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May 27, 2011

Niacin Does Not Prevent Strokes or Heart Attacks

In the last decades we’ve made major strides in heart attack prevention through the use of blood pressure medications, smoking cessation, and statins – a family of cholesterol-lowering medications that have been proven to prevent heart attacks and strokes. Despite these advances, heart attacks remain the leading cause of death in the US. New medications to further decrease heart attack risk are being eagerly sought.

Allow me a brief digression to explain three important fat molecules in your blood. LDL is called “bad cholesterol” because it best predicts heart attack and stroke risk, meaning people with an elevated LDL have a higher risk of stroke and heart attack than people with normal LDL. Statins lower LDL. HDL is called “good cholesterol” because people with elevated levels have lower risk of stroke and heart attack. So low HDL is a risk factor for heart attacks. Finally, triglycerides are another fat molecule elevated levels of which predict increased risk of heart attack.

Given the enormous success of statins in lowering LDL and preventing strokes and heart attacks, hopes were high that a medication that raised HDL would have similar benefits. Niacin is known to raise HDL and lower triglycerides and has been used for many years in many patients to do just that. So the NIH decided to perform a study to measure its ability to prevent heart attacks.

The AIM-HIGH trial (All large clinical trials now have contrived, long, overly clever acronym names. You don’t want to know what AIM-HIGH stands for.) enrolled over 3,400 patients with a history of cardiovascular disease, low HDL and high triglycerides. That means they were at high risk of a future stroke or heart attack. Importantly, they all received simvastatin (Zocor) and had excellent LDL control. Half of the patients were randomized to also take extended release niacin (Niaspan) and the other half took placebo.

The patients were followed for an average of 32 months to see if the niacin group would have fewer strokes and heart attacks. As expected, the niacin group had higher HDL and lower triglycerides than the placebo group. But there was no difference in the numbers of strokes and heart attacks between the two groups. In fact, the niacin group had a tiny (but statistically significant) increase in strokes. This lack of benefit and small increase in harm led to the trial being stopped 18 months earlier than expected.

There was much wailing and lamentation, particularly at Abbott Laboratories which makes Niaspan and sold over $900 million of it last year. (Let that number roll around in your head for a minute while contemplating that the drug has no proven benefit. We skeptical evidence-based physicians who never prescribed it last year will be rewarded with an internal sense of accomplishment, a reward somewhat less tangible than $900 million.) Abbott is now in full damage-control spin mode suggesting that Niaspan may still have benefits in patients other than those enrolled in the trial. Sure. The trial was specifically designed to find a benefit by testing niacin on patients most likely to benefit – those at highest risk for heart attack and with high HDL and low triglycerides. Niacin didn’t help them, but it might help, who exactly? People with nasal allergies? People who need the Niaspan tablets to wedge under the short leg of a wobbly table?

Sadly, this isn’t the first bit of bad news in our attempts to help people by raising their HDL. A group of medicines called fenofibrates, which includes TriCor and Trilipix, also raise HDL and lower triglycerides and in recent trials have also failed to prevent heart attacks.

So what are we to make from these negative results? If low HDL is a risk factor for heart attacks, why doesn’t raising HDL decrease heart attacks? The answer is that risk factors are not causes; correlation is not causation. The fact that people who have low HDL have more frequent heart attacks than those with normal HDL doesn’t mean that the low HDL is causing the heart attacks. Some other unknown factor may cause both the HDL decline and the heart attacks, which would make HDL simply a marker of risk but with no effect on the heart attacks themselves. For example, ice cream sales in rural towns might be correlated with livestock deaths. So ice cream sales might be useful for predicting how many livestock die on a given day, but will banning ice cream lead to improved livestock longevity? No. Both the ice cream sales and the livestock deaths are caused by another factor – very hot days.

The many news articles covering this story (links below) seem not to understand this point. They state things like “lowering LDL prevents heart attacks” or “statins prevent heart attacks by lowering LDL” but we don’t know that. We have no idea how statins prevent heart attacks. We only know that they do prevent heart attacks and that they do lower LDL. There is no way to know if statins prevent heart attacks through lowering LDL or through some other mechanism. In fact, since estrogen lowers LDL and doesn’t prevent heart attacks, that suggests that LDL (like HDL) may be a marker of risk, not the cause.

So we can focus on risk factors to identify patients at risk, but for an effective treatment we must insist on a therapy that affects clinical outcomes (like strokes or heart attacks) not just risk factors. Niacin just failed that important test.

Learn more:

New York Times article: ” target=”_blank”>Boosting Good Cholesterol With Niacin Did Not Cut Heart Risks

Wall Street Journal article: UPDATE: ” target=”_blank”>NIH stops clinical trial on combination cholesterol treatment

For an explanation of the important difference between modifying risk factors and changing clinical outcomes, see my post ” target=”_blank”>More details about the CDP and niacin are in this post. The title of this post might have been somewhat more accurate if appended with “in patients taking statins”.

Important legal mumbo jumbo:
Anything you read on the web should be used to supplement, not replace, your doctor’s advice.  Anything that I write is no exception.  I’m a doctor, but I’m not your doctor despite the fact that you read or comment on my posts.

Niacin Does Not Prevent Strokes or Heart Attacks Read More »

A Farewell for Jacob Dayan

Jacob Dayan’s term as Israel Consul General of Los Angeles ends this summer—he has served away from Israel for five years, the maximum amount of time a diplomat can remain out of his country, and since late 2007 in Los Angeles—and on Friday, May 27, Los Angeles city marked his departure with a farewell celebration at City Hall.

“I’m coming here [today] knowing that the future of the state of Israel is better and stronger because there are people like you here in Los Angeles standing with the State of Israel,” Dayan, known as “Yaki” in the Jewish community, said on Friday.

“I’ve been transformed,” Dayan said, reflecting on his time in Los Angeles.

Dayan was joined at the celebration by his wife, Galit, his son, Mayor Antonio Villaraigosa and Los Angeles City Council members Paul Koretz, Dennis Zine and Eric Garcetti at a podium in the center of the council chambers.

Council members praised Dayan’s representation of Israel and his service to the city of Los Angeles—saying that he helped build bridges between the Jewish and non-Jewish communities here—and thanked him for helping nurture the United States-Israel alliance locally.

“We want to thank you for being part of our community,” Councilman Richard Alarcon said. Council members Jan Perry, Tom LaBonge, Janice Hahn, Paul Krekorian, Bernard Parks, Jose Huizar and Richard Alarcon also attended

What’s next for Dayan? He didn’t rule out the possibility that he will run for prime minister position in Israel—following Koretz’s statement, made during the celebration, that “When peace finally comes to the Middle East, you’ll be prime minister.”

“Who knows, maybe one day,” Dayan said during an interview afterwards.

Dayan said he will “continue working in the state of Israel. I haven’t decided in what capacity and how exactly, but my passion is the State of Israel, and my love is the State of Israel…So anywhere you are going to see me, the State of Israel is going to be a part of it.”

The office of the Los Angeles City Council organized the celebration, and it took place in the city council chambers and rotunda room in City Hall, lasting approximately two hours—from 9 a.m. to 11 a.m.

Both Dayan and Villaraigosa said that putting up the Israeli flag outside the consul general’s office on Wilshire Boulevard in 2008 is one of their greatest accomplishments, as the Israeli flag isn’t flown outside any other Israeli consulates in the United States.

“It was a proud moment for us—it was a proud moment for all of us,” Villaraigosa said.

During Dayan’s tenure, the consulate partnered with the mayor and city council on events and initiatives focused on increasing Los Angeles support for Israel and facilitating Jewish outreach to the broader Los Angeles community. Initiatives include the pairing of Jewish day schools, including Sinai Akiba, Stephen S. Wise Temple and Temple Emanuel, with low-performing schools in Los Angeles for cross-cultural programming in 2010; and in 2009, Dayan helped organize Fiesta Shalom, which brought together Jewish and Latino communities in Boyle Heights

Toward the close of Friday’s celebration, city council officials and the mayor presented Dayan, who was smiling throughout the event, with a Los Angeles flag and a certification of appreciation on behalf of the city.

Asked during an interview what he would miss most about Los Angeles, Dayan responded, “the people. I met amazing, wonderful people—very kind, very smart and great supporters of Israel.”

A Farewell for Jacob Dayan Read More »

Top UN official: U.S. veto would block vote on Palestinian statehood

The president of the United Nations General Assembly said Friday there is no way that a Palestinian state could become a member of the United Nations without a recommendation from the Security Council.

Joseph Deiss told a news conference that if the United States or any other permanent council member used its veto, the General Assembly would not be able to vote on membership for Palestine.

The Palestinian UN Observer Mission had no immediate comment.

Read more at Haaretz.com.

Top UN official: U.S. veto would block vote on Palestinian statehood Read More »

Thoughts on basketball and Israel

Early Sunday morning on Mothers Day, as my brother and I prepared breakfast for our mom, I also prepared myself for the special day ahead. In addition to celebrating my mom, my family would also gather in our den to watch Maccabi Tel Aviv play Greece’s Panathinaikos for the Euroleague’s Basketball Championship. Proudly wearing my Maccabi t-shirt, I thought how strange it felt that on the day we are watching Maccabi compete for the European basketball championship, that night, we would attend the Israeli Consulate’s Yom Hazikaron ceremony.

As we watched Maccabi fight valiantly on the court, unfortunately coming up short, I thought how incredible it is that a team from a small Jewish country in the Middle East was playing in the European championship for an amazing 14th time, trying to win it’s sixth championship. What is it about Israel that drives it to succeed against all odds? How does such a small country continue to achieve global success in so many fields? The answer to my question would begin at the Yom Hazikaron ceremony, and would continue throughout the week, on an emotional journey from LA to Washington, D.C.

At the Yom Hazikaron ceremony, I listened to incredible stories of courage and self-sacrifice that took place on battlefields where the stakes were much higher than a basketball championship. That night, images of Israelis battling on a basketball court were replaced with images of Israelis fighting on the Golan Heights.

The next morning, my Hebrew language teacher at YULA spent class talking about childhood friends who were killed in wars. At our school’s Yom Hazikaron ceremony, the Bnei Akiva shaliach, and my father, spoke about the painful experiences of attending military funerals. Listening to all of this, I thought how incredible it is that a society that has experienced so much pain nevertheless has the strength to move on and succeed.

The transition to Yom Ha’atzmaut helped strengthen my understanding of things. At school, in the same room where we observed Yom Hazikaron, we now celebrated Yom Ha’atzmaut with Israeli food, music, and dancing. Our school held an “Israel Talent Show,” where I sang an Israeli pop song from the 80’s called “Milim Yafot” by Gazoz. I won! It felt great to win, but this contest was more than about winning. By singing an Israeli pop song whose Hebrew lyrics are pure fun, it was my way of celebrating a society that – despite her many wars – still has the spirit to develop a cool and hip music scene.

Straight from the talent show, I rushed to the Skirball Museum for the Israeli Consulate’s Yom Ha’atzmaut reception. I arrived early for the final rehearsal of a medley of Israeli songs that I would sing together with Hedva Amrani and Noa Dori. As we took the stage, with Israeli Consul General Jacob Dayan, Mayor Antonio Villaraigosa, and 800 others watching, I looked out at the crowd and recognized so many smiling faces that were weeping just two nights earlier.  I opened the medley with the words “Ein Li Eretz Acheret” (I Have No Other Land), a song that represents a deep connection to Israel no matter what the circumstances.

From the Skirball, my father and I went to the airport and boarded a plane for Washington, D.C. Michael Oren, Israel’s Ambassador to the U.S., invited my father to attend the Israeli Embassy’s Yom Ha’atzmaut reception, and my father took me along. The reception was Thursday night, and we spent all day Thursday visiting the Holocaust Museum. We journeyed back to the dark years of Auschwitz, when anti-Semitism and genocide ruled the world. I saw what it looked like to be a homeless and defenseless Jew. I touched bunk beds from Auschwitz, walked through a train car used to transport kids my age to death camps, saw displays of hair, glasses and shoes, and looked at gruesome photos of death and destruction.

From this haunting experience, we went back to our hotel room, changed into dressy clothes, and went to the Andrew Mellon Auditorium. Located in the heart of Washington, D.C.’s national monuments, just minutes from the White House and Capitol Hill, the Mellon Auditorium would host over one thousand diplomats, military attaches, members of congress, administration officials, honored guests – and me(!) – all there to celebrate Israel’s 63rd birthday. I contemplated where I was all day, and where I stood that night, and I remarked to my father, “Who could have imagined that just sixty-six years after the end of the Holocaust, a crowd of over one thousand of some of the most powerful people in the world would gather in Washington, D.C. to celebrate a tiny Jewish state’s independence?” When Michael Oren spoke, he compared the downing of Osama Bin-Laden with Israel’s daring rescue operation in Entebbe.

With Ambassador Oren’s words, everything became crystal clear to me. Whether it’s straight out of the ashes of the Holocaust, on the battlefield defending Israel, in rescue missions to save Israelis, in humanitarian efforts in Haiti, in science labs that produce Nobel prizes, film productions that lead to Oscar nominations, in the streets of Tel Aviv, or on the basketball court, there is one character trait that Israelis share in common – persistence. It is this persistence that built the Jewish state, and it continues to drive Israelis to succeed against all odds. It is this Israeli persistence that inspires my own goals, and can serve as an inspiration to all young people my age.

While waiting on line to greet Michael Oren, my father bumped into the Greek Ambassador, who he had just met in Los Angeles a week earlier. My father congratulated him on Panathinaikos’ victory, but looked at him and said: “We’ll beat you next year.” Persistence.

Thoughts on basketball and Israel Read More »

Exclusive Footage of Bibi’s Hecklers [VIDEO]

If you’re witnessing very enthusiastic standing ovations to Bibi’s speech on May 23, it’s not only because the crowd truly appreciated and admired his words—which they obviously did. They wanted to drown out these hecklers who, out of nowhere, started chanting anti-Israel phrases throughout the speech (even as it dealt with Israeli’s achievements in finding cures for diseases. Are they anti-cures-for-cancer?).

In the video below, I was able to catch the faces of two of these hecklers, who appeared to be large middle-aged men who convulsed like raving lunatics as the security men took them out.

The second man who appears five minutes into the video sat in the press section in the back, so I got him from up close. He carried a red banner with the unintelligible: “Denial of The Nakba is Indefensible.” The Nakba refers to “The Catastrophe,” the Arab’s interpretation of Israel’s Independence Day. No rational person denies “The Nakba.” The pro-Israel community perfectly recognizes the event was a Catastrophe for many Arabs—that’s why they’re at an event like AIPAC.

Speaking informally to the Jewish Journal after the event, AIPAC’s new and dynamic spokesperson, Ari Goldberg, explained how invariably anti-Israel protesters manage to buy tickets to attend AIPAC’s gala for the purpose of interrupting the Israeli leaders. Usually, conference organizes can tell by the names and cities of origins if the attendees come for authentic purposes. In the last few years, with the rise of the internet, anti-Israel protesters secure press credentials by inventing fictitious on-line media sources. That’s how the indefensible “Nakba” guy must have entered.

In the end, the only things these hecklers interrupt and humiliate are themselves and their cause.