Girl's Death Moves Parents to Secure New Guidelines

As he waited his turn at the microphone, in an Atlanta auditorium filled with doctors and scientists, Gary Stein wondered whether what he had to say would make much difference. These were the experts, he realized, the people who spend a lifetime studying viruses and vaccines. They already knew all the facts, the statistics.

Still, they didn't know 4-year-old Jessica.
Doris and Gary Stein read to Katie. On the wall is a painting of daughter Jessica, who died of the flu at age 4.
Doris and Gary Stein read to Katie. On the wall is a painting of daughter Jessica, who died of the flu at age 4. "Not a day goes by that you don't think about what [Jessica] would be doing," Gary Stein said.

So Stein began talking, as a father who once had a little girl with hair the color and shimmer of champagne, a child who loved dress-up and Barbies and who was as healthy as they come until the day in January 2002 when she caught the flu. Less than 72 hours later, she was dead. Stein thought he could get through the main points of his remarks without stumbling. But as he stood before the federal Advisory Committee on Immunization Practices, explaining how his Falls Church family had been devastated, he choked up.

"Nothing and no one will ever fill the void left by Jessica," Stein told the gathering.

"It hit me pretty hard," he admitted later. It may have hit the experts hard, too.

The next morning, the 15-member committee voted for a surprise revision in national policy: It unanimously recommended that starting this fall, all children between 2 and 5 years old be vaccinated annually against influenza.

The previous recommendation only advised flu shots for children ages 6 months to 23 months and those 6 months and older with chronic illnesses. As long as they are generally healthy, children older than toddlers tend to just get sick from the flu. They go to doctor's offices or outpatient clinics but are seldom admitted to the hospital.

Children still suffer a "substantial" amount of influenza, however, said Raymond A. Strikas, an associate director at the National Immunization Program, which is part of the federal Centers for Disease Control and Prevention. And that was the major impetus for the committee's decision late last month. Its expanded coverage even includes parents and older siblings, because they also suffer by getting sick themselves or taking time off work to care for ailing youngsters.

All told, nearly 17 million additional people now will be urged to get protection against the flu, bringing the total to more than 120 million men, women and children across the United States.

From the analyst's couch: Influenza vaccines

Mark J. Belsey1, Brigitte de Lima1, Alex K. Pavlou2 and John W. Savopoulos3

Influenza infects at least 10–20% of the population every year, and the US Advisory Committee on Immunization Practices recommends the following people should receive a vaccine: those aged between 6–23 months and older than 50 years of age, those at increased risk of influenza-related complications, and those who have household contact with high-risk patients and healthcare workers1. The annual trivalent inactivated influenza vaccines (TIVs) are composed of the two influenza A strains most commonly found in humans (for example, H1N1 and H3N2 in the 2004–05 season), together with the B strain2. Recently, another type of vaccine has been launched in the US, termed live attenuated influenza vaccines (LAIVs). LAIVs have the advantages of an easier and more patient-friendly administration route, and the potential to induce a broader mucosal and systemic immune response compared with TIVs. The disadvantages, though, are their considerably higher price, the fact that their safety has not yet been determined in the immunocompromised, the misconceptions regarding the use of a live vaccine and the requirement of storage at -15°C. Key currently marketed flu vaccines are detailed in Fig. 1.
Figure 1 | Sales and market share of key egg-based influenza vaccines.
Figure 1 : Sales and market share of key egg-based influenza vaccines. Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, or to obtain a text description, please contact npg@nature.com

Of Chiron's flu vaccine sales, Fluvirin generated only $2 million in 2004. MedImmune did not recognize 2003 revenues for FluMist. *Based on a total market value of $1.3 billion; ‡Influvac was first launched in the 1950s as a whole virus vaccine, and was switched to a subunit vaccine in 1983; §2004 sales are estimated and there is no estimate for 2003 Fluviral sales. TIVs, trivalent inactivated influenza vaccines; LAIVs, live attenuated influenza vaccines.

* High resolution image and legend (32 KB)
* Figures and tables index
* Download Power Point slide (244 KB)


Influenza vaccine drivers
Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, or to obtain a text description, please contact npg@nature.com

'Relaxer Lounge Chair' courtesy of the MoMA Design Store, www.momastore.org

Pharmaceutical companies are becoming increasingly aware of the virtues of investing in vaccines, as typified by Novartis's recent full acquisition of Chiron, and GlaxoSmithKline's purchase of ID Biomedical. Datamonitor estimates that vaccine sales reported by the major manufacturers generated US$9.9 billion in 2004, up from $3.6 billion in 1999, representing a strong compound annual growth rate (CAGR) of 29.3%. According to industry estimates, this is set to rise to $30–42 billion by 2015. Furthermore, vaccines have long product lifecycles, no generic threat, a high probability of R&D success, and lower sales and marketing costs because 90% of vaccine sales are to public-tender markets.

Influenza vaccines accounted for approximately 14% of total 2004 vaccine sales, or $1.3 billion, and Datamonitor forecasts that this is set to rise to $3.7 billion by 2010. Vaccines that look set to drive this 19% CAGR score highly on a number of characteristics (Fig. 2), which can be split into factors that could differentiate a product from its rivals (for example, cost, need for freezing, geographical and age-range approval), and demands that the market will make on the manufacturers (for example, responsiveness to pandemics). Weak launch-year sales of FluMist, for example, showed the result of positioning a product at too high a price point (US launch price of up to $60–70, compared with typical TIV Centers for Disease Control and Prevention (CDC) price of $9.71 for Sanofi–Pasteur's Fluzone), even if it did represent an evolution in delivery and efficacy. This miscalculation resulted in poor first-year sales, which led to Wyeth's withdrawal from the FluMist partnership with MedImmune in April 2004 and led to substantial price reductions, with the product now priced at $17.24 by the CDC.
Figure 2 | Evaluation of influenza vaccine technologies.
Figure 2 : Evaluation of influenza vaccine technologies. Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, or to obtain a text description, please contact npg@nature.com

*Does not include MedImmune's CAIV-T refrigeratable replacement. TIVs, trivalent inactivated influenza vaccines; LAIVs, live attenuated influenza vaccines.

* High resolution image and legend (29 KB)
* Figures and tables index
* Download Power Point slide (240 KB)


US penetration is similarly important. The US is the biggest market, requiring an estimated 80–90 million doses, and pricing thresholds have a better outlook. Following the vaccine shortfall in 2004–05, GSK's recent securing of US FDA approval for Fluarix in August 2005 is setting the trend towards raised competition in the market. Meanwhile, demands made by the market on flu vaccine manufacturers are likely to define the future overall size of the flu vaccine market and shape the evolution of vaccine manufacturing technology (see later). A range of pipeline flu vaccines are also set to drive market growth (Fig. 3).
Figure 3 | Estimated US launch dates of developmental influenza vaccines.
Figure 3 : Estimated US launch dates of developmental influenza vaccines. Unfortunately we are unable to provide accessible alternative text for this. If you require assistance to access this image, or to obtain a text description, please contact npg@nature.com

Source for data in all figures: Datamonitor and company-reported information.

* High resolution image and legend (39 KB)
* Figures and tables index
* Download Power Point slide (250 KB)


Preventing a pandemic

Antigenic drift of influenza A and B strains underlie epidemics, whereas antigenic shift of the A strain can trigger a pandemic3 if the novel reassorted viral strain has a high case fatality coupled with high human-to-human transmissibility. Although the economic cost of an epidemic is estimated at $12 billion, a pandemic may affect 25–35% of the population and cost an estimated $550 billion, according to the World Bank4.

Currently, all flu vaccines detailed in Fig. 1 are produced using egg-based manufacturing systems, which suffer from limited capacity, poor flexibility and restricted responsiveness, decreasing the effectiveness of this system in a pandemic. Furthermore, it is unlikely that avian eggs can be used to grow likely avian flu pandemic strains such as H5N15. As flu pandemics are characterized by their unpredictability of emergence, the degree of severity and the effectiveness of influenza epidemic interventions, cell culture vaccines, with their faster vaccine production and greater responsiveness, are set to play a dominant role in Western pandemic preparedness plans, and are likely to shape future flu vaccine market growth.

In summary, the increasingly attractive flu vaccine market is arousing considerable interest in companies hoping to capitalize on the strong CAGR between 2004–2010. However, there are high barriers to entry and significant risks associated with vaccine production, as highlighted by Chiron's loss of regulatory approval for flu vaccine manufacture in October 2004. Over the short term, characteristics such as increased US penetration and ramping up vaccine production are set to shape market growth. The introduction of cell culture flu vaccines (a number of which are currently in development, as shown in Fig. 3) is set to revolutionize the market over the mid-term and improve pandemic preparedness. Over the longer term, adjuvantation and the development of universal vaccines are set to dominate the technological evolution of the market.
Market indicators

Fourteen companies provide 90% of the global flu vaccine supply. Sales and market share of the key marketed vaccines are detailed in Fig. 1. Current trivalent inactivated influenza vaccines (TIV) production is 280–300 million doses, covering only 14% of the global population; therefore there is substantial scope for market expansion. Broad geographical and age-group approval, together with the level of vaccine manufacturing capacity and flu vaccine type, are the key factors set to shape future sales. Also driving vaccine market growth will be new product launches (Fig. 3).
Top of page
References

1.

Harper, S. A. et al. Prevention and Control of Influenza [online], <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5306a1.htm> (2004).
2.

Stephenson, I. & Nicholson, K. G. Influenza: vaccination and treatment. Eur. Respir. J. 17, 1282–1293 (2001).
* Article
* PubMed
* ISI
* ChemPort
3.

Treanor, J. Influenza vaccine — outmaneuvering antigenic shift and drift. N. Engl. J. Med. 350, 218–220 (2004).
* Article
* PubMed
* ISI
* ChemPort
4.

Brahmbhatt, M. World Bank [online], <http://www.who.int/mediacentre/events/2005/World_Bank_Milan_Brahmbhattv2.pdf> (2005).
5.

Fedson, D. S. Pandemic influenza and the global vaccine supply. Clin. Infect. Dis. 36, 1552–1561 (2003).
* Article
* PubMed
* ISI

more info on big pharma

Google search: type Big Pharma (listed are 310,000 posts on the corruption of big pharma)

www.opensecrets.org Go to top of page " who Gives" then type pharmaceuticals you get a complete chart) tracks money in politics to pharmaceuticals to brainwashing the average consumer/patient

Gina Tyler

__________________
"Great ideas often recieve violent opposition from mediocre minds"...................Einstein

Oped News
http://www.opednews.com/articles/gen...s_drug_com.htm

FDA Shields Drug Companies From Lawsuits


by Evelyn Pringle

http://www.opednews.com

evieLast month, the FDA revealed its latest protective policy for drug
companies in a statement that said people who believe they have been
injured by drugs approved by the FDA should not be allowed to sue drug
companies in state courts.

"We think that if your company complies with the FDA processes, if you
bring forward the benefits and risks of your drug, and let your
information be judged through a process with highly trained scientists,
you should not be second-guessed by state courts that don't have the
same scientific knowledge," said Scott Gottlieb, the FDA's deputy
commissioner for medical and scientific affairs.

The agency's assertion of "federal preemption" was included as a
preamble to its new drug labeling guidelines.


** Evelyn Pringle *

*The claim of preemption was quickly attacked by trial lawyers and
members of Congress as another effort by the Bush administration to
limit the public's ability to bring and win lawsuits, according to the
January 19, 2006 Washington Post.

"Eliminating the rights of individuals to hold negligent drug companies
accountable puts patients in even more danger than they already are in
from drug company executives that put profits before safety," said Ken
Suggs, president of the Association of Trial Lawyers of America.

"The fact that the drug industry can get the FDA to rewrite the rules so
that CEOs can escape accountability for putting dangerous and deadly
drugs on the market is the scariest example yet of how much control
these big corporations have over our political process," Mr Suggs told
the Post.

In response to the FDA's announcement, Senator Kennedy issued a
statement that said: "It's a typical abuse by the Bush Administration --
take a regulation to improve the information that doctors and patients
receive about prescription drugs and turn it into a protection against
liability for the drug industry."

The National Conference of State Legislatures, a bipartisan group that
represents state lawmakers, accused the FDA of trying to seize authority
that it did not have.

Over the past several years, lawmakers have been turning up the heat on
both the FDA and the pharmaceutical industry in response to their
combined failure to reveal problems found during studies conducted on
top selling drugs like Vioxx.

At one point, Senator Charles Grassley (R-Iowa), Chairman of the Senate
Finance Committee, came right out and accused the FDA of suppressing
studies in order to protect pharmaceutical industry profits and the
careers of certain FDA officials.

"The Vioxx example showed that the FDA and Merck were too close for
comfort," Senator Grassely told Health News on March 12, 2005.
"Testimony and documents at our Finance Committee hearing showed that
the FDA allowed itself to be manipulated by Merck," he said.

Based on a trial that took place in 2000, both the FDA and Merck were
aware that heart attacks were five times more likely in patients taking
Vioxx than among those taking a similar drug, Sen Grassley pointed out,
but the FDA did nothing to change the labeling on the drug for nearly
two years, while Merck aggressively marketed its product on nightly TV.

Back on November 18, 2004, he generated enormous media attention when he
held hearings on Vioxx, and FDA scientist, Dr David Graham, who works in
the FDA Office of Drug Safety, testified that Vioxx may have been
responsible for tens of thousands of heart attacks and strokes but that
his superiors had pressured him to keep silent about his findings.

"The estimates range from 88,000 to 139,000 Americans," Dr Graham told
the committee. "Of these, 30 to 40 percent probably died," he advised.

"For the survivors," he added, "their lives were changed forever."

To put this large number of injuries into perspective, Dr Graham told
members of the committee that instead of a serious side-effect of a
prescription drug, to think of it as if they were talking about jetliners.

"If there were an average of 150 to 200 people on an aircraft," he said,
"this range of 88,000 to 138,000 would be the rough equivalent of 500 to
900 aircraft dropping from the sky."

"This translates to 2-4 aircraft every week," he noted, "week in and
week out, for the past 5 years."

"If you were confronted by this situation," Dr Graham asked the
committee, "what would be your reaction, what would you want to know and
what would you do about it?"

He condemned the FDA's failure to acknowledge the risks that Vioxx posed
to millions of people in the 5 years it was allowed to remain on the
market. "I strongly believe that this should have been, and largely
could have been, avoided," Dr Graham told the committee.

The Vioxx matter caught the attention of the Senate Finance Committee
basically because of the Vioxx related costs to government programs like
Medicaid and Medicare. The committee is responsible for oversight of the
two programs. At the November 18, 2004 hearing, Senator Max Baucus said:

"In the 5 years that Vioxx was on the market, Medicaid spent more than
$1 billion on the drug."

"And Medicaid bears the cost of any additional medical care necessary
when drugs cause injury," he pointed out.

The hearings followed a study that estimated between 28,000 and 160,000
deaths may have been caused by the Vioxx since it gained FDA approval in
1999.

By far, the Vioxx debacle is the most serious public health failure to
occur since the FDA took on the authority for safety oversight of
medical products in 1938.

On September 3, 2005, Shane Ellison, M.Sc, a former pharmaceutical
chemist turned whistleblower and author of the book, "Health Myths
Exposed," gave an interview to Crusador Magazine and discussed Vioxx and
some of the problems within the FDA.

His book which was published before Vioxx began making headlines,
referred to Vioxx as the "silent killer."

According to Mr Ellison, the FDA and Merck knew about the dangers
associated with Vioxx for at least 4 years before it was taken off the
market. "Instead of removing the drug immediately," he said, "they kept
it on the drug market for matters of wealth not health."

Mr Ellison says pharmaceutically compliant politicians have
"democratized" the drug industry. "This means that drug approval is a
matter of 51% telling the other 49% that deadly drugs are safe and
necessary," he reports. "Science and choice no longer prevail at the FDA
or at pharmaceutical companies," he added.

"To go against the 51% means losing your career," Mr Ellison said.
"Therefore, the majority of scientists choose to please drug companies,
not the general public."

To substantiate this claim, Dr Ellison pointed to Dr Curt Furberg, a
member of the FDA's drug safety advisory committee.

In the wake of the Vioxx revelations, Dr Furberg went public with
findings that Pfizer's drug Bextra also caused heart attacks and strokes
and said studies "showed that Bextra is no different than Vioxx, and
Pfizer is trying to suppress that information," in the British Medical
Journal.

"Immediately thereafter," Mr Ellison said, "Dr. Furberg was barred from
serving on the panel that was responsible for considering the safety of
cyclo-oxygenase-2 (COX 2) inhibitors."

"The end result being more votes in favor of COX 2 inhibitors, the drug
company wins by votes -- not science," he told Crusador.

A little-mentioned fact is that many FDA employees end up working for
the pharmaceutical industry. "The old joke is that the FDA is sort of
like a showcase for a future job in the drug industry," Robert Whitaker,
author of Mad In America, said in an August 2005 interview with Street
Spirit.

"You go there, you work awhile, then you go off into the drug industry,"
he said, "the progression that people make, in essence they're making
good old boy network connections, so they're not going to be so harsh on
the drug companies."

Critic say the passage of the Prescription Drug User Fee Act in 1992
contributed to the current problems within the FDA. The Act allows the
agency to collect a fee from a drug company seeking approval for a new
drug. In return, the FDA is expected complete the review process within
12 months.

User fees now account for about 40% of the approval process, which means
the FDA is dependent on drug companies for nearly half of its funding.

This situation is the root of a major conflict of interest according to
Dr Graham: "This culture (at the FDA) views the pharmaceutical industry
it is supposed to regulate as its client. It overvalues the benefits of
the drugs it approves, and seriously undervalues, disregards and
disrespects drug safety," he told members of Congress.

Another problem he cited is that even when the FDA does try to take
measures to limit harm, the agency lacks the enforcement authority to
force drug companies to comply. In the case of Vioxx, Dr Graham said it
took more than 2 years to get Merck to add the increased risk of heart
attack and stroke to its label.

Then there are the conflicts of interests involving the FDA panels that
advise the agency on matters such as which drugs should be approved,
what their warning labels should say, and how studies should be conducted.

The 300 experts on the 18 committees make decisions that affect billions
of dollars in sales and with few exceptions the FDA follows their
recommendations.

Members of the panels are supposed to be free of conflicts of interest
relating to products they consider. But the FDA can grant a waiver if a
member's expertise is deemed to outweigh the risk of a conflict or if
the financial interest is minimal. Waivers are liberally granted all the
time.

For instance, in February 2005, when the highly publicized hearings were
held to determine whether the COX-2 inhibitors, manufactured by Merck
and Pfizer, should be permitted to remain on the market, an advisory
committee that was mired with conflicts of interest was exposed. Out of
the 32 advisers voting on the issue, ten had served as consultants to
Merck and Pfizer in recent years.

This revelation prompted Senator Mike Enzi, (R-WY), the chairman of the
Health, Education, Labor and Pensions Committee, along with Senators,
Edward Kennedy (D-MA), and Richard Durbin (D-IL), to ask the General
Accounting Office to look into the FDA's practice of letting scientists
serve on panels when they have conflicts of interest.

"We are concerned about the process that supports FDA's decisions to
waive conflicts of interest rules for scientists with financial ties to
the manufacturers of the products under consideration, or their
competitors," said a letter to the GAO, signed by Senators in September
2005.

"These practices appear to have undermined the public's faith in the
objectivity and fairness of FDA's advisory committees," they wrote. The
Senators specifically noted the conflicts among the panels that studied
the Cox-2 inhibitors like Vioxx.

According to the Associated Press on January 24, 2006, Merck currently
faces 9,200 Vioxx lawsuits, with about 4,050 in federal courts and the
rest in state courts. Without state product liability laws, drug
companies like Merck will be able to escape liability for injuries and
deaths caused by drugs like Vioxx.

The Potential of Human Papillomavirus Vaccines
The anticipated licensure within the next three months of a vaccine against human papillomavirus (HPV) would represent a major public health advance against cervical cancer and other, less common cancers, including those of the anus, penis, vagina, and vulva. The Food and Drug Administration (FDA) is conducting a six-month priority review of Merck's investigational HPV vaccine and should announce its licensing decision by June 8. Questions remain, however, about the potential behavioral consequences of routinely vaccinating adolescents against a sexually acquired infection, and the public reaction is uncertain.
Genital HPV infection is common, with an estimated 6.2 million new infections each year in the United States. Although most infections are asymptomatic and transient, persistent infection with oncogenic HPV types is a serious health issue. Cervical cancer is the 11th most common cancer among women in the United States — with an estimated 10,370 new cases and 3710 deaths in 2005. There are racial and socioeconomic disparities; more than half of all cases occur in women who have never or rarely been screened. Among women in developing countries, where effective screening programs are often lacking (see page 1110), cervical cancer is the second most common cancer, and a leading cause of cancer-related death.

The two investigational HPV vaccines are based on technology invented at the National Institutes of Health and licensed for commercial development.1,2 Merck has made a quadrivalent vaccine for use in men and women that is administered in three doses (at 0, 2, and 6 months). A key reason for vaccinating men is to prevent them from transmitting HPV to women or to other men. The vaccine is designed to protect against HPV types 16 and 18, which are responsible for an estimated 70 percent of cases of cervical, anal, and genital cancers, and HPV types 6 and 11, which cause an estimated 90 percent of cases of genital warts. The latter two types also cause an estimated 90 percent of cases of recurrent respiratory papillomatosis, a rare but debilitating disease that can occur in infants as well as adults, in which papillomas obstruct the airway; patients may require many surgical procedures to remove the obstructions.
GlaxoSmithKline is testing, for use in women, a bivalent vaccine against HPV types 16 and 18 that is also administered in three doses (at 0, 1, and 6 months). Both vaccines consist of papillomavirus-like particles, which are empty shells of viral structural proteins. They are thought to protect against HPV infection primarily by inducing the production of neutralizing antibodies, thereby preventing the development of cervical intraepithelial neoplasia — the precursor lesion of invasive cervical carcinoma — and other precancerous lesions.
HPV vaccines will not prevent infection with other sexually transmitted diseases, nor will their introduction eliminate the need for cervical-cancer screening; screening will continue to be essential to detect cancers and precancerous changes caused by other HPV types, as well as any cancer in women who have not been vaccinated or are already infected with HPV. If the vaccines' promise is fulfilled, however, they will markedly reduce the need for medical care, biopsies, and invasive procedures associated with the follow-up of abnormal Pap tests, as well as alleviating the associated anxieties and health care costs.
The pivotal efficacy and safety data for the HPV vaccines remain unpublished, and some are still being collected, particularly for the GlaxoSmithKline vaccine. Nonetheless, the data presented by the companies in public meetings of the federal Advisory Committee on Immunization Practices (ACIP) show that the vaccines have a high degree of efficacy and that the immune response is strongest in persons who are vaccinated at younger ages. The Merck vaccine has high efficacy against cervical intraepithelial neoplasia and external genital lesions in women 16 to 26 years of age, according to Lauri Markowitz of the Centers for Disease Control and Prevention (CDC), who reviewed the data for the committee. The Merck vaccine has remained effective for 2.5 to 3.5 years after a three-dose series, and it appears to be safe, the main adverse reaction being pain at the injection site.
After the companies' February presentations to the ACIP, Jon Abramson, chairman of the committee, said in an interview that he "had never before seen vaccines that in the prelicensure studies have close to 100 percent efficacy. The data are absolutely stunning." Abramson, who also chairs the department of pediatrics at the Wake Forest University School of Medicine, added: "The problem is that we don't know how long the protection will last. The worst that should happen is that a booster vaccine will be needed."
In December 2005, Merck submitted to the FDA an application for a biologics license for its HPV vaccine. The application covers the vaccination of girls and boys 9 to 15 years of age and of women 16 to 26 years of age. The FDA is expected to set the age range for the vaccine and decide whether it will be licensed for use in boys as well as girls and women. Although Merck has not revealed the price it intends to charge for a three-dose series, a company cost-effectiveness analysis assumes a cost of $300 to $500, according to a presentation to the ACIP. GlaxoSmithKline is expected to submit its licensing application to the FDA before the end of 2006.
The ACIP plays a critical role in advising the CDC and the Department of Health and Human Services about the use of vaccines, and the government usually follows its recommendations. The committee is also influential in determining which vaccines will be paid for by state and federal programs and private insurance companies.
If Merck's HPV vaccine is licensed, the ACIP will probably vote at a June meeting on whether to recommend routine vaccination at 11 to 12 years of age, in an effort to confer immunity before adolescents become sexually active. HPV infection is usually acquired soon after sexual activity begins, with a cumulative incidence of about 40 percent within 16 months. According to 2003 data from the Youth Risk Behavior Surveillance System, 7.4 percent of adolescents initiate sexual activity before 13 years of age, about one third of them by ninth grade, and about two thirds by the end of high school. If people are vaccinated before they have had sex, they should benefit irrespective of when they become sexually active.
The ACIP may also decide whether the vaccine should be recommended for older adolescents and young adults who have not been previously vaccinated and — depending on the FDA's licensing criteria — whether it should be recommended for boys as well as girls and women. Although a recommendation for routine HPV vaccination should lead to widespread use, it would be substantially different from mandating vaccination. According to Abramson, the committee is not considering the latter approach, nor does it have authority to make such recommendations. Mandating vaccination requires action by individual states.
In addition to the outcome of the FDA review, there are many unknowns about HPV vaccination. One is the duration of immunity, which will have to be determined through follow-up studies. Another is the effect on sexual behavior, which should be learned through monitoring efforts. Nonetheless, Nicole Liddon, a sociologist at the CDC, told the committee in February that it is "unlikely" that routine HPV vaccination will change adolescent sexual behavior: the initiation of sexual activity reflects many factors, including parental and community influences; fear of sexually transmitted diseases has not been a major motivation for adolescents to abstain from sex; and the availability of condoms and emergency contraception has not had measurable effects on the frequency of unsafe behavior.
The acceptance of the HPV vaccine — by physicians, parents, preteens, and the public at large — is also uncertain. As with many issues related to sex, people may have strong views. Increased acceptance is likely to require ongoing discussion and educational efforts. At the February ACIP meeting, the conservative Family Research Council, which promotes abstinence before marriage and fidelity within marriage as the best way to prevent sexually transmitted diseases, distanced itself from suggestions that it opposed HPV vaccines.3 Calling such reports "false," the council said it "would oppose any measures to legally require vaccination or to coerce parents into authorizing it" and that "there is no justification for any vaccination mandate as a condition of public school attendance. However, we do support the widespread distribution and use of vaccines against HPV."
Finally, the epidemiology of cervical cancer highlights the need to provide HPV vaccines to persons who may never or rarely be screened, as well as to improve cervical-cancer prevention programs so that they will reach the women with the highest risk of disease.4,5 The HPV vaccine is likely to be considerably more expensive than many recommended vaccines, and its benefits will not be fully apparent for decades. It will be far easier to recommend routine vaccination than to provide the resources for its routine use, in the United States and throughout the world.

Source Information
Dr. Steinbrook is a national correspondent for the Journal.

An interview with Dr. Douglas Lowy, chief of the Laboratory of Cellular Oncology at the National Cancer Institute, can be heard at www.nejm.org.
References
1. Koutsky LA, Ault KA, Wheeler CM, et al. A controlled trial of a human papillomavirus type 16 vaccine. N Engl J Med 2002;347:1645-1651. [Abstract/Full Text]
2. Harper DM, Franco EL, Wheeler C, et al. Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: a randomised controlled trial. Lancet 2004;364:1757-1765. [CrossRef][ISI][Medline]
3. Goodman E. Good news on cancer? Not for everyone. Boston Globe. November 12, 2005:A11.
4. Blumenthal PD, Gaffikin L. Cervical cancer prevention making programs more appropriate and pragmatic. JAMA 2005;294:2225-2228. [Full Text]
5. Schiffman M, Castle PE. The promise of global cervical-cancer prevention. N Engl J Med 2005;353:2101-2104. [Full Text]