It is one of the assumptions of daily life that the millions of prescription drugs taken by hundreds of thousands of us each day are safe and have been proven to be so.
A body of law, regulation and independent agencies have grown up to protect us in this area and have been able to instil public confidence in the medicines we take.
However, major changes are underway in the United States, where the Food and Drug Administration (FDA) has traditionally provided a first line of defence for consumers of medicines all over the world.
An FDA licence for a drug represents the ultimate seal of approval and facilitates its entry into the international market. However, it is happening with increasing frequency lately that major new medications have been running into problems with significantly harmful side effects.
Prominent recent examples include several types of anti-depressant drugs, a number of the Cox II-type arthritis drugs, such as Vioxx, and medications, like Baycol, for high cholesterol.
Which brings us to the second line of defence for the consumer or, in these cases, the patient. The courts in the US permit the filing of class-action suits, in which large numbers of people harmed in a particular way can bring whoever caused the damage to book.
Class-action suits taken against drug companies have been a critical means of ensuring the safety of medicines, and the accuracy of how they are described and prescribed. While the suits may be taken in the US, regulators around the world - including our own medicines board - sit up and take immediate notice of the outcome of such actions. Even the threat of an action has provided a powerful incentive to force drug companies to withdraw potentially dangerous drugs from the market.
Under Irish law, class actions are disallowed, although the Law Reform Commission has argued that there is a strong case for introducing legislation to permit them. So far, no such legislation has materialised, resulting in Irish consumers and patients remaining merely spectators in the large global battles currently taking place mainly in the US between the public and the giant pharmaceuticals.
The Bush administration has moved decisively to curtail the rights of US citizens to take court action against corporations in cases where people have been damaged. This move, somewhat ironically entitled the Class Action Fairness Act, was signed into law by the president last March. It has been welcomed by a delighted coalition of tobacco companies and pharmaceuticals. In addition to this, the FDA has dramatically reversed its drug-safety policy, and is now actively siding with drug companies and against consumer interests.
The FDA has begun encouraging pharmaceuticals to use what is known as the pre-emptive defence when they are sued. This allows the companies to argue that since their particular drug has been licensed by the FDA, the responsibility for safety is now that of the regulator rather than the pharmaceutical company's.
In this way, drug companies have been getting off the hook, and escaping scot-free as the courts have dismissed a number of recent cases against them.
The architect of this new policy is the FDA's chief counsel, Daniel Troy. He is a lawyer who used to advise the pharmaceutical industry and is a direct appointment of President Bush. He has told drug companies to "make it sound like a Hollywood pitch" when they now seek the willing assistance of the FDA to fight off patients harmed by their medications.
This move has been sharply criticised by Margaret Jane Porter, the former FDA chief counsel under Bill Clinton. She has argued that the FDA and the courts system "operate independently, each providing a significant, yet distinct, layer of consumer protection". With the FDA joining the pharmaceutical industry to defend legal cases, one of those critical protection layers for people all over the world is now being stripped away.
Put that together with the recent attempts by FDA management to discredit their own associate director of drug safety, Dr David Graham, when he attempted to draw attention to what he described as the "single greatest drug safety catastrophe in the history of the world" - the licensing by the FDA of the drug Vioxx to treat arthritis.
Graham pointed to the fact that the dangers of Vioxx were apparent for several years, during which time up to 139,000 Americans may have suffered heart attacks or strokes directly as a result of taking the drug. He told a US Senate hearing that the FDA is now "incapable of protecting America against another Vioxx".
And if America cannot be protected, where does that leave the rest of us? The Irish Medicines Board, and the European network of which it forms part, certainly provide us with an important level of protection. But developments in the US remain a critical factor in determining whether or not a drug is safe. And with the curtailing of class-action suits, which ultimately help to equalise the odds between huge corporations and the ordinary citizen, each and every one of us is the loser.
mraftery@irish-times.ie