A checklist for post-operative care: 25 minutes was too long

A 17-year-old girl, Mariah Edwards, had a routine tonsillectomy, with Fentanyl as a pain killer.  However, right after the outpatient surgical procedure, she stopped breathing, but no one noticed this for 25 minutes.  The only automatic monitors of her vital signs had been muted.  And no one saw her because a curtain had been pulled around the post-op bay.  She died days later from the lack of oxygen.  This tragedy could have been prevented with proper post-op monitoring and care.

Her family’s lawyers at Ross Feller Casey have posted online a free checklist of questions that patients or their advocates can ask beforehand to assure themselves that doctors and nurses will safely care for their family member.  This is particularly important because the first few hours after surgery are often the most risky due to the use of anesthesia, the delivery of pain medication, and other complications that can arise in the recovery room.

Don’t be shy about questioning credentials or asking about post-op care. You are putting your trust, medical health, and quite possibly your life, in the hands of these people, so it is absolutely appropriate that you want to know about their experience and what to expect in the recovery room. You can, and should, ask to talk to whoever will be participating in the operation. It’s not unreasonable to request to talk with the anesthesiologist, surgeon, and other members of the surgical team before any surgery is performed.

Remember, it is just as important to ask about what will happen after the surgery as it is to ask about the procedure itself. You can ask about anything that you find relevant to the operation and time spent in recovery. It’s a good idea to make a list of questions prior to surgery so that you don’t forget any.  Sometimes asking the right questions about post-op care can make the difference between a positive medical outcome and a tragedy.

Read another checklist story.  Thanks to Mario Cattabiani, the Director of Communications at Ross Feller Casey in Philadelphia and David Bernard of OutpatientSurgery.net for this story. 

YourCity.MD: A good way to give back

Joe Benza’s story: 

I’m an entrepreneur, with several successful businesses over the years.  My book called "Preventing Aids" published in 1985 by JALSCO, Inc.  is in 40 countries.  I also bought and sold Internet domain names as a rewarding hobby.  I come from a medical family:  I have a brother who’s a surgeon, and we have dentists, dental hygienists and a urologist in the family as well. 

My father had Parkinson’s, and his hand would shake a little.  He was a proud man, so he wanted medication to stop that from happening as he was very self-conscious.  He ended up getting leukemia, which was one of the rare side effects of taking his partiular drug.  My whole family missed it; we didn’t look at the drugs he was taking to see if the risk outweighed the reward; none of us looked.  The drug was somewhat controversial, and my Dad told me two of his doctors argued about the use of the drug.  One of the doctors stated the other doctor was getting a kickback or had a financial interest of some kind in prescribing the drug! 

Experiencing side effects, he was misdiagnosed by his doctors for four months, and then he passed away.  We were really angry but took on most all of the blame ourselves...at least, I know I did.

About a year and a half later, a business opportunity developed.  I’d realized that the name www.YourCity.MD was available as a Web domain name with the "Local" city names as well.  The Gannett company encouraged me to build the websites to help people like my Dad and my family.  They were prepared to collaborate with me on making YourCity.MD into a business. They ultimately bowed out, but I kept with it.  In light of what had happened to my father, it seemed a good way to give back to everyone else so they can avoid our guilt by using our free resources to make the best decisions for their own families.  

Today, we’re helping people in 100% of the USA to find good local doctors and the best healthcare information available.  We are the only "local" platform on the Internet in any industry with a national footprint. 

Read another entrepreneur’s entrepreneurial patient safety story.  Thanks to Joe for the interview, and to Joelle Caputa of CPR Communications for connecting us. 

An adverse drug reaction from Seroquel: This was a revelation

A story from Kaitlin Bell Barnett's book, Dosed:  The Medication Generation Grows Up:

This excerpt is about one of the book's main subjects, a fourteen-year-old boy named Paul who has been a ward of the Florida foster care system since being taken from his parents at age five because of abuse and neglect. At the time of this scene Paul has been taking the atypical antipsychotic drug Seroquel for several years after being diagnosed with bipolar disorder. He has recently been sent to the hospital with dangerously high blood sugar resulting from untreated diabetes. At the hospital, he was diagnosed with diabetes and told he must inject himself with insulin multiple times a day to keep his disease in check.

     [Paul was] not particularly stoic about the pain. The first time he had to give himself a shot, he nearly passed out - it hurt.  He couldn't do this three times a day for the rest of his life.  From then on, whenever he had to prick himself to check his blood sugar or inject himself with insulin, he felt a wave of sadness and defeat come over him.  So far, he'd been very good at manipulating his circumstances to suit his purposes, but diabetes seemed one thing he couldn't wiggle out of.  His alleged behavioral problems were finally under control, and at the residential psychiatric center at least he'd been able to spit out the Seroquel.  But failure to inject himself, everyone told him, would put his life in danger.  

     At some point, Paul's psychiatrist explained that his diabetes probably resulted from taking Seroquel.  Paul wondered why doctors would prescribe him a drug that caused another illness, but he figured at first that they knew what they were doing.  As he got a little older, he also made a connection between the diabetes and the other side effects of Seroquel that he disliked so much - the dry mouth, the cravings, the woozy, dizzy feeling.  Once when he had either forgotten to take his Seroquel the night before or his foster parents had forgotten to give it to him, he awoke without a dry mouth, and it occurred to him that maybe he could avoid that feeling if he didn't take the pills.  So he went a week without taking them.  He felt better, and saw that his blood sugar readings were more level.  Then, the morning after he'd gone back to taking the drug, he awoke with a dry, fat-feeling tongue and abnormal blood sugar again.  Finally, he understood the connection - and realized that maybe the diabetes was reversible if he stopped taking his medication.  This was a revelation.  As he'd understood it, he'd have to deal with the condition for the rest of his life.

     By the time Paul figured this out, he have moved away from the group home and was living in a different therapeutic foster-care placement, one chosen for him because the father was a nurse and could monitor his condition.  Both parents watched like hawks while Paul took his insulin and his Seroquel, nagged him to go out and get some exercise to lose weight and control his blood sugar, and monitored his whereabouts and his grades.  Later, he would see the discipline they imposed as beneficial, but for the moment he chafed at being stuck adhering to two different medical treatments he intensely disliked, one of which - the Seroquel - seemed to be maddeningly and needlessly causing the other.

     In time, with his diabetes under control, Paul was transferred to a more relaxed foster home where, now aged sixteen or so, he was put in charge of his own medication.   He stopped taking Seroquel altogether, and noticed himself shedding weight.  Eventually, his blood sugar problems disappeared, and his doctor told him he no longer needed insulin.  He felt vindicated.

     Read a story of a similar adverse drug reaction to the anti-psychotic drug Zyprexa on this blog.  Thanks to Kaitlin for this excerpt from her book, Dosed:  The Medication Generation Grows Up, and to Bethany Sales of Newman Communications for connecting us.

Adverse effects of an anti-depressant: A complete 180 degrees

The story of Peter Andrew Sacco, PhD:
I had a client I was seeing a couple of years ago who came to me after seeing a psychiatrist. The individual was diagnosed with obsessive compulsive disorder, generalized anxiety disorder, depression as well as aspects of personality disorders which included borderline personality disorder as well as dependent personality disorder. This client had been referred to me from a colleague/friend knowing I am a cognitive behavioural psychotherapist who also specializes in relationships, addictions, anger management and stress management. By the time I saw this client, they were in a suicidal state.

After doing a case history, I could not believe what I had witnessed. The client who was in their late 30's had no history of chronic or clinical depression and no history of personality disorders. Rating them based on global functioning and changes, I looked to major life events or changes in the last 6-12 months. Lo and behold, they had recently gone through a relationship break-up (not their choice), a recent career change (actually a better one, but one that was extremely stressful and they were learning on the job training) and some other familial upheavals. They never had a history of chronic depression, anxiety, obsessive-compulsive disorder (OCD) or violence of any sorts.

When I inquired as to when the depression and suicidal tendencies, as well as intense OCD and anxiety reached their highest levels, the answer was two weeks before coming to see me. They had been to see the psychiatrist who put them on anti-depressants, which they should not have been on for situational depression/grief, and these meds had provoked not only greater episodes of depression, but psychotic thoughts as well. The client (the responsibility falls on them for this aspect) was consuming alcohol while on the wrongfully prescribed meds. Upon getting off the meds, engaging in cognitive behavioural counselling (CBT) and stopping their consumption of alcohol, his mood state did a complete 180 degrees!

Peter Andrew Sacco, Ph.D., is a psychology professor and author of Sweet Acceptance Vs Bitter Resistance. You can email him at psacco1@cogeco.ca.

For professional patient advocacy stories in mental health, see Chapter 6 of Ken Farbstein's book, Getting Your Best Health Care: Real-World Stories for Patient Empowerment. Thanks to Monica Foster and Nicola Williams of Ascot Media Group for setting this up.

The 18-month-old developed breasts: Complementary medicine

Dr. Lester Hartman's warning:

Cautions on herbal medicine in the hands of unqualified people: Remember "Ma Huang," also known as ephedra [which was banned by the FDA in 2004]. I saw kids taking this stuff "for energy" and come in shaky and hypertensive [with high blood pressure]! I had one mother use some type of "benign" Evening Primrose oil, only to have her 18-month-old baby develop breasts, as it contained estrogen. Remember Foxglove gave us Digitalis, and when a doctor played around with it he discovered that at a certain dose the patient’s leg swelling went away – but a higher dose, and the patient died….


Read another story about dangers of non-prescription medicines. Thanks to Dr. Lester Hartman as the source.

I CAN'T TASTE ANYTHING: Zicam Cold Remedy Nasal Gel

Charlene's friend’s story:
I want my friends and loved ones to know what has happened to me in hopes that it will never happen to you or anybody you care about.

About 10 days ago, I felt a cold coming on; so before I went to bed I used Zicam Cold Remedy Nasal Gel. It's supposed to help you "get over your cold faster." Immediately after I sprayed it into each nostril I felt the most horrific burning sensation imaginable. It literally felt like I had sprayed pepper spray directly into my brain. It burned all the way to the top of my skull. Mynasal passages swelled, my eyes watered – the burning lasted all night long into the next day. 
 


After about a day, I realized I couldn't taste anything and I thought, "Wow - I must really have a bad cold." Then I noticed that I couldn't smell coffee brewing, couldn't smell my perfume when I put it on, couldn't smell the popcorn I burned, couldn't smell my favorite candle. Ipanicked and starting smelling everything that I could find that had really strong odors – ammonia, finger nail polish remover, bleach, etc. I couldn't smell ANYTHING!

I started tasting everything that had really strong tastes such as HOT salsa, raw red onions, Doritos, coffee. I couldn't taste ANYTHING! 
 
I told my mother about this and she said, "Oh, I've heard Zicam can affect your Olfactory nerve."

I went online, typed in "Zicam side effects" and bam - up popped all sorts of web sites with people reporting the same thing I experienced. It seems that this past June, Zicam pulled the swabs for adults and children off the shelf but not the nasal gel. 
 


I went to my ENT and he said the Zicam had basically "FRIED" my Olfactory nerve and the results are most likely permanent. He put me on a strong dose of a steroid called Prednisone in hopes of recovering ANY bit of the nerve damage but he told me to "take this and pray." He said he had read about the side effects of Zicam and couldn't believe it is still on the shelf. It isn't FDA approved.

I am taking the Prednisone and praying but nothing is happening. I LITERALLY CANNOT SMELL OR TASTE ANYTHING! I can tell if foods are hot or cold, I can tell the consistency and I can faintly detect if it is salty but that is it. 
 


PLEASE, PLEASE, PLEASE pass this on to everyone you care about. I don't want this to happen to ANYONE else!!!!!!!!!! And if you have Zicam in your medicine cabinet—THROW IT AWAY!

Read the FDA Advisory.

Read a story about a very different kind of treatment for a nasal condition. Thanks to Charlene Casucci for sharing this story.

You wouldn't think she needed surgery: Death from breast augmentation surgery

Stephanie Kuleba had a charmed life: captain of the varsity cheerleading squad at West Boca High School in Florida, a near-perfect grade-point average, Barbie-doll looks and a ticket to the University of Florida, where she hoped to start her journey toward becoming a medical doctor.

Her friends said she was "perfect," so when Stephanie died Saturday of complications from breast augmentation surgery, none of them could understand how the girl whose success in life "was a sure thing" could perish in such a strange and devastating fashion.

"She was a role model for a lot of people," said friend and classmate Vicky Goldring, 16. "She was incredibly smart. She wanted to help people. She was just a happy 18-year-old girl."

While no official cause of death was released by authorities or Stepanie's family, many of her friends said she suffered a severe reaction to anesthesia given to her during a breast augmentation procedure Friday night.

Paramedics were called to an outpatient surgery center in Boca Raton, Florida, and rushed her to a nearby hospital, where she died Saturday.

With her long blonde hair and shy smile, Stephanie charmed people from an early age, friends said. A talented athlete, her path toward cheerleading began with competitive gymnastics. At 11, she had placed first all-around at a gymnastic invitational event in Tampa, competing in bars, beam, floor and vault events.

She had brains to match her beauty, friends said, earning a GPA above 4.0, acing advanced placement courses and earning an acceptance letter from the University of Florida, where she planned to head after graduation, imagining a career as a doctor.
"If you knew her, you wouldn't think she needed that [surgery]," said a friend. "She's perfect."

In recent years, doctors have been performing an increasing number of procedures such as breast implants, liposuction and tummy tucks on young women and even girls as young as 14.

The enormous popularity of reality TV shows like Extreme Makeover have fueled the desire of adolescent girls to alter their bodies permanently, and they are finding more surgeons willing to oblige them. Breast implants and liposuction are now bestowed by parents as graduation or birthday gifts. Some doctors say they have performed breast augmentations on Baby Boomer mothers and their teenage daughters. From 2002 to 2003, according to the American Society for Aesthetic Plastic Surgery, the number of girls 18 and younger who got breast implants nearly tripled, from 3,872 to 11,326.
Among all age groups, cosmetic implants have skyrocketed in popularity, according to the American Society of Plastic Surgeons. Last year, according to the ASPS, about 247,000 women got implants for augmentation, compared with 32,000 in 1992.

Anesthesia is a way to control pain using medication. In rare cases, an allergic reaction to local or general anesthetic can create health risks or even cause death.

Advice to people thinking of surgery at outpatient centers: Ask who’ll give the anesthesia.

Read another breast augmentation story.

Thanks to Kevin Deutsch for the source story in the March 24 issue of the Palm Beach Post.

The FDA had violated its own policy: Adverse drug reactions from defective heparin

Baxter International announced recently that it is recalling virtually all its heparin products. Baxter makes and sells more than 500,000 multi-dose vials of heparin in the U.S. each month. Heparin is used to prevent blood from clotting during dialysis and some common forms of heart surgery.

More than 400 adverse reactions have already been reported in the US from the use of heparin, including up to 21 deaths. Investigators are trying to identify the root cause, which seems related to the practices of small Chinese suppliers of crude heparin.

To make heparin, workers collect and cook the mucous membrane from the intestines of slaughtered pigs, producing crude heparin. Major producers refine that and sell it to Baxter and others, which make the finished product for use in hospitals.

Blue ear pig disease has swept through China, depleting stocks, and leading some farmers to sell sick pigs. This led companies to switch to using small, often unsanitary and unregulated village workshops as less expensive suppliers. As much as 70% of China’s crude heparin now comes from such small factories in poor villages.

The FDA had admitted this month that it had violated its own policy by failing to inspect Changzhou SPL, located west of Shanghai, before the factory began shipping crude heparin, an ingredient of the medicine heparin, in 2004. The Chinese government does not inspect such factories.

Advice to heart surgery and dialysis patients: Ascertain, or ask your patient advocate to ascertain, the source of the heparin you will receive. A sufficient supply is available from safer suppliers.

Browse for related stories in the index at the very bottom of this page.

Thanks to Walt Bogdanich and David Barboza for the two source articles in last week's NY Times.

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.

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.

Managers threatened to have them deported: Human guinea pigs

The most notorious recent disaster affecting healthy human "guinea pigs" took place in March 2006, at a testing site run by Parexel at Northwick Park Hospital, outside London. Parexel offered human subjects 2,000 British pounds to enroll in a Phase I trial of a monoclonal antibody, a possible treatment for rheumatoid arthritis and multiple sclerosis. Six human subjects required care in the Intensive Care Unit (ICU) after suffering life-threatening reactions, e.g., severe inflammation and organ failure. They were hospitalized for weeks. One subject's fingers and toes had to be amputated. All of them have long-term disabilities.

It's not clear whether Parexel is paying for the required health care for the injured human subjects. At least some contract research organizations do not do so.

SFBC International offers one such example. It conducted a two-month study of the pain medicine Palladone, offering subjects $2,400. SFBC reserved the right to penalize subjects whom it dropped from the study because of the drug's side effects. SFBC (now known as PharmaNet Development Group) paid their human subjects most of their compensation only after they completed all four of the study's confinement periods. When its undocumented immigrant guinea pigs talked to the press, managers threatened to have them deported, according to Bloomberg Markets. PharmaNet settled a lawsuit for $29 million in August.

Advice to those considering whether to be human subjects in clinical drug trials: Read other guinea pigs' stories first.

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

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

When I play, it feels like a massage: Synesthesia as an adverse drug reaction

Prof. Sherrilyn Roush woke up one morning seven years ago to discover that the left side of her body had gone numb, with a stroke. The day before, she had taken a prescription decongestant with ingredients that were suspected of causing strokes in young women. The decongestant had caused a lesion the size of a lentil in her mid-brain. Five months later, the Food and Drug Administration took the drug off the market.

Sherrilyn did not realize that her stroke would lead to sensations that few people had ever experienced. She began to feel tingling on her body in response to sounds. Today, more than ever, she feels sounds on her skin.

The first time it happened, she heard the voice of an announcer on a local FM station. "I felt an unpleasant sensation on my left thigh, left arm, the back of my shoulder and even the outside of my left ear. It was the kind of icky feeling that uniformly washes over you at a scary movie,"she said. "I had to stop listening. It made me cringe."

Psychologists at Rice University have tested her over the last seven years, observing how her brain's wiring has reorganized. Their article appears in the November issue of Annals of Neurology. They call her brain’s odd mixing of the senses "acquired synesthesia," and attribute the rewiring to the stroke.

Some sounds set her teeth on edge. Others evoke pleasant feelings on her skin. The soft sound of water bubbling is "soothing, almost like a massage on my skin."

Recently, she learned how to exploit her oddly mixed up senses. "I took up the string bass," she said. "Most people get pleasure from this instrument. It is huge. It has a soft deep sound. But I get more pleasure from this instrument, right here in my left arm. When I play, it feels like a massage."

She has learned to exploit the effects of her condition, in a way reminiscent of patients whom the neurologist Dr. Oliver Sacks described in "The Man Who Mistook His Wife for a Hat." Indeed, Sacks found that music had an exceptional power to help that severely disabled man to anchor himself in the world.

Advice to people who are greatly affected by their disease: Look for innovative ways to make the best of your disease, as Sherrilyn has.

Browse for related stories in the index at the very bottom of this page, or read a story of a patient-entrepreneur who made the best of her disease.

Thanks to Sandra Blakeslee for the source article in the Dec. 25 issue of the NY Times.

Like a bartender who serves a drunk customer: The physician's liability for drug side-effects

David Sacca, 75, was a very sick man, with emphysema, high blood pressure, and metastatic lung cancer. He was taking oxycodone, Zaroxolyn, prednisone, Flomax, potassium, Paxil, oxazepam, and furosemide – some of which can cause drowsiness, dizziness, and fainting.

While driving in Spring 2002, David passed out and drove off the road, hitting and killing a ten-year-old boy, Kevin Coombes, who had been standing on the sidewalk with a friend.

Yesterday the Massachusetts Supreme Judicial Court ruled that David's doctor could be sued for failing to warn his patient about the side effects of the drugs and for failing to warn him of the danger of driving while under the drugs' influence.

In writing the court's lead opinion, Justice Roderick Ireland compared the doctor's liability to that of a bartender who serves a drunk customer.

Almost every drug has side effects. Drowsiness is a common side effect of many prescription drugs. This ruling greatly expands physicians' liability for the prescriptions they write every day.

Advice: Ask your doctor and pharmacist about the likely side effects of your drugs.

Browse for related stories in the index at the very bottom of this page, or read a story of the sad consequences of a different kind of expectable side effect, from Zyprexa.

Thanks to Liz Kowalczyk for the source article in today's Boston Globe.

I danced around the truth to make the drug reps happy: Effexor and its side effects

The Story of "Dr. Drug Rep:"

On a blustery fall New England day in 2001, a representative from Wyatt Pharmaceuticals came into my office and made me an offer I found hard to refuse. He asked me if I'd like to give talks to other doctors about using Effexor XR for treating depression. I'd get $500 for one-hour "Lunch and Learn" talks at local doctors' offices, or $750 if I had to drive an hour.

I had a busy private practice in psychiatry, specializing in psychopharmacology. I was quite familiar with Effexor, since I had read recent stories showing it might be slightly more effective than Prozac, Paxil, Zoloft, and other selective serotonin reuptake inhibitor (SSRI) anti-depressants.

I [agreed and that year I] made about $30,000 in supplemental income from these talks.

[A question from the audience of one of the talks I gave made me realize that] I was willing to dance around the truth in order to make the drug reps happy. Receiving $750 checks for chatting with some doctors during a lunch break was such easy money that it left me giddy. Like an addiction, it was very hard to give up.

I had not lied – I reported the data exactly as they had been published. But still, I had spun the results of the study in the most positive way possible. I realized that in my canned talks, I was blithely minimizing the hypertension risks of Effexor. There was another problem: one of Effexor's side effects. Gradually it became clear that there were "withdrawal" symptoms.

A recent study found that one-fourth of U.S. doctors receive drug money for lecturing to physicians or helping market drugs in other ways.


To his credit, Dr. Carlat now publishes a medical education newsletter for psychiatrists that critically assesses drug research and marketing claims. The newsletter is not funded by the drug industry.

Doctors want to learn about the most recent drugs so they can help patients, and they more readily believe other doctors than laymen drug reps. Doctor may know best, but money talks.

Advice: Ask your doctor's office manager if the doctor gets money from a drug company.

Browse for related stories in the index at the very bottom of this page, or read an Effexor misuse story.

Thanks to Dr. Daniel Carlat for the source article in today's New York Times Magazine.

Each widow will get $72,000: Merck's settlement for Vioxx adverse drug reactions

Merck will pay almost $5 billion in a settlement with the 27,000 plaintiffs. Each plaintiff who took Vioxx for a month or more, and had a heart attack or stroke within two weeks of taking Vioxx, will get an average of $120,000. When attorney's fees are subtracted, each plaintiff will wind up with an average of only $72,000.

Yale Law School Professor Peter Shuck says Merck "played hardball, and the settlement reflects that. The predicted liabilities for them were much, much higher."

Dr. Eric Topol agrees: "They've gotten off quite easily for the problems they've engendered," said the co-author of an important medical journal article warning of the risks of Vioxx.

Advice for users of Vioxx: Ask a lawyer for advice. You don’t necessarily need to accept the settlement, but note that most people who sued Merck individually have lost.

Read the story of a successful Vioxx plaintiff, or read more from the source article by Alex Berenson in today’s New York Times.

Mother was convinced psychiatric meds were poison: Adverse drug reaction of diabetes

"Shyla" was a shy patient who ate nothing but white foods, and assaulted anyone who entered her airspace on the hospital ward. She was mute, but not uncommunicative. Some of her problem was her psychosis. Most of it was her mother, who was appointed by a court to be Shyla’s legal guardian and to monitor her medications. But her mother was convinced that psychiatric medications were poison. So Shyla would go home on weekend passes and return with all her pill bottles untouched, and without a shred of sanity.

This continued for months. Her mother brought a notebook to each visit that listed the side effects. Shyla’s doctors thought her mother was sadistic; she thought the doctors were evil experimentalists.

The doctors successfully persuaded a judge to remove the mother as a guardian and appoint someone else.

The guardian ensured Shyla took her meds. At first, Shyla flourished; she smiled, spoke, became lucid, joined a day program, began overnights in a residential house and was discharged. She seemed happy.

Then she got diabetes and required insulin. By then, studies had consistently found a link among her condition, antipsychotic medications, and diabetes. In 20/20 hindsight, it was clear that she had had an adverse drug reaction to the antipsychotic drugs . Her mother had been right.

As her doctor, Elissa Ely, concluded, "We doctors were innocent but at fault. The ground beneath professional feet should grow firmer over time – one ought to feel more certain of what one knows. But the more I know, the more I am afraid."

Advice: Have a healthy fear of possible side-effects, and use only the least amount of drugs to be effective.

Read Dr. Elissa Ely’s article in the July 24 NY Times.

Keep it inside the locker room: FDA drug safety reviews

Congressional investigators and the New York Times have identified at least five reviewers at the Food and Drug Administration (FDA) who have recently been disciplined for uncovering evidence about the dangers of certain popular drugs. They include: Dr. Rosemary Johann-Liang, for her investigation of the diabetes drug Avandia; Dr. Andrew Mosholder over anti-depressants; Dr. David Ross over the antibiotic Ketek; and Dr. Victoria Hampshire over her review of heartworm medicines with fatal effects on more than 500 dogs.

Dr. Hampshire describes a "feeling of fear" among reviewers at the FDA. The FDA Commissioner, Andrew C. von Eschenbach, has urged the safety officials to keep disagreements "inside the locker room," and said those who discussed findings with outsiders would be "traded from the team." Indeed, Dr. Hampshire’s work in uncovering the dangers of heartworm medicine led to her being disciplined and being made the subject of a criminal investigation.

Secrecy by the FDA blocks patients from empowering themselves. And if the FDA does not adequately guard us from dangerous drugs, we have to be more vigilant.

Advice: If you’re prescribed Ketek or Avandia, ask your doctor about adverse reactions. Ask your vet about adverse drug reactions from your dog’s heartworm medicine.

Read another of our Avandia stories, or read Gardiner Harris’ source story in today’s New York Times, "Potentially Incompatible Goals at FDA."

It took 17 days for the lab results: An adverse drug reaction

A grandmother died from liver failure after an adverse reaction to a drug, an inquest ruled today.

Sheila Gunn, age 69, died less than seven months after being prescribed Aulin, which contains Nimesulide. The medication was recently ordered off the shelves by the Irish Medicines Board.

Three other people are believed to have died from liver failure after taking the drug, with six others needing liver transplants.

Sheila had been diagnosed with osteoarthritis in July 2003 at a Dublin hospital. She was first prescribed the maximum recommended dose of Aulin - 100mgs twice a day - by her general practitioner and had collected six repeat prescriptions. Seven months later, at another hospital, a routine blood test showed significant liver function abnormalities; it took 17 days for the lab to return the results to the clinic.

She was later moved to another hospital where she was diagnosed as suffering from an adverse reaction from Aulin. She was transferred to the intensive care unit, and died there five days later.

Her daughter, Marcia O'Hara, welcomed the ruling by the Dublin City Coroner, saying she hoped her mother's death would prevent another person from losing their life to the drug.

Advice: Make sure you get your lab results back promptly.

Read another of our stories about delayed lab results, or read the Irish Times’ source story.

Three days later, he was fine: Adverse Drug Reaction - Avandia

[Translation appears below]
A 70-year-old man with hypertension and chronic renal insufficiency presented with dyspnea, orthopnea, and paroxysmal nocturnal dyspnea. Metformin had been replaced with rosiglitazone, 4 mg/d, 1 month previously. The patient had no history of congestive heart failure. Physical examination revealed tachypnea and bilateral lower extremity edema. Chest radiography showed cardiomegaly with bilateral basilar infiltrates. Transthoracic echocardiography revealed left ventricular hypertrophy and diastolic dysfunction but normal LVEF. The serum digoxin level was slightly increased at 2.3 ng/mL. Serum creatinine values did not change. Rosiglitazone was discontinued, and intravenous furosemide was administered. Metoprolol, digoxin, minoxidil, and verapamil were replaced with losartan and felodipine. After 3 days, the patient was asymptomatic.

Translation: A 70-year-old man with high blood pressure and bad kidneys came to the hospital because he had a distinctive kind of rapid and labored breathing. Examination and test results showed he had an enlarged heart, and feet swollen with fluid. He had started taking Avandia a month earlier. Though he had no congestive heart failure before the Avandia, it looked like he was getting it, or another serious heart problem. In the hospital, doctors took him off Avandia. Three days later, he was fine.

He was one of millions of patients taking the highly profitable drug.

Two days ago, researchers published an article in the prestigious New England Journal of Medicine that reviewed 40 earlier studies on the subject, and discovered that users of Avandia (thiazolidinedione) got 40% more heart attacks than other diabetic patients who were not taking it.

In one of these studies, quoted above, Dr. Asra Kermani and his co-authors “conclude that thiazolidinediones can cause pulmonary edema or exacerbate heart failure. Thiazolidinediones should be used with caution or avoided in patients with left ventricular dysfunction or chronic renal insufficiency.”

Advice to people with diabetes: Discuss with your doctor what to do. There may well be alternative drugs, not to mention other alternatives like exercise, diet, etc.

Read another of our adverse drug reaction stories, or read Stephanie Saul’s story in Tuesday’s New York Times.

They didn’t warn her, the jury said: A menopause drug lawsuit

Merle Simon had taken Provera for ten years. The New Jersey woman was one of as many as six million women who took the pills to treat menopause symptoms such as hot flashes and mood swings before a 2002 study by the National Institutes of Health that highlighted the drug’s link to cancer.

She has just won a lawsuit against Pfizer, which now owns Upjohn, the company that made Provera. In awarding her $1.5 million, the jury said the drug maker had failed to adequately warn her of the risk of invasive breast cancer. Merle took Provera starting in 1992, her lawyer, Jim Morris, told jurors. She stopped taking the drugs after being diagnosed with breast cancer in 2002, he said.

Advice to women nearing menopause: Carefully consider the risks and benefits before starting hormone replacement therapy. Useful background information appears here.

Read another of our stories, about the beneficial use of hormones, or the source story in today’s Boston Globe.