Drug Policy

Drug Policy

WHO Revised Drug Strategy Watch

Recent moves at WHO call for HAI action

While HAI has always kept a close watch on the World Health Organization (WHO) and has led efforts to advance the Revised Drug Strategy, important changes taking place within the past two months have intensified HAI's efforts. HAI's three regional offices agree that the network must respond to WHO developments that will affect the way in which the Action Programme on Essential Drugs and the Drug Management and Policies division function. HAI also wants to ensure that NGOs have a voice in the changes taking place.

As many HAI contacts may know, in July, WHO's new Director General, Dr. Gro Harlem Brundtland, appointed Dr. Michael Scholtz the new director of the cluster group "Health Technology and Drugs". Scholtz, a German national, joins the WHO after a long career in marketing and management within the pharmaceutical industry. When challenged about his commitment to lead WHO's drug policy in view of his background, Scholtz told the British Medical Journal "I used to say that when I retired, I would go and work voluntarily for the WHO to pay back society. This opportunity came along and fits my personal values. Now I don't have to wait to retire."

HAI and other public health NGOs and NGO networks have called for a consultation with Scholtz as he takes on his new responsibilities. The meeting's purpose would be to provide an opportunity to offer perspectives, expertise and suggestions for WHO to continue promoting rational drug use. It would also enable the new director to be more clear about his own views and priorities and learn about the priorities and capabilities of NGOs working in this field. HAI has offered to take the lead in organising such a meeting and hopes that it can coincide with the NGO consultation meeting Dr. Brundtland has tentatively scheduled for November.

Dr. Brundtland has already announced plans to hold a roundtable discussion with members of the pharmaceutical industry in October.

Scholtz will be asked to jump quickly into the world of WHO politics as the Revised Drug Strategy will be reconsidered later this year through a working group process set out at this May's World Health Assembly (see related article for more details). The HAI-Europe office plans to lobby representatives at the WHO-Europe Regional Meeting in mid-September which will address the Revised Drug Strategy and contacts from other regions will monitor and try to influence developments at their own regional meetings.

HAI will keep its members updated on WHO developments affecting drug policy and the network's actions as they occur. Those contacts interested in becoming involved in this campaign should contact the HAI-Europe office.

HAI lobby team member, Ellen 't Hoen, meets the new Director General at the World Health Assembly in May.

WHA ends without drug strategy

After a week of intense lobbying pressure from proponents and critics of the Revised Drug Strategy tabled at the World Health Assembly, the committee charged with considering the resolution was unable to reach consensus on a text (see HAI News, June 1998). A large part of the controversy arose when delegates from several developed countries objected to wording that would place public health interests above commercial interests. HAI and other groups which lobbied for the passage of the original draft text approved by the Executive Board in January, lobbied that championing trade priorities above health would be odd for a forum specifically created to protect public health.

As a result of this block on the resolution, it will now be brought back to the WHA's Executive Board and referred to an international working group to arrive at a consensus. This process will take place over the next few months. For more details about this process, contact the HAI-Europe office.

Social Audit demands access to UK drug licencing information

A debate between the chairman of the UK Committee on the Safety of Medicines (CSM) and Social Audit's Charles Medawar has led to renewed efforts by Social Audit to gain access to now secret information held by the committee. At a debate organised by the King's Fund, Medawar highlighted the agency's "secretive, unresponsive and unaccountable" actions and the consequences this had on public health, saying, "Over the years, there have been numerous, sometimes serious drug problems, but no public enquiry into drug safety has ever been held. This matters not just because it hides data and diminishes science, but also because it perpetuates two great vices in medicine-the belief that meaning well means doing good, and the consistent inability to admit mistakes and learn from them. Both should be counted as serious obstacles to patients' safety and public health."

He also pointed out the comfortable relationship between expert members of the CSM and the industry charging that most members now have direct or indirect financial interests in the companies whose drugs they are asked to evaluate.

While the CSM chairman, Michael Rawlins, echoed Medawar's concerns about secrecy during the debate, he noted that the current regulatory system ensures that the industry provides drugs of adequate quality which are effective and acceptably safe. He also disagreed with Medawar on questions about conflict of interest. Rawlins stated such problems were avoided through "strict arrangements for members to disclose their interests with individual companies" and, depending on the situation, to leave the discussion when such a drug is under review.

To follow up on the denials Rawlins made about avoiding conflicts of interest, Medawar asked him for evidence to verify his remarks. The Medicines Control Agency confirmed receipt of his request for information and promised to send a reply as soon as possible. Almost two months later, Medawar received a letter from Rawlins saying he refused to provide information answering his questions after discussing the matter with members of the CSM. In response, Medawar has now filed a formal complaint with the Parliamentary Commissioner for Administration, in respect of non-disclosure of information for four requests. Several others are outstanding.

For more information about the ongoing campaign, visit Social Audit's website: http://www.socialaudit.org.uk

(Correspondence with Social Audit and The King's Fund)

FDA promotes generics

A battle between a brand-name blood thinner and its cheaper, generic alternative has provided important support for generic drugs. In a letter sent to physician associations and state pharmacy boards, the US Food and Drug Administration (FDA) has said generics are just as good as brand-name drugs. "There are no documented examples of a generic product manufactured to meet its approved specifications that could not be used interchangeably with the corresponding brand-name drug," stated Dr. Stuart Nightingale, FDA associate commissioner.

DuPont Merck, the manufacturer of the blood thinner, Coumadin, has argued that its product is a "narrow therapeutic index" drug meaning that slight changes in dosage can be dangerous or make it ineffective. It has tried to convince states to ban pharmacies from dispensing the generic version unless both the prescriber and the patient agree. A number of states have already passed such laws and it is under consideration in others.

(Associated Press message on E-Drug)

Norway without its need clause

After ratifying the European Economic Area agreement in 1994, Norway was forced to remove its "need clause" when considering approval for pharmaceuticals. Practically, this agreement means medicines must be assessed solely according to the company's documentation about the drug's clinical effect, quality and safety. As a result, this change has led to the introduction of many "me too" drugs. The increase has been particularly high for drugs affecting the cardiovascular and central nervous systems. Other drugs have also been reintroduced, especially those used to treat high blood pressure. In addition, Norwegian professionals have raised concerns about the EU provision that allows approval of medicinal products with limited documentation about their efficacy. This is done most often to offer an alternative to patients with few or no treatment options available, such as those with HIV infections and rare diseases. These drugs receive approval through the EU's centralised procedure and Norway must comply, except for a few allowed exceptions.

Both of these regulations have presented a major challenge for the country's drug committees and other agencies to provide independent information on new drugs and for doctors to make rational prescribing choices.

(Norwegian Drug Bulletin)

Antibiotic plan put forward by WHO

The World Health Organization has announced a plan to halt antibiotic resistance. The three-part campaign, outlined in an article appearing in the journal Science, calls for improved rational use of antibiotics in humans, reducing their use in other fields and limiting the spread of resistant organisms through improved hospital hygiene and public health measures. In the journal, writer Rosamund J. Williams, a WHO infectious disease specialist, said "Twelve million antibiotics prescriptions to adults in the United States in 1992 were for upper respiratory tract infections and bronchitis, on which these drugs have little or no effect."

WHO calls for improving prescribing habits by educating both doctors and consumers. It says both need better access to objective drug information and disease-specific treatment guidelines. The organisation is also recommending a regulation that would end the profit motive from overprescribing. The writer argues that until other sources of income are identified to make up for profit losses resulting from fewer prescriptions, education and technical advances will not be able to change prescribing patterns.

(Reuters News Service on E-Drug)

Canadian firm tries to stop report

Pitting market share against freedom of speech, Bristol-Myers Squibb Canada, Inc. asked a judge to block publication of an independent research report about its best-selling anti-cholesterol drug. The drug, marketed as Pravachol, brings in revenues of approximately Can $ 400,000-500,000 (approximately US$ 266,666-333,333) every day. Concerned that the report's publication would decrease sales, the company argued that there was a difference of scientific opinion and asked a judge to stop publication. However, the judge ruled that the company could not show it would be damaged by the report's release and allowed publication.

(Globe & Mail, 12/6/98)

ISDB criticises EMEA information

Members of the International Society of Drug Bulletins (ISDB) presented the report "ISDB Assessment of Nine Public Assessment Reports Published by the European Medicines Evaluation Agency". It provided a critical assessment of information provided by the European Medicines Evaluation Agency (EMEA) when drugs are approved through the centralised procedure. The ISDB report was prepared for a joint workshop with the EMEA entitled "The EMEA Information Provision and Policy and the Needs of Independent Bulletins". The meeting was attended by approximately fifty people including members of HAI, ISDB, consumer organisations, medical journals, adverse drug reaction centres and national drug regulators and the Committee on Proprietary Medicinal Products (CPMP). (This last group is the scientific committee of the EMEA concerned with new drug assessments.) The meeting was held to review the quality and usefulness of information provided by the EMEA. ISDB found the information, given in the form of a European Public Assessment Report (EPAR), to be highly variable in quality. The group found inconsistencies between reports on what information was included. It also found instances where clinical trials were not included which raised questions of whether or not the EMEA carries out its own systematic review or simply relies on the information provided by pharmaceutical companies.

ISDB's study of nine, random EPARs showed that the information given often did not meet readers' needs as varying degrees of detail were given about trials, safety aspects were discussed to differing degrees (which could cause confusion about the benefit/risk ratio) and package leaflet information also varied in length and often was too brief about adverse effects. ISDB concluded "On the whole, the presentation of the EPARs could clearly be improved. The current lack of uniformity suggests they are not written at the EMEA with a common guide and editorial standards."

Rolf Bass, head of the EMEA's Unit for the Evaluation of Medicines for Human Use agreed that there is room and need to improve the EPARs. In the future, he said the EMEA will include a complete list of trials. This will allow groups such as ISDB at least to be able to identify which trials have been used when licensing a new drug. Also, the EMEA will soon produce a catalogue of all its documents including restricted ones, so that interested parties will at least know that a restricted document exists.

It became clear that member states are considering a public assessment report for products in the decentralised procedure. "What should be withheld, rather than what should be released" should be the starting point for this debate," one regulator commented at the meeting. It was suggested that the most transparent country set the agenda for the rest.

During the day's programme, the EMEA also discussed information provision related to pharmacovigilance, including crisis situations. The group debated the issues related to the need to balance early access to safety information while avoiding unnecessary alarm and possible bias in the review process.

For more information about ISDB's comments or the workshop, contact: Ellen 't Hoen, ISDB Coordinator, P.O. Box 459, 75527 Paris Cedex 11, France, tel: (+33-1) 4700 3320, fax: (+33-1) 4700 2864 or e-mail: isdb@compuserve.com

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