FDA against Raw Milk, they want DEAD FOOD, no enzymes

Special FDA agents and investigators from the U.S. Food and Drug Administration aggressively interrogated two young female employees of Organic Pastures Dairy Company, the nation's largest raw milk producer, with questions focusing on the dairy's interstate sales of raw colostrum and raw milk for pet food.

The surprise interrogations took place after work in their private homes on the evening of March 19, just hours after Judge Tobias of the Hollister Superior Court issued a temporary restraining order against the California Department of Food and Agriculture. The state court ruling blocked enforcement of California's anti-raw milk AB 1735, which mandates unnecessarily stringent standards for beneficial coliform bacteria in raw milk. The temporary restraining order represents an important legal victory for raw milk producers and consumers in California and throughout the nation.

The federal agents threatened one employee with arrest if questions were not fully and truthfully answered about Organic Pastures' order fulfillment practices. Her answers reflected information that is readily available at the company's website, www.organicpastures.com. The other employee was told FDA would "make it worth her while" to "wear a wire" and record conversations with Organic Pastures president Mark McAfee. The employee refused the offer. "We are like a family, I would never do that to a family member," she said, reflecting her close relationship with the McAfee family.

Both employees were served subpoenas to appear April 3 for a secret grand jury investigation. In 2003, Organic Pastures received a confirmation letter from Larry Childers of the FDA, which clearly stated that interstate sales of raw colostrum are not regulated because colostrum is not milk. The FDA website notes that "pet food" requires no pre-market approval and is unregulated by the FDA.

The Bronx Zoo in New York and other zoos regularly order raw colostrum and raw dairy products from Organic Pastures to save babies of endangered species and keep other animals healthy. Orders stipulate that the milk and colostrum must be raw because pasteurized versions make them ill. Many veterinarians recommend raw milk for cats and dogs.

"FDA has gone on the record as 'hating raw milk' in any form," says Mark McAfee, founder and president of Organic Pastures. "The harassment of our employees and grand jury investigation is just the latest round in the government vendetta against Nature's perfect food. If Organic Pastures is doing something illegal, all FDA needs to do is come and tell us and we will make the necessary changes to our labels and procedures."

Organic Pastures will be represented in this action by the Farm-to-Consumer Legal Defense Fund. Membership in the Fund helps support the defense of raw milk and direct farm-to-consumer sales. For further information visit www.ftcldf.org.

FDA Tries to Justify High Levels of Contaminants in Infant Formula

The FDA has admitted that it based its determination that current levels of bisphenol-A (BPA) exposure pose no health risks on two studies sponsored by the American Plastics Council, the trade group that represents BPA manufacturers.

One of these studies has been found to be deeply flawed, and the other study has not been published and its results have not been made public. The FDA chose to ignore data from almost 100 independent, peer-reviewed, and published animal studies that show that BPA is toxic at very low levels of exposure. Many of these independent studies were funded by the National Institutes of Health.

BPA is used in a number of different plastic products, including baby bottles.

FDA Quietly Acknowledges the Medical Benefits of Honey

The U.S. FDA has quietly approved a line of honey-based wound dressings. Although using honey to treat wounds is nothing new, it is a practice often relegated to "folk healing".

In fact, honey has antibacterial properties, and it produces its own hydrogen peroxide when combined with the fluid which drains from a wound. It also draws the pus and fluid from the wound, speeding the healing process.

Honey has been accepted by the overseas mainstream medical community for some time, and it looks like the U.S. has finally caught on.

The FDA has agreed to put Merck’s application for expanded approval of Gardasil

The FDA has agreed to put Merck’s application for expanded approval of Gardasil, a cervical cancer vaccine, on the fast track. It is already approved for women and girls ages 9 through 26, and the expansion would allow it for use in women ages 27 through 45.

The FDA’s decision has disturbed many people who are concerned over the high number of side effects reported in relationship to Gardasil. A 2007 analysis revealed that there had been at least 3,461 complaints of adverse reactions to the Gardasil vaccine, and there could have been as many as eight deaths attributable to Gardasil.

Gardasil side effect reports include blood clots, miscarriages, paralysis, Bells Palsy, Guillain-Barre Syndrome, and seizures. Despite this, Merck continues to market Gardasil as virtually side-effect free, and the FDA has thus far refused to conduct a formal safety review of Gardasil.

How Drug Companies Covertly Influence the Content of Medical Literature

April 16, 2008 by: David Gutierrez
Pharmaceutical companies regularly carry out every aspect of a study on their products, then solicit academics to put their names on the final papers in order to disguise their involvement, according to an essay published in the journal PLoS Medicine. Author Sergio Sismondo calls this practice "ghost management," to distinguish it from mere ghost writing.

"In extreme cases, drug companies pay for trials by contract research organizations (CROs), analyze the data in-house, have professionals write manuscripts, ask academics to serve as authors of those manuscripts, and pay communication companies to shepherd them through publication in the best journals," Sismondo writes. "The resulting articles affect the conclusions found in the medical literature, and are used in promoting drugs to doctors."

Sismondo points to a study conducted by David Healy and Dinah Cattell, who analyzed Pfizer's involvement in managing studies on its product Sertraline. The researchers uncovered that through a CRO, Pfizer was keeping careful track of these studies from planning to publication. The articles managed by Pfizer comprised between 18 and 40 percent of all articles published on the drug between 1998 and 2000.

These articles were universally positive about the drug and under-reported its side effects. They were also published in more prestigious journals and were cited nearly three times as frequently as more critical articles not managed by the company.

Ghost management has become such a huge industry that a professional association has even been established for it -- the International Publication Planning Association.

Sismondo notes that while Healy and Cattell looked at only one drug, the evidence suggests that ghost management is widespread. When it was revealed that a journal article on Merck's drug Vioxx had failed to mention the deaths of certain participants, for example, lead author Jeffrey Lisse pleaded innoncence: "Merck designed the trial, paid for the trial, ran the trial," Lisse said. "Merck came to me after the study was completed and said, 'We want your help to work on the paper.' The initial paper was written at Merck, and then it was sent to me for editing."

Why the FDA doesn't want to regulate tobacco

A proposed law that would give the FDA the authority to regulate tobacco products have garnered a wide degree of support -- including from Philip Morris, the world's largest tobacco company.

The Family Smoking Prevention and Tobacco Regulation Act would give the FDA the same authority to regulate tobacco products that it currently has to regulate foods, drugs and medical devices. This means that the FDA would be responsible for approving all new tobacco products (but not products already on the market) and for regulating the levels of harmful ingredients in tobacco products and smoke.

Cigarette smoke contains an estimated 4,000 chemicals, and more than 40 have been identified as carcinogens.

The act would also strengthen the health warnings on tobacco products and prohibit the use of false claims in marketing, including "light" and "low tar." It would place stricter restrictions on the advertising of tobacco products.

According to some critics, it is this last clause that has led Philip Morris to support the proposed law. "If you make it more difficult to communicate with smokers, and you have half the market, it results in the market share getting locked in," said John W. Singleton, director of communication for Reynolds American, Inc., the second largest tobacco company in the United States. "If you get locked in at 50 percent, that's pretty good. The bill gives Phillip Morris a competitive advantage."

Cigarette brands produced by Reynolds American subsidiaries include Camel, Kool, Pall Mall, Salem and Winston.

Philip Morris subsidiary Philip Morris USA is the largest tobacco producer in the United States, controlling 50 percent of the consumer market. Philip Morris brands include Marlboro, the most popular cigarette brand in the world.

According to Philip Morris USA President Howard Willard, the company supports the proposed law because FDA regulation of tobacco products has been called for by the U.S. Institute of Medicine.

Why would Big Tobacco support regulation of tobacco?
Rival tobacco companies are not the only ones skeptical of Philip Morris' motivations. According to Stanton A. Glantz, director of the Center for Tobacco Control Research and Education at the University of California-San Francisco, the company's support was one of the main factors that convinced him to oppose it.

"I remain skeptical of the bill, because it's basically going to benefit Philip Morris," Glantz said. "I think that the FDA should have control over tobacco, but not on terms that Philip Morris wrote. I think that the people who are supporting this bill will live to regret it."

The House version of the bill already has 200 sponsors, while the Senate version has 55. According to Mathew L. Myers, president of the nonprofit Campaign for Tobacco Free-Kids, more than 500 public advocacy groups are also supporting the proposed law.

Why the FDA doesn't want to regulate tobacco
But the call for FDA regulation is being vigorously opposed by the agency itself, which insists that it is ill-equipped to regulate tobacco products.

Because the FDA's role is to regulate products that are beneficial to public health, it cannot be asked to regulate products that are harmful, said FDA chief Dr. Andrew C. von Eschenbach. The act "would ask us to apply this [public health] framework to tobacco products that, when used as intended, produce disease rather than promote health. FDA cannot 'approve' a tobacco product in this context, because there is no scientific context to determine benefit to outweigh the numerous risks."

Giving tobacco products the seal of FDA approval might mislead consumers into thinking that those products are safe or even good for their health, von Eschenbach said. In addition, the agency does not have the financial or staff resources that would be required to regulate the giant tobacco industry.

AMA gives Lucky Charms a Heart-healthy seal on Approval!

The FDA actually approved the following health claim for Mazola Corn Oil, a product very high in the omega-6 fatty acids that most Americans get way too much of:

Very limited and preliminary scientific evidence suggests that eating about a tablespoon of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil.

Of course, if you continue reading, you see the "qualification" of this health claim:

[The] FDA concludes that there is little scientific evidence supporting this claim.

And then, to make it more head-smacking confusing:

To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day.

I don't know if the aforementioned example proves the FDA is corrupt or just stupid. It appears to be clear, though, that the American Heart Association is corrupt.

Consider that they've bestowed (for a fee) their heart-healthy seal on Lucky Charms, Trix, and Cocoa Puff cereals, in addition to Yoo-hoo Chocolate Drink, and Healthy Choice's Caramel Swirl Ice Cream.

Similar degrees of chutzpah are evident in the countless food manufacturers who claim their product to be chock full of antioxidants. Keep this in mind: all plants contain antioxidants of some kind, so don't think for a minute that the people who make Snickers Bars (which contain cacao from plants) haven't considered slapping a "Rich With Antioxidants!" label on their product.

Meanwhile, the products that truly contain rich amounts of antioxidants — the fresh fruits and vegetables in the produce aisle — have no label to trumpet their nutritional value.

Michael Pollan Omnivore's Dilemma

Our modern-day Upton Sinclair is a journalism professor named Michael Pollan whose book, The Omnivore's Dilemma, explored the American food manufacturing system. The book's most significant contribution was the assertion that a combination of political and biological factors had done almost indescribable damage to the overall health of Americans.

Specifically, he traced how a single political decision made in the 70's having to do with farm subsidies led to a single grain — corn — being mass grown without the limitations normally imposed by supply and demand.

Corn became so abundant and consequently so cheap that manufacturers began looking for novel ways to use it. This led to the inclusion of high-fructose corn syrup in hundreds of products and the invention of a dazzling array of corn-based cereals and snack foods.

With all those cheap, salted, and sugared calories to be had, Americans grew increasingly fat and increasingly diabetic. Perhaps worse, though, was the wide-spread use of corn as cattle feed.

Cattle don't do well on grains. It makes them sick and they then require antibiotics. Furthermore, it changed the fatty acid content of their meat. Whereas normally the grass-fed creatures had omega-6/omega-3 fatty acid ratios more consistent with wild game or wild salmon, the corn-feeding turned them into hoofed heart attacks in waiting, the ingestion of which slowly clogged the nation's arteries.

Despite the billion-lumen light Pollan shined on the food industry, he didn't really pontificate too much on what humans should eat. He attempts to rectify that with his latest book, In Defense of Food.

Upton Sinclair - Book "The Jungle" --> FDA creation

He wrote about how dead rats were shoveled into sausage grinding machines. He explained, in nauseating detail, how diseased cows were slaughtered for beef; how guts and garbage were swept off the floor and sold as "potted ham."

Upton Sinclair even described how the occasional worker would fall into a meat-processing tank and be ground, along with animal parts, into "Durham's Pure Leaf Lard."

The Chicago meat-packing industry was in deep trouble after Sinclair's landmark book, The Jungle, was published in 1906. It caused outrage in America and abroad and meat sales fell by half. The book forced the government to pass the Meat Inspection Act and the Pure Food and Drug Act, which established the Food and Drug Administration.
The Jungle

Aspartame soon to be banned. Hawaii is trying!

Walking down the isles of your local supermarket, it is difficult to pick up any one item that does not contain aspartame. Without actually reading the ingredient list, consumers are led to believe that labels touting, "No Sugar Added", "Low Sugar", or "Sugar-Free" are actually healthy no sugar alternatives, when in truth; most items that carry such labels contain chemical sweeteners such as aspartame or sucralose that are far from "healthy".

Consumption of aspartame can be linked to arthritis, Fibromyalgia, Multiple Sclerosis, Lupus, insomnia, headaches/migraines, dizziness, and loss of vision just to name a few.

Now, one state has joined in the fight to have one of these chemicals removed from the food supply. Hawaii is making strides toward legislation that would ban aspartame from the food on Hawaiian store shelves. They are the second state to craft legislation geared toward aspartame removal.

In 2006, New Mexico attempted legislation that would have effectively put a halt to what some have labeled, "Rumsfeld's Disease", named appropriately after aspartame's chief champion in the 1970's, Defense Secretary Donald Rumsfeld. The lobbyists and corporations went to testify and according to Stephen Fox, who petitioned to push the bill into legislation, Richard Minzner, former Majority Leader in the House, told the Committee that it was, "irresponsible and illegal to even think about challenging an FDA approved chemical." Stephen reported that not one committee member objected to this statement. They simply sat listening as they ate their ham sandwiches and downed cans of diet soda.

Hawaii took up the gauntlet in late January to try their hand at a ban on the toxic substance. Today, that bill was killed in Committee for the entire 2008 session.

It was decided that instead of bringing this Hawaii House bill to a vote, which is what Representative Josh Green, M.D., told his constituents that he would do last week, he has "deferred at the discretion of the Chair". According to Stephen Fox, there is still a bill to be considered by the Senate, but with over 3000 other bills in consideration, the Senate bill to ban aspartame has, "yet to be scheduled for its hearing."

Awareness regarding the dangers of aspartame seems to be increasing even though the FDA, corporations, and some doctors insist on its safety.

Dr. Kalani Brady, a physician at John A. Burns School of Medicine says, "Aspartame has been studied hundreds of times. Nothing has ever been shown to be a detriment with aspartame. It's perfectly safe."

Dr. Brady insists that a ban on aspartame would have an adverse affect on life as we know it. "Oh, we would shut things down, you know. It's very difficult to look into all the products that aspartame is contained in. More than just an inconvenience, it would shut down the economy."

On February 12, 2008, ABC aired a piece with Diane Sawyer regarding new research from Purdue University in the field of aspartame dangers.

Dr. Marie Savard tells us that as little as one diet soda a day can change your metabolism and actually cause you to gain weight. She also reported that consumption of artificial sweeteners can change brain chemistry.

The artificial sweetener industry issued a response in regard to the new research information. The Calorie Control Council rebutted the study saying, "Previous studies in humans have shown that low calorie sweeteners are indeed beneficial for weight control."

Dr. Savard tells us in this interview that there have been "small studies" showing benefits, but two recent large studies involving 18,000 participants that were followed for five to nine years found "healthy adult people consuming as little as one diet drink a day could increase the risk of Metabolic Syndrome, pre-heart disease, and weight gain by 30-40%."

Researchers are not certain if the brain will "reset" once the artificial sweeteners such as aspartame are stopped or at least lessened to less than one a day. They admit that more research is needed.

You can see this interview here: (http://www.youtube.com/watch?v=P5tpCpqABhM) .

Aspartame is the one substance that receives the most complaints to the FDA and yet it remains on the market. The FDA stopped tabulating complaints on aspartame in 1992 after the tally had reached over 10,000 complaints. According to Dr. Janet Hull, one of the top researchers on the dangers of aspartame, the FDA began to categorize the complaints regarding aspartame into generic categories not related to aspartame, "such as death", for example. "If the death by seizure was reported as a reaction to aspartame, the death was recorded as seizure only and not as an 'aspartame' seizure." says Dr. Hull. Before 1992, when complaints were accepted as directly related to aspartame consumption, between 78% and 85% of all FDA complaints were about aspartame.

What Contains Aspartame?

There are approximately 6000 products on the market that contain aspartame. Some of them include:

* diet sodas

* hot chocolate mix

* lemonade mix

* children's vitamins

* puddings

* yogurt

* chewing gum

* flavored water

* frozen desserts

* gelatins

* "sugar free" items

* "no sugar added" items

* "___% less sugar" items

The FDA seems unwilling, despite ever mounting evidence that this toxic substance is affecting people daily, to reconsider their position regarding its approval. Our own state law makers seem unable or unwilling to protect us further by shelving bills, legislation, and petitions that could potentially save lives by outlawing aspartame. Even some doctors seem more concerned that a ban on aspartame might actually affect the economy adversely, although it seems to be perfectly capable of crashing without the help of a ban on aspartame, than sound science and saving human lives. We can only protect ourselves. For the sake of your and your family's health, check the labels on every item that you put into your grocery cart from vitamins to water to chewing gum.

The last thing you want, is to end up as another ignored complaint on the FDA's website, another ignored name on a petition to law makers, a misdiagnosed complaint in your doctor's office, or another name added to the "unfortunate reaction" list of deaths to this toxic substance.

If you have a complaint regarding aspartame, please visit the FDA’s website at:

((http://www.fda.gov/opacom/backgrounders...)

References:

((http://www.government-propaganda.com/as...)

((http://www.opednews.com/articles/opedne...)

(http://www.khon2.com/news/local/14447192.html)

(http://www.dorway.com/cdctext.txt)

((http://www.janethull.com/askdrhull/arti...)

About the author

Jennifer McKinley is a wife, mother of five, homeschooler, and business owner. She has spent years researching issues dealing with holistic and natural medicine and how different chemicals in our homes, foods, medications, and environments effect our health and quality of life. Her goal is to promote public awareness and knowledge regarding these issues.

Weston A. Price Foundation to FDA: Soy is No Health Food

The Weston A. Price Foundation, a nonprofit nutrition education foundation, has submitted a petition to the Food and Drug Administration (FDA) asking them to change a rule that currently allows soy protein to carry a heart disease health claim.

Manufacturers of soy products have been able to label them “heart healthy” since 1999. The Weston A. Price Foundation’s 65-page petition was filed in response to the FDA’s request for public comment on the issue.

"We have filed this petition because there was never a sound basis for a soy health claim and the heavy marketing of soy as a 'miracle food' has put American men, women and children at risk," said Kaayla Daniel, lead author of the petition that was officially filed by Sally Fallon, president of the foundation.

The petition documents longstanding concern in the scientific community -- including the FDA’s own Laboratory for Toxicological Research -- regarding soy’s possible role in:

• Carcinogenesis
• Thyroid disease
• Reproductive health problems including infertility
• Other illnesses

Further, the Foundation claims that the evidence on soy protein and heart disease is "contradictory and inconsistent, and no standard of scientific agreement has been met."

Sources:

• Weston A. Price Foundation Soy Petition (PDF)

• Physorg.com February 19, 2008

Toxic toothpaste leads to new charges

LOS ANGELES, California (AP) -- Criminal charges have been filed against a company that prosecutors say imported and distributed nearly 90,000 tubes of Chinese toothpaste containing a poisonous substance and a wholesaler supplier of the tubes, City Attorney Rocky Delgadillo announced.

Selective Imports Corp. sold the toothpaste containing diethylene glycol to distributors nationwide between December 2005 and May 2007, prosecutors said Thursday. Vernon Sales Inc. is accused of buying some of the tubes and reselling them to Los Angeles stores.

Diethylene glycol is a chemical used in antifreeze and as a solvent. Chinese manufacturers have used the chemical, known as DEG, as a cheaper alternative to glycerin, which thickens toothpaste. Exposure to DEG, however, can cause kidney and liver damage over time.

Vernon Sales President Kamyab Toofer, Vice President Pejman Mossay and the company itself each were charged with 14 criminal counts of receiving, selling and delivering an adulterated drug.

Selective Imports, its president, Frahad Nazarian and Vice President Yones Ghermezi each were charged with two criminal counts each of receiving, selling and delivering products containing DEG.

The companies are liable for distributing the tainted product even if they had no direct knowledge of the risk because they were negligent in not ensuring the toothpaste was safe, Supervising Deputy City Attorney Jerry Baik said.

The misdemeanor charges were filed Monday, he said. Each count carries a maximum penalty of one year in jail and a $1,000 (650 euros) fine.

Don't Miss

• Special: Made in China

Ghermezi said he had not seen the charges but was shocked by the filing. All the adulterated toothpaste was voluntarily pulled from shelves and from his Vernon, California, company's inventory eight months ago and destroyed by the U.S. Food and Drug Administration last month, he said.

"Everything we had was destroyed by the FDA," Ghermezi said. "I thought the file had been closed."

Ghermezi said he supplied the toothpaste to Vernon Sales, also based in Vernon. He said his company never knowingly sold adulterated toothpaste and believed the product had approval of the FDA regulatory agency.

"We didn't know of the ingredients of the toothpaste," he said. "We don't (have) any intention of hurting people."

A fax to Vernon Sales seeking comment was not immediately returned.

China's reputation as an exporter has taken a beating in the past year following recalls of products including the toothpaste, toys tainted with lead, and pet food fortified with the toxic chemical melamine.

Last month, a federal grand jury indicted Las Vegas-based ChemNutra Inc. and two Chinese businesses in the tainted pet food incidents that killed potentially thousands of animals.

ChemNutra and its owners were charged with multiple misdemeanor counts of introducing adulterated and misbranded food into interstate commerce, along with one felony count of conspiracy to commit wire fraud.

The Los Angeles charges stem from an investigation after the FDA confiscated some 70,000 tubes of adulterated toothpaste delivered to the Port of Long Beach in May, Baik said.

The FDA confiscated that shipment when it came from the same Chinese manufacturer as DEG-tainted cough syrup blamed for the deaths of at least 94 people in Panama since July 2006, he said.

The company executives charged Monday were accused of involvement in the sale of toothpaste delivered in a previous shipment, Baik said.

At least 480 tubes were resold by Vernon Sales to stores within Los Angeles, which gave the city attorney's office jurisdiction to investigate, he said.

Baik did not know how many of those tubes had been recovered and how many had been sold.

The shipments that came before the seizure in May included 78,336 tubes of spearmint-flavored "Cooldent" toothpaste sold by Selective Imports to distributors around the country, according to the city attorney's office.

Nearly 10,000 additional tubes of fluoride "Cooldent" were also distributed around the country in early May, prosecutors said.

Baik said he know of no illnesses associated with the toothpaste in Los Angeles.

FDA spokeswoman Rita Chappelle said she was not aware of anyone outside the city who had fallen ill after using the toothpaste

FDA - the real Terminators

Reflux Disease Treatment Nexium Now Approved for Children Ages 1 to 11

FDA has approved Nexium (esomeprazole magnesium) for short-term use in children ages 1 to 11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved the drug in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children ages 1 to 11, compared to 20 mg or 40 mg recommended for pediatric patients ages 12 to 17.

Simply amazing. I recall the movies Matrix and Terminator, when I think of the mindless things that people and organizations and governments do, I assume it is payoffs with money, and it is justified by ignorance of the human body and nutrition. Perhaps it is a plot to create apathy, complacency or ultimately catatonic ....

Very sad that children have to suffer from this "disorder." When the real disorder are the nutritionally ignorant parents, who would allow Doctors to give to "OK" for their children to be given Nexium being big pharmaceutical paid once again the FDA to get this drug approved.

If the human body was truly a machine leave a car, where you could simply replace parts and make the body run on an alternative fuel source then that is ok I suppose.... but WE ARE NOT MACHINES, we are NOT designed to eat garbage and cover up the symptoms with synthetic toxic chemicals because of the greed of the pharmaceutical companies and the brainwashing they have done to our Doctors.

FDA & Medical Doctors & Drugs

Your doctors think they make decisions based on
medical evidence.

But they don't!

In fact, half of medical evidence is hidden from
your doctors. And the half that's hidden is the
half that shows drugs don't work.

The bad news is that drug companies are not
policed by the Food and Drug Administration
(FDA) the way they should be. A drug should be
proven both effective and safe BEFORE it is
prescribed to millions of people.

Sadly, that often isn't the case.

Let me share with you two recent examples that
highlight the dangerous collusion between drug
companies and our government agency. They show
why the FDA should really stand for "Federal
Drug Aid."

First, we now know that the cholesterol-lowering
drug Zetia actually causes harm and leads to
faster progression of heart disease DESPITE
lowering cholesterol 58 percent when combined
with Zocor.

This challenges the belief that high cholesterol
causes heart attacks and shakes the $40 billion
dollar cholesterol drug industry at its
foundation.

Second, it's come to light that nearly all the
negative studies on antidepressants - that's
more than half of all studies on these drugs -
were never published, giving a false sense of
effectiveness of antidepressants to treat
depression.

Don't get me wrong.

I'm not telling you to blame your doctor.

Instead, blame deceptive scientific practices
and industry-protective government polices.

==> Let's talk a closer look at these findings
and their implications.


I once had a patient who worked in the drug
approval division of the FDA. She taught me a
very important lesson.

When a drug company designs and performs a
study, it has to be registered with the FDA and
ALL the results must be submitted to the FDA.

But it doesn't work that way.

Instead, the pharmaceutical companies ONLY
submit the data they want to get published to
medical journals.

That means that any negative studies are hidden
from the scientific community and from the
public.

And when drug studies are sponsored by drug
companies - as most are - they find positive
outcomes at 4 times the rate of independently
funded studies. This is also true for nutrition
studies funded by the food industry that show
the benefits of dairy or high-fructose corn
syrup.

The FDA does not release this information.

That was, it didn't until 2004 when all the
major scientific journals banded together and
refused to publish any data from any drug study
that did not list the results of all trials,
either positive or negative, in a central
database. (1)

Well, that sounds good - but listing obscure,
unpublished studies buried deep in a hard-to-
navigate public database run by the National
Institutes of Health is hardly visible public
disclosure.

Sure, the research studies are at least listed,
but try to find out the results.

After a few hours searching around on the
website clinicaltrials.gov, I gave up.

Last year, Congress passed legislation expanding
how much detail must be listed, but at the end
of the day, who even looks at that?

Most doctors don't even have time to read the
medical journals they receive. They get tiny
bits of information from drug reps, who come to
their office with free lunch and a sound bite
about their drug.

They get slightly more information from
researchers who are funded by pharmaceutical
companies and present their findings at
conferences sponsored by pharmaceutical
companies, using presentations prepared for them
by pharmaceutical companies.

Not exactly independent, evidence-based
medicine!

==> Now let's get back to the news about Zetia.

Zetia is a new drug that lowers cholesterol by a
different mechanism than statin drugs like
Lipitor and Zocor.

Why does this matter?

Well, doctors have been brainwashed to think
that cholesterol is the cause of heart attacks
even though half of all people who have heart
attacks have NORMAL cholesterol.

And it seemed like the statins, which lowered
cholesterol, actually reduced heart attacks.

Seems logical. If you lower cholesterol, you
reduce heart attacks, right?

No!

I believe that the reason statins lower risk is
NOT because they lower cholesterol, but because
they reduce inflammation.

In fact, studies by Dr. Paul Ridker of Harvard
show that the risk of heart attacks was only
reduced if inflammation was lowered along with
LDL cholesterol - but not if LDL cholesterol was
lowered alone. (2)

So then along comes a drug that can be combined
with statins to lower cholesterol even more.
Great idea?

Not really.

You see, the FDA approved Zetia without any
proof that it lowered heart attacks or reduced
the progression of heart disease. The drug was
approved solely on the basis that it lowered
cholesterol.

Yet Zetia was given to 5 million people - and
made the drug companies $5 billion a year.
That's almost $14 million a day!

And once Zetia was approved, its makers had no
incentive to prove that it actually did what it
was thought to do - lower heart attacks.

They dragged their feet doing the studies and
then released the negative data (which they did
only under pressure from news agencies and
Congress) after a long delay.

Wouldn't you drag your feet too if you were
making $14 million a day?

But the FDA had the negative data on Zetia - and
it didn't speak up.

The data that was withheld proved that Zetia did
not reduce heart attacks but actually INCREASED
fatty plaques in the arteries despite lowering
cholesterol.

Let that sink in for a moment.

That's right: Lowering cholesterol led to more
heart disease!

That turns our whole medical model upside down.
It shows us that high cholesterol is NOT a
disease and may or may not be related to heart
attacks.

Another recent study put another nail in the
coffin of the Cholesterol Myth.

A major new cholesterol drug, torcetrapib, was
pulled from the pipeline in December 2006
because despite lowering LDL cholesterol and
raising HDL cholesterol in 15,000 people, it
caused MORE heart attacks and strokes. (3)

This was to be the new cholesterol wonder drug.
Oops.

==> All this points to a big research mess that
is flawed in three ways.



First, what gets studied depends on who is
funding it.

Since drug companies fund most of the research
in the world, other therapies that work better -
such as diet and lifestyle or nutritional
therapies - never get enough funding.

Second, drug companies are aided by the FDA,
which suppresses, hides, and doesn't publish
negative studies on drugs, only positive ones.
This leads doctors to think they have all the
evidence when they don't.

Third, doctors, patients, and the media believe
they have the whole truth, often until it is too
late, like with Zetia or Premarin or Vioxx.

The evidence was there, but no one looked or
publicized it.

This makes it very difficult for consumers to
get the best treatments for their health and the
whole truth about drugs.

Here's my advice on how to make sense of things.

1. Follow the money. Look carefully at who
funded the study. Be suspicious if it was funded
by drug companies.

2. Call or email your congressperson or Senator
to demand better legislation providing an easy-
to-navigate database of all drug trials, with
consumer-friendly summaries of both published
AND unpublished data submitted to the FDA so you
can look up the drug you are prescribed and have
a balanced opinion.

3. Don't assume that drugs are the answer to
your health problems. Heart disease is NOT a
Lipitor deficiency but the result of your
lifestyle interacting with your genes.

4. Learn to ask the question "why?" - and search
for the answers. Dealing with lifestyle and
environmental factors almost always works better for
chronic illnesses. Drugs are there as a backup
only if needed.

So take a closer look at the information you've
been given about drugs. You might be surprised
by what you find.

Now I'd like to hear from you...

Were you aware of the studies I've mentioned
today?

Which of the steps here do you plan to follow?

What has you experience been with medications
compared to lifestyle measures?




REFERENCES:

(1) Laine C, Horton R, DeAngelis CD, Drazen JM,
Frizelle FA, Godlee F, Haug C, Hebert PC, Kotzin
S, Marusic A, Sahni P, Schroeder TV, Sox HC, Van
der Weyden MB, Verheugt FW.Clinical trial
registration: looking back and moving ahead.
JAMA. 2007 Jul 4;298(1):93-4.

(2) Ridker PM, Cannon CP, Morrow D, Rifai N,
Rose LM, McCabe CH, Pfeffer MA, Braunwald E;
Pravastatin or Atorvastatin Evaluation and
Infection Therapy-Thrombolysis in Myocardial
Infarction 22 (PROVE IT-TIMI 22) Investigators.
C-reactive protein levels and outcomes after
statin therapy. N Engl J Med. 2005 Jan
6;352(1):20-8.

(3) Kastelein JJ, van Leuven SI, Burgess L,
Evans GW, Kuivenhoven JA, Barter PJ, Revkin JH,
Grobbee DE, Riley WA, Shear CL, Duggan WT, Bots
ML; RADIANCE 1 Investigators.Effect of
torcetrapib on carotid atherosclerosis in
familial hypercholesterolemia. N Engl J Med.
2007 Apr 19;356(16):1620-30.

FDA Approved the Wrong Drug Plant

According to the FDA, the Chinese facility that supplies the active ingredient of the widely used blood thinner heparin was never inspected because the agency confused it with another plant that had the same name.

A team of FDA inspectors is now headed to China to inspect the correct plant, as part of an effort to determine what caused a sudden spike in serious reactions to heparin.

More than 350 adverse reactions to the drug have been reported to the FDA since the end of 2007, including a dangerous drop in blood pressure, breathing difficulties, and vomiting. Four patients who took the drug died.

Federal law does not require inspections of foreign drugmakers, although the agency will in most instances inspect before a new foreign drug or active drug ingredient is allowed in FDA-approved prescription medications. Such an inspection does not necessarily include an on-site visit if the company has passed previous inspections for other drugs.

Big Pharma took over the church cartoon

Supreme Court destroys consumers rights to sue corporations!

In a disturbing decision, the Supreme Court has just surrendered the rights of consumers to the FDA and medical device corporations. From this point forward, corporations have been granted blanket immunity from consumer lawsuits over FDA-approved medical devices, even if those devices are defective! And now the Bush administration is pushing for blanket immunity for Big Pharma too, which would deny consumers the right to sue over the harm caused by dangerous drugs. -- Source Natural News / News Target.

The U.S. Supreme Court has ruled that medical device manufacturers cannot be sued for injuries caused by their products if those products were pre-approved for use by the FDA.

The court ruled that Charles Riegel, who was injured in 1996 when a balloon catheter made by Medtronic Inc. burst while being inserted into one of his coronary arteries during an angioplasty, could not sue the company for damages. In doing so, the Supreme Court upheld a ruling by a U.S. appeals court and an earlier ruling by a trial court in New York.

Hiding behind a legal technicality

Medtronic, which no longer makes the balloon catheter in question, said that the fault was with the doctor, who used the device contrary to the operating instructions. The company also said that the doctor made an error in using that type of product for a patient in Riegel's condition. But rather than ruling in Medtronic's favor merely for the one specific instance, the court dismissed the case entirely, saying that federal law prohibits suing device manufacturers in state courts if the device was approved as safe by the FDA. The decision is expected to have ramifications for a large number of pending lawsuits against manufacturers of devices such as breast implants, defibrillators, artificial heart pumps and valves, drug-coated stents, spinal cord stimulators, and prosthetic hips and knees.

Because there is no federal law that allows consumers to sue medical device manufacturers for damages, state courts have become a common venue for such suits.

The legal reasoning behind the court's decision centered on the wording of the 1976 Medical Device Amendments law. The law, which set in place an FDA pre-approval process for medical devices, explicitly prohibited states from putting in place "any requirement" that is "different from, or in addition to" FDA requirements. In an 8-1 majority, the court ruled that allowing citizens to sue device companies in state courts amounts to "a requirement" that undermines the FDA approval process.

Writing for the majority, Justice Antonin Scalia wrote that the FDA may approve devices "that present great risks if they nonetheless offer great benefits in light of available alternatives." In other words, there is no requirement that devices actually achieve any reasonable level of safety for all patients. To receive FDA approval and be immunized from lawsuits, medical devices merely have to keep alive slightly more people than they kill.

It would be inappropriate to empower juries second-guess these FDA decisions without full access to data about the benefits of technologies, Scalia said. This is the Supreme Court's way of saying that medical device safety is define solely by the FDA, and if the FDA says something is safe, the fact that such devices actually kill people does not in any way disprove the device's safety.

A jury "sees only the cost of a more dangerous design, and is not concerned with its benefits; the patient who reaped those benefits are not represented in court," he wrote. This is a clever way of saying that products that kill some consumers -- but not all -- are safe enough to be granted blanket immunity because there are some survivors. It's a ridiculous position, of course, and it's never applied to natural remedies.

Note that if an herb kills even ten people in the entire country, the FDA immediately leaps to the conclusion that the herb is "unsafe at any dose." (Google the history of the FDA's ephedra ban for details.) But medical devices and pharmaceuticals are held to an entirely different standard: They must only avoid killing more people than they kill! The fact that some people survived the treatment is apparently sufficient to justify all those who died! This is precisely what Justice Scalia is saying in this decision.

FDA -- Prescription Drug User Fee Act (PDUFA)

Congress has not only created that structure but they have horribly worsened it with the Prescription Drug User Fee Act (PDUFA) by which drug companies actually pay money to the FDA so they will review and approve their drug. This creates an absolutely massive conflict of interest and fox-guarding-the-henhouse phenomena.

PDUFA was enacted 13 years ago and passed by Congress as a way of providing the FDA with more funds. This way, it could hire more physicians and other scientists to review drug applications so drugs could be approved more quickly.

You see, every day a drug is held up from being marketed to you they lose about $1 million to $2 million. Yes, you read it correctly, $1-2 MILLION for every DAY the drug is held up from being approved.

So the obvious incentive is to approve drugs as quickly as possible and not stand in the way of profit-making.

Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towed the approval of drugs and 20 percent is for everything else. Drug safety is a measly 5 percent. This speaks loads about their priorities. It is NOT about protecting you -- it is about approving drugs as quickly as possible so the drug companies can reap their profits.

Statin Drugs -How Statin Drugs Wreck Your Muscles

Statins, a popular set of drugs used to lower cholesterol, can result in muscle weakness and pain, and even debilitating and life-threatening muscle damage. A new study offers the first evidence that a gene known as atrogin-1 plays a key role in statin-related muscle toxicity.

Statins such as Lipitor, Zocor, Pavacol and Mevacor lower cholesterol by inhibiting HMG-CoA reductase, a key enzyme in cholesterol synthesis. But they may also activate the gene atrogin-1 gene, which plays a key role in muscle atrophy.

Three separate tests showed that even at low concentrations, statin drugs led to atrogin-1 induced muscle damage. As the concentration was increased, the damage increased as well.

Sources:

• Newswise November 27, 2007

• The Journal of Clinical Investigation December 2007; 117(12):3940-51

FDA approved Alli

Boxes of Alli, the first FDA-sanctioned diet drug to be sold without a prescription, are selling in huge numbers, despite the fact that the pill comes with the potential for extremely unpleasant and embarrassing side effects.

The manufacturer has predicted that 5 million to 6 million Americans a year will buy the drug.

The GlaxoSmithKline drug, which was introduced to the market several years ago in a prescription-only form called Xenical, blocks the absorption of about 25 percent of consumed fat. That would eliminate about 225 calories from a 3,000 calorie per day diet.

However, the drug can also result in loose stools and gas with an oily discharge. The drug's official website states that, "It's probably a smart idea to wear dark pants, and bring a change of clothes with you to work," if you take the drug.

Los Angeles Times June 15, 2007


Yet again, another pill promising entry into the magical land of forever-skinny ... The release of the new diet "wonder drug" Alli has prompted a stampede of women throwing all common sense to the wind, chasing the ever-elusive gratification of instantaneous weight loss. Alli, if taken together with a low-fat, reduced-calorie diet, supposedly lets you lose about 50 percent more weight than dieting alone, according to GlaxoSmithKline.

Want Diapers With That?

However, the message of "healthy balanced diet and exercise" is falling on deaf ears. Most of the people buying the drug seem to expect it to work miracles with no effort on their part. And they are also ignoring warnings of side effects such as potentially humiliating anal leakage in the hopes that the drug will finally provide the effortless cure they seek.

Millions of Americans are going to pay $59.99 per box for a myth. At least 31 studies by researchers at UCLA have confirmed that dieting by itself, even aided by a pill, doesn't lead to sustained weight loss or any significant health benefits. On any given diet, people initially lose 5 percent to 10 percent of their weight, but then they gain it back, often with some additional pounds as well.

Dieting is actually a consistent predictor of future weight gain; those who participate in formal weight-loss programs usually gain significantly more weight over a two-year period than those who have never participated in such a program.

Doctors Outraged--FDA Ignored Cancer Risk When Approving Alli

In February 2007, the FDA approved Alli--an over-the-counter version of the diet drug Orlistat (Xenical).

The Public Citizen's Health Research Group has voiced concerns about Orlistat’s safety and efficacy for the past 10 years, as it's been shown to cause pre-cancerous lesions of the colon.

In April of 2006, a group of doctors with Public Citizen petitioned the FDA to ban Orlistat and deny OTC status to the lower dosage version Alli, offering testimony that Orlistat raises the risk of both colon cancer and gallstones.

Public Citizen cited unpublished studies on Orlistat, showing:

* Orlistat increases the precursor markers to colon cancer by 60 percent in rats.
* When eating a high fat diet and taking Orlistat, the cancer risk increased 2.4 fold.
* Fat soluble vitamin E depletion, due to Orlistat's fat blocking action, raises the risk of colon cancer even further.
* Recorded adverse reactions to Orlistat include: 39 cases of increased abnormal blood thinning; several cases of bleeding episodes; 10 hospitalizations, four with life threatening reactions, and one death.
* Dangerous thinning of the blood can occur in people taking drugs like Warfarin (an anti-coagulant), or who suffer from vitamin K deficiency.

In addition, the FDA itself found 37 cases of gallstones in patients of all ages, between 1999 and 2006, prior to releasing Alli for over-the-counter sale.

The safety analysis from the Public Citizen's Health Research Group is that Alli "has marginal weight loss benefits, common and bothersome G-I tract reactions, significant decrease in absorption of fat soluble vitamins, and problematic use in the millions of people using Warfarin or Cyclosporine."

The FDA denied Public Citizen's petition on the same day they approved Alli as an OTC.

Turning Medicine Into Snake Oil: How Pharmaceutical Marketers Put Patients At Risk

Executive Summary

False and misleading prescription drug advertising is common and dangerous. Prescription drug marketers are inundating doctors, and to a lesser extent, the public, with marketing that misrepresents risks, promotes unproven uses, and makes unsubstantiated claims. The false and misleading messages are communicated through conventional advertising, sales representatives, doctors speaking on behalf of drug marketers, and through clinical trial suppression, manipulation and misrepresentation. Sadly, the Food and Drug Administration (FDA) is ineffective at addressing the problems. This report takes a comprehensive look at all of these facets of the prescription drug marketing problem and suggests effective solutions.

FINDINGS IN BRIEF
We looked at enforcement letters FDA sent to drug marketers from 2001-2005. Our research reveals:

Deceptive drug marketing is pervasive, dangerous, and primarily aimed at doctors.

• From 2001-2005, 85 companies received 170 notices from the FDA explaining that the marketing for 150 different drugs was false and/or misleading.

• 62% of the false or misleading messages targeted doctors, and those messages were expressed by 38 different types of advertising. By contrast, the public was exposed to 17 different types of false or misleading ads.

• The false messages were serious: 35% misrepresented risk; 22% promoted unproven uses; and 38% made unsupported or misleading claims. For deceptive messages targeting doctors, 37% misrepresented risk; 24% promoted unproven uses; and 36% made unsupported or misleading claims.

Recidivism is rampant.

• 28 companies—approximately 1/3 of the total— received more than one letter declaring their ads false or misleading in the five years we examined. In fact, these companies accounted for two-thirds of all the letters received.

• 26 companies received more than one letter relating to advertising for the same drug that was deemed false or misleading in the same way.

Deceptive marketing includes sales representatives.

• Sales representatives, as a group, form long and deep relationships with doctors, beginning in medical school. Research suggests those early relationships increase doctors’ receptiveness to sales representatives once they are in practice.

• Perhaps reflecting those relationships, other research has shown that sales representatives have a profound influence on prescribing decisions.

• Sales representative statements accounted for 30 of the 869 deceptive messages in the FDA letters, an amount that is enormous given the very small percentage chance that the FDA will detect such statements. Other research suggests that as much as 11% of sales representative statements are false and favorable to the product they pitch.

Deceptive marketing includes clinical trials.

• In the letters identifying advertising as false or misleading because it contained unsupported claims, FDA highlighted at least 82 times that the advertising cited clinical trials for propositions they did not support. In some instances, the cited trials even contradicted the claims.

• Drug marketers turn clinical trials into marketing tools by suppressing some unfavorable data; by using PR firms to write favorable reports (the PR firm does not appear as an author of the report, instead a doctor is retained to be the named author); by misrepresenting unfavorable data that is published; and, most subtly, by designing studies to get only the results they want.

Our numbers dramatically understate the problem.
The FDA letters we examined do not address anywhere near the full universe of prescription drug marketing.

• The FDA routinely reviews only “classic” advertising and does not comprehensively monitor sales representatives, doctors acting as pitchmen, or clinical trial data manipulation. Moreover, the FDA’s review of classic advertising is not complete; not all ads are submitted to it, and of those that are, the FDA only reviews some.

• The FDA letters rarely identify how many times, or where, an ad was used. A deceptive print ad may have run in several newspapers and magazines. Each of those print runs would be another dissemination of the deceptive messages in the ads.

• The FDA reviews advertising after it has been disseminated and only requires corrective measures a quarter of the time.

• The best measure is how many people internalized the deceptive measure, an impossible figure to determine. The 869 disseminations of deceptive messages that we were able to count from 2001- 2005 included TV ads, print ads, and other mass media. How many people are deceived by a single deceptive TV ad watched by a million viewers? Similarly, a single sales representative may convey deceptive messages to hundreds or thousands of doctors in a year.

RECOMMENDATIONS
States Can Solve the Problem

• To address the scientific misconduct that is the suppression, manipulation and misrepresentation of clinical trial data, states should establish a comprehensive, searchable database of clinical trials. Drug marketers would register every clinical trial done in humans for every drug they sell in the state. To be successful, the clinical trial registry must include all the clinically significant aspects of the trial design and trial results. Such a registry would be placed in the state’s department of health, and could be financed with registration fees from the drug marketers.

• To address the problem of deceptive classic advertising, deceptive sales representative statements and deceptive doctor-to-doctor marketing, states can create a new type of citizen lawsuit. This would allow citizens to sue for injunctive relief—stopping the false advertising and conducting corrective advertising—reasonable attorney’s fees, and, at the judge’s discretion depending on the circumstances of the case, civil penalties payable only to the state. Suits could only be won if the deceptive advertising created a public health risk; deceptive advertising that misleadingly, but not dangerously, hypes a drug’s properties would not qualify. Doctors, their patients, attorneys general, and in certain instances, the public, would have standing to sue, depending on the type of marketing.

Examples of sufficiently dangerous advertising might include promoting a drug for illnesses for which the company knows it’s not effective, or denying or consistently minimizing serious risks. The advantage of this approach is it enables the recipients of deceptive advertising—the people who can most easily detect it—a way to address the problem but it avoids creating financial incentives that would distort enforcement.

Increasing Enforcement at FDA
To make the FDA a potent regulator able to prevent and correct deceptive advertising, it needs more power and financial resources to:

• Review all advertising submitted to it before it is disseminated, in a commercially relevant timeframe, so that deceptive classic advertising is not used;

• Review sales representative training materials and make unannounced inspections of training sessions;

• Review the presentation materials for talks given by doctors on behalf of drug marketers and make unannounced visits to the talks;

• Require and oversee corrective advertising in every situation where deceptive marketing occurs;

• Require drug marketers to get the FDA’s approval before citing any study as support for any claim; and finally,

• Levy significant fines against drug marketers, fines that escalate to truly punitive levels, to serve as a deterrent and eliminate today’s rampant recidivism.

The Medical Profession’s Role: Improve Prescriber Education and Information Resources
Th e medical profession and the independent organizations and academic institutions that service it can help.

• Doctors need better access to independent, accurate, digested information about drugs. The information produced by the clinical trial registry should be packaged by an independent group or agency into a form easily useable by prescribers who want information about treatment options. The information provided should include not only the clinically important information about each drug, but also how the drug compares to other treatments in terms of safety, efficacy, and cost. The Drug Effectiveness Review Project (DERP) generates this information, but it is aimed more at policy makers than prescribers. Similarly, Consumers Union takes DERP’s data and packages it for patients, as part of its BestBuyDrugs project. To the extent that the information is already accessible (for example, The Medical Letter), the profession must find a way to ensure that doctors use it. Only by breaking their reliance on sales representatives and other sources of promotional information can doctors ensure they are getting unbiased information.

• Medical schools and teaching hospitals should heavily invest in training students and residents to be skeptical of pharmaceutical sales representatives and to rely on independent sources of information.

REPORT ROADMAP
After introducing the problem and laying out the regulatory context, the report presents the results of our analysis of the most comprehensive database on false and misleading advertising available: FDA’s enforcement letters to pharmaceutical companies engaging in deceptive marketing practices. We look at five years of letters to see what kinds of false messages pharmaceutical companies are directing toward whom and how. We also explain why those numbers are grotesque understatements of the problem. One reason they are understatements is that they mostly address conventional advertising, such as ads in professional journals or on TV; they rarely address sales representative statements or the presentations made by doctors consulting for the drug marketer. The latter activities are currently beyond the FDA’s resources to monitor.

Then we look at the ways the FDA currently fails to address even the classic advertising slice of the false marketing problem, the one it monitors as closely as it can. As part of our evidence of the FDA’s failure, we describe the high rates of “general recidivism,” that is, drug marketers that have received multiple letters from the FDA about their false or misleading marketing, and “specific recidivism,” that is, drug marketers who have received multiple letters about their advertisements for a single drug, advertisements that are all false or misleading in the same way.

We complete our analysis of the deceptive marketing problem by focusing on the marketing outside of the FDA’s routine review. Specifically, we focus on prescription drug sales representatives and clinical trials. Sales representatives are powerful marketing forces because they have many opportunities to interact with physicians, and the evidence shows that they give false and misleading information far too often. As disturbing as our findings in this area are, they may be mitigated to some extent, given that doctors may expect sales representatives to present misleading information. After all, their job is to sell drugs, not educate physicians. Clinical trials, however, are the cornerstone of prescription drug science, and few physicians let alone patients would anticipate the extent to which drug marketers shape and control them.

We conclude with concrete solutions that states can take now and offer recommendations for addressing FDA’s problems. Fortunately, steps the states can take are powerful enough to rein in the drug marketers to the point where the public can again be confident that they and their doctors are consistently receiving accurate information. Best of all, the state steps are inexpensive.

THE APPENDIX—CASE STUDIES
To fill in the big picture of deceptive marketing we sketch, we present six case studies of deceptive marketing of prescription drugs in the appendix, located in the center spread. Four—Vioxx, OxyContin, Paxil, and Neurontin—are offered primarily to illustrate different features of the problem and to convey how deceptive messages can permeate drug marketing. Two other case studies, Accutane and Tindamax, are included to highlight the FDA’s inability to police drug marketers.