Great article in Trials, on why regulators should stop withholding trial info from doctors and patients

October 18th, 2012 by Ben Goldacre in bad science, big pharma | 5 Comments »

One thing in Bad Pharma has shocked readers more than anything else: the way that vitally important information about trials is withheld from doctors and patients, not just by drug companies, but also by government bodies such NICE and the European Medicines Agency (the body that approves and regulates medicines for the UK).

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Great site BAD SCIENCE http://www.badscience.net/

Chronic Pain Patient, first visit with Pain Management Doctor ~ SIGNING UNFAIR PAIN CONTRACT

Dammed if you do and dammed if you don't!
SIGNING A DRUG CONTRACT ~ FROM PATIENT PERSPECTIVE ~ GIVING UP YOUR RIGHTS

  Chronic pain patients are required to sign contracts with their pain management physician. Many of the stipulations in these contracts remove the patient's rights to privacy of their medical information as well as removing the constitutional rights that require law enforcement to obtain a warrant (meaning need to show probable cause to get such a warrant) in order to get the medical record. These contracts also often contain false information regarding what is drug seeking behavior, physical dependence, and tolerance to pain medication. Also they rely upon presumptive testing that is widely known to be inaccurate in order to deny treatment. Basically these contracts are set up in such a way that every chronic pain patient will eventually violate some part of the contract and lose treatment. Depression is NOT drug seeking behavior, it is a common occurrence with ANY chronic illness, not just chronic pain.

To learn more, including information about the so-called studies that the DEA rely upon to call prescription drug abuse an "epidemic" when the numbrs don't support it. To learn more about chronic pain, contracts, and more:
http://www.dailykos.com/story/2011/04...
http://pain-topics.org/ for updates on studies http://updates.pain-topics.org/

To learn more about Richard Paey, an example of the unfair investigation procedures and prosecution on chronic pain patients see here:
http://www.november.org/thewall/cases...

About Adhesion Related Disorder ~ How can abdominal adhesions cause intestinal obstruction?

Abdominal Adhesions
On this page:

•What are abdominal adhesions?
•What causes abdominal adhesions?
•How can abdominal adhesions cause intestinal obstruction?
•How can abdominal adhesions cause female infertility?
•What are the symptoms of abdominal adhesions?
•What are the symptoms of an intestinal obstruction?
•How are abdominal adhesions and intestinal obstructions diagnosed?
•How are abdominal adhesions and intestinal obstructions treated?
•Can abdominal adhesions be prevented?
•Points to Remember
•Hope through Research
•For More Information

What are abdominal adhesions?
Abdominal adhesions are bands of tissue that form between abdominal tissues and organs. Normally, internal tissues and organs have slippery surfaces, which allow them to shift easily as the body moves. Adhesions cause tissues and organs to stick together.


The intestines are part of the digestive system. Abdominal adhesions can cause an intestinal obstruction.

Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain. Adhesions are also a major cause of intestinal obstruction and female infertility.



What causes abdominal adhesions?
Abdominal surgery is the most frequent cause of abdominal adhesions. Almost everyone who undergoes abdominal surgery develops adhesions; however, the risk is greater after operations on the lower abdomen and pelvis, including bowel and gynecological surgeries. Adhesions can become larger and tighter as time passes, causing problems years after surgery.

Surgery-induced causes of abdominal adhesions include

•tissue incisions, especially those involving internal organs
•the handling of internal organs
•the drying out of internal organs and tissues
•contact of internal tissues with foreign materials, such as gauze, surgical gloves, and stitches
•blood or blood clots that were not rinsed out during surgery
A less common cause of abdominal adhesions is inflammation from sources not related to surgery, including

•appendicitis—in particular, appendix rupture
•radiation treatment for cancer
•gynecological infections
•abdominal infections
Rarely, abdominal adhesions form without apparent cause.



How can abdominal adhesions cause intestinal obstruction?
Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction. An intestinal obstruction partially or completely restricts the movement of food or stool through the intestines. A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.



How can abdominal adhesions cause female infertility?
Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place. Adhesions can kink, twist, or pull out of place the fallopian tubes, which carry eggs from the ovaries—where eggs are stored and released—to the uterus.



What are the symptoms of abdominal adhesions?
Although most abdominal adhesions go unnoticed, the most common symptom is chronic abdominal or pelvic pain. The pain often mimics that of other conditions, including appendicitis, endometriosis, and diverticulitis.



What are the symptoms of an intestinal obstruction?
Symptoms of an intestinal obstruction include

•severe abdominal pain or cramping
•vomiting
•bloating
•loud bowel sounds
•swelling of the abdomen
•inability to pass gas
•constipation
A person with these symptoms should seek medical attention immediately.


How are abdominal adhesions and intestinal obstructions diagnosed?
No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound. Most adhesions are found during exploratory surgery. An intestinal obstruction, however, can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.



How are abdominal adhesions and intestinal obstructions treated?
Treatment for abdominal adhesions is usually not necessary, as most do not cause problems. Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems. More surgery, however, carries the risk of additional adhesions and is avoided when possible.

A complete intestinal obstruction usually requires immediate surgery. A partial obstruction can sometimes be relieved with a liquid or low-residue diet. A low-residue diet is high in dairy products, low in fiber, and more easily broken down into smaller particles by the digestive system.



Can abdominal adhesions be prevented?
Abdominal adhesions are difficult to prevent; however, surgical technique can minimize adhesions.

Laparoscopic surgery avoids opening up the abdomen with a large incision. Instead, the abdomen is inflated with gas while special surgical tools and a video camera are threaded through a few, small abdominal incisions. Inflating the abdomen gives the surgeon room to operate.

If a large abdominal incision is required, a special filmlike material (Seprafilm) can be inserted between organs or between the organs and the abdominal incision at the end of surgery. The filmlike material, which looks similar to wax paper, is absorbed by the body in about a week.

Other steps during surgery to reduce adhesion formation include using starch- and latex-free gloves, handling tissues and organs gently, shortening surgery time, and not allowing tissues to dry out.



Points to Remember
•Abdominal adhesions are bands of tissue that form between abdominal tissues and organs, causing tissues and organs to stick together.
•Although most adhesions cause no symptoms or problems, others cause chronic abdominal or pelvic pain, bowel obstruction, or female infertility.
•Abdominal surgery is the most frequent cause of abdominal adhesions.
•Abdominal adhesions can kink, twist, or pull the intestines out of place, causing an intestinal obstruction.
•A complete intestinal obstruction is life threatening and requires immediate medical attention and often surgery.
•Abdominal adhesions cause female infertility by preventing fertilized eggs from reaching the uterus, where fetal development takes place.
•No tests are available to diagnose adhesions, and adhesions cannot be seen through imaging techniques such as x rays or ultrasound.
•An intestinal obstruction can be seen through abdominal x rays, barium contrast studies—also called a lower GI series—and computerized tomography.
•Surgery is currently the only way to break adhesions that cause pain, intestinal obstruction, or fertility problems.


Hope through Research
The National Institute of Diabetes and Digestive and Kidney Diseases conducts and supports basic and clinical research into many digestive disorders.

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. For information about current studies, visit http://www.clinicaltrials.gov/.

The U.S. Government does not endorse or favor any specific commercial product or company. Trade, proprietary, or company names appearing in this document are used only because they are considered necessary in the context of the information provided. If a product is not mentioned, the omission does not mean or imply that the product is unsatisfactory.



For More Information
American College of Gastroenterology
P.O. Box 342260
Bethesda, MD 20827–2260
Phone: 301–263–9000
Fax: 301–263–9025
Email: info@acg.gi.org
Internet: www.acg.gi.org

International Foundation for Functional Gastrointestinal Disorders
P.O. Box 170864
Milwaukee, WI 53217–8076
Phone: 1–888–964–2001 or 414–964–1799
Fax: 414–964–7176
Email: iffgd@iffgd.org
Internet: www.iffgd.org

You may also find additional information about this topic by visiting MedlinePlus at www.medlineplus.gov.

This publication may contain information about medications. When prepared, this publication included the most current information available. For updates or for questions about any medications, contact the U.S. Food and Drug Administration toll-free at 1–888–INFO–FDA (1–888–463–6332) or visit www.fda.gov. Consult your doctor for more information.
http://digestive.niddk.nih.gov/ddiseases/pubs/intestinaladhesions/

What is ovarian remnant syndrome?

Q:What is ovarian remnant syndrome?

A: Ovarian remnant syndrome (ORS) occurs if any ovarian tissue is left after surgery to remove both ovaries and fallopian tubes, called a bilateral salpingo-oophorectomy. The syndrome occurs if this ovarian tissue causes severe pelvic pain and/or a pelvic mass.

The condition typically occurs because of the surgical technique used to remove the ovaries. Although ORS is considered fairly rare, its incidence appears to have increased in the past 40 years, possibly related to the increased use of laparoscopic surgeries.These surgeries allow the surgeon to operate through two or three tiny incisions instead of a large abdominal incision.

Certain factors increase the risk of incomplete ovarian removal, including a history of endometriosis, pelvic inflammatory disease, previous abdominal or pelvic surgeries and pelvic adhesions. Adhesions are scar tissue that forms after pelvic or abdominal surgery and "sticks" to organs and other tissue. Adhesions make it difficult for the surgeon to completely identify and remove the ovaries because of the fibrous tissue that binds an ovary with the other structures or with the peritoneum, the membrane that covers the inside of the abdomen and pelvis.

If any ovarian tissue is left in your pelvis, it can, in some instances, continue to produce hormones.

The most common symptoms of ovarian remnant syndrome are constant, chronic pelvic pain, difficult or painful intercourse, cyclic pelvic pain, and painful urination and bowel movements.

The condition is diagnosed based on a careful medical history. One sign that there may be residual ovarian tissue is if after your ovaries were removed, you didn't immediately start hormone therapy but didn't experience menopausal symptoms, such as hot flashes. This would suggest that you may still be producing estrogens. An alternative situation is if after surgery, you started hormone therapy and then discontinued it for some reason but didn't experience these symptoms.

Your doctor may also perform an ultrasound, CT scan or MRI to identify any ovarian tissue or pelvic mass and may measure blood levels of follicle-stimulating hormone (FSH) and estradiol. Estradiol is produced by the ovaries and FSH by the pituitary gland in response to hormonal signals from the ovaries. Levels of estradiol should be very low and levels of FSH should be very high after both ovaries have been removed.

If your doctor does find ovarian tissue remnants, you may be treated with medication to suppress any ovarian function, surgery to remove the tissue, or, as a last resort, radiation to destroy the tissue.

http://www.healthywomen.org/content/ask-expert/1761/ovarian-remnant-syndrome?context=womentalk/ask-the-expert&context_title=ask-the-expert

Risk of adhesions and medicolegal issues UK ~ So how much should we tell patients?

Excerpt taken from http://onlinelibrary.wiley.com/doi/10.1576/toag.6.2.1.26993/pdf.
The Obstetrician & Gynaecologist
2004;6(2)
SUPPLEMENT
11
There are a number of quality and risk management
issues surrounding adhesions in surgery.The
surgical speciality has given rise to the highest
number and second highest value of negligence
claims reported to the UK National Health
Service Litigations Authority (NHSLA). The
highest numbers of reported Clinical Negligence
Scheme for Trusts (CNST) claims by speciality
are:
• surgery: 3365
• obstetrics and gynaecology 2237
• medicine 1278
• accident and emergency 803.23
Increasingly, complications resulting from
postoperative intra-abdominal adhesions have
been the subject of medical negligence cases.
These have included failure to diagnose adhesion related
problems, delay in diagnosis, bowel damage
at adhesiolysis, adhesive intestinal obstruction,
infertility or risk of infertility and failure to take
precautions to prevent adhesions. 24 Between
1994–1999, for example, the UK Medical
Defence Union received 77 adhesion-related
claims that resulted in 14 out of court settlements
in 11 years ranging from £7,960 to £124,261
(average £50,765 per case).24 The Medical
Defence Union is one of several insurers for the
private sector; figures are not available for claims
made by the National Health Service.
Anecdotal evidence suggests that the number of
claims and out of court settlements has increased
largely since then.
Duty of care
There is a duty of care to provide careful advice
and sufficient information upon which women
can reach a rational, informed decision on whether
to accept or refuse treatment. In negligence cases
people usually claim that insufficient information
was provided and that, if it had been provided,
consent would not have been granted.
So how is negligence established?
In order for this to be successful it is necessary to:
1) establish a duty of care
2) show a breach of this duty
3) demonstrate that this breach caused the injury.
All three aspects need to be present for negligence
to be established. Recently, in addition to this, the
UK Health Act has also established a duty of
quality.
The Bolam test of negligence (1957) had for
many years set the precedent in determining
negligence. This ruling stated that practitioners
are not negligent if they act in accordance with
practice accepted by a responsible body of
medical opinion. However, recent judgements
suggest that judges are moving away from
accepting what reasonable doctors might do,
towards supporting what reasonable patients
might expect. Recent case law suggests that the
Bolam test is being modified to enable a court to
reject medical opinion if it is not ‘reasonable or
responsible’.25 Physicians are required to understand
their obligations and have a duty to warn a
patient of any material risk inherent in a
proposed procedure, however small.
So how much should we tell patients? It is not
necessary to canvass every risk. However, it is
important to take account of the personality of
the patient, the likelihood of misfortune and what
in the way of warning is needed for the particular
patient’s welfare. Are gynaecologists and surgeons
informing patients about the risk of adhesions?
According to the International Adhesions Society
Patient Survey, the answer is no. Results from this
survey showed that adhesions were mentioned as
part of the consent process in only 10.4% of
cases.26 In 14.4% of cases, adhesions were discussed
but not as part of the consent process. For patients
undergoing adhesiolysis procedures, 54% were
given some information before surgery and 46%
were given specific information about antiadhesion
agents. In nonadhesiolysis procedures
only 10% of patients were advised about adhesions
and only 6% were given information on antiadhesion
agents.
Negligence cases relating to adhesions are
becoming more common. It is important to be
aware that the law governing negligence has
changed. Doctors are obliged to understand their
obligations and this will mean warning of the
risk of adhesions prior to abdominal or pelvic
surgery.

Adhesions, Adhesions-Related Disorder or CAPPS – a way to think about the problem from the patient’s perspective.

Dallas TX. June 11 2010. The International Adhesions Society (IAS) is proud to post on its adhesions.org web site the results of groundbreaking and innovative research which will forever change the way the problem of adhesions is viewed.

The paper was published after Dr. Wiseman was invited to submit a manuscript for inclusion in a special volume of “Seminars in Reproductive Medicine” on the subject of adhesions. The paper is entitled: “Disorders of Adhesions or Adhesion-Related Disorder: Monolithic Entities or Part of Something Bigger—CAPPS? “ (click here for .pdf)

Since forming the International Adhesions Society (IAS) in 1996, it became increasingly obvious that the problems of patients suffering from adhesions were not just about adhesions. Accordingly, we were the first to coin the term “Adhesion Related Disorder” (ARD) to include the entire complex of pain, infertility, obstruction, nutrition, psychological and social issues that ARD sufferers and their families experience.

Based on formal patient surveys as well as thousands of emails and phone calls from patients, it became apparent to us that even the term ARD may be inadequate to address the problem. In reality, the ARD patient is part of a much larger group of patients who, in varying degrees, combinations and sequences experience a range of symptoms and conditions including endometriosis, interstitial cystitis (IC), irritable bowel syndrome (IBS), bowel obstruction and chronic abdominal and/or pelvic pain.

Although ‘‘adhesions’’ may start out as a single, stand-alone entity, an adhesions patient may develop a number of related conditions (ARD) which renders those patients practically indistinguishable from patients with multiple symptoms originating from other abdominal or pelvic conditions. (continued)

Click here for a pdf copy of the entire press release.

Click here for a .pdf copy of the CAPPS article

As always, our sincere thanks to the International Adhesion Society.
Visit the IAS at http://www.adhesions.org/

Is HIPAA Hiding the Wrong Kind of Secrets?

August 16th, 2010 Anyone who has been to a doctor in the last dozen years has seen and signed the HIPAA (Health Insurance Portability & Accountability Act) form given out by their doctor or hospital. The HIPAA Privacy Rule was specifically designed to protect the privacy and integrity of personal health information collected by medical professionals about their patients.

Essentially this means that it is illegal to release the specifics of a patient case you may have either attended or witnessed. Thinking in terms of a laboring woman, what happens in her hospital room stays in her hospital room.

Doulas are not bound to HIPAA, but we do carry a professional code of ethics which makes it unprofessional to openly discuss our clients’ cases. Some of us may gather in small circles to privately work out our thoughts on situations we may have been in, and try to grow our knowledge base by sharing experiences. However, it is considered quite unprofessional to openly discuss any identifying details of a specific mother’s birth experience.

Of course, privacy is essential to trust. A woman cannot trust a provider who would willingly pass the details of her case around the internet for all the world to see. For the most part, it is nobody’s business what happens during her labor.

Well, unless it IS.

Speaking in generalities, because I will not discuss specific cases, I can tell you that some things I’ve witnessed as a doula in a labor room have been nothing short of a crime. Women have the right to informed consent and refusal, and I have seen cases where that right is violated over and over again throughout a labor. According to the American Medical Association,

“Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention…

…This communications process, or a variation thereof, is both an ethical obligation and a legal requirement spelled out in statutes and case law in all 50 states.”

So what happens when a woman flatly refuses to give consent, and a physician performs a procedure without her authorization and against her will? Katherine Prown, Ph.D. tells us,

“The legal doctrine of informed consent/refusal developed from the laws on battery. In a medical setting battery is defined as touching or treatment that occurs without obtaining proper informed consent; medical treatments that are substantially different from the ones a patient consented to; treatment that exceeds the scope of consent; or treatment provided by a physician other than the physician who obtained the patient’s consent. As case law on informed consent/refusal evolved, however, the courts increasingly defined lack of proper consent as a matter of negligence. Negligence requires that the lack of proper consent or failure to meet the standard of care resulted in emotional or physical harm worthy of monetary compensation. In certain circumstances in which monetary compensation is not an issue, though, the laws on battery may still apply.”

Given this, I have borne witness to cases where a woman’s rights are so flagrantly violated that it seems like an obscene injustice not to tell the world about what happened to her. But once the labor is over, the dozen or so people in that room simply move on to another labor, and because of privacy laws like HIPAA, nothing that happened is ever shared with the public.

You might be asking “Is it really that bad? Can it really, seriously be that bad?” You tell me. (**Trigger Warning**)

•I have seen a mother flat out refuse a procedure and/or treatment and the doctor say, verbatim, “You can say no, but we’re doing it anyway.” And they did. And nobody in the room could stop them.
•I’ve seen the mother’s parents get into yelling matches with the nurse or doctor because the medical staff constantly coerced or threatened the laboring woman to the point of emotional distress.
•I’ve seen a doctor stand over a woman and force her to “pre-authorize” a major intervention that was neither wanted, needed, or ever actually used during the labor, and refuse to leave the room until her signature was on the paper – giving her no time to contemplate the decision or discuss it with her family.
•I’ve seen a woman scream “No, stop!” while trying to kick a doctor’s hands out of her, as she tries climbing up the back of the bed to escape, while the doctor ignored her pleas and reaches farther into her vagina – blood curdling screams fill the room.
•I’ve had women cry and beg me to help them – to keep the doctor or nurse from doing whatever it is they’re doing to them – and I can’t help at all. Being a bodyguard is outside my professional scope of practice.
•I’ve seen a woman say she does not want an episiotomy, and the doctor say “Sorry” (snip, snip, snip) “I had to make some room.”
On one hand, I’m glad I was there to help those women in whatever way I could. On the other hand, it’s terribly stressful having witnessed crimes against women and know that professional secrecy will prevent everyone in that room from discussing what happened to her.

Of course the mother could take this information to the authorities, but that rarely ever happens. On one hand, as long as the mother came out with a healthy baby, nobody cares how she was treated in the process. She would need to have a damaged baby to have any sort of a legal case that an attorney would see worth his/her time. It’s also quite easy for a laboring woman not to remember or understand the details of what was being done to her. She’s in laborland – not taking minutes in a meeting. Women also have a hard time coming to terms with being violated.

This is the same reason so many women don’t report rape. After the incident is over, they just want it to be over. They don’t want to think about it, or drag it through a court system. They may think that it’s partially their fault, or that going public may put their story under embarassing and unfair scrutiny. When I took my VBAC story to the Chicago Tribune, my obstetrician accused women like me of having a “control issue.” No apology. No admission that his behavior was unethical and potentially illegal. He simply blamed me for not submitting to his violation. There are a million reasons women do not report violations, coupled with a million violators who continue to practice the way they do without anyone holding them accountable.

What can be done? At what point can we, who witness these crimes, open this can of worms and start talking about what is happening to individual women every single day in this system of ours? I know that it’s not my place to file complaint about the way a woman was treated, but if there’s no transparency, where does that leave us? I can tell you that it leaves me angry in my bones and feeling sick to my stomach.

In the mean time, I have to decide whether or not I can handle seeing any more of these hospital births, or if I should send women in to the lion’s den without someone like me there to help them in whatever small way I can. It’s a tough decision, and one that I may grapple with for a long time to come.

_______________________________________________________

If you are a mother who was violated, did you report any of it? Was there a resolution? If you are a birth professional who has witnessed these births, how do you recover emotionally knowing there’s nothing you can do?

http://thefeministbreeder.com/is-hipaa-hiding-the-wrong-kind-of-secrets/