Periodic Reporting for period 1 - WITHDRAWAL AFTERMATH (The Aftermath of a Drug Withdrawal: Modeling Spillover Effects Across Countries and Across Categories)
Berichtszeitraum: 2015-09-01 bis 2017-08-31
Drug withdrawals show the flip side of pharmaceutical marketing. The growing pharmaceutical market increases the pressure for the regulators to approve new medicines and for firms the pressure to market their drugs to stay ahead of the competition. These forces contribute to the fact that some drugs were approved too early, and had to be withdrawn. In the years 2000-2010, there have been almost twice as many major withdrawals, compared to the decade before (respectively 28 and 15 withdrawals). On top of that, the pharmaceutical market has a sensitive nature, as it concerns the health of people. Together this gives pharmaceutical marketing a negative image. These aspects can give drug withdrawals disastrous consequences. The consequences are obvious for the focal drug, as sales drop to zero and the withdrawal often leads to a series of lawsuits.
However, it is unlikely that the effect of a withdrawal stops at the focal drug, as there are likely to be spillover effects to competing drugs in the same category, and to drugs of the same manufacturer. These spillover effects can be positive (e.g. additional sales from the withdrawn drug) or negative (e.g. less sales due to a negative image of the drug category or firm). There are some studies looking into the aftermath of a withdrawal from the perspective of the focal drug, but little research has been done on the spillover effects. In this project, I focused on these spillover effects. For example, a withdrawal (e.g. the statin Cerivastatin) in drug category A (i.e. statins) by firm X (i.e. Bayer) can have a spillover effect on the prescription behavior of doctors of other drugs in the same category (e.g. Lipitor, Crestor), but also related categories (e.g. fibrates), or other drugs made by the same firm (e.g. other cardiovascular drugs by Bayer).
Next to patients, doctors and firms there is another interest group that is important for the behavior before and after a drug withdrawal, namely the regulation agencies (e.g. FDA in US and EMA in Europe). Since drugs are often sold in multiple countries, it is interesting to see if, due to different regulatory systems, there are differences in withdrawals over countries. This leads to another form of spillover effects, i.e. across countries. For example, if a drug is withdrawn in the US, it is likely to affect sales/prescriptions in Europe, even if the drug is still on the market. An example is Cisapride, which was withdrawn in US, UK, and Germany, but was kept on the market in Australia and parts of Europe. The reason was that in these countries the regulations were stricter on the doses, and there were no alternative drugs available. This shows the heterogeneity over countries and the impact of the public regulators.
In addition to sales, the project looked at marketing expenditures. This allows to see the (dynamic) effects of marketing on sales. There are two interesting aspects of marketing related to drug withdrawals. First, studies on product-harm crises showed that marketing effectiveness changes after a shock (i.e. withdrawal) in the market, but none considered the spillover across categories. Second, the question is whether firms can do damage control through marketing? Firms generally know beforehand that the drug will be withdrawn. Hence, the firm can build goodwill by investing in marketing in the period before the withdrawal. I find that in some cases firms indeed build up marketing spend. In the next steps following this project, I will look closer to how this affects the remaining drug portfolio of a firm. This follow up will be by using the model I developed.
Given that previous studies on the aftermath of a withdrawal focus on the focal drug, this project explicitly focused on the spillover effects in the aftermath of drug withdrawals. There are two types of spillover effects I consider
(i) Across drugs (Do doctors start prescribing the competing drug, or has the withdrawal a negative spillover effect?), and
(ii) Across countries (If a country lags in withdrawing a drug, does the withdrawal in leading countries spill over?).