The Food and Drug Administration announced on Thursday that it would require the food industry to phase out the use of artificial trans fats in its products.
The FDA said it has made a preliminary determination that the primary source of trans fat – partially hydrogenated oils – is no longer “generally recognized as safe,” and that it plans to ban their use in the market. Some trans fat is naturally generated in meat and dairy products, and the ban will only apply to trans fat added to foods.
According to FDA Commissioner Margaret Hamburg, the decision could potentially prevent 20,000 heart attacks a year and 7,000 deaths.
Over the last decade, American consumption of trans fat has declined significantly. In 2006, the average citizen was consuming 4.6 grams of trans fat a day, while the number decreased to roughly one gram a day in 2012. Still, Hamburg said they “remain an area of significant public health concern,” according to NBC News.
Many companies began eliminating the use of trans fat when the FDA required them to list the ingredient on nutritional labels in 2006, but it can still be found in common products like frozen pizza, microwave popcorn, margarine, coffee creamer, and various desserts.
“The artery is still half clogged,” Dr. Thomas Frieden, the director of the Centers for Disease Control and Prevention, said to the New York Times. “This is about preventing people from being exposed to a harmful chemical that most of the time they didn’t even know was there.”
“It’s quite important,” he added, referring to the FDA’s new proposal. “It’s going to save a huge amount in health care costs and will mean fewer heart attacks.”
Numerous studies have shown that there is virtually no health benefit to consuming trans fat. It lowers the level of “good” cholesterol and raises levels of “bad” cholesterol, clogging the arteries and increasing the risk of heart attacks.
The FDA did not lay out a timetable for the ban. It will open its proposal to public comment for 60 days while it formulates a schedule that gives food manufacturers enough time to cooperate with the new rule.
“We want to do it in a way that doesn’t unduly disrupt markets,” Michael Taylor, the FDA’s deputy commissioner for foods, said to the Associated Press. At the same time, he said the food “industry has demonstrated that it is by and large feasible to do.”
Public health groups have welcomed the FDA’s proposal, which the agency has been collecting data for since 2009.
Should the FDA move forward with its plan, the United States will join other nations such as Denmark, Iceland, and Switzerland, in banning the ingredient.
Still, there are numerous other ingredients that have been outlawed in various countries while still being sold in the U.S. An, article by BuzzFeed over the summer noted that brominated vegetable oil, which has been linked to birth defects and organ damage, continues to be used in sports drinks and the popular soda Mountain Dew. It’s been banned in more than 100 countries.
Meanwhile, synthetic hormones rGBH and rBST, linked to cancer and infertility, continue to be given to cows and show up in dairy products that aren’t labeled otherwise. They’ve been banned in Japan, Canada, New Zealand, Australia, and the European Union.
Earlier this month, the FDA banned three out of the four brands of arsenic-laced animal feed that was being given to chickens, turkeys, and pigs. The decision came four years after the Center for Food Safety called on the FDA to remove the feed, but one brand remains on the market.
Despite repeated warnings from experts, the federal government under President Barack Obama has continued to allow farmers to pump livestock with antibiotics intended for humans, which has increased health risks for Americans.
A new study (pdf) from the Johns Hopkins Center for a Livable Future (JHCLF) blamed the lack of meaningful change in livestock-antibiotics policies on the agricultural and pharmaceutical industries, which have lobbied to block new laws and regulations from being adopted.
Members of Congress and officials with the Food and Drug Administration (FDA) have caved to industry pressures, even though evidence shows the overuse of antibiotics in livestock has made these drugs less effective in treating human infections.
Bob Martin, executive director of the JHCLF, told The Washington Post that FDA statistics reveal as much as 80% of the antibiotics sold in the U.S. are fed to cattle, pigs, chickens and other farm animals—a practice that reduces the efficacy of the drugs when it comes to fighting deadly infections in people.
Currently, about 23,000 patients die from antibiotic-resistant infections each year, according to the Centers for Disease Control and Prevention.
The Johns Hopkins study echoed the concerns of a 2008 report (pdf) on industry practices by a Pew Charitable Trusts commission of scientists that involved the Johns Hopkins Bloomberg School of Public Health. This earlier study also warned that the nation must back off on feeding antibiotics to animals.
The FDA has developed new guidelines that would require farms to stop using antibiotics specifically to bulk up food animals. But the rules would allow the drugs’ continued use for disease control. This latter provision is so loosely defined, Martin said, that there would be no practical change in the use of antibiotics.
“In a couple of areas, the Obama administration started off with good intentions. But when industry pushed back, even weaker rules were issued,” he told the Post. “We saw undue influence everywhere we turned.”
The new report was authored by a commission chaired by former Kansas governor John Carlin (D) and that included former U.S. agriculture secretary Dan Glickman, ranchers, and experts in public health and veterinary medicine.
The report’s message was echoed in a dire warning issued by Mary Wilson of the Harvard School of Public Health: “We will see common infections become fatal,” just as they were before the invention of antibiotics, she told the Post.
To Learn More:
Report: Feeding Antibiotics to Livestock is Bad for Humans, but Congress Won’t Stop It (by Melinda Henneberger, Washington Post)
Industrial Food Animal Production in America: Examining the Impact of the Pew Commission’s Priority Recommendations (John Hopkins Center for a Livable Future) (pdf)
FDA Quietly Ends Attempt to Regulate Antibiotics in Animal Feed (by Noel Brinkerhoff, AllGov)
80% of U.S. Antibiotics Go to Farm Animals (by Noel Brinkerhoff, AllGov)
Retired FDA investigator Patrick Stone (Katie Hayes Luke for ProPublica)
On the morning of May 3, 2010, three agents of the Food and Drug Administration descended upon the Houston office of Cetero Research, a firm that conducted research for drug companies worldwide.
Lead agent Patrick Stone, now retired from the FDA, had visited the Houston lab many times over the previous decade for routine inspections. This time was different. His team was there to investigate a former employee’s allegation that the company had tampered with records and manipulated test data.
When Stone explained the gravity of the inquiry to Chinna Pamidi, the testing facility’s president, the Cetero executive made a brief phone call. Moments later, employees rolled in eight flatbed carts, each double-stacked with file boxes. The documents represented five years of data from some 1,400 drug trials.
Pamidi bluntly acknowledged that much of the lab’s work was fraudulent, Stone said. “You got us,” Stone recalled him saying.
Based partly on records in the file boxes, the FDA eventually concluded that the lab’s violations were so “egregious” and pervasive that studies conducted there between April 2005 and August 2009 might be worthless.
The health threat was potentially serious: About 100 drugs, including sophisticated chemotherapy compounds and addictive prescription painkillers, had been approved for sale in the United States at least in part on the strength of Cetero Houston’s tainted tests. The vast majority, 81, were generic versions of brand-name drugs on which Cetero scientists had often run critical tests to determine whether the copies did, in fact, act the same in the body as the originals. For example, one of these generic drugs was ibuprofen, sold as gelatin capsules by one of the nation’s largest grocery-store chains for months before the FDA received assurance they were safe.
The rest were new medications that required so much research to win approval that the FDA says Cetero’s tests were rarely crucial.
Stone said he expected the FDA to move swiftly to compel new testing and to publicly warn patients and doctors.
Instead, the agency decided to handle the matter quietly, evaluating the medicines with virtually no public disclosure of what it had discovered. It pulled none of the drugs from the market, even temporarily, letting consumers take the ibuprofen and other medicines it no longer knew for sure were safe and effective. To this day, some drugs remain on the market despite the FDA having no additional scientific evidence to back up the safety and efficacy of these drugs.
By contrast, the FDA’s transatlantic counterpart, the European Medicines Agency, has pulled seven Cetero-tested medicines from the market.
The FDA also has moved slowly to shore up the science behind the drugs. Twice the FDA announced it was requiring drug makers to repeat, reanalyze or audit many of Cetero’s tests, and to submit their findings to the agency. Both times the agency set deadlines, yet it has allowed some companies to blow by them.
Today, six months after the last of those deadlines expired and almost three years after Cetero’s misconduct was discovered, the FDA has received the required submissions for just 53 drugs. The agency says most companies met the deadlines but acknowledged that “a few have not yet submitted new studies.”
Other companies, it said, have not submitted new research because they removed their drugs from the market altogether.
For its part, the FDA has finished its review of just 21 of the 53 submissions it has received, raising the possibility that patients are taking medications today that the agency might pull off the market tomorrow.
To this day, the agency refuses to disclose the names of the drugs it is reassessing, on the grounds that doing so would expose “confidential commercial information.” ProPublica managed to identify five drugs that used Cetero tests to help win FDA approval.
FDA officials defended the agency’s handling of the Cetero case as prudent and scientifically sound, noting that the agency has found no discrepancies between any original drug and its generic copy and no sign that any patients have been harmed.
“It is non-trivial to have to redo all this, to withdraw drugs, to alarm the public and the providers for a large range of drugs,” said Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research. “There are consequences. To repeat the studies requires human experimentation, and that is not totally without risk.”
Woodcock added that an agency risk assessment found the potential for harm from drugs tested by Cetero to be “quite low,” an assessment she said has been “confirmed” by the fact that no problems have been found in the drugs the agency has finished reviewing.
She declined to release the risk assessment or detail its design. A subsequent statement from the agency described the assessment as “fluid” and “ongoing.” The FDA also has not released its 21 completed reviews, which ProPublica has requested.
Some experts say that by withholding so much information in the Cetero case the FDA failed to meet its obligations to the public.
“If there are problems with the scientific studies, as there have been in this case, then the FDA’s review of those problems needs to be transparent,” said David Kessler, who headed the FDA from 1990 to 1997 and who is now a professor at the University of California at San Francisco. Putting its reviews in public view would let the medical community “understand the basis for the agency’s actions,” he said. “FDA may be right here, but if it wants public confidence, they should be transparent. Otherwise it’s just a black box.”
Another former senior FDA official, who spoke on condition of anonymity, also felt the FDA had moved too slowly and secretively. “They’re keeping it all in the dark. It’s not transparent at all,” he said.
By contrast, the European Medicines Agency has provided a public accounting of the science behind all the drugs it has reviewed. Its policy, the EMA said in response to questions, is to make public “all review procedures where the benefit-risk balance of a medicine is under scrutiny.”
Woodcock dismissed comparisons to the EMA. “Europe had a smaller handful of drugs,” she said, “and they may not have engaged in as extensive negotiation and investigations with the company as we did.”
She said the FDA would have disclosed more, including the names of drugs, had it believed there was a risk to public health. “We believe that this did not rise to the level where the public should be notified,” she said. “We felt it would result in misunderstanding and inappropriate actions.”
In a written response to Kessler’s comments, the FDA said, “We’ve been as transparent as possible given the legal protections surrounding an FDA investigation of this or any type. The issue is not a lack of transparency but rather the difficulty of explaining why the problems we identified at Cetero, which on their face would appear to be highly significant in terms of patient risk, fortunately were not.”
Still, the FDA’s secrecy has had other ramifications. Some of Cetero’s suspect research made its way unchallenged into the peer-reviewed scientific literature on which the medical community relies. In one case, a researcher and a journal editor told ProPublica they had no idea the Cetero tests had been called into doubt.
Cetero, in correspondence with the FDA, conceded misconduct. And in an interview, Cetero’s former attorney, Marc Scheineson, acknowledged that chemists at the Houston facility committed fraud but said the problem was limited to six people who had all been fired.
“There is still zero evidence that any of the test results…were wrong, inaccurate, or incorrect,” he said. Scheineson called the FDA’s actions “overkill” and said they led to the demise of Cetero and its successor company.
In 2012, the company filed for Chapter 11 bankruptcy and emerged with a new name, PRACS Institute. PRACS, in turn, filed for bankruptcy on March 22 of this year. A PRACS spokesperson said the company had closed the Houston facility in October 2012.
Pamidi, the Cetero executive who provided the carts of file boxes, declined to comment.
As for Stone, the former FDA investigator, he said he was disturbed by the agency’s decisions.
“They could have done more,” he said. “They should have done more.”
‘We Should Have Been Told’
Cross-checking U.S. and European public records, including regulatory filings, scientific studies and civil lawsuits, ProPublica was able to identify a few of the drugs that are on the U.S. market because of tests performed at Cetero’s Houston lab (see chart.) There is no evidence that patients have suffered harm from these drugs; the FDA says it has detected no increase in reports of side effects or lack of efficacy among Cetero-tested medications.
To be sure, just because a crucial study is deemed potentially unreliable does not mean that a drug is unsafe or ineffective. What it does mean is that the FDA’s scientific basis for approving that drug has been undermined.
The risks are real, academic experts say, particularly for drugs such as blood thinners and anti-seizure medications that must be given at very specific doses. And generic versions of drugs have been known to act differently from name-brand products (see accompanying story.)
There is no indication the generic ibuprofen gelatin capsules hurt anyone, but their case shows how the FDA left a drug on the market for months without confirmation that the drug was equivalent to the name brand.
The capsules were manufactured by Banner Pharmacaps and carried by Supervalu, a grocery company that operates or licenses more than 2,400 stores across the United States, including Albertson’s, Jewel-Osco, Shop ‘n Save, Save-A-Lot, and Shoppers Food & Pharmacy.
Cetero had performed a key analysis to show that the capsules were equivalent to other forms of the drug. Banner, the drug’s maker, said the FDA first alerted it to the problems at Cetero in August 2011. The FDA required drug companies to redo many of Cetero’s tests, but, a spokesperson for Banner wrote in an email, “We received no directive from FDA to recall or otherwise interrupt manufacture of the product.”
Banner said it repeated the tainted Cetero tests at a different research firm, and the FDA said it received the new data in January 2012 — leaving a gap of at least five months when the FDA knew the drug was on the market without a rock-solid scientific basis.
An FDA spokesperson wrote in an email that the agency found the new studies Banner submitted “acceptable” and told Banner it had no further questions.
A spokesperson for Supervalu told ProPublica it purchased the ibuprofen from a supplier, which has assured the grocery company that “there are no issues with the product.”
According to U.S. and European records, another one of the drugs approved based on research at Cetero’s troubled Houston lab was a chemotherapy drug known as Temodar for Injection.
Temodar was originally approved in 1999 as a capsule to fight an aggressive brain cancer, glioblastoma multiforme. Some patients, however, can’t tolerate taking the medication orally, so drug maker Schering-Plough decided to make an intravenous form of the drug.
To get Temodar for Injection approved, the FDA required what it called a “pivotal” test comparing the well-established capsule form of Temodar to the form injected directly into the bloodstream.
Cetero Houston conducted that test, comparing blood samples of patients who received the capsule to samples of those who got the injection to determine if the same amount of the drug was reaching the bloodstream. This test is crucial, particularly in the case of Temodar, where there was a question about the right dosing regimen of the injectable version. If too little drug gets into the blood, the cancer could continue to grow unabated. If too much gets in, the drug’s debilitating side effects could be even worse.
Cetero performed the test between September 2006 and October 2007, according to documents from the European Medicines Agency, and FDA records indicate that same test was used to win approval in the U.S.
In 2011, the FDA notified Merck & Co., which had acquired Schering-Plough, about the problems with Cetero’s testing. In April 2012, the FDA publicly announced that analyses done by Cetero during the time when it performed the Temodar work would have to be redone. But according to Merck spokesman Ronald Rogers, the FDA has not asked Merck for any additional analyses to replace the questionable study.
The FDA declined to answer specific questions about the Temodar case, saying to do so would reveal confidential commercial information. But Woodcock said that in some cases, drug manufacturers had submitted alternative test results to the FDA that satisfied the agency that no retesting was necessary for specific drugs.
The FDA never removed Temodar for Injection from the market. The European Medicines Agency also kept the injection form of the drug on the market, but the two agencies handled their decision in sharply different ways.
The EMA has publicly laid out evidence — including studies not performed by Cetero — for why it believes the benefits of the injection drug outweigh its risks. But in the United States, the FDA has kept silent. To this day, Temodar’s label — the single most important way the FDA communicates the risks and benefits of medication — still displays data from the dubious Cetero study. (The label of at least one other drug, a powerful pain reliever marketed as Lazanda, also still displays questionable Cetero data.)
Woodcock said the agency hadn’t required manufacturers to alter their labels because, despite any question about precise numerical precision, the FDA’s overall recommendation had not changed.
In a written response to questions, Merck said it “stands behind the data in the TEMODAR (temozolomide) label.” The company said it learned about “misconduct at a contract research organization (CRO) facility in Houston” from the FDA and that it cooperated with investigations by the FDA and its European counterpart. It said that Cetero had performed no other studies for Merck.
Even one of the researchers involved in evaluating injectable Temodar didn’t know that the FDA had flagged Cetero’s analysis as potentially unreliable until contacted by a reporter for this story.
Dr. Max Schwarz, an oncologist and clinical professor at Monash University in Melbourne, Australia, treated some brain-cancer patients with the experimental injectable form of Temodar and others with the capsule formulation. Blood from his patients was sent to Cetero’s Houston lab for analysis.
Schwarz said he still has confidence in the injectable form of the drug, but said that he was “taken aback” when a reporter told him that the FDA had raised questions about the analysis. “I think we should have been told,” he said.
Suspect research conducted by Cetero Houston was not only used to win FDA approval but was also submitted to peer-reviewed scientific journals. Aided by the FDA’s silence, those articles remain in the scientific literature with no indication that they might, in fact, be compromised. For example, based on Cetero’s work, an article in the journal Cancer Chemotherapy and Pharmacology purports to show that Temodar for Injection is equivalent to Temodar capsules.
Edward Sausville, co-editor-in-chief of the journal, said in an email that the first he heard that something might be wrong with the Cetero research was when a reporter contacted him for this story. He also said the publisher of the journal would conduct a “review of relevant records pertinent to this case.”
‘There’s Always Something Missing’
During his years of inspecting the Houston lab, the FDA’s Stone said he often had the sense that something wasn’t right. When he went to other contract research firms and asked for data on a trial, they generally produced an overwhelming amount of paper: records of failed tests, meticulous explanations of how the chemists had made adjustments, and more.
Cetero’s records, by contrast, showed very clean, error-free procedures. As Stone and his colleagues dug through the data, though, they often found gaps. When pressed, Cetero officials would often produce additional data — data that ought to have been in the files originally handed over to the FDA.
Stone said, “We should have looked back and said, ‘Wait a minute, there’s always something missing from the studies from here. Why?’”
One reason, the FDA would determine, was that Cetero’s chemists were taking shortcuts and other actions prohibited by the FDA’s Good Laboratory Practice guidelines, which set out such matters as how records must be kept and how tests must be performed.
Stone and his FDA colleagues might never have realized Cetero was engaging in misconduct if a whistleblower hadn’t stepped forward.
Cashton J. Briscoe operated a liquid chromatography-tandem mass spectrometry device, or “mass spec,” a sensitive machine that measures the concentration of a drug in the blood.
He took blood samples prepared by Cetero chemists and used mass specs to perform “runs” — tests to see how much of a drug is in patients’ blood — that must always be performed with control samples. Often those controls show readings that are clearly wrong, and chemists have to abort runs, document the failure, recalibrate the machines, and redo the whole process.
But Cetero paid its Houston chemists based on how many runs they completed in a day. Some chemists doubled or even tripled their income by squeezing in extra tests, according to time sheets entered as evidence in a lawsuit filed in U.S. District Court in Houston by six chemists seeking overtime payments. Briscoe thought several chemists were cutting corners — by using the control-sample readings from one run in other runs, for example.
Attorney Scheineson, who represented Cetero during the FDA’s investigation, acknowledged that the Houston lab’s compensation system was “crappy” and that a handful of “dishonest” chemists at the Houston facility committed fraud.
In April 2009, Briscoe blew the whistle in a letter to the company written by his lawyer, reporting that “many of the chemists were manipulating and falsifying data.” Soon thereafter, Briscoe told the company that he had documented the misconduct. According to Stone and documents reviewed by ProPublica, Briscoe had photographic evidence that mass spec operators had switched the quality control samples between different runs; before-and-after copies of documents with the dates and other material changed; and information about a shadow computer filing system, where data from failed runs could be stored out of sight of FDA inspectors.
On June 5, apparently frustrated with Cetero’s response, Briscoe went a step further and called the FDA’s Dallas office. He agreed to meet Stone the following Monday, but never showed. Stone called him, as did other FDA officials, but Briscoe had changed his mind and clammed up.
Still, Stone’s brief phone conversation with Briscoe reminded the agent of all those suspiciously clean records he had seen at Cetero over the years. “Now that you have a bigger picture,” Stone recalled, “you’re like, ‘Oh, some of this stuff is cooked.’”
Two days after Stone’s aborted meeting with Briscoe, Cetero informed the FDA that an employee had made allegations of misconduct and that the company had hired an outside auditor to review five years’ worth of data. That led to months of back-and-forth between the agency and Cetero that culminated when Stone and his inspectors arrived in Houston in May 2010.
Two teams of FDA investigators eventually confirmed Briscoe’s main allegations and cited the company for falsifying records and other violations of Good Laboratory Practice. The net effect of the misconduct was far-reaching, agency officials wrote in a July 2011 letter:
“The pervasiveness and egregious nature of the violative practices by your firm has led FDA to have significant concerns that the bioequivalence and bioavailability data generated at the Cetero Houston facility from April 1, 2005, to June 15, 2010 … are unreliable.”
Bioequivalence studies measure whether a generic drug acts the same in the body as the name-brand drug; bioavailability studies measure how much drug gets into a patient’s system.
The FDA’s next step was to try to determine which drugs were implicated — information the agency couldn’t glean from its own records.
“We couldn’t really tell — because most of the applications we get are in paper — which studies were actually linked to the key studies in an application without asking the application holders,” the FDA’s Woodcock said. “So we asked the application holders,” meaning the drug manufacturers.
In the interim, the FDA continued to investigate processes and procedures at Cetero.
“We put their operations under a microscope,” said Woodcock. A team of clinical pharmacologists, statisticians and IT experts conducted a risk analysis of the problems at Cetero, she said, and they “concluded that the risk of a misleading result was very low given how the studies were done, how the data were captured and so forth.”
In April 2012, nearly three years after Briscoe first alerted the FDA to problems at Cetero, and nearly two years after Cetero handed over its documentation to inspectors, the FDA entered into a final agreement with the company. Drug makers would need to redo tests conducted at the company’s Houston facility between April 1, 2005 and Feb. 28, 2008, if those studies had been part of a drug application submitted to the FDA. If stored blood samples were still usable, they could be reanalyzed. If not, the entire study would need to be repeated, the FDA said. The agency set a deadline of six months.
Cetero tests done between March 1, 2008 and Aug. 31, 2009 would be accepted only if they were accompanied by an independent data integrity audit.
Analyses done after Sept. 1, 2009 would not require retesting. The FDA said that Cetero had issued a written directive on Sept. 1, 2009, ordering one kind of misconduct to stop, which was why it did not require any action on Cetero Houston studies after that date. According to public documents, however, the agency’s inspectors “found continued deficiencies” that persisted into December 2010.
In response to questions, the FDA said the problem period “was subsequently narrowed as more information regarding Cetero’s practices became available.”
A year after concluding its final agreement with Cetero, the FDA’s review is still not finished. “Without the process being public it’s hard to know, but it seems that this has been going on for too long,” said Kessler, the former FDA chief.
“The process has been long,” the FDA said, “because of the number of products involved and our wish to be thorough and accurate in both our requests for and our review of the data.”
Cetero’s attorney Scheineson said the FDA scaled back its requirements because it finally talked with company officials. He noted that Cetero had tried repeatedly to talk with the FDA before the agency issued its strongly worded July 2011 letter, and that more than 1,000 employees have since lost their jobs.
“If you would get an honest assessment from the leaders of the agency,” he said, “I think in retrospect they would have argued that this was overkill here and that they should have had input from the company before essentially going public with that death sentence.”
“I’m not sure what is meant by ‘death sentence,’” an FDA spokesperson wrote in response, “but our first priority was and is patient safety and we proceeded to conduct the investigation toward that objective.”
‘Should I Be Proud of This?’
The FDA’s Stone draws little satisfaction from unraveling the problems at Cetero.
There are thousands of bioequivalence studies done every year, he pointed out, with each study generating thousands of pages of paper records. “Do you really think we’re going to look at 100 percent of them? We’re going to look at maybe 5 percent if we’re lucky,” he said. “Sometimes 1 percent.”
Still, given how often he and other FDA teams had inspected the Houston lab, he thinks regulators should have spotted Cetero’s misconduct sooner.
“In hindsight I look back and I’m like, ‘Wow, should I be proud of this?’” he said. “It’s cool that I was part of it, but it’s crap that we didn’t catch it five years ago. How could we let this go so long?”
Research assistance for this story was contributed by Nick Stockton, Christine Kelly, Lily Newman, Joss Fong and Sarah Jacoby of the Science, Health, and Environmental Reporting Program at NYU.
WASHINGTON – Dairy industry groups have asked the Food and Drug Administration to be able to put artificial sweeteners in milk, and not change the label, claiming that it is so consumers can “more easily identify its overall nutritional value”.
The Food and Drug Administration is asking for data related to those sweeteners.
The International Dairy Foods Association (IDFA) and the National Milk Producers Federation (NMPF) filed a petition in 2009 requesting that the FDA amend its standard of identity for milk.
The petition asked the agency to allow the use of “any safe and suitable” sweetener for milk and asked to amend the standards of identity for 17 other milk and cream products.
Those products include sweetened condensed milk, whipping cream, yogurt and eggnog, which the groups say should be allowed to have “safe and suitable” sweeteners.
The groups request that the FDA “allow optional characterizing flavoring ingredients used in milk (e.g. chocolate flavoring added to milk) to be sweetened with any safe and suitable sweetener – including non-nutritive sweeteners such as aspartame.”
FDA regulations currently only allow milk products to contain “nutritive sweeteners” (those with calories) which the agency generally recognizes as safe.
The groups say the amendments “would promote more healthful eating practices and reduce childhood obesity by providing for lower-calorie flavored milk products.”
“They state that lower-calorie flavored milk would particularly benefit school children who, according to IDFA and NMPF, are more inclined to drink flavored milk than unflavored milk at school,” the FDA wrote in its notice.
The groups also say they would help with programs that aim to improve nutrition in school meals and argue that the proposed amendments would promote “honesty and fair dealing in the marketplace,” the FDA wrote.
The year 1999 was a good one for the drug company Merck. In its 64 page annual report, it predicted that the arthritis medicine Vioxx (“Our Biggest, Fastest, and Best Launch Ever!”) would also prevent Alzheimer’s disease and colon cancer. It announced it was seeking approval to market the asthma drug Singulair to two-year-olds. And it forecast that 40 million women would take its new osteoporosis drug, Fosamax, as Merck continued to “help educate both doctors and patients” about the bone disease.
It turned out Merck spoke too soon. Vioxx was withdrawn in 2004 for doubling stroke and heart attacks in long-term users; Singulair now carries FDA warnings about “neuropsychiatric events” and Fosamax is suspected of doubling the risk of esophageal cancer, causing bone fractures instead of preventing them and causing heart problems, intractable pain and jawbone death. Oops!
There’s plenty of ka-ching in selling “strong bones” products for the same reason there was plenty of ka-ching in selling “hormone replacement” products: one-half the population is female, and no one wants to look old. Of course, “avoiding hot ﬂashes” really means “still looking hot” in hormone marketing terminology, and “avoiding fractures” really means “still looking hot” in bone product marketing lingo. That’s why attractive women like Meredith Vieira from the Today show and former Charlie’s Angel Cheryl Ladd and actress Sally Field push bone drugs, just as model Lauren Hutton pushed hormone replacement therapy.
To cash in on Fosamax, the first in the bisphosphonate bone drug class, Merck decided to market the dangers of osteoporosis “far beyond ailing old ladies.” It hired researcher Jeremy Allen to whip up fears of “osteopenia,” the risk of osteoporosis, as a health epidemic to sell bone drugs and planted bone scan machines in medical offices across the country, says National Public Radio. Allen created the faux “Bone Measurement Institute” which also maneuvered Medicare reimbursement for the scans. By 1999, there were 10,000 bone scan machines in medical offices, said the Associated Press, when there had been only 750 before Fosamax.
Like its trouble-laden drug Vioxx, Merck’s Fosamax ﬂew out of the FDA. It received only a six month review before its 1995 FDA approval. (The government also helped its promotion with the HHS secretary herself, Donna Shalala, participating in a 1998 rally kicking off free bone density screenings to be offered in 100 cities.)
But the wheels soon came ﬂying off the bone drug. Patients experienced esophageal “irritation” and the warning to stay upright for one full hour after taking Fosamax, eating or drinking nothing was added after approval. One woman who took Fosamax but remained upright for only 30 minutes, not 60, had to be admitted to the Mayo Clinic with “severe ulcerative esophagitis affecting the entire length of the esophagus” and had to be fed intravenously, according to the New England Journal of Medicine.
Next, dentists and oral surgeons discovered after simple tooth extractions and other in-ofﬁce dental work, the jawbone tissue of patients on bisphosphonates would sometimes not heal but become necrotic and die — a condition called osteonecrosis of the jaw(ONJ), The necrotic condition did not take long to manifest “even short-term oral use of alendronate [Fosamax] led to ONJ in a subset of patients” — wrote a dental journal, but it somehow slipped through Fosamax’s two, three-year clinical trials on which its FDA approval was based. Doctors, dentists, and pharmacists were enraged at what looked like deliberate obfuscation by Merck.
And there were second, third and fourth opinions about Fosamax! According to an FDA epidemiologist writing in New England Journal of Medicine in 2009 there were 23 incidences of Fosamax-associated esophageal cancer in the US and eight deaths and 27 incidences of cancer in Europe and Japan and six deaths.
Next reports in medical journals linked bisphosphonates to the risk of developing atrial ﬁbrillation, or a chronically irregular heartbeat and to severe bone, joint or muscle pain. “In the most serious cases, the pain was so severe that patients could not continue their normal activities,” wrote the FDA in a press release. “Some patients have complete relief of symptoms after they stop taking the drug, while others have reported slow or incomplete resolution.” Clearly, the FDA was trying hard to avoid the word irreversible.
Finally, in a development that suggests tremendous medical ineptitude if not duplicity, bisphosphonates were found to sometimes cause the very fractures they were supposed to prevent. The thigh bones of patients on bisphosphonates have “simply snapped while they were walking or standing,” after “weeks or months of unexplained aching,” reported the New York Times in an article called “Drugs to Build Bones May Weaken Them.”
It should be embarrassing to the medical establishment that a prominent drug company and the FDA “discovered” severe side effects after years of patient use and that bone scans are still merchandised though they are of no value to 90 percent of women, according to the New England Journal of Medicine. It should be further embarrassing that Merck was allowed to make $3 billion a year off a drug that many say would not have been approved had clinical trials lasted longer. Its patent expired in 2008.
Now Merck is about to launch a new drug for osteoporosis called odanacatib which has already intrigued the money men on Wall Street. “Odanacatib may be a viable alternative for patients who need continued therapy and who want benefits beyond what they received from bisphosphonates,” a senior Merck research executive told Reuters without a hint of irony.
Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: firstname.lastname@example.org.
- New Study Links Fosamax to Esophageal Cancer (prweb.com)
- New Study Links Fosamax to Vision Problems Risk (prweb.com)
- Intramedullary Nailing Surgery Is Successful Treatment For Patients With Femur Fractures From Use Of Fosamax Or Other Bisphosphonates (drug-injury.com)
- Alendronate Oral May Posses Bad Side Effects (businesslawdaily.net)
Barack Obama’s administration has launched attacks unparalleled since the McCarthy years on those who blow the whistle against corruption inside the federal government.
Obama has already charged more whistleblowers under the Espionage Act than all previous administrations combined (as reflected in the list below.) Peter van Buren, a career foreign affairs officer at the Department of Department of State claims his job was threathened after writing, We Meant Well: How I Helped Lose the Battle for the Hearts and Minds of the Iraqi People. Van Buren, who became disillusioned by waste and hypocrisy while serving in Iraq, says “The number of cases in play [against whistleblowers] suggests an organized strategy to deprive Americans of knowledge of the more disreputable things that their government does. How it plays out in court and elsewhere will significantly affect our democracy.”
Van Buren points out that the pre-World War 1 Espionage Act has been used against “labor leaders and radicals like Eugene V. Debs, Bill Haywood, Philip Randolph, Victor Berger, John Reed, Max Eastman, and Emma Goldman. Debs, a union leader and socialist candidate for the presidency, was sentenced to 10 years in jail for a speech attacking the Espionage Act itself. The Nixon administration infamously (and unsuccessfully) invoked the Act to bar the New York Times from continuing to publish the classified Pentagon Papers.” But no other administration has used this legislation as liberally as President Obama who has authorized more drone attacks than any other American president.
Van Buren was writing on the blog Tom.Dispatch.com of Tom Engelhardt, a teaching fellow at the Graduate School of Journalism at the University of California. Engelhardt in turn observes: “One thing is obvious. No one ever joins the government in order to be a whistleblower or leaker.Whistleblowers are created, not born,” speaking words that resonate with my experience as a whistleblower. Van Buren notes: “It is perhaps typical of whistleblowers and leakers that something they are privy to simply pushes them over the edge.” In my case it was the realization that government was failing to act against a U.S. multinational whose mining practices were leading to the injury and deaths of South African vanadium miners.
I continue to speak out against injustice, but it certainly has not made my life easier. Each week I get mails to my Facebook site from those who are whistleblowers or are close to whistleblowers. This week’s example is typical: “I know you don’t know me and I am taking a HUGE chance by writing you, but I have to at least try. My parents are going through some of the same things you went through at the EPA. Both top-level executives at federal agencies they have been retaliated harshly against. NO ONE seems to hear us. I’m begging for your help. Please help us… These agencies are corrupt and we are still on the bus fighting like Rosa.”
There is little I can do other than direct them to the National Whistleblower Center, give the names of lawyers and share a little human empathy. But there is no doubt that under this administration there is a concerted attack against those who dare to expose corruption in government or corporations.
Recently four employees of the Air Force Mortuary in Dover, Delaware, revealed that the Dover Air Force Base mortuary had lost and sawed off body parts and mishandled other remains of America’s war dead. Retaliation against them included firings, the placing of employees on indefinite administrative leave, and the imposition of five-day suspensions. Special Counsel Carolyn Lerner has accused the Air Force of deflecting blame — and a mortuary official of lying and obstructing the probe by firing one of the workers who blew the whistle. What remains to be seen is whether Lerner, an Obama political appointee, will distinguish herself from her disgraced predecessor by seriously investigating corruption under this administration.
At present six whistleblowers are suing the Food and Drug Administration for electronically spying on them when they tried to alert Congress about misconduct at the agency. This is the agency tasked with overseeing public health, food safety, medicines and medical devices. Senator Charles E. Grassley (R-Iowa) launched an investigation in response to a lawsuit filed by six FDA whistleblowers and documents released by the National Whistleblowers Center that show the FDA targeted whistleblowers for special monitoring and intercepted personal communications to Congress, including emails to Senator Grassley’s staff. Senator Grassley, the Ranking Member of the Senate Judiciary Committee asked FDA Commissioner Margaret Hamburg whether or not whistleblowers were singled out for special monitoring based on a letter they wrote to President-Elect Obama’s Transition Team.
We are waiting to see the Army’s reaction to whistleblower Lieutenant Colonel Daniel Davis, who documented in the Armed Forces Journal that senior leaders of the Department of Defense intentionally and consistently misled the American people and Congress about success in the Afghan War.
Those charged under the Espionage Act include:
- Former CIA officer John Kiriakou charged on January 23 for disclosing classified information to journalists about the waterboarding of al-Qaeda suspects. The CIA also found an excuse to fire his wife, also employed by the Agency, while she was on maternity leave.
- Thomas Drake an employee of the National Security Agency revealed that it spent $1.2 billion on a contract for a data collection program called Trailblazer when the work could have been done in-house for $3 million. Drake’s home was raided at gunpoint and the agency forced him out of his job. He now works at an Apple Store. His attorney told Anti-war.com: “Too often, whistleblowers end up broken, blacklisted, and bankrupted.”
- Whistleblower Pvt. Bradley Manning, accused of leaking Army and State Department documents to the website WikiLeaks, spent more than a year in a U.S. Marine prison and was denied the chance even to appear in court to defend himself until almost two years after his arrest.
- Former chief military prosecutor at Guantanamo Morris Davis lost his career as a researcher at the Library of Congress for writing a critical op-ed for the Wall Street Journal and a letter to the editor at the Washington Post on double standards at the infamous prison.
- Robert MacClean was charged for blowing the whistle on the Transportation Security Administration.
Van Buren notes in his piece for Tom.Dispatch.Com “My travel vouchers from as far back as the law allows have come under “routine” re-examination. My Internet activity is the subject of daily reports. My credit reports have been examined for who knows what. Department friends who email me on topical issues have been questioned by agents of Diplomatic Security, the State Department’s internal police. My Freedom of Information Act request for documents to help defend myself and force State to explain its actions has been buried.”
And then we read investigative reports in the Washington Post, as an example, of 33 members of Congress that have steered more than $300 million in earmarks and other spending provisions to dozens of public projects that are next to or within about two miles of the lawmakers’ own property. We have yet to hear of action against them.
Freedom of the press and freedom of expression are American constitutional bulwarks. These important elements of the constitution provide protection for truth-tellers as the last defense against tyranny. It is a shame that a legacy of the first African American president is heightened repression against whistleblowers.
See Marsha on C-Span Book/TV at: www.marshacoleman-adebayo.org.
Dr. Marsha Coleman-Adebayo is the author of No FEAR: A Whistleblowers Triumph over Corruption and Retaliation at the EPA is available through amazon.com and the National Whistleblower Center. Dr. Coleman-Adebayo worked at the EPA for 18 years and blew the whistle on a US multinational corporation that endangered vanadium mine workers. Marsha’s successful lawsuit lead to the introduction and passage of the first civil rights and whistleblower law of the 21st century: the Notification of Federal Employees Anti-discrimination and Retaliation Act of 2002 (No FEAR.)
- Whistleblower Lawsuit Puts Spotlight On FDA Technical Reviews (news.sciencemag.org)
- Inside President Obama’s War On The Fast & Furious Whistleblowers (forbes.com)
- Scientists suing the FDA after covert surveillance (newscientist.com)
By ISMAEL HOSSEIN-ZADEH | January 28, 2011
President Reagan did not make any bones about his intention to reverse the New Deal economics when he set out to promote the Neoliberal economics. Likewise, President George W. Bush did not conceal his agenda of aggressive, unilateral militarism abroad and curtailment of civil liberties at home.
There is a major similarity and a key difference between these two presidents, on the one hand, and President Obama, on the other. The similarity lies in the fact that, like his predecessor, President Obama faithfully, and indeed vigorously, carries out both the Neoliberal and militaristic policies he inherited.
The difference is that while Reagan and Bush were, more or less, truthful to their constituents, President Obama is not: while catering to the powerful interests vested in finance and military capitals, he pretends to be an agent of “change” and a source of “hope” for the masses.
There has been a wide-ranging consensus that the excessive financial/economic de-regulations that started in the late 1970s and early 1980s played a critical role in both the financial bubble that imploded in 2007-2008 and the continuing persistence of the chronic recession, especially in the labor and housing markets.
Prior to his recent U-turn on the regulation-deregulation issue, President Obama shared this near unanimous view of the destructive role of the excessive deregulation of the past several decades and, indeed, strongly supported the need to bolster regulation: “It’s time to get serious about regulatory oversight,” Mr. Obama argued as the Democratic nominee for President; and again, “…this crisis has reminded us that without a watchful eye, the market can spin out of control,” as he stated in his inaugural speech.
Expressions of such pro-regulation sentiments were part of his earlier promises of “hope” and “change” in a new direction. Back then, that is, before showing his Neoliberal hand, the majority of the American people believed him—the middle, lower-middle, poor and working people who were tired of three decades of steady losses of economic security were desperately willing to believe a charismatic leader who peddled hope and change in their favor.
Recently, however, the president seems to have had a change of heart, or perhaps an epiphany, regarding the regulation-deregulation debate: he now argues that protracted recession and persistent high levels of unemployment are not due to excessive deregulation but to overregulation! Accordingly, he issued an executive order on 18 January 2011 that requires a comprehensive review of all existing government regulations. On the same day, the president wrote an op-ed piece for the Wall Street Journal in which he argued that the executive order was necessary in order “to remove outdated regulations that stifle job creation and make our economy less competitive.” The president further argued that “Sometimes, those [regulatory] rules have gotten out of balance, placing unreasonable burdens on business—burdens that have stifled innovation and have had a chilling effect on growth and jobs. . . . As the executive order I am signing makes clear, we are seeking more affordable, less intrusive means to achieve the same ends—giving careful consideration to benefits and costs.”
Stripped from its Orwellian language, this “cost-benefit” approach to health, safety and environmental standards is clearly the familiar Neoliberal rhetoric that is designed to help big business and their lobbies that have been working feverishly to stifle the widespread pro-regulation voices that have grown louder since the 2007-08 financial melt-down.
Indeed, the president’s recent agenda of further deregulation has already born fruits for big business. The Wall Street Journal reported on 20 January 2011:
“A day after President Barack Obama ordered the government to get rid of burdensome rules, two federal agencies backed down from proposals that had drawn jeers from businesses. . . . The Labor Department said it was withdrawing a proposal on noise in the workplace that could have forced manufacturers to install noise-reducing equipment. And the Food and Drug Administration retreated from plans to tighten rules on medical-device approvals, postponing a proposal that would have given the FDA power to order additional post-market studies of devices. . . . Industry leaders praised the moves, while consumer advocates expressed disappointment. . . . ‘This is a very positive step forward,’ said Bill Hawkins, chief executive of medical-devices heavyweight Medtronic Inc.”
How is the president’s sharp turnaround on the regulation-deregulation debate to be explained? What “outdated deregulation” is he talking about? How could deregulation, which is widely believed to have been the problem, also be the solution? Why this sudden U-turn?
The change in the president’s view from the need for regulation to that of further deregulation can be explained on a number of planes.
On a narrow, personal and (perhaps) simplistic level, it can be argued that the president’s about-face on the issue of deregulation should not really be surprising; the turnaround represents quintessential Obama: spineless and/or unscrupulous, if you are a critic of the president; pragmatic and/or complex, if you are an apologist or defender of him.
There are also, of course, re-election considerations here. And here it seems that the president’s team is pinning his chances for re-election on big business and big media; confident that once he is able to win their hearts and minds, they will, in turn, be able to manipulate the public to vote for him—just as they did in the 2008 election.
On a deeper (but still personal) level, that is, on a philosophical or ideological level, it can be argued that the president has always been a Neoliberal thinker, albeit a stealth Neoliberal, who is coming out of the closet, so to speak, carefully and gradually. Evidence of his being ideologically more a partisan of Neoliberal than New Deal economics is overwhelming (see, for example, Pam Martin and Alan Nasser).
It is necessary to point out that although the stealth Neoliberal president has been taking baby steps out of the closet, he would always stay by the entrance: as long as there is no popular anger or pressure against his Neoliberal policies, he would stay on the outside; at the first signs of a threatening pressure from the grassroots, however, he would crawl back inside the closet, and begin preaching populism or uttering ineffectual, benign corporate-bashing rhetoric. This is his mission and his political forte – a master demagogue. And this is why the politico-economic establishment promoted him to presidency as they found him the most serviceable presidential candidate. None of his presidential rivals could have served the tycoons of the finance world and the kings of Wall Street as well as he has.
On a more fundamental level, President Obama’s reversal of his view from the need for rigorous regulation to the need for further deregulation, and his economic policies in general, show that while the politics and personalities of a president ought not be ignored, presidential economic policies cannot be explained by purely personality issues such as a failure of nerve, conviction, or ideas. The more crucial determinants of national economic policies are often submerged: the balance of social forces and the dominant economic interests that shape such policies from behind the scene. Stabilization, restructuring or regulatory policies are often subtle products of the outcome of the class struggle.
Thus, when the balance of social forces is tilted in favor of the rich and powerful, crisis-management economic policies would be crafted at the expense of the working people and other grassroots. In other words, as long as the costly consequences of the brutal Neoliberal restructuring policies (in terms of job losses, economic insecurity, and environmental degradation) are tolerated, business and government leaders, Republican or Democrat, would not hesitate to put into effect draconian measures to restore conditions of capitalist profitability at the expense of the impoverishment of the public.
On the other hand, when crisis periods give rise to severe resistance from the people to cuts in social spending, such crisis-management policy measures could also benefit the public. A comparison/contrast of policy responses to major economic crises in the United States clearly supports this point. Economic historians have identified four major economic crises in the past 150 years or so: The First Great Depression (1873-97), The Second Great Depression (1929-37), the long recession of 1973-83 (also known as the stagflation of the 1970s), and the current long recession that started in 2007-08.
Since there was no compelling grassroots pressure in response to either the First Great Depression of 1873-97 or the long recession of the 1970s, crisis management policies in both instances were decisively of the Neoliberal, supply-side type: suppression of trade unions and curtailment of wages and benefits; promotion of mergers, concentrated industries and big business; extensive de-regulations and generous corporate welfare plans; in short, huge transfers of income from labor to capital. Likewise, a glaring lack of grassroots resistance in the face of the current long recession has allowed the ruling kleptocracy (both in the US and beyond) to adopt similarly brutal austerity policies that are gradually reviving financial/corporate profitability at the expense of the poor and working people.
By contrast, in response to the Great Depression of the 1930s workers and other popular forces achieved employment and income security as a result of a sustained pressure from “below.”
The contrast between these two entirely different types of restructuring strategies shows that, as Mark Vorpahl, a union steward, recently put it, “Working people and the unemployed cannot rely on the politicians to get the change we need. We can only rely on our own collective strength. That is, we need to organize and mobilize as a united, massive, powerful force that cannot be ignored by those more intent to do Wall Street’s bidding.” Only the threat of revolution can force people-friendly reform on the ruling kleptocracy.
Ismael Hossein-zadeh, author of The Political Economy of U.S. Militarism (Palgrave-Macmillan 2007), teaches economics at Drake University, Des Moines, Iowa.