The New York Times reported that Saudi Arabia reported five more deaths on Wednesday from a mysterious respiratory virus that first appeared there two years ago and has since spread to at least 16 other countries, including the United States. The Saudi Health Ministry said the latest fatalities from infections caused by the virus, known as Middle East Respiratory Syndrome, or MERS, brought the total in that country to 157. Saudi Arabia accounts for the vast majority of the 171 deaths and 571 infections from the virus globally. The Saudi announcement came as the World Health Organization said in a statement that its concern about MERS â€œhad significantly increased,â€ but that there was still â€œno evidence of sustained human-to-human transmissionâ€ of the virus.
The first cases of liver problems linked to a popular weight loss supplement called OxyElite Pro began in Hawaii last May. But it wasnâ€™t until four months later that the Food and Drug Administration, the agency responsible for getting dangerous products off the market, learned of the outbreak, and the product was finally recalled in November.
Flaws in the way that dietary supplements are monitored and reported are causing potentially life-threatening delays in how long dangerous products linger on store shelves, said Dr. Pieter Cohen, an assistant professor at Harvard Medical School who has studied supplement safety problems. They are also, he said, setting the stage for similar episodes to occur again.
Writing in a recent editorial in The New England Journal of Medicine, Dr. Cohen said that one of the more significant problems in such instances is that many cases of harm are reported to doctors and poison control centers but are either delayed in reaching the F.D.A. or do not make it to the agency at all.
â€œWeâ€™ve all been working under the premise that once a dangerous supplement is identified, the F.D.A. will swiftly remove it from the market,â€ he said. â€œBut what Iâ€™ve come to realize over the last several years is that dangerous supplements remain on store shelves sometimes indefinitely or much longer than they should be.â€
Many doctors who suspect a supplement has injured a patient neglect to submit a timely report to MedWatch, the online portal that the F.D.A. maintains to help identify clusters of injury linked to harmful products, Dr. Cohen said. He noted that delays occurred in 2008, when local health departments determined that more than 200 people had suffered selenium poisoning from a brand of multivitamin. And it happened in 2011, when the Department of Defense removed a workout supplement from military bases that contained a powerful stimulant known as DMAA.
â€œIt took the F.D.A. an additional 16 months after the military ban to gather sufficient safety data from MedWatch to alert consumers about DMAAâ€™s risks,â€ he wrote. In all of these cases, he added, â€œMedWatch reports were irrelevant.â€
The F.D.A. has been stepping up efforts to make doctors more aware of the MedWatch system and to encourage them to use it to report promptly any serious reactions to drugs, supplements and other products, said Daniel Fabricant, the director of the division of dietary supplement programs in the agencyâ€™s Center for Food Safety and Applied Nutrition.
Even so, he said, doctors sometimes neglect to include critical information in their reports. Often left out are details about the product and its label, the results of any blood work or diagnostic tests, and whether the patient was using any other drugs or supplements, which can make follow-up difficult. Linking a single supplement that might contain dozens of different ingredients to an illness requires a forensic investigation that takes time, he said.
â€œI certainly understand and share Dr. Cohenâ€™s concern,â€ Dr. Fabricant said. â€œBut I do think the system has been useful and successful and instrumental in the agency taking action against products that were unsafe.â€
Before joining the F.D.A. in 2011, Dr. Fabricant was a top executive at an industry trade group, the Natural Products Association. The F.D.A. recently announced that Dr. Fabricant is leaving the agency this month to return to the trade group as its chief executive.
Dr. Cohen said that many doctors simply do not find the F.D.A. or MedWatch very helpful in dealing with patients who have ingested a tainted product. So instead they turn to poison control centers, which offer medical advice in cases where a patient ingested something toxic. Indeed, in a report last year, the Government Accountability Office noted that from 2008 to 2010, more than 1,000 adverse events related to dietary supplements were reported to poison control centers â€“ but not to the F.D.A.
â€œBecause data are not routinely shared between the centers and the agency,â€ Dr. Cohen wrote, â€œthe F.D.A. did not have access to these reports.â€
Critics of the $32 billion a year supplement industry argue that the F.D.A. is hampered by a federal law that, they say, was written largely to protect the industry, the 1994 Dietary Supplement Health and Education Act.
The law, which gives companies much leeway in how they manufacture and advertise supplements, allows them to put products on the market without F.D.A. approval. As a result, the agency has little power to stop tainted products from landing on store shelves in the first place, even though research suggests that adulteration and mislabeling are widespread.
But industry representatives like Steve Mister, the president and chief executive of the Council for Responsible Nutrition, a supplement trade group, said the problem is not the law but an overstretched F.D.A., which has not aggressively pursued the industryâ€™s bad apples. â€œThe F.D.A. is grossly underfunded, it needs more resources, and Congress can do that,â€ he said.
Dr. Cohen said that at the very least, Congress should require that supplements carry information about side effects on their packaging.
â€œRight now, even when we know that a supplement has side effects, thereâ€™s no requirement that it appear on the label,â€ he said.
Dr. Cohen also called for a nationwide surveillance system in which the F.D.A. would working with poison control centers, local health departments and the Centers for Disease Control and Prevention. The system would include a rapid response team made up of toxicologists and other experts who could investigate reports and contact doctors and patients. A pilot program based on this idea was carried out in San Francisco in 2006 and shown to be successful, but it ended after one year because funding ran out.
Such a system, Dr. Cohen said, would help the kind of patients he has treated as a general internist at the Cambridge Health Alliance in Massachusetts.
â€œI had patients who would end up hospitalized â€“ sometimes psychiatric hospitalization, sometimes kidney failure â€“ because they were taking these weight loss supplements that they hadnâ€™t been telling us about,â€ he said. â€œSince then, this has been a real focus of mine. What are these lessons Iâ€™ve learned from my clinical practice telling us about the sale of supplements throughout the United States?â€
Legislative path to preventing heroin deaths paved with tearsMinnPost photo by Sarah T. WilliamsLexi Reed Holtum, left, whose late fiancÃ© is the (tragic) inspiration behind Steve’s Law, spoke with the bill’s author, state Sen. Chris Eaton, before a community forum on heroin-related deaths last week in Brooklyn Park.
The 911 Good Samaritan + Naloxone bill â€” a.k.a. Steveâ€™s Law â€” has made steady progress through both Minnesota House and Senate committees since it was introduced at the 2014 session’s start. Last week, the Senate gave it a unanimous thumbs-up, and its next stop is a House floor vote.
The Senate endorsement was a bittersweet victory for chief author Sen. Chris Eaton, DFL-Brooklyn Center, whose daughterâ€™s fatal heroin overdose is one of many tragedies that form the bill’s backdrop.
Ariel Eaton-Willson, just 23 when she died in on May 29, 2007, was with someone when she overdosed and stopped breathing â€” someone who was too busy hiding the stash and too worried about getting busted to call 911. Alert police officers intervened, and an ambulance was called, but by the time the heroin antidote naloxone (brand-name Narcan) could be administered it was too late to save Eaton-Willsonâ€™s life.One witness after another has tearfully disclosed stories very much like Eatonâ€™s. They include Lexi Reed Holtum, whose fiancÃ© Steve Rummler (for whom the bill is named) died of a heroin overdose on July 1, 2011. Like Ariel, he was with someone when he died, someone who did not call 911 for fear of the consequences. Holtum, vice president of the Steve Rummler Hope Foundation, has worked closely (and tirelessly) with Eaton and State Rep. Dan Schoen, DFL-St. Paul Park, to secure the billâ€™s passage.
Steveâ€™s Law (S.F. 1900/H.F. 2307) would do two things: grant limited immunity to those who call 911 in good faith to save a life, and make naloxone (an antidote not only to heroin but also to opioid painkillers) more widely available to first responders, physicians, care-providers and even families with loved ones who are heroin addicts.
The proposed law has created unease among some law-enforcement officials and others who donâ€™t want to let users (and maybe even dealers) off the hook. Arguments include unduly burdening already overwhelmed first responders, precluding officers from fully investigating crime scenes, interfering with child-protection protocols and skirting medical oversight.
Arguments for the bill are simple: It saves lives. Furthermore, Holtum argues, states that have passed similar laws find that heroin overdose survivors are providing law-enforcement officers with dealer information and â€œbuilding relationships where there were none.â€
â€˜I donâ€™t like itâ€™
An audiotape of a House Civil Law Committee hearing last month captures one of the most pivotal and raw moments in the debate (at least on the House side).
Rep. Jim Newberger, R-Becker, a paramedic who said he has â€œpushed gallons of Narcan in the course of my career,â€ said that while the bill had his support, he was nevertheless aghast at the need for it.
â€œIt needs to be said that if you have to choose between letting your friend die and not going to jail, well, anyone who would enter that into the equation of their thought process is a pretty sick individual,â€ he said at the March 19 hearing.
â€œIf all you care about is, â€˜Oh my gosh … Iâ€™m not going to call 911 because my sister or my brother or my best friend is overdosing … because I donâ€™t want to get in trouble,â€™ thatâ€™s a pure reflection on someone with a very broken moral character. Anyone whoâ€™s not willing to make the minimal sacrifice to say, â€˜You know, I might get in trouble, but my buddyâ€™s going to live,â€™ Iâ€™ve got a huge issue with that.
â€œNow that Iâ€™ve had my rant, I will support this, but I donâ€™t like it.â€
â€˜One little thingâ€™
About 45 minutes later, after witnesses had had their say and some fine points of the law had been discussed, Rep. Mary Liz Holberg, R-Lakeville, took on her colleague from Becker. â€œIâ€™m sorry, Iâ€™m going to get choked up,â€ she said. And then she did.
â€œRepresentative Newberger, people that are in the throes of chemical dependency and have the highest moral character make really bad decisions because of their illness,â€ Holberg said through tears. â€œProbably because this issue is very close to me, the comments that you made I found very offensive. Parents that have kids with these problems, the ability to have just one little tool when you feel so helpless … is huge.â€
Having someone with addiction in the family, she said, is â€œlike â€˜Alice in Wonderland.â€™ You cannot believe all the crazy stuff that goes down. As somebody that attended a group for parents, we used to say that if parents of â€˜normal kidsâ€™ ever heard us talk about the things that went on in our homes and our families, they wouldnâ€™t believe it. But if you lived it, itâ€™s not an issue of moral character, and itâ€™s not an issue of making good decisions. It is a nasty, horrible illness with consequences that are beyond prediction. And the ability to have one little thing to hang onto I think is huge.â€
Hoping for some good
Shortly thereafter, the committee voted to send the bill to the House floor, complete with the immunity clause. More tinkering could be in the works. Eaton said in an interview last week that she has worked out a deal with law enforcement that would exclude first- and second-degree felony offenders from the immunity provisions.
Sheâ€™ll be glad, she said, when the work is over.
â€œIâ€™m hoping that … we get [the bill] passed and start saving lives, so that thereâ€™s at least some purpose in Arielâ€™s death, that thereâ€™s something good that comes out of it â€” other than my tears. And Iâ€™m looking forward to not having to talk about it every day. Thatâ€™s what Iâ€™ve done for a year now, and itâ€™s been therapeutic and cathartic in a way, but at the same time it always dredges up [the loss], so itâ€™s always in the forefront of my mind. Ariel died on May 29th, so weâ€™re coming up on the seventh anniversary of her death. And her birthday was April 1st. So this is kind of a crappy time of year for me.â€
Click on the link below to learn the latest in a trend among pregnant women using prescribed narcotics.