[3 October 2012] - Unquestionably, medicine plays a huge role in securing children's rights. Indeed, the Convention on the Rights of the Child is clear that children have the rights to survival, development, and the highest attainable standard of health, all of which must be respected if they are to fully enjoy the wide range of rights under the Convention. Medical assistance is hence vital to the fulfilment of all children's rights, and prescription drugs are often an important component of health care.
But what happens when the very same companies that provide life-saving drugs violate some children's rights to improve health care for others, or simply to increase the bottom line? As the pharmaceutical industry becomes increasingly globalised, it is ever more important to ask this question. Over the past several years, lawsuits and investigations have cropped up around the world that raise concerns about not only testing drugs on children, but administering untested or unnecessary drugs on children. This editorial offers a review of these concerns.
Trials on trial
Testing drugs on children is fraught with ethical concerns, especially in countries in which the medicine in question will likely never reach the shelves. Nonetheless, drug companies continue to outsource trials to less developed countries where expenses are low and doctors and patients are more easily convinced or even pressured to participate. In some of the worst cases, trials have resulted in death and permanent disability. Some survivors and relatives have taken to the courtrooms, while others have called on their governments to crack down on companies and doctors who flout rules about drug testing and violate children's rights with impunity.
In the summer of 2011, for instance, pharmaceutical giant Pfizer began making payments to families of Nigerian children who died of meningitis following a controversial drug trial marred by allegations of lack of consent, inadequate documentation and medical malpractice. Compensation was slow to arrive, however, and Pfizer has since been threatened with a lawsuit demanding prompt payment for valid claims. At the same time, other advocates have begun to voice concerns about a DNA testing requirement imposed on claimants. Because many victims do not understand what DNA testing is and fear any further medical interaction with the drug company, some have opted to abandon their claims entirely.
By the same token, activists in India are outraged that doctors involved in secret drug trials on children and other patients with learning disabilities have been fined less than $100 each. The doctors, two of whom continue to deny any wrongdoing, are alleged to have been paid by drug companies to test drugs for sexual dysfunction and other problems on over 200 patients. The state government of Madhya Pradesh, where the trials took place, has confirmed that the tests were not authorised by health authorities and noted that participating doctors now refuse to provide further details on the grounds of doctor-patient confidentiality. Nonetheless, many fear that the government-issued fines are nominal and will do little to deter further illegal testing.
With a perhaps heavier hand in Argentina, British drug manufacturer GlaxoSmithKline has recently been fined $230,000 by a court after 14 babies died during a vaccine drug trial. The company has been criticised for its handling of the tests and choice to locate the trial in a largely impoverished community, with many parents alleging that they were not informed of their children's participation in a drug trial until after the vaccine had been administered.
Although it has not yet faced legal action, there are also reports that pharmaceutical company Bayer is carrying out “an ever increasing number of dangerous drug trials in poor countries, because they offer a large reservoir of test subjects, low prices, fast procedures and little supervision by the authorities.” India's low cost, high population, and lax government oversight have made the country a mecca for drug testing, and there are now almost 2,000 clinical studies being carried out on roughly 150,000 people across the country.
Sadly, as the number of trials rises, so does the number of fatalities, with the Indian Health Ministry reporting that more than 1,700 participants have died in the past 4 years, 138 in connection with Bayer. Experts caution that the actual number may be much higher, though, with most deaths not being reported as investigations and autopsies are not often conducted and relatives may not even know the deceased was involved in a drug trial. Compounding the situation, most study participants would have been illiterate and exceptionally poor, raising questions about informed consent and whether the risks of experimental medicine would have been adequately explained.
India is not alone, as Bayer has also carried out human trials in other countries with large disadvantaged populations including Colombia, Pakistan, Moldova, the Philippines and China. While not all of these have led to disastrous consequences, similar trials run on children in Poland by another company have left parents angry and disappointed when drugs that delivered significant improvement in their children's health were withdrawn at the end of the study. One mother worried not only about her son's future treatment, but questioned her decision to volunteer him for the trial in the first place: "I can't believe I signed my son up for this trial without really understanding what I was agreeing to. I was blind. I realize now that people taking part in clinical trials should have the right to ask questions and be spoken to like human beings, not just guinea pigs," she said.
On the other side of the issue, concerns also abound about the use of medicine that hasn't been tested on young subjects. In the United States, for instance, four out of every five children in hospitals are treated with drugs that have been approved only for use in adults, and one out of every three take similar drugs at home. While this is not illegal, it leaves doctors essentially guessing about safe, effective doses for children and inevitably risking serious, sometimes even permanent, consequences.
It has also been reported that legitimate drug trials conducted in children are few and far between, poorly administered, and focus on medications to treat adult ailments. With the serious ethical and legal concerns around testing in children, it seems many drug companies are not willing to take on the added hassle and expense to run these trials, and as it is, they already sell plenty of adult drugs for use in children. As a result, although children present the bulk of health concerns, only 12 per cent of clinical trials are pediatric, and medications needed by children in developing countries are the least likely to have been tested.
The spectre of negative consequences from inadequately tested drugs is far from new, with a class action lawsuit filed by children born with birth defects decades ago in Australia now being allowed to proceed against a German pharmaceutical company and a drug distributor. The company manufactured the morning sickness drug thalidomide, which was administered to pregnant women primarily in the 1950s and taken off the market in 1961 when it was linked to birth defects and discovered to have led to deformities in thousands of babies around the world. The lawyers behind the suit emphasise that the drug was never tested on pregnant animals, and that no attempts were made to explore what effects it had on the children of the women who had taken the drug once it was on the market.
Even medicine known to present serious risks to children's health may sometimes remain on the shelves. In the United States, two parents recently filed a lawsuit against pharmaceutical company Johnson & Johnson after contaminated pain killers allegedly resulted in the 2010 death of their infant son. Thirteen days after the child's death, the company issued the largest recall of children's medicine in history, and the parents point to a government report that reveals a long history of rampant health violations at the manufacturing facility responsible for the contaminated medicine. From 2008 to spring 2010, the federal Food and Drugs Administration apparently received 775 reports of health consequences resulting from Johnson & Johnson products, including 30 deaths. In 2009, rather than formally recall a distribution of defective drugs, the company's manufacturing facility in question is said to have secretly hired a third party to remove the drugs from the shelves to avoid negative press, spurring a government takeover of the plant and a criminal investigation of these “phantom recalls.”
Drugs for sale
Despite the failure to invest in sound, ethical research on paediatric medicines, children have pharmaceutical companies' attention. By some reports, they are “the new frontier for sales of prescription drugs,” and children's drug use has in some places grown faster than any other age group in recent years. In Uruguay, for example, the vast increase in prescriptions to treat attention deficit hyperactivity disorder even prompted a court to order that the Government tighten controls on a drug commonly used to treat it. In the United Kingdom, there are now similar calls for restraint given that prescriptions for the disorder quadrupled in the past decade and have been given to children as young as three. Read CRIN's editorial on children's rights and medication for attention deficit hyperactivity disorder here.
Concerns have also been raised in the US about drug companies' relationships with doctors and pediatric medicine. Last year, Florida ordered a sweeping investigation after finding that many psychiatrists engaged to treat children in the juvenile justice system had accepted large fees from manufacturers of antipsychotic medications. Child advocates have argued that the rising and widespread use of these powerful drugs, some of which are not even approved for use in children, is little more than a “chemical restraint” on children.
Raising similar worries, a study has found that poor children in the United States are significantly more likely to be prescribed antipsychotic drugs, often for less serious conditions. Among other factors, the expense of counselling sessions and difficulty poorer families may find to make regular therapy appointments make resorting to medication seem more appealing. "It's easier for patients, and it's easier for docs," notes one psychiatrist. "But the question is, 'What are you prescribing it for?' That's where it gets a little fuzzy."
In the developing world, meanwhile, it seems drug companies are looking to restrict access to medicines that are no longer protected by patents and hence do not hold the promise of great profits. Just last month, a judge in Kenya ordered the government to amend the country's 2008 Anti Counterfeit Act, a move the court hopes will alleviate the legislation's serious threat to Kenyans accessing affordable and essential drugs, including generic medicines used to treat HIV and AIDS. The court's decision has substantial support in India, where one quarter of the world's generic drugs are manufactured. India has challenged anti-counterfeit legislation across East Africa, maintaining that large, multinational drug companies are behind the drive to curtail importation of inexpensive, life-saving medicine by equating generic drugs with counterfeit drugs.
Back to rights
While pharmaceutical companies have the power to greatly increase children's well-being, it is difficult to see how this can be accomplished by conducting unsafe and unregulated trials, prescribing untested medicine as a matter of course, and lobbying to give some children medication they don't need while seeking to deny others the medication they do need. These practices threaten rather than enhance children's rights to survival, development and health, and CRIN firmly believes that they must be put to an end. As the business of medicine expands around the world, its focus must be fundamentally revisited and revised in light of global ethical concerns and, above all else, the pharmaceutical industry should realign its focus to ensure that its efforts are in the best interests of all children.