This is a guest article by Mannie Barling and Ashley F. Brooks.

The infinite power of corporate America to influence outcomes has now poured over into corrupting the field of food and drug marketing and testing. According to a 2011 study released by JAMA and another conducted in 1996, many medical research articles are written by ghostwriters working for the food and drug manufacturers with profit motives.

The study reported a ghostwriting rate for drug products as 7.9% in JAMA, 7.6% in The Lancet, 7.6% in PLoS Medicine, 15.3% in the New England Journal of Medicine, 14.3% in The Annals of Internal Medicine and 2% in Nature Medicine. Many consider these numbers the tip of the iceberg. For example, Dr. John Ioannidis, an expert on medical bias, has estimated that as much as 90% of the medical research doctors rely on to treat patients is flawed.

In the case of food, there is no clear information on how and who prepares industry articles trumpeting the benefits of their food and safety. But you can be sure those numbers are even higher than drugs because of the lack of adequate regulations to control the content of food articles.

Most scientific reports, abstracts, white papers and peer-reviewed publications are manipulated like play dough to achieve the desired goal of the company paying for the scientific test results and the articles and abstracts written in their support. For example, Mead Johnson will pay between $8 million and $12 million in infant formula and cash to settle false advertising claims set out in articles and other marketing releases.

A medical abstract is a summary paragraph included with each medical study published. It’s supposed to give the reader a quick overview of the study results. The problem is that these abstracts may or may not reflect the actual results of the study. In many cases, especially when expensive drugs are involved, the study abstract may give a summary that is the opposite of the actual results. Most doctors and other medical professionals don’t have time to read entire studies and therefore rely on the abstracts.

Like puppeteers or marionette manipulators, Big Food and Big Pharma control every potential comment made about their products. And there is no room for any criticism from independent scientists or reviewers. Dr. John Ioannidis also wrote, “There is increasing concern that most current published research findings are false… Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.”

While this is not new, the art of manipulating medical and food information first started with the Rockefeller family more than 100 years ago, and has become an art form used by America’s largest companies. Now, with the complicity of the U.S. government and universities, corporate America is as much in control of the content and flow of information as the Nazi’s were during their reign of terror in Germany.

The current trend first runs rampant in schools like Harvard and Iowa State where the universities and professors have routinely accepted payments from Big Food and Big Pharma to promote their products. For example, three doctors at Harvard accepted more than $4.2 million in unreported income to validate the off-label use of an untested drug for children. Monsanto contributed more than $4 million to Iowa State, Texas A&M and Florida to endow chairs in Monsanto related biotech research goals.

In some instances, the industry has used this control to create such shams as “Smart Choices” labels which deceived parents as to the contents of children’s foods and breakfast cereals. In other cases, the industry has carefully controlled the testing of genetically modified seeds by withholding the seeds from independent scientists while funding their own tests to confirm whatever theories Monsanto needs to foster the sales of its seeds. It is not a pretty picture.

At Harvard, more than 1,800 professors received payments that many in Congress construed as bribes, including bribes to teach medical students to sell Statin drugs. At the same time, Big Food has skillfully made payments to the above universities to fund studies, research and graduate-level research by young scientists.

The two industries perpetuate a shroud of industrial bribery and deception which they euphemistically call “editorial assistance”, while others prefer to call it a more friendly term, “publication planning”.

Publication planning is the process by which pharmaceutical, biotech and medical device companies produce and release articles in magazines and journals to promote sales. Ghostwriters are hired to create these materials in a marketing industry specializing in covert projects and public deception, much like the CIA.

As one example, DesignWrite boasts about their ghostwriting prowess on their website, stating that, for more than 12 years, it “… planned, created, and/or managed hundreds of advisory boards, a thousand abstracts and posters, 500 clinical papers, over 10,000 speakers’ bureau programs, over 200 satellite symposia, 60 international programs, dozens of websites, and a broad array of ancillary printed and electronic materials.” To our knowledge, DreamWrite is a marketing company not a research lab.

In addition to “full-length review articles”, DesignWrite offers marketing plans that include mini-reviews, case reports, editorials, letters and commentaries. It also helps companies decide what data to present, recruits “authors,” chooses journals, creates abstracts and posters for medical meetings.

Big Pharma sees these marketing tools as an efficient “means of placing important information about the therapeutic profile of an agent into the hands of influential physicians ….” DesignWrite then assists in submitting the paper to respected journals. The deception is that the papers are knowingly not truthful.

Do you wonder if you have ever bought a product that DesignWrite was responsible for marketing by its ghostwriting and untruthful clinical papers?

In the case of one author, DreamWrite’s deceitful conduct in preparing studies and articles for the prescription drug Vioxx resulted in a heart attack. After his doctor read all of the abstracts, pamphlets and clinical tests before prescribing the drug to his patients, the author’s doctor felt Vioxx was safe to prescribe for him. After about three months on Vioxx, this author suffered a heart attack.

After Vioxx was pulled from the market by the FDA and following an extensive investigation, the Justice Department prosecuted Scott S. Reuben, MD for falsifying clinical test results so that Merck could obtain FDA approval of Vioxx. This approval was then piggy-backed by Pfizer, who did no testing, to obtain approval of Celebrex by the FDA.

Vioxx, Bextra and Celebrex became blockbuster drugs (sales in excess of a billion dollars) as a result of this deception. Why was Merck permitted by the FDA to control the testing of their own drug? And, why was Pfizer permitted to piggy-back the approval of Celebrex on the false tests of Vioxx? Because, the FDA supports the industry instead of protecting the general public.

As usual, it took litigation over the drugs, Premarin and Prempro, that harmed tens of thousands of women (300,000 women in Florida alone) to obtain confidential documents that exposed the truth about industry marketing practices. Why does it always take expensive litigation or a whistleblower to get any truth out of an American corporation? The two industries’ mantras are delay, use deep pockets to exhaust their opponents and continue to lie until getting caught. Doesn’t this sound much like our government’s policy on war and other important issues too?

Dr. Adriane Fugh-Berman is the director of PharmedOut, a Department of Physiology and Biophysics, Georgetown University Medical Center who serves as director of the university-based project founded with public money from the Attorney General’s Consumer and Prescriber Grant program. She found that DirectWrite had been paid to ghostwrite the various articles, pamphlets, scientific abstracts sent to doctors and journal as well as writing the supplements, bound publications, white papers, slide kits, and symposium materials for such products as Premarin and Vioxx.

In her report, Dr. Fugh-Berman examined unsealed documents in litigation against Wyeth Laboratories to investigate the use of medical writing companies to produce ghostwritten manuscripts and place them into medical journals. She chronicled how more than 14,000 women became victims of breast cancer as a result of Premarin family of products in her 1,500 page study”HRT”. It is a damning report.

These documents were not made public until PLoS Medicine and The New York Times intervened in the Wyeth litigation. The following are some of the salient points contained in her study:

*    Between 1997 and 2003, DesignWrite’s output for Wyeth on the Premarin family of products included “over 50 peer-reviewed publications, more than 50 scientific abstracts and posters, journal supplements, internal white papers, slide kits, and symposia…”. None of them were true.

*    The practice of paying doctors and scientists to sign articles written by ghostwriters is so widespread that it is considered normal by many – an atmosphere of systemic deception.

*    Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms caused by these drugs.

*    These marketing articles are not peer-reviewed. Nonetheless they are spread around the medical profession as gospel. Because there is no peer review, doctors are not afraid of being caught signing articles in exchange for money.

*    The false truths advanced by these deceitful marketing tools have resulted in decades of carefully orchestrated deceptions adopted by an unknowing public.

*    DesignWrite was assigned to write 20 secondary review articles in 1997 for $20,000 each, a price that later rose to $25,000 each. By 2011, they must cost much more.

*    DreamWrite charged $4,000 for writing abstracts, $10,000 for editing manuscripts and $2,000 for editing abstracts to include deceptive materials provided by Wyeth.

*    “Wyeth paid $413,140.60 for a supplement that was mailed to 128,000 physicians and Gynecology Editions of Women’s Health in Primary Care. Wyeth bought 1,500 additional copies for distribution to its sales force and distributed the supplement to media and ‘select thought leaders’, including well-positioned doctors [who could influence their peers].”

*    When one author submitted a manuscript directly to a journal, DesignWrite was paid to influence the author into changing the article to a deceptive draft prepared by DreamWrite instead.

*    Authors were considered interchangeable. If one author did not want to sign off on an article, another would be paid to do it.

*    Ghostwriters also respond to editor and reviewer’s questions and comments to avoid direct contact with the paid-for author, who may have told the truth about the product’s failings when confronted.

*    Ghostwriters defended their articles by attacking reviewers in contrary posts and letters.

*    Ghostwritten articles were used to attack competing drugs and the efficacy of competing generics.

On June 15, 2011, outgoing Secretary of Defense, Robert Gates, said to Congress, “… all governments lie to each other.” What he should have said is that “all governments and big business lie to each other – and to their citizens and consumers.” Companies like DreamWrite are just capitalizing on the two industries’ predisposition to lie to promote sales.

On June 20, 2011, St. Louis Rams linebacker David Vobora was awarded $5.4 million by a federal judge in his lawsuit against a supplement maker after he was suspended by the NFL for four games in 2009 for using a contaminated product intentionally misrepresented by its manufacturer. I wonder who wrote the fraudulent sales material.

Another example is that it is illegal for pharmaceutical companies to promote a marketed drug for off-label uses, which are defined as uses other than those uses approved by the FDA. Nonetheless, the drug industry actively employs companies like DreamWrite to promote off-label uses ignoring the law.

Review articles in medical journals are crucial vehicles for encouraging off-label uses and promoting unproven benefits. Many prescription drugs would not be successful or become blockbuster drugs (a drug that has sold more than $1 billion) if it were not for off-label sales. The manufacturers know the FDA will do nothing to stop their lies unless or until a significant number of Americans die. So how many Americans must die before the FDA or USDA act to protect citizens?

According to Dr. Fugh-Berman, “DesignWrite helped to produce numerous ghostwritten reviews and commentaries, including articles designed to promote the off-label use of Prempro for preventing Alzheimer’s disease, Parkinson’s disease, age-related macular degeneration, and wrinkles.” Prempro has not been proved to affect any of these illnesses, but has been proven to cause breast cancer. It is amazing the lengths to which”editorial assistance” is used to sell food and drugs – even when the manufacturer and ghostwriter know the real truth.

Sadly, articles published in medical journals, newsletters and magazines are not considered as promotional marketing tools by the FDA. According to critics, “Peer-reviewed publications offer pharma companies shelter from often-stormy regulatory waters. FDA views published articles as protected commercial speech so [it] doesn’t regulate their content.”

This is clearly an FDA loophole created to benefit food and drug companies. This policy is certainly not intended to protect the general public.

The purpose of creating ghostwritten reviews and commentaries is to: (1) Mitigate perceived risks associated with the promoted drug; (2) Push unproven, but profitable, off-label uses; (3) Attack their client’s competitors; (4) Defend benefits despite the lack of studies and testing to support their client’s claims; and (5) Increase sales even when the product is ineffective or potentially harmful to patients.

DreamWrite was paid to manufacture lies and untruthful marketing materials on behalf of their clients at a substantial profit. While Wyeth’s attitude can be summed up in the words of one of its employees, Gerald Burr, who when faced with a problem with an uncooperative author, wrote, “You can’t just put another name on the article, but you can plagiarize the way we did when we wrote papers in college.” For many of their employees, the lying started early.

According to Dr. Fugh-Berman:

Ghostwriting has also been documented in the promotion of Paxil (paroxetine), “Fen-phen” (fenfluramine and phentermine), Neurontin (gabapentin), Vioxx (rofecoxib), and Zoloft (sertraline).

Big Food and Big Agra employ a bevy of ghostwriters to put out untruthful information about genetically engineered seeds, genetically modified foods, the conditions of factory farms, the effects of MSG and other addictive chemical ingredients to promote the sales of their food products. They will never admit how many.

The evidence is overwhelming that Americans can no longer believe the information provided by Big Food, Big Agra and Big Pharma companies. Americans need to do more than just rely upon media ads, the information on food labels, the advice of the many bought-and-paid-for nutritionists, doctors and other paid-for spokespersons and do their own research to protect their families from the dire consequences of these foods and additives. As a result of false information contained in ghostwritten articles, both authors nearly died.

Be careful.  Be watchful. And be vigilant to protect you and your family.
Mannie Barling and Ashley F. Brooks, R.N., are the authors of award winning books – Arthritis, Inflammation, Gout, Crohn’s, IBD and IBS – How to Eliminate Pain and Extend your Life (Books and Authors 2010 Best Books in the Health, Diet & Reference Categories) and Mannie’s Diet and Enzyme Formula – A Change of Lifestyle Diet Designed for Everyone (Blogger News Net 2010 Best Health And Nutrition Book Award winner) available at HowToEliminatePain.com, Amazon, Barnes&Noble, and other booksellers around the world.

It’s Not Your Fault – Weight Gain, Obesity and Food Addiction is now available at HowtoEliminatePain.com, Amazon and booksellers everywhere. The authors latest book, The Food Revolution Papers – A Primer on What’s in Your Food, is due in bookstores on October 1, 2011.

Mannie Barling and Ashley F. Brooks are the co-hosts of Surviving the 21st Century with Simon Barrett on Blogger News Network on Saturdays at 10:00 A.M. PST/1:00 PM EST and The Food Revolution Papers, on Thursday mornings at 9:00 AM PST, 12:00 noon PST, found at http://www.bloggernews.net or Blog Talk Radio.

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