Panic Over Pills : Overreaction?

During the ten-year period between 1994 and 2004, the FDA approved 321 completely new drugs (this doesn't include approvals for changes to existing medicines), bringing the total to more than 10,000 drug products on the market. During that same period, eight drugs were withdrawn for safety reasons, such as the diet drug fenfluramine (fen-phen, associated with heart-valve disease) and the allergy drug Seldane (linked to heart arrhythmias). But the Vioxx recall created a shock wave like no other. Many people had come to depend on their medications, and they expected them to be safe, too, especially when they cost so much. Prescription drugs account for, some say, the fastest growing segment (about one-tenth) of all health expenditures, with some specialty drugs costing hundreds of dollars per dose.

"With Vioxx, the real shock and outrage came when there was a suggestion that people in authority may have known about these harmful side effects and not shared them with doctors or the public," says Anne Woodbury, chief health advocate for the Centre for Health Transformation, a think tank founded by Newt Gingrich. It made people queStion their faith in the pharmaceutical industry, regulators and physicians: those we trust to make sure our drugs are safe. Before, taking a newly prescribed pill with a slug of water was as routine as brushing your teeth. For many people, this is no longer the case.

"Now patients and doctors are going to ask themselves: Could this new drug be another Vioxx?" says Dr Jerry Avorn, a professor of medicine at Harvard Medical School and the author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs. People have reason to worry.

In clinical trial data submitted to the FDA, Vioxx showed no connection to heart problems. The drug was approved in May 1999. But after Vioxx hit the market, heart problems were revealed - lots of them. Tens of thousands of people may have been affected, and Merck was accused of hiding that information.

"The system is not perfect," comments Dr Marianne J. Legato, professor of clinical medicine at Columbia University College of Physicians and Surgeons in New York City. "Sometimes a company may not want to show data that are negative till they really know what's going on. But it's ridiculous to suggest that they would suppress things willy-nilly because if a drug is going to cause severe side effects, it's not in their best interest to hide that."

Legato, who has a busy practice in internal medicine, continues, All this hysteria is ridiculous. We're putting the pharmaceutical industry under a microscope in a completely inappropriate way.

Americans have somehow come to believe they should get the best medical care with the latest remedies with no side effects. Well, guess what? There is no drug that doesn't have side effects:'

Other experts say it's time for a major reality check. "With all due respect, I think the press has made this into a firestorm," says Peter Corr, head of worldwide research and development for drug manufacturer Pfizer. 'As a society we expect medicine to be perfect: There is no such thing. There is always a risk."

Even when a side effect is suspected, it can be very difficult to prove that it was directly caused by the drug. "With some kinds of adverse reactions, like liver toxicity, it's fairly obvious that it's related to the drug," says Dr Robert Temple, director of the office of medical policy at the FDAs Centre for Drug Evaluation and Research. "But it's much more difficult to link a heart attack or a stroke, because these are very common in the population. If someone has a heart attack, what would even make you imagine that the drug did it?"

There are so many variables, any one of which could cause an adverse reaction to a drug, from taking an in-correct dose to combining the drug with other medicines.

A growing cause of concern is the trend towards self-medication with untested over the counter supplements. If, for instance, a patient is taking a herbal remedy and also takes a painkiller or an anti-depressant, what will the combined effect be?

Despite the risks, there's no need to panic about prescriptions, says Temple. "Of drugs that are approved, one or two per cent may be withdrawn eventually. It's rare." And if you have enough information to weigh the risks and benefits, you and your doctor can make an informed decision.

How Side Effects Emerge

How can dangerous side effects take years, or even decades, to become known? A new drug is first tested on animals. If the results indicate that it's likely to be both safe and effective, the company applies to the FDA for permission to begin testing it in humans. Human studies have three phases: to evaluate safety, to determine effectiveness, and to verify safety, dosage and effectiveness. Although a trial may extend as long as five years and often includes between 3000 and 10,000 people, each partici-pant may only receive the medication for a period of weeks or months. Statistically, rare and dangerous side effects may not emerge until millions of people have used the drug, after official approval.

So why don't we test drugs on more people and for longer periods of time? For one thing, quicker approvals may save lives, as with drugs for AIDS or a vaccine for a newly emerging flu pandemic. Another reason is cost. "It already costs a billion dollars to get a drug from an idea to the market," says Corr. "If we had to study a million patients before we took a drug to market, there would never be another drug."

Monitoring After Approval

After a drug is approved, it is subject to post-market surveillance. The FDA analyses reports of "adverse events," or drug side effects, which come from the industry, from ongoing clinical trials and through its MedWatch programme, to which consumers, physicians, pharmacists and other health professionals voluntarily report problems.

Negative reports about a drug that's on the market can yield crucial new information. "Clinical trials that are negative are, many times, just as important as the trials that show positive results," says Dr Marvin Lipman, chief medical adviser for Consumer Reports. Legislation was introduced in the US in October 2004 to establish a registry of all clinical trials and their results (clinicaltrials.gov).

"We are the most regulated industry in the world," says Corr.'And frankly, that's how it should be. If there is a problem with a drug, we want to know about it sooner rather than later."

Consumers may know sooner too. In February the FDA announced the creation of an independent Drug Safety Oversight Board to provide expanded and faster drug-safety information to doctors and patients. While there will always be risks, the public may be better equipped to judge and act on them.

"We still need to be willing to take personal responsibility for assessing the risk-benefit ratio of a medication," says Legato. "Yes, you have to be completely informed to do it. And, yes, it's complex. But if we don't do this, it's like going back to the Middle Ages when there were no risks, except of dying by the age of 26. We have nearly doubled life expectancy since the beginning of the 20th century. That did not happen by accident. Prescription drugs have played a huge role."

How You Can Make Informed Decisions

Since there is no such thing as a pill that is completely safe, including aspirin, consumers have to accept the dichotomy that the same medicines that extend and enhance our lives may hurt us; some of them may merely have minor side effects, while others can be lethal. So how should you and your doctor proceed?

1. Weigh the risks and benefits of any drug.

As a smart consumer you must decide whether a drug is "safe enough" for you. The greater the benefit, the more risk you may be willing to take. If your illness is mild and not very bothersome, you may decide that any risk is too big and opt against taking any medication at all. Conversely, if your illness is serious or potentially life threatening, you may even be willing to try an experimental drug with greater risk for serious side effects.

2. Be especially cautious about new drugs.

New drugs are inherently risky. So if you're taking one, monitor yourself carefully. Have your eating and digestive habits changed? Are you feeling unusually tired or conversely agitated? Have your breathing patterns or skin colour changed? If so, call your doctor immediately, who may tell you to stop taking the drug.

How does a consumer know that a drug is new? Ask your doctor or pharmacist.

If you have a choice between two or more equally effective drugs, choose the one with a longer track record of safety. If you are taking a drug in the same class as one that has been recalled, it is prudent to ask your doctor if that drug places you at greater risk.

3. Know if you're in a high-risk group.

Although scientists still don't know precisely why, certain individuals have bad reactions to a drug or to a particular dose of a drug, while others don't. Men metabolise drugs differently than women do, for example.

Be especially vigilant if you are very young, very old or pregnant. Drugs usually aren't tested on these groups. "I worry the most about the elderly," says Avorn. "They are vastly under-represented in trials of drugs, yet they are the most likely to be taking the drugs when they are approved."

4. Ask the right questions.

When you get a new prescription, never leave the doctor's surgery without a clear understanding of why you're taking the drug, how to take it, and how you'll know if it's working. Even if it makes you a bit uncomfortable, ask.

You are responsible for your own health and safety. "If the doctor doesn't want to answer questions, you should probably find another doctor," says Avorn.

After your visit, if you still have questions, call or e-mail the doctor. Use your pharmacist as an expert con-sultant for any additional concerns you have about the drug or its side effects.

You can ask the pharmacist for the professional package insert, or PPI, for the drug, says Corr. Although it's written for health care providers, it includes information on clinical trials and side effects.

Also, if there's been a label change, with new information about the drug or any warnings, it will be part of the PPI.

Or request more consumer-friendly information, which should tell you how to use the drug properly and warn of any precautions.

5. Be informed, and follow directions carefully.

Check to make sure that the pills you receive are the cor-rect ones. Errors crop up in the dispensing of medications:

It's easy to confuse products with similar names (for example, Zantac and Xanax).

Read the instructions and take your pills exactly as prescribed. Be alert for expiration dates, and stay attentive to recalls and warnings. Tell your doc-tor about any other medications you take, either prescribed or OTC. Drug interactions can cause serious prob-lems.

For example, Posicor, an antihypertensive drug, was taken off the market because it could cause blood pressure to drop precipitously when used with other heart medications.

If you fill all your prescriptions at the same store, the pharmacist may be able to warn you of known interactions.

It is vitally important that patients and their doctors provide feedback to manufacturers and regulators if they have any suspicion of a problem.

Then these signals will be known and can be analysed to see if they are more wide-spread, which could save lives.

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