![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 8 of 8. This is the beginning of the thread.
Posted by stan_the_man70 on February 23, 2016, at 3:16:02
--------------------------quote reference
http://www.pbs.org/wgbh/frontline/film/supplements-and-safety/
--------------------------end quoteFRONTLINE, The New York Times and the Canadian Broadcasting Corporation examine the hidden dangers of vitamins and supplements, a multi billion-dollar industry with limited FDA oversight.
----------------------------------
Have you watched this show?
Talks about the FDA, the supplements industry, lobbying, quality of the supplements, problems created, investigations.
Posted by stan_the_man70 on February 23, 2016, at 3:24:59
In reply to FrontLine - Supplements and Safety - worth watchin, posted by stan_the_man70 on February 23, 2016, at 3:16:02
----------------------quote reference
http://www.sltrib.com/opinion/1739416-155/dietary-hatch-products-sen-supplements-fda
----------------------end quoteOp-ed: 20 years later, dietary supplement industry owes much to Sen. Hatch
By Loren Israelsen
First Published Oct 25 2014 07:42AM
Last Updated Oct 25 2014 07:42 amUtah is home to more than 100 dietary supplement companies, world leaders in manufacturing safe, high-quality products that enhance the health of over 150 million Americans. These companies form the vibrant base of an annual economy unsurpassed in our state. Indeed, today Utah is widely recognized as the global center for dietary supplement manufacturing.
The strength of that durable economic engine is due largely to the efforts of one man, Sen. Orrin G. Hatch. Time and again, Sen. Hatch has fought a nonsensical federal bureaucracy, building coalitions and working tirelessly for over two decades to nurture this once-fledgling industry, allowing health-conscious consumers to continue to have access to the range of vitamins, minerals, herbs, amino acids, probiotics and fish oils they seek.
We couldn't always take these freedoms for granted.
For years and yearseven decadesthe Food and Drug Administration's policies against dietary supplements were legend.
Here are but a few examples: At one point, FDA tried limit consumer access to vitamins and minerals that could be legally sold as dietary supplements. Under FDA's theory, for example, 100 mg of vitamin C could not be sold without a prescription.
Later, FDA tried to remove black currant oil from the market by saying it was an "unapproved food additive." Here was the agency's logic: the capsule surrounding the oil was the food, and the currant oil was the additive! Two federal appeals courts had to reject FDA's overreach; one court called it "nonsensical;" the other called it "Alice in Wonderland." And it was.
So, in utter frustration, we turned to Sen. Hatch, a recognized congressional leader in healthcare and a serious legislator with a reputation for protecting American freedoms.
Thus began the multi year legislative battle Sen. Hatch led to rewrite the rules governing dietary supplements. We didn't want to be "unregulated." We just wanted rational rules by which to operate.
Hatch quickly enlisted congressional allies, such as New Mexico Rep. Bill Richardson, and Iowa Sen. Tom Harkin, both staunch Democrats, who otherwise were considered defenders of FDA.
He embarked on a three-year effort, bringing together a wide coalition, including public health experts, consumer groups, industry leaders and health food stores.
Under the Utah senator's firm hand, the initiative's support grew month by month. Ultimately, more than two-thirds of the Senate and over half of the House of Representatives cosponsored the Hatch-Harkin-Richardson bill, the Dietary Supplement Health and Education Act of 1994. It was passed without dissenting vote on the last day of Congress in 1994 and signed into law by President Bill Clinton shortly thereafter.
DSHEA, as it is called, laid out a regulatory plan. But it is balanced. It codified that dietary supplements are regulated as foodsnot drugs and not food additives. It gave FDA new powers to take action against unsafe products. Now, all manufacturers must adhere to specific dietary supplement good manufacturing practices written by FDA, setting the standard for high-quality products in the marketplace. DSHEA also improved consumer access to truthful and non-misleading information about supplement products, and it established a new program to encourage research into supplements for consumers led by the National Institutes of Health.
This weekend marks 20 years since DSHEA was enacted. During these intervening years, the market has grown, and consumer choice of safe and affordable products has multiplied many times over.
Today, dietary supplements are a $7 billion industry in Utah, providing us with a host of the beneficial products we seek and forming what many consider the centerpiece of our state's growing economy.
And for that 20-year legacy, Utahns can thank Sen. Orrin G. Hatch.
---------------------------
Loren Israelsen is president of the United Natural Products Alliance, based in Salt Lake City, and is an internationally recognized expert on dietary supplements.
-----------------------------------Also feel free to read the 30 comments below.
Posted by stan_the_man70 on February 23, 2016, at 3:56:42
In reply to Sen. Orrin Hatch, posted by stan_the_man70 on February 23, 2016, at 3:24:59
--------------------quote reference
http://www.nytimes.com/2011/06/21/us/politics/21hatch.html
--------------------end quotePOLITICS | THE CHAMPIONS
Support Is Mutual for Senator and Utah Industry
By ERIC LIPTON
JUNE 20, 2011--------------------------
SALT LAKE CITY A drive along mountain-lined Interstate 15 here shows why Senator Orrin G. Hatch is considered a hero in this region nicknamed the Silicon Valley of the nutritional supplement industry.In the town of Lehi is the sprawling headquarters of Xango, where company officials praised Mr. Hatch, a Utah Republican, late last year for helping their exotic fruit juice business operate without excessive intrusion from Washington.
Up in Sandy, Utah, is 4 Life Research, whose top executives donated to Mr. Hatchs last re-election campaign after federal regulators charged the company with making exaggerated claims about pills that it says helps the immune system. And nearby in West Salem, assembly-line workers at Neways fill thousands of bottles a day for a product line that includes Youthinol, a steroid-based hormone that professional sports leagues pushed to ban until Mr. Hatch blocked them.
Senator Hatch hes our natural ally, said Marc S. Ullman, a lawyer for several supplement companies.
Mr. Hatch, who credits a daily regimen of nutritional supplements for his vigor at 77, has spent his career in Washington helping the $25-billion-a-year industry thrive.
He was the chief author of a federal law enacted 17 years ago that allows companies to make general health claims about their products, but exempts them from federal reviews of their safety or effectiveness before they go to market. During the Obama administration, Mr. Hatch has repeatedly intervened with his colleagues in Congress and federal regulators in Washington to fight proposed rules that industry officials consider objectionable.
While Congress is often stalled or bitterly divided in addressing some of the nations most pressing problems, like the economy and immigration, legislative champions like Mr. Hatch are often remarkably successful in delivering for niche industries or parochial programs. It is not unusual, of course, for lawmakers to fight for local interests, but Mr. Hatchs alliances are particularly strong and mutually beneficial.
Mr. Hatch has been rewarded with hundreds of thousands of dollars in campaign contributions, political loyalty and corporate sponsorship of his favorite causes back home.
His family and friends have benefited, too, from links to the supplement industry. His son Scott Hatch, is a longtime industry lobbyist in Washington, as are at least five of the senators former aides. Mr. Hatchs grandson and son-in-law increase revenue at their chiropractic clinic near here by selling herbal and nutritional treatments, including $35 thyroid dysfunction injections and a weight-loss product, Slim and Sassy Metabolic Blend. And Mr. Hatchs former law partner owns Pharmics, a small nutritional supplement company in Salt Lake City.
But many public health experts argue that in his advocacy, Mr. Hatch has hindered regulators from preventing dangerous products from being put on the market, including supplements that are illegally spiked with steroids or other unapproved drugs. They also say he is the person in Washington most responsible for the proliferation of products that make exaggerated claims about health benefits.
Just in the last two years, 2,292 serious illnesses, including 33 that were fatal, were reported by consumers of supposedly harmless nutritional supplements, federal records show. (These severe adverse reaction reports do not necessarily mean the supplements caused the illnesses, just that the consumers became ill after taking them.) And some of Mr. Hatchs most important supporters in Utah have faced repeated accusations of falsely claiming their products can treat almost everything, including cancer and heart disease.
Orrin Hatch certainly has a right to fight for his constituents, said Steven Novella, a clinical neurologist at the Yale School of Medicine who was a co-founder of a Web site that tracks claims by the supplement industry. But the consequences are we have an effectively unregulated market for these products, a Wild West, and people are being abused by slick marketing, and as a result taking things that are worthless or in some cases not even safe.
Mr. Hatch rejects such accusations, noting that he has repeatedly demanded that federal regulators step up enforcement of existing laws, and even worked to expand their powers.
No relationships have or will ever have any impact on my policy positions, Mr. Hatch said in a written statement. Supplements are healthy and safe, and they are a major industry in my home state of Utah.
The depth of his industry support could be put to a test over the coming year, as Mr. Hatch prepares for what could be a tough re-election fight if Representative Jason Chaffetz, a Republican, mounts a primary challenge. Mr. Chaffetz, a former executive at a Utah company that sells anti-aging and skin care products, is also an industry ally.
Several executives, though, say they cannot imagine turning their back on Mr. Hatch.
Some folks get elected, go to Washington, forget where they came from, John F. Gay, chief executive of an industry trade association, said last year in introducing Mr. Hatch at an industry convention in Las Vegas. Others get elected, go to Washington, and use the knowledge they have gained, the relationships theyve built, the power they have developed over the years of incumbency to help the folks who got them there. That is the type of person that Senator Hatch is.
Hatch to the Rescue
Just to the left of the entrance at Xangos corporate headquarters here in central Utah is the Million Dollar Club, where independent sales agents learn the pitch for the companys $40-a-bottle juice, made from a Southeast Asian fruit called the mangosteen.
One night in March, Dr. Vaughn T. Johnson, a Xango distributor, delivered part pep talk, part medical seminar, in describing extraordinary powers attributed to mangosteen. Studies showed, Dr. Johnson said, it was anti-tumor, anti-obesity, anti-aging, anti-fatigue, antiviral, antibiotic and antidepressant.
How do I know this isnt just snake oil? Dr. Johnson, an osteopathic physician, asked. Its a really simple answer. A company that is selling snake oil is not going to stay in business for almost 11 years and grow as fast as this company is growing.
When Utah became a leading center of supplements a half century ago, an industry pioneer named John R. Christopher boasted that his more than 50 herbal formulas offered almost miraculous healings.
But by the early 1990s, the Food and Drug Administration had become uneasy about the growing number of exotic product and health claims, particularly after more than 20 deaths were attributed to a natural sleep remedy. After the agency conducted raids across the country to confiscate supplements deemed unsafe or sold for unapproved uses. Mr. Hatch came to the rescue.
Under legislation he pushed through Congress, nutritional supplement companies could introduce products without F.D.A. approval, and make general health claims without proving their effectiveness or safety. The legislation covered a wide range of products not just vitamins and minerals, but also herbs, essential oils and other substances and was written to give companies a lot of leeway in their marketing claims.
It is a broad definition and that was done intentionally, said Loren D. Israelsen, a lawyer who created an association of Utah supplement businesses that helped draft and lobby for the 1994 measure.
But Xangos record illustrates how companies eager to exploit the law can go too far.
In 2006, federal regulators warned Xango that brochures improperly promoted mangosteen juice as a disease cure, not just a healthy option. Xango is among more than a dozen Utah companies cited by federal regulators over the last decade for apparent violations of the law.
Xango, whose executives are the single biggest Utah-based contributors to Mr. Hatchs political campaigns and have drawn Mr. Hatch to its headquarters to down shot glasses of their juice, blamed a marketing company that had printed the brochures. The company also insisted that it was closely monitoring distributors to make sure they did not make inappropriate claims.
But in his talk at Xango in March, Dr. Johnson who lectures across the country at other company events used some of the same language the F.D.A. had cited in its 2006 warning letter, and he referred the sales agents to a nearby company that still sold brochures making the improper claims.
Dr. Johnson also talked about his own medical research, saying he had documented how just a few ounces a day of Xango juice could reduce certain types of inflammation, including arthritis.
As a doc, Ive had a lot of patients come to me and tell me the success they are enjoying with Xango juice, he said. The key is to stay consistent, keep taking it.
Dr. Johnson, in a written statement, said his remarks broke no rules, as he was citing results of medical studies. But a Xango spokesman said the company had initiated an inquiry and would discipline Dr. Johnson if necessary.
One fact he did not mention during his presentation was that his medical license had twice been suspended by the State of Utah, most recently in 2008, state records show, for charges including improperly prescribing excessive amounts of narcotics or turning over signed, blank prescription forms to a weight-loss clinic. He can practice medicine but remains on probation.
A Surprise Threat
Mr. Hatch has been ever vigilant about any threats to the industry. When Dr. Margaret A. Hamburg was nominated in 2009 as commissioner of the food and drug agency, her record as an aggressive health commissioner for New York City set off alarms.
Industry officials worried that Dr. Hamburg might move to introduce a new wave of regulations on nutritional supplements. Mr. Hatch, who serves on the Senate committee that oversees the F.D.A., pressed Dr. Hamburg during her confirmation hearing to agree that the no new laws were needed.
Do you agree with me and all former F.D.A. commissioners that I have chatted with, Mr. Hatch asked, that the agency had sufficient authority to regulate the dietary supplement industry and to protect consumers?
Dr. Hamburg offered a diplomatic answer: This is really a complex issue. I want to take time to study and examine and work with you and others.
Mr. Hatchs instincts were correct that the industry would come under assault, but the attacks would come from other directions. And just as he has in the past, he relied on help from lobbyists, including his son and former aides.
Scott Hatch and Jack Martin, a former Hatch aide, and four other onetime aides who have worked at lobbying firms have earned at least $3.9 million in fees in the last five years representing the industry, according to Citizens for Responsibility and Ethics in Washington. (Mr. Hatchs office says his son does not lobby his father, leaving any contact between their offices up to Mr. Martin.)
I do whatever they ask me to do many times because theyve never asked me to do anything that is improper, Mr. Hatch told an industry association last year, speaking of Mr. Martin. And, besides, I believe in this industry.
The most serious threat last year came from an unexpected source: Senator John McCain, Republican of Arizona. Citing cases in which professional athletes had failed drug tests after using nutritional supplements that were secretly spiked with steroids, Mr. McCain proposed a law last February that would give the F.D.A. more power to review new ingredients in nutritional supplements before they were brought to market and require manufacturers to report any illnesses linked to supplements, not just serious ones, as Mr. Hatch had advocated.
The industry rallied, urging consumers to send e-mail messages and letters to members of Congress, including Mr. McCain, objecting to the measure.
Opponents to this bill and their well-paid Washington lobbyists have spread false statements and rumors about the legislation, which is really a disservice to consumers, and instead proudly boast that they remain largely untouchable by the F.D.A., Mr. McCain said on the Senate floor.
But after a meeting with Mr. Hatch, he soon abandoned his own legislation.
We did it! the Alliance for Natural Health, a trade group, wrote to its members. It is time to celebrate your accomplishment.
Mr. Hatch did help Mr. McCain press for some elements of his proposal pleasing the professional sports groups that had sought the legislation by getting them included in a separate Senate bill. A McCain aide said the senator considered those concessions a victory. Industry executives, who participated in the effort, believed that Mr. McCain largely backed off because he was concerned about the damage a highly motivated industry could do during his tough re-election fight in Arizona.
Mr. Hatch also worked to blunt other suggestions about the possible need for stricter regulation.
Congressional auditors issued a report last year concluding that nutritional supplement companies were too often making unjustified health claims and selling contaminated herbal products. The auditors said trace amounts of lead appeared in 37 of the 40 test cases.
At a Senate hearing, Gregory D. Kutz, the managing director for special investigations at the Government Accountability Office, held up a bottle of garlic capsules. Marketing materials, Mr. Kutz said, claimed that the pills could prevent and cure cancer, the common cold, obesity and diabetes.
If these claims were true, imagine how this product could reduce health care costs in this country? Mr. Kutz said.
A clearly annoyed Mr. Hatch pressed the G.A.O. official to acknowledge that such claims were already illegal. He also asked that auditors concede that the contaminants in the supplements were too low to pose a health threat.
Nobodys more interested in making sure that this industry works properly in the best interest of our people than I am, Mr. Hatch told Mr. Kutz. The trouble is the F.D.A. doesnt have the money to really do what it should do.
Mr. Hatch also succeeded in making sure that new restrictions on supplements the industry objected to were not included in a landmark food safety bill.
Grateful industry executives thanked Mr. Hatch at a fund-raiser during the industry convention last June.
It is important that you support your champions support people who support you, Mr. Hatch told the gathering. Even if you are a Democrat, you ought to be supporting me. Because I will help get other Democrats to straighten out their act to do what is right. And that will be a blessing to you.
Correction: June 21, 2011
An earlier version of this article rendered the name of an advocacy group incorrectly. It is Citizens for Responsibility and Ethics in Washington, not the Center for Responsibility and Ethics in Washington.---------------------------------------------
Kitty Bennett contributed research.
-----------------------------------------------------------
A version of this article appears in print on June 21, 2011, on page A1 of the New York edition with the headline: Support Is Mutual for Senator And Makers of Supplements.
----------------------------------
There are about 153 comments on the article
Posted by stan_the_man70 on February 23, 2016, at 4:33:28
In reply to FrontLine - Supplements and Safety - worth watchin, posted by stan_the_man70 on February 23, 2016, at 3:16:02
---------------------------quote reference
http://www.nytimes.com/2015/02/06/opinion/the-politics-of-fraudulent-dietary-supplements.html
---------------------------end quoteThe Opinion Pages | CONTRIBUTING OP-ED WRITER
Stupid Pills
The Politics of Fraudulent Dietary Supplements
Timothy Egan Timothy Egan
FEB. 6, 2015--------------------------------------
SALT LAKE CITY One pill makes you smarter. One pill makes you thin. One pill makes you happy. Another keeps you energized. And so what if tests conducted by scientists in New York and Canada have found that the substances behind these miracle enhancements may contain nothing more than powdered rice or houseplants. If enough people believe theyll be healthier, well, its a nice racket.
Nice, to the tune of $13 billion a year in sales. And here in Utah, which is to the dietary supplement business what Northern California is to marijuana, a huge industry has taken hold, complete with a network of doctors making unproven claims, well-connected lobbyists and entrenched politicians who keep regulators at bay.
If you want to know how we came to be a nation where everyone is a doctor, sound science is vilified and seemingly smart people distrust vaccinations, come to Utah whose state flower should be St. Johns wort. Here, the nexus of quack pharma and industry-owned politicians has produced quite a windfall: nearly one in four dollars in the supplement market passes though this state.
Were not talking drugs, or even, in many cases, food here. Drugs have to undergo rigorous testing and review by the federal government. Dietary supplements do not. Drugs have to prove to be effective. Dietary supplements do not.
These are the Frankenstein remedies botanicals, herbs, minerals, enzymes, amino acids, dried stuff. Theyre natural. Theyre not cheap. And Americans pop them like Skittles, despite recent studies showing that nearly a third of all herbal supplements on the market may be outright frauds.
The labels say Ginkgo biloba, or ginseng, or St. Johns wort. But testing announced by the state of New York this week found that the Ginkgo biloba sold by Walmart, for example, contained no Ginkgo biloba DNA it was a mixture of rice, mustard, wheat and radish.
Some of the countrys largest retailers are selling junk in a pill, a step removed from sawdust. Counting on the stupidity of consumers, the big chains dont seem to care. As of Thursday, four days after Eric T. Schneiderman, the New York State attorney general, asked retailers to pull the tested products from their shelves in his state, you could still go to Walmart online and buy the allegedly fraudulent products.
So, there is Spring Valley echinacea with a bold label reading: Immune Health selling for $8.98 a bottle on Walmarts website. It comes with a handy customer review, touting an Excellent quality product! This about a substance that contained no echinacea, according to the attorney general.
Too bad it takes Canada, or the maverick work of someone like the New York attorney general, to get at the truth of this industry, because it is so well-insulated from federal government oversight. Schneidermans investigation was prompted by an article in The New York Times Science section, reporting on Canadian findings that some of the most popular supplements were nothing but cheap fillers.
To understand how we got here, you have to go back to 1994, when Senator Orrin G. Hatch of Utah midwifed through Congress a new industry protected from all but minimal regulation. It is also an industry that would make many of his closest associates and family members rich. In turn, theyve rewarded him with sizable campaign contributions.
Even though serious illnesses, and some deaths are on the rise from misuse of these supplements, Hatch is determined to keep regulators at bay. I am committed to protect this industry and the integrity of its products, he told a gathering of potency pill-pushers and the like in Utah last fall.
In the past, Hatch has been remarkably blunt about helping his family and friends in the fake drug trade. I do whatever they ask me to do many times because theyve never asked me to do anything that is improper, Hatch said in 2011. He was referring to the firm of his son, Scott Hatch, a longtime lobbyist for the supplement industry.
Thats the political side, an all-too-familiar story of mutual beneficiaries born in the halls of Congress. But what about the medical implications? These pills and powders cant, by law, make specific claims to cure anything. So they claim to make you healthier. The consumer is left playing doctor, reading questionable assertions that course through the unfiltered garbage of the Internet.
Theres a lot of wrong information out there, warns the American Cancer Society, in its tutorial on these products. Even for those who are usually well informed, it can be hard to find reliable information about the safe use and potential risks of dietary supplements.
And there was this finding reported in the authoritative Annals of Internal Medicine: Enough is enough: Stop wasting money on vitamin and mineral supplements. Oh, those elites at the American College of Physicians, what do they know?
So, the industry keeps growing, with 65,000 dietary supplements now on the market, consumed by nearly half of all Americans. The larger issue is mistrust of authority, a willful ignorance that knows no political side. Thus, right-wing libertarians promote a freewheeling market of quack products, while left-wing conspiracy theorists disdain modern medicine in favor of anything sold as natural or vaguely countercultural. These are some of the same people who will not vaccinate their children.
Everyone wants to live longer, to be happier, to have better sex. And, if you think you can do it without exercise, or eating enough vegetables, or getting regular sleep, there are a thousand pills for you, sold not far from the candy counter. Its all based on the honor system. If you trust them, go buy some possibly Ginkgo biloba-free Ginkgo biloba, and thank Orrin Hatch for the unfettered right to be a sucker.
---------------------------------------
806 Comments
Posted by stan_the_man70 on February 23, 2016, at 5:20:39
In reply to Stupid Pills, posted by stan_the_man70 on February 23, 2016, at 4:33:28
------------------------quote reference
http://talkingpointsmemo.com/theslice/mormon-utah-valley-multilevel-marketing-thrive-doterra
------------------------end quoteHow Utah Became a Bizarre, Blissful Epicenter for Get-Rich-Quick Schemes
ByALICE HINES | JUNE 09, 2015
-----------------------
This story has been supported by the journalism nonprofit Economic Hardship Reporting Project.
Alice Hines is a writer in New York. Follow her on Twitter @alicehines.
Posted by Tabitha on February 23, 2016, at 11:08:11
In reply to Long Article, posted by stan_the_man70 on February 23, 2016, at 5:20:39
> http://talkingpointsmemo.com/theslice/mormon-utah-valley-multilevel-marketing-thrive-doterra
Good article. I did not know that MLM's were particularly big in Utah.
Posted by stan_the_man70 on February 26, 2016, at 0:17:18
In reply to Re: Long Article, posted by Tabitha on February 23, 2016, at 11:08:11
-----------------quote reference
http://www.nytimes.com/2013/12/22/us/spike-in-harm-to-liver-is-tied-to-dietary-aids.html
-----------------end quoteHEALTH
Spike in Harm to Liver Is Tied to Dietary Aids
By ANAHAD OCONNOR
DEC. 21, 2013--------------------
When Christopher Herrera, 17, walked into the emergency room at Texas Childrens Hospital one morning last year, his chest, face and eyes were bright yellow almost highlighter yellow, recalled Dr. Shreena S. Patel, the pediatric resident who treated him.
Christopher, a high school student from Katy, Tex., suffered severe liver damage after using a concentrated green tea extract he bought at a nutrition store as a fat burning supplement. The damage was so extensive that he was put on the waiting list for a liver transplant.
It was terrifying, he said in an interview. They kept telling me they had the best surgeons, and they were trying to comfort me. But they were saying that I needed a new liver and that my body could reject it.
New data suggests that his is not an isolated case. Dietary supplements account for nearly 20 percent of drug-related liver injuries that turn up in hospitals, up from 7 percent a decade ago, according to an analysis by a national network of liver specialists. The research included only the most severe cases of liver damage referred to a representative group of hospitals around the country, and the investigators said they were undercounting the actual number of cases.
While many patients recover once they stop taking the supplements and receive treatment, a few require liver transplants or die because of liver failure. Naïve teenagers are not the only consumers at risk, the researchers said. Many are middle-aged women who turn to dietary supplements that promise to burn fat or speed up weight loss.
Its really the Wild West, said Dr. Herbert L. Bonkovsky, the director of the liver, digestive and metabolic disorders laboratory at Carolinas HealthCare System in Charlotte, N.C. When people buy these dietary supplements, its anybodys guess as to what theyre getting.
Though doctors were able to save his liver, Christopher can no longer play sports, spend much time outdoors or exert himself, lest he strain the organ. He must make monthly visits to a doctor to assess his liver function.
Americans spend an estimated $32 billion on dietary supplements every year, attracted by unproven claims that various pills and powders will help them lose weight, build muscle and fight off everything from colds to chronic illnesses. About half of Americans use dietary supplements, and most of them take more than one product at a time.
Dr. Victor Navarro, the chairman of the hepatology division at Einstein Healthcare Network in Philadelphia, said that while liver injuries linked to supplements were alarming, he believed that a majority of supplements were generally safe. Most of the liver injuries tracked by a network of medical officials are caused by prescription drugs used to treat things like cancer, diabetes and heart disease, he said.
But the supplement business is largely unregulated. In recent years, critics of the industry have called for measures that would force companies to prove that their products are safe, genuine and made in accordance with strict manufacturing standards before they reach the market.
But a federal law enacted in 1994, the Dietary Supplement Health and Education Act, prevents the Food and Drug Administration from approving or evaluating most supplements before they are sold. Usually the agency must wait until consumers are harmed before officials can remove products from stores. Because the supplement industry operates on the honor system, studies show, the market has been flooded with products that are adulterated, mislabeled or packaged in dosages that have not been studied for safety.
The new research found that many of the products implicated in liver injuries were bodybuilding supplements spiked with unlisted steroids, and herbal pills and powders promising to increase energy and help consumers lose weight.
There unfortunately are criminals that feel its a business opportunity to spike some products and sell them as dietary supplements, said Duffy MacKay, a spokesman for the Council for Responsible Nutrition, a supplement industry trade group. Its the fringe of the industry, but as you can see, it is affecting some consumers. More popular supplements like vitamins, minerals, probiotics and fish oil had not been linked to patterns of adverse effects, he said.
The F.D.A. estimates that 70 percent of dietary supplement companies are not following basic quality control standards that would help prevent adulteration of their products. Of about 55,000 supplements that are sold in the United States, only 170 about 0.3 percent have been studied closely enough to determine their common side effects, said Dr. Paul A. Offit, the chief of infectious diseases at the Childrens Hospital of Philadelphia and an expert on dietary supplements.
When a product is regulated, you know the benefits and the risks and you can make an informed decision about whether or not to take it, he said. With supplements, you dont have efficacy data and you dont have safety data, so its just a black box.
Since 2008, the F.D.A. has been taking action against companies whose supplements are found to contain prescription drugs and controlled substances, said Daniel Fabricant, the director of the division of dietary supplement programs in the agencys Center for Food Safety and Applied Nutrition. For example, the agency recently took steps to remove one fat burning product from shelves, OxyElite Pro, that was linked to one death and dozens of cases of hepatitis and liver injury in Hawaii and other states.
The new research, presented last month at a conference in Washington, was produced by the Drug-Induced Liver Injury Network, which was established by the National Institutes of Health to track patients who suffer liver damage from certain drugs and alternative medicines. It includes doctors at eight major hospitals throughout the country.
The investigators looked at 845 patients with severe, drug-induced liver damage who were treated at hospitals in the network from 2004 to 2012. It focused only on cases where the investigators ruled out other causes and blamed a drug or a supplement with a high degree of certainty.
When the network began tracking liver injuries in 2004, supplements accounted for 7 percent of the 115 severe cases. But the percentage has steadily risen, reaching 20 percent of the 313 cases recorded from 2010 to 2012.
Those patients included dozens of young men who were sickened by bodybuilding supplements. The patients all fit a similar profile, said Dr. Navarro, an investigator with the network.
They become very jaundiced for long periods of time, he said. They itch really badly, to the point where they cant sleep. They lose weight. They lose work. I had one patient who was jaundiced for six months.
Tests showed that a third of the implicated products contained steroids not listed on their labels.
A second trend emerged when Dr. Navarro and his colleagues studied 85 patients with liver injuries linked to herbal pills and powders. Two-thirds were middle-aged women, on average 48 years old, who often used the supplements to lose weight or increase energy. Nearly a dozen of those patients required liver transplants, and three died.
It was not always clear what the underlying causes of injury were in those cases, in part because patients frequently combined multiple supplements and used products with up to 30 ingredients, said Dr. Bonkovsky, an investigator with the network.
But one product that patients used frequently was green tea extract, which contains catechins, a group of potent antioxidants that reputedly increase metabolism. The extracts are often marketed as fat burners, and catechins are often added to weight-loss products and energy boosters. Most green tea pills are highly concentrated, containing many times the amount of catechins found in a single cup of green tea, Dr. Bonkovsky said. In high doses, catechins can be toxic to the liver, he said, and a small percentage of people appear to be particularly susceptible.
But liver injuries attributed to herbal supplements are more likely to be severe and to result in liver transplants, Dr. Navarro said. And unlike prescription drugs, which are tightly regulated, dietary supplements typically carry no information about side effects. Consumers assume they have been studied and tested, Dr. Bonkovsky said. But that is rarely the case. There is this belief that if something is natural, then it must be safe and it must be good, he said.
-----------------------
A version of this article appears in print on December 22, 2013, on page A1 of the New York edition with the headline: Spike in Harm To Liver Is Tied to Dietary Aids
Posted by stan_the_man70 on February 26, 2016, at 0:48:41
In reply to Re: Long Article, posted by Tabitha on February 23, 2016, at 11:08:11
------------------------quote reference
http://cjasn.asnjournals.org/content/2/4/757.full
------------------------end quoteA Review of Dietary SupplementInduced Renal Dysfunction
Steven Gabardi* , Kristin Munz*, Catherine Ulbricht §
*Department of Pharmacy Services, Renal Division, Brigham and Women's Hospital, Harvard Medical School, and §Natural Standard and Department of Pharmacy Services, Massachusetts General Hospital, Boston, Massachusetts
Address correspondence to:
Dr. Steven Gabardi, Renal Division/Department of Pharmacy Services, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115-6110. Phone: 617-732-7658; Fax: 617-732-7507; E-mail: sgabardi{at}partners.org
Abstract
-------------------------
ENTIRE ARTICLE/ABSTRACT HAS NOT BEEN POSTED
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.