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“From The Roberts Fab Five”: With No Accountability Or Liability, Generic Drug Companies Get Even More Immunity

Monday’s U.S. Supreme Court ruling immunizing drug companies from lawsuit for egregious injuries wasn’t terribly surprising for those who have been following along. Two years ago, in a case called PLIVA v. Mensing, the U.S. Supreme Court held that generic drug companies were largely immune from lawsuits alleging their failure to warn of harmful consequences. On Monday, in a 5-4 ruling along ideological lines, the court extended this holding to apply to other types of claims against generic drug manufacturers, and held that a federal statute precluded suit by a woman who incurred burns on 60 percent of her body and was rendered legally blind by an alleged drug defect.

This ruling was a predictable addition to the line of cases immunizing big business from liability, but it was not an inevitable follow-up to PLIVA. In conjunction with two other rulings Monday that stomped on workplace protections for minorities and women, this decision brings the top corporate lobby’s win rate before the U.S. Supreme Court term to 13-3. With one case remaining in which the Chamber of Commerce weighed in, it is clear that however that final case is decided, big business won very big at the expense of the little guy.

As has been a frequent practice by the Roberts Court, the five-justice majority found that federal law trumped state law protecting patients, over protestations from the four dissenting justices that both federal and state law could co-exist. Interpreting a federal law requirement that generic drug companies simply follow the warnings and design of the brand name drug, the court held that generic companies cannot be held liable for its flaws. This means that a generic company that distributes a dangerous product has no obligation to simply stop selling that drug, and can go on dispensing the potentially dangerous substance with immunity. As Justice Sonia Sotomayor wrote in dissent, the court justified its holding through “an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability.”

The majority holding in this case overturned a $21 million verdict — upheld by the appeals court — for the plaintiff’s alleged injuries. Now, the company owes nothing. With 80 percent of U.S. prescriptions filled by generics, this ruling not only wipes away generic manufacturers’ responsibility to halt the sale of dangerous products; it also impacts safety for the great majority of consumers.

According to a Public Citizen report released Monday, much of the safety information about a drug emerges after FDA approval, once the drug enters the market. And it is often not the case that the FDA revisits approval. As Justice Stephen Breyer explains in his dissent, it is “far more common for a manufacturer to stop selling its product voluntarily after the FDA advises the manufacturer that the drug is unsafe and that its risk-benefit profile cannot be adequately addressed through labeling changes or other measures” than for the FDA to formally withdraw approval based on new information.

In the wake of the PLIVA decision, members of Congress had asked FDA to revise its regulations in ways that will now be doubly essential to consumer safety. In the absence of clarity from Congress or the FDA, today’s decision paves the way for a whole lot of malfeasance.

 

By: Nicole Flatow, Think Progress, June 24, 2013

June 26, 2013 Posted by | Big Pharma, SCOTUS | , , , , , , , | 1 Comment

“Profits Before Patients”: National Drug Shortages Are Threatening Cancer Patients’ Lives

Millions of Americans battling cancer are facing obstacles to recovery that have nothing to do with the disease’s toll on their bodies. According to a new study, national shortages of cancer drugs are threatening the health of the people who rely on them to stay alive.

According to the survey, presented at an oncology conference in Chicago on Monday, about 83 percent of cancer specialists have experienced a drug shortage at their clinics in the past six months. Of those doctors, 92 percent said the shortage had some effect on their patients’ care.

A little over a third of the doctors facing a shortage ended up switching their patients from a cheaper, generic version of that drug to a more expensive brand-name version. Considering the fact that cancer care is already exorbitantly expensive — Americans battling cancer are twice as likely to wind up bankrupt compared to those who don’t have the disease — that could represent a serious strain on those patients.

But cancer patients are facing much more than potential financial hardship. Thanks to the shortages, some cancer specialists can’t find the drugs their patients need at any price. When that happens, doctors are forced to make some painful choices. Nearly 80 percent reported that they switched patients to a different, and potentially less effective, chemotherapy regimen. Some have been forced to give cancers more time to spread further by delaying patients’ treatment or reducing their doses. And 37 percent of the study’s participants even had to choose between their patients, deciding which ones could receive life-saving medication and which ones would have to go without.

William Li, the executive director of a foundation that sponsors research into blood vessel growth, told USA Today that some hospitals are forced to hold lotteries to decide which patients will be able to receive the cancer drugs that are in short supply. “It baffles the mind that this is happening in a modern society,” Li said, pointing out that the FDA should do more to avert drug shortages.

Currently, drug manufacturers can alert the FDA when they suspect an impending shortage, and the federal agency can take steps to try to mitigate the effect on the market, like approving the same kind of drug from a different manufacturer. But so far, that hasn’t been enough to avert the situation. Largely due to manufacturing errors in drug-production facilities across the country, the U.S. faces limited supplies of everything from ADHD medications to painkillers — and cancer patients end up being hit the hardest.

Much of the blame may lie with powerful pharmaceutical companies. One of the co-authors of the new study, Keerthi Gogineni, noted that cancer doctors are concerned drug manufacturers may be prioritizing the most profitable medications over the most life-saving ones. “Some manufacturers have diverted existing production capacity from less profitable agents to more expensive agents,” Gogineni explained. Similarly, a group of over 100 doctors recently criticized Big Pharma for “causing harm to patients” by continuing to sell cancer drugs at unsustainably high prices.

 

By: Tara Culp-Ressler, Think Progress, June 3, 2013

June 4, 2013 Posted by | Big Pharma, Health Care | , , , , , , | Leave a comment

When Food Kills: A Threat To Public Health

The deaths of 31 peoplein Europe from a little-known strain of E. coli have raised alarms worldwide, but we shouldn’t be surprised. Our food often betrays us.

Just a few days ago, a 2-year-old girl in Dryden, Va., died in a hospital after suffering bloody diarrhea linked to another strain of E. coli. Her brother was also hospitalized but survived.

Every year in the United States, 325,000 people are hospitalized because of food-borne illnesses and 5,000 die, according to the Centers for Disease Control and Prevention. That’s right: food kills one person every two hours.

Yet while the terrorist attacks of 2001 led us to transform the way we approach national security, the deaths of almost twice as many people annually have still not generated basic food-safety initiatives. We have an industrial farming system that is a marvel for producing cheap food, but its lobbyists block initiatives to make food safer.

Perhaps the most disgraceful aspect of our agricultural system — I say this as an Oregon farmboy who once raised sheep, cattle and hogs — is the way antibiotics are recklessly stuffed into healthy animals to make them grow faster.

The Food and Drug Administration reported recently that 80 percent of antibiotics in the United States go to livestock, not humans. And 90 percent of the livestock antibiotics are administered in their food or water, typically to healthy animals to keep them from getting sick when they are confined in squalid and crowded conditions.

The single state of North Carolina uses more antibiotics for livestock than the entire United States uses for humans.

This cavalier use of low-level antibiotics creates a perfect breeding ground for antibiotic-resistant pathogens. The upshot is that ailments can become pretty much untreatable.

The Infectious Diseases Society of America, a professional organization of doctors, cites the case of Josh Nahum, a 27-year-old skydiving instructor in Colorado. He developed a fever from bacteria that would not respond to medication. The infection spread and caused tremendous pressure in his skull.

Some of his brain was pushed into his spinal column, paralyzing him. He became a quadriplegic depending on a ventilator to breathe. Then, a couple of weeks later, he died.

There’s no reason to link Nahum’s case specifically to agricultural overuse, for antibiotic resistance has multiple causes that are difficult to unravel. Doctors overprescribe them. Patients misuse them. But looking at numbers, by far the biggest element of overuse is agriculture.

We would never think of trying to keep our children healthy by adding antibiotics to school water fountains, because we know this would breed antibiotic-resistant bacteria. It’s unconscionable that Big Ag does something similar for livestock.

Louise Slaughter, the only microbiologist in the United States House of Representatives, has been fighting a lonely battle to curb this practice — but industrial agricultural interests have always blocked her legislation.

“These statistics tell the tale of an industry that is rampantly misusing antibiotics in an attempt to cover up filthy, unsanitary living conditions among animals,” Slaughter said. “As they feed antibiotics to animals to keep them healthy, they are making our families sicker by spreading these deadly strains of bacteria.”

Vegetarians may think that they’re immune, but they’re not. E. coli originates in animals but can spill into water used to irrigate vegetables, contaminating them. The European E. coli outbreak apparently arose from bean sprouts grown on an organic farm in Germany.

One of the most common antibiotic-resistant pathogens is MRSA, which now kills more Americans annually than AIDS and adds hugely to America’s medical costs. MRSA has many variants, and one of the more benign forms now is widespread in hog barns and among people who deal with hogs. An article this year in a journal called Applied and Environmental Microbiology reported that MRSA was found in 70 percent of hogs on one farm.

Another scholarly journal reported that MRSA was found in 45 percent of employees working at hog farms. And the Centers for Disease Control reported this April that this strain of bacteria has now been found in a worker at a day care center in Iowa.

Other countries are moving to ban the feeding of antibiotics to livestock. But in the United States, the agribusiness lobby still has a hold on Congress.

The European outbreak should shake people up. “It points to the whole broken system,” notes Robert Martin of the Pew Environment Group.

We need more comprehensive inspections in the food system, more testing for additional strains of E. coli, and more public education (always wash your hands after touching raw meat, and don’t use the same cutting board for meat and vegetables). A great place to start reforms would be by banning the feeding of antibiotics to healthy livestock.

By: Nicholas D. Kristof, Op-Ed Columnist, The New York Times, June 11, 2011

June 13, 2011 Posted by | Congress, Consumers, Corporations, Environment, Government, Homeland Security, Lobbyists, Politics, Public Health | , , , , , , , , , , , , | Leave a comment

Bad News For Americans Who Eat Food

In December, Americans who eat food received some very good news. A sweeping overhaul of the nation’s food-safety system, approved by both chambers with large, bipartisan majorities, cleared Congress, and was quickly signed into law by President Obama.

The long-overdue law expands the FDA’s ability to recall tainted foods, increases inspections, demands accountability from food companies, and oversees farming — all in the hopes of cracking down on unsafe food before consumers get sick. This was the first time Congress has approved an overhaul of food-safety laws in more than 70 years.

That’s the good news. The bad news is, the Republican-led House is fighting to gut the law.

Budget cuts proposed by House Republicans to the Food and Drug Administration would undermine the agency’s ability to carry out a historic food-safety law passed by Congress just five months ago, food safety advocates say. […]

To carry out the new law, President Obama is seeking $955 million for food safety at the FDA in the fiscal year that starts Oct. 1.

Last week, the House Appropriations subcommittee that oversees the FDA pared back that amount to $750 million, which is $87 million less than the figure the agency is currently receiving for food safety.

“This subcommittee has begun making some of the tough choices necessary to right the ship,” said Chairman Jack Kingston, (R-Ga.).The full committee was scheduled to vote on the proposed cuts Tuesday, and the budget proposal was expected to pass.

Republicans on the House Appropriations Committee approved the cuts yesterday, which are severe enough to prevent the FDA from implementing the new law. Erik Olson, director of food and consumer product safety programs at the Pew Health Group, part of a coalition of public health advocates and food makers, said this week, “These cuts could seriously harm our ability to protect the food supply.”

Boy, those midterm elections really set the country on the right path, didn’t they?

It’s also worth appreciating the fact that these cuts to food safety were made in the name of fiscal responsibility, but it’s a classic example of being penny wise and pound foolish. Indeed, cutting funding on food safety is likely to cost us more money, not less.

I realize this may seem counter-intuitive. I can even imagine some Fox News personality telling viewers, “Those wacky liberals think it costs money to cut spending! What fools!”

But this just requires a little bit of thought. When we cut spending on food safety, we save a little money on inspection, but end up paying a lot of money on health care costs when consumers get sick.

The GOP approach is misguided as a matter of public health, public safety, and budgeting.

 

By: Steve Benen, Contributing Writer, Washington Monthly, June 1, 2011

June 2, 2011 Posted by | Congress, Conservatives, Consumers, GOP, Government, Health Care, Ideology, Lawmakers, Politics, President Obama, Public, Public Health, Regulations, Republicans | , , , , , , , , , , , , , | Leave a comment

Drugs and Profits: Pharmaceutical Companies Should First Do No Harm

Last year the Food and Drug Administration rescinded approval of the drug Avastin for treating breast cancer patients, prompting a firestorm of criticism. The decision was denounced by some politicians as health care rationing, and by breast cancer patients who feared that they would be deprived of a drug that they felt had helped them immensely.

But these criticisms ignore the facts: Avastin was rejected simply because it didn’t work as it was supposed to, and the F.D.A. should resist the aggressive campaign by Genentech, the drug’s maker, to get that ruling reconsidered at a hearing in late June.

Avastin has been on the market for seven years, and combined with other drugs it is effective in treating, but not curing, some colon, lung, kidney and brain cancers. It inhibits the development of new blood vessels and in so doing can starve a growing tumor.

Treating a breast cancer patient with Avastin costs about $90,000 a year, and Genentech could lose $500 million to $1 billion a year in revenue if the F.D.A. upholds the ban.

A clinical trial published in 2007 demonstrated that Avastin, when paired with the chemotherapy drug Taxol, halts the growth of metastatic breast cancer for about six months longer than chemotherapy alone. Genentech then asked the F.D.A. for approval of Avastin, combined with Taxol, for use against metastatic breast cancer.

This halt in tumor growth is known as progression-free survival. But delaying the worsening of cancer does not necessarily prolong life, and Avastin was not shown to lengthen patients’ overall survival time. So Genentech argued that the drug led not to longer life, but to improved quality of life.

In 2007, an F.D.A. advisory committee rejected the application, deciding that the toxic side effects of Avastin outweighed its ability to slow tumor growth. The F.D.A., however, overrode the committee and granted what is called accelerated approval, allowing Avastin to be used pending further study. The criteria for full approval was that Avastin not worsen overall survival and that the drug provide clinically meaningful progression-free survival.

To support its case Genentech submitted data from two additional clinical trials in which Avastin was paired with chemotherapy drugs other than Taxol. Like the first trial, neither showed a survival benefit. Both showed an improvement in progression-free survival, though this outcome was much less impressive than in the original study. In addition to seeking full approval for the Avastin-Taxol combination, Genentech also asked the F.D.A. to approve the use of Avastin with the drugs used in these follow-up studies.

Genentech presented progression-free survival as a surrogate for better quality of life, but the quality-of-life data were incomplete, sketchy and, in some cases, non-existent. The best that one Genentech spokesman could say was that “health-related quality of life was not worsened when Avastin was added.” Patients didn’t live longer, and they didn’t live better.

It was this lack of demonstrated clinical benefit, combined with the potentially severe side effects of the drug, that led the F.D.A. last year to reject the use of Avastin with Taxol or with the other chemotherapies for breast cancer.

In its appeal Genentech is changing its interpretation of its own data to pursue the case. Last year Genentech argued that the decrease in progression-free survival in its supplementary studies was not due to the pairing of Avastin with drugs other than Taxol. This year, however, in its brief supporting the appeal, Genentech argues that the degree of benefit may indeed vary with “the particular chemotherapy used with Avastin.” In other words, different chemotherapies suddenly do yield different results, with Taxol being superior. The same data now generate the opposite conclusion.

Perhaps more troubling is the resort to anecdote in the brief to the F.D.A. and in the news media.  Oncologists recounted their successes, and patients who were doing well on Avastin argued for its continued approval. But anecdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.

Avastin will not disappear because of the F.D.A. decision. It remains available for treating other cancers, and research to find its appropriate role in breast cancer treatment continues. In the meantime, the F.D.A., which is expected to make its decision in September, needs to resist Genentech’s attempt to have it ignore scientific evidence.

Serious progress in the treatment of cancer will not be the result of polemics, lobbying or marketing. Genentech’s money and efforts would be better spent on research for more meaningful treatments for breast cancer.

By: Frederick C. Tucker, Jr., Oncologist and Op Ed Contributor, The New York Times Opinion Pages, May 24, 2011

May 25, 2011 Posted by | Big Pharma, Capitalism, Consumers, Corporations, Government, Health Care, Health Care Costs, Health Reform, Pharmaceutical Companies, Politics, Public Health, Regulations, U.S. Chamber of Commerce, Women, Women's Health, Womens Rights | , , , , , , , , , , , , , , , , , | Leave a comment

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