Tuesday, March 22, 2011

FluCide drug candidate shows promise but the mouse gets it in the end. NanoViricides, Inc. (OTC BB: NNVC.OB)

NanoViricides, Inc. (OTC BB: NNVC.OB) announced that a recent animal study of it's FluCide drug candidate, showed a quadrupling in efficacy over a previous study.

In the study, mice were aspirated with one million virus particles of the H1N1 flu virus. The mice were treated with both FluCide and Tamiflu 24 hours later. The results show that the mice treated with Tamiflu survived only 8.3 days, while the FluCide treated mice were able to hold on for 20.2 to 22.2 days.

The full announcement is here:

Friday, March 11, 2011

Group calls for removal of mercury from all vaccines

In a press release Thursday, the Coalition for Mercury-Free Drugs (http://mercury-freedrugs.org/) points to new research that illustrates more reasons to avoid adding Thimerosal (THIM) to vaccines. Thimerosal is a mercury-based compound that is widely used as a preservative in flu vaccines.

Although some previous research on the relationship between mercury and autism has been widely discredited, a new paper, by Helen V. Ratajczak, "Theoretical aspects of autism: Causes—A review," published in the Journal of Immunotoxicology, provides fresh clues. While not "proving" a relationship, the paper points to some damning evidence:

1. "Not only is every major symptom of autism documented
in cases of mercury poisoning but also biological
abnormalities in autism are very similar to the side effects of
mercury poisoning itself (Bernard et al., 2001)."

2. Mercury poisoning & Autism symptoms (in parallel): "...include psychiatric disturbances (e.g., impairments in sociality, stereotypic behaviors, depression, anxiety disorder, and neuroses), increased incidences of allergies and asthma, increases in the presence of IgG autoantibodies against brain and myelin basic proteins, reductions in natural killer cell function, and increases in neopterin levels (indicative of immune activation). Autistic brains show neurotransmitter irregularities that are virtually identical to those arising from mercury exposure, i.e., changes in serotonin and dopamine concentrations, elevated epinephrine and norepinephrine levels in the plasma and brain, elevated serum glutamate levels, and an acetylcholine deficiency in the hippocampus (Bernard
et al., 2001)."

3. "More evidence linking autism with mercury poisoning is the timing of inclusion of Thimerosal in vaccines in the 1930s closely preceding the discovery of autism in 1943."

4. Toxicity of Thimerosal: "There are dangerous effects of Thimerosal on the immune
system, particularly on T-lymphocytes. Mercury induces glutathione depletion, increased oxidative stress, and apoptosis in these cells (Makani et al., 2002). In addition, Thimerosal causes toxic effects on brain cells (Baskin et al., 2003), inhibits glutamate transport (Mutkus et al., 2005), affects nerve differentiation (Parran et al., 2005), induces immunoproliferation and formation of autoantibodies to fibrillin proteins (Havarinasab and Hultman, 2005), and depletes glutathione (James et al., 2005)."

The full press release is here:

Thursday, March 10, 2011

FDA & Justice Dept files consent decree against JNJ (NYSE: JNJ) division McNeil-PPC

The FDA today announced that a consent decree of permanent injunction has been filed against Tylenol producer McNeil-PPC (division of JNJ), for failing to comply with good manufacturing practices.

The FDA will assume control of three plants; located in Puerto Rico, Fort Washington, PA and Lancaster, PA.

The FDA announcement can be found here:



"Manufacturing deficiencies at McNeil’s facilities have resulted in several extensive recalls, including an April 30, 2010, recall of lots of several liquid products such as children’s Tylenol, Motrin, Zyrtec, and Benadryl products. In January 2010, the FDA issued a Warning Letter to McNeil’s Consumer Healthcare Division regarding violations identified at McNeil’s Las Piedras facility.

The decree, filed by the U.S. Department of Justice’s Office of Consumer Litigation and the U.S. Attorney’s Office for the Eastern District of Pennsylvania, requires McNeil to destroy all drugs under McNeil’s control that have been recalled from the Fort Washington, Las Piedras, and Lancaster facilities since December 2009. McNeil also must retain an independent expert to inspect the Fort Washington, Las Piedras, and Lancaster facilities to determine whether the violations have been corrected, and to ensure that adequate manufacturing processes are in place. After expert certification, the FDA will determine if the facilities are in compliance.

If the defendants violate the decree, the FDA may order McNeil to cease manufacturing, recall products, and take other corrective action, including levying fines of $15,000 for each day and an additional $15,000 for each violation of the law, up to $10 million annually."

Wednesday, March 9, 2011

Coming soon: Flu Hysteria redux: H2N2. Calls for pre-vaccination for nonexistent threat

BBC reports that Dr. Gary Nabel and colleagues at the Vaccine Research Center (US) say that H2N2 poses a risk for a pandemic and that world governments should start a preemptive vaccine program now.

They suggest a worldwide vaccine program despite the fact that H2N2 does not currently pose a threat.

However, there was a major "oopsie" in 2004-2005, when "3,700 test kits of the 1957 H2N2 virus were accidentally spread around the world."



The full BBC report is here:


"The US authors say immunity to the H2N2 flu strain is very low in people under the age of 50. But a safe vaccine already exists after an H2N2 outbreak in the 1950s and '60s. They say that vaccinating now could save billions of dollars if a pandemic does develop."

"Between 2003 and 2007 they examined levels of immunity to H2N2 among a small group of 90 people.

"Our study suggests that people under the age of 50 have little or no immunity, and resistance dramatically increases for those older than 50. This was also the case for the 2009 H1N1."

They argue that the vaccine developed in the 1950s would still work today and that governments should use this to develop a pre-emptive vaccination programme.

"One approach would be to manufacture the vaccine licensed in 1957 and immunise enough of the world's population to provide 'herd immunity' to the rest.

"This could be achieved by a 'one-time' campaign to immunise most of the adult population worldwide - for example, as part of standard seasonal flu vaccinations - accompanied by an ongoing programme to administer the vaccine to children."
Cheaper option

The authors say this would be a much cheaper option than stockpiling the vaccine or waiting for a pandemic to strike before boosting production.

"Another major influenza pandemic is likely to cost far more and create a much greater health burden than a well-planned pre-emptive programme.

"The US Centres for Disease Control and Prevention estimates that a pandemic outbreak costs the United States between $71 billion and $167 billion."

Pretty amazing numbers being thrown around. Common sense seems to dictate that we spend millions now to save billions later. However, inquiring minds want to know which companies hold the patents for these vaccines? Somebody call Congress!

Adamis Pharmaceuticals (ADMP) files IND with FDA for APC-100 prostate cancer treatment



By the way, here is something for your Facebook page:

I hated every minute of training, but I said, 'Don't quit. Suffer now and live the rest of your life as a champion.'
Muhammad Ali 

Adamis Pharmaceuticals announces the filings of an IND ("Investigational New Drug") application with the FDA for its APC-100 drug.

According to the announcement, "APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens.

APC-100 has previously received the National Cancer Institute's (NCI) multi-year, multi-million dollar RAPID Award (Rapid Access to Preventative Intervention Development). Each year, this award is given by the NCI Division of Cancer Prevention, under the RAPID Program, to what it believes are the most promising new preventative/ therapeutic anti-cancer drugs.

Previously, development of APC-100 has been funded by Michael Milken's Prostate Cancer Foundation (PCF, formerly CapCure), the Department of Defense’s Congressionally Directed Medical Research Programs’ (CDMRP) Prostate Cancer Research Program (PCRP), as well as grants and contracts from the NCI."

The entire transcript can be found here:



APC-100 is an orally available anti-androgenic/anti-inflammatory, signal transduction inhibitor drug. APC-100 has demonstrated to have higher therapeutic activity than the current marketed Standard of Care anti-androgens. Pre-clinical studies confirming the use of APC-100 for the treatment of prostate cancer were pioneered by Dr. George Wilding and his team. Dr. Wilding is the Assistant Dean for Oncology and Director of the University of Wisconsin Carbone Cancer Center. When tested side by side in the TRAMP prostate cancer mouse model (spontaneous prostate cancer model), APC-100 gave 90% efficacy versus the marketed Standard of Care giving 55% efficacy. In addition to increasing time to tumor progression and survival, APC-100 also induced a significant decrease in PSA production. Adamis believes these characteristics make APC-100 a first-in-class compound for the potential treatment of castrate-sensitive and castrate-resistant prostate cancer.

Tuesday, March 8, 2011

90 days in the life of an AID's patient (Topsy)

Unbelievable video -- from death's door to life. 90 days in the life of an AID's patient (in a minute and a half).

Video documents AIDs patients miraculous recovery. "Topsy" (by thetopsyfoundation).

Aethlon Medical (AEMD) granted FDA approval to export Hemopurifier to India

Aethlon Medical, Inc. (AEMD) announced today that it has been granted FDA approval to export its Hemopurifier medical device to India.

Although not yet approved for sale in the US, the therapeutic filtration device was granted approval under section 801 (e) of the Federal Food, Drug, and Cosmetic Act for devices that are manufactured under the FDA's Good Manufacturing Practices.

According to the announcement, "Aethlon is currently conducting a clinical study entitled: "Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy" at the Medicity Institute (Medicity) near Delhi, India. The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates. Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier® in India."

Full report is here:


"Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.

Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.

As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:

1. Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats."

Monday, March 7, 2011

More evidence why you might not want that flu shot (Hyman, Huff Post)

If you are paying attention, you should know by now that most of the recommendations for getting the flu vaccine are based on hype, hope and hysteria (along with a little industry propaganda, thrown in for good measure). But, Mark Hyman, of Huffington Post, knocks it out of the box, with his blog post: "Flu Shots: Panacea or Propaganda?"

Along with evidence provided by Flu Crazy (see: should you get the flu shot, probably not), Hymans note provides facts that show flu vaccines have NOT been proven to reduce person-to-person transmission of the flu or complications from pneumonia.

Also, research funded by industry paints a glowing picture of flu vaccines (and garners most of the attention), while publicly-funded research does just the opposite (and is widely ignored).

Our (easy) prediction: Hyman will be branded "crazy" and "dangerous." That's what he gets for citing the literature and providing a reasoned, non-hysteric analysis.


Japan suspends use of pediatric vaccines from Pfizer & Sanofi

Bloomberg is reporting that the Japanese ministry of health has suspended the use of pediatric vaccines from Sanofi Aventis (SAN.PA) and Pfizer (NYSE: PFE), following the deaths of four children, between March 2 and March 4.

Pfizer's Prevenar and Sanofi's ActHIB have been suspended in Japan at least until tomorrow, until a panel can meet to discuss the deaths.

Prevnar is used to protect children from meningitis and pneumonia. While ActHIB is used to prevent Haemophilus influenzae type b.

The Bloomberg article can be found here:

Sunday, March 6, 2011

About Allergan, Inc (NYSE: AGN)

About Allergan, Inc. (NYSE: AGN)

2525 Dupont Drive
Irvine, California, 92612

I.R.S. Employer Identification No.: 95-1622442

website: http://www.allergan.com/index.htm

Total Revenue: $ 4,919,400,000 (2010)

About Allergan (from Form 10-K):

We are a multi-specialty health care company focused on developing and commercializing innovative pharmaceuticals, biologics, medical devices and over-the-counter products that enable people to live life to its greatest potential — to see more clearly, move more freely and express themselves more fully. Our diversified approach enables us to follow our research and development into new specialty areas where unmet needs are significant.

We discover, develop and commercialize specialty pharmaceutical, biologics, medical device and over-the-counter products for the ophthalmic, neurological, medical aesthetics, medical dermatology, breast aesthetics, obesity intervention, urological and other specialty markets in more than 100 countries around the world. Our diversified business model includes products for which patients may be eligible for reimbursement and cash pay products that consumers pay for directly. Based on internal information and assumptions, we estimate that in fiscal year 2010, approximately 71% of our net product sales were derived from reimbursable products and 29% of our net product sales were derived from cash pay products.

We are a pioneer in specialty pharmaceutical, biologic and medical device research and development, with global efforts targeting products and technologies related to eye care, skin care, neuromodulators, medical aesthetics, obesity intervention, urology and neurology. In 2010, our research and development expenditures were approximately 16.7% of our product net sales or approximately $804.6 million. We supplement our own research and development activities with our commitment to identify and obtain new technologies through in-licensing, research collaborations, joint ventures and acquisitions.

We were founded in 1950 and incorporated in Delaware in 1977. Our principal executive offices are located at 2525 Dupont Drive, Irvine, California, 92612, and our telephone number at that location is (714) 246-4500. Our Internet website address is www.allergan.com.

FDA Accused of going soft on Allergan (AGN)

200 Largest Pharmaceutical Companies in the World


Report warns parents against over treating fever

A recent report in the journal "Pediatrics" may not prove to be very popular with parents and some caregivers. The authors contend that in most cases fever in children is a good thing and helps normalize body temperature, and in and of itself is not particularly dangerous.

Further, the study suggests that it is not a good idea to wake a child just to treat them with ibuprofen or acetaminophen.

"Fever" accounts for upwards of one-third of all trips to the pediatrician. Yet, parents may be over reacting to these symptoms and may be over treating their children (and are subject to "fever phobia"). The study asserts that the main goal in treating a fever is simply to make the child more comfortable, not to lower temperature.

The full report can be found here:



Appropriate counseling on the management of fever begins by helping parents understand that fever, in and of itself, is not known to endanger a generally healthy child. In contrast, fever may actually be of benefit; thus, the real goal of antipyretic therapy is not simply to normalize body temperature but to improve the overall comfort and well-being of the child. Acetaminophen and ibuprofen, when used in appropriate doses, are generally regarded as safe and effective agents in most clinical situations. However, as with all drugs, they should be used judiciously to minimize the risk of adverse drug effects and toxicity. Combination therapy with acetaminophen and ibuprofen may place infants and children at increased risk because of dosing errors and adverse outcomes, and these potential risks must be carefully considered. When counseling a family on the management of fever in a child, pediatricians and other health care providers should minimize fever phobia and emphasize that antipyretic use does not prevent febrile seizures. Pediatricians should focus instead on monitoring for signs/symptoms of serious illness, improving the child's comfort by maintaining hydration, and educating parents on the appropriate use, dosing, and safe storage of antipyretics. To promote child safety, pediatricians should advocate for a limited number of formulations of acetaminophen and ibuprofen and for clear labeling of dosing instructions and an included dosing device for antipyretic products.

China Vaccine Regulators Are Now WHO Certified

China's national regulatory authority, the "State Food and Drug Administration" (SFDA), has been found to meet requirements for a functional vaccine regulatory system, per published indicators. According to a report by the World Health Organization, Chinese vaccine manufacturers will now be eligible for prequalification of specific products. The addition of Chinese vaccines to the world market is expected to "have a significant, beneficial impact on global supply of vaccines of assured quality."


Excerpts from the report:

"A WHO-led team concluded today, at the end of a comprehensive review by experts from six countries, that the national regulatory authority of China, the State Food and Drug Administration (SFDA), and affiliated institutions, meet WHO published indicators for a functional vaccine regulatory system."

"Effective regulatory oversight of vaccines is essential since vaccines are used on a population-wide basis, and are usually given to healthy infants. Furthermore, vaccines are produced in only a small number of countries and often exported from the country of manufacture to many countries. Countries importing vaccines need to be confident that the national regulatory authority in the country of origin is competent in its oversight. WHO has established benchmarks that define international expectations for a functional vaccine regulatory system. WHO also conducts regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way."

"With a regulatory system for vaccines documented to comply with international standards, vaccine manufacturers in China are now eligible to apply for Prequalification of specific products. WHO prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies. Each application for prequalification of a specific product is independently evaluated by WHO. It is expected that vaccines from China could be prequalified 1-2 years from now. The eventual ability of United Nations procuring agencies to source vaccines from Chinese manufacturers is expected to have a significant, beneficial impact on global supply of vaccines of assured quality."

Thursday, March 3, 2011

British Members of Parliament react to swine flu hysteria created by Chief Medical Officer

Members of Parliament react to hysteria created by Chief Medical Officer

The House of Commons Science & Technology Committee (UK) released a report in which they questioned the methods with which the public was informed about the threat of the Swine Flu pandemic in 2009. The UK’s Chief Medical Officer held a press conference (on July 16, 2009) in which he suggested that up to 65,000 people in the UK could die during the pandemic.

According the to the report, “On 16 July 2009, the Chief Medical Officer, Sir Liam Donaldson, held a press briefing that led to media reports suggesting up to 65,000 people in the UK could die from swine flu in a worst case scenario. At that time, the number of actual deaths stood at around 30, and by the time the pandemic was over in April 2010, the total number of UK deaths was 460.

Dr Justin McCracken, Chief Executive of the Health Protection Agency (HPA), commented that: it shows how difficult communication is because it was not just the reasonable worst case scenario that was communicated to the press. It was, actually, the range of both the best and the worst. But, inevitably, I think the figure that the press focused on was the worst case scenario.”

Of course, the media ran with the report, and offered up scary headlines, which were echoed around the globe.

The committee’s recommendation:

“We recommend that there should be a single portal of information for every emergency, along the lines of flu.gov in the USA. This should be of use to members of the public as well as emergency responders and should be the primary source of all information, linking to other websites as necessary. We consider that maintaining this portal should be the responsibility of the Lead Government Department, and should be located within its departmental website.”



Wednesday, March 2, 2011

Baxter Intl’s (NYSE: BAX) Preflucel given EU approval

Baxter International (NYSE: BAX) announced that they have been approval by a European repeat mutual recognition procedure (rMRP), at the Austrian Agency for Health and Food Safety to begin providing it’s PREFLUCEL seasonal influenza vaccine for the 2011-12 flu season.

PREFLUCEL is manufactured via a patented cellular process (“Vero”), rather than the traditional embryonated chicken egg production process.

A study recently published in The Lancet showed a 78.5 percent protective efficacy.
The Baxter International release is here


Tuesday, March 1, 2011

FDA accused of going soft on Allergan and Lap-Band

An article in the LA Times, takes the FDA to task for allowing Allergan (NYSE: AGN) to push it's Lap-Band for broader use, while still demanding further testing. Critics say that the testing should come first, then the approval, pointing to the companies shady marketing of Botox.


The article points out the glaring difference between today's FDA, which appears to be an industry cheerleader, rather than an industry watchdog, and the FDA of the 1960's when an inspector stood up to a company that tried to push through the drug thalidomide.

According to the LA Times, in "1960, a young inspector for the Food and Drug Administration faced down a powerful drug company by rejecting its application to sell a morning-sickness drug in the United States.

The company, Richardson-Merrell, griped about her repeated demands for more safety data. They complained to her superiors, branding her as a nitpicker. But she stood firm.

The drug in question was thalidomide, and worldwide as many as 12,000 children were born with severe birth defects after their mothers used it. In the U.S., where Frances Oldham Kelsey blocked Merrell from distributing the drug except to a few doctors for "experimental" trials, the toll was 17. Thanks to her, the FDA gained a reputation as a vigilant watchdog.

Today's FDA isn't that FDA.

Today's FDA just approved an application by the drug company Allergan to expand the target market of its Lap-Band weight-loss device potentially by tens of millions of patients. How much safety data did the FDA review before giving Allergan the green light? Mainly the results of one year of study of 149 patients, and partial data from a second year. Today's FDA evidently can be steamrollered.

Kelsey has said that she demanded more information from Merrell, thalidomide's U.S. manufacturer, because its history of conflicts with the agency made her suspicious. Is there any reason to mistrust Allergan? Let's look at the record.

In September, Allergan pleaded guilty to one criminal count and paid $600 million in fines and penalties to settle federal charges that it had illegally marketed its marquee product, Botox, for uses the FDA hadn't approved. The guilty plea was for "misbranding" Botox, a misdemeanor.

In accepting the plea bargain, the government charged that the company had made under-the-table payments to doctors who used Botox to treat unapproved conditions, created front groups and websites to push the broader uses of the drug while concealing Allergan's backing, and coached physicians to over-diagnose a condition for which Botox could be legally marketed so it could sell more product. Allergan says for the record that it doesn't believe there is merit to those allegations "factually or legally."

Allergan took these steps, the government contended, because the approved uses had meager sales potential. The most prevalent condition for which Botox treatment was approved, cervical dystonia, is a painful neck spasm that affects only about 27,000 people in the U.S. Allergan wanted doctors to prescribe Botox for headaches — not an approved use, but a potentially huge market — so it prodded them to diagnose their patients' headaches as symptoms of the very rare CD. (The use of Botox as a cosmetic wrinkle-remover wasn't at issue, but the typical injected dose for beauty treatment is tiny compared with that for a headache.)

Federal regulators were upset with Allergan because Botox derives from botulinum, one of the most toxic substances known to man. The high therapeutic doses, FDA officials say, increase the potential for the toxin to cause dangerous muscle weakness or paralysis.

Allergan's tactics worked fabulously. Between 1999 and 2006, the government says, Botox's headache sales grew by 1,407%. By 2007, total Botox sales exceeded $500 million. More than 70% of that was for unapproved uses.

This history didn't seem to enter into the FDA's review of Allergan's application to expand its marketing of the Lap-Band, a device that's surgically implanted around the stomach to suppress appetite. Up to now, the approved use has been for morbidly obese people who had failed to reduce with diet and exercise.

If you're 5 feet, 8 inches tall, you'd be eligible for the Lap-Band if you weighed 262, more than 100 pounds overweight, or 230 if you have an obesity-related condition such as diabetes. Under the newly approved standard, the latter figure drops to 197.

An FDA advisory panel, which gave preliminary approval to Allergan's application in December, wasn't entirely happy with the company's data supporting its safety and efficacy claims for the Lap-Band — its own 149-patient study and six other studies, at least three of which were conducted by researchers with financial links to Allergan.

"I chastised Allergan for the cherry-picking they had done in the data," says John Kral, a member of the panel and a surgery professor at the State University of New York. The panel felt that a study of 149 patients wasn't good enough to establish the device's safety and efficacy over the long haul. Kral says he and the rest of the panel majority favored approval of Allergan's application even so, because they felt that the Lap-Band's benefits outweighed the risks."

The article further points to aggressive marketing of the Lap-Band:

"Nor does the FDA action take into account the overheated marketing that already surrounds the Lap-Band, such as the 1-800-GET-THIN billboards promoting this surgery. (Just the other day, two published studies showed that more traditional weight-loss surgeries were more effective and no riskier than the band.) Do you think the GET-THIN gang might exploit the FDA approval to push their service even harder? My Magic 8-ball answers: "Signs point to yes."

Two weeks after Allergan pleaded out its criminal case, the FDA had a big ceremony honoring the now 96-year-old Kelsey. FDA Commissioner Margaret Hamburg pledged "to continue your great work here at the FDA."

Ironic, yes?