New England Journal of Medicine Prints Report Critical of GlaxoSmithKline Drug (Updated)

The Boston Globe reported today that a new study released early by the New England Journal of Medicine on its website questions the safety of one of the largest-selling diabetes medications in the country, Avandia.

Avandia, the world’s top-selling oral diabetes drug, significantly increases the risk of heart attacks, a prominent cardiologist said in an article that the New England Journal of Medicine deemed important enough to post on its website yesterday, weeks before the scheduled print publication date.

Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic and the article’s lead author, pored through summaries of dozens of studies and found a 43 percent higher risk of diabetics suffering a heart attack if they took Avandia compared with other drugs or sugar pills. Nissen was unable to determine whether the risk is affected by how long Avandia is used or how much is taken.

***

“The leading cause of death in diabetes is heart disease. It causes between 65 to 80 percent of all diabetes mortality,” Nissen said in an interview. “When a diabetes drug, which is intended to reduce the risk of diabetes complications, actually increases it, it has profound public health consequences.”

In an accompanying editorial published by the New England Journal of Medicine, Bruce Psaty and Curt Furberg, doctors who are critics of the FDA’s drug-approval process, said there is little reason for doctors to prescribe Avandia….

(emphasis added)

The drug is produced by GlaxoSmithKline, a major player in Big Pharma, and is worth over $$$3BIL$$$/year in sales worldwide. GSK immediately attacked the report, claiming it’s “flawed”.

That’s not particularly surprising, nor is it surprising that after the Vioxx debacle, the release of the report triggered a nosedive of GSK’s stock.

Since the Food and Drug Administration approved Avandia in 1999 doctors have written tens of millions of prescriptions for the drug. The Journal released the paper in advance of its June 14 print publication date partly because of its public health impact, according to executive editor Dr. Gregory Curfman.

Investors and others, including members of Congress, yesterday reacted strongly to the article.

GlaxoSmithKline shares closed at $53.18, down 7.85 percent, in heavy trading.

(emphasis added)

The big question here is, “Where was the FDA?”

Medicare Drug Benefit Turns Into Bonanza for Big Pharma

It didn’t take a genius to figure out that Bush’s prescription drug plan – you know, the one that expressly forbids Medicare from bargaining over prices – was going to turn fairly quickly into a bonanza for Big Pharma, so I don’t imagine it will be much of a surprise to learn that that’s exactly what’s happening.

After some initial success containing drug prices, private insurers in the new Medicare prescription drug program may be losing their leverage over drug manufacturers as they try to hold down medicine costs for seniors and the federal government, House investigators have found.

Prices for 10 of the most prescribed brand-name medications have shot up an average of 6.8 percent since December under Medicare private insurance plans, while wholesale prices for the same drugs have risen just 3 percent, House Oversight and Government Reform investigators say. The cost of a month’s supply of cholesterol-controlling Lipitor had climbed 9.6 percent, to $84.27 in mid-April, from $76.91 in mid-December. Over the same time, list prices climbed 5 percent.

Premiums for Medicare drug plans have jumped 13 percent over the past year, when the drug plans went into effect, the investigators say.

And the rebates that insurance companies are wringing out of drug manufacturers are expected to total 4.6 percent of total drug costs, down from 5.2 percent last year. A year ago, Medicare actuaries had expected insurers in 2007 to secure manufacturers’ rebates of 6 percent, then pass those savings on to seniors and the government.

“Essentially as an economist this is just what I would have predicted,” said Marilyn Moon, director of the health program at the American Institutes for Research and a former trustee for Medicare and Social Security. “When you introduce a new program, with all of the fanfare, everyone is anxious to get the best prices, the best look and demonstrate the private sector can handle it. But over time, when you’ve gotten your customers lined up, prices tend to slip upward.”

“Slip upward”? Slip?! They didn’t slip. They were pushed.

Economists and accountants always like to talk as if the market is a force of nature with its own rules that’s beyond any human’s control, but that’s bullshit. Actually Moon explains the problem quite competently if you put aside the force majeure thang: once a corporation’s got you hooked, it can abandon loss-leader pricing and return to its comfort zone – unrestricted greed.

Prescription Drugs in America: A Daughter Turns Smuggler

This is a personal anecdote, it’s true, but it’s a story that is being replicated by the millions every day. The Bush Administration’s fawning over the heavily-contributing pharmaceutical industry has made America into a Third World country where everyone except the very rich may have to break the ‘laws’ that govern drug sales in the US if they want to keep sick relatives from dying. The FDA, originally intended to protect us from dangerous or poorly manufactured drugs, has become under Bush the profits-protector and dogsbody of the pharmaceutical industry, cracking down on Americans trying to find alternate foreign sources for drugs they can’t afford to buy legally here.

The new drug my father’s oncologist was prescribing for him was well known to me (for legal reasons, I will omit its name and the manufacturer’s name), for it had a fearsome reputation from decades earlier. How expensive could this drug be, I wondered, when all the research and development had been done 40 years ago, at a fraction of the modern costs? A hell of a lot, was the answer. I still don’t know why. But in my father’s case, it was about $47,000 a year, with the potential to triple, based on his clinical response, to $141,000 a year. At this rate, in seven years, he could conceivably have spent a million dollars. Although he had profited from decades of employment in North America, he had not profited well enough to pay for that, and he was realistic enough about his medical future to resist becoming “spent out”—the current jargon for those who have anted up all in pursuit of staying alive—leaving him and my mother financially ruined (at which point, ironically, they would have been eligible for free drugs).

Like millions of frustrated others, I turned to the Internet, hoping to find some way of acquiring what my father needed. There was a whole cadre of us out there, I learned, seeking drugs for ill parents, or spouses, or children. There were those looking, and those giving—including the survivors of the deceased, who were willing to pass along the remnants of no-longer-needed prescriptions.

This was new to me, this drug-recycling, and sadder perhaps than the need to go outside the US to find affordable medications. The idea that in the United State of America, the richest and most powerful country on earth, its citizens–and not just the poor–are being reduced to stockpiling old, left-over prescriptions in order to pass them on to others who cannot afford to pay the outrageous prices drug companies charge for them, almost made me cry–and scream in rage at the same time.

I know what this means. It means going through the drawers and the medicine chest and the bedside table of a deceased relative after the funeral, and then checking the wastebaskets for what might have been thrown away and the closets and pockets and nooks-and-crannies where medicine may have been left and forgotten in the last days. It means knowing that someone’s life may be saved by your doing this, yes, but it also means understanding that someone else may die who doesn’t have to if you don’t.

Think about that: people are conceivably dying in America because bereaved survivors either don’t know of the need or can’t bring themselves in their grief to separate a loved one’s drugs into what is useful and needed and what is not. In other words, someone is dying because someone else isn’t picking through the trash of one who has passed. Like vultures, we have been reduced to feeding off the leavings of the dead. I’m having a hard time getting my head around that.

Upon my father’s retirement in 1991, he automatically became covered by Medicare and chose to purchase supplemental AARP hospitalization insurance. He decided against the supplemental prescription-drug insurance because, as he later told me, he could not conceive of any drug costing enough to justify paying $2,400 a year for it. For me, one of the more painful aspects of our predicament was the fact that my father, a son of the Depression and of World War II, prided himself on always being prepared for the bleakest prospects the future might deliver. But not even his darkest imaginings could prepare him for the breathtaking ascent in the price of drugs—costing Americans $213.4 billion in 2003—which he regarded as a personal failure of his preparedness skills.

Because more than a third of Medicare patients have no prescription-drug benefits, Congress enacted the Medicare drug bill last December, at an estimated cost of $400 billion over the next decade. In the weeks following its passage, it became a matter of morbid curiosity to me to assess whether or not the new law would have solved my father’s problems. If he had survived, here is what he might have looked forward to: After paying a $420 annual premium, plus a $250 annual deductible, the government would have covered 75 percent of his prescription costs up to $2,250; he would then have been responsible for all payments up to $5,100, at which time the government’s catastrophic aid would have kicked in, paying 95 percent of his drug expenses. So I estimate that he would have been responsible for $6,115 of his $47,000 cancer drug. Would he have paid that much? I can’t say for sure. Locked into a fixed income that was in decline along with the stock market, he might have decided against it. (emphasis added by me)

She’s probably talking about a pension plan, but that is what the next generation can look forward to if the Pubs go through with their plans to privatize Social Security–people will live or die, literally, based on how well their retirement stock portfolio is doing–if they have one.

If he had been a middle-income senior with modest drug costs, he would probably have fared no better and might have ended up paying more in annual premiums than his drugs cost. If his expenditures had fallen into the “doughnut hole,” between $2,250 and $5,100, he would have found little relief. Ironically, his worst-case scenario under the new plan would have been a complete reversal of what had been the best-case scenario, i.e., a retiree who still enjoys employer-paid health coverage. Such people were once the lucky few; but under the new legislation, all 3.8 million of them stand to lose that coverage entirely. And those whose new Medicare drug bene-fits will be provided via privately run programs could find themselves denied expen- sive drugs, say, ones that cost $47,000.

So who will fare well? Doctors and hospitals will get a boost, because a scheduled cut in their Medicare payments has been eliminated. The insurance companies will receive new subsidies designed to encourage them to cover seniors and the disabled. But the really big winners will be the drug companies, who are estimated to see a 9 percent increase in sales, or $13 billion in additional profits per year.

Hard as it may be to believe, that estimate is low–I’ve seen some reasonably reliable reports that project as much as twice that. The final numbers, according to one study, may depend on how many families choose bankruptcy over death–and how many of the dying choose ‘death with dignity’ over turning their loved ones into paupers in order to enlarge the already obscene profits of drug corporations.

It’s a long article I can only excerpt, but I urge you to read the rest of the story of what this woman went through trying to find the drug that would keep her father alive. It’s a sobering account of the fight we will all one day face if the drug corporations aren’t brought to heel. Along the way, she debunks the ‘R&D’ argument drug corporations use to justify their prices (predictably, they spend more than twice as much on marketing as they do on research–$45Billion to less than $20Billion for R&D) and describes the hoops the FDA made her jump through in order to satisfy the Corporations that her ‘need’ was genuine. It’s a terrifying picture of what happens when govt is ‘friendly’ with Big Business–they work together to give the rest of us the shaft.

I will leave you with this:

We had already tried this—back in the beginning—following the advice of one of my father’s doctors, who suggested that we need not be “entirely truthful” as to his financial situation on the application. So we lied, but only a little, and were rejected. Now, a year later, we would try again, and I was prepared to be utterly ruthless this time. It did not feel like stealing because, in all honesty, I didn’t feel bad about milking a company so willing to do the same to us.

---

In response to the high prices, a few states and municipalities are beginning to flex their bargain-hunting muscles too. Springfield, Massachusetts, is reimporting drugs from Canada for its city employees. Burlington, Vermont, plans to follow. Boston announced it will do so for 7,000 employees and retirees, saving an estimated $1 million a year. New Hampshire plans to reimport for its prison population and Medicaid patients. Initially, the U.S. government seemed to take this trend in stride. But last December, when Illinois announced its plan to save $91 million by reimportation, Governor Blagojevich was warned by the feds that such a move would be illegal. “Our law is very specific,” said a government spokesperson. “It’s not ‘will not.’ It’s ‘cannot.'” And drug companies are also being aggressive: GlaxoSmithKline warned Canadian pharmacies to stop selling to Americans or their supplies would be shut down.In the wake of this anarchy, a few in Congress are re-examining a bill sponsored by Rep. Gil Gutknecht of Minnesota that would allow reimportation from FDA-approved facilities in 25 industrialized countries and employ technology to prevent counterfeiting. But if the pharmaceutical industry gets its way, such legislation will die—turning an increasing number of sick and desperate Americans into outlaws, or forcing them into early graves.

Meanwhile, my contact information floats in cyberspace, and I continue to get requests from the others out there with first names only who are looking for the same drug my father once used. I am more than happy to tell them what I know, how to work the system, how to break the law. “Thanks so much!” one contact responded. “(And thank goodness for email and the wonderful network of caring people such as you.) This is terrific information! Until the FDA comes to its senses, it seems that those overseas are truly our friends.”

One for Our Side

U.S. to Drop Benefit Cuts Linked to Drug Discounts
By ROBERT PEAR

Published: NY Times, June 13, 2004

WASHINGTON, June 12 – The Bush administration said Saturday that it would rescind a federal policy that threatened to cut food stamp benefits for several million low-income elderly and disabled people who save money on their medicines by using the new Medicare drug discount cards.

The administration’s reversal came two days before President Bush was scheduled to visit Missouri to promote use of the cards, which have received a tepid reaction from many Medicare beneficiaries.

In interviews this week, state officials across the country said low-income people who used the cards could find their food stamp benefits reduced as a result. The cuts, they said, were a direct result of federal regulations and a policy statement issued by the Agriculture Department on March 10.

The purpose of the discount cards is to reduce out-of-pocket drug costs. But when a person’s drug expenses go down, state officials said, the food stamp program assumes that the person has more money available to spend on other needs, including food. So the person may receive a smaller food stamp allotment, they said.

Judy K. Toelle, the food stamp director in South Dakota, confirmed that such cuts would occur under the federal rules. For example, she said, a woman with monthly income of $1,060, shelter expenses of $555 and drug costs of $325 now receives $51 a month in food stamps. But, she said, if the card reduced her out-of-pocket drug costs by $100, the woman would get $41 less in food stamps, so the net saving would be $59.

Food stamp officials in California, Colorado, Missouri , New Mexico and Washington State said they were simply following federal rules in reducing food stamp benefits to take account of the fact that people with discount cards spent less on prescription drugs. Those regulations have not been changed.

But after inquiries from The New York Times, Eric M. Bost, an under secretary of agriculture, said, “We will immediately be clarifying policy guidance to ensure that food stamp applicants or recipients who use the new Medicare discount card will experience no impact on their eligibility or benefits.”

The abrupt shift highlights the confusion between federal and state officials, and between the two federal agencies that administer Medicare and food stamps.

‘Confusion’? The only confusion is that Bost, the guy who thinks hunger shelters are shopping centers for suburban Moms, forgot that Bush was trying to get re-elected on the old ‘compassionate conservative’ ploy. So somebody reminded him.

Elections are good for stuff like this.

How do you hold down the cost of a govt program aimed at the poor? Don’t tell ’em about it

You may remember that the Bush Administration was forced into proposing a drug benefit to help seniors offset the ridiculously high prices for drugs which the pharmaceutical companies claim helps them reclaim their ‘development costs’ even though they usually develop those drugs on the US govt dime, making those ‘costs’ minimal. Junior got elected at least in part (the election wouldn’t have been close enough to steal, otherwise) by appropriating this Democratic initiative.

But with the BA, as we’ve come to know, there’s a big difference between passing a social program and paying for it. With the No Child Left Behind Act, for example, they passed the law without appropriating the money for it, effectively forcing the costs onto the local tax structure. With the drug benefit, we’re seeing a different tactic: don’t tell ’em about it.

Bush administration officials say the drug discount card would save Medicare-eligible residents from 10% to 18% on brand-name drugs and from 30% to 60% on generics until 2006, when the government’s Medicare prescription drug subsidy kicks in. Many low-income seniors at the complex qualify for an even better deal: a $600 annual subsidy plus substantial savings from some drug manufacturers for individuals who earn less than $12,569 a year and couples who make less than $16,862.But days before the discount card was set to take effect, no one among 10 Lakeview seniors gathered in the lobby of the complex had enrolled in the program.

None of seniors had received materials from the government or promotional mailings from private card sponsors explaining the program. They were eager to learn more about the card but said they didn’t know the government’s toll-free information number and didn’t have access to the Medicare website. No one had come to the complex to tell residents about the discount card, they said.

“I wish they would,” said Rhonda Van Dyke, Lakeview’s manager. “For most of our residents, this would really help.”

That’s why they’re not telling them, dear. They have a couple of other little tricks up their sleeves, too.

1) Make the system too confusing to understand.

Democrats and some consumer groups have produced studies showing that seniors could save more money by shopping around on the Internet or buying their prescription drugs from Canada.Even many Republicans, seniors’ groups and private card sponsors acknowledge that the enrollment process, which requires seniors to choose from among 40 national cards and some of the 33 regional ones, is cumbersome and confusing.

Yet nearly everyone, including the harshest critics of the new Medicare law, agrees that the $1,200 low-income subsidy — $600 this year and another $600 in 2005 — would make the discount card a sure-fire winner for most of the 7.2 million poor seniors believed to be eligible.

2) Put the enrollment program on the internet for a target population that has the lowest percentage of computer ownership and internet access.

Earlene Smooth, 76, takes six prescription drugs for hypertension and diabetes. “If it wasn’t for my children helping me sometimes, I wouldn’t get my medicine,” she said.But the bespectacled widow, sharply dressed in a lime green sweater, floral-print skirt and white moccasins, said she did not plan to sign up for the discount card.

“I read about it but I don’t understand it,” she said. “They tell you to go on the computer, but everybody doesn’t have the computer. There’s no way to really find out what’s better for me. The government should really have a plan you can understand.”

They would if they wanted you to participate, Earlene. They don’t, that’s the whole point of this exercise. The fewer people sign up, the fewer expensive prescriptions they have to pay for. And these tactics are working.

James P. Firman, chairman of the Access to Benefits Coalition, a network of 68 nonprofit groups working to tell low-income seniors about the discount card, welcomed the federal funds but said new strategies, corporate partnerships and still more money would be needed to achieve the coalition’s goal of enrolling 5.5 million poor beneficiaries by the end of next year.”Most public benefits outreach efforts until now have been to find needles in a haystack,” said Firman, who also is head of the National Council on Aging. “We believe the challenge is to find the stacks of needles.”

But what about the tv ads the BA paid for? Those are informational, aren’t they? Didn’t those tell everybody where to go and what to do?

Well, um, not exactly. From an NYT report:

The videos–produced by the Department of Health and Human Services…praising the benefits of the new Medicare law, which would be offered to help elderly Americans with the costs of their prescription medicines–are intended for use in local television news programs. Several include pictures of President Bush receiving a standing ovation from a crowd cheering as he signed the Medicare law on Dec. 8.

The BA used the money that was supposed to be used for informational videos to produce thinly-veiled campaign ads taking credit for the program they don’t explain. Result?

John H. Robinson, 71, fished his worn Medicare card out of his pocket and said he got no help in paying for his prescriptions. “I pay across the board, $287 a month,” he said, for three prescriptions for his heart, blood pressure and kidneys.Robinson, who lives on Social Security, probably would qualify for the Medicare card’s low-income subsidy but doesn’t know how to get it. “I heard something on the TV,” he said, “but no one’s told me about it.”

They don’t miss a trick, those Bushies.