California Gov Signs Controversial Vaccine Law


California Gov Signs Controversial Vaccine Law

vaccine-flickr1Following months of controversy, California Governor Jerry Brown late last week signed into law a bill that removes parental consent for vaccinating children 12 and older against sexually transmitted diseases. Although state law already allows children 12 and older to consent to treatment for sexually transmitted diseases without parental involvement, the new law expands that right to immunizations.
The bill (read here) had been strongly opposed by several organizations that argued minors do not have adequate judgment to make a decision about vaccination (back story). The legislation also figured into the wider national debate in recent weeks over HPV vaccines, concern among social conservatives about teenage sex and the extent to which drugmakers have worked to influence introduction and passage of such bills (see here andhere).
At issue is a furor that has plagued Merck and its Gardasil vaccine. The FDA approved the shot five years ago to protect girls and women ages 9 to 26 against four strains of the human papillomavirus, or HPV, which can lead to cervical cancer. Social conservatives and some parents, however, are concerned that teenagers may interpret vaccination as a green light to engage in premarital sex. Brown did not issue a statement upon signing the bill (look here), but one group is spitting mad.
“By signing AB 499 to coerce minors into risky Gardasil shots, Jerry Brown is deceptively telling preteen girls it will protect them from HPV, giving them a false sense of security that they can have all the sexual activity they want without risking developing cervical cancer or a raft of other negative consequences,” says Randy Thomasson, president of SaveCalifornia.com, in a statement.
In contrast to such sentiments, public health officials have recommended HPV vaccination – including the Cervarix vaccine sold by GlaxoSmithKline – as a useful tool to thwart the advent of cervical cancer. Nonetheless, Gardasil has been dogged by questions over side effects, cost and long-term effectiveness. Meanwhile, teenage vaccination rates for the HPV vaccine are trailing the other two vaccines recommended for teens and pre-teens, according to the Centers for Disease Control and Prevention (read here). To some extent, the concerns over Gardasil reflect the wider controversy over vaccine safety, in general.
Merck, however, fueled the debate over HPV vaccination by employing a surreptitious marketing campaign several years ago in which the drugmaker backed Women In Government, a non-profit group of state legislators, in hopes that mandatory vaccination bills for school-age children would be introduced nationwide. The effort backfired, though, and Merck ended its lobbying (back story).
But the issue re-emerged last month, when Texas Governor and Republican presidential candidate Rick Perry said his decision to sign an executive order to create a mandate. The state legislature later overturned the order, but Perry’s ties to Merck at the time became campaign fodder. These included Merck donations in the years prior to his order (read here).
The unexpected attention cast a bigger spotlight on the bill in California, where many members of the state senate and assembly who voted to approve the legislation also received money last year from Merck. This group included representative Toni Adkins, who introduced the bill and earlier this summer denied that she ever received money from the drugmaker (see here).
vaccine pic thx to lulu on flickr

FDA Panel, Bayer Birth Control Pills & Blood Clots


By Ed Silverman in Pharmalot

Nearly six months after a pair of studies found that women taking birth control pills containing a hormone called drospirenone are more likely to develop blood clots than those who take an older oral contraceptive, the FDA has decided to hold an advisory panel meeting in December to review the risks and benefits.

Meanwhile, the agency is continuing to review a separate agency-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
And so, the agency will convene the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to examine the risk of blood clots of drospirenone-containing birth control pills. The most widely known oral contraceptives containing this hormone are the Yaz and Yasmin pills sold by Bayer.
The scrutiny is not good news for Bayer. Nearly 7,000 lawsuits are pending in the US over alleged injuries and deaths relating to Yaz and Yasmin, as well as generics. The lawsuits allege Yaz and Yasmin have risks beyond those of traditional birth control pills and Bayer too aggressively promoted the pills without disclosing higher risks. Bayer was warned by the FDA in 2008 that TV ads were misleading and did not disclose added risks (see here) and recently was chastised in the UK for running a Yasmin ad that boasted the pill could prove beneficial on the same problems it may cause (read this).
As to the data, the FDA says it reviewed six published epidemiologic studies that evaluated the risk of blood clots in women using birth control pills containing drospirenone, but generated conflicting findings. Two were postmarketing studies required by the FDA or European regulators, and did not report any difference in clot risk between the pills and products containing levonorgestrel or other progestins. But two studies in 2009 reported a 1.5- to 2-fold higher risk in women who use pills containing drospirenone as opposed to contraceptives containing levonorgestrel.
More recently, two articles published in 2011 in the British Medical Journal reported a 2- to 3-fold greater risk of clots in women using oral contraceptives containing drospirenone rather than levonorgestrel. However, the FDA notes these were epidemiological studies and, so far, has not reached a conclusion on the risk for blood clots, but remains concerned about a potential increased risk (here is the FDA statement).