It takes only thirty minutes to make betamethasone the right way.
Heidi Medeiros should know. She’s made it enough times. One Friday last May, while working at Doc’s Pharmacy in Walnut Creek, the 31-year-old pharmacy technician received what seemed like her umpteenth request for a batch of the anti-inflammatory drug, phoned in by doctors from the nearby Sierra Surgery Center. The drug’s manufacturer, Schering-Plough Inc., had halted its production that February after the US Food and Drug Administration raised some manufacturing concerns, and local shortages were keeping Medeiros and her colleagues busy.
By that time, Medeiros knew the recipe by heart. She’d gotten her start as a clerk in a Thrifty pharmacy fresh out of high school, and later completed the company’s free training program to become a pharmacy technician. Despite the new title, she spent most of her time “counting and pushing, counting and pushing” endless streams of prescription pills. Over the next five years, the young woman got married, had two kids, and in 1997 landed a job at Doc’s, where she got to do the really fun stuff — drug compounding.
Only one percent of the nation’s pharmacies still formulates medications on-site, and Doc’s was Northern California’s most prolific drug compounder. Competition from drugstore chains and pharmaceutical manufacturers have made it tough for mom ‘n’ pop compounders to survive in a world where customers prefer their pills by the truckload. But at Doc’s, Medeiros enjoyed the pleasures of scratching out custom medicines for patients who needed a tweak on the standard two aspirins in the morning. For kids, she extracted the bitter taste out of penicillin and added cherry flavoring; she learned how to take the burn out of skin creams and make soothing gels for cancer patients, and to modify prescriptions for patients with deadly allergies.
She also learned how to whip up medications for hospitals in a pinch. After the shortage began, Medeiros found herself making betamethasone every week. She’d picked up most of her skills from watching Doc’s owner Bob Horwitz, a nationally renowned compounder. Horwitz was so adamant about his craft — “the art and science of compounding,” he called it — that he gladly taught anyone who was willing to learn. That included his young techs, whom the law allows to formulate medications so long as they are closely supervised by a licensed pharmacist.
Last May 11, Medeiros walked to the back of the store, pulled the ten ingredients for betamethasone from the shelves, and spread out her provisions beneath a sterile laminar hood. For this blend, sterility was crucial. Medeiros was making an injectable suspension that would be pumped directly into the patient’s bloodstream. “I was always careful and clean with everything I did,” she recalls. “And I always said, ‘If I wouldn’t take the drug myself, then I wouldn’t let anyone else take it.’ That was my standard.”
Medeiros made 300 milliliters of the milky suspension, enough to fill a grande-sized Starbucks coffee cup. The next step called for sterilizing the drug in an autoclave, but Doc’s didn’t own one. So, as she had done dozens of times before, Medeiros carried the jar to the outpatient clinic next door and made a neighborly deal with the receptionist: For the price of a Coke, she could use the autoclave.
After about fifteen minutes, the betamethasone jar was so hot that Medeiros needed a towel to protect her skin. Goods in hand, she returned to Doc’s, where she divided the drug into three sterile 100-milliliter jars, labeled her work, cleaned her workstation, and then, she says, headed straight home to begin a weeklong vacation as a cook at her daughter’s summer camp.
Within twelve days of her return, two people who’d been injected with the betamethasone were already dead.
George Stahl was a veteran UPS driver, six-foot-four and built, but over the years the job had worked him. The 47-year-old, whose pals affectionately called him “Pinhead,” had his first surgery in 1994 when doctors fused his lower spine, then again the next year to add more hardware to fix the first surgery. A few years later, his back was still hurting like hell, and the surgeon decided to pull all the metal out, leaving George with his original fusion. Still the pain shot down his long legs and up into his stomach, and he still couldn’t bend over. Returning to work seemed a distant dream.
At the suggestion of a pain-management therapist, the deliveryman went to see an orthopedic surgeon, Dr. Joseph Narloch, who prescribed a series of three betamethasone shots. The first shot was heaven. George’s rigid back loosened like he was a boy. He couldn’t wait for the next one. His wife, Marilyn Scully, drove him to the second appointment and again, George left reinvigorated. “If I can feel like this for a year,” he told her, “then maybe I can get back to work.”
Marilyn wasn’t available to drive her husband to the Sierra Surgery Center on May 29 for his third shot. She worked, and he’d signed up for a two o’clock slot. But a neighbor offered to shuttle George there and back.
The couple had a daily ritual. Normally, when Marilyn returned from work sometime between 6:30 and 7 p.m., George would come out to greet her in the kitchen. “On that day,” Marilyn says, “he wasn’t there.” Instead, she heard her husband calling from the bedroom, “Marilyn! Marilyn! This is it, Marilyn! This is it!” George came stalking down the hallway, wearing only gym shorts, gripping his head in his massive hands. He was screaming, which wasn’t like George at all.
He implored her to call Dr. Narloch, but it was after hours and no one picked up, so Marilyn called 911. George stretched out in the living-room recliner, still holding his head. He finally calmed, and his eyes narrowed to little slits, wishing the pain away. By the time the fire department and paramedics arrived, George was nearly unconscious. The medics laid their patient out on the gurney, strapped him in, and rushed to Mount Diablo Medical Center. Marilyn stayed behind to pack some shoes and a shirt. George was wearing only shorts, after all, and would need clothes for the trip home.
When she arrived at the hospital, her husband was inside a CAT scanner. A doctor soon returned with the results: blood spots were visible on George’s brain. Around midnight, the doctors transferred him to an intensive care unit at neighboring John Muir Medical Center. Family members arrived, two sisters and a brother — George was the youngest. An aneurysm, the doctor suggested. How else to account for the suddenness?
By early morning, it seemed to Marilyn that her husband was hooked up to every machine in the hospital. They were trying to get him to breathe better without the respirator. She waited anxiously. There’s no way George is going to die, she told herself. Come on. This is George. That afternoon, after what seemed an eternity, she found herself answering questions nobody wants to be asked: If we turn off the machines, would you like to donate organs? Yes, she answered in disbelief, George wanted to be a donor.
Marilyn experienced the rest of the day’s developments through a haze of shock and grief. An aneurysm? Wait. Now the harvesters are saying they can’t use George’s organs: something about an infection. They’re saying there are bacteria in his blood, in his urine, in his lungs, all over his body. The organs are no good now. George’s organs are no good.
My God, how did this happen?
Doc’s owner, Bob Horwitz, considers himself an eternal optimist. He grew up in San Francisco, a “nice little Jewish kid” who dreamed of becoming a doctor but never quite made it. As an undergraduate at Cal, he wasn’t able to pull the grades needed for medical school, but after some consideration, the young man concluded that a pharmacist with a knack for concocting medications could heal people just as well. “I fell in love with the idea and the ideology of compounding, hook, line, and sinker,” says Horwitz, now 61, his once-brown curls turned salt-and-pepper gray. “Still am.”
In the winter of 1965, just before graduating from the UCSF School of Pharmacy, Horwitz and his new wife Annette toured the Bay Area to hunt for a town where he could open his own drugstore. It was an era when pharmacists were still pharmacists, all white lab coats and Main Street smiles. Back then, local pharmacists concocted eighty percent of the drugs found in a customer’s medicine cabinet. But young Bob Horwitz had chosen a profession on the decline.
Ever since Congress passed the Federal Food, Drug, and Cosmetic Act of 1938, the FDA has required drug makers to put their new products through a stringent approval process. The legislation, which was intended to protect patients, also put the squeeze on local druggists. Although it exempted small-time compounders from the FDA approval process, only the largest companies could afford things like clinical trials. And, once products were approved, only the big fish had millions to spend promoting the new drugs. Who on Main Street could compete?
Many independent pharmacists called it quits, fearing lawsuits from customers or the FDA. Others sold out to chains like Thrifty and Walgreens. As brand names began popping up on more items in America’s medicine cabinets, the proportion of locally mixed drugs began to dwindle; it dropped to fifty percent, then thirty, then twenty, then five — compounding was on its way out.
Horwitz was successful nonetheless. By the early ’80s, he had already opened and sold off three pharmacies in Contra Costa County. In 1984, he opened another, which he named Doc’s, just across the street from John Muir Medical Center in Walnut Creek. It was the perfect location. For patients leaving the hospital, prescription in hand, it was the first drugstore they saw. And as clinics and specialists filled in around the growing facility, Horwitz’s rivals couldn’t get any closer to their customers than Doc’s.
Around that time, the pharmacist attended a convention where enthused colleagues spoke of the art of “customized medication.” Until then, his stores had mostly just filled prescriptions, compounding drugs sparingly on a must-have basis. But Horwitz left the convention again filled with the desire to heal. He took a three-day compounding course offered by the Professional Compounding Centers of America, the nation’s foremost seller of bulk drugs and compounding-related gear. Besides pharmacy schools, which offered a cursory sweep of the subject, the PCCA was the only place where a compounder could get certified.
One of his first serious compounding jobs was to extract the ingredients that caused nausea in a drug used by a chemotherapy patient, while maintaining the medication’s integrity. Successful, and feeling like he’d helped ease another human’s suffering, the pharmacist was hooked. “It opened a whole new world to me,” he recalls.
Horwitz began experimenting and learning more, all the while developing new techniques and establishing a national network of colleagues. The druggist began speaking at conventions and teaching classes at pharmacy schools, helping reinvigorate the case for compounding. He decorated his pharmacy to match his affable charm — he installed big aquariums at the counter stocked with fish, and just below those, a long horizontal shelf with flavor sticks for kids to choose from. From apple to tangerine, “Dr. Bob” could make medicine taste good.
Of all of his creations, Horwitz got the most pride from — and local recognition for — a moisturizer for breast cancer patients that prevented the skin from burning and flaking during radiation treatments. The cream was thick enough to soothe while still allowing radiation to penetrate. He dubbed his product “Doc’s TLC Cream” and had breast-cancer patients from all over the Bay Area asking their doctors for prescriptions.
Horwitz also conducted some of his own ad hoc clinical trials. At a surgeon’s request, he developed a cream that dissolved fatty tissue by merely rubbing it onto the skin. The cream served its medical purpose perfectly, but afterwards, Horwitz realized he’d invented a potentially lucrative vanity cream. One day an overweight customer lamented to the pharmacist how her weight triggered other health problems, and Horwitz had an idea. He gamely suggested she try his new cream, and told her to rub it on one forearm every day for three weeks. At the end of the trial, he says, the customer had lost three-quarters of an inch of fat around the arm. It ended there. “I wasn’t here to get rich quick,” he explains. “I was here for the public. I was here to help people.”
Dr. Alex Stalcup, medical director at the New Leaf Treatment Center in Concord, calls Horwitz the Bay Area’s premier compounder. Stalcup wanted to wean his clients off opiate-based painkillers while still providing something for their suffering. He’d heard that the FDA had approved such a drug, buprenorphine, which helps addicts kick their habits. But the European drug was stalled in the distribution process, and Stalcup needed a compounder to purchase it in bulk and compose it into a digestible form. Horwitz was able to style a gelatin cube injected with buprenorphine that dissolved quickly enough on the user’s tongue to be effective, yet not so quickly that it knocked the patient out.
Like many local doctors, Stalcup is effusive in his praise for Horwitz. “We’ve treated between two hundred and three hundred pain patients alone with his product,” he says, adding that pharmacists from Marin to San Jose now follow Horwitz’s protocol. “Without a doubt, he’s been the most reliable pharmacist in the Bay Area.”
In 1997, Horwitz received his profession’s highest honor when his brethren at the PCCA awarded him “Compounder of the Year.” But that same year, after largely ignoring compounding for five decades, the FDA was preparing to lay down the law. Even though there were no more than about two thousand compounders remaining in the United States, some had begun helping start-up companies mix large quantities of drugs to be sold over the Internet. The practice undercut manufacturers’ prices and skirted the FDA’s approval process, and legitimate compounders, worried the FDA would ban their craft altogether, helped government lawyers draft new laws that clarified the fine line between compounding and manufacturing.
The FDA Modernization Act of 1997 was clear: “Drugs must be compounded by a licensed pharmacist or physician in response to a valid prescription for an identified individual patient.” And even for those individual patients, they were to make drugs in “very limited quantities.” Of course, these compounded drugs weren’t for resale. The new law also required compounders to refrain from promoting the sale of any particular drug; by the FDA’s logic, such advertising created demand for drugs, and that wasn’t the compounder’s role.
Horwitz and most of his colleagues liked the new law. It gave them legitimacy, and protected their right to formulate drugs. But a group of compounders from Nevada quickly challenged it, arguing that the ad ban violated their First Amendment rights. The group was determined to take its case to the Supreme Court — and later did — leaving many compounders again fearful that the high court would somehow use the opportunity to ban their craft once and for all.
In the meantime, Doc’s was, by Horwitz’s belief, helping heal more people than ever before; it was selling about fifty prescriptions a day, half of which were compounded. By 1998, Horwitz was contemplating retirement, so he brought in a partner, a 32-year-old pharmacist named Jamey Sheets, and sold him a 49 percent stake. Sheets, accompanied by his wife Michelle and their two sons, had visited with Horwitz a few months earlier while conducting his own tour for a home pharmacy.
Although Horwitz taught his new partner the basics, he remained Doc’s undisputed compounding expert. The younger druggist’s strength was in retailing pharmacy products, and Horwitz preferred the lab. “I wasn’t good at selling soup, film, and beach towels,” he says. Sheets focused on front-of-house duties and introduced nutrition products to the store. His quiet, easy demeanor endeared him to the staff; within a few weeks he had all the techs munching vitamins right along with him. Fresh out of school, he also knew a few things Horwitz didn’t. According to many employees, the two complemented each other well. “I wanted him to be a better version of me,” recalls the elder pharmacist.
By last May, Doc’s founder was on the verge of cashing in. He had forty years in the business, two aching knees, and a shop in good hands. In preparation, he procured the paperwork needed to make his partner the official “pharmacist-in-charge.” Horwitz left the state forms in an office desk drawer for Sheets to fill out, he says. But the young man never got around to signing those papers.
On June 2, two days after George Stahl succumbed to infection by a common soil bacterium called Serratia marcescens, a patient named Raymond Bickerstaff died suddenly of the same illness. The next day, three more patients checked into John Muir Medical Center, all afflicted by the bacterial monster.
Investigators from the county health department were notified of the strange outbreak, and a quick check showed that all the patients had recently visited Dr. Narloch at the Surgery Center, and all had received betamethasone shots. Scanning through the orthopedist’s logs, investigators found that Narloch had administered 38 injections of betamethasone over the course of a week, and they scurried to track down those patients. The records also showed the drug’s point of origin: Doc’s Pharmacy.
On June 4, Horwitz called Dr. Wendel Brunner, public health director for Contra Costa Health Services. Sierra Surgery, he told Brunner, wasn’t his only client who’d received betamethasone. Diablo Valley Surgery Center in Concord and Diablo Orthopedic in Pittsburg had also purchased some of the medicine. Investigators quickly rounded up the unused vials, all of which tested positive for the bacteria.
Alerted by health officials, the patients rolled into John Muir. Five were admitted for bacterial meningitis, which, though painful, can be treated with antibiotics if diagnosed in time; eight others were hospitalized for lesser Serratia symptoms such as nausea and fatigue. The size and rarity of the outbreak astounded Brunner. “I don’t think anyone had ever been prepared for something like this,” he says.
The health authorities also descended on Doc’s Pharmacy. A county microbiologist named James McGee swabbed the compounding areas, around the sinks, under the laminar hood, and inside the autoclave located next door. Investigators from the California Board of Pharmacy and the FDA asked Medeiros to take them through the steps of her compounding. And the drugstore’s eleven employees — among them Horwitz, Sheets, Medeiros, and another technician named Nikki Cantrell — were corralled for questioning.
Slowly, a picture began to emerge. The larger 100ml batches of betamethasone were clear of bacteria, but someone at Doc’s had transferred portions into smaller vials for shipping. When the investigators learned how Doc’s employees made such transfers, their suspicions were aroused further. Horwitz had taught his techs to sterilize vials the way he learned to do it: by squirting alcohol into the vials and letting it dry.
Investigators left Doc’s believing that the vials were contaminated during the transfer process. Yet there was a missing link in the paper trail. State law requires compounding pharmacists to initial batches and sign off on each step of the drugmaking process. But Doc’s logs were incomplete — there was no way to know for certain which employee actually made the fateful transfer.
And no one stepped forward.
The national death toll from bad compounding practices is unknown and impossible to calculate. Indeed, L.D. King, executive director at the International Academy of Compounding Pharmacists, says he knows of only one other compounding-related fatality. The difficulty is that deaths from contaminated drugs can easily go unrecognized, especially when the patients are terminally ill; even with relatively healthy patients like George Stahl, the cause of death may be overlooked. “If it weren’t for the [organ] harvester we would have never known,” says Marilyn Scully, Stahl’s widow. “We would’ve buried him and called it a day.”
Paul Melodia, an attorney representing the Bickerstaff family and several other patients who fell ill from the injections, is suing the Sierra Surgery Center for failing to issue a sterile product. In such cases, the courts have historically ruled in favor of hospitals and doctors, reasoning that drug makers are responsible for their products.
Yet Melodia says his clients had a reasonable belief that the drugs were either FDA-approved, or at least compounded in the hospital’s own pharmacy. “They didn’t know their shots were coming from Doc’s Pharmacy,” Melodia says. “They had no idea where they came from.”
As it now stands, there’s nothing to prevent hospitals or clinics from purchasing drugs from compounders. Under California law, doctors aren’t supposed to stock more than a 72-hour supply of any drug. Yet when the hospital encounters a drug shortage — nebulously defined as when a doctor is unable to find a product — it is warranted to seek out a compounder. Nor is there any law on the books that requires doctors or hospitals to inform patients about the origin of the drugs being administered — most come from FDA-approved manufacturers, but some of the meds may be mixed on the fly by a poorly supervised pharmacy tech.
Soon after the Doc’s tragedy, Governor Gray Davis signed a bill by state senators Tom Torlakson and Liz Figueroa, authorizing the California Board of Pharmacy to create new licensing procedures for compounders who make sterile injectables like betamethasone. The International Association of Compounding Pharmacists has embraced the new law, and the pharmacy board, spurred to action by the Doc’s outbreak, expects to have the new procedures in place within a year. “Hopefully,” says King, the IACP director, “other states will follow California’s lead.”
While the new guidelines may well be in order, California doesn’t even have the resources to enforce its existing pharmacy laws. There are more than five thousand pharmacies in the state, but the pharmacy board has only nineteen inspectors to keep them in line. It’s a situation the board has long complained about.
Federal oversight no longer exists. Last month, when the Supreme Court ruled for the Nevada compounders in their free-speech case against the FDA, it struck down the entire federal provision regulating compounders, erasing all mention of the practice from US law books. “We’re back to square one,” says King.
This has mainstream compounders worried: Without a law that distinguishes them from manufacturers, that line could become blurred — real fast. “Pharmacists who were not inclined to go into the compounding business are probably more inclined to do so now,” says Marsha Cohen, a former pharmacy-board president who currently teaches food and drug law at Hastings Law School in San Francisco. “The pharmacy that thinks its niche in compounding is profitable will now greatly ramp up efforts to advertise, because we know advertising sells drugs. Is this bad? I think it’s risky. For one, I don’t like to see drugs out there that haven’t been tested for efficacy.”
And, with more and more compounders expected to jump into the game, it follows that hospitals and clinics will make more frequent use of their services. “The court,” Cohen says, “may have just planted the seeds to a public health care disaster.”
Lola Wright died on June 21, leaving behind a husband, four children, and nine grandchildren. The 82-year-old woman survived for twenty hellish days after her betamethasone shot. She was the third fatality connected to the bad batch from Doc’s.
Horwitz, meanwhile, was still coming to work every day, struggling to stay upbeat. The media had come down hard, pointing the blame where investigators said it fell: at Doc’s. He felt like he was suddenly taking the fall for an error, an unfortunate human mistake, in which he says he had little involvement. Suddenly the world had forgotten all of his hard work, all that he’d achieved, things like Doc’s TLC Cream. The first wrongful death lawsuit had already been filed against him.
The pharmacy board concluded its report and passed it to the state attorney general’s office, which scheduled disciplinary hearings to start just after Thanksgiving.
It seemed to Horwitz that the attorney general was out to get him from the start. The prosecutors had moved quickly, convincing an administrative law judge to suspend all compounding at Doc’s until after the hearings. The judge also ordered Horwitz to stay clear of Doc’s, and named Sheets pharmacist-in-charge. Horwitz was defiant. “They were making an example out of me and I was not going to take it,” he says. “Why should I?” Horwitz’s attorney persuaded the judge to let him at least work at the pharmacy, provided he stayed away from the drugs. Horwitz later sought an order that would have let him compound nonsterile drugs.
While employees awaited the hearings, the mood at Doc’s was absolutely funereal. Less than half of the usual business was coming in, and Horwitz had to let go six employees, more than half his staff. Sheets wasn’t communicating, Horwitz says. The young pharmacist was still showing up for work, still stocking his nutrition stands, but he wasn’t showing up in any other way. Nikki Cantrell, the other tech, was taking things hard, crying all the time, Medeiros says. And Medeiros was staying awake at night, replaying her steps, wondering if she could have done anything different that day. She took only a shred of solace, she says, in the knowledge that she hadn’t done the transfer — the step at which nearly everyone involved was now convinced the contamination had occurred.
On the eve of the hearings before State Administrative Law Judge Jonathan Lew, Horwitz surrendered his license to the pharmacy board. “They told me they were going to take it, or I was going to lose it. It would have been too expensive to fight,” he says bitterly. The choice did, however, spare him from the hearings, and could perhaps facilitate his return to the business in the future. The others — pharmacist Sheets and techs Medeiros and Cantrell — still stood accused of negligence under the California Business and Professions Code.
Stahl’s widow, Marilyn Scully, attended the Oakland hearings every day. Sheets’ wife sat by his side, and Medeiros and Cantrell listened quietly as Lloyd Paris, the assistant deputy attorney general, looked well beyond Doc’s tangerine-flavored elixirs.
State investigators testified that they found medicines at Doc’s that were missing labels, and others that had long since expired. They found employee lunches stored in refrigerators next to the medications — a sin in the industry. They found Serratia bacteria growing inside a homogenizer, in a sink drain board, and on faucet handles.
Poring through Doc’s logbooks, they also discovered that just a few weeks before the fateful batch was produced, Medeiros had fretted over the quality of the drug she was now making so frequently. The young tech knew Doc’s didn’t have the proper equipment, and was concerned about the drug’s potency.
The problem was the autoclave. Medeiros had prepared a batch of betamethasone that April that came out of the autoclave a burnt metallic color instead of milky white. According to the betamethasone formula log, or recipe, Medeiros was supposed to autoclave the drug for twenty minutes at precisely 115 degrees Celsius and a pressure of 15 PSI. But the instrument next door didn’t have manual controls — only four convenience settings. Since the recipe called for temperatures somewhere between the four choices, Medeiros fidgeted with the controls. The best she could do was to heat the suspension to 132 degrees at 27 PSI for fifteen minutes. That meant increasing the temperature and pressure, but decreasing the autoclaving time by a full five minutes.
Medeiros told investigators that she’d informed Horwitz of the autoclave problem, and that he agreed to call the Professional Compounding Centers of America to seek advice. Until then, Medeiros said, Horwitz instructed her to keep playing with the settings.
Records show that the tech was so concerned about the drug’s quality that she sent a test sample to Analytical Research Laboratories in Oklahoma City. The results were troubling: Two of the active ingredients, betamethasone sodium phosphate and betamethasone acetate, ranged from the labeled concentrations by 12 percent and 31 percent.
Standard practice allows for variation of up to five percent from the labeled amount, but this test batch was clearly subpotent. Sheets told investigators he spoke to Horwitz about the results, and that Horwitz, again, had promised to follow through with the PCCA. Horwitz disputes this version; he says Sheets never informed him, and that it was Sheets who approved the protocol change for Medeiros.
If that weren’t enough, investigators noted the instructions posted on the autoclave in bold type: “Not recommended for sterilization of liquids intended for direct patient contact.” There was a right way to make betamethasone, and there was a wrong way. But Doc’s continued to take orders, and Medeiros continued to fill them.
Prosecutor Paris also tried to get to the bottom of who made the final transfer, and how that person had come to consider squirted alcohol, or “cold sterilization,” an adequate way to sterilize injection-drug vials. Paris enlisted expert witness Joanne Whitney, director of the Drug Product Services Laboratory at UCSF, to testify that she was “shocked” that a pharmacist believed alcohol spray was a suitable sterilization technique for injectables. Since Horwitz wasn’t participating in the hearings, he couldn’t respond. But Sheets, Medeiros, and Cantrell all said they thought alcohol was an appropriate method, and all said Horwitz had told them so. Cold sterilization was the unquestioned standard procedure at Doc’s.
The board also chastised Doc’s for its paperwork. State law requires compounding pharmacists to supervise the work of their technicians and sign off on it. But Doc’s logs were hopeless. Some were signed, some weren’t. Rather than initialing each at each step as state law requires, the supervising pharmacists would often initial once at the top and draw a long arrow down the column; other logs had “N/A” in areas that called for a supervisor’s initials.
Prior to the hearings, Sheets wrote a letter to the pharmacy board saying that he’d purposely sought out Horwitz to learn the business from one of the best, but had since come to learn that the renowned compounder was growing lazy in his twilight years. The compounding, he wrote, was mainly Horwitz’s realm. “I foolishly was led to believe that Doc’s Pharmacy, being such a well-respected pharmacy and Dr. Horwitz being so well-revered by his colleagues, was following all practices to the letter of the law,” Sheets wrote. (Horwitz, despite his nickname, was never a physician.)
It was unclear who was in charge on the day Medeiros mixed the betamethasone. She says she doesn’t recall who was on duty, but the records suggest Sheets was out of the office, leaving only Horwitz available. The date that the drug was transferred to the smaller vials was ambiguous in the logs — even the date the drug was made had been recorded improperly.
Sheets denied he was present when the betamethasone in question was made or transferred. He wrote the board that he was prepared to “take some responsibility,” but added that he couldn’t be “directly blamed for something that I was not even at the pharmacy when it happened.”
Judge Lew and the Pharmacy Board saw things differently. Sheets’ license was suspended for ninety days, as were those of Medeiros and Cantrell, and all were prohibited from compounding drugs for five years. The board commended Medeiros, however, for sending the test batch out to Oklahoma, and reassured Cantrell, even though her role appeared to be minimal, that she’d only been following the instructions of her superiors. But the panel was particularly harsh on Sheets, who, as a supervisor, was expected to bear some of the burden. In its investigation summary, members wrote, “The respondent just doesn’t get it. … He must accept more than token responsibility for what happened and not be so quick to lay blame at the feet of Horwitz.”Soon after the hearings, Horwitz sold Doc’s Pharmacy. Since he owned a majority, he didn’t bother to inform Sheets of the sale. The two pharmacists had stopped talking, Horwitz says. “He didn’t call me once during this whole thing. Jamey was not good at talking about this. Was I angry that he didn’t call me? Yes.”
Horwitz returned briefly to work for the new owner, who figured “Dr. Bob” still commanded a loyal clientele, and Sheets found work counting pills at a Walnut Creek Safeway. Tech Nikki Cantrell landed a job at the same Safeway; former Doc’s employees say the two were close and that it was no surprise they ended up working together again.
But Sheets was furious with Horwitz. Supporting his family on a Safeway salary was difficult enough, but losing out on the chance to own Doc’s outright and one day retire in comfort, as Horwitz was preparing to do, was too much. As the lawsuits began piling up, Sheets slumped into despair. On March 26, Sheets’ wife Michelle and their two sons returned to their Pleasant Hill home from a trip to her parents’ place in Oceanside. Sheets was depressed about his impending suspension, Michelle later told police, and had decided to stay home alone.
She found her husband’s body in their bedroom blotted with six patches of fentanyl, a morphine-based painkiller often used on terminally ill cancer patients. The patch is supposed to dissolve the drug slowly over two or three days, but the young pharmacist had grated his skin with a razor to absorb the dosage more quickly. A can of beer was found near the bed, but Sheets left no note.
They can only wonder now. Heidi Medeiros wonders if Jamey Sheets kept secrets. “He must have known something more, or else why would he do this to himself?” she says. “Why wouldn’t he leave a note?”
Medeiros has her theories. They all do. She claims that one late night several months ago, her colleague Nikki had bared her soul to Medeiros and sobbed out a confession. “We were talking, and she was crying hard,” Medeiros says. “I said, ‘How do you think I feel? I’m the one who made it.’ And she said, ‘How do you think I feel? I’m the one who transferred it.’ “
Cantrell, who did not respond to repeated interview requests for this article, has denied to investigators that she made the transfer. She told others who worked at the pharmacy that she thinks Bob Horwitz may have been the culprit. Horwitz, meanwhile, suggests that Sheets was responsible. “In my mind, it was either Jamey or Nikki,” he says.
There will be more finger-pointing to come as lawyers behind the mountain of lawsuits that seemed to bedevil Sheets seek out targets for liability. Fifteen suits have been filed in Contra Costa County Superior Court so far, all naming Horwitz as a defendant. Three also named Sheets, pointing to his ultimate responsibility as a supervising pharmacist. “You can only imagine what was going through his head,” Horwitz now says. “There are several ways to deal with this situation, and Jamey opted out of the situation altogether.” He takes a breath. “That was how Jamey handled it. Although one certainly considers it when all the bad things keep stacking up on top of the other.”
In a few weeks, Bob Horwitz plans to undergo surgery on both of his bad knees simultaneously. It’s rare for surgeons to operate on two legs at once, but Horwitz’s joints and ligaments have betrayed him so severely that he can wait no longer. “I’ve got this joint going this way,” he says, balling up a fist and tucking it beneath his other hand to describe the grinding friction, “and it’s pressing up against another thing going this way.”
After being out of work for almost a year, Horwitz claims he’s facing financial ruin. It’s a tragedy that people have died, he says, and the weight of being associated with these deaths is on his shoulders: “You wake up, and you think it can’t get any worse. And then something happens that day and it does. Every day something else happens, and you can’t really believe it.”
People in Walnut Creek used to stop him in the street or wave hello to “Dr. Bob.” And some still do, especially those who’ve supported him and his family. “You can imagine how my wife and family feel, going through all this,” he says, shaking his head. “They are truly victims in all of this.”
But Horwitz still feels that he was coerced into giving up his license, that he had no choice. And he still proudly defends his products and lab protocol. He says the cold-sterilization technique he taught is perfectly legitimate. If the contamination occurred at Doc’s, he says, it was most likely from a lab tech’s dirty hands or coat sleeve, not the vials themselves.
His sales to hospitals and clinics weren’t for gratuitous profit, Horwitz says, but always to service the public need. The doctors came to him, he says; he never sold more then was asked, and never lapsed into manufacturing. “In no way did we circumvent the law and go beyond the law, or how it’s indicated,” says the pharmacist.
Looking back to the formula logs and the unsanctioned autoclave equipment, Horwitz insists it was Sheets who told Medeiros to change the protocol. “In an attempt to fix that, my partner opted to alter protocol, unbeknownst to me,” he says. “I never handled that drug at all.”
In fact, he says, had Sheets completed his paperwork making him pharmacist-in-charge, the elder pharmacist wouldn’t even be tangled in this mess. “None of this would be coming down on me,” says Horwitz. “But I was the one with the reputation. I was the one they could take down.”
He’s considering, down the road perhaps, a fight to regain his license. But first, he’s got to deal with all the lawsuits and relive the whole nightmare. His blood pressure is through the roof, and he’s not getting around too well these days.
And the embattled pharmacist knows his upcoming surgery will require a variety of drugs. Anti-inflammatories like betamethasone are certain. Painkillers a must. Injections, absolutely. Yet where they’ll come from, or how they’ll be made, Dr. Bob can’t be totally sure. He says he’ll leave it in the hands of his doctor.
Bob Horwitz, for one, isn’t afraid to try a taste of his own medicine.