A Prescription for Safety

Buying drugs online may not be as dangerous as you think.

Why should Americans pay more -- often a lot more -- than Germans or Brits or Canadians for their drugs?

Pricey prescriptions are dead center in the finger-pointing going on in Washington's health-care reform debate, as Americans of all parties demand access to the cheaper drugs readily available in the rest of the world. Among the solutions congressional leaders are proposing is to legalize the importation of cheaper drugs from places such as Canada and the European Union, where governments restrict drug prices.

The plan would certainly lower costs, but will the drugs be safe? According to a recent study published by my research team, they could be a lot safer than you think. In fact, with the exception of fake Viagra with packaging from China, which not only didn't have the right active ingredient but could have contained a lethal one, none of the five drugs from the 26 Web pharmacies we assessed failed basic quality testing. Of the drugs that would be allowed to be imported under the new bill, all those we were able to test passed.

Yet so far, popular fear has paralyzed the legislation put forward by Sen. Byron Dorgan (D-N.D.) and Reps. John Dingell (D-Mich.), Bart Stupak (D-Mich.), and Frank Pallone (D-N.J.). Drug manufacturers argue that allowing widespread drug re-importation will increase the opportunities that counterfeiters and illegal operatives have to insert dangerous products into the supply chain. They seem to have a point. Well over a hundred deaths have been attributed to counterfeit products, often diverted through Europe (though most were made in China, not in the European Union). Drug companies might also suffer if prices fall too much; it costs hundreds of millions of dollars to take a drug from development to market, and high prices in the United States explain how they're able to afford it for now.

But while Congress vacillates, the American public is already turning to the Internet to source cheaper drugs. In fact, consumers in the United States have been doing so for years. Surveys indicate that Americans are concerned about Internet drug quality -- yet millions buy online. The market is already more than $12 billion a year. For the elderly and isolated in particular, convenience and low cost outweigh the potential harm of using Web pharmacies.

Certainly, there are still risks to buying drugs this way. Twenty percent of the drugs we ordered, for example, didn't come as requested; instead of a name-brand drug, a substitute product was delivered. Because these drugs could not be tested accurately using our equipment, there is certainly room for concern.

This shouldn't be enough of a problem to stall common-sense legislation, though. The World Health Organization reports that drugs from Web sites that conceal their physical address are counterfeit in more than 50 percent of cases. And indeed, the few drug failures in our analysis came from Web sites lacking a physical address. Our research suggests that even non-approved Web sites (those breaking U.S. law by not requiring prescriptions and importing drugs) that at least have a physical address will deliver decent-quality brand drugs -- albeit illegally.

Contrary to what one might expect, we also found that price was no indicator of quality. Drugs from India, which were marked up 20-fold from their local retail price, passed our basic quality test. But so did those from Europe that were not only illegally diverted, but were probably stolen -- and sold at a heavy discount. And with the exception of Viagra, whose price was cheaper on less regulated sites, drugs were less expensive on the better, U.S.-approved sites than on less regulated and even rogue ones.

It's true our sample size is fairly small. But if replicated by further studies, the conclusion is clear: Though there remains a clear risk to buying cheaper drugs over the Internet, as long as the requested drug brand is delivered and the site has a physical address, contactable by phone, the risk is really pretty small.

Such a conclusion undermines the fear-based argument being used to oppose importation; if word gets out that imported drugs aren't so bad, the stalled legislation might even pass Congress. Of course, that could lead to another problem: We all may well suffer if drug companies' profitability -- and research budgets -- are cut.



How Ahmadinejad Stole an Election -- And How He Can Fix It

In June, 40 million Iranians voted in their presidential election. The degree of tampering and fraud has made it impossible to determine the winner -- and has heightened the need for reasonable changes to create free and fair elections.

Rarely does a country have such a clear choice as Iran did on June 12. On that day, nearly 40 million people voted for a president.  The incumbent, Mahmoud Ahmadinejad, pledged to continue his economic policies and his anti-Western, Holocaust-denying, nuclear-confrontational approach. His main opponent, Mir Hossein Mousavi, promised economic reform, increasing openness with the West, human rights, and nuclear negotiations.

While some polling stations were still open, the Interior Ministry declared Ahmadinejad the winner by a landslide. The opposition rejected it, and despite arrests and beatings, the protests have continued. Ahmadinejad's and Mousavi's supporters both proclaim their candidate won.

But to all others, it is clear there were substantial irregularities. Although Ahmadinejad's crackdown appears designed to end questions about his legitimacy, even conservative clerics are demanding answers from the state. Here is what we know happened -- and a plan to prevent fraud in the next election.

Using even a minimal standard, there are good reasons for Iranians not to trust election results. The president-controlled Interior Ministry conducts elections in Iran. It denies opposition observers access to polling stations and counts the votes. Only half of Mousavi's observers were permitted to observe polling stations in the capital city of Tehran; they had even less access in the rest of the country. None of the observers were permitted to see whether the ballot boxes were empty when the vote began. Nor were they permitted to accompany the mobile ballot boxes, which collected nearly one-third of the votes. And no Mousavi or impartial observers accompanied the ballot boxes from local wards to the provincial committees and finally to Tehran for the count.

Before the election, the reformists' Committee for Safeguarding the Votes expressed concern that 54 million ballots were printed -- millions more than for past elections and 8 million more than the number of eligible voters. Moreover, some ballots did not have serial numbers. About 40 million people voted, but no one accounted for the other 14 million ballots.

The Committee for Safeguarding the Votes also said it found a large number of Mousavi votes after the election, including some in the northern forests of Iran. It surmised that these votes were removed from the boxes and replaced with votes for Ahmadinejad. Mousavi himself claims he has evidence that the total number of votes exceeded the number of eligible voters by as much as 40 percent in more than 170 constituencies. Some of the party observers claim ballots for Ahmadinejad featured the same handwriting in the same ink.

These accusations of fraud are credible. Even the conservative Guardian Council has acknowledged that as many as 3 million votes might have been fraudulent. But, given the way the system operates, no one knows with certainty how many votes were legitimate and how much fraud occurred.

In many other countries with rigged electoral systems, opposition members boycott. That did not happen in Iran -- and now, millions are risking their lives to compel the authorities to count their votes accurately. As the protest moves to its next phase, the country could stave off a crisis by agreeing to four fundamental electoral safeguards.

The single most important step is to transfer election responsibilities from the Interior Ministry and the Guardian Council to a nonpartisan and independent national election commission. Iran should also create a nonpartisan elections court, composed of judges and lawyers. All the major political parties should have a veto on nominees so as to ensure that the judges are acceptable to all the parties.

Second, the Election Commission should certify the candidates according to clear and fair criteria, and they should prevent any intimidation, and guarantee access to the entire electoral process by domestic and international election observers. Domestic observers are absolutely essential to assuring a free election and detecting fraud; and international observers help the process by magnifying the voice of the domestic observers.

Third, the ballot boxes should be opened for all to see before the election begins, and observers should accompany mobile and other ballot boxes through the day.

Finally, counting should occur at every polling site. Observers should watch the count, sign the declaration of results, and keep a copy. The final announcement should publicize the results of each of the polling stations, so that people can detect any vote discrepancy.

Much else needs to be done to build confidence in the electoral process and assure votes are counted fairly. But if these four fundamental elements of electoral reform are accepted and implemented, the next election in Iran would be much freer and fairer. The reforms would also allow Iranians and the world to locate and denounce any fraud. The opposition has asked for a new election, but without these four reforms, that is unlikely to be any fairer than the previous one. Only with such reforms can Iranians know when their votes count, and when their voices are stolen.

What role should the West and the United States play at this time? It is obvious that Ahmadinejad and his allies would like to blame all of Iran's problems on the West -- especially the United States and Britain. The government's case against the opposition is that its members are surrogates of the West. For these countries to be seen as meddling in Iran's affairs would be counter-productive.

On the other hand, the democratic community cannot be silent; it needs to find the most appropriate and legitimate way to express its support for democracy in Iran and elsewhere. The best way to reconcile these two somewhat conflicted messages -- avoid meddling but provide more support for Iran's democrats -- is if the world's great Muslim democracies, which have diplomatic relations with Iran -- like Indonesia and Lebanon -- to carry the message. Those countries should propose a resolution to the U.N. Human Rights Council, calling for an end to repression and for genuine electoral reform.

It now appears that Ahmadinejad will try to consolidate a hard-line government and will ruthlessly suppress all legitimate protest movements. If he chooses this path, he will further undermine his efforts to win legitimacy.

The battle for reform has just begun. The only question is when it will prevail. Within Iran's regime, a group of clerics holds that the Islamic Republic should be genuinely democratic. In the end, the major hope for democracy will depend on their acknowledging the flaws in the electoral system and deciding to reform it.

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