Campaigns

Secrecy in the Canadian drug regulatory system: Does industry run the show?

The Health Protection Branch (HPB), Canada’s drug regulatory agency, is severely jeopardised by a complete lack of transparency in the way it operates, a recently published study asserts.

Secrecy has always been a part of the HPB, but new efforts to privatise and downsize have seriously compromised its work and resulted in unsafe drugs reaching and remaining in the Canadian market, charges an article in the International Journal of Health Services written by HAI member Joel Lexchin. The weakening of regulations controlling the promotion of pharmaceuticals to consumers will likely lead to irrational drug use and also threatens the ability of the HPB to set priorities for the country’s drug regulation system, the author suggests.

In 1992, the Canadian health ministry commissioned an inquiry into the drug approval system. The 152 recommendations that formed part of the subsequent report failed to make any mention of transparency. Although the current Director General of the Therapeutic Products Programme has made a move to address access to information no new information has been released. At present, health professionals and consumers have no access to information regarding products under review by the HPB. All stages of approval for new drugs are confidential. Information continues to be withheld even after a new drug has been approved for marketing. Information about a particular drug is only released once a clinical study has been made public and the manufacturer agrees to its release. Unlike the US Food and Drug Administration (FDA) which issues a “Disclosable Summary” outlining why the drug was approved and providing information about the safety and efficacy of the drug, the HPB only provides information in the product monograph. Here the information is often based on unpublished or inaccessible studies and verification is impossible.

Severe HPB funding cuts have resulted in the introduction of ‘user fees’. Pharmaceutical companies now pay an annual fee for each drug they market and an additional fee to have a new drug evaluated. In 1997-1998, 70% of the CAN$ 49 million (approximately US$33 million) of HPB revenue was contributed by the industry and the industry is now demanding changes in the approval system including eliminating the backlog of drugs awaiting approval. (International Journal of Health Services, Volume 29, Number 1 –1999).

The future funding of drug regulatory agencies

A disturbing new trend can be seen in the world of medicines regulatory agencies. It has become increasingly popular for countries to set up profit-oriented agencies responsible for licensing new drugs and carrying out postmarketing surveillance. Traditionally these tasks have been roles of national health ministries. In Europe this role has been partially taken on by the European Medicines Evaluation Agency (EMEA).

The fundamental difference between the ministries of health and the new agencies is that the former received a budget from the government while the latter manage their own expenditures and funding primarily with drug manufacturers’ registration fees as a source. The new agencies are essentially public bodies under state control however they are also autonomous.

The French independent drug bulletin, La revue Prescrire, examined the annual reports of three such agencies: the French Agency for Health Product Safety, the EMEA and the US Food and Drug Administration (FDA). In all three agencies drugs manufacturers’ fees form a large part of the budget. In 1998, it formed 40% of the FDA budget. In the same year, manufacturers’ fees were 68% of the French agency budget and in the EMEA annual budget, drug companies’ fees represented an impressive 53% of the funding. In fact, the EMEA has predicted that by the end of this year industry money will account for 69% of their funding.

Prescrire suggests that the situation clearly implies a conflict of interest. The journal asks: To what extent is it logical that these agencies with a clear public health mission be funded by rich and powerful pharmaceutical companies? The pressure to release new drugs as quickly as possible will certainly grow for these “independent” agencies.

(La Revue Prescrire in the ISDB Newsletter Vol. 13, No 2, December 1999)

Canadian coalition highlights policy’s effect on women’s health

A group of consumer organisations, academics and women’s health activists has been working since 1998 in Canada to improve the national health protection system and raise awareness about the health policy’s potential impact on women’s health.

The Working Group on Women and Health Protection has drawn attention to some alarming facts including: the Can$100 million (approximately US$67 million) budget slash in the health department’s health protection branch since 1994; the closing of several labs that tested drugs and food for toxicity; and the fact that about 70% of the branch’s running costs are financed by drug industry user fees. The coalition points out that these facts are all particularly worrisome for women as the decision-makers on health care in most families. Moreover, in the past 50 years a number of popular drugs approved to treat women were later found to harm their health including early versions of the contraceptive pill, the Dalkon Shield and Copper 7 IUDs, DES, thalidomide and most recently the Même breast implant.

The group is financed by the Centres of Excellence for Women’s Health Program, Health Canada and works under the auspices of DES Action Canada. For more information about the group’s activities, visit http://www.web.net/~desact.

IMF – World Bank Protests

Government spending on developing countries and public health issues affecting the poor are generally not a major focus of the mainstream media. The April 16^th protests in Washington D.C. against the policies of the International Monetary Fund (IMF) and the World Bank however, resulted in more mainstream media coverage than they have received in the past twenty years.

The April 16^th protests form part of the wake up call to the US public about corporate globalisation. For many years now, people in developing countries have protested against the tough structural adjustment policies of the IMF and World Bank, which tend to have the worst effect on the poor, often intensifying economic inequality.

The protests, attended by tens of thousands of people, denounced the structural adjustment policies (SAPs) imposed upon developing countries by the Fund and the Bank. Members of the US public have become increasingly concerned with the fact that both organisations are unaccountable to the people in developing countries to whom they provide aid. However, they are quick to respond to the United States, the largest shareholder in both institutions.

Perhaps one of the biggest surprises of the day was the fact that the protests were endorsed by US organised labour. A number of major unions supported the rally. Members of the G-77, a group of most of the world’s developing nations, also endorsed the Washington protests and openly condemned SAPs. Arthur Mbanefo, Nigerian spokesperson for the G-77, voiced his disapproval of the institutions’ policy initiatives citing privatisation, a refusal to cancel debts and a blueprint for the structural adjustment agenda. In response, spokespeople for the IMF and World Bank emphasised that focus is increasingly being placed on poverty and empowering the poor. At the same time, the organisations have no plan to abandon their policy on SAPs.

(Focus on the Corporation, 19 April 2000)

Coalition pushes for global register for clinical trials

Most clinical trials only become public knowledge when and if the investigators publish an article about its findings in a medical journal. In fact, often only a handful of people (investigators, funders and government regulatory bodies) know about ongoing clinical trials from their start.  Randomised trials of medical interventions are the basis of evidence-based health care. If trial designs and findings are not brought into the public domain the risk increases of duplicating trials and ignoring early warning signs that an intervention is dangerous. A group of interested parties involved in clinical trials is now promoting a register of all clinical trials in an effort to prevent these problems and create greater transparency.

A recent conference held in London and hosted by the British Medical Journal, The Lancet and the Association of the British Pharmaceutical Industry discussed the possibilities of such a trial register. The register would make public basic information about clinical trials. Thus, health providers, researchers, the public and funding bodies would have reliable information available to them from the onset of any research. A trial register would prevent duplication of effort, increase collaboration, and save lives. By making the process legally compulsory, it would ensure the registration of every new research study. Moreover, researchers would be alerted to gaps in the knowledge base, so their choice of research topic would be more transparent thus increasing the credibility of research performed by the pharmaceutical industry.

Although no consensus has yet been reached on the type of information to be included, most agree that it should include the title and research questions as well as the study population, intervention, institution, funding organisation, status, methodology, ethical aspects, results and a full protocol. To date, many researchers, funding agencies, patient groups, governments, and two leading pharmaceutical companies (Glaxo Wellcome and Schering UK) have agreed that clinical trials should be registered.

Currently, there are hundreds of trial registries worldwide. However they use different formats and not all are accessible to the public or even to researchers. Many of the registers in existence are limited to AIDS or cancer trials and most cover only drug trials leaving out all other interventions.

Some social aspects could interfere with a worldwide register. Cultural differences between profit-oriented and public research organisations, a lack of incentives to register research, competition among organisations already running a register, and questions of ownership and copyright all serve to hinder a unified register. Furthermore, drug companies have often fought against releasing information about new drugs.

(BMJ 1999;319:1565-1568, 11 December and http://www.bmj.com/cgi/content/full/319/7224/1565)

Active or abnormal? - US focuses on irrational use of calming drugs for children

When are active children too active? The blurry line between healthy energy and inappropriate activity is now being examined by the US government because of the skyrocketing number of prescriptions being used to treat hyperactivity.

The President reports that the number of pre-schoolers on antidepressants in the country increased more than 200% between 1991 and 1995. He announced that US$5million will be put towards new research on attention deficit hyperactivity disorder (ADHD) in this age group.

Three psychotropic drugs, methylphenidate (Ritalin), fluoxetine (Prozac) and clonidine (Catapres) have been the focus of a US initiative aiming to ensure that young children with emotional and behavioural problems are treated appropriately.

This initiative follows an article published in the Journal of the American Medical Association (JAMA) earlier this year that found that the use of psychotropic drugs, especially methylphenidate (Ritalin) had increased almost three times in children ages 2-4 years. Ritalin, which is prescribed for ADHD in pre-pubescent children, carries a warning that it should not be used on children under six years old. The JAMA study shows that 1%-1.5% of pre-school children aged 2 – 4 in the US receive stimulant, antidepressant or antipsychotic medications. The vast majority of these prescriptions are thought to be off-label.

In 1994, 3,000 Prozac prescriptions were written for children under one year old. Prozac is often prescribed for bed-wetting in the 5-13 year age group but has not been proved effective for under-ones. It is however, approved for use in patients 18 years and older who suffer from depression and obsessive compulsive disorders such as bulimia.

The use of clonidine (Catapres), which is indicated in the US for the treatment of hypertension, increased 28 fold between 1991 and 1995 in ADHD children below the age of 5. Clonidine is often prescribed to induce sleep in children with ADHD. The drug has not been approved for this use and induces undesirable side effects such as rapid and irregular heartbeat and fainting.  The United Nations narcotics control agency, the INCB also voiced its concern over the abuse of psychotropics for ADHD.

The White House intends to inform parents and teachers about the risks of these drugs, the FDA will develop new labels and the National Institute on Mental Health will begin a nation-wide study of Ritalin use in children under the age of 6. As Dr Steven E. Hyman, director of the NIHM pointed out “As a rule of thumb, doctors, psychologists and social workers should attempt to modify the behaviour of a child and deal with family crises before drugs are prescribed.”

 (Scrip, No 2520 8 March 2000, Scrip No 2525 24 March 2000 and The New York Times (web version) 20 March 2000)

WHO reports on results with donations guidelines

Out of 450 questionnaires sent, 172 questionnaires were returned and of 138 responses  analysed 42 were donors, 17 were consolidators and 79 were recipients. The survey found that the Guidelines had been adopted by governments or organisations involved with donations in 45 countries. The total value of donations reported by donors was US$298 million of which 76% was from industry donors, 23% was from NGOs and 1% was contributed by government agencies. Less than 20% of the reported donations went to aid acute emergencies.

From the survey, WHO found that 84% of donors, 92% of consolidators and a mere 35% of recipients reported that over half of their donations were based on specific requests. Respondents felt that the Guidelines were an excellent framework for improving drug donation practice and were helpful for preventing inappropriate donations. In total, 45% of recipients believed that the Guidelines resulted in donations meeting needs and resulted in improvements in shelf life. Consolidators appeared more troubled than donors or recipients with hampered, delayed or cancelled drug donations, probably related to the 12-month shelf-life requirement of some recipient governments. More information about the survey and the guidelines is available on the WHO website of the Department of Essential Drugs and Medicines Policy (http://www.who.int/medicines/).

Despite the fact that the World Health Organization’s (WHO’s) revised interagency Guidelines for Drug Donations have been in effect for more than a year now, critics say many US pharmaceutical companies still do not comply with the guidelines. Scott Hillstrom, President of Cry for the World Foundation, has made an effort to publicise  the underlying economic reasons. Simply stated, the US tax system creates incentives for donors and the NGOs that receive drugs and then donate them.

According to the US tax code, donors of “goods-in-kind” may deduct the cost of producing the drug, 50% of the difference between that cost and the wholesale drug price (but not more than twice the basic cost of the drugs/goods donated) from their taxable income. In other words, donors who need to be rid of drugs (because they are close to expiry or because there is no market for them) can donate the drugs, receive a good tax deduction and at the same time save themselves the high cost of destroying them.

While some drug donations are helpful, many are inappropriate and unhelpful. Developing countries who receive “unwanted” drugs face several risks. People may be treated with inappropriate drugs, foreign-language labelling can result in misuse,  high duties and taxes may need to be paid on these imports, some ‘dumped’ drugs may find their way back to patients via the black market, and scarce resources can be wasted destroying worthless drugs.

One reason perhaps, that the Guidelines are not followed by US manufacturers and donors is the risk of a large economic loss, a risk not incurred by multi-lateral and national governments who do not fall under US tax law. Some charities in fact, make their livelihood from accepting donations and sending them on. It would not be in their economic interest to reject donations that may be inappropriate, outdated or labelled in a language not suited for the end-user. As such, similar to donors, recipient charities have large incentives to accept whatever drugs the donor seeks to give.

Hillstrom puts forward a solution. As the current law is driven by tax benefits to donors, the rules need to be adjusted to ensure that donors have evidence that their drug donations were   

·       appropriately used,
·       properly labelled so that local practitioners could read them
·       not close to expiry date
·       compliant with the WHO drug donation guidelines.

In order to be entitled to tax deductions, donors would have to comply with reasonable market values rather than wholesale list prices and would have to provide documentation about each gift made to tax-exempt organisations. Such changes, he suggests, will force collecting organisations to accept only appropriate donations. 

For more information contact scott.hillstrom@analyticorp.co.nz

(WHO Revised Guidelines on Drug Donations 2000 and correpondence from S. Hillstrom)

The drug donations website now includes a checklist to help prepare donations before they are sent or to evaluate a donation once it has been completed. Although the checklist is geared towards donor organisations, recipients should also be encouraged to use the list to give feedback on donors’ practices in order to improve overall donation standards. To view the check list, click here.

A printed version available in various languages should be available shortly on the site.