By Albert Samaha
By Steve Weinstein
By Devon Maloney
By Tessa Stuart
By Alison Flowers
By Albert Samaha
By Jesse Jarnow
By Eric Tsetsi
As anthrax infections continue to crop upmost recently and ominously without a known sourcethe mounting stockpile of the favored anti-anthrax drug, Cipro, has become our collective comfort. "In Cipro We Trust," anchorman Tom Brokaw told the nation a few weeks back. And since then, the government has put its faithand moneyin Cipro's maker, Bayer, in the form of a contract for 100 million doses of the drug with an option for 200 million more. Helge Wehmeier, Bayer's president and CEO, has been praised for having reduced Cipro from $1.77 to 95 cents a pill for the first batch, a price he's agreed to further slash to 85 cents for the next 100 million. "You can't have a bookkeeping approach" in a national emergency, Wehmeier said of his pricing policy.
Rather than simply thanking Wehmeier for the $82 million discount, though, Americans might well be asking why we're still paying a staggering $95 million for a drug that costs just cents to manufacture. Comparison shop and Cipro's 95-cent price tag hardly seems like a bargain. Bayer sells Ciprothe bestselling antibiotic in the world, which is also used to treat common ailments such as urinary tract infections and bad coldsto another government program for a mere 43 cents a pill. Generic versions of the drug are available in other countries for roughly 10 cents. And on October 27 the government contracted to buy 1.2 billion doses of doxycycline, a generic drug with fewer side effects, for an estimated 3 cents each. Indeed, with doxycycline now approved to treat anthrax exposure, it's unclear why we need Cipro at all.
In response to suggestions that Wehmeier should have lowered his price a wee bit furtheror even waived the government fee entirely, since the company is making a mint on retail salessome in the press have leaped to the company's defense. "Profits are the reason that drugs like Cipro exist in the first place," James Surowiecki wrote in The New Yorker. In its profile of the executive, the Times portrayed him as the victim of a PR crisis. But Wehmeier may have mounted his best, or at least most truthful, defense himself: About the fact that his company is making a profit on this potential health crisis, the CEO said, "That is the American way."
Indeed, the run on anthrax-fighting antibiotics has merely provided a window onto the choke-hold tactics that are business as usual for giant pharmaceutical companies. While the anthrax scare has boosted sales, pharmaceutical companies were already towering over others in the Fortune 500, with profits averaging more than 18 percent of revenues, as opposed to just over 4 percent for the rest. The Pharmaceutical Research and Manufacturers of America argues these whopping yields are necessary to propel the drug companies' creative research. But the industry may be most inventive when it comes to patents, the intellectual-property-right protections that, throughout the last decade, have been used to roughly double the amount of time companies can reap profits on brand-name drugs. (The average drug patent lasts just over 14 years.)
Consider, for instance, the unseemly deal to protect Cipro's patent that recently came to light: In 1997, Bayer paid three generic-drug companies $200 million to stop challenging its 14-year-old patent on the antibiotic, which has generated more than $1 billion in sales in the U.S. alone. Barr Laboratories, a generic-drug maker, had sued Bayer, claiming its patent was invalid. When a judge found the claims against Bayer worthy of a trial, the companies struck the deal: Bayer continued to market Cipro exclusively, and Barr and two other generics companies took the money and dropped the case. Meanwhile, the consumer can still pay nearly $5 a pill for Cipro in the drugstore.
In a suit filed October 25, the Boston-based Prescription Access Litigation (PAL) project charges that the Bayer settlement amounted to an illegal payoff that swiped money from American consumers. Indeed, one of the five generic companies pre-approved to make the antibiotic when Bayer's patent ends in 2003 has already said it would sell the non-brand-name drug for a mere 40 cents a pill. Had the generic companies been allowed to sell the cheaper version, taxpayers might have saved $55 million in just the first installment of our government's Cipro deal.
Even more outrageous, though, is the fact that this shady manipulation of patent rights is rampant within the pharmaceutical industry. While the Bayer boondoggle came to light because of the national attention now focused on anthrax and Cipro, "it's almost inevitable that [a manufacturer of] a high-selling drug will engage in some form of abuse of its monopoly," says Thomas Sobol, one of the lead lawyers for PAL, which has filed suits over the inflated prices of six other prescription drugs in the past year.
Patents are supposed to reward scientific innovation. But the system that's meant to spur corporate creativity has instead stifled it. Sixty percent of the "new" drugs approved by the Food and Drug Administration in the 1990s were actually just new formulations or combinations of already existing ones, according to a recent report by the National Institute for Health Care Management. These "me, too" drugs allow companies to extend patents for a decade or more, while consumers continue to fork over brand-name prices that average three times generic ones.
Drug companies have come up with other ingenious ways to extend their patents: Schering-Plough patented both metabolized and purified versions of Claritin, stretching its exclusive marketing rights on the antihistamine to a total of over 21 years. Glucophage was granted special patent protections intended to promote pediatric research, even though the medication for adult-onset diabetes seems of little value to kids. And Bristol-Myers Squibb lengthened its Taxol patent by employing protections for drugs that treat uncommon diseaseswhich Taxol does. But the drug is also widely prescribed for breast cancer, and the typical course of treatment for that disease now runs about $20,000, reportedly more than 20 times what the drug costs to produce.
In the midst of what seems to be a biological attack, there was, in the case of Cipro, a perfectly legal high road leading away from such tawdry tactics. The patent law includes a clause that allows the government to override exclusive marketing rights during a public health crisis. New York Senator Charles Schumer suggested this route in the U.S., and in Canada, the government almost took it. Such moves would have set an important precedent, particularly for international health advocates who are primed for an upcoming World Trade Organization conference where drug patents will be front and center. Mostly they'll be talking about AIDS, which has killed some 22 million people worldwideand might have killed far fewer had cut-rate drugs been made available to people in developing countries.
A true break on Cipro might have made a dent in the pharmaceutical industry's armor. Instead, while feigning stern negotiations, the Bush administration gave Bayer what amounted to a loving squeeze. "It was a missed opportunity," says Larry Sasich, a pharmacist who keeps tabs on the drug industry for Public Citizen. Sasich has seen such close calls before, starting 40 years ago when Congress rejected a bill that would have forbidden drug companies from patenting minor chemical changes unless they were truly superior. Sasich is also dubious about the prospects of future efforts. "Other opportunities to take on [the drug companies] will come up in the next few years," he predicts, "and we'll miss those, too." It is the American way.