Thursday, August 21, 2008

NYTimes article: Drug Makers’ Push Leads to Cancer Vaccines’ Fast Rise

This article is an important read for many reasons. While it only touches the surface, it does give a basic understanding of how (award winning marketing and highly financed political and medical lobbying by Big Pharma) and why (blockbuster profits) largely untested, unnecessary and thereby dangerous drugs, are not only sold, but in this case, mandated by state governments, for mass consumption, the final phase of drug testing.

To date, according to the NYTimes article, there have been 9,749 “adverse events,” including 20 deaths. Remember, as the article says, all reports of adverse events (including deaths) are voluntary. Therefore, the actual numbers are multiples of those reported.

Article Highlights

1. Cervical cancer is rare in the US and is almost always preventable with routine PAP smears.

2. Gardasil raced through FDA approval to universal, even state mandated, use in only 6 months. Tens of millions of young girls have been vaccinated. Gardasil’s long term effects are not known. Voluntary reporting by doctors has revealed 20 deaths so far. (See my post: Who Guards Against Gardasil)

3. The vaccine offers partial protection against infection from human papillomavirus, or HPV, a common and generally benign sexually transmitted virus that can in rare cases cause cancer after years of silent infection. HPV is nearly universal and generally benign. Eighty percent of people will contract it in their lifetime and most will clear it on their own.

4. Award winning marketing, opened a lucrative new market (young girls) for vaccines and established Gardasil as the “Brand of the Year,” with projected annual sales in the US alone at $ 1.6 billion.

NYTimes: (Excerpted Article: to see the full article)

(all highlighting and emphasis in the article are mine)

August 20, 2008

The Evidence Gap

Drug Makers’ Push Leads to Cancer Vaccines’ Rise ELISABETH ROSENTHAL

In two years, cervical cancer has gone from obscure killer confined mostly to poor nations to the West’s disease of the moment.

Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries and, often, recommended for universal use among females ages 11 to 26.

One of the vaccines, Gardasil, from Merck, is made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion; proposals to mandate the vaccine for girls in middle schools have been offered in 24 states, and one will take effect in Virginia this fall.

The lightning-fast transition from newly minted vaccine to must-have injection in the United States and Europe represents a triumph of what the manufacturers call education and their critics call marketing. The vaccines, which offer some protection against infection from sexually transmitted viruses, are far more expensive than earlier vaccines against other diseases — Gardasil’s list price is $360 for the three-dose series, and the total cost is typically $400 to nearly $1,000 with markup and office visits (and often only partially covered by health insurance).

…In the United States, hundreds of doctors have been recruited and trained to give talks about Gardasil — $4,500 for a lecture — and some have made hundreds of thousands of dollars. Politicians have been lobbied and invited to receptions urging them to legislate against a global killer. And former state officials have been recruited to lobby their former colleagues.

…Merck’s vaccine was studied in clinical trials for five years, and Glaxo’s for nearly six and a half, so it is not clear how long the protection will last. …Some experts are concerned about possible side effects that become apparent only after a vaccine has been more widely tested over longer periods.

And why the sudden alarm in developed countries about cervical cancer, some experts ask. …cervical cancer is classified as very rare in the West because it is almost always preventable through regular Pap smears. …Indeed, because the vaccines prevent only 70 percent of cervical cancers, Pap smear screening must continue anyway.

…“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now,” said Dr. Diane Harper, a professor of medicine at Dartmouth Medical School.

In receiving expedited consideration from the Food and Drug Administration, Gardasil took six months from application to approval and was recommended by the C.D.C. weeks later for universal use among girls. Most vaccines take three years to get that sort of endorsement, Dr. Harper said, and then 5 to 10 more for universal acceptance. … “In that time, you learn a lot about safety and side effects and how to use it,” Dr. Harper said.

…Health economists estimate that depending on how they are used, the two cervical cancer vaccines will cost society $30,000 to $70,000, or higher, for each year of life they save in developed countries — a cost commonly seen in treating people already suffering from deadly cancers. That number will be far higher if a booster is needed.

Looked at another way, countries that pay for the vaccines will have less money available for other health needs. “This kind of money could be better used to solve so many other problems in women’s health,” said Dr. Lippman at McGill. “Some of our provinces are running out of money to provide primary care. I’m not against vaccines, but in Canada and the U.S., women are not dying in the streets of cervical cancer.”

The vaccines offer partial protection against infection from human papillomavirus, or HPV, a common and generally benign sexually transmitted virus that can in rare cases cause cancer after years of silent infection. The Merck vaccine also prevents some genital warts that are caused by other strains of the virus.

Merck last May swept the 2008 Pharmaceutical Advertising and Marketing Excellence awards, and Gardasil was named Brand of the Year by Pharma Executive Magazine….The marketing helped make Gardasil one of Merck’s best sellers, with a projected sales of $1.4 billion to $1.6 billion outside Europe this year, and more from sales in Europe…

Aggressive pharmaceutical advertising is nothing new, but the campaign was a revolution for a vaccine. Vaccines were traditionally the orphans of the pharmaceutical world because they were cheap and not particularly profitable. But the two for cervical cancer are the latest in a wave of high-priced vaccines that have come to market since 2001, opening a lucrative new field.

…In country after country, Merck and Glaxo also appealed to politicians. Vaccines, unlike antibiotics, tend to be recommended or mandated by governments. …In the United States, 41 states have passed or begun considering legislation on cervical cancer, according to the National Conference of State Legislatures, and 24 have considered proposals to mandate the vaccine for girls, generally in middle school. …The only state to pass a bill requiring the vaccine for school entry is Virginia; it takes effect in October, after school begins, so will first apply in 2009.

Merck has a growing economic interest in Virginia. In December 2006, Merck announced it would invest $57 million to expand its Elkton, Va., plant to make Gardasil, helped by a $700,000 grant from a state economic development agency that is part of the executive branch. Two months later, Gov. Tim Kaine, who has been mentioned as a possible Democratic vice presidential candidate, signed legislation requiring Gardasil for schoolgirls. Four months after that, Merck pledged to invest $193 million more in the plant to make drugs and vaccines, helped by a state grant of $1.5 million.

Delacey Skinner, a spokeswoman for the governor, said the state’s vaccination program included an unusually broad freedom to decline the shot. To exempt children from other vaccines, parents must provide a medical reason; for Gardasil, they do not. “It is a very easy step that we can take to prevent a sometimes deadly but certainly serious form of cancer,” Ms. Skinner said.

…But, as in many states where cervical cancer legislation has been considered, there have been ties between drug makers and members of government. …Early last year, Merck announced that it would no longer actively lobby for state mandates.

…Many questions about the vaccines remain unanswered, including how long immunity will last. Even commercials for Gardasil say — in small print — that “the duration of protection has not been established.”

Dr. Harper said that in the data from Merck’s clinical trials, which she helped conduct, the vaccine was no longer protective after just three years in some girls. …She said she believed that at least one booster shot, and probably more, would be needed over a lifetime.

…Other independent experts worry that eliminating the two cancer-causing HPV strains covered by Gardasil and Cervarix might allow the other cancer-causing strains of HPV to increase in frequency, reducing the vaccine’s effect

The question of side effects, however, has nagged the vaccine. …The Centers for Disease Control asks health care centers to report side effects through its Vaccine Adverse Events Reporting System; reporting is voluntary. There have been 9,749 reports, almost all from doctors and nurses, of patients experiencing adverse events after receiving the vaccine, the agency announced in a joint report with the Food and Drug Administration at the end of June. Ninety-four percent of them were not serious, ranging from arm pain to fainting, and 6 percent were classified as serious, including blood clots, paralysis and at least 20 deaths.

…Countries and consumers must decide whether it is worth preventing cervical cancer with a costly vaccine. …Where there are Pap smear programs, few women die of cervical cancer. In the United States, it is responsible for 12,000 new cases a year and 3,600 deaths, most in women who did not get Pap smears, said Laurie Markowitz, head of the HPV working group at the C.D.C. (Women with H.I.V. are predisposed to the cancer.)

Indeed, cervical cancer does not even make the American Cancer Society’s list of 10 deadliest cancers. Among American women, it causes well under a 10th of the number of deaths caused by lung cancer or breast cancer.

Though classified as a sexually transmitted disease, HPV is nearly universal and generally benign. Eighty percent of people will contract it in their lifetime and most will clear it on their own.

…Meanwhile, the vaccines’ proponents are moving to the next frontier: older women and boys. Merck recently applied for approval to market the vaccine to women 26 to 45 and is conducting studies on vaccinating boys, who can get genital warts from HPV.

One rationale for inoculating boys is that entire populations should be vaccinated to achieve what is called herd immunity. But critics ask whether it is worth conducting a campaign on the scale of the one used against polio to eliminate a generally harmless virus.

Said Dr. Raffle, the British cervical cancer specialist: “Oh, dear. If we give it to boys, then all pretense of scientific worth and cost analysis goes out the window.”

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