Healthy Skepticism International News

Abbott Claribid (clarithromycin)

October 1998

Vol 16 Issue 9/10 Abbott's promotion of Claribid (clarithromycin) in India: An example of the use of gifts

The use of gifts in India.

In March 1998, we received a letter from the Community Development Unit (CMDU) West Bengal expressing concern about the unethical use of gifts and requesting our assistance. CDMU are concerned about the use of cocktails and dinner at the Park Hotel Calcutta and a “bumper lucky draw” in the promotion of a paediatric formulation of clarithromycin by Abbott. (See Illustration 1 on page 3.)

Gifts are a powerful method of influence. [1,2] We are particularly concerned when that power is combined with unjustified claims. This month’s letter asks Abbott to justify or correct the impression that the company is promoting Claribid as the first line antibiotic for common paediatric infections.

The use of gifts in Pakistan.

Pakistani pharmacist, Dawood Kamal, has reported that:

“Most drug manufacturers in the country promote their drugs unethically. One way is to provide gifts to doctors in the form of airconditioners, televisions, VCRs, furniture, etc. In addition to multinational firms, local firms are also doing the same for their products’ promotion.” [3]

A brief history of gifts

The use of gifts to manipulate targets is not new. Consider:

The Trojan Horse.
The purchase of Manhattan from the local Native Americans in 1626 by Peter Minuit using trinkets valued at about USD $24.
In 1927, Claude C. Hopkins, one of the fathers of modern advertising, wrote in his autobiography that:

“The advantage to myself was covered up in my efforts to please…

I have always applied the same principle to advertising. I never ask people to buy. I rarely even say that my goods are sold by dealers, I seldom quote a price. The ads all offer service, perhaps a free sample or a free package. They sound altruistic. But they get a reading and get action from people seeking to serve themselves. No selfish appeal can do that.

Today that same principle is widely applied to house-to-house canvassing. Sellers of [cleaning] brushes call to offer the housewife a brush as a gift. Sellers of aluminum ware present a dish. Sellers of coffee call at first with a half-pound free package to try. They are always welcome. The housewife is all smiles and attention. Then, in the natural reaction, she strives to find a way to reciprocate the courtesy by buying.” [4] (emphasis added)

In 1992 Orlowski and Wateska asked 10 physicians in Cleveland if they believed they would be influenced by attending all-expenses paid trips to popular sunbelt vacation sites to attend pharmaceutical company funded symposia about two drugs.[2] The physicians’ beliefs are presented in table 1 below:

Table 1. Responses of physicians about the likely effects of enticements on their prescribing patterns.

Would not influence Unlikely to influence Could possibly influence
Drug A 9 1 0
Drug B 8 1 1
However those physicians were influenced as can be seen in table 2 below:

Table 2. Prescribing before and after a gift.

Usage before
(average units per month) Usage after
(average units per month) p
Drug A 81 272 <0.001
Drug B 34 87 <0.001
In the Orlowski and Wateska study the significant increases in prescribing commenced after the invitations were received and before the symposia occurred.

In 1995, Roughead analysed audio-tapes of 16 visits by "drug reps" to GPs in Melbourne. She reported that: "Reciprocation was the most commonly observed method of influence. Acts of reciprocation which were recorded included; sample supply or offer, gifts, printed material, patient information leaflets and invitations."[5]

In 1997, Sweet reported that: "The industry also uses more subtle techniques to build relationships with doctors. Karen, a nurse, spent six months a few years back working for Merck Sharp & Dohme, in a big program that offered GP’s patients free screening for heart disease risk factors. Those with elevated cholesterol or a combination of other risk factors were referred back to their GP. "They promoted it as a genuine, hands-off exercise, but as things developed, I felt it was more of a public relations exercise and a way of getting patients onto their (Cholesterol-lowering) medication" she says". [6]

In March 1998, MSD (Australia) was refreshingly frank about the company’s expectations for reciprocation. In a letter to Australian doctors regarding higher prices for MSD Australia’s drugs, Managing Director, Will Delaat wrote:

"We place a high priority on offering quality medical education activities and programmes. Initiatives such as the MSD HeartCare Programme, the University Programme, the Rural Health Education foundation and the GP teaching faculty are evidence of this commitment.

In short, we believe that every Australian deserves the right to quality healthcare, both now and in the future. We ask your support in prescribing MSD products, so that we can continue to work towards achieving this."

We need to think about how patients feel about paying extra to cover the cost of drug companies’ gifts for doctors because the effect of the gift is an influence that may not be in the interests of the patient.

The use of gifts in Australia.

During January to September 1998 the gifts offered to Australian GPs included: “Therapeutic Guidelines – Antibiotic”, a trip to Venice, socks (with pictures of a drug delivery device on them), a AUD $10,000 scholarship, a thermoscan, a home theatre system, and a silver plated cake server!

In July 1998, we received a copy of the following letter to the Australian Pharmaceutical Manufacturers Association.

Dear Sir/Madam

I would like to make a complaint about this invitation for a pharmaceutical company promotion I have received recently. [See Illustration 2 on page 4] In the guise of launching a new drug, this company is prepared to provide quite lavish entertainment for obviously many doctors and their partners and I presume the educational content of the evening would have been quite marginal. I think this is a completely inappropriate form of promotion by a pharmaceutical company and one that should be discouraged.

Regards.

Yours sincerely,

PETER DAVOREN
Staff Specialist
Gold Coast Hospital

As of 14 October 1998, the APMA have not yet reached a judgement on this complaint.

Readers can help overcome the harmful effects of gifts by signing this edition’s support letter and by refusing to accept gifts.

Illustration 1

Illustration 2

October 1998

Mr Duane L. Burnham,
Chairman and Chief Executive Officer
Abbott Laboratories.
Abbott Park,
Illinois,
U.S.A.

re: the promotion of Claribid (clarithromycin)

Dear Mr Burnham,

M. Sarkar, Associate Secretary of the Community Development Medicinal Unit (CMDU), West Bengal, India has asked MaLAM to investigate the promotion of Claribid (clarithromycin). CMDU expressed concern about the “bumper lucky draw” incentive for doctors to attend the promotion campaign launch in Calcutta on 18 October 1997. We are also concerned about your company’s advertising claims for clarithromycin as follows:

“Paediatric suspension ...speed,...strength,...spectrum,...safety.”

Those words are not qualified in the advertisement. Consequently, in our opinion, it would be reasonable for readers to interpret those words to mean that Claribid has clinically important advantages over alternative antimicrobials and thus is the first-line antibiotic for common childhood infections. Common examples of such conditions include otitis media, pharyngitis and sinusitis.

Comparison of your claims with initial conclusions based on the scientific literature available to MaLAM, summarised below, raises some questions. This letter is intended to give you the opportunity to express your point of view so that we can assess whether that claim assists appropriate therapy. We hope that you will either provide evidence to support your claims or reconsider the promotion of Claribid. We are optimistic that dialogue can lead to improvements in pharmaceutical promotion to the benefit of the public, health professionals and your company.

Initial conclusions from our review of the scientific literature.

MaLAM has consulted a number of authoritative references for treatment of otitis media, pharyngitis and sinusitis and has been unable to find any mention of Claribid as first-line antibiotic for any of them. The use of antibiotics for those conditions in wealthy communities is now controversial. However in places like West Bengal, use of antibiotics may be appropriate for many patients. Because the promotion occurred in West Bengal the following discussion will assume that use of an antibiotic is appropriate.

Otitis Media

A recent review by Rosenfeld on the treatment of otitis media listed amoxycillin and trimethoprim-sulfamethoxazole as first-line antibiotics with clarithromycin as one of eight second-line choices.[1] Both the Medical Letter [2] and the Ontario Anti-infective Guidelines for Community-acquired Infections [3] and the Australian Therapeutic Guidelines - Antibiotic [4] echo Rosenfeld’s choice of amoxycillin as the first-line antibiotic for this condition. In West Bengal the cost differential between amoxycillin and clarithromycin is substantial.

Pharyngitis

The first-line antibiotic for this condition is penicillin. This conclusion is shared by the Drug and Therapeutics Bulletin [5], the Ontario Anti-infective Guidelines for Community-acquired Infections [3], the Australian Therapeutic Guidelines - Antibiotic [4] and a literature review on this topic.[6] The Drug and Therapeutics Bulletin specifically compares clarithromycin to erythromycin and concludes that “newer macrolides such as clarithromycin cause fewer unwanted effects but are expensive and no more effective against resistant strains.” In West Bengal the cost differential between penicillin and clarithromycin is substantial.

Sinusitis

The Canadian Medical Association Journal recently published a special supplement on the diagnosis and treatment of acute sinusitis and recommended that amoxycillin should be the first-line antibiotic.[7] Clarithromycin was one of seven second-line choices. The Ontario Anti-infective Guidelines for Community-acquired Infections [3] and the Australian Therapeutic Guidelines - Antibiotic [4] also recommend amoxycillin as the first-line antibiotic.

Summary

Although clarithromycin is effective for all three conditions it is not a first-line antibiotic for any of them.

Questions

What is your company’s position on the use of gifts to manipulate doctors?
Do you believe that Claribid is the first-line antibiotic for common childhood infections such as otitis media, pharyngitis and sinusitis?
If your answer to question 2 is yes, then do you have clinical trial evidence of significant advantages in clinically important outcomes?
If your answer to question 2 is no, then what steps will your company be taking to correct misunderstandings which will have arisen from your promotion of Claribid?
5. Do you agree that it would be helpful for health professionals if your company’s promotional materials gave prominence to disclosure of important problems with your products equal to that given to claims of advantages?

6. What quality control procedures does your company use to check all promotional activities?

I look forward to receiving your answers to all 6 questions.

Yours sincerely,

Dr Joel Lexchin MD, CCFP (EM), DABEM
Secretary, MaLAM Inc

October 1998

Mr Duane L. Burnham,
Chairman and Chief Executive Officer
Abbott Laboratories.
Abbott Park,
Illinois,
U.S.A.

re: the promotion of Claribid (clarithromycin)
Dear Mr Burnham,

I have read the October 1998 MaLAM edition. q

(Please tick where appropriate)

I am a: doctor q

pharmacist q

nurse q