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The Struggle For the Patient
October 2008 -- The European Commission is willing to allow the pharmaceutical industry to directly inform patients on prescription medicines. Public health services in the member states are fiercely opposed against this business plan of the Directorate-General Enterprise: one cannot expect the information supplied by pill manufacturers to be impartial.

Written by Marleen Teugels, Joop Bouma and Brigitte Alfter

Soon to be seen on the internet or on your television’s shopping channel: a doctor and a patient discuss the treatment possibilities of breast cancer. ‘There are a lot of new treatments,’ says the doctor and the possibilities are displayed on the screen. The viewer can click and get information on the latest medicine for every treatment. This information is being supplied by the pharmaceutical industry.

This is what European medicine manufacturers dream of: Pharma TV, an interactive digital channel for patients looking for information. Packed with information on the newest medication. Yet opponents are afraid that the side effects, the poor experience with the medicine as well as alternative – maybe even more effective treatment methods – will not be mentioned.

On behalf of the European Commission four pharmaceutical companies – Johnson & Johnson, Pfizer, Novartis and Procter & Gamble – recorded a pilot dvd of Pharma TV, broadcasted in Brussels in May 2007. It so happened that Sarah Boseley, editor health care of the British newspaper The Guardian was there; she didn’t get a copy of the dvd but wrote on it in the newspaper.

Knack tried to get hold of a copy based on the regulation on the public nature but the European Commission replied that it also hadn’t got a copy. Johnson & Johnson didn’t want Knack to see the dvd. ‘It seems to be impossible. It is a work tool,’ states Stef Gijssels, vice-president Affairs at Janssen Pharmaceutica, a subsidiary of Johnson & Johnson, the company that presented the dvd on a number of European discussion panels at the time. ‘The initial intention was to bring television on demand but because the opposition was too strong there was a change-over to an internet project. This is currently being discussed with the authorities and the patients’ association. As soon as we have this input the idea will be adapted and elaborated – or will be completely given up,’ says Gijssels who emphasises that in his company’s view the doctor remains to be the primary contact.

EFPIA, the European pharmaceutical industry’s umbrella organisation says that meanwhile the plans to launch Pharma TV are brushed aside. ‘We are not interested in television broadcasts. We don’t favour direct publicity which targets patients, such as in the US ,’ says Brian Ager who works as a manager. ‘It is ironic to see that anybody can have a website on drugs while the people that know drugs best, cannot. As an industry right now we are trying to repair a situation that has gone wrong. According to Ager the European Commission will take care of guarantees in order to have balanced information and to have thought for side effects.

Huge resistance

In autumn the European Parliament will vote on a proposition that will visibly increase the pharmaceutical marketing’s power. In Europe the industry is currently not allowed to have direct contacts with consumers and patients when it comes to prescription drugs but this will change when later the European Commission’s wishes will be supplied. The resolution will probably be started by the Commission in November together with another resolution that will give pharmaceutical companies more power in the field of drug safety procedures. Moreover on that occasion a motion to confine the growing sales of imitation drugs will be discussed.

There’s not much of a chance that this resolution regarding direct contacts between the industry and the patient will pass: the resistance is huge. The pharmaceutical industry itself and the European Patients Forum – the patients’ umbrella organisation which is funded by the industry’s money – are so to speak the only favouring parties. However the European industry lobby, supported by the Directorate-General Enterprise and Industry ( Enterprise ) presided by the German European Commissioner Günter Verheugen (SPD) is very influential. In October 2002 the European Parliament already did vote down similar plans persuasively but now these plans are stubbornly surfacing again. Umbrella organisations that were involved in the realisation of the resolutions were severely pressured and sometimes even suppressed in the course of the decision-making process.

‘We are part of the European umbrella of consumer organisations BEUC,’ says the Belgian consumer organisation Test-Aankoop’s Martine Van Hecke. ‘BEUC keeps us informed about the developments. We provide feedback. Just like any other organisation BEUC actively participated in the public consultations organised by the Directorate-General (DG) Enterprise with respect to the development of the new resolutions. However the remaining part of the procedure can be questioned. BEUC for example was not involved in the Pharmaceutical Forum, the think tank erected as a kind of counselling body some three years ago by the European Commission and which contained representatives of the various industries. BEUC was not at all amused to be suppressed from the Pharmaceutical Forum. BEUC had not been invited and the reason why may be very obvious: unlike a lot of other parties BEUC is an independent body. Moreover there’s the problem of transparency since initially the reports were not published.’

Malte Enderlein who, being a former employee of the European Social Insurance Platform (ESIP) participated in the forum’s meetings, confirms that working within the Pharmaceutical Forum wasn’t easy. He speaks on his own responsibility. ‘Clearly there was a substantial difference between DG Enterprise and DG Sanco (the Directorate-General for Health and Consumer Protection, editorial note). Sanco emphasised the protection of the patients while Enterprise mainly had an eye for commercial aspects. The basic principle was to reinforce Europe as a manufacturer of pharmaceutical products. Reinforce the European competitiveness! This assumption had a decisive influence on the entire resolution.’

‘We have to admit that the industry excels in lobbying, both on a national and European level,’ says Enderlein. ‘Usually the Department of Economy is in charge and the Department of Public Health takes a back seat. The industry makes a parade of employment and provided that social insurers really do employ more people, it is still a fact that we don’t manufacture products. However we were able to achieve successes. In the discussions on the European Commission’s proposition to allow direct contacts with patients we have had a lot of difficulties to have the word “impartial” accepted in the text proposal. To achieve this we had even threatened to leave the study group. As a consequence the words “objective” and “impartial” (regarding information in behalf of patients) were introduced in the text but that had been extremely difficult to accomplish.’

Even the Dutch agency for rational use of medicines DGV, which advises the Dutch Secretary of Public Health concerning this subject, raises objections against the Pharmaceutical Forum, established by the Directorate-General to discuss the proposals. ‘Although patients have a seat on this, the forum is substantially dominated by the pharmaceutical industry,’ states the DGV in a formal reaction towards the European Commission. ‘Besides meanwhile it has become clear that the patients’ lobby keeps going on money of the pharmaceutical industry while European consumer organisations that were opposed to the plans were not represented.’

Novartis’ yellow devils

Health service authorities, health insurance organisations and consumer organisations are fiercely opposed to this plan. There are already too much examples of public campaigns with which the industry, balancing between what is allowed and what is not, has exalted relatively innocent diseases to severe disorders that need to be suppressed by taking pills.

Consider Diggy the dermatophyte – who doesn’t know this yellow devil? The creepy villainous creature in TV commercials that lifted toe nails and lavishly dived in exposed nail beds? Diggy is drug manufacturer Novartis’ cuddly toy. The nasty monster – although it horrified almost all European viewers – was a gold mine for the company.

Novartis manufactures Lamisil (terbinafine) against fungal nails. Usually this is a cosmetic problem. Until some years ago Novartis’ medicine against fungal nails was only to be had on prescription. Doctors only could prescribe the medicine.

In autumn 2004 and springtime 2005 Hodie Vivere, the non-profit Organisation for Prevention and Research on Diseases of Civilisation, launched the yellow-coloured Diggy devil on both of VRT’s channels in a ‘message of common interest’. Regarding the Flemish public broadcasting company commercial advertisers are only allowed to sponsor programmes and events. In this framework, on VRT they can only have broadcast time with short messages. Longer promos on VRT are allowed only on a non-commercial basis or when VRT products are involved. Such messages of common interest are considered very trustworthy by viewers. According to the Mediadatabank (MDB) the gross price of the investments for the fungal nail advertising spot amounted to around 250,000 Euro – a relatively large budget according to media planners.

The Diggy spot didn’t reference to Lamisil – as opposed to the American version where the little devil in some additional seconds is shown rolling with a large Lamisil pill. The Flemish version repeatedly states that fungal nails can be contagious and calls the audience to order a brochure and to discuss the issue with their doctor.

The effect soon made itself felt. Fungal nail patients massively went to the doctor who previously was bombarded by Novartis with glossy publicity brochures on Lamisil. These people were convinced to be a threat to their environment because of the fungal nails’ risk of infection. However every swimming pool is crawling with fungi. The best remedy against this is to wear slippers or have decent hygiene. At that time Lamisil was quite expensive yet even worse were the medicine’s serious side effects. (http://www.lareb.nl/zoek/geneesmiddel.asp)

While in autumn 2004 a ‘message of common interest’ most convincingly pushed fungal nails as a ‘serious danger to health’ another television campaign on the commercial channels (VTM, VT4, RTL-TVI etc.) gave additional product recognition to the over-the-counter Lamisil product. That advertising spot featured a handsome young man who suffered from athlete’s foot and consequently literally runs up the wall. ‘An itch? Irritated feeling? Athlete’s foot sometimes makes you run up the wall!’ says a voice-over. ‘Lamisil moisturiser gets rid of athlete’s foot in one week. (…) And now there’s also Lamisil spray.’ According to the MDB the cost price of the advertisement space reserved on the commercial channels in 2004 and 2005 amounted to almost 1.4 million Euro – comparable to media campaigns of ordinary consumer products.

The fungal nail spot on the VRT channels created ill-will among politicians like Magda De Meyer, Maya Detiège (both are members of the SP.A) and Dirk Van Duppen (PVDA). Furious doctors contacted Test-Aankoop requesting to take action. ‘We received spontaneous calls from doctors asking us to take action,’ said doctor Barbara Daled, head of Test-Aankoop’s Competence Centre for Nutrition and Health. ‘The doctors were paid a visit by upset patients after they had seen the spot on television. The doctors had also received representatives from Novartis with glossy leaflets full of product information. We have published a number of articles to this and we have filed a complaint with the Federal Economics Civil Service. Hodie Vivere, the non-commercial organisation that had paid for the spot display filed a complaint against us because we had pilloried them improperly but we were put in the right by the court.’

The Dutch Health Service Inspection summoned Novartis. According to the Inspection Novartis had unlawfully advertised for a prescription drug. The company was initially fined 86,000 Euro but the High Court turned down this judgment. So the company was cleared of the charge as a result of which in the Netherlands and its surrounding countries the coast was clear for pharmaceutical companies to pursue ‘symptoms advertising’ – advertising with conscientious omission of the brand but resulting in doctors that knew exactly what patients coming to surgery expected from them. Eventually the company was forced to his knees by an appeal of some doctors in North-Brabant to boycott all Novartis products. Novartis decided to stop the campaign.

The Belgian drug authorities agency FAGG didn’t act against the fungal nail spot broadcast. The website belonging to the campaign can currently still be consulted ( http://www.infomycose.info ). As a consequence of the fungal nail spot all advertisement spots dealing directly or indirectly with health, disease or vaccines first need to be submitted to a qualified control commission of the FAGG.

At that time the Jury for Ethical Practices concerning publicity (JEP) also didn’t raise its voice. ‘We did not receive any complaints in this matter,’ says Karin Laes, the Jury’s secretary. ‘In case the JEP would have received a consumer complaint then a file should have been opened for sure.’

Hodie Vivere, the non-profit Organisation for Prevention and Research on Diseases of Civilisation that reserved the spot had already been questioned in May 2003 in Knack magazine. In the past the organisation had received funding from cigarette giant Philip Morris to stage a number of seminars at the Université Libre de Bruxelles (ULB). The late chairman of the organisation, the emeritus professor Isidore Pelc (ULB, retired head of the CHU Brugmann Psychiatry department) even visited the Philip Morris plant in Neuchâtel together with two other members, one of them being Albert D’Adesky, at that time senior man of the Ministry of Health. Moreover Pelc was co-founder of the Rodin Foundation (at present CREAA) that contrary to the WHO’s recommendations and at the urgent request of Minister of Finance Didier Reynders (MR) organised smoking prevention campaigns funded by the tobacco industry.

The devil campaign didn’t do Novartis any harm. In 2004 and 2005 the sale of a prescribed Lamisil cure (in large 56-pills packing) peaked at 13.5 million and 14.8 million Euro respectively (of which 12.5 million and 13.5 million Euro – quite a sum to the taxpayer – to be paid by the RIZIV) (see separate article). From 2006 onward sales of this Lamisil packing dropped to 5.9 million Euro in 2007 (4.7 million of which was to be paid by the RIZIV). According to the RIZIV data from 2005 onward quite some cheap generic Lamisil variant drugs came onto the market. The publicity campaign might have been set up by Novartis in order to realise additional profits prior to its decline.

Information is also publicity

The yellow monster Diggy very soon received succession. As regular as clockwork the industry exalts quotidian discomforts of life to diseases that badly need to be treated: restless legs, nicotine addiction, menopause, obesity, urine problems, continuous worrying. Pharmaceutical companies are constantly inclined to push out frontiers when it comes to ‘advising’ patients.

‘It is hard to believe that pharmaceutical companies would supply impartial information to patients,’ says Marie-Louise Bouffioux of the federal drug authorities agency FAGG. ‘The reason for this is that the industry has to contend with a conflict of interests. The industry benefits from an increasing demand for drugs. It can be feared that the industry will supply information on novel medicines only. We are opposed to public publicity about prescription drugs and we think that advising patients isn’t the industry’s responsibility. We have communicated this viewpoint to the European Commission.’

‘Pharmaceutical companies depend on drug sales and the “good news show” directly influences the share price,’ states Bruno Toussaint, chief editor of the reputable French professional journal Prescrire. ‘That’s why they will expose their products.’

‘The information that is currently supplied by pharmaceutical companies on the internet and through other channels is biased,’ says Martine Van Hecke from Test-Aankoop. ‘They have largely proved to be unable to advise patients with independent unbiased information. It would be good for them to concentrate on what legally speaking are their actual objectives: to make the instruction leaflets more readable. Too often this leaves a lot to be desired.’

Moreover the quality of the written information that Belgian doctors nowadays get from the pharmaceutical industry is disgraceful by any standard. The messages have been investigated by the Federal Knowledge centre for Health Care (KCE). The findings from the inquiry that were published in June 2007 were appalling. Only one of six messages supplied to doctors was founded or based on the information leaflet.

Economy before health

Many European umbrella organisations find it unacceptable that basic aspects of the European health policies are influenced substantially by the DG Enterprise. It is said that the health of the European people would improve when drug policies would go from DG Enterprise to DG Sanco.

‘The importance of a good health care in Europe must not be made subordinate to the desire to reinforce the industry’s competitive position,’ is written by the International Society of Drug Bulletins in Europe (ISDB) in two substantial open letters to the European Commission.

‘The plan to let pharmaceutical companies communicate directly with patients on prescription drugs is a solution to a non-existing problem,’ says the Dutch agency for rational use of medicines DGV. ‘The directorate-general’s major objective is to stimulate the competition between entrepreneurs. As such the resolution is discredited already before the start.’

‘Here it is not a matter of establishing an information strategy for patients but it is about offering more opportunities for the pharmaceutical industry to enable direct contacts with patients regarding prescription drugs,’ says Ilaria Passarani of the European umbrella of consumer organisations BEUC. ‘The resolution will enable that the industry itself decides on what information will be supplied as well as on what diseases or drugs information will be given. This is certainly not in the consumers’ interests.’

The pharmaceutical industry deploys substantial lobbying techniques to allow direct contacts with patients on prescription drugs, for good reason. ‘Companies supplying information will always have to contend with a natural conflict of interests because in this matter drugs are involved which they have to sell,’ states a medicine expert of the Association Internationale Mutuelle (AIM) that at the same time is fiercely opposed to the industry’s direct communication with the patient. ‘The industry’s profits are dropping for some time now (*). Less novel drugs are being generated. The market is skimmed by generics. The drugs’ price decreases. The profits drop. This is one of the reasons for the pharmaceutical companies to have more publicity.’

‘What is supplied by the industry will be considered as information but it will always be publicity in disguise,’ says the AIM expert. ‘The patient often finds it difficult to distinguish between publicity and information. It is up to the authorities and care suppliers to advise patients on ailments and cures. The European Commission’s resolution assumes that the authorities will check the messages of the industry. However what about its capacities to do so? Who’s going to pay for that? Checking information on websites is practically impossible and besides usually this is done only after the online publication.’

(*) refer to http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=4883)

This is the first article in a series of four on drug safety in europe, a production of the Investigative Reporters Network Europe (Irene, www.irene-reporters.org ). This project was established with the financial support of the Pascal Decroos fund in Brussels and the Fund for exceptional Journalistic Projects in Amsterdam .

‘It is hard to believe that pharmaceutical companies would supply impartial information to patients.’

(Marie-Louise Bouffioux)

‘It is ironic to see that anybody can have a website on drugs while the people that know drugs best, cannot.’

(Brian Ager)

BOX

Under the Nails of the Tax Payers

In the period that fungal nails were pushed as a disease and Lamisil was supported as a brand, the federal RIZIV’s budget for reimbursement of Lamisil on prescription rocketed up. This large bill is actually to be paid by the tax payer. Compared to 2003 RIZIV’s budget in 2004 for Lamisil on prescription increased with more than 1.5 million Euro and in 2005 it went up with 2.6 million Euro – and this merely considering the large packings (containing 56 x 250 milligrams). The publicity campaigns have a positive influence on the number of daily doses and the number of patients that were prescribed Lamisil pills against fungal nails.

SOURCE FIGURES: RIZIV

For Sale: European Patient Lobby Group

European patient organisations serving as a spokesman for millions of ill Europeans are largely supported with money from the pharmaceutical industry. Consequently the very lobby power of the industry is being increased substantially in Europe. This is the second part in a series on drug safety in Europe.

Brigitte Alfter (Copenhaguen), Joop Bouma (Amsterdam), Marleen Teugels (Brussels)

An enormous amount of money goes to the patient lobby groups in the European Union. A good few European patient groups depend mainly on financial support of the pharmaceutical industry. Since its erection in 2003 the umbrella organisation for patients in the EU, the European Patients’ Forum, which is recognised by the European Commission, depends mainly on sponsoring by the industry. This is also the case for other patients’ associations (see separate article).

In Brussels alone the industry has stationed 50 lobbyists. All nine pharmaceutical umbrella organisations have 20 full-time representatives next to the 26 lobbyists that work for 13 major manufacturers. Moreover there is the influencing power of heavily sponsored patients’ associations.

The past year has painfully revealed in what the influence of the industry may result. The European coalition of breast cancer patients’ associations Europa Donna, of which Borstkanker Vereniging Nederland is a member, came into conflict with a group of European Parliament members. The politicians were distracted by the interrelation between this movement and the pharmaceutical industry and so there was a crisis of confidence.

The immediate cause was the increasing pressure on patients’ associations when it comes to transparency about their funding. More and more patient organisations reveal the names of their sponsors on their website and indicate the ratio of business contributions to the remaining revenues. And so does Europa Donna.

The 2007 annual report showed that 86% of the patient group’s funding was sponsored by the pharmaceutical companies, amounting to about 365,000 Euro on a total of more than 424,000 Euro.

Karin Jöns, a socialist member of the European Parliament, was shocked by the news. Years ago Jöns set up a division of Europa Donna in Germany. She is proud to say that the German patient group is functioning ‘without even one dime’ of the pharmaceutical industry. Jöns said that in the past Europa Donna had always claimed that maximum one third of its revenues came from the industry.

Jöns was one of the main initiators and is also chairwoman of the European Parliamentary Group on Breast Cancer. However a group of parliament members found the substantial sponsoring by pharmaceutics was a valid reason for instantly breaking off the ties with the patients’ umbrella group. “We abandon further cooperation with Europa Donna because the European umbrella organisation’s management has grown into a lobbying tool for the commercial interests of large companies. We know that the pharmaceutical industry adopts subtle methods to try to abuse more patient groups for their own interests.”

Currently Europa Donna is trying to win back the support of these parliament members. “They invited me for a talk,” says Dorette Corbey (PvdA), a Dutch member of the European Parliament. “They have a lot to explain. Breast cancer is obviously a major health problem. That’s why we keep demanding attention on it but this doesn’t necessarily imply that we need Europa Donna.”

In an article in the paper The Parliament Magazine Jöns says that patient groups never take action against the excessive prices of new medicines and only seldom pursue the efficiency of alternative, non-medication treatment options. “Patients’ associations need to be aware that they lose their credibility with politicians by accepting attractive financial sponsorship. This is not for their own good. It is perfectly possible to conduct a persuasive and successful campaign for breast cancer patients without the pharmaceutical industry’s financial support.”

However this view is questioned by Susan Knox, director of Europa Donna. “If you intend to set up all kinds of projects like we do, you simply need this funding from pharmaceutical companies. The European Commission cannot give us enough financial support and neither can the European countries. So then how are we supposed to come by money?” According to her the industry has no impact on Europa Donna’s policies. “We are absolutely free to spend our money as we wish and we have a decent management that sees to it that it’s properly spent.”

Karin Jöns is convinced that patients’ associations can operate without the pharmaceutical industry’s financial support. “This has been clearly shown by Europa Donna in Germany. We have set up a number of projects on our own. Of course it isn’t easy but it really is possible. The problem is that pharmaceutical companies may be criticised for abusing patient organisations yet it is even more reprehensible that patient groups let themselves be abused by the pharmaceutical industry. They are blinded by the money and they let themselves be bought by the industry.”

Jöns raises the question whether indeed patient organisations are apt to lobby for their own interests since emotion sometimes gets the upper hand. “Considering novel medicines patient groups will be the first to demand the instant availability for patients, no matter how expensive they are. Yet sometimes it’s better to let it rest for a while. It so happens that sometimes medicines already are available without solid evidence of effectiveness and safety. Susan Knox, a former breast cancer patient, tends to have a similar attitude. She always says: I’m a patient myself, I know what I’m talking about. Although I have had breast cancer myself I think it’s more sensible to maintain some distance and reflection.”

Still there are more shadowy relationships between European patient groups and the pharmaceutical industry. Manufacturers often have several advisory boards, mostly these are associated with a medicine. Doctors who in their field are considered an expert, have a seat on these boards and are being paid for this. Apart from medical problems the advisory boards usually also discuss marketing issues.

The GlaxoSmitKline (GSK) company’s Health Advisory Board is presided by Imelda Read (UK), a former Labour member of the European Parliament. However she is also president of the European Cervical Cancer Association (ECCA). This is a European cooperation of cancer centres and charity organisations that aims at an increased awareness of cervical cancer.

Read’s position as a counsellor of GSK and as president of a lobby group for tracing and treating cervical cancer may be questioned. In Europe GSK distributes Cervarix, a cervical cancer vaccine. GSK together with its competitor Sanofi Pasteur MSD (who produces the Gardasil vaccine) have heavily and successfully lobbied in the EU member states to obtain reimbursement of the vaccine.

At the same time both of these vaccine manufacturers sponsor Imelda Read’s European Cervical Cancer Association. As much as 52% of its revenues come from five pharmaceutical companies. Yet also the ECCA is campaigning for the vaccination against cervical cancer. Isn’t it complicated to be chairwoman of the ECCA and at the same time be a counsellor of a vaccine-producing manufacturer? Read doesn’t think so. “There’s no conflict of interests. I would have resigned if there had been a conflict. We simply advise GSK, we don’t discuss marketing issues in the advisory board.

Imelda Read is reluctant to answer questions regarding GSK’s Health Advisory Board. When asked about what exactly is being discussed in the board, she remains silent for a while. Then she says: “We examine medical inquiries and lots of things, such as the code of conduct that the European umbrella organisation for pharmaceutical companies established on the relationship between the business world and patient organisations.” She refuses to reveal who the other members are and she refers to GSK for further questions.

Read says that within the ECCA she has made no secret of her relationship with GlaxoSmithKline. Pathology Professor Dr. Chris Meijer, who works at the VU Medisch Centrum in Amsterdam, didn’t have knowledge of Read’s ties with a pharmaceutical company. Prof. Meijer is the Dutch representative on behalf of the VU Medisch Centrum in the ECCA. “I wish I’d known this before,” he says. “Full openness is needed when it comes to this kind of matter so others can form an opinion about a possible conflict of interest.”

GlaxoSmithKline refuses to disclose agenda’s and reports of the Health Advisory Board. “These documents come under confidentiality agreements signed by all attendant members,” states manager external affairs of GSK Europe Andrew Garvey in a mail. He mentions that the advisory board discusses issues such as improvements in the way that clinical trials are set up, or deliberating on ‘GSK’s code of conduct on contacts with patient organisations to guarantee a highest-level moral relationship’.

According to Garvey the members of the advisory body are recruited from a range of patient groups, ‘also for diseases in which GSK doesn’t have a therapeutic interest.’ Garvey says: “They come from well-known, reliable and independent patient organisations that are considered an authority in their field.” The members get 500 Euro per session ‘as a small remuneration for their time and participation,’ Garvey says.

In 2006 Clive Needle (UK), director of EuroHealthNet, a network of European organisations in the field of public health, for once attended a meeting of the GSK advisory board. He says: “The relatively short meeting confirmed my opinion that it is better to avoid direct contact with individual companies. Moreover the fact that I had to sign a requirement of confidentiality on everything that was discussed in the board didn’t make me happy either. However it was a useful experience because my understanding of the meaning of such advisory boards is somewhat better now: when considering the meeting that I had attended its meaning is very limited. Of course I have no knowledge of the informal relationships that are established between Glaxo and the patient groups as a consequence of such meetings.” And as it happens this might as well be the real agenda of GlaxoSmithKline.

This is the second article in a series of four on drug safety in Europe, a production of the Investigative Reporters Network Europe (Irene, www.irene-reporters.org ). The first article was published on October 2, 2008 (refer to www.trouw.nl/veiligepillen ). This project was established with the financial support of the Pascal Decroos Fund in Brussels and the Fund for Exceptional Journalistic Projects in Amsterdam.

Endless Pharma Money Flows, No Club Can Do Without

In 2007 the European division of the International Diabetes Federation (IDF) received four million Euro from pharmaceutical companies, which is 80 percent of total revenues. IDF’s website doesn’t make mention of this financial sponsorship. Luc Hendrickx, IDF director, says: “The website is just a little behind.”

Marleen Teugels, Joop Bouma and Brigitte Alfter

Last year the European Cancer Patient Coalition (ECPC) received about 95% of its revenues, more than 340,000 Euro, from the pharmaceutical industry.

Most of the European patient groups depend on pharma money. However the subscription fees paid by the members organisation in the EU countries are usually low. In 2006 the European cooperation of patient organisations for Parkinson’s disease received more than 200,000 Euro from pharmaceutical sponsors (70% of its total budget) yet the 37 associated Parkinson’s organisations were invoiced subscription fees of less than 13,000 Euro (which conforms to some 340 Euro per association per year).

The European Patients’ Forum (EPF), which in the EU is considered spokesman for ill Europeans, depends almost exclusively on financial support since its erection in 2003.

According to its own specification in 2007 the EPF has received financial support totaling 337,000 Euro. In the same year 25 members, amongst which there are several organisations having a turnover of millions, all together paid subscription fees of 5,000 Euro or 200 Euro per member association.

98 percent of the money to be spent by the EPF in 2007 came from pharmaceutical companies. In the same year apart from the sponsoring the Pfizer and GlaxoSmithKline companies donated 145,000 Euro to finance an EPF congress. And the European organisation of pharmaceutical companies EFPIA paid 75,000 Euro for an EPF seminar on the patient lobby.

However the EPF is an independent organisation according to its chairman Anders Olausen. “Our policies are driven by its members’ wishes. The EPF will never assume an industry or government viewpoint.” Olausen says that in 2009 the EPF aims at a 40% stake of its revenues coming from sources outside the industry.

Yet the European division of the consumer and patient organisation HAI (Health Action International) questions this European Patients’ Forum’s independence already since 2005.

The pharmaceutical sector is well aware of the risks and the possible image damage that may be caused by sponsoring patient organisations and so the umbrella organisation EFPIA established a code of conduct that guarantees the patient groups’ independence. Yet in practice the pharmaceutical companies adopt subtle methods to use patients in marketing campaigns.

Incidents with medication

In spite of the high mortality rate caused by the side effects of medication the pharmaceutical industry puts up a fight against the public accessibility of confidential reports containing listings and assessments of such incidents. The Belgian weekly Knack and the Dutch newspaper Trouw have published secret documents concerning the side effects of frequently prescribed drugs on their website.

In Europe problems with drugs are a common cause (see ‘Disgraceful Pills’, below). “We don’t know what the precise impact of a drug is on the health of millions of people. This will only become clear once a drug will be sold in large amounts,” says the Canadian scientist and assistant professor at the University of British Columbia Barbara Mintzes, an international expert in drug safety. Complete transparency about all the side effects is therefore unbearably necessary, in each stadium of the production process, from the early development phase, the tests on healthy and sick ‘test persons’ until the moment it reaches its way out to the public. All studies, publications and reports of side effects should be absolutely available to the public because they concern the health of millions of people. At this stage this is not the case and it has to change.”

Journalists are trying to turn the tide by making kept secret documents about these side effects accessible to the public. Knack and Trouw have put confidential information (the so-called Periodical Safety Update Reports, or PSURs) of frequently used drugs on their site. These are reports in which the pharmaceutical industry themselves have reported and assessed the side effects worldwide. These safety reports are used by the national drug authorities in the European countries to safeguard the security of the drugs. Except to them they are not accessible to others.

Depressed by acne medication?

In December 2006 the Danish journalist Ulrik Dahlin from the Danish paper Information was one of the first to throw down the wall of secrecy concerning those safety reports. In 2002 a young woman got severely depressed after a two-weeks intake of Roaccutane. This is a medication for severe cases of acne. Dahlin decided to use the Danish FOI to get access to the PSURs of Roaccutane (and of the active ingredient Isotretinoïne). Already in 2003 the Danish drug authorities wanted to give access to the PSURs but manufacturer Roche and the Danish umbrella organisation of the pharmaceutical industry Laegemiddel Industri Foreningen (LIF) protested. The arguments which the lawyers brought forward through the trial had nothing to do with public health. Roche commented that its competitors might use the data and weaken its market position. “This could lead to worldwide negative economical consequences for Roche,” wrote the Roche lawyer to the Danish drug authorities. Roche also claimed that the patients would not be capable to correctly judge the value of the documents. “Media attention for side effects”, the company lawyer stated, “could lead to the fact that patients would stop taking their necessary medication because of unjustified fear for side effects.”

Roche also wanted to keep the authors names of the PSURs and the unpublished studies secret because for the public ‘it is not important to know who contributed to the PSURs’. According to LIF making the reports of side effects accessible to the public would have a negative impact on the will to report side effects by doctors and patients.

It was only in August 2006 that Ulrik Dahlin got access to the PSURs about Roaccutane. Lots of data in the PSURs such as patients’ nationality, sex, age where totally blackened. But to Dahlin it was clear that more than one user of the acne drug got depressed. Because of crashing sales figures the drug was withheld of the Danish pharmaceutical market but in Belgium and in most other European countries it still is accessible.

Secret reports going public

Using the freedom of information act with the Danish and Dutch drug authorities Knack and Trouw have obtained confidential safety reports (PSURs) concerning the anti-psychoticon Seroquel, the antidepressive Tryptisol, the cholesterol reducer Crestor and the ADHD drug Ritalin and similar drugs containing methylfenidate. This information concerning the side effects of these drugs can be consulted online, see www.knack.be and www.trouw.nl .

All the PSURS have been released into the open, however incomplete. In some of the safety reports whole parts were blackened out. In the PSUR about the cholesterol-reducing drug Crestor – containing 900 pages – a lot of information (such as age, sex and country) was blackened. Since a lot of information is incomplete (such as the quantity of Crestor sold) it is very hard to draw conclusions about severe side effect such as life threatening forms of musculature waste.

Is it at all possible to obtain similar safety reports in other European countries? Knack and Trouw tested the facts in Holland. The aim was to start the FOI procedure to obtain the PSURS for the drugs Seroquel and Seroquel XR with the Dutch drug authorities CBG (College ter Beoordeling van Documenten) and make them public. These are two antipsychotic drugs from AstraZeneca. The Dutch drug authority claimed it would release the documents maximally. As little data as possible would be left out. But Astra Zeneca objected against the release. Because of this reason the documents were withheld for months. It was only in the beginning of September 2008, seven months after Knack and Trouw had begun the FOI procedures that the reports were released.

Knack and Trouw also tested the facts in Belgium. And are still waiting for an answer. At the beginning of June the federal drug and health products agency FAGG assured the files would be released after exclusion of confidential personal and company data. In mid-August the FAGG wrote in a letter it would first gain advice from the CTB commission (Commission for the access of state documents), the instance where civilians can go into appeal during an FOI procedure ‘because of difficulties with the interpretation of the federal Freedom of Information Act’. “According to advice the CBT has given in the past government agencies cannot ask for advice on pending FOI requests,” says FOI expert Frankie Schram (Catholic University of Louvain). How long this advice will be pending is unclear as CBT members are since May waiting for their nomination.

Sceptical about quality

Scientist Barbara Mintzes has looked into the thousands of pages of PSURs that have been made public by the drug authorities in Copenhagen and The Hague. ‘In these reports much too much has been blackened. The quality is unequal. It is of major importance that these safety reports can be accessible for everybody so that scientists can debate about the quality,” concludes Mintzes.

Margrethe Nielsen who works as a scientist with the Nordic Cochrane Centre, an independent research and information centre specialised in health care also claims that a debate on the reporting of side effects of drugs is essential. She’s investigating the PSURs that have been released by the Danish and Dutch authorities. ‘The whole system used for reporting the side effects must change. The fact that the pharmaceutical industry itself is investigating the link between its own products and the side effects is absurd. Under-reporting is also a huge problem: barely five percent of the drugs’ side effects are as today being reported.”

Experts of the independent French professional medical journal Prescrire have a lot of doubts about the quality of the PSURs that have been released. “PSURs must be accessible to everyone,” says chief editor Bruno Toussaint. “The reports are rather technical. The industry claims that the people wouldn’t understand them. In reality making the side effects public would influence the stock price in a negative way. This has already happened in the past.

According to Toussaint the blackening of the information in the PSURs is due to commercial self-interest. Why are the experts in the PSURs blackened? “Whenever the professor who comes to debate on television about a drug has a relationship with the pharmaceutical company involved he loses his credibility.”

The power of the stock exchange

The Health Action International (HAI) is a fierce defender for a better organisation of drug safety procedures which they call ‘pharmacovigileance’. “An independent system for the monitoring and assessment of drug safety is very important,” says Teresa Alves of HAI in Amsterdam, an organisation fighting for a more rational use of medicines.

“The industry has got information about side effects and we already know how good they are at withholding this from the public. This is the reason why Alves has great concern about a proposal from the Directorate General Enterprise and Industry (Enterprise) to give pharmaceutical companies more power in the area of drug safety. The proposition will be soon approved by the commission and will come forward for discussion within the European Parliament.

Alves comments: “When a new drug is being registered pharmaceutical companies would have to hand in less substantial safety studies. In exceptional circumstances the manufacturers would also be able to register medicines from which the effectiveness and safety have not yet been proved. This is a problem. In the proposal there is no explanation what those exceptional circumstances are. The drug authorities in the European Union may define this themselves.” Patients can also register side effects with the manufacturers. This is not according to Alves’s liking. “When doing assessments about side effects the pharmaceutical companies are having a fundamental conflict of interests. They have to gain money with products that can cause side-effects – which they themselves have to assess.”

Alves states the fact that there are good examples within Europe of an independent registration of side effects, using also patients reports. A good practice, according to Alves, is the Dutch centre of side effects Lareb. Since 1991 the centre has already received 75.000 reports, also by patients ( http://www.lareb.nl ). The Lareb site gives a clear view on all reported side effects, which can also be reported online. The Belgian FAGG is not as far advanced. It has yet much to learn. Recently it launched a sensibilisation campaign with 200 doctors and pharmacists for an online report system which will only be available in 2009. Lately Belgian patients can report side effects via the consumer organisation Test-Aankoop ( http://www.meldpuntgeneesmiddelen.be ). Until now it has had more than 400 complaints.

Bruno Toussaint, chief editor of Prescrire is against European plans to give the industry more power in the field of drug safety. “The companies must evaluate the side effects of their drugs and at the same time they have to earn big money for their shareholders. This is the key to the problem. The pharmaceutical companies will be inclined to minimise the side effects of their medicines and to underline the advantages. Drug safety in Europe is endangered.”

“For years the European Commission watches over the health of the pharmaceutical industry instead of caring for the health of the Europeans,” says Toussaint. Health care groups in most European countries are worried about the fact that drug policy in Europe falls under the supervision of the Directorate-General Enterprise and Industry (Enterprise), and not under the supervision of the Directorate-General for Health and Consumer Protection (Sanco). “This has dangerous consequences,” says Toussaint. “The same European directorate wants to give the industry the possibility to directly ‘inform’ patients about prescription drugs, while the American Food and Drug Administration (FDA) is attempting to put a limit on drug advertising.

( http://www.pharmalot.com/2008/09/fda-warns-five-drugmakers-over-adhd-ads/ ).

This article is a production of Investigative Reporters Network Europe (IRENE, WWW.IRENE-REPORTERS.ORG). This project was possible with the help of the Pascal Decroos Fund in Brussels and the Fund for exceptional journalistic projects in Amsterdam.

BOX

Disgraceful pills

Each pill can contain annoying and even life-threatening consequences. It is therefore absolutely necessary to obtain full information on all the side effects.

According to the Pharmaceutical Group of the European Union (PGEU) there is a mortality rate of nearly 200,000 people per year in Europe alone due to medication problems: over-dose or under-dose, wrong medication, incorrect use, etc. The same source reports that in Dutch hospitals 1,250 patients per year have deceased from medication problems that could have been avoided. These are more victims than traffic casualties in the Netherlands.

There is no shortage in the amount of scandals that concern medicines. For example a couple of years ago the manufacturer Merck had to withdraw the relatively new drug Vioxx off the market. A study showed that patients who had taken Vioxx during quite some time were at greater risk of getting a heart attack or a stroke. Worldwide the drug made hundreds of thousands of victims. Because of the sublime marketing strategy the drug was even prescribed for muscular pains after a tennis match, for which Vioxx wasn’t approved. According to scientists of the professional magazine The New England Journal of Medicine Merck was well aware of the side effects long before the drug got taken off the market, but the company masked the data. Therefore the Vioxx scandal was an even bigger catastrophe than the Softenon drama in the 1960s. Worldwide ten thousand babies were born with malformations after mothers had taken the drug against morning sickness or sleeping problems. This case led the governments worldwide to put up agencies for the safety and security of the medicines. But it hasn’t stopped catastrophes happening worldwide.