FDA
odd to divide food inspection; one agency gets 1/4 of $ but 3/4 of work; marion nestle kpfa 1/13/13
taylor head michael ex of monsanto
s 510 farm bill
biotech regs? GMO?
no merri
SEE DOGE
see henry miller ex-fda, always to dereg?
see Hahn trump guy
===
-=-=
explosive diahhrea crytospora? usda?
-=-=
gil bk
milo 2016 PT rnc speech; sri head fda jim o'neill met djt to discuss
-=-=
head lawyer
us-fda-names-sean-keveney-chief-counsel-2025-08-04 doj civil rights?
===
AN 5 26
President Donald Trump’s choice to lead America’s Food and Drug Administration (FDA) is Dr. Marty Makary, a surgeon who gained international attention during the COVID-19 pandemic for his opposition to vaccine mandates. On paper, Makary seems like a great choice for the job, but a conservative newspaper is reporting “soap opera”-level drama associated with his tenure.
“Has any Trump administration official caused more political headaches for the president than Marty Makary?” wrote Allysia Finley of The Wall Street Journal on Sunday. “His Food and Drug Administration has turned into a soap opera, with real lives hanging in the balance.”
To illustrate this point, Finley described how "in public interviews, [Makary] boasts about accelerating access to gene therapies and rare-disease drugs, even as he and his deputies block them." Describing Makary as “slicker than a pharmaceutical salesman,” the Journal reporter observed that “my sources say that patience with Dr. Makary is wearing thin among Republicans in Congress and White House officials."
Since taking office, Makary has rejected rare-disease and cancer drugs, a gene therapy for Huntington’s Disease and various other medicines that had demonstrably improved or even saved lives. He has also been accused of allowing conflicts of interest to override his detached clinical judgment.
“Members of Congress are also investigating whistleblower complaints of retaliation by agency leadership against FDA staff who have recommended approvals of drugs with which Dr. Makary and his left-hand man, Vinay Prasad, disagreed,” Finley reported. “Dr. Prasad is a Bernie Sanders acolyte whom the commissioner tapped to lead the FDA’s biologics and gene-therapy division.”
Finley also quoted a Republican, Sen. Ron Johnson of Wisconsin, as saying that “the stories are so outrageous. It just appears that they're looking for excuses to say no." Johnson also reported rumors that the FDA has kept a “blacklist” of companies that “make too much noise.”
Finely concluded, "It's time for Mr. Trump to pull the plug on the Makary show."
Although not mentioned in her editorial, the FDA is also under fire for seeming to pull back from its responsibilities to protect food. Under Makary’s tenure, the FDA announced it would no longer engage in routine food inspections, describing that job as superfluous and instead arguing federal inspectors should offload all of those responsibilities to local authorities.
"There's so much work to go around. And us duplicating their work just doesn't make sense," a former FDA official explained to CBS News at the time.
The FDA has also been criticized for incorrectly saying that COVID vaccines have caused child deaths, a policy that Dr. Celine Grounder of KFF Health News denounced for allegedly endangering the public.
“What is unfolding inside the FDA is not a narrow dispute over covid vaccines,” Grounder argued. “It is an attempt, according to critics and vaccine scientists, to rewrite the rules governing the entire U.S. vaccine system — how risks are weighed, how benefits are proved, and how quickly lifesaving shots reach the public.”
Grounder concluded, “Former agency leaders warn that if these changes take hold, the consequences could be lasting: fewer vaccines, slower updates, weakened public trust, and more preventable outbreaks.”
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GGL 12 25 RFK FDA
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AN 12 25
After President Donald Trump returned to the White House on January 20, his administration aggressively downsized a long list of federal government agencies with the help of the Department of Government Efficiency (DOGE) and its then-leader, Tesla/SpaceX/X.com head Elon Musk. Trump claimed that his goal was reducing "waste, fraud and abuse," but critics of the Trump Administration/DOGE cuts argued that they were robbing the agencies of crucial personnel they need in order to function properly — from the U.S. Social Security Administration (SSA) to the National Weather Service (NWS) to the Internal Revenue Service (IRS).
Another agency that has been suffering chaos during Trump's second presidency is the U.S. Food and Drug Administration (FDA).
In an article published on December 4, Axios' Pete Sullivan describes the FDA departures that are contributing to instability at the agency.
"Another abrupt departure of a high-ranking Food and Drug Administration official is raising alarm about a brain drain that could mean new drugs take longer to reach the public," Sullivan reports. "Why it matters: Biotech and pharmaceutical companies rely on the FDA for dependable guidance as they spend huge sums developing new treatments. The American public needs the agency to ensure treatments are safe and effective…. Driving the news: The latest uproar surrounds the unexpected departure of Richard Pazdur, a respected oncologist who just three weeks ago became the fourth person to direct the FDA's drug center this year."
Sullivan adds, "Pazdur's appointment had helped calm nerves to some degree within industry after months of turmoil. But now, executives and even former FDA commissioners are publicly questioning the agency's direction."
One of the people who is sounding the alarm about the FDA is Biotechnology Innovation Organization CEO John Crowley.
Crowley told Axios, "This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China."
According to Sullivan, "morale" has "plummeted" at the FDA.
A former FDA staffer, interviewed on condition of anonymity, told Axios, "They don't talk to each other. They go to the bathroom, they come (back), they shut their door."
*Read Peter Sullivan's full article for Axios is available at this link.
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an 7 25
One prominent far-right social media personality sometimes seen in President Donald Trump's orbit has carved out a niche for herself as the president's "loyalty enforcer," according to the New York Times. But one attorney representing administration officials who have been fired is publicly condemning her influence.
The Times reported Wednesday on the growing power MAGA activist Laura Loomer has over personnel decisions in the executive branch. Loomer has already gotten Trump to fire several officials who were deemed insufficiently loyal over past social media posts criticizing the president and his base. However, Kevin Carroll — a former CIA official and lawyer who has been retained as counsel by some of those former employees — said that Loomer's attempts to ferret out anyone who has ever spoken negatively about the president could have significant blowback.
"You have a person, from outside of the government of no national security experience and with extreme views, having de facto hire and fire authority over some of the most senior and important positions in the United States government," Carroll told the Times.
READ MORE:(Opinion) Trump has only one way out of this mess
"Eventually, when all of the qualified people are driven out and only the people acceptable to Laura Loomer remain, there could be an extremely bad result for the United States in some international crisis," he continued.
Loomer has already claimed responsibility for driving out the top two officials at the National Security Agency (NSA) — former director Timothy Haugh (a four-star general), deputy director Wendy Noble and chief counsel April Falcon Doss — along with several others. This week, Dr. Vinay Prasad, who was the top vaccine official at the Food & Drug Administration, also resigned after Loomer discovered that he joked about using Trump as a voodoo doll in a 2020 podcast.
The Times reported that despite her devotion to Trump, Loomer wasn't given a job either in Trump's 2024 campaign or in the White House. But the social media personality indicated that she aimed to continue screening administration officials to ensure they were staunch Trump loyalists.
"I was raised to dress for the job you want, and even if you don’t have the job, pretend that you do,” Loomer said. “I want to do vetting, so I’m going to do the job I want.”
READ MORE:'Look stupid': Attorney reveals key sign that shows Trump nervous about Epstein questions
Click here to read the full Times report (subscription required).
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The administration of President Donald Trump told the public nothing of a hazardous E. coli outbreak that killed one person and sickened nearly 100 more — including one Indiana boy who became severely ill.
The bacteria, commonly found in feces, damaged 9-year-old Colton George’s kidneys and put him on dialysis. It was also “a genetic matchto the strain that killed one person and sickened nearly 90 people in 15 states last fall,” reports the Washington Post. “Federal health agencies investigated the cases and linked them to a farm that grew romaine lettuce.”
However, the paper reports most people have never heard of this outbreak, which experts say is runs counter to federal health practices.
READ MORE:A veteran tells Trump 'to go straight to hell'
“There were no public communications related to this outbreak,” says a heavily redacted February internal Food and Drug Administration memo that witholds the name of farm that served as the source of the outbreak. The federal government refused to name the business “because there was no product remaining in commerce” at the time of the report.
“Victims have a right to know who made them sick. This is my kid. He’s my life," said George's father, Chris George.
The Washington Post reports Trump officials have still never issued public communications after the investigation or identified the grower. The public might not know of the outbreak today had George’s parents not filed a lawsuit against the lettuce grower in April in federal court for the Southern District of Indiana.
In addition to failing to publicize a major outbreak and scaling back safety alert specialists and rules, the Trump administration’s has also withdrawn a proposed Biden-era regulation to reduce the presence of salmonella in raw poultry. That regulation, estimates the Food Safety and Inspection Service, could have prevented up to almost $30 million worth of illness in roughly 3,000 victims from chicken and turkey products
READ MORE: Struggles to 'even finish a sentence': Behind the obvious signs of Trump’s growing dementia
In addition, the Washington Post reports the administration is “disbanding a Justice Department unit that pursues civil and criminal actions against companies that sell contaminated food and is reassigning its attorneys.”
Staffing cuts at the FDA and CDC will mean further delays in publicizing deadly outbreaks, said former FDA worker Susan Mayne, an adjunct professor at Yale School of Public Health.
“Consumers are being notified with delays about important food safety notifications,” she said, referring to a recent outbreak in cucumbers. “People can die if there are pathogens like listeria, which can have a 30 percent fatality rate.”
Read the full Washington Post report here.
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eg henry miller: https://www.cato.org/publications/commentary/end-fda-drug-monopoly-let-patients-choose-their-medicines
doug bandow
...All told, Avik Roy of the Manhattan Institute figured that the consequences if unnecessary regulation “are higher‐than‐necessary health spending and poorer health outcomes. Pharmaceutical companies charge more for their products, in order to recoup their costly and risky investments. And fewer beneficial drugs reach doctors and patients.”
Of course, the FDA claims to protect the public from unsafe, ineffective drugs. But the agency can make two different errors. One is to approve bad products. The other is to block (or delay) good products. Noted Henry Millerof the Hoover Institution: “Public health is harmed when potentially beneficial products are delayed, abandoned, or never tested at all.”...
The greatest harms from drugs typically result from misuse or misprescribing rather than unexpected side effects. The deadliest latter problem pre‐1962 involved Elixir Sulfanilamide, which killed 107 people. Through 1980, figured Dale Gieringer, an expert in drug regulation, the highest death toll may have been 3500 dead around the world due to Isoproterenol, an inhaler for asthmatics. (Thalidomide resulted in 10,000 or more birth defects, but no deaths.)
In recent years significant drug problems have typically involved deaths in the scores. In 2007 Merck settled roughly 3500 death claims charged to the painkiller Vioxx without admitting that the drug was responsible (the company won 11 of 16 individual cases before agreeing to general settlement). Moreover, argued Gieringer: “there have been only one or two major drug accidents that could have been averted through stricter premarket testing, and one or two that could not have been prevented.”
The death toll from over‐regulation is far greater. Pharmacologist William Wardell concluded that the five year delay in allowing the hypnotic Nitrazepam to be used in America (after Britain’s approval) cost 3,700 lives. He believed that the FDA also cost thousands of lives by preventing the sale of the first beta‐blocker Propranolol for three years after it was available in Europe, and another seven years before it could be used for its most useful purposes.Sam Kazman of the Competitive Enterprise Institute (CEI) figured the annual beta‐blocker toll at 17,000. Overall, he wrote, “as many as 100,000 people may have died waiting for FDA to act.”
Indeed, CEI warned that the agency has delayed the arrival of a host of live‐saving medicines: ancrod, citicoline, ethyol, femara, glucophage, interleukin‐2, navelbine, lamictal, omnicath, panorex, photofrin, prostar, rilutek, taxotere, transform, and vasoseal. While the specifics vary, the combined human cost has been high. Gieringer explained: “The benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade or 10,000 per decade for worst‐case scenarios. In comparison… the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade. These figures would seem to support the conclusion that the costs of post‐1962 regulation outweigh benefits by a wide margin, similar to Peltzman’s results of a 4:1 cost‐benefit ratio for the 1962 amendments.”...
==
https://www.statnews.com/2018/01/30/pharmaceutical-industry-fake-news-tobacco/
pt
Accusations of “fake news” are all the rage now, with people often throwing around the term when they read an article that tells them something they don’t want to hear. But an entire industry called “product defense,” created years ago by the tobacco industry, uses falsehoods and misdirection to protect companies from bad media and regulatory scrutiny. The pharmaceutical industry is no stranger to these tactics.
Document archives have revealed how tobacco companies helped create and hone product defense strategies. In my years as a reporter and during a stint as an investigator for the U.S. Senate, I’ve seen them deployed by a range of industries.
I fell into this world back in 2005, while working as an editor for the news section of Environmental Science & Technology, the top journal in the field of environmental science. After spending weeks digging through the tobacco archive, I wrote a story about Steven J. Milloy, a columnist for FoxNews.com who ran a website called JunkScience.comand headed a shady organization called The Advancement of Sound Science Coalition (TASSC). In a 1993 letter, the public relations firm APCO explained how it launched TASSC “to expand and assist Philip Morris in its efforts with issues in targeted states in 1994.”
While I never learned if Milloy had direct ties to pharmaceutical companies, he had published a book called “Silencing Science” that argued regulatory agencies like the Food and Drug Administration had “eliminated science from public policy.” Milloy was also one of the early defenders of Vioxx, arguing that a study that caused the drug to be withdrawn for increasing the risk of heart attacks was a “tremendous overreaction.”
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trump called FDA deep state on annoucement, relative vs absolute
https://www.alternet.org/2020/08/trump-and-his-fda-commissioner-grossly-misrepresented-data-on-blood-plasmas-benefits-in-treating-19-patients-scientists/
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https://www.alternet.org/2020/08/the-head-of-the-fda-is-forbidden-from-speaking-to-press-without-a-trump-minder/
kos
t*he New York Times* has a long look questioning whether Food and Drug Administration head Stephen Hahn is being forced into giving the nation subpar advice on the demand of the anti-science, anti-reality narcissistic idiot manchild posing as the current president. It is full of the usual back and forth, both-siding quotes while laying out reams of evidence that actually this is not a question at all. The plain history shows that Dr. Hahn has absolutely been mealymouthing FDA pandemic advice to dodge contradicting Donald Trump’s most egregiously ignorant and magic-minded proclamations. It’s the sort of piece where you get the subject, Hahn, assuring the reporter that he is absolutely not feeling “squeezed” before the reporter casually throws in:
“On the line as he spoke was Michael Caputo, a deputy to Dr. Hahn’s boss, Alex M. Azar II, the secretary of the Department of Health and Human Services. […]Dr. Hahn is not allowed to speak to the press without Mr. Caputo or another official on the phone.”
There you go, America. Question answered. The head of the Food and Drug Administration is forbidden from talking to the press about the pandemic, period, unless an administration minder is present.
Another of global authoritarianism’s most consistent policies gets plunked down into the federal government, and we learn of it in a piece questioning whether everything is fine or is maybe something odd and disturbing going on here.
while the FDA gives rush approval to a supposed Trump miracle drug, sans evidence, only to have to warn later that oops it may turn out that the drug not only doesn’t work but may result in the dangerous side effects already known and printed on the packaging.
Oh, and we also learn that Hahn was discouraged from reaching out to private companies to develop COVID-19 tests back in January, according to four administration sources. That was back when the Trump administration, meaning Donald, was absolutely determined to ignore the pandemic away from the United States and absolutely did not want health officials giving dire warnings or taking drastic actions to actually prepare for the pandemic when it arrived.
Don’t worry, though. Trump’s Health and Human Services head Alex Azar said that never happened. Those other four sources must have imagined it.
We really are just unimaginably slow on the draw, here. There are 160,000 Americans dead, and it’s going to be next to impossible to limit it to anything else than a quarter million dead by the end of the year. And the most aggressive action to date by the Trump clan is to make sure minders are minding any federal expert whose expertise might publicly contradict whatever Typhoid Hitler’s fevered brain has pushed out his mouth on any particular morning. Is this unusual? Yeah, it’s pretty damn unusual. Is this damaging the nation’s response to a pandemic? Look around the planet: It’s the defining feature of our nation’s response to the pandemic.
We are supposed to feel sympathy for Dr. Hahn, because if he wants to retain his position he is absolutely forbidden from getting on Donald Trump’s bad side—and contradicting Donald Trump under any circumstances will immediately put him on Trump’s bad side. We are supposed to be begrudgingly grateful that Dr. Hahn and others are doing their best to dodge massive, murderous incompetence to keep more Americans alive than Trump’s core team have shown interest in, because if they resigned their posts in disgust Trump, Kushner, Meadows and the rest would simply ignore whatever laws were necessary to put a loyalist in with no such moral qualms.
We have to phrase all of this delicately, with a touch of both sides do it and a large dose of yes, this is all unusual in the extreme but far be it from us to say this is any better or worse than the old way of running the country,because doing otherwise would send Americans into a panic. It would cause politicians supporting the New Way to get very, very angry.
It may be brazenly obvious that Trump’s incompetence is killing people and his staff is primarily devoted to making sure nobody in the federal government suggests anything better, but there are still no editorial pages demanding he step down. None asking that the 25th Amendment be invoked despite his obvious forays into delusion.
Nothing about this is normal. A great deal of it was previously presumed to be illegal. There is an overwhelming push to normalize it down to mere partisan controversy, though, so nobody has to too deeply consider the underlying implications.
==
to be fair, grifters?
https://www.alternet.org/2020/05/trump-administration-orders-halt-to-first-of-its-kind-covid-19-testing-at-home-project-backed-by-bill-gates/
The Trump administration has ordered an “innovative” and “first of its kind” at home coronavirus testing program that has the support of Bill Gates and other public health experts to cease, and it’s unclear why.
:{
}:
The program, as The New York Times and NPR affiliate KUOW report, is based in Seattle, Washington, and allowed residents to easily test for coronavirus. One of the program’s benefits is 43 percent of its more than 12,000 participants so far were asymptomatic. To date the program has identified dozens of previously-undetected COVID-19 cases.
The Seattle Coronavirus Assessment Network (SCAN), operated by researchers from the Seattle Flu Study and Public Health – Seattle & King County, and had an “in-person technical adviser” from the Centers for Disease Control and Prevention, was authorized by the State of Washington.
“Please discontinue patient testing and return of diagnostic results to patients until proper authorization is obtained,” the FDA ordered, saying it had “concerns about safety and accuracy."
SCAN’s researchers say they had, The Times reports, “submitted data validating both the safety and reliability of the swabs in home-based collection.”
One researcher not affiliated with the program called halting it “bizarre.”
It’s unclear if Bill Gates’ association with the project has any negative impact. Some far right conspiracy theorists among Trump’s base, including those protesting state stay-at-home policies, falsely claim Gates is developing a vaccine that contains a microchip to track those who get injected.
President Donald Trump has been very concerned with the actual numbers attached to coronavirus cases and has made clear he wanted to keep the numbers low to help his re-election campaign.
He has said, “we don’t want everybody taking this test,” referring to coronavirus testing. “It’s totally unnecessary. This will pass through and we’re going to be even stronger for it.”
On Thursday Trump said testing for coronavirus is “overrated,” and complained that the more tests are conducted, the more cases there are.
“When you test, you have a case,” Trump said in Allentown, Pennsylvania. “When you test, you find something is wrong with people. If we didn’t do any testing we would have very few cases.”
==
1219
report by the Environmental Working Group reveals that an estimated 2,000 untested chemicals, several of them known or suspected carcinogens, are legally present in conventional packaged foods sold in U.S. supermarkets. But this major public health concern is largely unrecognized by the Food and Drug Administration, which operates under a policy on food additives dating back to 1958.
By Melissa Kravitz Hoeffner, Independent Media Institute
A major but largely glossed over report by the Environmental Working Group (EWG), an environmental and public health nonprofit based in Washington, D.C., shows that thousands of untested chemicals (an estimated 2,000, to be exact) are found in conventional packaged foods purchasable in U.S. supermarkets. And yes, all of them are legal.
The extensive collection of permissible additives includes several known or suspected carcinogens, such as synthetic sodium nitrate, found in processed meats and considered probably carcinogenic by the World Health Organization, and butylated hydroxyanisole, also known as BHA, a chemical listed as a cancer-causing chemical by the state of California and found in commonplace items like frozen pepperoni pizza. Other unappealing chemicals are commonly found in our food packaging, such as polypropylene, sulfuric acid andbisphenol A—all of which can have impacts on human health and the environment.
How much should consumers panic before their next supermarket trip? “It really depends on what level of risk consumers are comfortable with,” says Dawn Undurraga, a nutritionist at EWG and co-author of the study. “The more we learn about what is in conventional foods, the more evidence for concern we accumulate.” Independent laboratory tests commissioned by EWG, for example, found **glyphosate**, a probable carcinogen, in every sample of conventional oats tested.
The fact that dangerous chemicals are legal for use in our food is a major public health concern that goes largely unrecognized by the U.S. government. “Unfortunately, our current policy on food additives was written in 1958 and has been completely co-opted by food and chemical companies,” Undurraga says. “Additives that are deemed ‘Generally Recognized as Safe,’ or GRAS, by a food or chemical company or trade association are exempt from the food additive petition process where the U.S. Food and Drug Administration (FDA) reviews the safety of the additive.”
Originally, this GRAS exemption was created to cover ingredients widely known to be safe, like vinegar, but with advancements in food science, the provision has been applied to thousands of chemicals. As a result, questionable substances have been allowed into a host of conventional foods. In 2017, EWG joined several other public health groups to file a lawsuit against the FDA in an effort to eliminate the GRAS loophole.
“Rather than close the loophole, the FDA has instead allowed companies to voluntarily notify the agency about food chemicals and to allow companies to summarize the industry science supporting their conclusions,” reads the EWG study, elucidating that many scientists who conduct these reviews have been paid by the industry. Plus, the FDA does not subsequently review underlying biological and chemical data, leaving consumers to literally do the dirty work. The FDA did not respond toTruthout’s request for comment.
“Consumers shouldn’t have to be toxicologists to be able to grab something at the grocery store that doesn’t contain questionable or dangerous ingredients,” Undurraga says. Even so, toxicology literacy won’t help in the frozen food aisle. According to Undurraga, there are absolutely no defining signs on food packaging to indicate that any of the 2,000 synthetic chemicals approved for use in food are present in that specific item.
In fact, the only way to minimize exposure to these chemicals is to purchase certified organic packaged foods and look at EWG’s Food Scores, which measure nutrition, ingredient and processing concerns in more than 80,000 common foods, from frozen vegetables and baby food to packaged nuts, berries and grains across hundreds of popular brands; and EWG’s Dirty Dozen List of Food Additives, which ranks the worst food additives common in U.S. supermarket food and where you’ll likely encounter them, like potassium bromate in packaged loaves of bread and propylparaben in packaged tortillas and muffins.
If additives don’t have you worried enough about what we’re legally permitted to consume, know that pesticides, found to be carcinogenic and also severely damaging to the environment, are still more than prevalent alongside the packaged food chemicals at your grocery store. Every year, EWG reviews the U.S. Department of Agriculture’s pesticide residue tests on conventional produce.
“Last year, nearly 70 percent of conventionally grown produce was contaminated with pesticide residues,” says Undurraga. “This is especially concerning for pregnant women and small children.”
Sure, organic packaged food and organic produce are typically more expensive than their conventional counterparts, but you’re paying for more rigorous additive standards and investing in your long-term health and the health of the environment. Currently, fewer than 40synthetic ingredients are permitted in organic packaged foods—and this is only after each chemical has been reviewed by both independent and government experts. And yet only around 3 percent of packaged food sold in the U.S. is organic. Perhaps this is because people who shop organic are not interested in pre-packaged meals. More likely, it’s because the dangers of conventional packaged food are not well-known.
Those who want to plan their supermarket trips with a budget in mind can look to EWG’s shopper’s guide to know what to prioritize in their carts. Beyond opting for organic packaged goods when going the pre-made route, consumers can elect to buy organic versions of fruits and vegetables whose conventional counterparts have made EWG’s “Dirty Dozen” list, which calls out those conventionally grown items found with the most pesticide residue: strawberries, spinach, kale, nectarines, apples, grapes, peaches, cherries, pears, tomatoes, celery and potatoes.
On the flip side, consumers can opt for conventional versions of the produce items that are listed on EWG’s “Clean Fifteen”—those with relatively little pesticide residue: avocados, sweet corn, pineapples, frozen sweet peas, onions, papayas, eggplants, asparagus, kiwis, cabbages, cauliflower, cantaloupes, broccoli, mushrooms and honeydew melons.
Though it’s unlikely Americans are going to stop buying conventional packaged food in the near future (or ever), pressure on the government to make packaged food actually safe to eat is necessary to enact change. And with so little information readily available about what we’re actually eating when these chemicals aren’t disclosed, keeping up with research by independent groups like the EWG remains imperative to educate consumers.
Combining their research and policy platform, EWG has launched a petition to encourage food companies like General Mills, Quaker and Kellogg’s to remove cancer-linked glyphosate from our food. And that’s just the beginning. Other consumer safety advocates, including the Environmental Defense Fund and the Center for Food Safety, both represented by Earthjustice, have challenged the FDA’s GRAS interpretation in court earlier this year.
Ignorance may bring peace of mind to grocery shoppers, but as more information about the hazards in our daily food purchases comes to light, it’s likely we’ll see more consumer pushback against dangerous practices that have become the norm.
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Vaping Lung Illness: Why E-Cigarettes' Dangers Might Get ...
https://www.theatlantic.com › health › archive › 2019/09 › vaping-illness
1.
Missing: entine | Must include:entine
Juul Illegally Marketed E-Cigarettes, F.D.A. Says - The New ...
https://www.nytimes.com › 2019/09/09 › health › vaping-juul-e-cigarettes-fda
Sep 9, 2019 - Juul Labs, the dominant e-cigarette company, illegally marketed its vaping products as a less harmful alternative to traditional cigarettes, the ...
Missing: entine | Must include: entine
Juul warned over claims its e-cigarette is safer than smoking
https://www.wlbt.com › 2019/09/09 › juul-warned-over-claims-e-cigarette-sa...
Sep 9, 2019 - WASHINGTON (AP) — Federal health authorities on Monday blasted vaping company Juul for illegally pitching its electronic cigarettes as a ...
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stem cells
For more than half a century, the regenerative possibilities of stem cells — which the body stores to repair damaged tissue and organs and restore blood supply — have tantalized the medical community. Bone marrow transplants for cancer patients, which rely on blood stem cells, fulfill this potential. But alongside legitimate, scientifically proven treatments, an industry has sprung up in which specialized clinics offer miracle remedies from poorly understood stem cell products.
These clinics are multiplying in the United States. According to a tally by Leigh Turner, an associate professor of bioethics at the University of Minnesota, there were 12 such clinics advertising to consumers in 2009; in 2017, there were more than 700. Unproven cellular therapies are a $2 billion global business, according to a recent paper co-authored by Massimo Dominici, the lead investigator at the cellular therapy lab at the University of Modena and Reggio Emilia, in Italy.
This burgeoning business is largely unregulated. Technically, manufacturers are required to submit stem cell therapies for review as a drug, and to provide evidence of their safety and efficacy, but the U.S. Food and Drug Administration hasn’t enforced the rule consistently. The former FDA commissioner Dr. Scott Gottlieb acknowledged in an interview that the agency’s laissez-faire attitude has made it easier for stem cell clinics to proliferate. “This is an example where the FDA, for a long period of time, took enforcement discretion, then the field grew,” he said. “Then it becomes hard to step in and actually apply the regulation.”
Many clinics offer stem cells taken from a patient’s own bone marrow or fat. But they’re being challenged by a newer technology: amniotic stem cells.
Greene’s company, R3 Stem Cell, was established in 2013. It distributes amniotic stem cells to about 30 clinics nationwide, which have administered them to 10,000 patients, according to an R3 brochure. It also handles marketing for the clinics. In an interview, Greene acknowledged that the benefits of amniotic stem cells that he touted at the Robson Ranch seminar are based on “a lot of success stories,” rather than on clinical trials. “I don’t claim anything,” he added. “I don’t claim that this is a treatment. I don’t claim that it cures anything. I don’t claim that it’s a permanent fix. All I discuss is maybe, potentially, people can get some improvements from stem cell care.”
One appeal of amniotic stem cell treatments is convenience. They don’t require patients to undergo liposuction or bone marrow extraction; instead, manufacturers harvest the cells from tissues donated by women who have recently given birth, and the cells are then frozen and shipped to clinics. There’s no special training needed to administer amniotic treatments, either — a nurse practitioner on staff can give injections — so chiropractors, beauticians and sports medicine doctors can enter the field with relative ease. A procedure such as an injection into a joint might take about 10 minutes and cost between $5,000 and $10,000. For systemic diseases such as lupus, some clinics also administer the cells intravenously, which can cost more than $10,000 per session.
Because amniotic stem cell treatments don’t undergo the clinical trials required for FDA approval, there’s little data or research on them. Their efficacy is highly questionable and, in one case where bacteria contaminated the supply, the lack of accountability in the industry has led to serious infections for a dozen patients. An investigation by ProPublica and The New Yorker found disgraced doctors who were recast as salespeople, manufacturers that cloaked themselves in pseudoscience and had few scientists on staff, and clinics that offer to treat conditions like multiple sclerosis or kidney disease without specialized training. Unscientific methods, deceptive marketing, price gouging and disregard for patients’ well-being were rampant across the amniotic stem cell therapy industry.
The supply chain for amniotic therapy starts and finishes with people who are at vulnerable times in their lives: the cells come from new mothers and go to chronically ill patients. Women who undergo cesarean sections are often asked to donate their birth tissue shortly before the procedure. By law, they can’t be compensated for it. Mothers who donated their tissue told ProPublica and The New Yorker that they assumed, or were assured, that it would be used for a worthy cause — and that otherwise it would be disposed of as medical waste. But they couldn’t recall the details of the donation process, owing to the haze of childbirth....
https://www.alternet.org/trump-peddles-false-hope-terminally-ill-right-try-law
...
doctors and medical researchers were casting doubt on Trump’s claims. At best, the Right to Try law will help a few patients suffering from certain terminal illnesses for which there are promising treatments under review, but only if they are wealthy enough to pay for the treatments and the cost of treating any negative side effects, most likely without help from their insurance plan. For this reason alone, the new law is not expected to help nearly as many people as Trump claims.
At worst, critics say Right to Try is a stealth attempt by libertarian ideologues to undermine patients’ rights and chip away at the FDA’s regulatory authorityover chemicals that have yet to be proven safe and effective. Medical experts point out that theFDA already has a program for allowing patients to try drugs that have not completed clinical trials, and the agency approves 99 percent of applications. The Right to Try legislation simply cuts government watchdogs charged with protecting consumer safety out of the process.
Of course, the experimental chemicals and devices patients now have the “right” to try must also be effective at treating serious illness without presenting intolerable side effects. According to Vinay Prasad, a doctor and professor of medicine at Oregon State University, this is a feat achieved by only 10 percent of drugs that initially enter clinical trials. Manufacturers must also agree to provide them in the first place.
“It isn’t accurate to call these drugs, though, because they are just chemicals, most of which don’t work,” Prasad said.In a series of tweets, Prasad said Right to Try advocates associated with conservative groups like Americans for Prosperity and the Goldwater Institute had created a “misleading narrative” about a large number of patients who had exhausted their options and wanted to try new drugs. (Right to Try advocates routinely campaigned with sick children to pass laws in a number of states, and a young boy battling muscular dystrophy joined Trump as he signed the bill into law.)
Vinay Prasad@VinayPrasadMD30 MayReplying to @VinayPrasadMD
This group & partners created a misleading narrative where many sick patients had exhausted proven options and wanted to try "drugs" that were still in clinical trials.
It isn't accurate to call these drugs, though, because they are just chemicals, most of which don't work.
In fact,:{ multiple studies show that most of these chemicals do not come to market FOR ANY PURPOSE.
~10% come to market FOR SOME USE, but maybe not the use you wanted to "try" it for (i.e. true % chance of benefit, even lower) pic.twitter.com/tSb5rrMJAC}:
Vinay Prasad@VinayPrasadMD30 MayReplying to @VinayPrasadMDThe legislation does protect health providers and pharmaceutical companies from legal liability if their experimental products do more harm than good, but manufacturers may not feel protected until that language is tested in court. Despite the “Right to Try” moniker, the law offers no new rights to patients besides the ability to seek treatments that have not been tested and approved by the FDA.
Also worth noting that the FDA is not holding back cures in cancer or other serious ailments
In fact, they are rubber-stamping the most toxic, and marginal products
The:{ avg cancer drug approved adds 2 months of life!
in ideal settings
less in real world//www.nfrank.info/site/ckfinder/userfiles/pdf/Unitended%20Consequences%20of%20Expensive%20Cancer%20Therapeutics.pdf …pic.twitter.com/1Vk1eWK4oG}:
I find it interesting to note what the Right to Try bill does not include
No "Right to Have Approved Drugs Be Affordable"
No "Right to Have Pharma make Better Drugs"
No "Right not to go bankrupt from paying for drugs you need"
No "Right to make companies GIVE the drug"
For these reasons, medical experts argue that the Right to Try law will do little for most families facing a terminal illness, all while curtailing the FDA’s ability to control access to investigational drugs. That’s why more than 300 doctors and academics signed a letter in February urging members of Congress to ditch the legislation, despite pressure from Trump and Vice President Mike Pence.
“This legislation sells vulnerable patients and families false hope at the expense of weakening the FDA’s critical role in making sure that all Americans can have confidence in the safety and effectiveness of our medical products,” the authors wrote, adding that their view is shared by the American Lung Association, the Children’s Brain Tumor Foundation, the National Health Council and many other groups.
When it comes to policy, Trump has never been concerned with the fine print. That’s a job he leaves up to staffers and members of his cabinet, many of whom come directly from the world of big business or the far right of the Republican Party. The president promotes their policies with broad strokes and bold promises, just as he did on Wednesday as he signed the Right to Try bill and declared a victory during another week of damaging headlines. In politics, however, the devil is in the details, and what Trump wants you to see on TV is not always what you get.
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The Department of Health and Human Services has become another source of potential conflicts.
Lance Leggitt, who serves as chief of staff to Tom Price, the health and human services secretary, worked last year as a lobbyist for 10 different health care companies, including United States Medical Supply and Advanced Infusion Services. He focused largely on lobbying the agency related to Medicare billing rules, as well as rules for health care supplier accreditations, lobbying disclosure reports show. All these issues are routinely handled by the agency he helps oversee.
Dr. Scott Gottlieb, the nominee to lead the Food and Drug Administration, received more than $350,000 in payments in 2014 and 2015 from nearly a dozen different pharmaceutical companies, including Vertex Pharmaceuticals, whose two approved drugs are seen as breakthrough treatments for cystic fibrosis. (They carry list prices of more than $250,000 a year.) Dr. Gottlieb, who has never been registered as a lobbyist but has served as the director of eight pharmaceutical companies and one laboratory company, wrote in a letter that he was prepared to recuse himself as necessary to avoid any conflicts.
The Department of Health and Human Services did not respond to a request for a comment.
==
Robert F. Kennedy Jr. did have time, however, to spell out the quarter century that it took for the U.S. government to fully shield the pharmaceutical industry from product liability lawsuits. That was back in 1988 when Congress injected the provision in the National Vaccine Injury Compensation Program (NVICP) Act.
From there, all big pharma had to do was buyoff the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to ensure that more vaccines were added to the schedule, which for the past 15 years has three times the number of shots in the U.S. vaccine schedule than any other nation in the western hemisphere.
Then the crafty feint the U.S. government did with NVICP, or “Vaccine Court” as it’s known, was to gut the spirit and charter of the act. They rewrote the standard of injury to a victim of thimerosal by protecting mercury itself from such lawsuits.
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6/15
harmaceutical interests are pushing hard in favor of a bill that could speed up Food and Drug Administration (FDA) approval of new drugs. But the bipartisan 21st Century Cures Act, which was approved last month by the the House Energy and Commerce Committee (the members of which have all sponsored the bill) and could reach the House floor by the end of June, has some health advocates up in arms.
A primary concern is that the bill would encourage the FDA to move away from its reliance on controlled trials — and specifically those using randomization — as the main marker for determining whether a drug is safe and effective enough to go on the market. Instead, it suggests that “clinical experience,” which includes observational study, patient anecdotes, and other such methods, be given more consideration. Clinical experience is and has been used as supplemental evidence by the FDA, but not as the primary method for determining a drug’s safety and efficacy.
Dr. John Powers, the former lead medical officer for antimicrobial development and resistance issues at the FDA and a member of the National Physicians Alliance’s FDA task force, said that such a method was akin to using “Star Trek medicine mentality” that relies on unsubstantiated belief instead of valid scientific evidence.
“The number of ways patients can be different from each other that can influence patient-centered outcomes independent of treatment is innumerable,” Powers told OpenSecrets Blog, adding that with clinical experience, one “can’t take into account all complexities that happen in the human body.”
The 21st Century Cures initiative was launched on April 30, 2014 by House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and committee member Diana DeGette (D-Colo.), and a white paper on the initiative was released the following day. The legislation, which was introduced by Upton last month (with adiscussion document released in January), currently has 138 sponsors — most of whom boast the pharmaceuticals/health products industry as one of their top 20 contributors in the 2014 election cycle.
That includes all of the bill’s original sponsors: $302,700 for Upton, $184,500 for Joe Pitts(R-Pa.), $174,072 for Frank Pallone (D-N.J.) — the Committee’s ranking member, $112,949 for DeGette and $72,044 for Gene Green (D-Texas).
Pallone’s district contains the headquarters of pharmaceutical giant Johnson & Johnson, whose PAC gave him $10,000 in the last election cycle.
The company has lobbied on the initiative as well — as have numerous pharmaceutical companies and trade groups, which bring vast resources to bear on anything going on in Washington that might affect their interests. In fact, the pharmaceuticals/health products industry consistently spends more on lobbying than any other interest group. Big spenders over the past two years that have mentioned the initiative most frequently in lobbying reports include drug companies Sanofi(which spent nearly $6 million on lobbying in 2014, $1.8 million in the first quarter of 2015), AstraZeneca PLC ($2.9 million in 2014, $503,000 in 2015) andGlaxoSmithKline ($4.4 million in 2014, $1.7 million in 2015) — as well as industry associations such as the Biotechnology Industry Organization ($8.3 million in 2014, $2 million in 2015) and the Pharmaceutical Research & Manufacturers of America(PhRMA) ($16.6 million in 2014, over $5.4 million in 2015).
Both name brand and generic drug companies, often at odds, want the bill to go through. The Generic Pharmaceutical Association‘s President and CEO Ralph G. Neas referred to it in a press release as a “bipartisan achievement that should enhance the drug approval process and significantly boost critical research and development efforts.”
In the first quarter of 2015, 208 entities lobbied on the initiative, a list with countless pharmaceutical and biotechnology-centered companies.
A spokeswoman from the House Energy and Commerce Committee maintains that safety will not be compromised by the bill. “Modernizing health care innovation and maintaining the highest standards of safety and efficacy are not mutually exclusive,” she said. “This is why the committee brought every key player to the table — including the FDA, the NIH, top scientists, researchers, and thought leaders — for more than a year to carefully develop this vital legislation.”
Former FDA commissioner Andrew von Eschenbach, who served under former President George W. Bush, along with Manhattan Institute scholar Paul Howard, wrote in support of the bill in the *Morning Consult* this week. “Armed with massive computing power and modern analytics, advanced diagnostics like functional MRIs, and electronic medical records, researchers can now compile massive databases containing genomic variants and patient health outcomes that can allow them to rapidly identify, test, and validate hypothesis about effective disease fighting strategies,” von Eschenbach and Howard write. “With this information in hand, it is unnecessary and perhaps even unethical to demand that we conduct traditional large, blinded and randomized controlled trials for precision medicines supported by a variety of mechanistic and pre-clinical data.”
But two other former FDA commissioners have concerns with 21st Century Cures — even though it does allotover $10 billion to the National Institutes of Health (NIH) and $550 million to the FDA over five years. Margaret Hamburg, a recently departed commissioner, said in a March speech, that “there’s a misperception that you might be able to speed up innovation by lowering the standards for safety and efficacy, and I think that would be a terrible mistake that would not only just damage patients, but industry as well.” David Kessler, who served as commissioner during both the George H.W. Bush and Bill Clinton administrations, wrote this month in a joint *New York Times* op-ed that the act “could substantially lower the standards for approval of many medical products, potentially placing patients at unnecessary risk of injury or death.”
And the National Center for Health Research, a think tank involved in research “used to encourage new, more effective programs, policies, and medical treatments,” is also worried about the legislation. In addition to uneasiness about relying on clinical experience, other concerns include parts of the Act that would allow new drugs to be approved for select individuals based on preliminary data, create financial incentives for the use of new antibiotics, and could allow companies to use limited evidence in order to get FDA approval for new medical devices.
So far, it’s only in the House where the two sides are tussling over whether the bill is a salutary prescription; no companion measure is yet pending in the Senate.
Correction, 6/16: This post has been corrected to reflect the fact that formal 21st Century Cures legislation was not introduced until the second quarter of 2015; the companies mentioned lobbied on the initiative.
Categories: Chemical & Related Manufacturing Congress Congressional Committees Influence & LobbyingLobbying Pharmaceutical/Health products Politicians & Elections
Tags: 21st Century Cures Act, alex lazar, astrazeneca, Bill Clinton, Biotechnology Industry Organization, David Kessler, Diana DeGette, Food and Drug Administration, Frank Pallone, Fred Upton, Gene Green, Generic Pharmaceutical Association, George H.W. Bush, George W Bush, glaxosmithkline, House Energy and Commerce Committee, Joe Pitts, Margaret Hamburg, National Institute of Health, New York Times,Pharmaceutical Research & Manufacturers of America, Ralph Neas, sanofi
http://www.opensecrets.org/news/2015/06/phrma-companies-push-hard-on-house-bill-to-ease-testing-of-new-drugs
==
Avandia controversy
Following Dr. Steven Nissen's publication of a study warning that "GlaxoSmithKline's diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%," he was publicly pilloried. "More than one story from ostensibly different sources" derisively referred to him as "St Steven," the "Patron Saint of Drug Safety," and "Saint Steven the Pure," reported Evelyn Pringle in an August of 2007 CounterPunch article.[14]
Among the Nissen attackers was Food and Drug Administration (FDA) spokesman Douglas Arbesfeld. Arbesfeld previously worked for the public relations firm Manning Selvage & Lee (MS&L), helping Glaxo and other "healthcare clients maximize internet-relations." Former FDA Deputy Commissioner Dr. Scott Gottlieb, who ridiculed Nissen in a Wall Street Journal editorial, also consulted for pharmaceutical companies at MS&L. Two more FDA alums, Peter Pitts and Robert Goldberg, mocked Nissen in a Washington Times piece. Pitts is the senior vice-president for global health affairs at MS&L. Goldberg doesn't have ties to the PR firm, but serves with Pitts as an officer of the Center for Medicine in the Public Interest (CMPI), which Pringle describes as a "nest of ex-moles who served the industry in one capacity or another in the Bush Administration's FDA."[15]
CMPI is a project of the**Pacific Research Institute**, a free market**think tank**.
See also GlaxoSmithKline, the Diabetes Drug Avandia and The Intimidation of Dr. John Buse
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The Food and Drug Administration has approved a new influenza vaccine for sale in the United States containing genetically modified organisms. The vaccine, Flublok, includes recombinant DNA technology and an insect virus called baculovirus. Insect cells programmed to produce hemagglutinin, a flu virus protein necessary for entry of the virus into the body’s cells. Flu […]
http://www.alternet.org/print/food/fda-moves-ban-heart-clogging-trans-fats
http://www.fooddemocracynow.org/blog/2011/sep/2/tell_obama_to_dump_monsantos_minion_at_the_fda/
Aspartame is not food. It’s defined as [14] a synthetic compound of two amino acids (l-aspartyl-l-phenylalanine o-methyl ester). The compound was discovered accidentally in 1965, by James M. Schlatter, a chemist at G.D. Searle Company. Schlatter was testing an anti-ulcer drug. When he licked his finger and discovered that his concoction tasted sweet, the market for artificial sweeteners was born.
Is aspartame safe? Not according to multiple studies conducted over decades. And, at one time, not according to the FDA. In 1975, the FDA put a hold on aspartame’s approval, citing deficiencies in the studies conducted by Searle and its contractors. An analysis [12] of 164 studies of aspartame’s potential impact on human safety found that of the 90 non-industry-sponsored studies, 83 identified one or more problems with aspartame. Of the 74 industry-sponsored studies, all 74 claimed that aspartame was safe.
So how did aspartame get into our food supply? We have Donald Rumsfeld, former U.S. Secretary of Defense to thank. In 1981, Rumsfeld, who had previously served as CEO of Searle, hand-picked [15] Reagan’s new FDA commissioner, Arthur Hayes Hull, Jr. It was Hull who ultimately gave aspartame the green light.
Here’s how it went down. On January 21, 1981, the day after Ronald Reagan's inauguration, Searle re-applied to the FDA for approval to use aspartame as a sweetener in beverages. Hull, the brand new FDA commissioner, recommended by Rumsfeld, appointed a five-person Scientific Commission to review the board of inquiry's prior decision. (A board of inquiry had been formed in 1975 when the FDA first questioned the validity of Searle’s studies on aspartame). When it became clear that the Scientific Commission was on track to uphold the 1975 ban by a 3-2 decision, Hull installed a sixth member on the commission. That led to a deadlocked vote. Hull then personally cast the tie-breaking vote. Voila. Aspartame was approved.
Hull soon left the FDA and eventually landed at Burston-Marsteller, the PR firm for Searle and for years, Monsanto. In 1985, Monsanto bought Searle and later spun off the company under the name NutraSweet. But not before Rumsfeld earned a handsome $12-million bonus, presumably for his role in greasing the wheels for aspartame’s approval.
In an article [16] published earlier this year in the New York Times, entitled “The Extraordinary Science of Addictive Junk Food,” Michael Moss exposed the junk food industry for employing chemists to concoct additives intended to hook people on the very food that is making us, including our children, not only obese, but chronically ill.
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How Aspartame Became
Legal - The Timeline
From Rich Murray
rmforall@att.net
12-24-2
From Norfolk Genetic Information Network (Taken from Welcome to the Spin Machine by Michael Manville http://www.freezerbox.com/archive/2001/04/biotech/ http://www.freezerbox.com/ )
In 1985 Monsanto purchased G.D. Searle, the chemical company that held the patent to aspartame, the active ingredient in NutraSweet. Monsanto was apparently untroubled by aspartame's clouded past, including a 1980 FDA Board of Inquiry, comprised of three independent scientists, which confirmed that it "might induce brain tumors."
The FDA had actually banned aspartame based on this finding, only to have Searle Chairman Donald Rumsfeld (currently the Secretary of Defense) vow to "call in his markers," to get it approved.
On January 21, 1981, the day after Ronald Reagan's inauguration, Searle re-applied to the FDA for approval to use aspartame in food sweetener, and Reagan's new FDA commissioner, Arthur Hayes Hull, Jr., appointed a 5-person Scientific Commission to review the board of inquiry's decision.[rumy head of trans team?]
It soon became clear that the panel would uphold the ban by a 3-2 decision, but Hull then installed a sixth member on the commission, and the vote became deadlocked. He then personally broke the tie in aspartame's favor. Hull later left the FDA under allegations of impropriety, served briefly as Provost at New York Medical College, and then took a position with Burston-Marsteller, the chief public relations firm for both Monsanto and GD Searle. Since that time he has never spoken publicly about aspartame.
The Aspartame/NutraSweet Timeline
http://www.swankin-turner.com/aspartame.html http://www.swankin-turner.com/hist.html
Aspartame/NutraSweet: The History of the Aspartame Controversy
By James Turner, ESQ. Director of the National Institute of Science, Law, and Public Policy (NISLAPP)
National Institute of Science, Law, and Public Policy 1400 16th Street, NW, Suite 330, Washington, DC 20036 (202) 462-8800 Fax: (202) 265-6564 nislapp@swankin-turner.com
Timeline
December 1965-- While working on an ulcer drug, James Schlatter, a chemist at G.D. Searle, accidentally discovers aspartame, a substance that is 180 times sweeter than sugar yet has no calories.
Spring 1967-- Searle begins the safety tests on aspartame that are necessary for applying for FDA approval of food additives.
Fall 1967-- Dr. Harold Waisman, a biochemist at the University of Wisconsin, conducts aspartame safety tests on infant monkeys on behalf of the Searle Company. Of the seven monkeys that were being fed aspartame mixed with milk, one dies and five others have grand mal seizures.
November 1970-- Cyclamate, the reigning low-calorie artificial sweetener -- is pulled off the market after some scientists associate it with cancer. Questions are also raised about safety of saccharin, the only other artificial sweetener on the market, leaving the field wide open for aspartame.
December 18, 1970-- Searle Company executives lay out a "Food and Drug Sweetener Strategy' that they feel will put the FDA into a positive frame of mind about aspartame. An internal policy memo describes psychological tactics the company should use to bring the FDA into a subconscious spirit of participation" with them on aspartame and get FDA regulators into the "habit of saying, "Yes"."
Spring 1971-- Neuroscientist Dr. John Olney (whose pioneering work with monosodium glutamate was responsible for having it removed from baby foods) informs Searle that his studies show that aspartic acid (one of the ingredients of aspartame) caused holes in the brains of infant mice. One of Searle's own researchers confirmed Dr. Olney's findings in a similar study.
February 1973-- After spending tens of millions of dollars conducting safety tests, the G.D. Searle Company applies for FDA approval and submits over 100 studies they claim support aspartame's safety.
March 5, 1973-- One of the first FDA scientists to review the aspartame safety data states that "the information provided (by Searle) is inadequate to permit an evaluation of the potential toxicity of aspartame". She says in her report that in order to be certain that aspartame is safe, further clinical tests are needed.
May 1974-- Attorney, Jim Turner (consumer advocate who was instrumental in getting cyclamate taken off the market) meets with Searle representatives to discuss Dr. Olney's 1971 study which showed thataspartic acid caused holes in the brains of infant mice.
July 26, 1974--The FDA grants aspartame its first approval for restricted use in dry foods.
August 1974-- Jim Turner and Dr. John Olney file the first objections against aspartame's approval.
March 24, 1976-- Turner and Olney's petition triggers an FDA investigation of the laboratory practices of aspartame's manufacturer, G.D. Searle. The investigation finds Searle's testing procedures shoddy, full of inaccuracies and "manipulated" test data. The investigators report they "had never seen anything as bad as Searle's testing."
January 10, 1977-- The FDA formally requests the U.S. Attorney's office to begin grand jury proceedings to investigate whether indictments should be filed against Searle for knowingly misrepresenting findings and "concealing material facts and making false statements" in aspartame safety tests. This is the first time in the FDA's history that they request a criminal investigation of a manufacturer.
January 26, 1977-- While the grand jury probe is underway, Sidley & Austin, the law firm representing Searle, begins job negotiations with the U.S. Attorney in charge of the investigation, Samuel Skinner.
March 8, 1977-- G. D. Searle hires prominent Washington insider Donald Rumsfeld as the new CEO to try to turn the beleaguered company around. A former Member of Congress and Secretary of Defense in the Ford Administration, Rumsfeld brings in several of his Washington cronies as top management.
July 1, 1977-- Samuel Skinner leaves the U.S. Attorney's office and takes a job with Searle's law firm. (see Jan. 26th)
August 1, 1977-- The Bressler Report, compiled by FDA investigators and headed by Jerome Bressler, is released. The report finds that 98 of the 196 animals died during one of Searle's studies and weren't autopsied until later dates, in some cases over one year after death. Many other errors and inconsistencies are noted. For example, a rat was reported alive, then dead, then alive, then dead again; a mass, a uterine polyp, and ovarian neoplasms were found in animals but not reported or diagnosed in Searle's reports.
December 8, 1977-- U.S. Attorney Skinner's withdrawal and resignation stalls the Searle grand jury investigation for so long that the statue of limitations on the aspartame charges runs out. The grand jury investigation is dropped.
June 1, 1979-- The FDA established a Public Board of Inquiry (PBOI) to rule on safety issues surrounding NutraSweet.
September 30, 1980-- The Public Board of Inquiry concludes NutraSweet should not be approved pending further investigations of brain tumors in animals. The board states it "has not been presented with proof of reasonable certainty that aspartame is safe for use as a food additive."
January 1981-- Donald Rumsfeld, CEO of Searle, states in a sales meeting that he is going to make a big push to get aspartame approved within the year. Rumsfeld says he will use his political pull in Washington, rather than scientific means, to make sure it gets approved.
January 21, 1981-- Ronald Reagan is sworn in as President of the United States. Reagan's transition team, which includes Donald Rumsfeld, CEO of G. D. Searle, hand picks Dr. Arthur Hull Hayes Jr. to be the new FDA Commissioner.
March, 1981-- An FDA commissioner's panel is established to review issues raised by the Public Board of Inquiry.
May 19, 1981-- Three of six in-house FDA scientists who were responsible for reviewing the brain tumor issues, Dr. Robert Condon, Dr. Satya Dubey, and Dr. Douglas Park, advise against approval of NutraSweet, stating on the record that the Searle tests are unreliable and not adequate to determine the safety of aspartame.
July 15, 1981-- In one of his first official acts, Dr. Arthur Hayes Jr., the new FDA commissioner, overrules the Public Board of Inquiry, ignores the recommendations of his own internal FDA team and approves NutraSweet for dry products. Hayes says that aspartame has been shown to be safe for its' proposed uses and says few compounds have withstood such detailed testing and repeated close scrutiny.
October 15, 1982-- The FDA announces that Searle has filed a petition that aspartame be approved as a sweetener in carbonated beverages and otherliquids.
July 1, 1983-- The National Soft Drink Association (NSDA) urges the FDA to delay approval of aspartame for carbonated beverages pending further testing because aspartame is very unstable in liquid form. When liquid aspartame is stored in temperatures above 85 degrees Fahrenheit, itbreaks down into DKP and formaldehyde, both of which are known toxins.
July 8, 1983-- The National Soft Drink Association drafts an objection to the final ruling which permits the use of aspartame in carbonated beverages and syrup bases and requests a hearing on the objections. The association says that Searle has not provided responsible certainty that aspartame and its' degradation products are safe for use in soft drinks.
August 8, 1983-- Consumer Attorney, Jim Turner of the Community Nutrition Institute and Dr. Woodrow Monte, Arizona State University's Director of Food Science and Nutritional Laboratories, file suit with the FDA objecting to aspartame approval based on unresolved safety issues.
September, 1983-- FDA Commissioner Hayes resigns under a cloud of controversy about his taking unauthorized rides aboard a General Foods jet. (General foods is a major customer of NutraSweet) Burson-Marsteller, Searle's public relation firm (which also represented several of NutraSweet's major users), immediately hires Hayes as senior scientific consultant.
Fall 1983-- The first carbonated beverages containing aspartame are sold for public consumption.
November 1984-- Center for Disease Control (CDC) "Evaluation of consumer complaints related to aspartame use." (summary by B. Mullarkey)
November 3, 1987-- U.S. hearing, "NutraSweet: Health and Safety Concerns," Committee on Labor and Human Resources, Senator Howard Metzenbaum, chairman.
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http://groups.yahoo.com/group/aspartameNM/message/857 RTM: www.dorway.com: original documents and long reviews of flaws in aspartame toxicity research 7.31.2 rmforall
http://www.dorway.com/upipart1.txt UPI reporter Gregory Gordon: 96K 3-part expose Oct 1987
"Survey of aspartame studies: correlation of outcome and funding sources," 1998, unpublished: http://www.dorway.com/peerrev.html Walton found 166 separate published studies in the peer reviewed medical literature, which had relevance for questions of human safety. The 74 studies funded by industry all (100%) attested to aspartame's safety, whereas of the 92 non-industry funded studies, 84 (91%) identified a problem. Six of the seven non-industry funded studies that were favorable to aspartame safety were from the FDA, which has a public record that shows a strong pro-industry bias. Ralph G. Walton, MD, Prof. of Clinical Psychology, Northeastern Ohio Universities, College of Medicine, Dept. of Psychiatry, Youngstown, OH 44501, Chairman, The Center for Behavioral Medicine, Northside Medical Center, 500 Gypsy Lane, P.O. Box 240 Youngstown, OH 44501 330-740-3621 rwalton193@aol.com http://www.neoucom.edu/DEPTS/Psychiatry/walton.htm
==
H&W has fda watch: eg Physician Payment
Transparency
Drug manufacturers now subject to sunshine requirements nationwide
18 CONTRACT PHARMA • June 2013 www.contractpharma.com
By Kyle Sampson
Hunton &Williams LLP
chilling effect on industry -dr info conversation ?!
...
This insulting garbage is brought to us courtesy of theWashington Legal Foundation, which, as noted here by SourceWatch, was established in 1977 by Chairman and General Counsel Daniel J. Popeo to "fight activist lawyers, regulators, and intrusive government agencies at the federal and state levels, in the courts and regulatory agencies across the country."
This 1998 interview with Popeo noted that the WLF, at that time, had received about $3 million in contributions from about 500 companies, though the SourceWatch article notes that, between 1985 and 2003, the group has received about $7 million in funding on top of that.
Though Popeo, in the 1998 story, apparently did not like being associated with any coalition or funding source, SourceWatch states that the WLF “sought and obtained funding from Philip Morris and the now defunct Tobacco Institute.” As a result, the WLF has also repeatedly sued government agencies that oversee public health functions, like the Food and Drug Administration and the Environmental Protection Agency, who they sued over workplace smoking policies (decrying what it calls the “junk science” of “anti-tobacco zealots”).
The WLF went after the FDA because of what the group thought was delays in allowing drugs and medical devices to market, and to show the revolving door that exists between the WLF and Bushco, this post notes that Daniel E. Troy effectively landed on the WLF board after leaving Bushco’s FDA, doing his very best to hurt the agency from doing its job to ensure the safety of products under its purview (such as, in particular, Vioxx…as John Mack says, the WLF is to the First Amendment what the NRA is to the Second Amendment, with Troy as the Mike-Brown-FEMA equivalent)....http://liberaldoomsayer.blogspot.com/2007/08/monkeying-around-with-wlf.html
Daniel Troy Legacy: Public Virtually Defenseless against Unsafe Drugs
Thu, 18 Nov 2004
The Associated Press reports that at a Congressional hearing today, Dr. David Graham a drug safety expert at the FDA told the Senate Finance Committee that the public is "virtually defenseless" if another medication such as Vioxx proves unsafe after it has won Food and Drug Administration approval.
"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx." Dr. Graham warned that the arthritis drug had been linked to an increased risk of heart attack and stroke. He also testified that there were at least five other drugs on the market that warrant scrutiny: the acne drug Accutane, the weight loss drug Meridia, the anti-cholesterol drug Crestor, the pain reliever Bextra, and the asthma drug Serevent.
Dr. Sandra Kweder of FDA's office of new drugs, did not agree with Graham's assessment of the risk posed by the five drugs. She said "there is no magic formula" to determine which drugs most raise the most serious safety concerns.
If the FDA would at least monitor MedWatch--its own database of adverse drug event reports - we would not have to wait for a "magic formula."
Dikinson's FDA Webview reports (below) thatDaniel Troy hand-picked Gerald F. Masoudi as his successor as Chief Counsel. Thus, Troy's legacy may not be over. Dickinson and Newsday (excerpt below) provide insight into how the FDA became the permissive lap dog of the food, drug, and cosmetics industry when Troy, a political appointee with long standing ties to industry, ran the agency and methodically downgraded public safety issues.
There are many speculations about what prompted Daniel Troy to resign: perhaps the prospect of having to testify under oath before congressional committees may have influenced his resignation which was announced on Nov 16, effective Nov 28.
There has been growing public criticism of FDA's failure to protect the public from hazardous drugs and the agency's continued failure to monitor drug safety, coupled with the inordinate influence of industry in setting policy. Troy's active intervention on behalf of drug manufacturers in lawsuits filed by individuals who had been harmed by drugs or devices--whose adverse effects were concealed--was a radical departure from FDA policy. Troy's legal argument rested on the infallibility of "FDA's scientific judgment" about safety.
One of the legal briefs submitted by Daniel Troy denied the need for a suicide warning on the drug label. However, FDA's judgments have been shown to be unscientific--inasmuch as crucial safety evidence from clinical trials had been concealed. Industry selectively reported clinical trial results, hiding the adverse findings. When challenged publicly with evidence from antidepressant pediatric trials, the FDA was forced to re-analyze the complete data. Only then did the FDA reach a scientifically valid judgment: Black Box warnings were issued (Oct 15, 2004), acknowledging a causal relation between antidepressants and increased suicide risk.
The basis for Troy's claims rested on scientifically faulty FDA-judgments that had relied on partial - therefore unscientific - information. This demonstrates that entrusting health / safety issues to a single agency is bad public policy. It invites manipulation by powerful stakeholders, undermining rational, science-based health / safety determinations. Neither the FDA nor any of us mortals is infallible; we all prone to errors in judgment.
:{Contact: Vera Hassner Sharav
212-595-8974
}:
:{FDA Webview Reports /Review/Update/DTC Marketer)
FDAers Think Troy Weakened Them, Worry About Masoudi
11/17/2004}:
As chief counsel Daniel E. Troy's impending departure from FDA is being noisily applauded by external critics, it is also being welcomed, quietly, by many program managers inside the agency who say that he has weakened them in meeting new regulatory and scientific public health challenges. And they worry about his apparent successor, raw newcomer Gerald F. Masoudi, who is an unknown factor but who they see as having been hand-picked by Troy.
For example, a high official told us 11/17, in sharply narrowing FDA's traditional broad interpretations of statutory authority, Troy removed many previously effective tools for dealing with complex new issues not addressed in the Food, Drug and Cosmetic Act, such as biotechnology, gene transplants, dietary supplements, health claims for foods and others.
"Of course, Dan would say 'Well, you have tried to interpret the statute in a broad way in the past, and now you've started losing in court,'" this official said. Such court losses - e.g., on the agency'stobacco rule, and a string of First Amendment cases- were seen by Troy as being likely to continue so long as the agency persisted in exercising its traditional broad statutory interpretations, so he set about trimming the agency's sails.
Instead of helping his "client" (FDA management) attain its goals, Troy routinely advised that it lacked statutory authority to reach those goals, this official said. "In writing regulations, we have attempted to put in requirements that might not have been explicitly in the statute, but that we would traditionally have used, be it records authority, or requirements for certain sorts of reporting by a firm. He would say, 'Well, no, you don't have that authority, I'm going to scale that back.'"
One example of this wasTroy's rejection of a CVM plan to regulate genetic transfers in food-producing animals under the new animal drug regulations. CVM protested that the 1938 FD&C Act could not have anticipated gene transfer technology, and that Congress has not been able to deal effectively with this issue,so creative regulation is the only way. "You're putting a compound in a fish or a cow to cause it to grow differently - the scientists think that's essentially the same as putting a drug in the animal," a senior CVM official said. Troy refused to budge.
In a lengthening stream of such narrowing decisions, Troy managed to restrict FDA's ability to use its statutes creatively, and this in turn deterred mid-level managers from advocating new approaches to emerging scientific issues, leaving the agency looking - and feeling - weak. There is a philosophical basis for this result that many see inBush Administration policies: reduce the power of government to "interfere" in the free working of the marketplace.
Troy's past use of forums provided by the ultra-conservative/libertarian Federalist Society and his actions since as chief counsel present a sharp contradiction between FDA's traditional modus operandi and that society's dictum: "The courts must declare the sense of the law; and if they should be disposed to exercise WILL instead of JUDGMENT, the consequences would be the substitution of their pleasure for that of the legislative body." In other words, if FDA did not get from Congress what it needs, it should not try litigation, or regulatory initiatives that might lead to litigation.
There are two ways FDAers look at this posture: (1) Troy was trying to protect the agency from losing any cases in court, and (2) Troy was trying to prevent it from winning any cases in courts that could, in Federalist parlance, legislate from the bench.
Troy's resignation has thrust his apparent choice of successor onto center stage. As expected, HHS general counsel Alex Azar named Masoudi acting chief counsel "until a permanent replacement is appointed," according to an 11/16 statement by acting commissioner Lester Crawford. Informed sources speculated that Masoudi could be that appointee. A 1993 graduate of the University of Chicago Law School, he joined FDA as deputy associate general counsel/deputy chief counsel earlier this month, and did not respond to requests for his biography and an interview.
However, an Internet search revealed that he authored in 1993, University of Chicago Law Review article, Kosher Food Regulation and the Religion Clause of the First Amendment, which has since become very widely referenced on various legal Web sites and by other scholars.
At Kirkland & Ellis, whose Web site no longer mentions him, he was one of four attorneys who in 1999 sued three cable Internet companies for client GTE in Western Pennsylvania federal court alleging Sherman Antitrust Act violations in the bundling of high-speed cable data transport services. In 2001, he represented the H.J. Heinz Co. in defending against a Federal Trade Commission suit that sought to block a proposed merger between Heinz and Beech-Nut Foods.
One of Masoudi's most recent cases at Kirkland & Ellis involved a rate-regulation case this year before the Louisiana Public Service Commission in which he represented Arkansas Electric Energy Consumers, Inc.
Meanwhile, outside critics of Troy have raised their rhetoric against him. In a public e-mail to acting commissioner Lester Crawford 11/17, Alliance for Human Research Protection director Vera Hassner Sharav charged that Troy "was a symbol of what is rotten at the FDA: the pharmaceutical industry's influence has ensured that business interests take precedence over public safety.
"Industry-influenced advisory committees," she continued, "have led to the approval of lethal drugs that were widely marketed until the death toll became publicly known. Troy actively intervened on behalf of pharmaceutical companies in civil cases brought by individuals who sought justice in the court. Let us hope that other senior FDA officials who have similarly disregarded their role as public servants and have shielded drug manufacturers who concealed the hazardous effects of their products, resulting in preventable deaths, will resign as well.
"The FDA has been derailed from its mission, which is to ensure that the public is protected from unsafe and ineffective drugs, and that physicians and the public rare provided scientifically accurate information.
"Whereas Troy intervened on behalf of pharmaceutical companies claiming that the FDA's authority pre-empted all others in matters of drug safety - even when they concealed lethal drug effects - New York State Attorney General, Eliot Spitzer, brought action against GlaxoSmithKline, charging the company with fraudulent marketing of Paxil (seroxat). That action undermined Troy's pre-emption authority argument - and ultimately undermined his standing.
"In light of the skyrocketing expenditures for prescription drugs - U.S. consumers spent $216 billion on prescription drugs last year, up 11.5% in a year (according to IMS Health) - Dr. Lester Crawford's claim that Daniel Troy's 'reforms' saved consumers $35 billion, is not credible." Meanwhile, Rep. Maurice Hinchey (D-NY), who has had several policy run-ins with Troy, said 11/16 the resignation announcement (see earlier story) "is a rare bright spot in what has been a dark period for FDA." According to Hinchey, Troy worked tirelessly to weaken FDA's ability to face challenges such as the withdrawal of Vioxx and the flu vaccine shortage. "Under Troy's direction," he said, "the agency has argued in court that manufacturers, some of whom he represented in private practice, should not be held responsible if their products injure customers. He wasted precious taxpayer dollars on other personal ideological pursuits as well. Instead of working to strengthen FDA's mandated role as a guardian of public health, Troy has made it the agency's mission to protect corporate profits." Hinchey called on Crawford to "return FDA to its appropriate mission... by removing politics from the chief counsel's office and appointing a career civil servant" as Troy's replacement.
:{http://www.newsday.com/news/politics/ny-usfda114002814oct11,0,5464956,print.story
NEWSDAY
ERASING THE RULES Industry has some friends on the inside
Bush-appointed administrators at the FDA have consistently sided with the interests of business
BY THOMAS FRANK
October 11, 2004}:
Two years ago, California walnut growers conceived the perfect promotion: put labels on packages saying walnut consumption reduces the risk of heart disease.
There was one problem.
The Food and Drug Administration demanded substantial evidence to allow such claims, and it found that studies the growers touted were "of poor to moderate quality" or "not directly relevant."
Even three outside experts the FDA hired said a link between walnuts and heart disease was "uncertain."
But then the agency relaxed its standards. And on March 9, it reached an unprecedented decision: Labels could claim that walnuts "may" reduce heart-disease risk while noting that research was "not conclusive."
The eased standards were long sought by the food industry, which found key allies in the Bush administration FDA. Top appointees who once advocated for FDA-regulated industries have heeded industry lobbying in ways that medical groups and consumer advocates say jeopardize public health.
After food-industry groups complained, a top appointee killed a measure to discourage consuming a cholesterol-raising fat. Plans to eliminate misleading sunscreen labels have been tabled following cosmetics-industry complaints. A post-Sept. 11 plan to help contain food contamination is nearly a year late as food-processing groups have objected.
Letters directing drug companies to stop false or misleading ads are reduced and delayed under new policy that some critics say increases the public's exposure to misinformation.
In a dramatic legal novelty, the FDA has intervened for manufacturers in lawsuits, urging courts to dismiss damages claims against them. FDA briefs have helped the world's two largest drug companies win product-liability cases.
The FDA says courts are not equipped to judge a product's safety. On regulation, officials say their position reflects court rulings that warn about restricting commercial speech. Allowing inconclusive health claims on food labels such as walnuts gives consumers more information, the agency says.
"Naturally, our approach to enforcement may evolve as we adapt to new FDA legal authorities or evolving science and technology," the FDA said in a recent statement. "But the goal of judicious enforcement of the law, to fulfill our mission of promoting and protecting the public health, remains constant."
The walnut industry is already profiting from the new labels that will start next year. Walnut processing giant Diamond of California says publicity about them has helped lift sales 30 percent over last year.
But the American Medical Association said consumers may be duped. The walnut claims "have a reasonable chance of being erroneous," it said. "An educated consumer will not know whether to believe or not to believe the claim."
Rep. Henry Waxman (D-Calif.) wrote the 1991 law requiring "substantial scientific evidence" for health claims. "Congress didn't want food manufacturers to make claims without substantiation," he said. "The clear language of the statute is just being ignored."
The influence behind many FDA decisions is chief counsel Daniel Troy, who was a sharp critic of the agency before President George W. Bush put him in charge of its legal affairs.
A Queens-born Columbia Law School standout, Troy, 44, came to the FDA primed for activism: Clerk for conservative icon Robert Bork; partner at blue-chip Wiley, Rein & Fielding; scholar at the pro-business American Enterprise Institute; litigant for the anti-regulatory Washington Legal Foundation.
Representing a tobacco company against the FDA in the late 1990s, Troy helped win a landmark Supreme Court ruling blocking the agency's attempt to regulate tobacco products.
Litigating for the legal foundation, which drug-company foundations help fund, Troy challenged the FDA's restrictions on promoting drugs for uses the FDA has not approved.
The policy, Troy wrote in 1999, reflects "an overzealous FDA."
Appointed in August, 2001, Troy had vast authority. With no FDA commissioner until November 2002, Troy reigned for more than a year as top administrator in an agency that regulates 22 percent of the U.S. economy.
"He sent a signal to companies that if you want to deal with the FDA on a number of issues, he's the man to see," said a senior FDA official.
In three years, Troy has held 129 meetings with lobbyists and others with issues before the FDA.
Mark McClellan, commissioner from October 2002 to March 2004, held 30 such meetings, FDA records show.
From 1998 to 2001, Troy's predecessor, Margaret Porter, held one meeting.
"She did not directly interact with industry," said Jane Henney, FDA commissioner in 1999 and 2000. "She felt those interactions were done by the staff, and [lobbyists] should make their case to them."
But the Bush administration made the chief counsel a political appointee for the first time since the 1980s, easing out civil-servant Porter and empowering Troy.
At the end of a meeting with cosmetics-industry officials two months into his job, Troy decided to delay indefinitely sunscreen regulations the industry opposed.
"We asked them to put it off. They've done what we asked," said Tom Donegan, general counsel of the Cosmetic, Toiletry and Fragrance Association.
Donegan's group opposed a proposed ban on sun-protection factors higher than 30, which the FDA found provided "extremely small" amounts of extra protection. Donegan told Troy the ban raised free-speech issues.
"He's very receptive," Donegan said.
The regulations, developed after 21 years of study and debate, also would have banned from sunscreen labels starting in 2003 terms such as "sunblock" and "waterproof," which it determined were "misleading" and "unsupported." Their use remains common.
Food-industry officials got Troy's help after a National Academy of Sciences study requested by the FDA recommended "trans fat consumption be as low as possible" because it raised cholesterol. The FDA wanted that statement on food labels starting in 2006.
Industry officials who met Troy said the label may violate the First Amendment and could lead consumers and food processors to substitute similarly harmful saturated fat for trans fat.
Xxxcut xxx
2004, Newsday, Inc.
Tobacco Enemy Number One
Gingrich calls Kessler "a bully and a thug." Dole has pledged to fire him. When you look behind these attacks, says one top FDA official, "you will see the tobacco industry."
By Robert Dreyfuss | Tue Apr. 30, 1996 11:00 PM PDT
Ever since the Republican takeover of Congress in November 1994, the Food and Drug Administration has been under fire from critics on the right who claim the agency is slow to approve lifesaving drugs and medical devices. Newt Gingrich has calledFDA Commissioner David Kessler "a bully and a thug." The conservative Washington Legal Foundation runs ads that say: "If the FDA kills you, it's just being cautious." Similarly, Citizens for a Sound Economy, an anti-tax group, sponsors ads claiming, "A better quality of life--even life itself--is being denied to too many Americans because of the FDA's misplaced priorities."
Meanwhile, the Competitive Enterprise Institute, a right-wing think tank, has put forward a radical plan that would end the FDA's power to veto new drugs and medical devices. Gingrich's own Progress & Freedom Foundation has likewise recommended "replacing" the FDA with a private drug-approval system. Following their lead, Republicans in both the House and Senate have introduced legislation to reduce the FDA's regulatory authority.
Yet, for the most part, these proposals are far more radical than any called for by drug and medical device manufacturers--the supposed beneficiaries of a scaled-down FDA. Tom Lenard, the Progress & Freedom Foundation's director of regulatory studies, puts it bluntly, "The drug companies are not particularly radical. Our proposal is beyond where most of them seem to want to go."
A top FDA official concurs: "The drug companies are happier than they have been in 10 years." In fact, changes instituted by Kessler over the last five years have actually cut approval time by 30 to 40 percent.
Nor are medical device manufacturers driving the attack against the federal agency. "The device industry doesn't want to see the FDA go away or be weakened," says Jim Benson, senior vice president of the Health Industry Manufacturers Association.
So where is the pressure to gut the FDA coming from? "If you look at the people who are pushing for reform of the FDA," says one FDA official, "behind the scenes you will see the tobacco industry."
W H A T ' S A T S T A K EThe clock is now ticking down toward a summer showdown between the tobacco industry and the FDA. With the FDA set to unveil a precedent-shattering rule that defines the nicotine in tobacco as a drug and sets strict controls over its sale and advertising, the $45 billion tobacco industry is waging a life-or-death struggle to preserve its unfettered right to sell cigarettes and chewing tobacco.
The stakes are immense. The FDA's proposal could be the beginning of the end for the American tobacco industry. Already, the disorder in tobacco's ranks led the Liggett Group, the nation's fifth-largest tobacco company, to make a stunning break with the rest of the industry. In March, Liggett settled a range of lawsuits over the health impact of smoking--the first time any tobacco company has consented to pay damages--and agreed to abide by some proposed FDA tobacco marketing regulations.
For the Clinton administration, the battle with tobacco means an election-year showdown with what a key congressional aide calls "the most powerful special interest in America," one that has forged a close alliance with the Republican leadership and its putative presidential nominee, Senate Majority Leader Bob Dole.
T H E F D A T A K E S O N T O B A C C O
On August 10, 1995, President Bill Clinton made a historic announcement: The FDA proposed to make a rule, probably by the summer of 1996, regulating the nicotine in tobacco as a drug.
Unlike other efforts to control tobacco use--higher taxes, restrictions on smoking in restaurants, etc.--the FDA's proposed action represents a fundamental challenge to the very existence of the tobacco industry, which has maintained for nearly 100 years that tobacco is neither food, drug, nor cosmetic, and is therefore not subject to regulation.
The FDA based its decision on three landmark conclusions that strike at the very heart of the tobacco industry:
- Nicotine is addictive and has other pharmacological effects on the structure and function of the body.
- Tobacco manufacturers know consumers use tobacco for the pharmacological effects of nicotine.
- Nicotine meets the legal definition of a "drug" because tobacco manufacturers "intend their products to have these effects" and manipulate nicotine levels to ensure they do.
In an October speech in Memphis, Tennessee, Kessler detailed the effort that led to the FDA's conclusions. "Our first clue...came from a search of the industry's patents," he said. The patents contained extensive research on ways the tobacco companies could control the precise amount of nicotine in their products. The industry could raise the content of addictive nicotine by carefully selecting which parts of the tobacco plant to use and by developing certain strains of tobacco leaves. One such effort uncovered by the FDA was Brown & Williamson's Brazilian patent, written in Portuguese, for a plant called "Y-1 tobacco" that had twice the usual nicotine content. Finding shipments of Y-1, said Kessler, "was like finding a needle in a haystack."
Other evidence compiled by the FDA concerned the chemical additives tobacco companies use to increase the amount of nicotine absorbed by the smoker. For example, an industry handbook acquired by the agency described how companies use ammonia to increase the absorption of nicotine into the lungs.
The FDA combined its scientific evidence with unambiguous statements by industry insiders that tobacco companies design cigarettes to hook consumers on the addictive power of nicotine. (The FDA quoted one tobacco industry official who said, "Think of the cigarette pack as a storage container for a day's supply of nicotine. Think of the cigarette as a dispenser for a dose unit of nicotine. Think of a puff of smoke as the vehicle for nicotine.")
Bolstered by this mountain of evidence, the FDA proposed to define nicotine as a drug, and regulate cigarettes as "drug-delivery devices." Specifically, the FDA proposed restricting the sale of tobacco to minors (see "Joe Camel's Tracks" [1]).
Backed by the White House and the Department of Health and Human Services, the FDA proposed to require age verification and face-to-face sales for tobacco products, eliminating all mail-order and vending machine sales. To reduce tobacco's appeal to kids, the FDA also proposed banning billboards that promote tobacco near schools; limiting tobacco advertising to black-and-white text in magazines that have a "significant youth readership"; forbidding tobacco-brand logos on teen-oriented products like caps and gym bags; and prohibiting brand-name sponsorship of sporting events, races, and concerts.
T O B A C C O C O U N T E R A T T A C K
The tobacco industry was prepared for the FDA action. "Prior to December 1993, they may well have been caught by surprise," says a senior FDA official, "but by February '94, they knew we were serious." As soon as the FDA made its announcement, the five largest tobacco companies (Philip Morris, R.J. Reynolds, Lorillard, Brown & Williamson, and Liggett) launched a massive lawsuit challenging the FDA's authority to govern tobacco. (As Mother Jones went to press, Liggett was still part of the FDA lawsuit despite speculation it would drop out.)
In record time, the industry prepared a 2,000-page legal reply to the FDA's announcement, with 45,000 pages of supporting documents. "It is mind-boggling that the tobacco industry was able to assemble this response so quickly," says an attorney close to the FDA. "They must have had countless lawyers working on this."
Some of those lawyers may themselves be former FDA attorneys. Over the years, the tobacco industry has assembled a legal team that includes five former FDA general counsels or deputy counsels. "It is astonishing. These lawyers are the experts in the field, and they know where everything is buried at FDA," says an FDA official. "When they talk to their clients, they say, 'Ask for this document,' and they know about the document because they are the ones who wrote it."
T H E H I D D E N W A R A G A I N S T T H E F D A
The tobacco industry hasn't confined its counteroffensive against the FDA to the courts. "Quietly, behind the scenes, the industry is helping to support a much broader attack on the FDA," says Cliff Douglas, a longtime anti-tobacco activist.
The attack has three major components:
- The industry has provided generous support to a host of Washington think tanks and advocacy groups that have led the effort to gut the FDA. The Competitive Enterprise Institute, for example, has received $50,000 to $100,000 or more from tobacco companies, according to the group's general counsel, Sam Kazman. Tobacco has also contributed hundreds of thousands of dollars to Citizens for a Sound Economy, and has made substantial donations to Gingrich's Progress & Freedom Foundation and the Washington Legal Foundation.
- Tobacco companies have directed a massive letter-writing campaign against the FDA. Between the FDA's August 1995 decision to regulate tobacco as a drug and January 1996, when the official period for public comment on the plan ended, the agency received nearly 700,000 pieces of mail overwhelmingly condemning the FDA's stance on tobacco. The avalanche of mail was the result of an emergency push by Philip Morris, R.J. Reynolds, and The Tobacco Institute to create the impression of a citizens' uprising against the FDA, but most of it was organized, funded, and even written by the tobacco companies. It is widely seen as an effort to intimidate Washington. "The tobacco companies think it will have some psychological effect on the FDA, on the courts, and on Congress," says Alan Morrison, an attorney with the consumer advocacy group Public Citizen. "These guys are used to sparing no expense. This is war."
- As it became clear that Clinton's FDA was going after them, the tobacco companies shifted their political support--traditionally bipartisan--to the Republicans. In 1993-94, the industry contributed an unprecedented $1.8 million in soft money to the GOP takeover of the House and Senate. Not only did the victory defang Democratic members of Congress who had harried the industry for decades, it also catapulted friends of tobacco into positions of power. Rep. Thomas J. Bliley Jr. (R-Va.), the new head of the Commerce Committee, wasted little time announcing an end to all congressional investigations into tobacco.
Other tobacco allies on Capitol Hill are less visible. Alan Slobodin, a lawyer at the Washington Legal Foundation before the Republican landslide, now is counsel to the Commerce Committee's Subcommittee on Oversight and Investigations, which has jurisdiction over the FDA. In his new post, Slobodin wages an unrelenting campaign against the agency, holding innumerable hearings and draining agency resources with his demands for documents and testimony. "Slobodin is constantly saying, 'Give us all your documents on this or that,'" says an attorney close to the FDA. "And then all of a sudden these papers show up in the hands of the Washington Legal Foundation."
So far, tobacco companies have not pressed their allies in Congress for legislation that would undermine the FDA's nicotine policy. Sources on both sides say the companies are unlikely to do so until after the industry's lawsuit against the FDA is decided. Part of the reason is that any effort to restrain the FDA through new legislation would lend credibility to the idea that the FDA does indeed have the power to regulate tobacco. Further, despite its alliance with the GOP leadership and a few key Democrats in Congress, the industry would find it difficult to raise majorities in both houses for a bill overturning the FDA's nicotine proposal, let alone gather enough votes to override a certain White House veto. For these reasons, Big Tobacco has thus far used its congressional influence primarily to intimidate the White House and the FDA.
In December, 124 members of the House sent a sharply worded letter to the FDA, claiming the agency's tobacco proposal would put 10,000 jobs at risk and "trample First Amendment rights to advertise legal products to adults." Two weeks later, 32 senators signed a virtually identical letter. (According to Common Cause, those senators who signed the letter had received an average of $31,368 from tobacco, compared to $11,819 for those senators who did not sign. Similarly, the House signatories received an average of $19,446, in contrast to $6,728 for other Congress members.)
T H E C O M I N G B A T T L E
The FDA has moved rapidly on its proposal to regulate nicotine. Though FDA officials will not predict exactly when the final rule will be announced, sources close to the agency say that it is likely by early summer. In March, the FDA stunned Philip Morris--and the rest of the industry--by releasing three devastating statements by former Philip Morris employees, stating that the company routinely manipulated nicotine levels in its products. These three statements were so important that the FDA took the unusual step of reopening the period for public comment on the proposed rule for another 30-day period, though the extension is not expected to cause any delay in the FDA's push to issue its final rule by this summer. "This is information that we believe the public should know," said Kessler in releasing the statement. "These documents shed light on the role of nicotine in the design and manufacture of cigarettes."
Though the industry has already challenged the FDA in court, it could be months before the judge in the case takes any action. In going to court, the industry chose the most friendly venue it could find, the Federal Middle District Court in Greensboro, North Carolina, in the heart of tobacco country. The judge in the case, William L. Osteen Sr., once worked as a lobbyist for the tobacco industry. In 1994, he delivered a ruling favorable to tobacco in a case involving the Environmental Protection Agency and secondhand smoke.
But anti-tobacco activists say that initial signs from the judge do not show obvious favoritism toward the tobacco industry. And despite the industry's urgency in pressing its legal argument, Osteen probably won't act before the FDA issues its rule. The FDA, in turn, intends to craft its rule with built-in waiting periods for the various provisions to take effect, in order to give the industry adequate time to comply.
That means the FDA's anti-tobacco rule will be an issue throughout the presidential election. President Clinton strongly backs Commissioner Kessler. He even traveled to Kentucky the day after his January State of the Union address to reaffirm the White House's support. But, if elected, President Dole would be certain to fire Kessler as one of his first actions in the Oval Office. Conceivably, a Dole-appointed FDA commissioner might reverse the FDA's anti- nicotine rule, though doing so would be politically explosive.
For now, the U.S. tobacco industry is on the defensive. The Liggett Group's controversial decision to settle and to comply with some of the FDA's proposed regulations rocked Philip Morris and RJR Nabisco. In just a week, the value of their companies on the New York Stock Exchange dropped by nearly one-sixth. Though it is just the first break in tobacco's ranks, Liggett's move signals the industry's potential vulnerability to the combined assaults from the FDA, the Justice Department, and a host of consumer injury cases piling up in the courts. "It's like a murder case," says Phil Schiliro, chief of staff for Rep. Henry Waxman (D-Ca.). "You have five people accused of murder and one of them tries to get a break by cutting a deal with the D.A. Now maybe one or two more may start talking. Who knows where this will end?"
Indeed, anti-tobacco activists do not yet know the full ramifications of the Liggett Group's settlement. But it makes their job easier. "At least it allows us to say to members of Congress, 'Look, the fifth-largest tobacco company has said that these regulations are reasonable,'" says Phil Wilbur of the Advocacy Institute. "'How can you as a member of Congress disagree?'"
Robert Dreyfuss is a contributing writer to Mother Jones. He co-authored the "Medikill" [2] story on Golden Rule Insurance that appeared in our January/February 1996 issue.
Source URL: http://www.motherjones.com/politics/1996/05/tobacco-enemy-number-one
Links:
[1] http://www.motherjones.com/news/special_reports/1996/05/dreyfuss2.html
[2] http://www.motherjones.com/news/feature/1996/01/medikill.html