October 22, 2006
An article in The Scotsman, titled, “Pfizer Boss Admits:  Our Image Stinks”, reports that a senior Pfizer executive has admitted the drug industry suffers "crippling cynicism" from the public about its motives and the huge profits it makes. Pfizer Vice President of Medical and Regulatory Affairs for Europe, Latin America, Africa and the Middle East, Jack Watters, said drug companies were partly to blame because "they have failed to promote the positive contributions they make to society." 
<< Click here to read more:  http://www.business.scotsman.com/index.cfm?id=1562152006 >>

October 17, 2006
The Associated Press reports that the former FDA Commissioner, Dr. Lester Crawford, who mysteriously resigned last fall just two months after being confirmed as new FDA Commissioner will plead guilty to charges that he lied under oath and hid his ownership of stock in food and drug companies that the FDA regulated. 
<< Click here to read more: www.nytimes.com/2006/10/17/washington/17fda.html >>

October 17, 2006
NY Congressman Maurice Hinchey issued a statement on former FDA Chief conflict of interest calling for "a serious overhaul" of the FDA.

"Senior officials at the FDA have led the agency down a dark road into a state of crisis. Today's court filing against Lester Crawford underscores the fact that the FDA, which is one of the most important protectors of public health and safety, is in need of a serious overhaul. By blatantly ignoring the law on financial holdings and conflicts of interest, Lester Crawford used his position as the head of the FDA to send all the wrong signals to other FDA employees and the American public. It is not possible for the FDA to fairly and impartially regulate the food and drug industries when the commissioner of the agency has a vested financial interest in the results.

"We do not know the full ramifications of Lester Crawford's misbehavior, which is why it is imperative that the HHS Inspector General finalize his investigation. Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical. The American public has the right to know what else Lester Crawford may have done in office that could have lasting, detrimental effects on the FDA. "

Click here to read statement:
www.house.gov/apps/list/press/ny22_hinchey/morenews/101606crawfordcourtfiling.html

October 14, 2006
Newsweek interviews head of FDA’s Center for Drug Evaluation (CDER), Dr. Steven Galson, about the needed changes at the FDA following several recent studies like the stinging findings of FDA's drug safety performance by the Government Accountability Office (GAO), then the Institute of Medicine report (IOM), followed by the recommendations of five highly respected scientists who are former and current members of FDA's drug safety advisory committee. Their recommendations were recently published in the archives of Internal Medicine.
<< Click here to read content of Newsweek interview >>

October 12, 2006
A New York Times article states that the New England Journal of Medicine reports that "the drugs most commonly used to soothe agitation and aggression in people with Alzheimer's disease are no more effective than placebos for most patients, and put them at risk of serious side effects, including confusion, sleepiness and Parkinson's disease-like symptoms, researchers are reporting today."

The drugs tested in the study - Zyprexa from Eli Lilly; Seroquel from AstraZeneca; and Risperdal from Janssen Pharmaceutical - belong to a class of medications known as atypical antipsychotics. The drugs are used to treat schizophrenia and other psychoses, and are commonly prescribed for elderly patients in long-term care facilities.

About a third of the estimated 2.5 million Medicare beneficiaries in US nursing homes have taken the medications, researchers found. And the use of atypical antipsychotics in the elderly accounts for an estimated $2 billion in the annual sales of the drugs, much of the cost paid by Medicare and Medicaid.
<< Click here to read more: http://www.nytimes.com/2006/10/12/health/12dementia.html

October 11, 2006
The recommendations of five highly respected scientists who are former and current members of FDA's drug safety advisory committee regarding the current drug safety system were published in the Archives of Internal Medicine. According to the authors, the current FDA system of regulating drug safety has serious limitations and is in need of changes. The major problems include the following:
1) the design of initial pre-approval studies lets uncommon, serious adverse events go undetected;
2) massive underreporting of adverse events to the FDA post-marketing surveillance system reduces the ability to quantify risk accurately;
3) drug manufacturers do not fulfill the majority of their post-marketing safety study commitments;
4) the FDA lacks authority to pursue sponsors who violate regulations and ignore post-marketing safety study commitments;
5) the public increasingly perceives the FDA as having become too close to the regulated pharmaceutical industry;
6) the FDA’s safety oversight structure is suboptimal; and the FDA’s expertise and resources in drug safety and public health are limited.

To address these problems, they urge Congress, which is ultimately responsible for the FDA’s performance, to implement the following 5 recommendations:
(1) give the FDA more direct legal authority to pursue violations,
(2) authorize the adoption of a conditional drug approval policy, at least for selected drugs,
(3) provide additional financial resources to support the safety operations,
(4) mandate a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety, and
(5) require broader representation of safety experts on the FDA’sadvisory committees.
<<To read the article, click here: http://www.iom.edu/CMS/3793/26341/37329.aspx >>

October 9, 2006
The FDA suspends an ADHD drug safety study that would further review the use of Risperdal in autistic children. A body of scientific evidence--from both pre-and post-marketing study reports—shows that the drug increases the risk of severely disabling adverse drug effects and premature death in adults and children for whom it has been used off-label. The FDA approved expanded use of Johnson & Johnson’s drug, Risperdal (risperidone) approved for treating psychosis in adult patients with schizophrenia and manic-depression (for short term use). FDA approved its use to control aggression and other bad behavior in autistic children. 

The current drug label indicates: “Safety and effectiveness in children have not been established.”  This exceptionally hazardous drug as well as Eli Lilly’s Zyprexa carries a black box warning that Risperdal “increased mortality in the elderly.” Most deaths primarily due to “cardiovascular (e.g., heart failure, sudden death). ”

The drug has no known therapeutic benefit for autism: it is used as a chemical restraint to disable children and control their behavior. J & J acknowledged: “The anti-psychotic drug is not a cure for autism, nor does it treat the condition itself.” According to the FDA’s MedWatch reporting system, they received reports that at least 45 children have been killed by Risperdal and the other ‘atypicals’ between 2000 and 2004. The youngest, a four years old, died of diabetes complications.
<< Click here to read more, LATimesRisperdal.doc >>

October 8, 2006
ELIZABETH J. ROBERTS, a psychiatrist who treats children and adolescents and the author of Should You Medicate Your Child's Mind?'' published an editorial in The Washington Post. In this article, she states, "The changes I've seen in the practice of child psychiatry are shocking. Psychiatrists now misdiagnose and overmedicate children for ordinary defiance and misbehavior. Temper tantrums are increasingly being characterized as psychiatric illnesses. Using such diagnoses as bipolar disorder, attention-deficit hyperactivity disorder (ADHD) and Asperger's, doctors are justifying the sedation of difficult kids with powerful psychiatric drugs that may have serious, permanent or even lethal side effects."
<< Click here to read the article:
http://www.washingtonpost.com/wp-dyn/content/article/2006/10/06/AR2006100601391.html

October 4-5, 2006
Hofstra University Law School holds a two-day conference debating the impact of conflicts of interest on medicine. An impressive array of speakers whose strongly held opposing views will address key issues in the current heated debate about: The Pharmaceutical Industry and Its Relationship With Government, Academia, Physicians and Consumers.

The timely topics to be addressed:

- Has funding of biomedical research by the pharmaceutical industry affected the reliability of information derived from that research?

- How does industry funding affect the integrity of the research, researchers, Academic institutions, government agencies, physicians, professional organizations, medical journals?

 - How does the law protect the credibility of information from industry-funded biomedical research?

**Click here for agenda and list of speakers, http://www.hofstra.edu/pdf/law_biomed.pdf
**Click here to read one attendees notes from the conference:  verasnotes.doc

September 30, 2006
A front page article in The New York Times reports: "Bayer AG, the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke.”

The Times reports that despite Bayer's failure to reveal the results: "Nevertheless, the agency did not change its advice about whether patients should be given the drug. Instead, it restated previous warnings that Trasylol's use should be limited to patients in whom the risks of blood loss outweighed the drug's risks."  
<< Click here to read article: NYTBayer.doc >>

September 22, 2006
The long awaited Institute of Medicine (IOM) report on the FDA was made public. The IOM, a nonprofit organization created by Congress to advise the federal government on health issues, conducted the study at the request of the FDA.

The New York Times reports that according to the long-anticipated study of the FDA, the IOM finds that the nation’s system for approving and monitoring the safety of medicines is inadequate and needs far-reaching reforms, and the FDA is plagued with poor management and persistent internal squabbling. The IOM report is likely to intensify a debate about the safety of the nation’s drug supply and the adequacy of the FDA’s oversight. The debate began when Merck  withdrew its popular arthritis drug, Vioxx.

The IOM panel made important recommendations that would put the agency back on track to fulfill its mission of protecting the public health instead of industry's cash flow:

- Put a symbol on the packages of new drugs to denote that the medicine's benefits and risks may not be fully understood. It would remain in  pace  for two years.
- Ban advertising directed at patients during that two-year period.
- Review the risks and benefits of all new drugs after five years.
- Bolster the Food and Drug Administration's safety staff and give it an integral role in drug approval.
- Give FDA legal authority to order drug companies to conduct safety studies and to institute other precautions to protect patients.
- Modernize and extend the FDA's databases for tracking serious reactions to prescription drugs.
- Create an internet registry to post results of clinical drug trials.
- Adopt stronger policies to minimize conflicts of interest among outside advisors who serve on the panels that guide much of the FDA's  work.
- Establish a six-year term for the FDA Commissioner, who now serves at the pleasure of the President, to provide stable leadership.
<< Click here to download the IOM report: http://www.iom.edu/ CMS/3793/26341/37329.aspx >>

September 13, 2006
During the latest Congressional hearing probing the conduct of NIH scientists and administrators, Congressman Joe Barton, Chairman of the House Energy and Commerce Committee, rendered a stinging appraisal of the NIH today: "This is really an ethical Potemkin village, where a hollow system appears to provide the illusion of integrity, but transgressors never leave." 

The hearing was the sixth since January 2004, focusing on the scientists' refusal to give up their competing business ventures while employed as public servants. Specifically, the focus of this hearing was the agency's failure to take action following an investigation of conflicts of interest by an NIH appointed panel. Despite the panel's recommendation to terminate two senior NIH scientists whose activities on behalf of drug companies tainted their government research constituting, "serious misconduct" and violation of federal law and regulation, no action has been taken.

The Los Angeles Times reports:   "A congressional subcommittee chairman and a top administrator of the National Institutes of Health agreed on at least one point Wednesday: Private financial deals between drug companies and NIH scientists that have come to light in recent years have posed the worst scandal in the agency's history."
<< Click here to read more: LATimesNIH.doc >>

The Associated Press reports: "Most of the federal scientists who improperly accepted personal money from drug or biotechnology companies walked away with reprimands or were allowed to retire unscathed. Only two of the 44 scientists found to have violated rules governing private consulting deals are being investigated for possible criminal activity, and they remain on the government payroll."
<< Click here to read more: Associated Press NIH.doc >>

September 12, 2006
The New York Times reports that Stanford University to ban drug makers’ gifts to doctors. Stanford University announced that it is adopting a strict conflicts of interest policy. Following a series of investigative reports by Paul Jacobs in The San Jose Mercury News, documenting financial conflicts of interest by 700 of the medical school faculty as well as the school’s department heads, and administrators, Stanford announced its new policy. The policy is intended to limit industry influence on patient care and doctor education. No more free lunches, no more free drug samples.

The New York Times reports, “the new policy does not cover consulting agreements between faculty members and companies aimed at developing drugs or medical devices. Those are governed by an existing conflict-of-interest policy. Such interactions are especially important at Stanford, where many professors have been involved in starting or advising companies in nearby Silicon Valley.”
<< Click here to read article: NYTStanford.doc >>

September 11, 2006
The Associated Press reports that UK pharmaceutical giant, GlaxoSmithKline, has settled the largest tax dispute in IRS history.  GSK shareholders will have to shell out $3.4 billion to settle with the IRS. The dispute involved transfer pricing, an illegal accounting scheme for evading US income tax.
<< Click here to read the article: APGlaxo.doc>>

September 11, 2006
Canadian Free Press runs a story involving a former pharmaceutical sales rep who is blowing the whistle on the hazards of psychotropic drugs in her book, Confessions of an Rx Drug Pusher: God's Call to Loving Arms.  Her own niece set herself on fire after inability to get off an antidepressant.

Author Gwen Olsen is warning parents of the dangers of some antidepressants and psychotropic drugs. After spending 15 years in the pharmaceutical industry, selling some of the drugs she now says can be deadly, Olsen has blown the whistle on her old employers and published her book. "I had a moral responsibility to tell people everything I knew”, said Olsen.
<< Click here to read the article: Freepress.doc >>

September 2006
A new website -- www.ssristories.com has been launched providing public access to more than 1,000 news reports, mainly criminal in nature, that have appeared in the media or that were part of testimonies before FDA advisory committee meetings in 1991 or 2004. The website creators, Rosie Meysenburg and Sara Bostock note: “Even these 1000 documented stories only represent the tip of an iceberg since most stories do not make it into the media.”
<< Click here to read more: www.ssristories.com >>

September 2006
A scientific review exposes link between antidepressants and violence in an article titled, “Antidepressants and Violence: Problems at the Interface of Medicine and Law,”  by Drs. David Healy, Andrew Herxheimer, and David B. Menkes published in PLoS Medicine. 

This is a scientific review of evidence found in 1) the premarketing controlled clinical trial data submitted by manufacturers to regulatory agencies (MHRA in the UK and FDA in the US); 2) data from the UK Drug Safety Research Unit (DSRU); 3) reports from 1,374 viewers who responded by e-mail after a BBC Panorama broadcast in 2003; and 4) evidence from specific medico-legal cases involving homicide. The authors state, “Our main finding is that unselected sets of placebo-controlled trials of antidepressants show evidence for an increased relative risk of aggressive behaviours on treatment, although such outcomes apply to only a small subset of patients.” Manufacturers, with support from high ranking regulatory agency officials, have for years denied evidence of drug-related risks of harm, and downplayed the significance of a unique adverse drug effect profile of second generation psychotropic drugs. In contrast to the older tricyclic antidepressants, SSRIs induce akathisia, emotional disinhibition, emotional blunting, and manic or psychotic reactions. The authors suggest that it is these drugs’ recognized mechanisms of action—not an underlying condition—that may trigger violence: “There is good evidence that antidepressant treatment can induce problems such as these and a prima facie case that akathisia, emotional blunting, and manic or psychotic reactions might lead to violence.” The signs of violence and suicidality were there since the first SSRI antidepressant, Prozac (fluoxetine) was tested in pre-marketing trials.
<< Click here for article: http://medicine.plosjournals.org/archive/15491676/3/9/pdf/10.1371_journal.pmed.0030372-L.pdf 

September 8, 2006
PBS launches a new investigative series whose first report, “A Bitter Pill” airs based on the November 2005 Bloomberg Markets Magazine documenting corruption at every level of current practices. Bloomberg News report titled, ‘Big Pharma’s Shameful Secret" is a ground breaking, six-part investigative report. The team of Bloomberg reporters--David Evans, Liz Willen and Mike Smith--won the prestigious Polk Award for their investigative reporting. Check your local PBS station for date and time.
<< Click here to see first of six-part report of Big Pharma's Shameful Secret with links to entire series: http://www.ahrp.org/cms/content/view/335/29/

September 1, 2006
Science magazine reports that the editor of American College of Neuropsychopharmacology (ACNP) journal -- Neuropsychopharmacology will relinquish his post following a stir over his failure to list commercial ties in a July article about a new treatment for depression on which he was primary author.
<< Click here to read more: SCIENCE.doc >>

September 1, 2006
Wall Street Journal article titled, “Drug Firms Use Financial Clout to Push Industry Agenda at FDA” describes the transformation of the FDA from watchdog to lapdog. It all started with the passage of the Prescription Drug User Fee Act passed in 1992. "For most of its history, the FDA was funded entirely by Congress. But in the early 1990s, companies unhappy with the pace of drug approvals agreed to pay the FDA millions of dollars in annual fees to help speed its performance. Because the industry and the agency renegotiate every five years over the size of fees -- and what they can be used for -- drug makers can have considerable input into which programs receive funding." Wall Street Journal’s Anna Wilde Mathews reports: "In fiscal 1993, the industry's $8.9 million in user-fee money accounted for just 7% of the FDA's drug review budget. The deal has since been renewed twice, with fees increased both times. The $232 million in fiscal 2004 represented 53% of the total drug-review budget."
FDA officials have been huddling at the bargaining table with the pharmaceutical and biotech trade organizations--PhRMA and BIO--"bargaining with the pharmaceutical industry for an increase in fees, giving the industry a greater role in shaping the priorities of its regulator."

August 30, 2006
Associated Press reports that Schering-Plough is the latest drug company to plead guilty to conspiracy and overcharging Medicaid. Schering-Plough were fined $435 million for promoting off-label use of their drugs.
<< Click here to read more: APSchering.doc >>

August 29, 2006
The Scientist’s follow-up to news report about the conflict of interest scandal that has engulfed not only Dr. Charles Nemeroff, former president and editor in chief of the official Journal of the American College of Neuropsychopharmacology, but the College itself.
<< Click here to read more: www.the-scientist.com/news/daily/24445/ >>

August 23, 2006
USA Today reports that last year the pharmaceutical industry "faced the most product liability lawsuits of any other industry." Lawsuits against pharmaceutical companies totaled 17, 027 last year, more than all other industries with significant liability suits combined: 3,236 (Manufacturing); 2,875 (Chemicals); 2,717 (Construction); 2,636 (Financial services); and 1,926 (Insurance).

"The lawsuits," says researcher Thomson West,  "raise questions about whether drugmakers and the FDA pay ample attention to patient safety. Since 2000, more than 65,000 product liability lawsuits have been filed against prescription drugmakers, the most of any industry."  No one even knows how many people have died as a result. The fact that FDA does not prevent lethal drugs from being brought to market and that FDA allows such drugs to be aggressively advertised-even when their deadly effects are known to the FDA-have resulted in such lethal drugs to become the most profitable blockbusters. The profitability of lethal drugs has encouraged companies to market toxic drugs. Drug company profits far outweigh the cost of defending against product liability lawsuits.


August 22, 2006
The New York Times reports that after months of foot dragging, the FDA has finally issued additional warnings on the labels of widely prescribed psychostimulant drugs--Ritalin, Adderall, Concerta.

These drugs are prescribed for at least 4 million people (mostly children) who are diagnosed with the controversial "condition"-- . “The new warnings are not as strong as those approved in February by an advisory committee for the FDA, but they significantly strengthen the risk information already on the drugs."
<< Click here to read more: NYTFDAWARNING.doc >>

August 11, 2006
The Indianapolis Star reports that 8, 362 consumers of Eli Lilly's top-selling drug, Zypreza that produces diabetes--among other life-threatening effects--can expect between $5,000 to "well over $100,000 a person" depending upon the harm suffered. Eli Lilly’s $700 million settlement covered about 75 percent of the known Zyprexa claims against Lilly. But hundreds more have flooded into federal and state courts. Lilly has set aside another $300 million to cover potential liability from the unsettled cases, which it has said it will fight in court.
<< Click here to read more: INDY STAR.doc >>

August 8, 2006
The Boston Globe report focuses on three recent reports in the Journal of the American Medical Association (JAMA) by Harvard researchers who violated the journal’s disclosure policy by failing to disclose their financial ties to companies that had the most to gain from their purported findings. Leading researchers from powerful and prestigious academic institutions routinely fail to disclose conflicts of interest to readers of JAMA and other leading medical journals. The article notes, “At issue is the danger that researchers who receive money from for-profit companies -- whether for speaking fees, consulting, or conducting drug trials -- may, consciously or unconsciously, be biased by that money.”
<< Click here to read more: Globe.doc >>

August 7, 2006
An article titled, Antipsychotic Therapy for Childhood Schizophrenia Lacks Evidence Base: Child and Adolescent Psychiatry Viewpoint, ran in Medscape Psychiatry & Mental Health.

The FDA has not approved any antipsychotic drugs for treating childhood schizophrenia, yet clinicians routinely use medications for this disorder. The authors reviewed a meta-analysis of first generation neuroleptics / antipsychotics (FGAs--e.g., Haldol, thorazine) vs. Second generation so-called 'atypical antipsychotics' (SGAs--Zyprexa, Risperdal, Seroquel, others). Industry's blockbuster sellers--the atypical antipsychotics performed WORSE than their cheaper, non-patented precursors. And the atypicals had MORE adverse side-effects such as, acute weight gain and somnolence.  Both the typical (FGAs) and the atypical (SGAs) caused extrapyramidal side effects in 57% of children. The authors acknowledge a flaw in the meta-analysis is "exclusion of unpublished data, omission of which may have, conceivably, led to over-estimation of response rates."

August 2006
The Office of the Inspector General (OIG) recently released the results of their report on the FDA’s monitoring of adverse safety reports (ASRs) of marketed drugs.  According to the report, "These latest revelations have further damaged the FDA's reputation, already tarnished after its involvement in high-profile safety lapses such as with Vioxx, the inflammatory drug withdrawn in 2004 after risks of heart attack and stroke were identified, as well as Ketek, an antibiotic found to have links to liver failure that was allegedly approved on the back of fraudulent clinical evidence." The FDA acknowledged its lack of effective management information systems for monitoring post-marketing study commitments.

Here are a few exercpts:
- "FDA cannot readily identify whether or how timely postmarketing study commitments are progressing toward completion."
- "About one-third of ASRs were missing or incomplete."
- "FDA reviewers indicated to us that monitoring postmarketing study commitments is not generally considered a top priority at FDA. Our analysis showed that FDA validated only 30 percent of ASRs submitted in fiscal year 2004; five review divisions did not validate any ASRs"
<< Click here to read the report: http://oig.hhs.gov/oei/reports/oei-01-04-00390.pdf

August 1, 2006
In-Pharma reports the findings from a survey recently released by the Union of Concerned Scientists (UCS). It reports that according to the UCS, the survey “demonstrates a pervasive and dangerous political influence of science at the FDA.” Almost 20% of the nearly 1,000 scientists who responded anonymously to the survey said they had experienced their work manipulated or suppressed, having been "asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in an FDA scientific document."
<< Click here to read more: http://www.in-pharmatechnologist.com/news/ng.asp?n=69555-fda-ucs-survey-viox

July 30, 2006
The American Society of Health System Pharmacists reports that the FDA "directed all makers of ADHD stimulants in May to strengthen the wording in the "Warnings" section of the labeling "with regard to serious cardiovascular events and psychiatric events."
<< Click here to read more: http://www.ashp.org/news/ShowArticle.cfm?cfid=16918989&CFToken=67604765&id=16199

July 29, 2006
A letter published in the British Medical Journal takes the FDA officials to task for scurrying to find ways to protect the manufacturers of tainted drugs they approved without disclosing
life-threatening risks. Instead of coming clean to the public—FDA officials are putting their efforts into burying documented suicides and attempted suicides that occurred in controlled clinical trials of antidepressants.

According to the letter’s author, Dr. David Healy, "In 2003, the FDA first presented an analysis of suicide from clinical trials of antidepressants, most of which had been completed a decade
Previously.  Analyses of suicides and suicide attempts in antidepressants trials had been published previously by others, each showing that antidepressants increased the risk of suicide. This result hid for years behind a statistical smokescreen with the claim that the increased risk of
suicide with antidepressants should be disregarded because it was not "statistically" significant But the FDA, with a database of more than 40,000 patients in trials from all of the antidepressant manufacturers, found an increased risk of suicide with antidepressants that was "statistically significant."

"Instead of concluding that their analysis confirmed the increased risk, which would necessitate warnings on the drugs and admit the fallacy of their pre- emption argument (currently being defended in litigation with millions of dollars hanging in the balance), the FDA concluded that with a few clever statistical adjustments, all of the increased risk disappeared."
<< Click here to read more:  BMJHealy.doc

July 28, 2006
The law firm of Baum Hedlund filed a lawsuit against GlaxoSmithKline, the maker of the antidepressant, Paxil, for causing severe heart defects in the newborn son, of a woman prescribed Paxil during her pregnancy. The risk posed by antidepressants, such as Paxil, Prozac, Zoloft, and the other SSRIs and SNRIs has been documented for years, and this month the FDA issued additional warning advisories about the risk these drugs pose for developing babies in the womb. 
<< Click here to read more: http://www.paxilbirthdefect.com/lawsuit.shtml


July 27, 2006
Bloomberg News reports Forest Laboratories Inc, makers of Lexapro and Celexa, was sued by Utah woman who blames the suicide of her 11 year old daughter on Lexapro.  She hung herself after being on the antidepressant for several weeks.  The suit is one about 24 claiming that Lexapro and Celexa caused patients to attempt or commit suicide.

July 26, 2006
A Seed Magazine article titled, “The FDA is a Cauldron of Discontent” reports on Union of Concerned Scientist survey of FDA scientists findings and features Woody’s story. Reporter Michael Stebbins writes, “Whenever there is a hearing on a health issue on Capitol Hill, patient advocates are asked to present horrifying personal stories of people who've been affected--a very powerful tool to tug at the heartstrings of politicians and staff. Only, it doesn't seem to work when it comes to drug safety. For instance, Woody Witczak's widow, Kim, has traveled to Washington 17 times since her husband died, and yet there has been no serious action on the part of Congress, the FDA leadership or the administration to make sure that scientific findings are not hidden from the public; neither have any steps been taken to ensure that FDA scientists can take action when they see a risk to public health.”
<< Click here to read more: http://www.seedmagazine.com/news/2006/07/the_fda_is_a_cauldron_of_disco.php?page=1

July 21, 2006
Bloomberg News reports that Senator Charles Grassley has asked the Inspector General to investigate collusion between FDA officials and Merck. Citing handwritten notes prepared by a Merck executive document a meeting with FDA division director, Brian Harvey, suggesting a joint effort "to get the message out" to discredit  Dr. David Graham who blew the whistle on the lethal Vioxx effect.  FDA officials then tried to prevent Dr. Graham from testifying in a deposition in the context of Vioxx litigation. Their interference was overruled by the judge.
<< Click here to read more: BloombergGrassley.doc

July 20, 2006
Woody’s widow, Kim Witczak, spoke at press conference held by Union of Concerned Scientists to release the findings of their survey of FDA scientists. Other speakers included: Dr. Francesca Grifo, Senior Scientist and Director, Scientific Integrity Program --Union of Concerned Scientists, and Dr. Susan Wood, former Director of the Office of Women's Health, Food and Drug Administration. Woody’s story was a reminder that these findings have real human life consequences.
<< Click here to read press release: BHPressrelease.doc

July 20, 2006
Union of Concerned Scientists (UCS) released the findings of a survey of  FDA employees (1,000 out of 6,000). The UCS-PEER survey confirms that the integrity of science is being undermined for political and commercial reasons. FDA scientists report being afraid to speak frankly about safety concerns and feel constrained in their roles as scientists.

* Almost one in five (18 percent) of those who responded, "I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document."
* More than three in five (61 percent) knew of cases in which "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."
* Three in five (60 percent) also knew of cases "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions."
* Fifty percent also felt that non-governmental interests (such as advocacy groups) had induced or attempted to induce such changes.
* One-fifth (20 percent) say they "have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials." In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to "provide incomplete, inaccurate, or misleading information."
* Two in five (40 percent) said they could not publicly express "concerns about public health without fear of retaliation." More than a third (36 percent) did not feel they could do so even inside the confines of the agency.
<< Click here to read more on the UCS findings: http://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html

July 20, 2006
The FDA issued new warnings about two additional life-threatening risks induced by SSRI antidepressants: Serotonin Syndrome and Persistent Pulmonary Hypertension in newborn babies.
<< Click here to read the FDA public advisory: http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm

Serotonin Syndrome is another term for drug toxicity (poisoning): FDA described the life-threatening effects of Serotonin Syndrome: “restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea.” Doctors who have been prescribing a combination of SSRIs (or the newer SNRIs, such as Effexor and Cymbalta) and medications for migraine headache have put patients at significant increased risk of drug toxicity (Serotonin Syndrome).

Persistent Pulmonary Hypertension in newborns has been documented for years but the FDA did nothing to warn doctors or the public. A February 2006 report in the New England Journal of Medicine reported a six-fold increased risk for infants.
<< Click here to read more: APMigraine.doc

July 19, 2006
Associated Press reports that following an investigative report in The Wall Street Journal which revealed that psychiatrists from Harvard, UCLA and Emory, whose report published in the American Medial Association (JAMA) urged pregnant women to continue taking antidepressants, had financial interests in making those recommendations.  Dr. Catherine DeAngelis admitted that JAMA published the report without disclosing authors' ties to the manufacturers of the drugs they recommended for pregnant women.
<< Click here to read more: APJama.doc

July 16, 2006
A front page article in The New York Times reports: "The breakfast buffet at Camp Echo starts at a picnic table covered in gingham-patterned oil cloth. Here, children jostle for their morning medications: Zoloft for depression, Abilify for bipolar disorder, Guanfacine for twitchy eyes and a host of medications for attention deficit disorder." The Times reports, 20%  of children in sleep-away-camp take asthma and allergy drugs and "about a quarter of the children at camps are medicated for attention deficit disorder, psychiatric problems or mood disorders." As one camp owner--who does not approve--states "This is the American standard of care now."

The reporter does not question the commercial interests that have resulted in this medically inexplicable practice. Dr. David Fassler, a spokesman for the American Psychiatric Association as well as the American Academy of Child & Adolescent Psychiatry, who invariably reassures the public with unsupported claims:

"Exacting diagnoses and proper treatments enable some children to go to camp who otherwise could not function in that environment, said Dr. David Fassler, a child and adolescent psychiatrist and a professor at the University of Vermont College of Medicine. Dr. Fassler said that children with one behavioral or mood disorder often “have a second or even a third diagnosis.” A child with A.D.D. may also be depressed and anxious, he said, a combination of symptoms that can make such children pariahs in the close quarters of a summer camp cabin without the proper combination of remedies."

The article glosses over the body of evidence showing that psychotropic drugs cause severe, debilitating adverse effects--both physical and mental. They carry FDA-mandated black box warnings for scientific reasons. It notes that "some doctors, nurses, and camp directors are uneasy about giving children so-called off-label drugs.”
<< Click here to read more: NYTcamp.doc

July 2006
The cover story of July/August issue Harvard Magazine, "Psychiatry by Prescription: The Myth of Psychiatric Scientism," by Ashley Pettus, offers much insight by opposing Harvard experts who offer opposing views about the nature and validity of the proliferation of psychiatric diagnoses.

"At the heart of a debate over epidemiological statistics are deep misgivings about the way psychiatry defines and measures mental illness. Despite major advances in the treatment of psychiatric symptoms in recent years, there are still no definitive clinical tests to determine whether someone has a given disorder or not.”

Among those quoted is Dr. Steve Hyman, Harvard University Provost, and Professor of Neurobiology at its Medical School, who served as Director of the National Institute of Mental Health (NIMH), and before that was the Director of Psychiatry Research at Massachusetts General Hospital. Dr. Hyman is a molecular biologist who has specialized in neurotransmitter action--thus, he knows how psychotropic drugs work.

When asked about the level of knowledge about psychiatric diagnoses Dr. Hyman responded:  “We have no equivalent of a blood-pressure cuff or blood test or brain scan that is diagnostic...The DSM IV [psychiatry's diagnostic manual] has not given us validity...The proliferation of disorders in a single person,” he says, “suggests there is something wrong with the number of discrete diagnoses.” 
<< Click here to read more:  http://www.harvardmagazine.com/on-line/070646.html

July 11, 2006
The Wall Street Journal documents how psychiatry’s treatments are shaped by "opinion leaders" whose professional recommendations are compromised by their substantial, largely undisclosed, financial ties to drug companies. The article documents violations of influential academic psychiatrists who promote psychotropic drugs for pregnant women that will cause harm to their developing infants.   Specifically, thirteen leading drug industry-financed psychiatrists from Harvard, UCLA and Emory, published a report in JAMA (2006) whose aggressive promotion in the local and national media was designed to frighten pregnant women and to dissuade them from stopping antidepressants during pregnancy.

The authors emphasized a (previously unreported) risk of relapse, disregarding a body of evidence (documented since 1993) demonstrating that exposure to serotonin (SSRI antidepressants) in utero has caused birth defects, cardiac malformation, respiratory distress, and severe withdrawal syndrome in infants. The authors even disregarded manufacturers’ disclosure on SSRI-SSNRI drug labels which acknowledge that the drugs pose risks of harm to neonates who “have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding."
<< Click here to read more: WSJPregnancy.doc

July 2006
For almost two decades Eli Lilly, manufacturers of the first SSRI Prozac on the market, has denied that evidence exists demonstrating that its antidepressant Prozac induced violence and suicidality.

Baum Hedlund reproduces the time-line presented to the jury in the Forsyth v. Eli Lilly Trial during closing arguments by the plaintiffs. The time-line comes from Lilly's internal documents. The plaintiffs alleged that the documents show that Lilly knew about Prozac-induced suicidality and violence (even before Prozac was approved for marketing in the United States) and that this vital information was withheld from clinicians and the public. 
<< Click here to read more: EliLillyTimeline.doc

July 2006
An PLoS article titled, “Do Antidepressants Cure or Create Abnormal Brain States?’ by Dr. Joanna Moncrieff of University College London and Professor David Cohen of Florida International University in Miami, challenge the "disease-based" paradigm in psychiatry, arguing that the class of drugs known as antidepressants, and indeed all psychotropic drugs, produce their desired effects by creating abnormal brain states.   Psychotropic drugs induce sedation, or stimulation, or indifference, or a "plethora of psychobiological states," and may thus coincidentally relieve symptoms of psychiatric disorders. The authors write that this in no way suggests that patients have "chemical imbalances" and they warn that these drug-induced states, though usually short-lived and may create more problems than they solve. Drs. Moncrieff and Cohen argue that psychiatry's dominant "disease-centered model"-which holds that drugs correct "biochemical imbalances"-is far from established
<< Click here to read more: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10%2E1371%2Fjournal%2Epmed%2E0030240

June 29, 2006
Consumer union holds press event with members of Congress and family
members who lost loved ones to highlight stalled FDA improvement
legislation. << Click here to read more >>

June 26, 2006
BBC reports that top pharmaceutical companies are using unscrupulous marketing practices to promote their drugs, according to a European Consumer International report. The industry uses unscrupulous, systemic promotional practices to influence opinion and prescribing practices. "These include the sponsoring of patient lobby groups, funding disease awareness campaigns and use of hospitality packages for medical experts." Industry's claims about the cost of research and development are contradicted by industry's spending on marketing:  "The pharmaceutical industry spends nearly twice as much on marketing as it does on research and development, yet consumers know next to nothing about where [$60 Billion] this money is going."
<< Click here to read more: http://news.bbc.co.uk/go/pr/fr/-/2/hi/europe/5116312.stm

May 26, 2006
Health Canada warns heart patients to AVOID ADHD drugs. "All ADHD drugs stimulate the heart and blood vessels ... The effects are usually mild or moderate, but in some patients this stimulation may -- in rare cases -- result in cardiac arrests, strokes or death," said Health Canada.
<< Click here to read more: HealthCanadaADHD.doc
<< Click here to read what the FDA is doing on this issue:
http://www.ahrp.org/cms/content/view/176/28/

May 26, 2006
The Associated Press reports that the U.S. Centers for Disease Control and
Prevention has issued a report estimating that nearly 3,100 people prescribed psychostimulants--such as, Ritalin, Concerta and Adderall--landed in hospital emergency rooms! The evidence from clinical practiceconfirms the concerns raised by cardiologists on the basis of clinical trial data.

These drugs are causing children and adults to suffer severe adverseside-effects, including cardiac problems, chest pain, stroke, high bloodpressure and rapid heart beat. The CDC report confirms earlier evidence that children who are prescribed psychoactive drugs--such as stimulants or antidepressants are at increasedrisk of suffering severe adverse drug effects requiring emergency hospitalization.
<< Click here to read more: http://www.ahrp.org/cms/content/view/175/52/

May 26, 2006
GlaxoSmithKlines's acknowledgement refutes the recent claims made in the American Psychiatric Association’s The American Journal of Psychiatry.
In the wake of the extraordinary acknowledgement earlier in month by GlaxoSmithKline that the clinical trial evidence shows that not only children and adolescents are at increased risk of suicidal behavior if they take its antidepressant, Paroxetine / Paxil (or any other "new generation" antidepressant), adults too are at increased risk of suicide if they take Paxil. The risk is six-fold compared to those given a placebo.

May 19, 2006
United Press International reports on the controversial Teen Screen Program which is part of a presidential task force to help prevent teen suicides. It recommends school screening of young school aged children for tell-tale signs of emotional and behavioral trouble.
<< Click here to read more: UPITeenScreen.doc

May 16, 2006
The Wall Street Journal documented report by David Armstrong talks about the illusion about The New England Journal of Medicine as a bastion of scientific and moral integrity.
The evidence brought to light by the WSJ reveals that a culture change at the NEJM mirrors the prevailing culture within the pharmaceutical industry. Neither the scientific integrity of its published reports nor the professional conduct of those who review the reports can be trusted. Among the documents for which the Wall Street Journal provides links, is to a Seattle public radio broadcast ( Aug. 14, 2001) in which pharmacist Jennifer Hrachovec called in and challenged NEJM editor, Dr. Jeffrey Drazen, about the inaccuracy of the published Vioxx-VIGOR study.
<< Click here to read more: http://www.ahrp.org/cms/content/view/168/55/

May 12, 2006
GlaxoSmithKline and the FDA notified healthcare professionals that there is a risk of suicidality in young adults on Paxil.
<< Click here to read more: http://www.ahrp.org/cms/content/view/166/28/
<< Click here to read GlaxoSmithKline letter to healthcare professionals.
<< GSKmay1.jpg
<< GSKmay2.jpg

May 3, 2006
An investigative report in USA Today documents the truth about antipsychotic drug-induced harm being perpetrated on America’s children. Marilyn Elis of USA Today reviewed FDA's Medwatch adverse event report database (from 2000 to 2004) and found "at least 45 deaths of children in which an atypical anti-psychotic was listed as the "primary suspect." One-fourth of the cases in the database did not list the patient's age.  In addition, there were 1,328 reports of bad side effects, some of them life-threatening. The FDA Medwatch database represents only 1% to 10% of drug-induced side effects and deaths. Expert clinical pharmacologist Alastair J.J. Wood (Vandebilt University) suggests it represents, "maybe even less than 1%."
<< Click here to read more: USATODAYmedwatch.doc



April 28, 2006
An article in PLos Medicine (Public Library of Science) reports that disease-mongering turns healthy people into patients, wastes precious resources and causes iatrogenic (medically induced) harm. Like the marketing strategies that drive it, disease-mongering poses a global challenge to those interested in public health, demanding in turn a global response.”
<< Click here to read more: http://collections.plos.org/diseasemongering-2006.php  

April 27, 2006
HBO’s Bill Maher wrote an OpEd piece in The Los Angeles Times, in which he skewers the drug industry's methods of marketing invented “diseases;” doctors who jump at every free (expensive) dinner invitation and honoraria for listening to sales pitches;  and the complicity of the FDA and Congress who, as he says, are also accepting bribes: “Drug companies are pushers, and Congress and the FDA are the cop on the beat who's been paid off to look the other way.” “Just in the last two years, the drugs that have made the headlines under the category "Prescription Medicines That Hurt People" have included Vioxx and Ambien. And yet it was marijuana last week that was declared by the FDA to have no known medical value. Actually, what marijuana has is no known lobbying value.”
<< Click here to read more: http://www.ahrp.org/cms/content/view/159/29/

April 24, 2006
The Government Accountability Office (GAO) released its findings on FDA. According to a Los Angeles Times article titled, “Drug Safety Still Seen as Lagging a Year After announcing Reforms”, the FDA still doesn't have a reliable system to keep track of developing problems. The GAO found that a new Drug Safety Oversight Board and other FDA initiatives were "unlikely to address all the gaps" in the agency's system for monitoring the long-term safety of prescription drugs approved for market.
<< Click here to read more: LATIMESGAO.doc

April 20, 2006
According to an article titled, “Top Mental Health Guide Questioned” in The Chicago Tribune, reports most of the experts who prepared the world's leading medical guide to mental illness (known as the Diagnostic and Statistical Manual of Mental Disorders aka DSM) had undisclosed financial relationships with drug companies that presented potential conflicts of interest. This is according to a new report published Thursday in the Journal Psychotherapy and Psychosomatics. The study is the first to document extensive monetary connections between drug companies, psychiatrists and other scientists responsible for the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders. The DSM, as it's commonly called, defines all the mental illnesses recognized by psychiatry and outlines the criteria used to determine whether a person has one of these conditions. Medical professionals refer to it as the "bible of mental health" in the U.S.
<< Click here to read more: ChicagotribuneDSM.doc

April 14, 2006
The Portland Tribune reports that a study examining Oregon's Medicaid plan found that 246 preschool children are being drugged with toxic anti-psychotics and/or antidepressants.  The drugs are unapproved for use in children under 18, and they carry black box warnings of lethal risks.
<< Click here to read more: http://www.portlandtribune.com/news/story.php?id=34841

April 11 – 13, 2006
The “Disease Mongering” conference will be hosted by the Newcastle Institute of Public Health and School of Medicine and Public Health at the University of Newcastle, Australia.  An international group of experts will address the commercialization of disease and medical conditions, and such public policy issues as: “When does legitimate promotion of public health become mongering of disease for profit?” 
Speakers will also discuss non-medical implications—such as economic and social ramifications of medicating developmental “conditions” and medicalizing normal life experiences.
<< Click here to read more: http://www.diseasemongering.org/downloads/program.pdf

Three recent UK press reports address different aspects of the issue:

1) The Times World News: “Drug Companies ‘Inventing Diseases to Boost Their Profits” by Mark Henderson.
Click here to read more: http://www.timesonline.co.uk/article/0,,3-2128371,00.html

2) Guardian: “Glaxo Denies Pushing ‘Lifestyle’ Treatments” by Fiona Walsh
Click here to read more: http://business.guardian.co.uk/story/0,,1763199,00.html

3) Guardian: “Depression is UK's Biggest Social Problem, Government Told” by Sara Boswell
Click here to read more: http://society.guardian.co.uk/print/0,,329467273-106049,00.html

April 1, 2006
An editorial, “Carefully Weigh Drug Firms Claims”, runs in The Shreveport Times that talks about the truths about the pharmaceutical industry and its corrupting influence on high ranking lawmakers and the near-total subversion of the FDA is spreading to the American hinterland.
<< Click here to read: www.shreveporttimes.com/apps/pbcs.dll/article?AID=/20060401/OPINION03/604010311/1007

March 30, 2006
The Center for Public Integrity reports that FDA officials circumvent the prohibition on accepting trips from drug and medical device manufacturers. They accept trips from nonprofit associations "that draw their members, their boards and even some of their funding from medical and pharmaceutical-related companies paying for the travel of hundreds of FDA employees." The major sponsor of FDA staff travel expenditures was the Drug Information Association which paid for more than 600 trips of FDA employees.
<< Click here to read more: publicintegrity.doc

March 23, 2006
A national class action was filed against GlaxoSmithKline for Paxil-induced suicides in youths. The lawsuit charges the company with fraud, negligence, strict liability, and breach of warranty in its marketing of Paxil (Seroxat) by concealing the risk of suicide.
<< Click here to read more: BHpressreleasePaxil.doc

March 16, 2006
The Associated Press reports that a just released study that found that a staggering, two and half million children in the U.S. are being prescribed antipsychotics annually--that's 40 out of every 1,000 children. The released study by Dr. William Cooper of Vanderbilt Children's Hospital found that two and half million children in the U.S. are being prescribed antipsychotics annually. That's 40 out of every 1,000 children are being exposed to highly toxic drugs that have never been approved for use in children.  The drugs damage the central nervous system, the metabolic system, trigger hyperglycemia, acute weight gain, diabetes, cardiac arrest, cognitive impairment, and are linked to insulin suppression in children. The drugs carry black box warnings.
<< Click here to read more: APADHD.doc

March 10, 2006
Dr. Peter Breggin's sealed expert medical report in a Paxil liability case is now in the public domain. Newly released information contained in sealed expert medical witness report demonstrates that the manufacturer of Paxil withheld key data concerning the risks associated with its antidepressant Paxil when taken by adults. 

In a press release issued by Dr. Peter Breggin states,  "The drug company Glaxo SmithKline failed to release its complete data concerning rates of suicidality on Paxil.  In the information that was originally provided to the FDA, the number of suicide attempts on the antidepressant Paxil was under-reported and the number of suicide attempts on placebo was inflated. The drug company also hid the stimulating effects of the drug that pose a potential risk for causing violence."
<< Click here to read more: http://www.breggin.com/courtfiling.pbreggin.2006.pdf

March 2006
The March issue of Oprah magazine contains an article titled, “Valley of the Dulls.”
It reports that a stunning 157 million prescriptions for antidepressants were dispensed in 2005.  Not everyone is helped by antidepressants.  Some complain that the drugs take the edge off their memory, concentration, creativity, and drive.  The article asks, “Are the wrong people getting the medication?”
<< Click here to read more >>


February 22, 2006
An article in Psychiatric Times, titled, “Conservative Groups Press Currie on Teen Screening”, reported about a meeting attended by several "conservative interest groups" of concerned citizens with Charles Currie, the Administrator of the Substance Abuse and Mental Health Services Administration (SAMHSA).

The groups who were represented raised concerns about the government policy of mass mental screening of America's school children—often without valid, informed parental consent. Mental screening is the first step in an orchestrated expansion program that increases patient rolls.  Children who screen "positive" are labeled with psychiatric disorders, followed by prescriptions for psychotropic drugs.

Now the public will have the opportunity to hear the debate between Dr. David Shaffer, head of Child and Adolescent Psychiatry, Columbus University who helped found Teen Screen model and Vera Sharav, founder of AHRP, who opposes Teen Screen. It will be held in Washington DC.
<< To read more, click here >>

February 20, 2006
As reported in the Tacoma News Tribune, the British Medicine and Healthcare Products Regulatory Agency (equivalent to the FDA) has identified new safety concerns with ADHD drug Stattera.  The British authorities have associated Strattera with seizures and a potentially dangerous lengthening of the time between heartbeats, called QT interval prolongation, in a handful of the more than 3.7 million people who have used the drug since it hit the market in November 2002.

The report was obtained by The News Tribune after a Swedish court ordered it released to a drug-safety activist in that country.

Though the number of seizures and heart-rhythm problems is small, the British agency said problems could be under-reported, and warned doctors and consumers that the drug should be used with caution in people prone to such problems. In particular, they warned about potential heart problems when Strattera is combined with antidepressants like Paxil and Prozac.  They are updating the drug’s label in the UK to warn of the possible problems.

Though the FDA and Strattera’s maker, Eli Lilly, are aware of the issues raised by the British authorities, they are being handled differently in the US.    They have stated that no warnings are planned at the moment to U.S. doctors and patients, and the U.S. label for Strattera contains no warning of seizures.
<< Click here to read the article >>

February 15, 2006
A press release reported out of Sweden, a not yet released discussion paper from the British Medicines and Healthcare products Regulatory Agency (MHRA) reveals 130 reports of suicidality in one month from treatment with Strattera.

In addition, the paper tells about 766 spontaneous reports of cardiac disorders and 172 of liver injury, and about 20 completed suicides.

The press release further states Strattera is a failed antidepressant, which Eli Lilly didn’t succeed to get approved. It was recycled and used as an “ADHD medication,” and marketed as the first “non stimulant medication for ADHD.”

February 13, 2006
In a TIME Magazine article, Dr. Steven Hayes concludes that after decades of drug side effects, only marginal gains have been seen in public mental health.   As the article points out: "For a time, in the 1990s, we seemed to think that curing mental illness was a matter of manipulating a couple of brain chemicals. But after decades of side effects and the recent debate over whether antidepressants carry suicide risk for teens, we have seen only marginal gains in public mental health. A 2002 study in Prevention & Treatment found that approximately 80% of the response to the six biggest antidepressants of the '90s was duplicated in control groups who got a sugar pill. So we may be ready for something different."

Also: "Cognitive therapy was also shown to be somewhat superior to antidepressants."

And: "Among more severely depressed patients, behavioral techniques like setting up new routines and scheduling activities worked as well as an antidepressant and significantly better than cognitive therapy.”
<< Click here to read more >>

February 13, 2006
Reuters reports that some outside advisers criticized a major part of the government's efforts to improve drug safety, saying a new drug safety oversight board needs independent voices and should consider meeting in public.  The Drug Safety Oversight Board was announced a year ago as a step to help regulators quickly respond to signs of unexpected side effects after a drug reaches the market.  Currently, board members are senior FDA officials, plus experts from other government agencies. They meet periodically in private to discuss how to address emerging issues. Brief summaries are released to the public.
<< To read more, click here >>

February 13, 2006
In the wake of the fraudulent cloning reports published in the medical journal, Science, a report in the New York Times Business section surveyed science reporters in several major newspapers and found that newspaper reporters are beginning to express doubt about the credibility of reports published in peer-reviewed science journals.

Rob Stein, science reporter of The Washington Post, acknowledged: "My antennae are definitely up since the whole thing unfolded."  The Boston Globe "instituted guidelines last July requiring reporters to ask researchers about their financial ties to studies, and to include that information in resulting articles. In its weekly health and science section, The Globe outlines any shortcomings of a study under the heading ‘Cautions.’”
<<To read more click here >>

February 13, 2006
An Op-Ed piece in The Boston Globe by Dr. Jerome Kassirer, distinguished Professor at Tufts, a former editor of the New England Journal of Medicine, and author of "On the Take: How Medicine's Complicity With Big Business Can Endanger Your Health," writes how drug lobbyists influence doctors and should make taxpayers and Congress stop and consider.

"While lobbying groups spend about $2 billion to convince politicians to do their bidding, pharmaceutical companies spend nearly 10 times that much to influence the nation's 600,000 to 700,000 physicians to prescribe the newest and most expensive drugs. I imagine that many people who regularly watch television assume that the companies are spending most of their advertising budget to influence consumers, but no. Nearly 85-90 percent is spent on doctors, for free drug samples, speaker's fees, consultation fees, and ''educational grants."

So, while much is being written about Big Pharma's lobbying influence on legislators and direct to consumer advertising, the amounts spent on those ads pales when compared to the amount spent by Big Pharma--close to $20 billion--on influencing those who are licensed to write Rx.
<< Click here to read more >>

February 10, 2006
An article in TIME noted that FDA officials at a meeting regarding ADHD medications, such as Ritalin, were taken by surprise when the committee “in an unexpected twist” took safety seriously, reasoning that “the evidence of serious risks was so great that a strong new warning — not just more research — was needed.”

The article reports that cardiologist, Dr. Steven Nissen of the Cleveland Clinic, who was among the early warners on the risks of Vioxx, made a motion for a black box warning on the drugs due to cardiac risk.  He was concerned that the 25 cases of reported deaths might be just the tip of an iceberg. “There’s no mandatory reporting of these cases.”

Dr. Nissen noted that the stimulants in question are known to raise blood pressure and heart rate. “Raising blood pressure of a child or adult continuously over many years worries me,” Nissan told TIME. “There is a linear relationship between increased blood pressure and adverse cardiovascular events.” Nissan further notes that two stimulants that are related to the Ritalin class of drugs—ephedra and phenylpropanolamine (PPA)—have been banned from the market because of cardiovascular risks.”

Another panel member, Dr. Curt Furberg, concurred, stating: it would be "inappropriate, unethical behavior" for the FDA not to disclose to doctors and patients that there was uncertainty about the safety of ADHD drugs.
<< To read more, click here >>

February 10, 2006
Since the passage of a 1995 law under then Governor John Engler, Michigan is the only state in the nation in which citizens are fully prohibited from filing liability claims against drug companies. The prohibition includes state courts and federal courts, individual actions and class actions. And so Michigan citizens (or their survivors) who have been seriously injured or killed by drugs like Redux ("fenphen"), Rezulin, Baycol, or Vioxx—a few of the sixteen drugs that have been withdrawn because of safety problems since 1997—have been shut out of court.
 
As Dr. Henry Greenspan points out in his editorial to Justice Caucus, it’s not about whether a drug "has dangers" or, indeed, may cause serious injury or death. Lawsuits are about a company's "failure to take reasonable and timely action to make a drug’s risks known — above all, to the FDA and to physicians—when that company became aware of those risks.  The goal of immunizing drug and vaccine manufacturers is to protect them from the consequences of their deliberate concealing of the hazards they had knowledge of.”

And, as PhRMA spokesman, Alan Goldhammer, let slip, liability is what leads drug manufacturers to be concerned about safety issues--without the threat of liability, there will be NO INCENTIVE to worry about drug safety issues.
<< Click here to read more >>


February 9, 2006
AP reports Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisors said at the conclusion of their 2-day long meeting.

The FDA advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 people, including 19 children, who had taken ADHD drugs. The vote was 8-7, with one abstention.
<<Click here to read more:>>

February 9, 2006
The Boston Globe reports that the Food and Drug Administration is again considering revising labels of popular antidepressants, this time in response to an article in the New England Journal of Medicine that linked use of drugs like Paxil, Prozac, and Zoloft late in pregnancy with a condition that can endanger infants' lives. The condition is called persistent pulmonary hypertension of the newborn.
The FDA called the results of a study cited in the article "very concerning."   The agency will issue a public health advisory within days, said Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs. Its regulatory options include updating drug labels, searching public and private databases to corroborate the drug link to the lung condition, and requiring additional trials from drug manufacturers.
<< Click here to read more: >>

February 6, 2006
An independent review by a team of German analysts published in the American Journal of Psychiatry confirms that corporate bias is ubiquitous in clinical trials. The credibility of company sponsored tests of the so-called 'atypical' antipsychotic drugs (neuroleptics) including Johnson & Johnson subsidiary Janssen's Risperdal (risperidone), Lilly's Zyprexa (olanzapine), Novartis' Clozaril (clozapine), Pfizer's Geodon (ziprasidone) and Sanofi-Aventis' Solian (amisulpride) is totally undermined by corporate bias at every step of the process--from design, subject selection, data analysis, and journal reports.

Dr. Stephan Heres and colleagues (Technical University, Munich) found that 90% of company-sponsored clinical studies found the company's drug more favorable than its competitors. "Different trials comparing the same two drugs have had contradictory conclusions," the study notes.  The reported results seem to be much like partisan politics—the drug favored depended upon who paid for the trial. A total of 42 clinical trial reports were identified.  Of these, 32 were (fully or partially) funded by pharmaceutical companies.
<<To read the original recap of study as published in The Pink Sheet, click here:>>

February 6, 2006
Weighing the Benefits and Risks of SSRI Antidepressants for Youth
Parents, physicians and the public attempting to make sense of the controversy about antidepressants are torn between unproven claims and counter-claims about the drugs’ benefits and risks.  People cannot make an informed treatment decision unless they know the demonstrated risks and benefits.  Following the FDA-mandated black box warnings (October 2004) of a twofold increased risk of suicidality in children—4% in those on an antidepressant compared to 2% in those on placebo—there was a dramatic 20% to 25% drop in SSRI prescriptions for children under 18.
<<To read more, click here>>

February 2, 2006
An editorial in The New York Times acknowledges what has been noted by some observers for the past decade: "the medical profession has sold its soul in exchange for what can only be described as bribes from the manufacturers of drugs and medical devices."   "It is long past time for leading medical institutions and professional societies to adopt stronger ground rules to control the noxious influence of industry money on what doctors prescribe for their patients."
<<Click here to read more>>

February 2006
CNN Money reports that antidepressant sales have been slowing ever since the 2004 warning went into effect. Deutsche Bank analyst Barbara Ryan wrote that "the antidepressants market remains flattish following suicide relabeling."
<<To read more, click here>>

February 2006
Consumer Union recognizes Woody’s widow and brother-in-law for all their advocacy work on drug safety and antidepressant issues on the national and state level.
<<To read more, click here:>>

February 9-10, 2006
The FDA hearing set to address drug safety issues for ADHD drugs (i.e. Ritalin, Adderal, Concerta) linked to death and heart attacks.

February 1, 2006
Prescription Drug & Pharmaceutical News reports that drug companies like GlaxoSmithKline, Merck, and Sepracor are currently developing a new class of antidepressants called,  "triple reuptake inhibitors."  These new drugs will inhibit the reuptake of serotonin, norepinephrine and dopamine are expected to hit the market in 2009.  According to Natalie Taylor, an analyst with Decision Resources, Inc., a pharmaceutical research and advisory firm,"In order to establish a presences in this market, novel antidepressants drugs will need to be clearly differentiated from the large numbers of generic first line-therapies, and will need to be aggressively marketed to primary care physicians if they are to attain sales that approach the blockbuster status enjoyed by Pfizer's Zoloft and Wyeth's Exfexor." 
<< Click here to read the article >>

January 25, 2006
Stephen Pizzo, an investigative journalist for 25 years compares Big Pharma to Big Tobacco in his article titled, “Shielding Big Pharma”.  He points out:

1) Both Big Tobacco and Big Pharma produce and sell products that often cause injury or death when used as directed.

2) Both industries knew that some of their most profitable products were injuring and killing people, and either hid such evidence, lied about it or both.

3) Both industries hired their own experts to produce often phony, always misleading non-peer-reviewed, “research” designed solely to cast doubt on any genuine research by outside experts that came to conclusions that could hurt sales.

4) Both industries attacked, slandered and punished those within or associated with their industries who broke the company stonewall by trying to sound a warning.

5) Finally, both industries enjoyed overly cozy relationships with government—relationships that enabled them to maximize profits for as long as possible, regardless of the harm such products were known to be causing. (In this regard, Big Pharma has gone even further, by compromising the FDA, the very federal regulatory agency that is supposed to protect consumers.)
<< Click here to read the article >>

January 24, 2006
Consumer Alert, a Portland, OR consumer advocacy group launches anti DTC drug ad website.
They hope to educate the public about the dangers of prescription drug advertising and to mobilize thousands of Americans to voice their opposition to the ads  The FDA is accepting public comment on DTC advertising until February 28, 2006.
<< Click here to check out the site >>
<< Click here to see a sample of Pfizer’s most recent advertising for Zoloft >>

January 19, 2006
The Washington Post reports that the FDA's controversial assertion of "federal preemption" was included as a preamble to long-awaited guidelines designed to make drug-labeling information more accessible and readable for doctors and consumers. Agency officials said that, although the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position. 

According to Scott Gottlieb, FDA’s Deputy Commissioner for Medical and Scientific Affairs, "We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge."
<< To read more, click here >>

January 15, 2005
The Insurance Journal reports that the National Conference of State Legislatures has accused the FDA of attempting to preempt state prescription drug product liability laws despite Congress and the courts’ refusal to grant them such power.  The state group says the agency is trying to expand its own authority by sneaking language into a revised prescription drug labeling rule.
<< Click here to read more >>

January 14, 2006
The Wall Street Journal reports that the FDA's plan for revamping drug labeling rules would carve in stone the agency's former chief counsel, Daniel Troy's pre-emption argument.  The pre-emption argument holds that the authority of the FDA (and other federal regulatory agencies) pre-empts any state consumer protection laws.

Drug companies like Merck would be free from liability even as the body count from its pain killer, Vioxx, reaches tens of thousands.  The White House, drug companies, lobbyists and sycophants are attempting to frame the argument in terms of "tort reform" falsely creating the impression that the only ones who would lose would be plaintiff attorneys. 

In truth, the FDA, whose legal mandate is to protect the public from drugs that have not been scientifically proven safe and effective, is proposing a rule to protect the manufacturers of hazardous drugs instead.
<< Click here to read the PDF >>
<< Click here to read article online >>

January 12, 2006
LA Times reports that in an effort to try and increase the number of new drugs that make it to market, the FDA issued guidelines today allowing investigators to test minute doses of experimental drugs on people, to see if the results are promising enough to warrant full-scale clinical testing. Scientific researchers and the industry welcomed the FDA action, but some agency critics said they were concerned that it could increase hazards for volunteers, or facilitate the approval of drugs before their risks are fully understood.
<< Click here to read more >>

January 11, 2006
The New York Times reports that the Senate Finance is cracking down on drug industry "educational grants" to physicians, medical associations and "patient advocacy" groups. Such payments are, in fact, kick backs for these groups' promotional services encouraging doctors to prescribe drugs off-label--a practice manufacturers are forbidden by law from doing.

The article reports that “Twenty-three drug makers spent a total of $1.47 billion in 2004 on educational grants, or an average of $64 million per company, according to the Senate Finance Committee. That number was a 20 percent increase from the total in 2003, which was $1.23 billion.”
<< Click here to read the article >>

January 9, 2006
Dr. Robert Temple, FDA Medical Policy Director of the Center for Drug Evaluation & Research dismisses the claimed findings of a flawed, but highly trumpeted recent SSRI study published in the American Journal of Psychiatry.  The study was sponsored by the National Institute of Mental Health. Dr. Temple is quoted in the FDA "Pink Sheet" stating: "The new study bears only a tangential relationship at best to the previous information…. the new study doesn't have an untreated group. They have no information at all about what would have happened to those people had they not been treated. It simply sheds no light at all on the particular point raised in the labeling or the analysis of those trials."

Unfortunately, most media swallowed the promotional hype dished out by the American Psychiatric Association (whose financial dependence on SSRI manufacturers renders its pronouncements biased and not credible). Most media did not bother to examine the actual study or to notice that the claimed findings were NOT substantiated.
<< To read the FDA’s “Pink Sheet”, click here >>

January 7, 2006
LA Times reports how drug profits infect medical studies.  First, the New England Journal of Medicine made public its concerns about crucial data having been withheld from its 2000 report on a study sponsored by Merck exaggerating the safety of its blockbuster drug Vioxx, now withdrawn. Then the news that a Johnson & Johnson subsidiary failed to include the deaths of two patients in a clinical trial of its new drug for heart failure, Natrecor, in an article published in the Journal of Emergency Medicine.
<< Click here to read more >>

January 3, 2006
A Brandeis University study reviewed clinical practice (doctor office visits) and found that drug prescriptions for the treatment of depression, anxiety and mood or attention disorders in teenagers (14 to 18) increased by 250% between 1994-2001: the rates of doctor visits that resulted in a psychotropic drug prescription increased from 3.4% in 1994-1995 to 8.3% in 2000-2001.The authors note that the greatest leap in psychotropic drug prescriptions occurred in 1999--when direct to consumer drug advertising really took off.  "We believe that direct-to-consumer advertising and other marketing strategies are key in encouraging greater use of psychotropics, particularly for the increased use found after 1999.” Advertisements for medications for ADHD, social phobia, and depression are now common in various public media. Overall spending by the pharmaceutical industry on television advertising increased sixfold to $1.5 billion dollars between 1996 and 2000, with the trend accelerating after 1997 (31). Such drug industry promotion combined with the practice of detailing to physicians may affect both the public and physician.
<< Click here to read study >>

January 2, 2006
The Tallahassee Democrat reports on a paper by Florida State University graduate student arguing that drug company ads have confused consumers by oversimplying the causes of and ways to treat depression.
<< To read article, click here >>

January 1, 2006
An editorial titled, “Psychiatry's Sick Compulsion: Turning weakness into diseases” in the Los Angeles Times by Dr. Irwin Savodnik, a psychiatrist and philosopher writes, "Unlike the rest of medicine, psychiatry diagnoses behavior that society doesn't like." 

"The erosion of personal responsibility is, arguably, the most pernicious effect of the expansive role psychiatry has come to play in American life. It has successfully replaced huge chunks of individual accountability with diagnoses, clinical histories and what turn out to be pseudoscientific explanations for deviant behavior."
<< To read, click here >>  

January 2006
An article titled, “Product Testimonials:  The problem with ‘true stories”, runs in Consumer Reports.  It reports that the problem with testimonials is that it's hard to tell which ads are true, which varnish the truth, and which are out-and-out lies. It highlights a Zoloft ad featuring Joanne M.'s story, which is "not based on actual person," according to a tiny footnote.
<< To read the article, click here >>
<< To see new Zoloft testimonials currently running, click here >>

December 29, 2005
Another Federal Court (District of New Jersey) rejects Pfizer’s preemption defense in a Zoloft suicide case (McNellis v. Pfizer). 
<< Click here to read the ruling >>

December 28, 2005
The Wall Street Journal reported that the Journal of Thoracic and Cardiovascular Surgery has taken a major step toward full disclosure of authors' conflicts of interest.

"With conflicts of interest increasingly casting doubt on the credibility of medical research, a leading surgery journal is cracking down on authors who fail to disclose links to industry, threatening to temporarily blacklist them."

The crackdown means that neither scientists found violating disclosure requirements, nor their institutions will be allowed to publish their findings in the journal. Disclosing industry connections is critical because many physicians make treatment decisions based on data published in medical journals, and need to be able to evaluate their credibility.

December 22, 2005
38 U.S. Senators with about $13.4 million in pharmaceutical stock holdings approved a sweetheart deal absolving the drug / vaccine industry from liability.  The New York Times reported that Senator Bill Frist (Majority Leader) inserted this shield from legal liability to his favorite industry "even if they are negligent or reckless."
<< Click here to read more >>

December 16, 2005
Following the abrupt resignation of Lester Crawford as chief of the FDA--after just 2 months in office--several Congress persons asked  the Office of the Inspector General to investigate the circumstances. Reuters reports the IG has subpoenaed three financial institutions after: "Financial disclosure forms filed in June 2005 show that as late as 2004, Crawford or his wife owned stock in companies with products regulated by the FDA."
<< Click here to read more >> 

December 13, 2005
Wall Street Journal reports that “ghostwritten” medical research reports – written by professional medical writers hired by PR firms under contracts to pharmaceutical companies are passed off as the work of senior academic scientists who are paid to pen their names.  Ghostwritten articles are published in major scientific journals thought to be authoritative.
<< To read more, click here >>

December 7-8, 2005
The FDA will hold a Public Hearing on the Center for Drug Evaluation and
Research's (CDER) Current Risk Communication Strategies for Human Drugs in Washington DC. The stated purpose of the hearing is to obtain public input on CDER’s current risk communication tools, identify "stakeholders" for collaboration and implementation of additional tools, and obtain greater understanding of the strengths and weaknesses of CDER's existing risk communication.

December 6, 2005
As reported in the Irish Independent, Irish doctors argue that depression “should not be seen as a disease.”  One in five people in  Ireland  was prescribed antidepressants last year- In their book, "Depression: An Emotion not a Disease," psychiatrist Dr. Michael Corry (of Clane General Hospital) and Dublin psychotherapist Dr Aine Tubridy, question the widespread use of drugs
to treat depression, saying it is more "band-aid" than cure. They recommend getting back to basics: "The authors emphasise the need to look at a range of treatments for depression - such as sleep, exercise, nutrition, acupuncture.”
<< To read more, click here >>

November 28, 2005
Fortune Magazine article titled, “Prozac Backlash” reviews the controversy surrounding Prozac and the SSRI class of antidepressants, acknowledging that “the drugs have been among the most controversial in the history of medicine. Bitter disputes about side effects have seethed for more than a decade, usually out of sight of the mainstream media--in supermarket tabloids, on websites, and in professional gatherings of scientists, regulators, and shrinks.” That battle has finally spilled into the major media-- providing the public an opportunity to judge for themselves.

Woody’s story is at the center of the article.  As Fortune reports, “her lawsuit is likely to spotlight the disturbing information that drug companies and U.S. regulators have been aware of for years – but that most doctors prescribing the drugs have known little or nothing about”.

November 28, 2005
A front page story in the New York Times sheds light on yet another unseemly pharmaceutical industry strategy for pushing brand name drugs. The industry's most effective drug marketing strategy is to hire cheerleaders as sales reps whose "educational" methods can be relied upon to sell drugs--"There's a lot of sizzle in it."  Indeed, demand for cheerleaders by the pharmaceutical industry has led one enterprising entrepreneur to form Spirited Sales Leaders.
<< Click here to read the article >>

November 25, 2005
Antidepressants are under scrutiny in a homicide case in Wisconsin. 
<< To read the article, click here >>

November 21, 2005
An article, “Bitter Pills: Antidepressants Prescribed to Millions, But Do They Work?  Worth the Risk”, runs in TIME Asia Magazine reports that skepticism is growing among "a small but growing international chorus" of professionals who, having analyzed the scientific data, have come to the conclusion that "a thorough reevaluation of current approaches to depression and further development of alternatives to drug treatment."

The dark side of the drug industry's cash cows, the antidepressants, is tumbling out of psychiatrists' closets and the profession is losing control. TIME describes the travails that a young Australian woman, who was misdiagnosed with "postnatal depression" and for three years was prescribed one after another SSRI antidepressant by her psychiatrist who kept increasing the doses as she kept getting worse.  Her cure? She secretly weaned herself off all the drugs, recovered, and watched as her psychiatrist congratulated himself on his skill "to concoct precisely the right drug regimen."  Time reports: "the honeymoon is over. Even doctors who swear by SSRIs and newer variants concede that 1-2% of patients have a severe negative reaction to these drugs. That's a small percentage. But it's a small percentage of a very large number.”
<< To read the article, click here >>  

November 16, 2005
USA Today reports, “At FDA, Graham is still the whistle blower.” On Nov. 18, 2004, Dr. David Graham, FDA's associate director for science and medicine, blew the whistle in testimony before the Senate Finance Committee, on FDA's "profound regulatory failure" to protect the public against lethal prescription drugs. One year later, Dr. Graham told USA Today:

"Today, the United States of America is worse off when it comes to drug safety than it was a year ago when I testified. That's because the FDA's recent drug safety initiatives serve only as window dressing, diverting attention away from real solutions, such as an independent Office of Drug Safety."  Among the most harmful marketed drugs are the so-called atypical antipsychotics which were approved for schizophrenia but are being prescribed primarily off-label, mostly to control behavior in children and the elderly-- despite the fact that they are linked to severe, irreversible harm, including hyperglycemia, diabetes, and death.   Dr. Graham says "FDA has known about this for two or three years." He estimates that off-label use of antipsychotics may cause up to 62,000 excess deaths a year.
<< To read the article, click here >>

November 16, 2005
Stanford University researchers reported in the December issue of Journal of Adolescent Health that their study found that the number of children 7 to 17 years old who are prescribed SSRI antidepressant drugs increased from 47% in 1995-1996 to 52% in 2001-2002, including increases in the off-label use.   “The use of psychotherapy/mental health counseling decreased. The increasingly prevalent off-label use of SSRIs, as well as possibly inappropriate use of medications in substitution of psychotherapy/mental health counseling as first-line therapy, raises concerns about physicians' adherence to evidence-based medicine."

November 15, 2005
A New York Times’ Science section article titled, “A self-Effacing Scholar is Psychiatry’s Gadfly” features a profile of Dr. David Healy.  He has worked tirelessly to bring the long concealed, unpublished evidence about the hazardous effects of SSRIs to public view.
<< To read more, click here >>  

November 14, 2005
The National Institute of Mental Health (NIMH) offers grants to researchers to study the SSRI relation to Suicidality at the same time the FDA is planning a year long study of the evidence of SSRI antidepressants and the risk of suicide in adults.

November 10, 2005
Virginia Tech hosts a public debate / discussion, “On Prozac: Debating the New Technologies of Mind”, about the controversies surrounding the largely inappropriate use of antidepressant and other mind altering drugs. 

Recently when experts who are critical of the unsubstantiated claims made about antidepressants, antipsychotics, and the other mind altering drugs that are currently widely prescribed from cradle to grave--without any evidence that the drugs improved people's lives--the psychiatry department at various universities boycotted the speakers. Robert Whitaker, author of the prize winning, seminal book, Mad in America was boycotted by Harvard Dept. of Psychiatry. Similarly, the Department of Psychiatry at Columbia University boycotted a presentation by the internationally acknowledged expert psychiatrist / psychopharmacologist, Dr. David Healy, whose research and analysis of the concealed clinical trial data, brought to public light the suicide risks of Prozac and the other SSRI antidepressants, and brought to light the utter lack of science behind the anti-depression bandwagon.

November 8, 2005
In yet another federal case (Zikis v Pfizer) involving Pfizer’s failure to warn physicians and the public about the increased risk of suicide effects for pediatric patients prescribed Zoloft, the court rejected Pfizer's argument that it didn't need to warn if the FDA did not require it to issue a warning.

Some of the key language from the Court’s order:

1) "Pfizer has yet to point to any tangible conflicts between the claims in the instant action