After practicing emergency medicine for thirty years, Chuck Phillips wasn't surprised by much. Blood, guts, trauma, maimings -- whatever wandered into his Fresno emergency room, he was ready. The doctor teaches courses on treating trauma victims and has written the book, literally, on paramedic skills. But in early 1999, as dozens of senior citizens streamed into the ER of the Kaiser Permanente hospital where he worked, Phillips found himself shocked by what was happening.
Some patients complained of problems related to their high blood pressure, others of dizziness and chest pains; still others had suffered strokes, heart attacks, or kidney trouble. What didn't make sense to Phillips was that many of them were already taking pills for high blood pressure. It seemed to him that their medications should have kept many of these disorders in check. He was perplexed.
A hands-on, old-school doctor, Phillips began asking questions, and, in response to his probing, the patients showed him their medications. Something was very wrong. In the bags and boxes they displayed, Phillips found pills broken into fragments or even reduced to dust. Studying the labels, he noticed that the prescribed dosages were abnormally high. In cases where, for instance, ten milligrams was the appropriate dosage, the pills were prescribed in twenty-milligram doses with labels that read "Take one half daily." Patient after patient explained that Kaiser pharmacists had told them to cut their tablets in half. Some had been given small devices for cutting their pills, but others just did it by hand.
"The pills were just ruined," Phillips explains. "In thirty years of practicing medicine, I'd never seen anything like this."
Phillips concluded that his patients were taking wildly variable doses of medication for their high blood pressure because pills usually split unevenly, with portions often crumbling or even breaking apart into powder. This, he believed, was the cause of their health problems.
To see if he could figure out what was going on, the doctor wrote himself a prescription for twenty milligrams of lisinopril, a drug he takes for his own high blood pressure, and took it to the Kaiser pharmacy in his own neighborhood. Sure enough, when he picked his pills up, the dosage had been doubled. The pharmacist handed the medication to Phillips along with a pill-splitter -- a small plastic box containing a razor blade and a soft piece of plastic designed to hold the medication in place while it was cut in half.
"I said to the pharmacist, 'I didn't write it this way,' and he said, 'Well, this is the way it is.' Then I asked where was his authority to do this, and he copied me a page of protocols from the Kaiser main office."
The protocols spelled out six medications for high blood pressure, elevated cholesterol, and migraine that were to be prescribed in double doses and split in half by Kaiser patients. Lisinopril was on the list. But the policy also stated that the practice was voluntary for both the patients and doctors, and Phillips soon found that this wasn't the case. Despite his protests, he couldn't get the pharmacist to give him the twenty-milligram dosage he'd prescribed for himself. The doctor was steamed.
"This was bad medicine and had to stop," he says. "Kaiser says this is to keep the cost of medicine down, but if it's bad medicine, what's the point of keeping costs down?"
Some doctors might have written off the matter as just another maddening rule from the world of managed health care. But acquiescence wasn't Phillips' style. He was a rabble-rouser with a big mouth, the son of a crusading dentist who had treated the poor in Africa and tended to Mahatma Gandhi's teeth. Phillips was someone who wouldn't hesitate to call the state medical board to complain about something if he felt strongly enough about it -- which, in fact, he had done recently when one of his Hmong patients was left untreated at another Fresno emergency room.
The contract doctor certainly had motivation to take on Kaiser. Phillips also had a complaint pending with the federal Equal Employment Opportunity Commission over Kaiser's practice of paying young physician recruits 10 percent more than those with more experience. After he filed that complaint in 1999, Kaiser changed its policy, although a company spokeswoman told The Wall Street Journal that the doctor's complaint was not the reason for the revision. When Phillips' contract lapsed in mid-1999, Kaiser did not hire him again. He says he took on pill-splitting, like the age discrimination issue, because he thought it was wrong.
Phillips began campaigning to end Kaiser's scheme. His efforts ultimately stoked a growing, nationwide controversy over the practice -- one that pits leaders of the managed-care industry against the National Association of Boards of Pharmacy and the American Medical Association. Opponents of pill-splitting contend the issue is whether there are limits on how far health-care companies can go in their quest to save money. Meanwhile, health-maintenance organizations across the country are watching the dispute closely as they consider whether to implement their own pill-splitting programs.
Pill-splitting probably would have no advocates at all if not for the seemingly odd way in which the pharmaceutical industry prices its products. Pill makers typically charge roughly the same amount of money for any size dosage of a medication. There are two primary reasons, according to Dr. Randall Stafford, a researcher at Stanford's Center for Research in Disease Prevention. Larger doses don't cost much more to produce (and research and development expenses are actually far more relevant to the final price of a drug than the cost of its raw ingredients). And perhaps more importantly, image-conscious pharmaceutical companies don't want to be seen as profiting most from those unfortunate patients who happen to need stronger doses of their drugs.
Whatever the reasons behind these pricing strategies, the result is that the cost savings from pill-splitting can be phenomenal for organizations that purchase and then resell medication in large volumes. For instance, officials at Kaiser appear to have realized in the '90s that they could save millions of dollars a year on drug costs simply by buying double dosages of a handful of drugs and then having patients split their tablets in half. Kaiser's California director of drug-use management, Matt Nye, told USA Today in 1999 that splitting the cholesterol-lowering drug lisinopril saves the firm $4 million to $5 million a year in California alone. Nationwide, he estimated, pill-splitting saved Kaiser $40 million to $50 million per year.
At a time when skyrocketing pharmaceutical bills are driving health-care bills upward by an estimated 15 percent a year, some academics endorse this practice as an effective way to help rein in such costs. "When properly implemented, pill-splitting can be a safe, viable, and cost-saving strategy," says Stafford, author of a study on pill-splitting published recently in the American Journal of Managed Care. "Physicians should consider using pill-splitting with selected medications and patients, and patients may want to bring it up with their doctors." Stafford's study suggests that health-care providers accrue the bulk of the savings, however; patients typically save only about $1 a month.
Kaiser officials insist that their approach to the practice is completely safe and entirely voluntary. As Phillips discovered that day at his local pharmacy, the HMO's literature theoretically limits the practice to six approved drugs and says that splitting pills is a choice, not a mandate, for both doctors and patients. "Kaiser Permanente implements tablet-splitting programs in a safe and beneficial manner, maintaining or improving the quality of care our patients receive while helping to mitigate rapidly escalating drug costs," a company statement says.
However, Phillips insists that his own research into Kaiser's operating procedures uncovered another 31 types of pills that were being broken in half -- often by patients with epilepsy, emphysema, heart ailments, or other disorders.
Phillips is an unlikely hell-raiser. He's a sixty-year-old father of seven who occasionally donates his services to low-income Laotians in his community. But the blue-eyed doctor definitely has the crusader in him.
Once Phillips thought he had figured out Kaiser's pill-splitting scheme, which appeared to be mandatory for doctors, pharmacists, and patients, he started what could only be called a crusade. He decided the best way to make noise was to go over the head of Kaiser, so he got in touch with the American Medical Association, the California Medical Board, and the California Consumer Health Care Council. He also contacted the federal Food and Drug Administration and Department of Health and Human Services.
Phillips found an ally in John Metz, chairman of the California Consumer Health Care Council in San Francisco. "At first I was like, 'What's the big deal?'" Metz recalls. "Then I listened some more and it became clear to me that there was something very rotten going on." After hearing Phillips out and learning more about the issue, Metz signed up to help the doctor take on Kaiser. Together, the two men started collecting stories and evidence about pill-splitting directly from patients.
All across California, they found Kaiser members who were breaking pills in two. Most shocking were the cases of very ill elderly people who were breaking their medications in half. For instance, Pittsburg's Winston Yarborough told them he was forced to split his lisinopril pills despite suffering from essential tremor disorder, a disease that makes his hands and body shake.
"I went to the Kaiser pharmacy and they gave me my pills and said I had to cut them in half," says the 67-year-old Yarborough, who also suffers from diabetes and asthma. "I really didn't want to do it, but the pharmacist said I had to. ... I was shaking when I had to split the pills and it was really hard and there wasn't anybody around to help."
The retired warehouseman says that since his pills crumbled into small particles when he split them, he would eat a bunch of broken pieces in an effort to get the proper dosage. It didn't always work. "I got sick from not taking the right doses," he says, although he cannot recall exactly how the broken medications affected his health.
Metz and Phillips also heard the story of Mary Cargile, a 74-year-old Aptos resident who suffers from high blood pressure and essential tremor disease. She was given a prescription for Diamox, a medication she takes to help control her tremors and, ironically, told to split the pill that was supposed to stop her shaking.
At first, she thought nothing of the pharmacist's instructions. She says she was thrilled to get a new drug that just might help. "I was desperate to have something to control the shaking so I didn't complain," says Cargile, whose tremor disorder makes it impossible for her to drive and a struggle to even hold utensils. "When I got to the pharmacy, they gave me a splitter and didn't talk to me about it, and I was too stupid to ask any questions. I had to have friends help me split the pills because I live alone."
Metz and Phillips were shocked by what they were hearing. "Asking somebody with essential tremor disease to split pills is like the theater of the absurd," Metz says.
Some Kaiser patients said they were told the policy was mandatory, and they'd been unable to get the proper dosage of their meds despite complaints. Others failed to challenge the practice because they assumed they were required to cut their tablets in half. Still others were unaware that they could get the dosages they needed straight from the bottle.
Livermore's Charles Folker, a retired engineer and Kaiser member, says his complaints about not wanting to split his cholesterol-lowering medication went nowhere. "There was no arguing with the pharmacist and there was no way to get out of it," he says. "When I complained, I was told that was the way they do it at Kaiser."
Eventually, Metz and Phillips convinced Trial Lawyers for Public Justice, a nonprofit public-interest law firm with an office in Oakland, to file a class-action suit against Kaiser, the oldest and largest HMO in the country. Phillips, Metz, Yarborough, Cargile, and other Kaiser patients around the state signed on as plaintiffs.
"It seemed to us that this was a clear example of an HMO putting money before its patients' health, because there was no medical justification for the policy and it was clear cost-cutting," recalls Victoria Ni, one of the lead attorneys on the case. "Our position is there have been no studies to determine the health effects of splitting tablets and the onus shouldn't be on the consumers to establish health risks."
In December of 2000, Trial Lawyers for Public Justice filed a class-action lawsuit against Kaiser Permanente in Alameda County Superior Court. Other lawyers around the country signed on to help the group litigate its case. "It is hard to imagine a more blatant consumer fraud," wrote fellow plaintiff's attorney Sharon Arkin of Newport Beach in a press release announcing the case. "And it is particularly disturbing that Kaiser is endangering those who need its help most -- the elderly, frail, and sick."
Although the lawyers believed Kaiser's policy was neither safe nor voluntary, they ultimately concluded they couldn't directly challenge the medical merits of the practice. After all, definitively proving that pill-splitting had led to adverse health impacts would be difficult, since all the patients involved in the case were already sick -- sometimes seriously. And Phillips and Metz hadn't turned up any cases in which patients had been gravely injured or killed by the practice. They hoped the lawsuit would ensure that no Kaiser member ever would be seriously sickened by taking an improper dose of medication. "I get nothing financially from this lawsuit," Phillips says. "We're simply out to change the policy. I've lost time and money on this."
Lacking clients who could definitely prove that their illnesses were made worse by pill-splitting, Ni and her colleagues were forced instead to challenge Kaiser on regulatory and legal grounds, two of which sounded mostly like procedural technicalities. The most substantive of the three claims was their contention that Kaiser's medication scheme undermined the policy of the federal Food and Drug Administration, which carefully regulates the size, shape, and quality of prescription drugs. "In pill-splitting, the very medication is being altered," Arkin observes. "The FDA establishes standards for a reason. Who the hell is Kaiser to decide they know better than the FDA?"
A second allegation claimed that Kaiser's pill-splitting program violated a state consumer-protection law, which requires companies to deliver on the promises they make to customers in their promotional literature. Since Kaiser promoted itself as an organization that put patients first and offered the highest quality care, the lawsuit alleged that the program clearly broke those promises and therefore breached state law.
Finally, the suit alleged that the plan violated the medical providers' standard of care in California, which requires firms to disclose any financial interests they have in health-care decisions. Because Kaiser profits from pill-splitting, the lawsuit contended that the firm was required to reveal that to its patients. "Kaiser should be disclosing to its patients that its bottom line is improved if the client splits pills, but they're not doing that," Ni says. "That's why it's unlawful."
Two years into the lawsuit, the debate over pill-splitting is louder than ever. But even as the debate raged on, the lawsuit was thrown out of court last week by a Superior Court judge in Alameda County, who ruled that his court was the wrong venue.
"It is a bad day for consumers," Metz laments. "What this pill-splitting amounts to is one of the largest, uncontrolled medical experiments in the history of the United States that is being conducted, near as I can tell, primarily to make health insurance companies money."
Because pill-splitting was the subject of a legal challenge, Kaiser officials declined to be interviewed for this story. But in an official written statement, HMO officials defended the practice and pointed out they are not alone in embracing it. Kaiser insists that any savings from pill-splitting is reinvested in patient care and that the practice is safe, supported by research, and has been praised by national consumer groups as an effective strategy for ensuring medications are affordable.
"At Kaiser Permanente, decisions about the safety and appropriateness of tablet-splitting are made by physicians and pharmacists," the statement says. "The safety and benefit of tablet-splitting has been demonstrated by research. It is supported by national consumer groups as an effective strategy to make drugs more affordable, and a number of government-sponsored health-care programs -- including several state Medicaid programs and Veterans Administration centers -- have adopted tablet-splitting."
Indeed, Kaiser is certainly not the only health-care firm to implement pill-splitting. Federal and state agencies around the country are experimenting with the practice, as are other health maintenance organizations. But Ni says the Oakland-based firm is "by far the most aggressive" in implementing the cost-saving strategy.
Susan Pisano, a spokeswoman for the American Association of Health Plans based in Washington, DC, notes that her industry is exploring the program on a very limited basis. "It's not the kind of thing that works for many medications," she says. "There are only some medications for which pill-splitting would be appropriate. It's part of an overall strategy that's designed on behalf of people in managed-care plans to keep the prescription drug benefit safe, comprehensive, and affordable.
Embrace of the practice by one large Nevada HMO, which required doctors and patients to break certain costly tablets in half even though the drugs' manufacturers recommended against it, called pill-splitting to the attention of the American Medical Association.
"If insurance plans or anybody else is mandating pill-splitting, it could be very dangerous," says AMA chairman Dr. Edward Hill. "Medications for lung disease and heart problems have a narrow therapeutic window, and what that means is a small change in the dose could have a profound effect on the patient -- possibly killing someone."
As Hill sees it, doctors should retain the final authority to ensure that tablet-splitting is safe and entirely voluntary for everyone involved. "I don't care who mandates it; a physician's ethical responsibility should override that," he says.
Although the AMA was not directly involved in the suit against Kaiser, when Hill was informed about some of the allegations in the case and Kaiser's defense of its tablet-splitting plan, he said, "Somebody is going to have to bring some facts to the court to prove their point."
But the decision by Alameda County Superior Court Judge Ronald Sabraw to dismiss the lawsuit before it even went to trial suggests that the day of reckoning could be a long way off. Sabraw's final ruling concluded that while the courts are "well-suited to determine whether Kaiser has breached a duty to an individual consumer and caused injury to that consumer," the courtroom is not an appropriate venue to determine "whether an HMO's policies provide adequate care for its consumers."
Scientific inquiries into pill-splitting can be divided into two broad categories: how tablets fare once they are broken apart, and how altering such medications affects patient health. Although no research conclusively points to specific patients who have suffered adverse health effects, some studies conclude that the practice poses increased health risks.
A substantial body of research suggests that pill-splitting is more art than science. In a study of eleven commonly split tablets published in the Journal of the American Pharmaceutical Association, scientists found that eight of the medications routinely failed to yield uniform half-dosages once divided. The dosages were not uniform because of uneven splits or crumbling. Whether the tablet was scored or not made little difference. The person who did the splitting for the research was a 25-year-old pharmacy student who had been specially trained to split tablets with a razor blade. Three tablets split exclusively by hand yielded even worse results than those split with a razor.
In a study on the accuracy of pill-splitting in healthy adults published in the journal Drug Use Insights, researchers found manually broken tablets varied in size by up to 40 percent. Use of a pill-splitter, researchers noted, did not improve the accuracy of splitting. The study's authors hypothesized that such variations "could be clinically relevant" -- or, in other words, make people sick.
Another study, in The Annals of Pharmocotherapy, found that 21 percent of patients surveyed forgot to take their broken-tablet doses more frequently than whole-pill dosages. Still another study, in the American Journal of Hospital Pharmacy, identified several other tablets that, when split, resulted in half-tablets with dosages that varied more than 15 percent from the desired half-dosage.
But research into the actual health effects of these variations is far less clear-cut. Scientists have uncovered health risks when patients split at least one cholesterol-lowering medication, which is on the Kaiser list of accepted medications for tablet-splitting. In the Annals of Pharmocotherapy study, researchers found that patients who split their tablets of simvastatin, which is sold under the brand name Zocor, experienced up to an 18 percent increase in cardiac risk. Yet in the specific patients in this study, researchers conceded that half-tablet therapy appeared to have been as effective as a single dose.
"That study shows there is a serious problem," attorney Ni says. "Kaiser has decided 18 percent risk is acceptable for their membership. I don't think any Kaiser patients are being told of that increased risk."
Stafford's analysis of pill-splitting for Stanford's Center for Research in Drug Prevention looked at 265 different medications and determined that eleven were good candidates. Many of the other 254 medications were knocked off the list because they were capsules or other forms of medication that could not be split by the average patient. Others were not considered because they treated illnesses in which dose variations could have a serious health impact. Although Stafford's study endorsed the practice, it cautioned that pill-splitting should only be implemented with "careful controls" and only with "selected medications and patients."
"The cost savings from this underused practice are significant and, if implemented judiciously, this strategy presents an opportunity to reduce health-care costs without compromising quality," Stafford says. "Health-care expenditures have increased tremendously in the last decade, particularly in the area of prescription drugs, which have risen 15 percent a year in recent years."
Most medications have yet to be tested for their safety in half-dosages. And the lawyers suing Kaiser argue that its members should not be put in the role of guinea pigs to determine whether the health risks are acceptable.
As if matters weren't already confusing enough, last year a study by the federal Department of Veterans' Affairs reviewed the available research on pill-splitting and concluded that no evidence existed that the practice was harmful to patients. Nonetheless, the agency decided not to recommend it.
As to which patients might safely split pills, professional organizations such as the American Medical Association and the American Society of Consultant Pharmacists strongly oppose pill-splitting for seniors who have any kind of functional impairment that may limit their ability to break a tablet in two. Anyone with arthritis, cognitive or visual problems, Parkinson's disease, or other tremor disorders should not split pills, the pharmaceutical group says. "These limitations may result in patients missing doses of the medication, discontinuing therapy without knowledge of the prescriber, or sometimes receiving excessive doses of the medication," a society policy says.
The society concluded that the practice has many risks, especially for elderly patients in the United States, nearly 50 percent of whom suffer from arthritis. Like the AMA, the society issued a statement "strongly opposing" mandatory pill-splitting. In one paper on the practice, the organization quoted Daniel A. Hussar, a professor of pharmacy at the Philadelphia College of Pharmacy, who concluded that, "Tablet-splitting for economic reasons is bad patient care and bad pharmacy practice."
Phillips and the other plaintiffs in the lawsuit say Kaiser clearly failed to follow the consultant pharmacy organization's guidelines about which patients should not split pills.
In his tentative decision dismissing the lawsuit, Judge Sabraw says the plaintiffs' argument that pill-splitting violates FDA policy is wrong because there is no statute or FDA regulation prohibiting the practice. "Indeed, despite all the state and federal statutes and regulations regarding health services there is no explicit proscription against pill-splitting," the judge wrote. "In the absence of a clear legislative or regulatory mandate, the court is reluctant to infer that pill- splitting is prohibited."
As to whether the pill-splitting scheme violated the state's standard for medical care, the judge wrote that, to prove that a medical practice falls below that threshold, plaintiffs must show there is a "reasonable medical probability" that it causes physical injury. Expert testimony merely suggesting that the policy is "inappropriate and unwise" does not pass legal muster, Sabraw ruled.
And on the assertion that pill-splitting violated state consumer-protection laws, Sabraw wrote, "There is no substantial evidence that Kaiser requires pill-splitting of drugs that are not on its approved list or that any consumer has been injured by having to split pills." Despite the wealth of available testimony from patients such as Yarborough, Cargile, and others, Sabraw ruled that such anecdotal evidence is insufficient for challenging a company's business practices.
Ni says the decision will be appealed. "The evidence demonstrates that the 'written' policy is nothing more than a showpiece that has nothing to do with the reality that Kaiser patients face," she and her colleagues wrote in a memorandum challenging the judge's tentative dismissal.
Phillips, however, says his mission is not tied up with the lawsuit's fate. Whatever happens with the case, he won't back down. "Kaiser promises patients good medications and excellent medicine," he says. "What they give to their members is wrecked medications. I consider stopping pill-splitting is like chasing the money changers out of the temples of healing."
In his final ruling last week, Sabraw reaffirmed that it was not the court's jurisdiction to help fashion an HMO's policy. Oversight of that type is the responsibility of the state Legislature or California's Department of Managed Care, he reasoned. "The courts are not well-suited to determine, in the abstract, whether an HMO's policies provide adequate care for its consumers," he wrote.
But Phillips is not about to back down, even if the courts reject his cause.
"In paramedic systems, which I've set up, it often takes the death of someone prominent to make the system improve," he says. "We thought with this suit we could try to avoid harm by pointing out what is clearly bad care. Maybe we have to see the harm spelled out before we can put an end to it."
Phillips hopes he doesn't see that day come. But if it does, he promises it won't go unnoticed.
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