Pharmaceutical-Based Palliative Care – Looking beyond the Marketing.

 by Ian Maddocks

I want to dedicate this talk to a remarkable family doctor working in South Australia. His name is Peter Mansfield, and I remember him well as a medical student at Flinders University. Because I had worked in Papua New Guinea, he came to me in 1981 when he was looking for an interesting elective – and we discussed what he might do if he had an opportunity to go to a developing country. He was able to spend time in Bangladesh, and what he saw there alerted him to a very serious problem in drug use and drug advertising in the developing world.

He saw, in a situation of great poverty, desperate families making great sacrifices to purchase quite inappropriate medicines:

              Anabolic steroids for malnourished children

              Glucose solutions for infant feeding

              Tetracycline syrups for children’             

              Breast milk substitutes

He formed an organization: MaLAM: Medical Lobby for Appropriate Marketing, and encouraged his supporters to write letters to question drug companies about what they were doing in the Third World. (1)

There were some immediate effects:

In 1986, he asked a company for evidence to support the use of a mixture of arsenic, strychynine, vitamins and alcohol sold in Pakistan for stress. It was withdrawn immediately.

In 1991, MaLAM was able to stop the sale in the Philippines of a streptomycin chloramphenicol mixture that had become the popular over-the-counter medication for infant diarrhoea.

 

Since that time, Mansfield has directed his attention more globally. Under the by-line “Healthy Skepticism” he has continued to encourage doctors to become better informed about the drugs they prescribe, and he continues to question misleading advertising by pharmaceutical companies. He is an important example and stimulus encouraging doctors to develop skills in critical appraisal.

This has led him to cooperate with a growing number of medical leaders and commentators who ask serious questions about how doctors are influenced by the attentions they receive from drug companies. There is an increasing unease, around the world, about many of the techniques commonly used by drug companies to make particular products preferred by prescribers.

Take the matter of gifts received from company representatives. A gift, says Mansfield, is more than a nicety, it creates a social contract, with reciprocal obligations. (2) A gift is hard to refuse – refusal seems to imply rejection or hostility, and doctors (like other persons) like to be seen as nice to people. And a gift demands some reciprocity, some service in return. So evidence has accumulated that pharmaceutical gift-giving influences prescribing. The size of the gift does not seem to matter. A pen or a notepad may suffice. “When informational messages are mixed with food, flattery friendship or sex appeal [many company representatives are young  and female], critical thinking can be derailed”. (2)

Mansfield and Vlassov recently examines 397 drug advertisements in Russian medical journals. (3) Their findings included:

              Generic names were used in only 40% of the advertisements

              Only 45 % mentioned any indication for the drug

              Only 11% carried any warning or contraindication

              Only 5% mentioned potential interactions

              Only 2% provided references.

The information the advertisement carried most clearly was the trade name of the drug – the aim was to get that into the medical mind. The article comments that advertising is relatively new in Russia, not having been used in the Soviet era. Doctors are not being trained to evaluate drug advertisements and are ill-prepared for developing the critical appraisal necessary to evaluate information. Although there were laws in Russia about advertising, no action was being taken against illegal advertising. Without adequate penalties for illegal commercial practice, drug companies are unlikely to change their methods.  Further, there is a relative lack of collective action by doctors in Russia, and little leadership in arranging cooperation for protest or review of common but dubious practice.

It was noted that low incomes make medical specialists vulnerable to be encouraged to use their influence for drug promotion, to sell drugs themselves, to accept rewards for prescribing particular medications.  They are also given financial encouragement to participate in uncontrolled trials, and  companies can use the dubious results of these in their advertisements to promote a particular drug.

Medical journals in countries like Russia are poorly funded, and willingly accept such articles when they accompany advertisements that support the continuation of the publication.

How is this movement encouraging “healthy scepticism” being taken up in more technically advanced and affluent countries, and what relevance does it have to palliative care, and to palliative care in Malaysia?

A Close Relationship

Medical practice in almost every area has become closely linked with pharmaceutical company marketing.  It is common for prescribers to state that they feel quite free from influence by pharmaceutical companies concerning their choice of medications. But the available evidence suggests that this is a delusion, a comfortable protection against any charge of conflict of interest. 

Some degree of what has recently been termed ‘entanglement’ is very common in Australia, particularly with regard to:

              Free items (pens, desk top articles) given out in consulting rooms, conferences,    trade exhibits;

              Free lavish dinners at which a promotional talk occurs;

              Assistance with travel to sponsored meetings; luxury accommodation provided;

              Generous gifts – wine for Christmas, items for doctor’s wives.

In another country it was claimed that up to 50% of physicians had received an overseas trip, and nearly one half of those free trips were to meetings sponsored by the company underwriting the travel. (4)

Another estimate suggests that there is one pharmaceutical sales person for every 4.7 doctors in the US.  Drug marketing is a huge business.

A drug company may spend over one third of its revenue on marketing. This will be most evident in a country where it is cost-effective to heavily promote drugs because the general public can afford to satisfy an apparent need for daily medication (often through government subsidy of many medications). There are other countries where the marketing may be less intense, because there is no government subsidy, and much less money to go around, but Mansfield’s work suggests that what is marketed may be even more questionnable.

What drugs are really necessary? WHO has issued lists of recommended pharmacopoeia in an attempt to encourage an emphasis on medications that address important causes of mortality and morbidity. Those lists will not appeal to drug companies, because their prime interest is not a reduction in morbidity but an increase in company profit.

They are more interested to promote, in developed countries, the so-called life-style drugs, items which can hardly be called life-saving (5), but are clearly lucrative items for the companies that market them:

• Finasteride for baldness
• Botox for wrinkles
• Bupropion to aid cessation of smoking
• Paroxetine for social phobia (shyness)
• Orlistat and other weight loss medications
• Growth hormone for short stature
• Silenafil for improved sexual activity

 

Some change is needed in the relationship

 Doctors do need up-dating and continuing education, and medical research needs to be done, but must it be so dependent on support from companies whose prime aim is not improved health, but improved profits for their shareholders?

Some medical observers are concluding that the almost universal acquiescence of the medical profession in this dance with the drug companies (referred to recently as ‘dancing with porcupines’ – you can’t avoid being pricked) cuts across the physician’s primary duty to the patient. (6)

Most doctors think that free pens, textbooks, free lunches and happy hours are OK. But anyone who has accepted food, flattery and friendship (the three drug company “f’s”) will find hard to say critical things about the product being mentioned. And there may be a friendly suggestion that a medical recipient of drug company hospitality could do more, such as:

              Influence a hospital to obtain and use a particular drug formulation;

              Highlight particular trade names at lectures to undergraduates.

One of my friends, a clinical professor at Flinders University, has been a fine example of resistance to drug company pressure. He will not speak at a meeting sponsored by a drug company; he will not accept a drug ompany’s dinner or a gift, nor allow it to pay for any travel.

My own relationship with drug companies is far less exemplary, reflecting my perception of a wide range of gray areas in which there are a variety of common practices that often many doctors or most doctors in Australia would suggest are acceptable, but which a more rigorous ethical view might well condemn.

But one I will mention as an example that gives me no cause for pride or satisfaction.

I was asked to deliver special lecture at a conference in Asia in 2005 featuring oxycodone, and generously rewarded by the marketing company.  I explained to the big audience (they were receiving a free lunch) some of the advantages claimed for oxycodone and its controlled-release formulation Oxycontin  that was eginning to be introduced in that country. I discovered, however, immediately after completing the lecture, that the company providing the lunch and paying the honorarium marketed both Oxycontin and MS Contin, but were charging twice as much as for equivalent doses of Oxycontin compared to MS Contin, so naturally wanted everyone to shift to their newer opioid. I had been used as a marketing advocate.

There are some particular problems for Palliative Care in many parts of East Asia

1. Companies prefer to promote only expensive formulations, eg fentanyl patch, not morphine syrup, an excellent cheap analgesic, but not so profitable.

2. In some centres there is a greater risk of bribery to encourage official licensing of selected items;

3. On the world scene, minimal research is being done to develop drugs for the major health problems of the developing world;

4. The AIDS epidemic not being tackled effectively in many areas; no affordable drugs are available in many communities;

5. There is little continuing education for health staff from unbiased sources, forcing reliance on drug companies for information;

6. Many governments still refuse to license cheap oral opioids, fearing illicit use, and there is no push for these from the companies nor any cooperative pressure from the medical profession.

7. Common myths concerning pharmaceutical preparations (some of these myths promoted by the companies) may be more likely to receive acceptance in countries that lack sceptical commentary:

• New drugs are better (in fact they are rarely better)

• Expensive formulations are superior (not necessarily, just newer)
• Injected drugs work better than oral drugs (in most circumstances, no)
• Patch formulations are better than oral controlled-release preparations (each formulation has advantages, it depends on patient need)
• Slow-release drugs are better than acute-release. (Both are desirable for good pain management)

 

I once heard the prophetic figure Ivan Illich state that under the Allende government in Chile, no drug was licensed that had not been used for 17 years in the USA. Chile did not miss out on anything vitally important for health care, and it avoided a number of drugs that were later withdrawn because of long-term side-effects.

 

What Redress is being Suggested?

 Drug companies and the profession need each other, but do not have to be in bed together. We need to foster a relationship founded in trust, but a trust that stems not from the receiving of the three ‘f’s, but from open and objective evaluation of what pharmaceuticals are best for our patients and for our ethical medical practice. So to establish an ethical working relationship, several bodies and a number of leading physicians in developed countries are suggesting some ground rules:

eg. The Association of British Pharmaceutical Industry) stipulates: (7)

• Gifts from companies should be less than $9, relevant to doctor’s work

                 So: Pens and calendar are OK, Music CD’s and golf balls are not.

• Hospitality for meetings ought not exceed what recipients would expect if paying for themselves.
• Conference venues will not be chosen for their recreation facilities (eg by a golf course)
• Travel < 4 hours duration should be economy class.

The Royal Australasian College of Physicians has issued a comprehensive set of Guidelines. (8) Its many statements include:

• Acceptance of drug samples from pharmaceutical representatives should in most cases be avoided.
• Any acceptance of offers of sponsorship to attend conferences or scientific meetings should be disclosed to committees overseeing “conflicts of interest”.
• Speakers at a meeting planned by any organization should be required to disclose any dualities of interest at the time of their presentation.

 An Issue of the British Medical Journal, May 31, 2003,  was devoted almost entirely to this issue. (9)  It included two papers by Moynihan setting out the risks of Entanglement and rules for Disentangling from the corruption of the Drug Companies. (10, 11) Perhaps many of these difficulties and the need for adjustment to meet them do not apply in Malaysia, but they may be worth airing:

Ways of entanglement   

 Face to face visits – giving up time for drug  reps.         

Acceptance of direct gifts – equipment, accommodation, travel holidays  

Acceptance of indirect gifts – sponsorship of software, educational travel          

Attendance at sponsored dinner                                                                       

Honoraria for speaking                                                                                     

Attendance at sponsored education        

Ownership of stock                                                                                          

Sponsored research                                                                                             

Favouring a particular trade name                                                                     

Relying on free Newspapers funded by adverts                                                 

Company funding of education resources  – eg lecture theatre 

Inviting sponsorship of an organization    

Being an advisor to a sponsored foundation, patient group                                                                            

Paid consultantcy work for company                                                                

Membership of a thought leader group, or  authoring a ‘ghost-written’ article

Medical Journal reliance on advertising, sponsored supplements

                                                                                                                           

Paths to Disentanglement                                                      

Restrict visits to doctors

Campaign to end all gifts

Accept no free lunches

Campaign to end honoraria for speaking

Prohibit company-arranged education

Acknowledge, avoid conflict of interest

Prohibit research involving conflict of interest. Limit company funding by advocating national funding for research

Prefer generic names at all times

Avoid free literature, promote objective information (on-line?)

Foster independent funding for education

Stop acceptance of support by professional bodies

Acknowledge, avoid conflict of interest

Reduce reliance on advertising in journals

Palliative Care services have prided themselves on taking a high ethical stance in relation to matters of information and disclosure, consent, patient autonomy and family inclusiveness. I regard Malaysia as leading East Asia in its attention to ethical practice and the proper use of drugs.  You can maintain that reputation by taking some care in how you engage with and are engaged by your colleagues in the pharmaceutical industry.

References

 

1. Mansfield PR. MaLAM, a medical lobby for appropriate marketing of pharmaceuticals. Med JAust 1997; 167:590-592.
2. Katz D.  Mansfield P. Goodman R. Tiefer L. Merz J. Psychological aspects of gifts from drug companies.[comment]. [Comment. Letter] JAMA 1993; 290(18):2404-5.
3. Vlassov V.  Mansfield P. Lexchin J. Vlassova A. Do drug advertisements in Russian medical journals provide essential information for safe prescribing?. [Journal Article] Western Journal of Medicine 2001; 174(6):391-4,
4. Gudmundsson S. Doctors and drug companies: the beauty and the beast?  Acta Ophthalmol. Scand 2005; 83: 407-408
5. Lexchin J. Lifestyle drugs: issues for debate. Canadian Medical Association Journal 2001; 164(10): 1449-1451
6. Wager E. How to dance with porcupines: rules and guidelines on doctors’ relations with drug companies. BMJ 2003; 326:1196-8
7. Code of Practice Authority: Notes for Health Professionals. Association of British Phamraceutival Industries, 2006. http://www.abpi.org.uk/links/assoc/PMCPA/PMPCA.pdf.
8. Royal Australasian College of Physicians. Guidance for Ethical Relationships Between the Medical Profession and Industry. Third Edition, 2005.
9. Smith J. Food, flattery and friendship. BMJ 2003; 326:1154
10. Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies, 1.entanglement. BMJ 2003; 326:1189-92
11. Moynihan R. Who pays for the pizza? Redefining the relationships between doctors and drug companies, 2. Disentanglement. BMJ 2003; 326:1193-96