Mass. gov. seeks stem cell rule reversal
Fri, 30 Mar 2007 14:10:27 GMTBy GLEN JOHNSON, Associated Press Writer
CAMBRIDGE, Mass. - Democratic Gov. Deval Patrick said Friday he will push to reverse stem cell research restrictions imposed by his predecessor, Republican presidential hopeful Mitt Romney.
The changes last August prompted complaints from researchers who said they could be prohibited from using some embryonic stem cells. They also argued the restrictions undercut a 2005 law that had been approved by the Legislature over Romney's veto.
Patrick told a meeting of the Life Sciences Council on Friday that he would ask the Public Health Council, which approved the changes, to revisit the policy. In effect, Patrick will be able to reverse the policy, since he will gain control over the panel next week amid an overhaul linked to the state's new health insurance law.
"I believe that life sciences should be guided by science, not politics," Patrick told the roundtable of biotechnology officials.
The governor said researchers should not have to compete globally "under a regulatory cloud, or to do so with one-hand tied behind their back."
He said he hoped the council would create a hospitable regulatory climate "and then get out of the way so that you can do what you were trained to do, and so that your imagination and creativity can have the full range of its potential."
Embryonic stem cells have the capacity to become any cell in the body, and scientists are eager to expand their research with them to treat a variety of diseases, from Alzheimer's to diabetes. Patrick noted that his mother-in-law suffers from both, while his late mother had lupus.
Abortion opponents complain about the destruction of embryos that occurs in harvesting the cells. Romney has been heavily courting social conservatives.
Massachusetts' 2005 law banned the creation of embryos for the sole intent of donating them for research. It also clarified that district attorneys could not charge scientists for the type of research they perform.
Romney's regulations, however, stated that embryos could not be created for the sole intent of using them in research.
Patrick said reversing the Romney policy would restore the intent of the Legislature.
"That political debate happened during the debate about the legislation," Patrick said in discussing stem cells. "And then there was a vote, and the governor's previous position did not prevail in that vote. And then he re-imposed it in the regulations. That's a problem."
The new governor also reversed changes Romney had made in immigration policy and some spending cuts.
Feds start review of NIH policies
Fri, 30 Mar 2007 13:56:59 GMTBy RITA BEAMISH, Associated Press Writer
Federal health investigators are undertaking a broad review of conflict-of-interest policies at the National Institutes of Health, with potentially wide ramifications involving the agency's oversight of nonfederal scientists who conduct research with government money.
The review "will determine the extent to which the NIH oversees grantee institutions' financial conflict-of-interest issues," according to the Department of Health and Human Services' investigative branch.
Conflict-of-interest rules for NIH, the nation's premier medical research institution, do not extend to grantees outside the agency. The outside institutions are to enforce their own ethics policies and report to NIH on conflicts of interest.
HHS inspector general Daniel Levinson explained in a letter that his office is looking beyond the internal NIH ethics restrictions because most NIH research money goes to outside grantees, and the investigative office "determined that this project was an important next step in examining NIH conflict of interest."
Levinson outlined his plans in a letter to Rep. Joe Barton , R-Texas, the top Republican on the House Energy and Commerce Committee. The letter also disclosed that criminal investigators under Levinson are examining potential conflicts of interest by 103 NIH scientists who earned outside income from drug and biotech companies and were previously investigated by NIH internally.
Barton and other lawmakers have been sharply critical of how NIH polices its scientists' outside activities, even after the agency in 2005 banned its employees from the once-lucrative practice of consulting for drug companies.
Levinson's extension of his probe to grant recipients delves into an area where critics are urging public disclosure of scientists' financial ties.
"It's an area that's ripe for federal oversight," said Merill Goozner, a director at the Center for Science in the Public Interest, a private organization. "It's a pretty broad range of institutions out there and a very broad range of policies within them. Once you start working in the private sector, should you be able to come back to the government and get grants that are intermingled with those private efforts without disclosure or oversight?"
Without disclosure to the public by grant recipients, ethical conflicts easily arise, said Ned Feder, investigator for the advocacy group Project on Government Oversight.
"Many senior scientists in academia supported by NIH also have well-paid private arrangements with drug companies, arrangements that may harm their medical research," he said.
Levinson will look at whether such conflicts have affected federal and public interests.
The 103 ethics cases he is examining were investigated by NIH last year. The violations occurred in recent years when scientists were allowed to earn outside income but were required to obtain prior approval from NIH, and could not accept pay for work that overlapped their government projects.
NIH found no wrongdoing in half of the cases. It suspended six scientists for failing to get approval for outside work or report outside income. The rest got oral or written warnings.
NIH referred 10 cases to the inspector general who only investigated two, leading to one conflict-of-interest misdemeanor plea.
Now, however, Levinson has found "potential conflict of interest concerns existed" in the 103 cases, leading to the current inquiry.
"The NIH specializes in great science, not detective work, and it shows," said Barton. "I hope the inspector general's inquiry will finally sort things out so everyone can have confidence that the public's interest is being fully served."
Added Rep. John Dingell , D-Mich., chairman of the Energy and Commerce Committee, "Even if only a few of those cases result in criminal prosecution, it is clear that NIH bungled the investigation the first time around."
Spokesmen for Levinson and the NIH declined to comment.
HIV infections on the rise in Asia
Fri, 30 Mar 2007 12:13:17 GMTMANILA, Philippines - The number of people in Asia infected with the AIDS virus threatens to double over the next five years unless governments do more to stop the spread of HIV, officials said Friday.
About 8.6 million people are infected in Asia with HIV.
At the current level of inadequate response, it is expected this number will rise to about 20 million in the next five years," the independent Commission on Aids in Asia said.
The nine-member commission, funded by the Joint United Nations Program on HIV/AIDS or UNAIDS, is holding its two-day Southeast Asia Sub-Regional workshop in Manila.
It said the number of deaths currently average around 500,000 yearly, and financial losses to the Asian region are estimated at $10 billion annually. The economic cost is predicted to rise to as high as $29 billion per year if the epidemic is not controlled within the next five years.
Despite these projections, investments in HIV control in the region remain extremely low at 10 percent of the required $5 billion per year, it added.
UNAIDS data show the number of infected people receiving anti-retroviral therapy has increased more than threefold since 2003, but they represent only 16 percent of those needing the AIDS treatment.
Only Thailand is providing treatment to at least 50 percent of those in need, UNAIDS said.
Chakravarthy Rangarajan, chairman of India's economic advisory council and head of the commission, said that while the prevalence of HIV/AIDS is low in Southeast Asia, the number of infections are high because the region is populous.
He also said there was a need to mobilize domestic funds to control HIV/AIDS in the region, because more than 80 percent of funding currently comes from foreign aid organizations.
The commission said the reasons for the inadequate response in the region are manifold, ranging from low levels of awareness and understanding among policy makers to a difficulty in predicting the dynamics of the disease progression.
Sex remains taboo, with very little encouragement for sex and family education for young people. Multi-partner sex and injecting drug use, which mainly drive the epidemic, are criminal acts, resulting in infected populations remaining highly stigmatized and deprived of even limited health care services, it added.
Mexicans march to support abortion law
Fri, 30 Mar 2007 04:21:26 GMTBy CARLOS RODRIGUEZ, Associated Press Writer
MEXICO CITY - Several thousand women marched through the Mexican capital in support of a bill to legalize abortion in the first three months of pregnancy, a proposal that has drawn harsh criticism from the Roman Catholic Church.
About 3,000 protesters led by city legislators from various political parties on Thursday shouted "Freedom to choose!" and criticized President Felipe Calderon, a social conservative who has spoken out against the reform.
"A woman can decide to have an abortion or not have it, but it's her decision," said former presidential candidate Patricia Mercado, a leftist and feminist. "A secular state has the obligation to give the right to women to take this decision in the best conditions."
The bill was proposed by the leftist Democratic Revolution Party, or PRD, which holds a majority in the assembly in Mexico City — a federal district with its own legislature — and party legislators are confident it will pass in April.
PRD lawmakers also sent a bill to the federal Congress to legalize abortion nationwide, but the bill is expected to face a tougher test there, where Calderon's conservative National Action Party is the biggest force.
On Sunday, thousands of anti-abortion activists marched through the capital led by Cardinal Norberto Rivera, Mexico's most prominent cleric.
The march followed an international anti-abortion conference featuring the Vatican's top anti-abortion campaigner, Cardinal Alfonso Lopez Trujillo. The Vatican does not want to lose its fight against abortion in Mexico, which has the second-largest Catholic population in the world.
Mexico's constitution bans religious groups from political activity and the PRD has called on the authorities to stop clerical involvement in the marches.
Most Latin American countries, including Mexico, allow abortion if the woman's life is in danger or in cases of rape or incest. In November, Nicaragua passed a law banning abortion in all cases. Cuba permits abortions within the first 12 weeks of pregnancy, as does the United States.
Obesity boosts prostate cancer mortality
Thu, 29 Mar 2007 19:09:47 GMTNEW YORK - Obese men diagnosed with prostate cancer are more than twice as likely to die of the disease than their leaner peers, a new study shows.
They also have more than triple the risk that the cancer will spread beyond their prostate gland, Dr. Alan R. Kristal of Fred Hutchinson Cancer Research Center in Seattle and colleagues found.
&;These results provide yet one more important reason for men to adopt healthful patterns of diet and physical activity to achieve and maintain a normal weight,&; Kristal and his team conclude in the medical journal Cancer.
A number of studies have linked excess weight with more advanced prostate cancer, Kristal and his team note, but evidence for the effect of obesity on actual outcome from the disease has been unclear. To investigate, they looked at 752 men who had been diagnosed with prostate cancer between 1993 and 1996 and followed for an average of 9.5 years.
Men who were obese in the year before they were diagnosed with prostate cancer, meaning their body mass index was 30 or higher, were 2.6 times more likely to have died of the disease, the researchers found. They were also at 3.6 times greater risk of disease metastasis.
The data also suggested that the effect of obesity on mortality risk was stronger among men with more aggressive disease.
A clinical trial would be needed to determine if weight loss could actually help treat prostate cancer, Kristal and colleagues add.
SOURCE: Cancer, March 15, 2007.
Weekender Cialis promises China marital bliss
Thu, 29 Mar 2007 13:05:54 GMTBy Kirby Chien and Jerker Hellstrom
BEIJING/SHANGHAI - Eli Lilly & Co., maker of impotence drug Cialis, hopes that Chinese couples who might resort to traditional aphrodisiacs or divorce court to resolve sexual problems will seek marital bliss with its own remedy.
The U.S. drugmaker launched a marketing campaign for Cialis in the world's most populous country on Thursday with the release of a survey showing that 45 percent of middle-aged Chinese couples had experienced erectile dysfunction problems.
Since only one-third of those couples had thought about seeking treatment, Lilly believes that efforts to boost awareness of the problem would increase sales of Cialis, whose long-lasting effects have given it the nickname &;the weekender.&;
&;This drug is effective, because men are like light bulbs. They can be turned on and off easily. Women are like irons, they need a long time to heat up, but also a long time to cool down,&; said psychologist Qiu Xiaolan, brought in as part of Lilly's media campaign to educate the public.
Cialis, which has been distributed to 5,000 Chinese pharmacies this month, is effective for up to 36 hours, longer than rival drugs on the market, Lilly says.
&;It's a longer window of opportunity,&; Eli Lilly China President Jorg Ostertag told a news briefing.
About 35 million Chinese men suffer from some form of erectile dysfunction, Lilly said. Nearly 10 percent of these will eventually look for some sort of treatment, mainly in pharmacies.
FAMILY HARMONY
Erectile dysfunction is common among men with diabetes, high blood pressure and high cholesterol levels, and has historically been treated in China with traditional medicines containing herbs or animal parts such as tiger penis and rhinoceros horns.
&;Erectile dysfunction has become a serious issue. It not only threatens men's health, but also challenges family relationships and harmony,&; Ostertag said.
A local court in south China granted a divorce to a woman who remained a virgin after four years of marriage due to her husband's apparent sexual dysfunction, Xinhua news agency reported in October.
More than 10 percent of divorce cases center on sexual dysfunction, Xinhua ed a judge with the court in south China's Guangxi Zhuang Autonomous Region as saying.
The Supreme People's Court has ruled that sexual dysfunction that cannot be cured is proper grounds for divorce, Xinhua said.
Industry estimates for China's market for impotence drugs range from 500 million yuan to as much as 2 billion yuan a year .
Cialis, although growing faster globally than Viagra, still lags its rival, which was launched in China by Pfizer, the world's largest drugmaker, in 2000.
Levitra, an impotence drug developed jointly by Bayer AG, GlaxoSmithKline Plc and Schering-Plough Corp., is also available in China.
Pfizer does not disclose sales figures for Viagra in China but global revenues from of the drug rose 1 percent to $1.7 billion last year.
Worldwide sales of Lilly's Cialis jumped 30 percent to $971 million.
Most parents tell child that donor aided conception
Fri, 30 Mar 2007 13:39:52 GMTNEW YORK - Parents of children conceived with donor eggs or sperm don't regret disclosing this fact to their child, and almost all of the parents surveyed believed it was important that the child be told, California researchers report.
But parents do wish they had more support with the process, Dr. Robert D. Nachtigall of the University of California, San Francisco and colleagues found. &;If there is indeed a shift toward greater openness in parents using third-party reproduction techniques, there will be an increasing need for support services to assist parents in this process not only initially, but also continuing long after the children are born,&; Nachtigall and his team write in the journal Fertility and Sterility.
The researchers interviewed 141 couples, 62 of whom had conceived using donor sperm and 79 of whom had used donor eggs. Twenty percent of couples who used donor insemination had disclosed this fact to their children, 45 percent planned to disclose, 16 percent didn't plan to disclose, and 7 percent were undecided.
Among those who conceived with donor eggs, 23 percent had disclosed this to their child, 58 percent planned to do so, 10 percent didn't plan to disclose, and 9 percent had not decided.
Overall, 32 percent of parents using donor egg or sperm had disclosed to their children, while 45 percent planned to do so.
Parents who disclosed or planned to do so typically subscribed to one of two strategies for revealing this information, Nachtigall and his colleagues found: the &;seed-planting strategy,&; in which they began talking to the child about being conceived with donor egg or sperm very early on, and the &;right-time&; approach, in which they waited until they felt the child would fully understand the process.
On average, &;seed planters&; started talking to their children about their conception when they were 3 to 4 years old. The &;right time&; group had planned to begin the discussion with their children when they were 10 to 12 years old, but typically told their children when they were 6 or 7.
Parents using the &;seed-planting&; strategy tended to be more at ease with their decision and less apprehensive, the researchers found. They believed this approach would give children the sense of &;always knowing&; that they were conceived with donor egg or sperm, making it &;no big deal.&;
Parents using the &;right-time&; approach typically felt they could build a strong relationship with their children before having to disclose the information, when the child would be mature enough to handle and understand it.
&;Most parents expressed frustration with the perceived lack of comfortable language and 'scripts' available to discuss donor conception with their children, especially as they struggled to find unambiguous terminology with which to refer to the donor,&; the researchers note.
Nevertheless, among parents who had disclosed to their children, none reported regret and many reported relief, the researchers found. Responses from children were, in most cases, positive or neutral.
SOURCE: Fertility and Sterility, March 2007.
Parkinson39s drug pulled from U.S. market FDA
Fri, 30 Mar 2007 05:12:19 GMTBy Susan Heavey
WASHINGTON - U.S. health officials withdrew the Parkinson's disease drug pergolide from the market on Thursday, citing a history of safety concerns that include potentially fatal heart valve damage.
The Food and Drug Administration decided to pull the drug, first developed by Eli Lilly and Co. under the name Permax, after reports showed it can cause similar problems to the kind that triggered the withdrawal of the diet drug combination &;fen-phen.&;
The risks, when added to the fact that it was no better than other available medications, showed &;it really didn't have a place in therapy any more,&; said Dr. Robert Temple, head of the FDA's office of drug evaluation.
Pergolide is not widely used and sees between 12,000 and 25,000 prescriptions a year, Temple said. Parkinson's patients taking the drug should not immediately stop taking it, but should be switched to alternative medicines, he added.
Lilly spokesman Charlie McAtee said the company transferred U.S. ownership to Valeant Pharmaceuticals International in 2005. He added Lilly still sells the product under multiple names in other countries.
Valeant representatives could not be immediately reached for comment.
Both Par Pharmaceuticals and Teva Pharmaceutical Industries Ltd. also make generic forms of the drug. All manufacturers of the drug agreed &;the time had come&; to halt sales, Temple said.
Representatives of Par and Teva did not return calls seeking comment.
Pergolide, approved in late 1988, is a dopamine agonist usually used in combination with other medicines to help manage symptoms of Parkinson's -- a movement disorder with no cure that causes uncontrollable tremors throughout the body.
The FDA decided to pull the drug, which already carried a black box warning, after two reports published in January showed it could cause valve regurgitation. In such cases, the valves do not close tightly and the backflow of blood can lead to breathing problems, fatigue and heart palpitations.
While there were no reported deaths, Temple said, the damage can require valve replacement surgery. If not fixed, the condition can cause heart failure and sudden death.
Pfizer Inc. also makes a dopamine agonist called Dostinex, or cabergoline, that was cited for heart damage in the studies published by the New England Journal of Medicine.
While Dostinex is cleared for Parkinson's in Europe, it is only allowed on the U.S. market for the hormone and blood disorder known as hyperprolactinemia.
Higher doses needed to treat Parkinson's that would trigger the valve problems are not FDA-approved, Temple said.
Other similar drugs can cause problems, but none as severe as heart damage, he said.
&;We now have very good data that the other drugs with similar properties, other dopamine agonists, don't do this,&; Temple said. &;We didn't really have that before.&;
Other dopamine agonists include GlaxoSmithKline's Requip, or ropinirole, and Boehringer Ingelheim Pharmaceuticals, Inc.'s Mirapex, or pramipexole.
Shares of Valeant closed up 2 cents at $17.13 on the New York Stock Exchange on Thursday. Shares of Par closed up 63 cents at $25.24, also on the NYSE, while Teva shares closed up 16 cents at $36.85 on the Nasdaq. Shares in Lilly closed up 40 cents at $53.41 on the New York Stock Exchange.
Soy intake may stave off early prostate cancer
Fri, 30 Mar 2007 13:15:13 GMTNEW YORK - Consumption of the estrogen-like &;isoflavone&; substances found in soy may reduce the risk of developing early prostate cancer, but isoflavones appear to be associated with advanced disease if prostate cancer does occur, Japanese researchers report.
Isoflavones found in traditional foods that Japanese eat throughout life may be protective against prostate cancer, Dr. Norie Kurahashi told Reuters Health, but we can not recommend isoflavones from supplements to those who don't consume them regularly, &;because isoflavones may increase the risk of advanced prostate cancer.&;
Kurahashi and associates from the National Cancer Center, Tokyo, investigated the association between dietary isoflavones and risk of prostate cancer in a study of Japanese men, who generally consume large amounts of soy products and have a low rate of prostate cancer.
The study, which is reported in Cancer Epidemiology, Biomarkers & Prevention, involved some 43,500 men followed from 1995 through 2004. During that time, 307 of them were diagnosed with prostate cancer.
Consumption of isoflavones (principally genistein, but also daidzein and soy foods) was associated with a decreased risk of early prostate cancer, the authors report. Genistein and daidzein, however, were associated with an increased risk of advanced prostate cancer, the results indicate.
The protective effect of isoflavones for early prostate cancer was clearest among men over 60 years old, the researchers note, as was the association of isoflavone with an increased risk of advanced prostate cancer.
&;We suggest that isoflavones delay the progression from latent cancer to clinically significant prostate cancer in Japanese who consume isoflavones regularly throughout life,&; Kurahashi said. &;However, we do not know when or how isoflavones affect latent or prostate cancer development and whether isoflavones can be used in the treatment or...prevention of this cancer.&;
More studies are needed &;to clarify what period in life soy consumption exerts an effect against prostate cancer and what type of prostate cancer it can prevent,&; Kurahashi concluded.
SOURCE: Cancer Epidemiology, Biomarkers & Prevention, March 2007.
