Editor's Note: The following letter was sent by Pfizer Senior VP Chuck Hardwick to Senator Mike Enzi (Wyo.), the chairman of the Senate Committee on Health, Education, Labor and Pensions. The letter serves as a preemptive counterpoint to Dr. Peter Rosts testimony to the committee.Dear Chairman Enzi:We understand that Dr. Peter Rost will testify today before the Senate Committee on Health, Education, Labor and Pensions on the subject of prescription drug importation. At the outset, it is important to note that while any citizen is entitled to speak before the Congress, Dr. Rost is not speaking on behalf of Pfizer. Dr. Rost has never been involved in the extensive analysis of this critical issue that has been undertaken at Pfizer. He has not participated in Pfizers active involvement in the governments examination of this issue. These Pfizer activities include the following:
- In April, Pfizers Vice President of Global Security, John Theriault, testified before the Department of Health and Human Services Importation Task Force, which was mandated by Congress to study the feasibility of importation. In May, Pfizer provided a submission to the Task Force that supports Pfizers position that foreign authorities do not have the controls in place to guarantee the safety of exported regulated drugs.
- Pfizer also participated in the GAOs study of drugs purchased online by helping determine whether these drugs are counterfeit. The GAO testified before a Senate subcommittee in June, concluding that consumers can easily buy drugs over the Internet without a prescription. The GAO concluded by stating, It is notable that we identified these numerous problems despite the relatively small number of drugs we purchased, consistent with problems recently identified by state and federal regulatory agencies.
- Unapproved, unregulated and counterfeit medicines bought online can (and do) come from virtually anywhere in the world. In light of the counterfeiting activity Pfizer has investigated, the importation proposals we have seen in Washington and some of the states are truly alarming. These programs open a tightly regulated system to a new drug distribution channel in which virtually every participant operates outside the law, outside the standards of acceptable medical practice and without effective oversight.
- In December 2003, the Minnesota Board of Pharmacy investigated eight Canadian Internet pharmacies and found 32 different unsafe or questionable pharmacy practices (on pre-arranged visits!), including unsupervised technicians performing pharmacist functions; shipping multiple labels unattached from multiple prescriptions in the same box; incomplete patient profiles; returned products re-labeled and resold; and unsafe storage and shipping, particularly of temperature-sensitive drugs. The Board investigators found that the standards followed by the Canadian Internet export operations varied greatly from pharmacy to pharmacysome "appearing to have few standards at all."
- A still larger concern is that consumers don't have any real idea about the true origin of the products. As the National Association of Boards of Pharmacy cautioned in its Position Paper on importation: "An order for what is purported to be a Canadian drug may never be filled by a legitimate Canadian pharmacy with a Canadian drug or even be filled in Canada. The well-known risks that all consumers take when purchasing over the Internet, where, for example, an anonymous company may be 'here today and gone tomorrow' or an illicit business is disguised as a legitimate organization, are heightened when purchasing foreign drugs."
- This concern is echoed in Prevention magazines detailed review of Internet pharmacy practices: Shoppers need to be aware of a deceptive tactic known as âhiding under the maple leaf: Web sites that advertise themselves as Canadian or prominently display the familiar maple leaf flag but are actually registered elsewhere.
- The dangerous nature of the products being shipped from foreign Internet pharmacies across the American border is exemplified by recent spot examinations conducted by the FDA and U.S. Customs. These found many shipments containing dangerous, unapproved and counterfeit drugs that pose serious safety problems. An overwhelming majority of the parcels violated U.S. laws and regulations because they contained unapproved drugs.
- Finally, a study by the head of the University of Michigan School of Public Healths Department of Health Management and Policy warns that federal drug importation would result in the loss to the state of thousands of jobs, decreased availability of U.S.-discovered medicines around the world, and diminished patient health benefits as a result of reduced future availability of new medicines from an overall reduction in R&D.
- In August, a UK health care agency issued an alert recalling two batches of Lillys Cialis when counterfeits were discovered after a patient reported to Lilly that his 20mg tablets were crumbly.
- In September, the same UK agency issued a second alert recalling a batch of Abbotts Reductil after counterfeits were spotted by a wholesaler after it became suspicious of the batch number.
