Birth control drugs can cause fatal blood clots

Birth control drugs under scrutiny
Manila Bulletin
http://mb.com.ph/node/343857/birth-control-drug

WASHINGTON (AP) – Birth control drugs that were heavily promoted as having fewer side effects and the ability to clear up acne and other hormonal bothers are under new scrutiny from US safety regulators.

Research suggesting that newer birth control formulations are more likely to cause blood clots than older drugs has prompted the Food and Drug Administration to consider new safety measures in meetings later this week. The increased risk is slight, but significant because blood clots can cause heart attacks, strokes and blockages in lungs or blood vessels, which can be fatal.

Regulators could order new warning labels on several contraceptives that gained popularity in the last decade, including Bayer's pill Yaz, which was the best-selling birth control pill in the US for 2008 and 2009.

Yaz, its Bayer precursor Yasmin, and similar drugs use a version of a female hormone that appears to reduce side effects found in older drugs, including bloating and mood swings.

On Tuesday, a judge unsealed several court documents suggesting Bayer may have withheld data from the FDA about the blood clot risks of its drugs. The documents stem from expert opinion gathered by personal injury lawyers suing Bayer on behalf of patients.

Bayer AG spent more than $270 million on TV and magazine advertisements for Yaz between 2007 and 2010, according TNS Media Intelligence. Such big-budget campaigns are rare for birth control products. One advertisement featured young women singing the Twisted Sister anthem, “We're Not Gonna Take It,” while popping balloons labeled “moodiness,” “bloating” and “acne.”

Sales of Yaz have fallen since regulators forced Bayer to correct advertisements that overstated Yaz's benefits and as safety questions drew scrutiny in both the US and Europe.

FDA also is reviewing research on clot risks associated with Johnson & Johnson's weekly Ortho Evra patch, which is marketed as an “option for busy women who are looking to simplify life.” The drug uses a different version of the female hormone progestin.

Millions of women have used the products since they launched a decade ago, but recent studies comparing the medical histories of women taking the newer drugs to older ones suggest a slightly higher risk of blood clots in the legs and lungs. Last year, the US market for female contraceptive drugs totaled $3.4 billion, according to IMS Health.

Sorting out the blood clot risk of birth control drugs is especially difficult because all hormone-based drugs increase the risk of clotting. Further complicating the matter is that clots can be caused by factors such as smoking, obesity or family history.

Yaz, Yasmin and other pills containing a synthetic hormone called drospirenone are the focus of a discussion Thursday. The next day's meeting focuses on the Ortho Evra patch, which uses the hormone norelgestromin.

Bayer says its studies have shown no difference in blood clot risk between its drugs and the older birth control drugs. But several large, independent studies suggest the risk with Yaz and similar medications is slightly higher. The latest analysis by the FDA estimates the risk of a blood clot with drospirenone-containing pills is 1.5-fold higher than other hormone-based contraceptives. That translates into an estimated 10 in 10,000 women on the newer drugs experiencing a blood clot, compared with 6 in 10,000 women on older contraceptives, according to the FDA.

“It's a very small percentage of patients that develop these, but it's such a serious side effect that I think doctors have to use a lot of caution,” said Dr. Jennifer Wu, of Lenox Hill Hospital in New York.

Even if Yaz and other newer drugs get additional warning labels some doctors say they don't expect to stop prescribing them. They point out that the risk of blood clots with any birth control pill is still far lower than that associated with pregnancy and birth, when hormone levels and reduced blood flow increase clotting risk.

“At the end of the day I tell my patients the absolute risk is still very, very low compared to pregnancy and post-partum risk,” said Dr. Rebecca Starck, of Cleveland Clinic's Fairview Hospital. “There are still many benefits to combination birth control pills.”

The Ortho Evra patch already carries warning labels about an increased risk of blood clots compared with pills. Some, but not all, studies suggest patch users have twice the risk of clots. The FDA will try to further define that risk using the latest data.

Most birth control drugs use a combination of two female hormones, estrogen and progestin, to stop ovulation and help block sperm. But for decades many women have reported bloating and mood swings as side effects.

Get ready for the big move

JOHN MANGUN
OUTSIDE THE BOX  
Business Mirror
http://www.businessmirror.com.ph/home/opinion/20270-get-ready-for-the-big-move

AT a luncheon many years ago, I had the privilege of sitting across the table from Dr. Sixto K. Roxas. Dr. Roxas is a man to be listened to, as his experience is so wide. An educator, corporate executive and investment banker, this is a man who comes to the conversation with a perspective that is enviable.

Dr. Roxas studied the history of the Philippines and came to conclusion that every six years, more or less, the nation went through a tumultuous period that created far-reaching changes. Long years after our conversation, the Estrada impeachment proceedings began and eventually Gloria Macapagal-Arroyo became the President. It has been nearly 11 years since Edsa 2 and like then, the climate is turning tumultuous.

However, I have no intention of entering the conflict of discussion about separation of powers and such. There are others more qualified than I to figure out the “rights” and the “wrongs” and the implication of all the players’ actions.

I will speak, though, about the stock market.

The business headlines yesterday tell part of the reason I find stock-market trading irresistible. The Philippine Daily Inquirer said, “Philippine stocks forecast to rise” while the Philippine Star quoted opinions that, “Stocks seen listless this week.” Can both opinions be true? Absolutely. In a sense, the writers of those headlines represent the basic contrary opinions of the stock-market participants; the buyers and sellers.

As I have said so many times before, buyers buy because they believe prices will never be any lower than today. Otherwise, why buy now? Sellers believe prices will never go any higher and that is what makes for a stock market.

Do not think either, that the opinions held by the buyers and the sellers at the stock market are any less emotional and strong as the opinions held by those in the political arena. Everything is clearly black and white. For politics, it is always that opinions are either right or wrong. For the stock market, it is always that prices will go up or down. There is no gray area.

While the front pages of the newspapers talk about the tug-of-war going on in the political front, there is no less a “war” happening on the Philippine Stock Exchange between the buyers and the sellers that will determine the future of stock prices.

Buyers believe that conditions will move prices higher; sellers believe the opposite and see prices moving lower in the months ahead. Simplistically, some pundits believe that presidential power must be strongly used for the good of the country. Others are convinced that strong control of that power is most important.

Back to Dr. Sixto’s cycles. Twelve years ago the Philippine Stock-Exchange index was priced at 2,000. Now the index is well above 4,000. Sure, there have been ups and downs, with the index falling as low as 1,000 in 2003. However, the market is up over 100 percent in 12 years.

Dr. Sixto told me of minor three-year cycles also. Now it gets interesting. From 2000 to 2003, the market was down 50 percent from 2,000 to 1,000. In the next three-year cycle, the market doubled up from 1,000 back to 2,000. During the period 2006 to 2009, prices went on the roller coaster, first going higher by 75 percent and then falling all the way back down to 2006 levels in 2009. And the ride was not over. From 2009 to now, nearly in 2012, we again have witnessed the index double from 2,000 to over 4,000.

What’s the point?

The point is that the stock market is now building an incredible amount of pressure to make a large move not seen since beginning in 2000.

One column here could give you a very detailed and hopefully accurate prediction that prices are going to reach highs that are unexpected. Likewise, another could equally give you an analysis of why prices are going down, much in the same way the two newspaper headlines disagree.

There are clues all around us as to what the future will bring if we know where and how to look for them. Pagasa said a few days ago that we would have some rain this week. It was not a guess or a hunch or magical wisdom. It was a reading of the evidence in front of them. Only, they have the experience to understand and interpret the data.

If you are a stock-market investor, come by mangunonmarkets.com and subscribe to the Premium Area to get prepared.

We are soon going to see movement on the PSE that we will look back on as a monumental event.

****


E-mail to mangun@gmail.com and Twitter @mangunonmarkets. PSE stock-market information and technical analysis tools provided by CitisecOnline.com Inc.

Subdued growth

Manila Standard
Editorial
http://www.manilastandardtoday.com/sectionOpinion.htm?f=2011/december/5/editorial.isx&d=2011/december/5
 
The Aquino administration clearly missed the boat on boosting the economy this year. With nearly P300 billion in budget deficit to spare, the government did not take advantage of the leeway. The result of the underspending was evident—the economy grew just 3.2 percent in the third quarter when it could have fared much better.

The 2011 budget enacted by the Aquino administration allocated billions of funds for pump-priming activities in the hope of achieving a 5-percent to 6-percent economic growth amid the weak global environment and falling export markets. The government, instead, chose to be “cautious” and withheld spending on infrastructure projects.

The economic managers appeared to have failed to apprise President Benigno Aquino III of the severity of the global market conditions resulting from the Arab Spring, the deadly earthquake in Japan in March, and the worsening debt crisis in the Eurozone. All these unfolded in succession while the US, the world’s largest economy, struggled to create jobs and lift its gross domestic product.

The confluence of these events increased world oil prices, put Japan, the world’s third-largest economy, into deeper recession, and slowed down global expansion. Philippine exports reeled in the face of a dwindling global market, especially for electronics, and the local economy petered out.

The government, for unexplained reasons, did not bother about what was happening to the rest of the world, nor did it resort to pump-priming to counter the effects of the slowing global economy. It continued to underspend, with cement and construction companies feeling the brunt of the restrained economic activities.

Economists acknowledge that government spending is key to boosting growth. It will again be a critical factor in the coming months. Bangko Sentral Governor Amando Tetangco Jr. agreed that government spending must pick up to spur economic growth in the coming quarters.

Tetangco said while lower interest rates would increase economic activity, public expenditures were “a more effective way of generating internal growth.”

The previous administration had “front-loaded” the bulk of the deficit spending, especially in infrastructure, in the early part of the year to take advantage of the good weather conditions. There is no reason why the current administration could not do the same. The multiplier effect of pump-priming is too great to ignore.

Pro-RH rallyists get paid

No delay but RH bill won’t be passed this year—Enrile
By Christian V. Esguerra
Philippine Daily Inquirer
http://newsinfo.inquirer.net/103857/no-delay-but-rh-bill-won%E2%80%99t-be-passed-this-year%E2%80%94enrile

Are opponents of the reproductive health (RH) bill intentionally delaying the passage of the measure or are its proponents simply in a hurry?

Senate President Juan Ponce Enrile on Thursday doubted Senate Bill No. 2865 would be passed by the chamber before Congress goes on its Christmas break in two weeks.

But he made it clear that he and the other senators who had expressed reservations about the bill were not trying to delay its passage.

“I don’t think it will pass this year,” he said at the weekly Senate media forum. “There are (still) many issues to be clarified. We are not delaying it.”

Majority Leader Vicente Sotto III earlier cried foul over the allegation of Senators Pia Cayetano and Miriam Defensor-Santiago, cosponsors of SB 2865, that some senators were trying to torpedo the bill.

On Monday, Cayetano took the floor and manifested her desire to move for the termination of the period of interpellation. “There do not seem to be any other senators who have indicated their desire to interpellate,” she had said.

“I take exception to the fact that they mentioned the word ‘delay,’” Sotto said. “The last thing I would want to do is not discuss the RH bill. I want to discuss it because I want an intelligent vote from the members of the Senate. I want them to find out more about the bill, like what is happening in the House (of Representatives).”

Still in line to interpellate Cayetano and Santiago are Sotto, Enrile, Ralph Recto, Panfilo Lacson, Loren Legarda, Ramon Revilla Jr. and Lito Lapid. Lacson is the principal author of another version of the RH bill.

“We are not delaying. We still have plenty of questions… I have just started discussing the economic impact of this bill because I am concentrating on the population aspect. I have not yet dealt with the religious aspect. There is (also) a security aspect in this bill,” Enrile said.

“I would support this bill if it is only to provide health measures to womanhood. But this has an impact on our country and its future, not only in terms of health but (also) in terms of economic growth, its security and viability as a country.”

Early this year, the Reproductive Health Advocacy Network (RHAN) received P4.4 million from the United Nations Population Fund to push for the passage of the RH bill before the end of 2011. Dr. Junice Melgar, RHAN secretary general, admitted that her group solicited the amount because it “has no ongoing funding.”

Based on RHAN’s budget proposal, the amount was to be spent on activities such as “education and mobilization” program. One item worth P2,837,500 was to go to organize “two nationally coordinated (and) high-profile mobs.”

The group scheduled the “peak” of its pro-RH rally for September and set aside P1,750,000 to organize a rally of “at least 5,000 people.” Each participant was supposed to receive P350.

Enforce the sub-judice rule

By JUSTICE MANUEL R. PAMARAN
Manila Bulletin
http://www.mb.com.ph/articles/343513/enforce-subjudice-rule

MANILA, Philippines — The recent filing of the criminal case against former President and now Congresswoman Gloria Macapagal Arroyo raises several public speculation on the case as to whether it will be fairly decided.

On this score the rule of sub-judice comes to play which rule the general public may not be fully aware hence a short discussion on the matter.

Sub-judice – under or before a judge or court; under judicial consideration: undetermined (Black Law Dictionary). In plain language, it is resolving or deciding of a pending case in court. Thus, for the sake of fairness, it shall not be commented on during its pendency. Doing so, shows lack of respect for the integrity and impartiality of the court and may prejudice the right of the parties. Like any other person, the judge may succumb or be influenced by it either deliberately or unconsciously.

For this reason, courts can cite for indirect contempt any improper conduct tending, directly or indirectly, to impede, obstruct, or degrade the administration of justice (Sec. 3 (d), Rule 71 of the Rules of Court). This proper conduct may be in the form of comments on the merits of the case like innocence or guilt of the accused, the credibility of the witness or the strength or the weakness of the case of the plaintiff and the defendant of vice-versa. The aforequoted rule is considered as a valid commitment of the constitutional right of freedom of speech.

However, despite its prejudicial effect, violation of sub-judice rule proliferates because of the failure of either parties or the court to have the violators of the rule cited for contempt or they themselves violate it. And then the losing party will complain that he did not get a fair trial or decision of the case but because of other consideration. On this score, for a fair and just administration of justice with the integrity of the court held in high esteem, the court and parties themselves, including the media in all forms, most refrain from making any comment on a case pending in court. In turn, the court should strictly enforce punitive action on any violation through contempt procedures either on its own initiative or upon complaint of the offended party.

And now is the time to do it before the administration of justice degenerates to a decision of the mob, especially when it involves the former President of the country.

President Aquino needs to focus on creating jobs

Manila Times
Editorial
http://www.manilatimes.net/index.php/opinion/110-editorials/12320-president-aquino-needs-to-focus-on-creating-jobs

Many believed President Benigno “Noynoy” Aquino 3rd when he said that there would be no poverty if there were no corruption. The Filipino translation of that campaign slogan propelled the President to Malacañang. But after nearly a year and a half in office, what seems to be happening is a worsening of poverty and of the economy, even as the government tightens a “noose” around its prime target in the anti-graft campaign—former President Gloria Arroyo. Now that her case has started, we hope that the government will divert more of its attention to the economy, particularly on creating more jobs.

Palace officials seemed euphoric about Mrs. Arroyo’s arrest and trial, but the national attention was jolted back to reality by recent reports about the economy. GDP growth, a key indicator, fell to 3.6 percent, suggesting that the government will not reach its economic growth target this year. Worse, the Organization for Economic Cooperation and Development (OECD) predicted that growth in Southeast Asia would remain low until 2016, the year President Aquino finishes his term.

The dismal economic data reports were preceded by other troubling news. The number of self-rated poverty and self-rated hunger grew, plus exports fell at its fastest pace. President Aquino and others in government pin the blame on external factors. True, there are serious global problems abroad, such as the economic turmoil in Europe, the weak US economy and surging oil prices. But, as many have also pointed out, our government is partly to blame.

Repeatedly, the authorities have been criticized for underspending. One of the most vocal critics is Dr. Benjamin Diokno, an economist from the University of the Philippines. He predicted that about P100 billion allocated for infrastructure and capital outlays that would have perked up the economy would not be spent this year. But he also saw the unspent funds being carried over to 2012 and added to the P265 billion budgeted for public spending, which would be a tremendous economic boost.

President Aquino, however, needs to move more quickly, work more effectively than he has. The dry season is ideal for construction projects, but it lasts only six months in the Philippines. The President and his team would need to hit the ground running, so to speak, in 2012.

New Year’s resolutions
We hope the President changes some of his economic beliefs and working attitudes next year. For one, he and his team need to lose the penchant for doling out money to reduce poverty and invigorate the economy. Congress has already given what President Aquino wants when it approved the P1.8-trillion national budget, which includes a hefty increase in the Conditional Cash Transfer (CCT) program.

Instead of even more dole outs, creating employment should be Job No. 1 in 2012. Having more jobs addresses so many problems, not the least of which is poverty and the slow economy in general. President Aquino and his team could give the country an economic boost by simply spending the funds that he had requested from Congress.

Besides working harder and having plans with clear objectives and timetables, President Aquino needs to provide better leadership to his economic managers and others in his team. In 2012, for example, he should convene more Cabinet meetings to impress on his officials a greater sense of urgency in economic matters. President Aquino and his team not only needs to work longer and harder, but also smarter and with more determination to achieve objectives.

In defense of the President, his communications team had argued that Cabinet meetings were a waste of executive time. Besides, the team added, the President calls Cabinet clusters meetings regularly. The downward economic trends and low productive output of Malacañang and the Cabinet suggest that the laidback management style is not working. In management, the ability to get things done separates the good executives from the mediocre.

Last year, we wrote in this space that we want President Aquino to succeed. We still do, because his failures will be ours to bear. Conversely, his successes will be ours to enjoy. While many seem to be happy enough seeing the government chase after the Arroyos, we think that Filipinos would be more grateful if our leaders also focused on our other important needs—like job creation.

Contact Center Industry Accelerating Growth

Manila Bulletin
http://www.mb.com.ph/articles/343203/contact-center-industry-accelerating-growth

MANILA, Philippines — The country’s call center industry expects to grow at a faster rate of 20 to 25 percent annually in the next five years as the economic crisis in the US and Europe would put pressures on the cost of companies making outsourcing and offshoring a very attractive option for companies.

Benedict Hernandez, president of the Contact Center Association of the Philippines (CCAP), told reporters that grow would be faster than their earlier projection of 15 to 20 percent growth until 2016.

“We earlier though growth rate would be closer to 15 percent until 2016, but now it’s in the 20 to 25 percent range,” said Hernandez. This augurs well for a sustained growth over the next five years.

Hernandez said the crises in the U.S. and Europe are cost pressures on companies to cut their expenses. With the crisis, more companies are now looking at offshoring and outsourcing their non-core functions.

“The crisis puts a lot of cost pressures on these companies which may now begin to accelerate their offshoring activities

“Despite the volume of activities already, there are still a lot of these companies which have yet to outsource, both US and non-US,” he said.

This means that growth in the next five years would be a combination of expansion and new investments in the offshoring and outsourcing business.

“There is still a lot of opportunities. Companies that have not yet outrsourced would start to look at this option,” he added.

Officially, however, the CCAP is going to stick to its forecast of 15 to 20 percent growth in revenues and a net growth of 400,000 employes by end of 2011.

For this year, CCAP projects to grow its revenues by 18 percent to $ 7.1 billion employing about 406,000 compared to last year’s $6.2 billion revenues and 344,000 workforce.

He recalled that at the height of the 2008 and 2009 global financial crisis, the industry grew “significantly." (BCM)

GDP: Terrible, why?

JOHN MANGUN
OUTSIDE THE BOX
Business Mirror
http://www.businessmirror.com.ph/home/opinion/20042-gdp-terrible-why
  
ONE week ago, the title of this column was “2011: A Wasted Year.” There was some surprise in opening the e-mail Inbox and finding responses such as, “Noticed you haven’t been your usual positive self” and, “You really took a different route. No it’s not pessimistic; nonetheless you really painted a gloomy picture of 2011. So I thought I guess it was that bad for a positive person like you to write about it.”

That column was written before the third-quarter economic-activity numbers were released. There is one word to describe the Philippines’s economic performance: terrible.

The Philippines needs 4-percent gross domestic product (GDP) growth just to stay even. To register a 3.2- percent growth is to say the country is slipping. Further, the economy has been going in reverse for all of 2011 and it is not going to get any better, according to Trade Secretary Gregory L. Domingo. He believes the annual results for 2011 will be somewhere between 3.5 percent and 4 percent. Terrible.

And it gets worse.

While the GDP number was bad enough, the GNI (gross national income) growth was about five steps down from “terrible.”

GNI in the third quarter grew at 1.6 percent. In 2010, that growth was 6.9 percent. GNI measures all income, including from outside the country, from Shoemart malls in Guam to San Miguel beer operations in China.

But the secretary said he is confident the worse is over in terms of GDP growth. Ok, now I have moved in to the House of Pessimism.

In explaining the poor economic performance of the nation, Romulo A. Virola, secretary-general, NSCB, had this to say: “The so-called death spiral of debt that hounds our trading partners, the uninvigorating, albeit already expanded government spending, and the decline in fishing due to unfavorable weather and the high cost of fuel contributed to this relatively lethargic growth.”

Let me tell you about that “death spiral of debt”; it is getting worse and will continue to get worse. The European financial system is about a month or less from complete collapse. Multinational companies are drawing up contingency plans for the demise of the euro currency. The UK is making plans for potential riots and devastating social unrest. Germany cannot sell its bonds at an acceptable interest rate and Italy was forced to pay an interest rate 60-percent higher than last month. Now Europe is depending on the International Monetary Fund (IMF) for money to bail the continent out of its problems. Depending on the IMF means depending on the US. If the US is going to be the financial savior of the world, I will move to “gloom-and-doom.” I think Secretary Domingo is a little too optimistic that the worst is over for the Philippine economy.

But that optimism is not what bothers me.

The debt death spiral has been a fact for three years. The situation has been progressing from the ICU to now, perhaps, the morgue. The administration has been in charge for 18 months. Surely someone must have known that the global situation was getting progressively worse, not better. What is to be done with the Philippines’s euro holdings as the currency falls in value? Where is the presidential folder containing the government’s contingency plan against more global meltdown? I bet Ramon Ang has one on his desk for the San Miguel group.

Sec-Gen Virola was being kind in calling government spending “uninvigorating.” When government spending falls 12 percent year-on-year, uninvigorating is an understatement. A decision was made by the government last year to reduce spending to make stronger the financial condition of the government. There is nothing wrong with that idea. However, when that decision was made, did anyone look at the potential negative consequences to the economy? That is what economic planners are supposed to do. And government policy-makers are supposed to balance benefits with disadvantages.

The government experts forecast that GDP growth for 2011 would be 4.5 percent. To date it is only 3.6 percent for nine months. The government blames the global debt, the weather, and the price of crude oil for missing that prediction by so much.

All of those factors are beyond direct control. However, they always have and always will be beyond control. So what exactly is the purpose of government economic planners?

In the US, New Jersey Gov. Chris Christie said this about the failure of the Obama administration to reduce the budget deficit. “I was angry this weekend listening to the spin coming out of the administration. The President knew it was doomed for failure, so he didn’t get involved. Well then what the hell are we paying you for? What have you been doing, exactly?”




E-mail to mangun@gmail.com and Twitter @mangunonmarkets. PSE stock-market information and technical analysis tools provided by CitisecOnline.com Inc.