Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.

"I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn't help but question why we need the vaccine at all," said Joan Robinson, Assistant Editor at the Population Research Institute.

Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.

She went on to surprise the audience by stating that the incidence of cervical cancer in the U.S. is already so low that "even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US."

There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.

Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.

Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that "four out of five women with cervical cancer are in developing countries."

Ms. Robinson said she could not help but wonder, "If this is the case, then why vaccinate at all? But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them."

However, at this point, Dr. Harper dropped an even bigger bombshell on the audience when she announced that, "There have been no efficacy trials in girls under 15 years."

Merck, the manufacturer of Gardasil, studied only a small group of girls under 16 who had been vaccinated, but did not follow them long enough to conclude sufficient presence of effective HPV antibodies.

This is not the first time Dr. Harper revealed the fact that Merck never tested Gardasil for safety in young girls. During a 2007 interview with KPC News.com, she said giving the vaccine to girls as young as 11 years-old "is a great big public health experiment."

At the time, which was at the height of Merck's controversial drive to have the vaccine mandated in schools, Dr. Harper remained steadfastly opposed to the idea and said she had been trying for months to convince major television and print media about her concerns, "but no one will print it."

"It is silly to mandate vaccination of 11 to 12 year old girls," she said at the time. "There also is not enough evidence gathered on side effects to know that safety is not an issue."

When asked why she was speaking out, she said: "I want to be able to sleep with myself when I go to bed at night."

Since the drug's introduction in 2006, the public has been learning many of these facts the hard way. To date, 15,037 girls have officially reported adverse side effects from Gardasil to the Vaccine Adverse Event Reporting System (VAERS). These adverse reactions include Guilliane Barre, lupus, seizures, paralysis, blood clots, brain inflammation and many others. The CDC acknowledges that there have been 44 reported deaths.

Dr. Harper also participated in the research on Glaxo-Smith-Kline's version of the drug, Cervarix, currently in use in the UK but not yet approved here. Since the government began administering the vaccine to school-aged girls last year, more than 2,000 patients reported some kind of adverse reaction including nausea, dizziness, blurred vision, convulsions, seizures and hyperventilation. Several reported multiple reactions, with 4,602 suspected side-effects recorded in total. The most tragic case involved a 14 year-old girl who dropped dead in the corridor of her school an hour after receiving the vaccination.

The outspoken researcher also weighed in last month on a report published in the Journal of the American Medical Association that raised questions about the safety of the vaccine, saying bluntly: "The rate of serious adverse events is greater than the incidence rate of cervical cancer."

Ms. Robinson said she respects Dr. Harper's candor. "I think she's a scientist, a researcher, and she's genuine enough a scientist to be open about the risks. I respect that in her."

However, she failed to make the case for Gardasil. "For me, it was hard to resist the conclusion that Gardasil does almost nothing for the health of American women."

Site: Beasley Allen

CPSC is issuing this warning because T & L Trading has refused to recall these pacifiers.

About 16,500 "My Baby Soother" pacifiers were sold at grocery stores, delis, and discount stores in Bronx, Brooklyn, Broadway, and Coney Island of New York from August 2007 through July 2009 for about $1.

The "My Baby Soother" pacifier has a ring-shaped handle and a blue, pink, red, white or yellow heart-shaped mouth guard with two ventilation holes. The nipple is made of either silicon or latex. The pacifier package has the words "My Baby Soother" printed on the top and a picture of an infant on the background.

Distributors and retailers who purchased the "My Baby Soother" pacifiers from T & L Trading should immediately stop distributing the pacifier and call CPSC. Consumers should immediately take the recalled pacifiers away from infants and toddlers and discard them.

To see this release on CPSC's web site, including links pictures of the hazardous products, please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml10/10021.html

Site: Beasley Allen

In April 2009, Blair recalled 162,000 chenille robes after it learned of three robes catching on fire, including one report of second degree burns. Blair then received several reports of deaths allegedly due to robes catching fire. This prompted a second news release in June 2009 to again alert consumers to the burn hazard for the chenille robes. After this re-announcement, Blair received four additional reports of deaths allegedly due to the robes catching fire. Three of these victims were cooking and a fourth was tending a pellet stove; three of the four victims were in their 80s and one was in her 70s. All nine reported deaths occurred prior to the April 2009 announcement of the recall.

Blair has received one report involving one of the additional garments described below catching fire; no injuries have been reported related to these garments. Blair decided to expand the recall to include all women’s chenille wearing apparel manufactured by A-One Textile & Towel.

Name of Products: Full Length Women’s Chenille Robes, Women’s Chenille Jacket, Women’s Chenille Lounge Jacket, Women’s Chenille Top

Units: About 138,000; 162,000 units were previously recalled in April 2009

Manufacturer: CA-One Textile & Towel, of Karachi, Pakistan. A-One Textile & Towel manufactured all of the products recalled in April 2009. Blair is expanding its recall to all women’s chenille wearing apparel manufactured by A-One.

Retailer: Blair LLC, of Warren, Pa.

Hazard: Some of these products fail to meet the federal flammability standard and present a risk of serious burns to consumers if the garments are exposed to an open flame.

Incidents/Injuries: Since announcing the recall in April 2009, Blair has received nine reports of deaths allegedly due to the originally recalled robes catching fire. Blair has received one report on one of the additional garments catching fire; no injuries have been reported.

Description: The recall involves the following items:

Sold at: Blair catalogs and Web site, and Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from July, 2000, through April, 2007, at the following prices:

• Full Length Women’s Chenille Robes for about $30 to $40;
• Women’s Chenille Jacket, about $25 to $29;
• Women’s Chenille Lounge Jacket, about $20 to $23;
• Women’s Chenille Top, about $20 to $23.

Manufactured in: Pakistan

Remedy: Consumers are urged to stop wearing the garments immediately. Contact Blair LLC for information on returning the products and to receive a refund or a $50 gift card for Blair merchandise.

Site: Beasley Allen

The result can be a document skewed toward making a medicine seem safer and more effective than it really is, they wrote in a commentary in the New England Journal of Medicine.

"Much critical information that the Food and Drug Administration has at the time of approval may fail to make its way into the drug label and relevant journal articles," wrote Drs. Lisa Schwartz and Steven Woloshin of the Dartmouth Institute for Health Policy and Clinical Practice in Hanover, New Hampshire.

The labels are written by the manufacturers and the wording is negotiated with the FDA, which gives final approval.

But key information can be missing, Woloshin said in a telephone interview. "How can I decide if the potential harms of this drug are worth the risk if I don't know how well the drug works, and vice versa?" he asked.

One example is Sepracor's (SEPR.O) four-year-old sleep drug Lunesta, promoted with an advertising campaign that cost $750,000 a day in 2007.

The company generated sales of $600 million last year and became a wholly-owned subsidiary of Dainippon Sumitomoto Pharma Co (4506.T) on Tuesday.

The label says, without specifics, that Lunesta was superior to a placebo.

But test results submitted to the FDA showed that in the largest and longest study, "Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvements in next-day alertness or functioning," Schwartz and Woloshin wrote.

Sepracor responded that more detailed information about its products, beyond what the FDA wants, is always available to healthcare providers who ask for it, including from the company's scientific staff.

NO IMPROVEMENTS

A similar example is Takeda Pharmaceutical Co's (4502.T) insomnia drug Rozerem. Its label omitted laboratory data showing it still took 31 minutes, for adults over age 64, and 24 minutes for younger adults to fall asleep once they took the drug, compared with 38 minutes with a placebo.

In addition, volunteers reported "no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep," the researchers said. Those data were also omitted from the label.

"Sometimes what gets lost is data on harms," said Schwartz and Woloshin in their commentary. Novartis' (NOVN.VX) Zometa, used for cancer patients, had a warning label noting the 8- milligram dose posed a greater risk of kidney damage. But the degree of risk was not explained.

While 19 percent of the people taking the 4-milligram dose died during the study and 19 percent died taking a comparison drug, 33 percent died when given the 8-milligram dose of Zometa.

Seven years passed before the label was changed to explicitly tell doctors not to use the higher dose, but no details were given.

Novartis and Takeda had no immediate comment.

Woloshin said he and his colleagues had come up with a better format to make the scope of the risks and benefits clearer to consumers.

Last year, the FDA's Risk Advisory Committee voted unanimously to endorse it, he said. They are scheduled to meet with the agency on the issue again next month.

Site: Beasley Allen

In his eight-page ruling, Price said the evidence during the trial showed that AstraZeneca's actions in overcharging Alabama's Medicaid program were "reprehensible.'

"The state introduced evidence to establish that the defendants fraudulently diverted Medicaid funds intended to benefit the state's poor, elderly and infirm citizens,' Price wrote. "The state established that defendants' wrongful conduct deprived the state of limited funds available for the state's Medicaid recipients.'

The trial judge found Big Pharma's actions "reprehensible." But the Alabama Supreme Court says it was A-OK. That's what we get when we blindly vote for Republicans on our statewide courts, folks.

Price was not the only one blasting the behavior of Big Pharma in Alabama. Jere Beasley, one of the lawyers for the state, issued a scathing public statement about the drug companies--and the Alabama Supreme Court. Here is a portion of that statement:

The opinion of the Alabama Supreme Court is most difficult to understand when you consider that:

• Committing fraud against the Medicaid program hurts the elderly, the disabled, the young, and the poor as well as every Alabama taxpayer;
• AstraZeneca--one of the companies--entered a guilty plea to a charge of criminal fraud in federal court involving state Medicaid reimbursement;
• AstraZeneca paid a criminal fine of $570 million relating to that criminal guilty plea;
• AstraZeneca settled state Medicaid fraud cases involving reimbursement for $355 Million;
• A top official at AstraZeneca prepared an internal pricing document containing a virtual roadmap for cheating state Medicaid agencies;
• AstraZeneca as a part of the settlements mentioned above--agreed to submit true prices to state Medicaid agencies;
• AARP--a national group with 500,000 Alabama members--has fully supported Alabama in its lawsuit against the drug companies and in the appeal;
• 13 state Attorneys General have supported Alabama's position and each filed a brief on Alabama's behalf;
• Since the Alabama case was tried--and after the case was appealed in July 2008 to the Alabama Supreme Court--a Federal Appeals Court heard a separate appeal in a case where AstraZeneca was found guilty in Federal Court of fraudulent conduct in a Medicaid reimbursement case--in a strong opinion and affirmed the trial court;
• The Federal Appeals Court found that AstraZeneca was guilty of extremely bad conduct;
• Yesterday, a Kentucky jury, after hearing the same evidence Alabama lawyers developed and presented in the Alabama case, delivered a verdict against the drug manufacturer in the amount of $14.72 million; and

Taking all of the above into consideration, and knowing the facts of this case, it is extremely difficult to see how the Alabama Supreme Court could side with the drug companies and against the citizens of Alabama who are in the Medicaid program and against all Alabamians who pay taxes that support the Medicaid program. These folks are the losers today and politically powerful drug companies declared winners by the Alabama Supreme Court. This is a sad day for the Alabama Medicaid Program and all Alabama taxpayers.

Beasley says lawyers for the state will ask the high court to reconsider its decision. Good luck with that. Alabamians wanted a conservative court. They've got one.

Site: Beasley Allen

Name of Product: Handy Switch, Wireless Light Switches

Units: About 1.3 million

Distributor: Idea Village Products Corp., of Wayne (formerly of Fairfield), N.J.

Hazard: The light switch receiver, which fits into the wall outlet, can overheat and pose a fire hazard to consumers.

Incidents/Injuries: The firm has received 14 reports of overheating, including nine reports of fire, five of which involved property damage such as minor damage to curtains, bedding or walls.

Description and Model: The Handy Switch is a white plastic wireless remote light switch with model number KS-080 printed on the back of the receiver. On the front of the receiver is a blue electroluminescent nightlight.

Sold at: Mass merchandisers and drug store chains nationwide, through television infomercials and the Internet from March 2007 through July 2009 for between $10 and $15.

Manufactured in: China

Remedy: Consumers should immediately unplug and stop using the product and contact IdeaVillage to learn about free remedy options.

Site: Beasley Allen

Name of Product: Classic Buggies

Units: About 3,900

Manufacturer: Bad Boy Enterprises LLC, of Natchez, Miss.

Hazard: The off-road vehicles can accelerate without warning, posing a risk of injury to the user and/or bystander.

Incidents/Injuries: Bad Boy Enterprises has received 32 reports of unexpected acceleration, including reports of injuries such as a fractured toe, rotator cuff injury and sore muscles.

Description: This recall involves Bad Boy Buggy Standard model off-road utility vehicles. The Bad Boy Buggy Standard model has one row seat that allows two persons (the driver and passenger) to sit side-by-side while the vehicle is operated. The Standard has an open air design (no doors or windows), but has a roof. The Bad Boy Buggy Standard models come in Realtree camouflage pattern, Hardwoods camouflage pattern, hunter green, red and black colors. The affected models have serial numbers between 85004828 and 95010404. The serial number is located on a sticker in a cubby on the driver's side.

Sold by: Authorized dealers nationwide from June 2007 through July 2009 for about $10,000.

Manufactured in: United States

Remedy: Consumers should immediately stop using the buggies and contact their Bad Boy Buggy dealer for a free repair.

Site: Beasley Allen

Name of Product: Haunted House Screen Tea Light Holders

Units: About 7,800

Distributor: Coyne’s & Company, of Minneapolis, Minn.

Hazard: The window panes on the screen can ignite, posing a fire hazard.

Incidents/Injuries: The firm has received three reports of the window pane catching fire. No injuries have been reported.

Description: This recall involves haunted house screen tea light holders made of black metal with a transparent coating on the glass windows. The haunted house measures 15-inches wide by 15-inches high by 4-inches deep and can hold up to six tea lights. Tea light candles are not involved in this recall.

Sold exclusively at: Yankee Candle stores nationwide and online at YankeeCandle.com between August 2009 and September 2009 for about $25.

Manufactured in: China

Remedy: Consumers should immediately stop using the candle holders and contact Coyne’s & Company or Yankee Candle for a full refund.

Site: Beasley Allen

The court overturned jury verdicts against the drug companies AstraZeneca, Novartis and GlaxoSmithKline, accused by the state of fraudulently manipulating prices of drugs for Medicaid recipients.

The court ruled 8-1 that the state did not have to rely on the drug companies' information in deciding what prices to pay pharmacists for prescription drugs for Medicaid recipients. The justices said state officials could have done their own research and determined the correct price.

The court ruled the state is continuing to rely on the same formulas established by the drug companies to set prices.

"The state has never altered its course of conduct since taking issue with the reporting methods," said the majority ruling written by Justice Tom Woodall.

Justice Tom Parker cast the lone dissent, saying there was no evidence the drug manufacturers made available to the state the confidential details they used in determining price information.

More than 70 lawsuits were filed in 2005 by the state against drug companies. The state has settled its lawsuits against 16 of the drug manufacturers for more than $124 million.

Alabama Attorney General Troy King filed the lawsuits, charging them with causing the state's Medicaid program to pay too much for prescription drugs for poor and elderly citizens. He said he was disappointed "but I respect them as having the final word."

The decision is a blow to the state's cash-strapped General Fund budget, which funds Medicaid and other non-education state agencies and could have used the money to ease budget cuts.

"I'm saddened to learn that they have allowed the drug companies to rip off the elderly and children of Alabama. Clearly the juries found fraud in these cases," said the chairman of the Senate General Fund budget writing committee, Sen. Roger Bedford, D-Russellville.

The lead attorney for the state in the trials of the lawsuits, former Lt. Gov. Jere Beasley, said Alabama taxpayers "are the losers today and politically powerful drug companies declared winners by the Alabama Supreme Court. This is a sad day for the Alabama Medicaid program and all Alabama taxpayers."

Beasley said the state will ask the Supreme Court to reconsider its decision.

Officials with the drug firms said the ruling validates their position that the claims were unfounded.

"This confirms our position that GSK reported clear and accurate prices, that GSK's pricing practices were consistent with established industry standards and that the state understood full well the pricing benchmarks that GSK reported," said GlaxoSmithKline spokeswoman Mary Anne Rhyne.

The state's case against Wilmington, Del.-based AstraZeneca, the U.S. subsidiary of a British company, was the first to go to trial in February, 2008. The jury initially awarded the state $215 million in damages, but Circuit Judge Charles Price reduced the verdict to $160 million.

Later in 2008, another jury awarded the state $81 million in damages against GlaxoSmithKline PLC, a London-based health care company with U.S. headquarters in Philadelphia and Research Triangle Park, N.C., and $33 million in its lawsuit against Novartis, the U.S. affiliate of a Swiss company with U.S. headquarters in East Hanover, N.J.

In February, a Montgomery jury ordered Sandoz Pharmaceuticals to pay $78.4 million to the state. The Supreme Court has not ruled in that case.

Similar lawsuits have been filed against drug manufacturers by other states. A jury in Kentucky on Thursday ordered AstraZeneca to pay $14.7 million in a case that claimed the company inflated its prescription drug prices for Medicaid reimbursements.

Former Supreme Court Justice Terry Butts said he was disappointed with the Supreme Court's decision.

"By their rulings, the current Alabama Supreme Court continues to impose a form of economic slavery on the taxpayers of Alabama, which has not been seen since the days when human beings were routinely sold just down the street from the Alabama Judicial Building in downtown Montgomery," Butts said, referring to the day before the Civil War when slavery was legal in Alabama.

Site: Beasley Allen

Dupont has poisoned nearby drinking water wells and local public water supply systems with the toxic chemical commonly called PFOA (or C8), ammonium perfluorooctanoate. 

A copy of the decision can be found here

US District Court judge Renee Marie Bumb found that Dupont could face a class action suit by up to 15,000 neighbors who own private drinking water wells within a 2 mile radius of the Dupont plant, or are customers of the Pennsgrove NJ water supply system.

The judge ruled that neighbors could sue as a class on grounds of nuisance and public nuisance, including whether Dupont’s release of PFOA to air and groundwater constitutes “an abnormally dangerous activity” subject to a strict liability standard in New Jersey. According to the NJ DEP::

Currently [as of 8/8/09], private wells within two miles of Dupont’s Chambers Works facility in Carneys Point Township, Salem County, are being sampled and analyzed for PFOA. DuPont has agreed to voluntarily conduct this sampling and to provide treatment to those private wells that exceed the USEPA Provisional Health Advisory level of 0.4 ug/L. Because the Department does not have a promulgated drinking water standard or an interim specific ground water criterion for PFOA, the Department currently does not have regulatory authority to require DuPont to provide treatment to wells impacted by PFOA to 0.04 ppb. (link)

Dupont is aggressively challenging DEP’s PFOA  risk assessment and recommended drinking water standard of 0.04 ppb (ten times LOWER than EPA’s provisional health advisory level of 0.4 ppb).

We have been writing about Dupont’s attempts to manufacture scientific uncertainty in order to delay and frustrate DEP’s efforts to develop a stringent 0.04 ppb drinking water standard. 

Dupont is also seeking to stack a new DEP Science Advisory Board with Dupont scientists in hopes of influencing DEP scientific risk assessments and weaken regulatory standards. 

It is likely that if the neighbors prevail in this case, Dupont would be exposed to significant economic liability for PFOA pollution. DEP has found that other public water supply systems and private drinking water wells in NJ are polluted with PFOA. According to DEP:

PFOA has been detected in New Jersey public water supplies in the vicinity of DuPont Chambers Works as well as in other parts of the state. In 2006, PFOA was detected at up to 0.19 ppb and 0.0179 ppb in ground water samples from two different public water systems near the Dupont Chambers Works Facility. Also in 2006, the Department conducted a study of PFOA and a related chemical, perfluorooctane sulfonate (PFOS), in 23 other New Jersey public water supplies. This study has been published in a peer reviewed journal, Environmental Science & Technology and is posted on the Department’s Division of Water Supply web page. Of the 23 public water systems sampled in this study, the highest level detected was 0.039 ppb.  

 Based on recommendations by the Department, PFOA and PFOS were analyzed in 2007-2008 in over 200 samples collected by 18 public water systems throughout the state, including 12 systems sampled in the 2006 study. PFOA concentrations ranged from non-detectable (<0.01 ppb) to 0.14 ppb in water from an unconfined well near Chambers Works. PFOA was detected above the Department’s health-based guidance level of 0.04 ppb in at least one sample from five systems. Results of quarterly sampling of several systems have consistently exceeded the health-based guidance of 0.04 ppb in one or more points-of-entry. 

Site: Beasley Allen