Friday, November 16, 2012

Should doctors add a birth control "vital sign"?

NEW YORK (Reuters Health) - An effort to develop a birth control 'vital sign' measure gets doctors to document women's use of contraception, but it doesn't make them any more likely to include family planning counseling during visits, according to a new study.

The proposed 'vital sign' consists of questions about contraception and pregnancy.

'We were hoping that this would be a prompt for much more provision of counseling by clinicians and what we saw was it only minimally affected the type of counseling that women were given,' said Dr. Eleanor Schwarz, the lead author of the study and the director of the Women's Health Services Research Unit at the University of Pittsburgh.

'We got better documentation (by doctors), but we can't say that women were better informed,' she added.

Unlike blood pressure, heart rate and other vital signs, use of birth control is not often addressed during doctor visits, Schwarz said, but it should be for women of childbearing age.

According to Schwarz's study, published in the Annals of Family Medicine, six percent of pregnancies are exposed to prescription medications that can cause a birth defect, because a large proportion of pregnancies are unplanned and birth control counseling rarely happens during physician visits.

For a year and a half, the patients of all 53 doctors in the study filled out standard intake forms. If the patient said she would like to become pregnant or wouldn't mind becoming pregnant, or if she said that she didn't want to become pregnant but isn't using birth control, the system flagged her form with a note to the doctor that said in bold text: 'Consider chance of pregnancy when prescribing.'

For a second year and a half, the patients of 26 doctors answered the pregnancy and birth control questions, while the patients of the other 27 doctors continued to fill out the regular form.

The study included about 5,300 office visits made by 2,300 women of childbearing age.

Doctors in the contraceptive vital sign group were much more likely to write down their patients' birth control method during the second half of the study when women answered the pregnancy and contraception questions than when their patients used the standard form.

During the first half of the study, these doctors documented birth control only 23 percent of the time, compared to 78 percent of the time in the second half of the study when their patients filled out the revised intake form.

Doctors whose patients did not provide the birth control vital sign information during both time periods had no change in their documenting practices - about 28 percent of visits contained information on the patient's birth control.

Despite this improvement in documentation by the doctors who received a contraceptive vital sign, there were no changes in the amount of counseling that their patients received.

Even patients who were taking medications with a birth defect warning received no more family planning advice during the time when they answered the pregnancy and birth control questions than when they filled in the standard form.

'Simply providing this information to primary care physicians doesn't seem to make a dramatic change in the rates of their provision of this counseling,' Schwarz told Reuters Health.

'Some of that may be because they have other competing clinical responsibilities and they only have so much time in a given visit and they don't have a way to bill for providing contraceptive counseling,' she suggested.

PART OF AFFORDABLE CARE ACT

Dr. Melissa Fritsche, a physician at Spartanburg Regional Medical Center in South Carolina, said that's especially true for patients who are taking medications that carry a birth defect risk.

'They often have more complex health histories and physicians often have a time crunch in terms of the number of things they can deal with in a visit,' she said.

The U.S. Affordable Care Act makes women with health insurance eligible to receive birth control and contraceptive counseling without any additional co-pays.

Although the vital sign system Schwarz developed was a good first step in getting doctors to pay attention to birth control and to write it down, Fritsche said it will be important to explore a variety of ways to get physicians to prioritize contraceptive counseling.

'I think improving and providing more education to primary care providers about contraceptive options would be also an excellent step,' she told Reuters Health.

SOURCE: http://bit.ly/PWJoWY Annals of Family Medicine, November/December 2012.



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Thursday, November 8, 2012

Watch: Los Angeles Passes Condom Mandate for Porn Industry

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Canada's supreme court strips Viagra patent from Pfizer

OTTAWA (Reuters) - Canada's Supreme Court on Thursday struck down the patent on global pharmaceuticals giant Pfizer Inc's Viagra erectile dysfunction drug and opened the door to generic competition.

The court backed an appeal by Israeli-based Teva Pharmaceutical Industries Ltd - the world's largest generic drug maker - which argued Pfizer had been too vague when filing its patent, which runs out in 2014 in Canada.

In a unanimous 7-0 verdict, the court said Pfizer had not provided enough details to identify the active ingredient in Viagra.

'Pfizer gained a benefit from the (Patent) Act - exclusive monopoly rights - while withholding disclosure in spite of its disclosure obligations under the Act,' Justice Louis LeBel wrote on behalf of the court.

'As a matter of policy and sound interpretation, patentees cannot be allowed to 'game' the system in this way ... (the patent) is invalid.'

Pfizer had previously successfully defended patent lawsuits from Teva in the United States, Spain, Norway and New Zealand.

'Pfizer expects to face generic competition in Canada shortly. The company ... is disappointed with the Court's ruling,' the firm said in a statement e-mailed to Reuters.

Company spokeswoman Christina Antoniou, citing commercial confidentiality, declined to say how much the Canadian Viagra market was worth.

Pfizer's Canadian patent - which came into force in 1998 - was divided into seven parts and covered 260 quintillion different chemical compounds.

But only one of the compounds - sildenafil - was active and the court said the patent had not provided enough information to allow another company to produce Viagra.

'Pfizer had the information needed to disclose the useful compound and chose not to release it,' said the ruling.

'Even though Pfizer knew that the effective compound was sildenafil at the time it filed the application ... it chose a method of drafting that failed clearly to set out what the invention was.'

LeBel - who said 'willful intent to mislead has not been alleged or proven in this case' - noted that Pfizer's submission to the Supreme Court had offered no explanation for withholding the information.

Teva took the case to the Supreme Court after two lower courts in Canada ruled against it. No one at the firm was immediately available for comment.

The case is 33951, Teva Canada Ltd against Pfizer Canada Inc et al.

(With additional writing by Jeffrey Hodgson; Editing by Jan Paschal and Andrew Hay)



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Canada top court rules against Pfizer in Viagra patent case

OTTAWA (Reuters) - Canada's Supreme Court on Thursday ruled against global drug giant Pfizer Inc, ruling that a patent on its Viagra erectile dysfunction drug was no longer valid.

The court backed an appeal by Israeli-based Teva Pharmaceutical Industries Ltd - the world's largest generic drug maker - which argued Pfizer had not provided enough details when filing its patent, which runs out in 2014 in Canada. (Reporting by David Ljunggren; Editing by Jeffrey Hodgson)



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Wednesday, November 7, 2012

Los Angeles mandates condoms for porn actors, industry threatens suit

LOS ANGELES (Reuters) - Los Angeles County voters passed a ballot initiative mandating that pornographic film actors wear condoms during sex scenes, prompting a trade group on Wednesday to threaten to sue and take production elsewhere.

Measure B, which was sponsored by the group AIDS Healthcare Foundation, won approval on Tuesday by a margin of 55.85 percent to 44.15 percent, according to the Los Angeles County Registrar-Recorder's office.

'This is what democracy looks like; we took this to county government, and they didn't act so we took it directly to the voters, and they spoke conclusively,' AIDS Healthcare Foundation President Michael Weinstein said.

The law requires adult film actors filming in Los Angeles County to use condoms during sex scenes. Most U.S. pornographic productions are made in the county's San Fernando Valley.

Diane Duke, chief executive for the industry group Free Speech Coalition, told Los Angeles County supervisors in a letter on Wednesday that the law was unconstitutional and that it fell under state jurisdiction, not that of local government.

'Therefore, we will file suit and challenge this intolerable law in court,' Duke said in the letter. A copy was provided to Reuters.

She said the adult filmmakers had been approached to move elsewhere, adding: 'In the upcoming weeks and months, we will provide a roadmap for adult production to move its over a billion dollar industry and its accompanying 10,000 jobs to these welcoming communities.'

David Sommers, a spokesman for the Board of Supervisors, declined to respond specifically to the letter, saying he had not read it. He said county health officials were still grappling with the law's implications.

'This type of enforcement is a new thing for us and it's a one-of-a-kind law and so how we move forward with its implementation is a conversation we're just beginning to have given how the voters decided Measure B,' he said.

The initiative requires porn producers to get a health permit from Los Angeles County to make their movies showing explicit sex and nudity. Using condoms on set would be a condition of obtaining that permit.

California workplace laws mandate the use of condoms by porn performers, but AIDS Healthcare officials say the statute is not specifically aimed at the industry and is widely violated.

The Free Speech Coalition said in its letter that such requirements would impose 'excessive costs of compliance.'

(Reporting by Dan Whitcomb; Editing by Cynthia Osterman)



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LA County voters mandate condom use on porn sets

LOS ANGELES (AP) - Los Angeles County voters have approved a measure requiring porn performers to wear condoms while filming sex scenes, prompting a pledge by the adult entertainment industry to sue to overturn the measure.

With 100 percent of the county's precincts reporting, Measure B passed 56 percent to 44 percent in Tuesday's election.

The measure requires adult film producers to apply for a permit from the county Department of Public Health to shoot sex scenes. Permit fees will finance periodic inspections of film sets to enforce compliance.

The AIDS Healthcare Foundation, which sponsored the initiative, says the measure will help safeguard the public, as well as porn workers, from sexually transmitted infections.

But the adult film industry, which is largely centered in the San Fernando Valley in suburban Los Angeles, says the requirement is unnecessary since the industry already polices itself by requiring performers to undergo monthly tests for HIV and other infections.

The industry also says porn viewers will not watch sex scenes with condoms, forcing adult film producers to relocate to where they can make movies that will sell.

On Wednesday, the Free Speech Coalition, a trade group representing the adult entertainment industry, said it plans to file a lawsuit to overturn the condom requirement on constitutional grounds.

'We believe in the calm, serious deliberations of the legal system, we will find that Measure B is in fact unconstitutional,' Diane Duke, the coalition's executive director, said in a statement. 'The adult film industry will not just stand by and let it destroy our business.'

In a letter sent to the county Board of Supervisors, the industry also requested that it be involved in discussions as to how the county will implement the requirements. It will also explore moves to neighboring states as soon as possible, the coalition said.

'While the AIDS Healthcare Foundation has tried to portray any move of jobs outside of L.A. County as unrealistic, the hard truth of the matter is that is exactly what this industry plans on doing now,' said James Lee, communications director for the No on Government Waste Committee, which opposed the measure.

Michael Weinstein, president of the AIDS Healthcare Foundation, said he is not fazed by threats of a lawsuit or of relocation. The issue is one of public health and safety for workers who run a high risk for sexually transmitted illnesses, he said.

The industry argument did not convince voters, he said. 'There was a very high degree of awareness about this proposition,' he said. 'Voters were educated about it.'

About 200 companies produce adult films in Los Angeles. A two-year health permit would cost about $11,000, comparable to permits for tattoo and massage parlors, Weinstein said.

'We don't want one more person to get HIV,' he said.

___

Contact the reporter at http://twitter.com/ChristinaHoag .



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Thursday, November 1, 2012

Judge backs Catholic firm over contraception mandate

(Reuters) - A Catholic-owned family business in Michigan does not have to comply with the provision of the new U.S. healthcare law that requires private employers to provide employees with health insurance that covers birth control, a federal judge in Detroit has ruled.

U.S. District Judge Robert Cleland, in a ruling late Wednesday, temporarily blocked the government from forcing the owner of Weingartz Supply Company, which sells outdoor power equipment, to include contraception in its health coverage of employees.

The ruling only affects the company's Catholic proprietor, Daniel Weingartz, and the approximately 170 people who work for him. But it opens the door for other firms to seek relief on religious grounds.

Cleland is now the second federal judge to temporarily block part of the Affordable Care Act of 2010 from being enforced against the religious owners of a family business. In July, U.S. District Judge John Kane in Denver temporarily prevented the government from requiring the Catholic owners of Hercules Industries Inc, a private manufacturer of heating, ventilation and air conditioning equipment, to provide health insurance that covers birth control.

Weingartz was joined in his lawsuit, filed in May, by Legatus, a national association of Catholic business owners.

Roman Catholic bishops and many Republican lawmakers have opposed the birth control provision, and priests have been speaking out against the law from pulpits across the country. Church doctrine opposes artificial contraception but most American Catholics do not adhere to church policy.

Lawyers for the Department of Health and Human Services argued that granting exceptions for small business owners would interfere with the government's ability to implement the law. The contraception mandate serves the government's interests in promoting public health and gender equality, they argued.

The federal government has carved out an exemption from the contraception requirement for religious organizations. Allowing additional relief for Weingartz Supply Co and its 170 employees would not be a much greater burden, the company argued. Cleland agreed with Weingartz.

'The harm in delaying the implementation of a statute that may later be deemed constitutional must yield to the risk presented here of substantially infringing the sincere exercise of religious beliefs,' Cleland wrote in a 29-page opinion.

The judge refused to shield Legatus from the law, finding that the non-profit association would likely qualify for the government's accommodation for religious organizations. If the government later tries to enforce the mandate against Legatus, the group can resume its court challenge then, Cleland wrote.

Erin Mersino, an attorney with the Thomas More Law Center, which filed the challenge, called the ruling 'not only a victory for our clients, but for religious freedom.'

The Department of Health and Human Services did not immediately respond to a request for comment.

More than 20 lawsuits have been filed against the birth control mandate by organizations including the University of Notre Dame, Catholic University of America and the Archdiocese of New York.

In July, another federal judge in Nebraska dismissed a similar lawsuit brought by seven states, two Catholic individuals and three Catholic non-profit institutions, finding that the plaintiffs did not face any immediate harm from the law.

The case in U.S. District Court for the Eastern District of Michigan is Legatus et al v. Sebelius et al, No. 12-12061.

(Reporting By Terry Baynes in New York; Editing by Claudia Parsons)



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