Politics & Policy

One Step At a Time

Progress in pharmaceuticals happens slowly.

The pharmaceutical company Merck’s recent withdrawal of Vioxx, a popular pain and anti-inflammatory medication, has intensified the debate about what critics claim is the predominance of “me too” drugs among newly approved pharmaceuticals.

#ad#Whereas the people who bring the public new prescription drugs were once hailed for their life-saving achievements, they are now bashed and admonished, just like “big tobacco.” One of the critics’ complaints is that “big pharma”–a term out of the trial lawyers’ handbook on how to frame the issue–is not producing enough important new drugs, and that too many of the drugs that are being produced are not significant improvements over drugs already out there. According to critics, these so-called me-too drugs are aggressively promoted and raise the costs for consumers and the public health-care system. Some think that the case of Vioxx buttresses their arguments.

There are several problems with this line of thought, however. Critics are often vague about what constitutes a me-too drug. Even prescription drugs that address similar symptoms and diseases are not the copycats they are sometimes portrayed as being. There is an army of vigilant intellectual-property attorneys from competing companies out there ensuring that there are no infringements on their companies’ patents.

The Food and Drug Administration (FDA) does require pharmaceutical companies to prove the safety and effectiveness of drugs before their approval. A real me-too product would be similar or identical to an established product with no significant advantage over it.

Pharmaceutical drugs approved in the last year by the FDA address problems ranging from Parkinson’s disease, colorectal cancer, HIV-related symptoms, depression, Glaucoma, high cholesterol, and more. Although these new drugs might often be based on existing drugs, the producers must prove that they differ from existing patented drugs and that they work as claimed by the company applying for approval.

While many new drugs may not provide groundbreaking improvements, they may nevertheless be beneficial for consumers. In the case of Vioxx, the FDA approved the drug partly because studies showed fewer side effects of stomach ulcers and bleeding in patients. Merck’s follow-up studies have now revealed that long-term use of the drug can significantly increase the risk of heart attacks and strokes. The company decided to withdraw the drug from the market because of their new findings and because alternative medication is available for consumers in need of pain medication for the targeted ailments.

More often than not, drugs that improve upon an older model provide significant benefits. Their improvements may involve reducing side-effects such as nausea, drowsiness, dizziness, bleeding, numbness of extremities, and blurred vision; providing time-release formulas, especially important for children, the elderly, and the severely ill; reducing negative interactions with other drugs; providing choices in the form of dosage, such as pill, capsule, liquid, which improves ease of usage for many patients; and increasing the potency of a drug.

Almost everyone has experienced the slightly different effects that even common drugs have on different people. Patients and their doctors sometimes have to test several remedies before they find the best drugs for them. Relatively small side effects, such as tiredness, upset stomach, or dizziness can be very disruptive for a patient’s daily life, especially when long-term medication is required for a chronic condition. Even improvements in delivery systems for the medication can mean real advantages for a patient’s quality of life. For example, patches releasing painkillers on a more consistent basis have been significant advances for cancer and other patients dealing with severe pain.

In addition to the health or usage benefits of many follow-on drugs, consumers can benefit from greater competition in the market place. While companies might demand a premium for a new drug, companies already in the market might offer a lower price to defend their market share, especially when the patents for the established drugs expire and other manufacturers start producing generic copies. Consumers in the U.S. often have access to generics that provide significant discounts. Generic drugs now account for roughly half of the U.S. pharmaceutical-drug prescriptions filled. Prices for established pharmaceuticals may also drop significantly with the increased competition from generics. While some consumers might be reluctant to switch from their established medication to a generic drug, the market for generic pharmaceuticals has steadily risen in the last few years, and consumers are becoming more aware of their options.

Quantum leaps and breakthroughs are unfortunately rare in every field of research, including medical research. Research and discovery works through an often painfully slow step-by-step extension of existing human knowledge. Innovation is usually an evolutionary process, in which incremental changes are made, and subsequent researchers build on those changes. Decades can pass between the small discoveries during basic research that finally end up in a breakthrough drug, while many more research leads have to be abandoned because they cannot be turned into beneficial drugs or procedures. Creating a research environment that consistently produces breakthrough drugs is one of the more challenging management problems. Setting the correct public-policy incentives can help encourage such creativity, but it is no sure thing. But even the smaller, incremental improvements of the disparaged me-too drugs can bring real benefits for consumers in their daily lives.

Barbara Rippel is a policy analyst at Consumer Alert.

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