one would be hard-pressed to find two more different patients in need of the AIDS wasting treatment Serostim than Kelly Burke and Rick Roberts. Where Roberts is proactive and involved in his medical care, Burke is distrustful of the medical system and tries to avoid physicians at all costs. And where Roberts stopped taking his Serostim the moment he became suspicious the substance was not what it purported to be, Burke continued taking the alleged drug even though it seemed to be making her deathly ill. The one thing that Roberts and Burke most definitely share is they both received, and injected, counterfeit Serostim from what they thought were safe and reputable sources -- their respective pharmacies in Berkeley and San Francisco. Both pharmacies are, coincidentally, run by CVS Procare, a drugstore chain that owns some 4,150 pharmacies around the nation.
Roberts became suspicious when his injections suddenly started burning. "I asked a pharmacist about it, and he casually mentioned that there are fake [drugs in circulation] and that I should check my box [of drugs], but he did not tell me what I should check for. The result was that I had injected two different versions of the counterfeit hormone...and [I] spent the next five or six weeks having nightmares...[about] what I had done to myself."
Kelly Burke's situation was even more nightmarish. She obtained her doses of what turned out to be counterfeit Serostim from the CVS Procare pharmacy (formerly the privately owned Lyckberg Pharmacy) on Telegraph Avenue in Berkeley. "It started off with welts at the injection site and real soreness. And then it proceeded to vomiting with a fever, and as I used it daily it just got worse and worse. I could not hold water down. I felt I was going to die. I felt sure I did not have much time left at all.... To think about it now makes me mad!"
Burke was injecting what she now believes was a counterfeit substance, from November of last year through this spring. She only realized she might be taking a fake drug after moving to San Diego and seeing an article in a local gay paper alerting HIV-infected people to the problem. Sure enough, when she checked her prescription's lot number, she found she had been given a batch of phony drugs.
Serostim is a human growth hormone that builds lean body mass, bone, tissue, and organ muscle and is particularly valuable to those subject to AIDS wasting. The drug is extraordinarily expensive at $21,000 for a twelve-week course and has, unfortunately, come to the attention of the bodybuilding set. "There has been a lot of diversion of legitimate drugs for illegitimate purposes," asserted Dr. John Stansell, acting chief medical director of the Positive Health Program at San Francisco General Hospital. "There is a huge industry using growth hormones much as anabolic steroids have been used in the past to bulk up. You can almost pick these folks out at the gym. I have seen several unfortunate cases of people who look like Neanderthals: large jaws, large joints, frontal bossing over the forehead."
It is not known is just how many others are in the same boat as Roberts and Burke. Larry Kurtz, vice president of McKesson, one of the nation's largest pharmaceutical distributors, confirmed that nationwide the company has recalled "hundreds of doses, probably."
"We know that we had counterfeits," Kurtz admitted, "and some were distributed to pharmacies, but they have been recalled."
The federal Food and Drug Administration believes the numbers of actual individual patients who obtained the counterfeit drug nationwide are small. While FDA spokesperson Laura Bradbard noted that reports of the counterfeit drug have come in from around the country, she stated most of the discoveries have come from distributors, not individual consumers.
Though many knowledgeable observers agree with the FDA estimate, some suspect the actual number of individuals affected are an extremely small fraction of the 6,000 AIDS patients taking Serostim nationwide. Nonetheless, the fake drug can be devastating when it falls into the hands of HIV-infected individuals. "You are often giving it to a patient who is immune-compromised anyway, so even the slightest problem could cause complications," said one industry source who requested anonymity. "Then people die and people say they were sick all along."
Initial reports of counterfeit Serostim surfaced last November and then again in May (there were also reports of the counterfeiting of two other expensive drugs). Though the FDA's Office of Criminal Investigations promptly launched an inquiry, the agency has been exceedingly closed-mouthed about its investigation. "We are continuing to monitor the situation," says Bradbard.
Meanwhile, Burke was not waiting for the FDA; she decided to utilize a legal route to remedy her situation. "I felt terribly betrayed," said Burke. "We are supposed to trust these people. I put my life in their hands and they could not even tell me what I was putting into my body that was making me terribly ill. They should make it so that it doesn't happen again. We should be able to trust who we get our medication from."
On January 31, 2001, San Diego attorney Frank Fox filed suit on behalf of Kelly Burke and another fake-drug victim named Robert Lynn. The suit named Serono Inc., Serostim's manufacturer, three distributors of the drug (McKesson Inc., Bergen Brunswig Corporation, and Cardinal Health), two pharmacy chains (CVS Procare, and Chronimed Holdings Inc.), and a host of John Does. Fox's suit charges that "Serono knew or should have known that a widespread black market had developed for Serostim...[and] that persons seeking to capitalize on the black market demand for Serostim would attempt to obtain and sell the real Serostim by substituting a counterfeit drug in the distribution chain." The suit further alleged that because Serono, the distributors, and pharmacies were the only "links in the chain of Serostim distribution ... they alone controlled the chain and procedures through which a counterfeit drug might enter the chain." Thus, contends the suit, they should be held ultimately responsible for allowing the counterfeit drug into the distribution network. Fox also alleged the companies did not take sufficient steps to warn or contact those who might be exposed to the fake substance. "The hoped-for resolution," said Fox, "is some measure of recovery for the pain and suffering and emotional distress that the plaintiffs experienced, as well as some change in the way that the defendants do business to make it, if not impossible, far less likely that this ever happens again."
Fox hoped to turn the case into a class action suit, but a San Diego Superior Court judge recently refused to certify the class. Nonetheless, the judge did rule the case could go ahead on most of the other consumer and product liability grounds, and while disappointed with the class action ruling, Fox is proceeding with the suit. "We will proceed on an individual basis. We have no intention of dismissing the suit."
For its part, Serono, while refusing to specifically comment on the suit, has indicated it has every intention of giving Fox a run for his money. "The main issue to focus on is that Serono didn't manufacture or distribute the counterfeit material," asserted corporate representative Carolyn Castel.
Castel stressed that the company has taken proactive steps to inform AIDS service organizations, pharmacies, and physicians of the counterfeiting problem. While it is undoubtedly true that warnings were sent, it does not appear that all the warnings made it to the intended parties. Berkeley's Health and Human Services Department, for example, only issued a warning on the subject after being contacted by a reporter.
(The CVS Procare pharmacy in Berkeley referred inquiries to the company's corporate offices in Providence, Rhode Island, where corporate spokesperson Todd Andrews declined comment on the suit. "We consider it a highly unusual incident because we are a large pharmaceutical company," stated Andrews. "We deal with large national wholesalers. It is unusual to encounter a counterfeit product." He added firmly, "I have confirmed that no further incidents have occurred.")
Despite the filing of the lawsuit, numerous articles and TV news stories, and the FDA investigation, there is little hard evidence for the method by which a potentially fatal counterfeit drug makes its way into the tightly regulated pharmaceutical supply chain. Most drug industry observers suspect that the counterfeit substances were made outside the United States, and probably got into the supply chain via a quasi-legal gray market.
While products in the nation's prescription drug market are supposed to be tracked from source to patient, there is a loophole in the regulations that allows drugs to be legally sold at a steep discount to hospitals and nursing homes which are then free to resell to drug distributors. The New York Times recently reported the case of a drug manufactured by Parke-Davis and sold to retail pharmacies for $73.75 while it sold the same drug to nursing homes for $38.18. Given this loophole in the law, a prescription drug purchased by a patient at a legitimate local pharmacy may have been resold so many times that it's simply not possible to determine its provenance. That means there can be breaks in the supply chain through which counterfeit drugs can sneak in.
Donald deKieffer, an expert in international trade regulation law at the Washington, DC firm of deKieffer and Horgan, is familiar with both Kelly Burke's lawsuit and the so-called diversion market. "They are going after the likely targets, but the real culprits in this case are unknown. You might be able to go after someone for negligence and go after the supply chain. But the people putting [fake drugs] into the distribution chain have false documents, false bills of lading, and a false paper trail. It is very difficult for anyone to know that a lot of the documents behind these transfers are forgeries. I have seen that happen in other cases."
"This gray market diversion is what allows counterfeits not only to exist but to flourish. And it allows the corruption or promotes the corruption of the legitimate distribution of these types of products," said the anonymous source familiar with the drug industry quoted previously. "The US drug supply is a hundred percent compromised by the diversion schemes. Congress and industry and the FDA all have their heads buried in the sand and they want to keep 'em there because it is a serious problem ... and there is no easy solution."
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