News (Updated December 17,
2006)
[Home]
[Previous
news]
By Will DunhamWed Dec 13, 3:59 PM ET
Circumcising men cuts their risk of being infected with the AIDS virus in half, and could prevent hundreds of thousands or even millions of new infections, researchers said on Wednesday.
Circumcising men worked so well that the researchers stopped two large clinical trials in Kenya and Uganda to announce the results, although they cautioned that the procedure does not make men immune to the virus.
Public health leaders hailed the results as pointing to a potentially powerful way to reduce HIV infections in Africa, the continent hardest hit by AIDS.
"It does have the potential to prevent many tens of thousands, many hundreds of thousands and perhaps millions of infections over coming years," Dr. Kevin De Cock, director of the World Health Organization's Department of HIV/AIDS, told reporters.
A U.S. National Institutes of Health study in Kisumu, Kenya, involving 2,784 men aged 18 to 24 showed a 53 percent reduction of HIV infections in circumcised men compared to uncircumcised men. A parallel study involving 4,996 men aged 15 to 49 in Rakai, Uganda, showed circumcised men were 48 percent less likely than uncircumcised men to become infected.
Researchers previously had noticed that in places where circumcision is common, HIV was less common.
Results of the first major study on the issue were reported last year out of South Africa, with researchers seeing a 60 percent reduction in HIV risk for circumcised men. Researchers viewed the new trials as strong confirmation.
Dr. Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, said the institute ended both trials early and offered circumcision to all men involved in them. The trials began in 2005 and were due to go until mid-2007.
HIV PREVENTION
"These results indicate that adult male circumcision could be an important addition to an HIV prevention strategy for men. Male circumcision can lower both an individual's risk of infection and hopefully the rate of HIV spread through the community," Fauci said.
Experts say the prevalence of male circumcision varies by region in African countries south of the Sahara, with large numbers of men in some areas remaining uncircumcised.
Fauci said while the initial circumcision benefits would be fewer HIV infections in men, the practice could lead to fewer women getting infected in parts of the world like Africa where the virus is passed largely through sex between a man and woman, not homosexual sex.
Another study is underway in Uganda assessing HIV infection risk for women with circumcised partners.
Experts say the reduced HIV risk may be because cells on the inside of the foreskin, the part of the penis cut off in circumcision, are particularly susceptible to HIV infection. HIV also may survive better in a warm, wet environment like that found beneath a foreskin.
Fauci said circumcision is not completely protective "and must be seen as a powerful addition to, not a replacement for, other HIV prevention methods." Fauci said the benefits could be negated by small decreases in condom use by men or if men add more sexual partners.
"These results only apply to men where the risk of HIV transmission is through the penis. Transmission by injection drug use or receptive anal intercourse will not be affected by adult male circumcision," Fauci added.
De Cock said public health experts might encounter cultural and social barriers in parts of Africa to male circumcision.
Of the 39.5 million people worldwide infected with the human immunodeficiency virus, 24.7 million are in sub-Saharan Africa. About 25 million people have died from AIDS since it was first identified a quarter century ago.
By Ransdell Pierson and Lewis KrauskopfTue Dec 12, 4:49 PM ET
Merck & Co. (NYSE:MRK - news) expects to seek U.S. approval in 2007 for drugs to treat HIV, cholesterol and insomnia, and it aims to have another four products in late-stage trials by mid-year, the company said on Tuesday.
The products due to be in late-stage trials are MK-524B, which raises "good" HDL cholesterol; weight loss drug MK-364, which works through the same mechanism as Sanofi-Aventis' (SASY.PA) Acomplia; MK-974 for migraine headaches; and MK-822, which treats osteoporosis by blocking a protein called Cathepsin K.
Merck also reviewed its drugs in earlier-stage trials, as the company aims to restore double-digit earnings growth by 2010 following recent patent expirations on older medicines and the withdrawal two years ago of its Vioxx arthritis treatment.
The U.S. drugmaker laid out its plans in a meeting with investors, but Merck shares slipped about 1 percent amid a perceived lack of excitement at the annual event.
"There really wasn't much surprise," Natexis Bleichroeder analyst Jon LeCroy said of the main portion of the meeting on drug research. "It's a relatively uneventful meeting."
OrbiMed Advisors analyst Trevor Polischuk said he took a "negative" overall view of the presentations on Merck's experimental drugs because side effects or disadvantages were seen among many of them.
"Every sort of compound you can come up with has some negative baggage," Polischuk said, referring to highlighted Merck drugs.
For example, Polischuk said Merck predicted its insomnia drug, gaboxadol, would be a controlled substance because of its abuse potential, eliminating a potential advantage over rival drugs.
Merck research chief Peter Kim said one of the company's most promising experimental drugs is its HIV medicine MK-518, which blocks an enzyme called integrase. It works faster than perhaps any other class of medicines to reduce HIV levels, he said.
"The speed in knocking down HIV ... and its ability to inhibit (drug) resistant HIV is very impressive," Kim said at the meeting, held at company headquarters in Whitehouse Station, New Jersey.
Kim also put the spotlight on MK-364, but noted the weight-loss drug was linked to psychiatric side effects in clinical trials. He noted that Sanofi's Acomplia had been associated with depression in its own trials.
The research chief expressed enthusiasm for MK-859, another Merck HDL-raising drugs, which works the same way as Pfizer Inc.'s (NYSE:PFE - news) torcetrapib, for which trials were halted early this month on safety concerns.
He said MK-859 raised levels of HDL by more than half in trials and cut levels of "bad" LDL cholesterol by more than 20 percent, without raising blood pressure or causing serious cardiovascular side effects.
Torcetrapib, by contrast, was discontinued after being linked to elevated blood pressure and a worrisome number of deaths.
Merck also singled out cancer drug, MK-457, now in mid-stage trials against a wide variety of tumors, which blocks a protein called Aurora kinase.
Merck, which last week maintained its forecast for flat 2006 earnings and slightly higher 2007 results, largely pegged its financial goals to revenue from three recently launched new vaccines and a new diabetes drug called Januvia.
Company officials also stressed the importance of a continuing restructuring plan meant to produce cumulative savings of up to $5 billion from 2006 through 2010.
"Fundamentally rebuilding our business model will lead us to a place where other companies will (need) years to catch up with us," Peter Loescher, Merck's president of global human health, said after the meeting.
Shares of Merck closed down 39 cents to $43.62 on the New York Stock Exchange.
(Recasts; adds FDA comments, byline; edits)
By Susan Heavey
WASHINGTON, Dec 11 (Reuters) - More patients with serious diseases could get experimental drugs under revised rules proposed on Monday by the U.S. Food and Drug Administration that also detail how manufacturers can charge for them.
The FDA said the changes spell out more clearly which patients are eligible for special access to the unapproved products, as well as the fees they may have to pay.
"When people are dying of a disease and they've run out of therapies, not everyone wants to take an investigational drug under those circumstances. But some people definitely want to take that risk and we want to give them that choice," Dr. Janet Woodcock, FDA's deputy commissioner for operations, told reporters.
Experimental, unapproved medicines have been available to some patients under certain circumstances since the 1970s, the agency said. In the past, thousands of patients with HIV and AIDS, cancer and heart problems have been able to use some drugs prior to approval.
But Woodcock said the current confusion about the regulations made them "one of the best kept secrets around" for needy patients. She could not estimate how many more people might now seek experimental drugs but said the new details should help.
Patient groups have long been pushing for the FDA to expand access for desperate patients.
In 2003, two advocacy groups sued the FDA seeking patient access to new cancer drugs that were shown to be safe in initial tests but had not yet received approval. The case was sent back to lower courts for review in May.
The new rules, which are open for 90 days of public comment, detail access for small groups of patients as well as individuals with serious but not immediately life-threatening conditions, the FDA said. It also clarifies how companies should calculate their fees.
Under the proposal, companies could charge consumers for what it cost in materials and labor to make the medicine as well as shipping, handling and other administrative expenses, the FDA said. Patients participating in clinical trials also could have to pay.
Woodcock said the rules aimed to help academic researchers and small companies offer experimental drugs when they otherwise could not by allowing them to recoup their costs. Larger drugmakers usually do not charge patients and the FDA expects that to continue, she said.
Current, vague rules kept many manufacturers from helping such needy patients, she said, adding the revisions have "nothing to do with profits" and will be strictly monitored.
She also cautioned against company attempts to commercialize their products with such early use, adding they are expected to participate while continuing to develop them for future regulatory approval.
Woodcock would not comment on how the new rules could impact the pending
lawsuit. Representatives for the Abigail Alliance, one of the groups that filed
the suit, could not be immediately reached for comment.
The AIDS Healthcare Foundation will begin its campaign this Wednesday by taking out a full-page ad in the Village Voice, an alternative weekly in New York. The ad will also appear this week in LA Weekly and The New York Blade, a weekly newspaper for the gay and lesbian community.
Ads will also eventually be placed in publications in South Florida and San Francisco, according to the Foundation which provides health care to AIDS patients as well as education and prevention advice about the disease.
The ads show a picture of a prescription pad which contains the message that Viagra combined with crystal methamphetamine creates a prescription for HIV infection. It says that crystal methamphetamine makes it difficult to get and keep an erection, but Viagra makes it possible to maintain an erection while on the illegal drug.
Lori Yeghiayan, a spokeswoman for the Foundation, said that Pfizer's marketing treats Viagra as a tool to improve one's sex life instead of a drug for a medical condition.
In a statement, Pfizer said that it has always been committed to safe and appropriate use of Viagra and that the product's label clearly states that it does not protect against sexually transmitted diseases.
Tue Dec 12, 8:02 PM ET
There are strong scientific reasons for British scientists to continue research using monkeys in "carefully selected research problems," especially when it is the only way to save human lives, a committee of experts said Tuesday.
"There is a strong scientific case for maintaining work on non-human primates for carefully selected research problems ... at least for the foreseeable future," the Weatherall Report said.
Animal testing causes great controversy in Britain and animal rights groups have attacked companies and individuals involved in research on animals. Each year, around 3,300 monkeys are used in scientific or medical research in Britain, about 0.1 percent of all animals used in laboratory experiments in the country.
Three-quarters of animals used in testing are involved in testing the safety of new medicines.
Experiments on great apes, such as chimpanzees and gorillas, are expressly forbidden in Britain, although smaller monkeys may be used.
But critics say even smaller primates are sufficiently sentient to experience great suffering.
The committee, chaired by Oxford geneticist Sir David Weatherall, accepted that there are some cases where the availability of other scientific approaches weakens the argument in favor of using monkeys.
It said it was important only to experiment on the primates in order to answer questions about the immune, nervous and reproductive systems that cannot be answered using rodents and other animals which are too unlike humans.
The committee also said research on monkeys currently provides the only way of ensuring the safety and effectiveness of vaccines for HIV and other infections, and treatments for brain diseases, such as Alzheimer's or Parkinson's.
Weatherall said there is funding available for only about 10 major HIV, tuberculosis and malaria vaccine trials over the next 10 years. These trials could take five years and involve 10,000 volunteers, he said.
Testing "in a small number of non-human primates can ensure we only proceed into human trials with vaccines that are likely to prevent millions of people dying of these diseases," he added.
The company this year launched five new vaccines and medicines, all well received, without expanding its sales force, Clark told analysts at Merck's annual business briefing at headquarters in Whitehouse Station, N.J.
Merck is speeding up the time it takes to get experimental drugs through testing and onto the market, which boosts revenues by giving those drugs more years on sale without generic competition. This year's launch of diabetes drug Januvia, for example, was about four years earlier than under a traditional development schedule.
Merck said it is ahead of schedule in some areas of its effort to cut costs by $4.5 billion to $5 billion through 2010, including reducing supply chain costs by $1 billion.
The company has completed 3,900 of 7,000 planned job cuts, closed or sold three of the five manufacturing plants slated for elimination and retooled its manufacturing network, Clark said.
"We are on our way to becoming a high-performance organization," Clark said, adding, "We still have much to do to truly transform Merck."
Clark said eight potential products are on the horizon: three under review by U.S. regulators, three ready to be submitted for regulatory review and two others well into the final phase of human testing.
However, analyst Steve Brozak of WBB Securities said he's not convinced any of those new drugs will be a blockbuster, adding he is disappointed Merck isn't consummating more partnerships to acquire promising drug candidates.
"It was a big yawn," Brozak said of the briefing, adding Wall Street confirmed his reaction because Merck stock didn't move up.
Shares fell 39 cents to close at $43.62 in trading on the New York Stock Exchange.
Peter S. Kim, president of Merck Research Laboratories, said the company expects the Food and Drug Administration this year to decide whether to approve painkiller Arcoxia, the successor drug to withdrawn blockbuster Vioxx, and Janumet, which combines Merck's Januvia with an older diabetes treatment called metformin. FDA also is to rule on an intravenous version of Merck's antinausea pill Emend.
Merck expects next year to file for FDA approval for a new type of HIV drug, an insomnia treatment and a niacin-based drug that raises good cholesterol, Kim said. Following those drugs are four others in final human testing: another cholesterol drug that combines the niacin-based one with Zocor, which had been Merck's No. 1 drug until generic competition began in June; a weight-loss drug, a migraine treatment and an osteoporosis drug.
Kim also noted two other promising drugs in mid-stage testing, one for cancer and the other a cholesterol drug from the same class as torcetrapib. That's the highly anticipated drug for which rival Pfizer halted development this month due to unexpected heart problems and deaths among patients.
"No cardiovascular events were observed" in mid-stage testing, and the drug increased good cholesterol by more than 50 percent and decreased bad cholesterol about 20 percent, Kim said.
But analyst Tony Butler of Lehman Brothers wrote in a research report that the concerns raised by the Pfizer drug show long-term studies are needed on the Merck drug, still known as MK-0859.
Merck disclosed that it now faces about 27,200 personal injury lawsuits over Vioxx, some representing multiple plaintiffs, plus 265 potential class-action suits. The company pulled the former blockbuster from the market on Sept. 30, 2004, after its own research showed Vioxx doubled the risk of heart attacks and strokes. Another 14,000 plaintiffs have entered agreements with Merck suspending the time limit for lawsuits.
So far, Merck has reserved nearly $1.6 billion for its legal defense costs.
Merck also reaffirmed the 2006 profit forecast it gave last week: from $2.18 to $2.25 per share, or $2.48 to $2.52 excluding charges for the ongoing restructuring program. Next year, the company expects higher earnings per share, between $2.36 and $2.49 per share, or $2.51 to $2.59 excluding restructuring charges.
"We believe FY07 guidance was conservative," wrote Butler at Lehman Brothers, which does business with Merck. "In a bullish scenario, (earnings per share) could be as much as $2.70."