From the December 2003 Idaho Observer:

Pharma Ghostwriting Revealed: how drug firms 'hoodwink' medical journals

Pharmaceutical giants hire ghostwriters to produce articles - then put doctors' names on them

Antony Barnett, public affairs editor

Sunday December 7, 2003

The London Observer

Hundreds of articles in medical journals claiming to be written by academics or doctors have been penned by ghostwriters in the pay of drug companies, an Observer inquiry reveals.

The journals, bibles of the profession, have huge influence on which drugs doctors prescribe and the treatment hospitals provide. But The Observer has uncovered evidence that many articles written by so-called independent academics may have been penned by writers working for agencies which receive huge sums from drug companies to plug their products.

Estimates suggest that almost half of all articles published in journals are written by ghostwriters. While doctors who have put their names to the papers can be paid handsomely for 'lending' their reputations, the ghostwriters remain hidden. They, and the involvement of the pharmaceutical firms, are rarely revealed.

These papers endorsing certain drugs are paraded in front of GPs as independent research to persuade them to prescribe the drugs.

In February the New England Journal of Medicine was forced to retract an article published last year by doctors from Imperial College in London and the National Heart Institute on treating a type of heart problem. It emerged that several of the listed authors had little or nothing to do with the research. The deception was revealed only when German cardiologist Dr Hubert Seggewiss, one of the eight listed authors, called the editor of the journal to say he had never seen any version of the paper.

An article published last February in the Journal of Alimentary Pharmacology, which specialises in stomach disorders, involved a medical writer working for drug giant AstraZeneca - a fact that was not revealed by the author.

The article, by a German doctor, acknowledged the 'contribution' of Dr Madeline Frame, but did not admit that she was a senior medical writer for AstraZeneca. The article essentially supported the use of a drug called Omeprazole - which is manufactured by AstraZeneca - for gastric ulcers, despite suggestions that it gave rise to more adverse reactions than similar drugs.

Few within the industry are brave enough to break cover. However, Susanna Rees, an editorial assistant with a medical writing agency until 2002, was so concerned about what she witnessed that she posted a letter on the British Medical Journal website.

“Medical writing agencies go to great lengths to disguise the fact that the papers they ghostwrite and submit to journals and conferences are ghostwritten on behalf of pharmaceutical companies and not by the named authors,” she wrote. “There is a relatively high success rate for ghostwritten submissions - not outstanding, but consistent.”

Rees said part of her job had been to ensure that any article that was submitted electronically would give no clues as to the origin of the research.

“One standard procedure I have used states that before a paper is submitted to a journal electronically or on disc, the editorial assistant must open the file properties of the Word document manuscript and remove the names of the medical writing agency or agency ghostwriter or pharmaceutical company and replace these with the name and institution of the person who has been invited by the pharmaceutical drug company (or the agency acting on its behalf) to be named as lead author, but who may have had no actual input into the paper,” she wrote.

When contacted, Rees declined to give any details. “I signed a confidentiality agreement and am unable to comment,” she said.

A medical writer who has worked for a number of agencies did not want to be identified for fear he would not get any work again.

“It is true that sometimes a drug company will pay a medical writer to write a review article supporting a particular drug,” he said. “This will mean using all published information to write an article explaining the benefits of a particular treatment.

“A recognised doctor will then be found to put his or her name to it and it will be submitted to a journal without anybody knowing that a ghostwriter or a drug company is behind it. I agree this is probably unethical, but all the firms are at it.”

One field where ghostwriting is becoming an increasing problem is psychiatry.

Dr David Healy, of the University of Wales, was doing research on the possible dangers of anti-depressants, when a drug manufacturer's representative emailed him with an offer of help.

The email, seen by The Observer, said: “In order to reduce your workload to a minimum, we have had our ghostwriter produce a first draft based on your published work. I attach it here.”

The article was a 12-page review paper ready to be presented at a forthcoming conference. Healy's name appeared as the sole author, even though he had never seen a single word of it before. But he was unhappy with the glowing review of the drug in question, so he suggested some changes.

The company replied, saying he had missed some “commercially important” points. In the end, the ghostwritten paper appeared at the conference and in a psychiatric journal in its original form - under another doctor's name.

Healy says such deception is becoming more frequent. “I believe 50 per cent of articles on drugs in the major medical journals are not written in a way that the average person would expect them to be... the evidence I have seen would suggest there are grounds to think a significant proportion of the articles in journals such as the New England Journal of Medicine, the British Medical Journal and the Lancet may be written with help from medical writing agencies,” he said. 'They are no more than infomercials paid for by drug firms.'

In the United States a legal case brought against drug firm Pfizer turned up internal company documents showing that it employed a New York medical writing agency. One document analyses articles about the anti-depressant Zoloft. Some of the articles lacked only one thing: A doctor's name. In the margin, the agency had put the initials TBD, which Healy assumes means “to be determined.”

Dr Richard Smith, editor of the British Journal of Medicine, admitted ghostwriting was a “very big problem.”

“We are being hoodwinked by the drug companies. The articles come in with doctors' names on them and we often find some of them have little or no idea about what they have written,” he said.

“When we find out, we reject the paper, but it is very difficult. In a sense, we have brought it on ourselves by insisting that any involvement by a drug company should be made explicit. They have just found ways to get round this and go undercover.”

***

CDC stands by suspicious study, finds no link between mercury and retarded neurological development

Meanwhile, one in five American children will soon be neurologically impaired

compiled by The Idaho Observer

Insight Magazine posted an article December 8 by investigative reporter Kelly Patricia O'Meara titled “CDC Study Raises Level of Suspicion” that questions the credibility of the CDC and its conclusion that vaccines containing thimerosal, a mercury-based adjuvant, are in no way associated with the epidemic rise in autism and other neurological problems.

The CDC study entitled, “Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases” was published in the November, 2003 edition of Pediatrics. The study concluded that, “...no consistent significant associations were found between TCV [thimerosal-containing vaccines] and neurodevelopment outcomes.”

It is well-known that eating fish containing traces of mercury can impair cognitive development and cause neurological problems. For some reason, though, mercury is suddenly “safe if it is used in 'silver' amalgams or injected directly into the bodies of infants and children through a hypodermic needle.

According to O'Meara, the study's lead author, Dr. Thomas Verstraeten, is an employee of GlaxoSmithKline, one of the world's largest vaccine manufacturers and one of several drug companies currently being sued over its thimerosal-containing vaccines.

Phase I of the study began in 1999 while Dr. Verstraeten was working for the CDC and began by using data from Group Health of Seattle and North California Kaiser. The data here actually showed significant association between TCVs and a wide range of neurodevelopmental disorders such as speech delays and attention deficit/hyperactivity disorders.

These associations were not published with the final draft but revealed later. Notes not published with the study showed the “ 'relative risk' for autism was 2.48 times higher for children who received 62.5 micrograms or more of mercury from TCVs by three months of age,” O'Meara reported.

Phase II, began in June 2000 when Dr. Verstraeten chose to mine the database of the Harvard Pilgrim HMO of Massachusetts for information pertinent to his study. By the time he began his research, the HMO was in bankruptcy, its medical records were incomplete and the data were stored using a completely different coding system than the system used by the first two HMOs. Furthermore, the Harvard Pilgrim HMO data did not address the autism issue. It should not be surprising then that the Harvard Pilgrim data did not indicate a relationship between neurodevelopmental problems and TCVs.

The theory that the GlaxoSmithKline employee intentionally sabotaged the study is supported by the comments of Rep. Dave Weldon (R-FL) in a letter to acting CDC Director Julie Gerberding: “I have serious reservations about the four-year evolution and conclusions of this study. A review of these documents leaves me very concerned that, rather than seeking to understand whether or not some children were exposed to harmful levels of mercury in childhood vaccines in the 1990s, there may have been a selective use of the data to make the associations in the earliest study disappear.”

Weldon's letter continues explaining that “the first version of the study.found a significant association between exposure to [TVCs] and autism and neurological developmental delays. A June 2000 version of the study applied various data manipulations to reduce the autism association to 1.69, and the authors went outside the VSD [Vaccine Safety Datalink] database to secure data from a Massachusetts HMO in order to counter the association found between TCVs and speech delays.”

The CDC stands behind the report, still claiming there is no relationship between TCVs and neurodevelopmental problems even though independent researchers have also found such a link. The U.S. Department of Education reports that the average increase in autism by state is 400 percent. The Harvard Pilgrim part of the study happened to be in Massachusetts, the state showing the lowest increase in autism at 10 percent.

Dr. Mark Geier, whose work is supported by the findings of Drs. Singh, Yazbak, Wakefield and others, after reviewing the CDC study stated, “Believe us, there is no scientific issue here. This is fraud. The CDC and the FDA know what is happening. They just can't admit it because it is one of the worst things ever to happen to this United States. If a terrorist had done this, we wouldn't attack them, we'd nuke them. We're talking about one in eight children in the U.S. who are in special education and that number is going to change to one in five. What percentage of our population can we destroy before we realize how serious this is?”

With thanks to Kelly Patricia O'Meara and Insight magazine for publishing this timely and revealing story.

***

Epic LA Times article exposes cesspool of collusion between public health officials, NIH, drug companies

Five years in the making, the LA Times has just published the 10,000 word article “Stealth Merger: Drug Companies and Medical Research” that casts doubt on every public health policy ever endorsed by the National Institutes for Health (NIH) and, by extension, the Centers for Disease Control and the Department of Health and Human Services and every drug approved by the Food and Drug Administration. The collusion between public health officials and the pharmaceutical industry have become so institutionalized that there appears to be no functional division between the two.

In 1998 the LA Times began investigating drug company payments to the NIH and agency research collaboration with industry. The NIH reports that it has supplied the LA Times with 13,784 pages of documents under 36 Freedom of Information Act requests. These documents include memos, financial disclosure reports and emails. The LA Times also conducted dozens of interviews, reviewed lawsuits in state and federal courts and filings with the Securities and Exchange Commission.

Dr. Paul Connett noted that LA Times reporters David Willman, Janet Lundblad, Robert Patrick and Christopher Chandler deserve a Pulitzer prize for this article.