Tight FDA controls on isotretinoin (Accutane) prescribing have failed to reduce the number of pregnancies in women on the acne drug. Isotretinoin, a vitamin A derivative, carries a 35% risk of severe birth defects. The drug is indicated for severe cystic acne, but is commonly prescribed for mild cases.
A year ago, concerned by the high number of women becoming pregnant while taking isotretinoin, the FDA required patients, physicians and pharmacists to enrol in its iPledge program. This includes receiving and understanding detailed information about the drug and its side effects and, for premenopausal women, taking birth control and passing pregnancy tests before each refill. After a year, the number of pregnancies remained constant at about 120.
The FDA data doesn't know why the pregnancies occurred. Although all childbearing-age women were supposed to be using two forms of birth control, only 90% of the pregnant women were. Seventy-two percent say they were on the pill and using male condoms; an astonishing 18% cited "abstinence" as their birth control method. The remaining 10% aren't accounted for, although the FDA reported that two women, who were pregnant when they started on the drug, had prescribers falsify their pregnancy tests to get access to Accutane.
So are these pregnancies the result of bad luck, carelessness, stupidity or deceit? It's most likely a combination.
Another culprit is overprescibing of this strong med. Although it's only indicated for "severe recalcitrant nodular acne," which affects a tiny proportion of the population, it's commonly prescribed for normal acne. "[I]t's estimated that in the U.S., 90% of prescriptions are off label," Lynn Martinez, Utah State Health Department coordinator of the Pregnancy Riskline in Salt Lake City told WebMD.
The same article points out that isotretinoin is far worse than thalidomide, carrying a 35% chance of birth defects versus 20% with thalidomide. However, many dermatologists consider isotretinoin something of a wonder drug and oppose tighter restrictions or its removal from the market. "[iPledge] is one of the worst things that's happened to our specialty. We're taking a very good drug that is for many people the only real choice out of reasonable access," Boston dermatologist Dr Ranella Hirsch told the New York Times. In fact, an FDA advisory committee recommended on August 1 that prescribing restrictions be relaxed slightly.
In Canada, isotretinoin carries an additional warning about depression and suicidal ideation, but there is no equivalent safety program to the FDA's iPledge. Health Canada reports a total of three fetal disorders possibly caused by Accutane from January 1983 to December 2004, but the Motherisk program at Toronto's Hospital for Sick Children says they see up to 20 such cases per year.
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Tuesday, 7 August, 2007
Does Accutane prove vanity trumps good sense?
US docs should strike... for universal care?
Doctors should go on strike to demand a universal, single-payer healthcare system, urges prominent American psychiatrist and author Stephen J Bergman (right) in a Boston Globe op/ed:
Soon after HMO/managed care came to Massachusetts in the late '80s, I got a call from a patient I had admitted to the 28-day alcohol unit at the hospital. He said that he was being discharged after three days because that was all that the HMO would now pay for alcoholism. He said the HMO representative told him to go out and get drunk again and they would readmit him. [...]
Change will not originate from the top. In any hierarchical system, the only threat to the dominant group is the quality of connection among the subordinate group. This is true of race, gender, class, ethnicity, and sexual preference. In three great movements of my lifetime -- women's rights, civil rights, and the ending of the Vietnam War -- change came from my generation seeing an injustice and believing that by organizing together at the grass-roots level we could right an obvious wrong. And now?
I propose a doctors strike.
It seems strange that as Canadian physicians edge towards increased privatization, many American doctors are headed in the opposite direction. (I brought this up in our recent roundtable discussion about Michael Moore's SiCKO.)
(Thanks to Josh Umbehr, writing at KevinMD.)
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Monday, 6 August, 2007
"The doctor will triage you now"
An Edmonton hospital's new "triage liaison physician," or TLP, cut wait times by 36 minutes, says a new study published in Academic Emergency Medicine. Lead author Dr Brian Holroyd, speaking to the Edmonton Journal, called the TLP idea the "most effective" change that the University Hospital ED has made to reduce wait times. The Journal explains how the TLP works:
Unfortunately, the hospital's innovative wait-time reduction strategy is being undermined by an overall physician shortage, the Journal reports.The new doctor, who works 11 a.m. to 8 p.m. each day, takes all phone calls from ambulances and rural centres so other treating doctors aren't interrupted at patients' bedsides. The doctor also helps the triage nurses by visiting patients in the waiting room and on ambulance gurneys, and ordering early blood work and lab tests so that there is no delay when the patient gets a bed.
That extra physician hand decreased the total amount of time spent in emergency to four hours and 21 minutes from four hours and 57 minutes. The time is measured from when a patient walks in the doors until he or she is completely treated or else admitted.
Photo: Dr Holroyd talks to Capital Health dignitaries (www.capitalhealth.ca)
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Hospital laptops stolen, health authority keeps mum
Last week Edmonton's Capital Health Region admitted that four hospital laptops containing medical records of 20,000 patients' records were stolen. In May. 'There's no particular urgency to this, no one's health is going to be compromised,' he said.
That's right, the laptops were stolen in May.
So why is this just coming to light now, not only for the media but for the patients whose information was stolen? The CBC reports:[Capital Health Region] spokesman Steve Buick said the reason they took so long to inform the public is because they wanted to consult with the Privacy Commissioner.
What leads them to believe that?
The laptops had cable lock devices to secure them to staff desks in a secure building, but the thieves managed to steal them in the evening, said the health authority. Only one of the four computers had patient information on it, information that is only available by getting past two passwords.
Was three months a reasonable amount of time for the Capital Health Region to delay notification?
Last Wednesday, the Privacy Commissioner of Canada, Jennifer Stoddart, released new privacy breach guidelines (PDF). A sentence in Step 3: Notification reads, "Notification of individuals affected by the breach should occur as soon as reasonably possible following assessment and evaluation of the breach."
The CBC article provides some context for a reasonable notification time: Last December, just a quick drive south on provincial highway 2, Calgary Health Region lost a laptop to theft, compromising over 1,000 patients' information -- all of them children in a mental health program. The Calgary administration notified families immediately.
The result? The health region got a slap on the wrist from the provincial privacy commissioner for failing to follow several security policies, but got away largely unscathed. An investigator even lauded their efforts: "For the most part, the Calgary Health Region does a good job protecting information, and has been taking steps to improve security."
In January, a doctor's laptop containing health info on nearly 3,000 Toronto Sick Kids' patients was stolen. The hospital in that case waited two months before telling the public, leading to a change in Ontario's privacy rules. In June, Lonny Rosen, NRM's Health Lawyer columnist, offered advice to docs on how to keep patient information safe on a laptop:
I'm afraid this decision sends a clear message that sensitive patient information should never be stored on a laptop (or even sent by email) unless it's de-identified or encrypted.
Wednesday, 1 August, 2007
Canadian docs stage private care putsch
The Canadian Medical Association's new "Medicare Plus" vision, announced by outgoing president Dr Colin McMillan (right) in a Charlottetown speech July 30, has stirred up the debate about the role of privately funded healthcare in Canada.
In the new CMA policy document (PDF), released the day of Dr McMillan's speech, the group asks governments and the public to:
- Allow doctors to practise in the private and public systems at the same time;
- Expand wait-time benchmarks to more areas of medical care;
- Guarantee treatment within those benchmarks and, if they cannot be met, subcontract the private sector -- as has already been mandated to a limited degree in Quebec with Bill 33, following the Supreme Court's Chaoulli decision;
- Create a national strategy to increase the number of healthcare workers;
- Expand public insurance to cover individuals' "catastrophic" drug expenses and long-term care costs.
"Any collection of doctors are entitled to their opinion and there are many things we agree with them on, but on the issue of physicians having a dual practice or two-tier system, we're not going down that road." - "Two-Tier" Tony Clement, federal Minister of Health
"[While] many doctors disagree strongly with proposals that would undermine public health care, the CMA leadership has chosen self-interest over public interest." - Dr Gordon Guyatt, Canadian Health Coalition
"Is the CMA SiCKO?" - Canadian Health Coalition
"Politicians should not look at this option for very long... It is hard to avoid the conclusion that the prime beneficiaries of the CMA's policy would be the CMA members." - The Globe and Mail editorial
"Rather that [sic] dismantling our public health-care system piece by piece, the CMA would do better to concentrate on solving challenges in Canadian health care within medicare..." - Danielle Martin, Canadian Doctors for Medicare
Not everyone's opposed to the CMA policy, however:
"Now that’s a refreshing look at health-care reality. Plus, it’s high time the official voice of 60,000 Canadian doctors entered the fray and realized Canada’s health-care system is about to kick the bucket unless it receives a massive injection of policy-change truth serum." - Bruce Strachan, former BC MLA, writing in the Prince George Citizen
“If there are ways to combine public money and private business practices in ways that make the health system more efficient, we should use them, and we certainly can't be afraid to discuss the options openly.” - Ottawa Citizen editorial
"In fact, the CMA's consideration of more private care is both cautious and modest... The doctors aren't exactly throwing open the doors to unregulated, jungle medicine. What they are doing is insisting that a level-headed discussion ensue, for the sake of patients, not profits. There's nothing radical about that." - Kingston Whig-Standard editorial
For their part, the CMA claim 62% of 1,802 Canadians surveyed support the plan (PowerPoint file).
What's next in the debate? Well, mark your calendars for August 19, when the CMA Annual Meeting kicks off and Brian "Dr Profit" Day takes the reins of the group. Unlike Dr McMillan, he's unlikely to wait a full year to let his opinions be known. (Read NRM's Q&A with Dr Day from last fall, after he was elected CMA president.)
Update, August 8, 2007: CMA Public-Private Interface Committee co-chairs Dr. Robert Hollinshead and Dr. Suzanne Strasberg defend the Medicare Plus plan in an op/ed to The Globe and Mail: "The physicians of Canada make no apologies for raising these issues on behalf of their patients. In fact, we think it is our responsibility."
Photo: CMA
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Better treatment and monitoring needed for pedophiles: Whitmore lawyer
The kidnap and rape of two Prairie boys by convicted pedophile Peter Whitmore (right) may have been prevented by better treatment and monitoring of sex offenders, writes Mr Whitmore's lawyer Daniel Brodsky in an open letter to Prime Minister Stephen Harper. Mr Brodsky is urging the PM to call an inquiry into the case; he says the government is not doing enough to prevent pedophiles from re-offending.
Mr Whitmore agreed to a plea bargain with the Crown last week. In exchange for a guilty plea, the Crown would not seek dangerous offender status. He has been sentenced to life in prison.
I spoke to Mr Brodsky last September, just after Mr Whitmore was arrested following the abduction of the two boys. He told me Mr Whitmore is a sick man who has absolutely no insight into his behaviour. The lawyer, who has represented the repeat offender several times, was disdainful about the way mentally ill criminals are handled by Correctional services: "Seventy percent of inmates have a mental illness," he said. "Almost none of them are getting treatment."
He adds that the convicts themselves - including Peter Whitmore - generally don't want to go to hospital:"In the penitentiary, you're allowed to work, have recreation, conjugal visits - and not required to have any treatment. If he doesn't cause a problem, he'll be moved to lower security. In the penitentiary, he'll have rights. In a hospital, he'll have privileges."
He has reportedly requested 'chemical castration.' This usually involves administration of the birth control drug Depo-Provera to inhibit the testicles from producing testosterone. The treatment has not been proved to prevent sexual offender recidivism.
Photo: RCMP
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