Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Thursday, September 18, 2008

Giuliani's Latest Project: Messing With Big Pharma

Rudy Giuliani played his part at the Republican convention and will probably be an intermittent surrogate for McCain in the next several weeks, but that isn't what will take up most of his time. Giuliani held onto his lobbying firm aptly named Giuliani Partners, albeit loosely while he was running for President. That's how he rakes in his cash, dealing with shady figures from around the world so they can have "Mr. 9/11" at their side. Giuliani will do anything for a buck and this week we learn he'll even go up against the U.S. Pharmaceutical industry to do so.

From BBC News:

Indian drug firm Ranbaxy has hired ex-New York City Mayor Rudolph Giuliani as an adviser, the company says.

The move comes a day after the US Food and Drug Administration (FDA) banned the import of more than 30 generic drugs made by the drug firm.

The FDA said it imposed the ban after it found manufacturing quality problems at two Ranbaxy factories in India.

Gee, how can Rudy Giuliani bring a pharmaceutical maker into compliance with the FDA? Apparently the FDA put the black mark on Ranbaxy for having unsafe conditions and contamination problems at their facilities. Will the Mayor go into the factory and shout "9/11, 9/11, 9/11" and make all violations go away?

Of course not, but it is important to remember that the FDA is run by a combination of Bushies and Pharmaceutical industry lobbyists. They don't care about unsafe conditions, just take a look at the dangerous drugs that have been allowed out into the market due to lax regulations. So what is the real problem here?

Well as Forbes points out, every single drug that was banned was being made by U.S. competitors. In fact, the only drug that was left on the shelves was Ganciclovir Sodium and no one in Big Pharma made it. The crony at the top of the FDA talked tough about safety and holding other countries up to high standards but she really isn't fooling anyone.

So the question is, what will Rudy do to grease the wheels at the FDA of the Bush Administration to help Ranbaxy out? I'm guessing that somehow, somewhere and some way, money and favors will be exchanging hands when and if Ranbaxy is suddenly found to be in compliance again.

Image from NY Mag

Thursday, September 11, 2008

Bush's Mismanaged FDA Endangers Our Health

dConservatives claim today that George Bush isn't really one of their own because the country has fallen so precipitously in so many regards. However, Bush does govern as a conservative and a radical one at that. Giving the government's responsibility to protect the people over to private industry has happened more rapidly in the last eight years than Reaganomics could hope for in the 1980s. Back then it was about giving back taxes to the wealthy and away from the programs to help the poor.

Now in 2008 the reforms of the 1930s and the progressive movement as a whole are under full-frontal assault. There are plenty of examples of this, the defense industry, airline safety and energy regulation to name a few. Every single sector of de-regulation is a serious national matter, but when it comes to the food we eat most Americans assume that the FDA and the USDA are looking out for our safety, but they'd be wrong. It isn't because the inspectors don't care, the reason is that there just aren't enough of them.

From US News:


From the first reports of a salmonella outbreak this spring, it took a full 89 days before jalapeƱo and serrano peppers correctly came under suspicion as the culprit. During that period, as more than 1,440 victims trickled in to hospitals, federal officials struggled to trace the source of the outbreak, erroneously singling out tomatoes for weeks before homing in on peppers. No sooner had that outbreak tapered off than the high-end Whole Foods Market was forced to launch a massive recall of E. coli-infested ground beef.

The incidents prompted renewed calls for reform and stricter oversight of food safety. Some lawmakers are even suggesting stripping the Food and Drug Administration and the U.S. Department of Agriculture of their inspection duties and giving them to a new agency. Yet the FDA in particular has long been starved of funding and understaffed. Its workload, meanwhile, is rapidly expanding as the global food chain grows larger, more complicated, and less transparent, all of which adds to the agency's already overcrowded plate.

Congress is under pressure to take up major food-safety legislation this fall that would offer sweeping proposals for regulatory change. The country's appetite for reform, however, is likely to collide with an uncomfortable reality: The responsibility for food safety, as it works today, lies heavily in private hands. Even as bacterial outbreaks have become more high-profile and the financial fallout from recalls more severe, the government has been handing off many food-safety responsibilities to industry. Food safety today is a business—and a booming one at that.


Now strict economic conservatives should deem this a good thing. Less government regulation means that private industry will step in and help keep our food safe. The problem is that like most of conservative ideology, the market doesn't care about our safety, it only cares about one thing, profit.

The counter-argument is that you can only profit if you keep selling food and that food has to be safe in order for people to buy it. Not so fast though, the evidence in the last few years has shown that these agribusiness giants have taken plenty of missteps at our expense and when people get sick (and some that die) the FDA is used as a scapegoat, but the real problem lays at the feet of the conservative policies in the last eight years and back during the eighties that helped to cripple the agency.

The market only cares about how to stay profitable and like the article states, retailers pay for inspections for crops that have had problems beforehand, not potential problems in the future. Here's an example. Say squash had a 0.01 percent chance of becoming diseased and that disease would kill 40 percent of the people that ate it. Meanwhile, spinach has a twenty percent chance of becoming infected but only harming ten percent of those that ate it and wasn't fatal. Retailers will spend the money on the spinach inspection because of the higher chance for an outbreak and not on the squash because ultimately the market deals looks at risk in the same manner as insurance companies set rates for clients. It always comes back to the profit motive, not the human-safety motive.

Now government regulation backed up by a strong budget to enforce it doesn't just go after past problems, it looks for all problems. The government is in place for the people (theoretically) and must respond to their wishes. Collectively we want our food to be safe, not just particular problem spots here and there around the farm. That is why Congress shouldn't go off and create a new agency, they should stick to the one they've got and make it effective again.

Tuesday, July 08, 2008

Bush Now Protects Personal Privacy....Of Tomatoes

A brilliant headline just in from Effect Measure on the status of the salmonella outbreak that had broken out on the national media stage and then disappeared. George Bush doesn't care about the privacy of Americans (except for those at telecom companies) but he does empathize with the infected tomato crop.

From Effect Measure:

The FDA and CDC still don't know the origin of the massive Salmonella outbreak, now extending to 40 states. They have lots of reasons, and under current conditions it's not an easy problem since the production channels for things like tomatoes are labyrinthine. There's lots of mixing, matching, diverting, and who knows what else going on as a tomato goes from a farm or hothouse to your table or local salad bar. We know this because FDA and CDC have been telling us so as explanation for why they still don't know where a single clone of Salmnella saintpaul has managed to infect almost 1000 people so far with no end in sight. You'd think that FDA and CDC would be anxious to make that job easier. Of course you'd be wrong:

Fruit and vegetable producers should be required to use technology allowing U.S. regulators to trace origins of contaminated produce such as tomatoes, considered the probable cause of a current outbreak, consumer groups said.

Failure to identify the source of a salmonella outbreak that has sickened at least 922 Americans since mid-April shows why ``emergency regulations'' are needed to put in place new food- safety rules, the Center for Science in the Public Interest and the Consumer Federation of America said today in a letter to Food and Drug Administration Commissioner Andrew von Eschenbach.

[snip]

Growers should be required to mark fruits and vegetables with bar codes on stickers so they can be traced back to the farm of origin, the consumer groups said. Similar programs are now used voluntarily by some restaurants and retailers, and a standard code on all FDA-regulated items would improve record- keeping and speed investigations, they said.

[snip]

Producers, packers, and processors should also be required to identify in writing gaps where contamination may occur in their operations and how to prevent it, the groups urged.

Kimberly Rawlings, a spokeswoman for the FDA, said she couldn't immediately comment on the groups' proposal.

The agency has favored voluntary guidelines over mandatory rules for food producers, even though certain producer organizations have backed tougher standards to improve consumer confidence in food products. (Catherine Larkin, Bloomberg)


So basically, to keep an anti-regulatory stance in the White House and it's agencies, they refuse to do everything in their power to look for the source of the outbreak. Voluntary rules will just not cut it. Agri-business does not want to wipe out anymore of their crops and they certainly won't regulate themselves. Believing that is worse than a forty year old waiting for Santa and the Easter bunny.

There are so many testaments to the complete and utter failure of the Bush Administration. This episode certainly ranks up there with the rest of the failing grades that George has "earned" in the last seven and half years.

Thursday, April 17, 2008

Why You Should Know What BPA Is

BPA, or bisphenol A is a word few have heard of, but nearly everyone in this country has come into contact with. Out of the thousands upon thousands of chemicals that are manufactured, this one helps make CDs, baby bottles, and everything else that is made with plastics. Plastics are used for nearly everything in our society. Now it turns out that the FDA covered up studies that linked the compound to cancer by using two other studies to show it was safe. Guess what, those reports were funded by the same companies that produce the materials.

From The Washington Post:

The draft report by the National Toxicology Program signaled a turning point in the government's position on bisphenol A, or BPA, a chemical so ubiquitous in the United States that it has been detected in the urine of 93 percent of the population over 6 years of age.

Last year, another expert panel using outside scientists minimized the health risks of BPA, but its findings were widely assailed after a congressional investigation found that a firm hired to perform scientific analysis was also working for the chemical industry.[...]

The FDA has been under fire from the House Energy and Commerce Committee, which has been investigating the influence of the chemical industry on the agency's regulation of BPA in plastic liners in metal cans of baby formula.

Last month, in response to questions from lawmakers, the FDA said it had disregarded hundreds of government and academic studies about the cancer risks of BPA and used just two studies funded by the chemical industry to determine that the chemical is safe.

Yesterday's report should spur the FDA to reconsider its decisions regarding BPA, said Reps. John D. Dingell (D-Mich.), the Energy and Commerce chairman, and Bart Stupak (D-Mich.), chairman of the panel's oversight and investigations subcommittee.


This is damning evidence should be spurring Congress to pull the products right off the shelf. Yet in our country where chemical industry lobbyists weld tremendous influence are trying to slow the investigations down. Of course they are deathly afraid of news like this, are quick to counteract.


But Steven G. Hentges, executive director of the polycarbonate/BPA global group at the American Chemistry Council, said the new report does not mean BPA is unsafe.

"It found no serious or high-level concerns for human health," he said. "More research is always considered valuable."


I wonder if that is "valuable" like the doctors who used to tell us smoking was o.k. and to drink during pregnancies long ago? The thing about this, BPA isn't as toxic as radioactive waste or Drano, but it does have an effect on the body. It is literally everywhere in our society. What we do about this omnipresent force is anyone's guess (perhaps working to ban it?). If the government won't handle it properly though, consumers must become pro-active and buy as many of their goods that are BPA-free as possible.