DECEMBER NEWS
Greetings! We have a lot of news this month, and we've only covered some of the high points of December's health-related stories. A class of psychiatric drugs known as atypical anti-psychotics has been making headlines and raising hackles all over the United States and Canada. Bad publicity about the EPFX machine has continued, with a couple of new developments and a frustrating lack of reliable information. The FDA has made negative headlines for a number of reasons, as has New York University's Child Study Center. Finally, there's a bunch of internal BANA news!
Let's cover the BANA news first.The administration of our insurance policies is moving back to Stratus in January. Please be patient with us during the transition time. We'll do our best to make sure nobody is forgotten. If you have any questions or need to check on the progress of your membership renewal, please email info.bana@gmail.com. It may take us a day or two to find out the answer for you, but we'll get back to you as quickly as we can. Nothing about your existing insurance policies will be affected by the change. If any other changes occur as a result of this move, we'll let you know.
New BANA Benefit
We've been getting unhappy phone calls about a side-effect of the current EPFX controversy. Biofeedback practitioners are reporting that clients have refused to pay their bills, claiming the treatments they received were "bogus" or "fraud". Wait; doesn't your informed consent form refer billing disputes to arbitration? Unfortunately, the cost of arbitration can be up to $1000 per episode, and requires up-front payments in the range of $300. The cost of recovering the money owed is often higher than the original debt. What's a biofeedback practitioner to do?
The answer is simple: join BANA! Our insurance negotiator, never one to let the grass grow under his feet, has made arrangements for a new benefit for BANA members: free arbitration! The Natural Therapies Arbitration Council has agreed to provide arbitration services to BANA members. In order to qualify for this benefit, you must be certified as a Biofeedback Technician or Specialist, and you must use an informed consent form. Existing BANA members qualify for this benefit as of 1/1/08. We should have all the details on our website shortly after the first of the year.
What if you're not a BANA member? Non-members may purchase the arbitration benefit for $45/year. To qualify you must be certified by NTCB or BCIA and use an approved Informed Consent Form. The regular cost of this service is $95.00 a year.
Questions? Email info.bana@gmail.com.
Newsletter Change
Beginning in January 2008, the newsletter will undergo a makeover thanks to one of our talented office staff! The types of material covered will remain about the same, but expect to see a more professional appearance and layout. We're also going to try to put the newsletter out earlier in the month, but that will depend partly on developing stories. It can take time to ferret out accurate, verifiable information on some of these issues, and we want to give you the best information we can possibly find. Urgent developments may be sent out as special newsletters between the regular monthly mailings. One way or another, we'll do our best to keep you informed.
New FDA Guidelines Legitimize Promotion of Unapproved Uses of Drugs
In other FDA news, just as the agency has announced a crackdown on unapproved claims about the efficacy of the EPFX, it is also seeking to legitimize the drug industry's questionable practice of promoting unapproved, off-label uses of medical devices and drugs. (Differential treatment of alternative healthcare and Big Pharma? Perish the thought!) This promotion is commonly done by means of ghost-written articles for medical journals --- articles which have a history of being filled with inaccuracies and false claims. Proposed new FDA guidelines would give the green light for drug companies to provide copies of these misleading articles to doctors.
Representative Henry Waxman (D – CA) has formally requested FDA Commissioner Andrew von Eschenbach to put the new guidelines on hold, and has asked the FDA to give him information about the development of the guidelines.
To read more go to: http://www.oversight.house.gov/story.asp?ID=1644
FDA Gets Failing Grade from Its Own Science Board
Meanwhile, the FDA has come under harsh fire from a report issued by the FDA's own Science Board. This reports state that the FDA is failing in every aspect of its official mission, and is no longer capable of carrying out any of its assigned tasks. The report agrees with another scathing report issued in 2006 by the Institute of Medicine. Unfortunately the FDA seems to have ignored the IOM report, and shows no signs of paying attention to the Science Board report either. It's likely that in spite of the conclusions reached by these two bodies, the FDA will continue to sideline safety issues. When they don't think it's broken, why should they bother to fix it?
To read more, go to: http://www.reuters.com/article/domesticNews/idUSN0344400420071203
Atypical Anti-psychotic Drugs Under Fire for Risks
Atypical anti-psychotics, so-called to distinguish them from the older generation of "typical anti-psychotics" such as Haldol, were zoomed into the hands of doctors during the 1990s. Often, atypical received the green light of FDA approval after safety studies lasting as little as six weeks. Touted as “better and safer” than typical anti-psychotics, drugs such as Risperdal and Zyprexa soared in popularity among doctors. Millions of prescriptions were written, and drug companies profited mightily.
As prescription rates for these drugs soared, however, so did evidence of lethal side effects: diabetes, hypoglycemia, metabolic syndrome, significant weight gain, cardiovascular disease, and other serious problems. Unfortunately, atypical are commonly administered "off-label" (contrary to official label recommendations) for a wide range of unapproved uses. The FDA is not only ignoring the off-label situation, they have approved two atypicals (Risperdal and Abilify) for use in teens and are about to approve Zyprexa as well. Risperdal has been approved for use on autistic children, in spite of evidence that it causes an irreversible movement disorder.
Children are not the only sufferers. Atypicals are also being increasingly administered to senior citizens in nursing homes, in spite of statistics showing an increase of up to 60% in death rates among elderly patients taking these drugs. Senator Chuck Grassley (R-IA) has launched an investigation into Medicaid costs on these drugs, and whether the current habit of prescription for incapacitated seniors constitutes abuse.
That's not all. Problems with atypical anti-psychotics are so severe that states have begun to sue their manufacturers. The state of Arkansas recently filed suit against Johnson & Johnson, the maker of Risperdal, alleging that they knew the drug was "defective" and that they illegally marketed it for off-label uses. Nine other states have sued Lilly seeking reimbursement of Medicaid funds used to pay for Zyprexa. Thirty state attorney generals are looking into whether their states too should sue over these issues. Expect to see the controversy increase in coming months as these lawsuits and investigations begin to bear fruit.
To read more, go to: http://www.sptimes.com/2007/07/29/Worldandnation/The__atypical__dilemm.shtml
Canadian Broadcasting Company Offers Caution over Rise in Drug Prescriptions
America isn't the only nation showing an alarming rise in the prescription of atypical anti-psychotics for dangerous off-label uses. A CBC investigation of Canadian prescription habits for these drugs showed sharp increases, up to 40%, over the last 2 years. Health Canada increased their program of warning doctors not to hand out atypicals too readily, but the trend has continued and even expanded despite their efforts. Many doctors use these powerful, dangerous drugs to treat conditions such as anxiety and dementia. There's no word as of yet what action the Canadian government will take over that practice.
To read more, go to: http://www.cbc.ca/health/story/2007/12/17/dangerous-drugs.html
A New Light on Obesity Statistics
Statistics reveal that figures on the increasing trend toward obesity in Americans, particularly American children, may be influenced by drug side effects. Zyprexa, the atypical antipsychotic mentioned in the above article, was fast-tracked to approval despite the fact that 29% of the patients enrolled in the six-week safety study gained significant amounts of weight in a short time --- a warning sign of vulnerability to diabetes. It turns out that the drug elevates blood sugar and cholesterol levels, an effect common to the atypical anti-psychotics. The blood sugar boost is serious enough that in 2003 the FDA required warning labels be put on that entire class of drugs. This year Lilly was forced to put a warning on the Zyprexa label stating that it increases blood sugar to a greater degree than its competitors do.
22 million people have taken or are taking Zyprexa, among them many children and teens. If the safety studies are any guideline, approximately 6.4 million people (29% of 22 million) may have experienced serious weight gain because of their prescription for this drug. That figure is bad enough, but millions of people take other atypical anti-psychotics, all of which have the same side effects. The actual number may be much higher than 6.4 million.
There's no sign of a cure in sight, either. Atypical anti-psychotics are the poster drugs for the current effort to screen all American kids for mental health issues. If the present habit of prescribing these drugs for children rises, you can guarantee that so will childhood obesity rates. Studies involving children on Zyprexa demonstrated that kids enrolled in the studies lost their capacity to feel full, experienced constant hunger, and showed weight gains of 5 to 15 lbs per week. Some children gained as much as 50 lbs. One study of several atypicals stopped the Zyprexa portion of the study because kids gained so much weight so quickly. Is the widespread use of atypical anti-psychotics really a recipe for better health for Americans?
To read more, go to: http://www.sptimes.com/2007/07/29/Worldandnation/The__atypical__dilemm.shtml
In other FDA-related controversies, the agency is taking the side of drug and device manufacturers in a case presently before the Supreme Court. At issue is whether or not a consumer who has been injured by an approved drug or medical device can sue under state liability laws for damages. Lower court rulings have stated that if a device or drug is pre-approved for use by the FDA, then the manufacturer is immune from liability at the state level. This is the position the FDA endorses. The Public Citizen Litigation Group, speaking in support of the patient's right to seek redress for damages, pointed out that the pre-approval process is not tough enough to ensure product safety. As an immense body of evidence indicates, they understated their case!
Should the Supreme Court agree with lower courts and limit state jurisdiction over medical product liability, it will open the door to an even greater range of problems caused by defective and dangerous products sheltering behind the FDA's protective skirts. If state courts can't hold a medical manufacturer financially liable for damage caused by their product, and the FDA allows flawed products to be rushed through the approval process, then what incentive do the manufacturers have for abiding by any sort of safety standards at all?
To read more, go to: http://www.nytimes.com/2007/12/05/washington/05bizcourt.html?ref=health
"Ransom Note" Ad Campaign Sparks Furor
The FDA isn't the only target of controversy over its actions right now. New York University's Child Study Center is in the center of a hurricane created by a new advertising campaign aimed at increasing the number of children who receive psychiatric treatment. The advertisements were written and designed to look like ransom notes written to a child's parents by various "kidnappers" such as ADHD and obsessive-compulsive disorder. The language of the ads is blunt and bigoted, stating that children's lives will be destroyed if parents don't act to get immediate psychiatric treatment, and implying that children with these disorders are subnormal and offensive to those around them. Furthermore, the advertisements targeted two conditions, autism and Asperger's Syndrome, which are neurological syndromes rather than psychiatric disorders.
Fourteen prominent disability groups banded together to launch a campaign of their own, demanding that these misleading and offensive ads be taken down. The theme of their effort? WE ARE NOT FOR RANSOM. After much controversy, the Center agreed to discontinue the ad campaign, but promised to unveil a new campaign in the next three months. One can only speculate as to how far the new campaign will go.
To read more, go to: http://www.nydailynews.com/lifestyle/health/2007/12/14/20071214_psych_groups_fury_over_ransom_ads-1.html
(You will need to copy and paste the above link into your browser because it's too long to fit on a single line of newsletter text.)
http://www.nytimes.com/2007/12/20/business/media/20child.html
In closing, 2008 promises to be an eventful year. I would like on behalf of everyone here at BANA to wish all of you a fruitful, happy, and healthy New Year. Our members are the reason we exist. We appreciate each and every one of you!
Yours for Health,
Sara Greer
Executive Director, BANA
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