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Thursday, February 28, 2008

She can't help but wonder: Adverse effects of Procrit and Aranesp

Belinda G.'s mother was a chemotherapy patient who was also given anemia drugs. Although Belinda acknowledges that her mother was dying of small cell cancer, Belinda can't help but wonder if the use of anemia drugs resulted in her mother passing away sooner than she would have otherwise.

My mom had been sick since 2000 with lung cancer and it was small cell carcinoma at that time. She beat it and went into remission in 2001. She had never had Procrit or Epogen prior to her remission. Her cancer came back and the cancer spread to her adrenal glands and her organs. They did radiation every day for 10 days and chemo at the same time. The Procrit was given to her in injections that started around February or March 2002.

She was a fighter—at the beginning she even continued working and running apartments. Once she started getting shots more frequently, her cancer got progressively worse. She died rather suddenly on January 15, 2003. She was on the shots until she passed away.

They [medical staff] were telling her that she needed to have the shot because her cell count was low. One time, she asked for it as though she believed it was something she needed to help the situation. I asked why she was taking it, when she did better without it. Back then, there was not a lot known about that.

Every time my mom had chemotherapy, they gave her the anemia shots. She had been doing well until they started the shots. Did they accelerate the process? I don't know. Small cell is inoperable and there was nothing we can do about it. But I think the anemia drugs might have progressed the situation.

Belinda is not the only one left wondering if anemia drugs either caused a loved one's death or accelerated the rate at which a loved one has died. In November, the FDA strengthened the safety warning on Aranesp, Epogen and Procrit to alert patients to the risk of death, heart attack and the progression of certain cancers. Additionally, a new study has been released linking anemia drugs to an increased risk of leukemia in patients with myelofibrosis.

Doctors have also been warned to use the lowest possible doses of the anemia drugs required to avoid a blood transfusion. Patients who receive higher doses of Aranesp, Epogen or Procrit are at an increased risk of accelerated tumor development.

Today Andrew Pollack of the NY Times described a meta-analysis (carefully pooling the results of multiple studies) in the Journal of the American Medical Association (JAMA). Dr. Charles Bennett and the other authors of the study found that widely used anemia drugs raise the risk of death among cancer patients by 10%.

The U.S. Food and Drug Administration (FDA) will convene a meeting on March 13 to discuss restrictions on the use of the drugs.

Advice to cancer patients taking Aranesp or Procrit: Alert your doctor to the study in this highly esteemed medical journal, and ask your doctor whether and how it should affect your treatment.

Browse for similar stories in our index at the very bottom of this page, or read an FDA drug review story.

Thanks to Heidi Turner for the source story in the Jan. 1 issue of LawyersandSettlements.com.

Monday, February 25, 2008

He retired at 34: Concussions in football receiver Wayne Chrebet

At age 34, Wayne Chrebet retired from his football career with the New York Jets because of post-concussion syndrome, after suffering at least six concussions. He sometimes had returned to games in which he had been knocked unconscious. He was the third star pass receiver on the New York Jets to retire because of post-concussion syndrome, along with Laveranues Coles and Al Toon.

Wayne has recently acknowledged he has bouts of depression and memory problems so severe that he cannot make the routine drive from his home in New Jersey to his restaurant in Long Island without a global positioning system.

The Jets' team physician has drawn criticism because he is both the leader of the National Football League’s commission on concussions and because under his care, three of his team's star receivers have had multiple concussions that ended their careers and left them with permanent disabilities. The team physician's desire to both help his team win and care for the players' health poses an innate conflict of interest.

Advice to parents of football players: Make sure you get your son's family physician to independently verify the team physician's clearance for him to resume play.

Browse for related stories in the index at the very bottom of this page, or read another football story.

Thanks to Alan Schwarz for the source story in the NY Times of Dec. 22.

Sunday, February 24, 2008

It's hard to be my doctor: Surgeon DeBakey as patient

The pioneering heart surgeon's story:
The doctor who operated on me only a few years ago was one I trained. I was lucky to have somebody like that.

[Dr. DeBakey, now 99, pioneered numerous cardiac procedures, including the cardiac bypass and the artificial heart transplant. In 1954, he devised a technique to repair arteries using a Dacron tube he made on his wife's sewing machine. In 2006, he became the oldest survivor of the procedure he invented.]

Never had a symptom. The pain came like a bullet out of the blue. I was alone when it started. My wife and my daughter had gone out. The pain is often described as the worst pain you can have. The pain was so severe that I would have welcomed anything to relieve it – including death. I wasn't going to fight it I look upon death as a part of living, just as some trees lose all their leaves in the winter and have them replaced in the spring. But at the same time, part of me was thinking, What caused this pain? Part of me was doing a diagnosis on myself – which, as it turned out, was correct. Aortic dissection. I'd written more articles about the condition than anybody in the world, and I resigned myself to having a heart stoppage. The pain didn't teach me anything about the heart. It simply emphasized what I had already learned.

I was a little surprised to find myself recovering after the surgery. Then gratified to have been given a second life.

During my recovery, I played possum. I pretended to be sleeping and listened to what the doctors standing over my bed were saying about my condition. Then I'd argue with them about the therapy. I'd make them prove I needed it.

I guess it's hard to be my doctor.

Advice: Be a polite and vigorous advocate for your care in the hospital, or get a patient advocate.

Browse for related stories in the index at the very bottom of this page, or read another story about Dr. DeBakey.

Thanks to Cal Fussman for the source interview of Dr. DeBakey in the March 2008 issue of Esquire magazine.

Saturday, February 23, 2008

The insurer pulled the rug out from under her: Lawsuit on insurer’s refusal to pay for breast cancer treatment

A Southern California woman who had her medical coverage canceled as she was undergoing treatment for breast cancer was awarded more than $9 million Friday in a case against one of California's largest health insurers.

Patsy Bates, a 52-year-old mother of two, had previously been insured with another company but was persuaded to switch to a Health Net policy after an agent suggested she could save money.

She said she had undergone surgery to remove a tumor and had received her first two chemotherapy treatments when doctors stopped treating her because her bills were going unpaid.

Patsy, a hairdresser from Lakewood (Los Angeles County), had been left with more than $129,000 in unpaid medical bills when Health Net Inc. canceled her policy in 2004. The insurer contended that she had failed to disclose a heart condition and lied about her weight when she applied for the policy in July 2003.

But arbitration judge Sam Cianchetti ordered Health Net to pay her medical bills, plus $8.4 million in punitive damages and $750,000 for emotional distress.

"It's hard to imagine a situation more trying than the one Bates has had to endure," the judge wrote in his findings. "The rug was pulled out from underneath, and that occurred at a time when she is diagnosed with breast cancer, one of the leading causes of death for women."

Health insurers have come under fire from state regulators, attorneys and advocates for using mistakes or omissions in a member's application to justify canceling coverage after a policyholder becomes ill.

Friday's award marked the first punitive damages ordered by a judge in a case against an insurer for rescinding policies. Hundreds of cases in California have been settled quietly in confidential agreements.

"This punitive award will do more than anything to stop the shameful practice of post-claiming underwriting," said Bates' attorney, William Shernoff. "Other health insurers will obviously have to hear the message that the practice of canceling people's health insurance after they become sick will not be tolerated by the public."

Health Net officials released a statement Friday saying the insurer will rescind no policies in the future without a binding, third-party review process.

Health Net also said it would conduct a review of its practices and the way its brokers and agents are trained. The company said it is working with state regulators and will make additional announcements in the coming weeks.

Friday's award capped a difficult week for the insurer, which included being sued by the Los Angeles city attorney on claims of unlawful and deceptive business practices in connection with its rescission practices. City Attorney Rocky Delgadillo also said the company illegally ran an incentive program in which it paid bonuses to an administrator for meeting policy-cancellation targets.

"I don't have anger toward the company," said Patsy, whose cancer is in remission but who has some health problems. "I hope what they're saying is true, and that they're going to change their policies and take care of the people they insure."

Advice: Avoid insurers whom consumers frequently identify as refusing to pay for care when their beneficiaries get sick. Call your local Better Business Bureau and state Attorney General's office to find out their track record.

Browse for similar stories in our index at the very bottom of this page, or read a an Insurance Warrior story.

Thanks to the San Francisco Chronicle staff for today's source story.

Friday, February 22, 2008

Susan Sontag's choice for aggressive care

David Rieff's story on his mother, Susan Sontag
What my mother wanted – which was to undergo any treatment, no matter how terrible, that promised a cure for her disease – would probably have been viewed skeptically by a physician schooled in what Dr. Jerome Groopman calls the "bean counting" of evidence-based medicine. But doctors like Nimer and Groopman hold that their mission is to try to treat their patients as their patients want to be treated until doing so can be called with assurance (rather than in terms of probability alone) medically futile.

Obviously, there is a cost to this. In opting for treatment – in her case, a bone-marrow transplant – my mother suffered far more physically than she would have had she opted for palliative care alone. But in honoring her wishes, without for a moment understating the risks, her doctors opted for treating her in the full, human sense of the word.

Advice: Find a doctor who takes to heart your preferences about risks and benefits, and the degree of aggressiveness you want in your care.

Browse for related stories in the index at the very bottom of this page, or read another story from David’s book.

Thanks to David Rieff for the source story in Sunday's New York Times Magazine, drawn from his book, Swimming in a Sea of Death: A Son's Memoir.

Thursday, February 21, 2008

This nonsensical situation: Prohibition on personal injury lawsuits about medical devices

In 1994, the U.S. Food and Drug Administration issued its pre-market approval for the use of a balloon catheter made by Medtronic for widening coronary arteries. Two years later, Charles Riegel underwent angioplasty – a form of heart surgery that uses a special balloon device to mash plaque against the walls of the artery to allow blood to flow more freely. The balloon catheter burst while being inserted, injuring him. He filed a lawsuit against Medtronic, the device maker, but the case was dismissed. He died after the lawsuit was filed, and his widow, Donna, carried on the case, appealing the dismissal of the case to the U.S. Supreme Court.

The Supreme Court decided on Wednesday that makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the FDA approved the device before it was marketed and the device meets the FDA's specifications.
The case turned on what Congress had meant by a clause in the 1976 Medical Device Amendments statute that bars states from imposing different requirements from federal requirements. The justices apparently decided on the Congress' intent without asking either of two current congressmen who had key roles in moving the bill forward back in 1976. Both the Senate’s sole sponsor of that legislation – Sen. Teddy Kennedy – and Rep. Henry Waxman, a member of the House panel that approved the bill, were sharply critical of the decision.

Sen. Kennedy commented, "In enacting legislation on medical devices, Congress never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices." Rep. Waxman said, "The Supreme Court's decision strips consumers of the rights they've had for decades. This isn't what Congress intended, and we'll fix this nonsensical situation."

Advice to people who may need surgery to implant a medical device: Do your homework carefully to understand the safety of various devices.

Browse for related stories in the index at the very bottom of this page, or read a medical device malfunction story.

Thanks to Linda Greenhouse for the source article in today's NY Times.

Wednesday, February 20, 2008

This sounds insane, and it is: Refusing payment for hospital drug errors

On Feb. 14, the Boston Globe described a study by my esteemed colleague Dr. David Bates that revealed that one in ten patients had serious preventable drug errors during their treatment at six selected community hospitals in Massachusetts.

Today the Globe published my letter in response, under the heading "Put hospitals on path to improvement:"

To the Editor:
The article is shocking. Adding insult to all these injuries is the fact that patients pay for these errors. Health insurers pay the hospitals as billed, and insurers build in all the costs when they set our insurance premiums.

The most powerful thing we can do as patients is to urge our insurers not to pay for hospital errors that we suffer. Insurers could withhold payment to the hospital, which would send the hospital the right message. Otherwise, given the reimbursement system, hospitals could benefit financially for additional days of hospital care that were incurred because of an error. (This sounds insane, and it is, as I know all too well from my work in patient safety.)

Consumers must demand safer hospital care. Strangely, this could be the best way to get it.

Browse for similar stories in our index at the very bottom of this page, or read a story on pending legislation to report and reduce hospital errors.

Sunday, February 17, 2008

She wanted the science as well as the magic: Susan Sontag's patient-doctor relationship

David Rieff's story:
When my mother [Susan Sontag] found out she had myelodysplastic syndrome, the terrible blood cancer that eventually took her life, she oscillated between numb despair and acute panic. When she was panicked, nothing those who loved her did or said could calm her down, let alone console her. And yet we soon learned that if we could reach Stephen Nimer, her principal physician at the Memorial Sloan-Kettering Cancer Center, by telephone, or if, better still, Dr. Nimer could make the time to see my mother, however briefly, her awful distress would abate – at least for a while.

Observing my mother's exchanges with Dr. Nimer, I could not help wondering why what he said consoled her. For he never played down the lethality of the disease, nor did he hold out false hope. Doubtless, Dr. Nimer's long experience with gravely ill people, the hard-won human skills he acquired over decades of practice, played a central role. The comfort my mother derived from speaking with him was also due to her own very traditional conception of their relationship. She had no time for alternative medicine, nor did she believe that her will would somehow be strong enough to counter the scientific realities.

But my mother's relationship with her principal doctors was only fully effective because in some ways it was shamanistic. Of course, she wanted the science as well as the magic….

Advice: Find a doctor who knows both medical science and the magic of consolation.

Browse for related stories in the index at the very bottom of this page, or read a compassionate care story.

Thanks to David Rieff for the source article in today's NY Times Magazine, drawn from his book, "Swimming in a Sea of Death: A Son's Memoir."

Saturday, February 16, 2008

The scar adds to my collection: medical malpractice in heart surgery

Blogger Espe’s story:

Dec. 7, 2007:
so, my heart surgery is just around the corner...damn...i've been waiting since june for my heart problem to have some closure and that day is almost here. i thought i'd be shitting it by now, but i'm not. i'm looking forward to the morphine and other prescription pain killers...and the scar....well, it adds to the collection. hopefully, i'll be out of the hospital before christmas. it would really suck having to spend the holiday in the hospital. i don't want to put my family through that again.

Feb. 16:
since today it has been two months since i've been in the hospital. i came in for a heart surgery that was supposed to last four hours, but i've been stuck here for a medical malpractice that occurred during the surgery. i basically ended up with my right leg cut on both sides by a vascular doctor by emergency during the surgery because my leg was swollen. the team who did my heart surgery did not notice my leg until the surgery was over. i've been through near amputations, various procedures including three leg debridements, and i've had to learn how to walk two times already using a walker (actually it's hopping on my left leg because i still can't use my right leg), but hopefully i will be having my skin grafts next week and if it all goes well i may be home two weeks from now.
there's a bunch of other stuff i want to get into about my stay here, but i'm way tired and it's hard to type. my ring and pinky finger have been numb since after my first surgery. i don’t know how long they will stay that way, but they make it a mission to type on the laptop.
i miss so many things, but i will hopefully get to do them all after i get out. i won't be the one driving, though, for God knows how long.

Advice: Have a patient advocate with you in the hospital.

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

Thanks to espe for the source blog post.

Friday, February 15, 2008

Life rolls on: Living after a spinal injury

At 17, Jesse Billauer aspired to be a professional surfer. Then one day in 1996, while surfing off a Southern Californian beach, a wave knocked him into a sandbar and broke his neck, leaving him quadriplegic. Friends and neighbors raised money for Jesse's medical expenses. After a few years, when his medical bills were paid, he and his brother Josh decided to use the money to start an organization that would raise awareness about spinal cord injury as well as money for research.

"After my injury everyone kept saying, 'Well, life goes on,' and I thought, No, life rolls on," Jesse says.

So far, Life Rolls On has raised more than $1 million, says Josh, who serves as chairman of the board.

"When you've put all the effort in and see the smiling faces of people surfing who never thought they could even get into the ocean, you tend not to dwell on how much time and energy went into everything," Josh says.

Advice to people who have suffered great misfortune: Look for some way you can get your life to roll on through doing something you love.

Browse for similar stories in our index at the very bottom of this page, or read another story on a gritty athlete who became a fund-raiser.

Thanks to Stephanie Cajigal for the source story in the January/February issue of Neurology Now.

Thursday, February 14, 2008

The same genetic lightning bolt: Rare DNA defects among some autistic and developmentally delayed children

The girls had never met, but they looked like sisters. There was no missing the similarities: the flat bridge of their noses, the thin lips, the fold near the corner of their eyes. And to the families of 14-year-old Samantha Napier and 4-year-old Taygen Lane, there was something else, too. In the likeness was lurking an explanation for the learning difficulties, the digestion problems, the head-banging that had troubled each of them for so long.

Several of the adults wiped tears from their eyes. "It's like meeting family," said Samantha's older sister, who accompanied her and their mother to a Kentucky amusement park last July to meet Taygen.

But the two families are not related, and would never have met except for their unusual bond: a few months earlier, a newly available DNA test revealed that Samantha and Taygen share an identical nick in the short arm of their 16th chromosomes.

Doctors are now learning that the symptoms of many children who are diagnosed as "autistic”"or "developmentally delayed" can be traced to the deletion or duplication of particular parts of the children's DNA. Some mutations are so rare that they are known only by their chromosomal address. For example, Samantha and Taygen are two of only six children in the world who are known to have defects in the 16p11.2 section of their DNA. (The most common mutation, on the other hand, is Down syndrome, which occurs in people with an extra 21st chromosome in addition to the usual pair.)

The affected children are typically the only ones in their families to have the disorder. So, many parents are searching out strangers who've been struck by the same genetic lightning bolt. They want solace, advice and answers to what the future might bring. From other families of children with the same chromosomal anomaly, they are seeking insight into their own. Sometimes what they find is unsettling; more often, in the emerging communities of the genetically rare, what they find is sustaining.

The genetic counselor at the University of Louisville Hospital put the girls' mothers in touch. The first time the mothers spoke, they talked on the phone for hours. When they met face to face, the questions continued.

Was Samantha sensitive to small noises? Even a cough or a sneeze can make Taygen shudder.

Samantha makes her mother unplug the clock every night because she can't stand its ticking.

Taygen is often sweet and then nasty in bewildering succession.

Samantha slaps you and then hugs you. You never know what is coming next.

It got easier, Samantha's mother told Taygen's mother. She has fewer tantrums now, and has learned her letters.

Advice to parents of autistic and developmentally delayed children: Consider getting help from an organization in Britain called Unique. They seek to link families with rare chromosomal disorders.

Browse for related stories in the index at the very bottom of this page, or read another story on the misdiagnosis of a rare genetic condition.

Thanks to Amy Harmon for the source story in the December 28 issue of the NY Times.

Wednesday, February 13, 2008

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.

Monday, February 11, 2008

The hospital's lab had mixed up her test: An unnecessary mastectomy and death

Last spring, doctors at a Long Island hospital gave a patient the news she had feared: cancer had been detected in her left breast.

She was only in her 30s, but she decided to act swiftly because breast cancer ran in her family. On May 25, she had a double mastectomy. The next day, she died from complications in the surgery.

As it turned out, she did not have cancer. According to the state Department of Health, the pathology report from the woman's surgery had found no tumors in her breasts. The hospital's lab had mixed up her test with another woman's.

Since that time, the hospital has taken corrective action, which has been deemed proper by the Department of Health.

Advice to surgery patients: Read the test results yourself and ensure the test results show your name and date of birth.

Browse for similar stories in our index at the very bottom of this page, or read another cancer misdiagnosis story.

Thanks to Cara Buckley for the source story in today's New York Times.

Saturday, February 9, 2008

I'm being Medevac'ed out a second time: US Army's medical care

I am a regular army captain - a social worker - currently stationed in Baghdad, Iraq. I have been here almost 13 months and getting ready to go to Landstuhl for possible surgery - I'm writing this from the CSH in Baghdad Internet Cafe.

Well, the horror story was when I first signed up for the Army as a private in 1983 I went to basic training at Fort McClellan, Alabama. Around the 4th week we went on bivouac and I developed a fever and heavy bleeding. They sent me to sick call (even though we were told NOT to unless we were on our death beds) and they took some tests. The fever wouldn't go down so they admitted me. Well, I was watching CNN from my hospital bed and apparently the hospital I was in had an incident... someone switched Argon Gas tanks with Oxygen Tanks and killed people in the operating room. Well, the hospital completely shut down and they stated (in the records I still own) that they felt I needed more tests to determine the cause of these problems but due to circumstances beyond their control, they were discharging me to the Troop Outpatient Clinic. Then I went back out to the Field, and things got even worse, more bleeding and continued high fever. Under the fear of saying anything I just continued my training.

When we were returning, that night in the shower, I fell down delirious, and the ambulance was called. They did a camera probe of my cervix area and found infection that had burst. They then wheeled a telephone over to me and told me to make my final phone call as it was not expected for me to live through this surgery. I called my mother. Next thing I remember was waking up and them telling me I had a total and complete hysterectomy, to include my ovaries.

I then recuperated and went through basic training a full second time and have not left the service completely for 25 years. That was March 1983 and it's almost March 2008 now. So I was unable to have children at age 19 and have been on HRT for 25 years. I have a 20-year Reserve retirement since I spent all that time in the Reserves and National Guard but have a total of 10 years active duty service. I became a social worker, direct appointment into the medical service corps 04/06 and have three more years to go.

Well, 16 years ago my ex-husband and I decided I should get implants. I loved them and they have been great all these years. Well, last July a series of rockets came into our FOB Falcon and I ran with a large box in my arms to the bunker, but, tripped and fell... causing the box to smash my left breast. They sent me to Landstuhl to have an MRI and the physician/radiologist stated that it was ruptured. Then a few hours later another doctor said that it was not ruptured. They differed in opinion and I was sent back to FOB Falcon where I didn't notice anything but the usual stinging pain in my left breast they told me was just "nerve damage" from falling on it.

Then a few days ago I noticed actual jell like blob underneath my bra strap heading south to my stomach area. They sent me here to the CSH and the doctor blatantly stated, "Since these are such a problem for us we are going to recommend they be removed." She made it sound like I was causing problems with the army medical system so they will simply remove these things. What she didn't realize was that the Army misdiagnosed the rupture 6 months ago...and it was not my fault but theirs that I'm being Medevac'ed out a second time. It was like she was disgusted that I was causing such a "non-military, non-weapon caused injury" to take up her resources.

So... now I'm waiting to fly to Landstuhl today or tomorrow to have them crassly remove my implants and NOT replace them with new saline implants. What a nightmare. I am a social worker and I don't even know how to negotiate the Army medical system to advocate for my own medical care. It's like this giant, huge blob of permanently compartmentalized disinterested individuals... much worse than a HMO like Kaiser Permanente. I feel like a number and not a human being where my thoughts on my breasts make a difference.

I have had the breast implants for 16 years and they were fine until the friggin' rocket made me fall on them... Are they going to make a law about women having breast implants in the army? I don't think so...

Anyway, thanks for letting me vent about this... The other thing was they gave me a copy of this medical record from the ultrasound I had here at the CSH and there is incorrect information all the way through the record...dates, time frames, etc. Nothing I said was placed into the medical record. It makes me frustrated and scared to face what is next for me at Landstuhl. I feel they already once removed all my female parts and now they will take these breast implants...

-Diana M. Colon LCSW, PIP
Licensed Clinical Social Worker
FOB Falcon, Iraq

Browse for related stories in the index at the very bottom of this page, or read another Iraq veteran's story.

Friday, February 8, 2008

Not until 2006: Lawsuit on interpretation of Paxil's suicide risk in drug trials

An inappropriate analysis of clinical trial data by researchers at GlaxoSmithKline obscured suicide risks associated with paroxetine, a profitable antidepressant, for 15 years, according to court documents released last month. Not until 2006 did GSK alert people to raised suicide risks associated with the drug, marketed as Paxil and Seroxat.

An analysis of internal GSK memos and reports, which were released to US lawyers seeking damages, suggests that the company had trial data demonstrating an eight-fold increase in suicide risk as early as 1989. Harvard University psychiatrist Joseph Glenmullen, who studied the papers for the lawyers, says it's "virtually impossible" that GSK simply misunderstood the data - a claim the company describes as "absolutely false."

Glenmullen's report rests on documents obtained by lawyers in Los Angeles, who are bringing around 30 cases against GSK linking suicides and suicide attempts to the use of Paxil. The report was under seal at a district court in Sacramento, California, until 18 January, when the judge agreed to make parts of it public.

The analysis focuses on the "washout" phase preceding a trial, when subjects stop taking most or all medications to avoid confusion with results from the trial itself. Because the washout occurs before patients randomly receive either the drug or the placebo control, adverse events during this time can't be attributable to the trial and so are seldom if ever included in final results.

However, GSK researchers submitting data on Paxil to the US Food and Drug Administration in the late 1980s and early 1990s included suicides and suicide attempts from the washout period in the results for the placebo arms of trials, but not from the Paxil arms. Glenmullen alleges that these extra "placebo" suicides negated suicides attributed to Paxil in the trials, making the drug appear safer than it really was. He says that if the washout results had been excluded, the data would have showed that Paxil increased eight-fold the risk of suicidal behaviour in adults.

GSK spokeswoman Mary Anne Rhyne says inclusion of the washout data "was intended to present the full picture of events that occurred in all phases of the clinical trials - starting from the time patients were enrolled, before they were randomised." She says that even without the washout data, Paxil still came out as safe as the placebo in this trial. She accused Glenmullen of incorrectly analysing the data to reach the opposite conclusion, but didn't respond to a request for numerical proof that Glenmullen's verdict was wrong.

Glenmullen suggests that the FDA would have acted differently had the use of the washout data been made more explicit. Rhyne says that material still under seal shows the FDA to be fully aware of how the washout data was being used. But Glenmullen quotes Martin Brecher, the FDA official who reviewed Paxil's safety, as agreeing during a pre-trial hearing that the use of the washout data was "scientifically illegitimate."

Independent researchers say it was wrong to use washout data as GSK did. "I can't imagine circumstances in which it would be appropriate," says Bruce Psaty of the University of Washington in Seattle.

Advice: Weigh the tradeoffs carefully in deciding whether to take antidepressants.

Browse for similar stories in our index at the very bottom of this page, or read an antidepressant adverse drug reaction story.

Thanks to Helen Haskell for sharing Jim Giles' source story in the Feb. 6 issue of the New Scientist.

Thursday, February 7, 2008

Even at low dosage: Fatal overdose of prescription drugs for Heath Ledger

The actor Heath Ledger died accidentally from "the abuse of prescription medications" – six kinds of painkillers, sleeping pills and anti-anxiety drugs – according to the New York City’s Medical Examiner's office. Heath, a star of "Brokeback Mountain," had been found dead in his SoHo apartment on Jan. 22.

The narcotics oxycodone (the main ingredient in OxyContin) and hydrocodone (the main ingredient in Vicodin), and the drugs diazepam (Valium), alprazolam (Xanax), temazepam (Restoril), and doxylamine (in certain sleeping pills and cold medicines) were found in his system.

"It's the combination of the drugs that caused the problem, not necessarily too much of any particular drug," said a spokeswoman for the Medical Examiner’s office.

Heath's father, Kim Ledger, said "we learned today the combination of doctor-prescribed drugs proved lethal for our boy. Heath's accidental death serves as a caution to the hidden dangers of combining prescription medication, even at low dosage."

Dr. Vatsal Thakkar, a psychiatrist at New York University Medical Center voiced a concern that some of the drugs Heath had taken could have built up in his body.

Advice to those taking several prescription drugs: Check here (for free) to ensure they do not have dangerous drug-drug interactions.

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

Thanks to James Barron for the source story in today's NY Times.

Wednesday, February 6, 2008

An armed guard told him his kidney had been removed: Theft ring for kidney transplants

As the anesthetic wore off, 25-year-old Naseem Mohammed said, he felt an acute pain in the lower left side of his abdomen. Fighting drowsiness, Naseem, a day laborer, fumbled beneath the unfamiliar green medical gown and traced his fingers over a bandage attached with surgical tape. An armed guard by the door told him that his kidney had been removed.

He was the last of about 500 Indians whose kidneys were removed by a team of doctors running an illegal transplant operation, supplying kidneys to rich Indians and foreigners, police officials said. A few hours after his operation last Thursday, the police raided the clinic and moved him to a government hospital. He has been recuperating in a Gurgaon hospital.

He had had no idea that it was possible to sell a kidney. He had been picking up odd jobs in Delhi for the past two years and had been sending money to his family in Gujarat.

Two weeks ago, he was approached by a bearded man as he waited at the early-morning labor market by the train station. The man offered him a generous deal: six weeks of painting work, with free food and lodging. He was driven four or five hours, to a remote bungalow, where he was placed in a room with four other young men, under the watch of two armed guards.

"When I asked why I had been locked inside, the guards slapped me and said they would shot me if I asked any more questions," he said. The men were given food to cook and periodically nurses would take blood samples. One by one, they were taken away for operations.

"They told us not to speak to each other or we would pay with our lives," he said. "I was the last one to be taken."

Advice to people needing a kidney:
Explore kidney sharing, as described here recently.

Browse for related stories in the index at the very bottom of this page, or read a kidney swap story.

Thanks to Amelia Gentleman for the source article in the Jan. 30 issue of the New York Times.

Monday, February 4, 2008

Pimp C's death from an overdose of cough syrup

Influential Southern rapper Pimp C died of an accidental overdose of a combination of drugs he had named in his lyrics - codeine and promethazine, the county coroner's office ruled Monday.

The drugs are key ingredients in "syrup," a narcotic of choice in Southern rap circles that was most famously celebrated by Three 6 Mafia and Pimp C's group Underground Kingz in the 2000 single "Sippin' on some Syrup."

The coroner's office said Pimp C had sleep apnea, which causes people to stop breathing for up to 30 seconds at a time while sleeping. That illness combined with large amounts of prescription-strength cough syrup is what killed the rapper, the coroner's Capt. Ed Winter said.

DJ Screw, another influential figure in the Texas hip-hop scene, died of a heart attack in 2000 after a reported overdose of codeine-laced cough syrup.
Pimp C, born Chad Butler, was 33 when he was found in his bed Dec. 4 at the upscale Mondrian hotel in West Hollywood. The coroner's office said his body was decomposing when it was found.

With partner-in-rhyme Bun B, Pimp C was half of the pioneering Port Arthur, Texas-based rap duo UGK. The group's self-titled CD topped the Billboard charts last year. Pimp C had been working on a solo effort before he died.

Advice for those who need to use recreational drugs:
Use safe, legal ones in moderation.

Browse for related stories in the index at the very bottom of this page, or read a self-administered prescription drug overdose story.

Thanks to the Associated Press for the source story today.

Sunday, February 3, 2008

Fast cash: Adverse effects of drug trials on human guinea pigs

Journalist Carl Elliott interviewed several human guinea pigs for a story in the New Yorker. One Iraqi man, living in Canada, began doing trials when he emigrated to Canada. He was living in a hostel and needed money to buy a car. A friend told him, "This is fast cash." When he enrolled in an immuno-suppressant trial at a Montreal-based subsidiary of SFBC, he found himself in bed next to a subject who was coughing up blood. Despite his complaints, he was not moved to a different bed for nine days. He and eight other subjects later tested positive for tuberculosis.

A human guinea pig in another drug trial had an even grimmer outcome. Traci Johnson, a previously healthy 19-year old student, committed suicide in a safety study of Eli Lilly's antidepressant Cymbalta in January, 2004. (Lilly denies its product was to blame.)

Alan Milstein, a lawyer in Philadelphia who has represented several human subjects, says about human guinea pigging: "This is not something you or I do. This is something the poor do so that the rich can get better drugs."

Advice to human guinea pigs: Read the fine print carefully to learn your rights.

Browse for related stories in the index at the very bottom of this page, or read another human guinea pig story.

Thanks to Carl Elliott for the source story in the Jan. 7 issue of the New Yorker.

Saturday, February 2, 2008

If he'd give me a few good years, I'd work on hospital-acquired infections

Bill Percival of Greenville, South Carolina picked up five staph infections while in a hospital for cancer treatment. As he clung to life, he made himself a promise.

"I told my doctor that if he would give me a few good years, I'd spend them working on hospital-acquired infections," said the 64-year-old retiree.

He kept his word. Since his recovery, he has spent the past few months attending meetings of a group overseeing the reporting of such infections.

On Friday, the S.C. Department of Health and Environmental Control released its first report showing rates at hospitals around the state for two types of infections — those associated with the placing of a catheter deep into major blood vessels, and those associated with surgical sites. In this first report, the latter category includes only heart-bypass surgeries and hysterectomies.

DHEC will collect more data and will issue another report later this year. Other procedures will be added to the reports over time so the public can have an idea of how a hospital is doing overall.

"In the long run, we hope that we get the reports to the point that they are a useful guide to healthcare consumers so that you can look and see where you're more likely to be safe if you have to go in a hospital," said S.C. consumer advocate John Ruoff, who lobbied for the infection-reporting legislation.

"People need to be knowledgeable about this, and if these reports can increase public awareness of the danger of health care-associated infections, antibiotic-resistant infections in hospitals and in the community, that is a big help," said Helen Haskell, who helped form Mothers Against Medical Error after her son died in a hospital.

Sen. Ralph Anderson, D-Greenville, lead sponsor of the infection-reporting bill, said the requirement will get hospitals to work harder to lower infections.

Dr. Shawn Stinson, who is in charge of clinical quality and patient safety at Palmetto Health, said, "I have kids, and if they get sick and end up in somebody else's hospital, I want zero."

Advice: Join the efforts of citizens in many other states to file and pass state legislation to require the reporting of hospital-acquired infections.

Browse for related stories in the index at the very bottom of this page, or see a short video of one person’s hospital infection story.

Thanks to Czerne Reid for the source story in today's South Carolina state.com.

Friday, February 1, 2008

Two compatible pairs: Paired kidney exchange

Thanks to a new program, a Georgia man and a Bessemer, Alabama, woman who both expected to wait many years for kidney transplants received new organs. More than a year ago, they were the first patients to receive a paired kidney exchange that matches a patient who has a willing, healthy living donor — sister and fiancé, respectively, in this case — with another donor and recipient, forming two compatible pairs.

The donors and recipients: Recipient James Thorn Jr., 38, of Bainbridge, Georgia, and his sister, Cynthia Rayburn, 42, of Jefferson County; and recipient Dwana Lewis, 29, and her fiancé, Alex Caldwell, 40, both of Bessemer. In the exchange, Cynthia donated to Dwana and Alex donated to James.

This was the first such procedure performed at the University of Alabama. All patients were recovering well and are listed in Good condition, transplant surgeon Alex Hawxby said. The recipient patients James and Dwana were to be discharged from the hospital within a few days while their immune-suppressing medications were being adjusted.

In such a procedure, both pairs of patients initially are kept anonymous from each other. When admitted to the hospital, they are assigned to different nursing units, go to different pre- and post-operative areas and return to separate nursing units afterwards. Their families wait in different areas, also.

To prevent any possibility that one of the donors might back out of the operation at the last moment, all the patients are simultaneously put under anesthesia.
Matching the appropriate incompatible pairs is a complex undertaking that requires additional staff and operating rooms, and a carefully choreographed operating room process, according to Dr. Eckhoff, who is director of the UAB Division of Transplantation. "The UAB Transplant Program has committed considerable resources for this program because of its great potential to provide relief to many of our patients," he said.

National Kidney Foundation President David G. Warnock, who is director of the UAB Division of Nephrology, noted: "This development marks an important milestone in the ongoing growth of the UAB transplant program. It will broaden the choices of patients with chronic kidney disease who are needing living donors for transplantation."
Nationally, the number of donated kidneys coming from living donors has increased dramatically in the last decade, as kidney-failure patients realize that the number donors available through organ banks is not rising by much. Family members and other loved ones may want to volunteer to donate one of their kidneys, but frequently are turned down for medical reasons. Others are told they cannot donate to their relative or friend because they have tissue characteristics that are incompatible or because the patient's blood contains proteins that would cause the kidney to be rejected.

UAB transplant doctors hope the Living Incompatible Kidney (LINK) transplant program will reduce long waiting times and help ease the organ shortage. Dr. Hawxby said, "As many as a third of patients are incompatible with their potential living donors. With the new paired kidney exchanges through LINK, a donor freely offers a kidney to a stranger in order to get their own loved one transplanted by another donor with a reciprocal situation. Many dialysis patients are on our transplant waiting list, which is why that list now numbers more than 2,400, with waiting times for transplants of typically four to five years and sometimes more."

Several more paired kidney exchanges are being evaluated.

Drs. Hawxby and Mark H. Deierhoi led James' operation, and Drs. Devin Eckhoff and Harry Sun led Dwana's surgery.

Advice to those needing a kidney: Look into innovative programs of kidney exchange like this one.

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

Thanks to Hank Black of the University of Alabama for the source story.