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Thursday, June 11, 2015

Health Care Reform Articles - June 11, 201

Why Are The 2016 Obamacare Rate Increases So Large?

GUEST POST WRITTEN BYRobert Laszewski
You might recall that I have said we wouldn’t see the real Obamacare rates until the 2017 prices are published in mid-2016. By then health plans will finally have had a couple of years of credible claim data and two of the three “3 Rs” reinsurance provisions subsidizing the insurance companies will have gone away.
I have also made the argument that after two years the Obamacare enrollment is coming up way short of what it needs for us to be assured that we have a sustainable risk pool—enough healthy people signed up to pay the costs for the sick.
Instead of moderate rate increases for one more year, the big rate increases have begun. They are particularly large among the health insurers with the most enrollment—the carriers with the most data.
Texas Blue Cross stands out. The health plan commented in its federal government rate filings that it covered 730,833 Obamacare individuals in 2014 with premium of $2.1 billion and claims totaling $2.5 billion––for a medical loss ratio of 119%. The plan further commented that, after the “3Rs” reinsurance adjustments, they lost 17% to 20% of premium in 2014–that would be about $400 million. And, they are only asking for a 20% rate increase.
While we won’t see all of the rates in all of the states for a few months, some state regulators have begun to make the 2016 rate actions public:
• CareFirst Blue Cross of Maryland is asking for a 34% rate increase on its PPO plan and a 26.7% rate increase for its HMO. CareFirst has an 80% market share in the Obamacare exchange and only 30% of the eligible Maryland market has signed up on the exchange.
• In Oregon, where less than 35% of the eligible have signed up on the exchange, the biggest insurer with 52% of the market, Moda, has asked for a 25.6% increase. Lifewise, with a 19% market share, has asked for a 38.5% increase.
• Blue Cross Blue Shield of Tennessee, with a 165,000 members making up 70% of the Obamacare exchange is asking for a 36.3% increase. The second biggest player, Humana HUM +0.93%, is asking for a 15.8% increase. Less than 40% of the eligible exchange market signed up in Tennessee.
• Georgia is the second biggest Obamacare market for Humana, having enrolled 254,000 people out of a total market of 479,000, and Georgia “maybe its biggest misstep”. Its CEO has said about Georgia, “We can’t have one business being subsidized by another business.” Humana is asking for 2016 individual plan rate increases from 14.8% to 19.44%.
• In Iowa, with the lowest enrollment rates in the country, and where its biggest Obamacare insurer went broke last December, Wellmark Blue Cross, which only sells off the exchange, is asking for a 43% increase on its Obamacare compliant policies. Coventry, which has 47,000 Obamacare customers, is asking for an 18% increase for its on-exchange business.
• The Kansas insurance department has not made its rate increases public yet but has said that plans will increase by as much as 38%. Less than 40% of the eligible have so far enrolled.
• Pennsylvania is not encouraging with market leader Highmark asking for increases ranging from 13.5% to 39.65% and the Geisinger HMO asking for increases from 40.6% to 58.4%. Pennsylvania enrolled 50% of the potential exchange market in 2015. 

Panel Tells F.D.A. to Back Second Drug to Help Heart 

By 
An expert committee that advises the Food and Drug Administration recommended on Wednesday that the agency approve the second in a new class of drugs that can drive cholesterol levels down to unheard-of levels.
Cardiologists hope these new medicines will help prevent heart attacks for millions of Americans, but the results of the clinical trials that will definitively settle the question of the drugs’ effectiveness will not be in until 2017.
The panel on Tuesday had advised the F.D.A. to approve the first such drug, alirocumab, made by Sanofi and Regeneron Pharmaceuticals, and on Wednesday recommended approval for the second, a similar drug, evolocumab, made by Amgen. The agency usually follows the advice of its expert committees.
Based on the drastic reductions of so-called bad LDL cholesterol levels and the lack of evidence so far of safety concerns, the panel decided that the drugs would fill a critical unmet need for people at high risk of heart attacks who are unable to get their cholesterol under sufficient control with statins, the mainstay drugs to lower cholesterol that came on the market in the late 1980s.
Studies have consistently found that elevated levels of LDL cholesterol are a major risk factor for heart disease and that risk drops in lock step with declines in LDL.
If the F.D.A. approves the drugs, they are expected to change the landscape for heart attack prevention and become blockbusters for the companies that make them.
The committee unanimously agreed that Amgen’s drug should be approved for people with a rare genetic disorder, homozygous familial hypercholesterolemia, because of their dire need for treatments. They have LDL levels that can soar as high as five times the normal level and they die young from heart attacks.
The panel voted 11 to 4 in favor of making the drug available to other groups of at-risk patients for whom statins do not work well.
Dr. Philip Sager of Stanford said he thought it was “more likely than not” that the drugs would be safe and effective.
“I do acknowledge the uncertainty,” Dr. Sager said, “I am unwilling to wait until 2017 or 2018 to get those results.”
Those who voted no stressed the paucity of safety data.
“I think we need longer exposures to this new product,” said Dr. Peter Wilson of Emory University.


On Capitol Hill, one giant Obamacare fight

Rep. Paul Ryan (R-Wis.), chairman of the House Ways and Means Committee, wanted to know whether President Obama is going to work with Congress to rewrite health-care law if the Supreme Court strikes down Obamacare — “or is he going to put concrete around his ankles and say, ‘It’s my law or nothing’?”
This gave the panel’s ranking Democrat, Rep. Sander Levin of Michigan, a toehold. “You talk about concrete, having feet in concrete,” he responded. “That’s exactly where you’ve been” on the Affordable Care Act. “Your feet have been in concrete while you have brought up bill after bill to try to destroy ACA.” 
Proposed Levin, “The shoe should really be on the other foot.”
Maybe both of them should put a sock in it. 
Wednesday’s hearing, coming as the nation awaits word on whether the Supreme Court will strike down the law that defines the Obama presidency, was less a legislative forum than a pageant of ankle-biting. 
Ryan accused the Obama administration of “acting like a purse snatcher” and rolled out an assortment of invective: “The law is on the fritz. . . . Obamacare is just flat busted. . . . The whole law is a lemon.”
Retorted Levin: “What’s busted is not ACA but your attacks on it, endless attacks, never coming up with a single comprehensive alternative all these years. . . .You’re livid because it’s getting better. . . . Your frustration is millions and millions and millions of people are benefiting.”
With that tone set, the rank and file followed. “Why does the administration choose to trample on the Constitution?” Rep. Charles Boustany (R-La.) wanted to know. 
Rep. Jim McDermott (D-Wash.) proclaimed that states such as Alabama and Georgia “clearly don’t care about the level of health care” — which prompted Rep. Tom Price, a Georgia Republican, to interrupt with a request that McDermott “take back the disparagement of the citizens of Georgia.”
Rep. Sam Johnson (R-Tex.) couldn’t even bring himself to utter the usual pleasantries to the witness, Health and Human Services Secretary Sylvia Mathews Burwell. “I guess I’m supposed to thank you for being here, but I have to tell you I’m not in agreement with much of what you’re saying,” he announced. 
If the playground taunts achieved anything, it was to demonstrate why the stakes are so high in the looming King v. Burwell decision. If the Supreme Court does invalidate key parts of Obamacare, it seems highly unlikely that this fiercely divided Congress will have the capacity to come up with anything to replace the health-care law. The alternative to Obamacare is nothing. 

In welfare reform debate, don’t forget companies with employees on Medicaid

A long time ago I asked a mentor of mine how certain “powers that be” were getting away with some pretty questionable activities at the juncture of public and private funds. He told me it was all about what part of the story gets told, what numbers get presented. It’s all about picking what gets attention.
Our current political leadership’s idea of what constitutes welfare reform is a good example of such selective perception. And I hold both parties accountable in this regard. It is so much easier to whip people into a frenzy over “Red Bull” purchases than to undo the underpinnings of these programs and critically analyze their efficacy and their interaction with our larger economy.
Rep. Jeff McCabe, D-Skowhegan, introduced a bill that sought to do just that with the MaineCare program. LD 1324 was designed to require quarterly reports from employers with more than 50 employees regarding the number of employees and/or their family members receiving MaineCare. The report was to include data regarding levels of employment and availability of health care coverage.
This bill was presented to the Labor Committee and was killed in the Senate on June 9. It received very little press coverage and was not deemed as welfare reform, but it most certainly was the most intriguing potential piece of welfare reform legislation I heard about this session. The issue of welfare programs as employment costs subsidies for large, public for-profit corporations is a big pet peeve of mine.
The Legislature needs to get a handle on how many large companies are manipulating the system this way. If employees’ wages and hourly work limitations (i.e., employers limiting hours employees can work to deem them part time) appear designed to minimize employers’ health coverage costs, the Legislature could take action on real reform.


Our View: Maine should expedite Obamacare backup plan

If ACA subsidies are found illegal, the health of thousands of Mainers – and the fiscal stability of Maine's hospitals – will depend on our being ready to set up a state-run exchange.
BY THE EDITORIAL BOARD
If the court, in the case of King v. Burwell, rules that only people covered through state-based exchanges are eligible for insurance subsidies through the Affordable Care Act, then residents of Maine and the 33 other states that chose to use the federal exchange would lose their subsidies – and likely their health care coverage.
Lawmakers could avoid all that by passing a bill that is sensible and appropriate, yet is still being delayed.
L.D. 1344 would establish a state-run exchange in Maine if – and only if – the federal exchange subsidies are struck down by the court, which is expected to rule by the end of June.
The bill passed through committee unanimously and through the Maine House of Representatives with bipartisan support. However, the Maine Senate may delay its vote on the bill until after the Supreme Court decision.
But waiting for the high court ruling would leave Maine lawmakers in a reactive mode when the Legislature is likely to be out of session. If the court rules against the federal exchange, the state – for no real reason – will have no immediate, solid answers.
That would be bad news for the estimated 60,939 Mainers who, according to the Kaiser Family Foundation, would have their insurance put at risk. Without the subsidies, they would see their monthly premiums jump from an average of $88 to an average of $425.
That would also be bad news for Maine hospitals, which would have to deal with an upswing in emergency room visits and charity care.
These effects would be echoed in each of the roughly 34 states now using the federal exchange.

Collins Introduces Fix for Marketplace Plans Should Federal Subsidies Disappear 

By  • 16 HOURS AGO
WASHINGTON - Maine Sen. Susan Collins has introduced legislation to revamp the Affordable Care Act. The proposed "Patient Freedom Act" is designed to soften the blow of an expected Supreme Court ruling that could eliminate subsidies in the federal health law.
At stake are insurance plans purchased by 6 million Americans and 60,000 Mainers. If those subsidies disappear, Collins says the Patient Freedom Act could swoop in to the rescue. But health policy leaders in Maine say the plan would be a step backward.
In the Supreme Court case known as King vs. Burwell, plaintiffs contend that insurance subsidies offered in 37 states that use federally-run marketplaces are illegal. Maine is one of them. At issue are four critical words in the law that say subsidies are for marketplace insurance plans "established by the state."
If the Supreme Court agrees, Collins says states have two options: "They could either set up a state-run exchange to ensure that their residents have access to the Affordable Care Act's subsidies, or do nothing and allow their residents to lose these Obamacare subsidies."
The Patient Freedom Act, which Collins is sponsoring with fellow Republican Sen. Bill Cassidy, of Louisiana, offers a third option. "Participating in the Patient Freedom Act would allow states to structure their health insurance market without an individual mandate or an employer mandate, or many of the other expensive mandates under Obamacare," Collins says.
In return, Collins says, states would offer insurance through Health Savings Accounts - where consumers save money - tax free, that can only be used to pay for high-deductible insurance plans and other health expenses. Federal and state governments would chip in subsidies for lower-income individuals.
But one key component that fixes what Collins sees as a major flaw in the federal health law, is that those subsidies would gradually phase out as income increases. Under current law, Collins says, subsidies disappear off a virtual cliff once an individual earns more than 400 percent of the federal poverty level. "Taxpayers who earn just $1 more than that threshold lose their entire subsidy. That makes no sense whatsoever."
But some health policy leaders in Maine don't think Collins' proposal makes much sense. "When I read the act, it really reminds me of the movie Back to the Future," says Dr. Wendy Wolf.
Wolf is president and CEO of the Maine Health Access Foundation. She says while the Patient Freedom Act retains some of the more popular reforms under the federal health law, like protecting those with pre-existing conditions and allowing children to stay on their parents' insurance plans until age 26 - it eliminates the requirement that all health plans provide certain essential health benefits. These include things like prescription drugs, maternity care, and chronic disease management.
"If you eliminate that, it means we are then in a race to whittle benefits to eventually just have bare bones policies," Wolf says, "and we know in Maine that's what the majority of individual policy holders had prior to the Affordable Care Act, which was an average of about a $15,000 deductible plan."
Emily Brostek of Consumers for Affordable Health Care says Collins' proposal to remove the individual mandate will likely lead young, healthy people to drop out of the insurance market, which will drive up premiums for everyone else. And she's skeptical that Health Savings Accounts can be an effective replacement for marketplace insurance plans.
"There's a lot of research that shows that people in HSA's are more likely to avoid, skip or delay care compared to people with more comprehensive coverage," Brostek says. "And, you know, there's also the concern about will people even be able to afford to buy the HSA-compliant plans if the insurance rates are shooting up because we've lost the insurance mandate."


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Wednesday, June 10, 2015

Health Care Reform Articles - June 10, 2015

Obama to Supreme Court: You wouldn’t dare kill Obamacare

 Opinion writer
President Obama uttered more than 3,600 words on the stage of Washington’s Marriott Wardman Park ballroom on Tuesday, but his message could be summed up in three: You wouldn’t dare. 
He was speaking not to the hundreds of hospital administrators assembled for the Catholic Health Association’s conference but to five men not in the room: the conservative justices of the Supreme Court, who in the next 21 days will declare whether they are invalidating the most far-reaching legislation in at least a generation because of one vague clause tucked in its 2,000 pages.
Obama’s appeal to the justices, devotees of judicial modesty all: Do they really wish to cause the massive societal upheaval that would come from killing a law that is now a routine part of American life? 
“Five years in, what we are talking about is no longer just a law. It’s no longer just a theory. It isn’t even just about the Affordable Care Act or Obamacare,” he said. “This is now part of the fabric of how we care for one another. This is health care in America.”
Without mentioning the looming decision, Obama warned of its devastating potential. “Once you see millions of people having health care, once you see that all the bad things that were predicted didn’t happen, you’d think that it’d be time to move on,” he said. “It seems so cynical to want to take coverage away from millions of people, to take care away from the people who need it the most, to punish millions with higher costs of care and unravel what’s now been woven into the fabric of America.”
The appearance had been scheduled long ago, but White House officials elevated the importance of the speech to keep pressure on the Supreme Court, which Obama said at a news conference in Germany on Monday shouldn’t have even taken up the case. Obama said trashing the federal health-care exchanges, as a hostile Supreme Court ruling would do, is “not something that should be done based on a twisted interpretation of four words.” 
The conservative justices, like conservative critics of the law generally, are unlikely to be persuaded by Obama’s recitation of the merits of the law, which he repeated at length Tuesday. But they may well be reluctant to upend a law that now has broad acceptance in American society. 

Obama gives sweeping defense of healthcare law as Supreme Court ruling looms
by Noam Levey - LA Times
President Obama reentered the political battle over healthcare Tuesday, delivering an extended defense of the Affordable Care Act as the Supreme Court prepares to issue its ruling on a case that could strip away health insurance from millions of Americans.
“It seems so cynical to want to take coverage away from millions of people,” Obama said, taking a swipe at the Republicans who have backed the latest legal challenge to the law, “to take care away from people who need it the most, to punish millions with higher costs of care and unravel what’s now been woven into the fabric of America.”
Obama’s address, to a gathering of hospital leaders from the Catholic Health Assn., comes at a pivotal moment as his signature domestic achievement faces its gravest threat since being narrowly upheld by the Supreme Court three years ago.
The current legal challenge brought by conservative activists argues that a strict reading of the statute makes insurance subsidies in the law available only in states that established their own insurance marketplaces through the law.
That would strip subsidies from residents of more than 30 states that rely on the federal HealthCare.gov marketplace. More than 6 million people could lose coverage almost immediately, with millions more expected to follow as insurance markets collapse in many states.
The ruling, expected this month, is likely to reignite a fierce national political battle over healthcare that had been petering out in many places as more Americans got coverage and GOP lawmakers looked to move on to other issues.



Morning Plum: Mitch McConnell’s fiendishly clever strategy for coming Obamacare war

 

U.S. Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals

By 
WASHINGTON — Facing resistance from its Pacific trading partners, the Obama administration is no longer demanding protection for pharmaceutical prices under the 12-nation Trans-Pacific Partnership, according to a newly leaked “transparency” annex of the proposed trade accord.
But American negotiators are still pressing participating governments to open up the process that sets reimbursement rates for drugs and medical devices. Public health professionals, generic drugmakers and activists opposed to the trade deal, which is still being negotiated, contend that it will empower big pharmaceutical firms to command higher reimbursement rates in the United States and abroad, at the expense of consumers.
They also say that it could expose international markets to the direct consumer appeals that Americans have experienced.
“It was very clear to everyone except the U.S. that the initial proposal wasn’t about transparency; it was about getting market access for the pharmaceutical industry by giving them greater access to and influence over decision-making processes around pricing and reimbursement,” said Deborah Gleeson, a lecturer at the School of Psychology and Public Health at La Trobe University in Australia, who has seen the leaked document. And even though it has been toned down, she said, “I think it’s a shame that the annex is still being considered at all for the T.P.P.”
The pharmaceutical and medical device annex is the latest document obtained by The New York Times in collaboration with the watchdog group WikiLeaks, and it was released ahead of the House vote on whether to give President Obama expanded powers to complete the Trans-Pacific Partnership. The Senate has already approved legislation giving the president “trade promotion authority,” or fast-track power to complete trade deals that cannot be amended or filibustered by Congress. A House vote on final passage of the bill, which could come as early as Friday, appears extremely close.
The Pacific accord, the largest since the North American Free Trade Agreement two decades ago, would link countries stretching from Canada and Chile to Japan and Australia into a new regimen of trade rules that would cover 40 percent of the global economy.

Saving Affordable Health Insurance

By 
The Affordable Care Act, which has helped millions of people get health care, is now fully woven into the nation’s social fabric. As President Obama said Tuesday, there is something “deeply cynical about the ceaseless, endless, partisan attempts” to roll back the progress already made.
His remarks at a forum of the Catholic Health Association come only weeks before the Supreme Court is expected to issue a ruling that could, if the administration loses, eliminate federal tax subsidies in 34 states that have made it possible for millions of Americans to buy health insurance. Mr. Obama was right when he said on Monday that the court probably shouldn’t have even taken the case. Unfortunately it did, and no one can predict how the deeply divided court will rule.
The administration claims to have no contingency plan should the subsidies be invalidated. But some states, fearing the worst, are beginning to consider options, none of which look easy to carry out.
The Affordable Care Act provides subsidies in every state for low-income people who earn too much to qualify for Medicaid, the health program for the poor. Opponents of the act have seized on careless wording in the law to argue that subsidies should be available only in states that have established their own health insurance exchanges but not in states that chose to use HealthCare.gov, the federal government’s exchange. That defies common sense and the understanding of all those who passed the law in 2010. There was never any question that the A.C.A. subsidies would be available on exchanges in all the states.
There is an easy solution for the problem. Congress could pass a one-sentence law clarifying that subsidies will be available on all the exchanges. That’s what polls show Americans want. But congressional Republicans are not about to do anything realistic to help millions of people keep their health coverage, and are bent on destroying the law that made coverage possible.
As Mr. Obama noted, since he signed the law in March 2010, more than 16 million uninsured Americans have been covered, driving the uninsured rate to the lowest level ever recorded. Americans can no longer be denied coverage because of pre-existing conditions. Health care prices and employer premiums have been rising at very low rates. There are no more annual or lifetime limits on how much insurers have to pay for care. And as for the claim by Republicans that the program is a “job killer,” the nation has experienced 63 straight months of private-sector job growth, starting the month the act was passed.
It would be tragic at this point to reverse course and put millions of Americans at risk of disease and death from inadequate heath care or potential bankruptcy from inability to pay staggeringly high medical bills while disrupting insurance markets that depend on large enrollments to stabilize prices.
If the court negates the subsidies on federal exchanges, any rescue effort would have to conform with the language of the court’s ruling. The court would presumably tell the Internal Revenue Service, which interpreted the law to mean that subsidies would be available in all states, to redefine what constitutes an exchange “established by the state” and thus one that is eligible for the subsidies.
There has been some loose talk that it could be done readily — by declaring that what was previously a federally run exchange is now a state-run exchange. But experts who have looked closely at the options say converting would not be easy. While the administration would presumably try to make the transition as smooth as possible, the states that established their own exchanges in the past did so with hundreds of millions in federal grants that are no longer available and lots of technical help from the federal government. They also had time to get the job done.

A long analysis in the Yale Law Journal concluded that there are no quick, obvious remedies. To have any chance of reducing the damage, states need to start planning immediately. Among the states at risk, only Pennsylvania and Delaware have signaled intentions to do so.

Federal Panel Weighs Approving Two New Cholesterol Drugs

By 
An expert group is considering whether to recommend that the Food and Drug Administration approve two powerful new drugs to protect against heart attacks. If approved they will be the first major new class of medicines in a generation that dramatically lower levels of cholesterol, the leading cause of heart disease.
Dr. Joshua W. Knowles, a Stanford cardiologist, called the medicines “a triumph of the modern genetic revolution.”
The idea for the drugs arose from genetic studies about a decade ago and has tantalized cardiologists ever since. Early results of clinical trials have raised hopes that the drugs would be critical new additions to the arsenal of medicines for those at risk of heart disease, the biggest killer of Americans. People who have taken them have seen their LDL cholesterol, the so-called bad cholesterol, plunge to remarkably low levels. But definitive evidence of the drugs’ effectiveness in reducing heart attacks and deaths will only come after large clinical trials are completed in 2017.
Sanofi and Regeneron Pharmaceuticals’ drug, alirocumab is first on the panel’s agenda on Tuesday. Then, on Wednesday, the committee will turn to Amgen’s drug, evolocumab. The F.D.A. usually follows the recommendations of its advisory panels but not always. The agency says that if it approves the drugs based on their effects on cholesterol, the approval will not be rescinded even if the large trials fail to show the drugs reduce the risk of heart attacks and deaths.
The drugs are injected once every two weeks or once a month, depending on the formulation.
The companies and independent cardiologists say they have reason to believe the drugs will perform as expected. Lowering LDL cholesterol has generally been found to protect against heart disease. And, they say, the drugs were specifically designed to mimic mutations in a gene, PCSK9, that protects people from getting heart disease, even if they smoke or have high blood pressure.
There is a huge unmet need among patients at high risk of heart attack for whom current therapies do not work well. But the drugs have caused trepidation among insurers and others who would have to pay the bills because the drugs are certain to be expensive — perhaps ten thousand dollars a year — and millions of people are likely to qualify to take them. Sanofi estimates that 11 million Americans might qualify for the drugs. Amgen puts the number at 8 million.
So far, it looks like just about everyone who takes the new drugs responds. LDL cholesterol levels plunge by about 40 to 65 percent, even if the starting level was achieved with a statin, the mainstay drug for cholesterol lowering first introduced in the late 1980s. Companies can make levels go even lower by increasing the dose of the new drugs.
Safety studies so far have found the drugs seem to have no more side effects than a placebo. Dr. Paul Chew, Sanofi’s chief medical officer, said as many reported forgetfulness in the placebo group as in the treatment group in his company’s studies. More data should come from large clinical trials now underway that are primarily investigating whether the drugs reduce heart attacks and deaths as well as cholesterol levels. Both companies are doing multiple trials looking at effectiveness including a 27,500 patient study by Amgen and an 18,000 patient study by Sanofi.
Dr. Harlan M. Krumholz, a Yale cardiologist, cautions that until those studies are completed, it is impossible to know how they will turn out.
“We need to be careful about overreaching,” he said.
But pharmaceutical companies see the tantalizing prospect of multibillion dollar blockbuster drugs in their future, and are racing to get them to market as rapidly as possible. Sanofi paid the F.D.A. $67.5 million for an expedited review. The company says the F.D.A. agreed to decide whether to approve their drug by July 24. Amgen, which did not pay, expects an answer by Aug. 27, the company says. Pfizer also has a drug in this new class but it is further behind in development.

Federal Panel Backs Approval of New Drug to Fight Heart Attacks

By 
An expert group recommended on Tuesday that the Food and Drug Administration approve a powerful new drug to protect against heart attacks. If approved, it would be the first in a major new class of medicines in a generation that significantly lower levels of cholesterol, the leading cause of heart disease.
Dr. Joshua W. Knowles, a Stanford cardiologist, called the medicines “a triumph of the modern genetic revolution.”
The idea for such drugs arose from genetic studies about a decade ago and has tantalized cardiologists ever since. Early results of clinical trials raised hopes that the therapies would be critical new additions to the treatment arsenal for those at risk of heart disease, the biggest killer of Americans.
People who have taken them have seen their LDL cholesterol, the so-called bad cholesterol, plunge to remarkably low levels. But definitive evidence of the drugs’ effectiveness in reducing heart attacks and deaths will come only after large clinical trials are completed in 2017.
The panel, in a 13 to 3 vote, recommended the approval of Sanofi and Regeneron Pharmaceuticals’ drug, alirocumab. On Wednesday, the committee will turn to Amgen’s drug, evolocumab. The F.D.A. usually follows the recommendations of its advisory panels, but not always. The agency says that if it approves the drugs based on their effects on cholesterol, the approval will not be rescinded even if trials now underway fail to show the drugs reduce the risk of heart attacks and deaths.
Once a drug is approved doctors can prescribe it to patients other than those for whom it was intended, although insurers generally will not pay.
The drugs are injected every two weeks or once a month, depending on the formulation. The companies are asking that they be approved for use in three groups: patients with high levels of LDL cholesterol who cannot lower it enough with statins, the mainstay drug for cholesterol lowering first introduced in the late 1980s; people at very high risk because they have already had a heart attack or have diabetes and cannot get their levels low enough with statins; and people with high levels of LDL who cannot tolerate statins. Doctors often aim for LDL levels of 70 for people at high risk.
The problem for the expert group was to decide if there was enough evidence to approve the Sanofi drug without waiting for results from the large clinical trials. Those who voted no said drugs should not be approved until clinical trials established their efficacy, and voiced the worry that people participating in the trials would drop out once the drugs were approved so they could be sure to get the medicine, not a placebo.
“We need clinical outcomes,” said Dr. Peter Wilson of Emory University.
Some on the panel felt comfortable recommending approval only for a narrow group of people with a genetic condition, heterozygousfamilial hypercholesterolemia, who cannot control their cholesterol with statins alone. Others favored allowing use of the drug by the much larger group of people at high risk of heart disease for whom statins are insufficient.
The group’s chairman, Dr. Robert J. Smith of Brown University, argued for broader availability of the drugs. He said he sees patients in his own practice with out-of-control cholesterol who are at very high risk because, for example, they have already had a heart attack. Two years is a long time for them to wait for clinical trial findings. “I am unwilling to subject patients to that wait,” Dr. Smith said.
The companies and many independent cardiologists say they have reason to believe the drugs will perform as expected. Lowering LDL cholesterol has generally been found to protect against heart disease. And, they say, the drugs were designed to mimic mutations in a gene, PCSK9, that protects people from getting heart disease, even if they smoke or have high blood pressure.
But the drugs have caused trepidation among insurers and others who would have to pay the bills because the drugs are certain to be expensive — perhaps $10,000 a year — and millions of people are likely to qualify to take them if they are approved for the broader group. Sanofi estimates that 11 million Americans might qualify. Amgen puts the number at eight million.
So far, it looks as if just about everyone who takes the new drugs responds. LDL cholesterol levels plunge by 40 to 65 percent, even if the starting level was achieved with a statin.


The Lobbying Bonanza

by Thomas Edsall - NYT
A once-decrepit section of downtown Washington has become a luxury marketplace, feeding off the lavishly paid men and women successfully representing the political agenda of the corporate sector.
In 1993, when Tony Podesta, a top Washington lobbyist, moved his firm to G Street Northwest, the neighborhood was a skanky collection of warehouses, liquor stores and the remains of a red light district.
Traditionally, K Street has been synonymous with the lobbying industry, but maybe now we should be talking about Podesta’s section of downtown, 10 blocks closer to the Capitol and home to a growing share of the special-interest community.
The money is flowing. Podesta’s own company made $25.1 million in lobbying fees last year, plus another $10 million for its public relations work. From Podesta’s office, it’s just a two-minute walk to the new City Center development and its deluxe retail offerings. Paul Stuart on I street sells a navy chalk stripe Italian suit for $4,984. Around the corner is Louis Vuitton, where the Président Classeur briefcase sells for $9,700. A half-block away is Hermès, manufacturer of the Birkin bag, one of which sold recently at auction in Hong Kong for $221,846.
Most lobbying compensation packages are closed to public view, but some – especially of top officials working for tax-exempt trade associations – are not. In 2012, National Journal identified 12 trade association executives making over $2 million a year.
Among the top earners in that select group were Jack Gerard of the American Petroleum Institute, $6,428,872; Thomas J. Donohue, United States Chamber of Commerce, $4,761,900; and Thomas R. Kuhn, Edison Electric Institute, $4,006,893.
Lobbyists are not required to disclose their income, but they do have to report their fees to the Clerk of the Houseand to the Senate Office of Public Disclosure.
In 2014, Lee Drutman, a senior fellow at New America, conducted a study for the Sunlight Foundation that revealed that there were 799 registered Washington lobbyists whose fees for at least one year between 1998 and 2012 exceeded $1 million.
At the same time that the business of influencing government has grown more lucrative, the city’s college-educated, affluent, largely but not exclusively white work force has grown by leaps and bounds.
White median household income grew by 71 percent in the District of Columbia from 2000 to 2013, nearly three times faster than the growth of black household income, at 25.1 percent. Median income for white families in the District was $170,364, 292 percent higher than the nationwide figure, $58,270.
Washington is among the most rapidly gentrifying cities in the nation. From 2000 to 2014, the population of the District of Columbia grew by 15.2 percent, to 658,893, from 572,059. The number of African-American residents fell to 326,152, or 49.5 percent, from 343,312, or 60 percent, while the number of white residents grew to 235,884, or 35.8 percent, from 159,178 or 27.8 percent.
A former member of Congress entering the influence business can easily double or triple his or her government salary, one of Washington’s more successful lobbyists (who insisted on anonymity), told me. A hardworking and enterprising former member “can go as high as $2 million a year” if he or she is “willing to hustle.” To get above $2 million, he said, “you have to have people working for you. You can’t have all 15s; you have to have 50s and above.”
Lobbying has its own shorthand. Fifteens are clients who pay $15,000 a quarter; in Washington, they are a dime a dozen. Fifties and above are those paying $50,000 or more a quarter.
To what extent does the increasing affluence of Washington – together with politicians’ growing dependence on the rich for campaign contributions and the fact that the median net worth of members of Congress is now $1.03 million– have an impact on public policy?


Assembly panel supports California vaccination mandate
By 
proposal to require many more children to be vaccinated in California was approved Tuesday by a state Assembly committee despite opposition from hundreds of parents, many of whom argued they should be able to choose what medical treatment to seek for their children.
The 12-6 party line vote by the Assembly Health Committee sends to the full Assembly a bill that would eliminate the ability of parents to exempt their children from being vaccinated based on personal beliefs.
It would leave only medical issues, such as a compromised immune  system, as a reason a child would not be immunized before entering kindergarten. The Senate previously approved the measure.
“This is fundamentally a bill about public health. Every child deserves the right to go to school in a safe and healthy environment,” said Assemblyman Rob Bonta (D-Alameda), the chairman of the panel at the end of the five-hour public hearing.






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