Monday, March 4, 2013

Questioning Truth: Behind the Scenes of Publishing Medical Science


For years the most profitable business in the U.S. has been the pharmaceutical corporations, which routinely top the annual fortune 500 list. Doctor prescribed drugs support an industry which out-earns the GNP of many nations.

Many thanks to Dr. Beatrice Golomb, associate professor of medicine at the University of California, San Diego, for this inspiration.

For every dollar pharmaceutical companies spend on "basic research," $19 goes toward promotion and marketing.

And apparently it's been working. Drug company revenues climbed more than $200 billion in the years between 1995 and 2010, according to the website MinnPost. Meanwhile, in recent years, more than one in five Americans age 50 and up have had to cut down on their dosages or switch to cheaper generic drugs because the cost of medication is so high.

(Alexander Eicher, "Pharmaceutical Companies Spent 19 Times More On
Self-Promotion Than Basic Research: Report," The Huffington Post, August 9 2012)

But with high profits came significant indications of criminality. The global pharmaceutical industry has racked up fines of more than $11 billion in the past three years for criminal wrongdoing, including withholding safety data and promoting drugs for use beyond their licensed conditions.

In all, 26 companies, including eight of the 10 top players in the global industry, have been found to be acting dishonestly. The scale of the wrongdoing, revealed for the first time, has undermined public and professional trust in the industry and is holding back clinical progress, according to two papers published in the New England Journal of Medicine.
(Jeremy Laurance, "Fines Are Not Enough to Reform Drug Industry,
Warn Lawyers," The Independent, September 20 2012)

FYI = Did You Know What Goes on Behind the Scenes of Editing and Publishing in Medical Science?

Bias #1: Unwanted Results are Not Published

In order for scientific studies to happen, someone has to pay for them. Since the manufacturer is most invested in “proving” the quality of the drug, the top funder for any drug trial is the pharmaceutical company that makes it.
The second-highest funder of drug studies is the National Institute of Health (NIH), which is not the group of neutral government experts you may have assumed them to be.  
In fact, NIH accepts a great deal of money from Big Pharma and is deeply enmeshed with the industry. But drug companies publish only a fraction of the studies they fund -- the ones that promote their drugs.

"Over half of all supporting trials for FDA-approved drugs remained unpublished ≥ 5 y after approval. Pivotal trials and trials with statistically significant results and larger sample sizes are more likely to be published. Selective reporting of trial results exists for commonly marketed drugs."

(Kirby Lee, Peter Bacchetti, Ida Sim. "Publication of Clinical Trials Supporting Successful New Drug Applications: A Literature Analysis."
PLOS Clinical Trials. 2013) 

Bias #2: Bad Results are Submitted as Good

When a scientific study has findings that cast doubt on the efficacy of a drug, oftentimes the negative findings are morphed into positive ones. Even if studies can't make the results look good, there are ways to "twist" conclusions. This is known as selectively omitting negative trial results. It can be devastating to the health of a nation.

For example, in 2008, FDA officials analyzed a registry of 74 antidepressant trials, which included trials that were published and those that were not. The FDA’s findings were then written up in an article in the New England Journal of Medicine.
This is what they found:
  • 38 of the trials reported positive results, and 37 of the 38 were published.
  • 36 trials had negative or questionable findings. Of the 36, 22 were not published at all, and 11 were published in a way that conveyed the results as though they were positive.
So, if you just went to the published literature, it would look like 94 percent of the studies were positive, when in reality only about 50 percent were positive ... equivalent to a coin toss.

(Erick H. Turner, M.D. and others. "Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy," New England Journal of Medicine, 2008)

Bias #3: A Favorable Study is Submitted Multiple Times

When a study yields positive results, it is often submitted multiple times in a way that the reader doesn’t realize it’s the same study, obscured by different author lists and different details. Analyzers have had to look very carefully to determine which studies are actually duplicates because they are so cleverly disguised.
In one analysis of the published reports about ondansetron (an anti-nausea drug), the same study was published 5 times. This duplication of data led to a 23 percent overestimation of ondansetron’s effectiveness when a meta-analysis was performed.

( Service of the U.S. National Institutes of Health, April 15 2008)

Bias #4: Follow-Up Reviews Done by Biased Experts

The editorials that follow from a study, submitted by so-called unbiased experts and then published in reputable journals, are often done by non-neutral parties who have a financial tie to the drug maker
The case of calcium channel blockers (a type of heart medication) are an example. The connection between authors declaring their support for calcium channel blockers and those not in support of them was highly statistically tied to their affiliation with the drug manufacturer -- in fact, the odds that their opinion was NOT due to their affiliation was more than 1,000:1.
"Dr. Bruce Psaty had found that a class of relatively new and expensive drugs—calcium channel blockers—was associated with a higher risk of myocardial infarction than older less expensive drugs.
"Psaty received requests from several drug companies that he found intimidating—for documents, tables, manuscripts, and new analyses. Pfizer's attorneys made use of Washington State's Freedom of Information Act to ". . . request all records, reports, data, analyses, correspondence, and any other documentation related to the design, conduct, results and conclusions of this study.

"Psaty noted that, at the time of this work, roughly 20% of patients with hypertension were taking calcium channel blockers, so the findings were potentially of major public health significance. The drugs were heavily marketed to physicians and enjoyed a growing market share. They were 15 times more expensive than older alternatives, which were known not only to reduce blood pressure but also to reduce the devastating complications of hypertension such as stroke, myocardial infarction, and heart failure."

"Bruce Psaty and the Risks of Calcium Channel Blockers." Quality and Safety in Health Care, 11:294-296, 2002)

Bias #5: Ghostwriting

Many of the articles that appear in medical journals purportedly written by well-known academics are actually written by unacknowledged ghostwriters on Big Pharma payroll
Consider the example of Parke-Davis and their drug Neurontin.  
Parke-Davis contracted with a “medical education communication company,” or MECC, which is a company paid almost exclusively by pharmaceutical companies to write articles, reviews, and letters to editors of medical journals to cast their products in a favorable light.

"Despite clear knowledge of the lack of efficacy of gabapentin, the Defendants funded numerous meetings and written material where the use of Neurontin for bipolar disorder was deceptively recommended. These programs and journal supplements consistently advocated the use of Neurontin for treating bipolar disorder and suggested that there was scientific support for this proposition...
"As a direct result of the concealment or misrepresentation of critical Level 1 Evidence, many psychiatrists and mental health professionals became falsely convinced that Neurontin was a safe and effective treatment for bipolar disorder, and many patients were treated accordingly. However, this conclusion was based on the illusion of scientific support...."
(Jeffrey S. Barkin, "Report on the Use of Neurotin For Bipolar and Other Mood Disorder," July 25 2008)
In this case, MECC was paid $13,000 to $18,000 per article. In turn, MECC paid $1,000 each to friendly physicians and pharmacists to sign off as authors of the articles, making the material appear independent.

This was also done by Pfizer as a strategy for marketing Zoloft. A document was written that included 81 different articles promoting Zoloft’s usefulness for everything from panic disorder to pedophilia.

The only problem was, for some articles, the name of the author was listed as "to be determined," even though the article was listed as already completed. Pfizer wrote the article, and then shopped around for scientists willing to claim authorship, to give it a veneer of credibility. 

Bias #6: Journal Bias

Medical journals are generally considered by medical practitioners to be a source of reliable information. But medical journals are also businesses.

Three editors, who agreed to discuss finances only if they remained anonymous, said a few journals that previously measured annual profits in the tens of thousands of dollars now make millions annually.

The truth is that Big Pharma has become quite adept at manipulating and brainwashing practitioners of conventional medicine. They influence the very heart and center of the most respected medical journals, creating dogma and beliefs that support the drug paradigm because it is blessed by the pinnacle of scientific integrity: the prestigious peer-reviewed medical journal.

Peer-reviewed medical journals contain advertisements that are almost exclusively for drugs, amidst articles that are biased toward promoting those drugs.

In 2003, drug companies spent $448 million dollars on advertising in medical journals. It has been calculated that the return on investment on medical journal ads is between $2.22 and $6.86 for every dollar spent, with larger and older brands at the higher end.
Long-term returns may be even higher when you consider that one ad viewed by a physician could result in hundreds or even thousands of drug purchases, based on the prescriptions he or she writes.

The term “peer-review” has come to imply scientific credibility. But the fact is that many of the peer-reviewers are on the drug company’s payroll, and those who are not are unlikely to detect flawed research or outright fraud. 
Medical journals are the number one source of medical information for physicians. In fact, nearly 80 percent of physicians use medical journals for their education, which exceeds information from any other source.

In 2004, Dr. Richard Horton, editor of the Lancet, wrote, “Journals have devolved into information-laundering operations for the pharmaceutical industry."  
Jerry Kassirer, another former editor of the New England Journal of Medicine, argues that the industry has deflected the moral compasses of many physicians.

(Richard Smith. "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies. PLoS Med 2(5): e138. 2005)           

Bias #7: Drug Companies Masquerading as Educators

The education of medical students and residents also comes through the filter of the drug industry, which seeks to groom them before they even finish medical school. 
Big Pharma now spends $18.5 billion per year promoting their drugs to physicians. That amounts to $30,000 per year for every physician in the U. S.

Almost half of the members are representatives of Big Pharma or are consultants for businesses that work directly with it to prepare these educational programs. Only a few represent academic CME institutions.

"In several instances, the ex-employees say, the physicians were told to push “off-label” uses of the drugs — those not approved by the U.S. regulators — a marketing tactic banned by federal law."
(Charles Ornstein and Tracy Weber, "Lawsuits Say Pharma Illegally Paid Doctors to Push Their Drugs," ProPublica, October 18 2010)
In the past three years alone, pharmaceutical companies have anteed up nearly $7 billion for settlements in cases such as one filed by Angela Maher, a former drug sales rep for Ortho-McNeil Pharmaceutical."

Any discussion of physician “seduction” would be incomplete without the mentioning of the 100,000 drug reps, who are groomed and trained to wine and dine and otherwise shower physicians in sweetness until they are handing out prescriptions like candy. 
A core attribute to big Pharma’s overwhelming ‘success’ lays in the liaison between the corporations and the ‘symptoms management’ health care industry: The pharmaceutical representative. The men and women we see meeting with physicians, walking into offices with gifts of lunch for the staff, meeting with the doctor while you wait for our appointment.
Reps are even taught tactics for manipulating doctors for industry benefit, as a standard part of their training.
Gwen Olsen was a top level pharmaceutical rep for some of the biggest in the industry: Johnson & Johnson, Syntex Labs, Bristol-Myers Squibb, Abbott Laboratories and Forest Laboratories.

Through some chilling wake up calls in her tenure, and the tragic drug-related death of her niece, Gwen has dedicated her life to making people aware of the dangers of prescription drugs and how the drug industry manipulates doctors into prescribing, and over prescribing, their drugs.
 Gwen Olsen
Listen to Gwen: 
"Well, initially when you start pharmaceutical sales training you are taken into the home office for a sort of ‘indoctrination’ that’s 2-6 weeks of intensive training. That’s where the industry turns representatives into psychological profilers and people pleasers. The reps learn how to be people analyzers, so they know how to best influence people. We were taught in training sessions called ‘knee to knees’ and ‘toe to toes’ where you have a line of reps that play the doctor and opposing lines that play the rep position.
"You have to learn verbatim the company’s position and their marketing lines- you can’t even vary from that. You practice and practice until it flows naturally and doesn’t sound rehearsed. 
"I started recognizing really that I was being trained to divert doctor’s attention away from his/her concerns. So, I was learning to misinform and disinform- to counter the doctor’s valid concerns. I wasn’t trained to say 'this drug is bad for that patient' or 'watch out for this drug’s interaction with that one.' Any information perceived as a negative was always being candy coated.

"In fact many times we would be called into a meeting when a new sales piece was being introduced. Managers would ask us questions on what aspects of the piece we received the most objections on. What were the parts that raised the most concern? After we gave the marketing department that feedback, the next period they would come up with a different layout that had manipulated and minimized the objectionable data. So, it was a constant set of circumstances where I began to see that I wasn’t allowed to give good information and I wasn’t given good information to share.

"The industry knows that many of their drugs aren’t safe and that they don’t heal people. In fact, some drugs are designed to make symptoms worse later on."

(Adam Helfer, "Drugging America: The drug Industry Exposed," The Washington Post, March 27 2011)

The Gwen Olsen Video:

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The Full Article By Dr. Beatrice Golomb, Associate Professor of Medicine at University of California, San Diego:


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