ElderWeb

The U.S. Food and Drug Administration (FDA) commissioned a study from a company called Cyveillance which states that of 11,000 "Canadian" Internet pharmacy sites they researched, most just redirect users to 1,099 sites that actually sell prescription drugs, and of the 1,009 sites that sell "Canadian" drugs, only 214 are actually based in Canada.

This raises many troubling questions and should justifiably frighten anyone buying drugs online, but little futher information was provided. I was not able to find any information about the study on the FDA web site at all, and only the press release is available on the Cyveillance site. The press release has been reproduced verbatim on numerous online and offline news outlets, but I only found one article, a story by Brian Krebs of the Washington Post, that seems to have dug further into the story (see it at http://www.washingtonpost.com/). Krebs tried to get additional information about the study, but was not able to find out which drug sites are actually located in Canada and was told by a FDA spokeperson that revealing that information would give Americans a "false sense of security" and that "as long as shipping medications into the United States remains illegal, the agency would continue to refuse to work with any entity supporting that activity."

I thought it would helpful to provide some tips to try to avoid problems when buying prescription drugs on the Internet:

1) Don't follow links in emails that offer Canadian drugs. One of the few bits of information in the press release was the fact that most of the bogus sites are only reachable via spam email links and cannot be found via legitimate search engine searches.

2) Many legitimate American sites will be be registered with the Verified Internet Pharmacy Practice service (VIPPS). Check their list at http://www.nabp.net/vipps/. Legitimate Canadian pharmacy sites can be found at the Canadian International Pharmacy Association (CIPA) at http://www.ciparx.ca/. If you don't see the site on one of these lists, you probably should avoid it.

3) CIPA also offers a list of tips on their web site to help ensure you are dealing with a legitimate Canadian pharmacy business, including suggestions to look for a Canadian Provincial pharmacy license number and a Canadian phone number (and to call that number to be sure it is legitimate). Consumers should also expect legitimate sites to require a prescription from a licensed physician.

The Clinton administration killed a program created by Congress to allow imports of low-cost prescription drugs. The administration said the import plan would not be safe and would not save money for consumers. Donna E. Shalala, the secretary of health and human services, said the program was severely flawed. Even though President Clinton had previously questioned the feasibility of the program, expressing doubts even as he signed it into law, the timing of Dr. Shalala's finding was a surprise. The Clinton administration could easily have left the issue to President-elect George W. Bush, but instead invoked a provision of the law to abort the program.

In her letter, Dr. Shalala said the drug-import law had at least three "flaws and loopholes":

- Federal laws requires government-approved labeling on any prescription drug sold in this country, and drug makers could block imports of medications by denying importers access to those labels.

- Authority for the import program would have expired after five years. Wholesalers would have been reluctant to buy the equipment needed to test and distribute imported drugs because they could not be sure of ''long-term financial returns.''

- Drug makers could have thwarted the intent of Congress by requiring drug distributors to sell imported drugs at high prices.

The purpose of the measure was to help Americans gain access to prescription drugs at the lower prices charged in foreign countries that regulate drug prices. The law allowed pharmacists and wholesalers to import prescription drugs that meet federal safety standards. After working out details of the legislation in October, Congress at the last minute added a proviso saying that it would take effect only if the secretary of health and human services demonstrated to Congress that it would "pose no additional risk to the public's health and safety" and would "result in a significant reduction in the cost of covered products to the American consumer" and Dr. Shalala said she could not make either showing.

Individuals can still buy drugs from abroad. Consumers cross the border and buy medications in Canada or Mexico or buy drugs from foreign countries over the Internet. Federal officials have expressed concerns about both types of purchases, but they say that they generally do not challenge consumers importing small quantities of prescription drugs for personal use.

>> HR 4461

Irving Levin and Associates conducted a survey of online pharmaceutical sites. The survey compares publicly traded companies PlanetRx.com, HealthCentral.com, and drugstore.com with real world stores CVS.com and Walgreens, and privately owned more.com (which will soon be purchased by HealthCentral.com.) They purchased at a standardized list of pharmacy items from the online sites, then compared them with the same items at the local CVS store.

They found numerous problems with the online services. Using the search engines to find specific items required the shopper to try typing in several variations of a brand or item name since results were either too few or too numerous. Web site errors at Drugemporium.com (owned by HealthCentral.com) and Walgreens.com forced the user to stop shopping and try again later before an order could be processed. Calling the toll-free help lines resulted in long waiting time, followed by scant insight into a reason for the error and no solution to the problem. A discrepancy was found between the online invoice and the delivery invoice from Drugemporium.com. Most of the online pharmacies offered house brand savings (Drugemporium.com also offered several coupons), and all charged $3.50 - $4.45 for delivery in up to 5 business days. Comparatively, at the local bricks-and-mortar drugstore, consumers can purchase and walk out with the same name-brand items for only about 5% to 10% more in cost.

Their conclusion -- online drug sales sites still have lots of work to do.

New regulations in New Zealand will prohibit sales overseas of prescription medicines to individuals who do not have a prescription from a New Zealand authorized prescriber. The requirement to have a New Zealand based prescription will restrict the ability of overseas consumers to purchase medicines from New Zealand pharmacies which would require medical supervision to use safely. The regulations were issued in response to a growing number of Internet pharmacy sites (at least 30 in New Zealand) that are involved in Internet drug sales to people overseas.

The move follows a court case late last year which highlighted a limitation in the New Zealand law allowing such sales to occur to overseas customers. It has always been illegal for New Zealand pharmacists, GP's or any other medical practitioners to provide prescription medicines to New Zealand consumers over the internet, or by any other means, without evidence of a written prescription by a NZ registered practitioner. However, that same protection had not been available to overseas consumers.

The Medical Council of New Zealand also has strict guidelines about doctors prescribing medicines over the internet. These guidelines require the doctor and patient to have met on at least one occasion, and for the patient to be under the care of that doctor.

There has been lots of discussion in the press lately about the disparity between drug prices in the United States and that in other countries. There have been many stories about seniors driving to Canada or Mexico to buy drugs at prices significantly lower than prices they could get in the United States. Unfortunately, current federal law makes this an illegal practice, although it is not usually prosecuted. In a really dramatic presentation, Senator Byron Dorgan of North Dakota took a bus load of seniors across the Canadian border, where they bought drugs at significantly lower prices than in the United States. He then stood before the Senate and held up identical bottles of pills, some purchased in the U.S. and others in Canada, to illustrate the price differences. According to a study by the Government Accounting Office (GAO), prices in the U.S. are, on average, about 34 percent higher than in Canada for the same FDA-approved medicines, manufactured in the same FDA-approved factories, and often even packaged and sold in the same bottles. It is not unusual for Americans to be charged two, three, and even ten times as much for the same prescription medicines than consumers in other countries.

Legislation to make drug imporation legal was added as an amendment to HR 4461, the appropriations bill for the Food and Drug Administration (FDA) and other agencies. The "Medicine Equity and Drug Safety Act of 2000" passed the Senate by an overwhelming vote of 74 to 21 last July. The amendment was authored by Senator Jim Jeffords (R-VT), chairman of the Health, Education, Labor, and Pensions Committee and Senator Byron Dorgan. The amendment would allow wholesalers and pharmacists to import FDA-approved prescription drugs and would establish a new safety system intended to track these imports and test them for authenticity and degradation. Efforts are under way to hammer out a compromise bill and get it passed before Congress adjourns October 6. The plan made major gains this week, picking up endorsements from President Clinton, Senate Majority Leader Trent Lott (R-MS) and Speaker of the House Dennis Hastert (R-IL). Senate and House Minority Leaders Tom Daschle (D-SD) and Dick Gephardt (D-MO) also support the plan.

Opponents, including the drug manufacuring industry, said that the bill would jeopardize the safety of Americans, since bans on imported drugs were originally implemented to protect Americans from counterfeit or adulterated drugs. This law was passed in 1988, and states that only the drug manufacturer may import pharmaceuticals into the U.S., making criminals out of consumers who bring in small quantities of drugs from other countries. They have been successful in getting adjusting the language of the bill to state that, before this provision could take effect, the Secretary of Health and Human Services would be required to certify that the regulations would pose no risk to the public health and significantly decrease prices paid by consumers.

The White House estimates the FDA will need an additional $23 million a year in order to develop and implement a process to oversee foreign drug plants. The FDA says it will need $90 million more a year.

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Testimony of Senator Byron Dorgan of North Dakota

I have here bottles of 3 different prescription drugs that are ranked among the top 20 in the United States in the number of prescriptions filled and sales volume. All of these drugs, incidentally, are approved by the U.S. Food and Drug Administration.

I have here the actual bottles for these medicines. This one happens to be Zoloft, which is used to treat depression. The company that produces these pills and puts them in different size bottles then sells them all around the world. It is exactly the same medicine produced by the same company, sold in different places. Buy it, for example, in Emerson, Canada, and you will pay $1.28 for a pill. Buy it 5 miles south of there in Pembina, ND, and you will not pay $1.28 for the same pill. Instead you will pay $2.34. It is the same pill in the same bottle, made by the same company in the same manufacturing plant. The only thing different is the price. The pill costs $1.28 in Canada, and $2.34 for an American consumer.

Or what about Zocor? Zocor is a very popular prescription drug. Pick up any Newsweek or Time magazine and see the multipage ads for this drug. I have here two bottles of Zocor made by the same company, with the identical manufacturing process. One bottle is sent to Canada where it costs $1.82 per tablet; the other is sent to a U.S. consumer who is charged $3.82: $1.82 for someone living in Winnipeg, $3.82 for someone living in Montpelier.

Norvasc is a prescription drug that is used to lower blood pressure. The bottles are almost identical--again, both bottles are by the same manufacturer, and contain the same pill. Norvasc costs the Canadian consumer 90 cents. It costs the U.S. consumer $1.25 per pill.

Or to look at this price disparity another way, the cost of a 1-month supply of Zocor--the same pill, by the same company, in the same bottle--is $54 when it is sent to a Canadian. When it is sent to an American, it costs $114.

Or Zoloft--again the same pill, by the same company, made in the same manufacturing plant--costs the Canadian $38 for a 1-month supply; the American pays $70.

Norvasc costs Canadians $27 for a one month supply and the same quantity costs Americans $37. I can show you medicine where the price inequity is 10 to 1.

The question our constituents in the States of Vermont, North Dakota, Minnesota, and Washington ask is: How can this be justified? This is the same product. If this is a global economy, why must I go to Canada to try to buy a prescription drug that was manufactured in the United States in the first place in order to buy it for half the price? That is what Americans all across this country are asking.

The companies that produce these medicines are able to access all of the ingredients they need to produce prescription drugs from all around the world in order to get the lowest prices. If the pharmaceutical manufacturers are able to benefit from the global economy, why then can the consumer not also access that same drug made in a plant approved by the FDA when it is being sold in Winnipeg for half the price?

What is the answer to that? Many of us believe American consumers should be able to also benefit from the global economy. My colleague from the State of Washington, Mr. Gorton, has sponsored his own legislation to address this issue and he is also a cosponsor of this amendment. All of us have to respond to our constituents.

This is not just a Canada-United States issue. Americans pay higher prices than anywhere else in the world. How much more do we pay? If Americans pay an average of $1 for a pharmaceutical product, that same product has a much lower average cost in every other industrialized nation. We pay $1; the Canadians pay 64 cents. We pay $1; the English pay 65 cents. We pay $1; the Swedes pay 68 cents. We pay $1; the Italians pay 51 cents. We are charged the highest prices for prescription drugs of any country in the world. The American people ask the question: Why?

Senior citizens are 12 percent of our population, but they consume one-third of the prescription drugs in America. I come from a State with a lot of senior citizens. They have reached the years of their lives where, in most cases, they are no longer working and are living on a fixed income. Last year, they saw, as all Americans did, prescription drug spending in this country go up 16 percent in 1 year. Part of that is price inflation, part is driven by increased utilization. Nonetheless, older Americans saw a 16-percent increase in prescription drug spending in this country in 1 year.

Those of us who have held hearings on this issue and who have heard from senior citizens know what they say. They tell us they are forced to go to the back of the grocery store first, where the pharmacy is, to buy their prescription medicines because only then will they know how much money they have left to pay for food. Only then will they know whether they are going to get to eat after they have purchased their prescription drugs.

This is an issue for all Americans, not just senior citizens, but it is an especially acute problem for senior citizens.

In January on one cold, snowy day, I traveled with a group of North Dakota senior citizens to Emerson, Canada.

First we visited the doctor's office--because it is required in Canada--where the North Dakotans who wanted to buy prescription drugs in the Canadian pharmacy showed the doctor their prescription from a U.S. doctor, and the Canadian doctor wrote a prescription for them. Then we went to a very small, one-room pharmacy just off the main street of Emerson, Canada, a tiny little town of not more than 300 or 400 people. Emerson is 5 miles north of the North Dakota border.

I stood in that pharmacy and I watched the North Dakota senior citizens purchase their prescription drugs, and I saw how much money they were saving on the prescription drugs they were buying.

As is often the case, senior citizens will take 2, 3, 4, or 8 different prescription drugs. It is not at all unusual to see that.

I watched these North Dakotans compare what they were paying in the United States to what they were paying at this little one-room pharmacy in Emerson, Canada. It was staggering.

They asked me the question: Why do we have to come to Canada to do this? Why can't our pharmacists come up here and access this same supply of drugs and pass the savings along to us?

The answer is that there is a Federal law in this country that says that only the manufacturer can import prescription drugs into the United States.

The amendment we are considering, offered by the Senator from Vermont, proposes to change that. He does not propose to do so in any way that would jeopardize the safety of medicines that are available in this country. He does not propose to in any way suggest that we should not maintain the chain of custody needed to assure a safe supply of prescription drugs.

But he does propose that we amend that law and replace it with a system that assures the safety of the medicine supply, while allowing pharmacists and drug wholesalers to go to Canada and go to other countries and access that same prescription drug, provided that it was produced in a plant that was approved by the FDA. This amendment assures not only the safety of the manufacturing process but also the chain of custody of the supply. In this way we will allow U.S. consumers the full flow and benefit of the global economy.

Why can't American pharmacists and drug wholesalers shop globally for prescription drugs, provided it is the same pill, put in the same bottle, manufactured by the same company in a plant that is approved by the FDA?

The answer is that they ought to be able to do that. There is no excuse any longer for preventing them from doing that.

Zocor, Prilosec, Zoloft, Vasotec, Norvasc, Cardizem--you can go right on down the list of the medicines most frequently used by senior citizens and compare what they cost here with what they cost in Canada and Mexico. Then ask the question: Why? Why are we in America charged so much more for the identical prescription drug?

The answer is simple: It is because the big drug companies can do it here. The pharmaceutical industry charges what the market will bear in the United States. The U.S. consumers are prevented from being a global consumer.

Let me say this about the pharmaceutical industry. I want them to do well. I support them on a range of things. I want them to be profitable, and I want them to be able to do substantial research. I do not wish them ill. I applaud them and thank them for the research they do to create lifesaving, miracle drugs. They only do part of the research, of course. A substantial part is also done through the National Institutes of Health, through publicly funded research. And we are dramatically increasing our investment in NIH.

But some will say to the Senator from Vermont: What you are doing will dramatically reduce research and development by the drug companies. These prices are what support research and development.

Hogwash. Nonsense. The fact is, a larger percentage of the research and development is done by the drug companies in Europe than is done in the United States. Let me say that again. More research and development is done in Europe than in the United States. And that comes from the pharmaceutical industry's own figures.

Take a look at the billions and billions of dollars the drug industry spends on promotion and compare that to what they spend on research and development.