Her uterus is intact: An alternative to hysterectomy

Shelly is an Iowa native and a 42-year-old mother of two daughters. She trained to be a schoolteacher and later worked as a pharmaceutical representative. She is savvy and understands the business of health care. Her Ob-Gyn in a three-physician office practice in her hometown diagnosed uterine fibroids. The doctor told her that her only option was a laparoscopic hysterectomy.

Shelly describes what happened next. "I didn't want a hysterectomy, so I asked about less invasive methods that would leave my uterus intact and get rid of the fibroids. The doctor made fun of me, repeating 'less invasive methods' mockingly. Then she said, 'When that fibroid grows up over your belly button, you'll come running back!' I asked her whether my ovaries and cervix would remain, and she said, 'Well, I guess we could leave them." Shelly was indignant that anyone would remove perfectly healthy organs. She thought to herself, "my ovaries and cervix are perfectly fine!"

Not satisfied, Shelly saw another doctor in the practice who came to the same conclusion. Laparoscopic hysterectomy. So did the third doctor in the same practice.

"I wanted them to know that I'm not the average cabbage that fell out of the truck, so I asked for a copy of my medical records and the ultrasound so I could search for less drastic alternatives. They said, 'We only give records to our obstetric patients.' I was floored." Shelly knows that patients have a right to a copy of their medical records. When she called her insurance company to find out how the doctor's office could withhold her medical records, the company representative put her in touch with the state medical licensing board, which gives doctors their licenses to practice medicine. Shelly spoke to a representative of the licensing board. "I don't know what this person did," she says, "but within a day I had my records."

In the records she saw that the second doctor had written that she spent 45 minutes discussing treatment alternatives to laparoscopic hysterectomy. "That was a lie," Shelly says. "She spent 10 to 15 minutes with me and didn't tell me about my options. That's because it would be money out of their pocket if I chose an alternative treatment that these doctors didn't do. All they did was laparoscopic hysterectomies, so that's what they recommended. I think it's a conflict of interest for them to steer people toward certain procedures because that's what they know and that's how they make money."

Shelly thoroughly researched treatment options and found a less drastic alternative that she believed was best for her. Her uterus is intact, and she is pleased with the results. "It's not enough for patients to know treatment options and their risks and benefits," she says. "You have to understand the business of health care." Because Shelly had worked in health care, she understood that she was led down a treatment path that might be good for the doctor's business but not for her. When asked what happens to people who don't have the skills she has, she quips, "They will have everything ripped out."

Advice: Be aware of physicians' financial incentives.

Read a story about unnecessary treatment. Thanks to Rosemary Gibson for this story, reprinted from her excellent new book, co-authored with Janardan Prasad Singh: The Treatment Trap: how the overuse of medical care is wrecking your health and what you can do to prevent it.
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Don't back down on disclosure: Drug companies' payments to doctors

The Boston Globe published an editorial yesterday encouraging the Massachusetts Department of Public Health to stand firm in its regulations that limit the gifts and money that drug companies give to doctors.

Calvin Timberlake would probably agree. Calvin’s story appeared in this blog here. His surgeon had invested in the manufacturer of Prodisc, and he chose to install a Prodisc in Calvin's spine to relieve his lower back pain. The Prodisc later came apart, requiring an immediate operation to remove it, and leaving Calvin permanently in pain. The surgeons who had written the medical journal articles that persuaded the FDA to approve the device had large investments in its manufacturer.

Doctors should disclose their investments to medical journal editors and to their patients, and state government regulators should insist they do so.

Advice: Ask the officials in your state government’s public health department to require disclosure of funds that doctors receive for all purposes other than direct medical care, including everything from pens and pads of paper to research funding.

Our hearts go out to them: Bias in pharma-funded research for psychoactive drugs

In the final months of Rebecca Riley's life in Hull, Massachusetts, a school nurse said the little girl was so weak she was like a "floppy doll." The preschool principal had to help Rebecca off the bus because the 4-year-old was shaking so badly.

Rebecca — who had been diagnosed with attention deficit hyperactivity and bipolar disorder, or what used to be called manic depression — died Dec. 13, 2006 of an overdose of prescribed drugs. Rebecca was found dead on the floor of her parents' bedroom wearing only a pink pull-up diaper and gold-stud earrings, on top of a pile of clothes, magazines and a stuffed brown bear.

According to the medical examiner, Rebecca died of a combination of Clonidine, a blood pressure medication Rebecca had been prescribed for ADHD; Depakote, an antiseizure and mood-stabilizing drug prescribed for the little girl's bipolar disorder; a cough suppressant; and an antihistamine. The amount of Clonidine alone in Rebecca's system was enough to be fatal, the medical examiner said.

The two brand-name prescription drugs are approved by the Food and Drug Administration for use in adults only, though doctors can legally prescribe them to youngsters, and do so frequently.



Rebecca's death has inflamed a long-running debate in psychiatry. Some psychiatrists believe bipolar disorder, which was traditionally diagnosed in adolescence or early adulthood, has become a trendy diagnosis in young children.

"As a clinician, I can tell you it's just very difficult to say whether someone is just throwing tantrums or has bipolar disorder," said Dr. Oscar B. Bukstein, a child psychiatrist and associate professor at the University of Pittsburgh.

Marcia Angell's comments are particularly insightful. They'll appear in the forthcoming NY Review of Books in the issue of Jan. 15, 2009:

Some of the biggest blockbusters are psychoactive drugs. The theory that psychiatric conditions stem from a biochemical imbalance is used as a justification for their widespread use, even though the theory has yet to be proved. Children are particularly vulnerable targets. What parents dare say "No" when a physician says their difficult child is sick and recommends drug treatment? We are now in the midst of an apparent epidemic of bipolar disease in children (which seems to be replacing attention-deficit hyperactivity disorder as the most publicized condition in childhood), with a 40-fold increase in the diagnosis between 1994 and 2003.

Take the case of Dr. B., widely reported in Boston recently, about a professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at a major Harvard teaching hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age.

Legally, physicians may use drugs that have already been approved for a particular purpose for any other purpose they choose, but such use should be based on good published scientific evidence. That seems not to be the case here. The doctor's own studies of the drugs he advocates to treat childhood bipolar disorder were, as the New York Times summarized the opinions of its expert sources, "so small and loosely designed that they were largely inconclusive."

In June, Senator Grassley revealed that drug companies, including those that make drugs he advocates for childhood bipolar disorder, had paid Dr. B. $1.6 million in consulting and speaking fees between 2000 and 2007. Two of his colleagues received similar amounts. After the revelation, the president of the hospital and the chairman of its physician organization sent a letter to the hospital's physicians expressing not shock over the enormity of the conflicts of interest, but sympathy for the beneficiaries: "We know this is an incredibly painful time for these doctors and their families, and our hearts go out to them."

Rebecca's case has lots of blame to go around, and many factors were involved. At this time, we can be sure of few things. Three things seem clear:

1. The consulting and speaking fees seem like a lot of money – enough to influence the doctor's judgment.

2. In the gray zone of the proper selection and dosage of psychoactive drugs for children, where the FDA has not specifically approved their use, we need research to be as pure, as unbiased, as possible.

3. Drug companies now own the right to cherry-pick the findings and the studies they fund, and they do so.

My opinion is that we must make doctors fully free to publish the results of their studies, and let the chips fall where they may. If so, more negative results of the usefulness of psychoactive drugs will probably be published. Currently, the drug companies often suppress such findings, e.g., as was done in half of studies of anti-depressants, according to a January 2008 article in the New England Journal of Medicine. If all such studies are published, doctors will be more skeptical of the value of these drugs, and are likely to prescribe them less frequently. We have to ask ourselves whether insisting, through government regulation, that doctors have this freedom to decide what to publish, and whether requiring doctors to disclose their research funding sources and amounts, would have saved the lives of Rebecca and other children.

Advice: Try to tighten your state’s requirements for disclosure of drug research studies and free rights for doctors to publish all research they perform.

Thanks to Helen Haskell and to Marcia Angell. Thanks also to the Associated Press for their article on March 23, 2007.

If David could speak from his grave: Regulations on drug companies' gifts to doctors

David Olson's story appeared here more than a year ago.

Officials in the Massachusetts Department of Public Health are now writing regulations about the disclosure of gifts that doctors get, e.g., from drug companies, according to an article by Liz Kowalczyk in the Boston Globe of Dec. 6.

If David could speak from his grave, he might want his voice heard loud and clear on this. A drug company was paying David's psychiatrist thousands of dollars for participating in a drug study. After David's death, the state medical board criticized the doctor, concluding that he had "failed to appreciate the risks of taking Patient 46 off Clozaril, failed to respond appropriately to the patient's rapid deterioration and virtually ignored the patient's suicidality." It's hard to avoid concluding that the payment of thousands of dollars for recruiting each of a number of patients into the drug trial had affected the doctor's judgment.

Worse, this was no "bad apple." The doctor was the president of the Minnesota's psychiatric society.

Officials in Massachusetts are now considering whether doctors must disclose payments for research and research-related activities. Note that, whatever they decide, doctors will be free to receive these payments. The issue at stake is only whether patients will be able to find out about it.

Advice: Work to ensure that doctors disclose the sources of their money.

Read a story about a different conflict of interest by a doctor.

An hour after being discharged from the Emergency Room: A family physician's conflict of interest

Question for the Ethicist:
I am a family physician. A patient I'd not seen in months passed away about an hour after being discharged from an emergency room. Her mother, also my patient, asked me to review the records and autopsy to see if she should bring a malpractice suit against the E.R. physician and the hospital. I am friends with the physician and on the hospital's board. Ought I to comply with this request?
-J.R., Connecticut

Answer:
You should not. Indeed, you cannot – not properly, not without risking charges of bias. Your attachment to your friend and your position on the hospital’s board create – or may seem to create – divided loyalties. You should recuse yourself from this task, explain to the patient's mother why you are doing so and refer her to a disinterested physician with the expertise to review the records and advise her how best to proceed.

Update:
J.R. met with the family but did not offer a medical opinion, explaining that the records offered insufficient information for him to do so. He said he believed that they would not be satisfied unless the matter were investigated further and so suggested they speak to a lawyer who would have a neutral expert review the case.

Read about another ethical issue.

Thanks to Randy Cohen for the source story in the Ethicist column in the New York Times Magazine of May 25.

An hour after being discharged from the Emergency Room: Conflict of interest on a potential malpractice suit

Dr. J.R.'s question:
I am a family physician. A patient I'd not seen in months passed away about an hour after being discharged from an emergency room. Her mother, also my patient, asked me to review the records and autopsy to see if she should bring a malpractice suit against the E.R. physician and the hospital. I am friends with the physician and on the hospital's board. Ought I comply with this request?


Ethicist Randy Cohen's answer:
You should not. Indeed, you cannot – not properly, not without risking charges of bias. Your attachment to your friend and your position on the hospital's board create – or may seem to create – divided loyalties. You should recuse yourself from this task, explain to the patient's mother why you are doing so and refer her to a disinterested physician with the expertise to review the records and advise her how best to proceed.

Update: J.R. met with the family but did not offer a medical opinion, explaining that the records provided insufficient information for him to do so. He said he believed that they would not be satisfied unless the matter were investigated further and so suggested they speak to a lawyer who would have a neutral expert review the case.


Advice to family members considering a lawsuit for a medical error: Consult a doctor or nurse who was not involved.


Thanks to Randy Cohen for the source article in the Ethicist column of the New York Times Magazine of May 25.

He's suing the device maker: Prodisc artificial spinal disk lawsuits

Calvin Timberlake, a 50-year-old former forklift operator who lives in Texas, had a Prodisc implanted in his spine four months after the US Food and Drug Administration approved it. Prodisc is an artificial metal and plastic spinal disk that is meant to relieve lower back pain by replacing a damaged disk between vertebrae of the spine. Calvin's surgeon was not involved in the clinical trial, though he apparently had invested in Prodisc. The Prodisc soon came apart, requiring an emergency operation to remove it. Calvin remains in extreme pain, and has to take medication to control the pain.

Calvin is suing Synthes, the Prodisc's maker, but not his surgeon, whom he does not blame for the problems.

Many of the surgeons who co-authored articles in peer-reviewed medical journals had major investments in the Prodisc, and at least some of them did not disclose their investments to the journal editors when they submitted their manuscripts for publication. They stood to profit financially if the Prodisc succeeded in the market, according to confidential information from a patient's lawsuit that was settled last year.

Advice to people who may have surgery to implant a medical device: Ask your surgeon's office manager if the surgeon has a financial stake in the device.

Browse for related stories in the index at the very bottom of this page, or read another Texas spinal surgery lawsuit story.

Thanks to Reed Abelson for the source article in the Jan. 30 issue of the NY Times.

The team doctor cleared him to play: Laveranues Coles' concussion treatment

New York Jets football player Laveranues Coles had sustained a concussion on Oct. 28 in a loss to the Buffalo Bills. The Jets coaches held him out for one game, and he presumably passed the neuropsychological tests that the league made mandatory this year. Apparently the team doctors cleared him to play, and he returned to the football field for several games.

While discussing his reputation for playing hurt, he said, "Sometimes I may need somebody to step in there at certain times and say, 'Laveranues, I think you need to do what's best for you.' But it is what it is."

Pete Kendall, a former Jets lineman now with the Washington Redskins, said he was "concerned for Laveranues. He seemed more subdued [when playing later that season] than normal." Lethargy is a common sign of an unhealed concussion.

Pete questioned whether critical decisions should be made by team-employed doctors, saying "I see guys playing in games that I don't think a personal advocate would allow them to do. The doctor who is supposed to be looking out for you is also the same guy who may put you into a game that the team has to win. You're mixing business with medicine."

Advice to the parents of injured athletes: Get a second opinion to verify the team doctor's opinion of your athlete's readiness to play.

Browse for similar stories in our index at the very bottom of this page, or read a athlete’s story.

Thanks to Alan Schwarz for the source story in the Dec. 22 issue of the New York Times.