Where are the Facts about the Drugs You’re Taking?

By: Kate Ryan

Picture a United States Senate hearing room (if you’ve never seen one, picture a courtroom). In a large room with a high ceiling, a row of United States Senators sit behind desks on a raised wooden dais; facing the dais is a table with a microphone for the people who will testify. A wooden divider separates this from the public seats. At a January 1970 hearing of the U.S. Senate Select Committee on Small Business, the observers in the public seats include a group of young women who came to Capitol Hill to hear about the safety risks of the first high-dose oral contraceptives.

The TV cameras start rolling as Senator Gaylord Nelson (D-WI), Chairman of the Select Committee, calls the hearing to order. Expert after expert – every one of them male – testify about the Pill’s dangerous side effects, including blood clots, heart disease, and cancer. But, not a single witness is a woman taking the Pill who can testify about her personal experience. The young women in the audience, including Alice Wolfson, are alarmed and angered by this omission. They raise their hands to ask questions but are ignored by the Senators. After one witness testifies that, “Estrogen is to cancer what fertilizer is to wheat”, Alice and the others can remain silent no longer. The TV cameras turn to them as the women jump up and shout out to the full hearing room: “Why are you using women as guinea pigs?…Why are you letting the drug companies murder us for their profit and convenience?”

Public interruption is very unusual during Senate hearings, and Senator Nelson told the women to sit down and be quiet. Fortunately they refused, shouting, “We are not going to sit quietly! We don't think the hearings are more important than our lives!” These hearings (known as the “Nelson Pill hearings”) were a pivotal event in women’s health advocacy — and Network history, as Alice Wolfson later co-founded the Network, with its unyielding commitment to ensuring women have accurate and balanced information about the drugs they take.¹
 
These hearings and continued advocacy on the part of women’s health activists resulted in the first requirement that prescription medications include a pamphlet, the patient package insert (PPI), disclosing the risks and side effects of the drug. While the PPI was an historic step forward, it has many failings: it is only required to be provided with estrogen-containing prescription medications; the drug manufacturer writes it; and there is no standardization of content or format. Consequently, the PPI does not meet patient needs.

Most of you have probably seen the Pill’s PPI: the small folded document that expands to a tablecloth-sized piece of tissue paper. The intent is to provide women with the information necessary to understand what they can expect from these drugs. But, the current PPI does not meet this goal; as anyone who has tried to read the Pill’s PPI knows, the documents are difficult to understand. The Network believes that medication information must be better!

As the number of prescription drugs has increased (there are currently approximately 22,000 on the market), the Food and Drug Administration (FDA) has tried to address the lack of uniform medication information with various proposals and initiatives to develop a standardized document detailing a drugs’ risks, benefits, side effects, and instructions for use. While it may seem like a common sense issue, there are many groups with different priorities involved in the development process. Drug companies are concerned about who will be responsible for writing the information; pharmacists are worried about who will be responsible for printing and distributing the document; consumer advocates are worried about the possible promotion of unproven uses, as well as an emphasis of benefits over risks. These conflicting demands have stalled previous efforts to develop standardized medication information.

In an effort to fulfill its mission to protect the public health, the FDA has once again taken up the challenge to improve medication information. In September 2010, the FDA held a hearing to obtain input from consumer advocates, patient groups, pharmacists, the drug industry, and others on the creation of a standardized, 1-page document for all prescription drugs, to be called Patient Medication Information (PMI). The FDA is proposing that a PMI insert would be required to be included with every drug, and each PMI insert would look the same — a concept similar to nutrition labels on food packages. All the risk, benefit, side effects, and instructions would be in the same place on each sheet and be phrased in a similar manner.

The Network was present for both days of the hearing, testified in support of uniform PMI, and made recommendations for how PMI can best protect women’s health. We urged the FDA to review and approve the content and format of all PMI inserts to ensure they are accurate and easy to understand and help consumers make informed decisions about their health. This information is particularly important when a drug has serious side effects or its effectiveness is contingent on following specific instructions (like oral contraceptives, which quickly become less effective if they are not taken at the same time daily). We recommended the FDA take a strong hand in the development and surveillance of PMI inserts. We believe that, if the industry is allowed to write PMI inserts without oversight, the information provided will be marred by the same flaws, distortions, and biases that affect so many marketing materials aimed at consumers today.

Referencing the Pill’s PPI, the Network pointed out that more is not always better. People who receive too much information have more trouble understanding and remembering what they’ve read.²  Thus, the PPI’s amount of information and the format make it less likely that consumers can understand the facts about the drugs they take. Without that understanding, consumers are exposed to potentially dangerous and unnecessary medical risk.

As consumers, we rely on the FDA to ensure that prescription drugs are safe and effective, and that we have all of the information necessary to understand what to expect from the drugs we take. As is the case with many consumer protection policies, however, this one will need support from consumer advocates to move forward. We hope that the FDA, with the help of the Network, will succeed in ensuring that every drug has a clear and concise PMI insert in the near future.

References:

1.  “The American Experience: The Pill,” Public Broadcasting Service (PBS), 2003. Online at: http://www.pbs.org/wgbh/amex/pill/filmmore/index.html
2.  Day, Ruth S, “Comprehension of Prescription Drug Information: Overview of A Research Program,” Paper presented at a symposium of the Association for the Advancement of Artificial Intelligence, 2006.