Public Citizen Health Research Group Publishes Companion to Worst Pills, Best Pills 1999 Edition

Since publication of the 1999 edition of our book Worst Pills, Best Pills, a large number of drugs have come on the market. Because of many requests for an update from people who have the 1999 edition, we are publishing the Companion, which must be used in conjunction with the older book because the drugs in the Companion listed as Do Not Use refer to safer alternatives that are discussed in the 1999 edition.

In 1997 and 1998, 91 new drugs—an unprecedented number for a two-year period—were approved for the first time by the Food and Drug Administration (FDA). Many of these drugs should never have been approved because of toxicity. The majority have no proven advantages over older, often much less expensive, drugs and, in fact, may be less safe and effective than already available drugs intended for the same uses. An increasing number of new drugs have been developed recently only to extend patent monopolies on lucrative products. These drugs cause economic harm to both consumers and the health care system. Unfortunately, there are still many older drugs on the market which should be taken off because of clear evidence of their dangers.

Twelve drugs, accounting for a total of 92.9 million prescriptions filled in 2001, are all listed as Do Not Use in the Companion. Many drugs reviewed in the new publication carry big price tags even though they have not been proven safer or more effective than existing drugs. Thus, by using the Companion you can not only reduce your risk of adverse drug reactions but you can also lower your drug bills. These Do Not Use drugs are:

Of the 66 drugs covered in the Companion, 63 are drugs that were not in the last edition of Worst Pills, Best Pills. Two drugs in the last edition, thioridazine (MELLARIL) and zafirlukast (ACCOLATE), have been downgraded to Do Not Use because of their toxicity. Of the 63 new drugs in the Companion, 45 (more than 70 percent) are listed as Do Not Use, either because of 1) clear dangers (30 drugs such as the 12 drugs listed above) which make them riskier than alternative, equally effective drugs or 2) they have not been on the market long enough to be used with confidence that they will not be banned or be the subject of black box warnings. This latter group of 15 drugs are all listed as Do Not Use until Seven Years after Release.

In previous editions of Worst Pills, Best Pills and in this newsletter we have recommended waiting for at least five years before using newly approved drugs which are not significant therapeutic advances over existing therapy. However, a study published in the May 1, 2002 Journal of the American Medical Association, by researchers at Harvard Medical School and Public Citizen has caused us to extend this warning to at least seven years (see the June 2002 issue of Worst Pills, Best Pills News). In this study we examined all drugs approved by the FDA from 1975 through 1999 and found that 56 drugs either had to be withdrawn from the market or were required to have a black box warning because of serious risks unrevealed or unknown at the time of approval. The estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was found to be 20 percent. Half of these problems are discovered within the first seven years after marketing, the other half between years 8 and 25. Damage to the liver, heart and bone marrow, as well as pregnancy risks, are the most common problems that arise after new drugs are introduced.

“This study will change the way I talk to patients about the use of new drugs,” said Dr. Karen Lasser, an author of the study and a primary care doctor and researcher at Cambridge Hospital and Harvard Medical School. “If there is a safer, effective drug that has been in use for a number of years, I would strongly recommend it over a newer drug whose safety profile is unknown.” Prescription drug adverse effects are a major public health problem. “Twenty million patients, almost 10 percent of the U.S. population, were exposed to the five drugs withdrawn from the market between September 1997 and September 1998,” said Dr. Paul Allen, study co-author, and internal medicine specialist at Cambridge Hospital and Harvard Medical School. “Yet the drug companies push the public and doctors to use new drugs that are more profitable but also more dangerous.”

What is going on between the FDA and the pharmaceutical industry that has caused this wave of dangerous drugs being approved? For the past 10 years, there has been a direct cash pipeline from the drug industry to the FDA, cloaked in the legal “respectability “ of a 1992 law, the Prescription Drug User Fees Act (PDUFA), which set a Faustian bargain into action. The drug industry pays the FDA directly for most of the cost of reviewing new drug applications and, not surprisingly, extracts deadlines and other strings attached to the money, which have created, among FDA physicians and other scientists, “a sweatshop environment.” This description is not ours but that of Dr. Janet Woodcock, the physician who directs the drug division of the FDA.

There has been a dangerously high rate of turnover among employees in this part of the FDA. Many of them have told us that their decisions against approving drugs because the drugs are too dangerous are all too often overturned at higher levels of the FDA and that they are being instructed not to present information at FDA advisory committee meetings which might “prejudice” the committee against recommending approval of the drug.

Compounding this problem has been the virtual absence of constructive Congressional oversight. In the past, when a drug should either not have been approved because of its dangers or should have been more promptly banned after its dangers became known, a House or Senate hearing would force the FDA to explain what went wrong and would extract some element of accountability from the Agency. These kinds of hearings have not happened for more than 15 years.

What You Can Do

Do not stop taking a drug without checking with your physician.

To reduce the chance that you or a family member will become a victim of preventable adverse drug reactions take our Do Not Use advice literally. In addition to not using the 45 drugs listed in the Companion and the 160 drugs listed in the 1999 edition of Worst Pills, Best Pills, keep up your subscription to Worst Pills, Best Pills News, which provides you with, in timely fashion, early warnings about newly discovered prescription drug dangers.

Below is a list of seven dangerous drugs all withdrawn from the market because of multiple injuries and deaths associated with their use. In some cases, we warned readers of Worst Pills, Best Pills News not to use these drugs years before they were withdrawn.

Assume that any new symptom you develop after starting a new drug may be caused by the drug. If you have a new symptom, report it to your doctor. This is crucial since many adverse drug reactions may mimic “normal” diseases or problems. In Worst Pills, Best Pills—1999 edition) we list the following:

• 148 drugs which can cause depression;
• 133 drugs which can cause hallucinations or psychoses;
• 128 drugs which can cause sexual dysfunction;
• 76 drugs which can cause dementia;
• 52 drugs which can cause falls and hip fractures;
• 22 drugs which can cause injurious auto accidents;
• 27 drugs which can cause insomnia;
• 105 drugs which can cause constipation;
• 36 drugs which can cause Parkinsonism.