting it," says Jeffrey Schneider, senior vice-president at ABC News.
Even people who should know better have been snookered by the fake celebrity endorsements. Himani Vejandla, a PhD student in physiology at West Virginia University, ordered what she thought was a free sample of Resveratrol Ultra in June. She was reading a medical article on WebMD (WBMD) when the ad popped up, and she was impressed that experts such as Sinclair and Oz supposedly endorsed the product. But she got suspicious when the shipment arrived with no information about how to return the pills. Then FWM charged her $87.13-not once, but twice. When she complained, the company returned the first payment, but she had to file a claim with her bank to try to recover the second one after FWM's customer service people told her they had no record of the charge. "They're literally ripping people off," Vejandla says.
Florida's Better Business Bureau (BBB), which has also been inundated with complaints about FWM, slapped the company with an F rating. And the Florida Attorney General's Economic Crimes Div. in West Palm Beach has launched an investigation.
FWM's Weiss declined to comment on the investigation. He says the customer service gripes are "older complaints" and that the one-year-old company now has 24/7 phone and Web support. As for the BBB rating, he says: "We respond to every inquiry that comes from them. Their Web site isn't accurate." Regardless of Weiss' responses, says Michael Galvin, a spokesman for the BBB in Miami, "We have serious concerns about his sales techniques. He'll still have an F."
Holes in the Screen
Google has not been effective at screening out fake celebrity endorsements disseminated via its popular AdWords program. Through AdWords, companies bid on the placement of their promotions in searches and sponsored links and pay only when Web surfers click on their ads. The program accounted for most of Google's $22 billion in revenues last year. On June 15, Google formally allowed companies to cite registered trademarks in ads, including celebrity names they don't own. The point was to enable legitimate commerce: An online shoe store, for example, can attract traffic by using trademarks such as Nike (NKE).
Even so, Google says it tries to block ads that make false claims and push credit-card schemes. It recently banned false celebrity endorsements, too. The company uses automated and manual processes to weed these out. When asked why so many are getting through, a spokeswoman says: "We're doing our best."
Harvard's Sinclair wishes Glaxo, or perhaps lawyers representing the celebrities, would do more to try to stop the ads. But he may actually have opened the door to the abuse last year when he joined the scientific advisory board of Shaklee, in Pleasanton, Calif. Shaklee sells Vivix Cellular Anti-Aging Tonic, which contains resveratrol. Sinclair says he quit the post when other companies started using his name and likeness. He's opposed, he says, "to any use of my name to sell products."