From the category archives:

Consumer Protection

According to an excellently reported article by Susan Brinkmann for the Philadelphia Daily Bulletin, Dr. Diane Harper, the lead researcher during clinical trials of two human papiloma vaccines, Gardasil and Cervarix, dropped a bombshell (or perhaps multiple bombshells) at the 4th International Public Conference on Vaccination.  Dr. Harper said the drugs will do little to reduce cervical cancer (even though Merck, the maker of Gardasil, has spent millions on an ad campaign designed to convince people the drug will prevent cervical cancer).

(Forgive this blog post’s extensive quotations from the article, but there was much I simply didn’t want to leave out, and couldn’t improve upon.  Also forgive my addition of bold type in several places.  As the father of three girls, and the grandfather of a 5-year-old girl, I don’t feel you can overemphasize the risks of the vaccine and the lack of any real benefit to young girls. MJE).

Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made her remarks during an address at the 4th International Public Conference on Vaccination.  Although Dr. Harper’s talk was intended to help 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.  After hearing Dr. Harper say  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.”

During her remarks, Dr. Harper revealed:

* 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;
* 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;
* four out of five women with cervical cancer are in developing countries;
* there have been no efficacy trials in girls under 15 years of age;
* 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;
* giving the vaccine to girls as young as 11 years-old “is a great big public health    experiment.” Dr. Harper first made the statement in a 2007 interview with KPCNews.com, 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. [Remember, this statement was made when Merck was pushing states to make the vaccination mandatory for school children. MJE] “There also is not enough evidence gathered on side effects to know that safety is not an issue.”
Dr. Harper had previously commented 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.”

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.

Joan Robinson, Assistant Editor at the Population Research Institute, said Dr. Harper 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.”

Okay, that’s the end ot he article, and the beginning of this blogger’s commentary.  Ms. Robinson was being kind (or cautious), when she said “it was hard to resist the conclusion that Gardasil does almost nothing for the health of American women.”  Excuse me if I disagree, but Gardasil does a lot for the health of American women (and let it be noted that some of these “women” are as young as 9 years old.  And if you don’t believe me when I say it’s being administered to 9-year-olds, run a Google search on Merck’s corporate website and take a look at the 133 pages where Merck says it can be administered to girls and women 9 through 26 years old).

Yes, Gardasil does a lot for the health of American women.  It kills and injures thousands of them!

Even before Dr. Harper’s remarks, I wondered about the message we were sending young girls by vaccinating them with Gardasil.  What were we saying, it’s okay to have unprotected sex because we’ve cut down on the risk of HPV, even though you still may get AIDs, herpes, and other STDs that are potentially more serious than HPV?

Dr. Harper is to be complimented for telling the truth about HPV vaccines.  It’s important for this truth to be communicated to girls, their parents and doctors as soon as possible.  It’s also important for some consumer attorneys to make themselves available to represent those girls who have been injured, and the families of girls who have died, as a result of taking the HPV vaccines.

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The New York Times reported September 24, 2009 that the Food and Drug Administration (FDA) admitted “that four New Jersey congressmen and its own former commissioner unduly influenced the process that led to its decision last year to approve a patch for injured knees, an approval it is now revisiting.” [Blogger's note: all emphasized text throughout this post is mine.]

This admission by the FDA may shock some, but it will come as no surprise to lawyers for consumers who were killed or injured by dangerous drugs and medical devices approved by the FDA under the previous administration.  To lawyers engaged in the heated drug and medical-device litigation, it became obvious that some business men and women were willing to sit in their offices and boardrooms and take actions that would kill and permanently injure people.  The motive was greed, and the perpetrators were secure in their knowledge that, if the litigation went awry, the damages would be paid from the profits of the shareholders.  There was little or no personal responsibility for the decision-makers.  Sadly, some executives inside Big Pharma are still enjoying high compensation and fancy corporate perks after killing and injuring hundreds.  Contrast that with the day-to-day existence of someone serving prison time for killing or injuring just one person during a robbery, and it becomes clear why some became so outraged at the FDA under the previous administration.

The New York Times article goes on to report:

The agency’s scientific reviewers repeatedly and unanimously over many years decided that the device, known as Menaflex and manufactured by ReGen Biologics Inc., was unsafe because the device often failed, forcing patients to get another operation.

But after receiving what an F.D.A. report described as “extreme,” “unusual” and persistent pressure from four Democrats from New Jersey — Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman — agency managers overruled the scientists and approved the device for sale in December.

All four legislators made their inquiries within a few months of receiving significant campaign contributions from ReGen, which is based in New Jersey, but all said they had acted appropriately and were not influenced by the money.

The New York Times later wrote an editorial about the corrupting effect of lobbying and political contributions on patient safety, concluding:

This shabby episode carries an important warning for policy makers as they debate health care reform. Decisions on what treatments work best have to be insulated from political lobbying. Otherwise there will be little hope for reining in spending on unproven treatments that may be ineffective or harmful.

Later the business press began to describe the story.  An Oct. 8, 2009 Wall Street Journal article discussed the effect of the FDA’s potentialy more stringent approval process on various medical-device manufacturers.  And, surprise, surprise, a securities analyst voiced the opinion that he is “‘very much concerned’ about tighter regulations that could slow the pace of innovation.” Even the pro-business Journal immediately followed that quote with this observation: “Device companies commonly rely on upgraded products cleared through 510(k) [the "fast-track approval process] that can fetch higher prices from hospitals.”

My thoughts after reading this disgusting saga:

  • Some people in a few big drug and medical-device companies really will kill you for your money, as some consumer attorneys have claimed for years.
  • Patients are safer under the current FDA Commissioner, but the bad guys are still out there, and they won’t quit trying simply because it’s gotten tougher.
  • Just because four congressmen from New Jersey wear the label “Democrat,” don’t expect them to protect consumers when business lobbyists are throwing money at them.  There are a few Republicans (Charles Grassley comes to mind) who seem to care more about patient safety and what’s going on at the FDA than the four guys from Jersey who ReGen’s money and pressured the FDA to approve an unsafe knee patch.  This isn’t a defense of Republicans; it’s more of an indictment of the current political and regulatory system, and my belief that a politician’s personal integrity and stand on the issues is more important than party labels.
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ConsumerNews.com: Still a work in progress.

by Michael J. Evans on October 9, 2009

in Consumer Protection

My favorite project right now is ConsumerNews.com, which I am developing as a news site after having spent decades representing plaintiffs. I firmly believe that huge corporations (who often find themselves as defendants in lawsuits) have funneled money into “think tanks” and the Chamber of Commerce to fund a decades-long attack on trial lawyers. I call this campaign “high-tech, high-priced jury tampering.” This unrelenting campaign has been so effective that people in some states have voted to give away their own Constitutional rights under the guise of “tort reform,” and some professional organizations have changed their names to get rid of the words “trial lawyers.” I still believe that it’s an honorable thing to represent individuals who have been injured or wronged by huge corporations.

That’s one of the reasons I’m interested in developing ConsumerNews.com. My vision for ConsumerNews is to build a reliable news site that will take an openly pro-consumer approach to reporting the news. Does this mean that the facts will be twisted to create pro-consumer news articles? Not at all. But it does mean that the articles will be factual, will be chosen to coincide with the concerns of individual consumers (including concerns that go beyond legal issues), and we will have no apologists standing ready to write an article justifying anything corporate America wishes to do. The plain, unvarnished truth is what is needed. As the masthead of the old Rocky Mountain News said: “Give light, and the people will find their own way.”

I’m learning that getting the bugs out of a substantial website can take longer than expected. In any event, we continue to make progress (though slower than we would like) and will announce the launch (when it comes) on this site.

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The FTC finally got around to issuing guidelines for bloggers and “guerrilla marketers” who hype products in exchange for products or money.  If you have the time and interest, or if you need something to read before going to sleep, check out the 81-page- long Text of the Federal Register Notice.

Adweek notes: “The FTC chose not to make a distinction between professional bloggers and amateurs. It also does not differentiate between paying cash and providing product samples.  Violators face fines of up to $11,000 per infraction.”

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I continue to be amazed at the depths to which some drug companies will stoop to make a dollar (okay, so it’s more like a few billion dollars).  Just yesterday Bloomberg reported that Pfizer agreed to a $1.2 billion criminal fine (the largest in U.S. history) and a felony plea by a subsidiary to settle Justice Department charges that Pfizer was guilty of fraud in marketing drugs.  The $1.2 billion was merely part of the total $2.3 billion in fines that Pfizer agreed to pay.  Oh yeah, Pfizer also entered into a five- year “integrity agreement” with the Health and Human Services Department as well.

Why in the world does the world’s largest drug manufacturer have to sign an “integrity agreement?”  Maybe it’s because it’s the settlement was the fourth with Pfizer or a subsidiary since 2002. The previous three agreements settled criminal or civil charges involving distribution and marketing or Lipitor, Neurontin and Genotropin and resulted in combined payments of $513 million.

Then today, BNET reports that the U.S. Senate’s Special Committee on Aging released a study showing that Forest Labs budgeted $100,000 for ghostwriting articles about its antidepressant Lexapro.  The Justice Department sued Forest in February for allegedly promoting its anti-depressants for children without FDA approval, and paying kickbacks to doctors to encourage prescriptions.  BNET also reported that Forest expected to pay about $100,000 to get Emory University on its payroll.

The New York Times reported that Forest wanted 2,000 docs on its payroll, at about $17,350 each.  The Times reported that a Forest document said “the company planned to spend $34.7 million to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers in one year.”

I’ve represented injured consumers, and the families of deceased consumers, who have been victimized by Big Pharma’s greed, so I’m not shocked that drug companies are willing to sell drugs that harm and kill people in order to make money.  I’ve always believed that if you’re willing to do that, then you’ll probably lie, cheat and steal to make money.  I’ll admit to being surprised, however, that medical integrity sells for only $17,500.

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An iPhone app created by the Children’s Hospital of Boston and MIT Media Lab uses Google Maps to show the user’s current location and displays nearby outbreaks of infectious diseases, according to Tom’s Guide.  Users can also use the spot to search for a specific destination to check for diseases before deciding to go there.  The app’s name is HealthMap: Outbreaks Near Me, and it’s free at the iTunes store.

According to a CNET review, the app uses “data provided by HealthMap, an online service that “collects filters, maps, and disseminates information about emerging infectious diseases.”  The app allows users to submit their own reports, complete with photos.

I have to admit that I downloaded the app.  It’s apparently very popular; when I tried to use it I got a message saying “Due to a higher demand than expected for the service, performance may be slow at peak times. We are working hard to resolve this issue quickly!”

Now if someone could just create an app that would notify me of uninsured drivers near me . . .

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In June of 2008 I attended AlwaysOn’s OnHollywood conference, primarily for the part of the program dealing with online journalism.  In one panel discussion, the moderator asked several CEOs of online news services whether “new media”, including bloggers and the 24-hour news cycle, had caused a deterioration in journalistic ethics.  The moderator hypothesized that, in the old days, the big, respected newspaper in each city was expected to communicate the objective truth in its news pages, even if it might offend large advertisers or large numbers of subscribers.  One panelist called BS on that premise, saying there has never been such a thing as objective journalism.  Even if reporters didn’t allow financial considerations to impact their reporting, said the panelist, the stories that were assigned to the journalists and the news agenda of the paper was impacted by financial considerations. [click to continue…]

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Bloomberg is reporting that Maatrixx, the manufacturer of Zicam nasal spray and swabs, didn’t give the FDA 800 complaints it received about side-effects of the recalled products.  The products were recalled June 16 after the Food and Drug Administration warned consumers that the treatments may cause a loss of smell.

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Nancy Nord, the acting chairwoman of the Consumer Product Safety Commission, will be stepping down from her leadership of the CPSC, reports Aaron Kessler of the (Sarasota, FL) Herald-Tribune.  Nord, a former Eastman Kodak Co. lobbyist who has come under fire over the CPSC’s response to defective Chinese drywall and other consumer issues, says she plans to stay on as a member of the Commission until her term expires in 2012.

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President Obama took a major step in restoring the right of states to protect their citizens from dangerous products yesterday.  In a Presidential directive to all heads of executive agencies, President Obama reversed the Bush administration policy of federal preemption of lawsuits filed under state law.  [click to continue…]

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