They may look pretty enough to eat, but you really don’t want to be swallowing drugs spotted with paint. Do you? Or maybe you’ve already gobbled some down. It wouldn’t be all that unusual, according to this article from the Associated Press:

SAN JUAN, Puerto Rico (AP) — The first warning sign came when a sharp-eyed worker sorting pills noticed that the odd blue flecks dotting the finished drug capsules matched the paint on the factory doors.

After the flecks were spotted again on the capsules, a blood-pressure medication called Diltiazem, the plant began placing covers over drugs in carts in its manufacturing areas.

But the factory owner, Canadian drug maker Biovail Corp., never tried to find out whether past shipments of the drug were contaminated — or prevent future contamination, according to U.S. regulators.

Thirteen of the 20 best-selling drugs in the United States come from plants on this island. But an investigation by The Associated Press has found dozens of examples over four years of lapses in quality control in the Puerto Rican pharmaceutical industry, which churns out $35 billion of drugs each year, most of it for sale as part of the $300 billion market in the U.S.

This is pretty sad, if you ask me. How much money do pharma companies rake in, and they can’t even keep paint off their capsules? And the FDA–gee, maybe if they’d stop worrying so much about searching for elusive boxes of contaminated chamomile tea, ie, trying to put the herb and alternative medicine market out of business, they might find time to do their job.

This is another juicy little quip:

The FDA issued a warning letter to Wyeth in May 2006, after consumers reported finding machinery pins inside bottles of Effexor, a leading depression treatment, and the heartburn drug Protonix. The letter expressed concern that the plant was not “able to detect that the affected equipment was missing some of its parts.” The Madison, N.J.-based company faulted mistakes by workers who packaged the drugs.

They issued a warning letter after machinery pins were found in medication boxes. A warning! And such powerful language. Did the machinery need to be inside the drugs for them to take a little action? How about shutting down the factory? What about levying a stiff fine against Wyeth for not meeting quality controls? And maybe hiring workers with a little more intelligence, or teaching them the difference between a machinery pin and a capsule of medication.

There is no excuse for quality control at factories to be of the highest standards, and to be standardized across the board. No excuses. Every factory must meet them or be shut down until they do. And the companies should have to pay a stiff penalty for carelessness like this. And the FDA needs to do its job, not sit around and write wimpy little letters.

The article also says that some plants in Puerto Rico are three decades old. I guess that they haven’t been renovated since then, although I’m sure that none of the executives uses a company bathroom that’s gone 30 years without a tune-up, or has an office that hasn’t been redecorated in that time.

I have received several comments on my Aug 10 post about the recent court decision to deny terminally ill patients the right to potentially effective treatment–on the grounds that they are “experimental.” You know, the drug might turn out to cause impotence in male patients 20 years after taking it, so that is a major concern for a dying patient.

I have decided that this is a subject worth more than a passing mention, and will be revisiting it regularly. Who knows, I should start a whole new blog on it. That is something worth considering.

Please go and read the comments that people have posted. They are well thought out, poignant, and filled with very intriguing information. Especially about Provenge. It seems that the article I took the information from said that Provenge extended life 4.5 months. As a commenter posted, some patients have now survived 15 months longer than they should have. A drug that adds over a year of life of a dying patient should not be ignored or dismissed. But there may be some sinister underlying reasons.

This is a comment I received, and I think the information is worth reading. It is so typical of the FDA, and may explain the heart of the Provenge controversy. It is also frightening, to see just how much conflict of interest the FDA is steeped in.

Roxanne,

I am writing to you in response to your article, Dying? Tough Luck, dated August 10th, 2007. Dr. Howard Scher, as an employee of the FDA, has been granted a level of public trust and the stewardship of such a position demands the highest levels of ethical and moral conduct. Voting on and participating in an FDA advisory meeting in order to determine which drugs receive FDA marketing approval in which you play a decisive role in and in which you have a financial interest in (or counter interest in), is contrary to unbiased public concern and counter to the fiduciary duty Dr. Scher accepted as a special government employee and FDA panel advisor. Dr. Scher’s participation in the Provenge advisory panel is akin to a defendant’s own sibling participating on a jury resulting in a hung jury decision. Knowing of Dr. Scher’s close professional relationship to ProQuest Investments, how is the public to believe that the FDA made the correct decision? Surely you can see the travesty of his participation in this matter. Such conflicts of public and personal interest jeopardize the legitimacy of one proclaiming to act on behalf of the public’s best interests.

The fact that Dr. Howard Scher sits on an advisory board to ProQuest Investments and has been granted an ownership position in ProQuest Investments, a $1 billion venture capital fund which has a major financial ownership stake in Novacea, a direct competitor to Provenge, and is allowed to participate in and vote on marketing approval of Provenge is unacceptable ethically. Furthermore, Dr. Scher’s apparent over the top crusade to deny this choice to terminally ill patients for what appears to be financial gain is immoral in light of the lack of treatment options available to terminally ill androgen-independent prostate cancer (AIPC) patients and when considering the undeniable survival benefit demonstrated in combination with Taxotere, the only FDA approved treatment for AIPC.

The survival data shows that the patients that received Provenge had longer median survival (4.5 months) than that reported for Taxotere therapy, without having to endure 7 months of infusion therapy and coping with the poisonous toxic side effects related to Taxotere infusion. In support of its efficacy, a direct correlation between Provenge induction of immune response and survival benefit was also demonstrated in these patients. Most impressively, the data analysis also shows that when Provenge treated patients were subsequently treated with Taxotere, their median survival almost doubled (from 20 months to 35 months). This is compelling survival data further supporting the efficacy of Provenge for hormone refractory prostate cancer. In comparison, Taxotere increases median survival by only 2-3 months. This increase in survival is so dramatic and remarkable, it could not have been due to a random chance. This clearly shows that Provenge is effective at extending overall survival from AIPC beyond any reasonable doubt. This is amazing data.

Provenge received an overwhelming vote of support from the advisory committee and recommended immediate marketing approval be granted. Both Dr. Howard Scher and Dr. Maha Hussain, each of whom voted in the minority and are very powerful members of the oncology community, launched an unprecedented PR campaign accusing those in the majority of incompetence and naiveté in matters relating to cancer products. The arrogance of this campaign overlooked the notion that survival data from Provenge may be qualitatively different from, and may need to be judged by different criteria than, survival data from chemotherapy drugs (as recognized in a July 1st National Cancer Institute research report by Jeffrey Schlom, Ph.D., chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute).

A request for a Conflict of Interest Waiver was requested by Dr. William Freas, Director of Scientific Advisors and Consultants for CBER, on February 5, 2007. The request was concurred by Vince Tolino, Director of Ethics and Integrity, on February 26, 2007. On March 8, 2007, Dr. Howard Scher was granted a waiver by Dr. Randall Lutter to participate in Dendreon’s FDA advisory panel for Provenge because an individual with lesser conflicts of interest was unavailable. I don’t understand how the need for Dr. Howard Scher’s individual services could outweigh the above demonstrated conflict of interest created by the financial interest attributable to Dr. Scher. I can’t imagine an individual participant with more financial conflicts of interests sitting on the FDA advisory panel for Provenge. It is my fear that Dr. Scher’s financial interests have come before the best interests of terminal AIPC patients.

There must be standards to public duty and there must be accountability and consequences for failure to meet the necessary high standards. Maintaining the integrity and dignity of the FDA is essential for maintaining high levels of public confidence in our institutions of government.

Provenge should be approved now! Cancer patients and advocates will be holding an FDA rally September 18th raise awareness of the current situation and elicit change at the FDA. You can find out more at: http://www.arighttolive.com Please come support cancer patients September 18th. Every voice counts.

If you’re dying of some dread disease, and all of your options spent, and you weren’t lucky enough to qualify for a clinical trial–well, tough luck. Even if an experimental drug may help you, our court system and FDA has decided that you are better off dead than to dare use an unapproved drug.

This does go back to the militancy which developed early in the AIDS epidemic, when patients mobilized and demanded drugs be made available sooner. They didn’t have time to wait until the next century, until the FDA got around to giving potential life saving/prolonging drugs approved. But now it seems, we are back to square 1.

Granted, I think that in many cases, the FDA is far too lax in what is approved and what pharm companies are allowed to claim about their products. For starters, the FDA is a joke when it comes to post-marketing surveillance, although that is beginning to change. But what we have to realize is that most drugs approved these days are mostly for non-life threatening conditions. Some are mere remakes of older drugs, with a few new bells and whistles, and are really not essential in the grand scheme of things.

What I am now referring to are drugs for potentially lethal diseases, made available to dying patients who have run out of options and whose physicians feel that they may help this patient. These are experimental drugs, which are in clinical trials. The patient is willing to pay for them out of pocket, and is willing to take any risks (although, when you are soon to be dead, the word “risk” takes on a whole new meaning). But yet, a court decided today that a patient has no right to these drugs.

From the OC Register:

The U.S. Court of Appeals for the District of Columbia Circuit apparently believes that bureaucracies can and do have power so absolute that they trump the traditional right of free people to control their own bodies and try to protect their own lives. If that’s not the case, it’s difficult to see how the court arrived at the 8-2 decision in Abigail Alliance v. Eschenbach, which denies terminal patients and their doctors access to medications that have passed safety tests required by the Food and Drug Administration, but not the full battery of tests to prove efficacy.

The best course would be for the FDA to loosen up its restrictions on access to partially tested drugs, which lead to “thousands of people dying because of the FDA’s bureaucratic know-it-all attitudes,” as Paul Kamenar of the Washington Legal Foundation, which was co-plaintiff in the case, put it to us.

The next-best course (because it would take longer) would be for the U.S. Supreme Court to reverse this misguided ruling. Mr. Kamenar assured us that an appeal will be filed before the end of the month.

It’s one thing to deny a patient the use of an experimental acne drug, but a cancer patient? One dying of AIDS? One dying of a severe bacterial infection? Come on, let’s get real. This is about the cruelest and most devastating thing that the FDA has ever done. And apparently, the judges who ruled in favor of the FDA seem to think that they are invincible, and will never be a dying patient themselves, without options. Then again, when you are rich and well connected, having a connection to unapproved drugs isn’t a problem. It’s just the peons who will suffer.

“The FDA’s policy of limiting access to investigational drugs is rationally related to the legitimate state interest of protecting patients, including the terminally ill, from potentially unsafe drugs with unknown therapeutic effects,” Judge Thomas Griffith wrote in Tuesday’s majority opinion.

Does he really think that a person who is dying wants to be “protected” by the FDA, or by him for that matter? Do they care about the potential side effects? And the unknown therapeutic effects–gee, if it doesn’t work, they’ll just die, same as before. This paternalistic and arrogant attitude is mind boggling. Someone ought to lock this person in a room with a hundred dying patients, and then let him explain to them how his decision is “helping” them.

The FDA’s comments about this are priceless, but then, they always are. They never miss an opportunity to show their supreme stupidity, or how out of touch with reality they are. But I guess that it is their right to hold the power of life and death over defenseless patients. People should live and die by their word, it seems.

FDA spokeswoman Julie Zawisza said the agency was pleased with the appeals court ruling.

The decision “upholds the constitutionality of FDA’s role in facilitating appropriate treatment access to investigational therapies,” Zawisza said. It also protects the public by requiring that drugs be proven safe and effective before they are sold, she added.

Again, this protection bit. Did anyone explain to this chicklit that we are not talking about a treatment for nail fungus, but for diseases like cancer? That the word “protection” has little meaning to someone who is peering into their grave and doesn’t want to jump in like a good little patient.

On the bright side was the dissent by Judge Judith Rogers. “Denying a terminally ill patient her only chance to survive without even a strict showing of government necessity [for denying access to the drugs]presupposes a dangerous brand of paternalism.”

Right on sister, I couldn’t have said it better myself.

So where are out healthcare professionals? This is a volatile issue, but I haven’t seem much feedback on this coming from doctors and nurses. But some of them also seem to have this idea that a dying patient should be kept from their options.

From BusinessWeek:

Even cancer specialists, who often seek compassionate use programs for their patients, aren’t keen on expanded access. “I understand emotionally why patients would want this right, but the issues surrounding experimental drugs are very complex, and I think this could potentially backfire,” says leading oncologist Dr. George Demetri of the Dana-Farber Cancer Institute in Boston. “Patients really need to know the relative benefit of a drug versus the relative risk, and expanded access could prevent them from gaining that insight.”

Well gee, Dr. Demetri, then why not sit down and explain the relative risk of a drug to the patient. You know, spend some time with the patient, and go through it. Give them the lowdown. Expanded access is not going to prevent that from happening. The only thing that will prevent that is if doctors like yourself don’t take the time to confer with your patients.

Activist patients, however, are disinclined to wait for such data when it comes to diseases for which treatments are few to nonexistent. Prostate cancer patient advocates in particular are up in arms these days over the FDA’s controversial refusal in May to approve Dendreon’s (DNDN) Provenge without further clinical trials, which could take a year or more to complete. Provenge is a novel cancer vaccine meant to prime the body’s immune system to attack tumors, and if approved would have been the first new treatment in more than 20 years for advanced, stage-4 prostate cancer, which is almost always fatal. Some 30,000 men die each year in the U.S. from prostate cancer.

In a trial, Provenge failed to stop the disease from progressing, but when it dug into the data it found that patients on the drug lived an average of 4.5 months longer than those on standard treatment. Despite the uneven results, an FDA advisory panel voted 13-4 in March to recommend the drug for approval, and the FDA usually follows such recommendations. So when the agency withheld approval on May 9, a firestorm erupted. Prostate cancer activists (and disgruntled Dendreon investors) have lobbied Congress, held demonstrations, and met with the FDA’s Commissioner, Dr. Andrew von Eschenbach.

So now you have to wonder, why did the FDA withhold approval? It’s not like they’ve never approved a drug that was shown to be sketchy, or lacked solid safety data, or was shown to have minimal efficacy. They have also approved drugs that their advisory board turned down. So what’s up with Provenge? It’s not like people are just going to take it for the hell of it. The opportunity to live another 4 or 5 months is a real blessing to someone with a terminal illness. Is the FDA just trying to show how truly corrupt and cruel it can be?

Is it my imagination, or is there a serious lack of safety protocols in our food industry? It seems every other day there is something that is being recalled, or that has sent people to the hospital, or is contaminated with ghastly microbes.

Could it be that the safety enforcement is so lax because we don’t have a real agency that monitors this? I don’t consider political mouthpieces and industry puppets to be taking care of food and drug safety, do you? And certainly, the hallowed FDA gives these industries a tap on the knuckles when they should be giving them a kick in the ass and setting steep fines that really hurt.

Here’s the latest in recalls. Beware fans of canned chili, botulism is coming to get you!

From MedicalNewstoday.com:

The US Food and Drug Administration (FDA) is warning consumers not to eat certain brands of canned chili sauce because they could get botulism poisoning which can be fatal.

A couple in Indiana and two children in Texas are seriously ill in hospital after eating the affected products. This was confirmed after testing left overs in a refrigerator. They started getting ill between June 29 and July 9.

All of the affected products are made by the Castleberry Food Company in Augusta, Georgia.

The FDA has it in for cherries. Be careful, the next time you pop one in your mouth, because you never know when the FDA may creep up behind you and confiscate not only your bag of cherries, but your bank accounts and worldly possessions (yes, they have done so in the past, I kid you not).

Dr. Mercola, who is one of the larger thorns in the FDA’s ass, has some interested comments under the title “The FDA Has Blood on its Hands.”

Congressman Ron Paul (R-Texas) says, “enough is enough,” to the Big Pharma Bullies running the FDA. He has introduced bill H.R. 2117 (the Health Freedom Protection Act) into the House of Representatives, which would effectively stop the FDA from censoring truthful claims about the health benefits of dietary supplements.

He wants to put an end to the federal bureaucrats’ meddling with your right to choose healthy alternatives over harmful and deadly patent drugs, and believes Americans should not be prevented form learning about simple ways to improve their health.

This bill puts the burden of proof on the FDA/FTC when it comes to proving that a label or advertisement is false and misleading. As it stands now, the manufacturer has to satisfy an unobtainable standard of proof—as was the case with the American cherry growers a few years ago.

The FDA went on a witch-hunt after the growers used evidence from studies funded by the U.S. Department of Agriculture, to state that cherries have anti-inflammatory properties.

The FDA ruled that the cherry growers could not use that evidence to make these claims. Instead, the FDA approved another dangerous anti-inflammatory drug that went on to take the lives of some 20,000 Americans … Clearly, the FDA does not object to the spilling of blood in the course of maintaining the pharmaceutical status quo.

Big Pharma has the FDA firmly in pocket, and censoring vital information—like the fact that eating 20 cherries has the same effect as popping aspirin or a Cox-2 inhibiting drug—is their only way to stay in business! Perhaps bill H.R. 2117 can get enough traction to stick if enough of us stand firmly behind it, pushing at the rear.

So would you rather eat cherries or pop pills with toxic side effects? Pay for a bag of cherries, or get a second mortgage on your house to pay for the FDA approved drugs?

According to this article, eating 20 cherries has the same effect as popping aspirin or a Cox-2 inhibiting drug. And the FDA is trying its best not to let you find that out.

I don’t agree with everything that Dr. Mercola writes about, and certainly, I have no financial stake in his website or any of the products that he sells (I wish I did). But when it comes to the FDA, he certainly knows what he’s talking about, and always offers links to the data.

Here’s another tidbit for your Saturday morning pleasure. Over 80% of the FDA’s resources are geared toward the approval of new drugs, and only 20% for all the rest. Only 5% goes to drug safety. Think about that the next time you pop a pill. How safe and effective is it really?

Blood transfusions should be denied to anyone working at the FDA.
No, let them bleed to death. Hemorrhage and die. If they wish to keep our blood supply short for no reason at all, they should be the first to accept the consequences.

From UKGay.com: (actually an AP story)

Gay men remain barred from donating blood, the U.S. government said Wednesday, leaving in place a 1983 prohibition meant to prevent the spread of H.I.V. through transfusions.

The Food and Drug Administration reaffirmed the policy on its Web site on Wednesday, more than a year after the Red Cross and two other blood groups criticised the ban as “medically and scientifically unwarranted.”

“I am disappointed, I must confess,” said Dr. Celso Bianco, executive vice president of America’s Blood Centers, whose members provide nearly half the nation’s blood supply.

Before giving blood, all men are asked if they have had sex, even once, with another man since 1977, when the AIDS epidemic began in the United States, according to the drug agency.

So according to the FDA, all gay men, even if they’ve had sex once with another man who was HIV negative and used a condom, are a “risk” to the nation’s blood supply.

Or if the guy had sex with another man in 1979, and then decided he liked women better, and is HIV negative–the FDA also considers him “too risky” to donate blood.

The FDA, as they keep proving over and over, does not operate according to scientific data, common sense, or intelligence. This gay thing I assume is just part of the politics that has taken over the organization, and been responsible for most of their recent declarations–like that marijuana has no medicinal value, despite the IOM report saying the opposite and hundreds of scientific studies; their faltering on Plan B, and now gay men.

Politics and assuring the financial health of the industries that they are supposed to be regulating. What a great organization the FDA is. Well, my original remedies still hold. Send them to China where they know how to take care of corrupt officials. Make them eat the tainted pet food that they dragged their feet about, and still can’t come up with an explanation for it. And let them bleed to death. Deny anyone working at the FDA a blood transfusion.

Oh, you didn’t know that was what FDA stood for? Fools and Dorks Association, F**kers and Derelicts Anonymous…take your pick.

Here’s more news on the FDA. I still think the Chinese have the right idea, because someone or something needs to put a fire under their asses. The FDA doesn’t think it needs to respond to the pet food scandal, or to even respond to questions about their incompetence. They’re hoping that it will just disappear, and then they can along on their merry little corrupt ways.

From the North County Gazette:

A Congressional committee has given the U.S. Food and Drug Administration until June 1 to produce requested records concerning drug and food safety in the United States or they will subpoena them.

Rep. John Dingell, (D-MI) chairman of the House Energy and Commerce Committee and Rep. Bart Stupak, (D-MI) chairman of the Subcommittee on Oversight and Investigations, told Michael Leavitt, secretary of the U.S. Department of Health and Human Services that the FDA has failed to respond to requests of the committee and in some instances, has produced redacted records to the committee without any prior consultation on such redactions.

“Since the 110th Congress began, Committee has requested briefings, documents and information regarding a range of problems with the operation of the Food and Drug Administration”, the committee’s letter to HHS said. “With the exception of the January 23 request regarding the generic drug approval process and the provision of two food safety briefings, all of the other requests form this committee have been, at best, only partially answered and several have been ignored altogether. The requests for documents and information have been outstanding for one to three months”.

“The delays and quality of responses to the Committee’s requests concerning FDA are unacceptable”, the committee told the FDA. “With the exception of patient identifiers in medical records, all documents produced to the committee are to be unredacted”.

The FDA claims its been “as responsive as possible” to the document requests.

Well, maybe the FDA isn’t lying. Maybe their “response” is all that they are capable of. Otherwise, they will have to answer to all of the industries that they are trying to protect, and perhaps return some of the gold that they’re getting to grease their pockets?

Or maybe they are really are just too dumb to under the meaning of the word “response.”

Perhaps our own beloved FDA would shape up if there was actually something to fear, like some form of punishment for being corrupt, ignoring safety, and allowing thousands of people (and pets) to become ill and die because they don’t want to interfere with the financial well being of the industries they are supposed to be regulating.

This is what happens in China. Maybe we should ship our own sleazy FDA officials over there and let the Chinese take care of them.

From CBSNews:

The Chinese government has taken the tough-on-corruption stand to its ultimate conclusion, sentencing to death the former head of the food and drug administration for taking bribes to approve substandard medicines. At least 10 deaths have been linked to the scandal. According to The Associated Press:

The developments are among the most dramatic steps Beijing has publicly taken to address domestic and international alarm over shoddy and unsafe Chinese goods — from pet food ingredients and toothpaste mixed with industrial chemicals to tainted antibiotics.

Maybe if we locked our own FDA officials in a dungeon and forced them to consume all of the toxic crap that they allow in food, and consume all of the now-recalled drugs that they allowed to slip through in the face of damning evidence, things might change over there. Or force them to pay for medical treatment for people and pets harmed by their inactions and efforts to ensure high profits to the industry.

Although, I think the best option is to send them on a one way shuttle to Uranus. And give them some Vioxx and toxic pet food for the trip.

If you’re concerned about tainted pet food, the American Veterinary Medical Association has a comprehensive listing of all pet foods that have been recalled, plus ones that are now considered safe. If you click on the products listed, they give you a complete history of the recall, and why the product’s safety is questioned.

And of course, I can’t post anything about tainted pet food without once again mentioning how the FDA dragged its ass on this, how they waited weeks to act, and how they don’t seem to be doing anything to “regulate” the pet food manufacturers. I mean, that’s their job, isn’t it. Ooops, sorry, I forget. The FDA is supposed to be regulating the financial health of the industry.

Well now here is one of the all time dorkiest comments from the FDA, if such a thing is possible. This is from an article that appeared in the Indystar.com, about pet owners moving to making homemade food for their pets.

The FDA and the American Veterinary Medical Association are urging pet owners to switch brands if they are worried. The veterinarian group also warned that many common foods are not safe for pets, including salt, garlic, onions, grapes and chocolate.

Making pet food at home is “kind of like canning: You have to think about bacterial contamination. And how do you make sure it’s nutritionally appropriate and balanced for the animal?” said FDA spokeswoman Julie Zawisza.

Apparently Ms. Zawisza has never read a pet food label, because if she did, it would be impossible to make such an idiotic comment publically. Then again, the FDA makes many idiotic comments publically, and make fools and jackassess of themselves on a daily basis, and endanger the health and well being of the entire nation, so I guess that comment is in keeping with their policy.

What kind of bacterial contamination are we going to get in home cooked pet foods? That’s like saying we would all be better off eating food out of cans, rather than making fresh meals from scratch for ourselves and families. And as I said, it is frightening what the FDA “approves” as safe and nutritious for both humans and pets. Reading the labels on pet foods, even some of the fancy brands, is enough to make you ill. This whole pet food scandal has to do with wheat gluten, and pray tell, what is wheat gluten doing in pet food? It is there just as filler, so companies can save money by cutting back on meat and vegetables. That’s right, filler.

How do animals in the wild make sure that their meals are nutritionally balanced? I guess they confer with the FDA before eating. It is interesting to note, that the only animals that seem to develop “human diseases” like diabetes, cancer, heart disease, kidney failure, etc, are the ones in captivity and the ones being fed commercial food. Mammals are made to eat raw food. I do feed my cats raw meat (organic from Whole Foods), vegetables and vitamin supplements. I think that their diet is a lot healthier than the chemical stew of low grade and highly processed products that are contained in most commercial pet foods.

If you are going to use commerical pet food, only buy foods that are human grade, which means that they are fit for human consumption. And add fresh foods to the diet, if you are feeding them mostly dry kibble. I mean, how healthy do you think you would be if the only thing you ate was some processed dry crunchy stuff?

And maybe FDA maven Julie Zawisza, would like to be treated to a bowl of Meow Mix and milk. Why not? She thinks its so healthy.

I really am trying to focus this blog more on nursing stuff and less on general healthcare, but I just can’t help myself when I see the FDA stick another thorn up their ass. In this case, the FDA was aware that pet food may have been contaminated, but dragged their feet and didn’t act for several weeks. Meanwhile, pets became ill and died, thanks to the efficiency and compassion of our friends at the FDA.

From ABC news.com:

The expanding pet food recall is the latest example of a “broken food safety program,” says Sen. Dick Durbin, D-Ill., who asked why the recall has unfolded so slowly. Durbin asked the Food and Drug Administration’s top veterinarian if failing to recall tainted pet food until three weeks after the first suspicion of contamination was too long of a wait.

“I can’t answer that. I don’t know,” said the FDA’s Stephen Sundlof.

Now isn’t that an intelligent response. I mean, why should they know? They are only entrusted with ensuring food and drug safety for both humans and other mammals, but the best they can come up with is, “Duh…”

From the LATimes:

In announcing the Senate hearing last week, Durbin called the pet food inspection system “deeply flawed” and criticized the FDA’s response as “tragically slow.” He said he hoped to learn when the FDA learned of the contamination and who is inspecting pet food plants.

“What we see here is an indication of problems across the board with food safety — both human and pet,” Durbin said Saturday. “There are too many agencies, too many laws, too many committee chairmen and too many special interest groups, which results in a piecemeal and splintered approach to food safety.”

FDA officials could not be reached for comment Saturday.

Durbin said the Kansas facility where many of the products were made had never been inspected by the FDA. “I would be shocked if they inspected any pet facility,” he said.

The FDA has “the ultimate responsibility for the safety of pet food,” Durbin said, but leaves inspections of facilities to the states. He said he was told that Kansas had never inspected the facility.

Don’t you feel safe, knowing that the FDA is watching over food and drug safety?

Every official at the FDA, who had anything at all to do with this issue, or who has anything to do with pet food safety–like getting off their ass and inspecting pet food facilities–should be forced to eat the tainted pet food. Then if any of them are left alive, they should be arrested and held without bail, and charged with fraud (stealing taxpayer money and not doing their job), and everything else from corruption to negligence. And hopefully, all of them would be locked away for the rest of their pathetic lives.

And as I’ve said before, the FDA as we know it needs to be completely dismantled, everyone associated with it fired, and in its place, several new agencies introduced. One for drugs only, one for food only, one for alternative medicines, and maybe a separate one for veterinary. And all should have strict regluations that separate the agencies from the industries that they are supposed to be regulating. As it stands now, the FDA thinks that it is supposed to be regulating the financial health of the food and pharm industries. Have they taken any action against the pet food companies responsible for this? Heaven’s no, that might interfere with their profits. It’s bad enough that they were forced to recall the pet food–the FDA wouldn’t want to inflict any more pain and suffering on the poor industry…

Ohmigod, such a thing is unknown. The FDA is such a pure and pristine agency, dedicated to the health and well being of the poor ignorant consumer, and it is an agency free from any political or commercial bias. And their track record over the past several decades proves it.

Uh, that is the FDA of mythology. The real one smells worse than a dead fish that’s been marinating for 10 years in an open sewer.

So once again, another tale of woe. This time it concerns former commissioner Lester Crawford, who rather abruptly left his position without an explanation.

From the Seattle Times:

Former FDA Commissioner Lester Crawford pleaded guilty Tuesday to conflict of interest and false reporting of information about stocks he owned in food, beverage and medical-device companies he was in charge of regulating.

Crawford admitted to falsely reporting that he had sold or did not own stock when he continued holding shares in the firms governed by rules of the Food and Drug Administration. Beginning in 2002, Crawford filed seven incorrect financial reports with a government ethics office and Congress, leading to the charges.

Poor Les. The article says that he was all choked up when he spoke with the press. And now off he goes to the private sector. The ever revolving door between the FDA and the industry they are supposed to be regulating.

Sorry I’ve been so errant but the workload has been astronomical. Not that’s it’s a bad thing, because the money is great. But it hasn’t left me much time for blogging or doing my “creative” work, ie, non-medical.

But here’s a moment for celebration. The FDA has approved Plan B for women 18 years and up. A partial victory, and a semi-sad one. First, the most vulnerable group still has to get a prescription for it, and considering the sex ed in our country, they probably don’t even know it exists–except if they have savvy friends, a cool doctor, cool parents who realize that they may not be abstinent until they get hitched, or a good filter-free Internet connection.

The second sad part is that it’s still political. It’s an election year, the FDA was threatened with a lawsuit, and the action commissioner is not going to become permanent commissioner until he solves this issue. I have a strong feeling that even the pucker faced neo con cons decided that they have to pick their battled, and this was a relatively benign one. And so, the FDA was given the green light. Well, partial green light.

How many women became pregnant in the interim, when their pregnancy could have been prevented? How many of those fetuses were eventually aborted? Why doesn’t the FDA publish those statistics, of how their inaction and caving in to politics disrupted thousands of lives and destroyed thousands of fetuses? A great big duh for them.

It’s going to take more than approving over the counter status to save the FDA. This move doesn’t redeem them in any way, shape or form. If it wasn’t an election year, they’d still be whining and dawdling.

From MSNBC.com< :

WASHINGTON - Women may buy the morning-after pill without a prescription — but only with proof they’re 18 or older, federal health officials ruled Thursday, capping a contentious 3-year effort to ease access to the emergency contraceptive.

Girls 17 and younger still will need a doctor’s note to buy the pills, called Plan B, the Food and Drug Administration told manufacturer Barr Pharmaceuticals Inc.

The compromise decision is a partial victory for women’s advocacy and medical groups that say eliminating sales restrictions could cut in half the nation’s 3 million annual unplanned pregnancies.

Lester Crawford, better known as the ex-commissioner of the FDA, is being a bad boy. Santa’s not going to like that, and won’t bring him a bag of goodies. Plus, there seems to be a lot more than meets the eye, or the public as the case may be, regarding the approval of over the counter status for emergency contraceptive Plan B. The situation is getting as murky as it gets, even by FDA standards (and they have a pretty sleazy history.

The former commissioner of the Food and Drug Administration declined to cooperate with an inquiry by the Government Accountability Office into the agency’s controversial decision to reject nonprescription sales of an emergency contraceptive.

According to congressional staffers who have read the draft GAO report but were not allowed to copy it, the document has several footnotes indicating Lester M. Crawford did not respond to requests for an interview.

Okay, so what’s up with Lester? There have already been calls into investigating his resignation and the reasons behind it–one does not just abruptly resign as FDA commissioner as if it was a job delivering pizzas. Quitting a post that he apparently wanted, only two months into his tenure, is not a sign that all is well and honest. We already know that he lied to the Senate, about making a decision on Plan B, just to get himself confirmed–so this is definitely not an honest man we’re dealing with.

But wait, the whole situation with Plan B is beginning to stink, even worse than Lester Crawford’s dirty underwear.

The draft report, which is being reviewed by the FDA and members of Congress, describes the agency’s decision-making process on Plan B as highly unusual because officials in the commissioner’s office were directly involved and the FDA office directors who normally rule on applications refused to sign the rejection letter. An FDA advisory panel earlier voted overwhelmingly in favor of the proposal.

In addition, the GAO report indicates that the decision to reject the application was made months before it was announced in May 2004 by Steven Galson, then acting director of the FDA’s Center for Drug Evaluation and Research. The report says the rejection was discussed at a January 2004 staff meeting when Mark B. McClellan, now head of the Centers for Medicare and Medicaid Services, was FDA commissioner. It was unclear yesterday whether McClellan spoke with the GAO.

The GAO can demand documents from federal agencies but can’t force anyone to actually talk. So unless they kidnap Lester Crawford, tie him up and beat the crap out of him, he can refuse to discuss the subject.

The FDA also declined to respond to the GAO report. The agency has until Oct. 26 to comment on the findings, which are scheduled to be released next month.

You know, not only does the FDA need a new commissioner, its entire hierarchy needs to be dismantled and rebuilt. The organization as it exists now needs to be scrapped, and a real regulatory agency needs to be established in its place.

Washington Post

The mishandling of Plan B (the morning after-pill, emergency contraception, take your pick of names) at the FDA is the stuff that legends are made of. Their refusal to permit it to become available over the counter, and thus possibly preventing thousands of accidental pregnancies from occuring, is truly one of their darkest moments.

One FDA official has already resigned in protest of their treatment of Plan B. And now a second one bites the dust, for the same reason. The FDA is supposed to be a scientific organization with the mission of assuring food and drug safety, and acting in the best interest of the consumer. Not a dog and pony show.

Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine, said the agency is ignoring science in favor of politics in delaying approval of the drug for over-the-counter sales.

He was a member of the FDA’s Nonprescription Drugs Advisory Committee when it voted to approve Plan B for over-the-counter sales in 2003, and had served as a consultant to the committee since his term ended earlier this year.

Davidoff is the second person to publicly resign over Plan B. In late August, the top women’s health official at FDA, Susan Wood, also resigned in protest. Former FDA Commissioner Lester Crawford has also since resigned.

The reasons for Crawford’s abrupt resignation are yet to be determined, but he deliberately lied about it in order to get confirmed as commissioner. He promised to reach a decision on it by a certain date, but as soon as he had his confirmation in his hot little hands, he reneged on his promise.

Anyway, the FDA is still floundering around when it comes to Plan B. But maybe that’s the plan. All of the competent and ethical people will resign in protest, and then they can fill their ranks with political appointees (no matter whether or not they have any experience in science or medicine), and they can make decisions based on neo-conserative interpretations from the Bible. They can change their name to the Food and Drug Neo-Biblical Association. The FDNBA. Catchy name, huh.

Mercury News

Something really doesn’t smell quite right. Not that I have any remorse over Lester Crawford’s departure, but isn’t it a little bit strange that he would accept the post of commissioner only to resign two months later? According to Forbes.com, Lester says that he was “tired.” Poor dear.

Lester M. Crawford, who resigned as commissioner of the Food and Drug Administration last Friday, told Forbes.com that he decided to leave the agency because he was tiring after three years at the agency. He denies that financial conflicts of interest had anything to do with his decision to resign.

The article goes on to say that he considered retiring on Sept 1. Now, it isn’t like he stepped into the job in July and was stunned to find that he actually had to go to work and deal with all that goes with the FDA. He was already acting commissioner for two years, during which time he had plenty on his plate, including the Vioxx scandal, questions about suicide and antidepressants, and of course, that ever pesky morning-after pill. The position wasn’t new to him, and if he was so “tired” then why take the position?

In addition to being worn out by working 20-hour days, Crawford says several other factors contributed to his decision. First, there had been a great deal of controversy over decisions related to the “morning-after pill,” a form of birth control that Barr Laboratories (nyse: BRL - news - people ) has tried to take over the counter, and RU-486, the abortion pill. He says he didn’t feel ready to deal with another set of such controversies.

Please, the controversy over the morning after pill and RU-486 (something entirely different) did not crop up this month. Lester was dealing with them, or at least supposed to be, over the past two years. Nothing has occurred since July that wasn’t already ongoing at the FDA. None of the problems, scandals, and other issues.

So basically, it just sounds like a lot of bull. Maybe he took the position of commissioner so he could retire with a higher pension and better retirement package? Can’t rule that sucker out. Maybe Lester Crawford can get together with Michael Brown and they can start their own agency. Incompetent Fools, Inc. Now that has a catchy ring to it.

Sort of a new twist on the military’s policy for gay recruits, only in this case, I’m talking about the FDA. They don’t want you to ask, and they don’t want to tell. Anyone who’s been keeping tabs on the FDA for the past decade or two knows just how low they’ve dropped on the integrity scale, but it seems that they are now scraping bottom.

Traci Johnson’s body was discovered on Feb. 7, 2004, hanging by a scarf from a shower rod in an Indianapolis laboratory run by the drug company Eli Lilly. The 19-year-old college student had been serving as a test subject in a clinical trial of the experimental antidepressant duloxetine. Investigators from the Food and Drug Administration rushed to Indianapolis to determine whether the experimental drug was related to her death. The probe was inconclusive.

This left researchers in a quandary: Was the drug safe or not? Could duloxetine trigger suicide, as some experts suggested? Or was Johnson’s death an “isolated tragedy,” as Eli Lilly claimed? When drug manufacturers fail to publish negative study results, as studies show is often the case, the best source of information about these questions is the FDA. The agency—which was rocked last week by the sudden resignation of Commissioner Lester Crawford—requires companies seeking approval for a drug to provide data from randomized controlled trials, studies in which some patients are given the drug and others are given a placebo. But when researchers and the press started asking about duloxetine, the FDA didn’t scour its database and go public. It kept quiet.

An interesting article on Slate.com not only delves into the FDA’s desire to keep undesirable information secret, but also chronicles a very frustrated journalist’s attempt to delve into the truth.

Good reading for a Tuesday morning. It will make you want to clear out all of your prescription drugs and chuck them into the garbage bin.

Perhaps I am being too hasty in my judgement of the new temporary boss of the FDA, the man selected to fill the stinky shoes of the dear, departed Lester Crawford, but the signs are ominous. First, he was chosen by Bush, so that alone puts on the red alert. Second, and most importantly, one has to wonder how committed this man is to being commissioner.

The man chosen to run the Food and Drug Administration said Saturday that he would keep his job as director of the National Cancer Institute while serving as interim chief of the drug agency.

In an interview, the official, Dr. Andrew C. von Eschenbach, said he had a “100 percent commitment” to both jobs.

So Dr. von E thinks that he can be 100% committed to two, heavy duty full time jobs. How is that possible? Simple answer to that one–it’s not. In other words, Dr. von E is going to simply collect two salaries, which you and I are paying for with our taxes, and do a half-assed job at both places.

Neither of these positions can be done on a part time basis. They require the full attention of the person at the helm. And sorry to disappoint, Dr. von E, but you can’t do both. And Bush should have made it crystal clear–while you are temping at the FDA, you have to take a leave of absence from the NCI, without your paycheck.

Now, another minor teeny weeny issue. Conflict of interest. Oops, we forgot to notice that when appointing the good doc to this job. Yes, Virginia, there is a major conflict of interest here, because the NCI serves as a sponsor of many applications seeking permission from the F.D.A. to test cancer drugs in humans.

Moreover, a nationwide network of researchers created by the institute generates some of the data included in drug companies’ applications to sell cancer drugs.

In the interview, Dr. von Eschenbach said he would strike “an appropriate balance” in evaluating the risks and benefits of drugs.

Dr. von E just seems to be an all around Wonderboy, doesn’t he. He can handle two heavy duty full time positions as the head of two large institutes, and balance an obvious conflict of interest. He is just too cool for words. Maybe he’s really the $6 million man in disguise.

And one final note–I think Dr. von E’s brain has been abducted by aliens. The good doctor has declared a goal of “eliminating suffering and death due to cancer by 2015.” This statement has a lot of other cancer experts getting worried about the mental stability of their leader. Richard Nixon also declared “War on Cancer” around 1970, and the only victory claimed so far are a few minor battles. Cancer is alive, well and thriving 35 years later. And Dr. von E expects victory in 10 years.

His rationale is that prevention, early detection and new drugs, while not curing cancer, would make it more of a chronic disease. However, in order to make any inroads into preventing cancer, one would have to start taking action, like prohibiting carcinogens in food, force better protection of workers who are employed in areas where they are exposed to carcinogens, force factories to cut down on toxic emissions (Bush is currently doing the opposite), strengthen laws on polluting air and water (again, Bush is working hard to weaken laws), and so on. All of this involves trampling the feet of very powerful industries, which is why it hasn’t happened thus far.

So how does Dr. von E propose to prevent cancer, without taking any action? Stay tuned…although I have a feeling that the emphasis will be on new diagnostics, which only tell you that you have the disease and don’t prevent it, and new drugs for treatment. Preventing illness in the first place has always taken a back seat in our health care system.

But overall, I find this appointment an absolute disgrace. Even for Bush, it is shocking.

NY Times

Well well well. More good news over the transom. Lester Lying Fool Crawford has resigned as FDA Commissioner. Like a true fool, he claims that it is because of his age.

Embattled Food and Drug Administration Commissioner Lester Crawford resigned Friday, telling his staff that at age 67 it was time to step aside.

How convenient. He’s blaming his incompetence and inability to run the FDA as a science based government agency on his age. Is this man the ultimate of pathetic or what?

He also conveniently omitted mentioning that his tenure as commissioner was one of the lowest points in FDA history. His finest hour was backing down on his promise to reach a decision on the morning after pill, knowing that his confirmation depended on that promise.

Crawford’s three-year tenure at FDA was marked by increasing criticism, as the painkiller Vioxx was pulled off the market for safety problems, recalls of malfunctioning heart devices mounted and controversy grew over wider access to emergency contraception.

His resignation came just two months after the Senate, in a long-delayed move, elevated the longtime agency deputy and acting commissioner to the top job.

Last month, morale at the agency plummeted when Crawford indefinitely postponed nonprescription sales of morning-after contraception over the objections of staff scientists who had declared the pill safe. The FDA’s women’s health chief resigned.

I have no idea who is going to take his place, and it could be someone worse. But Crawford’s resignation is most welcome, and a celebration bash is in order. Getting rid of this dork is a major step forward for the FDA.

Seattle Times

I know, the headline makes you want to read it twice. Can the U.S. FDA really do something right, and that is in the interest of the public?

The FDA has approved the first generic versions of AZT, the grand old daddy of AIDs medications. It should be clarified that this is not the first version of the drug, but rather the first version that will be made available in the U.S. Glaxo’s patent has finally run its term, after 18 years, and like it or not, the FDA must allow the generics to move in. I should add that generic versions are already being manufactured in countries like India and China, where they can’t afford to pay the cost of patented medicine.

AZT currently costs about $2,200 for a one-year supply, far more than the average person in a developing nation could ever afford to pay. When AZT first came on the market in 1987, the price tag was about $10,000. So while the cost has declined dramatically, it’s still pricey, especially for people who don’t earn that much in a year. Generic versions of the drug cost as little as $105 for a one-year supply, and U.S.-made generics could be even cheaper than that. Now that will be a boon to saving costs in healthcare, wouldn’t it.

There have some fierce battles over patent vs. generic when it comes to AIDS drugs. Developing nations, home to about 80% of all AIDS cases, simply cannot afford to pay for patented drugs, even with discounts offered by the manufacturer. Thus, breaking patents and making generics was seen as a necessity by many developing nations, and I can’t blame them. I can understand a company wanted exclusivity after they put a drug on the market, but in the case of AIDS, the high prices simply meant that the majority of AIDS patients were just going to die untreated.

Just days after FDA commissioner Lester Crawford went back on his word about making a decision on the morning after pill, Susan F. Wood, director of the FDA’s Office of Women’s Health, resigned in protest. Here’s an interesting Q &A on her reasoning, and why she believes that it will be years (at least as long as Bush and his ilk are in charge) before the morning after pill will be available over the counter. Once again, the FDA shows what a lame excuse they are for a regulatory agency.

The interview is at Newsweek Health.