Relentless and Tragic Marketing: Psychiatric Drugs from Before the Cradle to the Grave

by John Breeding, PhD and Amy Philo

Working with others, we strive to alleviate distress and to support and enhance the personal growth, transformation, individuation, self-determination, and clear and expanded awareness of individuals. Necessity dictates that we also spend a lot of time challenging aspects of the mental health profession that do the opposite—creating more distress, suppressing growth and transformation, violating self-determination, and dulling and blinding awareness. We call it psychiatric oppression, the systematic, institutionalized mistreatment of those judged as “mentally ill.” This essay focuses especially on the ever expanding encroachment of psychiatric oppression to more and more of the population, and to individuals who are less and less in need of actual help. This encroachment takes the form of mass marketing for psychiatry and the pharmaceutical industry. One key aspect of oppression theory is the claim to virtue. For psychiatric oppression that claim is the notion that mentally ill people need their treatment; its growing extension is the concept of prevention, that potentially mentally ill people need treatment as well!

The Regressive Progression: Treatment to Prevention

“An ounce of prevention is a pound of cure.” Like all great aphorisms, this one, often associated with Ben Franklin, holds wisdom and is partly true, based on assumption. In this case, one must assume the role of victim of unnecessary malady that necessitates a cure…and that there is a felt connection or empathic relatedness to the one who suffers malady. Where these assumptions are not met, the aphorism is false. To wit, for the giant corporation of Halliburton and its government and military operations group, or for the mercenary army of Blackwater, going to war is worth a great deal more than diplomacy.

Continue reading “Relentless and Tragic Marketing: Psychiatric Drugs from Before the Cradle to the Grave”

Brown Victory Brings Hope of Stalling MOTHERS Act in Health Care Bill

“I have no interest in sugarcoating what happened in Massachusetts,” said Sen. Robert Menendez, the head of the Senate Democrats’ campaign committee. “There is a lot of anxiety in the country right now. Americans are understandably impatient.”

Menendez says Americans have high anxiety and are impatient? Oh geez Louise… Speaking of sugarcoating… I recall using that word in reference to Menendez and the MOTHERS Act pushers a few more than 10 times.

In epic upset, GOP’s Brown wins Mass. Senate race

By GLEN JOHNSON and LIZ SIDOTI, Associated Press Writers Glen Johnson And Liz Sidoti, Associated Press Writers 17 mins ago

BOSTON – In an epic upset in liberal Massachusetts, Republican Scott Brown rode a wave of voter anger to win the U.S. Senate seat held by the late Edward M. Kennedy for nearly half a century, leaving President Barack Obama’s health care overhaul in doubt and marring the end of his first year in office.

The loss by the once-favored Democrat Martha Coakley in the Democratic stronghold was a stunning embarrassment for the White House after Obama rushed to Boston on Sunday to try to save the foundering candidate. Her defeat on Tuesday signaled big political problems for the president’s party this fall when House, Senate and gubernatorial candidates are on the ballot nationwide.

“I have no interest in sugarcoating what happened in Massachusetts,” said Sen. Robert Menendez, the head of the Senate Democrats’ campaign committee. “There is a lot of anxiety in the country right now. Americans are understandably impatient.”

Brown will become the 41st Republican in the 100-member Senate, which could allow the GOP to block the president’s health care legislation and the rest of his agenda. Democrats needed Coakley to win for a 60th vote to thwart Republican filibusters.

The Republican will finish Kennedy’s unexpired term, facing re-election in 2012.

Brown led by 52 per cent to 47 percent with all but 3 percent of precincts counted.

One day shy of the first anniversary of Obama’s swearing-in, the election played out amid a backdrop of animosity and resentment from voters over persistently high unemployment, Wall Street bailouts, exploding federal budget deficits and partisan wrangling over health care.

For weeks considered a long shot, Brown seized on voter discontent to overtake Coakley in the campaign’s final stretch. His candidacy energized Republicans, including backers of the “tea party” protest movement, while attracting disappointed Democrats and independents uneasy with where they felt the nation was heading.

A cornerstone of Brown’s campaign was his promise to vote against the health care plan.

Though the president wasn’t on the ballot, he was on many voters’ minds.

“I voted for Obama because I wanted change. … I thought he’d bring it to us, but I just don’t like the direction that he’s heading,” said John Triolo, 38, a registered independent who voted in Fitchburg.

He said his frustrations, including what he considered the too-quick pace of health care legislation, led him to vote for Brown.

Coakley called Brown conceding the race, and Obama talked to both Brown and Coakley, congratulating them on the race.

The Democrat said the president told her: “We can’t win them all.”

Massachusetts Secretary of State William Galvin said he would notify the U.S. Senate on Wednesday that Brown had been elected. Originally, he had said he might take over two weeks to certify the results of the special election, giving Democrats a window in which to try to rush through final passage of Obama’s health care plan.

Senate Majority Leader Harry Reid, D-Nev., promised to seat Brown “as soon as the proper paperwork has been received.”

Brown will be the first Republican senator from Massachusetts in 30 years.

Even before the first results were announced, administration officials were privately accusing Coakley of a poorly run campaign and playing down the notion that Obama or a toxic political landscape had much to do with the outcome.

Coakley’s supporters, in turn, blamed that very environment, saying her lead dropped significantly after the Senate passed health care reform shortly before Christmas and after the Christmas Day attempted airliner bombing that Obama himself said showed a failure of his administration.

Days before the polls closed, Democrats were fingerpointing and laying blame.

Rep. Chris Van Hollen of Maryland, head of the House Democrats’ campaign effort, said Coakley’s loss won’t deter his colleagues from continuing to blame the previous administration.

“President George W. Bush and House Republicans drove our economy into a ditch and tried to run away from the accident,” he said. “President Obama and congressional Democrats have been focused repairing the damage to our economy.”

At Boston’s Park Plaza Hotel, giddy Republicans cheered, chanted “USA” and waved the “tea party” version of the American flag.

Even before Brown won, the grass-roots network fueled by antiestablishment frustrations, sought credit for the victory, much like the liberal did in the 2006 midterm elections when Democrats rose to power.

GOP chairman Michael Steele said Brown’s “message of lower taxes, smaller government and fiscal responsibility clearly resonated with independent-minded voters in Massachusetts who were looking for a solution to decades of failed Democrat leadership.”

Wall Street watched the election closely. The Dow Jones industrial average rose 116 points, and analysts attributed the increase to hopes the election would make it harder for Obama to make his changes to health care. That eased investor concerns that profits at companies such as insurers and drug makers would suffer.

Across Massachusetts, voters who had been bombarded with phone calls and dizzied with nonstop campaign commercials for Coakley and Brown gave a fitting turnout despite intermittent snow and rain statewide.

Galvin, who discounted sporadic reports of voter irregularities throughout the day, predicted turnout ranging from 1.6 million to 2.2 million, 40 percent to 55 percent of registered voters. The Dec. 8 primary had a scant turnout of about 20 percent.

Voters considered national issues including health care and the federal budget deficits.

Fears about spending drove Karla Bunch, 49, to vote for Brown. “It’s time for the country, for the taxpayers, to take back their money,” she said. And Elizabeth Reddin, 65, voted for Brown because she said she was turned off by the Democrat’s negative advertisements, saying: “The Coakley stuff was disgusting.”


Liz Sidoti reported from Washington. Associated Press writers Beth Fouhy, Bob Salsberg, Steve LeBlanc, Karen Testa, Kevin Vineys and Stephanie Reitz also contributed to this report.

Leonard Roy Frank Letter to FDA: Case Against ECT

From: Leonard Roy Frank

January 7, 2010

To: Food and Drug Administration

Dockets Management Branch (HFA-305)

5630 Fishers Lane

Room 1061

Rockville, MD  20852

Docket Number FDA-2009-N-0392

To whom it may concern:

As a survivor and opponent of electroshock (ECT, electroconvulsive “treatment”) who, over the years, has communicated with hundreds of other survivors of the procedure and has studied the subject and written extensively about it, I am responding to the Food and Drug Administration’s call for information and comments regarding the current classification of the ECT devices. I urge the FDA not to reclassify these devices from Class III (high risk) to Class II (low risk) because the procedure continues to be, as it has been since its introduction in 1938, an extremely harmful method used on persons diagnosed as “mentally ill.”

Here, in summary form, is my case against ECT:

1. Electroshock is a brutal, dehumanizing, memory-destroying, intelligence-lowering, brain-damaging, brainwashing, and life-threatening technique. ECT robs people of their memories, their personality and their humanity. It reduces their capacity to lead full, meaningful lives; it crushes their spirits. Put simply, electroshock is a method for gutting the brain in order to control and punish people who fall or step out of line, and intimidate others who are on the verge of doing so.

2. Brain damage is the most ruinous effect of ECT and lies at the root of most of ECT’s other harmful effects. It is also the 800-pound gorilla in the living room whose existence electroshock psychiatrists refuse to acknowledge, at least publicly. Nowhere is this more clearly illustrated than in the American Psychiatric Association’s Practice of Electroconvulsive Therapy, which states that “in light of the accumulated body of data dealing with structural effects of ECT, ‘brain damage’ should not be included [in the ECT consent form] as a potential risk of treatment” (2001, p. 102). The exclusion of brain damage as a risk of ECT makes a sham of the entire ECT informed-consent process and turns what is ostensibly a medical procedure into an act of criminal assault. The following statements and reports, all by psychiatrists or neurologists, refute the APA’s position on the risk of brain damage from ECT.

A. “The importance of the [foregoing autopsied] case lies in that it offers a clear demonstration of the fact that electrical convulsion treatment is followed at times by structural damage of the brain” (Alpers and Hughes, 1942).

B. “This brings us for a moment to a discussion of the brain damage produced by electroshock…. Is a certain amount of brain damage not necessary in this type of treatment? Frontal lobotomy indicates that improvement takes place by a definite damage of certain parts of the brain” (Hoch, 1948). Paul H. Hoch, a Hungarian-born U.S. psychiatrist, had been commissioner of the New York State Department of Mental Hygiene.

C. In a report “based on the study of 214 electroshock fatalities reported in the literature and 40 fatalities heretofore unpublished, made available through the kindness of the members of the Eastern Psychiatric Research Association,” David Impastato found that 66 ECT patients had died from “cerebral” causes among the 235 patients for whom the cause of death had been stated (Impastato, 1957). Impastato, a Sicilian-born U.S. psychiatrist, was a leading figure in the early history of ECT in the United States.

D. An extensive American Psychiatric Association membership survey found that 41 percent of the respondents agreed with the statement, “It is likely that ECT produces slight or subtle brain damage”; 26 percent disagreed with the statement (American Psychiatric Association, 1978).

E. “Electroshock ‘works’ by damaging the brain…. [T]he changes one sees when electroshock is administered are completely consistent with any acute brain injury, such as a blow to the head with a hammer” (Coleman, 1978).

F. “The principal complications of EST are death, brain damage, memory impairment, and spontaneous seizures. These complications are similar to those seen after head trauma, with which EST has been compared” (Fink, 1978). Eleven years later, Fink was quoted in a magazine article as saying, “I can’t prove there’s no brain damage [from ECT]. I can’t prove there are no other sentient beings in the universe, either. But scientists have been trying for thirty years to find both, and so far they haven’t come up with a thing” (Rymer, 1989). Max Fink, an Austrian-born U.S. psychiatrist, is the world’s leading proponent of ECT.

G. “After a few sessions of ECT the symptoms are those of moderate cerebral contusion, and further enthusiastic use of ECT may result in the patient functioning at a subhuman level. Electroconvulsive therapy in effect may be defined as a controlled type of brain damage produced by electrical means…. In all cases the ECT “response” is due to the concussion‑type, or more serious, effect of ECT. The patient “forgets” his symptoms because the brain damage destroys memory traces in the brain, and the patient has to pay for this by a reduction in mental capacity of varying degree” (Sament, 1983).

H. “A vast medical literature provides strong evidence that electroconvulsive therapy causes permanent brain damage, including loss of memory and catastrophic deterioration of personality” (Polk, 1993).

I. “There is an extensive animal research literature confirming brain damage from ECT. The damage is demonstrated in many large animal studies, human autopsy studies, brain wave studies, and an occasional CT scan study. Animal and human autopsy studies show that ECT routinely causes widespread pinpoint hemorrhages and scattered cell death. While the damage can be found throughout the brain, it is often worst in the region beneath the electrodes. Since at least one electrode always lies over the frontal lobe, it is no exaggeration to call ECT an electrical lobotomy” (Breggin, 1998).

3. The most immediate, obvious, and distressing effect of electroshock is amnesia. In her book Doctors of Deception: What They Don’t Want You to Know About Shock Treatment, electroshock survivor Linda Andre described what that is like: “The memory ‘loss’ that happens with shock treatment is really memory erasure. A period of time is wiped out as if it never happened. Unlike memory loss associated with other conditions, such as Alzheimer’s, which come on gradually and allow patients and families to anticipate and prepare for the loss to some extent, the amnesia associated with… ECT is sudden, violent, and unexpected. Your life is essentially unlived…. You didn’t just lose your suitcase; you can’t say where you got it, what it looks like, what you packed in it, what trips you’ve taken it on. You don’t know that you ever had it” (Andre, 2009).

4. Electroshock’s harmful effects can be long-lasting. Electroshock psychologist Harold A. Sackeim and colleagues concluded their recent study with this statement:  “[T]his study provides the first evidence in a large, prospective sample that adverse cognitive effects can persist for an extended period, and that they characterize routine treatment with ECT in community settings” (Sackeim, 2007).

5. Electroshock causes a significant number of deaths. A 1995 report from the Texas Mental Health Department (Smith, 1995) revealed that there were eight deaths among approximately 1,600 patients (1 in 200 cases) who had undergone ECT in Texas over a then recent 15-month period, a rate 50 times higher than the death rate (“about 1 in 10,000 patients”) given in the consent-form sample in the American Psychiatric Association’s Practice of Electroconvulsive Therapy (2001, p. 320). Reports in the professional literature give further evidence that the ECT death rate is much higher than

the rate claimed by ECT proponents (Frank, 2007).

6. There are no scientifically sound studies showing that ECT is an effective method of suicide prevention. The authors of a large study published in the Annals of Clinical Psychiatry (Black, 1989) reported there was no significant difference in the suicide rate for depressed patients treated with ECT, anti-depressants, and neither of these treatments.

7. Unlike its harmful effects, electroshock’s supposedly “therapeutic” effects are brief at best. No study shows that these effects persist for more than at most a few months following the last treatment. One study indicates the relapse rate for ECT patients is up to 50 percent within six months following treatment, “even though antidepressant drugs are continued” (Fink, 1999). Another study of patients diagnosed with “unipolar major depression” concluded “that without active treatment virtually all remitted patients [i.e., patients whose symptoms diminished following ECT] relapse within 6 months of stopping ECT” (Sackeim, 2001). From this, it is clear that an ECT patient with a diagnosis of depression or manic-depression runs the serious risk of becoming a permanent outpatient which usually entails ongoing drug treatment, “maintenance” ECT, and/or occasional inpatient stays.

8. Contrary to claims by ECT defenders, newer technique modifications have made electroshock more harmful than ever. For example, the drugs accompanying ECT to reduce certain risks, including bone fractures, raise seizure threshold so that more electrical current is required to induce the convulsion (Saltzman, 1955): the more current applied, the greater is risk of brain damage and amnesia. Moreover, whereas formerly ECT specialists tried to induce seizures with minimal current, suprathreshold amounts of electricity are commonly administered today in the belief that they are more effective.

9. Not only does the federal government stand by passively as psychiatrists continue to use electroshock, it also actively supports ECT through the licensing and funding of hospitals where the procedure is used, by covering ECT costs in its insurance programs (including Medicare), and by financing ECT research, including some of the most damaging ECT techniques ever devised. One study provides an example of such research. This ECT experiment was conducted at Wake Forest University School of Medicine/North Carolina Baptist Hospital, Winston-Salem, between 1995 and 1998. It involved the application of electric current at up to 12 times the individual’s convulsive threshold on 36 depressed patients. This reckless disregard for the safety of ECT subjects was supported by grants from the National Institute of Mental Health (McCall, 2000).

10. The use of ECT is increasing. More than 100,000 Americans are being electroshocked each year; half are 60 and older, and two-thirds are women. Seventy percent of all ECT is insurance-covered. ECT specialists on average have incomes twice that of other psychiatrists. The cost for inpatient ECT ranges from $50,000 to $75,000 per series (usually 8 to 12 individual sessions). Electroshock is a multibillion-dollar-a-year industry.

11. Electroshock is especially dangerous and life-threatening for elderly patients. One Rhode Island study conducted between 1974 and 1983 divided 65 hospitalized depressed patients, 80 years and older, into two groups. Thirty-seven patients in one group were treated with ECT and the 28 in the other group were treated with antidepressant drugs. The death rate after one year for the ECT group was 7.5 times higher than that of the non-ECT group: 10 deaths among the 37 ECT patients (27%) compared with 1 death among the 28 drug-treated patients (3.6%). The authors, 2 psychiatrists, reported that “two patients had only 2 ECTs: one withdrew consent, and the other developed CHF [congestive heart failure] and died before ECT could be continued.” They also reported that there was “lasting recovery” for 22% in the ECT group and 71% in the non-ECT group. The authors attributed the poor outcomes of the ECT patients to “their advanced age and physical illness” (Kroessler and Fogel, 1993). In his extensive study of ECT deaths (referred to in paragraph 2C above), Impastato estimated that the ECT death rate for patients over 60 is one in 200, or 5 times greater than the death rate of 1 in 1,000 for ECT patients of all ages (1957, p. 31).

12. As a destroyer of memories and thoughts, electroshock is a direct, violent assault on these hallmarks of American liberty: freedom of conscience, freedom of belief, freedom of thought, freedom of religion, freedom of speech, freedom from assault, and freedom from cruel and unusual punishment.

Tens of thousands of people every year in the United States are deceived or coerced into undergoing electroshock. The FDA should do everything in its power to discourage the use of electroshock by:

  • keeping ECT’s Class III, high-risk rating;
  • insisting that electroshock psychiatrists, manufacturers of ECT devices, and executives and administrators in hospitals where ECT is administered, substantiate with scientific proof their claims that the procedure is “safe and effective”; and
  • calling upon the Congress and the Department of Justice to investigate the fraudulent and coercive use of this cruel and inhuman procedure.


Alpers, B.J., Hughes, J. (April 1942). “The Brain Changes in Electrically Induced Convulsions in the Human,” Journal of Neuropathology and Experimental Neurology, pp. 172-177.

American Psychiatric Association. Electroconvulsive Therapy (Task Force Report 14). (1978). Washington, DC: Author, p. 4.

American Psychiatric Association (A Task Force Report). (2001). The Practice of Electroconvulsive Therapy: Recommendations for Treatment, Training, and Privileging (2nd Edition). Washington, DC: Author.

Andre, L. (2009). Doctors of Deception: What They Don’t Want You to Know About Shock Treatment. New Brunswick, New Jersey: RutgersUniversity Press, p. 2.

Black, D.W., Winokur, G. et al. (September 1989). “Does Treatment Influence Mortality in Depressives?: A Follow-up of 1076 Patients with Major Affective Disorders,” Annals of Clinical Psychiatry, vol. 1, no. 3, pp. 165-173.

Breggin, P.R. (1998). “Electroshock: Scientific, Ethical, and Political Issues,” International Journal of Risk & Safety in Medicine, vol. 11, pp. 5-40.

Cameron, D.O. (Winter-Spring 1994). “ECT: Sham Statistics, the Myth of Convulsive Therapy, and the Case for Consumer Misinformation,” Journal of Mind and Behavior, vol. 15, no. 1-2, pp. 177-198.

Coleman, L. (1978). Introduction to Frank, L.R. (Ed.), The History of Shock Treatment, San Francisco: Author, p. xiii.

Fink, M. (January-February, 1978). “Efficacy and Safety of Induced Seizures (EST) in Man,” Comprehensive Psychiatry, pp. 1-18.

Fink, M. (1999). Electroshock: Restoring the Mind, New York: OxfordUniversity Press, p. 12.

Frank, L.R. (Ed.). (1978). The History of Shock Treatment. San Francisco: Author.

Frank, L.R. (Spring 2002). “Electroshock: A Crime Against the Spirit,” Ethical Human Sciences and Services, pp. 63-71.

Frank, L.R. (2006). The Electroshock Quotationary (an e-book).

Frank, L.R. (Ed.). (2007). “Electroshock and Death” (an internet posting).

Hoch, P.H. (1948). “Discussion and Concluding Remarks,” Journal of Personality, vol. 17, p. 48.

Impastato, D.J. (July 1957). “Prevention of Fatalities in Electroshock Therapy,” Diseases of the Nervous System, p. 31. This 42-page report of 254 deaths is the largest and most detailed study of ECT deaths ever published. It is rarely cited in the writings of ECT proponents.

Kroessler, D., Fogel, B.S. (Winter 1993). “Electroconvulsive Therapy for Major Depression in the Oldest Old,” American Journal of Geriatric Psychiatry, pp. 30-37.

McCall, W.V., Reboussin, D.M. et al. (May 2000). “Titrated Moderately Suprathreshold vs Fixed High-Dose Right Unilateral Electroconvulsive Therapy,” Archives of General Psychiatry, May 2000, pp. 438-444.

Morgan, R.F. (Ed.) (1999). Electroshock: The Case Against. Mangilao, Guam: Morgan Foundation Publishers.

Polk, H.L. (August 1, 1993). Letter to the editor, New York Times.

Rymer, R. (March-April 1989). “Electroshock,” Hippocrates, p. 71.

Sackeim, H.A., Haskett, R.F. et al. (March 14, 2001). “Continuation Pharmacotherapy in the Prevention of Relapse Following Electroconvulsive Therapy” (abstract), Journal of the American Medical Association, pp. 1299-1307.

Sackeim, H.A., Prudic, J. (January 2007). “The Cognitive Effects of Electroconvulsive Therapy in Community Settings,” Neuropsychopharmacology, pp. 244-254.

Saltzman, C., Konikov, W. et al. (May 1955). “Modification of Electroshock Therapy by Succinylcholine Chloride,” Diseases of the Nervous System, p. 154.

Sament, S. (March 1983). Letter to the editor, Clinical Psychiatry News. p. 11.

Smith, M. (March 7, 1995). “Eight in Texas Die after Shock Therapy in 15-Month Period,” Houston Chronicle, pp. 1A, 6A.

Leonard Roy Frank

Year End, New Year in Review


The MOTHERS Act in Health Care Bill Heads To Final Negotiations & Susan Stone’s False Statement About Melanie Stokes

Why The MOTHERS Act Should Not Become Law


Go directly to the FDA web comment page about electroshock here:

At least say:

“I oppose the FDA’s proposed reclassification of the ECT device to
Class II. The FDA should investigate the ECT device for safety and
effectiveness. The FDA should call for Pre-Market Approval
Applications for the device.”

Electroshock Survivor Leonard Roy Frank to FDA: Case Against ECT

FDA – “Yes Man” to Electroshock?

Pharmalot’s take on the new study on meds during pregnancy being initiated by the FDA and others (FDA to look at medication safety during pregnancy)

Motherhood is Not A Medical Disorder, one of the top posts of the year on Psychiatrist Dr. Doug Bremner’s blog Before You Take That Pill.

Antidepressants no more effective than a sugar pill

Before You Take That Antidepressant, Visit This Website (Op Ed News Re: SSRI Stories)

Ritalin Use Linked With 500% Increase in Sudden Death of Children

Psychiatrist Under Federal Investigation After Writing 96,685 psych drug prescriptions- about 153 per day

Advocates Want New Rules to Protect Nursing Home Patients from Abuse with Antipsychotics



FDA To Evaluate Safety of ECT

I’m in shock. Really in shock. I never thought I’d see this.

It may come as a shock to some of you; but, Shock machines have never been approved by the FDA for safety or efficacy. These were “grandfathered” into the system when the FDA assumed jurisdiction over these items in 1976.

All machines manufactured after this date were routinely approved, as were things like female condoms, on a statement by the manufacturer that these were “Substantially equivalent” to the earlier devices.

This week the Agency told the makers of 25 different types of medical devices marketed before 1976, to submit safety and effectiveness data within 120 days. Electroconvulsive therapy devices are included. <see blog below WSJ article>

The ECT makers must submit proof of safety and efficacy to the FDA by August, 7, 2009. If the data submitted is not up to par, the FDA intends require manufacturers to undergo the more-rigorous premarket approval process for their existing devices, as well as new ones. For some mysterious reason, Congress ordered the FDA to do this in 1990. . . . . but it NEVER HAPPENED!


APRIL 8, 2009, 6:10 P.M. ET

Medical Devices Face New Scrutiny From FDA

The Food and Drug Administration asked several medical-device makers to justify their products’ safety and effectiveness, as part of a move to require tougher evidence standards before products can be sold.

The request covers automatic external heart defibrillators from Medtronic Inc., Royal Philips Electronics NV and Zoll Medical Corp.; dialysis catheters from Covidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; a heart pump from Abiomed Inc.; and several other categories of products.

The move presents the possibility that the companies will have to pay for expensive clinical trials for products already on the market, unless they can persuade the agency to reclassify them as less risky.

The agency’s request comes in response to a 1990 order from Congress that directed the FDA to gather rigorous evidence before a manufacturer can sell medical devices considered to be in the most risky category, known as Class 3.

But despite several attempts during the 1990s, the FDA hasn’t finished implementing the law. In the past five years, it allowed hundreds of new Class 3 devices to be sold based on a less rigorous showing — called a 510(k), after a section of federal law — that they are “substantially equivalent” to combinations of other products marketed before 1976. Such evidence often is collected in a laboratory, not with a clinical trial in patients.

The Government Accountability Office criticized the delay in January. The agency said it will issue regulations Thursday asking makers of high-risk medical devices who had been allowed under the easier process to submit evidence to the agency backing their products’ safety and effectiveness.

The FDA will then either reclassify the devices into a less-risky category in which the 510(k) process is routinely allowed, it said, or require manufacturers to undergo the more-rigorous premarket approval process for their existing devices, as well as new ones.
Mary Long, an agency spokeswoman, said it could take several years for the agency to finish the process. Manufacturers would be granted a grace period to submit enough evidence backing their devices under the more-rigorous standard. “It is a priority, but it will really depend on the kind and amount of information we get on each type,” she said.

Write to Keith J. Winstein at

FDA to Complete “Unfinished Business” of Device Classification & Call for PMAs

By Jennifer B. Davis –

The April 9, 2009 Federal Register will contain the official notice of an FDA order requiring manufacturers of 25 types of Class III “preamendments” devices to submit information on such devices, including adverse safety and effectiveness data not already submitted to the agency, by August 7, 2009. The order also applies to manufacturers of devices marketed based on 510(k) determinations of “substantial equivalence” to the 25 identified preamendments devices. FDA warns that failure to comply is a prohibited act, and will cause any affected device to be to be misbranded. The agency also says it “does not anticipate extending the time for submitting the required information,” and “will use its enforcement powers to deter noncompliance.” FDA intends to use the information submitted to decide the final classification for such devices.

A news release posted on April 8, 2009 on the agency’s website calls the order a “first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress.” The FDA Amendments Act of 2007 ordered GAO to study FDA’s 510(k) process. The GAO report found that the agency’s process for reclassifying or requiring PMAs for class III devices was incomplete, and recommended completion of that task to ensure the most stringent (PMA) review process for high-risk devices.

Section 513 of the FDC Act (21 U.S.C. § 360c), added by the Medical Device Amendments of 1976 (“MDA”), requires FDA to classify all devices into one of three risk-based categories: Class I, Class II, or Class III. Devices assigned to Class III, representing the highest risk, must obtain premarket approval from the agency before they can be marketed. 21 U.S.C. § 360e(a). However, under section 515(b)(1) of the Act (21 U.S.C. § 360e(b)(1)), devices initially assigned to Class III, which were marketed prior to the May 28, 1976 enactment of the MDA – so-called “preamendments” devices, do not require submission of a premarket approval application (“PMA”) until after FDA issues a final rule requiring a PMA for that device, or, FDA publishes a final classification placing the device in Class III. In addition, the statute allows devices introduced to the market on or after May 28, 1976, which can be shown to be “substantially equivalent” to a Class III pramendments device, to be marketed through a 510(k) instead of a PMA unless and until FDA calls for a PMA, or finally classifies the preamendments device in Class III.

As of May 1994, there were approximately 149 preamendments devices which FDA had initially classified or proposed to classify in Class III. The agency has since reclassified (into Class I or II), or published a regulation requiring PMA submission for 122 of those devices, leaving 27. The order to be published in the April 9, 2009 Federal Register addresses the following 25 devices. (FDA has already initiated the process for the other two devices.)

1. 21 CFR 868.5610 Membrane lung for long-term pulmonary support.
2. 21 CFR 870.3535 Intra-aortic balloon and control system.
3. 21 CFR 870.3545 Ventricular bypass (assist) device.
4. 21 CFR 870.3600 External pacemaker pulse generator.
5. 21 CFR 870.3610 Implantable pacemaker pulse generator.
6. 21 CFR 870.3680(b) Cardiovascular permanent pacemaker electrode.
7. 21 CFR 870.3700 Pacemaker programmers.
8. 21 CFR 870.3710 Pacemaker repair or replacement material.
9. 21 CFR 870.4360 Nonroller-type cardiopulmonary bypass blood pump.
10. 21 CFR 870.5200 External cardiac compressor.
11. 21 CFR 870.5225 External counter-pulsating device.
12. 21 CFR 870.5310 Automated external defibrillator.
13. 21 CFR 872.3640(b)(2) Endosseous dental implant (blade form).
14. 21 CFR 872.3960 Mandibular condyle prosthesis (temporary implant).
15. 21 CFR 876.5540(b)(1) Implanted blood access device.
16. 21 CFR 876.5870 Sorbent hemoperfusion system.
17. 21 CFR 882.5800 Cranial electrotherapy stimulator.
18. 21 CFR 882.5940 Electroconvulsive therapy device.
19. 21 CFR 884.5330 Female condom.
20. 21 CFR 888.3070(b)(2) Pedicle screw spinal system (certain uses).
21. 21 CFR 888.3320 Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis.
22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses).
24. 21 CFR 890.5525(b) Iontophoresis device (certain uses).
25. 892.1990 Transilluminator for breast evaluation.

Manufacturers of the above-listed devices must, by August 7, submit “a summary of, and citation to, any information known or otherwise available to them respecting the devices, including adverse safety and effectiveness data that has not been submitted under section 519 of the act” (e.g., medical device reports, reports of corrections and removals). Additional details respecting the format and content for such submissions can be found in FDA’s order.

MOTHERS Act and DBSA – pHARMa Front Group – Who cares about money?


This research was conducted by Evelyn Pringle… I hope you can note the inserted comments from her and look below to read my comments, which I’ll leave off the article portion and put in the comment box.

Depression and Bipolar Support Alliance

2005 Annual Report

Sue Bergeson, President, DBSA


Wyeth Pharmaceuticals

LEADERSHIP CIRCLE ($150,000-$499,999)

Abbott Laboratories
AstraZeneca Pharmaceuticals
Bristol-Myers Squibb Company
Cyberonics, Inc.
Eli Lilly and Company Foundation
Pfizer Inc

FOUNDERS CLUB ($10,000-149,999)

Forest Laboratories
Janssen Pharmaceutica Products
Neuronetics, Inc.
Shire Pharmaceuticals Group

ADVOCATE COUNCIL ($5,000-9,999)

Dr. and Mrs. Edward M. Scolnick

PLATINUM ($1,000-4,999)

Merck & Co. Inc.
Lori L. Altshuler, M.D.
Kay Redfield Jamison, Ph.D.
A. John Rush, M.D.
Mr. Robert C. Schwartz

GOLD ($500-999)

Dr. and Mrs. Mark S. Bauer
Gregory Simon, M.D.

SILVER ($150-499)

Johnson and Johnson
Joseph Biederman, M.D.

Linda L. Carpenter, M.D.
Dr. Ron C. Melzer
National Association of Boards of Pharmacy
Charles O’Brien, M.D.


Merck & Co. Inc
Pfizer Foundation


Abbott Laboratories



Drug company money to Depression and Bipolar Support Alliance in 2006

(Evelyn’s note:

The 2006 Annual Report for the Depression and Bipolar Support Alliance shows that AstraZeneca gave the group more than $500,000 in 2006. Companies that gave between $150,000 and $499,000 included Abbott Laboratories, Bristol-Myers Squibb and Wyeth Pharmaceuticals. Forest Laboratories, GlaxoSmithKline, Janssen, Pfizer, and Shire Pharmaceuticals each gave between $10,000 and $149,000.)

2006 Annual Report



Depression and Bipolar Alliance

Annual Report

This list reflects donations received through December 31, 2007.

LEADERSHIP CIRCLE ($150,000-$499,999)

Pfizer Inc
Wyeth Pharmaceuticals

FOUNDERS CLUB ($10,000-149,999)

Abbott Laboratories
Cyberonics, Inc.
Elli Lilly and Company
Forest Laboratories
National Association of State
Mental Health Program Directors
Organon, Inc.
Otsuka American Pharmaceutical, Inc

PLATINUM ($1,000-4,999)

Abbott Laboratories Employee Giving Campaign

GOLD ($500-999)

Lori L Altshuler, MD
David Dunner, MD
Kay Redfield Jamison, PhD
A. J. Rush, MD
Martha Sajatovic, MD
Gregory Simon, MD, MPH
Dr. James Walker

SILVER ($150-499)

Dr. and Mrs. Paul Berkowitz
Joseph Biederman, MD
Dr. Judith A. A. Cook
Dr. and Mrs. Alan Harris
Dr. Roger W. Helfrich
Nada l. Stotland, MD


Abbott Laboratories
Eli Lilly and Company
Organon, Inc.
Pfizer Inc
Wyeth Pharmaceuticals


Abbott Laboratories
Eli Lilly and Company
Merck Partnership for Giving
Pfizer Foundation

2007 at a Glance: How We Met Our Mission

(Among other things listed are):

Promoted Melanie Blocker-Stokes Postpartum Depression Research & Care Act at invitation of Rep. Bobby Rush (D-Ill.)

Promoted MOTHER’s Act at invitation of Sen. Dick Durbin (D-Ill.)

Launched consumer smoking cessation initiative, funded by Robert Wood Johnson
Foundation’s Smoking Cessation Leadership Center

First-ever DBSA Hope Award for lifetime achievement presented to Frederick K.
Goodwin, MD, & Kay Redfield Jamison, PhD

Active in development & promotion of “Depression Is Real” PSA campaign


DBSA 2007 Fall Newsletter “Outreach”

The issue states: “DBSA gratefully acknowledges its Leadership Circle, Organizations that contributed a minimum of $150,000 during 2007.”


Under “Our 2007 Legislative Milestones” it lists:

DBSA was honored to be asked personally by Senator Dick Durbin (D-Ill.) and Representative Bobby Rush (D-Ill.) to help introduce the postpartum legislation in Illinois.


DBSA Spring 2008 Newsletter “Outreach”

The issue states: “DBSA gratefully acknowledges its Leadership Circle, Organizations that contributed a minimum of $150,000 during 2007.”


It also publishes the following message which explains where some of the drug money went:

Speaking Out for New Moms

Six years ago, after giving birth to her first child, a successful 41-year-old sales manager plunged to her death from a Chicago hotel’s 12th floor as firefighters pleaded with her. Melanie Blocker-Stokes took her own life, despite medical help and the support of family and friends.

Melanie’s tragedy soon prompted legislation in both the U.S. House and Senate. If passed, the Melanie-Blocker Stokes Postpartum Depression and Research Act and the MOTHER’s Act will help the families and women afflicted by postpartum depression (PPD) through lifesaving educational programs and screening services.

In January, DBSA sent an Advocacy Alert asking you to write your legislators in support of these PPD bills. Thousands of you sent letters to Congress through our Legislative Action Center (LAC). As time went on, instead of contacting individual legislators, you began to ask specific congressional committees (like the House Committee on Energy and Commerce), to support a vote rather than just a bill.

Unfortunately, rumors and lies began circulating on the Web, as outspoken opponents began asking people not to support these bills. While they called themselves “experts,” none of them had any expertise in mental health or any PPD-related field. They claimed the legislation was just a conspiracy by big pharmaceutical companies to push new moms to take unnecessary medication.

Tell that to the more than 800,000 women who will develop a diagnosable postpartum mood disorder this year! To debunk these myths, on April 8, DBSA sent you another alert marked “Urgent.” Your response has been nothing less than amazing-unprecedented, Web experts tell us! Just nine hours after our alert, you’d sent 1,200 letters to legislators.

In the next two days, you sent 6,300 more. After one month, you’d sent over 15,000 letters speaking out against the PPD rumors! And, for the first time, other groups are proactively joining us.

Organizations and blog sites like Postpartum Support International (PSI), Postpartum Progress, Moms Speak Up, Becoming Me, Beyond Blue and EmpowerHer are linking their readers to our LAC so that even more letters reach Congress.

Did you know that as few as five letters can make a difference in how your legislator votes? Even if you’ve already sent a letter supporting PPD legislation, please send another.

Help us reach the 20,000 mark for letters supporting PPD legislation! Write Congress today at


Some of the drug money funneled through the DBSA is apparently being spent the same way this year by utilizing the postpartum front groups operating on the internet.


Note from Evelyn:

On March 10, 2009, Katherine Stone’s headline on the Postpartum Progress Blog read:

“It’s Petition Signing Time!  Get Out Your Virtual Pen & Support Women with PPD”

Her blog reports “that Susan Stone over at Perinatal Pro is alerting everyone to the new petition created by the Depression and Bipolar Support Alliance to support the Melanie Blocker Stokes MOTHERS Act.  She states that last year’s petition generated more than 24,000 signatures.  The petition has been reintroduced this year to try and get this legislation passed once again.”

The blog carries a live link to an advocacy alert page where “you can scroll down, enter your zip code and generate letters of support in a matter of seconds for the Melanie Blocker Stokes MOTHERS Act that will be sent to your local Congresspeople and Senators.”

Ms Stone further advises: “I just sent my letters.  I know you’re thinking “but I already did that last year.”  Well that was then and this is now.  Do it again.”

MOTHERS Act & Enne Currie, Dirul Lewis – UPDATE

First, an update on Enne Currie. We are still waiting for any information whatsoever on the whereabouts of Dirul Lewis, her son, who was illegally relocated by his captors in the mental health system with the support of the mental health court overseeing his case. Enne is fighting the courts to learn where he has been taken and regain her conservatorship status which was also illegally cancelled without a hearing or a reason. We will update everyone as soon as we get more information. 


Bobby Rush introduced The MOTHERS Act in the House of Representatives on January 6. Today Robert Menendez introduced the bill in the Senate. According to those pushing for the bill The MOTHERS Act also has support from “Senate leadership.”

The UNITE website is in the midst of being rebuilt but we are working on several projects to fight back against this bill and others which threaten the lives and health of innocent Americans. The archives of our website from the past two years have been temporarily published here in case you need to get back to some of that historical information on The MOTHERS Act. I hope to have the new site functioning as soon as possible.

Thanks to E.T. Cook & Associates for getting that site built and helping with the transition. Their time and resources were donated for our cause and the people of America are definitely worth it!

Robert Menendez states in his press release that The MOTHERS Act was close to passing last year, but failed because of one Senator. (Way to ignore the tremendous grassroots efforts of all the Americans who called, faxed, and pounded the pavement traveling to DC to protest this killer bill, Bob!) But when it comes right down to it, close call or not, the truth of the matter is that without railroading legislation through in the dark of night in omnibus bills or voting on this without a debate (as the House of Representatives did), nightmares like The MOTHERS Act would never see the light of day in the U.S. – at least not from any Congress concerned with the well being of innocent citizens. 

The blessing of a few months of extra time without a MOTHERS Act has certainly helped prevent untold numbers of deaths and much unnecessary suffering- and for that, the mothers and children of America owe a debt of gratitude to each and every Senator who voted against cloture for Harry Reid’s Omnibus bill (containing The MOTHERS Act) last Summer.

In light of all the negative press for pHARMa and psychiatrists, criminal convictions against people involved in some of these illegal marketing schemes, billions of dollars in criminal penalties against Lilly for Zyprexa, all the proof of the deadly effects of psychotropic drugs for babies and mothers, and the documented conflicts of interest among those pushing for The MOTHERS Act, I find it amazing that at this point in time, any U.S. Senator has the audacity to promote this bill or anything like it.

I pray that some day soon these politicians will wake up and realize how much harm is caused by psychotropic drugs and electroshock, and that they will stop supporting programs that would certainly bring about more and more deaths of innocent American women and children.

Please – help by spreading our petition around the country and the world. It will take a huge united effort to beat this bill, and your help is needed now more than ever.