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Yaz, Yasmin ads must be updated to add risks of thromboembolism

The Food and Drug Administration is requiring Bayer, the maker of Yaz/Yasmin birth control pills, to change its ads and promotional materials to add information about the risk of thromboembolism.  Bayer recently changed the drugs’s warning labels to include information about the risk of thromboembolism in women using Yasmin compared to contraceptives using other progestins. [Read more…]

Gardasil Researcher Drops Bombshell(s)

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.

Finally, an FDA that may care more about consumer protection than politics.

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.

FDA warns of Hydroxycut liver risks

The Food and Drug Administration (FDA) has issued a warning to consumers not to use Hydroxycut products due to the risk of serious liver damage.  The FDA says that “Consumers who use a Hydroxycut dietary supplement and who experience signs of illness associated with liver disease should immediately consult their health care provider.  Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine.  Non-specific symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, itching, and loss of appetite.   FDA has also identified several other serious adverse events associated with Hydroxycut, including cases of seizures, rhabdomyolysis (a type of muscle damage that can lead to other dangerous problems, such as kidney failure), and cardiovascular problems, ranging in severity from irregular heart beat to a heart attack.” [Read more…]

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