January 25th, 2011
By: Neil Katz
Dr. Andrew Wakefield is either the victim of “a ruthless, pragmatic attempt to crush any attempt to investigate valid vaccine safety concerns” as he describes it or a huckster paid by lawyers in 1998 to falsify an autism study to make it appear vaccines were to blame for the disorder. The lawyers later sued the vaccine makers.
The huckster version of events is described in a British Medical Journal piece released this month which rips apart Wakefield’s study and his motivation for writing it.
“Such clear evidence of falsification of data should now close the door on this damaging vaccine scare,” said BMJ’s editor-in-chief Dr. Fiona Godlee in a statement.
The 1998 study, which appeared in the prestigious British journal the Lancet, was groundbreaking when it came out. Wakefield examined 12 children with regressive autism – they were developing normally and then went awry. Wakefield said their symptoms appeared soon after receiving a vaccination for measles mumps and rubella called an MMR. In rich nations, almost all children receive the shot.
Wakefield, a gastroenterologist, hypothesized that the vaccine caused both the autism symptoms and gut problems.
Parents with autistic children, desperate to find it’s cause and a cure, quickly rallied around Wakefield’s study. Vaccination rates dropped in Britain as well as the United States. New cases of measles rose.
And so did the cases of autism or at least its diagnosis.
Later studies tried to replicate Wakefield’s findings, but could not. Debate raged about the root causes of autism.
But the BMJ investigation by journalist Brian Deer found that five of the 12 children in Wakefield’s paper had symptoms before the MMR shots. One girl turned out to have a heart disorder. Her symptoms disappeared after it was treated. The report claims three of the children turned out to not have autism at all and only one was eventually diagnosed with the regressive form of it described in Wakefield’s paper.
The report also alleges that Wakefield falsified timeliness and when investigators showed Wakefield’s study to parents of the children involved, some claimed he misrepresented their stories.
Perhaps most damagingly, the report claims Wakefield developed his autism vaccine theory only after he was hired by lawyers planning to sue vaccine makers. BMJ claims he was paid more than half-a-million dollars for his efforts.
On Wednesday, Wakefield fired back. Speaking to CNN’s Anderson Cooper, he claimed the report’s author was “a hit man who has been brought in to take me down” by big pharma.
According to the network, Deer signed a disclosure form claiming he has no financial interest in the matter, but freely admits he was paid by BMJ for his reporting.
“That’s what journalists do,” he told CNN.
Last year, the Lancet formally retracted Wakefield’s study. Ten of the 13 authors had earlier done the same. Wakefield has since been stripped of his medical license in Britain.
But for Wakefield’s supports, the battle drags on.
“I cannot imagine for a second that Dr. Wakefield would have any reason to falsify data,” Wendy Fournier, president of the National Autism Association, told CNN. “He’s a man of integrity and honesty and truly wants to find the answers for millions of children who have been affected by autism.”
December 28th, 2010
By: Amy Chaves
The November 2010 issue of Nature reported that several large pharmaceutical companies, including AstraZeneca and GlaxoSmithKline, have chosen to pull out of the psychiatric pharmacology in the treatment of schizophrenia. The reason is obvious, according to Nature author, Abbott: The first generation of schizophrenia drugs (manufactured in the 1950s) and the second generation (manufactured in the 1990s) have not addressed the adverse side effects of antipsychotic drugs on patients.
The World Health Organization (WHO) recognizes schizophrenia as a mental disorder that interferes with a person’s ability to identify what is real. A person affected with this disorder is not able to manage emotions, cognition, as well as communication. Symptoms could appear in early adolescence as “early flickers of paranoia, hypersensitivity, and hallucination” (Dobbs, 2010). According to WHO, schizophrenia is usually characterized by disruptions in the most fundamental human attributes such as perception, language, thought, emotion, and sense of self. In 2001, WHO estimated that schizophrenia affects 7 per thousand of the adult population (the equivalent of 24 million worldwide), mostly between 15 to 35 years old.
The same November 2010 issue of Nature discussed about a US clinical trial involving nearly 1,500 patients in 57 clinical sites, and at a cost of US$43 million. This trial examined an array of second generation antipsychotic drugs to determine if they were better than the first generation antipsychotic drugs. The clinical trial spanned from 2001-2005. When the results of the unblinded trial were released in 2005, the psychiatric community and pharmacological companies were astounded: the findings suggest that the new drugs were barely different from the old ones.
Although both generations of anti-psychotic drugs were reported to control hallucinations and delusions, patients taking the second generation drugs remained confused, withdrawn, and devoid of drive, the same side effects observed in the first generation drugs. The result of this clinical trial, according to psychiatrist Jeffrey Lieberman, is frustrating and humbling for the research community and it had a chilling effect on the pharmaceutical industry (Abbott, 2010).
A systematic review in 2003 by Bagnall, et al., examined the effectiveness, safety, and cost-effectiveness of atypical antipsychotic drugs used to treat schizophrenia. The review consisted of 171 randomized, controlled trials, of which 28 were from drug manufacturers. Although the review showed that atypical drugs (i.e., risperidone, amisulpride, olanzipine, and clozapine) were seen to be more effective in relieving symptoms of schizophrenia than typical ones, it nonetheless found the following common side-effects: agitation, movement disorders, impotence, dry mouth, nausea and vomiting, dizziness, and weight gain.
The same systematic review examined the safety of these drugs and some of the following adverse reactions were found: death, malignant syndrome, seizures, hepatic dysfunction, and cardiac problems.
A systematic review, involving the application of scientific strategies to limit bias, is a synthesis of relevant studies that address specific clinical questions. Reviews of this kind are considered as the best evidence for making clinical decisions.
The findings of the 2001-2005 US clinical trial and the systematic review of Bagnall, et al. point to the ineffectiveness of anti-psychotic drugs in dealing with schizophrenia. Considering that up to 1% of the world’s population is estimated to be affected by this disorder, schizophrenia represents a huge market for any pharmaceutical. However, as research have shown, the pharmaceutical industries have done little in 50 years to address the adverse side-effects that patients have experienced from antipsychotic drugs .
August 30, 2010
Gene detectives on Sunday announced they had found the first inherited link to common types of migraine, a finding that boosts hopes for new drugs to curb this painful and costly disorder.
Scientists from 40 medical centres pored over the genetic profiles of more than 50,000 people, comparing those who suffered badly from migraines with others who were otherwise healthy.
What came up in the net was a tiny but telltale variant of DNA that boosts the risk of getting migraines by around fifth.
“This is the first time we have been able to peer into the genomes of many thousands of people and find genetic clues to understand common migraine,” said Aarno Palotie, head of the International Headache Genetics Consortium at Britain’s Wellcome Trust Sanger Institute, which led the study.
Previous research has found links for some extreme, but mercifully rare, forms of migraine, but this is the first to pinpoint an association for common types of the disease.
The tiny genetic variant, or allele, is called rs1835740.
Lying on Chromosome 8 between two genes, PGCP and MTDH/AEG-1, it allows a messenger chemical called glutamate to accumulate in junctions between brain cells, and this unleashes the migraine, the scientists believe.
If so, drug engineers have a tempting target in preventing glutamate buildup, they hope.
The paper, published online in the journal Nature Genetics, cited figures that migraine affects 17 percent of European women and eight percent of men.
The UN’s World Health Organisation (WHO) ranks migraine in the top 20 diseases in terms of “years lived with disability,” a benchmark of handicap. A US estimate put migraine’s economic cost on a par with diabetes.
The study first compared the genome of more than 3,000 migraine sufferers in Finland, Germany and the Netherlands against that of some 10,000 non-sufferers.
These results were then compared in a second phase with the genomes of a second batch, comprising 3,000 migraine patients and more than 40,000 otherwise healthy people.
The study found rs1835740 to be one of several connecting genetic cogs in regulating glutamate levels.
The allele alters the MTDH/AEG-1 gene, which in turn affects a gene called EAA2.
The EAAT2 gene controls a protein that is responsible for clearing glutamate from the brain synapses. This protein has previously been linked with epilepsy, schizophrenia and various mood and anxiety disorders.
The authors say further work is needed to confirm the findings and see whether other genetic culprits abound.
Patients in the study were recruited mainly from specialist headache clinics, which means they are likely to represent only the more extreme end of those who suffer from common migraines, said Gisela Terwindt of Leiden University Medical Centre, the Netherlands.
“In the future, we should look at associations across the general population, including also people who are less severely affected,” she said.
Migraine is believed to occur when inflammatory chemicals are released around the nerves and blood vessels in the head, inducing pain that can be excruciating. It is sometimes accompanied by nausea and hyper-sensitivity to light and sound.
Common migraines fall into two categories — those with an “aura,” or shimmering circle seen by the sufferer, and those without.
Sufferers tend to be aged 35-45, although the frequency and duration of the attacks can very widely.
August 23rd, 2010
By: Jerry Ulmer
Ten McMinnville High School football players remained hospitalized Saturday as they were treated for a rare soft-tissue condition after participating in an “immersion camp” at the school last week.
The players are suffering from “compartment syndrome” — soreness and swelling — that affects their triceps. They have received intravenous fluids to ward off a potential kidney disorder, according to Dr. Craig Winkler, who is treating seven of the players. Earlier Saturday, 12 players were at Willamette Valley Medical Center, but two were released by Saturday night, a spokeswoman said.
“The reason we’re treating these players so aggressively is to prevent renal disease,” Winkler said. “If it’s significant enough, it could actually end up in dialysis.”
McMinnville School District officials continue to investigate the cause of the condition. Superintendent Maryalice Russell said Friday that she didn’t believe the workout prescribed by first-year coach Jeff Kearin was excessive. The camp was in preparation for the first week of practice, which begins Monday.
Kearin has experience coaching in college, including at USC and UNLV, but a former colleague dismissed the idea that such a background could lead the Grizzlies’ coach to push high school players too far.
“He’s been an educator for a long time,” said Los Angeles Valley College coach Jim Fenwick, who worked with Kearin at Cal State Northridge. “He’s very conscientious about the high school development and the kids.”
Fenwick, formerly head coach at Eastern Oregon University in La Grande, said he offered Kearin, 50, a job as an assistant this season should he decide against taking a high school coaching job.
“He works well with kids,” Fenwick said. “His personality is not a big, hard-nosed, lineman’s mentality, or a weight-room-mentality guy.”
The players are being treated for high levels of creatine kinase, a protein that can harm the kidneys.
Doctors are keeping a close watch on the CK levels of the players, some of whom entered the hospital with levels higher than 42,000, well beyond the level of 3,000 needed before they are discharged.
Winkler said that “95 percent” of the players are responding well to treatment. One player is “not responding adequately,” though, and would be treated with more fluid to flush out his kidneys faster.
Dennis Nice was among the parents waiting at the hospital for reports on the CK levels. Nice and his wife Margaret — parents of Joshua, 17, and Daniel, 16 — have been at the hospital around the clock since Wednesday.
“It’s just a matter of time,” Dennis Nice said. “There’s nothing we can do about it. We’re just waiting for the numbers to drop. All the parents pretty much know each other now. We’re all supportive of each other.”
Daniel Nice was one of three players to undergo surgery to reduce swelling. His CK levels had dropped from 17,000 to 6,600 by Saturday, according to his father.
Junior Kyle Downing said he had slight swelling in his triceps Tuesday but it receded. He took a blood test as a precaution Thursday night, however, and it revealed a CK level of 18,000. It has dropped to 6,000 since he was admitted Friday.
The cause of the condition has school officials, parents and doctors puzzled. Winkler said most cases of compartment syndrome are due to trauma.
“We could only find like 10 documented cases of triceps compartment syndrome,” he said. “It’s very, very rare.”
Some have speculated that a workout that targeted the triceps, in a hot wrestling room at the school Sunday, could be the cause. But Downing, who has been lifting weights all summer, disagreed.
“It definitely wasn’t the workout. The workout was fine,” he said. “It was basically nothing. The complete triceps workout was about one minute. This is odd.”
Russell said Friday that she supports the coaching staff. Rene Downing, Kyle’s mother, said Saturday that “the kids are crazy about the coach. He’s a good coach.”
Kyle Downing said the team remains excited about the season.
“This is a speed bump for us,” he said. “This is definitely a big building block. This is adversity at its greatest. To all the teams we play, I’d have to say, ‘Watch out.’ ”
May 18, 2010
By Andrea Canning
A study published today in the Journal of Pediatrics says that one type of pesticide commonly used on fruits and vegetables may be contributing to Attention Deficit Hyperactivity Disorder, or ADHD. Researchers took urine from over 1,000 participants ages 8 to 15 and analyzed it for pesticides. 119 of the children had symptoms of ADHD. Those with the highest concentration of pesticides were more likely to have the disorder, according to the study.
“It’s consistent with other studies that have looked at organophosphate pesticides and have found that exposure of children to organophosphates in early life can cause brain injury. This study builds on those other studies,” said Dr. Philip Landrigan, chairman of the Department of Community and Preventive Medicine at the Mount Sinai
April 27, 2010
By Jason Ramsey
Adderall is a medicine that is prescribed for treatment of attention deficit hyperactivity disorder or ADHD.
According to the medication guide for Adderall XR, the medicine has detrimental side effects. These include heart related troubles such as sudden death in patients, who have heart problems or heart defects. It can also result in heart attacks and strokes in adults, an increase in blood pressure and heart rate.
Besides these physical side effects the medication also has an adverse impact on mental health. It can lead to worsening of behavior, problems in thinking, augment bipolar disorder or cause the disease, aggressive behavior in all patients.
In children and in teenagers, the medicine is linked with fresh psychotic symptoms such as hearing voices, believing in things that are untrue and suspicious or maniacal signs.
The Food and Drug Administration has issued a notice regarding the injurious side effects of stimulant medicines such as Adderall on cardiovascular health. The alert was issued on June 23, 2009.
The FDA also undertook a study on the impact of the drug on children. The primer data suggests that Adderall augment the risk of sudden deaths in this group.
However, the agency was not certain whether the drug lead to death in these cases. It has therefore stated that patients should not stop taking the medicines.
April 5, 2010
By Susan Donaldson James
Two North Carolina doctors have been reprimanded for performing a caesarian on a woman, only to discover she wasn’t pregnant at all.
The incident — a rare case of pseudocyesis or a false or hysterical pregnancy — happened at the Cape Fear Medical Center in Fayetteville, N.C.
The woman reportedly appeared at the hospital with her husband asking for a C-section. A resident in charge made the pregnancy diagnosis and doctors agreed to surgery after trying to induce labor for two days.
Neither doctor independently confirmed the pregnancy.
In January, after studying the case for more than a year, the North Carolina Medical Board sent “letters of concern,” the lowest level of discipline, to Dr. Gerianne Geszler, who was the on-call physician, and Dr. Dorrette Grant, who performed the caesarian in 2008.
When they saw an empty uterus, they “closed her back up,” Geszler told ABC News. Pseudocyesis can “fool people,” said Paul Paulman, assistant dean for clinical skills and quality at the University of Nebraska College of Medicine, “but you open someone’s abdomen, you make darn sure you know what you’re doing,” he said. “It’s a potentially life-changing event.”
Paulman wrote about a similar 1990 case in the Journal of Family Practice.
The medical board in North Carolina said the resident at Cape Fear Medical Center did not have enough experience to make the pregnancy diagnosis and doctors should have conducted their own exam.
Dena Konkel, assistant director of public affairs for the medical board, said the case was “unique.”
“The board was mostly concerned about the management of patient care,” she said. “It may have fallen below the standard of care.”
“Some would argue that this is not disciplinary in nature — it doesn’t limit their ability to practice medicine,” said Konkel. But, “it creates a public record, something that can be looked up and read about what happened.”
Neither doctor has been disciplined publicly before. Both still practice medicine, but with a warning from the board that similar complaints could lead to formal disciplinary proceedings.
Grant did not return calls from ABCNews.com, but the board’s Web site indicates she is still delivering babies at Women’s Health Haven Obstetrics and Gynecology.
“I do not want to criticize anyone else involved with this case,” said Geszler. “I was covering the residents when the patient arrived, and she reported the case to me. I did not actually see the patient as this is not necessarily a protocol that the attending examine the patient.”
Pseudocyesis Can Be Deceptive, Say Doctors
She said the ob-gyn resident was a medical doctor and trained in ultrasound.
“Residency and supervision of residents is very complicated,” said Geszler, who is now practicing at Breezewood’s Center for Health and Restoration. “To let them make appropriate evaluation and decisions, yet without harm to the patient. Do you second guess everything? Do you repeat everything?”
Other doctors familiar with pseudocyesis, say the disorder can be deceptive.
Although it is a psychiatric condition, women can have all the physiological symptoms of pregnancy — cessation of menstruation, distended abdomen, swollen breasts, morning sickness and food cravings, and even labor pains.
Pseudocyesis is considered rare, occurring at a rate of 1 to 6 for every 22,000 births. It often strikes women with a “strong desire” to become pregnant, according to Paulman.
“On face value, it’s bad care and unconscionable,” he said. “If I am a first-year resident, buried and swamped, working hard and that week I get a high amount of emotion from a family, I can see how the error was made. But it shouldn’t have happened.”
Pregnancy can be ruled out by an abdominal exam — “you can feel the unmistakable bony head” — or the rapid fetal heartbeat [120 beats per minute, unlike the mother's 70-80 per minute] or through a sonogram image, he said.
False pregnancies have been known throughout history, dating back to 300 B.C. when Hippocrates treated 12 women who were convinced they were pregnant.
The English queen “Bloody” Mary Tudor, the oldest daughter of Henry VIII, experienced pseudocyesis, perhaps because of her father’s reputation for beheading childless wives.
Sigmund Freud’s most famous patient, “Anna O,” believed she was pregnant with the child of her former psychiatrist, Josef Breuer, which led the father of modern psychiatry to expound on the theory of “transference” or attachment.
March 12, 2010
By Julie Steenhuysen
The studies, which would not have been possible a year or two ago, are the first real delivery of the promised transformation of medical science from the Human Genome Project’s mapping of the human genetic code.
One was also made possible by some of the $5 billion that U.S. President Barack Obama directed to the National Institutes of Health in September from the $787 billion economic stimulus package.
And in that study, the genetic researcher was himself one of the patients.
Dr. James Lupski of the Baylor College of Medicine in Houston has a recessive genetic disease called Charcot-Marie-Tooth syndrome. It affects the nerves stretching from the spinal cord to the arms, legs and feet.
Lupski has been experimenting on himself and his own family for years.
“We tried every other method for 25 years to find out which mutation was important,” he said in a telephone interview.
“With this methodology we were able to do it. This is the first time whole genome sequencing has applied to actually find the cause of a disease.”
Lupski had been taking blood samples from his grandparents, parents and siblings for years. He got close but the research was considered too risky for funding by the National Institutes of Health.
“He was only able to complete this study because of the stimulus money that we got,” said Dr. Story Landis, director of the National Institute of Neurological Disorders and Stroke.
Her institute designated Lupski’s project for about half a million dollars of the money that Obama directed to the NIH.
Lupski’s team used a gene sequencer from Carlsbad, California-based Life Technologies to read the entire DNA code in the samples from Lupski and three of his siblings who have the syndrome, his parents and four other siblings who do not.
“It is a recessive disease and neither of my parents have the disease. Each of us who has it got one mutant allele (gene) from my mom and one mutant allele from my dad,” he said.
Researchers know about 40 different genes that can cause Charcot-Marie-Tooth. But in each family, only one of these genes is involved.
The sequencing revealed a gene called SH3TC2, the researchers reported in the New England Journal of Medicine. Other groups are already working on a drug that may affect that gene, Lupski said.
The researchers also found that family members who inherited just one faulty copy of the gene had a predisposition to carpal tunnel syndrome, in which a nerve in the wrist can get pinched.
As prices are coming down on the cost of sequencing a human genome, more such research will be possible.
“We estimate that the entire effort would currently cost less than $50,000,” the researchers wrote.
In a second study, Jared Roach of the Institute for Systems Biology in Seattle and colleagues sequenced the entire genomes of a family of four affected by two recessive genetic diseases — Miller syndrome, which can cause facial disfigurement, and primary ciliary dyskinesia, a lung disorder that raises the risk of respiratory infections because the hairlike extension on cells called cilia fail to move properly.
“Our results demonstrate the unique value of complete genome sequencing in families,” they wrote in the journal Science.
They used a sequencer made by another one of the companies exploiting genomic sequencing, Complete Genomics based in Mountain View, California.
February 26, 2010
By David Gutierrez
The pharmaceutical industry is attempting to convince the public that a variety of normal conditions affecting the majority of women should be classified as “female sexual dysfunction” and treated with drugs.
The medical establishment has a long history of treating the female body as sexually dysfunctional, from when Hippocrates first attributed “hysteria” to a wandering uterus. According to JoAnn Wypijewski, former senior editor of The Nation, this perspective fell out of favor with the sexual revolution of the 1970s but has since re-emerged.
“Today the cultural air is thick with sex, but the rhetoric of freedom and rights largely serves a commodified notion of sexual satisfaction,” Wypijewski said. “The politics has dropped out, and without politics we’re all just … potential patients.”
A 2005 article in the medical journal BMJ noted the emergence of drugs intended to treat “female sexual dysfunction.” In spite of skepticism from the medical establishment, the pharmaceutical industry has pressed ahead, insisting that conditions such as an inability to regularly achieve orgasm through intercourse alone, low levels of sexual desire, and sexual dissatisfaction are medical disorders in need of treatment.
All these conditions are normal for women at various points throughout their lives. Yet proponents of the label “female sexual dysfunction” claim that anywhere from 43 percent to 70 percent of women are actually ill; Oprah has called it as an “epidemic.”
The cure, according to the pharmaceutical industry, is testosterone treatment or other drugs. Meanwhile, Wypijewski notes that rates of “vaginal rejuvenation” (tightening) among middle-aged women and “laser labiaplasty” (reshaping of the labia) among younger women continue to rise. A doctor in North Carolina even offers to implant an electrode in women’s spinal columns to help them achieve orgasm during sex.
“Female sexual dysfunction, it turns out, was wholly created by drug companies,” Wypijewski said. “The more obstinate question is … whether a resistant politics can grow up to say … ‘We want out’ of the profit system and … out of a medical model that elevates a doctor over … a more sensual ease with oneself and others.”
February 23, 2010
A Calgary woman regrets getting the H1N1 shot after her doctor told her it likely caused a rare and painful disorder.
Norma Goldring said she felt compelled to get an H1N1 vaccine because she is diabetic and has had a heart attack, two factors that Alberta Health noted as putting people at higher risk for serious complications from swine flu.
But soon after getting the shot last winter, Goldring felt ill.
“My body was aching and I was throwing up. Then I developed a spot on my leg,” she said.
The rash spread quickly and Goldring ended up in hospital on Christmas Day. “By the time I got to emergency, it spread pretty bad and turned to blisters.”
Her kidneys were shutting down. Doctors eventually diagnosed it as vasculitis, an inflammation that destroys blood vessels.
Her doctor, who asked not to be named, concluded it was probably connected to the H1N1 shot. Goldring, according to her doctor, is one of only 31 people since 1974 to have had this type of reaction to a flu shot.
Won’t get shot again, says Goldring
Now, even using a walker to get from her living room to her kitchen causes her excruciating pain. She is on pain killers and steroids.
“It was like I was put through a fire. It was like someone lit me on fire,” she said.
Goldring said she won’t get a flu shot again. Desmond Fordyce, her partner, said he is worried the vaccine wasn’t tested properly before widespread public vaccinations began.
“I think they’re killing you more than giving you something for making you better,” he said.
Dr. Glen Armstrong, head of the microbiology and infectious diseases department at the University of Calgary, said the H1N1 vaccine is safe. “It’s very clear that the benefits of having people get vaccinated, far, far outweigh the risks of the very small number of adverse reactions to the vaccine.”
So far, 25 million doses of the vaccine have been distributed across Canada. Nearly 6,000 H1N1 shots resulted in an adverse reaction, of which more than 200 were considered serious. Health officials are investigating 13 post-shot deaths.
Alberta health officials told CBC News they have talked to Goldring’s doctor and will continue to investigate what happened in her case.
The province has seen 1,276 people hospitalized with H1N1 since April 2009 and 71 deaths have been connected to the virus.