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Welcome to the May 2012 homepage edition of i2P-Information to Pharmacists. Rollo Manning has been having some time out having staples removed from the site of his open heart surgery.He is now at home recuperating in Darwin, having arrived home last Friday, beating a cold and hasty retreat from Canberra.We all wish him a speedy recovery and hopefully, he will be fit enough to contribute by next month.
This month, Pharmedia discusses the toll that is taken when someone complains about you to an authority without good cause. Well, the good news is that you can now take action to protect yourself if such a complaint is made, and that may even include action for defamation. Read about a recent case involving two doctors, with Mark Coleman drawing on personal experience to illustrate.

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A TGA-Managed Database of Fully Evaluated Complementary Medicines Evidence – a Real Possibility

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Neil Johnston articles by this author...

Neil Johnston is a pharmacist who trained as a management consultant. He was the first consultant to service the pharmacy profession and commenced practice as a full time consultant in 1972, specialising in community pharmacy management, pharmacy systems, preventive medicine and the marketing of professional services. He has owned, or part-owned a total of six pharmacies during his career, and for a decade spent time both as a clinical pharmacist and Chief Pharmacist in the public hospital system. He has been editor of i2P since 2000.

Last month when the controversy surrounding the PGA/Blackmore’s proposed alliance brought out a large number of critics, the PGA found itself in an extremely vulnerable position.
Some criticism was well-deserved - other criticism arose from misperception surrounding the proposed alliance, while other criticism evolved surrounding the “evidence” relied on by the alliance to underpin their clinical promotion - was blown out of all proportion, or negatively criticised.
More positively, academic Dr Ken Harvey called for the TGA to manage an evidence database for complementary medicines that have had a full evaluation.

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The uproar caused the PGA and Blackmore’s to abandon their proposed alliance, and many PGA “enemies” were able to use the incident to their advantage.
There was some concern by i2P in that while the basic idea had some merit, project implementation as originally described, had the potential for abuse.
However, some of the elements of the original proposal, if used correctly, may have had the potential to assist pharmacy patients.

The clinical evidence relied upon seemed impossible to evaluate because:

* No single Australian database existed for evidence (drugs or complementary medicines) that had been properly rated by a reliable external ratings agency.

* No database existed that could authenticate even supposed “gold standard” evidence because at least 20-30 percent of that data is contaminated through big-pharma manipulation involving the use of “ghost writers”, to magnify benefits of their drug or point to a conclusion not supported by the original investigational data.
A description of the process of “ghost writing” is explained further along this article – a process that I believe must constitute academic fraud!

i2P was recently contacted by well-known academic Dr Ken Harvey to support an initiative he was preparing in respect of an evidence database managed by the TGA, with the consumer organisation CHOICE facilitating the process.
i2P agreed to support this initiative and added a signature to the CHOICE letter addressed to the TGA.
The following is the original full text of this letter and the TGA response.

CHOICE letter

Dr Rohan Hammett
National Manager
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

Dear Dr. Hammett,

Re: A TGA list of registered (and properly evaluated) Complementary Medicines (CMs)

The recent Australian National Audit Office (ANAO) report titled, “Therapeutic Goods Regulation: Complementary Medicines” said (43):

“It would enhance transparency and help inform both consumers and healthcare professionals if the TGA were to place the summary of evidence it collects from sponsors, as received, on its website—with a clear indication of whether it had been assessed or evaluated by the TGA.”

There are a small number of registered CMs on the Australian Register of Therapeutic Goods (ARTG). If these products have been registered recently, it means that they have been properly assessed for quality, safety and efficacy (unlike Listed CMs which predominate on the ARTG). Examples of registered CMs include Blackmores Flexagil Pain Relief cream (a clinically proven comfrey root extract) for the topical treatment of sprains and osteoarthritis and Flordis Iberogast (a clinically proven nine herb mixture) for Irritable Bowel Syndrome.

Unfortunately, some registered CMs were “grandfathered” into the ARTG, without proper evaluation, e.g. ARTG no: 68083 ARTHRO-AID Glucosamine hydrochloride (see appended).

At this point in time, there is no way the ARTG can be searched to obtain a list of registered CMs let alone those that have been properly evaluated as distinct from “grandfathered”.

We believe that it is important for the medical profession and community to be aware of the more evidence-based CMs that are currently registered by the TGA and for us to provide constructive feedback where needed. Can you please provide us with this data?

May we also suggest that the TGA compiles a list of properly evaluated registered CMs and places this on the TGA website. In the longer term, we suggest that the ARTG database should contain an additional searchable field to distinguish CMs from other medicines.

We believe that these initiatives by the TGA would make a nice response to paragraph 43 of the ANAO report.

Sincerely,

Nick Stace (CEO, CHOICE)

Carol Bennett (CEO, CHF)

Dr Vicki Kotsirilos, GP and expert on CM

Neil Johnston, Editor, Information to Pharmacists (I2P)

Dr Ken Harvey, School of Public Health, La Trobe University
cc Lynn Weekes CEO, NPS

TGA response (the same response was sent individually to each signatory)

Mr Neil Johnston
Editor
Information for Pharmacists (12P)
PO Box 297
Alstonville NSW 2477

Dear Mr Johnston,

TGA list of registered Complementary Medicines

Thank you for your letter of 18 October 2011 concerning access by consumers to information about registered complementary medicines. I note the several co-signatories to your letter who share an interest in this matter.

At the current time, there are some 200 registered complementary medicines on the Australian Register of Therapeutic Goods (ARTG). As you point out in your correspondence, a small number of these have been fully evaluated while the majority were 'grandfathered' onto the ARTG at the time that the register was created, along with many other registered medicines, non-complementary OTC medicines, prescription medicines and listed products.

I acknowledge that the searchability of the ARTG for consumers and health professionals in relation to complementary medicines has some limitations. However, the TGA is committed to improving the transparency of our operations and increased regulatory effectiveness.  I will seek advice as to the options for ARTG enhancements to allow identification of registered complementary medicines and fully evaluated registered complementary medicines, respectively.

In the interests of enhanced information for consumers and health professionals, 1 agree with your suggestion that the TGA should publish on our website a list of those registered complementary medicines that have been fully evaluated. I have asked the relevant officers in the TGA to develop this list for publication.

Should you have any queries regarding these matters please don't hesitate to contact Mr Ian Stehlik in the Office of Complementary Medicines on 02 62328439 in the first instance.

Yours sincerely

Dr Rohan Hammet,
National Manager
November 2011

Finally, the start of a reliable database that establishes a standard, and for the first time may prove to be an extremely useful tool for any clinician wishing to engage in clinical practice, without having unwarranted criticism descend on them.
For an explanation of how this type of criticism arises, view comments about the “flip-flop” rhythm of science contained in the article: Truth in Medicine – Weighing the Evidence.

Ideally, any evidence posted to the TGA site will include a full investigation, including a determination whether any input was “ghost-written”, and if so, disallow that “evidence” until it is properly authenticated.

One of the more flagrant offences committed by pharmaceutical companies and the medical profession is the practice of "ghost writing" medical articles.

A new cross-sectional survey published in an article in the British Medical Journal found that more than 20 percent of articles published in six leading medical journals during 2008 were likely written by honorary and/or ghost writers. 

This is lower than it was in 1996, but still far too prevalent; contaminating data to deliberately confuse and mislead- but always directing a reader disproportionately towards the claimed benefits represented by a sponsored drug.

For medical journals, ghost writing usually refers to writers sponsored by a drug or medical device company, who make major but uncredited research or writing contributions. 

The articles are instead published under the names of other academic authors.

Such "inappropriate authorship" leads to a lack of transparency and accountability, which has become an important concern for the academic community.

According to the article in the British Medical Journal:

"Inappropriate authorship (honorary and ghost authorship is an important issue for the academic and research community and is a threat to the integrity of scientific publication.

Our findings suggest that 21 percent of articles published in 2008 in the general medical journals with the highest impact factors had an inappropriate honorary author, and that nearly eight percent of articles published in these journals may have had an unnamed important contributor.

The highest prevalence of both types of inappropriate authorship occurred in original research articles, compared with editorials and review articles.

...Both honorary and ghost authorship are unacceptable in scientific publications, and each form of inappropriate authorship has important consequences.

...Honorary authorship has implications for scientific integrity... Likewise ghost authorship has important implications and consequences. If un-identified authors are involved in the work and manuscript preparation, readers not only will be unaware of the contributions, perspectives, and affiliations of these individuals, but also may not appreciate the influence or potential underlying agenda these individuals may have on the reporting of material in the article (such as may occur with ghost authors employed by industry)."

Two Canadian law professors have called for legal sanctions.
“It's fraudulent for academics to give their names to medical articles ghost written by pharmaceutical industry writers”, says Trudo Lemmens, one of the law professors, based at the University of Toronto.
“Studies suggest that industry-driven drug trials and industry-sponsored publications are more likely to downplay a drug's harms and exaggerate a drug's virtues”.
“The integrity of medical research is also harmed by ghost written articles.”
“False representation of authorship is in our view, fraud.”

Ghost writing is part of a marketing process that can distort the evidence of a drug.
Industry author's identities are concealed to enable insertion of marketing messages in the primary text, and academic experts are recruited as "guest" authors to lend credibility despite not fulfilling criteria for authorship, such as participating in the design of the study, gathering data, analysing the results and writing up of the findings.

Class actions involving drugs such as Vioxx, hormone replacement therapy and antidepressants suggest guest authors often fail to meet criteria for authorship, according to the policy paper in a recent issue of Public Library of Science's journal PloS Medicine.

In the article, Lemmens and his colleague Prof. Simon Stern argue that legal remedies are needed for medical ghost writing since medical journals, academic institutions and professional disciplinary bodies haven't succeeded in enforcing sanctions against the practice.
Ghost Writers make over $100,000 a year and if an article makes its way into a prestigious medical journal — like the Lancet, British Medical Journal, or The New England Journal of Medicine —that will earn up to $20,000 in an extra bonus payment.
“You’re being told what to do and if you don’t do it, you’ve lost the job”, said one ghost writer interviewed for a US TV segment.
“As long as I do my job well, it’s not up to me to decide how the drug is positioned. I’m just following the information I’m being given.”

 Once the article is written to the pharma company’s satisfaction, the pharma company then starts "shopping around" for an academic physician or physicians that are well known in the field, encouraging them to put their name on the article.

From there, they "massage" the article past peer review in one of the more prestigious medical journals, preferably one that strongly influences practicing doctors. Once the article is published, the pharmaceutical company then purchases tens of thousands of reprint copies to be distributed to doctor's offices by their pharmaceutical representatives. The unsuspecting doctor thinks the study is reliable since it clearly appears to be written by a leading name in the field, and has been published in a prestigious peer-reviewed medical journal.

Why would medical journals play along with this apparent sham?
Why aren't they doing more to eradicate this practice?

Perhaps the primary incentive to turn a blind eye is that it's very lucrative for them, as the reprints purchased by the pharmaceutical companies for distribution are quite expensive. And medical journals are, after all, for-profit businesses.
All these costs are added into the selling price for the drug, so it follows that if these practices were disallowed, there would be a facility to reduce drug prices by a large amount.

Even the institutions have divided loyalties which may explain why they've been slow to act.
For example, universities wish to protect academic integrity while also protecting their employees from unjust accusation.

It is thought that a legal response could act as a powerful deterrent. Even if the data in an article appearing in a peer-reviewed journal is accurate, misrepresentation of authorship still constitutes medical fraud.

Doctors, pharmacists and patients perceive published studies to be independent assessments made by academic experts.
The plot becomes even murkier, if ghost written publications are used in a court of law to support a manufacturer's arguments about a drug's safety and effectiveness.
Building on this deceit, academic experts who appear as witnesses for pharmaceutical and medical device companies also boost their credibility with these fraudulent publications on their CV. It’s a corrupt circular problem that has no end.

Lemmens and Stern suggest that imposing legal liability on guest authors in the U.S. "may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO)."

The policy paper and a related conference held at the University of Toronto in May were supported by a grant from the Social Sciences and Humanities Research Council on the Promotion of Integrity in Biomedical Research.

Summary:

* Ghost writing of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal disputes.

*Medical journals, academic institutions, and professional disciplinary bodies have thus far failed to enforce effective sanctions.

* The practice of ghost writing could be deterred more effectively through the imposition of legal liability on the “guest authors” who lend their names to ghost written articles.

* A guest author's claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims (in the US) that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).

* The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghost written articles in litigation. This claim also appropriately reflects the negative impact of ghost writing on the legal system.

In Conclusion:

Doctors today commonly assert that they practice "scientific medicine," and patients think that the medical treatments they receive are "scientifically proven".
 However, this ideal is a dream, not reality, and a clever and profitable marketing ruse, not a fact.

The British Medical Journal's "Clinical Evidence" analysed common medical treatments to evaluate which are supported by sufficient reliable evidence (BMJ, 2007). They reviewed approximately 2,500 treatments and found:

• 13 percent were found to be beneficial

• 23 percent were likely to be beneficial

• Eight percent were as likely to be harmful as beneficial

• Six percent were unlikely to be beneficial

• Four percent were likely to be harmful or ineffective.

• 46 percent were unknown whether they were efficacious or harmful

In the late 1970s, the US government conducted a similar evaluation and found a strikingly similar result.
They found that only 10 percent to 20 percent of medical treatments had evidence of efficacy (Office of Technology Assessment, 1978).

It would appear that the conventional medical model, from start to finish, is pervasively corrupted with massive conflicts of interests that make it exceedingly difficult to make a rational decision in health matters.
One of the biggest complaints the conventional medical industry has against alternative medicine is the lack of scientific research to support their practices.
This perception needs to be revised and the medical house put in order before criticising other health practitioners. Pharmacists have been continually criticised by medical practitioners along similar lines – it is time to reject these claims, but it is also time for pharmacy to update its own clinical model.

The scientific method works and I personally uphold its principles, but it has been so perverted by corporate interests, that it becomes very difficult to find the truth.

If pharmacists are to be successful in developing ethical clinical practices, they will certainly need to be vigilant in their professional processes. They will need to establish and maintain their own databases of clinical evidence and have input into the TGA database when it emerges.
The lack of integrity in the whole of the medical industry, including pharmacy, also needs a revision. The November edition of i2P featured four articles involving pharmacist integrity or integrity-related issues.
It is suggested to pharmacists that you print out all relevant articles relating to integrity, medical fraud and evidence-based practice and use them as a reference base to re-invent your clinical practice for the year 2012.
That year looks like being a watershed year for pharmacy with continuing bankruptcies, a major round of unemployment for employed pharmacists and no business plan in place to develop clinical practices with new income streams.
There will be financially-generated pressures to cut corners – don’t be tempted.

And have a happy New Year!

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