FDA Pushes Poisoned Foods And Dangerous Drugs And Of Course Gluttonous Americans Eat It Up
In another research effort, Washington State University professor Stephen Jones and researcher Kevin Murphy indicate the same is happening in our country’s wheat fields. Their conclusion shows that today’s modern wheat has less nutritional value than 100 years ago, and most of this is related to decreased protein. Today you would have to eat twice as many slices of bread to get the same nutritional value. Again, none of the breeders and growers looked at nutritional value, they were singularly working to increase yield per acre.
Fully 25% of the wheat in the world comes from the United States. In this country we get much of our nutrients from bread by making it into a hamburger, a Panini or by spreading peanut butter on our morning toast. In poor and developing countries the use our wheat in their diet may be bread alone. The loss of wheat’s nutrients could be a serious health concern.
Researchers agree that their findings are troublesome. But they also indicate consumers should not be discouraged. Fruits and vegetables remain our best source for healthy nutrients. We absolutely need them in our diet even if they are not as nutritious as they were for our grandparents. But there are shopping decisions we can make that will help us find the most nutritious products.
Use These Tips To Seek The Most Nutrient-Packed Produce:
• Look For Old Varieties. Heirloom varieties, foods produced from seed savers and other lower yielding varieties have not likely gone through the extensive breeding that lowers nutrient value.
• Seek Out Strong Colors. Research shows that the brighter the color the more nutrients it typically packs. Pick out red lettuce rather than ice berg. Select bright orange carrots, or even better, red carrots.
• Fresh Is Better. As soon as produce is harvested it starts to lose nutritional value. If your vegetable or fruit comes from another hemisphere it will have lost much of its already depleted nutrients during shipping. Also, the nutrient value may never get very high because in order to get it to you without rotting it was probably picked green. Again, shop at farm stores or farmer’s markets and select seasonal produce that has been ripened “on the vine.”
• Organic is Best. Scientific research evidences that organically grown crops hold more nutrients. Organic foods have more minerals, vitamins and they are significantly richer in other natural health-boosters. Professor Alyson Mitchell, of the University of California, Davis, found “By avoiding synthetic fertilizers, organic farmers put more stress on plants, and when plants experience stress, they protect themselves by producing phytochemicals.” Phytochemicals appear to play an important cancer inhibiting role.
It’s not all bad news however. In his study Davis indicates that not all crops are in decline. Specifically, he found that a few products are actually gaining in nutritional value. For instance, consumers want their carrots bright orange. Plant breeders found that by intensifying the color they also induced an increase in vitamin A. When consumers wanted a brighter red to the inside of a water melon it was accompanied by an increase in lycopene, which helps fight macular degeneration and may have cancer inhibiting properties. When marketers wanted sweeter pineapples, the increase in sugar also resulted in an increase in vitamin C.
These impressive results are just a side effect of trying to make specific crops more marketable. If as consumers we demand more nutrition in our foods, and if we make purchasing decisions that favor more nutritional products, it will happen. Now, eat your vegetables.
Food Additives: The FDA Permits Use Of Hormone Disrupting Chemicals In Canned Foods And Food Packaging.
The FDA Has Failed To Take Action On Known Health Threats
Hand Soaps: Triclosan and triclocarban, both hormone disrupting chemicals, continue to be used in “antibacterial” hand soaps more than 30 years after risks were first identified.
Meat Production: FDA has failed to address the connection between the misuse of antibiotics in meat production and the rise of antibiotic resistant bacteria.
Shampoos: Despite Safer Alternatives, FDA Allows The Toxic Chemical Lindane, A Neurotoxin And Endocrine Disruptor, In Lice Treatments.
The FDA Has Conducted Insufficient Testing
Produce: The FDA Only Tests A Minuscule Fraction Of Fruits And Vegetables For Harmful Pesticide Residues.
Seafood: The FDA Relies On Outdated And Minimal Mercury Testing And Fails To Monitor For Other Chemical Contaminants In Seafood.
When the FDA was created more than 100 years ago, it was tasked with assuring the safety of human and animal drugs and our nation’s food supply. In recent years, however, the FDA has been plagued by scandalous mistakes that have shaken public confidence: failing to protect people from dangerous drugs, widespread contamination outbreaks in foods such as spinach and eggs, and tainted imports, such as dog food and milk products containing melamine.
Sadly, These Examples Are Only The Tip Of The Iceberg
To Protect Public Health The FDA Should:
* Set Health-Protective Standards For Chemical Contaminants Such As Bisphenol A (BPA) And Phthalates In Food And Personal Care Products.
* Use Modern Scientific Methods To Monitor The Food Supply For Chemical Contaminants Including Pesticides.
* Finalize Long-Delayed Decisions, Such As A Ban On Ineffective And Toxic “Anti-Microbial” Chemicals In Soaps.
* Eliminate The Unnecessary Use Of Antibiotics On Healthy Livestock In Order To Preserve Lifesaving Medicines For Sick People.
* Ban The Toxic Chemical Lindane From Lice Shampoos And Lotions.
* Improve Food Safety By Setting A Health-Protective Standard For Oil-Related Carcinogens And Toxins In Seafood.
* Improve FDA Accountability And Scientific Credibility
A Closer Look At Reform Priorities For The FDA
Gulf Coast Seafood
The BP oil spill contaminated the food chain of one of the most productive fisheries in the U.S. with oil, polycyclic aromatic hydrocarbons (PAHs) and heavy metals. The FDA’s risk assessment and policies for re-opening these areas to fishing significantly underestimated the potential health risks to vulnerable populations such as pregnant women, children, and local subsistence fishers. The risk assessment methods FDA used to calculate allowable levels of oil spill contaminants in Gulf seafood relied on outdated science. As a result, FDA set levels up to 10,000 times too high to protect the most vulnerable populations from increased cancer risk resulting from exposure to PAHs.
Endocrine Disruptors As Food Additives
Thousands of chemicals have been approved for use in food, including hormone disrupting chemicals such as BPA and phthalates, despite the fact that food is a major source of exposure to these known reproductive and developmental toxicants. Thousands of other additives have been allowed for use in food without adequate toxicity testing, and the FDA continues to rely on outdated science when reviewing chemical safety.
Toxic chemicals in hand soaps and other personal care products
Consumers in the United States spend almost $1 billion per year on "antibacterial" soaps and other products containing the active ingredients triclosan or triclocarban, resulting in widespread environmental and human contamination. Though the FDA has stated that there are valid concerns about the effects of daily use of these products, and that there is no evidence that they are any more effective than plain soap and water, it has failed to finalize a document first drafted in 1978 that would prohibit their use.
Misuse of Antibiotics In Meat Production
Approximately 70% of the antibiotics used in the U.S. are used on animals at low doses in feed and water. The aim is to promote faster weight gain in livestock and help prevent infection created by unsustainable, and often unsanitary, practices that cram thousands of animals together in "factory farms." Many of these antibiotics are also used in humans or affect drugs used in human medicine, and their misuse in agriculture has been linked to the public health crisis of antibiotic resistance in humans. The FDA has recognized this threat since the mid-1970s, but has largely failed to address the problem.
Failure To Ban Lindane, A Toxic Pesticide, For Use In Shampoos And Creams
Lindane is a DDT-related pesticide, a known neurotoxic and hormone disruptor that accumulates in body fat where it lingers for years. It has been banned by the U.S. Environmental Protection Agency and is being phased-out globally by international treaty. Despite that, the FDA still allows the use of lindane to treat head lice and scabies, even though safer alternatives are readily available.
Pesticide Residue Monitoring
Food imports have more than doubled over the past decade, with seafood and fresh produce at the top of the list of imported products. But the FDA’s monitoring of pesticide residues on produce remains woefully inadequate. The FDA tests only 0.00002% of the fruits and vegetables available for sale, and then looks for only a fraction of the toxic pesticides used on produce. Even with this limited testing, the FDA routinely finds unacceptable levels of pesticide residues, suggesting that this is a widespread and unaddressed public health issue. Adding to the concern are recent studies that suggest that residues on food may be an important route by which kids are exposed to harmful pesticides.
The FDA conducts no comprehensive assessment of chemical contaminants in seafood despite concerns about the presence of multiple contaminants ranging from metals, particularly mercury, to hormones and antibiotics. And it’s not just imported seafood. In 2010, the FDA allowed the resumption of commercial shrimp harvesting in coastal waters following the BP oil spill based on the results of only 67 samples.
Conflict of Interest Scandal Rocks FDA
Much has been made of Health and Human Services Secretary Kathleen Sebelius’ decision last month to overrule Food and Drug Administration scientists and prohibit the over-the-counter sale of the morning after pill to minors. Many observers blasted the move as a blatant political move by the White House, which didn’t want to antagonize social conservatives ahead of this year’s election.
Now there is the possibility politicians on Capitol Hill are also influencing some choices being made at the FDA. It involves the agency’s decision last month to appoint at least three scientists to a high-profile drug safety advisory committee without disclosing they had conflicts of interest with the company – Bayer – whose product – birth control pills – was up for review.
The committee recommended that Bayer be allowed to keep its problematic birth control pills – sold as Yaz and Yasmin – on the market even though the agency’s adverse events reporting system had turned up dozens of deaths from blood clots. Thousands of lawsuits have been filed against the company alleging the pills damaged women’s health. Still, the committee said the benefits of having another birth control option on the market outweighed the risks.
The vote was close – 15-11 – and dogged by controversy. Before the meeting, the FDA ruled that the safety committee’s usual consumer representative, Dr. Sidney Wolfe from Public Citizen, a long-time thorn in industry’s side, couldn’t participate because his newsletter, “Worst Pills, Best Pills,” had already called for banning the drugs. In addition, the agency refused to distribute a long legal and scientific brief prepared for plaintiffs’ attorneys by Dr. David Kessler, who once headed the agency. He submitted it too late, the agency ruled.
The latest scandal was turned up by investigative reporters for the British Medical Journal, where many of the studies outlining the risks from birth control pills first appeared. Their report, which appeared earlier this week in the Washington Monthly, revealed that at least three obstetricians/gynecologists on the committee had financial ties to Bayer. Not only that, the FDA knew about the financial conflicts of interest and didn’t tell the public.
The Wall Street Journal on Wednesday followed up with some juicy details about the ties between some of the researchers and Bayer. For instance, Dr. Paula Hillard, an obstetrics professor at Stanford University School of Medicine, attended two meetings sponsored by the company in 2010 to help it deal with the blood clot controversy, and was paid “less than $10,000” for her efforts, the paper reported. She, like the others named in the Monthly article, voted to keep the pills on the market.
So where does Capitol Hill come in? Last October, Senators Michael Bennet (D-Co.), Richard Burr (R-N.C.), and Amy Klobuchar (D-Minn.) introduced legislation that would loosen the FDA’s conflict of interest policies. The ostensible goal? To speed up the review of medical products. That legislation followed statements by FDA Commission Margaret Hamburg that the agency was having difficulties finding people without conflicts of interest to serve on its 55 committees.
The FDA, like every federal agency, is forbidden from appointing scientists with conflicts of interest to its technical advisory committees. However, the law allows exceptions. If the agency needs that particular person’s expertise, it can grant a waiver as long as it is disclosed to the public. It can also waive the conflict if it is considered too minor to actually affect a person’s judgment. Unfortunately, the law does not specify what is considered “de minimus.” $50,000? $5,000? $500?
Time for some personal disclosure: I spent five years during the 2000s as a public interest advocate lobbying to ban the use of scientists with conflicts of interest on federal advisory committees. It never passed Congress, but in 2007 the reauthorization of the Prescription Drug User Fee Act included a section that limited the total number of waivers allowed by the FDA.
My reasoning, like the many consumer organizations which backed a total ban on using conflicted scientists, was that there are plenty of non-conflicted experts at American universities, research institutes or in private practice who are just as knowledgeable as people who sign consulting deals with industry. Moreover, eliminating the whiff of impropriety that appointing scientists with conflicts of interest brings would maintain the public’s faith in the integrity of the process, even if the appointee swears up and down that is or she isn't biased by the relationship.
The fact the FDA didn’t even disclose through the waiver process that those ties existed was deeply troubling to many observers. “Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process,” Dr. Steven Nissen, a cardiologist at the Cleveland Clinic, told the Journal. The process is further undermined if the agency skirts its own rules to placate critics on Capitol Hill.
Senator Calls For Investigation of FDA "Pay To Play" Scandal
U.S. Sen. Joe Manchin (D-W.Va.) sent a letter to Margaret Hamburg, the commissioner of the U.S. Food and Drug Administration (FDA), informing her that he will be calling for a full investigation after news reports of "pay to play" allegations between the pharmaceutical industry and FDA officials overseeing safety regulations of painkiller medicine.
Earlier this week, The Washington Post reported that private companies paid as much as $25,000 to participate in FDA advisory panel discussions on federal regulations for prescription painkillers. If these allegations are accurate, this could be a direct conflict of interest, allowing pharmaceutical companies to have influence over the FDA’s decision-making process, particularly in regards to rescheduling hydrocodone combination drugs, a highly addictive painkiller.
“I am gravely concerned by the allegations of ‘pay to play’ between the FDA and pain medicine companies and am calling for a full investigation to see how deep this goes,” said Manchin. “If these allegations are true, they explain why it has taken the FDA almost a year to reach a decision to reschedule hydrocodone even after their own expert advisory panel recommended it. It is a shame that some of these companies were able to influence the FDA’s decision with a $25,000 contribution, while West Virginian families are destroyed by the addiction these pills cause.”
Manchin has led the fight to tighten restrictions on some of the most powerful, addictive narcotics on the market. Rescheduling hydrocodone painkillers, such as Vicodin and Lortab, from a Schedule III to a Schedule II controlled substance would accurately reflect the drugs’ high potential for addiction and abuse. The FDA’s own advisory board, consisting of leading scientists and experts in the field, has already completed a review and overwhelmingly voted to reschedule the drug. However, the agency has yet to act.
Whistle-Blower At Center of F.D.A. Scandal Is Shown The Door
As he often did, Dr. Robert C. Smith was hammering away at his bosses at the Food and Drug Administration in the most caustic of terms at a meeting to address his concerns about the approval of medical devices.
With seven fellow scientists seated behind him in support, Dr. Smith charged that managers “are not following the law, not following the science, not following F.D.A. core values,” according to notes of the 2008 session. He glared at a supervisor, who sat fuming in front of him.
Dr. Smith — radiologist, lawyer, litigant and the man now at the center of a spying scandal at the F.D.A. — is in some ways typical of that peculiar Washington phenomenon known as the whistle-blower: He pressed charges of government abuse, battled with his bosses, and ultimately was shown the door amid lawsuits and investigations.
But he took his role to an extreme, according to former colleagues, scorning negotiations, making enemies of critics and papering Washington with complaints, which helped sow chaos at the agency. One co-worker compared his efforts to “a mutiny.”
This month, F.D.A. officials came under fire from Congress after disclosures that they had begun a surveillance operation monitoring the e-mail of Dr. Smith and four other employees as they wrote to their lawyers, lawmakers and even President Obama. Dr. Smith’s scorched-earth tactics had so unnerved managers that they, too, resorted to extreme measures, and the monitors ended up producing a sort of enemies list of 21 agency critics, including Congressional officials, academics and journalists.
Some 80,000 pages of documents intercepted in the spy operation — many of them e-mails from Dr. Smith seeking help from scientists, politicians, reporters, academics and others — detail his campaign to expose what he claimed were harmful practices at the F.D.A. The documents, accidentally posted online by an F.D.A. contractor, reveal a four-year process of estrangement between Dr. Smith and his bosses.
At first, F.D.A. managers sought to appease him by restructuring his office, calling in mediators and pledging reforms. But he responded with more sweeping charges of wrongdoing, accusing agency officials and manufacturers of a criminal conspiracy to market unsafe devices. An outside consultant said his vitriolic attacks created a toxic workplace.
Dr. Smith stood to profit from his accusations: he and other disgruntled F.D.A. scientists had filed a lawsuit, kept secret under court seal by law, against manufacturers of imaging devices. After discovering the suit, F.D.A. officials began to suspect his motives. Those suspicions intensified when they learned that he had filed similar whistle-blowing lawsuits against two previous employers, Yale and Cornell.
The Brooklyn-born Dr. Smith, 52, who left the drug agency in 2010 and is now working as a radiologist at a private practice in Great Neck, N.Y., does not apologize for his aggressive style. “I’m not the kind of guy who ever in his life turns a blind eye to things,” he said in an interview.
His concerns about the effectiveness of certain imaging devices for detecting breast and colon cancer are shared by some medical experts. But potential allies were driven off by his abrasive style. “He got annoying, he got obstructive in nature,” said Dr. Carl D’Orsi, a mammography expert at Emory University who worked on an F.D.A. review panel and also served as a consultant for a manufacturer. Fellow employees went further, complaining to the consultant that Dr. Smith was “disruptive,” “adversarial” and “confrontational.”
Staff members for three Congressional committees that often criticize the F.D.A. reviewed Dr. Smith’s complaints and chose not to pursue them. The inspector general of the Department of Health and Human Services examined his claim that the agency was violating the law in reviewing medical devices and concluded that he was wrong.
Dr. Smith maintains that many imaging devices do not work as advertised by their manufacturers, produce many false positives and subject patients to needless rounds of potentially harmful radiological testing. Moreover, he says they waste enormous amounts of federal Medicare aid. Dr. Smith said that his sole goal in making his complaints was to protect Americans from harmful medical devices and that money was not a motive.
His concerns are now getting another look. The Office of Special Counsel, which investigates whistle-blower grievances, found in a confidential review this spring that Dr. Smith’s allegations raised a “substantial likelihood” of serious problems and required a full review. That has triggered an investigation by Kathleen Sebelius, the secretary of health and human services.
He charged in lawsuits that both universities fraudulently billed Medicare for improper radiological services. The fraud claims were ultimately thrown out, but Dr. Smith won settlements believed to total several hundred thousand dollars over retaliation he said he endured for complaining.
Within two years of his joining the F.D.A. as a radiologist in 2006, relations began to turn acidic there as well, as he challenged the approval of more than a dozen imaging devices.
Meticulously organized, he would arm himself with reams of scientific data, internal e-mails, notes of conversations, and citations from F.D.A. policy manuals and health statutes to make his case. Often, his language would be peppered with legal phrases honed from his days at Fordham Law School, where he completed a degree shortly before joining the drug agency.
He and eight colleagues accused agency managers of being too closely aligned with the medical manufacturers they regulated. They became known as “the F.D.A. 9,” and Dr. Smith was clearly their leader.
In the lawsuit he and six of the supporters brought in 2009, which was later unsealed, Dr. Smith’s group essentially accused the F.D.A. and medical manufacturers of conspiring to approve faulty devices. They brought the multibillion-dollar suit under the False Claims Act, which allows whistle-blowers to collect up to 30 percent of any damages. They withdrew it last year after the Justice Department declined to support the case.
A month before the lawsuit was filed, an F.D.A. biomedical engineer named Paul T. Hardy wrote an e-mail to the group signaling both his displeasure with the agency and the prospect of large financial damages.
“They are all corrupt,” Mr. Hardy said of supervisors. “Just need to sue the hell out of the agency ... get a couple cool mill and get out.” (He was fired in 2011.)
When Dr. Smith and other medical reviewers began demanding that manufacturers provide them with more clinical data about the safety of their products, F.D.A. managers deemed the requests excessive. “Things were getting out of hand,” said Larry Kessler, a former top F.D.A. official. “The reviewers were setting the bar far too high.”
Dr. Smith repeatedly approached lawmakers, sending out batches of late-night e-mails with huge files attached to demonstrate the F.D.A.’s dysfunction. Some Congressional staff members thought the F.D.A. might be punishing him for raising complaints. But others found his confrontational tactics so off-putting that they chose not to work with him.
Meanwhile, F.D.A. officials themselves resorted to more aggressive tactics as the battles wore on. Four times, the agency went to the inspector general to seek a criminal inquiry into allegations that Dr. Smith illegally leaked confidential information, had a financial conflict or improperly recorded conversations. Each time, the inspector general turned the agency down.
Despite the setbacks, the F.D.A. moved ahead with its surveillance program in April 2010.
“I never imagined in my wildest dreams that they were watching us second by second on our computers,” Dr. Smith said.
Three months after the surveillance began, a supervisor approached Dr. Smith in an F.D.A. library and told him he was being placed on administrative leave for improperly downloading documents and would be let go at the end of his two-year contract.
Dr. Smith sent his allies one last e-mail as an F.D.A. employee.
Captured in the surveillance files, it read: “Just to let everyone know, 30 minutes ago I was placed on paid administrative leave and escorted from the building. I am not kidding around. Talk to you later.”
* Parabens: A Cancer-Causing And DNA-Damaging Preservative Used In Food And Cosmetics
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