Posted by ghost on September 28, 2004, at 8:09:21 [reposted on September 28, 2004, at 22:41:50 | original URL]
In reply to Re: ordering from Canada » Emme, posted by Larry Hoover on September 24, 2004, at 7:18:43
> In an astounding break from policy, Dr. Rost, a vice-president at the world's largest pharm co., Pfizer, testified (two days ago?) to a Congressional committee that the risks of obtaining drugs from Canada are vastly overstated, and false.
This is Pfizer's response to Dr. Rost's statement of opinions:
Dear Members of Congress:
We understand that you have invited Dr. Peter Rost to join in a press conference and panel discussion on drug importation on September 23.
Dr. Rost has no qualifications to speak on importation, no responsibilities in this area at Pfizer, no knowledge of the information and analysis Pfizer has provided to the government on this issue, and no substantive grasp of how importation may impact the safety of this nation’s drug supply.
Dr. Rost’s sudden interest in importation came as a surprise, simply because he had never made any effort to participate on the team of Pfizer experts that has been studying the issue in depth.
Dr. Rost’s personal opinions on importation would have benefited from the extensive analysis of Pfizer’s importation team, which includes supply chain experts, security professionals and executives with backgrounds in regulatory and cross-border issues.
For example:
In April, Pfizer’s Vice President of Global Security, John Theriault, test ified 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 Pfizer’s position that foreign authorities do not have the controls in place to guarantee the safety of exported regulated drugs.
Pfizer also participated in the GAO’s study of drugs purchased online by helping determine whether these drugs are counterfeit. The GAO test ified 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.”
These activities reflect Pfizer’s active involvement with the government on the issue of drug importation. Dr. Rost has had no involvement in this effort because he has no expertise relevant to the subject, and we believe he is doing a disservice to the American public and to those who believe in informed debate by issuing a series of personal opinions and asides that bear no resemblance to the facts regarding the risks of drug importation.
The issue of importation and how it may impact the safety of American patients is a serious health issue requiring informed debate. In 1987, Congress enacted important changes to prohibit the importation of unapproved medicines in response to many instances of unsafe foreign medicines entering the U. S. While the public health threats caused by such medications were significant enough in 1987, the potential threats from unapproved prescription drugs are even greater today.Here are a few key points that need to be factored into the discussion:
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 pharmacy - - some "appearing to have few standards at all."[i]
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[ii]: "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 magazine’s detailed review of Internet pharmacy practices: “Shoppers need to be aware of a deceptive tactic known as ‘hiding under the maple leaf’: Web sites that advertise themselves as Canadian or prominently display the familiar maple leaf flag but are actually registered elsewhere.”[iii]
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 new study released this week by the head of the University of Michigan School of Public Health’s 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.[iv]
The situation overseas is no better. Notably, in just the last two months the UK suffered two high-profile counterfeit cases involving fake medicines in the legitimate supply chain:[v]In August, a UK health care agency issued an alert recalling two batches of Lilly’s 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 Abbott’s Reductil after counterfeits were spotted by a wholesaler after it became suspicious of the batch number.And on parallel trade, Dr. Rost is wrong. He incorrectly suggests that the price differences exploited by parallel trade in Europe have been passed on as savings to consumers. Parallel trade in Europe involves trade between pharmacies and wholesalers subject to appropriate regulations in their respective home markets. It does not involve individuals importing medicines on their own from foreign jurisdictions. Our long experience analyzing parallel trade shows the gains ultimately accrue to the middlemen rather than to consumers.
This view was supported by a recent London School of Economics study, which found that 50 to 89 percent of the potential gain to consumers from parallel trade is, in fact, realized by the parallel traders.[vi]
The extent of counterfeit medicines in the UK is unclear. However, at the end of 2000, the Centre for Economic Business Research claimed that six percent of the drugs in the UK were probably fake.[vii] Pfizer believes that international counterfeit operations are clearly targeting Europe ’s legitimate supply system. It is time to re-examine the weakest point in the chain – the repackaging of original manufacturers’ medicines by parallel traders.
To provide additional perspectives, attached please find an in-depth review of counterfeit medicines and the issues surrounding them.
We strongly believe these perspectives should inform public discussion on the dangers of importation.
Sincerely,
Chuck Hardwick
Senior Vice President Worldwide
Government & Public Affairs
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[i] Minnesota Board of Pharmacy Office Memorandum, at 2 – 5 (December 24, 2003 ).
[ii] National Association of Boards of Pharmacy Position Paper on the Importation of Foreign Prescription Drugs, March 2003.
[iii] “No Prescription? No Problem,” Prevention.com http://www.prevention.com/cda/feature2002/0,2479,s1-6568,00.html.
[iv] “Prescription Drug Importation, Investment and Employment in Michigan,” Dean G. Smith, Ph.D., Professor and Chair of the Department of Health Management and Policy, School of Public Health, University of Michigan, Sept.21, 2004.
[v] “Counterfeit Drugs Set Alarm Bells Ringing,” Pharmaceutical Journal, 11 September 2004 , p1.
[vi] P. Kanavos et al., London School of Economics, “The Economic Impact of Pharmaceutical Parallel Trade: A Stakeholder Analysis” (2004).
[vii] “Fake medicines cost £180m, says ACG,” Pharmaceutical Journal, 23/30 December 2000, p905.
poster:ghost
thread:396611
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