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EDITORIAL COMMENT: Is anyone else beginning to see a "pattern" here between the thousands of horrific canine deaths/damage due to RIMADYL and what's been occurring with thousands of deaths/damage to people from other 'PigPharma's' 'approved' drugss?  Obviously the FDA and FDA/CVM can't figure out basic "cause and effect".

It's all about profit. . . . too many pigs feeding at the trough!


Pfizer Lawsuit by Nigerians Over Drug Tests May Go Forward

February 15, 2009 - 06:04 PM
Category: FDA & Prescription Drugs

A lawsuit against Pfizer for allegedly testing a new drug without the patients’ consent may go forward, said the U.S. Court of Appeals for the Second Circuit. The divided ruling allows 88 Nigerian families to pursue their claim against the drug manufacturer under a 1789 law that gives foreigners the right to tort claims in federal courts for violations of the "law of nations."

The lawsuit claims Pfizer tested 200 Nigerian children who had contracted meningitis during a 1996 outbreak. Pfizer allegedly treated half with Ceftriaxone, an FDA-approved drug, and the other half with a new drug, Trovan. The families claim they were not informed of the nature of the experiment or the possible fatal side-effects of Trovan. They also assert that Pfizer used lower doses of Ceftriaxone in order to boost the apparent effectiveness of Trovan. The testing led to the death of 11 children and left many others blind, deaf, paralyzed or brain damaged, according to the families.

In a statement issued the day of the court’s ruling, Pfizer said it had the consent of the parents of children involved in the study, and that the study "was consistent with both international and Nigerian laws." In addition, it states that the deaths and injuries were "the direct result of the illness, and not the treatment provided to patients" in the study.

The 1789 law, also known as the Alien Tort Statute, has previously been narrowly interpreted. In upholding the lawsuit, the majority cited to the Nuremberg Code, which states that "voluntary consent of the human subject is absolutely essential" in medical experiments. The dissent, however, believed the agreements cited by the majority did not establish a private right of action against non-state actors.

If the allegations in this lawsuit are true, this behavior by a drug manufacturer is reprehensible. One wonders, if true, why Pfizer chose presumably poor African children for such "treatment". Was it because it expected no negative repercussions because these children, and their families, were too poor to protest? I hope not, but I certainly question these activities.


Drugmakers seek lawsuit immunity

BY NAN ARON and JOHN PHILO • February 20, 2009

When you use a prescription drug or medical device, you assume that if it causes you serious harm its maker will be held accountable -- right? Wrong. Not in Michigan today, and soon not in any other state if the drug industry has its way.


Since 1995, Michigan has been the only state that prohibits victims of unsafe drugs from going before a jury to seek compensation. The state law protecting manufacturers was passed in 1995 with strong support from Upjohn, now part of Pfizer, the largest drug company in the world.

Now Wyeth Pharmaceuticals, which is also merging with Pfizer, has a case before the U.S. Supreme Court. A decision in Wyeth's favor would take away the right of Americans in every state to be compensated when products that are supposed to promote health instead hurt patients.

The drug giant argues that once a company has permission from the U.S. Food and Drug Administration to market a medication or a device such as a defibrillator, heart pump or artificial heart valve, hip or knee, it can no longer be held accountable in state court for any harm that product causes.

This "hit and run" legal theory is like saying that once someone gets a driver's license, that person can't be held legally responsible for ramming your car on the freeway and sending you to the hospital.

The test case before the U.S. Supreme Court involves a professional musician named Diana Levine. Levine went to the emergency room for a severe migraine headache. One of the drugs administered there caused gangrene and then amputation of her arm.

Wyeth, which made and marketed the drug, knew there was significant risk of gangrene when the medicine was administered by an intravenous push injection. The risk had already been demonstrated in at least 20 cases. When Levine sought compensation for her injuries, a jury, and then her state's Supreme Court, found that Wyeth should be held accountable for its failure to warn doctors of this risk.

If the drug giant is able to convince the U.S. Supreme Court to overturn the jury verdict and the state court, manufacturers of medications and medical devices will be allowed to hit and run throughout the country. And they will lose an important incentive to make sure their products are safe in the first place.

Rather than replicating Michigan's anti-consumer policy nationwide, we need a Supreme Court ruling that will allow our legislators to repeal the state's hit-and-run law. Past experience has proved that FDA permission to market a product does not guarantee public safety. Well known drugs permitted by the FDA but later found to have caused serious health damage include Vioxx, Zoloft, fen-phen, Avandia and Celebrex.

Even if the Supreme Court rules in favor of the drug industry, there are other remedies. Congress can pass a law making it crystal clear that federal regulators' approval to market a product does not relieve manufacturers of responsibility to make the product safe.

In addition, Michigan's U.S. senators, Carl Levin and Debbie Stabenow, will have the opportunity to support appointments by President Barack Obama of federal judges at all levels who recognize that our Constitution provides for equal justice for all, not just for big companies or CEOs.

Drug companies spend millions of dollars a year lobbying Congress. The rest of us must be heard before it's too late.

NAN ARON is president of Alliance for Justice, a coalition of more than 80 public interest organizations. Write her at JOHN PHILO is legal director of the Sugar Law Center, a national nonprofit public interest law center based in Detroit. Write to him at You may also write to them in care of the Free Press Editorial Page, 615 W. Lafayette, Detroit, MI 48226.


Kansas teen wants Gardasil taken off the market

08:55 PM CST on Sunday, February 15, 2009


It was a hot issue here in Texas a couple of years ago.  Now Gardasil, the vaccine against the virus that causes cervical caner, is back in the spotlight.

Gabi Swank, a 16-year-old from Wichita, Kansas, says she and other girls are dying from the side-effects of the drug.  Once a cheerleader with a 4.0 grade point average, she is now homebound, suffering from seizures, migraines and even two small strokes.

Swank’s doctors diagnosed her with cerebral vasculatis, a terminal disease.  And he blames Gardasil complications.

Now, Swank and her mother are on a mission.

“She looked at me with the most somber face and she said, ‘If I have to die to save other girls, then I am prepared to do that’,” said Gabi’s mother, Shannon Schrag.

“I want this drug off the market,” said Gabi.

Governor Rick Perry made headlines two years ago when he made Texas the first state to require the vaccine against human pappilomavirus (HPV), a sexually transmitted disease.  Conservatives and parents rights groups felt the requirement condoned pre-marital sex.

The makers of Gardasil say the drug is safe.  They’re hoping to vaccinate boys as well.


The Tragic Truth behind the Gardasil Nightmare

Friday, February 13, 2009 by: Herb Newborg, citizen journalist
(NaturalNews) Why have the pharmaceutical and biotechnology industries chosen to experiment with the first ever, large scale application of a new, unproven, genetically modified, inter-species gene mixing vaccine technology on the female youth of an entire generation?

Under the ruse of attempting to eradicate cervical cancer, Merck is actually engaged in the first large scale, real world deployment and testing of genetically modified DNA, genetically engineered proteins and genetics produced by the combining of genetic material from more than one origin or species in a vaccine.

The wide spread promotion and attempts to mandate the use of this drug in the United States is clearly not predicated on preventing deaths from cervical cancer as the drug has only been approved in the U.S. for use in girls 9-26, ages when deaths from cervical cancer happen rarely, if ever. Cervical cancer has been steadily decreasing in the U.S. since 1955.

The American Cancer Society states:

"Cervical cancer was once one of the most common causes of cancer death for American women. The cervical cancer death rate declined by 74% between 1955 and 1992. The main reason for this change is the increased use of the Pap test. This screening procedure can find changes in the cervix before cancer develops. It can also find early cervical cancer in its most curable stage. The death rate from cervical cancer continues to decline by nearly 4% a year. Cervical cancer tends to occur in midlife. Most cases are found in women younger than 50. It rarely develops in women younger than 20. Almost 20 percent of women are diagnosed with cervical cancer when they are over 65."

According to a 2001 presentation by Elizabeth R. Unger Ph.D., M.D., then Acting Chief, Papillomavirus Section of the U.S. Centers for Disease Control and Prevention (CDCP):
*HPV infection is very prevalent in the population
*OVERALL 75% of population exposed
*Genital HPV is acquired around the time of sexual debut
*Consistent epidemiologic association of HPV with cervical cancer precursor lesions
*Plausible biologic mechanisms for HPV oncogenesis (cells becoming cancerous)
*HPV oncogenesis is a rare event with long interval between infection and cancer
*Infection alone is insufficient to cause cancer
*Additional factors required for neoplasia (abnormal proliferation of cells)

Paraphrasing, more than 75% of the population is exposed to HPV. HPV exposure typically occurs when a woman becomes sexually active. There is an association between HPV and cervical cancer. HPV causing cervical cancer is plausible, yet it alone does not cause cervical cancer. Cervical cancer is a rare event and there is a "long interval" between infection and development of cervical cancer.

Now follow closely. Cervical cancer typically develops in mid life (around 48 years old) even though HPV exposure typically occurs at sexual debut. This new vaccine is purported to protect against a disease that occurs, if ever, 20 to 35 years after HPV infection. Yet the duration of protection from the vaccine is unknown.

According to the FDA Gardasil approval announcement: "For most women, the body`s own defense system will clear the virus and infected women do not develop related health problems. However, some HPV types can cause abnormal cells on the lining of the cervix that years later (emphasis added) can turn into cancer."

The clinical trials on this vaccine only lasted 5 years. It is chronologically impossible to have determined efficacy in preventing cervical cancer as a result of administration of this vaccine in the study population. Speculation as to whether the protection against HPV offered by this vaccine lasts beyond the five years of studies conducted to date is just that, speculation.

By the FDA`s own statement: "For most women, the body`s own defense system will clear the virus". Combined with the frequent Pap tests of study participants who were participating in a study of sexually transmitted disease, it is fair to say that the 20,541 sixteen to twenty-six year old participants in the clinical trials were far from a random representation of the average female`s risk for contracting HPV or developing cervical cancer.

The studies on nine to fifteen year old girls included far fewer participants and were halted prior to completion.

Speculation as to whether or not girls vaccinated with Gardasil will experience a lower rate of cervical cancer 10 to 30 years from now is also merely conjecture. As such, there is currently no official schedule on required booster doses of the drug.

In the FDA`s approval announcement, they state: "While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers."

Believed highly likely?

Is the role of the FDA to ensure that a drug has been proven to be a safe and effective or have we reduced the burden down to "likely to convey some benefit, maybe, sometime down the road"?

In addition, according to the FDA announcement of Gardasil`s approval , somehow the association and plausible mechanism between HPV and cervical cancer with the crystal clear statement that HPV "infection alone is insufficient to cause cancer" stated in the 2001 CDCP presentation magically morphed into "HPV is the cause of 70% of all cervical cancer".

Promoting a new, unproven, vaccine to an entire generation of young girls as a cancer vaccine, without adequate long-term safety or efficacy testing is unethical and in this author`s opinion immoral.

But wait, there is much more.

This is a whole new type of vaccine called a virus-like particle (VLP) vaccine. Anti-viral vaccines have traditionally been prepared by using attenuated, or weakened, forms of the infectious virus. This type of vaccine involves complications in manufacturing.

These brand new virus-like particle (VLP) based vaccines including Merck`s Gardasil and GSK`s Cervarix are the first ever FDA approved VLP vaccines. No long term studies or studies on populations larger than the Gardasil clinical trial (20,541 women for up to 5 years) have ever been conducted on VLP technology or the specific inter-species genetic mixing this technology represents.
According to National Institute of Health (NIH) documents:

"The underlying technology for the vaccine originated in the laboratories of Drs. John Schiller and Douglas Lowy of the NIH National Cancer Institute. Drs. Schiller and Lowy commenced their research on the molecular biology of HPV nearly 20 years ago. Among their numerous findings, they discovered that the major outer coat protein of the HPV virus, called L1, could self assemble into non-infectious virus-like particles (VLPs) that closely resemble the native outer shell of the actual virus.

The principle behind the vaccine is that exposure to VLPs triggers the immune system to produce protective antibodies. If an individual is exposed to HPV after receiving the vaccine, the immune system already contains the antibodies necessary to prevent virus infection. The antibodies primarily function by preventing the virus from binding to the cell which is necessary in order for the virus to reproduce and thrive.

The catch is that for induction of HPV neutralizing antibodies the L1 must be in the same conformation as in the intact virus. Unlike some other viral vaccines, inactivated virus produced in cultured cells was not a viable option because the viruses could not be produced in sufficient quantities in vitro. Also, the inactivated virions would still contain the viral oncogenes, which would preclude use in healthy young people, the primary target population. (In other words, the vaccine would produce cancer, not prevent it.)

Schiller and Lowy demonstrated that large quantities of VLPs could be produced in insect cells (emphasis added) infected with L1 recombinant baculovirus (a genetically engineered protein grown in insect larvae). Critically, they also showed in animal models that the L1 VLPs were able to induce high titers of neutralizing antibodies, comparable to those induced by authentic virions. Furthermore, they and their colleagues demonstrated that L1 VLP vaccination could protect animals from experimental challenge with high dose virus of the corresponding animal papillomavirus (emphasis added) types and that human and animal papillomavirus (emphasis again added) L1 behaved similarly in the ability to assemble into VLP."

While individual papilloma virus types tend to be highly adapted to replication in a single animal species, researchers have already identified inter-species transmission of papilloma virus in rabbits and cattle. The evolution of papilloma viruses is slow compared to many other virus types. It is believed that papilloma viruses generally co-evolve with a particular species of host over many years.

The long term results of introducing into the human body genetically engineered, recombinant human, insect and animal DNA, along with human and animal strains of papillomavirus are unknown, untested and unproven, particularly when used as a vaccine, which effectively bypasses all of the body`s natural defenses against outside pathogens (skin, saliva, mucous, etc.)

The current deaths and maiming of young girls used as guinea pigs to test this new technology may be just the beginning. No one can predict what adverse consequences this newest inter-species gene mixing technology may cause. Remember we are dealing with the reproductive systems of an entire generation of young woman.

Furthermore, the two strains of HPV which the vaccine purportedly protects against account for only 70% of all cervical cancers, leaving at least 30% of these young girls with no protection against cervical cancer. To call this a cervical cancer vaccine is a tragic deception.

In addition, many health care experts have publicly predicted that cervical cancer deaths will increase sharply, with routine Pap tests foregone under a false sense of security that Gardasil has made them immune to cervical cancer (and not just the two strains of alleged cancer causing HPV for which the vaccine claims efficacy).

The fact that the vaccine is not effective in girls already exposed to the virus, yet parental supervision is mandated during the interview to determine if the recipient is sexually active, further undermines the ability to discern "qualified" candidates for this potentially dangerous, new, experimental, unproven, falsely promoted vaccine technology. Imagine a 16 year old girl who does not want to confess that she has been sexually active to a parent stating that she has not and then being administered this drug. According to a reported Merck document, if this young girl has previously been infected with HPV, she has just increased her risk of developing high grade pre-cancerous lesions of the cervix by 44.6%.

It was reported to the FDA as early as October 30, 2006 by letter. Sin Hang Lee, M.D., a practicing pathologist wrote to Dr. Steven I. Gutman, Director, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), Center for Devices and Radiological Health (CDRH), FDA, enclosing the manuscript of a scientific report titled "Human Papillomavirus Genotyping by DNA Sequencing-The Gold Standard HPV Test for Patient Care," which was submitted to a professional journal to be considered for publication. The purpose of the letter was to inform the FDA that a more sensitive and more specific device is being introduced for detection of HPV in clinical samples and for preparation of materials for HPV genotyping and to request advice and guidance from the agency for making this device available to hospital laboratories at the point of care . With this letter and manuscript, the FDA was informed of the need for a new generation of HPV testing based on new information available because:

1) A sensitive HPV detection device that can provide accurate genotyping information is needed for following patients with persistent infection that is now recognized to be the tumor promoter in cancer induction.

2) A PCR-based HPV detection device with provision for accurate HPV genotyping is more urgently needed now because vaccination with Gardasil of the women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV has been found to increase the risk of developing high-grade precancerous lesions by 44.6%, according to an FDA VRBPAC Background Document: Gardasil HPV Quadrivalent Vaccine . May 18, 2006 VRBPAC Meeting.
www.fda.izov/ohrms/dockets/ac/06/br... [14].

Page 10 of the attached document included this statement:

The introduction of the type-specific Gardasil HPV vaccines among the sexually active women also requires genotype monitoring of the HPV infections before and after immunization to develop prevention strategy for the individual patients. Based on a `Background Document" submitted to the FDA by Merck & Co., Inc., injection of HPV vaccines into women who have concurrent vaccine-relevant HPV type infections may increase the risk, by 44 .6%, of developing high-grade precancerous lesions in the cervix. Therefore, it would be prudent to perform a sensitive HPV detection assay with accurate genotype determination on the patients to be vaccinated if prior HPV infection is suspected.

Recombinant DNA, genetically engineered proteins, inter-species gene mixing, questionable new vaccine technology, lack of long term safety and efficacy data, questionable pre-qualifications procedures and now, an extremely high prevalence of reported adverse side effects up to and including miscarriage and death.

This vaccine represents more than just bottom line profit for Merck. This is the first genetically modified drug unleashed across a broad swath of unsuspecting, formerly healthy Americans.

Unfortunately, the target they chose for this grand genetic experiment is the entire female population of mothers to be for all future generations. Can we really afford to allow this fraud and deception to continue?

Sunday, February 06, 2005 Commentary
original article online: Fri Jan 21, 2005 06:43 PM ET
from: at:

Vioxx and Celebrex were widely overprescribed to people who did not need these drugs

Merck & Co. Inc's Vioxx was recalled in September because a study linked the drug to increased risk of heart attacks and strokes, while Pfizer's Celebrex is under a cloud after data showing a similar heightened risk.

The study by doctors at Stanford University and the University of Chicago found the two COX-2 inhibitors were taken by millions of people who were not at risk of gastrointestinal bleeding, the main reason patients were told to switch from aspirin and other lower-cost painkillers.

COX-2 inhibitors cost 10 to 15 times as much as the drugs they replaced, the study published in the Archives of Internal Medicine said.

"We found a rapid, nationwide shift away from older, inexpensive drugs with better established safety and efficacy to newer, costly drugs with no real history," said study author G. Caleb Alexander, a medical ethicist at the University of Chicago.

Within a year of being introduced in 1999, Vioxx and Celebrex were being heavily promoted as "super-aspirin" and bringing in billions of dollars in revenue annually, the study said. Merck spent $161 million in 2000 on direct-to-consumer marketing of Vioxx, it said.

Using data from the National Center for Health Statistics, the study concluded that 73 percent of patients considered at low or very low risk of gastrointestinal problems should not have been considered for the newer drugs. Gastrointestinal bleeding usually affects only at-risk patients who must take aspirin and other non-steroidal anti-inflammatory drugs, or NSAIDs, for long periods, it said.

By 2002, 17.6 million patients at low risk of gastrointestinal bleeding, or 66 percent of those patients, were taking one of the two COX-2 inhibitors, the study said.

The drugs were also taken by millions of people who should not have been, including 16 million people suffering from congestive heart failure, or liver or kidney dysfunction. These patients might also have been hurt by NSAIDs, it said.

"The findings demonstrate the challenge of limiting innovative therapies to the settings in which they are initially targeted and maximally cost-effective," Alexander wrote.

The U.S. Food and Drug Administration is convening a panel next month to examine the COX-2 inhibitors, including Pfizer's new entry Bextra, which has also been found to raise the risk of heart attack in people who have had heart bypass surgery.

Spokesmen for Pfizer and Merck could not immediately comment.

© Reuters 2005. All Rights Reserved.

Wednesday, February 02, 2005 Commentary
Merck now under criminal investigation by the Justice Department for Vioxx scandal
Pharmaceutical giant Merck is now under scrutiny by the Justice Department, which has begun a criminal investigation into the firm’s marketing of the painkiller Vioxx (withdrawn from the market on September 30, 2004). Since that time, the Vioxx scandal has expanded thanks in part to the publication of internal Merck e-mails by the Wall Street Journal. These e-mails showed that Merck was apparently aware of the dangers of Vioxx several years ago and yet attempted to construct clinical studies to obscure those dangers in an effort to continue marketing these drugs to the general public.


In a report filed by FDA researcher David Graham on November 2nd, it was revealed that Vioxx may have contributed to almost 28,000 heart attacks and deaths over the past five years. In response to all of this, the FDA has humorously announced that it's going to investigate itself and find out if it did anything wrong. It also said it will stop censoring its own scientists.

These statements, coming from an agency that seems sworn to protect the profits of the pharmaceutical industry, seem laughable. No one who is familiar with the facts surrounding this case and the ongoing behavior of the FDA is going to be fooled by such promises. What this is showing is the grand failure of the FDA and the whole system of drug approval and post-approval safety. It's showing that we as a nation are literally killing our own citizens with toxic chemicals that are approved by a corrupt agency that approves drugs based on distorted clinical trials and the suppression of negative evidence or information, including suppressing the free speech of scientists, researchers and outspoken physicians who are trying to warn people about the dangers of these drugs.


But now, suddenly, it's quite clear to nearly everyone that we are witnessing a racket. This is being operated almost exactly like a criminal organization for which laws like the RICO Act were originally designed. This is a modern version of Al Capone, except instead of carrying pistols, his gang is carrying prescription drugs and rubber stamps that say "FDA approved."

[see site for full article and links]


Wednesday, January 26, 2005 Commentary

FDA delays new rules to protect public from mad cow disease; beef industry couldn't be happier

The FDA almost never takes action to protect the public. Instead, the agency's decisions consistently and almost universally protect the financial interests of influential corporations such as pharmaceutical companies or, in this case, beef industry companies.

Mad cow disease is real, and it's here in America. It's caused by insane feeding practices that allow cattle ranchers to feed their cows chicken litter (yes, chicken dung) and the blood, brains and spinal cord tissue from other cows and dead animals. This is the stuff that goes into the food you're eating, folks (if you eat red meat, that is).

The sane thing would be to ban the use of these feed items for cows. That's what the FDA should have done six months ago. But now, they're delaying it even further: it could take two years to get a decision from the FDA on this. Meanwhile, cattle ranchers keep on feeding their cows practically any form of protein they can get their hands on, regardless of its safety.

In this situation, both the FDA and the USDA are acting out of total disregard for the health and safety of the public. The beef industry loves all the delays, because they've never wanted to be forced to actually follow sane feeding practices in the first place (it would add cost to the beef). They'd rather just keep on feeding their cows anything they can find -- blood, brain matter, spinal cords, chicken dung, you name it -- and pretend mad cow disease doesn't exist.

As a consumer, if you thought the FDA was protecting you, you're sadly mistaken. The agency acts more like a marketing branch for private industry than a government regulator.


Which Pill for the Drug Industry?
At an ethics confab, participants shared many ideas but reached little consensus on how to revive sliding public confidence in the sector

Following a controversy-filled 2004, the medical community starts the new year faced with a daunting challenge -- how to restore public trust in drugs, the companies that make them, and the regulatory system that governs the producers. The current thinking is that more information is the cure. By disclosing how drugs are tested, debacles can potentially be prevented, and trust reestablished.
Perhaps. But just how that task will be accomplished seems to stir up more questions than answers. That was clear during an influential policy summit Jan. 10-11 organized by Fordham University's Center for Ethics Education. Representatives from academia, medical journals, the drug industry, patient advocacy groups, hospitals, lawyers, and government agencies gathered to discuss ways to strike the proper balance between the industry's financial interests and public safety.

"DEFENSIVE POSITION."  Lately, high-profile problems have been hitting drugmakers right and left. For one, a recent report documented an increased risk of cardiovascular problems in users of popular arthritis pain medication featuring Cox-2 inhibitors. Following the report's release , Merck (
MRK ) decided on Sept. 30 to pull Vioxx from the market -- too late, critics said. Pfizer (PFE ) chose to keep selling its own arthritis treatments, Celebrex and Bextra.

But both companies saw their stocks plunge as the potential for expensive lawsuits escalated. Further confusing consumers, even the relative risk-to-benefit ratio of common painkillers such as Aleve has been called in question.

"We're all here because of the problems and scandals we've had," says Greg Koski, senior scientist at the Institute for Health Policy at Massachusetts General Hospital. "We're in a defensive position."

SENTIMENT SHIFT.  The meeting, held near New York's Lincoln Center on the Fordham campus, saw plenty of spirited discussion. Representatives from drugmakers contend that the primary solution proposed -- releasing the details of early-stage trials -- would be of limited benefit to the public while also harming companies' ability to compete. Other participants predicted logistical and financial nightmares in managing all the information. Aside from the certainty that changes are afoot, a consensus on how to build a more transparent system seemed distant.
Public sentiment about drug regulation has shifted dramatically over the last decade. Theresa Toigo, director of the office of special health issues at the Food & Drug Administration, notes that in the late 1980s, when the U.S. HIV/AIDS epidemic was peaking, patient groups accused the agency of being too slow to approve new drugs. Cancer-patient advocacy groups have made similar criticisms.

Lately, the discourse has shifted in the opposite direction. Many argue that regulators are approving drugs too hastily. Some claim that the FDA has been co-opted by industry, since Congress created a fee-based system to encourage more expeditious drug approvals in 1992. In any case, "even the perception of conflict of interest must be addressed," says Toigo.

ELUSIVE RESULTS.  The popular solution for the system's woes are registries that would list information about clinical trials being undertaken by industry and academia. If all parties signed on, registries would provide a record of what studies were begun and when. In theory, that would keep pharmaceutical players from sweeping studies with poor results under the rug.

Consequently, an onslaught of registries of various kinds is coming. Drug industry trade group PhRMA announced plans for a voluntary registry of trials in September. Prominent medical journals, including the prestigious New England Journal of Medicine, have in recent months set policies requiring studies submitted for publication to be registered from their inception. And some drugmakers are setting up their own registries.

Full-fledged databases containing trial results would be the ideal solution, but that would be significantly harder to pull off, given companies' and researchers' wariness about revealing intellectual property. Still, plaintiffs' lawyer Alan Milstein, of Sherman, Silverstein, Kohl, Rose & Poldolsky, argues that such a database might have saved Jesse Gelsinger, the 18-year-old who died in 1999 while participating in an experimental gene therapy study at the University of Pennsylvania. "Results of previous experiments could have been known," says Milstein, and those studies might have affected Gelsinger's decision to participate in the study. The Pennsauken (N.J.)-based lawyer represented Gelsinger's family.

REVEALING "ADVERSE EVENTS."  However, disclosure of research findings, whether by individual researchers or giant businesses, has always been a touchy subject. "All of this gets into the broader issues of how we as scientists share information and increase knowledge," says John Schneider, chairman-elect of the council of scientific affairs at the American Medical Assn. Schneider supports a registry that, at minimum, would include information on what type of studies are under way and who is conducting them. The AMA suggest that trials have specific numeric identifiers.

Improvements to the process of tracking side effects that turn up after a drug is on the market are also overdue. Drugmakers tend to keep negative trial data to themselves -- as shown again by the recent Washington Post revelations that companies conducted studies of antidepressants in kids but did not publish the results, which showed an increased suicide risk among teens taking such medication.

"Dealing with adverse events is a high priority," says Bernard Schwetz, director of the Office of Human Research Protections, a division within the U.S. Health & Human Services Dept. "Not enough has been done about it."

INTERPRETER WANTED.  The value of all this information also depends on how accessible it is. Many fear that such registries and databases will be undecipherable morasses. "We can have all the data in the world, but someone needs to analyze it," says Larry Hirsch, executive director of medical communications at Merck Research Laboratories.

The job of interpreting data is already taken, in large part, by the FDA. A third-party interpreter or curator of the data, however, would be useful in helping the public make sense of it, says Robert Rubin, professor of medicine at Harvard Medical School.

Trying to set up such a system in a period of crisis isn't optimal timing. But the researchers, regulators, and industry players know they can't afford to let public confidence continue its slide.
COMMENT:  It has apparently NOT occurred to the various and assorted "experts" that the problems have been a direct result of all the lying, denying and covering up the risks and dangers of their respective products in their mad scramble to make money no matter how many pets and people DIE or are damaged.  It is my own opinion that the 'solution' to the drug industry/health provider problems is to just STOP all the lying, denying and covering up and to begin to EARN the 'public confidence' by simply telling the TRUTH - ALL OF IT!  Perhaps 'the pill' for these folks is for them to be taking 'truth serum' [sodium pentathol] and/or lie-detector tests [polygraphs] BEFORE  getting FDA approval for marketing.  Ginger Sanchez

Unfortunately, the 'rot' starts at the top:

Drug Control Office Faulted For Issuing Fake News Tapes

By Ceci Connolly
Washington Post Staff Writer
Friday, January 7, 2005; Page A17

Shortly before last year's Super Bowl, local news stations across the country aired a story by Mike Morris describing plans for a new White House ad campaign on the dangers of drug abuse.

What viewers did not know was that Morris is not a journalist and his "report" was produced by the government, actions that constituted illegal "covert propaganda," according to an investigation by the Government Accountability Office.

In the second ruling of its kind, the investigative arm of Congress this week scolded the Bush administration for distributing phony prepackaged news reports that include a "suggested live intro" for anchors to read, interviews with Washington officials and a closing that mimics a typical broadcast news sign off.

Although television stations knew the materials were produced by the Office of National Drug Control Policy, there was nothing in the two-minute, prepackaged reports that would indicate to viewers that they came from the government or that Morris, a former journalist, was working under contract for the government.

"You think you are getting a news story, but what you are getting is a paid announcement," said Susan A. Poling, managing associate general counsel at the GAO. "What is objectionable about these is the fact the viewer has no idea their tax dollars are being used to write and produce this video segment."

In May, the GAO concluded that the Department of Health and Human Services violated two federal laws with similar fake news reports touting the administration's new Medicare drug benefit. When that opinion was released, officials at the drug control office decided to stop the practice, spokesman Thomas A. Riley said.

"Our lawyers disagree with the GAO interpretation," he said. Nevertheless, if the video releases were going to be "controversial or create an appearance of a problem," the agency decided it was not worth pursuing, he said.

The prepackaged news pieces represent a fraction of the anti-drug messages distributed by the office, Riley said. Production and distribution of the video news releases cost about $155,000.

Riley said broadcast stations were fully aware they were receiving materials akin to printed news releases that producers could "slice and dice it however they want."

In one video, titled "Urging Parents to Get the Facts Straight on Teen Marijuana Use," news stations were provided a script for the news anchor. It reads: "Despite the fact that marijuana is the most widely used illicit drug among today's youth, many parents admit they're still not taking the drug seriously. Now, the nation's experts in health, education and safety have joined the Drug Czar to speak directly to parents about the very real risks of teen marijuana use. Mike Morris has more."

After interview snippets with John Walters, who heads the drug control policy office, and other experts, the story closes with the voiceover: "This is Mike Morris reporting."

In another, the announcer appears to be "reporting" on a news conference by drug control officials, when "in reality, they are just paid to say a script," Poling said. "In essence, they're actors."

The drug control agency distributed at least seven prepackaged news reports to 770 TV stations. At least 300 news shows used some portion of the materials, though it was impossible to determine how many aired the full prepackaged story or just portions such as "sound bites," Riley said.

If the videos had been identified as coming from the federal agency, that would have been legal, Poling said. But the television package looks like authentic independent journalism.

"The critical element of covert propaganda is the concealment of the agency's role in sponsoring the materials," GAO wrote to Rep. Henry A. Waxman (D-Calif.), who requested the Jan. 4 report.

"It is illegal to use taxpayer dollars to influence public opinion surreptitiously," Waxman said yesterday. "Unfortunately, this is the second time in less than a year that GAO has caught the Bush administration violating a fundamental principle of open government."

Saturday, January 08, 2005 commentary:

American Medical Association calls for wholesale reforms of the FDA

There's a major development unfolding in the world of conventional medicine. As you know, I've been calling for major reform of the FDA for several years. Other pioneering doctors and natural health physicians have been voicing such calls for decades. But recently, the journal of the American Medical Association joined us in calling for comprehensive, radical reforms of the FDA. This is unprecedented in the world of modern medicine.

In these calls for reform, which were published in a strongly worded editorial in JAMA, the AMA says, "It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong." In other words, the Journal of the American Medical Association is saying that we can't trust the FDA to investigate itself. Clearly, the FDA's credibility is all but destroyed after revelations that the agency helped cover up the dangers of prescription drugs like Vioxx, which ultimately have led to the injury and even death of potentially hundreds of thousands of Americans.

The agency has quite clearly sought to protect the profits of drug companies at the expense of public health. It has ignored its own drug safety scientists such as chief drug safety researcher Dr. David Graham, who was silenced by the FDA for years as he attempted to warn the public about the dangers of Vioxx, Bextra and other drugs. The FDA clearly cannot be trusted to protect the American public. In fact, I believe the FDA's actions to this date are criminal in nature, and that the Justice Department should initiate an investigation to hold key FDA decision makers criminally responsible for the untold death and suffering they have unleashed upon the American public.

The American Medical Association hasn't gone that far, but they do state that the trust in the FDA has been all but destroyed and that it is impossible for the FDA to investigate itself. The FDA, for its part, denies that it has done anything wrong, and this indeed is part of the problem. It cannot see its own bias; it's in pure defense mode, rejecting all criticisms, claiming that it is the "gold standard" of drug safety around the world. The FDA even claims that Vioxx was handled in an ethical, responsible manner and that the agency did everything in its power to protect the public. These statements are beyond ridiculous. They represent such distortions in the mind of the FDA defenders that they can only be called psychotic in nature. It seems quite clear that these defenders of the FDA are suffering from rather serious mental disorders on their own. Perhaps they need to be on antidepressant drugs.

Aside from all of this, the FDA also has a rather lengthy history of suppressing alternative medicines such as herbal medicine, nutritional supplements, vitamins, homeopathy and other modalities that are not under the control of the pharmaceutical industry. This is something that has not received much public attention, but which may receive attention in the years ahead as the true criminal behavior of the FDA begins to unravel and be made public.

It is quite accurate to describe the behavior of the FDA and the pharmaceutical companies as that of a criminal racket similar to Big Tobacco in its efforts to market a dangerous product to all Americans including young children. The FDA, in conjunction with the pharmaceutical industry, has been and continues to be engaged in the systematic suppression and discrediting of alternative medical supplements and products that are well proven to prevent chronic disease and even treat those diseases in a much safer manner than prescription drugs. In my view, the most serious crimes of the FDA are not its handling of Vioxx, nor its censorship of its own scientists... the real crimes are much larger and still not being discussed publicly. The crimes are the systematic suppression of alternative therapies and the exploitation of the health of the American public for corporate profit. It's worse than Big Tobacco. It's worse than Enron. Because in this case we're talking about the lives of literally millions of people.

Of course, not everybody in the medical community agrees that the FDA is engaged in criminal behavior. But certainly more and more are now convinced that the FDA has lost its credibility and can no longer be trusted to monitor the safety status of prescription drugs. Make no mistake: there are certainly people within the FDA who are credible, well-informed drug safety scientists who could do a fantastic job of protecting the health of the American public.

Unfortunately, those people don't call the shots at the agency. Right now, the FDA is run by power-hungry bureaucrats who silence the drug safety scientists that should be running the show!

So what are the alternatives to today's FDA? As the American Medical Association editorial suggests, it is time for us to start a new department. A department to oversee the FDA. This is precisely what I suggested many months ago when I promoted the idea of a Department of Internal Affairs at the FDA. This would be similar to IA offices in local police departments that are charged with investigating police corruption and making sure that those who enforce the law are not themselves breaking the law. Clearly, we need some kind of Department of Internal Affairs at the FDA today. And the first job of such a department should be, I believe, to investigate the behavior of FDA officials and press for criminal charges against those responsible for the actions on prescription drugs that have harmed and killed American citizens. It is only with the threat of criminal prosecution that the remaining FDA employees will come to their senses and start doing the jobs they were supposed to do in the first place, which is to regulate the pharmaceutical industry, not protect it and promote it.

At the same time, it is important that this new Department of Internal Affairs, or whatever it ends up being called, is staffed with people who do not have financial ties to the pharmaceutical companies themselves. Because that's the problem with the FDA today. The vast majority of decision makers at the FDA either have worked for drug companies in the past or are likely to work for drug companies in the future. Furthermore, it should be illegal for any person who works at the FDA to own stock of drug companies or to be on the payroll of drug companies, because if these people are being funded by drug companies then obviously it is in their financial interest to make sure that drug companies succeed financially. It is an obvious and potentially deadly conflict of interest that must be immediately rooted out and eliminated.

[below: This is part two of an article on FDA reform.]

Saturday, January 08, 2005 commentary:

Direct-to-consumer advertising must be banned as part of FDA reform

The next thing that should be done in reforming the FDA is to reverse some of the dangerous and poorly made decisions put in place by the FDA over the last few years. The most obvious of these is the legalization of direct-to-consumer advertising by drug companies. This decision was made in 1997 and it allowed drug companies to place ads on television, in magazines, newspapers, billboards and other media with the purported goal of "educating" consumers about prescription drugs. And yet the very premise is laughable. No reasonable person could possibly believe that drug companies should advertising prescription drugs to patients who don't have medical qualifications to even understand if they should use those drugs in the first place. The idea of pushing these drugs to patients so that they go to their doctors and request them by name is medically reckless. It has no medical basis whatsoever. It is clearly just a ploy that was approved by the FDA to financially benefit the drug companies at the expense of public health.

It is this direct-to-consumer advertising, in fact, that is largely responsible for the over-medication of people with dangerous drugs such as Vioxx. This direct-to-consumer advertising continues today, and it is adding to the problem by creating an over-medicated nation where patients think they have to make a list of advertised drugs, then go to their doctor and request them by name. Many times, patients don't even have any idea what these drugs do -- they just see these images of happy, healthy people on television who have been hired to play roles in these drug advertisements, and the patients of course think they want to feel that way too, so they go to their doctor and request these drugs.

The whole system is absurd. First of all, people who take prescription drugs aren't healthier in the long run anyway. The more drugs you take, the worse you get, because every drug has unsafe side effects as recently admitted by the FDA. Every drug you take makes you less healthy in the long run. There is no prescription drug that is as good for you as changing your lifestyle, engaging in physical exercise, and making healthier food choices to prevent chronic disease. Prescription drugs have absolutely no place as lifelong chemicals to be consumed by human beings. At best, they should only be used for short term acute disorders as stop-gap measures to help people survive while they make lifestyle changes that eliminate the underlying cause of their health problems in the first place.

The next thing that should be addressed at the FDA is the dissolution of the financial arrangements between pharmaceutical companies and the FDA. Today, pharmaceutical companies actually pay the FDA to review their drugs. This turns drug companies into customers, and the more customers the FDA pleases, the more money the agency earns, meaning it can grow its own staff and expand its power base. So of course it's going to be in the long term interests of key FDA decision makers to please its customers. Those customers are the drug companies.

This financial relationship must end. The FDA should be funded solely by taxpayer dollars, not by drug companies themselves. This would allow the FDA the neutrality and the independent viewpoint from which it could make an honest safety assessment of prescription drugs.

One more thing that needs to be addressed is the drug side effects reporting mechanism, because today there is absolutely no requirement whatsoever for doctors to report toxic side effects from prescription drugs to the FDA. In fact, there is not even a requirement for drug companies to report their information to the FDA when they learn about toxic side effects in drugs. The reporting system is 100% voluntary. And that means it's nearly a miracle when any drug accumulates enough negative information to actually be banned by the FDA, because enough people have to volunteer that information, and it has to accumulate over time to the point where the FDA can no longer ignore it. This is a poor system for protecting the public health. The reporting of side effects from prescription drugs should be mandatory. This is common sense, and drug companies should be held criminally responsible if they fail to reveal evidence they have about the negative effects of prescription drugs.

So in effect, to look at this whole situation, we have one big problem, and that's the FDA as it exists today. It is broken. It is discredited. It is operated by ethically disadvantaged individuals who deserve to be prosecuted for not just endangering, but actually killing literally hundreds of thousands of American citizens. That is not an exaggeration of the statistics. But even if we create an alternative to the FDA, we still have three big problems that need to be addressed right away.

The first is direct-to-consumer advertising. The second is the funding of the FDA. And the third is the drug side effects reporting system. These three fundamental problems need to be addressed immediately if we are to live in a nation where we aren't killing our citizens with our own products that are actually safety approved by the government itself.

To put all this into perspective, keep in mind that prescription drugs have killed far more Americans, in fact thousands of times more Americans, than all terrorists combined. If you think terrorists have committed crimes against the American people, then what do you think about the pharmaceutical industry that kills 100,000 people per year according to the journal of the American Medical Association, or as many as 750,000 people per year if you agree with the "Death By Medicine" numbers that also include medical mistakes? And now with the knowledge that many of these deaths could have been prevented had the people at the FDA been doing their jobs, or had the people at drug companies been practicing even basic human ethics, then is this not a case of crimes against humanity?

Is this not a crime against the American people that should be immediately investigated and rectified? Frankly, I've seen far more law enforcement efforts exerted towards catching one murderer who has killed one person, and yet here we have an entire agency, a group of powerful people, whose negligent actions have killed hundreds of thousands of people, and there has yet to be serious law enforcement action initiated against them. Just because these people are government employees should not immunize them from criminal prosecution. In fact, I would say that as government employees, they should be held to a higher standard of ethics and protecting the sanctity of human life, because they hold substantial power over that life. And it is precisely this power that they have abused over a period of many years in order to achieve their own selfish aims of power, control and financial profit.

If all the people who had been killed by prescription drugs were able to rise up from their graves and march on Washington right now, we would see a revolution in medicine overnight. But unfortunately, they lie in their graves unable to speak the truth about what really needs to be done, and thus it is up to us, the survivors of this chemical nightmare, to take responsibility for this situation and make sure that we and our children are no longer harmed by this reckless "Fraud and Drug Administration" that has lost sight of its mission and any sense of value for human life.


FDA Novartis Late with Dog Painkiller Reports
Tue Dec 28, 2004 11:40 AM ET
WASHINGTON (Reuters) - Novartis AG failed to give the government prompt, accurate reports about deaths of dogs treated with a painkiller in the same class of medicines now linked to heart problems in humans, U.S. regulators have charged in a letter.

The drug, Deramaxx, is a COX-2 inhibitor approved for relieving arthritis and post-surgical pain in dogs.

Similar drugs for people are under heavy scrutiny after studies associated them with heart attacks and strokes. One of the drugs, Merck & Co Inc.'s Vioxx, was pulled from the market because of safety risks.

Death has been reported "in rare situations" when dogs were treated with Deramaxx, according to the drug's label instructions.

The Food and Drug Administration, in a warning letter dated Nov. 29, said Novartis Animal Health Services should have forwarded complaints about deaths and health problems in dogs given Deramaxx within 15 working days, but in some cases delayed as long as 10 months. Some reports, including ones involving deaths, appeared to have incorrect dates, the FDA said.

"Novartis failed to submit timely and accurate information to the FDA regarding serious (adverse drug experiences) associated with the administration of its FDA-approved animal drug product Deramaxx ... during its first year of marketing," the FDA said.

The company also failed to submit proper information about post-approval studies of Deramaxx, the FDA charged. The drug is known generically as deracoxib.

Novartis officials could not immediately be reached for comment.

The FDA sends dozens of warning letters per year. Most of the issues raised are resolved without further regulatory action, although the letters sometimes lead to tougher steps such as product seizures.

The warning letter to Novartis is posted on the FDA Web site at http:/

& Food and Drug Admiaktrrtlon
Atlanta District Office
68 8th Street, NJL
Atlanta, Geargia 30309

November 29,2004


George Gunn, Global Head
Novartis Animal Health Services AG
Werk Rosental
Schwarzwaldafiee 215
CH-4058 Basei

Dear Mr. Gunn:

During the period of January 20 through January 23, 2004. an inspection was
conducted at the headquarters of your veterinary pharmaceutical operations in the
United States of America (USA), known as Novartis Animal Health US, Inc. (Novartis), which are located at 3200 Northline Avenue, Suite 300 in Greensboro, North Carolina.

The inspection disclosed significant deviations from the adverse drug experience (ADE) reporting requirements of Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the Act) and Tie 21, Code of Federal Regulations (21 CFR), Sections (@) 510.300 {effective prior to June 30,2003) and 514.80 (effective on June 30, 2003). Upon the conclusion of the inspection on January 23, 2004, a Form FDA 483 - Inspectional Observations (FDA 483) was issued to and discussed with Dr. Guy L. Tebbi, Vice President, Regulatory Affairs. In addition, as noted below, a number of similar deviations have occurred since the FDA 483 was issued. For example, you sent a letter on September 29, 2004, submitting two late ADEs and describing corrective actions Novartis has taken as a result.

The primary purpose of the inspectjon was to determine Novartis’ compliance with the ADE reporting requirements of the Act and its regulations. The inspection included, but was not limited to, a review of Novartis’ ADE reports for lack of expected effectiieness (LOE) complaints concerning your heartworm prescription drug products Interceptor@ and Sentinel@ for ail marketing years subsequent to their approval.

The Form FDA 1932 “Veterinary Adverse Drug Reaction, Lack of Effectiveness,
Product Defect Report” (FDA 1932) is used to report ADEs and product/manufacturing defects. 21 CFR QQ 514.80(b)(l), (b)(2), and (b)(rl)(iv). ADEs include, among other events, LOEs and ADEs occurring in humans from exposure during manufacture, testing, handling, or use, 21 CFR § 514.3.

The inspection disclosed significant deviations from the applicable requirements of the Act and regulations. Upon its conclusion on January 23, 2004, a Form FDA 483 - Inspectional Observations (FDA 483) was issued to and discussed with Dr. Guy L. Tebbit, Vice President, Regulatory Affairs. A copy of the FDA 483 is enclosed for your review.

We would like to point out to you that in item # 1 of the FDA 483 we made reference to Case # US209302009. Upon further review, we have determined that this incident was reported appropriately to the FDA and should not have been induded in the FDA 483. We apologize for any confusion caused by this inadvertent error.

We acknowledge the receipt of several pieces of correspondence from Novartis
containing responses to the inspectional observations found in the FDA 483. Your
responses were dated as follows: February 4, 2004; February 25, 2004; an undated letter from Dr. Tebbi (possibiy April l&2004); April 19.2004; April 23,2004; and June 3,2004. We will address some of our concerns with those responses in the discussion that follows.

Based on our evaluation of the information obtained during the course of the inspection, the documentation related to Novartis’ ADE reports submitted to FDA over the last six (6) years, and Novartis’ written responses foliowing the inspection, we have determined that your firm has failed to comply with the ME reporting requirements of Section 512(l) of the Act and 21 CFR 99 510.300 (effectiie prior to June 30,2003) and 514.80 (effective on June 30,2003).

The violations include, but are not limited to, the foilowing areas: Problems associated with your renortina wactkes of ADEs:

Novartis failed to submit timely and accutite information to the FDA regarding serious ADEs associated with the administration of its FDA approved animal drug product Derarnaxx” (Deraooxib), New Animal Drug Application (NADA) 141-203, during its first year of marketing.

An example of this type of deviation is the recording of the date sent to FDA {box 2b of the FDA 1932). Our inspection revealed signHicant discrepancies between what was written in box 2b of the FDA 1932 and the postmarked date of the submission and/or the date FDA received the submission. Some of Novartis’ initial and follow-up ADE reports, including ones involving death, were postmarked and/or received by FDA between 21 and 100 or more days after the date recorded in box 2b of the FDA 1932, indicating that the date recorded in box 2b is incorrect.

Another example is Case # US200302088, which was reported to Novartis on February IQ, 2003 (as indicated in box 2a of the FDA 1932). The form indicates that it was sent to FDA on January 9, 2004, over 10 months after it was reported to Novartis. This information should have been reported to FDA in a timely manner, within 15 working days of receipt. Moreover, tha report was not received by FDA until January 27,2004, again indicating that the date recorded in box 2b was incorrect.

A third example Is the revised submission for Case # US200207030, which was
submitted with your response dated February 25,2004. Our investigators reviewed the entire correspondence file between the owner of this animal and Novartis. The FDA 1932 submitted with your response fails to include specific details regarding the results of blood work performed on this dog on September 9, 2002 (a baseline) and further work performed in October 2002 and November 2002, which was transmitted to Novartis by the owner between November 2002 and January 2003, in violation of 21 CFR 6 514.80(b)(2)(I). This informatbn should have been promptly mported to FDA within 15 working days of receipt.

Your written response dated February 25, 2004, included revised standard operating procedures (SOPS), which were supposed to address the observed deficiencies. The revised SOP 5.2 (Voltime 1, page 650) does not identify how your fmn witl prevent incorrect information from being reported to FDA as was noted during the inspection.

Your written response dated April 23, 2004, indicates that Novartis has employed
additional personnel for the receipt, investigation, and transmittal of ADE reports. The response further states tt~at you firm has also invoke corporate quality, compliance, and pharmacovigilance groups to assist in this process. But following your response FDA has continued to receive late ADE reports along with cover fetters.
For example, some of these letters were dated April 28,2004; May 12,2004; May 28,2004; July 29, 2004; August 20,2004; and September 21,204.

Problems associated with VOW rmxtinu m@lees of ADEs related TV
studies: Vour firm failed to submit timely informatiin to the FDA regarding post-approval studies involving new animal drugs. Two specific failures were identified during the inspection.

The first one was the failure to submit information from completed pilot studies as part of the clinical experience in the annual Drug Experience Report (DER), as required by 21 CFR 5 510.300(a)(l) (effective prior to June 30,2003 and 514.8O(b)(4)(111) (effective on June 30, 2003). Our investigators identified over e pilot studies in your master study list. Dr. Tebbit stated that Novartis has never submitted information about their pilot studies as part of the annual DER, unless they are part of an Investigational New Animal Drug Application (INADA) or a pivotal study.

The second one was the failure to submit serious, unexpected ADEs involving animals under study to the FDA within 15 working days of fkst receiving the information, as required by 21 CfR Q 510.300(b)(2)(1) (effectiie ptior to June 30, 2003) and 514.80(b)(2)(i) (effective on June 30,2003).

One study involving Demmaxx” (Deracoxib), NADA 141-203, in cats involved a late submission of ADEs. The experiment, which was completed in July 2003, involved 14 animal deaths and other serious AD&. These ADEs were not reported to the FDA within the required 15 working days titneframet, but were reported only after the conclusion of the inspection of y~~ut facility, on February 24,2004.

Atthough your submission dated February 24,2004, indicates that it was Novartis’ intent to disclose the safety information fmm the cat study, your firm failed to diidose this information from other studies found in the master study Ilst.

For example, a protocol entiied The Acute Safety Study of an Injectable Deracoxib (SD-8746) Formulation In Dogs” was submitted to the FDA under the INADA 010-885 on April 15, 2002. Thll was approximately three months after the master study list indicates the pilot study was ckmpleted. The study dlnical data was not received by the FDA until October 2004.

FDA acknowledges that your firm has revised its SOPS and obtained principal
investigator agreements to submit all 15day ADEs in post approval studies as drug
experiences. But your response does not darify that you also understand that you must submit ADEs in the periodic drug experience report as clinical data, unless they were previously reported, as required by 21 CFR 6 514.8O(b)(4)(iv)(C).

Problems associated with VOW remrtina ~racdces of human exDo%ure ADEs:
ClomicalmQD (Clomipramine Hydrochloride), NADA 141-120, has the potential for
human abuse and carries the following human warning statement on its label:
Human S&b@ ReMva to PossessJon, Handling and Administtatton:  uNot fbr use In humans. Keep out of lleach of chiltin.  In case of accidental Ingestion seek medical attentlan Immediately. In childmn, accIdenta ingestion should be
regarded as serious. There is no specific antidote for clomlpramine. Overdose In humans causes antichollnerglc Mbcts including el%Hs on the central
nervous (e.g. convularions) and ca~lovascular (e.g. arrhythmias, tachycaWa) systems. People with known hypersensM&y to clomlprsmne should administer the
prroduct with caution. Our review of your submissions involving human adverse experience events for Clomicalm@ since April 23.2004, indicates that your firm should improve its reporting of follow-up information. All adverse drug events that are on the 1!5day report must be promptly investigated and significant new information must be reported to FDA within 15 working days of receiving such information. 21 CFR Q 514.80(b)(2)(ii). For example, significant new information would include instances where humans experienced any Side effects from taking this dnrg.

Neither this fetter nor the FDA 483 which was issued to and discussed with Dr. Tebbit is intended to be an all-inclusive list of deficiencies at your firm. It is your responsibility to ensure adherence to each requirement of the Act and its regulations. The specific violations noted in this letter are serious and may be symptomatic of serious underlying problems. You should take prompt action to correct these d8fiCi8ndeS. Failure to promptly correct these deviations may result in regulatory action without further notice. These actions may indude, but are not limited to, seizure and/or injunction. Federal agencies are advised of all Warning Letters about drugs so they may take this information into account when considering the award of contracts. [WHAT CONTRACTS?]

We request that you rep& in writing within fifteen (15) working days of receipt of this letter describing the corrective actions you have implemented, or are ptanning to implement, to prevent a recurrence of the violations noted above. Please indude
copies of any available documentation demonstrating that correcths have been made.

If corrective actions cannot be comp~qted within ffie8n (15) working days, stat8 th8 reason for the delay and the time within which the con-&ions will be completed.

Your written response and any pertinent documentation should be addressed to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead.

Sincerely yours, ,
Mary H. Woleske
District Director
Atlanta District

COMMENT/NOTE:  The above FDA letter to Novartis was downloaded in the ".pdf" format just as it appeared above, other than the highlighted areas, which may or may not have appeared in the original on-line and my own comment(s) written in red and bracketed.  While it is only my personal opinion, it appears to me that Dr. Graham's "exposure" of the FDA's sloppy attitude, indifference to life and "coziness" with the drug industry, via the current Senate investigative hearings, is setting many a rat scurrying to protect their own heinies, "clues" being provided by the yellow highlighting.

Thursday, January 06, 2005 commentary:

Shutting down RX Depot is all about protecting drug profits, not consumers

Background: RX Depot was importing prescription drugs from Canada (where they are cheaper) and selling them to customers in the U.S. (where the drugs are very expensive). The U.S. drug companies, of course, didn't like this, and they invented all sorts of false accusations to try to discredit RX Depot, saying that imported drugs were dangerous because they might be counterfeit, for example.

Ultimately, U.S. drug companies got the FDA involved, and the FDA managed to shut down RX Depot. But this isn't a story about protecting the U.S. consumer. It's a story about protecting a highly profitable drug distribution channel in the U.S. and keeping the medical racket alive and well.

It's a story of profiteering on the backs of U.S. consumers who are paying 3,000% markups (and more) for prescription drugs that cause liver damage, gastrointenstinal scarring, and a whole host of long-term side effects that endanger the lives of customers.

Because the real danger of prescription drugs isn't that they come from Canada: it's that over 100,000 Americans die each year from prescription drugs. That's more than 25 times the deaths on 9/11. Yet where's the outrage?

All's quiet on the drug front. Big Medicine has managed to shut down media criticism by buying the media with page after page of direct-to-consumer advertising that touts unsafe chemicals for a growing list of so-called "diseases" (like the disease of feeling nervous when speaking in front of people. According to Big Medicine, this is now a chemical imbalance in your brain, not just nervousness, and you need treatment).

Big Medicine is running the greatest con ever perpetrated on the American public. They're stuffing people full of dangerous chemicals and charging them the highest prices in the world to do so. And with the help of the FDA, they're managing to blockade alternative sources for the exact same drugs, forcing people to buy at the higher U.S. prices.

It's time to put a stop to the Big Medicine racket. Want to read more about how the FDA is all about protecting profits and not protecting consumers? Click here to read an AP article on the subject. It tells how a former FDA pharmacologist, who quit in disgust, was told to just approve drugs and not question any problems that might arise.


Thursday, January 06, 2005 commentary:

FDA once again asleep on the job; the GAO investigates a dangerous drug manufacturer

Here's another opportunity to contrast the actions of the FDA's actions on prescription drugs versus herbal medicine. As you are probably well aware, the FDA aggressively bans herbs that cause just a few deaths. Ephedra's isolated problems were highly exaggerated and widely publicized in order to solicit an outcry that would justify the FDA's actions to ban the herb. And yet prescription drugs receive no such scrutiny. This story described how a prescription drug named OxyContin is being crushed and snorted by druggies to achieve a heroin-like high. Furthermore, the company making OxyContin distributed promotional videos to doctors that contained all sorts of unsubstantiated claims, such as the claim that fewer than 1% of users become addicted to the drug (many doctors would strongly argue with that).

So how is the FDA acting to protect the U.S. public against this heroin-like drug that's being improperly marketed across the country? It isn't. The investigation was conducted by the General Accounting Office (GAO), which had to actually yank the FDA's chain to get the agency to take a look at this drug. And now, six years after the drug was first introduced, the FDA has taken no steps whatsoever against the makers of OxyContin.

This is stunning news: the GAO, which is perhaps one of the last remaining honest departments in the federal government, is doing the FDA's job! That's why I'm a strong advocate of FDA reform and for creating an Internal Affairs department at the FDA so that somebody is watching over this irresponsible agency that continues to drag its feet when it comes to protecting the public from the dangers of prescription drugs.


Thursday, January 06, 2005 commentary:

FDA is the godfather of the world's largest drug cartel

In its ongoing campaign to control the drug market and protect profits of drug companies, the FDA is now going after three companies in Texas that help retirees buy medicines at more affordable prices from Canada. The FDA claims the practice of importing these drugs from Canada is "dangerous," but in reality, the only danger presented by this is to the profits of U.S. pharmaceutical companies who operate in league with the FDA to monopolize the U.S. drug market. It's a drug racket of immense proportion, and only the FDA could be so arrogant to think that smart-minded people don't see through it. Like dealers of crack, meth and heroin, the FDA seeks to control the market for its own gain, and that means shutting down anybody who tries to buy the drugs from sources outside the USA.

Isn't it time to reform the FDA?

Thursday, January 06, 2005 commentary:

If you eat red meat, you've been eating recycled chicken feces, thanks to the FDA and USDA

nally, USA Today tackles the issue with a pointed article that questions why the FDA hasn't simply banned the use of dead cows in cattle feed. Let's face it: mad cow disease only happens when you feed dead cows to live cows. It's a sickening, inhumane practice, but it makes ranchers money, and so there's tremendous political pressure to make it happen. If you've been eating red meat all this time, hopefully you're at least a little bit shocked that you've been eating meat from cows that were fed chicken litter, and those chickens were fed dead, diseased cows containing spinal cord material that could carry mad cow disease. Knowing this, I'm not sure why any decent human being would eat beef anymore. It's technically not that different from reaching into your toilet bowl and chowing down on your own feces.

Saturday, January 08, 2005 commentary:

Pharmaceutical advertising turns national newspapers into drug industry puppets

A New York Times headline blares, "Health Officials Urge Sharply Lower Cholesterol Levels," and the article discusses all the reasons why more and more people should be on statin drugs. Changes in diet, nutrition and levels of physical exercise are utterly absent from the story, leaving the reader with only one conclusion: statin drugs are the only way to lower cholesterol.

To the right of the story, a giant tower banner ad demands, "Talk to your doctor today!" Right above that giant quote, a large logo advertises "Crestor," a popular statin drug. The tower banner takes up almost as much screen space as the article, and the message of the two -- in combination -- is quite clear: everybody needs lower cholesterol, and the only way to do that is to take Crestor.

This is the national media on drugs. Or, more accurately, the national media addicted to the advertising dollars of pharmaceutical companies. Even from national newspapers like the New York Times, we're no longer getting balanced information about lowering cholesterol with diet and exercise. Instead, we're getting one-track reporting: drugs, drugs and more drugs. And just in case you missed the point, here's a giant banner you can click that will give you even more pro-drug propaganda.

It's all a result of the FDA's decision regarding direct-to-consumer advertising in 1998. Following that decision, drug companies were allowed to run ads on television, in magazines and all over the web, urging consumers to ask their doctors about drugs they might not even need. The first result was to cause patients to barge into their doctors' offices and demand drugs about which they had absolutely no knowledge. Many doctors still shake their heads over the Claritin campaigns which had patients demanding Claritin, even though they had no clue what Claritin claimed to do.

But the bigger effect -- and far worse -- was that the national media received a huge influx of marketing dollars from drug companies. In a matter of a few months, formerly respectable magazines and newspapers were transformed into pro-drug propaganda rags. And it didn't take long for the editorial content to follow suit, because once a big advertiser is pumping millions of dollars into a publication, it only takes one phone call to shut down an anti-drug article and fire the reporter who dared write it.

And that leads us to today, where we see a blatant example of this at work in the New York Times. This newspaper is already steeped in one ethics scandal after another, and it appears to me that with this article in particular, they've lost any sense of journalistic responsibility and sold out to the drug companies for dollars. In less polite terms, this is called "media whoring," and it means that the publisher shapes their content in order to please advertisers. Hence the utter lack of any mention of nutrition and exercise as a way to counter high cholesterol in this particular article.

The pharmaceutical companies know this, too: their dollars buy them editorial influence. And they exercise it. Newspapers and magazines that write about high cholesterol, but fail to mention statin drugs, are simply denied advertising dollars. Meanwhile, publishers who hype up the drugs with pro-drug headlines are rewarded with even more dollars.

And where do all these advertising dollars come from? From the ridiculously high prescription drug prices, of course! Some prescription drugs are marked up an astounding 500,000% from the cost of their raw ingredients (that's not a typo), and a big chunk of that money goes right back into the big propaganda machine (advertising and P.R.). Drug companies claim they need those sky-high prices to invest in R&D, but in reality, they spend far more on promotion than R&D. And they do that because they're buying off the national press.

The U.S. press has largely sold out to the drug companies. That's why you can't get trusted news about health from most popular news sources anymore. You have to go to independent sites like this one. We don't have a single ad rep, and we tell the truth about health, nutrition, and pharmaceuticals, regardless of whose profit interests it serves. Companies don't pay us to be listed here, either.

Here, we serve your interests, not the financial interests of some mega-rich drug corporation. Too bad the same can't be said of many U.S. newspaper publishers. Their media whoring is absolutely blatant. You can't even honestly call their paper a "news" paper anymore. It's more like an infomercial.

It's a great system for pushing drugs onto American consumers, though. Most Americans will do what they're told, as long as the orders come from a source like a national newspaper or cable news channel.


  • The new recommendations call for treatment with cholesterol-lowering drugs for millions of Americans who had thought their cholesterol levels were fine.
  • For people at the highest risk, they suggest that the target level of L.D.L. --- the type of cholesterol that increases the likelihood of heart disease --- should be less than 100.
  • For people at moderately high risk, lowering L.D.L. to below 100 with medication should be seriously considered, the report said.
  • The advice for people at low risk remains unchanged.
  • The recommendations were published today in the journal Circulation and endorsed by the National Heart, Lung and Blood Institute, the American Heart Association, and the American College of Cardiology.
  • The recommendations, which modify guidelines set by the government only 2 1/2 years ago, will increase by a few million the number of Americans who meet the criteria for therapy with the powerful cholesterol-reducing drugs called statins, and many people who are already taking the medications will be advised to increase their doses.
  • And how aggressively should patients be treated?
  • One change applies to people at moderately high risk --- defined as having risk factors like age, high blood pressure or smoking that confer a 10 to 20 percent chance of suffering a heart attack in the next decade.
  • Under the new recommendations, doctors now have the option of prescribing drug therapy for such patients if their level of L.D.L. cholesterol is 100 or higher, the report says, and a level of below 100 can be set as a goal.
  • For example, following the new advice, a 57-year old nonsmoking man who has an LDL of 115 and whose blood pressure, with medication, is 130, could now receive drug treatment.




date: 01/03/05 20:33 EST
FDA Lets Whistleblower Publish Vioxx Safety Data
WASHINGTON (Jan. 4) - The Food and Drug Administration has given a whistle-blower scientist permission to publish data indicating that as many as 139,000 people had heart attacks that may be linked to Vioxx, the scientist's lawyer said Monday.

Dr. David Graham, who works in the FDA's office of drug safety, has said he was not allowed to publish his data questioning the safety of Vioxx, a pain medication principally used to treat osteroarthritis. Additionally, an FDA official sent email messages to the medical journal Lancet trying to persuade the journal not to publish the data.

Citing its own safety concerns, manufacturer Merck voluntarily pulled Vioxx from the market in late September.

Graham testified in November before a Senate committee that the FDA fumbled in its handling of safety concerns around Vioxx and had mishandled concerns about five other widely used drugs. He contended that FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.

The FDA denies the allegations, and controversy over the agency's role continues.

But the question of publication of the Vioxx data appears to be settled. The FDA told Graham Monday that he could go ahead and publish his research, which shows that 88,000 to 139,000 people have had heart attacks that could be linked to Vioxx, with 30 percent to 40 percent of them fatal, said Graham's attorney, Tom Devine.

The report will be resubmitted to the Lancet, a British medical journal, which is expected to publish it, Devine said. Lancet editor Richard Horton has been sharply critical of the FDA as well.

Devine, legal director of the Government Accountability Project, said the FDA go-ahead is a positive sign.

"For the short-term at least, the FDA has decided to stop suppressing controversial research on Vioxx," he said.

Graham could not be reached for comment but Devine said of his client: "He's pleased and relieved."

The FDA did not respond to a request for comment.


Saturday, January 08, 2005 commentary:

Medical community blames Dr. David Graham for warning about prescription drugs; medical McCarthyism now in full swing

Here's how twisted the medical community is these days: when FDA researcher (and now, public safety hero) Dr. David Graham raised safety questions about five prescription drugs in Senate testimony, the drug companies, FDA officials and old-school doctors actually accused him of starting a panic in the minds of patients.

How's that for distortion? Now telling the truth about the dangerous side effects of prescription drugs is being characterized as starting a panic. Apparently, Big Pharma and the FDA would much rather people be dead than panicked. After all, dead people don't ask many questions, nor do they sue drug companies for damages.

Big Pharma wants to keep everybody in the dark, and the Fraud and Drug Administration is doing its best to enforce that ignorance through indimitation and deceit. There is something wickedly evil about our national pharmaceutical industry and the corruption at the FDA. When the very people trying to warn the public about the safety hazards of dangerous drugs are discredited and blamed for raising awareness, we are neck-deep in nothing less than an era of medical McCarthyism. God help us all.


Saturday, January 08, 2005 commentary:

The FDA may reassign outspoken drug safety advocate Dr. David Graham; intimidation campaign continues against public safety hero

News summary:

  • A U.S. Food and Drug Administration reviewer who criticized the agency's handling of Merck & Co. Inc.'s now-withdrawn Vioxx painkiller may be forced to another position at the agency, a lawyer for the scientist said on Monday.
  • FDA efforts to move David Graham, the associate director for science in the Office of Drug Safety, have stepped up since he accused the agency at a Nov. 18 Senate hearing of failing to protect the public, said his lawyer, Thomas Devine.
  • "We were wondering if he was going to be reassigned today," but that had not happened as of Monday morning, said Devine, legal director of the Government Accountability Project.
  • Devine added that talks with other FDA scientists indicate Graham's "exile from drug safety work is imminent."
  • Graham, a 20-year veteran at the agency, sought counsel from the whistle-blower protection group before he testified at the Senate Finance Committee hearing.
  • Devine said FDA Acting Commissioner Lester Crawford "aggressively offered (Graham) a post switching from drug safety to long-term management" before the hearing.
  • "For all practical purposes, he'll be defenseless against reprisal," he said.
  • The agency has previously said it acknowledges the right of employees to raise their concerns to oversight groups like The Government Accountability Project.
  • In a letter on Monday, Finance Committee Chairman Sen.
  • Charles Grassley asked FDA's Crawford to "address allegations that administrative action may be taken against Dr. Graham, including that he may be terminated or transferred against his wishes to a job other than conducting scientific research."
  • At the Vioxx hearing, the Iowa Republican told FDA officials he expected Graham's rights would be upheld and that no retaliation or other similar actions would be taken.

note: for non-AOL users, see this is in the Wall Street Journal for the full article; selected portions below:
Drug Worries and Looking Globally for Solutions
French Vigilance Centers Spot Problems, and U.K. Traces Issues With 'Green Cards'
By ANNA WILDE MATHEWS, Staff Reporter, The Wall Street Journal
The U.S. spends more on pharmaceuticals, devotes more resources to medical research and discovers more new drugs than any other country.

But its system for monitoring and responding to safety issues after drugs are approved isn't state-of-the-art, and in some ways falls short of what's done elsewhere in the world.

# The FDA's drug-safety office, which leads efforts to detect adverse effects of drugs already on the market, has a budget of about $27 million a year. That has risen gradually but is a small part of the $327 million the agency spends on drug regulation overall.

# Stronger Surveillance - Some 66% of FDA drug reviewers are "not at all" or only "somewhat" confident the agency adequately monitors approved drugs' safety, according to a survey for a 2003 report by the Health and Human Services Department inspector general.

The agency receives about 300,000 reports a year of possible bad reactions to approved drugs. About 94% come from drug makers, which are obligated to disclose them. The companies, in turn, depend largely on doctors and other medical people to alert them.

But those medical professionals have no duty to report adverse reactions either to drug makers or the FDA and frequently don't, perhaps because of lack of time, liability concerns or simply a physician culture that doesn't make this a priority.

# The agency can't always force companies to complete promised follow-up studies of approved drugs. As of September 2003, drug makers had agreed to do 1,338 such follow-up studies. A recent FDA tally found that around two-thirds of them hadn't even started.

May my beloved partner ROMI rest in peace  - no matter wherever her bits and pieces/frozen carcass may be held hostage.


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