Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

 On the surface, you wouldn’t think that the Human Papilloma Virus (HPV, the causative agent of venereal warts and cervical cancer) and US Homeland Security have much in common. However, they have more in common than you think as reported in yesterday's Pharmalot blog.

According to a report by the TheStreet.com , Homeland Security’s US Citizenship and Immigration Services (USCIS) is the first government agency to mandate that all female immigrants’ ages 11 to 26 years old be vaccinated against HPV. Because Gardasil is the only cervical cancer (HPV) vaccine that is approved for use in the US it will the vaccine used for the mandatory immunizations. Surprisingly, there is no HPV vaccination requirement for US visa holders or American citizens.

Since the policy was begun, an estimated 233,000 females aged 11 to 26 who entered the US as prospective citizens paid a combined $52 million or so for the vaccinations according to the Street.com article. Curiously, the USCIS is requiring only a single injection for females who receive the vaccine—the Gardasil label indicates that three injections are required for full anti-HPV effectiveness.

As you may recall, more than 20 states rejected plans backed by Merck to make Gardasil vaccination mandatory. Merck abandoned its campaign after parents and medical experts expressed concern about safety and effectiveness. While Gardasil vaccination is optional for American citizens, there is apparently no opt-out provision for females who simply want to immigrate to the US. The confusion may like lie in a document issued by the US State Department called form DS-3025, or “vaccination documentation worksheet which says vaccination against “Human Papillomavirus is required for US immigrant visa applicants.” Here is the form.

John Abramson, the former chairman of the CDC’s Advisory Committee for Immunization Practices when the HPV requirement began in April 2007, and an opponent of mandatory vaccination said “This is not a disease that is communicable like SARS or pandemic flu or even measles.” “I am stunned. It was not the intention of the policy to mandate vaccination of immigrants,”

Ironically, Merck which has been pushing as hard as it can to promote Gardasil use isn’t aware of the Homeland Security policy, according to a Merck spokeswoman. It just goes to show how effective unregulated pharmaceutical lobbying can be!!!

Until next time…

Good Luck and Good Job Hunting

• Email This
• Print
• Comments (2)
• Trackbacks
• Share Link

The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

Before anybody puts a nail in Gardasil’s coffin, it is important to point out who started the recent firestorm about the vaccine. It was none other than the conservative-funded public interest group Judicial Watch. It is no secret that this group advocates abstinence over condom usage and other methods to prevent sexually transmitted diseases. Further,  I suspect that a majority of Judicial Watch’s members don’t believe sex education or pre-marital sex for that matter. Finally, I have no doubt that Judicial Watch received some support (financial, spiritual or otherwise) from the anti-vaccination lobby that is unfortunately gaining strength in the US and elsewhere.

From a scientific standpoint, it is difficult to get a real measure of the safety of a vaccine until it has been widely used by large numbers of people. Although pivotal Phase III trials are required for all vaccine approvals, the number of people studied in these trials (sometimes in the tens of thousands) is not sufficient to predict all possible safety problems that may emerge when the vaccine gains widespread use. For this reason, regulatory agencies typically require vaccine manufacturers to conduct mandatory post marketing Phase IV clinical trials that are designed to address the seriousness of any possible safety concerns that may have emerged after a vaccine has been on the market for several years. Because all vaccine makers know this, it is still not clear to me why Merck, a company which has been in the vaccine business for a very long time, embarked on its failed lobbying campaign to get Gardasil on the mandatory US vaccination schedule shortly after it was approved. 

As I have said in the past, ALL pharmaceutical and biotechnology drugs have side effects and their occurrence and severity varies from person to person. Generally speaking, most drugs are approved by regulatory agencies because their potential benefits outweigh real or presumed safety risks. That said, the question facing all parents who have daughters is: Does protection against cervical cancer outweigh any adverse events or potential safety risks associated with Gardasil or Cervarix vaccination? It is a tough question but one that my wife and I and others will have to answer for our daughters!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station, NJ)!!!!!!!!!

• Email This
• Print
• Comments (1)
• Trackbacks
• Share Link

Last year was a banner year for the pharmaceutical lobby (the largest in Washington DC). It spent over $168 million to inform Congress about issues that its members thought were in the best interest of the pharmaceutical and biotechnology industries. So what were the main issues that occupied a majority of the lobby’s time?

• blocking the importation of inexpensive drugs from other countries
• protecting pharmaceutical patents both within the United States and abroad
• ensuring greater market access for pharmaceutical companies in international free trade agreements

You are probably wondering which company was the top spender—it was Amgen! As you may recall, Amgen’s EPO franchise was under intense medical, regulatory and congressional scrutiny because of safety issue that resulted from over prescription. In my limited understanding of how things work in Washington, I have been told by lobbyist friends of mine that there is no better way to solve nagging problems than by paying influence peddlers to make them go away.  That said, Amgen’s lobbying costs paled in comparison with the $23 million spent by Pharmaceutical Research and Manufacturers of America a pharmaceutical industry trade group.  You Go PhRMA!!!!

A quick perusal of the top lobbying list reveals that all major US pharmaceutical companies invested heavily to influence members of Congress to allow them to preserve their stranglehold on the American healthcare system. Not surprisingly, all of the major foreign pharmaceutical manufacturers were also on list.  Much to my surprise, Teva, the Israeli generic manufacturing giant made the list this year—so it goes!

I guess altruism is out and avarice is still in! Hat tip to Pharmalot.

Until next time….

• Email This
• Print
• Comments
• Trackbacks
• Share Link

As many of you may recall, Merck tried unsuccessfully last year to lobby state and federal officials to pass legislation that would require mandatory vaccination of girls aged 9-26 with Gardasil, its anti-HPV, cervical cancer vaccine. Merck came under fire for its efforts (which seemed ethically disingenuous to many). Consequently, the company’s image took a hit and its stock price started to tumble. Although Merck stopped its lobbying campaign (mostly because of bad press and a flagging stock price), Gardasil ads continued to run and went largely unnoticed.

Because GlaxoSmithKline may be close to launching Cervarix^Tm—its cervical cancer vaccine—  the company recently decided that it was time to ramp up its Gardasil advertising efforts. Starting this past Saturday and continuing through June 26, Gardasil ads will be gracing the screens of a theater  near you. The ads will be shown with films like “Sex and the City” (hmmm, clever wouldn’t you say?), “Get Smart” (who doesn’t remember Barbara Feldon), “The Happening” (what woman doesn’t love a scary movie), “You Don’t Mess with the Zohan” (Adam Sandler is hot) and several others. I want to thank Ed Silverman over at Pharmalot for the heads up on this story!  I don't know about you, but I think that showing commercials at the movies, especially those hawking pharmaceutical products, is just plain wrong!!!!!!!!

This isn’t the first appearance of Gardasil ads at the cinema—I recall seeing an ad for Gardasil the last time I went to the movies (I don’t remember the movie but I clearly can recall the ad!). According to a Merck spokeswoman (aren’t pharmaceutical companies clever?), “We purchased advertised space that is relevant for our older female target audiences; specifically for the summer movies that are relevant to those aged 19 through 26.” 

As Ed so eloquently stated in his Pharmalot post: “Of course, plenty of teenagers will be seeing some of these flicks, too. Zohan and Get Smart are rated PG-13. And Sex and The Happening are rated R, but the restrictions only apply for kids under 17– some of whom will, no doubt, see them anyway.  In any event, Gardasil is unlikely to be available as a value pack that includes soda and popcorn. But we (Pharmalot) are curious to know whether the Gardasil beach towel is about to make a comeback.”

 Until next time….

Good Luck and Good Movie Watching!!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link